(90-55-3000) BIOLIS 50i - Operator's M - V5.7 PDF

Automated Clinical Analyzer
Operator ’s Manual
TOKYO BOEKI MEDISYS INC.

Original Instructions
Contact Address for System Trouble
We appreciate your adoption of our Automated Clinical Analyzer.

This system is produced under the severe quality control and production management.
But if the system has any trouble, please contact one of our offices without hesitation.
In case of trouble, we would like to ask you to let us know the following information,
which may make us rapid action.
Serial No.
Installation date
System Software Version
Status of the trouble including estimated cause of the trouble
Also if you have any question regarding analyzer function, or if you want to have
technical training information, please contact one of our offices .
Manufactured by Tokyo Boeki Medisys Inc.

1-14-21, Higashitoyoda, Hino-shi, Tokyo 191-0052, Japan
Tel: (81)-42-587-7777
V5.7
Caution
・This analyzer system may cause unpredictable accident or injury, it if is improperly installed
or improperly operated. Therefore, please follow the instruction of operation manual strictly.
・Please read the【Safety caution】 certainly, in advance. You should not do the following action,
without our approval beforehand.
・Modification for the analyzer
Addition of an attachment, supplied from the other maker than us.
・Self-repair or parts replacement
Self-adjustment of the points, assigned as qualified service engineer only.
・If you conflict the above, you may loose our assurance and maintenance agreement does not
cover the trouble.
・For the safety operation of the analyzer, it is necessary to do daily maintenance by yourself,
but also the inspection of the whole analyzer by a qualified service engineer, is necessary at the
time of consumable replacement or at the time of proper interval to keep smooth operation.
・For the accident or the trouble, without above inspection, we are not responsible.
・After analyzer installation has finished, if position movement, transfer, resale or abolition is
necessary, please let us know. If the above action has done without presence of qualified
engineer, we will not responsible for the accident or trouble after that.
・The maintenance function parts, which are necessary to keep analyzer function, will be stored
for 7 years after the sales date. If you want to have these parts over 7 years, please consult to
us within storage period.
・The contents of this operation manual and software specification may change without notice.
・If you find any defects or mistakes in this manual, please let us know.
© Copyright 2011 Tokyo Boeki Medisys Inc.

Original Instructions
Registered trademark
Windows is a registered trademark in the United States of American Microsoft Corporation and
other countries.
CSA Standard
This product meets the requirements of CSA.

“This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, second
edition, including Amendment 1, or a later version of the same standard incorporating the same
level of testing requirements”
Before the software installation, which is supplied from TOKYO BOEKI MEDISYS INC (TMS),
please read the following Software license agreement carefully. Software installation to a
computer is considered your agreement to the all items of Software license agreement. If you
find any objection, please let us know before installation.
Software license agreement

The purpose of this Software license agreement is to establish mutual agreement between
customer and TMS on license of the software which belongs to TMS.
1 The right to use

The word Software license agreement means the privilege to use the supplied software
from TMS.
2 License
2.1 TMS permits to the customer a privilege to use the software, supplied by TMS, under
the condition of Software license agreement, antimonopoly and non-transferring basis.
Note A privilege to use the consented software, means that the privilege to install the
supplied software on a computer, having recommended operating system, and run the
software on the computer.
2.2 All the privileges which are not included in Software license agreement are reserved by
TMS.
2.3 Any customer cannot do the following action such as: let a third party use the consented
software, disclose, takeout to the other countries by means of setting the re-use rights
and other methods.
3 Copyright
3.1 Copyright, trademark right, and intellectual property right related with consented
software and operation manual belong to TMS.
3.2 Any customer cannot do the following action, such as transfer, sublease, disclosure,
related to the consented software and operation manual, without written permission of
TMS in beforehand. No customer can set security interest.
3.3 Any customer cannot do the following action, such as partial collection, modification,
reverse engineering, reverse compile, reverse assemble for the consented software. If a
customer did the above and any trouble occurred on the analyzer, based on the
modification, TMS has no responsibility.
4 Reproduction prohibition
Any customer cannot copy the consented software, even though partly.
5 Guarantee and responsibility limit

5.1 TMS does not guarantee, no defect on consented software, and also we do not guarantee
that our analyzer system fits customer’s special needs, or useful for the needs.
5.2 TMS has no responsibility on the loss of customer or the third party, caused by the
V5.7
usage of consented software or related action. Also we have no responsibility on the

claims of a customer caused by the third party.
6 Forbidden items
Customer should not do the following action intentionally.
6.1 Transmitting harmful computer program, such as virus, to TMS or the third party.
6.2 The action violating the law and regulation.
6.3 The action inducing or promoting criminal acts and leading to criminal acts.
6.4 The action infringing copyright, trademark right, portrait right and other right and
profit of the third party.
6.5 The action of slander TMS or the third party and the action staining honor.
6.6 The action of publish or transmitting false information or information leading to

misunderstanding.
6.7 The action contrary to other public order and morals.
6.8 Other than the above items, any action which disturbs operation of TMS.
7 Effective period
7.1 This contract is active from the date of agreement, and active till failure of the contract,
by the procedure explained at the next article.
7.2 In spite of the above, the third article is active after the failure of the contract.
8 Cancellation of the agreement

8.1 If the customer violates this agreement, TMS can notice the cancellation of this
agreement without any notification. Other than that, TMS can demand on the loss,
caused by the violation.
8.2 The customer can cancel this agreement by the abandonment of the consented software.
9 The action after the agreement has over

When this agreement is cancelled based on the article 8, customer should abandon the
consented software and notify to TMS.
10 Conference
10.1 Regarding the subjects which are not covered by the agreement, customer and TMS
will discuss and reach to the conclusion by the basis of principle of good health.
10.2 If you have any question regarding the agreement, please contact to TMS by a
document.
Fast Detergent 2 5D Acid Washing Solution (CODE No. 50-24-0748), 2013/11/26 1/4
Date of revision : Jan. 30th, 2015
Safety Data Sheet

1. Product and Company Identification
Product name : Fast Detergent 2 5D Acid Washing Solution (CODE No. 50-24-0748)
Name of supplier : Tokyo Boeki Medisys Inc.
Address : 1-14-21, Higashitoyoda, Hino, Tokyo 191-0052, Japan
Division : Quality Assurance Group, Phone : +81-42-587-2965
2. Hazards Identification
GHS classification and label elements of the products
GHS classification
HEALTH HAZARDS
Skin corrosion/irritation : Category 2
Eye damage /eye irritation : Category 2A
Label elements
Signal word : Warning

HAZARD STATEMENT
H315 Causes skin irritation.
H319 Causes serious eye irritation
PRECAUTIONARY STATEMENT
Prevention
P264 Wash contaminated parts thoroughly after handling.
P280 Wear protective gloves , eye protection/face protection.
Response
P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P332 + P313 If skin irritation occurs: Get medical advice/attention.
P362 + P364 Take off contaminated clothing and wash it before reuse.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing.
P337 + P313 If eye irritation persists: Get medical advice/attention.
3. Composition/Information on Ingredients
Substance/Preparation: Preparation
General name : Nonionic surfactant、Organic acid (salt)、Metal corrosion inhibitor、
Antiseptic agent、Water
4. First-aid Measures
If inhaled
Move the victim to a place full of fresh air, rinse inside the mouth with water sufficiently and
keep at rest in a position comfortable for breathing. Get medical treatment, if necessary.
If on skin
Wash the affected area with a lot of cold water. Get medical treatment, if necessary.
If in eyes
If even a small amount of the product gets into eyes, immediately wash the affected eye by
flushing a lot of water for 15 minutes or more without rubbing (carefully wash eyeball and
eyelid completely). Get medical treatment by an oculist. In case you wear contact lens and can
take it off easily, you take if off and continue washing eyes.
If swallowed
Rinse inside the mouth with water sufficiently. If the patient is conscious, let the patient drink
fresh water or milk. Never force the affected person to vomit. Immediately get medical
treatment.
5. Fire-Fighting Measures
Suitable extinguishing media
This product is non-flammable. In case of a fire around the container, as a fire - extinguishing
agent that uses the water, dry-chemical powder or carbon dioxide.
Specific fire-fighting measures
Evacuate non-essential personnel to a safe area. Move container from fire area if it can be done
without risk
Special protective equipment and precautions for firefighters
Firefighters should wear proper protective equipment. Be careful not to inhale smoke and
must work on the windward side of the fire.
6. Accidental Release Measures

Personnel precautions, protective equipment and emergency procedures
Evacuate non essential personnel. Wear proper protective equipment.
Environmental precautions
Be careful not to dispose such chemical product into the rivers to cause bad influence on
peripheral area.
Methods and materials for neutralization, containment and cleaning up
Collect the leakage as much as possible and wipe off some remaining liquid on the floor or
ground with some pieces of waste cloth. Burn out such clothes. If the leakage cannot be
recovered, discharge them into a pit by flushing with a lot of water.
7. Handling and Storage

Precautions for safe handling
Preventive measures (Exposure Control for handling personnel)
Wear proper protective equipment.
Safety treatments
Avoid contact with skin. Avoid contact with eyes.
It is not allowed to fall down, it drops, the impact is added, and uncouth handling of product etc.
is done again.
Recommendation for storage
Keep the agent away from direct sunlight and store it in a cool place with the plug of container
tightly closed. Keep out of the reach of children.
8. Exposure Control/Personal Protection

Exposure controls.
Appropriate engineering controls
Good general ventilation should be sufficient for most conditions.
Install a facility for washing hands, eyes or bodies near the handling place. Put a notice to
indicate there is such a facility.
Individual protection measures
Respiratory protection Wear a protective mask.
Hand protection Wear suitable gloves such as rubber gloves.
Eye protection Wear protective eyeglasses or chemical safety goggles.
Skin and body protection Protective boots, protective clothes, protective rubber apron if necessary.
9. Physical and Chemical Properties

Appearance : Colorless transparent solution
pH : 2.5 （central value）
Specific gravity : 1.01 (central value)
Solubility : Dissolvable in water and hot water
10. Stability and Reactivity

Chemical stability
Stable under the normal storage/handling condition.
This material generates heat by neutralization with an alkaline substance.
Possibility of hazardous reactions
Metallic tools other than stainless steel (SUS304, 316) may be affected. Before using, be sure to
have a test of any metals.
Dangerous materials if mixed with
As this material is acidic solution, harmful gas may be produced if mixed with chlorine
compound, such as, sodium hypochlorite. Never let it be mixed with such items
Conditions to avoid
Sunlight, heat
11. Toxicological Information

Information on toxicological effects
Acute toxicity No data available yet.
Irritant properties
Skin corrosion/irritation Skin irritation
Serious eye damage /irritation Serious eye irritation
Allergenic and sensitizing effects No data available yet.
Mutagenic effects No data available yet.
12. Ecological Information

Ecotoxicity
Aquatic toxicity No data available yet.
Persistence and degradability No data available yet.
Bioaccumulative potential No data available yet.
Other adverse effects No data available yet.
13. Disposal Considerations

Waste treatment methods
This substance is acidic. Dilute this substance with a large amount of water before disposing. Or,
gradually neutralize it with some alkaline substance and then discharge with a large amount of
water.
In case of bulky lot, ask a professional industrial waste disposing company.
14. Transport Information

Special precautions in connection with transport or conveyance
In transporting the product, keep away from direct sunlight, check to see that no leakage from
the container occurs. Load the containers so that they may not topple over, fall down, or be
damaged, and take measures against collapse of the pile of the containers.
International rule
United Nation’ s classification / United Nation’ s number : Not applicable
IATA Dangerous Goods Regulations : Not restricted
15. Regulatory Information

Industrial Safety and Health Law, Japan ：Chemical name et al should be informed Not applicable
(Clause 57, item 2, enforcement regulations No.18, item 2 Attached list No.9)
Pollution Release and Transfer Register (PRTR) Law, Japan ：Not applicable
Poisonous and Deleterious Substances Control Law, Japan ：Not applicable
Fire service law, Japan ：Not applicable
Dangerous Substances Shipping and Storage Rules, Japan ：Not applicable
Civil Aeronautics Law, Japan ：Not applicable
16. Other Information/References

Reference Book
Globally Harmonized System of classification and labelling of chemicals, (4th Ed., 2011), UN
Recommendations on the TRANSPORT OF DANGEROUS GOODS 18th edit. 2013 UN
Classification, labelling and packaging of substances and mixtures (table3-1 ECNO6182012)
2012 EMERGENCY RESPONSE GUIDEBOOK(US DOT)
2014 T LV s and B E Is.(A C G IH )
http://m onographs.iarc.fr/m onoeval/grlist.htm l
JIS Z 7253 2012 H azard com m unication of chem icals based on G H S-Labelling and Safety D ata Sheet(SD S)
Supplier's data/inform ation
A boutthe lim iting of the responsibility:

T he contents m entioned have been prepared based on the m aterials, inform ation and data
presently available. It therefore, m ay be revised according to any new ly obtained inform ation or
know ledge from tim e to tim e.It does not guarantee the correctness and perfection of inform ation
or perform ance of any product. A ny precautions given therein are for an ordinary handling. If a
specialhandling is to be taken,be sure to provide w ith suitable safety m easure on new use/usage.
T he notification given therein regarding the danger and toxicity m ay not be sufficient, so handle
such item very carefully.
F ast D etergent 1 2.5D A lkaline W ashing S olution (C OD E No. 50-24-0747), 2013/11/25 1 /4
D ate of revision : J an. 29 th, 2015
S afety D ata S heet

1. P r oduct and C om pa ny I dentification
Product name : F ast D etergent 1 2.5D A lkaline W ashing S olution (C OD E N o. 50-24-0747)
N ame of supplier : T ok yo B oeki M edisys I nc.
A ddress : 1-14-21, H igashitoyoda, H ino, T ok yo 191-0052, J apan
D iv ision : Q uality A ssurance G roup, Phone : +81-42-587-2965
2. H azar ds I dentification
G H S classification and label elements of the products
G H S classification
HE A L T H HA ZA R DS
S kin corrosion/irritation : C ategory 2
E ye damage /eye irritation : C ategory 2
E N V I R ON M E N T H A Z A R D S
H azardous to the aquatic env ironment-acute tox icity : C ategory 3
L abel elements
S ignal w ord : W arning

HA ZA R D ST A T E M E NT
H 315 C auses skin irritation.
H 319 C auses serious eye irritation
H 402 H armful to aquatic life
PR E C A U T IO N A R Y S T A T E M E N T
Prev ention
P273 A v oid release to the env ironment.
P264 W ash contaminated parts thoroughly after handling.
P280 W ear protectiv e glov es, eye protection/face protection.
R esponse
P302 + P352 I F ON S K I N : W ash w ith plenty of soap and w ater.
P332 + P313 If skin irritation occurs: G et medical adv ice/attention.
P362 + P364 T ake off contaminated clothing and w ash it before reuse.
P305 + P351 + P338 I F I N E Y E S : R inse cautiously w ith w ater for sev eral minutes. R emov e
contact lenses, if present and easy to do. C ontinue rinsing.
P337 + P313 If eye irritation persists: G et medical adv ice/attention.
D isposal
P501 D ispose of contents/container in accordance w ith local/national regulation.
3. C om position/I nfor mation on I ngr edients

S ubstance/P reparation : Preparation
G eneral name : N onionic surfactant、M etal sealing agent、Water soluble solv ent、Water
4. F ir st-aid M easu r es
I f inhaled
M ov e the v ictim to a place full of fresh air, rinse inside the mouth w ith w ater sufficiently and
keep at rest in a position comfortable for breathing. G et medical treatment, if necessary.
I f on skin (or hair)
Wash the affected area w ith a lot of cold w ater. G et medical treatment, if necessary.
F ast D etergent 1 2.5D A lkaline W ashing S olution (C OD E No. 50-24-0747), 2013/11/25 2/4
I f in eyes
I f ev en a small amount of the product gets into eyes, immediately w ash the affected eye by
flushing a lot of w ater for 15 minutes or more w ithout rubbing (carefully w ash eyeball and
eyelid completely). G et medical treatment by an oculist. In case you w ear contact lens and can
take it off easily, you tak e if off and continue w ashing eyes.
I f sw allow ed
R inse inside the mouth w ith w ater sufficiently. If the patient is conscious, let the patient drink
fresh w ater or milk. Nev er force the affected person to v omit. Immediately get medical
treatment.
5. Fire-Fighting Measures
S uitable ex tinguishing media
T his product is non-flammable. I n case of a fire around the container, as a fire - ex tinguishing
agent that uses the w ater, dry-chemical pow der or carbon diox ide.
S pecific fire-fighting measures
E v acuate non-essential personnel to a safe area. M ov e container from fire area if it can be done
w ithout risk
S pecial protectiv e equipment and precautions for firefighters
F irefighters should w ear proper protectiv e equipment. B e careful not to inhale smoke and
must w ork on the w indw ard side of the fire.
6. Accidental Release Measures

Personnel precautions, protectiv e equipment and emergency procedures
E v acuate non essential personnel. W ear proper protectiv e equipment.
E nv ironmental precautions
B e careful not to dispose such chemical product into the riv ers to cause bad influence on
peripheral area.
M ethods and materials for neutralization, containment and cleaning up
C ollect the leakage as much as possible and w ipe off some remaining liquid on the floor or
ground w ith some pieces of w aste cloth. B urn out such clothes. I f the leakage cannot be
recov ered, discharge them into a pit by flushing w ith a lot of w ater.
7. Handling and Storage

Precautions for safe handling
Prev entiv e measures (E x posure C ontrol for handling personnel)
W ear proper protectiv e equipment.
S afety treatments
A v oid contact w ith skin. A v oid contact w ith eyes.
I t is not allow ed to fall dow n, it drops, the impact is added, and uncouth handling of product etc. is
done again.
R ecommendation for storage
K eep the agent aw ay from direct sunlight and store it in a cool place w ith the plug of container
tightly closed. K eep out of the reach of children.
8. Exposure Control/Personal Protection

E x posure controls
A ppropriate engineering controls
G ood general v entilation should be sufficient for most conditions.
I nstall a facility for w ashing hands, eyes or bodies near the handling place. Put a notice to
indicate there is such a facility.
Indiv idual protection measures

R espiratory protection W ear a protectiv e mask.
H and protection W ear suitable glov es such as rubber glov es.
E ye protection W ear protectiv e eyeglasses.
S kin and body protection Protectiv e boots, protectiv e clothes, protectiv e rubber apron if necessary.
9. P hy sical and C hem ical P r oper ties

A ppearance : C olorless transparent solution
pH : 11.1 （central v alue）
S pecific grav ity : 1.03 (central v alue)
S olubility : D issolv able in w ater and hot w ater
10. S tability and R eactiv ity

C hemical stability
Stable under the normal storage/handling condition. T his material generates heat if contacted by
acidic substance. A v oid mix ing w ith a highly acidic substance such as concentrated sulfuric acid.
Possibility of hazardous reactions
M etallic tools other than stainless steel (S U S 304, 316) may be affected. B efore using, be sure to
hav e a test of any metals.
C onditions to av oid
S unlight, heat
11. T ox icological I nfor m ation

I nformation on tox icological effects
A cute tox icity N o data av ailable yet.
I rritant properties
S kin corrosion/irritation S kin irritation
S erious eye damage /irritation S erious eye irritation
A llergenic and sensitizing effects N o data av ailable yet.
M utagenic effects N o data av ailable yet.
12. E cological I nfor mation

E cotox icity
A quatic tox icity H armful to aquatic life
Persistence and degradability N o data av ailable yet.
B ioaccumulativ e potential N o data av ailable yet.
Other adv erse effects N o data av ailable yet.
13. D isposal C onsider ations

W aste treatment methods
T his substance is alkaline. D ilute this substance w ith a large amount of w ater before disposing.
Or, gradually neutralize it w ith some acidic substance and then discharge w ith a large amount of
w ater.
I n case of bulk y lot, ask a professional industrial w aste disposing company.
14. T r anspor t I nfor mation

S pecial precautions in connection w ith transport or conv eyance
I n transporting the product, keep aw ay from direct sunlight, check to see that no leakage from
the container occurs. L oad the containers so that they may not topple ov er, fall dow n, or be
damaged, and take measures against collapse of the pile of the containers.
I nternational rule
United Nation’ s classification /United Nation’ s number : Not applicable
IATA Dangerous Goods Regulations : Not restricted
15. R egulator y I nfor m ation

Industrial Safety and Health Law, Japan ：Chemical name et al should be informed Not applicable
(Clause 57, item 2, enforcement regulations No.18, item 2 Attached list No.9)
Pollution Release and Transfer Register (PRTR) Law, Japan ：Not applicable
Poisonous and Deleterious Substances Control Law, Japan ：Not applicable
Fire service law, Japan ：Not applicable
Dangerous Substances Shipping and Storage Rules, Japan ：Not applicable
Civil Aeronautics Law, Japan ：Not applicable
16.O ther Inform ation/R eferences

Reference Book
Globally Harmonized System of classification and labelling of chemicals, (4th Ed., 2011), UN
Recommendations on the TRANSPORT OF DANGEROUS GOODS 18th edit. 2013 UN
Classification, labelling and packaging of substances and mixtures (table3-1 ECNO6182012)
2012 EMERGENCY RESPONSE GUIDEBOOK(US DOT)
2014 TLVs and BEIs. (ACGIH)
http://monographs.iarc.fr/monoeval/grlist.html
JIS Z 7253 2012 Hazard communication of chemicals based on GHS-Labelling and Safety Data Sheet (SDS)
Supplier's data/information
About the limiting of the responsibility:

The contents mentioned have been prepared based on the materials, information and data
presently available. It therefore, may be revised according to any newly obtained information or
knowledge from time to time. It does not guarantee the correctness and perfection of information
or performance of any product. Any precautions given therein are for an ordinary handling. If a
special handling is to be taken, be sure to provide with suitable safety measure on new
use/usage.
The notification given therein regarding the danger and toxicity may not be sufficient, so handle
such item very carefully.
Operator’s Manual Preface
Preface
Multi-items automatic analyzer is an analyzer designed as laboratory use bio-sample

analyzer, based on colorimetric, turbid metric and electrode method. Application targets
are clinical laboratory of hospital, clinical chemistry, immune-assay, urine testing.
This operation manual is composed of the following contents.
Preface
Alarm code, guarantee, safety and caution for operation
Chapter1 [Outline]
Chapter2 [Function and principal]

Various functions, operating principle and operation method are explained.
Chapter3 [Analysis operation]
Chapter4 [Screens and Programming]
Chapter5 [Maintenance]
Chapter6 [Check Flag・Alarm Function]

Explanation on the alarm messages and on the action to take as the
preparation of alarm massage appears.
Parts List
Periodic Check List
0-1
V5.7
0-2
1. Expression of Warning and Notice
In this manual, the items you have to be careful for safety are indicated by the following
levels.
Classification of display
Caution ：If ignored, the accident may cause personal injury or heavy damage on the
instrument.
Warning ：If ignored, the accident may lead to death or heavy injury.
Note ：Pay attention, additional explanation.
Description of the mark
：Biohazard.
There is the risk of your being infected.
In case of treating samples that may be hazardous or infectious, wear rubber
gloves not to touch directly.
Any spills on the skin should be washed off with a great volume of water and
sterilized.
And consult a physician if necessary.
Also any spills on the system should be wiped off and sterilized at once.
：This mark means electric shock if touched.
：This mark means laser light leakage. Do not see by naked eye.
：This mark means high temperature. Keep out from burn.
：This mark means do not touch with wet hand.
：This mark means electric ground is necessary.
：This mark means to protect eye, wear protective goggle.
：This mark means do not touch with naked hand.
0-3
V5.7
Explanation of caution and warning seal
The following seal are stuck on the analyzer body as warning.

If this mark is attached to the analyzer, read the corresponding caution of the
operation manual. Never remove these seals for safety protection.
1) Warning label on the back of the analyzer
Connection, Biohazard
If you operate the dangerous parts, please wear
glove.
Location: Water supply and drainage panel
2) Warning label inside the back of the unit
High temperature hazard

Scald by high temperature
If you operate the parts, turn off the main breaker
of the machine and disconnect the cable.
Location: trance
Electric shock hazard

Electric shock hazard of High voltage
If you operate the parts, turn off the main breaker
of the machine and disconnect the cable.
Location: AC power supply
0-4
3) Warning label on the side of the machine
Electric shock hazard

Electric shock hazard of High voltage
If you operate the parts, turn off the main breaker of the machine and disconnect the
cable.
Location: main switch (right side), WSH (High voltage circuit)
Hazardous moving parts

Do not touch the cooling fan.
cable.
Location: the cooling fan for peltire device
0-5
V5.7
4) Upper panel warning label
Revolution, vertical movement hazard

Some units rotate and move up and down.
Location：STM, STM for ISE, RTM1, RTM2, CWS, MU1, MU2
High temperature hazard

Scald by high temperature
cable.
Location: Lamp house (Lamp)
Biohazard
If you operate the dangerous parts, please wear glove.
Location: Sample tray, Reagent tray
Laser radiation hazard

There is Laser radiation port.
Location: Sample tray, Reagent tray.
0-6
5) Warning label of top cover
Revolution, vertical movement hazard

Some units rotate and move up and down.
Location: top cover
6) Warning label of reaction waste tank
Biohazard
If you operate the dangerous parts, please wear glove.
Location: Reaction waste tank
0-7
V5.7
7) Warning label of each parts
There are some warning labels. If you operate those parts, do not forget turn off
the main breaker.
Location: STM, RTM1, RTM2, MU1, MU2, CWS, DP, STM for ISE, STF, RGT,
CLB
High voltage circuit

Red frame shows high voltage area when analyzer is running. Never touch while running.
1. Dangerous area of RGT circuit diagram
2. Dangerous area of WSH circuit diagram
0-8
3. Dangerous area of water supply circuit diagram
Dangerous area
0-9
V5.7
4. Dangerous area of analyzer body circuit diagram
0-10
Position of dangerous moving parts
Red frame shows dangerous moving parts. Never touch while running.
1. STF
2. STM
3. RGT
4. RTM-1
0-11
V5.7
5. RTM-2
6. MU-1
7. MU-2
8. CWS
0-12
High temperature parts

Red frame shows high temperature parts. Do not touch while running.
If you need to touch, wait 10 minutes after turning off the main breaker.
1. Lamp house
2. Trans
3. Rotary motor (Reaction Tray)
4. Up/down motor (Sample probe)
0-13
V5.7
5. Up/down motor (Reagent probe1)
6. Up/down motor (Reagent probe2)
0-14
2. Safety caution・Precautions for use
Caution
(1) Electric shock protection

・ For protection against electric shock, operators shall not open any
(screw-fixed) covers, other than specified. Authorized engineer, by TBMS,
can open covers.
(2) Application range

・ This analyzer is used for tests of liquid sample using liquid reagent and type of tests are
clinical chemistry, immunoassay and ion concentration. If analyzer is used for
application other than the above, we are not responsible for the results.
Warning
(1) Moving parts while in operation

・ Do not open any cover while in operation. If someone touch sample
probe, reagent probe, washing mechanism, sample tray, reagent tray,
and reaction tray, may cause injury.
・ Never remove protection parts and cancellation of safety system.
・ Noise level of this analyzer is less than 70dB(A), while running.
(2) Lamp and Barcode reader (Laser class2)

・ Do not see optical source lamp and barcode reader (Laser class 2) by
naked eye directly. It may harm eye.
・ If it is necessary to handle, wear ultra-violet light protective glass.
・ Temperature of optical source lamp is very hot. Handle with care.
(3) Specimen handling

・ Do not touch specimen directly. When you handle specimen wear rubber
globe. If analyzer is contaminated by a specimen by mishandling,
wipeout by 70% ethanol solution and wipeout by water thoroughly.
・ Confirm that no clot is contained in specimen.
・ Consumable parts, which contact with specimen directly, such as sample
cup and probe, and other parts, which may be contact with specimen,
should be discarded as biohazard waste.
・ Should not leave samples in open air for long time. Evaporation
protection is necessary.
・ High viscosity sample may give poor result, because of clogging.
(4) Waste handling

・ The content of waste bottle contains sample, which may cause infectiou
disese. When you dicard these waste, follow the instruction of qualdied
0-15
V5.7
operater and related law.

Some reagent, standard sample and control sample may contain
regulated substance. When discard, consult to the maker about
regulation for these substance.
・ Reagent may contain poisnous substance. When discard, consult to the
maker about regulation for these substance.
・ Strictly follow laws and regulations of your country when discarding
waste water, reagents and samples
・ If you discard from the waste fluid mouth on the back of the machine,
strictly follow laws and regulations of your country.
(5) Test data accuracy

・ To keep test data accuracy, do QC control sample measurement periodically.
(6) Inflammable material

・ Do not use inflammable material around the analyzer, to protect from fire
or explosion.
(7) Alarm marking

・ If alarm mark label has peeled off from an analyzer, please let us know. We will supply
new label.
(8) Operation method

・ Analyzer operation should follow to operation manual. Operation, which is not
described in operation manual, may cause analyzer trouble.
(9) Power supply plug

・ Do not connect or disconnect power supply plug with wet hand.
・ Do not pull cords when disconnecting power supply plug.
・ It probably causes electric shock.
(10) Grounding
・ Securely connect PE conductor of power supply cord to protective earth
ground of building installation. The resistance to ground should be less
than 10 .
・ This analyzer corresponds to Equipment Class 1.
・ Customer should not change power supply code by yourself.
If you find a scratch or cut, please let us know.
(11) Installation condition, operating condition

Install the analyzer in accordance with rules of this manual.
(12) Position movement or abandonment

・ If you do not use the analyzer or move to another place or abandon, do
biohazard removal treatment.
・ Waste bottle, reaction cell, electrods, sample container and so on are
classified as infection bio-waste. When you abandon these parts, follow
0-16
the instruction of qualified operater and safty control procedure of the

institution.
・ Strictly follow laws and regulations of your country when discarding
contaminated parts such as waste bottle, reaction cell, electrodes,
sample container etc.
(13) Qualified operator

・ Operator has to take training course run by TBMS or its representative.
・ When analyzer used for clinical testing, operate under the medical doctor or clinical
testing engineer.
(14) Maintenance
・ When do maintenance follow this operation manual, and never touch other than
designated part.
・ When do maintenance operation, wear protective globe to avoid infection.
・ When you need to replace parts or units, please use parts and units supplied from us.
The maintenance operation done by a common operator are limited in the range of
operation manual.
・ Do not disassemble the analyzer.
・ For the electric shock protection, operator should not open front cover, back cover, left
and right covers. Authorized engineer, by TBMS, can open covers.
・ When analyzer is running, never open top cover. If an operator touch one of moving
parts, may cause trouble.
・ Before using an attachment, You have to read an operation manual of the attachment.
(15) Limitation for usable reagents

・ Do not use organic solvents because reaction cell, sample cup, waste line tubes are not
resistive enough for these solvents.
・ Please avoid cloggy samples and reagents.
・ Reagents and control serums, supplied from reagent maker, use properly, following to
the maker’s instruction.
・ As for reagent, use extracorporeal diagnostic medicines grade.
(16) Top cover

・ When close the top cover, do it slowly, so that avoid to put a finger.
・ Do not put anything on top cover, specially no liquid, which may intrude into analyzer.
(17) Tube
・ When installation or liquid handling is done, watch tubes are not collapsed.
(18) Cleaning solution and standard sample

・ As cleaning solution, and calibration use the cleaning solution and calibration supplied
from TBMS.
The quality of cleaning solution effects reproducibility of test results.
・ When fill up cleaning solution into the bottle, wear globe and do carefully not to spill
the solution.
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V5.7
(19) Static charge

・ Do not touch analyzer with a hand having static charge. Anybody having static
charge should be keep away.
(20) Emergency
・ For emergency stop, turn off main breaker at the back panel.
・ To do the above smoothly, keep the space at the back.
(21) Humidifier
・ Do not use a humidifier, an ultrasonic humidifier, or a hybrid type humidifier.
It might cause white turbidity outside of the light passing part on the reaction cell.
(22) Analyzer classification and technical specification

Equipment Class :1
Over voltage Category :2
Pollution Degree :2
Power supply voltage : AC100V/115V/220V/230V ±10％
Frequency : 50/60Hz
Power consumption : 1200VA
Ambient temperature : 15∼30℃
Ambient humidity : 40∼80％
(23) WEEE directives

・ Do not throw away this instrument with wastes. This instrument has to be thrown
away as medical waste. Strictly follow laws and regulations of your country when
discarding the instrument
・ When discarding the instrument, please contact our distributer in your country.
・ Please cooperate with recycling to follow a global environment.
・ The trash box mark in the right means the WEEE directives.
0-18
3. Warranty
(1) Warranty period

Twelve months after the installation date or fourteen months from shipment
date from Japan, whichever comes earlier.
(2) Warranty and remedy

- We warrant that, during the warranty period, the analyzer operates in
accordance with our standard technical specifications (failure to operate is
called as “Defect”).
- When a Defect is found and your written claim fully describing the details of
the same is accepted by the end of the warranty period, we will, at our expense
and sole option, provide either of the following
- remedies:
(a) to supply and ship replacement parts on a FCA basis that are
deemed necessary for repair of the analyzer; or
(b) to repair and ship back the analyzer on a FCA basis, when the
analyzer is brought to the designated place at your expense.
- The above warranty and remedy are exclusive and in lieu of any other
warranties and remedies, whether in contract, tort or otherwise.
We will in no event held liable for consequential, incidental or special damages
such as loss of revenue, data and information, even if we have been notified or
aware of the possibility of such damages.
(3) Warranty disclaimer

- We will not be responsible for any defect or nonconformance, including all
losses, costs and damages incidental to them, when any one or more of the
following applies. In this section, the word “analyzer” includes its consumables
and spare parts.
1. Unauthorized removal, displacement or transportation of the analyzer
after installation of the same;
2. Use of the analyzer under improper installation;
3. Unauthorized disassembly, modification or repair of the analyzer;
4. A damage or nonconformance caused by a natural disaster such as
fires, earthquakes and lightning;
5. When the computer used with the analyzer is installed with any
unauthorized program or is connected to any unauthorized
network (including the Internet);
6. Inappropriate storage or maintenance of the analyzer;
7. Incorrect operation of the analyzer;
8. Use of the analyzer under improper operating conditions
(including use under the atmosphere containing corrosive gas)
9. Use of unauthorized consumables or spare parts for the analyzer;
10. Normal wear and tear of the analyzer;
11. Incompatibility of the analyzer with other products
(including that with reagents);
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V5.7
12. A defect or nonconformance that you found or could have found at the
time of receipt of the analyzer such as loss of or apparent damage to the
analyzer and that you failed to promptly notify to us in writing;
13. Minor defect or nonconformance that does not affect operation, function
and performance of the analyzer; and
14. Any other defect or nonconformance that is not attributable to us.
- The warrantees of consumables and spare parts of the analyzer are
to be accordance with its manufacturer's warranty.
- In case any defect or nonconformance is found in the analyzer, both
you and we will, at its own costs respectively, cooperate to
promptly determine the cause of the same, whereby you will, upon
our request, provide us with information in writing that is
necessary to verify such cause.
- If we perform any remedy for a defect or nonconformance of the
analyzer, such as repair and replacement of the analyzer and
payment of compensation money (including offer of price
discount),and subsequently it is found that any one of the events
contained in the foregoing (3) applies and that we are not
responsible for such defect or nonconformance, then you will,
within fourteen days after receipt of our invoice, reimburse us with
all the costs we have incurred associated with the remedy
(including costs associated with the investigation and dispatch of
our personnel) and refund the full amount of the compensation
money we have paid to you. Delay in reimbursement or refund is
subject to the five percent monthly compound overdue interest or
the maximum interest permitted by applicable laws from the due
date till paid in full.
0-20
4. Storage condition and transportation
(1) Store in a room.

(2) Avoid direct sun light.
(3) Store in clean room.
(4) Room temperature should be 1∼45℃.
(5) Room humidity should be 10∼85％RH
(6) No dropping during transportation.
(7) No falling down during transportation.
(8) No shock during transportation.
(9) Transport condition is marked on the box. Follow the written instruction on a label.
(10) Transportation and relocation of the analyzer should be conducted by service
engineers.
5. Environment condition
Analyzer should be operated under the following condition.

(1) Less dust and good ventilation
(2) No direct sun light
(3) Horizontal floor (less than 5mm/m)
(4) Endure weight is over 300kgf/㎡.
(5) Room temperature range is 15∼30℃, and deviation during test is ±2℃.
(6) Humidity range is 40∼80%RH.
(7) No vibration
(8) Electric voltage variation is less than ±10V.
(9) There are no high frequency electro-magnetic emission apparatus nearby.
(10) Power supply switch board with 3rd grade grounding terminal. Resistance is less than
10 .
(11) Volt-ampere should be more than 1500VA.
(12) Don’t put too many plugs in one outlet
(13) Do not install at the position higher than 2000m.
(14) Minimum working space is the followings. (mm)
0-21
V5.7
6. Transport method of the instrument
This instrument is very heavy. If you want to transport the instrument, you have to pack
by exclusive transportation box and transport by forklift. Please be sure to insert a fork to
the following red circle.
＊Our company cannot take responsibility to occur because of packing and transporting by
you.
＊If you want to pack and transport the instrument, please contact our service division.
Four wheels are attached to this instrument. If you push the instrument, you can move
easily. Please use in the case of movement of a short distance.
<Wheels>
And two stoppers are also attached to under the front panel of the instrument. If you use
stopper, you can fix the instrument. Stopper is fixed by turning.
<Stopper>
0-22
7. Cleaning and sterilization
For the cleaning of analyzer, wear rubber globe and wipe by a cloth with neutral detergent
solution.
Do not use organic solvent. To remove biohazard contamination, paper waste by 70%
ethanol solution and paper waste by water thoroughly.
If you use ethanol for sterilization, be careful not to burn. Keep away fire source.
8. Position of the nameplate
The position of the table is as follows.
0-23
Operator’s Manual Table of Contents
Table of Contents
Chapter 1
Outline
Contents
1.1 Specifications................................................................................................................ 1-3

1.2 System structure .......................................................................................................... 1-7
1.2.1 Over all structure .................................................................................................. 1-7
1.2.2 System section diagram ........................................................................................ 1-8
1.2.3 Right side system diagram.................................................................................... 1-9
1.2.4 Left side system diagram...................................................................................1-10
1.2.5 Back side system diagram....................................................................................1-10
1.2.6 Tanks .................................................................................................................... 1-11
1. Pure Water Tank (10L) ............................................................................................ 1-11
2. Reaction Waste Liquid Reservoir （10L) ................................................................ 1-11
1.2.7 Washing Solution Bottle (Alkaline・Acid) ...........................................................1-12
1.2.8 Connection between PC and other device ............................................................1-13
1. Connection diagram .................................................................................................1-13
2. Interface (PC)...........................................................................................................1-13
3. Interface (Tubes) ......................................................................................................1-13
1.2.9 Layout of Electric boards・Thermometers ・Timer .......................................1-14
1.2.10 Personal computer ............................................................................................1-15
T-1
V5.7
Chapter 2
Functions and Principles
Contents
2.1 System overview --------------------------------------------------------------------------- 2-3

2.1.1 System flow chart ---------------------------------------------------------------------- 2-3
2.2 Functions and principles of measurement ------------------------------------------- 2-4
2.2.1 Analysis flow chart -------------------------------------------------------------------- 2-4
2.2.2 Analysis process and optical measurement point ------------------------------ 2-5
1. Analysis process ---------------------------------------------------------------------------- 2-5
2. Optical measurement point ------------------------------------------------------------- 2-5
2.3 Functions and principles of measurement ------------------------------------------- 2-6
2.3.1 Functions of each module ------------------------------------------------------------ 2-6
1. Sampler (STF) ------------------------------------------------------------------------------ 2-6
2. Sampling mechanism (STM and SP) -------------------------------------------------- 2-7
3. Reagent tray (RGT) ----------------------------------------------------------------------- 2-8
4. Washing solution bottles and dilution bottles -------------------------------------- 2-9
5. Reagent probe transfer mechanism (RTM and RP) -------------------------------- 2-10
6. Reaction tray (RCT) ----------------------------------------------------------------------- 2-12
7. Mixing unit（ MU-1, 2） ------------------------------------------------------------------ 2-13
8. Cuvette washing station (CWS) -------------------------------------------------------- 2-14
9. Spectrophotometer------------------------------------------------------------------------- 2-16
10. Printer (option) ----------------------------------------------------------------------- 2-17
2.3.2 ISE module ------------------------------------------------------------------------------ 2-18
1. ISE block diagram ----------------------------------------------------------------------- 2-18
2. Measurement cycle----------------------------------------------------------------------- 2-19
2.3.3 HbA1c Sample preparation ---------------------------------------------------------- 2-21
2.3.4 Sample clot detection ------------------------------------------------------------------ 2-22
2.4 Analysis type -------------------------------------------------------------------------------- 2-23
2.4.1 Kinds of analysis types --------------------------------------------------------------- 2-23
1. One point End assay ---------------------------------------------------------------------- 2-24
2. Two points End assay 1 ------------------------------------------------------------------ 2-25
3. Two points End assay 2 ------------------------------------------------------------------ 2-26
4. One point Rate assay --------------------------------------------------------------------- 2-27
5. Two points Rate assay 1------------------------------------------------------------------ 2-28
6. Two points Rate assay 2------------------------------------------------------------------ 2-29
2.5 Types of calibrations ---------------------------------------------------------------------- 2-30
2.5.1. Linear 1 (Two points Linear) -------------------------------------------------------- 2-31
2.5.2. Linear 2 (Multi-points Linear) ------------------------------------------------------ 2-32
2.5.3. Factor ------------------------------------------------------------------------------------- 2-34
2.5.4 Non-linear -------------------------------------------------------------------------------- 2-35
T-2
1. Logit.log 1 ------------------------------------------------------------------------------------ 2-35

2. Logit.log 2 ------------------------------------------------------------------------------------ 2-36
3. Spline ----------------------------------------------------------------------------------------- 2-37
4. Exponential ---------------------------------------------------------------------------------- 2-38
5. Polynomial ----------------------------------------------------------------------------------- 2-39
2.6 ISE module ---------------------------------------------------------------------------------- 2-40
2.6.1 Calibration ------------------------------------------------------------------------------- 2-40
2.6.2 Concentration calculation ------------------------------------------------------------ 2-40
2.7 Linearity check function ----------------------------------------------------------------- 2-41
2.8 Prozone check function ------------------------------------------------------------------- 2-42
2.9 Serum information (L-H-I) --------------------------------------------------------------- 2-43
2.10 Carryover avoidance ----------------------------------------------------------------------- 2-44
2.10.1 Kinds of carryover avoidances ------------------------------------------------------- 2-44
2.11 Automatic start-up, shut down --------------------------------------------------------- 2-45
2.12 Automatic maintenance ------------------------------------------------------------------ 2-45
T-3
V5.7
Chapter 3
Analysis Operation
Contents
3.1. Software install ............................................................................................................ 3-5

3.1.1 PC specification ..................................................................................................... 3-5
3.1.2 Install Dick ............................................................................................................ 3-5
3.1.3 Installation ............................................................................................................ 3-5
1. Disk1 installation .................................................................................................. 3-5
3. CAUTION .............................................................................................................. 3-6
3.1.4 Version up procedure ............................................................................................. 3-6
3.2. Routine operation ......................................................................................................... 3-7
3.2.1 Start-up inspection ................................................................................................ 3-8
3.2.2 Start-up（Analyzer power switch ON） ............................................................... 3-9
3.2.3 Analyzer initialization .......................................................................................3-11
3.2.4 Item parameter setting ....................................................................................... 3-12
3.2.5 Reagent bottle setting and bottle parameter renewal ....................................... 3-13
1. Reagent bottle setting ......................................................................................... 3-13
2. Residual test number confirmation..................................................................... 3-15
5. Reagent /Measurement stop setting. .................................................................. 3-17
3.2.6 Calibration registration and confirmation ......................................................... 3-18
1. Calibration registration....................................................................................... 3-18
2. Calibration Order ................................................................................................ 3-21
3. Changing procedure of standard sample concentration ..................................... 3-22
3.2.7 Calibration sample measurement ....................................................................... 3-23
3.2.8 Calibration sample measurement results .......................................................... 3-25
3.2.9 Measurement of QC sample ................................................................................ 3-26
1. Operation flow ..................................................................................................... 3-26
2. System parameter setting ................................................................................... 3-26
3. Registration of QC Sample name and Item parameter....................................... 3-27
4. Registration of Quality control parameter .................................................... 3-29
5. QC sample order entry ........................................................................................ 3-30
3.2.10 QC sample measurement ............................................................................... 3-32
3.2.11 Confirmation of the QC sample test results .............................................. 3-33
1. Current QC screen............................................................................................... 3-33
2. Daily graph screen............................................................................................... 3-33
3. Cumulative screen ............................................................................................... 3-34
T-4
3.2.12 Patient sample order entry ..............................................................................3-36

1. Individual test order entry for each sample ........................................................3-36
2. Profile order entry ................................................................................................3-39
3. Group order entry.................................................................................................3-40
4. Deletion of group entry .....................................................................................3-41
3.2.13 Patient sample measurement ...........................................................................3-42
3.2.14 Confirmation of Patient test results .................................................................3-43
3.2.15 Inspection at the end of operation ....................................................................3-44
1. Maintenance washing at the end of the day ........................................................3-45
3.2.16 Shutdown ..........................................................................................................3-47
3.3. Additional operation....................................................................................................3-48
3.3.1 Additional sample measurement .........................................................................3-48
1. Ordering of additional samples ............................................................................3-48
2. Measuring of additional samples .........................................................................3-48
3.3.2 STAT sample measurement.................................................................................3-50
1. Order entry of STAT sample. ...............................................................................3-50
2. STAT sample measurement .................................................................................3-50
3.3.3 Emergency stop ...................................................................................................3-52
3.3.4 Rerun sample measurement .............................................................................3-53
1. Rerun by manual operation .................................................................................3-53
2. Automatic rerun operation ...................................................................................3-57
3.3.5 Carryover avoidance.............................................................................................3-58
1. Related mechanical parts .....................................................................................3-58
2. Cleaning solution bottle setting and bottle parameter registration....................3-58
3. Reagent probe cleaning condition registration ....................................................3-59
4. Reaction cell cleaning condition registration ....................................................3-60
5. Sample probe cleaning condition registration .....................................................3-61
3.3.6 Measurement of serum information ...................................................................3-64
3.3.7 Measurement of HbA1c sample ..........................................................................3-65
1. Item parametor setting ........................................................................................3-65
2. Reagent setting ....................................................................................................3-65
3. Calibration Order .................................................................................................3-65
4. Changing procedure of standard sample concentration ......................................3-66
5. Calibration sample measurement and Calibration sample measurement results.
................................................................................................................................. 66
6. Order entry...........................................................................................................3-67
7. HbA1c measurement ............................................................................................3-68
8. Measurement flow of HbA1c using primary tube. ...............................................3-68
3.4. ISE test condition setting and measurement .......................................................3-69
3.4.1 ISE measurement condition setting.....................................................................3-69
3.4.2 ISE calibration order entry ..................................................................................3-69
3.4.3 ISE standard sample measurement ....................................................................3-70
3.4.4 ISE Calibration results confirmation...................................................................3-72
T-5
V5.7
3.4.5 ISE order entry .................................................................................................... 3-74

3.4.6 ISE measurement and test results confirmation ................................................ 3-74
3.5. Barcode system for samples ....................................................................................... 3-75
3.5.1 Usable blood collecting tubes .............................................................................. 3-75
3.5.2 Readable codes .................................................................................................... 3-75
3.5.3 Readable number of characters and minimum bar width .................................. 3-75
3.5.4 Barcode label position ......................................................................................... 3-76
3.5.5 Setting of blood collecting tubes .......................................................................... 3-76
3.5.6 Sample barcode setting ....................................................................................... 3-77
3.5.7 Explanation and caution for sample ID mode .................................................... 3-78
3.5.8 Method of measuring the specimen ID mode ...................................................... 3-80
3.5.9 Sample ID reading confirmation ......................................................................... 3-80
3.5.10 On-line test results transfer by LAN ............................................................... 3-81
3.6. Simple operation mode ............................................................................................... 3-83
3.6.1 Profile setting for simple operation mode ........................................................... 3-83
3.6.2 Adoption of simple operation mode ..................................................................... 3-85
3.6.3 Operation of simple operation mode ................................................................... 3-86
3.7. Auto start.................................................................................................................... 3-88
3.7.1 Auto start setting ................................................................................................ 3-88
1. Automatic start-up (system power ON, OFF) setting......................................... 3-88
2. Automatic operation setting after start-up (system power ON) ......................... 3-88
3.7.2 Automatic operation and screen display ............................................................. 3-89
1. Automatic start-up timer setting (system power ON, OFF) ............................... 3-89
2. If you do not want to set automatic start-up ...................................................... 3-91
T-6
Chapter 4
Screens and Programming
Contents
4.1 Monitor screen .............................................................................................................. 4-5

4.1.1 Function ................................................................................................................ 4-5
4.1.2 Screen and detailed explanation ........................................................................... 4-6
4.2 Order entry ..................................................................................................................4-10
4.2.1 Function ...............................................................................................................4-10
4.2.2 Screen and its detailed explanation .....................................................................4-10
4.3 Test results screen .......................................................................................................4-19
4.3.1 Function ...............................................................................................................4-19
1. Database ..................................................................................................................4-25
2. Report.......................................................................................................................4-30
4.4 Quality control ............................................................................................................4-32
4.4.1 Function ...............................................................................................................4-32
4.4.2 QC sample name list screen .................................................................................4-33
4.4.3 QC range screen ...................................................................................................4-35
1. Item selection menu screen .....................................................................................4-35
2. QC range setting screen ..........................................................................................4-36
4.4.4 Current QC screen ...............................................................................................4-37
1. Current QC screen ...................................................................................................4-37
4.4.5 Daily screen ..........................................................................................................4-39
1. Daily graph screen ...................................................................................................4-39
4.4.6 Cumulative screen .............................................................................................4-40
1. Cumulative graph screen.........................................................................................4-40
2. Cumulative list screen .............................................................................................4-42
4.5 Reaction monitor .........................................................................................................4-43
4.5.1 Function ...............................................................................................................4-43
1. Optical absorbance list external storage .................................................................4-46
4.6 Item parameters ..........................................................................................................4-47
4.6.1 Function ...............................................................................................................4-47
4.6.2 Common test Item parameter screen...................................................................4-47
1. Item selection menu screen .....................................................................................4-47
4.6.3 Serum information ...............................................................................................4-57
4.6.4 ISE Item parameter screen ..................................................................................4-60
4.6.5 HbA1c parameter screen ......................................................................................4-63
1. HbA1c Item number screen .....................................................................................4-63
2. HbA1c Item number 101 and 102 screen ................................................................4-64
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V5.7
3. HbA1c Item number 106 screen ............................................................................. 4-70

4.6.6 Calculation between Items screen ...................................................................... 4-79
4.6.7 Detergent screen ................................................................................................. 4-82
1. Detergent volume setting, dilution bottle setting ................................................. 4-82
4.7 Reagent parameter screen ......................................................................................... 4-84
4.7.1 Function............................................................................................................... 4-84
4.7.2 Screen and detailed explanation ......................................................................... 4-84
4.8 Calibration screen ................................................................................................... 4-89
4.8.1 Function............................................................................................................... 4-89
4.8.2 Screen and detailed explanation ......................................................................... 4-89
1. Calibration screen ................................................................................................... 4-89
2. Calibration graphics screen .................................................................................... 4-95
4.9 System screen ............................................................................................................. 4-97
4.9.1 Function............................................................................................................... 4-97
4.9.2 System parameter screen .................................................................................... 4-98
4.9.3 Date / Print screen............................................................................................. 4-101
4.9.4 Wash 1 screen .................................................................................................... 4-103
4.9.5 Wash2 screen ..................................................................................................... 4-105
1. Sample Probe Wash (In case of by Item) .............................................................. 4-105
2. Sample Probe Wash (In case of by Specimen) ...................................................... 4-106
3. Sample Probe Wash (In case of by Sample) .......................................................... 4-107
4.9.6 Version information screen ............................................................................... 4-108
4.9.7 Communication setting screen .......................................................................... 4-109
4.9.8 Initial setting screen .......................................................................................... 4-113
4.10 Simple operation screen ............................................................................................4-116
4.10.1 Function.............................................................................................................. 4-116
4.10.2 Screen and detailed explanation ........................................................................ 4-116
4.11 Maintenance screen...................................................................................................4-118
4.11.1 Function.............................................................................................................. 4-118
4.11.3 Maintenance list screen .................................................................................... 4-120
1. Maintenance list ................................................................................................... 4-120
2. Auto stert .............................................................................................................. 4-120
3. Monitor .................................................................................................................. 4-122
4.11.4 File maintenance screen .............................................................................. 4-123
1. ProFile ................................................................................................................... 4-123
2. Sample File ........................................................................................................... 4-124
3. Item File ................................................................................................................ 4-125
4. QC File .................................................................................................................. 4-126
5. Profile for Simple operation .................................................................................. 4-127
4.11.5 Analyzer maintenance screen ........................................................................... 4-128
1. User Maintenance ................................................................................................. 4-128
2. ISE......................................................................................................................... 4-130
T-8
3. Cell Check ..............................................................................................................4-139

4. LAMP .....................................................................................................................4-141
5. Error List Screen ...................................................................................................4-142
6. Result Log ..............................................................................................................4-143
7. Clot Sensor .............................................................................................................4-145
8. Auto-gain ...............................................................................................................4-146
9. Cell Skip.................................................................................................................4-147
4.11.6 Service engineer maintenance screen ..............................................................4-148
4.12 Log Off, Log In screen ...............................................................................................4-149
4.13 Timer setting and date change confirmation screen ................................................4-150
4.13.1 Timer setting ......................................................................................................4-150
4.13.2 Date change confirmation screen .......................................................................4-152
T-9
V5.7
Chapter 5
Maintenance
Contents
5.1 Maintenance preparation ............................................................................................. 5-3

5.1.1 Required tools, goods and parts ............................................................................ 5-3
5.1.2 Maintenance Item list ........................................................................................... 5-4
5.2 Maintenance procedure ................................................................................................ 5-5
5.2.1 Sample probe ......................................................................................................... 5-5
1. Sample Probe Cleaning............................................................................................. 5-5
2. Sample Probe Exchange ........................................................................................... 5-6
5.2.2 Reagent probe ........................................................................................................ 5-8
1. Reagent Probe Cleaning ........................................................................................... 5-8
2. Reagent Probe Exchange.......................................................................................... 5-9
5.2.3 Stirrer .................................................................................................................. 5-12
1. Stirrer cleaning ....................................................................................................... 5-12
5.2.4 Reaction cuvette .................................................................................................. 5-13
1. Cuvette exchange .................................................................................................... 5-13
5.2.5 Separate collection reservoir ............................................................................... 5-15
1. Float switch check................................................................................................... 5-15
5.2.6 Light source ......................................................................................................... 5-16
1. Lamp Exchange ...................................................................................................... 5-16
2. Gain Adjustment ..................................................................................................... 5-19
3. Cell check ................................................................................................................ 5-20
4. Reset of the lamp use time after the lamp exchange ............................................. 5-21
5.2.7 Reagent pump (Inside washing) ......................................................................... 5-22
1. Daily inspection ...................................................................................................... 5-22
2. U-packing replacement ........................................................................................... 5-23
5.2.8 Probe outside washing pump (PWP) ................................................................ 5-25
1. Daily inspection ...................................................................................................... 5-25
2. U-packing replacement ........................................................................................... 5-26
5.2.9 Air removal from the clot sensor ..................................................................... 5-28
1. Preparation ............................................................................................................. 5-28
2. Procedure ................................................................................................................ 5-28
5.2.10 Air trap liquid level check and detergent aspiration method ............................. 5-30
1. Air trap liquid level check....................................................................................... 5-30
2. Air trap detergent aspiration method .................................................................... 5-30
5.2.11 ISE module ......................................................................................................... 5-32
1. Operation on ISE maintenance screen ................................................................... 5-32
2. Exchange of Calibrator 1 (CAL-1) .......................................................................... 5-34
3. Exchange of Calibrator 2 (CAL-2) .......................................................................... 5-35
T-10
4. Exchange of Electrode .............................................................................................5-36

5. Exchange of Pump Tube ..........................................................................................5-37
6. Exchange of PV tube ..............................................................................................5-38
7. Cleaning of ISE sample line (ISE Wash) .................................................................5-39
8. Cleaning of Reagent pot .........................................................................................5-41
9. Removal of bubbles at Ref electrode setting............................................................5-42
10. Storage of electrodes ............................................................................................5-43
5.2.12 Washing of Probe, Cuvette, Stirrer ......................................................................5-44
1. Special wash ............................................................................................................5-44
2. All washing ..............................................................................................................5-44
5.2.13 Washing solution (Alkaline and Acidic) ...............................................................5-45
5.2.14 Waste water handling (Reaction waste liquid reservoir) .................................5-46
5.2.15 Fuse replacement ...............................................................................................5-47
1. Fuse maker and type number..................................................................................5-47
2. Replacement procedure ...........................................................................................5-47
5.3 Saving of Back-up data ...............................................................................................5-48
1. How to save back-up data ........................................................................................5-48
2. Place where Backup data is saved...........................................................................5-49
5.4 Printer (option) ........................................................................................................... 5-50
T-11
V5.7
Chapter 6
Check Flag and Alarm Function
Contents
6.1 Check flag ..................................................................................................................... 6-3

6.1.1 Data message flag .................................................................................................... 6-3
6.1.2 Short sample/reagent check flag .............................................................................. 6-4
6.1.3 Out-of-range frag...................................................................................................... 6-4
6.1.4 Action for a message flag is printed ......................................................................... 6-5
6.2 Warning Dialog Box（Error list） ............................................................................... 6-6
1. Warning Dialog Box .................................................................................................. 6-6
2. Warning Dialog Box details ...................................................................................... 6-7
6.3 Error number and message list .................................................................................... 6-8
6.4 Error causes and solutions ..........................................................................................6-11
6.5 ISE error code list....................................................................................................... 6-18
6.6 ISE error causes and solutions................................................................................... 6-20
6.7 ISE other errors .......................................................................................................... 6-25
Parts List
Periodic Check List
T-12
Operator’s Manual Chapter 1
Chapter 1 Outline
1.1 Specifications .................................................................................................................1-3

1.2 System structure............................................................................................................1-7
1.2.1 Over all structure....................................................................................................1-7
1.2.2 System section diagram ..........................................................................................1-8
1.2.3 Right side system diagram .....................................................................................1-9
1.2.4 Left side system diagram ................................................................................... 1-10
1.2.5 Back side system diagram .................................................................................... 1-10
1.2.6 Tanks .................................................................................................................... 1-11
1. Pure Water Tank (10L) ............................................................................................. 1-11
2. Reaction Waste Liquid Reservoir （10L) ................................................................. 1-11
1.2.7 Washing Solution Bottle (Alkaline・Acid) ............................................................ 1-12
1.2.8 Connection between PC and other device ............................................................. 1-13
1. Connection diagram ................................................................................................. 1-13
2. Interface (PC) ........................................................................................................... 1-13
3. Interface (Tubes)....................................................................................................... 1-13
1.2.9 Layout of Electric boards・Thermometers ・Timer ......................................... 1-14
1.2.10 Personal computer............................................................................................. 1-15
1-1
V5.7
1-2
1.1 Specifications
Item Contents
Discrete, Single line random access, multi-tests
Method
analysis
Test items on board 36 items+ ISE 3 items (Option)
480 tests/hr.
Throughput ・MAX 580tests/hr. (in case of loading ISE)
・160test/hr. (HbA1c Item Only)
End point method, Rate method
Analysis method
ISE
Linear, Factor, Non-linear（ Logit-log, Spline,
Calibration curve
Exponential, Polynomial）
About 8.5 min.
Reaction time
(1st react. about 3.5 min+ 2nd react. about 5 min.)
Tray mode Software tray
Patient sample tray : Tray No. 1 - 900
Tray kind
Calibration tray : No.901,902
Serum, Plasma, Blood cell ,Urine, Dialysate, CSF
Contents of test
(ISE not available for CFS and Blood cell)
Container Sample cup, Primary tube (5mL, 7mL, 10mL)
Patient sample : 1 -72 (Middle, Outside)
Standard sample: 1 -72(Middle, Outside)
Blank sample: 1 -72(Middle, Outside)

(Inside)
Sample
Sampler ISE standard (for urine sample) :2
ISE standard (for dialysis ) :1
QC sample : C1-C30 (Inside)
Emergency sample : E1-E30(Inside)
ISE washing :1
Dispensation
1.0 – 20.0 L (0.1 L steps)
volume
13 types, with pre-dilution
Dilution ratio
3,5,6,10,20,30,40,50,60,70,80,90,100 times
Barcode reader Available
1-3
V5.7
Item Contents
Dispensation R1 ;100-240 μL (1 L steps)

volume R2 ;20 -160 μL (1 L steps)
Number of R1;36position
bottles on board R2;35position
Reagents are cooled at 8 – 12 Celsius degrees.
Reagent (If the room temperature is more than 25 ℃ , the
Storage
maximum cooling will be -13 ℃ from the room
temperature.)
R1;70mL
Bottle volume
R2;30mL
Remain check Liquid surface sensor or countdown
Mixing method By stirrers
Temperature
Direct block heating
control
Reaction
37 plus-minus 0.3Celsius degrees
temperature
Cell skip
Available
function
Reaction
Material：Plastics (Semi-disposable)
tray
Optical path length : 5 mm
Number of cuvette : 90 pieces (15 pieces x 6)
Reaction cuvette
Reaction volume : 100 – 300 micro-liter
Cell Wash: Dilution of stock detergent solutions
(alkaline, acidic) with water in the analyzer
Optical
Cuvette direct measurement
absorption
Fixed 12wavelengths
Wavelengths 340,380,405,450,505,546,570,600,660,700,750,
800nm
Spectropho
tometer Light detector Silicon photo-diode
Wavelength
Plus-minus 2nm
accuracy
Linearity range 0 – 3.0Abs.
Light source 12V 20W Halogen lamp
Operation Personal computer (available for touch panel)
User
Calculation Calculation based on user’s formula
interface
between item Correlation
1-4
Item Contents
Reaction curve monitor
Monitor function
Reagent residual quantity, Run monitor
User Quality control Within a day, Day-to-day variation, Real time QC

interface Data storage
100,000 tests
capacity
Printer (Option)External printer
Instrument→PC：LAN(TCP/IP)
System interface
PC→LIS：LAN（TCP/IP）(HL7 Ver2.5standard)
Equipment Class Class Ⅰ
Over voltage Category Category Ⅱ
Pollution Degree Pollution Degree 2
Power supply AC100V/115V/ 220V/230 V plus-minus 10 % 1200VA
Frequency 50/60 Hz
Electric consumption 1.2kVA
Earth resistance of ground terminal should be less
Grounding
than 10Ω (“Equipment Class I”)
Ambient temperature 15∼ 30℃ (±2℃ during measurement)
Humidity 40∼ 80％ (No condensation)
About 13 L/hour
Water consumption
(Electric conductivity<1micro S/cm)
Rating pressure of the tap
water
（The pressure to the “WATER MAX 0.34Mpa
1” when the water purification
system is set in the outside.）
Dimensions 1050（ W） ×750（ D） ×1145（ H） mm
Instrument： Approx. 290kg
Weights Pure Water Tank： 10kg (When it is filled up)
Reaction Waste Tank： 10kg (When it is filled up)
Pure water tank and Reaction Waste Tank are very heavy.
If you carry those items, Please be careful, especially Reaction Waster Tank is dangerous
by drainage fluid.
When you carry Pure Water Tank and Reaction Waste Tank, Please carry with handle.
Option
Item Contents
Electrodes Na, K, Cl and Reference electrode.

ISE
Probe ISE only
1-5
V5.7
Item Contents
Calibration of
(Default condition)
serum
Automatic calibration is conducted once every 24 hours.
specimen
(Default condition)
Liquid feed
Solution (Calibrator 1) is automatically sent once every 2 hours.
Serum
Plasma 100 L
Sample volume
Dialysis
:Measurement
300 L
Urine
(Use sextuple diluted sample by urine diluent)
Serum
Plasma 45 seconds
Analysis time Dialysis
Urine 60 seconds
Serum (Plasma) Calibrator 2

Reagents Urine Calibrator 1 for urine, Calibrator 2 for urine
Dialysis Dialysis calibrator D
Serum
Sample volume Plasma 100 L
:Calibration Dialysis
ISE Urine 300 L
Na 30.37-73.40
Serum K 29.45-69.46
Cl 21.01-68.71
Slope(mV)
Na 30.37 - 73.44
Urine K 29.46 - 69.46
Cl 21.01 - 68.71
Na 100-200
Serum K 1.0-10.0
Range Cl 70-200
（mmol/L） Na 10-400
Urine K 1.0-200
Cl 30-400
Na CV＜0.5％ (140-160 mmol/L)
Serum K CV＜0.5％ (4.0-6.0 mmol/L)
Cl CV＜0.5％ (100-120 mmol/L)
Reproducibility
Na CV＜2.0％ ( 50-200 mmol/L)
Urine K CV＜2.0％ ( 5-70 mmol/L)
Cl CV＜2.0％ ( 50-200 mmol/L)
1-6
1.2 System structure
The structure of the instrument is shown below:
1.2.1 Over all structure
Top view
System front view
1-7
V5.7
1.2.2 System section diagram
This figure shows a plan of the system when the top cover is removed.
1-8
1.2.3 Right side system diagram
(System power switch)

If you push “|”, switch is ON, and if you push “O”, OFF.
When main power switch is ON, and this switch is
turned ON, analyzer starts up automatically and waits
in stand-by state.
If you turn OFF this switch, all the functions stop,
except cooling functions
(Fuse)
Fuse: time lag, AC250V, 10 A
(Stop button)
If you push this button, all the functions stop.
Note: If the button keeps on, the instrument cannot be

started up. Turn the button in the direction of an
System power switch panel arrow and release the lock.
1-9
V5.7
1.2.4 Left side system diagram
1.2.5 Back side system diagram
(LAN port) To personal computer

RJ-45 connector for the operating terminal
(Printer port)
To Printer (*option) D-SUB 9-pin male
connector for the printer
(Drainage connector)
Main power switch panel
Main power switch panel

〈Main Power Switch (Rear Panel) = Main Breaker〉
If you up the lever, the switch is ON, and if you down the lever, OFF.
If this switch is ON, the reagent cooler is working.
If turn OFF this switch, all the functions stop.
1-10
1.2.6 Tanks
1. Pure Water Tank (10L)
Cable
Float Switch
・Please use ion-exchange water. (Electric conductivity<1 micro S/cm)

・Pure water line filter has to be replaced periodically.
・If residual amount is less than a certain amount , an alarm is given.
2. Reaction Waste Liquid Reservoir （10L)
Reaction Waste
Liquid Reservoir
To water supply and drainage panel
Signal cable
Float switch
・If the content exceeds the set level, an alarm is given.
1-11
V5.7
1.2.7 Washing Solution Bottle (Alkaline・Acid)
・If residual amount is less than a certain amount , an alarm is given.

・Alkaline Washing Solution Bottle (1,000mL)
・Acid Washing Solution Bottle (1,000mL)
Front view
1-12
1.2.8 Connection between PC and other device
The analyzer and the peripheral devices (PC, printer, deionized water container and
waste line) are connected as shown in the following figure. Please ensure the correct
connection.
1. Connection diagram
Purified
water line
PC
Printer (Option) Waste fluid

line
Water
purification
Connection diagram
system
2. Interface (PC)
This is the connection diagram of Interface (Personal computers,
printer)
When you connect the instrument with PC or PC with printer, you have
to use LAN cable.
Personal computer specification, Please refer to Chapter 1 1.2.10
Personal computer.
PC Printer
LAN cable RS232C Straight
LAN port (Option)
3. Interface (Tubes)
Installation of water purification system in the analyzer differs from the
one out of the analyzer. Please refer to Setup manual about the detailed
connection method.
1-13
V5.7
1.2.9 Layout of Electric boards・Thermometers ・Timer
PCB box, thermometers and timer
A B C ② ③ ④ ⑤
The front view when front panel is removed
PCB box
① TCD PCB
② SCU PCB
③ MCU PCB
④ UCN1 PCB
⑤ UCN2 PCB
Thermometers and Timer

A. Timer
Using this timer, the instrument automatically turns system power
supply ON and OFF at the time you have set.
B, C. Temperature controller
This unit controls temperature in the reagent tray at 8 – 12℃ .
1-14
1.2.10 Personal computer
By the personal computer to be used, it depends on the placement of each terminal.

The personal computer instruction manual well we read, should be connected with the
device.
In addition, the handling on the PC alone, please refer to the PC instruction manual
for operations.
To find out actual ports to be used, please refer to the operation manual of your PC.
* Please use the PC that complies with IEC60950.
・PC specification (Recommendation)

Model All in one PC
OS Windows 10 64bit
CPU Intel Core i5/i7
Memory 8GB
Chip set Not specified
Storage 500GB Hard disk
Video chip Not specified
Video ram Not specified
Display resolution WXGA++ (1600x900) above
Display
Multi touch compatible
Speaker Yes
LAN Wired
・LAN cable specification (Recommendation)

Standard CAT5e (Category 5e) above
1-15
Chapter 2
Functions and principles
2.1 System overview ............................................................................................................2-3

2.1.1 System flow chart ...................................................................................................2-3
2.2 Functions and principles of measurement .....................................................................2-4
2.2.1 Analysis flow chart .................................................................................................2-4
2.2.2 Analysis process and optical measurement point ...................................................2-5
1. Analysis process .........................................................................................................2-5
2. Optical measurement point ........................................................................................2-5
2.3 Functions and principles of measurement.....................................................................2-6
2.3.1 Functions of each module .......................................................................................2-6
1. Sampler (STF) ............................................................................................................2-6
2. Sampling mechanism (STM and SP) ..........................................................................2-7
3. Reagent tray (RGT) ....................................................................................................2-8
4. Washing solution bottles and dilution bottles ............................................................2-9
5. Reagent probe transfer mechanism (RTM and RP).................................................. 2-10
6. Reaction tray (RCT).................................................................................................. 2-12
7. Mixing unit（MU-1, 2） ........................................................................................... 2-13
8. Cuvette washing station (CWS) ............................................................................... 2-14
9. Spectrophotometer ................................................................................................... 2-16
10. Printer (option) ................................................................................................... 2-17
2.3.2 ISE module ........................................................................................................... 2-18
1. ISE block diagram .................................................................................................... 2-18
2. Measurement cycle ................................................................................................... 2-19
2.3.3 HbA1c Sample preparation................................................................................... 2-21
2.3.4 Sample clot detection ............................................................................................ 2-22
2.4 Analysis type ............................................................................................................... 2-22
2.4.1 Kinds of analysis types ......................................................................................... 2-23
1. One point End assay................................................................................................. 2-23
2. Two points End assay 1 ............................................................................................ 2-25
3. Two points End assay 2 ............................................................................................ 2-26
4. One point Rate assay................................................................................................ 2-27
5. Two points Rate assay 1 ........................................................................................... 2-28
6. Two points Rate assay 2 ........................................................................................... 2-29
2.5 Types of calibrations ................................................................................................... 2-30
2.5.1 Linear 1 (Two points Linear) ................................................................................ 2-31
2.5.2 Linear 2 (Multi-points Linear).............................................................................. 2-32
2.5.3 Factor ................................................................................................................... 2-34
2.5.4 Non-linear ............................................................................................................. 2-35
1. Logit.log 1 ................................................................................................................. 2-35
2. Logit.log 2 ................................................................................................................. 2-36
3. Spline ....................................................................................................................... 2-37
2-1
V5.7
4. Exponential.............................................................................................................. 2-38
5. Polynomial ............................................................................................................... 2-39
2.6 ISE module .................................................................................................................. 2-40
2.6.1 Calibration ........................................................................................................... 2-40
2.6.2 Concentration calculation .................................................................................... 2-40
2.7 Linearity check function ............................................................................................ 2-41
2.8 Prozone check function................................................................................................ 2-42
2.9 Serum information (L-H-I) .......................................................................................... 2-43
2.10 Carryover avoidance.................................................................................................... 2-44
2.10.1 Kinds of carryover avoidances .............................................................................. 2-44
2.11 Automatic start-up, shut down.................................................................................... 2-45
2.12 Automatic maintenance .............................................................................................. 2-45
2-2
2.1 System overview
2.1.1 System flow chart
Optical measurement flow

Lamp
↓
Reaction cell
↓
Spectrophotometer
↓
A/D converter
↓
Log transformation
↓
Interface
↓
PC
↓
Result
Reaction flow and Unit

Reagent1 dispense R1 prove pump, Prove washing pump
↓
Sample dispense Sample prove pump, Prove washing pump
↓
Mixing 1 Mixing unit
↓
Reagent2 dispense R2 prove pump, Prove washing pump
↓
Mixing 2 Mixing unit
↓
Cuvette washing pump
Cuvette cleaning
(Pure water, Alkaline solution, Acid solution)
↓
Waste liquid Drain pump
2-3
V5.7
2.2 Functions and principles of measurement
2.2.1 Analysis flow chart
START
CUVETTE CLEANING
WATER BLANK 1.5min
EVACUATION
R1 DISPENSATION
7.5sec
SAMPLE DISPENSATION
MIXING
3.5min
1ST Reaction
R2 DISPENSATION 8.5 min
MIXING
5 min
2ND Reaction
END OF MEASUREMENT
CUVETTE CLEANING
2.75 min
AUTO-STOP
2-4
2.2.2 Analysis process and optical measurement point
1. Analysis process
＜Explanation＞
S : Sample dispensation
R1 : R1 dispensation
R2 : R2 dispensation
M : Mixing
2. Optical measurement point

After start
Function Optical measurement point
Water blank measurement 1, 2 ,3

①
② R1 discharge 7
③ Sample dispensation 8
④ Mixing (R1 + sample) 8
⑤ R2 dispensation 36
⑥ Mixing (R2 + reaction solution) 36
⑦ Reaction drainage aspiration 82
* For 1st regent only system, there is not R2 dispensation.
2-5
V5.7
2.3 Functions and principles of measurement
2.3.1 Functions of each module
The functions of main module are explained.

Please refer to “Chapter1.1.2 Structure of the system”.
1. Sampler (STF)
Outside (36 holes)
Intermediate (36 holes)
Inside (30 holes)
1) Function
A sample tray holds cups and tubes.
Sampler rotates a sample tray and transfers samples to the sampling
position.
2) Operation
(Initialization) Rotates clockwise. For patient sample, No. 1 sample
is brought to the sampling position.
(In operation) Rotates clockwise. Transfers samples to the sampling
position one by one.
2-6
2. Sampling mechanism (STM and SP)
Sample probe ISE Sample probe
Probe washing trough Sample pump
Sample probe transfer mechanism (STM) & Sample pump
1) Function
Sample probe aspirates the designated volume of a sample from
position and the sample is dispensed into a reaction cuvette.
The sample probe has a level sensor.
2) Operation
(Initialization) : Sample probe once moves to a reaction cuvette,
then back to the probe washing pot position.
(In operation) : Sample probe moves up and down following (a), (b),
(c) steps. At the washing station, the inside and
outside of probe walls are washed and water
droplets are removed.
(a) Sample cup (b) Cuvette (c) Washing trough
3) Sample dispensation
Sample probe is filled with washing water till tip.
When aspirating sample, the probe aspirates a small amount
of air, and then aspirates a little excess amount of sample,
and dispenses designated volume.
2-7
V5.7
3. Reagent tray (RGT)
Reagent bottle
70ml (R1)
20ml (R2)
Reagent tray Reagent bottle
Reagent aspiration position
1) Function
Reagent tray holds reagent bottles and transfers them to the aspiration
position.
When main power is ON, these bottles are kept cooled.
2) Operation
(Initialization) Rotates clockwise. No.1 reagent bottle is
brought to the reagent aspiration position “A”.
(In operation) Transfers selected reagent bottle to the aspiration
position “A” (1st reagent) or “B” (2nd reagent).
2-8
4. Washing solution bottles and dilution bottles
The bottles for additional washing program are set between the washing
trough and the sample tray.
The position of washing solutions bottles for the sample probe
The bottles for washing solutions and dilution bottles of R1 and R2 are set in
the outside of the reagent tray.
The position of washing The position of The position of washing

solutions and dilution washing solutions solutions bottles for the
bottles for the R1 probe bottles for the R2
sample probe
probe
Bottle position
No.1：Acid solutions
No.2：Alkaline solutions
No.3：Dilutions (Only for R1）
2-9
V5.7
5. Reagent probe transfer mechanism (RTM and RP)
R1 probe R2 probe
Probe washing trough
Reagent probe transfer mechanism (RTM)
R1 pump R2 pump
R1 & R2 Reagent pump
1) Function
Reagent probe aspirates the designated volume of reagent from a reagent
bottle and RTM carries the reagent probe to the cuvette position and the
reagent is dispensed into a reaction cuvette.
Reagent probe has a level sensor.
There are two reagent probes. R1 probe (for the 1st reagent) and R2
probe (for the 2nd reagent) are at the wash positions when
initialized.
R1 and R2 reagent pumps are commonly used for R1 and R2.
When pre-dilution is ordered, the diluent is aspirated from the diluent
bottle and the diluent is dispensed into a cuvette by R1 probe.
2) Operation
(Initialization) Reagent probe stops at the home position of
washing probe side.
(In operation) Reagent probe moves up and down following (a),
(b),(c) steps.
At the washing pot, the inside and outside of probe
walls are washed and water droplets are removed.
(a) Reagent bottle (b) Cuvette (c) Washing trough
2-10
(a) (b) (c)
3) Reagent dispensation
Reagent probe is filled with washing water till tip.
When aspirating reagent, the probe aspirates a small amount of
air, and then aspirates a little excess amount of reagent and
dispenses designated volume.
2-11
V5.7
6. Reaction tray (RCT)
Optical path face
Reaction tray Reaction cuvette
1) Function
Holds reaction cuvettes at 37 Celsius degrees, and lets sample and reagent
react.
Reaction cuvettes are optical cells to measure light absorption.
(Reaction cuvette direct optical measurement)
Reaction cell has become a semi-disposable.
Refer to” Chapter 4, 4.11.6 Analyzer maintenance screen / 3.Cell check”.
The exchange of the reaction cell, see Chapter 5, 5.2.4 Reaction cuvette.
2) Operation
(Initialization): Rotates and stops at the home position.
(In operation) :Rotates to measuring all cuvettes in every cycle.
NOTE
When you remove a reaction cuvette, be careful not to make scratch on
neither inside nor outside wall.
Do not touch the optical face with fingers.
2-12
7. Mixing unit（MU-1, 2）
Mixing unit-1
Mixing unit-2
1) Function
Mixing unit-1 : This unit is used for mixing of 1st reagent and the
sample.
Mixing unit-2 : This unit is used for mixing after adding 2nd
reagent.
2) Operation
Mixing unit-1
(Initialization) : If it is in the down position, it goes up.
(In operation) : Repeats rotation.
Mixing unit-2
(Initialization) : If it is in the down position, it goes up.
(In operation) : Repeats rotation.
2-13
V5.7
8. Cuvette washing station (CWS)
Cuvette washing station Nozzle tip

Cuvette washing mechanism Cuvette washing nozzles
1) Function
The reaction drainage after the test is removed, and the cuvette is washed
with cleaning solution and rinsed with pure water.
And the pure water is dispensed for water blank measurement.
Then the pure water is removed and the cuvette is dried up by a Teflon
sponge.
Washing water is heated to 37 Celsius degrees to get good cleaning efficiency.
2) Operation
(Initialization) If it is in the down position, it goes up.
(In operation) Repeats going up and down.
4) Cuvette washing process
Cuvette washing process
2-14
Position Markers
1 - CWS Reaction liquid Aspiration
Upper ASP Washing liquid aspiration
2
Lower W1 Washing liquid dispense
Upper ALK Alkaline washing liquid aspiration
3
Lower CWSALK Alkaline washing liquid dispense
Upper ACID Acid washing liquid aspiration
4
Lower CWSACID Acid washing liquid dispense
Upper W2 Washing liquid aspiration
5
6
7
8
9 - CWS Washing liquid aspiration
10 - DR2 Residual water droplet removal
11 - DR1 Residual water droplet removal
2-15
V5.7
9. Spectrophotometer
1) General view of optical system
2) Optical measurement feature

White light emitted from the light source lamp is converged to a light
beam, and goes through the reaction cuvette, then leads to a concave
grating, so called the rear diffraction spectrophotometry.
After the diffraction, light energy is measured by 12 individual photo
detectors in each designed wavelength.
For the monochromatic measurement, the output of one detector is taken
out of 12, and for the bi-chromatic measurement, two outputs are taken.
These output voltages are converted into digital data and logarithmic
transformed, which is linearly corresponds with concentration
3) Function
Measures optical absorption of 12 wavelength of pure water and reaction liquid
in cuvettes while the reaction tray rotating.
2-16
10. Printer (option)

Analysis results, and do the printing, such as item parameters.
Printing paper Error lamp
Printer
Paper lamp Feed switch
Control panel
Printer settings, for the connection of the equipment, refer to “Chapter 5,

5.4 Printer”.
2-17
V5.7
2.3.2 ISE module
ISE module is used for measurement of ion concentration (Na+, K+, Cl+) in the
sample. ISE uses a dedicated probe.
Waste1 pump Waste2 pump
Electrode Cal. Pump
1. ISE block diagram
2-18
2. Measurement cycle
(1) Calibration of Serum

① Cal- 1 in the electrode unit is discharged.
② Cal-2 in the electrode unit is moved. The electro-motive force of Cal-2 in the
electrode unit is read.
③ Cal-2 in the electrode unit is discharged.
④ The sample line and the electrode unit are washed with Cal-1.
⑤ At the end of washing, the electro-motive force of Cal-1 in the electrode
unit is read. And the procedure from ①to ⑤ above is repeated once more.
(2)Calibration of urine
①Cal- 1 in the electrode unit is discharged.
②Cal-2 for urine in the electrode unit is moved.
③The electro-motive force of Cal-2 for urine in the electrode unit is read.
④Cal-2 for urine in the electrode unit is discharged.
⑤The sample line and the electrode unit are washed with Cal-1.
⑥At the end of washing, the electro-motive force of Cal-1 in the electrode unit is
read.
⑦Cal- 1 in the electrode unit is discharged.
⑧Cal-1 for urine in the electrode unit is moved and discharged.
⑨Cal-1 for urine in the electrode unit is moved and the electrode unit is read.
⑩Cal- 1 for urine in the electrode unit is discharged.
⑪ The sample line and the electrode unit are washed with Cal-1.
⑫ At the end of washing, the electro-motive force of Cal-1 in the electrode
unit is read.
And the procedure from ①to ⑫ above is repeated once more.

The value of electro-motive force of Cal-1 for urine of 13) in the second cycle is
taken as the result.
(3) Calibration of dialysis

② Cal-D for Dialysis in the electrode unit is moved and electro-motive force of
Cal-D is read.
③ Cal-D for Dialysis in the electrode unit is discharged.
⑤ At the end of washing, the electro-motive force of Cal-1 in the electrode unit
is read.
And the procedure from ① to ⑤ above is repeated once more.
(4) Measurement of serum and dialysis

② Sample is dispensed into the sample line and electro-motive force of sample
is read.
2-19
V5.7
③ Sample in the electrodes unit is discharged.

⑤ The electro-motive force of Cal-1 in the electrode unit is read.
(5)Measurement of urine
Use urine diluted with the urine diluent by six times.

② This diluted urine is drawn to the electrode unit position. And after the
set seconds, it is discharged.
③ This diluted urine is drawn to the electrode unit position.
Electro-motive force of this diluted urine is read.
④ Diluted urine in the electrode unit is discharged.
⑤ The sample line and the electrode unit are washed with Cal-1.
⑥ At the end of washing, the electro-motive force of Cal-1 in the electrode
unit is read.
2-20
2.3.3 HbA1c Sample preparation
HbA1c sample preparation (Hemolysis) is performed automatically.
HbA1c sample preparation flow (Hemolysis)
① Set the centrifugalized tube on the sample tray. (Fig ①)

② Aspirates the red blood cell sample from the blood cell layer by sample
probe.（Fig. ②）
③ Reaction cell 1 (Sample preparation cell)
Dispense the lysing solution and blood cell sample. Prepare the hemolysis
sample by mixing.（Fig. ③）
④ Reaction cell 2
After reagent dispensation to reaction cell 2, aspirate the hemolysis
sample from reaction cell 1 and dispenses.
Continue the measurement. (Fig. ④)
① ② ③ ④
Sample prove Mixing Sample prove
← →
Blood cell
Hemolysis
Tube Reaction cell 1 Reaction cell 2

(Preprocessing)
Centrifugal Aspirates the red Hemolysis the red Aspirates the hemolysis
separate sample blood cell sample blood cell by mixing. sample and dispenses to
and dispenses to cell 2.
hemolysis cell 1.
HbA1c sample preparation flow
2-21
V5.7
2.3.4 Sample clot detection
When the sample probe detects the clot by fibrin, perform the washing
automatically. The error flag “C” is attached to related result.
Solution flow after clot detection
(Sample probe)
Sample aspiration
Clot detection
（Automatic-cleaning ）
Sample probe moves to the
trough and wash 2 times.
【Clot is heavy】
【Dissolve the clot】
Can’t continue the measurement
Restart the measurement from the
next Item. 【Sampling stop】
【End of run】【End of run】
Clean up the sample probe.

Rerun of the clot detected Item.
(Maintenance required)
2.4 Analysis type
2-22
2.4.1 Kinds of analysis types
END RATE
One point end assay One point rate assay
Two points end assay 1 Two points rate assay 1
Measure the optical absorbance at the Concentration or activity is calculated from

fixed time after mixing the reagent and the rate of absorption change.
the sample.
One point end assay One point rate assay
Calculate the absorbance difference of the Calculate the absorbance rate of two
two different intervals, sub- and main- different intervals, sub-interval and main-
intervals. interval, and calculate concentration or
activity from the difference between these
two rates.
Calculate the absorbance rate of two

Calculate the absorbance difference of different intervals, sub-interval and
two different intervals, sub- and main-interval, and calculate concentration
main-intervals. or activity from the difference between these
two rates.
1. One point End assay
Measure the optical absorbance at the fixed time after mixing the reagent
2-23
V5.7
and the sample.
MAIN
ABS
R1 : 1st reagent dispensation
R2 : 2nd reagent dispensation
ABS : Optical absorbance
MAIN :Main-measurement interval
R1+S R2
One point end assay
1) Optical measurement points input

MAIN: 9 ≦ START ≦ END ≦ 76
2) Optical absorbance calculation for unknown sample

Ax :Absorbance of unknown sample
( ∑AＬ１− (R× ∑AＬ２ ))
AL1: Absorbance of main-wavelength
Ax＝ ―――――――――――
AL2: Absorbance of sub-wavelength
N
N : Number of measurement points
R : Bi-chromatic factor (Default= 1)
3) Concentration calculation
Cx : Concentration of unknown sample
(Ax−Ab)
Ax : Absorbance of unknown sample
Cx＝―――――― × Cs
Ab : Absorbance of reagent blank
(As− Ab)
As : Absorbance of standard sample
Cs :Concentration of standard Sample
2-24
2. Two points End assay 1
Calculate the absorbance difference of the two different intervals,

sub- and main-intervals.
MAIN : Main-measurement interval
SUB : Sub-measurement interval
Two points end assay 1

MAIN: 37 ≦ START ≦ END ≦ 76
SUB : 9 ≦ START ≦ END ≦ 32
2) Optical absorbance calculation
( AＬ１−( R× AＬ２ )) ( AＬ１−( R× AＬ２))

Ax＝ ―――――――――― - K × ――――――――――
N MAIN n SUB

AL1 : Absorbance of main-wavelength
AL2 : Absorbance of sub-wavelength
N : Number of measurement points of main-interval
n : Number of measurement points of sub-interval
R : Bi-chromatic factor (default = 1)
K : Volume correction factor (Calculated automatically)
MAIN : Main-interval, SUB: Sub-interval
(Ax − AsL)
Cx＝ ――――――― × (CsH# - CsL#) + CsL#
(AsH − AsL)

Ab : Absorbance of reagent blank sample
AsH : Absorbance of high value standard sample
AsL : Absorbance of low value standard sample
(When standard sample is one, Ab above is used in calculation.)
CsH# : Concentration of high value standard sample
CsL# : Concentration of low value standard sample
2-25
V5.7
3. Two points End assay 2
Calculate the absorbance difference of two different intervals,

sub- and main-intervals.
Two points end assay 2

MAIN: SUB≦ START≦ END≦ 76
SUB: 37≦ START≦ END≦ MAIN
( AＬ１−( R× AＬ２ )) ( AＬ１−( R× AＬ２))

Ax＝ ―――――――――― − K × ――――――――――
N MAIN n SUB
2) Optical absorbance calculation

AL1 : Absorbance of main-wavelength
AL2 : Absorbance of sub-wavelength
N : Number of measurement points of main-interval
n : Number of measurement points of sub-interval
R : Bi-chromatic factor (default = 1)
K : Volume correction factor (Calculated automatically)
MAIN : Main-interval
SUB : Sub-interval
(Ax − AsL)
Cx＝ ――――――― × (CsH# - CsL#) + CsL#
(AsH − AsL)

Ab : Absorbance of reagent blank sample
AsH : Absorbance of high value standard sample
AsL : Absorbance of low value standard sample
(When standard sample is one, Ab above is used in calculation.)
CsH# : Concentration of high value standard sample
CsL# : Concentration of low value standard sample
2-26
4. One point Rate assay
Concentration or activity is calculated from the rate of absorption

change.
MAIN R1 : 1st reagent dispensation
ABS
R1+S R2
One point rate assay

MAIN: 9≦ START< END≦ 76
2) Optical absorbance rate calculation
△Ax＝ (△AL1−△AL2)／ min
△ Ax : Absorbance rate of unknown sample

△ AL1 : Absorbance rate of unknown sample in main-wavelength
△ AL2 : Absorbance rate of unknown sample in sub-wavelength
Absorbance rate is calculated by the least squares method in the

given interval, and the rate is expressed by the absorption change
per minute.
Cx＝ (△Ax−△Ab) × F

Ax : Absorption rate of unknown sample
Ab : Absorption rate of reagent blank
F : Factor
2-27
V5.7
5. Two points Rate assay 1
Calculate the absorbance rate of two different intervals, sub-interval

and main-interval, and calculate concentration or activity from the
difference between these two rates.
SUB S : Sample dispensation

ABS
MAIN R2 : 2nd reagent dispensation
R1+S R2
Two points rate assay 1

Main: 37 ≦ START < END ≦ 76
SUB: 9 ≦ START < END ≦ 32
( AＬ１− AＬ２) ( AＬ１− AＬ２)

Ax＝ ―――――― − K × ――――――
min MAIN min SUB

per minute.
△Ax : Absorbance rate of unknown sample

K : Volume correction factor. (Calculated automatically)
SUB : Sub-interval
Cx＝ (△Ax−△Ab) × F

△ Ax : Absorption rate of unknown sample
△Ab : Absorption rate of reagent blank
F : Factor
2-28
6. Two points Rate assay 2
Calculate the absorbance rate of two different intervals, sub-interval and

main-interval, and calculate concentration or activity from the difference
between these two rates.
SUB MAIN
ABS R1 : 1st reagent dispensation
t
R1+S R2
Two points rate assay 2

MAIN: SUB≦ START < END ≦ 76
SUB: 37 ≦ START < END ≦ MAIN
( AＬ１− AＬ２) ( AＬ１− AＬ２)

Ax＝ ―――――― − K × ――――――
min MAIN min SUB

per minute.
△ Ax : Absorbance rate of unknown sample
K : Volume correction factor. (Calculated automatically)
SUB : Sub-interval
Cx＝ (△Ax−△Ab) × F + Cb

△ Ax : Absorption rate of unknown sample
△Ab : Absorption rate of reagent blank
F : Factor
2-29
V5.7
2.5 Types of calibrations
There are four calibration methods.

1. Linear 1 (Two points linear)
2. Linear 2 (Multi-points linear)
3. Factor
4. Non-linear
4-1 Logit.log 1 4-2 Logit.log 2 4-3 Spline
4-4 Exponential 4-5 Polynomial
1. Linear 1 4-2. Logit.log 2
2. Linear 2 4-3. Spline
3. Factor 4-4．Exponential
4-1. Logit.log 1 4-5．Polynomial

Kinds of calibration
2-30
2.5.1 Linear 1 (Two points Linear)
One standard sample and a blank sample make a linear calibration line.

ABS Conc : Concentration
B : Reagent blank
S Cb : Concentration of reagent blank
As Ax :Absorbance of unknown sample
Ax Cx : Concentration of unknown
B sample
Ab S : Standard sample
Cb Cx Cs As : Absorbance of standard sample
Conc.
Linear 1 Cs :Concentration of standard
sample
1) Standard sample concentration input

Input the standard and blank sample concentration.
2) Concentration calculation of end point assay

(Ax−Ab)
Cx＝ ―――――――× Cs
(As− Ab)
As : Absorbance of standard sample
Cs : Concentration of standard sample
3) Concentration calculation of rate assay

(△Ax−△Ab) △Ax : Absorbance rate of unknown sample
Cx＝ ―――――――× Cs △Ab : Absorbance rate of reagent blank
(△As−△Ab) △As : Absorbance rate of standard sample
Cs : Concentration of standard sample
2-31
V5.7
2.5.2 Linear 2 (Multi-points Linear)
Multiple standard samples (2-6) and a blank sample make a linear

calibration line.
ABS : Absorbance
ABS Conc. : Concentration
Sn
Asn B : Reagent blank
S3 Ab : Absorbance of reagent blank
As3
S2 Cb : Concentration of reagent blank
As2
Ax Ax : Absorbance of unknown sample
As1 S1
Cx : Concentration of unknown
B
Ab sample
Cb Cs1 Cs2 Cs3 Csn S1-Sn : Standard sample
Cx Conc.
As1-Asn: Standard sample absorbance
Linear 2
Cs1-Csn : Standard sample concentration

Input the standard and blank sample concentrations.
Concentration can be input up to 6 Input concentrations from #1 in
increasing order.

As# : Absorbance of standard sample#
Cs# : Concentration of standard sample#
(1) Ax ≦ As1
(Cs1−0)
Cx＝ (Ax− Ab)×―――――――
(As1− Ab)
(2) As1 ≦ Ax ≦ As2
(Cs2−Cs1)
Cx＝ (Ax− As1)×――――――― ＋ Cs1
(As2− As1)
2-32
(3) As2 ≦ Ax ≦ As3
(Cs3−Cs2)
Cx＝ (Ax− As2) ×――――――― ＋ Cs2
(As3− As2)
(4) As3 ≦ Ax ≦ As4
(Cs4−Cs3)
Cx＝ (Ax− As3) ×――――――― ＋ Cs3
(As4− As3)
(5) As4 ≦ Ax ≦ As5
(Cs5−Cs4)
Cx＝ (Ax− As4) ×――――――― ＋ Cs4
(As5− As4)
(6) As5 ≦ Ax ≦ As6
(Cs6−Cs5)
Cx＝ (Ax− As5) ×――――――― ＋ Cs5
(As6− As5)
2-33
V5.7
2.5.3 Factor
A blank sample and a given factor make a linear calibration line.
ABS ABS : Optical absorbance

Conc. : Concentration
B : Reagent blank
Ax Cb : Concentration of reagent blank
B
Ab sample
Cb Cx
Conc.
Factor
1) Factor input
Input the factor into the input frame of Factor dialog box.

Cx＝ (Ax− Ab) × F
F : Factor
3) Concentration calculation of rate assay

Cx＝ (△Ax−△Ab) × F △Ax : Absorbance rate of unknown sample
△Ab : Absorbance rate of reagent blank
F : Factor
4) Factor calculation
Tv 1 1
F ＝ ――― × ――― × ―――――― × 10６
Sv L (ε 1−ε 2)
Tv : Total volume (micro-liter)＝ Sample volume x Dilution ratio＋ Reagent

volume
Sv : Sample volume (micro-liter)
L : Optical length (default ＝ 10 mm)
The measured optical absorption data are converted to 10 mm optical
lengths by system software.
ε1 : Substrate molar light absorption coefficient (1/mol.cm) at main
wavelength.
ε2 : Substrate molar light absorption coefficient (1/mol.cm) at
sub-wavelength.
The calculated factor value or the given factor value from the reagent
maker is used to convert the optical absorption to concentration.
2-34
2.5.4 Non-linear
This logic makes the approximate curve using 2-6 standard samples
including a blank sample, as a calibration curve. There are the following
five types.
The results that exceed the absorbance of the highest concentration
standard with multi-point curve (not including Spline) are considered to
be not reliable.
1. Logit.log 1
This logic is used for the calibration curve in which the absorbance
converges to the increase of concentration.
ABS
Asn Sn ABS :Absorbance
S3
As3 Conc. : Concentration
As2 B : Reagent blank
S2
Ax
As1 S1 Cb :Concentration of reagent blank
Ab Ax : Absorbance of unknown sample
B
Cb Cs1 Cs2 Cs3 Csn sample
Cx Conc. S1-Sn : Standard sample
Logit.log1 A1-An : Absorbance of standard sample
C1-Cn : Concentration of standard sample

At least one standard sample is necessary.
Concentrations can be inputted up to 6.
Input concentrations from #1 in increasing order.
Cx＝ (C＋ Cb) sample
Ax : Absorbance or absorbance
rate of unknown sample
K Cb : Concentration of reagent blank
Ax＝ Ab＋――――――――――― Ab : Absorbance or absorbance rate
(1＋ exp(-a-b×lnC)) of reagent blank
K, a, b : Constants
(Calculated automatically）
1 Ax−Ab
C ＝ exp ―― (ln ――――――― − a)
b K− (Ax− Ab)
2-35
V5.7
2. Logit.log 2
This logic is used for the calibration curve in which the absorbance converges
to the increase of concentration.
As this logic uses more parameters than logit.log 1, better approximation
may be expected.
ABS : Absorbance
ABS
Asn S3 Sn B : Reagent blank
As3 Ab : Absorbance of reagent blank
As2 Cb : Concentration of reagent blank
S2
Ax
As1 S1 Cx : Concentration of unknown
Ab sample
B
S1-Sn : Standard sample
Cb Cs1 Cs2 Cs3 Csn A1-An : Absorbance of standard sample
Cx Conc. C1-Cn : Concentration of standard
Logit.log2 Sample

Input standard and blank sample concentrations.
Concentrations can be input up to 6.
Cx＝ (C＋ Cb) Ax : Absorbance or absorbance rate of
reagent blank
Cb : Concentration of reagent blank
Ab : Absorbance or absorbance rate of
reagent blank
K, a, b, c : Constants
（ Calculated automatically ）
K
Ax＝ Ab＋―――――――――――――
(1＋ exp(-a-b×lnC-c×C))
Calculate C by Newton approximation meth
(Ax−Ab)
0 ＝ a＋ b ×lnC＋ c× C− ln ―――――――――
(K− (Ax− Ab))
2-36
3. Spline
Connect absorption data of #I to #I+1 standard samples (I = 1 - n), taking

into the account of the data of #I-1 and #I+2 and adjust to make a smooth
calibration curve.
ABS : Absorbance
ABS
B : Reagent blank
Asn Ab : Absorbance of reagent blank
As3 Sn
As2 S3 Cb : Concentration of reagent
Ax S2 blank
As1 S1 Ax : Absorbance of unknown
sample
Ab B Cx : Concentration of unknown
Cx Conc. A1-An : Absorbance of standard
sample
Spline sample
C1-Cn : Concentration of standard
sample

At least 2 standard samples are necessary.
C00x : Concentration of unknown sample
Ax : Absorbance or absorbance rate of
Cx＝ (C＋ Cb)
unknown sample
reagent blank
Ax＝ a(I)+b(I)･(C-C(J))+c(I)･(Cx-C(J))２+d(I)･(C-C(J))３
a(I),b(I),c(I),d(I): Constants (Calculated automatically)

I=1∼ N
Calculate C by Newton approximation method
f(C-C(J))=a(I)+b(I)･(C-C(J))+c(I)･(C-C(J))２+d(I)･(C-C(J))３-Ax
Increasing type a(1) ≦ a(N) and a(1) ≧ Ax then C=C1

Decreasing type a(1) ≧ a(N) and a(1) ≦ Ax then C=C1
2-37
V5.7
4. Exponential
For being different from 4-1, 4-2, 4-3 above, this logic is used for the
calibration curve in which the absorbance diverges to the increase of
concentration.
ABS : Absorbance
ABS B : Reagent blank
Asn Ab : Absorbance of reagent
As3 Sn
blank
As2 S3
Ax S2 Cb : Concentration of reagent
As1 blank
S1
Ax : Absorbance of unknown
Ab B sample
Cb Cs1 Cs2 Cs3 Csn sample
Cx Conc.
S1-Sn : Standard sample
Exponential A1-An: Absorbance of standard
sample
C1-Cn: Concentration of standard
sample

sample
Ax : Absorbance or absorbance
Cx ＝ (C＋ Cb)
rate of unknown sample
Cb : Concentration of reagent
blank
Ab : Absorbance or absorbance
rate of reagent blank
K, a, b, c : Constants
(Calculated automatically)
Ax ＝ Ab + K･exp(a･(lnC) + b･(lnC)２ + c･(lnC)３)
Calculate C by Newton approximation method
Ax-Ab
a ･ (lnC)+b･ (lnC)２+c･ (lnC)３ - ln ―――― =0
K
When K ＞ 0 and Ax ≦ Ab, C＝ 0
2-38
5. Polynomial
This calibration curve is used for the case which optical absorbance
decreases as concentration increases.
ABS : Absorbance
ABS
B Conc. : Concentration
Ab S1 B : Reagent blank
As1
S2 Ab : Absorbance of reagent blank
As2
Ax Cb : Concentration of reagent blank
S3 Ax : Absorbance of unknown sample
As3 Sn
Asn Cx :Concentration of unknown sample

Cx Conc. A1-An: Absorbance of standard sample
Polynomial
C1-Cn: Concentration of standard sample

Cx ＝ (C＋ Cb)
Ax : Absorbance or absorbance rate of
unknown sample
reagent blank
K, a, b, c : Constants (Calculated automatically)
C ＝ K +（ a×Ax） + (b×Ax２ ) + (c×Ax３)
2-39
V5.7
2.6 ISE module
ISE (ion selective electrode) measures electro-motive force (mV), induced by ion
concentration in the sample.
Four kinds of electrodes are used for the system.

Na electrode : Sensitive only for Na ion in the sample.
K electrode : Sensitive only for K ion in the sample.
Cl electrode : Sensitive only for Cl ion in the sample.
Reference electrode : No ion selectivity
2.6.1 Calibration
1) Two points calibration

Two points calibration is done every morning, before the system starts to operate.
Calibrator-1(Cal-1) and Calibrator-2 (Cal-2) are measured and the slope, ion
concentration versus mV, is calculated for each item.
When the calculated slope exceeds the slope range, treat referring to “Chapter
6 Check flag ・ Alarm function”. The related electrode of slope error may be a
problem. If all the slopes exceed the slope range, the reference electrode (Ref
electrode) may be problematic.
The slope ranges are shown in “Chapter 1, 1.1 Specifications”.
2) One point calibration

One point calibration is done for every test.
For each test, both sample mV and Calibrator-1(Cal-1) mV are measured.
2.6.2 Concentration calculation

Ca : Concentration of Cal-1
Cx = Ca * 10^ [(Ex – Ea) / S]
Ex : Electromotive force of unknown
sample
Ea : Electromotive force of Cal-1
S : Slope, measured by two points
calibration.
2-40
2.7 Linearity check function
- To determine if a curve is linear, a linearity check will be calculated after

each rate assay.
ＡＢＳ
Ｌ１−Ｌ２
L1 : Main wavelength
L2 : Sub wavelength
△Ａ
△A1 : The slope of measuring
△Ａ１ range 1
△A2 : The slope of measuring
△Ａ２
range 2
△A : The slope of the total curve
Ｔｉｍｅ
Linearity check
1) Parameter setting
Input the numbers in the box of the linearity reference (%)
on Item Parameter screen, and set the check value.
※ The setting of Data Process Main should be more than 3
points.
2) Confirmation of measurement result

When that check exceeds the preset value, “L” flag appears
in the data message on the printout.
3) Calculation Formula
Linearity check ＝ (Δ A1 −Δ A2) / Δ Aｘ 100%
Δ A1 The slope of the first half of the curve

(using a least-squares method.)
Δ A2 The slope of the second half of the curve
ΔA The slope of the range of measuring A
※ They are calculated by using points where Abs. of Main measurement

interval are within the Abs. limit.
However, if the absorbance in the Abs. limit are 1 or 2 points, they are
calculated by using all the points.
※ If the A is lower than 0.006, Linearity check is not conducted.
2-41
V5.7
2.8 Prozone check function
- This function checks if there is a prozone phenomenon in immunoassay.

- Based on the registered parameter, this function checks the curvature
of reaction diagram up to 2 zones, and if prozone is detected, puts the
data message flag “P” on the printout data.
FIRST : Interval (1)
SECOND: Interval (2)
＊ Use main wavelength
Prozone check
1) Prozone check value setting.
Input the Prozone check conditions in Item parameter setting column.
(1) First interval- Start, End : Starting and ending test points of basic
test interval.
Second interval-Start, End: Starting and Ending test points of second
interval.
*Input range is 9 – 76 point.
(2) Limit value: Input the comparison limit value(%).
(3) High, Low: Select the check high or low.
2) No Prozone check condition setting.

Input the no Prozone check condition (minimum Abs. of average,
minimum slope value) in Item parameter Prozone setting column.
(1) Min. Abs. Average :
Enter the minimum absorbance average value of main wavelength in
the first interval. (0~3.0)
(2) Min. Abs. Variation value:
Enter the absorbance variation of main wavelength in the first
interval per cycle. (⊿OD/cycle)（0∼3.0）1 cycle＝7.5sec
In the following cases, Prozone check is not conducted.

※ The set values of the minimum Abs. average and the variation are “0” or
are not set.
※ The Abs. average of the first interval of Main wavelength is lower than
the set value of the minimum Abs. average.
※ The absolute value of the slope of the first interval of Main wavelength is
lower than the set value of the minimum Abs. variation.
3) Calculation formula
Check value (%) = OD2／ OD1＊100
OD1 : The gradient in the first interval
OD2 : The gradient in the second interval
2-42
2.9 Serum information (L-H-I)
The Lipemia, Hemoglobin and bilirubin which included in serum sample is influenced
the result.
The serum information measures the Lipemia, Hemoglobin, Bilirubin (L-H-I), and
judges the level of it.
The serum information result makes the judgement based on the information results.
Affect the measurement result. Lipemia(L)･Hemolysis(H)･Bilirubin(I).
1) Serum information check method

Lipemia (L)
Measures the two wavelengths in the wavelength rang of visible light. (No effect of
hemolysis and bilirubin)
Hemoglobin (Hemolysis・H)
Measures the two wavelengths in the medium wavelength region
(No effect of bilirubin). And measure the two wavelengths in the
long wavelength region.
Bilirubin (Icteric・I)
Measure the two wavelengths in the short wavelength region.
And measure two wavelengths of medium and long-wavelength region.
2) Measurement preparation and method

The serum information Item (L-H-I) is fixed in the program. Prepare the saline bottle
to measure the serum information. (Bottle condition and setting)
＊Order entry and measurement is same as other Items. Please refer to Chapter 3
Operation for details.
Item setting and result Operation
The serum information is set as default.(L-H-I)
Item parameter setting Condition setting of concentration result
transforms to qualitative result.
① The reagent bottle position set in reagent screen
Reagent setting(Position) for Item [L-H-I].
② Set the saline bottle on the reagent tray.
Calibration No necessary
Order entry Order by selection of [L-H-I].
Measurement Use saline as a reagent.
Display value in results column, and judgement of＋−
is shown in qualitative column by the Item parameter
setting.
Result L : Lipemia, H: Hemoglobin, I:Bilirubon
If there is a decision the difference between serum
information by visual, please adjust by changing
the decision value.
2-43
V5.7
2.10 Carryover avoidance
As sample probe, reagent probes and reaction cells contact with different kinds
liquid and sometimes built-in cleaning process is not sufficient.
It may cause carryover. To avoid these kinds of carryover, it is possible to do
special cleaning by carryover protection function.
2.10.1 Kinds of carryover avoidances
1. Reagent probe cleaning

After the aspiration of proceeding reagent, analyzer aspirates cleaning solution
instead of reagent and dispenses into empty cell and washed.
2. Sample probe cleaning

After the aspiration of proceeding sample, sample probe aspirates cleaning
solution instead of sample and dispenses into empty cell.
There are 3 kinds of sample probe cleaning, between Items, samples and
sample kinds. One kind of sample probe washing registration is possible.
3. Reaction cell cleaning

A reaction cell used for registered reagent is not used for test at the next cycle.
Reagent probe dispenses cleaning solution into the cell and washed.
2-44
2.11 Automatic start-up, shut down
By the combination of automatic start-up, shut down and maintenance, shorten the
performance time when start-up and shut down the analyzer.
The settings are available for each day of the week.
Both ON and OFF time should be set. Only ON or OFF time cannot be set.
2.12 Automatic maintenance
This is a function to automatically conduct washing, calibration and etc. when the
analyzer starts up.
Setting both automatic start up and maintenances shortens the time period before
opening for users.
The settings are available for each day of the week.
The time of automatic start up should be set after the system is turned ON.
2-45
Chapter 3 Analysis operation
3.1. Software install ............................................................................................................ 3-5

3.1.1 PC specification ..................................................................................................... 3-5
3.1.2 Install Dick ............................................................................................................ 3-5
3.1.3 Installation ............................................................................................................ 3-5
3. CAUTION .............................................................................................................. 3-6
3.1.4 Version up procedure ............................................................................................. 3-6
3.2. Routine operation ......................................................................................................... 3-7
3.2.1 Start-up inspection ................................................................................................ 3-8
3.2.2 Start-up（Analyzer power switch ON） ............................................................... 3-9
3.2.3 Analyzer initialization ...................................................................................... 3-11
3.2.4 Item parameter setting ........................................................................................3-12
3.2.5 Reagent bottle setting and bottle parameter renewal ........................................3-13
1. Reagent bottle setting ..........................................................................................3-13
2. Residual test number confirmation .....................................................................3-15
5. Reagent /Measurement stop setting. ...................................................................3-17
3.2.6 Calibration registration and confirmation ..........................................................3-18
1. Calibration registration .......................................................................................3-18
2. Calibration Order .................................................................................................3-21
3. Changing procedure of standard sample concentration ......................................3-22
3.2.7 Calibration sample measurement ........................................................................3-23
3.2.8 Calibration sample measurement results ..........................................................3-25
3.2.9 Measurement of QC sample .................................................................................3-26
1. Operation flow ......................................................................................................3-26
2. System parameter setting ....................................................................................3-26
3. Registration of QC Sample name and Item parameter. ......................................3-27
4. Registration of Quality control parameter ....................................................3-29
5. QC sample order entry .........................................................................................3-30
3.2.10 QC sample measurement ................................................................................3-32
3.2.11 Confirmation of the QC sample test results ..............................................3-33
1. Current QC screen ...............................................................................................3-33
2. Daily graph screen ...............................................................................................3-33
3. Cumulative screen................................................................................................3-34
3.2.12 Patient sample order entry ..............................................................................3-36
1. Individual test order entry for each sample ........................................................3-36
2. Profile order entry ................................................................................................3-39
3. Group order entry.................................................................................................3-40
3-1
V5.7
4. Deletion of group entry ..................................................................................... 3-41

3.2.13 Patient sample measurement .......................................................................... 3-42
3.2.14 Confirmation of Patient test results ................................................................ 3-43
3.2.15 Inspection at the end of operation ................................................................... 3-44
1. Maintenance washing at the end of the day ....................................................... 3-45
3.2.16 Shutdown.......................................................................................................... 3-47
3.3. Additional operation ................................................................................................... 3-48
3.3.1 Additional sample measurement ......................................................................... 3-48
1. Ordering of additional samples ........................................................................... 3-48
2. Measuring of additional samples......................................................................... 3-48
3.3.2 STAT sample measurement ................................................................................ 3-50
1. Order entry of STAT sample. ............................................................................... 3-50
2. STAT sample measurement ................................................................................. 3-50
3.3.3 Emergency stop .................................................................................................. 3-52
3.3.4 Rerun sample measurement ............................................................................. 3-53
1. Rerun by manual operation ................................................................................. 3-53
2. Automatic rerun operation .................................................................................. 3-57
3.3.5 Carryover avoidance ............................................................................................ 3-58
1. Related mechanical parts .................................................................................... 3-58
2. Cleaning solution bottle setting and bottle parameter registration ................... 3-58
3. Reagent probe cleaning condition registration.................................................... 3-59
4. Reaction cell cleaning condition registration .................................................... 3-60
5. Sample probe cleaning condition registration ..................................................... 3-61
3.3.6 Measurement of serum information................................................................... 3-64
3.3.7 Measurement of HbA1c sample ......................................................................... 3-65
1. Item parametor setting........................................................................................ 3-65
2. Reagent setting .................................................................................................... 3-65
3. Calibration Order ................................................................................................ 3-65
4. Changing procedure of standard sample concentration...................................... 3-66
5. Calibration sample measurement and Calibration sample measurement results.66
6. Order entry .......................................................................................................... 3-67
7. HbA1c measurement ........................................................................................... 3-68
8. Measurement flow of HbA1c using primary tube. .............................................. 3-68
3.4. ISE test condition setting and measurement....................................................... 3-69
3.4.1 ISE measurement condition setting .................................................................... 3-69
3.4.2 ISE calibration order entry.................................................................................. 3-69
3.4.3 ISE standard sample measurement .................................................................... 3-70
3.4.4 ISE Calibration results confirmation .................................................................. 3-72
3.4.5 ISE order entry .................................................................................................... 3-74
3.4.6 ISE measurement and test results confirmation ................................................ 3-74
3.5. Barcode system for samples ....................................................................................... 3-75
3.5.1 Usable blood collecting tubes............................................................................... 3-75
3.5.2 Readable codes ..................................................................................................... 3-75
3.5.3 Readable number of characters and minimum bar width .................................. 3-75
3-2
3.5.4 Barcode label position ..........................................................................................3-76

3.5.5 Setting of blood collecting tubes ...........................................................................3-76
3.5.6 Sample barcode setting ........................................................................................3-77
3.5.7 Explanation and caution for sample ID mode .....................................................3-78
3.5.8 Method of measuring the specimen ID mode.......................................................3-80
3.5.9 Sample ID reading confirmation..........................................................................3-80
3.5.10 On-line test results transfer by LAN................................................................3-81
3.6. Simple operation mode ................................................................................................3-83
3.6.1 Profile setting for simple operation mode ............................................................3-83
3.6.2 Adoption of simple operation mode ......................................................................3-85
3.6.3 Operation of simple operation mode ....................................................................3-86
3.7. Auto start ....................................................................................................................3-88
3.7.1 Auto start setting .................................................................................................3-88
1. Automatic start-up (system power ON, OFF) setting .........................................3-88
2. Automatic operation setting after start-up (system power ON) ..........................3-88
3.7.2 Automatic operation and screen display ..............................................................3-89
1. Automatic start-up timer setting (system power ON, OFF)................................3-89
2. If you do not want to set automatic start-up .......................................................3-91
3-3
V5.7
3-4
3.1. Software install
3.1.1 PC specification
Refer to Chapter 1, 1.2.10. PC (LAN cable) for PC specification.
3.1.2 Install Dick
There are two CDs (Disk1 & Disk2). Please be sure to install from
Disk1.
Disk 1 : Microsoft SQL Server 2012(2005)Express
Disk 2 : BIOLIS50i program
3.1.3 Installation
Please be sure to install from Disk1.
1. Disk1 installation
1). Insert Disk1 to the PC and installation starts automatically.
2). Select language.
3). Installation starts.
4). Click “Next” button.
5). Click “install” button.
6). Click “Finish” button.
*Disk1 installation is finished. Then install Disk2.
2. Disk2 installation
1). Insert Disk2 to the PC and installation starts automatically.
2). Select language.
3). This screen is shown. Click “Next” button.
4). Please read “Software license agreement” and click “I accept the terms
of the license agreement”.
5). Please input serial number, “User Name” and “Company Name”.
*If the number is “5000290212”, please input like the following photo.
(S/N=50 0029 02 12)
3-5
V5.7
Note: Please input the correct serial number. The analyzer will not work
normally if the wrong number is inputted.
6). Please click “Install” button.

7). Finally please click “Finish” button.
*The icon of Analyzer is shown on your desktop.
(Icon)
BIOLIS 50i
8).Please click the icon and confirm whether the installation is completed
correctly.
Default setting of use authority is User Level 1 (user name [Service], can
use all operations).
3. CAUTION
Disk1
Disk1 Ver. 3.03 is for Win8 and 10 and Disk1 Ver1.00 is for Win7.
Other combinations are not allowed.
Disk2
Disk2 Ver. 1.33 now supports Windows 8 and Windows 10, both 32bit and 64bit
versions OS.
Please refer to following matrix for your better understanding of the
combination of the Disk 1 & 2
32bit 64bit SQL Server
DISK1 V1.00
Windows7 2005 Express
DISK2 V1.33
DISK1 V3.03 DISK1 V3.03
Windows8 2012 Express
DISK2 V1.33 DISK2 V1.33
Windows1 DISK1 V3.03 DISK1 V3.03
2012 Express
0 DISK2 V1.33 DISK2 V1.33
3.1.4 Version up procedure
(1) Uninstall the [BIOLIS 50i].

(2) Install the new version Disk 2.
3-6
3.2. Routine operation
Routine operation (from start up to shutdown) follows the procedure steps.

The operation flow includes unnecessary settings on each time. Please operate
according to the requirement.
Routine operation flow
3.2.1 Start-up inspection
3.2.2 Start-up（ Analyzer power switch ON）
3.2.3 Analyzer initialization （ Ready ）
3.2.4 Measurement condition (Item parameter) setting
3.2.5 Reagent bottle position setting
3.2.6 Calibration setting (Standard sample position, concentration)
3.2.7 Calibration measurement
3.2.8 Calibration result confirmation
3.2.9 QC measurement condition setting (Control setting)
3.2.10 QC sample measurement
3.2.11 QC sample result confirmation
3.2.12 Patient sample order entry
3.2.13 Patient sample measurement
3.2.14 Patient result confirmation
3.2.15 Inspection and maintenance at the end of operation
3.2.16 Shutdown
3-7
V5.7
3.2.1 Start-up inspection
Confirmation of the following points before starting the analyzer. Perform the
reagent refill or other requirement.
1) No obstruction for analyzer movement (Sample probe and Reagent

probes)?
2) Confirmation of water supply.

Is de-ionized water enough in the water reservoir?
Open the water supply line on the water purification system?
3) Confirmation of cleaning solution reservoir.
Are the Alkaline and Acid cleaning solutions enough in the cleaning
solution reservoir?
4) Confirmation of drainage reservoir.
Are the waste tank and separate waste tank empty?
5) Confirmation of residual reagent.
Are the reagents enough?
When analyzer is attached the ISE unit, add the following inspection.
1) Is the ISE Calibrator 1 and Calibration 2 enough?

2) Is the ISE drainage tank empty?
3-8
3.2.2 Start-up（Analyzer power switch ON）
1. Turn ON analyzer main power switch, at rear panel.

If the switch is already ON for reagent cooling, you do not need this step.
2. Turn ON the PC switch.
3. The following login screen is shown automatically.
Login screen
4. Input [User name] and [Password] and click Login button. For User
Name and Password, please refer to the “Chapter4.4.12Logoff, Login s
creen”.
5. After a while, Routine Menu screen appears.
Status monitor Temperature monitor
Status message Routine Menu screen
6. Turn ON system power switch at right side panel of the analyzer.

1). A message [Program Down-Loading] is shown in the center of the
screen and the loading status is also shown
[Program Down-Loading] [Parameter Down-Loading]
2). When loading is completed, this message disappears.

The temperature monitor and the status monitor at the upper
right of the screen change to [WARM-UP] and [IDLE].
3-9
V5.7
IDLE WARM-UP
Routine Menu screen
3). When reaction tray temperature reaches to 37 degrees Celsius,

the voice message, “Temperature has reached to the test temperature”, is
heard and the following dialog box comes up in the center of the
screen.
The temperature monitor at the upper right turns from [WARM-UP]
to [TEMP-OK].
When ISE automatic calibration was failed, the ISE error screen will display
after parameter down loading. Confirm the error details by clicking the
ISE button at down part of monitor screen.
The error message shows by six digit of error code. Refer “Chapter6, 6.5
ISE Error code list”.
Note: The stand-by state means the temperature monitor shows [TEMP-OK].
It will take around 25 minutes after turning ON the system switch.
4). Click Ready button. Perform analyzer initialization.
CAUTION
When analyzer system switch or PC power switch is turned OFF
do not turn them ON within three seconds.
If ISE is built in, do not turn analyzer system switch ON again
within one minute.
3-10
3.2.3 Analyzer initialization
1. Click Ready button.

Some buttons on the screen have function name and also function key
number. This function can exceed by clicking the button on the screen
and also hitting function key on the keyboard.
(ex. Ready= F8 function button)
Click
Routine Menu screen
1) Each analyzer unit moves to the home position, (the starting position)
and stops there.
2) During movement of initialization, the status monitor shows [INIT].
2. If initialization finishes without trouble, the status monitor shows [Ready].
Note: If any trouble occurs during initialization, an error message

appears. Please refer to “Chapter 6 Check flag・ Alarm function”.
Analyzer initialization is possible in [warming up] display.
3-11
V5.7
3.2.4 Item parameter setting
Input Item parameter.

Please refer to “Chapter 4 4.6 Item parameter”.
1. Click Item button.
Click
Routine Menu screen

2. Item screen shown.
Click
Item screen (Optical)
Click Item select button. Item parameter screen shown.

Input measurement condition setting.
Optical ：Optical test items

Serum info ：Serum information
ISE ：ISE (Na, K, Cl)
HbA1c ：HbA1c items
For HbA1c Latex reagent, Item number fixed to 101and 102
For HbA1c Enzymatic reagent. Item number fixed to 106
Calculation ：Calculation items
Detergent ：Washing items
3-12
3.2.5 Reagent bottle setting and bottle parameter renewal
Depending on the combination of system parameters, which is selected in

system parameter screen, display contents of Reagent screen are different.
Please refer to “Chapter 4, 4.9 System screen”
[Reagent remain]: Select Count or Level sensor.

Please refer the drawing below: a part of system parameter screen.
1. Reagent bottle setting
1). Click Reagent button.
Click
Routine Menu screen
2). The following Bottle parameter screen is shown.
Bottle Parameter screen
3-13
V5.7
(3)-1 Registration of new test items

To add a new test item, input a new test item name into the
empty box at the right of position number.
If a box of the right side column of the position number is
empty, you can input a new test item name in this position.
① Move the cursor to the [empty] box above and click.

The color of the box turns from white to blue.
Item list
Back color
Reagent 1: Yellow
Reagent 2: Blue
② Move the cursor to the [Item list] area and click the item you want
to register.
The back color of the item turns from white to blue.
③ Double-click the item.
Item number, item name, reagent structure (R1 or R2) will be
written into the designated position automatically.
④ Click save button.
(3)-2 Deletion of test items

If you need to delete Test Items, follow the following procedure.
① Move the cursor to the [Remain] box of the item to be deleted and click.
The back color of the box changes from white to blue.
② Click Line clear button. Selected item disappears from the screen.
If you want to delete all the test items by one action, click
All Clear button.
③ Click Save button.
④ Reagent bottle setting

The bottle positions of reagent 1 and reagent 2 are matched when
setting the new reagent.
① Click Reagent setting, the tray position No.1 and No. 37 are
matched a side after analyzer is ready.
② Remove the reagent tray cover and set the reagent bottle to the reagent
tray, confirming the position number on the screen.
③ Initialize the analyzer after reagents setting.
3-14
2. Residual test number confirmation
(1) Reagent residual amount information renewal
When [Reagent remain] is [Count] on the system parameter screen

Display [contents]
① Click [T.Counts] to be renewal in the Bottle Parameter screen.
(Clicking Reagent button.)
・ The back color of the box turns from white to blue.
②
② -1 Input the test number of newly prepared reagent into the
box, and press Enter key.
② -2 If you want to input by volume information, set cursor to
the box and input [mL] data, while pressing Ctrl key.
This operation calculates test count from volume data.
② -3 Select a reagent to update. Then Clicking FILL button,
residual test number are renewed automatically.
② -4 When clicking FILLALL button, all reagent are renewed
automatically.
③ Click Save button, save reagent information.
[When [Reagent remain] is [Level sensor %] or [Level sensor Counts] on

the system parameter screen
Reagent display are [%] or [test count].
When I measure the item, a reagent probe checks quantity of
reagent in the reagent bottle and calculates a reagent residual
quantity with quantity of down pulse and updates the reagent
residual quantity.
When check by manual operation,
① Click Reag remain check button at upper right.
② Reagent probe goes to reagent position and downs there to measure
reagent volume in the bottle.
The measured volume is calculated into [%] or [test counts].
※Will not work in the not ready state.
※Update all reagent information.
③ Clicking Save button, save reagent information.

Residual amount information checking is possible in Reagent bottle
parameter screen and Routine Menu screen.
The confirmation of reagent remain is possible when the instrument is
running.
3-15
V5.7
(1) Reagent bottle parameter screen
Clicking Reagent button.

Residual count or volume % or test counts is shown in the table.
Click
Reagent bottle parameter screen
(2) Routine Menu screen
① Clicking Routine Menu button
Click
Routine Menu screen
Click
Reagent info. screen
② Clicking Reagent info button. There is residual amount list.

Residual count or volume % is shown in the table.
Residual volume status is shown by color, yellow shows volume
is under the alarm level, set in residual test volume alarm
setting.
Red shows volume has reached to Test stop setting.
3-16

When residual test number or residual % reaches this [residual test volume
alarm], the back color of [Alarm T. count] box becomes to yellow.
Click
Reagent screen
① Click Reagent button.

② Click [Alarm] box.
③ When System parameter setting is [Count], input [Desired test
number] by keyboard, then press Enter key.
When System parameter setting is [Level sensor], input [Desired
%data] by keyboard, then press Enter key.
④ Save the input information above. Clicking Save button saves
the new information.
5. Reagent /Measurement stop setting.

If residual test number or residual % becomes [Test stop setting], it turns to
red.
System / Configuration screen
3-17
V5.7
3.2.6 Calibration registration and confirmation
For the test items, which need calibration, the registration of

standard sample number (including blank sample) and sampling
repetition number are necessary.
Calibration order entry is possible in this screen.
After the calibration, absorbance data are shown and also the latest
four data are shown as the reference data.
1. Calibration registration
1). Clicking Calibration button.
Click
Routine Menu screen
Following screen appears. Confirm the blank and standard

sample position in calibration screen.
Calibration screen
Tray position- Repetition No.
Latest result Abs.

The upper part of calibration screen
3-18
Note: The sampling of the calibration is to a maximum of three times.
・ The back color of the selected box turns blue.

・ The round of the calibration is 901 or 902.
Note: Default calibration round number is 901.
・ Based on the bottle parameter information, the test items

are written in order of item number automatically.
・ The right side column of [Recalculation] is divided into two
rows: the upper row is for the standard sample number and
the repetition number and the lower row is for the latest
absorbance data.
・ Click ISE Cal result, the calibration results of each
specimen are shown.
・ At the lower part of the screen, the latest four results are
shown in order of new to old.
・ At the lower part of the screen, the latest four results are
shown in order of new to old.
Note: When the item is not on the screen, look for it by clicking or
in the scroll bar on the right side.
2). If additional registration or correction is necessary, follow the procedure

below.
(1) Additional registration of test items

When a test item has added, it is written automatically
according to the bottle parameter information.
① “B1-3” (Blank sample #1 – 3 times test) is written into

[Blank sample number] box of the added test item name
automatically.
If you want to change blank sample or repetition number, click this
box. Back color changes to blue.
Input “Blank sample number and repetition number”, and press
Enter key.
② Click [Standard sample-1] box of the item name to be registered.

Back color changes to blue. Input [Standard sample
number], then press Enter key.
③ Input [Sampling repetition number], then press Enter key.

Screen input Sampling repetition number and changes to sampling
repetition number input screen automatically.
Input [Sampling repetition number], then press Enter key.
The cursor automatically moves to [Standard sample-2] box, at right
3-19
V5.7
side. Back color of the box turns to green.

Repeat 1)-(1) and 1)-(3), when there are more standard samples.
④ Click Save button.

Saving procedure for additional registration and correction.
3). Saving procedure for additional registration and correction.

① Click Save button. The following dialog box appears.
② To save the data, click Yes button. If you do not want to save,
click No button. The dialog box disappears.
Note: If you go to another operation before save operation, the

following dialog box comes out.
・ If you click OK button, screen changes to another screen.

・ If you click Cancel button, screen changes to Calibration
screen, where you can do the save operation
3-20
2. Calibration Order
① Click Calibration button.
Calibration screen
② For Standard sample order entry, click [Order] check box.

When order is accepted, レ mark appears in the [Order] box.
③ For Blank sample order entry, click [Blk Odr.] check box.
When order is accepted, レ mark appears in the box.

Saving procedure for additional registration and correction.
3-21
V5.7
3. Changing procedure of standard sample concentration
The concentration of standard sample procedure is as follows.

Please refer Chapter 4.4.6
① Click Item and select Item parameter which changing the concentration.
② Click calibration conc. box of calibration in Item parameter page 1.
Click Click Item button
Click Item name
Item screen
Calibration standard concentration screen
Note The calibration measurement is necessary after changing the

concentration of standard sample.
3-22
3.2.7 Calibration sample measurement
Measurement sequence setting is possible in System parameter.

By sample : Measure the blank sample for all the items before
measuring each standard sample.
By Item : Measure the blank sample and standard sample in pairs.
1. Click Calibration button.

Set Blank and Standard samples on sample tray, confirming the
sample positions in the screen.
・ Calibration order entry is done in Calibration parameter screen.
Please refer to “Capter3, 3.2.6 Calibration registration and confir
mation”.
Calibration screen
2. Select Round No. in Monitor menu screen. Then click Calib Start
button.
RUN
Click
Routine Menu screen
・ The status monitor display turns from [READY] to [RUN] in

the Routine Menu screen.
Note Select Calibration round [901]. Default round number is set

[901].
3-23
V5.7
3. When the sampling of the last sample has finished, “Sampling has finished
is announced.
The status monitor display turns from [RUN] to [S. STOP].
A letter message: [Sampling has stopped.] flows at the bottom of the
screen.
Note If you want to stop sampling while in operation, click

S.Stop button at the lower left of the screen.
Sampling will stop from the next test item.
Some sampling stop ([S. STOP]), you will not be able to
do is continue to calibration measurements of the same
round as the calibration during the measurement
operation.
After completion of the measurement please go to
([END]).
※ Measurement round selection cannot be clicked
Calib start button and there in the same round.
4. After measurement of all the results and finishing pre-determined operation,

the analyzer stops automatically. Then “Measurement has finished” is an
nounced. The status monitor display turns from [S. STOP] to [END].
※A word [End] flows at the bottom of the screen.
3-24
3.2.8 Calibration sample measurement results
1. Click Calibration button.

・ Test results of calibration sample shown.
Calibration screen
・ As for an average calculation of plural measurements, the most deviated

data is ignored.
・ For example please see the above picture. In case of 3 times measurement,
the data 0.1856 is ignored and then 0.1800 is taken as the test result,
which is an average of 0.1809 and 0.1791.
Note The calibration aspiration is up to 3 times.
2. Click Graph button, and can confirm it displaying the graphics

screen.
3. Registration of reaction monitor data memory capacity can be done

in System parameter screen. 9999 reaction monitor tests capacity is
prepared as default.
If the stored data exceed the capacity, the oldest data will be over-
written and lost. Please refer to “Chapter4, 4.5 Reaction monitor”.
3-25
V5.7
3.2.9 Measurement of QC sample
To perform the QC sample measurement, follow the procedure below.

Profile of pre-accuracy control specimen in quality control screen (control
name, measurement position, such as the setting of the measurement
items) it is possible to be registered, you will be able to simplify the
specimen acceptance of quality control specimen.
1. Operation flow
(1) System parameter setting

(2) Registration of QC sample name
(3) Input of Item parameters
(4) Order entry of QC sample
(5) Measurement of QC sample
(6) Confirmation of the test results
2. System parameter setting
Set the QC sample measurement time in calibration tray.

① Click System button.
The following sub-menus appear in the screen.
② Select Sys. Param button. The following screen appears.

The following default information is shown.
Click
Select measurement timing
System parameter screen

③ [Control method] section
Select the control sample measurement timing.
・[None] means no calibration sample measurement.
・[Last] means Calibration sample measurement comes after Standard
sample measurement.
④ Finishing the selection, click Save button.

The following dialog box appears.
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Save confirmation dialog box
⑤ Click Yes button to save. Click No button not to save.
3. Registration of QC Sample name and Item parameter.
Profile registration for each QC sample is possible in this screen.

Set up a profile for each quality control specimen.
When you set up a profile, specimen received Simply select the
quality control samples by the urging screen, will be automatically
item registration.
① Click QC button. The following buttons appear.

② Clicking Controls button, the following screen appears.
Input QC sample name
QC sample name list screen
③ Input QC sample name, and press Enter key.

④ Input lot number of QC sample into lot number box.
Input lot number of QC sample and press Enter key.
⑤ Input expiration date of QC sample and press Enter key.
⑥ Select sample tray number and position number for control
sample.
⑦ Clicking button, possible tray number and position are shown.
Select proper one tray from the list box.
Up to 6 positions selectable for one Control sample.
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V5.7
⑧ Clicking Item select button lower part of the screen, the

following screen is shown.
Control sample Profile registration screen
⑨ Clicking button of Round box, Item list is shown.

⑩ Select test item to register by clicking. Check mark appears in the
item name box.
⑪ After item selection, clicking Save button to store Profile.
⑫ Clicking Exit button, closes Control sample Profile registration screen.
⑬ Click Save button in Control sample name list screen, to store name list.
If it is not necessary to store, click Delete button.
The following dialog box appears.
Data save confirmation
⑭ Click Yes button to save the data. Click No button not to save the
data.
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4. Registration of Quality control parameter
Input Quality control parameter as follows.
① Click QC Range button.

The following Quality control parameter screen appears.
② Select item from button of Item Name.
Click Click
Select item
Quality control parameter screen
③ Input proper number into input box.

Input a number and hit Enter key.
・ Input Mean 、 SD、 Range.
・ Input magnification enter the SD management range. (1~3)
(If you want ± 2SD, you enter 2 in magnification.)
※ The SD management range for all items is set at the same
magnification. Different magnifications for each item cannot
be set.
・ Low and high value will be automatically calculated.
Input proper values into input box
QC range input screen
④ Click Save button to store.

(Delete all the parameter registration by clicking Delete button)
The following dialog box is shown.
Data save confirmation
⑤ Click Yes button to store the data. Click No button not to store the data.
Dialog box disappears.
⑥ Repeat the procedure ② to ⑤ for the next test item.
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V5.7
5. QC sample order entry
There are two ways of Control sample order entry.

One is profile registration and the other is test item selection.
(5)-1 Order entry by profile registration

To do this operation, Control sample Profile registration is necessary, in
advance. As for Profile registration, please refer to “Chapter 3, 3.2.9-3.
Registration of QC Sample name and Item parameter.”
① Click Order button at lower part of the screen.

② Clicking button of Control row, the following dialog box is shown.
・ Confirm tray and test position.
・ Round S. No., registered in Profile, is shown automatically.
Select control sample name
If this box is selected, it means

control sample is measured at
C position in sample round 1.
The display order is QC sample name and test position.
③ レ Check marks appear at pre-registered test items automatically.

④ Select the test item by clicking the item name.
A check mark will appear in the selection box.
To cancel, click the item name once more.
⑤ Click Save button.
(5)-2 Order entry by test item selection

① Clicking Order button to open Order entry screen.
② Clicking [Sample number box] and input QC sample number.
The QC sample position prepared from C1 to C30.
Input QC sample No.

Select control sample name
Upper left part of Order entry screen
Input sample number and hit Enter key.

Depending on the input sample number, tray number and sample type
are shown automatically.
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③ Confirm Order status is [Order].
④ Input sampling repetition number.

Input [Sampling repetition number] in the # of Aspiration and hit
Enter key.
⑤ Click Control input box and select QC sample name.

Clicking button, registered QC sample name list is shown.
⑥ Select test items by clicking each test item, in Order entry screen.
Name Dil
レＬＤＨ |
レＡＬＢ |
⑦ Click Save button to store the data.

Sample number increases 1. Continue order entry operation.
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V5.7
3.2.10 QC sample measurement
① Entry the QC sample order. Please refer to “Chapter 3, 3.2.9-5 QC sample

order entry”.
② Please set QC sample on the sample tray.
Monitor screen
Click QC Start
button
③ Click QC Start button. The following dialog box is shown.
④ Clicking Yes button, Control sample measurement starts.
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3.2.11 Confirmation of the QC sample test results
QC sample test results are shown as follows.

1. Current QC screen
2. Within day graph
3. Cumulative screen
① Click QC button.
② Clicking Current QC button at the sub menu screen, the following screen
appears.
Current QC screen
③ Identify the Control sample of interest.

Clicking button, at the right end, and select Control sample name.
By selecting a control name, Lot No. and Exp. Date are shown.
④ The latest QC data are shown as above screen. Please refer “Chapter 4,4.4
Current QC screen”
2. Daily graph screen

② Clicking Daily button at the sub menu screen, the following screen appears.
Daily graph screen
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V5.7

Control Name Clicking button at the right end, and select
Control sample name.
Lot No. Clicking button at the right end, and select
Lot. Number.
Date Clicking button at the right end, and select
④ Select all，Measurement results and displays of diurnal variation with the

specified date to date.
3. Cumulative screen
② Clicking Cumulative button at the sub menu screen, the following
screen appears.
Cumulative screen (Graph)

File Date Clicking button at the right end, and select date
range.
Item Name Clicking button at the right end, and select test
item name.
Control Name Clicking button at the right end, and select
Control sample name.
Lot No. By inputting Control Name, Lot No. is shown
automatically.
④ By the input and selection of above information, graphic display of day to

day variation of test results are shown.
・ Upper shows 30 days range.
・ The graph below, the maximum difference is displayed in graph
when you measure the same quality control specimen more
than once per day.
・ The upper side of the upper graph symbol relative to the waist
guards appears.
⑤ Clicking List button in the sub menu, QC test results are shown in list style
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Cumulative screen (List)

Result deletion is possible. When you want to delete a data, click Delete
button.
In the center of the screen, statistic calculation results are shown.
Test count Sample number used for calculation
Mean Mean value of test results
SD Standard deviation
CV% Variation divided by mean value (%)
Min Minimum data
Max Maximum data
Range (Max – Min = Range)
Exp. Date Expiration date of Control sample.
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V5.7
3.2.12 Patient sample order entry
Here explain the case of Sample ID Mode is [by Sample No.].

This analyzer has a sample round modes.
There are three ways for order entry:
a) Order entry of individual test item for each patient sample
b) Profile order entry (pre-set test items group) for each patient sample
c) Group order entry (same items) for a patient sample group
1. Individual test order entry for each sample
① Clicking Order button and Order screen appears.
Click
Routine Menu screen
② Order screen appears.
Order entry screen
③ Ordered test items based on the Bottle parameter information are

shown at the bottom of the screen.
Upper part of order entry screen

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R.Round
The reagent round number and round name are shown.
File Date
The date of built-in clock is automatically shown.
Date selection is possible by clicking button, to refer former order
entry.
Round- S.No.
There are 2 boxes, left box is used for sample round number input and
right box is used for sample number (position number) input.
Input method: number key and Enter key for both boxes.
Acceptable numbers as Round No.: 1 – 900
Acceptable numbers as sample No.: Patient sample 1 – 72
QC sample C1 – C30
STAT sample E1 – E30
Barcode ID
Character string of sample barcode is shown automatically or input if
sample barcode is applied.
Patient ID
Patient ID is shown automatically or input.
If the input patient ID is already registered one, stored information of
the patient are shown automatically.
Name
Input patient name. Insert a space between family name and given name.
Sex
Select one of male, female or unknown from pull down menu.
Date of Birth Input date of birth.
Age
When date of birth is input, age is shown automatically.
If age is less than one, the age is expressed as month and day.
It is possible to input age directly without date of birth input.
Draw Date
Input date and time. Insert a space between date and time.
Doctor
Input the name of doctor in charge.
The doctor name is registered by hitting Enter key.
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V5.7
Section
Input the section in the hospital.
The Section name is registered by hitting Enter key.
Cup
レ Check when the sample cup using with tube as a adopter.
Comment １
Select serum information out of Hemolysis, Lipemia and Bilirubin.
Judge by eyesight and input comment by Clicking list box.
Comment ２ This is the free comment area.
#of Asp
Input the test repetition number and hit Enter key.
Default setting is 1(one), but you can set up to 10.
Specimen
Select one from the list box, Serum, Urine, Plasma, CSF, Dialysis and
Other. Default is serum.
Sampling stats
Character string of sample barcode is shown automatically or input if
sample barcode is applied.
Control
Select one from the list box of registered QC sample name.
By the selection, position number registration and item name registration
are automatically done.
For the QC sample registration, please refer to “Chapter 4, 4.4 QC”.
Sample Status
Automatically shown. There are 6 statuses: entry, under analysis, test
finished, cleared.
Sample Type
Select one from the list box, Patient, Control and STAT. (Standard sample
and STAT sample are shown automatically.) Default is Patient sample.
Order Status Select one of normal or rerun. Default is normal.
Test item selection

Select test items to be measured out of displayed test items.
Name Dil
レＬＤＨ |
レＡＬＢ |
・ Select the test item by clicking the item name.
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A check mark will appear in the selection box.

To cancel, click the item name once more.
・Clicking Order all button, select all test items.
Clicking Clear all button, delete all of the test items.
・ When the sample dilution is necessary, click box of dilution column.
The dilution ratio list will be shown on the right.
Select the dilution ratio out of the list.
・ When modify the ratio or cancel it, click box again and select new one or click
blank space in the list.
・ If you want to modify the ratio or cancel dilution, click box and
select new dilution ratio or click blank space in the list.
13 kinds dilution ratio are prepared: 3, 5, 6, 10, 20, 30, 40, 50, 60,
70, 80, 90, 100.
Test order registration

・ Clicking order button, the above test order is registered.
As the sample number increases automatically, you can continue order
entry for the next sample.
To delete the order on the screen, click Delete button.
Note; Number of calculation items to order, should be less than 10
2. Profile order entry
Before the Profile order registration, it is necessary to do Profile

registration. Please refer to Chapter 4, 4.11.4. File maintenance screen,
Profile explanation.
① Select a Profile by double clicking the Profile name in Profile list box
at the right side of Order entry screen.
Profile List
② The grid lines of selected profile will be blue color from white color.
When selected, レ mark appears at the left of the Profile name.
If you want to cancel the selection, click Profile name or check mark itself.
③ Clicking order button, the above test order is registered.

As the sample number increases automatically, you can continue order
entry for the next sample.
To delete the order on the screen, click Delete button.
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V5.7
3. Group order entry
This function makes it possible to order the same test item or

items for multiple samples by one action.
① Click G. Order button in Order entry screen.

The following dialog box comes out at the center of the screen.
Group order dialog box
② The sample number of the current Order entry screen is automatically

entered as the starting sample number.
No starting sample number modification is possible in this screen.
③ Input the end sample number of the group into the box of End Sample No.,
and hit Enter key in keyboard.
Clicking OK button, the group order is registered.
To cancel group order entry, click Cancel button.
④ Group order entry dialog box disappears.
Note; Be sure that the sample number, which already ordered,

should not be included between the starting sample number
and the end sample number.
If group order sample range includes already ordered sample
number by mistake, over write confirmation screen comes
out at registration stage.
Input number range
Patient sample ; 1 ~ 72
Emergency sample ; E1 ~ E30
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4. Deletion of group entry
It is possible to delete once registered Group order entry.
① Clicking G. Delete button in the Order entry screen, the following

dialog box appears in the center of the screen.
Group delete dialog box
② The sample number of the current Order entry screen is automatically

entered as the starting sample number of the Group deletion.
Note If you want to change the starting sample number of deletion,

please input the proper sample number.
③ Input the end sample number of the group into the input box of
End Sample No. , then hit Enter key.
Clicking OK button, the Group order is deleted.
If you do not want to delete, click Cancel button.
④ The Group delete dialog box disappears.
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V5.7
3.2.13 Patient sample measurement
Patient sample measurement is done using patient sample position.

The patient sample has 72 patient sample positions middle and outside, and 30
control sample positions and 30 STAT sample positions inside are prepared.
Measurement order is reagent set order.
1. Set the samples on the patient sample positions, following to the sample
numbers in the Order entry screen.
Click
Routine Menu screen
2. Select sample round.
3. Click Start button.

The measurement starts.
The status monitor display turns from [READY] to [RUN].
4. When the sampling of the last sample has finished, “Sampling has finished”
is announced, and following dialog box appears on the screen.
The status monitor display turns from [RUN] to [S. STOP].
Note If you want to stop sampling while in operation, click S.Stop

button at the lower left of the screen.
Sampling will stop from the next test item.
When S.Stop button is clicked, following confirmation dialog box
appears in the screen.
To stop sampling, click Yes button, if not click No button.
5. After measurement of all the results and finishing pre-determined operation, the
an analyzer stops automatically.
Then “Measurement has finished” is announced and [END OF RUN] flows
at the bottom of the screen.
The status monitor display turns from [S. STOP] to [END].
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3.2.14 Confirmation of Patient test results
Test result screen and Reaction process monitor are used to confirm test
results. As for Test result screen, please refer to “Chapter 4, 4.3 Test re
sult screen”. As for Reaction process monitor, please refer to “Chapter 4,
4.5 Reaction monitor screen”.
1. Click R&E button. The following screen comes out.

2. Select sample No.
Click R&E button
Rerun order box Data message Short sample

message
R&E Screen
① In case of multiple measurements, the average is stored as the

test result.
② The storage capacity of the Reaction time course data (RC) is 9
999 tests at the maximum. You can change the memory number
in the system parameter screen
③ Input sample number or clicking arrow key, calls a sample
number screen.
Clicking rerun order box at the right of item name of Test r
esults screen, rerun order is entered and check mark appear
s in the box.
As for Rerun order, please refer to “Chapter 3, 3.3.4 Rerun”.
④ Display data message flag in data message column. Display s
hort sample message flag in short sample and reagent check
flag in short message column.
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V5.7
3.2.15 Inspection at the end of operation
At the end of the day, perform the inspection and maintenance of

the following locations.
1. Special Wash (Sample probe, Reagent probe and Mixing stirrer)

Please clean the sample probe, the reagent probe and the
mixing stirrer.
Please refer to “Special Wash” on the next page.
2. ISE
Please discard ISE waste liquid, according to the laws and
local rules. Also please
Clean the reagent pot. Please refer to “Chapter 5, 5.2.10-7 Cle
aning of sample line, and 5.2.10-8 Cleaning of reagent pot”.
3. Sample probe, Reagent probe and Mixing stirrer

Please clean the sample probe, the reagent probe and the
mixing stirrer.
When you clean the analyzer, please put rubber glove
Please refer to the chapter 5, 5.2.1-1.2-1 Probe cleaning, and 5.
2.3 Stirrer cleaning.
4. Sample tray
Please clean the sample tray and wash off remaining samples.
When you clean the analyzer, please put rubber glove
5. Separate collection reservoir

Please discard waste liquid, according to the laws and local rules.
6. Sample Pump and Reagent Pump

Please check there is no water leakage.
7. Cleaning of the analyzer

Please wash out remaining samples and reagents by using
water or neutral detergent.
8. Water line
Please close a water cock
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1. Maintenance washing at the end of the day

Maintenance washing procedures are followings.
Please do “Special Wash” in the last of every day.
(1) Special wash

90 cells are washed in the same procedure as measurement.
Note: Special wash is recommended after measurement once a day.

The detergent needs to be selected according to the type which is
washed.
・ Metallic contamination: Use 30% diluted solution of Acid
detergent 5D.
・ Protein contamination: Use 15% diluted solution of Alkaline
detergent 2.5D.
※ Please refer to the chapter 2, 2.3.1-4 Washing solution bottles

and dilution bottles.
① Firstly, please click READY button.

② Click Mainte button.
Click
Routine Menu screen
③ Click User Mainte button.
Click
④ Click Special wash1 button or click Special wash2 button.

・ Special wash 1 : Set the detergent bottles to the position 1 .
(Acid 30%).
・ Special wash 2 : Set the detergent bottles to the position 2.
(Alkaline 15%)
⑤ The washing start. 90 cells are washed in the same procedure as
measurement automatically. It takes around 26 minutes.
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V5.7
(2) All washing

The washing continues Probe wash Cell wash Mixing stirrer
automatically.
※ Before "All wash , please set " Alkaline detergent diluted for
cleaning probe & cell" at each three places of positions of detergent
bottle position No. 2 of a sample, the first reagent, and the second
reagent.
Please refer to the chapter 2, 2.3.1-4 Washing solution bottles
and dilution bottles.
① Firstly, please click READY button.

② Click Mainte button.
Click
Routine Menu screen
③ Click User Mainte button.
Click
④ Click All wash button.

⑥ The washing start. It takes around 15 minutes.
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3.2.16 Shutdown
Finishing tests of all samples and test items, follow the procedure below to
exit analyzer.
1. Click Exit button.

Clicking “Exit” button is possible from any screen except the instrument is
running or sampling stop.
Note Clicking “Exit” button is impossible when the instrument is

running or sampling stop.
Click
Routine Menu screen
Program exit confirmation dialog box appears in the center of the screen.
Program stop confirmation dialog box
2. Click OK button to exit program. To cancel shutdown, click Cancel button.

3. Clicking Log Off button, input screen for user ID and password is
shown.
Refer to “Chapter 4, 4.12 Log off, Log in screen”.
Under the operation mode, some functions limited depending on the
class of the inputted user ID and password, used in Log-in.
4. Turn OFF the system switch at the right side panel of the analyzer.
・ Even if you have turned OFF the system switch, the reagent cooling
function is still working.
・ If you do not use the analyzer for a certain period of time, turn OFF
the main switch on the rear panel.
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V5.7
3.3. Additional operation
3.3.1 Additional sample measurement
1. Ordering of additional samples

① Please click Order button. Sample order screen appears.
② Please order additional samples
It is possible to order samples during the measurement,
but it is impossible to change the order request during
measurement.
2. Measuring of additional samples

In case of measurements of additional samples after [S.STOP]
① After ordering additional samples, please wait for the sample stop
status.
② When the sampling finishes, there is a voice message “Sampling has
completed.” and then “Sampling Stop” message appears in the lower
screen.
The analyzer status display shows [S. STOP] instead of [RUN].
Message of analyzer status
③ Set the additional samples on the sample tray.
Note; Set additional samples after [S.STOP].
④ Click Start button. The analyzer restarts the measurement.

The additional samples are measured after samples ordered earlier than
them.
・ The analyzer status display shows[RUN].instead of [S. STOP].
・ “Run” message appears in the lower screen.
How to measure additional samples during sampling.

In case the analyzer is during the sampling status, firstly please click
the S.STOP button. Then, the analyzer stops to aspirate the samples.
After that, it is possible to measure additional samples.
(1) Sampling stop

Click S.stop button on Routine Menu screen. The analyzer stops
aspirating samples.
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Click
Routine Menu screen
(2) After ordering of additional samples, please wait for the sampling
stop status.
When the sampling finishes, there is a voice message “Sampling has
screen.
(3) Set the additional samples on the sample tray.
Note; Set additional samples after [S.STOP].
(4) Click Start button. The analyzer restarts the measurement.

The additional samples are measured after samples ordered earlier than
them.
・ The analyzer status display shows[RUN].instead of [S. STOP].
・ “Run” message appears in the lower screen.
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V5.7
3.3.2 STAT sample measurement
Even if analyzer is in operation, Order entry of STAT sample is

possible.
If an operator enters STAT order, a priority is given to STAT
sample measurement.
There are 30 STAT sample positions on the inside of sample unit.
1. Order entry of STAT sample.

As for Order entry procedure, it is the same as patient sample.
When analyzer is under ID mode, sampler goes to designated
position to read barcode label.
Barcode label should be on the sample container.
(1) Click Order button. Order entry screen is shown.
(2) Select STAT sample in [Sample Type] box.
(3) As the sample number, E1 is shown.
If you want to use another number, input a proper number.
(4) Select test items to be measured out of displayed test items.
(5) Register STAT sample test order by clicking Order button.
E1 is input as a default sample number. Click ▼ button.

It is possible to input another sample Select STAT.
number manually.
A part of order entry screen
2. STAT sample measurement

(1) Click STAT button on Routine Menu screen.
Click
Routine Menu screen
Note: No STAT sample order entry while STAT sample is under tests.
No double click Start STAT button.
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(2) The following STAT sample number input screen is shown.
STAT sample number input screen
(3) Input starting sample number into [Start No.] box and stopping
sample number into [Stop No.] box.
If only one sample is registered, input the same number in both input
boxes.
(4) Click Start STAT button in main menu screen. Analyzing starts stat
sample measurement. When the last STAT sample aspiration has finished,
analyzer goes back to normal operation.
In case of no set emergency samples on sample tray

Stop sampling and set emergency samples.
(1) Click S.stop button on Routine Menu screen. The analyzer stops
aspirating samples.
(2) When the sampling finishes, there is a voice message “Sampling has
screen.
The analyzer status display shows [S. STOP] instead of [RUN].
(3) Set the STAT samples on the sample tray.
Note: Set emergency samples after [S.STOP].
(4) Click STAT button on Routine Menu screen. The following STAT
sample number input screen is shown.
(5) Input starting sample number into [Start No.] box and stopping
sample number into [Stop No.] box.
If only one sample is registered, input the same number in both input
boxes.
(6) Click Start STAT button in main menu screen. Analyzing starts stat
sample measurement. When the last STAT sample aspiration has finished,
analyzer goes back to normal operation.
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V5.7
3.3.3 Emergency stop
If you want to stop analyzer immediately after analyzer starting up, follow the
procedure below.
Note: Please note, emergency stop deletes all the information under
measurement, except already measured sample.
If you want to stop sampling, click Sampling Stop button.
(1) Click E. Stop button.
Click
Routine Menu screen
(2) Emergency stop confirmation dialog box appears in the center of the screen.
Emergency stop confirmation dialog box
(3) Click Yes button in the dialog box.

If you click Yes button, all the analysis operation stops.
If you cancel emergency stop, click No button.
(4) When you restart analyzer, analyzer initialization is necessary.

Click Ready button
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3.3.4 Rerun sample measurement
There are two kinds of re-run. One is manual rerun, which is performed
by manual operation after measurement results are given, and the other is
automatic rerun which is performed automatically by setting rerun
condition for each test item before measurement.
1. Rerun by manual operation
The flow of operation

(1) Analyzer initialization.
(2) Confirmation of the residual amount of reagent.
(3) Order entry of rerun samples
(4) Measurement of rerun samples
(5) Confirmation of the test results
(1) Analyzer initialization

① Click Ready button to initialize analyzer.
Note: If rerun operation follows the routine operation directly, initialization

is not necessary.
(2) Confirmation of the residual amount of reagent

① Open the Bottle parameter screen by clicking Reagent button.
② Confirm the residual amount of reagent for the items to rerun.
③ Check the remaining amount of the diluent.
・ Refer “Chapter3, 3.3.5-2”.
Note: When you set newly prepared reagent, it is necessary to do

calibration for the test item.
(3) Rerun order entry

(3)-1 from Order entry screen.
① Click Order button.

② Order entry screen is shown.
Click [Sample number] box, and input sample number for rerun, or
clicking an arrow mark to open Sample number screen for rerun.
Order entry of rerun sample is possible after finishing the test of the item.
Input sample round number and input sample number only.
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V5.7
Input sample round number Input sample No.
Complete
Upper part of Order entry screen
③ Input [Sampling repetition count (1-10)] in [# of Asp] box, and press

Enter key.
④ Select test items for rerun
Name Dil
レＬＤＨ | Dilution ratio box
レＡＬＢ |
To select test item, move the cursor to the box of the item
name and click.
Note: When selected, レ mark appears in the □ .

If clicking the item again, the order is cancelled.
⑤ If the rerun sample needs dilution, click button in [Dil] box.

Dilution ratio list appears.
・ Select the necessary dilution ratio from the list.
・If you change the ratio or cancel dilution, click [Dil] box to show
the list again, and select different ratio. To cancel, click blank
space.
⑥ Click OK button.
⑦ [Sampling status] box change to [Rerun].
Note: Sample number increases one automatically, for the next

sample order entry.
Input the next sample order if you continue rerun.
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(3)-2 Rerun order entry from test results screen
① Click R&E button on the lower part of screen.

② The following Review and edit screen appears.
Click [Sample number] box and input sample number for rerun, or
clicking an arrow mark to open Sample number screen for rerun.
Order entry of rerun sample is possible after finishing the test of the
item. Input round number and sample number.
Input sample round number. Input sample No.
Upper part of Order entry screen
③ Select test items for rerun.

Clicking [Rerun order box] at the side of test item name, register rerun
order. レ Clicking again, cancel the order.
Rerun order entry box
R&E screen
④ If the rerun sample needs dilution, click button in [Dil] box.

・ Dilution ratio list appears. Select the necessary dilution ratio from
the list.
・ If you change the ratio or cancel dilution, click button in [Dil]
box to show the list again, and select different ratio.
To cancel, click blank space.
⑤ Click Order button.

・ [Sampling status] box change to [Rerun].
・ When selected, レ mark appears in the □ . If clicking the item
again, the order is cancelled.
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V5.7
(4) Rerun sample measurement

Operation for rerun is the same as patient sample operation.
Click Start button.
・ Measurement starts.
・The status monitor display turns from [READY] to [RUN].
(5) Confirmation of the rerun test results

Operation is the same as the patient sample operation.
① Click R&E button.

Input sample round number
Input sample No.
Former result
Rerun order box

Rerun test result
R&E screen
② R&E screen appears.

The former results are shown at left side and rerun results are sh
own at the right.
Input [Sample number] and hit Enter key or clicking Arrow
button to open Sample number screen to confirm. Under another s
ample round, input sample round number and sample number.
The former results are shown at left side and rerun results are sh
own at the right.
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2. Automatic rerun operation
To do automatic rerun, it is necessary to set parameters in advance.

As for dilution bottle setting, refer Chapter3, 3.5-2.
No special operation is necessary to run automatic rerun.
The test results confirmation is the same operation as manual rerun.
If automated testing has been set, please do not remove or replace
the sample during the measurement.
2-1 Rerun parameter setting screen

Two screens are used to input parameters.
(1) System・ System Parameter screen
(2) page 4 of Item parameter screen
2-2 System parameter setting

① Clicking System button, the following screen is shown.
Click
Click
Click
System Parameter screen
② Clicking Sys.Param button.

③ Clicking ON in the [Auto rerun].
④ Set automatic re-run by clicking Save button.
2-3 Item parameter setting

Set the condition for auto re-run for each test item.
① Clicking Item button, the following Item parameter screen
is shown.
② Clicking button in item number box, item list is shown.
③ Select an item to rerun by clicking it, page 1 of Item parameter screen is
shown. Clicking Next Page 3 times, page 4 is shown.
④ Set the condition for each.
④-1 Select ON by clicking in [Auto-rerun SW].
④-2 Set conditions for the auto-rerun operation.
Refer “Chapter 4, 4.6.2 Item parameter screen”, for the details
of condition registration.
⑤ Click Save button to register the setting.
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3.3.5 Carryover avoidance
As sample probe, reagent probes and reaction cells contact with different
kinds of liquid and sometimes built-in cleaning process is not sufficient.
It may cause carryover.
To avoid these kinds of carryover, it is possible to do special cleaning by
carryover protection function.
To use this function, it is necessary to know when carryover may happen
by Exp.
1. Related mechanical parts

(1) Reagent probes (only from R1 to R1 or from R2 to R2)
(2) Reaction cell
(3) Sample probe
2. Cleaning solution bottle setting and bottle parameter registration

(1) Cleaning solution parameter registration
・ Register cleaning solution as one of reagent. Cleaning solutions are
registered as default.
・ As for modification of above registration or new registration, refer
to “Chapter 4, 4.6.7 Detergent screen”.
(2) Cleaning solution bottle setting

・ Cleaning solution bottles are set in a detergent bottle area.
【Detergent bottle position】
No.1：Acid DetergentNo.2：Alkaline detergent （No.3：Dilution-R1position）
R1 probe detergent R2 probe detergent Sample probe detergent
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3. Reagent probe cleaning condition registration
After the aspiration of proceeding reagent, analyzer aspirates registered

cleaning solution and dispenses into empty cell. (No sample dispensing) As
the result, lose one test cycle. Register test items which may cause carryover
(Item 1), accessible item (Item 2) and cleaning solution to use.
As for probe cleaning condition, following 3 conditions are possible.

1. If register item 1 only, cleaning is done after the test, using item 1.
2. If register item 2 only, cleaning is done before the test, using item 2
3. If register both item 1 and item 2, cleaning is done between the
tests when this combination occurs.
Registration of reagent probe cleaning condition

② Clicking Wash 1 button in sub-menu, Reagent probe wash and cell
wash screen appears.
Select Item 1 Select Item 2 Select Detergent
Reagent probe wash and cell wash screen
③ Register reagent probe cleaning condition.

Select the item and detergent by clicking button at the right.
Item 1: Select the item, which may cause carryover, as a preceding
reagent.
Item 2: Select the item, which may cause carryover, as a following
reagent.
Detergent: Select the detergent.
④ Clicking Save button, following dialog box is shown.
⑤ Click Yes button to store the data. Dialog box disappears.

Click No button not to store the data.
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4. Reaction cell cleaning condition registration
A reaction cell used for registered reagent is not used for test at
the next cycle. Reagent probe dispenses cleaning solution into the
cell and washed.
Register test items which may cause carryover (Item） and cleaning
solution to use.
Registration of reaction cell cleaning condition

② Clicking Wash 1 button in the sub-menu, Reagent probe wash and cell wash
screen appears.
Select item Select detergent
Reagent probe wash and cell wash screen
③ Register the reaction cell cleaning condition.

Item: Select the item, which may cause carryover, as a preceding
reagent.
Detergent: Select cleaning solution from the item list.
④ Clicking Save button, following dialog box is shown.
⑤ Click Yes button to store the data. Dialog box disappears.

Click No button not to store the data.
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5. Sample probe cleaning condition registration
After the aspiration of proceeding sample, sample probe aspirates registered

cleaning solution and dispenses into empty cell. As the result, lose one test cycle.
There are 3 kinds of sample probe cleaning: Between items, between samples
and between sample kinds.
One kind of sample probe washing registration is possible.
[Cleaning pattern selection]

② Click Sys.Param. button in the sub menu.
Select one pattern from [Sample Probe Wash] box: [by Item], [by sample]
or [by Speciman].
※Depending on the selected cleaning pattern, different screen is shown.
In case of [by Item]

[Cleaning condition registrations]
② Clicking Wash 2 button in the sub menu, the following screen
appears.
Sample Probe Wash （by Item）screen
③ Registration of sample probe washing condition.

Item 1: Select the item, which may cause carryover, as a preceding
reagent.
Item 2: Select the item, which may cause carryover, as a following
reagent.
④ Clicking Save button. Following dialog box is shown.
⑤ To register the condition, click Yes button. Dialog box disappears.

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In case of [by Sample]

① Click Order button. Sample Probe Wash button is shown in Order entry
screen.
Click Sample Probe Wash.

*Only when sample probe wash is set,
this button appears.
Order entry screen (by sample)
② Clicking Sample probe wash button, following screen is shown.
Washing selection screen
□Valid If checked, does cleaning.

Timing
Before sampling Cleaning is done before sampling
After sampling Cleaning is done after sampling
Before and After Cleaning is done before and after sampling
Wash bottle position
Acid Use cleaning solution located at position
Acid detergent.
Alkaline Use cleaning solution located at position
Alkaline detergent.
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In case of [by Specimen ]

② Clicking Wash 2 button in the sub menu, the following screen
appears.
Sample Probe Wash（by Specimen）screen

Select the item by clicking button at the right.
Item 1: Select the item, which may cause carryover, as a
preceding reagent.
Item 2: Select the item, which may cause carryover, as a
following reagent.
④ Clicking Save button. Following dialog box is shown.
⑤ To register the condition, click Yes button to save.

Dialog box disappears.
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3.3.6 Measurement of serum information
The measurement of serum information is necessary reagent bottle setting after

item parameter input. The Calibration measurement is not necessary.
1. Setting of serum information

Please open the item screen and click the serum information button.
Please refer to “Chapter 4.6.3 Serum Information”.
You can change the following setting only; Page. 1 Item name, Reagent Bottle
volume Page. 2 Qualitative value
In case the results are considered incorrect by visual determination and,
please change the Qualitative values and adjust the results.
2. Setting of the reagent bottle

Please click Reagent bottle and set the reagent bottle for serum information
in the reagent bottle setting screen.
Set the saline bottle at reagent position for measurement of serum
information
Please refer to “Chapter 3,.2.5-1 Reagent bottle setting”.
3. Order serum information in Order screen. (Default Item name is L-H-I).

The measurement operation is identical with common item test.
Serum information Item
Order serum information in Order screen.
4. The result indication is selected concentration or qualitative value. For

further detail of item L, H and I, please refer to “Chapter 4.6.3 Serum
Information”.
Result printout
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3.3.7 Measurement of HbA1c sample
1. Item parametor setting
Parameters for measurement of HbA1c are set on Item screen.

Setting screen depends on the type of reagent.
・Item number 101, 102 = Latex method
・Item number 106 = Enzymatic method
Refer to Chapter 4.4.6 about the detailed item parameters.
2. Reagent setting
Set the lysing and HbA1c reagents.

・ No.99 of lysing is used for HbA1c lysing solution.
・ The reagent 1 and 2 are set same as common Item.
Lysing
Reagent 1
Reagent 2
Reagent screen
3. Calibration Order
Ordering calibration for item number 106 (enzymatic method) differs

from others.
(1) Click Calibration button.
Calibration screen
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(2) Calibration order

① For Standard sample order entry, click [Order] check box.
When order is accepted, レ mark appears in the [Order] box.
② For Blank sample order entry, click [Blk Odr.] check box.
When order is accepted, レ mark appears in the box.
(3) Click Save button. Saving procedure for additional registration
Note: Calibration order for HbA1c of Item 106.

The Item “106 HbA1c” is not display in calibration screen. It
separates to “107 Hb” and “108 A1c” automatically.
The HbA1c calibration measurement performs Hb and A1c Items
by ordering “107 Hb” and “108 A1c”. The Item numbers of 106
HbA1c, 107 Hb and 108 A1c are fixed.
Calibration screen
4. Changing procedure of standard sample concentration
The Changing procedure of standard sample concentration is identical

with common item test. Please refer Chapter3, 3.2.6-3 Changing
procedure of standard sample concentration.
5. Calibration sample measurement and Calibration sample

measurement results.
The Calibration sample measurement is identical with common item

test. Please refer Chapter3, 3.2.7 Calibration sample measurement, and
Chapter3, 3.2.8 Calibration sample measurement results.
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6. Order entry
(1) Clicking Order button and Order screen appears.

(2) Select specimen from the list, HbA1c(Whole blood) or HbA1c
(Primary tube).
HbA1c
Order screen
Note: Selecting “Whole blood”, and “hemolyzed” the sampling follows

level sensor same as serum sample.
Selecting “Primary tube”, the sampling is used the height in
Item parameter setting.
(3) The HbA1c item names appear.

Select the test item by clicking the item name.
HbA1c Items
Order screen
(4) Clicking Order button, the above test order is registered.
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7. HbA1c measurement
(1) Set the HbA1c sample on the patient sample position.
HbA1c primary tube
(2) Click Start button. Analyzing starts measurement.

(3) After measurement of all the results, the an analyzer stops
automatically.
8. Measurement flow of HbA1c using primary tube.
(1) Dispense lysing solution to the reaction cell from lysing bottle.
(2) Sampling from layer of red blood cell when set the primary
tube.
(3) Wash outside the sample probe using washing water by up and
down movement in trough position.
(4) Dispense red blood cell after aspiration of washing water, lyse
with mixing.
(5) HbA1c reagent 1 dispenses next reaction cell of lysing cell.
(6) Wash tip of sample probe, aspirate the lysing sample and
dispense reagent 1 reaction cell.
(7) Dispense reagent 2 to continue reaction, measure fixing time
under Item parameter setting.
※ The Hb measuring is in first reaction and A1c is measured in

second reaction when using enzymatic reagent of HbA1c.
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3.4. ISE test condition setting and measurement
3.4.1 ISE measurement condition setting
Registration is done in System parameter screen.
ISE
① Clicking System button, and Clicking Sys. Param. button.

The following System parameter screen is shown.
② Clicking ISE in [System] area of the screen, an レ mark appears in the
input box.
3.4.2 ISE calibration order entry
ISE module automatically do calibration for serum sample every 24 hours by using
Cal 1 and Cal 2.
Manual calibration, please refer to the normal calibration of “Chapter4, 4.11.5.
Analyzer maintenance screen-2 ISE-4.Calibration”.
1. How to do ISE calibration order entry for urine and dialysis sample
Note ISE calibration for urine dialysis sample

After confirming no error about serum calibration results, conduct dialysis
calibration.
Refer to Chapter3, 3.4.4 ISE Calibration results confirmation.
If error occurs, eliminate the error referring to “Chapter6, 6.3 Error Number
and Message list, 6.4 ISE Error Code list”.
Refer to “Chapter4, 4.11.5.Analyzer maintenance screen-2 ISE-4.Calibration”.
① Clicking Calibration button, following calibration order screen comes out.

② Clicking S.Rnd. button, select No.901 or No.902.
③ As order entry, select sample kind by clicking, in [ISE-Calibration] area.
Multiple kinds selection is possible.
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V5.7
Check
Click
Calibration screen
Note: If you select urine and dialysis, position numbers of calibration tray are
assigned as followings: CE29 is dialysis standard sample, CE27 is urine
standard sample 1 and CE28 is urine standard sample 2
3.4.3 ISE standard sample measurement
ISE module automatically do calibration for serum sample every 24 hours by using
Cal 1 and Cal 2.
Manual calibration, please refer to the normal calibration of “Chapter4, 4.11.5
Analyzer maintenance screen-2 ISE-4.Calibration”.
ISE calibration for urine and dialysis is done using sample tray.
① To initialize analyzer, click Ready button.
② Set sample cups containing standard samples for necessary ISE sample kinds.
Serum ;Use CAL-1 and CAL-2 packs
Urine ;Set a cup with Urine CAL-1 500 micro-litter at C27 position, and set a
cup with Urine CAL-2 500 micro-litter at C28 position.
Dialysis ;Set a cup with CAL-D 400 micro-litterＣ29 position.
Pour each calibration liquid.
For Urine, set CAL-1 to C27.
For Urine, set CAL-2 to C28

Sample cup
For Dialysis, set to C 29.
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③ Click Calib Start button to start calibration tests.
Click
Routine Menu screen
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V5.7
3.4.4 ISE Calibration results confirmation
ISE calibration results of will be displayed in two ways screen.
1. Routine menu screen / ISE button

(1) Click ISE button.
Click
Routine Menu screen
2) Click Calb.result button.
Click
ISE maintenance screen
3) ISE calibration results are shown.
Calb.result screen
Note: If ISE unit was in operation, the error will pop up display.
If an error has occurred during the calibration measurement, Error
code is displayed in the normal calibration results confirmation
screen.
Refer to "Chapter 6, 6.3 Error Number and message list, 6.5 ISE
Error code list".
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2. Calibration screen
(1) Clicking ISECalresult, serum ISE calibration results are shown.
Click
Calibration screen
Serum
Urine ISE Calibration result
Dialysis ISE calibration result
Note: If ISE unit was in operation, the error will pop up display.
If an error has occurred during the calibration measurement, Error
code is displayed in the normal calibration results confirmation
screen.
Refer to "Chapter 6, 6.3 Error Number and message list, 6.5 ISE
Error code list".
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V5.7
3.4.5 ISE order entry
ISE order entry is performed in Order entry screen like other order entries.
Note Multiple measurements for electrolyte are not available.

If you order multiple measurements in Order screen, the measurement is only
once.
ISE Na,K,Cl
Order entry screen
① When setting electrolyte ON in System parameter screen, Na, K, Cl is lit up

and ISE order entry become possible.
② Click Na, K, Cl button for order entry.
3.4.6 ISE measurement and test results confirmation
ISE test is performed together with the measurement of other items.

Please refer to Chapter3, 3.2.14Confirmation of Patient test results.
If any error occurred, popup display shown and an error code of 6 digits is
printed in data message area.
Refer to “Chapter 6, 6.5 ISE error code list”. In some cases, the error code
is out multiple at the same time. Numerical value is placed in the 1-6-digit
multiple digits if that occurred multiple errors at the same time.
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3.5. Barcode system for samples
3.5.1 Usable blood collecting tubes
Suitable blood collecting tubes

1. 5 mL 12.4 x 75 mm
2. 7 mL 12.4 x 100 mm
3. 7 mL 15.4 x 75 mm
4. 10 mL 15.4 x 100 mm
3.5.2 Readable codes
The following codes can be read by this system.

1. CODE 39 2. ITF 3.Industria12of5
4. Standard2of5 5. COOP2of5 6. NW-7
7. CODE128 8.GS1-128(EAN-128) 9. CODE93
10. JAN/EAN/UPC 11. GS1 Data Bar(RSS)
3.5.3 Readable number of characters and minimum bar width
1. The maximum readable digits； 18

2. Readable bar width； 0.5mm or larger than that
Type condition of bar code
JAN / Code GS1 Code
Code type Code39 NW-7 ITF 2of5
EAN 128 Data bar 93
Maximum digits
18 18 18 18 18 18 18
number
Minimum digits
5 5 5 5 5 5 5 5
number
Check digit of inspection × ×
Send the check digit ×
Start / stop
× ×
Sending of character
Start / stop Small
Kind of character character
JAN13
Reading of JAN JAN8
UPC-E
UPC-A
13
Output digits
UPC-E
The addition of system ×
code "0"
GS1-128
×
correspondence
Reading of GS1Databer All read
Industrial
Reading of 2of5
2of5
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V5.7
3.5.4 Barcode label position
Upper limit
Lower limit
Note: Label bottom should be more than 20 mm above the tube bottom.
If you use 12.4 x 100 mm (7 mL), label bottom should be less than 35 mm
above the tube bottom.
3.5.5 Setting of blood collecting tubes
Face barcode to outside.
Note: Bar code should be set to always face the outside of the tray.
Blood collecting tube setting are 72 positions (outside and middle side) of
the sample tray.
Use rubber gloves when handling blood collection tube.
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3.5.6 Sample barcode setting
To apply sample barcode system, System parameter modification is necessary.

① Clicking System button, System parameter screen is shown.
Click Comm. Settings button at the sub-menu.
Click
② Communication setting screen is shown.

③ Click input box [ON] in [Communication] row of [Host] area. Select All or
Appoint by clicking input box of [Request] area
④ Select the communication device Serial or LAN.
For "Condition setting", refer to "Chapter4, 4.9.7 Communication Settings
screen".
Communication setting screen
⑤ Select [by Sample ID] by clicking input box of [Sample ID mode] area.
⑥ Clicking >> button in [Sample ID mode] area, register End barcode.
Click OK button. If you do not use End barcode, skip this step.
End barcode setting screen
⑦ Click Order button.
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3.5.7 Explanation and caution for sample ID mode
Patient sample test
Sampling stops if barcode reading fails for 5 samples continuously.

Sampling stops if End barcode is read.
Procedure of sample addition in operation.
Do sampling stop operation and wait sampling stop. When sampling has
stopped, set an additional sample or samples at the next position of already
set sample on the sampler.
When end of run, analyzer starts barcode reading from No. 1 sample
position on the sampler.
When sampling has completed (Sampling stop), analyzer starts barcode
reading from input [Start No.] input box of routine Routine Menu screen.
State "Start" button is not pressed when the operation of the apparatus
becomes the final reaction cell washing conditions will.
If auto-rerun is ordered, never remove sample tray till all tests finish.
STAT sample
STAT sample tests is acceptable only under operation.
If you input common patient sample position numbers of sample tray into
[Start No.] and [Stop No.] in STAT sample order entry screen, these position
numbers are used as STAT sample position number.
When you use STAT positions (E-) for STAT sample test, as an item
registration, [E-] for [S No.] in Order entry screen. (No group order entry)
If the last on the measured specimen of emergency specimen for position (E
~). Read the bar code of the youngest position No. of sample tray.
If the last on the measured specimen is of general sample for position. Read
the bar code of the next position of interrupted by urgent sample
measurement position. Reading 5position bar code. Then to perform the
measurement if there is a specimen that has not been measured in the
meantime.
General sample for position of the measured in the same round, cannot be
used for emergency specimen.
To perform an emergency measure in the general sample for position, in the
case of the same position No. and the last specimen was measured to be
entered in the emergency interrupt [Stop No.], the bar code of the next
position of the [Stop No.] read.
Control sample
Select the [quality control specimen] in [the type of specimen] of specimen

reception screen, and the registration of quality control specimen.
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(It cannot be a group registration)

Measurement of quality control samples, click on the "QC start" button on
the monitor screen. For details refer to "Chapter 3, 3.2.10 measurement of
QC sample".
Calibration
No difference from common mode (without sample ID mode).

Calibration measurement results will not be sent to the host.
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V5.7
3.5.8 Method of measuring the specimen ID mode
1. Measurement request from the host.

2. Set the sample to the sample tray.
3. Click "Request" of Order screen. (If you select the "ALL" in the system
parameter)
4. Confirm measurement request content. (If you select the "ALL" in the system
parameter)
5. If necessary, in the "Start No." of the monitor screen, and then enter the bar code
reading start position number.
※ When the measurement is completed, the measurement results are
automatically sent to the host.
※ Even If you select the "Appoint" in system parameters, and performs the
"Request" in the acceptance screen.
In this case, you will need to enter the bar code ID to query. Normally, the device
will automatically query the host. When you import a sample bar code during
operation. This operation is not required.
3.5.9 Sample ID reading confirmation
Reading of sample ID is confirmed as follows.
Click
Stat
ID Sample No.
Sequence number
Order entry screen
ID List screen
1. Clicking Order button, Order entry screen is shown.

2. Clicking ID List button, ID list screen is shown.
3. This screen shows already read barcode ID.
If [Barcode] column is empty, there is no sample tube with barcode or reading
failure.
If the same position is used several times, several sample ID are shown in the
same row.
Explanation of status column: No Order, Order, Run, Complete, NG1 (Cup Error),
Error2
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3.5.10 On-line test results transfer by LAN
Using LAN system, on-line test results transfer is possible.
(1) Clicking System button and Sys. Param. Button.

System parameter screen is shown.
System parameter System screen
(2) Clicking Comm. settings button in the sub menu, Communication settings
screen is shown.
Communication Settings screen
LAN (Result send) area
(3) Click input box ON of [Communication] row, in [LAN (Result send)] section.
(4) Transfer condition registration.
TCP Receive port ：Accepting LAN port
Default is “3010”
Send port ：Default is “3011”
Delimit character Default is “,” (Comma).
IP address acquisition is automatic.
(5) Clicking Order button, following message box is shown.
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V5.7
(6) Click Yes button to register above condition.

※The modification will valid after system switch OFF and ON.
Message box
(7) Connect analyzer LAN port and PC LAN port with LAN cable.
Refer “Bi-directional Communication specifications LAN TCP/IP, in detail.
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3.6. Simple operation mode
Analyzer has Simple operation mode. Using this mode, operator can run analyzer
easily.
Here explain how to use Simple operation mode.
3.6.1 Profile setting for simple operation mode
Analyzer has Simple operation mode, based on Profile order entry.

Up to 4 Profile registrations are possible, and for each Profile up to 10 sample
positions are assigned.
This mode is suitable for the operator of Simple operation level. (The lowest priority
level)
Profile registration for Simple operation mode is not allowed for the operator of
Simple operation level. Higher operator priority level is necessary.
Profile registration for simple operation

(1) Click Maintenance button. Maintenance screen is shown.
Maintenance screen
(2) Click Profile for Simple operation button of [File maintenance] section.
Simple operation profile screen is shown.
Simple operation profile screen
(3) Select Profile number from pull down menu, by clicking button.
Profile Name and Round are shown automatically.
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V5.7
(4) Input Profile name.

(5) Select Reagent round from pull down menu, by clicking button.
(6) Selected specimen type.
(7) Select test items.
(8) Click Save button to save profile.
(9) Click Exit button to close Simple operation Profile screen.
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3.6.2 Adoption of simple operation mode
The measurement of Simple operation Mode is necessary after the setting by Login.
Adoption of simple operation mode is as follows.
(1) Startup analyzer

(2) Clicking Exit button at upper right of the screen, end of operation screen is
shown.
End of operation screen
(3) Clicking Log off button.

(4) Login screen is shown.
Login screen
(5) Input user name and password. Click Login button.

User Name：Easy (“E” is capital)
Password ：Blank (no password)
(6) System program starts under simple operation mode.
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V5.7
3.6.3 Operation of simple operation mode
(1) By the above operation, analyzer starts under simple operation mode.
Refer to “Chapter 3.6.2 Adoption of simple operation mode”.
The next Simple Operation Mode screen is shown.
Sample round
Sample position
Profile
Item Name
Item Name
Sample number.
Test results of the above sample are
shown below
Result
Simple operation mode screen
(2) As each Profile has own sample positions, set the sample at the sample position,
which belongs to the selected Profile.
(3) Select a Profile name out of Easy 1 to Easy 8.

As each Profile has own group of test items, select a proper one which includes
necessary test items.
※Sample number and sample position on a tray is closely related.

Therefore sample number is decided after sample cup is set on a tray.
The relation is followings:
Sample number 1 is the identical sample tray position 1.
Profile 1: Sample tray position 1 – 9
(4) Click the sample position of the selected [Profile] area, where the sample is set,
in Simple operation mode screen.
※Only one test is done under the same Sample round and sample tray position.
If you want to use the same sample position again, please change Sample
round.
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Sample round of Simple operation mode are 991 to 999.
(5) Click Start button.

Color of registered position changes depending on the test stage.
Order ： Button keeps pushed state.
Run ： Gray
Complete ： Blue
Error(Cup detection failure) ： Red
(6) When test has finished, test results shown in Simple operation mode screen.
If you want to see test results of another sample, click < or > button in sample
number box, to seek sample number of interest.
(7) Clicking Exit button at the upper right corner.
Exit from simple operation mode.

Clicking Exit button at the upper right corner, Login screen is shown.
Input user name and password and click Login button.
Refer to “Chapter 4, 4.12 Log Off, Log In screen”.
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3.7. Auto start
By using the Auto-start setting, analyzer power switch is ON automatically at the

time, which is set by the timer.
In addition, you can automatically set the cleaning operation or the like after
start-up. (After the system power ON).
3.7.1 Auto start setting
1. Automatic start-up (system power ON, OFF) setting
(1) Set the timer on the equipment front of the door.

※ For more information refer to "Chapter 4, 4.13 Time setting for automatic
start-up and change date confirmation screen".
(2) Set both of ON and OFF time. ON or cannot be set only OFF.
(3) Please be sure to set the timer output set (OUT) to AUTO. (The default
setting is ON)
※Please to state program that was launched. However, once a week
program turn off the PC power supply by closing.
Note: If you do to fit the automatic start-up operation setting and the system power
supply automatic ON by the timer setting.
Set before the automatic start-up operation start time the system power ON
time.
If the system power ON time was later than the automatic start-up operation
start time, it does not perform the operation that has been set.
2. Automatic operation setting after start-up (system power ON)

(1) Check "ON" of "auto start" in System-Configuration screen.
※For more information, Refer to "Chapter 4, 4.9 system screen, 4.9.8 Initial
setting screen".
(2) Click "Auto-start" in Maintenance screen. And then click the automatic
operation to be performed at the time of start-up.
※For more information, Refer to "Chapter 4, 4.11.3-2 Maintenance list
Screen, Auto start".
(3) After you have set the automatic start-up operation content, please restart
the system (program). Setting and restart will be reflected.
Note: If you do to fit the automatic start-up operation setting and the system power
supply automatic ON by the timer setting.
Set before the automatic start-up operation start time the system power ON
time.
If the system power ON time was later than the automatic start-up operation
start time, it does not perform the operation that has been set.
3-88
3.7.2 Automatic operation and screen display
1. Automatic start-up timer setting (system power ON, OFF)
※ Both the timer setting and automatic operation setting

(1) Automatically enters the system power when it comes to the timer setting ON
time. Then warm up state showing.
(2) Automatic start-up waiting screen will be displayed.
※If the automatic start-up waiting screen is displayed, you cannot be
operated in the other screen. If you do not turn off the system power, it
does not display.
Click Cancel, it will not work.
Automatic start time display
Automatic start-up waiting screen
Note: Click "Cancel" if you do not perform start-up automatic operation of the day.
(3) When it comes to standing up during automatic operation start time changes
to "Automatic start-up run screen", behavior that was set start.
※ If you do not turn off the system power, Automatic startup standby screen
even when the operation start time is not displayed. Start the operation
that was set up to display the execution screen.
② ③ ④ ⑤
⑥
⑦
Automatic start-up run screen
3-89
V5.7

① Display the current operation content.
② Represents the operation order.
③ Display the operation process content.
※ISE, even if you have set the calibration, ISE calibration does not
appear in the automatic start-up run screen.
※However, ISE calibration operation is I will first do best.
④ Display the time required for each action.
⑤ Display the processing state of motion.
○; Operation is completed
×; Operation failure
[Blank]; Not yet working
⑥ This button is stop button. Click if you want to stop the operation.
Will be displayed next stop confirmation screen.
Stop confirmation screen
⑦ Click if you close the screen. When all of the operation is finished button
is enabled.
3-90
2. If you do not want to set automatic start-up
Manually system switch ON. Only setting “automatic operation start-up run”
① Manually system switch ON.
② Automatic start-up waiting screen will be displayed.
※If the automatic start-up waiting screen is displayed, you cannot be
operated in the other screen. If you do not turn off the system power, it
does not display.
Click Cancel, it will not work.
Automatic start time display
Automatic start-up waiting screen
Note: If you ON the system power after the start-up operation start time set.
"Automatic start-up waiting screen" is not displayed. And it does not also set
worked.
If you do not turn off the system power.
① When it comes to standing up operation start time, display is "Automatic
start-up run screen". Will be setting works.
② If another operation was running in start-up operation start time set, does
not stand up when the automatic operation of the day.
Click "Cancel" if you do not perform start-up automatic operation of the day.
After the other operation prior to start-up operating time that is set, once in the
system power is OFF, if again you have to turn ON the system power, to display
again "Automatic start-up waiting screen".
③ When it comes to standing up during automatic operation start time changes

to "Automatic start-up run screen", behavior that was set start.
② ③ ④ ⑤
⑥
⑦
3-91
V5.7

① Display the current operation content.
② Represents the operation order.
③ Display the operation process content.
※ISE, even if you have set the calibration, ISE calibration does not
appear in the automatic start-up run screen.
※However, ISE calibration operation is I will first do best.
④ Display the time required for each action.
⑤ Display the processing state of motion.
○; Operation is completed
×; Operation failure
[Blank]; Not yet working
⑥ This button is stop button. Click if you want to stop the operation.
Will be displayed next stop confirmation screen.
Stop confirmation screen
⑦ Click if you close the screen. When all of the operation is finished button is
enabled.
3-92
Operator’s Manual Chapter４
Chapter 4
Screens and programming
4.1 Monitor screen ...............................................................................................................4-5

4.1.1 Function ..................................................................................................................4-5
4.1.2 Screen and detailed explanation .............................................................................4-6
4.2 Order entry .................................................................................................................. 4-10
4.2.1 Function ................................................................................................................ 4-10
4.2.2 Screen and its detailed explanation ...................................................................... 4-10
4.3 Test results screen ....................................................................................................... 4-19
4.3.1 Function ................................................................................................................ 4-19
1. Database................................................................................................................... 4-25
2. Report ....................................................................................................................... 4-30
4.4 Quality control ............................................................................................................. 4-32
4.4.1 Function ................................................................................................................ 4-32
4.4.2 QC sample name list screen.................................................................................. 4-33
4.4.3 QC range screen.................................................................................................... 4-35
1. Item selection menu screen ...................................................................................... 4-35
2. QC range setting screen ........................................................................................... 4-36
4.4.4 Current QC screen ................................................................................................ 4-37
1. Current QC screen ................................................................................................... 4-37
4.4.5 Daily screen .......................................................................................................... 4-39
1. Daily graph screen ................................................................................................... 4-39
4.4.6 Cumulative screen.............................................................................................. 4-40
1. Cumulative graph screen ......................................................................................... 4-40
2. Cumulative list screen.............................................................................................. 4-42
4.5 Reaction monitor ......................................................................................................... 4-43
4.5.1 Function ................................................................................................................ 4-43
1. Optical absorbance list external storage .................................................................. 4-46
4.6 Item parameters .......................................................................................................... 4-47
4.6.1 Function ................................................................................................................ 4-47
4.6.2 Common test Item parameter screen.................................................................... 4-47
1. Item selection menu screen ...................................................................................... 4-47
4.6.3 Serum information................................................................................................ 4-57
4.6.4 ISE Item parameter screen ................................................................................... 4-60
4.6.5 HbA1c parameter screen ...................................................................................... 4-63
1. HbA1c Item number screen ...................................................................................... 4-63
2. HbA1c Item number 101 and 102 screen ................................................................. 4-64
3. HbA1c Item number 106 screen ............................................................................... 4-70
4-1
V5.7
4.6.6 Calculation between Items screen ........................................................................ 4-79

4.6.7 Detergent screen .................................................................................................. 4-82
1. Detergent volume setting, dilution bottle setting ................................................... 4-82
4.7 Reagent parameter screen .......................................................................................... 4-84
4.7.1 Function ............................................................................................................... 4-84
4.7.2 Screen and detailed explanation .......................................................................... 4-84
4.8 Calibration screen .................................................................................................... 4-89
4.8.1 Function ............................................................................................................... 4-89
4.8.2 Screen and detailed explanation .......................................................................... 4-89
1. Calibration screen.................................................................................................... 4-89
2. Calibration graphics screen ..................................................................................... 4-95
4.9 System screen.............................................................................................................. 4-97
4.9.1 Function ............................................................................................................... 4-97
4.9.2 System parameter screen ..................................................................................... 4-98
4.9.3 Date / Print screen.............................................................................................. 4-101
4.9.4 Wash 1 screen ..................................................................................................... 4-103
4.9.5 Wash2 screen...................................................................................................... 4-105
1. Sample Probe Wash (In case of by Item) ................................................................ 4-105
2. Sample Probe Wash (In case of by Specimen) ........................................................ 4-106
3. Sample Probe Wash (In case of by Sample) ........................................................... 4-107
4.9.6 Version information screen................................................................................. 4-108
4.9.7 Communication setting screen ........................................................................... 4-109
4.9.8 Initial setting screen .......................................................................................... 4-113
4.10 Simple operation screen ............................................................................................ 4-116
4.10.1 Function ............................................................................................................. 4-116
4.11 Maintenance screen................................................................................................... 4-118
4.11.1 Function ............................................................................................................. 4-118
4.11.3 Maintenance list screen...................................................................................... 4-120
1. Maintenance list .................................................................................................... 4-120
2. Auto stert ............................................................................................................... 4-120
3. Monitor .................................................................................................................. 4-122
4.11.4 File maintenance screen ............................................................................... 4-123
1. ProFile ................................................................................................................... 4-123
2. Sample File ............................................................................................................ 4-124
3. Item File ................................................................................................................ 4-125
4. QC File ................................................................................................................... 4-126
5. Profile for Simple operation ................................................................................... 4-127
4.11.5 Analyzer maintenance screen ............................................................................ 4-128
1. User Maintenance.................................................................................................. 4-128
2. ISE ......................................................................................................................... 4-130
3. Cell Check .............................................................................................................. 4-139
4. LAMP..................................................................................................................... 4-141
4-2
5. Error List Screen .................................................................................................... 4-142

6. Result Log .............................................................................................................. 4-143
7. Clot Sensor ............................................................................................................. 4-145
8. Auto-gain ................................................................................................................ 4-146
9. Cell Skip ................................................................................................................. 4-147
4.11.6 Service engineer maintenance screen ............................................................... 4-148
4.12 Log Off, Log In screen ................................................................................................ 4-149
4.13 Timer setting and date change confirmation screen .................................................. 4-150
4.13.1 Timer setting ...................................................................................................... 4-150
4.13.2 Date change confirmation screen ........................................................................ 4-152
4-3
V5.7
4-4
4.1 Monitor screen
4.1.1 Function
This screen is the main screen, which is used for selection operation such as
analyzer operation control, routine operation program, circumstance setting
program and analysis condition setting program selection. And also displays
run monitor and analyzer status monitor Input and setting of sample number
test range is possible in this screen. Each switch and button has the following
function.
Analyzer operation control
Ready ---- Analyzer initialization

Start ---- Order of test start
Calib Start ---- Order of Calibration
QC start ---- Order of QC test start
E.Stop ---- Stop order for all mechanical units, while in
operation
Sampling Stop ---- Order of sampling stop, while in operation
Stat ---- Order entry and test start of STAT sample
Error List ---- Displays an error list of the day.
Exit ---- Analyzer shutdown order, priority level switching
Routine operation
Routine Menu ---- ORD_STATU, Run monitor and reagent information

display
Order ---- Order Entry
R&E ---- Display and edit of test results for each sample
R-Mon ---- Reaction monitor display
Daily Result Log ---- Results of the analysis on the day
ORD.STATU ---- Reception time, Specimen situation (analysis moderate
etc.), Measurement scheduled end time
R-monitor ---- Reaction situation in tabular form
Reagent information ---- Reagent registration status
ISE ---- ISE cleaning, ISE calibration result, Flow sensor
value
Condition setting
Calibration ---- Calibration order entry and result display

QC ---- QC sample order entry and result display
Reagent ---- Reagent bottle position and residual amount setting
Item ---- Various conditions setting for Test Item parameters
Environmental setting
System ---- System condition and special function setting

Maintenance ---- Maintenance function setting and order
4-5
V5.7
4.1.2 Screen and detailed explanation
Analyzer status monitor Temperature monitor
Run monitor
Status message
Routine Menu screen
Routine Menu A button, which is used to open the Routine Menu

screen.
Calibration A button, which is used to open a screen for

standard sample No. setting, sampling repetition
number setting for multiple times measurement and
optical absorption data display of test results.
Q C A button, which is used to open QC management

menu screen as QC management function.
Reagent A button, which is used to open a screen for reagent

round setting, reagent bottle position setting and
reagent residual amount setting.
Item A button, which is used to open a screen used for various

condition setting of item parameter.
Simple operation A button, which is used to open a screen for simple

Operation. Refer to “Chapter 3.7.2 Adoption of simple
Operation mode”.
System A button, which is used to open System menu screen for

system condition setting.
4-6
Maintenance A button, which is used to open Maintenance menu screen

for maintenance function.
Order A button, which is used to open a screen for order entry.
R&E A button, which is used to open a screen for test results

display and edit of each sample and rerun sample results display.
R-Mon Reaction process monitor switch, which shows optical

absorption data of all reaction process and its graphic display.
Ready A switch, which makes all analyzer mechanical units to initial

state.
Start This switch gives an order to start measurement, if analyzer is

[Ready] state.
QC start When this button is ON, clicking the button starts tests for
QC sample which test order has already entered
This button is ON, while under Ready state and sampling stop
state.
E.Stop This switch is used to let emergency stop while analyzer is

running.
Sampling Stop This switch is used to stop sampling, while in operation.

Item of sampling of the first reagent dispensing already as
soon as the end, it will be sampling stop state.
STAT This switch is used to insert sampling for STAT sample.

Analyzer goes to emergency cutting in mode right after the
sampling of current sample and current item
Error list Displays an error list of the day.
ISE Displays ISE maintenance screen.
ISE Wash ISE cleaning button

Calb.result Display ISE serum calibration result.
Flow sensor Display ISE flow sensor value.
4-7
V5.7
Exit This switch is used to shut down analyzer when test has
finished and Priority level switching.
[Temperature monitor]
Displays analyzer temperature control state.
Shows [---], [WARM-UP] or [TEMP-OK].
[Analyzer status monitor]

Displays analyzer operation state.
[OffLine], [IDLE], [READY], [INIT], [RUN], [S.STOP]
[STAT] or [END]
Daily Result Log Display the results of the measurement day.

Displaying and printing Daily Result Log are available even
during measurement. There is no function to select items to
display.
Display contents are as follows.

Date / Title ; date and time
S_RND_No ; Round number
SAMP_No ; Sample number
Barcode_ID ; Bercode ID
R_Mon.No ; Reaction monitor number
Type ; Specimen type
Test ; Item name
Result ; Results (Standard specimens
display the absorbance)
P_Flg ; Data message flag
S_Flg ; Liquid out flag
Dil. ；Dilution ratio
※ For the error flag information, refer to "Chapter 6
Check flag・Alarm Function".
Search method
① Select the specimen to be displayed.
② Click Update button.
4-8
Printing method
① Select the result row and click the Add line
button.
② The selected row is displayed in .
※ If you intend to print lines of 1-10 and 21-30, enter
"1-10, 21-30" in
③ Click Print button to print.
ORD_STATU Sample round, Sample number, Sample state, Scheduled

date, RST date.
R-monitor Run monitor is shown by table format.
Reagent info. Reagent name, bottle position and residual volume are
shown by table format.
[Status message] Displays analyzer status message
4-9
V5.7
4.2 Order entry
4.2.1 Function
This screen is used for new order entry, modification or deletion of test
items for the samples, except standard samples, and above function is
possible even test is running. You can designate a sample round and
position in order to measure sample.
Note： Order entry of standard sample number is performed in “Chapter

4.8 Calibration screen”.
4.2.2 Screen and its detailed explanation
Order entry Screen
R.Round * ** Round number and Round name, registered in

round parameter, are shown.
*means Round number and ** means Round
name.
File Date * The date of today is shown as default display.

If an operator wants to refer previous data, clicking
this box, the former tested date list is shown.
Clicking a date from pull down list, sample
information of the day is shown.
It is not possible to edit and delete past test order and
results.
Test order of rerun sample is stored in the same date of
the original run.
4-10
Round – S.No. * ** There are 2 input boxes for sample Round No.(*)
and sample No.(**) * means Round No. input
and ** means sample No. for new order entry,
reference, modification and deletion.
Click the box, and do the following input operation.
Sample round No. ＋ Enter

Sample Round: You can input to 1-900.
Quality control: you can input to 1-902.
Sample No. (position) ＋ Enter

You can input a following number as sample position.
Calibration : 1~72
Patient : 1~72
QC : C1~C30
STAT : E1~E30
Barcode ID Displays a character string of read barcode.

Sample ID mode of System Comm. settings is set as
［By sample ID］, barcode character string input is
possible.
Patient Information It is possible to be no input.
Patient ID Input patient ID of patient information. (If you want to

register patient information, this is a necessary operation.)
Name Patient name of patient information is shown automatically.

Input by letter string.
Sex ｜ Select patient sex from male, female or unknown.
Date of Birth Input patient date of birth.
Age Patient age is shown automatically, calculated from date of

birth.
For the child less than one year, show months
and days.
It is possible to input age directly without date of
birth input.
Draw Date Blood taking date of patient information is shown

automatically.
Modification by manual input is possible.
4-11
V5.7
Doctor Input the name of doctor in charge.

The doctor name is registered by hitting Enter key.
Section Input the section in the hospital.

These is registered by hitting Enter key.
Trace sample Check the when you use to put the sample cup in a
test tube or adapter.
Sample information
Comment 1 Select serum information out of Hemolysis、Lipemia

and Bilirubin.
Judge by eyesight and input comment on that.
Comment 2 This is the free comment area.
Test condition
＃of Asp ＊ Sampling repetition number from the sample setting

(1 to 10) Clicking the box.
Sampling number and hit Enter key.
Specimen Specimen Sample kind selection

Select one from the list box, serum, urine, plasma,
CFS, Dialysis and Other.
Default is serum.
Control Control sample name input box by selection from pull

down menu. Select one from registered names in pull
down menu or blank. If no QC is necessary, select
blank.
Note : Please refer to Chapter 4.4 Quality control.
Sample Status Test progress status is shown automatically.

There are 6 statuses: Order, Run, Complete, Clear,
Error1 and Error2.
Default is “Clear”.
Sample Type Based on the sample number inputted in No. box,

sample type (patient sample, standard sample, QC
sample and STAT sample) is shown automatically and
set.
4-12
Default is “Patient sample”.

Select “QC smple” or “STAT sample”, the followin
Round − S.No. is shown.
Order Status * Displays either “Order” or “Rerun” to tell that

displayed sample information is normal sample or
rerun sample.
Default is “Order”.
Test Item
* Name Test item list

Registered test item list of selected round.
レ UA Order box
When item name is clicked, a check mark
appears at the left box.
If click the item name again, order is cancelled.
In case of rerun --- At the end of the test, already
tested item name is shown in blue color. Input a
check mark to do rerun order entry.
Dil
UA * | Dilution ratio box
Sample dilution ratio setting (13 kinds)
Clicking desired dilution ratio in dilution ratio list, the
ratio is written into the box.
Select the desired ratio or select the blank to cancel.
レ Na，K，Cl This box is active when ISE is selected in system

screen.
Clicking the item name, a check mark appears at
the left of the item name box.
In case of rerun --- At the end of the test, already
tested item name is shown in blue color.
Input a check mark to do rerun order entry.
Compute The calculation item set by the item parameter is

shown.
Clicking the item name, a check mark appears on
the left of the item name box.
In case of rerun
At the end of the test, already tested item name
is shown in blue color.
Input a check mark to do rerun order entry.
Order All All the test items are ordered together.
4-13
V5.7
Clear All All the test items are cleared together.
ProFile Profile dialog box is shown in Order entry screen at

the right.
A Profile list, registered in File Profile screen, is
shown. Select from the list and double click it,
item registered in selected profile are ordered.
Note : Refer to 4.11.4 File Maintenance screen for Profile

registration.
Profile screen
Former sample number search switch button 1

Clicking this button, order entry information of the
smallest sample number within the registered sample
numbers is shown.
Former sample number search button 2

sample, one before the current sample number is
shown. If there is no sample number registration,
this function does not work.
Search switch button

Clicking this button, registered sample information
of current sample number appears.
Later sample search switch button 2
Clicking this button, registered sample information o
the sample one larger than current sample number
appears.

largest test sample number within the registered
sample numbers is shown.
If there is no sample number registration, this
function does not work.
New Sample screen display clear button
4-14
Clicking this button, all data in the screen has

cleared.
No registration is deleted.
G.Order Group order entry button

Multiple samples having the same test items are
registered together.
Clicking the button, the following group order entry
screen is shown.
Starting sample number of the Group order entry is
the same as the current sample number in Order
entry screen.
End sample number input:
Input the last sample number of the group.
If you want to change starting sample number, you
have to go back to Order entry screen and input a
new sample number.
Clicking OK button or Cancel button, this dialog box
disappears.
G.Delete Group delete button which is used to delete the order

of a grope of multiple samples of the same items is
deleted together.
Clicking this button, the following Group entry delete
screen appears. The displayed sample number is
inputted to the Start Sample No. automatically.
If you want to change starting sample number, retype
the start sample No.
End sample number input: Input the last sample
number of the group.
Clicking OK button or Cancel button, this dialog box
disappears.
Order Clicking this button, the sample information of Order

entry screen is stored in Sample file.
Delete Clicking this button, the sample information of Order

entry screen is deleted from sample file.
Request This button appears above the Round – S. No.

box, when Host communication is set as ON, in
system communication setting.
Refer to 4.9.7 Communication setting screen.
4-15
V5.7
Host Request screen
When clicked, depending on the Host

Communication setting, one of the following dialog
box appears.
In case of “All” In case of “Appoint”
In case of “All”:
Clicking YES button, Host is requested to send the
information.
In case of “Appoint”:
Input Start sample ID and End sample ID. The inputted
ID No. information is requested to the HOST by clicking
this button.
Work list Clicking this button, a list is shown which is used

to confirm registration contents under order entry,
measurement and after the measurement, and
ordered item list.
Work list screen
Sample Clicking button, select

Patient sample type to display.
Select one from Patient,
Control
Control, Stat and All.
Stat
Reagent Round No.
4-16
01 Clicking button, select

02 reagent round to display.
Select one from 01−10.
03
Order State Clicking button, select

Order order status to display.
Re-run order Select one from Order, Re-run
order and Auto-rerun order.
Auto-rerun order
File Date
Clicking button, select File
2011/01/19 date to display.
2011/01/18
2011/01/17
Clicking Print button, printout is possible by the

external printer.
Clicking Exit button, back to the Order entry
screen
Setting of sample ID
When setting by Sample ID in the communication setting screen of system

screen, the part of the screen
display is changed. Refer to 4.9.7 Communication setting screen.
ID List When sample ID mode is "by sample ID" setting,

ID List button is shown above Round- S. No. box.
The left upper part of Order entry screen
4-17
V5.7
ＩＤ list screen
Clicking ID list button, barcode data are shown

The following information is shown in Status box.
ID ・・・・ ID number is shown.

When order is entered, ID is
shown at the bottom of the list.
Sample No.・・Position number is shown.
If the same position is used
several times, multiple IDs are
shown at the position.
Status ・・・ No Order, Order, Run, Complete,
Error1, Error2.
4-18
4.3 Test results screen
4.3.1 Function
This function is used to refer, modify or delete the test results.

Test results are shown as the sample base.
Comparison of the rerun results with the former results, and the rerun order entry
and the dilution rate registration are possible in this screen.
Results display screen
R. Round * ** * means Test round means display

** means Round name display
File Date * means File date selection

Default is the date of today.
Clicking this box, former tested file date list is
shown.
You can select the desired date by clicking from
the list.
File date list box scroll is possible by and
buttons. When a date is selected, information of
the youngest sample number of the day is shown
automatically.
Round-S. No. * ** * means Corresponding Soft tray No. key input

** means Sample No. key input for search.
Round No. ＋ Enter
Sample No. ＋ Enter
Barcode ID * Barcode ID display of selected sample number.
Patient ID * Patient ID display
4-19
V5.7
Name * Patient name display
Sex * Patient sex display (male, female or unknown)
Date of birth * Patient date of birth display
Age * Patient age display (For the child less than one year, show
months and days).
Draw Date * System date of blood taking display
Doctor * The name of doctor in charge display
Section * The section in the hospital display
Trace samples * This means whether you use test-tube or sample cup.
File Date * Date and time of the test display
#of Asp * Sampling repetition number display
Specimen * Sample kind display (Serum, Urine, Plasma, CFS,

Dialysis)
Control * QC sample name display
Sample Status Sampling status display
Sample Type * Based on the sample number input, sample type

(patient sample, standard sample, QC sample and
STAT sample) is shown.
Order status * Displays either “Order” or “Rerun” sample.
Comment１ * Serum information display（ Hemolysis, Lipemia,

Bilirubin）
Comment２ * Comment on the patient display
Name Dil Rerun order box

* UAL Clicking this box, a check mark appears in the
box which shows rerun order is entered.
For rerun result, check mark appears already.
Name Dil Tested test item name display

*
4-20
Name Dil Sample dilution ratio setting (14 kinds)

Dilution ratio list box for the test item with order
mark is shown. dilution ratio list contains blank,3,
5,6,10,20,30,40,50,60,70,80,90,100.
Set desired dilution ratio by clicking the ratio in the list.
Result Test results display and result edition, referring rerun

results.
To do test results edition follow the procedure below.
Click the box and delete the result by BS key.
Input Number + Enter.
Qualitative The quantitative value of result is converted into

the optional qualitative one.
For this function, the qualitative values should be
set in Item screen.
RC Reaction monitor screen display
NR If test result is higher than registered normal range

H and L are shown.
If the result is given by calibration recalculation
function, * mark appears.
Unit Test item unit display
Data message Data check code of test result display

Refer to “Chapter 6, 6.1.1 Data message flag”.
Short S--- Short liquid check flag display

Refer to “Chapter 6, 6.1.2 Short sample/reagent check
flag”.
Former sample number search switch button 1

Clicking this button, sample test result of the
smallest sample number within the registered
sample numbers is shown.
Former sample number search button 2

Clicking this button, sample test result of the
sample, one before the current sample number is
shown. If there is no sample number registration,
this function does not work.
Search switch button Input sample number you want to

search and clicking this button, sample test result of
current sample
number appears.
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V5.7

Clicking this button, sample test result of the sample
one larger than current sample number appears.

Clicking this button, sample test result of the largest
sample number within the registered
sample numbers is shown
Print Clicking this button, test results on the screen are

printed out.
Save When enter rerun order or edit the test results, it is

necessary to press this button. (In case of rerun order,
if you order rerun in this screen, rerun order box of
order screen is also automatically registered.)
HOST Send This button is used to send test results to Host

computer. When Host communication is "ON" setting in
Comm. Settings of the system screen, Host Send
button is shown above Round – S. No.
Refer to 4.9.7 Communication setting screen.
1. Clicking this button, depending on the Host

communication setting, the following Host transfer
screen is shown.
(In case of “by Sample No”) (In case of “by Sample ID”)
Host Send screen
2. Host Send button is used to send a batch of test

results to the Host.
1). When performing a batch transmission of test
results in the past, change the system date into
the desired date for transmission by clicking
System and Date/Print.
4-22
2). When completing, be sure to change the date back.

The results in the past cannot be transmitted during
measuring.
Note; If the analyte in the analysis to host transfer,

"There is no transmission possible results."
To pop up an error message that.
(It does not rest on the history of the error list.)
From measurement of the specimen is completed, be sure
to host transfer.
Database This button is used to display various data list.

Clicking the button, the following menu is shown.
Database menu screen
Database
Results Test results list display and print out is
possible.
Patient History
Sequential test results display for one
patient and print out and graphic
display is possible.
Abnormal Value
Abnormal test results list display and
print out is possible.
Abnormal Range setting

Set the abnormal range for each test
item.
Pending List Unfinished tests list for already tested

samples display and print out is possible.
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V5.7
Report
Single Report Patient single report format.
(Please refer to the input of patient ID)
Cumulative Report
Patient cumulative report format.
(Please refer to the input of patient ID)
Print Settings Set the order and number of test items,

included in the test results, abnormal
results and unfinished test.
Less than 10 kind formats is
acceptable.
Error Expression
In case that data error occurred, you
can select whether to print out the
result in value or in asterisks“******”.
Header Settings
Inputting header of report is possible.
Exit Test result screen is shown.
Note To use above printing function, an external printer

should be connected and also proper printer driver
is installed.
4-24
1. Database
(1). Results
Clicking Database and Results buttons in R&E screen, the following
screen is shown.
Test result list screen
Run Date The latest measurement date is displayed as default.

To show the results in the past, select one in the date
list.
Search Clicking this button, the following search condition dialog

box appears.
Search screen (Test results)
To search test result, input sample No. under the

Sample No. mode, and input sample ID, patient ID or
patient name under the Sample ID mode, and then click
Search button.
For showing all the data, just click Search button
without inputting anything. (On the screen, back color
changes to light blue for each 5 lines.)
Print Printout is possible by external printer. Clicking the

button, following screen is shown.
Select “Print Item” number by clicking, and click Print
button to start print. The contents of Print Item
number has to be registered in Print settings in
Database menu screen.
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V5.7
Print list selection screen
Exit Clicking this button, screen back to Database menu screen.
(2). Abnormal value

Clicking Database and Abnormal Value buttons in R&E screen, the
Beforehand, it is necessary to set the abnormal value range for each
item in [Abnormal range setting] of Database menu.
Abnormal value list screen
Search Clicking this button, the following search condition

dialog box is shown.
For searching, input sample No. under the date or
sample No. mode, and Sample ID under the sample
ID mode or patient ID, and then click Search
button.
Search screen (Abnormal data)
Print The data can be printed out, using the external

printer.
Printing operation is the same as “1. Test Results”.
Exit Clicking this button, screen back to Data list menu
screen.
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(3). Pending list

Clicking Database and Pending list buttons in R&E screen, the
● The mark is put to a pending item.
Pending List screen
Search Clicking this button, the following search condition dialog

Box is shown.
For searching, input date range, sample No. under the
sample No. mode, and sample ID or patient ID under the
sample ID mode, and then click Search button.
Search screen (Untested)
Print The data can be printed out, using the external printer.
Print operation is the same as “1. Test results”.
Exit Clicking the button, the screen goes back to Data list
menu screen.
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V5.7
(4). Patient history

Clicking Database and Patient history buttons in R&E screen, the
Patient history screen
Search Clicking this button, the following search condition

dialog box is shown.
Search screen (History)
For searching, input date range, sample No. under the

sample No. mode, and sample ID or patient ID under
the sample ID mode, and then click Search button.
Print The data can be printed out, using the external printer.
Exit Clicking the button, the screen goes back to Data list
menu screen.
Graph By the following procedure, the test results of each item

are shown graphically.
1) Clicking item name.
2) Clicking Graph button, the confirmation dialog box
appears.
3) Clicking Print button, the graph is printed out.
Printout is possible by only external printer.
When clicking Exit button, the display goes back to
History screen.
History graph screen

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(5). Abnormal range settings

Clicking Database and Abnormal Range Setting buttons in R&E
screen, the following screen is shown. Abnormal range (low and high)
of reach test item are set here.
Select the other

Item name kind than serum
and urine from this box.
Abnormal data range setting screen
Delete Select a data to delete and click this button.
Save Select a data cell to save by clicking, and click this button.
Print Clicking this button, abnormal data range setting list

is printed out.
Exit Clicking the button, the screen goes back to Data

menu screen.
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V5.7
2. Report
You can show the patient single report screen or the cumulative report screen by
clicking the button.
(1). Single report

The following format is printed.
(2). Cumulative report

The following format is printed.
(3). Print settings

Clicking Database and Print setting buttons in R&E screen, the following print
setting screen is shown. Set items and order of printout here. Each list can set, up to
10 kinds of printing order and number of items to be printed.
① Select one List name.（Normal, Abnormal or Pending）

② Select Print Item List No.
③ Select the item out of item list box and double-click. So the clicked item is inputted
in the blank cell.
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④ Click Save button to save the setting.
Delete Selecting the cell to delete and clicking this button, the item will be
deleted.
Exit Clicking the button, the screen goes back to Database menu
screen.
(4). Error expression

Clicking Database and Error Expression buttons in R&E screen, the
Select the style of printout between “value” and “*****” for the Level Error, the ABS
Error and the Multi-CAL Error by clicking Save button.
When setting the value, the data are printed out.
When setting *****, ***** is printed out.
Error expression screen
Save Clicking this button, the inputted Error Expression setting are
saved.
Exit Clicking the button, the screen goes back to Database menu
screen.
(5). Header /Footer settings

Setting screen of header information of each report.
You can input institution name, address and phone number and so on.
The information will be registered by clicking the OK button.
Header Setting screen
(6). Exit Clicking the button, the screen goes back to R&E screen.
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V5.7
4.4 Quality control
4.4.1 Function
Quality control of this system is managed by the following technologies.

LEVY-JENNINGS PLOT, BAR CHART, WESTGARD MULTI-RULE CHART
XB-R.
You register a profile (name, position of measurement, item of measurement
etc.) beforehand. You can order a sample of Quality Control easily. Please
see the 3.4.2 about method of registration of profile.
Clicking QC button, the following QC menu appears.
Current QC screen
Select the function by clicking the button.
Current QC The latest QC operation list screen for each item.
Daily QC graph screen for each run date
Cumulative Day to day QC operation screen
Controls QC sample information

(Name, Lot No. Exp.Data and set position)
QC Range QC parameter setting screen
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4.4.2 QC sample name list screen
Clicking Controls button in QC screen, the following Control name list

screen appears. Up to 30 kinds of QC sample registration is possible.
Registration of Control sample name, set position on a sample tray and test Items
(QC sample profile registration), makes order entry of control sample easy.
QC sample name list screen
Name
CTRL-1 * QC sample name
｜ After clicking the box, Name + Enter key
CTRL-30 *
Lot No. QC sample Lot No.
Exp.Date QC sample expiration date
Position 1 QC sample test position designation

｜ To input set position, click button at the
Position 6 right and select the position from pull down
menu.
Save Clicking this button, the data setting will be

saved.
Delete Clicking this button, the data will be deleted.
Item select This button is used to register test items of each

control sample. Clicking Item select button,
QC Profile Item select screen shown.
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V5.7
QC Profile Item select screen
You make the profile registration. (Every quality control

specimen name)
When you make a profile registration and quality control
specimen name selected, and then display the measurement
position and automatically profile registered items.
Profile Name QC Profile name is shown.

Raund Round number input box [Test item list]
Select necessary test items for the Control
sample, by clicking item name.
Save Clicking this button, the profile setting will
be saved.
Delete Clicking this button, all contents of the screen
are deleted.
Exit Clicking this button, screen backs to QC
sample name screen.
The method of registration of profile for QC sample.

① You register a name of QC sample, Lot No., Expiration date and sample
position at a list of control name.
② You register a item.
③ You select a QC name for setting of profile at a list of control name.
④ You click a Item select button.
⑤ You select a reagent round from Round button.
⑥ You click a check box which you want to register.
⑦ You click Save button.
⑧ Finally, you click exit button.
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4.4.3 QC range screen
This screen in used to set QC parameter of Control samples. Control sample

registration in Control name list screen is necessary before hand.
Clicking QC range button in QC screen, the following Item selection menu
screen of QC parameter appears.
1. Item selection menu screen
Item selection menu screen
Item Name * **
These boxes are used for Item parameter setting of each
item.
* means this test item number
**means item name
Firstly click in the * box first, then click item name.
Control Control sample name, registered in Control name list

CTRL-1 ： ** screen, are shown.
|
CTRL-30：
Save Clicking this button, the data setting will be saved.
Delete Clicking this button, the parameter data will be deleted.
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V5.7
2. QC range setting screen
Clicking Item Name in QC range menu and select item, following QC range
setting screen appears.
QC range setting screen
This screen is used to input the following target values for each registered QC
sample. Target value of data range, mean and SD.
・Range
・Mean
・SD
QC range setting screen
Item Name You click button and choose a test item
Magnification Input magnification enter the SD management range.

(1~3)
(If you want ±2SD, you enter 2 in magnification.)
※ The SD management range for all items is set at the
same magnification.
Different magnifications for each item cannot be set.
Range Mean SD After clicking each box, you can input a target value of
QC and click Enter key.
Low、 High These boxes are automatically input.
Save Clicking this button, all parameters of selected item is

stored.
Delete Clicking this button, all parameters of selected item is

deleted.
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4.4.4 Current QC screen
Clicking QC button and Current QC button, the following Current QC

screen appears.
In this screen, the latest test results of QC samples are shown.
Current QC edition screen
Control Name01：* This box is used for QC sample name input.

Clicking this box , QC sample list, which is set
by name setting, is shown.
Select one QC sample of interest and click it.
Lot No. * Displays QC sample lot number.
Exp.Data Displays QC sample effective date.
Date/Time Last Run Displays tested date of shown test results.
Rerun Rerun order entry of QC sample is possible by

input a check mark(レ) into the rerun order box.
Test Displays item name.
Pos. No. Displays sample tray position number, used for

the QC sample test.
Result Displays test results.

Data edition is possible by clicking. After the
edition, save the data by clicking Save button.
(No save operation for the User level operator)
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V5.7
Unit Displays unit.
Min Displays the minimum value of control range Mean value,

inputted in parameter, minus 2SD.
Max Displays the maximum value of control range

Mean value, inputted in parameter, plus 2SD.
P Displays P flag.
Refer to “Chapter 6, 6.1.1 Data message flag”.
S Displays Level error flag.

Refer “Chapter 6, 6.1.2 Short sample/reagent check flag ”.
Error Code Displays P flag with easy understanding expression.
Print Prints Current QC. (External printer)
Delete Deletes test results of selected QC sample.
Save Store the edited test results.
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4.4.5 Daily screen
1. Daily graph screen
Clicking QC button and Daily button, the following Daily QC screen appears.
In this screen, the test results graph within a day of QC samples are shown.
Daily screen
Control QC sample name display.

Clicking the box , QC sample list is shown.
Select one QC sample from the list.
Lot No. Lot number display for QC sample 1

Clicking the box , Lot No. list is shown.
Select the Lot No. from the list.
Run Date Selection of running date.

Clicking the box , running date list is shown.
Select the date from the list.
Print You can print out a Daily screen. (External printer)
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V5.7
4.4.6 Cumulative screen
1. Cumulative graph screen
Clicking Cumulative button in QC menu screen, the following Day to day

QC results screen is shown.
Cumulative screen（Graph）
Control Name QC sample name display.

Clicking the box , QC sample list is shown.
Select one QC sample from the list.
Lot No. Lot number display for the QC sample.

Clicking the box , Lot No. list is shown.
Select the Lot No. from the list.
Item Name Selection of setting test item.

Clicking the box , item list is shown.
Select the item from the list.
File Date ∼ The starting date of setting date range.

Clicking the box , date list is shown.
Select the date from the list.
File Date The ending date of setting date range.

Clicking the box , date list is shown. Select the date from
the list.
Graph Clicking shows Day to day QC graph screen
List Clicking shows Day to day QC table screen
Print Clicking this button, Day to day QC graph is printed by

external printer.
Graphic screen scrolls to the right or left by clicking.

This button is active, when set sample number exceeds
50.
4-40
How to see graph
Westgard notation
Mean graph
Number of test results
Old New If the graph width is to

big for one page, arrow
Variation width graph
mark buttons will be
active for scroll.
Day to day QC graph
Upper part of the graph shows Mean value graph.

Green line : Mean value set by parameter (Day to day QC)
White line : Mean value of test results
Yellow line: The range, ± SD from the mean (Depending on the number of
parameter)
Red line : The range, ± 3SD from the mean (Depending on the number of
parameter)
Westgard notation Displays Westgard error notation. Indication at the upper

part of the graph Error code (A to F)
When data error occurs, a mark A to F sticks to the data.
A ：If QC sample data exceeds +/-2SD, accidental error is in

expectation.
B ：If QC sample data exceeds +/-3SD, accidental error is in
expectation.
C ：If two kinds QC sample data exceeds 2SD in the same direction, or
tow continuous data of the same QC sample xceeds 2SD in the
same direction, systematic error is in expectation.
D ：If the SD range of two kinds QC sample data exceeds 4SD, or SD
range of the same QC sample data exceeds 4SD, accidental error is
in expectation.
E ：If two kinds QC sample tow continuous data exceeds 1SD in the
same direction, or four continuous data of the same QC sample
exceeds 1SD in the same direction, systematic error is in
expectation.
F ：If two kinds QC sample five continuous data appears in the same
direction, or ten continuous data of the same QC sample appears
in the same direction, systematic error is in expectation.
Lower part of the graph shows variation width graph.

Variation width graph is the graph, which shows the maximum variation width of QC
sample test results, if the sample is tested more than twice a day.
4-41
V5.7
If the sample is tested once a day, variation width of the sample is shown as 0, in the
graph.
Central part / between the graphs shows the data of statistic calculation.
Statistics calculation
Test count * :Test number display in the set range.

Mean * :Mean display in the set range.
SD * :Standard deviation display in the set range.
CV (%) * : Variation coefficient display in the set range.
Min * :Minimum value display in the set range.
Max * :Maximum value display in the set range.
Range * :(Maximum value – minimum value) display in the set range.
Exp. Data * :Effective date of set QC sample display.
2. Cumulative list screen
Clicking Cumulative,List button, you can see a following screen.

You can see a result list of QC.
Cumulative screen （List）
For the settings, refer to the 1. Cumulative graph screen.
Control Name, Lot No.,Item Name,Date,test count,Mean,SD,CV (%),

Min.,Max.,Range,Exp. Date
4-42
4.5 Reaction monitor
4.5.1 Function
This is used for optical absorption data of all reaction process and graphic
display.
This screen can display test results of main-wavelength, sub-wavelength and
the difference between two wavelengths.
Clicking R-Mon button in QC screen, Reaction monitor screen is shown.

To see the reaction process of specific test, it is necessary to input Reaction monitor
number of the test. The other way to open this screen, is clicking RC button of test
item, located at the right of test result column in test results screen.
Reaction monitor screen
RC ＃ * Reaction monitor number, which is shown in test results

printout.
After clicking the box, Reaction monitor number input +
Enter.
Cell No. * By designation of registration number, used reaction cell

number is shown automatically. (1 to 90)
Sample round No. * By designation of registration number, the corresponding

sample round number is shown automatically.
Sample No. * By designation of registration number, the corresponding

sample number is shown automatically
Item No. * By designation of registration number, the corresponding

test item number.
Item Name * By designation of registration number, the corresponding

test item name and test results are shown.
4-43
V5.7
Main wavelength * Used main wavelength display
Cell Blank * Cell blank for main wavelength display
Sub wavelength * Sub-wavelength display
Cell Blank * Cell blank for main wavelength display
No Abs. Display of Main wavelength optical absorbance.
Clicking or button, Main wavelength optical

absorbance result data scrolls and displays in optical
test range.
Test point 1 is cell blank test position.
R1 dispense position: Optical test point 7
S dispense position: Optical test point 8
Mixing position: Optical test point 8
R2 dispense position: Optical test point 36
Mixing position: Optical test point 36
All optical absorbance result are cell blank
subtracted.
No Abs. Display of Sub-wavelength optical absorbance.
No Abs. Display of optical absorbance difference between two

wavelengths.
Clicking check button, switch the graphic

display color. Selected wavelength is shown in
red color.
SPAN * Optical absorbance value of graphic display (Y axis)

Sensitivity setting (-9.999 to 9.999 Abs)
This function is effective if auto-span is not selected.
Clicking this box, Span value + Enter
Zero Level * Optical absorbance value of graphic display (Y axis)

Base point setting (-9.999 to 9.999 Abs)
This function is effective if auto-span is not selected.
Clicking this box, Span value + Enter
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* Auto-Span Clicking this check button, automatic span selection is

active.
Reaction Graph Graphic display with X-axis is test point and Y-axis is
optical absorbance value By the selection of condition
setting, controlled and displayed.
By clicking, displays Reaction monitor of smaller

number than current container number.
By clicking, a graphic display based on the setting

condition, give by condition setting, is shown under
the re-edition.
By clicking, displays Reaction monitor of larger

number than current container number.
Print By clicking, Absorbance data of displayed container

number are printed out.
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V5.7
1. Optical absorbance list external storage
It is possible to store Optical absorbance list outside, by the following

operation.
(1) Press Ctrl + D key simultaneously, when Reaction monitor screen is shown.
(2) The following screen is shown.
Input RC# that you want to save.

Starting # -> Ending #
Output Reaction monitor File screen
(3) Input [Start No. - Stop No.] of RC# to be stored in [Register number].
Output file name can be changed.
Note ; Drive name can not be changed (fixed).

In reaction monitor csv file format C: drive ("C: ¥ BiOLiS_Data ¥") it
will be saved under.
Folder name; C:. ¥ BiOLiS_Data ¥ **** csv
(****) file name that you gave when you save.
(4) Click New button. Reaction monitor file is stored as CSV file.
Click Add button if you want to add data to the file until now.
Clicking Cancel button, Output Reaction monitor file screen is closed.
4-46
4.6 Item parameters
4.6.1 Function
This screen is used for Item parameter analysis condition, depending on each
item, registration and modification. The following selection buttons are appear.
Optical ：Optical test items

Serum info ：Serum information
ISE ： ISE (Na, K, Cl)
HbA1c ： HbA1c items
Calculation ： Calculation items
Detergent ： Washing items
4.6.2 Common test Item parameter screen
Clicking Optical button (Item No.1–77), in Item number pull down menu in Item
parameter screen, Common test item parameter screen first page is shown.
Common test item parameter screen is composed of five pages.
1. Item selection menu screen
Clicking Item and click of Item No., following Item selection menu screen
appears.
Click
Item selection menu screen
Note: The test item names, which are already registered, are shown on the
screen.
This screen is used for the designation of test items, to be register or
modify.
Item No.| This input box is used to select test item number to
register or to modify. Clicking button, test item list is
shown on the screen.
Clicking the number, the number appears in the box and
back color turns to blue.
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V5.7
Item Name Test item name appears in the box if already registered.
For registration of new test item, input tem name into
the box.
Delete Clicking this button, the registered contents of the item

number are deleted from the Item Parameter file.
Prev. Page By clicking, Item parameter screen (Preview Page) is

shown.
Next Page By clicking, Item parameter screen (Next Page) is shown.
Print By clicking, Item parameter is printed. (External preprint)
Save Clicking this button, the contents of the screen are stored in
the Item Parameter file.
Common Item screen (Item No.1~77)

［The 1st page］
Item screen of Linear 1 calibration
Item No.| Test item number, designated in Item selection menu

screen, is shown. (1∼77)
Item Name * Test item name
Clicking the box, input item name + Enter.
Data information
Unit * Unit name of test result(Up to 8 characters)

Clicking this box, Unit to be registered + Enter.
Decimals * Number of digits below decimal point of the test

result (0–3)
After clicking the box, Number of characters + Enter.
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Analysis
Type * Input box of analysis type.(2 kinds: END,RATE)

After clicking box, select desired analysis
type from the pull down menu.
Main Wave Length * Input box of Main-wavelength (12 kinds)

After clicking box, select desired wavelength
from the pull down menu.
Sub Wave Length * Input box of Sub-wavelength (12 kinds) After

clicking box, select desired wavelength from the
pull down menu.
Method Analysis Method Name, message input box.

(Up to 20 letters)
Calibration
Type * Kinds of Calibration (8 kinds)

Default is Factor.
Clicking and select desired Calibration kind
from the list.
In case of Factor
Factor * Input Factor value.
(In case of decrease reaction, minus is necessary
to input.) Factor value input box
If the other than Factor is selected, the following
is shown. (-99999 - 99999)
If the other than Factor is selected as calibration type, input standard sample
concentration.
Blank * “0” concentration, such as physiological saline,

input is necessary.
#1 * After clicking this box,

∼ Concentration value + Enter
#6 * Usable up to 6 samples.
Registration or modification starts from the
younger number.
Concentration setting order also starts from
younger to larger. In case of multiple
calibration, you need to input more than 3
concentration.
Stability * Enter the valid days (1-999) for calibration
curve.
If you do not enter it, the control function of the
valid days will be disabled.
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V5.7
In case of Linear 1 Calibration

It is able to input factor minimum, maximum
and CV (%) max values.
If a test result comes out of Factor or CV (%) range, the “F”

or “CV” error flag is attached in “Cal Data” screen.
Correlation
Slope * Slope of correlation correction (0 - 999.999)

After clicking the box, Number + Enter
Intercept * Intersection of correlation correction

(-999.999 - 999.999)
After clicking the box, Number (including minus) +
Enter.
【 Correction calculation formula Y = Ax + B】
A: Slope (SLOPE) Default = 1.00
B: Intersection (INTER) Default = 0.00
X: Actual test positive results
Y: Corrected final results
Auto Rerun Incident

Input box of relative tests on the auto-rerun.
Set the item to be rerun in association with the
corresponding item at the time of automatic rerun.
Mixing Speed
Select mixing speed of MU1 or MU2.
If you want to use Single reagent, mixing of M2 is not
done.
Note; Set the mixing speed at the time of automatic

dilution in the "System-Sys.Param" screen.
4-50
［The 2nd page］
Aspiration
Kind Single reagent or double reagent selection

Single ◎ Double Select one out of two by clicking one of them.
Black circle appears if selected.
Vol
Sample * Sample dispense volume (1.0 to 20.0micro-liter)
After clicking the box, Number (micro-liter) +Enter
Reagent 1 * Reagent 1 dispense volume (100 to 240 micro-liter)


Rinse vol. Select sample rinse volume.
Reag. vol. * Select reagent bottle volume.

Reagent volume is calculated from the bottle volume.
Default; Reagent 1 (1) 70mL / 70mL
Reagent 2 (2) 20mL / 20mL
Reaction monitor
0 Level Point * Basic test point, which is used for reaction monitor or
graphic display. Default is “0”.
Span * Full scale of reaction monitor graphic display.

(-9.999 to 9.999) Default is “3.0”.
After clicking the box, Span value + Enter
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V5.7
Data process
Read
Start End Stating test point and ending test point of main
Main * * test interval, which is used for test result value
calculation. (Input; 9 to 76, Double reagent; 36~)
1 step is 7.5 seconds.
(Example) Water blank 1 point

R1 dispense 7 point
Sample dispense 8 point
R2 dispense 36 point
Read point end 76 point
Result output 82 point
START≦ END
Start End
Sub * * Stating test point and ending test point of sub
test interval, which is used for test result value
calculation. (9 to 76)
START ≦ END
Abs. limit
Low * Input box for the lower and upper limit of optical
∼ absorbance. (-3.0 – 3.0 Abs)
High * After clicking the box, Number (Abs) + Enter
LOW ≦ HIGH
If calculated variation is out of the designated low
range, “B” flag appears in the result printout.
If out of the high range, “G” flag appears.
Note: As measured optical absorbance, main wavelength is

used for both 2 wavelength measurement and single
wavelength measurement.
And this is cell blank, reagent blank cancelled value.
Correction value
Blank correction * Input box of Blank correction coefficient used for

sample blank correction. (-9.9999 - 9.9999)
K value calculation method

① In case of two reagents system and sub test interval is
before R2 dispense, main test interval is after R2
dispense.
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Sample dispensing volume + R1 dispensing volume

Ｋ＝
Sample dispensing volume + R1 dispensing volume + R2 dispensing volume
※ Inputting sample volume and reagent volume, K

value is calculated automatically.
② 1 reagent system or 2 reagents system having main

and sub test intervals are the same side of R2 dispense.
Ｋ＝1.000
End Point Limit * Limit value to check optical absorbance upper limit,
for END point assay. (-3.0~3.0 Abs)
After clicking the box, Number (Abs) + Enter
If optical absorbance exceeds limit value, within the test
points designated by main interval, “E” mark appears in
result.
Linearity check (%) * Linearity standard value for RATE assay (0~99%)
After clicking the box, Number (%) + Enter
As for calculation method of the number, refer to “Chapter 2,
2.7 Linearity check, Calculation method”.
If calculated linearity exceeds standard value, “L”
mark appears in result.
Prozone check
Prozone phenomenon check parameter input area, for immuno-reaction.

For theoretical explanation of the principle, refer “Chapter2, 2.8Prozone check
function”. If the prozone check is out of the value, “P” flag appears.
Start End
First * ** Starting (*) and ending (**) test points of basic test interval.
(9 – 76) After clicking the box, Number + Enter
Second * ** Starting (*) and ending (**) test points of reference test
interval. (9 – 76) After clicking the box, Number + Enter
Limit (%)
*** Comparison limit value (-99999 - 99999) %
◎High Low Select High or Low by clicking. black circle appears if

selected.
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V5.7
Minimum Abs.
Average *** Enter the minimum absorbance average value of main
wavelength in the first interval. (0~3.0) (Default 3.0)
No Prozone check is done if the average value exceeds the
input value.
Variation *** Enter the absorbance variation of main wavelength in the first
interval per cycle. ( ⊿ OD/cycle) （ 0 ∼ 3.0 ） 1 cycle ＝ 7.5sec
(Default 0)
No Prozone check is done if the slope value exceeds the input
value.
Note: If the set value of the minimum Abs. average and the
variation are “0” or are not set, Prozone check is not
conducted.
［The 3rd page］

Condition setting of normal range and panic range are set in this screen.
Normal range
Input boxes of lower and upper limit of male or female
normal range for various sample kind.
(Serum, urine, plasma, CSF and dialysis)
If the normal range is out of the range, “L” or “H” flag
appears.
Panic range
If panic range is out of the range, “PL” or “PH” flag appears.
Reaction check
Reaction check ON-OFF switch will be established to select
whether to check a reaction absorbance or not. A checkpoint
can be set.
The upper limit and the lower limit of the check range can
4-54
be inputted.
The average of the main wavelength absorbance of three
points centered on the read point you enter will display the
"AB" in the case beyond the setting range.
[Condition of the setting value range]
Check Point : 1 90
LOW: -3.0 - +3.0
HIGH: -3.0 - +3.0
［The 4th page］

The conditions of Auto re-run are set in this page.
Auto rerun SW
ON ◎OFF Auto-rerun selection by clicking On or OFF
If select ON here, you have to do the following settings.
Set Auto-rerun ON in System parameter screen.
Register the diluent to be used in System screen.
If selected OFF, the following settings are ignored and no
rerun.
Auto rerun range（Conc.）

First Dil Input box of dilution ratio, which is applied at the regular
test, before the rerun test. If a ratio is input, the ratio
appears in dilution box of Order entry screen automatically.
Dilution ratio modification is possible in Order entry
screen.
Low（High） Set rerun when the low value and high value are out of the
set value.
Re Value Dil ① Click of “Re” to check.
レ * ** ② Input concentration value for rerun judgment.
③ Clicking button of Dil box and select dilution
ratio(×3, 5, 6, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100)
from the list.
It is available to set each sample kind. (Serum, Urine,
Plasma, CSF, Dialysis, Other)
The dilution ratio would be one (1) automatically, if it is
not selected from the drop-down menu.
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V5.7
Auto rerun condition（Absorbance）

On ◎Off
Lower Select auto-rerun ON or OFF against allowable
Higher optical absorbance range, which is registered in second page
of Item parameter screen.
6 times diluted is used for rerun.
Auto rerun condition（Prozone）
On ◎Off Select auto-rerun ON or OFF against Prozone
allowable range, which is registered in the second
page of Item parameter screen.
The amount of dispend: Set the sample volume at the time of automatic
rerun.
［The 5th page］

Condition setting of concentration result transforms to qualitative result.
Qualitative value
Quantitative result is converted into optional qualitative value.

The conditions (density) and marks (default 2- to 4+, available 5 alphanumeric
characters at most) are input.
The set mark displays in result field.
This value can be set for sample type.
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4.6.3 Serum information
Serum information parameter screen is composed of two pages.

Clicking Serum info button (Item No.96), Serum info parameter screen is shown.
Affect the measurement result. Lipemia(L)･Hemolysis(H)･Bilirubin(I).
Setting change the possible,

"item name", and "bottle capacity" in the amount of liquid - is the
"determination value" (qualitative numerical values in each item of Lipemia,
Hemolysis, Bilirubin).
Lipemia (L); Measures the two wavelengths in the wavelength range of

visible light. (No effect of hemolysis and bilirubin)
Hemolysis (H); Measures the two wavelengths in the medium wavelength
region (No effect of bilirubin). And measure the two
wavelengths in the long wavelength region.
Bilirubin (I); Measures the two wavelengths in the short wavelength region.
And measure two wavelengths of medium and long-wavelength
region.
Parameter is fixed.
Item No.| Item number is 96. Is fixed.
Item Name * Test item name (Max input 8 characters)
［ The 1st page］
Data Information
Decimals * Parameter is fixed.
Wavelength
Item Main Wave- Sub Wave-
Lipemia 660nm 700nm Parameter is fixed.
Hemolysis 570nm 600nm
Bilirubin 450nm 505nm
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V5.7
Correlation
Parameter is fixed.
Aspiration
Parameter is fixed.
Kind ◎ Single Single is fixed.
Vol
Sample * Dispense volume is 16 L.
Reagent 1 * Dispense volume is 144 L.
Reag. vol Bottle vol.
Blank value
Parameter is fixed.
Reaction Monitor
Parameter is fixed.
[The 2nd page］
Calculation Factor Value

Factor values are used to calculate the serum information.
Parameter is fixed.
Data Process
Read Parameter is fixed.
Abs.Limit
Mixing Speed
Parameter is fixed.
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Qualitative value
Quantitative result is converted into optional qualitative value.

The conditions (density) and marks (default 2- to 4+, available 5 alphanumeric
characters at most) are input.
The conditions have been initialized.
※ If there is a decision the difference between serum information by visual, please
adjust by changing the decision value.
The set mark displays in result field.
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V5.7
4.6.4 ISE Item parameter screen
Clicking of ISE button, in ISE item parameter screen first page is shown.
［ ISE Item parameter screen］
Item No.| ISE Item number is shown.

It is fixed at 78-80. Cannot be changed.
Item Name * ISE item name is shown.
［ The 1st page］
Item No.| ISE Item number is shown.
Item Name * Input ISE item name.(Max input 8 characters)

After clicking the box, Item name + Enter
Data information
Units * Input box of unit. Default is mEq/L.
Decimals * Input box number of digits, below decimal point. (0–3)
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Analysis
Type ISE Fixed as ISE.
Method Analysis Method Name display/input (Up to 20 letters)
Correlation

Inter * Intersection of correlation correction

(-999.999 - 999.999)
Enter.
Normal range
Low High
Male * ** Input boxes of lower and upper limit of male or
Female * ** Female normal range for various sample kind.

(Serum, urine, dialysis) If out of range value, flag “L” or “H”
mark appears.
［ The 2nd page］
Auto-rerun setting
OK ◎ Ignore Auto rerun selection by clicking OK or Ignore.

If select OK here, you have to setting Auto-rerun
ON in System parameter screen.
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V5.7
If selected Ignore, the following settings are ignored and no

rerun test.
Auto-rerun setting（conc.）
Low（ High） If you apply auto-rerun, input the condition here.

rerun Value 1. Click a Re input box to register auto-rerun.
レ * 2. Input a criterion for rerun decision into Value box.
ISE test can handle serum, urine and dialysis.
Calibration slope range
Input boxes of lower and upper limit of ISE calibration

range for various sample kind.
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4.6.5 HbA1c parameter screen
Clicking of HbA1c, the Item number 101,102,106, in the Item number pull
down in Item parameter screen, HbA1c parameter screen first page is shown.
Item No.101, 102 The No. 101 and 102 are used for one parameter
methods same as common Items.
(Example : Latex reagent)
Item No.106 The No. 106 is used for two parameters method.
Parameter set Hb and A1c individually.
(Example: Enzymatic method)
1. HbA1c Item number screen

Clicking HbA1c and click of Item No., following HbA1c selection menu screen
appears.
HbA1c test item parameters are composed of four items.
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V5.7
2. HbA1c Item number 101 and 102 screen

HbA1c101, 102 of parameters is made up of 3 pages.
［ The 1st page］
Item No.| When 101 or 102 is selected as item number,

the first page of item parameter screen is shown.
Item Name * Test item name. (Max input 8 characters)Clicking the box,
input item name + Enter.
Data information
Unit * Unit name of test result(Up to 8 characters)

Decimals * Number of digits below decimal point of the test result.
(0–3) Clicking this box, Number of characters + Enter.
Analysis
Type * Input box of analysis type. (2 kinds: END, RATE)

After clicking box, select desired analysis type from
the pull down menu.
Main Wave Length *

Input box of Main-wavelength (12 kinds)
After clicking box, select desired wavelength from
the pull down menu.
Sub Wave Length *

the pull down menu.

(Up to 20 letters)
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Calibration
Type * Kinds of Calibration (8 kinds)

Default is Factor.
Clicking and select desired Calibration kind from
the list.
In case of Factor
(In case of decrease reaction, minus – is necessary to
input.)
Factor value input box
If the other than Factor is selected, the following is
shown. (-99999 - 99999)
concentration.
Blank * “0” concentration, such as physiological saline, input
is necessary.
#1 * After clicking this box, Concentration value + Enter
∼ Usable up to 6 samples.
#6 * Registration or modification starts from the younger
number.
Concentration setting order also starts from younger
to larger. In case of multiple calibration, you need to
input more than 3 concentration.
Stability * Enter the valid days (1-999) of calibration curve. If you do

not enter it, the control function of the valid days will be
disabled.
In case of Linear 1 Calibration
It is able to input factor minimum, maximum and CV (%) max values.

If a test result comes out of Factor or CV (%) range, the “F” or “CV” error flag is
attached in “Cal Data” screen.
Correlation

Intercept * Intersection of correlation correction (-999.999 –
999.999) After clicking the box,
Number (including minus) +Enter.
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V5.7
［ The 2nd page ］
Reaction monitor
0 Level Point * Basic test point, which is used for reaction monitor

(-9.999 to 9.999) Default is “3.0”.
Data process
Read

R1 dispense 7 point
START≦ END
Start End
START ≦ END
Abs. limit
4-66

LOW ≦ HIGH
range, “B” flag appears in the result printout. If out of
the high range, “G” flag appears.

Correction value

(K value)
1. In case of two reagents system and sub test
interval is before R2 dispense, main test interval is
after R2 dispense.

Ｋ＝
*Inputting sample volume and reagent volume, K value
is calculated automatically.
2. 1 reagent system or 2 reagents system having main and

sub test intervals are the same side of R2 dispense.
Ｋ＝ 1.000
End Point Limit * Limit value to check optical absorbance upper limit,
If optical absorbance exceeds limit value, within the
test points designated by main interval, “E” mark
appears in result.
Linearity check (%) *

Linearity standard value for RATE assay (0~99%)
As for calculation method of the number, refer to
“Chapter 2, 2.7 Linearity check, Calculation method”.
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V5.7
Prozone check

For theoretical explanation of the principle, refer “Chapter2 2.2.2 Prozone
check function”. If the prozone check is out of the value, “P” flag appears.
Start End
First * ** Starting (*) and ending (**) test points of basic test
interval. (9 – 76)
Limit (%)
◎ High Low Select High or Low by clicking. black circle appears if

selected.
Minimum Abs.
wavelength in the first interval. (0~3.0) (Default 3.0)
input value.
interval per cycle. ( ⊿ OD/cycle) （ 0 ∼ 3.0 ） 1 cycle ＝ 7.5sec
(Default 0)
value.
conducted.
［ The 3rd page］
4-68
Normal Range

If the normal range is out of the range, “L” or “H”
flag appears.
Panic Range

If panic range is out of the range, “PL” or “PH” flag
appears.
Aspiration
Lysing sample preparation
Lysing Aspi.level ＊ Input aspiration position (mm) from the bottom of
HbA1c primary tube. (1-7mm)
Sample * Sample dispense volume (1.0 to 20.0 micro-liter)

Lysing solu * Lysing solution volume. (100 to 240 micro-liter)

Rinse vol Select sample rinse volume. (20 to 40 micro-liter)

Default is “0”
HbA1c
Single ◎ Double Single reagent or double reagent selection Select one
out of two by clicking one of them.



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V5.7
Rinse vol. Select sample rinse volume. (20 to 40 micro-liter)

Default is “0”

Reagent volume is calculated from the bottle volume.
Mixing speed
MU1・2 * Select mixing speed of MU1 or MU2.（1∼5）

If you want to use Single reagent, mixing of MU2
is not done.
Mixing speed, slow smaller number. (1<5)

3. HbA1c Item number 106 screen

HbA1c106 of parameters is made up of 6 pages.
Condition setting for the first Item.
［ The 1st page for HbA1c No.106］

Input Hb Item parameter screen
Item No.| When 106 is selected as Item number, the first page of
item parameter screen is shown.
Item Name * Test Item name Clicking the box, input Item name + Enter.
Data information
Unit * Unit name of test result (Up to 8 characters)

Decimals * Number of digits below decimal point of the test result.
(0–3)
Clicking this box, Number of characters + Enter.
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Analysis
Type * Input box of analysis type. (2 kinds: END, RATE)

After clicking box, select desired analysis type from
the pull down menu.
Main Wave Length *
the pull down menu.
Sub Wave Length *

the pull down menu.

(Up to 20 letters)
Calibration
Ttpe * Kinds of Calibration (8 kinds)

Default is Factor.
Clicking and select desired Calibration kind from the
list.
In case of Factor
(In case of decrease reaction, minus – is necessary to
input.)
Factor value input box
If the other than Factor is selected, the following is
shown. (-99999 - 99999)
concentration.
Blank * “0” concentration, such as physiological saline, input

is necessary.
#1 * After clicking this box, Concentration value + Enter
∼ Usable up to 6 samples.
#6 * Registration or modification starts from the younger
number.
Concentration setting order also starts from younger
to larger. In case of multiple calibration, you need to
input more than 3 concentration.
Stability * Enter the valid days (1-999) of calibration curve. If you do

not enter it, the control function of the valid days will be
disabled.
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V5.7
Correlation

Intercept * Intersection of correlation correction

(-999.999 - 999.999)
Enter.
［ The 2nd page for HbA1c No.106］

Input Hb Item parameter screen.
Reaction monitor
0 Level Point * Basic test point, which is used for reaction monitor

(-9.999 to 9.999) Default is “3.0”.
Result warrant range
Input warrant range of low and high limit for male and
female.
The B flag shows with result if the result exceeds the
low limit.
The G flag shows with result if the result exceeds the
high limit.
4-72

< Error list display cases >
Data process
Read

R1 dispense 7 point
START≦ END
Start End
START ≦ END
Abs. limit
LOW ≦ HIGH
range, “B” flag appears in the result printout. If out of
the high range, “G” flag appears.

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V5.7
Correction value

(K value)
1. In case of two reagents system and sub test interval
is before R2 dispense, main test interval is after R2
dispense.

Ｋ＝
*Inputting sample volume and reagent volume, K

value is calculated automatically.
2. 1 reagent system or 2 reagents system having

main and sub test intervals are the same side of R2
dispense.
Ｋ＝ 1.000
End Point Limit *

Limit value to check optical absorbance upper limit,
If optical absorbance exceeds limit value, within
the test points designated by main interval, “E”
Linearity check (%) *

Linearity standard value for RATE assay (0~99%)
As for calculation method of the number, refer to
“Chapter 2, 2.7 Linearity check, Calculation method”.
Prozone check
For theoretical explanation of the principle, refer “Chapter2 2.2.2 Prozone
check function”. If the prozone check is out of the value, “P” flag appears.
Start End
First * ** Starting (*) and ending (**) test points of basic test
4-74
Limit (%)
◎ High Low Select High or Low by clicking. black circle appears if

selected.
Minimum Abs.
wavelength in the first interval. (0~3.0)
(Default 3.0)
input value.
interval per cycle. (⊿OD/cycle)（0∼3.0）1 cycle＝7.5se
(Default 0)
value.
conducted.
［ The 3rd page for HbA1c No. 106］

Input A1c Item parameter screen.
※Input method is the same as the item parameters of the first page of Hb.
[The 4 th page for HbA1c No. 106］

Input A1c Item parameter screen.
※Input method is the same as the item parameters of the second page of Hb.
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V5.7
［ The 5th page for HbA1c No. 106］

Setting formula of HbA1c.
Type using the items and Hb A1c.
Computing Method
Item１ * Hb display.
Item２ ** A1c display.
Method *** Input the formula for calculated the HbA1c.
Data Information
Units * Unit name for test result value. (Up to 8 letters)
After clicking the box, Unit to be registered+Enter
Decimals * Number of digits below decimal point for test
result value (0 – 3)
After clicking the box, Number of character+Enter
Computing Method List
New Formula Edit the formula, create a formula list.
[The 66h page for HbA1c No. 106］

Set about analyzing conditions of HbA1c.
Normal Range

If the normal range is out of the range, “L” or “H”
flag appears.
4-76
Panic Range

If panic range is out of the range, “PL” or “PH” flag
appears.
Aspiration
Lysing sample preparation
Lysing Aspi.level ＊ Input aspiration position (mm) from the bottom of
HbA1c primary tube. (1-7mm)
After clicking the box, Number (micro-liter)+Enter

Lysing solu * Lysing solution volume. (100 to 240 micro-liter)

Rinse vol Select sample rinse volume.(20 to 40 micro-liter)

Default is “0”
HbA1c
Single ◎ Double Single reagent or double reagent selection Select one
out of two by clicking one of them.

Reagent 1 * Reagent 1 dispense volume(100 to 240 micro-liter)


Rinse vol. Select sample rinse volume. (20 to 40 micro-liter)

Default is “0”
Reagent volume is calculated from the bottle
volume.
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V5.7
Lysing absorbance check
ON ◎ OFF Select lysing absorbance check ON or OFF.
First、Second
Input read starting point and ending point for the first
and second interval.
Check Value
Input check value against lysing condition optionally.
Calculation of Check Value

[Second interval Abs. average (Main – Sub)] – [First interval Abs. average (Main –
Sub)] ×Blank correction／ A1c result ×100
The AB flag shows with result if the value exceeds the

setting value.
Mixing speed
MU1・2 * Select mixing speed for MU1 and MU2 from 1 to 5.

(The maximum speed set 5)
(Default is 3)

The mixing speed for auto-lysing is set in system
parameter.
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4.6.6 Calculation between Items screen
Clicking Calculation button (Item No.81–95), in Item number pull down

menu in Item parameter screen, Calculation item parameter screen first
page is shown. Calculation item parameter screen composed of two
pages.
Calculation Item screen
Calculation Item screen

screen, is shown. (81∼ 95)
［ The 1st page］

screen, is shown. (81∼ 95)

Clicking the box, Item name + Enter.
Edit Formula From this button, editing computing formula is possible.
Save Clicking this button, Item parameter screen is stored.
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V5.7
Computing Method
After clicking each box, select an item in the Item list and double click it.
Item１ * Item name of Item 1, used in calculation between

items
Item２ ** Item name of Item 2, used in calculation between
items
Item３ *** Item name of Item 3, used in calculation between
items
Method * Input box for Computing formula name.
To input a name, select a desired computing formula in
Computing Method List and double click it. If there are no
formulas in the list, make new formulas by clicking New
Formula and Edit Formula button. Refer to the explanation
in the Edit Formula.
Data Information
Units * Unit name for test result value. (Up to 8 letters)

After clicking the box, Unit to be registered+Enter
Decimals * Number of digits below decimal point for test
result value (0 – 3)
After clicking the box, Number of character+Enter
Item List
1．ＴＰ Item list display, used in calculation between

2．ＡＬＢ Items.
3．Ｔ-CHO Select items used for item 1,item 2 and item 3
by clicking, and double click them.
▼ If there is no item in the list, search it by
clicking or button.
Computing Method List
Item1/Item2 Computing formula list, which is used to select

Item1+Item2 Computing formula name. To input a name, select a desired
New Formula computing formula from this list and double click it. If there
▼ are no formulas here, make new formulas by clicking New
Formula and Edit Formula button.
Edit Formula This box is used to generate a new formula.

Clicking this box, Computing formula edition screen
is shown.
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The method to make a new calculation formula

① Click New Formula in Computing Method List,
in Calculation Items screen.
② Click Edit Formula button.
③ Edit Formula screen is shown.
④ Following to the explanation on the screen, generate a
Edit Formula screen formula at formula input box at the
bottom of the screen.
⑤ Register the formula by clicking OK button.
Registered formula appears in Computing method
list, and screen backs to calculation item screen.
(page 1).
⑥ To stop registration, click Cancel button.
［ The 2nd page］

Condition setting of normal range and panic range are set in
this screen
Normal Range
Input boxes of lower and upper limit of male or
female normal range for various sample kind.
If out of range value, flag “L” or “H” mark appears.
Panic Range
Input boxes of lower and upper limit of male or
female normal range for various sample kind.
If out of range value, flag “PL” or “PH” mark
appears.
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V5.7
4.6.7 Detergent screen
1. Detergent volume setting, dilution bottle setting
Clicking of Detergent button in Item parameter screen, detergent

screen is shown.
1. Set the detergent capacity. Capacity that was set here, probe washing,
the reaction cell washing It is used in the purification.
Settings for each cleaning is done with of "system screen-wash1".
2. A bottle capacity setting of diluent-hemolytic agent.
3. [Bottle set position]
Position1: Acid detergent Position2: Alkaline detergent
(Position3: Diluent R1 only)
Detergent screen
Reagent 1 probe aspiration
Acid : Input Acid detergent volume. (20-240 uL)

ALK : Input Alkaline detergent volume. (20-240 uL)
Reag.Vol : Select bottle volume by clicking
Bottle capacity setting of Diluent and Lysing.
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Reagent 2 probe aspiration
Acid : Input Acid detergent volume. (20-240 uL)

ALK : Input Alkaline detergent volume. (20-240 uL)
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V5.7
4.7 Reagent parameter screen
4.7.1 Function
This is used for the registration of reagent bottle position on the inside and outside,
from No.1 to 71.
Depending on the System parameter setting, residual test display method on the
screen is decided to be test count or residual %.
(If reagent barcode is used, input automatically.) Each item can hold 2 bottles.
Clicking Reagent button, the following bottle parameter screen is shown.
Bottle parameter screen
Click Detergent button. The remaining of Acid, Alkaline

detergents and dilution solution are shown.
ACID; Acidic detergent, ALK; Alkaline detergent,
DIL; Diluent
Detergent remaining screen
Round Name Clicking this button, following dialog box is shown.
Click button
Round definition dialog box
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Round definition dialog box

The Kind of Round Select round number to set. (Up to 10 possible)
Round Name After selecting above the Kind of Round, name for the
kind of round in Round Name.
Save Save the name
Delete Delete the input name.
Return Close the dialog box.
Set Current Round Clicking this button, the shown round name is
Registered as the current round.
For the current round, the back color turns to white,
and the back color is yellow for the not current round.
Reag. remain check This is shown if reagent residual volume confirmation

is set as [Level sensor].
System parameter reagent residual volume
confirmation selection screen
If clicked, reagent probe starts moving and check

level position by down stroke and calculate residual
volume by level detection Display shows % or test
count which calculated by level detection.
Pos. Bottle position number display.

The numbers are the same as the position numbers of the
reagent tray. (R1=No.1~36, R2= No.37~71)
Item The display of the test item name of the set reagent
Test Item registration or modification procedure
① Clicking bottle position which you register or change.
The color of the box turns from white to blue.
② After the selection of test item to be registered or
modified from the item list by clicking, double click it.
If the item to be registered or modified is not in the list
search the item, clicking or button on the right.
③ The Test item is set in the position.
S/D In case of single reagent system, 1 is shown, and

in case of double reagent system, 2 is shown
automatically.
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V5.7
Remain（％） This is shown when reagent residual volume

R1 R2 confirmation in system parameter is set as
“Level sensor”.
In case of “Level sensor”, Reag. remain check button is
shown.
T.Counts This is shown when reagent residual volume

R1 R2 confirmation in system parameter is set as “Count”
or "Level sensor count".
Clicking Fill button, the residual volume of all of
the registered items are shown automatically.
In case of “Count”
Reagent residual volume renewal by volume input
1. Click a position box to be renewal.
2. Press Ctrl key. Test volume input box is shown.
3. Input Volume (ml) + Enter. T. Counts renew
Reagent residual volume renewal by test number input

1. Click T. Count of position to be renewal.
2. Input Test number + Enter . T. Counts renewal.
In case of “Level sensor”, Reag. remain check button is
shown.
Exp.Date Input box of effective date. If analyzer is under barcode

mode, effective date from read barcode is shown
automatically. Date ＋ Enter
Exp.Date(after open) Input box of effective date after open.

If analyzer is under barcode mode, effective date after
open, from read barcode is shown automatically.
Date ＋ Enter
BarcodeＩＤ ID number read by barcode reader or error contents
are shown.
Dual No. When two reagent bottles of the same reagent are set on
the same round, bottle position number of the second
bottle is shown automatically. Maximum 2 bottles are
acceptable.
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Item No. The item number of the reagent is shown here.
Item List Item name list, which is registered in Item parameter

1.UAL (2) file, is shown.
2.CREL(2) Select by clicking test item, which should be set at
3.GOTL(2) desired position, from the list and double click it or by
drug and drop input is possible.
If nothing in the list, search by button.
Alarm * T.count.(%)
This box shows alarm level of short reagent. When
residual test number or residual % reaches this [residual
test volume alarm], the back color of [Alarm T. count]
box becomes to yellow.
Note: [Test stop setting]:which is set in System initial setting

screen.
If residual test number or residual % becomes
[Test stop setting], it turns to red.
FILL This button is shown (in case of test count) screen.

Clicking this button, residual test number of the
selected item is input automatically.
FILL ALL This button is shown (in case of test count) screen.
Clicking this button, residual test number of all items
are input automatically.
Bottle Read When check is in reagent barcode of [Reagent Barcode],

this is shown.
① Clicking the Bottle Read button in the Reagent screen

displays the Reagent Barcode screen.
② Select the reagent bottle positions for reading the
barcodes.
③ Clicking the Bottle Read button in the Bottle read
screen will read the reagent barcode only at the selected
positions.
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Bottle read screen
All Clear By clicking, all the reagent bottle parameters in the

screen are deleted.
Line Clear By clicking, reagent bottle parameters of the

selected position are deleted.
Save By clicking, displayed reagent bottle parameters of

all positions are registered in Bottle parameter file.
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4.8 Calibration screen
4.8.1 Function
This function is used to produce calibration curve.

You can register Sample Numbers of Standard Samples, including Blank
samples, and aspiration repetition number.
You can make Order Entry of Standard Samples.
You also can see Graphic display of optical absorbance of Standard
samples.(Calibration curve)
1. Calibration screen
Click Calibration button, the following calibration screen is shown.
Calibration screen
Round Round name display

Clicking button and select from pull down
menu.
Channel Number display
Order Entry box, by clicking this box

レ mark appears to show that the order is accepted.
(To cancel the order, click the box again.)
Item No Test Item Number display, based on Bottle

１ Parameter information
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Item No The button to call graphic display screen
Graph
Item Name Test Item Name display (upper part), corresponding to the
UAL test item number.
*Lot 001 *Reagent Lot No. is displayed when using reagent barcode.
(lower part)
Blk.Odr. Input box for Blank Sample testing

レ When performing only blank measurement order,
click the box.
So, レ mark appears in the box and the order is
accepted.
To cancel the order, double-click the box with レ .
ReCalc. When re-calculating, chick the square.

レレ mark appears to show that the order is accepted. (To
cancel the order, click the box again.)
S.Rnd The button to call Sample round display screen
Blank Input box for Blank Sample Number and the

B1(**) - 3(*) sampling repetition number Lower line : Display of the
latest optical absorbance data (You can edit these
0.0003(***) data.)
How to input
1. Input “Sample position” into above (**) and press Enter key
2. Input “The number of sampling” into above (*) and press Enter key
3. Input “Absorbance value” into above (***) and press Enter key
Std -1 to 6 Procedure to enter is the same as above.
S1(**) - 3(*) Input box for Standard Sample Number – number of

repetition
0.0005(***) Lower line : Display of the latest optical
absorbance data (You can edit these data.)
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Note : 1. Sample numbers should be arranged in ascending order,

otherwise the warning appears.
If you press Enter key for the wrong input data, “error dialog
box” appears. If this occurs, click OK button and input the
correct sample number.
2. If there are multiple standard samples, and if you modify

Sample Number of STD-1, the sample number of other samples
will be modified to be one larger than the former sample number
automatically.
The latest four test results of the Test Item, which

is selected by cursor, are shown in reverse
chronological order
ex). *3 2015-01-25 0.2179 0.5089
yyyy/mm/dd Blank Abs. STD.1∼6 Abs.
Stability The remaining number of valid days set to the

Calibration Stability of the Item screen is displayed.
Yellow back color indicates one day before the expire
date, and red back color indicates that it is expired.
If an item is measured after its calibration curve was
expired, all results will be marked with "*".
ISE Calibration order box.

ISE calculation; Select 901 or 902 for S.Rnd.
Clicking the box on the left of each item, a check mark
appears in the box to accept the measurement order.
ISE Calibration Data screen To cancel the order, click the box again. The mark
disappears.
Note; ISE calibration(Serum), once every 24 hours, done

automatically.
If you manually perform a serum calibration
measurement, refer to the normal calibration
"Chapter4,11.5 Analyzer maintenance screen -2 ISE
maintenance screen".
Clicking this button, enter orders for all the test items
on this screen except ISE, by one action.
Clicking the button on the left of each item, a check
mark appears in the box. To cancel the order, click the
button again. The mark disappears.
Clicking this button, enter blank orders for all the

test items on this screen by one action.
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Clicking this button, all of ordered items are canceled

except ISE. Clicking the button, a check mark
disappears in the box.
Clicking this button, calibration measurement

results, the following screen is displayed.
The each calibration results are shown.
Note; If it was in the ISE unit operation when click

ISE Cal result button, an error will pop up if an error
has occurred during the calibration measurement.
For more information about the error, refer to "Chapter
6, 6.3 Error number and Message list, 6.5 ISE Error
code list".
Stability screen pops up. The valid date and time of the
calibration curve for each item is displayed.
The following “CalData" screen is displayed for the

calibration measurement results.
CalData screen
(Upper part on the screen)

Date : Select the measurement date.
(Left side on the screen: Optical Item calibration result)
Date Time: The measurement date and time
Test : Test item name
Lot. No : The reagent Lot No. is shown.
(It keeps blank if there is no setting
in reagent screen.)
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Pos. : Measurement sample position

Abs. : The absorbance value will be shown.
(The adopted value will be shown in
multi-aspiration measurement)
Error : Error flag will be shown, if the error
occurs in calibration measurement.
(Right side on the screen: The calibration result is shown
which selected in left side.)
Each measurement results, statistical results (AVG, CV(%),
Max, Min) and Error flag are shown.
: The selected results are deleted.
: The selected results are printed to the

external printer.
: Close the “CalData” screen.
ISE Calibration Data screen
Date Time : The measurement date and time.

Type : Display sample specimen.
(Na, K, Cl)
Slope : Display slope values.
Range : Display of input values which are set
in “Calibration Slope Range” of ISE
Item parameter screen.
Error : Error code will be given.
(000000 is shown without errors)
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This button is used to do re-calculation using

different calibration curve.
In case that measurement of patient sample has
started before the result of calibration has not be
given, the got result is not effective and
measurement has to be redone.
This function is for re-calculating the measured
result of the patient sample using the former
calibration data.
Recalculate as follows.
1. Click check box of recalculating order.
2. Click current displayed absorbance value for
recalculating test item.
3. Calibration history is shown at right bottom of
the calibration screen. By double clicking, select
one absorbance value which is needed
re-calculation from there.
4. Current absorbance changes to above 3 Abs.
5. Clicking Re CAL button, the following dialog box is
shown.
6. Select Normal or QC.

7. Select Start No.(ID）
8. Select END No.(ID）
9． Clicking Start Calculation button, calculation
starts, and the following screen is shown.
Re-calculation is available on the day.
Re-calculation result screen
10. Clicking Save button, the recalculated results

are saved.
The measurement results are updated.
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(Chapter4 4.3 Measurement Result screen)

11. Clicking Exit button, the recalculated results are
not saved, and the results before calculated
remains.
Clicking this button, save the contents that are

displayed
2. Calibration graphics screen
If clicking graph button, graphic screen appears.
Calibration Graphics screen
Item Name * ** Item Name(**) Number(*) display.

Type * Calibration curve type input box/display
Default is the type, which is selected in Item
Parameter screen.
From the pull down menu, you can select other
calibration curve for simulation.
Standard Concentration Absorbance ＊Standard Sample, Blank Sample

Blank * ** concentration display.
Concentration value registered in Item
Parameter screen is shown.
6 * ** ＊＊Standard Sample, Blank Sample test results
display
Test results are shown in optical absorbance.
Slope Measured Factor value

Factor=Standard sample conc./(STD Abs.−BLK Abs.)
If you input Abs value in ** box, corresponding

concentration is shown in the right box *.
You can use Conc. Box as an input box to
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V5.7
generate a new temporal calibration curve, for

simulation purpose.
Lot No. Reagent Lot No. is displayed.

(Only when reading reagent barcode.)
Run Date Calibration measurement date is displayed.
Hard Copy Graphic screen is printed from external printer.
Compute This button is used to generate a new calibration

curve.
If you input new data in ** and *, click this button to
get new calibration curve display.
Note This operation is used only for simulation.

New input data will not be stored.
Exit Clicking this button, the display goes back to

Calibration Parameter screen.
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4.9 System screen
4.9.1 Function
In this System section, the following items are handled:

Registration of control sample measurement timing, confirmation of system
program version, registration of reagent probe and reaction cuvette
carryover protection and so on.
Clicking System button, the following screen is shown.
System program select buttons
Clicking each “System program select button”, the next setting screen is
displayed.
Sys. Param. System parameter registration screen.
Date/Print Date and print condition setting screen.
Wash 1 Reagent probe, reaction cell washing condition

registration screen.
Wash 2 Sample probe washing condition registration screen.
Version System program version information display screen.
Comm. Settings Communication condition setting screen.
Configuration Basic condition setting screen.

To open the screen, password input is necessary.
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4.9.2 System parameter screen
Clicking System button and Sys.Param button, the following screen is shown.
System Parameter Screen
Run sequence area
Unknown Tray For Unknown Tray, the measurement order follows the
◎by sample order of sample number.
Calobration Tray For Calibration Tray, you can select By Sample or By Item.
by sample
◎by Item Default setting is By Item.
by Item : Measure the blank sample for each item and
standard sample in pairs.
by Sample: Measure the blank sample for all the items
before measuring each standard sample.
Control method area

Calibration round Control sample measurement timing selection,using
calibration round. Select None or Last .
None ◎Last Default is Last .
None : If None is selected, no Control Sample is
measured for Calibration round.
Last : If Last is selected, Control Sample is measured
following the measurement of the last sample on
sample round.
R-moni. area
Max * Set test number reaction monitor to save.

Input a number 0 – 9999. Default is 9999.
Control Lock-out
Control Yes ◎No If set as Yes, when a test result of control sample exceeds
2SD, no order entry of the test item is acceptable.
Default is No.
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Initialize Cell No.

No. * Display box for the first Sample Number of the next
measurement. Operator can modify a starting sample
number by inputting a new sample number for the next
run. Click Ready before running.
Reagent remain
◎Count Reagent residual volume display selection.
Level sensor Count : If Count is selected, residual volume is
shown by test count number.
Level sensor : If Level sensor is selected, residual
volume is shown by %.
Warming…
If unable is Measurement is selected, no test run during warm-up.
Default is Measurement enable.
◎Measurement enable; In case “Measurement is unable”, measurement is not.
Measurement is unable; started during warming up.
Auto Rerun
On ◎ off Select whether to execute automatic rerun or not.
This selection has the highest priority. If OFF is
selected here, even if ON is item parameter, no
auto-rerun.
Sample Probe Wash

◎by Item Sample Probe Wash pattern setting.
by sample Only one button is selectable.
by Specimen
System
ISE If you perform ISE measurement, click this box.
Reagent Barcode If you perform Reagent Barcode, click this box.
Clicking the button, Barcode reading button appears in
Reagent screen.
Clot Sensor If you perform check the clogging of the sample probe,
clicking this button.
Mix Speed
During automatic dilution, or make the mixing speed
setting of automatic hemolysis (at the time of HbA1c
measurement).
Set the mixing speed. (1∼5)
The number, the faster the more mixing speed large. to
select by clicking on the button.
After speed set, clicking Save button.
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Save Clicking this button, the parameters on the screen are

saved.
When changed, be sure to click Save button.
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4.9.3 Date / Print screen
Clicking Date/Print button in System screen, the following screen is shown.
Date/Print setting screen
For internal printer

* On If you use internal printer, click a box to put a check
box.
Note; If you check, please operate the equipment in

the Always ON the printer power.
When you make the equipment work with the
printer power OFF, the cause of the
malfunction.
(It will be displayed error when equipment
start-up)
Select printing value

Level Error ◎ Select the style of printout between “value” and
ABS Error “*****”for the Level Error, the ABS Error and the
Multi-CAL Error Multi-CAL Error by clicking Save button
When setting the value, the data are printed out.
When setting *****, ***** is printed out.
Single Report
* Auto print Make the check in the case of performing automatically
patient report printing.
Date Settings
A calendar of the month is shown.
System date is marled in the calendar.
Click a date to change the system date.
Date Format
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V5.7
Date format selection box for PC screen.

Default is yyyy/mm/dd. Click button and select a
format from pull down menu.
Date format selection box for internal printer.

Default is yyyy/mm/dd. Click button and select a
format from pull down menu.
Save Clicking this button, the parameters on the screen are

saved.
When changed, be sure to click Save button.
Note; If you change the setting, please click Save.
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4.9.4 Wash 1 screen
Open System screen and click Wash 1 button, the following screen is shown.
Registration of washing condition for reagent probes and reaction cell are input
here.
Reagent probe wash

To avoid carryover caused by reagent probe, register the carryover effecting test
item, carryover sensitive test item and cleaning solution used to wash reagent
probes for each test item.
※The upper limit of setting registration is 60.
Probe Wash Condition Registration screen
Item 1 Input box of carryover effecting test item.

*
Item 2 Input box of carryover sensitive test item.

*
Detergent Input box of cleaning solution to avoid carryover.

*
Line Delete Clicking this button, data of the selected line are
deleted.
All Delete Clicking this button, all the input data are deleted.
Save Clicking this button, all the data on the screen are
registered.
You can set three conditions for the probe cleaning.

1. In case that only Item 1 is registered, cleaning is performed
after dispensation of the set Item.
2. In case that only Item 2 is registered, cleaning is performed.
before dispensation of the set Item.
3. In case that both Item 1 and Item 2 are registered, cleaning
is performed when the combination of Item 1 and Item 2 occurs.
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Cell Wash
To avoid reagent carryover through reaction cell, register effecting test item and cell
cleaning solutions to be used.
Cell wash condition registration screen
Item Input box of carryover effecting test item.

* If you click an input box, pull down menu appears.
You can select a proper one from the list.
Detergent
* Input box of cleaning solution to avoid carryover.
Clicking button and select a cleaning solution from the
pull down menu.
Line Clear Clicking this button, data of the selected line are
deleted.
All Clear Clicking this button, all the input data are deleted.
Save Clicking this button, all the data on the screen are
registered.
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4.9.5 Wash2 screen
Open System screen and click Wash 2 button, the following Sample Probe
Wash registration screen is shown.
Sample probe wash has 3 kinds of washing “by Item”, “by Sample” and “by
Specimen”. Only one washing kind is selectable.
In case of by Item and by Specimen, set washing condition from Wash 2 screen.
*When by Sample is selected in Sys.Param screen of System screen,
Sample probe washing button is displayed in order screen.
1. Sample Probe Wash (In case of by Item)

If by Item is selected in “Sample probe wash” section, in system parameter screen, the
Sample probe wash (by Item)setting screen
Item 1 Input box of carryover effecting test item.

*
Item 2 Input box of carryover sensitive test item.

*
Detergent Select W1 or W2 to avid carryover.

*
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2. Sample Probe Wash (In case of by Specimen)

If “by Specimen” is selected in Sample probe wash, in System parameter screen, the
Sample Probe Wash (by Specimen)setting screen
Specimen 1 Select carryover effecting specimen.

*
Specimen 2 Select carryover sensitive specimen.

*
Detergent Select W1 or W2 to avid carryover.

*
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3. Sample Probe Wash (In case of by Sample)

When “by Sample” is selected in sample probe wash, in system parameter screen,
Sample probe wash button is shown on order entry screen.
*Only by Sample,
set washing
condition from
order screen.
Click
Sample probe wash
Order entry screen（Sample probe wash, by Sample）
Cliking Sample probe wash button, the following screen is shown.
Sample Probe Wash (by Sample) setting screen
Valid Clicking box, sample probe wash is performed.
Timing Select sample probe wash timing by clicking one of

3 lines.
◎ Before sampling
After sampling
Before and After
Wash bottle position Select cleaning solution cup position ACID or ALK
◎ ACID on a sample tray by clicking one.
ALK
Exit Click Exit button to return to order entry screen.
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4.9.6 Version information screen
Clicking Version button in the System Menu, the following Version

Information screen appears.
Version information screen
User Interface; System program version number and date are shown.
Sequence Control; Control program version number and date are shown.
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4.9.7 Communication setting screen
Clicking Comm.Settings button in system screen, the following screen is shown.

Standard setting is already set. Communication between Host computer and
instrument PC are two types.
Host: Host communication is selected serial communication (RS-232C) or LAN.

The test order comes from the Host. The test results return to the Host.
LAN: The test results in LAN communication are transferred to the Host after
measurement complete.
Communication setting screen
Host
Communuication
◎On Off Using the bi-directional communication of ASTM,
click ON. Default is Off.
Request
◎ All Appoint Select All or Appoint by clicking input box of
[Request] area.
Default is Appoint.
All : Analyzer asks test orders of whole samples to host

computer, once before start tests.
The sample mode is able to use both
Sample round No. and Sample barcode.
The orders are received by clicking request button
in Order screen before start.
Appoint: Analyzer reads sample barcode and asks test order

to host computer, one by one.
The sample mode is used Sample barcode.
Communication type Serial

◎Serial LAN Select communication type Serial.
Comm.Parameter Clicking this button, the following screen is shown.

Host Online Parameter setting screen.
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V5.7
Host Online Parameter screen(Serial)
Port No. ：Port number used for communication.

Select one from Com 1 to Com 9 clicking
a circle.
Baud Rate ：Communication speed selection.
Select Baud Rate from 1200, 2400,
9600, 14400, 19200bps.
Data Bit ：Data bit selection by clicking a circle of 5,
6, 7, 8.
Parity Bit ：Parity bit selection by clicking a circle of
None, EVEN, ODD.
Stop Bit ：Stop bit selection by clicking a circle of 1,
1.5, 2
The default settings are 9600, 8, None and 1.
OK Clicking this button, the parameters on the screen are

saved.
When changed, be sure to click OK button.
Cancel Clicking this button, the display goes back to the

communication setting screen.
Communication type LAN

Serial ◎LAN Select communication type LAN.
Comm.Parameter Clicking this button, the following screen is shown.
Host Online Parameter screen(LAN)
Host IPv4 Address ： Set IP address (IPv4) between the HOST.
Host Port ： Set port number of waiting in the Host.

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OK Clicking this button, the parameters on the screen are saved.

When changed, be sure to click OK button.
Cancel Clicking this button, the display goes back to the

communication setting screen.
Note: The IP Address set in control panel for the

Instrument PC.
Reaction Info.
It is able to select from Sample No. Barcode and Patient ID to

display at the Sample ID in Routine Menu screen of
R-monitor.
Routine Menu screen of R-monitor.
Sample ID mode
Register the measurement order of samples, selecting the sample number or ID

number. Default is sample number（by Sample No）.
◎ by Sample No
lf this button is selected, a sample is identified by the position
number on a sample tray.
by Sample ID >>
lf this button is selected, a sample is identified by barcode.
Clicking >> button in Sample ID mode area, register End
barcode within 16 characters and click OK button.
If you do not use End barcode, skip this step.
End barcode setting screen
lf this button is selected, Host communication is set On.
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V5.7
The test order is send from the Host.
Re-run inputted ID
ON ◎ OFF
When "by sample ID" setting, perform the operation setting
of the time bar code reading failure.
LAN (Result send)
Result is sent by LAN communication. IP address of PC should be set in host

computer. The protocol is use TCP/IP.
Communication
ON ◎OFF Communication is connected when ON is selected.
TCP receive port Default is 3010.

Send port Default is 3011.
Delimit character Define delimiter for communication sentence.

Default is ”, ” comma.
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4.9.8 Initial setting screen
Click the "Configuration" button in the System screen, initial setting screen is
displayed.
The Configuration screen is initial setting. This screen is protected by password.
Initial setting screen
Sample barcode
Set if you want to use the sample barcode.
Cell blank check
Set the cell blank check value.

Default;
Level 1=− 0.5, Level 2= 0.25, Level 3= 0.33
Lamp
Display the remaining usage time after lamp

replacement.
Set the lamp life (time).
Set the time you want to display the alarm.
Specimen(Default setting of ordering)
Specify the type specimen default display of

specimen reception screen.
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Language select
Specify the language display.
Reagent remain
Enter the reagent remaining test numbers to

measurement stop.
This is valid only if it is set to count.
Calibration
Enter the allowable range of the calibration curve

changes.
If you are out of the change acceptable range, and
displays error.
Cell Skip
Set the cell skip
Clot sensor Check Limit
Display the sensor judgment limit.

Please do not change.
Internal printer
Select to print setting for internal printer.

(Sample ID & Name or Patient ID & Name)
Item parameter print
Select the printer for print out of item

parameter.
AUTO START
Set the automatic operation after system power ON.
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Note; In case you have selected the "ON",

Click the AUTO START button on the maintenance
screen, please set the automatic operation.
Refer to “Chapter 4 4.11.3 maintenance list screen,
AUTO START”.
PC power, please 24 hours ON.
However, at least once a week, please restart the
computer power.
Set the motor parameters.

Do not change the settings.
Setting the surplus amount.
Save the setting.
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4.10 Simple operation screen
4.10.1 Function
Analyzer has Simple operation mode. Using this mode, operator can run analyzer
easily.
Refer to “Chapter3, 3.2 Routine operation and “Chapter3, 3.6 Simple operation
mode”
By the above operation, analyzer starts under simple operation mode.

Refer to “Chapter 4, 4.12 Log Off, Log In screen”.
Sample round
Item No.
Profile Name
Item Name
Sample No.
Result
Simple operation mode screen
Sample round Sample round number 991 is shown.(991~999)

Same positions are available to use more than once by clicking
round arrows.
Order Select a Profile name out of Easy 1 to Easy 8.

As each Profile has own group of test items, select a proper one
which includes necessary test items.
As each Profile has own sample positions, set the sample at the
sample position, which belongs to the selected Profile.
*Sample number and sample position on a tray is closely related.

Therefore sample number is decided after sample cup is set on a
tray.
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The relation is followings:

Sample number 1 is the identical sample unit position 1.
Profile 1 : Sample position 1 – 9
Profile Name Profile names are displayed.
Sample position Therefore sample number is decided after sample cup is set on a
tray.
*Only one test is done under the same Sample round and sample
position.
*If you want to use the same sample position again, please
change Sample round. Sample round of Simple operation mode
are 991 to 999.
Color of registered position changes depending on the test stage.
Order : Button keeps pushed state

RUN : Gray
Complete: Blue
Error1 : Red
Item Name Item names of profiles are displayed.
Result Clicking arrow buttons, results are displayed.

Item name, results, unit and error message are shown.
Ready Clicking this button, instrument is initialized.
Start Clicking this button, start measurement.
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V5.7
4.11 Maintenance screen
4.11.1 Function
This function is used for daily maintenance, such as cell blank check,
lamp life check, ISE information and error list confirmation.
Clicking Maintenance button, the following Maintenance screen is shown.
Maintenance screen
Maintenance list
Maintenance list Daily maintenance list for user is shown.
AUTO START This is the screen to set the automatic operation contents at the
start-up.
Note; AUTO START(system Configuration screen) is set to

"ON".
After you restart the system(program), automatic
start-up button is shown.
You can set the start time and operation details.
Monitor This is the screen that monitors display the device status.
File Maintenance
Profile This button is clicked when Profile registration is necessary.
Samp. File This button is clicked when test results are stored in an
external memory.
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Item File This button is clicked when item parameters are stored
in external memory.
QC File This button is clicked when QC data are stored in an

external memory.
ProFile for simple operation

This button is clicked to register an Easy operation profile.
Maintenance
User Maint Click this button to do such as reaction cell washing,

sample probe washing and auto gain.
ISE ISE maintenance screen.
Cell Check The latest cell blank value list is displayed. Check
LAMP Residual lamp life is displayed.
Error List Occurred error list is displayed.
Result Log Test result log list is displayed.
Print Order Print order list is displayed.
Water Blank Water blank list is displayed.
Cell Skip Cell skip list is displayed.
Service maintenance
This function is only available login by Service engineer level.
Temp Set “temperature monitor display”, “temperature setting”

for reaction tray and “temperature control parameter”
from this screen.
M. Function Movement check of each unit by manual function
Reagent Barcode setting

Reagent barcode setting screen.
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4.11.3 Maintenance list screen
1. Maintenance list
Click Maintenance list button, the following maintenance list screen is shown.
The maintenance list for Daily, Weekly, Monthly and every 6 months are made
in the screen. The conditions of the maintenance are checked by check box and
updated date.
Daily maintenance screen

1. Open by double-clicking the Maintenance part, input the procedure.
2. Check the check box ( レ ) after maintenance, and click OK button.
Updated the previous date.
Note; If the date is not updated within each period, the background color of related
button is change to yellow.
2. Auto stert
The auto-start procedures (washing, calibration etc.) are possible to set after
auto-start up.
※Refer to "Chapter 4, 4.13 Timer setting for automatic start-up".
Click AUTO START button, the procedure input screen is shown.
Note ; The procedure is not performed

if the time is set before system
power ON.
Note；
Before setting of the ISE calibration,
two kinds of settings are essential.
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Note ; Before setting of the ISE calibration;

1.Click System and Sys.Para button, check the ISE check box レ in
parameter screen . (Validate the ISE)
2.Click System and Configuration "Motor Param. menu" button,
select the “ISE” in ”Stop position setting”.
Set the value of auto-calibration interval to “0”. The default value
is “24”.
1. Set the procedure by checking the box. (レ )

※The default setting is selected for all the procedures.
※Click All button, the display changed to “All selected” or “All
delete”.
※The ISE calibration is unable to set for individual weekly days.
2. The procedure sequence performs from the upper line. Change the
procedure sequence if necessary.
<How to change the order of operation>
(1) Select the procedure by clicking check box. The back color of the
procedure is changed to blue.
(2) Click or button, the selected procedure moves to up or down.
Set the procedure sequence from the top.
The ISE calibration is unable to change the sequence.
The ISE calibration is measured at first.
3. Set the start time by clicking or button.
When check the All button, the same time are set to all the procedures for
every weekly days include Saturday and Sunday.
4. Click Save, update the setting.
5. Click Exit, close the screen.
6. The analyzer OFF and ON should be done to reflect the setting.
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V5.7
3. Monitor
Clicking Monitor button in Maintenance screen, the following screen is
shown.
This is the screen that monitors display the device status.
Monitor screen
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4.11.4 File maintenance screen
1. ProFile
Clicking ProFile button in Maintenance screen, the following screen is
shown. Register set items in this screen to display in Order entry screen.
Message guide
Test Item list
ProFile setting screen
Number Profile number input box. Clicking button,

registered profile list is shown.
Profile Name *
Profile name input box. (Up to 10 characters)
To change the profile name, click this box and delete
the old name by BS or Delete key, then input
a new name.
Round Round number input box.

Clicking button and select a round.
Message guide Help message display.
Test Item list Test Item selection area

Clicking the box, check mark appears in this box.
Click all the boxes of Test Items to register for the
Profile.
To cancel the Test Item, click the box again.
Add Add profile registrations.
Delete Clicking the button, the displayed profile is deleted.
Save Clicking the button, the profile is registered and stored.
Exit Clicking this button, the display returns to the

Maintenance screen.
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V5.7
2. Sample File
This screen is used to transfer test result file to output memory.

Clicking Maintenance button and Sample File button on File Menu
screen, the following Sample File screen appears.
Sample file screen
Current A date list, which Hard Disk has test results.

Sample file
External A date List, which external memories has test

Sample file results.
Save ->> This button is used to store the test results from
Hard disk to USB or other external memories.
Select the date by clicking in Current Sample File,
and click this button.
<<- Read This button is used to store the test results from
USB or other memories to Hard disk.
Select the date by clicking in External Sample File,
and click this button.
Delete This button is used to delete the test results from

Hard Disk.
Select the date by clicking in Current Sample File or,
External Sample File and click this button.
C: Specify the destination to save by click button.

C:¥ Use CD-RW when you specify CD drive.

Maintenance screen.
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3. Item File
This screen is used to transfer Item parameter file to external memory.

Clicking Maintenance button and Item File button on File Menu screen, the
following Item File screen appears.
Item File screen
Current Item A date list, which Hard Disk has Item file.
file
External Item
A date List, which USB has Item file.
file
Save ->> This button is used to store the QC file from Hard
Disk to USB or other external memories.
Select the date by clicking in Current QC File, and
click this button.
<<- Read This button is used to store the Item file from
USB or other external memories to Hard Disk.
Select the date by clicking in External Item, File and
click this button.
Delete This button is used to delete the Item File from

Hard Disk.
Select the date by clicking in Current Item File or
External Item File and click this button.


Maintenance screen.
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V5.7
4. QC File
This screen is used to transfer QC data to external memory.

Clicking Maintenance button and QC File button on File Menu screen, the
following QC File screen appears.
QC file screen
Current A date list, which Hard Disk has QC file.

Sample file
Extrnal
A date List, which USB has QC file.
Sample File
Save ->> This button is used to store the QC file from Hard
Disk to USB or other external memories.
Select the date by clicking in Current QC File, and
click this button.
<<- Read This button is used to store the QC file from

USB or other external memories to Hard disk
Select the date by clicking in External QC File, and
click this button.
Delete This button is used to delete the QC File from

Hard Disk.
Select the date by clicking in Current QC File or,
External QC File and click this button.


Maintenance screen.
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5. Profile for Simple operation
Clicking Maintenance button and ProFile for Simple operation button, the following
screen is shown.
Message guide
Test Item selection area
ProFile for Simple operation screen
Number Profile number input box. Clicking button,

registered profile list is shown.
Profile Name *
Profile name input box.(Up to 10 characters)
To change the profile name, click this box and delete
the old name by BS or Delete key, then input
a new name.
Round Round number input box.
Message guide Help message display
Test Item list Test Item selection area Clicking the box, check mark
appears in this box.
Click all the boxes of Test Items to register for the
Profile.
To cancel the Test Item, click the box again.
Save Clicking the button, the profile is registered and stored.

Maintenance screen.
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V5.7
4.11.5 Analyzer maintenance screen
1. User Maintenance
Clicking Maintenance button and User Maint button, the following user
maintenance screen is shown.
Note ; It does not work with the device is not ready.
Message guide
User maintenance screen
Message guide Help message display
Cell Washing Clicking this button, all of 90 reaction cuvettes are

washed.
Cell Drain Clicking this button, all the reaction cuvettes are
drained.
PRIM Clicking this button, all the filling lines are filled with
water.
It is convenient to use this function at the system
set up or the piping tubes exchange.
Fill Cell Clicking this button, 240 micro-liter of purified water

or cleaning solution is dispensed into all of 90 reaction
cuvettes.
Before clicking the button, set the bottle with purified
water or cleaning solution in it to R1 side of the
position No.1 on the reagent tray.
Probe Wash Clicking this button, each probe washing is performed.

（ Sample probe, Reagent 1 and 2 probe)
Wash time is about 7 minutes.
Set Alkaline detergent in each detergent position
(No. 2) for sample ,R1,and R2 before clicking the button.
The reagent probe aspirate 240uL of the detergent and
the sample probe aspirates 25uL of the detergent.
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Stirrer Wash Clicking this button, the stirrer washing is performed.

Wash time is about 3 minutes.
All Wash The washing is continued Probe wash Cell wash

Mixing stirrer automatically. (about 15 minutes.)
1. Set Alkaline detergent in each detergent position
(No. 2) for sample ,R1,and R2 before clicking the
button.
2. The reagent probe aspirate 240uL of the detergent
and the sample probe aspirates 25uL of the detergent.
Special wash 1 90 cells are washed in the same procedure as normal

Special wash 2 measurement. (about 26 minutes)
Special wash 1;
Set the detergent bottles to the position 1 (Acid 30%)
before start the washing.
Special wash 2;
Set the detergent bottles to the position 2 (Alkaline 15%)
before start the washing.
Note; Special wash is recommended after measurement once a

day. The detergent needs to be selected according to the type
which is going to be washed.
Metallic contamination: Use 30% diluted solution of Acid

detergent 5D.
Protein contamination: Use 15% diluted solution of Alkaline
detergent 2.5D.
Stop Clicking this button, the abovementioned operations are

immediately stopped.
Exit Clicking this button, the display goes back to the

maintenance screen.
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V5.7
2. ISE
Clicking Maintenance button, ISE button and Electrode button, the

following screen appears.
Electrode Area screen
Current Date Date display
Electrode Clicking Electrode button, the following screen is

shown. Electrode Area
Reference & Pump Tube

Clicking Reference & Pump Tube button, the Reference
and Pump tube screen is shown.
Reagent Clicking Reagent button, the reagent screen is shown.
Maintenance Clicking Maintenance button, the maintenance screen

is shown.
Update Set Clicking this button, the data are renewed.

Maintenance screen.
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Electrode area
Clicking Maintenance button, ISE button and Electrode button, the following
screen is shown.
Electrode Area screen

days is Left
Alarm D Input box for the residual days to be alarmed.
_/183 days is Left
Count Input box for the residual test count to be alarmed.

Alarm This residual life can be over-written by inputting
_/10000 a number.
Change This Residual life display switching box.

Clicking this box, the field of Count to show the
residual test count becomes effective.
Status Graph display of used days/test count, which is

smaller.
Changed Date Electrode replacement date is changed by this

function.
Select a date in the calendar, then click this button.
Reference & Pump tube area

Clicking Maintenance button, ISE button and Reference & Pump Tube
button, the following screen is shown. Reference & Pump Tube Area
Reference & Pump tube screen

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V5.7
[Reference]
days is Left Input box for the residual days to be alarmed.
Alarm D
_/365 days is Left
Count Input box for the residual test count to be alarmed.

Alarm This residual life can be over-written by inputting a
_/10000 number.
[Pump Tube]
days is Left Input box for the residual days to be alarmed.
Alarm D
_/90 days is Left
Change This Residual life display switching box.

Clicking this box, the field of Count to show the
residual test count becomes effective.
Status Graph display of used days/test numbers, which

is smaller.
Changed Date Electrode replacement date is changed by this

function.
Reagent area
Open Maintenance button and click ISE button and Reagent button, the
following screen is shown for Cal 1 and Cal 2.
Reagent area screen
[Reagent 1]
Alarm T Input box for the residual test numbers to be alarmed.
_/ 1321 Residual test numbers display.
This residual test count can be over-written by
inputting a number.
[Reagent 2]
Alarm T Input box for the residual test numbers to be alarmed.
_/ 40 Residual test numbers display.
This residual test count can be over-written by
inputting a number.
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Bottle
ml Input box of Cal-A bottle volume.
Change This Clicking this button, the display of bottle volume

becomes effective.
Status Graph display of used days/test numbers, which is

smaller.
Changed Date Electrode replacement date is changed by this function.

Maintenance
Clicking ISE button.
Clicking Maintenance button, the following screen appears.
ISE maintenance screen
This screen is used to discharge the liquid in the tubes and electrode,
or to fill them with liquid when you exchange electrodes or Cal-1,
Cal 2 or pump tubes.
ISEWash This button is used for ISE wash to clean up the ISE
unit. Set a sample cup contain with 500 uL
ISE wash solution. Clicking this button, ISE wash will
start.
Maint mode This button is used for maintenance mode.
Maint cancel This button is used to cancel the maintenance

mode.
Purge Clicking this button, Cal-1 is sent to the electrode

after the liquid is discharged from the electrode.
At the exchange of electrode or pump tube, this is
used to fill the electrode or tube with Cal-1.
Calibration This button is used for serum calibration

measurement.
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V5.7
Calib. result This button is used for display of serum calibration

results. The slope and AD values will display at the
bottom.
U-Calib This button is used for urine calibration

measurement.
U-Cal result This button is used for display of urine calibration
results. The slope and AD value will display in the
bottom list.
ROM Version This button is used to display the ROM version.

Flow sensor Clicking this button, AD value of flow sensors are
displayed.
Level info. Clicking this button, AD value at Cal 1, Cal 2 and

sample levels are displayed
Initialize This button is used to initialize the ISE unit.
Multiple measure This button is used to multiple measurement.
Maintenance command This button is used to maintenance individual

behavior.
When click the Calib. result or U-cal result, to

display the slope and the AD value.
Click on the flow sensor, to display the sensor level

(air, liquid).
Liquid feeding time and pump speed display.

Normal average liquid feeding time period is from 2.0
to 3.6.
Position Setting This button is used to set the ISE probe position.
Close Clicking this button, the display goes back to the

ISE menu screen.
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1. ISE wash
Sample tray of C, E30 is done by setting the ISE cleaning solution.
ISE wash start screen ISE wash completed screen
2.Maintenance mode start and close

ISE discharge the liquid in the unit.
Maintenance start screen Maintenance ready screen

(Maintenance mode close) ISE unit is filled with Cal 1.
Maintenance closing screen Maintenance closed screen
3.Purge
Purge continue screen Purge completed screen
4.Calibration
Serum calibration measuring Serum calibration completed

screen screen
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V5.7
5.Calib. result (Serum calibration result display)
Serum calibration result Serum calibration result screen

request screen
6. U-Calib.(Urine calibration)
Urine calibration measuring Urine calilbraiton completed

screen screen
7.U-Cal result (Urine calibration result)
Urine calibration result Urine calibration result

screen screen
8. Rom version
ROM version request screen ROM version screen
9. Flow sensor
Flow sensor value request Flow senseor value screen

screen
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10. Liquid Info. (Liquid level sensor)

This button is used to liquid surface information display.
In advance, put the purified water to the sample cup, and then set to C, E1 position.
Result: 10 ・・・Liquid surface normal detection.
Result: 00 ・・・Liquid level detection disabled.
Note ; After the liquid surface check, please be sure to return the nozzle position.
(Please initialization)
Liquid level request screen Liquid level completed screen
11. Initialize (Initialization of nozzle position)

This button is used to position initialization, perform the initialization
operation of the ISE probe position.
Nozzle position setting Nozzle position setting completed

screen screen
12. Multiple measure

This button is used to maintenance individual behavior.
① ② ③ ④ ⑤
⑦ ⑧
⑥ ⑨ ⑩ ⑪
1. No. display.
2. Measured value display.
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V5.7
3. Display of AD value of the specimen.

4. AD value display of calibration 1.
5. Display of error contents. (000000 is normal)
6. Display of results. (Mean, SD, CV)
7. Select of the specimen type.
8. Input of the number of measurements.(1~15 times)
9. Start the measurement.
10. Stop the measurement operation.
11. Close the continuous measurement screen.
Continuous measurement method

1. Setting the specimen type and number of measurements (1-15 times)by multiple
measure screen.
2. Click Start button.
3. Setting the specimen to No.1 and then click Yes button.
13. Maintenance command

This button is used to maintenance operation of the ISE.
Maintenance command screen
Sending Cal 1 Liquid feeding by calibration solution 1.

Sending Cal 2 Liquid feeding by calibration solution 2.
※ After the liquid feed end calibration solution 2, the liquid
feed screen of calibration solution 1 is displayed.
Then click OK button.
Drain in electrode Liquid drainage.
※ After drainage the end of the electrodes, because
the liquid feed screen of calibration solution 1 is
displayed.
Click OK button to make the liquid feed
calibration solution 1.
Note; If you liquid drainage, please be sure to

liquid feed. Because, the electrode is dry
error occurs.
Drain in pot Drainage of the pot part.
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3. Cell Check
This screen shows current reaction cell blank data, of various wavelengths.
Cell blank data are taken during the test.
Clicking Maintenance button and Cell Check button, the following

screen appears.
Cell check screen
When the cell blank value exceeded the check value, boxes will be colored.
Please follow the indication on the bottom.
Refer to Chapter 5.5.2.4 Maintenance for Cuvette replacement.
Level1 -0.500 Check value of cell blank is shown

. The set value is 0.005 (Abs.) and it is not possible to change
this value.
If the value becomes upper than the set value, perform gain
adjustment because it is too light.
Level2 0.2500 Check value of cell blank is shown.

The set value is 0.25 (Abs.) and it is not possible to
change this value.
If the value becomes lower than the set value, it shows
the time for exchange is coming soon.
Level3 0.3500 Check value of cell blank is shown.

The set value is 0.35 (Abs.) and it is not possible to
change this value.
If the value becomes lower than the set value, change
the cuvette into new one.
Note; Each cell level check value, it is possible to be

set in the "cell blank check" of
System-Configuration screen.
Cell skip decision value use the cell level check
value.
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V5.7
Cell number display. (1 - 90)

The latest Water Blank Optical Absorption Value is
displayed for all wavelength.
Stop Clicking this button, will stop the cell check operation.
Save Clicking this button, will save the cell check value.
Start Clicking this button, will start a cell check operation.
You cannot click if you do not in the ready state.
Close Clicking this button, the display goes back to the
Maintenance screen.
Note : When any box lights up in red, it is about the time for all cuvettes to
be exchanged.
Please exchange all of 90 cuvettes at once.
4-140
4. LAMP
It is a measure of lamp life.

When personal computer is ON LINE, lamp life will count down.
Clicking Maintenance button and Lamp button, the following screen

Appears.
The lamp is getting dark gradually with the lapse of time. It also has
reduced display%.
Lamp screen
Change Click this button when you replaced a lamp.

Clicking this, the following dialog box is shown.
When clicking OK button, 100% is shown for the

residual available time, and the display of lamp is
shown light.（ 1200H=100%）

Maintenance screen.
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V5.7
5. Error List Screen
Display the error that has occurred.

Clicking Maintenance button and Error list button, the following screen
appears.
Error List Screen
In this screen, one error is shown in one line.

Scrolling up/down, using scroll bar, can see the hidden part.
[Date Time] Shows date and time, which the error occurred.
[Error] Shows error number of Help list.
[Unit No.] Shows the unit number of the error.
[Error No.] Shows error number.
[Function No.] Shows the code number of unit movement.
[Sample No.] Shows the sample number.
[Item Name] Shows Test item name which the error occurred.
[Detail No.] Shows detail number.
[Message] Shows the message.
[Comment] Shows the comment.
Exit Clicking the button, the display goes back to the

Maintenance screen.
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6. Result Log
Display the measurement results.

This screen is used to confirm former test results.
※ Result Log screen to display the result of the current month worth of
the past three months.
Clicking Maintenance button and Result Log button, the following

screen appears.
Result Log screen
Starting date Input box of starting date.

Stopping date Input box of stopping date.
Clicking button, select from pull down menu.
Sample kind Sample kind selection by clicking a box.

Multiple kind selection is possible.
* All All samples

* Normal Patient sample only
* Standard sample Standard sample only
* QC sample Control sample only
* Blank sample Blank sample only
Search Input date range and sample kind, and click

this button to show results list.
Item Test item selection button and item display box.

This button is used to check test results of one test
item of interest.
Clicking this button, test item list is shown
Item select screen
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V5.7
Select an item by clicking and click Select maker button.

Selected item name is shown in item display box.
[Date/Title] Tested date and time.

Display the results in the measured order. (New data is
displayed on the top)
[S-RND_No.] Display the sample round No.
[Barcode_ID] Display the Barcode ID.
[SAMP_No.] Display the sample No.
[R-mon No.] Display the Reaction monitor number
[Type] Display the Sample kind
[Test] Display the Test item name
[Blank] Optical absorption of blank sample
[Abs./slope] Optical absorption of other than blank sample
[Result] Display the Test result
[Error] Error code or data message
[Dil.] Dilution ratio is displayed.
Add line * Print line selection button and input box of line
range to be printed.
For example, if you want to print lines 1 to 10 and

21 to 30, input as 1-10, 21-30
CSV Outputs the result log that was displayed as a CSV file.
Print Print the data of lines, selected above.

※ You can set the header part of the print.
<Set of header>
1. Open the data list of measurement results screen.
2. Open the Report and Header / Footer, you want to set.
Regardless of the setting, Name column is printed with the
Result Log.
Exit Clicking this button, screen backs to Maintenance screen.
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7. Clot Sensor
The sample probe is checked the clot. The clot sensor error will display when the
result value is above
The check level is fixed in the program.
The checking is done on the analyzer status is [Ready] and [Run].
The sampling is to stopping automatically after automatic washing when the clot
sensor value is above.
Clicking Maintenance button and Clot Sensor button, the following screen appears.
Clot sensor screen
Date/Time Display date and time
Result value Display check results.
Mean Display average.
Close Clicking the button, the screen goes back to Maintenance menu
screen.
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V5.7
8. Auto-gain
Clicking Maintenance button and Auto-gain button, the following screen

appears. The water blank AD values of all the cells are displayed of each
wavelength.
Auto-gain screen
Cell No. Display reaction cell number. [1-90]
Wavelength Display auto-gain values of each wave length.

[340 – 800 nm] Auto-gain range 28000-54000．
Start Clicking this button, the measurement of water blank

will start when analyzer is ready.
Save Clicking this button, the measurement results will
be stored.
Stop Clicking this button, the water blank measurement will

stop.
Close Clicking the button, the screen goes back to Maintenance

menu screen.
Note ; After lamp replacement and cell replacement, please be sure to

Auto-Gain. After Auto-Gain is performed a cell check measurement.
When the Auto-Gain value is out, cell check value will display an
error.
If the measurement without the Auto-Gain, error message is shown.
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9. Cell Skip
Display the Absorbance values of cell skip. (No.1-90)

The skip level is used the values in cell check screen. Cell blank check
value is set in the System-Configuration screen.
Cell skip setting is done in the System-Configuration screen.
Clicking Maintenance button and Cell Skip button, the following screen
appears.
Cell skip screen
When the value exceeded the cell skip value, Abs. box will be colored.
Abs.box is yellow, when the value exceeded one time.
Abs.box is red, when the value exceeded two times. And then the cell is not used for
the measurement.
Skip the cell, the cell check value is not used to measure until the normal
value.
Cell No. Display cell number (No.1-90)
Abs. The result value of cell skip.
Yellow: The value exceeded one time.
Red : The value exceeded continues two times.
The red color keeps Until the value change
to normal after operation of cell check.
Note ; When the cell skip is greater than 20 cell, it will display a warning.
Refer to "Chapter 6 Check flag・Alarm function".
Close Clicking the button, the screen goes back to maintenance

menu screen.
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V5.7
4.11.6 Service engineer maintenance screen
This function is only available login by Service engineer level.

Please refer to Service Manual for more information.
Reagent Barcode setting

Reagent barcode settings, refer to the separate "Reagent barcode manual".
4-148
4.12 Log Off, Log In screen
There are 4 kinds of priority levels in operation.

To change priority level, user name and password input are necessary.
Analyzer judges user level from the input data, and starts analyzer under proper
priority level.
Priority level
1. Operator level: No result edit, item parameter edit and service
button operation.
2. Manager level: All modification, operation and edition are
possible except service button operation.
3. Service engineer level: All modification, operation and edition are
possible.
4. Simple operation level: Simple operation mode only.
Priority level switching

Click Exit button in, Program stop confirmation dialog box is shown.
Program stop confirmation dialog box
OK Clicking this button, analyzer goes into shut down operation.

Log off Clicking this button, following Log in screen opens.
Cancel Clicking this button, screen backs to original screen.
Click Log off button in, Log-in screen is shown.
Log-in screen
Input [User name] and [password] and click Login button.
Log in Clicking this button, start the system program at the specified level.
Cancel Clicking this button, exit the system program.
Default user name and password are followings.
Priority level User Name Password
Operator level User1
Manager level Manager
Service engineer level Service
Simple operation level Easy
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V5.7
4.13 Timer setting and date change confirmation screen
4.13.1 Timer setting
※Timer is located at inside of front in the door.

※System power switch will do the ON and OFF automatically.
※Set time for both ON time and OFF time.
※-①[Out] should be set Auto.
-②PC power and system power switch, please 24 hours ON.
However, at least once a week, please restart the computer power.
＜Example of timer screen＞
1. Timer time setting

Example: Set on [Monday, 4 pm].
① Push MODE button over 1 second. Mode change to [time setting].
② Clock mark（）flickers.
③ Push ｄ button several times till mark hits MO.
④ Push h button and m/PWD button till PM４：００ .
⑤ PushWRITE button. （：）mark starts flicker and clock starts from 0 second.
⑥ Push MODE button 3 times.
2. Timer action setting

Example 1: From Monday to Friday, ON at AM 8:30 and OFF at PM 6:00
① Push MODE button under [time setting]. Timer mode is [action time setting
mode].
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② １ is shown at right bottom of the screen and Ｐ flickers.

③ Input ON time by Pushing h button and m/PWD button till AM 8:30.
④ Push WRITE button.
⑤ Input OFF time by Pushing h button and m/PWD button till PM 6:00.
⑥ Push WRITE button.
⑦ Push Mode button.
⑧ Mode change to [Day of the week setting] mode.
Note: Timer does action on the day of the week, which [ ] mark under the
day of the week sign.
⑨ Repeat pushing ｄ button till mark comes to SU.
⑩ Push WRITE to delete [ ] mark under SU.
Note1: [ ] mark changes alternatively by pushing WRITE button.
Note2: In the same way, delete [ ] mark under SA.
⑪ Push MODE button.
⑫ Screen change to current time display.
Example 2: From Monday to Friday, ON at AM 8:30 and OFF at PM 6:00 and on Saturday,
ON at AM 8:30 and OFF at PM 1:30.
mode].
② １ is shown at right bottom of the screen and Ｐ flickers.
③ Push SELECT button. Ｓ appears right top of the screen.
④ Input ON time by Pushing h button and m/PWD button till AM 8:30.
⑤ Push WRITE button.
⑥ Input OFF time by Pushing h button and m/PWD button till PM 1:30.
⑦ Push WRITE button.
⑧ Ｓ disappears.
⑨ Input ON time by Pushing h button and ｍ/PWD button till AM 8:30.
⑩ Push WRITEbutton.
⑪ Input OFF time by Pushing h button and ｍ/PWD button till PM 6:00.
⑫ Push WRITEbutton.
⑬ Push Mode button.
⑭ Mode change to [Day of the week setting] mode.
Note: Timer does action (power ON) on the day of the week, which [ ] mark
under the day of the week sign. [ ] mark flickers for the SELECT.
⑮ Repeat pushing ｄ button till mark comes to SA.
⑯ Push WRITE to flicker [ ] mark under SA.
Note1: [ ] mark changes circularly ON - OFF - flicker -, by pushing WRITE
button.
Note2: In the same way, OFF [ ] mark under SU.
⑰ Push MODE button.
⑱Screen change to current time display.
Example 3: For the temporary holiday

(Assumption: Timer is set as example 1, but analyzer stop operation on coming
Friday because of holiday.)
① Push HOLYDAY button over 2 second, in current time display mode.
4-151
V5.7
② HdRY flickers right bottom of screen showing [holiday setting mode].

③ Push ｄ button several times till mark hits FR.
④ Delete [ ] mark by pushing WRITE button.
⑤ Push HOLYDAY button.
⑥ Screen back to current time display, but no [ ] mark under FR.
Note1: Holiday setting is possible within 7 days, including applicable holiday.
Note2: When this holiday is over, [ ] mark comes back automatically.
3. Delete timer action setting

mode].
② Push CLR button over 3 seconds.
③ CLr mark appears on the screen and start deletion.
④ When all settings are cleared, −−：−− mark appears on the screen.
⑤ Pushing MODE button twice, screen back to current time display.
4．Restart from the timer OFF

System switch off is done automatically under the timer set AUTO.
If you continue or restart the test from the timer OFF is done by following procedure.
① Change the timer from Auto to ON.
② Wait until "TENP" "OK".
③ Start the test.
④ Turn OFF the system switch after test stop.
⑤ Change the timer from ON to AUTO.
⑥ Turn ON the system switch.
To change priority level, user name and password input are necessary.
4.13.2 Date change confirmation screen
When the date is changed during the system program is on, the following
date change confirmation screen is shown.
※ The screen is shown after end of run when the analyzer is running.
Date change confirmation screen
・ Click OK, the date is changed to new date.

※ Reset the “Order” and related conditions.
・ Click Cancel, the date is not changed.
※ The system program OFF and ON should be done if the date sets to
new.
4-152
Chapter 5 Maintenance
5.1 Maintenance preparation ..............................................................................................5-3

5.1.1 Required tools, goods and parts ..............................................................................5-3
5.1.2 Maintenance Item list.............................................................................................5-4
5.2 Maintenance procedure .................................................................................................5-5
5.2.1 Sample probe ..........................................................................................................5-5
1. Sample Probe Cleaning ..............................................................................................5-5
2. Sample Probe Exchange ............................................................................................5-6
5.2.2 Reagent probe .........................................................................................................5-8
1. Reagent Probe Cleaning ............................................................................................5-8
2. Reagent Probe Exchange ...........................................................................................5-9
5.2.3 Stirrer ................................................................................................................... 5-12
1. Stirrer cleaning ........................................................................................................ 5-12
5.2.4 Reaction cuvette.................................................................................................... 5-13
1. Cuvette exchange ..................................................................................................... 5-13
5.2.5 Separate collection reservoir................................................................................. 5-15
1. Float switch check .................................................................................................... 5-15
5.2.6 Light source .......................................................................................................... 5-16
1. Lamp Exchange........................................................................................................ 5-16
2. Gain Adjustment ...................................................................................................... 5-19
3. Cell check ................................................................................................................. 5-20
4. Reset of the lamp use time after the lamp exchange ................................................ 5-21
5.2.7 Reagent pump (Inside washing) ........................................................................... 5-22
1. Daily inspection........................................................................................................ 5-22
2. U-packing replacement ............................................................................................ 5-23
5.2.8 Probe outside washing pump (PWP) .................................................................. 5-25
1. Daily inspection........................................................................................................ 5-25
2. U-packing replacement ............................................................................................ 5-26
5.2.9 Air removal from the clot sensor ...................................................................... 5-28
1. Preparation .............................................................................................................. 5-28
2. Procedure ................................................................................................................. 5-28
5.2.10 Air trap liquid level check and detergent aspiration method................................ 5-30
1. Air trap liquid level check ........................................................................................ 5-30
2. Air trap detergent aspiration method ...................................................................... 5-30
5.2.11 ISE module........................................................................................................... 5-32
1. Operation on ISE maintenance screen ..................................................................... 5-32
2. Exchange of Calibrator 1 (CAL-1) ............................................................................ 5-34
3. Exchange of Calibrator 2 (CAL-2) ............................................................................ 5-35
4. Exchange of Electrode .............................................................................................. 5-36
5. Exchange of Pump Tube ........................................................................................... 5-37
6. Exchange of PV tube ............................................................................................... 5-38
7. Cleaning of ISE sample line (ISE Wash) .................................................................. 5-39
8. Cleaning of Reagent pot .......................................................................................... 5-41
5-1
V5.7
9. Removal of bubbles at Ref electrode setting ............................................................ 5-42

10. Storage of electrodes............................................................................................. 5-43
5.2.12 Washing of Probe, Cuvette, Stirrer....................................................................... 5-44
1. Special wash ............................................................................................................ 5-44
2. All washing .............................................................................................................. 5-44
5.2.13 Washing solution (Alkaline and Acidic) ................................................................ 5-45
5.2.14 Waste water handling (Reaction waste liquid reservoir) .................................. 5-46
5.2.15 Fuse replacement ............................................................................................... 5-47
1. Fuse maker and type number .................................................................................. 5-47
2. Replacement procedure............................................................................................ 5-47
5.3 Saving of Back-up data ............................................................................................... 5-48
1. How to save back-up data ........................................................................................ 5-48
2. Place where Backup data is saved ........................................................................... 5-49
5.4 Printer (option) ............................................................................................................ 5-50
5-2
5.1 Maintenance preparation
5.1.1 Required tools, goods and parts
1. Necessary tools (Accessories)

① (Plus) Driver
② Tweezers
③ Hexagonal wrench (2.5mm)
④ Nylon wire
2. Necessary goods (Customer preparation)

① Paper wiper or gauze
② Ethyl alcohol
③ Glove, Safety glasses and Mask for preventing infection
3. Necessary parts (Parts No. on the right)

① Sample probe : 50-02-0087
② Reagent probe : 50-03-0106
③ CUVETTE (90pcs/SET) : 50-09-0262
④ Lamp Assy : SP2057
⑤ 14 U Packing with O-ring : SP2070
⑥ Calibrator 1 (420mL) : 20-27-0477F
⑦ Calibrator 2 (140mL) : 30-27-0905F
⑧ ISE Cleaner (25ml) 1% : 50-27-0781F
⑨ ISE Cleaner (25ml) 5% : 50-27-0782F
⑩ Dummy electrode : 50-27-0818
⑪ Na electrode : 20-27-0474F
⑫ K electrode : 20-27-0475F
⑬ Cl electrode : 20-27-0476F
⑭ Ref electrode : 20-27-0473F
⑮ Roller Pump Tube B（ 3 Pieces） : 50-27-0783
⑯ Pinch valve tube : 50-27-0786
⑰ Alkaline Washing Solution 2.5D : 50-24-0747
⑱ Acid Washing Solution 5D : 50-24-0748
Caution
When do maintenance operation, wear protective globes, mask and glasses
to avoid infection. (For infection prevention)
5-3
V5.7
5.1.2 Maintenance Item list
Item Necessary parts Num. Tools, goods

5.2.1 Sample probe Glove
1. Probe cleaning Paper wiper
2. Probe exchange Sample probe 1 (+) Driver
5.2.2 Reagent probe Glove
1. Probe cleaning Paper wiper
2. Probe exchange Reagent probe 1 (+) Driver
5.2.3 Stirrer Glove
1. Stirrer Cleaning Paper wiper
5.2.4 Reaction cuvette Max. Glove
1. Cuvette exchange Reaction cuvette 90 Hex. Wrench (2.5)
5.2.5 Separate collection
Glove ,Paper wiper
reservoir
5.2.6 Light source
Glove
1. Lamp exchange
(+) Driver
2. Auto gain Light source lamp 1
Paper wiper
3.Cell check
Alcohol
4. Reset of the lamp use time
5.2.7 Reagent pump Glove, Tweezers
1. Daily check
φ 14 U-packing 1 (+)Driver
2. U-packing exchange
5.2.8 PWP Glove, Tweezers
1. Daily check 1
φ 14 U-packing (+)Driver
2. U-packing exchange
5.2.9 ISE module Glove

1
2,3. Calibrator 1, 2 exchange Calibrator 1, 2
1
4. Electrode exchange Electrode(Na,K,CL,
1
5. Exchange of Pump Tube Ref)
1
6. Exchange of PV Tube Roller Pump Tube
7. ISE Wash Pinch valve tube ISE washing solution
8. Cleaning of Reagent pot Cotton swab
5.2.10
Glove
Washing of Probe, Cuvette, Stirrer 1
ALK or ACID Washing
1.Special wash
Solution
5.2.11
1
Exchange of washing solutions Glove
ALK or ACID Washing
1
Solution
5-4
5.2 Maintenance procedure
Caution
When do maintenance operation, wear protective globes, mask and glasses
to avoid infection. (For infection prevention)
5.2.1 Sample probe
1. Sample Probe Cleaning

Clean ISE sample probe if the analyzer has ISE unit.
Sample probe ISE Sample probe
① Turn off PC and analyzer power switch before starting the maintenance operation.
② Remove the sampler cover.
③ Pull up STM arm by hand and move and rotate to above the sampler.
※Move it to sample aspirating position or detergent bottle position etc. where to be easily
cleaned.
④ Wipe out the dirt at the outside of probe tip with paper wiper or other material soaked in
pure water.
Note: Please ensure not to bend the probe.

Please wipe the outside the probe from top down.
⑤ Return STM arm to washing position by hand.

⑥ Reset sampler cover at the proper position.
5-5
V5.7
2. Sample Probe Exchange

Carefully exchange ISE sample probe because the method is different
from other probes.
Turn off PC and the analyzer in advance.

① Rotate the STM arm up to the sampler.
② Remove the sampler cover.
③ By removing the cover, the probe fixing screw will be appeared.
* Remove the cover carefully not to drop the fixing screw.
Prove fixing screw

Cover fixing screw Cover fixing screw
Driver
Remove cover
④ Loose the probe fixing screw.
Probe fixing screw
Loosen fixing screw Remove probe
⑤ Take the probe up and remove it from the arm.

⑥ Remove the teflon tube rotating the sample probe.
※Insert the teflon tube into the probe carefully not to injure the inside.
5-6
⑦ Insert the probe into the arm and fix it by probe fixing screw.
⑧ Attach the cover.

⑨ Startup PC and the analyzer, then initialize the analyzer.
⑩ The tip of the probe should be center of the vacuum hole.
* If the probe isn’t in the center, press the probe by your hand and adjust the
position.
Washing trough
Vacuum hole
5-7
V5.7
5.2.2 Reagent probe
1. Reagent Probe Cleaning
① Turn off PC and the analyzer system power switch before starting the
maintenance operation.
② Remove reagent tray cover.
③ Remove a reagent bottle of position.
④ Move up RTM arm by hand and to the reagent bottle position.
⑤ Wipe out the dirt at the outside of probe tip by paper wiper or other material
soaked in pure water.
Note: Please ensure not to bend the probe.

Please wipe the outside the probe from top down.
R1
R2
⑥ Cleaning the R1 probe. Also cleaning the same as R2 probe.

⑦ The probe arm using your hands to return to the position of the trough.
⑧ Setting the reagent tray cover.
5-8
2. Reagent Probe Exchange

Turn off PC and the analyzer in advance.
① Move the reagent probe to bottle position.

② Loose the cover fixing screw and remove the cover.
③ Internal probe appears.
Cover fixing screw
Reagent probe
Driver
After removing the cover
Remove of the cover
④ Remove the JIS connector on LLS board.
Connector
Remove of the connector
⑤ Loose the probe fixing screw

⑥ Take the arm up a little.
⑦ Take the probe up and remove from the arm.
Probe fixing screw
Reagent probe
Probe fixing screw
Remove of the probe
5-9
V5.7
⑧ Remove the tube joint and pull up the probe.
Probe
Teflon tube and Joint part.
⑨ Connect the connector by using tweezers and fix the probe fixing screw.
⑩ Joint part And replace the new probe and fix the probe fixing screw.
Tweezers
Connector
Attachment of the connector

⑪ Fix the arm by your hand and attach the connector.
* Tweezers are convenient.
⑫ Tighten the probe fixing screw.
Attachment of the cover
5-10
⑬ Take the arm up a little.

⑭ Attach the cover and tighten the cover fixing screw.
⑮ Startup PC and the analyzer, then initialize the analyzer.
⑯ The tip of the probe should be center of the vacuum hole.
* If the probe isn’t in the center, press the probe by your hand and adjust
the position.
⑰ After adjustment, initialize again.
* The same procedure for R1 and R2.
Washing trough
Vacuum hole
Probe position check
5-11
V5.7
5.2.3 Stirrer
1. Stirrer cleaning
① Turn off PC and analyzer system power switch before starring the
② Turn the arm to the cuvette position by hand.
Reagent 1 mixing unit Reagent 2 mixing unit
③ Wipe out the dirt at the outside of stirrer by paper wiper or other material
soaked in pure water.
④ Clean up both reagent 1 and reagent 2 stirrer.
⑤ Return the units by hand.
5-12
5.2.4 Reaction cuvette
Note ; The surface of the cell will be tend to scar easily. Please be careful.
1. Cuvette exchange
① Turn off the PC and the analyzer in advance.
② Remove the cell cover.
Stopper
Remove the cell cover. Take off the stopper
③ Bring the stopper up for the cell. (15 cells = 1 block)

Each block has two stoppers.
④ Bring the cell up slowly. If it is hard to remove it, move it back and
forth and around.
⑤ Rotate the RCT by you hand and remove all cells.
Bring the cell up.
⑥ Bring the stopper for new one up.

⑦ Insert the cell to the RCT and press the stopper.
Cell 5-13
V5.7
Note ; Do not touch the optical path face of a cell by fingers.

Insert the cell carefully and slowly not to injure the cell.
⑧ After set of all cells, rotate the cell slowly and check if the cell set
correctly or not.
⑨ Turn of the PC and the analyzer and do initialization.
⑩ Set the cell cover.
*Match the concavity and convexity of the cell cover and the RCT.
5-14
5.2.5 Separate collection reservoir
1. Float switch check
Turn off the PC and the analyzer in advance.

Do not touch the float switch by your hand directly. ※ Please use gloves.
Float switch
Separate collection reservoir
① Loosing Cap of the reservoir and pull up the float switch unit.
② Wipe out water around the filter and other part by Paper wiper for better
working condition.
③ Confirm if the float switch moves up and down smoothly.
④ If you find dart around the float switch, wash out dart by tap water with
brush.
⑤ Return the float switch unit into the drainage reservoir.
⑥ Tighten the cap.
5-15
V5.7
5.2.6 Light source
1. Lamp Exchange
After the lamp replacement, please Auto-gain adjustment.
Caution
Be sure to wait for ten minutes to cool the lamp and lamp house for
maintenance after turning off the system.
The temperature of the lamp rises during operation, and it might cause
burn on your fingers.
Lamp house
Lamp house outskirts
① Turn off the PC and the system power switch and wait for ten minutes to
cool the lamp and lamp house before starting the maintenance operation.
② Open the top cover.
③ Pull up STM arm and turn it to STF side a little.
Fixing screw knobs Pin
Lamp lead terminal

fixing screws (2)
Knob Terminal block
Terminal fixing screw
5-16
④ Remove terminal block cover.

Loosen the lamp lead terminal fixing screws (2) at terminal block by
(+)driver and remove the lamp leads.
Do not over loosen terminal fixing screws.
⑤ Loosen the fixing screw knobs (2 knobs) of lamp holding plate.
Do not over loosen the screws, as the fixing screws designed to be not
removed. While loosening the screw, you will suddenly feel lightly to
turn. This is an indication.
⑥ Holding the knob by fingers, pull up the lamp holding plate.
Note ; Do not touch the glass surface of the lamp.

If you find any dirt on the glass surface, clean it with paper wiper
wetted with ethyl alcohol.
Lamp holding plate
Lamp house
Lamp holding plate
⑦ Remove the lamp fixing screws (2) at lamp holding plate by (+) driver
and remove the lamp.
Slit
Pin
Set the lamp holding plate
⑧ Set a new lamp.

*Set a new lamp, fitting the slit of the lamp flange to the pin on the
lamp holding plate.
⑨ Set the lamp holding plate. Adjust the lamp holding plate position, so
that the holes on the plate fit the pins of the lamp house and fix the plate
by turning two fixing screw knobs.
5-17
V5.7
⑩ Set the lamp leads to the block and fix them by (+) driver.
⑪ Set the terminal cover of the terminal block.
Terminal block
Lamp leads
Terminal fixing screw
Terminal block
Note ： The lamp leads are made a little longer than necessary length.
Push these leads into a slit below, so that these leads are not
damaged.
5-18
2. Gain Adjustment
When finishing the lamp exchange, turn on the system to adjust the gain
(adjustment of the intensity of light).
*Measure the water blank after 15 min from the lamp ON.
Click Ready button, to start the initial operation.

① Clicking Maintenance button, the Maintenance menu screen is shown.
Maintenance Menu Screen
② Clicking Auto-gain in the maintenance menu screen, the Auto-gain screen is

shown.
Auto-gain screen
③ Clicking Start button, the gain for all the wavelengths is automatically
executed.
※If you do not in the ready state, you cannot click the Start button.
④ After auto gain is completed, clicking Save button.
⑤ Clicking Close button, return to the Maintenance Menu Screen.
※ Range of standard water blank: 28,000 – 54,000
5-19
V5.7
3. Cell check
When Auto-gain is finished, perform cell check measurement.
Click Ready button to start the initial operation.

② Clicking Cell Check in the maintenance menu screen, the Cell check screen
is shown.
Cell check screen
③ Clicking Start button, the cell check for all the wavelengths is
automatically executed.
※If you do not in the ready state, you cannot click the Start button.
※Click the Stop button, aborts the measurement operation.
④ After cell check is completed, clicking Save button.

⑤ Clicking Close button, return to the Maintenance Menu Screen.
5-20
4. Reset of the lamp use time after the lamp exchange

When the cell check is finished, perform reset of the lamp time.

② Clicking LAMP button, the following dialog box appears.
③ Clicking CHANGE button.
Lamp screen
④ Clicking OK button. The display changes into “100%”.
Lamp exchange screen
Note: “100%” is 1200 hours, but it is not the indication of its life.
Please get a rough idea to use.
⑤ Clicking Exit button, return to the Maintenance Menu Screen.
5-21
V5.7
5.2.7 Reagent pump (Inside washing)
1. Daily inspection
① This inspection is done in operation.

② Remove the front panel.
Loose lower screw. Hold the lower end of the panel by both hands and pull
it a little to unlock. Then remove.
③ Reagent probe washing pump are fixed on a plate.
Tube joint
Pump head
Seal screw
Tube joint
Reagent 1 Reagent 2
Pump unit front
Reagent washing
pump unit
④ Check if an aspiration and dispensation movement is running smoothly.

・Aspiration----to the lower
・Dispensation---to the upper
⑤ Check if there is not a leakage at the plunger seal nor at the tube joints.
・If the plunger seal leaks, tighten the
seal screw a little by fingers.
・If the tube joint leaks, tighten the joint screw by fingers.
Note If the above operation fails to stop plunger seal leakage, U-packing
has to be replaced.
5-22
2. U-packing replacement
Pump unit removing

Pump head fixing screws
③ Remove the tube joints of both side.
④ Loosen the pump fixing screws, using a Phillip type screwdriver and
remove pump unit.
At the same time, disconnect all connectors, connecting pump unit and
analyzer.
⑤ Loosen head fixing screws(2 screws) and remove a pump head from
the body. When removing the pump head, pull straight up.
Pump head removing
⑥ Remove plunger seal screw from the pump head.

⑦ Remove a spacer.
⑧ Remove U-packing using tweezers.
Seal gasket Holder Seal screw
U-packing
Spacer
The constitution of
pump head seal
5-23
V5.7
⑨ Insert a new U-packing, taking care not to scratch.
Pump head assemble
⑩ Insert a spacer, and set and turn plunger seal screw slightly.
⑪ Assemble pump head to the body.
・If pump head is hard to insert, rotate the head right or left a little while
insertion.
⑫ Tighten seal screw by fingers.
⑬ Set the reagent pump unit to the analyzer.
⑭ Power on PC and analyzer, then initialize.
5-24
5.2.8 Probe outside washing pump (PWP)
1. Daily inspection
PWP1 PWP2 PWP 3 PWP 4 PWP 5
Probe outside washing pump unit
① This inspection is done in operation.

・Loose lower screw. Hold the lower end of the panel by both hands and pull it
a little to unlock. Then remove.
③ Reagent probe washing pump are fixed on a plate.
④ Check if an aspiration and dispensation movement is running smoothly.
Aspiration----to the lower
Dispensation---to the upper
⑤ Check if there is not a leakage at the plunger seal nor at the tube joints.
Note; If the above operation fails to stop plunger seal leakage, U-packing has to be
replaced.
Pump head
Seal screw
Probe washing pump unit
5-25
V5.7
2. U-packing replacement
Pump head piping section Pump head fixing screws
③ Remove the tube joints of both side.
④ Loosen the pump fixing screws, using a Phillip type screwdriver and remove
pump unit.
・At the same time, disconnect all connectors, connecting pump unit and
analyzer.
⑤ Loosen head fixing screws(2 screws) and remove a pump head from the body.
When removing the pump head, pull straight up.
Pump head removing
⑥ Remove plunger seal screw from the pump head.

⑦ Remove a spacer.
⑧ Remove U-packing using tweezers.
Seal gasket Holder Seal screw
U-packing Spacer
The constitution of pump head seal
5-26
⑨ Insert a new U-packing, taking care not to scratch.
Pump head assembling
⑩ Insert a spacer, and set and turn plunger seal screw slightly.
⑪ Assemble pump head to the body.
・If pump head is hard to insert, rotate the head right or left a little while
insertion.
⑫ Tighten seal screw by fingers.
⑬ Set the reagent pump unit to the analyzer.
⑭ Power on PC and analyzer, then initialize.
5-27
V5.7
5.2.9 Air removal from the clot sensor
Air removal procedure from the clot sensor is as follows.
1. Preparation
① Air removal tool for clot sensor [parts code :50-26-0744]
This tool consists of socket, packing, joint and Poaron tube (1 , 35 cm)
Poaron Tube joint packing socket
② Syringe(5mL), tip of syringe ( this tip is initially attached to accessory tube

for air trap)
Note : Do not use syringe other than 5 mL size. If the size is larger
than 5 mL clot sensor can be damaged.
Tip of air trap accessory tube
※ Take off tip from air trap accessory

tube and attach to syringe
Air trap accessory tube
Insert the tip into the Poaron

tube end of the air removal
Air trap accessory tube tip syringe (5mL)
Connect ① Air removal tool for clot sensor and ② syringe and tip to
complete the air removal jig
2. Procedure
① Main power supply turns ON, and start software program.
② Turns ON the system power supply.
③ Run [READY] to initialize the analyzer.
④ Remove STM arm cover, and remove Teflon tube from the sample probe.
5-28
Teflon tube
⑤ Connect Teflon tube and air removal jig
Teflon tube
Connect air removing

jig and Teflon tube
Syringe is at the end of this Poaron tube
⑥ Open Manual operation screen. [Maintenance] [M. Function] select

unit [11.SP ]
⑦ Select [SP1 PULL (530µL)] and click [RUN].
⑧ Select [SV1 ON] and click [RUN].
⑨ Select [SP1 PUSH (530µL)] and click [RUN].
⑩ Select [SV1 OFF] and click [RUN].
⑪ Pull syringe to 5 mL, and release. Repeat this 5 times. Syringe will
automatically move back to the initial position when released.
⑫ Pull the syringe and keep it at 5mL line then remove the syringe from the
Poaron tube. Discard water inside the syringe.
⑬ Reattach syringe to Poaron tube again.
⑭ Repeat step ⑦∼⑬ 6 times.
⑮ Visually confirm no air bubble to be found in the clot sensor flow path.
⑯ Disconnect the air removal jig from Teflon tube and set the sample probe
back in place
⑰ Run [ READY ]
Note : Even if repeating above procedures does not remove air from
clot sensor, or continues to entrap air, air may be entering from
the membrane or the joint area.
In such case, replacement of the clot sensor is recommended.
5-29
V5.7
5.2.10 Air trap liquid level check and detergent aspiration method
1. Air trap liquid level check

① Confirm the detergent in the air trap is enough level.
Note：The detergent surface should be upper the SUS pipe.
② If the detergent is below the SUS pipe, refill the detergent by
referring to the next "2. Air Trap detergent aspiration method".
Acid Alkaline
Front view SUS pipe
Air trap
2. Air trap detergent aspiration method

① Fill the air trap with washing solution.
Acid Alkaline
Front view SUS pipe
Air trap
Right side ; SUS pipe is attached

Connect to the detergent line.
Left side ; No SUS pipe
Connect to the WSP line.
Caution ：Do not change the position.

The air will comes into the WSP.
5-30
② Remove the tube with stop pin.
Tube with stop pin
③ Insert the syringe tip to fitting

④ Pull the syringe slowly, and fill the detergent to the air trap.
Caution; The detergent surface should be upper the SUS pipe.
SUS pipe
Aspirate the detergent
⑤ Remove the syringe, and replace the tube with stop pin.
5-31
V5.7
5.2.11 ISE module
For using ISE, you need to care about the following maintenance regularly.
1. Exchange of calibrator 1 and calibrator 2
2. Exchange of electrode
3. Exchange of Pump tube
4. Exchange of PV tube
1. Operation on ISE maintenance screen

① Click Maintenance button.
② The following Maintenance menu screen is shown.

Clicking ISE button in Maintenance menu screen.
Maintenance menu screen
③ The following ISE screen is shown. Click Maintenance button on the

screen.
ISE screen
5-32
④ The following ISE Maintenance screen is shown.
ISE Maintenance
For ISE maintenance, you need to ISE maintenance screen.

ISE Wash Request of going into ISE unit washing.
Maint.Mode Request of going into maintenance mode at the electrode
exchange
Maint.Cancel Request of cancel of maintenance mode.
Purge The unit discharges calibration liquid from ISE unit, and
delivers Cal-1.
Calibration Request of calibration measurement of serum sample.
Calb.Result Request of calibration result of serum sample.
The latest measured results are shown.
U-Calib Request of calibration measurement of urine sample
U-Cal result Request of calibration results of urine sample
The latest measured results are shown.
ROM Version Request of ROM version number.
Flow sensor Request of flow sensor value. The newest flow sensor AD
value is outputted at bottom part.
Liquid info. Request of liquid level sensor
Initialize Request of ISE unit initializing.
Multiple measure Request of ISE multiple measurement
Maintenance command ISE Maintenance command screen is shown.
(Sending Cal.1, Sending Cal.2, Drain in electrode, Drain
in pot)
Position Set ISE probe setting.
※Please do not change the setting.
Close Click Close button to close the screen.
5-33
V5.7
2. Exchange of Calibrator 1 (CAL-1)
① Open the ISE maintenance screen before starting maintenance.

Click Maintenance button. Maintenance menu screen is shown.
Click ISE button, and then Maintenance button. ISE maintenance screen
is shown.
② Holding the used Cal-1 pack upside up, remove the cap, and then take off the
cap from hook to dispose.
Connecting Cap
③ Hooking the new Cal-1 pack, screw the cap into the pack, holding it upside
up.
④ Click PURG in ISE Maintenance screen.
⑤ Repeat ordering Purge till no bubble comes out from the tube and no error
occurs.
⑥ Then click Cancel button in ISE Maintenance Screen
⑦ Click Reagent in ISE maintenance screen.
Check Change This boxes on Reagent1 and then click Update Set button.
Residual amount of Cal-1 is updated.
5-34
3. Exchange of Calibrator 2 (CAL-2)
① Open the ISE maintenance screen before starting maintenance.

Click Maintenance button. Maintenance menu screen is shown.
Click ISE button, and then Maintenance button. ISE maintenance screen
is shown.
② Holding the used Cal-2 pack upside up, remove the cap, and then take off the
cap from hook to dispose.
Connecting Cap
Hook
Cal-2 pack
Cal-1 pack
③ Hooking the new Cal 2 pack, screw the cap into the pack, holding it upside
up.
④ Click Calibration in ISE Maintenance screen.
⑤ Repeat ordering Calibration till no error occurs. Click Clib.result and check
the Calibration result. Then click Cancel button in ISE Maintenance screen.
⑥ Click Reagent in ISE maintenance screen. Check Change This boxes on
Reagent2 and then click Update Set button. Residual amount of Cal-2 is
updated.
5-35
V5.7
4. Exchange of Electrode
Holding plate
① Open ISE Maintenance screen. ( Maintenance ISE Maintenance).

Click Mainte mode button and the liquid in ISE unit drains away.
② Open ISE door, and push down the holding plate.
③ While holding the plate down, pull out electrodes.
Connecting plate
④ Remove all the old electrodes (Na, K, Cl, Reference) from the connecting
plate.
⑤ Put all the new electrodes (Na, K, Cl, Reference) on a connecting plate.
Keep the holding plate down, and insert the new electrode to the backs.
⑥ Click Mainte Cancel and calibrator 1 is filled in ISE unit.
⑦ Executing Mainte Cancel , confirm there is no leakage from the electrodes.
If leakage is found, repeat from 1 to 5.
⑧ Close the electrode cover, and close ISE door.

⑨ Click Close button.
⑩ Check Change This boxes of Na, K, Cl on Electrode screen.
⑪ Then click Update Set button. Residual test number is updated.
5-36
5. Exchange of Pump Tube

※Please exchange once every three months.
① Remove CAL-1 pack and CAL-2 pack from the hook to prevent leaking from
the tube.
② Open ISE Maintenance screen ( Maintenance ISE Maintenance). Click
Mainte mode button and the liquid in ISE unit drains away to take off the
liquid in the tube.
Lever presser
③ Turn the lever presser to outside to loosen the tubes. Perform the 4 lever.
④ Remove the tube joint from hook and remove the old pump tube.
⑤ Exchange the new pump tube.
⑥ The new tube place the center of roller and hook the joints. Then put back the
lever presser.
⑦ Hang Cal-1 pack and Cal-2 pack on the Click Mainte Cancel button and
calibrator 1 is filled in ISE unit.
⑧ Click Close button.
⑨ Check Change These boxes of Pump Tube on Electrode screen.
⑩ Then click Update Set button. Residual test number is updated.
5-37
V5.7
6. Exchange of PV tube
※Please exchange once a year.
① Remove CAL-1 pack and CAL-2 pack from the hook to prevent leaking from
the tube.
② Open ISE Maintenance screen ( Maintenance ISE Maintenance). Click
Mainte mode button and the liquid in ISE unit drains away to take off the
liquid in the tube.
PV valve, PV tube
③ Pushing head of PV valve, remove PV tube in the groove of the pinch valve.
④ Exchange the new PV tube.
⑤ Set the new PV tube, inserting in the groove.
Pull
Push
PV tube
⑥ Replace the Cal-1 pack and Cal-2 pack on the instrument.

⑦ Click Maint cancel to closing the Maint mode.
⑧ Click Close button.
⑨ Check Change This boxes of PV Tube on Electrode screen.
⑩ Then click Update Set button. Residual test number is updated.
5-38
7. Cleaning of ISE sample line (ISE Wash)

※Please ISE wash every day.
Electrodes are washed with dedicated detergent (ISE Cleaner).
Note: After electrode cleaning, calibration is necessary before starting ISE test.
ISE CLEANER (1%):

Use for the ISE washing at the end of the day in daily maintenance.
Use genuine brand ISE CLEANER. If you use another detergent, the electrode
membranes should be damaged.
ISE CLEANER (5%): Option

Use for the special wash when the daily maintenance is not effective.
Perform the special washing if the slopes become low or the results are not stable.
Note : ISE CLEANER (5%) causes damage to the electrodes.

Please change the electrodes to dummy before using the ISE CLEANER (5%).
Normally, use it around once every week. If the detergent is used more
frequently than once a week, the probe and the flows are probably damaged.
Any troubles which is caused in the use of ISE CLEANER without dummy
electrode cannot be covered under warranty.
It is an exclusive detergent. Do not use to the other washing.
① Preparation of cleaning solution.
Set the sample cup to

ISE Wash position.
Pour 400uL cleaning solution. ISE Wash position (Wash C, E30)
② Click Maintenance button in Monitor screen.

③ Click ISE button in maintenance screen.
5-39
V5.7
Maintenance screen
④ Click Maintenace in ISE screen.
ISE screen
⑤ Click ISE wash in ISE maintenance screen.
ISE Maintenance screen
⑥ Cleaning solution is dispensed in ISE to clean the inside of ISE line Cleaning
can start at Ready state.
5-40
8. Cleaning of Reagent pot ※ Please clean Reagent pot every day.
Reagent pot
ISE cover
① Remove ISE cover on the upper panel.

② Click Maintenance and click ISE button on Maintenance menu.
③ Click Maintenance button.
④ Click Maint Mode button and the liquid in ISE unit drains away.
Cotton swab
Reagent pot
⑤ Wet a cotton swab with deionized water.

⑥ Get off the stain on the inner wall of the pot with the wet cotton swab.
Note: Be careful not to leave cotton thread in the pot. The flow of the liquid
might be stuffed.
⑦ Click Mainte cancel button after cleaning. ISE unit is filled with Calibrator
1.
⑧ Put on the ISE cover after confirming that any error message is not shown.
5-41
V5.7
9. Removal of bubbles at Ref electrode setting
In case there is any bubble in the ion passage of Ref electrode, remove the
bubble as follows.
① Peel off the seal on the air hole of the electrode, and leave it open.
Air hole Micropipette
Passage joint
Ion passage
② Fill the micropipette with Cal-2, and insert the tip of the micropipette from
the end of the passage joint to the ion passage.
③ Make a rush of Cal-2 from the micropipette.
The bubble is removed, and Cal-2 spills over from the end of the passage joint.
④ Pull out the micropipette.
⑤ Make sure that no bubble is in the ion passage of the electrode.
If there is still any bubble, repeat the procedure from 1.
⑥ Wipe off the spilt liquid all over the electrode, if any.
5-42
10. Storage of electrodes
In case of turning off the power of ISE unit more than four days, keep the
electrodes as follows.
The explanation is given for Ref electrode, but keep other electrodes likewise.
① Fill the passage of the electrode with Cal-2, using a micropipette.
Micropipette
Passage joint
② Fix the attached seals to the both ends of the passage not to let the liquid leak
out. Wipe off around the exits before fixing the seals. Also, wipe out the
spilt liquid.
Seal
③ Put the electrodes in each case to keep at the room temperature.
When restarting ISE measurement after the storage of electrodes;

・Make sure that no bubble is in the ion passage of Ref electrode.
・After setting the electrodes to ISE unit, perform “PURG” twice.
・Check the flow of the liquid.
5-43
V5.7
5.2.12 Washing of Probe, Cuvette, Stirrer
Maintenance
● Special Wash: 90 cells are washed in the same procedure as measurement.

※ Please do this action after the final measurement of the
day every day.
● All Washing : Sequent washing(Probe washing, Cuvette washing ,stirrer
washing) is done.
1. Special wash
Wash the analyzer same procedure as normal measurement. (about 26 minutes)
① Set the detergent bottles to the position 1 (Acid 30%) and position 2 (Alkaline
15%) before start the washing.
② Start the washing by clicking of “Maintenance”, “User maintenance” and select
“Special wash 1 (use Acid detergent)” or “Special wash 2 (use Alkaline
detergent)”.
Note; Please do this washing after measurement every day.

The detergent needs to be selected according to the type which is going to be
washed.
Metallic contamination: Use 30% diluted solution of Acid detergent 5D.

Protein contamination: Use 15% diluted solution of Alkaline detergent 2.5D.
2. All washing
Sequent washing is done automatically in this order, “Probe wash” “Cell
wash” “Mixing stirrer” (about 15 minutes.)
① Set “Alkaline detergent” in each detergent position (No. 2) for sample, R1,
and R2 before washing.
② Click Maintenance User Maint All washing and the washing
starts.
③ The reagent probe aspirate 240 uL of the detergent and the sample probe
aspirates 25uL of the detergent.
5-44
5.2.13 Washing solution (Alkaline and Acidic)
For cleaning use alkaline detergent and acid detergent.
Detergent bottle
Alkaline detergent bottle (1000mL) Acid detergent bottle (1000mL)
※When you exchange the bottle, please put on safety globes.

1. Opening the front panel, take the washing solution bottle out.
2. Remove the bottle cap.
3. Exchange new washing solution bottle.
4. Attach the bottle cap.
5-45
V5.7
5.2.14 Waste water handling (Reaction waste liquid reservoir)
Caution Biohazard
The content of waste bottle contains sample, which may cause infectious disease.
When do maintenance operation, wear protective globe to avoid infection and be careful
not to spill the waste liquid.
Reaction waste liquid reservoir (10L)
1. Open the front panel.

2. Remove the connecter attached with the instrument.
3. Remove the cap of reservoir.
4. Please throw away waste liquid.
5. Attach the cap and connecter.
Caution
The content of waste bottle contains sample, which may cause infectious
disease.
When you discard these waste, follow the instruction of qualified operator
and related law.
Some reagent, standard sample and control sample may contain regulated
substance.
When discard, consult to the maker about regulation for these substance.
Strictly follow laws and regulations of your country when discarding waste
water, reagents and samples.
5-46
5.2.15 Fuse replacement
Caution
Before to start operation, please read [safety caution].

Please do not use other than subscribed fuse.
Always switch off circuit breaker on back of unit before starting fuse replacement work.
1. Fuse maker and type number
Type number of fuse and maker
Type number Specification

F400-01B2 (10A, 250V) Time-Lag
Main power part
2. Replacement procedure
Fuse
Main power
① Turn off main breaker of analyzer and PC power switch.

② Turn the black knob, located at power supply section on right side panel, to
the left and take out a fuse box.
③ Remove the fuse.
④ Confirm if fuse is really OFF, using circuit tester.
⑤ If fuse is surely OFF, insert new one into the socket.
⑥ Set transparent cover and recover side panel.
5-47
V5.7
5.3 Saving of Back-up data
Save back-up data in case the program is broken.
Note： Make sure that [SQL Server Management Studio] and [Analyzer software]
are closed before [Database Manager] is used.
1. How to save back-up data

① If [Analyzer software] or [SQL Server Management Studio] is running,
close it.
② Click Start icon at the bottom left of the screen in order to open All
Programs.
③ Click [Database Manager] in the BIOLIS 50i folder.
Click Database Manager.
④ Backup Tool screen is opened.

⑤ Select 1.Backup
⑥ Click Backup
⑦ If “Success!” is displayed, saving Backup Data is completed.
⑧ Click OK
⑨ Go back to the Backup Tool screen.
⑩ Click × resulting in closing the Backup Tool screen.
5-48
2. Place where Backup data is saved

The data is saved in “BiOLiS Database” folder.
The file name is [ B48iDatabaseBackup. (Saved date)].
※PC¥OS(C:)¥BiOLiS Database folder
Note: Save the backup data in a flash memory such as a USB memory.
※It is recommended that you use a USB memory only for backup data which
virus is removed from in terms of security.
Important Recovery of Backup Data
※1 Use the backup data file which is saved in the same PC for recovery.
If a backup data file saved in another PC is used for recovery, it is not
guaranteed that the analyzer properly works.
※2 When the program version at the database backup is different from

the current version, conduct as follows.
・The version at backup > the current version (version down)
Recovery can be conducted, however, it is not guaranteed for
operation. Recover the database, uninstall the BIOLIS 50i software
and install the latest version of the BIOLIS 50i software for version
up of the database.
・The version at backup < the current version

Recover the database, uninstall the BIOLIS 50i software and
install the latest version of the BIOLIS 50i software for version up
of the database.
・The version at backup = the current version

The software properly works. If you conduct the case of above, it is
no problem for operation.
Refer to Service Manual for the recovery method.
5-49
V5.7
5.4 Printer (option)
Paper cover
Paper
(Left side)
Power switch
(Front)
Power lamp
Printer body Control panel
(1). Prints measurement results and item parameters.

Power switch: turns power ON.
Power lamp: putted on when power switch turns ON. Putted out when
papers run out.
FEED switch: sends papers while pushing button.

(This is available in OFFLINE)
ON LINE lamp: put on in ON LINE.
Blinks when data remains in memory in OFF
LINE.
OFF LINE lamp: put on in OFF LINE.
Blinks when papers run out.
※ON LINE lamp and OFF LINE lamp are put on in case of error.
(2). Paper setting method

① Bring paper cover down backward.
② Insert an end of paper into slot. Paper is automatically sent

and comes out from discharge port.
※ Outside of thermo-sensitive paper is set to front.
③ Close paper cover.
5-50
(3). Paper runs out in measurement

When paper runs out in measurement, printing stops.
After exchanging paper, only data remaining in printer memory is
printed out.
(4). Connection between power supply and analyzer

① Connect AC power supply.
② Connect RS232C cable with printer connector on back face of
the analyzer.
③ Turn on power switch in left side.
Power switch
(5). Analyzer settings

When you connect printer, check レ of internal printer in system
screen.
Caution When you check レ , certainly turn on printer power for operation.
If you operate the analyzer while printer power is OFF (error
indicated in start-up), some of malfunctions probably occur.
5-51
Chapter 6 Check Flag ・ Alarm Function
6.1 Check flag ..................................................................................................................... 6-3

6.1.1 Data message flag .................................................................................................... 6-3
6.1.2 Short sample/reagent check flag.............................................................................. 6-4
6.1.3 Out-of-range frag ..................................................................................................... 6-4
6.1.4 Action for a message flag is printed......................................................................... 6-5
6.2 Warning Dialog Box（Error list） ............................................................................... 6-6
1. Warning Dialog Box .................................................................................................. 6-6
2. Warning Dialog Box details ...................................................................................... 6-7
6.3 Error number and message list.................................................................................... 6-8
6.4 Error causes and solutions .......................................................................................... 6-11
6.5 ISE error code list .......................................................................................................6-18
6.6 ISE error causes and solutions ...................................................................................6-20
6.7 ISE other errors...........................................................................................................6-25
6-1
V5.7
6-2
6.1 Check flag・Alarm Function
There are three kinds of check flags, out of range error, data error and liquid
shortage error.
6.1.1 Data message flag
Each message flag has its priority order. If multiple messages would
occur, the message with the highest priority appears.
The following messages are shown in order of priority.
Priority for display; C >T > E >B, G >P > L >AB > t
※ In case of “V”, priority for display;
C >E >B, G >P >L >AB >V >T, t
※ ”Q”only displays in case of no other flag.
C The cell blank value is lower than Cell check Level 1 or higher
than Level 3.
T Reaction tray temperature is out of the set temperature plus-minus 0.1
degree Celsius, while measurement.
E In case of END point assay:---Cell blank subtracted Abs of main
wavelength, is higher than [Endpoint Limit].
B (1) or (2) and (3): (1) The Abs at main wavelength at start test
point is lower than Abs limit [Low] in item parameter screen. (2)
The Abs at end test point is lower than the limit [Low]. (3) The
Abs of any test point of consecutive 3 points from start test point
is lower than the limit [Low].
Or the result density is lower than the result warrant limit
[Low] when HbA1c (Item number 106) is measured.
G (1) or (2) and (3): (1) The Abs at main wavelength at start test
point is higher than Abs limit [High] in item parameter screen.
(2) The Abs at end test point is higher than the limit [High]. (3)
The Abs of any test point of consecutive 3 points from start point
is higher than the limit [High].
Or the result density is higher than the result warrant limit
[High] when HbA1c (Item number 106) is measured.
P Prozone is detected. The prozone check result exceeds the upper or
lower limit.
L In case of RATE assay:---Linearity check result exceeds [LINEARITY
CHECK] value.
AB The Abs average of 3 points, which is centered upon set test points
in item parameter screen, is out of range.
Or the result is higher than the Lysing absorbance check when
HbA1c (Item number 106) is measured.
6-3
V5.7
t Test is done while warming-up.
Note: “ While warming-up” means the time interval, which the

temperature of reaction tray has not yet reached to the set
temperature plus-minus 0.3 degree Celsius after the system
power is turned on.
V Data is too high or low. Rerun with dilution or confirm the reaction
Abs..
Q Measurement results of quality control sample was out of the SD
management range.
※ Flag for calibration

F For Linear 1 calibration, the slope between blank and standard is out of
set range of item parameter from [Factor Max] to [Factor Min].
CV For Linear 1 calibration, the coefficient of variation (CV %) is higher
than item parameter [CV Max].
6.1.2 Short sample/reagent check flag
Short liquid check flags are printed in S column.

S Shortage of sample or detergent
R1 Shortage of 1st reagent, detergent or hemolyzing reagent in case of
HbA1c test
R2 Shortage of 2nd reagent or detergent or detergent
RR Shortage of both 1st and 2nd reagents or detergent
SR Shortage of sample and 1st and (or) 2nd reagent or detergent
C The clot sensor check result exceeds the upper limit.
CR The clot sensor check result exceeds the upper limit and shortage of
1st and (or) 2nd reagent or detergent
6.1.3 Out-of-range frag
This is a flag for out of normal range or panic range.

Low The result is lower than item parameter [Normal range –
Low].
High The result is higher than item parameter [Normal range –
High].
PL The result is lower than [Panic range – Low].
PH The result is higher than [Panic range – High].
6-4
6.1.4 Action for a message flag is printed
C Reaction cell is dirty. Replace reaction cell.

Replace lamp if all cell blank data are 3.125 Abs.
T When room temperature is high, turn OFF main switch and leave
the analyzer around 20 minutes. Restart analyzer and try to run
again under the condition of open top cover. If the same flag
appears again or room temperature is low enough, please let us
know.
E Data is too high. Rerun with dilution.
B Data is too high. Rerun with dilution.
G Data is too high. Rerun with dilution.
P Rerun with dilution.
L Data is too high. Rerun with dilution. Replace a lamp. Light
intensity might be unstable because of end of life.
AB Rerun. Check reaction monitor.
t Same as flag T.
V Data is too high or low. Rerun with dilution or confirm the
reaction Abs..
Q Rerun.
For the short liquid flag, check sample, reagent and hemolyzing volume
in container.
Note: If you get any strange message flags(C~G) as above, please

confirm whether item parameter setting is correct.
Please refer to “Chapter4, 4.6Item Parameter”.
6-5
V5.7
6.2 Warning Dialog Box（Error list）
1. Warning Dialog Box
When an error occurred, the following dialog box appears.

Clicking Error list button in Monitor screen or Clicking Maintenance button and
then Error list button, the following Error list screen is shown.
Error list screen
Errors are displayed in this error list screen.
[Date Time] Occurrence time of error

[Error] Types of error
[Unit No] Identification of unit
[Error No] Identification of error
[Func. No] Identification of function
[Sample No] Identification of sample
[Item Name] Identification of item name
[Detail No] Identification of detail
[Message] Error message
[Comment] Comment
Exit Back to the Maintenance screen
6-6
2. Warning Dialog Box details
Error list is constructed like previous page.

When you see solutions pages, please check the following numbers before seeing
"Error number and message" page.
① ② ③
① [Error]number
② [Unit No]number
③ [Error No]number
After searching the above numbers from "Error number and message" pages,
please see the "Error causes and solutions" pages.
6-7
V5.7
6.3 Error number and message list
Error Unit Error

No. No. Message Ref.No.
Kind No. No.
1 1 1∼39 1 9000000 Limit detection - (Unit name) 1
2 2 1∼39 1 9000040 Alarm - (Unit name) 2
3 3 1∼39 1 9000080 Emergent stop - (Unit name) 3
4 4 1∼39 1 9000120 EA/EB Input error - (Unit name) 4
5 5 1∼39 1∼9 9000160 Movement time-out - (Unit name) 5
6 6 1∼39 1∼9 9000200 Abnormal movement position - (Unit name) 6
7 7 1∼17 1∼9 9000240 Safety error - (Unit name) 7
8 8 1∼39 1∼9 9000280 Other movement error - (Unit name) 8
Communication error - Illegal contents of the
9 11 71 1∼9 9000320 9
command
10 21 72 1 9000321 Detector error 10
11 41 41 1 9000326 Acid tank error - empty 11
12 41 42 1 9000327 Alkaline tank error - empty 12
13 41 44 1 9000429 Water supply tank error - empty 13
14 42 45 1 9000324 Drainage tank error - full 14
15 42 46 1 9000325 Separate Collection Reservoir error - full 15
16 43 6 1 9000329 Short sample error 16
17 43 8 1 9000330 Short reagent1 error 17
18 43 10 1 9000331 Short reagent2 error 18
19 44 3 1 9000332 RCT overflow error 19
20 45 51 1 9000333 Sample probe clot occurs 20
21 45 51 2 9000334 Sample probe clot recovery 21
22 45 51 3 9000335 Serious sample probe clot (service call) 22
23 51 49 1 9000339 RCT - Abnormal temperature 23
24 51 49 2 9000340 WSH - Abnormal temperature 24
25 51 50 1 9000449 WSH - Abnormal water level 25
26 61 71 2 9000342 Not "Ready" 26
27 62 71 5 9000347 Round abnormality - Reagent 1 position 27
28 62 71 6 9000348 Round abnormality - Reagent 2 position 28
29 62 71 8 9000458 Round abnormality - Lysing solution position 29
30 63 71 1 9000350 Item buffer - full 30
31 64 71 1 9000352 Command parameter error 31
81∼
32 81 1∼5 9000353 Database access error（Command name） 32
90
33 83 86 2 9000373 Different type of calibration samples 33
34 83 86 1 9000372 Calibration search error 34
35 83 87 4 9000375 Sample bar-code error 35
36 83 87 3 9000374 Sample bar-code read error 36
37 83 87 6 9000377 No sample ID 37
38 83 87 5 9000376 No sample cup 38
39 83 87 7 9000378 Sample position error 39
Excessive amount of Lamp - Please change the
40 85 82 1 9000457 40
Lamp
41 85 86 1 9000383 Absorbance maximum over 41
42 85 86 2 9000384 Deviation of calibration changes 42
6-8
Error Unit Error

Kind No. No.
43 85 86 3 9000385 Absorbance error 43
44 86 86 8 9000394 Stack error 44
45 86 86 6 9000392 Rearranging error of the calculating formula 45
46 86 86 7 9000393 Calculation formula error 46
47 86 86 4 9000390 Calibration database reading failure 47
48 86 86 5 9000391 Calculation check error 48
49 86 86 3 9000389 Item parameter check error 49
50 86 86 1 9000387 No sample data 50
51 87 81 1 9000396 Reagent error- No item number 51
52 87 87 2 9000397 Reagent error ????? 52
53 87 87 3 9000397 Reagent error ????? 53
54 87 87 1 9000398 Warning short reagent 54
55 87 88 1 9000399 Reagent - out of expire date 55
56 88 82 5 9000403 Device communication error 56
57 88 82 6 9000459 Device communication error - Check sum error 57
Device communication error - Size error in
58 88 82 7 9000460 58
message
59 88 82 2 9000404 Device communication error - Response timeout 59
60 88 82 3 9000401 Device communication error - Same MT received 60
Device communication error - Response MT
61 88 82 4 9000402 61
difference
61’ 88 82 8 9000478 Device communication error - Run cycle difference 61’
62 88 82 1 9000400 Device communication port open error 62
63 90 82 1 9000425 Printer error 63
64 90 82 3 9000469 Reaction cuvettes are stained. 64
65 90 83 2 9000427 Position error 65
66 90 88 3 9000428 Lamp life is approaching 66
67 91 86 1 9000359 ISE Error! 67
68 91 86 2 9000360 ISE Sample speciman not supported 68
69 91 86 3 9000474 ISE default setting error. 69
70 91 88 5 9000361 Exchange time - Na erectrode 70
71 91 88 6 9000362 Exchange time - K erectrode 71
72 91 88 7 9000363 Exchange time - Cl erectrode 72
73 91 88 8 9000364 Exchange time - Ref erectrode 73
74 91 88 9 9000365 Exchange time - ISE pump 74
75 91 88 3 9000371 ISE communication error! 75
76 92 88 5 9000366 Exchange time soon - Na erectrode 76
77 92 88 6 9000367 Exchange time soon - K erectrode 77
78 92 88 7 9000368 Exchange time soon - Cl erectrode 78
79 92 88 8 9000369 Exchange time soon - Ref erectrode 79
80 92 88 9 9000370 Exchange time soon - Calibrator1 80
81 92 88 4 9000463 Exchange time soon - Calibrator2 81
82 93 81 0 9000461 ASTM communication open error 82
83 93 81 2 9000462 ASTM communication breakdown 83
84 93 81 1 9000406 ASTM - Send message unable 84
85 93 81 3 9000408 ASTM - Timeout 85
6-9
V5.7
Error Unit Error

Kind No. No.
86 93 81 4 9000409 ASTM - NAK received 86
87 93 81 5 9000410 ASTM - Over record length 87
88 93 81 6 9000411 ASTM - Measurement request registration error 88
ASTM - Requested sample is during measurement
89 93 81 7 9000412 89
or completed the measurement
90 93 81 8 9000413 ASTM - Position error 90
91 93 81 9 9000414 ASTM - No request specified 91
92 94 81 0 9000415 ASTM - No Patient information 92
93 94 81 1 9000416 ASTM - Item error 93
94 94 81 2 9000417 ASTM - Abnormal message error 94
95 94 81 3 9000418 ASTM - Position check error 95
96 94 81 4 9000419 ASTM - Short field 96
97 94 81 5 9000420 ASTM - Delimiter split error in message 97
98 94 81 6 9000421 ASTM - Existence check error 98
99 94 81 7 9000422 ASTM - Lens check error 99
100 94 81 8 9000423 ASTM - Value check error 100
101 94 87 9 9000424 ASTM - Retry over 101
ISE washing is not able to start. Please do
102 95 99 1 9000452 102
"Ready".
ISE calibration is not able to start. Please do
103 95 99 2 9000453 103
"Ready".
104 95 99 3 9000454 ISE - Nozzle error 104
ISE is not able to move because of maintenance
105 95 99 4 9000455 105
mode.
106 95 99 5 9000456 ISE maintenance operation, no cups! 106
107 97 99 1 9000432 Undefined motor number! 107
108 97 99 2 9000433 Stop positioning zero! 108
109 97 99 3 9000434 Stop positioning index! 109
110 98 99 0 9000464 Communication error - ISE unit! 110
111 98 99 1 9000436 Communication error - Sample barcode! 111
112 98 99 2 9000437 Communication error - Reagent barcode! 112
113 98 99 3 9000438 Communication error - Sample level sensor! 113
114 98 99 4 9000439 Communication error - ISE level sensor! 114
115 98 99 5 9000440 Communication error - Reagent1 level sensor! 115
116 98 99 6 9000441 Communication error - Reagent2 level sensor! 116
117 99 99 1 9000444 System Error. Message too long! 117
118 99 99 2 9000445 System Error. No message here! 118
119 99 99 3 9000446 System Error. Timeout! 119
120 99 99 4 9000447 System Error. 120
6-10
6.4 Error causes and solutions
Ref
No.
Cause Solution
UNIT1 or UNIT2 controller may be broken.
1 When [Mixing1 rotation] or [Mixing2 rotation]
errors occur, UNIT1 or MCPU PCB may be broken.
①Encoder may be broken.
4
②UNIT1 or NIT2 controllers may be broken.
・This message is shown if an unit doesn't return
home position within a certain time.
・While doing measurement, if the software try Please call our service division.
to let the unit do other movement, this message
5 is shown.
Causes are as following.
① Sensor may be broken.
② Motor may be broken.
③ PCBs may be broken.
①Home sensor may be broken.
② There are some differences between actual
value and theoretical value of Rotary encoder
6 (except for vertical motion units and pumps).
＊ In an unit without encoder, when the unit
return to 0 position, if the unit is not in the
sensor position, this message is shown.
① Please do "Ready" mode.
Other unit is in the position disturbing
7 ②If the symptom is not improved,
movement of the unit which the message shows.
please call our service division.
There are some error except Limit abnormality,
① Please do "Ready" mode.
alarm, emergency stop, EA/EB input error. The
8 ②If the symptom is not improved,
causes are as following.
UNIT1 or UNIT2 PCB may be broken.
①Please change the cable
The connection between the machine and PC may be ②If there are some causes around
impossible. the machine and PC, please away from
9
①There are some noises in communication line. it.
②There is a problem in the communication line. ③If the symptom is not improved,
①A motor of RCT may be broken.
②Connection between RCT motor and PCB may have
been disconnected.
10 Please call our service division.
③There is a problem in the communication with
SCPU PCB.
(One of PCBs may have been damaged.)
6-11
V5.7
Ref
No.
Cause Solution
Please change acid detergent
11 There is no acid detergent.
bottle.
Please change alkaline detergent
12 There is no alkaline detergent.
bottle.
①Please check whether the pure
water machine operate normally.②
Please check whether there are no
obstacles in hose (inside/outside)
13 There is no pure water in pure water tank.
for connection between pure water
machine and pure water tank.
③If the problem doesn't solve,
①Please discard waste liquid.
14 Waste tank is full. ②If there is no waste liquid,
①Please discard waste liquid.
15 Separate Collection Reservoir is full. ②If there is no waste liquid,
16 There is no sample. Please add or change the sample.
Please add or change reagent 1
17 There is no reagent 1. depending on [Item Name] of error
list.
Please add or change reagent 2
18 There is no reagent 2. depending on [Item Name] of error
list.
①Please wipe off overflowed water.
②If there are some obstacles in
waste liquid line, please remove
the obstacles. If waste liquid
①There are some obstacles in waste liquid line
line is bent, please mend the line.
or waste liquid line is bent.
19 If the problem does not solve,
②DP has some problems or is broken.
③CWP has some problems or is broken.
③If there is no problem in waste
liquid line, please call our
service division with keeping the
machine OFF.
The machine wash the probe
automatically. After washing, if
The inside of sample probe might be clogged up
20 jams are solved, "Recovery" message
with fibrin。
is shown. If jams are not solved,
"Big problem" message is shown.
Jams were solved as result of
21 Jams of sample probe were solved.
washing.
①Please clean the inside of the
The machine washed the probe automatically. probe by nylon wire.
22
However jams were not solved. ②If jams are not solved, please
call our service division.
6-12
Ref
No.
Cause Solution
①Please check room temperature.
②If the message is displayed
23 The temperature of RCT is abnormal.
easily, please call our service
division.
①Please check room temperature.
②If the message is displayed
24 The temperature of WSH is abnormal.
easily, please call our service
division.
①Please check whether pure water
machine works normally.
②Please check whether pure water
is full in pure water tank.
③Please check whether there is no
25 There may be no water in WSH.
air in tube connected to CWS. If
there is air in tube, please
reconnect the tube.
④If the problem is not solved,
The machine tried to check reagent remaining in After "ready", please operate
26
the state that was not "ready". reagent remaining check.
There is position problem about reagent 1
27 Please check round information.
position of round setting.
There is position problem about reagent 2
position of round setting.
There is position problem about hemolysis agent
of round setting.
①Please restart PC and the
PC cannot transmit information to the machine
machine.
30 from a PC and information may overflow in the
②If it seems to occur frequently,
machine side.
①If there are causes between PC and
the machine, please remove the
A communication between PC and the machine is causes.
31
impossible by noises. ②Please change the cable.
③If it seems to occur frequently,
Measurement is impossible. Causes are
①Please check parameter input.
following.
32 ②If the problem does not solve,
①PCB may be broken.
②There is a problem in parameter input.
A kind of calibration is
Calibration data and a kind of calibration of mismatched. As this is a system
33
item parameter are different. problem, please call our service
division.
Please check the round setting.
There is no data in round information which PC
34 Please check whether reagents are
tried to calculate a result of calibration.
registered correctly.
Number of characters is abnormal. (too long or Number of characters is mismatched.
35
too short) Please recreate the bar-code.
6-13
V5.7
Ref
No.
Cause Solution
It is impossible to read a bar-code because of
36 Please recreate the bar-code.
a problem of bar-code.
Please check whether the bar-code
37 A bar-code is not affixed.
is affixed in primary tube.
Please put a cup or a primary tube
38 A cup is not put.
in Sampler.
There might be a request in position which the
39 machine is analyzing. (Only at the time of online Please check a request from host PC.
communication).
①Please do Auto-gain again.
②If the problem does not solve,
40 Absorbance is too low. （C mark）。
please replace the lamp with new
one.
Check reaction monitor. Judging
from absorbance value, select a
Absorbance of measurement is out of calibration solution from the following and run
41
range of standard sample (V flag). the process.
①Dilute and rerun.
②Rerun without dilute.
①Check position of calibrator.
②Check "Calibration CV (%)" in
Serious difference between previous result and
42 "Configuration" screen. If the
current result.
value is small, input 20-30.
③Draw calibration again.
①Do Auto-gain again.
43 Absorbance is high (too dark). Lamp may be out. ②If the problem is not solved,
change the lamp to new one.
44 Abnormality of calculation item.
This is calculation error. Check
45 Abnormality of calculation item. the following points.
① Result value of each item.
46 Abnormality of calculation item. (Check reaction procedure whether
reaction is correct seeing reaction
There is no item for calculation in calibration
47 monitor.)
file.
② Parameter of calculation item.
48 Abnormality of calculation item. （Whether value is input
correctly.）
49 There is no item information. After checking above two points,
rerun.
50 There is no specimen kind.
There is no item in item parameter against
Cancel request from host. Check
51 request from host. Which host requested in item
item parameter.
parameter.
52 There is no item which is able to measure. Check remain of reagent.
After checking of reagent
There is no item in Calib and Round against
53 information and round setting, draw
request from host.
calibration again.
6-14
Ref
No.
Cause Solution
It is impossible to measure because of short of Remaining amount of reagent is
54
test count. nothing. Add reagent.
55 Reagent expired. Change reagent.
56 Power has been turned OFF. Check power of analyzer.
Abnormality of communication data from
57
analyzer.
58
analyzer.
Check cable between analyzer and
59 No response from analyzer.
PC. MCPU PCB may be broken. If the
Abnormality of communication data from problem is not solved, please call
60
analyzer. our service division.
61
analyzer.
Communication error occurs at measurement
61’
result messages while measurement.
Other software uses the port.
Check the following two points.
①Restart PC and start up only
62 Serial port has not been opened. analyzer software.
②Check port number on device
manager in Windows and correspond
the number with analyzer.
63 Printer has been turned OFF. Turn ON printer.
64 In case of the skip cells are above 20. Please change cells.
Conversion from external representation to
This is system error. Please call
65 internal representation is impossible. （ LAN
our service division.
transfer）
Please prepare new Lamp. Please
66 The exchange time of Lamp approaches.
change it as soon as a lamp is OFF.
Please check the error code ins ISE
67 There are some problem during measurement. error code list.
（Please see ISE error code list)
You may have measured other sample except urine, Please check sample type in sample
68
serum, dialysis. order screen.
The urine calibration parameter is an error
69 which was sent to the ISE unit after the system Please calibrate urine.
start.
Please change Na electrode and
70 The lifetime of Na electrode is expired. change the date in ISE maintenance
screen.
Please change K electrode and
71 The lifetime of K electrode is expired. change the date in ISE maintenance
screen.
Please change Cl electrode and
72 The lifetime of Cl electrode is expired. change the date in ISE maintenance
screen.
Please change Ref electrode and
73 The lifetime of Ref electrode is expired. change the date in ISE maintenance
screen.
6-15
V5.7
Ref
No.
Cause Solution
Please change ISE pump and change
74 The lifetime of ISE pump is expired.
the date in ISE maintenance screen.
This message is displayed when the data was not After finishing of ISE movement,
75
able to send to ISE unit. please do "Ready" again.
The exchange time of the Na electrode
76 Please prepare new Na electrode.
approaches.
77 The exchange time of the K electrode approaches. Please prepare new K electrode.
The exchange time of the Cl electrode
78 Please prepare new Cl electrode.
approaches.
The exchange time of the Ref electrode
79 Please prepare new Ref electrode.
approaches.
80 The exchange time of the Calibrator1 approaches. Please prepare new Calibrator1.
81 The exchange time of the Calibrator2 approaches. Please prepare new Calibrator2.
82 ASTM communication open error
83 ASTM communication breakdown
84 ASTM - Send message unable
85 ASTM - Timeout
86 ASTM - NAK received
87 ASTM - Over record length
88 ASTM - Measurement request registration error
ASTM - Requested sample is during measurement or
89
completed the measurement
90 ASTM - Position error
91 ASTM - No request specified Contact your host software company.
92 ASTM - No Patient information
93 ASTM - Item error
94 ASTM - Abnormal message error
95 ASTM - Position check error
96 ASTM - Short field
97 ASTM - Delimiter split error in message
98 ASTM - Existence check error
99 ASTM - Lens check error
100 ASTM - Value check error
101 ASTM - Retry over
You may have washed the ISE despite not the
102 Please do "Ready" and wash the ISE.
"Ready".
You may have calibrate ISE despite not the Please do "Ready" and calibrate the
103
"Ready". ISE.
①Please do "Ready".
②Once turn OFF the PC and the
104 ISE probe is not able to go back to home position. analyzer and then turn ON again.
③If the problem is not solved,
After finish in purge or
105 ISE automatically purges or maintains.
maintenance, please retry.
Check cup set position. Set cup in
106 There is no cup in designated position.
correct position.
6-16
Ref
No.
Cause Solution
107 You may have operate a motor which is undefined.
Designated position error of motor movement
108 Please call our service division.
table.
109 Index error of motor movement table.
Please wait until ISE movement
finish.
110 The communication with ISE unit is impossible. After finishing the movement,
please do "Ready" and check whether
ISE unit move correctly.
Default setting of sample barcode reader has not There are some problems in a cable
111
been succeeded. connected with sample barcode
Default setting of reagent barcode reader has reader.
112
not been succeeded. Please call our service division.
The causes are as following.
113
②The line between level sensor and PCB has been
broken.
114
broken. MCPU PCB may be broken.
The causes are as following. Please call our service division.
115
broken.
116
broken.
117 System error of MCPU
118 System error of MCPU MCPU PCB may be broken.
119 System error of MCPU Please call our service division.
120 System error of MCPU
6-17
V5.7
6.5 ISE error code list
Error Ref.
No. Code
Contents No.
In measurement of sample or 1
1 100000 Noise error of Na electrode ：
calibrator2
In measurement of sample or
2 200000 Noise error of K electrode ：
calibrator2
3 300000 Noise error of Na, K electrodes ：
calibrator2
4 400000 Noise error of Cl electrode ：
calibrator2
5 500000 Noise error of Na, Cl electrodes ：
calibrator2
6 600000 Noise error of K, Cl electrodes ：
calibrator2
7 700000 Noise error of Na, K, Cl electrodes ：
calibrator2
8 S00000 Air detection at flow sensor ： In measurement of sample 2
In measurement of
9 B00000 Air detection at flow sensor ：
Calibrator2
In measurement of sample or 3
10 E00000 Poor drainage detection at flow sensor ：
Calibrator2
In measurement of 4
11 010000 Noise error of Na electrode ：
Calibrator1
In measurement of
12 020000 Noise error of K electrode ：
Calibrator1
In measurement of
13 030000 Noise error of Na, K electrodes ：
Calibrator1
In measurement of
14 040000 Noise error of Cl electrode ：
Calibrator1
In measurement of
15 050000 Noise error of Na, Cl electrodes ：
Calibrator1
In measurement of
16 060000 Noise error of K, Cl electrodes ：
Calibrator1
In measurement of
17 070000 Noise error of Na, K, Cl electrodes ：
Calibrator1
In measurement of 5
18 0A0000 Air detection at flow sensor ：
Calibrator1
In measurement of 6
19 0E0000 Poor drainage detection at flow sensor ：
Calibrator1
In measurement of 7
20 001000 Potential drift error at Na electrode ：
Calibrator1
In measurement of
21 002000 Potential drift error at K electrode ：
Calibrator1
Potential drift error at Na, K In measurement of
22 003000 ：
electrodes Calibrator1
In measurement of
23 004000 Potential drift error at Cl electrode ：
Calibrator1
6-18
Error Ref.
No. Code
Contents No.
Potential drift error at Na, Cl In measurement of 7
24 005000 ：
In measurement of
25 006000 Potential drift error at K, Cl electrodes ：
Calibrator1
Potential drift error at Na, K, Cl In measurement of
26 007000 ：
27 000100 Potential overshooting of Na electrode ： (OUT OF RANGE) 8
28 000200 Potential overshooting of K electrode ： (OUT OF RANGE)
Potential overshooting of Na, K
29 000300 ： (OUT OF RANGE)
electrodes
30 000400 Potential overshooting of Cl electrode ： (OUT OF RANGE)
Potential overshooting of Na, Cl
31 000500 ： (OUT OF RANGE)
electrodes
Potential overshooting of K, Cl
32 000600 ： (OUT OF RANGE)
electrodes
Potential overshooting of Na, K, Cl 9
33 000700 ： (OUT OF RANGE)
electrodes
(Out of slope range, slope 10
34 000010 Calibration slope error of Na electrode ：
drift)
(Out of slope range, slope
35 000020 Calibration slope error of K electrode ：
drift)
Calibration slop error of Na, K (Out of slope range, slope
36 000030 ：
electrodes drift)
(Out of slope range, slope
37 000040 Calibration slope error of Cl electrode ：
drift)
Calibration slope error of Na, Cl (Out of slope range, slope
38 000050 ：
electrodes drift)
Calibration slope error of K, Cl (Out of slope range, slope
39 000060 ：
electrodes drift)
Calibration slope error of Na, K, Cl (Out of slope range, slope
40 000070 ：
electrodes drift)
Pulse over error of return movement to 11
41 000001
home position (nozzle X axis)
Pulse over error of return movement to 12
42 000002
home position (nozzle Z axis)
Timeout error of movement (nozzle X 11
43 000003
axis)
Timeout error of movement (nozzle Z 12
44 000004
axis)
45 000007 Not movement error of nozzle X axis 13
46 000008 IC error of pulse motor controller 14
47 000009 IC error of pulse motor driver
48 00000N Samp_OK Timeout error 15
6-19
V5.7
6.6 ISE error causes and solutions
Ref
No.
Error code Causes Solutions
1 100000 Air bubble in sample line Make sure there is enough sample in cup.
200000 Confirm positioning of sampling probe and
300000 sample cup.
400000 Poor L-GND function Wipe off inside of L-GND pipe by thread.
500000 If the above action is not effective, change
600000 L-GND pipe.
700000 Dirty sample tube Clean sample tube by ISE cleaning solution,
(Propagation of noise) supplied from us. If above cleaning is not
effective, replace sample tube with new one.
Dirty drainage tube Exchange drainage tubes with a new tube.
If drainage trough is dirty, clean up the trough
thoroughly.
Electrode is damaged. If error occurs for particular items such as
100000, 200000, 400000, replace with the new
corresponding electrode.
If error occurs for all items (700000), replace
with new Reference electrode.
Drying of the electrode If the electrodes are dry, it takes time to
recover.
If recovery is impossible during 1-2 hours,
please change the electrodes.
2 S00000 No sample or short of Make sure if there is enough sample in cup.
B00000 sample Make sure if sampling nozzle is clogging.
Check Cal-2 residual volume in the bag. If
the volume is too small, replace it with new
bag.
Pump tube degradation cause Replace pump tube with new one.
poor liquid transfer Change pump tube.
Pinch valve tube degradation Replace pinch valve tube with new one.
cause poor liquid transfer. Change pinch valve tube.
Liquid flow line clogging If sampling nozzle or electrode inlet is clogged,
clean using fishing line or mandolin string.
Make sure if piping tube is crushed.
If piping tube is clogging, change tube.
Poor electrode setting Reset electrode.

Dismantle electrodes once and set them back.
If any liquid leakage occurs, wipe away them
thoroughly.
Flow sensor is not working To recover flow sensor function, do the
properly. following action.
Exceed command <PURG>, and do air level
setting. Clean inlet and outlet holes of flow
sensor using thread.
6-20
Ref
No.
2 S00000 Flow sensor is damaged. Change a flow sensor or sensors.

B00000 Poor electric conductivity. Pull out connectors of pump and pinch valves,
and insert them again.
Peristaltic pump is not working If roller holder fixing screws are loosen,
properly. tighten them.
Malfunction of pinch valve If the above action is not effective replace
pump itself.
Change pinch valve.
3 E00000 Pump tube degradation cause Replace pump tube with new one.
poor liquid transfer
Pinch valve tube degradation Replace pinch valve tube with new one.
cause poor liquid transfer.
Flow line clogging If sampling nozzle or electrode inlet is clogged,
clean it using fishing line or mandolin string.

Dismantle and reset electrodes carefully. If
any liquid leakage occurs, wipe away them
thoroughly.
properly. following action.
Click "PURGE" button, and do air level
setting. Clean inlet and outlet holes of flow
sensor using thread.
Flow sensor is damaged Change a flow sensor or sensors.
Poor electric contact Pull out connectors of pump and pinch valve
once and re-insert again.
Peristaltic pump has trouble. If roller holder fixing screws are loosen,
tighten them.
If the above action is not effective replace
pump itself.
Pinch valve is not working. Replace pinch valve with new one.
4 010000 Air bubble in Cal-1 tube Check Cal-1 volume in the bag.
020000 If the volume is too small, replace it. If there
030000 is an air bubble in Cal-1 tube, perform
040000 <PURG>.
050000
Poor L-GND function Clean inside of L-GND pipe by a string.
060000
If it is not effective, replace L-GND pipe.
070000
Dirty sample tube If cleaning by proper cleaning solution is not
(Propagation of noise) effective, replace sample tube.
Dirty drainage tube Exchange drainage tubes.
(Propagation of noise) When waste liquid trough of analyzer is
contaminated, clean it.
6-21
V5.7
Ref
No.
4 010000 Defective or degraded electrode If error occurs for particular items like 01000,
020000 02000, 04000, change the electrode.
030000 If error occurs for all items (07000), change
040000 Reference electrode.
050000
Dried electrode Once electrode is dried, it takes a couple of
060000
hours to recover. Wait 1 to 2 hours, and try it
070000
again.
If it is not successful, replace electrode.
5 0A0000 Check if Cal-1 bag is connected. If not
No Cal-1 bag or short
connect it. Check Cal-1 volume in the bag.
Cal-1 volume in the bag.
If the volume is too small, replace it.
Short sample, caused by pump
Trial pump tube replacement.
tube degradation
Short sample, caused by pinch
Trial pinch valve tube replacement
valve tube degradation
Liquid flow line clogging
If sampling nozzle or electrode inlet is clogged,
Poor electrode setting Dismantle and reset electrodes carefully.

If any liquid leakage occurs, wipe away them
thoroughly.
properly. following action. Exceed command <PURG>,
and do air level setting.
Clean inlet and outlet holes of flow sensor
using Thread.
Flow sensor is damaged. Change a flow sensor or sensors.
Poor connector electric Pull out connectors of pump and pinch valves,
conductivity. and insert them again.
Peristaltic pump has trouble. If roller fixing screws are loosen, tighten them.
If the above action is not effective replace
pump itself.
Pinch valve has trouble. Replace pinch valve.
6 0E0000 Pump tube degradation cause Change pump tube.
poor liquid transfer.
Pinch valve tube degradation Change pinch valve tube.
cause poor liquid transfer.
Flow line clogging If sampling nozzle or electrode inlet is clogged,

Dismantle and reset electrodes carefully. If
any liquid leakage occurs, wipe away them
thoroughly.
6-22
Ref
No.
6 0E000 Flow sensor is not Working To recover flow sensor function, do the
properly. following action. Exceed command <PURG>,
and do air level setting.
Clean inlet and outlet holes of flow sensor
using thread.
Flow sensor is damaged Change a flow sensor or sensors.
Or change tube of flow sensor and reagent pot.
Poor connector electric Pull out connectors of pump and pinch valves,
conductivity. and insert them again.
Peristaltic pump has trouble. Change roller pump.
If roller bearing fixing screws are loosen,
tighten them. If the above action is not
effective replace pump
Pinch valve is not working. Replace pinch valve itself.
7 001000 Bubble in Cal-1 If there is not enough Cal-1, change Cal-1.
002000 If there is bubble in Cal-1 tube, perform
003000 <PURG>.
004000 Poor electrode function Clean electrode using proper cleaning
005000 solution, supplied from us.
006000
007000 Defective or degraded electrode If error occurs for particular items like
001000, 002000, 004000, change the electrode.
If error occurs for all items (007000), change
Re electrode.
Dried electrode Once electrode is dried, it takes a couple of
hours to recover.
Wait 1 to 2 hours, and try it again. If it is not
successful, replace electrode.
Poor L-GND function Clean inside of L-GND pipe by a thread.
If it is not effective, replace L-GND pipe.
Unstable temperature Do not use Cal-1, which is just taken out from
refrigerator. Leave it to be room
temperature.
Do not operate analyzer when the room
temperature or analyzer temperature are
changing rapidly.
8 000100 Air bubble in sample line Make sure there is enough sample in cup.
000200 Confirm positioning of sampling probe and
000300 sample cup.
000400 Check sample level in the sample cup. Check
000500 if sample probe tip goes down into sample
000600 surly.
000700
Air bubble in Cal-1 line Check Cal-1 volume in the bag. If the
residual volume is too small, replace the bag.
If you find an air bubble in Cal-1 line, perform
<PURG>.
6-23
V5.7
Ref
No.
8 000100 Defective or degraded If error occurs for particular items like

000200 electrode 000100, 000200, 000400, change the electrode.
000300 If error occurs for all items (000700), change
000400 Ref electrode.
000500
Poor contact between electrode Dismantle electrode and check electric
000600
and board contact.
000700
Check If spring probe is pushed down.
Check if rust is on the contacting pin.
Analog circuit board trouble Change control board or unit.
9 00700 Bubble in passage joint of Ref Remove bubble at Ref electrode.
electrode Refer to Chapter5, 5.2.10-9.Removal of bubble
at Ref electrode setting.
10 000010 Degradation of calibrator Confirm shelf life of calibrators. If shelf life
000020 is over, replace calibrator.
000030 Degradation of Liquid Ground Wipe off an inside of L-GND pipe by thread.
000040 If there is no improvement, change L-GND.
000050 Plumbing Check the plumbing of calibrator1 and 2. If
000060 the plumbing is reverse, repair the plumbing.
000070 Defective or degraded If error occurs for particular items like
electrode 000010, 000020, 000040, change the electrode.
Unstable temperature Do not use Cal-1, which is just taken out from
refrigerator. Leave it to be room
temperature.
Do not operate analyzer when the room
temperature or analyzer temperature are
changing rapidly.
11 000001 Obstacles for sample probe Check if something (tube or cable etc.) is
000003 movement disturbing sample probe horizontal
movement.
Sample probe vertical home Replace sample probe home position sensor for
position sensor is not working. vertical movement.
12 000002 Obstacles for sample probe Check if something (tube or cable etc.) is
000004 movement disturbing sample probe vertical movement.
Stain If screw axis of nozzle unit is dirty, please
Paper wiper off the dirt and put some grease.
Sample probe horizontal home Replace sample probe home position sensor for
position sensor is not working. horizontal movement.
13 000007 Unstable stopping position of Check if timing belt is loosen. If it is so,
sample probe. tighten it.
14 000008 Erroneous action of motor Turn off ISE power switch once and turn on it
000009 driver IC. again.
If above action is not successful, replace Motor
driver PCB.
15 Poor PIC cable connection Confirm the state of PIO cable connection
00000N between analyzer and ISE unit.
Analyzer side trouble Check any trouble is occurring in analyzer
side, such as sample table is stopping
in-proper position.
Broken control PCB Replace control PCB.
6-24
6.7 ISE other errors
Symptom Causes Solutions
Green LED of 5V power is not supplied.

Check a cable and a connector.
control PCB is not （ Poor connect or damage of
Change ISE unit or driver PCB.
working. driver PCB）
Power supply is less than Check a cable and a connector.

Red LED of 4.65V （Reset state） Change ISE unit or power supply
control PCB is *Poor connect or damage of SW part.
working. regulator Dismantle ROM once and set it
Poor connect of ROM back.（Direction attention）
Not working
Power on LED 24V power is not supplied. Check a cable and connector.
(green) of pump （Poor connect of power supply Change ISE unit or power supply
part is not part） part.
working. Disconnection of fuse Change fuse on driver PCB.
Check communication cable

Communication with analyzer （If you dismantle communication
is unable cable, don't forget to turn off the
Other analyzer.)
Cable of drive system is not
Check cable and connector.
connect.
Damage of PCB Change PCB and unit
Often reset.
Supply voltage is instability. Check cable and connector.
（ Often initialize mo
Change ISE unit or driver PCB.
vement）
Maintenance mode has not Press "MAINT cancel" button for
been released. release of maintenance mode.
If drainage error happens, the

Auto calibration and analyzer automatically move to
auto purge is not maintenance mode.
working. Drainage error happens
After solve the drainage error, press
"MAINT cancel" button for release
of maintenance mode.
Result become 0
Calibration is not finished. Do calibration.
without error.
6-25
V5.7
Symptom Causes Solutions
Clean by dedicated cleaning

Dirty flow tube
Poor reproducibility solution.
Clean by dedicated cleaning
Dirty electrode
solution.
Wipe off inside of pipe of L-GND by
paper string.
Poor L-GND
If the action is not effective replace
L-GND.
Dismantle and reset electrodes
Poor electrode setting
carefully.
Dirty of sample probe.
Clean the nozzle.
Sampling nozzle and reagent
Adjust position.
pot.
Check expire date and then change
Deterioration of calibrator
Accuracy is not correct. calibrator.
Calibration is not finished. Do calibration.
Poor electrode Change electrode.

Wipe off inside of pipe of L-GND by
paper string.
Poor L-GND
If the action is not effective replace
L-GND.
If wrong correction factor is input,

change the correction factor.
Correction factor is not correct.
After maintenance, correct by
standard substance.
It is possible that control serum

Measurement result of
contains bad influence substance
control serum is
Influence of interference ion. (antiseptic etc.).
different from displayed
To confirm accuracy, check by
value.
standard serum.
6-26
V5.7
Main Consumables List
Packing
Code Parts Name Remarks
Qty.
50-24-0747 Alkaline Washing Solution 2.5D (1000mL) 4
50-24-0748 Acid Washing Solution 5D (1000mL) 4
SP2057 Lamp Assy 1
50-09-0262 CUVETTE (90pcs/SET) 90
20-27-0477F Calibrator 1F (420mL) 1
30-27-0905F Calibrator 2 (140mL) 1
50-27-0781F ISE CLEANER(25ml) 1% 1
50-27-0782F ISE CLEANER(25ml) 5% 1
20-27-0474F Na Electrode F 1
20-27-0475F For ISE K Electrode F 1
20-27-0476F Cl Electrode F 1
20-27-0473F Reference Electrodes F 1
50-27-0783 Roller Pump Tube B（3 Pieces） 3
50-27-0786 Pinch valve tube 1
30-27-0910 Piping Tube 1
20-27-0490 Electrodes O-Ring 1
20-22-0391 Sample Cup (1000 Pieces) 1000
20-30-0587 Small Amount Sample Cup (1000 Pieces) 1000
Spare-Parts List of Annual Maintenance
Packing
Code Parts Name Remarks
Qty.
50-24-0722 Reagent Bottle（70ml) (10 Pieces) with Cap 10
50-24-0723 Reagent Bottle（20ml) (10 Pieces) with Cap 10
50-10-0326 Mixing Stirrer 1
50-02-0087 Sample Probe 1
50-03-0106 Reagent Probe 1
50-27-0818 Dummy electrode 1
SP2070 φ14 U Packing with O-ring 1
50-13-0384 Drying Nozzle (2pieces/set) 2
50-17-0451 Drain pump (DP) unit 1 Recommended

Periodic Check List
◎ Periodic Check List (for customer)
Contents Dairy Week 3mth 1 yr If need Remarks
Check of the volume and

1 ○
purity of pure water machine
Check of the volume
2 ○
detergent tank
3 Cleaning of sample probe ○
Cleaning of sample probe for
4 ○
ISE
5 Cleaning of reagent probe ○
Check of the keeping reagent
6 ○
tray cool
7 Cleaning of the stirrer ○
Cleaning and check of the
8 ○
strain of the cell cover
Priming of washing pot for
9 ○
ISE sampling probe.
Cleaning of the ISE sample
10 ○ ISE Wash
line.
Washing
11 All Washing ○
Probe,Cell,Stirrer
Washing
12 Special Washing ○ ○
Probe,Cell,Stirrer
Cleaning of washing pot for
13 ○
ISE sampling probe.
14 Cleaning of cooling filter. ○
Exchange of Cal-1 pack for
15 ○
ISE
Exchange of Cal-2 pack for
16 ○
ISE
Exchange of pump tubes for
17 ○ 〇
ISE
18 Exchange of Na electrode ○
19 Exchange of K electrode ○
20 Exchange of Cl electrode ○
Exchange of Pinch Valve
21 ○
Tube for ISE
22 Exchange of Ref electrode ○
Exchange of light source
23 ○
lamp
24 Exchange of reaction cells ○
25 Air trap liquid level check ○
V5.7
◎ Periodic Check List (for service engineer)
Contents 6 mth 1 yr If need Remarks
1 Cleaning of the washing pot of sample probe ○

Cleaning of the washing pot of reagent probe(R1,
2 ○ ○
R2)
3 Cleaning of the washing pot of stirrer.(M1,M2) ○ ○
4 Check of movement in reaction tray. ○ ○
5 Cleaning inside of sample pumps for SP. ○
6 Applying of silicon oil to plungers for SP ○ ○
7 Exchange of U-packing for SP ○
8 Cleaning inside of pumps for RP ○
9 Applying of silicon oil to plungers for RP ○ ○
10 Exchange of U-packing for RP ○
11 Cleaning inside of pumps for PWP ○
12 Applying of silicon oil to plungers for PWP ○ ○
13 Exchange of U-packing for PWP ○
14 Cleaning of reagent tray and dust filter ○ ○
15 Check of the movement of MU(stirrer) ○ ○
16 Check of the movement of EV ○ ○
17 Check of the movement of WSH (water leak) ○ ○
18 Check of the temperature control of WSH ○ ○
19 Check of movement for DP ○ ○
20 Check of degasser (Consumable) ○ ○
21 Check of the liquid leak of the body ○ ○
22 Cleaning of body ○ ○
23 Exchange of the piping ○
24 Exchange of the ISE piping ○
Perform it by the
25 Exchange of house in pure water machine ○
dirt degree
26 Exchange of Drain pump(DP) unit ○ Recommended
27 Check and cleaning of air trap ○
28 Movement check of detergent pump(Clog) ○
Confirmation of joint leakage and cooling
29 ○ ○
condition of RGT cooling tank
Operator’s Manual, Version 5.7
Apr. 1, 2020
Printed in Japan

(90-55-3000) BIOLIS 50i - Operator's M - V5.7 PDF

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Automated Clinical Analyzer

TOKYO BOEKI MEDISYS INC.

We appreciate your adoption of our Automated Clinical Analyzer.

Manufactured by Tokyo Boeki Medisys Inc.

・Modification for the analyzer

Addition of an attachment, supplied from the other maker than us.

・Self-repair or parts replacement

Self-adjustment of the points, assigned as qualified service engineer only.

© Copyright 2011 Tokyo Boeki Medisys Inc.

This product meets the requirements of CSA.

Software license agreement

1 The right to use

5 Guarantee and responsibility limit

usage of consented software or related action. Also we have no responsibility on the

6.2 The action violating the law and regulation.

6.6 The action of publish or transmitting false information or information leading to

6.7 The action contrary to other public order and morals.

8 Cancellation of the agreement

9 The action after the agreement has over

Date of revision : Jan. 30th, 2015

Safety Data Sheet

Signal word : Warning

6. Accidental Release Measures

7. Handling and Storage

8. Exposure Control/Personal Protection

9. Physical and Chemical Properties

10. Stability and Reactivity

11. Toxicological Information

12. Ecological Information

13. Disposal Considerations

14. Transport Information

15. Regulatory Information

16. Other Information/References

A boutthe lim iting of the responsibility:

D ate of revision : J an. 29 th, 2015

S afety D ata S heet

S ignal w ord : W arning

3. C om position/I nfor mation on I ngr edients

6. Accidental Release Measures

7. Handling and Storage

8. Exposure Control/Personal Protection

Indiv idual protection measures

9. P hy sical and C hem ical P r oper ties

10. S tability and R eactiv ity

11. T ox icological I nfor m ation

12. E cological I nfor mation

13. D isposal C onsider ations

14. T r anspor t I nfor mation

15. R egulator y I nfor m ation

16.O ther Inform ation/R eferences

About the limiting of the responsibility:

Multi-items automatic analyzer is an analyzer designed as laboratory use bio-sample

This operation manual is composed of the following contents.

Chapter2 [Function and principal]

Chapter3 [Analysis operation]

Chapter4 [Screens and Programming]

Chapter6 [Check Flag・Alarm Function]

1. Expression of Warning and Notice

Note ：Pay attention, additional explanation.

Description of the mark

：This mark means electric shock if touched.

：This mark means high temperature. Keep out from burn.

：This mark means do not touch with wet hand.