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XP series
XP-300
Instructions for Use
CHAPTER 1 Introduction
CHAPTER 2 Safety Information
CHAPTER 3 Design and Function
CHAPTER 4 Reagents
CHAPTER 5 Initial Operation
CHAPTER 6 Operation
CHAPTER 7 Sample Analysis
CHAPTER 8 Display and Output of Analysis Results
CHAPTER 9 Quality Control
CHAPTER 10 Calibration
CHAPTER 11 Instrument Setup
CHAPTER 12 Cleaning and Maintenance
CHAPTER 13 Troubleshooting
CHAPTER 14 Technical Information
Index
KOBE, JAPAN
Table of Contents
1. Introduction ..................................................... 1-1
1.1 Intended use ...................................................................... 1-3
1.2 Symbols used in this manual ............................................. 1-3
1.3 Trademarks ....................................................................... 1-4
1.4 Abbreviations and units used throughout this manual ....... 1-4
Sysmex XP-300 I
Table of Contents
6. Operation ..........................................................6-1
6.1 Screen display ................................................................... 6-1
6.2 Menu tree ........................................................................... 6-5
6.3 Signal tones ....................................................................... 6-6
6.4 Pneumatic unit stop function .............................................. 6-6
6.5 Timer functions .................................................................. 6-7
6.6 Emergency stop procedure ................................................ 6-7
6.7 SNCS functions ................................................................. 6-7
II Sysmex XP-300
Table of Contents
Index
Revised January 2017
IV Sysmex XP-300
Introduction
1. Introduction
Thank you for purchasing the Sysmex XP-300 Automated
Hematology Analyzer.
Before operating this instrument, carefully read this manual.
Keep this manual for further reference.
The XP-300 is a compact instrument, which is designed for easy
operation. For each operating step, the user can adapt the instrument
to his/her needs or existing laboratory conditions by selecting the
appropriate settings. The instrument can also be connected to a host
computer etc., and can be used as one instrument in an analytical
system.
Analysis is possible in whole blood mode as well as in pre-diluted
mode. For this reason, the XP-300 can also be used with a minute
amount of blood (Minimum required volume: 20 L when analyzing
in pre-diluted mode).
The XP-300 performs a reliable analysis of 20 parameters and
displays analysis results in 3 histograms on the LCD screen. In
addition, the analysis data can be printed on the internal/external
printer.
Note:
• Data generated by the XP-300 is not intended to replace
professional judgment in the determination of a diagnosis
or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test
results cannot be guaranteed if there are any deviations
from the instructions in this manual. If the instrument fails
to function properly as a result of either the user’s operation
not specified in the manual or the user’s utilization of a
program not specified by Sysmex, the product warranty
would not apply.
Revised January 2017
Contact address
Training courses
For further training information, please contact your Sysmex
representative.
Risk of Infection
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in infection by pathogens and others.
Warning!
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in death or serious injury to the operator, or
grave property damage.
Caution, Hot!
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in personal injury, such as a burn, to the operator.
Caution!
If this sign is ignored and the instrument is operated
incorrectly, a potentially hazardous situation could
result in injury to the operator, adverse effect on
analysis results or property damage.
Information
Indicates what you need to know in order to maintain
instrument performance and prevent damage.
Note:
Indicates information which will be useful in operating the
instrument.
1.3 Trademarks
Sysmex, EIGHTCHECK, CELLCLEAN, CELLPACK,
STROMATOLYSER and SNCS (Sysmex Network
Communication System) are registered trademarks of
SYSMEX CORPORATION.
ETHERNET is a registered trademark of Xerox Corporation.
ISBT128 (International Society of Blood Transfusion) is
copyrighted by and used under License Agreement with
ICCBBA, Inc.
Other company names and product names in this manual are the
trademarks or registered trademarks of their respective owners. The
fact that a trademark is not explicitly indicated in this manual does
not authorize its use.
TM and ® are not explicitly indicated in this manual.
Abbreviations
Unit
Analysis parameters
This instrument provides results for the following parameters:
WBC: Number of leukocytes (Analysis principle: DC detection
method)
WBC count in 1 L of whole blood
RBC: Number of erythrocytes (Analysis principle: DC
detection method)
RBC count in 1 L of whole blood
HGB: Hemoglobin (Analysis principle: Non-cyanide
hemoglobin analysis method)
Concentration (gram) of hemoglobin in 1 dL of whole blood
HCT: Hematocrit value (Analysis principle: RBC pulse height
detection method)
Ratio (%) of whole RBC volume in whole blood
MCV: Mean RBC volume
Mean RBC volume (fL) in whole blood. The volume is
calculated by HCT/RBC.
MCH: Mean RBC hemoglobin
Mean hemoglobin concentration (pg) per RBC. The
concentration is calculated by HGB/RBC.
MCHC: Mean RBC hemoglobin concentration
Mean hemoglobin concentration (g/dL). The concentration is
calculated by HGB/HCT.
PLT: Platelet (Analysis principle: DC detection method)
Platelet count in 1 L of whole blood
LYM% (W-SCR): WBC-Small Cell Ratio
Ratio (%) of small cells (the lymphocytes) to whole WBC
MXD% (W-MCR): WBC-Middle Cell Ratio
Revised January 2017
2. Safety Information
Before operating this instrument, carefully read “2. Safety
Information” as well as other instructions in this manual.
Warning!
• Keep your hair, fingers and pieces of your clothing
away from the instrument while it is running.
You may get injured by getting them caught in the
instrument.
• Should the instrument emit unusual odors or smoke,
turn the main power switch OFF immediately and
unplug the power cable. Using the instrument any
further bears the risk of fire, electric shock or
personnel injury. Contact your local Sysmex
representative immediately for inspection.
• Should the instrument leak fluid, turn OFF the main
power switch immediately, and unplug the power
cable. Using the instrument any further bears the risk
of short circuit, fire, electrical shock or personnel
injury. Contact your local Sysmex representative for
inspection.
• Do not spill liquids such as blood samples or reagent,
nor put metal objects such as staples or paper clips
on the instrument. This could cause a short-circuit or
smoke. In the event of the instrument failure, turn the
main power switch OFF immediately and unplug the
power cable. Contact your local Sysmex
representative for inspection.
• The operator should not touch any electrical circuitry
inside the cover. The danger of electric shock is
particularly high when one’s hands are wet.
• This instrument must not be connected to a power
outlet rated at anything other than specified in the
rating plate.
Please note that the instrument must be grounded.
Failure to do so may cause a fire or electrical shock.
• Avoid damage to the power cable. Do not place any
appliances on the power cable. Do not pull on the
power cord.
• Turn the power supply OFF before connecting
peripheral devices such as a host computer or
handheld bar code reader.
Information
• Before operating this instrument, carefully read this
Revised January 2017
2.2 Installation
Caution!
• This instrument must be protected against splashing
water.
• Install in places where there are no adverse effects
from high temperature and humidity, dust or direct
sunlight.
• Avoid shock and vibrations.
• The installation location must be well ventilated.
• Avoid installation near devices causing potential
interference, such as wireless communication
equipment or similar devices, and centrifuges.
• Installation of this instrument in places where
chemicals are stored or hazardous gas may be
present is not permitted.
• Avoid installation near devices that are susceptible to
interference, such as personal computer monitors.
• Use the instrument in places where ambient
temperature ranges between 15°C and 30°C
(optimal at 23°C).
• Use the instrument in places where relative humidity
ranges between 30% and 85%.
Note:
Please always run the instrument with the front cover
closed. The instrument does not comply with the standards
mentioned above while the front cover is left open.
Risk of Infection
• In principle, all parts and surfaces of this instrument
must be regarded as potentially infectious, since this
instrument analyzes patient specimens.
• When performing any task on the instrument, such
as testing, maintenance, preparation, or post
processing, be sure to wear adequate personal
protective equipment, such as protective gloves, a
protective mask, protective eyewear, and a lab coat.
Use only specified tools and parts. After work is
completed, wash hands with disinfectant.
• Be sure to connect the instrument's drain tubing to a
waste tank at the facility or waste container.
• Use a waste tank or waste container that has a
nipple to which the drain tubing can be attached or
that has other means of securing the tubing in place
so as to avoid the risk of waste fluid spillage. In
addition, exercise care so as to avoid such spillage,
for example by regularly verifying that the tube
remains properly secured in place.
• If you are using a waste container, check the
contents regularly and replace the container when
full.
• Never touch waste, or parts having been in contact
with waste, with your bare hands.
• Should you inadvertently come in contact with
potentially infectious materials or surfaces,
immediately rinse skin thoroughly with water, and
follow your hospital or laboratory’s prescribed
cleaning and decontamination procedures.
• Control blood must be regarded as potentially
infectious. Wear protective garments and gloves
when performing quality control.
Revised January 2017
Warning!
• If reagents are spilt inadvertently near electrical
cables or appliances, there is a risk of electric shock.
Switch the instrument off, unplug and remove the
liquid.
• CELLCLEAN is a strong alkaline cleaning solution.
Do not mix it with any acidic substances. Also, it
should not come in contact with skin or clothing. If
contact occurs, rinse skin or clothing with plenty of
water to avoid injury or damage, respectively.
• If CELLCLEAN makes contact with the instrument’s
surfaces, it will affect the surface finish and there is
danger of corrosion. Immediately wipe off the
CELLCLEAN with a damp cloth.
Caution!
• Use only the reagents specified in this manual.
• Read the note documentation and labeling on all
reagents.
• Avoid direct contact with reagents. Reagents can
cause irritation of the eyes, skin and mucous
membranes.
• Should you inadvertently come in contact with a
reagent, rinse skin immediately with plenty of water.
• At eye contact, rinse at once with plenty of water and
see a physician.
• If swallowed, seek medical advice immediately.
• Leave the reagent at room temperature (15 - 30°C)
for at least 24 hours before using.
• Avoid contact of dust, dirt or bacteria with the reagent
especially when installing new cubes.
• When reagent is to be stored, store the reagent at
the specified temperature for each reagent.
• Reagents must not be used after their expiration
date.
• Handle reagents gently to avoid bubbling. Do not
shake! Do not use directly after transportation.
• Take sufficient care to prevent the reagent from
spilling. If reagent is spilt, wipe up with a damp cloth.
Revised January 2017
2.6 Maintenance
Risk of Infection
Always wear protective garment and gloves for all
service and maintenance work. Use only specified
tools and parts. After work is completed, wash hands
with disinfectant. Instrument surfaces in contact with
blood is potentially biohazardous.
Caution!
Do not use any organic solvent, acid, or alkaline agent
(except CELLCLEAN that is 1:10 diluted with water).
These will affect the instrument surface's finish and
may cause corrosion or discoloration.
Information
• Do not perform any maintenance work or repair other
than that as specified in this manual.
• When performing out maintenance work, use only
the specified tools and parts. Install only such spare
or replacement parts intended for this equipment.
• Use CELLCLEAN that is 1:10 diluted with water to
clean blood, etc. stained on the instrument surface.
When cleaning the touch panel surface, use a “soft
cloth dampened with ethanol”.
• If the instrument is not operated every day, a “Blank
Error” may occur.
In this case, follow the instructions displayed in the
action message screen.
Revised January 2017
Risk of Infection
To avoid risks of infection, wear protective garments
and gloves for all cleaning or maintenance work. After
completion of work, wash hands with disinfectant.
Otherwise, there is a risk of infection by pathogens.
Warning!
A battery is incorporated in the right side interior of the
instrument in order to keep the stored data. When
disposing of the instrument, remove the battery.
Disposal procedures for batteries should meet the
requirements of all applicable local regulations.
Battery
Waste disposal
Risk of Infection
After becoming waste at end-of-life, this instrument
and its accessories are regarded as infectious. They
are therefore exempted from EU directive 2012/19/EU
(Waste Electrical and Electronic Equipment Directive)
and may not be collected by public recycling to
prevent possible risk of infection of personnel working
at those recycling facilities.
Warning!
• Do not dispose the instrument, accessories and
consumables via public recycling!
• Incineration of contaminated parts is recommended!
Contact your local Sysmex service representative
and receive further instructions for disposal! Follow
local legal requirements at all times.
Caution!
Waste effluents from the instrument may contain
dangerous substances in it and decision about
disposal only has to be made by local water authority.
Decontamination
Warning!
Before decontaminating the instrument, be sure to
turn off the power supply and unplug the power cord.
This is necessary to avoid the risk of electric shock.
When cleaning the instrument, always wear protective
gloves and gown. Also, wash hands after
decontamination carefully with antiseptic solution first
and with soap afterwards. Do not open the instrument
for decontamination inside. This is executed only by
Service Technician.
Information
• To ensure decontamination of the instrument outer
surfaces, clean the instrument surface at the end of
the daily work. This has to be executed in the
following three situations;
- Regularly, at the end of a daily work,
- Immediately, during contamination with potentially
infectious material, and
- In advance of repair or maintenance by the field
technical service representative
• Wipe off the instrument surfaces using a cloth
soaked with a suitable decontamination solution.
Please use one-way cloths, e.g. made of paper or
cellulose. The cloth may be moistened in a way only
that no wetness may reach the inside of the
instrument.
• The indicated residence time of the decontamination
solution shall be observed.
• If required, you may afterwards remove normal
contaminations with commercial neutral detergent, in
case these could not be removed by the
decontaminant.
• As a last step the instrument shall be dried with a dry
one-way cloth.
Revised January 2017
Front
(1)
(1)
Risk of Infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.
Right side
(1)
(1)
Warning!
• This instrument must be grounded.
• To avoid electric shock, disconnect supply before servicing.
• For the continued protection against risk of fire, replace only with fuse of the specified type and
current rating.
• Never open the instrument’s cover on the back when the main power switch is ON. Do not
Revised January 2017
Rear
(1)
(2)
(1)
Risk of Infection
To avoid risks of infection, wear protective garments and gloves for all cleaning or maintenance
work. After completion of work, wash hands with disinfectant. Otherwise, there is a risk of
infection by pathogens.
(2)
Caution!
• Static electricity may damage the electronic circuit via the connectors on the rear panel. Do not
touch connector pins with hands.
• Turn the main power switch OFF before inserting or removing connectors or program cards.
Front interior
(1) (4)
(2)
(1)
Caution!
Confirm that the metal knob is between the stoppers.
If it is not, malfunction will occur.
(2)
Caution!
At instrument installation, remove the SRV fixing screw by turning it counterclockwise and
remove the two spacers. Then, clean the surfaces of fixed and rotary valves. Reassemble the
SRV.
Since the hydraulic lines are rinsed with distilled water before shipment, press the start switch
or the [Auto Rinse] button to wash it down. Upon completion of the instrument sequences,
verify that the background count is within the acceptable limit.
* These protection sheets are removed after installation.
(3)
Risk of Infection
In principle, all parts and surfaces of the instrument must be regarded as potentially infectious.
(4)
Revised November 2017
Caution!
When opening the detector cover to clean the TD aperture, follow the instructions in
“12.12 Clean aperture of TD chamber (drain TD chamber)”.
Because there is a risk of electric shock, do not open this cover for any other purpose.
(5)
Caution, Hot!
The printer head becomes hot. Use caution.
(6)
Caution!
Static electricity may damage the printer head. Do not touch with your hands.
2.9 Operators
Personnel using this instrument must read the Instructions for
Use thoroughly beforehand, and must operate the instrument
correctly.
Personnel who have less experience operating the instrument
should receive guidance and assistance from an experienced
operator.
If the instrument requires service, consult the Instructions for
Use for troubleshooting information. If additional repair is
required, contact your Sysmex technical representative.
Revised January 2017
Warning!
Before replacing the fuse, always turn off the power and disconnect the power cord.
This is to prevent possible electric shocks.
Caution!
For continued protection against risk of fire or smoke, use the fuse of the specified type and
current rating (see the list of provided parts in “5.2 Before installation”).
Information
Avoid turning this switch ON and OFF continuously in short duration. This will overload the fuse
and may cause the fuse to blow.
(2) Regulator
Regulates pressure to 0.05 MPa.
Information
Use only program cards specified by Sysmex.
Risk of Infection
To avoid risks of infection, wear protective garments and gloves for all cleaning or maintenance
work. After completion of work, wash hands with disinfectant. Otherwise, there is a risk of
infection by pathogens.
Revised January 2017
(2) SRV
(1) Detector block
(2) SRV
Makes volumetric measurement of aspirated blood.
Note:
Do no open the instrument cover unless your Sysmex service representative asks you to.
4. Reagents
4.2 CELLPACK
CELLPACK is a diluent used to dilute aspirated analysis samples in
order to measure an RBC count, WBC count, hemoglobin
concentration and platelet count.
Caution!
• Leave CELLPACK at room temperature (15 - 30°C)
for at least 24 hours or longer before using. If a
reagent that has arrived recently is used, a correct
analysis result may not be obtained.
• Use CELLPACK at 15 - 30°C.
When analyzed with reagent of a temperature higher
than 30°C or lower than 15°C, a correct analysis
result may not be obtained.
• Do not allow CELLPACK to freeze.
• CELLPACK is solely intended for use with Sysmex
reagents and analyzers.
• If other reagents are used, the product performance
of Sysmex instruments cannot be guaranteed.
• Do not use any left-over CELLPACK. Always use
new CELLPACK.
• Take care to prevent dust, dirt, bacteria, or other
materials from entering the reagent after it is opened.
Otherwise, there is a possibility that proper analysis
cannot be performed.
• Do not use CELLPACK that shows signs of
contamination or instability, such as turbidity or
discoloration.
Information
Storage and shelf life after first opening
• Store CELLPACK at 1 - 30°C.
• The expiration date is shown on the container.
Revised January 2017
4.3 STROMATOLYSER-WH
STROMATOLYSER-WH is a reagent that lyses RBC for accurate
WBC count determination, WBC tri-modal size distribution analysis
and hemoglobin level measurement.
Caution!
• Leave STROMATOLYSER-WH at room temperature
(15 - 30°C) for at least 24 hours or longer before
using. If a reagent that has arrived recently is used, a
correct analysis result may not be obtained.
• Use STROMATOLYSER-WH at 15 - 30°C.
When analyzed with reagent of a temperature higher
than 30°C or lower than 15°C, a correct analysis
result may not be obtained.
• Do not allow STROMATOLYSER-WH to freeze.
• STROMATOLYSER-WH is solely intended for use
with Sysmex reagents and analyzers.
• If other reagents are used, the product performance
of Sysmex instruments cannot be guaranteed.
• Do not use any left-over STROMATOLYSER-WH.
Always use new STROMATOLYSER-WH.
• Take care to prevent dust, dirt, bacteria, or other
materials from entering the reagent after it is opened.
Otherwise, there is a possibility that proper analysis
cannot be performed.
• Do not use STROMATOLYSER-WH that shows
signs of contamination or instability, such as turbidity
or discoloration.
Information
Storage and shelf life after first opening
• Store STROMATOLYSER-WH at 2 - 35°C.
• The expiration date is shown on the outer packaging.
• Once opened (connected to the instrument), product
stability of the reagent is a maximum of 90 days. In
this case, however, make sure to store
STROMATOLYSER-WH at 2 - 35°C.
Revised January 2017
4.4 CELLCLEAN
CELLCLEAN is a strong alkaline detergent used to remove lyse
reagents, cellular residuals and blood proteins remaining in the
hydraulics of the instrument.
Warning!
• Avoid contact with skin, eyes or clothes.
• In case of skin contact, flush the area with water.
• In case of contact with the eyes, rinse immediately
with large amounts of water and seek medical
attention.
• If swallowed, seek medical advice immediately.
• Because CELLCLEAN is a strong alkaline detergent,
do not mix it with any acidic substances.
• CELLCLEAN is classified as corrosive.
R31: Contact with acids liberates toxic gas.
R35: Causes severe burns.
S26: In case of contact with eyes, rinse immediately
with plenty of water and seek medical advice.
S36/37/39: Wear suitable protective clothing, gloves
and eye/face protection.
S45: In case of accident or if you feel unwell, seek
medical advice immediately (show the label where
possible).
Information
Storage and shelf life after first opening
• Store CELLCLEAN in a dark place at 1 - 30°C.
• The expiration date is shown on the outer packaging.
• Avoid exposure to direct sunlight.
Revised January 2017
4.5 EIGHTCHECK-3WP
EIGHTCHECK-3WP is control blood for testing the precision and
accuracy of hematology analyzers.
Risk of Infection
Always wear protective garments and gloves when
using EIGHTCHECK-3WP. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.
Information
Storage and shelf life after first opening
• Store EIGHTCHECK-3WP in a dark place at 2 - 8°C.
• The expiration date is shown on the reagent’s
packaging.
• Once opened, this reagent should be used within
7 days.
Caution!
Important information about the handling of reagents is noted on their containers or
the package insert. Use the reagents after fully understanding the descriptions.
Xn
Corrosive (Hazardous class in the
Harmful (Hazardous class in the EU)
EU)
Catalogue number
The design of the symbols may differ from the actual product.
Brand name Volume Storage temp. Usage temp. Shelf life after Composition
first opening
CELLPACK 20 L 1 - 30°C 15 - 30°C 60 days Sodium chloride 6.38 g/L
Boric acid 1.0 g/L
10 L Sodium tetraborate 0.2 g/L
EDTA-2K 0.2 g/L
STROMATOLYSER-WH 500 mL×3 2 - 35°C 15 - 30°C 90 days Organic quaternary
ammonium salts 8.5 g/L
Sodium chloride 0.6 g/L
CELLCLEAN 50 mL 1 - 30°C 15 - 30°C – Sodium Hypochlorite
(available chlorine
concentration 5.0%)
5. Initial Operation
5.1 Introduction
This product is an In-vitro diagnostic medical device.
A Sysmex service representative is responsible for unpacking,
installing, and initial setup of the product to ensure its proper and
safe operation.
The next several pages will give some essential information on this
instrument.
Note:
When the connection of a graphic printer (option) to this
instrument is intended, contact your Sysmex service
representative.
Note:
Item No. 4 (973-3041-7 Float Switch No. 23 Assy) is pre-installed in the main unit front interior at the
factory.
Revised January 2017
480
420
355
(5) Remove the pneumatic unit fixing screws (2 pcs). Keep these screws for future use.
Fixing screws
(6) Remove the rubber caps of the reagent connection nipples. Keep these rubber caps for future
use.
(7) Remove the factory-installed protective plate.
Rubber caps
Protective plate
Revised July 2017
Prepare reagent
Caution!
• Take care not to spill reagent on to the instrument. If it spills, wipe it off immediately using a
damp cloth.
• If it comes into contact with your skin, wash it off using plenty of water.
• If a reagent enters your eye, wash it out immediately using plenty of water, and seek medical
treatment at once.
• After unpacking, be sure not to allow dust or dirt to come into the reagent. Use up CELLPACK
within 60 days from the unpacking date, and STROMATOLYSER-WH within 90 days.
Note:
When using the CELLPACK (10 L), a separate cubitainer spout kit is required. Contact your Sysmex
service representative.
Revised January 2017
Connect CELLPACK
Information
Cut the tube to an appropriate length, and connect it. When the diluent (CELLPACK) tube is
more than 2 m long, it may be impossible to have reagent aspirated.
(2) Connect CELLPACK inlet aspiration nipple behind the unit and the nipple of the cubitainer
spout kit No. 1 with the tube polyurethane.
(3) Set the cubitainer spout kit No. 1 to the CELLPACK container.
Cap
Tube polyurethane 4 mm ID × 6 mm OD
CELLPACK
Information
Revised January 2017
• Avoid setting the diluent (CELLPACK) at a level higher than the instrument. Otherwise, the
reagent may flow into the vacuum line, possibly damaging the instrument.
• After connecting the tube, do not pull it by force for reagent replacement.
Connect STROMATOLYSER-WH
(1) Gently remove the dust-protection bag containing the Float Switch No. 23 Assy that is
connected to the main unit.
(2) Install the float switch to STROMATOLYSER-WH. Then, set it on to the table.
STROMATOLYSER-WH
Information
• Cut the tube to an appropriate length, and connect it.
• The maximum waste line length is 6 m. Since waste is removed from the system by
pressurized air, the waste tank may be located at the same height as, or lower than, the drain
outlet nipple. Otherwise the waste may flow back into the system, which will result in a
malfunction.
Revised July 2017
(3) Arrange and tie the diluent and waste line tubings as shown in the figure using the clamp
provided LWS-85-2.5W.
Tube polyurethane 6 mm ID × 9 mm OD
Clamp LWS-85-2.5W
Waste
container
Pass the tubing through here.
Caution!
When bundling the tubings using the clamp, its sharp edges can cause injury. Use caution.
(4) Pass the printer paper through along the paper guides.
Paper
guide
Information
• Be sure to set the printer paper straight in the right
direction. If the printer paper is crooked, the paper may jam.
• Make sure the printer cover is securely closed.
If the cover is not securely closed, a printing error or
incorrect output may result.
Printer head
Caution, Hot!
The printer head becomes hot. Use caution.
Revised July 2017
Caution!
Static electricity may damage the printer head. Do not
touch with hands.
(6) Cut off any printer paper extending from the upper part of the
printer.
Caution!
When connecting peripheral devices, this instrument
must be switched off.
Graphic printer
Scans the bar code on the sample tube and automatically inputs
the sample ID number.
5.8 Connection of a host computer, printer and handheld bar code reader
Connect to each instrument with connecting cables.
Information
No connection cable for peripheral devices is provided with this instrument.
Note:
When using a host computer or printer, see “Host Output” or “Printer” in “11.2 Possible settings” for
settings relevant to data output.
Revised January 2017
Refer to “14.4 Connecting the bar code reader” and the bar code reader manual for detailed information
on the connection of a bar code reader.
Power cord
Warning!
Be sure to ground the instrument. Improper grounding may cause electrical shock.
Note:
In this chapter, only the settings relevant to the instrument
installation are described. For details on all possible
settings, see “11. Instrument Setup”.
Note:
When time changes to summer or winter time, respectively,
the clock must be corrected manually.
Note:
If a password has been set, the password input screen will
appear. Enter the password. No password is set when the
instrument is shipped; the password input screen will not
appear, until a password is set.
Revised January 2017
(4) Press the Format display column to select a date display format.
Display format Example of display (for February 3, 2012)
[yyyy/mm/dd] 2012/02/03
[mm/dd/yyyy] 02/03/2012
[dd/mm/yyyy] 03/02/2012
The underlined format is the initial setting.
(5) Press the Year display column.
The date input dialog will appear.
(For details about the numerical keys dialog, see “Numerical
keys dialog” in “6.1 Screen display”.)
(6) Enter the year, and press the [Ent.] button.
If an incorrect value was entered, press the [C] button and enter
the correct value again.
(7) Enter the month and day in the same way as when entering the
year.
Information
If an incorrect date was entered (e.g. 4/31 or 2/29 in a
year which is not a leap year), a beep sounds.
Reenter the correct date.
(8) Press the [] button to bring up the second Date/Time setting
screen.
(9) Enter the hour and minute in the same way as when entering the
year.
(10) Press the [Save] button to update the settings.
The setting update confirmation dialog will appear.
Press the [OK] button to update the changed settings.
Press the [Cancel] button to close the dialog, and setting can
be continued.
* Press the [Top] button on the setting screen. The setting stop
confirmation dialog will appear.
Press the [OK] button to return to the Main screen without
Revised January 2017
The LCD contrast can be adjusted with the contrast adjuster located
underside of the LCD panel. It can be reached by opening the front
cover. Slide the adjuster to the right to darken the LCD, and to the
left to brighten it.
Note:
If no operation is performed on the LCD screen for a certain
period of time, the LCD backlight illuminance will decrease
automatically to conserve electric power (backlight dimmer
Contrast adjuster timer function). Touch any portion on the LCD screen to
return to a normally illuminated LCD screen.
Underside of LCD
Revised January 2017
6. Operation
After turning the power ON, the Sysmex logo appears, and the
startup operation is performed. Then the Main screen will appear.
Analysis operation is performed on the Main screen. When the
[Menu] button on the Main screen is pressed, the Menu screen will
appear.
System area
(1) (2) (3) (4) (5) (6) (7) The following information is displayed in the system area on the
upper part of the LCD screen.
(1) button: Prints or deletes the displayed data. This button
also displays a menu screen related to the
SNCS function.
(2) button: Used only for the SNCS function to save the
displayed screen image in bmp format.
For details, see “Screen saving method (Print
screen)” in “6.7 SNCS functions”.
(3) Instrument status indicator
Displays the status of the instrument. The status display shows
5 types of conditions for the instrument: [Ready], [Aspirating],
[Running], [Not Ready] and [PU Sleep].
Revised January 2017
(7) / / button:
The [Menu] button is indicated when the
Main screen is displayed, and it changes into
the [Top] button or [Back] button when any
other screen than the Main screen is
displayed.
This screen appears when an error has occurred and the button
has been pressed.
Follow the instructions on this screen to easily perform a recovery
process.
Dialog screen
Confirmation dialog
Display column
Sample ID
The Main screen sample ID, setting values, and other items which
1 can be changed by the operator appear as white boxes with shadows.
These boxes are referred to as “display columns” in the Instructions
for Use.
Press on a display column to input information.
Selections
For settings which require the selection of one setting from multiple
Type 1 Type 1
options, the options are displayed when the display column is
Type 2 pressed. Press the selection to input that value. If all of the options
cannot be displayed on the screen, the [more] button is displayed in
Type 3
the options area. Press the [more] button to change the displayed
Type 4 options.
more
Revised January 2017
Note:
While the alpha or numerical keys are displayed on the screen, other buttons cannot be operated.
Auto Rinse
Main QC
Drain TD Chamber
Clean W. Chamber
Shutdown
Status Display
Maint.
Manual Calib.
Settings System
Date/Time
QC Chart
Patient Limits
PU Sleep
Quality Control
Product ID
Host Output
Printer
Network
Password Setting
Print Settings
Revised January 2017
Information
When an alarm is sounded, the alarm sound can be
stopped if the [OK] button of the error dialog displayed
on the LCD screen is pressed. Press the button
to display the help menu. All other buttons are not
functional during an alarm.
This instrument stops the pneumatic unit when the [PU Sleep] button
on the Menu screen is pressed.
Pressing the start switch, the instrument will return to “Ready” status.
Screen
image
Data transmission
(QC result, operation log, etc.)
Revised January 2017
You need to sign up the SNCS service contract to use the SNCS
service. For details about the SNCS service contract, contact your
local Sysmex service representative.
Online QC
Maintenance report
(1) Start up report
When the start up of the instrument is complete, the information
that is automatically transmitted to the SNCS server includes:
Analysis data for background check during start up
(2) Shutdown report
When the shutdown is performed or shutdown has not been
performed for 24 hours after the power is turned on, the
information that is automatically transmitted to the SNCS
server includes:
Program version
Cycle counts
Reagent replacement log and calibration log
(3) Maintenance log
When maintenance is carried out, the maintenance log is
automatically transmitted to the SNCS server.
Error report
File transmission
Quality control data, shutdown report, error report and saved screens
using the [PS] button (up to 5 screens) can also be transmitted to the
SNCS server manually.
For details about the screen saving method, see “Screen saving
method (Print screen)” in “6.7 SNCS functions”.
(1) Press the [Out/Del] button on the screen where it is displayed.
The output/delete menu dialog appears.
(2) Press the [File Send] button.
When transmitting a QC chart:
QC data at the cursor position is transmitted to the SNCS
server.
When transmitting any data other than QC chart:
The day’s shutdown report, error report and screens saved
using the [PS] button are transmitted to the SNCS server.
Press and hold the [PS] button (for approximately 1 second) to save
the screen in bmp format (up to 5 screens).
Note:
When there are already 5 screens saved, pressing and
holding the [PS] button (for approximately 1 second) in a
dialog which appears when the [Out/Del] button is pressed
deletes the screen that was first saved.
Press the [File Send] button to transmit the saved screens to the
SNCS server. This is convenient when explaining the displayed
content to your Sysmex service representative.
You cannot use this function when the [PS] button is not displayed
on the screen.
Revised January 2017
Emergency call
Note:
The SNCS function buttons ([PS] button, [File Send] button and [EMG.Call] button) are valid when the
SNCS service setting is made. The setting must be made by a Sysmex service representative only.
7. Sample Analysis
7.1 Introduction
This instrument works in 2 analysis modes: whole blood mode and
pre-diluted mode.
This chapter explains the entire operating procedure from startup to
shutdown of the instrument, as well as the operating procedure in
each analysis mode.
Power cable
Ensure that the power cable is properly connected.
The power cable must be plugged into an outlet.
If it is necessary to replace the power cable, contact your
Sysmex service representative.
(1) Open the front cover of the instrument, and check that the paper
supply is adequate for the number of samples expected for the
day.
For the replacement procedure, see “12.18 Replace internal
printer paper (Printing Paper No. 3)”.
Information
When the tip of printer paper extends from the upper
part of the internal printer, cut off the paper and then
open the front cover.
Information
Use only printer paper recommended by Sysmex.
Inspection of reagents
Check to see that the reagents needed for the number of the samples
to be processed for the day are available. If the number available is
such as might become short during the day, make ready the reagents
for use in replenishment. When reagents run out during analysis, the
instrument will automatically come to a stop. Replenish the reagent
that gave an error. Until replenishment is completed, analysis cannot
be resumed. The number of samples that can be analyzed with one
pack of reagent is listed below:
Revised July 2017
Replenishing reagent
Make ready a new reagent and make sure that it has not passed
its expiration date. (For detail, refer to “12.16 Replace
reagent”.)
Caution!
• Use a reagent that has been left at room
temperature (15 - 30°C) for more than 24 hours.
• If CELLPACK that has just arrived is used, “Blank
Error” may occur.
• After replenishing a reagent, make sure that its
background count is low before starting sample
analysis.
• As to a reagent that may have frozen, handle it in
accordance with the precautions stated on the
Package Insert. Otherwise, there is a possibility
that proper analysis cannot be performed.
• When replacing the reagent container, take care
not to have dust adhere to the cubitainer spout kit.
• After unpacking, take care to prevent entry of dust,
dirt, bacteria, etc. which could impair proper
analysis.
Shelf life after first opening
CELLPACK 20 L 60 days
STROMATOLYSER-WH 500 mL 90 days
Inspection of waste
If waste is collected in the trap chamber on the left side of the unit
and the waste tank (when provided), discard the waste.
7.5 Switching ON
After completion of all checks, the main power switch can be turned
ON.
Turn the main power switch ON.
The LCD screen will be illuminated. The program version will
be briefly displayed.
After the self-check, auto rinse, and background check are
completed, the Main screen will appear.
Self-check
After the main power switch is turned ON, the instrument performs a
self-check. This process takes approximately 2 minutes.
In order to ensure optimal instrument conditions for use at all times,
certain parts require periodic maintenance. This instrument includes
counters which record the number of times that each of these parts
are used. When the main power switch is turned ON, and if either the
counter value exceeds the specified number (see the table below) or
if a certain period of time has passed since the last maintenance, a
message will appear prompting the operator to perform periodic
maintenance. Follow the instructions on the screen and perform the
required maintenance.
Note:
If an error is detected during the self-check, an error
message appears on the LCD screen. Turn the instrument
main power switch OFF.
If the error persists, contact your Sysmex service
representative.
Revised January 2017
Background check
Note:
“Blank Error” may occur, if the instrument is not operated
for several days.
Information
Always perform a quality control prior to operation as
described in “9. Quality Control”.
Conditions of collection
Venipuncture specimens should be collected into EDTA
anticoagulant (EDTA-2K, EDTA-3K or EDTA-2Na) and processed
within 4 hours of collection. If specimens cannot be processed within
4 hours, they should be refrigerated at 2 - 8ºC. Before processing
refrigerated specimens should be allowed to warm up to room
temperature (minimum 15 minutes), then mixed, preferably by
rotation, for at least 2 minutes.
Micro-sampling specimens may be diluted directly into the diluent
without utilization of anticoagulant, or may be collected into micro
collection devices with EDTA anticoagulant for dilution at a later
time.
Sample preparation
Caution!
Blood in which clotting or platelet aggregation has
occurred cannot be analyzed.
Information
• Lysing of red blood cells or platelet aggregation may
occur depending on the anticoagulant, and correct
analysis results may not be obtained. For the
anticoagulant, use either of EDTA-2K, EDTA-3K, or
EDTA-2Na.
• Mix the sample promptly after the blood is drawn. If
mixing is insufficient, platelet aggregation may occur.
• When analyzing a refrigerated sample, take it out of
the refrigerator at least 30 minutes prior to analysis,
to bring it back to room temperature. Once restored
to room temperature, mix the blood sufficiently
before performing analysis.
• Depending on the sample, separation of the WBC
into 3 categories may become less accurate with the
passage of time after the blood is drawn.
• The sample should be analyzed within 4 hours after
collection. If it is not possible to analyze the sample
within 4 hours, store it in a refrigerator at 2 to 8°C
until it can be analyzed.
• Use sample tubes that are 80 mm or less in height.
Note:
All performance claims given in this manual were
Revised January 2017
Information
This setting is kept until the mode is changed – which
is done automatically when performing a quality
control or if the instrument is switched off. When the
[WB] button is pressed, the [WB] button turns red,
and when the [PD] button is pressed, the [PD] button
turns yellow. Always check the analysis mode before
performing the analysis.
Entering a sample ID
Information
• When setting a sample ID to “0”, the analysis result
will not be stored as data, and it will neither be
printed automatically with the internal/external
printer, nor can it be transferred to the host computer
automatically. Also, sample ID “0” will not be
incremented automatically.
• A sample ID cannot be entered when the pneumatic
unit operation is stopped.
Revised January 2017
Note:
If no sample ID is entered, it will be incremented by 1 for
each new analysis.
[Examples]:
123 124
999 1000
999999999999999 1
12-3 12-4
12-999 12-000
A999 A000
If the last character of the sample ID is an alphabetic
character, hyphen or space, it will not be counted up
(incremented) automatically.
Information
Even after pressing the [C] button, the bar code can
be read again.
Make sure that the displayed sample ID is correct, and press the
[Ent.] button.
After the manual input is started, a bar code cannot be read. In this
case, press the [Ent.] button once, then press the [Sample ID]
display column again to read the bar code.
Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017
You can register the operator ID of the analysis using the following 2
methods.
Entering from numerical keys dialog
Entering from handheld bar code reader
For details about numerical keys operations, see “Numerical keys
dialog” in “6.1 Screen display”.
Note:
• The operator ID can be set up to 15 characters
(alphanumeric characters, hyphens and space) in length.
• Up to 6 operator IDs can be registered.
If there are already 6 IDs registered in memory and a new
ID is entered, the oldest ID is deleted.
Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017
Before analysis, you can select the desired operator ID of the analysis
from the registered operator IDs.
Note:
Analysis can be performed even when the operator ID is not
selected.
Analyzing samples
Risk of Infection
Wear protective garments and gloves when
performing sample analysis. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.
Information
Vigorously mixing the sample can damage blood cells
and cause bubbles to form in the sample. If this
occurs, correct analysis results may not be obtained.
(3) Remove the cap while taking care not to allow blood scatter.
(4) Set the tube to the sample probe, and in that condition, press the
start switch.
Start switch
Revised January 2017
Caution!
• Do not remove the sample from the sample probe
while [Aspirating] is displayed. If the sample is
removed from the sample probe while [Aspirating] is
displayed, a correct analysis result may not be
obtained.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the sample tube by that
time.
• To remove the sample tube, lower it straight down.
Take care not to bend the sample probe.
Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.
Sample preparation
Information
• Platelet aggregation tends to occur on micro samples
collected from earlobes or fingertips. To prevent
aggregation, the sample should be diluted and
analyzed immediately after collection. If the analysis
is performed more than 30 minutes after the sample
is diluted, correct analysis results may not be
obtained.
• When a sample tube containing a general
anticoagulant is used, lysing of red blood cells or
platelet aggregation may occur depending on the
anticoagulant, and correct analysis results may not
be obtained. For the anticoagulant, use either of
EDTA-2K, EDTA-3K, or EDTA-2Na.
Note:
All performance claims given in this manual were
generated using specimens in EDTA anticoagulant. Results
may be affected by the use of other anticoagulants.
Therefore, each laboratory should develop protocols for
handling specimens collected in their anticoagulants.
Revised January 2017
Risk of Infection
When preparing PD-mode analysis samples, always
wear protective garments and gloves. After
completion of work, wash hands with disinfectant.
If your hands are contaminated by blood, etc.,
infection of bacteria can occur.
Caution!
A 1:26 dilution sample is prone to platelet
agglutination. So, analyze the sample within 30
minutes after blood dispensing and diluting. If diluent
is dispensed in advance, evaporation and dirt mixing
will result in errors in analysis values. Therefore
prepare one sample at a time.
When preparing a 1:26 dilution sample, use the tools listed below:
Diluent (CELLPACK)
Micro tube (MT-40, etc.)
Capillary tube
Probe: 500 L
A container, such as erlenmeyer flask or beaker
A syringe
Revised January 2017
Information
This setting is kept until the mode is changed – which
is done automatically when performing a quality
control or if the instrument is switched off. When the
[WB] button is pressed, the [WB] button turns red,
and when the [PD] button is pressed, the [PD] button
turns yellow. Always check the analysis mode before
performing the analysis.
Entering a sample ID
The sample ID can be entered by the following 2 methods.
Entering from numerical keys dialog
Entering from handheld bar code reader
The sample ID can be set up to 15 characters (alphanumeric
characters, hyphens and space) in length.
With the setting using ISBT128 bar code, up to 13 characters can be
used. For setting method of ISBT128 bar code, see “System” in
“11.2 Possible settings”.
For entering numerals, see “Numerical keys dialog” in “6.1 Screen
display”.
Information
• When setting a sample ID to “0”, the analysis result
will not be stored as data, and it will neither be
printed automatically with the internal/external
printer, nor can it be transferred to the host computer
automatically. Also, sample ID “0” will not be
incremented automatically.
• A sample ID cannot be entered when the pneumatic
unit operation is stopped.
Revised January 2017
Note:
If no sample ID is entered, it will be incremented by 1 for
each new analysis.
[Examples]:
123 124
999 1000
999999999999999 1
12-3 12-4
12-999 12-000
A999 A000
If the last character of the sample ID is an alphabetic
character, hyphen or space, it will not be counted up
(incremented) automatically.
Information
Even after pressing the [C] button, the bar code can
be read again.
Make sure that the displayed sample ID is correct, and press the
[Ent.] button.
After the manual input is started, a bar code cannot be read. In this
case, press the [Ent.] button once, then press the [Sample ID]
display column again to read the bar code.
Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017
You can register the operator ID of the analysis using the following 2
methods.
Entering from numerical keys dialog
Entering from handheld bar code reader
For details about numerical keys operations, see “Numerical keys
dialog” in “6.1 Screen display”.
Note:
• The operator ID can be set up to 15 characters
(alphanumeric characters, hyphens and space) in length.
• Up to 6 operator IDs can be registered.
If there are already 6 IDs registered in memory and a new
ID is entered, the oldest ID is deleted.
Caution!
• When using a bar code label, affix it properly so it is
flat and smooth without creases or flares.
• A reading error may occur when a bar code reader is
used without a check digit. It is recommended to use
a check digit or to check the sample ID after entry.
For details about check digits, see “ID Bar code
specifications” in “14.4 Connecting the bar code
reader”.
• Do not use any other characters than alpha-
numerics, hyphens and space on the bar code label.
Revised January 2017
Before analysis, you can select the desired operator ID of the analysis
from the registered operator IDs.
Note:
Analysis can be performed even when the operator ID is not
selected.
Analyzing samples
Risk of Infection
Wear protective garments and gloves when
performing sample analysis. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.
Information
Vigorously mixing the sample can damage blood cells
and cause bubbles to form in the sample. If this
occurs, correct analysis results may not be obtained.
(3) Remove the cap while taking care not to allow blood scatter.
Revised January 2017
Start switch (4) Set the micro tube to the sample probe, and in that condition,
press the start switch.
Caution!
• Do not remove the sample from the sample probe
while [Aspirating] is displayed. If the sample is
removed from the sample probe while [Aspirating]
is displayed, a correct analysis result may not be
obtained.
• Single beep sounds (beep, beep, beep, …) continue
while aspirating. When aspiration ends, short beep
sounds twice “beep, beep” and the rinse cup lowers
several seconds after [Running] appears on the
screen. Remove the micro tube by that time.
• To remove the micro tube, lower it straight down.
Take care not to bend the sample probe.
Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.
Note:
• Analysis results of the last sample can be re-analyzed by
moving the discriminator positions in the histogram. For
details, see “Manual discrimination” in “8.1 Latest sample
(analysis result screen)”.
• If no buttons on the screen are pressed, the screen will
automatically return to the Main screen when the next
analysis can be performed.
Press the [Result] button on the Main screen to display the
analysis results.
Note:
User settings can also be made for automatic output.
(See “11. Instrument Setup”.)
Revised January 2017
Caution!
If the instrument is used continuously without
performing the Shutdown sequence, protein build-up
on the internal parts may prevent obtaining correct
analysis results, and may damage the instrument.
Information
If the instrument is turned OFF without executing a
Shutdown, water droplets may come out of the rinse
cup or deposits may build-up on the rinse cup.
Note:
• It takes approximately 5 minutes to complete the Shutdown
sequence.
• If you repeatedly restart the instrument after Shutdown, the
shutdown confirmation dialog screen appears each time.
Start switch (2) Set the CELLCLEAN to the sample probe, and in that
condition, press the start switch.
While [Aspirating] is being displayed on the screen, keep
holding CELLCLEAN in the same status, as long as the “beep”
is present.
Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water. Otherwise, it can damage the
skin or clothes.
Caution!
• When the sample is being aspirated, [Aspirating]
appears on the screen. Do not remove the
CELLCLEAN from the sample probe while
[Aspirating] is displayed. Otherwise, there is a
possibility that proper aspiration cannot be
performed.
• To remove CELLCLEAN, lower it straight down.
Take care not to bend the sample probe.
(3) Check that the shutdown sequence was completed and that the
shutdown completion screen is displayed.
Turn OFF the main power switch on the right side of the
instrument.
When the [Restart] button is pressed, the Main screen will
appear.
Revised January 2017
Information
Data stored in memory includes QC analysis results.
Analysis mode
Analysis mode
WBC histogram
Analysis data
Analysis mode
RBC histogram
Analysis data
PLT histogram
Analysis mode
WBC histogram
Analysis data
* For details about WBC research parameters, see “2. WBC research parameters” in “14.6 Functional
description”.
Revised January 2017
[Out/Del]: Prints the analysis results. For details, see “Output of analysis result
(latest sample)” in “8.1 Latest sample (analysis result screen)”.
[M. Discri.]: Relocates particle distribution discrimination in the histogram and re-
calculates the data. For details, see “Manual discrimination” in
“8.1 Latest sample (analysis result screen)”.
[ID Edit]: Edits the sample ID number. For details, see “Editing the sample ID” in
“8.1 Latest sample (analysis result screen)”.
[] []: Switches the analysis result screens (first - fourth) in display order. For
details, see “8.1 Latest sample (analysis result screen)”.
Sample ID: Displays the sample ID number.
Analysis mode: Displays the analysis mode for the sample.
Displays [WB] for the whole blood mode, and [PD] for the pre-diluted
mode.
Date and time of analysis: Displays the date and time when the analysis result was obtained.
Operator ID: Displays the operator ID of the analysis.
Analysis data: Displays the analysis data of each parameter.
Meanings of signs displayed on the left of the analysis data are as
follows:
Sign Explanation
[!] Value is out of the linearity limit.
[+] Result exceeds the upper patient limit.
[-] Result exceeds the lower patient limit.
[] Result is unreliable.
Note:
The values for [+] and [-] patient limits can be set by the customer.
Check the “Patient Limits” in “11. Instrument Setup”.
If an analysis error has occurred and a value is not available, one of the
following is displayed:
Display Explanation
[+++.+] Value exceeds display range.
[.] Value could not be calculated because of analysis error.
At this time, the analysis error flag, [ERROR] (inverse in
coloration display) appears.
[---.-] Value could not be calculated due to data error, or
volume distribution analysis parameter is not displayed
when the analysis was performed in pre-diluted mode.
Revised January 2017
Manual discrimination
Information
• Manual discrimination can be performed only on the
latest sample.
• Manual discrimination cannot be performed on the
data with sample number 0.
(1) Press the [M. Discri.] button on the analysis result screen.
The manual discrimination parameter selection dialog will
appear.
(3) Press the [] button to select the discriminator you want to
change from a list at the bottom left of the screen.
The selected discriminator is highlighted.
(4) Press the [] or [] button to move the discriminator position
on the histogram.
The discriminator position relocated is displayed in the list at
the bottom left of the screen.
The range within which each discriminator position can move is
shown below.
Manual discrimination screen
(WBC)
Manual discrimination screen (WBC)
Discri. to move Lower limit Upper limit
LD 6fL (0ch) T1
T1 LD T2
T2 T1 UD
UD T2 300fL (49ch)
Note:
Pressing the [Top] button on the analysis result screen also
displays the manual discrimination quit confirmation
dialog. In this case, pressing the [OK] button in the dialog
returns to the Main screen without changing the settings.
(2) Select the output destination button from the internal printer
(IP), graphic printer (GP), list printer (LP) or host computer
(HC).
[Current]: Prints/outputs the analysis result.
[Cancel]: Closes the output/delete menu dialog.
Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Host Output] and
[Printer] in the Settings menu.
• When outputting to the host computer, it is possible to
output to either the serial port (RS-232C) or LAN
(Ethernet), depending on the user setting.
• User settings can also be made for automatic output.
(See “Host Output” and “Printer” in “11.2 Possible
settings”.)
Information
If the number of samples that can be stored in
memory is exceeded and a new analysis is
performed, the oldest data is deleted (first in, first out).
Data stored in memory includes QC analysis results.
Note:
• In the stored data screen, the data can be displayed in the
order of analysis date.
• When the stored data screen is displayed, the cursor appears
on the sample most recently viewed.
• If the [Str. Data] button is pressed when no stored data are
present, a dialog to the effect that no data are available is
displayed instead of the list screen.
Revised January 2017
To return to the Main screen, press the [Top] button on the stored
data screen.
Sample ID and analysis mode on the Main screen will return to the
settings before executing the stored data processing program.
Press the [Str. Data] button on the Menu screen to display the stored data screen.
The stored data screen is composed of list screens (first to fourth) and detail screens (first to fourth). Screens
can be switched by pressing the [] button and are displayed in the order as shown below.
First list screen Second list screen Third list screen Fourth list screen
Fourth detail screen Third detail screen Second detail screen First detail screen
Displays the sample ID, sample ID attribute, analysis mode, date and time of analysis and instrument error
flag in the stored data.
Memory No.
Instrument error flag
Not-output mark
Sample ID
Cursor sample
Displays the sample ID, analysis mode and operator ID in the stored data.
Analysis mode
Sample ID Operator ID
Cursor sample
Analysis mode
Cursor sample
Analysis mode
Cursor sample
[Out/Del]: Prints or deletes the stored analysis data. For details, see “Output of
stored data” and “Deleting stored data” in “8.2 Stored data”.
[Search]: Searches for the stored analysis data. For details, see “Searching
stored data” in “8.2 Stored data”.
[Graph]: Displays the first detail screen of the selected sample data.
[]: Moves to the previous analysis result.
However, when the oldest analysis result is selected, this button
operation becomes invalid.
[]: Moves to the next analysis result.
However, when the latest analysis result is selected, this button
operation becomes invalid.
[]: Switches the screen in such an order as first to fourth (list) and first to
fourth (detail). For details, see “Stored data screen” in “8.2 Stored
data”.
Sample ID: Displays the sample ID number.
Histogram error flag or numeric value abnormal flag:
When a flag is added to the analysis result, the column next to the
sample ID is displayed in red or yellow.
The following flags are shown depending on the color.
Color Flag
Red Out of the linearity limit flag [!]
Numeric value abnormal flag (low reliability data flag [], out
of the patient limit flags [+] and [-])
Yellow Histogram error flag ([WL], [WU], etc.)
* For details about histogram error flags, see “8.3 Histogram
error flags”.
Not-output mark: Displays whether or not the analysis data has been printed from the
internal/graphic printer or output to the host computer.
[I] : The data has not been printed from the internal printer. The mark
disappears when printed.
[G] : The data has not been printed from the graphic printer. The mark
disappears when printed.
[H] : The data has not been output to the host computer. The mark
disappears when output.
Detail screen
Analysis results of the selected sample are displayed on the detail screen.
The detail screen is composed of 4 screens (first to fourth), each of which displays analysis results of the
following parameters:
First detail screen WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT
Second detail screen WBC, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#
Third detail screen RBC, MCV, RDW-SD, RDW-CV, PLT, PDW, MPV, P-LCR, PCT
Fourth detail screen WBC research parameters (ResearchW, ResearchS, ResearchM, ResearchL)
Analysis mode
[Out/Del]: Prints or deletes the stored analysis data. For details, see “Output of
stored data” and “Deleting stored data” in “8.2 Stored data”.
[Search]: Searches for the stored analysis data. For details, see “Searching stored
data” in “8.2 Stored data”.
[List]: Displays the first list screen. The cursor is located at the sample data that
is currently displayed.
Revised January 2017
On the stored data screen, data can be searched for using the sample
ID and the date of analysis as the search key.
(1) Press the [Search] button on the stored data screen.
The search dialog will appear.
Note:
• When the numeric keypad is displayed in the search dialog,
boxes in which you can input are reverse-displayed.
• A bar code can also be input while displaying the numeric
Revised January 2017
keypad.
• The search dialog is displayed with the date on that day in
the Date [Year], [Month] and [Day] display columns.
(3) Enter a sample ID or date using the keypad and press the
[Search] button.
Note:
Searching cannot be carried out when only space is entered.
Press the [Cancel] button to cancel the search and close the
dialog.
All analysis results are displayed on the search result screen and
the cursor moves to the latest analysis data among those that
fulfill the search condition.
Press the [Graph], [], [] or [] buttons to select data and
switch the screens. (For details, see “Stored data screen” in
“8.2 Stored data”.)
To conduct an additional search, press the [Search] button.
Press the [Back] button to close the search result screen and
return to the stored data screen.
Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Host Output] and
[Printer] options in the Settings menu.
• When outputting to the host computer, it is possible to
output to either the serial port (RS-232C) or LAN
(Ethernet), depending on the user setting.
• User settings can also be made for automatic output.
Revised January 2017
The analysis data displayed on the stored data screen can be printed
by the internal/external printer, or output to the host computer.
(1) Select the data you want to output on the list screen of the stored
data screen or display the data you want to output on the detail
screen, then press the [Out/Del] button.
The output/delete menu dialog is displayed.
(2) Select the output destination button from the internal printer
(IP), graphic printer (GP), list printer (LP) or host computer
(HC).
[Current]: Prints/outputs the analysis result.
[Cancel]: Closes the output/delete menu dialog.
Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Host Output] and
[Printer] options in the Settings menu.
• When outputting to the host computer, it is possible to
output to either the serial port (RS-232C) or LAN
(Ethernet), depending on the user setting.
• User settings can also be made for automatic output.
(See “Host Output” and “Printer” in “11.2 Possible
settings”.)
Revised January 2017
You can delete analysis data displayed on the stored data screen.
(1) Select the data you want to delete on the list screen of the stored
data screen or display the data you want to delete on the detail
screen, then press the [Out/Del] button.
The output/delete menu dialog is displayed.
9. Quality Control
The reliability of this instrument and reagents is monitored by quality
control. By use of control blood or control materials the stability of
the measured value is monitored over a certain period of time, and
problems can be detected early or prevented.
A quality control should be performed:
Before analyzing samples
After replacement of the reagent
After maintenance
If there is any doubt about the accuracy of the analysis values
As required by regulation(s)
Information
• Do not use any other control material than
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H. This control blood is
specially developed for the analyzer’s measuring
technology.
• When opening a new lot, the previously entered
assay values and lot numbers must be erased.
Product name
Intended purpose
Revised January 2017
Composition
Note:
If other control materials are used the product performance
of Sysmex instruments cannot be guaranteed.
Revised January 2017
Procedure
Note:
Always check with current control materials insert
instructions.
Manual procedures
Reference method can be applied to EIGHTCHECK-3WP-N,
EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H. Refer to a
manual for clinical laboratory procedures.
Methodology
Disposal
References
X control
Perform daily.
Information
A total of 6 quality control files can be stored. Each file
can contain data of up to 22 parameters by 60 points.
Note:
If a password has been set, the password input screen will
appear. Enter the password.
Information
When outputting to the host computer, the instrument
outputs to the serial port (RS-232C) or LAN
(Ethernet), depending on the connection settings for
host computer. (See “11. Instrument Setup”.)
+ LIMIT
TARGET
- LIMIT
Note:
QC file settings can be made using file display columns 1 - 6.
If settings are made in a display column that has a registered
QC file, the existing file will be overwritten.
Note:
Pressing the [Setup] button on the QC chart screen also
displays the first QC file setting screen. For further
information regarding the displays, see “9.7 Quality control
chart screen”.
Note:
Revised January 2017
Note:
The QC file setting screens are consisted of 6 screens.
Information
There are 22 control parameters, and since not all of
these can be displayed on one screen, switch the LCD
screen by using the [] or [] button.
Note:
When 2 or more plots are present in the base QC data, the
TARGET value and LIMIT value can be calculated
automatically. For details, see “Automatic settings of the
TARGET value and LIMIT value” in “9.5 Settings for
control blood information (QC files)”.
Revised January 2017
Note:
• To clear all of the set information, press the [Clear] button
on the first QC file setting screen.
The deletion confirmation of quality control setting
message will be displayed.
Press the [OK] button to return the control data to
default and to close the dialog.
Press the [Cancel] button to cancel control data
deletion and return to the previous screen.
• Pressing the [IP] button on the first QC file setting screen
prints out the current file’s lot ID, expiration date,
TARGET value and LIMIT width of each parameter in the
quality control printing format.
Note:
QC file settings can be made using file display columns 1 -
6.
If settings are made in a display column that has a
registered QC file, the existing file will be overwritten.
Note:
Pressing the [Setup] button on the QC chart screen also
displays the first QC file setting screen. For further
information regarding the displays, see “9.7 Quality control
chart screen”.
Note:
The QC file setting screens are consisted of 6 screens.
Revised January 2017
(7) Read each of the bar code in the Assay Sheet in the same way as
(4).
Note:
• In each parameter, bar code has the information of
TARGET value and LIMIT value.
Only the item that appears in the display can be input.
When all parameters are input in the screen, switch the
screen by using the [] button to continue input.
• When 2 or more plots are present in the base QC data, the
TARGET value and LIMIT value can be calculated
automatically. For details, see “Automatic settings of the
TARGET value and LIMIT value” in “9.5 Settings for
control blood information (QC files)”.
Note:
• To clear all of the set information, press the [Clear] button
on the first QC file setting screen.
The deletion confirmation of quality control setting
message will be displayed.
Press the [OK] button to return the control data to
default and to close the dialog.
Press the [Cancel] button to cancel control data
deletion and return to the previous screen.
• Pressing the [IP] button on the first QC file setting screen
prints out the current file’s lot ID, expiration date,
TARGET value and LIMIT width of each parameter in the
quality control printing format.
Revised January 2017
Note:
For setting methods of control blood information including
TARGET and LIMIT values, see “Entering from numerical
keys dialog” or “Entering from handheld bar code reader”
in “9.5 Settings for control blood information (QC files)”.
(1) Press the [A.Tgt] button on the QC file setting screens (second
to sixth).
A TARGET value is automatically calculated.
If 2 or more plots present: The automatic target confirmation
dialog will appear. Press the
[Execute] button. The average of all
plots is automatically calculated and
displayed on the button in the
[TARGET] column.
If 1 or no plot presents: A dialog to the effect that no
calculation is possible is displayed.
(2) Press the [A.Lmt] button.
A LIMIT value is automatically calculated.
If 2 or more plots present: The automatic limit selection dialog
will appear. Select a LIMIT width
from [2SD] and [3SD].
2SD or 3SD of all plots is
automatically calculated, and
displayed on the button in the
[LIMIT] column.
If 1 or no plot presents: A dialog to the effect that no
calculation is possible is displayed.
Revised January 2017
Risk of Infection
Wear protective garments and gloves when you
analyze the control blood. After completion of work,
wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can
occur.
Information
Before performing analysis, it is necessary to select a
control method and enter the control blood
information.
(See “9.4 Control method selection” and “9.5 Settings
for control blood information (QC files)”.)
Note:
Pressing the [IP Print] button on the analysis starting
screen prints out the current file’s lot ID, expiration date,
TARGET value and LIMIT width of each parameter in the
quality control printing format.
Revised January 2017
X control
(1) Be sure the status display indicates [Ready] for quality control
analysis.
Note:
QC analysis is always performed in the whole blood mode.
When the analysis mode is set in the pre-diluted mode, the
mode changeover sequence is activated to switch to the
whole blood mode.
(2) Mix control blood by rotating and inverting 10 times each for 2
minutes.
Caution!
The control blood (EIGHTCHECK-3WP) remains
usable for the specified period of days in the package
insert. If it is used after this point, abnormal count
values may result.
(3) Remove the cap while taking care not to allow blood to scatter.
(4) Set the control blood container to the sample probe and press
Start switch
the start switch in that status.
Revised January 2017
Caution!
• When analysis starts, the status reads [Aspirating].
When sample aspiration is completed, the status
display [Aspirating] changes to [Running]. When
[Running] is displayed, the control blood container
can be removed safely.
Do not remove the control blood container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the control blood container
by that time.
• To remove the container, lower it straight down. Take
care not to bend the sample probe.
Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.
Information
The print format is used for quality control analysis
only and cannot be changed.
Press the [OK] button to accept data from the first analysis and
perform the second analysis. If the analysis results are not to be
accepted, you can perform a new analysis by pressing the [NG]
button. In either case, remove the control blood, close the cap,
and mix well.
Then, remove the cap again, set the control blood to the sample
probe, and press the start switch of the instrument.
Revised January 2017
When the second analysis is completed, the analysis results from this
analysis will be displayed in the [X2] column on the analysis result
screen. The mean values of the analysis results from the first and the
second analyses will be displayed in the [X] column. Use the [] or
[] button to scroll the screen pages.
Press the [IP] button to print the second analysis results and the
mean of the first and the second analysis results.
* When the [Top] button is pressed, the “Quit QC Analysis?”
message will be displayed.
Press the [OK] button to discard the analysis results and return
to the Main screen.
Press the [Cancel] button to return to the previous screen.
Press the [OK] button to accept the results of the two analyses,
and output the mean of the two analyses to the internal printer
or host computer, depending on the quality control data output
settings. If the results of the second analysis are not to be
adopted, press the [NG] button to perform a new second
analysis. When performing re-analysis, remove the control
blood, close the cap, and mix well. Then, remove the cap again,
set the control blood to the sample probe, and press the start
switch of the instrument.
Note:
The analysis results are saved to the stored data.
For parameters with a mean of the two analyses that is beyond the
control limit and if the value is above the higher limit, + is
displayed in the [Judgment] column, and if the values are below the
lower limit, – is displayed. Then an alarm sounds and the QC error
message is displayed.
Press the button and the action message will appear.
Information
For details about actions to resolve the QC (X) error,
see “QC(X-bar) Error” in “13. Troubleshooting”.
L-J control
(1) Be sure the status display indicates [Ready] for quality control
analysis.
Note:
QC analysis is always performed in the whole blood mode.
When the analysis mode is set in the pre-diluted mode, the
mode changeover sequence is activated to switch to the
whole blood mode.
(2) Mix control blood by rotating and inverting 10 times each for 2
minutes.
Caution!
The control blood (EIGHTCHECK-3WP) remains
usable for the specified period of days in the package
insert. If it is used after this point, abnormal count
values may result.
(3) Remove the cap while taking care not to allow blood to scatter.
(4) Set the control blood container to the sample probe and press
Start switch
the start switch in that status.
Revised January 2017
Caution!
• When analysis starts, the status reads [Aspirating].
When sample aspiration is completed, the status
display [Aspirating] changes to [Running]. When
[Running] is displayed, the control blood container
can be removed safely.
Do not remove the control blood container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the control blood container
by that time.
• To remove the container, lower it straight down. Take
care not to bend the sample probe.
Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.
The analysis results are displayed in the [Data] column and these
results are compared with the control limit and displayed in the
[Judgment] column on the analysis result screen.
Use the [] or [] button to scroll the screen pages.
To print results on the internal printer, press the [IP] button.
Information
The print format is used for quality control analysis
only and cannot be changed.
Revised January 2017
Note:
The analysis results are saved to the stored data.
Information
For details about actions to resolve the QC (L-J) error,
see “QC(L-J) Error” in “13. Troubleshooting”.
Revised January 2017
Note:
When the quality control chart screen is displayed, the
screen for the sample most recently viewed or updated
appears.
The quality control chart screen is consisted of 11 screens, each of which displays data of the following
parameters:
With the default settings, the first quality control chart screen is displayed first.
First quality control chart screen WBC, RBC Seventh quality control chart screen MXD#, NEUT#
Second quality control chart screen HGB, HCT Eighth quality control chart screen W-SMV, W-LMV
Third quality control chart screen MCV, MCH Ninth quality control chart screen RDW-SD, RDW-CV
Fourth quality control chart screen MCHC, PLT Tenth quality control chart screen PDW, MPV
Fifth quality control chart screen LYM%, MXD% Eleventh quality control chart screen P-LCR, PCT
Lot ID
File Expiration date
Item
Chart
Operator ID
Revised January 2017
[Out/Del]: Prints or deletes the quality control data. For details, see “Printing control
chart”, “External output” and “Deleting data” in “9.7 Quality control
chart screen”.
[]: Changes the screens in the following order; “First chart screen”
“Eleventh chart screen” ... “Second chart screen” “First chart
screen”.
[]: Changes the screens in the following order; “First chart screen”
“Second chart screen” ... “Eleventh chart screen” “First chart
screen”.
[]: Moves the control chart cursor (vertical line) to the previous plot and
updates the data and date/time accordingly. When the cursor is located at
the left end of the chart, the button is not operative.
[]: Moves the control chart cursor (vertical line) to the next plot and updates
the data and date/time accordingly. When the cursor is located at the right
end of the chart or on the latest plot, the button is not operative.
[QC File]: Displays the quality control file
selection screen.
Press the display column of each
file to display the corresponding
quality control chart screen.
[Setup]: Displays the first quality control file setting screen of the file that is
currently displayed.
Lot ID: Displays the lot ID number.
Expiration date: Display the expiration date.
Date and time of analysis: Displays the analysis date/time for the selected data.
Item: Displays the analysis parameters.
Chart: Displays up to 60 points of quality control data.
If the number of data is less than 60, all data are displayed in order from
the left end.
If the operator calls up another parameter by using the [] or [] button,
the same range of the data are displayed for that parameter.
Operator ID: Displays the operator ID of the analysis.
Revised January 2017
(2) Select the output destination button from the internal printer
(IP), graphic printer (GP) or list printer (LP).
[Current]: Prints out the data at the cursor position in the
control quality printing format.
[Chart]: Prints out control charts of all parameters.
[All]: Prints out all plot data of the file being displayed
(up to 60 plots).
[Cancel]: Closes the output/delete menu dialog.
Note:
• The output/delete menu dialog buttons are valid only for
output destination buttons set in [Printer] in the Settings
menu.
• User settings can also be made for automatic output.
(See “Printer” in “11.2 Possible settings”.)
• While this dialog appears on the LCD, other buttons outside
the dialog are not operative.
External output
(1) Press the [Out/Del] button in the quality control chart screen.
The output/delete menu dialog will appear.
(2) Press the [Current] button next to “HC”.
The data at the cursor position is output to the host computer in
the quality control output format. It is possible to output to
either the serial port (RS-232C) or LAN (Ethernet), depending
on the user setting.
Note:
• User settings can also be made for automatic output.
(See “Host Output” in “11.2 Possible settings”.)
• When no setting is made to output to the host computer, the
Revised January 2017
Deleting data
(1) Press the [Out/Del] button in the quality control chart screen.
The output/delete menu dialog will appear.
(2) Press the [Current] button next to “Delete”.
A dialog confirming the deletion of the current control data will
appear.
Press the [OK] button to delete the data at the cursor
position in the quality control chart and close the dialog.
Press the [Cancel] button to cancel control data deletion and
return to the previous screen.
10. Calibration
Calibration is performed to compensate for any inaccuracies of the
pneumatic, hydraulic, and electric systems which will affect analysis
results. This is very important in maintaining the system accuracy.
Calibration is carried out by entering calibration values into the
instrument.
Your Sysmex service representative will perform initial calibration
of your unit at installation. After installation, the operator should
make periodical calibration and proper quality control to maintain
the accuracy.
This chapter describes the calibration procedure.
Caution!
Calibration verification needs to be performed in
specified intervals, but when quality control data
varies with time, HGB and HCT should be calibrated.
When abnormal quality control data occur as a result
of instrument problem, reagent degradation, or
deterioration of control blood, however, do not perform
calibration.
Revised January 2017
Automatic Manual
calibration calibration
Perform analysis
Page 10-7
(* in whole blood mode).
Update calibration value.
• Select manual calibration mode.
• Enter calibration value.
Update calibration value. Page 10-8 Page 10-10
Information
For calibration, do not use EIGHTCHECK-3WP.
EIGHTCHECK-3WP was not prepared for calibration
but for the use as control blood.
Note:
If a password has been set, the password input screen will
appear. Enter the password.
(1) Enter the reference values determined into the Target column.
When the button for the Target is pressed, the numerical keys
dialog will be displayed.
After entering a target value, press the [Ent.] button. The
entered value will be defined.
Information
Set “0” for the parameter that is not being calibrated.
Performing analysis
When all target values have been entered, the instrument is ready for
analysis.
Information
Automatic calibration is always performed in the whole
blood mode. When the analysis mode is set in the
pre-diluted mode, the instrument will automatically
switch to the whole blood mode.
Set the sample to the sample position, and press the start switch to
start analysis.
The automatic calibration analyzing screen will appear.
Caution!
• Analyze the samples used for determining the
reference value. The values of the sample to be
analyzed are indicated by the underline cursor.
• When analysis starts, the status reads [Aspirating].
When sample aspiration is completed, the status
display [Aspirating] changes to [Running]. When
[Running] is displayed, the sample can be removed
safely.
Do not remove the sample tube from the sample
probe while [Aspirating] is displayed. Otherwise,
there is a possibility that proper aspiration cannot be
performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the sample tube by that
time.
• To remove the sample tube, lower it straight down.
Take care not to bend the sample probe.
Note:
The sample probe is automatically rinsed, so there is no
need to wipe it clean.
Revised January 2017
Information
During analysis, if the mean calibration value for each
analysis exceeds 105% or is less than 95%, or if the
new calibration value exceeds 120% or is less than
80%, an alarm sounds and the automatic calibration
error confirmation dialog will appear.
Press the [Cancel] button, and analyze again.
The calibration ratio can be calculated using the
following formula.
New calibration
value
Calibration Ratio = × 100
Current calibration
value
Information
Use normal and fresh blood of 5 or more samples.
14.0
98.7 × = 97.30 97.3
14.2
Therefore, the new calibration value of HGB needs to be set at
97.3%.
Revised January 2017
Note:
If a password has been set, the password input screen will
appear. Enter the password.
(4) Press the calibration value display column for the calibrated
parameter.
The numerical keys dialog will be displayed.
Revised January 2017
Note:
If nothing is input (space), the calibration value cannot be
defined.
Information
An alarm sounds and the manual calibration error
confirmation dialog is displayed, if the mean
calibration value for each analysis exceeds 105% or is
less than 95%, or if the new calibration value exceeds
120% or is less than 80%.
The calibration ratio can be calculated using the
following formula.
New calibration
value
Calibration Ratio = × 100
Current calibration
value
Note:
If a password has been set, the password input screen will
appear. Enter the password.
Note:
Upon initial operation, some settings need to be updated.
Example: Current date and time
11.1 Introduction
(1) Press the [Menu] button at the Ready status.
The Menu screen will appear.
Note:
If a password has been set, the password input screen will
appear. Enter the password.
Note:
The underlined items are the initial settings made before
shipment from the factory.
System
Make the basic settings for the instrument.
Parameter Setting
[Units] [Type 1]/[Type 2]/[Type 3]/[Type 4]/[Type 5]/
[Type 6]
[Type 1]: Japan
[Type 2]: General Export
[Type 3]: Canada SI
[Type 4]: Dutch SI
[Type 5]: Standard SI
[Type 6]: Hong Kong SI
Setting changes made for this parameter become
valid the next time the main power switch is
turned ON. For details, see “14. Technical
Information”.
[Language] [Japanese]/[English]/[French]/[German]/
[Spanish]/[Italian]/[Chinese]/[Russian]/
[Portuguese]/[Indonesian]/[Korean]/
[PT-BR]*1
Setting changes made for this parameter become
valid the next time the main power switch is
turned ON.
*1: Brazilian Portuguese
[Par.Name] [W-SCR]/[LYM%]
Setting changes made for this parameter become
valid the next time the main power switch is
turned ON.
[Volume] [1]/[2]/[3]
[1]: Quiet
[2]: Medium
[3]: Loud
[Alarm] [Type 1]/[Type 2]/[Type 3]/[Type 4]/[Type 5]/
[Type 6]
[Type 1]: High continuous beep
[Type 2]: Repeated high beeps
Revised January 2017
Parameter Setting
[ISBT128] [Enable]/[Disable]
When [Enable] is selected, the ISBT128 bar
code will be loaded as a sample ID number with
up to 13 characters.
[ID Inc.] [Enable]/[Disable]
When [Enable] is selected, the sample ID
number is automatically incremented.
Information
It is not possible to convert the stored data between
Dutch SI units and other units for the following 3
parameters: HGB, MCH and MCHC.
Do not use the stored sample data which was stored
before the setting change. In addition, renew settings
for patient limits, and for quality control TARGET and
LIMIT values.
Date/Time
Note:
• When time changes to summer or winter time, respectively,
the clock must be manually corrected accordingly.
• Numeric input exceeding the upper limit is replaced with
the upper limit value in each parameter.
Parameter Setting
[Format] [yyyy/mm/dd]/[mm/dd/yyyy]/[dd/mm/yyyy]
[Year] Numeric input: 2000 - 2037
[Month] Numeric input: 1 - 12
[Day] Numeric input: 1 - 28/29/30/31
Determine the available numeric input range by
the Year and Month settings.
[Hour] Numeric input: 0 - 23
[Minute] Numeric input: 0 - 59
Revised January 2017
Patient Limits
The upper and lower mark limits for the patient results can be entered
here. If the analysis result exceeds the Upper Limit (UL), a [+] flag is
added next to that parameter. If the result is below the Lower Limit
(LL), a [-] flag is added. (See the table below for the initial settings.)
Note:
If LL or UL that satify the following conditions was entered
in the Patient Limit setting screen, a beep sounds and the
entering is canceled.
• LL is higher than UL.
• UL is lower than LL.
Revised January 2017
Quality Control
Here the QC method and the data output method can be selected.
Parameter Selection
[QC Method] [X]/[L-J]
[Data Out.] [Disable]/[IP]/[GP]/[HC]/[IP+HC]/
[GP+HC]
Product ID
Host Output
The method of data output to the host computer can be set here.
Parameter Setting
[Connect] [Disable]/[Serial]/[LAN]
[Auto Out.] [Enable]/[Disable]
[Format] [XP]/[pocH]/[KX-21N]/[ASTM]/
[K-1000]/[K-DPS]
[T. Rate] [1200 bps]/[2400 bps]/[4800 bps]/
[9600 bps]/[19200 bps]
[Data Len.] [7 bits]/[8 bits]
[Stop bit] [1 bit]/[2 bits]
[Parity] [Even]/[Odd]/[Disable]
[Protocol] [Class A]/[Class B]
[T. Interv.] [0 s]/[2 s]/[3 s]/[5 s]/[7 s]/[10 s]/[15 s]
[RTS/CTS] [Enable]/[Disable]
[ID Pad.] [0 Pad.]/[SpacePad.]
[RDW] [RDW-SD]/[RDW-CV]
[ASTM Rev.] [1381-95]/[1381-02]
Note:
Revised January 2017
Printer
The method of printing out analysis results can be set here. The print
header can be set as desired, using information such as the laboratory
name or instrument name. See “14.3 Print formats”.
For entering numerals, see “Numerical keys dialog” in “6.1 Screen
display”.
Parameter Setting
[Header]*1 Alphanumeric input: Up to 16 digits of
First to third lines alphanumeric
characters for
each line
[Int.Print]*2
[IP Auto Pri.] [All Data]/[Error Data]/[Disable]
[Format] [Type 1]/[Type 2]/[Type 3]
[Type 1]: Prints 20 analysis results and
the histograms.
[Type 2]: Prints 20 analysis results.
[Type 3]: Prints only CBC8 analysis
results.
[Ext.Print]*3
[Connect] [Enable]/[Disable]
[Type] [ESC/P]/[PCL5]/[Bitmap (for PC)]
[GP AutoPri.] [All Data]/[Error Data]/[Disable]
[Bitmap (for PC)]*4
[IP Address] Numeric input:
0 - 255 (common to all columns)
Default: “0.0.0.0”
[Port Number] Numeric input: 0 - 9999
Default: “0”
*1: Common parameters to the internal/external printer
*2: Parameters for the internal printer
*3: Parameters for the external printer
*4: Only available when [Bitmap (for PC)] is selected in [Type].
Revised January 2017
Network
Address and other necessary settings can be made here for use of
LAN (Ethernet) port to communicate host computer. In addition, the
MAC address can be checked at this screen. For details, consult
network administrator at your laboratory.
Client
Parameter Setting
[IP Address] Numeric input:
0 - 255 (common to all columns)
Default: “192.168.0.100”
[Network Mask] Numeric input:
0 - 255 (common to all columns)
Default: “255.255.255.0”
[Default Gateway] Numeric input:
0 - 255 (common to all columns)
Default: “0.0.0.0”
Host
Parameter Setting
[IP Address] Numeric input:
0 - 255 (common to all columns)
Default: “192.168.0.20”
[Port Number] Numeric input: 0 - 9999
Default: “5006”
Note:
Numeric input exceeding the upper limit is replaced with
the upper limit value in any parameters other than [Port
Number]. Revised January 2017
Information
In case the password has been forgotten, contact your
local Sysmex service representative.
Note:
If a password has been set, the password input screen will
appear. Enter the password.
Revised January 2017
Information
If the New Password and the Retype Password are
not identical, the password setting error message will
appear. Re-enter the password into both boxes.
Note:
If a password has been set, the password input screen will
appear. Enter the password.
Risk of Infection
To avoid the risk of infections, wear protective
garments and gloves for all cleaning or maintenance
work. After completion of work, wash hands with
disinfectant. Otherwise, there is a risk of infection by
pathogens.
Daily
Weekly
As-needed maintenance
Caution!
If the Shutdown sequence is not performed, protein
may build up inside the instrument. This can cause
incorrect analysis results or damage the instrument.
Note:
• If 24 hours have passed and Shutdown has not been
performed, a message appears prompting the operator to
perform Shutdown.
• It takes approx. 5 minutes to complete the Shutdown
sequence.
Start switch (2) Set CELLCLEAN to the sample probe, and in that condition,
press the start switch.
While [Aspirating] is being displayed on the screen, keep
holding CELLCLEAN in the same status, as long as the “beep”
is present.
Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water. Otherwise, it can damage the
skin or clothes.
Note:
Once the Shutdown sequence is started, it cannot be
canceled anymore.
Caution!
• When analysis starts, the status reads [Aspirating].
When the status display [Aspirating] changes to
[Running], the CELLCLEAN container can be
removed safely.
Do not remove the CELLCLEAN container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the CELLCLEAN
container by that time.
• To remove the CELLCLEAN container, lower it straight
down. Take care not to bend the sample probe.
Risk of Infection
When discarding the trap chamber liquid, always wear
rubber gloves. After completion of work, wash hands
with disinfectant. If your hands are contaminated by
the blood, etc., infection of bacteria can occur.
Caution!
• If liquid collects everyday, the hydraulic system may
have failed. Contact your Sysmex technical
representative.
• Pay attention to the direction of the float in the
chamber. Place it with its pointed end facing upward.
Revised January 2017
Risk of Infection
When cleaning the SRV tray, always wear rubber
gloves. After completion of work, wash hands with
disinfectant. If your hands are contaminated by blood,
etc., infection of bacteria can occur.
(1) Turn off the power of the main unit and wait approximately 30
seconds.
(2) Open the front cover of the main unit.
(3) Remove the SRV tray.
Caution!
When removing the SRV tray, take care not to loosen
Probe fixing the probe fixing screw. If analysis is made with the
screw
screw loosened, air can enter the system and affect
SRV tray the data.
Caution!
After mounting the SRV tray, make sure the probe
fixing screw is not loose. If analysis is made with the
screw loosened, air can enter the system and affect
the data.
Information
Mount the SRV tray properly as to the face/bottom
and the direction.
12.6 Clean TD
When the main power switch is turned ON, and if either the counter
value exceeds 1,500, or if 1 month has passed since the last
maintenance, a message will appear prompting the operator to
perform periodic maintenance (TD cleaning).
Press the [Cancel] button to continue start up without executing
the cleaning TD operation. Until the TD is cleaned, the message
is displayed at start-up.
When this message is displayed, perform the TD cleaning
according to the following procedures.
Note:
Even when the above-mentioned message is not displayed,
TD cleaning can be executed by pressing the [Maint.]
button of the menu screen, then pressing the [Clean
Transducer] button of the maintenance screen.
Note:
The transducer cover with spring close hinge automatically
closes when you let go of the cover.
Filler
(3) Using the filler provided with the unit, pour approximately 1
mL each of CELLCLEAN into the WBC transducer and RBC
transducer.
Risk of Infection
When opening the transducer cover, wear protective
garments and gloves. After completion of work, wash
hands with disinfectant. If your hands are
contaminated by blood, etc., there is a risk of infection
by pathogens.
Revised January 2017
Warning!
• Do not press the start switch while pouring
CELLCLEAN into the TD chamber. Otherwise, there
is a risk of electric shock.
• CELLCLEAN is a strong alkaline cleaning solution.
Do not mix it with any acidic substances. Also, it
should not come in contact with skin or clothing. If
the skin or clothes should come in touch with it, flush
it away using plenty of water. Otherwise, it can
damage the skin or clothes.
Caution!
Do not pour more than 1 mL of detergent
(CELLCLEAN) into the chamber. It may overflow,
possibly causing electric shocks or leakage.
Information
Take care not to have detergent (CELLCLEAN)
adhere to the chamber side wall.
Note:
When executing the TD cleaning from the maintenance
menu screen, the TD cleaning starting screen will be
displayed after the preprocessing sequence is executed.
Then press the start switch.
Information
When the cleaning is performed, the detector counter
(number of cycles since last cleaning of TD) is
automatically reset.
Revised January 2017
Note:
Even when the above-mentioned message is not displayed,
waste chamber cleaning can be executed by pressing the
[Maint.] button of the menu screen, then pressing the
[Clean W. Chamber] button of the maintenance screen.
Start switch (1) Set CELLCLEAN to the sample probe, and in that condition,
press the start switch.
While [Aspirating] is being displayed on the screen, keep
holding CELLCLEAN in the same status, as long as the “beep”
is present.
Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water to avoid injury or damage.
Otherwise, it can damage the skin or clothes.
Revised January 2017
Caution!
• When analysis starts, the status reads [Aspirating].
When the status display [Aspirating] changes to
[Running], the CELLCLEAN container can be
removed safely.
Do not remove the CELLCLEAN container from the
sample probe while [Aspirating] is displayed.
Otherwise, there is a possibility that proper aspiration
cannot be performed.
• Several seconds after the buzzer sounds “beep,
beep” and [Running] appears on the screen, the
rinse cup lowers. Remove the CELLCLEAN
container by that time.
• To remove the CELLCLEAN container, lower it
straight down. Take care not to bend the sample
probe.
Information
When the cleaning is performed, the detector counter
(number of cycles since last cleaning of waste
chamber) is automatically reset.
Revised January 2017
Risk of Infection
When cleaning the SRV, always wear rubber gloves.
After completion of work, wash hands with
disinfectant.
If your hands are contaminated by blood, etc.,
infection of bacteria can occur.
Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water.
Otherwise, it can damage the skin or clothes.
Caution!
Before turning the power off, always press the [OK]
button, making the instrument ready to be turned off.
Note:
When cleaning the SRV before the above message is
displayed, reset the SRV counter (see “12.14 Reset SRV
cycle counter”).
Revised January 2017
(2) Turn off the power of the main unit and wait approximately 30
seconds.
(3) Open the front cover of the main unit.
Caution!
When removing the SRV tray, take care not to loosen
the probe fixing screw.
SRV tray If analysis is made with the screw loosened, air can
Probe enter the system and affect the data.
fixing
screw
(5) Gently push down the rinse cup using both hands.
Sample probe
Make sure the rinse cup is removed completely from the sample
probe.
Caution!
If the rinse cup is not completely removed from the
sample probe, there is a possibility that the sample
Rinse cup probe may bend when the SRV is removed.
Loosen
Caution!
• Take care not to pull out the SRV excessively. This is
to prevent applying excess force to the tube
connected to the SRV.
SRV
• When removing the SRV, take care not to bend the
sample probe.
Revised January 2017
Fixed valve
Caution!
When removing each valve component, reagent could
leak from the tube. If it does, wipe it clean using cloth.
If left as it is, it can cause current leakage or electric
shocks.
Rotary valve
Note:
The valve components are in close contact with one
another. They can be easily removed when you slide each
one while twisting.
(9) Clean the rotary valve using distilled water or 1:10 dilution of
CELLCLEAN detergent. After cleaned with CELLCLEAN,
always clean it with distilled water.
(10) Clean the contact surfaces of the fixed and rotary valves using a
gauze moistened with distilled water. By using CELLCLEAN
together with distilled water, stuck objects, dirt, etc. can be
removed easily.
Caution!
• Take care not to inflict flaws or scratches on valve
surfaces, since flaws or scratches can cause blood
leakage and correct analysis results may not be
obtained.
• Do not use any other materials, like cleaning tissues
or Q-tips for cleaning which could loose parts of its
substance.
Information
Do not use any detergent other than CELLCLEAN.
Although the SRV is corrosion-resistant against
CELLCLEAN, rinse the SRV with distilled water
completely to prevent troubles to the unit or other
components.
(11) Make sure the valve contact surfaces are completely free from
dirt or dust.
Revised January 2017
Caution!
If the device is used with dirt or dust attaching on
valve contact surfaces, blood leakage can occur and
correct analysis results may not be obtained.
Information
• Mount the rotary valve with the notch facing upward
and the metal knob coming between the stoppers.
Metal knob
Guide pin for rotary valve
Stopper
Groove
Note:
Make sure, that the contact surfaces are wetted with
distilled water to ensure sealing.
(13) Mount the SRV tray to the original position and gently push up
the rinse cup to the top using both hands.
Information
• Mount the SRV tray properly as to its face/bottom
and the direction.
• Make sure the rinse cup is pushed all the way up with
the sample probe inserted in the hole. If the power is
turned on with the rinse cup staying lowered, [Rinse
motor error] will occur, making it impossible to
continue the operation.
Information
See “Blank Error” in “13. Troubleshooting” to deal with
Blank error.
Revised January 2017
(5) When the Auto Rinse and Background check are normally
completed, the Main screen will appear.
Press the [Result] button and Background check result will
appear.
Risk of Infection
When cleaning the rinse cup, always wear rubber
gloves. After completion of work, wash hands with
disinfectant. If your hands are contaminated by blood,
etc., infection of bacteria can occur.
(1) Turn off the power of the main unit and wait approximately 30
seconds.
(2) Open the front cover of the main unit.
(3) Gently push down the rinse cup using both hands.
Sample probe
Make sure the rinse cup is removed completely from the sample
probe.
Rinse cup
(4) Remove the rinse cup in the order of (1), (2), and (3) as shown
on the left.
Rinse cup
(1)
(2)
(3)
(7) Mount the rinse cup in the reverse order of removal. Route the
thin tubes around the rear of the rinse cup.
(8) Gently push up the rinse cup to the top using both hands.
Rinse cup
Information
Make sure the rinse cup is pushed all the way up with
(3)
the sample probe inserted in the hole. If the power is
(2)
turned on with the rinse cup staying lowered, [Rinse
(1) motor error] will occur, making it impossible to
continue the operation.
Risk of Infection
• Always wear protective garments and gloves when
handling the waste fluid. After completion of work,
wash hands with disinfectant. Otherwise, there is a
risk of infection by pathogens.
• When handling (disposing) the waste fluid, dispose it
appropriately in accordance to local laws and
regulations, which considers for the disposal of
medical waste and infectious waste.
Warning!
• CELLCLEAN is a strong alkaline cleaning solution.
Do not mix it with any acidic substances. Also, it
should not come in contact with skin or clothing. If
the skin or clothes should come in touch with it, flush
it away using plenty of water to avoid injury or
damage. Otherwise, it can damage the skin or
clothes.
• For disposing waste fluids, see “2.7 Disposal of
waste fluid, waste materials, and the device”.
Caution!
• Ensure that the waste container is secure and
properly connected before operating the instrument.
Waste fluid may discolor some materials.
• If the waste fluid is spilt, wipe off with the damp cloth
immediately.
• When using a used reagent container as the waste
container, make sure to clearly mark it that it is the
Revised January 2017
waste container.
Risk of Infection
Wear protective garments and gloves when cleaning
TD aperture of (draining TD chamber). After
completion of work, wash hands with disinfectant.
Otherwise, there is a risk of infection by pathogens.
(5) Turn the main power switch OFF, and wait for approx. 30
seconds.
Then disconnect the power cord.
Warning!
To avoid electrical shock, disconnect the power cord
before servicing.
Warning!
When the power is on, never open the transducer
cover.
This is to prevent possible electric shocks.
Revised January 2017
Transducer
cover
(8) Confirm that the fluid in the TD chamber has been drained.
WBC
transducer RBC transducer
Caution!
A small volume of reagent occasionally remains.
When reagent has leaked, wipe it off immediately
Plug
using a damp cloth.
If left as it is, it can cause current leakage or electric
shocks.
Aperture (10) Apply CELLCLEAN on the brush provided, and dab by lightly
prodding the brush against the TD aperture.
Brush
Warning!
CELLCLEAN is a strong alkaline cleaning solution. Do
not mix it with any acidic substances. Also, it should
not come in contact with skin or clothing. If the skin or
clothes should come in touch with it, flush it away
using plenty of water.
Otherwise, it can damage the skin or clothes.
Note:
After using the brush, wash it in water thoroughly to
remove the CELLCLEAN before storing it.
Caution!
The TD chamber plug should be mounted securely.
Otherwise, current leakage or electric shocks can occur.
Revised January 2017
(12) Close the transducer cover and main unit front cover. Then turn
on the power.
(13) Check that the blank error has not occurred.
(4) Press the center of “+” mark on the screen each time the “+”
mark is displayed.
The “+” mark will appear on the LCD in the following order: at
the center, the upper left, the lower left, the lower right, and the
upper right.
After completion of all “+” marks input, the calibration LCD
confirmation dialog screen will appear.
Revised January 2017
Press the [OK] button to apply the calibration, and the Main
screen will appear.
Press the [Cancel] button to return to the Main screen without
applying calibration.
Information
• If the input position was outside a regulated range,
the calibration error message will appear, and the
calibration will be discontinued.
• When calibration is performed and a calibration error
occurs frequently, there may be a problem with the
touch panel. Contact your Sysmex service
representative for further assistance.
Note:
• When the main power switch is turned ON, and if either the
counter value exceeds 4,500 or if 3 months have passed
since the last maintenance, a message will appear
prompting the operator to perform periodic maintenance
(SRV cycle counter reset).
• For details on SRV cleaning methods, see “12.8 Clean
SRV”.
Note:
When an error has occurred, press in the error dialog to check pressure or vacuum value on the
action message screen.
(See “13. Troubleshooting”)
Revised January 2017
(1) Display the status display screen and check the current pressure
in the [Pressure] column.
For details about methods to display the status display screen,
see “12.2 Check instrument status”.
(2) Loosen the regulator locking nut on the left side of the unit.
(3) While watching the pressure and vacuum indication on the
status display screen, turn the adjusting knob to regulate
pressure and vacuum.
Low
Turn the adjusting knob clockwise to increase pressure and
vacuum.
Loosen
(1) Display the status display screen and check the current vacuum
in the [Vacuum] column.
For details about methods to display the status display screen,
see “12.2 Check instrument status”.
(2) By turning counterclockwise, loosen the locking nut for the
bellows unit on the left side of the unit.
(3) While watching the pressure and vacuum indication on the
status display screen, turn the adjusting knob to regulate
Low High
pressure and vacuum.
Turn the adjusting knob clockwise to increase pressure and
vacuum.
Risk of Infection
Always wear protective garments and gloves when
replacing reagents. After completion of work, wash
hands with disinfectant. Otherwise, there is a risk of
infection by pathogens.
(1) Make ready a new reagent and make sure that it has not passed
its expiration date.
Caution!
• Leave the reagents at room temperature (15 -
30°C) for at least 24 hours or longer before using.
If a reagent that has arrived recently is used, a
correct analysis result may not be obtained.
• Use the reagent at 15 - 30°C. When analyzed with
reagent of a temperature higher than 30°C or lower
than 15°C, a correct analysis result may not be
obtained.
• Always use new reagents.
• Do not use any left-over reagents.
• Do not allow the reagents to freeze.
• Take care to prevent dust, dirt, bacteria, or other
materials from entering the reagent after it is
opened. Otherwise, there is a possibility that
proper analysis cannot be performed.
Shelf life after first opening
CELLPACK 60 days
STROMATOLYSER-WH 90 days
Revised January 2017
Reagent container
Caution!
• Take care not to touch the pipe that enters the
reagent with your hands, or to allow dust or other
substances to adhere to them. If such substances
adhere to the pipe, first wash the substance off with
reagent before attaching the container spout kit.
Otherwise, there is a possibility that proper analysis
cannot be performed.
• Take sufficient care to prevent the reagent from
spilling. If the reagent spills, immediately wipe it off
with a damp cloth or similar material. The reagent
may cause discoloration of surfaces.
Information
Make sure to read [Reagent code2]. Reading
[Reagent code] will result in an error.
Note:
If an input error or reading error occurs, the reagent bar
code reentry confirmation dialog appears. The value that
was entered last time is displayed in gray. Pressing the
[Reentry] button turns the CODE display column blank
and allows reentry of the reagent bar code.
Information
If the data records exceed 100, the oldest data is
automatically deleted.
Replacement logs for individual reagents are displayed on the reagent replacement history screen.
When the reagent replacement history screen is displayed, the cursor appears on the latest data.
The reagent replacement history screen is consisted of 4 screens, and the following information is displayed
on the individual screens:
First reagent replacement history screen Replaement date and time, lot No., expiration date
Second reagent replacement history screen Serial No., product code (product name), shelf life after first opening
Third reagent replacement history screen Manufacturer or distributor
Fourth reagent replacement history screen Address of the manufacturer or distributor
Reagent name
Reagent name: Indicates the name of the reagent whose replacement log is
displayed on the screen. [CELLPACK] is displayed for
CELLPACK and [S.LYSER] for STROMATOLYSER-
WH.
Replacement log No.: Numbered to run from the oldest to the newest. The number
of up to “100” is displayed.
Information on the reagent replaced: Displays the information on the reagents that have been
replaced for individual log numbers.
[More]: Changes the screen to STROMATOLYSER-WH
replacement logs when displaying the CELLPACK
replacement log screen, and to CELLPACK replacement
logs when displaying STROMATOLYSER-WH
replacement log screen.
[IP]: Prints 10 replacement logs that are displayed on the screen.
Revised January 2017
Warning!
Before replacing the fuse, always turn off the power
and disconnect the power cord.
This is to prevent possible electric shocks.
Caution!
For continued protection against risk of fire, use the
fuse of the specified type and rating.
Fuse cap holder
Notch This is to prevent possible smoke.
Information
When the tip of printer paper extends from the upper
part of the internal printer, cut off the paper and then
open the front cover.
Note:
When any printer paper remains, remove it together with
New printer paper the paper core.
(Printing Paper
No. 3)
(4) Pass the printer paper through along the paper guides.
Paper
guide
Revised July 2017
Information
• Be sure to set the printer paper straight in the right
direction. If the printer paper is crooked, the paper
may jam.
• Make sure the printer cover is securely closed.
If the cover is not securely closed, a printing error or
Printer head
incorrect output may result.
Caution, Hot!
The printer head becomes hot. Use caution.
Caution!
Static electricity may damage the printer head. Do not
touch with hands.
(6) Cut off any printer paper extending from the upper part of the
printer.
Note:
It is recommended to always keep a sufficient amount of
the following supplies and consumables available. This will
assure that your instrument is available for use.
Reagents list
Note:
A 20 L or 10 L Cubitainer spout kit is required when you use CELLPACK.
For details, contact your Sysmex service representative.
Consumable list
13. Troubleshooting
If the instrument shows any signs that indicate a malfunction during
operation, be sure to first check “13.1 When you suspect an error” on
the following pages. If the corresponding item is not found, or if the
procedure listed under “Action” does not eliminate the signs of
trouble, contact your Sysmex service representative.
Other errors are indicated by a beep and a message is then
displayed on the LCD screen.
If an error affects only a specific analysis result, it will be
marked by a flag.
Warning!
Disconnect the power cord before opening the
instrument.
Otherwise there is a risk of personal injury by
electrical shock and possible damage to the
instrument.
Information
• If you are unable to rectify the error, contact your
Sysmex service representative for further assistance.
Before doing so, make a note of the exact ERROR
CODE in the Help screen to enable your service
representative to provide assistance quickly.
• In case of a power failure during operation, turn the
main power switch OFF.
Revised January 2017
Trouble Action
The logo appears on the LCD The program card may have come out of the slot.
screen, however the Main Turn the main power switch OFF, and check that the program card is
screen does not appear. securely inserted in the card slot at the back of the instrument. Then turn
the main power switch ON again.
If the error persists, contact your Sysmex service representative.
The instrument is switched Check if power cord is plugged in properly.
ON but will not start. Check if the fuse(s) are blown.
Use another appliance to check if the outlet is live.
After turning the main power A memory error may have occurred. Turn the main power switch OFF,
switch ON, the LCD screen wait 1 to 2 minutes, then turn the main power switch ON again.
remains blank. If the error persists, contact your Sysmex service representative.
Mechanical operation is heard, Check that the LCD screen contrast is set correctly.
but no display appears on
LCD screen.
Fluid leaks from the Turn the main power switch OFF and wipe off the leaked fluid.
instrument. If fluid leaks persist after the main power switch is turned ON, contact
your Sysmex service representative.
Risk of Infection
Wear protective garments and gloves when working.
After completion of work, wash hands with
disinfectant.
If your hands are contaminated by blood, etc.,
infection of bacteria can occur.
General
1. Pressure/Vacuum Errors
0.05MPa Pressure Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
–0.0333MPa Vacuum Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Pressure/Vac Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
2. Chamber Errors
Waste not drained. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Replace CELLPACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Replace STROMATOLYSER . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
CELLPACK expired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
S.LYSER expired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
3. Motor Errors
Rinse motor error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Rinse MC error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
4. TD Errors
Aperture Clog (WBC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Aperture Clog (RBC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
5. Temperature Errors
Room Temp(H) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
Room Temp(L) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
6. Analysis Errors
Blank Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
PLT Smp’g Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
RBC Smp’g Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
WBC Smp’g Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
PLT Noise Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
RBC Noise Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
WBC Noise Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
HGB Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
WBC Analysis Err . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
RBC Analysis Err. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
Revised January 2017
7. Memory Errors
RAM Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
ROM Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
Stored Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
Settings Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
QC Data Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
8. Others
QC(L-J) Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
QC(X-bar) Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
QC Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
9. Maintenance Errors
Clean the SRV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
Clean Waste Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
Clean Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
13.3 Error messages, possible causes and actions to revolve the error
Note:
An error subcode may be displayed after the error code.
The subcode is for Sysmex service representative use only.
1. Pressure/Vacuum Errors
2. Chamber Errors
be performed.
3. Motor Errors
4. TD Errors
5. Temperature Errors
6. Analysis Errors
Error Message Blank Error (411010)
(Error Code)
Cause Background counts did not fall below the acceptable level during the background
check due to the following reason(s):
Dirty aperture
Dirty HGB flow cell
Bubbles mixing
Faulty reagent
Action Auto Rinse
Follow the instructions in the “Troubleshooting on the screen” below.
Clean TD.
Refer to “12.6 Clean TD” or “12.12 Clean aperture of TD chamber (drain TD
chamber)”.
Clean SRV.
Refer to “12.8 Clean SRV”.
Replenish reagent.
Faulty lyse will affect background for WBC or HGB. In case diluent is faulty,
it will affect all parameters, notably PLT background count.
Troubleshooting Press the [Execute] button to clear the error, and the auto
on the screen rinse program is executed.
Note Ready for analysis (although the next sample could be affected)
Revised January 2017
7. Memory Errors
8. Others
9. Maintenance Errors
When the TD rinse sequence has been completed, the cycle counter is
automatically reset.
Note:
Have the error messages printed out before contacting your
Sysmex service representative.
Note:
An error subcode may be printed after the error code.
The subcode is for Sysmex service representative use only.
Revised January 2017
14.1 Specifications
Operating Ambient temperature: 15°C to 30°C (same for the supplied reagent temperature)
Environment Relative humidity: 30% to 85%
Atmospheric pressure: 70 - 106 kPa
Operating altitude: Maximum 3,000 m
Contamination Level 2
Impulse Resistance II
(Excess voltage)
category
Usage location Indoor usage only
Storage Ambient temperature: -10°C to +60°C
(transportation) Relative humidity: 30% to 95% (non condensation/keep dry)
condition
Atmospheric pressure: 70 - 106 kPa
Analysis parameters WBC (Number of leukocytes), RBC (Number of erythrocytes),
HGB (Hemoglobin), HCT (Hematocrit value), MCV (Mean RBC volume),
MCH (Mean RBC hemoglobin), MCHC (Mean RBC hemoglobin concentration),
PLT (Platelet), RDW-SD (RBC distribution width - SD),
RDW-CV (RBC distribution width - CV), PDW (Platelet distribution width),
MPV (Mean platelet volume), P-LCR (Large platelet ratio), PCT (Plateletcrit),
LYM% (W-SCR), MXD% (W-MCR), NEUT% (W-LCR), LYM# (W-SCC),
MXD# (W-MCC), NEUT# (W-LCC)
Display range WBC 0.0 - 299.9 × 103/µL
RBC 0.00 - 19.99 × 106/µL
HGB 0 - 25.0 g/dL
PLT 0 - 1999 × 103/µL
Analysis range WBC 1.0 - 99.9 × 103/µL
RBC 0.3 - 7.0 × 106/µL
HGB 0.1 - 25.0 g/dL
HCT 10.0 - 60.0 %
PLT 10.0 - 999 × 103/µL
Background limits WBC 0.3 × 103/µL or less
RBC 0.02 × 106/µL or less
HGB 0.1 g/dL or less
PLT 10 × 103/µL or less
Revised January 2017
Precision Values are indicated as variation coefficient (with 95% reliability limit) when
(repeatability): peripheral blood or control blood is analyzed more than 10 times continuously.
Whole blood mode WBC 3.5% or less (4.0 × 103/µL or more)
RBC 2.0% or less (4.00 × 106/µL or more)
HGB 1.5% or less
HCT 2.0% or less
MCV 2.0% or less
MCH 2.0% or less
MCHC 2.0% or less
PLT 6.0% or less (100 × 103/µL or more)
LYM% 15.0% or less
MXD% 30.0% or less (12 W-MCR% or more)
NEUT% 15.0% or less
LYM# 15.0% or less
MXD# 30.0% or less (1.0 × 103/µL or more)
NEUT# 15.0% or less
RDW-CV 4.0% or less
RDW-SD 4.0% or less
PDW 12.0% or less
MPV 5.0% or less
P-LCR 20.0% or less
PCT 9.0% or less
Revised January 2017
Precision Values are indicated as variation coefficient (with 95% reliability limit) when
(repeatability): peripheral blood or control blood is analyzed more than 10 times continuously.
Pre-diluted mode WBC 6.0% or less (4.0 × 103/µL or more)
RBC 3.0% or less (4.00 × 106/µL or more)
HGB 2.5% or less
HCT 3.0% or less
MCV 3.0% or less
MCH 3.0% or less
MCHC 3.0% or less
PLT 9.0% or less (100 × 103/µL or more)
LYM% 25.0% or less
MXD% 45.0% or less (12 W-MCR% or more)
NEUT% 25.0% or less
LYM# 25.0% or less
MXD# 45.0% or less (1.0 × 103/µL or more)
NEUT# 25.0% or less
RDW-CV 6.0% or less
RDW-SD 6.0% or less
PDW 18.0% or less
MPV 7.5% or less
P-LCR 30.0% or less
PCT 13.5% or less
Accuracy: Mean values when calibrator is analyzed more than 10 times continuously are
Whole blood mode within the following ranges against the displayed values.
WBC ±3% or ±0.2 × 103/µL
RBC ±2% or ±0.03 × 106/µL
PLT ±5% or ±10 × 103/µL
Accuracy: Mean values when calibrator is analyzed more than 10 times continuously are
Pre-diluted mode within the following ranges against the displayed values.
WBC ±5% or ±0.3 × 103/µL
RBC ±3% or ±0.05 × 106/µL
PLT ±8% or ±15 × 103/µL
Revised January 2017
Linearity: The residual or residual rate against the values analyzed in whole blood mode is
Whole blood mode shown.
WBC ±0.3 × 103/µL (1.0 - 9.9 × 103/µL)
±3% (10.0 - 99.9 × 103/µL)
RBC ±0.03 × 106/µL (0.3 - 0.99 × 106/µL)
±3% (1.00 - 7.00 × 106/µL)
HGB ±0.2 g/dL (0.1 - 9.9 g/dL)
±2% (10.0 - 25.0 g/dL)
HCT ±1.0HTC% (10.0 - 33.3%)
±3% (33.4 - 60.0%)
PLT ±10 × 103/µL (10 - 199 × 103/µL)
±5% (200 - 999 × 103/µL)
(However, RBC < 7.00 × 106/µL)
Carryover WBC: 3% or less
RBC: 1.5% or less
HGB: 1.5% or less
HCT: 1.5% or less
PLT: 5% or less
Power supply AC120V/230V/240V±10% (50/60Hz)*
* Refer to the instrument’s name plate for the rated voltage.
Power consumption Approx. 200 VA or less
Noise level 55 dB or less
Excludes sounds during rinse cup discharge, printer printing noise and alarm
sounds.
Heat compensation Approx. 785 BTU/h (198 kcal/h)
required
Dimensions Main Unit: 420 (W) × 355 (D) × 480 (H) mm
Weight Main Unit: Approx. 30.0 kg
Protection type Class of electric shock protection measures: Class I Equipment
Class of electric shock protection levels: Class B Equipment
EMC This equipment is in conformity to the following IEC (EN) standard.
(Electro-magnetic IEC 61326-1: 97+A1: 98 (EN 61326: 97+A1) Electrical equipment for
compatibility) measurement, control and laboratory use -EMC requirements-
- EMI (Class A)
- EMS (Minimum Immunity test requirements)
EMC Conformity IEC61326-2-6:2005
Assessment EMI:ClassA
Standards
Revised January 2017
WBC
If any of the following is present, the system may erroneously report a low white blood cell count.
Leukocyte aggregation
If any of the following is present, the system may erroneously report a high white blood cell count.
Possibility of PLT clumps
Lyse resistant erythrocytes
Erythrocyte aggregation (cold agglutinin)
Cryoprotein
Cryoglobulin
Fibrin
Giant platelets (platelets > 1,000,000/µL)
RBC
Where the following are present, the system may erroneously report a low red blood cell count.
Erythrocyte aggregation (cold agglutinin)
Microerythrocytes
Possibility of fragmented RBCs
If any of the following is present, the system may erroneously report a high red blood cell count.
Leukocytosis (> 100,000/µL)
Giant platelets (platelets > 1,000,000/µL)
HGB
If any of the following is present, the system may erroneously report a high haemoglobin concentra-
tion.
Leukocytosis (> 100,000/µL)
Lipemia
Abnormal protein
Revised January 2017
HCT
If any of the following is present, the system may erroneously report a low hematocrit value.
Erythrocyte aggregation (cold agglutinin)
Microerythrocytes
Possibility of fragmented RBCs
If any of the following is present, the system may erroneously report a high hematocrit value.
Leukocytosis (> 100,000/µL)
Severe diabetes
Uremia
Spherocytosis
PLT
If any of the following is present, the system may erroneously report a low platelet count.
Possibility of PLT clumps
Pseudothrombocytopenia
Giant platelets
If any of the following is present, the system may erroneously report a high platelet count.
Microerythrocytes
Possibility of fragmented RBCs
Fragmented leukocytes
Cryoprotein
Cryoglobulin
Note:
A numeric value abnormal flag is printed to the right of
each value on the list printer (LP).
Revised January 2017
No. Explanation
1 Bar code reader unit
Connection procedure
(1) Turn the main power switch OFF.
(2) Insert the other end of the connection cable into the bar code
reader connector port at the back of the instrument.
Bar code
reader
connector
port
Trigger switch
Hardware specifications
Software specifications
S E
T T
X X
Order of transmission
When using bar code labels, labels with specifications that match the bar code reader for the XP-300
must be used.
This section explains the bar code label specifications.
Note:
Following is an explanation of the typical bar code label specifications.
The actual specifications may differ depending on the symbology, print quality, and number
of digits.
Specifications for JAN codes will also be somewhat different.
For details, contact your Sysmex service representative.
Symbologies used
The symbologies and check digits which can be used are listed below.
Warning!
If the sample bar code is used, use a check digit whenever possible.
If a check digit is not used, the chances of the bar code being misread increase.
Surface reflection
A laminated label cannot be read.
MAX
MIN
Bar element
Bar height
Check digit
A check digit can be added to further increase the reliability of the ID number which is read.
Following is an example of the methods used to calculate the check digit of modulus 11 and
weighted modulus 11 for a sample ID number of “258416”.
(1) Modulus 11
1) A weight is assigned to each digit.
2 5 8 4 1 6
× × × × × ×
Weight 7 6 5 4 3 2
14 30 40 16 3 12
2) The results of multiplication are all added together. The result is S.
S = 14 + 30 + 40 + 16 + 3 + 12 = 115
3) A remainder is found by dividing S by 11. The complement of this remainder is then found. The
11-complement becomes the check digit value to be added.
115 / 11 = 10 (remainder = 5)
11 - 5 = 6 The check digit is 6.
All alphabet and symbol characters other than numbers 0 to 9 are considered for calculation to
be 0. If the remainder is 0 when S is divided by 11, or if the result of check-digit calculation is
10, then the check digit is 0.
2 5 8 4 1 6
× × × × × ×
Weight 8 4 5 3 6 2
16 20 40 12 6 12
3) A remainder is found by dividing S by 11. The complement of this remainder is then found. The
11-complement becomes the check digit value to be added.
106 / 11 = 9 (remainder = 7)
11 - 7 = 4 The check digit is 4.
All alphabet and symbol characters other than numbers 0 to 9 are considered for calculation to
be 0. If the remainder is 0 when S is divided by 11, or if the result of check-digit calculation is 0,
then the check digit is 0.
Note:
The weight of digits 13 to 15 is 0.
Type4 (Dutch SI) Type5 (Standard SI) Type6 (Hong Kong SI)
Flow of analysis: Flow of each analysis parameter on the main unit and analysis
method for particle distribution are described.
Detection principle
This instrument performs blood cell count by DC detection method.
DC detection method
Blood sample is aspirated, measured to a predetermined volume, diluted at the specified ratio, then
fed into each transducer.
The TD chamber has a minute hole called the aperture. On both sides of the aperture, there are the
electrodes between which flows direct current. Blood cells suspended in the diluted sample pass
through the aperture, causing direct current resistance to change between the electrodes. As direct
current resistance changes, the blood cell size is detected as electric pulses.
Blood cell count is calculated by counting the pulses, and a histogram of blood cell sizes is plotted by
determining the pulse sizes. Also, analyzing a histogram makes it possible to obtain various analysis
data.
DC
DC Supply
TD Chamber
Resistance
External Electrode +
1.960 mL
4.0 µL (1:500)
1.994 mL
1.0 mL WBC TD Chamber
WBC/HGB Lyse
SRV 6 µL (1:500)
(1:500)
<Pre-diluted Mode>
1.99792 mL
2.08 µL (1:25,000)
1.922 mL
1.0 mL WBC TD Chamber
WBC/HGB Lyse
78 µL (1:1,000)
SRV
(1:1,000)
CBC analysis
In WBC and HGB analysis, the volume of WBC and hemoglobin in the blood are measured. The flow
of WBC/HGB analysis is described below:
SRV
WBC Transducer
Tube or Micro tube
Whole Blood Mode: 50 µL
Pre-diluted Mode: 1:26 Diluted Sample 200 µL
• Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This sample is
aspirated from the sample probe into the SRV.
(2) 78 µL of diluted blood measured by the SRV is transferred to the WBC TD chamber along with
1.922 mL of diluent. At this time, 1.0 mL of WBC/HGB lyse is added to prepare 1:1,000
dilution sample.
When the solution is made to react in this status for approximately 10 seconds, RBC is
hemolyzed and platelets shrink, with WBC membrane held as they are. At the same time,
hemoglobin is converted into red colored methemoglobin.
(3) Of the diluted/hemolyzed sample in the WBC TD chamber, approximately 1 mL is transferred
to the HGB flow cell.
(4) 500 µL of sample in the WBC TD chamber is aspirated through the aperture. The pulses of the
blood cells when passing through the aperture are counted by the DC detection method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting diode (LED)
is applied to the sample in the HGB flow cell. Concentration of this sample is measured as
absorbance. This absorbance is compared with that of the diluent alone that was measured
before addition of the sample, thereby calculating HGB (hemoglobin value).
Revised January 2017
In RBC/PLT analysis, RBC and platelet count in the blood are measured. The flow of RBC/PLT
analysis is described below:
RBC/PLT Transducer
(1) Blood is aspirated from the sample probe into the SRV.
(2) 4.0 µL of blood measured by the SRV is diluted into 1:500 with 1.996 mL of diluent and brought
to the mixing chamber as diluted sample. (1st step dilution)
(3) Out of the 1:500 dilution sample, 40 µL is measured by the SRV, diluted into 1:25,000 with
1.960 mL of diluent, then transferred to the RBC/PLT TD chamber. (2nd step dilution)
(4) 250 µL of the sample in the RBC/PLT TD chamber is aspirated through the aperture. At this
time, RBC and PLT are counted by the DC detection method.
At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection method.
Revised January 2017
• Pre-diluted Mode
SRV
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This sample is
aspirated from the sample probe into the SRV.
(2) 2.08 µL of diluted blood measured by the SRV is transferred in 1.99792 mL of diluent to the
RBC/PLT TD chamber, and is made into 1:25,000 dilution sample.
(3) Of the sample in the RBC/PLT TD chamber, 250 µL is aspirated through the aperture. At this
time, RBC and PLT are calculated by the DC detection method.
At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection method.
Revised January 2017
RBC constant (mean RBC volume, mean RBC hemoglobin, mean RBC hemoglobin concentration) is
calculated from RBC, HGB, and HCT.
HCT (%)
MCV (fL) = 6 ×10
RBC (×10 /µL)
HGB (g/dL)
MCH (pg) = 6 ×10
RBC (×10 /µL)
HGB (g/dL)
MCHC (g/dL) = ×100
HCT (%)
WBC, RBC, and PLT are discriminated and calculated by the following blood cell discriminator.
WBC discriminator
As to WBC LOWER discriminator and UPPER discriminator, the optimum position in 30 - 60 fL and
300 fL, respectively, are automatically determined by the microcomputer. WBC is calculated from
the particle counts between this LOWER discriminator and UPPER discriminator.
RBC discriminator
As to RBC LOWER discriminator and UPPER discriminator, the optimum position in 25 - 75 fL and
200 - 250 fL, respectively, are automatically determined by the microcomputer. RBC is calculated
from the particle counts between this LOWER discriminator and UPPER discriminator.
PLT discriminator
As to PLT LOWER discriminator and UPPER discriminator, the optimum position in 2 - 6 fL and 12
- 30 fL, respectively, are automatically determined by the microcomputer. PLT count is calculated
from the particle counts between this LOWER discriminator and UPPER discriminator.
Revised January 2017
Analysis of histogram
Analysis of histogram allows use of the flagging system that suggests sample error or instrument
error.
Histograms of WBC, RBC, and PLT can be calculated respectively within the ranges given below.
1. WBC Histogram
The WBC histogram is discriminated into small, middle, and large WBC by 3-part differential
method using 4 discriminators. The LOWER discriminator (LD) is automatically determined at an
optimum position between 30 and 60 fL. The UPPER discriminator (UD) is fixed at 300 fL, which is
used as the monitor for histogram error. The WBC histogram troughs in the (LD)-to-(UD) range are
determined; the 1st one is defined TROUGH Discriminator 1 (T1) and the 2nd one TROUGH
Discriminator 2 (T2).
• WBC Histogram
LD T1 T2 UD
WBC
Caution!
WBC research parameters are for research purposes only.
Do not use analysis results for WBC research parameters in patient diagnosis.
Each parameter shows the following particle counts contained in 1 µL of whole blood.
ResearchW: Particle counts between LD and UD of the WBC histogram
ResearchS: Particle counts between LD and T1 of the WBC histogram
ResearchM: Particle counts between T1 and T2 of the WBC histogram
ResearchL: Particle counts between T2 and UD of the WBC histogram
• Print format
ResearchS, ResearchM, ResearchL: Can be printed in Type1 or Type2.
ResearchW: Can be printed in Type1, Type2 or Type3.
• Interface protocol
ResearchS, ResearchM, ResearchL: Can be output to the host computer in XP format.
ResearchW: Can be output to the host computer in XP format or pocH format.
For details, contact your local Sysmex service representative.
Revised January 2017
When the WBC histogram is normal with 3 peaks, there are a lower trough (T1) and a higher trough
(T2) between LOWER discriminator (LD) and UPPER discriminator (UD).
LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% 28.3 [%]
MXD% 17.4 [%]
NEUT% 54.3 [%]
LYM# 1.9 [×103/µL]
100 200 300 [fL] MXD# 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]
When TROUGH Discriminator (T1) or (T2) cannot be set or when frequency for a set discriminator
position is higher than the range, it is flagged as WBC histogram error. Those histogram error flags
are listed below in the order of higher priority. If more than one flag is applied, the flag of the highest
priority is taken.
WL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is
inclusion of numerous platelet agglutinations, large platelets, and etc.
T1: Lower TROUGH Discriminator, that distinguishes lymphocytes and mixed cells, cannot be not
determined.
T2: Higher TROUGH Discriminator, that distinguishes mixed cells and neutrophils, cannot be not
determined.
F1: Small cell histogram error. Relative frequency for T1 exceeds the range.
F2: Middle cell histogram error. Relative frequency for T1 or T2 exceeds the range.
F3: Large cell histogram error. Relative frequency for T2 exceeds the range.
WU: Relative frequency for UPPER discriminator (UD) exceeds the range. Applicable case is that in
which considerable leukocyte aggregation or numerous abnormal blood cells are present.
AG: The particle count equal to or less than the LD exceeds a prescribed range. Probable cause is
platelet agglutination, which does not alter WBC count but may result in decreased platelet
count. Therefore, this flag is added to the PLT parameter.
Revised January 2017
LD T1 T2 UD
WBC WL 8.5 [×103/µL]
WBC
LYM% WL 39.3 [%]
MXD% WL 17.6 [%]
NEUT% WL 43.1 [%]
LYM# WL 3.4 [×103/µL]
100 200 300 [fL] MXD# WL 1.5 [×103/µL]
Revised January 2017
LD T1 UD
WBC WL 2.8 [×103/µL]
WBC
LYM% WL 45.9 [%]
MXD% WL ---.- [%]
NEUT% WL ---.- [%]
LYM# WL 1.3 [×103/µL]
100 200 300 [fL] MXD# WL ---.- [×103/µL]
NEUT# WL ---.- [×103/µL]
LD UD
WBC WL +16.4 [×103/µL]
WBC
LYM% WL ---.- [%]
MXD% WL ---.- [%]
NEUT% WL ---.- [%]
LYM# WL ---.- [×103/µL]
100 200 300 [fL] MXD# WL ---.- [×103/µL]
NEUT# WL ---.- [×103/µL]
Revised January 2017
4) 2A Histogram without T1
Although the histogram error flag is not added to WBC, all other parameters are flagged with T1
and their data are not output. Note that WBC in the graph exceeds the upper Patient Mark
Limits.
LD UD
WBC +15.4 [×103/µL]
WBC
LYM% T1 ---.- [%]
MXD% T1 ---.- [%]
NEUT% T1 ---.- [%]
LYM# T1 ---.- [×103/µL]
100 200 300 [fL] MXD# T1 ---.- [×103/µL]
NEUT# T1 ---.- [×103/µL]
LD T1 UD
WBC 5.2 [×103/µL]
WBC
LYM% F1 29.7 [%]
MXD% T2 ---.- [%]
NEUT% T2 ---.- [%]
LYM# F1 1.5 [×103/µL]
100 200 300 [fL] MXD# T2 ---.- [×103/µL]
NEUT# T2 ---.- [×103/µL]
LD T1 UD
WBC +15.2 [×103/µL]
WBC
LYM% 12.9 [%]
MXD% T2 ---.- [%]
NEUT% T2 ---.- [%]
LYM# 1.6 [×103/µL]
100 200 300 [fL] MXD# T2 ---.- [×103/µL]
NEUT# T2 ---.- [×103/µL]
LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% F1 28.3 [%]
MXD% F2 17.4 [%]
NEUT% 54.3 [%]
LYM# F1 1.9 [×103/µL]
100 200 300 [fL] MXD# F2 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]
LD T1 T2 UD
WBC 10.7 [×103/µL]
WBC
LYM% F1 20.8 [%]
MXD% F2 11.2 [%]
NEUT% F3 68.0 [%]
LYM# F1 2.2 [×103/µL]
100 200 300 [fL] MXD# F2 1.2 [×103/µL]
NEUT# F3 7.3 [×103/µL]
LD T1 T2 UD
WBC + 18.5 [×103/µL]
WBC
LYM% 9.5 [%]
MXD% F2 + 23.7 [%]
NEUT% F3 66.8 [%]
LYM# 1.1 [×103/µL]
100 200 300 [fL] MXD# F2 2.7 [×103/µL]
NEUT# F3 7.7 [×103/µL]
LD T1 T2 UD
WBC WU + 15.4 [×103/µL]
WBC
LYM% 24.5 [%]
MXD% 7.5 [%]
NEUT% 68 [%]
LYM# 3.3 [×103/µL]
100 200 300 [fL] MXD# 1.0 [×103/µL]
NEUT# 8.1 [×103/µL]
17) 7 The particle count equal to or less than LD is higher than the range.
PLT is flagged with AG and other parameters are not flagged.
1. RBC Histogram
As mentioned earlier, RBC are determined as particle counts between 2 discriminators (LD) and
(UD) which are automatically counted in the ranges of 25 - 75 fL and 200 - 250 fL, respectively. As
to histogram, check is made for relative frequency errors on respective discriminator levels, for more
than one peak, and for distribution width error.
In addition, this instrument is capable of expressing RBC distribution width (RDW) by 2 methods
below:
RDW-CV (RBC Distribution Width - Coefficient of Variation) is calculated by the formula below,
after determining points L1 and L2 for 68.26% of the entire particle area. The unit applied is %.
• Calculation of RDW-CV
L2–L1
RDW-CV(%) = ×100
L2+L1
L1 L2
RDW-SD (RBC Distribution Width - SD) is set on 20% frequency level with the peak taken as 100%.
The unit applied is fL (femto-liter = 10-15L).
• Definition of RDW-SD
100%
20%
RDW-SD
Revised January 2017
2. PLT Histogram
Platelet histogram is analyzed using 3 discriminators: 2 discriminators (LD) and (UD) - determined
automatically between 2 - 6 fL and between 12 - 30 fL, respectively -and the fixed discriminator at 12
fL. Regarding PLT histogram, check is made to see that there are no relative frequency errors at
discriminators (LD) and (UD), distribution width error, and there is a single peak.
100% P-LCR
20%
PCT(%)
MPV(fL) = ×10,000
PLT(×103/µL)
Where PCT (%) represents the value weighted with PLT frequency and is called plateletcrit or
platelet volume ratio. The analysis method used is the same as mentioned in HCT analysis principle
“RBC/PLT analysis flow” in “CBC analysis”.
When RBC histogram is not normal, a histogram error flag is added to the corresponding parameter
of the analysis value. Those histogram error flags are listed in the order of higher priority.
When 2 or more flags are applicable to a parameter, the highest-priority flag is used.
RL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is the
effect of noise, RBC morphological change, platelet coagulation, or the like.
RU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable cause is the
effect of noise.
DW: Particle distribution width error for 20% frequency with the peak taken as 100%. When the
20% frequency does not cross the histogram 2 times, this flag is attached.
RBC
RBC RL 3.57 [×106/µL]
HGB 11.5 [g/dL]
HCT RL 41.8 [%]
MCV RL +117.1 [fL]
MCH RL 32.2 [pg]
100 200 250 [fL]
MCHC RL -27.5 [g/dL]
RDW-SD RL +91.7 [fL]
PLT RL 185 [×103/µL]
RBC
RBC RU 3.57 [×106/µL]
HGB 11.5 [g/dL]
HCT RU 52.9 [%]
MCV RU +148.2 [fL]
100 200 250 [fL] MCH RU 32.2 [pg]
MCHC RU -21.7 [g/dL]
RDW-SD DW ---.- [fL]
PLT RU 185 [×103/µL]
8) 4 2 or more peaks
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As to the particle
distribution width data, RDW-CV data are output with MP flag. RDW-SD is flagged with MP
and its data are not output. In this instance, RDW-CV is out of Patient Mark Limits.
RBC
RBC 4.80 [×106/µL]
HGB 14.2 [g/dL]
HCT 41.5 [%]
MCV 86.5 [fL]
MCH 29.6 [pg]
100 200 250 [fL]
MCHC -34.2 [g/dL]
Revised January 2017
When the platelet histogram is not normal, a histogram error flag is added to the corresponding
parameter of the analysis value. Those histogram error flags - used with the particle distribution
analysis unit mounted, are listed in the order of higher priority.
When 2 or more flags are applicable to a parameter, the highest priority flag is used.
PL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is the
effect of noise and etc.
PU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable cause is the
effect of platelet agglutination, noise interference, and etc.
DW: Particle distribution width error for 20% frequency with the peak taken as 100%. When the
20% frequency does not cross the histogram 2 times, this flag is attached.
PLT
PLT PL 211 [×103/µL]
PDW PL 12.5 [fL]
MPV PL 9.3 [fL]
P-LCR PL -22.6 [%]
10 20 30 [fL]
4) 2A High UD
PLT, PDW, MPV, and P-LCR parameters are flagged with PU.
PLT
PLT PU 171 [×103/µL]
PDW DW ---.- [fL]
MPV PU ---.- [fL]
P-LCR PU ---.- [%]
10 20 30 [fL]
Revised January 2017
PLT
PLT 91 [×103/µL]
PDW DW ---.- [fL]
MPV DW ---.- [fL]
P-LCR DW ---.- [%]
10 20 30 [fL]
8) 4 2 or more peaks
PLT is not flagged. Other parameters are flagged with MP and their data are not output.
PLT
PLT 155 [×103/µL]
PDW MP ---.- [fL]
MPV MP ---.- [fL]
P-LCR MP ---.- [%]
10 20 30 [fL]
Electric system
The microprocessor in the main unit controls the hydraulic system’s solenoid valves and master
valves, thus regulating the flow of samples, reagents, and waste in the hydraulic system.
Electric signals received from various transducers go through the analogue circuit for electrical
waveform-processing, and to the microcomputer. The microcomputer converts the analogue signals
into digital signals for the calculation.
The WBC, RBC, and PLT cell signals are sent to the respective waveform-processing circuits in the
analogue circuit, where the noise in signals is eliminated to acquire the required cell signals only. The
microcomputer converts the A/D-converted cell signals into particle distribution data, and outputs
them to the printer or to the host computer.
To calculate HGB, absorbance of only the diluent (background) is deducted from samples’
absorbance. The beam that has passed through the fluid is detected by the photo diode. And the
signals is photoelectrically converted, A/D converted, and then sent to the HGB counting circuit for
the calculation of the absorbance.
Revised January 2017
14.7 Warranty
All Sysmex instruments are warranted against defective material or
workmanship for a period of 1 year, commencing on the installation
date at the customer's premises.
This warranty does not cover any defect, malfunction or damage due
to:
Accident, neglect or wilful mistreatment of the product;
Failure to use, operate, service or maintain the product in
accordance with the applicable Sysmex Instructions for Use;
Failure to use the appropriate reagents and consumables
specified for the product.
Sysmex XP-300
Day
Maintenance item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean TD chambers and
14.8 Appendix
Maintenance item
Signature Signature Signature Signature
Adjust pressure and vacuum
Clean TD
Reagent replenishing record
14-49
Technical Information
14-50
CELLPACK
Lot ID Month/Day Expiration date Signature Lot ID Month/Day Expiration date Signature
Technical Information
STROMATOLYSER-WH
Lot ID Month/Day Expiration date Signature Lot ID Month/Day Expiration date Signature
Sysmex XP-300
Revised January 2017
Technical Information
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NO WARRANTY
Index
Numerics C
–0.0333MPa Vacuum Error...................................... 13-7 Calculating the calibration value .............................. 10-9
0.05MPa Pressure Error............................................ 13-7 Calculation of RBC constant .................................. 14-28
Calibrate LCD screen ............................................. 12-23
A Calibration ................................................................ 10-1
Abbreviations ............................................................. 1-4 Calibration flow chart............................................... 10-2
Abbreviations and units used throughout this Carryover .................................................................. 14-5
manual................................................................... 1-4 CBC analysis .......................................................... 14-24
Accuracy: Pre-diluted mode ..................................... 14-4 CELLCLEAN............................................................. 4-3
Accuracy: Whole blood mode .................................. 14-4 CELLPACK................................................................ 4-1
Action message screen ............................................... 6-3 CELLPACK expired............................................... 13-10
Additional special equipment ..................................... 9-2 Check digit.............................................................. 14-17
Adjust pressure and vacuum................................... 12-26 Check instrument status............................................ 12-2
Adjusting pressure to 0.05 MPa ............................. 12-28 Check trap chamber level and discard...................... 12-5
Adjusting the contrast of the LCD screen ................ 5-17 Checking the program version.................................. 12-2
Adjusting vacuum to –0.0333 MPa ........................ 12-29 Checks prior to operation ........................................... 7-3
Alphabetical error message index ............................ 13-4 Clean aperture of TD chamber
Analysis in pre-diluted (PD) mode........................... 7-17 (drain TD chamber)........................................... 12-20
Analysis in whole blood (WB) mode ......................... 7-8 Clean rinse cup ....................................................... 12-17
Analysis modes........................................................... 7-1 Clean SRV .............................................................. 12-11
Analysis of histogram............................................. 14-30 Clean SRV tray......................................................... 12-6
Analysis of RBC/PLT histogram............................ 14-39 Clean TD................................................................... 12-7
Analysis of WBC histogram................................... 14-30 Clean TD chambers and diluted sample lines
Analysis parameters.......................................... 1-5, 14-1 (Shutdown).......................................................... 12-3
Analysis principle ..................................................... 14-2 Clean the SRV ........................................................ 13-17
Analysis range .......................................................... 14-1 Clean Transducer.................................................... 13-17
Analyzing samples.......................................... 7-15, 7-25 Clean Waste Chamber ............................................ 13-17
Aperture Clog (RBC) ............................................. 13-11 Clean waste chamber ................................................ 12-9
Aperture Clog (WBC) ............................................ 13-11 Cleaning and maintenance........................................ 12-1
Appendix ................................................................ 14-49 Composition ............................................................... 9-2
As-needed maintenance............................................ 12-1 Connect CELLPACK ................................................. 5-8
Automatic calibration ............................................... 10-4 Connect STROMATOLYSER-WH ........................... 5-9
Automatic settings of the TARGET value and Connect waste line...................................................... 5-9
LIMIT value........................................................ 9-15 Connecting the bar code reader .............................. 14-12
Automatic stop function ............................................. 6-6 Connection of a host computer, printer and
Avoiding infections .................................................... 2-3 handheld bar code reader .................................... 5-13
Connection of power cable ....................................... 5-14
Connection of reagents and waste bottle .................... 5-7
B Connection procedure............................................. 14-12
Background check ...................................................... 7-6 Consumable list ...................................................... 12-38
Background limits .................................................... 14-1 Consumption of reagent............................................ 14-2
Bar code element dimensions ................................. 14-15 Contact address........................................................... 1-2
Bar code label dimensions...................................... 14-16 Contamination Level ................................................ 14-1
Bar code reader settings.......................................... 14-13 Control material................................................ 9-1, 14-2
Basic instrument settings .......................................... 5-15 Control method selection............................................ 9-7
Basic operation area ................................................... 6-2 Control methods ......................................................... 9-5
Before installation ...................................................... 5-2
Blank Error ............................................................. 13-12
Blood cell discrimination circuit ............................ 14-29
Blood volume aspirated ............................................ 14-2
Revised January 2017
Sysmex XP-300 i
Index
ii Sysmex XP-300
Index
iv Sysmex XP-300