NormaChem-200 UM PDF

normachem 2OO
Automated Biochemistry Analyzer

Operators Manual
Norma Diagnostika GmbH

Hauptstrasse 7, 3011 Untertullnerbach, Austria
office@normadiagnostika.com
support@normadiagnostika.com
phone: +43 2233 52887
fax. +43 2233 52 88715
Version 2.1
Revision E
2014-02-11
normachem 2OO Operators Manual
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Contents
1. Introduction .................................................................................................................... 8
1.1. Symbols and labels used in this manual ........................................................... 9
1.1.1. Symbols used on the Label on the analyzer .............................................. 9
1.1.2. Pictures used in this manual.................................................................... 10
1.1.3. Safety Symbols......................................................................................... 10
1.2. Safety measures ............................................................................................. 10
1.2.1. To prevent personal injury ....................................................................... 10
1.2.2. Protection against biohazard ................................................................... 10
1.2.3. Waste liquid treatment: .......................................................................... 11
1.2.4. System function ....................................................................................... 11
1.3. Operating environment .................................................................................. 11
1.3.1. Preventing Interference by Electromagnetic Noise................................. 11
1.3.2. System operation ..................................................................................... 12
1.4. System maintenance ...................................................................................... 12
1.5. Sample handling ............................................................................................. 13
1.6. Reagent, calibration solution and blank solution ........................................... 13
1.7. Parameter setting ........................................................................................... 14
1.8. Data backup .................................................................................................... 14
1.9. Manufacturers Statement ............................................................................. 14
1.10. Repair service ................................................................................................. 15
2. System Construction ..................................................................................................... 16
2.1. Analytical unit ................................................................................................. 16
2.1.1. Sample/reagent tray ................................................................................ 17
2.1.2. Dispensing mechanism ............................................................................ 18
2.1.3. Mixing mechanism .................................................................................. 19
2.1.4. Reaction tray............................................................................................ 19
2.1.5. Optical unit .............................................................................................. 20
2.1.6. Washing unit ............................................................................................ 20
2.2. Operation unit ................................................................................................ 21
2.3. Output unit ..................................................................................................... 21
3. System installation........................................................................................................ 22
3.1. Hardware installation ..................................................................................... 22
3.2. Unpacking ....................................................................................................... 22
3.2.1. The contents of the package ................................................................... 22
3.3. Installation requirements ............................................................................... 23
3.3.1. Installation environment ......................................................................... 23
3.3.2. Power requirements ................................................................................ 23
3.3.3. Requirement for humidity and temperature .......................................... 23
3.3.4. Requirement for water supplying and draining ...................................... 24
3.3.5. Space requirements................................................................................. 25
3.3.6. Connection of accessories and serial port .............................................. 26
3.3.7. Installation and removal of the sample/reagent tray ............................. 27
3.3.8. Loading and removal of sample cup/sample tube .................................. 28
3.3.9. Loading and removal of reagent containers ............................................ 29
3.3.10. Replacing cuvettes ............................................................................ 30
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4. Software installation..................................................................................................... 31
4.1. Minimum requirements for computer hardware........................................... 31
4.2. Software installation....................................................................................... 31
5. Operating Principle of the instrument ......................................................................... 35
5.1. Mechanical operating principle ...................................................................... 35
5.2. Analytical methods ......................................................................................... 36
5.2.1. Analytical methods supported ................................................................ 37
5.2.2. One-point Endpoint Method ................................................................... 38
5.2.3. Two-point Endpoint Method ................................................................... 39
5.2.4. Two-point Kinetics ................................................................................... 40
5.2.5. Kinetics A ................................................................................................. 41
5.3. Calibration method ......................................................................................... 42
5.3.1. One-point linearity method (K-factor method)....................................... 42
5.3.2. Two-point Linearity Method.................................................................... 43
5.3.3. Multi-point linear method ....................................................................... 44
5.3.4. Logit-Log 4PNon-linear Method ...................................................... 45
5.3.5. Logit-Log 5PNonlinear method ....................................................... 46
5.3.6. Index method (non-linear method)......................................................... 47
5.3.7. Polynomial method (non-linear method ............................................. 48
5.3.8. Parabola method (non-linear method) ................................................... 49
5.3.9. Spline method (non-linear method)........................................................ 50
5.4. Calibration type .............................................................................................. 51
5.5. The Checking of test status............................................................................. 51
5.5.1. Verification of calibration ........................................................................ 51
5.5.2. The checking of absorbance limit ............................................................ 52
5.5.3. The linear checking to reaction ............................................................... 52
6. The operation of the software ..................................................................................... 54
6.1. The structure of the user interface ................................................................ 54
6.2. How to operate interface elements ............................................................... 55
6.3. Menu system .................................................................................................. 57
7. Detailed Operation ....................................................................................................... 58
7.1. Daily operational process ............................................................................... 58
7.2. Preparations before analysis .......................................................................... 59
7.2.1. Checking the system before start ............................................................ 59
7.2.2. Starting up ............................................................................................... 59
7.2.3. Starting control software of analyzer ...................................................... 59
7.2.4. Confirm the status of instrument ............................................................ 60
7.2.5. Confirming analytical conditions ............................................................. 61
7.3. Setting analysis items ..................................................................................... 61
7.4. Setting up profiles........................................................................................... 61
7.5. Setting up Calculated parameters .................................................................. 61
7.6. Setting up cross contamination definitions .................................................... 62
7.7. The preparation of reagent ............................................................................ 62
7.8. Requesting tests ............................................................................................. 62
7.9. Functions available during the testing process .............................................. 62
7.9.1. System monitoring .................................................................................. 62
7.9.2. Suspending and resuming operation....................................................... 62
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7.9.3. Emergency STOP ...................................................................................... 62

7.9.4. Adding further samples ........................................................................... 62
7.10. Confirmation of test results............................................................................ 62
7.11. Finishing the analytical process ...................................................................... 63
7.11.1. Exit the control software .................................................................. 63
7.11.2. Power off .......................................................................................... 63
7.11.3. Your tasks after power off ................................................................ 63
8. Sample testing .............................................................................................................. 64
8.1. Registering samples for testing ...................................................................... 64
8.2. Test Result ....................................................................................................... 66
8.2.1. View the results ....................................................................................... 66
8.2.2. Delete a result ......................................................................................... 66
8.2.3. Print a report ........................................................................................... 66
8.2.4. Viewing the reaction curve...................................................................... 67
8.2.5. Retesting samples .................................................................................... 67
8.3. Query Results.................................................................................................. 69
8.3.1. Query by sample...................................................................................... 69
8.3.2. Query by item .......................................................................................... 70
9. Calibration .................................................................................................................... 71
9.1. Calibration register ......................................................................................... 71
9.2. Calibration Result ........................................................................................... 72
9.2.1. The editing of calibration results ............................................................. 72
9.2.2. View the calibration curve ....................................................................... 73
9.2.3. View the reaction curve .......................................................................... 74
10. Quality control ....................................................................................................... 75
10.1. QC register ...................................................................................................... 76
10.2. QC result ......................................................................................................... 77
10.3. Within day QC ................................................................................................. 79
10.4. Daily QC .......................................................................................................... 80
11. Reagent information .............................................................................................. 81
11.1. Precautions about using reagents .................................................................. 81
11.2. Registration of reagents ................................................................................. 81
11.3. Reagent scan................................................................................................... 82
12. Settings .................................................................................................................. 83
12.1. Application setup ............................................................................................ 83
12.1.1. Test item parameters ........................................................................ 83
12.1.2. Reference range................................................................................ 86
12.1.3. Other settings ................................................................................... 87
12.2. Profile setup ................................................................................................... 88
12.2.1. Test items .......................................................................................... 88
12.2.2. Calculated item ................................................................................. 89
12.2.3. Manual Item ..................................................................................... 90
12.3. Contamination settings .................................................................................. 91
12.4. Print setup ...................................................................................................... 92
12.4.1. Basic information setup .................................................................... 92
12.4.2. Item order setup ............................................................................... 92
12.4.3. Report format setup ......................................................................... 92
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12.5. User settings ................................................................................................... 93

13. Miscellaneous items .............................................................................................. 94
13.1. Data management .......................................................................................... 94
13.1.1. Data dictionary ................................................................................. 94
13.1.2. Data maintenance ............................................................................ 95
13.1.3. Data statistics.................................................................................... 96
13.2. System log....................................................................................................... 97
14. Maintenance menu ............................................................................................... 98
14.1.1. Serial port setup ............................................................................... 98
14.2. Service menu .................................................................................................. 99
14.2.1. Action debug .................................................................................... 99
14.2.2. Instrument parameter .................................................................... 100
14.1. Cuvette cleaning ........................................................................................... 101
15. System monitoring .............................................................................................. 102
15.1. Sample disk status ........................................................................................ 102
15.2. Reagent disk status ....................................................................................... 103
15.3. Reaction disk status ...................................................................................... 104
16. Alarm of instrument and solutions...................................................................... 105
16.1. Confirmation of alarm information .............................................................. 105
16.2. Type of alarm information ............................................................................ 105
16.3. Content of alarm information and solutions ................................................ 107
17. Instrument Maintenance..................................................................................... 115
17.1. Preparation for the maintenance ................................................................. 116
17.2. Daily Maintenance ........................................................................................ 116
17.2.1. Checking the Distilled water tank ................................................... 116
17.2.2. Checking the Waste liquid tank ...................................................... 117
17.2.3. Checking the Probe......................................................................... 117
17.2.4. Checking the Mixing Probe ............................................................. 118
17.2.5. Checking the Washing system ........................................................ 118
17.3. Weekly Maintenance .................................................................................... 119
17.3.1. Cleaning the sample probe............................................................. 119
17.3.2. Cleaning the mixing probe.............................................................. 119
17.3.3. Cleaning the sample probe............................................................. 120
17.3.4. Checking the injecting probe .......................................................... 120
17.3.5. Cleaning the reagent / sample compartment ................................ 121
17.3.6. Cleaning the waste liquid tank ....................................................... 121
17.3.7. Cleaning the distilled water tank compartment............................. 122
17.3.8. Cleaning the panel of the analyzer ................................................. 122
17.4. Monthly Maintenance. ................................................................................. 123
17.4.1. Cleaning the wash well of the Probe .............................................. 123
17.4.2. Cleaning the wash well of the mixing probe .................................. 123
17.5. Maintenance every six months .................................................................... 124
17.6. Irregular Maintenance .................................................................................. 124
17.6.1. Cleaning the Sample Probe ............................................................ 124
17.6.2. Mixing probe replacement ............................................................. 129
17.6.3. Replacing the lamp ......................................................................... 131
18. Appendix A System specifications ....................................................................... 136
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18.1. Analyzer performance .................................................................................. 136

18.2. Sampling system ........................................................................................... 136
18.3. Reagent system............................................................................................. 136
18.4. Reaction system............................................................................................ 137
18.5. Optical system .............................................................................................. 137
18.6. Calibration and Quality control .................................................................... 137
18.7. Operating system.......................................................................................... 138
18.8. Working Environment ................................................................................... 138
19. Appendix B........................................................................................................... 139
19.1. Accessories/Consumables ............................................................................ 139
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1. Introduction
Thank you for purchasing the normachem 2OO Automated Clinical Chemistry Analyzer.
This operators manual contains important safety and application instructions.
Please read this manual thoroughly and understand it for relevant operation instructions
before using the instrument. Please keep this manual at hand for reference.
Product Information:
Product name: Automated Biochemistry Analyzer
Model: normachem 200
Who should read this manual?

This manual is written for the following clinical laboratory professionals:
- operators using the analyzer on a daily basis
- operators performing system maintenance and troubleshooting
Disclaimer
The manufacturer reserves the right to:
- modify the contents of this manual without prior notice.
- change technology applied within the analyzer without prior notice.
- change technical specification without prior notice.
The manufacturer does not warrant this manual to be 100% free of unintentional errors.
Note:
This Manual may be revised without prior notification.
The Manufacturer reserves the right to change the
specifications of the product and/or the contents of this manual
as deemed necessary, without prior notice.
Pictures included in this manual may differ from the actually delivered product.
Performance and reliability are never influenced by minor visual differences to the
manual.
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1.1. Symbols and labels used in this manual

Below is the list of signs and labels used in this manual to ensure personnel safety and
proper testing function of the analyzer.
The safety symbols below will be used together with explanatory descriptions.
Symbol Meaning
WARNING
Remind the user to operate according to user manual, to avoid
system damage or personal injury.
BIOHAZARD
Remind the user to operate according to user manual, to avoid
biological pollution hazard
1.1.1. Symbols used on the Label on the analyzer
Symbol Meaning
CE mark
for In Vitro Diagnostic use
Biological pollution hazard
Electrical hazard
Date of manufacture
Anti-electric shock standard: Class B
Serial number
Warning: High Temperature
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1.1.2. Pictures used in this manual
The pictures used in this manual are only used for illustration purposes
1.1.3. Safety Symbols
WARNING
Failure to follow instructions in this manual may lead to instrument damage
or unreliable test results
1.2. Safety measures

In order to avoid electric shock caused by improper operation, please make sure to follow
the instructions described below
WARNING
When the MAIN POWER or Reagent Cooling Area power is on, users are not
allowed to open the rear cover or tear down this instrument if you are not
the authorized person by this company, once there is liquid access to inner
system or there is a leakage on system, please switch off the power
immediately, and contact with Norma Customer Service Department or your
local distributor. Improper operation may lead to an electric shock risk and
may cause system damage.
1.2.1. To prevent personal injury
To avoid personal injuries caused by moving parts, please strictly comply with the
following note:
WARNING
When the system is operating, dont touch the moving parts of the system,
the moving parts including the sample probe, the mixing probe and washing
station parts. It is strictly prohibited to reach into the analyzer during
operation.
1.2.2. Protection against biohazard
In order to protect the biochemistry dangerous effectively, please comply with the
following attentions:
BIOHAZARD MATERIAL
Inappropriate handling of samples may lead to pollution. Avoid contact with
sample, reagents and waste. Wearing gloves and lab coat and safety goggles
during operating the analyzer is strongly recommended.
If the sample came in contact with your skin, please deal with it
immediately follows users working standard.
Some reagents are of strong acidic or strong basic effect. Please pay
attention when using reagents, avoid direct contact with your hand or
clothes. Once your hand or cloth unintentionally contacted with reagent,
please immediately flush it with soap and water. Would reagent get into
your eyes, please flush your eyes with a large quantity of water immediately,
and consult a doctor.
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1.2.3. Waste liquid treatment:
In order to prevent the environmental pollution and personal injury caused by waste,
please comply with the following instructions:
BIOHAZARD MATERIAL
As some substances in reagent, calibration solution, cleaning liquid and
waste are controlled by pollution regulations and emission standards. Please
comply with your local pollution standards, and consult the manufacturer or
distributor of the reagents for information.
CAUTION
In order to use this instrument correctly and effectively, please read the
following cautions carefully.
1.2.4. System function
WARNING
This instrument is primarily used for quantitative analysis of samples of
serum, plasma, urine, cerebrospinal fluid, etc. If your intended use of this
instrument exceeds this range, please consult Norma for instructions.
When making clinical decisions based on analysis results, please also refer
to other clinical symptoms or other test results.
1.3. Operating environment

WARNING
Please install the instrument in an installation environment complying with
the description within this manual.
If you operate the system in an environment different from the above
specified, it may lead to unreliable results and even damage to equipment.
To relocate the system, please contact Norma Customer Service Department
or your local distributor.
1.3.1. Preventing Interference by Electromagnetic Noise
WARNING
Electromagnetic noise may interfere with system operation. Do not install
devices generating excessive electromagnetic noise around the system. Do
not use devices such as mobile phones or radio transmitters in the same
room where this analyzer is installed.
Avoid using CRT displays around the system
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1.3.2. System operation
WARNING
1Operate the system strictly as described in this manual. Inappropriate use
of the system may lead to unreliable test results, equipment damage or
personal injury.
2Before using the system for the first time, run the QC program to make
sure the analyzer is in proper state.
3Do not open the cover of the sample/reagent disk while the system is
operating.
4The RS-232 port on the analyzing unit is to be used for connection with
the operation unit only. Do not use it for other connections. Only use the
supplied cable for the connection.
5The operation unit is a personal computer with the operating software
installed. Installing other software or hardware on this computer may
interfere with the system operation. Do not run other software while the
system is working. Do not use this computer for other purposes or
connection to the Internet. Otherwise viruses may infect your system and
spread into the system through uncontrolled media, software or network.
6Do not touch the display, mouse or keyboard with wet hands or
chemicals.
7When powering OFF the system by the MAINS switch, please allow 10
seconds before turning it back ON again for the power system to reset.
Turning the switch back ON immediately, may cause the system to engage
power protection functions. If it does so, place the MAIN POWER to OFF and
place it to ON again after 10 seconds.
1.4. System maintenance

Please make sure to perform a regular maintenance of the system as follows.
Inappropriate maintenance may affect operation or the performance of instrument.
WARNING
1Maintain the system as described in Chapter 7 - System maintenance of
this manual. Inappropriate maintenance may lead to unreliable results,
could affect the performance and instrument lifetime, it could even lead to
system damage or personal injury.
2If the system has been in use for a long term, the surface may be covered
by dust. To wipe off dust from the system surface, use a clean, soft and
damp non-scratching cloth, soaked with soapy water if necessary. Do not
use organic solvents such as ethanol for cleaning. After cleaning, wipe the
surface dry with a dry cloth. Switch off the power and disconnect the power
plug before cleaning. Take necessary measures to prevent water ingression
into the system, otherwise it may lead to equipment damage or personal
injury.
3After replacing major parts, such as the lamp, sample probe or mixing
probe assembly, you must do a QC analysis.
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1.5. Sample handling

WARNING
1) Please use the serum sample of completely separated .If the serum
sample contains fibrin it may block the sample probe and can affect analysis
results. Medicines, anticoagulants or preservative in the samples may lead
to unreliable results.
Hemolysis, jaundice or chylomicron in the samples may lead to unreliable
test results, so sample blanks are recommended.
2Store samples properly. Improper storage may change the composition of
samples and may lead to unreliable results.
3Sample volatilization may lead to unreliable results. Do not leave the
sample open for a long period.
4Not all the tests the reagents claim capable of analyzing can be analyzed
on the system. Consult the reagent suppliers for details.
5Certain samples need to be processed before being analyzed by the
system. Consult the reagent suppliers for details.
6The system has a specific requirement on the sample volume. Refer to
this manual for proper sample volume.
7Load the sample to proper tube position on the sample disk before the
analysis begins; otherwise you will not obtain correct results.
1.6. Reagent, calibration solution and blank solution

WARNING
1Use proper reagents, calibration solution and blank solution when
analyzing.
2Select appropriate reagents according to performance characteristics of
the system. Consult the reagent suppliers, Norma or authorized distributors
for details, if you are not sure about your reagent choice.
3Please comply with operating instructions for storing and using of
reagent, calibration solution and blank solution.
If you store the reagent, calibration solution and blank solution in an
improper way, even they are in period of validity; it may also lead to not
obtain reliable results or best performance of the system.
4Perform calibration after changing the reagents. Otherwise, you may not
obtain reliable results.
5The cross contamination to reagents may affect test results. Consult the
reagent suppliers for details.
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1.7. Parameter setting

WARNING
Before testing, you must set the sample volume, reagent volume and
wavelength. When setting these parameters, please comply with the
relevant instructions of this manual, and reference the reagent instruction.
1.8. Data backup

WARNING
The system automatically stores the data to the built-in hard disk. However,
data loss is still possible due to accidental deletion or physical damage of
the hard disk. Norma recommends you to regularly back up the data to
media such as CDs.
1.9. Manufacturers Statement

- Norma reserves the right to modify the content of this manual without notice.
- Norma has the right to improve technology without notice.
- Norma has the right to change the specification of product without notice.
- Norma does not guarantee this material in any form, including the implied
guarantee for the merchantability and fitness.
Norma will be responsible for machine's security, reliability and function if and only if the
below described conditions are met:
- The assembly manipulation, extension, re-debugging, improvement and

requirement work are all done by Norma authorized staff;
- Relative electrical device meet the requirement of national standard
- The instrument has been operated in accordance with this manual
Norma cannot be held responsible for the safety, reliability and operation of the product if
any of the below conditions are proven to have been met:
- Subassembly is disassembled, stretched, or re-debugged by non-Norma-staff;

- The equipment is repaired, changed, or disassembled by someone without the
authorizing of Norma;
- The damage in the instrument is caused by incorrect operation or neglect.
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1.10. Repair service

The equipment can enjoy free service if it is in the prescribed scope of company's
warranty service regulations.
Charging service range
1 The company will charge for the service if it is out of the prescribed
scope of company's warranty service regulations.
2 Even though the equipment is in the warranty period, company will
charge in following situation: man-made damage; improper using;
irresistible nature disaster; the voltage of electric deficiency is out of
regulated scope; change accessories and consumptive material
without permission of Norma or the equipment is repaired by
non-authorized staff.
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2. System Construction
normachem 200 consists of

- analytical unit,
- computer operating the analytical unit,
- output device (printer),
- spare parts and consumables.
2.1. Analytical unit

The analytical unit consists of:
- Sample/Reagent tray,
- Dispensing mechanism,
- Mixing mechanism,
- Reaction tray,
- Optical System and
- washing system
Picture 2.1 instrument general view
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2.1.1. Sample/reagent tray
The sample/reagent tray is used to hold reagents and samples.

It is composed of three circles:
- inner circle,
- middle circle and
- outer circle,
The inner and middle circles are used to hold one or two-component reagents providing
all together 44 reagent positions.
The outer circle is able to hold up to 44 sample vials.
The sample positions accept the following sample tubes:

- Micro sample cup and centrifugal tube
- Blood collection tube 1268.5129912.77512.7100
- Plastic tubes
Reagent positions can only hold original Norma bottles. There are two types of reagent
bottles with volumes of 40ml and 25ml.
The sample/reagent tray is located in the sample/reagent compartment. This

compartment can maintain a steady temperature between 4-15C.
WARNING
Make sure to that the reagent tray is covered otherwise it may reduce the
refrigeration capacity of the cooling system, and may also damage the
sample probe. Before starting analysis, make sure that the cover is closed to
avoid damaged to the probe.
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WARNING
The reagent cooling system is independent form the analytical unit. This
means that the cooling function can remain operating even with the
analytical system powered off.
Please dont use sample tube and reagent bottle out of specification
2.1.2. Dispensing mechanism
The dispensing mechanism is composed of:

- sample/reagent probe,
- arm, and shaft,
The dispensing system is used to aspirate specified volumes of sample and reagent from
sample tubes or reagent bottles and then dispensing these volumes to a reaction cuvette.
After dispensing the sample or reagent, the dispensing mechanism moves to the washing
well position, to wash the inner and outer walls of the sample probe.
Arm
shaft
Sample
Probe
Washing well
Picture 2.1.2 dispensing mechanism
Sample volume 3-30l, with 1l increase

Reagent volume 150-300l, with 1l increase
The dispensing mechanism is composed of:

- a built-in preheating element,
- detector system for sample/reagent liquid level
- collision-detection system for the vertical direction.
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WARNING
When the analyzing unit is in operation, do not place any part of your body
or any obstacle in the route the arm moves. Otherwise, it may lead to
personnel injury or equipment damage.
2.1.3. Mixing mechanism
The mixing mechanism is composed of:

- mixing probe,
- mixer arm and driving shaft.
The mixing arm is used to homogenize liquid (reagent and sample) in cuvettes.
Arm
Driving
Mixing
shaft
probe
Washing well
Picture 2.1.3 mixing mechanism
When testing a single reagent item, the mixing mechanism will mix the sample-reagent
solution immediately after the solution has been dispensed into the cuvette.
When testing a two-reagent item, it will mix only after the second reagent has also been
dispensed into the reaction cuvette.
When mixing is finished, the mixing mechanism will move the stirrer to the washing well
to clean the outer wall of the mixing probe.
2.1.4. Reaction tray
The reaction tray is used to hold reaction cuvettes for the colorimetric readings.
Picture 2.1.4 Reaction tray

The reaction tray contains 48 cuvettes, made of 6 cuvette segments, 8 cuvettes each.
During the analytical process, the cuvette to hold the specific sample-reagent mixture will
19
stop on the dispensing position to receive sample and/or reagent. The mixer will
homogenize the solution. The colorimetric readings are made when the specified cuvette
passes through the optical axis.
The cuvette is: 5mm6mm25mm, the optical path is 6mm. The volume of the cuvette is
750l, ideal reaction volume is 150-300l. Cuvettes can be reused. When a cuvette is
detected to be out of specified transparency, the single cuvette or the cuvette segment
can be replaced.
The reaction tray is located in a temperature-controlled chamber, keeping a constant

temperature at 370.1.
CAUTION
Turn off the power of system when changing cuvette, and turn it to the
required position by hand. Then disassemble the old cuvette and find the
position in cup, then push it and put the new one on it. Please avoid scuffing
the new cuvette, and avoid scratching the transparent surface.
2.1.5. Optical unit
The optical unit is the core component of this testing system, used to measure the
absorbance of the reaction mixture in the cuvette. This Analyzer adopts Back-Dividing
light technology and provides 10 wavelengths: 340nm, 405nm, 450nm, 492nm, 505nm,
546nm, 578nm, 620nm, 670nm, 700nm and 1 reserved position.
The light source is a Halogen lamp 6V/10W, the life span is 3000 hours or above.
CAUTION
When the A/D values for all wavelengths decrease and influence test
performance, you need to consider changing the light source. When
replacing the lamp, you need to turn off the power, the system at least need
to cool for 20 minutes before replacing, otherwise, the hot surface of light
source can easily lead to burn.
2.1.6. Washing unit
The washing unit is composed of sample/reagent probe and cuvette washing systems.
Sample/reagent probe washing happens after adding sample of an item into the cuvette,
the sample/reagent probe will return to the washing well position. The washing motor
and the valve of clean pipe will open, to wash operation to both the inner and outer walls
of the probe. The same washing action is performed whenever the probe dispensed any
liquid into any cuvette.
Cuvette washing
The washing of cuvettes is performed by a washing probe (composed of an injection
needle and an aspiration needle, driving shaft, stepping motor and tubes). Each cuvette,
when positioned below a washing tip will first be emptied by vacuum, and cleaning liquid
20
is injected into the cuvette. The cuvette then moves on to the next washing tip. The next
step (tip) will empty the previously added cleaning solution from the cuvette prior to
adding the next cleaning liquid.
The cleaning system is an 8-step washing process.

- tip 1 (rightmost) cleans the cuvette with cleaning solution
- tips 2-6 clean the cuvette using distilled water
- tip 7 aspirates any remaining distilled water from the cuvette
- tip 8 dries the cuvette with a special, tight-fitting plastic element
2.2. Operation unit

The operation unit is a computer running special controlling software responsible for user
interface, database management and report printing.
2.3. Output unit

The output unit (optional) is a printer connected to the operating computer. The software
offers three printout formats, printout header contents can be specified by the user.
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3. System installation
3.1. Hardware installation

WARNING
NORMACHEM 200 should be installed by NORMA authorized staff only.
3.2. Unpacking
Before installing, please carefully check your delivery for shipping damage. If you see any
signs of mishandling or damage, file a claim immediately with Norma Customer Service
Department or your local distributor.
After opening the package, check the delivered goods against the packing list as well as
the appearance of the system. If you find anything missing or damaged, contact Norma
Customer Service Department or your local distributor immediately.
3.2.1. The contents of the package
Analyzer
Accessories
Item Part No. Description Quantity
(pcs)
1 Normachem 200 Clinical Chemistry Analyzer 1
2 30ml reagent bottles 22
3 20ml reagent bottles 22
4 Power cord 1
5 Serial link cable 1
6 CD / USB stick with SW install set 1
7 Liquid container caps with level sensors 1 set
8 Protective earth wire 1
9 Sample vials 50
10 Cuvette segments 6
11 Cuvettes 48
12 Bottle (DI water 20L) 1
13 Bottle (WASTE 20L) 1
14 Bottle (for cleaner solution 5L) 1
15 Operators manual 1
16 Cleaning solution (1L) 1
22
3.3. Installation requirements

3.3.1. Installation environment
- normachem 200 is designed for indoor operation

- The bearing platform should be level (the gradient should be less than1/200)
- The bearing platform should be able to bear the weight of 100 kg at least
- Sufficient ventilation
- The environment should be dust-free as much as possible
- Avoid direct sunlight
- Avoid installing the instrument near heat or wind sources
- Avoid applying corrosive and flammable gases nearby
- The bearing platform should be free of vibrations
- Avoid installing the instrument near electrical noise sources (x-ray devices,
centrifuges, radio transmitters)
- Keep away from brush-type motor and electric contact equipment which needs to
be powered on and off frequently
- Keep away from equipment generating strong electromagnetic fields, such as
mobile phone or radio transceiver
- The altitude above sea level of the working place should be less than 2000 meters.
3.3.2. Power requirements
- Power supply: alternating current 198V-242V, 50/601Hz, grounded

- The system needs a grounded power outlet to provide required power safety
- The length of the power cord should be less than 3 meters
- The power outlet should be protected by a 10A fuse.
WARNING
Connect the power with ground correctly. Improper grounding may lead to
an electric shock or system damage. Please check that the output voltage of
the power outlet meets system requirements and has a proper fuse
installed (6A/220V 520).
3.3.3. Requirement for humidity and temperature
- The storage temperature of this system is 0-40, fluctuation <2C/hour

- The storage humidity of this system is 30%RH-80%RH, non-condensing.
WARNING
If the system is not used for a long time, aging rate for the machinery and
electric circuit inside may speed up. Even if the analyzer is not used for a
longer period of time, please run the equipment at least for once every 2
months.
The humidity and temperature for working
23
- The working temperature of this system is 1530fluctuation <2/H

- The working humidity of this system is 30%RH80%RHwith no condensation.
WARNING
Operate the system within the regular range of environment, humidity and
temperature, or the result will be unreliable. If the temperature or relative
humidity exceed above range, use of air-conditioning equipment is
recommended.
3.3.4. Requirement for water supplying and draining
- The temperature of water supply is 5~50.

- Water used must be de-ionized water, conductivity must be below 2S
WARNING
Water used must be de-ionized water, conductivity must be below 2S
24
3.3.5. Space requirements
The installation and using of the system should fulfill space requirements shown below.
Min:500
RS-232 Connection
RS-232 RS-232
Computer
Analyzer Min:500
frontage
Min:500
Min:500
Unitmm
Picture 3.1.2.5 Installation diagram
25
3.3.6. Connection of accessories and serial port
BIOLOGICAL POLLUTION HAZARD

When emptying the waste liquid, please be sure to wear work clothes and
gloves to prevent infection. If necessary, please wear safety goggles.
ATTENTION
When installing the waste liquid container, the top opening of the container
must not be higher than waste liquid outlet in the back of the analytical unit
to allow the liquid flow out smoothly.
Make sure that there are no bending, twisting and insecure connections in
waste liquid pipe/distilled water pipe/washing solution pipe/ pipe of water
refrigeration cycle. Otherwise the instrument cannot work normally due to
abnormal circulating of liquids inside and water may leak which could
damage the system.
(See image on next page)
1. Make sure the power of the analytical unit is off.
2. Connect the thin tube marked with a blue tape to the nozzle on the DI water
bottle caps nozzle. Push the thick tube marked with a blue tape through the
opening on the DI water bottle cap, making sure that the end of the tube reaches
the bottom of the bottle.
3. The system uses two waste tubes. Connect the thin tube marked with a red tape
through the small hole on the waste bottle cap. Connect the thick tube marked
with a red tape through the big hole on the waste bottle cap.
4. Connect the washing solution soft tube (marked with white tape) to the washing
solution container.
5. Insert the sensor of washing solution into the washing solution bucket through the
round hole.
6. Aiming the sensors plug to sensor port joint on the back of analyzer, push
forward slightly, and fasten the connector by twisting it on.
7. Separately connect the serial port line to the port of computer and the back of
instrument labeled RS-232 (see below picture). Secure the two sides of the
connector with the screws.
26
Picture 3.1.3 The connection chart on the back of analyzer
3.3.7. Installation and removal of the sample/reagent tray
ATTENTION
Before installing or removing reagent/sample tray, please confirm that the
tray stopped moving. The best way is to turn off the analyzer prior to
installation / removal of the tray.

Always wear gloves and protective goggles when installing or removing
reagent/sample tray.
Please note that the tray must be installed or removed vertically, toppling
from the side is prohibited, because this way, samples/reagent can flow out.
27
Picture 3.1.4 sample/reagent tray chart
When loading the tray, it should be in horizontal situation, aiming the pole of hand wheel
on the tray towards the aluminum hole on the drive axle, meanwhile aiming the
positioning hole of sample tray towards the positioning pin on the principal axis.
Then turn the knob clockwise to lock the tray on the drive axle.
When removing the tray, turn the knob anti-clockwise, and then lift the knob to release
the tray. Now you can take out the tray upwards.
CAUTION
The sample/reagent compartment and the tray may be polluted during
operation, when materials splash or accidentally overflow in the
compartment. It is recommended to power off the analyzer before cleaning
the compartment.
To clean, wipe the compartment clean using a cleaning cloth dampened
with disinfectant. Cleaning should be performed regularly.
Before running the system, please check whether the tray is securely
installed, reagent container caps have been removed, and all reagent
contained are securely seated in their triangular individual compartments.
Not doing so can damage the sampling tip.
3.3.8. Loading and removal of sample cup/sample tube

When loading or removing sample test tubes, sample cups, please wear
gloves prevent infection.
28
ATTENTION
Before loading or removing sample tubes, please make sure the
samples/reagent tray and sample probe have stopped moving.
Dont use sample tubes/cups out of specification.
To load sample tubes, please insert the tube into test tube clip so that the bottom of
sample tube touches the bottom of the trays rubber seating elements.
To remove sample tubes, pull the sample tube upward by hand.
3.3.9. Loading and removal of reagent containers

When loading or removing reagent containers, please wear gloves prevent
infection.
ATTENTION
Before loading or removing reagent containers, please make sure the
samples/reagent tray and sample probe have stopped moving.
Dont use sample tubes/cups out of specification.
To load reagent bottles, insert the reagent bottle containing reagent into the reagent
bottle slot, until the bottom of reagent bottle touches the bottom of the bottle slot.
To remove reagent bottles, pull reagent bottle upward.
29
3.3.10. Replacing cuvettes

When loading or removing cuvettes, please wear gloves prevent infection.
ATTENTION
When replacing the cuvettes/cuvette segment, please make sure the system
is powered off.
When replacing cuvettes first make sure that the system is powered off or has stopped
movement. Then turn the reaction tray to a comfortable position by hand. Remove the 2
screws fixing the segment holding the cuvette to be replaced and take the whole segment
out from the reaction tray.
When you found the cuvette to be replaced, then press the bottom of cuvette upwards
through the cuvette segment to take it out it. To replace, push in the new cuvette. Avoid
touching the sides of the cuvette that are in the path of light.
knob screw
colorimetric cup groups
Picture 3.1.7 Reaction tray
30
4. Software installation
4.1. Minimum requirements for computer hardware

- Processor: Intel Pentium IV 1.6Ghz above
- memory: DDR2 512M above
- hard drive: 80G or above
- CD-ROM: 52X or above
- display 15 inches above, resolution: 1366x768
- Keyboard standard 101 keyboard
- Mouse: standard
- Communication port: at least one RS-232 interface
- Operating system Windows 7
- Printer: Windows compatible printer
4.2. Software installation

Insert the SW CD into the computers CD ROM drive. Find the file NORMACHEM 200 on
the CD. Double click the SW icon to run. Follow instructions on the screen.
n
NC200Setup.msi
Double click the above icon with the left mouse key. The control software for
NORMACHEM 200 will be automatically installed. Follow instructions on the screen.
31
32
When prompted, allow access to your computer system in Administrator mode for
successful installation.
33
After the progress bar reaches the end, you will see the following screen:
Click Close.
There will be a shortcut icon created on the desktop, as shown below:
n
normachem 200
Double-click the icon to start the control interface of the software. You will have to
confirm running in administrator mode each time you start the software.
34
5. Operating Principle of the instrument
5.1. Mechanical operating principle
After starting the analytical system, the analyzer will first reset, the reagent tray and the
reaction tray will turn to the first (#1) position, the sample probe and mixing probe will
stop above their washing wells, and washing needles will stay at the top position.
The washing system starts the washing from the cuvette #1, then after 2 full circles, it
stops and starts to wash the cuvette #2. It keeps repeating the same procedure, until it
washes the cuvette #17. It takes about 12 seconds for the reaction tray to make two full
circles. During the washing procedure, the cuvettes pass through the photometer, so at
the same time, the blank value of the cuvettes is also acquired. This blank value is then
used as the reference value for the future tests.
When the washing system starts to wash the cuvette #18, the sample probe will start
adding sample and reagent R1 to cuvette #1. When the sample probe leaves cuvette #1,
the mixing probe starts mixing the reaction liquid in cuvette #1. When the sample probe,
the mixing probe and washing system all leave the reaction tray, then the reaction tray
will start rotating. After 3 full circles, it will stop and repeat the above procedure. In each
circle, the instrument will collect the data of the reaction liquid for one time, and will treat
it as a photometry point. After the 11th photometry point, the analyzer will add reagent
R2, and repeats the above procedure until reaction is finished.
35
5.2. Analytical methods
Biochemistry Analyzer is based on the substances selective absorption for light, based on
the Lambert-Beer Law.
The detection principle is as follows:

- cuvettes containing sample solution (mixture of sample and reagents) is placed in
the path of a white light
- absorption on specific wavelengths is measured (absorption is proportional to the
concentration of the examined substance corresponding to the specific measured
parameter)and the distance the light travels through the sample solution (light
path)
That is:
1 I
A lg lg 0 b c
T It
where:
A the absorbance of light through the solution;
T light intensity of transmitted light compared to incident light,
(light transmittance) It /I0;
I0 light intensity of incident light;
It light intensity of transmitted light;
molar absorptivity of solution (ml mmol1 cm1);
c molar concentration of solution (mmol/ml);
b length of light path, or solution thickness (cm);
The light path is fixed and known. Solution molar absorptivityis the factor related to
the wavelength, solution and solution concentration. If the solution concentration is kept
stable under a certain wavelength, the solution concentration and the absorbance have a
linear correlation (reagent manufactures define directly).
When the sample to be tested is a homogenous solution, only its absorption influences
the light transmittance (assuming and ensuring that there is no fluorescence, dispersion
and photochemistry present).
Further assuming and ensuring that no material involved will make any interaction with
the light, and the absorbance of all materials involved are additive, then we can apply the
Lambert-Beer Law.
36
5.2.1. Analytical methods supported
Analytical Calculation formula of

Measuring Point Cuvette Gap
Methods Absorbance
One-point
L 0 B1 B2 AL AL 1
endpoint
1L49 2 2
method
Two-point
L M B1 B2 (AM AM 1) k(AL AL 1)
endpoint
1LM49 2 2
method
AM AM 1 AL AL 1
Two-point L M B1 B2
Kinetics 1LM49 2 2
2
t
L M
B1 B2
Kinetics A 1LM49 A(M L)
2
L+2M
L,M: measuring points

B: cuvette gap
(B1 B2) / 2 : the mean value for twice cuvette gap
Ax: the absorbance at measuring point X
A(M L) : the changing of absorbance each minute between measuring
points L and M
k: the correction factor of liquid volume
a
S Ri
k i 1
b
S Rj
j1
S: Sample volume
Ri,Rj: a is unrevised reagent volume, b is revised reagent volume.
Attention
Make sure to enter 0 for unused measuring points
During the measurement, the reaction liquid volume should be more than
or equal to 200ul, and less than or equal to 450ul.
When the system is operating, dont touch the moving parts of the system,
the moving parts including the sample probe, the mixing probe and washing
station parts.
It is strictly prohibited to reach into the analyzer during operation.
37
5.2.2. One-point Endpoint Method
The absorbance of the sample and reagent mixture is tested at a certain measuring point
to measure the sample concentration. The reaction curve is as shown below:
One-point Endpoint Method reaction curve

ameasuring point L-0(where 1L 49)
bThe calculation of absorbance:
Get the mean value of absorbance for measuring points L and L-1:
AL AL - 1
Ax
2
cCalculation formula for concentration:
Cx {K (Ax - B) C1} IFA IFB
CX sample concentration to be calculated
C1 No.1 calibration (reagent gap) concentration
K K factor,
B absorbance of reagent gap,
IFA, IFB: analyzer-dependent constantsstands for rake ratio and section
dAnalytical item: for example TP, ALB, etc.
38
5.2.3. Two-point Endpoint Method
The first measuring point is the point in time, when the reaction of the tested material has
not yet begun. The second measuring point is the point in time when the reaction has
ended or, when the reaction reaches a state of equilibrium.
The difference of the two absorbance values is used to calculate the sample concentration.
The reaction curve is shown below:
Two-point endpoint method reaction curve

ameasuring points L-M(where 1LM49)
bThe calculation of absorbance:
- One absorbance value is calculated as the mean value of absorbance at measuring

points L and L-1.
- Another absorbance value is calculated as the mean value of absorbance at
measuring points M and M-1.
- The difference of these two values will define the change of absorbance between
the two measuring points.
-
The calculation formula is the following:
(AM AM 1) k(AL AL 1)
Ax
2
and
a
S Ri
k i 1
b
S Rj
j1
a reagent quantity when testing AL

b reagent quantity when testing Am
cThe calculation for concentration
CX is waiting to be tested sample concentrationC1 is No.1 calibration(reagent gap)
concentrationK is K factor, B is absorbance of reagent gap, IFA and IFB are the constant of
the analyzer, stands for rake ratio and section.
39
dAnalytical item: for example enzymatic CREA etc.

5.2.4. Two-point Kinetics
There are two measurement points. These two points cannot be neither the initial
absorbance value, nor the final (end) absorbance value. The difference of the two
absorbance values is used for calculation. The reaction curve is shown below:
Two-point Kinetics Reaction Curve

ameasuring point:L-Mhere 1LM49
bThe calculation for absorbance
Take the mean value of the absorbance of the measuring points M and M-1. Subtract the
mean value of the absorbance of the measuring points L and L-1. Divide the difference
with the time elapsed between the two measurements.
AM AM 1 AL AL 1

Ax 2 2
t
Where
t: time interval(minute) between of photometry point L and M.
CX: sample concentration to be calculated.
C1: No.1 calibration (reagent gap) concentration
K: K factor,
B: absorbance of reagent gap (reagent blank),
IFA and IFB are analyzer dependent constants, stands for rake ratio and section
dAnalytical item: BUN, picric acid method CREA, etc.
40
5.2.5. Kinetics A
Concentration is calculated based on the change rate of absorbance values between two
measurement points. Reaction curve is as follows:
Kinetics A reaction curve

ameasuring point:L-Mhere 1LM49L+2M
bThe calculation for absorbance
Use the least square method to get the change rate of the absorbance for photometry
point L and M in unit minute.
Ax A(M L)
CX sample concentration to be calculated,
C1 No.1 calibration (reagent gap) concentration,
K K factor,
B absorbance of reagent gap,
IFA and IFB are analyzer dependent constants standing for rake ratio and section
dAnalytical item: ALT, AST, etc.
41
5.3. Calibration method

5.3.1. One-point linearity method (K-factor method)
This method will estimate the calibration curve through measuring the calibration solution
(reagent blank) absorbance. This value can be modified by a K factor.
One-point linearity calibration curve

aInput of "Calibration parameters"
Calibration types: One-point linearity method
Calibration point: 1 (calibration solution quantity)
bConfirm K factor:
Input K factor in the calibration results forms
cThe calculation for parameters:
B: The absorbance of calibration solution 1(reagent gap) or the change rate of
absorbance in a unit minute.
C1: Input the concentration of calibration solution 1(reagent gap)
K: Input value
dThe calculation for concentration:
Cx is the sample concentration under test,
Ax is the sample absorbance or the rate of change of absorbance over a minute,
IFA and IFB are analyzer dependent constants, rake ratio and section
eApplicable Analytical methods:

One-point End Point Method, Two-point End Point Method, Two-point Kinetics, Kinetics A
Method.
42
5.3.2. Two-point Linearity Method
Through the measurement of the calibration solution 1 (reagent gap) and solution 2 to get
the working curve, the calibration curves is as following:
Two-point Linearity Method calibration curve
aInput of "Calibration parameters"

Calibration types: Two-point linearity method
Calibration point: 2 (calibration solution quantity)
bThe calculation for parameters

B: The absorbance for calibration solution 1(reagent gap) or the change rate of
absorbance in a unit minute.
A2: The absorbance of calibration solution 2 or the change rate of absorbance in a unit
minute.
C1: Input the concentration of calibration solution 1(reagent gap)
C2: Input the concentration of calibration solution 2
C1 - C2
K: K
A2 - B
A2 - B
b: b B - ( ) C1
C2 - C1
cCalculation of concentration
Cx: concentration of the sample under test
Ax: absorbance of the sample or the change in absorbance over a minute
IFA and IFB are analyzer dependent constants, stands for slope and intercept.
dApplicable analytical methods:

One-point end-point method, two-point end-point method, two-point kinetics method,
Kinetics A Method.
43
5.3.3. Multi-point linear method
This method calculates the calibration curve by measuring calibration solutions of various
concentrations. This provides the linear working curve.
Multi-point linear calibration curve

a"Calibration parameters" inputting:
Calibration type: Multi-point linear method
Calibration point: 3-6 (the quantity of calibration solution.)
bParameters calculation
B the absorbance of calibration solution 1 (reagent blank) or the
absorbance changing rates per minute.
AN The absorbance of the calibration solution N or the absorbance
changing rates per minute.
C1 Input the concentration of calibration solution 1 (reagent blank).
CN Input the concentration of calibration solution N.
Kb be automatically calculated by linear regression.
Here Cx means Concentration of the being tested sample, Ax is the absorbance of the
sample or the change in absorbance per minute, IFA and IFB is the constant of instrument,
stand for the slope and intercept.
dAnalytical methods applied:.

one-point end-point method, two-point end-point method, two-point kinetics method,
Kinetics A method.
44
5.3.4. Logit-Log 4PNon-linear Method
Suit for reactions which absorbance appears a convergence trend comply with increased
concentration, the calibration curve as shown below
Logit-Log 4P Calibration curve

Calibration typeLogit-Log 4P
Calibration point4-6 the quantity of calibration solution.
B: the absorbance of calibration solution 1 (reagent blank) or the
An: The absorbance of the calibration solution N or the absorbance
C1: Input the concentration of calibration solution 1 (reagent blank).
CN: Input the concentration of calibration solution N.
K, a, b: approximate constant could be automatically calculated.
Cx (C C1) IFA IFB
K
Ax B
1 exp( a b ln C)
Here C is calculated by the quasi-Newton method.
Cx: Concentration of the sample under testing,
Ax: the absorbance of the sample or the change in absorbance per minute,
IFA and IFB are analyzer dependent constants, representing slope and intercept.
dApplicable analytical methods applied:

rate A method.
45
5.3.5. Logit-Log 5PNonlinear method
The method is similar to Logit-log4P with one additional parameter.
Logit-Log 5P calibration curve

Calibration type: [Logit-Log 5P]
Calibration points [5-6] (the number of calibration solution.)
Cx (C C1) IFA IFB
K
Ax B
1 exp( a b ln C c C)
C is calculated by the quasi-Newton method.
Cx: Concentration of the sample under testing,

Ax: absorbance of the sample or change in absorbance per minute
IFA and IFB are instrument dependent constants: slope and intercept.
dAnalytical methods applied:.

Kinetics A method.
46
5.3.6. Index method (non-linear method)
Suitable for reactions where absorbance appears as a disperse trend with increasing
concentration.
Index calibration curve

Calibration type [Index]
Calibration point [5-6] (the quantity of calibration solution.)
C1: Input the concentration of calibration solution 1 (reagent blank)..
Cx (C C1) IFA IFB
Ax B K exp{a lnC b (lnC) 2 c (lnC) 3 }
Cx: Concentration for the test sample,

Ax: the absorbance of the sample or change in absorbance per minute,
dApplicable analytical methods

Kenetics A method.
47
5.3.7. Polynomial method (non-linear method
Suitable for reactions where absorbance decreases with increased concentration.
Polynomial calibration curve

aInput "Calibration parameters"
Calibration typePolynomial
An: absorbance of the calibration solution N or the absorbance
Cx (C C1) IFA IFB
Ax a b C c C 2 d C3
Cx: concentration for the test sample

Ax: absorbance of the sample or change in absorbance per minute,

Kenetics A method.
48
5.3.8. Parabola method (non-linear method)
Suitable for reactions where absorbance appears as an increasing trend with increasing
concentration.
Calibration curve of parabola method

Calibration typeParabola
Cx (C C1) IFA IFB
Ax a b C c C 2

Kinetics A method.
49
5.3.9. Spline method (non-linear method)
Suit for reactions in which the absorbance will decrease comply with increased
concentration, the calibration curve as shown below
Picture 4.2.2.9 Calibration curve of spline method

Calibration typeSpline
bParameter calculations
a(I), b(I), c(I), d(I): approximate constant could be automatically calculated.
Cx (C C1) IFA IFB
Ax a(I) b(I) (C - C(I)) c(I) (C - C(I)) 2 d(I) (C - C(I))3

Kenetics A method.
50
5.4. Calibration type

We provide two different kind of calibration solution type according to different quantity
of calibration solution. The blank calibration which only calibrates the calibration solution
1 (reagent blank) and the all points calibration which calibrates with all setting calibration
solution. This allows choosing the required method.
Attention
When you input 1 on the quantity of calibration solution (K factor
method), you could only execute blank calibration
5.5. The Checking of test status

This instrument could execute a variety of inspections, aim at reaction status and testing
values, in order to improve the reliability of test data.
5.5.1. Verification of calibration
When performing calibration analysis, you can execute a variety of checks of calibration
items, such as the checking of blank level, the checking of discreteness, the checking of
sensitivity, the checking of drift rate.
1The checking of blank level

During the calibrating procedure, when the two times tested average value of the
calibration solution 1s absorbance exceeds the setting range of blank level checking,
there will be an alarm which alarms that the blank level checking of reagent has exceeded
(The alarm level is: Note).
For the alarming analysis item, the calibration reaction curve will be refreshed, the K value
will not be refreshed, you could select to not execute this item.
2The checking of discreteness
On calibrating procedure, each calibration solution (including reagent blank, which is
calibration solution 1) should be tested by two times, and take their average value. If the
difference of absorbance between two times tested is greater than the setting value of
the discreteness checking, there will be an alarm which alarms that value of discreteness
has exceeded (The alarm level is: Note).
For the alarming analysis item, it's calibration reaction curve will be renewed, the K value
will not be renewed, you could select to not execute this item.
3The checking of sensitivity
On calibrating procedure (Multi-point linear and non-linear),if the difference between the
absorbance of calibration reagent 1(the average value of absorbance tested by two times)
and the absorbance of the calibration solution with highest concentration(the average
value of absorbance tested by two times) is less than the setting value of the sensitivity
checking, there will be an alarm which alarms that value of sensitivity checking has
exceeded(The alarm level is: Note).
51
4The checking of drift rate

On calibrating procedure (Multi-point linear and non-linear),the difference between the
approximately calculated absorbance of each concentration and the absorbance gets from
test exceeds the setting value of the drift rate checking, there will be an alarm which
alarms that value of drift rate checking has exceeded(The alarm level is: Note).
5.5.2. The checking of absorbance limit
For items which use Kinetics A method or two-point kinetics method, when the
concentration exceeds the setting range, the instrument cant get the correct data. You
could set the upper limit value and lower limit value of absorbance, in order to check, and
gives an alarm message.
When there are four or above four tested absorbance dont fit the setting values of
absorbance, instrument will give an alarm. As shown below:
Absorbance limit
5.5.3. The linear checking to reaction
On the reaction of Kinetics A method, the change of absorbance should present a linear
relation with time. So we should make a checking to linear, once exceeds the limit, there
will be an alarm message.
1When the range of metering point is above 9N9
The principle for linear checking is to use the least square method, when N 9,we use the
difference of absorbance changing between the front 6 points and back 6 points to divide
the average of all absorbance variable, to proceed the linear checking. If the get value
exceeds the linear checking value, the instrument will give an alarm message.
A1 A2
100 > the input value for linear limit%
A
52
Linear checking N9
2When the range of metering point is 4 to 8 4N8
When 4 N 8, we use the difference of absorbance changing between the front 3 points
and back 3 points to divide the average of all absorbance variable, to proceed the linear
checking. If the get value exceeds the linear checking value, the instrument will give an
alarm message.
A1 A2
100 > the input value for linear limit%
A
Linear checking 4N8

When the metering points within reaction limit is within 3N3.
A 0.006 or A1 A2 0.006.
53
6. The operation of the software
6.1. The structure of the user interface

The user interface is composed of static and dynamic elements. The top row, the right side
and the bottom area of the screen are static. Function dependent screens are displayed in
the central area.
- Status Bar: displays the current state of system, including instrument status,
reaction temperature, active user and current time.
Possible instrument status values:
o online, offline, standby, testing, washing, self-test, and scanning
o temperature area shows the real-time temperature of reaction tank,
o user area shows operator name
- Primary key area: main functional buttons of software, you could click to enter
into relevant working area.
- Working area: users could enter into his choosing interface according to which
function this user chooses.
- Shortcut area: area for frequently-used functional buttons.
- Tips column: used to show if user action was successful, or an error occurred.
54
6.2. How to operate interface elements
Operation of textboxes
Click into textbox with the mouse, move the cursor to the textbox and input data.
Operation of a functional button

Click the functional button to access functions.
Operation of list-boxes and the scroll bar

If you want to choose multiple records within the list, there are two ways to do it:
- one is to click on the starting item, then press and hold the SHIFT key, and then
click the end record. All records between the start and end records are selected.
- the other way is to press and hold the Ctrl key, and then individually clicking on
records from a list. This will select the clicked records.
If the number of records is more than what can be displayed in the available area, a scroll
bar will be displayed. Click and drag the scroll bars central rectangle element to display
further records, rows.
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Operation of a drop-down list

Click the arrow on the right side of a drop-down list to open or close the list. By using the
drop-down list, more information can be displayed. Once you have choose an item, this
chosen item will be displayed in the list view, at the same time, the drop-down list will be
closed.
Operation of radio buttons and check boxes

Radio buttons: you can choose only one function from multiple functions.
Check boxes: You can simultaneously choose multiple elements.
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6.3. Menu system

Function key Sub pages Sub pages Function Page
Sample Test Sample register Add samples to process 64
Patient Info Add patient data 66
Test results Review sample results 71
Result Query Sample query Search for sample results 72
Item query Search for item results 76
Calibration Calibration register Add calibration samples 77

Calibration result Review calibration results 79
QC QC register Add QC samples 80

QC result Review QC results 81
Daily QC Review daily QC results
Monthly QC Review monthly QC
Reagents Add/edit reagents
Parameter Analysis item Analysis parameter Define method data

Reference ranges Ref. ranges for method
Other setup QC, calib., statistical data
Profile item Edit profiles, panels
Calculated item Define calculated item
Manual item Define manual item
Cross contamination Set cross contamination
Print setup Setup printed reports
Management User info Add/edit users

Data dictionary Frequently used data
Data maintenance Restore/backup
Data statistics Usage statistics
System log List of system messages
Maintenance Communication setup Change COM port

Instrument parameter Service Functions
Action debug Service Functions
Cuvette Photometer calibration
Help Open Operators manual
Start Start registered processes

Pause/resume Pause/Resume operation
Stop Emergency STOP
Sys.monitor Sample disc Check sample status
Reagent disc Check reagent status
Reaction disc Check cuvette status
Alarm info Review alarm messages
Online/Offline Connect/Disconnect
Logout Change user
Exit Exit Software
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7. Detailed Operation
This chapter introduces basic operational procedures of the system. After studying this
chapter, the user could fulfill daily operational processes.
7.1. Daily operational process
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7.2. Preparations before analysis
7.2.1. Checking the system before start
Before starting the instrument, please perform the following routine inspections, to
ensure normal operation.

When performing the following inspection, make sure to wear gloves to
avoid infection.
1. Check that power is OK (all cables securely connected).

2. Check that the serial cable is well connected with the computer.
3. Verify that level sensing cables of each external container is connected securely.
4. Check whether the waste liquid in the waste container is low enough.
5. Verify that the level of distilled water and washing solution are all OK.
6. Check the appearance state of the main components:
a. sample needle
b. mixing needle
c. washing unit
d. reagent / sample tray
e. reaction tray
7.2.2. Starting up
After you went through the above check and confirmed that everything is OK, turn on
power switches in the following order:
1. Analytical unit
2. Refrigerating system (if necessary)
3. Computer and display
4. Printer (if connected)
7.2.3. Starting control software of analyzer
1. After startup of the operating system, double-click the shortcut icon of control software
or choose the control software program from the [Start] menu. The following login screen
will be displayed:
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NOTE
The default user name is "admin", password is empty.
It is recommended to change it upon SW installation
Input user name and password, click Enter or press the Enter key on the keyboard, to
enter the software.
Clicking on Exit will cancel the Login procedure.
To exit the software, click the Quit button on the shortcut area.
Exiting is only possible if the system is in offline status. If the instrument is online, first
click Offline button, and then exit the system (Quit).
After a successful login, the analyzer status is offline meaning that the computer and
the analytical unit are not communicating. The status bar shows "offline". In offline
state, you can check functional areas of the form, you can log off and you can Exit from
the software.
Click Online. If there was no error, the status bar will show standby status. Now you can
execute all the operations, and test functions.
7.2.4. Confirm the status of instrument
Confirming alarm information

In the "Alarm information" form, check if there is any new alarm information. If you find
one, take necessary actions. We suggest you to confirm alarm information which you have
already dealt with in order to avoid too much information displayed in the list. Having a
huge list of messages will influence the effectiveness of information review. For detailed
instructions, please refer to the section of 15.1 Confirmation of alarm message
Confirming cuvette blank

In the Photometer calibration form, send a cleaning command (Wash). The instrument
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will clean the cuvettes and will perform cuvette blank measurement. If there are cuvettes
that do not meet inspection criteria, consider replacing those cuvettes. Refer to the
section of "13.4 Cuvette cleaning" for detailed instructions.
Warning
New cuvettes should be soaked in liquid for at least 8 hours before
installation. Then the cuvettes need to be repeatedly washed with tap water
and then rinsed with pure water. Only then can the cuvettes be installed.
Confirm the temperature of the reaction area

Observe the temperature display in the status bar of the main screen; check whether the
temperature in the reaction tank is 370.1. On the test procedure, if the temperature
exceeds range of 370.5, an alarm message will be displayed and the instrument will
continue the analysis. During standby, if the temperature of reaction tank exceeds 45,
the instrument will give a temperature level alarm.
7.2.5. Confirming analytical conditions
Before the test, you need to perform the below steps:

- add analysis items
- set analysis parameters,
- set calibration parameters,
- set QC parameters.
Regarding parameter settings and related information (instructions for use and storage
method for the reagent, calibration solution and QC solutions, please refer to the
instructions of the reagent manufacture or distributor).
7.3. Setting analysis items

In the "analysis item" form, you can add, modify and delete analysis items. Then you can
also execute the settings and confirm analysis parameters according to reagent
instructions. Some parameters are necessary for testing. For details, see section 11.1
Analysis item.
7.4. Setting up profiles

Profiles, or test item groups combine relevant measurement items (parameters) items
together. For example a liver profile contains the full set of parameters related to renal
function. Profiles speed up the measurement request process.
In the "profiles" form, you could choose which parameters to be included in a specific
profile.
7.5. Setting up Calculated parameters

A Calculated parameter is a means to provide a test result of an item using test results of
item various independent items. These calculations can be set in the "Calculated item"
form.
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7.6. Setting up cross contamination definitions

Cross contamination is a function which could reduce or avoid cross contamination
between analysis items.
7.7. The preparation of reagent

Input reagent information. Make sure you put reagent containers s to their designated
slots.
7.8. Requesting tests

There are there kinds of test tasks:
- sample test 7.1 sample registration,
- calibration test 8.1 calibration registration,
- QC test 9.1 QC registration.
When finished the application of test task, please click shortcut key START. The
instrument will start testing (measurement) of samples.
7.9. Functions available during the testing process
7.9.1. System monitoring
During sample testing, you can monitor the sample tray, the reaction tray and the reagent
tray in real time. See chapter 14 System monitoring for details.
7.9.2. Suspending and resuming operation
During the testing process, you can add reagent, or add samples. To do this, you need to
suspend the operation of the analyzer. Click the PAUSE button. The analyzer will
suspend mechanical movements, so that you can access the reagent and sample trays.
After you finished adding samples and/or reagents, you can resume operation by clicking
the START button again.
7.9.3. Emergency STOP
To immediately stop the testing process, click the "STOP" button. The instrument will
immediately stop any current action.
STOP key is not active during self-testing or bar code scanning. These operations cannot
be stopped.
7.9.4. Adding further samples
During the test process, you can add/edit further samples in sample registration form.
When you finished adding samples, click the Apply button to add your new samples to
the testing process.
7.10. Confirmation of test results

In the "test results" form, you could view, add, modify, delete, review, audit and printing
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the test result. For details, see chapter 7.3 Test result.
Attention
Sample with hemolysis, lipemia, jaundice will affect the test results.
Some substances in samples, such as drugs, anticoagulants, preservatives,
etc. will affect the test results. Incorrect parameter settings will affect test
results.
7.11. Finishing the analytical process

7.11.1. Exit the control software
When all test tasks have been finished, the system goes to standby status. Now you can
click Quit in main interface to exit the control software.
Attention
Before exiting the system, always wash cuvettes.
7.11.2. Power off
After exiting the control software, please power off the system in the following sequence
1. Power of printer
2. Power of display
3. Power of analysis part
4. Power of cooling system (if necessary)
7.11.3. Your tasks after power off
NOTE
Be sure to wear gloves, wear overalls during operation to avoid infection.
If necessary, wear protective glasses.
1. Place a reagent container cap over each reagent container.

2. Remove samples, calibration solutions and QC solutions.
3. Empty the waste bottle.
4. Clean the internal surface of the analyzer from any stains or spilled liquids.
ATTENTION
If you decided to power of the refrigeration part, you will need to put the
entire tray into a refrigerator.
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8. Sample testing
Sample test contains functions for registering samples and patient information.
Click the sample test button in the main window to enter Measurement / Sample Test
screen.
8.1. Registering samples for testing

The Sample Register tab allows registering samples for measurement.
The left side of the screen is a listing of measurement requests.
Each row represents a test, typically multiple tests requested for one individual sample.
Clicking on a row will bring up related data of the sample on the left side.
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The area in the right offers sample data entry options.

The box on the right shows the list of available test items and profiles (panels) for
selection.
Use the central area of the screen to register samples. Define Sample# and the position
(Sample pos.) where you wish to put the sample.
You can indicate whether the sample should be handled as a STAT (emergency) sample,
etc.
a. Enter the sample number at the first "sample number" input box. You may enter
ending sample ID to the second box, if the sample IDs to run are in increasing
order.
b. Enter the sample position at the "Sample Position" input box; if you are doing a
bulk registration, the sample position will be automatically increased.
c. In the "repeat" input box enter the number of samples tested, and if the starting
and ending sample numbers are the same, using the same sample location,
sample number automatically accumulate, if different, the number of repetitions
can only enter "1."
d. Enter the sample type, sample status, bar code, and other information.
e. If the emergency registration of samples, select the "STAT" option.
f. If the sample needs to be diluted, select the "dilute" option.
g. If a samples blank is required, select the "sample blank" option
h. Selected in the list to test all items, functions can also be used to detect the Profile
(panel) feature selection.
i. Click the "Apply" button to complete the task of testing applications.
j. If you want to delete a test task, first select the task in the task list, then click the
"Cancel" button.
ATTENTION
Samples can be registered, edited and deleted in Standby mode only.
Once you started measurements, you cannot edit or remove samples. To
modify samples or sample information, you need to STOP the measurement
process and make sure that the analyzer is in Standby state again.
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8.2. Test Result

Click "Test Result" to access the test result interface.
8.2.1. View the results
The sample information list shows all sample information for a specific date. Clicking on a
sample will show all test results of this sample.
If you want to check previous test results, you could change the test date and all sample
information of that day will be shown.
8.2.2. Delete a result
a Click the sample information in the list, right-hand click the test record which
needs to be deleted from test list, choose delete from popup menu.
b Click "Yes" button from the popup dialog box.
8.2.3. Print a report
Click "Print" button to enter into the batch printing interface.

Enter the start and the end sample number, then click "Print" button to complete the
printing of report.
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8.2.4. Viewing the reaction curve
Click "reaction curve" button, enter the viewing interface of reaction curve.
a Choose the sample number, test item, display mode for wavelengths. The
reaction curve of this item will be shown.
b If you want to view the absorbance value of a measurement point, choose the
"Point" from dropdown list, then the absorbance value of this measurement
point will be shown.
c You can print the reaction curve chart by clicking "Print" button.
8.2.5. Retesting samples
There are two registration methods for retesting a sample: automatic registration and
manual registration. Retesting a sample will not change the sample number, but you can
reset the used sample volume type for the sample. You can use normal, increment
and decrement via the Retest form.
Click "Retest" button, enter the settings interface of retest item.
8.2.5.1. Automatic registration
Click "Retest" button and enter "retest item setup" interface. After sample testing is
finished, the instrument will automatically add the sample information fulfilling retest
conditions to retest form according to the retest settings. The operator can change the
volume type of sample (normal/increment/decrement), and make the dilution setting.
Click Save button. The relation between sample volume type and sample volume as
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shown below:
The conditions for automatic registration Sample volume type
exceed the lower limit of linear range increment
exceed the upper limit of linear range decrement
reaction absorbance limit exceeds decrement
reaction absorbance limit exceeds 3.0ABS decrement
8.2.5.2. Manual registration
After the first time test, if some samples need to be retested, click Retest from test
result list, this item will be added to the retest list. Check the volume type of the retest
sample or if it needs to be diluted, click Save button.
Confirm the retest sample in "reset item setup" form, click on the "Apply" button to apply
the retest task.
Attention
Only the test results on that day can be retested.
You must firstly apply the retest task, then you could retest.
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8.3. Query Results

Click "Measurement / View results" to enter the result query interface.
You can query and search results by sample, you could also query the results by item.
8.3.1. Query by sample
Click Sample Query" to enter into the query by sample interface.

a. Input the start date and end date, input the name, sample number, medical record
number, there can be one or more querying conditions.
b. Click "Query" button, then you will check out the eligible sample information.
c. Click a record from the sample information list, then the test result of this sample
will be shown in the test results list.
d. If you want to modify, delete the sample information, right-click the sample
information list, click different menu item, you could complete this operation
respectively.
e. If you want to add, modify, delete the test results, right-click the sample
information list, click different menu item, you could complete this operation
respectively.
f. You could print the querying results by clicking the "Print" button.
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8.3.2. Query by item
Use the filter area to select records based on various conditions
a. Input the start date and end date, input the start sample number and end sample
number, choose the test item.
b. Click the Search button, you will get the test results that meet the conditions.
c. Click "Check All" check box, now all test results in list were selected, you can also
cancel all.
d. If you want to make batch modification to test results, you could input the values
in the correcting parameter input box.
e. Click "Modify" button, then all the test results in list will be modified according to
the modifier formula.
f. Click "Repeatability" button, all the test results in list will be on the statistics, work
out the maximum value, minimum value, range, average value, standard deviation,
coefficient of variation
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9. Calibration
Items calibration mainly contains functions of calibration registration, calibration results

querying.
Click item calibration button " ", enter "Calibration" interface, as shown below:
9.1. Calibration register

Click the "Calibration Register" tab to start registering calibration measurements.
a) Choose the test item which needs to be calibrated.

b) Choose the calibration type from dropdown list.
c) Click the "Apply" button.
d) If you want to delete a calibration task, then choose the task from task list (left
side), then click the "Cancel" button.
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9.2. Calibration Result

Click "calibration result" option to enter into the calibration result interface. In this
interface you could view, modify, add, delete, print the test results, or view and print the
calibration curve and reaction curve.
9.2.1. The editing of calibration results
a If you need to add the calibration results, right-click the blank of the list, select
"Add" from the pop-up menu, entry into the editing interface of calibration results,
select the item from dropdown list, then input the calibration results, click "Save"
button.
b If you need to modify the calibration results, right-click the item needs to be
modified, select "Modify" from the pop-up menu, entry into the editing interface
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of calibration results, select the item from dropdown list, then input the
calibration results, click "Save" button.
c If you want to delete the calibration results, right-click the record needs to be
deleted, select "Delete" from the pop-up menu.
d You could preview and print the calibration results by clicking the "Print" button.
9.2.2. View the calibration curve
Click calibration curve button, enter into the viewing of calibration curve interface.
After choosing the item and standard liquid from dropdown list, data like calibration curve,
absorbance, calibration method and calibration results will be shown.
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9.2.3. View the reaction curve
Click "reaction curve" button, enter into the viewing of reaction curve interface.
a. Choose the item, calibration solution, times, display mode of dominant

wavelength or vice wavelength, then the reaction curve of this item will be shown.
b. If you want to view the absorbance value of a metering point, choose the "Point"
from dropdown list, and then the absorbance value of this metering point will be
shown.
c. You could print the reaction curve chart by clicking "Print" button.
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10. Quality control
The aim to make quality control is in order to ensure the reliability of testing result for
each sample. The reliability of testing result contains two meanings, one is precision,
which means an excellent repeatability, and the small changes for daily tests, mainly to
eliminate or decrease the influence caused by random error; the other is high accuracy,
which means the testing result is correct, close to true value, mainly to eliminate or
decrease influence caused by systematic error.
Random error: means the difference of average values between test result and a result
which was gotten by infinite times tested under condition of repeatability, called random
error.
Systematic error: under condition of repeatability, its the difference between an average
value which was tested by numerous times and the true value be tested, called systematic
error. Its an error component whose expectation is not zero.
Accuracy: its the integration from test result between systematic error and random error,
it stands for the consistence degree between test result and true value.
Precision: stands for the random errors degree of test results. Precision means the
corresponding degree of test results when limitless times testing.
L-JLevey-JenningsQC chart: QC chart is one kind of graph with QC boundary. The QC

boundary is determined by the average value X which is get from repeat test of a
known specimen by using QC analysis method and the standard deviation SD .
X 2SD is Warning limit, X 3SD is out-of-control limit.
QC mainly contains functions of QC registration, QC result, intraday QC and interday QC.
Click QC button to enter into Quality Control interface, as shown below:
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10.1. QC register
Click QC button to enter into QC register interface. You can edit QC information in this
interface and you can also apply for a QC task.
a) Input the name, lot number, target value, standard deviation and position of QC
solution.
b) Choose a QC item from dropdown list.
c) Click Add button.
d) If you want to delete a QC information, first choose this information from the list,
then click Delete button.
e) If you want to apply for a QC task, first choose this information from list, then click
Apply button.
f) If you want to delete a QC task, choose this task from list, then click Cancel
button.
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10.2. QC result
Click QC result to enter into QC result interface. You could view, modify, add and
delete QC result.
a) If you want to see the QC result for a particular month, please choose the QC date,
then all the QC results within this month will be shown in list.
b) If you want to add a QC result, then choose the QC date, and then choose item, name,
lot number, input the QC result, click Add button.
c) If you want to modify a QC result, then choose this QC record and then input a
suitable QC result, and click Modify button.
d) If you want to delete a QC result, then choose this QC record, then click Delete
button.
e) You could view the reaction progress of QC test by clicking Reaction curve button.
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(a) Choose the item, name, lot number, times from dropdown list, then choose the
display model of main wavelength and vice wavelength, now the reaction curve of
this item will be showed.
(b) If you want to see the absorbance value of one measuring point, choose the detailed
checking point from Point dropdown list, now this points absorbance value will be
showed.
(c) You could click Print button to print the reaction curve.
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10.3. Within day QC

Click Intraday QC to enter into intraday QC interface. You could look at the analysis and
print the QC data of one particular day.
a) Choose QC date.
b) Choose the QC item, QC name and QC lot number from dropdown list.
c) When you finished choosing, this days QC data will be showed in QC chart, at the
same time, it will automatically calculate the actual measuring average value,
standard deviation, coefficient of variation and other data
d) Click Analyze button, to process the out-of-control analysis to QC data by using
Westgard multi rule.
e) Click Print button, you could print the QC data and QC chart.
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10.4. Daily QC
Click QC within a day to enter the QC interface. You could look at analysis and print the
QC data of one particular month.
a) Choose QC month.
b) Choose the QC item, QC name and QC lot number from dropdown list.
c) When you finished choosing, the chosen months QC data will be shown in the QC
chart, and average value, standard deviation, and coefficient of variation will be
automatically calculated.
d) Click Analyze button, to proceed to the out-of-control analysis to QC data by
using Westgard multi rule.
e) Click Print button to print the QC data and QC chart.
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11. Reagent information
11.1. Precautions about using reagents

The preparation, use and storage of reagents should be made with care. Reagent
containers should not have bubbles inside. As the reagent contains surfactant, presence of
bubbles during the test procedure, can lead to misjudgment of reagent volume: if the
probe touches the bubble, the sensor will detect reagent, and this can lead to an
inaccurate reagent aspirating volume. This will influence the result.
Never fill up a reagent container while old reagent is still inside.

If the added reagent came from a different manufacturer, or it comes from a different
batch, this may change reagent ingredient, and cause an inaccurate result.
To load reagents, open the reagent compartment lid and put the reagent bottle to the
designated position of reagent tray.
11.2. Registration of reagents

Click reagent information button under main interface, enter into reagent information
setting interface, as shown below:
(a) Input reagent bottles position: 1-44.
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(b) Choose reagent name, reagent type from dropdown list, input reagent lot number.
(c) Click Add button.
(d) If you want to delete reagent information, then choose information from list, then
click Delete button.
11.3. Reagent scan

Click Reagent Scan button, to make the instrument automatically detect remaining
reagent volume and test quantities. After scanning, the information will be shown in the
list. If the remaining test quantity is 0 or the remaining quantity is less than the set
quantity, the SW will mark corresponding reagents with yellow color.
During the testing procedure, when the probe goes to aspirate reagent, the probe will
also detect reagent level. At the same time, the remaining reagent volume and remaining
test quantities are calculated and updated.
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12. Settings
System setting contains functions of analytical items, combination item,

computational item, manual item, cross contamination, print setting.
Click Menu / Settings / Application data to enter into System setup interface, as
shown below:
12.1. Application setup

Click Analysis Item to enter into analysis item setting interface. You could edit
items parameter under this interface.
After correctly inputting item parameter, click Add button, to finish saving this
parameter, if you want to delete the item parameter, first choose this item from list,
then click Delete button. You could click Print button to preview and print the
items parameter.
12.1.1. Test item parameters
Click Analysis Parameter to enter into analysis parameter setting interface.
Explanation of fields on following page
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Explanation of fields
Item name: short form or abbreviation of the test name

Print name: test name on the printout
Item no.: unique identification when scanning.
Assay: Choose an analysis method according to the reagent manufacturers
requirements:
one point
end point method
Kinetics A method,
two-point method,
two point kinetics method
Unit: Choose the unit of the result.

Decimal: choose decimal digits for displaying test results
Main/Second-wavelength: there are 10 wavelengths to choose from 340nm, 405nm,
450nm, 492nm, 505nm, 546nm, 578nm, 620nm, 670nm, 700nm. Choose Main/Second
wavelengths according to reagent instruction. If tow wavelengths must be used, please
calculate with the absorbance of main wavelength minus absorbance of second
wavelength or the difference of absorbance variation ratio.
Factor: used for linear calibration methods.
Instrument factor (Y = aX + b): used to fine-tune calibration and to harmonize analyzer
results with a different (e.g. backup) analyzer. For the inspection of some tests, the test
result of analyzer may be higher or lower than the expected result or the results get from
other analyzers. In order to keep the test results consistent with expected result or the
results get from other analyzers.
Y: calibrated result
X: actual result of analyzer
a: slope value (Multiplication calibration factor)
b: Intercept value(Compensation calibration factor)
As long as the analyzers test result is the same as the expected value, or the results get
from both analyzers are the same, then you can keep defaults: a=1,b=0.
When the results of two instruments are different, you can calibrate with slope and
intercept values to get consistent results.
Sample volume setting: offers normal volume, incremental volume and decremented
volume. Each contains 3 input frames standing for sample volume, original sample volume
and dilute volume. All volumes are in microliter.
Normal volume: the normal volume of appointed sample.
Decremented volume (sample volume decrease): means the sample volume to be used
when the concentration exceeds the upper limit of reagent linear range.
Incremental volume (sample volume increase): means the sample volume to be used
when the concentration exceeds the lower limit of reagent linear range.
Sample volume: it is the sample volume aspirated from the sample container (sample cup
or test tube). The selectable range is 3-35ul. The total volume for sample and reagent
must not be more than 200ul, and must be less than 450ul.
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Dilution volume 1: If the sample is required a pre dilution, please set the sample volume
used to dilution. The input values are between: 15-35ul. When the sample is not required
to be pre dilution, you dont need to input values here.
Dilution volume 2: If the sample is required a pre dilution, please set the dilution volume.
The input values are between: 30-350ul, When the sample is not required to be pre
dilution, you dont need to input values here.
Reagent setting: includes reagent volume and reagent position.
Reagent volume: the unit is microliter, the reagent volume R1 is between 150-400ul,the
reagent volume R2 is between 20-200ul, if it is single reagent, please dont input reagent
volume R2.
Position: Reagent position on reagent tray. This parameter is set on reagent information
window. >> page: 81
Metering point: The analyzer will record the absorbance value for every 12 seconds,
which means every metering point amount to 12 seconds. Please input suitable metering
point according to reagent instructions, valid metering point should be inputted between:
2..49 (0 means no input).The actual absorbance value of each metering point could be
queried from reaction curve.
Linear range: Input the upper limit and lower limit of linear range according to reagent
instructions. If the test results exceed this range, the instrument will give an alarm, you
could choose to omit this inspection.
Absorbance limit: set the limit values of absorbance inspecting, choose reaction direction.
If absorbance exceeds this limit, the SW will give an alarm. You can omit this inspection.
Linear limit: on the method of Kinetics A. You could inspect the linearity, when exceeds
this limit, the SW will give an alarm. You could choose to omit this inspection.
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12.1.2. Reference range
Click Reference range to enter into reference range setting interface.
Specific reference value: If the age and sex of the patients are different, the
reference range is also different, now please use specific reference value range.
Click Specific value button, then to choose age unit, input the reference range of
different ago group and different sex.
Default reference value: if the reference value for different patient with same age
and sex, the reference value is the same, now please use default reference value
range. Click default value button, then input reference range.
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12.1.3. Other settings
a. Check the calibration method, calibration point(calibration solution

volume)according to reagent instruction.
b. Input the concentration and position of calibration solution.
c. If you need to check drift rate, discreteness, sensitivity, blank level on the
calibration test, choose the relevant item and input suitable checking values, the
new added item dont execute above checking by default.
d. When choosing the out of control judging condition, you should at least choose
one, the new added item will choose all the judging conditions by default.
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12.2. Profile setup

12.2.1. Test items
Click Profile Item to enter into profile item setting interface.
(a) Input the profile item name on profile item name input box.
(b) Choose the items you want to add.
(c) Click Add button. The combination name will be showed on the left list. Click the
name of profile item, all the items contained in this profile item will be shown.
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12.2.2. Calculated item
Calculated items are values calculated using various parameters, like A/G, TBil-DBil etc.
(a) Input parameters of item name, print name, unit and decimal digit.
(b) Use item code, figure, symbol to edit the formula for a calculated item. The formula
will be shown on the textbox of calculate formula.
(c) Click Add button to save the calculation.
(d) If you want to delete a calculated item, then choose this item from the list, then click
Delete button.
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12.2.3. Manual Item
Manual items are entries on the report that do not automatically change with results
provided with measured values.
You can add data (items) with reference ranges, however displayed values must be
entered manually.
The SW will evaluate the entered values against the normal ranges defined.
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12.3. Contamination settings

The avoid of cross contamination is a function to decrease or avoid the cross
contamination between analysis items. For some items, the reason is reagent formulas,
the degree of cross contamination is different, in order to eliminate the cross
contamination between reagents, when users are presetting the item, please try to
separate the cross contamination item with items of no cross contamination. If cant
completely separate them, you could avoid it according to setting cross contamination, to
effectively decrease the cross contamination between items. Using cross contamination
settings may decrease the test speed of instrument.
Click Cross Contamination to enter into cross contamination setting interface.
(a) Choose the item (from reagent) which one may cause a cross contamination, choose
relevant reagent type from type dropdown list.
(b) Choose the item (to reagent) which one may be contaminated and choose relevant
reagent type from type dropdown list.
(c) Click Add button, the set information will be shown in list, now the cross
contamination of reagent will be successfully set.
(d) If you want to delete a setting of cross contamination, please firstly choose the
information from list, then click Delete button.
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12.4. Print setup

Click Print Setup to enter into print setup interface.
12.4.1. Basic information setup
(a) Input title of report.

(b) Input remarks of report, it doesnt need to be input if you dont print.
(c) Input hospitals address and telephone, it doesnt need to be input if you dont print.
(d) Click the Save button, to save the basic information.
12.4.2. Item order setup
(a) Choose an item.

(b) Move this item to a suitable position by using Up, Down, Top, Bottom.
(c) After arranged item orders, click the Save button.
12.4.3. Report format setup
(1) Choose a report format

(a) Choose one kind of report format from drop-down list, this style will be displayed on
preview frame.
(b) Click Save button.
(2) Report format editing

Click Edit button to enter into report format editing interface.
(a) Set the font size of tile and content.
(b) Choose the printing paper. There are 3 paper sizes: A4,B5 and custom. If you want to
customize paper size, please choose customization mode, at the same time, input
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suitable values on width and height.

(c) Choose your printed information on option area.
(d) Click the Save button.
12.5. User settings

Click User Information to enter into user information interface. Only users with has
administrator rights may add, delete and revise users information.
On the input frame, please set user name, password, and confirm the password
(input the same password to both fields), user level (authority) ,then click Add
button,
Now you have set user information successfully, the information you entered is
displayed in the list on the left side.
If you want to delete user information, please click relevant user data and then click
delete button.
Administrator authority: user could look at ,set and test all the functions of instrument.
Operator authority: user could look at all the functions, set partial functions, and could
execute function of testing.
Query authority: user could look at partial functions, cant execute functions of setting
and testing.
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13. Miscellaneous items
The system management mainly contains functions of user information

management, data dictionary management, data maintenance, data statistics,
system log management.
13.1. Data management

13.1.1. Data dictionary
Click Data Dictionary to enter into data dictionary management interface.
First select data type, then input data in frame, click add button.
Now you added data information.
To delete data information, select the information and then click delete button.
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13.1.2. Data maintenance
Click Data Maintenance. This function allows backup or recover database, or

export and clean data.
(a) Click Backup button, the backup file will default to save to file D:\BACKUP\,the file
name is current date and time, the file format is: *.sav, regularly backup the data
base will protect data from missing.
(b) Select backup file from list, click Restore button, you can perform the data base
recovery. If the software fails because of some meaningless data, you could recover
previous data by using backup data base file.
(c) Select datasheet from list, click Export button to export the data.
(d) Select datasheet from list, meanwhile select starting date and ending date,
click Clear button to clean matching data.
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13.1.3. Data statistics
Click Data Statistics to enter into data statistics interface, you could analyze the
inspection department, inspection doctor and inspection doctors work-load.
Firstly select the starting date and ending date, then choose statistics type from
statistics type ,click Statistics button to finish statistics analysis, the result will be
showed in the form of a statistical chart. You could also click Print button to
preview and print this statistical chart.
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13.2. System log

Click System Log to enter into system log management interface. You could look
at and manage the log in, operating log and maintaining log.
Select the starting date and ending date, choose log type from log type,
click Query button, eligible logs information then would be showed in list, if you
want to delete the log information, first choose this information, then click delete
button.
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14. Maintenance menu
The system maintenance mainly contains communication setting, action debug,

parameter setting, cuvette (photometer calibration washing and so on.
Click system maintenance button in main interface, enter into system maintenance
interface, as shown below:
14.1.1. Serial port setup
Click communication setup to enter into interface of serial port setup, the mainly to
setting parameters are COM NO. and Baud rate.
The default communication port is: COM1,the default Baud rate is: 38400. Click Save
button to save your settings.
Attention:
Dont set the serial port when the instrument is running.
Your changed setting will come valid after restarting the online operation.
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14.2. Service menu

14.2.1. Action debug
Click Action Debug to enter into interface of movement debugging, you could detect
each modules status in this interface, and debug each movement.
1Sample needles debugging (horizontally reset, vertically reset, to the position of

reagent 11,to the position of reagent 2,to the sample position, to the cleaning well
positon, to reaction position, sample needles vertically movement, sample needles
cleaning),the cleaning time is:1-30 seconds.
2. Mixing needles debugging (horizontally reset, vertically reset, ,to the cleaning well
positon, to the reaction position, mixing needles vertically movement, debug the mixing
movement, mixing needles cleaning),the mixing time is :1-10 seconds, the cleaning time
is:1-30 seconds.
3. Reagent trays debugging (reset, shift of reagent, shift of sample), the shifting range
is:1-44.
4. Reaction trays debugging (reset, shift, rotate), the shifting range is:1-44,stopping range
is:1-44.
5. Pipettes debugging (reset, aspirate liquid, spit liquid), the aspirating and spiting liquid
range is:1-500
6. Washing modules debugging (reset, aspirating liquid, spit liquid).
7. Optical systems debugging (debug the signal. value of each wavelength).
8. Reset all: all the module of this instrument execute resetting movements.
9. Self-check: this function will check the status of each module.
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Attention:
The movement debugging could only be operated on standby status.
Dont engage any other activity on the instrument self-inspection process.
14.2.2. Instrument parameter
Click Instrument Parameter to enter into instrument parameter setting interface.

You could set all kinds of operating parameter of instrument in this interface, you
could also upgrade the firmware here.
(a) Select the part which you want to set parameter, input the correct parameter value.
(b) Click Test button, check if your setting is valid.
(c) If the setting is correct, please click Save button.
(d) Click Default button to load the default parameters.
Attention:
The instrument parameter setting could only be operated on standby status.
Dont engage any other activity on the instrument self-inspection process.
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14.1. Cuvette cleaning

Click Cuvette to enter into cuvette cleaning interface, you could clean the cuvettes
in this interface, and you could also check the cuvette blank.
The blank value of NO.0 cuvette is a value when all the light get through, it is used
as basic value, blank value of other cuvettes multiply 1.5 and then compare with
this basic value, if their difference is between 5000,it will be judged as a clean
cuvette, if beyond this range may consider to change a new cuvette.
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15. System monitoring
On the process of samples testing, you could exercise real time monitoring to the
sample/reagent disk, reaction disk of instrument.
Click button on the main interface, enter into interface of System

monitor as shown below:
15.1. Sample disk status

Click Sample Disk to enter into sample disk status interface.
Click the sample position which you want to check from sample disk monitor chart or
choose sample number from sample list, then relevant message will be showed on the
right browsing area.
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Sample status: we use different colors to show different status of sample disk.
Free: sample in this position is not registered.
Wait: sample in this position is registered, but not be added yet.
Analysis: a process for a registered sample from adding sample to before getting
result, all means analysis status.
Finish: the sample has gotten the test result.
15.2. Reagent disk status

Click Reagent Disk to enter into reagent disk status interface.
Click the reagent bottle position which you want to check from reagent tray monitor chart,
then relevant message will be showed on the right browsing area.
Reagent status: we use different colors to show different status of reagent disk.
Empty: reagent is not used to current test.
Normal: reagent surplus is not less than setting value.
Short: reagent surplus is less than setting value.
Absence: reagent is empty
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15.3. Reaction disk status

Click Reaction Disk to enter into reaction disk status interface.
Click the reaction cuvette position which you want to check from reaction disk monitor
chart, then relevant message will be showed on the right browsing area.
Reaction status: we use different colors to show different status of reaction disk.
Free: reaction cuvette is not used for current test.

R1: reaction cuvette has been added with reagent 1.
R2 reaction cuvette has been added with reagent 2.
Finish: test result of sample in this cuvette is available.
Dilute: this reaction cuvette is used to dilute the sample.
Dirty: the cuvette was found dirty during testing. It will not be used for tests.
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16. Alarm of instrument and solutions
16.1. Confirmation of alarm information
When instrument alarms, an alarm icon will appear on the upper left of main
interface. Enter into alarm message interface, you could check the alarm message,
when quit from alarm information interface, the alarm icon will disappear.
Click alarm information button under main interface, enter into

interface of Alarm information, as shown below:
a This list shows all the alarm message for the day, if you want to check previous
alarm messages, please choose a start date and an ending date, then click Query
button.
b If you want to check a detailed description and solutions for one alarm message,
please only click this piece of alarm message from list.
c If you want to delete an alarm message, please firstly choose this alarm message
from list, then click Delete button.
16.2. Type of alarm information

According to different alarm information content, the alarm information can be divided
into data alarm and failure alarm. The data alarms are all attention level alarm; the failure
alarms contain three different levels which are: attention, sample probe suspend, stop.
When different types of alarm messages are to be confirmed, the instruments action will
like below:
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Alarm information
Instruments action
type
The alarm (Attention level) which sees test result as object, the
Data alarm
instrument will go on testing.
It will appear on both data alarm and failure alarm. The test will go
Attention level alarm on, the operator can decide whether go on or stop testing
according to detailed situation.
The object to this alarm is instrument fault, the sample probe will
Sample probe
stop adding new sample, the samples which are already added to
suspend level alarm
reaction cuvettes will go on testing.
The object to this alarm is instrument fault. The instrument will
Stop level alarm stop all movement immediately, the test results will be not
reliable.
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16.3. Content of alarm information and solutions
Alarm Alarm Alarm information Alarm information detailed

Solutions to alarm information
code level brief description description
(1)Check if the communication cables connection is
Communication Send commands to host but receive right.
0-0 stop
exception no response. (2)Restart software of instrument, connect
computer for on-line operation.
(1)Make the debugging operation on the
movement debugging interface.
Reaction tray unit
0-1 stop Reset sensor is not detected. (2)Once the instrument is not back to normal or
exception
appear other fault, please contact with
maintenance staff.
Reaction tray unit
0-2 Stop Moving sensor is not detected. (2)Once the instrument is not back to normal or
exception
maintenance staff.
Mixing unit Anticlockwise limit sensor is not
1-1 stop (2)Once the instrument is not back to normal or
exception detected.
maintenance staff.
Mixing unit (1)Make the debugging operation on the
2-1 stop Upper limit sensor is not detected.
exception movement debugging interface.
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(2)Once the instrument is not back to normal or

maintenance staff.
Washing unit
exception Upper limit sensor is not detected.
maintenance staff.
Reagent tray unit
4-1 stop Reset sensor is not detected. (2)Once the instrument is not back to normal or
exception
maintenance staff.
Reagent tray unit
4-2 stop Moving sensor is not detected. (2)Once the instrument is not back to normal or
exception
maintenance staff.
Sample unit Anticlockwise limit sensor is not
exception detected.
maintenance staff.
Sample unit Clockwise limit sensor is not
exception detected.
maintenance staff.
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Sample unit
5-3 stop Timeout on waiting mixing bar reset. (2)Once the instrument is not back to normal or
exception
maintenance staff.
Sample unit
6-1 stop Upper limit sensor is not detected. (2)Once the instrument is not back to normal or
exception
maintenance staff.
Meet obstacle on vertical
6-2 stop Sample unit (2)Once the instrument is not back to normal or
movement.
exception appear other fault, please contact with
maintenance staff.
Pipette unit
7-1 stop Upper limit sensor is not detected. (2)Once the instrument is not back to normal or
exception
maintenance staff.
(1)Check if input the correct item parameter.
Pipette unit (2)Once the instrument is not back to normal or
7-2 stop Aspirating volume exceeded.
maintenance staff.
(1)Check if input the correct item parameter.
Pipette unit (2)Once the instrument is not back to normal or
7-3 stop Spiting volume exceeded.
maintenance staff.
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Data acquisition unit
8-1 Attention Timeout on reading baseline. (2)Once the instrument is not back to normal or
exception
maintenance staff.
Data acquisition unit
8-2 Attention Timeout on reading test result. (2)Once the instrument is not back to normal or
exception
maintenance staff.
(1)Restart the machine.
(2)Check if the float and waste pump could work
Temperature control Float switchs off not detected in 5 normally.
9-2 Attention
unit exception seconds (3) Once the instrument is not back to normal or
maintenance staff.
(1)Restart the machine.
(2)Change ambient temperature.
Temperature control
9-3 Attention Ambient temperature > 40. (3) Once the instrument is not back to normal or
unit exception
maintenance staff.
(1)Check if the heat belt and temperature sensor
Reaction trays temperature< could work normally.
Temperature control
9-4 Attention Ambient temperature of inside (2) Once the instrument is not back to normal or
unit exception
Instrument -7. appear other fault, please contact with
maintenance staff.
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could work normally.
9-5 Attention Temperature control Reaction tays temperature > 50. (2) Once the instrument is not back to normal or
unit exception appear other fault, please contact with
maintenance staff.
Reaction trays temperature< could work normally.
Temperature control
9-6 Attention Ambient temperature of inside (2) Once the instrument is not back to normal or
unit exception
Instrument +3. appear other fault, please contact with
maintenance staff.
Waste container is The float switch in the waste
9-7 Attention (1)Please empty the waste liquid in time.
full container floats.
Washing solution The float switch in the washing

9-8 (1)Please add washing solution in time.
Attention container is empty solution container falls.
The float switch in the distilled water

9-9 Attention container is empty (1)Please add distilled water in time.
container falls.
(1)Please check if the upgrade file is corrupt.

10-1 Stop FLASH upgrade unit Visit FLASH error.
(2)Try to restart the upgrade operation
exception
FLASH upgrade unit (1)Please check if the upgrade file is corrupt.
10-2 Stop Length of receiving FLASH data error.
exception (2)Try to restart the upgrade operation
EPCS
(1)Please check if the upgrade file is corrupt.
11-1 Stop EPCS upgrade unit
Visit EPCS error. (2)Try to restart the upgrade operation
exception
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EPCS upgrade unit (1)Please check if the upgrade file is corrupt.

11-2 Stop Length of receiving EPCS data error.
EPCS upgrade unit Write EPCS data address error. (1)Please check if the upgrade file is corrupt.
11-3 Stop
(1)Check if the using and placement of reagent is
correct.
20-1 Attention Absorbance The absorbance exceeded 3.0. (2)Check if there is impurity in sample.
exceeded (3)Check if there is scratch on the cuvette.
(4)Check if the water is pure.
(1)Check if there is impurity in sample.
Linearity checking On Kinetics method A, the linearity
20-2 Attention (2)Check if there is impurity in reagent.
limit exceeded exceed setting value.
(3)Please test after diluting sample.
(1)Check if the using and placement of reagent is
On Kinetics method or two point
Absorbance limit correct.
20-3 Attention kinetics method, the absorbance
exceeded (2)Check if the absorbance limit setting is correct.
exceed setting value.
3)Please test after diluting sample.
Linear range (1)Check the linear range setting value.
20-4 Attention Test results exceeded setting value.
exceeded (2)Please test after diluting sample.
(1)Check if the position of calibration solution is
The difference between
correct.
Drift rate checking approximately calculated
20-5 Attention (2)Check if input the correct concentration of
exceeded absorbance and tested absorbance
calibration solution.
exceed setting value.
(3)Recalibrate.
The absorbance difference for each (1)Check if the setting value is correct.
Discreteness
20-6 Attention standard liquid testing 2 times (2)Check if the cuvette is clean.
checking exceeded
exceed setting value. (3)Check if exists cross contamination.
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The difference between absorbance

of standard liquid 1(the average (1)Check if the setting value is correct.
value for 2 times tested)and (2)Check if input the correct concentration of
Sensitivity checking
20-7 Attention absorbance of the highest calibration solution.
exceeded
concentration standard liquid(the (3)Check if the calibration solution lose efficacy.
average value for 2 times tested) is (4) Check if the reagent lose efficacy.
less than setting value.
The twice tested average value for (1)Check if the setting value is correct.
Blank level checking
20-8 Attention absorbance of standard liquid 1 (2)Check if the reagent lose efficacy.
exceeded
exceeded setting value.
Sample volume is (1)Check if the sample volume is enough.
30-1 Attention Sample volume is not enough.
not enough (2)Check if the sample position is correct.
Reagent volume is (1)Check if the reagent volume is enough.

30-2 Attention Reagent volume is not enough.
not enough (2)Check if the reagent position is correct.
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17. Instrument Maintenance
In order to guarantee the reliability, good working order and life span, please strictly
follow the instructions to operate the system and maintain it regularly.
As for the unsolved problems and unmentioned maintenance problems in use, please
contact with the service department of Norma or the local distributor in time.
Warning:
Please don't do any maintenance that is not mentioned in this chapter.
It may cause the system damage and personal injury. If unauthorized
maintenance are carried out, it may cause the system damage and personal
injury, and also the promised clauses in the maintenance contract will not
be valid any more.
After the maintenance work, please make sure the system can work
normally. For safety, all the maintenance work are carried out with closing
the power of analyzing department and refrigeration department. Please
dont spill water, reagent and any liquid on the mechanical or electric parts.

During the maintenance processing, please be sure to wear gloves, work
clothes to protect from infection, and wear safety goggles in a pinch.
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17.1. Preparation for the maintenance

During the maintenance processing, the followed tools and cleaning agent may
be needed.
(1) Tools:
M3M5 inner allen key
Shape and screwdriver (large, middle, small)
Pincet
Clean gauze
Clean brush
Clean Q-tip
(2)Intensified cleaning agent:
Acidic intensified cleaning agent: 0.1mol/l hydrochloric acid
Alkalic intensified cleaning agent: 0.5(V/V) sodium hypochlorite
Attention:
Dont mix the acidic intensified cleaning agent and the alkalic intensified
cleaning agent.
Please use the appointed cleaning agent by Norma. If use other cleaning
agent, the veracity of the test results may be effected.
(3)Others
Ethanol
Disinfector
17.2. Daily Maintenance
17.2.1. Checking the Distilled water tank
Check as the follow steps
a Make sure the power supply of analysis unit is off or in stop stage;
b Check how much distilled water is left in the tank, if not enough to proceed to
the next step, then the test is finish.
c Unscrew (counter clockwise) the tank cap and remove the cap together with
the pickup tube and the sensor .After removing the tank cap (together with the
pickup tube and the sensor), place it on a clean table.
d Add the distilled water into the tank
e Screw (clockwise) the cap together with the pickup tube and the sensor back
onto the tank until secure.
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17.2.2. Checking the Waste liquid tank

Ware gloves and lab coat and if necessary, goggles .Disposals of waste water
in accordance with your local or national guidelines for biohazard waste
disposal, and consult the manufacturer or distributor of the reagents for
detailed.
Check as the follow steps
1 Check how much volume is left in the waste tank. If it is full, proceed to the
next step.
2 Unscrew (counter-clockwise) the cap of the tank together with the waste
tube and the sensor from the tank. After removing the cap together with the
waste tube and the sensor , place it on a clean table.
3 Empty the tank
4 Screw (clockwise) the cap (together with the waste tube and the sensor)
back onto the tank until secure.
Attention:
When placing the waste tank, ensure the top of the tank is lower than the
bottom of the upper cabinet .Ensure the waste tube is over the tank and not
blocked, bent or twisted. A blocked, bent or twisted waste tube may lead to
wastewater overflow that may damage the analyzer.
17.2.3. Checking the Probe
1 Check whether the probe is bent or dirty.

If bent, contact Norma Service Department of the local distributor.
If dirty, clean the surface with alcohol- extracting dishcloth.
2 During washing process, check the flow from the interior of the probe is
continuous and in the direction of the probe to the waste tank and have no
overflow. If so, there must be a block in the interior of the probe, clean it
Reference to 16.3.1.If not , check the connected tube and whether the tank is
full of waste water .
3 Check the position that the probe past, such as the position of reagent1,
reagent2, the position of washing pull, and the position of reaction. During
getting down process, it should be in the middle of the reagent bottle, washing
pull and reaction cup so that it will not reach obstacle.
As for detail operation, according to the operation under the window called
"equipment debugging" of " system setup".
If there is a big deviation of one of above position, please get into debugging
window to debug.
4 Check the movement of probe to see whether the movement is smooth and if
there is a big noise. To prevent the influence of stain on the kinematic axis of
the probe arm, please use clean rag to wipe the kinematic axis of probe arm at
any time.
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17.2.4. Checking the Mixing Probe
1 Check whether the mixing probe is bent or dirty.

If dirty, use acid or alkaline detergent-soaked clean rag and gently dean the exterior
of probe.
If bent, please contact Norma Service Department or Your local distributor.
2 When mixing, check whether the water ran over the tube of washing pool to the
waste tank. If so, check the connection between the tube and tank, or check if the
tank is full or not.
3 Check the position that the probe pass, such as the position of mixing tank and the
position for mixing. It should be in the middle of the above position during getting
down process. washing pull and reaction cup so that it will not reach obstacle. If
there is a big deviation of one of above position, please get into debugging window
to debug.
4 Check the movement of probe to see whether the movement is smooth and if there
is noise. To prevent the influence of stain on the kinematic axis of the probe arm,
please use clean rag to wipe the kinematic axis of probe arm at any time.
17.2.5. Checking the Washing system
1 Check whether the cleaning probe is bent or dirty.

If the exterior of the mixing probe is dirty, use acid or alkaline detergent-soaked
clean rag and gently dean the exterior of probe.
If bent, please contact Norma Service Department or your local distributor.
2 Turn off power, and move the cleaning probe to the position where the cleaning
probe can get into the cuvette. Check if there is any prangs .If one of the probe
cannot get into the cuvette because of the deviation of the position. If so, please
contact Norma Service Department or your local distributor.
3 During the cleaning process, check if there is much distilled water on the bottom of
the cuvette. If so, please contact Norma Service Department or your local
distributor.
4 Check if the tube which is connected with cleaning probe is damaged or not, If so,
please contact Norma Service Department or your local distributor.
5 Check if there is distilled water running over the cuvette during the cleaning
process. If so, please contact Norma Service Department or your local distributor.
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17.3. Weekly Maintenance
17.3.1. Cleaning the sample probe
Caution
The probe tip is sharp and can cause puncture wounds. To prevent injury,
exercise caution when working around the probe.
Biological pollution hazard:

Wear gloves and lab coat and, if necessary, goggles.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
The detail operation is as follows:
1 Place the power to OFF.

2 Remove the cover from the sample/reagent disk.
3 Remove the sample/reagent disk
4 Pull the probe arm to the highest point by hand. Rotate the probe arm to
move the probe to a position above the sample/reagent compartment and
convenient to operate.
5 Pinch acid or alkaline detergent-soaked gauze with tweezers and gently clean
the exterior of the probe until it is clean and smooth
6 After cleaning, gently pull the probe arm to its highest point and rotate the
probe arm to move th probe to a position above the wash well.
7 Load the sample/ reagent disk.
8 Close the cover.
17.3.2. Cleaning the mixing probe
1 Place the power to OFF.

2 Pull the mixer arm to the highest point by hand. Rotate the arm to move the
mixer to a position above the reaction compartment and convenient to
operate.
3 Pinch acid or alkaline detergent-soaked gauze with tweezers and gently clean
the exterior of the mixer bar until it is clean and smooth
4 After cleaning, gently pull the mixer arm to its highest point and rotate the
arm to move the probe to a position above the wash well.
5 Load the sample/ reagent disk.
8 Close the cover.
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17.3.3. Cleaning the sample probe
WARING
To operate carefully to avoid causing the mixing probe out of shape


1 Place the Power to OFF.
2 Pull the mixing probe arm to the highest point by hand. Rotate the probe arm to
move the probe to a position convenient to operate.
3 Pinch acid or alkaline detergent-soaked gauze with tweezers and gently dean the
exterior of the mixing probe until it is clean and smooth.
4 After cleaning, gently pull the probe arm to its highest point and rotate the
probe arm to move the probe to a position above the wash well.
17.3.4. Checking the injecting probe
WARING
To operate carefully to avoid causing the sampling probe out of shape


2 Pinch acid or alkaline detergent-soaked gauze with tweezers and gently dean
the exterior of the mixing probe until it is clean and smooth .Do not use
excessive force when cleaning the probe. Otherwise it may bend.
3 If there is grime on the principle axis of the cleaning probe, please pinch gauze
and gently dean the surface of the cleaning probe until it is clean, and smooth.
Do not use excessive force when cleaning the probe. Otherwise it may bend.
4 If the quantity of water in one cuvette is much different from the others, use
acupuncture pin to go through relevant water input probe (the short one is
water input probe).
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17.3.5. Cleaning the reagent / sample compartment
Warning:
Take care and prevent the sample and reagent in sample/ reagent
compartment spilled out. If necessary, put separately of all reagent and
sample which are taken off from sample/ reagent compartment.

Wear gloves and lab coat and, if necessary, goggles. Dispose of the used
gauze in accordance with your local or national guidelines for biohazard
waste disposal.

2 Press reagent/sample disk with hands to prevent its moving. At the same time
rotate the button on reagent/sample compartment anticlockwise.
3 Take out reagent/sample disk and put it on clean table.
4 Use clean gauze (water or disinfector-dipped gauze if necessary to clean the
inside of the compartment.
5 Load the sample/reagent disk.
6 Close the cover.
17.3.6. Cleaning the waste liquid tank

Wear gloves and lab coat and, if necessary, goggles. Dispose of the used
gauze in accordance with your local or national guidelines for biohazard
waste disposal.

2 Unscrew counter-clockwise) the cap (together with the waste tube sensor
and the leader). Put them on a clean table.
3 Empty the waste tank.
4 Wash the tank interior with clean water. Soak the tank with disinfector if
necessary.
5 Wipe water off the tank exterior, waste tube and sensor cable with clean
gauze .Use detergent to clean the stain on the sensor, if necessary.
6 Screw waste senor and its leader back onto the tank. Waste tube should not
be bent.
121
17.3.7. Cleaning the distilled water tank compartment

2 Unscrew (counter-clockwise) the cap (together with the distilled water pickup
tube and the sensor), and put them on a clean table.
3 Empty distilled water tank.
4 Wash the tank interior with clean water, if necessary, use disinfector.
5 Wipe water off the tank exterior, pickup tube and sensor cable with clean gauze.
If necessary, clean the stain of the sensor with detergent
6 Screw senor and its leader back onto the tank. Waste tube should not be bent.
17.3.8. Cleaning the panel of the analyzer
Caution


a Place the Power to OFF.
b Pinch alcohol-soaked gauze and gently dean the exterior of the panel of
analyzing unit, if necessary, use disinfector-soaked gauze.
122
17.4. Monthly Maintenance.
17.4.1. Cleaning the wash well of the Probe
Caution


2 Pull the probe arm to its highest point. Rotate the arm to move the probe
away from the wash well.
3 Clean the inside of the wash well and the place around the wash well with
cotton swabs.
4 Pull the probe arm to its highest point and rotate it to move the probe to a
position above the wash well.
17.4.2. Cleaning the wash well of the mixing probe
Warning:
Please operate with caution to avoid hurting by the probe tip.

The operation in details:
1. Place the main power to OFF.

2. Pull the rocker of the Mixing probe to the highest place, then turn it, and make the
Mixing probe far away from the washing well.
3. Clean the inside and outside parts of the Mixing probe washing well with cotton
swabs that dipped with alcohol until it is clean enough.
4. Turn the Mixing probe rocker to the above of the washing well.
123
17.5. Maintenance every six months
Cleaning dust screens

2. Clean the surface of the dust screen with cotton swabs that dipped with alcohol until
it is clean enough.
17.6. Irregular Maintenance
17.6.1. Cleaning the Sample Probe
When the probe can't pipette or the water flow is abnormal when washing, then the
probe may be clogged. We need to unplug the probe.
The clearing of the probe should follow the following steps: removing the probe,
cleaning the probe and fixing the probe.
17.6.1.1. Dismantle the Probe
Warning:
Please operate with caution to avoid hurting by the probe tip. .

Please wear gloves and work clothes to prevent infection when operating, if
necessary, please wear the protective goggles.
The gauze used for cleaning shouldn't be discarded arbitrarily, please
dispose them according to the relevant rule.
2 Little hard to Button up the edge of Probe case bottom, separate from the buckle of
the base ,take of the Probe arm as the picture 16.6.1.1 shown below:
3 Pull out the pipette on the top of the Probe, then take off the pin connector on the
liquid detection board .
124
Picture 16.6.1.1Sketch map of probe arm
4 Remove the 2 inner hexagon screws on Tumbler Stationary Bushing, take off probe
arm, screw off the "locknut" and snap spring clip of probe fixing component. Take off the
probe components. Do not lose the spring! Snap spring position as below16.6.1.2:
Picture 16.6.1.2 Sketch map of snap spring for probe fixing

5 Sketch map of Probe components dismount 16.1.6.3
125
Picture 16.6.1.3 Sketch map of dismantle probe components

17.6.1.2. Sample probe cleaning
Warning:
Please operate with caution to avoid injury or damage to the probe tip.

1.Unplug the Probe with an acupuncture needle.
2. Clean the surface of the probe with gauze that dipped with alcohol.
3. Dont fix the probe at first. Cover the needle tube with the pipette, and find the
option of Instrument Adjusting in the interface of System Setting. Then find the
option of Probe Washing, input the washing time. Then press the button of Test and
check the water flow of the probe.
Warning:
When testing the probe, before pressing the button of Test, you shouldnt
make the probe face the machine. So as to avoid the liquid splashing on the
machine..
4. If the water flow of the probe is continuous, then the washing is successful. Then you
could fix the probe.
126
16.6.1.3 sample probe fixing
Warning:

1. Place the main power of the analyzing part to OFF.
2. Put the new probe components with spring into fixing hole from the top of probe
arm. Put the "Fastening button" through probe tube and fix it good, then fix the "snap
spring"
3. Hold the probe tip and move up vertically, then release and check if the probe back to
the original position smoothly. If no, please repeat the actions above to install again.
4. Fix the "Tumbler stationary bushing" onto probe arm and fasten.
5. Adjust the probe is under the interface of "Action adjustment". Choose "reaction
position", click "Yes" button. Place the probe tip to the centric position of cuvette by
hand, then fasten 2 screws on the "Tumbler stationary bushing". Then make the probe
reset and take a look the position of probe tip. If it's not on the centric position, release
the screws and retest until meet the demands.
6. Match the 4 position pins on the probe case to the 4 holes on the side of probe base,
then press the probe case firmly. The probe fixing is OK, when you hear the pins clik to
their places.
17.6.1.3. Sample Probe replacement
Warning:

1. Power off the analyzer.
2. Withhold the downside edge of the sample probe cover and make it out of the
fastening button, meanwhile forward your strength upwards, you will take off the cover
3. Dismantle the sample probe components as the following sketch map 16.6.1.4 shows.
4. Replace with the new sample probe components
5. Adjust the probe is under the interface of "Action adjustment".
127
Picture 16.6.1.4 Sketch map of probe components
6. Exploded view of sample probe arm as 16.6.1.5:
128
Picture16.6.1.5 Exploded view of probe arm
17.6.2. Mixing probe replacement
Warning:

1. Place the main power of the analyzing part to OFF, turn the mixing probe to the place
that easy for replacing.
2. Unscrew the screws that used for tightening the Mixing probe. The Mixing probe
will be comes off at the same time.
3. Refer to the picture 16.6.2.2 replace the new Mixing probe deviceMixing probe
and fixed column)
4. Use the upper computer software to control the Mixing probe position and height
during mixing.
5. Sketch map of Mixing device
129
Picture 16.6.2.1 Sketch map of Mixing device
6. Sketch map of Mixing probe disassembly:
16.6.2.2 Sketch map of Mixing probe disassembly

7. Adjust all parts of the Mixing probe position on "Action Adjustment" interface.
130
17.6.3. Replacing the lamp
High-temperature Warning:
Before replacing the Light source lamp, you must turn off the power of the
Analyzing part for 20 minutes. Or else, the high temperature of the lamp
may burn your hands!
1. Turn off the power of the Analyzing part for 20 minutes, then begin to replace.
2. Unload the 6-connected cuvettes in the Calorimetric disc, then put them on a clean
place. Please refer to the following picture:
Picture 16.6.3.1 Sketch map of dismantle the cuvettes

3. Unscrew the 4 screws that used for fixing the Colorimetric disc, then take offPlease
pay attention to avoid bumping the washing system.
131
Picture 16.6.3.2 Sketch map of dismantle the cuvettes holder
4. Locate the light source bracket.
132
Picture 16.6.3.3 the light source bracket
5. Unload the light source bracket

Unload the Lamp Shelf with the Hexagon wrench of size 4refer to the picture below:
Picture 16.6.3.4 light source bracket
6. Unload the light source
133
Picture 16.6.3.5 Sketch map of dismantle the light source
Warning
During changing the light source lamp, please do not touch the new
lightsource lamp surface, in order to avoid dirtying the surface of the
lightsource lamp. You can wrap the light source with the clean lens paper
during the replacement.
7. Lightsource lamp position adjustment

When fix the light source bracket to the position as the picture shown below, the light
source bracket should be close to the outboard(the side of colorimetric disc axis)as
possible.Please don't fasten two inner hexagon screws which are used for fasten the
light source lamp. The power switch should be turn on, check the aperture projection
position, should be uniform distribution around the center hole of light path of lens
shelf .Fasten the screws a little after adjusting the position of light source bracket, Then
use the software of upper computer for the final adjustment.
134
Picture 16.6.3.6 Sketch map of the lightsource lamp position adjustment
8. Examine A/D value after adjustment

Under "action adjustment" interface, choose wavelength "340nm" in the drop-down
list,click OK, A/D value will be displayed,write down the A/D value. Then move light
source bracket little, click OK, check the A/D value againrepeat the operation,find out
the biggest A/D value. Then fasten 2 inner hexagon screws of light source bracket. Then
check again if the A/D value of the other wavelength are within A/D conversion range
(A/D range 5000-30000).
Picture 16.6.3.7 Check A/D Value
135
18. Appendix A System specifications
18.1. Analyzer performance

Machine type: discrete wet chemistry analyzer
Throughput: constant 200 tests/h (max. 280 t/h)
Testing methods:
Endpoint, Fixed time (Two-point), Kinetic (Velocity), Immunoturbidimetry.
Single-wavelength, Double-wavelength, Multi-wavelength
Single, double reagent, single, double wavelength testing
Test setting: Single term testing, Multiterm testing, Group item testing, Batch testing
Testing item: Routine Biochemistry, Specific protein, Electrolyte, Therapeutic medicine,
Urine, Myelencephalon, etc.
Item testing: Completely open for editing testing items, freely edit assemble and
setting to avoid the mutual interference items.
18.2. Sampling system

Sample tray: 44 sample position in total, the whole sample tray can be replaced
together and every position can be an emergency position, and the emergency position
can be inserted at anytime during the routine testing.
Sample tube specification: minim sample cup, vacuum test tube, plastic test tube.
Sample volume: 3ul-100ul1ul stepping
Sample probe: Multifunctional integrated sampling probe, which has automatic liquid
level detecting function and automatic inside and outside washing function.
Sample probe washing: Automatic completely wash inside and outside with warm
water, the contamination rate is less than 1%.
Sample processing: Automatic pre-dilution, automatic dilution and automatic retest.
Sample syringe: Long-life and high-precision ceramic piston. High-precision when
loading sample, hard wearing, low cost for maintenance.
Other optional function: Probe code scanning.
18.3. Reagent system

Reagent tray: 44 reagent positions, single and double reagent optional, reagent
position can be set freely, the whole reagent tray can be replaced together.
Reagent refrigeration: Continuous refrigeration for 24 hours in 415; Peltier
refrigeration; Independent power for refrigeration.
Reagent bottle: 25ml40ml; slope-bottom designed.
Reagent volume: 150ul300ul; Progressive increase by 1ul; Reagent blank can be
omitted automaticall when testing.
Reagent probe: Multifunctional integrated reagent probe, which has automatic liquid
level detecting function and vertical anti-collision function,
and can automatically wash inside and outside.
Reagent probe washing: Automatic completely wash inside and outside with warm
136
water, the contamination rate is less than 1%.

Sample syringe: Long-life and high-precision ceramic piston. High-precision when
loading sample, hard wearing, low cost for maintenance.
Other optional function: Probe code scanning.
18.4. Reaction system

Reaction tray: 48 reaction cups; 6 mm optical path; hard plastic cuvette; high
penetrability of the ultraviolet radiation(UV); acid resistant; corrosion-resistant;
semi-permanent use; low consumption; low cost.
Reaction mode: Post-spectrophotometry testing.
Volume of the reaction solution: 200ul300ul
Reaction time: 10 minutes or so.
Reaction temperature: 37; Temperature precision: 0.1
Constant temperature of Reaction tray: Directly heat the solid, no need for daily
maintenance
Mixing system: Independent mixing probe. For single reagent, mixing after adding the
reagent and sample; for double reagent, mixing after adding the second reagent.
Reaction cup washing: 8-step automatically washing , no need for manual intervention.
Adopting the technique of pumping out, deproteinized by adding washing liquid, then
washing and drying, so as to avoid cross contamination.
Water consumption: 5L/h or so.
Reaction cup washing liquid: Has the function of Warning for low liquid level of
washing liquid and distilled water.
Waste liquid processing: Has the function of Warning for high liquid level of the
waste liquid bucket.
18.5. Optical system

Light source: Halogen lamp, 6V/10W, life span2000hours.
Wavelengths: 10 filters: 340nm, 405nm, 450nm, 492nm, 505nm, 546nm, 578nm,
620nm, 670nm, 700nm
Optical beam width: 8nm
Detector: Photoelectric Diode Array
Absorbance range: 0.0003.000ABS
Resolution: 0.001ABS
Stray light sensitivity: 0.5%
18.6. Calibration and Quality control

Calibration mode: 9 mode: linearity (single point, double point and multi-point),
logit-log4p, logit-log5p, spline curve, exponential function, polynomial and parabola.
Calibration period: Set automatically or according to needs.
Quality control rule: Westgard, Cumulative Sum Check and Twin Polt. Allowing quality
control for three concentration.
Quality control mode: Real-time Quality control, daytime Quality control and daily
Quality control.
137
18.7. Operating system

Operating system: Windows 7
Screen resolution: minimum 1366x768
Data processing: Large capacity for testing results; show, save and print reaction
curve.
Report output: Edit and print complete report; content / format optional; paper
optional and editable; support network printing.
System interface: RS-232 Interface.
18.8. Working Environment

Power: 220V22V50HZ1HZ Power Consumption:400VA
Environmental temperature: 15C30C, Humidity:85%
Dimensions: 760(L)560(W)500(H) mm
Weight: 65kg
138
19. Appendix B
19.1. Accessories/Consumables
To ensure personal safety and system performance, please use supplies manufactured or
recommended by Norma only. Contact After-sales Department of Norma or local
distributors if necessary.
Accessory Specification Location Replacement period

Lamp 6V/10W under the reaction tray > 2000 hours
Sample Probe assembly Sample Probe arm Replace when damaged
Mixing probe assembly Mixing probe arm Replace when damaged
Cuvette 5mm6mm25mm reaction tray Replace when damaged
Cuvette shelf reaction tray Replace when damaged
Peristaltic pump Back panel of instrument Replace when damaged
Fuse 6A/220V, 520 Back panel of instrument Replace when damaged
Washing mechanism Washing mechanism Replace when damaged
assembly
Reagent bottle 30ml Reagent/Sample tray Consumable
Reagent bottle 20ml Reagent/Sample tray Consumable
Reagent bottle caps Reagent/Sample tray Consumable
Washing solution Washing tank Consumable
139
(ChangeLog)
Version Change Sections Affected Date Edited by

2.1E Operating system revised 4.1, 18.7 2014-02-11 CsMagyar
140

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normachem 2OO

Automated Biochemistry Analyzer

Norma Diagnostika GmbH

7.9.3. Emergency STOP ...................................................................................... 62

12.5. User settings ................................................................................................... 93

18.1. Analyzer performance .................................................................................. 136

This operators manual contains important safety and application instructions.

Who should read this manual?

1.1. Symbols and labels used in this manual

for In Vitro Diagnostic use

Biological pollution hazard

Anti-electric shock standard: Class B

Warning: High Temperature

1.1.2. Pictures used in this manual

1.2. Safety measures

1.2.3. Waste liquid treatment:

1.3. Operating environment

1.3.2. System operation

1.4. System maintenance

1.5. Sample handling

1.6. Reagent, calibration solution and blank solution

1.7. Parameter setting

1.8. Data backup

1.9. Manufacturers Statement

- The assembly manipulation, extension, re-debugging, improvement and

- Subassembly is disassembled, stretched, or re-debugged by non-Norma-staff;

1.10. Repair service

normachem 200 consists of

2.1. Analytical unit

Picture 2.1 instrument general view

2.1.1. Sample/reagent tray

The sample/reagent tray is used to hold reagents and samples.

The sample positions accept the following sample tubes:

The sample/reagent tray is located in the sample/reagent compartment. This

2.1.2. Dispensing mechanism

The dispensing mechanism is composed of:

Picture 2.1.2 dispensing mechanism

Sample volume 3-30l, with 1l increase

The dispensing mechanism is composed of:

The mixing mechanism is composed of:

Picture 2.1.3 mixing mechanism

Picture 2.1.4 Reaction tray

The reaction tray is located in a temperature-controlled chamber, keeping a constant

2.1.6. Washing unit

The cleaning system is an 8-step washing process.

2.2. Operation unit

2.3. Output unit

3.1. Hardware installation

3.3. Installation requirements

- normachem 200 is designed for indoor operation

3.3.2. Power requirements

- Power supply: alternating current 198V-242V, 50/601Hz, grounded

3.3.3. Requirement for humidity and temperature

- The storage temperature of this system is 0-40, fluctuation <2C/hour

The humidity and temperature for working

- The working temperature of this system is 1530fluctuation <2/H

- The temperature of water supply is 5~50.

3.3.5. Space requirements

Picture 3.1.2.5 Installation diagram

3.3.6. Connection of accessories and serial port

BIOLOGICAL POLLUTION HAZARD

Picture 3.1.3 The connection chart on the back of analyzer

3.3.7. Installation and removal of the sample/reagent tray