CL-1000i Operation Manual V3.0 en

CL-1000i Chemiluminescence
Immunoassay Analyzer
Operator’s Manual
Volume I
© 2015-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2016-12.
CL-1000i Chemiluminescence Immunoassay Analyzer i

Operator's Manual
Copyright
Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey
any license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any
other derivative work of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
, , , , BeneView, WATO,
BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and
other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
ii CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
Copyright
Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be
liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
 all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel;
 the electrical installation of the relevant room complies with the applicable national
and local requirements; and
 the product is used in accordance with the instructions for use.
WARNING
It is important for the hospital or organization that employs this equipment to carry out a
reasonable service/maintenance plan. Neglect of this may result in machine breakdown
or personal injury.
NOTE
This equipment must be operated by skilled/trained clinical professionals.
CL-1000i Chemiluminescence Immunoassay Analyzer iii

Operator's Manual
Copyright
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation
or other charges or liability for direct, indirect or consequential damages or delay
resulting from the improper use or application of the product or the use of parts or
accessories not approved by Mindray or repairs by people other than Mindray authorized
personnel.
This warranty shall not extend to:
 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
 Malfunction of the instrument or part whose serial number is not legible enough.
 Others not caused by instrument or part itself.
Customer service department

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, High-tech
industrial park, Nanshan, Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail Address: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680
EC - Representative
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
iv CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
Preface
This manual contains the instructions necessary to operate the product safely and in
accordance with its function and intended use. Please read this manual thoroughly before
using the product. This manual is based on the maximum configuration and therefore
some contents may not apply to your product. If you have any questions, please contact
us.
Observance of this manual is a prerequisite for proper performance and correct
operation, and it ensures patient’s and operator’s safety. All graphics including screens
and printouts in this manual are for illustration purpose only and must not be used for
any other purposes. The screens and printouts on the product should prevail.
The product can be operated via both mouse and touchscreen. This manual describes
operating instructions based on the use of mouse.
CL-1000i Chemiluminescence Immunoassay Analyzer v

Operator's Manual
Safety Information
This chapter provides you with safety symbols used in this manual and their meanings,
summarizes the safety hazards and operating precautions that should be considered
seriously when the instrument is being operated, and lists the labels and silkscreen that
have been applied to the instrument and their indications.
CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-1

Operator's Manual
Safety Information
Safety Symbols
Safety symbols are used in this manual in order to remind you of the instructions
necessary to operate the product safely and in accordance with its function and intended
use. A safety symbol and text constitutes a notice as shown in the table below:
When you Text Then

see
WARNING Read the statement following the symbol. The
statement is alerting you to an operating hazard
that can cause personal injury.
BIOHAZARD Read the statement following the symbol. The
statement is alerting you to a potentially
biohazardous condition.
CAUTION Read the statement following the symbol. The
statement is alerting you to a possibility of system
damage or unreliable results.
NOTE Read the statement following the symbol. The
statement is alerting you to information that
requires your attention.
Safety Information-2 CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
Safety Information
Summary of Hazards
Introduction
Observe the following safety precautions when using the product. Ignoring any of these
safety precautions may lead to personal injury or equipment damage.
WARNING
If the product is used in a manner not specified by our company, the protection provided
by the product may be impaired.
Electric Shock Hazards

Observe the following instructions to prevent electric shock.
WARNING
When the POWER is turned on, users other than the servicing personnel authorized by our
company must not open the rear cover or side cover.
Spillage of reagent or sample on the product may cause equipment failure and even
electric shock. Do not place sample and reagent on the panel of the analzyer. In case of
spillage, switch off the power immediately, remove the spillage and contact our
Customer Service Department or your local distributor.
Moving Parts Hazards

Observe the following instructions to prevent personal injury caused by moving parts.
WARNING
When the system is in operation, do not touch such moving parts as probe, gripper,
reagent carousel, cuvette loader, aspirate station and sample transportation part.
Do not put your finger or hand into any open part when the system is in operation.

Operator's Manual
Safety Information
Sample, Calibrator and Control Hazards

Observe the following instructions to protect against the biohazardous infection by
samples, calibrators and control samples.
BIOHAZARD
Inappropriately handling samples, controls and calibrators may lead to biohazardous
infection. Do not touch the samples, control samples, calibrators, substrate, wash buffer,
mixtures or waste with your bare hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the samples, control or calibrator, follow the standard
laboratory safety procedure and consult a doctor.
Reagent and Wash Solution Hazards

Observe the following instructions to protect against the biohazardous infection by
reagents and wash solution.
WARNING
Reagents and concentrated wash solutions are corrosive to human skins. Exercise caution
when using reagents and concentrated wash solution. In case your skin or clothes contact
them, wash them off with clean water. If reagents or wash solution spills into your eyes,
rinse them with water and consult an oculist.
Waste Hazards
Observe the following instructions to prevent environmental pollution and personal
injury caused by waste.
BIOHAZARD
Some substances contained in reagent, control, calibrator, substrate, wash buffer and
waste are subject to regulations of contamination and disposal. Dispose of the waste in
accordance with your local or national rule for biohazard waste disposal and consult the
manufacturer or distributor of the reagents for details.
Wear gloves and lab coat and, if necessary, goggles.
System Disposal Hazards

Observe the following instructions to dispose of the waste analyzer.
WARNING
Materials of the analyzer are subject to contamination regulations. Dispose of a waste
analyzer in accordance with your local or national rule for waste disposal.
Fire and Explosion Hazards

Observe the following instructions to prevent fire and explosion.
WARNING
Ethanol is flammable substance. Please exercise caution while using ethanol around the
instrument in order to prevent fire and explosion.

Operator's Manual
Safety Information
Removal of Analyzer from Use for Repair or Disposal

To minimize or eliminate the hazards involved in repair, transportation, disposal
process, please observe the following instruction.
WARNING
When the analyzer is not in use, for example, in repair, transportation or disposal
process, please clean and sterilize the parts (the probe, etc.) or surfaces that may
cause biohazdards and remind the person who handles the device of the related hazards.
Changing Waste Tank
WARNING
When the waste tanks are used to hold the liquid waste, please empty the waste tank
before and after the test in order to avoid overflowing of the liquid.
When changing the waste tank, please quickly place the waste tubing into the empty one
in order to prevent the waste liquid from dropping.

Operator's Manual
Safety Information
Precautions on use
Introduction
To use the product safely and efficiently, pay attention to the following operating
precautions.
Intended Use
WARNING
The instrument is an automated analyser for immunological analysis. It is designed for
determination of analytes in serum, plasma and other human body fluids.
When drawing a clinical conclusion, please also refer to patients’ clinical symptoms and
other test results.
Environment Precautions
CAUTION
Evaluate the electromagnetic environment prior to operating the system.
Please install and operate the system in an environment specified by this manual.
Installing and operating the system in other environment may lead to unreliable results
and even equipment damage.
To relocate the system, please contact our Customer Service Department or your local
distributor.
Installation Precautions
NOTE
The safety of any system incorporating the equipment is the responsibility of the
assembler of the system.
Cleaning and Decontamination
CAUTION
Appropriate decontamination is carried out if hazardous material is spilled onto or into
the equipment.
No decontamination or cleaning agents are used which could cause a HAZARD as a result
of a reaction with parts of the equipment or with material contained in it. Strong acid or
alkaline solutions are forbidden to clean the equipment.
If there is any doubt about the compatibility of the decontamination or cleaning agents
with parts of the equipment or with material contained in it, please contact our
customer service department or the local distributor.

Operator's Manual
Safety Information
Electromagnetic Noise Precautions
CAUTION
Electromagnetic noise may interfere with operations of the system. Do not install
devices generating excessive electromagnetic noise around the system. Do not use such
devices as radio transmitters in the room housing the system. Do not use other display
monitors around the system.
Do not use other medical instruments around the system that may generate
electromagnetic noise to interfere with their operations.
Do not use this device in close proximity to sources of strong electromagnetic radiation
(e.g. mobile phones or radio transmitters), as these may interfere with the proper
operation.
The electromagnetic environment should be evaluated prior to operation of the device.
This device has been designed and tested to CISPR 11 Class A, and in a domestic
environment may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
CAUTION
It is the manufacturer's responsibility to provide equipment electromagnetic
compatibility information to the customer or user.
It is the user's responsibility to ensure that a compatible electromagnetic environment
for the equipment can be maintained in order that it will perform as intended.

Operator's Manual
Safety Information
Operating Precautions
CAUTION
 Take the clinical symptoms or other test results of the patient into considerations
when making a diagnosis based on the measuring results produced by the system.
 Operate the system strictly as instructed by this manual. Inappropriate use of the
system may lead to unreliable test results or even equipment damage or personal
injury.
 Do not open the shielding cover when the system is in operation; otherwise starting
analysis is not permitted.
 When using the system for the first time, first run calibrations, and then QC tests to
make sure the system is in proper state.
 Be sure to run QC tests every time when you use the system, otherwise the result may
be unreliable.
 Do not uncover the reagent carousel when the system is in operation. Keep the
reagent carousel cover closed. Please close the front door before the auto loader
when the system is in operation.
 The operation unit is a personal computer with the operating software installed.
Installing other software or hardware on the computer may interfere with the system
operation. Do not run other software when the system is working.
 Computer virus may destroy the operating software or test data. Do not use the
computer for other purposes or connect it to the Internet. If the computer is infected
by virus, please install anti-virus software to check for and clear virus.
 Do not touch the display, mouse or keyboard with wet hands or hands with chemicals.
 Do not place the MAIN POWER to ON again within 10 seconds since placing it to OFF;
otherwise the system may enter the protection status. If it does so, place the MAIN
POWER to OFF and place it to ON again.
 Do not start measurement after starting up the system until incubation is finished and
the status becomes Standby.
System Home
CAUTION
 Please do not pull out the drawer structures during Home process.

Operator's Manual
Safety Information
Maintenance and Servicing Precautions
CAUTION
 Maintain the system strictly as instructed by this manual. Inappropriate maintenance
may lead to unreliable results, equipment damage or personal injury.
 To wipe off dust from the system surface, use a soft, clean and wet (not too wet)
cloth soaked with soap water rather than organic solvents such as ethanol. After
cleaning, wipe the surface and dry with dry cloth.
 Switch off all the powers and disconnect the power plug before cleaning. Take
necessary measures to prevent liquid ingression, otherwise equipment damage or
personal injury may be caused.
 Replacement of such major parts as probe and syringe assembly must be followed by a
calibration.
 The tubing of peristaltic pump may fail after a long period of work, which will lead to
dispersion overflow or wash buffer inlet failure. Replace the pump tubing regularly.
 If the system fails and needs servicing, contact our Customer Service Department or
your local distributor. The system may need to be stopped or transported during
servicing, which will probably cause biohazards, electric shock hazards and moving
part hazards. Exercise caution when preparing the system for servicing.
Sample Precautions
CAUTION
 Use samples that are completely free of insoluble substances like fibrin or suspended
matter; otherwise the probe may be blocked.
 Medicines, anticoagulants or preservative in the samples may lead to unreliable
results.
 Hemolysis may affect sample test result. Avoid using such samples or re-collect the
sample.
 Store the samples properly. Improper storage may change the compositions of
samples and lead to unreliable results.
 Sample volatilization may lead to unreliable results. Do not leave the sample open for
a long period.
 The system has a specific requirement on the sample volume. Refer to this manual for
proper sample volume.
 Load samples to correct positions on the sample carousel before the analysis begins;
otherwise reliable results may not be obtained.

Operator's Manual
Safety Information
Reagent, Calibrator and Control Precautions
CAUTION
 Use proper reagents, calibrators and controls on the system.
 Select appropriate reagents supplied by Mindray according to the performance
characteristics of the system. Consult our company or our authorized distributor for
details. Based on the reaction principle and applicable scope of the reagents supplied
by Mindray, other chemiluminescence immunoassays can be performed on this
instrument as well.
 Store and use the reagents, calibrators and controls strictly as instructed by our
company; otherwise, reliable results or best performance of the system may not be
obtained. Improper storage of reagents, calibrators and controls may lead to
unreliable results and bad performance of the system even in validity period.
 Perform calibration and QC test after changing the reagents, otherwise reliable
results may not be obtained.
Rack Feeder System Precautions
BIOHAZARD
Do not take away the sample rack from rack feeder system during test running to prevent
skin damage or infection due to contact with the moving parts.
CAUTION
Do not push sample rack in the lane during test running. Beware of pinching.
NOTE
When programming samples in non-bar code mode, please confirm that the program
information matches the sample ID, so as to avoid result error due to sample being
omitted or too many samples being placed on the rack.
Data Archiving Precautions
NOTE
The system automatically stores the data to the built-in hard disk. Data loss, however, is
still possible due to mis-deletion or physical damage of the hard disk. You are
recommended to regularly archive the data to such medium as CDs.
To avoid data loss caused by unexpected power failure, a UPS (uninterrupted power
supply) is recommended.

Operator's Manual
Safety Information
External Equipment Precautions
WARNING
For operating instructions and precautions of the computer and printer, please refer to
their operation manuals.
External equipment connected to the analogue and digital interfaces must be complied
with relevant safety and EMC standards (e.g., IEC 60950 Safety of Information Technology
Equipment Standard and CISPR 22 EMC of Information Technology Equipment Standard
(CLASS B)). Any person, who connects additional equipment to the signal input or output
ports and configures an IVD system, is responsible for ensuring that the system works
normally and complies with the safety and EMC requirements. If you have any questions,
consult the technical services department of your local representative.
Tube and Liquid Container Precautions
WARNING
When the tube or the part that contain liquid become aged or damaged, please stop its
use immediately and contact our customer service department or your local distributor
to check and replace it.
Loading Cuvette
WARNING
Before loading the cuvettes, please use a pair of new gloves and do not use the gloves
which have contacted with the reagent or sample.
Please do not remove the package of the cuvettes until you are about to load them.
Human scurf may affect the test results. Please avoid dropping the scurf into the
cuvettes when loading them.

Operator's Manual
Safety Information
Instrument Labels and Silkscreen

Introduction
The following non-warning and warning labels and silkscreen are used on the product for
system identification and operating instruction.
For the label marked with , please consult the related documentations in order to
find out the nature of the potential HAZARDS and any actions which have to be taken to
avoid them.
Check the labels regularly for cleanliness and integrity. If any of the labels becomes vague
or peels off, contact our Customer Service Department or your local distributor for
replacement.
Non-Warning Labels and Silkscreen

Serial number
This symbol, contained in the product label which is attached to the rear cover of the
system, indicates the production serial number of the product.
Date of manufacture
system, indicates the manufacture date of the product.
In vitro diagnostic equipment

system, indicates that the product is in vitro diagnostic equipment.
European community representative

system, indicates the name and address of the authorized representative in the European
Community.

Operator's Manual
Safety Information
WEEE label
The following definition of the WEEE label applies to EU member states only.
The use of this symbol indicates that this product should not be treated as household
waste. By ensuring that this product is disposed of correctly, you will help prevent
bringing potential negative consequences to the environment and human health. For
more detailed information with regard to returning and recycling this product, please
consult the distributor from whom you purchased the product.
Power Switch: On
This label is located beside the power switch. When the switch is placed to upper position,
the power is on and the instrument is started.
Power switch: Off

This label is located beside the power switch. When the switch is placed to lower position,
the power is off
Network interface
This symbol located on the network interface indicates the connection between the
analyzer and the operation unit.
Electrical ground
This symbol indicates an electrical ground.

Operator's Manual
Safety Information
Load/Unload reagent bottle

This label is located near the reagent carousel. Load and unload reagent bottles according
to the illustration.
Load/Unload substrate
This label is located near the substrate load area. Loosen the bottle cap after loading
substrate, and tighten it before unloading
Sample rack indicator

This label is located on the door of sample loading area, used to indicate the number of the
sample rack lane and the rack status.
Interfaces for fluid connection

This label located on the fluid connection interfaces indicates the connection of fluid
tubing.

Operator's Manual
Safety Information
Warning Labels
Biohazard Warning
This label indicating the risk of biohazardous infection is located in the following
positions:
 Probe Wash Well
 Analyzing Unit Waste Outlet
 Cuvette waste container
 Sample aspirate port
 The door of the sample loading area
Moving Parts Warning

This symbol and text indicating the hazardous moving parts is located in the following
positions:
 probe
 Gripper

Operator's Manual
Safety Information
Probe Collision Warning

This symbol and text located on the lower left corner of the reagent carousel remind you
of not opening the carousel cover and track cover to prevent from damaging the probe.
Shielding Cover Warning

This symbol and text located on the metal sheet below the shielding cover reminds you of
keeping the shielding cover closed while the system is running tests to prevent injury
caused by probe and various liquids.

Operator's Manual
Table of Contents
Intellectual Property Statement ............................................................................................................................................. ii

Responsibility on the Manufacturer Party........................................................................................................................ iii
Warranty ........................................................................................................................................................................................ iv
Exemptions..................................................................................................................................................................... iv
Customer service department ................................................................................................................................ iv
EC - Representative ..................................................................................................................................................... iv
Preface ················································································································· v
Safety Information ··································································································· 1
Safety Symbols .............................................................................................................................................................................. 2

Summary of Hazards .................................................................................................................................................................. 3
Introduction ..................................................................................................................................................................... 3
Electric Shock Hazards ................................................................................................................................................ 3
Moving Parts Hazards .................................................................................................................................................. 3
Sample, Calibrator and Control Hazards .............................................................................................................. 4
Reagent and Wash Solution Hazards .................................................................................................................... 4
Waste Hazards ................................................................................................................................................................ 4
System Disposal Hazards ........................................................................................................................................... 4
Fire and Explosion Hazards ...................................................................................................................................... 4
Removal of Analyzer from Use for Repair or Disposal .................................................................................. 5
Changing Waste Tank .................................................................................................................................................. 5
Precautions on use...................................................................................................................................................................... 6
Introduction ..................................................................................................................................................................... 6
Intended Use ................................................................................................................................................................... 6
Environment Precautions ......................................................................................................................................... 6
Installation Precautions .............................................................................................................................................. 6
Cleaning and Decontamination................................................................................................................................ 6
Electromagnetic Noise Precautions ....................................................................................................................... 7
Operating Precautions ................................................................................................................................................ 8
System Home .................................................................................................................................................................. 8
Maintenance and Servicing Precautions ............................................................................................................. 9
Sample Precautions ...................................................................................................................................................... 9
Reagent, Calibrator and Control Precautions..................................................................................................10
Rack Feeder System Precautions ..........................................................................................................................10
CL-1000i Chemiluminescence Immunoassay Analyzer I

Operator's Manual Version:3.0
Table of Contents－Volume I
Data Archiving Precautions ....................................................................................................................................10

External Equipment Precautions .........................................................................................................................11
Tube and Liquid Container Precautions ............................................................................................................11
Loading Cuvette ...........................................................................................................................................................11
Instrument Labels and Silkscreen.......................................................................................................................................12
Introduction ...................................................................................................................................................................12
Non-Warning Labels and Silkscreen ...................................................................................................................12
Warning Labels ............................................................................................................................................................15
Table of Contents ····································································································· I
1 System Description ······························································································1-1
1.1 Installation Requirements and Procedure .............................................................................................................. 1-2

1.1.1 Installation Requirements........................................................................................................................... 1-2
1.1.2 Installation Procedure .................................................................................................................................. 1-5
1.2 Hardware Structure ......................................................................................................................................................... 1-7
1.2.1 System Overview ........................................................................................................................................... 1-7
1.2.2 Sample Handling System.......................................................................................................................... 1-10
1.2.3 Reagent Handling System ....................................................................................................................... 1-12
1.2.4 Sampling System ......................................................................................................................................... 1-14
1.2.5 Substrate System......................................................................................................................................... 1-16
1.2.6 Optical Measurement Reaction system ............................................................................................. 1-19
1.2.7 Dispersion System...................................................................................................................................... 1-20
1.2.8 Cuvette Load and Transport System ................................................................................................... 1-20
1.2.9 Reaction Liquid Mixing System............................................................................................................. 1-22
1.2.10 Operation unit ........................................................................................................................................... 1-23
1.2.11 Output Unit ................................................................................................................................................. 1-23
1.2.12 Accessories and Consumables ............................................................................................................ 1-23
1.3 Optional Modules ........................................................................................................................................................... 1-24
1.3.1 Introduction................................................................................................................................................... 1-24
1.3.2 Touch screen monitor ............................................................................................................................... 1-24
1.3.3 Monitor bracket .......................................................................................................................................... 1-24
1.3.4 Printer ............................................................................................................................................................. 1-24
1.3.5 Built-in sample bar code reader ............................................................................................................. 1-24
1.3.6 Built-in Reagent bar code reader........................................................................................................... 1-24
1.3.7 Other Optional Modules............................................................................................................................ 1-24
1.4 Software Description ................................................................................................................................................... 1-25
1.4.1 Main Screen................................................................................................................................................... 1-25
1.4.2 Function Icons and Program Structure .............................................................................................. 1-27
1.4.3 Using a Mouse .............................................................................................................................................. 1-34
1.4.4 Using a Touchscreen .................................................................................................................................. 1-35
1.4.5 Using Online Help ....................................................................................................................................... 1-36
1.5 System Specifications .................................................................................................................................................. 1-38
1.5.1 Technical specifications ........................................................................................................................... 1-38
1.5.2 Power Supply Requirements.................................................................................................................. 1-40
1.5.3 Environmental Requirements ................................................................................................................ 1-40
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Operator's Manual
1.5.4 Dimensions and Weight ........................................................................................................................... 1-41

1.5.5 Input device ................................................................................................................................................... 1-41
1.5.6 Output device ................................................................................................................................................ 1-41
1.5.7 Noise and Fuse............................................................................................................................................. 1-41
1.5.8 Communication Interface........................................................................................................................ 1-41
1.5.9 Safety Classification.................................................................................................................................... 1-42
1.5.10 EMC Requirements .................................................................................................................................. 1-42
2 General Operating Procedure ·················································································2-1
2.1 General Operating Procedure ...................................................................................................................................... 2-2

2.2 Check before Powering On ........................................................................................................................................... 2-3
2.2.1 Checking Power Supply .............................................................................................................................. 2-3
2.2.2 Checking Printing Paper ............................................................................................................................. 2-3
2.2.3 Check Waste Tank Connection ................................................................................................................. 2-3
2.2.4 Checking Probes............................................................................................................................................. 2-3
2.2.5 Checking Rack Feeder System .................................................................................................................. 2-3
2.2.6 Checking Cuvette, Wash Buffer, Substrate and Probe Wash Solution....................................... 2-3
2.2.7 Checking Waste Container ......................................................................................................................... 2-3
2.3 Powering on ....................................................................................................................................................................... 2-4
2.3.1 Powering On the System............................................................................................................................. 2-4
2.3.2 Powering On the System after Long Time Shutdown ..................................................................... 2-4
2.3.3 Starting the Operating Software ............................................................................................................... 2-5
2.4 Checking System Status.................................................................................................................................................. 2-6
2.4.1 Check Consumable Status ........................................................................................................................... 2-6
2.4.2 Printer Status ................................................................................................................................................... 2-9
2.4.3 LIS Status ........................................................................................................................................................... 2-9
2.4.4 Checking Analyzer Status............................................................................................................................ 2-9
2.4.5 Checking Alarm Status ............................................................................................................................... 2-10
2.4.6 Checking Reagent/Calibration Status ................................................................................................. 2-11
2.4.7 Checking Maintenance Status ................................................................................................................ 2-12
2.4.8 Checking Subsystems................................................................................................................................ 2-13
2.5 Preparing Reagents ...................................................................................................................................................... 2-16
2.5.1 Prepare Immunoassay Reagents .......................................................................................................... 2-16
2.5.2 Preparing Wash Buffer ............................................................................................................................. 2-19
2.5.3 Loading Wash Solution ............................................................................................................................. 2-20
2.5.4 Loading Substrate ....................................................................................................................................... 2-21
2.5.5 Loading Sample Diluent............................................................................................................................ 2-22
2.5.6 Loading and Retrieving Cuvette Tray ................................................................................................. 2-23
2.5.7 Emptying Solid Waste Container .......................................................................................................... 2-24
2.6 Calibration........................................................................................................................................................................ 2-25
2.7 Quality Control................................................................................................................................................................ 2-26
2.8 Programming routine samples ................................................................................................................................ 2-27
2.8.1 Programming Routine Samples ............................................................................................................ 2-27
2.8.2 Loading Routine Samples ........................................................................................................................ 2-31
2.8.3 Running Routine Samples ....................................................................................................................... 2-32
CL-1000i Chemiluminescence Immunoassay Analyzer III

2.9 Programming STAT Samples .................................................................................................................................... 2-34

2.9.1 Programming STAT Samples .................................................................................................................. 2-34
2.9.2 Loading STAT Samples .............................................................................................................................. 2-37
2.9.3 Start Analysis ................................................................................................................................................ 2-38
2.10 Test Status and Emergency Stop........................................................................................................................... 2-39
2.10.1 Checking Reagent Status ....................................................................................................................... 2-39
2.10.2 Viewing Consumable Status ................................................................................................................. 2-39
2.10.3 Checking Reagent Overview ................................................................................................................ 2-40
2.10.4 Viewing Status of Racks ......................................................................................................................... 2-42
2.10.5 Emergency Stop ........................................................................................................................................ 2-44
2.11 Daily Maintenance ..................................................................................................................................................... 2-45
2.12 Shutdown and Log Off .............................................................................................................................................. 2-46
2.12.1 Log Off........................................................................................................................................................... 2-46
2.12.2 Shut Down................................................................................................................................................... 2-47
2.13 Check after Powering Off ........................................................................................................................................ 2-48
2.14 Storing the Analyzer after Long Term Shutdown .......................................................................................... 2-49
3 System Setup ·····································································································3-1
3.1 System Setup ...................................................................................................................................................................... 3-2

3.1.1 Introduction...................................................................................................................................................... 3-2
3.1.2 Sample and Test Options............................................................................................................................. 3-2
3.1.3 Instrument Setup Options .......................................................................................................................... 3-3
3.1.4 Print Setup ........................................................................................................................................................ 3-7
3.1.5 Bar Code Setup ................................................................................................................................................ 3-7
3.1.6 Host Communication Setup ....................................................................................................................... 3-7
3.1.7 User Accounts and Permissions ............................................................................................................... 3-7
3.2 Chemistry Setup................................................................................................................................................................ 3-8
3.2.1 Introduction...................................................................................................................................................... 3-8
3.2.2 Editing and Deleting Chemistries ............................................................................................................ 3-8
3.2.3 Define/Edit Chemistries ............................................................................................................................. 3-9
3.2.4 Flag Qualitative Result ............................................................................................................................... 3-11
3.2.5 Slope/Offset Adjustment .......................................................................................................................... 3-11
3.2.6 Reference/Critical RangeSetup ............................................................................................................. 3-12
3.3 Calibration Setup ........................................................................................................................................................... 3-17
3.4 QC Setup ............................................................................................................................................................................ 3-18
4 Operation Theories ······························································································4-1
4.1 Principles of Measurement .......................................................................................................................................... 4-2

4.1.1 Introduction...................................................................................................................................................... 4-2
4.1.2 Sandwich Method .......................................................................................................................................... 4-2
4.1.3 Competitive Method ..................................................................................................................................... 4-3
4.2 Analysis Mode .................................................................................................................................................................... 4-4
4.2.1 Introduction...................................................................................................................................................... 4-4
4.2.2 One-step Method ........................................................................................................................................... 4-4
4.2.3 Two-step Method........................................................................................................................................... 4-4
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4.3 Calibration Math Model ................................................................................................................................................. 4-7

4.3.1 Introduction...................................................................................................................................................... 4-7
4.3.2 Quantitative Calibration Type and Calculation ................................................................................... 4-7
4.3.3 Calculating Cutoff Value for Qualitative Analysis ............................................................................... 4-7
5 Reagents ···········································································································5-1
5.1 Overview.............................................................................................................................................................................. 5-2

5.1.1 Introduction...................................................................................................................................................... 5-2
5.1.2 Reagent/Calibration Screen Overview ................................................................................................. 5-2
5.1.3 Consumable Management Window ........................................................................................................ 5-3
5.2 Customizing Reagent Display...................................................................................................................................... 5-4
5.2.1 Introduction...................................................................................................................................................... 5-4
5.2.2 Customizing Reagent Information ......................................................................................................... 5-4
5.3 Sorting Reagents ............................................................................................................................................................... 5-5
5.3.1 Introduction...................................................................................................................................................... 5-5
5.3.2 Sorting Reagents............................................................................................................................................. 5-5
5.4 Consumable Inventory Alarm Limits Setup ........................................................................................................... 5-6
5.4.1 Introduction...................................................................................................................................................... 5-6
5.4.2 Setting Up Consumable Inventory Alarm Limits................................................................................ 5-6
5.5 Printing Reagent Information ..................................................................................................................................... 5-7
5.5.1 Introduction...................................................................................................................................................... 5-7
5.5.2 Printing Immunoassay Reagent Information .................................................................................... 5-7
5.5.3 Printing Consumable Information .......................................................................................................... 5-7
5.6 On-line Load of Reagents .............................................................................................................................................. 5-8
5.6.1 Introduction...................................................................................................................................................... 5-8
5.6.2 On-line Load of Immunoassay Reagents and Sample Diluent...................................................... 5-8
5.6.3 On-line Load of Substrate, Wash Solution and Wash Buffer ........................................................ 5-9
5.7 Off-line Load of Reagents ........................................................................................................................................... 5-10
5.7.1 Introduction................................................................................................................................................... 5-10
5.7.2 Off-line Load of Immunoassay Reagent and Sample Diluent .................................................... 5-10
5.7.3 Off-line Load of Substrate, Wash Solution and Wash Buffer ..................................................... 5-10
5.8 On-line Replacement of Reagents ........................................................................................................................... 5-11
5.8.1 Introduction................................................................................................................................................... 5-11
5.8.2 On-line Replacement of Immunoassay Reagent and sample diluent ..................................... 5-11
5.8.3 On-line Replacement of Substrate ........................................................................................................ 5-11
5.8.4 On-line Replacement of Wash Buffer .................................................................................................. 5-12
5.9 Off-line Replacement of Reagents ........................................................................................................................... 5-13
5.9.1 Introduction................................................................................................................................................... 5-13
5.9.2 Off-line Replacement of Immunoassay Reagent and Sample Diluent ................................... 5-13
5.9.3 Off-line Replacement of Substrate, Wash Solution and Wash Buffer ..................................... 5-13
5.10 Loading and Retrieving Cuvette Tray and Emptying Solid Waste Container ..................................... 5-14
5.10.1 On-line Loading and Retrieving Cuvette Tray............................................................................... 5-14
5.10.2 On-line Emptying Solid Waste Container ....................................................................................... 5-14
5.10.3 Off-line Loading and Retrieving Cuvette Tray and Emptying Solid Waste Container .. 5-14
5.11 Unloading Reagents.................................................................................................................................................... 5-15
CL-1000i Chemiluminescence Immunoassay Analyzer V

5.11.1 Introduction ................................................................................................................................................ 5-15

5.11.2 Unloading Immunoassay Reagents and Sample Diluents ......................................................... 5-15
5.11.3 Unloading Substrate ................................................................................................................................ 5-15
6 Calibration ········································································································6-1
6.1 Overview.............................................................................................................................................................................. 6-2

6.2 Calibration Status and Alarm ....................................................................................................................................... 6-3
6.3 Calibration setup .............................................................................................................................................................. 6-4
6.3.1 Introduction...................................................................................................................................................... 6-4
6.3.2 Define a Calibrator ........................................................................................................................................ 6-4
6.3.3 Input Calibration Master Curve Information ..................................................................................... 6-4
6.3.4 Assign Calibrator Position ......................................................................................................................... 6-5
6.3.5 Select Sample Cup Type ............................................................................................................................... 6-6
6.3.6 Delete Calibrator ............................................................................................................................................ 6-6
6.4 Calibration Options ......................................................................................................................................................... 6-7
6.4.1 Extending Calibration Time ...................................................................................................................... 6-7
6.4.2 Reject .................................................................................................................................................................. 6-7
6.4.3 Individual Bottle Calibration...................................................................................................................... 6-8
6.5 Auto Calibration ................................................................................................................................................................ 6-9
6.5.1 Introduction...................................................................................................................................................... 6-9
6.5.2 Auto Calibration Setup ................................................................................................................................. 6-9
6.5.3 Auto Calibration Reminding ...................................................................................................................... 6-9
6.5.4 Removing Auto Calibration .................................................................................................................... 6-10
6.6 Calibration Test .............................................................................................................................................................. 6-11
6.6.1 Requesting Calibrations ........................................................................................................................... 6-11
6.6.2 Cancel calibration request ...................................................................................................................... 6-12
6.6.3 Loading Calibrator...................................................................................................................................... 6-12
6.6.4 Running Calibrations................................................................................................................................. 6-12
6.7 Recalling Calibration Results .................................................................................................................................... 6-14
6.7.1 Recalling Current Calibration Result .................................................................................................. 6-14
6.7.2 Recalling History Calibration Results ................................................................................................. 6-14
6.7.3 Archiving Calibration Results................................................................................................................. 6-15
6.7.4 Recalling Calibration Data ....................................................................................................................... 6-15
6.7.5 Calibration Trends ...................................................................................................................................... 6-15
7 Quality Control ···································································································7-1
7.1 Overview.............................................................................................................................................................................. 7-2

7.1.1 Introduction...................................................................................................................................................... 7-2
7.1.2 Quality Control Operating Procedure..................................................................................................... 7-2
7.1.3 QC Alarms.......................................................................................................................................................... 7-2
7.1.4 QC result flags .................................................................................................................................................. 7-2
7.1.5 Control Status ................................................................................................................................................... 7-3
7.2 QC Setup ............................................................................................................................................................................... 7-4
7.2.1 Introduction...................................................................................................................................................... 7-4
7.2.2 Defining/Editing a Control ......................................................................................................................... 7-4
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7.2.3 Selection of Chemistries .............................................................................................................................. 7-5

7.2.4 Set Up Control Concentrations ................................................................................................................. 7-6
7.2.5 Assign Control Position ............................................................................................................................... 7-7
7.2.6 Setting Up QC Rules ....................................................................................................................................... 7-8
7.2.7 Deleting a Control........................................................................................................................................... 7-9
7.3 QC Evaluation .................................................................................................................................................................. 7-10
7.3.1 Introduction................................................................................................................................................... 7-10
7.3.2 Evaluation of Single Control .................................................................................................................... 7-10
7.3.3 Two-Control Evaluation ........................................................................................................................... 7-11
7.4 Auto Quality Control ..................................................................................................................................................... 7-13
7.4.1 Introduction................................................................................................................................................... 7-13
7.4.2 Auto QC Setup............................................................................................................................................... 7-13
7.4.3 Auto Quality Control .................................................................................................................................. 7-14
7.4.4 Removing Auto QC Status ........................................................................................................................ 7-14
7.5 QC Test ............................................................................................................................................................................... 7-15
7.5.1 Programming Control Samples ............................................................................................................. 7-15
7.5.2 Loading Control Samples ......................................................................................................................... 7-16
7.5.3 Running Control Samples ........................................................................................................................ 7-17
7.5.4 Auto QC ........................................................................................................................................................... 7-18
7.6 Recalling Control Results ............................................................................................................................................ 7-19
7.6.1 Control Sample Results.............................................................................................................................. 7-19
7.6.2 Recalling L-J Chart ...................................................................................................................................... 7-20
7.6.3 Recalling Twin-Plot Chart........................................................................................................................ 7-22
7.6.4 Recalling QC Data ........................................................................................................................................ 7-23
7.6.5 Recalling QC Summary ............................................................................................................................. 7-25
8 Sample Programming and Processing ········································································8-1
8.1 Overview.............................................................................................................................................................................. 8-2

8.2 Sample Programming and Processing ..................................................................................................................... 8-3
8.2.1 Introduction...................................................................................................................................................... 8-3
8.2.2 Adding Samples ............................................................................................................................................... 8-3
8.2.3 Adding/Modifying Chemistries ................................................................................................................ 8-4
8.2.4 Rerunning samples........................................................................................................................................ 8-4
8.2.5 Programming Diluted Samples................................................................................................................. 8-8
8.2.6 Sample Analysis Mode .................................................................................................................................. 8-8
8.2.7 Sample Management ................................................................................................................................. 8-10
8.3 Clear Samples .................................................................................................................................................................. 8-12
8.3.1 Introduction................................................................................................................................................... 8-12
8.3.2 Clearing Samples ......................................................................................................................................... 8-12
8.4 Unpositioned Samples ................................................................................................................................................. 8-13
8.4.1 Introduction................................................................................................................................................... 8-13
8.4.2 Assigning Positions .................................................................................................................................... 8-13
8.5 Release Sample Position ............................................................................................................................................. 8-15
8.5.1 Introduction................................................................................................................................................... 8-15
8.5.2 Releasing Rack Position............................................................................................................................ 8-15
CL-1000i Chemiluminescence Immunoassay Analyzer VII

8.5.3 Auto Release of Samples ........................................................................................................................... 8-15

8.6 Customizing Sample Information ........................................................................................................................... 8-17
8.6.1 Introduction................................................................................................................................................... 8-17
8.6.2 Customizing Sample Information......................................................................................................... 8-17
8.7 Customizing Patient Demographics ...................................................................................................................... 8-18
8.7.1 Introduction................................................................................................................................................... 8-18
8.7.2 Customizing Patient Demographics .................................................................................................... 8-18
8.8 Sample and Chemistry Lists ...................................................................................................................................... 8-19
8.8.1 Introduction................................................................................................................................................... 8-19
8.8.2 Sample List..................................................................................................................................................... 8-19
8.8.3 Chemistry List .............................................................................................................................................. 8-20
8.9 Optimizing Result Display.......................................................................................................................................... 8-22
8.9.1 Introduction................................................................................................................................................... 8-22
8.9.2 Optimizing Result Display ....................................................................................................................... 8-22
8.10 Results Recall................................................................................................................................................................ 8-24
8.10.1 Introduction ................................................................................................................................................ 8-24
8.10.2 Displaying Current Results ................................................................................................................... 8-24
8.10.3 Recalling Current Results ...................................................................................................................... 8-25
8.10.4 Viewing Abnormal Sample................................................................................................................... 8-26
8.10.5 Displaying History Results .................................................................................................................... 8-26
8.10.6 Recalling History Results ...................................................................................................................... 8-27
8.10.7 Review Sample Results ........................................................................................................................... 8-28
8.10.8 Viewing/Editing Patient Demographics......................................................................................... 8-28
8.10.9 Reaction Data ............................................................................................................................................. 8-29
8.10.10 Transmitting Results to LIS Host ..................................................................................................... 8-30
8.10.11 Printing Results ...................................................................................................................................... 8-31
8.10.12 Deleting Results ...................................................................................................................................... 8-32
8.10.13 Customizing Result Display ............................................................................................................... 8-33
8.10.14 Recalculating Results ............................................................................................................................ 8-35
8.10.15 Compensating Results ......................................................................................................................... 8-36
8.10.16 Recalling Result Trend ........................................................................................................................ 8-36
8.10.17 Archiving Results ................................................................................................................................... 8-37
8.11 Test Statistics ................................................................................................................................................................ 8-39
8.12 Result Statistics ............................................................................................................................................................ 8-41
8.13 Charge Statistics .......................................................................................................................................................... 8-43
8.13.1 Charge setup .............................................................................................................................................. 8-43
8.13.2 Search charges .......................................................................................................................................... 8-43
9 Data processing ··································································································9-1
9.1 Data Import and Export................................................................................................................................................. 9-2

9.1.1 Introduction...................................................................................................................................................... 9-2
9.1.2 Import/Export Chemistries....................................................................................................................... 9-2
9.1.3 Data Archive ..................................................................................................................................................... 9-4
9.1.4 Sending Sample Results and QC Results to LIS ................................................................................... 9-4
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9.2 Print Setup .......................................................................................................................................................................... 9-5

9.2.1 Introduction...................................................................................................................................................... 9-5
9.2.2 General Print Setup Options ...................................................................................................................... 9-5
9.2.3 Setting up Default Template....................................................................................................................... 9-6
9.2.4 Deleting Template .......................................................................................................................................... 9-6
9.2.5 Editing Print Template ................................................................................................................................. 9-6
9.2.6 Importing Print Template........................................................................................................................... 9-6
9.2.7 Defining Chemistry Print Order ............................................................................................................... 9-7
9.3 Sample Reports .................................................................................................................................................................. 9-9
9.3.1 Introduction...................................................................................................................................................... 9-9
9.3.2 Single Sample Report .................................................................................................................................... 9-9
9.3.3 Multi-sample Report .................................................................................................................................. 9-10
9.3.4 Sample Summary Report ......................................................................................................................... 9-11
9.3.5 Chemistry Summary .................................................................................................................................. 9-12
9.3.6 Sample/Control List Report .................................................................................................................... 9-13
9.3.7 Chemistry List Report ............................................................................................................................... 9-14
10 Chemistries ····································································································10-1
10.1 Special calculations .................................................................................................................................................... 10-2

10.1.1 Introduction ................................................................................................................................................ 10-2
10.1.2 Defining/Editing a Calculation ............................................................................................................ 10-2
10.1.3 Enabling/Disabling Calculations ........................................................................................................ 10-3
10.1.4 Deleting User-Defined Calculations ................................................................................................... 10-4
10.1.5 Running Calculations............................................................................................................................... 10-4
10.2 Panels............................................................................................................................................................................... 10-5
10.2.1 Introduction ................................................................................................................................................ 10-5
10.2.2 Defining/Editing a Panel....................................................................................................................... 10-5
10.2.3 Adjusting Display Order of Panels ...................................................................................................... 10-6
10.2.4 Deleting Panels .......................................................................................................................................... 10-6
10.2.5 Running Panels.......................................................................................................................................... 10-6
10.3 Chemistry Configuration ......................................................................................................................................... 10-7
10.3.1 Introduction ................................................................................................................................................ 10-7
10.3.2 Enabling Chemistry ................................................................................................................................. 10-7
10.3.3 Disabling Chemistries ............................................................................................................................ 10-7
10.3.4 Customizing Chemistry Display Order ............................................................................................. 10-8
10.4 Default Panel ................................................................................................................................................................ 10-9
10.4.1 Introduction ................................................................................................................................................ 10-9
10.4.2 Default Panel .............................................................................................................................................. 10-9
10.4.3 Running Default Panel for Patient Samples ................................................................................... 10-9
10.5 Masking/Unmasking Chemistries .....................................................................................................................10-11
10.5.1 Introduction ..............................................................................................................................................10-11
10.5.2 Masking/Unmasking Chemistries...................................................................................................10-11
10.6 Version of Closed-Reagent Chemistry ..............................................................................................................10-12
10.6.1 Introduction ..............................................................................................................................................10-12
10.6.2 Viewing Version of Closed-Reagent Chemistry ..........................................................................10-12
CL-1000i Chemiluminescence Immunoassay Analyzer IX

11 System Setup Options ·······················································································11-1
11.1 Home ............................................................................................................................................................................... 11-2

11.1.1 Introduction ................................................................................................................................................ 11-2
11.1.2 Homing System ......................................................................................................................................... 11-2
11.2 User and password setup ........................................................................................................................................ 11-3
11.2.1 Introduction ................................................................................................................................................ 11-3
11.2.2 Defining a User.......................................................................................................................................... 11-3
11.2.3 Modifying a User....................................................................................................................................... 11-4
11.2.4 Assigning/Modifying Permissions.................................................................................................... 11-4
11.2.5 Deleting User .............................................................................................................................................. 11-5
11.3 Auto Startup .................................................................................................................................................................. 11-6
11.3.1 Introduction ................................................................................................................................................ 11-6
11.3.2 Auto Startup ................................................................................................................................................ 11-6
11.4 Dictionary ...................................................................................................................................................................... 11-7
11.4.1 Introduction ................................................................................................................................................ 11-7
11.4.2 Defining, Editing and Deleting Data Option ................................................................................... 11-7
11.5 Auto Maintenance Setup ......................................................................................................................................... 11-9
11.5.1 Introduction ................................................................................................................................................ 11-9
11.5.2 Auto Maintenance Setup ....................................................................................................................... 11-9
11.6 Software Version .......................................................................................................................................................11-10
11.6.1 Introduction ..............................................................................................................................................11-10
11.6.2 Software version .....................................................................................................................................11-10
11.7 Voice Tone Setup .......................................................................................................................................................11-11
11.7.1 Introduction ..............................................................................................................................................11-11
11.7.2 Importing Audio Files ...........................................................................................................................11-11
11.7.3 Setting Up Voice Tone ...........................................................................................................................11-11
11.8 Sample Analysis Mode Setup ................................................................................................................................11-13
11.8.1 Introduction ..............................................................................................................................................11-13
11.8.2 Sample Analysis Mode Setup..............................................................................................................11-13
11.9 Air Bubble Detection Setup...................................................................................................................................11-14
11.9.1 Introduction ..............................................................................................................................................11-14
11.9.2 Air Bubble Detection Setup ................................................................................................................11-14
11.10 Consumable Check Before Test ........................................................................................................................11-15
11.10.1 Introduction ...........................................................................................................................................11-15
11.10.2 Consumable Check Before Test ......................................................................................................11-15
11.11 Part Setup ..................................................................................................................................................................11-16
11.11.1 Introduction ...........................................................................................................................................11-16
11.11.2 Part setup ................................................................................................................................................11-16
12 Use of Bar Code ······························································································12-1
12.1 Sample Bar Code Reader .......................................................................................................................................... 12-2

12.1.1 Introduction ................................................................................................................................................ 12-2
12.1.2 Sample Bar Code Setup ........................................................................................................................... 12-3
12.1.3 Programming Bar-Coded Routine Samples ................................................................................... 12-4
12.1.4 Programming Bar-Coded STAT Samples ......................................................................................... 12-4
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12.1.5 Adding new samples or chemistries ................................................................................................. 12-5

12.1.6 Results Recall ............................................................................................................................................. 12-6
12.2 Reagent Bar Code Reader ........................................................................................................................................ 12-7
12.2.1 Introduction ................................................................................................................................................ 12-7
12.2.2 Loading Bar-Coded Reagents ............................................................................................................... 12-7
12.3 Bar Code Reader Maintenance .............................................................................................................................. 12-8
12.3.1 Introduction ................................................................................................................................................ 12-8
12.4 Troubleshooting Bar Code Reader........................................................................................................................ 12-9
13 LIS ···············································································································13-1
13.1 Overview ........................................................................................................................................................................ 13-2

13.2 Host Communication ................................................................................................................................................ 13-3
13.2.1 Introduction ................................................................................................................................................ 13-3
13.2.2 Connection between PC and LIS Host.............................................................................................. 13-3
13.2.3 Host Communication Parameters ..................................................................................................... 13-4
13.2.4 Defining Chemistry Code....................................................................................................................... 13-6
13.3 Programming Samples with LIS Host ................................................................................................................ 13-7
13.3.1 Introduction ................................................................................................................................................ 13-7
13.3.2 Programming Functions ....................................................................................................................... 13-7
13.4 Result Transmission.................................................................................................................................................. 13-9
13.4.1 Introduction ................................................................................................................................................ 13-9
13.4.2 Result Transmission Setup................................................................................................................... 13-9
13.4.3 Manually Sending Results to LIS Host ............................................................................................. 13-9
13.5 Troubleshooting LIS ................................................................................................................................................13-10
14 Diagnostics·····································································································14-1
14.1 Overview ........................................................................................................................................................................ 14-2

14.2 Photometer diagnosis .............................................................................................................................................. 14-3
14.2.1 Introduction ................................................................................................................................................ 14-3
14.2.2 Dark Current Count Diagnosis ........................................................................................................... 14-3
14.2.3 Photon Count Diagnosis........................................................................................................................ 14-4
14.2.4 DCF Diagnosis ........................................................................................................................................... 14-5
14.3 Level Sense Diagnosis .............................................................................................................................................. 14-6
14.3.1 Introduction ................................................................................................................................................ 14-6
14.3.2 Level Sense Diagnosis ............................................................................................................................ 14-6
14.4 Dispersion Diagnosis ................................................................................................................................................ 14-8
14.4.1 Introduction ................................................................................................................................................ 14-8
14.4.2 Dispersion Dispense Volume Diagnosis ......................................................................................... 14-8
14.4.3 Dispersion Aspirating Volume Diagnosis....................................................................................... 14-8
14.5 Substrate Dispensing Diagnosis .........................................................................................................................14-10
14.5.1 Introduction ..............................................................................................................................................14-10
14.5.2 Substrate Dispensing Bubble Diagnosis .......................................................................................14-10
14.5.3 Substrate Dispensing Volume Diagnosis ......................................................................................14-11
14.6 Wash Buffer Dispensing Diagnosis ...................................................................................................................14-13
CL-1000i Chemiluminescence Immunoassay Analyzer XI

14.6.1 Introduction ..............................................................................................................................................14-13

14.6.2 Wash Buffer Dispensing Bubble Diagnosis(Inlet tube not empty).....................................14-13
14.6.3 Wash Buffer Dispensing Bubble Diagnosis(Inlet tube empty).............................................14-14
14.7 System Diagnosis......................................................................................................................................................14-15
14.7.1 Introduction ..............................................................................................................................................14-15
14.7.2 System Check ...........................................................................................................................................14-15
15 Maintenance···································································································15-1
15.1 Overview ........................................................................................................................................................................ 15-2

15.1.1 Introduction ................................................................................................................................................ 15-2
15.1.2 Maintenance Consumables .................................................................................................................. 15-2
15.1.3 Tools Required for Maintenance ........................................................................................................ 15-3
15.2 Maintenance Command........................................................................................................................................... 15-5
15.2.1 Introduction ................................................................................................................................................ 15-5
15.2.2 Maintenance Screen Overview ........................................................................................................... 15-5
15.3 Remote Help ................................................................................................................................................................. 15-7
15.3.1 Introduction ................................................................................................................................................ 15-7
15.3.2 Remote Diagnosis and Maintenance................................................................................................ 15-7
15.4 Cloud Web ...................................................................................................................................................................... 15-8
15.4.1 Introduction ................................................................................................................................................ 15-8
15.4.2 Cloud Web.................................................................................................................................................... 15-8
15.5 Scheduled Maintenance ........................................................................................................................................... 15-9
15.5.1 Introduction ................................................................................................................................................ 15-9
15.5.2 Maintenance Schedule ............................................................................................................................ 15-9
15.5.3 Scheduled Maintenance Procedures ................................................................................................. 15-9
15.5.4 Maintenance Log List ...........................................................................................................................15-10
15.5.5 Scheduled Maintenance Screen Overview ...................................................................................15-13
15.6 Daily Maintenance ...................................................................................................................................................15-16
15.6.1 Check Waste Tube/Tank Connection.............................................................................................15-16
15.6.2 Check Consumable Status ....................................................................................................................15-16
15.6.3 Check Syringe ..........................................................................................................................................15-17
15.6.4 Check Probe .............................................................................................................................................15-18
15.6.5 Clean Probe Exterior .............................................................................................................................15-20
15.6.6 Daily Clean .................................................................................................................................................15-22
15.6.7 Effect Check ..............................................................................................................................................15-23
15.7 Monthly Maintenance.............................................................................................................................................15-25
15.7.1 Clean Dust Screens.................................................................................................................................15-25
15.7.2 Clean Wash Wells ....................................................................................................................................15-26
15.7.3 Wipe Dispense Probes/Tubes ..........................................................................................................15-28
15.7.4 Clean Vortexer Hole ...............................................................................................................................15-29
15.8 Three-Month Maintenance ..................................................................................................................................15-31
15.8.1 Wash buffer bubble optical coupler calibration .........................................................................15-31
15.9 As-Needed/As-Required Maintenance ............................................................................................................15-32
15.9.1 Clean Analyzer Panels ...........................................................................................................................15-32
15.9.2 Clean Reagent Carousel .......................................................................................................................15-33
XII CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
15.9.3 Replace Syringe .......................................................................................................................................15-34

15.9.4 Clean Probe Interior..............................................................................................................................15-36
15.9.5 Replace Probe ..........................................................................................................................................15-39
15.9.6 Remove Air Bubbles in Syringe ........................................................................................................15-40
15.9.7 Bar Code Maintenance .........................................................................................................................15-42
15.9.8 Discard Cuvettes .....................................................................................................................................15-44
15.9.9 Fluidic Prime ............................................................................................................................................15-45
15.9.10 Clean the Cap of Wash Buffer Tank ..............................................................................................15-46
15.9.11 Clean Dispersion Aspirate Probes ................................................................................................15-47
16 Alarms and Troubleshooting ···············································································16-1
16.1 Classification of Logs ................................................................................................................................................. 16-2

16.1.1 Introduction ................................................................................................................................................ 16-2
16.1.2 Error Log ..................................................................................................................................................... 16-2
16.1.3 Edit Log ........................................................................................................................................................ 16-3
16.2 Viewing and Handling Logs ................................................................................................................................... 16-4
16.2.1 Description of Error Log Screen ........................................................................................................ 16-4
16.2.2 Description of Edit Log Screen ........................................................................................................... 16-4
16.2.3 Recalling Logs ............................................................................................................................................ 16-5
16.2.4 Refreshing Logs ........................................................................................................................................ 16-6
16.2.5 Clearing Logs .............................................................................................................................................. 16-6
16.2.6 Printing Logs .............................................................................................................................................. 16-6
16.3 Error Troubleshooting .............................................................................................................................................. 16-7
16.3.1 Introduction ................................................................................................................................................ 16-7
16.3.2 Error Indications ...................................................................................................................................... 16-7
16.3.3 Identifying Instrument Errors............................................................................................................. 16-8
16.4 Data alarm ...................................................................................................................................................................... 16-9
16.4.1 Introduction ................................................................................................................................................ 16-9
16.4.2 Result Flags ...............................................................................................................................................16-11
16.5 Error Messages and Corrective Actions ..........................................................................................................16-20
17 Template Modifying Software ··············································································17-1
17.1 Main Screen .................................................................................................................................................................. 17-2

17.1.1 Main Screen ................................................................................................................................................ 17-2
17.1.2 File (F) ........................................................................................................................................................... 17-2
17.1.3 Edit (E) ......................................................................................................................................................... 17-5
17.1.4 View (V) ....................................................................................................................................................... 17-5
17.1.5 Insert (I)....................................................................................................................................................... 17-6
17.1.6 Format (M) ................................................................................................................................................. 17-7
17.1.7 Set(S) ............................................................................................................................................................. 17-8
17.1.8 Help (H) ........................................................................................................................................................ 17-9
17.2 Common Tools ...........................................................................................................................................................17-10
17.3 Draw Tools ...................................................................................................................................................................17-11
17.4 Property Window .....................................................................................................................................................17-13
17.4.1 Page .............................................................................................................................................................17-13
CL-1000i Chemiluminescence Immunoassay Analyzer XIII

17.4.2 Line ..............................................................................................................................................................17-13

17.4.3 Rectangle ....................................................................................................................................................17-14
17.4.4 Label ............................................................................................................................................................17-15
17.4.5 Text ..............................................................................................................................................................17-17
17.4.6 Title ..............................................................................................................................................................17-18
17.4.7 Image...........................................................................................................................................................17-19
17.5 Report Window .........................................................................................................................................................17-21
Vocabulary ············································································································· 1
Index ···················································································································· 1
XIV CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
1 System Description
This chapter describes the system from the installation, hardware, software and
specifications perspectives, including:
 Installation requirements and methods of the instrument
 Hardware components
 Optional modules that can be configured with the instrument
 Introduction and operation of software screens
 Technical specifications
CL-1000i Chemiluminescence Immunoassay Analyzer 1-1

Operator's Manual
1.1 Installation Requirements and Procedure

1.1.1 Installation Requirements
CAUTION
Install the instrument in a place meeting the requirements presented in this section;
otherwise, it will not perform as promised.
Installation Environment
 The system is for indoor use only.
 The bearing platform should be level (with gradient less than 1/200).
 The bearing platform should be able to support at least 250kg.
 The installation site should be well ventilated.
 The installation site should be free of dust.
 The installation side should not be in direct sun.
 The installation site should be kept away from a heat or draft source.
 The installation site should be free of corrosive gas and flammable gas.
 The bearing platform should be free of vibration.
 The installation site should be kept away from large noise and power supply
interference.
 Keep the system away from brush-type motors and electrical contact device that is
frequently switched on and off.
 Do not use such devices as mobile phones and radio transmitter near the system.
 The system should be installed in a place with altitude height between -400 to 4000
meters.
Power supply
 Connect the system to a power supply meeting the requirements specified in this
manual. For more information, refer to 1.5 System Specifications.
 The system is provided with a three-wire power cord, which has good grounding
performance.
 The system should be connected to a properly-grounded power socket.
WARNING
Make sure the power junction box is grounded correctly. Improper grounding may lead to
electric shock or equipment damage. Check if the power junction box outputs voltage
meeting the specified requirements and has a proper fuse installed.
Temperature and humidity

 Ambient Temperature: 15°C-30°C.
 Humidity: 35%RH-85%RH, without condensation.
1-2 CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
CAUTION
Operating the system in an environment other than the specified may lead to
unreliable test results. If the temperature or relative humidity does not meet the
above-mentioned requirements, use air-conditioning equipment.
Drainage
 Make sure that the outlet is no less than 50mm wide and no greater than 100mm
high, and the length of the waste tubing does not exceed 5 meters. If the waste tank is
used, the guide tube is no less than 2m.
 Check and empty the waste tank before and after running the tests if waste tank is
used to hold the waste liquid in case overflow occurs.
BIOHAZARD
Dispose of the waste liquid according to the local regulations.
Wear gloves and lab coat, if necessary, goggles.
CAUTION
The outlet tubes for liquid waste 1 and 2 must not be connected together but routed
separately. Waste outlet tubes for waste 1 and 2 must not be connected with the
waste tube of other instrument, otherwise the analyzer may be damaged due to the
back flow of the liquid waste.
CAUTION
When connecting the tubes, exercise caution to avoid folding or pressing them.
After installing the instrument, connect it with the fluidic components as instructed in the
figure below.

Operator's Manual
Figure 1.1 Fluidic connection diagram(Waste tank used)
Waste tank used
Analyzing unit 1.Wash buffer inlet——standard

2.Waste outlet 1 ——standard
4.Waste sensor——standard
Sensor
4 3 2 1 Standard module
Wash
Waste tank buffer
tank
Figure 1.2 Fluidic connection diagram(Waste sewer used)

Waste sewer used
1.Wash buffer inlet——standard

Analyzing unit 2.Waste outlet 1 ——standard
4.Waste sensor——standard
Sensor
4 3 2 1 Standard module
Wash
buffer
sewer tank
Waste produced by the analyzer is drained to the waste tank or to the sewer.
Space and accessibility requirements

Install the instrument according to the clearance requirements as shown in the figure
below.

Operator's Manual
Figure 1.3 System clearances
Wall
≥700
≥500 Operation ≥500

760
Analyzing Unit
unit
Front
≥500
1400
≥500
Unit:mm
Table 1.1 Recommended computer configuration

Item Description
CPU P4 2.6G above
Random access memory At least 4GB
(RAM)
Network adapter The computer is connected to the analyzer through a
network adapter. If you are going to connect the computer
with the LIS or Internet, you should prepare another
network adapter (Intel gigabit network adapter)
Serial port 3 or above
Hard disk 160GB
Operating system The operating system installed on the computer must be an
activated Microsoft Windows 8 64bit or Windows 10 64bit .
Screen display Set the screen resolution as 1280*1024 pixels.
properties
Other Network adapter and sound card with speaker must be
configured.
Recommended printer configuration

You are suggested to choose one of the following printers for use with the computer:
 Ink jet printer
 Laser printer
 Stylus printer
1.1.2 Installation Procedure
WARNING
The system should be installed only by technicians of or authorized by our company.

Operator's Manual
The system should be installed by technicians of or authorized by our company. Before

the technicians arrive, prepare a proper site to install the system.
Before installation
When you receive the package, check it carefully. If you find any signs of mishandling or
damage, file a claim immediately with our Customer Service Department or your local
distributor.
After opening the package, check the delivered goods against the packing list, and then
visually check the system appearance. If you find anything missing or damaged, alert our
Customer Service Department or your local distributor immediately.
System relocation
If you want to relocate your system, contact our Customer Service Department or your
local distributor.

Operator's Manual
1.2 Hardware Structure

1.2.1 System Overview
The chemiluminescence immunoassay analyzer consists of analyzing unit , operation unit,
output unit (printer, optional), accessories and consumables.
The analyzing unit is composed of sample handling system, reagent handling system,
sampling system, substrate system, optical measurement reaction system, dispersion
system, cuvette load and transportation system, reaction liquid mixing system, sample bar
code system(Optional), reagent bar code system(Optional).
The operation unit is composed of computer, displayer(touch screen and monitor
bracket can be optionally configured. ), handheld bar code reader and operating
software(Version: V00.02).
The output unit is a printer used to print out test results and other data.
Accessories and consumables: disposable cuvette and waste container
Figure 1.4 Overview
(1) (2)
(3)
(1)Analyzing unit (2) Monitor

(3)Monitor bracket

Operator's Manual
Figure 1.5 Over view
(7)
(9) (6)
(1) (8) (2) (3) (4) (5)
(1)Cuvette load and transport system (2) left door(position for loading cuvette)
(3) Rack feeding area (4) Substrate positions
(5)Reagent carousel (6) Syringe
(7)Probe (8)Gripper
(9)Dispersion carousel

Operator's Manual
Figure 1.6 Rear view
（1）
（2）
(1)Upper protective shield (2)Dust screen

Operator's Manual
1.2.2 Sample Handling System

Sample handling system, transfers samples to aspirate position of analyzing unit, and
retrieves racks afterwards. It consists of the following assemblies:
 Sample rack lanes
 Sample transportation part
 Handheld Bar code reader(standard), fixed bar code reader (Optional)
 Sample rack
Sample rack lanes

Sample rack lanes are used to hold the sample rack for test and rerun. It can accommodate
up to 6 racks, and 10 sample positions are available on each rack. The racks are marked
as 1 to 6 from left to right and No. 6 is for STAT test by default.
Figure 1.7 Sample load area
(1) (2)
(1)Lanes holding the sample racks (2)Indicator for sample rack status
Sample transportation part

It includes the slots and the drive assembly. It can move in X, Y and Z direction to
transport the sample to different working positions: rack lanes--bar code scanning
lane-aspirate position-rack lanes.
Bar code scanning channel

When a rack is passing through the scanning channel, the bar code reader automatically
scans the bar code on the rack and sample cups to identify the rack type, rack ID and
sample information.
Sample rack indicator

The sample rack indicators on each channel is used to instruct the operations of loading
or unloading the sample racks. The sample rack status is indicated as follows:

Operator's Manual
Load sample
rack Green
Off
Click Start
Remove sample or sample delivery
rack starts
Sampling completed or
Flashing green Auto rerun completed yellow
When the indicator turns into yellow, do not perform any operations on this lane
otherwise the analyzer gives an alarm. When the indicator is flashing, please remove the
sample rack on this lane.
Sample rack
There are 10 sample positions on each rack
CAUTION
Do not disinfect the racks at high temperature (over 80°C) or by using strong acid or
alkaline; otherwise, the racks may be damaged.
Sample tubes varying in specification requires different minimum sample volumes. Each
sample tube must contain the minimum amount of sample; otherwise, correct aspirating
cannot be ensured. The minimum sample volume is the sum of the sample volume for
analysis (sum of defined sample volume for chemistry and the excessive aspiration 5μl)
and the dead volume of the sample container.
The table below shows the dead volume of each type of sample container.
Table 1.2 Specification and dead volume of sample containers
Sample Specification Dead Volume
Container
Microtube Φ14×25mm, 0.5ml (Beckman) 50μl
Φ14×25mm, 2ml (Beckman) 150μl

Φ12×37mm, 2ml (Hitachi) 100μl
Primary Φ12×68.5 mm 8mm more over the
tube/Plastic Φ12×99 mm unacceptable sample level
tube height
Φ12.7×75 mm
Φ12.7×100 mm
Φ13×75mm
Φ13×95 mm
Φ13×100 mm
Φ16X 75mm

Operator's Manual
Sample Specification Dead Volume

Container
Φ16X 100mm
1.2.3 Reagent Handling System

The reagent handling system is used to hold reagents and provides them for reacting with
samples. It is used to provide reagents, and send reagent to aspirate position for reaction
with samples in the cuvette. The optical measurement reaction system analyzes
programmed chemistry parameters of reaction liquid. It consists of the following
assemblies:
 Reagent carousel assembly
 Reagentload button
 Reagent bar code reader
 Reagent pack
Reagent carousel assembly

The reagent carousel is a turntable located on left side of the analyzer panel. It holds
reagent bottles and carries each of them to the reagent aspirate position for aspirating.
Reagent carousel contains 25 reagent positions, supporting bar code scanning as well as
magnetic bead reagent rotating and mixing.
The reagent carousel provides a refrigerating environment which is constant within
2°C-8°C for 24 hours a day. The reagents stored in such environment can be kept stable.
Figure 1.8 Reagent Carousel
(1)
(3)
(2)
(1) Reagent carousel cover (2) Reagent carousel

(3) Reagent load button

Operator's Manual
The reagent carousel cover consists of two parts. Open the front part of reagent carousel
cover by rotating the handle counter clockwise to load or change reagents.
CAUTION
Every day before analysis, remove the plugs on the reagent carousel in order to prevent
mechanical reset failure and bending reagent probe. After finishing the tests every day,
insert the plugs on the reagent carousel.
Ensure that the reagent carousel is closed while the system is analysing. Opening the
reagent carousel cover during analysing will abort the analysis and invalidate the tests
that are running.
If reagent is sprayed on the position numbers of the reagent carousel, clean it
immediately with ethanol-dipped gauze.
Reagent load button

The reagentload button located on the lower-right corner of the reagent carousel is used
to rotate the reagent carousel. When the reagent load button is pressed and held, the
reagent carousel starts rotating continuously until the button is released.
The button works only when the reagent carousel is opened.
The reagent load button has three statuses:
 Flashing: indicates that the reagent carousel is open and needs to be closed or that
the countdown when you request a stop for adding reagent is up and at this moment,
you can open the reagent carousel cover to load the reagent.
 On: indicates that the reagent carousel is in use and must not be opened; otherwise,
error may occur.
 Off: indicates that the reagent carousel is not in use and can be opened.
Reagent bar code reader

The reagent bar code reader located on the lower-right inside the reagent carousel
consists of the following components:
 Reagent bar code reader
 Bar code label
 Hardware and software to control bar code scanning
When the reagent carousel cover is closed after reagent bottles are loaded, the system
scans automatically all reagent positions to read reagent information and then displays it
on the screen.
Reagent bottle
The reagent pack is a single ready-to-use unit that consists of 4 bottles.
Routine Reagent Pack Specification:
 4 bottles
 50 tests/pack and 100 tests/pack
 Puncture reagent bottle

Operator's Manual
Figure 1.9 Reagent pack
(1) (2)
(1)) Magnetic bead reagent (2) Buffer, sample processing fluid and enzyme
labeled reagent
Reagent mixing
Reagent bottle is mixed by gear rotation, which uses the two fins inside the bottle for
mixing.
NOTE
Before loading reagents, manually rotate the gear below the magnetic bead bottle or
shake the reagent pack by following the requirements in reagent specifications for
mixing.
1.2.4 Sampling System

Sampling system is for dispensing samples and reagents, as well as washing probe.
Sample/reagent dispenser assembly

The sample/reagent dispenser assembly located on the front left side of the instrument, is
composed of the probe, probe arm, drive assembly, syringe and related tubing. It
aspirates the specified amount of sample and reagent and then dispenses it into a cuvette
for reaction and analysis.

Operator's Manual
Figure 1.10 Sample/reagent dispenser assembly
(1)
(2) (3)
(1)Probe (3)Probe drive assembly

(2) Wash well
Probe
There is one probe for the system, with sample aspirating volume of 10μl～200μL and
regent aspirating volume 20~200μL, 1μL of increment
Up to 3 reagents can be added for one step method, 4 reagents for two step method.
The reagent volume for each reagent is as follows:
 Ra (magnetic bead): 25μl～50μl, 1μl of increment.
 Rb: 20μl-135μl, 1μL of increment.
 Rc: 25μl-50μl, 1μL of increment.
 Rd: 25μl-50μl, 1μL of increment
The probe is capable not only of aspirating sample and reagent but also of the following
functions:
 Clog detection: checks the probe for blockage. When detecting blockage, the system
produces a warning and wash the probe automatically.
 Horizontal obstruct detection: detects obstacles in the horizontal direction. When the
probe collides with an obstacle in the horizontal direction, the auto guard system is
started to prevent the probe from being damaged.
 Vertical obstruct detection: detects obstacles in the vertical direction. When the probe
collides with an obstacle in the vertical direction, the auto guard system is started to
prevent the probe from being damaged.
 Level detection: detects the sample and reagent level.

Operator's Manual
WARNING
When the system is in operation, do not place any part of your body or any obstacle in
the route where the probe arm moves; otherwise, personal injury or equipment damage
may be caused.
Probe washing
Wash buffer is used for probe interior and exterior washing.
Probe concentrated wash solution is placed in concentrated wash solution position on the
panel.
Syringe
The syringe is located at the rear of the analyzing unit.
Figure 1.11 Sample Syringe
(1)
(1) Syringe
1.2.5 Substrate System

The substrate system dispenses and preheats substrate: dispensing preheated substrate
into cuvette in which dispersion is completed through the dispensing port on dispersion
carousel; conducting optical measurement after substrate being incubated on dispersion
carousel and reaction carousel. Substrate system is composed of substrate bottle,
substrate dispensing module and substrate preheating module.

Operator's Manual
Figure 1.12 Substrate System
(1) (2)
(1) Substrate 1 (2) Substrate 2
Substrate bottle
Substrate bottle holding substrate for chemiluminescence measurement is located on the
right front part of the work station panel. Up to 2 substrate bottles can be placed side by
side.
Figure 1.13 Substrate bottle
NOTE
To make sure that substrate has reached complete equilibration before use, it should
have been equilibrated at the room temperature for above 6 hours.
Substrate bottles are used in turns. When one bottle is used up, the system will
automatically switch to the other and prompt you to replace in time.
Each bottle of substrate can support 500 or 300 tests. Substrate can be manually loaded.
Information such as lot No., expiration date and so on can be obtained by hand-held bar
code reader.

Operator's Manual
Substrate status button

Two substrate status buttons located on the panel in front of substrate bottles are
corresponding to the two bottles. After changing the substrate, press corresponding
button so that the system can automatically refresh substrate status.
Table 1.3 Substrate status button
(1) (2)
(1) Substrate Status Button 1 (2) Substrate Status Button 2

In addition to refreshing substrate status, the button also indicates status of the substrate
bottles and instructs operation.
When instrument default mode is enabled, the two substrate bottles are used in turns and
the indication light status are as follows:
 On: Substrate is being used, not allowing changing.
 Flashing: Substrate is expired or exhausted, changing is needed.
 Off: Substrate is full and for standby use, changing is not needed.
If only one bottle of substrate is configured, the indication light status is as follows:
 On: Substrate is being used, not allowing changing.
 Flashing: Substrate is expired or exhausted, changing is needed.
 Off: The substrate bottle is unloaded.
Substrate dispensing module

The substrate dispensing module is located in the lower right part of analyzing unit. It
punctures through the rubber plug at the bottom of substrate bottle, aspirates substrate,
and dispenses into cuvette on dispersion carousel for reaction and optical measurement.
Substrate dispensing volume is 200μl.
Substrate Preheating Module

The substrate preheating module is located under dispersion unit, and preheats substrate
before it is dispensed into cuvette for reaction.

Operator's Manual
1.2.6 Optical Measurement Reaction system

Optical measurement reaction system is composed of reaction carousel assembly and
photometer module. It holds reaction cuvettes and provides an appropriate and steady
environment for reaction liquid, which is transmitted to the photometric position for
signal collecting and calculating light intensity.
Reaction carousel assembly

The reaction carousel is a turntable carousel located in the left rear of the analyzer panel.
Reaction carousel is composed of 3 rings (inner, middle and outer), with each ring
holding 25 cuvettes, and 75 cuvette positions in total. The inner and middle rings are used
for sample and reagent incubation, and the outer ring is for reagent dispensing, substrate
incubation and optical measurement.
The reaction carousel is capable of temperature control and provides a constant
environment at 37±0.3°C with fluctuation of ±0.2°C.
Figure 1.14 Reaction Carousel
(2)
(1)
(1) Reaction carousel (2)Cuvette buffer area

The cuvettes are disposable plastic cups, used for carrying reaction liquid for incubation
and optical measurement.
The system automatically unloads cuvettes and throws them into cuvette waste container
upon test completion.
Photometer module
The photometer module is composed of photon counting module and reference module.
The photon counting module detects light intensity of the liquid to be measured, and
calculates the analyte concentration by calibration curve.
The reference module provides steady light output for the calibration of the photon
counting module, and evaluates counting stability and repeatability during photometer
diagnosis process.

Operator's Manual
The measurement wavelength is 500nm～600nm.
1.2.7 Dispersion System

The system supports 4-phase dispersion. When the incubation reaction of sample and
magnetic bead reagent is completed, it separates the sample-reagent analyte that has
been bound with beads from the liquid phase by wash buffer. The dispersion system is
composed of dispersion carousel and dispersion unit.
Cuvettes pass through the aspirating and dispensing unit of each dispersion phase to
complete dispensing, aspirating and dispersion.
Figure 1.15 Dispersion System
(1)
(1) Dispersion System

The dispersion system utilizes wash buffer for reaction mixture 4-phase dispersion in
order to separate the magnet-bound complexes from the reaction liquid. The 4-phase
dispersion procedure is as follows:
 Phase 1 wash: Add wash buffer, disperse and aspirate
 Phase 2, 3 and 4 wash: Add wash buffer, rotate and mix, disperse and aspirate
Dispersion carousel temperature is 37±0.3℃, with fluctuation of ±0.2℃.
1.2.8 Cuvette Load and Transport System

The cuvette load and transport system, located in the left front of the analyzer, completes
the procedure of loading, transporting and disposing the disposable cuvettes.
In the left front of the analyzer, there are two cuvette tray load drawers. Place the cuvette
tray on the drawer and the gripper grips the cuvette to move among the sampling
position, mixing position, reaction carousel, dispersion carousel, cuvette disposal position
and finally discard it into solid waste container.

Operator's Manual
Figure 1.16 Cuvette Load and Transport System
(1)
(1) Cuvette Load and Transport System

Cuvettes are placed on the tray and manually loaded to feeding area. 2 trays can be loaded
at one time, with each tray holding 88 cuvettes (11*8), i.e., total 176 cuvettes can be
loaded every time.
Load or take out cuvette tray according to the tray status indication light on the front
panel:
 On: The unit is working. Do not pull out the drawer.
 Flashing: There is no cuvette on the tray or you have selected the cuvette tray to load
cuvette on the screen or the cuvette tray have been taken away. You are required to
load new tray or take out old tray.
 Off: cuvette tray are not being used. Drawer can be pulled out. If cuvette tray 2 is
disabled, its indicator light is always off.
Gripper unit grips cuvettes and transports them among cuvette working position,
sampling position, dilution position, cuvette discarding position and reaction carousel.
The gripper is capable of 3D straight line motion and bump detection.
Solid Waste Container

The solid waste container collects used cuvette from cuvette disposal ports on the panel. It
holds at least 200 cuvettes.

Operator's Manual
Figure 1.17 Solid Waste Disposal Unit
(1) (2) (3)
(1)Cuvette drawer 1 (2) Cuvette drawer 2

(3) waste container
Empty the container according to the indicator light of the waste container:
 Flashing: The container is full; need to empty it. Or the container is taken away; need
to load it .
 Off: The container is not full. Emptying is allowed.
 On: The container is in use.
After emptying the container, press the indicator light button to confirm the procedure.
1.2.9 Reaction Liquid Mixing System

The reaction liquid mixing system mixes reaction mixtures in various procedures with a
vortexer:
 Sample auto dilution: Mixing the sample with sample diluent.
 One step method: Mixing sample and reagent
 Two step with one dispersion: Mixing sample and first-step reagent, mixing the
reaction mixture and second-step reagent
 Two step with two dispersions: Mixing sample and first-step reagent, mixing the
magnet particle complexes and second-step reagent
A vortexer is capable of rotational speed detection.

Operator's Manual
Figure 1.18 Reaction Liquid Mixing System
(3)
(1) (2)
(1) Diluting sample Position (2)Dispensing and mixing sample

position
(3)Reaction carousel
1.2.10 Operation unit

The operation unit is a computer configured with chemiluminescence analyzer
operating software. It consists of the monitor, computer, keyboard, mouse and handheld
bar code reader.
1.2.11 Output Unit

The output unit is a printer used to print out test results and other data. The system
supports three types of printer, which include inkjet printer, laser printer and stylus
printer.
Printer is an optional module and not provided when the system is sold. If you want to
buy our printer, please contact our customer service department. If you want to buy a
printer of other manufacturers, please choose one meeting the requirements.
1.2.12 Accessories and Consumables

Accessories and consumables are replenishable components required to run tests and
should be checked regularly for refilling and replacement.
CAUTION
Use the accessories, power cords and consumables manufactured or recommended by
our company in order to achieve the promised system performance and safety. If needed,
contact our customer service department or your local distributor.
For more information about accessories and consumables, refer to "15.1.2 Maintenance
Co"(15-2 page).

Operator's Manual
1.3 Optional Modules
1.3 Optional Modules

1.3.1 Introduction
Optional modules are not provided as standard configuration accompanying the
instrument when it is delivered. They can be configured according to your requirements.
The following modules are supplied:
 Touch screen monitor
 Printer
 Monitor bracket
 Built-in sample bar code reader
 Built-in reagent bar code reader
1.3.2 Touch screen monitor

The standard configuration for the analyzer is common LED monitor. Touch screen
monitor can be optionally configured. If you want to configure a touch screen monitor,
1.3.3 Monitor bracket

It is used to hold the monitor. If you want to configure it, contact our customer service
department or your local distributor.
1.3.4 Printer
Printer used to print test results and other data. The system supports three types of
printer, which include inkjet printer, laser printer and stylus printer.
Printer is an optional module and not provided when the system is sold. If you want to
buy our printer, please contact our customer service department. If you want to buy a
printer of other manufacturers, please choose one meeting the requirements.
1.3.5 Built-in sample bar code reader

It is used to scan the bar code of the sample and sample rack . If you want to configure it
1.3.6 Built-in Reagent bar code reader

It is used to scan the bar code of the reagent . If you want to configure it contact our
customer service department or your local distributor.
1.3.7 Other Optional Modules

For more information about other optional modules, contact our customer service

Operator's Manual
1.4 Software Description

1.4.1 Main Screen
Figure 1.19 Main screen
(5)
(1)
(2) (4)
(3)
(1) Status display area (4) Function window

(2) Function buttons area (5) Shortcut icons area
(3) Prompt message area
Status display area

The status display area shows the status of the entire system, including: chemistry test
status, system date/time, LIS connection, printer, login user and module status.
Table 1.4 Status display area
Status Description
Status This indicator appears on the left of the status display area and
shows general status of the analyzer.
It includes: Initializing, Incubation, Reagent load, Auto Mixing,
Restoring, Stopped, Shutdown, Standby, Running, Maintenance
and Diagnosis.
Analyzing time This indicator appears in the middle of the first column of status
left display area. The time indicates how many minutes left the
analysis will be finished.

Operator's Manual
Status Description
Current system This indicator appears on the right of the status display area. It
time indicates the system date and time.
LIS status
This indicator appears on the left of the status display area. The
following information is indicated:
 If appears in blue, the LIS host is connected and online.
 If appears in grey, the LIS host is offline.

Printer status
This indicator appears on the left of the status display area. It
indicates the status of the printer: not printing and printing.
 If the icon appears in grey, the printer is not performing print
tasks or unconnected.
 If the icon appears in blue, the printer is printing.
Login user This indicator appears in the middle of the status display area. It
indicates the user who logs in the system.
Function buttons area

The function buttons area contains the following buttons used to access various function
windows of the system:
 : used to program patient samples and control samples, and view sample rack
status.
 : used to recall test results of patient samples and controls, the result
statistics , test statistics , charge statistics and abnormal samples.
 : used to load reagents, define/edit calibrators, request calibrations, recall

calibration results, and view the status of the consumables.
 : used to define/edit controls and rules, recall QC results and summary.
 : used to set up chemistry and system parameters, perform system

maintenance and diagnosis, and view component status.
 : used to recall and handle error logs and delete/edit logs.
 : used to log off and exit the system.

Operator's Manual
Prompt message area

The prompt message area contains two lines, the upper line displaying operation
prompts for screen controls and the lower line displaying error messages.
Function window
The function window contains options, buttons and other controls used to perform
various functions of the system.
Shortcut icons area

The shortcut buttons area contains the following icons used to quickly access certain
function window or perform an operation:
 : Start icon. Select it to display the Start Conditions dialog box, in which you are
allowed to start new analysis or resume early testing.
 : Rack Stop icon. It is used to stop transmission of sample racks. When this icon
is selected, the system stops delivering racks. Those racks that have been carried to
the lanes will continue with the analysis until all tests are finished. When rack
transfer is stopped, you are allowed to load sample racks or replenish samples.
 : Emergency stop icon. Select it to stop all tests. All tests that are running will be
invalidated.
 : STAT icon. Select it to display the Program STAT Sample window, in which you
are enabled to program emergency samples quickly.
 : Online help icon. Select it to display the online help of the current window,
where you will find description of parameters and operations.
1.4.2 Function Icons and Program Structure

On the left and top of the main screen, several buttons are designed providing access to
each of the major functional areas of the system. The overall program structure is shown
on the following pages.

Operator's Manual
Figure 1.20 Program structure (Samples)

Restore F3
Prev F4
Demog F1 Next F5
Sample
Options F2 Discard F6
Save F7
Exit F8
Batch F3
OK
Cancel
Search F1 All Programmed Samples

Release F4 All Latest Samples
Unpositioned F2
Download F3 Sample(s)with Following
ID(s)
List F5 Sample List Sample with Following
Refresh F5
Clear F6 Bar Code
Print F7 OK
Prev F6 Cancel
Exit F8
Next F7
Save F8 Chemistry List Download F3
Clear F6
Print F7
Quality Select Rgt F3 Exit F8
Control Prev F4
Next F5
Discard F7
Save F8
Rack Search F1
Status Result F2

Operator's Manual
Figure 1.21 Program Structure (Results)

By sample Search F1
Current Options F2
By chemistry
Delete Results
Recall Rerun Results
Customize Result Display
Restore F3 Print Multi-sample Report
Prev F4 Archive
Demog F3 Next F5 Recalculate
Discard F6 Compensate
Save F7 Result Trend
Exit F8 Close
Reaction Data Prev F4
F4 Next F5
Rerun F5 Print F7
Review F6 Exit F8
Print F7
Host F8
By sample Delete Results
History Search F1
By chemistry
Recall Rerun Results
Options F2
Customize Result Display
Print Multi-sample Report
Archive
Restore F3
Recalculate
Prev F4
Compensate
Next F5
Result Trend
Demog F3 Discard F6
Close
Save F7
Exit F8 Prev F4
Reaction Data Next F5
F4 Print F7
Rerun F5 Exit F8
Review F6
Print F7
Host F8 By Sample
By Test
Tests Search F1
Print F7
Statistics
Results Statistic Graph
Statistic Data
Search F1 Search F1
Charges Print F7
Charge setup F2
Rerun F5
Abnormal status
Abnormal
Batch Rerun F6
Rerun status

Operator's Manual
Figure 1.22 Program structure (Reagent)
Prev F1
Load F1 Next F2
Reagent/Calibration Reagent Stop F2 Load F3
Load List F4 Unload F4
Cal F5 Exit F5
No Cal F6 Extend Calibration Time
Print F7 Reject OK
Cal Options F8 Individual bottle calibration Caneel
Prev F1
Consumable Load F1 Next F2
Management Load F3
Print F7 Unload F4
Search F1 Exit F5
Cal Data F2 Prev F4
Calibration Archive F5 Next F5
Result
Print F7
Exit F8
Trend F6 Search F1
Print F7 Prev F4
Prev F1 Next F5
Next F2 Exit F8
Manual Load F1 Load F3
Unload F4
Reagent Exit F5 Up
v
Overview Reagent F3
Down
Close
Print F7
Define F1
Master Curve F3
Cal Setup
v
Delete F6
Sample Cup F5
Cal Position Discard F7
Save F8

Operator's Manual
Figure 1.23 Program Structure (QC)
Search F1
Chart F3 QC Time(yymmddhhmmss)
Prev F4 QC Date(mmdd)
Levey-Jennings
Next F5
Delete F6
Print F7
Comment F8
Twin-Plot Search F1
Prev F4
Next F5
Print F7
Results
Search F1
Chems F2 Prev F5
Reac Data F4 Next F6
Comment F5 Print F7
Archive F6 Exit F8
Print F7
Search F1
Summary Chems F2
Print F7
Define F1 Select All
QC Setup Chems F2 Clear
Rules F3 OK
Import Control F4 Save Cancel
Delete F6 Cancel
Discard F7 Close
Save F8
Control Sample Cup F5
Position Discard F7
Save F8

Operator's Manual
Figure 1.24 Program structure (Utilities, 1/3)
Qualitative F3
Chemistries Prev F4
Define F1
Next F5
Import F2 Mask/unmask chemistries
Discard F6
Save F7 Chemistry configuration
Close F8 Display order
Version Info
Options F3 Delete
Exit
Ref Range F1
Options F2
Delete
Ref Range F4 Reflex F3
Default
Prev F4
Next F5
Discard F6
Save F7
Exit F8
Slope/Offset F5 Restore Defaults

Save
Discard
Close
Flag Qualitative Results
Calculations F6 Define F1 OK
Delete F2 Cancel
Print F7
Close F8 Define
F1 1. Auto Startup Setup
Panels F7
Delete 2. Dictionary
F2 3. Com Setup
Up F3 4. Language
Down F4 5. Auto Maintenance Setup
Print F7 6. Version Info
Close F8 7. Date/Time
8. Auto Release Sample
9. Voice Tone Setup
10. Optimize Result
Display
System Setup Instrument F1 11. Cust. Sample Info.
12. Patient Demographics
13. Customize Reagent
Display
14. Analysis Mode
15. Consumable alarm
limit
16. Disable cuvette tray
17.STAT lane setup
Set Defaults 18. Substrate air bubble
Delete detection setup
Edit 19 Consumable check
Print F3 Import before test
Print Order 20 Remote Help
OK Exit
Cancel
Auto Number Scanned Samples
Bar code F4 Sample Bar Code OK
OK Cancel
Cancel
Restore Defaults
Host F5 Advanced
User F6 New Connect
Discard F7 Modify Save
Save F8 Delete Close
Permission
Exit

Operator's Manual
Check Syringes
Check Probe
Scheduled Daily Clean
Maintenance Daily Check Waste Tank Connection
Maintenance Maintenance
Check Consumable Status
(Continued) Effect Check
Clean Probe Exterior
Clean Dispersion Aspirate Probe
Exterior
Select All
OK
Weekly Replace/Clean Aspirate Probes Log
History
Customize
Delete
Clean Dust Screens Close
Wipe Dispense Probes/Tubes
Monthly
Clean wash well
Clean Vortexer Hole
Three-Month
Wash buffer bubble detection
coupler calibration
Other Clean Analyzer Panels

Clean Reagent Carousel
Clean Probe Interior
Maintenance Replace Probe
Commnad Home
Remove Air Bubbles in Syringe
Clean Probe Exterior
Bar Code Maintenance
Clean Probe Interior
Discard Cuvettes
Clean/Replace Probes
Fluidic prime
Syringe Maintenance
Replace Syringe
Clean Vortexer
Clean the cap of wash buffer tank
Clean Dispersion Probe/Tubes
Discard Cuvettes
Fluidic Prime
Effect Check
Daily Clean
Sensor Calibration

Operator's Manual

Dark Current Count
Photometer Diagnosis Diagnosis
Maintenance Diagnosis Photon Count Diagnosis
DCF Diagnosis
(continued)
Level Sense Diagnosis Level Sense Diagnosis
Dispersion Dispense Volume Diagnosis
Dispersion Diagnosis Dispersion Aspirate Flow Diagnosis
Substrate Dispensing Substrate Dispensing Volume

Diagnosis Substrate Dispensing Bubble Diagnosis
Wash buffer dispensing bubble

Diagnosis(Inlet tube not empty)
Wash buffer dispensing
Wash buffer dispensing bubble
Diagnosis
Diagnosis(Inlet tube empty)
Status Summary System Check
System Diagnosis
Status Temperature
Power
Hydro Print F7
Smart Modules
Figure 1.27 Program structure (Alarms, Exit and STAT)

Search F1
Error Log
Refresh F2
Delete F3
Diagnostics F6
Print F7
Edit Log Search F1
Refresh F2
Delete F3
Print F7
Log off
Shut Down
OK
Cancel
Restore F3
Demog F1 Prev F4
Next F5
STAT Discard F6
Save F7
Exit F8
Options F2
Chems F3 Set Defaulsts F3
Save F7 Save F7
Close F8 Close F8
1.4.3 Using a Mouse

Move
The mouse is presented on the screen in the form of pointer. Place the mouse on a flat
platform, and then move it to make the pointer lap over the object that you want to select
or edit.

Operator's Manual
Select
Move the mouse to make the pointer lap over the object that you want to select or edit,
and then press the left mouse button and release it quickly. Pressing the left mouse button
is functionally equivalent to touching the screen.
Double-click
Move the mouse to make the pointer lap over the object that you want to select or edit,
and then quickly press the left mouse button twice and release it. Pressing the left mouse
button twice is functionally equivalent to touching the screen twice.
Drag
Dragging is used to move the slider on a screen in order to choose a scale. Move the
mouse to make it stop over the slider, press and hold the left mouse button, move the
mouse left and right to adjust the slider to the desired scale.
Using a mouse in conjunction with a keyboard

Some lists on the screen allow you to select more than one object at one time, and you can
achieve this by using a mouse in conjunction with a keyboard. When selected, the objects
will be highlighted for easy identification.
Perform the following operations to select more than one object:
 To select discontinuous objects, press the left mouse button to select the first object,
press and hold the Ctrl key, use the mouse to select other desired objects, and then
release the Ctrl key.
 To select continuous objects, press the left mouse button to select the first object,
press and hold the Shift key, use the mouse to select the last object, and then release
the Shift key.
1.4.4 Using a Touchscreen

The system supports a touchscreen, by using which you are allowed to perform various
operations of measurement. The touchscreen can be operated in the following ways:
Move
Put your finger above the mouse pointer, and then move your finger to make the pointer
stop at the object that you want to select or edit.
Select
Move your finger to make the pointer lap over the object that you want to select or edit,
touch the screen and then release it quickly. Touching the screen is functionally
equivalent to pressing the left mouse button.
Double-click
Move your finger to make the pointer lap over the object that you want to select or edit,
quickly touch the screen twice and then release it. Quickly touching the screen twice is
functionally equivalent to pressing the left mouse button twice.

Operator's Manual
Drag
Dragging is used to move the slider on a screen in order to choose a scale. Move the
mouse pointer to make it stop over the slider, press and hold the screen, and then move
the pointer left and right to adjust the slider to the desired scale.
Using a touchscreen in conjunction with a keyboard

Some lists on the screen allow you to select more than one object at one time, and you can
achieve this by using a touchscreen in conjunction with a keyboard. When selected, the
objects will be highlighted for easy identification.
Perform the following operations to select more than one object:
 To select discontinuous objects, touch the screen to select the first object, press and
hold the Ctrl key, touch the screen again to select other desired objects, and then
release the Ctrl key.
 To select continuous objects, touch the screen to select the first object, press and hold
the Shift key, touch the screen again to select the last object you desire, and then
release the Shift key.
1.4.5 Using Online Help

The system provides you with help information about the screens. If you do not
understand a parameter or an operation on a screen, you can go to the online help for
relevant information.
Accessing the online help

 Access the online help from any screens by selecting the icon to display the help
topic related to the current screen.
 Press the shortcut combination key Alt+F1 to display the topics related to the
current screen or window.
Viewing screen information

The online help document contains descriptions of parameters, operations, maintenance
and troubleshooting of the operating software. To view the information related to the
current screen or window, perform the following steps.
1 Access the online help in the following ways:
 Select the button on the upper right corner of the main screen, or press the
shortcut combination key Alt+F1.
 To perform maintenance operations, select the icon in front of the desired

maintenance procedure.
 To view details of an error log, select the icon in front of the error log.
 To view details of an alarm message, select the icon on a warning or error

message window.
2 Read the help topics. Move the scroll bar on the right side of the help window to view
more information.
3 Select to close the help window.

Operator's Manual
Viewing other information

To view other information in the online help,
1 Select the icon on the upper right corner of the main screen, or press the
shortcut combination key Alt+F1.
2 Select the following tabs to view relevant information:
 Contents: to navigate through all topics of the online help.
 Index: to view topics related to the input keywords.
 Search: to view topics containing the input keywords.
 Bookmarks: to view your favorite topics.
3 Read the help topics. Move the scroll bar on the right side of the help window to view
more information.
4 Select to close the help window.

Operator's Manual
1.5 System Specifications

1.5.1 Technical specifications
Throughput and reaction type
Table 1.5 Throughput and reaction type
Parameter Description
Throughput Up to 120 tests/hour
Analysis Mode 1. One step format
2. Two step format with one dispersion
3. Two step format with two dispersions
Support auto sample dilution
Principles of analysis Sandwich and Competitive Method
Reagent Management Mindray Closed Reagent Management
Sample handling system

Table 1.6 Specifications of the rack feeder system
Composition Composed of sample rack lanes, sample transfer part,
sample bar code reader and sample rack
Sample rack lanes used to load and unload sample racks.
Sample transfer part Composed of the track and drive assembly. It can
transfer samples in X, Y and Z direction among the
different working positions.
Sample rack 10 sample positions are available on each rack.
Sample capacity Each rack provides 10 sample positions, and maximum
of 6 racks can be accommodated in the sample load
area. Therefore, up to 60 samples can be held
simultaneously.
Sample Container Support micro tube, primary tube or plastic tube.
Sample Load Racks can be loaded or unloaded conveniently, and
batch load/unload is supported. Samples and
chemistries can be added during analysis. Priority of
emergency samples and auto rerun are supported.
Sample volume 10μl-200μl,with 1μL increment
Bar Code Scanning The bar code reader can be optionally configured and
used to scan bar code of racks and samples. The rack
bar code is defined by the manufacturer, and the
sample bar code can be set up by users.
Reagent handling system

Table 1.7 Specifications of the reagent handling system

Operator's Manual
Reagent Carousel One reagent carousel holds 25 reagent positions, with
magnetic bead reagent mixing function.
Reagent Pack Supporting 100 test/pack and 50 test/pack
Supporting up to 4 reagents: Ra, Rb, Rc and Rd.
Reagent volume 20μl-200μl, increment of 1μl.
Reagent refrigeration Constant refrigeration for 24 hours.
Reagent Management Closed reagent management, supporting built-in reagent
bar code scanning.
Sampling system
Table 1.8 Specifications of the sampling system
Sample volume 10μl-200μl, increment of 1μl
Probe One probe available, featuring level detection,
horizontal/vertical bump detection and clog
detection.
Auto sample dilution Supporting auto sample dilution with dilution ratio of
1:2～1:40.
Reagent volume 20μl-200μl, increment of 1μl.
Probe washing Use wash buffer for probe interior and exterior
washing.
Substrate system
Table 1.9 Specifications of the substrate system
Tests available for each 500 or 300 tests
substrate bottle
Substrate Dispensing Volume 200μl
Substrate Preheating Supporting substrate preheating
Bar Code Scanning Supporting hand-held bar code scanning to input
substrate lot No., bottle No., expiration date and so
on.
Optical measurement reaction system

Table 1.10 Specifications of the reaction system
Optical Measurement Photon Counting
Signal detector Photomultiplier photon counter
Calibration optical source LED reference module
Measuring wavelength 500nm～600nm
Luminescence system Alkaline phosphatase label, enzymatic
chemiluminescence, glow

Operator's Manual
Reaction Carousel 75 positions available
Reaction temperature 37℃±0.3℃, fluctuation of ±0.2℃
Cuvettes Disposable plastic cuvettes
Dispersion system
Table 1.11 Specifications of the dispersion system
Dispersion Carousel Independent rotary dispersion carousel
Dispersion procedure 4-phase dispersion by wash buffer in dispersion unit
Dispersion Carousel 37±0.3℃, fluctuation of ±0.2℃
Temperature
Cuvette load and transport system

Table 1.12 Specifications of cuvette load and transport system
Number of cuvettes per load 176 pieces, loaded with entire tray
Solid Waste Container One solid waste containers are equipped to retrieve
used cuvette.
Reaction liquid mixing system

A vortexer is equipped with the function of rotational speed detection.
Wash buffer consumption

≤2.16L/hour
1.5.2 Power Supply Requirements

Table 1.13 Power supply requirements
Analyzer Parameter Description
Analyzer Power 110V:
110V/115V~, 60Hz
220V:
220V-240V~, 50Hz
220V/230V~, 60Hz
Voltage fluctuation ±10%
Input power ≤2000VA
1.5.3 Environmental Requirements

Operating environment
 Temperature: 15°C-30°C
 Humidity: 35%RH-85%RH, without condensation
 Altitude height: -400m-4000m

Operator's Manual
Storage environment
 Temperature:-10°C-50°C
 Humidity: 30%RH-85%RH, without condensation
 Atmospheric Pressure: 106kPa～50kPa
1.5.4 Dimensions and Weight

Analyzing Unit
 Dimension: 1400mm(length)×760mm(depth)×600mm(height)
 Weight: ≤250Kg
Single Rack
 Dimension: 200mm(length)×22mm(depth)×65mm(height)
 Weight: ≤100g
1.5.5 Input device

 Keyboard
 Mouse
 Display monitor(touch screen is optional)
 Bar code reader
 LIS: HL7 and ASTM1394 (communicating through the network interface or serial
port)
1.5.6 Output device

 Printer
 Display monitor
 LIS: HL7 and ASTM1394 (communicating through the network interface or serial
port)
1.5.7 Noise and Fuse

Table 1.14 Noise and fuse
Noise Working: ≤65dBA
Standby: ≤60dBA
Fuse 250V 13A
1.5.8 Communication Interface

Table 1.15 Communication interface
Communication interface Description
RS232 Serial port  Used for communication between the LIS or Data
Management Software and the operation unit
 Used for connecting the operation unit with a
printer

Operator's Manual
Communication interface Description

Network interface  Used for communication between the analyzing
and the operation unit
 Used for communication between the LIS or Data
Management Software and the operation unit
USB port  Used for connecting the operation unit with a
printer
 Used for connecting the operation unit with an
external storage device
 Used for connecting the operation unit with a
handheld bar code reader
1.5.9 Safety Classification

Table 1.16 Safety classification
Overvoltage type Class II
Pollution degree 2
Device type Fixed device
Work type Continuous
Degree of ingress protection Common device
1.5.10 EMC Requirements

This equipment complies with the emission and immunity requirements described in EN
61326-1:2013 and EN 61326-2-6:2013.

Operator's Manual
2 General Operating Procedure
This chapter illustrates the methods of using the instrument and the routine operating
procedure in clinical laboratories. The common steps include:
 Check before Powering On
 Powering on
 Checking System Status
 Loading Reagent
 Calibration
 Quality Control
 Programming routine samples
 Programming STAT samples
 Test status and emergency stop
 Daily maintenance
 Powering off and log off
 Check after powering off

Operator's Manual
2.1 General Operating Procedure
2.1 General Operating Procedure

Table 2.1 General Operating Procedure
Procedures Description Section
1. Check before powering Check if the following components are ready 2.2
on for analysis: wash buffer supply, probe wash
solution, cuvette inventory, substrate
inventory, power supply, printing paper,
waste tank or waste sewer connection,
probe and rack feeder system.
2. Powering on Switch on the analyzing unit and run the 2.3
operating software.
3. Checking system status Check the status of the consumables, 2.4
printer, LIS connection status, analyzing unit
status, alarms, reagent/calibration,
maintenance and subsystems.
4. Preparing reagents Prepare reagents, probe wash solution, 2.5
substrate and wash buffer; load cuvette and
empty the solid waste container.
5. Calibration Request calibrations, prepare calibrators 2.6
and run calibration tests.
6. Quality Control Program, prepare and run control samples. 2.7
7. Programming routine Program, prepare and run routine samples. 2.8
samples
8. Programming STAT Program, prepare and run emergent and 2.9
samples STAT samples
9. Test status and analysis View reagent status, as well as the running 2.10
control status of calibrators, control samples,
routine samples and STAT samples; view
rack status and reagent carousel status;
stop the analysis.
10. Daily maintenance Perform daily maintenance procedures 2.11
11. Powering off Switch off the power supply 2.12
12. Check after powering Restore the reagent carousel cover, take out 2.13
off the calibrators, controls and samples and
store them properly, clean the analyzer
panels, and empty the waste tank, solid
waste container.

Operator's Manual
2.2 Check before Powering On
2.2 Check before Powering On

2.2.1 Checking Power Supply
1 Check if the power supply is available and can provide correct voltage.
2 Check the connections among the operation unit and printer. Make sure the
connections are correct and secure. Check the power cords of the operation unit and
printer and make sure they are well connected to the power sockets.
2.2.2 Checking Printing Paper

Check if sufficient printing paper is prepared in the printer. If not, refill the printing
paper.
2.2.3 Check Waste Tank Connection

Liquid waste from the analyzer is drained through the waste tank and then disposed
according to relevant regulations, or directly drained to the sewer.
BIOHAZARD
While checking the waste tank and tubing, wear gloves and lab coat, if necessary,
goggles.
NOTE
The analyzer drains 3.1L of liquid waste per hour.
1 Check if the waste tank has been emptied. If not, empty it.
2 Check waste tank connection to make sure that the waste tubing is not bent and the
sewer opening is lower than the waste outlet of the system.
2.2.4 Checking Probes

The probe is easy to be polluted or damaged. Check it carefully for dirt and bend before
powering on the system.
Check probe for dirt and, bend
 If it is polluted, clean it.
 If it is bent, replace it.
2.2.5 Checking Rack Feeder System

Check the rack lanes and sample track to ensure they are normal.
Check the lanes, for racks and dirt.
2.2.6 Checking Cuvette, Wash Buffer, Substrate and Probe Wash Solution
Check if the cuvette, wash buffer, substrate and probe wash solution are sufficient. If not,
refill them.
2.2.7 Checking Waste Container

Check the waste container and empty it.

Operator's Manual
2.3 Powering on
2.3 Powering on
2.3.1 Powering On the System
After connecting correctly the system to the power sockets, switch on the power in the
sequence presented below:
1 Turn on the analyzing unit power switch (located on the right of analyzer).
Figure 2.1 Power Switch of Analyzing Unit
(1) (2)
(1) Power Switch of Analyzing Unit

 Toggle the switch upwards to turn it on.
 Toggle the switch downwards to turn it off.
2 Turn on the printer.
3 Turn on the monitor of the operation unit.
4 Turn on the display monitor of the computer installed with the Data Management
Software.
5 Turn on the computer of operation unit.
6 Turn on the computer installed with the Data Management Software.
2.3.2 Powering On the System after Long Time Shutdown

1 Load the wash buffer.
2 Check the waste tank and solid waste container; If necessary, empty them.
3 Check the cuvettes; if needed, load new cuvettes.
4 Power on the system and run the operating system.
5 Prime the substrate tubing system and load new substrate bottles. Prime the
substrate tubing system again.
6 Execute Fluidic Prime procedure.
7 Execute Daily Clean procedure.
8 Execute System Diagnosis procedure.

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2.3 Powering on
WARNING
Please drain the hydropneumatic system of wash buffer and substrate after shutting
down the system for a long time(more than 7 days). After the drainage, prime and
wash the system with DI water or ultra-pure water and then drain it again in order to
prevent the wash buffer from crystallization which may cause system error.
If you cannot conduct the procedure on your own, please contact our customer
service department or your local distributor.
2.3.3 Starting the Operating Software

1 When the operation unit (computer) is turned on, the operating software will run
automatically.
If the system detects that the computer CPU, hardware and software environments of
the computer do not meet the requirements, or the operating system and its version,
screen resolution and database do not meet the requirements, a prompt message will
appear to require conversion to required resolution. If the conversion is canceled or
failed, exit the startup procedure to shut down or reboot.
2 Enter the username and password in the Login window, and then select OK.
NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when
logging on the system for the first time in order to prevent others from abusing the
privileges of the administrator.
If an operator forgets his password, he may ask the administrator to log on the
system and delete the username and then redefine a username; or he may contact
our customer service department or your local distributor. If the administrator
forgets his password, contact our customer service department or your local
distributor.
3 When the startup check is passed, the main screen shows. The startup procedure is
finished.
The system will display prompt message when detecting unsatisfied environment
during the startup process. Please take actions according to the instructions in the
message box.
CAUTION
To ensure accurate test results, do not start measurement until the system status
turns to Standby and the system has been turned on for about 20 minutes, so that
the reaction temperature gets steady.

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2.4 Checking System Status

After the startup procedure is finished, check the system status, such as the status of the
consumables, analyzer status, alarm status, reagent/calibration status, maintenance status
and subsystem status. If the status is not satisfied for measurement, troubleshoot and
maintain the system as instructed by 16 Alarms and Troubleshooting (page 16-1) and 15
Maintenance(page15-1).
2.4.1 Check Consumable Status

Before start testing every day, check sample diluent, substrate, cuvettes, solid waste
container, probe wash solution, wash buffer, etc. If necessary, replenish them.
1 Select Reagents - Reagent Overview.
2 Check the status of substrate, probe wash solution, wash buffer, solid waste container,
cuvette tray and waste tray according to following graphic, and take corresponding
actions.
Table 2.2 Consumables Status
Consumable When Then Actions
Required
Substrate Not loaded Need to load
substrate
Inventory is 0 Need to change

substrate
Inventory is full No actions are

required.
Inventory is neither No actions are

empty nor full required.
Loaded and No actions are

inventory is required.
sufficient, currently
in use

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Required
Probe Wash Not loaded Need to load
Solution probe wash
solution

probe wash
solution

required.
Inventory is neither No actions are

empty nor full required.
Wash buffer Not loaded Need to load

wash buffer

wash buffer

required.
Solid Waste Not loaded Need to load

Container solid waste
container

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Required
Solid waste No actions are
container is empty required.
Solid waste Need to empty

container is full solid waste
container
Solid waste No actions are

container is neither required.
empty nor full
Waste tank Waste tank is No actions are

normal. required.
Waste tank is full. Need to empty

the waste tank.
Cuvette Tray 1 Inventory is 66 No actions are

and 2 cuvettes and required.
currently in use.
Inventory is 0. Need to load

the cuvettes

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Required
Cuvette buffer No cuvettes No actions are
area required.
There are 4 No actions are

cuvettes in the required.
buffer area
3 If certain consumable is not loaded or insufficient, please refer to “2.5 Preparing

Reagents“ (page 2-16) to load.
2.4.2 Printer Status

Check the printer status indication in the system status area of the main screen:
 If the icon appears in blue, the printer is printing.
 If the icon appears in grey, the printer is not printing.
2.4.3 LIS Status

Check the LIS status indication in the system status area of the main screen:
 If appears in blue, the LIS host is connected and online.
 If appears in grey, the LIS host is off line.
2.4.4 Checking Analyzer Status

1 Click the module status icon at the top of the screen. The System Status screen is
displayed.

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Figure 2.2 "System Status" screen
The screen shows the system status and alarm status of the sample analysis module,
and sample transportation module.
 STM: indicates system status of the sample transportation module.
Status Description
Standby The sample delivery module is standby and waiting for
delivery of racks.
Running The sample delivery module is delivering racks.
Stopped
The sample delivery module fails, or the button
is pressed.
Rack Stop The sample delivery module stops delivering new
racks, while those on the track are still being
delivered. When rack stop is finished, the SDM
continues the rack delivery.
Initialization The sample delivery module is being initialized.
 SAM: It indicates system status.
 Alarm status: shows status of the sample analysis module, and sample
transportation module. Alarm levels are indicated by different colors, red for
error and yellow for warning.
2 To mask certain chemistry of the analyzer, select Mask Chem F3.
3 If the status indicates necessary maintenance, select Maintenance F7 to go to
Maintenance window to perform required procedure.
2.4.5 Checking Alarm Status

1 Check the Alarm button on the left of the main screen.

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 If it appears in yellow, it indicates that a warning occurs. Proceed to the next

step.
 If it appears in red, it indicates that an error occurs, or both warning and error
occur. Proceed to the next step.
2 Select the Alarm button and then select Log-Error log. The Error Log screen is
displayed.
Figure 2.3 Error Log screen
3 New alarm messages are indicated by corresponding colors. Select the help button in
front of a new alarm message to view relevant description and solutions.
4 Take actions according to the recommended solutions.
2.4.6 Checking Reagent/Calibration Status

1 Check the Reagent button on the left of the main screen.
 If it appears in yellow, it indicates that a warning occurs. Proceed to the next
step.
 If it appears in red, it indicates that an error occurs, or both warning and error
occur. Proceed to the next step.
2 Select the Reagent button. The Reagent/Calibration screen is displayed.

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Figure 2.4 Reagent/Calibration
3 View the reagent status. When a reagent is insufficient or exhausted, the

corresponding chemistry name and chemistries left will be indicated as follows:
 Yellow: indicates that the reagent is insufficient or expired, and the analysis will
continue. Refill or replace the reagent.
 Red: indicates that the reagent is exhausted and the analysis is stopped. Refill or
replace the reagent.
4 View the calibration status. When the calibration succeeds or fails, the Cal Status
column of the chemistry shows the calibration status in corresponding color.
 Yellow: indicates that the calibration factors of the chemistry have been
extended.
 Red: indicates that the calibration of the chemistry fails or is expired, or the
chemistry needs to be calibrated.
5 Check the calibration time left.
6 Take actions according to the calibration status.
For more information about calibration, refer to 6.6 Calibration Test.
2.4.7 Checking Maintenance Status

When the system is started up, it is necessary to check the maintenance status. If a
maintenance procedure is expired, perform it immediately to make sure that the system
will run normally. When a maintenance procedure is expired, the following buttons and
options will be indicated by corresponding color:
 Utility button on the left of the main screen
 Maintenance tab
 Maintenance button
 Scheduled Maintenance tab
 Maintenance frequency tab

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 Maintenance procedure
1 Check the Utility button on the left of the main screen. If it appears in yellow, it
indicates that a maintenance procedure is expired.
2 Select Utility - Maintenance - Maintenance.
Figure 2.5 Scheduled Maintenance screen
3 Check if the Scheduled Maintenance tab and maintenance frequency tabs appear
in yellow. If they do, it indicates that at least one maintenance procedure is expired.
4 Select the maintenance frequency tab appearing in yellow, find the expired
maintenance procedure, and then perform the maintenance.
5 Repeat steps 3 and 4 until the maintenance frequency tabs and maintenance
procedures are displayed in normal color.
2.4.8 Checking Subsystems

The subsystem status indicates the current working status of each subsystem and
hardware component, which includes the status summary, temperature, power supply,
hydropneumatic subsystem, and control modules.
Checking Subsystems
1 Select Utility - Status.

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Figure 2.6 "Status Summary" Screen
2 Select subsystem status tab.

3 Check the subsystem status. When abnormity occurs, troubleshoot errors with the
following methods:
 If a component’s temperature is beyond the valid range or abnormal and an
alarm occurs, exit the operating software and switch off the analyzer power.
After that, switch on the analyzer power again and run the operating software.
If the error remains, contact out customer service department or your local
distributor for replacement of the component.
 If a component’s voltage is beyond the valid range or abnormal and an alarm
occurs, exit the operating software and switch off the analyzer power. After that,
switch on the analyzer power again and run the operating software. If the error
remains, contact out customer service department or your local distributor for
replacement of the component.
 If a hydropneumatic component is beyond the valid range or abnormal and an
alarm occurs, exit the operating software and switch off the analyzer power.
After that, switch on the analyzer power again and run the operating software.
If the error remains, contact out customer service department or your local
distributor for replacement of the component.
 If a smart module is abnormal and an alarm occurs, exit the operating software
and switch off the analyzer power. After that, switch on the analyzer power
again and run the operating software. If the error remains, contact out customer
service department or your local distributor for replacement of the component.
Description of subsystem status

Status Summary
The status summary provides a high-level summary of the status of the system
temperatures, power supply, hydropneumatic, and control modules.

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Temperature
The actual temperature and valid range of the reagent carousel, reaction carousel,
dispersion carousel, substrate preheating and instrument interior are displayed.
Power
Status for the power supply module shows:
 The actual voltage and valid range for the main board and reagent refrigeration
board.
 The actual voltage and valid range for the radiators.
Hydropneumatic subsystem
Status for the hydropneumatic subsystem shows:
 Working status of buffer tank of the wash buffer
 The actual primary vacuum pressure and its valid range.
Smart modules
Smart module status monitors the working status of smart modules, which include
motor drive board 1~5 and reagent refrigeration unit.

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2.5 Preparing Reagents

After confirming the system status and performing the daily checks, prepare the reagents
for measurement. Chemistries without reagents loaded can be requested but will not be
included in measurements. Loading reagents is allowed when the system status is Standby,
or Incubation. In Running status, you should request reagent load before loading reagents.
After assigning reagent positions, print out the reagent list and then manually load
reagents according to it.
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise
caution when working around the probes.
BIOHAZARD
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
CAUTION
Do not drop liquid on reagent carousel control button to prevent damaging the button.
NOTE
This is a closed system, only allowing use of Mindray's reagents.
Load sufficient reagent before running tests to prevent tests interrupted by reagent
shortage.
After the analyzer is recovered from a failure stop, please take out the reagents and
rotate the gear below the magnetic bead bottle to mix the reagent.
2.5.1 Prepare Immunoassay Reagents

The system supports both manual and auto reagent load, which are completed via bar
code scanning. When manually loading the reagent, the reagent information can be
entered manually or obtained via hand-held bar code reader; when automatically loading
the reagent, the system will scan reagent bar code automatically and read reagent
information from the bar code. More than one batch or bottle of reagents can be loaded
for each chemistry. The symbol "*" indicates reagent of current bottle.
If no bar code is scanned on automatically loaded reagents, they will be unloaded
automatically. To reload these reagents, input the bar code manually. No matter reagents
are loaded manually or automatically, the newly scanned bar code will substitute for the
previous one if they are not the same.
Reagent load is allowed only when system is in “incubation“ "Standby“, “Auto mix“ or
"Reagent Load" status. In "Running" status, reagent pause has to be requested before
loading. Reagent load is not allowed in other status.
Two associated bottles of reagents (total eight cavities) are allowed to be loaded for
chemistries like folate, etc.

Operator's Manual
NOTE
Make sure there is no air bubble in reagent bottle before loading the reagent. Otherwise,
test results may be incorrect.
Manual load
When loading reagents manually, you need to enter the reagent information, which is the
only information source of the loaded reagents. You are allowed to input reagent
information before, during or after loading reagents to the reagent carousel. No other
reagent information, except for bar code, is allowed to be modified.
Manually loaded reagents have the letter “M“ (Manual) appearing near them.
Figure 2.7 Flag for manually loaded reagents
(1)
(1) Flag “M“ for manually loaded reagents

1 Check the system status and operate accordingly.
 Incubation, Standby, Auto Mix or Reagent Load: proceed to next step.
 Running: Select Reagent –Reagent/Calibration and select Reagent Stop F2 ,
to request reagent load. When the countdown for reagent load becomes 0 and
the system status is Reagent Load, a message box pops up. Select OK, and then
proceed to the next step.
To cancel reagent load, select No Stop F2 before system status changes to "Reagent
Load".
2 Select Reagent - Reagent/Calibration, or select Reagent - Reagent Overview.

3 Choose a position to which you want to load a reagent.
4 Select Manual Load F1. The Load Reagent window is displayed.
5 Move the cursor to Bar Code edit box to enter reagent bar code.

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 Enter reagent bar code via keyboard, or

 scan bar code with hand-held bar code reader.
Reagent information obtained from the bar code will automatically be shown on the
screen, and cannot be modified.
6 Select Load F3 to save the input information.

7 Select Prev F1 or Next F2 to load reagents for other chemistries.
8 Select Exit F5 to close the window.
9 Select Reagent/Calibration - Print F7 to print immunoassay reagent list.
10 Please follow the requirements of the reagent specifications inserted in the reagent
kit to gently shake the reagent pack until the reagent has been fully mixed.
11 Remove the film covered on reagent bottle, and check if the puncture membrane has
been damaged.
The reagent with damaged puncture membrane cannot be used.
12 Remove the reagent carousel cover.
CAUTION
If the system is running tests, after requesting reagent load, do not remove the
reagent carousel cover until the countdown for reagent load is 0, the system status
is Reagent Load, and the popup message is confirmed; otherwise, the tests currently
run will be invalidated.
13 Load reagents according to the reagent load list.
NOTE
While loading reagents, press the load button to rotate the reagent carousel for
convenient loading. When the reagent load button is pressed, the reagent carousel
does not stop rotating until the button is released.
14 Restore the reagent carousel cover.
Auto load
Auto load is to load bar-coded reagents to the reagent carousel, which are identified by bar
code scanning.
 Running: Select Reagent –Reagent/Calibration and select Reagent Stop F2 ,
To cancel reagent load, select No Stop F2 before system status changes to
"Reagent Load".
2 Manually rotate the gear at the bottom of the magnet bead reagent bottle or gently
shake the reagent pack until the reagent has been fully mixed.
3 Remove the film covered on reagent bottle, and check if the puncture membrane has
been damaged.

Operator's Manual
The reagent with damaged puncture membrane cannot be used.

CAUTION
If the system is running tests, after requesting reagent load, do not remove the
reagent carousel cover until the countdown for reagent load is 0, the system status
is Reagent Load, and the popup message is confirmed; otherwise, the tests currently
run will be invalidated.
5 Load reagents according to the reagent load list.
NOTE
While loading reagents, press the load button to rotate the reagent carousel for
convenient loading. When the reagent load button is pressed, the reagent carousel
does not stop rotating until the button is released.
The system scans all reagent positions automatically and read following reagent
information from the bar code:
 Chemistry
 Expiration date
 Lot number
 Bottle No.
 Bottle type
If chemistry name is "Invalid bar code", it means bar code analysis error, bar code
type error and bar code data error. Please load reagent with correct bar code.
2.5.2 Preparing Wash Buffer

The wash buffer is used for sample/reagent mixture 4-phase dispersion and regular
washing of probe and tubing.
NOTE
Please do not collect the small amount of wash buffer residue remaining in the tank for
the purpose of reuse with other wash buffer, otherwise contamination may occur.
Please do not directly touch or contaminate the front part of the inlet tubing of wash
buffer, which contacts with the liquid
1 Select Reagent – Consumable Management.
2 Select Wash Buffer.
3 Select Load F1. The Load Reagent window is displayed.
4 Remove the top of carton to expose the mouth of the tank. Remove the cap of the
wash buffer tank.
5 Loosen the cap assembly of the empty wash buffer tank and put it into the new tank.
When installing the cap assembly, lift the tank mouth with one hand while tightening
the cap with the other hand.
6 Use clean tissue to wipe the spilt wash buffer.
7 Enter the following information:

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 Volume
8 Select Load F3.
2.5.3 Loading Wash Solution

Wash solution is used to clean the probe, and can only be loaded manually. The volume, lot
number, serial number, expiration date and other information of the loaded wash solution
must be entered. When the probe wash solution is expired or exhausted, the system will
give an alarm, which will not influence the analysis. Fill more wash solution.
NOTE
Before loading wash solution, ensure that there are no air bubbles inside the reagent
bottle so as to avoid affecting washing effects.
1 Make sure system status is "Standby".
2 Select Reagent- Consumable Management.
3 Select Wash Solution.
5 Place probe wash solution in position near the probe wash well as shown in the
following figure.
Figure 2.8 Position for probe wash solution
(1)
(1) Wash solution

 Volume % (required)
 Bottle No.
 Expiration date (required)
 Lot number
7 Select Load F3.

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2.5.4 Loading Substrate

Substrate reacts with sample/reagent mixture which has completed 4-phase dispersion,
for optical measurement. Two substrate bottles can be placed side by side at the same
time. When one bottle is empty, the system will automatically switch to the other. Each
bottle of substrate can support 500 tests. If both bottles of substrate are empty, the system
cannot run tests until new substrate are loaded. Substrate in test running status is not
allowed to be replaced. Substrate not being used is allowed to be replaced in any status.
Substrate can be loaded via bar code scanning. Substrate information will be
automatically analyzed from bar code, which does not allow input or modification.
NOTE
Loading substrate before its temperature becomes steady may produce incorrect results.
When operating the analyzer, please load two bottles of substrate in order to prevent the
substrate spike from exposing in the air. Please do not remove the used-up substrate
bottle until you are about to load a new one. Before removing it, tighten the cap of the
bottle.
Quick substrate loading

Substrate in test running status is not allowed to be replaced.
1 Prepare new bottle of equilibrated substrate.
2 Scan bar code with hand-held bar code reader.
3 Remove the protective aluminum film from the bottom of the substrate bottle.
4 Loosen the substrate bottle cap about half circle.
5 Load substrate to current available position.
When loading substrate bottle, gently press down till the substrate spike in loading
position has punctured through the membrane at the bottom of substrate bottle.
6 Press the indication light corresponding to the loading position to confirm that
loading is completed.
Load substrate via consumable management screen

2 Select Substrate 1 or Substrate 2.
4 Take new bottle of equilibrated substrate.
6 Select Load F3 to save the information.
Substrate information analyzed from the bar code will automatically be shown on
the screen, and cannot be modified.
8 Remove the protective aluminum film from the bottom of the substrate bottle.
9 Loosen the substrate bottle cap about half circle.
10 Load substrate to current available position.

Operator's Manual
When loading substrate bottle, gently press down till the substrate spike in loading
position has punctured through the membrane at the bottom of substrate bottle.
Figure 2.9 Load substrate
(1) (2)
(1) ) Substrate 1 (2) Substrate 2
2.5.5 Loading Sample Diluent

The system provides function of auto sample dilution, which completes auto dilution with
sample diluent loaded on reagent carousel. Sample diluent, similar to immunoassay
reagent, supports both manual and auto load.
Load sample diluent in following procedure.
Manual load
 Running: Select Reagent –Reagent/Calibration and select Reagent Stop F2
To cancel reagent load, select No Stop F2 before system status changes to
"Reagent Load".
2 Select Reagent – Reagent/Calibration, or select Reagent - Reagent Overview.

3 Select the reagent position for the sample diluent. It can be placed in any position of
the reagent carousel.
4 Select Manual Load F1. The Load Reagent window is displayed.
5 Move the cursor to Bar Code edit box to enter reagent bar code.
 Enter reagent bar code via keyboard, or
 scan bar code with hand-held bar code reader.

Operator's Manual
Reagent information analyzed from the bar code will automatically be shown on the
6 Select Load F3 to save the information.

9 Load diluent to the specified position.
Auto load
 Running: Select Reagent –Reagent/Calibration and select Reagent Stop F2 to
request reagent load. When the countdown for reagent load becomes 0 and the
system status is Reagent Load, a message box pops up. Select OK, and then
To cancel reagent load, select No Stop F2 before system status changes to "Reagent
Load".

3 Load sample diluent to any position of the reagent carousel.
4 Cover the reagent carousel cover.
The system scans diluent positions automatically and read following information
from the bar code:
 Diluent
 Expiration date
 Lot number
 Bottle No.
 Bottle type
2.5.6 Loading and Retrieving Cuvette Tray

The system utilizes disposable cuvettes to carry sample and reagent for
chemiluminescence analysis. Cuvettes are placed on a tray to be transported to feeding
area. 2 trays can be loaded every time. Perform following steps to load or remove cuvette
trays when: before tests start, Consumable Management screen indicates insufficient
cuvettes inventory, or indication light on left front panel is flashing.
1 Open the left front door,.
2 Pull out tray rack.
3 Take out empty tray , and load tray carrying cuvettes to loading area.
4 Push in the tray rack.
5 Close the left front door.

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Consumable management screen automatically refreshes the number of

remaining cuvettes.
2.5.7 Emptying Solid Waste Container

Cuvettes with tests completed are collected in waste container. Every day before tests start
or when system prompts that waste container is full, empty the waste container in time to
avoid cuvette overflow and pollution. Determine whether the waste container needs to be
emptied according to the waste container status indication light on the front panel.
 Flashing: waste container is full and needs emptying or waste container is not loaded
and you should load the container.
 Off: The waste container is not full and you can empty it.
 On: The waste container is in use.
1 Open the left front door.
2 Take out the waste container.
3 Empty the waste container and load again.
4 Press its indication light to confirm the waste container has been emptied.
Consumable management screen automatically refreshes the remaining

volume of the waste container .

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2.6 Calibration
2.6 Calibration
For detailed information about calibration test, please refer to“ 6 Calibration“.

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2.7 Quality Control
2.7 Quality Control

For detailed information about QC test, please refer to 7 Quality Control.

Operator's Manual
2.8 Programming routine samples

This section describes how to program and run routine samples. For information about
bar-coded samples, refer to “12.1 Sample Bar Code Reader“ (page 12-2).
2.8.1 Programming Routine Samples

You are allowed to program samples one by one or in batch. Batch program is not allowed
when the sample status is In Progress, Incomplete or Complete. If the sample status is
Programmed, the new program information will overwrite the previous program
information.
Sample programming through rack supports three modes: sequential mode, rack ID mode,
and bar code mode. You may program samples by any kind of mode. For more information
about programming samples in various modes, refer to “8.2.6 Sample Analysis Mode
8-8“ (page 8-8).
Programming a sample
1 Select Program - Sample.
Figure 2.10 Sample screen
2 Enter the sample ID in the ID field.
Sample ID is composed of numbers, or letters and numbers. Up to 10 digits can be

entered. The first sample on each day is numbered as 1. Duplicate sample IDs are not
allowed before the next time the samples are released.
3 Enter rack ID and position number according to configured programming method.
4 Select a sample type from the Sample Type pull-down list.

Operator's Manual
The options include serum, plasma, urine, amniotic fluid, whole blood and other.
5 Tick the Predilution box. If the sample needs predilution, then select the chemistries.
The selected chemistries will be flagged by a number which stands for the
predilution factor as the figure shows.

If the chemistries in the sample do not need predilution, select the chemistries when
the Predilution box is not selected.
6 Enter sample comment or select one in the Comment field.
Up to 20 characters can be entered. You are allowed to define sample comments on

the Dictionary window.
7 Choose desired chemistries.
Chemistries in various statuses are indicated by symbols and color.

Table 2.1 Description of chemistry statuses
Symbol or Color Test type Description
Masked The chemistry is masked. It can be
chemistry requested but cannot be run.
Chemistry name in Available The chemistry can be requested for
black chemistry analysis.
Chemistry name in Unavailable The chemistry can be requested but
red chemistry not allowed for analysis due to the
following reasons:
 The reagent is not loaded or
inventory is 0.
 The calibration status of the
chemistry is Cal Required, Cal Failed
or Cal Time Out.
 The module on which the reagent
locates is masked.
Chemistry frame Available The chemistry can be requested for
active chemistry analysis.
Chemistry frame Unavailable The chemistry cannot be requested for
inactive and chemistry analysis due to the following reasons:
appearing in grey  Requested chemistries cannot be
chosen again for samples that are in
progress, rerun, complete or
incomplete.
Chemistry frame in Unselected The chemistry is not selected.
normal color chemistry
Chemistry frame in Selected The chemistry is selected.
blue chemistry
8 Select desired panel from the list.
When selected, the panels will appear in a blue frame.
9 Select Options F2.

Operator's Manual
Figure 2.11 "Options" window
10 Choose a sample tube type. The options include micro 0.5ml and 2ml and standard.
11 Enter the off-line dilution factor.
The input range is 2-9999, and the default is blank.
12 Enter the number of replicates.

13 Select the Predilution box; if it is selected, the chemistries of the sample will be
diluted before test. If some chemistries of the sample do not need predilution, please
select the blank from the Predilution dropdown box. When the Predilution box is
not selected and if some chemistries need predilution, please select the Predilution
ratio from their corresponding Predilution dropdown box.
14 If you want to run a chemistry with different parameters, enter the values in the
chemistry option area:
 Replicates : number of times the assay is to be run.
15 Select OK.
16 Select Save F8.
Batch programming
A maximum of 500 samples can be programmed for each batch. For batch-programmed
samples, all program information such as sample information, chemistries and patient
demographics other than position, ID and bar code are the same.
1 Select Program- Sample.
2 Enter the sample ID of the first sample.
3 Input the rack ID and position number based on the analysis mode.
6 Select the Predilution box. Refer to Programming a sample for details.
8 Select desired panels from the list.

Operator's Manual
9 Select Options F2 to set up following parameters:

 Sample cup
 Replicates
 Off-line dilution factor
 Predilution factor
 Replicates : number of times the assay is to be run.
11 Select OK.
12 Select Batch F3.
Figure 2.12 Program Batch window
13 Enter the sample ID of the last sample.

14 Select OK.
Editing patient information

You can enter the patient information at any time. When sample analysis is finished, you
can view and edit the sample information on the Current and History screens.
1 Access the Demographics window.
 Select Program-Sample, enter the sample ID in the ID field, and then select
Demog F1.
 Select Result-Current or History, choose desired sample, and select Demog F3.
Figure 2.13 Demographics window
2 To change the priority of the sample, select or deselect the STAT checkbox.
3 Enter the patient information.
4 Select Save F7 to save your input.

Operator's Manual
5 To edit demographics of other patients, select Prev F4 or Next F5.

Editing and confirming program information

If the programmed sample is not in progress, you are allowed to edit the program
information and add more chemistries. Samples that are being analyzed, incomplete or
complete must not be edited. New chemistries can be added to samples of any status. All
program information of samples in Programmed status can be edited.
2 Enter the sample ID in the Sample ID field, or enter the sample position in the Rack
and Pos fields.
The program information of the sample is displayed.
3 Edit the following information:
 STAT property
 Sample type
 Comment
 Module
 Chemistries
 Panels
 Patient demographics
 Sample options and chemistry options
4 Confirm the program information.
5 Select Save F8.
6 Select Prev F6 or next F7 to view other samples.
2.8.2 Loading Routine Samples
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult
a doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
NOTE
Before loading samples, ensure that the sample cups are free of air bubble so as to avoid
inaccurate results.
2 Select List F5.

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The sample list shows all programmed samples and chemistries, including the
following information:
 Program date and time
 Sample ID
 Bar code
 Position
 Patient name
 Chemistry
 Sample status
3 Select Print F7.
Samples are printed out.

4 Select Exit F8.
5 Load samples according to the printed list.
load samples to a rack based on the programming mode, and then put the rack in the
lane.
2.8.3 Running Routine Samples
NOTE
Do not start measurement after starting up the system until the status becomes Standby.
1 In rack ID or bar code mode, select on upper right corner of the main screen.
2 In sequential mode, the default positions can be changed: You can first select Reset
ID on the window to clear the sample IDs on the graphic rack and then select a
position on the rack; input the Start ID and the End ID and select OK. Or just select a
position on the rack and Set the Start ID and the End ID and then select OK.
3 Select OK to start analysis.

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Figure 2.14 Start conditions window-Sequential mode

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2.9 Programming STAT Samples

STAT sample program allows emergent samples to be programmed and analyzed with
high priority. The system provides common STAT and quick STAT program. Common
STAT program is used to run emergent samples with higher priority than routine samples.
Quick STAT program is mainly used to program emergent samples quickly with higher
priority than routine samples.
The system supports three sample analysis modes for racks: sequential mode, rack ID
mode and bar code mode, and any one can be chosen. For sample programming in the
three modes, refer to “8.2 Sample Programming and Processing“ (page 8-3).
2.9.1 Programming STAT Samples

Programming single STAT Sample
2 Enter the sample ID in the Sample ID field.

entered. The first sample on each day is numbered as 1. Duplicate sample IDs are not
allowed before the next time the samples are released.
4 Mark the STAT checkbox.
7 Tick the Predilution box. If the sample needs predilution, then select the chemistries.
The selected chemistries will be flagged by a triangle and a number which stands for
the predilution factor as the figure shows .

If the chemistries in the sample do not need predilution, select the chemistries when
the Predilution box is not selected.

9 Choose desired panels. When selected, the panels will appear in a blue frame.
11 Select a sample tube type. The options include microtube 0.5ml and 2ml and standard.

13 In Replicates field, enter the number of sample replicates.
The input range is 1-90, and the default is 1.
14 Select the Predilution box.

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If it is selected, the chemistries of the sample will be diluted before test. If some
chemistries of the sample do not need predilution, please select the blank from the
Predilution dropdown box. When the Predilution box is not selected and if some
chemistries need predilution, please select the Predilution ratio from their
corresponding Predilution dropdown box.
Replicates : number of times the chemistry is to be run.
16 Select OK.
17 Select Save F8.
Batch programming STAT Samples

A maximum of 500 samples can be programmed for each batch. For batch-programmed
samples, all program information such as sample information, chemistries and patient
demographics other than position, ID and bar code are the same.
2 Enter the sample ID of the first sample.
4 Mark the STAT checkbox.
7 Mark the Predilution checkbox. Refer to Programming STA Samples.
9 Choose desired panels.
10 Select Options F2 to configure following parameters:
 Sample cup
 Number of Replicates
Replicates : number of times the chemistry is to be run
12 Select OK.
13 Select Batch F3.

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Figure 2.15 Program Batch window
14 Enter the sample ID of the last sample.

15 Select OK.
Quickly Programming STAT Samples
1 Select on upper right corner of the main screen. The STAT Sample Program
window is displayed.
Figure 2.16 Quick STAT window
2 Enter the sample ID. The first emergent sample on each day is numbered as 9001.

entered. Duplicate sample IDs are not allowed before the next time the samples are
released.
3 Enter the sample position.
5 Select a sample tube type. The options include microtube 0.5ml and 2ml and
standard.
6 Confirm the default chemistries.
To choose more chemistries, select Chems F3.
7 To select more chemistries, perform the following steps:

 Select Chems F3.
 Choose chemistries and panels to be run for emergent samples.
 Select Save F7.
8 Select Demog F1 to enter patient demographics.
9 Select Options F2 to set up the following parameters:

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 Sample cup
11 Select OK.
12 Select Close F8 to close the window.
2.9.2 Loading STAT Samples
BIOHAZARD
a doctor.
CAUTION
NOTE
Before loading samples, ensure that the sample cups are free of air bubble so as to avoid
inaccurate results.
2 Select List F5.
The sample list shows all programmed samples and chemistries, including the
following information:
 Sample ID
 Bar code
 Position Patient name
 Chemistry
 Sample status
3 Select Print F7.
Samples are printed out.

4 Select Exit F8.
5 Load samples according to the printed list.

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Load samples to a rack based on the programming mode and put the rack in the
STAT lane. For information about STAT Lane Setup. Please refer to STAT lane setup .
2.9.3 Start Analysis
NOTE
After programming and loading the samples, you can start the analysis. To view sample
results, refer to “8.10 Results Recall“ (page 8-24).
Figure 2.17 Start condition window-sequential mode

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2.10 Test Status and Emergency Stop

During the analysis, you can check reagent inventory on the Reagent/Calibration screen,
view test status of calibrators, controls, routine and emergent samples on the Program –
Reagent Overview and Rack Status screens. To stop analysis, select the icon on
upper right corner of the main screen.
2.10.1 Checking Reagent Status

Select Reagent - Reagent/Calibration.
Figure 2.18 Reagent/Calibration Screen
The screen shows immunoassay reagent inventory and calibration status. When the
inventory is less than the alarm limit, the system will give an alarm and mark the
chemistry or wash solution name with different colors.
 Yellow: Warning. The number of chemistries left is lower than the alarm limit, or the
calibration status of the reagent is Cal Time Extended.
 Red: Serious. The number of chemistries left is 0, or the calibration status of the
reagent is Cal Failed, Cal Time Out, or Cal Required. The chemistry can still be
programmed but not analyzed.
 Purple: The number of chemistries left is lower than the daily consumption prompt
limit
2.10.2 Viewing Consumable Status

Select Reagent – Consumable Management.

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Figure 2.19 Consumable management Screen
The screen shows consumable inventory, days left and expiration date. When the
inventory is less than the alarm limit, the system will give an alarm and mark the
consumable with different colors.
 Yellow: Warning. It indicates insufficient or expired consumable.
 Red: Serious. The consumable is exhausted.
 Purple; The current consumable inventory is less than the daily consumption.
2.10.3 Checking Reagent Overview

1 Select Reagent - Reagent Overview.
The Reagent Overview screen is displayed. You can view the status of the reagent
carousel, each reagent, configured reagents and the consumables

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Figure 2.20 Reagent Overview screen
The screen displays current status of each reagent position. Reagent position status
includes standby, OK, exhausted, insufficient, expired, and invalid, marked by
different colors or symbols. The consumables status area displays consumables
information: name, icon and inventory. The icon indicates that the consumable
is currently in use.
2 Select a position to display its reagent information on the right.

3 Select the following buttons to perform respective operations:
 Manual Load F1 : select this button to load reagents.
 Reagent F3 : select this button to view detailed information of the selected
reagent position.
Viewing reagent information

Select a reagent position on Reagent Overview screen to view reagent information.
1 Select Reagent - Reagent Overview.
2 Select a position to display its reagent information on the right.
3 Select Reagent F3.

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Figure 2.21 Reagent Information window
4 Select Prev or Next button to view information of other reagent positions.

5 Select Close to close the window.
2.10.4 Viewing Status of Racks

The Rack Status screen shows the status of the rack in the lanes since the operating
software has been started up.
Figure 2.22 Rack Status Screen
The screen is divided into four parts: rack area, rack information area, sample status area,
and function button area.
Rack area:
Displays ID number and 10 positions of each rack.

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Rack information area:

Displays detailed information of the selected rack. In the case of calibrator or control,
name and lot number are displayed in the sample ID and bar code columns.
Sample status area:
Displays sample status symbols as shown in the table below:
Table 2.2 Sample status on racks
Symbol Color Sample Description
Status
Red Incomplete Indicates that all chemistries of
the sample have been finished but
one or more of them have no
results.
White bar Bar code Bar code is invalid, duplicate, or
code with error cannot be analyzed.
red
background
long bar code Unidentifiabl The rack is duplicate or fails in bar
e rack bar code scanning.
code
Dark grey Standby No sample has been programmed in
this position.
Light green Programmed Indicates that the sample has been
programmed but not analyzed yet.
Green Complete Indicates that all chemistries of
the sample have been finished with
results.
Light sky In progress Indicates that the sample is being
blue analyzed.
Yellow No chemistry The sample has been programmed
question requested without any chemistries.
mark
Function button area:

 Search F1: search for desired calibrators, controls and patient samples according to
defined search conditions.
 Result F2: display the Current screen, which shows all controls and patient samples
that have been programmed or analysed since the system is started up.
Follow this procedure to view rack status:
1 Select Program – Rack Status.
2 Select a rack and view the detailed information on the right side of the screen.
3 Choose the following buttons as needed:
 Search F1
 Result F2

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2.10.5 Emergency Stop

Emergency stop will terminate all measurements on the entire system, and all tests that
are not finished yet will be invalidated. Do not use emergent stop unless it is really needed,
for example, system failure. Emergency stop can be performed in any system status.
Select the icon on upper right corner of the screen, and then select OK. All
unfinished actions of the system are cancelled, all pumps and valves are turned off, and
the system enters the Stopped status.
If you want to resume the tests, select the icon of the analyzer to enter System Overview
screen and then select Home F4 to recover the system. Select to continue the tests.

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2.11 Daily Maintenance

After finishing all tests every day, you are required to perform the daily maintenance
procedures and those maintenance procedures indicated in yellow.
Daily maintenance procedures include:
 Check waste sewer and waste tank Connection
 Check consumable status
 Check syringe
 Check t probe
 Clean the exterior of the probe
 Clean the exterior of the dispersion aspirate probe
 Daily Clean
 Effect check
For more information, refer to "15.6 Daily Maintenance" (page 15-16).

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2.12 Shutdown and Log Off

2.12.1 Log Off
You can log off the operating software and use a new user name and password to log on
it.
1 Make sure that the system is in "Standby status.
2 Select Exit on the left of the main screen and select Log Off.
3 Select OK.
4 Log on again or use a new name and password to log on.

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2.12.2 Shut Down

1 Make sure that the system is in "Standby “ status.
2 Select Exit on the left of the main screen and select Shut Down. The Windows
operating system will quit automatically.
3 Switch off the power in the following order:
 Printer
 Monitor display of the operation unit
 Analyzer power switch
 Monitor display of the computer installed with the Data Management Software
(optional) or LIS (optional)
When the analyzing unit power is switched off, the refrigeration system is not running;
please take out the reagents and place them in a refrigerator.

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2.13 Check after Powering Off
2.13 Check after Powering Off

1 Check the analyzer panel for stains and wipe them off with clean gauze if any.
2 Check the waste tank. Clear it if necessary.
3 Check the sample track for racks. If any, take out the racks and store them properly.
4 Check the waste container. Empty it.
5 Check the cuvette trays. Remove the empty cuvette trays.

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2.14 Storing the Analyzer after Long Term Shutdown

1 Execute daily clean procedure.
2 Replace the substrate bottle with empty one. If the substrate is unused, take it out
and store it in refrigerator; take out the substrate bottles in equilibration positions
and store them in refrigerator.
3 Execute Fluidic Prime procedure and drain the wash buffer.
4 Drain the substrate tubing system and prime it with ultra-pure water to clean it.
After that, drain the system.
5 Install two clean empty substrate bottles and drain the substrate tubing system. Use
the ultra-pure water to clean the substrate tubing system again and drain it. Please do
not remove the empty substrate bottles until new substrate bottles are loaded for
tests in order to prevent the substrate spike from exposing in the air and being
contaminated.
6 Take out the sample racks and the sample containers.
7 Remove all reagents and store them in refrigerator.
8 Empty the waste tank if it is used.
9 Empty the waste container.
10 Clean the reagent carousel to avoid being mouldy.
11 Power off the computer and the analyzer.
WARNING
Please drain the hydropneumatic system of wash buffer and substrate after shut down
the system for a long time. After the drainage, prime and wash the system with DI water
or ultra-pure water and then drain it again in order to prevent the wash buffer from
crystallization which may cause system error.
When use the analyzer after long time shutdown. Please prime the hydro system to clean
it otherwise the analyzer may not work normally.

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Operator's Manual
3 System Setup
This chapter introduces the basic setup options of the system, which include:
 System options
 Chemistry setup
 Calibration setup
 Control Setup

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3 System Setup
3.1 System Setup
3.1 System Setup

3.1.1 Introduction
This section summarizes the setup options on the System Setup screen as shown in the
figure below.
Figure 3.1 System Setup screen
3.1.2 Sample and Test Options

The sample options allow you to:
 Set up default sample type, default sample tube and expiration date of samples
 Set up alarm for exhaustion of each reagent bottle
 Enable/Disable “Start analysis when temperature is steady“
 Result display settings
 Set up the alarm volume and beep volume
 Number of tests when special wash of probe is performed
Default sample type

The system supports a couple of sample types, which include serum, plasma, urine,
amniotic fluid, whole blood and other. The default is serum. When the default sample type
is set up, it will be selected by default for programmed samples on the Sample screen.
Default sample cup type

The system supports the standard sample cup and Microtube 0.5ml and 2 ml. The default
is the standard sample cup. When the default sample cup type is set up, it will be selected
by default for programmed samples on the Sample screen.

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3 System Setup
3.1 System Setup
Valid period of samples

Valid period of samples refers to the time interval that a patient sample is first loaded to
the sample racks and then expired. When the valid period of samples is set up, only
samples within this period are allowed for analysis. If the valid period is not set up, the
samples are valid all the time.
The valid period ranges from 1 to 99 in hour or day. The default is day.
Valid period is applicable to patient samples rather than calibrators and controls. Once
the collection time is entered, the system will calculate the valid period from the time
when the sample is collected; otherwise, the time when the sample is programmed will be
used for calculating the valid period.
Start Analysis When Temperature is Steady

The analyzer temperature can be monitored before analysis begins.
 When the Start Analysis When Temperature is Steady checkbox is selected, the
system will check before analysis begins if the temperature of the reaction carousel,
dispersion carousel and substrate is normal. If the temperature is normal, you are
allowed to select to start analysis; if the temperature is abnormal, a message
will appear indicating analysis is forbidden in current condition.
 When the Start Analysis When Temperature is Steady checkbox is not selected,
you are allowed to select to start analysis.
Alarm for each reagent bottle

Each chemistry can have more than one bottle of reagent loaded. You can set up alarms for
the case that one of the bottles is running out.
Select the Alarm for Each Reagent Bottle option. When one reagent bottle is exhausted,
the system will give an alarm. If the option is not selected, the system will not give an
alarm until the number of chemistries left becomes 0.
Result display settings

This option is used to set up flags and color for results less than or greater than the
reference range, as well as color for results less than or greater than the critical range.
Click the relevant color setup button, choose desired color, and then select OK. The system
will display flags in the Flag column of the Current and History screens and on patient
reports if the test result is less than or greater than the reference range. The flags can be
composed of numbers, letters and symbols for no more than 10 digits.
The default flags for reference range are ^ and v. If a result is greater than the high limit, ^
will appear near the result; if a result is less than the low limit, v. will appear near the
result. If test results are beyond the critical range, they will appear in the set color.
Clogged
Select this option to perform the special wash of probe when the probe is clogged,
3.1.3 Instrument Setup Options

In the Instrument Setup window, you are allowed to:
 Auto startup Setup
 Dictionary setup
 Auto Maintenance Setup

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3 System Setup
3.1 System Setup
 Set up system communication options

 Select language for the operating software
 View software versions
 System date and time
 Set up auto release time of samples
 Voice tone setup
 Optimize result display
 Customize sample information
 Customize patient demographics
 Customize reagent information
 Set up sample analysis mode
 Set up alarm limit for consumables
 STAT lane setup
 Disable cuvette tray
 Substrate air bubble detection setup
 Consumable check before test
Auto startup window

The option is used to set up the auto startup time of the entire system.
The system allows you to choose a weekday and specific time that the system will be
started up automatically. When the time is reached, the system will be started up
automatically if it is off. For more information, refer to “11.3 Auto Startup “ (page 11-6).
Dictionary setup
The Dictionary option is provided for setting up and managing frequent data information,
including: result unit, sample type, sample comment, QC comment, etc.
For more information, refer to “11.4 Dictionary“ (page 11-7).
System communication options

The Com Setup option is used to set up the IP address for connections between the PC
and LIS. For more details, please refer to “13 LIS “ (page 13-1).
Select language
The operating software is displayed by default in the same language as the current
operating software. You are allowed to change the language of the operating software.
Select System Setup-Instrument F1-4 Language, and then choose a language from the
following options: Chinese, English, Turkish, Russian, French, Portuguese, Italian, Spanish,
and Polish. Select OK to save the settings. The language you select will take effect only
when you reboot the operating software.
Viewing software version

The Version Info window shows the versions of the operating software, control software,
and database. For more information, refer to refer to “11.6 Software Version“ (page
11-10).

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3 System Setup
3.1 System Setup
Date and time

The Date and Time option allows you to set the current date and time, select the
date/time formats to be displayed on software screens and printed reports, and restore
default date and time formats.
When adjusted, the date and time will influence the time left of reagents and calibration,
shelf life of samples, and run length of two-control evaluation. The date and time cannot
be edited when the system status is Running. Modification of the date and time will not
affect samples on the Current screen or QC evaluation and Twin-Plot chart.
Follow this procedure to change system date and time:
1 Select Utility-System.
2 Select Instrument F1.
3 Select 7 Date/Time.
Figure 3.2 Date/Time window
4 Select date in the Date area.

5 Set the time in the Time area.
Manually enter the hour, minute and second, or move the cursor to hour, minute and
second, and then click the up/down arrows to adjust the time.
6 Choose a date format from the Order pull-down list.

 yyyy-mm-dd: e.g. 2010-07-28
 dd-mm-yyyy: e.g. 28-07-2010
 mm-dd-yyyy: e.g. 07-28-2010
7 Choose a time format from the Time Format pull-down list.
 24-hour: e.g. 14:33:27
 12-hour: e.g. 02:33:27
8 Select OK to save your input information.
9 To restore the date and time defaults, select Restore Defaults.
10 Select Exit to close the window.

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3 System Setup
3.1 System Setup
Auto release of samples

The system allows setting of daily release time of samples. When the set time is reached,
samples on the rack that are currently in Complete status will be released automatically.
For more information, refer to 8.5.3 Auto Release of Samples (page 8-15).
Voice tone setup

This option is used to customize the alarm sound and beep sound, as well as import
audio files from external storage devices.
For more information, refer to “11.7 Voice Tone Setup“ (page 11-11).
Optimize result display

This option is used to set up display mode of sample results that are beyond the
measuring range.
For more information, refer to “8.9 Optimizing Result Display“ (page8-22).
Customize sample information

This option is used to set up sample information displayed on the Sample screen.
For more information, refer to "8.6 Customizing Sample Information (page8-17).
Customize patient demographics

This option is used to set up patient information displayed on the Demographics
window.
For more information, “8.7 Customizing Patient Demographics“ (page 8-18).
Customize reagent display

This option is used to set up reagent information displayed on the reagent/calibration
screen.
For more information, refer to “5.2 Customizing Reagent Display“ (page 5-4).
Sample analysis mode setup

The system support three sample analysis modes: sequential mode, rack ID mode and bar
code mode. Only one of the three modes can be used simultaneously.
For more information, refer to “11.8 Sample Analysis Mode Setup“ (page 11-13).
Consumable check before test

Consumable Check Before Test is used to disable or enable checking of consumable
inventory, expiration date or calibration status before test.
For more information, refer to “11.10.2 Consumable Check Before Test“ (page 11-15).
STAT lane setup

STAT lane is used to carry STAT samples.
1 Select Utility-System Setup.
3 Select 17 STAT Lane Setup.
4 Select the lane to be set for STAT samples.
5 Select OK.

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3 System Setup
3.1 System Setup
Disable cuvette tray

In standby or stopped status, tray 2 and the cuvette buffer area can be disabled.
3 Select 16 Disable cuvette tray.
4 Select the area you want to disable.
5 Select OK.
Consumable Alarm limit

The alarm limit for exhaustion of consumables such as sample diluent, substrate, wash
buffer, wash solution, cuvette, waste container can be defined. For more information,
please refer to 5.4 Consumable Inventory Alarm Limits Setup(page 5-6)
3.1.4 Print Setup

The Print Setup window allows you to set up print templates, auto print options and
printer. For more information, refer to “9.2 Print Setup “ (page 9-5).
3.1.5 Bar Code Setup

The Bar Code Setup option is used to set up sample bar code options. For more
information, refer to “12 Use of Bar Code“ (page 12-1).
3.1.6 Host Communication Setup

The Host option allows you to set up the host communication options and the
transmission methods of test results. For more information, refer to “13.1 Host
Communication“ (page 13-2).
3.1.7 User Accounts and Permissions

The User option allows you define and edit user accounts, passwords and permissions.
For more information, refer to “11.2 User and password setup“ (page 11-3).

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3 System Setup
3.2 Chemistry Setup
3.2 Chemistry Setup

3.2.1 Introduction
The system only supports closed-reagent chemistries and can only be run with the
reagents provided by our company. Parameters can be imported from parameter chart,
sample type, print name, result unit, inventory alarm limit, decimal and reagent daily
consumption limit. If you are not going to use certain closed-reagent chemistries, you are
allowed to mask them, and if needed some day, unmask them.
Figure 3.3 Chemistries screen
3.2.2 Editing and Deleting Chemistries

Editing chemistries
You are allowed to edit user-defined chemistries if:
 You have sufficient permissions, and
For user permission setup, refer to "11.2 User and password setup" (page 11-3).
 The system is not running tests.
Editing chemistries is similar to defining a chemistry. Refer to other sections in this
chapter for details.
Deleting chemistries
Make sure that you have sufficient permission to delete a chemistry. For user permission
setup, refer to "11.2 User and password setup" (page 11-3).
1 Remove the reagent from the reagent carousel.

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3 System Setup
3.2 Chemistry Setup
If the reagent is loaded manually, unload it manually first.

2 Select Utility - Chemistries.
3 Select the chemistry in the chemistry list.
4 Check if the following conditions are satisfied:
 The selected chemistry is not requested or run for samples, calibrators and
controls.
 The corresponding reagent has been unloaded from the reagent carousel.
6 Select Delete.
All test results, data and parameters related to the chemistry are cleared.
3.2.3 Define/Edit Chemistries

The Define/Edit Chemistries window is as shown below:
Figure 3.4 Define/Edit Chemistries window
Chem
Chemistry name is the only identity of a chemistry and must not be duplicate. A chemistry
name can be composed of up to 10 characters, and is not case sensitive.
No.
No. is the only ID of a chemistry, which is imported from parameter chart and must not
be modified.
Chemistry
This field is the complete form of chemistry name, which is imported from parameter
chart and must not be modified.

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3 System Setup
3.2 Chemistry Setup
Sample type
Sample type refers to the samples to which the chemistry is applicable. The options
available in the Sample Type pull-down list is serum only.
The system allows definition of chemistry parameters for more than one sample type.
Print Name
Print name is displayed on patient reports representing a chemistry. It can be composed
of up to 15 characters. The print name can be edited and duplicate. When this field is left
blank, the short form of the chemistry name will appear on reports.
A chemistry is only represented by its print name on patient reports and appears on
other reports in the form of short name.
Unit
.Choose a result unit from the pull-down list.
When the result unit is changed, the system will automatically refresh the finished
sample results, calibrator concentrations, control concentrations, reference ranges and
offsets in light of the conversion rate between units
Reagent alarm limit

Set up the reagent alarm limit for the chemistry. The input range is 1-100, and the default
is 10. It can be left blank. When the number of chemistries left is lower than the limit, an
alarm will occur; if no alarm limit is defined, the system will not give an alarm.
Only when sample type is Serum can reagent alarm limit be defined.
Daily consumption limit

Set up the daily consumption limit of the reagent for the chemistry. The input range is
1-100, and the default is blank. When the number of chemistries left is lower than the
limit but higher than the reagent alarm limit or the reagent alarm limit is not set, the
Chems Left on the reagent/calibration screen will be flagged with purple.
Decimal
Decimal specifies the number of decimal places for test results.
Up to 3 decimal places can be set up and respectively correspond to 0, 0.1, 0.01 and
0.001.
On board stability
The on board stability refers to the number of days that the reagent can be kept valid
since uncapped at the first time. It cannot be modified.
Auto calibration
Lot changed: The system will remind you to run a calibration when you use reagents of a
different lot.
Calibration time: The system will remind you in 30 minutes before the calibration is
timed out.

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3 System Setup
3.2 Chemistry Setup
3.2.4 Flag Qualitative Result

When the analyzer is in the status of standby, incubation or stop, you can flag the
immunoassay and calculation chemistry results qualitatively. The results will be
represented by a qualitative flag. Qualitative flag is applied to all sample types.
1 Select an immunoassay or calculation chemistry.
 Select Utility - Chemistries.
 Select a chemistry.
 Select Define F1.
 Select Qualitative F3.
Or
 Select Utility - Chemistries.
 Select Calculations F6.
 Select a calculation chemistry and select Define F1.
 Select Flag Qualitative Results.
Figure 3.5 Qualitative Result window
2 Select the Use Qualitative Result checkbox.

3 Enter the qualitative range and flag.
For instance, type in “10” in the first edit box of the Range field, and then enter “+” in
the Flag field of the same row. If the chemistry result (L1) contained in a sample is
lower than or equal to 10, the “+” sign will be added to the result in the patient
report. Type in “20” in the second edit box below the Range icon and “+-” in the
second edit box below the Flag icon. If the chemistry result (L2) is greater than 10
and lower than 20, the result will be flagged with the “+-” sign. The cycle continues. If
the result is greater than L5, the six flag will appear on the patient report.
4 Select OK to save the settings.
3.2.5 Slope/Offset Adjustment

The slope and offset are calculation factors that are used to compensate the test results of
a chemistry when the QC result of the chemistry is slightly deviating.

Operator's Manual
3 System Setup
3.2 Chemistry Setup
When the measurement is finished, the system adjusts the test result with the following
equation:
y=kx+b
Where, x is the test result before adjustment, y is the result after adjustment, k is the
slope, and b is the offset..
Before setting up the calculating factors, make sure that you have sufficient permissions
and the system is not running tests.
2 Select Slope/Offset F5.
Figure 3.6 Slope/Offset Adjustment window
3 Choose a chemistry.
4 Double click the Slope field and then input the slope.
Positive, negative and decimal numbers (-99999999~99999999) can be entered.

The maximum input length is 8 digits.
5 Double click the Offset field and then input the offset.
Positive, negative and decimal numbers (-99999999~99999999) can be entered.

The maximum input length is 8 digits.
6 Repeat step 3 to 5 to set up the slope and offset for other chemistries.
7 Select Save to save your input information.
8 To restore the factory settings of slope and offset, select Restore Defaults.
9 Select Close to exit the window.
3.2.6 Reference/Critical RangeSetup

The system allows the setup of reference/critical /user defined ranges for each chemistry.
 Reference range indicates the allowable concentration range of a normal sample.

Operator's Manual
3 System Setup
3.2 Chemistry Setup
 Critical range is the allowable result range from the perspective of clinical diagnosis.
 User defined range is the allowable result range defined by the user.
If a result is greater than the high limit of the reference range, ∧ will appear near the
result; if a result is less than the low limit of the reference range, ∨ will appear near the
result. If a result is greater than the high limit of the critical range, ∧! will appear near
the result; if a result is less than the low limit of the critical range, ∨! will appear near
the result.
Prior to defining the reference/critical range, ensure that you have sufficient permissions
and the system status is not Running.
Defining/Editing reference/critical range/user defined range

For each chemistry, different reference/critical ranges/user defined range can be set
according to sample type, gender and age; multi-line reference ranges can be set for the
chemistry.
2 Select Ref Range F4.
Figure 3.7 Reference/Critical Range Setup window
3 Choose a chemistry from the Chemistry pull-down list.

4 Choose a sample type for the reference and critical range.
5 Choose patient gender for the reference and critical range.
6 Enter the age range in the Age Range field.
 Enter the age low limit in the first edit box.
 Enter the age high limit in the second edit box.
 Choose an age unit from year, month, day and hour.
7 Enter the reference range.
 Enter the reference range low limit in the first edit box.
 Enter the reference range high limit in the second edit box.
 The maximum input length is 8 digits.

Operator's Manual
3 System Setup
3.2 Chemistry Setup
Or set up multi-line reference ranges for the chemistry:

 Select Ref Range F1.
 Enter the interval and the reference range on the popup window.
 Select Save.
Figure 3.8 Multi-line reference range setup
8 Enter the critical range.

 Enter the critical range low limit in the first edit box.
 Enter the critical range high limit in the second edit box.
 The maximum input length is 8 digits
9 Enter the user defined range.
 Enter the user defined range low limit in the first edit box.
 Enter the user defined range high limit in the second edit box.
 The maximum input length is 8 digits.
10 Select the rerun type.
 Reflex
 Repeat
 Dilution
11 Input the priority for the rerun type. The input range is the integer within 1-100; 1
means the highest priority.
12 Select Save F7. The reference/critical range are displayed in the middle list.
 Select Discard F6 to abort the input information.
13 Select Prev F4 or Next F5 to set up reference/critical range/user defined range for
more chemistries.

Operator's Manual
3 System Setup
3.2 Chemistry Setup
Setting up default reference/critical range

You are allowed to select a default reference/critical range for a sample type and gender.
The default range appears in red. Only one default reference/critical range is allowed for
the same sample type and gender of each chemistry.
3 Choose the chemistry name, sample type, gender and age range.
4 Choose a reference/critical range in the middle list.
6 Select Default on the popup window.
The selected reference/critical range are set as the default of the chemistry. The
system will check the test result, and if necessary, flag and rerun the chemistry. For
details of reference range flags, refer to "3.1.2 Sample and Test Options".
Deleting a reference/critical range/user defined range

1 Select Utility-Chemistries.
3 Choose the chemistry name, sample type, gender and age range.
4 Choose a reference/critical range you want to remove.
6 Select Delete.
7 Select Delete Selected Record or Delete Selected Records.
8 Select OK.
Selecting reflex chemistries

3 Choose the chemistry name, sample type, gender and age range and set up
reference/critical /user defined range.
4 Select Reflex from the Rerun Type dropdown box and input Priority.
5 Select Reflex F3.

Operator's Manual
3 System Setup
3.2 Chemistry Setup
Figure 3.9 Select Reflex chemistries
6 If you want to rerun the chemistries by diluting the sample, select Auto Dilute.
7 Select reflex chemistries.
 A reflex chemistry can be the chemistry itself.
 Select Clear to clear all the selected chemistries.
 Select Cancel to cancel the setup.
8 Select OK.

Operator's Manual
3 System Setup
3.3 Calibration Setup
3.3 Calibration Setup

For details about calibration setup, please refer to 6.3 Calibration setup,6.4 Calibration
Options and 6.5 Auto Calibration.

Operator's Manual
3 System Setup
3.4 QC Setup
3.4 QC Setup
For details about calibration setup, please refer to 7.2 QC Setup,7.3 QC Evaluation and 7.4
Auto Quality Control.

Operator's Manual
4 Operation Theories
This chapter gives brief introduction of the operation theories of the instrument,
principles of measurement and calibration math models.

Operator's Manual
4.1 Principles of Measurement

4.1.1 Introduction
The system performs measurement with the following principles: sandwich and
competitive immunoassay methods. Both methods are applied to measurement of
macromolecule complex, such as HCG and ANTI-HBc. Competitive method is usually
applied to measurement of small molecule complex, such as FT4 and E2.
4.1.2 Sandwich Method

Sandwich method provides double-antibody sandwich method (chemistry of antigen) and
double-antigen sandwich method (chemistry of antibody). Take two-step double-antibody
sandwich method for example; it is applied to multivalent antigen with more than 2
epitopes. The working principle is: Firstly, specific antibody is bound onto solid phase;
then, sample containing antigen of interest is added to incubate and react with
solid-phase antibody; wash buffer is used to wash the reaction mixture to remove
interfering substances unbound to the solid-phase antibody; labeled antigen is added to
incubate so that it can be bound with antigen on another epitope to form the
antibody-antigen-labeled antibody complex; solid-liquid phase is isolated and washed;
finally, luminescence base fluid is added for reaction and optical measurement. The
working principle is illustrated in following figure:
Figure 4.1 Double-Antibody Sandwich Method
37 ℃
incubation
Dispersion
Anti-body coated micro Sample Enzyme-labeled

magnetic beads antibody

Operator's Manual
4.1.3 Competitive Method

Competitive method is applied to quantitative measurement of antigen and half-antigen,
as well as measurement of antibody. Competitive method is applied to measurement of
small molecule complex. Take antigen measurement for example, the working principle is:
Firstly, specific antibody is bound onto solid phase; then, specimen containing antigen of
interest and labeled antigen are added at the same time; the mixture is incubated for the
antigen of interest and labeled antibody to competitively bind with the solid phase; then
it is washed to remove the unreacted antigen and labeled antibody; finally, luminescence
base fluid is added for reaction and measurement. The working principle is illustrated in
following figure:
Figure 4.2 Double-Antigen Sandwich Method
37 ℃
incubation
Dispersion
Sample Enzyme-labeled
Antibody coated micro antigen
magnetic beads

Operator's Manual
4.2 Analysis Mode
4.2 Analysis Mode

4.2.1 Introduction
The system performs measurement mainly with one-step method and two-step method.
The major difference lies in steps necessary for the measurement. One-step method
includes one-time incubation and one-time dispersion, while two-step method includes
two times of incubation and one or two times of dispersion.
4.2.2 One-step Method

One-step method proceeds as follows: adding specimen, adding labeled antibody (antigen),
incubating for reaction, dispersion, adding substrate and optical measurement. Generally
speaking, competitive method belongs to one-step method, while some double-antibody
sandwich methods also belong to one-step method. One-step method is illustrated in
following figure:
Figure 4.3 One-step method procedure
Sample Labeled antibody or

antigen
Cuvettes
Incubating
Remove unbound reactant via

dispersion
Incubating
Substrate
Instrument
measurement
4.2.3 Two-step Method

According to counts of dispersion, two-step method is divided into two-step with one
dispersion and two-step with two dispersions. Generally sandwich method belongs to
two-step method.
Two-step method with one dispersion proceeds as follows: adding sample, labeling
antibody (antigen), incubating, adding labeled antibody (antigen), dispersion, adding
substrate and optical measurement. Two-step with one dispersion procedure is
illustrated in following figure:

Operator's Manual
4.2 Analysis Mode
Figure 4.4 Two-step with one dispersion
Specimen Labeled antibody or

antigen
Cuvettes
Incubating
Labeled antibody or
antigen
Incubating

dispersion
Incubating
Substrate
measurement
Two-step method with two dispersions proceeds as follows: adding specimen, labeling
antibody (antigen), incubating, dispersion, adding labeled antibody (antigen), incubating,
dispersion, adding substrate, and optical measurement. Two-step with two dispersions
procedure is illustrated in following figure:

Operator's Manual
4.2 Analysis Mode
Figure 4.5 Two-step with two dispersions
Specimen Labeled antibody or

antigen
Cuvettes
Incubating
Remove unbound analyte via

dispersion
Labeled antibody or
antigen
Incubating

dispersion
Incubating
Substrate
measurement

Operator's Manual
4.3 Calibration Math Model

4.3.1 Introduction
The system provides the following two calibration math models:
 Quantitative (4PLC)
The system utilizes 1-3 point calibration, to adjust calibration master curve to obtain
calibration results.
According to the calibration results, sample RLU is converted to the value of
concentration.
 Qualitative (COI)
The system utilizes 1-2 point calibration, to convert calibrator RLU to Cutoff value
according to the formula set in advance. Determine if sample is positive or negative by
comparing sample RLU and Cutoff value.
4.3.2 Quantitative Calibration Type and Calculation

The system utilizes 1-3 point calibration to adjust calibration master curve to obtain
calibration results.
Generating Calibration Master Curve:
Calibration master curves are generated for each different lot of reagent.
Calibration master curve utilizes calibration formula in the form of 4PLC (4-parameter
logistic curve):
P1  P4
CPS  P3
 P4
C
1  
 P2 
Where, CPS is count of photons, and C is concentration.
This method includes 4 parameters: P1, P2, P3 and P4.
Different levels of calibrator concentration and CPS over several analyzers are fit by
non-linear regression algorithm, so as to obtain parameters for 4PLC calibration formula
and generate calibration master curve packed in the calibrator kit.
Adjusting Calibration Master Curve:
You are allowed to only perform 1-3 point calibration, and use adjustment algorithm
specified for each chemistry to adjust parameters of the 4PLC calibration master curve,
so that the adjusted calibration results can be obtained.
4.3.3 Calculating Cutoff Value for Qualitative Analysis

One-point Qualitative Analysis:
Cutoff value is obtained by one-point calibrator RLU. Determine if sample is positive or
negative by comparing sample RLU with Cutoff value.
One-point calibrator signal (Cal CPS) converted to cutoff value is illustrated as follows:
Cutoff=a*Cal CPS+b

Operator's Manual
Where, a and b are parameters specific for different chemistries.
Two-point Qualitative Analysis:

Cutoff value is obtained by two-point calibrator RLU. Determine if sample is positive or
negative by comparing sample RLU with Cutoff value.
Two-point calibrator signals (Cal1 CPS and Cal2 CPS) converted to cutoff value is
illustrated as follows:
Cutoff=a*Cal1 CPS+b*Cal2 CPS+c
Where, a, b and c are specific parameters for different chemistries.

Operator's Manual
5 Reagents
This chapter provides you with functions and operating instructions associated with
reagent.

Operator's Manual
5 Reagents
5.1 Overview
5.1 Overview
5.1.1 Introduction
This chapter introduces the advanced application of the reagent module. Perform the
following operations according to the practical conditions in your laboratory:
 Customizing reagent information
 Sorting reagents
 Setting up consumable inventory alarm limits
 Printing reagent information
 On-line load of reagents
 Off-line load of reagents
 On-line replacement of reagents
 Off-line replacement of reagents
 Unloading reagents
5.1.2 Reagent/Calibration Screen Overview

Select Reagent in the function button area of the main screen. The Reagent/Calibration
screen is displayed. The screen displays inventory and calibration status of all loaded
immunoassay reagents or sample diluents.
Figure 5.1 Reagent/Calibration Window
The screen shows all loaded immunoassay reagents, including the following information:
 Position: position of the reagent on the reagent carousel.
 Chemistry: name of the chemistry.

Operator's Manual
5 Reagents
5.1 Overview
 Chemistries left: It refers to the number of chemistries left of the reagent.

 Tests left: It refers to the remaining tests of each reagent bottle.
 Days left: the difference of reagent expiration date and current date and the
uncapping time, whichever the less. When a negative value is displayed, it indicates
that the reagent is expired and should be replaced immediately.
 Lot No.: displays the lot number of the reagent.
 Serial No.: displays the serial number of the reagent.
 Calibration status: calibration status of the chemistry, including, Cal Required,
Requested, Calibrated, Cal Failed, Cal Time Out and Cal Time Extended.
 Time left: the time left when the calibration factors are expired. It will be displayed
only when the calibration status is Calibrated or Cal Time Out. When the time left is
less than 30 minutes, the system displays a message indicating calibration time out;
when the calibration time is exceeded, the calibration factors can no longer be used,
and you are allowed to recalibrate the chemistry or extend the calibration time.
5.1.3 Consumable Management Window

Select Reagent – Consumable Management to enter Consumable Management screen.
The screen displays consumables information, load date, volume, days left and expiration
date.
Figure 5.2 Consumable management screen
The screen is divided into two areas: the upper column displays reagent name, volume
load date, days left, expiration date, lot number and serial number; the lower area of
function buttons are used to perform operations.

Operator's Manual
5 Reagents
5.2 Customizing Reagent Display
5.2 Customizing Reagent Display

5.2.1 Introduction
The reagent information on the reagent/calibration screen can be tailored and displayed
in desired order.
5.2.2 Customizing Reagent Information

1 Select Utility - System Setup.
3 Select 13 Customize Reagent Display.
Figure 5.3 Customizing Reagent Display
4 Select checkbox of reagent information to display it on the reagent/calibration

screen, deselect checkbox to cancel the display.
5 Select Up and Down to adjust the display order of reagent information.
6 Select Save to save the settings.

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5 Reagents
5.3 Sorting Reagents
5.3 Sorting Reagents

5.3.1 Introduction
Reagents on the reagent/calibration screen can be sorted by name, position, chemistries
left, days left and calibration time left, and a V-shape symbol appears to the right of the
sort criteria. Prior to loading reagents or running calibrations, sort the reagents to display
the desired ones in the front.
5.3.2 Sorting Reagents

1 Select Reagent - Reagent/Calibration ;
2 Choose a sorting criterion, and then click on the corresponding list head to
rearrange the reagents.
To view or load reagents, choose the following standards:
 Reagent Positions
 Chemistry name
 Chemistries left
 Tests left
 Days left
To view calibration status or run calibrations, choose the following standard:
 Calibration status
 Calibration time left

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5 Reagents
5.4 Consumable Inventory Alarm Limits Setup
5.4 Consumable Inventory Alarm Limits Setup

5.4.1 Introduction
The system provides options to set up inventory alarm limit and daily consumption limit
for sample diluent, substrate, wash solution, cuvettes and solid waste container. When
inventory is lower than the alarm limits during or before the analysis, the system will give
an alarm and mark the consumable name in yellow on the Consumable Management
screen. When inventory is lower than the daily consumption limits during or before the
analysis, the system will give an alarm and mark the consumable name in purple on the
Consumable Management screen.
5.4.2 Setting Up Consumable Inventory Alarm Limits

3 Select 15 Consumable Inventory Alarm Limit.
4 Set up inventory alarm limit and daily consumption limit for sample diluent,
substrate, , probe wash solution, cuvettes and solid waste container.
5 Select Save.

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5 Reagents
5.5 Printing Reagent Information
5.5 Printing Reagent Information

5.5.1 Introduction
When viewing reagent/calibration information or the reagent carousel status, you are
allowed to print, by chemistry or by position, all reagents or those with remaining
chemistries less than the alarm limit or equal to 0, or all reagent information. You are also
allowed to print the entire special reagent list.
5.5.2 Printing Immunoassay Reagent Information

1 Select Reagent - Reagent/Calibration.
2 Select Print F7.
Figure 5.4 Print window
3 Select Print by chemistry or Print by position.

4 Set the print range:
 Print reagents with insufficient chemistries left
 Print all reagents
5 Select OK.
5.5.3 Printing Consumable Information

2 Select Print F7.
Consumable management information includes: consumable name, volume, load date,

days left, expiration date, lot number and serial number.

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5 Reagents
5.6 On-line Load of Reagents

5.6.1 Introduction
The on-line load of reagents is performed while the system is running tests. Before
starting an on-line load, request for reagent load, do not load reagents until all started tests
are finished for reagent dispensing.
You are allowed to load consumables during test running. Perform loading according to
indication light status.
WARNING
BIOHAZARD
may be caused.
5.6.2 On-line Load of Immunoassay Reagents and Sample Diluent

1 Select Reagent –Reagent/Calibration
2 Select Reagent Stop F2 to request for reagent load.
Probe is stopped automatically, the system status area shows a countdown for
reagent load, and a message box will be displayed when the countdown is finished.
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise,
the tests currently run will be invalidated.
3 To manually load reagents and sample diluents, select OK and then select Manual
Load F1, and remove the reagent carousel cover; to automatically load reagents, just
remove the reagent carousel cover.
4 Load reagent and sample diluent to reagent carousel.
NOTE
Press the load button to rotate reagent carousel when loading reagent. When the
button is pressed, the reagent carousel will rotate continuously until the button is
released.

 For manual load of reagents, enter the reagent bar code on the Load Reagent
window or scan the reagent bar code with a handheld bar code reader.
 For auto load of reagents, the system scans all reagent positions automatically
and read reagent information from the bar code.

Operator's Manual
5 Reagents
5.6.3 On-line Load of Substrate, Wash Solution and Wash Buffer

2 Select substrate, wash solution or wash buffer to load.
For on-line load of wash solution, please Select Reagent –Reagent/Calibration and
select Reagent Stop F2. Rack transfer is stopped automatically, the system status
area shows a countdown for load. A message box will be displayed when the
countdown is finished.
4 Load substrate, wash solution or wash buffer.
For information about substrate status indicator light, refer to "Substrate status
button" (page1-18).
For steps to load consumables, refer to "2.5 Preparing Reagents" (page2-16).

Operator's Manual
5 Reagents
5.7 Off-line Load of Reagents
5.7 Off-line Load of Reagents

5.7.1 Introduction
The off-line load of reagents is performed while the system is not running any tests. You
are allowed to directly place the reagents on the reagent carousel or in the designated
positions.
WARNING
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles. Do not touch the reagent directly with
your body; otherwise, skin wound or inflammation may be caused.
5.7.2 Off-line Load of Immunoassay Reagent and Sample Diluent

2 Load immunoassay reagents and sample diluent.
NOTE
released.

 For manual load of reagents and sample diluent, enter the reagent information
on the Load Reagent window or scan the reagent bar code with a handheld bar
code reader.
 For auto load of bar-coded reagents and sample diluent, the system scans all
reagent positions automatically and read reagent information from the bar
code.
5.7.3 Off-line Load of Substrate, Wash Solution and Wash Buffer

2 Select substrate, wash solution or wash buffer to load.
3 Select Load F1. The Load Reagent window
4 Load substrate, probe wash solution or wash buffer.

Operator's Manual
5 Reagents
5.8 On-line Replacement of Reagents

5.8.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while the system is
running tests, you should request for reagent stop and replace the reagent immediately to
ensure that the following measurements will be done smoothly.
You are allowed to replace consumables during test running. Perform replacement
according to indication light status.
5.8.2 On-line Replacement of Immunoassay Reagent and sample diluent

1 Select Reagent- Reagent/Calibration, or select Reagent - Reagent Overview.
2 Confirm the reagent to be replaced and select the reagent position.
3 Select Reagent Stop F2 on the Reagent/Calibration screen to request for
reagent load.
Rack transfer is stopped automatically, the system status area shows a countdown
for reagent load, and a message box will be displayed when the countdown is
finished.
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise,
the tests currently run will be invalidated.
4 To manually load reagents and sample diluents, select OK and then select Manual
Load F1, and remove the reagent carousel cover; to automatically load reagents, just
remove the reagent carousel cover.
5 Remove the reagent and sample diluent.
6 Place the new reagent and sample diluent.
NOTE
released.

 For manual load of reagents, enter the reagent information on the Load
Reagent window or scan the reagent bar code with a handheld bar code reader.
 For auto load of b reagents, the system scans all reagent positions automatically
and read reagent information from the bar code.
5.8.3 On-line Replacement of Substrate

During test running, you are allowed to replace only the substrate that is not in use.
Substrate in use is not allowed to be replaced.
2 Select substrate to be replaced.
3 Select Load F1 and the Load Reagent window is displayed.

Operator's Manual
5 Reagents
4 Replace the substrate that is not in use according to the indicator light.
For information about substrate status indication light, refer to "Substrate status
button" (page1-18).
For steps to load substrate, refer to "2.5.4 Loading Substrate" (page2-21).
5.8.4 On-line Replacement of Wash Buffer

2 Select Wash Buffer.
4 Replace the wash buffer.
5 Input the volume.

Operator's Manual
5 Reagents
5.9 Off-line Replacement of Reagents
5.9 Off-line Replacement of Reagents

5.9.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while the system is not
running any tests, you should replace the reagent immediately to ensure that the
following measurements will be done smoothly.
5.9.2 Off-line Replacement of Immunoassay Reagent and Sample Diluent

2 Remove the reagent or sample diluent.
3 Load new immunoassay reagent or sample diluent.
NOTE
released.

 For manual load of reagents and sample diluent, enter the reagent information
on the Load Reagent window or scan the reagent bar code with a handheld bar
code reader.
 For auto load of reagents and sample diluent, when the measurement is started
next time, the system scans all reagent positions automatically and read reagent
information from the bar code.
5.9.3 Off-line Replacement of Substrate, Wash Solution and Wash Buffer

2 Select substrate, wash solution or wash buffer to be replaced.
4 Replace substrate, probe wash solution or wash buffer.

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5 Reagents
5.10 Loading and Retrieving Cuvette Tray and Emptying Solid Waste Container
5.10 Loading and Retrieving Cuvette Tray and Emptying Solid Waste
Container
5.10.1 On-line Loading and Retrieving Cuvette Tray
Loading and retrieving cuvette tray is allowed during test running.
Load or take out cuvette tray according to the tray status indication light on the front
panel:
 On: The unit is working. Do not pull out the drawer.
 Flashing: There is no cuvette on the tray or you have selected the cuvette tray to load
cuvette on the screen or the cuvette tray have been taken away. You are required to
load new tray or take out old tray.
1 Make sure that the cuvette tray indication light on left front door is off or flashing.
2 Open the left front door and you will see two drawers.
3 Pull out the drawer.
4 Take out empty tray and put the new tray carrying cuvettes on the drawer.
5 Push in the drawer.
6 Close the left front door.
Consumable Management screen automatically refreshes the number of
remaining cuvettes.
5.10.2 On-line Emptying Solid Waste Container

Empty the container according to the indicator light of the waste container:
 Flashing: The container is full; need to empty it. Or the container is taken away; need
to load it .
 Off: The container is not full. Emptying is allowed.
 On: The container is in use.
1 Make sure that the solid waste container indication light on left front door is flashing.
For indication light status, refer to "Solid Waste Cont" (page1-21).

2 Open the left front door.
3 Take out the waste container.
4 Empty the waste container and load it again. Press the indicator light button beside
the waste container to confirm you have loaded it.
Consumable Management screen automatically refreshes the remaining

volume of the waste container.
5.10.3 Off-line Loading and Retrieving Cuvette Tray and Emptying Solid
Waste Container
The operation procedures in non-testing status is similar to that in test running status,
and the difference lies in no need to observe indication light status. For more information,
refer to "2.5 Preparing Reagents“ (page2-16).

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5 Reagents
5.11 Unloading Reagents

5.11.1 Introduction
If some chemistries will not be used, you are allowed to clear the chemistry parameters
and unload the relevant reagents. To re-assign reagent positions, you can unload the
reagents and relocate them. The Unload option is used to remove immunoassay reagents,
sample diluent and substrate.
When a chemistry is requested for quality control, sample analysis or calibration, all
reagents of the chemistry still can be unloaded.
When a reagent is unloaded, all relevant information and its position are cleared. The
reagents that are being used for analysis cannot be unloaded.
5.11.2 Unloading Immunoassay Reagents and Sample Diluents

1 Make sure that the reagent or sample diluent to be unloaded is not being used for
analysis.
3 Select the reagent position to unload reagent.
4 Select Manual Load F1.
5 Select Unload F4.
7 Take out the reagent or sample diluent from the reagent carousel.
5.11.3 Unloading Substrate

1 Make sure that the substrate to be unloaded is not being used for analysis.
2 Select Reagent- Consumable Management.
3 Select the substrate to be unloaded.
4 Select Load F1.
5 Select Unload F4.
6 Remove the reagent carousel cover, remove substrate from the substrate loading
area.

Operator's Manual
5 Reagents

Operator's Manual
6 Calibration
This chapter describes functions and operation instructions associated with calibration,
which include:
 Calibration status and alarm indication
 Calibration setup
 Calibration options
 Auto Calibration
 Extending calibration time
 Running calibrations
 Calibration results recall

Operator's Manual
6 Calibration
6.1 Overview
6.1 Overview
In a calibration, the known calibrator concentration and COI parameters P1～P4 of the
reagent calibration master curve are used to calculate calibrator fitting RLU. Master curve
RLU is adjusted with calibrator's measured RLU and fitting RLU, according to the
algorithm of each chemistry. Then, the final sample result is calculated by 4PLC fitting of
the adjusted master curve RLU on each calibration point with each concentration point
on the master curve.
When the calibration status is abnormal, the system will give an alarm and display the
calibration status with specific color. When you set up the auto calibration conditions, the
system will automatically remind you of calibrating chemistries. Expired calibration
factors can be used again by extending the calibration time. Current calibration factors
can be "rejected" and the latest valid ones are used to calculate sample results.

Operator's Manual
6 Calibration
6.2 Calibration Status and Alarm
6.2 Calibration Status and Alarm

On the Reagent/Calibration screen, the chemistries are indicated with various texts and
colors for different calibration status. Chemistries in Cal Required, Cal Failed or Cal Time
Out status can be requested but will not be run.
Check the chemistries’ calibration status frequently and take relevant actions according to
the following table.
Table 6.1 Calibration Status
Calibration Description Severity Color
status
Cal Required Indicates that the chemistry needs to be Serious Red
calibrated.
This status appears when the chemistry
is not calibrated or auto calibration
conditions are satisfied; or calibration
information or chemistry parameters
have been modified, such as calibrator
and concentration, or result unit.
Requested Indicates that the chemistry has been Normal No color
requested for calibration or the indication
calibration test is running.
Calibrated Indicates that the chemistry has been Normal No color
calibrated and has not exceeded the indication
calibration period.
Cal Failed Indicates that the test has finished but Serious Red
cannot calculate the final result; or the
calculated result exceeds the
acceptance limits; or calibration is
requested but test is invalidated during
calibration.
Cal Time Out Appears when the chemistry exceeds Serious Red
the calibration period.
Cal Time Indicates that the calibration period has WARNING Yellow
Extended been extended and the current
calibration factors can be used without
time limit.

Operator's Manual
6 Calibration
6.3 Calibration setup

6.3.1 Introduction
Perform calibration settings in the following order:
 Define/Edit a calibrator
 Input calibration master curve information
 Set up calibrator position
6.3.2 Define a Calibrator

Calibrator information is entered via bar code scanning, and the system automatically
analyzes information from the bar code, such as chemistry, lot number and expiration
date. Scan calibrator bar code only by hand-held bar code reader.
1 Select Reagent – Cal Setup.
2 Select Define F1.
Figure 6.1 Read Calibrator Information Card window
Calibrator information analyzed from the bar code will automatically be shown on
the screen, and cannot be modified.
4 Select Save to save the calibrator information or press the enter key on the
keyboard to save the information.
5 To define more calibrators, repeat step 3 and 4.
6.3.3 Input Calibration Master Curve Information

Calibration master curve information is imported via bar code scanning, and the system
automatically analyze information from the bar code, such as chemistry and lot number. It
is allowed to scan calibration master curve only by hand-held bar code reader.

Operator's Manual
6 Calibration
1 Select Reagent –Cal Setup.

2 Select Master Curve F3.
Figure 6.2 Master Curve Information window
3 Scan bar code of the master curve placed in the reagent box with hand-held bar code
reader.
Master curve information analyzed from the bar code will automatically be shown
on the screen, and cannot be modified.
4 Select Save to save the master curve information or press the enter key on the
keyboard to save the information.
5 To add more master curves, repeat step 3 and 4.
6.3.4 Assign Calibrator Position

You are allowed to modify and release calibrator position.
1 Select Reagent – Cal Position.
2 Find the calibrator you want to set the positions by scrolling the scroll bar.
3 Choose a rack number or lane number and the position for C0,C1 and C2.

Operator's Manual
6 Calibration
If you want to clear the rack number(lane number) and the positions, select Discard
F7 and redefine the positions for the calibrator.
4 Select Save F8.
6.3.5 Select Sample Cup Type

Sample cup type can be selected for the calibrator.
1 Select Reagent-Cal Position
2 Select Sample Cup F5.
3 Choose sample cup type.
4 Select Save.
5 Select Exit to exit the window.
6.3.6 Delete Calibrator

When a calibrator is deleted, all calibration settings and its position are cleared, and it
cannot be used for programming. The stored test results of the calibrator can be recalled
according to the chemistry name. only calibrators that are not requested or run can be
deleted.
1 Select Reagent –Cal Setup.
2 Choose a reagent in the left list.
3 Choose the calibrator to be deleted in the right list.
4 Select Delete F6.
5 Select OK.

Operator's Manual
6 Calibration
6.4 Calibration Options

Calibration options include: extending calibration time, reject and individual bottle
calibration.
6.4.1 Extending Calibration Time

Introduction
Calibration factors that exceed the calibration period cannot be used for result calculation.
The calibration status becomes Cal Time Out and the chemistry can no longer be run. The
system will display a warning message in 30 minutes before the calibration is timed out,
and you are allowed to recalibrate the chemistry or extend its calibration time. If you are
certain that the calibration factors are correct and valid, you may prolong their validity
period by using the calibration time extension function. A calibration time can be
extended only if the current calibration of the chemistry is timed out or calibrated. The
results calculated based on extended calibration factors will be flagged with “EXT”.
Extending Calibration Time

2 Choose a chemistry you want to extend.
3 Select Cal Options F8.
4 Select Extend Calibration Time.
5 Select OK. The calibration factors of the selected chemistry can be used without time
limit.
Removing an Extended Status

Calibration extension is not absolutely definite. Recalibrate the chemistry to remove the
extended status.
6.4.2 Reject
Introduction
If the current calibration fails but sample analysis needs to be performed immediately,
you may use the Reject function to reject the current calibration factors, and use the
latest valid ones for calculating sample results. Calibration factors of status other than
Requested and Cal Required can be rejected. Rejected calibration factors cannot be
rejected again.
Rejecting a Calibration
1 Select Reagent-Reagent/Calibration.
2 Choose a chemistry you want to reject.
3 Select Cal Options F8.
4 Select Reject from the Calibration Options window.
5 Select OK. Calibration factors of the selected chemistry are rejected and use the latest
valid ones for calculating sample results.

Operator's Manual
6 Calibration
Removing Reject Status

Recalibrate the chemistry to remove its Reject status.
6.4.3 Individual Bottle Calibration

Introduction:
The property of some reagent bottles of the same lot may change, so the reagent bottle
can be calibrated individually. After calibration, its calibration parameters cannot be
applicable to other reagent bottles and it also cannot acquire the calibration parameters
from others.
Set up individual bottle calibration

1 Select Reagent –Reagent/Calibration.
2 Choose the reagent. ( not in the status of “calibration requested”)
3 Select Calibration Options F8.
4 Select Individual bottle calibration.
5 Tick Calibration by bottle.
6 Select OK.
If you want to cancel individual bottle calibration, just cancel ticking Calibration by
bottle and the calibration status of the reagent returns to that of the reagents of
same lot.

Operator's Manual
6 Calibration
6.5 Auto Calibration

6.5.1 Introduction
Based on the auto calibration conditions, the system can determine chemistries that need
to be calibrated and remind you through calibration status and color indication. Auto
calibration conditions include:
 Reagent lot changed
 Cal time
Calibration will be run automatically when reagent lot number is changed, or he
chemistry exceeds the calibration period.
6.5.2 Auto Calibration Setup

1 Select Utility- Chemistry Setup.
2 Choose a chemistry.
3 Select Define F1.
Figure 6.3 Define/Edit chemistries window
4 Choose auto calibration conditions:

 Lot changed: The system will remind you to run a calibration when you use
reagents of a different lot.
 Calibration time: The system will remind you in 30 minutes before the
calibration is timed out and display the chemistry’s calibration status with
yellow.
5 Select OK F7.
6.5.3 Auto Calibration Reminding

When the auto calibration conditions are satisfied, the system will remind you through
the calibration status, prompt message and color indication.

Operator's Manual
6 Calibration
 If you choose the Lot Changed option, the system will show a message indicating
calibration is required when you use reagents of a different lot.
 If you choose the Cal Time option, the system will remind you in 30 minutes before
the calibration is timed out and display the chemistry name and calibration
statuswith yellow.
6.5.4 Removing Auto Calibration

To disable the auto calibration, perform the following steps:
1 Deselect all auto calibration conditions on the Define/Edit Chemistries window.
2 Select Save F7.

Operator's Manual
6 Calibration
6.6 Calibration Test

Running calibration is to calculate calibration factors for sample result calculation.
Generally, calibration is recommended when one of the following conditions occurs:
 QC alarms are given while the reagent, calibrator and control sample are within the
expiration date.
 Reagent lot or bottle is changed.
 The calibration factors of a chemistry are expired.
 Calibration rules and calibrators are changed.
 Syringe, probe and so on are replaced.
Recalibration is required when result unit is changed.
For more information about calibration setup, refer to “6.3 Calibration setup“ (page6-4).
6.6.1 Requesting Calibrations

Calibrations can be requested only when calibration information has been set up,
calibrators are not expired, and master curve information has been scanned.
Before requesting a calibration, make sure that the calibrator has been loaded to correct
position.
Figure 6.4 Reagent/Calibration
2 Select the chemistry that needs calibration.
Select the up/down arrow buttons to select more chemistries.

3 Select Cal F5.

Operator's Manual
6 Calibration
Requesting a calibration based on calibration status

When calibration status of a chemistry is Cal Required, Cal Failed or Cal Time Out, the
system will give an alarm. Perform the following steps to request a calibration based on
the calibration status.
1 Check the Reagent button on the left of the main screen.
 Yellow: indicates that a warning occurs.
 Red: indicates that a serious error occurs.
2 If the Reagent button is highlighted, select Reagent-Reagent/Calibration.
3 Select the down-arrow button on the right side of the screen to display the
immunoassay reagents.
4 Check the chemistries of which the calibration status is highlighted.
5 Select Cal F5.
6.6.2 Cancel calibration request

When the calibration test is requested but it does not start, you can cancel the calibration
request by selecting No Cal F6. If the calibration test has started but the rack carrying
calibrator has not entered rack transfer unit or if the calibration has been invalidated (e.g.
the emergency stop button is selected or the analyzer is stopped by error.), you are
allowed to cancel the calibration test. The calibration status is restored to the most recent
status before the calibration test is requested.
6.6.3 Loading Calibrator
BIOHAZARD
Inappropriate handling of calibrators may lead to biohazardous infection. Do not touch
the calibrators directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the calibrators, follow standard laboratory safety procedure
and consult a doctor.
CAUTION
Do not use expired calibrators; otherwise, unreliable test results may be caused.
1 Select Reagent-Reagent/Calibration.
2 Select Load List F4.
The calibrator list shows all requested chemistries as well as calibrators, positions,
concentration, lot number and expiration date.
3 Load calibrators according to the calibrator list. load calibrators to a rack, and then
put the rack in the lane
Ensure that calibrators are loaded to the correct positions.
6.6.4 Running Calibrations
NOTE

Operator's Manual
6 Calibration
After requesting calibrations and load calibrators to the sample rack, you can start the
calibration test.

Operator's Manual
6 Calibration
6.7 Recalling Calibration Results

On the Calibration Result screen you are enabled to recall the current and stored
calibration factors of a chemistry. The Current calibration factors are obtained in the
recent calibration and are being used for result calculation. You are allowed to recall the
calibration data and calibration trends during the specified period, and archive or print
the calibration results.
6.7.1 Recalling Current Calibration Result

1 Select Reagent – Calibration Result.
The screen shows all the calibrations requested and results on the day, as default,
including the following information:
 Chemistry
 Lot No.
 Serial No.
 Flag
 Math Model
 Calibration status
 Calibration date and time
2 To recall calibration results of all chemistries, select All from the Chem pull-down
list.
3 To recall calibration results of certain chemistry, select the chemistry name from the
Chem pull-down list.
4 Select Search F1.
The calibration results of selected chemistries are displayed in the result list.
5 To print the current calibration results, select Print F7.
6.7.2 Recalling History Calibration Results

1 Select Reagent – Calibration Results.
2 Choose the History option button.
3 Select the date range in the Cal Date field.
4 Choose a chemistry from the Chem pull-down list.
5 Select Search F1.
The calibration factors used within the specified period are displayed on the screen.
 Cal Data F2
 Archive F5
 Trend F6
 Print F7

Operator's Manual
6 Calibration
6.7.3 Archiving Calibration Results

The system allows you to archive all searched calibration results to a storage device, such
as U disk, floppy disk, etc. Archived calibration results are displayed in the same format as
on the software screen. The archiving file is of.csv format and named by date and time.
1 Select Reagent- Calibration Results.
2 Search for desired calibration results.
3 Select Archive F5.
4 Confirm archiving path and file name.
5 Select Save.
6.7.4 Recalling Calibration Data

The system allows you to view the detailed calibration information such as chemistry
name, reagent information, math model, calibration status, substrate lot number,
calibration date/time and calibrator’s concentration level and the RLU at each
concentration point.
1 Select Reagent- Calibration Results.
2 Search for desired calibration results.
3 Select a chemistry you want to view the calibration data.
4 Select Cal Data F2.
Figure 6.6 Calibration data window
5 Select Prev F4 or Next F5 to recall the calibration data of the previous or next
chemistry.
6 Select Print F7 to print the calibration data.
6.7.5 Calibration Trends

Calibration graphical trends summarize a chemistry’s calibrations during a period of time
and reflect the trends of the calibrations. Calibration graphical trends show the trends of
each calibrator's RLU of the chemistry.

Operator's Manual
6 Calibration
1 Search for desired calibration results on the Calibration Results screen.

2 Choose a chemistry in the result list.
3 Select Trend F6.The Calibration Trends window is displayed.
Figure 6.7 Calibration Trends
4 Choose a trend type you want to recall from the Trend Type pull-down list.
5 Select the date range in the Cal Date field.
6 Select Search F1.
The trend within the specified period is displayed on the screen.

7 Choose the Tabular Trend tab to view the trend data.
Figure 6.8 Calibration Tabular Trend

Operator's Manual
7 Quality Control
This chapter describes applications of quality control, which include:

 Daily and monthly QC procedure
 QC alarm indications
 QC result flags
 Control status
 QC setup
 QC evaluation
 Auto QC
 QC test
 Control results recall

Operator's Manual
7 Quality Control
7.1 Overview
7.1 Overview
7.1.1 Introduction
A QC run may require more than one control sample. You are recommended to use two
control samples, one with normal values (within the reference range) and the other with
abnormal values (beyond the reference range).
To ensure the system performance, run control samples every time after you perform a
calibration, or change the reagent lot, or maintain and troubleshoot the instrument.
7.1.2 Quality Control Operating Procedure

After you define a control, chemistry and QC rules, there is no need to edit them
frequently, and you are only required to run control samples every day to make sure that
the system works well. Run control samples according to the following procedure:
Figure 7.1 Quality control operating procedure
Define Set up two- Print monthly

Set up QC Choose QC Enable auto
Monthly control
parameters rules
control
QC QC plot and
operations samples evaluation QC summary
Program Running
Load control Recall QC Print real-time
control control
Daily operations samples results QC results
samples samples
7.1.3 QC Alarms
The system provides the real-time monitoring of quality controls, and check if the QC
results are under control when a QC run is finished. If the results exceed the reference
range, the system will give an audible alarm and shows an alarm message indicating the
chemistry name, control name and control rules. For instance, “Chemistry:, control:, 1-3s
out of control!”. In this situation, you should stop the analysis and find the causes of the
failure, and resume the analysis after solving the problem.
7.1.4 QC result flags

When a QC result fails, the system will give an audible alarm and show alarm message to
remind you of the failure. Moreover, the following flags will appear for failed results in the
Flag column of the QC reports.
 13s
 12s
 R4s
 22s
 41s
 10x
The system checks the failed QC results for system error or random error and then flag
them accordingly. A “#” sign indicates a systematic error, and an asterisk “*” indicates a
random error. For more information about QC result flags, refer to “16.4 Data
alarm“ (page16-9).

Operator's Manual
7 Quality Control
7.1 Overview
7.1.5 Control Status

When you choose a control on the Quality Contro screen, the current status of the
control is displayed in the Status field. It is necessary to understand the control statuses.
The table below shows the various statuses of control samples.
Table 7.1 Descriptions of control status
Control Status Description
N/A Indicates that the control is not programmed for analysis.
Requested Indicates that the control sample has been programmed but not
analyzed yet.
In Progress Indicates that the control sample is being analyzed.
Incomplete Indicates that all chemistries of the control sample have been
finished but one or more of them have no results.
Complete Indicates that all chemistries of the control sample have been
finished with results.

Operator's Manual
7 Quality Control
7.2 QC Setup
7.2 QC Setup
7.2.1 Introduction
Perform QC settings in the following order:
 Define/Edit a control
 Select chemistries
 Set up control concentration parameters(when calibrator is manually set up)
 Assign control position
 Setting up QC rules
7.2.2 Defining/Editing a Control

Control can be set up manually or imported and the system automatically analyzes
information from the bar code, such as lot number, expiration date and reference value. It
is allowed to scan control bar code by hand-held bar code reader.
Adding or editing controls is allowed only when the system status is Incubation, Standby
or Stopped.
Importing Control
1 Select QC – QC Setup.
2 Select Import Control F4.
Figure 7.2 Read Control Information Card window
Control information analyzed from the bar code will automatically be shown on the
4 Select Save to save the control information.

5 To add more controls, repeat step 3 and 4.

Operator's Manual
7 Quality Control
7.2 QC Setup
Set up Control Manually

1 Select QC-QC Setup.
2 Select Define F1.
Figure 7.3 “Define Control”window
3 Type in the control name.

4 Enter the control number.
5 Enter the lot number.
The lot number can be composed of characters or numbers. The combination of
control name and lot number must not be duplicate.
7 Select expiration date for the control.
When the expiration date is exceeded, the control can still be programmed and
analyzed, while the system flags the test result with”!” in the Flag column to remind
you of replacing the expired control.
9 To define more controls, select New and repeat step 3 to 9.
7.2.3 Selection of Chemistries

After defining a control, you need to select chemistries for which the control will be used.
When selecting chemistries, make sure that the system status is Incubation, Standby or
Stopped, and the control status is not Programmed or Incomplete.
2 Choose a control in the left list.
3 Select Chems F2 .

Operator's Manual
7 Quality Control
7.2 QC Setup
Figure 7.4 Chemistries window
4 Choose chemistries for the control. Use the right-arrow button to display more
chemistries.
5 To choose all chemistries in the list, select Select All.
6 To deselect the chemistries, select Clear.
7 Select OK.
7.2.4 Set Up Control Concentrations

You are required to set up the average concentrations and SDs of a control for each
chemistry after defining the control and choosing chemistries. Only the control with
positions assigned and concentrations determined can be used for programming.
To run quality control for special calibrations, you must define the mean value and SD;
otherwise, no control results will be calculated. If the sub chemistries of a special
calculation have no mean value and SD, QC evaluation will not be done and QC plot cannot
be recalled.
1 Select QC- QC Setup.

Operator's Manual
7 Quality Control
7.2 QC Setup
Figure 7.5 QC setup screen
The chemistries configured for the control are displayed in the right list.
3 Select the Mean column of a chemistry and type in the average concentration for it.
The concentration must be above 0 with no more than 8 digits.

4 Select the SD column of a chemistry and type in the standard deviation for it.
The SD must be above 0 with no more than 8 digits.

5 Choose the unit for the chemistry.
6 Select Save F8 to save your input information.
7.2.5 Assign Control Position

Once the control information is entered. You are allowed to assign control position only
when the system status is Standby or Stopped. You are allowed to modify and release
control position.
1 Select QC – Control Position.

Operator's Manual
7 Quality Control
7.2 QC Setup
Figure 7.6 Define/Edit Controls window
3 Select rack ID(Lane number) for the control and select a position for the control.
If you want to clear the defined positions, select Discard F7 and then resign the
positions for the control.
3 Select Save F8.
7.2.6 Setting Up QC Rules

You should set up the control rules after defining a control and determining
concentrations for it. The controls without QC rule can still be programmed and analyzed
but will not be monitored for error detection. You are allowed to change the QC rules
when the system is not running any tests.
2 Select Rules F3.The QC Rules Setup window is displayed.

Operator's Manual
7 Quality Control
7.2 QC Setup
Figure 7.7 QC Rules Setup window
3 Choose a chemistry from the Chem list.

4 Choose QC rules in the Westgard Rules area.
5 If you assign a couple of controls for the chemistry, you are allowed to enable the
Two-Control Evaluation option.
Those controls not contained in the two-control evaluation will be monitored
according the Westgard rules.
6 Select the first control in the Control (X) field.
7 Select the second control in the Control (Y) field.
9 Repeat step 3 to 8 to set up quality control rules for other chemistries.
7.2.7 Deleting a Control

You are allowed to delete controls when the system is not running any tests. When a
control is deleted, the control information, concentration parameters and QC results as
well as the control position are cleared. If the deleted control is included in the two-control
evaluation, the relevant two-control evaluation will be disabled. Those controls
programmed for analysis cannot be deleted.
3 Select Delete F6.

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7 Quality Control
7.3 QC Evaluation
7.3 QC Evaluation
7.3.1 Introduction
The system provides the Westgard rules for evaluating QC results of the chemistries, and
give alarms and flags when the obtained QC results are beyond the reference range. Since
every chemistry may have one or more control samples, the QC results can be evaluated
with different rules accordingly. Those controls that are not included in any lots will be
evaluated as single controls.
7.3.2 Evaluation of Single Control

The Westgard rules for evaluation of single controls are listed in the table below:
Table 7.2 Westgard rules for single controls
Rules Description Flag Error Type
12s One result is between ±2 and ±3 N/A N/A
standard deviations from the
assigned mean concentration.
13s One result is greater than ±3 13s *(1)
standard deviations from the
assigned mean concentration.
22s Two continuous results are greater 22s #(2)
than +2 or -2 standard deviations
from the assigned mean
concentration, e.g. (Xn, Xn-1)
41s Four continuous results are greater 41s #
than +1 or -1 standard deviation
concentration, e.g. (Xn, Xn-1, Xn-2,
Xn-3)
10x Ten results being compared are on 10x #
the same side, e.g. (Xn, Xn-1, Xn-2,
Xn-3..Xn-9)
(1) An asterisk “*” indicates a random error, which requires no special action but must
not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special consideration.

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7 Quality Control
7.3 QC Evaluation
The evaluation procedure of single controls is shown in the figure below:

Figure 7.8 Evaluation procedure of single controls
Control data
No
>2S In-control
Yes No
Yes
12S Warning
No
No No No
13S 22S 41S 10X
Yes Yes Yes Yes
Out of control
7.3.3 Two-Control Evaluation

What is a run
A QC run is based on two control samples: C1 and C2, and at most one QC run is
performed for each chemistry. The system allows the definition of QC run interval on the
System Setup screen. The maximum QC run interval is 24 hours.
1 Select QC –QC Setup.
2 Select QC Para F5.
3 Type in the QC run length in the Run Length field.
Enter an integer between 1 and 24. The default is 24.
4 Select OK.
Two-control evaluation rules

In every QC run, two results are obtained: Xn and Yn, which are used to define a point on
the Twin-plot chart. In this way, a complete twin-plot chart is drawn based on all the QC
results and used for detecting systematic errors and random errors.
The Westgard rules for two-control evaluation are listed in the table below:
Table 7.3 Two-control evaluation rules
12s One result is between ±2 and ±3 standard N/A N/A
deviations from the assigned mean
concentration.
13s One result is greater than ±3 standard 13s *(1)
deviations from the assigned mean
concentration.
22SA Two results (Xn, Yn) of a run are 22s #(2)
simultaneously greater than +2 or -2
standard deviations from the assigned
mean.

Operator's Manual
7 Quality Control
7.3 QC Evaluation

R4s One result of a run is greater than +2 R4s *
standard deviations from the assigned
mean and the other greater than -2SDs.
22SW Two continuous results of a control are 22s #
greater than +2 or -2 standard deviations
from the assigned mean concentration,
e.g. (Xn, Xn-1), (Yn, Yn-1).
41SA Results of two continuous runs are 41s #
greater than +1 or -1 standard deviation
from the assigned mean, e.g. (Xn, Yn,
Xn-1, Yn-1).
41SW Four continuous results of a control are 41s #
greater than +1 or -1 standard deviations
from the assigned mean concentration,
e.g. (Xn, Xn-1, Xn-2, Xn-3), (Yn, Yn-1,
Yn-2, Yn-3).
10XA Results of five continuous runs (10 10x #
results) compared are on the same side,
e.g. (Xn, Yn, Xn-1, Yn-1, Xn-2, Yn-2,
Xn-3, Yn-3, Xn-4, Yn-4).
10XW Ten continuous results (10 results) of a 10x #
control are on the same side, e.g. (Xn,
Xn-1, Xn-2, Xn-3..Xn-9), (Yn, Yn-1, Yn-2,
Yn-3..Yn-9).
(1) An asterisk “*” indicates a random error, which requires no special action but must
not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special consideration.
The systematic errors in two-control evaluation correspond to those in single-control
evaluation as follows:
 22SA\22SW corresponding to 22s.
 41SA\41SW corresponding to 41s.
 10XA\10XW corresponding to 10x.
The procedure of two-control evaluation is shown in the figure below:
Figure 7.9 Two-control evaluation workflow
Measured values of X
and Y controls
No
12S In control
Yes
No
No No No No No No No
13S 22SA R4S 22SW 41SA 41SW 10XA 10XW
Yes Yes Yes Yes Yes Yes Yes Yes
Out of control (occurrence of alarm)

Operator's Manual
7 Quality Control
7.4 Auto Quality Control

7.4.1 Introduction
The system provides the auto quality control function. When the conditions for auto
quality control are satisfied, a message will pop up reminding you to program controls.
The control samples automatically run can be selected on the QC Parameters window.
The conditions for auto quality control include:
 Number of samples: indicates the number of patient samples. After the given
number of samples is finished, the system will run the selected control(s)
automatically.
 When calibrated: The system will automatically run the chemistry for the selected
control(s) every time when the chemistry is calibrated. Auto QC is not applicable to
non-measurement calibrations, such as recalculation and editing.
When the control samples automatically run are selected, all chemistries configured for
the control samples will be run.
7.4.2 Auto QC Setup

1 Select QC - QC Setup.
Figure 7.10 QC Parameters window
3 Set up the conditions for auto quality control:

 No. of Samples : enter the number of samples for auto QC run. The input
range is 10-500, 0 means auto QC is disabled.
 When Calibrated : select the checkbox to allow the system to run controls
when a chemistry is calibrated.

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7 Quality Control
4 Choose controls to be run automatically.
One or more controls can be selected.
5 Select OK.
7.4.3 Auto Quality Control

When the conditions for auto quality control on racks are satisfied, a message will pop up
reminding you to program controls. Program controls according to “2.7 Quality Control“.
Load the controls on the control rack and put the rack into lane.
7.4.4 Removing Auto QC Status

To remove an auto QC status, set the Number of Samples to 0, and deselect the When
Calibrated option on the QC Parameters window.

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7 Quality Control
7.5 QC Test
7.5 QC Test
QC results are tools used to monitor the system performance. To check if the system is
running normally and steadily, you are recommended to run control samples every day.
The system provides two modes to run control samples, auto and manual. New
chemistries can be added no matter in which status the control samples are. The control
programs can be edited when the control status is Programmed rather than In Progress.
7.5.1 Programming Control Samples

QC runs are requested by programming control samples. You are allowed to choose a
control, control position and sample cup type as well as chemistries and panels for
measurement. At least one chemistry must be selected for control programming. If a
chemistry has no QC parameters set up, such as mean concentration and standard
deviation, or is masked or has no reagent loaded, the chemistry cannot be used to
programming controls.
1 Select Program-Quality Control.
Figure 7.11 Quality Control Screen
2 Select a control from the Control pull-down list.

The chemistries assigned for the control are selected automatically.
3 Input a position in the edit box .
The options include all positions defined for the control. To define a control, rack ID
and position have to be assigned for the control.
For more information about control position assignment, refer to "7.2.5 Assign
Control Position " (page 7-7).
4 Choose a sample cup type to be used by the selected control.

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7 Quality Control
7.5 QC Test
The options include Standard and Microtube 0.5ml and 2ml.

5 Choose desired chemistries and panels in the chemistry list.
If the chemistries included in a panel are set up for QC parameters, they will be
selected automatically; otherwise, the panel can be selected but will not be
programmed for quality control.
6 Select Standby Rgt F3 to choose the reagent available for QC test (not the current
reagent) .
Figure 7.12 Select standby reagent
7 Select Save F8.

8 To program other controls, select Prev F4 or Next F5, and then repeat steps 2 to 7.
7.5.2 Loading Control Samples
BIOHAZARD
Inappropriate handling of control samples may lead to biohazardous infection. Do not
touch the control samples directly with your hands. Wear gloves and lab coat, if
necessary, goggles. In case your skin contacts the control samples, follow standard
laboratory safety procedure and consult a doctor.
CAUTION
Do not use expired control samples; otherwise, unreliable test results may be caused.
1 Select Program-Sample.
2 Select List F5.
The sample list shows all programmed patient samples, control samples and
chemistries, including the following information:
 Sample ID or control name
 Bar code or lot number
 Position

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7 Quality Control
7.5 QC Test
 Patient name (of patient samples)

 Chemistry
 Sample status
3 Select Print F7.
Samples and controls are printed out respectively.
4 Select Exit F8.

5 Load control samples according to the printed list.
Load controls to a rack, and then put the rack in the lane. Ensure that controls are
loaded to the correct positions.
7.5.3 Running Control Samples
NOTE
After programming and loading the control samples, you can start the QC test.

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7 Quality Control
7.5 QC Test
7.5.4 Auto QC
Controls can be run automatically based on specified samples and calibration. When auto
QC is enabled, the system will automatically run all chemistries of the selected controls
once the conditions are met.
For more information about auto quality control, refer to "7.4 Auto Quality Control
3 Select controls for auto QC in the control list.
4 Set up the conditions for auto quality control:
 Number of samples
 When calibrated
For more information about auto QC setup, refer to 7.4 Auto Quality Control
5 Select on upper right corner of the main screen. The Start Conditions window
is displayed.
6 Select OK.

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7 Quality Control
7.6 Recalling Control Results

The Recalling Control Results option allows you to view control sample results, L-J chart,
twin-plot chart, analysis data and data summary.
Patient demographics and rerunning are not applicable to controls.
Sample information and rerunning are not applicable to controls.
7.6.1 Control Sample Results

1 Select Result-Current or History.
 The Current screen displays all incomplete patient samples and control samples,
as well as those programmed on the current day.
 The History screen displays all patient samples and control samples
programmed before the current day.
2 Choose a result recall mode:
 By sample
 By chemistry
3 When recalling results by sample, choose a control in the left list. The right list
displays all results of the control. When recalling results by chemistry, choose a
chemistry in the left list. The right list displays all results of the chemistry.
 Search F1: to recall control results.
 Options F2: to delete or print control samples.
 Reac Data F4: to view the reaction curve of the selected control.
 Print F7: to print control results.
 Host F8: to transmit the selected control results to the LIS host.
Viewing control reaction data

1 Search for desired control results on the Current or History screen.
2 Choose a chemistry in the result list.
3 Select Reac Data F4. The Reaction Data screen is displayed.

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7 Quality Control
Figure 7.14 Control reaction data

 Prev F5 : to view the reaction data of the previous control test.
 Next F6 : to view the reaction data of the next control test.
Printing control results

You are allowed to print the selected or all control results on the Current or History
screen.
1 Search for desired control results on the Current or History screen.
2 To print the selected controls, select them in the sample list.
3 Select Print F7.
4 Select Print Sample Report.
5 Choose the print range:
 Selected Sample(s)
 All Sample(s)
6 If you print all samples, you are allowed to skip those that are already printed out.
Mark the Bypass Printed Sample(s) checkbox.
7 Select OK.
7.6.2 Recalling L-J Chart

A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test results (Y), shows
the QC result trend of a chemistry during the specified period. The graphical trends of up
to 3 controls can be displayed on one L-J chart and distinguished with different colors.
The query date must not be longer than 1 year.
Recalling L-J Chart

1 Select QC - Levey-Jennings.

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7 Quality Control
2 Choose a chemistry to recall in the Chem pull-down list box.

3 Select the date range in the QC Date field.
4 Choose controls you desire to view. Up to 3 controls can be selected.
5 Select Search F1. The L-J chart area shows the QC result trends of the selected
chemistry during the specified period.
Figure 7.15 Levey-Jennings screen

 Prev F4 : to view the L-J chart of the previous chemistry.
 Next F5 : to view the L-J chart of the next chemistry.
 Delete F6 : to delete the selected point on the L-J chart. The deleting operation
will only delete the result flag, and will not delete the actual data. If you want to
display the removed points on the L-J chart, mark the Show Deleted Points
checkbox.
 Print F7 : to print the current L-J chart.
 Comment F8 : to add, modify and delete comments of a QC point.
Adding/Modifying comments
2 Select a chemistry, QC date and controls, and then select Search F1 to query the
corresponding L-J chart.
3 Choose a QC point on the chart.
4 Select Comment F8, and then choose a comment for the QC point.
QC comment can be defined on the Dictionary window.
5 Select OK.

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7 Quality Control
Select the QC point on the chart. The comments of this QC point are displayed in the
Comment area at the upper-right corner of the screen.
To delete the comments of a QC point, select the QC point on the chart, clear the
comments, and then select OK.
Selecting chart option

The L-J chart can be drawn by QC date or QC time. Either of the two options can be
selected to display the L-J chart, in which the X coordinate is displayed by date or time.
The default standard is QC time.
2 Select Chart F3.
Figure 7.16 Chart Options window
3 Choose an option to draw the L-J chart:

 QC Time: The X coordinate of the L-J chart is displayed in the format of
“YYMMDDHHMMSS”.
 QC Date: The X coordinate of the L-J chart is displayed in the format of “MMDD”.
4 Select OK. The L-J chart is refreshed automatically and displayed in the selected
format.
7.6.3 Recalling Twin-Plot Chart

A twin-plot chart, drawn based on the results of control X and control Y in the same run, is
used to detect systematic errors and random errors. It shows the recent 10 QC results of a
chemistry and excludes those that have been deleted.
1 Select QC - Twin-Plot.
2 Choose a chemistry to recall in the Chem pull-down list box.
3 Select Search F1. The twin-plot chart area displays the recent 10 results of control X
and control Y for the chemistry.

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7 Quality Control
Figure 7.17 Twin-Plot screen

 Prev F4 : to view the twin-plot chart of the previous chemistry.
 Next F5 : to view the twin-plot chart of the next chemistry.
 Print F7 : to print the current twin-plot chart.
7.6.4 Recalling QC Data

QC data includes QC results, and the set mean and standard deviation, and can be recalled
by control name, chemistry name and QC date.
1 Select QC - Results.
2 Select Chems F2.
3 Choose a chemistry to recall and then select OK.
5 Select a control in the Control pull-down list.
6 Select Search F1.

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7 Quality Control
The result list shows all results of the control for the chemistry during the specified
period, as well as the set means and standard deviations.
Figure 7.18 Results screen

 Reac Data F4: to view the reaction data of the selected QC result
 Comment F5 : to add comments to the selected QC result.
 Archive F6 : to archive the currently displayed QC results to an external storage
device.
 Print F7 : to print the QC results currently displayed in the result list.
Add QC comments
Comments can be added to specific QC result for special notice.
1 Search for desired QC results on the Results screen.
2 Choose a QC result in the result list.
3 Select Comment F5.
Figure 7.19 Comment window
4 Type in comments for the selected QC result.

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7 Quality Control
Up to 100 characters can be entered.

5 Select OK.
Archive QC Data
The system allows archiving of QC results to a storage device. The file format is CSV and
the default file name is QCData.csv. which cannot be edited. QC results must not be
archived to the hard disk. They can only be archived to external storage device, including
floppy disk.
Perform the following steps to archive QC results and data:
1 Search for desired QC results on the Results screen.
2 Select Archive F6.
Figure 7.20 Archive window
3 Select OK.
7.6.5 Recalling QC Summary

The QC Summary reports the measurements of a control for the selected chemistry
during the specified period. It presents you the means, standard deviations and
coefficients of variation in this period, and compares them with the set mean and SD,
enabling you to check if the system is working normally.
1 Select QC - Summary.
2 Select Chems F2.
3 Choose chemistries to recall and then select OK.
5 Select a control in the Control pull-down list.
6 Select Search F1.

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7 Quality Control
The result summary of the control for the chemistry is displayed on the screen.
Figure 7.21 Summary screen
7 To print the QC summary report, select Print F7.

Operator's Manual
8 Sample Programming and Processing
This chapter provides description of functions and operating instructions about sample
analysis, which include:
 Modifying/Adding samples and chemistries
 Rerunning samples
 Programming diluted samples
 Sample rack programming mode
 Loading/Unloading samples
 Clear sample programming
 Viewing unpositioned samples and assign positions for them
 Release positions
 Customizing sample information
 Customizing patient demographics
 Viewing sample and chemistry lists
 Optimize result display
 Sample results recall
 Viewing test statistics
 Viewing result statistics
 Charge statistics

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8.1 Overview
8.1 Overview
Sample programming can be performed in manual and auto modes, in batch, by
rerunning or adding chemistry and samples, in common or quick STAT mode. Sample
programming through rack supports sequential mode, rack ID mode, and bar code mode.
Chemistries selected for samples include immunoassay, calculations and panels. Samples
can be programmed and analyzed based on the running options. Patient demographics
should be entered during the measurements. The system allows the deletion of
programmed and complete samples.
These functions and operations will be described in detail in the following sections.

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8.2 Sample Programming and Processing

8.2.1 Introduction
Except for analysis of routine samples, you often need to add samples or chemistries to
the programming or rerun an abnormal sample. Samples can be diluted manually or
pre-diluted automatically before being analyzed.
8.2.2 Adding Samples
BIOHAZARD
a doctor.
CAUTION
Adding samples to rack is different in different analysis modes. This section describes
sample adding in details.
Sequential mode
When adding samples in the sequential mode, you should consider if the new sample ID
succeeds the previous one in order to avoid ID and invalid results.
1 Program new samples according to “2.8.1 Programming Routine Samples“.
2 Check that the sample program information is correct.
3 Load added samples to a new sample rack and put the rack into the lane.
To insert STAT samples into STAT samples, you may program them through the STAT
Sample Program window.
4 If the ID number of the added samples succeeds that of the previous samples, select
, and select OK to start analysis.
5 Otherwise, select and click a position on the graphic rack on the Start
Conditions window, enter the start sample ID , and then select OK to start analysis.
Rack ID mode or bar code mode:
New samples can be added at any time in the rack ID mode. Make sure that the added
samples are loaded to the assigned racks and positions.
Before adding samples in the bar code mode, ensure that the sample bar code scanning
and LIS bidirectional communication functions have been enabled, and the bar code on
the sample cups has been applied correctly.
1 Program new samples according to “2.8.1 Programming Routine Samples“.
2 Check that the sample program information is correct.
3 Load added samples to a new sample rack and put the rack into the lane

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4 Select .
8.2.3 Adding/Modifying Chemistries

No matter in which status a sample is, new chemistries can be added, and dilution factors
and replicates can be defined for them. For samples that are programmed but not
analyzed yet, editing the sample information, patient demographics and chemistries is
allowed; for samples in the status of In Progress, Rerun, Incomplete or Complete, the
sample information and chemistries must not be edited, while patient demographics can
be edited and new chemistries can be added.
2 Type in sample ID.
The programming information of the sample is displayed on the screen.
3 Deselect chemistries you won’t run, and then select chemistries you desire to run.
4 Deselect panels you won’t run, and then select panels you desire to run.
5 Choose chemistries and panels to add to the sample.
6 Select Save F8.
7 Select the icon on the upper right corner of the main screen to start the
analysis.
8.2.4 Rerunning samples

Finished samples can be rerun in manual or auto mode. Only chemistries that have been
finished can be rerun. If a chemistry is run for more than one replicate, it cannot be rerun
only when all replicates are finished. Manual rerun is performed on the Abnormal
screen, Current screen and History screen; auto rerun is performed when a result
satisfies the set auto rerun conditions. Samples in all status are allowed for rerunning.
Manual rerun on Currentscreen

1 Select Result - Current or History.
2 Choose the By Sample option.
3 Search for desired sample results.
4 Check the Flag column for flags indicating abnormities.
5 Choose results you desire to rerun.
6 Select Rerun F5.

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Figure 8.1 Rerun window
7 Change the lane number (rack ID) and position number. Quick input is supported.
When you input a number, the system gives a full rack number automatically.
The sample can be rerun in the original position when its rack is not taken out.
8 Choose a sample tube type. The options include micro and standard.
10 Select the Predilution checkbox; if it is selected, the chemistries of the sample will
be diluted before test. If some chemistries of the sample do not need predilution,
please select the blank from the Predilution dropdown box. When the Predilution
box is not selected and if some chemistries need predilution, please select the
Predilution ratio from their corresponding Predilution dropdown box.
11 Select Save.
12 Put the original routine or STAT sample rack to the rack supply unit, or load samples
to the assigned dark blue rerun rack and put the rack into the lane.
13 Select to start the analysis.
Batch rerun on Current or History screen

When recalling results by chemistry on the Current or History screen, you are allowed to
rerun multiple samples of a chemistry that are Complete or Incomplete.
1 Select Result - Currentor History.
2 Choose the By Chemistry option.
4 Choose a chemistry and samples you desire to rerun.
5 Select Rerun F5.

Operator's Manual
Figure 8.2 Rerun window
The window shows the selected chemistry and samples, as well as sample ID, bar
code, predilution factor and off-line dilution factor in previous test.
6 Modify the predilution factor and off-line dilution factor for each sample.
 Predilution factor: select the predilution factor. If predilution is not needed, select
blank from the predilection dropdown box.
 Off-line dilution factor: The input range is 2-9999, and the default is blank.
7 Select OK.
8 Put the original sample rack to the lane,.
NOTE
If rerunning tests in sequential mode, you should load samples in the original order.
No matter having rerunning samples or not, racks within the rerunning range must
be loaded.
9 Select to start the analysis.
Rerun when meeting auto rerun conditions

Once the auto rerun is enabled, the system will check if the result meets auto rerun
conditions. And if it does, the system will rerun the sample.
For more information about auto rerun, refer to 3.2.6 Reference/Critical
RangeSetup(Page 3-12).
1 Select Utility
2 Select Chemistries.
4 Select a chemistry.
5 Select a Rerun Type and input Priority.
6 Select Save F7.

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7 Select Exit F8.
Rerunning abnormal samples:

1 Select Result – Abnormal– Abnormal Status.
2 Select a sample or samples that you want to rerun and click Rerun F5 or Batch Rerun
F5.
The samples programmed for rerunning are displayed on the Rerun Status screen.
Recalling rerun results

The rerun results of a sample are presented on the Rerun Results window, through
which you are allowed to recall all rerun results of the sample and set a rerun result as
the default. Users with sufficient permissions are allowed to delete the rerun results of a
sample.
3 Choose a sample and then a chemistry you desire to recall.
5 Select Recall Rerun Results. The Recall Rerun Results window is displayed.
The screen shows the sample information and all reruns results of the chemistry.
Figure 8.3 Rerun Results window
6 The latest rerun result is the default one. To change the default result, choose a result,
and then select Set Defaults.
The Default column of the result shows Y, which stands for Yes.

Operator's Manual
8.2.5 Programming Diluted Samples

Due to patient specificity, certain results of a sample may be relatively high. In this
condition, you are allowed to rerun the corresponding chemistries by manually or
automatically diluting the sample at certain ratio for some or all of the chemistries. When
a sample is analyzed and a result is beyond the reference range or deemed abnormal, you
are allowed to rerun the corresponding chemistry manually with the sample diluted. For
more information about rerunning, refer to “8.2.4 Rerunning samples“ (page8-4).
You are allowed to set the sample dilution factors when defining a chemistry or
requesting the chemistry for sample analysis. When you set both the off-line dilution
factor and predilution factor when requesting a chemistry, the result will be multiplied
automatically by the two dilution factors.
If the replicates and predilution factor are set for both the sample and the chemistry, the
chemistry will be run based on its own settings instead of those of the sample.
Perform the following steps to run diluted samples.
 ID
 Sample position
 STAT status
 Sample type
 Comment
 Chemistries and panels
3 Set the chemistry options:
 Sample cup
4 Select Save F8.
5 Select the icon to start the analysis.
8.2.6 Sample Analysis Mode

and bar code mode, and only one of the three modes can be used simultaneously.
Sequential mode
In sequential mode, the system aligns sample program information with the
orderly-loaded samples according to the input sample ID, and then analyzes the samples.
Load samples to racks in the order they are programmed, and put the racks into the lane
successively.
Perform the following steps to program single or multiple samples.
Program a single sample:
2 Enter the sample ID.

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 STAT status
 Sample type
 Bar code
 Comment
4 Repeat steps 2 to 3 to program more samples.
5 Load samples to racks in the sample ID order.
6 Put the sample rack into the lanes. Select ,and then select OK to start analysis.
.Batch programming:
2 In Sample ID field, enter the first sample's ID.
 STAT status
 Sample type
 Bar code
 Comment
4 Select Batch F3, enter the sample ID of the last sample, and then select OK.
5 Load samples to racks in the sample ID order.
6 Put the sample rack into the lanes. Select ,and then select OK to start analysis.
Rack ID mode
In rack ID mode, the system aligns sample program information with the loaded samples
according to the input rack ID and position number, and then analyzes the samples.
When loading samples to racks, make sure the rack ID and position number of the
actually-loaded samples is the same with the input one. Racks can be put in any order into
the lane, because the system can identify samples through the rack ID and sample
position.
Perform the following steps to program single or multiple samples.
Program a single sample:
2 Enter the rack ID and position number.
 STAT status
 Sample type
 Bar code
 Comment
4 Select Save F8.

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5 Repeat steps 2 to 4 to program more samples.

6 Load samples to the assigned positions of the assigned racks.
7 Put the racks into the lane.
8 Select .
9 To add samples during analysis, repeat steps 2 to 8.
Batch programming:
2 Enter the rack ID and position number of the first sample.
 STAT status
 Sample type
 Bar code
 Remark
4 Select Batch F3, enter the position number of the last sample, and then select OK.
5 Load samples to the assigned positions of the assigned racks.
6 Put the racks into the lane
7 Select .
8 To add samples during analysis, repeat steps 2 to 7.
Bar code mode

Prior to choosing the bar code mode, ensure that the sample bar code scanning and LIS
bidirectional communication functions have been enabled on your system. The system
scans bar code on sample cups, obtains sample program information from the LIS host,
and then finishes sample programming and processing automatically.
Perform the following steps to analyze samples in bar code mode:
1 Load bar-coded samples to racks.
2 Put the racks into the lane.
3 Select . The system starts scanning the sample bar code, obtaining relevant
program information from the LIS host, and then analyzing the samples.
8.2.7 Sample Management

Before programming samples, it is necessary to understand the sample tubes, sample bar
code and sample volume of the system, as well as how to load and unload samples.
Sample volume
The amount of sample required for a common measurement is 10-200μl, with an
increment of 1μl. Analysis with insufficient samples may lead to inaccurate results.
If a sample is exhausted during the analysis, the system will automatically invalidate all
incomplete chemistry of the sample. Before running samples, make sure that they are
sufficient in volume for analysis.

Operator's Manual
Loading samples to rack
BIOHAZARD
1 Check if the sample inside the sample tube is sufficient for analysis and the bar code
label is applied correctly.
2 Load sample tubes to the racks according to the applied analysis mode.
 Sequential mode: load samples to racks in the order they are programmed.
 Rack ID mode: load samples to the assigned positions of assigned racks.
 Bar code mode: load bar-coded samples randomly to racks.
3 Check the system status.
 If the system status is Running, select to request for rack stop.

 If the system status is Standby, proceed to the next step.
 If the system status is Incubation, wait until the system gets steady, and then
4 Check if the sample track and the probe have stopped moving,
5 Put the racks into the lane according to the applied analysis mode.
 Sequential mode: put the racks successively into the lane in the order the
samples are programmed.
 Rack ID mode and bar code mode: put the racks randomly into the lane.
Unloading samples from rack

When the rack indicator light is green and flashing, take out the racks, and then take out
sample tubes from the racks.

Operator's Manual
8.3 Clear Samples
8.3 Clear Samples

8.3.1 Introduction
The Clear Samples function is used to delete programmed samples that have not been
analyzed. One or more samples can be cleared at one time. When samples are cleared, the
sample information will be removed completely; the sample ID, position and bar code can
be used for programming other samples. The action of clearing samples will be recorded
in the edit logs.
8.3.2 Clearing Samples

2 Select List F5. Select Sample List or Chemistry List. Then select Clear F6.
Figure 8.4 Clear Samples window
3 Type in the sample ID range in the Sample ID field. Single sample ID and sample
range are acceptable
4 Select OK.
The selected samples are cleared along with their programming information

Operator's Manual
8.4 Unpositioned Samples

8.4.1 Introduction
Unpositioned samples are those:
 downloaded from the LIS host and not positioned yet. Such samples cannot be
programmed for analysis until they have positions assigned. If your system is
equipped with a sample bar code reader, the samples can be analyzed immediately
without assigning positions for them.
 that are in Incomplete status when their positions are used for programming new
samples.
 that are incomplete when their positions are released.
Once positioned, the samples will be removed from the unpositioned samples list. In
sequential mode, it is not allowed to assign positions for unpositioned samples on rack.
8.4.2 Assigning Positions

2 Select List F5.
3 Select Assign.
Figure 8.5 Assign Positions
4 Select the program date of sample(s) to assign position.

5 Type in the sample ID or range in the ID field.
6 Enter rack ID in the Rack field.
7 Enter the positions in the Pos field.
 To assign position for single sample, input the position number in the first edit
box.
 To assign positions for multiple samples, enter the start position number in the
first edit box, and then the end position number in the second edit box. The
system will assign positions for the samples ascending according to the sample
ID.

Operator's Manual
 If the available positions among the specified range are more than or equal to
the number of samples, the extra positions will be neglected.
 If the available positions among the specified range are less than the number of
samples, the system will display a message indicating insufficient positions.
Assign the positions again.
8 Select OK.
9 To run the samples, select the icon on the upper-right corner of the main
screen.

Operator's Manual
8.5 Release Sample Position

8.5.1 Introduction
When a sample is analyzed, the position cannot be used for programming new sample
until it is released. Sample positions can be released automatically at specified time
every day. When the set time is reached,
 If the system is shut down, the sample positions in the status of Complete will be
released next time when the system is started up.
 If the system is not running any tests, the sample positions in the status of Complete
will be released.
 If the system status is Running, the sample positions in the status of Complete will be
released when the system status becomes Standby or Failure at the first time.
When a sample is released, its results and programming information can be still recalled.
8.5.2 Releasing Rack Position

Those racks that have finished measurements cannot be used for new samples until they
have been released. Positions can be released in any analysis mode.
1 Access the Release Rack Position window.
Select Program - Sample,and then select Release F4.
Figure 8.6 Release Rack window
2 Select the rack you want to release. Multiple racks can be selected at the same time.
3 Select Release Rack Position to release positions of the selected rack.
8.5.3 Auto Release of Samples

3 Select 8 Auto Release Sample.
4 Type in the auto release time of patient samples in the Auto Release Time field.

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Enter an integer between 00 and 23. The default is 00.

5 Select OK.
When the time is reached, the system will release automatically all sample positions
in the status of Complete.

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8.6 Customizing Sample Information
8.6 Customizing Sample Information

8.6.1 Introduction
The system provides the Cust. Sample Info. option for specifying sample information to be
displayed on the Sample screen. It includes: bar code, sample comment, patient ID,
sample status, and all editable information on the Demographics window like date of
birth, gender, collection time, diagnosis, etc. A maximum of 5 options can be customized
according to their length.
8.6.2 Customizing Sample Information

3 Select 11 Cust. Sample Info.
Figure 8.7 “Customize Sample Information” window
4 Find desired sample information and mark the corresponding Customize checkbox.
Click the checkbox again to deselect it.

5 Select Save.

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8.7 Customizing Patient Demographics
8.7 Customizing Patient Demographics

8.7.1 Introduction
You can specify patient demographics to be displayed, its default and its display order
through the Patient Demographics screen.
8.7.2 Customizing Patient Demographics

3 Select 12 Patient Demographics.
Figure 8.8 Patient Demographics window
4 Select the desired information and the default value and then click Add.
5 Select the desired information and click Delete to delete it from the demographics
list.
6 Select Home, Up, Down and End button to adjust the displayed order of patient
demographics.

Operator's Manual
8.8 Sample and Chemistry Lists

8.8.1 Introduction
The List option allows you to view, inquire and print all unfinished samples, and assign
positions for unpositioned samples. You are also allowed to view the requested
chemistries’ calibration status, reagent status, tests left, and number of requests.
8.8.2 Sample List

Viewing programmed samples
The sample list shows all samples that have been programmed but not analyzed yet.
Samples can be inquired by program date, sample status, ID, or bar code.
2 Select List F5.
Figure 8.9 Sample List tab page
3 Move the scroll bar to view more samples.

4 To print the sample list, select Print F7.
Inquiring samples by program date, sample status or ID

1 Select Search F1 on the Sample List tab page.

Operator's Manual
Figure 8.10 Search window
2 Enter the conditions:

 Select the program date of samples you desire to inquire; and/or
 Select a sample status, which is available in All, Programmed, In Progress,
Incomplete, Complete, and Rerun; and /or.
 Type in the single sample ID or ID range in the Sample ID field.
3 Select OK. All samples that satisfy the conditions are displayed on the screen.
Inquiring a bar-coded sample

1 Select Search F1 on the Sample List tab page.
2 Type in the sample bar code you desire.
3 Select OK. The corresponding sample is displayed on the screen.
8.8.3 Chemistry List

The chemistry list displays the chemistries in the sample order as they are printed, that is,
“routine chemistries – special calculations”. The routine chemistries are arranged as
specified; while the special calculations are displayed in the order they are defined. When
the print order is adjusted, the chemistry list will update accordingly.
To view the summary of chemistries that are requested on the current day or requested
before but not finished yet, perform the following steps:
2 Select List F5.
3 Select the Chemistry List tab.

Operator's Manual
Figure 8.11 Chemistry List tab page
The screen shows all requested chemistries, including the name, calibration status,
number of requests, and tests left.
4 Move the scroll bar to view more chemistries.

5 To print the chemistry list, select Print F7.

Operator's Manual
8.9 Optimizing Result Display

8.9.1 Introduction
Due to low sensitivity of certain reagents, samples with low concentration may have 0 or
negative results, or cannot be represented accurately by results out of measuring range.
To express sample concentration accurately, the system provides the Optimize Result
Display option to customize such results. When less than the low limit of measuring range,
results will show as “< Low limit of measuring range”; when greater than the high limit of
measuring range, they will show as “> High limit of measuring range”; when less than
both the low limit of measuring range and concentration of the lowest-concentration
calibrator, they will show as “< Maximum of the two values”; when greater than the high
limit of measuring range and concentration of the highest-concentration calibrator, they
will show as “> Minimum of the two values”.
Result optimizing will not affect storage, transmission and archiving of results. The
calculations will be calculated with the actual results of relevant chemistries.
Only users who have the permissions of system setup are allowed to optimize result
display.
8.9.2 Optimizing Result Display

3 Select 10 Optimize Result Display.
Figure 8.12 “Optimize Result Display” window
4 Find desired chemistry, and mark the corresponding Low and High checkboxes.

Operator's Manual
Click the checkbox again to deselect it.

 Select Low. When a result is less than the low limit of measuring range or
concentration of the lowest-concentration calibrator, it will show as “< Low limit
of measuring range”, “< Concentration of the lowest-concentration calibrator”, or
“< Maximum of the two values”. This option is selected by default.
 Select High. When a result is greater than the high limit of measuring range or
concentration of the highest-concentration calibrator, it will show as “> High
limit of measuring range”, “> Concentration of the highest-concentration
calibrator”, or “> Minimum of the two values”. This option is selected by default.
5 Select OK.
6 Select Cancel to close the window.

Operator's Manual
8.10 Results Recall
8.10 Results Recall

8.10.1 Introduction
The Results Recall option allows routine samples, STAT samples and controls to be recalled
and handled on the Current or History screen. The Current includes those that are
programmed and analyzed on the current day; the History Results are those
programmed and analyzed before the current day. All results can be recalled by sample or
by chemistry.
After sample analysis, results can be printed out automatically. For setup methods, refer
to “9.2.2 General Print Setup“ (page 9-5).
8.10.2 Displaying Current Results

1 Select Result - Current.
The screen shows all samples and controls that are programmed and analyzed on
the current day. When certain test of a control sample or patient sample triggers a
data alarm, the sample will appear in yellow.
Figure 8.13 Current screen
The sample type includes R, E and C. R stands for routine sample, E for STAT sample,
and C for control. The Host column indicates the transmission status of the sample. Y
means that the sample has been sent to the LIS host, and N means the opposite. The
Print column indicates the print status of the sample. Y means that the sample has
been printed, and N means the opposite.
Samples displayed in the sample list can be sorted by the type, ID, status, position,
completion time, program date/time, host and print fields.

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8.10 Results Recall
 By sample
 By chemistry
3 When recalling results by sample, choose a sample in the left list. The right list
displays all results of the sample. When recalling results by chemistry, choose a
 Search F1 : to inquire sample results.
 Options F2 : to delete, rerun and print samples, recall rerun results, customize
result display options, recalculate results, compensate results and observe result
trend,.
 Demog F3 : to view patient demographics of the sample.
 Reac Data F4 : to view the reaction data of the selected sample.
 Rerun F5 : to rerun a finished sample.
 Review F6 to review the sample result.
 Print F7 : to print sample results.
 HostF8 : to transmit the selected sample results to the LIS host.
8.10.3 Recalling Current Results

Current results can be inquired by sample information and patient demographics, along
with the current date. Whichever status the system is, only one condition is required for
inquiring desired results.
2 Select Search F1.
Figure 8.14 Recall results window
3 Enter one or more search conditions.

4 Select OK. The samples matching the condition are displayed on the Current screen.
5 Select a function button to perform relevant operations.

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8.10 Results Recall
8.10.4 Viewing Abnormal Sample

When the test of a chemistry of a sample has been completed, but no test result is
produced, the sample and its chemistry will be displayed on the abnormal sample screen.
Viewing abnormal samples

Sample ID, bar code, position, chemistry, error code of abnormal samples are
displayed in the list. The list can be sorted by sample ID, chemistry or error code.

 Rerun F5: Select this button to rerun an abnormal sample
 Batch Rerun F6: Select this button to batch rerun multiple abnormal samples.
Rerunning abnormal samples:

2 Select a sample or samples that you want to rerun and click Rerun F5 or Batch Rerun
F5.
Refer to 8.2.4 Rerunning samples(Page 8-4)
The samples programmed for rerunning are displayed on the Rerun Status screen.
8.10.5 Displaying History Results

1 Select Result - History.
Figure 8.15 History screen

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8.10 Results Recall
The screen shows all samples and controls that are programmed and analyzed
before the current day.
The sample type includes R, E and C. R stands for routine sample, E for STAT sample,
and C for control. The Host column indicates the transmission status of the sample. Y
means that the sample has been sent to the LIS host, and N means the opposite. The
Print column indicates the print status of the sample. Y means that the sample has
been printed, and N means the opposite.

 By sample
 By chemistry
3 Select Search F1 to search for desired results.
4 When recalling results by sample, choose a sample in the left list. The right list
displays all results of the sample. When recalling results by chemistry, choose a
 Options F2: to delete, rerun and print samples, recall rerun results, customize
result display options, compensate results and observe result trend.
 Demog F3: to view patient demographics of the sample.
 Reac Data F4 : to view the reaction data of the selected sample.
 Rerun F5: to rerun a finished sample.
 Review F6 to review the sample result.
 Print F7 : to print sample results.
 Host F8 : to transmit the selected sample results to the LIS host.
8.10.6 Recalling History Results

Stored results can be inquired by sample information and patient demographics, along
with the program date. Whichever status the system is, only one conditions is required
for inquiring desired results while the Program Date field can be left blank. To quickly
search for desired results from the tremendous amount of data, you are recommended to
enter both the program date and any of the conditions.
1 Select Result - History.
2 Select Search F1.

Operator's Manual
8.10 Results Recall
Figure 8.16 Recall Results window
3 Select the program date range you want to recall. Select the start date in the first box
and the end date in the second box.
4 Enter one or more search conditions.
5 Select OK. The samples matching the condition are displayed on the screen.
6 Select a function button to perform relevant operations.
8.10.7 Review Sample Results

Only when the sample status is complete, can the sample results be reviewed.
1 Select Result-Current Results or History Results.
3 Choose a sample or more samples in the sample list.
4 Select Review F6.
The review status in the sample list turns from N to Y.
5 Select No Review F6 to cancel the review operation.
8.10.8 Viewing/Editing Patient Demographics

Patient demographics can be viewed or edited in any system status.
2 View the results by samples.
3 Choose desired sample in the sample list. Move the scroll bar on the right of the list
to view more samples.
4 Select Demog F3.

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8.10 Results Recall
Figure 8.17 Demographics window
To customize patient demographics, refer to "8.7 Customizing Patient

Demographics" (page8-18).
5 Enter patient information.

6 Select Save F7 to save your input.
7 Select Prev F4 or Next F5 to view demographics of the previous or next sample.
8.10.9 Reaction Data

On the reaction data screen, you can view information of samples and controls, such as
chemistry information, results information, calibrator and reagent information.
1 Search for desired sample results on the Current or History screen.
 By sample
 By chemistry
3 Choose a chemistry or sample in the result list.
4 Select Reac Data F4. The Reaction Data screen is displayed.

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8.10 Results Recall
Figure 8.18 Sample reaction data
5 Select Prev F5 and Next F6 to view data of other tests.

8.10.10 Transmitting Results to LIS Host

Sample results and QC results can be sent to the LIS host in any system status if the LIS
host is connected correctly. The Host option allows the transmission of single or multiple
samples, or all samples to the LIS host.
2 View the results by samples.
3 To transmit single or multiple sample results, select them in the left list. To transmit
all sample results, do not select.
4 Select Host F8.
Figure 8.19 Transmit Results window
5 Select the sample range you want to transmit:

 selected sample(s)

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8.10 Results Recall
 all samples
6 If you transmit all samples, you are allowed to skip those that are already transmitted
to the LIS host. Mark the Bypass Transmitted Result(s) checkbox.
7 Select OK.
8.10.11 Printing Results

Samples can be printed manually on the Current and History screens. The system allows
multiple samples to be printed on one report or one sample on one report. Before
printing the recalled results, you should select a report template on the System Setup
screen.
The Print option allows single or multiple samples, or all samples to be printed out.
Print by sample
The print by sample option allows you to print the test results of one or more samples
when results are recalled by sample.
1 Search for desired samples on the Current or History screen.
3 To print single or multiple samples, select them in the sample list.
 To select current results, select the first sample, press and hold the Shift key, and
then select the last sample; or select the first sample, press and hold the Ctrl key,
and then select other samples; or press Ctrl + A to select all samples displayed
on the current page. To display the first or last row in the current sample list,
press Ctrl + Home or End.
 To select history samples, directly click the type button of the samples to select
them.
4 Select Print F7.


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8.10 Results Recall
 Selected Sample(s)
 All Samples
7 If you print all samples, you are allowed to skip those that are already printed out.
Mark theBypass Printed Sample(s) checkbox.
8 Select OK.
Print by chemistry
The Print by chemistry option allows you to print the test results of one or more
chemistries when results are recalled by chemistry.
3 To print single chemistry in the chemistry list, select one; to print all chemistries,
there is no need to select them.
4 Select Print F7.

 Selected Chemistry
 All Chemistries
6 Select OK.
8.10.12 Deleting Results

The system has a limited storage capacity and can store 50,000 samples. The results with
the earliest date will be overridden when the capacity is exceeded. The system allows
deleting of routine samples, emergent samples and controls, while they are sent to the LIS
host or printed out. When the system status is Running, samples in the status of Running
cannot be deleted; when the system status is but Running, samples in any status can be
removed. Deleted results cannot be restored. Make sure that you have archived them by
sending them to the LIS host or printed out or in other ways.
Before deleting a result, check if you have sufficient permissions. Only users that have
sufficient permissions are allowed to delete results. The deleting operation will be
automatically recorded in event logs.
 By sample
 By chemistry

Operator's Manual
8.10 Results Recall

4 When recalling results by sample, choose samples in the sample list. When recalling
results by chemistry, choose a chemistry in the left list.
All results of the selected sample or chemistry are displayed on the screen.
6 Select Delete Results.
Figure 8.22 Delete Results window
7 Choose the sample range:

 Selected result(s): to delete the results of the selected samples or chemistries.
 All results: to delete all results on the screen.
8 Select OK.
8.10.13 Customizing Result Display

The Customize Result Display option allows tailoring of sample and result display options
on the Current and History screens. When recalling results by sample, the sample list and
result list can be customized. When recalling results by chemistry, only the result list can
be tailored.
 By sample
 By chemistry
4 Select Customize Result Display.

Operator's Manual
8.10 Results Recall
Figure 8.23 Customize Result Display window – By sample
Figure 8.24 Customize Result Display window – By chemistry
5 If recalling results by sample,

 Choose desired header names in the Sample List Setup area and screens where
they are going to be displayed. Use the Up and Down buttons to adjust the
display order of the header names.
To forbid display of a header name in the sample list, deselect the corresponding
checkbox.
 Choose desired header names in the Result List Setup area and screens where
they are going to be displayed. Use the Up and Down buttons to adjust the
display order of the header names.
To forbid display of a header name in the sample list, deselect the corresponding
checkbox.
6 If recalling results by chemistry,

Operator's Manual
8.10 Results Recall
Choose desired header names and screen in the Result List Setup area. Use the Up
and Down buttons to adjust the display order of the header names.
To forbid display of a header name in the result list, deselect the corresponding
checkbox.
7 Select Save to save the settings and close the window.
8.10.14 Recalculating Results

The Recalculate Results option is used to recalculate current sample results with the latest
valid calibration factors of relevant chemistry. This option is often used when test result
cannot be calculated due to incomplete or failed calibration.
Recalculate Results is only applicable to immunological chemistries. Result of samples in
In Progress status cannot be recalculated. The recalculation will be automatically recorded
in event logs.
3 Select Recalculate Result.
Figure 8.25 Recalculate Results window
4 Choose a chemistry from the Chem pull-down list.

5 Select Calculate.
Results of the selected chemistry for the specified samples are recalculated
automatically with the latest calibration factors and then displayed in the list at the
bottom.

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8.10 Results Recall
8.10.15 Compensating Results

The Compensate Results option is used to recalculate multiple results of certain chemistry
through the linear formula Y=K*X+B with specified slope K and offset B.
Compensate Results is invalid for special calculations. A calculation will be recalculated
automatically once its constituent chemistries are compensated. Only users that have
sufficient permissions are allowed to compensate results. The compensation will be
automatically recorded in event logs.
3 Choose the chemistry that you want to compensate in the left list.
5 Select Compensate Results.
Figure 8.26 “Compensate” window
All results of the chemistry are displayed in the list.

6 Input the slope K and offset B.
7 Select Save.
The system recalculates all results of the chemistry with the specified slope and
offset. The final results are displayed in the list of the window.
8.10.16 Recalling Result Trend

Result trend allows you to observe the result trend of the selected patient.
2 Choose the result recall mode – By chemistry.
4 Choose a sample or a chemistry in the left list.

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8.10 Results Recall
6 Select Recall Result Trend.

Figure 8.27 “Result Trend” window
The result trend curve of the selected chemistry is displayed on the window.
7 Move the cursor to certain point on the graphic trend. The actual result, final result,
completion time, reagent lot number, serial number, and calibration time are
displayed on the right of the window.
8 To show all results of repeated analysis or rerun tests, select the Rerun Result
Statistics checkbox.
9 To observe the results of the chemistry, select Prev F5 or Next F6.
8.10.17 Archiving Results

The system allows archiving of sample results to a storage device. The file format is CSV
and the default file name is SampleResultYYYYMMDD.csv. which cannot be edited. Sample
results must not be archived to the hard disk.
Perform the following steps to archive sample results and data:

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8.10 Results Recall
NOTE
It may take a long time to archive a large amount of results. You are recommended
not to archive results over one week each time.
3 Select 6 Archive.
4 Select OK.

Operator's Manual
8.11 Test Statistics

On the Tests screen, you can view test requests and reagent application for each
chemistry during a period, and you can view sample requests and the quantity of their
chemistries as well. Calibration test and QC test are not included in the statistics.
1 Select Result - Statistics - Tests.
2 Select By Sample or By Test.
Figure 8.28 Tests screen-by sample

Operator's Manual
Figure 8.29 Tests screen-by test
 By Sample: To view all requested samples and the quantity of their requested
chemistries.
 By Test: To view test requisitions and reagent volume for the chemistries
(including immunoassay and calculation tests). "Requested" and "Finished"
quantity does not include requested and finished numbers of calibration and QC
tests.
3 Select or enter the start date and end date in the Program Date field. The start date
cannot be later than the end date.
4 Select Search F1.
All samples or tests requested during the period are displayed in the middle list of the
Tests screen.

Operator's Manual
8.12 Result Statistics

Result statistics option can summarize the total chemistries and the distribution trend of
its results, and provide the test data and graph. Calibration and control test are not
included in the statistics.
1 Select Result - Statistics.
2 Select Results tab.
3 Select Statistic Graph or Statistic Data.
4 Select Search F1 to display the Recall Results window.
Figure 8.30 Recall Results
5 Input one or more search conditions.

6 Select OK.

Operator's Manual
The relevant statistic results are displayed on the screen.:

Figure 8.31 Result statistics screen -statistic graph
Figure 8.32 Result statistics screen -statistic data
7 Select Print F7 to print out the statistic graph and statistic data.

Operator's Manual
8.13 Charge Statistics

On Charge statistics screen ,you can view the charge information in a period of time.
8.13.1 Charge setup

2 Select Charge.
3 Select Charge setup F2.
4 Set the charge for each chemistry.
Figure 8.33 Charge setup window
5 Select OK.
6 Select Cancel to exit the window.
8.13.2 Search charges

2 Select Charge.
3 Select the program time, department and patient type.
4 Select Search F1.
The number of tests and charges for each patient and the total quantity of tests and
the sum of charges are displayed on the screen.

Operator's Manual

Operator's Manual
CL-1000i Chemiluminescence
Immunoassay Analyzer
Operator’s Manual
Volume II
Table of Contents
Intellectual Property Statement ............................................................................................................................................. ii

Responsibility on the Manufacturer Party........................................................................................................................ iii
Warranty ........................................................................................................................................................................................ iv
Exemptions..................................................................................................................................................................... iv
Customer service department ................................................................................................................................ iv
EC - Representative ..................................................................................................................................................... iv
Preface ················································································································· v
Safety Information ··································································································· 1
Safety Symbols .............................................................................................................................................................................. 2

Summary of Hazards .................................................................................................................................................................. 3
Introduction ..................................................................................................................................................................... 3
Electric Shock Hazards ................................................................................................................................................ 3
Moving Parts Hazards .................................................................................................................................................. 3
Sample, Calibrator and Control Hazards .............................................................................................................. 4
Reagent and Wash Solution Hazards .................................................................................................................... 4
Waste Hazards ................................................................................................................................................................ 4
System Disposal Hazards ........................................................................................................................................... 4
Fire and Explosion Hazards ...................................................................................................................................... 4
Removal of Analyzer from Use for Repair or Disposal .................................................................................. 5
Changing Waste Tank .................................................................................................................................................. 5
Precautions on use...................................................................................................................................................................... 6
Introduction ..................................................................................................................................................................... 6
Intended Use ................................................................................................................................................................... 6
Environment Precautions ......................................................................................................................................... 6
Installation Precautions .............................................................................................................................................. 6
Cleaning and Decontamination................................................................................................................................ 6
Electromagnetic Noise Precautions ....................................................................................................................... 7
Operating Precautions ................................................................................................................................................ 8
System Home .................................................................................................................................................................. 8
Maintenance and Servicing Precautions ............................................................................................................. 9
Sample Precautions ...................................................................................................................................................... 9
Reagent, Calibrator and Control Precautions ..................................................................................................10
Rack Feeder System Precautions ..........................................................................................................................10
CL-1000i Chemiluminescence Immunoassay Analyzer I

Operator's Manual
Table of Contents－Volume II
Data Archiving Precautions ....................................................................................................................................10

External Equipment Precautions .........................................................................................................................11
Tube and Liquid Container Precautions ............................................................................................................11
Loading Cuvette ...........................................................................................................................................................11
Instrument Labels and Silkscreen.......................................................................................................................................12
Introduction ...................................................................................................................................................................12
Non-Warning Labels and Silkscreen ...................................................................................................................12
Warning Labels ............................................................................................................................................................15
1 System Description ······························································································1-1
1.1 Installation Requirements and Procedure .............................................................................................................. 1-2

1.1.1 Installation Requirements........................................................................................................................... 1-2
1.1.2 Installation Procedure .................................................................................................................................. 1-5
1.2 Hardware Structure ......................................................................................................................................................... 1-7
1.2.1 System Overview ........................................................................................................................................... 1-7
1.2.2 Sample Handling System.......................................................................................................................... 1-10
1.2.3 Reagent Handling System ....................................................................................................................... 1-12
1.2.4 Sampling System ......................................................................................................................................... 1-14
1.2.5 Substrate System......................................................................................................................................... 1-16
1.2.6 Optical Measurement Reaction system ............................................................................................. 1-19
1.2.7 Dispersion System...................................................................................................................................... 1-20
1.2.8 Cuvette Load and Transport System ................................................................................................... 1-20
1.2.9 Reaction Liquid Mixing System............................................................................................................. 1-22
1.2.10 Operation unit ........................................................................................................................................... 1-23
1.2.11 Output Unit ................................................................................................................................................. 1-23
1.2.12 Accessories and Consumables ............................................................................................................ 1-23
1.3 Optional Modules ........................................................................................................................................................... 1-24
1.3.1 Introduction................................................................................................................................................... 1-24
1.3.2 Touch screen monitor ............................................................................................................................... 1-24
1.3.3 Monitor bracket .......................................................................................................................................... 1-24
1.3.4 Printer ............................................................................................................................................................. 1-24
1.3.5 Built-in sample bar code reader ............................................................................................................. 1-24
1.3.6 Built-in Reagent bar code reader........................................................................................................... 1-24
1.3.7 Other Optional Modules............................................................................................................................ 1-24
1.4 Software Description ................................................................................................................................................... 1-25
1.4.1 Main Screen................................................................................................................................................... 1-25
1.4.2 Function Icons and Program Structure .............................................................................................. 1-27
1.4.3 Using a Mouse .............................................................................................................................................. 1-34
1.4.4 Using a Touchscreen .................................................................................................................................. 1-35
1.4.5 Using Online Help ....................................................................................................................................... 1-36
1.5 System Specifications .................................................................................................................................................. 1-38
1.5.1 Technical specifications ........................................................................................................................... 1-38
1.5.2 Power Supply Requirements.................................................................................................................. 1-40
II CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
1.5.3 Environmental Requirements ................................................................................................................ 1-40

1.5.4 Dimensions and Weight ........................................................................................................................... 1-41
1.5.5 Input device ................................................................................................................................................... 1-41
1.5.6 Output device ................................................................................................................................................ 1-41
1.5.7 Noise and Fuse............................................................................................................................................. 1-41
1.5.8 Communication Interface........................................................................................................................ 1-41
1.5.9 Safety Classification.................................................................................................................................... 1-42
1.5.10 EMC Requirements .................................................................................................................................. 1-42
2 General Operating Procedure ·················································································2-1
2.1 General Operating Procedure ...................................................................................................................................... 2-2

2.2 Check before Powering On ........................................................................................................................................... 2-3
2.2.1 Checking Power Supply .............................................................................................................................. 2-3
2.2.2 Checking Printing Paper ............................................................................................................................. 2-3
2.2.3 Check Waste Tank Connection ................................................................................................................. 2-3
2.2.4 Checking Probes............................................................................................................................................. 2-3
2.2.5 Checking Rack Feeder System .................................................................................................................. 2-3
2.2.6 Checking Cuvette, Wash Buffer, Substrate and Probe Wash Solution....................................... 2-3
2.2.7 Checking Waste Container ......................................................................................................................... 2-3
2.3 Powering on ....................................................................................................................................................................... 2-4
2.3.1 Powering On the System............................................................................................................................. 2-4
2.3.2 Powering On the System after Long Time Shutdown ..................................................................... 2-4
2.3.3 Starting the Operating Software ............................................................................................................... 2-5
2.4 Checking System Status.................................................................................................................................................. 2-6
2.4.1 Check Consumable Status ........................................................................................................................... 2-6
2.4.2 Printer Status ................................................................................................................................................... 2-9
2.4.3 LIS Status ........................................................................................................................................................... 2-9
2.4.4 Checking Analyzer Status............................................................................................................................ 2-9
2.4.5 Checking Alarm Status ............................................................................................................................... 2-10
2.4.6 Checking Reagent/Calibration Status ................................................................................................. 2-11
2.4.7 Checking Maintenance Status ................................................................................................................ 2-12
2.4.8 Checking Subsystems................................................................................................................................ 2-13
2.5 Preparing Reagents ...................................................................................................................................................... 2-16
2.5.1 Prepare Immunoassay Reagents .......................................................................................................... 2-16
2.5.2 Preparing Wash Buffer ............................................................................................................................. 2-19
2.5.3 Loading Wash Solution ............................................................................................................................. 2-20
2.5.4 Loading Substrate ....................................................................................................................................... 2-21
2.5.5 Loading Sample Diluent............................................................................................................................ 2-22
2.5.6 Loading and Retrieving Cuvette Tray ................................................................................................. 2-23
2.5.7 Emptying Solid Waste Container .......................................................................................................... 2-24
2.6 Calibration........................................................................................................................................................................ 2-25
2.7 Quality Control................................................................................................................................................................ 2-26
2.8 Programming routine samples ................................................................................................................................ 2-27
2.8.1 Programming Routine Samples ............................................................................................................ 2-27
2.8.2 Loading Routine Samples ........................................................................................................................ 2-31
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2.8.3 Running Routine Samples ....................................................................................................................... 2-32

2.9 Programming STAT Samples .................................................................................................................................... 2-34
2.9.1 Programming STAT Samples .................................................................................................................. 2-34
2.9.2 Loading STAT Samples .............................................................................................................................. 2-37
2.9.3 Start Analysis ................................................................................................................................................ 2-38
2.10 Test Status and Emergency Stop........................................................................................................................... 2-39
2.10.1 Checking Reagent Status ....................................................................................................................... 2-39
2.10.2 Viewing Consumable Status ................................................................................................................. 2-39
2.10.3 Checking Reagent Overview ................................................................................................................ 2-40
2.10.4 Viewing Status of Racks ......................................................................................................................... 2-42
2.10.5 Emergency Stop ........................................................................................................................................ 2-44
2.11 Daily Maintenance ..................................................................................................................................................... 2-45
2.12 Shutdown and Log Off .............................................................................................................................................. 2-46
2.12.1 Log Off........................................................................................................................................................... 2-46
2.12.2 Shut Down................................................................................................................................................... 2-47
2.13 Check after Powering Off ........................................................................................................................................ 2-48
2.14 Storing the Analyzer after Long Term Shutdown .......................................................................................... 2-49
3 System Setup ·····································································································3-1
3.1 System Setup ...................................................................................................................................................................... 3-2

3.1.1 Introduction...................................................................................................................................................... 3-2
3.1.2 Sample and Test Options............................................................................................................................. 3-2
3.1.3 Instrument Setup Options .......................................................................................................................... 3-3
3.1.4 Print Setup ........................................................................................................................................................ 3-7
3.1.5 Bar Code Setup ................................................................................................................................................ 3-7
3.1.6 Host Communication Setup ....................................................................................................................... 3-7
3.1.7 User Accounts and Permissions ............................................................................................................... 3-7
3.2 Chemistry Setup................................................................................................................................................................ 3-8
3.2.1 Introduction...................................................................................................................................................... 3-8
3.2.2 Editing and Deleting Chemistries ............................................................................................................ 3-8
3.2.3 Define/Edit Chemistries ............................................................................................................................. 3-9
3.2.4 Flag Qualitative Result ............................................................................................................................... 3-11
3.2.5 Slope/Offset Adjustment .......................................................................................................................... 3-11
3.2.6 Reference/Critical RangeSetup ............................................................................................................. 3-12
3.3 Calibration Setup ........................................................................................................................................................... 3-17
3.4 QC Setup ............................................................................................................................................................................ 3-18
4 Operation Theories ······························································································4-1
4.1 Principles of Measurement .......................................................................................................................................... 4-2

4.1.1 Introduction...................................................................................................................................................... 4-2
4.1.2 Sandwich Method .......................................................................................................................................... 4-2
4.1.3 Competitive Method ..................................................................................................................................... 4-3
4.2 Analysis Mode .................................................................................................................................................................... 4-4
4.2.1 Introduction...................................................................................................................................................... 4-4
4.2.2 One-step Method ........................................................................................................................................... 4-4
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4.2.3 Two-step Method........................................................................................................................................... 4-4

4.3 Calibration Math Model ................................................................................................................................................. 4-7
4.3.1 Introduction...................................................................................................................................................... 4-7
4.3.2 Quantitative Calibration Type and Calculation ................................................................................... 4-7
4.3.3 Calculating Cutoff Value for Qualitative Analysis ............................................................................... 4-7
5 Reagents ···········································································································5-1
5.1 Overview.............................................................................................................................................................................. 5-2

5.1.1 Introduction...................................................................................................................................................... 5-2
5.1.2 Reagent/Calibration Screen Overview ................................................................................................. 5-2
5.1.3 Consumable Management Window ........................................................................................................ 5-3
5.2 Customizing Reagent Display ...................................................................................................................................... 5-4
5.2.1 Introduction...................................................................................................................................................... 5-4
5.2.2 Customizing Reagent Information ......................................................................................................... 5-4
5.3 Sorting Reagents ............................................................................................................................................................... 5-5
5.3.1 Introduction...................................................................................................................................................... 5-5
5.3.2 Sorting Reagents............................................................................................................................................. 5-5
5.4 Consumable Inventory Alarm Limits Setup ........................................................................................................... 5-6
5.4.1 Introduction...................................................................................................................................................... 5-6
5.4.2 Setting Up Consumable Inventory Alarm Limits................................................................................ 5-6
5.5 Printing Reagent Information ..................................................................................................................................... 5-7
5.5.1 Introduction...................................................................................................................................................... 5-7
5.5.2 Printing Immunoassay Reagent Information .................................................................................... 5-7
5.5.3 Printing Consumable Information .......................................................................................................... 5-7
5.6 On-line Load of Reagents .............................................................................................................................................. 5-8
5.6.1 Introduction...................................................................................................................................................... 5-8
5.6.2 On-line Load of Immunoassay Reagents and Sample Diluent...................................................... 5-8
5.6.3 On-line Load of Substrate, Wash Solution and Wash Buffer ........................................................ 5-9
5.7 Off-line Load of Reagents ........................................................................................................................................... 5-10
5.7.1 Introduction................................................................................................................................................... 5-10
5.7.2 Off-line Load of Immunoassay Reagent and Sample Diluent .................................................... 5-10
5.7.3 Off-line Load of Substrate, Wash Solution and Wash Buffer ..................................................... 5-10
5.8 On-line Replacement of Reagents ........................................................................................................................... 5-11
5.8.1 Introduction................................................................................................................................................... 5-11
5.8.2 On-line Replacement of Immunoassay Reagent and sample diluent ..................................... 5-11
5.8.3 On-line Replacement of Substrate ........................................................................................................ 5-11
5.8.4 On-line Replacement of Wash Buffer .................................................................................................. 5-12
5.9 Off-line Replacement of Reagents ........................................................................................................................... 5-13
5.9.1 Introduction................................................................................................................................................... 5-13
5.9.2 Off-line Replacement of Immunoassay Reagent and Sample Diluent ................................... 5-13
5.9.3 Off-line Replacement of Substrate, Wash Solution and Wash Buffer ..................................... 5-13
5.10 Loading and Retrieving Cuvette Tray and Emptying Solid Waste Container ..................................... 5-14
5.10.1 On-line Loading and Retrieving Cuvette Tray............................................................................... 5-14
5.10.2 On-line Emptying Solid Waste Container ....................................................................................... 5-14
5.10.3 Off-line Loading and Retrieving Cuvette Tray and Emptying Solid Waste Container .. 5-14
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5.11 Unloading Reagents.................................................................................................................................................... 5-15

5.11.1 Introduction ................................................................................................................................................ 5-15
5.11.2 Unloading Immunoassay Reagents and Sample Diluents ......................................................... 5-15
5.11.3 Unloading Substrate ................................................................................................................................ 5-15
6 Calibration ········································································································6-1
6.1 Overview.............................................................................................................................................................................. 6-2

6.2 Calibration Status and Alarm ....................................................................................................................................... 6-3
6.3 Calibration setup .............................................................................................................................................................. 6-4
6.3.1 Introduction...................................................................................................................................................... 6-4
6.3.2 Define a Calibrator ........................................................................................................................................ 6-4
6.3.3 Input Calibration Master Curve Information ..................................................................................... 6-4
6.3.4 Assign Calibrator Position ......................................................................................................................... 6-5
6.3.5 Select Sample Cup Type ............................................................................................................................... 6-6
6.3.6 Delete Calibrator ............................................................................................................................................ 6-6
6.4 Calibration Options ......................................................................................................................................................... 6-7
6.4.1 Extending Calibration Time ...................................................................................................................... 6-7
6.4.2 Reject .................................................................................................................................................................. 6-7
6.4.3 Individual Bottle Calibration...................................................................................................................... 6-8
6.5 Auto Calibration ................................................................................................................................................................ 6-9
6.5.1 Introduction...................................................................................................................................................... 6-9
6.5.2 Auto Calibration Setup ................................................................................................................................. 6-9
6.5.3 Auto Calibration Reminding ...................................................................................................................... 6-9
6.5.4 Removing Auto Calibration .................................................................................................................... 6-10
6.6 Calibration Test .............................................................................................................................................................. 6-11
6.6.1 Requesting Calibrations ........................................................................................................................... 6-11
6.6.2 Cancel calibration request ...................................................................................................................... 6-12
6.6.3 Loading Calibrator...................................................................................................................................... 6-12
6.6.4 Running Calibrations................................................................................................................................. 6-12
6.7 Recalling Calibration Results .................................................................................................................................... 6-14
6.7.1 Recalling Current Calibration Result .................................................................................................. 6-14
6.7.2 Recalling History Calibration Results ................................................................................................. 6-14
6.7.3 Archiving Calibration Results................................................................................................................. 6-15
6.7.4 Recalling Calibration Data ....................................................................................................................... 6-15
6.7.5 Calibration Trends ...................................................................................................................................... 6-15
7 Quality Control ···································································································7-1
7.1 Overview.............................................................................................................................................................................. 7-2

7.1.1 Introduction...................................................................................................................................................... 7-2
7.1.2 Quality Control Operating Procedure..................................................................................................... 7-2
7.1.3 QC Alarms.......................................................................................................................................................... 7-2
7.1.4 QC result flags .................................................................................................................................................. 7-2
7.1.5 Control Status ................................................................................................................................................... 7-3
7.2 QC Setup ............................................................................................................................................................................... 7-4
7.2.1 Introduction...................................................................................................................................................... 7-4
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7.2.2 Defining/Editing a Control ......................................................................................................................... 7-4

7.2.3 Selection of Chemistries .............................................................................................................................. 7-5
7.2.4 Set Up Control Concentrations ................................................................................................................. 7-6
7.2.5 Assign Control Position ............................................................................................................................... 7-7
7.2.6 Setting Up QC Rules ....................................................................................................................................... 7-8
7.2.7 Deleting a Control........................................................................................................................................... 7-9
7.3 QC Evaluation .................................................................................................................................................................. 7-10
7.3.1 Introduction................................................................................................................................................... 7-10
7.3.2 Evaluation of Single Control .................................................................................................................... 7-10
7.3.3 Two-Control Evaluation ........................................................................................................................... 7-11
7.4 Auto Quality Control ..................................................................................................................................................... 7-13
7.4.1 Introduction................................................................................................................................................... 7-13
7.4.2 Auto QC Setup............................................................................................................................................... 7-13
7.4.3 Auto Quality Control .................................................................................................................................. 7-14
7.4.4 Removing Auto QC Status ........................................................................................................................ 7-14
7.5 QC Test ............................................................................................................................................................................... 7-15
7.5.1 Programming Control Samples ............................................................................................................. 7-15
7.5.2 Loading Control Samples ......................................................................................................................... 7-16
7.5.3 Running Control Samples ........................................................................................................................ 7-17
7.5.4 Auto QC ........................................................................................................................................................... 7-18
7.6 Recalling Control Results ............................................................................................................................................ 7-19
7.6.1 Control Sample Results.............................................................................................................................. 7-19
7.6.2 Recalling L-J Chart ...................................................................................................................................... 7-20
7.6.3 Recalling Twin-Plot Chart........................................................................................................................ 7-22
7.6.4 Recalling QC Data ........................................................................................................................................ 7-23
7.6.5 Recalling QC Summary ............................................................................................................................. 7-25
8 Sample Programming and Processing ········································································8-1
8.1 Overview.............................................................................................................................................................................. 8-2

8.2 Sample Programming and Processing ..................................................................................................................... 8-3
8.2.1 Introduction...................................................................................................................................................... 8-3
8.2.2 Adding Samples ............................................................................................................................................... 8-3
8.2.3 Adding/Modifying Chemistries ................................................................................................................ 8-4
8.2.4 Rerunning samples........................................................................................................................................ 8-4
8.2.5 Programming Diluted Samples................................................................................................................. 8-8
8.2.6 Sample Analysis Mode .................................................................................................................................. 8-8
8.2.7 Sample Management ................................................................................................................................. 8-10
8.3 Clear Samples .................................................................................................................................................................. 8-12
8.3.1 Introduction................................................................................................................................................... 8-12
8.3.2 Clearing Samples ......................................................................................................................................... 8-12
8.4 Unpositioned Samples ................................................................................................................................................. 8-13
8.4.1 Introduction................................................................................................................................................... 8-13
8.4.2 Assigning Positions .................................................................................................................................... 8-13
8.5 Release Sample Position ............................................................................................................................................. 8-15
8.5.1 Introduction................................................................................................................................................... 8-15
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8.5.2 Releasing Rack Position............................................................................................................................ 8-15

8.5.3 Auto Release of Samples ........................................................................................................................... 8-15
8.6 Customizing Sample Information ........................................................................................................................... 8-17
8.6.1 Introduction................................................................................................................................................... 8-17
8.6.2 Customizing Sample Information......................................................................................................... 8-17
8.7 Customizing Patient Demographics ...................................................................................................................... 8-18
8.7.1 Introduction................................................................................................................................................... 8-18
8.7.2 Customizing Patient Demographics .................................................................................................... 8-18
8.8 Sample and Chemistry Lists ...................................................................................................................................... 8-19
8.8.1 Introduction................................................................................................................................................... 8-19
8.8.2 Sample List..................................................................................................................................................... 8-19
8.8.3 Chemistry List .............................................................................................................................................. 8-20
8.9 Optimizing Result Display.......................................................................................................................................... 8-22
8.9.1 Introduction................................................................................................................................................... 8-22
8.9.2 Optimizing Result Display ....................................................................................................................... 8-22
8.10 Results Recall................................................................................................................................................................ 8-24
8.10.1 Introduction ................................................................................................................................................ 8-24
8.10.2 Displaying Current Results ................................................................................................................... 8-24
8.10.4 Viewing Abnormal Sample................................................................................................................... 8-26
8.10.5 Displaying History Results .................................................................................................................... 8-26
8.10.6 Recalling History Results ...................................................................................................................... 8-27
8.10.7 Review Sample Results ........................................................................................................................... 8-28
8.10.8 Viewing/Editing Patient Demographics......................................................................................... 8-28
8.10.9 Reaction Data ............................................................................................................................................. 8-29
8.10.10 Transmitting Results to LIS Host ..................................................................................................... 8-30
8.10.11 Printing Results ...................................................................................................................................... 8-31
8.10.12 Deleting Results ...................................................................................................................................... 8-32
8.10.13 Customizing Result Display ............................................................................................................... 8-33
8.10.14 Recalculating Results ............................................................................................................................ 8-35
8.10.15 Compensating Results ......................................................................................................................... 8-36
8.10.16 Recalling Result Trend ........................................................................................................................ 8-36
8.10.17 Archiving Results ................................................................................................................................... 8-37
8.11 Test Statistics ................................................................................................................................................................ 8-39
8.12 Result Statistics ............................................................................................................................................................ 8-41
8.13 Charge Statistics .......................................................................................................................................................... 8-43
8.13.1 Charge setup .............................................................................................................................................. 8-43
8.13.2 Search charges .......................................................................................................................................... 8-43
9 Data processing ··································································································9-1
9.1 Data Import and Export................................................................................................................................................. 9-2

9.1.1 Introduction...................................................................................................................................................... 9-2
9.1.2 Import/Export Chemistries....................................................................................................................... 9-2
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9.1.3 Data Archive ..................................................................................................................................................... 9-4

9.1.4 Sending Sample Results and QC Results to LIS ................................................................................... 9-4
9.2 Print Setup .......................................................................................................................................................................... 9-5
9.2.1 Introduction...................................................................................................................................................... 9-5
9.2.2 General Print Setup Options ...................................................................................................................... 9-5
9.2.3 Setting up Default Template....................................................................................................................... 9-6
9.2.4 Deleting Template .......................................................................................................................................... 9-6
9.2.5 Editing Print Template ................................................................................................................................. 9-6
9.2.6 Importing Print Template........................................................................................................................... 9-6
9.2.7 Defining Chemistry Print Order ............................................................................................................... 9-7
9.3 Sample Reports .................................................................................................................................................................. 9-9
9.3.1 Introduction...................................................................................................................................................... 9-9
9.3.2 Single Sample Report .................................................................................................................................... 9-9
9.3.3 Multi-sample Report .................................................................................................................................. 9-10
9.3.4 Sample Summary Report ......................................................................................................................... 9-11
9.3.5 Chemistry Summary .................................................................................................................................. 9-12
9.3.6 Sample/Control List Report .................................................................................................................... 9-13
9.3.7 Chemistry List Report ............................................................................................................................... 9-14
10 Chemistries ····································································································10-1
10.1 Special calculations .................................................................................................................................................... 10-2

10.1.1 Introduction ................................................................................................................................................ 10-2
10.1.2 Defining/Editing a Calculation ............................................................................................................ 10-2
10.1.3 Enabling/Disabling Calculations ........................................................................................................ 10-3
10.1.4 Deleting User-Defined Calculations ................................................................................................... 10-4
10.1.5 Running Calculations............................................................................................................................... 10-4
10.2 Panels............................................................................................................................................................................... 10-5
10.2.1 Introduction ................................................................................................................................................ 10-5
10.2.2 Defining/Editing a Panel....................................................................................................................... 10-5
10.2.3 Adjusting Display Order of Panels ...................................................................................................... 10-6
10.2.4 Deleting Panels .......................................................................................................................................... 10-6
10.2.5 Running Panels.......................................................................................................................................... 10-6
10.3 Chemistry Configuration ......................................................................................................................................... 10-7
10.3.1 Introduction ................................................................................................................................................ 10-7
10.3.2 Enabling Chemistry ................................................................................................................................. 10-7
10.3.3 Disabling Chemistries ............................................................................................................................ 10-7
10.3.4 Customizing Chemistry Display Order ............................................................................................. 10-8
10.4 Default Panel ................................................................................................................................................................ 10-9
10.4.1 Introduction ................................................................................................................................................ 10-9
10.4.2 Default Panel .............................................................................................................................................. 10-9
10.4.3 Running Default Panel for Patient Samples ................................................................................... 10-9
10.5 Masking/Unmasking Chemistries .....................................................................................................................10-11
10.5.1 Introduction ..............................................................................................................................................10-11
10.5.2 Masking/Unmasking Chemistries ...................................................................................................10-11
10.6 Version of Closed-Reagent Chemistry ..............................................................................................................10-12
CL-1000i Chemiluminescence Immunoassay Analyzer IX

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10.6.1 Introduction ..............................................................................................................................................10-12

10.6.2 Viewing Version of Closed-Reagent Chemistry ..........................................................................10-12
11 System Setup Options ·······················································································11-1
11.1 Home ............................................................................................................................................................................... 11-2

11.1.1 Introduction ................................................................................................................................................ 11-2
11.1.2 Homing System ......................................................................................................................................... 11-2
11.2 User and password setup ........................................................................................................................................ 11-3
11.2.1 Introduction ................................................................................................................................................ 11-3
11.2.2 Defining a User.......................................................................................................................................... 11-3
11.2.3 Modifying a User....................................................................................................................................... 11-4
11.2.4 Assigning/Modifying Permissions.................................................................................................... 11-4
11.2.5 Deleting User .............................................................................................................................................. 11-5
11.3 Auto Startup .................................................................................................................................................................. 11-6
11.3.1 Introduction ................................................................................................................................................ 11-6
11.3.2 Auto Startup ................................................................................................................................................ 11-6
11.4 Dictionary ...................................................................................................................................................................... 11-7
11.4.1 Introduction ................................................................................................................................................ 11-7
11.4.2 Defining, Editing and Deleting Data Option ................................................................................... 11-7
11.5 Auto Maintenance Setup ......................................................................................................................................... 11-9
11.5.1 Introduction ................................................................................................................................................ 11-9
11.5.2 Auto Maintenance Setup ....................................................................................................................... 11-9
11.6 Software Version .......................................................................................................................................................11-10
11.6.1 Introduction ..............................................................................................................................................11-10
11.6.2 Software version .....................................................................................................................................11-10
11.7 Voice Tone Setup .......................................................................................................................................................11-11
11.7.1 Introduction ..............................................................................................................................................11-11
11.7.2 Importing Audio Files ...........................................................................................................................11-11
11.7.3 Setting Up Voice Tone ...........................................................................................................................11-11
11.8 Sample Analysis Mode Setup ................................................................................................................................11-13
11.8.1 Introduction ..............................................................................................................................................11-13
11.8.2 Sample Analysis Mode Setup..............................................................................................................11-13
11.9 Air Bubble Detection Setup...................................................................................................................................11-14
11.9.1 Introduction ..............................................................................................................................................11-14
11.9.2 Air Bubble Detection Setup ................................................................................................................11-14
11.10 Consumable Check Before Test ........................................................................................................................11-15
11.10.1 Introduction ...........................................................................................................................................11-15
11.10.2 Consumable Check Before Test ......................................................................................................11-15
11.11 Part Setup ..................................................................................................................................................................11-16
11.11.1 Introduction ...........................................................................................................................................11-16
11.11.2 Part setup ................................................................................................................................................11-16
12 Use of Bar Code ······························································································12-1
12.1 Sample Bar Code Reader .......................................................................................................................................... 12-2

12.1.1 Introduction ................................................................................................................................................ 12-2
X CL-1000i Chemiluminescence Immunoassay Analyzer

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12.1.2 Sample Bar Code Setup ........................................................................................................................... 12-3

12.1.3 Programming Bar-Coded Routine Samples ................................................................................... 12-4
12.1.4 Programming Bar-Coded STAT Samples ......................................................................................... 12-4
12.1.5 Adding new samples or chemistries ................................................................................................. 12-5
12.1.6 Results Recall ............................................................................................................................................. 12-6
12.2 Reagent Bar Code Reader ........................................................................................................................................ 12-7
12.2.1 Introduction ................................................................................................................................................ 12-7
12.2.2 Loading Bar-Coded Reagents ............................................................................................................... 12-7
12.3 Bar Code Reader Maintenance .............................................................................................................................. 12-8
12.3.1 Introduction ................................................................................................................................................ 12-8
12.4 Troubleshooting Bar Code Reader........................................................................................................................ 12-9
13 LIS ···············································································································13-1
13.1 Overview ........................................................................................................................................................................ 13-2

13.2 Host Communication ................................................................................................................................................ 13-3
13.2.1 Introduction ................................................................................................................................................ 13-3
13.2.2 Connection between PC and LIS Host.............................................................................................. 13-3
13.2.3 Host Communication Parameters ..................................................................................................... 13-4
13.2.4 Defining Chemistry Code....................................................................................................................... 13-6
13.3 Programming Samples with LIS Host ................................................................................................................ 13-7
13.3.1 Introduction ................................................................................................................................................ 13-7
13.3.2 Programming Functions ....................................................................................................................... 13-7
13.4 Result Transmission.................................................................................................................................................. 13-9
13.4.1 Introduction ................................................................................................................................................ 13-9
13.4.2 Result Transmission Setup................................................................................................................... 13-9
13.4.3 Manually Sending Results to LIS Host ............................................................................................. 13-9
13.5 Troubleshooting LIS ................................................................................................................................................13-10
14 Diagnostics·····································································································14-1
14.1 Overview ........................................................................................................................................................................ 14-2

14.2 Photometer diagnosis .............................................................................................................................................. 14-3
14.2.1 Introduction ................................................................................................................................................ 14-3
14.2.2 Dark Current Count Diagnosis ........................................................................................................... 14-3
14.2.3 Photon Count Diagnosis........................................................................................................................ 14-4
14.2.4 DCF Diagnosis ........................................................................................................................................... 14-5
14.3 Level Sense Diagnosis .............................................................................................................................................. 14-6
14.3.1 Introduction ................................................................................................................................................ 14-6
14.3.2 Level Sense Diagnosis ............................................................................................................................ 14-6
14.4 Dispersion Diagnosis ................................................................................................................................................ 14-8
14.4.1 Introduction ................................................................................................................................................ 14-8
14.4.2 Dispersion Dispense Volume Diagnosis ......................................................................................... 14-8
14.4.3 Dispersion Aspirating Volume Diagnosis....................................................................................... 14-8
14.5 Substrate Dispensing Diagnosis .........................................................................................................................14-10
14.5.1 Introduction ..............................................................................................................................................14-10
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14.5.2 Substrate Dispensing Bubble Diagnosis .......................................................................................14-10

14.5.3 Substrate Dispensing Volume Diagnosis ......................................................................................14-11
14.6 Wash Buffer Dispensing Diagnosis ...................................................................................................................14-13
14.6.1 Introduction ..............................................................................................................................................14-13
14.6.2 Wash Buffer Dispensing Bubble Diagnosis(Inlet tube not empty).....................................14-13
14.6.3 Wash Buffer Dispensing Bubble Diagnosis(Inlet tube empty).............................................14-14
14.7 System Diagnosis......................................................................................................................................................14-15
14.7.1 Introduction ..............................................................................................................................................14-15
14.7.2 System Check ...........................................................................................................................................14-15
15 Maintenance···································································································15-1
15.1 Overview ........................................................................................................................................................................ 15-2

15.1.1 Introduction ................................................................................................................................................ 15-2
15.1.2 Maintenance Consumables .................................................................................................................. 15-2
15.1.3 Tools Required for Maintenance ........................................................................................................ 15-3
15.2 Maintenance Command........................................................................................................................................... 15-5
15.2.1 Introduction ................................................................................................................................................ 15-5
15.2.2 Maintenance Screen Overview ........................................................................................................... 15-5
15.3 Remote Help ................................................................................................................................................................. 15-7
15.3.1 Introduction ................................................................................................................................................ 15-7
15.3.2 Remote Diagnosis and Maintenance................................................................................................ 15-7
15.4 Cloud Web ...................................................................................................................................................................... 15-8
15.4.1 Introduction ................................................................................................................................................ 15-8
15.4.2 Cloud Web.................................................................................................................................................... 15-8
15.5 Scheduled Maintenance ........................................................................................................................................... 15-9
15.5.1 Introduction ................................................................................................................................................ 15-9
15.5.2 Maintenance Schedule ............................................................................................................................ 15-9
15.5.3 Scheduled Maintenance Procedures ................................................................................................. 15-9
15.5.4 Maintenance Log List ...........................................................................................................................15-10
15.5.5 Scheduled Maintenance Screen Overview ...................................................................................15-13
15.6 Daily Maintenance ...................................................................................................................................................15-16
15.6.1 Check Waste Tube/Tank Connection.............................................................................................15-16
15.6.2 Check Consumable Status ....................................................................................................................15-16
15.6.3 Check Syringe ..........................................................................................................................................15-17
15.6.4 Check Probe .............................................................................................................................................15-18
15.6.5 Clean Probe Exterior .............................................................................................................................15-20
15.6.6 Daily Clean .................................................................................................................................................15-22
15.6.7 Effect Check ..............................................................................................................................................15-23
15.7 Monthly Maintenance.............................................................................................................................................15-25
15.7.1 Clean Dust Screens.................................................................................................................................15-25
15.7.2 Clean Wash Wells ....................................................................................................................................15-26
15.7.3 Wipe Dispense Probes/Tubes ..........................................................................................................15-28
15.7.4 Clean Vortexer Hole ...............................................................................................................................15-29
15.8 Three-Month Maintenance ..................................................................................................................................15-31
15.8.1 Wash buffer bubble optical coupler calibration .........................................................................15-31
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15.9 As-Needed/As-Required Maintenance ............................................................................................................15-32

15.9.1 Clean Analyzer Panels ...........................................................................................................................15-32
15.9.2 Clean Reagent Carousel .......................................................................................................................15-33
15.9.3 Replace Syringe .......................................................................................................................................15-34
15.9.4 Clean Probe Interior..............................................................................................................................15-36
15.9.5 Replace Probe ..........................................................................................................................................15-39
15.9.6 Remove Air Bubbles in Syringe ........................................................................................................15-40
15.9.7 Bar Code Maintenance .........................................................................................................................15-42
15.9.8 Discard Cuvettes .....................................................................................................................................15-44
15.9.9 Fluidic Prime ............................................................................................................................................15-45
15.9.10 Clean the Cap of Wash Buffer Tank ..............................................................................................15-46
15.9.11 Clean Dispersion Aspirate Probes ................................................................................................15-47
16 Alarms and Troubleshooting ···············································································16-1
16.1 Classification of Logs ................................................................................................................................................. 16-2

16.1.1 Introduction ................................................................................................................................................ 16-2
16.1.2 Error Log ..................................................................................................................................................... 16-2
16.1.3 Edit Log ........................................................................................................................................................ 16-3
16.2 Viewing and Handling Logs ................................................................................................................................... 16-4
16.2.1 Description of Error Log Screen ........................................................................................................ 16-4
16.2.2 Description of Edit Log Screen ........................................................................................................... 16-4
16.2.3 Recalling Logs ............................................................................................................................................ 16-5
16.2.4 Refreshing Logs ........................................................................................................................................ 16-6
16.2.5 Clearing Logs .............................................................................................................................................. 16-6
16.2.6 Printing Logs .............................................................................................................................................. 16-6
16.3 Error Troubleshooting .............................................................................................................................................. 16-7
16.3.1 Introduction ................................................................................................................................................ 16-7
16.3.2 Error Indications ...................................................................................................................................... 16-7
16.3.3 Identifying Instrument Errors............................................................................................................. 16-8
16.4 Data alarm ...................................................................................................................................................................... 16-9
16.4.1 Introduction ................................................................................................................................................ 16-9
16.4.2 Result Flags ...............................................................................................................................................16-11
16.5 Error Messages and Corrective Actions ..........................................................................................................16-20
17 Template Modifying Software ··············································································17-1
17.1 Main Screen .................................................................................................................................................................. 17-2

17.1.1 Main Screen ................................................................................................................................................ 17-2
17.1.2 File (F) ........................................................................................................................................................... 17-2
17.1.3 Edit (E) ......................................................................................................................................................... 17-5
17.1.4 View (V) ....................................................................................................................................................... 17-5
17.1.5 Insert (I)....................................................................................................................................................... 17-6
17.1.6 Format (M) ................................................................................................................................................. 17-7
17.1.7 Set(S) ............................................................................................................................................................. 17-8
17.1.8 Help (H) ........................................................................................................................................................ 17-9
17.2 Common Tools ...........................................................................................................................................................17-10
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17.3 Draw Tools ...................................................................................................................................................................17-11

17.4 Property Window .....................................................................................................................................................17-13
17.4.1 Page .............................................................................................................................................................17-13
17.4.2 Line ..............................................................................................................................................................17-13
17.4.3 Rectangle ....................................................................................................................................................17-14
17.4.4 Label ............................................................................................................................................................17-15
17.4.5 Text ..............................................................................................................................................................17-17
17.4.6 Title ..............................................................................................................................................................17-18
17.4.7 Image...........................................................................................................................................................17-19
17.5 Report Window .........................................................................................................................................................17-21
Vocabulary ············································································································· 1
Index ···················································································································· 1
XIV CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
9 Data processing
This chapter describes data archiving, print setup, auto print and manual print methods,
and result printouts.
The report examples provided in this chapter are for illustration purpose only. The
reports printed on your instrument shall prevail.

Operator's Manual
9 Data processing
9.1 Data Import and Export

9.1.1 Introduction
The Data Import and Export function allows various data to be imported from or
exported to an external storage device. Exporting chemistries is allowed only when the
system status is Standby, Incubation and Failure.
The following data can be imported:
 chemistries including immunoassay and calculations
The following data can be exported:
 Sample results including results of all replicates: transmitted to the LIS host
 Control results: transmitted to LIS host
 QC Data: archived to external storage device
 Calibration results: archived to external storage device
9.1.2 Import/Export Chemistries

The system supports chemistries to be imported from an external file. If the imported
closed reagents is not necessary, if can be deleted by Delete on the Chemistries-Options
F3 screen. Before the deletion, Ensure the following conditions are met prior to deleting a
chemistry:
 The selected chemistry is not requested or run for samples, calibrators and controls.
 The selected chemistry is disabled.
 The corresponding reagent has been unloaded from the reagent carousel.
Import default chemistry List

Those chemistries imported from the default parameter form can be run only based on
reagents manufactured by our company. Only the print name, result unit, decimal places,
error detection limits, and slope/offset can be modified and deleted, while the others can
only be browsed.
2 Select Import F2.
3 Select Load Default.
All chemistries contained in the default parameter form are displayed in the
Available Chemistries list.
4 Use the following buttons to import desired chemistries:

 Add All>>: add all chemistries in the Available Chemistries list to the
Imported Chemistries list.
 Add ->: add the selected chemistries in the Available Chemistries list to the
 <-Remove: remove the selected chemistries from the Imported Chemistries
list.
 <<Remove All: remove all chemistries from the Imported Chemistries list.

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9 Data processing
5 Select Import.
All imported chemistries are enabled by default and can be used for measurement. If
the result unit is changed, the corresponding chemistry must be recalibrated.
6 Select Exit.
Import specified chemistries list

Only files of . Item format can be imported. A maximum of 500 closed-reagent chemistries
can be imported and configured. Closed chemistry parameters include immunoassay,
calculation, reagent specification, immunoassay calibration, unit, basic parameters and
slope/offset.
When chemistries are imported, they are enabled by default if set up correctly.
Only users with sufficient permission are allowed to import chemistries. Importing
chemistries can be performed only when the system status is Standby, Incubation and
Stop.
CAUTION
While importing chemistries, do not switch off the analysing unit main power or exit the
operating software.
2 Select Import F2.
Figure 9.1 Import Chemistries window
3 Select Load.
4 Locate the path of the parameter form and then select an .item file to import.
5 Select Open.
All chemistries contained in the parameter form are displayed in the Available
Chemistries list.
6 Use the following buttons to import desired chemistries:

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9 Data processing
 Add All>>: add all chemistries in the Available Chemistries list to the
 Add ->: add the selected chemistries in the Available Chemistries list to the
 <-Remove: remove the selected chemistries from the Imported Chemistries
list.
 <<Remove All: remove all chemistries from the Imported Chemistries list.
7 Select Import.
All imported chemistries with correct parameters are enabled by default and can be
used for measurement.
8 Select Exit.
9.1.3 Data Archive

You are recommended to regularly archive the calibration results to an external storage
device, such as U disk and floppy disk
Archiving Calibration Result

The format of the archived calibration results is the same as that displayed on the
software screen including chemistry name, flag, Cal Status, calibration rules, reagent lot
number, serial number and Cal Date/Time. The archiving file is of.csv format and named
by date and time the results are archived.
For more information of archiving calibration results, refer to "6.7.3 Archiving Calibration
Results“(Page 6-15 ).
Archiving QC Data
The QC results and data can be archived to a storage device with the file name of
QCData.csv, which cannot be edited.
For more information of archiving QC data, refer to "Archive QC Data“(Page 7-25 ).
9.1.4 Sending Sample Results and QC Results to LIS

Sample results and QC results can be sent manually or in real-time mode to the LIS host
for reviewing and storage. When a sample is analyzed with its all tests finished, the
system can automatically send the test results to the LIS host; also you are allowed to
search for desired results and then manually send them to LIS.
For more information about sending sample/QC results to LIS, refer to 13.4 Result
Transmission(Page 13-7 ).

Operator's Manual
9 Data processing
9.2 Print Setup
9.2 Print Setup

9.2.1 Introduction
Results and data can be printed out with the specified template through the default
printer. You are allowed not only to set up the printer type and auto print, but also to
define the print order of chemistries.
9.2.2 General Print Setup Options

2 Select Print F3.
Figure 9.2 System Setup Screen
3 Select a report type from the report list on the left of the window.
4 Select a template from the template list.
 The template list includes all the report templates of the selected report type.
 The template list has four columns. Only one template can be selected at the
same time.
5 Setup auto print options:
 Auto print patient reports
 Auto print QC reports
 Auto print calibration reports
 Print Report after Reviewal
6 Choose a printer type.
The system supports three types of printer, which include laser printer, inkjet printer
and stylus printer.
7 Choose a default printer to print reports.

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9 Data processing
9.2 Print Setup
8 Choose a print mode between Paginal and Serial.

9 Select OK.
9.2.3 Setting up Default Template

2 Select Print F3.
3 Select a report type from the Report list on the left of the window.
5 Click Set Defaults to set the selected template in the template list as the default one.
9.2.4 Deleting Template

2 Select Print F3.
5 Click Delete to delete the selected template.
If it is the default one or it has the print duty, it cannot be deleted.
9.2.5 Editing Print Template

2 Select Print F3.
5 Click Edit to open the template modifying software
You can edit the report templates as needed. Refer to 17 Software for details.
9.2.6 Importing Print Template

2 Select Print F3.
3 Click Import to import the print template.

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9 Data processing
9.2 Print Setup
Figure 9.3 Import print template window
4 Select a report type from the factory template dropdown box.

5 Select one or more templates in the template list to be imported.
6 Click Import.
The selected template(s) can be imported
7 Click Customize to import the template you edited from a tmplt file.
The legal directory should be a portable storage device. The templates can be
imported in batch.
8 Click Import
The imported templates will be displayed in the template list.
9 Click Exit to exit the window.
9.2.7 Defining Chemistry Print Order

2 Select Print F3.
3 Select Print Order.

Operator's Manual
9 Data processing
9.2 Print Setup
Figure 9.4 Print Order window
4 Use the following buttons to adjust the chemistry print order:

 Home: to move the chemistry to the first position.
 Up: to move the chemistry to the previous position.
 Down: to move the chemistry to the next position.
 End: to move the chemistry to the last position.
5 Set up result print mode.
 To print results on patient report, select the corresponding Print checkbox.
 To forbid printing results on patient report, deselect the corresponding Print
checkbox or leave it unselected.
6 Select OK to save your settings.
7 To restore chemistry configuration order and print all chemistries on patient report,
select Restore Defaults.

Operator's Manual
9 Data processing
9.3 Sample Reports
9.3 Sample Reports

9.3.1 Introduction
Sample reports are used to print sample results, sample list, reaction curve and data, as
well as sample blank reaction curve and data.
The above-mentioned reports and printing methods are described in detail in the
following sections.
9.3.2 Single Sample Report

A single sample report contains all results of a sample, including emergent sample, routine
sample and control sample. It can be printed out on:
 Current screen
 History screen
Print a single sample report by performing the following steps:
3 Search for desired results to print.
4 Choose a sample.
5 Select Print F7.
Figure 9.5 Print sample results window

7 Select the Selected Sample(s) option button.
8 Select OK.

Operator's Manual
9 Data processing
9.3 Sample Reports
Figure 9.6 Single sample report
9.3.3 Multi-sample Report

A multi-sample report can print two or more samples of a patient on a report. If the
patient demographics of the samples are not consistent, the demographics of the first will
be printed by default. A multi-sample report can be printed out on:
 Current screen
 History screen
Print a multi-sample report by performing the following steps:
4 Choose results to print.
6 Select Print Multi-Sample Report.

Operator's Manual
9 Data processing
9.3 Sample Reports
Figure 9.7 Multi-sample report
9.3.4 Sample Summary Report

Sample Summary Report contains the test results of all patient samples and control
samples for the purpose of archiving and internal audit of the clinical laboratories.
4 Select Print F7.
5 Select Print Report Collection.
6 Select OK.

Operator's Manual
9 Data processing
9.3 Sample Reports
All inquired sample results will be printed out; however, only valid results can be
printed. If a sample has been tested for a same chemistry for several times, the
results of each time will be printed out.
Figure 9.8 Sample Summary Report
9.3.5 Chemistry Summary

Chemistry summary report contains the summary of a chemistry or all chemistries.
4 To print single chemistry in the chemistry list, select one; to print all chemistries,
there is no need to select them.
5 Select Print F7.
6 Choose the print range:

Operator's Manual
9 Data processing
9.3 Sample Reports
 Selected chemistry
 All chemistries
7 Select OK.
Figure 9.9 Chemistry Summary
9.3.6 Sample/Control List Report

A sample/control list report contains all incomplete samples and patient demographics. It
can be printed out on the Sample List screen.
2 Select List F5.
3 Select Print F7. All incomplete samples or controls are printed with the specified
template.

Operator's Manual
9 Data processing
9.3 Sample Reports
Figure 9.10 Sample List
Figure 9.11 Control List
9.3.7 Chemistry List Report

A chemistry list report contains all unfinished chemistries. It can be printed out on the
Chemistry List screen.
2 Select List F5.
3 Select the Chemistry List tab.
4 Select Print F7. All incomplete chemistries are printed with the specified template.
Figure 9.12 Chemistry List

Operator's Manual
10 Chemistries
This chapter introduces applications of chemistries, including:

 Definition and application of calculations
 Definition and application of panels
 Masking and unmasking of chemistries
 Chemistry configuration
 Definition and application of default panels
 Viewing version of closed-reagent chemistries

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10 Chemistries
10.1 Special calculations

10.1.1 Introduction
Calculation of certain chemistries can derive new chemistries of clinical purposes, such as
PSA/FPSA (prostate diagnostics).
A calculation is composed of chemistries, calculation operators and algorithm. Only users
with sufficient permissions are allowed to define, modify and delete calculations. The
system allows a maximum of 50 calculations to be defined.
For the print order of calculations, refer to"9.2.7 Defining Chemistry Print
Order“( Page9-7).
10.1.2 Defining/Editing a Calculation

2 Select Calculations F6.
3 Select Define F1
Figure 10.1 Special calculations window
4 Type in the calculation’s short name in the Chem field.

5 If you are going to use the calculation for analysis, mark the Enable checkbox.
6 Choose a sample type to which the calculation will be applied.
7 Type in the calculation’s full name in the Chemistry field.
8 Type in the print name of the calculation to appear on patient reports.
9 Choose a result unit from the Unit pull-down list.
10 Choose a result precision, that is, the number of decimal places.

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10 Chemistries
The options include:

 0
 0.1
 0.01
 0.001
11 Edit the calculation formula:
 Choose chemistries in the Chemistries list. The chemistries are then displayed
in the Formula field.
 Choose numbers and operators in the Mathematical Symbols area to
constitute the calculation formula along with the chemistries.
 To remove a chemistry, number or operator, move the cursor behind them and
select BS.
 To clear the entire formula, select AC.
12 Select Use Qualitative Result if you want to flag the qualitative results.
For more information, please refer to 3.2.4 Flag Qualitative Result(Page 3-11.)
10.1.3 Enabling/Disabling Calculations

When a special calculation is defined, it is enabled by default and will be calculated for
sample analysis. If a calculation is disabled, it will not be calculated for sample
measurements. Before enabling or disabling a calculation, make sure that the system
status is not Running.
Perform the following steps to enable or disable calculations:
 The calculation list shows all calculations and formulas.
 When the Enable checkbox is marked, it indicates that the calculation will be
included for result calculating.
 When the Enable checkbox is not marked, it indicates that the calculation will
not be included for result calculating.

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10 Chemistries
Figure 10.2 Special Calculations
3 To activate a calculation, mark the Enable checkbox.

4 To inactivate a calculation, deselect the Enable checkbox.
10.1.4 Deleting User-Defined Calculations

Calculations can be deleted by users with sufficient permissions while the system status is
not Running. Only user-defined calculations rather than closed calculations can be deleted.
3 Choose calculations to delete.
4 Select Delete F2.
10.1.5 Running Calculations

Calculations will not be run for calibration, but for quality control and sample analysis
along with other chemistries.
If a chemistry contained in a calculation is run for more than one replicates, the final
result of the chemistry will be used to calculate the result of the special calculation.
NOTE
If QC test is to be performed of the calculation sub-item, make sure that the mean and
standard deviations are set.
If a chemistry contained in a calculation is run for more than one replicates, the final
result of the chemistry will be used to calculate the result of the special calculation.

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10 Chemistries
10.2 Panels
10.2 Panels
10.2.1 Introduction
A couple of chemistries combined together for certain clinical purposes can constitute a
panel, such as: Two semi-hepatitis B and tumor. Panels can help fast programming of
samples.
The panels can be composed of the enabled Immunoassay, excluding the calculation. The
system allows a maximum of 100 panels to be defined. Only users with sufficient
permissions are allowed to define, modify and delete panels.
10.2.2 Defining/Editing a Panel

2 Select Panels F7.
3 Select Define F1.
Figure 10.3 Define/Edit Panels window
4 Type in the panel number.

5 Type in the panel name.
6 Choose panel types.
 Sample: indicates that the panel can be used for sample analysis.
 QC: indicates that the panel can be used for quality control.
At least one panel type must be selected. A panel can be applied to both sample and
control analysis.
7 Choose chemistries for the panel.

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10 Chemistries
10.2 Panels
Select at least a chemistry

8 To remove a chemistry, click it again.
9 Select Save F7.
10 Select Prev F4 or Next F5 to define or edit other panels.
10.2.3 Adjusting Display Order of Panels

Display order of panels on the Sample and Quality Control screens can be adjusted
manually for convenient test requisition.
2 Select Panels F7.
3 Select Up F3 to move the current panel to the previous position, or select Down F4
to move it to the next position.
4 Select Save F7 to save the settings.
10.2.4 Deleting Panels

Panels can be deleted by users with sufficient permissions while the system status is not
Running. When a panel is removed, the chemistries contained in it will still remain and
can constitute panels with other chemistries.
2 Select Panels F7.
3 Choose panels to delete.
4 Select Delete F2.
10.2.5 Running Panels

Panels will not be run for calibration, but for sample and control analysis along with other
chemistries.

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10 Chemistries
10.3 Chemistry Configuration

10.3.1 Introduction
The Chemistry Configuration function is used to enable/disable chemistries that have
been defined correctly and customize their display order on the Sample, STAT Sample
Program and Quality Control screens. When disabled, chemistries will no longer appear
on the Sample, Reagent/Calibration, Quality Control, Define/Edit Panels, Special
Calculations, Current and History screens. Only the enabled chemistries can be
requested for measurements and recalled on results screens.
10.3.2 Enabling Chemistry

All the chemistries can be enabled and disabled. The imported chemistry is configured by
default.
To enable chemistries, perform the following steps:
3 Select Chemistry Configuration.
4 Choose one or more chemistries in the list.
Figure 10.4 "Chemistry Configuration" screen
5 Select OK.
10.3.3 Disabling Chemistries

Some chemistries that will not be used for the moment can be disabled, and will no
longer appear on request screens. Results of disabled chemistries cannot be recalled until
the chemistries are enabled again.
A chemistry can be disabled only if:

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10 Chemistries
 It has no reagent position.

 It has no calibrator position and has not been requested for calibration.
 It has no control position.
 It is not contained in samples and controls that are in Programmed, Incomplete or
Rerun status.
Perform the following procedure to disable chemistries:
3 Select Chemistry Configuration.
4 Deselect the chemistries that you desire to deconfigure.
5 Select OK.
10.3.4 Customizing Chemistry Display Order

Chemistries can be customized to match the test order of your laboratory and will be
refreshed on the request screens. Chemistries on the Chemistry Configuration window
are displayed alphabetically. In the Available Chemistries and Configured Chemistries lists,
click the Chemistry header line to sort the chemistries by name.
To adjust chemistry display order, perform the following steps:
3 Select Display Order
4 Choose a chemistry in the Configured Chemistries list.
5 Use the following buttons to adjust the chemistry’s display order:
 Home: to move the chemistry to the first position.
 Up: to move the chemistry to the previous position.
 Down: to move the chemistry to the next position.
 End: to move the chemistry to the last position.
6 Select OK.
The chemistry list on the request screens are refreshed automatically.

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10 Chemistries
10.4 Default Panel
10.4 Default Panel

10.4.1 Introduction
The system allows a maximum of one default panel to be defined. When a bar-coded
sample has no relevant programming information on the LIS host or has not been
programmed manually, it can be analyzed with the default panel. The default panel is only
applicable to routine and emergent samples, and often used for a tremendous amount of
samples that are analyzed with the same chemistries. The default panel is often used at
nighttime or weekends to avoid complicated chemistry requisition.
Only a sample panel rather than control panel can be set as the default. Default panel is
valid only in bar code mode.
10.4.2 Default Panel

2 Select Panels F7.
3 Select Define F1.
4 Type in the panel name.
5 Choose panel types.
 Sample: indicates that the panel can be used for sample analysis.
 QC: indicates that the panel can be used for quality control.
At least one panel type must be selected. A panel can be applied to both sample and
control analysis.
6 Choose chemistries for the panel.
Select at least a chemistry.
7 Select Save F7.

8 Select Close F8.
9 Select the defined panel in the panel list.
10 Mark the Default checkbox in the same row as the selected panel.
10.4.3 Running Default Panel for Patient Samples
BIOHAZARD
a doctor.
CAUTION
1 Load bar-coded samples to rack.

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10 Chemistries
10.4 Default Panel
2 Select the icon on the upper-right corner of the main screen.

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10 Chemistries
10.5 Masking/Unmasking Chemistries
10.5 Masking/Unmasking Chemistries

10.5.1 Introduction
The chemistry masking function is used when a chemistry needs to be disabled
temporarily due to abnormal result or reagent exhaustion. The marked chemistry will
have a symbol appearing on its upper-left corner, and will still be displayed on the
Sample, Quality Control and Reagent/Calibration screens.
In any system status chemistries can be masked or unmasked. Any users are allowed to
mask or unmask chemistries.
If a sample contains masked chemistries, it will enter the Incomplete status when finished;
if chemistries are unmasked while the sample status is Programmed, the they will be run
along with other chemistries; if chemistries are unmasked while the sample is being
analyzed, they will be added automatically to the analysis; if chemistries are unmasked
after the sample is analyzed, they will be run automatically when analysis begins next
time.
10.5.2 Masking/Unmasking Chemistries

1 Select Utility-Chemistry.
3 Select Mask/Unmask Chem or click the analyzer icon on the main screen, and then
select Mask Chem F3 on the System Status screen.
Figure 10.5 Mask/Unmask Chemistries window
4 Choose chemistries to mask, select OK.

5 To unmask chemistries, select them and then select OK.

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10 Chemistries
10.6 Version of Closed-Reagent Chemistry
10.6 Version of Closed-Reagent Chemistry

10.6.1 Introduction
The system allows viewing of generation tool version and file version of closed-reagent
chemistries that have been imported.
10.6.2 Viewing Version of Closed-Reagent Chemistry

3 Select Version Info.
Figure 10.6 Version info window
4 Select OK.

Operator's Manual
11 System Setup Options
This chapter provides descriptions of system advanced setup options.

The advanced setup options include:
 User and password setup
 System timers for auto startup
 Data dictionary setup
 Auto maintenance setup
 Software version
 Voice tone setup
 Sample analysis mode setup
 Substrate air bubble detection
 Consumable check before test

Operator's Manual
11.1 Home
11.1 Home
11.1.1 Introduction
The Home command is used to initialize the analyzer and rack feeder system, and to
recover them from failures, making all components return to the home positions. The
analyzer and rack feeder system can be homed independently. When the Home command
is executed, the system status becomes Standby.
Prior to homing the system, ensure that the sample track has been cleared of racks.
11.1.2 Homing System

1 Select the icon of the analyzer to enter the system overview screen.
2 Select Home F4.

Operator's Manual
11.2 User and password setup

11.2.1 Introduction
Users can be defined, deleted or modified on the User and Password window. The system
allows up to 100 users to be defined and belonged to two user groups: administrator and
operator. Administrators are allowed to assign permissions for operators.
Figure 11.1 User and Password Setup window
NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when logging
on the system for the first time in order to prevent others from abusing the privileges of
the administrator.
If an operator forgets his password, he may ask the administrator to log on the system
and delete the username and then redefine a username; or he may contact our customer
service department or your local distributor. If the administrator forgets his password,
11.2.2 Defining a User

Only administrators are allowed to define users. Up to 100 users are allowed, including
administrators. You should enter the username, password, confirm password and user
group when defining a user.
2 Select User F6.
3 Enter the username.
4 Enter the password.
A maximum of 20 characters can be entered.
5 Enter the password again in the Confirm field.

6 Choose a user group in the User Group pull-down list.

Operator's Manual

 Administrator
 Operator
7 Select a doctor from Associated Doctor pull-down list.
When the user and the associated doctor have been set up, the default operator in
the patient demographics is the associated doctor of the current login user.
8 Select New. The defined user appears in the user list.
11.2.3 Modifying a User

Only administrators are allowed to edit the user group of themselves and other users.
Username and password can only be modified by the user himself rather than anyone
else.
2 Select User F6.
3 Choose a user to edit in the user list.
4 Enter the new username.
5 Enter the new password.
6 Enter the new password again in the Confirm field.
7 Choose a user group in the User Group pull-down list.

 Administrator
 Operator
8 Choose a doctor associated with the current login user.
9 Select Modify.
11.2.4 Assigning/Modifying Permissions

Permissions are assigned to user groups, which include administrator and operator.
Administrators are allowed to use, assign and modify all permissions that are assigned
for operators; while operators are only allowed to use common functions, such as
assigning reagent position; programming samples, controls and calibrators; recalling
sample/QC/calibration results; and those assigned by the administrators.
2 Select User F6.
3 Choose a user you desire to set up permissions in the user list, and then select
Permission.

Operator's Manual
Figure 11.2 Permission assignment
4 Assign permissions for the selected user.

 To assign new permissions, select the box in front of the relevant operation. The
select button changes to Yes.
 To cancel permissions, deselect the box in front of the relevant operation. The
select button changes to No.
11.2.5 Deleting User

The username that has been used to log on the system currently cannot be deleted. Only
the administrators are allowed to delete users.
2 Select User F6.
3 Choose a username in the user list.
4 Select Delete.
5 Select OK.

Operator's Manual
11.3 Auto Startup
11.3 Auto Startup

11.3.1 Introduction
The Auto Startup Setup option allows to define date and time of starting up the system.
When the time is reached, the system will be started up automatically if it is off.
11.3.2 Auto Startup
NOTE
After setting up the auto start-up time, ensure that the operation unit and the analyzer
are connected to power supply; otherwise, they cannot be started up automatically.
3 Select 1 Auto Start-up.
Figure 11.3 Auto Startup Setup window
4 Choose the weekday for auto startup, and then set up the specific time.
Any time within a week(from Monday to Sunday) can be defined for the system to
start up automatically.
5 Select Save.
When the date and time is reached, the system will be started up automatically no
matter if it is off.
6 Select Exit.

Operator's Manual
11.4 Dictionary
11.4 Dictionary
11.4.1 Introduction
The Dictionary option is provided for setting up and managing frequent data information.
A maximum of 30 data options can be defined for each dictionary, and each dictionary
must not contain duplicate data. Sample comment can be entered manually or selected
from the Comment pull-down list on the Sample screen, Levey-Jennings screen, and
(QC) Results screen.
Data options can be defined, edited or deleted in any system status. The default data
options cannot be deleted or edited.
11.4.2 Defining, Editing and Deleting Data Option

3 Select 2 Dictionary.
Figure 11.4 Dictionary window
4 Choose desired dictionary in the Data list.
To add a data option:

 Select New.
 Input the data name in the Data field.
 Input the symbolic character for the data.
 Input the data description.
 Select Save.

Operator's Manual
11.4 Dictionary
To modify a data option:

 Select desired data option in the data list.
 Modify the data name in the Data field.
 Input the symbolic character and data description.
 Select Save.
To delete a data option:

 Select desired data option in the data list.
 Select Delete.
5 Select Close.

Operator's Manual
11.5 Auto Maintenance Setup
11.5 Auto Maintenance Setup

11.5.1 Introduction
Auto Maintenance Setup is used to set up the interval of effect check ,the start time of
daily clean and Daily clean completed before test.
11.5.2 Auto Maintenance Setup

3 Select 5 Auto Maintenance Setup.
Figure 11.5 Auto maintenance setup window
4 Select Effect Check checkbox and set the interval to perform effect check.
5 Select Daily Clean checkbox and set the start time to perform daily clean.
6 Select Daily Clean completed before test checkbox .Only after daily test is
completed, can the test start.
7 Select OK.
8 Select Exit.

Operator's Manual
11.6 Software Version
11.6 Software Version

11.6.1 Introduction
You are allowed to view the version number of the operating software and database in
any system status.
11.6.2 Software version

3 Select 6 Version Info
Figure 11.6 "Software Version" window
4 View the version number of the operating software and database.

5 Select Details to the right of Control Software to view version of each control
module.

Operator's Manual
11.7 Voice Tone Setup

11.7.1 Introduction
The Voice Tone Setup option provides voice tone choices for system failures or user’s
mis-input or mis-operation. You are allowed to import audio files from an external
storage device and set them as voice tone.
Alarm refers to sound gives out by the system. Beep refers to the sound indicating illegal
input or operation which requires the user's attention and Beep volume can be adjusted
manually according to the practical conditions of the environment. Drag the slider in the
Alarm Volume and Beep Volume field horizontally. The scale is ascending from left to
right. When the slider is moved to the leftmost position, the alarm buzzer is silenced.
Since the Win 8 system does not support buzzer alarm, thus the computer configured
with the analyzer must be equipped with sound card, otherwise the alarm and beep will
not give out.
11.7.2 Importing Audio Files

1 Select Utility-System.
3 Select 9 Voice Tone Setup.
4 Select Import.
5 Select the path and one or more favorite audio files.
6 Select Open.
The imported audio files are displayed in the Alarm and Message Tip pull-down lists.
11.7.3 Setting Up Voice Tone

3 Select 9 Voice Tone Setup.
Figure 11.7 "Voice Tone Setup" window

Operator's Manual
4 Choose a voice tone from the pull-down list box, and then select the corresponding
Test button to test the voice effect until the proper one is found.

Operator's Manual
11.8 Sample Analysis Mode Setup
11.8 Sample Analysis Mode Setup

11.8.1 Introduction
and bar code mode, and only one of the three modes can be used simultaneously. Routine
sample and STAT sample share the same analysis mode.
Before changing the analysis mode, ensure that the system status is Standby or Stopped.
11.8.2 Sample Analysis Mode Setup

3 Select 14 Analysis Mode.
Figure 11.8 Sample Analysis Mode window
4 Choose an analysis mode from the following options. The default is Sequential Mode.
 Sequential mode
 Rack ID mode
 Bar code mode

Operator's Manual
11.9 Air Bubble Detection Setup
11.9 Air Bubble Detection Setup

11.9.1 Introduction
Air Bubble Detection Setup is used to enable or disable substrate aspirating/dispensing
optical coupler test, aspirating/dispensing optical coupler calibration and wash buffer
bubble detection.
11.9.2 Air Bubble Detection Setup

3 Select 18 Air Bubble Detection Setup.
Figure 11.9 Air Bubble Detection setup window
4 Enable or disable. substrate aspirating/dispensing coupler test,

aspirating/dispensing coupler calibration and wash buffer bubble detection.
5 Select OK.

Operator's Manual
11.10 Consumable Check Before Test
11.10 Consumable Check Before Test

11.10.1 Introduction
Consumable Check Before Test is used to disable or enable checking of consumable
inventory, expiration date or calibration status before test.
11.10.2 Consumable Check Before Test

3 Select 19 Consumable Check Before Test.
Figure 11.10 Consumable Check Before Test
4 Select the options.

5 Select OK.

Operator's Manual
11.11 Part Setup
11.11 Part Setup

11.11.1 Introduction
Part setup is used to view the version of substrate syringe and peristaltic pump.
11.11.2 Part setup

3 Select 20 Part setup.
Figure 11.11 Part setup
4 View the version of substrate syringe and peristaltic pump.

5 Select Exit.

Operator's Manual
12 Use of Bar Code
The setup and operation instructions of the sample bar code reader and the reagent bar
code reader are depicted in this chapter. The sample bar code reader is used to identify
samples and obtain sample information by scanning the bar code label applied on sample
tubes. The reagent bar code reader scans the bar code labels automatically when the
reagents are loaded.

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12 Use of Bar Code
12.1 Sample Bar Code Reader

12.1.1 Introduction
The sample bar code system consists of the sample rack bar code system and sample tube
bar code system. The bar code on sample racks is scanned by the bar code reader in the
rack feeder system to obtain rack type and rack ID. Sample tube bar code is applied to
sample tubes on sample carousel and rack. By scanning sample bar code on sample tubes,
sample information can be obtained. The bar code reader in the rack feeder system is
standard configuration. When bar-coded samples are loaded to a rack, the system will
make a full scan and locate samples through the bar code.
Sample rack bar code

Sample rack bar code has been applied on racks when the racks leave the factory. When
sample rack bar code label is damaged and cannot be read normally, it should be replaced
immediately.
Table 12.1 Sample rack bar code specifications
Name Description
Bar code The bar code consists of 5 characters: XXXXX.
The numbers indicate rack ID. For example,
N0001 refers to No.1 sample rack.
Application Sample rack bar code label should be applied on
requirements the front side of rack, facing the sample bar
code reader and level to the top of rack. Make
sure that the rack ID label is oriented towards
the heading direction of rack.
Sample tube bar code specifications

Table 12.2 Sample tube bar code specifications
Name Description
Symbology Codabar, ITF, Code128, Code39, UPC/EAN, and Code93
Minimum bar code 0.19mm
density
Length 3-27 digits
Format and content User-defined
Maximum width 65mm
Minimum height 10mm
Maximum inclination ±5º
angle
Print quality No less than Class C according to the ISO/IEC 15416.
Width and narrowness 2.5-3.0:1
Print paper Coated paper or matte paper. Printing bar code on
common paper may result in vague bar code or degraded
bar code label. You are not suggested to print bar code on
common print paper.

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12 Use of Bar Code
Name Description
Characters Meaningful characters, such as numbers (0~9) and
upper-case letters (A~Z). You are recommended to print
the check digit in order to check that a bar code is read
accurately.
Information contained in a sample tube bar code

The system will obtain the following information from the LIS host based on sample tube
bar code:
 Sample category
 Test date/time
 Sample ID
 Sample type
 Panel No.
12.1.2 Sample Bar Code Setup

2 Select Bar Code F4.
3 Choose Sample Bar Code.
4 Choose a bar code symbology and set up the check digit status.
The following symbologies are provided:

 Codabar
 Interleaved 2 of 5
 Code128
 Code39
 UPC/EAN
 Code93
Code 128, Code 93 and UPC/EAN requires a check digit by default, and other
symbologies are not compulsive. The Code 128 is selected by default and cannot be
modified.
CAUTION
You are recommended to enable the check function for all symbologies in order to
prevent misreading of bar code.
5 Select the option: Auto Number Scanned Samples.

When selected, the system automatically number the samples which do not have
sample ID. The start ID is the number available after last sample programming. Auto
Number Scanned Samples is selected by default.
6 Define the bar code digits.
The system can scan a sample bar code of fixed length or within 3-27 digits. The
Interleaved 2 of 5 only supports bar code of even number length.
 To use a fixed-length bar code,

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12 Use of Bar Code
 Mark the Fixed Digits checkbox of relevant symbology.

 Type in the number of digits in the edit box to the right of the Fixed Digits
field.
To use a sample bar code within 3-27 digits, you have no need to define the fixed
digits
7 Select OK.
8 Select Cancel to exit the window.
12.1.3 Programming Bar-Coded Routine Samples

Program bar-coded routine samples by choosing an operating procedure according to the
facilities in your laboratory.
BIOHAZARD
a doctor.
CAUTION
NOTE
When manually entering sample program information in bar code mode, ensure that the
input program information is consistent with the samples loaded to the sample carousel.
After the manually programmed samples are analyzed, they must be released manually
to leave space for other samples.
When a LIS is provided

1 Place the bar-coded samples in idle positions of rack and place the rack to the lane.
The system starts scanning the samples on the rack and then analyzes them
according to the program information downloaded from the LIS host.
12.1.4 Programming Bar-Coded STAT Samples

STAT sample program allows emergent samples to be programmed and analyzed with
high priority. The system provides common STAT and quick STAT program. Common
STAT program is of higher priority than routine samples. Quick STAT program is mainly
used to program emergent samples quickly with higher priority than routine samples.
Common STAT samples can be analyzed automatically by means of the sample bar code
system and the LIS. Quick STAT samples, however, can only be analyzed by selecting the
icon at the upper-right corner of the main screen. Refer to Quickly Programming
STAT Samples (Page 2-36) for details.

Operator's Manual
12 Use of Bar Code
BIOHAZARD
a doctor.
CAUTION
1 Place the STAT samples stuck with bar code into empty position in the sample rack,
and then place the sample rack into the lane;
The system starts scanning the samples on the rack and then analyzes them
according to the program information downloaded from the LIS host.
12.1.5 Adding new samples or chemistries
BIOHAZARD
a doctor.
CAUTION
2 Select List F5.
3 Select Download F3.
4 Choose one of the following options:
 All programmed samples: to download all samples programmed on the current
day.
 Latest samples: to download samples that are programmed on the current day
but have not been downloaded.
 Sample with the following IDs: to download samples with the specified program
date and ID. Type in the single sample ID or ID range in the edit box.
 Sample with the following bar code: to download the sample with the specified
bar code. Enter the bar code of the desired sample.
5 Select OK.
6 To analyze samples on rack, select the icon on the upper-right corner of the
main screen to request for rack stop;
7 Place the bar-coded samples on the idle positions of the sample rack.

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12 Use of Bar Code
12.1.6 Results Recall

Displaying Current Results
1 Select Result-Current.
The screen shows all programmed and analyzed on the current day.
2 Choose a sample in the left list. The right list displays all results of the sample.
 Search F1: to inquire sample results.
 Options F2: to delete, rerun and print samples, recall rerun results, customize
result display options, recalculate results, compensate results and observe result
trend,.
 Demog F3: to view patient demographics of the sample.
 Reac Data F4: to view the reaction data of the sample.
 Rerun F5: to rerun a finished sample.
 Review F6: to review the sample results.
 Print F7: to print sample results.
 Host F8: to transmit the selected sample results to the LIS host.
12.1.7 Recalling Current Results

Current results can be inquired by sample type, patient name, patient ID, sample ID or
sample bar code, along with the program date. Whichever status the system is, only one
condition is required for inquiring desired results.
You are allowed to view patient demographics, reaction data, to delete results, to send
results to the LIS host, and to print the results. For more information, refer to 8.10 Results
Recall (page8-24).

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12 Use of Bar Code
12.2 Reagent Bar Code Reader
12.2 Reagent Bar Code Reader

12.2.1 Introduction
The reagent bar code reader obtains reagent information from the bar code label. When
bar-coded reagents are loaded to the reagent carousel, the system will make a full scan
and obtain reagent information from the bar code labels.
Reagent bar code specifications

Mindray cryptographic bar code.
Information contained in a reagent bar code

The system will obtain the following information from a reagent bar code:
 Chemistry name
 Lot number
 Serial number
 Expiration date (YYMM)
The reagent information obtained from a bar code label cannot be modified.
12.2.2 Loading Bar-Coded Reagents

Both open reagents and closed reagents can be loaded through bar code scanning.
When loading bar-coded reagents, put them on the reagent carousel. The system will scan
all reagent positions automatically and obtain reagent information from the bar code
label. The information obtained from a reagent bar code include chemistry name,
expiration date, lot number and serial number which cannot be modified except for the
reagent position and bar code.
Reagents are identified through bar code scanning with reagent information obtained, all
of which can only be viewed and cannot be edited.
The bar code scanning is only applied to immunoassay reagent and sample diluent.
WARNING
BIOHAZARD
may be caused.
For details of loading bar-coded reagents, refer to Auto (page2-18).

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12 Use of Bar Code
12.3 Bar Code Reader Maintenance
12.3 Bar Code Reader Maintenance

12.3.1 Introduction
The sample and reagent bar code readers are located inside the analyzer and need not to
be maintained. You are only required to regularly check the bar code scanning windows in
reagent compartment and bar code scanning channel of rack feeder system, and clean
them if dusts or other stains, such as sample and reagent, accumulate.

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12 Use of Bar Code
12.4 Troubleshooting Bar Code Reader

For troubleshooting methods of the bar code reader, refer to 16 Alarms and
Troubleshooting (Page 16-1).

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12 Use of Bar Code

Operator's Manual
13 LIS
This chapter contains communication parameter setup of LIS as well as sample analysis
and result transmission when an LIS is connected.

Operator's Manual
13 LIS
13.1 Overview
13.1 Overview
The chapter provides detailed description of the LIS and Remote Help.
Laboratory Information System (LIS) is an external host computer connected with the
analyzer through a fixed interface. The LIS is used to download sample program
information to the analyzer and receives results sent from the analyzer.
You should set up the communication parameters and results transmission methods prior
to using the LIS host.
Check that your analyzer is equipped with a LIS. If needed, contact our customer service

Operator's Manual
13 LIS
13.2 Host Communication

13.2.1 Introduction
The host communication parameters, such as transmission mode, IP address and port,
should be set up prior to use of the LIS host. To download sample program information
from or sent results to the host, you need to set up the chemistry code used for
identification of chemistries on both the LIS host and the analyzer, which, otherwise,
cannot identify the chemistries simultaneously.
13.2.2 Connection between PC and LIS Host

Follow the procedure below to set up the IP address for connecting the operation unit PC
with the LIS host.
3 Select 3 Com Setup. The System Communication window is displayed.
Figure 13.1 System communication setup
4 Select PC and LIS (selected by default).

5 Choose a network connection in the Network Adapter area.
6 Set up the connection between operation unit and LIS.
 Auto Obtain IP Address(selected by default), or
 Following IP Address: type in the IP Address, Subnet Mask and Default
Gateway for connecting the operation unit with the LIS host.
7 Select Apply.
Check the network cable connection and click OK to save the settings.

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13 LIS
13.2.3 Host Communication Parameters

2 Select Host F5. The Host Communication Parameters window shows.
Figure 13.2 Host communication Parameters window
3 Set up the following parameters:

Table 13.1 Host communication parameters
Transport Choose a transport mode from the Transport Mode pull-down
list. The options include Serial and TCP/IP. The default is
Serial.
IP address Enter the IP address of the LIS host. The connection between
the analyzer and the LIS host is based on the network, i.e.
TCP/IP protocol.
Port Enter the interface number of the LIS host.
Serial If you choose Serial as the transport mode, set up the
communication following parameters:
parameters  Serial port: The default is COM1.
 Data bits: 7 or 8. The default is 8.
 Stop bits: 1 or 2. The default is 1.
 Parity: None, Odd, or Even. The default is None.
 Baud rate: 300, 1200, 2400, 4800, 9600, or 19200. The
default is 9600.
Protocol Choose a protocol for connection between the analyzer and
the LIS host from the Protocol pull-down list. The options
include HL7 and ASTM 1394.
Mode Choose a data transmission mode for the analyzer and LIS
host. The available options are Unidirectional and

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13 LIS
Bidirectional.
 Unidirectional: You are only allowed to send results and
patient demographics to the host rather than downloading
sample programs from it.
 Bidirectional: You are allowed to send results and patient
demographics to the host and downloading sample
programs from it.
Timeout Enter the timeout limit for querying the LIS host. The input
range is 30s-60s, and the default is 30s.
If the timeout limit is exceeded when you attempt to
download sample programs from, or send results to, or
connect the analyzer with the LIS host, the system will give
an alarm indicating communication timed out.
Auto Connect to When the checkbox is selected, the system will connect to
LIS the LIS host automatically when started up.
Retry after When the checkbox is selected, the system will try to
Disconnection reconnect the LIS host for every set interval once the
connection is interrupted.
Interval Input the time interval for which the system will try to
reconnect the LIS host for every set interval once the
connection is interrupted. The default is 30 seconds.
Send Complete When the checkbox is selected, the system will automatically
Samples send results to the LIS host after a sample changes from In
Progress to Complete. This function is only applicable to
samples analyzed on the current day rather than those
analyzed before.
Send When the checkbox is selected, the system will automatically
Incomplete send results to the LIS host after a sample changes from In
Samples Progress to Incomplete. This function is only applicable to
samples analyzed on the current day rather than those
analyzed before.
Advanced Select Advanced. The Advanced window appears, providing
options the following options:
 Send Programmed Samples: When the checkbox is
selected, the system will automatically send the program
information to the LIS host once a single or batch routine
and STAT samples are programmed. Note: This option is
only used for internal software of the manufacturer, and it
should not be used by the user.
 Rerun Finished Chemistries When Downloaded: When
the checkbox is selected, chemistries that have been
finished will be rerun if downloaded again. If this option is
not selected, they will be neglected.
 Send Actual Results and Rerun Results: When the
checkbox is selected, all actual results and rerun results of
each chemistry will be sent to the LIS. If this option is not
selected, only the default result will be sent.
 Bypass Results Beyond Measuring range: When the
checkbox is selected, those results that are beyond the
measuring range will not be sent to the LIS. If this option is
not selected, they will be sent.

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13 LIS
 Ignore Alarms for Unknown Chemistries: When the
checkbox is selected, the system will not give an alarm if
the samples downloaded from the LIS host contain
unknown chemistries without identification code. If this
option is not selected, an alarm will be given indicating
sample programming failure.
4 Select Save to save your input information.

5 Select Connect to connect the analyzer with the LIS host.
13.2.4 Defining Chemistry Code

3 View the chemistry channel number list on the right of the window.
The screen shows the chemistries and code in two columns. The left column provides
all chemistries that have been defined and set up correctly; the right column shows
the code for identifying a chemistry on the LIS host.
4 Click on the Channel No. column of a chemistry, and then type in a code for it.
5 Repeat step 4 to define a code for other chemistries.
6 Select Save.

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13 LIS
13.3 Programming Samples with LIS Host

13.3.1 Introduction
Sample programming information can be sent by or downloaded from the LIS host, and
then the measured results are sent to it manually or in real-time mode.
13.3.2 Programming Functions

Samples can be downloaded manually or automatically from the LIS host. If the system
status is Standby, you are allowed to download samples manually from LIS.
Sample programs downloaded from the LIS host can be edited. When programs are
downloaded for samples that are in Programmed status, the requested chemistries in the
programs will be used to overwrite the original chemistries; if the samples are in a status
other than Programmed, the requested chemistries will be added to the original ones.
Sending sample programs from LIS

1 When samples are sent from the LIS host to the analyzer, select Program-Sample.
2 Select List F5 to view downloaded samples.
3 On the Sample screen, type in the sample bar code, and then confirm the program
information.
4 Select Save F8.
5 Load the samples to idle positions of rack.
Obtaining samples automatically

When the system status is Standby or Sample Load, load the samples to rack, and then
select . The system will automatically scan the samples and then query the LIS host
to download relevant program information. After matching the downloaded program
information with the samples, the system will start the analysis.
The obtained sample program information includes:
 Patient demographics: patient name and gender.
 Requested chemistries: sample bar code, sample ID, sample type, chemistry code.
Downloading samples manually

2 Select List F5.
3 Select Download F3.
4 Choose one of the following options:
 All programmed samples: to download all samples programmed on the current
day.
 Latest samples: to download samples that are programmed on the current day
but have not been downloaded.
 Samples with the following IDs: to download samples with the specified program
date and ID. Enter the sample IDs or ID range to download.

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13 LIS
 Sample with the following bar code: to download the sample with the specified
bar code. Enter the bar code of the desired sample.
5 Select OK.
6 Confirm the sample information and selected chemistries/panels.
7 Load the samples to idle positions of rack.
8 Select the icon on the upper-right corner of the main screen,.

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13 LIS
13.4 Result Transmission
13.4 Result Transmission

13.4.1 Introduction
Sample results and QC results can be sent manually or in real-time mode to the LIS host
for reviewing and storage. When a sample is analyzed with its all tests finished, the
system can automatically send the test results to the LIS host; also you are allowed to
search for desired results and then manually send them to LIS.
Patient demographics, sample results and QC results can be sent to the LIS host.
13.4.2 Result Transmission Setup

When all tests of a sample are finished and at least one of them has calculated a result, the
result can be sent to the LIS host automatically. The results of all replicates of a sample or
chemistry will sent to the LIS host.
3 Mark the Send Complete Samples or Send Incomplete Samples checkbox with a
tick.
A sample will be sent to the LIS host automatically when it changes from In Progress
to Complete or Incomplete. If you won’t send results, deselect the checkbox.
4 Select Save.
13.4.3 Manually Sending Results to LIS Host

2 Search for control results or sample results to transmit.
3 Select desired samples in the sample list.
4 Select Host F8.
5 Select the sample range you want to transmit:
 Selected sample(s)
 All samples
6 If you transmit all results, you are allowed to skip those that are already transmitted
to the LIS host. Mark the Bypass Transmitted Results checkbox.
7 Select OK.

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13 LIS
13.5 Troubleshooting LIS
13.5 Troubleshooting LIS

For troubleshooting methods of the LIS host, refer to 16 Alarms and Troubleshooting
(page16-1).

Operator's Manual
14 Diagnostics
This chapter provides test descriptions, test procedures, test results and corrective
actions for diagnosis in photometer, level sense test, dispersion, substrate dispensing,
system and wash buffer dispensing system.

Operator's Manual
14 Diagnostics
14.1 Overview
14.1 Overview
Diagnostics consists of a series of tests and actions, which are used for troubleshooting
errors. These tests and actions are made to detect failures, but cannot be used to confirm
one specific failure. Users should make a judgment by integrating the information of
diagnosis and warnings with the failure characteristics. Diagnostic tests available in the
following modules are described in the table below.
Table 14.1 Categories of diagnostics
Function Module Description
Photometer Photometer diagnostic tests are used to check whether the
performance of the photometer is normal.
Level detection Level detection tests are used to check the level detection
function of the probe and helps to detect the reasons for
the related level detecting failure.
Dispersion Dispersion diagnosis are used to check dispensing volume
and aspirating residue.
Substrate dispensing Substrate dispensing diagnosis are used to check the
substrate dispensing volume.
Wash buffer Wash buffer dispensing diagnosis is used to check if the
dispensing wash buffer bubble optical coupler is normal.
System System diagnosis is used to check the system performance
and check the background, wash buffer and probe
performance, cleaning and wash.

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14 Diagnostics
14.2 Photometer diagnosis

14.2.1 Introduction
When photometer error occurs or the components of the photometer are replaced,
performing photometer diagnosis can check if the key performance of the photometer is
normal. Diagnosis includes dark current count diagnosis, photometric count diagnosis
and DCF diagnosis. Situations of each diagnosis are as follows:
 Photometer or components are replaced: perform dark current count diagnosis,
photometric count diagnosis and DCF diagnosis.
 QC out of range: perform photometric count diagnosis and DCF diagnosis.
 Abnormal clinical precision: perform photometric count diagnosis and DCF
diagnosis.
14.2.2 Dark Current Count Diagnosis

Dark Current Count Diagnosis is to check the dark current count of each cuvette position
and evaluate the dark current count and SD of all dark current count positions.
Test procedure
1 Select Utility-Maintenance-Diagnostics,.
2 Select Photometer Diagnosis.
Dark Current Count Diagnosis screen is displayed by default.

Figure 14.1 "Dark Current Count Diagnosis" screen
3 Input the desired start cuvette and stop cuvette.

4 Select Start.

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14 Diagnostics
The system will perform dark current count by position order. The tested data will be
displayed in the table of the screen. To stop testing, click Stop.
The position which is marked red indicates abnormal dark current count.
Result judgment and corrective actions

If the test result is abnormal, please contact our customer service department or your
local distributor.
14.2.3 Photon Count Diagnosis

Photon count diagnosis evaluates the mean and coefficients of variation (CV) of
Photometric count by reference of LED light intensity.
Test procedure
1 Select Utility - Maintenance - Diagnostics.
3 Select Photon Count Diagnosis.
Figure 14.2 Photon count diagnosis screen
3 Input the DA of LED.
It is 58000 by default.
4 Input test cycle.
5 Select Start.
The system will start photon count testing. The test data is displayed in the table of
the screen. To stop testing, click Stop.

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14 Diagnostics
If the test result is Fail, please contact our customer service department or your local
distributor.
14.2.4 DCF Diagnosis

DCF Diagnosis is used to calculate calibrator factor DCF.
1 Select Utility - Maintenance - Diagnostics
3 Select DCF Diagnosis.
Figure 14.3 "DCF Diagnosis" screen
3 Input test cycles.
4 Select Start.
The system will start DCF testing. The test data is displayed in the table of the screen.
To stop testing, click Stop.

If the test result is Fail, please contact our customer service department or your local
distributor.

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14 Diagnostics
14.3 Level Sense Diagnosis

14.3.1 Introduction
The Level Sense Test is used to diagnose the level detection performance of the probe and
gives related data that helps you locate the causes of an error.
Perform this test in the following conditions:
 An alarm is given out indicating that the probe contacts no liquid at the aspirate
position, and the analysis is stopped.
 An alarm is given out indicating that the probe aspirates nothing in the aspiration
position and the analysis is stopped, and it is confirmed that the failure is not caused
by probe clog.
 An alarm is given out indicating that the probe aspirates nothing in any aspiration
position and the analysis is stopped.
14.3.2 Level Sense Diagnosis

Test procedure
2 Select Level Sense Diagnosis.
3 Set the Lane number.
4 Place 2/3 tube water in the No.1 position of the sample rack and then place the
sample rack to the set lane; select Next to display the Level Sense Diagnosis screen.
Figure 14.4 "Level sense diagnosis" screen
5 Click Start.
The system will run level sense diagnosis at the aspirate position 20 times
consecutively.
6 When tests are completed, the level sense test data are displayed on the screen.

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14 Diagnostics

If the operating voltage of the level detection board is beyond the reference range of
2.8V-4.8V, contact our customer service department or your local distributor.
If the result of the level detection performance is abnormal, contact our customer service

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14 Diagnostics
14.4 Dispersion Diagnosis

14.4.1 Introduction
Dispersion Diagnosis is used to check the dispensing volume and aspirating volume of
the peristaltic pump.
14.4.2 Dispersion Dispense Volume Diagnosis

Test procedure
2 Select Dispersion Diagnosis.
3 Select Dispersion Dispense Volume Diagnosis.
Figure 14.5 Dispersion dispense volume screen
4 Select Start.
To stop testing, click stop.

Cause: Liquid leakage occurs in dispersion syringe, tubing or connectors; dispersion
dispensing probes are clogged or solenoid valve failed; probe level sense failed or the
sampling parameters are incorrect.
Corrective actions: If the test result is abnormal, please contact our customer service
14.4.3 Dispersion Aspirating Volume Diagnosis

When dispersion aspirating is abnormal, perform aspirating residue diagnosis.

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14 Diagnostics
Test procedure
2 Select Dispersion Diagnosis.
3 Select Dispersion Aspirating Volume Diagnosis.
Figure 14.6 "Dispersion Aspirating Volume Diagnosis" screen
4 Select Start.

Cause: The dispersion aspirating probes are clogged; the pump tubing is aged or has
leakage; the dispersion dispensing volume is insufficient or dispersion dispensing failed.
Corrective actions: If the dispersion aspirating probes are clogged, please change them; if
the abnormal test results are caused by other factors, please contact our customer service

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14 Diagnostics
14.5 Substrate Dispensing Diagnosis

14.5.1 Introduction
Perform substrate dispensing volume diagnosis in the following situation:
 The test results have large deviation
 Test substrate dispensing precision
Perform substrate dispensing bubble diagnosis in the following situation:
 Check if the dispensing or aspirating optical coupler works normally.
 Check if leak occurs to substrate tubing.
14.5.2 Substrate Dispensing Bubble Diagnosis

Test procedure
1 Select Utility - Maintenance - Diagnosis.
2 Select Substrate Dispensing Bubble Diagnosis.
Figure 14.7 Substrate dispensing bubble diagnosis
3 Input number of cuvette tested; the default is 3.

4 Select Start.

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14 Diagnostics
Cause: Substrate dispensing optical coupler goes wrong; although substrate dispensing
optical coupler and aspirating optical coupler work normally, leak occurs to the substrate
tubing; substrate aspirating optical coupler goes wrong and air bubbles are aspirated into
the tube.
Corrective actions: Contact our customer service department or your local distributor to
change substrate dispensing optical coupler or aspirating optical coupler or substrate
tubing.
14.5.3 Substrate Dispensing Volume Diagnosis

Test procedure
1 Select Utility - Maintenance - Diagnosis.
2 Select Substrate Dispensing Diagnosis.
3 Select Substrate Dispensing Volume Diagnosis.
Figure 14.8 Substrate dispensing volume diagnosis screen
4 Select Start.

Cause: the substrate tubing is empty or has leakage or the substrate spike is clogged or
the solenoid valve failed; probe level sense failed or the sampling parameters are
incorrect.

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14 Diagnostics
Corrective actions: if the substrate tubing is empty, please replace the substrate bottle
with new one; if substrate tubing has leakage or the substrate spike is clogged, please
change the substrate dispensing tubing; if the abnormal test results are caused by other
factors, please contact our customer service department or your local distributor.

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14 Diagnostics
14.6 Wash Buffer Dispensing Diagnosis

14.6.1 Introduction
Wash buffer dispensing diagnosis is used to check if the wash buffer air bubble optical
coupler is normal.
14.6.2 Wash Buffer Dispensing Bubble Diagnosis(Inlet tube not empty)

Test procedure
2 Select Wash Buffer Dispensing Diagnosis.
3 Select Wash Buffer Dispensing Bubble Diagnosis(Inlet tube not empty).
Figure 14.9 Wash buffer dispensing bubble diagnosis(Inlet tube not empty)
4 Select Start

Cause: the wash buffer bubble optical coupler is not calibrated or needs recalibrating or
goes wrong.
Corrective actions: Perform Sensor Calibration- Auto adjustment of wash buffer bubble
optical coupler maintenance procedure. If the optical coupler failed, please contact our

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14 Diagnostics
14.6.3 Wash Buffer Dispensing Bubble Diagnosis(Inlet tube empty)

Test procedure
2 Select Wash Buffer Dispensing Diagnosis.
3 Select Wash Buffer Dispensing Bubble Diagnosis(Inlet tube empty).
4 Take out the wash buffer inlet device from the tank,
Figure 14.10 Wash buffer dispensing bubble diagnosis(Inlet tube empty)
5 Select Start

Cause: the wash buffer bubble optical coupler is not calibrated or needs recalibrating or
goes wrong.
Corrective actions: Perform Sensor Calibration- Auto adjustment of wash buffer bubble
optical coupler maintenance procedure. If the optical coupler failed, please contact our

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14 Diagnostics
14.7 System Diagnosis

14.7.1 Introduction
System Diagnosis is used to check the background, wash buffer, washing and cleaning
effect and probe sampling performance. All these diagnosis items can be executed
together, independently or by group.
14.7.2 System Check

System check is used for daily maintenance, system diagnosis and performance test.
Test procedure
1 Select Utility - Maintenance - Diagnostics
2 Select System Diagnosis.
3 Select System Check.
4 Set the lane number; the default is 1.
Figure 14.11 System check screen
5 Put a rack into the assigned lane and dispense at least 1 ml system check solution 1
in 1# position on the rack (used for the precision test of the probe) ; dispense 2ml
system check solution 2 in 2# position on the rack (used for cleaning test).
6 Select the desired test item.
NOTE
Wash Buffer Test shall be executed together with background test; Wash test shall
be executed with background test, probe test and cleaning test; Cleaning Test shall
be executed with background test, wash test and probe test.
7 Select Start.

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14 Diagnostics
8 After the diagnosis, select Exit to exit the window.

Troubleshoot errors with the following methods:
 If background test failed, the substrate may be contaminated or substrate dispensing
or photometer failed.
 If wash buffer test failed, the substrate or the wash buffer is possibly contaminated
or substrate dispensing or photometer failed.
 If probe test failed, the substrate or the wash buffer is possibly contaminated or
substrate dispensing or photometer failed or reagent probe sampling system goes
wrong.
 If wash test failed, the substrate is possibly contaminated or substrate dispensing,
dispersion aspirating or dispensing failed.
 If cleaning test failed, the substrate is possibly contaminated or substrate dispensing,
dispersion aspirating or dispensing failed.

Operator's Manual
15 Maintenance
This chapter provides you with maintenance of the instrument, including frequently-used
maintenance commands and scheduled maintenance procedures. The purpose, time,
system status, precautions and steps of each maintenance procedure are described here.

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15 Maintenance
15.1 Overview
15.1 Overview
15.1.1 Introduction
Maintenance of the system should be performed regularly by trained personnel to ensure
reliable performance and reduce unnecessary service calls. Even you are only an operator,
it is important for you to read this chapter. Your thorough understanding will help you
obtain the best performance of the system.
The system provides maintenance commands and scheduled maintenance procedures.
The Scheduled Maintenance Log feature allows you to understand what maintenance is
needed, when it is performed and who performed the procedure. It is capable of
reminding you of the maintenance that is due and keeping track of what is happened
during a maintenance procedure.
In the case of maintenance that is beyond your capability or not covered in this chapter,
The maintenance frequencies stated in this manual are based on working for 5 hours a
day, that is 5*120=600 tests/day, and 5*120*25=15,000 tests/month.
WARNING
Do not perform any maintenance procedures that are not described in this chapter;
otherwise, equipment damage or personal injury may be caused.
Do not touch the components other than those specified in this chapter.
Performing unauthorized maintenance procedures can damage the instrument and cause
personal injury, or invalidate the applicable warranty provisions in the service contract.
After performing maintenance, make a verification to ensure that the system runs
normally.
Do not spill water or reagent on mechanical or electrical components of the system.
If the system is to be stored for a long time (over 1 week) or transported, contact our
customer service department or your local distributor to perform necessary maintenance
in order to ensure the system’s optimal performance in following use.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
15.1.2 Maintenance Consumables

Please use the maintenance consumables manufactured or recommended by our
company in order to achieve the promised system performance. If needed, contact our

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15 Maintenance
15.1 Overview
Table 15.1 Component information
Item Position Remark
Probe Probe arm As-needed/as-required
part. Replace it when it is
obviously damaged or bent.
Pump tube Dispersion carousel Regularly-replaced part.
Replace it when: it serves
for 6 months; or it is
obviously damaged.
Syringe Dispensing assembly Regularly-replaced part.
Replace it when: it serves
for 3 months; or it is
obviously damaged.
Dispersion Aspirate Probe Dispersion Aspirate Station Regularly-replaced part.
Assembly Replace it every week; or it
is obviously damaged.
Substrate spike Substrate System As-needed/as-required
part. Replace it when it is
obviously damaged.
Cuvette Reaction carousel Disposable consumables.
Control Sample rack Used in QC test
Calibrator Sample rack Used in Calibration test
Substrate Substrate system Replace it when exhausted.
Wash buffer Fluidic system Replace it when exhausted.
Reagent Reagent carousel Replace it when exhausted.
15.1.3 Tools Required for Maintenance

The following tools will be used for maintenance of the system.
Accompanying tools
Table 15.2 Accompanying Tools
Item Applicable Maintenance
Philips-head screwdriver φ3.3×100 Removing the system enclosure and the
cooling fans
Philips-head screwdriver φ4.7×100 Installing the probes
Slot-head screwdriver φ4.7×100 Installing/removing the probes, and installing
the tube hoop.
Wash solution CD80 Special Wash
Cleaning tool for dispersion Cleaning dispersion aspirate probes
probes(Unclogging device and syringe)
Unclogging device for probe Unclogging the probe
Substrate wash solution Washing the substrate tubing system
Tools prepared by user

Table 15.3 Tools Prepared by User

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15 Maintenance
15.1 Overview
Item Applicable Maintenance

Clean gauze or tissue Check the syringe and wipe the rotor, exterior
of the probe and dispersion dispense probe
Cotton swabs Clean aspirate position, diluting position
hole, vortexer hole, reaction carousel hole,
dispersion carousel hole, wash well and so on.
Suction cleaner Cleaning the fans and dust screens
Hair brush Clean Dust Screen
Tweezers Removing/Installing syringe washers
Thread syringe Unclogging the probe
Beaker Cleaning the needle and unclogging device
Ethanol Clean probe, dispersion unit and so on
Fiber-free gloves Clean the exterior of the probe, dispersion
dispense probe,etc.
Screen and keyboard wash solution Cleaning the touchscreen and keyboard

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15 Maintenance
15.2 Maintenance Command

15.2.1 Introduction
The Maintenance feature provides maintenance instructions for the system, which
include maintenance of the sampling system, dispersion system, hydro system and other
system.
Sample Handling System Maintenance:
 Clean Probe Interior
 Clean Probe Exterior
 Syringe Maintenance
 Clean/Replace Probe
Dispersion System Maintenance:
 Clean Dispersion Probes/Tubes
Maintenance of Hydro System:
 Sensor Calibration
Other System Maintenance:
 Home
 Clean Vortexer
 Clean wash well
 Daily Clean
 Effect Check
 Discard Cuvettes
 Fluidic Prime
 Clean the cap of the wash buffer tank
If the system is stopped due to hydraulic problems, Home is disabled. Prior to executing
the command, select the icon of the analyzer to enter the system overview screen and
execute Home procedure to recover the failure, or troubleshoot the hydraulic problems.
The maintenance is described in detail in the following sections.
15.2.2 Maintenance Screen Overview

1 Select Utility – Maintenance.
2 Select Maintenance Command to display Maintenance Command screen.

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15 Maintenance
Figure 15.1 "Maintenance Command" screen
Maintenance instructions
Provides frequently-used maintenance procedures of the system. Select a maintenance
instruction button to start the maintenance.
Online help
Online help information is provided for each maintenance command. Select the icon
to the left of a maintenance command to show relevant instructions.
Exit
Select this button to close the Maintenance window

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15 Maintenance
15.3 Remote Help
15.3 Remote Help

15.3.1 Introduction
Through the Remote Help function, you can send requests of error troubleshooting and
instrument maintenance to the service personnel. Before using this function, ensure that
the service personnel has installed the remote help client on the instrument.
15.3.2 Remote Diagnosis and Maintenance

1 Tell service personnel your requests for error troubleshooting and instrument
maintenance, and consent to remote help.
2 Select Utility- Maintenance- Remote Help to send remote help requests to the
service personnel through the software while following their instructions.
When receiving your requests, the service personnel will start remote-control on
your instrument to do troubleshooting or maintenance according to your
requirement. You should not run tests or perform other operations during remote
control.

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15 Maintenance
15.4 Cloud Web
15.4 Cloud Web

15.4.1 Introduction
Cloud Web command will enable you to connect to Mindray Website to download the
parameters and related information of the analyzer. The function is not open to overseas
users yet.
15.4.2 Cloud Web

1 Select Utility- Maintenance.
2 Select Cloud Web.

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15 Maintenance
15.5 Scheduled Maintenance

15.5.1 Introduction
Scheduled maintenance procedures are determined by use of the components and
frequency of performance, and should be performed regularly by trained personnel to
ensure reliable performance and reduce unnecessary service calls. Read this section
carefully prior to doing the maintenance.
The Customize feature allows definition of maintenance procedures and configuration of
manufacturer-/user-defined maintenance procedures for each maintenance frequency.
The Electronic Maintenance Log is provided enabling you to record comments and other
important information of maintenance.
Most of the scheduled maintenance procedures are performed by executing maintenance
instructions, while the remaining part by manual operations. Perform the maintenance
strictly as instructed in this manual.
15.5.2 Maintenance Schedule

The scheduled maintenance procedures are divided into the following periods:
 Daily: 1 day
 Weekly: 8 days
 Two-week: 15 days
 Monthly: 31 days
 Three-month: 91 days
 Six-month: 181 days
 Other (As-needed/As-required)
The maintenance frequency is counted down from the date of performing. When the
countdown becomes 0, the corresponding maintenance procedure is highlighted in
yellow. To determine that a due maintenance procedure is due, check if the following
items are displayed in yellow background:
 Utility button on the main screen
 Maintenance tab
 Maintenance button
 Scheduled Maintenance tab
 Maintenance frequency tab
 Maintenance procedure
The maintenance information will not be lost when the operating software version is
upgraded. When new version software is installed to remove the system failure or fix the
system, the maintenance counter returns to 0 and restarts a countdown.
15.5.3 Scheduled Maintenance Procedures

Maintenance procedures vary from different maintenance frequencies. The maintenance
procedures described in this chapter are based on a complete configuration of the system.
If some modules are not equipped on your system, you have no need to perform relevant
maintenance.

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15 Maintenance
Daily maintenance:
 Check waste tank connection
 Check consumable status
 Check syringe
 Check probe
 Clean probes exterior
 Clean exterior of dispersion aspirate probes
 Daily clean
 Effect check
Weekly maintenance:
 Replace/Clean aspirate probes
Monthly maintenance:
 Clean dust screen
 Clean wash well
 Wipe dispense probes/tubes
 Clean vortexer hole
Three-month maintenance:
 Wash buffer air bubble coupler calibration
Other (As-needed/As-required):
 Clean analyzer panels
 Clean reagent carousel
 Probe interior
 Replace syringe
 Replace probe
 Remove air bubbles in syringe
 Bar code maintenance
 Discard cuvettes
 Fluidic prime
 Clean the cap of the wash buffer tank
Perform the scheduled maintenance according to the instruction in this chapter. Run a
calibration or quality control after performing the maintenance.
15.5.4 Maintenance Log List

Refer to the following table for scheduled maintenance procedures you are supposed to
perform. Please copy it every month and place a check mark in relevant day column every
time after you perform maintenance.

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15 Maintenance
Table 15.4 Maintenance Log List
Maintenance Log Sheet
Year Month
Daily Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Check Waste Tank Connection
2 Check Consumable Status
3 Check Syringes
4 Check Probe
5 Clean probe exterior
Clean exterior of dispersion
6
aspirate probes
7 Daily Clean
8 Effect Check
Weekly Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Replace/Clean Aspirate Probes
Monthly Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Clean Dust Screen
2 Wipe Dispense Probes/tubes
3 Clean wash well
4 Clean Vortexer Hole
Three-Month Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Wash buffer bubble optical
1
coupler Calibration
As-Required/As-Needed Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Clean Analyzer Panels
2 Clean Reagent Carousel
3 Clean probe
4 Replace probe
5 Remove Air Bubbles in Syringe
6 Bar Code Maintenance
7 Discard Cuvettes
8 Fluidic Prime
9 Replace syringe
10 Clean the Cap of Wash Buffer Tank

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15 Maintenance

Operator's Manual Version: 2.0
15 Maintenance
15.5.5 Scheduled Maintenance Screen Overview

The Scheduled Maintenance screen contains maintenance frequency tabs, maintenance
procedures, scroll bar, and function buttons. Select a tab to view the maintenance
procedures to be performed in the period. Choose a maintenance procedure, and then
select function buttons to access windows to execute an operation.
Figure 15.2 Scheduled Maintenance screen
Fields and buttons on the screen are introduced as follows.

Maintenance procedures
Shows the preset and user-defined maintenance procedure for the current maintenance
frequency.
Select field
Choose a maintenance procedure and click on the corresponding Select checkbox. A tick
appears in the middle of the checkbox, which indicates the maintenance procedure is
chosen. Select the function buttons at the bottom of the screen to access a window or
execute an operation. To deselect a maintenance procedure, click on the Select checkbox
again. The tick inside the checkbox disappears, which indicates the maintenance
procedure is deselected.
Property field
Shows how the maintenance procedure is defined. The Property includes two options:
System and User. System indicates that the maintenance procedure is defined by the
manufacturer and cannot be configured; user indicates that the maintenance is defined
by user and can be configured for each maintenance frequency.
Operator field
Shows who performs the maintenance procedure, that is, the user ID currently logging on
the system.

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15 Maintenance
Date Performed field
Shows the date confirmed by the operator on which the maintenance was performed.
After performing a maintenance procedure, mark the Select checkbox and select OK. The
date is refreshed and displayed as the current date. The system will restart the
countdown of the maintenance frequency from the current date.
Scroll bar
If all maintenance procedures of a period are not shown on the current screen, move the
scroll bar view more maintenance procedures.
Select All button
This function allows selection of all maintenance procedures currently available on the
screen. When the Select All button is selected, a tick appears in all Select checkboxes to
the right of the maintenance procedures. Choose the following buttons as needed:
 OK: allows the reviewal of the selected maintenance procedure and entering of the
date performed.
 Log: allows recording of comments and other important information of maintenance.
 History: provides a history record of maintenance performance with date and
operator for the procedure selected.
OK button
This function allows the reviewal of the selected maintenance procedure and entering of
the date performed. When the approving a maintenance procedure, the date of
performance will be displayed as the current date.
Log button
The electronic maintenance log function allows the recording of comments and other
important information of maintenance. Choose one or more maintenance procedures,
and then select the Log button. The Maintenance Log window shows. Input logs for the
procedure selected, and then select OK. Your input information will be applied to the
selected maintenance procedure.
History button
This feature provides a history record of maintenance performance with date and
operator for the procedure selected. You are allowed to edit or delete a maintenance
record. Please note that only one maintenance procedure can be recalled for history
performance at one time.
1 Choose a maintenance procedure on the Scheduled Maintenance screen.
2 Select History. The Maintenance Log window is displayed.
3 View all performance records of the selected maintenance procedure.
4 To edit a maintenance record:
 Mark the checkbox of the desired maintenance record.
 Select Edit.
 Modify the maintenance record.
 Select OK.
Only one maintenance record can be edited at one time.
5 To delete maintenance records:
 Mark the checkbox of one or more desired maintenance records.
 Select Delete.

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15 Maintenance
 Select OK. The selected maintenance records are removed.
Customize button
The Customize function allows definition of new maintenance procedures and
configuration of manufactured-/user-defined maintenance procedures. User-defined
maintenance procedures can be deleted.
Select Customize on the Scheduled Maintenance screen. The Customize
Maintenance Procedure window is displayed.
To define a maintenance procedure:
 Select New.
 Enter the name of the new maintenance procedure.
 Select OK. The maintenance procedure is displayed in the Available Procedures list.
 Use >> and << to configure or cancel user-defined maintenance procedures. The
property of a user-defined maintenance procedure is User.
 Select OK to save the configuration, or select Cancel to abort it.
To configure a maintenance procedure:
 Choose a maintenance frequency in the Frequency pull-down list.
 Choose a maintenance procedure in the Available Procedures list. Move the
vertical scroll bar to view more maintenance procedures.
 Select >>. The selected maintenance procedure appears in the Enabled Procedures
list, and the relevant maintenance schedule screen will be refreshed automatically.
To remove a maintenance procedure:
 Choose a maintenance procedure in the Enabled Procedures list.
 Select <<. The selected maintenance procedure is removed from the Enabled
Procedures list and appears in the Available Procedures list. The relevant
maintenance schedule screen will be refreshed automatically.
 Select OK to save the configuration, or select Cancel to abort it.
Delete button
The system allows deleting of maintenance procedures that will no longer be used. Only
user-defined rather than manufacturer-defined maintenance procedures can be deleted.
1 Choose a maintenance procedure on the Scheduled Maintenance screen.
2 Select Delete.
3 Select OK. The selected maintenance procedure is deleted. The Available
Procedures list on the Customize Maintenance Procedure window is refreshed
automatically.
Close
Select this button to close the Maintenance window

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15 Maintenance

15.6.1 Check Waste Tube/Tank Connection
If the waste tube is not connected properly, overflow may be caused, resulting in
environmental contamination or carryover, or even damaging the equipment.
Purpose
To check the waste tube connection and the waste tank to prevent overflow.
When to do
You are recommended to do this maintenance procedure every day before starting the
analysis.
System status
Make sure that the system status is Incubation or Standby.
Precautions:
BIOHAZARD
Dispose of the waste in accordance with your local or national guidelines for biohazard
waste disposal.
How to do
1 Check that the waste tube is clear and not bent or folded. If it is, the waste may run
over the analyzer’s panel, or even damage the analyzer.
2 If leak remains after performing the above-stated steps, contact our customer
service department or your local distributor.
3 If waste tank is used to hold the liquid waste, check the waste tank and empty it.
4 Select Utility - Maintenance - Maintenance and then select Scheduled
Maintenance – Daily.
5 Mark the Select checkbox to the right of Check Waste Tank Connection.
6 Select OK to refresh the current date as the performance date.
7 Select Log and then record comments and other important information for the
procedure.
15.6.2 Check Consumable Status

Consumables include sample diluent, substrate, cuvette, container, probe wash solution
and wash buffer. Insufficient consumables will affect or stop test. Prior to test every day,
check the volume, and fill more, if necessary.
Purpose
To check the consumable volume to prevent measurements from being terminated.
When to do
analysis.

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15 Maintenance
System status
You are allowed to do this maintenance procedure in any system status.
Precautions:
BIOHAZARD
How to do
1 Select Reagent – Consumable Management, or select Reagent - Reagent
Overview.
2 Check the inventory status of the sample diluent, substrate, cuvette, waste container,
probe wash solution and wash buffer.
3 If some of the consumables are insufficient, add or handle them referring to 2.5
Preparing Reagents ( page 2-16).
5 Mark the Select checkbox to the right of Check Consumable Status.
procedure.
15.6.3 Check Syringe

The syringe is precise device used to aspirate/dispense small amount of sample and
reagent. If the syringe leaks, it cannot aspirate/dispense the correct amount of sample or
reagent, and may even be damaged. Prior to measurements every day, check the syringe
for leak.
Purpose
To check the syringe for leak and air bubbles.
When to do
analysis.
Materials required
Clean gauze or tissue
System status
Precautions:
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1 Open the upper protective shield, loosen the screw on the cover of the syringe in the
right rear of the analyzer and remove the cover.

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15 Maintenance
2 Check T piece for leakage.
3 Use dry gauze to wipe the T piece, and then check if the gauze is moistened.
 If it is, tighten the T piece.
 Check the T piece again. If the leak remains, check if the washer inside the
syringe connector is intact.
 If the washer is damaged, replace it with a new one; otherwise, replace the
syringe. For details, please refer to 15.9.3 Replace Syringe(Page15-34)
4 Check the syringe interior for air bubbles. If yes, take actions according to 15.9.6
Remove Air Bubbles in Syringe ( page 15-40)
5 Check the plunger guide cap at the bottom of the syringe for leak.
6 Use dry gauze to wipe the plunger guide cap, and then check if the gauze is
moistened.
 If it is, tighten the plunger guide cap.
 Check the plunger guide cap again. If the leak remains, replace the syringe
according to 15.9.3 Replace Syringe (Page15-34).
7 Check if the retaining screws at the bottom of the syringe are tightened.
 If not, tighten them and proceed to the next step.
 If yes, proceed to the next step.
8 Close the front door of the analyzer.
10 Mark the Select checkbox to the right of Check Syringe.
procedure.
14 Restore the upper protective shield.
15.6.4 Check Probe

Abnormal probe may influence the measurement performance and result in inaccurate
results. Prior to measurements every day, check the probe for stains and crystals, and
check if the wash well is clogged. If the above-mentioned abnormities exist, clean or
adjust the probe immediately.
Purpose
To check the probe for water dripping, stains and liquid flow abnormities, and check if
liquid flows out normally from the wash well.
When to do
analysis.
System status
Precautions

Operator's Manual
15 Maintenance
WARNING
The probe is sharp and vulnerable. To prevent injury and equipment damage, exercise
caution when working around the probe. Keep away from the probe to avoid collision
with them.
BIOHAZARD
How to do
1 Make sure that the system status is Incubation or Standby; Open the upper
protective shield.
2 Check if the exterior of the probe is dirty. If it is dirty, please perform Clean probe
exterior procedure.
3 Select Utility - Maintenance - Maintenance and then select Maintenance
Command. Select Clean Probe Interior.
Figure 15.3 Clean probe interior
4 Select Continue.
5 Check the liquid flow of the probe. If the liquid flow is sprayed out or does not come
out vertically, the probe may be clogged. Perform the Daily Clean procedure, and
then check it again. If the abnormity remains, perform the Clean Probe Interior
procedure. If the abnormity still remains, perform the Clean/Replace Probe
procedure, or contact our customer service department.

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15 Maintenance
Figure 15.4 Normal and abnormal liquid flows of probe
OK Error
6 Select Continue.
7 Select Done.
8 Restore the protective shield.
Maintenance - Daily ;
10 Mark the Select checkbox to the right of Check Probe.
procedure.
15.6.5 Clean Probe Exterior

The probe is often dirty on its surfaces, causing carryover between samples or reagents
and resulting in inaccurate results. You are recommended to perform this procedure
every day.
Purpose
To clean the exterior of the probe to prevent carryover.
When to do
This procedure should be performed on daily basis.
Materials required
Alcohol-cotton, dust-free cotton swab or clean gauze, ethanol, deionized water
System status
Precautions:

Operator's Manual
15 Maintenance
WARNING
caution when working around the probe. If the probe is bent or damaged, it immediately;
otherwise, results may be obtained.
BIOHAZARD
How to do
1 SelectUtility-Maintenance-Maintenance and then select Maintenance Command.
2 Choose Clean Probe Exterior. The maintenance guide window pops up. Select
Continue.
Figure 15.5 Clean probe exterior
3 Open the upper protective shield

4 Rotate the probe arm to move the probe to a position convenient for cleaning, and
then use gauze soaked with ethanol or alcohol-cotton to gently wipe the probe
exterior. Clean the probe tip until it becomes clear without stain.
5 Use gauze moistened with deionized water to clear the ethanol on the probe.
Do not pull the probe horizontally to prevent probe damage.
6 Select Continue.
7 Select Done. The system resets the probe automatically.
8 Restore the upper protective shield.
9 Select Utility-Maintenance-Maintenance and then select Scheduled
10 Mark the Select checkbox to the right of Clean Probe Exterior.

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15 Maintenance
procedure.
15.6.6 Daily Clean

Daily clean function is used to clean the probe, and dispersion aspirate probes to keep
good performance of them, avoid probe clogging and reduce influence of the probe
carryover on the test result. 3.1ml concentrated wash solution is consumed during Daily
Clean process.
Purpose
Clean the probe and dispersion aspirate probes.
When to do
analysis.
Materials required
Concentrated wash solution
System status
Precautions:
BIOHAZARD
How to do
1 Select Utility - Maintenance – Maintenance and then select Maintenance
Command.
2 Select Daily Clean.
3 Add sufficient concentrated wash solution into the 62ml reagent bottle, and place it
in the special wash position.

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15 Maintenance
Figure 15.6 Daily clean
4 Select Execute.
5 After the daily clean is finished successfully, select Exit to exit the window.
7 Mark the Select checkbox to the right of Daily Clean ;
procedure.
15.6.7 Effect Check

Effect check is used to avoid crystallization in probe washing tubes, dispersion
dispensing tubes and substrate dispensing tubes and monitor the liquid contamination
and the working status of the photometric system. If you do not enable Effect Check on
the Auto Maintenance setup window, incorrect test results may be produced.
Purpose
To avoid crystallization in probe washing tubes, dispersion and substrate dispensing
tubes and monitor the liquid contamination and the working status of the and
photometric system.
When to do
Perform this maintenance in the status of standby.
System status
How to do
Command.

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15 Maintenance
2 Select Effect Check.
3 Set the interval of effect check For details, refer to 11.5.2 Auto Maintenance
Setup(Page 11-9).
The default is 4 hours. In standby status, effect check is performed every 4 hours.
4 Select Execute.
To stop the procedure, click Stop.
After the procedure, the photon count of each cuvette position will be displayed on
the screen.
6 Select Utility-Maintenance- Maintenance and then select Scheduled
7 Mark the Select checkbox to the right of Effect Check.
procedure.

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15 Maintenance
15.7 Monthly Maintenance
15.7.1 Clean Dust Screens

Dust may accumulate on the dust screens when the instrument is used for a long time,
influencing the ventilation and heat elimination effects. It is necessary to clean the dust
screens regularly.
Purpose
To clean the dust screens to ensure good ventilation.
When to do
This procedure should be performed on monthly basis.
Materials required
Suction cleaner, hair brush and fresh water
System status
Make sure that the analyzer main power is off.
Precautions
NOTE
Use a suction cleaner to clean the dust screens while keeping them uninstalled, or use a
hair brush and fresh water to clean the dust screens after removing them from the
analyzer.
Do not reinstall the dust screens until they are dry completely.
Install the dust screens correctly to avoid gaps.
How to do
1 Switch off the analyzer’s main power.
2 Remove dust screen on the right of the analyzer.
Press the dust screen inwards on the two sides and pull upwards to remove dust
screen.

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15 Maintenance
Dust screen
3 Use the suction cleaner, or hair brush and fresh water to clean the dust screens, and
then dry them in air.
4 Reinstall the dust screens when they are dry.
5 Close the front door of the analyzer.
6 Power on the analyzer and run the operating software.
7 Make sure that the system status is Incubation or Standby.
8 Select Utility-Maintenance-Maintenance then select Scheduled
Maintenance-Monthly.
9 Mark the Select checkbox in the same row as Clean Dust Screens.
11 Select Log, and then record comments and other important information for the
procedure.
15.7.2 Clean Wash Wells

Dirty wash well may contaminate the probe and lead to erroneous test results. You are
recommended to perform this procedure every month.
Purpose
To clean the wash well of the probe in order to prevent carryover.
When to do
Materials required
Clean cloth swabs, ethanol, and deionized water
System status
Precautions

Operator's Manual
15 Maintenance
BIOHAZARD
How to do
1 Select Utility - Maintenance - Maintenance - Maintenance Command.
2 Choose Clean Probe Exterior. The maintenance guide window shows. Select
Continue.
Figure 15.7 Clean probe exterior
3 Open the upper protective shield.

4 Rotate the probe arm to move the probe to a position convenient for wash well
cleaning, and then use gauze soaked with ethanol to gently wipe the wash well till it
is clean.
5 Use cloth swabs dipped with deionized water to clear the ethanol left on the wash
well.
6 Select Continue.
7 Select Done. The system resets automatically.
8 Close the upper protective shield of the analyzer.
Maintenance –Monthly.
10 Mark the Select checkbox to the right of Clean Wash Well.
procedure.

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15 Maintenance
15.7.3 Wipe Dispense Probes/Tubes

If crystallization occurs to dispersion dispense probes, dispersion washing will be
insufficient and substrate dispensing volume will be inaccurate, which will affect the test
results. So it is required to check the dispersion dispensing probes regularly.
Purpose
Check the outer part of the bottom of dispensing probe especially near the hole after
removing the dispensing probe; wipe the crystals if there are any.
When to do
Materials required
Clean gauze
System status
Precautions
WARNING
caution while working around the aspirate probe. If it is bent or damaged, replace it
immediately; otherwise, unreliable results may be obtained.
BIOHAZARD
NOTE
Take caution and do not bent the dispersion dispensing probes and substrate dispense
tube.
How to do
Command.
2 Select Clean Dispersion Probes/Tubes command.

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15 Maintenance
Figure 15.8 Clean Dispersion Probes/Tubes
3 Open the protective shield of the analyzer.

4 Select Continue.
5 Unscrew the round nut on the aspirate/dispense plate counter-clockwise and lift it
upward, , pull the dispensing probe from the dispersion carousel.
Keep the soft tube connection tightly, do not loosen or drop the dispensing probe.
6 Wipe the exterior of the dispensing probe with gauze moistened with deionized
water.
7 Install the dispensing probe back to the aspirate/dispense plate and tighten the nut,
check if the connection of the soft tube is loose; if so, tighten the connection.
8 Repeat step 5-7 to clean other dispersion dispensing probes.
9 Select Continue.
10 Select Done.
11 Restore the shielding cover of the analyzer.
Maintenance – Monthly.
13 Mark the Select checkbox to the right of Wipe Dispense Probes/Tubes.
15 Select Log and then record commends and other important information for the
procedure.
15.7.4 Clean Vortexer Hole

Dust in the vortexer hole will affect the mixing effect. It is recommended to clean the
vortexer hole monthly.
Purpose
Clean the vortexer hole to ensure good mixing performance
When to do

Operator's Manual
15 Maintenance
Materials required
Clean cotton swabs and ethanol
System status
How to do
1 Open the protective shield of the analyzer and remove the cover above the gripper.
Command.
3 Select Clean Vortexer.
Figure 15.9 Clean vortexer
4 Select Continue.
5 Wipe the vortexer hole gently with ethanol cotton swab.
6 Install the cover above the gripper back and restore the protective shield of the
analyzer.
7 Select Continue.
8 Select Done.
Maintenance – Monthly.
10 Mark the Select checkbox to the right of Clean Vortexer Hole.
procedure.

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15 Maintenance
15.8 Three-Month Maintenance
15.8 Three-Month Maintenance

15.8.1 Wash buffer bubble optical coupler calibration
Purpose
To ensure the precision of the highly sophisticated part.
When to do
This procedure should be performed every three months.
System status
Make sure that the system status is stopped or incubation.
How to do
1 Select Utility - Maintenance - Maintenance then select Maintenance Command.
2 Select Sensor Calibration and then the screen Auto adjustment of wash buffer
bubble optical coupler pops up.
3 Make sure the current volume of the wash buffer is more than 1/3 tank; click
Continue.
Figure 15.10 Auto adjustment of wash buffer bubble optical coupler
4 Select Start.
5 Select Done.
Maintenance – Three –Month.
7 Mark the Select checkbox to the right of Wash Buffer Bubble Detection Coupler
Calibration.
procedure.
10 Select OK to save your input information

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15 Maintenance
15.9 As-Needed/As-Required Maintenance

15.9.1 Clean Analyzer Panels
The analyzer and computer are often accessed and easily get dirty. To keep a good
operating environment and minimize the biohazards, clean the components that are
often accessed, such as analyzer panel, carousel cover, touchscreen, keyboard, etc.
Purpose
To clean the analyzer panels, carousel covers, touchscreen and keyboard.
When to do
Perform this procedure when dust or other stains are found on the components.
Materials required
Clean gauze, neutral wash solution, and deionized water
System status
Make sure that the system status is not Running.
Precautions
WARNING
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.
BIOHAZARD
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.
How to do
1 Make sure that the system is not running tests, and then open the protective shield.
2 Use clean gauze moistened with ethanol to clean the analyzer panels and carousel
covers.
3 Use wash solution to clean the touchscreen and keyboard.
4 Restore the protective shield.
5 Select Utility-Maintenance-Maintenance and then select Scheduled
Maintenance-Other.
6 Mark the Select checkbox to the right of Clean Analyzer Panels.
8 Select Log, and then record comments and other important information for the
procedure.
10 Click the analyzer icon to enter the system overview screen and then select Home
F4 to put the instrument into the Standby status.

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15 Maintenance
15.9.2 Clean Reagent Carousel

When reagents are sprayed into the reagent compartment or dusts accumulate inside the
compartment, clean them immediately in order to minimize the risks of carryover.
Purpose
To clean the reagent carousel assembly to ensure clean operating environment and
eliminate the risks of carryover.
When to do
Perform this procedure when reagents are spilt into the reagent compartment or dust is
found inside of it.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system status is Stopped or Standby.
Precautions:
WARNING
Do not spill water or ethanol into the reagent compartment to prevent equipment
damage.
BIOHAZARD
Dispose of the used gauze in accordance with your local or national guidelines for
biohazard waste disposal.
How to do
1 Make sure that the system is in Stopped or Standby status.
2 Remove the reagent carousel cover, remove all the reagents for refrigeration.
3 Use clean gauze to wipe the glass of the bar code scanning window of the reagent
carousel, and if necessary, use the gauze moistened with ethanol or deionized water
to wipe the glass. Make sure that no traces or dusts remain.
4 Use clean gauze soaked with deionized water or ethanol to clean the reagent
carousel, then use cotton swabs dipped with ethanol to clean the reagent positions.
5 Restore the carousel cover.
Maintenance – Other.
7 Mark the Select checkbox to the right of Clean Reagent Carousel.
procedure.

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15 Maintenance
15.9.3 Replace Syringe

The syringe may have leak or other phenomena causing inaccurate
aspirating/dispensing and resulting in unreliable results.
Purpose
To replace the syringe assembly to ensure optimal measuring performance.
When to do
Perform this procedure when the syringe has leak or other abnormal phenomena.
Materials required
Deionized water, beaker, and syringe assembly
System status
Make sure that the system status is standby or incubation.
Precautions:
BIOHAZARD
How to do
1 Prepare a new syringe assembly and washer, and then moisten the washer in the
deionized water.
3 Choose Syringe Maintenance.The Syringe Maintenance maintenance guide
window pops up.
Figure 15.11 Syringe Maintenance
right rear of the analyzer and remove the cover. You can see the syringe as shown in
the figure below:.

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15 Maintenance
Figure 15.12 Sample syringe and reagent syringe
T piece
15 scales
Retaining
screw
Fixing
block
Retaining screw
Plunger guide gap
5 Loosen counterclockwise the four retaining screws on top of the syringe, and then
remove the screws and the fixing blocks.
6 Loosen counterclockwise the retaining screw at the bottom of the syringe and then
remove it.
7 Hold the T piece with one hand and the syringe connector with the other hand.
Loosen the syringe counterclockwise and then remove the washer.
8 Soak the new syringe connector in the deionized water beaker, pull the plunger head
to aspirate half syringe of deionized water, and then push the plunger head to
remove the air.
9 Put the new washer in the T piece. Hold the T piece with one hand and the syringe
connector with the other hand, and then screw the T piece clockwise.
10 Install the syringe on the bracket.
11 Install the fixing blocks and 4 retaining screws while having the retaining screws not
tightened.
12 Align the plunger head to the retaining screw at the bottom of the syringe, and then
tighten clockwise the retaining screw.
13 Pinch the plunger guide cap to adjust the syringe height. Make the syringe head over
the upper fixing block for 15 scales.
14 Tighten the four retaining screws on the fixing blocks.
15 After finishing the replacement, select Continue. The system resets the syringe unit.
Check if the new syringe, guide tube and connectors have leak. If it does, perform the
Check Syringes procedure to check the syringe.
17 Mark the Select checkbox to the right of Replace Syringe.
18 Select Ok to refresh the current date as the performance date.
procedure.

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15 Maintenance
NOTE
If the tube connection is loose or leakage occurs, please tighten the connectors or
contact our customer service department; otherwise the leakage may cause system
failure.
15.9.4 Clean Probe Interior

The probe, once blocked, cannot aspirate or dispense sample/reagent correctly. When
you find that the probe is clogged and cannot aspirate or dispense sample/reagent, or
when the probe is detected with abnormal liquid flow, probe interior should be cleaned.
Purpose
To clean the interior of the probe and avoid clogging.
When to do
Perform this procedure when you find that the probe is clogged and cannot aspirate or
dispense sample/reagent, or when the probe is detected with abnormal liquid flow.
Materials required
Unclogging device, small slot-head screwdriver, small Philips-head screwdriver, beaker,
deionized water, and unclogging device for probe
System status
Precautions:
BIOHAZARD
How to do
1 Switch off the analyzer power and open the upper protective shield of the analyzer.
Command.
3 Choose Clean/Replace Probe, the Clean/Replace probe window pops up. Select
Continue.

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15 Maintenance
Table 15.5 Clean/replace probes
4 Loose the screw at the lower rear of the arm cover and remove the cover from the
arm base.
5 Press the circuit board with one hand and unplug the white connector with the
other hand.
6 Use cross screw driver to remove the liquid level sense board.
7 Use a slot-head screwdriver to remove the retaining screw from the probe and take
out the spring.
8 While holding the connector on the probe with one hand, unscrew the tube
connector counterclockwise with the other hand until the tube connector is
disconnected. Remove the tube from the probe gently.
9 Remove the probe from the arm gently.

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15 Maintenance
Remove
the board
Unplug the
connector
Loosen
Retaining
tube joint
screw
Remove the
retaining
screws
Remove
the probe
10 Connect the unclogging device to the probe, fill the syringe with deionized water and
then connect it to the unclogging device. Put the probe inside the beaker while
keeping the probe tip not contacting the beaker. Push the syringe to rinse the
interior of the probe. Repeat this step for 10 times.
If the syringe plunger leaks and the probe cannot be unclogged due to serious
blockage, replace the probe.
11 When continuous water flow comes out of the probe in the same direction with the
probe, it indicates the cleaning procedure is finished successfully. Remove the
unclogging device. Discharge the liquid inside by waving the probe and dry its
exterior.
12 Insert the probe downwards into the hole on the probe arm.
13 Connect the tube connector to the probe and then tighten it clockwise.
14 Install the liquid level sense board on the arm and connect the probe connector to
the liquid level detection board.
15 Insert the screw with the spring into the screw hole and tighten the retaining screw.
Pay attention to the spring direction and make the thread opening face downwards.

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15 Maintenance
16 Pinch the probe by the part near the probe arm. Push the probe upwards and then
release it to check if the spring works well.
 If it does, proceed to the next step.
 If not, check if the spring is clamped or fixed too tightly.
17 After maintenance, click Continue and then check if the No.D2 LED indicator on the
circuit board inside the probe arm is lit.
 If it is, the liquid level detection system is normal.
 If not, contact our customer service department or your local distributor.
18 Install the probe arm cover properly and then tighten the screw on it.
19 Pinch the probe by the part near the probe arm. Push the probe upwards and then
release it to check if the spring works well.
 If it does, proceed to the next step.
 It not, it indicates that the arm cover is not installed correctly. Reinstall the arm
cover and check the spring until it can move freely.
20 Select Finish. The system resets the probe automatically. Remove the objects within
the moving part tracks in case collision occurs.
21 Check if the liquid flow coming out of the probe is continuous and in the same
direction as the probe. If not, perform Check probe procedure to troubleshoot the
problems. Check the guide tube connectors for leakage. If leakage occurs, tighten the
connector.
Maintenance - Other.
23 Mark the Select checkbox to the right of Clean Probe Interior.
procedure.
NOTE
failure.
15.9.5 Replace Probe

Replace the probe when it is damaged and cannot be repaired, or blocked seriously, or
bent.
Purpose
To replace the probe.
When to do
Perform this procedure when the probe is damaged and cannot be repaired due to the
following causes, such as serious blockage, or bending.
Materials required

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15 Maintenance
Small slot-head screwdriver, small Philips-head screwdriver and new probe
System status
Make sure that the system status is Standby or Failure.
Precautions
WARNING
caution when working around the probe.
BIOHAZARD
How to do
1 Remove the probe by referring to Step 1-9 in 15.9.4 Clean Probe Interior.
2 Insert the probe downwards into the hole on the probe arm.
3 Install and check the probe by referring to Step 13-21 in 15.9.4 Clean Probe Interior.
5 Mark the Select checkbox to the right of Replace Probe.
procedure.
NOTE
failure.
15.9.6 Remove Air Bubbles in Syringe

Purpose
To remove the air bubbles possibly existing inside the syringe.
When to do
Perform this procedure when you find air bubbles inside the syringe.
Materials required
System status
Make sure that the system status is Standby and incubation
How to do

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15 Maintenance
Command.
2 Choose Syringe Maintenance.The Syringe Maintenance maintenance guide
window pops up. Select Continue.
right rear of the analyzer and remove the cover. You can see the syringe.
4 Loosen counterclockwise the four retaining screws on top of the syringe, and then
remove the screws and the fixing blocks.
5 Loosen counterclockwise the retaining screw at the bottom of the syringe and then
remove it.
6 Hold the T piece with one hand and the syringe connector with the other hand.
Loosen the syringe counterclockwise and then remove the washer.
7 Soak the syringe connector in the deionized water beak, pull the plunger head to
aspirate half syringe of deionized water, and then push the plunger head to remove
the air.
8 Put the washer in the T piece. Hold the T piece with one hand and the syringe
connector with the other hand, and then screw the T piece clockwise.
9 Install the syringe on the bracket.
10 Install the fixing blocks and 4 retaining screws while having the retaining screws not
tightened.
11 Align the plunger head to the retaining screw at the bottom of the syringe, and then
tighten clockwise the retaining screw.
12 Pinch the plunger guide cap to adjust the syringe height. Make the syringe head over
the upper fixing block for 15 scales.
13 Tighten the four retaining screws on the fixing blocks.
14 After finishing the replacement, select Continue. The system resets the syringe unit.
Check the new syringe for leak and bubbles, and if there is, perform the Check
Syringe procedure.
15 Perform Probe Wash Cycle for 15 times.

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15 Maintenance
17 Mark the Select checkbox to the right of Remove Air Bubbles in Syringe.
procedure.
NOTE
failure.
15.9.7 Bar Code Maintenance

This maintenance procedure is used to clean the sample and reagent bar code scanning
windows in order to avoid influencing bar code scanning. When sample rack bar code
label is damaged and cannot be read normally, replace it immediately.
Purpose
To clean the glass of the sample and reagent bar code scanning windows in order to avoid
influencing bar code scanning.
When to do
This maintenance should be performed if the glass of the sample or reagent bar code
scanning window is contaminated and causes bar code scanning failure.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system is not running any tests.
Precautions
BIOHAZARD
CAUTION
Exercise caution not to spray water or ethanol or other liquids on the glass of the bar
code scanning window. Avoid dropping water or ethanol in samples.
How to do – Sample bar code scanning window

1 Open the upper protective shield and remove the panel above the sample rack lanes.
2 Use clean gauze to wipe the glass of the bar code scanning window, and if necessary,
dip the gauze with little ethanol or deionized water to wipe the glass. Make sure that
no traces or dusts remain.
3 Restore the panel.
How to do – Sample rack bar code label
1 Remove the old rack bar code label and rack ID label.

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15 Maintenance
Figure 15.13 Removing old rack bar code label
2 Apply a new rack bar code label on the front concave side of the rack, and then find
the corresponding rack ID label and apply it on the end of the rack.
NOTE
Please apply rack bar code label to the rack’s front side on the round end, and
ensure the label is aligned with the protruded edge in order to avoid bar code
scanning failure.
Figure 15.14 Applying new rack bar code label
Figure 15.15 Applying relevant rack ID label
3 Check that the new bar code label is consistent with the rack ID label.
How to do – Reagent bar code
2 Press the reagent carousel load button to rotate the empty reagent position to the bar
code scanning window. If there are no empty reagent positions, unload the reagent to
vacate a position and rotate it to the scanning position.

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15 Maintenance
3 Use clean gauze to clean the bar code scanning window inside the reagent
compartment. If necessary, you can use gauze soaked with ethanol or deionized
water. Make sure that there is no trace or dust left on the glass.
5 Mark the Select checkbox to the right of Bar Code Maintenance.
procedure.
15.9.8 Discard Cuvettes

Auto cuvette discarding maintenance is used to clear all the remaining cuvettes in the
dilution position, mixing position and on the reaction carousel and the dispersion
carousel. It will take about 5 minutes.
Command.
2 Select Discard Cuvette.
Table 15.6 Discard cuvettes
3 Select Execute.
4 After discarding cuvettes, select Exit to exit the window.
6 Mark the Select checkbox to the right of Discard Cuvettes.
procedure.

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15 Maintenance
15.9.9 Fluidic Prime

Fluidic Prime is used to prime the washing and sampling tubing, dispersion dispensing
tube and substrate dispensing tube in order to remove the bubbles and clean the tubes.
Purpose
To prime the washing and sampling tubing, dispersion dispensing tube and substrate
dispensing tube in order to remove the bubbles and clean the tubes.
When to do
Perform this maintenance when air bubbles exist in the tube or when tube needs
cleaning.
How to do
2 Select Fluidic Prime.
Figure 15.16 Fluidic Prime
3 Select the fluidic prime type and set the probe wash cycle, dispersion cycle and
substrate prime cycle.
4 If you want to execute substrate prime, select substrate path.
5 Select Execute.
6 To stop priming, select Stop.
9 Mark the Select checkbox to the right of Fluidic Prime.
procedure.

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15 Maintenance
15.9.10 Clean the Cap of Wash Buffer Tank

Purpose
To prevent the wash buffer from dropping onto the cap of the wash buffer tank which
may cause crystallization and clogging of the air vent on the cap.
When to do
Perform the procedure after loading the wash buffer.
Materials required
Clean tissue, deionized water or ultra-pure water ,Tip head
System status
Make sure that the system status is not running.
Precautions:
WARNING
During the cleaning process, any pollutants like foreign substances, dirt, etc. are not
allowed.
BIOHAZARD
How to do
1 After changing the wash buffer, use clean tissue to wipe the spilt wash buffer away
on the cap in case the wash buffer drops onto other parts or causes crystallization
which may clog the air vent on the cap.
2 When the air vent of the cap is found to be clogged, remove the cap and use clean tip
head to gently strip the blockage; use DI water or ultra-pure water to clean it and
wipe it dry with clean tissue. Reinstall the cap. During the process, any foreign
substances are not allowed to drop into the wash buffer tank or adhere to the cap
assembly.

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15 Maintenance
Figure 15.17 Clean the Cap of Wash Buffer Tank
Air vent

4 Mark the Select checkbox to the right of Clean the Cap of Wash Buffer Tank.
procedure.
15.9.11 Clean Dispersion Aspirate Probes

Aspirate probe contamination will result in carryover and aspirate probe clogging will
result in wash solution residue, which will affect the test result. It is required to replace
clean aspirate probe regularly.
Purpose
Replace the aspirate probe with a clean one; clean the replaced probe for spare use.
When to do
This procedure should be performed after 2,500 infectious disease chemistries or 5,000
routine chemistries
Materials required
4 clean aspirate probes, clean gauze or alcohol-cotton(four pieces), ethanol, deionized
water or distilled water, CD80 wash solution, and 3 beakers, Cleaning tool for dispersion
probes(Unclogging device and syringe)
System status
Precautions:

Operator's Manual
15 Maintenance
WARNING
caution when working around the probes. Exercise caution while working around the
aspirate probe. If it is bent or damaged, replace it immediately; otherwise, unreliable
results may be obtained.
BIOHAZARD
NOTE
Take caution and do not bend the dispersion aspirate probe.
How to do
How to do
1 Select Utility-Maintenance-Maintenance and then select Maintenance
Command.
2 Select Clean Dispersion Probes/Tubes command.
3 Open the upper protective shield of the analyzer.
4 Select Continue.
5 Take A1 as example. Unscrew the round nut of A1 on the aspirate/dispense plate
counter-clockwise and lift it upward,, pull the aspirate probe from the dispersion
carousel. Do not bend or bump the probes.
A1 round
nut
6 Loosen counter-clockwise the quick joint on the panel behind the dispersion
carousel , lift it gently and disconnect the tube.

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15 Maintenance
A1
joint
7 Use gauze soaked with ethanol or alcohol-cotton to clean the exterior of the replaced
aspirate probe, and use the unclogging device to clean its interior. After exterior
cleaning, connect the syringe tool (included in the accessory kit) with the quick joint
of the aspirate probe.
Prepare a beaker full of CD80 wash solution, immerge the other end of the probe
into the beaker, and push/pull the syringe plunger for over 10 times. Lift the probe
tip above the liquid level and discharge the liquid in the tube and prepare another
beaker filled with deionized water or distilled water, immerge the probe tip into the
liquid, pull the syringe plunger to aspirate liquid, put the probe into another empty
beaker and push the syringe plunger to discharge the liquid.
Repeat this action for at least 10 times to clean the probe interior. After interior
cleaning, disconnect the probe assembly from the syringe connector, swing the
probe and tube to remove the liquid leftover, and then use clean gauze (without
scraps) to dry the probe exterior. Please note that the tube is connected tight during
the cleaning process.
8 Repeat step 5~7 to change the other three probes; click Continue .
9 After the aspirate probes are dried, install clean aspirate probes back onto the
aspirate/dispense plate. Please pay attention to prevent the probe from bumping
and scratching other components. Tighten clockwise the round nut and the aspirate
probe. Lift the aspirate probe gently to check if it can spring back smoothly.
Connect the quick joint of the aspirate probe guide tube with the corresponding
joint on the panel behind the dispersion carousel When connecting them, press the
joints gently and screw them clockwise until the buckle of the joints are fastened and
a click is heard. Check if the joint is fastened by shaking it gently. Fix the guide tube
onto the press plate and the tube symbol on the guide tube should align with the
edge of the press plate.
10 Select Done. The dispersion unit resets automatically.
Maintenance – Irregular.
12 Mark the Select checkbox to the right of Clean Aspirate Probes. select OK to
refresh the current date as the performance date.
procedure. Select OK to save your input information.

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15 Maintenance
14 After replacement, select Maintenance Command - Fluidic Prime, select the
Dispersion Cycle check box and set the cycle to 5, and then click on the Execute
button. Observe the dispersion aspirate probe during the priming and ensure that
the probe has been replaced correctly without tube leakage.
15 Close the upper protective shield of the analyzer.
NOTE
If the guide tube is loose or leakage occurs, please contact our customer service
department, otherwise the leakage may cause system failure.

Operator's Manual
16 Alarms and Troubleshooting
The following pages describe how to view and edit error logs and edit logs, and how to
locate failure and determine relevant corrective actions. Read this chapter thoroughly to
achieve the best performance of the instrument.

Operator's Manual
16.1 Classification of Logs

16.1.1 Introduction
The logs provided by the system are divided into:
 Error Log
 Edit Log
16.1.2 Error Log

Error code
Each error has a unit code used for identification and locating probable causes and
solutions. An error code consists of 6 letters and numbers, such as “C01001”, in which “C”
indicates that the error occurs on the operation unit, “01” is the error description of
instrument connection, and “001” is the serial number of the error. Therefore, “C01001”
is described as “the first error of instrument connection on the operation unit”.
The following tables provide a summary of error codes for the operation unit and
analyzing unit.
Table 16.1 Error code of the operation unit
Range Description
C Indicates that the error occurs on the operation unit.
00-99 Indicates the specific component on which the error occurs.
 00-Operating system
 01-Instrument communication
 02-Database
 03-Result calculation
 04-Sample bar code
 05-Reagent bar code
 06-LIS host
 07-Consumable
 08-Rack feeder system
 09-Analyzer performance
000-999 Serial number of the error
Table 16.2 Event ID of the analyzing unit

Range Description
A Indicates that the error occurs on the analyzing unit.
50-61 Indicates the specific component on which the error occurs.
 50- Rack feeder system
 51-Probe
 52-Reagent carousel
 53-Reaction carousel
 54-Photometer

Operator's Manual
 55- Gripper
 56-Dispersion aspirating
 57- Dispersion dispensing
 58- Dispersion carousel
 59-Hydro system
 60-Temperature control
 61-refrigeration
000-999 Serial number of the error.
Online help
Every error log is provided with online help information. Select the icon in front of
an error log. The descriptions, possible causes and solutions of the error are displayed.
16.1.3 Edit Log

Edit logs record all deletions and part of editing actions performed by the user.
The delete logs record all deleting actions other than the error deletion. The edit logs
include editing of sample results and calibration factors.

Operator's Manual
16.2 Viewing and Handling Logs

All event logs are stored in folders named by the date when the logs are produced. The
system automatically compresses the event logs on the previous day and then removes
the relevant folder.
16.2.1 Description of Error Log Screen

Select Alarm in the function buttons area of the main screen. The Error Log screen is
displayed by default and shows all errors occurring on the current day.
Figure 16.1 Error Log screen
Every error log contains the event ID, date/time, error description (by processing
method), event class (by subsystem) and symptom.
Choose the following buttons as needed:
 Search F1: to search for error logs by date, event ID, symptom, or event class.
 Refresh F2: to refresh the error logs based on the current search conditions.
 Delete F3: to remove specified error logs on the screen.
 Diagnostics F6: to enter the diagnostics screen.
 Print F7: to print all error logs currently displayed on the screen.
16.2.2 Description of Edit Log Screen

Select Alarm-Edit Log. The Edit Log screen is displayed and shows all editing actions
occurring on the current day.

Operator's Manual
Figure 16.2 Edit Log screen
Every edit log contains the serial number, date/time, operator, event type and description.
Choose the following buttons as needed:
 Search F1: to search for edit logs based on the occurring date.
 Refresh F2: to refresh the edit logs based on the current search conditions.
 Delete F3: to remove specified edit logs on the screen.
 Print F7: to print all edit logs currently displayed on the screen.
16.2.3 Recalling Logs

Error logs and edit logs can be recalled by all users in any system status. Error logs can be
recalled by date, event ID, component and event type, while edit logs can only be recalled
by occurring date.
Perform the following steps to recall desired event logs:
1 Select Alarm-Error Log or Edit Log.
2 Select Search F1.
3 Enter one or more of the following conditions:
 Date
 Event ID (available for error logs only)
 Component (available for error logs only)
 Event type (available for error logs only)
4 Select OK. The event logs satisfying the conditions are displayed on the screen.
 Refresh F2: to refresh the logs based on the current search conditions.
 Delete F3: to remove specified logs on the screen.
 Print F7: to print all logs currently displayed on the screen.

Operator's Manual
16.2.4 Refreshing Logs

To refresh the event logs, perform the following procedure:
2 Select Refresh F2.
3 The system refreshes the logs based on the previous search conditions.
 New error logs are displayed chronologically and highlighted by different colors.
Yellow indicates a warning, and red indicates a serious error.
 New edit logs are displayed chronologically on the front-most of the log list.
 Delete F3: to remove specified logs on the screen.
 Print F7: to print all logs currently displayed on the screen.
16.2.5 Clearing Logs

Since the system has a limited storage capacity, you should clear and manage the event
logs regularly to ensure that the most-recent and important logs are kept.
Only users with sufficient permissions are allowed to delete event logs. For more
information about user permissions, refer to 3.1.7 User Accounts and Permissions
(page3-7).
Perform the following steps to clear event logs:
2 Search for desired event logs.
3 Select event logs you desire to delete.
4 Select Delete F3.
5 Select OK. To abort the deleting, select Cancel.
When you confirm the deleting, the system removes the selected event logs from the
screen.
16.2.6 Printing Logs

After searching for desired logs on the Error Log or Edit Log screen, select Print F7. The
event logs currently displayed are printed out in the same format as shown on the screen.
Printing logs will take a long time and requires a great number of papers. Think twice
before printing logs.

Operator's Manual
16.3 Error Troubleshooting

16.3.1 Introduction
When an error occurs, it will be indicated in many ways. The following pages describe
how to troubleshoot errors and help you determine solutions to such errors.
Generally, troubleshooting is divided into the following steps:
 An error occurs and is indicated in various ways.
 Check the error logs and component status.
 Identify the error and determine relevant solutions.
 Implement the solutions.
 Check and evaluate the implementation of the solutions.
16.3.2 Error Indications

Errors may occur on hardware, software and the entire system. When an error occurs, it
will be indicated in many ways to help identify it and determine the possible causes and
solutions. Errors can be indicated by alarm tone, alarm message, color, alarm message box,
result flag and error log, through which you will obtain detailed information about errors
and find the relevant solutions.
Alarm tone
When an error occurs, the buzzer gives alarm tone reminding you to notice the error and
take corrective actions. Alarm tone can be adjusted manually or silenced.
Perform the following steps to adjust the alarm tone:
1 Select Utility-System setup.
2 Adjust the alarm tone in the Alarm Volume field.
3 Test the alarm tone until it is satisfied.
4 To silence the alarm tone, drag the slider to the leftmost position of the scale.
5 Select Save F8 to save the adjustment.
Alarm message
When an error occurs, the system gives an alarm and displays the alarm message in the
second line of the prompt message area.
Color highlight
An error will be indicated by highlighting relevant buttons and screen texts with different
colors. Yellow indicates a warning, and red indicates a serious warning or error.
 Reagent button
 Utility button
 Alarm button
Select a button to access relevant function page, check for abnormities and take corrective
actions. When the problem is solved, the alarm indication disappears.

Operator's Manual
Alarm message box
An error can also be shown in an alarm message box, which contains the date/time, event
ID, time(s) and help icon.
Errors that are indicated through an alarm message box are divided into the following
types:
 Common error: including those that are indicated by warning the user, and by
invalidating tests, reagents and samples. When such error occurs, the alarm message
box shows with the title bar highlighted in yellow.
 Serious error: including those except for the common error. When such error occurs,
the alarm message box shows with the title bar highlighted in red, and you are only
allowed to reboot or exit the system.
When an alarm message box appears, select the Alarm button to view the new error logs,
analyze the possible causes and determine relevant corrective actions.
Flag
Flag is also called data alarm. When calibration error or failure, or sample result error
occurs due to the sample, reagent or system failure, a flag will appear near the
corresponding calibration result or sample results.
Error log
All alarms are recorded in the error logs. By recalling the error logs you are enabled to
master the current status of the system and troubleshoot errors.
16.3.3 Identifying Instrument Errors

To identify errors, understand the error indication thoroughly, check the error logs and
system status, and then determine relevant solutions.
The table below shows the error types that may occur on the system. Find relevant
corrective actions according to the description.
Table 16.3 Error types
Event Type Description
Instrument failure and Instrument failure and error may be detected on all
error subsystems and processed in different ways. Such errors
are shown in the Error messages and corrective actions
table, and can be identified through the event ID.
Data alarm Data alarm a flag indicating immunoassay test result
error. The flags are included in the Result flags table, and
can be identified through the flag symbol.

Operator's Manual
16.4 Data alarm
16.4 Data alarm

16.4.1 Introduction
Data alarm is a result flag indicating that an error or abnormity occurs to a result. By
identifying results flags can evaluate if the results are reliable and acceptable. Data alarm is
not necessarily an error but will definitely influence the result and should be considered
carefully.
The system provides monitoring of test results. When calibration error or failure, or
sample result error occurs due to the sample, reagent or system failure, a flag will appear
near the corresponding calibration result or sample results. The following pages
summary the result flags of the system.

Operator's Manual
16.4 Data alarm

Operator's Manual
16.4 Data alarm
16.4.2 Result Flags

Table 16.4 Result Flags
Flag Alarm Type Description Causes Corrective Actions
< Result Exceeds measuring Sample or control result exceeds the low limit of the Take no actions, or rerun the test for
related range low measuring range. confirmation.
> Result Exceeds measuring Sample or control result exceeds the high limit of the Rerun the test with diluted sample.
related range high measuring range.
^ Result Exceeds reference The result exceeds the high limit of the reference range. No actions are required.
related range high
^! Result Exceeds critical range The result exceeds the high limit of the critical range. No actions are required.
related high
v Result Exceeds reference The result exceeds the low limit of the reference range. No actions are required.
related range low
v! Result Exceeds critical range The result exceeds the low limit of the critical range. No actions are required.
related low
10x Result 10x Results of five runs (10 results), or 10 continuous results Check if the reagent is qualified,
related of a control are on the same side. control sample is normal, and the
instrument is working correctly.
12S Result 12S The current QC result is between ±2 and ±3 standard No actions are required.
related deviations from the assigned mean concentration.
13s Result 13s The current QC result is greater than ±3 standard Check if the reagent is qualified,
related deviations from the assigned mean concentration. control sample is normal, and the
22s Result 22s Results of two controls in the same run or two continuous Check if the reagent is qualified,
related results of a control are on the same side and greater than control sample is normal, and the
±2 standard deviations from the assigned mean instrument is working correctly.
concentration.
41s Result 41s Results of two runs (4 results), or 4 continuous results of a Check if the reagent is qualified,
related control are on the same side and greater than ±1 standard control sample is normal, and the
deviation from the assigned mean concentration. instrument is working correctly.

Operator's Manual
16.4 Data alarm

ABN Result Sample RLU out of Sample RLU is lower than the low absolute value (2500). Check the sample for foreign matters
related range or interferents; check if the reagent is
qualified and placed in the correct
position; check the substrate quality;
check the cuvette quality; check if the
photometric system is working
normally.
ADSE Calibration Sample RLU is abnormal The RLU slope is below 0. Rerun the test. If the flag is repeated
related after a rerun, please contact our
customer service department or your
local distributor.
CAL Result Corrected result The result is calculated based on the default calibration No actions are required.
related factors. (manually or automatically)
CALF Result Calibration status is not The reagent is not calibrated or calibration failed. Request and run the calibration.
related satisfied.
CALJ Result The calibration factors Use sample and control result gained by the rejected No actions are required.
related are rejected. calibration factor
CarOvr Result Potential carryover Potential carryover Rerun
related
COV Calibration Calibration curve not For nonlinear calibration, a satisfying base cannot be Check if the reagent and calibrator are
related convergent calculated and no calibration curve is drawn. qualified. Check if system status is
normal.
CSDB Result Air bubbles are 1.Substrate is insufficient. 1.Load the substrate.
related detected during 2.Substrate bottle or tube leaks. 2.Contact our customer service
substrate dispensing department or your local distributor.
process.
CSDB Calibration Air bubbles are 1.Substrate is insufficient. 1.Load the substrate.
related detected during 2.Substrate bottle or tube leaks. 2.Contact our customer service
substrate dispensing department or your local distributor.
process.
CVTM Result No cuvette tray loaded 1.No cuvette tray is loaded. 1.Load the cuvette tray.

Operator's Manual
16.4 Data alarm

related or no cuvettes. 2. There is no cuvette on the tray. 2.Change the cuvette tray.
3.Gripper error. 3. Home the system and run the test
again. If the error remains, contact
our customer service department or
your local distributor.
DCF Calibration DCF calibration failed. Photometer is aged. 1.Restart the analyzing unit and home
related the system.
2.If the error remains, contact our
local distributor.
DEL Result Deleted QC result The QC result has been deleted. No actions are required.
related
DET Calibration Calibration The calculated fit of the calibration curve exceeds the Check if the acceptance limit is
related determination specified limit. reasonable and the reagent and
coefficient out of range calibrator are normal, and then
recalibrate.
DEV Calibration Calibrator RLU Calibrator RLU deviation out of range, the check fails. Recalibrate.
related deviation out of range
DJAM Result Probe is clogged when Probe is clogged when aspirating diluted sample or the 1.Perform special wash procedure. If
related aspirating diluted probe is detected clogged in diluted sample position. the error remains, unclog the probe
sample. Clog detection sensor goes wrong. with unclogging device.
2.If the error still remains, contact our
local distributor.
DRGTB Result Probe bumps when 1.The cross cut of the diluent bottle is adherent. 1.Use the pipette tip to open the cross
related aspirating the diluent. 2.Probe aspirating reagent position parameters are not cut.
proper. 2.Readjust the probe position
3.The diluent bottle is not installed in place. parameters.
3. Reinstall the reagent bottle.
DRGTE Result Diluent is expired. Expired diluent is used in the sample or QC test. Change the diluent.
related

Operator's Manual
16.4 Data alarm

DRGTL Result Diluent is insufficient. 1.Diluent is not loaded. 1.Load the diluent.
related 2.Diluent is insufficient. 2.Remove the problematic diluent and
3.There are air bubbles in diluent bottle. discharge the air bubbles.
DRGTJ Result Probe is clogged when 1.There are clogs in the diluent. 1.Change the diluent.
related aspirating the diluent. 2. Probe error. 2.Home the system and rerun the test.
If the error remains, contact our
local distributor.
DTGL Calibration Insufficient special Wash solution is insufficient. Probe mistakenly detects 1.Load wash solution.
related wash solution the liquid level of the wash solution. 2.Home the system and rerun the test.
local distributor.
DUP Calibration Calibration Calibrator RLU repeatability out of range Check if the reagent and calibrator are
related repeatability check qualified. Check if the system status is
failed. normal.
EDT Result Edited result The result has been edited. No actions are required.
related
ERR Result Instrument error Instrument error Home the system and rerun the test. If
related the error remains, contact our
local distributor.
EXT Result Extended calibration The result is obtained by extending the calibration time. Take no actions, or recalibrate.
related factor
ICA Result The RLU is normal, but No calibration parameters Rerun it after calibration.
related results cannot be
calculated.
INDE Result Infectious disease The result of the infectious disease chemistry falls in the Take no actions, or rerun the test.
related chemistry gray area flag gray area.
LVC Calibration Calibration recursion Calibration recursion check failed. Check if the reagent and calibrator are
qualified. Check if the system status is

Operator's Manual
16.4 Data alarm

related check failed. normal.
MON Calibration Monotony check failed Calibrator RLU monotony check failed. Check if the reagent and calibrator are
related qualified. Check if the system status is
normal.
NOCUP Result No cuvette. No cuvette on the tray or the gripper grips nothing. No actions are required. Load the
related cuvettes and rerun the test.
NOID Result There are no sample ID Software error Contact our customer service
related in the test result department or your local distributor.
NREA Result Flag indicating the test The test result for infectious disease chemistry is No actions are required.
related result for infectious Negative.
disease chemistry is
Negative.
R Result Rerun result Retest the finished chemistry No actions are required.
related
R4S Result R4S One result of a run is greater than +2 standard deviations Check if the reagent is qualified,
related from the assigned mean and the other greater than -2SDs. control sample is normal, and the
RAT Calibration Signal ratio of the Signal ratio exceeds the fluctuation range defined in the Recalibrate.
related calibrator out of range, bar code.
the check failed.
RBMP Result Probe bumps with other The probe bumps with other object. No operation required or rerun the
related object when aspirating test.
the reagent and the
test is invalidated.
RCV Calibration Recovery regression Recovery regression check failed. Check if the reagent and calibrator are
related check failed. qualified. Check if the system status is
normal.
REAC Result Flag indicating the test The test result for infectious disease chemistry is Take no actions or rerun the test.
related result for infectious Positive.
disease chemistry is
Positive.

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16.4 Data alarm

REC Result Recalculate the sample The sample result is calculated manually with the latest No actions are required.
related results manually. calibration factors.
RGTB Result Probe bumps when 1.The cross cut of the reagent bottle is adherent. 1.Use the pipette tip to open the cross
related aspirating reagent 2.Probe aspirating reagent position parameters are not cut.
proper. 2.Readjust the probe position
3.The reagent bottle is not installed in place. parameters.
3. Reinstall the reagent bottle.
RGTE Result The reagent is expired. Sample and QC test result gained by expired reagent Replace the reagent.
related
RGTJ Result Probe is clogged when 1.There are clogs in the reagent. 1.Change the reagent bottle.
related aspirating the reagent 2.Probe error. 2.Home the system and rerun the test.
local distributor.
RGTL Result Insufficient reagent 1.Reagent is not loaded. Replace the reagent.
related 2.Reagent is insufficient. Remove the problematic reagent and
3.There are air bubbles in the reagent. discharge the air bubbles.
RGTL Calibration Insufficient reagent The calibration result is based on insufficient reagent. Replace the reagent.
related
RJAM Result Probe is clogged when Probe is clogged when aspirating the reagent or probe is Handle the reagent.
related aspirating the reagent. detected clogged in the reagent position.
Probe clog detection sensor goes wrong.
RMXH Result Vortex speed of Vortex speed of reaction liquid is too high during reaction 1. Rerun the operating software.
related reaction liquid is too liquid mixing process. 2. Restart the analyzing unit.
high. 3. If the error remains, contact our
local distributor.
RMXH Calibration Vortex speed of Vortex speed of reaction liquid is too high during reaction 1. Rerun the operating software.
related reaction liquid is too liquid mixing process. 2. Restart the analyzing unit.
high. 3. If the error remains, contact our

Operator's Manual
16.4 Data alarm

local distributor.
RMXL Result Vortex speed of Vortex speed of reaction liquid is too low during reaction 1. Rerun the operating software.
related dispersion wash buffer liquid mixing process. 2. Restart the analyzing unit.
mixing is too low. 3. If the error remains, contact our
local distributor.
RMXL Calibration Vortex speed of Vortex speed of reaction liquid is too low during reaction 1. Rerun the operating software.
related dispersion wash buffer liquid mixing process. 2. Restart the analyzing unit.
mixing is too low. 3. If the error remains, contact our
local distributor.
RRN Result Sample RLU out of Sample RLU exceeds the RLU at the maximum Rerun the test with diluted sample.
related range concentration of measuring range(sandwich method) or
is below the RLU at the maximum concentration of
measuring range(competition method)
SBMP Result The probe bumps with The probe bumps with other object. No operation required or rerun the
related other object and the test.
test is invalidated.
SHTE Result Sample transportation STM is jammed or hardware error Recover the failure. If this message
related error appears for 3 times, contact our
local distributor.
SJAM Result Probe is clogged Probe clogging is detected during sampling or the probe is Sample treatment
related clogged during sampling.
SLO Calibration Calibration slope check Calibration slope check failed. Check if the reagent and calibrator are
related failed. qualified. Check if the system status is
normal.
SMPB Result Probe bumps when 1.Sample tube is not uncapped. 1.Uncap the sample tube and rerun
related aspirating sample. 2.Sample tube is not properly placed. the sample.
3.Probe position parameters are incorrect. 2. Install the sample tube in place.

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16.4 Data alarm

4.Spring is aged; anti-bumping sensor is damaged or wire 3. Readjust the probe position
is broken. parameters.
4. Contact our customer service
SMPE Result Expired sample The sample is expired. Replace the sample.
related
SMPJ Result Probe is clogged when 1.There are clogs in the sample or the sample is too 1.Centrifuge the sample and rerun the
related aspirating sample viscous. test.
2.Sample is insufficient. 2.Add sample.
SMPL Result Insufficient sample 1.Sample is insufficient. 1.Refill the sample.

related 2. There are air bubbles in the sample. 2.Discharge the air bubbles.
SMPL Calibration Insufficient sample The sample is insufficient during analysis. Refill the sample.
related
SUBE Calibration Substrate is expired. Expired substrate is used to analyze the sample or Change the substrate.
related control.
Srr System System error 1.hydropneumatic subsystem alarm 1. Rerun the operating software.
related 2.Vortexer and dispersion mixing alarm 2. Restart the analyzing unit.
3. If the error remains, contact our
local distributor.
TNN Result Temperature error Temperature control is abnormal during test. 1.Rerun the operating software or
related restore the system.
2. Restart the analyzing unit.
3. If the error remains, contact our
local distributor.
VAM Calibration Calibration The calibration test is unfinished during calibration Check if the reagent and calibrator are
related completeness check process, causing the calibration factor cannot be qualified. Check if system status is
failed. calculated. normal.

Operator's Manual
16.4 Data alarm

WMXH Result Vortex speed of Vortex speed of dispersion mixing motor is too high. No actions needed. Rerun the test.
related dispersion mixing motor
is too high.
WMXH Calibration Vortex speed of Vortex speed of dispersion mixing motor is too high. No actions needed. Rerun the test.
related dispersion mixing motor
is too high.
WMXL Result Vortex speed of Vortex speed is too low during dispersion wash buffer No actions needed. Rerun the test.
related dispersion mixing motor mixing process.
is too low.
WMXL Calibration Vortex speed of Vortex speed is too low during dispersion wash buffer No actions needed. Rerun the test.
related dispersion mixing motor mixing process.
is too low.

Operator's Manual
16.5 Error Messages and Corrective Actions

Table 16.5 Error Messages and Corrective Actions
Error Component Event Error Message and Event Log Flag Probable Causes Corrective Actions
code Class
A22039 Other Error Unmatched software version. / 1. Executing version query Switch off the analyzing unit
instruction failed. power and switch on it again. If
2. Returned control software this message appears for 3 times,
version and that stored in the contact our customer service
operating software does not department or your local
match. distributor.
A50001 Rack feeder Error Rack feeder system Y axis losing / Rack feeder assembly Recover the failure. If this
system steps when passing the zero position jammed or hardware error message appears for 3 times,
contact our customer service
department or your local
distributor.
A50002 Rack feeder Error Rack feeder system Y axis losing / Rack feeder assembly Recover the failure. If this
system steps jammed or hardware error message appears for 3 times,
distributor.
A50003 Rack feeder Error Rack feeder system Y axis sensor / Rack feeder assembly Recover the failure. If this
system status error jammed or hardware error message appears for 3 times,
distributor.
A50004 Rack feeder Error No rack in the rack transportation / Rack feeder assembly Recover the failure. If this
system part during retrieving the rack jammed or hardware error message appears for 3 times,
distributor.

Operator's Manual
code Class
A50005 Rack feeder Error Feeding the rack in the rack / Rack feeder assembly Recover the failure. If this
system transportation part failed. jammed or hardware error message appears for 3 times,
distributor.
A50006 Rack feeder Error Rack feeder system X axis losing / Rack feeder assembly Recover the failure. If this
distributor.
A50007 Rack feeder Error Rack feeder system X axis sensor / Rack feeder assembly Recover the failure. If this
distributor.
A50008 Rack feeder Error Rack feeder system X axis losing / Rack feeder assembly Recover the failure. If this
system steps jammed or hardware error message appears for 3 times,
distributor.
A50009 Rack feeder Error Rack feeder system Z axis losing / Rack feeder assembly Recover the failure. If this
distributor.
A50010 Rack feeder Error Rack feeder system Z axis sensor / Rack feeder assembly Recover the failure. If this
distributor.
A50011 Rack feeder Error Rack found in lane %s during / Rack feeder assembly Recover the failure. If this

Operator's Manual
code Class
system retrieving the rack from rack jammed or hardware error message appears for 3 times,
transportation part contact our customer service
distributor.
A50012 Rack feeder Error Rack in lane %s is taken away while / Rack feeder assembly Recover the failure. If this
system feeding the rack. jammed or hardware error message appears for 3 times,
distributor.
A50013 Rack feeder Error Rack has already been on the rack / Rack feeder assembly Recover the failure. If this
system transportation part during feeding jammed or hardware error message appears for 3 times,
the rack. contact our customer service
distributor.
A50014 Rack feeder Error Retrieving the rack failed. / Rack feeder assembly Recover the failure. If this
system jammed or hardware error message appears for 3 times,
distributor.
A50015 Rack feeder Error No rack on the rack transportation / Rack feeder assembly Recover the failure. If this
system part during scanning bar code jammed or hardware error message appears for 3 times,
distributor.
A50016 Rack feeder Error Rack feeder system X axis finding / Rack feeder assembly Recover the failure. If this
system the zero position failed. jammed or hardware error message appears for 3 times,
distributor.
A50017 Rack feeder Error Rack feeder system Y axis finding / Rack feeder assembly Recover the failure. If this

Operator's Manual
code Class
distributor.
A50018 Rack feeder Error Rack feeder system Z axis finding / Rack feeder assembly Recover the failure. If this
distributor.
A50019 Rack feeder Error There is rack on the rack / Rack feeder assembly Recover the failure. If this
system transportation part during resetting jammed or hardware error message appears for 3 times,
the rack feeder system. contact our customer service
distributor.
A50020 Rack feeder Error Sample rack is found in scanning / Rack feeder assembly Recover the failure. If this
system channel during resetting the rack jammed or hardware error message appears for 3 times,
feeder system. contact our customer service
distributor.
A50021 Rack feeder Error No lane is available for the rack on / Rack feeder assembly Recover the failure. If this
system the rack transportation part during jammed or hardware error message appears for 3 times,
resetting the rack feeder system. contact our customer service
distributor.
A51001 Dispensing Error The mechanical zero position is not / Rack feeder assembly Recover the failure. If this
system found during probe vertical jammed or hardware error message appears for 3 times,
movement calibration. Position: contact our customer service
distributor.
A51002 Dispensing Error Probe's vertical movement deviation / 1. Zero position sensor goes Recover failure by performing the
system from the mechanical zero position is wrong or the wire of the Home maintenance procedure. If
larger than the required range. sensor is broken. this message appears for 3 times,
Position: 2. Probe assembly is blocked contact our customer service

Operator's Manual
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or jammed in vertical distributor.
direction.
3. The horizontal belt of the
probe assembly is loose or its
tension does not satisfy the
requirement.
A51003 Probe unit Error Probe collides with an obstacle / 1. Probe horizontal 1.Check if the probe is moving to
when moving vertically. Position: movement parameters are the middle position of the wash
wrong. well.
2. The threshold for vertical 2. Move the probe up and down
collision alarm is too small with hand and check if the
or the spring gets loose. threshold for vertical collision
3. Vertical collision sensor alarm is too small.
goes wrong or its wire is 3. If none of the above situation
broken. occurs, recover failure by
performing the Home
maintenance procedure. If this
message appears for 3 times,
distributor.
A51004 Probe unit Error Incorrect zero position sensor status / 1. The probe assembly is Recover failure by performing the
when probe is moving vertically. moved vertically by people. Home maintenance procedure. If
Position: 2. Zero position sensor goes this message appears for 3 times,
wrong or the wire of the contact our customer service
sensor is broken. department or your local
distributor.
A51005 Probe unit Error Alarm for probe vertical collision / 1. The probe is not recovered 1. Check if the probe is recovered
remains. Position: after collision. to its position. Move the probe up
2. Vertical collision sensor and down with your hand to see if
goes wrong or its wire is it can move smoothly.
broken. 2. If the probe is homed, recover

Operator's Manual
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failure by performing the Home
distributor.
A51007 Probe unit Error Probe collides with an obstacle / 1. Coder sensor goes wrong or Check if there is blocker in
when moving horizontally the wire of the sensor is horizontal direction. If so,
broken. remove it. Recover failure by
2. Probe assembly is blocked performing the Home
or jammed in horizontal maintenance procedure. If this
direction. message appears for 3 times,
3. The horizontal belt of the contact our customer service
probe assembly is loose or its department or your local
tension does not satisfy the distributor.
requirement.
4. Blocker is found in
horizontal direction.
A51008 Probe unit Error Incorrect zero position sensor status / 1. The probe assembly is Recover failure by performing the
when probe is moving horizontally moved horizontally by Home maintenance procedure. If
people. this message appears for 3 times,
2. Zero position sensor goes contact our customer service
wrong or the wire of the department or your local
sensor is broken. distributor.
A51009 Probe unit Error Probe's horizontal movement / 1. Monitoring position sensor Recover failure by performing the
deviation from the monitoring goes wrong or the wire of the Home maintenance procedure. If
position is larger than the sensor is broken. this message appears for 3 times,
requirement. 2. The probe is blocked or contact our customer service
jammed in the horizontal department or your local
direction. distributor.
3. The horizontal movement
belt gets loose.

Operator's Manual
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A51010 Probe unit Error Probe's horizontal movement / 1. The probe assembly is Recover failure by performing the
deviation from the mechanical zero moved horizontally by Home maintenance procedure. If
position is larger than the required people. this message appears for 3 times,
range. 2. Zero position sensor goes contact our customer service
wrong or the wire of the department or your local
sensor is broken. distributor.
3. Probe assembly is blocked
or jammed in horizontal
direction.
4. The horizontal belt of the
probe assembly is loose or its
tension does not satisfy the
requirement.
A51011 Probe unit Error The mechanical zero position is not / Probe vertical movement Recover failure by performing the
found during probe horizontal error Home maintenance procedure. If
movement calibration 1. Sensor status error. The this message appears for 3 times,
probe assembly is probably contact our customer service
forced to move department or your local
vertically.2.Zero position is distributor.
not found. The probe
assembly is probably
jammed.3. Collision occurs
during operation other than
aspirating. The probe
collides with other
object.4.Collision error
remains. The collision
remains.5.Vertical movement
is not allowed in current
horizontal position. The
probe moves vertically in an
unknown position.
Probe horizontal movement

Operator's Manual
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error
1.Sensor status error. The
probe assembly is probably
forced to move
horizontally.2.Failed to find
the mechanical zero position.
The probe assembly is
obstructed when
rotating.3.Collision occurs
during horizontal movement.
obstructed when
rotating.4.Horizontal
movement is not allowed in
current vertical position. The
forced to move vertically.
Syringe movement error
syringe assembly is probably
forced to move.2.Failed to
find the mechanical zero
position. The syringe
jammed.

Operator's Manual
code Class
A51013 Probe unit Error The mechanical zero position is not / Probe vertical movement Recover failure by performing the
found during syringe movement error Home maintenance procedure. If
calibration 1. Sensor status error. The this message appears for 3 times,
probe assembly is probably contact our customer service
forced to move department or your local
vertically.2.Zero position is distributor.
not found. The probe
jammed.3. Collision occurs
during operation other than
aspirating. The probe
collides with other
object.4.Collision error
remains. The collision
remains.5.Vertical movement
is not allowed in current
horizontal position. The
probe moves vertically in an
unknown position.
Probe horizontal movement
error
forced to move
horizontally.2.Failed to find
the mechanical zero position.
obstructed when
rotating.3.Collision occurs
during horizontal movement.
obstructed when
rotating.4.Horizontal

Operator's Manual
code Class
movement is not allowed in
current vertical position. The
forced to move vertically.
Syringe movement error
syringe assembly is probably
forced to move.2.Failed to
find the mechanical zero
position. The syringe
jammed.
A51014 Probe unit Error Syringe's horizontal movement / 1. Zero position sensor goes Recover failure by performing the
deviation from the mechanical zero wrong or the wire of the Home maintenance procedure. If
position is larger than the sensor is broken. this message appears for 3 times,
requirement 2. Wash syringe is blocked or contact our customer service
A51015 Probe unit Error Incorrect zero position sensor status / 1. The wash syringe is forced Recover failure by performing the
of syringe to move. Home maintenance procedure. If
2. Zero position sensor goes this message appears for 3 times,
distributor.
A51016 Probe unit Error The mechanical zero position is not / Zero position sensor goes Recover failure by performing the
found during interior wash syringe wrong or the wire of the Home maintenance procedure. If
calibration sensor is broken. this message appears for 3 times,

Operator's Manual
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distributor.
A51017 Probe unit Error Interior wash syringe's horizontal / 1. Zero position sensor goes Recover failure by performing the
movement deviation from the wrong or the wire of the Home maintenance procedure. If
mechanical zero position is larger sensor is broken. this message appears for 3 times,
than the requirement. 2. Wash syringe is blocked or contact our customer service
of interior wash syringe to move. Home maintenance procedure. If
distributor.
A51019 Probe unit Error The mechanical zero position is not / Zero position sensor goes Recover failure by performing the
found during exterior wash syringe wrong or the wire of the Home maintenance procedure. If
calibration sensor is broken. this message appears for 3 times,
distributor.
A51020 Probe unit Error Exterior wash syringe's horizontal / 1. Zero position sensor goes Recover failure by performing the
movement deviation from the wrong or the wire of the Home maintenance procedure. If
mechanical zero position is larger sensor is broken. this message appears for 3 times,
than the requirement. 2. Wash syringe is blocked or contact our customer service
of exterior wash syringe to move. Home maintenance procedure. If

Operator's Manual
code Class
distributor.
A51022 Probe unit Error Probe level detection board / 1. Level Sense Board goes Recover the failure. If this
communication error wrong. message appears for 3 times,
2.The wire and the connector contact our customer service
of the level sensor board are department or your local
not well connected or the distributor.
wire is broken.
A51023 Probe unit Warning Insufficient sample, Sample / 1.There is no sample or 1.Check if there is sufficient
position:, Sample ID/bar code: insufficient sample on the sample and sample is placed in
designated position. the position and run the test
2. Level Sense Board goes again;2.If the error remains,
wrong. perform probe level sense test on
the diagnostics screen. If level
sense test fails, please contact
our customer service department
or your local distributor.
A51024 Probe unit Error Sample is insufficient or contains air / 1.There is no sample or 1.Check if there is sufficient
bubbles, Position: ,Sample ID/bar insufficient sample on the sample and sample contains air
code designated position. bubbles and run the test
2.The sample contains air again;2.If the error remains,
bubbles. perform probe level sense test on
3. Level Sense Board goes the diagnostics screen. If level
wrong. sense test fails, please contact
A51025 Probe unit Error There are air bubbles in probe / 1.There are air bubbles in the Check if there are air bubbles in
subsystem or the concentration of probe tubing or the tube is the tubing. If so, perform fluidic
the wash solution is abnormal. empty. prime procedure. If not, recover
2. Level Sense Board goes the failure. If this message

Operator's Manual
code Class
wrong. appears for 3 times, contact our
customer service department or
A51026 Probe unit Error Probe clog detection board / 1. Probe clog detection board Recover the failure. If this
communication error. goes wrong. message appears for 3 times,
2.The wires of probe clog contact our customer service
detection board are not well department or your local
connected or the wires are distributor.
broken.
A51027 Probe unit Warning Sample is insufficient or contains / 1. The sample contains clots, 1. Check that the sample is
fibrins and clots or is too thick or insufficient. preprocessed correctly; or check
Position: 2. Probe is clogged. if the sample contains foreign
Sample ID/bar code: matters such as clot. If it does,
change the sample.2.Check if
there is sufficient sample. 3.
Perform the special wash
procedure. If the error remains,
remove the probe and use the
unclogging device to remove the
clog. 4. If the error remains after
the above steps, contact our
A51028 Probe unit Warning Probe is clogged in the diluting / 1. Probe is clogged. 1. Perform the special wash
position. 2. The clog detection sensor procedure. If the error remains,
goes wrong. remove the probe and use the
clog. 2.Contact our customer
service department or your local
distributor.
A51029 Probe unit Warning Probe is clogged in the wash / 1. Probe is clogged. 1. Remove the probe and use the
solution position. 2. The clog detection sensor unclogging device to remove the

Operator's Manual
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goes wrong. clog. 2.Contact our customer
distributor.
A51030 Probe unit Warning Probe is clogged during aspirating / 1. Air bubbles exist in the 1. Check if the reagent bottle
reagent. Reagent carousel position: reagent bottle. 2. The contains air bubbles, and then try
position: reagent bottle does not meet again. 2. Check if the reagent
the requirements. bottle meets the requirements.
3. If the error remains, contact
our Customer Service Department
A51031 Probe unit Error Probe is clogged during cleaning. / 1. Probe is clogged. 1. Perform the special wash
2. The clog detection sensor procedure. If the error remains,
distributor.
A51032 Probe unit Error Incorrect zero position sensor status / 1. Zero position sensor goes 1.Check if foreign matter falls off
of reaction liquid mixer wrong or its wire is broken. into the sensor.
2. Foreign matter falls off 2.Recover failure by performing
into the senor. the Home maintenance
procedure. If this message
appears for 3 times, contact our
A51033 Probe unit Error Reaction liquid mixer's deviation / Rack feeder assembly Recover the failure. If this
from the mechanical zero position is jammed or hardware error message appears for 3 times,
out of range. contact our customer service
distributor.
A51034 Probe unit Warning Vortex speed of reaction liquid is / Rack feeder assembly Recover the failure. If this
too low. jammed or hardware error message appears for 3 times,

Operator's Manual
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distributor.
A51035 Probe unit Warning Vortex speed of reaction liquid is / The assembly jammed or Recover the failure. If this
too high. resistance uneven or message appears for 3 times,
hardware error. contact our customer service
distributor.
A51036 Probe unit Warning Probe fails to detect liquid level in / 1. The concentrated wash 1.Check the volume of the wash
the wash solution position. solution is empty or its solution. If it is empty or less
volume is less than the dead than the dead volume, please
volume. add the wash solution.
2. Level Sense Board goes 2. If the wash solution is enough
wrong. but the error remains, please
3. The wires connecting level perform probe level sense test on
sensor board and the probe the diagnostics screen. If level
are not well connected or sense test fails, please contact
broken. our customer service department
A51038 Probe unit Warning Probe fails to aspirate the liquid in / Insufficient wash solution 1. Fill enough wash solution.
the wash solution position. 2. Level Sense Board goes 2. If the wash solution is enough
wrong. but the error remains, please
perform probe level sense test on
the diagnostics screen. If level
sense test fails, please contact
A51039 Probe unit Warning Reagent is insufficient or contains / 1. Air bubbles exist in the 1. Check if the reagent bottle
air bubbles. Reagent carousel reagent bottle.2. The reagent contains air bubbles, and then try
position: position: bottle does not meet the again. 2. Check if the reagent
requirements. bottle meets the requirements.
3. If the error remains, contact

Operator's Manual
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our Customer Service Department
A51041 Probe unit Error Probe level detection board self / 1.The probe is not properly 1. Check if the probe is installed
calibrating failed. installed. correctly and intact.
2. Level Sense Board goes 2. Recover the failure. If this
wrong. message appears for 3 times,
distributor.
A51042 Probe unit Error Analog circuit of probe clog / 1. Probe is clogged. 1. Perform the special wash
detection board is abnormal. 2. The clog detection sensor procedure. If the error remains,
distributor.
A52001 Probe unit Error Reagent carousel cover is opened. / The reagent carousel cover is Check if the reagent carousel
not installed correctly. cover is installed correctly and
make sure it is closed.
A52002 Probe unit Error Reagent carousel cover is opened; / 1. Reagent carousel cover is Check if the reagent carousel
reagent carousel movement failed. opened by people. cover is opened by people. If so,
2. The sensor for detecting close the reagent carousel cover.
the open/close of the reagent If not, open and close the reagent
carousel cover goes wrong or carousel cover again, recover the
the wire of the sensor is failure. If recover fails, please
broken. contact our customer service
distributor.

Operator's Manual
code Class
A52003 Probe unit Error Reagent carousel coder losing steps / Reagent carousel movement Recover the failure. If this
error. The reagent carousel is message appears for 3 times,
obstructed or blocked. contact our customer service
distributor.
A52004 Probe unit Error Reagent carousel losing steps while / Reagent carousel movement Recover the failure. If this
passing the zero position error. The reagent carousel is message appears for 3 times,
obstructed or blocked. contact our customer service
distributor.
A52005 Probe unit Error The mechanical zero position is not / Reagent carousel movement Recover the failure. If this
found during reagent carousel error. The reagent carousel is message appears for 3 times,
movement calibration. obstructed or blocked. contact our customer service
distributor.
A52006 Probe unit Error Reagent bar code reader does not / The reagent bar coder reader Recover the failure. If the error
work normally goes wrong due to system remains, initialize the sample bar
failure. code reader. If the error still
remains, contact our Customer
Service Department or your local
distributor.
A53001 Reaction Error Reaction carousel coder losing steps / Reaction carousel movement Switch off the analyzing unit
carousel error1.1.Failed to find the power and switch on it again.
home position The reaction Recover failure by performing the
carousel is obstructed or Home maintenance procedure. If
blocked. 2.The coder losing this message appears for 3 times,
step. The reaction carousel contact our customer service
is blocked or jammed. department or your local
3.Steps missed when moving distributor.
to the home position. The
reaction carousel is blocked
or jammed.

Operator's Manual
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A53002 Reaction Error The mechanical zero position is not / Reaction carousel movement Switch off the analyzing unit
carousel found during reaction carousel error1.1.Failed to find the power and switch on it again.
calibration. home position The reaction Recover failure by performing the
or jammed.
A53003 Reaction Error Reaction carousel losing steps when / Reaction carousel movement Switch off the analyzing unit
carousel moving to zero position error1.1.Failed to find the power and switch on it again.
home position The reaction Recover failure by performing the
or jammed.
A54001 Reaction Error The photon counting board does not / 1. The wires are not properly 1. Power off the analyzer and
carousel respond. connected. restart the analyzer.
2. Communication error. 2.Contact our customer service
3.The photon counting board department or your local
is damaged or its logic is distributor.
corrupted.
A54002 Reaction Error Failed to turn off the photometer / Communication error. 1. Power off the analyzer and
carousel PMT module. restart the analyzer.
2.Contact our customer service

Operator's Manual
code Class
distributor.
A54003 Reaction Error The photometer PMT module is not / 1. The wires are not properly 1. Power off the analyzer and
carousel turned on. connected. restart the analyzer.
corrupted.
A54004 Reaction Error Dark current count is out of range. / 1. The wires are not properly 1. Power off the analyzer and
carousel connected. restart the analyzer.
corrupted.
A54005 Reaction Error Failed to turn on the LED. / 1. The wires are not properly 1. Power off the analyzer and
carousel connected. restart the analyzer.
3. LED assembly is damaged. department or your local
distributor.
A54006 Reaction Error Failed to turn off the LED. / 1. Communication error. 1. Power off the analyzer and
carousel 2. LED assembly is damaged. restart the analyzer.
2.Contact our customer service
distributor.
A54007 Reaction Warning DCF is out of range. / Photometer is aged. Contact our customer service
carousel department or your local
distributor.
A54008 Reaction Warning DCF is violently fluctuating. / Photometer is aged. Contact our customer service
carousel department or your local

Operator's Manual
code Class
distributor.
A54009 Reaction Error The photometer dark current is / PD pre-amplification board is Contact our customer service
carousel high. aged. department or your local
distributor.
A54010 Reaction Error The photometer dark current is low. / PD pre-amplification board is Contact our customer service
carousel aged. department or your local
distributor.
A55001 Gripper Error The second gripper grips nothing.\n / The cuvette is deformed or Recover the failure. If this
Position: %s the gripper fingers do not message appears for 3 times,
move vertically. The cuvette contact our customer service
is adhered the hole of tray or department or your local
hardware goes wrong. distributor.
A55002 Gripper Error No cuvettes for the gripper to grip / The cuvette is deformed or Recover the failure. If this
position:%s(tray1 or 2, hole the gripper fingers do not message appears for 3 times,
position:) move vertically. The cuvette contact our customer service
A55003 Gripper Error Cuvette is adhering to Gripper. / The cuvette is deformed or Recover the failure. If this
Position: the gripper fingers do not message appears for 3 times,
A55004 Gripper Error Gripper losing the cuvette / The cuvette is deformed or Recover the failure. If this
the gripper fingers do not message appears for 3 times,
A55005 Gripper Error The mechanical zero position is not / Gripper assembly jammed or Recover the failure. If this
found during gripper vertical hardware error message appears for 3 times,
movement calibration. Position: contact our customer service

Operator's Manual
code Class
distributor.
A55006 Gripper Error Gripper's vertical movement / Gripper assembly jammed or Recover the failure. If this
deviation from the mechanical zero hardware error message appears for 3 times,
position is larger than the required contact our customer service
range. Position: department or your local
distributor.
A55007 Gripper Error Incorrect zero position sensor status / Gripper assembly jammed or Recover the failure. If this
when gripper is moving vertically hardware error message appears for 3 times,
Position: contact our customer service
distributor.
A55008 Gripper Error Gripper collides with an obstacle / Gripper assembly jammed or Recover the failure. If this
when moving vertically. Position: hardware error message appears for 3 times,
distributor.
A55009 Gripper Error Gripper losing steps detected by the / Gripper assembly jammed or Recover the failure. If this
middle vertical position sensor. hardware error message appears for 3 times,
Position: contact our customer service
distributor.
A55010 Gripper Error Gripper X axis finding the zero / Gripper assembly jammed or Recover the failure. If this
position failed. hardware error message appears for 3 times,
distributor.
A55011 Gripper Error Gripper Y axis finding the zero / Gripper assembly jammed or Recover the failure. If this
position failed. hardware error message appears for 3 times,

Operator's Manual
code Class
distributor.
A55012 Gripper Error Gripper X axis losing steps / Gripper assembly jammed or Recover the failure. If this
hardware error message appears for 3 times,
distributor.
A55013 Gripper Error Gripper Y axis losing steps / Gripper assembly jammed or Recover the failure. If this
hardware error message appears for 3 times,
distributor.
A55014 Gripper Error Gripper's X axis movement deviation / Gripper assembly jammed or Recover the failure. If this
from the mechanical zero position is hardware error message appears for 3 times,
larger than the requirement. contact our customer service
distributor.
A55015 Gripper Error Gripper's Y axis movement deviation / Gripper assembly jammed or Recover the failure. If this
from the mechanical zero position is hardware error message appears for 3 times,
larger than the requirement. contact our customer service
distributor.
when gripper is moving around X hardware error message appears for 3 times,
axis. contact our customer service
distributor.
when gripper is moving around Y hardware error message appears for 3 times,
axis. contact our customer service
distributor.

Operator's Manual
code Class
A55018 Gripper Error The mechanical zero position is not / Gripper assembly jammed or Recover the failure. If this
found during gripper finger hardware error message appears for 3 times,
movement calibration. contact our customer service
distributor.
A55019 Gripper Error Gripper's finger movement / Gripper assembly jammed or Recover the failure. If this
deviation from the mechanical zero hardware error message appears for 3 times,
position is larger than the contact our customer service
requirement. department or your local
distributor.
of gripper's fingers. hardware error message appears for 3 times,
distributor.
A56001 Dispersion Error Dispersion aspirate/dispense unit / Dispersion assembly Check if the assembly is jammed
losing steps when moving vertically. jammed or hardware error due to foreign objects on the
panel, recover the failure. If
this message appears for 3 times,
distributor.
A56002 Dispersion Error Dispersion aspirate/dispense unit / Dispersion assembly Check if the assembly is jammed
fails to find the zero position during jammed or hardware error due to foreign objects on the
vertical reset. panel, recover the failure. If
this message appears for 3 times,
distributor.
A56003 Dispersion Error Sensor status error when the / Dispersion assembly jammed Check if the assembly is jammed
vertical movement of dispersion or hardware error due to foreign objects on the
aspirate/dispense unit starts or panel, recover the failure. If

Operator's Manual
code Class
stops. this message appears for 3 times,
distributor.
A56004 Dispersion Error Dispersion Aspirating Pump is / Dispersion aspirate pump Contact our customer service
jammed. error department or your local
distributor.
A56005 Dispersion Warning Air bubbles are aspirated into / 1. Substrate is insufficient. 1.Check if substrate is sufficient.
Substrate Path 1/2;substrate bottle 2. The substrate bottle or If not, change the substrate.
1/2 has been unloaded. substrate tubing leaks. 2.If substrate is sufficient,
3.Airtightness of the contact our customer service
substrate tubing is poor. department or your local
distributor.
A57001 Dispersion Warning Air bubbles are detected during CSDB 1. Substrate is insufficient. 1.Check if substrate is sufficient.
substrate dispensing. 2. The substrate bottle or If not, change the substrate.
substrate tubing leaks. 2.If substrate is sufficient,
3.Airtightness of the contact our customer service
substrate tubing is poor. department or your local
distributor.
A57002 Dispersion Error Substrate syringe losing steps when / Wash buffer assembly Recover the failure. If this
passing the zero position jammed due to crystallization message appears for 3 times,
or hardware error contact our customer service
distributor.
A57003 Dispersion Error Sensor status error when the / Wash buffer assembly Recover the failure. If this
substrate syringe starts or stops jammed due to crystallization message appears for 3 times,
movement. or hardware error contact our customer service
distributor.

Operator's Manual
code Class
A57004 Dispersion Error Zero position is not found during / Wash buffer assembly Recover the failure. If this
substrate syringe resetting. jammed due to crystallization message appears for 3 times,
distributor.
A57005 Dispersion Error Substrate syringe exceeding the / Operation error or software Recover the failure. If this
extreme when moving error message appears for 3 times,
distributor.
A57006 Dispersion Error Dispersion dispense syringe losing / Wash buffer assembly Recover the failure. If this
steps when passing the zero position jammed due to crystallization message appears for 3 times,
distributor.
A57007 Dispersion Error Sensor status error when the / Wash buffer assembly Recover the failure. If this
dispersion dispense syringe starts or jammed due to crystallization message appears for 3 times,
stops or hardware error contact our customer service
distributor.
A57008 Dispersion Error Zero position is not found during / Wash buffer assembly Recover the failure. If this
dispersion dispense syringe jammed due to crystallization message appears for 3 times,
resetting. or hardware error contact our customer service
distributor.
A57009 Dispersion Error Dispersion dispense syringe / Operation error or software Recover the failure. If this
exceeding the extreme when error message appears for 3 times,
moving contact our customer service
distributor.

Operator's Manual
code Class
A57011 Dispersion Warning Substrate aspirating coupler signal / 1.Mis-operation. Check if the operation is correct.
exceeds the low or high limit. 2.The wires are not properly Check the wire connection. If the
connected. optical coupler or the PCB is
3.The optical coupler is damaged, contact our customer
damaged. service department or your local
distributor.
4.The PCB is damaged.
A57012 Dispersion Warning The change of substrate aspirating / 1.Mis-operation. Check if the operation is correct.
coupler signal is too small during 2.The wires are not properly Check the wire connection. If the
calibration. connected. optical coupler or the PCB is
distributor.
A57013 Dispersion Warning The target signal range of substrate / 1.Mis-operation. Check if the operation is correct.
aspirating coupler cannot be 2.The wires are not properly Check the wire connection. If the
reached after calibration. connected. optical coupler or the PCB is
distributor.
A57014 Dispersion Warning The calibration value of substrate / 1.Mis-operation. Check if the operation is correct.
aspirating coupler is out of range. 2.The wires are not properly Check the wire connection. If the
distributor.
A57015 Dispersion Warning Substrate aspirating coupler signal / 1.Mis-operation. Check if the operation is correct.
exceeds the range of attenuation 2.The wires are not properly Check the wire connection. If the
before calibration. connected. optical coupler or the PCB is
distributor.

Operator's Manual
code Class
A57016 Dispersion Warning Substrate dispensing coupler signal / 1.Mis-operation. Check if the operation is correct.
exceeds the low or high limit. 2.The wires are not properly Check the wire connection. If the
distributor.
A57017 Dispersion Warning The change of substrate dispensing / 1.Mis-operation. Check if the operation is correct.
coupler signal is too small during 2.The wires are not properly Check the wire connection. If the
calibration. connected. optical coupler or the PCB is
distributor.
A57018 Dispersion Warning The target signal range of substrate / 1.Mis-operation. Check if the operation is correct.
dispensing coupler cannot be 2.The wires are not properly Check the wire connection. If the
reached after calibration. connected. optical coupler or the PCB is
distributor.
A57019 Dispersion Warning The calibration value of substrate / 1.Mis-operation. Check if the operation is correct.
dispensing coupler is out of range. 2.The wires are not properly Check the wire connection. If the
distributor.
A57020 Dispersion Warning Substrate dispensing coupler signal / 1.The wires are not properly Check the wire connection. If the
exceeds the range of attenuation connected. optical coupler or the PCB is
before calibration. 2.The optical coupler is damaged, contact our customer
3.The PCB is damaged. distributor.

Operator's Manual
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A58001 Dispersion Error Dispersion carousel coder losing / Dispersion carousel Switch off the analyzing unit
steps movement error1.1.Failed to power and switch on it again.
find the home position The Recover failure by performing the
dispersion carousel is blocked Home maintenance procedure. If
or jammed. 2.The coder this message appears for 3 times,
losing step. The dispersion contact our customer service
carousel is blocked or department or your local
jammed. 3.Steps missed distributor.
when moving to the home
position The dispersion
carousel is blocked or
jammed.
A58002 Dispersion Error Zero position is not found during / Dispersion carousel Switch off the analyzing unit
dispersion carousel resetting. movement error1.1.Failed to power and switch on it again.
dispersion carousel is Home maintenance procedure. If
obstructed or blocked. this message appears for 3 times,
2.The coder losing step. The contact our customer service
dispersion carousel is blocked department or your local
or jammed. 3.Steps missed distributor.
jammed.
A58003 Dispersion Error Dispersion carousel losing steps / Dispersion carousel Switch off the analyzing unit
when moving to zero position movement error1.1.Failed to power and switch on it again.
dispersion carousel is Home maintenance procedure. If
obstructed or blocked. this message appears for 3 times,
2.The coder losing step. The contact our customer service
dispersion carousel is blocked department or your local
or jammed. 3.Steps missed distributor.

Operator's Manual
code Class
jammed.
A58004 Dispersion Warning Vortexer motor has too high rotation / The resistance of vortexes Recover the failure. If this
speed. assembly is uneven and the message appears for 3 times,
assembly may be partially contact our customer service
jammed or hardware goes department or your local
wrong. distributor.
A58005 Dispersion Warning Vortexer motor has too low rotation / The resistance of vortexes Recover the failure. If this
speed. assembly is uneven and the message appears for 3 times,
wrong. distributor.
A58006 Dispersion Warning Vortexer rotation speed is / The resistance of vortexes Recover the failure. If this
abnormal. assembly is uneven and the message appears for 3 times,
wrong. distributor.
A59001 Hydropneumatics Warning Wash buffer is used up. Please load / Wash buffer is exhausted. Please load wash buffer.
wash buffer.
A59002 Hydropneumatics Error Floater logic error of buffer tank. / Floater of the buffer tank of 1. Check if the error is
wash buffer is abnormal. accidental.
2. If the error is not accidental,
distributor.
A59003 Hydropneumatics Error Buffer tank of wash buffer solution / 1. Inlet system error. 1. Check if the error is
is empty. 2.Floater of the buffer tank accidental. If not, contact our
of wash buffer is abnormal. customer service department or

Operator's Manual
code Class
A59004 Hydropneumatics Error Wash buffer tank is filled slowly. / 1. Inlet system error. Contact our customer service
2.Floater of the buffer tank department or your local
of wash buffer is abnormal. distributor.
A59005 Hydropneumatics Error The waste tank is full. / 1.The waste tank is full. 1.Check if the waste tank is full.
2.The floater of waste tank If so, empty it.
goes wrong. 2. If the waste tank is not full and
the error is not accidental,
distributor.
A59006 Probe unit Error Waste pump vacuum capacity is / 1.Waste pump P02 goes 1. Check if the error is
insufficient. wrong. accidental.
2. Solenoid Valve SV09 or 2. If the error is not accidental,
SV10 error. contact our customer service
3.Tubing are leaking. department or your local
distributor.
4.The vacuum pressure
sensor goes wrong.
A59007 Probe unit Error Probe wash vacuum is abnormal. / 1.Waste pump P02 goes 1. Check if the error is
wrong. accidental. 2. If the error is not
2.Tubing are leaking. accidental, contact our customer
3.The vacuum pressure service department or your local
sensor goes wrong. distributor.
A59008 Probe unit Error Releasing vacuum abnormal. / 1. Solenoid valves V23-V27 go 1. Check if the error is
wrong. 2. The vacuum pump accidental. 2. If the error is not
goes wrong. 3. The vacuum accidental, contact our customer
sensor goes wrong. service department or your local
distributor.

Operator's Manual
code Class
A59009 Probe unit Error Probe wash vacuum is insufficient. / 1.Waste pump P02 goes 1. Check if the error is
wrong. accidental. 2. If the error is not
2.Solenoid valve SV09 error. accidental, contact our customer
3.Tubing is clogged. service department or your local
distributor.
4.The vacuum pressure
sensor goes wrong.
A59010 Probe unit Error Probe interior wash pressure is too / 1. The probe interior wash 1. Check if the error is
low. syringe SR02 goes wrong. accidental. 2. If the error is not
2.1. The probe interior wash accidental, contact our customer
valve SV02 goes wrong. service department or your local
3.The probe interior wash distributor.
tubing is leaking.
A59011 Probe unit Error Wash solution overflowing / 1. The vacuum pump failed. Contact our customer service
2. The valve goes wrong. 3. department or your local
Level Sense Board goes distributor.
wrong.
A59012 Probe unit Error Reagent carousel discharging liquid / 1. Waste discharge valve SV10 1. Open the reagent carousel
failed. goes wrong. cover and check if the discharge
Reagent carousel discharge hole is clogged.
hole is clogged. 2. If the discharge hole is not
clogged, recover failure by
performing the Home
distributor.
A59999 / Error System resetting failed. / System resetting failed. Execute Home procedure: reboot
PC and the analyzer. If this

Operator's Manual
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distributor.
A60001 Temperature Error Reaction carousel temperature is TNN 1.The ambient temperature 1. Check if the error is
Control out of range.TDISP temperature: is out of range. 2. The accidental. 2. If the error is not
temperature sensor goes accidental, contact our customer
wrong. (component error, service department or your local
cable error) 3. The distributor.
temperature protection
switch goes wrong.
(component error, cable
error) 4.The heater goes
wrong. (component error,
cable error) 5. PCB error
6. Parameters are lost. 7.
Electromagnetic interference
exists.
A60002 Temperature Error Dispersion carousel temperature is / 1.The ambient temperature 1. Check if the error is
Control out of range. is out of range. 2. The accidental. 2. If the error is not
TDISP temperature: temperature sensor goes accidental, contact our customer
switch goes wrong.
exists.

Operator's Manual
code Class
A60003 Temperature Error Substrate preheating temperature is / 1.The ambient temperature 1. Check if the error is
switch goes wrong.
exists.
A60004 Temperature Error Incubation failed because reaction / Reaction carousel Power off the analyzer and
Control carousel temperature is out of temperature is not in the set restart analyzing unit and the
range. range after incubation. computer. If three continuous
TDISP temperature: attempts are failed, contact our
Customer Service Department or
A60005 Temperature Error Incubation failed because the / Dispersion carousel Power off the analyzer and
Control dispersion carousel temperature is temperature is not in the set restart analyzing unit and the
out of range. range after incubation. computer. If three continuous
A60006 Temperature Error Incubation failed because the / Substrate preheating Power off the analyzer and
Control substrate preheating temperature is temperature is not in the set restart analyzing unit and the
out of range. range after incubation. computer. If three continuous

Operator's Manual
code Class
A60007 Temperature Error Reaction carousel temperature / 1.The ambient temperature 1. Check if the error is
Control sensor short circuited is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
exists.
A60008 Temperature Error Dispersion carousel temperature / 1.The ambient temperature 1. Check if the error is
Control sensor short circuited is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
exists.
A60009 Temperature Error Substrate temperature sensor short / 1.The ambient temperature 1. Check if the error is
Control circuited is out of range. 2. The accidental.
temperature sensor goes 2. If the error is not accidental,
wrong. (component error, contact our customer service
cable error) 3. The department or your local

Operator's Manual
code Class
temperature protection distributor.
switch goes wrong.
exists.
A60010 Temperature Error Reaction carousel temperature / 1.The ambient temperature 1. Check if the error is
Control sensor disconnected is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
exists.
A60011 Temperature Error Dispersion carousel temperature / 1.The ambient temperature 1. Check if the error is
Control sensor disconnected is out of range. 2. The accidental.
temperature sensor goes 2. If the error is not accidental,
wrong. (component error, contact our customer service
cable error) 3. The department or your local
temperature protection distributor.
switch goes wrong.

Operator's Manual
code Class
exists.
A60012 Temperature Error Substrate temperature sensor / 1.The ambient temperature 1. Check if the error is
Control disconnected is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
exists.
A60013 Temperature Error Dispersion carousel temperature is / 1.The ambient temperature 1. Check if the error is
switch goes wrong.
exists.

Operator's Manual
code Class
A60014 Temperature Error Substrate preheating temperature is / 1.The ambient temperature 1. Check if the error is
switch goes wrong.
exists.
A60015 Temperature Error Reaction carousel temperature is / 1.The ambient temperature 1. Check if the error is
Control out of range.TDISP temperature: is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
exists.

Operator's Manual
code Class
A61001 Reagent Warning Reagent refrigeration temperature / 1.The ambient temperature 1. Check if the error is
refrigeration is out of range. TrDISP;%s is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
error) 4.The radiator goes
cable error) 5. The fan goes
cable error) 6. The
circulating pump goes wrong.
error) 7. The refrigerant
goes wrong. 8. PCB error
exists.
A61002 Reagent Warning Refrigerator fans are abnormal / 1. The fan is blocked. 1. Check if the error is
refrigeration 2. The fan is damaged. accidental. 2. If the error is not
3. The power supply goes accidental, contact our customer
wrong. service department or your local
distributor.
A61003 Reagent Warning Reagent refrigerating fan 1 is / 1. The fan is blocked. 1. Check if the error is
refrigeration abnormal. 2. The fan is damaged. accidental. 2. If the error is not
distributor.
A61004 Reagent Warning Reagent refrigerating fan 2 is / 1. The fan is blocked. 1. Check if the error is

Operator's Manual
code Class
distributor.
A61005 Reagent Warning Internal temperature of the whole / 1.The ambient temperature 1. Check if the air vent is
refrigeration unit is out of is out of range. 2.The blocked. Clean the dust screen if
range\r\nTemperature: %s cooling fan goes wrong. it is blocked. 2. Check if enough
3.The dust screen is blocked. space is reserved between the air
4.The air vent is blocked in vent and the wall. If not,
the specified range. reallocate the instrument. 3.
Check if the error is accidental.
distributor.
A61006 Reagent Warning Cooling fan of whole unit is / 1. The fan is blocked. 1. Check if the error is
distributor.
refrigeration sensor short circuited is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
cable error) 6. The

Operator's Manual
code Class
goes wrong. 8. PCB error 9.
Parameters are lost. 10.
exists.
refrigeration sensor disconnected is out of range. 2. The accidental. 2. If the error is not
switch goes wrong.
cable error) 6. The
goes wrong. 8. PCB error 9.
Parameters are lost. 10.
exists.
A61010 Reagent Warning Internal temperature sensor of the / 1.The ambient temperature 1. Check if the air vent is
refrigeration whole unit is short circuited is out of range. 2.The blocked. Clean the dust screen if
cooling fan goes wrong. it is blocked. 2. Check if enough

Operator's Manual
code Class
distributor.
A61011 Reagent Warning Internal temperature sensor of the / 1.The ambient temperature 1. Check if the air vent is
refrigeration whole unit is disconnected. is out of range. 2.The blocked. Clean the dust screen if
cooling fan goes wrong. it is blocked. 2. Check if enough
distributor.
C00007 Operating system Error CPU performance low / The CPU is too busy. Reboot the computer and
operating software. If this
distributor.
C00008 Operating system Warning Printer cannot be connected / The printer is not powered Check printer connection; Check
on; the printer cable is not if printer is powered on, driver
connected; or no driver is and default printer has been
installed. installed
C00012 Operating system Warning Sound card failure / No sound card is installed; Reinstall sound card or sound
Sound card failure; Incorrect card driver
sound card driver

Operator's Manual
code Class
C01001 System Error Equipment cannot be connected / The network cable is not Check the network cable
communication connected; or the analyzing connection. Replug the cable.
unit power is switched off. Check if the analyzing unit is
powered on. Start the
initialization again. Restart the
computer and analyzing unit. If
three continuous attempts are
failed, contact our customer
distributor.
C02005 Database Warning Reading/Writing database failed / The database does not work Reboot the computer and
normally. analyzing unit. If three
continuous attempts are failed,
contact our Customer Service
Department or your local
distributor.
C03008 Algorithm Warning Sample concentration is higher than / Sample concentration is No actions are required.
that of the highest-level calibrator higher than that of the
highest-level calibrator
C03018 Algorithm Warning Chemistry: 1-2S The QC result is between ±2 No actions are required.
Control: 1-2S warning and ±3 standard deviations
concentration.
C03019 Algorithm Warning Chemistry: 1-3S The current QC result is Check if the reagent is qualified
Control: 1-3S out of control greater than ± 3 standard and control is normal. If the error
deviations from the assigned remains, contact our customer
mean concentration. service department or your local
distributor.
C03020 Algorithm Warning Chemistry: 2-2S Results of two controls in the Check if the reagent is qualified
Control: 2-2S out of control same run or two continuous and control is normal. If the error
results of a control are on the remains, contact our customer
same side and greater than service department or your local

Operator's Manual
code Class
±2 standard deviations from distributor.
the assigned mean
concentration.
C03021 Algorithm Warning Chemistry: R-4S One result of a run is greater Check if the reagent is qualified
Control: R-4S out of control than +2 standard deviations and control is normal. If the error
from the assigned mean and remains, contact our customer
the other greater than -2SDs. service department or your local
distributor.
C03022 Algorithm Warning Chemistry: 4-1S Results of two runs (4 Check if the reagent is qualified
Control: 4-1S out of control results), or 4 continuous and control is normal. If the error
same side and greater than service department or your local
±1 standard deviation from distributor.
the assigned mean
concentration.
C03023 Algorithm Warning Chemistry: 10-X Results of five runs (10 Check if the reagent is qualified
Control: 10-X out of control results), or 10 continuous and control is normal. If the error
same side. service department or your local
distributor.
C04001 Rack feeder Warning Duplicate sample bar code. Sample / Duplicate bar code is used. Replace the duplicate sample bar
system ID/bar code: %s\r\nPosition code label.
1: %s\r\nPosition 2: %s
C04006 Rack feeder Warning Sample is expired Sample ID/bar / The sample is loaded after its The sample is expired. Replace
system code: %s/%s; position: %s shelf life is exceeded. the sample and program it again.
Reject the expired sample. If the
sample shelf life is too short,
change it to a reasonable one.
C04008 Rack feeder Warning Sample bar code too long. / The bar code length is Redefine the bar code with no
system Position: %s greater than the maximum more than 27 digits.
value of 27 digits.

Operator's Manual
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C04009 Rack feeder Warning Sample bar code is less than 3 / The bar code length is less Redefine the bar code with no
system digits. Position: %s than the minimum value of 3 less than 3 digits.
digits.
C05002 Reagent bar code Warning Reagent bar code / Incorrect reagent bar code is Replace reagent bottle, or
compositions error\r\nPosition :%s being used, or reagent bar contact reagent supplier to
code is not configured replace.
reasonably. The reagent bar
code contains incomplete or
incorrect reagent
information, such as wrong
bottle specification.
C05003 Reagent bar code Warning Reagent bar code analysis / Incorrect reagent bar code is Check the reagent bar code
compositions error\r\nPosition :%s being used, or reagent bar settings, or reprint the reagent
code settings are incorrect. bar code against the settings. In
Non-closed reagent bar code the case of a closed-reagent
is being used in a system, contact the reagent
closed-reagent system. The supplier.
system fails to extract
reagent information from the
bar code.
C06001 LIS Error LIS initialization error / Host file is damaged or does Reinstall the operating software.
not exist.
C06002 LIS Error LIS communication parameter error / Host parameters error Re-set or modify the host
communication parameters.
C06003 LIS Error LIS communication error / Communication failure If the error occurs accidentally,
neglect the error and send or
receive the instruction again. If
the error occurs for several
times, contact LIS vendor. If the
problem remains, contact our

Operator's Manual
code Class
C06004 LIS Error LIS host cannot be connected / Abnormal network Check if LIS host and LIS station is
connection, or the LIS host is started normally.
not started.
C06005 LIS Warning Sending sample results failed. / Communication failure If the error occurs accidentally,
Sample ID/bar code: %s, position: %s neglect the error and send or
C06006 LIS Warning Sending sample information failed. / Communication failure If the error occurs accidentally,
Sample ID/bar code: %s, position: %s neglect the error and send or
C06007 LIS Warning Inquiring sample information failed. / LIS host failure. Neglect the error if occurs
Sample ID/bar code: %s, position: %s contingently. If the error occurs
frequently, contact the
manufacturer of LIS Neglect the
error. If the error occurs
frequently, contact the
manufacturer of LIS or contact
C06008 LIS Warning Downloading sample failed. Sample / Incorrect channel settings; or Check and re-set the chemistry
ID/bar code: %s; position: %s insufficient or redundant correspondence between the
chemistries on the LIS host. operating software and the LIS
host.

Operator's Manual
code Class
C06011 LIS Warning Downloading sample failed. Sample / The sample ID has existed on Reset the sample ID and ensure it
ID/bar code: %s; position: %s operating software and does not conflict with existing
cannot be downloaded from ones.
LIS.
C07023 Consumable Warning Chemistry: %s\r\n 30 minutes left / The calibration factors are Recalibrate the chemistries.
for next calibration. about to be expired.
C07027 Consumable Warning Calibrator %s Lot no.%s has been / Calibrator is expired. Replace the calibrator.
expired.
C07028 Consumable Warning Chemistry:%s, lot number:%s, RGTE Expired reagent Replace the reagent.
position:%s, has been expired
C07029 Consumable Warning Chemistry:%s, lot number:%s, RGTE The uncapping time of the Replace the reagent.
position:%s, has exceeded the reagent pack is too long.
on-board stability time.
C07036 Consumable Warning Chemistry: %s. Calibration factors / The calibration factors are The calibration factors are
are expired expired. expired.
C07038 Consumable Warning Reagent lot number of %s chemistry / Lot number of the reagent is Recalibrate the chemistry.
is changed. Please recalibrate changed.
C07039 Consumable Warning Calibration factors of %s chemistry / The calibration factors are The calibration factors are
are expired. Recalibrate expired. Recalibration is expired. Recalibration is
required. required.
C07043 Probe unit Error Opening reagent carousel cover is / 1.The reagent carousel is not Make sure the reagent carousel
not permitted in current status and allowed to be opened during cover is closed. Start the
will stop the system. test. initialization again or restore the
2. The sensor for detecting system. If this message appears
the open/close of the reagent for 3 times, contact our customer
carousel cover goes wrong. service department or your local
distributor.
C07102 Consumable Warning %s less than %d%% / All inventory of the sample Refill or replace the sample
diluent is less than the diluent.
minimum limit. Or sample

Operator's Manual
code Class
diluent is too little to be
detected.
C07103 Consumable Sample Diluent is exhausted / All inventory of the sample Refill or replace the sample
diluent is less than the diluent.
minimum limit. Or sample
diluent is too little to be
detected.
C07104 Consumable Reagent volume is insufficient. / All inventory of the reagent Refill or replace the reagent.
is less than the minimum
limit. Or reagent is too
little to be detected.
C07105 Consumable Error Substrate 1 is exhausted. / Substrate 1 is exhausted. Replace substrate at
corresponding positions
C07106 Consumable Error Substrate 2 is exhausted. / Substrate 2 is exhausted. Replace substrate at
C07107 Consumable Error Less than %s tests are left in / Reagents left in substrate are Refill substrate
substrate. less than the minimum limit.
C07108 Consumable Error Substrate is exhausted. / All substrate is exhausted. Replace substrate at
C07109 Consumable Warning Substrate 1 is expired. SUBE Substrate is expired. Replace substrate at
C07110 Consumable Warning Substrate 2 is expired. SUBE Substrate is expired. Replace substrate at
C07115 Consumable Warning Remaining space of solid waste / The number of cuvette waste Replace waste container
container is less than %s cuvettes. in the solid waste container is
less than the alarm limit.
C07119 Consumable Reagent is exhausted. / All inventory of the reagent Refill or replace the reagent.
is less than the minimum
limit. Or reagent is too

Operator's Manual
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little to be detected.
C07120 Consumable Warning %s has been expired; position:%s RGTE Diluted reagent is exhausted. Replace diluent at corresponding
position
C07121 Consumable Error During test, no waste container is / The waste container is taken Load the waste container.
available because it is taken away. away.
C07125 Consumable Warning %s used up, reagent position:%s / The volume of the diluent has Refill or replace the sample
not reached the set lowest diluent.
limit; or the level of the
reagent cannot be detected.
C07126 Consumable Warning Probe wash solution is insufficient. / The inventory of probe wash Refill or replace the probe wash
solution is below the alarm solution
limit.
C07127 Consumable Warning Probe wash solution is exhausted. / Probe wash solution is Refill or replace the probe wash
exhausted. or no liquid level solution
is detected.
C07128 Consumable Warning Probe wash solution is expired. / Probe wash solution is Replace the probe wash solution.
expired.
C07129 Consumable Warning The remaining reaction cuvettes are / The cuvette inventory is less Load new cuvette tray
less than %s. than the alarm limit.
C07130 Consumable Warning Reaction cuvettes are exhausted. / Cuvettes are exhausted. Load new cuvette tray
C07131 Consumable Warning Substrate has exceeded the SUBE Substrate is expired. Replace substrate at
uncapping time. corresponding positions
C07132 Consumable Warning Substrate 2 has exceeded the SUBE Substrate is expired. Replace substrate at
on-board stability time. corresponding positions
C07133 Consumable Substrate volume is too little or / Substrate volume is too little Load the substrate.
substrate is unloaded. or substrate is unloaded.
C07134 Consumable Error Phase%s dispersion aspirate probe is / Dispersion Aspirating probes Unclog or replace the dispersion
clogged. Please unclog or replace it. are clogged. aspirate probe and perform daily

Operator's Manual
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clean procedure.
C07137 Consumable The capacity of the waste container / The capacity of the waste Empty the waste container or
is insufficient or the waste container is insufficient or load the waste container.
container is unloaded. the waste container is
unloaded.
C07141 Consumable Warning The solid waste container is full. / The solid waste container is Emptying Waste Container
Please empty it. full.
C07142 Consumable Warning Calibration request failed due to / The calibrator position is Release the occupied position for
duplicate positions. occupied by other sample. the calibrator.
C07143 Rack feeder Warning Duplicate calibrator position / Duplicate calibrator position Remove the chemistry of
system detected in the requested detected in the requested duplicate calibrator position or
calibration. calibration. set other position for the
Position:%s,chemistry:%s calibrator.
C07144 Rack feeder Warning Chemistry:%s. Calibration request / Calibration position is Cancel calibration request or
system failed due to duplicate positions. duplicate. request calibration after the
Position:%s,operation:%s, calibration position is released.
chemistry:%s
C07145 Rack feeder Warning Chemistry:%s. Calibration request / The position for the Release the position manually.
system failed due to duplicate position. calibrator is not released.
Position:%s. Please release this
position first.
C08001 Rack feeder Error Unidentifiable rack / The bar code length is Redefine the bar code with no
system bar code greater than the maximum more than 27 digits.
value of 27 digits.
C08003 Rack feeder Error Extra samples detected on the rack, / 1. Samples have been loaded 1. Check if the sample is
system sample position:%s but not programmed or correctly placed.
analyzed. 2. Restore the system and rerun
2. Sensor detection error. the test.
2. If the error occurs repeatedly,

Operator's Manual
code Class
distributor.
C08005 Rack feeder Error Rack bar code already exists. / Replicate sample rack bar Use the rack with different rack
system Duplicate Barcode:%s codes are used. bar code.
C08008 Rack feeder Warning Another rack is placed into lane %s. / 1.Another rack is placed into 1. Please take out the rack which
system Please take it away. the lane. is most recently placed into the
2.The sensor for detecting lane. 2.Restore the system. 3. If
sample rack goes wrong. the error occurs repeatedly,
distributor.
C08009 Rack feeder Warning Rack in lane%s is taken away / 1. Sample rack is taken away 1. If the operation matches with
system abnormally. abnormally. the alarm, handle the samples
2.The sensor for detecting according to the test
sample rack goes wrong. requirement.
2. If the alarm does not match
with the operation and occurs
repeatedly, contact our customer
distributor.
C08010 Rack feeder Warning Calibrator %s is not placed in the / The calibrator is not correctly Please request calibration after
system assigned position. Position %s is placed . the rack is taken away.
released. Please request calibration
again.
C08011 Rack feeder Warning Control %s is not placed in the / The control is not correctly Please request QC after the rack
system assigned position. Position %s is placed . is taken away.
released. When requesting QC,
enter QC program screen to reassign
the position.
C08012 Rack feeder Warning Sample %s is not placed in the / The sample is not correctly Please request sample test after
system assigned position. Position %s is placed . the rack is taken away.

Operator's Manual
code Class
released. Please enter Sample
list-Assign screen to reassigned
position for the sample.
C08013 Rack feeder Warning Sample %s is not placed in the / Sample is not placed in the Place the sample on the rack and
system assigned position. Position %s is assigned position. put the rack in the lane. Assign
released. position for the sample on the
start condition window.
C08014 Rack feeder Warning Sample with bar code %s is not / Sample is not placed in the After removing the rack, program
system placed in the assigned position. assigned position. the sample again or assign the
Position %s is released. position for the sample on the
assign window.
C09001 Analyzer Error Effect check / 1. The substrate volume is Check substrate volume and
Performance failed,CPS1:%s,CPS2:%s,CPS3:%s. insufficient or the cuvette cuvette volume. If they are
volume is insufficient. insufficient, load them. Then
2. Substrate goes bad. restore the system and perform
Effect Check. If this problem
C09002 Analyzer Warning Daily clean failed. / 1. Probe wash solution is not Check probe wash solution and
Performance loaded or insufficient. wash buffer. If they are
2. Wash buffer is exhausted insufficient, load them. Then
during Daily Clean process. restore the system and perform
Daily Clean. If this problem
C09003 Analyzer Error Auto effect check is not enabled. / The auto effect check is not handle according to the alarm
Performance performed because the prompt.
conditions are not satisfied.
C09004 Analyzer Error DCF is violently fluctuating. / Photometer is aged. Contact our customer service

Operator's Manual
code Class
Performance distributor.
C09005 Analyzer Error Auto Daily clean is not enabled. / The auto daily clean is not handle according to the alarm
Performance performed because the prompt.
conditions are not satisfied.
C09006 Analyzer Warning Wash solution is insufficient or / Wash solution is insufficient Fill the wash solution.
Performance unloaded. Wash buffer is used to or unloaded.
perform Daily Clean.
C09007 Analyzer Warning Consumables are not sufficient. / The required consumable is Add the consumable.
Performance Sampling will be stopped. insufficient.
Consumable:
C09008 Maintenance Warning Substrate coupler calibration is not / 1.Substrate 1 and 2 are used 1.Check if the substrate 1 and 2
enabled: :%S up. are used up.
2.Substrate optical coupler or 2.Check the wire connection.
its wire goes wrong. 3.If the substrate pump or
3.Substrate pump goes substrate optical coupler goes
wrong. wrong, contact our customer
distributor.
C09009 Maintenance Warning Substrate prime cannot be / 1.Substrate 1 and 2 are used 1.Check if the substrate 1 and 2
started: %S up. are used up.
2.Substrate optical coupler or 2.Check the wire connection.
its wire goes wrong. 3.If the substrate pump or
3.Substrate pump goes substrate optical coupler goes
wrong. wrong, contact our customer
distributor.
C10001 Consumable Warning The analysis is not permitted / The shielding cover is opened Close the shielding cover.
because the shielding cover is during operation.
opened during operation.

Operator's Manual

Operator's Manual
17 Template Modifying Software
The Template Modifying Software is affiliated with the Operating Software and used to
create or edit print templates, which illustrate the contents and format of patient reports.
The Template Modifying Software can be started separately or together with the
Operating Software. To start the Template Modifying Software, select the Edit button on
the Print page of the operating software.
The following sections introduce the Template Modifying Software by menus and
toolbars.

Operator's Manual
17.1 Main Screen
17.1 Main Screen

17.1.1 Main Screen
The following figure shows the main screen of the Template Modifying Software.
Figure 17.1 Main screen
17.1.2 File (F)

The File menu is used to create, save, import/export and print out the templates. Select
File on upper-left corner of the main screen. The File menu is displayed.
The following table explains the menu in detail.
Option Description
New Select New to create a template. The type of the template is
determined by the report that is currently selected on the report
window.
You can also use the shortcut key Ctrl+N instead.
After changing the currently-displayed template, select New to
display the following dialog box.

Operator's Manual
17.1 Main Screen
Option Description
 Select Yes to save the changes and create a template.

 Select No to cancel the changes and create a template.
 Select Cancel to abort creating and return to the previous
screen.
Save Select Save to save the newly-created template or the changes to a
template.
You can also use the shortcut key Ctrl+S instead.
To save a new template, you should define the template name:
 Enter the name in the edit box.

 Select OK to save the template and add the name to the
template list on the report window.
 Select Cancel to abort saving and return to the previous screen.
If a template with the same name already exists, the following
dialog box pops up.
 Select Yes to overwrite the template.

 Select No to cancel saving and return to the previous screen.
Save As Save the current template with another name.

Operator's Manual
17.1 Main Screen
Option Description
If a template with the same name already exists, a dialog box
appears to ask for your confirmation.
Preview Select this option to view the template exactly as it will be printed
out.
The main screen will be hidden when you preview a template.
The tool bar on the Preview window is as follows.
 If the template has more than one page, and are

available.
 : Go to the first page.

 : Go to the previous page.
 : Go to the specified page.

 : Go to the next page.
 : Go to the last page.
 : Select to expand the template view among 25%, 50%, 75%

and 100%. The default is 100%.
 : Select to shrink the template view.
 : Print out the template. It is equivalent to the Print option in

the File menu.
 : Select to exit the preview window and return to the

template.
Exit Select this option to close the Template Modifying Software.
You can use the shortcut key Alt+F4 instead.
If the template is changed, the following dialog box pops up.
 Select Yes to save the changes and exit the software.

 Select No to exit the software without saving the changes.
 Select Cancel to abort exiting and return to the previous screen.

Operator's Manual
17.1 Main Screen
17.1.3 Edit (E)

The Edit menu provides the functions like cut, copy, paste and delete. Select Edit on the
menu bar of the main screen. The Edit menu is displayed.
NOTE
The control(s) you have cut or copied can only be pasted on the current Template
Modifying Software rather than another one or other software.
Option Description
Cut Select this option to copy and delete single or multiple controls.
You can use the shortcut key Ctrl+X instead.
This option is available only when a control(s) is selected.
Copy Select this option to copy single or multiple controls.
You can use the shortcut key Ctrl+C instead.
Paste Select this option to paste the controls that are previously cut or
copied at the same place as where the controls are from.
You can use the shortcut key Ctrl+P instead.
This option is available only when a control(s) is cut or copied.
Delete Select this option to delete single or multiple controls
You can use the shortcut key Ctrl+D instead.
17.1.4 View (V)

The View menu is used to enable or disable the toolbars and to set up the displaying
proportion. Select View on the menu bar of the main screen. The View menu is displayed.

Operator's Manual
17.1 Main Screen
Option Description
Common Enable or disable the common toolbar.
Tool
Draw Tool Enable or disable the draw toolbar.
Property Enable or disable the property window.
Window
Report Enable or disable the report window.
Window
Status Bar Enable or disable the status bar.
25%-200% Select a proportion to display the template. The default is 100%.
NOTE
You are recommended to select 100% when saving a template.
17.1.5 Insert (I)

The Insert menu is used to create controls in the editing page. Select Insert on the menu
bar of the main screen. The Insert menu is displayed.
Only one option on the Insert menu can be selected simultaneously.
Option Description
Select
Select this option to change the mouse pointer to a .
When the mouse pointer changes to a , you can select single or

multiple controls in the editing area.
NOTE
Selecting a control while holding the Ctrl key copies the control.
Line Select this option to insert a line in the editing area. The mouse
pointer changes into a +. Click once in the editing area and drag
the mouse to draw a line.
Rectangle Select this option to insert a rectangle in the editing area. The
mouse pointer changes into a +. Click once in the editing area and
drag the mouse to draw a rectangle.

Operator's Manual
17.1 Main Screen
Option Description
Label Select this option to insert a label in the editing area. The mouse
the mouse to draw a label.
Label is a type of text control and the contents on a label will not
change when printed.
Text Select this option to insert a text control in the editing area. The
mouse pointer changes into a +. Click once in the editing area and
drag the mouse to create a text.
The contents in a text control will be replaced by the actual test
data when printed.
Title Select this option to insert a title in the editing area. The mouse
the mouse to create a title.
Title is a type of text control. The “%s” will be replaced by a
hospital name when printed. Please note “%s” is added by user and
not produced automatically.
Image Select this option to insert an image in the editing area. The mouse
the mouse to create an image.
The image on the template is for illustration only and will be
replaced by corresponding curve graph when printed.
17.1.6 Format (M)

The Format menu is used to arrange the controls on a template. Select Format on the
menu bar of the main screen. The Format menu is displayed.
Option Description
Left Align the specified controls with the left of the lastly-selected
control.
Right Align the specified controls with the right of the lastly-selected
control.
Top Align the specified controls with the top side of the
lastly-selected control.

Operator's Manual
17.1 Main Screen
Option Description
Bottom Align the specified controls with the bottom side of the
Center H Align one or multiple controls to the horizontal center of current
template.
Center V Align one or multiple controls to the vertical center of current
template.
Even Space Arrange three or more controls with same space horizontally.
H
Even Space Arrange three or more controls with same space vertically.
V
Same Width Adjust the specified controls to the same width as the
Same Height Adjust the specified controls to the same height as the
Same Size Adjust the specified controls to the same width and height as the
17.1.7 Set(S)
The Set menu only includes an option, Print ID. See the figure below.
Select Print ID. The Set Print ID dialog box is displayed. You can enable or disable the
print fields and view the corresponding ID of each field.

Operator's Manual
17.1 Main Screen
17.1.8 Help (H)

Select Help on the menu bar of the main screen. The Help menu is displayed.
Option Description
About Select this option to view the version information of the
MakePrintTemplate template modifying software.

Operator's Manual
17.2 Common Tools
17.2 Common Tools

The common toolbar provides the shortcut buttons that enables you to perform an
operation quickly.
The following table shows the correspondence between the shortcut buttons and menu
options.
Button Menu Option
New File/New
Save File/Save (not enabled)
Save As File/Save As
Import File/Import
Export File/Export
Delete File/Delete
Print File/Print
Preview File/Preview
Cut Edit/Cut
Copy Edit/Copy
Paste Edit/Paste
Delete Edit/Delete
Zoom View/25%-200%
Property View/Property Window
Rpt List View/Report Window
Print ID Set/Print ID

Operator's Manual
17.3 Draw Tools
17.3 Draw Tools

The draw toolbar provides the shortcut buttons that enables you to create and draw
controls quickly.
The following table shows the correspondence between the shortcut buttons and menu
options.
Button Menu Option

Insert/Select
Insert/Line
Insert/Rectangle
Insert/Label
Insert/Text
Insert/Title
Insert/Image
Format/Left
Format/Right
Format/Top
Format/Bottom
Format/Center H
Format/Center V
Format/Even Space H
Format/Even Space V
Format/Same Width

Operator's Manual
17.3 Draw Tools
Button Menu Option

Format/Same Height
Format/Same Size

Operator's Manual
17.4 Property Window

The property window enables you to view and edit the properties of the selected control.
If no control is selected in the window, the properties of the current template are
displayed.
17.4.1 Page
When no control is selected, the property window shows the properties of the current
template, such as paper, print type, etc.
The following table explains the template properties in detail.
Paper Define the paper type of the template. There are 9 common types
available.
If the paper width and height you defined are beyond the specified
range, Custom is displayed in the Paper field.
Paper Width Define the width of the template.
Paper Define the height of the template.
Height
Grid Point Enable or disable grid points on the template.
Print Type Includes Paginal and Serial.
Combination Whether to print two reports on one piece of paper. Merging reports
Type is now not permitted.
17.4.2 Line
When a line control is selected, the property window shows the properties of the line.

Operator's Manual
The following table explains the line properties in detail.

ID Print ID of the line. The ID is 2.
Start X Set the X-coordinate value of the start point.
NOTE
The control coordinate originates from the upper-left corner of
the editing area, from which the X axis (positive) is extended
horizontally to the right and the Y axis (positive) vertically to the
bottom. The unit is mm.
Start Y Set the Y-coordinate value of the start point.

End X Set the X-coordinate value of the end point.
End Y Set the Y-coordinate value of the end point.
Line Width Set the width of the line. The unit is mm.
Group No. A group gathers multiple controls that will be used frequently on
the template. e.g. a line of controls constitutes a group. The
group No. is 0 if not defined.
Line Color Set the color of the line.
Print Enable or disable printing the line on actual reports.
17.4.3 Rectangle
When a rectangle control is selected, the property window shows the properties of the
rectangle.

Operator's Manual
The following table explains the rectangle properties in detail.
ID Print ID of the line. The ID is 1.
Start X Set the X-coordinate value of the start point (upper-left corner).
Start Y Set the Y-coordinate value of the start point (upper-left corner).
Width Set the width of the rectangle.
Height Set the height of the rectangle.
Frame Width Set the frame width of the rectangle.
Frame Color Set the color of the frame.
Print Enable or disable printing the rectangle on actual reports.
17.4.4 Label
When a label control is selected, the property window shows the properties of the label.

Operator's Manual
The following table explains the label properties in detail.
ID Print ID of the label. The ID is 4.
Text Set the text on the label. It will be printed unchanged on actual
reports.
Width Set the width of the label.
Height Set the height of the label.
Bk Color Set the background color of the label.
Font Set the font of the label text.
Text Place Set the aligning mode of label text. It includes Left, Center and
Right.
Show Frame Enable and disable printing frame.
Frame Width Set the width of the label frame.
Frame Color Set the color of the label frame.
Print Enable or disable printing the label on actual reports.
Text ID The ID of the label text represented by number. When it is

edited, the template is refreshed.

Operator's Manual
Replace text Choose whether to use the defined text ID to replace the text of
the control.
17.4.5 Text
When a text control is selected, the property window shows the properties of the text.
The following table explains the text properties in detail.

ID Print ID of the text. The default is 0 and means unknown ID.
Print ID indicates the meaning of the text. Correct printout can
be ensured only when print ID is set properly.
Name Set the contents to be displayed on the text control. It varies
from different IDs.
Text Set the contents displayed on the text control. It will be
replaced by actual data when printed.
Show Detail Set the text as table data.
NOTE
Only the text that not only is enabled in Show Details field but
also has a group No. is table data.
Width Set the width of the text.

Operator's Manual
Height Set the height of the text.
Text Type Reserved parameter. The default is 0.
Bk Color Set the background color of the text.
Font Set the font of the text.
Text Place Set the aligning mode of the text. It includes Left, Center and
Right.
Frame Width Set the width of the text frame.
Frame Color Set the color of the label frame.
Print Enable or disable printing the text on actual reports.
17.4.6 Title
When a title control is selected, the property window shows the properties of the title.
The following table explains the title properties in detail.
ID Print ID of the title. The ID is 5.
Text Set the contents to be displayed on the title. “%s“ will be
replaced by a hospital name and can be displayed in any
place of the title.

Operator's Manual
Start X Set the X-coordinate value of the start point (upper-left
corner).
Width Set the width of the title.
Height Set the height of the title.
Bk Color Set the background color of the title.
Font Set the font of the title text.
Text Place Set the aligning mode of title text. It includes Left, Center
and Right.
Frame Width Set the width of the title frame.
Frame Color Set the color of the title frame.
Print Enable or disable printing the title on actual reports.
Text ID The ID of the label text represented by number. When it is

edited, the template is refreshed.
Replace text Choose whether to use the defined text ID to replace the
text of the control.
17.4.7 Image
When an image control is selected, the property window shows the properties of the
image.
The following table explains the image properties in detail.

ID Print ID of the image. The ID is 3.
Start X Set the X-coordinate value of the start point (upper-left
corner).
Width Set the width of the image.

Operator's Manual
Height Set the height of the image.
Group No. A group gathers multiple controls that will be used

frequently on the template. e.g. a line of controls
constitutes a group. The group No. is 0 if not defined.
Print Enable or disable printing the image on actual reports.

Operator's Manual
17.5 Report Window
17.5 Report Window

The report window locates on the lower-right corner of the main screen and shows all
the templates of a selected report type.

Operator's Manual
17.5 Report Window

Operator's Manual
Vocabulary
Analyzer
The analyzer, determines various clinical chemistries in samples and displays the test
results. is composed of sample handling system, reagent handling system, sampling
system, substrate system, optical measurement reaction system, dispersion system,
cuvette load and transportation system, reaction liquid mixing system and sample
delivery module.
Auto rerun
When a result is beyond the defined range or satisfies the defined conditions, the
chemistry will be run again.
Bar code reader
Fixed scanner. It scans the bar code label on sample tubes to identify samples and match
the obtained programming information with the scanned samples.
Batch program
Batch program is to program a group of samples with identical programming information,
with the exception of the sample ID.
Calibration curve
A calibration curve reflects the mathematical relation between calibrator concentration
and response. It is drawn based on the obtained response and the multiple values
between the minimum and maximum concentrations of the calibrator.
Calibration trend
Calibration trend summarizes a chemistry’s calibrations during a period of time and
reflect the trends of the calibrations.
Carryover
Carryover is the interference of certain substance contained in a reagent. It can influence
measurement of another chemistry or the reaction of other mixture, resulting in
inaccurate results.
Chemistry configuration
Chemistry configuration is applicable to all chemistries and used to enable or disable
chemistries that have been defined correctly.
Closed-reagent chemistry
Closed-reagent chemistry is run by using the reagents provided by the analyzer
manufacturer. Closed-reagent chemistries cannot be modified or deleted.
Concentrated wash solution is used to clean the probe and used in daily clean.
CL-1000i Chemiluminescence Immunoassay Analyzer Vocabulary-1

Operator's Manual
Vocabulary
Critical range
An allowable result range from the perspective of clinical diagnosis. If the test result is
beyond the critical range, the patient may need immediate treatment. You may enable the
auto rerun function for a chemistry, which will be rerun automatically once the test result
is beyond the critical range.
Current results
Current results include those that are in Incomplete status until the current system time
and those programmed and analyzed on the current day.
Database
A collection of data arranged for quick search and retrieval.
Diluent
Liquid used to dilute other liquids.
Dilution factor
User-defined dilution ratio, to be multiplied with sample result to obtain the final result.
Download
To obtain sample programming information from the LIS host and match it with the
scanned samples. The system supports real-time and manual downloading of sample
programming information.
Dispersion System
The system supports 4-phase dispersion. When the incubation reaction of sample and
magnetic bead reagent is completed, it separates the sample-reagent analyte that has
been bound with beads from the liquid phase by wash buffer. The dispersion system is
composed of dispersion carousel and dispersion unit.
Flag
Flag is a manufacturer-defined symbol, which appears on patient reports or result list
when a result is beyond the user-defined reference range or exceeds the defined limits.
History results
Stored results are those programmed and analyzed before the current day.
Initialization
Initialization is a series of operations automatically performed by the system during the
startup procedure. It includes parameters check, reset, testing, cleaning and priming.
LIS
LIS stands for Laboratory Information System. It is a host computer and communicates
with the analyzer through the internet interface.
L-J chart
A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test results (Y), shows
the QC result trend of a chemistry during the specified period. The graphical trends of up
to 3 controls can be displayed on one L-J chart and distinguished with different colors.
Lot number
Lot number is assigned to controls, calibrators or wash solutions of the same lot for
identifying manufacture date, quality, expiration date and other related information.
Mask/Unmask chemistries
Vocabulary-2 CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
Vocabulary
Used when a chemistry needs to be disabled temporarily due to abnormal result or

reagent exhaustion. The masked chemistry will have a symbol appearing on its
upper-left corner, and will still be displayed on the Sample, Quality Control and
Reagent/Calibration screens but not run for sample analysis. Masked chemistries
cannot be requested until they are unmasked.
Multi-sample report
Containing the results of multiple samples, and can be printed out on the Current and
History screens.
Off-line dilution
Prior to analysis, samples are diluted manually based on specific ratio.
Offset
Offset is a value added or subtracted to compensate a result. It is often used along with
the slop in the equation y=kx+b, in which k is the slope and b is the offset.
Online help
Online help provides you with help information about the screens. If you do not
understand a parameter or an operation on a screen, you can go to the online help for
relevant information. Access the online help from the following screens:
 Select the icon on the upper right corner to display the help topic related to the
current screen.
 Select the button in front of each maintenance instruction or item to display the
relevant operating instructions.
 Select the icon in front of each diagnostic test to display the corresponding
topic.
 Select the button in front of each error log to display the corresponding topic.
 Click the button on a warning message window to display the corresponding

descriptions and solutions.
 Press the shortcut combination key Alt+F1 to display the topics related to the
current screen or window.
Operation unit
Operation unit is a computer installed with operating software to control the operation of
the analyzer and process the data.
Output unit
A printer used to print out test results and other data.
Panel
A couple of chemistries combined together for certain clinical purposes can constitute a
panel, such as: Two semi-hepatitis B and tumor. Panels can help fast programming of
samples.
Patient demographics
Patient demographics contain information related to the patient and sample, such as
patient name, age, gender, collection date/time, etc.
Photometer Module
The photometer module is composed of photon counting module and reference module.

Operator's Manual
Vocabulary
The photon counting module detects light intensity of the liquid to be measured, and
calculates the analyte concentration by calibration curve.
The reference module provides steady light output for the calibration of the photon
counting module, and evaluates counting stability and repeatability during photometer
diagnosis process.
Predilution
Prior to analysis, samples are diluted automatically based on the defined dilution factor.
Print name
Print name appears on a patient report representing a chemistry, and if left blank, will be
replaced by the short name of the chemistry.
Pull-down list
A control of the software screen or window. Select the down-triangle button on the right of
a pull-down list to show multiple options.
Probe
The probe aspirates the specified amount of sample and reagent and then dispenses it
into a cuvette for reaction and analysis. There is one probe, with up to 3 reagent
components can be added for one step method, 4 components for two step method.
Probe wash solution
Used to clean the probe and located in special wash position of the analyzer’s front panel.
QC panel
Used for analysis of control samples.
QC rule
A set of rules to evaluate if the QC results are under control and the analyzing system is
stable. Examples of QC rule are 1-2s, 1-3s, etc.
QC summary
Contains the mean values and standard deviations of controls analyzed within the
specified period, as well as the set mean and SD value. The obtained results are compared
with the set values to judge if the system is working normally.
Qualitative analysis
Qualitative analysis is used to analyze every sample for the detection of lipemia,
hemolysis and icterus and calculate the numeric values of the index. If the volume of the
interferents contained in a sample is beyond the set range, a flag will be added to the
patient report.
Rack feeder system
The Rack Feeder System is responsible for carrying samples to the aspirate position and
retrieving the racks when the aspiration is done. The Rack Feeder System mainly consists
of:
 Rack lanes
 Rack transfer assembly
 Barcode scanning lane
 Sample racks
Random error

Operator's Manual
Vocabulary
An alarm of quality control monitoring. A random error may occur when the lowest and
highest values of QC results respectively exceed -2SD/-3SD and +2SD/+3SD.
Reaction carousel
The reaction carousel is a turntable carousel located in the middle of the analyzer panel.
Reaction carousel is composed of 3 rings (inner, middle and outer), with each ring
holding 50 cuvettes, and 150 cuvette positions in total. The inner and middle rings are
used for sample and reagent incubation, and the outer ring is for reagent dispensing,
substrate incubation and optical measurement.
Reaction cuvette
Reaction cuvette is a carrier in which reagents and samples react with each other and
then carried to the photoelectric position for signal detecting and RLU calculation.
Reagent carousel
The reagent carousel is located on left side of the analyzer panel. It holds reagent bottles
and carries each of them to the reagent aspirate position for aspirating.
Reagent inventory alarm limit
Alarm limit of reagents and wash solutions. When the reagent inventory is lower than the
alarm limits during or before the analysis, the system will give an alarm and display the
reagent or wash solution name in yellow on the Reagent/Calibration screen.
Reagent load button
The reagent load button located on the lower-right corner of the reagent carousel is used
to rotate the reagent carousel. When the reagent load button is pressed and held, the
reagent carousel starts rotating continuously until the button is released.
Reference range
Reference range is a user-defined range consisting of low limit and high limit. When a
result is beyond the reference range, a flag will appear near the result.
Release
Positions on single rack, or multiple racks, or positions on all racks can be released
simultaneously. When a sample is released, its results and programming information can
be still recalled. and the released position can be used for programming of new samples.
Replicates
Number of times to run a test, to ensure accurate results.
Sample comments
Remarks for some special samples, such as, ** sample has hemolysis; ** sample needs to
be analyzed immediately, etc.
Sample type
Type of sample. The sample type options include serum, plasma, urine, amnio fluid and
other.
Screen
Screen is a part of the software interface. It is rectangular and contains various controls,
such as edit box, function button, etc.
Serial number
Sequence number of the reagent bottle.
Slope

Operator's Manual
Vocabulary
Multiplied with the test result to make it consistent with that obtained on other
instruments. It is often used along with the offset in the equation y=kx+b, in which k is
the slope and b is the offset.
Special calculation
Special calculation is derived from calculation of certain chemistries and has specific
clinical purposes, such as A/G, TBil-DBil, etc.
Standard deviation (SD)
Standard deviation is the mean of deviations from the mean value. It is an index to judge
the measurement accuracy under specific conditions. In this manual, SD refers to the
standard deviation of control concentration.
Standby
Standby is one of the system statuses. When the system status is Standby, it indicates that
all tests are finished and all actions of the system have stopped.
STAT
STAT means emergent, including common STAT and quick STAT program. STAT sample
program allows emergent samples to be programmed and analyzed with high priority.
Common STAT program is used in daytime to run emergent samples with higher priority
than routine samples. Quick STAT program is mainly used in nighttime and weekends to
program emergent samples quickly with higher priority than routine samples.
Substrate Status Button
Two substrate status buttons located on the panel in front of substrate bottles are
corresponding to bottles on the 2 working positions. After changing the substrate, press
corresponding button so that the system can automatically refresh substrate status.
Symbology
Symbology is a set of rules for encoding and decoding information contained in a bar code
label. The system provides a couple of symbologies, such as Codabar, ITF, code128, code39,
UPC/EAN, and Code93.
Systematic error
An alarm of quality control monitoring. A systematic error may occur when both the
lowest value and highest value of a QC result are on the same side.
Transmit
Transmit is an action sending specified sample results or QC results to the LIS host.

Operator's Manual
Vocabulary
Twin-Plot chart
A twin-plot chart, drawn based on the results of control X and control Y in the same run, is
used to detect systematic errors and random errors. It shows the recent 10 QC results of a
chemistry and excludes those that have been deleted.
Two-control evaluation
In two-control evaluation, two results are obtained: Xn and Yn, which are used to define a
point on the Twin-plot chart. In this way, a complete twin-plot chart is drawn based on all
the QC results and used for detecting systematic errors and random errors.
Unpositioned samples
Samples without positions assigned or with positions not assigned successfully, including
those:
 downloaded from the LIS host and not positioned yet.
 that are in Incomplete status when their positions are assigned for new samples.
 that are incomplete when their positions are released.
Westgard rule
Westgard rule is used for monitoring of quality control. In the Westgard rule, single rules
such as 12S, 13S, 22S and 41S are combined to evaluate results of single or multiple
controls.

Operator's Manual
Vocabulary

Operator's Manual
Index
ＢＰ
Background, 17-16, 17-18, 17-19
Power supply requirements, 1-2
Programming routine samples, 2-27
Ｃ
Calibration, 2-25 Ｑ
clearing samples, 8-12
Quality Control, 2-26
ＤＳ
Dialog Box, 5-9, 8-41 Sample probe, 1-12
Sample probe wash well, 1-12
Ｉ Special calculations, 10-2
Standby, 15-23
Installation requirements, 1-1 STAT, 2-30, 2-34
Status display area, 1-25
Ｌ System Setup, 3-2
LIS, 1-26, 2-9, 12-6, 13-5, 13-9

Ｔ
Ｍ Technical specifications, 1-1
Template Modifying Software, 17-4
Main Screen, 8-4 Twin-Plot chart, 3-5
CL-1000i Chemiluminescence Immunoassay Analyzer Index-1

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Index
Index-2 CL-1000i Chemiluminescence Immunoassay Analyzer

Operator's Manual
P/N:046-006994-00(3.0)

CL-1000i Operation Manual V3.0 en

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CL-1000i Operation Manual V3.0 en

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CL-1000i Chemiluminescence

CL-1000i Chemiluminescence Immunoassay Analyzer i

Intellectual Property Statement

ii CL-1000i Chemiluminescence Immunoassay Analyzer

Responsibility on the Manufacturer Party

CL-1000i Chemiluminescence Immunoassay Analyzer iii

Customer service department

iv CL-1000i Chemiluminescence Immunoassay Analyzer

CL-1000i Chemiluminescence Immunoassay Analyzer v

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-1

When you Text Then

Safety Information-2 CL-1000i Chemiluminescence Immunoassay Analyzer

Electric Shock Hazards

Moving Parts Hazards

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-3

Sample, Calibrator and Control Hazards

Reagent and Wash Solution Hazards

System Disposal Hazards

Fire and Explosion Hazards

Safety Information-4 CL-1000i Chemiluminescence Immunoassay Analyzer

Removal of Analyzer from Use for Repair or Disposal

Changing Waste Tank

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-5

Cleaning and Decontamination

Safety Information-6 CL-1000i Chemiluminescence Immunoassay Analyzer

Electromagnetic Noise Precautions

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-7

Safety Information-8 CL-1000i Chemiluminescence Immunoassay Analyzer

Maintenance and Servicing Precautions

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-9

Reagent, Calibrator and Control Precautions

Rack Feeder System Precautions

Data Archiving Precautions

Safety Information-10 CL-1000i Chemiluminescence Immunoassay Analyzer

External Equipment Precautions

Tube and Liquid Container Precautions

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-11

Instrument Labels and Silkscreen

Non-Warning Labels and Silkscreen

In vitro diagnostic equipment

European community representative

Safety Information-12 CL-1000i Chemiluminescence Immunoassay Analyzer

Power switch: Off

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-13

Load/Unload reagent bottle

Sample rack indicator

Interfaces for fluid connection

Safety Information-14 CL-1000i Chemiluminescence Immunoassay Analyzer

Moving Parts Warning

CL-1000i Chemiluminescence Immunoassay Analyzer Safety Information-15

Probe Collision Warning

Shielding Cover Warning

Safety Information-16 CL-1000i Chemiluminescence Immunoassay Analyzer

Intellectual Property Statement ............................................................................................................................................. ii

Safety Information ··································································································· 1

Safety Symbols .............................................................................................................................................................................. 2

CL-1000i Chemiluminescence Immunoassay Analyzer I

Data Archiving Precautions ....................................................................................................................................10

Table of Contents ····································································································· I

1 System Description ······························································································1-1

1.1 Installation Requirements and Procedure .............................................................................................................. 1-2

II CL-1000i Chemiluminescence Immunoassay Analyzer

1.5.4 Dimensions and Weight ........................................................................................................................... 1-41