Mindray BS-120 User manual

BS-120 Chemistry Analyzer
Operator’s Manual

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© 2007-2010 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights
Reserved.
For this Operator’s Manual, the issue date is 2010-04.
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.
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.

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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.
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.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
E-mail Address: [e-mail]
Tel: [phone] 26582888
Fax: [phone] 26582500
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: [phone]
Fax: [phone]

Foreword 1
Foreword
Before using the Chemistry Analyzer, please read this operation manual thoroughly
and understand it for best performance.
Please keep this manual properly for convenient use.
Who Should Read This Manual
This manual is geared for clinical professionals to:
Perform daily operating tasks;
Maintain and troubleshoot the system;
Learn about the hardware and software.
WARNING
The system is to be operated only by clinical professionals, doctors or
laboratory experimenters trained by our company or our authorized
distributors.
What Can You Find in This Manual
This manual covers principles, basic operating instructions, maintenance and
troubleshooting guidelines of the system. Please operate and troubleshoot the
system strictly as instructed by this manual.
Conventions Used in This Manual
Safety Symbols
This chart explains the symbols used in this manual.
When you see… Then…
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.

Foreword2
When you see… Then…
NOTE
Read the statement following the symbol. The
statement is alerting you to information that
requires your attention.
Labels Used On the System
The labels attached to the panels of the system use symbols to clarify the meaning
of the text. If any of the labels becomes vague or peels off, contact our customer
service department or your local distributor for replacement. The chart below
explains the symbols on the labels.
Serial Number
Date of Manufacture
Manufacturer
CE marking. The device is fully in conformity with the
Council Directive Concerning In Vitro Diagnostic
Medical Devices 98/79/EC.
Authorized Representative in the European Community
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.
In Vitro diagnostic equipment
Biohazard warning: Risk of potentially biohazardous
infection
Warning: Risk of personal injury or equipment damage
Warning: Risk of burn
ON (Main Power)
OFF (Main Power)
ON (Power)
OFF (Power)

Foreword 3
Serial communication port
Protective ground terminal
Graphics
All graphics, including screens and printout, are for illustration purposes only and
must not be used for any other purpose.
Special Terminology
In this operation manual, “Sample Probe” refers to the same object as the “Reagent
Probe” does. When introducing software operations, we call the probe “Sample
Probe” for sample aspiration/dispensing and “Reagent Probe” for reagent
aspiration/dispensing.
In this operation manual, “Sample/Reagent Disk” refers to the same object as the
“Sample Disk” and “Reagent Disk” does. When introducing software operations, we
call the disk “Sample Disk” for sample aspiration/dispensing and “Reagent Disk” for
reagent aspiration/dispensing.

Foreword4
Safety Precautions
Observe the following safety precautions when using the Chemistry Analyzer.
Ignoring any of these safety precautions may lead to personal injury or equipment
damage.
WARNING
If the system is used in a manner not specified by our company, the
protection provided by the system may be impaired.
Preventing Electric Shock
Please observe the following instructions to prevent electric shock.
WARNING
When the Main Power is on, you must not open the rear cover or side
cover.
Spillage of reagent or sample on the analyzer may cause equipment
failure and even electric shock. Do not place sample and reagent on
the analyzer. In case of spillage, switch off the power immediately,
remove the spillage and contact our customer service department or
your local distributor.
Preventing Personal Injury Caused by Moving Parts
Please observe the following instructions to prevent personal injury caused by
moving parts.
WARNING
Do not touch such moving parts as sample probe and mixer, when the
system is in operation.
Do not put your finger or hand into any open part when the system is
in operation.

Foreword 5
Preventing Personal Injury Caused by Photometer Lamp
Please observe the following instructions to prevent personal injury caused by
photometer lamp.
WARNING
Light sent by the photometer lamp may hurt your eyes. Do not stare
into the lamp when the system is in operation.
If you want to replace the photometer lamp, first switch off the Main
Power and then wait at least 15 minutes for the lamp to cool down
before touching it. Do not touch the lamp before it cools down, or you
may get burned.
Preventing Infection
Please observe the following instructions to protect against the biohazardous
infection.
BIOHAZARD
Inappropriately handling samples, controls and calibrators may lead to
biohazardous infection. Do not touch the sample, mixture or waste
with your hands. Wear gloves and lab coat and, if necessary, goggles.
In case your skin contacts the sample, control or calibrator, follow
standard laboratory safety procedure and consult a doctor.
Handling Reagents and Wash Solution
Please observe the following instructions to protect against the chemical hazard.
WARNING
Reagents and wash solution may hurt human skins. Exercise caution
when using the reagents and wash solution. In case your skin or
clothes contact them, wash them off with soap and clean water. In
case the reagents or wash solution spill into your eyes, rinse them
with much water and consult an oculist.

Foreword
6
Treating Waste Liquids
Please observe the following instructions to prevent environmental pollution and
personal injury caused by waste.
BIOHAZARD
Some substances in reagent, control, wash solution and waste are
subject to regulations of contamination and disposal. Dispose of them
in accordance with your local or national guidelines for biohazard
waste disposal and consult the manufacturer or distributor of the
reagents for details.
Wear gloves and lab coat and, if necessary, goggles.
Treating Waste Analyzer
Please observe the following instructions to dispose of the waste analyzer.
WARNING
Materials of the analyzer are subject to contamination regulations.
Dispose of the waste analyzer in accordance with your local or
national guidelines for waste disposal.
Preventing Fire or Explosion
Please observe the following instructions to prevent fire and explosion.
WARNING
Ethanol is flammable substance. Please exercise caution while using
the ethanol.

Foreword
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Precautions on Use
To use the Chemistry Analyzer safely and efficiently, please pay much attention to
the following operation notes.
Intended Use
WARNING
The system is an automated chemistry analyzer for in vitro diagnostic
use in clinical laboratories. The analyzer is designed for the in vitro
quantitative determination of clinical chemistries in serum, plasma,
urine or cerebral spinal fluid samples.
To draw a clinical conclusion, please also refer to the patient’s clinical
symptoms and other test results.
Operator
WARNING
The system is to be operated only by clinical professionals, doctors or
laboratory experimenters trained by our company or our authorized
distributors.
Environment
CAUTION
The electromagnetic environment should be evaluated prior to
operation of the device.
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.

Foreword8
Preventing Interference by Electromagnetic Noise
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 mobile phones or radio
transmitters in the room housing the system. Do not use other CRT
displays 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.
Operating the System
CAUTION
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.
Before using the system for the first time, run the calibration program
and QC program to make sure the system is in normal status.
Be sure to run the QC program every time you use the system,
otherwise the result may be unreliable.
Do not open the covers of the sample/reagent disk cover when the
system is in operation.
The RS-232 port on the analyzing unit is to be used for connection
with the operation unit only. Do not use it for other connections. Only
use the supplied cable for the connection.
The operation unit is a personal computer with the operating software
installed. Installing other software or hardware on this computer may
interfere with the system operation. Do not run other software when
the system is working.
Computer virus may destroy the operating software or test data. Do
not use this computer for other purposes or connect it to the Internet.
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 protection status. If
it does so, switch off the Main Power and switch it on again.
Discard the cuvette after use. Do not use it again.

Foreword 9
Maintaining the System
CAUTION
Maintain the system strictly as instructed by this manual. Inappropriate
maintenance may lead to unreliable results, or even equipment
damage and personal injury.
Dust may accumulate on the system surface when the system is
exposed to the outside for a long time. To wipe off dust from the
system surface, use a soft, clean and wet (not too wet) cloth, soaked
with mild soap solution if necessary, to clean the surface. Do not use
such organic solvents as ethanol for cleaning. After cleaning, wipe the
surface with dry cloth.
Switch off all the powers and unplug the power cord before cleaning.
Take necessary measures to prevent water ingression into the system,
otherwise it may lead to equipment damage or personal injury.
Replacement of such major parts as lamp, photometer, sample probe,
mixer and syringe plunger assembly must be followed by a calibration.
Replacement of lamp must be done after the power has been placed
to off for at least 15 minutes.
Samples
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, icterus or lipemia in the samples may lead to unreliable
test results, so a sample blank is recommended.
Store the samples properly. Improper storage may change the
compositions of the samples and lead to unreliable results.
Sample volatilization may lead to unreliable results. Do not leave the
sample open for a long period.
Some samples may not be analyzed on the system based on
parameters the reagents claim capable of testing. Consult the reagent
manufacturer or distributor for details.
Certain samples need to be processed before being analyzed by the
system. Consult the reagent manufacturer or distributor for details.
The system has specific requirements on the sample volume. Refer to
this manual for details.
Load the sample to correct position on the sample disk before the
analysis begins; otherwise you will not obtain correct results.

Foreword1
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Reagents, Calibrators and Controls
CAUTION
Use appropriate reagents, calibrators and controls on the system.
Select appropriate reagents according to performance characteristic of
the system. Consult the reagent suppliers, our company or our
authorized distributor for details, if you are not sure about your reagent
choice.
Store and use reagents, calibrators and controls strictly as instructed
by the suppliers. Otherwise, you may not obtain reliable results or best
performance of the system.
Improper storage of reagents, calibrators and controls may lead to
unreliable results and bad performance of the system even in validity
period.
Perform a calibration and quality control after changing reagents.
Otherwise, you may not obtain reliable results.
Carryover among reagents may lead to unreliable test results. Consult
the reagent manufacturer or distributor for details.
Setting up the System
CAUTION
To define such parameters as sample volume, reagent volume and
wavelength, follow the instructions in this manual and the package
insert of the reagents.
Backing up Data
NOTE
The system can automatically store data to the built-in hard disk of the
PC. However, data loss is still possible due to mis-deletion or physical
damage of the hard disk. We recommend you to regularly back up the
data to portable storage device.
Computer and Printer
NOTE
Refer to the operation manuals of computer and printer for details.

Foreword 11
External Equipment
WARNING
External equipment connected to the analogue and digital interfaces
must be complied with the 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 work normally and complies
with the safety and EMC requirements. If you have any problem,
consult the technical services department of your local representative.

Foreword12

Contents
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Contents
Intellectual Property Statement............................................................................................ i
Responsibility on the Manufacturer Party............................................................................ i
Warranty ..............................................................................................................................ii
Foreword......................................................................................................................................1
Safety Precautions ............................................................................................................. 4
Precautions on Use ............................................................................................................ 7
1System Description.......................................................................................................1-1
1.1 Hardware Introduction .......................................................................................... 1-1
1.1.1 Analyzing Unit.......................................................................................... 1-1
1.1.2 Operation Unit.......................................................................................... 1-8
1.1.3 Output Unit............................................................................................... 1-8
1.2 Software Introduction............................................................................................ 1-8
1.2.1 Software Interface.................................................................................... 1-8
1.2.2 Screen Elements ..................................................................................... 1-9
2Installation......................................................................................................................2-1
2.1 Unpacking............................................................................................................. 2-1
2.2 Installation Requirements ..................................................................................... 2-1
2.2.1 Environmental Requirements .................................................................. 2-2
2.2.2 Power Requirements ............................................................................... 2-2
2.2.3 Temperature and Humidity Requirements ............................................... 2-2
2.2.4 Water Supply and Drain Requirements ................................................... 2-3
2.2.5 Space and Accessibility Requirements .................................................... 2-3
2.3 Connecting Deionized Water Tank ....................................................................... 2-4
2.4 Connecting Waste Tank ........................................................................................ 2-5
2.5 Installing/Removing Sample/Reagent Disk ..........................................................2-5
2.6 Installing/Removing Sample Tubes ...................................................................... 2-6
2.7 Installing/Removing Sample Tube Rack............................................................... 2-7
2.8 Installing/Removing Reagent Bottles.................................................................... 2-8
2.9 Installing/Removing Cuvettes ............................................................................... 2-8
2.10 Installing/Removing ISE Components (Optional).............................................. 2-9
2.10.1 Installing/Removing Reagent Pack........................................................ 2-9
2.10.2 Installing/Removing Electrodes ........................................................... 2-11
3Basic Operations...........................................................................................................3-1
3.1 General Operating Procedure .............................................................................. 3-2
3.2 Preparing for Analysis........................................................................................... 3-3
3.2.1 Checking before Powering On................................................................. 3-3
3.2.2 Powering On ............................................................................................ 3-4

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3.2.3 Starting the Operating Software............................................................... 3-4
3.2.4 Setting up the Analyzer............................................................................ 3-5
3.2.5 Preparing Reagents................................................................................. 3-6
3.3 Starting Analysis ................................................................................................... 3-6
3.3.1 Programming Reagent Blank .................................................................. 3-6
3.3.2 Programming Calibrators......................................................................... 3-7
3.3.3 Programming Controls............................................................................. 3-7
3.3.4 Programming Samples ............................................................................ 3-7
3.4 Processing Results ............................................................................................... 3-8
3.4.1 Editing Test Results ................................................................................. 3-8
3.4.2 Printing Test Results ................................................................................ 3-8
3.5 Finishing Analysis ................................................................................................. 3-8
3.5.1 Exiting the Operating Software ................................................................ 3-8
3.5.2 Powering Off ............................................................................................ 3-8
3.5.3 Operations after Powering Off ................................................................. 3-9
4Advanced Operations ...................................................................................................4-1
4.1 Sample Request ................................................................................................... 4-1
4.1.1 Sample Information.................................................................................. 4-4
4.1.2 Delete a Sample ...................................................................................... 4-7
4.1.3 Change Position ...................................................................................... 4-8
4.1.4 Requesting Samples or Modifying Information........................................ 4-9
4.1.5 Download Sample Information ................................................................ 4-9
4.2 QC Request ........................................................................................................ 4-10
4.3 Start..................................................................................................................... 4-13
4.4 Probe Stop .......................................................................................................... 4-14
4.5 Stop..................................................................................................................... 4-15
4.6 Results ................................................................................................................ 4-16
4.6.1 Current Results...................................................................................... 4-16
4.6.2 Historical Results ................................................................................... 4-18
4.7 Replace............................................................................................................... 4-34
4.8 Relog .................................................................................................................. 4-36
4.9 Exit ...................................................................................................................... 4-37
4.10 Reagent........................................................................................................... 4-38
4.11 Calibration ....................................................................................................... 4-39
4.11.1 Calibration Request ............................................................................. 4-39
4.11.2 Results ................................................................................................. 4-42
4.11.3 Calibrator.............................................................................................. 4-50
4.11.4 ISE ....................................................................................................... 4-52
4.12 QC................................................................................................................... 4-54
4.12.1 Real-time QC ....................................................................................... 4-54
4.12.2 Daily QC .............................................................................................. 4-55
4.12.3 Day to Day QC..................................................................................... 4-58
4.12.4 Control ................................................................................................. 4-61
4.12.5 QC Summary ....................................................................................... 4-63
4.13 Status .............................................................................................................. 4-66
4.13.1 Sample Disk......................................................................................... 4-66
4.13.2 Reagent Disk ....................................................................................... 4-68

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4.13.3 Reaction Disk....................................................................................... 4-72
4.14 Statistics .......................................................................................................... 4-73
4.14.1 Worklist ................................................................................................ 4-73
4.14.2 Results ................................................................................................. 4-74
4.14.3 Workload.............................................................................................. 4-76
4.14.4 Charges ............................................................................................... 4-79
4.15 Parameters...................................................................................................... 4-81
4.15.1 Test ...................................................................................................... 4-81
4.15.2 ISE ....................................................................................................... 4-92
4.15.3 Profile................................................................................................... 4-93
4.15.4 Calculation ........................................................................................... 4-94
4.15.5 Off-system............................................................................................ 4-96
4.15.6 Carryover ............................................................................................. 4-98
4.16 Setup............................................................................................................... 4-99
4.16.1 System ............................................................................................... 4-100
4.16.2 Hospital.............................................................................................. 4-111
4.16.3 User ................................................................................................... 4-112
4.16.4 Print.................................................................................................... 4-115
4.17 Maintenance.................................................................................................. 4-118
4.17.1 Daily Maintenance ............................................................................. 4-118
4.17.2 ISE ..................................................................................................... 4-119
4.17.3 Log ..................................................................................................... 4-122
4.17.4 Import/Export ..................................................................................... 4-125
4.17.5 Alignment........................................................................................... 4-128
5Service and Maintenance..............................................................................................5-1
5.1 Preparation ........................................................................................................... 5-2
5.1.1 Tools......................................................................................................... 5-2
5.1.2 Wash Solution.......................................................................................... 5-2
5.1.3 Others ...................................................................................................... 5-2
5.2 Daily Maintenance ................................................................................................ 5-3
5.2.1 Checking Remaining Deionized Water .................................................... 5-3
5.2.2 Emptying Waste Tank .............................................................................. 5-3
5.2.3 Checking Connection of Deionized Water............................................... 5-4
5.2.4 Checking Connection of Waste Water..................................................... 5-5
5.2.5 Checking Syringe..................................................................................... 5-5
5.2.6 Checking Probe ....................................................................................... 5-7
5.2.7 Checking Mixing Bar................................................................................ 5-7
5.2.8 ISE Unit (optional).................................................................................... 5-8
5.3 Weekly Maintenance ............................................................................................ 5-9
5.3.1 Cleaning Probe ........................................................................................ 5-9
5.3.2 Cleaning Mixing Bar............................................................................... 5-12
5.3.3 Washing Deionized Water Tank............................................................. 5-13
5.3.4 Washing Waste Tank ............................................................................. 5-13
5.3.5 Cleaning Sample/Reagent Compartment.............................................. 5-14
5.3.6 Cleaning Panel of Analyzing Unit .......................................................... 5-15
5.4 Monthly Maintenance.......................................................................................... 5-15
5.4.1 Cleaning Wash Well of Probe................................................................ 5-15
5.4.2 Cleaning Wash Well of Mixing Bar ........................................................ 5-15

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5.5 Six-month Maintenance ...................................................................................... 5-16
5.5.1 Washing Dust Screen ............................................................................ 5-16
5.5.2 Replacing Filter Assemby ...................................................................... 5-17
5.6 Irregular Maintenance......................................................................................... 5-18
5.6.1 Unclogging Probe .................................................................................. 5-18
5.6.2 Replacing Probe .................................................................................... 5-23
5.6.3 Replacing Mixing Bar............................................................................. 5-23
5.6.4 Replacing Plunger Assembly of Syringe................................................ 5-25
5.6.5 Removing Air Bubbles ........................................................................... 5-27
5.6.6 Replacing Lamp..................................................................................... 5-28
5.6.7 Replacing ISE Components (Optional).................................................. 5-31
5.7 Maintenance Log Sheets .................................................................................... 5-32
6Troubleshooting ............................................................................................................6-1
6.1 Classification of Error Messages .......................................................................... 6-1
6.2 Corrective Measures............................................................................................. 6-5
7Caculation Methods ......................................................................................................7-1
7.1 Reaction Types ..................................................................................................... 7-1
7.1.1 Endpoint................................................................................................... 7-1
7.1.2 Fixed-Time ............................................................................................... 7-2
7.1.3 Kinetic ...................................................................................................... 7-3
7.2 Calculation Process .............................................................................................. 7-4
7.2.1 Calculating Absorbance ........................................................................... 7-5
7.2.2 Calculating Response.............................................................................. 7-6
7.2.3 Calculating Calibration Parameters ......................................................... 7-8
7.2.4 Calculating Concentration...................................................................... 7-11
7.2.5 QC Rule ................................................................................................. 7-13
7.3 Westgard Multi-rule............................................................................................. 7-13
7.4 Calculation Method of ISE Unit (optional)........................................................... 7-14
Appendix A System Specifications................................................................................... A-1
Appendix B Supplies.......................................................................................................... B-1
Appendix C Index................................................................................................................ C-1