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Operator 'S Manual: BS-240 Chemistry Analyzer

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BS-240

Chemistry Analyzer

Operator’s Manual
© 2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator's Manual, the issue date is 2016-03.

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.

BS-240 Operator’s Manual i


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.

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

ii BS-240 Operator’s Manual


Preface

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. Observance of this manual is a prerequisite for proper performance and correct
operation, and it ensures patient and operator 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 actual product should prevail.

Intended audience
This manual is intended for medical laboratory professionals to do the following:
 Learn about the system hardware and software.
 Perform daily operating tasks.
 Maintain and troubleshoot the system.

Product introduction
BS-240 is a computer-controlled fully-automated chemistry analyzer, intended for quantitative
determination of clinical chemistries in serum, plasma, urine, cerebrospinal fluid (CSF), and
other human body fluids. It can fulfill auto dispensing, reaction, colorimetric measurement,
process monitoring, and result calculation. It provides measurement of multiple biochemistries
and ISE (ion-selective electrode) tests (Na+, K+ and Cl-), with maximum throughput up to 400
tests per hour. It is one of the necessary tools for laboratory automation.

Related documents
The following documents are provided for searching information about the instrument:
Operator's Manual
Contains instrument compositions, operating instructions, maintenance and troubleshooting
methods. At the beginning of this manual is a table of contents, which provides references of all
chapters for searching desired information. At the end of this manual is a glossary and index,
which provide term definitions and index to key words.
This manual is based on the maximum configuration and therefore some contents may not
apply to your product. It you have any questions, please contact us.
Operation Card
Provides daily operating procedure for quickly guiding you through basic operations of the
instrument. It includes pre-startup checks and startup, operations before test, routine test, daily
performance and powering off.
Maintenance Card
Provides regular and irregular maintenance of the instrument to help you maintain it so that it
can work normally.
 For detailed maintenance instructions, see the Operator's Manual.

Online help
Contains detailed descriptions of the software screens and parameters. It also covers the
Operator's Manual, which enables you to retrieve information related to the software screens
and operation tasks.

BS-240 Operator’s Manual 1


Preface

Conventions
Graphical symbols, formats and abbreviations are used to get better visual effects and
readability. To help you understand this manual correctly, this section provides statements of
pictures, terms and applicable models used in this manual.
Symbols and formats
The following symbols and formats are used:

Symbol and Meaning


format
A safety symbol, for alerting you to warnings about safety and
system operations.
Alerts you to biohazards.

 Item list.
 Reference content or cross reference.
Bold Headings or important information.
Italic Key points.
 Start of operating procedure.
Picture
All pictures in this manual are for illustration purpose only and must not be used for any other
purposes. The pictures of the actual product should prevail.
Terms
The analyzer has one probe for adding sample and reagent. If not specifically stated, it is
referred to as "probe". For emphasis purpose in software operations, "sample probe" is used for
adding sample, and "reagent probe" is used for adding reagent.
The analyzer has one carousel for holding sample and reagent. If not specifically stated, it is
referred to as "sample/reagent carousel". For emphasis purpose in software operations,
"sample carousel" is used for sample, and "reagent carousel " is used for reagent.

Online help
The operating software provides a context-sensitive online help, which can help you better
understand the screen parameters and perform correct operations. The online help is related to
software screens, and it can display information related to menu page, maintenance item,
maintenance command, and event log.
You can open the online help window in the following ways:
 Alt+F1: press this shortcut key combination on any screen.
 : click this icon on the top-right of any screen.
 : click this button to the left of a maintenance item, a maintenance command, or an event
log.

2 BS-240 Operator’s Manual


Safety information

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 silkscreens that have been
applied to the instrument and their indications.

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 warning as shown in the table below:

Symbol Text Description


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.

Summary of hazards
This section lists hazards of the instrument itself. The hazards of specific operation are included
in the warning information of each operation task.
Observe the following safety precautions when using the product. Ignoring any of them may
lead to personal injury or equipment damage.

BS-240 Operator’s Manual 3


Safety information

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

WARNING
 When the MAIN 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 product. 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

WARNING
 Do not touch such moving parts as sample/reagent carousel, reaction carousel, probe, mixer, and cuvette
wash station, when the system is in operation.
 Exercise caution while using the ISE module Prevent your hair, legs or other parts of your body from being
hurt by the driving parts.
 Do not put your fingers or hands into any open part when the system is in operation.
Photometer lamp hazards

WARNING
 Eye injury could occur from light emission from the photometer lamp. 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 10
minutes for the lamp to cool down before touching it. Do not touch the lamp before it cools down, or you
may get burned.
Laser beam hazards

WARNING
Light emitted by the bar code reader may cause eye injury. Do not stare into the laser beam radiated from the
bar code reader when the system is in operation.
Sample, calibrator and control hazards

BIOHAZARD
 Inappropriately handling samples, controls and calibrators may lead to biohazardous infection. Do not touch
samples, controls, calibrators, mixtures, or waste with your bare hands. Wear gloves and lab coat and, if
necessary, goggles.
 In case your skin contacts the sample, control or calibrator, follow the standard laboratory safety procedure
and consult a doctor.
 The serum samples remaining in the electrodes may contain a great number of viruses. Wear gloves to
prevent infection while operating around the electrodes.

4 BS-240 Operator’s Manual


Safety information

Reagent and wash solution hazards

WARNING
Reagents and concentrated wash solution 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 soap and clean
water. If reagents or wash solution spills into your eyes, rinse them with much water and consult an oculist.
Waste hazards

BIOHAZARD
 Some substances contained in reagent, control, calibrator, concentrated wash solution, 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

WARNING
Materials of the analyzer are subject to contamination regulations. Dispose of the waste analyzer in accordance
with your local or national rule for waste disposal.
Fire and explosion hazards

WARNING
Ethanol is flammable substance. Please exercise caution while using ethanol around the instrument in order to
prevent fire and explosion.
Removal of analyzer from use for repair or disposal

WARNING
When the analyzer is not in use, for example, in repair, transportation or disposal process, please clean and
sterilize the parts that may cause biohazards(probe, mixer, etc.) and remind the person who handles the device
of the related hazards.

Summary of precautions
This section lists precautions to be understood during instrument operation. The precautions of
specific operation are included in the warning information of each operation task.
To use the product safely and efficiently, pay attention to the following operating precautions.

BS-240 Operator’s Manual 5


Safety information

Intended use

WARNING
The instrument is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories and
designed for in vitro quantitative determination of clinical chemistries in serum, plasma, urine and cerebrospinal
fluid samples. Please consult us before you use the instrument for other purposes.
When drawing a clinical conclusion, please also refer to patients' clinical symptoms and other test results.
Environment precautions

CAUTION
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.
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 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.
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.

NOTE
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.

6 BS-240 Operator’s Manual


Safety information

Operating precautions

CAUTION
 Take the clinical symptoms or other test results of the patient into considerations when making 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.
 When using the system for the first time, run calibrations and 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.
 The RS-232 port on the analyzing unit is used for connection with the operation unit only. Do not use it for
other connections. Use the cables provided by our company or your local distributor for the connection.
 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 after 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.
Chemistry parameter configuration precautions

CAUTION
To define such parameters as sample volume, reagent volume and wavelength, follow the instructions in this
manual and the instructions of reagents.

BS-240 Operator’s Manual 7


Safety information

ISE module precautions

CAUTION
To prevent ISE electrodes from being damaged due to water scarcity, if the system, when equipped with an ISE
module will be powered off for a long time, perform the electrode storage maintenance.
Sample precautions

CAUTION
 Use samples that are completely free of insoluble substances like fibrin or suspended matter; otherwise the
sample probe may be clogged.
 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; running a sample blank
therefore, is recommended.
 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.
 Prepare sufficient sample volume before analysis.
 Load samples to correct positions on the sample carousel before the analysis begins; otherwise reliable
results may not be obtained.
Reagent, calibrator and control precautions

CAUTION
 Use proper reagents, calibrators and controls on the system.
 Select appropriate reagents according to the performance characteristics 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 the reagents, calibrators and controls strictly as instructed by the suppliers; 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 after changing the reagents, otherwise reliable results may not be obtained.
 Contamination caused by carryover among reagents may lead to unreliable test results. Consult the
reagent suppliers for details.
ISE calibration precautions

BIOHAZARD
The calibrators contain preservatives. In case your skin contacts calibrators, wash them off with soap and water.
In case the calibrators spill into your eyes, rinse them with water and consult an oculist. If you swallow them by
mistake, see a doctor.

8 BS-240 Operator’s Manual


Safety information

CAUTION
Use the calibrators specified by our company. Use of other reagents or calibrators may result in unreliable
results, or damage the Hydropneumatic system, or even shorten the electrodes life span.
Prior to using the calibrators, check if they are within the expiration date.
Place them correctly; otherwise, it may cause unreliable results, or leak, or module damage.
ISE wash solution biohazards

BIOHAZARD
The ISE wash solution is sodium hypochlorite. Use the ISE wash solution carefully to prevent it from contacting
your skins or eyes. If your skins or eyes contact the ISE wash solution, rinse them off with fresh water and
consult a doctor.
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 the data loss caused by unexpected power failure, UPS (uninterrupted power supply) is
recommended.
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 authorized and 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.

BS-240 Operator’s Manual 9


Safety information

Labels and silkscreen


The following non-warning and warning labels and silkscreen are used on the product for
system identification and operating instruction.
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
This symbol, contained in the product label which is attached to the rear cover of the system,
indicates the manufacture date of the product.

In vitro diagnostic equipment


This symbol, contained in the product label which is attached to the rear cover of the system,
indicates that the product is in vitro diagnostic equipment.

European community representative


This symbol, contained in the product label which is attached to the rear cover of the system,
indicates the name and address of the authorized representative in the European Community.

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.

10 BS-240 Operator’s Manual


Safety information

Main power switch: ON


This symbol located on the main power switch indicates that the system power is on when the
switch is toggled rightwards to expose this symbol and ON character and the green light is
lightened.

Main power switch: OFF


This symbol located on the main power switch indicates that the system power is off when the
switch is toggled leftwards to expose this symbol and OFF character and the green light is
extinguished. All components including the reagent refrigeration system will be stopped.

Analyzer power switch


This symbol located on the analyzer power switch indicates that the analyzer power is on when
the switch is on the dotted-circle portion and off when it is on the blank-circle portion.

Network interface
This symbol located on the network interface indicates the connection between the analyzer
and the operation unit.

BS-240 Operator’s Manual 11


Safety information

Serial port
This symbol located on the serial port indicates the connection between the analyzer and the
operation unit.

Electrical ground
This symbol indicates an electrical ground.

Interfaces for fluid connection


This symbol located on the right panel of the analyzer indicates the connection of fluid tubing.

12 BS-240 Operator’s Manual


Safety information

Warning labels
Biohazard warning
This label indicating the risk of biohazardous infection is located in the following positions:
 Probe
 Waste outlet
 Waste tank

Moving parts warning


This symbol and text indicating the hazardous moving parts is located in the following positions:
 Probe
 Mixer
 Wash station

Laser warning
This symbol and text located near the bar code reader reminds you of not staring into the laser
beam.

Photometer lamp warning


This symbol and text located on the lamp housing reminds you of not touching the lamp before
it gets cool.

Probe collision warning


This symbol and text located near the sample/reagent carousel and reaction carousel reminds
you of not opening the cover to prevent from damaging the probe.

BS-240 Operator’s Manual 13


Safety information

Upper cover
This symbol and text located on the transparent upper cover reminds you of not wipe the upper
cover with ethanol or other organic solutions.

ISE module
This symbol and text located on the left side panel of the analyzer. Please turn off the main
power before opening the small door.

Liquid level floater


This symbol and text is located near the liquid level floater of the DI water tank and the wash
solution tank, Please do not take out the liquid level floater during test.

Cuvette replacement window


This symbol and text is located on the cuvette replacement window.

14 BS-240 Operator’s Manual


Table of contents
Intellectual Property Statement ...............................................................................................................................................i
Responsibility on the Manufacturer Party...........................................................................................................................i
Warranty ......................................................................................................................................................................................... ii
Exemptions ...................................................................................................................................................................... ii
Customer service department ................................................................................................................................. ii
EC - Representative ...................................................................................................................................................... ii
Preface ............................................................................................................................................................................................. 1
Intended audience ........................................................................................................................................................ 1
Product introduction .................................................................................................................................................... 1
Related documents ........................................................................................................................................................ 1
Conventions..................................................................................................................................................................... 2
Online help ....................................................................................................................................................................... 2
Safety information ····················································································································· 3
Safety symbols............................................................................................................................................................................... 3
Summary of hazards................................................................................................................................................................... 3
Summary of precautions .......................................................................................................................................................... 5
Labels and silkscreen .............................................................................................................................................................. 10
Non-warning labels and silkscreen..................................................................................................................... 10
Warning labels ............................................................................................................................................................. 13
Table of contents ····················································································································· 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 components .................................................................................................................................................. 1-5
1.2.1 Overview ........................................................................................................................................................... 1-5
1.2.2 Sample/Reagent handling system .......................................................................................................... 1-6
1.2.3 Mixer assembly ............................................................................................................................................ 1-12
1.2.4 Reaction system .......................................................................................................................................... 1-12
1.2.5 Cuvette wash station .................................................................................................................................. 1-13
1.2.6 Photometric system ................................................................................................................................... 1-14
1.2.7 ISE unit (optional) ...................................................................................................................................... 1-14
1.2.8 Operation unit .............................................................................................................................................. 1-15
1.2.9 Output unit .................................................................................................................................................... 1-15
1.2.10 Accessories and consumables............................................................................................................. 1-16
1.3 Software description .................................................................................................................................................... 1-17
1.3.1 Screen areas .................................................................................................................................................. 1-17
1.3.2 Screen elements ........................................................................................................................................... 1-20
1.3.3 Software hierarchy ..................................................................................................................................... 1-24
1.3.4 Using the mouse .......................................................................................................................................... 1-25
1.3.5 Using online help......................................................................................................................................... 1-26

BS-240 Operator’s Manual 15


Table of contents

1.4 System specifications .................................................................................................................................................. 1-27


1.4.1 Analyzing unit .............................................................................................................................................. 1-27
1.4.2 Power supply requirements ................................................................................................................... 1-29
1.4.3 Environment requirements .................................................................................................................... 1-29
1.4.4 Dimensions and weight ........................................................................................................................... 1-29
1.4.5 Noise and fuse .............................................................................................................................................. 1-30
1.4.6 Input device ................................................................................................................................................... 1-30
1.4.7 Output device ................................................................................................................................................ 1-30
1.4.8 Communication interfaces ...................................................................................................................... 1-30
1.4.9 Safety classification .................................................................................................................................... 1-30
1.4.10 EMC requirements ................................................................................................................................... 1-31
2 Daily operating procedure ····································································································· 2-1
2.1 Daily operating procedure ........................................................................................................................................... 2-2
2.2 Startup and daily checks ................................................................................................................................................ 2-2
2.2.1 Checks before startup................................................................................................................................... 2-2
2.2.2 Startup ................................................................................................................................................................ 2-3
2.2.3 Checking system status................................................................................................................................ 2-6
2.3 Operations before routine test ................................................................................................................................ 2-10
2.3.1 Preparing reagents ..................................................................................................................................... 2-10
2.3.2 Calibration ..................................................................................................................................................... 2-16
2.3.3 QC ...................................................................................................................................................................... 2-20
2.4 Routine test ..................................................................................................................................................................... 2-22
2.4.1 Programming and processing samples .............................................................................................. 2-23
2.4.2 Checking test results .................................................................................................................................. 2-25
2.4.3 Checking test status and performing test control ......................................................................... 2-26
2.5 Daily maintenance and powering off ................................................................................................................... 2-28
2.5.1 Daily maintenance...................................................................................................................................... 2-29
2.5.2 Powering off.................................................................................................................................................. 2-29
2.5.3 Operations after powering off ............................................................................................................... 2-29
3 Reagent ······························································································································ 3-1
3.1 Special reagent .................................................................................................................................................................. 3-2
3.1.1 ISE reagent/calibration screen ................................................................................................................ 3-2
3.1.2 Loading special reagents in Running status ........................................................................................ 3-2
3.1.3 Unloading special reagents......................................................................................................................... 3-3
3.1.4 Printing ISE reagent/calibration list ..................................................................................................... 3-3
3.2 Biochemistry reagent ..................................................................................................................................................... 3-3
3.2.1 Biochemistry reagent/calibration screen............................................................................................ 3-3
3.2.2 Sorting reagents.............................................................................................................................................. 3-4
3.2.3 Loading biochemistry reagents in Running status ........................................................................... 3-4
3.2.4 Unloading biochemistry reagents ............................................................................................................ 3-4
3.2.5 Customizing reagent display ..................................................................................................................... 3-5
3.2.6 Setting up reagent alarm limit .................................................................................................................. 3-6
3.2.7 Checking and auto refreshing reagent inventory ............................................................................ 3-6
4 Calibration ·························································································································· 4-1
4.1 ISE calibration ................................................................................................................................................................... 4-2
4.1.1 Calibration setup ............................................................................................................................................ 4-2

16 BS-240 Operator’s Manual


Table of contents

4.1.2 Calibration status and alarm ...................................................................................................................... 4-2


4.1.3 Results recall .................................................................................................................................................... 4-3
4.2 Biochemistry calibration ............................................................................................................................................... 4-5
4.2.1 Calibration setup ............................................................................................................................................ 4-5
4.2.2 Calibration status and alarm ................................................................................................................... 4-11
4.2.3 Reagent blank ............................................................................................................................................... 4-12
4.2.4 Recalling calibration results ................................................................................................................... 4-15
5 QC ····································································································································· 5-1
5.1 Overview ............................................................................................................................................................................. 5-2
5.1.1 QC procedure ................................................................................................................................................... 5-2
5.1.2 QC result flags .................................................................................................................................................. 5-2
5.1.3 Control status ................................................................................................................................................... 5-2
5.2 QC setup ............................................................................................................................................................................... 5-3
5.2.1 Defining/Editing a control ......................................................................................................................... 5-3
5.2.2 Setting up control concentrations ........................................................................................................... 5-4
5.2.3 Setting up QC rules ........................................................................................................................................ 5-4
5.2.4 Auto QC .............................................................................................................................................................. 5-5
5.2.5 Deleting a control ........................................................................................................................................... 5-6
5.3 Recalling control results ................................................................................................................................................ 5-6
5.3.1 Result > History screen ............................................................................................................................... 5-6
5.3.2 Levey-Jennings screen ................................................................................................................................. 5-8
5.3.3 Recalling cumulative sum chart ............................................................................................................... 5-9
5.3.4 Recalling Twin-Plot chart ........................................................................................................................ 5-10
5.3.5 QC > Results screen .................................................................................................................................... 5-11
5.3.6 Recalling QC Summary ............................................................................................................................. 5-13
6 Program······························································································································ 6-1
6.1 Sample management ...................................................................................................................................................... 6-2
6.2 Sample programming and processing ..................................................................................................................... 6-3
6.2.1 Processing samples with LIS ..................................................................................................................... 6-3
6.2.2 Processing bar-coded samples ................................................................................................................. 6-4
6.2.3 Batch programming...................................................................................................................................... 6-5
6.2.4 Adding samples ............................................................................................................................................... 6-6
6.2.5 Adding/Modifying chemistries ................................................................................................................. 6-7
6.2.6 Rerunning samples........................................................................................................................................ 6-7
6.2.7 Sample blank ................................................................................................................................................. 6-12
6.2.8 Whole Blood Test ......................................................................................................................................... 6-13
6.3 Extended functions ....................................................................................................................................................... 6-14
6.3.1 Clearing samples .......................................................................................................................................... 6-14
6.3.2 Sample and chemistry lists ...................................................................................................................... 6-15
6.3.3 Viewing unpositioned samples ............................................................................................................. 6-17
6.3.4 Releasing sample position ....................................................................................................................... 6-18
6.3.5 View sample logs ......................................................................................................................................... 6-19
6.3.6 Customizing sample information ......................................................................................................... 6-20
6.3.7 Customizing patient demographics ..................................................................................................... 6-21
6.3.8 Optimizing result display ......................................................................................................................... 6-21
6.4 Results Recall .................................................................................................................................................................. 6-23

BS-240 Operator’s Manual 17


Table of contents

6.4.1 Viewing current results ............................................................................................................................ 6-23


6.4.2 Viewing history results............................................................................................................................. 6-24
6.4.3 Reviewing sample results ........................................................................................................................ 6-26
6.4.4 Viewing/Editing patient demographics ............................................................................................ 6-26
6.4.5 Viewing reaction curve ............................................................................................................................ 6-27
6.4.6 Sending results to LIS host ...................................................................................................................... 6-30
6.4.7 Printing results............................................................................................................................................. 6-31
6.4.8 Editing results ............................................................................................................................................... 6-32
6.4.9 Deleting results ............................................................................................................................................. 6-34
6.4.10 Customizing result display ................................................................................................................... 6-34
6.4.11 Recalculating results ................................................................................................................................ 6-36
6.4.12 Compensating results ............................................................................................................................. 6-36
6.4.13 Recalling result trend ............................................................................................................................. 6-37
6.4.14 Archiving results ....................................................................................................................................... 6-38
6.5 Test statistics ................................................................................................................................................................... 6-38
6.6 Result statistics............................................................................................................................................................... 6-40
7 Chemistry ··························································································································· 7-1
7.1 Importing/Exporting chemistries ............................................................................................................................. 7-2
7.1.1 Importing default chemistry list .............................................................................................................. 7-2
7.1.2 Importing specified chemistry list.......................................................................................................... 7-3
7.1.3 Exporting chemistries .................................................................................................................................. 7-4
7.2 Biochemistry setup .......................................................................................................................................................... 7-4
7.2.1 User-defined chemistry setup ................................................................................................................... 7-5
7.2.2 Processing parameters................................................................................................................................ 7-6
7.2.3 Error detection limits................................................................................................................................. 7-10
7.2.4 Using qualitative result ............................................................................................................................. 7-13
7.2.5 Slope and offset adjustment ................................................................................................................... 7-14
7.2.6 Reference/Critical range setup ............................................................................................................. 7-15
7.3 ISE chemistry setup ...................................................................................................................................................... 7-17
7.3.2 Viewing ISE chemistry parameters..................................................................................................... 7-17
7.3.3 Description of ISE chemistry parameters ........................................................................................ 7-17
7.3.4 Using ISE qualitative result ..................................................................................................................... 7-18
7.4 Chemistry configuration ............................................................................................................................................ 7-19
7.4.1 Enabling chemistries ................................................................................................................................. 7-19
7.4.2 Disabling chemistries ................................................................................................................................ 7-20
7.4.3 Customizing chemistry display order ................................................................................................. 7-20
7.4.4 Adjusting test order of chemistries ..................................................................................................... 7-21
7.5 Twin chemistry .............................................................................................................................................................. 7-22
7.5.1 Chemistry definition .................................................................................................................................. 7-22
7.5.2 Removing twin relation ............................................................................................................................ 7-22
7.5.3 Reagent setup ............................................................................................................................................... 7-22
7.5.4 Setting up and requesting calibration ................................................................................................ 7-23
7.5.5 Setting up and requesting quality control ......................................................................................... 7-23
7.5.6 Sample programming and processing ............................................................................................... 7-23
7.6 Special Calculations ...................................................................................................................................................... 7-23
7.6.1 Defining/Editing a calculation ............................................................................................................... 7-23

18 BS-240 Operator’s Manual


Table of contents

7.6.2 Enabling/Disabling calculations ........................................................................................................... 7-24


7.6.3 Deleting user-defined calculations ........................................................................................................ 7-25
7.6.4 Running calculations .................................................................................................................................. 7-25
7.7 Panels ................................................................................................................................................................................. 7-25
7.7.1 Defining/Editing a panel ......................................................................................................................... 7-25
7.7.2 Adjusting display order of panels ......................................................................................................... 7-26
7.7.3 Deleting panels ............................................................................................................................................. 7-26
7.7.4 Running panels ............................................................................................................................................ 7-26
7.7.5 Setting up and running default panel ................................................................................................. 7-26
7.8 Off-system chemistry .................................................................................................................................................. 7-27
7.8.1 Defining/Editing off-system chemistry ............................................................................................. 7-27
7.8.2 Running off-system chemistry .............................................................................................................. 7-28
7.8.3 Deleting off-system chemistry ............................................................................................................... 7-28
7.9 Carryover setup ............................................................................................................................................................. 7-28
7.9.1 Defining/Editing carryover pair........................................................................................................... 7-29
7.9.2 Removing a carryover pair ..................................................................................................................... 7-29
7.10 Masking/Unmasking chemistries........................................................................................................................ 7-30
7.11 Reflex ............................................................................................................................................................................... 7-31
7.11.1 Setting up reflex relation ........................................................................................................................ 7-31
7.11.2 Editing reflex relation.............................................................................................................................. 7-32
7.11.3 Deleting reflex relation............................................................................................................................ 7-32
7.11.4 Measurement and result recall .......................................................................................................... 7-32
8 Utility·································································································································· 8-1
8.1 System commands ........................................................................................................................................................... 8-2
8.1.1 Home................................................................................................................................................................... 8-2
8.1.2 Stop print .......................................................................................................................................................... 8-2
8.2 System setup ...................................................................................................................................................................... 8-2
8.2.2 Sample test setup page ................................................................................................................................ 8-3
8.2.3 Auto rerun setup ............................................................................................................................................ 8-5
8.3 Instrument setup .............................................................................................................................................................. 8-6
8.3.1 Auto startup setup ......................................................................................................................................... 8-6
8.3.2 Masking/Unmasking Chemistries .......................................................................................................... 8-7
8.3.3 Dictionary setup ............................................................................................................................................. 8-7
8.3.4 System communication options .............................................................................................................. 8-8
8.3.5 Selecting language .......................................................................................................................................... 8-8
8.3.6 Software upgrading....................................................................................................................................... 8-9
8.3.7 Viewing software versions ........................................................................................................................ 8-9
8.3.8 Setting up system date and time ........................................................................................................... 8-10
8.3.9 Setting up QC run length and auto QC ................................................................................................ 8-11
8.3.10 Auto release of samples ......................................................................................................................... 8-11
8.3.11 Voice tone setup........................................................................................................................................ 8-11
8.3.12 Optimizing result display ...................................................................................................................... 8-12
8.3.13 Customizing sample information ...................................................................................................... 8-12
8.3.14 Customizing patient demographics .................................................................................................. 8-12
8.3.15 Reagent/Calibration setup ................................................................................................................... 8-12
8.3.16 Customizing reagent display ............................................................................................................... 8-12

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Table of contents

8.3.17 Customizing sample position .............................................................................................................. 8-13


8.4 Print setup........................................................................................................................................................................ 8-13
8.4.1 General print setup options .................................................................................................................... 8-13
8.4.2 Editing print template ............................................................................................................................... 8-14
8.4.3 Importing print template......................................................................................................................... 8-14
8.4.4 Setting up default template...................................................................................................................... 8-15
8.4.5 Deleting a template ..................................................................................................................................... 8-15
8.4.6 Defining chemistry print order ............................................................................................................. 8-15
8.5 Bar code setup ................................................................................................................................................................ 8-16
8.6 LIS setup ........................................................................................................................................................................... 8-18
8.6.1 Introduction................................................................................................................................................... 8-18
8.6.2 Setting up host communication parameters ................................................................................... 8-19
8.6.3 Defining channel number of chemistries ......................................................................................... 8-21
8.7 User and Password Setup .......................................................................................................................................... 8-21
8.7.1 Defining a user ............................................................................................................................................. 8-21
8.7.2 Modifying a user ......................................................................................................................................... 8-22
8.7.3 Assigning/Modifying permissions ...................................................................................................... 8-23
8.7.4 Deleting a user.............................................................................................................................................. 8-23
9 Template modifying software ································································································· 9-1
9.1 Main screen ........................................................................................................................................................................ 9-2
9.1.1 Main screen ...................................................................................................................................................... 9-2
9.1.2 File (F) ................................................................................................................................................................ 9-2
9.1.3 Edit (E) ............................................................................................................................................................... 9-4
9.1.4 View (V)............................................................................................................................................................. 9-5
9.1.5 Insert (I) ............................................................................................................................................................ 9-6
9.1.6 Format (M) ....................................................................................................................................................... 9-7
9.1.7 Set(S) .................................................................................................................................................................. 9-8
9.1.8 Language (L) .................................................................................................................................................... 9-8
9.1.9 Help (H) ............................................................................................................................................................. 9-9
9.1.10 Page .................................................................................................................................................................. 9-9
9.2 Common tools ................................................................................................................................................................. 9-10
9.3 Draw tools ........................................................................................................................................................................ 9-10
9.4 Property window ........................................................................................................................................................... 9-11
9.4.1 Line ................................................................................................................................................................... 9-11
9.4.2 Rectangle ......................................................................................................................................................... 9-12
9.4.3 Label ................................................................................................................................................................. 9-12
9.4.4 Text ................................................................................................................................................................... 9-14
9.4.5 Title ................................................................................................................................................................... 9-15
9.4.6 Image ............................................................................................................................................................... 9-16
9.5 Report window ............................................................................................................................................................... 9-16
10 Maintenance ····················································································································· 10-1
10.1 Overview ........................................................................................................................................................................ 10-2
10.1.1 Safety information ................................................................................................................................... 10-2
10.1.2 Tools and Spare Parts .............................................................................................................................. 10-2
10.1.3 Concepts ....................................................................................................................................................... 10-3
10.1.4 Maintenance period ................................................................................................................................ 10-5

20 BS-240 Operator’s Manual


Table of contents

10.1.5 Maintenance execution methods ....................................................................................................... 10-5


10.1.6 Extended operations of maintenance item.................................................................................... 10-6
10.2 Scheduled maintenance and maintenance commands ............................................................................... 10-7
10.2.1 Scheduled maintenance ......................................................................................................................... 10-7
10.2.2 Biochemistry maintenance commands ........................................................................................... 10-8
10.2.3 ISE maintenance commands ............................................................................................................... 10-9
10.3 Maintenance log sheet ........................................................................................................................................... 10-10
10.4 Daily maintenance .................................................................................................................................................. 10-13
10.4.1 Checking probe/mixer/wash well................................................................................................. 10-13
10.4.2 Checking DI water tank and tube connection............................................................................ 10-14
10.4.3 Checking diluted wash solution tank and tube connection .................................................. 10-14
10.4.4 Checking waste connection and waste tank connection ...................................................... 10-15
10.4.5 Checking probe wash solution......................................................................................................... 10-15
10.4.6 Cleaning electrode tubes ...................................................................................................................... 10-16
10.4.7 Checking Sample/Reagent Syringe ................................................................................................ 10-17
10.5 Weekly maintenance.............................................................................................................................................. 10-18
10.5.1 Cleaning probe exterior ...................................................................................................................... 10-18
10.5.2 Clean the mixer ...................................................................................................................................... 10-19
10.5.3 Special Wash ........................................................................................................................................... 10-20
10.5.4 Cuvette check .......................................................................................................................................... 10-20
10.5.5 Photometer check ................................................................................................................................. 10-21
10.6 Three-month maintenance ................................................................................................................................. 10-22
10.6.1 Cleaning DI water tank ........................................................................................................................ 10-22
10.6.2 Cleaning diluted wash solution tank .............................................................................................. 10-23
10.7 Monthly maintenance ........................................................................................................................................... 10-23
10.7.1 Cleaning wash wells.............................................................................................................................. 10-23
10.7.2 Cleaning wash station and tubes ..................................................................................................... 10-24
10.7.3 Cleaning sample injection port ........................................................................................................ 10-25
10.7.4 Pump calibration ................................................................................................................................... 10-25
10.7.5 Air bubble detector calibration ........................................................................................................ 10-26
10.8 Six-month maintenance ....................................................................................................................................... 10-26
10.8.1 Replacing lamp ....................................................................................................................................... 10-26
10.9 As-needed/As-required maintenance ............................................................................................................ 10-27
10.9.1 Cleaning analyzer panels .................................................................................................................... 10-28
10.9.2 Cleaning sample/reagent compartment ...................................................................................... 10-28
10.9.3 Cleaning probe interior ...................................................................................................................... 10-29
10.9.4 Cleaning rotor ......................................................................................................................................... 10-31
10.9.5 Replacing the probe ............................................................................................................................. 10-31
10.9.6 Replacing the mixer.............................................................................................................................. 10-32
10.9.7 Removing Air Bubbles in Syringe ................................................................................................... 10-34
10.9.8 Replacing Syringe .................................................................................................................................. 10-35
10.9.9 Replacing cuvette................................................................................................................................... 10-36
10.9.10 Special wash probe ............................................................................................................................ 10-37
10.9.11 Bar code maintenance ...................................................................................................................... 10-38
10.9.12 Replacing ISE electrode ..................................................................................................................... 10-38
10.9.13 Removing reagent pack ................................................................................................................... 10-40

BS-240 Operator’s Manual 21


Table of contents

10.9.14 Storing electrodes................................................................................................................................ 10-40


10.9.15 Cleaning ISE waste tube ................................................................................................................... 10-41
11 Alarms and troubleshooting ································································································ 11-1
11.1 Classification of logs................................................................................................................................................... 11-2
11.1.1 Error logs ..................................................................................................................................................... 11-2
11.1.2 Edit logs ........................................................................................................................................................ 11-3
11.2 Viewing and handling logs ..................................................................................................................................... 11-3
11.2.1 Description of Error Log screen ........................................................................................................ 11-3
11.2.2 Description of Edit Log screen ........................................................................................................... 11-4
11.2.3 Recalling logs.............................................................................................................................................. 11-4
11.2.4 Refreshing Logs ........................................................................................................................................ 11-5
11.2.5 Clearing logs ................................................................................................................................................ 11-5
11.2.6 Printing logs................................................................................................................................................ 11-5
11.3 Error Troubleshooting.............................................................................................................................................. 11-5
11.3.1 Error indications ...................................................................................................................................... 11-6
11.3.2 Identifying errors ..................................................................................................................................... 11-7
11.4 Data alarms.................................................................................................................................................................... 11-7
11.4.1 Data alarms and corrective actions ................................................................................................... 11-9
11.5 Error Messages and Corrective Actions ......................................................................................................... 11-21
12 Operation theories ············································································································· 12-1
12.1 Overview ........................................................................................................................................................................ 12-2
12.2 Principles of measurement .................................................................................................................................... 12-2
12.2.1 Endpoint measurements ....................................................................................................................... 12-2
12.2.2 Fixed-time measurements .................................................................................................................... 12-4
12.2.3 Calculation of Response ......................................................................................................................... 12-4
12.2.4 Kinetic measurements ........................................................................................................................... 12-4
12.3 Calibration math model and factors ................................................................................................................... 12-8
12.3.1 Linear calibrations .................................................................................................................................. 12-8
12.3.2 Non-Linear Calibrations ........................................................................................................................ 12-8
12.4 QC evaluation ............................................................................................................................................................ 12-10
12.4.1 Evaluation of single controls.............................................................................................................. 12-10
12.4.2 Two-control evaluation ....................................................................................................................... 12-11
12.5 Prozone Check .......................................................................................................................................................... 12-13
12.5.1 Introduction ............................................................................................................................................. 12-13
12.5.2 Rate check method ............................................................................................................................... 12-13
12.6 Principles of ISE measurement.......................................................................................................................... 12-14
Glossary··································································································································· 1
Index········································································································································ 1

22 BS-240 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
 Introduction of software screens
 Technical specifications

BS-240 Operator’s Manual 1-1


1.1 Installation requirements and procedure 1 System description

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 intended.

Installation environment
The following environment requirements must be satisfied:
 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 130Kg weight.
 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 -400-2000 m.

Power supply
The following power supply requirements must be satisfied:
 Connect the system to a power supply meeting the requirements specified in this
manual.
For more information on power supply, see 1.4.2Power supply requirements on page 1-29.
 Use the three-wire power cord provided with the system, which has good grounding
performance.
 Connect the system to a properly-grounded power socket.
 Configure the grounding voltage correctly.

WARNING
Make sure the power socket is grounded correctly. Improper grounding may lead to electric shock or equipment
damage. Check if the power sockets outputs voltage meeting the specified requirements and has a proper fuse
installed.

Temperature and humidity


The following temperature and humidity requirements must be satisfied:
 Ambient temperature: 15°C-30°C
 Relative humidity: 35%-85%, without condensation

1-2 BS-240 Operator’s Manual


1 System description 1.1 Installation requirements and procedure

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.

Water supply and drainage


The supplied water must meet the requirements of CLSI type II, with resistance more than
1MΩ.CM. and silicate lower than 0.1 mg/L.

CAUTION
The water supply must meet the requirements; otherwise insufficiently purified water may result in misleading
test results.

The high-/low-concentration waste produced during cuvette wash are drained separately. The
high-concentration waste is discharged to the provided 10 L waste tank, and the
low-concentration waste is discharged to the provided 15 L waste tank or to a drain outlet.

BIOHAZARD
Dispose of the waste liquid according to the local regulations.

After installing the instrument, connect it with the fluidic components as instructed in the figure
below.

BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.

CAUTION
When connecting the tubes, exercise caution to avoid folding or pressing them.

Figure 1.1 Fluidic connection diagram

Fluidic interface panel

Diluted wash Low-conc. Low-conc. High-conc.


DI water inlet waste outlet2
solution inlet waste outlet1 waste outlet

Diluted wash High-concentration


solution low waste high level
DI water level floater
low level floater
floater

FL02 FL04
FL03

FL01

DI water tank Diluted wash solution tank Low-conc. waste tank High-conc. waste tank

Space and accessibility requirements


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

BS-240 Operator’s Manual 1-3


1.1 Installation requirements and procedure 1 System description

Figure 1.2 System clearances

Wall

Min. 500
Maximum of 3000

Min. 500
585 Operation Unit

Analyzing Unit

Front
695
Min. 500

Min. 500 Unit: mm

Recommended computer configuration


Table 1.1 Recommended computer configuration
Item Description
CPU At least P4 2.6GHz or above
Random access memory At least 2GB or above for each RAM
(RAM)
Network adapter The computer is connected to the chemistry 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 The computer should provide an RS232 serial port, which is used
to connect it with the chemistry analyzer.
Parallel port or USB Used for connecting the operation unit with a printer or an
interface external storage device.
Network interface Used for communication between the analyzing unit and the
operation unit, or between the LIS and the operation unit.
Hard disk defragment At least 160GB or above for hard disk. Install the operating system
in the C drive and the operating software of the instrument in the D
drive. Make sure that the C drive is over 30G and D drives over
100G, and the disk file system is of NTFS format. Deselect the two
options at the bottom of the disk properties window: "Compress
drive to save disk space" and "Allow Indexing Service to index this
disk for fast file searching".
Operating system The operating system installed on the computer must be an
activated or free version Microsoft Windows 8(64 bit).
Application software Except for the operating system, other application software must
not be installed or reserved on the computer. If an anti-virus
application has been installed, then remove the automatic
scheduled scanning and add the operating software and BSLOG to
the trust list.
Screen saver and system Turn off the screen saver and BS Special Power Policy power
standby scheme, and then disable the hibernation option.
Screen display Set the screen resolution as 1280*1024 pixels and color quality as
properties Highest (32 bit).

1-4 BS-240 Operator’s Manual


1 System description 1.2 Hardware components

Automatic Disable the Automatically synchronize with an Internet time server


synchronization with option.
Internet time server
Automatic updates Turn off the automatic updates.
Auto awake and If you are going to use the auto awake/shutdown function, perform
shutdown setup necessary settings for BIOS and network adapters while referring
to their operation manuals.
Sound card and speaker The system must be configured with sound card and speaker.

Recommended printer configuration


You are suggested to choose one of the following printers for use with the computer:
 Ink jet printer
 Laser printer (black and white)
 Stylus printer

1.1.2 Installation Procedure

WARNING
The system should be installed only by technicians of or authorized by our company.

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.

1.2 Hardware components


1.2.1 Overview
The analyzer consists of the following components:
 Analyzing unit (analyzer)
 Operation unit (computer)
 Output unit (printer)
 Accessories and consumables

BS-240 Operator’s Manual 1-5


1.2 Hardware components 1 System description

Figure 1.3 BS-240 chemistry analyzer

(1) (2) (3)

(1) Analyzing unit (2) Operation unit


(3) Output unit
Analyzing unit
The analyzer, determines various clinical chemistries in samples and generates test results. It is
composed of the following components:
 Sample/Reagent handling system
 Mixer assembly
 Reaction system
 Cuvette wash station
 Photometric system
 ISE unit (optional)
Operation unit
A computer with the operating software installed to perform test requisition, measurement,
reaction process monitoring, result calculation, and input, storing and query of test data.
Output unit
A printer for printing out test results and other data.
Accessories and consumables
Includes cuvette, lamp, concentrated wash solution (CD80), and other accessories and
consumables required by test.

1.2.2 Sample/Reagent handling system


The sample/reagent handling system holds sample and reagent and provides them for analysis.
It consists of the following assemblies:
 Sample/Reagent carousel assembly

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 Built-in bar code reader (optional)


 Dispenser assembly
 Probe wash assembly

Sample/Reagent carousel assembly


The sample/reagent carousel is a turntable located on the left side of the analyzer panel. It holds
sample tubes and reagent bottles and carries each of them to the aspirate position for
aspirating.
Figure 1.4 Sample/Reagent carousel assembly
(1) (2) (3)

(4)

(5)

(1) ISE sample injection port (2) Aspirate port on inner ring
(3) Aspirate port on middle ring (4) Aspirate port on outer ring
(5) Sample/Reagent carousel
Carousel positions
The carousel holds both sample and reagent, and it includes the outer ring, middle ring and
inner ring. The three rings provides the following positions:
 Outer ring: No.1-40, can hold 40 samples.
 Middle ring: No.1-40, can hold forty 20 mL reagent bottles, or 40 sample tubes with adapter.
 Inner ring: No.41-80, can hold forty 20 mL reagent bottles, or forty 40 mL reagent bottles
after merged with the middle ring.
The following fixed positions are provided for special reagents:
 W for physiological saline
 D for probe wash solution
 D1 for ISE wash solution
 User-defined position for pretreatment reagent
Reagent refrigeration
The sample/reagent carousel provides a refrigerating environment which is constant within
2°C-12°C for 24 hours a day. The reagents stored in such environment can be kept stable with
little volatilization.

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CAUTION
Every day before analysis, remove the plugs on the sample/reagent carousel in order to prevent mechanical
reset failure and bending the reagent probe. Restore the plugs after finishing tests of the day.
Ensure that the sample/reagent carousel is closed while the system is running tests. Opening the carousel
cover during test could result in probe collision or other failures.

NOTE
The refrigeration unit is powered independently from the analyzing unit, and it is operational once the MAIN
POWER is put to the ON position.
Installing/Removing the sample/reagent carousel

WARNING
Before installing or removing the sample/reagent carousel, make sure that the analyzer is in standby status or
is shut down, and the sample/reagent carousel has stopped.

BIOHAZARD
Wear gloves and lab coat and, if necessary, goggles.

Figure 1.5 Sample/Reagent carousel

(1)

(1) Handle

Installing the sample/reagent carousel


1 Lift the handle to make it vertical.
2 Align the hole on the hand wheel to the pin on the rotor, and then gently lay the
sample/reagent carousel.
3 Move the handle back to the horizontal position to secure the carousel to the rotor.
Removing the sample/reagent carousel
1 Lift the handle to make it vertical.
2 Hold the handle or the hand wheel to take out the sample/reagent carousel.

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CAUTION
Make sure the carousel cover is closed; otherwise the refrigeration performance could be degraded and the
probe could be damaged.
Before system operation, make sure that the carousel cover is closed properly; otherwise the probe could be
damaged.
The sample/reagent compartment and the carousel could be contaminated during measurement. If sample or
reagent spills in the compartment or on the carousel, switch off the analyzing unit power, and wipe them with
cloth soaked with water or disinfector.
Sample containers
Sample containers are used to hold sample.
Different sample tubes require different minimum sample volumes. Each sample tube must
contain the amount of sample 8mm higher than the unreachable sample level; otherwise, correct
aspirating cannot be ensured.
Table 1.2 Specification of sample containers
Sample Container Specification
Microtube Φ14×25 mm, 0.5 mL
Φ14×25 mm, 2 mL
Φ12×37 mm, 2 mL
Primary tube or plastic Φ12×68.5 mm
tube Φ12×99 mm
Φ12.7×75 mm
Φ12.7×100 mm
Φ13×75 mm
Φ13×95 mm
Φ13×100 mm

For the tests of the whole blood(centrifuged),onlyΦ12×68.5 mm, Φ12×99 mm, Φ12.7×75 mm,
Φ12.7×100 mm, Φ13×75 mm, Φ13×95 mm, Φ13×100 mm anticoagulation tubes can be used.
The sample height in the tube should be no higher than 55mm and the blood cell level should be
no lower than 10mm. Microcups are not allowed. To ensure the clinical performance and avoid
the system alarm, EDTA anticoagulation tubes are recommended.
Reagent bottles
20mL and 40mL reagent bottles are used.
Loading/Unloading sample tube

WARNING
Before installing or removing a sample tube, make sure that the sample/reagent carousel and the probe have
stopped.
Do not use sample tubes other than the specified ones.

BIOHAZARD
Wear gloves and lab coat and, if necessary, goggles.

To load a sample tube, insert it into the tube holder until the tube bottom contacts the groove of
the tube rack.

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To unload a sample tube, grab it and pull it upwards to remove from the tube holder.
Loading/Unloading reagent bottle

WARNING
Before installing or removing a reagent bottle, make sure that the sample/reagent carousel and the probe have
stopped.
Do not use reagent bottles other than the specified.
Some reagents may hurt human skins. Exercise caution when using the reagents. In case your skin or clothes
contact them, wash them off with clean water. In case the reagents spill into your eyes, rinse them with much
water and consult an oculist.

To load a reagent bottle, insert it into the bottle holder until the bottle bottom contacts the groove
of the holder.
To remove a reagent bottle, grab it and pull it upwards to remove from the bottle holder.

Built-in bar code reader (optional)


The bar code reader is provided for optional configuration. It is located on the upper-left corner
of the sample/reagent carousel, and used to scan the bar code on sample tube and reagent
bottle.
Figure 1.6 Bar code scanning window

(1)

(1) Bar code scanning window

WARNING
The light radiated from the sample bar code reader may hurt your eyes. Do not stare into the laser beam
coming from the bar code reader.

The table below lists the specifications of the bar code reader:
Table 1.3 Specifications of the bar code reader
Symbology Codabar, ITF, Code128, Code39, UPC/EAN, and Code93
Minimum bar code 0.19 mm - 0.50 mm
density
Length Sample bar code: 3-27 digits
Reagent bar code: 13-30 digits
Format and content User-defined
Maximum width 55mm

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Minimum height Sample bar code: 10 mm


Reagent bar code: 12 mm
Maximum inclination ±5°
angle
Print quality No less than Class C according to the ANSI MH10.8M Print Quality
Specification.
Width and narrowness Sample bar code: (2.5-3.0):1
Reagent bar code: 2.5:1
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.
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.

Dispenser assembly
The dispenser assembly located at the upper-right corner of the sample/reagent carousel is
composed of the probe, probe arm, probe rotor, syringe, wash well, and related fluidic path. It
aspirates the specified amount of sample and reagent from a sample tube and a reagent bottle
and then dispenses them into a cuvette for reaction.
Figure 1.7 Dispenser assembly

(1)

(2)

(4)

(3)

(1) Probe arm (2) Probe rotor


(3) Probe wash well (4) Probe

WARNING
When the system is in operation, do not place any part of your body or any obstacle in the route where the
sample probe arm moves; otherwise, personal injury or equipment damage may be caused.
Probe
One probe is available to add sample and reagent with the following volume range:
 Biochemistry: 2-45 μL, with increment of 0.1 μL.
 ISE test: 70 μL for serum and plasma, and 140 μL for diluted urine.
 Reagent: 10-250 μL, with increment of 0.5 μL.

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1.2 Hardware components 1 System description

Besides adding sample and reagent, the probe has the following functions:
 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 and tracking: Detects the liquid level in sample tube and reagent bottle and
determines the depth of lowering down into the liquid based on the specified aspirate
volume.

Probe wash assembly


The probe wash assembly consists of the wash well and related fluidic path. It is responsible for
cleaning the probe interior and exterior after the probe adds sample or reagent.

1.2.3 Mixer assembly


The mixer assembly, located on the lower-left side of the reaction carousel, is composed of the
mixer, mixer arm, and drive assembly. It stirs the reaction liquid in cuvettes once sample and
reagent are added.
Figure 1.8 Mixer assembly

(1) (4)

(3)

(2)

(1) Mixer rotor (2) Mixer wash well


(3) Mixer (4) Mixer arm

When stirring is finished, the mixer moves automatically to the wash well for cleaning.

1.2.4 Reaction system


The reaction system consists of the reaction carousel, cuvettes and drive assembly. It holds the
reaction cuvettes and carries them to the specified position for washing, adding reagent and
sample, mixing, reaction, and absorbance measuring.

Reaction carousel
The reaction carousel is a single-ring turntable, which can hold 8 cuvette segments. Each cuvette
segment includes 5 cuvettes.
The reaction carousel is heated by means of air bath to provide a constant environment at
37±0.3°C with fluctuation of ±0.1°C.

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Figure 1.9 Reaction carousel

(1)

(5)
(2)

(3)

(4)

(1) R1 dispense position (2) Sample and R2 dispense position


(3) Mixing position (4) Cuvette replacement window
(5) Reaction carousel

Reaction cuvette
Plastic reaction cuvette segments are used. Each segment includes 5 cuvettes (5 mm × 5 mm).
The light path length of the cuvette is 5 mm, and the internal dimension is 5 mm (length) × 5
mm (depth) × 29.5 mm (height).
The cuvettes used on the BS-240 can be washed automatically and should be replaced every 3
months.

1.2.5 Cuvette wash station


The BS-240 provides the 8-phase cuvette auto wash function, through which the cuvettes are
washed twice via four wash probes when a test is finished.
The cuvette wash station consists of the wash probes, elevating motor and related fluidic path.
The wash probes driven by the elevating motor to go up and down during each wash phase
dispense and aspirate wash solution in the cuvettes to finish washing.

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1.2 Hardware components 1 System description

Figure 1.10 Cuvette wash station

(3)

(1) (2)

(1) Phase-4 wipe block (2) Phase 1-3 wash probes


(3) Wash tubes

The cuvette wash station performs 8-phase wash on cuvettes by using diluted CD80 wash
solution and deionized water, so that the cuvettes can be contamination free and dry during the
test process.
After wash, the liquid waste is discharged in two flows: high-concentration waste and
low-concentration waste. The system provides level detection of high-concentration waste.
When the high-concentration waste exceeds the specified volume, the system gives an alarm to
reminds you to empty the high-concentration waste tank.
 For drainage requirements of high-/low-concentration waste, see Water supply and drainage on
page 1-3.

1.2.6 Photometric system


The photometric system located inside the analyzing unit measures absorbance of the reaction
mixture in cuvettes. It comprises the light source, filter, lens, and other components.

1.2.7 ISE unit (optional)

WARNING
The ISE unit must be operated by skilled/trained doctors, nurses or clinical professionals.
Exercise caution while using the ISE unit Prevent your hair, legs or other parts of your body from being hurt by
the driving parts.

The ISE (Ion Selective Electrode) unit consists of the ISE module, the pump module and the
reagent module, and can measure the concentration of Na+, K+ and Cl- ions in serum, plasma
and diluted urine.
If not specifically noted, "ISE module" represents the ISE unit.

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1 System description 1.2 Hardware components

Figure 1.11 ISE system

(3)

(1)
(2)

(1) Reagent module (2) Pump module


(3) ISE module

In ISE test, 70 μL serum or plasma, or 140 μL diluted urine (diluted at the ratio of 1:10) is
required.
The following components are comprised in the ISE unit:
 ISE module: includes the spacer, Na, K, Cl, and reference electrodes.
 Reagent module: includes the calibrator A, calibrator B, waste container, and chip for
measuring reagent volume.
 Pump module: includes the calibrator A pump, calibrator B pump and waste pump.

1.2.8 Operation unit


The operation unit is a computer configured with the operating software. It consists of the
monitor, computer, keyboard, and mouse.
Figure 1.12 Operation unit

(1)

(2)
(3)

(4)

(1) Display monitor (2) Mouse


(3) Keyboard (4) Computer
 For more information on the operation unit, see its operation manual.

1.2.9 Output unit


The output unit is a printer used to print out test results and other data. The system supports
three types of printer: inkjet printer, laser printer (black and white) and stylus printer.

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1.2 Hardware components 1 System description

Figure 1.13 Output unit

(1)

(1) Printer

You should purchase an appropriate printer compatible with the analyzer.


 For more information on the printer, see its operation manual.

1.2.10 Accessories and consumables


Accessories are necessary components for the instrument to perform sample analysis, and they
should be replaced regularly. Consumables are replenishable materials to be replaced after each
use, or vulnerable materials that should be replaced on a regular basis.
Please use the accessories and consumables manufactured or recommended by our company in
order to achieve the promised system performance. The Accessories and consumables list is
subject to change; if needed, contact our customer service department or your local distributor.
Table 1.4 Accessories and consumables
No Part Name Remark
1 Needle .0.25+/-0.01mm*125mm round head Accessory
2 Valve Washer,10-32,18011Telfon washer Accessory
3 20ml reagent bottle brown Accessory
4 40ml reagent bottle brown Accessory
5 20ml reagent bottle Accessory
6 Reagent bottle label Accessory
7 BS200 white cap of reagent bottle Accessory
8 BS200 red cap of reagent bottle Accessory
9 Accessory kit bar code Accessory
10 Parameter list Accessory
11 Cross screwdriver 102*100 Accessory
12 Serial port cable Accessory
13 Cuvette (Surface processed) Accessory
14 10L water tank Accessory
15 Water tank Accessory
16 Filter Accessory
17 Tube Φ9.525XΦ15.875 PVC 55~60 degree Accessory
18 BA24 Accessory
Operating Software Installation CD
19 Plug Accessory
20 Cable strap CHS-3X100mm Nylon Accessory
21 Mixer wrench Accessory
22 Tube.3.2*6.4mm TPU(Polyether)tube Accessory
23 Reference electrode Consumable
24 K electrode Consumable

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1 System description 1.3 Software description

No Part Name Remark


25 Na electrode Consumable
26 Spacer Consumable
27 ISE wash solution Consumable
28 Urine diluent Consumable
29 MEDICA control (Level 3) Consumable
30 Urine diluent (125ml) Consumable
31 ISE reagent pack Consumable
32 ISE Cl electrode (Turkey) Consumable
33 ISE reference electrode (Turkey) Consumable
34 ISE K electrode(Turkey) Consumable
35 ISE Na electrode (Turkey) Consumable
36 ISE spacer (Turkey) Consumable
37 ISE wash solution (Turkey) Consumable
38 ISE urine diluent(Turkey) Consumable
39 MEDICA control Level 3(Turkey) Consumable
40 ISE reagent pack (Turkey) Consumable
41 ISE reagent pack (5425)with package Consumable
42 Cl electrode 5207 Consumable
43 ISE Accessory kit with package Consumable
44 ISE Accessory kit (OEM with package) Consumable
45 CD80(international 6 bottles) Consumable
46 CD80(international 1L*1 bottle) Consumable
47 Plastic cuvette (8 pcs) Consumable
48 Three-core power cord international standard 10A 250V 1.6m Consumable
49 Power cord Europe standard (International) Consumable
50 Power cord US standard 1.5M15A Consumable
51 Power cord UK standard Consumable
52 1.8mPower cord India H05VV-F3X1.5mmVolex Consumable
53 Power cord Australia V-75 3×1.0 PVC Consumable
54 Power cord Brazil 250V 10A 3M Consumable
55 Sample tube adapter(5pcs) Consumable

1.3 Software description


1.3.1 Screen areas
The software screen is divided into the following areas:

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1.3 Software description 1 System description

Figure 1.14 Screen areas


(1) (2)

(5) (3)

(4)

(1) Status display area (2) Shortcut icons area


(3) Function window (4) Prompt message area
(5) Function buttons area

Status display area


The status display area shows the system status, including: biochemistry/ISE system status, test
time left, countdown for pausing, LIS connection, printer, login user, and system date/time.
If not especially stated, "non-test status" in this manual refers to Incubation, Standby and
Stopped; while "test status" refers to other statuses.

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Table 1.5 Status display area


Status indicator Description
Biochemistry/ISE This indicator appears on the left of the status display area. If an
ISE module is installed, the ISE status appears.
The status of the biochemistry system includes: Initialize,
Incubation, Standby, Running, Pause, Stopped, Maintenance,
Sample load, Reagent load, cuvette load, inventory check, restore
and Shutdown.
The status of the ISE module includes: Initialize, Standby, Running,
Stopped, Maintenance, and Shutdown.
Test time left This indicator appears in the middle of the status display area. It
indicates the minutes left that the analysis will be finished.
Countdown for pausing This indicator appears on the right of the status display area. It
indicates the minutes left that the dispensing of sample or reagent
will be stopped.
LIS connection status
This indicator appears on the left of the status display area. The
following information is indicated:

 If the icon appears in blue, the LIS host is connected and


online.

 If the icon appears in grey, the LIS host is offline.


Printer connection 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 printing 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.
Date and time This indicator appears on the right of the status display area. It
indicates the system date and time.

Shortcut icons area


The shortcut icons 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 window, on which you are
allowed to start new analysis or resume testing.

 : Pause icon. Select it to stop dispensing of sample and reagent. Then you are
allowed to load new samples or reagents on the sample/reagent carousel. To resume

the test, select .

 : Emergency stop icon. Select it to stop all tests and other actions. To restore the
system into Standby status, execute the Home command.

 : STAT icon. Select it to display the STAT Sample Program window, on which you
are enabled to program emergency samples quickly.

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1.3 Software description 1 System description

 : Online help icon. Select it to display the online help of the current window,
where you can find description of parameters and operations.

Function window
It displays the page or window related to the selected function button or shortcut icon. It is used
to perform system operations.

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 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
carousel status.

 : used to recall test results of patient samples and controls and view the result
statistics and test statistics.

 : used to set reagents, define/edit calibrators, request calibrations, recall


calibration results, and view reagent carousel status.

 : used to define/edit controls and QC rules, recall QC results and summary.

 : used to execute instrument commands, set up chemistry and system


parameters, perform system maintenance, and view component status.

 : used to recall and handle error logs and editing logs.

 : used to log off or shut down the system.

1.3.2 Screen elements


Page
A page appears when a tab is selected. The figure below is an example of page:

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1 System description 1.3 Software description

Figure 1.15 Example of page

Page

Window
A window has visible boundaries, which consists of title bar, content area and buttons.
The figure below is an example of window:
Figure 1.16 Example of window

Window

Tab
Click a tab to access the working page that it indexes.
The figure below is an example of tab:
Figure 1.17 Example of tab

Tabs

Drop-down list

Click to display a list and choose desired item in the list.


The figure below is an example of drop-down list:

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1.3 Software description 1 System description

Figure 1.18 Example of drop-down list

Drop-down list

Combo box
A combo box includes a field and a drop-down list, in which you can manually input characters
or select an option.
The figure below is an example of combo box:
Figure 1.19 Example of combo box

Combo box

Edit box
An edit box is a field in which you can input characters manually.
The figure below is an example of edit box:
Figure 1.20 Example of edit box

Edit box

Radio button
A radio button is a circle with text beside. It indicates a set of choices from which only one can
be selected.
The figure below is an example of radio button:
Figure 1.21 Example of radio button

Radio button

Check box
A check box is a square box with text beside. It indicates a set of choices from which one or
more can be selected.
The figure below is an example of check box:

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Figure 1.22 Example of check box

Check box

Button
A button is used to open a window or to execute a defined function.
The figure below is an example of button:
Figure 1.23 Example of button

Button

Scroll bar
A scroll bar is used to display the hidden contents when they are too many to be shown on one
screen. A vertical scroll bar moves the screen up and down, and a horizontal scroll bar moves
the screen left and right.
The figure below is an example of scroll bar:
Figure 1.24 Example of scroll bar

Vertical scroll bar

Horizontal scroll bar

List
A list holds multiple chemistries or panels, or contains texts or charts in the form of table.
The figure below is an example of list:

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1.3 Software description 1 System description

Figure 1.25 Example of list

List

Slider
A slider is used to select a scale continuously. Click and hold the slider and drag it to the desired
scale.
The figure below is an example of slider:
Figure 1.26 Example of slider

Slider

1.3.3 Software hierarchy


The figure below shows the menu structure of the operating software. By clicking a function
button, or a shortcut icon can access the relevant window.

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