Page 1
Automated Blood Coagulation Analyzer
CS-2500
Instructions for Use
Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed
healthcare professional.
CHAPTER 1 Introduction
CHAPTER 2 Principles of Operation
CHAPTER 3 Performance Characteristics and Specifications, Reagents
CHAPTER 4 Operating Instructions
CHAPTER 5 Creating Calibration Curves
CHAPTER 6 Operational Precautions and Limitations/Hazards
CHAPTER 7 Maintenance
CHAPTER 8 Troubleshooting
CHAPTER 9 General Information
Index
KOBE, JAPAN
Code No. BH809763
SMN: 11239441
Date of Last Revision: March 2020
Software Version: 01-70 onwards© SYSMEX CORPORATION 2015-2020
Page 2
Page 3
Table of Contents
Chapter 1 Introduction 1-1
1.1 Common name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3 Symbols used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.4 Design and function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.5 Product information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
1.6 Technical information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Chapter 2 Principles of Operation 2-1
2.1 System overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Assay parameters (analysis parameters and calculated parameters) . . . . . . . 2-2
2.3 Analysis overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.4 Basic operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.5 Analysis principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
2.6 Basic actions of the instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
2.7 Preparing for analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
2.8 Performing analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-78
2.9 Checking analysis results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-127
2.10 Performing QC analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-168
Table of Contents
Chapter 3 Performance Characteristics and
Specifications, Reagents 3-1
Chapter 4 Operating Instructions 4-1
4.1 Setting up the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 User administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
4.3 Registering the reagent master . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-45
4.4 Registering the reagent lot master . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-54
4.5 Setting up assay groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-60
4.6 Setting up the formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-124
4.7 Customizing screen displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-135
4.8 Frequently asked questions (FAQs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-172
4.9 Utility tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-174
Chapter 5 Creating Calibration Curves 5-1
5.1 Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Creating calibration curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.3 Loading assay sheet values, normal values and ISI values
from the barcode on the assay value sheet . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
5.4 Confirming calibration curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
5.5 Validating calibration curves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
5.6 Calibration curve calculation specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
5.7 Editing calibration curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
5.8 Printing calibration curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
5.9 Deleting calibration curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
5.10 Restoring old calibration curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
CS-2500 Instructions for Use
I
Revised March 2020
Page 4
Table of Contents
Chapter 6 Operational Precautions and
Limitations/Hazards 6-1
6.1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Warning/caution/risk of infection labels on the instrument . . . . . . . . . . . . . . . . 6-9
6.3 Symbols used on the labels for consumables . . . . . . . . . . . . . . . . . . . . . . . . 6-17
6.4 Limitations (INR/ISI cautionary statement) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Chapter 7 Maintenance 7-1
7.1 Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Maintenance checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.3 [Status Display] screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7.4 [Maintenance] screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.5 Daily maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
7.6 Weekly maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
7.7 Monthly maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27
7.8 As-needed maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29
7.9 Confirming the unit and parts cycle counts . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-47
7.10 Replacing supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-48
7.11 Supplies list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-56
7.12 Checking the operation log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-59
Chapter 8 Troubleshooting 8-1
8.1 Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 When you suspect an error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.3 When an error is displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.4 Checking the error log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
8.5 Error message list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
8.6 Testing barcode reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-50
Chapter 9 General Information 9-1
9.1 Name and place of business of manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2 GNU General Public License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.3 Trademarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Index
II
CS-2500 Instructions for Use
Revised March 2020
Page 5
Chapter 1 Introduction
Note:
Chapter 1 Introduction
Thank you for purchasing this Sysmex CS-2500 automated blood coagulation analyzer.
Please read this manual carefully before operating this product.
Keep this manual in a safe place for future reference.
• Data generated by CS-2500 is not intended to replace professional judgment in the
determination of a diagnosis or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there
are any deviations from the instructions in this manual. If the instrument fails to function
properly as a result of either the user’s operation not specified in this manual or the user’s
utilization of a program not specified by Sysmex, the product warranty would not apply.
• To avoid potential troubles or damages, Sysmex recommends to use authentic cuvettes or
other consumables supplied by Sysmex and avoid using counterfeit or recycled cuvettes or
consumables supplied by unauthorized others. Please be advised that Sysmex is not
responsible for any troubles or damages or any inaccurate test results caused by the use of
counterfeit or recycled cuvettes or consumables supplied by unauthorized others.
• Please note that the cuvettes for CS series (SUC-400A) are protected by Japanese Patent No.
4,018,131, Chinese Patent No. ZL200680027159.6 and United States Patent No. 7,787,116.
At least in the jurisdictions in which these patents are valid, patent rights cover not only
manufacture and sale of patented goods but also their use (Art. 2 and 68, Patent Law in
Japan; Art. 11, Patent Law in China; Art. 271, United States Patent Law). Therefore, if you
purchase and use in one of the jurisdictions where a valid patent exists cuvettes for CS series
that infringe the aforementioned patents from an unauthorized supplier, you may be held liable
as well for infringing these patents.
• Assay protocol settings have been verified and guarantee data performance by Sysmex and
Siemens. Please contact Sysmex or its distributors for any modification of assay protocol
setting or creation of new assay protocol.
1.1 Common name
Automated Blood Coagulation Analyzer
CS-2500 Instructions for Use
1-1
Revised March 2020
Page 6
Chapter 1 Introduction
Information
1.2 Intended use
The Sysmex Automated Blood Coagulation Analyzer CS-2500 is a fully automated blood coagulation analyzer
intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2 % sodium citrate tubes
to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory.
For determination of:
• Prothrombin Time (PT) seconds and PT INR with Thromborel S
• Prothrombin Time (PT) seconds and PT INR with Dade Innovin
• Activated Partial Thromboplastin Time (APTT) with Dade Actin FS
• Activated Partial Thromboplastin Time (APTT) with Dade Actin FSL
• Fibrinogen (Fbg) with Dade Thrombin Reagent
• Thrombin Time with Test Thrombin Reagent
• BatroxobinTime with Batroxobin Reagent
• Coagulation Factor II with Dade Innovin
• Coagulation Factor V with Dade Innovin
• Coagulation Factor VII with Dade Innovin
• Coagulation Factor X with Dade Innovin
• Coagulation Factor VIII with Dade Actin FS
• Coagulation Factor VIII with Dade Actin FSL
• Coagulation Factor IX with Dade Actin FS
• Coagulation Factor IX with Dade Actin FSL
• Coagulation Factor XI with Dade Actin FS
• Coagulation Factor XI with Dade Actin FSL
• Coagulation Factor XII with Dade Actin FS
• Coagulation Factor XII with Dade Actin FSL
• Lupus Anticoagulant with LA1 Screening and LA2 Confirmation Reagent
•Factor V Leiden with Factor V Leiden Assay
• Protein C with Protein C Reagent
• Antithrombin (AT) with INNOVANCE Antithrombin
• Heparin with INNOVANCE Heparin
• Protein C with Berichrom Protein C
• α2-Antiplasmin with Berichrom α2-Antiplasmin
• Plasminogen with Berichrom Plasminogen
• Coagulation Factor VIII with Factor VIII Chromogenic Assay
• D-dimer with INNOVANCE D-Dimer
• Free Protein S with INNOVANCE Free PS Ag
The performance of this device has not been established in neonate and pediatric patient populations.
1-2
The performance of this device has not been established in neonate and pediatric patient
populations. Test results obtained from pediatric patient populations may be age dependent.
Therefore, each laboratory must follow their regulatory agency guidelines to qualify additional
age groups.
CS-2500 Instructions for Use
Revised March 2020
Page 7
Chapter 1 Introduction
Risk of infection
Warning!
Caution!
Caution, Hot!
Caution, Electric!
Information
Note:
1.3 Symbols used in this manual
Note, Information, Caution and Warning statements are presented throughout this manual to call attention to
important safety and operational information. Non-compliance with this information compromises the safety features
incorporated in the analyzer.
This symbol indicates a possible hazardous situation which, if not avoided, may result in
infection by pathogens and others.
High risk. Ignoring this warning could result in personal injury to the operator.
Average risk. Ignoring this warning could result in property damage or incorrect analysis results.
Indicates a potential risk of burns or other physical damage in the event of incorrect operation or
failure to observe the content.
Failure to comply with this warning may lead to sensor damage from static electricity.
Minor risk. Considerations that should be observed when operating this instrument.
Background information and practical tips.
CS-2500 Instructions for Use
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Revised March 2020
Page 8
Chapter 1 Introduction
Warning!
Caution!
1.4 Design and function
1.4.1 Main Unit
Do not reach into the inside of the instrument during analysis.
Doing so may result in injury.
• Do not open the STAT/buffer table cover if the STAT/buffer table cover LED is flashing green.
This could cause instrument failure.
• Do not open the reagent table cover during analysis when the reagent table cover LED is
flashing green. Also, do not open the dispensing table cover when the dispensing table cover
LED is flashing green.
This could cause instrument failure.
• Do not turn the power ON and OFF repeatedly in a short period of time.
1-4
CS-2500 Instructions for Use
Revised March 2020
Page 9
Front view
Warning!
Warning!
(1)
(2)
(5)
(7)
(6)
(8)
(4)(3)
(1) Light shield lid
Open this cover to set reagents, perform maintenance, etc.
Chapter 1 Introduction
When reaching into the inside of the instrument with the light shield lid open, always check that
the light shield lid is fully open. If it is not, the light shield lid could fall down, injuring the user’s
head or elsewhere.
When closing the light shield lid, take care not to pinch your fingers.
(2) Sampler
Automatically transports samples that are set in the sample rack to the aspiration position.
(3) Reagent section lid
Open this cover to set reagents.
• When reaching into the inside of the instrument with the reagent section lid open, always
check that the lid is fully open. If it is not, the reagent section lid could fall down, injuring the
user’s head or elsewhere.
• When closing the reagent section lid, take care not to pinch your fingers.
CS-2500 Instructions for Use
Revised March 2020
1-5
Page 10
Chapter 1 Introduction
Warning!
*1: Long flashing red turns to solid red when the alarm is stopped.
Color Status
Green • Ready to start analysis.
• Analysis has been interrupted by interruption to operation.
Flashing green • Warming up.
• Analyzing.
Orange • Analysis can be started but consumables are used up.
• Analysis has been interrupted and consumables are used up.
Flashing orange Analysis is being performed and consumables are used up.
Red • Analysis has been automatically stopped by the instrument.
• Analysis cannot be started due to an error.
Long flashing red
*1
(4) Cuvette hopper
Cuvettes placed here are automatically supplied to the interior of the instrument.
When closing the cuvette hopper cover, take care not to pinch your fingers.
(5) Alarm indicator LED
Indicates the instrument status.
(6) Mechanical stop switch
Press this switch to immediately stop the instrument’s mechanical movement.
(7) Start button
Press this button to immediately start an analysis.
This button is the same as the [Start] button on the IPU toolbar.
(8) Cuvette trash box
Used cuvettes are discarded here.
The Trash Box Liner CS2 can be set in the box.
1-6
CS-2500 Instructions for Use
Revised March 2020
Page 11
Main Unit interior (right side)
(7)
(9)
(8)
(12)
(1)
(4)
(5) (6)
(2)
(13)
(15)
(16)
(17)
(18)
(19)
(20)
(14)
(10)
(11)
(3)
Chapter 1 Introduction
(1) Sample arm
(2) Sample probe
Aspirates and dispenses samples, controls, calibrators and buffers.
(3) Reagent table cover C
If the instrument status display is [Ready], this can be opened to replenish or replace reagents.
(4) Dispensing table
Set cuvettes containing stir bars here.
(5) Incubator
Incubates a sample in the cuvette.
(6) Detector
Analyzes a sample in cuvettes.
(7) Detector catcher
Transfers cuvettes to the incubator well, to the detector well and to the dispensing table.
CS-2500 Instructions for Use
Revised March 2020
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Page 12
Chapter 1 Introduction
Risk of infection
Caution!
(8) Supply catcher
Transfers a cuvette to the dispensing table and the incubator.
(9) Cuvette feeder
Supplies cuvettes.
(10) STAT/buffer table cover
Open this to place STAT samples and buffer on the STAT/buffer table.
(11) STAT/buffer table cover LED
This LED indicates whether it is permissible to open the STAT/buffer table cover.
Green LED: Allowed to open the cover
Flashing green LED: Not allowed to open the cover
(12) STAT/buffer table
Set STAT samples and buffer here.
(13) Barcode reader (sampler)
Reads the barcode of samples set on the sampler.
(14) Lock lever
Locks and unlocks reagent table covers A and B.
(15) Reagent table cover B/reagent table B
Open reagent table cover B and set the reagent on reagent table B.
(16) Reagent table cover A/reagent table A
Open reagent table cover A and set the reagent on reagent table A.
(17) Dispensing table cover
Can be opened for placing the cuvettes containing stir bars on the dispensing table.
(18) Reagent table cover (B) LED
Indicates whether it is permissible to open reagent table cover B.
Green LED: Allowed to open the cover
Flashing green LED: Not allowed to open the cover
(19) Reagent table cover (A) LED
Indicates whether it is permissible to open reagent table cover A.
Green LED: Allowed to open the cover
Flashing green LED: Not allowed to open the cover
(20) Dispensing table cover LED
This LED indicates whether it is permissible to open the dispensing table cover.
Green LED: Allowed to open the cover
Flashing green LED: Not allowed to open the cover
Never touch the tip of the probe.
The probe tip is sharp and very dangerous. Handle it with care.
Accidentally touching the probe tip could cause injury and infection with pathogens.
Do not slide the lock levers of the table covers when the reagent table A cover LED and the
reagent table B cover LED are flashing green. If the lock handles are moved from their lock
positions, the alarm will sound. Replace the lock levers to their original positions. Otherwise, the
instrument will stop analysis.
1-8
CS-2500 Instructions for Use
Revised March 2020
Page 13
Front Interior (left side)
(3)
(1)
(4)
(5)
(6)
(2)
(7)
Chapter 1 Introduction
(1) Reagent arm
(2) Reagent probe
Aspirates reagent and adds it to the sample.
(3) 0.10 MPa adjustment knob
Used to adjust the positive pressure (0.10 MPa).
(4) –0.067 MPa adjustment knob
Used to adjust the vacuum pressure (–0.067 MPa).
(5) Trap chamber
Prevents reagents and other fluid from flowing into the Pneumatic Unit in the event of an instrument failure.
(6) CP mechanism
This is the mechanism for the cap piercer.
(7) Hopper
Supplies cuvettes.
CS-2500 Instructions for Use
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Revised March 2020
Page 14
Chapter 1 Introduction
(1)
(2)
Right side
(1) Exterior lamp cover
Open this cover to replace the lamp.
(2) IPU connector
Connects the IPU.
1-10
CS-2500 Instructions for Use
Revised March 2020
Page 15
Left side
(2)
(1)
(3)
(4) (5)
(6) (7)
(8) (9)
(10)
(11)
(12)
(13)
(14)
(1) Power connector
(2) Power switch
(3) Pressure adjustment area cover
(4) Nipple (D)
(5) Connector (D)
(6) Rinse aspiration nipple (Rns)
(7) Float sensor connector for rinse tank (Rns)
(8) Waste outlet nipple (W)
(9) Float sensor connector for waste tank (W)
(10) Pressure inlet nipple (P)
(11) Vacuum inlet nipple (V)
(12) Pneumatic Unit control connector
Chapter 1 Introduction
Insert the power cord into this power connector.
Turns the main power ON/OFF.
Open this cover to adjust the positive pressure (0.10 MPa) and vacuum (-0.067 MPa).
A spare nipple.
A spare connector.
Connected to the rinse tank.
Connected to the float switch for rinse.
Connected to the drain or waste tank.
Connected to the float switch for the waste tank.
Connected to the pressure outlet nipple (P) of the Pneumatic Unit.
Connected to the vacuum outlet nipple (V) of the Pneumatic Unit.
This is the output control connector for switching ON/OFF of the Pneumatic Unit. It is connected to the
Pneumatic Unit control input connector of the Pneumatic Unit.
CS-2500 Instructions for Use
Revised March 2020
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Page 16
Chapter 1 Introduction
(13) Overflow waste line nipple (reagent) (O)
Waste fluid overflowing during reagent probe cleaning, for example due to hydraulic system error, is
discharged via this nipple. It connects to the waste tank.
(14) Overflow waste line nipple (sample) (O)
Waste fluid overflowing during sample probe cleaning, for example due to hydraulic system error, is
discharged via this nipple. It connects to the waste tank.
1-12
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Page 17
1.4.2 IPU
Information
Note:
(4)
(2)
(3)
(1)
Chapter 1 Introduction
(1) Touch panel display
The IPU screen will appear. It can also be used as a touch panel.
(2) Main Unit
This is the Main Unit of IPU.
The IPU illustration shown is for reference only. Refer to the manual included with the computer
for the layout of connection ports and other details.
Please contact your local service representative for inspection.
(3) Keyboard
Used to operate the IPU, together with the touch panel.
(4) Mouse
Used to operate the IPU, together with the touch panel.
You can print out the analysis results by connecting the IPU to a printer.
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Revised March 2020
Page 18
Chapter 1 Introduction
Warning!
Caution!
(1)
(2)
Front view Rear view
(3)
(6)
(7)
(4)
(5)
1.4.3 Pneumatic Unit
The Pneumatic Unit supplies positive/vacuum pressure to the Main Unit.
(1) 0.22 MPa adjustment knob
Used to adjust 0.22 MPa (positive pressure) that is supplied to the Main Unit.
(2) Pilot lamp
Lights when the Pneumatic Unit power is ON.
(3) Pressure outlet nipple (P)
Used to supply pressure to the Main Unit. Connected to the pressure inlet nipple (P) of the Main Unit.
(4) Vacuum outlet nipple (V)
Vacuum is supplied to the Main Unit through this nipple. Connected to the vacuum inlet nipple (V) of the
Main Unit.
(5) Pneumatic Unit control input connector
Used as the input connector for turning Pneumatic Unit power ON and OFF. Connected to the Pneumatic
Unit control connector of the Main Unit.
(6) Fuse holder
Fuses are attached here.
Use a time-lag fuse for 250 V 4 A.
1-14
Before replacing the fuse, turn the power OFF and unplug the power cord.
This is necessary to avoid the risk of electric shock.
Use a fuse of the specified type and rating.
Otherwise, smoke or fire may result.
CS-2500 Instructions for Use
Revised March 2020
Page 19
(7) Power connector
Insert the power cord into this power connector.
1.4.4 Options
Options that can be used for this instrument are as follows:
(1) Waste tank (with float switch for waste tank)
Stores waste fluid from the Main Unit in the tank.
(2) 2D barcode reader
Reads barcodes to input calibrator or reagent assay sheet values, normal values and ISI values, control’s
targets/limits, sample numbers and rack numbers.
(3) Monitor arm
Holds the display.
(4) Pneumatic Unit cart
A dedicated cart for the Pneumatic Unit.
(5) Multi-touch compatible display
This is 21.5 inch, wide-screen LCD display, compatible with touch operation.
Chapter 1 Introduction
CS-2500 Instructions for Use
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Revised March 2020
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Chapter 1 Introduction
1.5 Product information
1.5.1 Specifications
Dimensions and weight Main Unit: approx. 775 (W) × approx. 895 (D) × approx. 685 (H) mm,
approx. 110 kg
Pneumatic Unit: approx. 280 (W) × approx. 355 (D) × approx. 400 (H) mm,
approx. 17 kg
* The above includes the Sampler Unit except the projections. The IPU and other
options are not included.
Electrical rating Voltage: Main Unit 100 – 240 V
Pneumatic Unit 100 – 117 V
Frequency: 50/60 Hz
Power consumption: Main Unit 800 VA or less.
Pneumatic Unit 100 – 117 V 280 VA or less
Heat compensation required (including Main Unit and Pneumatic Unit):
approx. 4,000 BTU/h (1,040 Kcal/h)
Installation category (excess voltage category): Category II
Laser class category: Class I (IEC60825-1:2007)
Protection type: Class I equipment
Operating environment Ambient temperature: 15 - 30 ºC
Relative humidity: 30 - 85 % (there must be no condensation other than on the
reagent table)
Atmospheric pressure: 70 - 106 kPa
Noise level 60 dB or below
Not including sudden noise which exceeds 60 dB and stops within 5 seconds, and
alarms.
Storage condition
(Transportation)
Detector 10 wells (of which 4 wells have a mixing function using stir bars)
Incubator 10 wells
Cuvette hopper Maximum approx. 500 cuvettes can be loaded in the hopper and supplied
Temperature control Detector: 37 ºC±0.5 ºC
Time taken to reach set
temperature
Display Graphical display on the touch panel display
Printout Graphic printing through an externally connected printer.
Safety standard IEC61010-1:2001, IEC61010-2-081:2001+A1:2003, IEC61010-2-101:2002
Ambient temperature: –10 - +60 ºC
Relative humidity: 30 - 95 %
Atmospheric pressure: 70 - 106 kPa
automatically
Sample incubator: 37 ºC±1.0 ºC
Reagent probe: 37.5 ºC±0.5 ºC
Within 30 minutes after turning the power ON (when room temperature is within the
ambient temperature range of the operating environment specification)
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Chapter 1 Introduction
1.5.2 Performance
Throughput PT single-parameter analysis: 180 tests/h (maximum)
PT/APTT simultaneous analysis: 180 tests/h (maximum)
Data storage capacity Maximum 10,000 samples
Number of
simultaneous analysis
parameters
Detection time Up to 1,800 sec. for each parameter
Analysis time (default) PT: 180 seconds
Time resolution Sampling can be performed for up to 1,800 seconds, at intervals of 0.1 seconds.
Quality control data A maximum of 750 files or up to 1,200 plots can be saved.
Calibration Curves Number of settable parameters: Maximum 250 parameters
Cooling of reagents The reagent holders (40 wells) are cooled using Peltier elements for temperature
Maximum 60 parameters
APTT: 180 seconds
Fbg: 100 seconds
Number of points: 2 - 12 points/calibration curve
Number of analyses: Maximum of 5 replications per point are possible
control.
10 ºC±2 ºC (ambient temperature of 20 ºC or above and below 28 ºC, while in
operation or during regular reagent table rotation)
4 - 15 ºC (ambient temperature between 15 - 20 ºC, or 28 - 30 ºC)
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Revised March 2020
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Chapter 1 Introduction
1.5.3 Required sample volume
• The sample volume which is actually required for analysis is the total required sample volume for the
parameters to be analyzed, plus the extra volume.
• Twice the required sample volume is necessary for performing replication analyses. The initial required
sample volume covers all the re-analysis conditions when performing automatic re-analysis.
• If the specified sample tube is not used, or if the sample volume is insufficient, air and/or blood cells may get
aspirated and correct analysis results may not be obtained.
• The extra volume for normal mode operation is as follows:
If sample aspiration volume is 270 µL or less 170 165
If sample aspiration volume exceeds 270 µL 210 200
* In normal mode, samples are first taken into the instrument, so up to an extra 210 µL is required for the
CS-2500.
• The maximum volume of sample that can be aspirated per analysis is as follows.
Maximum sample volume that can be aspirated per analysis (µL)
Capped sample tube Uncapped sample tube
330 340
* If the total required sample volume exceeds the maximum volume that can be aspirated per analysis, the
error message [Reduce the orders] is displayed in the [Error Help] dialog box. Reduce the number of
analysis parameters or analyses and perform analysis again.
However, it is also possible to perform analyses of samples within a range that can be analyzed with the
maximum aspiration volume, depending on the setting. See below for the setting method.
(➤ P.4-25 “Chapter 4: 4.1.7.14 [Sampling Mode] screen”)
Extra volume (µL)
Capped sample tube Uncapped sample tube
1-18
• The following is an example of the required sample volume that corresponds to the analysis conditions.
e.g. 1) When analyzing a centrifuged sample using capped standard sample tubes (inside
diameter of 9.4 mm)
* Analyze the 2 parameters PT and APTT in normal mode
Required sample volume for PT analysis 50 µL
Required sample volume for APTT analysis 50 µL
Extra volume in normal mode 170 µL
Extra volume to prevent incorrect blood cell aspiration 600 µL
Total 870 µL
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Chapter 1 Introduction
e.g. 2) When analyzing a centrifuged sample using capped BD (1.8 mL)
* Analyze the 3 parameters PT, APTT and Fbg in normal mode (set for automatic re-analysis)
Required sample volume for PT analysis 50 µL
Required sample volume for APTT analysis 50 µL
Required sample volume for Fbg analysis 10 µL (normal analysis) +
20 µL (Automatic re-analysis)=
30 µL
Extra volume in normal mode 220 µL (2 aspirations)
Extra volume to prevent incorrect blood cell aspiration 600 µL
Total 950 µL
e.g. 3) When analyzing a sample transferred to a sample cup (when the standard sample tube is
selected in the sample tube type option)
* Analyze the 2 parameters PT and APTT in micro-sample mode
Required sample volume for PT analysis 50 µL
Required sample volume for APTT analysis 50 µL
Extra volume to prevent air aspiration 300 µL
Total 400 µL
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Chapter 1 Introduction
Information
1.5.4 Usable sample tubes
This instrument can use sample tubes with the following dimensions:
• Inner diameter 8 mm or more
• Outer diameter of 10 - 15 mm
• Length 75 mm or less (when uncapped)
* Sample tubes whose inner diameter is less than 9.4 mm cannot be present on a rack together with other
types. Capped sample tubes and sample containers longer than 75mm cannot be set in the STAT sample
holder.
* See below for the details of sample tubes compatible with cap piercing.
(➤ P.1-21 “Chapter 1: 1.5.4: ● Details of sample tubes compatible with cap piercing”)
You can set the type of sample tube assigned to the desired sample rack. Up to 5 sample tube
types can be configured, with up to 5 rack numbers registered by each setting.
(➤ P.4-22 “Chapter 4: 4.1.7.11 [Rack Assignment] screen”)
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● Details of sample tubes compatible with cap piercing
Size
Manufacturer
Becton,
Dickinson
and
Company
Greiner
bio-one
Terumo
Kabe Primavette 2.9 φ11.5 66
SARSTEDT
AG & Co.
Corning Cryogenic Vial
: Sample tubes indicated by can be used as capped and uncapped tubes.
: Sample tubes indicated by can be used as uncapped tubes.
×: Cannot be used.
Product name
Vacutainer CTAD
(Hemogard
stopper)
*1
Vacutainer Plus
(Hemogard
stopper)
VACUETTE
MiniCollect
(with Na-Citrate)
MiniCollect
(without
Na-Citrate)
(Carrier Tube)
MiniCollect
Complete
(without
Na-Citrate)
Venosafe
Kabevette 2.9 φ12.372 ЧЧЧЧЧ
S-Monovette 4.3 φ13 75
S-Monovette
S-Monovette
Monovette
Tube
Sample
volume
*2
*2
*2
*2
*3
*2
Outer
(mL)
4.5 φ13 75
2.7 φ13 75
1.8 φ13 75
4 φ13 75
3 φ13 75 × × × × ×
3.5 φ13 75 × × × × ×
2 φ13 75
1 φ13 75
1 φ13 75 - -
1 φ13 75 - - × × ×××
3.6 φ13 75
2.7 φ13 75 ×
1.8 φ13 75 ×
2.9 φ12.465 ЧЧЧЧЧ
3 φ13 75 × × × × ×
1.4 φ866 × ××××
2.9 φ13 65 ×
3 φ11 66 *4 ×
1.8 φ11 75
3.5 φ12.5 66
4 φ10 60
diameter
(mm)
Length
(mm)
Sample
tube
adapter
Tube holder
No. 59,
adapter
No. 237,
238
Holder_ASSY
NO.298
Tube holder
No. 59,
adapter
No. 237,
238
(remaining unaspirated volume) (mL)
(mm display indicates the plasma depth)
Normal mode
Plasma
only
0.8
11 mm
0.5
12 mm
0.4
12 mm
0.5
12 mm
0.3
12 mm
0.9
11 mm
0.4
12 mm
0.4
12 mm
0.8
12 mm
0.7
12 mm
0.8
12 mm
Extra volume
With
blood
cell
layer
0.7
7.5 mm
0.5
7.5 mm
0.4
7.5 mm
0.5
7.5 mm
1.3
7.5 mm
0.8
7.5 mm
0.6
7.5 mm
0.35
7.5 mm
0.35
7.5 mm
1.5
7.5 mm
-
-
Micro-sample mode
only
0.5
0.3
0.2
0.3
0.2
0.4
0.2
0.2
0.8
0.3
0.3
With
blood
cell
layer
0.3
3.5 mm
0.3
4.5 mm
0.2
4.5 mm
0.3
4.5 mm
1.3
4.5 mm
0.8
4.5 mm
0.3
4.5 mm
0.3
3.5 mm
0.3
4.5 mm
0.3
4.5 mm
1.5
4.5 mm
Plasma
7 mm
7 mm
7 mm
7 mm
7 mm
7 mm
7 mm
7 mm
7 mm
7 mm
7 mm
Chapter 1 Introduction
*5
- ЧЧЧЧЧ
- ЧЧЧЧЧ
[System Settings] dialog box
[Sample Tube Type] settings
[Standard
[BD
*7, *11
[BD
2.7mL]
*8, *11
Sample
1.8mL]
*6
Tube]
×
×× × ×
× ××××
××× ×
×××× ×
×××× ×
×× ×××
×
ЧЧЧЧЧ
ЧЧЧЧЧ
ЧЧЧЧЧ
[VACUETTE]
*9, *11
[VACUETTE
Sandwich
Coagulation
*10, *11
Tube]
[MONOVETTE]
*11
*1: Please contact your local Becton Dickinson Preanalytical Solutions representative to order.
*2: If this sampling tube is used, do not perform four or more piercing operations whenever possible. Pressure
errors can prevent the predetermined volume from being aspirated, leading to incorrect results.
Before the fourth consecutive piercing, equalize the pressure in the tube by releasing and refitting the cap,
then perform analysis.
*3: A Carrier tube (Part No. 55.1571) is required as an adapter.
*4: When using S-Monovette sample tubes, ask your service representative or sales office about a dedicated
tube adapter.
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Chapter 1 Introduction
*5: Indicates the value when [Standard Sample Tube] is selected from [Sample Tube Type].
*6: In micro-sample mode, all sample tubes must have an inner diameter larger than 9.4 mm.
*7: Sample cups (4 mL) cannot be used.
In micro-sample mode, only 1.8 mL (Hemogard) Vacutainer Plus Plastic Citrate tubes can be used.
*8: In micro-sample mode, 2.7 mL (Hemogard) Vacutainer Plus Plastic Citrate tubes and sample tubes with an
inner diameter larger than 9.4 mm can be used.
*9: In micro-sample mode, VACUETTE tubes and sample tubes with an inner diameter larger than 9.4 mm can
be used.
*10: In micro-sample mode, VACUETTE Sandwich Coagulation tubes and sample tubes with an inner diameter
larger than 9.4 mm can be used.
*11: When used under this condition, approximately 0.1 mL will increase in extra volume stated.
* Tube holder No. 59 is preinstalled in sample racks. Replace it with the appropriate holder as necessary.
1.5.5 Usable reagent vials
The usable reagent vials and their extra volumes, are stated below.
There may be slight variation in the stated extra volume due to differences in reagent types and the state of the
reagent vial.
Reagent vials that can be used on reagent table and their extra volumes
Vial and capacity Extra volume (mL)
Reagent probe Piercer
Siemens reagent vial 5 mL (GW5) 0.3 (1.3) 1.1
Siemens reagent vial 15 mL (GW15) 0.4 (2.1) –
Siemens reagent vial 25 mL (GW25) 0.4 (2.1) –
Sample Cup 4 mL (Cup 4 mL) 0.2 0.5
SLD mini cup 1 mL (SLDmini) 0.1 0.15
* The values in the parentheses ( ) are those obtained by using stir bars.
* CA CLEAN I and II are used for cleaning the tip and interior of the probe. It is necessary to prepare an extra
volume to fill the reagent vial to a level of 10 mm. Prepare an extra volume equivalent to 10 mm for each vial
as shown below:
• Siemens reagent vial 15 mL (GW15): 7 mL
• CAClean vial 50 mL: 7 mL
* SLD mini cups cannot be used with any reagents other than controls and calibrators.
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Chapter 1 Introduction
Caution!
Reagent vials that can be used on buffer table and their extra volumes
Vial and capacity Extra volume (mL)
Sample probe Piercer
Siemens reagent vial 5 mL (GW5) 1.2 2.3
Siemens reagent vial 15 mL (GW15) 2.0 3.9
Siemens reagent vial 25 mL (GW25) 2.0 3.9
Sample Cup 4 mL (Cup 4 mL) 0.2 0.5
* The extra volume stated for a sample cup is the value when a sample cup 4 mL (Part No. 424-1160-8) is
used.
*CA CLEAN I and II are used for cleaning the tip and interior of the probe. It is necessary to prepare an extra
volume to fill the reagent vial to a level of 10 mm. Prepare an extra volume equivalent to 10 mm for each vial
as shown below:
• Siemens reagent vial 15 mL (GW15): 7 mL
• CAClean vial 50 mL: 7 mL
• Prepare a sufficient volume of reagent which takes into consideration the extra volume
required.
When the volume of the reagent is insufficient, the sample may not be analyzed accurately.
• Use only the 4 mL sample cup (Part No. 424-1160-8). If a different sample cup is used, the
reagent may not be aspirated correctly, resulting in incorrect analysis results.
CS-2500 Instructions for Use
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Revised March 2020
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Chapter 1 Introduction
Caution!
With a slit
Without a slit
1.5.6 Reagent vials and appropriate reagent caps/cover rings
The reagent caps/cover rings that are appropriate for individual reagent vials are shown below.
Use the correct reagent caps for reagent vials.
If the correct combination is not used, the reagent cannot be correctly aspirated because of a
probe crash and sampling error, and it may not be possible to obtain accurate analysis results.
Reagent vial Appropriate reagent cap Appropriate cover ring
Siemens reagent vial 5 mL (GW5) Reagent cap S CSS-400A
(Part No.AS143226)
40 mm
22 mm
Cap No.528 (Kit No.105)
(Part No.CC907148)
22 mm
Siemens reagent vial 15 mL
(GW15)
50 mm
30 mm
Reagent cap L CSL-400A
(Part No.AF504574)
Cap No.527 (Kit No.106)
(Part No.BB564291)
26 mm
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Chapter 1 Introduction
Caution!
16.6 mm
3
8 mm
30 mm
65 mm
1.5.7 Reagent vials and appropriate adapters
The adapters that are appropriate for individual reagent vials are shown below.
Use the correct adapter. If the correct adapter is not used, the reagent cannot be aspirated
correctly and may cause a probe to crash resulting in an aspiration error.
Reagent vials and appropriate adapters that can be used on reagent table
Reagent vials Appropriate adapters
Siemens reagent vial 5 mL (GW5) Holder_ASSY NO.19 (Part No. AC833285)
40 mm
22 mm
Sample cup 4 mL (Cup 4 mL) Holder_ASSY NO.21 (Part No. CX073106)
Siemens reagent vial 15 mL
(GW15)
50 mm
30 mm
Adapters are not required except for Holder No. 5 on the
reagent rack (6 holes). Set the vial directly on the reagent
rack.
Siemens reagent vial 25 mL
(GW25)
Container_ASSY No. 36 (Part No. AP779078)
Can be used only for Holder No. 5 on the
reagent rack (6 holes).
Vials such as Siemens reagent vial 5 mL
(GW5) can be set by layering with
Holder_ASSY NO.19.
* CA Clean vials can be set only in Holder No. 5 on the reagent rack (6 holes).
Adapters are not required. Place them directly into the reagent rack.
CS-2500 Instructions for Use
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Revised March 2020
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Chapter 1 Introduction
30 mm
65 mm
Reagent vials and appropriate adapters that can be used on buffer table
Siemens reagent vial 5 mL (GW5) S/B adapter (GW5)
Reagent vial Appropriate adapters
S/B adapter (GW5)
(Part No. CW084217)
(right grip type)
(Part No. CM426721)
40 mm
22 mm
Siemens reagent vial
15 mL (GW15)
50 mm
30 mm
Siemens reagent vial
25 mL (GW25)
S/B Adapter (GW15)
(Part No.442-3098-7)
Sample cup 4 mL (Cup 4 mL) S/B Adapter (SC)
(Part No.442-3096-0)
16.6 mm
38 mm
S/B Adapter (GW15)
(Right grip type)
(Part No.CN620645)
S/B Adapter (SC)
(Right grip type)
(Part No.AQ749603)
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Chapter 1 Introduction
1.6 Technical information
This section explains technical information, such as the package contents, and installation method of the instrument.
1.6.1 Package contents
Please verify if the following items are in the package. Contact your local representative if any of the following
items are missing or damaged.
1.6.1.1 Main Unit/IPU/Pneumatic Unit
Name Quantity
Main Unit 1
IPU 1
Pneumatic Unit 1
1.6.1.2 Accessories
Accessories
Part No. Description Quantity
BT392405 CDR_ASSY NO.211 (CDR2CS4D) 1
AW700886 CDR3CS2X (CS-series Data Base CD-ROM) 1
92380928 POWER CORD NO.15 (C-2/N.AMER) 1
BX770315 Sampler rack package assembly (WHITE) (6 racks) (with Holder No. 59) 2
BU985293 Barcode label for reagent holder (CA CLEAN II) on CS2 (5 labels) 1
CU813644 Barcode label for Owren’s Veronal Buffer on CS2 (5 labels) 1
CW084217 S/B Adapter (GW5) 2
442-3098-7 S/B Adapter (GW15) (for GW15/GW25) 2
442-3096-0 S/B Adapter (SC) 2
AC833285 Holder_ASSY NO. 19 (GW5) 5
CX073106 Holder_ASSY NO. 21 (Cup) 6
CD466647 Reagent cap S (10) (Kit NO.109)
AH759521 Reagent cap L (10) (Kit NO.110)
CC907148 Cap NO.528 (10) (Kit NO.105) 1
BB564291 Cap NO.527 (10) (Kit NO.106) 1
AF252785 Trash Box Liner CS2 (5) (Kit NO.141)
AX801638 Reagent rack C-1 (Container_Assy_No. 34) 1
BV995710 Reagent rack C-2 (Container_Assy_No. 35) 1
BA515007 SLD mini cup (100pcs) SLD-400A MAIN PREPARATION
36617891
Tube holder No. 58 (WHITE) (14 mm diameter collection tube adapter, for
sample rack)
*
*
*
*
1
1
1
1
20
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Chapter 1 Introduction
Part No. Description Quantity
04349011 Filter Assy for Rinse Bottle 1
AP779078 Container_ASSY No. 36 4
CT488841 Label for rinse water tank (LABEL NO. 1060) 1
BB621572 Label for waste tank (LABEL NO.1062) 1
46223870 Screwdriver Phillips A6002 1
* Not for sale (➤ P.7-56 “Chapter 7: 7.11.1 Consumables”).
Main Unit accessories
Part No. Description Quantity
953-1082-1 Float switch No. 17 (for rinse water tank) 1
424-2400-4 20 L container (for rinse water tank) 1
CS252527 Cuvette trash tray 1
BB274286 CS2 Reagent table A cover (Cover_Assy No. 57) 1
BX820077 CS2 Reagent table B cover (Cover_Assy No. 58) 1
CA646494 CS2 Reagent table C cover (Cover_Assy No. 59) 1
265-9436-5 LAN cable NSEDT-PC-S-MP4P-2SB568B/AB 1
367-9228-2 Teflon mixer (micro rotor I 12.7 × φ3.0) (for reagent mixing) 3
442-5338-7 Tubes 6 × 4: 20 m 1
BK603598 Tubes 6.5 × 3 (silicon): 5 m 1
443-1369-5 Filter NO. 16A 1
CD260744 Holder_Assy NO. 28 1
424-1160-8 Sample cup conical 4 mL 20
BR795472 Barcode label No. 1 Barcode label (1-60) 2
369-7856-7 Display mark No. 553 1
266-7768-1 Fuse 50T100H 2
BB033811 CS Reagent rack A-1 (Container_Assy_No. 11) 1
AC527658 CS Reagent rack A-2 (Container_Assy_No. 12) 1
BU496600 CS Reagent rack A-3 (Container_Assy_No. 13) 1
AS961141 CS Reagent rack A-4 (Container_Assy_No. 14) 1
AY539778 CS Reagent rack A-5 (Container_Assy_No. 15) 1
BR673198 CS Reagent rack D-1 (Container_Assy_No. 21) 1
BQ339135 CS Reagent rack D-2 (Container_Assy_No. 22) 1
BH045576 CS Reagent rack D-3 (Container_Assy_No. 23) 1
BF780266 CS Reagent rack D-4 (Container_Assy_No. 24) 1
AM260869 CS Reagent rack D-5 (Container_Assy_No. 25) 1
073-1621-5 Tray No. 48 assembly 1
462-3010-1 Cuvette removal rod (hopper) 1
442-5430-3 Teflon 4.2×3.2 (L=330) (Cuvette removal rod (trash)) 1
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Chapter 1 Introduction
Caution!
Part No. Description Quantity
CR323182 Halogen lamp JB12V24WF6/SSM 1
CM095265 Filter NO. 513 1
AU666611 Filter NO. 514 2
CQ314797 Chute NO. 140 1
CF468084 Jig for wiping off (Jig No. 1104) 1
1.6.2 Installing the instrument
Make sure the Main Unit is free from external damage and check the quantity of the accessories before installing
the instrument.
Contact your local representative to install the complete system or if the instrument must be
moved after it is installed.
Please note that instrument problems that occur as a result of moving the instrument yourself
will be outside the scope of the warranty, even if they occur within the warranty period.
1.6.2.1 Installation space
To ensure optimal instrument performance, install it at an appropriate location.
• Select a place that is close to the power supply and a suitable drain.
• Secure enough space so that in an emergency you can cut off the power by unplugging the power cable.
• Secure at least a 5 cm clearance between the instrument’s rear panel and the wall.
(The minimum clearance between the rear filter and the wall is 2 cm.)
• Giving consideration to maintenance, servicing and heat radiation, separate the instrument by at least a 30 cm
clearance between the 2 sides and the wall.
• Additional desktop space is required when installing a printer.
The instrument dimensions are shown in the table below. The length of the power cord is 1.8 meters.
Width (mm) Depth (mm) Height (mm) Weight (kg)
Main Unit Approx. 775 Approx. 895 Approx. 685 Approx. 110
Pneumatic Unit Approx. 280 Approx. 355 Approx. 400 Approx. 17
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Chapter 1 Introduction
Caution!
Sampler
Sampler cover
Underside of the
sampler cover
• Do not install on an unstable location.
• Warm air is vented from the left side of the instrument. If you place cuvettes etc. on the left
side of the instrument, warm air will be made to circulate inside the instrument, raising its
recognition temperature above room temperature, and potentially causing abnormal
temperature errors.
• Secure at least a 5 cm clearance between the instrument’s rear panel and the wall.
(The minimum clearance between the rear filter and the wall is 2 cm.)
If the clearance between the rear panel and the wall is less than 5 cm, the intake of air from
outside to the interior of the instrument through the rear panel will be inadequate, potentially
causing abnormal temperature errors. It also encourages infiltration of air through the reagent
table cover, so that if the reagents are left for long periods with their lids not closed,
condensation or evaporation in the reagents could have an influence on data.
• When installing or moving the instrument, do not hold the underside of the sampler cover.
The sampler cover may come off, resulting in injury.
1-30
• Make sure the Pneumatic Unit is positioned lower than the instrument.
CS-2500 Instructions for Use
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Page 35
Dimensions of component units
Main Unit
775 mm
685 mm
895 mm
Rinse tank
Pneumatic Unit
Approx. 180 mm
Approx. 420 mm
Approx. 360 mm
280 mm
400 mm
355 mm
Chapter 1 Introduction
CS-2500 Instructions for Use
Revised March 2020
1-31
Page 36
Chapter 1 Introduction
Warning!
Screw
Cuvette hopper cover
Reagent section lid Cuvette hopper lid
1.6.2.2 Removing shipping holding fixtures
Remove shipping holding fixtures and tape.
1 Remove the screws of the Pneumatic Unit.
As shown on the right, the Pneumatic Unit is fixed with 2 screws at the bottom when
the instrument is shipped from the factory.
Loosen the screws using a Phillips screwdriver.
2
Open the reagent section lid and cuvette hopper lid, loosen the screw and
open the cuvette hopper cover.
When reaching into the inside of the instrument with the reagent section lid open, always check
that the lid is fully open. If it is not, the reagent section lid could fall down, injuring the user’s head
or elsewhere.
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Chapter 1 Introduction
Warning!
Light shield lid
Cover a
Screw
3
Open the light shield lid, remove the 2 screws in the figure below, then remove
Cover a.
When reaching into the inside of the instrument with the light shield lid open, always check that
the light shield lid is fully open. If it is not, the light shield lid could fall down, injuring the user’s
head or elsewhere.
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Chapter 1 Introduction
Holding fixture A
Reagent arm
Holding fixture A
Holding fixture C
Holding fixture B
(These are
under the cover)
Holding fixture B
(These are under
the cover)
Clamp Tape
Dispensing table cover Cover b
4
Remove the holding fixtures around the reagent table.
(1) Remove the clamp, then remove the holding fixtures A (2 places).
(2) Peel off the 2 places of tape fastening the reagent arm, then lift up the reagent arm.
(3) Remove the holding fixture C.
(4) Peel off the tapes (from 2 places), then remove holding fixtures B (2 places).
5
Open the dispensing table cover upwards, then remove Cover b.
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6
Supply catcher section
Tape
Tape
Holding fixture D
Peel off the tape fastening the supply catcher section.
7
Peel off the tape fastening the right side of the dispensing table.
Chapter 1 Introduction
8
Remove holding fixture D from the front of the dispensing table.
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Chapter 1 Introduction
Holding fixture E-1
Sample arm
Holding fixture E-3
Tape
Holding fixture E-2
STAT/buffer table cover
Holding
fixture F
9
Peel off the tape fastening the sample arm, lift up the sample arm, then
remove the holding fixtures E (3 places).
10
Open the STAT/buffer table cover and remove the holding fixture F.
11
Reversing steps 2 through 10, install the removed covers to their original
positions.
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Chapter 1 Introduction
Chute NO.140
Guide
1.6.2.3 Attaching chute No.140
1 Place chute No.140 on the guides of the cuvette trash box, then push it all the
way in.
2
Lift the inner side of chute No.140, so that it is drawn to the magnet above.
It will click into place.
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Chapter 1 Introduction
Cuvette trash box
1.6.2.4 Setting the cuvette trash box in place
1 Set the cuvette trash box in place.
If you are using Trash Box Liner CS2, set it
into the cuvette trash box in advance.
(➤ P.2-72 “Chapter 2: 2.7.6 Setting the
Trash Box Liner CS2”)
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1.6.2.5 Setting the filter and holder in place
Filter No.16A
Filter No.514
Filter No.513
1 Set filter No.16A in place.
Put between the instrument’s bottom plate
guides.
Chapter 1 Introduction
2
Set filter No.513 and filter No.514.
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Chapter 1 Introduction
Tray No.48
Projection
Notch
Tray No.48
1.6.2.6 Setting tray No.48
1 Set tray No.48 in its position under the Main Unit.
Align the position of the projection on the
underside of the Main Unit and the notch
on tray No.48, to set the tray in place. Push
the tray firmly all the way in.
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Chapter 1 Introduction
Warning!
Caution!
Light shield lid
Reagent
section lid
Lock lever
Reagent table cover A
Reagent table cover BReagent table cover C
1.6.2.7 Setting the reagent rack
1 Open the light shield lid and reagent section lid.
When reaching into the inside of the instrument with the light shield lid/reagent section lid open,
always check that the lid is fully open. If it is not, the light shield lid/reagent section lid could fall
down, injuring the user’s head or elsewhere.
2
Open the reagent table cover.
When removing table cover C, be sure to remove reagent table covers A and B first. Failure to do
so may cause damage to reagent table covers A and B.
Remove reagent table covers A and B,
then remove reagent table cover C.
Slide the lock levers for reagent table
covers A and B in the arrowed
directions, to unlock them, then lift
them up.
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Chapter 1 Introduction
Note:
Reagent rack (6 holes)
Table guides of the reagent table A
Table guide (small)
Table guide (right side)
3
Place the reagent rack (6 holes) between the table guides of the reagent table
A (outside).
• Turn the reagent table by hand to move it forward to
set the rack. Five reagent racks can be set.
• Make sure there is no space between the table and
the reagent rack.
When setting the reagent rack at position
No. 5 on the reagent table A, align the rack
between the table guide on the right and
the small table guide as shown in the
diagram.
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Chapter 1 Introduction
Warning!
Caution!
Warning!
Reagent racks (2 holes)
Table guides of the reagent table B
4
Place the reagent rack (2 holes) between the table guides of reagent table B
(inside).
• The reagent rack (2 holes) is usually left outside the
instrument, and used when it is necessary to add a
reagent vial.
• Turn the reagent table by hand to move it forward to
set the rack. Five reagent racks can be set.
• Make sure there is no space between the table and
the reagent rack.
5
6
Close the reagent table cover and reagent section lid.
When closing the reagent section lid, take care not to pinch your fingers.
When setting table covers A and B, be sure to set reagent table cover C first, then slide the lock
levers to lock them. Reagent table covers A and B could be damaged if you attempt to set
reagent table cover C after setting reagent table covers A and B.
Close the light shield lid.
When closing the light shield lid, take care not to pinch your fingers.
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Chapter 1 Introduction
Caution!
Rack label mark
Rack barcode label
Rinse tank
Left side of the Main Unit
Connection
(2) Float sensor connector for rinse tank (Rns)(1) Rinse aspiration nipple (Rns)
(1) Urethane tube (6×4)
(2) Float switch cable
1.6.2.8 Affixing barcode labels to the sample rack
Affix the rack label marks and rack barcode labels on the sampler racks that come with this instrument.
• There are 12 rack label marks and barcode labels, each of
which is numbered 1 to 12.
• Affix a rack label mark and a barcode label that have the same
number to a sample rack, as shown in the diagram on the
right.
• Align the top of the rack barcode label with the top of the rack.
1.6.2.9 Connecting the rinse tank and waste tank
Connect the rinse tank and the waste tank.
The waste tank is optional. If no waste tank is attached, discard waste fluids according to the operation practices
of the facility.
Be sure to connect the rinse tank and waste tank before turning the Main Unit power on.
1 Connect the Main Unit and the rinse tank.
(1) Connect the rinse tank nipple and the rinse aspiration nipple (Rns) on the left side of the Main Unit with
(2) Connect the float switch cable of the rinse tank to the rinse water float sensor connector (Rns).
the urethane tube provided (6×4).
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Chapter 1 Introduction
Waste tank
(or to a drain)
Left side of the Main Unit
Connection
(2) Float sensor connector for waste tank (W)(1) Waste outlet nipple (W)
(1) Urethane tube (6×4) or
silicone tube (6.5×3)
(2) Float switch cable
(1) Overflow waste line
nipple (sample) (O)
(1) Overflow waste line
nipple (reagent) (O)
2
Connect the Main Unit and the waste tank.
(1) Connect the urethane tube provided (6×4) to the waste outlet nipple (W), and the silicone tube provided
(6.5×3) to the overflow waste line nipple (reagent) (O), and to the overflow waste line nipple (sample) (O).
Connect these tubes to a drain, or to an optional waste tank.
(2) Connect the float switch cable of the waste tank to the waste float sensor connector (W).
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Chapter 1 Introduction
Right side of the Main Unit
IPU
IPU connector
LAN cable provided
1.6.2.10 Connecting each unit
Connect the IPU and the Pneumatic Unit to the Main Unit, then connect the power cord.
Also, connect the host computer and printer to the IPU.
1 Make sure the Main Unit power switch is OFF.
The power is OFF when “O” on the power switch is pressed.
2
Connect the Main Unit and the IPU.
Connect the IPU connector on the right side of the Main Unit and the connector on the back of the IPU with the
LAN cable provided.
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Chapter 1 Introduction
Rear of the
Pneumatic Unit
Left side of the Main Unit
(3) Pneumatic Unit
control input
connector
(1) Pressure outlet nipple (P)
(2) Vacuum outlet nipple (V)
(1) Pressure inlet nipple (P)
Connection
(2) Vacuum inlet nipple (V)
(3) Pneumatic Unit
control connector
3
Connect the Main Unit and the Pneumatic Unit.
(1) Connect the pressure outlet nipple (P) on the back of the Pneumatic Unit and the pressure inlet nipple
(P) on the left side of the Main Unit with the urethane tube provided (6×4).
(2) Connect the vacuum outlet nipple (V) on the back of the Pneumatic Unit and the vacuum inlet nipple (V)
on the left side of the Main Unit with the urethane tube provided (6×4).
(3) Connect the Pneumatic Unit control input connector on the back of the Pneumatic Unit and the
Pneumatic Unit control connector on the left side of the Main Unit with the Pneumatic Unit control cable.
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Chapter 1 Introduction
Warning!
Left side of the Main Unit
117 V outlet
Power connector
Power cord provided
Rear of the
Pneumatic Unit
Power cord provided
Power connector
117 V outlet
4
Connect the power cord of the Main Unit and the Pneumatic Unit.
• Use the power cord that comes with the instrument. Also, do not use it with any other
instrument.
• Always ground this instrument.
Inadequate grounding creates the danger of electric shock.
• Make sure the Main Unit power switch is OFF before connecting the power cord.
Otherwise, you could suffer an electric shock.
Insert the Main Unit power cord provided into the power connector on the left side of the Main Unit and the
outlet.
1-48
Insert the Pneumatic Unit power cord provided into the power connector on the back of the Pneumatic Unit and
the outlet.
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Chapter 1 Introduction
Caution!
5
Connect the IPU and the host computer/printer.
Switch OFF the power supply before connecting distribution cables.
Otherwise, the unit may be damaged.
1.6.2.11 Setting Up the System
Set the system to make the connected units operable.
1 Tick [Monitor waste float switch] on the monitoring screen of the [System
Settings] dialog box.
Tick this checkbox when monitoring the waste fluid volume using the float switch of the waste tank.
(➤ P.4-1 “Chapter 4: 4.1.1 [System Settings] dialog box and the setting parameter tree”)
(➤ P.4-27 “Chapter 4: 4.1.7.16 [Monitoring] screen”)
2
Set the method for connecting to the host computer.
(➤ P.4-31 “Chapter 4: 4.1.7.18 [Host Computer] screen”)
3
Set the printer.
(➤ P.4-34 “Chapter 4: 4.1.7.19 [Printer] screen”)
4
Make other settings required for the system.
Make necessary settings according to the institution’s operational needs.
(➤ P.4-1 “Chapter 4: 4.1 Setting up the system”)
5
Restart the IPU and the Main Unit.
The settings are reflected on the instrument.
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Chapter 1 Introduction
1.6.2.12 Filling with rinse water
Correct analysis is not possible unless the hydraulic line of the instrument has sufficient rinse water.
Prime the rinse inside the hydraulic line, as follows.
1 Fill the rinse tank with rinse water.
(➤ P.2-125 “Chapter 2: 2.8.9.5 Replenishing rinse water”)
2
Turn on the IPU first, then the Main Unit.
(➤ P.2-13 “Chapter 2: 2.4.4 Turning ON the power”)
3
Priming the hydraulic line.
(➤ P.7-36 “Chapter 7: 7.8.2 Priming the hydraulic line”)
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1.6.3 ID barcode specifications
Caution!
1.6.3.1 Acceptable barcode
The types of barcode acceptable to the instrument and the check digit(s) are listed below.
Use a check digit as much as possible.
If the check digit cannot be used, incorrect reading of the barcode label may result.
● Sample No.
Type of barcode Check digit No. of digits
ITF Not Used 1-15 digits (Sample ID No.)
Modulus 10 1-15 digits (Sample ID No.)
+1 digit (Check digit) =16 digits Max.
*
NW-7 (CODABAR)
CODE-39 Not Used 1-15 digits (Sample ID No.)
JAN-13 Modulus 10 12 digits (Sample ID No.)
JAN-8 Modulus 10 7 digits (Sample ID No.)
CODE-128 Modulus 103 1-15 digits (Sample ID No.)
ISBT128 Modulus 103 “=” or “&” + 13 digits (Sample ID No.)
Not Used 1-15 digits (Sample ID No.)
Modulus 11 1-15 digits (Sample ID No.)
W.Modulus 11
Modulus 16
Modulus 43 1-15 digits (Sample ID No.)
+1 digit (Check digit) =16 digits Max.
+1 digit (Check digit) =16 digits Max.
+1 digit (Check digit) =13 digits
+1 digit (Check digit) = 8 digits
+1 digit (Check digit) = 16 digits Max.
+1 digit (Check digit) =15 digits
Chapter 1 Introduction
CS-2500 Instructions for Use
* As the Start and Stop codes, use one of the characters “A”, “B”, “C”, “a”, “b” and “c”.
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Chapter 1 Introduction
● QC File No.
QC File No. can be read if printed with CODE-39 or CODE-128.
Type of barcode Check digit No. of digits (File No.) No. of digits for check digit
CODE-39 Either of “Use”
CODE-128 “Use” 4 digits “QC01”, “QC02”, ... “QC20” 1 digit
● Rack No.
Type of barcode Check digit No. of digits
NW-7 (CODABAR)
CODE-39 Modulus 43 6 digits (Rack No.)
* As the Start and Stop codes, use one of the characters “D” and “d”.
4 digits “QC01”, “QC02”, ... “QC20” Not Used or 1 digit
or “Not Use”
*
Modulus 16 6 digits (Rack No.)
+1 digit (Check digit) = 7 digits
+1 digit (Check digit) = 7 digits
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Chapter 1 Introduction
1.6.3.2 Check digit
To improve the reliability of an ID No. read, check digit(s) can be added.
This section explains how to calculate the check digit for modulus 11 and weighted modulus 11.
● Modulus 11
The following example uses the sample ID No. 258416.
1 Assign a weight to each digit.
258416
ЧЧЧЧЧЧ
Weight765432
14 30 40 16 3 12
2
Add the multiplied results as given below.
S = 14 + 30 + 40 + 16 + 3 + 12 = 115
3
When S is divided by 11, calculate the remainder and obtain the complement
of the remainder.
This complement will be the check digit.
115 ÷ 11 = 10 with remainder 5
11 - 5 = 6, thus the check digit is 6.
However, all English symbols except the numerals of 0 - 9 are regarded as 0 in making the calculation. Also,
when S is divisible by 11 with remainder 0 and when calculation of the check digit results in 10, zero is entered
as the check digit.
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Chapter 1 Introduction
Note:
● Weighted Modulus 11
Weighted modulus 11 has 2 sets of weight. When the check digit is computed to 10 as a result of applying the
first weight set, the second weight set is applied. The result should always be between 0 and 9. The calculation
method is exactly the same as modulus 11 except for the difference in weighting.
The following example uses the sample ID No. 258416.
1 Assign a weight to each digit.
Weight: W12 W11 W10 W9 W8 W7 W6 W5 W4 W3 W2 W1
First Set:6 3 5 9107845362
Second Set:5 8 6 2104376859
258416
ЧЧЧЧЧЧ
Weight845362
16 20 40 12 6 12
2
Add the multiplied results as given below.
S = 16 + 20 + 40 + 12 + 6 + 12 = 106
3
When S is divided by 11, calculate the remainder and obtain the complement
of the remainder.
This complement will be the check digit.
106 ÷ 11 = 9 with remainder 7
11 – 7 = 4, thus the check digit is 4.
However, all English symbols except the numerals of 0 - 9 are regarded as 0 in making the calculation. Also,
when S is divisible by 11 with remainder 0 and when calculation of the check digit results in 0, zero is set as the
check digit.
Weight for the 13th to 15th digits is assumed to be 0.
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Chapter 2 Principles of Operation
Caution!
Note:
Chapter 2 Principles of Operation
2.1 System overview
This instrument is a fully automated blood coagulation analyzer for in vitro diagnostic use that can quickly analyze a
large volume of samples with a high degree of accuracy.
This instrument can analyze samples using clotting, chromogenic and immunoassay methods.
Analysis results are displayed on the IPU (Information Processing Unit) screen. They can be printed on external
printers or transmitted to a host computer.
* This manual refers to Information Processing Unit as IPU.
• Results should always be evaluated in conjunction with clinical and other laboratory findings.
• Independent of the concentration of analysis samples, nonspecific reactions may be obtained
in some cases. Therefore, the dilution of samples may lead to discordant results in certain
cases.
• It may not be possible to obtain correct analysis results if the test protocol is changed. Proceed
at your own risk if you attempt to change the test protocol. Furthermore, the warranty for this
product only covers use of the factory default settings.
• Do not use results analyzed with research reagents for patient diagnosis.
• You are not permitted to copy a portion of this manual or to copy the entire manual without
express permission.
• Patient names listed in this manual bear no resemblance to the names of actual people.
• Images in these instructions for use related to the product are for illustration purposes only
and may not exactly match with what is found on the product itself.
• While we have taken all possible precautions to ensure quality in the content of this manual,
please contact the Service Department of your local Sysmex representative if you find any
errors or omissions.
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Chapter 2 Principles of Operation
2.2 Assay parameters (analysis parameters and calculated parameters)
This instrument analyzes and calculates the following parameters.
Analysis
method
Clotting Prothrombin Time (PT) INR
Activated Partial Thromboplastin Time (APTT)
Fibrinogen clotting time (Fbg) Fibrinogen concentration
Thrombin Time (TT)
Batroxobin Time (BTX)
Extrinsic Factor Deficiency Assay (II, V, VII, X)Factor II Activity Percent
Intrinsic Factor Activity Assay (VIII, IX, XI, XII)Factor VIII Activity Percent
Lupus Anticoagulant Ratio
Factor V Leiden Ratio
Protein C (PC) Protein C Activity Percent
Chromogenic Antithrombin (AT) Antithrombin Activity Percent
INNOVANCE Heparin Heparin concentration
Protein C (PC) Protein C Activity Percent
α2-Antiplasmin α2-Antiplasmin Activity Percent
Plasminogen (Plg) Plasminogen Activity Percent
Factor VIII Chromogenic (F VIII CH) Factor VIII Activity Percent
Immunoassay D-dimer D-dimer concentration
Free Protein S Free Protein S concentration
Analysis parameters Calculated parameters
Assay parameter
Factor V Activity Percent
Factor VII Activity Percent
Factor X Activity Percent
Factor IX Activity Percent
Factor XI Activity Percent
Factor XII Activity Percent
2.3 Analysis overview
Different types and modes of analysis are available for this instrument, and various analysis methods can be set up.
2.3.1 Types of analysis
There are 4 types of analysis, as shown below:
Normal analysis
Normal analysis is a basic analysis in which samples in the sample rack are set in the sampler.
(➤ P.2-81 “Chapter 2: 2.8.3 Sending an order inquiry to the host computer to perform analysis”)
(➤ P.2-85 “Chapter 2: 2.8.4 Manually registering the orders to perform analysis”)
STAT sample analysis
STAT sample analysis analyzes the samples requiring urgent analysis by setting them in the STAT/buffer table.
STAT sample analysis is prioritized over normal sample analysis, QC analysis and calibration curve analysis.
(➤ P.2-107 “Chapter 2: 2.8.5 Analyzing STAT samples”)
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Chapter 2 Principles of Operation
QC analysis
QC analysis is performed for the purpose of quality control. There are 2 different QC analysis methods: one
uses a control set in the sample rack and the other uses a control set in the reagent table.
(➤ P.2-168 “Chapter 2: 2.10 Performing QC analysis”)
Calibration curve analysis
Calibration curve analysis is performed in order to create a calibration curve. It analyzes a calibrator which is set
in the reagent table.
(➤ P.5-1 “Chapter 5 Creating Calibration Curves”)
2.3.2 Analysis modes
Normal mode and micro-sample mode are the two available analysis modes. The choice of the mode depends
on the intended application and volume of patient specimen available.
Normal mode - Capped/Closed and Uncapped/Open tube sampling
Samples for all the analysis including re-analysis are taken into the instrument in sample racks, from the
sampler, at the same time and analyzed. In normal mode, a capped and/or uncapped sample tube analysis can
be performed. Specimens in capped and uncapped sample tubes can be loaded into the same sample rack at
the same time and analyzed. Automatic re-analysis can also be performed.
Micro-sample mode - Uncapped/Open tube sampling only
The sample volume from samples either set in the sampler or STAT holder is taken into the instrument for each
analysis and analyzed. Micro-sample mode cannot be used with capped sample tubes. Micro-sample mode
requires the use of uncapped/open sample tubes. This analysis mode uses less sample volume than normal
mode. However, automatic re-analysis cannot be performed.
(➤ P.2-98 “Chapter 2: 2.8.4.5 Setting the analysis mode and analysis method”)
2.3.3 Analysis method
This instrument can perform the following analysis methods: See below for the analysis mode setting method.
(➤ P.2-98 “Chapter 2: 2.8.4.5 Setting the analysis mode and analysis method”)
Dilution analysis
This method performs analysis by specifying the dilution ratio for each analysis parameter during order
registration. The dilution ratio can be specified using the assay group settings dialog box.
Multi-Dilution Analysis (MDA)
One sample is analyzed for one analysis parameter using multiple dilution ratios.
In order to reduce dilution effects in the reaction, values are calculated based on the analysis results using
multiple dilution ratios.
Automatic re-analysis
A judgment is made whether to perform an automatic re-analysis when the calculation of all the analysis results
for one assay group is completed. If there are multiple analysis parameters for a sample, judgment is made for
each parameter.
Judgment for automatic re-analysis is conducted in the order of redilution analysis, re-analysis and reflex test.
Judgment is completed when any of the judgment criteria are met. However, automatic re-analysis cannot be
executed in micro-sample mode.
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Chapter 2 Principles of Operation
Redilution analysis
When the analysis results do not meet the set conditions, re-analysis is performed automatically using a
specified dilution ratio. Conditions and dilution ratio for executing the redilution analysis can be set in the assay
group settings dialog box.
Re-analysis
When the analysis results do not meet the set conditions, re-analysis is performed automatically. Conditions for
executing the re-analysis can be set in the assay group settings dialog box.
Reflex test
When the analysis results meet the set conditions, another parameter satisfying these conditions is analyzed
automatically. Conditions for executing the analysis can be set in the assay group settings dialog box.
2.3.4 Compatibility table for analysis modes/analysis types/analysis
methods
Analysis method
Types of
analysis
Normal
analysis
STAT sample
analysis
QC analysis Sampler Normal/Micro-
Calibration
curve analysis
Sample set
position
Sampler Normal/Micro-
STAT holder Normal/Micro-
Reagent
table
Reagent
table
Analysis
modes
sample
sample
sample
Micro-sample — —— — —
Micro-sample — —— — —
Piercing
—
—— — —
*1
Dilution
analysis
MDA
Automatic re-analysis
*2
Redilution
analysis
Re-
analysis
Reflex
test
2-4
: Possible
: Only possible in normal mode
—: Impossible
*1: In normal mode, a capped sample tube analysis can be performed.
*2: Automatic re-analysis cannot be performed in MDA.
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Chapter 2 Principles of Operation
Inspect before turning power ON.
➤ P.2-12 “2.4.3 Inspecting before turning power ON”
Turn ON the power.
➤ P.2-13 “2.4.4 Turning ON the power”
Prepare for analysis.
Set the reagent/detergent/buffer. Replenish cuvettes.
Set SB Cuvettes
(cuvettes containing stir bars).
Prepare samples.
Create calibration curves.
Perform QC analysis.
Analyze samples.
Check analysis results.
2.4 Basic operations
This section explains what you need to know to operate the instrument and its basic operations.
2.4.1 Overview
The major contents of this section are:
Design and function
This section explains the design and function of all parts of the instrument.
Basic screen configuration
This section explains the configuration and function of the IPU screen.
Basic operations
This section explains the basic operations of the instrument including power ON/OFF and logging off.
The process to turn the power ON
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Chapter 2 Principles of Operation
2.4.2 Basic screen configuration
This section explains what you need to know about screen configuration before operating the IPU.
2.4.2.1 Common screen display
There are buttons that are common to several different screens of this instrument.
This section describes the functions of these buttons.
Button Function
Moves the list one page to the left or right.
Moves the selected items and cursor on the list one place to the left or right.
Moves the list one page up or down.
Moves the selected items and cursor on the list one place up or down.
Moves the selected items and cursor on the list to the top or bottom line.
This is the numerical keypad for entering numbers in the input field.
Appears when the number of items on the item list has exceeded the
maximum number of items that can be displayed at a time. When pressed, it
can display the next items.
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2.4.2.2 Display screen overview
Tool bar
View
Status bar
The IPU display screen is composed as follows.
Chapter 2 Principles of Operation
● Toolbar
The Toolbar contains shortcut buttons for the main functions. The buttons below will be displayed.
Button Function Button Function
Displays the [Menu] screen. Displays the [Reagent] screen.
(➤ P.2-28 “Chapter 2:
2.7.2 [Reagent] screen”)
Displays the [CalibrationCurve]
screen.
(➤ P.5-14 “Chapter 5: 5.4.1
[CalibrationCurve] screen”)
Displays the [Order] screen.
(➤ P.2-85 “Chapter 2:
2.8.4.1 [Order] screen”)
Displays the [Status Display] screen.
(➤ P.7-3 “Chapter 7: 7.3 [Status
Display] screen”)
Shuts down the instrument.
(➤ P.2-17 “Chapter 2:
2.4.6 Shutdown”)
Displays the [QC Chart] screen.
(➤ P.2-191 “Chapter 2:
2.10.3.1 [QC Chart] screen”)
Displays the [Joblist] screen.
(➤ P.2-129 “Chapter 2:
2.9.2.1 [Joblist] screen”)
Displays the [Maintenance] screen.
(➤ P.7-6 “Chapter 7: 7.4
[Maintenance] screen”)
Displays the [STAT Order] screen.
(➤ P.2-107 “Chapter 2:
2.8.5.1 [STAT Order] screen”)
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Note:
Button Function Button Function
Interrupts the analysis. Starts the analysis.
● View
If you are using a wide-screen display, the view content may be displayed at the center of the
screen, or it may be enlarged to fit the screen, depending on the selected screen display.
This is the area for operating the functions of the instrument. It changes depending on which function is
displayed on the screen.
The following icons are displayed on the menu screen.
Icon Function Icon Function
Displays the [STAT Order] screen.
(➤ P.2-107 “Chapter 2:
2.8.5.1 [STAT Order] screen”)
Displays the [Reagent] screen.
(➤ P.2-28 “Chapter 2:
2.7.2 [Reagent] screen”)
Displays the [CalibrationCurve]
screen.
(➤ P.5-14 “Chapter 5: 5.4.1
[CalibrationCurve] screen”)
Displays the [Order] screen.
(➤ P.2-85 “Chapter 2:
2.8.4.1 [Order] screen”)
Displays the [Status Display] screen.
(➤ P.7-3 “Chapter 7: 7.3 [Status
Display] screen”)
Shuts down the instrument.
(➤ P.2-17 “Chapter 2:
2.4.6 Shutdown”)
Displays the setup screen.
(➤ P.4-1 “Chapter 4: 4.1 Setting up
the system”)
Displays the version information. Displays the Test Menu screen.
Displays the [QC Chart] screen.
(➤ P.2-191 “Chapter 2:
2.10.3.1 [QC Chart] screen”)
Displays the [Joblist] screen.
(➤ P.2-129 “Chapter 2:
2.9.2.1 [Joblist] screen”)
Displays the [Maintenance] screen.
(➤ P.7-6 “Chapter 7: 7.4
[Maintenance] screen”)
Logs off the IPU.
(➤ P.2-16 “Chapter 2: 2.4.5 Logging
off”)
Displays the [Operation Log] screen.
(➤ P.7-59 “Chapter 7: 7.12 Checking
the operation log”)
(➤ P.8-50 “Chapter 8: 8.6 Testing
barcode reading”)
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Status of Main Unit
Status of host computer
Message
Indicator
Remaining time display area Help button
Current time display area
Main Unit nickname
Instrument status message
(Color)
*1: Long flashing red turns to solid red when the alarm is stopped.
Message Color Status
[Ready] Green Ready to start analysis.
Orange Analysis can be started but
consumables are used up.
[Int. Ready] Green Analysis has been interrupted by
interruption operation.
Orange Analysis has been interrupted and
consumables are used up.
Red Analysis has been automatically stopped
by the instrument.
[Warming Up] Flashing
green
Warming up.
[Processing] Flashing
green
Analysis is being performed or the
instrument is being operated.
Flashing
orange
Analysis is being performed or the
instrument is being operated, and
consumables are used up.
[Not Ready] Red • Analysis has been automatically
stopped by the instrument.
• The analysis cannot be started due to
an error.
Long flashing
red
*1
[OFF] Gray The Main Unit is not connected.
Flashing
green
The Main Unit is not connected,
but cooling function is running.
● Status bar
Displays the status of the IPU and instrument. The status bar is composed as follows.
Main Unit Status Displays the status of the Main Unit.
Main Unit nickname Displays the name set by selecting [Instrument Settings] in the [System
Settings] dialog box → [Instrument Information]. The factory default setting is
displayed as CS-2500.
Instrument status
message/(color)
Displays the following messages and colors depending on the status of the
instrument.
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Color Status
White There are no uncorrected errors.
Yellow [Not Corrected] is being displayed in the [Status] colum.
(There is an uncorrected error.)
Color Status
Gray All temperatures are in normal range.
Red Some temperatures are outside normal range.
Light gray The Main Unit is not connected.
Color Status
Gray Reagent quantities are adequate, or the remaining
quantities of all set reagents are unknown.
Yellow One or more reagents are low.
Red A reagent has run out.
Light gray The Main Unit is not connected.
Color Status
Gray The remaining number of cuvettes and the capacity of
the cuvette trash box are sufficient.
Yellow The remaining number of cuvettes and the capacity of
the cuvette trash box are low.
Red • There are no cuvettes.
• There is no space in the cuvette trash box.
Light gray The Main Unit is not connected.
Message Displays error messages.
Remaining time display area Displays the time until the measurement of the last sample is completed
Help button Displays the status of an error as shown in the table. Pressing the Help
Current time display area Displays the current time.
Indicator
(Temperature) Displays the temperature of the constant-temperature section (reagent
When this field is pressed, the [Error Help] dialog box appears. See the
following for details of the [Error Help] dialog box.
(➤ P.8-3 “Chapter 8: 8.3 When an error is displayed”)
when the instrument status is [Not Ready].
button displays the [Error Help] dialog box.
(➤ P.8-3 “Chapter 8: 8.3 When an error is displayed”)
cooling unit, reagent probe, detector and sample incubator) of the Main Unit.
(Reagent) The remaining volume of reagent is displayed.
(Cuvette) The remaining number of cuvettes and status of the cuvette trash box are
displayed.
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Color Status
Gray There is a sufficient amount of rinse water.
Yellow Rinse water is used up.
Red There is no rinse water.
Light gray The Main Unit is not connected.
Setting
button
Communication status
Color Status
Green Connecting
Red A communication error occurred.
(Blank) The setting on the instrument indicates that the host
computer will not be used.
(Rinse water) The remaining volume of rinse water is displayed.
Status of host computer The status of communications with the host computer is displayed.
Setting button The [System Settings] dialog box ([Host Computer]
screen) is displayed. (➤ P.4-31 “Chapter 4:
4.1.7.18 [Host Computer] screen”)
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2.4.3 Inspecting before turning power ON
Before turning ON the instrument, check the following items:
Rinse tank inspection
Make sure there is enough rinse water.
(➤ P.7-3 “Chapter 7: 7.3 [Status Display] screen”)
If it is low, fill the rinse tank with purified water.
(➤ P.2-125 “Chapter 2: 2.8.9.5 Replenishing rinse water”)
Waste tank inspection
If a waste tank is connected, check the fluid level in the tank.
(➤ P.7-3 “Chapter 7: 7.3 [Status Display] screen”)
If the volume is too high, discard the waste fluid.
(➤ P.7-13 “Chapter 7: 7.5.3 Discarding waste fluids”)
Instrument inspection
Check the tubing and cord connections. Make sure that no tubes are disconnected or kinked, and that the power
cords of the instrument and the Pneumatic Unit are securely plugged into the AC outlet.
Checking the printer paper
When using a printer, make sure that the supply of printing paper is enough for the number of samples to be
processed during the day.
Cuvette trash box inspection
Throw away any used cuvettes that are left in the cuvette trash box.
(➤ P.7-10 “Chapter 7: 7.5.2 Discarding used cuvettes”)
Replenishing cuvettes
Add more cuvettes if there are not enough in the cuvette hopper.
(➤ P.2-123 “Chapter 2: 2.8.9.3 Replenishing cuvettes”)
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Information
Note:
2.4.4 Turning ON the power
Follow the procedure below to turn ON the instrument.
• Check if a rinse tank and/or waste tank is connected before turning ON the Main Unit power.
• Turn the IPU power ON before turning on the power of the Main Unit. If the Main Unit is turned
on first, connection may not be established between the Main Unit and IPU.
• The power supply of the Pneumatic Unit is controlled from the Main Unit.
• After the power is turned ON, it will take a maximum of 30 minutes for the incubator, detector,
reagent probe and reagent table of the Main Unit to reach the prescribed temperature to
perform analysis.
1 Turn the printer power ON.
2
Turn the IPU power ON.
Startup processing of the IPU, such as opening of the database, starts.
The screen on the right appears during
processing.
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Logon
button
[Logon] dialog box
The [Logon] dialog box appears when the
startup is complete.
3
Press the Logon button in the [Logon] dialog box.
The dialog box on the right appears.
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4
Note:
Menu screen
Status bar
Power switch
Enter [Logon Name] and [Password], then press [OK].
The menu screen will appear.
Chapter 2 Principles of Operation
See below for the method of user administration.
(
➤P.4-36 “Chapter 4: 4.2 User administration”)
5
Turn the Main Unit power switch ON.
When the status display of the Main Unit on
the IPU status bar changes from [Warming
Up] to [Ready], analysis can be started.
After the Main Unit power switch is turned
ON, it will take a maximum of 30 minutes to
start analysis.
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Logon button
[Logon] dialog box
2.4.5 Logging off
When changing the user, first log off from the IPU, and then log on again. When PC is left unattended for long
periods of time it is recommended to log off.
1 Press the [Logoff] icon on the IPU menu screen.
The dialog box on the right appears.
2
Press [OK].
The IPU logs off and the [Logon] dialog box
appears.
When changing the user, press the Logon button
of another user and log on again.
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Caution!
Caution!
2.4.6 Shutdown
Follow the procedure below to shut down the instrument.
To ensure the stable use of the instrument, shut down the instrument at least once every 24 hours.
The instrument cannot be shut down during analysis or during an analysis interruption.
The instrument can be shut down using one of the following 2 methods; (1) Switch the instrument to sleep mode
which will maintain the refrigeration of the reagent/s inside the instrument, or (2) Turn OFF the Main Unit’s power
which will not maintain refrigeration of the reagent.
When [Automatically Shut Down IPU] is selected on the [Timer] screen in the [System Settings] dialog box, the
IPU is automatically shut down 30 seconds after the shutdown of the instrument.
(➤ P.4-24 “Chapter 4: 4.1.7.13 [Timer] screen”)
• Handle and store reagents according to the instructions attached to the reagent and
application/reference guide.
• Reagents can also be stored cooled inside the instrument overnight. For the sake of reagent
storage stability the reagents should be stored in one of the following ways, if no analysis will
be performed for a long period.
• Store cooled reagents with lids on in the instrument.
• Remove the reagents from the instrument and store them with lids on in the refrigerator.
Leaving reagents with open lids for long periods may result in incorrect analysis results.
If the reagents are stored in the instrument with the vial lids closed, make sure to remove
those lids before measuring the remaining reagent volume or performing an analysis. Failure
to do so may result in probe crash error.
2.4.6.1 Sleep mode
The sleep mode allows the reagents to be stored cooled inside the instrument by shutting down without turning
OFF the Main Unit power.
• In sleep mode, the waste tank cannot be removed after shutdown.
This is because waste fluids are regularly discarded, concurrently with the condensation
removal that is carried out while the reagent is cooled.
Discard waste fluids before switching the instrument to sleep mode.
(
➤ P.7-13 “Chapter 7: 7.5.3 Discarding waste fluids”)
• The storage stability of reagents varies with the cooling temperature, whether or not the
reagent vials are covered with lids, the types of reagents and their fluid volumes. QC analysis
at appropriate intervals are necessary to maintain the reliability of analyzed data.
• Do not open the reagent table cover while the instrument is in sleep mode. If any of the
reagent table covers A, B and C is opened while the instrument is in sleep mode, an alarm will
sound every 3 seconds.
If the cover is left open with reagents set in the instrument, the reagents will not be stored
cooled and may deteriorate. Perform QC analysis to check for any deterioration in quality.
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Reagent table A
Reagent table B
1 Check if CA CLEAN I is set on the reagent table A or B.
(➤ P.2-38 “Chapter 2: 2.7.3.1 Setting the
reagent/detergent/buffer”)
* Probe rinse is performed on shutdown, so check
that at least 8mL of CA CLEAN I is set in place.
2
Press the [Shutdown] icon on the IPU menu screen.
Or press the [Shutdown] button on the toolbar.
The dialog box on the right appears.
2-18
3
Select [Reagent cooling is continued], then press [OK].
The shutdown process starts and the progress bar appears during processing.
* When [Automatically Shut Down IPU] is selected on the [Timer] screen, the following steps are not required.
(➤ P.4-24 “Chapter 4: 4.1.7.13 [Timer] screen”)
The confirmation dialog box appears when the shutdown is complete.
4
Press [OK].
The dialog box closes.
5
Press [×] on the upper right corner of the screen to exit the IPU.
6
Shut down Windows.
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Caution!
Mechanical Stop switch
● Recovery from sleep mode
Follow the procedure below to return to an analyzable state from the sleep mode.
1 Turn the IPU power ON.
Startup processing of the IPU starts. The [Logon] dialog box appears when the startup is complete.
2
Log on.
(➤ P.2-14 “Chapter 2: 2.4.4 Turning ON the power” steps 3-4)
The instrument is ready to analyze.
● In case of an error while the instrument is in sleep mode
When an error occurs while the instrument is in sleep mode, the alarm indicator LED on the Main Unit changes
from green flashing to red flashing, and an alarm sounds.
If this happens, follow the procedure below.
If an error occurs during sleep mode, it is possible that the quality of the reagent may have been
adversely affected while stored cooled. Perform QC analysis to check the quality of the reagent.
1 Press the Mechanical Stop switch on the Main Unit.
This stops the alarm.
2
Turn the IPU power ON.
Startup processing of the IPU starts. The [Logon] dialog box appears when the startup is complete.
3
Log on.
(➤ P.2-14 “Chapter 2: 2.4.4 Turning ON the power” steps 3-4)
CS-2500 Instructions for Use
4
Check the details of the error.
(➤ P.8-8 “Chapter 8: 8.5 Error message list”)
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Caution!
Reagent table A
Reagent table B
2.4.6.2 Turning OFF the Main Unit power
Follow the procedure below to shut down the instrument without storing reagents cooled in the instrument.
Turn OFF the Main Unit power after shutting down the IPU.
If the Main Unit power is turned OFF without shutting down the IPU, [S3I/O Communication
Error] may occur.
1 Check if CA CLEAN I is set on the reagent table A or B.
(➤ P.2-38 “Chapter 2: 2.7.3.1 Setting the
reagent/detergent/buffer”)
* Probe rinse is performed on shutdown, so check
that at least 8 mL of CA CLEAN I is set in place.
2
Press the [Shutdown] icon on the IPU menu screen.
Or press the [Shutdown] button on the toolbar.
The dialog box on the right appears.
3
Select [Turn the Main Unit OFF], then press [OK].
The shutdown process starts and the progress bar appears during processing.
* When [Automatically Shut Down IPU] is selected on the [Timer] screen, skip step 4 to 6.
(➤ P.4-24 “Chapter 4: 4.1.7.13 [Timer] screen”)
The confirmation dialog box appears when the shutdown is complete.
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Power switch
4
Press [OK].
The dialog box closes.
5
Press [×] on the upper right corner of the screen to exit the IPU.
6
Shut down Windows.
7
Turn the Main Unit switch OFF.
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Transmitted light intensity
Change in
transmitted light
Clotting timet
100 %
0 %
50 %
2.5 Analysis principles
This instrument warms a fixed quantity of sample for a certain time period before adding reagents.
The following processes are analyzed based on the change in the transmitted light emitted from the sample with
added reagent.
Analysis method Analysis process
Clotting method Blood coagulation process (turbidity changes when fibrinogen is
transformed into fibrin)
Chromogenic method Process of color emission by a chromogenic synthetic substrate (light
absorbance change)
Immunoassay method Process of antibody-sensitive reagent in an antigen antibody reaction
(light absorbance change)
The clotting method determines the clotting time using the percentage detection method.
The chromogenic and immunoassay methods determine the change in light absorbance per minute (dOD/min) using
either the rate method or the VLin method.
Coagulation point detection method (percentage detection method)
The clotting method detects the clotting time using the percentage detection method.
The level of transmitted light intensity that is present right after the reagent is added but before clotting has
started is defined as 0 %, and the level of transmitted light intensity that is present after clotting is completed is
defined as 100 %. The time that it takes for the level of transmitted light intensity to reach the preset detection
percentage is found from the reaction curve. This is defined as the clotting time. (In the diagram below the
detection percentage is set to 50 %).
This method allows determination of the clotting time even on those specimens demonstrating only a slight
change in transmitted light intensity.
The clotting time can thus be detected using samples that show small amounts of transmitted light intensity (low
fibrinogen samples) or even samples whose speed of change is only slight (samples with extended clotting
time).
Rate method
2-22
Between the set start time and end time, the transmitted light data is analyzed and linear regression is used to
find the amount of change in light absorbance per minute.
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Change in light absorbance
(real)
Concentration or activity percent
(real)
VLin method
Under the set conditions, the start point and end point are set that will give the maximum change in absorbance
and the best linear approximation for each sample. Between the start and end, transmitted light data is analyzed
and linear regression used to find the change in light absorbance per minute.
Calibration Curves
A linear relationship exists between the activity percent or concentration (X-axis) and the clotting time (clotting
method) or change in light absorbance (chromogenic method, immunoassay method) (Y-axis) when both
parameters of analysis results are plotted on a graph. This instrument makes use of this relationship to create
calibration curves.
The axes of the calibration curves can be set as shown below.
• Log - log linear approximation (or polygonal line)
• Log - real (real - log) linear approximation (or polygonal line)
• Log - reciprocal (reciprocal - log) linear approximation (or polygonal line)
• Real - real linear approximation (or polygonal line)
• Reciprocal - Reciprocal linear approximation (or polygonal line)
• Real - reciprocal (reciprocal - real) linear approximation (or polygonal line)
Calibration curve for clotting method
Clotting time
(log)
Concentration or activity percent
(log)
Calibration curve for chromogenic method/immunoassay method
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Caution!
Photodiode
Sample
Optical fiber
FilterLight source (halogen lamp)
Calculation of PT ratio and INR value
This instrument can calculate ratios by entering normal values.
For reagents provided with an ISI (International Sensitivity Index), input the ISI to calculate the INR
(International Nomalized Ratio).
For PT
PT ratio = analyzed PT value / mean normal PT value (geometric mean)
INR = (PT ratio)
ISI
ISI values for Prothrombin Time assays must be entered directly as they appear on the current
reagent labeling. Any changes of setting values for reagent lot, software upgrades, major
servicing, etc., require verification of the ISI value.
Entering an incorrect ISI value will cause incorrect International Normalized Ratio (INR) results.
Multi-wavelength transmitted light detection method
Light from the light source is separated into 340 nm, 405 nm, 575 nm, 660 nm and 800 nm components by 5
filters. Separated light is directed to the detector wells by optical fibers. In each detector well, the light shines on
a cuvette containing a sample in which the collected sample and reagents are mixed. Light which has been
transmitted through the sample is detected. This transmitted light is converted into an electrical signal, which is
processed by a microcomputer to find the clotting time and the change in light absorbance (dOD/min).
The wavelengths used, the evaluation methods (percentage detection method, rate method), whether or not to
perform a prozone check, mixing conditions during measurement and other conditions are set, and performed in
the same detector well for 3 analysis methods (clotting, chromogenic and immunoassay).
Since multiple-wavelengths can be evaluated, a sample with an analysis error in the main wavelength is
evaluated with the sub-wavelength. This function makes it easy to obtain analysis data that is difficult to evaluate
with the main wavelength only, such as samples affected by physiological inhibitors and samples with insufficient
change in coagulation reaction strength.
The detector has the following components:
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Multi-wavelength based detector unit
HL detection system
HL detector
575 nm
660 nm
800 nm
Lamp unit
Loaded primary sample
Hemoglobin
Lipid
Bilirubin-C
Absorbance Abs
4.000
3.000
2.000
1.000
0.000
575 nm 660 nm 800 nm
300 400 500 600 700 800
Wavelength/nm
Absorption spectrum
Relationship between absorbance and interfering substances
575 nm 660 nm 800 nm
Hemolysis + - -
Lipemia + + +
+ affected
- not affected
HL-check wavelengths affected by each
interference substance
HL wavelength and calculation methods
The HL reader performs an initial check of untreated samples relative to hemolysis, and lipemia. A photometer
in the HL reader checks the presence and the type (H or L) of interference in the sample.
The HL check is performed by optical measurement of the untreated, and undiluted samples aliquots that are
processed in normal mode. No additional sample volume is needed and there is no impact on the sample
throughput or to the sample testing process.
HL detection system
The HL check system requires 100 µL or more of plasma and a cuvette. Absorbance measurements at 575, 660
and 800 nm are used to classify interferences into a negative or positive judgment before ordered sample
measurement begins. If the absorbance is greater than any of the criteria, the flag is displayed on the [Joblist]
and [Browser Main] screens based on the setting of the system.
Absorbance value of interfering substances
Depending on the assay method, a chemical or its metabolite may affect the measurement results in the
presence of high turbidity, hemolysis, bilirubin, etc. in the plasma. The figure below shows the relation between
the absorption spectrum of each interference substance and 3 wavelengths (575, 660, 800 nm) used for the
sample quality check. Hemolysis (Hem) and lipemia (Lip) are checked based on the logic of a combination of the
data of 3 wavelengths.
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2.6 Basic actions of the instrument
This instrument performs analysis using its mechanical, hydraulic and electrical systems.
The basic flow of analysis is as follows:
(1) Samples in the sample racks are carried to the aspiration position by the sampler.
(2) The sample dispensing probe aspirates the required amount of sample from the aspiration position into
cuvettes on the instrument, where the HL measurement is performed, if activated.
The sample taking into the instrument is placed in cuvettes and retained until analysis is complete.
These samples are used for automatic re-analysis and redilution analysis.
(In micro-sample mode, samples are not stored inside the instrument, and no HL measurements are
performed. These samples are directly diluted or measured.)
(3) Samples aspirated by the sample dispensing probe are diluted or measured, and then dispensed into the
cuvettes.
(4) The sample-containing cuvettes are warmed in the incubator for a certain time period.
(5) The reagent probe aspirates a certain amount of the prescribed reagent.
The reagent is warmed in the reagent probe for a certain time period.
(6) The sample that was warmed in the incubator is carried to the reagent dispensing position by the sample
catcher, and the reagent in the reagent probe is added.
(7) The sample to which the reagent has been added is mixed by the catcher and then carried to the
detector, where an analysis simultaneously starts. The detector irradiates the sample. The reaction in the
sample is detected by the change in transmitted light.
(8) The cuvettes of samples that have been analyzed are transported to the cuvette trash box by the catcher.
(9) When the analysis is completed, the samples aspirated are transported by the catcher to the cuvette
trash box for disposal.
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Inspect before turning power ON.
Turn ON the power.
Prepare for analysis.
Set the reagent/detergent/buffer. Replenish cuvettes.
➤
P.2-37 “2.7.3 Setting the reagent/detergent/buffer”
➤ P.2-61 “2.7.4 Replenishing cuvettes”
Set SB Cuvettes
(cuvettes containing stir bars).
Prepare samples.
➤ P.2-63 “2.7.5 Setting SB Cuvettes (cuvettes
containing stir bars)”
➤ P.2-74 “2.7.7 Preparing samples”
Create calibration curves.
Perform QC analysis.
Analyze samples.
Check analysis results.
2.7 Preparing for analysis
This section explains the preparations of reagents and samples that are necessary before starting analysis.
2.7.1 Overview
Analysis preparation process
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[Reagent] screen
Operation
panel
Reagent holder display
switch buttons
Reagent table status
indicator area
Reagent holder information display area
Holder No.
Sequence
Reagent name
Remaining reagent
volume
No Calibration Curve
QC Priority
2.7.2 [Reagent] screen
The [Reagent] screen checks where the reagents are set, and their status of use.
How to display the [Reagent] screen
• Press the [Reagent Information] icon on the menu screen.
• Press the [Reagent] button on the toolbar.
2-28
Reagent table status indicator area The status of the reagent set on the reagent table is displayed.
When a reagent holder is selected, the outline turns blue.
Reagent holder display Information for the reagent set in the holder is displayed as follows:
The reagent holder with a mixing function is displayed with a brown
outline.
Holder No. The holder number is displayed. The holder number consists of
rack number + “-” + holder number. Nothing is shown if no rack is
set.
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Reagent holder display examples Remaining reagent
volume
• Remaining volume
unknown
• The Main Unit is not
connected.
Reagent remaining
(remaining volume is
displayed visually in 4
levels)
Remaining volume
warning
(The remaining volume
warning that triggers a
warning depends on the
reagent volume set for 1
test under [Remaining
reagent volume] in the
[Reagent Master
Registration] dialog box.
(➤ P.4-45 “Chapter 4:
4.3.1 [Reagent Master
Registration] dialog box”))
Reagent empty
Gray
Dark gray
Pale
blue
Dark
gray
Pale blue
Yellow
Red
Sequence If multiple units of the same reagents are set at the same time, this
indicates the sequence in which they will be used. The reagent to
be used first has 1 mark, the second 2 marks, and the third 3
marks. The reagents to be used fourth or later do not have any
marks displayed.
To change the usage sequence, press [Change/Add] on the
operation panel and reset the reagents. The reset reagent
becomes the last item in the usage sequence.
Reagent Name Reagent name is displayed. However, nothing is shown if no
reagent vial is set.
Remaining reagent
volume
The remaining reagent volume is as shown below:
QC Priority If [QC Priority] is checked in [Edit Reagent Info.], the [QC] mark is
No Calibration Curve If no validated calibration curve is present, the [CAL] mark is
CS-2500 Instructions for Use
Revised March 2020
displayed. When QC analysis is performed on reagent vials marked
for QC priority, the [QC] mark is removed.
displayed.
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(Red) (Red) (Red) (Yellow)
(Yellow)
Reagent rack
color
Status
Light blue A reagent rack can be removed or a new
reagent rack can be set.
Yellow If [Change/Add] on the operation panel is
pressed during analysis, the reagent rack is
moving to the replacement position.
No color (same
as background
color)
During analysis, all reagent racks are in this
state.
Display of errors Analysis cannot be started if a reagent holder carries any of the
Warning display The reagent holder below is displayed if the remaining stable time
following error marks.
(➤ P.2-45 “Chapter 2: 2.7.3.1 Setting the reagent/detergent/
buffer” step 13)
of the reagent set on the reagent table falls below the set time.
(➤ P.2-38 “Chapter 2: 2.7.3.1 Setting the reagent/detergent/
buffer”)
Status of the reagent rack The status of the reagent rack is indicated by colors.
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[Elap. Time] is displayed.
[Usable Vol.] is displayed.[No. of Tests] is displayed.
Remaining stable time is displayed.
Reagent holder display switch buttons The display below the reagent holder switches depending on which
reagent holder display switch button you press.
Reagent holder information display
area
[Holder] tab Displays the information on the reagent set in the holder.
Holder No. Displays the holder number of the selected reagent holder.
[Reagent] Displays the name of the reagent set in the selected holder.
Displays the information on the selected reagent holder.
Pressing the [Holder] tab or the [Tests] tab switches the displayed
information.
If no reagent vial is set in the selected reagent holder, only the
holder number is displayed and all other items are blank. If no
reagent rack is set, the holder number is not displayed.
However, there is no display if no reagent vials are set, or if a
reagent other than control, calibrator, or factor is set in a
specialized reagent rack for SLD mini cups (rack number: C-1,
C-2).
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Note:
• The sequence for the usage of reagents is determined in the order of setting
the reagents. If the date and time of reagent setting are the same, the
reagent closer to the expiration date is given priority. If the reagents have the
same expiration date, the reagent set in the smaller holder number is given
priority.
• The reagent usage order can be changed by the following method if there is
a reagent that should be used with priority, etc.
1. On the [Reagent] screen, select the holder you want to edit the usage
order for from the reagent table status indicator area.
2. Press [Edit Reagent Info.] on the operation panel.
The dialog box below will appear.
3. Move the cursor to the [Seq.] field, then select the usage order from the
list that is displayed.
4. Press [OK].
The dialog box closes, and the usage order changes.
* If [QC Priority] is checked, the reagent is used first for QC analysis,
regardless of the usage order setting. However, the [QC Priority]
setting is not available for Auto QC analysis.
Note:
The number of digits displayed for the usable reagent volume follows the
conditions below.
Display to the second decimal place: If an SLD mini cup is used and the
usable volume is 1.0 mL or less
Display to the first decimal place: Cases other than above
[Seq.] If multiple units of the same reagents are set at the same time, this
indicates the sequence in which they will be used.
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[Usable Vol.] Displays the remaining volume of the usable reagents. If multiple
units of the same reagents are set at the same time, total remaining
volume will be displayed. However, this is blank if the remaining
volume is not known.
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Note:
The number of remaining tests is displayed if the [Display of No. of Tests]
checkbox is checked in the [Reagent Master Registration] dialog box. If it is not
checked, the display is [-].
(
➤ P.4-45 “Chapter 4: 4.3.1 [Reagent Master Registration] dialog box”)
[No. of Tests] The number of tests remaining is displayed. If multiple units of the
same reagents are set at the same time, the number of tests is
calculated based on the total volume. However, this is blank if the
remaining reagent volume is not known.
[Mixing] Indicates whether or not the reagent mixer is used.
[Lot No.] Displays the reagent lot number.
[Container] Displays the reagent vial type.
[Exp. Date] Displays the expiration date of the reagent.
[Set Date] Displays the date when the reagent was set.
The set date is updated when the [Change] button is pressed after
changing the reagent.
[Set Time] Displays the time when the reagent was set.
The set time is updated when the [Change] button is pressed after
changing the reagent.
[Elap. Time] The elapsed time since the reagent was set is displayed.
The elapsed time is reset when the [Change] button is pressed
after changing the reagent.
[Change] If the volume display of the reagent holder shows “Reagent
finished”, the [Change] button is displayed when that reagent
holder is selected.
When the [Change] button is pressed, the volume display changes
to “Remaining volume unknown” and dispensing becomes
possible.
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No. of tests display area
Remaining buffer and
detergent volume
display area
Information
Usage of rinse solution may be increased for some assay groups, so
set an ample volume of rinse solution.
Bar graph
color
Status
Pale blue Warning number of tests
*1
< Number of tests
Yellow Warning number of tests
*1
≥ Number of tests
Gray
*2
Remaining volume unknown
[Tests] tab The following 2 areas display the information.
No. of tests display
area
[Assay Group] Displays the assay group names.
[Tests] Displays the number of tests that can be analyzed for each assay
The number of tests that can be analyzed using the reagents set on
the reagent table is displayed for each assay group.
* A gray background is displayed for assay groups in which any of
the reagents necessary for analysis is not on the reagent table.
group. If multiple units of the same reagents are set at the same
time, the number of tests is calculated based on the total volume.
The bar graph displayed on the right shows the number of
remaining tests, and the color changes according to the status of
the reagents on the reagent table as follows.
*1: Warning number of tests: The number of tests which display an
error message informing that the reagent is running short.
If multiple reagents are used, the one with the largest warning
number of tests is used for judgment.
*2: The pale blue/yellow bar graph is displayed with gray stripes if
the remaining volume is unknown for some reagents.
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Chapter 2 Principles of Operation
Bar graph
color
Status
Pale blue Warning number of tests*1 < (remaining
volume/volume used per test)
Yellow Warning number of tests*1 ≥ (remaining
volume/volume used per test)
Gray
*2
Remaining volume unknown
Remaining buffer and
detergent volume
display area
[Reagent
Name]
[Usable Vol.
(mL)]
Operation panel Displays function buttons related to the [Reagent] screen.
1st page
[Change/Add] Changes or adds the reagent. Pressing this button moves the
[Edit Reagent Info.] Used for editing or manually entering the information on the
[Lot Group Settings] (➤ P.2-59 “Chapter 2: 2.7.3.9 Specifying the reagent lot to use”)
[Measurement Remaining
Reagent Volume]
CS-2500 Instructions for Use
Revised March 2020
Displays the remaining volume of buffer and detergent. Use the
[Customize] button on the operation panel to set the buffer and
detergent you want to display.
* The buffer/detergent that is not set on the reagent table/buffer
table is displayed in gray background.
Displays the name of the buffer/detergent that is set on the reagent
table/buffer table.
Displays the remaining volume of buffer and detergent. If multiple
units of the same buffer/detergent are set at the same time, total
remaining volume will be displayed.
The bar graph displayed on the right shows the remaining volume,
and the color changes according to the status of the buffer/
detergent as follows:
*1: Warning number of tests: The number of tests which display an
error message informing that the buffer/detergent is running
short.
*2: The pale blue/yellow bar graph is displayed with gray stripes if
the remaining volume is unknown for some buffers/detergents.
reagent rack to the replacement position under the reagent cover
for removal.
(➤ P.2-119 “Chapter 2: 2.8.9.1 Replacing and adding reagents/
detergents”)
(➤ P.2-121 “Chapter 2: 2.8.9.2 Replenishing buffers”)
reagent set on the reagent table.
(➤ P.2-54 “Chapter 2: 2.7.3.6: ● Manually entering reagent
information”)
Measures the unknown remaining volume of the reagent.
The dialog box on
the right appears
when this button
is pressed.
Press [OK] to start
the measurement.
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Chapter 2 Principles of Operation
(Yellow)
A reagent holder for which a lot number has
not been registered in the reagent lot master
can be selected and the reagent information
can be edited collectively. See below for
information about editing methods.
(➤ P.2-58 “Chapter 2: 2.7.3.8 In case of a
reagent whose lot number is not registered
in the reagent lot master”)
(Red)
A reagent holder for which the barcode
reading fails after the reagent has been set
can be selected, and the selected holders
can be collectively reset to the status of the
reagents being replaced and registered.
See below for error correction methods.
(➤ P.2-54 “Chapter 2: 2.7.3.6 In case of a
reagent barcode reading error”)
(Red background)
A reagent holder for which the reagent
expired after being set can be selected, and
the selected holders can be collectively
reset to the status of the reagents being
replenished and registered.
[Select holders] Collectively selects multiple reagent holders that are in the
following condition: With no remaining reagent volume, with a
reagent reading barcode error occurring, or with the reagent ID not
being registered in the reagent lot master.
The dialog box on
the right appears
when this button
is pressed.
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2nd page
Common to the 1st and 2nd pages
[Customize] Customizes the buffers and detergents displayed in the remaining
[Print] Prints the reagent information list. Pressing this button displays the
[More] If the operation panel comprises multiple pages, use this button to
[Close] The [Reagent] screen closes.
buffer and detergent volume display area of the [Tests] tab.
Pressing this button displays the [Customize] dialog box.
(➤ P.4-170 “Chapter 4: 4.7.6 Customizing the [Reagent] screen”)
[Confirmation] dialog box. Press [Print] to print the list.
switch between pages.
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Caution!
Information
2.7.3 Setting the reagent/detergent/buffer
Set the reagent/detergent/buffer.
Transfer any reagent that needs to be placed in another reagent vial before setting. Also, attach the reagent
evaporation cap and cover ring.
• When you use a barcode label, make sure to use the reagent, vial and adapter corresponding
to it.
The type of the reagent and information of the vial are described in the barcode.
• Use specified reagent vials. If a non-specified reagent vial is used, the reagent cannot be
correctly aspirated.
(
➤ P.1-22 “Chapter 1: 1.5.5 Usable reagent vials”)
• Use the correct adapter for your reagent vial. If the correct adapter is not used, the reagent
cannot be aspirated correctly and may cause a probe to crash resulting in an aspiration error.
See below for correct adapters.
(
➤ P.1-25 “Chapter 1: 1.5.7 Reagent vials and appropriate adapters”)
• Opening and closing the reagent table covers in an environment with high humidity may cause
condensation on the covers. Use a dry cloth to wipe off any condensation which appears on
the reagent table covers. If condensation is left on the covers for long periods, it can drip into
the reagents, resulting in incorrect analysis results.
• Set the reagent vial at the position where the barcode label is seen clearly from the slit of the
reagent rack and the adapter. If the position shifts, the barcode might not be able to be read.
• CA CLEAN I is used for rinsing the probe, so analysis is not possible if it is not set. Always
check that CA CLEAN I is set in place before starting analysis.
• CA CLEAN I must be set in at least 1 position on the reagent table A or B.
• When analysis is completed, cap the CA CLEAN I and CA CLEAN II vials on the reagent
racks.
• Do not leave the rinse solution with its lid off. It may not be possible to obtain accurate analysis
results if the lid falls off.
• When analyzing an assay group that requires cleaning with CA CLEAN II, set CA CLEAN II
on reagent table A.
• Depending on the operational environment, CA CLEAN II may be required for rinsing after
analysis. For details, contact your local service representative.
• Do not place more than the specified volume of reagent in the reagent vial.
If there is too much reagent, the error message [The liquid level of vial is too high.] may be
issued.
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Note:
Caution!
Caution!
2.7.3.1 Setting the reagent/detergent/buffer
Set the reagent/detergent on the reagent table and buffer on the buffer table.
Reagent vials are prelabeled with reagent barcodes.
Reagent barcodes contain information such as reagent lot number and vial type. The reagent
information can be set automatically by reading the barcode into the instrument.
1 Prepare the reagent/detergent/buffer required for analysis.
Prepare a sufficient volume of reagent/detergent/buffer for analysis by taking the extra volume into
consideration.
• See below for information about reagent which require transfer.
(➤ P.2-46 “Chapter 2: 2.7.3.2 Reagents requiring transfer”)
• The usable reagent vials used and their extra volumes are stated below.
(➤ P.1-22 “Chapter 1: 1.5.5 Usable reagent vials”)
When measuring the remaining reagent volume, also set the detergent necessary for analysis,
such as CA CLEAN I. If there is not enough detergent, the measurement of remaining reagent
volume will be interrupted.
2
Attach the reagent cap and cover ring, if necessary.
(➤ P.2-47 “Chapter 2: 2.7.3.3 Attach the reagent cap and cover ring”)
Before measuring the remaining reagent volume or performing an analysis, remove the reagent
vial lids. If you measure the remaining reagent volume or perform an analysis without removing
the vial lids, an error message [Insufficient Reagent (Reagent Arm Probe Crash) (“Reagent”)]
will appear.
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Warning!
Caution!
Note:
Light shield lid
Reagent
section lid
Reagent table cover A
Reagent table cover B
Reagent table cover C
Reagent table cover B openable LED
Reagent table cover A openable LED
3
Open the light shield lid/reagent section lid.
When reaching into the inside of the instrument with the light shield lid/reagent section lid open,
always check that the lid is fully open. If it is not, the light shield lid/reagent section lid could fall
down, injuring the user’s head or elsewhere.
It is also possible to open only the reagent section
lid, and set reagents and detergent.
4
Open the reagent table cover.
When removing table cover C, be sure to remove reagent table covers A and B first. Failure to do
so may cause damage to reagent table covers A and B.
When the status display of the instrument is [Ready], and the reagent table cover LED is lit
green, you can open all the reagent table covers (A, B, C) and place reagents inside.
When opening the reagent table cover,
make sure that the reagent table cover
LED is green.
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Caution!
Lock lever
Adapter
Reagent
vial
Reagent rack (6 holes)
Reagent racks (2 holes)
Reagent
vial
Reagent rack (6 holes)Reagent racks (2 holes)
• When no adapter is used • When an adapter is used
Remove reagent table covers A and B,
then remove reagent table cover C.
Slide the lock levers for reagent table
covers A and B in the arrowed
directions, to unlock them, then lift
them up.
5
Set the reagent/detergent in the reagent rack.
• Do not insert the accessory adapter in the wrong orientation. Otherwise, it would get stuck in
the reagent rack.
If you have inserted the accessory adapter in the reverse orientation and it is stuck in the
reagent rack, refer to “Troubleshooting”. (
• Push the adapter and reagent vial all the way in to make sure there is no space between the
adapter and reagent rack.
If it is not pushed all the way in, it may damage the reagent table cover, or reagent rack or the
reagent may not be aspirated correctly, resulting in incorrect analysis results.
➤ P.8-2 “Chapter 8: 8.2 When you suspect an error”)
• If there is a gap between the reagent vial and reagent rack, or if you use the provided vials (sample cup 4 mL),
insert the applicable accessory adapter between the reagent vial and reagent rack. See below for information
about adapters applicable to reagent vials.
(➤ P.1-25 “Chapter 1: 1.5.7 Reagent vials and appropriate adapters”)
• Set the reagent vial at the position where the barcode label is seen clearly from the slit of the reagent rack and
the adapter.
* Use the appropriate reagent cap (CC907148, AS143226, etc.) for reagent vials.
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Caution!
Note:
Reagent rack (6 holes)
Reagent racks (2 holes)
Table guides of
reagent table B
Table guides of
reagent table A
Table guide (small)
Table guide (right side)
6
Set the reagent rack on the reagent table.
• Do not set more than 1 reagent rack with the same number in 1 instrument.
Otherwise, the reagent information cannot be read correctly.
• Push the reagent rack all the way in to make sure there is no space between the reagent rack
and reagent table.
If it is not pushed all the way in, it may damage the reagent table cover, or reagent rack or the
reagent may not be aspirated correctly, resulting in incorrect analysis results.
• Place the reagent rack (6 holes) between the
table guides of the reagent table A (outside).
• Place the reagent rack (2 holes) between the
table guides of reagent table B (inside).
• Place the racks to the inside of the instrument
by turning the reagent table by hand to move
it forward. Five reagent racks can be set on
each reagent table A and B.
• Set CA CLEAN I in at least 1 position on the
reagent table A or B.
* The 50 mL CA CLEAN I container can only
be set on reagent table A.
CS-2500 Instructions for Use
When setting the reagent rack at position
No. 5 on the reagent table A, align the rack
between the table guide on the right and
the small table guide, as shown in the
diagram.
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Caution!
STAT/buffer table cover
STAT/buffer table
cover LED
Buffer table
Reagent vial
Adapter
7
Open the STAT/buffer table cover.
Make sure that the STAT/buffer table cover LED
is green.
8
Set the buffer on the buffer table.
• If there is a gap between the reagent vial and
• Set the reagent vial at the position where the
• Owren’s Veronal Buffer must be at room temperature before use.
If it is used while still chilled, frothing occurs during analysis, and it is likely to cause clotting
curve errors and lengthened clotting time.
• Push the adapter and reagent vial all the way in to make sure there is no space between the
adapter and reagent rack.
If it is not pushed all the way in, it may damage the STAT/buffer table cover or the buffer may
not be aspirated correctly, resulting in incorrect analysis results.
rack, or if you use the provided vials (sample
cup 4 mL), insert the applicable accessory
adapter between the reagent vial and buffer
table rack. See below for information about
adapters applicable to reagent vials.
(➤ P.1-25 “Chapter 1: 1.5.7 Reagent vials
and appropriate adapters”)
barcode label is seen clearly from the slit of
the rack and the adapter.
* Use the appropriate reagent cap
(CC907148, AS143226, etc.) for reagent
vials.
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