Edition:11-3
Chapter 1 Specifications
1.1
Overview ................................................................................................................................1
1.2
Naming...................................................................................................................................1
1.2.1
1.2.2
Model names .........................................................................................................................1
Model .....................................................................................................................................1
1.3
Classification ..........................................................................................................................1
1.4
Shape, configuration and dimensions ....................................................................................1
1.4.1
1.4.2
1.4.3
1.4.4
1.4.5
1.5
Configuration and extensibility to the system.........................................................................1
Electrical rating ......................................................................................................................2
Appearance, dimensions, and weight ....................................................................................3
Components and their functions ............................................................................................6
Principle of Analysis ...............................................................................................................6
Performance, intended use, and other specifics ....................................................................7
1.5.1
1.5.2
1.5.3
1.5.4
1.5.5
1.5.6
1.5.7
1.5.8
1.5.9
1.6
Purposes (intended use) ........................................................................................................7
Analysis parameters and displayed items..............................................................................7
Analysis range .......................................................................................................................8
Analysis time ..........................................................................................................................9
Reproducibility .......................................................................................................................9
Accuracy ................................................................................................................................9
Stability ................................................................................................................................10
Analysis mode and sample throughput ................................................................................11
Required volume of plasma and reagent .............................................................................12
Functions..............................................................................................................................15
1.6.1
1.6.2
1.6.3
1.6.4
1.6.5
1.6.6
1.6.7
1.6.8
1.6.9
1.6.10
1.6.11
1.6.12
1.6.13
1.6.14
1.6.15
1.6.16
1.6.17
1.6.18
1.6.19
1.6.20
1.7
CS-1600 S/M
Cuvette transporter ..............................................................................................................15
Automatic cuvette supplier ...................................................................................................15
Sample and reagent dispenser ............................................................................................15
Liquid level detector .............................................................................................................15
First-level sample aspirator ..................................................................................................16
Sampler function ..................................................................................................................17
Reagent installation function ................................................................................................19
Sample incubation function ..................................................................................................20
Detection function ................................................................................................................20
Probe rinsing function ..........................................................................................................20
Agitator.................................................................................................................................20
Memory storage function .....................................................................................................21
User interface.......................................................................................................................21
Printing .................................................................................................................................21
QC function ..........................................................................................................................22
Calibration curve function ....................................................................................................22
Abnormality warning function ...............................................................................................22
Automatic re-analysis function .............................................................................................23
Protective function ...............................................................................................................23
Language .............................................................................................................................24
Noise ....................................................................................................................................24
January 2015
Edition:11-3
1.8
Conditions of Use.................................................................................................................25
1.8.1
1.8.2
1.8.3
1.8.4
1.9
Operating environment ........................................................................................................25
Power supply (electrical rating) ............................................................................................25
Grounding ............................................................................................................................25
Usable reagent.....................................................................................................................25
Operating methods...............................................................................................................29
1.10 Maintenance Method............................................................................................................30
1.10.1 Supplies ...............................................................................................................................30
1.11 Storage conditions, transportation conditions ......................................................................30
CS-1600 S/M
January 2015
Chapter 1 Specifications
1.1
(1)
(2)
Overview
This instrument, a successor to the CA-1500, is a full automatic coagulation analyzer targeted at
low-end and mid-range markets that can perform coagulation, chromogenic (synthetic substrate),
and immunoturbidimetric analysis. The instrument is equipped with a cap-piercing unit (hereinafter
referred to as "CP").
The instrument inherits the cost competitiveness of the CA-1500 as its successor model while
improving the operability of the CA-1500 by being built on the hardware of the CA-1500 but
leveraging the technologies (multi-wave sensing) from the CS-2000i/2100i and CS-5100. In
addition, to allow for future growth of the coagulation business, the instrument comes with
instrument, reagent, consumable, and other specifications that differentiate it from competitors.
1.2
Naming
1.2.1
Model names
Automated Blood Coagulation Analyzer CS-1600
1.2.2
Model
CS-1600
1.3
Classification
General medical device (Class I)
1.4
Shape, configuration and dimensions
1.4.1
Configuration and extensibility to the system
(1)
Components
1) Analyzing unit (the model with CP)
2) Sampler (up to 10 samples can be accommodated in a single sample rack, and up to 5 sample racks can be installed)
3) LCD touchscreen (10.4 inch)
4) Data processing unit (on-board PC with Windows Embedded Standard 7)
5) Built-in pneumatic unit
6) Accessories: Instructions for Use, power cord, etc.
(2)
Extensibility to the system (peripheral devices)
1) 2D barcode reader and dedicated rack
2) Externally connected printer
CS-1600 S/M
1-1
January 2015
3)
4)
5)
6)
7)
8)
9)
10)
(3)
Waste tank (20 L, 10 L)
Float switch for waste tank
External pneumatic unit PU-17 (for high elevation areas)
Reagent lid tray
Reagent cap S and reagent cap L
Trash box liner
SLD mini Cup
SLD micro Cup
Extensibility to the system (software)
1) Host computer connection
2) SNCS connection
1.4.2
(1)
(2)
(3)
(4)
Electrical rating
Rated input voltage: 100 to 240 V
AC or DC:
AC
Power frequency:
50 Hz or 60 Hz
Power consumption
Rated input
voltage
100 V
120 V
220 V
230 V
240 V
(5)
Protection type:
CS-1600 S/M
Frequency
50 Hz
60 Hz
50 Hz
60 Hz
50 Hz
60 Hz
680 VA or less
50 Hz
60 Hz
50 Hz
60 Hz
Class I device/Type B device
1-2
January 2015
1.4.3
(1)
Appearance, dimensions, and weight
Appearance and construction
Stop switch
Front view
Main power switch
Right side view
CS-1600 S/M
1-3
January 2015
Left side view
Rear view
Incubator, detector
Left side view
Top view
CS-1600 S/M
1-4
Sampler
January 2015
Reagent arm unit
Catcher unit
Sample arm unit
System control unit
Front view
Right side view
Rear view
(2)
Dimensions
Width
Approx. 760 mm
Height
Approx. 540 mm
Depth
Approx. 690 mm
(3)
Weight
Approx. 85 kg
CS-1600 S/M
1-5
January 2015
1.4.4
Components and their functions
(1)
Main power switch
Turns ON/OFF the power.
(2) Catcher unit
Transports cuvettes.
(3) Sample/reagent arm unit
Dispenses a required amount of sample/reagent.
(4) Stop switch
Pauses the instrument.
(5) Incubator
Incubates (warms) the sample as well as the sample and reagent mixture.
(6) Detector
Measures the clotting time or the amount of change in light absorbance by detecting changes in
turbidity or light absorbance.
(7) Temperature control unit
Controls the temperatures of the detector, sample incubator, reagent incubator probe, and cooling
unit.
(8) System controller
Provides system control of the instrument.
(9) Drive circuit
Controls the drive of each motor.
(10) Sampler
Enables automatic continuous analysis. Up to 5 sample racks can be installed at once. A single
rack can accommodate up to 10 sample tubes.
1.4.5
(1)
(2)
(3)
Principle of Analysis
Dispensing of sample
The instrument dispenses a prescribed amount of a diluted or non-diluted sample into the reaction
containers (cuvettes) dedicated to the respective analysis parameters. It can accept a plasma or
serum sample obtained by centrifuging intravenous blood treated with anticoagulant as well as a
urine sample.
Analysis
1) In coagulation analysis, the instrument radiates a light to a plasma and reagent mixture and
detects changes in transmitted light to obtain the amount of changes in turbidity that occur
when fibrinogen is transformed into fibrin.
2) In chromogenic (synthetic substrate) analysis, the instrument radiates a light to a plasma and
reagent mixture and detects changes in transmitted light to obtain the amount of changes in
light absorbance that occur during the chromogenic reaction of a chromogenic synthetic substrate.
3) In immunoturbidimetric analysis, the instrument radiates a light to a mixture of plasma, serum,
or urine and reagent, and detects changes in transmitted light to obtain the amount of changes
in light absorbance that result from the latex agglutination reaction due to antigen-antibody
complex reaction.
Data analytics
The instrument analyzes the reaction curve derived from the changes in the amount of transmitted
light, thereby computing the necessary analysis values.
CS-1600 S/M
1-6
January 2015
(4)
Output of the results
Analysis results (analysis values, reaction curve, and flag information) are reported on the LCD
monitor and can be printed through an external printer.
1.5
Performance, intended use, and other specifics
1.5.1
Purposes (intended use)
The instrument is intended for analyzing the coagulation characteristics and fibrinolytic capacity of the
plasma of human blood mixed with an anti-coagulant (sodium citrate). For FDP analysis, however, the
instrument can be used to analyze plasma, serum, and urine samples.
1.5.2
(1)
Analysis parameters and displayed items
(Units are indicated in [ ])
Coagulation analysis
1) Prothrombin time (PT) [sec.]
Computed parameters: PT activity [%], PT ratio [-], PT-INR[-], Derived fibrinogen (dFbg) concentration [mg/dL]
2) Activated partial thromboplastin time (APTT) [sec.]
Computed parameter: APTT ratio [-]
3) Fibrinogen (Fbg) [sec.]
Computed parameter: Fbg concentration [mg/dL]
4) Complex factor thrombotest (TTo) [sec.]
Computed parameters: TTo activity [%], TTo-INR[-]
5) Complex factor hepaplastin test (HpT) or normo test (NT) in certain countries [sec.]
Computed parameters: HpT activity [%] (NT activity [%]), HpT-INR[-] (NT-INR[-])
6) Thrombin time (TT) [sec.]
7) Extrinsic factor activity assay (II, V, VII, X) [sec.]
Computed parameters: extrinsic factor activity assay (II, V, VII, X) volume [%]
8) Intrinsic factor activity assay (VIII, IX, XI, XII) [sec.]
Computed parameters: intrinsic factor activity assay (VIII, IX, XI, XII) volume [%]
9) Lupus anticoagulant
Lupus anticoagulant screening (LA1) [sec.]
Lupus anticoagulant confirmation (LA2) [sec.]
Computed parameter: LA ratio [-]
10) Protein S Ac (PS Ac) [sec.]
Computed parameter: Ps Ac activity [%]
11) Protein C (PC-cl) [sec.]
Computed parameter: PC-cl activity [%]
12) TT Thorombocrotin (TT-TCL) [sec.]
13) Batroxobin time (BXT) [sec.]
14) Protein C global PCAT (PCAT) [sec.]
15) Factor V Leiden (FV Leiden) [sec.]
CS-1600 S/M
1-7
January 2015
(2)
Chromogenic method
1) Antithrombin III (AT-III) [dOD/min.]
Computed parameter: AT-III activity [%]
2) Protein C (PC) [dOD/min.]
Computed parameter: PC activity [%]
3) α2-Plasmin inhibitor (α2-Pl) [dOD/min.]
Computed parameter: α2-Pl activity [%]
4) Plasminogen (Plg) [dOD/min.]
Computed parameter: Plg activity [%]
5) Coagulation factor VIII [FVIII] [dOD/min.]
Computed parameter: FVIII activity [%]
6) BC C1-Inhibitor (BC-C1) [dOD/min.]
Computed parameter: BC C1-Inhibitor activity [%]
7) Heparin (Hep) [dOD/min.]
Computed parameter: heparin concentration [IU/mL]
(3)
Immunoassay method
1) D-Dimer [dOD/min.]
Computed parameters: D-Dimer concentration [µg/mL], [µg/L], [FEU]
2) Fibrin degradation product (FDP) [dOD/min.]
Computed parameter: FDP concentration [µg/mL]
3) Urinary fibrin degradation product (U-FDP) [dOD/min.]
Computed parameter: U-FDP concentration [µg/mL]
4) Von Willebrand factor antigen level [dOD/min.]
Computed parameter: VWF:Ag antigen level [%]
5) Soluble fibrin monomer complex (FM) [dOD/min.]
Computed parameter: FM concentration [µg/mL]
6) Plasmin/plasmin inhibitor complex (PIC) [dOD/min.]
Computed parameter: PIC concentration [µg/mL]
7) Free protein S (FPS) [dOD/min.]
Computed parameter: Free protein S antigen [%]
8) Von Willebrand factor (vWF:Ac) [dOD/min.]
Computed parameter: vWF:Ac activity [%]
1.5.3
Analysis range
The instrument provides the following analysis ranges when available reagents are used:
(1) Fibrinogen (Fbg)
ThromboCheck Fib, Fib(L): 30mg/dL~1400mg/dL
(However, fibrinogen levels 700 mg/dL or above require a 20x dilution and fibrinogen levels 50 mg/
dL or below require a 5x dilution)
Data-Fi/Fibrinogen: 30mg/dL~900mg/dL
(However, fibrinogen levels 450 mg/dL or above require a 20x dilution and fibrinogen levels 80 mg/
dL or below require a 2.5x dilution)
(2)
D-Dimer
RIAS Auto D-Dimer Neo (wide range): 0.5 µg/dL to 100 µg/dL
CS-1600 S/M
1-8
January 2015
1.5.4
Analysis time
Detection time for each parameter: max. 1800 sec.
1.5.5
Reproducibility
When a normal control sample (or abnormal control sample [D-Dimer], [FDP], or [PIC]) is analyzed 10
times consecutively, the parameters will fall within the following ranges at a reliability factor of 95%:
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
PT (sec.)
APTT (sec.)
Fbg (sec.)
TTo (sec.)
HpT (sec.)
TT (sec.)
Extrinsic factor activity assay (II, V, VII, X) (sec.)
Intrinsic factor activity assay (VIII, IX, XI, XII) (sec.)
LA1 (sec.), LA2 (sec.)
AT-III (%)
PC (%)
α2-PI (%)
Plg (%)
F.VIII (Chromogenic) (%)
D-Dimer (µg/mL), (µg/L), (FEU)
FDP (µg/mL)
VWF:Ag (%)
PIC (µg/mL)
FM (µg/mL)
1.5.6
Standard value
C.V. 2% or less
C.V. 2% or less
C.V. 4% or less
C.V. 4% or less
C.V. 4% or less
C.V. 10% or less
C.V. 5% or less
C.V. 5% or less
C.V. 4% or less
C.V. 5% or less
C.V. 5% or less
C.V. 5% or less
C.V. 5% or less
C.V. 5% or less
C.V. 10% or less
C.V. 10% or less
C.V. 5% or less
C.V. 10% or less
C.V. 10% or less
Accuracy
When a normal control sample is analyzed 10 times consecutively, the displayed values of the
parameters will fall within the following ranges of deviation from the average:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
PT (sec.)
APTT (sec.)
Fbg (mg/dL)
Extrinsic factor activity assay (%)
Intrinsic factor activity assay (%)
AT-III (%)
D-Dimer (µg/mL)
CS-1600 S/M
5% or less
5% or less
10% or less
10% or less
10% or less
10% or less
10% or less
1-9
January 2015
1.5.7
(1)
Stability
Temperature stability
When a normal control sample (or abnormal control sample [D-Dimer]) is analyzed 10 times consecutively, the difference between the value analyzed at environment temperatures of 20 to 25°C,
C23, and the values analyzed before and after the temperature changes from 15°C to 30°C, C15
and C30, given by the equation
C15 (or C30) - C23
x 100
C23
will fall within the following ranges:
1) PT, APTT (sec.)
2) AT-III (%)
3) D-Dimer (µg/mL)
(2)
5% or less
10% or less
10% or less
Stability over time (diurnal variation)
When a normal control sample (or abnormal control sample [D-Dimer]) is analyzed 10 times consecutively, the difference between the value analyzed 30 minutes after power-on (the initial value)
and each of the values analyzed 2 hours, 4 hours, and 8 hours after power-on, given by the equation
(Values analyzed at 2 hours, 4 hours, and 8 hours later) - (Initial value)
(Initial value)
will fall within the following ranges:
1) PT, APTT (sec.)
2) AT-III (%)
3) D-Dimer (µg/mL)
x 100
5% or less
10% or less
10% or less
It is, however, assumed that the environment temperatures at the time of analysis are within the
working temperature range specified in the Conditions of Use and that the difference between the
high and low temperatures is within 5°C.
(3)
Stability across days (day-to-day variation)
When a normal control sample (or abnormal control sample [D-Dimer]) is analyzed 10 times consecutively, the difference between the average over the test period of 5 days and each of analysis
values obtained during the test period, given by the equation
(Analyzed value) - (Average)
(Average)
x 100
will fall within the following ranges:
1) PT, APTT (sec.)
5% or less
2) AT-III (%)
10% or less
3) D-Dimer (µg/mL)
10% or less
It is, however, assumed that the environment temperatures at the time of analysis are within the
working temperature range specified in the Conditions of Use and that the difference between the
high and low temperatures is within 5°C.
CS-1600 S/M
1-10
January 2015
(4)
Power supply stability
When a normal control sample (or abnormal control sample [D-Dimer]) is analyzed 10 times consecutively, the difference between the value analyzed at the rated voltage and the value analyzed
when the voltage is 90% or 110% of the rated voltage, given by the equation
(Value analyzed at 90% or 110%) - (Value analyzed at 100%)
(Value analyzed at 100%)
will fall within the following ranges:
1) PT, APTT (sec.)
2) AT-III (%)
3) D-Dimer (µg/mL)
1.5.8
(1)
x 100
5% or less
10% or less
10% or less
Analysis mode and sample throughput
Analysis Mode
1) Normal mode
In this mode, the instrument takes in, at once, as much sample as required for all the analyses, including any re-analyses, from a sample tube placed on the sample rack and then dispenses the sample on an analysis by analysis basis before analyzing the sample.
2) Micro mode
In this mode, the instrument takes in as much sample as required for an individual analysis
from a sample tube placed on the sample rack or reagent cooling unit every time it is about to
analyze the sample.
(2) Sample throughput (as measured after the initial results are obtained)
1) PT single parameter analysis
approx. 120 tests/h
2) PT, APTT simultaneous analysis
approx. 110 tests/h
3) PT, APTT, Fbg, D-Dimer simultaneous analysis approx. 70 tests/h
CS-1600 S/M
1-11
January 2015
1.5.9
Required volume of plasma and reagent
The following table describes the amount of sample plasma required for each analysis parameter and the
amount of reagent required for the analysis of a single sample:
(Unit: µL)
(1) Coagulation analysis
Sample
volume
Buffer
volume
50
-
50
-
Fibrinogen
10
Thrombotest
Analysis parameter
Prothrombin time
Other reagents
used
Reagent
volume
PT
100
APTT
50
CaCl2
50
90
Fbg
50
20
30
TTO
125
Hepaplastin test
10
40
HpT
125
Thrombin time (Test Thrombin)
50
-
Test Thrombin
100
Extrinsic factor activity assay
(II, V, VII, X)
5
45
Factor-deficient
plasma
50
PT
100
Factor-deficient
plasma
50
APTT
50
CaCl2
50
Activated partial thromboplastin time
Intrinsic factor activity assay
(VIII, IX, XI, XII)
10
40
Lupus anticoagulant
Screening
100
-
Lupus anticoagulant
Confirmation
100
-
25
177
5
45
Protein S
Protein C
Batroxobin time
50
-
50
-
Protein C global
Factor V Leiden
10
Thrombin time (Thromboclotin)
CS-1600 S/M
40
100
-
1-12
LA1
LA2
100
100
PSAc Reagent
58
PSAcAct
145
PCAct
50
PC APTT
50
CaCl2
50
Batrox
100
ActProC/BufProC
50
APTTReag
50
CaCl2
50
ActProC/BufProC
50
APTTReag
50
CaCl2
50
Thromboclotin
100
January 2015
(2)
Chromogenic method
Sample
volume
Buffer
volume
(Berichrom)
21
147
(ELSYSTEM)
10
166
Analysis parameter
Antithrombin III
(INNOVANCE Antithrombin)
α2-Plasmin inhibitor
(Berichrom)
150
21
147
(ELSYSTEM)
16
144
(Berichrom)
21
147
Plasminogen
(ELSYSTEM)
Protein C
14
16
159
15
15
Coagulation factor VIII
15
C1 Inhibitor
165
50
150
Heparin
20
CS-1600 S/M
-
1-13
Other reagents
used
Reagent
volume
Thrombin Reagent
175
Substrate Reagent
33
Enzyme solution
100
Substrate solution
30
Antithrombin Reagent
70
Substrate Reagent
70
Plasmin Reagent
175
Substrate Reagent
35
Enzyme solution
130
Substrate solution
50
Streptokinase Reagent
175
Substrate Reagent
35
SK solution
140
Substrate solution
50
Protein C Activator
150
Substrate Reagent
30
Factor X Reagent
40
Factor IXa Reagent
40
Substrate Reagent
120
C1Reag E
200
C1 Subs
25
AT3 Reagent
20
Factor Xa Reagent
170
Substrate Reagent
40
January 2015
(3)
Immunoassay method
Analysis parameter
Fibrin degradation product
(Latex test P-FDP)
Sample
volume
Buffer
volume
21
147
(Latex test S-FDP)
16
156
(U-FDP)
22
(RIAS Auto P-FDP)
11
10
150
D-Dimer
(RIAS Auto D-Dimer Neo)
6
14
(INNOVANCE D-Dimer)
15
Von Willebrand factor
Antigen level (low)
Von Willebrand factor
Antigen level (medium)
Plasmin/plasmin inhibitor complex
Soluble fibrin monomer complex
15
55
-
15
15
21
157
16
112
Free protein S
21
150
Von Willebrand factor
Activity (low)
70
CS-1600 S/M
-
1-14
Other reagents used
Reagent
volume
Latex test BL-2 P-FDP
Dilution stabilizer
94
Latex test BL-2 P-FDP
Latex
94
Latex test BL-2
hematuria FDP reagent
1 (serum, urine)
110
Latex test BL-2
hematuria FDP reagent
2 (serum, urine)
50
Latex test BL-2
hematuria FDP reagent
1 (serum, urine)
88
Latex test BL-2
hematuria FDP reagent
2 (serum, urine)
55
P-FDP buffer solution
84
P-FDP latex solution
84
RIAS Auto D-Dimer
reagent 1
84
RIAS Auto D-Dimer
reagent 2
84
INNOVANCE D-Dimer
Supliment
20
INNOVANCE D-Dimer
Buffer
72
INNOVANCE D-Dimer
Reagent
66
Buffer solution
60
Latex solution
90
Buffer solution
60
Latex solution
90
PIC buffer solution
120
Latex solution
30
Buffer solution
35
Latex solution
140
INNOVANCE Free PS
Ag Reagent
60
INNOVANCE Free PS
Ag Buffer
80
INNOVANCE vWF Ac
Reagent II
70
INNOVANCE vWF Ac
Reagent III
20
INNOVANCE vWF Ac
Reagent I
40
January 2015
Analysis parameter
Sample
volume
Buffer
volume
Von Willebrand factor
Activity (medium)
30
1.6
Functions
1.6.1
Cuvette transporter
15
Other reagents used
Reagent
volume
INNOVANCE vWF Ac
Reagent II
70
INNOVANCE vWF Ac
Reagent III
20
INNOVANCE vWF Ac
Reagent I
40
Transports the cuvettes from the feeder to the incubator and detector and discharges them from the
detector to the disposal unit.
1.6.2
(1)
(2)
(3)
Automatic cuvette supplier
Automatically supplies cuvettes via a hopper.
The number of cuvettes that can be accommodated: Up to 300
Cuvette type: For the CS series (SUC-400A)
1.6.3
Sample and reagent dispenser
Aspirates and dispenses a sample and reagent using two probes, one of which is dedicated to
dispensing a sample and the other of which is dedicated to dispensing a reagent and equipped with a
built-in incubator.
(1) Temperature control accuracy (for reagent dispensing): 37.5±0.5°C (on the assumption that the
room temperature is 15 to 30°C)
(2) Time to reach the temperature setpoint (temperature indicated above): 30 minutes Max. under the
Conditions of Use
(3) Quantification method: Syringes are used to aspirate, discharge, and wash away samples or
reagents.
(4) Quantitative syringe x 2
1.6.4
Liquid level detector
Each probe is equipped with a built-in liquid level detector that detects the liquid level of a sample or
reagent. This function causes the probe to move down below the liquid surface of a sample or reagent
and stop upon reaching a specific depth.
CS-1600 S/M
1-15
January 2015
1.6.5
(1)
(2)
(3)
(4)
First-level sample aspirator
The number of samples that can be aspirated: 250 Max. (5 sample plates, each of which has 50
holes)
Sample capacity:
500 µL Max.
Cooling function:
none
Dead volume:
(unit: µL)
Sample tube
setting
With/without
cap
Dead volume
occupied by
the sample
plate
Used for
quantitative
replenishment
Used to
suppress
dilution
Occupied
by
the piercer
Total
Default
With
30
190
BD 1.8 mL
With
35
195
BD 2.7 mL
With
30
190
VACUETTE
With
30
190
VACUETTE
Sandwich
Coagulation
Tube
With
35
195
MONOVETTE
With
30
190
Neotube
With
30
190
CS-1600 S/M
50
30
1-16
80
January 2015
1.6.6
(1)
(2)
Sampler function
Maximum number of samples that can be accommodated:50 (5 racks, each of which can
accommodate 10 samples) (additional racks can be added at any time)
Supported containers
Size
Manufacturer
BD
Greiner
Terumo
Sarstedt
Nipro
Other
containers
not listed
Sample
volume
Types
Outer
diameter
Length
[mL]
[mm]
[mm]
Vacutainer (conventional stopper)
4.5
13
75
Vacutainer (Hemogard stopper)
4.5
13
75
Vacutainer CTAD (Hemogard stopper)
4.5
13
75
Vacutainer Plus (Hemogard stopper) (double-tube type)
2.7
13
75
Vacutainer Plus (Hemogard stopper) (double-tube type)
1.8
13
75
Vacuette
4
13
75
Vacuette
3
13
75
Vacuette Sandwich Coagulation Tube (double-tube type)
3.5
13
75
Vacuette Sandwich Coagulation Tube (double-tube type)
3
13
75
Vacuette Sandwich Coagulation Tube (double-tube type)
2
13
75
Venoject II
2.7
13.2
78
Venoject II
1.8
13.2
78
Venosafe
3.6
13
75
Venosafe
2.7
13
75
Venosafe
1.8
13
75
S-Monovette
3
13
65
S-Monovette
2.9
11.5
66
Neotube
3.6
12.8
75
Neotube
2.7
12.8
75
Neotube
1.8
12.8
75
Neotube GP
1.8
12.8
75
Sample tubes with 9.4 mm or more in inner diameter
10 to 15
(9.4 to 14 in inner
diameter)
14 in inner diameter
75
or less
12 in inner diameter
9.4 in inner diameter
CS-1600 S/M
Sample Cup (4 mL)
-
-
SLD micro Cup
-
-
1-17
January 2015
(3)
(4)
Sample cooling function:
Sample ID reader:
(5)
Dead volume
none
The barcode reader (which comes standard with the instrument) can
be used to read sample IDs.
Sample
volume
[mL]
Plasma
only
With blood
cell layer
4.5
1.0 mL
11 mm
0.7 mL
7.5 mm
4.5
1.0 mL
11 mm
0.7 mL
7.5 mm
4.5
1.0 mL
11 mm
0.7 mL
7.5 mm
Vacutainer Plus (Hemogard stopper) (doubletube type)
2.7
0.5 mL
12 mm
0.5 mL
7.5 mm
Vacutainer Plus (Hemogard stopper) (doubletube type)
1.8
0.4 mL
12 mm
0.4 mL
7.5 mm
0.5 mL
12 mm
0.5 mL
7.5 mm
0.5 mL
12 mm
0.5 mL
7.5 mm
0.9 mL
11 mm
0.6 mL
7.5 mm
0.4 mL
12 mm
0.35 mL
7.5 mm
0.6 mL
12 mm
0.6 mL
7.5 mm
Manufacturer
BD
Types
Vacutainer (conventional stopper)
Vacutainer (Hemogard stopper)
Vacutainer CTAD (Hemogard stopper)
Greiner
Terumo
Sarstedt
Nipro
Other
containers not
listed
CS-1600 S/M
Vacuette
4
Vacuette
3
Vacuette Sandwich Coagulation Tube (doubletube type)
3.5
Vacuette Sandwich Coagulation Tube (doubletube type)
3
Vacuette Sandwich Coagulation Tube (doubletube type)
2
Venoject II
2.7
Venoject II
1.8
S-Monovette
3
S-Monovette
2.9
Neotube
3.6
Neotube
2.7
Neotube
1.8
Neotube GP
1.8
10 to 15 in outer diameter (9.4 to 14 in inner
diameter)
-
11 mm
7.5 mm
14 in inner diameter
-
1.2 mL
1.3 mL
12 in inner diameter
-
0.9 mL
0.9 mL
9.4 in inner diameter
-
0.6 mL
0.6 mL
Sample Cup (4 mL)
-
0.3 mL
-
SLD micro Cup
-
0.15 mL
-
1-18
January 2015
1.6.7
Reagent installation function
(1)
Number of reagents that can be installed
1) Reagent/control/calibrator/CA Clean: 28 containers Max. (with cooling)
2) Buffer: 5 containers Max. (without cooling)
For both 1) and 2) above, the same reagent can be put into more than one containers.
(2)
Supported containers
1) SIEMENS reagent vial (GW5, GW15, GW25)
2) Transfer container (sample cup 4 mL, SLD vial, SLD mini Cup, SLD micro Cup)
3) Sysmex reagent vial (SIRC3, SIRC5, SIRC17, PFDP5, CA-Clean, HBM1, HBM3, HBM5,
HBM25)
(3)
Support for reagent caps
The instrument allows the installation of reagent containers capped by reagent caps (intended to
prevent evaporation) and can perform an analysis without the necessity to remove the reagent
caps.
Containers that can be equipped with reagent caps include the following:
GW5, GW15, GW25, SIRC3, SIRC5, SIRC17, PFDP5, HBM3, HBM5, HBM25
(4)
Reagent installation method
1) Use a reagent rack to install a reagent on the reagent table.
2) Attaching an adapter compatible with certain different types of reagent containers to a reagent
rack allows those reagent containers to be installed on the reagent rack.
(5)
Dead volume
<Reagent holder (reagent/control/detergent)>
1) GW5:
0.4 mL (reagent probe)
2) GW15:
1.4 mL (reagent probe)
3) GW25:
1.4 mL (reagent probe)
4) Cup 4 mL:
0.2 mL (reagent probe)
5) SIRC3:
0.4 mL (reagent probe)
6) SIRC5:
0.4 mL (reagent probe)
7) SIRC17:
1.2 mL (reagent probe)
8) PFDP5:
0.6 mL (reagent probe)
9) SLD mini:
0.15 mL (sample piercer)
10) SLD micro:
0.15 mL (sample piercer)
11) CAClean:
7 mL (reagent probe)
12) HBM3:
0.4 mL (reagent probe)
13) HBM5:
0.4 mL (reagent probe)
14) HBM25:
1.4 mL (reagent probe)
<Buffer holder>
1) GW5:
2) GW15:
3) GW25:
4) SIRC17:
5) Cup 4 mL:
CS-1600 S/M
2.4 mL (sample piercer)
3.9 mL (sample piercer)
3.9 mL (sample piercer)
3.9 mL (sample piercer)
0.5 mL (sample piercer)
1-19
January 2015
6)
7)
8)
SLD:
CAClean:
HBM25:
0.8 mL (sample piercer)
7 mL (sample piercer)
3.9 mL (sample piercer)
(6)
Remaining reagent amount monitoring
Estimates the amount of remaining reagent based on the reagent container (bottle) information in
combination with the liquid level detected by the probe's level sensor during analysis.
(7)
Support for the installation of multiple containers containing the same reagent
The instrument allows the installation of up to 6 containers containing the same reagent.
(8)
Reagent installation time monitoring
(9)
Reagent expiration monitoring
1.6.8
Sample incubation function
(1)
Number of Incubator wells
9 wells
(2)
Temperature control accuracy
37.0±1.0°C (on the assumption that the room temperature is 15 to 30°C)
(3)
Time to reach the temperature setpoint (temperature indicated above)
30 minutes Max. under the Conditions of Use
1.6.9
Detection function
(1)
Analysis wavelength
The instrument can analyze up to 4 different transmitted light wavelengths at the same time.
(2)
Number of detection channels
8
(3)
Detection temperature
37±0.5°C (on the assumption that the room temperature is 15 to 30°C)
1.6.10
(1)
Probe rinsing function
Rinsing unit
Rinses the probe using the syringe and solenoid valve control while positive and negative
pressures are being applied to the rinse and waste champers, respectively.
1.6.11
Agitator
Agitates the plasma (serum) and reagent by vibrating the cuvettes after the reagent has been dispensed.
CS-1600 S/M
1-20
January 2015
1.6.12
Memory storage function
(1)
Data stored in memory
1) Analysis data
2) Various settings
3) QC data
4) Dates (year, month, day, hour, minute)
(2)
Memory capacity
1) Maximum number of samples whose data can be stored in memory: 3,000
1.6.13
User interface
(1)
Display
The instrument supports the display resolution of 800 x 600 pixels.
(2)
Data displayed on the monitor
1) Job lists (order registration, analysis progress, analysis results, estimated time required to
compute the results, actual time taken to compute the results)
2) Reaction curves
3) Quality control (QC data, QC diagram)
4) Calibration curves (Calibration curve data, Calibration curve diagram)
5) Reagent management information (installation, remaining amount, etc.)
6) Consumables information
7) Instrument status (instrument status, temperature/pressure information)
8) Error message, operation message
9) Various setting information
(3)
User input
The instrument accepts user input via the touchscreen.
1.6.14
Printing
(1)
Printing method
The instrument provides the ability to print out graphics through an external printer connected to it.
Printing can be initiated either manually or automatically.
(2)
Items that can be printed
1) Analysis results
2) QC results
3) Calibration curves
4) Operation log
5) Error log
6) Various setting information
CS-1600 S/M
1-21
January 2015
1.6.15
QC function
(1)
QC analysis
The instrument supports two QC analysis modes: manual and auto. In manual mode, the user
initiates QC analysis by installing a QC sample in place and manually enters an order. In auto
mode, the instrument initiates QC analysis at preset time intervals.
(2)
Number of QC files
Up to 40 files. Up to 300 points/chart, 50 charts/file.
(3)
QC check function
1) Westgard multirule
Rules that can be applied include 1-2s, 1-3s, 2-2s, 4-1s, 5-0.5s, R-4s, 7T, and 10x.
2) Control limit method
1.6.16
(1)
(2)
(3)
Number of configurable calibration curve parameters
Up to 5 reagent lot group/parameter (up to 5 calibration curves/reagent lot group)
Number of calibration curve points
2 to 9 points/calibration curve
Analysis times
An analysis can be performed up to 5 times for each point.
1.6.17
(1)
Calibration curve function
Abnormality warning function
Instrument failure monitoring
1) Pressure (pressure error)
2) Temperature (temperature error)
3) Chambers (hydraulic line error, lack of rinse water, waste tank full)
4) Motors (mechanical error)
5) Dispensing (failure to dispense sample, failure to aspirate reagent, lack of reagent, absence of
installed reagent, lack of detergent, lack of cuvettes, lack of sample plates)
6) Sampler (sampler error, rack full)
7) Analyzing unit (failure in analysis start check, detector error)
8) External I/O (host communication error)
9) QC (QC error (caution), QC error (analysis aborted))
10) User operations (operation cover open detected, stop button depressed, abnormal power-off,
operational warning)
11) Others (sensor error, PCB error, failure to remove clogs, motor driver error, barcode reader
error, fan error, cuvette trash box error, clog of cuvette supplier, lamp error, failure to read barcode, warning before running out of consumables, cycle count error, re-analysis failure, position adjustment failure, upper limit of sample aspiration)
CS-1600 S/M
1-22
January 2015
(2)
Sample and abnormal reaction monitoring
1) Coagulation curve abnormalities
2) Overreaction to antigen
3) Sample volume check
4) Analysis value error monitoring (checks for any deviations based on mark limit values, report
limits, and the results of repeated analyses)
1.6.18
Automatic re-analysis function
(1)
Automatic re-analysis
Provides the ability to automatically re-analyze the same parameter of the same sample under the
same conditions in accordance with preconfigured settings.
(2)
Automatic re-dilution analysis
Provides the ability to automatically re-analyze the same parameter of the same sample at a
different dilution ratio in accordance with preconfigured settings.
(3)
Reflex test
Provides the ability to automatically re-analyze another parameter of the same sample in
accordance with preconfigured settings, performing multi-dilution analysis as needed.
1.6.19
Protective function
(1)
Overheat protection function
Provides thermal protection to the reagent cooling unit, reagent probe (with a built-in incubator),
pneumatic unit, incubator, and detector.
(2)
Overcurrent protection function
The instrument is protected from an overcurrent by means of a function or element equivalent to a
fuse, circuit breaker, or the like.
(3)
Stop function
When the stop switch is pressed, the instrument immediately stops all active operations and turns
off the excitation of the motors.
However, it may wait for certain operations to complete before stopping them as needed to secure
user safety.
(4)
Operation cover position monitoring and locking
Monitors whether the operation cover is open or closed and locks the cover as needed to secure
user safety.
(5)
Probe protection function
The probes are all equipped with a crash sensor.
(6)
Data protection function
Provides the ability to manually or automatically save backups to external storage (such as a USB
memory stick).
(7)
Software protection function
McAfee Embedded Security is preinstalled.
CS-1600 S/M
1-23
January 2015
1.6.20
Language
Japanese, English, Chinese, German, Italian, French, Spanish, Russian
1.7
Noise
For Characteristic A, the instrument meets the following requirements when its noise level is measured in
front of it in accordance with Japanese Industrial Standards JISZ8731 (Method of Noise Level
Measurement): (The measuring point is positioned 1 m away from the front side of the product.)
(1)
(2)
Standby status:
55 dB or less
During the analysis operation: 60 dB or less
The above requirements do not take into account any sudden noise over 60 db for a duration not
exceeding 5 seconds (such as heard when cuvettes are discarded into the trash box or rinsing for
piercing is performed) and any alarm sound.
CS-1600 S/M
1-24
January 2015
1.8
Conditions of Use
1.8.1
Operating environment
(1)
(2)
(3)
(4)
Ambient temperature:
Relative humidity:
Atmospheric pressure:
Installation environment:
1.8.2
(1)
(2)
15°C to 30°C
30% to 85% (no condensation)
70 kPa to 106 kPa
avoid direct sunlight, dust, vibration, and acid.
Power supply (electrical rating)
Rated voltage
AC 100 to 240 V ±10%
Frequency
50 or 60 Hz ±1 Hz
1.8.3
Grounding
Class 3 grounding or higher
1.8.4
Usable reagent
(1)
PT analysis:
Thromborel S
ThromboCheck PT
ThromboCheck PT Plus
Dade Innovin
(2)
APTT analysis:
Data-Fi APTT
Data-Fi APTT FS
Data-Fi APTT FSL
Patorontin SL
ThromboCheck APTT
ThromboCheck APTT-SLA
Calcium chloride solution (0.025 mol/L)
Calcium chloride solution (0.02 M)
(3)
Fbg analysis:
Data-Fi Fibrinogen
ThromboCheck Fib
ThromboCheck Fib(L)
(4)
TTo analysis:
Complex factor T "Kokusai" (blue)
(5)
HpT analysis:
Complex factor H "Kokusai"
(6)
Thrombin time analysis:
Test Thrombin Reagent
Thromboclotin
CS-1600 S/M
1-25
January 2015
(7)
Factor-deficient plasma:
Siemens factor-deficient plasma II
Siemens factor-deficient plasma V
Siemens factor-deficient plasma VII
Siemens factor-deficient plasma X
Siemens factor-deficient plasma VIII
Siemens factor-deficient plasma IX
Siemens factor-deficient plasma XI
Siemens factor-deficient plasma XII
SIRC FACTOR II
SIRC FACTOR V
SIRC FACTOR VII
SIRC FACTOR X
SIRC FACTOR VIII
SIRC FACTOR IX
SIRC FACTOR XI
SIRC FACTOR XII
(8)
Lupus anticoagulant analysis:
LA1 Screening Reagent
LA2 Confirmation Reagent
(9)
Protein S (coagulation) analysis:
Protein S Ac
(10) Protein C (coagulation) analysis:
Protein C Reagent
(11) Batroxobin time analysis:
Batroxobin Reagent
(12) Protein C global analysis:
ProC Global
(13) Factor V Leiden analysis:
ProC Global
Factor V Deficient Plasma
(14) AT-III analysis:
ELSYSTEM ATIII
Berichrom Antithrombin III auto B
INNOVANCE Antithrombin
(15) PC analysis:
Berichrom Protein C
(16) α2-PI analysis:
Berichrom α2-Antiplasmin
ELSYSTEM APL
(17) PLG analysis:
Berichrom Plasminogen
ELSYSTEM PLG
(18) FVIII analysis:
Factor VIII Chromogenic Assay
(19) C1 inhibitor analysis:
Berichrom C1-Inhibitor
CS-1600 S/M
1-26
January 2015
(20) Heparin analysis:
Berichrom Heparin
(21) D-Dimer analysis:
RIAS Auto D-Dimer Neo (wide range)
INNOVANCE D-Dimer
(22) FDP analysis:
Latex test BL-2 hematuria/urine FDP
Latex test BL-2 P-FDP
RIAS Auto P-FDP
(23) Von Willebrand factor antigen level: vWF Ag reagent
(24) Soluble fibrin monomer complex:
Auto LIA FM
(25) RIAS Auto PIC:
RIAS Auto PIC
(26) Free protein S:
INNOVANCE Free PS Ac
(27) Von Willebrand factor activity:
INNOVANCE vWF Ac
(28) Detergents:
CA CLEAN I
CA CLEAN II
(29) Standard supplies/accessories:
Standard human plasma for coagulation testing
Coagtrol N
D-Dimer Standard Neo
P-FDP Standard 120
FDP Standard (for urine)
PIC standard solution
PT multi-calibrator
AK calibrant
Auto LIA FM calibrator
Fib standard plasma
Fibrinogen calibrator kit
Berichrom Heparin LMW CALIBRATOR
Berichrom Heparin UF CALIBRATOR
INNOVANCE D-Dimer CALIBRATOR
CS-1600 S/M
1-27
January 2015
(30) Control:
CS-1600 S/M
Dade Ci-Trol Control Level 1
Dade Ci-Trol Control Level 2
Dade Ci-Trol Control Level 3
Control plasma N for coagulation testing
Control plasma P for coagulation testing
Coag QAP Control IX
Coag QAP Control IIX
Coagtrol I
Coagtrol II
Coagtrol III
Fibrinolytic Control L
Fibrinolytic Control H
FDP Control (for urine)
RIAS Auto PIC control
Auto LIA FM control L
Auto LIA FM control H
LA control L
LA control H
Abnormal Fibrinogen
Berichrom Heparin LMW CONTROL 1
Berichrom Heparin LMW CONTROL 2
Berichrom Heparin UF CONTROL 1
Berichrom Heparin UF CONTROL 2
INNOVANCE D-Dimer CONTROL 1
INNOVANCE D-Dimer CONTROL 2
ProC Control plasma
1-28
January 2015
1.9
Operating methods
Inspection
before powering on
電源を入れる前の点検
Turning
on the power
電源の投入
測定試薬の準備
Preparing
analysis reagents
Checking
calibration curves
検量線の確認
Performing
quality control
精度管理の実行
Preparing
samples
検体の準備
Analysis
測定
Shutdown
シャットダウン
CS-1600 S/M
- Make sure that the rinse tank is filled with a sufficient amount of detergent.
- If the waste tank is connected, check the level of waste liquid in it and discard
any excess waste liquid.
- Make sure that the power cord is connected.
- Discarding cuvettes that are already analyzed, if any, in the trash box.
- Replenishing cuvettes.
- Replenishing sample plates.
- Turning ON the power.
- Waiting for startup of the instrument.
- Logging in.
- Preparing reagents, buffers and detergents required to execute analysis.
- Install reagent on the reagent cooling unit.
- Checking the reagent information.
- Preparing samples for QC.
- Checking calibration curves.
- Performing quality control.
- Affixing barcode labels on the sample tubes.
- Setting the sample tubes or sample cups that contain the sample in a sample rack.
- Registering analysis orders.
- Starting the analysis.
- The analysis result is displayed after the analysis is finished. As needed,
report the analysis results via printing or electronically.
- Discarding cuvettes in the trash box.
- Shutting down the instrument.
- Removing the reagents, buffers and detergents.
1-29
January 2015
1.10
Maintenance Method
1.10.1
Supplies
(1)
Reagents
As described in 1.8.4 Usable reagent
(2)
Consumables
1) Cuvette SUC-400A
2) Sample plate SAP-400A
3) Halogen lamp JB12V24WF6/SSM
4) Fuse 250V-4A-N1
5) Sample Cup 4 mL
6) SLD vial
7) Reagent cap S CSS-400A
8) Reagent cap L CSL-400A
9) Trash box liner CS1
10) SLD micro Cup
11) SLD mini Cup SLD-400A
12) Piercer
1.11
(1)
(2)
Storage conditions, transportation conditions
Storage conditions
1) Ambient temperature:
2) Relative humidity:
3) Atmospheric pressure:
-10 to 60°C
30 to 95%
70 to 106 kPa
Transportation conditions
Transportation of the instrument is subject to the conditions set forth in the Vibration Test Standard
[TE285001] and Drop Test Standard [TE285011].
CS-1600 S/M
1-30
January 2015