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Specifications CAPITULO 1 PDF
Specifications CAPITULO 1 PDF
1.2.1 Name
AUTOMATED BLOOD COAGULATION ANALYZER
1.2.2 Model
CA-1500
1.3.1 Configuration
(1) Configuration
1) Main Unit
2) Pneumatic Unit (built-in type)
3) Sampler Unit (loading max. 5 racks (50 sample tubes))
(2) Options
1) Sample ID Bar Code Reader (built-in type)
Sample ID numbers can be automatically read by the bar code reader (BCR5342-TI), which
can scan the samples in one rack and the STAT sample.
2) Reagent ID Bar Code Reader (hand-held type)
Wand bar code reader can be connected to read the bar code attached on the reagent
container. This can also be used to register the sample ID of STAT samples.
3) Page Printer
Prints out analysis results. (BJ-410J or equivalent)
4) Laser Printer
Prints out analysis results. (LaserJet5L or equivalent)
5) Ticket Printer
Prints out analysis results. (DP-510 or equivalent)
6) Cap Piercing Unit (built-in type)
NOTE: The page printer and laser printer cannot be simultaneously connected.
This unit measures the coagulation of the plasma component of anti-coagulant (sodium citrate)
added human blood. Only FDP analysis include serum test.
1.4.2 Performance
(4) Accuracy
When control plasma N is measured consecutively 10 times, measurement error of the average
time (second) should lie within the following ranges. (The ambient temperature must be 25 ±
10°C.
PT: ± 8 % or less
APTT: ± 8 % or less
(5) Reproducibility
Coefficient of variation, when control plasma N for 1) ~ 9) and standard plasma of 10 ~ 30 µg/mL
concentration for 10), 11) are measured consecutively 10 times, should fall within the following
ranges:
1) PT, APTT [ second ] CV 2 % or less
2) TTO, NT [ second ] CV 4 % or less
3) Fbg [ second ] CV 4 % or less
4) Factor determination [ second ] CV 5 % or less
5) TT [ second ] CV 10 % or less
6) AT-III [ second ] CV 5 % or less
7) PLG [ second ] CV 5 % or less
8) a2PI [ second ] CV 5 % or less
9) PC [ second ] CV 5 % or less
10) FDP [ µg/mL ] CV 10 % or less
11) D-Dimer Plus [ µg/L ] CV 10 % or less
Advanced D-Dimer [ mg/L ] CV 10 % or less
12) PCc [%] CV 6% or less
13) Heparin [ IU/mL ] CV 5 % or less
14) F VIII CH [%] CV 5 % or less
2) Stability within-a-day
Variation of measurement at the time of 2, 4 and 8 hours from that at 30 minutes after the
power is turned on (initial value) falls within the following ranges. The ambient temperature
at the time of measurement should be within the specified range. Temperature variation
must be within 5°C.
(Measurement after 2, 4 or 8 hours) - (Measurement at 30 minutes)
x 100
(Initial value)
PT, APTT [ second ] ± 5 % or less
Fbg, TTO, NT [ second ] ± 10 % or less
AT III [%] ± 10 % or less
Additionally, approximately 28 mL of distilled water and approximately 400 µL (at the maximum) of rinsing
solution (CA CLEAN) are required for rinsing per test.
1.4.3 Functions
(1) Sample Tube Transportation Function
Sample tube is transported from the feeder unit to the sample incubation unit by the Slide
Catcher Method.
14 mm 700 µL -----
14 mm 500 µL -----
Sample Cup Closed 100 µL -----
Open 50 µL -----
3) Reanalysis mode is not available as the dispensed sample is for one test only.
When the sample is in the STAT holder it is possible to program the reanalysis, but when the
sample is in a sample rack it is impossible to analyze the sample as the rack is already
shifted.
4) Reflect test is not assigned, as the Reflect key on the work list entry screen is not available.
5) Micro-sample measurement is not possible for the sample in the closed collection tube, as
multiple sample aspiration is not possible.
6) “Test on hold” setting in the Alarm Setting is not effective and the analysis is automatically
interrupted by the reagent shortage.
The instrument specification performance described in this section are obtained using the following
reagents.
(1) PT measurement: Thromboplastin C plus
Thromboplastin IS
Dade INNOVIN
Thromborel S
(2) APTT measurement: Data-Fi APTT
Data-Fi APTT(FS)
Actin FSL
Pathrontin SL
20 mM Calcium Chloride Solution
25 mM Calcium Chloride Solution
(3) Fbg measurement: Data-Fi Fibrinogen Thrombin
(4) Buffer: Owren's Veronal Buffer
(5) Control plasma: Dade Ci-Trol Level I, II, III
Dade Control Plasma N, P
(6) TTO measurement: CA Series Complex Factor TTO
(7) NT measurement: CA Series Complex Factor NT
(8) TT measurement: Data-Fi Thrombin Time
(9) AT III measurement: Dade Antithrombin III Kit
(10) a2PI measurement: Dade a 2-Antiplasmin Kit
(11) PLG measurement: Dade Plasminogen Kit
(12) PC measurement: Dade Protein C Kit
(13) FDP measurement: Lpia FDP (Daiayatron Co., Ltd.)
(14) D-Dimer measurement: Dade D-Dimer Plus
Dade Advanced D-Dimer
(15) PCc measurement: Protein C Reagent, coagulometric
(16) Heparin measurement: Berichrom Heparin
(17) F VIII CH measurement: Factor VIII chromogenic assay