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Siemens Healthineers, Sysmex CA-600 Systems (Coagulation 2019)

Siemens Healthineers, Sysmex CA-600 Systems (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

Instrument name/First year sold Sysmex CA-600 Systems/2012
Number of units installed in U.S./Outside U.S. >2,500/>5,000
Number of contracts signed between 1/1/18 and 11/15/18
Country where analyzer designed/Manufactured Japan/Japan
Operational type continuous random access
Reagent type open reagent system (reconstituted manually)
Operates on whole blood or spun plasma spun plasma
Sample handling system 10-tube position sample rack
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 22.5 × 19.5 × 19.5 in./~94.6 lbs./~3.05 sq. ft.
FDA-cleared clotting-based tests PT, APTT, fibrinogen, TT, reptilase time, protein C clot, factor assays
FDA-cleared chromogenic tests Innovance AT, Berichrom AT, protein C chromo, heparin
FDA-cleared immunologic tests Innovance D-Dimer
Other FDA-cleared tests
User-defined tests in clinical use
Tests submitted for 510(k) clearance
Tests in development but not yet submitted
Methodologies supported clot detection, optical; turbidimetric, chromogenic, immunologic
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 5
Number of different assays programmed and calib. at one time 7
Number of user-definable (open) channels 7
Of those defined, number active simultaneously 5
Factor assays require manual manipulation or dilutions no
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 11/up to 200/yes (15°C)
Multiple reagent configurations supported yes
Reagents, consumables loaded without interrupting testing yes
Same capabilities when third-party reagent used yes
Maximum time same lot number of reagents can be used 12 months
Walkaway capacity: Number of specimens/Number of tests 10/50
Minimum sample volume aspirated precisely at one time 5 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity 50 µL/5 µL
Disposables used/Price of each reaction tubes, CA clean I, CA clean II, thermal paper/varies with volume
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes yes (2.7–5.0 mL)/no
Sample/Reagent barcode reading capability yes/no
Onboard test automatic inventory yes
Measures No. of tests remaining/Short sample detection yes/yes
Clot detection as preanalytical variable in plasma sample no
Auto. detects adequate reagents for aspiration and analysis yes
Hemolysis/Turbidity detection-quantitation no/yes
Dilution of patient samples onboard yes
Automatic rerun capability/Auto reflex testing capability no/no
Lag time during which hypercoagulable sample not detected yes (PT: <7 seconds; PTT: <15 seconds)
Read time extended for prolonged clotting times yes (selectable on menus)
User can set different-than-standard:
• Reagent volumes/Sample volumes yes/yes
• No. and sources of reagent yes
• Incubation times/Reading times yes/yes
Autocalib. or autocalib. alert/Multipoint calib. supported no/yes
Auto shutdown/Auto startup programmable no/no
Stat time to complete all analytes/Throughput per hour for:
• PT alone 7 minutes/60 results
• PT, PTT 8 minutes/48 results
• Fibrinogen 7 minutes/60 results
• Factor VIII activity assay
Time delay from ordering stat to aspiration of sample 2 minutes
Automatic transfer of QC results to LIS yes
Data-management capability onboard (includes QC: L-J plots)
Interface supplied by instrument vendor no
Interfaces in active user sites for: all major LIS vendors
Bidirectional interface capability yes (host query)
Results transferred to LIS as soon as test time complete yes
LOINC codes transmitted with all results no
How labs get LOINC codes for reagent kits upon request
Electronic interface available (or will be) to automated (or robotic) specimen handling system no
Modem servicing no
Time required for maintenance by lab personnel daily: <10 minutes; quarterly: <5 minutes
Onboard maintenance records no
Training provided with purchase 2 days on site, personalized education plan online training course
Approximate number of training hours needed per tech 2
List price CA-620: $42,000; CA-660: $55,000
Annual service contract cost (24/7)/Warranty with purchase
Distinguishing features (supplied by company) maximizes counter space with compact footprint in low-volume labs; increases uptime and reduces service expenses; two models to meet individual laboratory needs: CA-620 system for routine clotting-based testing, CA-660 system for clotting, chromogenic, and immunologic testing needs
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