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Siemens Healthineers, Sysmex CS-5100 System (Coagulation 2019)

Siemens Healthineers, Sysmex CS-5100 System (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

Instrument name/First year sold Sysmex CS-5100 System/2016
Number of units installed in U.S./Outside U.S. 75/1,000
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 (liquid, lyophilized, reconstituted manually)
Operates on whole blood or spun plasma spun plasma
Sample handling system continuous loading capped and uncapped 10-tube position primary sample rack × 10
Model type floor standing
Dimensions (H × W × D)/Weight/Instrument footprint 50.4 × 40.6 × 45.3 in./612.9 lbs./12.8 sq. ft.
FDA-cleared clotting-based tests PT, APTT, fibrinogen, factors II, V, VII, VIII, IX, X, XI, XII, protein C, lupus, factor V Leiden, TT, batroxobin time
FDA-cleared chromogenic tests Innovance Antithrombin, protein C, Innovance Heparin
FDA-cleared immunologic tests Innovance D-Dimer, Innovance free protein S antigen, factor VIII chromogenic, plasminogen
Other FDA-cleared tests
User-defined tests in clinical use
Tests submitted for 510(k) clearance
Tests in development but not yet submitted von Willebrand factor, a2-antiplasmin
Methodologies supported clot detection, optical; turbidimetric; clot detection, simultaneous multiwavelength scanning and PSI checks; chromogenic; immunologic
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 60
Number of different assays programmed and calib. at one time 60
Number of user-definable (open) channels 80,000
Of those defined, number active simultaneously 60
Factor assays require manual manipulation or dilutions no
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 40/up to 200/yes (10°C ± 2°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 1 year
Walkaway capacity: Number of specimens/Number of tests 100/up to 1,000
Minimum sample volume aspirated precisely at one time 5 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity 50 µL/—
Disposables used/Price of each reaction tubes, CA clean I and II/—
Supports direct-from-track sampling yes (Siemens Aptio Automation)
Primary tube sampling supported/Pierces caps on primary tubes yes (1–4.5 mL)/yes
Sample/Reagent barcode reading capability yes/yes
Onboard test automatic inventory yes
Measures No. of tests remaining/Short sample detection yes/yes
Clot detection as preanalytical variable in plasma sample yes
Auto. detects adequate reagents for aspiration and analysis yes
Hemolysis/Turbidity detection-quantitation yes/yes
Dilution of patient samples onboard yes
Automatic rerun capability/Auto reflex testing capability yes/yes
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 yes/yes
Auto shutdown/Auto startup programmable no/no
Stat time to complete all analytes/Throughput per hour for:
• PT alone 6.5 minutes/400 results
• PT, PTT 6.5 minutes/400 results
• Fibrinogen 6.5 minutes/—
• Factor VIII activity assay
Time delay from ordering stat to aspiration of sample 1 minute
Automatic transfer of QC results to LIS yes
Data-management capability onboard (includes QC: L-J plots and Westgard multirules)
Interface supplied by instrument vendor no
Interfaces in active user sites for: most major vendors
Bidirectional interface capability yes (broadcast download and 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
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: <6 minutes; weekly: 1 minute; monthly: <1 minute
Onboard maintenance records yes
Training provided with purchase 3 days at vendor offices; varies on site
Approximate number of training hours needed per tech 6
List price $205,000
Annual service contract cost (24/7)/Warranty with purchase —/1 year
Distinguishing features (supplied by company) confidence: simultaneous multiwavelength detection and PSI technology designed to ensure high-quality first-run results; operational efficiency: user-friendly software on Windows 7, tilted reagent vials and point-in-space automation ready; consistency: for multisite patient monitoring, with sample result traceability for in-depth audit capabilities
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