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Helena Laboratories, Cascade M-4 (Coagulation 2019)

Helena Laboratories, Cascade M-4 (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

Helena Laboratories
David Pearman
Beaumont, TX
409-842-3714 ext. 265

Instrument name/First year sold Cascade M-4/1992
Number of units installed in U.S./Outside U.S. 200+/40
Number of contracts signed between 1/1/18 and 11/15/18 5
Country where analyzer designed/Manufactured U.S./U.S.
Operational type random access
Reagent type open reagent system
Operates on whole blood or spun plasma spun plasma
Sample handling system manual
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 8 × 15 × 13 in./25 lbs./1.4 sq. ft.
FDA-cleared clotting-based tests PT, APTT, fibrinogen, TCT, factor assays II, V, VII–XII
FDA-cleared chromogenic tests
FDA-cleared immunologic tests
Other FDA-cleared tests
User-defined tests in clinical use PT, APTT, fibrinogen, TCT, factor assays II, V, VII–XII
Tests submitted for 510(k) clearance
Tests in development but not yet submitted DRVVT
Methodologies supported clot detection, optical; turbidimetric
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 4
Number of different assays programmed and calib. at one time 4
Number of user-definable (open) channels 4
Of those defined, number active simultaneously 2
Factor assays require manual manipulation or dilutions yes
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 0/—/no
Multiple reagent configurations supported no
Reagents, consumables loaded without interrupting testing no
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
Minimum sample volume aspirated precisely at one time manual, 50 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity 100 µL, minimum 50 µL/100 µL (diluted), minimum 50 µL (diluted)
Disposables used/Price of each cuvettes: 500 @ $54; pipette tips: 1,000 @ $82
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes no/—
Sample/Reagent barcode reading capability no/no
Onboard test automatic inventory no
Measures No. of tests remaining/Short sample detection no/no
Clot detection as preanalytical variable in plasma sample
Auto. detects adequate reagents for aspiration and analysis no
Hemolysis/Turbidity detection-quantitation no/no
Dilution of patient samples onboard no
Automatic rerun capability/Auto reflex testing capability no/no
Lag time during which hypercoagulable sample not detected yes (PT: 4 seconds; PTT: 14 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 3 minutes/140 specimens
• PT, PTT 7 minutes/80 specimens
• Fibrinogen 3 minutes/160 specimens
• Factor VIII activity assay 7 minutes/80 specimens
Time delay from ordering stat to aspiration of sample
Automatic transfer of QC results to LIS yes
Data-management capability no
Interface supplied by instrument vendor no
Interfaces in active user sites for:
Bidirectional interface capability no
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: 10 minutes; weekly: 10 minutes; monthly: 30 minutes
Onboard maintenance records no
Training provided with purchase 1 day on site
Approximate number of training hours needed per tech 2
List price $10,115
Annual service contract cost (24/7)/Warranty with purchase $1,291/1 year
Distinguishing features (supplied by company) 4-channel manual analyzer, QC program onboard, singles or duplicates
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.