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CAP TODAY Product Guides



Name of device/First year sold/Number of analyzers sold in 2012 epoc Blood Analysis System/2008/—
Number of devices sold in U.S./outside U.S./List price —/—/$7,500
Dimensions (H x W x D)/Weight 3 × 3.4 × 8.5 inches/~1.5 pounds
Analytes measured on device pH, pCO2, p02, Na+, K+, Ca++, glucose, Hct, lactate, Crea, CI-
Parameters calculated on device cHCO3, cTCO2, BE(ecf), BE(b), cS02, cHgb, eGFR, eGFR-a, AGap, AGapK
Barometric pressure recorded
Analytical method(s) or technologies employed pH, iCa, pC02, Na, K: potentiometry; p02, lactate, glucose: amperometry; Hct: conductometric; Hb: calculated
Device is part of a series of related models no
Device warranty/Loaner devices provided 1 year, extended warranty available/—
Average life expectancy of device
Open or closed system/External gas tanks required closed/no
Categorized for point-of-care testing or laboratory point-of-care testing
Point of care:
Disposable prepackaged system used for analysis reagent/electrode (single use)
No. of disposable reagent system units in standard package 50
No. of samples analyzed per one disposable reagent, electrode system 1
Reagent unit storage requirements room temperature
Shelf life of disposable units up to 6 months
Laboratory:
No. of different disposable reagents required to maintain device
Max. No. of analyte reagents that can reside in device at once
Shelf life of components
Cost per test/Reagent cost per test
Calibrations required 1 point (automatic)
Calibration frequency every test
Internal QC program recommended
QC features/Capabilities of QC features
Remote control of device from laboratory yes
System can use LOINC to transmit results to LIS yes
Specimen types suitable for device whole blood, capillary, mixed venous, arterial, venous
Acceptable anticoagulants/Sampling technique heparin/injection, capillary transfer and fill
Sample size for complete panel of analyte results ~92 mL
Sample size differs with number of analytes selected no
Time from sample introduction to result availability ~35 seconds
Maximum No. of patient samples per hour/Maximum No. measured results per hour
Optimal throughput when analyzer calibrated, awaiting specimens
Calibration can be interrupted to perform stat sample no
Known interferences
Sampler has self-wiping probe no
Time required for maintenance by lab personnel
Service center performs diagnostics through modem no
Method of analyst ID in system
Instrument response for:
• hardware failure/software failure error code, rejection of card/error code, rejection of card
• QC failure failure noted on final report
• calibration failure card rejected
For what bar-code scanning is provided operator and patient IDs, reagent lot number, all open fields
Built-in printer/Data port no/—
Information listed on hard copy report all
Analyzer connections LIS/HIS, via data management system
Interface standards supported HL7
How analyzer connects to external system to upload patient and QC results real-time wireless (RF)
Information included in transmission from analyzer to external system device-unique identifier, operator and patient IDs, results, QC identifier, others
Hardware and software for data management system software only
No. of different management reports system produces customizable
Contents downloaded from data management system to analyzer valid operator IDs, others
System connected (live installations) to which LISs, HISs most
Use a third-party interfacing tool, engine for LIS, HIS interfaces yes, Mirth
Distinguishing features (provided by company) room-temperature card storage (up to six months); bar-coded test cards for quality and inventory management; fully wireless data transfer to data manager, real time (no need to dock for download)
Note: a dash in lieu of an answer means company did not answer question or question is not applicable *FDA 510k cleared
Tabulation does not represent an endorsement by the College of American Pathologists.