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Nova Biomedical, Stat Profile pHOx (In vitro blood gas 2013)

Nova Biomedical, Stat Profile pHOx (In vitro blood gas 2013)

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Contact Information

Nova Biomedical
200 Prospect Street
Waltham, MA 02454-9141

Name of device/First year sold/Number of analyzers sold in 2012 Stat Profile pHOx/1998/—
Number of devices sold in U.S./outside U.S./List price
Dimensions (H x W x D)/Weight 15 × 12 × 15 inches/18 pounds
Analytes measured on device pH, PCO2, PO2, Hct, Hb, SO2%
Parameters calculated on device BE, TCO2, HCO3-
Barometric pressure tracked
Analytical method(s) or technologies employed pH: direct ISE; PCO2: Severinghaus; PO2: amperometry; Hct: conductivity; Hb and SO2%: optical–reflectance
Device is part of a series of related models yes
Device warranty/Loaner devices provided 1 year, travel and labor, repair, or replacement/yes
Average life expectancy of device 5–7 years
Open or closed system/External gas tanks required closed/no
Categorized for point-of-care testing or laboratory point-of-care testing and laboratory
Point of care:
Disposable prepackaged system used for analysis reagent
No. of disposable reagent system units in standard package 200–500
No. of samples analyzed per one disposable reagent, electrode system
Reagent unit storage requirements room temperature
Shelf life of disposable units reagents: 18 months at room temperature; electrodes: up to 18 months
No. of different disposable reagents required to maintain device one
Max. No. of analyte reagents that can reside in device at once one
Shelf life of components reagents and electrodes: 18 months; membrane kits: 12–24 months
Cost per test/Reagent cost per test <$0.11 at 35 analyses per day/<$0.08 at 35 analyses per day
Calibrations required 1 and 2 point (automatic)
Calibration frequency 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 4, or 6 hours (user defined)
Internal QC program recommended minimum CLIA recommendations
QC features/Capabilities of QC features L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager)
Remote control of device from laboratory no
System can use LOINC to transmit results to LIS no
Specimen types suitable for device whole blood, capillary, mixed venous, arterial
Acceptable anticoagulants/Sampling technique heparin/aspiration and capillary
Sample size for complete panel of analyte results 70 µL
Sample size differs with number of analytes selected yes, standard 3-test blood gas micro-panel sample required is 45 µL
Time from sample introduction to result availability 45 seconds
Maximum No. of patient samples per hour/Maximum No. measured results per hour 300/300 tests
Optimal throughput when analyzer calibrated, awaiting specimens 300 tests per hour
Calibration can be interrupted to perform stat sample yes
Known interferences
Sampler has self-wiping probe yes
Time required for maintenance by lab personnel weekly: <5 minutes; monthly: <10 minutes
Service center performs diagnostics through modem yes
Method of analyst ID in system password with unique user ID number (optional)
Instrument response for:
• hardware failure/software failure self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support
• QC failure options range from flagging to not re­port­ing test to lockout for QC failure or exceeding scheduled QC interval
• calibration failure any test that does not calibrate will not report results and instrument notifies operator of reason for failure
For what bar-code scanning is provided patient ID
Built-in printer/Data port yes/multiple RS-232
Information listed on hard copy report patient ID with accession number, entered settings, measures and calculates results
Analyzer connections data-management system or directly to LIS/HIS, or both
Interface standards supported ASTM E1381-91 and ASTM 1394-91 (HL7 available with external device)
How analyzer connects to external system to upload patient and QC results direct serial/>500 hospitals institutions; hospital network/>100 institutions
Information included in transmission from analyzer to external system device-unique identifier, operator and patient IDs, results, QC identifier, accession number
Hardware and software for data management system Pentium with Microsoft Windows 2000/Nova Point-of-Care Manager
No. of different management reports system produces >60
Contents downloaded from data management system to analyzer yes, patient name, passwords
System connected (live installations) to which LISs, HISs
Use a third-party interfacing tool, engine for LIS, HIS interfaces yes
Distinguishing features (provided by company) onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.