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Nova Biomedical, Stat Profile pHOx Ultra

Nova Biomedical, Stat Profile pHOx Ultra

In vitro blood gas analyzers, May 2017

Contact Information

Nova Biomedical
200 Prospect St.
Waltham, MA 02454-9141

Name of device/First year sold/Number of analyzers sold in 2016 Stat Profile pHOx Ultra/2011/—
Number of devices sold in U.S./Outside U.S./List price
Dimensions (H x W x D)/Weight 17.2 × 22.3 × 18.7 inches/61 pounds
Analytes measured on device pH, PCO2, PO2, Hct, Hb, Na, K, CI, iCa, iMg, lactate, glucose, creatinine, BUN, SO2%, bilirubin, CO-oximetry
Parameters calculated on device BE, TCO2, HCO3-
Barometric pressure tracked
Analytical method(s) or technologies employed pH, iCa, iMg, Na, CI, and K: direct ISE; PCO2: Severinghaus; PO2: amperometry; Hct: conductivity; Hb, SO2%: optical–reflectance; lactate, glucose, and creatinine: enzyme/amperometric
Device is part of a series of related models yes (pHOx analyzer series, pHOx Ultra without CO-ox)
Device warranty/Loaner devices provided 1 year/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
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 1
Max. No. of analyte reagents that can reside in device at once 20
Shelf life of components reagents and electrodes: 18 months; membrane kits: 12–24 months
Cost per test/Reagent cost per test depends on volume/—
Calibrations required 1 and 2 point (automatic)
Calibration frequency 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 3, 4, 5, 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 reports, true liquid quality control
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/aspiration and capillary
Sample size for complete panel of analyte results 210 µL
Sample size differs with number of analytes selected yes, variety of micropanel options offered and can be customized from 60 to 210 μL
Time from sample introduction to result availability up to 134 seconds
Max. No. of patient samples per hour/Max. No. measured results per hour 26/520
Optimal throughput when analyzer calibrated, awaiting specimens 23 per hour
Calibration can be interrupted to perform stat sample yes
Known interferences none
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 multilevel password with unique user ID number (customizable)
Instrument response for:
• hardware failure/software failure self-diagnosis software informs and notifies operator, hotline, and field support of hardware and software failures
• 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 barcode scanning is provided operator and patient identifiers
Built-in printer/Data port yes/RS-232, Ethernet, others
Information listed on hard copy report patient ID with accession numbers, entered settings, measured and calculated results
Analyzer connections data-management system or directly to LIS/HIS, or both
Interface standards supported ASTM 1394 and 1238, HL7, POCT1-A
How analyzer connects to external system to upload patient and QC results hospital network
Information included in transmission from analyzer to external system device-unique identifier, operator and patient IDs, results, QC identifier
Hardware and software for data-management system full-featured onboard DMS capability, external DMS also available
No. of different management reports system produces >30
Contents downloaded from data-management system to analyzer valid control values and operator IDs, patient demographics
System connected (live installations) to which LISs, HISs
Use a third-party interfacing tool, engine for LIS, HIS interfaces yes
Distinguishing features (supplied by company) 20-test whole blood critical care menu and proven platform of hybrid component cartridge-based biosensor technology; BUN, iMg available exclusively; analyzer networking at no extra cost; multiple pHOx Ultra analyzers can be networked together into a single, common database; a supervisor or authorized operator can access all patient results, QC results, and reports from all analyzers
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.