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| Name of device/First year sold/Number of analyzers sold in 2011 | 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 to 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 |
| Laboratory: | |
| No. of different disposable reagents required to maintain device | 1 |
| Max. No. of analyte reagents that can reside in device at once | 1 |
| 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. |
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