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Name of device/First year sold/Number of analyzers sold in 2016 | GEM Premier 3000/2000/— |
Number of devices sold in U.S./Outside U.S./List price | >10,000 worldwide/$39,995 |
Dimensions (H x W x D)/Weight | 17 × 12 × 12 inches/29.5 pounds |
Analytes measured on device | pH, pO2, pCO2, Hct, Na, K, iCa, glucose, lactate |
Parameters calculated on device | A-aDO2, pAO2, paO2/pAO2, RI, O2cap*, O2Ct*, CaO2*, CvO2*, CcO2*, a-vDO2*, Qsp/Qt, P50, HCO3-, BEb, BEcecf, tCO2c, S02c, tHbc, Ca++(7.4) |
Barometric pressure | — |
Analytical method(s) or technologies employed | pH, pCO2: potentiometry; pO2, glucose, lactate: amperometry; Hct: conductivity; Na, K, iCa: potentiometric ion-selective electrode |
Device is part of a series of related models | yes |
Device warranty/Loaner devices provided | 5 years/yes |
Average life expectancy of device | 7–10 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 | multiuse cartridge |
No. of disposable reagent system units in standard package | 1 |
No. of samples analyzed per one disposable reagent, electrode system | 35-, 75-, 150-, 300-, 450-, and 600-test cartridge |
Reagent unit storage requirements | room temperature |
Shelf life of disposable units | 6 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 multiuse cartridge |
Shelf life of components | 6 months (cartridge) |
Cost per test/Reagent cost per test | varies with size and menu/— |
Calibrations required | automated continuous with Intelligent Quality Management (iQM) |
Calibration frequency | automated continuous with iQM |
Internal QC program recommended | internal, automated, continuous quality management included |
QC features/Capabilities of QC features | onboard iQM/automated on-demand monthly reports include number of measurements, mean, maximum, and minimum delta values |
Remote control of device from laboratory | no |
System can use LOINC to transmit results to LIS | yes |
Specimen types suitable for device | whole blood, arterial, venous, mixed venous, capillary |
Acceptable anticoagulants/Sampling technique | heparin/aspiration |
Sample size for complete panel of analyte results | 135 µL |
Sample size differs with number of analytes selected | no |
Time from sample introduction to result availability | 85 seconds |
Max. No. of patient samples per hour/Max. No. measured results per hour | 20/180 |
Optimal throughput when analyzer calibrated, awaiting specimens | 20 samples per hour |
Calibration can be interrupted to perform stat sample | yes |
Known interferences | interferences detected by iQM and operator notified |
Sampler has self-wiping probe | yes |
Time required for maintenance by lab personnel | none (disposable cartridge) |
Service center performs diagnostics through modem | no |
Method of analyst ID in system | manual or barcode entry of ID and password (customizable) |
Instrument response for: | |
• hardware failure/software failure | operator warning, sampling lockout if required/operator warning, sampling lockout if required |
• QC failure | iQM will automatically detect and perform corrective actions or disable analyte if necessary |
• calibration failure | iQM will automatically detect and perform corrective actions or disable analyte if necessary |
For what barcode scanning is provided | operator and patient IDs, CVP, ContrIL values |
Built-in printer/Data port | yes/3 RS-232, 1 parallel, barcode reader port, Ethernet port |
Information listed on hard copy report | patient demographics, hospital name and address, results |
Analyzer connections | GEMweb, GEMweb Plus, Impact for Critical Care |
Interface standards supported | ASTM protocol |
How analyzer connects to external system to upload patient and QC results | direct serial, Ethernet, modem dial-in |
Information included in transmission from analyzer to external system | device identifier, operator and patient IDs, patient results, QC identifier and results |
Hardware and software for data-management system | Impact for Critical Care |
No. of different management reports system produces | customizable |
Contents downloaded from data-management system to analyzer | patient ID, demographics |
System connected (live installations) to which LISs, HISs | major HIS/LIS vendors |
Use a third-party interfacing tool, engine for LIS, HIS interfaces | MAS RALS, Telcor |
Distinguishing features (supplied by company) | iQM detects, corrects, and documents system, sensor, or sample errors, reducing error-detection time to minutes; maintenance-free single, multiuse cartridge available in customized configurations for use in any hospital location |
Note: a dash in lieu of an answer means company did not answer question or question is not applicable | *when interfaced with GEM OPL CO-Oximeter |
Tabulation does not represent an endorsement by the College of American Pathologists. |