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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. |
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