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Instrumentation Laboratory, GEM Premier 5000

Instrumentation Laboratory, GEM Premier 5000

In vitro blood gas analyzers, May 2017

Contact Information

Instrumentation Laboratory
Customer Service
180 Hartwell Rd.
Bedford, MA 01730

Name of device/First year sold/Number of analyzers sold in 2016 GEM Premier 5000/2015/—
Number of devices sold in U.S./Outside U.S./List price >200 worldwide/$57,500
Dimensions (H x W x D)/Weight 18.6 × 13.0 × 16.4 inches/45.4 pounds
Analytes measured on device pH, pO2, pCO2, Hct, Na, K, Cl, iCa, glucose, lactate, tHb, O2Hb, HHb, COHb, MetHb, sO2, tBili
Parameters calculated on device TCO2, BEecf (in vivo), BE(B) (in vivo), tHb(c), Ca++ (7.4), anion gap, P/F ratio, pAO2, CaO2, CvO2, P50, O2ct, O2cap, sO2(c), HCO3-std, HCO3-(c), A-aDO2, paO2/pAO2, RI, CcO2, a-VDO2, Qsp/Qt(est), Qsp/Qt, Hct(c), temperature corrections
Barometric pressure
Analytical method(s) or technologies employed pH, pCO2: potentiometry; pO2, glucose, lactate: amperometry; Hct: conductivity; Hb, O2Hb, COHb, MetHb, HHb, tBili: spectrophotometric; Na, Cl, iCa, K: potentiometric ion-selective electrode
Device is part of a series of related models yes
Device warranty/Loaner devices provided yes/5 years
Average life expectancy of device 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 clinical laboratory
Point of care:
Disposable prepackaged system used for analysis all-in-one, multiuse cartridge
No. of disposable reagent system units in standard package 1
No. of samples analyzed per one disposable reagent, electrode system 75-, 150-, 300-, 450-, and 600-test cartridge
Reagent unit storage requirements room temperature
Shelf life of disposable units 6 months
No. of different disposable reagents required to maintain device 1
Max. No. of analyte reagents that can reside in device at once 1 all-in-one, 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 2 (iQM2)
Calibration frequency automated continuous with iQM2
Internal QC program recommended internal, automated, continuous quality management included
QC features/Capabilities of QC features onboard iQM2/automated on-demand monthly reports include number of measurements, mean, maximum, and minimum delta values
Remote control of device from laboratory yes (with GEMweb Plus)
System can use LOINC to transmit results to LIS yes
Specimen types suitable for device heparanized whole blood (arterial, venous, mixed venous, capillary*)
Acceptable anticoagulants/Sampling technique heparin/aspiration
Sample size for complete panel of analyte results 150 µL, 100 µL (CO-Ox and tBili), 65 µL micro mode*
Sample size differs with number of analytes selected no
Time from sample introduction to result availability 45 seconds
Max. No. of patient samples per hour/Max. No. measured results per hour 29/493
Optimal throughput when analyzer calibrated, awaiting specimens 29 samples per hour
Calibration can be interrupted to perform stat sample yes
Known interferences interferences detected by iQM2 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 (VPN data transfer can be configured)
Method of analyst ID in system barcode reader or manual virtual keyboard entry
Instrument response for:
• hardware failure/software failure operator warning, sampling lockout if necessary/operator warning, sampling lockout if necessary
• QC failure iQM2 will automatically detect and perform corrective actions or disable analyte if necessary
• calibration failure iQM2 will automatically detect and perform corrective actions or disable analyte if necessary
For what barcode scanning is provided operator and patient IDs, GSE/GHE lot number
Built-in printer/Data port yes/4 RS-232 serial ports, 1 parallel port, 1 Ethernet port, 4 USB ports
Information listed on hard copy report patient demographics, hospital name and address, results, result flags and legend, reference and critical ranges (optional), comments, notification information
Analyzer connections LIS/HIS via GEMweb Plus Custom Connectivity, vendor-neutral or Web-based systems
Interface standards supported ASTM 1397, HL7
How analyzer connects to external system to upload patient and QC results direct serial, hospital network, real-time wireless
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 GEMweb Plus
No. of different management reports system produces 4 (15 additional reports with GEMweb Plus)
Contents downloaded from data-management system to analyzer most configuration information, including valid operator IDs, lots, and ranges
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) iQM2 with IntraSpect technology detects potential errors, to include transient errors before, during, and after each sample analysis, along with real-time correction and documentation; iQM2 performs five process control solutions continuously to monitor sensor performance at all pertinent medical decision levels throughout cartridge-life use; enhanced operational and workflow efficiency through 31-day all-in-one, multiuse PAK that requires no refrigeration or maintenance; software allows complete control of analyzers, operators, or data through a networked PC, mobile device, or analyzer
Note: a dash in lieu of an answer means company did not answer question or question is not applicable *not available in all countries
Tabulation does not represent an endorsement by the College of American Pathologists.