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Instrumentation Laboratory, GEM Premier 3500

Instrumentation Laboratory, GEM Premier 3500

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 3500/2009/—
Number of devices sold in U.S./Outside U.S./List price >3,000 worldwide/$45,000
Dimensions (H x W x D)/Weight 17.5 × 13 × 11.8 inches/31.2 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 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 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/monthly report includes 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
Instrument response for:
• hardware failure/software failure operator warning, sampling lockout if necessary/operator warning, sampling lockout if necessary
• 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/4 USB, 3 RS-232, 1 parallel, barcode reader port, Ethernet
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 and HL7 protocols
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 GEMweb, GEMweb Plus, 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, and sample errors, reducing error-detection time to minutes; maintenance-free, single, multiuse cartridge available in customizable configurations for use in any hospital location; wireless communication to LIS or HIS
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.