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Instrumentation Laboratory, GEM Premier 4000 (In vitro blood gas 2012)

Instrumentation Laboratory, GEM Premier 4000 (In vitro blood gas 2012)

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Contact Information

Instrumentation Laboratory
Customer Service
customerservice@ilww.com
180 Hartwell Road
Bedford, MA 01730
800-955-9525


Name of device/First year sold/Number of analyzers sold in 2011 GEM Premier 4000/2006/—
Number of devices sold in U.S./outside U.S./List price >4,300 worldwide/$50,000
Dimensions (H x W x D)/Weight 18 × 12 × 15 inches/44 pounds
Analytes measured on device pH, pCO2, pO2, Hct, Na, K, Cl, iCa, lactate, glucose, tHb, O2Hb, COHb, MetHb, HHb, tBili
Parameters calculated on device Hct, TCO2, BEecf (in vivo), BE(B) (in vivo), tHb(c), Ca++ (7.4), anion gap, P/F ratio, pAO2,CaO2, CvO2, P50, O2cap, sO2, sO2(c), HCO3-std, HCO3-(c), others
Barometric pressure —
Analytical method(s) or technologies employed pH, pCO2: potentiometry; pO2, glucose, lactate: amperometry; Hct: conductivity; Hb, 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 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 multi-use cartridge
No. of disposable reagent system units in standard package 1
No. of samples analyzed per one disposable reagent, electrode system cartidges available: 75, 150, 300, 450, 600
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 multi-use cartridge
Shelf life of components 6 months (cartridge)
Cost per test/Reagent cost per test varies with cartridge 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 yes
System can use LOINC to transmit results to LIS no
Specimen types suitable for device whole blood, capillary, mixed venous, arterial, venous
Acceptable anticoagulants/Sampling technique heparin/aspiration
Sample size for complete panel of analyte results 150 µL, 95 µL (electrochemical only), 65 µL micro mode (electrochemical only)
Sample size differs with number of analytes selected yes
Time from sample introduction to result availability 70 seconds for electrochemical; 25 additional seconds for CO-ox
Maximum No. of patient samples per hour/Maximum No. measured results per hour 20/300
Optimal throughput when analyzer calibrated, awaiting specimens 20 samples per hour
Calibration can be interrupted to perform stat sample yes
Known interferences interfering substance detected, operator notified
Sampler has self-wiping probe yes
Time required for maintenance by lab personnel none
Service center performs diagnostics through modem no (but can through VPN)
Method of analyst ID in system wireless bar-code gun or manual virtual keyboard entry
Instrument response for:
• hardware failure/software failure operator warning, sampling lockout
• QC failure iQM disables analyte channel; no result reported
• calibration failure system automatically performs checks before samples can be analyzed
For what bar-code scanning is provided operator and patient IDs, cartridge lot number and expiration date
Built-in printer/Data port yes/4 RS-232, 1 parallel port, 1 Ethernet port, 4 USB ports
Information listed on hard copy report patient demographics, hospital information, results, result flags and legend, reference and critical ranges (optional), comments, notification information
Analyzer connections LIS/HIS via direct interface or GEMweb Plus Custom Connectivity; vendor-neutral or Web-based systems
Interface standards supported ASTM 1394, 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, results, QC ID
Hardware and software for data management system GEMweb Plus
No. of different management reports system produces 4
Contents downloaded from data management system to analyzer most configuration information, including valid operator IDs, QC 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 (provided by company) iQM detects, corrects, documents instrument errors, reducing error detection time to minutes; single component, multi-use cartridge includes all testing components, is changed every 30 days, requires no refrigeration or maintenance; GEMweb Plus software allows access and control from any networked PC or GEM Premier 4000 analyzer; Plus Technology offers faster touchscreen response, wireless communication to HIS/LIS, and remote service capabilities
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.