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ITC, IRMA TRUpoint Blood Analysis System (In vitro blood gas 2014)

ITC, IRMA TRUpoint Blood Analysis System (In vitro blood gas 2014)

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Contact Information

ITC
8 Olsen Ave.
Edison, NJ 08820
800-631-5945


Name of device/First year sold/Number of analyzers sold in 2012 IRMA TRUpoint Blood Analysis System/1994/—
Number of devices sold in U.S./outside U.S./List price >6,000 worldwide/—
Dimensions (H x W x D)/Weight 11.5 × 9.5 × 5 inches/5 pounds, 4 ounces
Analytes measured on device pH, pCO2, pO2, Hct, Na, K, Cl, iCa, glucose, BUN, creatinine, lactate
Parameters calculated on device Hb, O2SAT, BEb, BEecf, TCO2, HCO3-, iCa(n), creatinine MDRD-GFR
Barometric pressure measured
Analytical method(s) or technologies employed pH, pCO2, Na, Cl, iCa, K, BUN, creatinine, lactate (enzymatic): potentiometric; pO2, glucose (enzymatic): amperometric; Hct: conductometric
Device is part of a series of related models yes
Device warranty/Loaner devices provided 1 year/yes
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
Point of care:
Disposable prepackaged system used for analysis reagent/electrode (single use)
No. of disposable reagent system units in standard package 25
No. of samples analyzed per one disposable reagent, electrode system 1
Reagent unit storage requirements room temperature; creatinine 2°–8°C
Shelf life of disposable units up to 6 months
Laboratory:
No. of different disposable reagents required to maintain device
Max. No. of analyte reagents that can reside in device at once
Shelf life of components
Cost per test/Reagent cost per test
Calibrations required 2 point (automatic)
Calibration frequency automatic with each sample
Internal QC program recommended automatic electronic QC per 8 hours
QC features/Capabilities of QC features L-J plots/statistical calculations, monthly cumulative reports (IDMS)
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, EDTA (glucose strip only)/injection
Sample size for complete panel of analyte results 125 µL capillary, 200 µL syringe
Sample size differs with number of analytes selected no
Time from sample introduction to result availability 60–90 seconds on average
Maximum No. of patient samples per hour/Maximum No. measured results per hour 25/175
Optimal throughput when analyzer calibrated, awaiting specimens 20 samples per hour
Calibration can be interrupted to perform stat sample
Known interferences
Sampler has self-wiping probe no, not needed
Time required for maintenance by lab personnel none
Service center performs diagnostics through modem no
Method of analyst ID in system LCD touchscreen, numeric (customizable)
Instrument response for:
• hardware failure/software failure EQC failure or screen prompt/screen prompt
• QC failure if QC required, no access to patient testing mode
• calibration failure test ends (no injection of sample allowed)
For what bar-code scanning is provided operator and patient IDs, cartridge information, lot number, quality control ranges
Built-in printer/Data port yes/RS-232, modem, Ethernet, LAN
Information listed on hard copy report analyzer serial number, date, calibration successful, calibration code, lot number, patient ID and temperature, results, barometric pressure, SW version optional: user ID, reference ranges, O2 therapy, sample information
Analyzer connections data management systems connect to LIS/HIS; directly to LIS/HIS (both options)
Interface standards supported IRMA
How analyzer connects to external system to upload patient and QC results hospital network, direct serial, LAN
Information included in transmission from analyzer to external system device-unique identifier, operator and patient IDs, results, QC identifier, patient O2 therapy information
Hardware and software for data management system connects to Alere (MAS RALS+ and LDS Aegis POC) and Telcor data management systems
No. of different management reports system produces 19
Contents downloaded from data management system to analyzer all analyzer settings, software upgrades
System connected (live installations) to which LISs, HISs major HIS/LIS vendors
Use a third-party interfacing tool, engine for LIS, HIS interfaces yes
Distinguishing features (provided by company) self-contained and easy to use; contains onboard printer, interactive touchscreen, bar-code scanning, automatic electronic QC, and site-specific custom correlation reference ranges; complete data management from patient information to lot traceability; self-calibrating cartridges with Luer lockport, which forms a closed system and reduces biohazards
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.