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| Name of device/First year sold/Number of analyzers sold in 2011 | 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; software: 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 (ASTM protocol), ITC Ensemble (script, HL7, or EDI) |
| 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. |