24 / CAP TODAY

August 2011

In vitro blood gas analyzers

Part 1 of 8 Abbott Point of Care Kevin Ball kevin.ball@apoc.abbott.com 400 College Road East Princeton, NJ 08540 800-827-7828 www.abbottpointofcare.com i-STAT System/1992/ 30,000+/20,000+/$8,761 9.25 3.0 2.85 inches/22.4 ounces pH, pCO2, pO2, Hct, Na, K, Cl, iCa, lactate, glucose, creatinine, BUN, TCO2, cTnl, CK-MB, BNP, ACT, PT/INR Hb, HcT, O2SAT, BE, TCO2, HCO3 Alere, Inc. Mark Steinberg mark.steinberg@alere.com 30 South Keller Rd., Suite 100 Orlando, FL 32810 888-893-6225 www.alere.com epoc Blood Analysis System/2008/ //$7,500 3 3.4 8.5 inches/~1.5 pounds pH, pCO2, p02, Hct, Na, K, iCa, lactate, glucose Hb, 02SAT, BE, TCO2, HCO3 Instrumentation Laboratory Mike Wright mwright@ilww.com 180 Hartwell Road Bedford, MA 01730 781-861-4165 www.ilus.com GEM Premier 3000/2000/1,450 >2,000/>8,000/$39,995 17 12 12 inches/29.5 pounds pH, pO2, pCO2, Hct, Na+, K+, Ca++, glucose, lactate A-aDo2, Hb, pAO2, paO2/pAO2, RI, O2cap*, O2Ct*, CtO2*, CaO2*, CvO2*, CcO2*, a-vDO2*, Qsp/Qt, P50, HCO3-, BEb, BEcecf, S02c pH, pCO2: potentiometry; pO2, glucose, lactate: Na, iCa, K: amperometry; Hct: conductivity; potentiometric ion selective electrode yes 5 years/yes 710 years closed/no point-of-care testing and laboratory multi-use cartridge 1 per pack 35-, 75-, 150-, 300-, 450-, and 600-test cartridge room temperature 6 months 1 1 multi-use cartridge 6 months varies with size and menu automated continuous with iQM automated continuous with iQM internal, automated, continuous quality mgmt. included onboard Intelligent Quality Management/monthly report includes number of measurements, mean, maximum, and minimum delta values yes no whole blood, arterial, venous, or capillary heparin/aspiration 135 to 150 L no 85 seconds 20/180 20 samples per hour yes yes none (disposable cartridge) no (but can through VPN) manual or bar-code entry of ID and password (customizable) operator warning, sampling lockout channel flagged no results for channel operator and patient IDs, QC values yes/3 RS-232, 1 parallel, bar-code reader port, Ethernet port patient demographics, hospital name and address, results GEMweb, GEMweb Plus, Impact for Critical Care ASTM protocol direct serial, Ethernet, modem dial-in device identifier, operator and patient IDs, results, QC ID and results Impact for Critical Care customizable patient ID, demographics major HIS/LIS vendors MAS/RALS, Telcor iQM detects, corrects, and documents instrument errors, reducing error detection time to minutes; maintenance-free, multi-use cartridge available in customized configurations for use in any hospital location; wireless communication to LIS or HIS

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device

Barometric pressure Analytical method(s) or technologies employed

measured electrochemical for all analytes

recorded pH, iCa, pC02, Na, K: potentiometry; p02, lactate, glucose: amperometry; Hct: conductometric; Hb: calculated no initial 1-year warranty; extended warranty available closed/no point-of-care testing reagent/electrode (single use) 50 1 room temperature up to 6 months 1 point (automatic) every test

Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features

no 1-year replacement/yes 8 years closed/no point-of-care testing reagent/electrode (single use) 25 per box 1 refrigerate, two-month shelf life for blood gas cartridges, two- week shelf life for all others 69 months 1 point (automatic) every test electronic QC, automated internal wet QC comparable plot/monthly cumulative reports (available with external system) yes no whole blood, capillary, mixed venous, arterial, venous heparin/injection, capillary transfer, and fill blood gas 96 L, electrolytes 65 L no about 2 minutes 20 per unit/160 yes keypad entry/bar-code scanner (customizable) code number error message code number error message code number error message operator and patient IDs, reagent lot number no/ device-unique identifier, operator and patient IDs, results, QC results, QC identifier LIS/HIS, via data management system ASTM 1394 and 1238, HL7 hospital network device-unique identifier, operator and patient IDs, results, QC identifier, others PrecisionWeb, Central Data Station 35+ valid operator IDs, device behavior customizations major LIS vendors yes, Sybase Interface Manager handheld, portable, single-use test cartridge menu; broad test menu on a single point-of-care platform; laboratory-accurate results at the bedside

Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Maximum No. of patient samples per hour/Maximum No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report Analyzer connections Interface standards supported How analyzer connects to external system to upload patient and QC results Information included in transmission from analyzer to external system Hardware and software for data management system No. of different management reports system produces Contents downloaded from data management system to analyzer System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces Distinguishing features (provided by company)

yes yes whole blood, capillary, mixed venous, arterial, venous heparin/injection, capillary transfer and fill ~92 mL no ~35 seconds no no no error code, rejection of card failure noted on final report card rejected operator and patient IDs, reagent lot number, all open fields no/ all LIS/HIS, via data management system HL7 real-time wireless (RF) device-unique identifier, operator and patient IDs, results, QC identifier, others software only customizable valid operator IDs, others most yes, Mirth room-temperature card storage (up to 6 months); bar-coded test cards for quality and inventory management; fully wireless data transfer to data manager, real time (no need to dock for download)

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.

Survey editor: Raymond Aller, MD

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August 2011

In vitro blood gas analyzers

Part 2 of 8 Instrumentation Laboratory Mike Wright mwright@ilww.com 180 Hartwell Road, Bedford, MA 01730 781-861-4165 www.ilus.com GEM Premier 3500/2009/ 778 worldwide/$45,000 17.5 13 11.8 inches/31.2 pounds pH, pO2, pCO2, Hct, Na+, K+, Ca++, glucose, lactate A-aDo2, Hb, pAO2, paO2/pAO2, RI, O2cap*, O2Ct*, CtO2*, CaO2*, CvO2*, CcO2*, a-Qsp/Qt, P50, HCO3-, tCO2-, BEB, BEcecf, SO2c pH, pCO2: potentiometry; pO2, glucose, lactate, Na, iCa, K: amperometry; Hct: conductivity; potentiometric ion-selective electrode yes 5 years/yes 710 years closed/no point-of-care testing and laboratory multi-use cartridge 1 per pack 75-, 150-, 300-, 450-, and 600-test cartridge room temperature 6 months 1 1 multi-use cartridge 6 months varies with size and menu automated continuous with iQM automated continuous with iQM internal, automated, continuous quality management included onboard Intelligent Quality Management/monthly report includes number of measurements, mean, maximum, and minimum delta values yes no whole blood, arterial, venous, or capillary heparin/aspiration 135150 L no 85 seconds 20/180 20 samples per hour yes yes none (disposable cartridge) no (but can through VPN) manual or bar-code entry of ID and password (customizable) operator warning, sampling lockout channel flagged no results for channel operator and patient IDs, QC values yes/4 USB, 3 RS-232, 1 parallel, bar-code reader port, Ethernet patient demographics, hospital name and address, results Instrumentation Laboratory Bill Manchester billm@ilww.com 180 Hartwell Road, Bedford, MA 01730 781-861-4360 www.ilus.com GEM Premier 4000/2006/ >4,100 worldwide/$50,000 18 12 15 inches/44 pounds pH, pCO2, pO2, Hct, Na, K, Cl, iCa, lactate, glucose, tHb, O2Hb, COHb, MetHb, HHb, tBili 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 pH, pCO2: potentiometry; pO2, glucose, lactate: amperometry; Hct: conductivity; Hb, tBili: spectrophotometric; Na, Cl, iCa, K: potentiometric ion-selective electrode yes 5 years/yes 710 years closed/no point-of-care testing and laboratory multi-use cartridge 1 per pack cartidges available: 75, 150, 300, 450, 600 room temperature 6 months 1 1 multi-use cartridge 6 months (cartridge) varies with cartridge size and menu/ automated continuous with iQM automated continuous with iQM internal, automated, continuous quality management included onboard Intelligent Quality Management/monthly report includes number of measurements, mean, maximum, and minimum delta values yes no whole blood, capillary, mixed venous, arterial, venous heparin/aspiration 150 L, 95 L (electrochemical only), 65 L micro mode (electrochemical only) yes 70 seconds for electrochemical; 25 additional seconds for CO-ox 20/300 20 samples per hour yes interfering substance detected, operator notified yes none no (but can through VPN) wireless bar-code gun or manual virtual keyboard entry operator warning, sampling lockout iQM disables analyte channel; no result reported system automatically performs checks before samples can be analyzed operator and patient IDs, cartridge lot number and expiration date yes/4 RS-232, 1 parallel port, 1 Ethernet port, 4 USB ports patient demographics, hospital info, results, result flags and legend, reference and critical ranges (optional), comments, notification info LIS/HIS via direct interface or GEMweb Plus Custom Connectivity; vendor-neutral or Web-based systems ASTM 1394, HL7 direct serial, hospital network, real-time wireless device identifier, operator and patient IDs, results, QC ID GEMweb Plus 4 most configuration information, including valid operator IDs, QC lots, and ranges major HIS/LIS vendors MAS/RALS, Telcor iQM detects, corrects, documents instrument errors, reducing error detection time to minutes; single component, multi-use GEM Premier 4000 cartridge includes all testing components, is changed every 30 days, requires no refrigeration or maintenance; GEMweb Plus Custom Connectivity software allows access and control from any networked PC or GEM Premier 4000 analyzer ITC Nexus Dx 8 Olsen Ave. Edison, NJ 08820 800-631-5945 www.itcmed.com IRMA TRUpoint Blood Analysis System/1994/ 6,000 worldwide/ 11.5 9.5 5 inches/5 pounds, 4 ounces pH, pCO2, pO2, Hct, Na, K, Cl, iCa, glucose, BUN, creatinine, lactate Hb, O2SAT, BEb, BEecf, TCO2, HCO3-, iCa(n), creatinine MDRD-GFR measured pH, pCO2, Na, Cl, iCa, K, BUN, creatinine, lactate (enzymatic): potentiometric; pO2, glucose (enzymatic): amperometric; Hct: conductometric yes 1 year/yes 7 years closed/no point-of-care testing reagent/electrode (single use) 25 per box 1 room temperature; creatinine 28C up to 6 months 2 point (automatic) automatic with each sample automatic electronic QC per 8 hours L-J plots/statistical calculations, monthly cumulative reports (IDMS) yes no whole blood, capillary, mixed venous, arterial, venous heparin, EDTA (glucose strip only)/injection 125 L capillary, 200 L syringe no 6090 seconds on average 25/175 20 samples per hour no, not needed none no LCD touchscreen, numeric (customizable) EQC failure or screen prompt; software: screen prompt if QC required, no access to patient testing mode test endsno injection of sample allowed operator and patient IDs, cartridge information, lot number, quality control ranges yes/RS-232, modem, Ethernet, LAN 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 data management system, which connects to LIS/ HIS; directly to LIS/HIS (both options) IRMA (ASTM protocol), IDMS (script, HL7, or EDI) hospital network, direct serial, LAN device unique identifier, operator and patient IDs, results, QC identifier, patient O2 therapy information integrated data management system, also integrates ITC CO-oximetry and coagulation devices, connects to MAS, Telcor, and Aegis POC data managers 24 all analyzer settings, software upgrades major HIS/LIS vendors yes 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

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device

Barometric pressure Analytical method(s) or technologies employed

Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Maximum No. of patient samples per hour/Maximum No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report

Analyzer connections Interface standards supported How analyzer connects to external system to upload patient and QC results Information included in transmission from analyzer to external system Hardware and software for data management system No. of different management reports system produces Contents downloaded from data management system to analyzer System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces Distinguishing features (provided by company)

GEMweb, GEMweb Plus, Impact for Critical Care ASTM and HL7 protocols direct serial, Ethernet, modem dial-in device identifier, operator and patient IDs, results, QC ID and results GEMweb, GEMweb Plus, Impact for Critical Care customizable patient ID, demographics major HIS/LIS vendors MAS/RALS, Telcor iQM detects, corrects, and documents instrument errors, reducing error detection time to minutes; maintenance-free, multi-use 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

Tabulation does not represent an endorsement by the College of American Pathologists.

28 / CAP TODAY

August 2011

In vitro blood gas analyzers

Part 3 of 8 Nova Biomedical Sales info@novabiomedical.com 200 Prospect St. Waltham, MA 02454-9141 800-458-5813 Stat Profile pHOx Basic/2002/ 15 12 15 inches/18 pounds pH, pCO2, pO2 BE, TCO2, HCO3tracked pH: direct ISE; PCO2: Severinghaus; PO2: amperometry yes 1 year, repair or replace any part, including labor/yes 57 years closed/no point-of-care testing and laboratory reagent 200 to 500 analyses room temperature reagents: 18 months at room temperature; electrodes: up to 18 months 1 1 reagents and electrodes: 18 months; membrane kits: 12 to 24 months <$0.11 at 35 analyses per day/<$0.08 at 35 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 4, or 6 hours (user defined) minimum CLIA recommendations L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager) no no whole blood, capillary, mixed venous, arterial heparin/aspiration and capillary 70 L yes, standard three-test blood gas micro-panel sample required is 45 L 45 seconds 300/300 tests 300 tests per hour yes yes weekly: <5 minutes; monthly: <10 minutes yes password with unique user ID number (optional) self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure patient ID yes/multiple RS-232 patient ID with accession number, entered settings, measures and calculates results Nova Biomedical Sales info@novabiomedical.com 200 Prospect St. Waltham, MA 02454-9141 800-458-5813 Stat Profile pHOx/1998/ 15 12 15 inches/18 pounds pH, PCO2, PO2, Hct, Hb, SO2% BE, TCO2, HCO3tracked pH: direct ISE; PCO2: Severinghaus; PO2: amperometry; Hct: conductivity; Hb and SO2%: opticalreflectance yes 1 year, travel and labor, repair, or replacement/yes 57 years closed/no point-of-care testing and laboratory reagent 200 to 500 analyses room temperature reagents: 18 months at room temperature; electrodes: up to 18 months 1 1 reagents and electrodes: 18 months; membrane kits: 12 to 24 months <$0.11 at 35 analyses per day/<$0.08 at 35 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 4, or 6 hours (user defined) minimum CLIA recommendations L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager) no no whole blood, capillary, mixed venous, arterial heparin/aspiration and capillary 70 L yes, standard 3-test blood gas micro-panel sample required is 45 L 45 seconds 300/300 tests 300 tests per hour yes yes weekly: <5 minutes; monthly: <10 minutes yes password with unique user ID number (optional) self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure patient ID yes/multiple RS-232 patient ID with accession number, entered settings, measures and calculates results Nova Biomedical Sales info@novabiomedical.com 200 Prospect St. Waltham, MA 02454-9141 800-458-5813 Stat Profile pHOx Respiratory/2006/ 15 12 15 inches/18 pounds pH, PCO2, PO2, Hct, Hb, SO2%, lactate BE, TCO2, HCO3tracked pH: direct ISE; PCO2: Severinghaus; PO2: amperometry; Hct: conductivity; Hb and SO2%: opticalreflectance; lactate: enzyme/amperometric yes 1 year, travel and labor, repair, or replacement/yes 57 years closed/no point-of-care testing and laboratory reagent 200 to 500 analyses room temperature reagents: 18 months at room temperature; electrodes: up to 18 months 1 1 reagents and electrodes: 18 months; membrane kits: 12 to 24 months <$0.11 at 35 analyses per day/<$0.08 at 35 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 4, or 6 hours (user defined) minimum CLIA recommendations L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager) no no whole blood, capillary, mixed venous, arterial heparin/aspiration and capillary 125 L yes, standard 3-test micro-panel required is 60 L 52 seconds 50/500 tests 300 tests per hour yes yes weekly: <5 minutes; monthly: <10 minutes yes password with unique user ID number (optional) self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure patient ID yes/multiple RS-232 patient ID with accession number, entered settings, measures and calculates results

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device Barometric pressure Analytical method(s) or technologies employed Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Max. No. of patient samples per hour/Max. No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report

Analyzer connections Interface standards supported How analyzer connects to external system to upload patient and QC results Information included in transmission from analyzer to external system Hardware and software for data management system No. of different management reports system produces Contents downloaded from data management system to analyzer System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces Distinguishing features (provided by company)

data-management system that connects to LIS/HIS ASTM E1381-91 and ASTM 1394-91 (HL7 available with external device) direct serial/>500 hospitals institutions; hospital network/>100 institutions device-unique identifier, operator and patient IDs, results, QC identifier, accession number Pentium with Microsoft NT 4.0/Nova Point-of-Care Manager SW >60 yes onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection

data-management system or directly to LIS/HIS, or both data-management system or directly to LIS/HIS, or both ASTM E1381-91 and ASTM 1394-91 (HL7 available with external device) direct serial/>500 hospitals institutions; hospital network/>100 institutions device-unique identifier, operator and patient IDs, results, QC identifier, accession number Pentium with Microsoft Windows 2000/Nova Point-of-Care Manager >60 yes, patient name, passwords yes onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection ASTM E1381-91 and ASTM 1394-91 (HL7 available with external device) direct serial/>500 hospitals institutions; hospital network/>100 institutions device-unique identifier, operator and patient IDs, results, QC identifier, accession number Pentium with Microsoft Windows 2000/Nova Point-of-Care Manager >60 yes, patient name, passwords yes onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection

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.

30 / CAP TODAY

August 2011

In vitro blood gas analyzers

Part 4 of 8 Nova Biomedical Sales info@novabiomedical.com 200 Prospect St. Waltham, MA 02454-9141 800-458-5813 Stat Profile pHOx Plus/2000/ 15 12 15 inches/18 pounds pH, PCO2, PO2, Hct, Hb, SO2%, Na, K, Cl or iCa, glucose BE, TCO2, HCO3tracked pH: direct ISE; PCO2: Severinghaus; PO2: amperometry; Hct: conductivity; Hb and SO2%: opticalreflectance; Na, K, Cl, iCa: direct ISE; glucose: enzyme/amperometric yes 1 year, travel and labor, repair or replacement/yes 57 years closed/no point-of-care testing and laboratory reagent 200 to 500 analyses room temperature reagents: 18 months at room temperature; electrodes: up to 18 months 1 1 reagents and electrodes: 18 months; membrane kits: 12 to 24 months <$0.11 at 35 analyses per day/<$0.08 at 35 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 4, or 6 hours (user defined) minimum CLIA recommendations L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager) no no whole blood, capillary, mixed venous, arterial heparin/aspiration and capillary 115 L yes, micro-panel; standard 3-test micro-panel required is 55 L 50 seconds 50/500 tests 300 tests per hour yes yes weekly: <5 minutes; monthly: <10 minutes yes password with unique user ID number (optional) self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure patient ID yes/multiple RS-232 patient ID with accession number entered settings, measures and calculates results data-management system or directly to LIS/HIS, or both Nova Biomedical Sales info@novabiomedical.com 200 Prospect St. Waltham, MA 02454-9141 800-458-5813 Stat Profile pHOx Plus L/2001/ 15 12 15 inches/18 pounds pH, PCO2, PO2, Hct, Hb, SO2%, Na, K, Cl or iCa, glucose, lactate BE, TCO2, HCO3tracked pH: direct ISE; PCO2: Severinghaus; PO2: amperometry; Hct: conductivity; Hb and SO2%: opticalreflectance; Na, K, Cl, iCa: direct ISE; glucose, lactate: enzyme/amperometric yes 1 year, travel and labor, repair or replacement 57 years closed/no point-of-care testing and laboratory reagent 200 to 500 analyses room temperature reagents: 18 months at room temperature; electrodes: up to 18 months 1 1 reagents and electrodes: 18 months; membrane kits: 12 to 24 months <$0.11 at 35 analyses per day/<$0.08 at 35 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 4, or 6 hours (user defined) minimum CLIA recommendations L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager) no no whole blood, capillary, mixed venous, arterial, serum plasma heparin/aspiration and capillary 125 L yes, standard 3-test micro-panel required is 60 L 52 seconds 50/500 tests 300 tests per hour yes none yes weekly: <5 minutes; monthly: <10 minutes yes password with unique user ID number (optional) self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure patient ID yes/multiple RS-232 patient ID with accession number entered settings, measures and calculates results data-management system or directly to LIS/HIS, or both ASTM E1381-91 and ASTM 1394-91 (HL7 available with external device) direct serial/>500 hospitals institutions; hospital network/>100 institutions device unique identifier, operator and patient IDs, results, QC identifier, accession number Pentium with Microsoft Windows 2000/Nova Point-of-Care Manager >60 yes, patient name, passwords yes onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection Nova Biomedical Sales info@novabiomedical.com 200 Prospect St. Waltham, MA 02454-9141 800-458-5813 Stat Profile pHOx Plus C/2003/ 15 12 15 inches/18 pounds pH, PCO2, PO2, Hct, Hb, SO2%, Na, K, Cl, iCa, glucose BE, TCO2, HCO3tracked pH: direct ISE; PCO2: Severinghaus; PO2: amperometry; Hct: conductivity; Hb and SO2%: opticalreflectance; Na, K, Cl, iCa: direct ISE; glucose: enzyme/amperometric yes 1 year, travel and labor, repair or replacement 57 years closed/no point-of-care testing and laboratory reagent 200 to 500 analyses room temperature reagents: 18 months at room temperature; electrodes: up to 18 months 1 1 reagents and electrodes: 18 months; membrane kits: 12 to 24 months <$0.11 at 35 analyses per day/<$0.08 at 35 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 4, or 6 hours (user defined) minimum CLIA recommendations L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager) no no whole blood, capillary, mixed venous, arterial, serum plasma heparin/aspiration and capillary 125 L yes, standard 3-test micro-panel required is 60 L 52 seconds 50/500 tests 300 tests per hour yes none yes weekly: <5 minutes; monthly: <10 minutes yes password with unique user ID number (optional) self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure patient ID yes/multiple RS-232 patient ID with accession number entered settings, measures and calculates results data-management system or directly to LIS/HIS, or both ASTM E1381-91 and ASTM 1394-91 (HL7 available with external device) direct serial/>500 hospitals institutions; hospital network/>100 institutions device unique identifier, operator and patient IDs, results, QC identifier, accession number Pentium with Microsoft Windows 2000/Nova Point-of-Care Manager >60 yes, patient name, passwords yes onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device Barometric pressure Analytical method(s) or technologies employed

Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Maximum No. of patient samples per hour/Maximum No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report Analyzer connections Interface standards supported

ASTM E1381-91 and ASTM 1394-91 (HL7 available with external device) How analyzer connects to external system to upload patient and QC results direct serial/>500 hospitals institutions; hospital network/>100 institutions Information included in transmission from analyzer to external system device unique identifier, operator and patient IDs, results, QC identifier, accession number Hardware and software for data management system Pentium with Microsoft Windows 2000/Nova Point-of-Care Manager No. of different management reports system produces >60 Contents downloaded from data management system to analyzer yes, patient name, passwords System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces yes Distinguishing features (provided by company) onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection

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.

August 2011

CAP TODAY / 31

In vitro blood gas analyzers

Part 5 of 8 Nova Biomedical Sales info@novabiomedical.com 200 Prospect St., Waltham, MA 02454-9141 800-458-5813 Stat Profile Critical Care Xpress/2003/ 17.2 22.4 17.3 inches/53 pounds pH, pCO2, pO2, Hct, Hb, Na, K, Cl, iCa, iMg, lactate, glucose, creatinine, BUN, SO2%, bilirubin, CO-oximetry BE, TCO2, HCO3tracked pH: direct ISE; pCO2: Severinghaus; pO2: amperometric; Hct: conductivity; Hb and SO2%: optical-reflectance; Na, K, Cl, iMg, and iCa: direct ISE; lactate, glucose, and creatinine: enzyme/amperometric; BUN: enzyme/ISE; bilirubin, CO-ox: optical, reflectance yes 1 year 57 years closed/no point-of-care testing and laboratory reagent 200500 analyses no special requirements reagents: 18 months (at room temperature); electrodes: up to 18 months 1 20 reagents and electrodes: 18 months; membrane kits: 1224 months <$0.08 at 40 analyses per day/$0.04 at 40 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 3, 4, 5, or 6 hours (user defined) minimum CLIA recommendations L-J plots/statistical calculations, monthly cumulative report (onboard, more extensive reporting available with Nova Point-of-Care Manager) no yes whole blood, capillary, mixed venous, arterial, venous heparin/aspiration and capillary 210 L yes, variety of micro-panel options offered and can be customized 134 seconds 22/440 437 tests per hour yes none yes weekly: <5 minutes; monthly: <10 minutes yes multilevel password with unique user ID number self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure operator and patient IDs yes/Ethernet, USB patient ID and accession numbers, entered settings, measured and calculated results directly to LIS/HIS, DMS that in turn connects to LIS/HIS ASTM E1394-91, ASTM 1381-91, HL7 modem dial-in, hospital network device unique identifier, operator and patient IDs, results, QC identifier full-featured onboard DMS capability, external DMS also available >30 valid control Nos., valid operator IDs, patient demographics most analyzers interfaced to LIS using LIS vendors drivers large whole blood critical care menu (20 tests), BUN, iMg available exclusively from Nova; onboard CO-oximeter Nova Biomedical Sales info@novabiomedical.com 200 Prospect St., Waltham, MA 02454-9141 800-458-5813 Stat Profile Critical Care Xpress 3 Plus/2003/ 17.2 22.4 17.3 inches/53 pounds pH, pCO2, pO2, CO-oximetry BE, TCO2, HCO3tracked pH: direct ISE; pCO2: Severinghaus; pO2: amperometric; CO-ox: optical-reflectance Opti Medical Systems Inc. Sales Department 235 Hembree Park Drive, Roswell, GA 30076 800-490-6784 www.optimedical.com OPTI R/2006/ 4.7 14.2 14 inches/4.5 kg (10 pounds) without fluid pack pH, pCO2, pO2, tHb, Na, K, iCa, SO2 Hct, HCO3, BE, BEecf, BEact, BB, tCO2, st. HCO3, st. pH, O2ct, cH+, AaDO2, AG, p50, nCa++ measured optical fluorescence and reflectance

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device Barometric pressure Analytical method(s) or technologies employed

Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Maximum No. of patient samples per hour/Maximum No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report Analyzer connections Interface standards supported How analyzer connects to external system to upload patient and QC results Information included in transmission from analyzer to external system Hardware and software for data management system No. of different management reports system produces Contents downloaded from data management system to analyzer System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces Distinguishing features (provided by company)
Note: a dash in lieu of an answer means company did not answer question or question is not applicable

yes 1 year/yes 57 years closed/no point-of-care testing and laboratory reagent 200500 analyses no special requirements reagents: 18 months (at room temperature); electrodes: up to 18 months 1 7 reagents and electrodes: 18 months; membrane kits: 1224 months <$0.08 at 40 analyses per day/$0.04 at 40 analyses per day 1 and 2 point (automatic) 1 point: 30 or 45 minutes or with every sample (user selectable); 2 point: 2, 3, 4, 5, or 6 hours (user defined) minimum CLIA recommendations L-J plots/comparable plot, statistical calculations, monthly cumulative report, onboard, available with external system no yes whole blood, capillary, mixed venous, arterial, venous heparin/aspiration and capillary 210 L yes, variety of micro-panel options offered and can be customized 61 seconds 32/224 190 tests per hour yes none yes weekly: <5 minutes; monthly: <10 minutes yes multilevel password with unique user ID number self-diagnosis software informs and notifies operator of HW and SW failure; hotline and field support options range from flagging to not reporting test to lockout for QC failure or exceeding scheduled QC interval any test that does not calibrate will not report results and instrument notifies operator of reason for failure operator and patient IDs yes/Ethernet, USB patient ID and accession numbers, entered settings, measured and calculated results directly to LIS/HIS, DMS that in turn connects to LIS/HIS ASTM E1394-91, ASTM 1381-91, HL7 modem dial-in, hospital network device unique identifier, operator and patient IDs, results, QC identifier full-featured onboard DMS capability, external DMS also available >30 valid control nos., valid operator IDs, patient demographics most analyzers interfaced to LIS using LIS vendors drivers

yes, Opti series 1 year (service contract available for subsequent years)/yes 7 years closed/no point-of-care testing and laboratory reagent/multi-use cartridge 4 50 room temperature cassette: 7 months; fluid pack: 12 months

2 8 cassette: 7 months; fluid pack: 12 months depends on volume 2 point (automatic) 1 point: after every sample or 30 minutes; 2 point: every 3 hours minimum CLIA recommendations; auto QC can be programmed to meet requirements /auto QC, statistics reports no yes plasma, serum, whole blood heparin/aspiration and capillary 125 L no ~1 minute 24/192 24 per hour no no weekly: 1 minute; quarterly: 5 minutes no bar code or secure PIN for 300 operators error message QC lockout error message with automatic retry operator and patient IDs, reagent, QC yes/RS-232, Ethernet patient ID, results, patient demographics (customized), critical ranges directly to LIS/HIS, DMS that in turn connects to LIS/HIS, Prism POC data manager ASTM, ASCII direct serial, Ethernet hospital network device unique identifier, operator and patient IDs, results, QC identifier, all information pertinent to patient and QC data Prism POC data manager 40 Meditech, McKesson, Cerner, Siemens, others

onboard QC cartridge provides sufficient QC three independent levels of automatic QC, stable materials for 30-day autmatic QC analysis; allows optical fluorescence technology, multiple-use user to program frequency and select report protocol cassette, low maintenance, and color touchscreen with full QC SMD

Tabulation does not represent an endorsement by the College of American Pathologists.

32 / CAP TODAY

August 2011

In vitro blood gas analyzers

Part 6 of 8 Opti Medical Systems Inc. Sales Department 235 Hembree Park Drive, Roswell, GA 30076 800-490-6784 www.optimedical.com OPTI CCA-TS Blood Gas Analyzer/2003/ 4.7 14.2 9 inches/12 pounds (10 lbs w/o battery) pH, pCO2, pO2, Na, K, Cl, iCa, tHb, SO2, glucose, BUN, lactate Hct, HCO3, BE, BEecf, BEact, BB, tCO2, st. HCO3, st. pH, O2ct, cH+, AaDO2, AG, p50, nCa++ measured optical fluorescence and reflectance Radiometer America Inc. Telesales Department info@radiometeramerica.com 810 Sharon Drive, Westlake, OH 44145 800-736-0600 www.radiometeramerica.com ABL90 FLEX/2010 in U.S./ //$40,000 17.7 9.8 11.4 inches/24 pounds pH, pCo2, p02, Hb, Na, K,Cl, iCa, lactate, glucose, sO2, tHb, FO2Hb, FCOHb, FMetHb, FHHb, FHbF Hct, BE, TCO2, HCO3, and 44 additional parameters recorded, measured pH, iCa, pCO2, lactate, glucose, Na, Cl, K: thick film, potentiometric analysis; pO2: optical phosphorescence; Hct: calculation; Hb: multi-wavelength CO-ox spectrophotometric analysis no 1 year (parts, labor, and travel) with service plans available after year one/yes 10+ years closed/no point-of-care testing and laboratory reagent, electrode (multiuse cartridge) 1 100, 300, 600, 900 small SC only needs refrigeration reagent/electrode system: four months 2 all reagent and sensor cartridge: four months depends on configuration/depends on configuration 1 and 2 point (manual and automatic) 1 point with each sample analysis; 2 point every 8 hours (user configurable) standard QC according to CAP, CLIA, JCAHO guidelines; user configurable for increased QC frequency L-J plots, comparable plot via DMS/auto QC (statistical calculations, monthly cumulative reports, on board and through DMS) yes whole blood, capillary, mixed venous, arterial, venous heparin, electrolyte-balanced heparin/aspiration, auto aspiration, capillary, test tube, micro-sample 65 L no 35 seconds 50/800 800 tests (equals 50 patient samples) yes yes monthly: as needed customizable user log-ons, bar code, on-board keyboard; built-in bar code scanner system message; traffic light; audible, visual signals, parameter bar traffic light; self-correcting when possible same as hardware/software failure same as hardware/software failure operator and patient IDs; uses smart-chips for reagents, no scanning needed yes/RS-232, parallel, Ethernet, others patient information and demographics, patient therapy settings, measured and calculated results, system messages, reference and critical values, analyzer set-up and configuration, and more directly to LIS/HIS; LIS/HIS, via data management system ASTM 1394, HL7, serial, POCT1-A, network, TCP/IP direct serial, hospital network device-unique identifier, operator and patient IDs, results, QC identifier, calibration and analyzer status internal system and external: RADIANCE and all other DMS systems standard and user definable reports valid operator IDs Cerner, McKesson, Meditech, Sunquest, many others no (an interfacing tool/engine could be used) fast results (35 seconds on 65 uL sample with 4455 per hour throughput); easy to use: walk-up ready; one-handed operation with integrated user guides and no user maintenance; automatic quality management supports regulatory compliance requirements, performs continuous checks and corrective actions are performed automatically Radiometer America Inc. Telesales Department info@radiometeramerica.com 810 Sharon Drive, Westlake, OH 44145 800-736-0600 www.radiometeramerica.com ABL 800 Series/2004/ //depends on configuration 22 28 21 inches/70 pounds pH, pCO2, pO2, Hb, Na, K, Cl, iCa, lactate, glucose, bilirubin, fetal Hb, O2Hb, MetHb, RHb, COHb, O2SAT, creatinine Hct, BE, TCO2, HCO3-, plus 40 additional parameters measured pH: pH-sensitive glass (ISE); pCO2, pO2, Na, Cl, iCa, K, ISE; Hct: calculated from measuring Hb, bilirubin; Hb: optical, multiwavelength analysis, intra-cuvette ultrasonic hemolysis, and more yes, ABL 800 series 2 years, parts, labor, and travel/yes 20 years, with full support closed/yes (low-pressure, premixed) point-of-care testing and laboratory 4 4 reagent, electrode, membrane kit, cartridge: 2+ years depends on sample volume and any extra included items/same 1 and 2 point (automatic) 1 point: 1/2 hour BG/pH, 4 hoursmanufacturer; 2 point: every 8 hours depends on hospital management and inspection agency L-J plots/comparable plot (via DMS), statistical calcs., automatic QC, monthly cumulative reports (onboard and available with external system) yes yes whole blood, capillary, mixed venous, arterial, venous, expired air heparin, electrolyte-balanced heparin/autoaspiration, syringe and/or capillary tube and/or test tube 95 L for 17 measured parameters yes, with fewer measured parameters, smaller micro-modes available from 35 L ~1 minute (depends on tests ordered) 25/425 25 per hour yes halothane, thiocyanic and glycolic acids yes monthly: as needed; annually: dependent on version yes customizable onboard keyboard, bar code system message with customized (traffic light) visual and audible signals, parameter status bar operator and patient IDs, reagent and QC lot numbers, expiration, software keys yes/RS-232, Ethernet/USB patient information/demographics, patient therapy settings, measures and calculates results, system messages, reference and critical ranges RADIANCE stat information management system that connects to LIS/HIS or directly to LIS/HIS ASTM, HL7, serial, POCT1A, network TCP/IP direct serial/thousands of hospitals installed; modem dial-in/hundreds; hospital network/hundreds; real-time wireless-capable device-unique identifier, operator and patient IDs, results, QC identifier, per ASTM/HL7 standards plus calibration and analyzer status information internal system plus optional external system, RADIANCE user-definable searches/reports Cerner, Meditech, Misys, others IDMS-traceable creatinine; FLEXQ automated inlet part of automatic system; bilirubin and fetal Hb measured on whole blood with no extra sample volume, low maintenance and cost of operation

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device Barometric pressure Analytical method(s) or technologies employed

Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Maximum No. of patient samples per hour/Maximum No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report

yes, Opti series 1 year (service contract available for subsequent years)/yes >7 years closed/no point-of-care testing and laboratory single-use cassettes 25 individual packaged cassettes 1 room temperature cassette: 612 months, depends on type 1 8 cassette: 68 months, depends on type depends on volume 1 point (automatic) with each cassette minimum CLIA recommendations; electronic QC can be used for daily QC requirements /electronic QC, statistics reports no yes plasma, serum, whole blood heparin/aspiration and capillary 125 L ~1 minute from sample aspiration 24/192 24 per hour no no, single use weekly: 1 minute; quarterly: 5 minutes no bar code or secure PIN for 300 operators error message QC lockout error message operator and patient IDs, reagent, QC yes/RS-232, Ethernet patient ID, results, patient demographics (customized), critical ranges

Analyzer connections Interface standards supported How analyzer connects to external system to upload patient and QC results Information included in transmission from analyzer to external system Hardware and software for data management system No. of different management reports system produces Contents downloaded from data management system to analyzer System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces Distinguishing features (provided by company)

directly to LIS/HIS, DMS that in turn connects to LIS/HIS, Prism POC data manager ASTM, ASCII direct serial, Ethernet hospital network device-unique identifier, operator and patient IDs, results, QC identifier, all information pertinent to patient and QC data Prism POC data manager 40 Meditech, McKesson, Cerner, Siemens, others stable optical fluorescence technology, easy-to-use touchscreen, measured tHb and SO2, no standby costs (single-use system), low maintenance

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.

August 2011

CAP TODAY / 33

In vitro blood gas analyzers

Part 7 of 8 Radiometer America Inc. Telesales Department info@radiometeramerica.com 810 Sharon Dr., Westlake, OH 44145 800-736-0600 www.radiometeramerica.com ABL80/2006/ //depends on configuration 16 9 11 inches/19 pounds pH, pCO2, pO2, Hct, Na, K, iCa, Cl-, Glu, Hb, O2SAT, O2Hb, COHb, MetHb, HHb Hb, O2SAT, TCO2, HCO3-, ctO2 (a-v), ctO2, anion gap (K+), cCa2+ (7.40), cBase (B), ABE, SBE, others pH, pCO2, pO2, Na, K, iCa, Cl, Glu: thick film; amperometric/potentiometric technology; HCT: conductivity yes 1 year, parts, labor, and travel, with service plans available after year 1/yes analyzer: 10+ years closed/no point-of-care testing and laboratory electrode (multi-use cartridge) 1 50/100/200/300 room temperature 90100 days 2 2 reagent: 100 days, cartridge: 90 days depends on configuration/same 1 and 2 point (manual and automatic) 1 point: with each test; 2 point: 8 hours (user definable) QC material according to CLIA, CAP, JCAHO L-J plots/statistical calculations, monthly cumulative (onboardcurrent mean, STD, CV%) reports (onboard and available with external system, PC download to Excel) yes yes whole blood, capillary, mixed venous, arterial, venous heparinized, electrolyte balanced heparin/aspiration 70 L no 90 seconds 30/270 30 tests per hour yes no no customizable onboard keyboard, bar code system message with customized (traffic light) visual and audible signals, parameter status bar operator and patient IDs, reagent and QC lot numbers, expiration, software keys yes/RS-232, Ethernet/USB patient information/demographics, patient therapy settings, measures and calculates results, system messages, reference and critical ranges Radiance stat analyzer management system that connects to LIS/HIS or directly to LIS/HIS ASTM, HL7, serial, network, TCP/IP serial, Ethernet device-unique identifier, operator and patient IDs, results, QC identifier Radiance user definable Cerner, Meditech, Misys, others no (use interface templates) portable, true battery operation; fast startup/ warmup and analysis time; simple and easy-to-use system Roche Diagnostics Tonya Sullivan tonya.sullivan@roche.com 9115 Hague Rd., Indianapolis, IN 46256 800-428-5076 www.mylabonline.com Roche cobas b 221 system/2004/ 23 20 23.6 inches/99 pounds (without solutions and AutoQC) pH, pCO2, pO2, Hct, Hb, Na, K, Cl, iCa, lactate, glucose, BUN, bilirubin, pH pleural fluid Hb, Hct, O2SAT, BE, TCO2, HCO3recorded or measured pH: electrode ion-selective galvanometric; pCO2, pO2: electrode ion selective membrane; Hct: conductivity; Hb: CO-ox spectrophotometry; Na, Cl, iCa, K: ion selective potentiometry; lactate, glucose, BUN: MSS sensor enzyme yes, three models in series 1 year (parts and services warranty)/no 7 years closed/no point-of-care testing and laboratory reagent and electrode depends on model, contact Roche dependent on use room-temperature storage 12 months (reagents)/18 months (electrodes) depends on model, contact Roche 3 reagent: 1 year; electrode: 18 months onboard volume-dependent/volume-dependent 1 and 2 point (automatic) 1 point: 30 minutes; two point: 8 hours CAP and JCAHO guidelines L-J plots/comparable plot, lot-to-lot comparisons, statistical calculations, monthly cumulative reports, onboard, eQAP yes yes plasma, serum, whole blood, capillary, arterial, venous EDTA, heparin, citrate/aspiration, injection, capillary transfer and fill, microsamples 200 L for full panel yes, BG: 40 L; ISE: 40 L; CO-ox 44 L, glucose, lactate, BUN: 75 L ~1 minute (test dependent) 30/360 30 patients per hour (full panel) yes yes daily: 2 minutes, monthly: 5 minutes, quarterly: 5 minutes yes 32-level password system (customizable) HW: identified onscreen and with diagnostic routine; SW: onscreen with messages onscreen report with high/low flagging, lockout capabilities onscreen reporting with lockout capabilities operator and patient IDs, reagent lot number, RF with transponders, expiration yes/RS-232, parallel, Ethernet options can be customized; direct and measured parameters cobas bge link, data management systems, LIS or HIS ASTM, HL7, USB port Ethernet device-unique identifier, operator and patient IDs, results, QC identifier cobas bge link 13 base reports, unlimited customized reports valid operator IDs Cerner, Meditech, others Data Innovations FDA-510(k)-cleared pH pleural fluid results; 42-day onboard reagent packs; Roche AutoQC with up to 40 days of QC covered; screen sharing and remote protected access with cobas bge link and Axeda software Siemens Healthcare Diagnostics Inc. 1717 Deerfield Road Deerfield, IL 60015-0778 800-255-3232 www.siemens.com/diagnostics RAPIDPoint 500 system (in development, not for sale in the U.S.)/2011/ 21.5 11.5 16 inches/36.5 pounds pH, pCO2, pO2, Hb, Na, K, Cl, iCa, glucose, neonatal total bilirubin (pending clearance), CO-oximeter fractions (fO2Hb, fCOHb, fMetHb, fHHb) O2SAT, BE, TCO2, HCO3 recorded pH, iCa, Na, Cl, K: potentiometry using ISE; pCO2: potentiometry based on severinghaus; pO2: amperometric; glucose: amperometric, glucose oxidase; Hb: spectrophotometric no 1 year/yes 710 years closed/no point-of-care testing and laboratory multi-use cartridge 1 measurement and 1 wash-waste cartridge; 1 AQC cartridge 250, 400, 750 samples measurement and AQC cartridge: refrigeration; wash/waste cartridge: room temperature 9 months 1 measurement and 1 wash-waste cartridge; 1 AQC cartridge 1 measurement and 1 wash-waste cartridge; 1 AQC cartridge cartridge: 9 months 1 and 2 point (manual and automatic) one point: 30 minutes; two point: 2 hours 1 AQC cartridge; fully user programmable L-J plots/external RAPIDComm Data Management, statistical calculations, monthly cumulative reports yes no whole blood, capillary, mixed venous, arterial, venous heparin/aspiration 100 L minimum no ~60 seconds 25/up to 325 25 samples per hour yes benzalkonium yes monthly: 1-minute cartridge replacement no password (customizable) diagnostic codes/diagnostic codes fully customizable flags diagnostic codes operator and patient IDs yes/RS-232, Ethernet operator and patient IDs, accession number, patient measured and calculated results, temperature, more directly to LIS/HIS, data management system, which connects to LIS/HIS LIS3 direct serial, Ethernet device-unique identifier, operator and patient IDs, results, QC identifier RAPIDComm Data Management system fully customizable valid control values and operator IDs no maintenance, multi-use cartridge; fast time to patient results and sample to sample throughput; 28-day, onboard, automatic quality control cartridge

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device Barometric pressure Analytical method(s) or technologies employed

Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features

Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Maximum No. of patient samples per hour/Maximum No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report

Analyzer connections Interface standards supported How analyzer connects to external system to upload patient and QC results Information included in transmission from analyzer to external system Hardware and software for data management system No. of different management reports system produces Contents downloaded from data management system to analyzer System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces Distinguishing features (provided by company)

Tabulation does not represent an endorsement by the College of American Pathologists.

34 / CAP TODAY

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In vitro blood gas analyzers

Part 8 of 8 Siemens Healthcare Diagnostics Inc. 1717 Deerfield Road Deerfield, IL 60015-0778 800-255-3232 www.siemens.com/diagnostics RAPIDPoint 300 Series/2009/ 12.5 14.5 7 inches/1617 pounds pH, pCO2, pO2, Hct, Na+, K+, Cl-, iCa++ Hb, 02SAT, BE, TCO2, HCO3 Siemens Healthcare Diagnostics Inc. 1717 Deerfield Road Deerfield, IL 60015-0778 800-255-3232 www.siemens.com/diagnostics RAPIDPoint 400 Series/2001/ 21.5 11.5 16 inches/34 pounds pH, pCO2, pO2, Hct, Na+, K+, Cl-, Ca++, tHB, FO2Hb, FCOHb, FMetHb, FHHb, glucose Siemens Healthcare Diagnostics Inc. 1717 Deerfield Road Deerfield, IL 60015-0778 800-255-3232 www.siemens.com/diagnostics RAPIDLab 1200 Series/2005/ 22.75 20.5 21 inches/6568 pounds

Name of device/First year sold/Number of analyzers sold in 2010 Number of devices sold in U.S./outside U.S./List price Dimensions (H x W x D)/Weight Analytes measured on device Parameters calculated on device

Barometric pressure Analytical method(s) or technologies employed

recorded, measured pH: ISE-potentiometry; iCa: ISE; PCO2: ISE-potentiometry; p02: ISE-amperometry; Hct: conductivity; Hb: calculated from hematocrit; Na: ISE; Cl: ISE; K: ISE yes, two models: RAPIDPoint 340 offers blood gas; RAPIDPoint 350 offers blood gas, electrolytes, and hematocrit 1-year warranty (country specific)/yes 710 years closed/no laboratory multi-use cartridge 1 based on daily testing volumes room temperature reagents: 7 to 9 months; electrodes: 12 months

Device is part of a series of related models Device warranty/Loaner devices provided Average life expectancy of device Open or closed system/External gas tanks required Categorized for point-of-care testing or laboratory Point of care: Disposable prepackaged system used for analysis No. of disposable reagent system units in standard package No. of samples analyzed per one disposable reagent, electrode system Reagent unit storage requirements Shelf life of disposable units 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 Calibration frequency Internal QC program recommended QC features/Capabilities of QC features Remote control of device from laboratory System can use LOINC to transmit results to LIS Specimen types suitable for device Acceptable anticoagulants/Sampling technique Sample size for complete panel of analyte results Sample size differs with number of analytes selected Time from sample introduction to result availability Maximum No. of patient samples per hour/Maximum No. measured results per hour Optimal throughput when analyzer calibrated, awaiting specimens Calibration can be interrupted to perform stat sample Known interferences Sampler has self-wiping probe Time required for maintenance by lab personnel Service center performs diagnostics through modem Method of analyst ID in system Instrument response for: hardware failure/software failure QC failure calibration failure For what bar-code scanning is provided Built-in printer/Data port Information listed on hard copy report Analyzer connections Interface standards supported How analyzer connects to external system to upload patient and QC results Information included in transmission from analyzer to external system Hardware and software for data management system No. of different management reports system produces Contents downloaded from data management system to analyzer System connected (live installations) to which LISs, HISs Use a third-party interfacing tool, engine for LIS, HIS interfaces Distinguishing features (provided by company)

pH, pCO2, pO2, tHb, Na+, K+, Cl-, iCa++, lactate, glucose, FO2Hb, FCOHb, FMetHb, FHHb, total neonatal bilirubin HCO3-act, HCO3-std, BE(B), BE(ecf), ctCO2, HCO3-act, HCO3-std, BE(B), BE(ecf), ctCO2, Ca++(7.4), RI(T), O2SAT, PO2/FIO2, AnGAP, sO2, BO2, Ca++(7.4), RI(T), O2SAT, PO2/FIO2, AnGAP, sO2, BO2, pO2(A-a)(T), pO2(a/A)(T), p50, Qsp/Qt(T), ctO2(Hb), pO2(A-a)(T), pO2(a/A)(T), p50, Qsp/Qt(T), ctO2(Hb), ctO2(a), ctO2(v), ct02(V), ctO2(a-v), DO2, VO2, others ctO2(a), ctO2(v), ct02(V), ctO2(a-v), DO2, VO2, others recorded measured, tracked pH: potentiometry; pCO2: Severinghaus pH, Na, Cl, iCa, K: potentiometry using ISE; pCO2: potentiometry based on Severinghaus; pO2: electrochemical; pO2: amperometric; Hct: calculated; amperometric meas. (Clark); glucose: amperometric- tHb: spectrophotometric; Na, Cl, iCa, K: ISE; lactate: glucose oxidase; Hct: conductivity; CO-oximetry: lactate oxidase; glucose: glucose oxidase; total neonatal bilirubin: spectrophotometric spectrophotometric yes yes, series offers different analyte options 1 year/yes 710 years closed/no point-of-care testing and laboratory multi-use cartridge 1 measurement and 1 wash-waste cartridge 250, 400, 750 samples refrigeration 9 months 1 year/no 710 years closed/no point-of-care testing and laboratory multi-use cartridges, electrode measurement chamber 1 reagent cartridge, 1 wash cartridge Reagent cartridge is not sample dependent Reagent cartridge/AQC cartridgerefrigeration; wash cartridgeroom temperature reagent/wash cartridge: 8 months; AQC cartridge: 9 months; electrodes: varies based on type 1 reagent cartridge, 1 wash cartridge 1 reagent cartridge, 1 wash cartridge, all electrodes electrodes: vary based on type; reagent cartridge: 8 months; wash cartridge: 8 months; AQC cartridge: 9 months varies based on configuration 1 and 2 point (manual and automatic) 1 point: every 30 minutes; 2 point: every 8 hours AQC cartridge, fully user programmable L-J plots/comparable plots, statistical calculations, monthly cumulative reports (available with external system) yes no whole blood, capillary, mixed venous, arterial, venous heparin/aspiration 95175 L yes (microsample mode available) 60 seconds 24/up to 336 tests 24 samples per hour yes yes weekly: 5 minutes; monthly: 5 minutes no password (customizable) diagnostic codes prompt the operator diagnostic codes recalibrates, generates diagnostic code if unsuccessful patient ID yes/RS-232, Ethernet operator and patient IDs, accession number, results, temperature, patient demographics, others data management system, which connects to LIS/ HIS; directly to LIS/HIS (both options) LIS 4 direct serial, hospital network device-unique identifier, operator and patient IDs, results, QC identifier RapidComm Data Management System customizable valid control values, valid operator IDs yes cartridge-based high-throughput analyzer with minimal maintenance; fast time to patient results; onboard troubleshooting tutorials

1 1 reagents: 79 months; electrodes: 12 months varies based on configuration and test volume/ 1 and 2 point (manual and automatic) 1 point (with each sample); 2 point (can be set to 2-, 4-, or 8-hour increments) one-level QC every 8 hours of testing (CLIA recommendation): Siemens QC material recommended L-J plots/statistical calculations, monthly cumulative reports, onboard no no whole blood, capillary, mixed venous, arterial, venous heparin/aspiration 75 L/95 L capillary (RP340/RP350) 100 L/120 L syringe (RP340/RP350) no 125 seconds (RP340), <120 seconds (RP350) 25 samples (RP340), 30 samples (RP350)/75 (RP340), 210 (RP350) 25 samples per hour (RP340), 30 samples per hour (RP350) yes certain anticoagulants yes daily: <1 minute no manual or bar-code entry (optional) operator warning, error messages sampling lock-out, flagged high or low QC results automatic calibration repeat, error messages, blank screen display operator identifier, patient identifier, and reagent lot number yes/RS-232 patient information, operator ID, measured and calculated results, date directly to LIS/HIS ASTM 1394 and E1381 direct serial operator ID, patient ID, results internal data management patient reports, QC statistics, L-J charts no multi-use cartridge-based system eliminates gas tanks; no maintenance, easy-to-replace electrodes; small, portable, and economical; dialysate fluid testing application in select countries

1 measurement cartridge, 1 wash-waste cartridge 1 measurement cartridge, 1 wash-waste cartridge 9 months varies based on configuration 1 and 2 point (automatic) 1 point: 30 minutes; 2 point: 2 hours AQC cartridge, fully user programmable AQC cartridge, L-J plots/comparable plots, statistical calculations, monthly cumulative reports (available with external system) yes no whole blood, capillary, mixed venous, arterial, venous heparin/aspiration 100 L no 60 seconds 25/ 25 samples per hour yes benzalkonium yes none no password (customizable) flag-prompt customizable-flag flagrecalibration operator and patient IDs, accession number results, temperature, other information yes/RS-232, Ethernet operator and patient IDs, accession number results, temperature, other information data management system, which connects to LIS/ HIS; directly to LIS/HIS (both options) LIS 3 direct serial, hospital network device-unique identifier, operator and patient IDs, results, QC identifier RapidComm Data Management System customizable valid control values, valid operator IDs yes no maintenance, multi-use cartridge; fast time to patient results; onboard audio-video training videos; auto QC

Tabulation does not represent an endorsement by the College of American Pathologists.