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tech guide

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Technology Guide Blood Gas Analyzers


Alere inc Product epoc

insTrumenTATion lABorATory GEM Premier 4000 critical care analyzer

novA BiomedicAl Stat Profile pHOx

Web site Sample volume

www.alere.com 92 L

www.ilus.com 65 L micro mode, 100 L CO-Ox/Total Bilirubin, 135 L full menu Automated continuous with iQM 70 seconds for electrochemical and 25 additional seconds for CO-Ox Measured: pH, Pco2, Po2, Na+, K+, Cl-, iCa++, Glu, Lact, Hct, tHb, COHb, HHb, MetHb, O2Hb, Total Bilirubin; Calculated: 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(c), Hco3- std, Hco33- (c), AaDO2, Pao2/Pao2, RI, CcO2, a-vDO2, Qsp/Qt(est), Qsp/Qt 90 seconds 12C to 32C (53.6F to 89.6F) Whole blood, capillary, mixed venous, arterial, venous

www.novabiomedical.com 45 L to 125 L 3 to 5 minutes 45 to 52 seconds

Calibration time Measurement time

~170 seconds ~35 seconds

Analytes calibration/measurement

Measured: pH, Pco2, Po2, Hct, Na, K, iCa, Lactate, Glucose; Calculated: Hgb, O2SAT, BEb, BEecf, tco2, Hco3

pH, Po2, Pco2, SO2%, Hct, Hb, Na+, K+, Cl, Ca, Glu, Lac

Typical cycle time Operating temperature Sample type

~30 seconds 15C to 30C (59F to 86F) Heparinized or un-anticoagulated arterial, venous, or capillary whole blood pH, iCa, Pco2, Na, K: potentiometry; Po2, lactate, glucose: amperometry; Hct: conductometry

Throughput of 40 to 50 samples per hour Ambient operating temperature is 15C to 30C (59F to 86F) Whole blood, arterial, mixed venous, venous, capillary, serum/plasma Direct ISE, Severinghaus, Optical, Conductivity, Enzyme/Amperometric

Measurement principle

Electrochemical, conductivity, CO-Ox

Sample application

Injection

Syringe, capillary, tube, ampoule

Syringe, tube, capillary tube (no adapter required) All quality control data is automatically stored. Daily and cumulative statistical reports and Levey-Jennings graphs can be printed at any time. Multilevel password with unique user ID No. Yes 15 12 15 18 pounds

Data storage

Data Management System, Database and Web Server Security Yes Yes 3 x 3.4 x 8.5 ~1.5 pounds Reader: AC input: 100-240 Vac, .5 amps, 50-60 Hz; DC output: 5 volts, 3 amps; Host: Input: 100-240 Vac, 50/60 Hz, 500 mA; Output: 5 Vdc, 3000 mA DC output: 5 volts, 3 amps HL7

100 MB (unlimited patient samples)

Password security QC Lockout dimensions/ Weight Height x width x depth (inches) Weight

Yes User definable QC and new lot lockout options 18 x 12 x 15 44 pounds 100 VAC/3 Amps Voltage - /Freq - 50/60 Hz 300 VA ASTM1394/HL7

Voltage/frequency

90-264 VAC, 50/60 Hz

Power consumption (max) miscellaneous Interface

200 W RS232 serial communication and HL7 ASTM Standard data protocols, HL7 on TCP/IP, USB ports ISO 13485; 2003, ISO 9001; 2000 Quality System, Registration, CSA, TV, IVDD CE Self Declared, CSA, TV. Complies to EN 61010, EN 50081,82

Approvals

FDA 501(k) clearance on epoc System and all analytes represented

CE, CSA, EMC Emissions and Immunity, European Union Directive 2002/96/EC on WEEE, CEI/IEC 61010.1, FDA iQM detects, corrects, and documents instrument errors, reducing error detection time to minutes; single component, multi-use PAK 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.

other Features

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).

Onboard auto-cartridge QC; all-liquid calibration cartridge eliminates gas tanks; single reagent cartridge has all supplies for calibration and waste collection.

Technology Guide Blood Gas Analyzers


NovA BiomedicAl Product Stat Profile pHOx ULTRA

oPTi medicAl OPTI CCA-TS analyzer

siemeNs heAlThcAre diAGNosTics iNc RAPIDPoint 500 system

Web site Sample volume Calibration time Measurement time

www.novabiomedical.com 60 L to 210 L 3 to 5 minutes 1 to 2 minutes

www.optimedical.com 125 L for most cassettes, 60 L cassette available ~1 minute ~1.5 minutes

www.siemens.com/diagnostics Max no. of patient samples per hour/max no. measured; results per hour 25/up to 325; sample size 100 L minimum 1 and 2 point (manual and automatic); 1 point: 30 minutes; 2 point: 2 hours ~60 seconds to result

Analytes calibration/measurement

pH, Po2, Pco2, SO2%, Hct, Hb, Na, K, Cl, Ca, iMg, Glu, BUN, Creat, Lac, CO-Ox (HHb, O2Hb, COHb, MetHb, tBil)

pH, Pco2, Po2, tHb, So2, Na+, K+, iCa, Cl-, glucose, lactate, and BUN (in various test configurations)

pH, Pco2, Po2, Hb, Na+, K+, Cl-, iCa, glucose, neonatal total bilirubin, COOXimeter fractions (fO2Hb, fCOHb, fMetHb, fHHb)

Typical cycle time Operating temperature Sample type

Throughput up to 38 samples per hour Ambient operating temperature is 15C to 30C (59F to 86F) Whole blood, arterial, mixed venous, venous, capillary, serum/plasma Direct ISE, Severinghaus, Amperometric, Optical, Conductivity, Enzyme/ Amperometric Syringe, tube, capillary tube (no adapter required) Onboard data management

~2.5 minutes 10C to 32C (50F to 90F) Whole blood, serum, plasma

~60 seconds 15C to 32C (59F to 90F) Whole blood pH, iCa, Na, Cl, K: potentiometry using ISE; Pco2: potentiometry based on Severinghaus; Po2: amperometric; glucose: amperometric, glucose oxidase; Hb: spectrophotometric Specimen types suitable for device: whole blood, capillary, mixed venous, arterial, venous, heparin/aspiration RAPIDComm Data Management system

Measurement principle

Optical fluorescence and reflectance

Sample application

Syringe or capillary by automatic aspiration Holds 200 patient records and 1 month of QC on board. Password protected setup and operation, holds up to 300 secure operator IDs/PINs. User definable QC and new lot lockout options 5 x 14 x 9 12 pounds with rechargeable battery

Data storage

Password security QC Lockout dimensions/ Weight Height x width x depth (inches) Weight

Multilevel password with unique user ID No. Yes 17.2 22.4 17.3 53 pounds

Yes Yes 21.5 11.5 16 36.5 pounds

Voltage/frequency Power consumption (max) miscellaneous Interface

90-264 VAC, 50/60 Hz 350 W RS232 serial communication and HL7 ASTM Standard data protocols, HL7 on TCP/IP, USB ports ISO 13485; 2003, ISO 9001; 2000 Quality System, Registration, CSA, TV, IVDD CE Self Declared, CSA, TV, Complies to EN 61010, EN 50081,82 Large whole blood critical care menu (20 tests), BUN, ionized Mg available exclusively from Nova; onboard co-oximeter; onboard QC cartridge provides sufficient QC materials for 30-day auto QC analysis; allows user to program frequency and select report protocol.

120 or 240 AC/50-60 Hz 110 VA Ethernet, serial (ASTM or ASCII)

n/a n/a Ethernet and RS232 via the Siemens communication protocol LIS3 and serial RS232 option

Approvals

CE, UL, IVDD

FDA approved

other features

Single use measurement cassette with automatic sample aspiration; color touch screen interface; barcode scanner; heated measurement for cold environments.

No maintenance, multi-use cartridge; fast time to patient results and sample to sample throughput; 28-day, onboard, automatic quality control cartridge.

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Technology Guide Blood Collection Tubes and Syringes


rna mediCal 220 L capillary blood collection tube, for the measurement of pH, blood gasses, and electrolytes (excluding lithium) rna mediCal 95 L capillary blood collection tube with plunger, designed for use with i-STAT chemistry cartridges requiring either 95 L or 65 L of sample SarSTedT inC SarSTedT inC Product Blood Gas Monovette arterial blood gas syringe Blood gas capillary tubes

Web site material

www.rnamedical.com Mylar-wrapped glass

www.rnamedical.com Mylar-wrapped glass Used for either 65 L or 95 L sampleporous plug positioned at the 95 L mark can be repositioned to accommodate a 65 L sample

www.sarstedt.com Tube: polypropylene

www.sarstedt.com Break-resistant, flexible, PET plastic with low gas permeability for safe collection and accurate test results. 2.05 mm x 100 mm, 100 L; 2.05 mm x 110 mm, 125 L; 2.30 mm x 75 mm, 140 L; 2.30 mm x 100 mm, 175 L

dimensions and volume

Volume

220 L with line markings at 55, 110, and 165 L fill (approximately)

1 mL and 2 mL volumes

Outer dimension

.075 inches

.095 inches

11 mm

See above

Length anti-coagulant

5 inches Yes

2.95 inches Yes

66 mm Calcium-balanced lithium heparin

See above Calcium-balanced lithium heparin

Concentration

Approximately 70 IU per mL of whole blood sample

Approximately 70 IU per mL of whole blood sample

50 IU/mL

70 IU/mL

Form

Calcium balanced lithium heparin

Calcium balanced lithium heparin

Fine dispersion of liquid calciumbalanced heparin, resulting in a large surface area for good solubility and quick mixing to ensure accurate results.

Coated on inside of capillary

Closure type

End cap available for closure on 220 L tube; closures are fitted over one or both ends of the Safe Wrap tubes after sample collection, containing the sample and minimizing sample loss; the closures (end caps) are blue in color, are made from PVC, and contain no latex. Mylar wrapping. The Mylar wrapping (puncture-resistant film) serves to minimize the risks associated with broken glass capillaries, including glass cuts and aerosol formation, by containing both the glass and the sample in the event of accidental breakage.

N/A

Screw cap

Secure and flexible TPE caps; caps have flat grip areas for easy handling and to prevent capillaries from rolling if placed on a flat surface.

Safety features

Mylar wrapping. The Mylar wrapping (puncture-resistant film) serves to minimize the risks associated with broken glass capillaries, including glass cuts and aerosol formation, by containing both the glass and the sample in the event of accidental breakage.

Blood gas syringes are individually wrapped and sterile. Syringes do not include a needle or blunt cannula and therefore may be used with the facilitys preferred safety sharp.

Break-resistant, flexible plastic capillaries and stopper caps designed to prevent rolling.

Other features

N/A

Plunger for easy sample dispensing

Syringes feature graduations for volume confirmation and lot number and expiration date for traceability. A ventilation filter cap is available separately or pre-assembled on the 2 mL version for the hygienic and contamination-free removal of air from the syringes after blood collection. The ventilation filter cap also serves as a closure for transport to the analyzer.

Sarstedt blood gas capillaries, caps, and mixing wires are available separately or bundled together in convenient kits.

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