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December 2004

Blood Gas/pH Analyzers

Purpose

Blood gas/pH analyzers measure pH, PO2, andPCO2, typically in an arterial blood sample. They areused in respiratory therapy departments, clinical andcardiopulmonary laboratories, critical care units, sur-gical suites, physician offices, and hospital nurseriesto monitor patients’ acid-base balance and oxygen (O2)-carbon dioxide (CO2) exchange, providing the clinician

with information to use in patient diagnosis and regu-lation of therapy.

During respiration, there is an exchange of O2 andCO2 between the pulmonary capillaries and the alveoliin the lungs. O2 enters the bloodstream and is boundto and transported by the hemoglobin in red blood cells;a small amount of O2 dissolves in the plasma. O2

dissociates from hemoglobin, enters the tissues, and isused during cellular metabolism. CO2, a waste productof metabolism, is transported back to the lungs incombination with water in the form of bicarbonate(HCO3

-), dissolved in plasma, or joined with the aminogroups on the hemoglobin molecule.

Values for PO2 and PCO2 reflect the concentrationsof these gases in arterial blood. The normal arterial

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Scope of this Product ComparisonThis Product Comparison covers blood gas analyz-ers that directly measure the pH, the partial pres-sure of oxygen (PO2), and the partial pressure ofcarbon dioxide (PCO2) of an externally drawn orin-line blood specimen. Some blood gas analyzersalso provide additional calculated parameters andelectrolyte, chemical, and hematologic determina-tions (e.g., glucose, hematocrit). Several analyzersare portable, point-of-care (POC) models that areused at the patient bedside; for more informationon POC analyzers, see the Product Comparisontitled POINT-OF-CARE ANALYZERS, BLOOD GAS/PH; CHEMISTRY; ELECTROLYTE.

UMDNS informationThis Product Comparison covers the followingdevice terms and product codes as listed in ECRI’sUniversal Medical Device Nomenclature System™(UMDNS™):

• Analyzers, Laboratory, Blood Gas/pH [15-709]

• Monitors, Bedside, Blood Gas/pH, Extracor-poreal [17-680]

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PO2 value (for an adult under 60 years old who isbreathing room air) is between 80 and 100 mm Hg. Inhypoxemia, values below this range may be caused bybronchial obstruction, blood vessel or hemoglobin ab-normalities, decreased cardiac output, increased O2

demand, anatomic heart defects, impaired CO2 elimi-nation, or low inspired O2. Generally, PO2 levels above100 mm Hg are not found in patients who are breathingroom air; when they do occur, they do not contributesignificantly to the O2 content because — with normalhemoglobin concentrations — PO2 between 80 and 100mm Hg provides a 97% saturation level, and a levelgreater than 100% cannot be achieved.

Normal arterial PCO2 is between 35 and 45 mm Hg;values below this range, known as hypocapnia, are theresult of hyperventilation or an overrapid rate of me-chanically assisted respiration. Elevated PCO2 valuesconstitute hypercapnia, which is caused by such condi-tions as cardiac arrest, chronic obstructive lung dis-ease, depression of respiration by drug overdose,increased metabolic rate (e.g., fever), or chronic meta-bolic acid-base disturbances.

The pH of plasma reflects its concentration of hydro-gen ions (H+) and has a normal range of 7.35 to 7.45,which indicates that the body’s acid production andelimination functions are in homeostatic equilibrium.H+ are constantly released by acids through normalmetabolism; excess H+ are buffered by bicarbonates inthe plasma. The kidneys excrete the appropriateamounts of acids and bases to keep the pH constant.The respiratory system also influences pH by increas-ing or decreasing the rate of ventilation.

Acid-base disturbances are respiratory or metabolicin nature and result from conditions in which acids orbases are gained or lost from the body. Metabolicacidosis is characterized by a decrease of HCO3

- in theblood plasma. The body responds to this condition byincreasing the ventilation rate, excreting acid, andconserving HCO3

-. Causes of metabolic acidosis in-clude shock, renal failure, tubular acidosis, diabeticacidosis, and diarrhea.

In contrast, metabolic alkalosis is caused by anincrease of HCO3

- in the plasma. Compensation for thiscondition takes the form of moderate CO2 retention bythe lungs through hypoventilation and decreased reab-sorption of bicarbonate by the kidneys. Commoncauses of metabolic alkalosis include vomiting or na-sogastric suction, diuretic therapy, and excessive al-kali ingestion.

Decreased pulmonary ventilation increases thePCO2, which leads to increased levels of carbonic acidand H+, resulting in respiratory acidosis (decreased

pH). In cases of chronic respiratory acidosis (as withchronic pulmonary disease), the kidneys compensateby excreting H+ and conserving HCO3

-. Respiratoryacidosis can be caused by depression of the respiratorycenter, respiratory tract obstruction, and other condi-tions that limit ventilation and interfere with theexchange of gases between the blood and alveolar air.

Respiratory alkalosis is characterized by increasedCO2 elimination (hyperventilation) and can be acute orchronic in nature. It is caused by conditions such ashysteria, fever, central nervous system infection, hy-poxia, and salicylate or catecholamine ingestion — allof which stimulate the respiratory center.

Principles of operationBlood gas analysis involves the direct measurement

of pH, PO2, and PCO2 and can include the followingcalculated parameters: HCO3

-, standard bicarbonate(SB), buffer base (BB), base excess (BE), base excessextracellular fluid (BEecf), percent O2 saturation (SO2),O2 content (ctO2), and total CO2 concentration (ctCO2).In most systems, the arterial blood sample is anaero-bically drawn into a heparin-coated syringe, sealed,labeled, and transported to the laboratory for promptanalysis; one instrument, however, can analyze onlyfresh capillary blood. Some models can be transportedto the bedside or other location to perform analyseswithin minutes.

Blood gas analyzers use three types of electrodesystems to determine pH, PCO2, and PO2 in the blood.Because temperature changes affect measured values,the electrode systems and the sample chamber arelocated inside a temperature-controlled block main-tained at 37°C (normal body temperature).

Before the introduction of blood samples, the ana-lyzer’s electrode outputs are calibrated with knownconcentrations of standard buffers and calibrated so-lutions. In some analyzers, a high-pH standard bufferand low-pH standard buffer are alternately passedinto the sample chamber, and the corresponding pHelectrode responses establish upper and lower pointson a linear pH curve. Similarly, for gas calibration, gasmixtures with high and low concentrations of O2 andCO2 are alternately admitted to the sample chamber,and the O2 and CO2 electrode responses are used to sethigh and low points of the PO2 and PCO2 curves. Someanalyzers are calibrated before each test by solutionsin their reaction cartridges.

Calibrations are usually referred to as being one- ortwo-point, adjusting the electrode response at one level(either high or low) or at two levels (both high and low),respectively. One-point calibrations are most common.

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Blood gas/pH analysis begins as a blood specimen isinjected or aspirated into the sample chamber formeasurement. Some units momentarily delay analysisuntil temperature equilibration occurs; other instru-ments begin analysis before the sample and devicetemperatures reach equilibrium. Typically, when theblood sample contacts the electrodes in the chamber,it produces an electrical output that corresponds toeither a pH value or a partial pressure. Automatedblood gas analyzers monitor the electrode responsecontinuously and, after a predetermined stabilizationperiod, display and/or print the measured values.When analysis is complete, the blood specimen is dis-posed of in one of two ways. Most analyzers pump thespecimen into a waste container, and the system isflushed with a rinse or wash solution. Some newerunits retain the specimen in the sealed reaction car-tridge, which is then discarded.

The pH measurement is performed using two sepa-rate electrodes: a pH-measuring electrode and a refer-ence electrode (see Fig. 1). Each electrode represents ahalf-cell in which an electrical potential is developed.The measurement electrode is a silver-silver chlorideelectrode surrounded by a solution of constant pH andenclosed by a glass membrane sensitive to H+. As thesample passes the glass membrane, the difference inH+ concentration on either side of the membranechanges the potential (voltage) of the electrode. Thereference electrode, either a calomel (mercurous chlo-ride) or silver-silver chloride electrode, produces a con-stant potential regardless of sample pH. A saturatedelectrolyte solution (potassium chloride) in the refer-ence electrode and a leaky membrane permit currentflow from the reference electrode through the samplein the measurement chamber to the measuring elec-trode. The potential difference is displayed on a volt-meter calibrated in pH units.

The PCO2 electrode system uses principles similarto those for pH measurement (see Fig. 2). It employs

a Severinghaus PCO2 electrode, which combines aglass pH-measuring electrode and a silver-silver chlo-ride reference electrode. A membrane permeable toCO2 but not to H+ separates the sample from themeasuring system. The PCO2 electrode also containsa spacer (usually a porous membrane of Dacron ornylon) that acts as a support for an aqueous HCO3

-

layer. As CO2 diffuses through the membrane and intothe support, the pH of the electrolyte changes becauseof the change in carbonic acid concentration as follows:

The output of this modified pH electrode is propor-tional to the PCO2 present in the sample.

PO2 is measured by using a polarographic electrodesystem consisting of a platinum cathode (in the centerof a glass rod) and a silver-silver chloride anode. AnO2-permeable membrane separates the blood samplefrom the measuring system (see Fig. 3). O2 that dif-fuses through the membrane is reduced at the cathodewhen a 0.7 V potential is applied between the anodeand cathode (polarizing voltage). The following reac-tion represents the reduction occurring at the cathode:

The circuit is completed when silver is oxidized atthe anode:

The current developed by these reactions is directlyproportional to the PO2 of the sample.

Blood gas/pH analyzers can also correct results tothe temperature of the patient at the time of specimencollection. Other parameters, such as hemoglobin andfraction of inspired oxygen (FiO2), can be input to helpwith instrument calculations. Additional parametersare derived from calculations using pH, PO2, and PCO2

values. Patient and operator identifications are alsocommonly entered on several units. Analyzers withcomputer interfaces can transfer this data automat-ically to the laboratory information system (LIS) orcentral hospital computer system. Some analyzers canprint hard copies of the data using ticket printers.Some newer POC and handheld analyzers have datamanagement systems.

In addition to electrochemical blood gas/pH analyz-ers, in-line (extracorporeal) monitors that connect tothe patient’s existing arterial line are also available.These devices consist of a sensor, an arterial blood gas(ABG) module, and a monitor.

The sensor connects to the patient’s arterial line,and blood is drawn into the sensor. Fluorescent dyesin the sensor detect the pH, PO2, and PCO2 levels andtransmit light of a specific wavelength through a

MeasuringElectrode

ReferenceElectrode

SamplePath Glass Membrane

Solution ofConstant pH

LeakyMembrane

KClSolution

Calomel or Ag/AgClElectrode

Ag/AgCl Electrode

C22

1UN

2G

Figure 1. pH electrode system

H2O + CO2 → H2CO3 → H+ + HCO3−

O2 + 2H2O + 4e− → 4OH−

4Ag → 4Ag+ + 4e−


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fiberoptic cable to the instrument. The ABG moduleemits excitation energy, which is absorbed by the dyes.The dyes then emit light of a longer wavelength andtransmit it to the instrument through the cable. Theparameters are then determined by the difference inthe two wavelengths.

Results are typically available in about one minute,and new samples can be taken every few minutes. Theblood used for the tests is returned to the patientthrough the arterial line after it is used. The resultsare displayed on a screen, which can usually be inter-faced with a bedside monitor to integrate a variety ofphysiologic parameters.

A similar technique which does not require theremoval of blood from the patient is known as continu-ous intravascular blood gas monitoring. This tech-nique uses electrochemical and optical detectionmethods; however, the measurements are taken invivo as blood naturally passes over the monitor situ-ated in either the radial or femoral artery. Measure-ments are taken real-time, virtually continuously. Themonitor can be left in place for several days, if neces-sary, and allow withdrawal of arterial blood as well asinfusion of drugs through the arterial catheter.

Reported problemsECRI recommends that operators exercise extreme

caution when testing blood specimens and use univer-sal precautions, such as wearing gloves, a gown, and aface shield, when handling samples. In the UnitedStates, the Occupational Safety and Health Admini-stration (OSHA) requires workers to wear gloves whenhandling any laboratory specimen. OSHA also re-quires healthcare facilities to minimize risk of em-ployee exposure to HIV and hepatitis; free hepatitisvaccinations must be provided for all employees ex-posed to blood. In addition, laboratory workers shouldfollow the NCCLS — The Clinical Laboratory Stand-ards Organization guideline that describes the proper

safety procedures for handling potentially infectiousbody fluids (see Standards and Guidelines).

Because the waste generated by blood gas analyzerscontains blood, it should be handled as potentiallyinfectious material. Users should contact the manufac-turer of a given analyzer to determine which disinfec-tants are safe to use with each instrument. The liquidwaste containing blood, disinfectant, and spent re-agent should be disposed of according to state and localmedical waste regulations.

Once drawn, blood samples should be analyzedpromptly because delays in analysis can change themeasured values in several ways. Cellular componentsof the blood continue to metabolize O2, thereby lower-ing PO2 and pH levels and raising PCO2 levels. Speci-mens should be stored in plastic syringes and analyzedwithin 15 minutes; if they cannot be examined withinthis time, they should be collected in a glass syringeand iced until they can be analyzed. Samples in plasticsyringes should not be iced because it may cause anerroneously high PO2 value (Toffaletti 2001).

Other potential problems that can affect test resultsare room-air contamination of the samples and inade-quate sample mixing. Because air contamination canchange blood gas values, the syringe tip must becapped after any air bubbles are removed. Moreover,samples should be thoroughly mixed before analysis toensure the proper diffusion of gases through the elec-trode membranes.

Although blood gas analyzers directly measure PO2,PCO2, and pH and calculate HCO3

- and total CO2 directlyfrom the PCO2 and pH, the remaining parameters (e.g.,SO2, ctO2) are based on assumptions that may be incor-rect and thus yield erroneous results. The blood gasanalyzer does not account for variations in the oxyhemo-globin dissociation curve and assumes that all the hemo-globin is available to bind with O2. (The total hemoglobinincludes the functional hemoglobins [oxyhemoglobin

SamplePath O -Permeable

Membrane

Ag/AgCl ReferenceElectrode (anode)

Platinum Wire(cathode)

Electrolyte

2

C22

1UN

2I

SamplePath

CO -Permeable Membrane

SpacerElectrolyte

Ag/AgCl ReferenceElectrode

AgCl ElectrodeBufferGlass

Membrane

C22

1UN

2H

2

Figure 2. PCO2 electrode system

Figure 3. PO2 electrode system



and deoxyhemoglobin] and the dysfunctional hemoglo-bins [methemoglobin, carboxyhemoglobin, and sulf-hemoglobin]). When dysfunctional hemoglobins arepresent, blood gas analyzers can produce grossly erro-neous SO2 and ctO2 values. Certain pathologic condi-tions such as lipemia and hemolysis cannot be detectedin whole blood samples. Some substances (e.g., drugs)can interfere with the measurement of electrolytes andother analytes. In addition, improper instrumentmaintenance can cause inaccurate results.

The following procedures can improve the reliabilityof derived parameters: (1) interfacing the blood gasanalyzer with a multiwavelength oximeter (more com-monly called a co-oximeter), (2) using the blood gasanalyzer to determine the hemoglobin from a measuredhematocrit value (not all models have this feature), or(3) having the operator enter the total hemoglobinvalue. Interfacing the blood gas analyzer with anoximeter is the most accurate method because theoximeter can measure total hemoglobin and oxyhemo-globin and thus calculate reliable SO2 and ctO2 values.(Oximeters can also calculate the fractional O2 satura-tion [percent of oxyhemoglobin], which is obtained bydividing oxyhemoglobin by the total hemoglobin). Theother two options do not satisfactorily improve thereliability of derived parameters because they still yieldapproximated SO2 and ctO2 values based on the bloodgas analyzer’s assumptions concerning the oxyhemo-globin dissociation curve and total hemoglobin. Con-sidering these findings, the ability of a blood gasanalyzer to interface with a co-oximeter or the inclusionof an integral oximeter with the system becomes animportant consideration when purchasing new equip-ment. For more information, see the Product Compari-son titled OXIMETERS, IN VITRO, LABORATORY.

Purchase considerationsECRI recommendations

The accompanying comparison chart includesECRI’s recommendations for minimum performancerequirements for blood gas/pH analyzers. These rec-ommended specifications have been categorized intotwo groups: (1) analyzers used in the central or mainlaboratories and (2) analyzers used in specialty areasor as stat analyzers. The specifications have been ratedusing three categorizations: Required, Preferred, andOptional. A rating of Required indicates that thisspecification is the minimum necessary for the ana-lyzer to perform its indicated function. A rating ofPreferred is used for specifications that enhance eithertest parameters or ease of use and therefore effective-ness. A rating of Optional indicates a specification thatdoes not affect how the analyzer performs its function,

but the presence of these options will provide widerapplications of use by offering greater testing optionsor minimizing user interaction, allowing the analyzerto be effectively operated under a wider variety ofcircumstances.

Choosing an analytic instrument will depend pri-marily on the assays available on an instrument, thethroughput capacity of the system, and the availabilityof models to meet different volume and testing needswithin the same hospital or health system. Referenceor central (main) laboratories will need larger, moreautomated instruments with a comprehensive testmenu and high throughput. Although analyzers usedin the main laboratory can also provide stat testing,they are most frequently used for determining diagno-sis, follow-up care, and the effectiveness of treatment.Midsize or small laboratories or those with specializedtesting requirements (i.e., emergency room, operatingroom, intensive care unit [ICU], neonatal intensivecare unit) can use smaller systems that may not be asautomated, have such a high throughput, or offer sucha broad test menu.

Laboratories that require specialty testing may con-sider smaller systems that offer the required test inthe shortest period of time using the smallest amountof patient specimen. Urgent or specialty testing labo-ratories might consider instruments that can assaywhole blood or samples that do not require centrifuga-tion. Analyzers used in specialty areas do not need asbroad a test menu as central analyzers; however, theyshould be capable of testing for certain key analytes,the presence or absence of which indicates a life-threatening situation and calls for immediate action.

Other considerations

ECRI recommends that hospitals evaluate the bloodgas analyzers they are considering for a few weeks intheir own clinical environment before purchase. On-site evaluation enables laboratories to verify the in-strument’s reported performance characteristics (e.g.,throughput, sensitivity, precision, accuracy, stability)with the workload and sample types that the labora-tory normally handles.

Final regulations of the Clinical Laboratory Im-provement Amendments of 1988 (CLIA) were publish-ed in February 1992 by the U.S. Department of Healthand Human Services (DHHS). Under CLIA regula-tions, all clinical laboratories are required to obtainfederally issued certificates. To acquire a certificate, alab must meet all relevant standards, which are deter-mined by the complexity of the tests being performed.Certification fees vary according to complexity leveland test volume. The standards set forth by CLIA



apply to areas such as patient test management, qual-ity control (QC), proficiency testing, personnel qualifi-cations, and quality assurance (QA) programs.Updates to the CLIA regulations have been made as ofJanuary 2003. The updates include new complexityclassifications and quality control requirements. Formore information about the updated regulations, seethe CLIA website at http://cms.gov/clia.

Before purchasing new equipment or upgrading ex-isting equipment, laboratories should thoroughly in-vestigate the CLIA regulations that apply to theirfacility and to the devices being considered. In certainsituations, purchasing or upgrading a device maychange the complexity category of the procedures. Thiscould require additional staff training and certifica-tion, as well as changes in QC, proficiency testing, QAprograms, and other laboratory procedures.

An effective QC system is an important cost contain-ment consideration. An inappropriate system can re-sult in unnecessary test runs, delayed patient results,and failure of proficiency tests, all of which waste timeand money. If the correct QC system is used, a largepercentage of such waste can be eliminated. In addi-tion to being cost-effective, a QC system must meetCLIA regulations.

An important consideration is the system’s com-puter interface capabilities. The system should be ableto interface with the existing LIS or the hospital’scentral computer system to input test data, verifytesting accuracy and calibration methods, and main-tain patient files according to the CLIA guidelines.Although CLIA does not mandate computerized re-porting systems in hospital laboratories, it does re-quire laboratories to have a system in place to ensurecompliance with CLIA performance standards for QCand QA of patient testing instruments and procedures.An effective LIS is helpful in managing the largevolume of test data a laboratory generates each day, aswell as a convenient and labor-saving method to com-ply with CLIA requirements.

Because of the risk of infection involved with han-dling any body-fluid specimen, purchasers should con-sider devices that minimize operator contact withspecimens. Some analyzers keep waste blood samplessealed in the reaction cartridges, which are removedand discarded after testing is complete.

Cost containment

When selecting a blood gas/pH analyzer, hospitalsshould consider who will be using and maintaining theinstrument, which analyzers are already being usedin the hospital, and what features are needed. For

example, the ability to generate a large number ofcalculated values is not an advantage if the values willnever be used. When they are used, clinicians must beaware that the parameter was derived and not actuallymeasured because inaccuracies may be present. Fur-thermore, if clinicians know the algorithm that wasused to obtain the derived value, they can better inter-pret and use the results. The following are perform-ance features that can be used to assess a unit’s overallusefulness as well as its long-term operating costs:

• Analytic range. The concentration range over whichan instrument can measure a particular analyte.

• Precision. A measure of how closely a test result canbe reproduced. Precision is expressed numericallyin terms of the coefficient of variation (CV), with asmall CV indicating a highly precise instrument.

• Stability. Analyzers that give readings with a highdegree of precision for extended periods of use havevery stable calibration curves and may be less costlyto operate than units with more labile curves.

• Carryover. Residue left over from a previous samplein a sample pathway or sample chamber. This resultsfrom incomplete flushing of the lines or chamber withthe rinse or wash solution. Carryover can cause erro-neously high or low readings in samples and result induplicate testing or even unit shutdown.

• Downtime. Downtime occurs when the analyzer isundergoing routine maintenance or is shut down fortroubleshooting and repairs. Some recently intro-duced analyzers require little or no maintenance,thereby eliminating this source of downtime.

• Timesaving features. Timesaving features may pro-vide labor reduction, improved sample throughput,and data management functions; many of thesefeatures, however, also add considerably to the op-erating costs of the instrument. Data managementsystems and disposable electrodes are examples ofsuch features.

• Upgrading/interfacing. Potential purchasersshould consider whether the analyzer can acceptfuture hardware upgrades. The cost of upgradingthe software annually should be included in anestimate of recurring expenses.

POC testing — laboratory testing done directly atthe bedside or in the same department/area where thepatient is located — is rapidly being implemented inhospitals throughout the United States, primarily be-cause of the demand for rapid test results. These de-vices are most frequently requested in the critical careunit, ICU, and emergency department. Most manufac-turers market their blood gas/pH analyzers as POCunits, regardless of their size and weight, because they



can be transported by cart to the bedside. Smaller unitsare available that are light enough to be carried to thetesting site by hand; one of them can be handheld andis battery powered. The major drawback to the smallerdevices is the high cost of consumables (e.g., some usea different disposable reaction cartridge with eachtest).

An effective system for blood gas analysis of patientsmay require more than just conventional blood gas/pHanalyzers. A combination of traditional analyzers,POC analyzers, and in vivo monitors is often the mostefficient method of patient blood gas analysis. Cur-rently, a major issue regarding implementation of newanalysis methods in the clinical laboratory is the cost-to-benefit ratio. It is generally felt that to justify adop-tion of new methods for performing laboratoryanalyses, a decrease in such a ratio is necessary. Inmany cases, the best way to reduce the ratio is bycombining traditional blood gas analysis with POCanalysis and in vivo monitoring. However, each health-care facility’s situation is different; therefore, hospitalsshould proceed cautiously when considering POC test-ing and perform their own cost-effectiveness studies ofthese devices, which could include the following:

• A cost-versus-charges analysis for tests performedon these units

• An estimation of the time and costs of labor neededfor user training and regular instrument operation

• The reimbursement status by major third-partypayers of tests performed on these devices

• An evaluation of the increased benefits from thesedevices (e.g., less operator contact with biohazar-dous materials, faster turnaround time)

For more information on POC analyzers, see theProduct Comparison titled POINT-OF-CARE ANALYZ-ERS, BLOOD GAS/PH; CHEMISTRY; ELECTROLYTES.

Because blood gas/pH analyzers entail ongoingmaintenance and operational costs, the initial acquisi-tion cost does not accurately reflect the total cost ofownership. Therefore, a purchase decision should bebased on issues such as life-cycle cost (LCC), localservice support, discount rates and non-price-relatedbenefits offered by the supplier, and standardizationwith existing equipment in the department or hospital(i.e., purchasing all analyzers from one supplier).

An LCC analysis can be used to compare high-costalternatives and/or to determine the positive or nega-tive economic value of a single alternative. For exam-ple, hospitals can use LCC analysis techniques toexamine the cost-effectiveness of leasing or rentingequipment versus purchasing the equipment outright.

Because it examines the cash-flow impact of initialacquisition costs and operating costs over a period oftime, LCC analysis is most useful for comparing alter-natives with different cash flows and for revealing thetotal costs of equipment ownership. One LCC tech-nique — present value (PV) analysis — is especiallyuseful because it accounts for inflation and for the timevalue of money (i.e., money received today is worthmore than money received at a later date). Conductinga PV/LCC analysis often demonstrates that the cost ofownership includes more than just the initial acquisi-tion cost and that a small increase in initial acquisitioncost may produce significant savings in long-term op-erating costs. The PV is calculated using the annualcash outflow, the dollar discount factor (the cost ofcapital), and the lifetime of the equipment (in years) ina mathematical equation.

When performing a PV/LCC analysis for bloodgas/pH analyzers, considerations include test menu,reagents/consumables, controls, and service contract.The following sample analysis is based on the purchaseof a blood gas/pH analyzer with a reagent contractagreement. Generally, suppliers will offer a discountedpurchase price if a reagent and/or service contract ispurchased with the system. The test menu of thesystem affects the analysis as well; the followinganalysis is based on a system with approximately fivemeasured and eight calculated parameters that willperform about 10 sample analyses per day. Also in-cluded in this analysis are the salary and benefits ofone full-time employee at $40,000/year. The purchaseof a co-oximeter to increase the accuracy of calculatedparameters could change the analysis considerably.Prices for various arrangements may also vary greatlydepending on facility size, number of units being pur-chased, and previous experience with the supplier.Individual suppliers should be contacted to find outwhat options are available for a specific facility.

The following represents a sample five-yearPV/LCC analysis for a blood gas/pH analyzer.

Present Value/Life-Cycle Cost Analysis (for outright pur-chase)

Assumptions

• Operating costs are considered for years 1 through 5

• Dollar discount factor is 5.57% for a 5-year treasury bill

• Inflation rate is 4% for support costs and disposables

Capital Costs

• System = $40,000

Total Capital Costs = $40,000



Operating Costs

• Service contract, years 2 through 5 = $4,600/year

• Salary and expenses for 1 full-time employee =$40,000/year

• Reagents = $10,950/year

Total Operating Costs = $50,950 for year 1;$55,550/year for years 2 through 5

PV = ($315,072)

Other costs not included in the above analysis thatshould be considered for budgetary planning includethose associated with the following:

• Software upgrades not included under warranty orin the service contract

• Utilities

• Contributions to overhead

As illustrated by the above sample PV/LCC analy-sis, the initial acquisition cost is only a fraction of thetotal cost of operation over five years. Therefore, ratherthan making a purchase decision based solely on theacquisition cost of a blood gas/pH analyzer, buyersshould consider operating costs over the lifetime of theequipment.

For further information on PV/LCC analysis, cus-tomized analyses, and purchase decision support,readers should contact ECRI’s SELECT™ Group.

Hospitals can purchase service contracts or serviceon a time-and-materials basis from the supplier. Serv-ice may also be available from a third-party organiza-tion. The decision to purchase a service contract shouldbe carefully considered. Most suppliers provide routinesoftware updates, which enhance the system’s per-formance, at no charge to service contract customers.Furthermore, software updates are often cumulative;that is, previous software revisions may be required inorder to install and operate a new performance feature.Purchasing a service contract also ensures that pre-ventive maintenance will be performed at regular in-tervals, thereby eliminating the possibility ofunexpected maintenance costs. Also, many suppliersdo not extend system performance and uptime guaran-tees beyond the length of the warranty unless thesystem is covered by a service contract.

ECRI recommends that, to maximize bargainingleverage, hospitals negotiate pricing for service con-tracts before the system is purchased. Additional serv-ice contract discounts may be negotiable formultiple-year agreements or for service contracts thatare bundled with contracts on other analyzers in thedepartment or hospital.

Buyers should also negotiate for a nonobsolescenceclause stating that the supplier agrees not to introducea replacement system within the next one or two yearsand that if a replacement system is introduced duringthis time period, 100% of the purchase price can beapplied to the purchase of the new system.

In addition, given the current highly competitivemarket for clinical laboratory equipment, hospitalsshould negotiate for a significant discount — somesuppliers may discount up to 20% or 30%. The actualdiscount received will depend on the hospital’s negoti-ating skills, the system configuration and model to bepurchased, the number of units being purchased, pre-vious experience with the supplier, and the extent ofconcessions granted by the supplier, such as extendedwarranties, fixed prices for annual service contracts,and guaranteed on-site service response. Buyersshould make sure that application training is includedin the purchase price of the system. Some suppliers dooffer more extensive on-site or off-site training pro-grams for an additional cost.

Also, if multiple analyzers are necessary to handlethe patient volume, hospitals should consider the typesof systems and capabilities that need to be purchasedto avoid paying for unnecessary analysis packages.Standardization of equipment can make staff trainingeasier, simplify servicing and parts acquisition, andprovide greater bargaining leverage when negotiatingnew equipment purchases and/or service-contractcosts.

The terms on which a facility acquires a bloodgas/pH analyzer can greatly influence overall lifetimecosts. There are three primary types of acquisition:outright purchase, lease, or reagent rental.

An outright purchase of a system is when the facilitybuys the equipment along with the ownership rights.When leasing a system, the facility pays a set amountper month for the use of the instrument and canexercise one of several options at the end of the contractperiod, such as a fair market buyout or return of thesystem to the manufacturer. The two main types ofleases are capital leases, which are for the equipmentonly, and operational leases, which include the servicecosts and occasionally the reagent/consumables costs.

Reagent rental agreements allow a facility to ac-quire a system by purchasing the reagents. Reagentpricing is generally divided into three categories: asneeded, cost per test (CPT), and cost per reportable test(CPRT), also called cost per billable test or cost perreportable result (CPRR). The CPT option takes intoaccount all the tests that must be run on the instru-ment, including patient tests, QC tests, and any test



reruns. The CPRT option only considers those teststhat are reported in the patient’s chart and for whichthe hospital can be reimbursed; this results in a higherCPT because the cost for nonreportable tests is ab-sorbed by the manufacturer but passed along in thereportable-test cost. The as-needed reagent rental op-tion is one that is typically not used for blood gas/pHanalyzers because they require so many reagents.

Reagent pricing includes the cost of the instrumentand, usually, service. There are a number of factorsthat influence reagent pricing no matter how the sys-tem is acquired:

• Hospital test volume

• Duration of the reagent contract (e.g., 36, 48, 60, or72 months)

• Type of service provided (24 hours/day, 7 days/week;Monday through Friday, 8 a.m. to 5 p.m.; or preven-tive maintenance only)

• Whether service will be purchased for the durationof the contract or purchased separately

• Whether service will be purchased at the point ofsale for the term of the agreement (e.g., five years)

• Whether the reagent prices will remain unchangedfor the duration of the contract or whether there isan inflationary increase after a period of time (e.g.,level for years one through three, with percent in-creases in remaining contract years)

• Whether there is a cap on inflationary increases andhow much (typically the consumer price index, butsometimes as high as 5%)

• Whether the facility has other instrumentation fromthe same manufacturer in other hospital depart-ments (supplier presence)

Although reagents from alternative suppliers can beused on some blood gas analyzers, the analyzers’manufacturers do not recommend this because theyclaim it presents a high risk of electrode damage. Usingalternative reagents can void the instrument’s war-ranty, depending on the warranty conditions, the typeof repair needed, and the supplier’s policy.

Hospitals should negotiate the best price for consu-mables (e.g., reagents, calibration gases and controls)and service contracts at the time of purchase. Thehospital should also retain the option to accept or rejectthe service contract at the end of the warranty period.

Current analyzer users are valuable sources of in-formation on the quality, reliability, and overall effi-ciency of the instruments. Buyers should ask analyzermanufacturers to supply an unedited list of their cus-tomers when considering an instrument.

Stage of developmentFew modifications have been made to the principles

of measurement used by blood gas/pH analyzers thatuse externally drawn blood; however, the increaseduse of microprocessors has enhanced data reduction,decreased reporting time, and automated calibration.Today’s blood gas analyzers use small samples andcalculate many other blood gas parameters in additionto pH, PO2, and PCO2. Several units also measureelectrolytes, hemoglobin or hematocrit, and other me-tabolites such as glucose and calcium. Calibration fre-quency can be programmed, and self-diagnosticmessages assist in troubleshooting. Several modelsinclude onboard data management systems that storepatient data and display accumulated QC results.Manual refurbishment of electrodes has been simpli-fied in some cases with the use of premembranedelectrode caps or cartridges and maintenance-free elec-trodes. Microcircuit technology has enabled manufac-turers to miniaturize electrodes, thereby reducing theoverall size of the analyzer. Current analyzers can alsobe interfaced to electrolyte analyzers, co-oximeters, orhospital computer systems. POC devices continue toget smaller with increased capabilities.

Bibliography

Burtis CA, Ashwood ER, eds. Tietz fundamentals ofclinical chemistry. 5th ed. Philadelphia: WB Saun-ders; 2000.

Felder RA. Robotics and automated workstations forrapid response testing. Am J Clin Pathol 1995Oct;104(4 Suppl 1):S26-31.

Henry JB, ed. Clinical diagnosis and management bylaboratory methods. 18th ed. Philadelphia: WBSaunders; 1991.

Maas AH, Weisberg HF, Zijlstra WG, et al. Referencefor pH measurement in blood. J Clin Chem ClinBiochem 1983 May;21(5):313-21.

Mahoney JJ, Harvey JA, Wong RJ, et al. Changes inoxygen measurements when whole blood is storedin iced plastic or glass syringes. Clin Chem 1991Jul;37(7):1244-8.

Moran RF. Blood gases and other critical care ana-lytes. Clinical Laboratory News 2000 Aug:12-14.

Pesce AJ, Kaplan LA. Methods in clinical chemistry.St. Louis: CV Mosby; 1987.

Schoeff LE, Williams RH, eds. Principles of laboratoryinstruments. St. Louis: Mosby; 1993.



Shapiro BA. Clinical and economic performance crite-ria for intraarterial and extraarterial blood gasmonitors, with comparison with in vitro testing. AmJ Clin Pathol 1995 Oct;104(4 Suppl 1):S100-6.

Shirey TL. Critical care profiling for informed treat-ment of severely ill patients. Am J Clin Pathol 1995Oct;104(4 Suppl 1):S79-87.

Toffaletti J. Special Topics in Diagnostic Testing:Blood Gases and Electrolytes Washington DC:AACC Press; 2001.

Tsai WW, Nash DB, Last JV. Point-of-care testing:barriers and facilitators to implementation. AmClin Lab 1994 Oct;13(10):14.

U.S. Department of Health and Human Services.Health Care Financing Administration. ClinicalLaboratory Improvement Amendments of 1988(CLIA). Fed Regist 1992 Feb 28;57(40):7002-288.

Standards and guidelines

Note: Although every effort is made to ensure that thefollowing list is comprehensive, please note that otherapplicable standards may exist.

American Association for Respiratory Care. Blood gasanalysis and hemoximetry [guideline]. Respir Care2001 May 46(5):498-505.

Capillary blood gas sampling for neonatal and pedi-atric patients [guideline]. Respir Care 1994Dec;39(12):1180-3.

American National Standards Institute/Associationfor the Advancement of Medical Instrumentation.Safe current limits for electromedical apparatus[standard]. 3rd ed. ANSI/AAMI ES1-1993. 1985 (re-vised 1993).

International Electrotechnical Commission. Medicalelectrical equipment — part 1: general require-ments for safety [standard]. IEC 60601-1-1 (1988-12). 1988 (revised 2000).

Medical electrical equipment — part 1: general re-quirements for safety. Amendment 1 [standard].IEC 60601-1-am1 (1991-11). 1991.

Medical electrical equipment — part 1: general re-quirements for safety. Amendment 2 [standard].IEC 60601-1-am2 (1995-03). 1995.

Medical electrical equipment — part 1: general re-quirements for safety. Section 1. Collateral standard:safety requirements for medical electrical systems.Amendment 1. IEC 60601-1-1-am1 (1995-11). 1995.

Medical electrical equipment — part 1: general re-quirements for safety. Section 2. Collateral standard:electromagnetic compatibility — requirements andtests. IEC 60601-1-2 (2002-04). 2002.

Medical electrical equipment — part 1-1: generalrequirements for safety. Collateral standard: safetyrequirements for medical electrical systems. 2nd ed.IEC 60601-1-1 (2000-12). 1992 (revised 2000).

International Federation of Clinical Chemistry andLaboratory Medicine. IFCC reference measurementprocedure for substance concentration of total carb-on dioxide in blood, plasma or serum [guideline].Clin Chem Lab Med 2001 Mar 39(3):283-9.

NCCLS — The Clinical Laboratory Standards Organi-zation. Body fluid and tissue specimen collection:NCCLS specialty collection [guideline]. SC18-L.2001.

Blood gas and pH analysis and related measure-ments [guideline]. C46-A. 2001.

Standardization of sodium and potassium ion-selec-tive electrode systems to the flame photometric ref-erence method. C29-A2. 1989 (revised 2000).

Citations from other ECRI publications

Health Devices

Blood gas/pH analyzers [evaluation]. 1995 May-Jun;24(5-6):208-43.

Health Devices Alerts

This Product Comparison lists Health Devices Alerts(HDA) citations published since the last update of thisreport. Each HDA abstract is identified by an Acces-sion Number. Recalls and hazard reports include de-scriptions of the problem involved; abstracts of otherpublished articles are referenced by bibliographic in-formation. HPCS subscribers can call the Hotline foradditional information on any of these citations or torequest more extensive searches of the HDA database.

D6223 FDA has designated Class II Recall Nos. Z-0845/0846-03 complete for certain InstrumentariumLaboratory Co. GEM Premier 3000 BG/HCT car-tridges. An incorrect bar code was applied to the abovecartridges, potentially resulting in incorrect PO2 val-ues. The manufacturer initiated a recall by letter andtelephone call on March 7, 2003. The firm states thatno affected product remains on the market. No furtheraction is required of customers. Source: FDA Enforce-ment Rep 2003 Jun 4; Manufacturer.



40433 Ganter M, Zollinger A. Continuous intravascu-lar blood gas monitoring: development, current tech-niques, and clinical use of a commercial device. Br JAnaesth 2003 Sep;91(3):397-407.

40711 Menzel M, Soukup J, Henze D, et al. Experi-ences with continuous intra-arterial blood gas moni-toring: precision and drift of a pure optode-system.Intensive Care Med 2003 Dec;29(12):2180-6.

Supplier information

Bayer

Bayer Diagnostics GmbH [284586]Weissenseestrasse 101D-81539 MuenchenGermanyPhone: 49 (89) 69927293Fax: 49 (89) 69927290Internet: http://www.bayer.de

Bayer HealthCare (Canada)Diagnostics Div [428440]77 Belfield RdToronto ON M9W 1G6CanadaPhone: (416) 248-0771, (800) 268-7200Fax: (416) 248-5373Internet: http://www.bayerhealth.ca

Bayer HealthCare (US)Diagnostics Div [223454]511 Benedict AveTarrytown NY 10591-5097Phone: (914) 631-8000, (800) 255-3232Fax: (914) 524-2132Internet: http://www.bayerdiag.com

Bayer HealthCare LtdDiagnostic Div [435483]Colchester RoadHalstead, Essex CO9 2DXEnglandPhone: 44 (1635) 563000Fax: 44 (1787) 475088E-mail: [email protected]: http://www.bayer.co.uk

Eschweiler

Eschweiler GmbH & Co KG [152065]Holzkoppelweg 35D-24118 Kiel 1GermanyPhone: 49 (431) 546580Fax: 49 (431) 549423E-mail: [email protected]: http://www.eschweiler-kiel.de

Instrumentation Laboratory

Instrumentation Laboratory (Hong Kong)[398965]29/Fl Wing On Centre111 Connaught Road CentralHong KongHong Kong SARPeople’s Republic of ChinaPhone: 852 27927773Fax: 852 27919972E-mail: [email protected]: http://www.ilww.com

Instrumentation Laboratory Co [101922]101 Hartwell AveLexington MA 02421-3125Phone: (781) 861-0710, (800) 955-9525Fax: (781) 861-1908E-mail: [email protected]: http://www.ilus.com

Instrumentation Laboratory GmbH [283451]Klausnerring 4D-85551 Kichheim bei MuenchenGermanyPhone: 49 (89) 907070Fax: 49 (89) 90907116E-mail: [email protected]: http://www.ilww.com

i-STAT

i-STAT Corp [152626]104 Windsor Center DrEast Windsor NJ 08520-1407Phone: (609) 443-9300, (800) 827-7828Fax: (609) 443-9310E-mail: [email protected]: http://www.i-stat.com

ITC

ITC Europe [401520]strada RivoltanaI-20090 Rodano MIItalyPhone: 39 (02) 95320196Fax: 39 (02) 95320276E-mail: [email protected]: http://www.itcmed.com



Jokoh

Jokoh Co Ltd [156132]19-4 Hongo 3-chomeBunkyo-kuTokyo 113JapanPhone: 81 (3) 38151717Fax: 81 (3) 38151759E-mail: [email protected]: http://www.jokoh.com

Medica

Medica Corp [105300]5 Oak Park DrBedford MA 01730-1413Phone: (781) 275-4892, (800) 777-5983Fax: (781) 275-2731E-mail: [email protected]: http://www.medicacorp.com

Metracor

Metracor Technologies Inc [402523]11425 Sorrento Valley RdSan Diego CA 92121-1343Phone: (858) 793-3300, (800) 385-9697Fax: (858) 793-3315E-mail: [email protected]: http://www.metracor.com

Nova

Nova Biomedical Canada Ltd [323708]6810 Kitimat Rd Unit 5Mississauga ON L5N 5M2CanadaPhone: (905) 567-7700, (800) 263-5999Fax: (905) 567-5496E-mail: [email protected]: http://www.novabiomedical.com

Nova Biomedical Corp [102723]200 Prospect StWaltham MA 02454-9141Phone: (781) 894-0800, (800) 458-5813Fax: (781) 894-5915E-mail: [email protected]: http://www.novabiomedical.com

Nova Biomedical GmbH [285869]Adam-Opel-Strasse 19a S/SED-63322 RoedermarkGermanyPhone: 49 (6074) 84480Fax: 49 (6074) 844833E-mail: [email protected]: http://www.novabiomedical.com

Nova Biomedical KK [323711]Avenue Takanawa 4053-25-27 Takanawa Minato-kuTokyo 108JapanPhone: 81 (3) 34739641Fax: 81 (3) 57917012Internet: http://www.novabiomedical.com

Radiometer

Radiometer A/S [139324]Akandevej 21DK-2700 BronshojDenmarkPhone: 45 38273827Fax: 45 38272727E-mail: [email protected]: http://www.radiometerdanmark.dk

Radiometer America Inc [101928]810 Sharon DrWestlake OH 44145Phone: (440) 871-8900, (800) 736-0600Fax: (440) 871-0309E-mail: [email protected]: http://www.radiometeramerica.com

Radiometer GmbH [287436]Linsellesstrasse 142D-47877 WillichGermanyPhone: 49 (2154) 8180Fax: 49 (2154) 818184E-mail: [email protected]: http://www.radiometer.de

Radiometer Pacific Pty Ltd (Australia) [256369]PO Box 47Nunawading, VIC 2084AustraliaPhone: 61 (3) 92592222Fax: 61 (3) 98948362E-mail: [email protected]: http://www.radiometer.com.au

Roche Diagnostics

Roche Diagnostics (Canada) [351509]201 boul Armand-FrappierLaval PQ H7V 4A2CanadaPhone: (450) 686-7050, (800) 361-2070Fax: (450) 686-7009E-mail: [email protected]: http://www.rochediagnostics.ca



Roche Diagnostics (Deutschland) GmbH [401592]Sandhoferstrasse 116D-68305 MannheimGermanyPhone: 49 (621) 7590Fax: 49 (621) 7592890Internet: http://www.roche.de/diagnostics

Roche Diagnostics (Hong Kong) Ltd [401585]Unit 3206-3214 Level 32 Metroplaza Tower 1223 Hing Gong Road Kwai ChungNew TerritoriesHong Kong SARPeople’s Republic of ChinaPhone: 852 24813387Fax: 852 24180728Internet: http://www.roche.com/diagnostics

Roche Diagnostics Corp [391899]9115 Hague RdPO Box 50457Indianapolis IN 46256Phone: (317) 521-2000, (800) 428-5074Fax: (317) 521-4696Internet: http://www.roche-diagnostics.us

Techno Medica

Techno Medica KK [182832]1215-1 Mizono-kuchiTakatsu-kuKawasaki-shi, Kanagawa Pref 213JapanPhone: 81 (46) 9481961Fax: 81 (46) 9481962

About the chart specificationsThe following terms are used in the chart:

Analysis time, sec: The time from sample insertion to adisplayed or printed result.

Calibration: Initiated by the instrument at prepro-grammed intervals. The operator can initiate randomcalibrations and calibrations during standby mode.

Standby mode: Unit calibrates only when the operatoris ready to analyze the specimen. (If the unit is notin standby mode, it will calibrate according to pro-grammed intervals.)

Abbreviations:

a/A — The ratio of the partial pressures of O2 inarterial blood and alveolar air

A-aDO2 — The alveolar-arterial O2 tension gradient

AG — The anion gap, which is obtained by subtract-ing the chloride and bicarbonate from the sodiumconcentration

APTT — Activated partial thromboplastin time

ASTM — American Society for Testing and Materials

BB — Buffer base, the total equivalent concentra-tion of all the anionic buffering components of theblood (i.e., hemoglobin, bicarbonate, plasma pro-teins, phosphates, sulfates)

BE — Base excess, also called actual base excess(ABE) or base excess blood (BEB); the amount ofacid or base needed to titrate the blood to a pH of7.4 at a PCO2 of 40 mm Hg at 37°C (in vitro)

BEecf — Base excess, extracellular fluid — alsocalled the standard base excess (SBE) — the invivo base excess that depends on the blood andthe equilibration of the interstitial or extracellu-lar fluid compartments of the body; it is generallyaccepted that it reflects the metabolic (not respi-ratory) aspect of blood pH disturbances

BP — Barometric pressure of the room; measuredfor calibration purposes

BUN — Blood urea nitrogen

Ca++ — Calcium ion concentration

CaO2, CcO2, CvO2 — The arterial, capillary, andmixed venous total O2 content of blood, respectively

CE — Communaute Europeen

CE mark — Conformite Europeene mark

cH+ — The concentration of hydrogen ions (H+) inthe plasma

cH+(T) — The H+ concentration in the plasma at thepatient’s body temperature

Cl- — Chloride ion concentration

COHb — Carboxyhemoglobin

CSA — Canadian Standards Association

ctCO2 — The concentration of total CO2 (free andbound) in the plasma; calculated as the sum ofbicarbonate and carbonic acid

ctO2 (or O2 Ct) — Oxygen content, a calculatedvalue that reflects the total O2 concentration in agiven volume of blood, present as both dissolvedO2 and oxyhemoglobin (HbO2 or O2Hb)

DOB — Date of birth



EMC — Electromagnetic compatibility

EMV — Eye, motor, voice

EQC — Electronic quality control

ETL — ETL Testing Laboratories

FDA — U.S. Food and Drug Administration

FHb — Fetal hemoglobin

FiO2 — The fraction of O2 inspired by the lungs thatis absorbed into arterial blood

Hb — Hemoglobin

HCO3- — The concentration of hydrogen carbonate

(bicarbonate) in the plasma

Hct — Hematocrit

HIS — Hospital information system

HL7 — Health Level 7

IEC — International Electrotechnical Commission

INR — International Normalized Ratio

ISO — International Organization for Standardiza-tion

JIS — Japanese Industrial Standard

K+ — Potassium ion concentration

LCD — Liquid crystal display

Li+ — Lithium ion concentration

LIS — Laboratory information system

MDD — Medical Devices Directive

MetHb — Methemoglobin

Mg++ — Magnesium ion concentration

Na+ — Sodium ion concentration

OVE — Osterreichischer Verband fuer Electrotech-nik

P50 (or P50) — The value of PO2 for a given sample inwhich the hemoglobin is 50% saturated with O2

PaO2/PAO2 — Ratio of arterial O2 tension to alveo-lar O2 tension

PCO2 Ct — CO2 content, a calculated value thatreflects the total CO2 concentration in a givenvolume of blood, present as dissolved CO2, asbicarbonate ion (HCO3

-), and bound to hemoglo-bin (carbaminohemoglobin)

PCO2(T) — The partial pressure of CO2 in blood atthe patient’s body temperature

PEEP — Positive end-expiratory pressure

pH — The measurement of the acidity of plasma;the acidity is related to the H+ concentration

pH(T) — The acidity of plasma at the patient’s bodytemperature

PO2(T) — The partial pressure of O2 in blood at thepatient’s body temperature

POC — Point of care

QC — Quality control

Qsp/Qt — The ratio of shunt flow to total flow; alsocalled the physiological shunt

RHb — Deoxyhemoglobin or reduced hemoglobin;also expressed as HHb

RI — Respiratory index

RQ — Respiratory quotient; ratio of the rates of CO2

production and O2 consumption in the body

SB (or SBC) — Standard bicarbonate, the concentra-tion of bicarbonate in plasma at a PCO2 of 40 mmHg, a PO2 of 100 mm Hg, and a temperature of37°C

SBE — Standard base excess

SI units — Systeme International d’Unites (Interna-tional System of Units)

SO2 (or sO2%, SAT) — Functional O2 saturation; anestimated percentage value indicating theamount of fully oxygenated hemoglobin (oxy-hemoglobin) divided by the hemoglobin that canbe bound (i.e., the functional hemoglobins — oxy-hemoglobin + deoxyhemoglobin); it can be calcu-lated by an oximeter: SO2 = [O2Hb/(O2Hb + HHb)]× 100%

Std pH — Standard pH, also called the eucapnic pH;the pH of the blood when the PCO2 is 40 mm Hg

TCO2 — Total CO2

TCP/IP — Transmission Control Protocol/InternetProtocol

TFT — Thin film transistor

tHb — The sum of all hemoglobin derivatives, includ-ing oxyhemoglobin, deoxyhemoglobin, carboxy-hemoglobin, methemoglobin, and sulfhemoglobin

TUV — Technischer Ueberwachungs Verein



UL — Underwriters Laboratories

UPS — Uninterruptible power supply

VAC — Volts of alternating pressure

VGA — Video Graphics Array

Note: The data in the charts derive from suppli-ers’ specifications and have not been verified throughindependent testing by ECRI or any other agency.Because test methods vary, different products’ specifi-cations are not always comparable. Moreover, productsand specifications are subject to frequent changes.ECRI is not responsible for the quality or validity ofthe information presented or for any adverse conse-quences of acting on such information.

When reading the charts, keep in mind that, unlessotherwise noted, the list price does not reflect supplierdiscounts. And although we try to indicate whichfeatures and characteristics are standard and whichare not, some may be optional, at additional cost.

For those models whose prices were supplied to usin currencies other than U.S. dollars, we have alsolisted the conversion to U.S. dollars to facilitate com-parison among models. However, keep in mind thatexchange rates change often.

Need to know more?For further information about the contents of this

Product Comparison, contact the HPCS Hotline at +1(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); [email protected] (e-mail).

About ECRI . . .ECRI is a nonprofit health services research agency and a Collaborating Center of the World HealthOrganization, providing information and technical assistance to the healthcare community to supportsafe and cost-effective patient care for more than 25 years. The results of ECRI’s research andexperience are available through its publications, information systems, databases, technical assis-tance program, laboratory services, seminars, and fellowships.

Our full-time staff includes a wide range of specialists in healthcare technology, hospital admini-stration, financial analysis, risk management, and information and computer science, as well ashospital planners, attorneys, physicists; biomedical, electrical, electronic, chemical, mechanical, andregistered engineers; physicians; basic medical scientists; epidemiologists and biostatisticians; andwriters, editors, and communications specialists.

Underlying ECRI’s knowledge base in healthcare technology are its integrity and objectivity. ECRIaccepts no financial support from medical product manufacturers, and no employee may own stockin or consult for a medical equipment or pharmaceutical company.

The scope of ECRI’s resources extends far beyond technology. ECRI keeps healthcare professionals,manufacturers, legal professionals, information specialists, and others aware of the changing trendsin healthcare, healthcare standards and regulations, and the best ways to handle environmental andoccupational health and safety issues. ECRI also advises on management issues related to healthcarecost containment, accreditation, risk management, human resources, quality of care, and othercomplex topics.

ECRI has more than 35 publications, databases, software, and services to fulfill the growing needfor healthcare information and decision support. They focus on three primary areas: healthcaretechnology, healthcare risk and quality management, and healthcare environmental management.



Product Comparison Chart

MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED BAYER BAYERSPECIFICATIONS * SPECIFICATIONS *Central/Main Unit Stat/Specialty Unit Rapidlab 248 Rapidlab 348

WHERE MARKETED Worldwide Worldwide

FDA CLEARANCE Yes Yes

CE MARK (MDD) Yes Yes

TESTS AVAILABLEMeasured (range)

BP, mm Hg Preferred Optional 400-825 400-825Ca++, mmol/L Preferred Optional No 0.2-5.0Hct, % Preferred Optional No 12-75K+, mmol/L Preferred Optional No 0.50-9.99Na+, mmol/L Preferred Optional No 80-200pH Required Required 6.500-8.000 6.001-8.000PCO2, mm Hg Required Required 5-250 5-250PO2, mm Hg Required Required 0-749 0-749

Others None Cl-

Deriveda/A Preferred Optional Yes YesA-aDO2 Preferred Optional Yes YesBE Preferred Optional Yes YesBEecf Preferred Optional Yes YesHb Preferred Optional No YesHCO3

- Preferred Optional Yes YesctO2 Preferred Optional Yes YesSB Preferred Optional No NoSO2 Preferred Optional Yes YesctCO2 Preferred Optional Yes YesOthers No No

SO2 & ctO2 ON/OFF No No

SAMPLE VOLUME, µLNormal Required Optional 85 95

Micro Preferred Required 35 40

INTEGRAL MULTI-WAVELENGTH OXIMETER Optional Optional No No

VISIBLE SAMPLECHAMBER Yes Yes

ANALYSIS TIME, sec 45 50

ELECTRODEMAINTENANCE Minimal None required None None

DISPLAY Fluorescent Fluorescent

PRINTOUT Optional Preferred Roll printer Roll printer

Colons separate data on similar models of a device. This is the first of* These specifications are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on two pages covering

this data. the above model(s).These specificationscontinue onto thenext page.




MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED BAYER BAYERSPECIFICATIONS * SPECIFICATIONS *Central/Main Unit Stat/Specialty Unit Rapidlab 248 Rapidlab 348

CALIBRATION Automatic, preferred Automatic, required Automatic, Automatic,programmable programmable

STANDBY MODE Yes Yes

INTERFACE Required Preferred RS232 RS232

DATA MANAGEMENT Required Preferred Last QC and sample, Last QC and sample,optional external optional externaldata manager with data manager withRapidlink Rapidlink

USER-ENTERED DATA Required Required Patient temp, FiO2, Patient temp, FiO2,patient/operator ID, patient/operator ID,tHb tHb

BAR-CODE READER Preferred Preferred No No

PASSWORD PROTECTION See Other Specs See Other Specs Yes (for setup) Yes (for setup)

POWER REQUIREMENTS,VAC, Hz 100/120/220/240, 100/120/220/240,

50/60 50/60

POWER CONSUMPTION 80 VA 80 VA

H x W x D, cm (in) 38.1 x 38.1 x 33 38.6 x 38 x 37.1(15 x 15 x 13) (15.3 x 15 x 14.6)

WEIGHT, kg (lb) 9.1 (20) 13.1 (28.8)

LIST PRICE $19,500 $26,200

Warranty 1 year 1 year

OTHER SPECIFICATIONS May require gas Should not require Yes/no prompts for Yes/no prompts fortank; should provide gas tank; should easy operation; easy operation;unauthorized access provide unauthorized interfaces w/printer interfaces w/printerlockout. access lockout. and data management and data management

system. system.Meets requirements Meets requirementsof CE, CSA, and UL. of CE, CSA, and UL.

Colons separate data on similar models of a device.* These specifications are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on

this data.




MODEL BAYER BAYER BAYER BAYER

Rapidlab 840 * Rapidlab 850 * Rapidlab 860 * Rapidpoint 400 :Rapidpoint 405 *

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes

CE MARK (MDD) Yes Yes Yes Yes


BP, mm Hg 400-825 400-825 400-825 523-800Ca++, mmol/L Available w/upgrade Available w/upgrade Yes 0.2-5Hct, % No No No 12-75K+, mmol/L Available w/upgrade Available w/upgrade Yes 0.5-15.0Na+, mmol/L Available w/upgrade Available w/upgrade Yes 100-200pH 6.500-8.000 6.500-8.000 6.500-8.000 6.500-8.000PCO2, mm Hg 5-250 5-250 5-250 10-150PO2, mm Hg 0-800 0-800 0-800 10-700

Others Optional Cl-, others Cl-, glucose, Cl-, glucoseavailable w/upgrade lactate

Deriveda/A Yes Yes Yes YesA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf No Yes Yes YesHb No Available w/upgrade No No : YesHCO3

- Yes Yes Yes YesctO2 Yes Yes Yes No : YesSB No No No NoSO2 Yes Yes Yes YesctCO2 Yes Yes Yes YesOthers No No a-v,+a-v/a a-v, a-v/a

SO2 & ctO2 ON/OFF Available w/upgrade Available w/upgrade Available w/upgrade Available w/upgrade

SAMPLE VOLUME, µLNormal 90 130 125 100-130

Micro 55 70 95 75

INTEGRAL MULTI-WAVELENGTH OXIMETER Available w/upgrade Available w/upgrade Available w/upgrade Available w/upgrade

VISIBLE SAMPLECHAMBER Yes Yes Yes No

ANALYSIS TIME, sec 60 100 100 60

ELECTRODEMAINTENANCE None None None None

DISPLAY Color LCD Color LCD LCD Color touchscreen

PRINTOUT Roll printer, Roll printer, Roll printer, Roll printeroptional ticket or optional ticket or optional ticket orline printer line printer line printer

Colons separate data on similar models of a device. This is the first of* Models 400, 840, 850, and 860 are upgradable to Models 405, 845, 855, and 865, respectively. Upgrade includes an integral two pages covering

co-oximeter module. For more specific details on additional parameters with the the upgrade, contact the manufacturer. the above model(s).These specificationscontinue onto thenext page.




MODEL BAYER BAYER BAYER BAYER

Rapidlab 840 * Rapidlab 850 * Rapidlab 860 * Rapidpoint 400 :Rapidpoint 405 *

CALIBRATION Automatic, Automatic, Fixed and flexible, Fixed (30 min,programmable programmable programmable 1-point; 120 min,

2-point)

STANDBY MODE Yes Yes Yes No

INTERFACE RS232 (3), RS232 (3), RS232 (3), RS232, TCP-IP1 parallel, TCP/IP 1 parallel, TCP/IP 1 parallel, TCP/IPconverter converter converter

DATA MANAGEMENT 5,000 patient rec- 5,000 patient rec- 5,000 patient rec- 250 patients,ords, patient demo- ords, patient demo- ords, patient demo- 250 cal, 250 events,graphics, 12 x 150 graphics, 12 x 150 graphics, 12 x 150 250 QCQC storage, Levey- QC storage, Levey- QC storage, Levey-Jennings plots ** Jennings plots ** Jennings plots **

USER-ENTERED DATA Patient temp, FiO2, Patient temp, FiO2, Patient temp, FiO2, Patient temp, FiO2,tHb, oxygen flow, tHb, oxygen flow, tHb, oxygen flow, tHb, oxygen flow,patient/operator ID, patient/operator ID, patient/operator ID, patient/operator ID,sample source, sample source, sample source, sample source,date/time date/time date/time date/time

BAR-CODE READER Optional Optional Optional Optional

PASSWORD PROTECTION 4 domains 4 domains Yes Yes

POWER REQUIREMENTS,VAC, Hz 100/120/220/240, 100/120/220/240, 100/120/220/240, 100/120/220/240,

50/60 50/60 50/60 50/60

POWER CONSUMPTION 250 VA 250 VA 400 VA 150 VA

H x W x D, cm (in) 50.8 x 55.9 x 48.3 50.8 x 55.9 x 48.3 50.8 x 55.9 x 48.3 21.5 x 15.5 x 16(20 x 22 x 19) (20 x 22 x 19) (20 x 22 x 19) (8.5 x 6.1 x 6.3)

WEIGHT, kg (lb) 29.5 (65) 29.5 (65) 29.5 (65) 34 (75) : 44 (97)

LIST PRICE $28,000 (840), $36,000 (850), $40,000 (860), $38,000 : $44,000$37,900 (845) $45,900 (855) $49,900 (865)

Warranty 1 year 1 year 1 year 1 year

OTHER SPECIFICATIONS Onboard reagent- Onboard reagent- Onboard reagent- Multiuse cartridges;level indication, level indication, level indication, 6 types of cart-automatic cleaning automatic cleaning automatic cleaning ridges (3 menus,cycle; actual and cycle; actual and cycle; actual and 2 sizes); interfaceestimated shunt; estimated shunt; estimated shunt; with data manage-500 operator pass- 500 operator pass- 500 operator pass- ment; multimediawords; keyboard; words; keyboard; words; keyboard; user interface withexternal data man- external data man- external data man- commented videos andagement system; bar- agement system; bar- agement system; bar- intuitive icons; 500code reader and code reader and code reader and users on 4 securityintegrated co-oxi- integrated co-oxi- integrated co-oxi- levels; optionalmeter are optional. meter are optional. meter are optional. automatic, mainten-Meets requirements Meets requirements Meets requirements ance-free QC module.of CE, CSA, and UL. of CE, CSA, and UL. of CE, CSA, and UL. Meets requirements

of CE, CSA, and UL.

Colons separate data on similar models of a device.* Models 400, 840, 850, and 860 are upgradable to Models 405, 845, 855, and 865, respectively. Upgrade includes an integral

co-oximeter module. For more specific details on additional parameters with the the upgrade, contact the manufacturer.** Also features a maintenance log.




MODEL ESCHWEILER ESCHWEILER ESCHWEILER ESCHWEILER

COMBISYS II COMBISYS II ECOSYS II MODULARBGA Plus E BGA plus E and tHb


FDA CLEARANCE Not specified Not specified Not specified Not specified



BP, mm Hg 500-900 500-900 500-900 500-900Ca++, mmol/L 0.25-2.5 0.25-2.5 No 0.25-2.5Hct, % No Derived from Hb No Derived from HbK+, mmol/L 2-10 2-10 No 2-10Na+, mmol/L 100-200 100-200 No 100-200pH 6.000-8.000 6.000-8.000 6.000-8.000 6.000-8.000PCO2, mm Hg 10-200 10-200 10-200 50-200PO2, mm Hg 0-800 0-800 0-800 50-800

Others Cl-, Li+, temp Cl-, Li+, temp, tHb Temp tHb, Cl-, Li-,glucose, lactate,temp

Deriveda/A No No No NoA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf No No No NoHb Measured Measured No MeasuredHCO3

- Actual and standard Actual and standard Actual and standard Actual and standardctO2 Yes Yes Yes YesSB Yes Yes Yes YesSO2 Yes Yes Yes YesctCO2 No No No NoOthers BB, P50, SBE, BB, P50, SBE, BB, P50, SBE, BB, P50, SBE,

acid-base status on acid-base status on acid-base status on acid-base status onprintout printout printout printout

SO2 & ctO2 ON/OFF Yes Yes Yes Not specified

SAMPLE VOLUME, µLNormal 55-80 60-85 50 Not specified

Micro 40-65 50-75 40 Not specified

INTEGRAL MULTI-WAVELENGTH OXIMETER No No No Not specified

VISIBLE SAMPLECHAMBER Yes Yes Yes Not specified

ANALYSIS TIME, sec ~60 ~60 ~60 ~60

ELECTRODEMAINTENANCE Premembraned Premembraned Premembraned Premembraned

electrode cartridge electrode cartridge electrode cartridge electrode cartridgeor maintenance-free or maintenance-free or maintenance-free or maintenance-free

DISPLAY 15-line LCD 15-line LCD 15-line LCD 15-line LCD

PRINTOUT Thermal printer Thermal printer Thermal printer Thermal printer

Colons separate data on similar models of a device. This is the first oftwo pages coveringthe above model(s).These specificationscontinue onto thenext page.




MODEL ESCHWEILER ESCHWEILER ESCHWEILER ESCHWEILER

COMBISYS II COMBISYS II ECOSYS II MODULARBGA Plus E BGA plus E and tHb

CALIBRATION Automatic 2-point, Automatic 2-point, Automatic 2-point, Automatic 2-point,liquid calibration liquid calibration liquid calibration liquid calibrationwithout gas cylin- without gas cylin- without gas cylin- without gas cylin-ders and gas-mixing ders and gas-mixing ders and gas-mixing ders and gas-mixingdevice device device device

STANDBY MODE Yes Yes Yes Yes

INTERFACE RS232 RS232 RS232 RS232

DATA MANAGEMENT Software for online Software for online Software for online Software for onlinePC PC PC PC

USER-ENTERED DATA Patient ID and Patient ID and Patient ID and Patient ID andsample number, sample number, sample number, sample number,patient temp, tHb, patient temp, FiO2, patient temp, tHb, patient temp, FiO2,FiO2, RQ RQ FiO2, RQ RQ

BAR-CODE READER No No No Not specified

PASSWORD PROTECTION No No No Not specified

POWER REQUIREMENTS,VAC, Hz 110/120/220/240, 110/120/220/240, 110/120/220/240, 115/230,

50/60 50/60 50/60 50/60


H x W x D, cm (in) 40 x 46 x 39 40 x 46 x 39 40.2 x 28.5 x 43.5 40 x 44.5 x 41.3(15.7 x 18.1 x 15.4) (15.7 x 18.1 x 15.4) (15.8 x 11.2 x 17.1) (15.7 x 17.5 x 16.3)

WEIGHT, kg (lb) 19 (41.9) 19 (41.9) 15 (33.1) 18 (39.7)

LIST PRICE $20,000 $25,000 $12,500 $4,000-20,000

Warranty 2 years 2 years 2 years 2 years

OTHER SPECIFICATIONS Service diagnostic Service diagnostic Service diagnostic Fully modular;program; electrode program; electrode program; electrode upgrade at any timestatus printout; status printout; status printout; channel by channel,power-failure pro- power-failure pro- power-failure pro- even at user's site;tection; economy tection; economy tection; economy onboard economy pro-program; end-point program; end-point program; end-point gram for saving re-detection; performs detection; performs detection; performs agents; performs 4040 samples/hr; 40 samples/hr; 40 samples/hr; samples/hr;mobile unit with no mobile unit with no mobile unit with no mobile unit withoutgas connections. gas connections. gas connections. gas connections.Meets requirements Meets requirements Meets requirements Meets requirementsof EMV, IEC 601-1, of EMV, IEC 601-1, of EMV, IEC 601-1, of EMV, IECand TUV. and TUV. and TUV. 601-1, and TUV.

Colons separate data on similar models of a device.




MODEL INSTRUMENTATION INSTRUMENTATION INSTRUMENTATION INSTRUMENTATIONLABORATORY LABORATORY LABORATORY LABORATORYGEM Premier 3000 GEM Premier 3100 Synthesis 10 Synthesis 15





BP, mm Hg No No No NoCa++, mmol/L 0.10-5.00 0.10-5.00 No NoHct, % 15-65 15-65 No NoK+, mmol/L 0.1-20 0.1-20 No NoNa+, mmol/L 100-200 100-200 No NopH 6.8-7.8 6.8-7.8 6.4-8.0 6.4-8.0PCO2, mm Hg 5-115 * 5-115 * 8-200 8-200PO2, mm Hg 0-760 0-760 0-800 0-800

Others Glucose PT/PT-CIT (0.8-12 None tHb (5-20 g/dL),(20-500 mg/dL), INR), APTT (20-300 O2Hb (0-100%),lactate sec), ACT (65-1,005 COHb (0-100%),(0-15 mmol/L) ** sec), ACT-LR (67-400 MetHb (0-100%),

sec), glucose (20- RHb (0-100%)-500 mg/dL), lactate(0-15 mmol/L) **

Deriveda/A No No No NoA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf Yes Yes Yes YesHb Yes Yes No MeasuredHCO3

- Yes Yes Yes YesctO2 Yes, w/co-oximeter Yes, w/co-oximeter Yes YesSB Yes Yes Yes YesSO2 Yes Yes No MeasuredctCO2 Yes Yes Yes YesOthers pAO2, paO2/pAO2, pAO2, paO2/pAO2, pH(T), PCO2(T), pH(T), PCO2(T),

RI *** RI *** PO2(T), %O2C, PAO2, PO2(T), %O2C, PAO2,PaO2/PAO2, %O2m PaO2/PAO2, %O2m

SO2 & ctO2 ON/OFF Yes *** Yes *** Yes Yes

SAMPLE VOLUME, µLNormal 135-150 135-150, 200 90 250

(50 for coag)Micro NA NA 60 100

INTEGRAL MULTI-WAVELENGTH OXIMETER No No No Yes

VISIBLE SAMPLECHAMBER No No Yes Yes



DISPLAY Touchscreen Touchscreen LCD LCD

PRINTOUT Onboard thermal, Onboard thermal, Onboard thermal, Onboard thermal,parallel printer parallel printer optional dot matrix optional dot matrix

Colons separate data on similar models of a device. This is the first of* Trending up to 150. two pages covering** When interfaced to an IL co-oximeter: tHb (4-25 mg/dL), O2Hb (0-100%), CO2Hb (0-100%), MetHb (0-100%), RHb (0-100%), the above model(s).

SO2 (0-100%). These specifications*** When interfaced to an IL co-oximeter: O2cap, CaO2, CvO2, CcO2, a-vDO2, Qsp/Qt, and P50. continue onto the

next page.




MODEL INSTRUMENTATION INSTRUMENTATION INSTRUMENTATION INSTRUMENTATIONLABORATORY LABORATORY LABORATORY LABORATORYGEM Premier 3000 GEM Premier 3100 Synthesis 10 Synthesis 15

CALIBRATION Automatic, port Automatic, port Automatic, program- Automatic, program-mable 2-point (1-8 mable 2-point (1-8hr); automatic hr); automatic1-point every 30 min 1-point every 30 min

STANDBY MODE Not specified Not specified Yes Yes

INTERFACE 3 RS232 ports, 3 RS232 ports, 4 RS232 ports, bar- 4 RS232 ports, bar-1 parallel printer 1 parallel printer code reader, co-ox, code reader, co-ox,port, bar-code port, bar-code alphanumeric key- alphanumeric key-reader, Ethernet reader, Ethernet board, parallel board, parallel

DATA MANAGEMENT Onboard, up to Onboard, up to Onboard 1-year Onboard 1-year24,000 patient and 24,000 patient and patient and QC patient and QCQC samples, remote QC samples, remote storage storagemanagement via management viaGEMweb GEMweb

USER-ENTERED DATA Patient ID, temp, Patient ID, temp, Patient ID, name, Patient ID, name,operator ID, sample operator ID, sample temp; operator ID; temp; operator ID;type, O2, FiO2%, VT, type, O2, FiO2%, VT, sample type, time sample type, timemode, mech rate, mode, mech rate, drawn; FiO2 drawn; FiO2; %FHbspon rate, MAP, PEEP * spon rate, MAP, PEEP *

BAR-CODE READER Yes Yes Yes Yes

PASSWORD PROTECTION Yes Yes Yes Yes

POWER REQUIREMENTS,VAC, Hz 100/120, 50; 100/120, 50; 100/112/115/125/220/ 100/112/115/125/220/

220/240, 60 220/240, 60 240/250, 50/60 240/250, 50/60

POWER CONSUMPTION Not specified Not specified 220 W 220 W

H x W x D, cm (in) 43.2 x 30.5 x 30.5 50.4 x 30.5 x 30.5 49 x 41 x 46 49 x 41 x 46(17 x 12 x 12) (19.8 x 12 x 12) (19.3 x 16.1 x 18.1) (19.3 x 16.1 x 18.1)

WEIGHT, kg (lb) 13.4 (29.5) 15.2 (33.5) 36.3 (80) 36.3 (80)

LIST PRICE $39,950 $44,145 $29,925 $42,000

Warranty 5 years 5 years 1 year 1 year

OTHER SPECIFICATIONS Multiuse cartridge; Multiuse cartridge; None specified. Semiquantitative75/150/300/450/600 75/150/300/450/600 bilirubin.tests; 3 menu tests; 3 menuoptions; Intelligent options; IntelligentQuality Management Quality Management(iQM). (iQM).

Colons separate data on similar models of a device.* Also peak press, time (sec), time (%), CPAP, BIPA P(I), and BIPAP(E).




MODEL INSTRUMENTATION INSTRUMENTATION INSTRUMENTATION INSTRUMENTATIONLABORATORY LABORATORY LABORATORY LABORATORYSynthesis 20 Synthesis 25 Synthesis 30 Synthesis 35





BP, mm Hg No No No NoCa++, mmol/L 0.25-4.25 0.25-4.25 0.25-4.25 0.25-4.25Hct, % 10-75 10-75 10-75 10-75K+, mmol/L 1-15 1-15 1-15 1-15Na+, mmol/L 80-200 80-200 80-200 80-200pH 6.4-8.0 6.4-8.0 6.4-8.0 6.4-8.0PCO2, mm Hg 8-200 8-200 8-200 8-200PO2, mm Hg 0-800 0-800 0-800 0-800

Others Cl- (40-160 mmol/L) tHb (5-20 g/dL), Cl- (40-160 mmol/L), tHb (5-20 g/dL),O2Hb (0-100%), glucose (15-500 O2Hb, COHb, MetHb,COHb (0-100%), mg/dL), lactate RHb (0-100%), Cl-MetHb (0-100%), (0-14 mmol/L) (40-160 mmol/L),RHb (0-100%), gluc (15-500 mg/dL),Cl- (40-160 mmol/L) lac (0-14 mmol/L)

Deriveda/A No No No NoA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf Yes Yes Yes YesHb No Measured No MeasuredHCO3

- Yes Yes Yes YesctO2 Yes Yes Yes YesSB Yes Yes Yes YesSO2 No Measured No MeasuredctCO2 Yes Yes Yes YesOthers pH(T), PCO2(T), pH(T), PCO2(T), pH(T), PCO2(T), pH(T), PCO2(T),

PO2(T), %O2C, PAO2, PO2(T), %O2C, PAO2, PO2(T), %O2C, PAO2, PO2(T), %O2C, PAO2,PaO2/PAO2, %O2m PaO2/PAO2, %O2m PaO2/PAO2, %O2m PaO2/PAO2, %O2m

SO2 & ctO2 ON/OFF Yes Yes Yes Yes

SAMPLE VOLUME, µLNormal 180 270 180 270

Micro 80 150 80 150

INTEGRAL MULTI-WAVELENGTH OXIMETER No Yes No Yes

VISIBLE SAMPLECHAMBER Yes Yes Yes Yes



DISPLAY LCD LCD LCD LCD

PRINTOUT Onboard thermal, Onboard thermal, Onboard thermal, Onboard thermal,optional dot matrix optional dot matrix optional dot matrix optional dot matrix





MODEL INSTRUMENTATION INSTRUMENTATION INSTRUMENTATION INSTRUMENTATIONLABORATORY LABORATORY LABORATORY LABORATORYSynthesis 20 Synthesis 25 Synthesis 30 Synthesis 35

CALIBRATION Automatic, program- Automatic, program- Automatic, program- Automatic, program-mable 2-point (1-8 mable 2-point (1-8 mable 2-point (1-8 mable 2-point (1-8hr); automatic hr); automatic hr); automatic hr); automatic1-point every 30 min 1-point every 30 min 1-point every 30 min 1-point every 30 min


INTERFACE 4 RS232 ports, bar- 4 RS232 ports, bar- 4 RS232 ports, bar- 4 RS232 ports, bar-code reader, co-ox, code reader, co-ox, code reader, co-ox, code reader, co-ox,alphanumeric key- alphanumeric key- alphanumeric key- alphanumeric key-board, parallel board, parallel board, parallel board, parallel

DATA MANAGEMENT Onboard 1-year Onboard 1-year Onboard 1-year Onboard 1-yearpatient and QC patient and QC patient and QC patient and QCstorage storage storage storage

USER-ENTERED DATA Patient ID, name, Patient ID, name, Patient ID, name, Patient ID, name,temp; operator ID; temp; operator ID; temp; operator ID; temp; operator ID;sample type, time sample type, time sample type, time sample type, timedrawn; FiO2 drawn; FiO2; %FHb drawn; FiO2 drawn; FiO2; %FHb


PASSWORD PROTECTION Yes Yes Yes Yes

POWER REQUIREMENTS,VAC, Hz 100/112/115/125/220/ 100/112/115/125/220/ 100/112/115/125/220/ 100/112/115/125/220/

240/250, 50/60 240/250, 50/60 240/250, 50/60 240/250, 50/60

POWER CONSUMPTION 220 W 220 W 220 W 220 W

H x W x D, cm (in) 49 x 41 x 46 49 x 41 x 46 49 x 41 x 46 49 x 41 x 46(19.3 x 16.1 x 18.1) (19.3 x 16.1 x 18.1) (19.3 x 16.1 x 18.1) (19.3 x 16.1 x 18.1)

WEIGHT, kg (lb) 36.3 (80) 36.3 (80) 36.3 (80) 36.3 (80)

LIST PRICE $38,325 $48,300 $42,000 $52,500


OTHER SPECIFICATIONS None specified. Semiquantitative None specified. Semiquantitativebilirubin. bilirubin.





MODEL INSTRUMENTATION INSTRUMENTATION ITC i-STATLABORATORY LABORATORY FAILED TO RESPOND *Synthesis 40 Synthesis 45 IRMA SL Blood Portable Clinical

Analysis System Analyzer





BP, mm Hg No No 350-900 Not specifiedCa++, mmol/L 0.25-4.25 0.25-4.25 0.20-5.00 0.25-2.50Hct, % 10-75 10-75 10-80 10-75K+, mmol/L 1-15 1-15 1.0-20.0 2.0-9.0Na+, mmol/L 80-200 80-200 80-200 100-180pH 6.4-8.0 6.4-8.0 6.0-8.0 6.5-8.0PCO2, mm Hg 8-200 8-200 4-200 5-130PO2, mm Hg 0-800 0-800 20-700 5-800

Others Cl- (40-160 mmol/L), tHb (5-20 g/dL), Glucose (20-500 BUN (3-140 mmol/L),glucose (15-500 O2Hb, COHb, MetHb, mg/dL), BUN (3-150 Cl- (65-140 mmol/L),mg/dL), lactate RHb (0-100%), mg/dL), Cl- glucose (20-450(0-14 mmol/L) Cl- (40-160 mmol/L), (30-150 mmol/L), mmol/L)

lac (0-14 mmol/L) urea (1.1-53.4mmol/L)

Deriveda/A No No No NoA-aDO2 Yes Yes No NoBE Yes Yes ±99.9 mmol/L YesBEecf Yes Yes ±99.9 mmol/L YesHb No Measured 3.4-27.2 g/dL ** YesHCO3

- Yes Yes 0-99.9 mmol/L YesctO2 Yes Yes No NoSB Yes Yes No NoSO2 No Measured 0-100% YesctCO2 Yes Yes 0-99.9 mmol/L YesOthers pH(T), PCO2(T), pH(T), PCO2(T), No AG

PO2(T), %O2C, PAO2, PO2(T), %O2C, PAO2,PaO2/PAO2, %O2m PaO2/PAO2, %O2m

SO2 & ctO2 ON/OFF Yes Yes Yes No

SAMPLE VOLUME, µLNormal 195 285 200 65-85 (depends on

cartridge type)Micro 95 165 125 NA

INTEGRAL MULTI-WAVELENGTH OXIMETER No Yes No No


ANALYSIS TIME, sec 60 60 <90 120

ELECTRODEMAINTENANCE None None NA (disposable) None

DISPLAY LCD LCD LCD touchscreen LCD

PRINTOUT Onboard thermal, Onboard thermal, Built-in roll Optional rolloptional dot matrix optional dot matrix printer printer

Colons separate data on similar models of a device. This is the first of* Specifications current as of October 2003. two pages covering** Other ranges also available. Provided by ITC. the above model(s).

These specificationscontinue onto thenext page.




MODEL INSTRUMENTATION INSTRUMENTATION ITC i-STATLABORATORY LABORATORY FAILED TO RESPOND *Synthesis 40 Synthesis 45 IRMA SL Blood Portable Clinical

Analysis System Analyzer

CALIBRATION Automatic, program- Automatic, program- Automatic before Self-calibratingmable 2-point (1-8 mable 2-point (1-8 each test cartridges (1-point)hr); automatic hr); automatic1-point every 30 min 1-point every 30 min

STANDBY MODE Yes Yes NA Yes

INTERFACE 4 RS232 ports, bar- 4 RS232 ports, bar- RS232 modem To LIS/HIScode reader, co-ox, code reader, co-ox,alphanumeric key- alphanumeric key-board, parallel board, parallel

DATA MANAGEMENT Onboard 1-year Onboard 1-year IDMS, comprehensive Stores 50 patientpatient and QC patient and QC data and POCT pro- testsstorage storage gram management

capabilities

USER-ENTERED DATA Patient ID, name, Patient ID, name, User and patient ID, Patient temp and ID,temp; operator ID; temp; operator ID; patient temp, QC lot FiO2, sample type,sample type, time sample type, time numbers, QC ranges, operator ID, 3 user-drawn; FiO2 drawn; FiO2; %FHb Hb, sample type, defined fields

sample site **

BAR-CODE READER Yes Yes Yes No

PASSWORD PROTECTION Yes Yes Yes No

POWER REQUIREMENTS,VAC, Hz 100/112/115/125/220/ 100/112/115/125/220/ 100/240, 50/60 9 V lithium

240/250, 50/60 240/250, 50/60 (charger and AC batteries (2)adapter) ***

POWER CONSUMPTION 220 W 220 W 1.2 A None

H x W x D, cm (in) 49 x 41 x 46 49 x 41 x 46 29.2 x 24.1 x 12.7 21 x 6.4 x 4.8(19.3 x 16.1 x 18.1) (19.3 x 16.1 x 18.1) (11.5 x 9.5 x 5) (8.3 x 2.5 x 1.9)

WEIGHT, kg (lb) 36.3 (80) 36.3 (80) 2.4 (5.3) 0.53 (1.2)

LIST PRICE $48,300 $60,375 $8,900 $5,000


OTHER SPECIFICATIONS None specified. Semiquantitative Interactive touch- Handheld POCbilirubin. screen; complete QC analyzer;

menu with internal disposableEQC, QC lockout, cartridges containuser ID lockout, sensors, heatinghighly configurable elements, andsettings, room-temp- buffered calibrants;erature cartridge no maintenance orstorage; calibration gas tank required;before sample intro- used cartridge sealsduction; battery or in waste.AC power; very lowmaintenance;portable to bedside.Meets requirementsof CSA Class 2, EMC,ISO 9001, and UL544.

Colons separate data on similar models of a device.* Specifications current as of October 2003.** Also FiO2, code, room air, oxygen therapy mode, vent settings, mask/collar mode, and patient notes.*** Also 7.2 V, 2 A rechargeable battery or AC adapter (analyzer).




MODEL JOKOH MEDICA MEDICA METRACORFAILED TO RESPOND * FAILED TO RESPOND **JBA-200 EasyBloodGas EasyStat VIA-ABG

WHERE MARKETED Worldwide Worldwide Worldwide USA

FDA CLEARANCE Not specified Yes Yes Yes

CE MARK (MDD) Not specified Yes Yes No


BP, mm Hg 600-900 500-800 Not specified NoCa++, mmol/L No No 0.25-5.00 NoHct, % No No 10-70 12-70K+, mmol/L No No 1.0-20.0 1-20Na+, mmol/L No No 80-200 80-190pH 6.000-8.000 6.900-7.900 6.500-8.000 6.80-7.70PCO2, mm Hg 5-250 8.0-150.0 5.0-150.0 10-150PO2, mm Hg 0-800 10-700 5-700 20-699

Others None specified None specified Hct None

Deriveda/A Yes No Not specified NoA-aDO2 Yes Yes Not specified NoBE Yes Yes Yes YesBEecf No Yes Yes NoHb No No Not specified YesHCO3

- Yes Yes Yes YesctO2 No No Yes NoSB Yes Yes Yes NoSO2 Yes Yes Yes YesctCO2 Yes Yes Not specified NoOthers BB, ctCO2, FiO2, SBE pH(T), PCO2(T), THb TCO2

PO2(T), RI

SO2 & ctO2 ON/OFF No No Not specified No

SAMPLE VOLUME, µLNormal 100 (aspirated), 100 120 0

150 (injected)Micro NA 75 95 NA

INTEGRAL MULTI-WAVELENGTH OXIMETER No No Not specified No

VISIBLE SAMPLECHAMBER Yes No Not specified No

ANALYSIS TIME, sec 100 125 <120 70

ELECTRODEMAINTENANCE Manual replacement None None Disposable, 3-day

of membranes use

DISPLAY LCD LCD Not specified Vacuum fluorescent

PRINTOUT Optional ticket Roll printer Not specified Thermalprinter

Colons separate data on similar models of a device. This is the first of* Specifications current as of September 2002. two pages covering** Specifications current as of October 2003. the above model(s).





MODEL JOKOH MEDICA MEDICA METRACORFAILED TO RESPOND * FAILED TO RESPOND **JBA-200 EasyBloodGas EasyStat VIA-ABG

CALIBRATION Automatic 2-point Automatic 1-point Automatic Initial 2-point;each analysis; automatic 1-pointadjustable 2-point every 10 minevery 8 hr after initial

STANDBY MODE Yes Yes Not specified Yes

INTERFACE RS232C RS232 RS232 RS232

DATA MANAGEMENT Yes 64 patient results Storage of patient Yesw/operator ID, date and QC datatime, patient ID, upto 30 QC results foreach of 3 levels

USER-ENTERED DATA Patient temp, Hb, BP Patient ID and temp, Not specified Patient ID, name,FiO2, Hb, operator tempID

BAR-CODE READER No Yes Not specified No

PASSWORD PROTECTION No Yes Not specified No

POWER REQUIREMENTS,VAC, Hz 110/120/220/240, 110/120/220/240, 100/115/220, 110/120/220/240,

50/60 50/60 50/60 50/60

POWER CONSUMPTION 200 W 90 VA Not specified 75 VA

H x W x D, cm (in) 46 x 33 x 35 32 x 37 x 18 37 x 32 x 18 21.6 x 24.1 x 22.9(18.1 x 13 x 14) (12.6 x 14.6 x 7.1) (14.5 x 12.5 x 7) (8.5 x 9.5 x 9)

WEIGHT, kg (lb) 26 (57) 7.3 (16) 7.7 (17) 7.3 (16)

LIST PRICE Not specified $10,000 $12,500 Not specified


OTHER SPECIFICATIONS Self-diagnostics; Disposable reagent Disposable reagent Real-time, patient-data recorded on module provides all module provides attached, ex vivoacid/base plot with calibrants, collects calibrants, collects monitors for bloodoptional ticket all waste; no gas waste; no gas tanks; gases, electrolytes,printer. Meets tanks; divides into divides into 3 and Hct; bloodrequirements of IEC 3 modules for user modules for user sample automaticallyand JIS. accessibility; dis- accessibility; dis- returned to patient.

posable electrodes posable electrodeswith integral with integralmembranes; computer- membranes; computer-prompted operation; prompted operation;automatic probe probe wiping;wiping; diagnostic diagnostic software.software. Complieswith CSA and ETL.

Colons separate data on similar models of a device.* Specifications current as of September 2002.** Specifications current as of October 2003.




MODEL METRACOR NOVA NOVA NOVAFAILED TO RESPOND *VIA-LVM Stat Profile Stat Profile pHOx Stat Profile pHOx

Critical Care Xpress Basic : pHOx Plus **

WHERE MARKETED USA Worldwide Worldwide Worldwide


CE MARK (MDD) No Yes Yes Yes


BP, mm Hg No 400-800 400-800 400-800Ca++, mmol/L No 0.1-2.7 No See footnote ***Hct, % 12-70 12-70 No : 12-70 12-70K+, mmol/L 1-20 1-20 No 1-20Na+, mmol/L 80-190 80-200 No 80-200pH 6.80-7.70 6.5-8.0 6.5-8.0 6.5-8.0PCO2, mm Hg 10-150 3-200 3-200 3-200PO2, mm Hg 20-699 0-800 0-800 0-800

Others None Cl- (50-200 mmol/L), None Glucose (15-500Mg++ (0.1-1.5 mmol/ mg/dL) : GlucoseL), glucose (15-500 (15-500 mg/dL) :mg/dL), lactate (0.3 Glucose (15-500 mg/-20 mmol/L), creati- dL), lactate (0.3-20nine (0.2-20 mg/dL), mmol/L)BUN (3-100 mg/dL)

Deriveda/A No Yes Yes YesA-aDO2 No Yes Yes YesBE Yes Yes Yes YesBEecf No Yes Yes YesHb Yes 4-24 g/dL No : 4-24 4-24 g/dLHCO3

- Yes Yes Yes YesctO2 No Yes Yes YesSB No Yes Yes YesSO2 Yes 30-100% (measured) No : 30-100% † 30-100% (measured)ctCO2 No Yes Yes YesOthers TCO2 Not specified TCO2, A Not specified

SO2 & ctO2 ON/OFF No Yes Yes Yes

SAMPLE VOLUME, µLNormal 0 150 70 115 : 125 : 125

Micro NA 60 ABG, 110 full 45 55 : 60 : 60panel

INTEGRAL MULTI-WAVELENGTH OXIMETER No Yes Yes Yes

VISIBLE SAMPLECHAMBER No No Yes Yes

ANALYSIS TIME, sec 70 62/134 45 50 : 52 : 52

ELECTRODEMAINTENANCE Disposable, 3-day Some maintenance- Some maintenance- Some maintenance-

use free, some pre- free, some pre- free, some pre-membraned snap-on membraned snap-on membraned snap-oncaps caps caps

DISPLAY Vacuum fluorescent Color touchscreen VGA VGA

PRINTOUT Thermal Thermal printer, Thermal printer, dot Thermal printer, dotexternal options matrix optional matrix optional

Colons separate data on similar models of a device. This is the first of* Specifications current as of October 2003. two pages covering** Plus : Plus C : Plus L. the above model(s).*** Stat Profile pHOx Plus has Ca++ (0.1-2.7 mmol/L) or Cl- (50-200 mmol/L) : Plus C has Ca++ (0.1-2.7 mmol/L) and Cl- (50-200 These specifications

mmol/L) : Plus L has Ca++ (0.1-2.7 mmol/L) or Cl- (50-200 mmol/L). continue onto the† Measured. next page.




MODEL METRACOR NOVA NOVA NOVAFAILED TO RESPOND *VIA-LVM Stat Profile Stat Profile pHOx Stat Profile pHOx

Critical Care Xpress Basic : pHOx Plus **

CALIBRATION Initial 2-point; Automatic (2-point Automatic (2-point Automatic (2-pointautomatic 1-point every 2-6 hr; every 2-6 hr; every 2-6 hr;every 30 min 1-point with every 1-point with every 1-point with everyafter initial sample; gas cal sample; gas cal sample; gas cal

every 30-45 min) every 30-45 min) every 30-45 min)


INTERFACE RS232 RS232, Ethernet, RS232, ASTM RS232, ASTMUSB, HL7, ASTM

DATA MANAGEMENT Yes Onboard data Onboard QC, Windows Onboard patient andmanagement including NT QC storagepatient, QC, maint,and operationalparameters

USER-ENTERED DATA Patient ID, name, User selected from Patient ID and temp, Patient ID and temp,temp, catheter size HL7 library FiO2, accession FiO2, accession

number, vent number, ventsetting, draw site setting, draw site

BAR-CODE READER No Optional Optional Optional

PASSWORD PROTECTION No Yes, multilevel Yes Yes

POWER REQUIREMENTS,VAC, Hz 110/120/220/240, 90-264, 50/60 90-264, 50/60 90-264, 50/60

50/60

POWER CONSUMPTION 75 VA 350 W 200 W 200 W

H x W x D, cm (in) 21.6 x 24.1 x 22.9 43 x 56 x 43 38 x 30.5 x 38 38 x 30 x 38(8.5 x 9.5 x 9) (16.9 x 22.3 x 16.9) (15 x 12 x 15) (15 x 11.8 x 15)

WEIGHT, kg (lb) 7.3 (16) 24.1 (53.1) 8.2 (18.1) 8.2 (18.1)

LIST PRICE Not specified $25,000-59,000 $12,000 : $15,000 $29,000 : $32,000 :$32,000


OTHER SPECIFICATIONS Real-time, patient- User-configurable Liquid calibration; Liquid calibration;attached, ex vivo test menu; automated onboard QC solutions onboard QC solutionsmonitors for blood onboard QC; liquid with automatic with automaticgases, electrolytes, calibration; open- scheduled QC scheduled QCand Hct; blood architecture user analysis and data analysis and datasample automatically interface; unlimited storage; optional storage; optionalreturned to patient. data storage; user- co-oximeter. co-oximeter.

configurablereports. CIC, NCCLS,and POCT1-Acompliant.

Colons separate data on similar models of a device.* Specifications current as of October 2003.** Plus : Plus C : Plus L.




MODEL RADIOMETER RADIOMETER RADIOMETER RADIOMETER

ABL5 ABL77 Series ABL800 FLEX Series NPT7

WHERE MARKETED Worldwide Worldwide Worldwide Not specified




BP, mm Hg 450-800 0-800 450-800 NoCa++, mmol/L No 0.20-5.00 0.20-10.00 NoHct, % No 10-80 Derived 0-100K+, mmol/L No 1.00-10.00 0.5-25.0 NoNa+, mmol/L No 80-200 7-350 NopH 6.3-8.0 6.80-7.80 6.3-8.0 6.5-7.8PCO2, mm Hg 5-250 0-120 5-250 5-250PO2, mm Hg 0-800 0-600 0-800 0-800

Others None Cl- (60-200 mmol/L) Cl- (7-350 mmol/L), SO2, O2Hb, COHb,glucose (0-1,081 MetHb, HHb, HbFg/dL), ctBil (0-58.5 (0-100%)mg/dL), lactate(0-30.0 mmol/L) *

Deriveda/A No Yes Yes YesA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf Yes Yes Yes YesHb No Yes Measured MeasuredHCO3

- Yes Yes Yes YesctO2 Yes Yes Yes YesSB Yes Yes Yes YesSO2 Yes Yes Yes YesctCO2 Yes Yes Yes YesOthers cH+, cH+(T), Ca++ (7.40), ctO2, Up to 45, including PCO2(T), pH(T),

PCO2(T), pH(T), pH(T), PCO2(T), AG, P50, F shunt, Qx PO2(T)PO2(T) PO2(T)


SAMPLE VOLUME, µLNormal 85 ~70 195/95 syringe/cap- 90 µL syringe/cap-

illary full panel illaryMicro 35 (pH-only mode) No 35-95 µL plus Not specified

FLEXMODE

INTEGRAL MULTI-WAVELENGTH OXIMETER No No 128 wavelength Yes


ANALYSIS TIME, sec 60 <70 60-80 60

ELECTRODEMAINTENANCE Prefilled membrane None Prefilled membrane None

cartridges cartridges

DISPLAY LCD TFT VGA color 10.4" TFT VGA color LCD touchscreentouchscreen touchscreen

PRINTOUT Roll printer Thermal printer Thermal printer Thermal printer

Colons separate data on similar models of a device. This is the first of* Also tHb (0-27.7 g/dL), SO2, O2Hb, COHb, MetHb, HHb, HbF (0-100%). two pages covering

the above model(s).These specificationscontinue onto thenext page.




MODEL RADIOMETER RADIOMETER RADIOMETER RADIOMETER

ABL5 ABL77 Series ABL800 FLEX Series NPT7

CALIBRATION Automatic Automatic, program- Automatic, program- Automatic with eachmable 2-point mable 1- and 2-point sample

STANDBY MODE Yes No Yes Yes

INTERFACE RS232 (optional) RS232, RJ45 RS232, Ethernet RS232, RJ45 Ether-Ethernet, 2-way port, software, 2- net, 2-level ASTMASTM, HL7 protocols level ASTM and HL7 protocols

user customized

DATA MANAGEMENT Stores last patient, 500 patient results, Defaults to 2,000 Active log of 500calibration, and 500 calibration patient results, analyzer events andQC reports results, 500 QC, 150 1,500 QC, 3,000 sys- 60 patient results,

user IDs, floppy tem messages, 1,000 additional onboarddrive calibration results storage available

USER-ENTERED DATA Patient temp and ID, Patient ID, operator Patient temp, ID, Patient temp, ID,tech ID, FiO2 ID, draw site, acc- height, weight, sex, operator ID, RQ,

ession number, time, age, name; tech ID; FiO2, P50(st)type, temp, GIU dept; sample type;correction, FiO2 FiO2, etc. *

BAR-CODE READER Yes Yes Built-in Optional

PASSWORD PROTECTION No Yes Customized Yes

POWER REQUIREMENTS,VAC, Hz 110/120/230/240, 100-240, 50/60 100-240, 50/60 100-240, 50/60

50/60; UPS available

POWER CONSUMPTION 60 VA Not specified 250 VA 160 VA

H x W x D, cm (in) 39 x 34 x 20 33 x 20 x 23 40 x 70 x 55 26 x 34 x 42(15.4 x 13.4 x 7.9) (13 x 7.9 x 9.1) (15.7 x 27.6 x 21.7) (10 x 13 x 17)

WEIGHT, kg (lb) 8.8 (19) 7.2 (16) 26-30 (57.3-66.1) 11 (24)

LIST PRICE Not specified Not specified Not specified Not specified


OTHER SPECIFICATIONS Disposable waste Portable; customiz- Window XP OX; FLEX- Dri-tek cuvettes dosystem; foil-sealed able configuration CARE customer sup- not require wetreagent cartridges; and test panels; QC port program; FLEX- reagents; built-inoptional interface and user lockouts; PAC inventory sys- 2-level QC system;for ticket printer floppy drive; LIS/ tem; onboard auto QC built-in batteryand computer. Meets HIS interface; net- module, gas bottles, backup; 3-monthrequirements of CSA, work ready; bar-code acid-base chart; use cartridge life;IEC, and UL. EMC reader; disposable disposable waste no cartridge warm-upemission and multitest sensor system; configurable period.immunity. cassette and cali- from 3 to 17 para-

bration pack. EMC meters; help/troubleemission and shooting function w/immunity. Meets videos; LIS/HIS in-requirements of TUV terface; analyzerand UL. control module and

remote supportaccess via RADIANCE.

Colons separate data on similar models of a device.* Also can be unlimited number of user-defined fields with drop-down box data.




MODEL ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS

Compact 3 * OMNI 1 * OMNI 2 * OMNI 3 *

WHERE MARKETED Worldwide, not USA Worldwide Worldwide Worldwide




BP, mm Hg 300-800 300-800 300-800 300-800Ca++, mmol/L No No No NoHct, % No No No NoK+, mmol/L No No No NoNa+, mmol/L No No No NopH 6.000-8.000 6.0-8.0 6.0-8.0 6.0-8.0PCO2, mm Hg 4-200 4-200 4-200 4-200PO2, mm Hg 0-740 0-800 0-800 0-800

Others None None tHb (3-24 g/dL) ctHb (3-24 g/dL);O2Hb, HHb, COHb,MetHb, SulfHb(all 0-100%)

Deriveda/A No Yes Yes YesA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf Yes Yes Yes YesHb No No Yes YesHCO3

- Yes Yes Yes YesctO2 No Yes Yes YesSB Yes Yes Yes YesSO2 Yes Yes Yes YesctCO2 Yes Yes Yes YesOthers BB, cH+, pH(T), FO2Hb, BB, pHst, pH(T), pHst, cH+, pH(T), pHst, cH+,

PCO2(T), PO2(T) cH+, cH(T), RI, cH(T), FO2Hb ** cH(T), FO2Hb **RI(T), pH(T) **

SO2 & ctO2 ON/OFF No Yes Yes Yes


Micro 25 (step mode) NA 40 blood gas/pH 40 blood gas/pHonly only

INTEGRAL MULTI-WAVELENGTH OXIMETER No No No Yes



ELECTRODEMAINTENANCE Zero-maintenance or Zero-maintenance Zero-maintenance Zero-maintenance

optional premem- electrodes and electrodes and electrodes andbraned electrode reference system reference system reference systemhousing replacement

DISPLAY LCD 10" active-color 10" active-color 10" active-colortouchscreen touchscreen touchscreen

PRINTOUT Thermal printer, Roll printer, Roll printer, Roll printer,optional ticket optional ticket or optional ticket or optional ticket orprinter line printer line printer line printer

Colons separate data on similar models of a device. This is the first of* Models listed are currently marketed; specifications current as of September 2002. two pages covering** PCO2(T), PO2(T), PAO2, PAO2(T), A-aDO2(T), and a/AO2(T) also available. the above model(s).






Compact 3 * OMNI 1 * OMNI 2 * OMNI 3 *

CALIBRATION Automatic, Automatic, Automatic, Automatic,programmable 1- and programmable 1- and programmable 1- and programmable 1- and2-point 2-point 2-point 2-point


INTERFACE RS232 (3) RS232 (4); RS232 (4); RS232 (4);1 parallel external 1 parallel external 1 parallel externalVGA, keyboard, VGA, keyboard, keyboard, bar-codebar-code scanner bar-code scanner scanner

DATA MANAGEMENT Onboard QC, stores Onboard data manager Onboard data manager Onboard data managerlast 3 patient re- stores >50,000 stores >50,000 stores >50,000sults, error logbook patient results, 1- patient results, 1- patient results, 1-

year QC, calibration year QC, calibration year QC, calibrationand maintenance logs and maintenance logs and maintenance logs

USER-ENTERED DATA Patient temp, FiO2, Patient name, ID, Patient name, ID, Patient name, ID,RQ, Hb (adult or sex, DOB, physician, sex, DOB, physician, sex, DOB, physician,fetal), P50, tHb blood type, Allen blood type, Allen blood type, Allen

test, puncture site, test, puncture site, test, puncture site,sample source ** sample source ** sample source **


PASSWORD PROTECTION Yes 4-level security 4-level security 4-level security

POWER REQUIREMENTS,VAC, Hz 100-240, 100-240, 100-240, 100-240,

50/60 50/60 50/60 50/60

POWER CONSUMPTION 65 VA, max 110 160 VA 160 VA 160 VA

H x W x D, cm (in) 34 x 34 x 31.5 60 x 53 x 47 60 x 53 x 47 60 x 53 x 47(13.4 x 13.4 x 12.4) (23.6 x 20.9 x 18.5) (23.6 x 20.9 x 18.5) (23.6 x 20.9 x 18.5)

WEIGHT, kg (lb) 13 (28.7) 36 (79) 36 (79) 40 (88)

LIST PRICE $16,995 $29,900 $31,900 $39,900

Warranty 1 year, including 1 year 1 year 1 yearelectrodes

OTHER SPECIFICATIONS User interface; di- Keyboard; random- Keyboard; random- Keyboard; random-agnostic program; access test selec- access test selec- access test selec-power-failure pro- tivity; onboard help tivity; onboard help tivity; onboard helptection; interface functions; sealed functions; sealed functions; sealedfor co-oximeter/AVL waste container; no waste container; no waste container; noelectrolyte analy- gases needed; up- gases needed; up- gases needed; up-zer/ticket printer/ gradable to add gradable to add gradable to addcomputer/bar-code electrolyte, co-ox, electrolyte, co-ox, electrolyte orscanner/service and metabolite and metabolite metabolitemodem; password module; optional module; optional module; optionalprotection; standard remote diagnostics remote diagnostics remote diagnosticsor SI units. Meets via modem; optional via modem; optional via modem; optionalrequirements of CE AutoQC unit for AutoQC unit for AutoQC unit forand CSA. automatic QC automatic QC automatic QC

measurement and measurement and measurement andevaluation with auto evaluation with auto evaluation with autoparameter lock/ parameter lock/ parameter lock/unlock features. unlock features. unlock features.Meets requirements Meets requirements Meets requirementsof CSA and OVE. of CSA and OVE. of CSA and OVE.

Colons separate data on similar models of a device.* Models listed are currently marketed; specifications current as of September 2002.** Also 33 patient and sample input fields.





OMNI 4 * OMNI 5 * OMNI 6 * OMNI 7 *





BP, mm Hg 300-800 300-800 300-800 300-800Ca++, mmol/L 0.1-6.0 0.1-6.0 0.1-6.0 0.1-6.0Hct, % 10-80 10-80 10-80 10-80K+, mmol/L 0.2-20 0.2-20 0.2-20 0.2-20Na+, mmol/L 20-250 20-250 20-250 20-250pH 6.0-8.0 6.0-8.0 6.0-8.0 6.0-8.0PCO2, mm Hg 4-200 4-200 4-200 4-200PO2, mm Hg 0-800 0-800 0-800 0-800

Others Cl- (20-250 mmol/L) Cl- (20-250 mmol/L), Cl- (20-250 mmol/L), Cl- (20-250 mmol/L),tHb (3-24 g/dL) ctHb (3-24 g/dL); glu (9-720 mg/dL),

O2Hb, HHb, COHb, lac (0.2-20 mmol/L),MetHb, SulfHb BUN (1.4-112 mg/dL,(all 0-100%) 0.5-40 mmol/L)

Deriveda/A Yes Yes Yes YesA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf Yes Yes Yes YesHb Yes Yes Yes YesHCO3

- Yes Yes Yes YesctO2 Yes Yes Yes YesSB Yes Yes Yes YesSO2 Yes Yes Yes YesctCO2 Yes Yes Yes YesOthers pH(T), pHst, cH+, pH(T), pHst, cH+, pH(T), pHst, cH+, pH(T), pHst, cH+,

cH(T), FO2Hb ** cH(T), FO2Hb ** cH(T), FO2Hb ** cH(T), FO2Hb **



Micro 40 blood gas/pH 40 blood gas/pH 40 blood gas/pH 40 blood gas/pH on-only only only ly, 65 glu/lac only

INTEGRAL MULTI-WAVELENGTH OXIMETER No No Yes No



ELECTRODEMAINTENANCE Zero-maintenance Zero-maintenance Zero-maintenance Zero-maintenance

electrodes and electrodes and electrodes and electrodes andreference system reference system reference system reference system

DISPLAY 10" active-color 10" active-color 10" active-color 10" active-colortouchscreen touchscreen touchscreen touchscreen

PRINTOUT Roll printer, Roll printer, Roll printer, Roll printer,optional ticket or optional ticket or optional ticket or optional ticket orline printer line printer line printer line printer







OMNI 4 * OMNI 5 * OMNI 6 * OMNI 7 *

CALIBRATION Automatic, Automatic, Automatic, Automatic,programmable 1- and programmable 1- and programmable 1- and programmable 1- and2-point 2-point 2-point 2-point


INTERFACE RS232 (4); RS232 (4); RS232 (4); RS232 (4);1 parallel external 1 parallel external 1 parallel external 1 parallel externalkeyboard, bar-code keyboard, bar-code keyboard, bar-code keyboard, bar-codescanner scanner scanner scanner

DATA MANAGEMENT Onboard data manager Onboard data manager Onboard data manager Onboard data managerstores >50,000 stores >50,000 stores >50,000 stores >50,000patient results, 1- patient results, 1- patient results, 1- patient results, 1-year QC, calibration year QC, calibration year QC, calibration year QC, calibrationand maintenance logs and maintenance logs and maintenance logs and maintenance logs

USER-ENTERED DATA Patient name, ID, Patient name, ID, Patient name, ID, Patient name, ID,sex, DOB, physician, sex, DOB, physician, sex, DOB, physician, sex, DOB, physician,blood type, Allen blood type, Allen blood type, Allen blood type, Allentest, puncture site, test, puncture site, test, puncture site, test, puncture site,sample source ** sample source ** sample source ** sample source **


PASSWORD PROTECTION 4-level security 4-level security 4-level security 4-level security

POWER REQUIREMENTS,VAC, Hz 100-240, 100-240, 100-240, 100-240,

50/60 50/60 50/60 50/60


H x W x D, cm (in) 60 x 53 x 47 60 x 53 x 47 60 x 53 x 47 60 x 53 x 47(23.6 x 20.9 x 18.5) (23.6 x 20.9 x 18.5) (23.6 x 20.9 x 18.5) (23.6 x 20.9 x 18.5)

WEIGHT, kg (lb) 36 (79) 36 (79) 40 (88) 36 (79)

LIST PRICE $39,900 $41,900 $49,900 $45,900


OTHER SPECIFICATIONS Keyboard; random- Keyboard; random- Keyboard; random- Keyboard; random-access test selec- access test selec- access test selec- access test selec-tivity; onboard help tivity; onboard help tivity; onboard help tivity; onboard helpfunctions; sealed functions; sealed functions; sealed functions; sealedwaste container; no waste container; no waste container; no waste container; nogases needed; up- gases needed; up- gases needed; up- gases needed; up-gradable to add gradable to add gradable to add gradable to addco-ox or metabolite co-ox or metabolite metabolite module; future BUN; optionalmodule; optional module; optional optional remote remote diagnosticsremote diagnostics remote diagnostics diagnostics via via modem; optionalvia modem; optional via modem; optional modem; optional AutoQC unit forAutoQC unit AutoQC unit AutoQC unit for automatic QCfor automatic QC for automatic QC automatic QC measurement andmeasurement and measurement and measurement and evaluation with autoevaluation with auto evaluation with auto evaluation with auto parameter lock/parameter lock/ parameter lock/ parameter lock/ unlock features.unlock features. unlock features. unlock features. Meets requirementsMeets requirements Meets requirements Meets requirements of CSA and OVE.of CSA and OVE. of CSA and OVE. of CSA and OVE.





MODEL ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS TECHNO MEDICA

OMNI 8 * OMNI 9 * OMNI C * GASTAT-601


FDA CLEARANCE Yes Yes Yes No



BP, mm Hg 300-800 300-800 300-800 500-800 TorrCa++, mmol/L 0.1-6.0 0.1-6.0 0.1-6.0 NoHct, % 10-80 10-80 10-80 15-65K+, mmol/L 0.2-20 0.2-20 0.2-20 NoNa+, mmol/L 20-250 20-250 20-250 NopH 6.0-8.0 6.0-8.0 6.0-8.0 6.000-8.000PCO2, mm Hg 4-200 4-200 4-200 10.0-200.0PO2, mm Hg 0-800 0-800 0-800 5.0-760 Torr

Others Cl- (20-250 mmol/L), Cl- (20-250 mmol/L), Cl- (20-250 mmol/L), NonectHb (10-80%), ctHb (10-80%), tHb (5-25 g/dL),glu (9-720 mg/dL), O2Hb (0-100%), SO2 (60-100%)lac (0.2-20 mmol/L) glu (9-720 mg/dL),

lac (0.2-20 mmol/L)

Deriveda/A Yes Yes Yes NoA-aDO2 Yes Yes Yes YesBE Yes Yes Yes YesBEecf Yes Yes Yes NoHb Yes Yes No YesHCO3

- Yes Yes Yes YesctO2 Yes Yes Yes YesSB Yes Yes Yes YesSO2 Yes Yes Yes YesctCO2 Yes Yes Yes YesOthers pH(T), pHst, cH+, pH(T), pHst, cH+, pH(T), nCa++, OSM, None specified

cH(T), FO2Hb ** cH(T), FO2Hb ** 35 calculated/derived values



Micro 40 blood gas/pH on- 40 blood gas/pH on- NA 45ly, 65 glu/lac only ly, 65 glu/lac only

INTEGRAL MULTI-WAVELENGTH OXIMETER No Yes No No

VISIBLE SAMPLECHAMBER Yes Yes No Yes


ELECTRODEMAINTENANCE Zero-maintenance Zero-maintenance Zero-maintenance None

electrodes and electrodes and electrodes andreference system reference system reference system

DISPLAY 10" active-color 10" active-color 5.7" flat color Full color back-touchscreen touchscreen touchscreen lit display

PRINTOUT Roll printer, Roll printer, Thermal printer Roll printeroptional ticket or optional ticket or with optional cutterline printer line printer






MODEL ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS TECHNO MEDICA

OMNI 8 * OMNI 9 * OMNI C * GASTAT-601

CALIBRATION Automatic, Automatic, Automatic, Automatic, program-programmable 1- and programmable 1- and programmable 1- and mable 1- and 2-point2-point 2-point 2-point calibration


INTERFACE RS232 (4); RS232 (4); RS232 TCP/IP, RS232C1 parallel external 1 parallel externalkeyboard, bar-code keyboard, bar-codescanner scanner

DATA MANAGEMENT Onboard data manager Onboard data manager 10,000 patient Yesstores >50,000 stores >50,000 records, 1-year QC/patient results, 1- patient results, 1- maintenance logs,year QC, calibration year QC, calibration 6 monthsand maintenance logs and maintenance logs calibration logs

USER-ENTERED DATA Patient name, ID, Patient name, ID, Patient ID, date, Patient ID, patientsex, DOB, physician, sex, DOB, physician, time, 65 patient and temp, Hb, FiO2, BPblood type, Allen blood type, Allen sample input fieldstest, puncture site, test, puncture site,sample source ** sample source **


PASSWORD PROTECTION 4-level security 4-level security Yes Yes

POWER REQUIREMENTS,VAC, Hz 100-240, 100-240, 100-240, AC85-264 V 50/60 Hz,

50/60 50/60 50/60 150 W, power failureprotection

POWER CONSUMPTION 160 VA 160 VA 110 VA 150 W

H x W x D, cm (in) 60 x 53 x 47 60 x 53 x 47 45.7 x 35.6 x 41 36.6 x 46.7 x 48.7(23.6 x 20.9 x 18.5) (23.6 x 20.9 x 18.5) (18 x 14 x 16.1) (14.4 x 18.4 x 19.2)

WEIGHT, kg (lb) 36 (79) 40 (88) 23 (50.7) 15 (33)

LIST PRICE $47,900 $55,900 $18,000 Not specified


OTHER SPECIFICATIONS Keyboard; random- Keyboard; random- Automatic sample No gas needed; zero-access test selec- access test selec- aspiration; clot and maintenancetivity; onboard help tivity; onboard help air detection; QC electrode; moviefunctions; sealed functions; sealed and user lockout; instruction; reagentwaste container; no waste container; no OMNILink remote and waste levelgases needed; up- gases needed; up- control; optional detection; onboardgradable to add gradable to add auto QC module with help function.future BUN; optional future BUN; optional 120 ampules.remote diagnostics remote diagnosticsvia modem; optional via modem; optionalAutoQC unit for AutoQC unit forautomatic QC automatic QCmeasurement and measurement andevaluation with auto evaluation with autoparameter lock/ parameter lock/unlock features. unlock features.Meets requirements Meets requirementsof CSA and OVE. of CSA and OVE.





MODEL TECHNO MEDICA TECHNO MEDICA TECHNO MEDICA

GASTAT-602i GASTAT-603ie GASTAT-mini

WHERE MARKETED Worldwide Worldwide Worldwide

FDA CLEARANCE No No No

CE MARK (MDD) Yes Yes Yes


BP, mm Hg 500-800 Torr 500-800 Torr NoCa++, mmol/L 0.5-5.0 0.5-5.0 0.25-2.5Hct, % 15-65 15-65 15-65K+, mmol/L 1.00-10.00 1.00-10.00 1.0-9.0Na+, mmol/L 80.0-200.0 80.0-200.0 100-180pH 6.000-8.000 6.000-8.000 6.0-8.0PCO2, mm Hg 10.0-200.0 10.0-200.0 10-200PO2, mm Hg 5.0-760 Torr 5.0-760 Torr 20-780

Others Cl- (50.0-200.0) Cl- (50.0-200.0), BUN (3-125 mg/dL)glucose, lactate

Deriveda/A No No NoA-aDO2 Yes Yes YesBE Yes Yes YesBEecf No No NoHb Yes Yes YesHCO3

- Yes Yes YesctO2 Yes Yes YesSB Yes Yes YesSO2 Yes Yes YesctCO2 Yes Yes YesOthers None specified None specified BB-BB

SO2 & ctO2 ON/OFF Yes Yes No

SAMPLE VOLUME, µLNormal 100 130 50-100

Micro 85 85 No

INTEGRAL MULTI-WAVELENGTH OXIMETER No No No

VISIBLE SAMPLECHAMBER Yes Yes Yes

ANALYSIS TIME, sec 60 60 180

ELECTRODEMAINTENANCE None None None

DISPLAY Full color back- Full color back- LCDlit display lit display

PRINTOUT Roll printer Roll printer Roll printer





MODEL TECHNO MEDICA TECHNO MEDICA TECHNO MEDICA

GASTAT-602i GASTAT-603ie GASTAT-mini

CALIBRATION Automatic, program- Automatic, program- Automatic, 1-pointmable 1- and 2-point mable 1- and 2-pointcalibration calibration

STANDBY MODE Yes Yes No

INTERFACE TCP/IP, RS232C TCP/IP, RS232C RS232C

DATA MANAGEMENT Yes Yes Yes

USER-ENTERED DATA Patient ID, patient Patient ID, patient Patient temp, Hb, BPtemp, Hb, FiO2, BP temp, Hb, FiO2, BP

BAR-CODE READER Yes Yes No

PASSWORD PROTECTION Yes Yes No

POWER REQUIREMENTS,VAC, Hz AC85-264 V 50/60 Hz, AC85-264 V 50/60 Hz, 110/120, 50/60;

150 W, power failure 150 W, power failure 4.8 V rechargeableprotection protection battery

POWER CONSUMPTION 150 W 150 W 30 W

H x W x D, cm (in) 36.6 x 46.7 x 48.7 36.6 x 46.7 x 48.7 5 x 21.5 x 10(14.4 x 18.4 x 19.2) (14.4 x 18.4 x 19.2) (2 x 8.5 x 3.9)

WEIGHT, kg (lb) 15 (33) 15 (33) 1.2 (2.6)

LIST PRICE Not specified Not specified Not specified

Warranty 1 year 1 year 1 year

OTHER SPECIFICATIONS No gas needed; zero- No gas needed; zero- Disposable sensormaintenance maintenance card with built-inelectrode; movie electrode; movie sensors and calibra-instruction; reagent instruction; reagent tion fluid; onboardand waste level and waste level printer.detection; onboard detection; onboardhelp function. help function.




blood gas/ph analyzers - amazon simple storage service · blood gas/ph analyzers ... values for po2...

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