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pH Advanced Technology for PCO2 Blood Gas and Critical Care Analyses PO2 SO2% Hct Hb + Na Stat Profile pHOx Basic pH PCO PO K+ Stat Profile pHOx Oximetry pH PCO PO SO % Hct Hb Profile pHOx Respiratory Ca++ Stat pH PCO PO SO % Hct Hb Lac Stat Profile pHOx Plus PO SO % Hct Hb Na K Ca Cl Glu Cl pHStat PCO Profile pHOx Plus C pH PCO PO SO % Hct Hb Na K Ca Cl Glu Profile pHOx Plus L Glu pHStat PCO PO SO % Hct Hb Na K Ca Cl Glu Lac Lac Stat Profile pHOx Series ® ® Blood Gas Profile 2 2 Blood Gas/Oximetry Profile 2 2 2 Blood Gas/Respiratory Profile 2 2 2 Critical Care Profile + 2 2 Critical Care Profile + 2 2 + 2 ++ - + ++ - + ++ - or 2 Critical Care Profile 2 + 2 2 or Six Models with Blood Gas and Critical Care Menus Using a unique combination of advanced optical and electrode technology, Stat Profile pHOx® analyzers offer blood gas or point-of-care (POC) test menus. The Stat Profile pHOx Basic test menu consists of pH, PCO2, and PO2. The other five pHOx menus include pH, PCO2, PO2 and add choices of measured hemoglobin, hematocrit, SO2%, glucose, lactate, sodium, potassium, calcium and chloride assays in the combinations shown in the table below. A unique technology feature of Nova Stat Profile analyzers is that they can measure hemoglobin, hematocrit and SO2% on each sample without the added cost and added sample volume of a CO-Oximeter. For many users, these basic oxygenation tests greatly reduce the number of separate COOximetry analyses that need to be done. However, when a full CO-Oximeter profile, including the hemoglobin fractions, is needed, a Stat Profile pHOx CO-Oximeter is available. pHOx Models/Menus Stat Profile pHOx Basic: pH PCO2 PO2 Stat Profile pHOx Oximetry: pH PCO2 PO2 SO2% Hct Hb Stat Profile pHOx Respiratory: pH PCO2 PO2 SO2% Hct Hb Lac Stat Profile pHOx Plus: pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Ca++ or Cl- Stat Profile pHOx Plus C: pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Ca++ and Cl- Stat Profile pHOx Plus L: pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Lac Ca++ or Cl- Advanced Analytics Microsensors New, smaller electrode designs create several improvements. A 45 microliter blood sample is offered for pediatric patients. New disposable sensor elements eliminate electrode maintenance. When a disposable element needs to be replaced, it can be done in seconds. Optics Oxygen saturation and hemoglobin are measured based upon advanced multi-wavelength optical reflectance technology. Measured vs. Calculated SO2%without CO-Oximeter Measured rather than calculated oxygen saturation (SO2%) is officially recognized by the National Committee for Clinical Laboratory Standards (NCCLS) as necessary for accurate assessment of oxygen saturation. The 1997 NCCLS Standard C-25A recommends that calculated SO2% values of blood gas analyzers not be used to assess a patientʼs oxygenation status because of the potential errors that can result.1 All models except the Stat Profile pHOx Basic provide measured SO2% without the need for a separate CO-Oximeter. Fast Stat Results Stat Profile pHOx analyzers process samples rapidly. All test results are available and are displayed on-screen in 45 seconds (pHOx Oximetry and pHOx Basic), 50 seconds (pHOx Plus), or 52 seconds (pHOx Plus C, pHOx Plus L, and pHOx Respiratory). Throughput rates are 50 samples per hour for pHOx Basic and pHOx Oximetry, 44 samples per hour for the pHOx Plus and pHOx Plus C, and 40 samples per hour for the pHOx Plus L and pHOx Respiratory. All Liquid Calibration Cartridge Eliminates Gas Tanks A new, liquid-only calibration cartridge eliminates bulky compressed gas tanks, gas regulators, gas tubing lines, and humidifiers. A single cartridge contains all calibrators. This integrated gas and reagent packaging system replaces up to five individual reagent bottles and two gas tanks with a simple, snap-in reagent cartridge. The single cartridge also eliminates the need to maintain logs and run both calibration and QC procedures each time one of the five individual reagent bottles or two gas tanks is replaced. When the calibration cartridge is used, all calibrator values, fluid volumes, and expiration dates are automatically downloaded to the computerized Reagent Management System (RMS). Fluid consumption is then automatically monitored and calibration reagent levels are displayed on-screen. In addition, the calibration cartridge includes a sealed waste container that stores the sample and reagent waste. The waste container is completely enclosed for safety and ease of disposal. On-Board Cartridge QC Automates Quality Control Novaʼs Auto-Cartridge QC is a totally automated quality control system contained within a single on-board control cartridge. This unique system combines multiple levels of controls and dedicated software allowing any level of quality control to be run at any time, either on a preprogrammed schedule or on demand. Small Sample Volume Blood conservation is an important initiative in every critical care department, especially the NICU. The average daily blood loss due to laboratory tests in critically ill patients is 25 to 125 mL/day per patient.2,3,4 Stat Profile pHOx analyzer sample volumes are important contributors to blood conservation with volumes as low as 45 µL for blood gas and only 125 µL for a full 11 test menu. Full Panel Stat Profile pHOx Basic 70 µL (3 tests) Micro Panel (pH, PCO2, PO2) 45 µL (3 tests) Stat Profile pHOx Oximetry 70 µL (6 tests) 45 µL (3 tests) Stat Profile 125 µL pHOx Respiratory (7 tests) 60 µL (3 tests) Stat Profile pHOx Plus 115 µL (10 tests) 55 µL (3 tests) Stat Profile pHOx Plus C 125 µL (11 tests) 60 µL (3 tests) Stat Profile pHOx Plus L 125 µL (11 tests) 60 µL (3 tests) Time and Labor Savings For most users, analyzing controls and entering quality control data require more time and labor than any other aspect of blood gas testing. The AutoCartridge QC system dramatically reduces costs by eliminating the time and labor required to manually perform quality control. Each Nova Auto-Cartridge contains three levels of blood chemistry controls, two levels of SO2%, hematocrit and hemoglobin controls, and software which automates running controls and storing quality control data. When the cartridge is installed, all quality control target ranges, lot code, and expiration date are automatically downloaded to the analyzer. Automatic QC Analysis The user can program the analyzer to automatically analyze up to three quality control levels, three times per day. Auto Repeat and Flagging If any analyte value is outside the target range, it is automatically reanalyzed; if a control value remains outside of range, the user is notified. Automatic Data Storage and Reporting All quality control data is automatically stored. Daily and cumulative statistical reports and Levey-Jennings graphs can be printed at any time. This automation not only eliminates labor, it assures that quality control is always performed accurately and on schedule, and guarantees regulatory compliance. Automated Activation from Standby If the analyzer is put into standby mode for several hours or days, it can be programmed to automatically restart, calibrate itself, and perform QC at a pre-selected time and date. QC Lockout An optional QC lockout feature programs the analyzer to suppress test results for any analyte that is not within its control range. Compact POC Design Stat Profile pHOx analyzers are the smallest instruments offering their respective test menus. The analyzer footprint is only 12” wide by 15” deep by 15” tall (31 cm x 38 cm x 38 cm), including on-board reagents and controls, and a sealed waste container to store used reagents and samples. These analyzers weigh less than 20 pounds (9 kg) and are easily transported on the optional pHOx Cart with an uninterruptible power manager. Easy, Safe Capillary or Syringe Use The Stat Profile pHOx sampler is designed for fast, easy use and operator safety. For samples in syringes, the sampler probe automatically positions itself at the optimal angle. For capillary samples, the sampler automatically presents a universal capillary sampling port in a horizontal position to prevent spillage or dripping. As sampling is performed directly from the capillary, no adapter or sample transfer is required. This assures that sample integrity and operator safety are optimized. Following sample aspiration from either syringes or capillaries, the sampler moves to an internal wash position and is automatically cleaned. Benefits for the Physician, Laboratory, and Management For the Physician: Improved Diagnosis • Comprehensive diagnosis of patient acid/base oxygenation status plus key electrolyte, metabolite and hematology parameters. • Small sample size for pediatric patients. • 52 second stat analysis time for the full 11 test panel. For the Laboratory: Time and Labor Savings • On-board QC system eliminates running controls and entering data. • Eliminating bulky gas tanks, regulators, humidifiers, and tubing lines avoids ongoing replacement and maintenance. • Single calibration cartridge eliminates labor required to replace consumable items and perform separate recalibrations and QC procedures. • Sealed on-board waste container with enclosed biocide can be disposed without operator contact to blood waste. • Disposable sensor elements require no daily maintenance, have long operating lives, and can be replaced in seconds. For Management: Real Cost Savings • On-board QC ensures quality control, and eliminates 80% of the daily labor required to perform quality controls. • Advanced microsensors, surface mount electronics, and reagent packaging significantly reduce analyzer cost and reagent consumption. • Elimination of sensor maintenance, gas tank replacement, emptying and cleaning waste containers, cleaning gas lines, regulators, and humidifiers substantially reduces operating labor and inventory costs. • Enhanced clinician satisfaction due to rapid turnaround of key diagnostic information. A Complete POC Connectivity Solution Any number of Nova analyzers can be interfaced with Novaʼs powerful Point-of-Care Data Manager (PDM) software. This connectivity software provides a flexible, integrated POC system performing these key functions: Process Automation PDM automates the order entry, accessioning, and reporting process. This process automation software reduces turnaround time, eliminates manual order entry and data reporting, prevents data errors, and improves efficiency of operation. Remote Control The lab can remotely view instrument status and initiate an automated analyzer calibration, maintenance cycle, or on-board QC testing for a POC analyzer. It also can restrict analyzer use by password access, and permit the lab to enable or disable any test channel on the analyzer. Remote Review PDM enables the central laboratory to have a constant overview of POC analyzers located at the point-of-care. Laboratory staff can review, verify, edit, store, and print POC test results, quality control, and instrument calibration without ever leaving the laboratory. Data Capture PDM captures data from multiple analyzers and connects with the LIS and HIS for seamless integration of data. PDM is the gateway to an open system allowing connectivity of instruments from other POC vendors. The HL7 data format used by the PDM allows for universal connectivity to any LIS system. Password Protection All pHOx analyzers accept up to 200 individual passwords with multiple privilege levels, thereby restricting access to authorized individuals only. Further, a test suppression function permits the lab to enable or disable any test channel on the analyzer. Point-of-Care Data Manager (PDM) POC Analyzer Laboratory, respiratory or point-of-care locations Point-of-Care Data Manager Controls any number of analyzers HIS LIS Laboratory and Hospital Information Systems Stat Profile pHOx Series Specifications Measured Tests Methodology Na+ ............................. Direct ISE K+ ............................... Direct ISE Ca++ ............................. Direct ISE Glucose......................... Enzyme/Amperometric Lactate.......................... Enzyme/Amperometric Cl- ................................ Direct ISE pH ................................ Direct ISE PCO2 .......................... Severinghaus PO2 ............................... Amperometric SO2% ............................ Optical, reflectance Hematocrit .................. Conductivity/Na+ correction Hemoglobin ................. Multi-wavelength reflectance/ conductivity correction Calculated: TestsResolution Tests Resolution 0.1 mmol/L a/A 0.1 HCO3 TCO2 0.1 mmol/L PO2/FIO2 0.1 Be-ecf 0.1 mmol/L Anion Gap 0.1 mmol/L B-eb 0.1 mmol/L SBC 0.1 mmol/L O2Ct 0.1 mL/dL (1 mL/L) A 0.1 mmHg (0.01 kPa) A-aDO2 0.1 mmHg (0.01 kPa) Special Calculated Tests (CO-Oximeter Required): Tests Resolution Qsp/Qt 0.1 A-v DO2 0.1 mmHg (0.01 kPa) CaO2 0.1 mmHg (0.01 kPa) CcO2 0.1 mmHg (0.01 kPa) P50 0.1 mmHg (0.01 kPa) Measurement Range: Na+ 80 - 200 mmol/L K+ 1 - 20 mmol/L Ca++ 0.1 - 2.7 mmol/L Glu 15 - 500 mg/dL Lac 0.3 - 20 mmol/L 50 - 200 mmol/L ClpH 6.50 - 8.00 (H+: 316.23 - 10.00 mmol/L) PCO2 3.0 - 200 mmHg (0.4 - 26.7 kPa) PO2 0 - 800 mmHg (0.0 - 106.7 kPa) SO2% 30 - 100 % (0.3 - 1.00) Hb 4.0 - 24.0 g/dL (2.5 - 14.9 mmol/L) Hct 12% - 70% (12 - 60% for micro in Plus family and pHOx Respiratory) BarP 400.0 - 800.0 mmHg (53.3 -106.7 kPa) Major Features: 1/4 VGA color display (color available 6/1/05)- multilingual, visible flow path, automatic QC, QC statistics reports, LeveyJennings plots, gasless calibration (no tanks or regulators), automatic sampler, integral capillary adapter, PCMCIA type program changer, optional CCD bar code scanner, single snap-in reagent system, arterial venous physiological shunt mode, QC data storage, combined CO-Oximetry and blood gas results, ventilator settings, draw puncture site Certifications: ISO 9001 Quality System Registration, CSA, TÜV, CE Self Declared Complies to EN 61010, EN 50081,82 Physical Specifications: Height: 15.0 in (38.1 cm) Width: 12.0 in (30.5 cm) Depth: 15.0 in (38.1 cm) Weight: 18 lb (8.19 kg) without reagent pack Analytical Specifications for Imprecision (Normal Aspiration Mode): Within-Run Imprecision Day-to-Day Imprecision n=20 Whichever is Greater n=20 Whichever is Greater Analyte CV% SD CV% SD 1.0 1.0 (mmol/L) 1.5 1.0 (mmol/L) Na+ K+ 1.5 0.15 (mmol/L) 3.0 0.15 (mmol/L) 2.0 0.05 (mmol/L) 4.0 0.05 (mmol/L) Ca++ Glucose 5.0 2.0 (mmol/L) 6.5 3.0 (mmol/L) Lactate 3.0 0.3 (mmol/L) 6.0 3.0 (mmol/L) 1.5 2.0 (mmol/L) 2.5 2.0 (mmol/L) ClN/A 1.0 % N/A 1.5 % SO2% 3.0 1.0 (mmHg) 5.0 2.0 (mmHg) PCO2 PO2 (< 400 mmHg) 3.0 1.5 (mmHg) 5.0 3.0 (mmHg) – 10.0 – PO2 (> 400 mmHg) 6.0 Hct N/A 1.0 % N/A 1.0 Hct% pH N/A 0.005 N/A 0.013 Hb 2.5 0.3 g/dL 2.5 0.3 g/dL Acceptable Samples: Whole blood (heparinized), arterial, mixed venous, capillary, serum plasma (pHOx Plus L only) Analysis Rate: Stat Analysis Time Throughput Rate pHOx Basic 45 seconds 50/hour pHOx Oximetry 45 seconds 50/hour pHOx Respiratory 52 seconds 40/hour pHOx Plus 50 seconds 44/hour pHOx Plus C 52 seconds 44/hour pHOx Plus L 52 seconds 40/hour Sample Volume pHOx Basic: 45 microliters whole blood micro sample for pH/PCO2/PO2 70 microliters whole blood sample size for full panel Sample Volume pHOx Oximetry: 45 microliters whole blood micro sample for blood gases/pH 70 microliters whole blood sample size for full panel Sample Volume pHOx Respiratory: 60 microliters whole blood micro sample for blood gases/pH 125 microliters whole blood sample size for full panel Sample Volume pHOx Plus: 55 microliters whole blood micro sample for blood gases/pH 115 microliters whole blood sample size for full panel Sample Volume pHOx Plus C and pHOx Plus L: 60 microliters whole blood micro sample for blood gases/pH 125 microliters whole blood sample size for 11 test panel Electrical Requirements: 90-264 VAC, 50/60 Hz, 200W Interfaces: RS232 serial, ASTM Standard data protocol Temperature Thermostatting: 37°C ± 0.1°C Printer: 52 Column thermal — Built in FDA Labeling: For in-vitro diagnostic use Calibration: User-selectable, fully automatic two-point calibration every 2, 4, or 6 hours; user-selectable, single-point calibration every 30/45 minutes or with each sample (pHOx Plus and pHOx Plus L are fixed at 30 minutes or with each sample); manual calibration initiated at any time. NOVA BIOMEDICAL HEADQUARTERS 200 Prospect Street, Waltham, MA 02454-9141 U.S.A. TEL: (781) 894-0800 (800) 458-5813 FAX: (781) 894-5915 NOVA BIOMEDICAL AUSTRIA Laxenburgerstrasse 33/6, 1100 Vienna, Austria TEL: (43) 1-603 09 700 FAX: (43) 1-603 09 702 NOVA BIOMEDICAL CANADA, LTD 6810 Kitimat Road, Unit 5, Mississauga, Ontario L5N 5M2 Canada TEL: (905) 567-7700 (800) 263-5999 FAX: (905) 567-5496 NOVA BIOMEDICAL FRANCE Z.I. de Courtaboeuf, 15 Avenue du Quebec, B.P. 632, 91965 Les Ulis Cedex, France TEL: (33) 1-69188140 FAX: (33) 1-69070160 NOVA BIOMEDICAL GmbH Adam-Opel-Str. 19 A, D 63322 Rödermark, F.R. Germany TEL: (49) 6074-8448-0 FAX: (49) 6074-844833 e-mail: [email protected] NOVA BIOMEDICAL INDIA 117C, Sector-2, Pocket-2, Dwarka, New Delhi 110075 India TEL: +91 11 2508 9217 +91 11 2508 2664 FAX: +91 11 2508 9018 e-mail: [email protected] NOVA BIOMEDICAL K.K. B-3F Omori Bellport, 26-MinamiOi 6-chome, Shinagawa-ku, Tokyo 140-0013, Japan TEL: (03) 5471-5461 FAX: (03) 5471-5474 e-mail: [email protected] NOVA BIOMEDICAL U.K. C3-5, Evans Business Centre, Deeside Industrial Park, Deeside, Flintshire CH5 2JZ United Kingdom TEL: (44) 1244 287087 FAX: (44) 1244 287080 e-mail: offi[email protected] IN THE U.S., call toll-free 800-458-5813 IN CANADA, call toll-free 800-263-5999 Internet address: www.novabiomedical.com e-mail: [email protected] Stat Profile pHOx Series Co-Oximeter Specifications Test Menu: COHb, carboxyhemoglobin; HHb, deoxyhemoglobin; O 2 Hb, oxyhemoglobin; MetHb, methemoglobin; tHb, total hemoglobin; SO2%, oxygen saturation; O2Ct, oxygen content; O2Cap, oxygen capacity Monitored Interferences: SulfHb, sulfhemoglobin (Measured; user alerted if abnormal, > 1.5%) Sample Volume: 115 µL Cycle Time: 80 seconds Samples/Hour: 45 Sample Type: Heparinized whole blood Operating Ranges: COHb ..........0 to 100 % HHb............0 to 100 % O2Hb............0 to 100 % MetHb ........0 to 100 % SO2% ...........0 to 100 % O2Ct............0 to 40.3 vol% O2Cap..........0 to 40.3 vol% tHb..............5 to 30 g/dL sHb..............Alert > 1.5% Physical Specifications: Height 15.0 in (38.1 cm) Width 12.0 in (30.5 cm) Depth 15.0 in (38.1 cm) Weight: 18 lb (8.19 kg) without reagent pack Electrical Power Requirements: 90-264 VAC, 50/60 Hz Data Ports: 2 bidirectional serial I/O data ports, 1 printer port 1 port for optional external bar code reader Printer Options: External, 8-1/2” x 11” dot matrix External thermal roll printer Display Languages (user selectable): English, French, German, Italian, Japanese, and Spanish Optical System: Spectrophotometer Wavelengths Measured: 557, 577, 597, 605, 624, 635, 650 nm Light Source: Halogen Expected Light Source Use Life: 50,000 Hours (5+ Years) Cuvette Temperature Control: 37°C ± 0.5°C Certifications: ISO 9001 Quality System Registration, CSA, TÜV, CE Self Declared Complies to EN 61010, EN 50081,82 References National Committee for Clinical Laboratory Standards. Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement and Reporting. Villanova, PA: NCCLS; 1997. 2 Excessive Blood Drawing for Laboratory Tests. Hicks, J.M., The New England Journal of Medicine, May 27, 1999;1690. 3 Evaluation of a new blood-conserving arterial line system for patients in intensive care units. Silver, M.J., Juhran, H., Stein, S., et al. Critical Care Medicine, 1993; 21, 507-511. 4 Blood conservation in critical care: the evidence accumulates. Chernow, B. Critical Care Medicine, 1993; 21, 481-482. 1 Specifications are subject to change without notice. No. 85 3/06