NOVA BIOMEDICAL Stat Profile PRIME Instructions For Use Manual
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NOVA BIOMEDICAL Stat Profile PRIME Instructions For Use Manual

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Stat Profile® PRIME™
CCS Analyzer
Instructions for
Use Manual

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Summary of Contents for NOVA BIOMEDICAL Stat Profile PRIME

  • Page 1 52920 Stat Profile® PRIME™ CCS Analyzer Instructions for Use Manual...
  • Page 3 Nova Prime Quick Start Guide Confirm the analyzer is Ready for analysis. Displays Ready, desired test menu shows no Orange Icons. Login if necessary. Press the Login icon then enter or scan your User ID and Password. Select the Sample Container and the Panel. Prepare the sample for analysis then press extend the sample probe.
  • Page 5 Nova Biomedical SymBol directory In vitro diagnostic medical device Batch code Product fulfills the requirements of Directive Serial Number 98/79 EC (IVDD) Caution, consult accompanying documents Temperature limitation Upper Limit of Temperature Consult instructions for use Use by (last day of the month)
  • Page 7 Cheshire, WA7 3FY, UK Trademark and Patents Stat Profile is a registered Trademark of Nova Biomedical Corporation. Stat Profile Prime is a Trademark of Nova Biomedical Corporation. Copyright Printed in the U.S.A. Copyright 2013, Nova Biomedical Corporation, Waltham, MA 02454-9141...
  • Page 8 U.S.A.: 1-800-545-NOVA 1-781-894-0800 FAX: 1-781-894-0585 For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. Nova Biomedical GmbH Nova Biomedical Canada Ltd. Messenhauser Str. 42 17 - 2900 Argentia Road Roedermark Mississauga, Ontario L5N 7X9...

  • Page 9: Table Of Contents

    Table of Contents Introduction 1.1 About This Manual ...........1-1 1.2 Safety ...............1-1 1.3 Installation and Use ..........1-4 1.4 Requirements ............1-4 1.5 Intended Use, Tests Performed, and Clinical Utility .1-5 1.6 The Sample .............1-8 1.6.1 Handling Requirements......... 1-8 1.6.2 Acceptable Anticoagulants ......1-9 Getting Started 2.1 Power Up Procedure ..........2-3 2.2 The Home Screen: Ready ........2-4...
  • Page 10 Prime CCS Instructions for Use Manual Periodic Replacements 5.1 Pump Tubing Replacement ........5-1 5.2 Probe Replacement ..........5-3 5.2 Reference Sensor Replacement......5-5 5.3 Printer Paper Replacement ........5-7 5.4 Safety Sample Port Replacement......5-8 Troubleshooting 6.1 Troubleshooting Procedures ........6-1 6.2 Error Log ..............6-2 6.3 Operator Flow Test ..........6-2 6.3.1 Flushing the Reference Sensor.....

  • Page 11: Introduction

    1 Introduction 1 Introduction This manual provides all necessary instructions for the routine operation and upkeep of all Stat Profile Prime CCS Analyzer. Please read this manual carefully. It has been prepared to help you attain optimum performance from your Analyzer.
  • Page 12 Prime CCS Instructions for Use Manual General Safety 1. Read the safety and operating instructions before operating the analyzer. 2. Retain the safety and operating instructions for future reference. 3. Observe all warnings on the analyzer and in the operating instructions. 4.
  • Page 13 2. This device must accept any interference received, Including interference that may cause undesired operation Changes and Modifications not expressly approved by Nova Biomedical Corporation can void your authority to operate this equipment under Federal Communications Commissions rules. Radio Standards Specifications (RSS) Notice This device complies with Industry Canada licence-exempt RSS standard(s).

  • Page 14: Installation And Use

    1.3 Installation and Use This section covers the installation requirements and assembly procedures for the Stat Profile Prime CCS Analyzer. Prior to use of the analyzer, operators should be familiar with Chapter 2 Operation and Chapter 3 Operating Procedures.

  • Page 15: Intended Use, Tests Performed, And Clinical Utility

    4. Place the analyzer onto a clean and flat surface. 1.5 Intended Use, Tests Performed, and Clinical Utility Intended Use The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination...
  • Page 16 Prime CCS Instructions for Use Manual Calculated Parameters From the directly measured results, the calculated results are shown in Table 1-1 for each analyzer in the Stat Profile Prime CCS. Table 1-1. Calculated Parameters Calculated Parameters pH, PCO , PO (corrected to patient temperature) Bicarbonate level (HCO Total Carbon Dioxide (TCO...
  • Page 17 1 Introduction Clinical Utility The following list includes the clinical utility information for each of the analytes measured on the Stat Profile Prime CCS Analyzer. , Whole blood measurement of blood gases is used in the diagnosis and treatment of life-threatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases.

  • Page 18: The Sample

    1.6 The Sample Sodium or lithium heparin whole blood samples from syringes, open tubes, small cups, and capillary tubes can be used on the Stat Profile Prime CCS Analyzer. The minimum sample size for analysis is 100 µL. 1.6.1 Handling Requirements Correct sample handling is critical to ensure that the blood gas values obtained accurately reflect the in vivo state.

  • Page 19: Acceptable Anticoagulants

    Our experience suggests that lyophilized lithium heparin giving a final concentration in blood of not more than 20 I.U. per mL is acceptable. CAUTION: Stat Profile Prime CCS Analyzer users should take careful note of these considerations when establishing reference intervals and...
  • Page 20 Prime CCS Instructions for Use Manual 1-10...

  • Page 21: Getting Started

    2 Getting Started 2 Getting Started The Stat Profile Prime CCS Analyzer is pictured below. Figure 2.1 Nova Stat Profile Prime CCS Touch-screen Display Printer Sampler Door/Front Panel...
  • Page 22 Prime CCS Instructions for Use Manual Figure 2.2 Analytical Compartment 1. Waste Line 2. Reference Line 3. Pump and Pump Tubing 4. Calibrator Cartridge Opening 5. Control Cartridge Opening 6. Sampler 7. Air Detector 8. Sensor Card (under cover) 9. Reference Sensor (under cover)

  • Page 23: Power Up Procedure

    2 Getting Started 2.1 Power Up Procedure When the analyzer is powered on, it displays the Nova Prime CCS logo. During this time, an internal Power On Self Test (POST) is run. Any errors encountered during the POST will display on the analyzer's screen. After successfully completing the POST, the Home screen displays with Initializing.

  • Page 24: The Home Screen: Ready

    Prime CCS Instructions for Use Manual 2.2 The Home Screen: Ready Header Bar Selection Area Menu Bar Figure 2.5 Home Screen: Ready The screen of the Prime CCS Analyzer is a Touch-screen. The touch-screen display provides prompts, menus, status information, sensor status, panel selection, date and time, etc. 2.2.1 Header Bar The Header Bar is the top section of the display.

  • Page 25: Selection Area

    2 Getting Started • The analyzer can also be run with the login featured turned off. The upper right corner of the Home screen (Header Bar) has the Status Graph which when touched will display the status of the Sensor Card, calibrator cartridge, and QC cartridge.

  • Page 26: Menu Bar

    Prime CCS Instructions for Use Manual 2.2.3 Menu Bar The Menu Bar is the bottom section of the screen. The Tool Box icon (System Menu screens), Find Results icon, QC icon (to run QC and QC Menu Screens), and the Start (Run Test) or Calibrate icon.

  • Page 27: Automatic Calibrations

    2 Getting Started 2.3 Automatic Calibrations The Stat Profile Prime CCS analyzer performs a 2-point calibration on all analytes and air detectors 30 minutes after being powered on and regularly thereafter to maintain optimal sensor card and air detector performance. A 1-point calibration is performed at regular intervals to monitor the sensor card’s performance between each 2-point calibration.

  • Page 28: Manual Calibrations

    Prime CCS Instructions for Use Manual 2.3.1 Manual Calibrations A manually initiated 2-point calibration can be performed whenever the analyzer displays Ready or Not Ready on the header bar. A Not Ready (Not Calibrated) status is displayed after powering the analyzer on, after replacing some consumable items or as a result of a system error.

  • Page 29: Sample Analysis

    3 Sample Analysis 3 Sample Analysis When Ready is displayed on the Home screen the analyzer is ready to analyze samples for any analyte not displaying Orange test button. The analyzer can measure whole blood samples from capillary tubes, syringes, test tubes, and open containers as well as external Quality Control material from ampules and internal Quality Control material from an internal QC cartridge...
  • Page 30 Prime CCS Instructions for Use Manual 2. Select the desired Test Panel from the drop-down list or select one or more analytes to create a Custom Panel. Figure 3.2 Ready Screen: Container and Panel Drop-down List 3. Press Start icon to begin the analysis. 4.

  • Page 31: Utilizing The Luer Station

    3 Sample Analysis 6. Enter any Required or Optional information while the analysis is running. NOTE: The sample will remain on screen until all Required fields have been entered. The analysis can be cancelled by pressing the X icon but results will not be printed or transmitted.
  • Page 32 Prime CCS Instructions for Use Manual Figure 3.6 Operator ID Screen and Operator Password Screen If login is not required or after logging into the analyzer: 1. Select the syringe icon from the container drop-down list. 2. Select the desired Test Panel from the drop-down list or select one or more analytes to create a Custom Panel.
  • Page 33 3 Sample Analysis 4. Press Start icon to begin the analysis. Figure 3.8 Syringe Sample with Luer 5. If prompted, enter a l l R e q u i r e d I n f o r m a t i o n and press Start o n c e...
  • Page 34 Prime CCS Instructions for Use Manual NOTE: The sample will remain on screen until all Required fields have been entered. The analysis can be cancelled by pressing the X icon but results will not be printed or transmitted. 3.1.3 Analyzing Sample from a Blood Collection Tube From the Home screen, login if you are prompted to login.
  • Page 35 3 Sample Analysis Figure 3.12 Ready Screen: Container and Panel Drop-down List 3. Press Start icon to begin the analysis. 4. If prompted, enter a l l R e q u i r e d I n f o r m a t i o n and press Start o n c e more to begin the...
  • Page 36 Prime CCS Instructions for Use Manual 6. Enter any Required or Optional information while the analysis is running. NOTE: The sample will remain on screen until all Required fields have been entered. analysis can be cancelled pressing the X icon but results will not be printed or transmitted.
  • Page 37 3 Sample Analysis 2. Select the desired Test Panel from the drop-down list or select one or more analytes to create a Custom Panel. Figure 3.17 Ready Screen: Container and Panel Drop-down List 3. Press Start icon to begin the analysis. 4.

  • Page 38: The Sample Results Display

    Prime CCS Instructions for Use Manual 6. When prompted, remove the capillary tube and press Continue. 7. Enter any Required or Optional information while the analysis is running. NOTE: The sample will remain on screen until all Required fields have been entered. The analysis can be cancelled by pressing the X icon...
  • Page 39 3 Sample Analysis The last (right hand) section indicates the sample result is higher than the entered normal range. • The segment is displayed with a Orange background if a sample result is between the high Normal and high Alert range. •...

  • Page 40: Analyzing Qc And Proficiency Samples

    Prime CCS Instructions for Use Manual 3.3 Analyzing QC and Proficiency Samples Before running a QC sample verify the analyzer is Ready to perform the analysis and that all the desired analytes are available for selection. If necessary, refer to Chapter 2 for additional information.
  • Page 41 3 Sample Analysis 3. From the drop-down list select the Internal Control Level to be analyzed. 4. Enter a QC comment if desired. 5. Press Start to begin the analysis. 6. Once the analysis is complete press Save to keep the QC results or press Delete to discard the QC results.
  • Page 42 Prime CCS Instructions for Use Manual 3.2.2 Analyzing External Quality Control Samples From the Home screen, login if you are prompted to login. 1. Press the Login icon to log into the analyzer. 2. Enter or scan your Operator ID then press 3.

  • Page 43: Analyzing Proficiency Samples

    3 Sample Analysis 6. Press Start to begin the analysis. 7. Wait for the Sample Probe to fully extend. 8. Prepare the sample for analysis (mix well) then position the sample o v e r t h e p r o b e and press Aspirate .
  • Page 44 Prime CCS Instructions for Use Manual If login is not required or after logging into the analyzer: 1. From the Home Screen, press the QC button 2. Press the Analyze QC button Figure 3.26 Quality Control Screens 3. From the drop-down list select the Proficiency. 4.

  • Page 45: Consumable Replacements

    4 Consumable Replacements The following sections provide detailed information and directions to operate and to maintain the Stat Profile Prime CCS Analyzer at peak efficiency. From the Home screen, press the Tool box icon. From these 2 screens, the following consumable replacements can be performed: •...

  • Page 46: Calibrator Cartridge & Control Cartridge Changing

    Prime CCS Instructions for Use Manual Figure 4.2 Screen 2 System Menu 4.2 Calibrator Cartridge and Control Cartridge Changing The reagent calibrator and/or control cartridge should be changed when the system indicates the cartridge is empty. From the Home screen, press the Tool Box icon. Then press Change Calibrator Cartridge or Change Control Cartridge.

  • Page 47: Change Calibrator Cartridge

    4 Consumable Replacements NOTE: The capillary adapter comes in the calibrator cartridge box. It is very important for the proper operation of the analyzer that the capillary adapter be changed with every calibrator cartridge change. Figure 4.3 Replacing Calibrator Cartridge and Control Cartridge 4.2.1 Change Calibrator Cartridge 1.

  • Page 48: Change Control Cartridge

    Prime CCS Instructions for Use Manual 4.2.2 Change Control Cartridge 1. Press the Tool Box icon. 2. From the System Menu, press the Change Control Cartridge and wait for pump to stop. 3. Open the door, remove old cartridge. Slide new cartridge in past the front retaining lip. 5.

  • Page 49: Periodic Replacements

    5 Periodic Replacements 5 Periodic Replacements Periodically the pump tubing or probe may may need to be replaced; the Reference Sensor has run out of use-life; and the printer needs a new roll of paper. This chapter gives detailed procedures on replacements of these consumable Items. 5.1 Pump Tubing Replacement The pump tubing should be replaced at intervals prescribed in the maintenance log.
  • Page 50 Prime CCS Instructions for Use Manual Figure 5.2 Release Pump Tubing Pressure Plate 3. Disconnect the Waste-line and Reference-line above the pump. 4. Disconnect the pump tubing manifold from the Reference Sensor. Figure 5.3 Disconnect Pump Manifold 5. Slide the pump tubing out by holding the tab of the tubing clip.

  • Page 51: Probe Replacement

    5 Periodic Replacements 5.2 Probe Replacement If the probe or air detector becomes damaged, replace it. Use the following procedure when replacing the probe or the air detector. 1. From the Home screen, press the Tool Box icon. From the System Menu select Replace Probe and wait for pump to stop.
  • Page 52 Prime CCS Instructions for Use Manual 5. Pinch together the white probe holder and remove the probe together with the S-line and air detector cable and discard. Pinch Clamp S-Line with Connection to Reference Sensor Cable of Air Detector to Analyzer Figure 5.7 Removing Probe, S-line, and Cable of Air Detector 6.

  • Page 53: Reference Sensor Replacement

    5 Periodic Replacements 5.2 Reference Sensor Replacement 1. From the Home screen, press the Tool Box icon. 2. From the System Menu select the Change Reference Sensor and wait for the pump to stop. 3. Open the door; open Cartridge door. Remove Sensor Card.
  • Page 54 Prime CCS Instructions for Use Manual 5. Unplug pump tubing manifold from top of sensor. 6. Disconnect the S-line from the bottom of the sensor using the removal tool attached to the door. 7. Use the Sensor Arm on the left of the sensor to push the sensor to the right and off.

  • Page 55: Printer Paper Replacement

    5 Periodic Replacements 5.3 Printer Paper Replacement 1. Open the printer cover. 2. Remove the depleted roll of paper. 3. Insert a new roll of paper. The loose end of the paper should feed from the bottom of the roll. 4.

  • Page 56: Safety Sample Port Replacement

    Prime CCS Instructions for Use Manual 5.4 Safety Sample Port Replacement 1. Open the door. 2. Slide out the old Safety Sample Port. 3. Slide in a new Safety Sample Port. 4. Close the door. Docking Station (Safety Sample Port) Slides Out Figure 5.11 Replacing the Safety Sample Port...

  • Page 57: Troubleshooting

    6 Troubleshooting 6 Troubleshooting This section describes the status screens and error codes, and explains the troubleshooting procedures for the Stat Profile Prime CCS Analyzer. WARNING: Blood samples and blood products are potential sources of infectious agents. Handle all blood products and flow path components (waste-line, capillary adapter, probe, sensor cartridge, etc.) with care.

  • Page 58: Error Log

    Next Page or Previous Page. To print the error log, select Printer Menu from the Service Menu. Table 6.1 lists the analyzer’s error logs and the corrective action. Table 6.1 Stat Profile Prime Error Logs Error Corrective Action To Be Determined 6.3 Operator Flow Test...

  • Page 59: Flushing The Sensor Cartridge

    Appendix A 7. Use the sensor arm on the left of the sensor to push the sensor to the right and off. 8. Use a syringe filled with distilled water and a tube to attach to the S-line port. 9. Push the distilled water through the bottom of the Reference Sensor.

  • Page 60: Flushing The Sample Probe

    Prime CCS Instructions for Use Manual 6.3.3 Flushing the Sample Probe 1. From the Home screen, press the Tool Box icon. From the System Menu select Replace Probe and wait for pump to stop. 2. Disconnect the air detector's sample line from the Reference Sensor module using the removal tool attached to the door.

  • Page 61: A Appendix

    Appendix A A Appendix Appendix A includes analyzer specifications, performance data, solutions and reagents, consumable lists, reference information, and warranty for the Stat Profile Prime CCS Analyzer. A.1 Specifications Measurement Range: 6.500 - 8.000 3.0 - 200 mmHg 0.4 - 26.7 kPa 0 - 800 mmHg 0.0 - 106.7 kPa...
  • Page 62 Prime CCS Instructions for Use Manual Resolution Calculated Result: – 0.1 mmol/L 0.1 mmol/L 0.10 mmol/L BE-ecf 0.1 mmol/L BE-b 0.1 mmol/L 0.1 mmol/L 0.1 mL/dL 0.1 mmHg 0.1 kPa With entered FiO 0.1 mmHg 0.1 kPa AaDO 0.1 mmHg 0.1 kPa 0.1 mmHg 0.1 kPa...

  • Page 63: Analytical Specificity

    Appendix A A.1.1 Analytical Specificity An interference study was performed according to CLSI guideline EP7-A2. The study used spiked and diluted specimens containing potential interfering substances for pH, PO , PCO , Na, K, iCa, Cl, glucose and lactate at normal physiological levels.
  • Page 64 Prime CCS Instructions for Use Manual Interfering Highest Analyte(s) Substance Concentration Tested Tested Glucosamine 30.0 µmol/L Heparin 100 IU/mL Glu, Lac Hydroxyurea 0.8 mg/dL Ibuprofen 2,425 µmol/L Glu, Lac pH, PCO , PO , Na, Intralipid 0.1% K, Cl, iCa, Glu, Lac Lithium Lactate 25.0 mmol/L Na, K, iCa, Glu...

  • Page 65: Analytical Performance Studies

    The protocol consisted of within run precision runs, day-to-day precision runs, linearity validation, and method comparison studies comparing the performance of the Stat Profile Prime CCS Analyzers to the Stat Profile pHOx Ultra Analyzers. Method Comparison Study...
  • Page 66 Stat Profile Prime CCS analyzer and then immediately run as a syringe specimen on the same Stat Profile Prime CCS analyzer. The capillary test result was compared to the syringe test result from each test system.
  • Page 67 Appendix A...
  • Page 68 Prime CCS Instructions for Use Manual...
  • Page 69 Appendix A...
  • Page 70 Prime CCS Instructions for Use Manual A-10...
  • Page 71 Appendix A A-11...
  • Page 72 Prime CCS Instructions for Use Manual Syringe Method Comparison Study Results vs. Stat Profile pHOx Ultra Test total # # altered specimen Analyzer Slope Intercept Parameter specimens specimens range 6.523 - 7.862 0.9976 0.0099 0.9985 6.519 - 7.875 0.9977 0.0106 0.9990 6.520 - 7.953 1.0018 -0.0225 0.9989 3.4 - 200.0 0.9854 0.9344 0.9977 3.1 - 192.6 1.0091 0.1547 0.9920...
  • Page 73 Appendix A Syringe Method Comparison Study Results Individual Analyzer Performance Data Capillary vs. Syringe Comparison Total # specimen Parameter Analyzer Slope Intercept specimens range 6.787 - 7.683 1.0094 -0.0721 0.9988 pH units 6.820 - 7.669 1.0157 -0.1176 0.9986 6.806 - 7.668 1.0097 -0.0714 0.9989...
  • Page 74 Within Run Precision Performance The protocol consisted of 20 replicates per run for each QC level on each of 3 Stat Profile Prime CCS Analyzers. The average, SD, CV%, and N for each analyzer for each QC level and parameter was calculated. The pooled average, SD, CV%, and N from all 3 analyzers for each QC level and parameter was calculated.
  • Page 75 Appendix A Stat Profile Prime Quality Control Level 1 Parameter n = 20 Analyzer # 1 Analyzer # 2 Analyzer # 3 Pooled Mean 7.165 7.161 7.167 7.165 pH units 0.001 0.001 0.001 0.003 Mean 56.7 56.0 56.3 56.3 mmHg Mean 70.1...
  • Page 76 Prime CCS Instructions for Use Manual Stat Profile Prime Quality Control Level 2 Parameter n = 20 Analyzer # 1 Analyzer # 2 Analyzer # 3 Pooled Mean 7.361 7.360 7.362 7.361 pH units 0.002 0.002 0.002 0.002 Mean 41.6 41.3...
  • Page 77 Appendix A Stat Profile Prime Quality Control Level 3 Parameter n = 20 Analyzer # 1 Analyzer # 2 Analyzer # 3 Pooled Mean 7.596 7.597 7.594 7.596 pH units 0.002 0.002 0.002 0.002 Mean 23.6 23.7 23.8 23.7 mmHg Mean 142.2...
  • Page 78 Run-to-Run Precision Performance Estimates of the run to run precision were determined for each of the Stat Profile Prime CCS analyzers by analyzing the following solutions in duplicate over a period of 20 days; 2 runs per day for a total of 40 runs.
  • Page 79 Appendix A Run-to-Run Precision Results pH Precision Data Total Total Pooled Within run Within imprecision Sample Imprecision Mean SD (Sr) run % CV SD (St) QC Level 1 7.164 0.002 0.002 QC Level 2 7.362 0.000 0.001 QC Level 3 7.596 0.000 0.002...
  • Page 80 Prime CCS Instructions for Use Manual Hct Precision Data Total Total Pooled Within run Within imprecision Sample Imprecision Mean (%) SD (Sr) run % CV SD (St) QC Level 1 37.9 0.44 1.15 0.81 2.15 QC Level 2 55.0 0.20 0.37 0.32 0.58...
  • Page 81 Appendix A iCa Precision Data Pooled Total Total Within run Within imprecision Sample Mean Imprecision SD (Sr) run % CV SD (St) (mmol/L) QC Level 1 1.51 0.007 0.45 0.02 1.13 QC Level 2 0.97 0.002 0.22 0.00 0.43 QC Level 3 0.53 0.001 0.23...

  • Page 82: Calibrator Cartridge

    Prime CCS Instructions for Use Manual Lactate Precision Data Pooled Total Total Within run Within imprecision Sample Mean Imprecision SD (Sr) run % CV SD (St) (mmol/L) QC Level 1 0.79 0.022 2.77 0.03 3.58 QC Level 2 2.60 0.012 0.47 0.01 0.54...

  • Page 83: Reference Values

    Appendix A A.4 Reference Values Each laboratory should establish and maintain its own reference values. The values given here should be used only as a guide. ______________________________________________________ 1,2,6 Table A.1 Reference Values Test Value 7.35 - 7.45 35 - 45 mmHg 21 - 28 mmol/L Base Excess (Blood) (-2)-(+3) mmol/L...
  • Page 84 Prime CCS Instructions for Use Manual Table A.2 Reference Values for Adult Whole Blood Test Value Sodium 136 - 146 mmol/L Potassium 3.5 - 5.1 mmol/L Chloride 98 - 106 mmol/L Glucose 65 - 95 mg/dL Lactate 0.7 - 2.5 mmol/L Calcium 1.09 - 1.30 mmol/L ______________________________________________________...

  • Page 85: Ordering Information

    Appendix A A.5 Ordering Information Stat Profile Prime CCS Analyzer supplies and parts are available from Nova Biomedical. DESCRIPTION .................Part # Assembly Probe S Line 100 µL Prime CCS .... 52582 Auto Cartridge Control Prime CCS ......45150 Calibrator Cartridge Prime CCS ......52427 Luer Station Packaged (5x) Prime CCS ....

  • Page 86: Warranty

    A.6 Warranty Subject to the exclusions and upon the conditions specified below, Nova Biomedical or the authorized Nova Biomedical distributor warrants that he will correct free of all charges including labor, either by repair, or at his election, by replacement, any part of an instrument which fails within one (1) year after delivery to the customer because of defective material or workmanship.

  • Page 87: B Principles Of Measurement

    Appendix B B Principles of Measurement This section explains the Principles of Measurement for the Stat Profile Prime CCS Analyzer. B.1 Measured Values Measuring Technology: Ten Planar Sensor Technology (Na, K, Cl, iCa, pH, PCO , PO , Glucose, Lactate, Hematocrit) in a MicroSensor Card B.1.1...
  • Page 88 Prime CCS Instructions for Use Manual ____ S log Equation 4 std = By holding C in Equation 4 constant, E is dependent on only 1 variable, C , the concentration of the ion of interest in the sample. Equation 5 can be rearranged to isolate this variable: (E/S) = (C...
  • Page 89 Appendix B B.1.3 Partial Pressure of Carbon Dioxide (PCO Definition of PCO2 The partial pressure (tension) of carbon dioxide in solution is defined as the partial pressure of carbon dioxide in the gas phase in equilibrium with the blood. Principle of PCO Measurement is measured with a modified pH sensor.

  • Page 90: Partial Pressure Of Po

    Prime CCS Instructions for Use Manual B.1.4 Partial Pressure of Oxygen (PO Definition of PO2 The partial pressure (tension) of oxygen in solution is defined as the partial pressure of oxygen in the gas phase in equilibrium with the blood. PO provides an indication of the availability of oxygen in inspired air.

  • Page 91: Glucose

    Appendix B B.1.6 Glucose Glucose measurement is based on the level of H produced during the enzymatic reaction between glucose and oxygen molecules in the presence of the glucose oxidase enzyme. The reaction is described by the following equation: Glucose Oxidase Glucose + O ––--–––––––––––>...

  • Page 92: Calculated Values

    B.2.1 Temperature Correction for Measured Values The Stat Profile Prime CCS Analyzer allows you to enter the patient temperature when this differs from 37 °C, as for example in patients having surgery under hypothermia. The...

  • Page 93: Calculated Parameters

    Appendix B B.2.2 Calculated Parameters Calculated Bicarbonate Concentration [HCO Bicarbonate Concentration (mmol/L) is calculated using the Henderson-Hasselbalch equation: [HCO pH = pK + log –———— Equation 16 α(PCO where pH and PCO are measured. pK = 6.091 α = 0.0307 = solubility coefficient of CO in plasma at 37 °C Rearranging Equation 16 gives: [HCO...
  • Page 94 Hemoglobin g/dL = Measured Hematocrit ÷ 3.0 Equation 19 NOTE: The hemoglobin calculation is an estimation based on a normal mean corpuscular hemoglobin concentration of 33.3%. The Stat Profile Prime CCS Analyzer hemoglobin estimation from samples with Red cell dyscrasia or hemoglobinopathies may vary significantly from hemoglobin measured by cyanmethemoglobin method.
  • Page 95 Appendix B Standard Bicarbonate Concentration (SBC) The Standard Bicarbonate is defined as the bicarbonate concentration of the plasma of whole blood equilibrated to a of 40 mmHg at a temperature of 37 °C with the hemoglobin fully saturated with oxygen. Standard bicarbonate is calculated as follows: SBC = 24.5 + 0.9Z + Z ( Z - 8 )(0.004 + 0.00025 [Hb]) Equation 21...
  • Page 96 Prime CCS Instructions for Use Manual Oxygen Content (O Oxygen content is defined as the total amount of oxygen contained in a given volume of whole blood, including dissolved oxygen and oxygen bound to hemoglobin. It is expressed in milliliters of oxygen per 100 milliliters of blood (volume %) as calculated from the oxygen saturation and the hemoglobin concentration.
  • Page 97 Appendix B Alveolar Oxygen (A) Alveolar Oxygen refers to the partial pressure of oxygen in alveolar gas. It is calculated as follows: %FIO ––––– (B.P. - 0.045T2 + 0.84T - 16.5) - %FIO 1-(%FIO2/100) **PCO2 –––––– + ––––––––– Equation 26 where T = patient temperature B.P.
  • Page 98 Prime CCS Instructions for Use Manual Arterial Alveolar Oxygen Tension Ratio (a/A) The arterial alveolar oxygen tension ratio is useful to predict oxygen tension in alveolar gas and to provide an index of oxygenation which remains relatively stable when FIO changes.
  • Page 99 Appendix B P50 or PO (0.5)* The P50 is defined as the PO of a sample at which the hemoglobin is 50% saturated with oxygen at pH 7.4, 37°C, and 40 mm Hg PCO for SO % values between 40% and 80%.
  • Page 100 Prime CCS Instructions for Use Manual Ionized Calcium “Normalized” to pH 7.4 The activity and concentration of ionized calcium in whole blood is pH dependent. In vitro, a pH increase of 0.1 unit decreases the ionized calcium level by 4 to 5% (conversely, a pH decrease has an equal but opposite effect).
  • Page 101 Appendix B Anion Gap Anion gap is the difference between the sum of the sodium and potassium concentrations (the cations) and the sum of the chloride and bicarbonate concentrations (the anions), as follows: Anion Gap = (Na + K) - (Cl + [HCO Equation 34 No anion gap is reported if any of the 4 concentrations are not reported.
  • Page 102 Prime CCS Instructions for Use Manual B-16...

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