NOVA Biomedical 51360 13.56 MHz RFID TAG TRANSMITTER HID User Manual

NOVA Biomedical Corporation 13.56 MHz RFID TAG TRANSMITTER HID

User Manual

Stat Profile® PRIME™ CCS Analyzer Instructions for Use Manual 52920
Nova Prime Quick Start GuideConfirm 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 to extend the sample probe.Position the sample over the sample probe then press Aspirate to aspirate the sample.Enter any additional patient or sample information needed while the analysis is completed.Review results.2134675
Nova Biomedical SymBol directory In vitro diagnostic medical device Product fulfills the requirements of Directive 98/79 EC (IVDD) Caution, consult accompanying documents Consult instructions for use Biological risk Catalog number Manufactured by Control Level Batch code Serial Number Temperature limitation Upper Limit of TemperatureUse by (last day of the month) Electronic Waste Authorized Representative in the European Community Laser Radiation - Do Not Stare Into Beam Class II/IEC 825 Laser Product Wavelength: 655 nm LEVELREPEC Nova Biomedical UKLASER RADIATIONDO NOT STARE INTO BEAMCLASS 2 LASER PRODUCTWAVELENGTH: 650 nmMAX. OUTPUT: 1.2 mWEN 60825-1: 2002SNYYYY - MM1
Preface iStat Profile® PRIME™ CCS Instructions for Use ManualOrdering InformationThe Stat Prole® PRIME™ CCS Instructions for Use Manual can be ordered from Nova Biomedical Order Services. Write or call:Nova Biomedical Corporation Telephone: 1-800-458-5813 200 Prospect Street FAX: 1-781-893-6998Waltham, MA 02454-9141 (in the U.S.A.)U.S.A. +1-781-899-0417 (outside the U.S.A.) Web: www.novabiomedical.comREPEC Authorized RepresentativeNova Biomedical UK Telephone:+ 44 1928 704040Innovation House Fax:+ 44 1928 796792Aston Lane South, Runcorn Cheshire, WA7 3FY, UKTrademark and PatentsStat Prole is a registered Trademark of Nova Biomedical Corporation.Stat Prole Prime is a Trademark of Nova Biomedical Corporation.CopyrightPrinted in the U.S.A. Copyright 2013, Nova Biomedical Corporation, Waltham, MA 02454-9141
Prime CCS Instructions for Use Manual Prefaceii Technical AssistanceFor technical assistance inside the United States, call Nova Biomedical Technical Services at:U.S.A.: 1-800-545-NOVA 1-781-894-0800 or FAX: 1-781-894-0585 For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor.Nova Biomedical Canada Ltd. 17 - 2900 Argentia Road Mississauga, Ontario L5N 7X9 Canada Tel: 1-800-263-5999 1 905 567 7700 Nova Biomedical France Parc Technopolis - Bât. Sigma 3 avenue du Canada 1er étage Les Ulis courtaboeuf 91940 France Tel: + 33 1 64 86 11 74Nova Biomedical UKInnovation House Aston Lane South, Runcorn Cheshire, WA7 3FY UK Tel: + 44 1928 704040Nova Biomedical GmbH Messenhauser Str. 42 Roedermark Urberach 63322 Germany Tel: + 49 6074 8448 0 Nova Biomedical KK B-3F Omori Bellport 26 Minami Oi 6-chome Shinagawa-ku Tokyo 140-0013 Japan Tel: + (813) 5471-5461
Table of Contents toc-1 52920A1 2013-091 Introduction 1-11.1 About This Manual ...................................................1-11.2 Safety .......................................................................1-11.3 Installation and Use .................................................1-41.4 Requirements ..........................................................1-41.5 Intended Use, Tests Performed, and Clinical Utility .1-51.6 The Sample .............................................................1-81.6.1 Handling Requirements................................. 1-81.6.2 Acceptable Anticoagulants ............................ 1-92 Getting Started 2-12.1 Power Up Procedure ...............................................2-32.2 The Home Screen: Ready ......................................2-42.2.1 Header Bar .................................................... 2-42.2.2 Selection Area ............................................... 2-52.2.3 Menu Bar ....................................................... 2-62.3 Automatic Calibrations .............................................2-72.3.1 Manual Calibrations ...................................... 2-83 Sample Analysis 3-13.1 Analyzing Patient Samples ......................................3-13.1.1 Analyzing Syringe Samples .......................... 3-13.1.2 Utilizing the Luer Station .............................. 3-33.1.3 Analyzing Sample: Blood Collection Tube .... 3-63.1.4 Analyzing Sample: Capillary Tube ................ 3-83.2 The Sample Results Display..................................3-103.3 Analyzing QC and Prociency Samples ...............3-123.2.1 Analyzing Internal QC Samples .................. 3-123.2.2 Analyzing External QC Samples ................. 3-143.2.3 Analyzing Prociency Samples ................... 3-154 Consumable Replacements 4-14.1 Scheduled Replacements ........................................4-14.2 Calibrator Cartridge & Control Cartridge Changing .4-24.2.1 Change Calibrator Cartridge ......................... 4-34.2.2 Change Control Cartridge ............................. 4-44.3 Change Sensor Card ...............................................4-4
10 Prime CCS Instructions for Use Manualtoc-2 5 Periodic Replacements 5-15.1 Pump Tubing Replacement .....................................5-15.2 Probe Replacement .................................................5-35.2 Reference Sensor Replacement..............................5-55.3 Printer Paper Replacement .....................................5-75.4 Safety Sample Port Replacement............................5-86 Troubleshooting 6-16.1 Troubleshooting Procedures ....................................6-16.2 Error Log ..................................................................6-26.3 Operator Flow Test ..................................................6-26.3.1 Flushing the Reference Sensor..................... 6-26.3.1 Flushing the Sensor Cartridge ...................... 6-36.3.1 Flushing the Sample Probe ........................... 6-4A Appendix A-1A.1 Specications.......................................................... A-1A.1.1 Analytical Specicity ......................................A-3A.2 Analytical Performance Studies .............................. A-5A.3 Calibrator Cartridge .............................................. A-22A.3.1 Traceability Calibrators, Controls, Standards . A-22A.4 Reference Values ................................................. A-23A.5 Ordering Information ............................................. A-25A.6 Warranty ............................................................... A-26B Principles of Measurement B-1B.1 Measured Values .................................................... B-1B.1.1 Na+, K+, Cl-, and iCa .....................................B-1B.1.3 Partial Pressure of PCO2 ..............................B-3B.1.4 Partial Pressure of PO2 ................................. B-4B.1.5 Hematocrit ..................................................... B-4B.1.6 Glucose .........................................................B-5B.1.7 Lactate ..........................................................B-5B.2 Calculated Values ................................................... B-6B.2.1 Temperature Correction for Measured Values .B-6B.2.2 Calculated Parameters..................................B-7
1-11. Intro. 1 Introduction1 IntroductionThis manual provides all necessary instructions for the routine operation and upkeep of all Stat Prole Prime CCS Analyzer. Please read this manual carefully. It has been prepared to help you attain optimum performance from your Analyzer.WARNING: Blood samples and blood products are potential sources of infectious agents. Handle all blood products and ow path components (waste-line, capillary adapter, probe, sensor card, etc.) with care. Gloves and protective clothing are recommended. When performing maintenance and troubleshooting procedures, also use protective eyewear.This section introduces the Prime CCS Analyzer and covers requirements, tests performed, procedural limitations, clinical utility, and sample handling.1.1 About This ManualThis manual is for the Stat Prole Prime CCS Analyzer. Throughout this manual, NOTE: indicates especially important information, CAUTION: indicates information that is critical to avoid instrument damage or incorrect results, and WARNING: indicates possible hazard to the operator.1.2 SafetyPersonnel operating this analyzer must be procient in the operating and replacement procedures of the analyzer. The following safety procedures must be followed.
1-2 Prime CCS Instructions for Use ManualGeneral Safety1. 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. Follow all operating and use instructions.5. Do not use the analyzer near water, for example near a sink, etc.6. Use only with a cart or stand that is recommended by the manufacturer. The analyzer and cart combination should be used with care. Quick stops, excessive force, and uneven surfaces may cause the analyzer and cart combination to overturn.7. Place the analyzer so that its location or position does not interfere with its proper ventilation.8. Place the analyzer away from heat sources.9. Connect the analyzer to a power supply only of the type described in the operating instructions or marked on the analyzer.10. Do not defeat the safety purpose of the polarized or grounding type plug.11. Route power cords so that they are not likely to be walked on or pinched by items placed upon or against them, paying particular attention to cords at plugs, power sockets, and at the point where they exit from the analyzer.12. The analyzer should be cleaned only as recommended by the manufacturer.13. Take care not to let objects or liquids fall into the analyzer.14. The analyzer should be serviced by qualied service personnel.15. Do not attempt to service the analyzer beyond that described in the operating instructions. All other servicing should be referred to qualied service personnel.
1-31. Intro. 1 IntroductionElectrical Safety1. To reduce the risk of electric shock, do not remove the cover.2. There are no user serviceable parts inside the analyzer.3. Servicing must be done by qualified service personnel.4. Toreducetheriskofreorelectricshock,donotexpose the analyzer to water.5. Use Nova Part Number 52413 external power supply to power up the analyzer.6. Ensure that the wall outlet receptacle is properly wired and earth grounded.7. DO NOT use a 3-to-2 wire plug adapter.8. DO NOT use a 2-wire extension cord or a 2-wire multiple-outlet power strip.Federal Communications Commission (FCC) Notice This device complies with Part 15 of the FCC Rules: Operation is subject to the following conditions: 1. This device many not cause harmful interference, and 2. This device must accept any interference received, Including interference that may cause undesired operationChanges and Modications not expressly approved byNova Biomedical Corporation can void your authority to operate this equipment under Federal Communications Commissions rules.Radio Standards Specications (RSS) Notice This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following 2 conditions: 1. This device may not cause interference, and 2. This device must accept any interference, including interference that may cause undesired operation of the device.Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence.L'exploitation est autorisée aux deux conditions suivantes : 1. l'appareil ne doit pas produire de brouillage, et 2. l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
1-4 Prime CCS Instructions for Use ManualChemical and Biological Safety1. Observe all precautionary information printed on the original solution containers.2. Operate the analyzer in the appropriate environment.3. Take all necessary precautions when using pathologic or toxic materials to prevent the generation of aerosols.4. Wear appropriate laboratory attire, e.g., safety glasses, gloves, lab coat, and breathing apparatus, when working with hazardous materials.5. Dispose of all waste solutions according to standard hospital procedures.1.3 Installation and UseThis section covers the installation requirements and assembly procedures for the Stat Prole Prime CCS Analyzer.Prior to use of the analyzer, operators should be familiar with Chapter 2 Operation and Chapter 3 Operating Procedures.NOTE: Under the Warranty, a Nova service representative will install this equipment for you.1.4 RequirementsWorking Area Requirements (Environmental):Keep the working area around the system free of dirt, corrosive fumes, vibration, and excessive temperature changes. Electrical Requirements:• Operating Voltage Range: 90 - 270 VAC• Operating Frequency: 47 - 63 Hz• Power Consumption: Less than 100 WattsAmbient Operating Temperature:• 15°C to 30°C (59°F to 86°F)Operate at Humidity:• 20 to 85% without condensation
1-51. Intro. 1 IntroductionOperate at Altitude:• up to 12,000 feet/3650 metersDimensions: Height: 15.4 in (39.1 cm) Width: 12.0 in (30.5 cm) Depth: 14.4 in (36.2 cm)Weight: 17.5 lb (8.164 kg) without reagent pack 23 lb (10.45 kg) with full reagent packLifting the Analyzer: 1. One person is needed to lift the analyzer. CAUTION: Never use the door (open or closed) to assist you in lifting the analyzer. The door cannot support the weight of the analyzer.2. From the front of the analyzer, place your hands under each side of the analyzer.3. Lift the analyzer. Remember to bend your knees and lift with your legs and not your back.4. Place the analyzer onto a clean and at surface.1.5 Intended Use, Tests Performed, and Clinical UtilityIntended UseThe Stat Prole Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood. It is not intended for Point of Care use.Measured ParametersStat Prole Prime CCS Analyzer: pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose), and Lac (Lactate)Glucose and Lactate are optional.
1-6 Prime CCS Instructions for Use ManualCalculated ParametersFrom the directly measured results, the calculated results are shown in Table 1-1 for each analyzer in the Stat Prole Prime CCS.Table 1-1. Calculated ParametersCalculated Parameters pH, PCO2, PO2 (corrected to patient temperature)Bicarbonate level (HCO3-) Total Carbon Dioxide (TCO2) Base Excess of the blood (BE-b) Base Excess of extracellular uid (BE-ecf) Standard Bicarbonate Concentration (SBC) Total Carbon Dioxide (TCO2) Oxygen Content (O2Ct) Oxygen Capacity (O2Cap) Alveolar Oxygen (A) Arterial Alveolar Oxygen Tension Gradient (AaDO2)Arterial Alveolar Oxygen Tension Ratio (a/A) Respiratory Index (RI) P50 PO2/FIO2 ratio Oxygen Saturation (SO2%) Hemoglobin (Hbc) Anion Gap Normalized Calcium, nCa
1-71. Intro. 1 IntroductionClinical Utility1The following list includes the clinical utility information for each of the analytes measured on the Stat Prole Prime CCS Analyzer.PCO2, 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.Na+ Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance.K+ Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.Cl- Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic brosis and diabetic acidosis.iCa Ionized Calcium measurement is used in the diagnosis and treatment of hypertension, renal disease, and vitamin D related disorders. Also useful in the diagnosis and treatment of patients with increased total protein and/or albumin levels, as in dehydration.Glu Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lac Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.Ref. 1. Burtis, Carl A. Ashwood, Edward R., Burns, David R., 2011. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 5th ed, Philadelphia, PA: W. B. Saunders Co.PO2,pH
1-8 Prime CCS Instructions for Use Manual1.6 The SampleSodium or lithium heparin whole blood samples from syringes, open tubes, small cups, and capillary tubes can be used on the Stat Prole Prime CCS Analyzer. The minimum sample size for analysis is 100 µL. 1.6.1 Handling RequirementsCorrect sample handling is critical to ensure that the blood gas values obtained accurately reect the in vivo state. Ensure that all samples have been obtained and stored following consistent, clinically accepted protocols. It is particularly important to ensure that samples are well mixed before introduction into the analyzer. Nova Biomedical recommends that you analyze the sample within 15 minutes for blood gases. Storing samples on ice is not recommended. Using iced samples may elevate the PO2 result.1 1. Clinical and Laboratory Standards Institute (CLSI), (March 4) 2009, Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition (C46-A2).
1-91. Intro. 1 Introduction1.6.2 Acceptable Anticoagulants• Sodium and lithium heparins are the acceptable anticoagulants for use with the analyzer.• EDTA, citrate, oxalate, and sodium uoride ARE NOT acceptable for use.• Depending on the amount of heparin used in the collection syringe and whether it is lled to capacity with blood, heparin concentrations of 20 I.U. per mL to over 100 I.U. per mL may result.• Excess sodium heparin may elevate sodium results. • Liquid or dry heparin when present in excess may cause errors. Ensure blood collection devices are lled per manufacturer instructions.• Our experience suggests that lyophilized lithium heparin giving a nal concentration in blood of not more than 20 I.U. per mL is acceptable. CAUTION: Stat Prole Prime CCS Analyzer users should take careful note of these considerations when establishing reference intervals and interpreting results.
1-10 Prime CCS Instructions for Use Manual
2-12. Started 2 Getting Started2 Getting StartedThe Stat Prole Prime CCS Analyzer is pictured below. Figure 2.1 Nova Stat Prole Prime CCS1. Touch-screen Display2. Printer3. Sampler4. Door/Front Panel2341
2-2 Prime CCS Instructions for Use ManualFigure 2.2 Analytical Compartment1. Waste Line2. Reference Line3. Pump and Pump Tubing4. Calibrator Cartridge Opening5. Control Cartridge Opening6. Sampler7. Air Detector8. Sensor Card (under cover)9. Reference Sensor (under cover)456389712
2-32. Started 2 Getting Started2.1 Power Up ProcedureWhen 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. During initialization, an internal diagnostic sequence is run: the Sensor Card life; the calibrator cartridge uid level; and the internal QC cartridge uid level are checked.Figure 2.3 Initializing ScreenThe Prime CCS performs a prime cycle. After completion, the screen displays Not Ready.Figure 2.4 Not Ready Screen
2-4 Prime CCS Instructions for Use Manual2.2 The Home Screen: Ready Figure 2.5 Home Screen: ReadyThe 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 BarThe Header Bar is the top section of the display. This is where Ready or Not Ready, Date and Time, Login, and Sensor Card, Calibrator Cartridge, and Control Cartridge status are displayed. The current Date and Time is displayed. When a timed operation is in process, the Date and Time is replaced by a countdown timer. Login with a Lock icon is displayed in the Header Bar. Press the Lock and proceed to login with your Operator ID and password. Only one person can be logged into the analyzer at a time. When logged onto the analyzer, an open lock is shown with the logged in operator ID displayed under it.Header BarSelectionAreaMenu Bar
2-52. Started 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.2.2.2 Selection AreaThe Selection Area is the middle of the display. Panel selection, Sample container selection, and sensor availability are selected here.• Analytes that are displayed in Orange are not available for analysis. If you press the icon of the Orange Analyte, a pop-up window with additional information will display. • Analytes that are displayed in Blue are available and selected for analysis. If you press the icon of a Blue Analyte, the it turns Grey indicating it is not selected for analysis.• Analytes that are displayed in Grey are available but not selected for analysis. If you press the icon of a Grey Analyte, it turns Blue indicating it is not selected for analysis. The Container icon allows you to select the type of container and sample to be analyzed. The Panel icon allows you to select from a predened list of test panels.
2-6 Prime CCS Instructions for Use Manual2.2.3 Menu BarThe 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. The Home icon returns the analyzer to the Home screen by touching this icon. This icon does not display on the Home screen. The Tool Box icon is located at the Menu Bar. Press this icon to display Screen one of the System Menus. The up/down arrow key is pressed to display screen two. From the System Menu, you can also navigate to the Setup Menu. The nd results icon of the Menu Bar will display all the patient results stored on the analyzer. The QC icon will display the QC Menu screen: Run QC, Setup QC Levels, View QC Data, and Setup QC Operations. The Calibrate icon is displayed when all analytes are not calibrated. Press Calibrate to initiate a system calibration. If one or more analytes are calibrated, the Start icon displays. Press Start to begin an analysis.These screens may have other navigational icons. Press the Back icon to return to the previous screen. The Page Up and Page Down icons scroll through the menus that have multiple pages.
2-72. Started 2 Getting Started2.3 Automatic CalibrationsThe Stat Prole 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. If a calibration error occurs, an alert is shown to notify the operator and the test button of the affected analyte is displayed with an orange background to indicate it is not available for testing.Scheduled 2-point calibrations can be delayed once for 10 minutes by pressing the Cancel button. After 10 minutes the rescheduled calibration will begin and cannot be cancelled.
2-8 Prime CCS Instructions for Use Manual2.3.1 Manual CalibrationsA 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. When the analyzer displays Not Ready, samples cannot be run until a 2-point calibration is performed that successfully calibrates the air detectors and at least one analyte. To initiate a calibration from the Not Ready state, press the Calibrate icon on the Menu Bar.A Ready status indicates the air detectors and one or more analytes are calibrated and ready for analysis. To manually calibrate the analyzer from the Ready state press Toolbox icon then press Calibrate .Analytes that display an orange background may be uncalibrated. Press the icon and select Calibrate if displayed to initiate a 2-point calibration.Figure 2.6 Not Ready Screen and Ready Screen
3-13. Analysis 3 Sample Analysis3 Sample AnalysisWhen Ready is displayed on the Home screen the analyzer is ready to analyze samples for any analyte not displaying an 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 cartridge3.1 Analyzing Patient SamplesBefore running a patient sample verify the analyzer is Ready to perform an analysis and that all the desired analytes are available for selection. If necessary, refer to Chapter 2 for additional information.3.1.1 Analyzing Syringe SamplesFrom 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. If required, enter or scan your Password then press .Figure 3.1 Operator ID Screen and Operator Password ScreenIf login is not required or after logging into the analyzer:1. Select the syringe icon from the container drop-down list.
3-2 Prime CCS Instructions for Use Manual2. 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 List3. Press Start icon to begin the analysis.4. If prompted, enter all Required Information and press Start once more to begin the analysis.Figure 3.3 Sample Information Screen5. Prepare the sample for analysis (mix well) then position the sample over the probe and press Aspirate . The sample probe will retract automatically once sufficient sample has been aspirated into the analyzer.Figure 3.4 Syringe Sample without Luer
3-33. Analysis 3 Sample Analysis6. Enter any Required or Optional information while the analysis is running.NOTE: The sample will remain on screen until all Required elds have been entered. The analysis can be cancelled by pressing the X icon but results will not be printed or transmitted.Figure 3.5 Sample Information Screen3.1.2 Utilizing the Luer Station The luer station provides a means of attaching a syringe to the analyzer instead of manually positioning the sample probe in the sample. When utilizing the leur station Nova recommends using the Nova Syringe Clot Catcher to ensure that the sample is positioned correctly for aspiration and to prevent clots from entering the owpath. If a clot catcher is not used, syringes must be lled with sufcient sample for the probe to travel approximately 1-inch (26 mm) into the syringe.From the Home screen: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. If required, enter or scan your Password then press .
3-4 Prime CCS Instructions for Use ManualFigure 3.6 Operator ID Screen and Operator Password ScreenIf 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.Figure 3.7 Ready Screen: Container and Panel Drop-down List3. Prepare the sample for analysis (mix well) then attach the syringe to the luer station.
3-53. Analysis 3 Sample Analysis4. Press Start icon to begin the analysis.Figure 3.8 Syringe Sample with Luer5. If prompted, enter all Required Information and press Start once more to begin the analysis.Figure 3.9 Sample Information Screen6. Press the Aspirate icon to aspirate sample into the analyzer. The sample probe will retract automatically once sufcient sample has been aspirated into the analyzer. 7. Remove the syringe from the luer station.8. Enter any Required or Optional information while the analysis is running.Figure 3.10 Sample Information Screen
3-6 Prime CCS Instructions for Use ManualNOTE: The sample will remain on screen until all Required elds 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 TubeFrom 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. If required, enter or scan your Password then press .Figure 3.11 Operator ID Screen and Operator Password ScreenIf login is not required or after logging into the analyzer:1. Select the blood collection tube 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.
3-73. Analysis 3 Sample AnalysisFigure 3.12 Ready Screen: Container and Panel Drop-down List3. Press Start icon to begin the analysis.4. If prompted, enter all Required Information and press Start once more to begin the analysis.Figure 3.13 Sample Information Screen5. Prepare the sample for analysis (mix well) then position the sample over the probe and press Aspirate . The sample probe will retract automatically once sufficient sample has been aspirated into the analyzer.Figure 3.14 Blood Tube Sample
3-8 Prime CCS Instructions for Use Manual6. Enter any Required or Optional information while the analysis is running.NOTE: The sample will remain on screen until all Required elds have been entered. The analysis can be cancelled by pressing the X icon but results will not be printed or transmitted.Figure 3.15 Sample Information Screen3.1.4 Analyzing Sample from a Capillary TubeFrom 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. If required, enter or scan your Password then press .Figure 3.16 Operator ID Screen and Operator Password ScreenIf login is not required or after logging into the analyzer:1. Select the capillary icon from the container drop-down list.
3-93. Analysis 3 Sample Analysis2. 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 List3. Press Start icon to begin the analysis.4. If prompted, enter all Required Information and press Start once more to begin the analysis.Figure 3.18 Sample Information Screen5. Prepare the sample for analysis (mix well). Then position the capillary tube into the capillary adapter and press Aspirate .Figure 3.19 Capillary Sample
3-10 Prime CCS Instructions for Use Manual6. 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 elds have been entered. The analysis can be cancelled by pressing the X icon but results will not be printed or transmitted.Figure 3.20 Sample Information Screen3.2 The Sample Results DisplayOnce the sample analysis is complete, results for the selected and calculated analytes are shown on the following screen for Blood Results. Each analyte is shown with its measured value, the unit of measure, and a bar graph that provides a visual indication of the sample concentration.The bar graph consists of 3 sections.The rst (left hand) section indicates the sample result is lower than the entered normal range. • The segment is displayed with a Orange background if a sample result is between the low Normal and low Alert range. • The segment is displayed with a Red background when a sample exceeds the low Alert range. The middle section indicates the sample result is within the entered normal range.• The segment is displayed with a Green background when the sample result is within the entered normal range
3-113. Analysis 3 Sample AnalysisThe 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. • The segment is displayed with a Red background when a sample exceeds the high Alert range. Figure 3.21 Blood Results ScreenUse the <Page Up> and <Page Down> buttons to scroll through additional pages of result screens. The number of pages is shown in the upper left corner of the display, e.g., 1 of 3.Press <Print button> to print the results on the analyzer’s thermal printer.Press <Transmit button> to transmit the results to the LIS/HIS system.Press <Home Button> to return to the Home screen.
3-12 Prime CCS Instructions for Use Manual3.3 Analyzing QC and Proficiency SamplesBefore 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.3.2.1 Analyzing Internal Quality Control SamplesFrom 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. If required, enter or scan your Password then press .Figure 3.22 Operator ID Screen and Operator Password ScreenIf 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 3.23 Quality Control Screens
3-133. Analysis 3 Sample Analysis3. 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.Figure 3.24 Quality Control Results ScreensOption 1 QC SetupOption 2 QC Setup
3-14 Prime CCS Instructions for Use Manual3.2.2 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. If required, enter or scan your Password then press .Figure 3.22 Operator ID Screen and Operator Password ScreenIf 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 3.23 Quality Control Screens3. From the drop-down list select the External Control Level to be analyzed.4. Select the lot number of the External Control to be analyzed.5. Enter a QC Comment if desired.
3-153. Analysis 3 Sample Analysis6. 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 over the probe and press Aspirate . The sample probe will retract automatically once sufficient sample has been aspirated into the analyzer.Figure 3.24 External Control to Probe9. Once the analysis is complete press Save to keep the QC results or press Delete to discard the QC results.3.2.3 Analyzing Proficiency 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. If required, enter or scan your Password then press .Figure 3.25 Operator ID Screen and Operator Password Screen
3-16 Prime CCS Instructions for Use ManualIf 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 Screens3. From the drop-down list select the Prociency.4. Press Start to begin the analysis.5. Wait for the Sample Probe to fully extend.6. Prepare the sample for analysis (mix well) then position the sample over the probe and press Aspirate . The sample probe will retract automatically once sufficient sample has been aspirated into the analyzer.Figure 3.27 Prociency Sample to Probe7. Once the analysis is complete press Save to keep the QC results or press Delete to discard the QC results.
4-14. Con Repl 4 Consumable Replacements4 Consumable ReplacementsThe following sections provide detailed information and directions to operate and to maintain the Stat Prole Prime CCS Analyzer at peak efciency. From the Home screen, press the Tool box icon. From these 2 screens, the following consumable replacements can be performed:• Change Sensor Card• Change Calibrate Cartridge • Change Control Cartridge• Replace Pump TubingWARNING: Blood samples and blood products are potential sources of infectious agents. Handle all blood products and ow path components (waste-line, probe, sensor module, etc.) with care. Gloves and protective clothing are recommended. When performing maintenance and troubleshooting procedures, also use protective eyewear.4.1 Scheduled ReplacementsIt is important to perform preventive care as scheduled. The Analyzer Log gives suggested schedules based on number of test. Space is provided for slopes and control results in the Analyzer Log. Replacement procedures are accessed in the System Menu.Figure 4.1 Screen 1 System Menu
4-2 Prime CCS Instructions for Use ManualFigure 4.2 Screen 2 System Menu4.2 Calibrator Cartridge and Control Cartridge ChangingThe 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. Mix the cartridge thoroughly by gentile inversions. Then follow the directions on the screen to replace the cartridges and the capillary adapter.WARNING: When the calibrator cartridge or control cartridge is removed, keep your ngers and hands away from the back of the cartridge compartment. There are sharp needles that can cause injury, and the waste needle is also a biohazard.NOTE: The calibrator or the control cartridge must be replaced through the Tool Box screens. If you remove and replace a cartridge (even if it is the same one) outside these screens, you will not be able to prime the analyzer, and you will not be able to calibrate or to analyze samples (Calibrator Cartridge) or to analyze internal controls (Control Cartridge). If you have removed and replaced a cartridge outside these screens, go to the appropriate screen and press Prime.
4-34. Con Repl 4 Consumable ReplacementsNOTE: 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 Cartridge4.2.1 Change Calibrator Cartridge1. Press the Tool Box icon.2. From the System Menu, press the Change Calibrator Cartridge and wait for pump to stop.3. Open the door, remove old cartridge.4. Slide new cartridge in past the front retaining lip.5. Change the capillary adaptor: slide off used capillary adapter and replace with new one that is provided with Calibrator Cartridge.6. Close door, press the Calibrate icon.
4-4 Prime CCS Instructions for Use Manual4.2.2 Change Control Cartridge1. 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.4 Slide new cartridge in past the front retaining lip.5. Close door, press the Calibrate icon.4.3 Change Sensor Card1. Press the Tool Box icon.2. From the System Menu, press the Change Sensor Card and wait for pump to stop.3. Open the door, remove old cartridge.4 Open Cartridge door. Insert new cartridge. Close Cartridge door.5. Close door, press the Calibrate icon.NOTE: Touch Sensor Card by the edges and replace it the same way back as pictured. Figure 4.4 Sensor CardSensor CardHold from Edges
5-15. Periodic 5 Periodic Replacements5 Periodic ReplacementsPeriodically 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 ReplacementThe pump tubing should be replaced at intervals prescribed in the maintenance log. Replace the tubing that goes around the pump as follows.Figure 5.1 Pump Tubing1. From the Home screen, press the Tool Box icon.2. From the System Menu, select Change Pump Tubing and wait for pump to stop.3. Open the door and push the White Pressure Plate release icon to release the Pump Tubing Pressure Plate.Waste Line Reference LineWhite Pressure Plate Release ButtonPressure PlateHolds W and R Tubings in place.Pump Tubing Manifold Connected to the Reference SensorTab of Tubing Clip
5-2 Prime CCS Instructions for Use ManualFigure 5.2 Release Pump Tubing Pressure Plate3. 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 Manifold5. Slide the pump tubing out by holding the tab of the tubing clip.6. Discard the used tubing assembly.7. Stretch the 2 pump tubings around the pump and slide the tubing clip into the slot under the pump.8. Connect the W-line to the W-labelled outlet above the pump.9. Connect the R-line to the R-labelled outlet above the pump.10. Reconnect the W-pump and R-pump manifold to the top of the Reference Sensor.11. Close the pressure plate until you hear it click into place.12. Place the W and R lines into the hold positions on the right side of the pump as shown in Figure 4.5.13. Close the door and press the Calibrate icon.
5-35. Periodic 5 Periodic Replacements5.2 Probe ReplacementIf 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.2. Remove the capillary adapter from the front of the probe by gently pulling. Figure 5.4 Removing Capillary AdapterNOTE: Capillary Adapter is usually changed with the Calibrator Cartridge since a new capillary adapter comes with the cartridge. 3. Disconnect the cable of the air detector from the analyzer. Figure 5.5 Disconnect the Cable of the Air Detector4. Disconnect the air detector's sample line from the Reference Sensor module using the removal tool attached to the door. Figure 5.6 Removing Sample Line from Reference SensorCable of Air Detector to AnalyzerS-Line with Connection to Reference Sensor
5-4 Prime CCS Instructions for Use Manual5. Pinch together the white probe holder and remove the probe together with the S-line and air detector cable and discard. Figure 5.7 Removing Probe, S-line, and Cable of Air Detector6. Place new Probe assembly until it clicks into place.7. Replace the capillary adaptor back onto the probe8. Reconnect the S-line to the Reference Sensor9. Reconnect the Air Detector Cable into the analyzer.10. Close the door.14. Press the Calibrate icon.Pinch ClampS-Line with Connection to Reference SensorCable of Air Detector to Analyzer
5-55. Periodic 5 Periodic Replacements5.2 Reference Sensor Replacement1. 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. 4 Remove Sensor Card.NOTE: To change the Reference Sensor the Sensor Card must be removed rst. Only touch Sensor Card by the edges.Figure 5.8 Reference SensorPump Tubing ManifoldS-LineSensor CardReference SensorReference Sensor Arm
5-6 Prime CCS Instructions for Use Manual5. 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.Figure 5.9 Slide the Reference Sensor Off to the Right8. Take a new sensor by the arm and slide it back onto the analyzer from right to left.9. Plug the pump tubing manifold to the top of the sensor.10. Reconnect the S-line to the bottom of the sensor.11. Replace the Sensor Card. (See Figure 4.4.)12. Close door, press the Calibrate icon.Slide Reference Sensor Off
5-75. Periodic 5 Periodic Replacements5.3 Printer Paper Replacement1. 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. Feed paper past the cover. Then close the printer cover. Figure 5.10 Replacing the Printer Paper
5-8 Prime CCS Instructions for Use Manual5.4 Safety Sample Port Replacement1. Open the door.2. Slide out the old Safety Sample Port.3. Slide in a new Safety Sample Port.4. Close the door.Figure 5.11 Replacing the Safety Sample Port Docking Station(Safety Sample Port)Slides Out
6-16. TrShoot. 6 Troubleshooting6 TroubleshootingThis section describes the status screens and error codes, and explains the troubleshooting procedures for the Stat Prole 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. Gloves and protective clothing are recommended. When performing maintenance and troubleshooting procedures, also use protective eyewear.6.1 Troubleshooting ProceduresThe recommended troubleshooting procedures use the most logical and direct steps to resolve the error code. The solutions are set up in a block format that lists groups of steps to perform in order to restore operation. The steps are also organized to prevent unnecessary parts replacement until the more common causes for an error have been checked.In the case of multiple error codes, those errors that apply to ow are at the top of the hierarchy. In most cases, when you resolve the ow error codes, the other errors will be resolved as well.If the recommendations given here do not resolve the problem, contact Nova Technical Services for troubleshooting assistanceFOR TECHNICAL ASSISTANCE, CALL TOLL FREE: USA 1-800-545-NOVA Canada 1-800-263-5999 Other Countries Contact the local Nova Biomedical Sales Office or Authorized Nova Biomedical Distributor
6-2 Prime CCS Instructions for Use Manual6.2 Error LogFrom the Service Menu, select Error Log. The Error Log screen is displayed with errors displayed in chronological order. To go to the next or previous error log pages, press 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 Prole Prime Error Logs Error Corrective ActionTo Be Determined6.3 Operator Flow TestThe ow test veries that uid can be pulled through the system from the probe. If water cannot be pulled through the system, a clog or leak exists. The procedure for the ow test and sensor cartridge, reference sensor, and sample probe back ush are as follows.6.3.1 Flushing the Reference Sensor1. 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. 4 Remove Sensor Card.NOTE: To change the Reference Sensor the Sensor Card must be removed rst. Only touch Sensor Card by the edges.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.
6-3Appendix A Appendix A7. Use the sensor arm on the left of the sensor to push the sensor to the right and off.8. Use a syringe lled 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.10. Next attach the tubing of the syringe to the top right pump tubing port. Push the distilled water through the top of the Reference Sensor.11. With the Reference Sensor cleared, take the sensor by the arm and slide it back onto the analyzer from right to left.12. Plug the pump tubing manifold to the top of the sensor.13. Reconnect the S-line to the bottom of the sensor.14. Replace the Sensor Card.15. Close door, press the Calibrate icon.6.3.2 Flushing the Sensor Cartridge1. Press the Tool Box icon.2. From the System Menu, press the Change Sensor Card and wait for pump to stop.3. Open the door, remove the Sensor Cartridge.4. Use the Sensor Cartridge Flushing tool with syringe to ush the cartridge.5. Attach the Flushing Tool to the topnport of the Sensor Cartridge and push distilled water through the cartridge.6 With the Sensor Cartridge now cleared, open cartridge door, insert the cartridge, and close the cartridge door.5. Close the Prime door and press the Calibrate icon.NOTE: Touch Sensor Card by the edges and replace it the same way back.
6-4 Prime CCS Instructions for Use Manual6.3.3 Flushing the Sample Probe1. 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.3. Use the syringe with attached tubing to ush distilled water through the S-line and out the Sample Probe. A small sample cup can be held in front of the Sample Probe to catch the water.4. With the Sample Probe now cleared, reconnect the S-line to the Reference Sensor5. Close the door.6. Press the Calibrate icon.
A-1Appendix A Appendix AA AppendixAppendix A includes analyzer specications, performance data, solutions and reagents, consumable lists, reference information, and warranty for the Stat Prole Prime CCS Analyzer.A.1 SpecificationsMeasurement Range: pH 6.500 -8.000PCO23.0 -200 mmHg 0.4 -26.7 kPaPO20-800 mmHg 0.0 -106.7 kPaHct 12% -70%Na+80 -200 mmol/LK+1.0 -20.0 mmol/LCl-50 -200 mmol/LiCa 0.10 -2.70 mmol/L 0.40 -10.8 mg/dLGlu 15 -500 mg/dL 0.8 -28 mmol/LLac 0.3 -20.0 mmol/L 2.7 -178.0 mg/dL
A-2 Prime CCS Instructions for Use ManualResolutionCalculated Result:HCO3–0.1 mmol/LTCO20.1 mmol/LnCa++ 0.10 mmol/LBE-ecf 0.1 mmol/LBE-b 0.1 mmol/LSBC 0.1 mmol/LO2Ct 0.1 mL/dLP50 0.1 mmHg 0.1 kPaWith entered FiO2: A 0.1 mmHg 0.1 kPaAaDO20.1 mmHg 0.1 kPaa/A 0.1PO2/FiO20.1 mmHg 0.1 kPaAcceptable Samples: Whole Blood (heparinized) Sample Volume: Blood Gas and Electrolyte 100 µL Blood Gas, Electrolyte, Metabolite 100 µL Capillary 100 µL Barometer: 400 - 800 ±1 mmHg, accurate to 1.5%
A-3Appendix A Appendix AA.1.1 Analytical SpecificityAn interference study was performed according to CLSI guideline EP7-A2. The study used spiked and diluted specimens containing potential interfering substances for pH, PO2, PCO2, Na, K, iCa, Cl, glucose and lactate at normal physiological levels. Each sample containing the interfering substance was evaluated against a reference specimen without the interfering substance. Potential interfering substances were selected for test based upon a known potential to interfere with the test methodology. The following table represents substances that were tested without demonstrating a clinically signicant effect on test results:Interfering SubstanceHighest Concentration TestedAnalyte(s) TestedAcetaminophen 20.0 mg/dL Glu, LacAcetylsalicylic acid 3.62 mmol/L Cl, Glu, LacAmmonium Chloride 107.0 µmol/L Na, K, ClAscorbic Acid 50 mg/dL Cl, Glu, LacBenzylkonium Chloride1.0 mg/dL Na, K, Cl, iCa, Calcium Chloride 2.0 mmol/L addition pH, PCO2, PO2, Na, KD-Galactose 10.0 mmol/L LacDopamine Hydrochloride 5.87 µmol/L Glu, LacEDTA 3.4 umol/L GluEthanol 0.5% Glu, LacFluorescein 1.0 mmol/L PCO2, PO2Fluoride 105 µmol/L Glu LacGlucose 1,000 mg/dL LacGlycolic Acid 160.0 mg/dL80.0 mg/dLGluLac
A-4 Prime CCS Instructions for Use ManualInterfering SubstanceHighest Concentration TestedAnalyte(s) TestedGlucosamine 30.0 µmol/L LacHeparin 100 IU/mL Glu, LacHydroxyurea 0.8 mg/dL LacIbuprofen 2,425 µmol/L Glu, LacIntralipid 0.1% pH, PCO2, PO2, Na, K, Cl, iCa, Glu, LacLithium Lactate 25.0 mmol/L Na, K, iCa, GluMagnesium Chloride 15.0 mmol/L Na, Cl, iCaMaltose 13.0 mmol/L Glu, LacMannose 10.0 mmol/L Glu, LacPerchlorate 1.0 mmol/L iCa, Potassium Chloride 5.0 mmol/L addition pH, PCO2, PO2, iCaPotassium Thiocyanate 2,064 µmol/L Cl, Glu, LacPyruvate 309 µmol/L LacSodium Bromide 2.0 mmol/L ClSodium Chloride 10.0 mmol/L addition pH, PCO2, PO2, iCaSodium Citrate 12.0 mmol/L Glu, LacSodium Oxalate 500 mg/dL Glu, LacSodium Salicylate 50.0 mg/dL Glu, LacUrea 40.0 mg/dL LacUric Acid 1.4 mmol/L LacXylose 25.0 mg/dL Glu, LacZinc Chloride 1,300 µg/dL Na, K, iCa,
A-5Appendix A Appendix AThe following table represents substances that were tested that demonstrated a clinically signicant effect on test results:GlucoseInterfering SubstanceConcentration of interfering substanceAnalyte (Glu) concentration Bias mg/dLD-Galactose 10.0 mmol/L 94 mg/dL - 10.7 mg/dLGlucosamine 30 µmol/L 99 mg/dL - 16.6 mg/dLHydroxyurea 0.8 mg/dL 112 mg/dL - 18.8 mg/dLLactateInterfering SubstanceConcentration of interfering substanceAnalyte (Lac) concentration Bias mmol/LGlycolic acid 80 mg/dL 2.7 mmol/L (+) 3.6 mmol/LA.2 Analytical Performance StudiesThree Stat Prole Prime CCS analyzers were compared to 2 Stat Prole pHOx Ultra Analyzers in a laboratory setting by healthcare professionals. 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 Prole Prime CCS Analyzers to the Stat Prole pHOx Ultra Analyzers.Method Comparison StudyHeparinized arterial whole blood discarded specimens from hospital patients were analyzed in duplicate on the 3 Stat Prole Prime CCS Analyzers and 2 Stat Prole pHOx Ultra reference analyzers. The number of samples per run and the total number of runs each day depended upon the availability of blood specimens on any given test day. Some
A-6 Prime CCS Instructions for Use Manualadditional whole blood specimens from consenting donors were tonometered, spiked, or diluted with saline to cover the analytical measurement range for all analytes. The number of data points (N) varies for each parameter due to error, instrument calibration status, or insufcient sample volume to complete analysis.A minimum of 150 whole blood specimens were analyzed for each parameter in syringe collection devices. The samples were analyzed on each of the Stat Prole Prime CCS analyzers and on each of the pHOx Ultra analyzers. The Stat Prole Prime CCS results for each analyzer were compared to the average of the 2 results from the pHOx Ultra comparative method. A minimum of 100 whole blood specimens were analyzed for each parameter in capillary collection tubes. Each specimen was analyzed one time from a capillary container on each Stat Prole Prime CCS analyzer and then immediately run as a syringe specimen on the same Stat Prole Prime CCS analyzer. The capillary test result was compared to the syringe test result from each test system.Bias Chart ResultsThe method comparison bias estimate was analyzed using CLSI Standard EP09-A2 as a reference document. The bias plots for each parameter are summarized and include boundary lines that represent the 95% condence interval across the measurement range based upon each parameter’s between analyzer day-to-day (+/-2SD) performance specication or CV% (whichever is greater). Each bias plot represents 3 Stat Prole Prime CCS analyzers compared to the average result from 2 Stat Prole pHOx Ultra analyzers. Medically relevant low and high concentrations are annotated.
A-7Appendix A Appendix A
A-8 Prime CCS Instructions for Use Manual
A-9Appendix A Appendix A
A-10 Prime CCS Instructions for Use Manual
A-11Appendix A Appendix A
A-12 Prime CCS Instructions for Use ManualSyringe Method Comparison Study Results vs. Stat Prole pHOx UltraTestParameterAnalyzer total # specimens# alteredspecimensspecimenrange SlopeInterceptrpH #1 172 406.523 - 7.8620.9976 0.0099 0.9985#2 170 386.519 - 7.8750.9977 0.0106 0.9990#3 168 416.520 - 7.9531.0018 -0.0225 0.9989PCO2#1 179 34 3.4 - 200.0 0.9854 0.9344 0.9977#2 181 29 3.1 - 192.6 1.0091 0.1547 0.9920#3 176 32 3.3 - 199.10 1.0019 1.1679 0.9980PO2#1 177 43 26.9 - 586.3 1.0046 -1.2710 0.9986#2 167 43 29.5 - 593.2 0.9897 1.4508 0.9988#3 180 42 31.3 - 587.6 1.0035 0.5961 0.9990Hct #1 174 22 12 - 70 1.0445 -1.9271 0.9889#2 170 24 12 - 68 1.0007 -0.6236 0.9871#3 164 19 13 - 70 1.0207 -0.9936 0.9895Na #1 180 30 85.5 - 195.7 1.0189 -2.2841 0.9955#2 186 29 85.1 - 196.7 1.0109 -2.0438 0.9960#3 181 31 85.0 - 198.2 1.0278 -3.5873 0.9961K#1 179 26 1.11 - 19.75 1.0163 -0.0371 0.9996#2 182 25 1.11 - 19.54 1.0138 -0.0619 0.9995#3 183 25 1.12 - 19.79 1.0272 -0.0769 0.9995iCa #1 181 25 0.25 - 2.48 0.9880 0.0457 0.9974#2 180 25 0.25 - 2.42 0.9752 0.0432 0.9958#3 179 25 0.25 - 2.52 1.0059 0.0345 0.9962Cl #1 186 39 52.8 - 189.3 1.0003 1.0158 0.9955#2 183 40 54.1 - 190.6 0.9952 0.6980 0.9787#3 180 37 51.0 - 179.5 0.9569 4.4537 0.9944Glu #1 181 22 35 - 432 0.9987 1.1978 0.9960#2 184 22 39 - 466 1.0005 0.6501 0.9940#3 185 24 39 - 474 1.0007 -2.6844 0.9892Lac #1 182 25 0.4 - 17.8 0.9841 0.0937 0.9974#2 182 26 0.5 - 20.0 1.0463 -0.0577 0.9959#3 182 26 0.4 - 18.7 1.0101 -0.0342 0.9946
A-13Appendix A Appendix ASyringe Method Comparison Study ResultsIndividual Analyzer Performance Data Capillary vs. Syringe ComparisonParameter Analyzer Total # specimensspecimen range Slope Intercept rpH #1 100 6.787 - 7.683 1.0094 -0.0721 0.9988pH units #2 100 6.820 - 7.669 1.0157 -0.1176 0.9986#3 100 6.806 - 7.668 1.0097 -0.0714 0.9989PCO2#1 100 17.7 - 111.0 1.0026 -0.4347 0.9989mmHg #2 100 19.6 - 103.7 0.9939 -0.1404 0.9981#3 100 18.0 - 123.2 0.9897 -0.1897 0.9991PO2#1 100 25.5 - 435.2 0.9942 2.1791 0.9996mmHg #2 100 25.1 - 399.1 1.0082 0.3311 0.9994#3 100 25.6 - 442.7 0.9944 2.2551 0.9994Hct #1 100 14 - 69 1.0013 0.0485 0.9963%#2 100 14 - 66 0.9863 0.6676 0.9960#3 100 13 - 67 1.0161 -0.4917 0.9950Na #1 100 85.0 - 198.1 0.9995 -0.1711 0.9978mmol/L #2 100 85.0 - 192.0 1.0016 -0.4681 0.9988#3 100 85.0 - 194.7 0.9926 0.9061 0.9987K#1 100 2.70 - 19.37 0.9966 0.0934 0.9996mmol/L #2 100 2.63 - 19.36 0.9933 0.0872 0.9996#3 100 2.64 - 19.48 1.0042 0.0375 0.9995iCa #1 100 0.13 - 2.76 1.0083 -0.0422 0.9873mmol/L #2 100 0.12 - 2.70 0.9936 -0.0069 0.9855#3 100 0.13 - 2.52 1.0231 -0.0445 0.9818Cl #1 100 55.8 - 197.1 0.9897 0.1776 0.9997mmol/L #2 100 51.0 - 184.1 0.9921 -0.0870 0.9988#3 100 54.1 - 199.3 0.9905 0.9342 0.9978Glu #1 100 17 - 488 0.9855 -0.4734 0.9998mg/dL #2 100 19 - 491 0.9919 -0.5176 0.9998#3 100 21 - 489 0.9813 0.2346 0.9999Lac #1 100 1.1 - 18.1 1.0034 0.0120 0.9994mmol/L #2 100 1.2 - 19.9 1.0030 -0.0057 0.9995#3 100 1.2 - 19.5 0.9911 -0.0010 0.9994
A-14 Prime CCS Instructions for Use ManualPrecision Study ResultsAnalytical Precision or RepeatabilityThree Stat Prole Prime CCS Analyzers were assessed for within run precision or repeatability within a laboratory setting. The protocol consisted of within run precision, and run–to-run precision studies using 3 different quality control materials.• Stat Prole Prime Quality Control Level 1• Stat Prole Prime Quality Control Level 2• Stat Prole Prime Quality Control Level 3Within Run Precision PerformanceThe protocol consisted of 20 replicates per run for each QC level on each of 3 Stat Prole 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.
A-15Appendix A Appendix AStat Prole Prime Quality Control Level 1Parameter n = 20 Analyzer # 1 Analyzer # 2 Analyzer # 3 PooledpH Mean 7.165 7.161 7.167 7.165pH units SD 0.001 0.001 0.001 0.003PCO2Mean 56.7 56.0 56.3 56.3mmHg SD 0.2 0.2 0.1 0.3CV% 0.4 0.4 0.3 0.6PO2Mean 70.1 70.4 70.5 70.3mmHg SD 0.3 0.5 0.4 0.4CV% 0.5 0.8 0.6 0.6Hct Mean 38 38 38 38%SD 0.5 0.4 0.3 0.5Na Mean 158.1 157.5 158.7 158.1mmol/L SD 0.1 0.4 1.4 0.9CV% 0.1 0.2 0.9 0.6KMean 5.80 5.84 5.81 5.82mmol/L SD 0.00 0.02 0.03 0.03CV% 0.08 0.31 0.54 0.45iCa Mean 1.51 1.52 1.52 1.52mmol/L SD 0.01 0.01 0.00 0.01CV% 0.33 0.36 0.30 0.37Cl Mean 131.0 133.3 130.8 131.7mmol/L SD 0.1 0.4 0.1 1.2CV% 0.1 0.3 0.1 0.9Glu Mean 74 71 74 73mg/dL SD 0.0 0.3 0.0 1.5CV% 0.0 0.4 0.0 2.0Lac Mean 0.9 0.8 0.8 0.8mmol/L SD 0.0 0.0 0.0 0.1CV% 2.5 1.1 1.3
A-16 Prime CCS Instructions for Use ManualStat Prole Prime Quality Control Level 2Parameter n = 20 Analyzer # 1 Analyzer # 2 Analyzer # 3 PooledpH Mean 7.361 7.360 7.362 7.361pH units SD 0.002 0.002 0.002 0.002PCO2Mean 41.6 41.3 41.6 41.5mmHg SD 0.3 0.3 0.3 0.3CV% 0.7 0.8 0.7 0.8PO2Mean 108.8 109.6 109.6 109.4mmHg SD 0.6 1.4 0.3 0.9CV% 0.5 1.3 0.3 0.9Hct Mean 55 55 55 55%SD 0.5 0.3 0.3 0.4Na Mean 140.2 140.1 140.0 140.1mmol/L SD 0.1 0.2 0.6 0.4CV% 0.1 0.1 0.5 0.3KMean 3.84 3.81 3.80 3.82mmol/L SD 0.02 0.01 0.02 0.02CV% 0.43 0.33 0.41 0.53iCa Mean 0.97 0.97 0.98 0.97mmol/L SD 0.01 0.00 0.01 0.01CV% 0.92 0.50 0.52 0.68Cl Mean 102.3 102.2 101.8 102.1mmol/L SD 0.5 0.2 0.1 0.4CV% 0.4 0.2 0.1 0.4Glu Mean 200 202 198 200mg/dL SD 1.1 1.1 0.8 1.9CV% 0.5 0.5 0.4 0.9Lac Mean 2.6 2.6 2.6 2.6mmol/L SD 0.0 0.0 0.0 0.0CV% 0.3 0.3 0.2 0.7
A-17Appendix A Appendix AStat Prole Prime Quality Control Level 3Parameter n = 20 Analyzer # 1 Analyzer # 2 Analyzer # 3 PooledpH Mean 7.596 7.597 7.594 7.596pH units SD 0.002 0.002 0.002 0.002PCO2Mean 23.6 23.7 23.8 23.7mmHg SD 0.3 0.3 0.4 0.3CV% 1.2 1.2 1.5 1.3PO2Mean 142.2 138.7 142.3 141.1mmHg SD 0.7 0.6 0.3 1.8CV% 0.5 0.4 0.2 1.3Hct Mean 69 68 69 69%SD 0.5 0.5 0.5 0.5Na Mean 120.4 120.5 120.2 120.4mmol/L SD 0.1 0.3 0.3 0.3CV% 0.1 0.2 0.3 0.2KMean 1.88 1.86 1.86 1.86mmol/L SD 0.01 0.01 0.00 0.01CV% 0.64 0.46 0.24 0.64iCa Mean 0.52 0.52 0.53 0.52mmol/L SD 0.00 0.00 0.00 0.00CV% 0.90 0.43 0.42 0.95Cl Mean 84.7 84.6 84.9 84.8mmol/L SD 0.5 0.4 0.1 0.4CV% 0.6 0.4 0.1 0.4Glu Mean 320 322 321 321mg/dL SD 1.0 0.9 1.0 1.4CV% 0.3 0.3 0.3 0.4Lac Mean 6.4 6.4 6.5 6.4mmol/L SD 0.0 0.0 0.0 0.0CV% 0.3 0.3 0.2 0.371
A-18 Prime CCS Instructions for Use ManualRun-to-Run Precision PerformanceEstimates of the run to run precision were determined for each of the Stat Prole 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. • Quality Control Material – 3 levels for each parameter in QC mode.• Linearity Standards – 5 levels for each parameter in QC mode.• Whole Blood – 2 tonometered levels for PCO2 and PO2 were prepared on each test day and analyzed in syringe mode. • Whole Blood – 2 levels for Hematocrit were prepared on each test day and were analyzed in syringe mode. Estimates of the run to run precision were determined for each level of Quality Control, Linearity Standard, tonometered blood, and Hematocrit. Statistical analysis for each parameter include the pooled mean, Sr, ST, CV% (pH excluded), and N for all analyzers was calculated.
A-19Appendix A Appendix ARun-to-Run Precision ResultspH Precision DataSample Pooled Mean NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 7.164 240 0.002 --- 0.002 ---QC Level 2 7.362 240 0.000 --- 0.001 ---QC Level 3 7.596 240 0.000 --- 0.002 ---Linearity Std 1 6.899 240 0.003 --- 0.005 ---Linearity Std 2 7.186 240 0.001 --- 0.003 ---Linearity Std 3 7.444 240 0.001 --- 0.002 ---Linearity Std 4 7.615 240 0.001 --- 0.002 ---Linearity Std 5 7.817 240 0.002 --- 0.004 ---PCO2 Precision DataSamplePooled Mean (mmHg)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 58.4 240 0.58 1.00 1.33 2.28QC Level 2 41.9 240 0.06 0.13 0.53 1.26QC Level 3 23.0 240 0.07 0.29 0.42 1.83Linearity Std 1 76.6 240 0.46 0.60 2.22 2.90Linearity Std 2 61.4 240 0.19 0.31 1.32 2.16Linearity Std 3 41.0 240 0.36 0.88 0.59 1.44Linearity Std 4 25.3 240 0.06 0.23 0.51 2.02Linearity Std 5 17.3 240 0.10 0.56 0.83 4.82Blood Gas ( A ) 26.5 240 0.34 1.29 0.93 3.52Blood Gas ( B ) 53.4 240 0.44 0.82 2.03 3.80PO2 Precision DataSamplePooled Mean (mmHg)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 70.2 240 0.84 1.19 2.02 2.88QC Level 2 110.1 240 0.55 0.50 1.16 1.05QC Level 3 143.8 240 0.39 0.27 1.21 0.84Linearity Std 1 21.6 240 1.45 6.73 2.68 12.43Linearity Std 2 60.6 240 1.07 1.77 2.96 4.88Linearity Std 3 107.2 240 0.98 0.91 2.23 2.08Linearity Std 4 158.9 240 0.69 0.44 2.41 1.52Linearity Std 5 453.9 240 3.92 0.86 14.33 3.16Blood Gas ( A ) 111.5 240 1.29 1.16 3.05 2.74Blood Gas ( B ) 61.4 240 0.50 0.81 2.09 3.40
A-20 Prime CCS Instructions for Use ManualHct Precision DataSample Pooled Mean (%) NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 37.9 240 0.44 1.15 0.81 2.15QC Level 2 55.0 240 0.20 0.37 0.32 0.58QC Level 3 68.6 240 0.18 0.26 0.43 0.63Linearity Std 1 73.4 240 0.30 0.41 0.43 0.59Linearity Std 2 58.5 240 0.38 0.65 0.44 0.74Linearity Std 3 55.3 240 0.29 0.52 0.41 0.73Linearity Std 4 36.4 240 0.34 0.93 0.45 1.24Linearity Std 5 27.7 240 0.38 1.37 0.48 1.73Hct ( A ) 43.4 240 0.20 0.46 1.12 2.57Hcy ( B ) 60.7 240 0.28 0.47 1.22 2.01Na Precision DataSamplePooled Mean (mmol/L)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 158.3 240 0.56 0.35 0.68 0.43QC Level 2 140.1 240 0.12 0.09 0.25 0.18QC Level 3 120.2 240 0.08 0.07 0.18 0.15Linearity Std 1 89.7 240 0.45 0.50 0.56 0.62Linearity Std 2 116.1 240 0.25 0.21 0.52 0.45Linearity Std 3 132.0 240 0.53 0.40 0.71 0.54Linearity Std 4 154.5 240 0.40 0.26 0.63 0.41Linearity Std 5 163.7 240 0.43 0.26 0.80 0.49K Precision DataSamplePooled Mean (mmol/L)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 5.81 240 0.020 0.34 0.03 0.48QC Level 2 3.81 240 0.005 0.14 0.01 0.36QC Level 3 1.87 240 0.002 0.13 0.02 0.97Linearity Std 1 11.70 240 0.041 0.35 0.07 0.59Linearity Std 2 1.91 240 0.006 0.32 0.02 0.92Linearity Std 3 4.36 240 0.014 0.32 0.02 0.55Linearity Std 4 6.38 240 0.024 0.38 0.04 0.63Linearity Std 5 1.60 240 0.006 0.40 0.02 1.23
A-21Appendix A Appendix AiCa Precision DataSamplePooled Mean (mmol/L)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 1.51 240 0.007 0.45 0.02 1.13QC Level 2 0.97 240 0.002 0.22 0.00 0.43QC Level 3 0.53 240 0.001 0.23 0.01 1.85Linearity Std 1 2.81 240 0.031 1.09 0.05 1.78Linearity Std 2 1.44 240 0.004 0.26 0.01 0.53Linearity Std 3 1.06 240 0.002 0.21 0.01 0.63Linearity Std 4 0.51 240 0.001 0.14 0.01 1.31Linearity Std 5 0.17 240 0.001 0.58 0.01 6.38Cl Precision DataSamplePooled Mean (mmol/L)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 131.5 240 0.57 0.43 2.30 1.75QC Level 2 103.0 240 0.72 0.70 1.52 1.48QC Level 3 86.1 240 0.27 0.32 1.38 1.60Linearity Std 1 73.5 240 0.15 0.21 1.26 1.71Linearity Std 2 82.6 240 0.10 0.12 0.67 0.82Linearity Std 3 100.5 240 0.11 0.11 0.67 0.66Linearity Std 4 124.5 240 0.11 0.09 1.45 1.17Linearity Std 5 133.5 240 0.13 0.10 2.04 1.53Glucose Precision DataSamplePooled Mean (mg/dL)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 71.3 240 1.28 1.79 1.69 2.37QC Level 2 196.9 240 0.81 0.41 1.33 0.67QC Level 3 318.6 240 2.32 0.73 3.31 1.04Linearity Std 1 378.0 240 5.31 1.41 14.89 3.94Linearity Std 2 67.4 240 0.60 0.88 2.46 3.64Linearity Std 3 179.7 240 1.64 0.91 3.79 2.11Linearity Std 4 260.0 240 1.92 0.74 5.50 2.11Linearity Std 5 n/a
A-22 Prime CCS Instructions for Use ManualLactate Precision DataSamplePooled Mean (mmol/L)NWithin run SD (Sr)Within run % CVTotal imprecision SD (St) Total Imprecision %CVQC Level 1 0.79 240 0.022 2.77 0.03 3.58QC Level 2 2.60 240 0.012 0.47 0.01 0.54QC Level 3 6.38 240 0.023 0.35 0.06 0.87Linearity Std 1 13.36 240 0.229 1.71 0.79 5.91Linearity Std 2 0.67 240 0.013 1.97 0.08 12.71Linearity Std 3 2.53 240 0.022 0.87 0.07 2.88Linearity Std 4 6.59 240 0.056 0.85 0.26 3.92Linearity Std 5 10.51 240 0.086 0.82 0.45 4.26A.3 Calibrator CartridgeThe concentrations of the internal standards are printed on the Calibrator Cartridge. In addition to the calibrators and solutions, the Calibrator Cartridge has a self-contained waste bag for safe disposal of waste.A.3.1 Traceability of Calibrators, Controls, and StandardsChemistry analytes are traceable to the Standard Reference Materials of the National Institute of Standards and Technology (NIST). SO2 is traceable to tonometry.
A-23Appendix A Appendix AA.4 Reference ValuesEach laboratory should establish and maintain its own reference values. The values given here should be used only as a guide.______________________________________________________Table A.1 Reference Values1,2,6 Test Value pH 7.35 - 7.45 PCO2 35 - 45 mmHg HCO3- 21 - 28 mmol/L Base Excess (Blood) (-2)-(+3) mmol/L PO2 83 - 108 mmHg SO2 (arterial whole blood) 95 - 98% Hematocrit (Hct) (Male) 39 - 49% (Female) 35 - 45% Hemoglobin (Hb) (Male) 13.2 - 17.3 g/dL (Female) 11.7 - 15.5 g/dL______________________________________________________
A-24 Prime CCS Instructions for Use ManualTable A.2 Reference Values for Adult Whole Blood Test Value Sodium2 136 - 146 mmol/L Potassium2 3.5 - 5.1 mmol/L Chloride2 98 - 106 mmol/L Glucose2 65 - 95 mg/dL Lactate4,5 0.7 - 2.5 mmol/L Calcium3 1.09 - 1.30 mmol/L______________________________________________________References:1. Statland, Bernard. 1987. Clinical Decisions Levels for Lab Tests, Medical Economics Books.2. Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz Textbook of Clinical Chemistry. Philadelphia, PA: W. B. Saunders Co.3. Kost, G.T. 1993. The Signicance of Ionized Calcium in Cardiac and Critical Care. Arch. Pathol. Lab Med. Vol. 117: pp 890-896.4. Toffaletti, J., Hammes, M. E., Gray, R., Lineberry, B., and Abrams, B. 1992. Lactate Measured in Diluted and Undiluted Whole Blood and Plasma: Comparison of Methods and Effect of Hematocrit. Clinical Chemistry, Vol. 38, No. 12.5. Bernstein, W.K., Aduen, J., Bhatiani, A., Kerzner, R., Davison, L., Miller, C., and Chernow, B. 1994. Simultaneous Arterial and Venous Lactate Determinations in Critically Ill Patients. Critical Care Medicine, Vol. 22.6. Burtis, Carl A. Ashwood, Edward R., Burns, David R., 2011. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 5th ed, Philadelphia, PA: W. B. Saunders Co.
A-25Appendix A Appendix AA.5 Ordering InformationStat Prole Prime CCS Analyzer supplies and parts are available from Nova Biomedical.DESCRIPTION .........................................................................Part #Assembly Probe S Line 100 µL Prime CCS ............ 52582Auto Cartridge Control Prime CCS ......................... 45150Calibrator Cartridge Prime CCS .............................. 52427Luer Station Packaged (5x) Prime CCS ................. 52669Prime Calibrator Cartridge CCS 100 Sample ......... 52862Prime Calibrator Cartridge CCS 200 Sample ......... 53364Prime Calibrator Cartridge CCS 300 Sample ......... 52863Prime Calibrator Cartridge CCS 400 Sample ......... 53466Prime Calibrator Cartridge CCS 500 Sample ......... 53467Prime Calibrator Cartridge CCS 600 Sample ......... 53468Prime Calibrator Cartridge CCS Comp 100 Sample . 52861Prime Calibrator Cartridge CCS Comp 200 Sample . 53365Prime Calibrator Cartridge CCS Comp 300 Sample . 52427 Prime Calibrator Cartridge CCS Comp 400 Sample . 53105Prime Calibrator Cartridge CCS Comp 500 Sample . 53469Prime Calibrator Cartridge CCS Comp 600 Sample . 53470Prime Pump Harness .............................................. 52484Prime Sensor Card CCS (without Glu/Lac) ............. 42032Prime Sensor Card CCS Comp .............................. 42033Reference Sensor, Prime CCS ............................... 42043
A-26 Prime CCS Instructions for Use ManualA.6 WarrantySubject to the exclusions and upon the conditions specied 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. This warranty does not include normal wear from use and excludes: (A) Service or parts required for repair to damage caused by accident, neglect, misuse, altering the Nova equipment, unfavorable environmental conditions, electric current uctuations, work performed by any party other than an authorized Nova representative or any force of nature; (B) Work which, in the sole and exclusive opinion of Nova, is impractical to perform because of location, alterations in the Nova equipment or connection of the Nova equipment to any other device; (C) Specication changes; (D) Service required to parts in the system contacted or otherwise affected by expendables or reagents not manufactured by Nova which cause shortened life, erratic behavior, damage or poor analytical performance; (E) Service required because of problems, which, in the sole and exclusive opinion of Nova, have been caused by any unauthorized third party; or (F) Instrument refurbishing for cosmetic purposes. All parts replaced under the original warranty will be warranted only until the end of the original instrument warranty. All requests for warranty replacement must be received by Nova or their authorized distributor within thirty (30) days after the component failure. Nova Biomedical reserves the right to change, alter, modify or improve any of its instruments without any obligation to make corresponding changes to any instrument previously sold or shipped. All service will be rendered during Nova’s principal hours of operation. All requests for service outside Nova’s principal hours of operation will be rendered at the prevailing weekend/holiday rates after receipt of an authorized purchase order. Contact Nova for specic information.The above warranties are invalid if:1. The date printed on the package label has been exceeded. 2. Non-Nova Biomedical reagents or controls are used, as follows: Nova Biomedical will not be responsible for any warranties on parts if these parts are used in conjunction with and are adversely affected by reagents, controls, or other material not manufactured by Nova but which contact or affect such parts. Reagent formulations not manufactured by Nova Biomedical may contain acids, concentrated salt solutions, and articial preservatives that have been shown to cause problems such as shortened sensor/electrode life, sensor/electrode drift, erratic analytical results, and inaccurate instrument performance.THE FOREGOING OBLIGATIONS ARE IN LIEU OF ALL OTHER OBLIGATIONS AND LIABILITIES INCLUDING NEGLIGENCE AND ALL WARRANTIES, OF MERCHANTABILITY OR OTHERWISE, EXPRESSED OR IMPLIED IN FACT BY LAW AND STATE OUR ENTIRE AND EXCLUSIVE LIABILITY AND BUYER’S EXCLUSIVE REMEDY FOR ANY CLAIM OF DAMAGES IN CONNECTION WITH THE SALE OR FURNISHING OF GOODS OR PARTS, THEIR DESIGN, SUITABILITY FOR USE, INSTALLATION OR OPERATION. NOVA BIOMEDICAL WILL IN NO EVENT BE LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES WHATSOEVER, AND OUR LIABILITY UNDER NO CIRCUMSTANCES WILL EXCEED THE CONTRACT PRICE FOR THE GOODS FOR WHICH THE LIABILITY IS CLAIMED.
B-1Appendix B Appendix BB Principles of MeasurementThis section explains the Principles of Measurement for the Stat Prole Prime CCS Analyzer.B.1 Measured ValuesMeasuring Technology: Ten Planar Sensor Technology (Na, K, Cl, iCa, pH, PCO2, PO2, Glucose, Lactate, Hematocrit) in a MicroSensor CardB.1.1 Sodium, Potassium, Chloride, and Ionized CalciumCalculating Sample ConcentrationEquation 1 links the voltage of the cell (Em) to the activity of the ion. Activity is related to concentration (C) through the activity coefcient in the relation a = f * C. The activity coefcient is a function of ionic strength. Thus, Equation 1 can be rewritten in terms of concentration as follows:Ecell = Eo + S log ao - Er - Ej Equation 1 Ecell = Eo + S (log(f * C)o) - Er - Ej Equation 2 Similarly, Equation 2 is rewritten: (fC)xE = Ex - Estd = S log _________ Equation 3 (fC)std The total ionic strength of whole blood is relatively constant over the physiological range.1 As a result, the activity coefcients of sodium, potassium, calcium, and chloride can be assumed to be constant. The internal standards are formulated to reect the same ionic strength as that of whole blood. Therefore, a given ion’s activity coefcient can be assumed to be equal in the standard and sample. The activity coefcient terms in Equation 3 cancel out with these results:
B-2 Prime CCS Instructions for Use Manual CxE = Ex - Estd = S log ____ Equation 4 Cstd By holding Cstd in Equation 4 constant, E is dependent on only 1 variable, Cx, the concentration of the ion of interest in the sample. Equation 5 can be rearranged to isolate this variable:Cx = (Cstd) 10(E/S) Equation 5The analyzer’s microcomputer uses Equation 5 to calculate the concentration of sodium, potassium, calcium, and chloride ions in the sample.B.1.2 pH SensorDefinition of pHThe pH of an unknown sample is calculated using the following equation: Estd C – ExpH Estd C - Ex= pHstd C + ––––––––– Equation 6 Slope Estd C – Exwhere Slope = —————————— Equation 7 pHstd C – pHstd DPrinciple of pH MeasurementpH is measured using a hydrogen ion selective membrane. One side of the membrane is in contact with a solution of constant pH. The other side is in contact with a solution of unknown pH. A change in potential develops which is proportional to the pH difference of these solutions. This change in potential is measured against a reference electrode of constant potential. The magnitude of the potential difference is a measure, then of the pH of the unknown solution.
B-3Appendix B Appendix BB.1.3 Partial Pressure of Carbon Dioxide (PCO2)Definition of PCO2The partial pressure (tension) of carbon dioxide in solution is dened as the partial pressure of carbon dioxide in the gas phase in equilibrium with the blood.Principle of PCO2 MeasurementPCO2 is measured with a modied pH sensor. Carbon dioxide in the unknown solution makes contact with a hydrogen ion selective membrane CO2 diffuses across the membrane into a thin layer of bicarbonate buffer in response to partial pressure difference. This solution then becomes equilibrated with the external gas pressure of the uid in contact with the outer surface of the membrane. CO2 in the solution becomes hydrated producing carbonic acid which results in a change in hydrogen ion activity.CO2 + H20 <=> H2CO3 <=> H+ + [HCO-3 ] Equation 8The pH of this internal solution varies with the PCO2 according to the Henderson-Hasselbalch equation. pH = pKa + log {HCO3- / PCO2 * a}The measured potential is related to the logarithm of PCO2 content of the sample after compensation of the measured potential of the pH sensor.
B-4 Prime CCS Instructions for Use ManualB.1.4 Partial Pressure of Oxygen (PO2)Definition of PO2The partial pressure (tension) of oxygen in solution is dened as the partial pressure of oxygen in the gas phase in equilibrium with the blood. PO2 provides an indication of the availability of oxygen in inspired air.Principle of PO2 MeasurementPO2 is measured amperometrically by the generation of a current at the sensor surface. As oxygen diffuses through a gas permeable membrane, the oxygen molecules are reduced at the cathode, consuming 4 electrons for every molecule of oxygen reduced. This ow of electrons is then measured by the sensor and is directly proportional to the partial pressure of oxygen.B.1.5 HematocritHematocrit is dened as the percentage of red blood cells to the total blood volume and can be obtained by measuring electrical resistance of the blood sample. Two standard solutions are used to calibrate the hematocrit sensor and to obtain the slope. The analyzer then measures the electrical resistance of the blood sample to obtain the hematocrit value. The hematocrit value obtained is corrected for the concentration of the sodium ion.
B-5Appendix B Appendix BB.1.6 GlucoseGlucose measurement is based on the level of H2O2 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 OxidaseGlucose + O2 ––--–––––––––––> Gluconic acid + H2O2 Equation 9At a constant potential of 0.70 volts, electroactive H2O2 is oxidized at the surface of the platinum anode as follows:H2O2 ––––––––> 2H+ + O2 + 2e- Equation 10The current generated by the ow of electrons at the surface of the platinum sensor is proportional to the glucose concentration of the sample.B.1.7 LactateLactate measurement is based on the level of H2O2 produced during the enzymatic reaction between lactate and oxygen molecules in the presence of the lactate oxidase enzyme. The reaction is described by the following equation: Lactate OxidaseLactate + O2 –––––––––––––> Pyruvate acid + H2O2 Equation 11 At a constant potential of 0.70 volts, electroactive H2O2 is oxidized at the surface of the platinum anode as follows:H2O2 ––––––––> 2H+ + O2 + 2e- Equation 12The current generated by the ow of electrons at the surface of the platinum sensor is proportional to the lactate concentration of the sample.
B-6 Prime CCS Instructions for Use ManualB.2 Calculated ValuesThe analyzer’s microcomputer uses the measured results to calculate other clinically relevant parameters. This section outlines the equations used to calculate these values.B.2.1 Temperature Correction for Measured ValuesThe Stat Prole 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 pH, PCO2, and PO2 sample values, at the patient’s actual temperature, are then calculated as follows:pH(corrected) = pH + [- 0.0147 + 0.0065 (7.400 - pH)](T - 37) Equation 13PCO2 (corrected) = PCO2 x e (0.04375(T - 37)) Equation 14PO2 (corrected) = PO2 x 10U Equation 15 (5.49 x 1011) Y + 0.071U = –————————— x (T - 37) (9.72 x 10-9)Y + 2.30and Y = e[3.88 x ln(PO2)]([ ])
B-7Appendix B Appendix BB.2.2 Calculated ParametersCalculated Bicarbonate Concentration [HCO3-]2Bicarbonate Concentration (mmol/L) is calculated using the Henderson-Hasselbalch equation: [HCO3-]pH = pK + log –———— Equation 16 α(PCO2 ) where pH and PCO2 are measured.pK = 6.091 α = 0.0307 = solubility coefcient of CO2 in plasma at 37 °C Rearranging Equation 16 gives:Log10 [HCO3-] = pH + log10 PCO2 - 7.604 Equation 17*The equations are from NCCLS standards2.Total Carbon Dioxide Content (TCO2)*TCO2 (mmol/L) includes both dissolved carbon dioxide and [HCO3-] and is calculated as follows: TCO2 = [HCO3-] + α(PCO2) Equation 18where PCO2 is measured and [HCO3-] is calculated from Equation 17.* The equations are from Reference 2.
B-8 Prime CCS Instructions for Use ManualHemoglobin (Calculated)The hemoglobin is calculated based on the following calculation:Hemoglobin g/dL = Measured Hematocrit ÷ 3.0 Equation 19NOTE: The hemoglobin calculation is an estimation based on a normal mean corpuscular hemoglobin concentration of 33.3%. The Stat Prole Prime CCS Analyzer hemoglobin estimation from samples with Red cell dyscrasia or hemoglobinopathies may vary signicantly from hemoglobin measured by cyanmethemoglobin method.Base Excess of Blood (BE-B)*Base excess of blood is dened as the concentration of titratable base needed to titrate blood to pH 7.40 at 37 °C while the PCO2 is held constant at 40 mm Hg. Base excess of blood is calculated as follows:BE-B = (1 - 0.014[Hb]) ([HCO3-] - 24 + (1.43[Hb] + 7.7)(pH - 7.4) ) Equation 20* The equations are from Reference 2.
B-9Appendix B Appendix BStandard Bicarbonate Concentration (SBC)The Standard Bicarbonate is dened as the bicarbonate concentration of the plasma of whole blood equilibrated to a PCO2 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 21where Z = [BE-B] - 0.19 [Hb] ((100 - SO2 )/100)[Hb] = The hemoglobin value which is measured, manually entered, or is the 14.3 g/dL default valueBase Excess Extracellular Fluid (BE-ECF)*The Base Excess Extracellular uid is a corrected form of the Base Excess Blood in which allowance has been made for the fact that blood is only approximately 37% of the extracellular uid volume. Base excess is calculated as follows:BE-ECF = [HCO3-]- 25 + 16.2 (pH - 7.40) Equation 22* The equations are from Reference 2.
B-10 Prime CCS Instructions for Use ManualOxygen Content (O2Ct)Oxygen content is dened 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. Four moles of oxygen (22,393 mL/mol at standard temperature and pressure) can combine with 1 mole of hemoglobin (64,458 g/mol) so that oxygen capacity is equal to 4 (22393)_________ = 1.39 mL of O2 per gram of Hb Equation 23 64458 therefore O2Ct = (1.39 [Hb]) (SO2/100) + (0.0031 [PO2]) Equation 24where 0.0031 is the solubility coefcient of O2.On the analyzer, hemoglobin can be manually entered, calculated from the measured hematocrit, or occur as a default value.Oxygen Saturation (O2Sat)Oxygen saturation is dened as the amount of oxyhemoglobin in blood expressed as a fraction of the total amount of hemoglobin able to bind oxygen. It is calculated as follows: [PO2']3 + 150 [PO2']O2Sat = –––––––––––––––––––––––– x100 Equation 25 [PO2']3 + 150 [PO2'] + 23400where [PO2'] = [PO2] x e [2.3026 x (0.48 (pH – 7.4) – 0.0013([HCO3-] – 25))]NOTE: The equation for calculating oxygen saturation assumes a normal shape and position of the patient's oxygen dissociation curve.
B-11Appendix B Appendix BAlveolar Oxygen (A)Alveolar Oxygen refers to the partial pressure of oxygen in alveolar gas. It is calculated as follows: %FIO2A = ––––– (B.P. - 0.045T2 + 0.84T - 16.5) - 100 %FIO2 1-(%FIO2/100) **PCO2 –––––– + ––––––––– 100 0.8 Equation 26where T = patient temperature B.P. = barometric pressure %FIO2 = fraction inspired oxygen, as a percent** Temperature corrected gas valueArterial Alveolar Oxygen Tension Gradient (AaDO2)The arterial alveolar oxygen tension gradient is a useful index of gas exchange within the lungs and is dened as: Aa DO2 = A- **PO2 Equation 27** Temperature corrected gas valueNOTE: For capillary samples, AaDO2 results have an asterisk (*). AaDO2 results are dependent on how the samples are drawn and handled, thus care must be taken when interpreting these calculated results.)[(]
B-12 Prime CCS Instructions for Use ManualArterial 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 FIO2 changes. a/A = **PO2/A Equation 28** Temperature corrected gas valueArterial-Mixed Venous O2 Content Difference ( a – v– DO2 )When the oxygenated blood from the lungs comes into contact with tissues, it releases oxygen and takes up carbon dioxide. The quantity of oxygen donated depends on 2 factors:• The speed of blood ow• The consumption by tissuesThe rst factor can be detected from the cardiac output, and the second depends on the metabolic rate of the patient.The a – v– DO2 is the measurement of the difference in oxygen content between the arterial blood and the mixed venous blood (the amount of oxygen donated to the tissues). This parameter is not an indication of the basic metabolism or of the cardiac output. It is an nonspecic indication; even if, in some cases completely relaxed patients with a constant metabolic rate, it can be related to the cardiac output. a – v– DO2 = CaO2 – Cv– O2 Equation 29
B-13Appendix B Appendix BP50 or PO2 (0.5)*The P50 is dened as the PO2 of a sample at which the hemoglobin is 50% saturated with oxygen at pH 7.4, 37°C, and 40 mm Hg PCO2 for SO2% values between 40% and 80%.P50(uncorrected)=PO2/(SO2%/(100-SO2%))0.37 Equation 30For measured SO2% between 80 and 96.9%, the equation is as follows:Where z = tanh(0.5343 * x); x = ln(0.133 * PO2/7); y = ln(SO2%/(100-SO2%))-1.875P50(uncorrected)=26.902 * exp(1.121 * (y-x-3.5z)/(1.87 * z2 + z - 2.87)) Equation 31The corrected equation is as follows:log P50(corrected) = log P50(uncorrected) + 0.43 (pH – 7.4) – 0.05 (log PCO2/40) – 0.0131(T – 37) Equation 32* The equations are from Reference 4.
B-14 Prime CCS Instructions for Use ManualIonized Calcium “Normalized” to pH 7.4The 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). The sample of choice for ionized calcium determination is anaerobically collected whole blood.If an anaerobic sample is not available, by measuring the actual pH of the sample at which the ionized calcium concentration was measured normalized ionized calcium can be calculated. The normalized ionized calcium represents what the ionized calcium concentration would have been if the initial pH was 7.40 (the midpoint of the pH reference range). The equation used for this calculation is as follows:log [iCa] 7.4 = log [Ca++]X - 0.24 (7.4 - X) Equation 33where X = measured pH of the sample[iCa]X = ionized calcium concentration in the sample at the measured pH[iCa] 7.4 = normalized concentration of ionized calcium at pH 7.40The equation assumes a normal concentration of total protein and may be used for measured values between pH 7.2 and 7.6. Between pH 6.9 and 7.2 and between pH 7.6 and 8.0, modied forms of the equation are used. Normalized ionized calcium values for samples with pH outside the range pH 6.9 to pH 8.0 are not displayed.
B-15Appendix B Appendix BAnion GapAnion 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 + [HCO3-}) Equation 34 No anion gap is reported if any of the 4 concentrations are not reported. Any calculated anion gap less than 0.0 mmol/L is not reported.References:1. Mohan, M.S. and Bates, R.G. 1977. Blood pH, Gases and Electrolytes. NBS Special Publication, 450. U.S. Government Printing Ofce.2. National Committee for Clinical Laboratory Standards. 1999. Tentative Standard for Denitions of Quantities and Conventions Related to Blood pH and Gas Analysis. NCCLS 2:10.3. Williams, W.J., Beutler, E., Ersley, A.J., and Rundles, R.W. 1977. Hematology. 2nd ed. McGraw-Hill Co.4. Burtis, Carl A. and Ashwood, Edward R., ed. 1999. Tietz Textbook of Clinical Chemistry. Philadelphia, PA: W. B. Saunders Co.
B-16 Prime CCS Instructions for Use Manual

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