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A-3

Appendix A

  

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, 

P

O

2

, 

P

CO

2

, 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 significant effect on test results:

Interfering 

Substance

Highest 

Concentration Tested

Analyte(s) 

Tested

Acetaminophen

20.0 mg/dL

Glu, Lac

Acetylsalicylic acid

3.62 mmol/L

Cl, Glu, Lac

Ammonium Chloride

107.0 µmol/L

Na, K, Cl

Ascorbic Acid

50 mg/dL

Cl, Glu, Lac

Benzylkonium Chloride 1.0 mg/dL

Na, K, Cl, iCa, 

Calcium Chloride

2.0 mmol/L addition

pH, 

P

CO

2

, 

P

O

2

, 

Na, K

D-Galactose

10.0 mmol/L

Lac

Dopamine 

Hydrochloride

5.87 µmol/L

Glu, Lac

EDTA

3.4 umol/L

Glu

Ethanol

0.5%

Glu, Lac

Fluorescein

1.0 mmol/L

P

CO

2

, 

P

O

2

Fluoride

105 µmol/L

Glu Lac

Glucose

1,000 mg/dL

Lac

Glycolic Acid

160.0 mg/dL

80.0 mg/dL

Glu

Lac

Содержание Stat Profile PRIME

Страница 1: ...Stat Profile PRIME CCS Analyzer Instructions for Use Manual 52920...

Страница 2: ......

Страница 3: ...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 Positionthesampleoverthe sample probe...

Страница 4: ......

Страница 5: ...ed by Control Level Batch code Serial Number Temperature limitation Upper Limit of Temperature Use by last day of the month Electronic Waste Authorized Representative in the European Community Laser R...

Страница 6: ......

Страница 7: ...2454 9141 in the U S A U S A 1 781 899 0417 outside the U S A Web www novabiomedical com REP EC Authorized Representative Nova Biomedical UK Telephone 44 1928 704040 Innovation House Fax 44 1928 79679...

Страница 8: ...al 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 B t Sigma 3 avenue du Canada 1er tage Les Ulis courtabo...

Страница 9: ...3 1 Manual Calibrations 2 8 3 Sample Analysis 3 1 3 1 Analyzing Patient Samples 3 1 3 1 1 Analyzing Syringe Samples 3 1 3 1 2 Utilizing the Luer Station 3 3 3 1 3 Analyzing Sample Blood Collection Tu...

Страница 10: ...6 3 1 Flushing the Sample Probe 6 4 A Appendix A 1 A 1 Specifications A 1 A 1 1 Analytical Specificity A 3 A 2 Analytical Performance Studies A 5 A 3 Calibrator Cartridge A 22 A 3 1 Traceability Cali...

Страница 11: ...ded When performing maintenance and troubleshooting procedures also use protective eyewear This section introduces the Prime CCSAnalyzer and covers requirements testsperformed procedurallimitations cl...

Страница 12: ...s 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 t...

Страница 13: ...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 au...

Страница 14: ...stallation and Use This section covers the installation requirements and assemblyproceduresfortheStatProfilePrimeCCSAnalyzer Priortouseoftheanalyzer operatorsshouldbefamiliarwith Chapter 2 Operation a...

Страница 15: ...nder 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 flat surface 1 5 Intended Use Tests Perfo...

Страница 16: ...to patient temperature Bicarbonate level HCO3 Total Carbon Dioxide TCO2 Base Excess of the blood BE b Base Excess of extracellular fluid BE ecf Standard Bicarbonate Concentration SBC Total Carbon Diox...

Страница 17: ...igh potassium levels Cl Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis iCa Ionized Calcium measurement...

Страница 18: ...y reflect 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...

Страница 19: ...concentrations of 20 I U per mL to over 100 I U per mL may result Excesssodiumheparinmayelevatesodiumresults Liquid or dry heparin when present in excess may cause errors Ensure blood collection devi...

Страница 20: ...1 10 Prime CCS Instructions for Use Manual...

Страница 21: ...Started 2 Getting Started 2 Getting Started The Stat Profile Prime CCS Analyzer is pictured below Figure 2 1 Nova Stat Profile Prime CCS 1 Touch screen Display 2 Printer 3 Sampler 4 Door Front Panel 2...

Страница 22: ...gure 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 Ref...

Страница 23: ...play on the analyzer s screen After successfully completing the POST the Home screen displays with Initializing During initialization an internal diagnosticsequenceisrun theSensorCardlife thecalibrato...

Страница 24: ...t 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 Tim...

Страница 25: ...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 analy...

Страница 26: ...ssed to display screen two From the System Menu you can also navigate to the Setup Menu The find results icon of the Menu Bar will display all the patient results stored on the analyzer The QC icon wi...

Страница 27: ...calibration is performed at regular intervals to monitor the sensorcard sperformancebetweeneach2 pointcalibration If a calibration error occurs an alert is shown to notify the operator and the test b...

Страница 28: ...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...

Страница 29: ...nalyzing Patient Samples BeforerunningapatientsampleverifytheanalyzerisReady to perform an analysis and that all the desired analytes are available for selection If necessary refer to Chapter 2 for ad...

Страница 30: ...art icon to begin the analysis 4 Ifprompted enter all Required I n f o r m a t i o n and press Start o n c e moretobegin the analysis Figure 3 3 Sample Information Screen 5 Prepare the sample for anal...

Страница 31: ...e analyzer instead of manually positioning the sample probe in the sample When utilizing the leur station Nova recommendsusingtheNovaSyringeClotCatchertoensure that the sample is positioned correctly...

Страница 32: ...r logging into the analyzer 1 Selectthesyringe iconfromthecontainer drop down list 2 SelectthedesiredTestPanelfromthedrop downlist or select one or more analytes to create a Custom Panel Figure 3 7 Re...

Страница 33: ...the analysis Figure 3 9 Sample Information Screen 6 Press the Aspirate icon to aspirate sample into the analyzer The sample probe will retract automatically once sufficient sample has been aspirated...

Страница 34: ...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 Ifrequired enterorscanyourPasswordthenpress Figure 3 11 Op...

Страница 35: ...Required I n f o r m a t i o n and press Start o n c e more to begin the analysis Figure 3 13 Sample Information Screen 5 Prepare the sample for analysis mix well then position the sample over the pr...

Страница 36: ...printed or transmitted Figure 3 15 Sample Information Screen 3 1 4 Analyzing Sample from a Capillary Tube From the Home screen login if you are prompted to login 1 Press the Login icon to log into the...

Страница 37: ...ontainer and Panel Drop down List 3 Press Start icon to begin the analysis 4 Ifprompted enter all Required I n f o r m a t i o n and press Start o n c e more to begin the analysis Figure 3 18 Sample I...

Страница 38: ...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...

Страница 39: ...played with a Red background when a sample exceeds the high Alert range Figure 3 21 Blood Results Screen Use the Page Up and Page Down buttons to scroll through additional pages of result screens The...

Страница 40: ...mation 3 2 1 Analyzing Internal 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 pr...

Страница 41: ...ntrol 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 resul...

Страница 42: ...Ifrequired enterorscanyourPasswordthenpress Figure 3 22 Operator ID Screen and Operator Password Screen If login is not required or after logging into the analyzer 1 From the Home Screen press the QC...

Страница 43: ...mple has been aspirated into the analyzer Figure 3 24 External Control to Probe 9 Once the analysis is complete press Save to keep the QC results or press Delete to discard the QC results 3 2 3 Analyz...

Страница 44: ...e Proficiency 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 Thes...

Страница 45: ...p Tubing WARNING Blood samples and blood products are potential sources of infectious agents Handle all blood products and flow path components waste line probe sensor module etc with care Gloves and...

Страница 46: ...r WARNING When the calibrator cartridge or control cartridge is removed keep your fingers and hands away from the back of the cartridge compartment There are sharp needles that can cause injury and th...

Страница 47: ...4 3 Replacing Calibrator Cartridge and Control Cartridge 4 2 1 Change Calibrator Cartridge 1 Press the Tool Box icon 2 FromtheSystemMenu presstheChangeCalibrator Cartridge and wait for pump to stop 3...

Страница 48: ...ront retaining lip 5 Close door press the Calibrate icon 4 3 Change Sensor Card 1 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...

Страница 49: ...uld be replaced at intervals prescribed inthemaintenancelog Replacethetubingthatgoesaround the pump as follows Figure 5 1 Pump Tubing 1 From the Home screen press the Tool Box icon 2 FromtheSystemMenu...

Страница 50: ...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 t...

Страница 51: ...e probe by gently pulling Figure 5 4 Removing Capillary Adapter NOTE Capillary Adapter is usually changed with the Calibrator Cartridge since a new capillary adapter comes with the cartridge 3 Disconn...

Страница 52: ...g Probe S line and Cable of Air Detector 6 Place new Probe assembly until it clicks into place 7 Replace the capillary adaptor back onto the probe 8 Reconnect the S line to the Reference Sensor 9 Reco...

Страница 53: ...nuselecttheChangeReference 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 first Only...

Страница 54: ...left of the sensor to push the sensor to the right and off Figure 5 9 Slide the Reference Sensor Off to the Right 8 Take a new sensor by the arm and slide it back onto the analyzer from right to left...

Страница 55: ...acement 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 Feed paper past the cover Then cl...

Страница 56: ...ual 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 Figure 5 11 Replacing the Safety Sample Port Docking...

Страница 57: ...ures use the most logical and direct steps to resolve the error code The solutionsaresetupinablockformatthatlistsgroupsofsteps to perform in order to restore operation The steps are also organized to...

Страница 58: ...at fluid 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 flow test and sensor cartridge reference sensor and sa...

Страница 59: ...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 Cartridge 1 Press the...

Страница 60: ...ir detector s sample line from the Reference Sensor module using the removal tool attached to the door 3 Usethesyringewithattachedtubingtoflushdistilled water through the S line and out the Sample Pro...

Страница 61: ...ce information and warranty for the Stat Profile Prime CCS Analyzer A 1 Specifications Measurement Range pH 6 500 8 000 PCO2 3 0 200 mmHg 0 4 26 7 kPa PO2 0 800 mmHg 0 0 106 7 kPa Hct 12 70 Na 80 200...

Страница 62: ...b 0 1 mmol L SBC 0 1 mmol L O2Ct 0 1 mL dL P50 0 1 mmHg 0 1 kPa With entered FiO2 A 0 1 mmHg 0 1 kPa AaDO2 0 1 mmHg 0 1 kPa a A 0 1 PO2 FiO2 0 1 mmHg 0 1 kPa Acceptable Samples Whole Blood heparinized...

Страница 63: ...terfere with the test methodology The followingtablerepresentssubstancesthatweretestedwithout demonstrating a clinically significant effect on test results Interfering Substance Highest Concentration...

Страница 64: ...de 15 0 mmol L Na Cl iCa Maltose 13 0 mmol L Glu Lac Mannose 10 0 mmol L Glu Lac Perchlorate 1 0 mmol L iCa Potassium Chloride 5 0 mmol L addition pH PCO2 PO2 iCa Potassium Thiocyanate 2 064 mol L Cl...

Страница 65: ...ance Studies Three Stat Profile Prime CCS analyzers were compared to 2 Stat Profile pHOx Ultra Analyzers in a laboratory setting by healthcare professionals The protocol consisted of withinrunprecisio...

Страница 66: ...f100wholebloodspecimenswereanalyzedfor eachparameterincapillarycollectiontubes Eachspecimen was analyzed one time from a capillary container on each Stat Profile Prime CCS analyzer and then immediatel...

Страница 67: ...A 7 Appendix A Appendix A...

Страница 68: ...A 8 Prime CCS Instructions for Use Manual...

Страница 69: ...A 9 Appendix A Appendix A...

Страница 70: ...A 10 Prime CCS Instructions for Use Manual...

Страница 71: ...A 11 Appendix A Appendix A...

Страница 72: ...0 9889 2 170 24 12 68 1 0007 0 6236 0 9871 3 164 19 13 70 1 0207 0 9936 0 9895 Na 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...

Страница 73: ...0 0485 0 9963 2 100 14 66 0 9863 0 6676 0 9960 3 100 13 67 1 0161 0 4917 0 9950 Na 1 100 85 0 198 1 0 9995 0 1711 0 9978 mmol L 2 100 85 0 192 0 1 0016 0 4681 0 9988 3 100 85 0 194 7 0 9926 0 9061 0 9...

Страница 74: ...using 3 different quality control materials Stat Profile Prime Quality Control Level 1 Stat Profile Prime Quality Control Level 2 Stat Profile Prime Quality Control Level 3 Within Run Precision Perfo...

Страница 75: ...4 0 4 CV 0 5 0 8 0 6 0 6 Hct Mean 38 38 38 38 SD 0 5 0 4 0 3 0 5 Na Mean 158 1 157 5 158 7 158 1 mmol L SD 0 1 0 4 1 4 0 9 CV 0 1 0 2 0 9 0 6 K Mean 5 80 5 84 5 81 5 82 mmol L SD 0 00 0 02 0 03 0 03...

Страница 76: ...1 4 0 3 0 9 CV 0 5 1 3 0 3 0 9 Hct Mean 55 55 55 55 SD 0 5 0 3 0 3 0 4 Na Mean 140 2 140 1 140 0 140 1 mmol L SD 0 1 0 2 0 6 0 4 CV 0 1 0 1 0 5 0 3 K Mean 3 84 3 81 3 80 3 82 mmol L SD 0 02 0 01 0 02...

Страница 77: ...3 1 8 CV 0 5 0 4 0 2 1 3 Hct Mean 69 68 69 69 SD 0 5 0 5 0 5 0 5 Na Mean 120 4 120 5 120 2 120 4 mmol L SD 0 1 0 3 0 3 0 3 CV 0 1 0 2 0 3 0 2 K Mean 1 88 1 86 1 86 1 86 mmol L SD 0 01 0 01 0 00 0 01 C...

Страница 78: ...rameter 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 WholeBlood 2...

Страница 79: ...0 07 0 29 0 42 1 83 Linearity Std 1 76 6 240 0 46 0 60 2 22 2 90 Linearity Std 2 61 4 240 0 19 0 31 1 32 2 16 Linearity Std 3 41 0 240 0 36 0 88 0 59 1 44 Linearity Std 4 25 3 240 0 06 0 23 0 51 2 02...

Страница 80: ...ecision SD St Total Imprecision CV QC Level 1 158 3 240 0 56 0 35 0 68 0 43 QC Level 2 140 1 240 0 12 0 09 0 25 0 18 QC Level 3 120 2 240 0 08 0 07 0 18 0 15 Linearity Std 1 89 7 240 0 45 0 50 0 56 0...

Страница 81: ...recision CV QC Level 1 131 5 240 0 57 0 43 2 30 1 75 QC Level 2 103 0 240 0 72 0 70 1 52 1 48 QC Level 3 86 1 240 0 27 0 32 1 38 1 60 Linearity Std 1 73 5 240 0 15 0 21 1 26 1 71 Linearity Std 2 82 6...

Страница 82: ...Linearity Std 3 2 53 240 0 022 0 87 0 07 2 88 Linearity Std 4 6 59 240 0 056 0 85 0 26 3 92 Linearity Std 5 10 51 240 0 086 0 82 0 45 4 26 A 3 Calibrator Cartridge The concentrations of the internal...

Страница 83: ...______________________________________________________ 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 arter...

Страница 84: ...hia PA W B Saunders Co 3 Kost G T 1993 The Significance 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 andAbrams B...

Страница 85: ...Cartridge CCS 300 Sample 52863 Prime Calibrator Cartridge CCS 400 Sample 53466 Prime Calibrator Cartridge CCS 500 Sample 53467 Prime Calibrator Cartridge CCS 600 Sample 53468 Prime Calibrator Cartrid...

Страница 86: ...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 prev...

Страница 87: ...ity coefficient 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...

Страница 88: ...pH The pH of an unknown sample is calculated using the following equation Estd C Ex pH Estd C Ex pHstd C Equation 6 Slope Estd C Ex where Slope Equation 7 pHstd C pHstd D Principle of pH Measurement p...

Страница 89: ...the membrane into a thin layer of bicarbonate buffer in response to partial pressuredifference Thissolutionthenbecomesequilibrated with the external gas pressure of the fluid in contact with the outer...

Страница 90: ...the oxygen molecules are reduced at the cathode consuming 4 electrons for every molecule of oxygen reduced This flow of electrons is then measured by the sensor and is directly proportional to the pa...

Страница 91: ...f electrons at the surface of the platinum sensor is proportional to the glucose concentration of the sample B 1 7 Lactate LactatemeasurementisbasedonthelevelofH2O2produced during the enzymatic reacti...

Страница 92: ...he 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 pH PCO2 and PO2 sample values...

Страница 93: ...re measured pK 6 091 0 0307 solubility coefficient 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 Carbo...

Страница 94: ...ProfilePrimeCCS Analyzer hemoglobin estimation from samples with Red cell dyscrasia or hemoglobinopathies may vary significantly from hemoglobin measured by cyanmethemoglobin method Base Excess of Blo...

Страница 95: ...BC 24 5 0 9Z Z Z 8 0 004 0 00025 Hb Equation 21 where Z BE B 0 19 Hb 100 SO2 100 Hb Thehemoglobinvaluewhichismeasured manually entered or is the 14 3 g dL default value Base Excess Extracellular Fluid...

Страница 96: ...22393 _________ 1 39 mL of O2 per gram of Hb Equation 23 64458 therefore O2Ct 1 39 Hb SO2 100 0 0031 PO2 Equation 24 where 0 0031 is the solubility coefficient of O2 On the analyzer hemoglobin can be...

Страница 97: ...ractioninspiredoxygen asapercent Temperature corrected gas value Arterial Alveolar Oxygen Tension Gradient AaDO2 The arterial alveolar oxygen tension gradient is a useful index of gas exchange within...

Страница 98: ...takes up carbon dioxide Thequantityofoxygendonateddependson2factors The speed of blood flow The consumption by tissues The first factor can be detected from the cardiac output and the second depends...

Страница 99: ...0 uncorrected PO2 SO2 100 SO2 0 37Equation 30 For 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 1 875 P50 uncorrected 26 902 exp 1...

Страница 100: ...an 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 fo...

Страница 101: ...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 Office 2 National Committee for C...

Страница 102: ...B 16 Prime CCS Instructions for Use Manual...

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