NIPRO Diagnostics True Metrix Pro Manual Download Page 62

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Appendix E

Proficiency Testing

Information

Summary of Contents for True Metrix Pro

Page 1: ...demarks of Nipro Diagnostics Inc MKT0523 Rev 2 TRUE METRIX is intended for self monitoring blood glucose only and not for multiple patient use Only TRUE METRIX PRO is intended for multiple patient use...

Page 2: ...g Meter Setup Quality Control Testing 16 22 Meter Setup Quality Control Testing Quality Control Testing Data Form Blood Glucose Testing 23 24 Blood Glucose Testing Diabetes Data Management Capabilitie...

Page 3: ...Introduction...

Page 4: ...g physiological and pharmacological interfering substances Performing the blood glucose testing process using various specimens Reviewing processes for Quality Control Testing product maintenance syst...

Page 5: ...UE METRIX PRO Blood Glucose Monitoring System is intended for the quantitative determination of glucose in human whole blood taken from the fingertip or forearm capillary or from the vein venous The s...

Page 6: ...lose to sources of strong electromagnetic radiation as these may interfere with the proper operation Healthcare professionals should adhere to standard precautions and disinfection procedures when han...

Page 7: ...y CR2032 non rechargeable Battery Life Approximately 1 000 tests or 1 year Automatic Shut Off After two minutes of non use Weight 1 66 ounces Size 3 44 x 2 16 x 0 69 Memory Size 500 glucose and contro...

Page 8: ...owing requirements Complete the Clinical Laboratory Improvement Amendments of 1988 CLIA Application for Certification Form CMS 116 The form and instructions on completing and mailing the form are foun...

Page 9: ...System Components...

Page 10: ...TRUE METRIX PRO System Comprehensive Resource Guide GDH FAD Enzyme System Components 6 System Components Test Strips Test Strip Vial Control Solution Meter...

Page 11: ...ime when viewing results and Averages in Memory Button Turn meter on to view Average values to view results in Memory to access Meter Set Up and turn on Event Tags in Meter Memory Button Increase numb...

Page 12: ...me date for convenient tracking and trending of data Strip Release Button safely releases test strip without user coming in contact with contaminated test strip Test strip guide for easy test strip in...

Page 13: ...rom Memory Test Result Control Symbol Battery Symbol Alternate Site ALT Symbol Drop Symbol Apply blood or control solution Temperature Symbol Test Reminder Symbol Ketone Test Alert Symbol Units of Mea...

Page 14: ...f results Testing outside of specified operating temperature range is marked by an error code eliminating incorrect results CORRECT Hematocrit Temperature Variables Employs a Proprietary Dynamic Adapt...

Page 15: ...lution Soluci n de Control Level Nivel 3 3 mL R5NPD10 Rev 3 Manufactured for Fabricado para Fort Lauderdale FL 33309 USA For in vitro diagnostic use only Store at temperature between 36 86 F 2 30 C DO...

Page 16: ...Clinical Information...

Page 17: ...is recognized as the standard in many countries Clinical data obtained by healthcare professionals on the TRUE METRIX PRO Blood Glucose Monitoring System exceeded the minimum accuracy criteria for ISO...

Page 18: ...06 SD mg dL 1 6 3 8 10 3 CV 4 8 3 6 3 4 The TRUE METRIX PRO System was also tested by healthcare professionals at a research center The data was compared to parallel results obtained on a Yellow Sprin...

Page 19: ...luctuate If the patient is ill or under stress If the glucose result may be low or high If symptoms of low or high glucose levels are not evident Alternate site forearm testing should not be used to c...

Page 20: ...ic Concentrations Concentrations Determined That Will Affect Meter Glucose Results Acetaminophen 2 0 mg dL 30 mg dL Acetone 2 0 mg dL 20 mg dL Ascorbic Acid 1 5 mg dL 6 0 mg dL 2 mg dL Bilirubin 1 0 m...

Page 21: ...Meter Setup Quality Control Testing...

Page 22: ...press or Button to select the month Press Button to set 5 The day number ashes To change press or Button to select the day Press Button to set 6 The year ashes To change press or Button to select the...

Page 23: ...up choices are saved Note If Test Reminders are set the Alert Symbol appears in all Displays If battery dies or is replaced Ketone Test Alert and Test Reminders may have to be reset Set Event Tags Ke...

Page 24: ...ect errors that may occur due to test system errors product defects adverse environmental conditions and variance in operator performance Ongoing Quality Control Testing is also used to detect any per...

Page 25: ...ortant to perform Control Tests with more than one level of control solution to assure that the system is working properly and testing technique is good Three levels of TRUE METRIX Control Solution Le...

Page 26: ...ote If test strip has been out of the vial too long before testing an error message appears upon insertion of the test strip into the meter Release and discard old test strip Use new test strip for te...

Page 27: ...t result is outside range test again If result is still outside range the system should not be used for testing blood Call for assistance 12 After result is shown Strip Release Button ashes Hold meter...

Page 28: ...the vial label has passed whichever comes first On TRUE METRIX PRO Control Solution bottle label write date bottle opened Discard bottle if either 3 months after opening or after EXP date printed on t...

Page 29: ...Blood Glucose Testing...

Page 30: ...nd put on a new pair of gloves 2 Select subject s fingertip Clean area with soap and warm water rinse or use an approved disinfectant to clean the area Dry thoroughly Note Do not squeeze the fingertip...

Page 31: ...d allow blood to be drawn into test strip Remove Sample Tip from blood drop immediately after the meter beeps and dashes appear across meter Display Note If meter does not beep and show dashes in the...

Page 32: ...Diabetes Data Management Capabilities...

Page 33: ...e no Average values three dashes are displayed for 7 14 and 30 day Averages View Results Memory stores 500 results When the Memory is full the oldest result is replaced with the newest result 1 Press...

Page 34: ...w various lifestyle and behavior choices may be affecting their blood glucose levels With this information and your expertise patients are empowered to make better choices in daily self management Hom...

Page 35: ...lable in the following languages that are all available on one DVD language preference is chosen during installation process English Spanish French Portuguese Croatian HL7 Interface Overview The HL7 i...

Page 36: ...x 768 or higher Minimum Structured Query Language SQL Server 2005 2008 or 2012 Express Edition Standard or Enterprise Edition recommended for larger facilities TRUEmanager Home Version Minimum Hardwa...

Page 37: ...System Maintenance...

Page 38: ...d Remove test strip Re insert test strip fully into meter Test strip error Remove test strip Repeat with new test strip Dead or no battery Replace battery Battery in backwards Check placement of batte...

Page 39: ...top If error persists call for assistance Meter Error Call for assistance Test Strip Error Very high blood glucose result higher than 600mg dL Retest with new Test Strip If error persists call for as...

Page 40: ...meter does not turn on check that battery was installed properly If not remove and reinsert battery and turn meter on by pressing Button Call for assistance if problem persists Battery might explode...

Page 41: ...issing Buttons are hard to push on the meter or do not work Unable to insert test strip into Test Port Automatic Self Test gives an error message If system is to be used on multiple patients cleaning...

Page 42: ...OT FREEZE Allow System to sit at room temperature for 10 minutes before testing TRUE METRIX PRO Test Strips Store test strips in original vial only Do not transfer old test strips into new vial or sto...

Page 43: ...Training Program...

Page 44: ...Guide and all product Instructions for Use Test Strip Control Solution Owner s Booklet 3 Complete the Training Checklist and Post Test included in this Comprehensive Resource Guide TRUE METRIX PRO Sys...

Page 45: ...session for facility personnel Product Training Agenda example Materials Checklist Training Checklist TRUE METRIX PRO System Comprehensive Resource Guide GDH FAD Enzyme Training Program 35 During the...

Page 46: ...e for blood glucose monitoring 7 Interpreting Blood Glucose Results 5 minutes Facility Policy and Procedure 8 Interpreting Meter Display Messages Troubleshooting 5 minutes Technical Overview located i...

Page 47: ...owing ____ Use of the TRUE METRIX PRO System in a clinical setting ____ System specifications ____ Limitations and critical safety information including that the TRUE METRIX PRO System must not be use...

Page 48: ...fingertip should be used instead of forearm ____ Demonstrates the ability to obtain a sufficient amount of blood for testing from both a fingertip and forearm ____ Understands facility s procedure on...

Page 49: ...X PRO Blood Glucose Monitoring System for the first time in a facility __________True __________False 2 The TRUE METRIX PRO System can be used on neonates __________True __________False 3 Quality Cont...

Page 50: ...g b Identify drug therapy ies patient may be on or starting c Identify and use appropriate point of care blood glucose testing system d All of the above 3 The TRUE METRIX PRO System utilizes the follo...

Page 51: ...he vial was left open for too long c The cap was left off the control solution bottle d The open date written on the control solution bottle or test strip vial has passed e All of the above 8 Forearm...

Page 52: ...tten Test Answer Key True or False Q 1 True Q 2 False Q 3 True Q 4 False Q 5 False Q 6 True Q 7 False Multiple Choice Q 1 e All of the above Q 2 d All of the above Q 3 b GDH FAD Q 4 h a and e Q 5 d Me...

Page 53: ...References...

Page 54: ...on Poses Risk for Transmitting Bloodborne Pathogens Electronic Version Retrieved February 22 2012 from http www cdc gov injectionsafety Fingerstick DevicesBGM html 3 International Organization for Sta...

Page 55: ...Appendix A Clinical Studies Note Available for download at www niprodiagnostics com...

Page 56: ...Appendix B Product Labeling Note Your Distributor will provide copies of product labeling Owner s Booklet Test Strip Instructions for Use and Control Solution Instructions for Use...

Page 57: ...Appendix C Safety Data Sheets...

Page 58: ...ca Gel polypropylene polyethylene Test strips Glucose dehydrogenase Flavin adenine dinucleotide GDH FAD Aspergillus sp mediators buffers and stabilizers Test strip Box and Package Insert Paper Section...

Page 59: ...TRUE METRIX Control Solution Levels 1 2 and 3 Section 2 Composition Information on Ingredients Bottle Polypropylene polyethylene Control Solution Water d glucose buffers viscosity enhancing agents sal...

Page 60: ...Appendix D Forms...

Page 61: ...ee number on Meter label below the bar code Note any problems in Troubleshooting section below Test Strips Control Solution Level __________ Control Solution Level __________ Date Time Date Opened Dat...

Page 62: ...Appendix E Proficiency Testing Information...

Page 63: ...w your results compare to other TRUE METRIX PRO System users If your proficiency sample results are not within acceptable limits of other TRUE METRIX PRO users results then you should investigate poss...

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