background image

2.   Check dates on test strip vial  

being used. Do not use test  

strips 4 months past written  

opened date or after date printed  

on test strip vial label, whichever  

comes first.

3.   Remove one test strip from vial.  

Close vial immediately. Use test  

strips quickly after removal from vial.

  

Note:  Test strips that have been left out of the vial too 

long before use will give an error message. If 

error message displays, release and discard the 

old test strip and test with a new test strip.

4.   With meter off, insert test strip Contact End (blocks 

facing up) into Test Port. Meter turns on. Keep test 

strip in meter until testing is finished. 

 

To mark test as alternate site (forearm) result, 

press “     ” Button. ALT Symbol appears in Display. 

Press “     ” Button to remove ALT Symbol.

  

Note:  Removing the test strip before  

the result is displayed cancels  

the test. An error message  

appears and result is not stored 

in memory. Retest with a new test  

strip and do not remove the  

test strip from the meter before  

the result is displayed.

5.   Wait until the Drop Symbol appears in  

the Display.

6.   Obtain the blood sample. Allow drop 

to form (refer to step one).

TRUE METRIX

®

 PRO System Comprehensive Resource Guide (GDH-FAD Enzyme)

Blood Glucose Testing  24

Blood Glucose Testing 

cont.

7.   With test strip still in meter, touch Sample 

Tip of test strip to top of blood drop from 

sample obtained in Step 1 and 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 Display soon after touching the sample 

to the Sample Tip, release and discard the 

test strip. Repeat the test with a new test 

strip and a new sample. If problem persists, 

see the Troubleshooting section of this 

Resource Guide.

8.   After the test is finished, result is 

displayed. The Strip Release Button 

flashes. Record result as required by 

your facility.  

9.   Hold the meter with the test strip  

pointing down. Press the Strip Release  

Button to release and discard the test  

strip into the appropriate container.  

Meter turns off. Result is stored in  

Memory with date and time.

10.  Discard all biohazard materials into  

appropriate container. Wash hands  

after taking off gloves.

Used test strips and lancets are considered 

biohazardous. Dispose used test strips and 

lancets in approved biohazard container. 

11.  Record the result as required by your facility.

   Note:  If blood glucose test result is greater than 240 

mg/dL and the Ketone Test Alert is turned on, the 

Ketone Test Alert Symbol appears in the Display 

with the result. Test ketones per the treatment 

plan. The Ketone Test Alert may be turned on or 

off during Setup.

When a Ketone Test Alert Symbol appears, 

it does not mean that ketones have been 

detected in patient’s blood. The Ketone Test 

Alert is a reminder to perform a ketone test 

as prescribed in the treatment plan.

May 30, 2017

Drop Symbol

Meter Testing

Содержание True Metrix Pro

Страница 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...

Страница 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...

Страница 3: ...Introduction...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 9: ...System Components...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 16: ...Clinical Information...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 29: ...Blood Glucose Testing...

Страница 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...

Страница 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...

Страница 32: ...Diabetes Data Management Capabilities...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 37: ...System Maintenance...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 43: ...Training Program...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 53: ...References...

Страница 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...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 60: ...Appendix D Forms...

Страница 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...

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

Страница 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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