NIPRO Diagnostics TRUE METRIX, Owner'S Booklet

Page 1: ...tation English or Spanish 1 800 803 6025 www niprodiagnostics com 2015 Nipro Diagnostics Inc TRUE METRIX and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics Inc RE4NPD03 Rev 6 Owner s Booklet Manufactured by Fort Lauderdale FL 33309 U S A SELF MONITORING BLOOD GLUCOSE SYSTEM ...

Page 2: ...ting 100 mg dL 2 hours after a meal 140 mg dL For quick reference only not intended as a substitute for complete instructions Please read entire Owner s Booklet and product Instructions for Use before testing INSERT TEST STRIP 1 2 APPLY BLOOD SAMPLE 2 simple steps SELF MONITORING BLOOD GLUCOSE SYSTEM ...

Page 3: ...n fresh capillary whole blood samples drawn from the fingertip or forearm The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not to be shared The TRUE METRIX Self Monitoring Blood Glucose System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home as an aid to monitor the effectiveness of diabetes cont...

Page 4: ...ng Test Strips to check that the meter and the test strip are working together properly and the test is performing correctly Importance of Blood Glucose Monitoring The more you know about diabetes the better you will be able to care for yourself A Doctor or Healthcare Professional determines how often you should test and what your target ranges are for blood glucose results Having most blood gluco...

Page 5: ...lternative site forearm testing should not be used for insulin dose calculations Use only TRUE METRIX Self Monitoring Test Strips and TRUE METRIX Control Solution with the TRUE METRIX Self Monitoring Meter Remove only one test strip at a time from test strip vial Recap vial immediately NEVER reuse test strips NEVER wipe test strips with water alcohol or any cleaner DO NOT attempt to remove blood o...

Page 6: ...fter cleaning and disinfecting 2 3 Cleaning and disinfecting the lancing device and the meter destroys most but not necessarily all blood borne pathogens Wash your hands thoroughly with soap and warm water before and after handling the meter lancing device lancets or test strips as contact with blood presents an infection risk If the meter is being operated by a second person who provides testing ...

Page 7: ...oms may be trembling sweating intense hunger nervousness weakness and trouble speaking High blood glucose hyperglycemia symptoms may be intense thirst a need to urinate often dry mouth vomiting and headache Do not use for diagnosis of or screening of diabetes or for neonatal use Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock Inaccura...

Page 8: ...ing a Blood Sample 21 How to Test Blood 25 TRUE METRIX System and Laboratory Testing 29 System Out of Range Warning Messages 30 Meter Set Up Set Time and Date 31 Set Event Tags Ketone Test Alert and Test Reminders 33 Meter Memory View Averages 7 14 and 30 day 36 View Results 37 Care Cleaning Disinfecting and Troubleshooting Caring for TRUE METRIX 38 Changing Battery 44 Troubleshooting 45 Display M...

Page 9: ...gs to mark results if feature on Button Turn meter on to view Average values to view results in Memory to access Meter Set Up to turn on Event Tags in Meter Set Up Button Increase numbers in Meter Set Up remove ALT Symbol move forward by date time when viewing results and view Averages in Memory scroll through Event Tags to mark results if feature on 7 Top of Meter 1 3 2 ...

Page 10: ...facing up Strip Release Button Releases test strip after testing for disposal Battery Door Use one non rechargeable 3V lithium battery CR2032 positive side up see Changing Battery Meter Label Contains serial number of meter Data Contacts Connects meter with computer for data upload 8 2 1 Front of Meter 3 4 5 Back of Meter 6 ...

Page 11: ...or 30 day Average 6 Test Result 7 Control Symbol 8 Battery Symbol 9 Alternate Site ALT Symbol 10 Drop Symbol Apply blood or control solution 11 Temperature Symbol 12 Test Reminder Symbol 13 Ketone Test Alert Symbol 14 Unit of Measure Note Factory set to mg dL cannot be changed by user 3 4 2 1 7 6 5 8 9 10 11 12 13 14 ...

Page 12: ... Tip to blood or control solution drop Sample Placement Correct Incorrect Allow sample drop to be drawn into Sample Tip until test ing begins meter beeps and dashes move across Display Do not smear or scrape drop with test strip Do not apply more sample to test strip after testing begins Do not apply blood or control solution to top of test strip Do not insert Sample Tip with sample into Test Port...

Page 13: ...n vial label has passed whichever comes first Caution Use of test strips or control solution past the Expiration Dates may give incorrect test results Discard out of date products and test with new products Control Test Range Range of numbers in which Control Test result must fall to assure the system is working properly Note Examples only Do not represent actual Control Test ranges 11 Test Strip ...

Page 14: ...el Discard bottle if either 3 months after first opening or date printed next to EXP on bottle label has passed whichever comes first Control Solution Level 1 2 or 3 We recommend testing at least 2 levels of control solution Contact 1 800 803 6025 for assistance with obtaining different levels of control solution 1 2 3 May 30 2015 Control Solution Control ...

Page 15: ...n a test strip is inserted into the Test Port or when Button is pressed see Memory and Meter Set Up Meter turns off when the test strip is released or removed from the meter Button is pressed or after 2 minutes of non use Turning the Ketone Test Alert on sets a reminder to check your ketones per your treatment plan when a blood glucose result is over 240 mg dL Test Reminders are set like an alarm ...

Page 16: ...result Sick test was taken when sick Other any other reason that the test is unique or different in some way example stress drinking alcohol In your logbook note the reason that the test result was tagged Seeing a result with an Event Tag in the meter Memory reminds you that there is more about this test result in your log book Tagging results helps track the effect specific events may have on you...

Page 17: ...d correctly into the Test Port Insert a test strip into the Test Port The meter is working properly if the full Display appears then the time appears in the upper part of the Display and then the Drop Symbol begins to blink If an error message appears in the Display the meter will not perform a test See Troubleshooting or call 1 800 803 6025 Caution If any segments are missing in the Display when ...

Page 18: ...posed to extreme heat or cold or humidity Whenever a check on performance of the system is needed If meter damage is suspected meter was dropped crushed wet etc Note It is important to perform Control Tests with more than one level of control solution Three levels of TRUE METRIX Control Solution are available for Control Tests Call 1 800 803 6025 for assistance in obtaining different levels of con...

Page 19: ...EXP on label test strips 4 months after first opening or date next to EXP on labels Discard expired products and use new products 2 Allow control solution vial of test strips and meter to adjust to room temperature Write date first opened on both control solution bottle label and test strip vial label when using for the first time 3 Gently swirl or invert control solution bottle to mix DO NOT SHAKE...

Page 20: ...is finished Note If test strip is removed before testing is finished an error message appears Release and discard old test strip Use new test strip for testing 7 With cap removed turn control solution bottle upside down Squeeze one drop of control solution onto a clean tissue Wipe off bottle tip and discard tissue 8 Gently squeeze a drop of control solution onto a small piece of unused aluminum foil...

Page 21: ...st strip Repeat test with new test strip If problem persists see Troubleshooting 11 Compare meter result to Control Test range printed on test strip vial label for level of control solution you are using If result is in range System can be used for testing blood If result does not fall within range repeat test using a new test strip Note Control Test result shows the Control Symbol in the Display ...

Page 22: ...n Strip Release Button flashes Hold meter with test strip pointing down Press Strip Release Button to release and discard test strip into appropriate container Meter turns off Note Removing test strip before result displays cancels the test An error message appears and the result is not stored in Memory Retest with a new test strip and do not remove before result is displayed 20 ...

Page 23: ... most but not necessarily all blood borne pathogens Wash your hands thoroughly with soap and warm water before and after handling the meter lancing device lancets or test strips as contact with blood presents an infection risk If the meter is being operated by a second person who provides testing assistance the meter and lancing device should be disinfected prior to use by the second person It is ...

Page 24: ...Prepare fingertip by washing hands in warm soapy water Rinse well Dry thoroughly 2 Place end of lancing device equipped with a lancet against tip of finger Lance fingertip 3 Set lancing device aside To help blood drop form lower hand to waist level gently massaging finger from palm to fingertip Allow blood drop to form before attempting to apply to the test strip Apply sample to test strip Sample Tip 4...

Page 25: ...apidly or your routine results are often fluctuating If you are ill or under stress If your forearm test results do not match how you feel If your blood sugar may be low or high If you do not notice symptoms when blood sugar is low or high 1 Select area to be lanced Wash with soap and warm water rinse and dry thoroughly 2 Rub area vigorously or apply a warm dry compress to increase blood flow 3 Plac...

Page 26: ...vice The used lancet may be biohazardous Please discard it carefully according to your healthcare provider s instructions Caution The used lancet may be biohazardous Please discard it carefully according to your healthcare provider s instructions ...

Page 27: ...oval from vial 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 alternative site forearm result press Button ALT Symbol appears in Display Press Button to remove ALT Symbol Wait until Drop Symbol appears in Display Note If test strip has been out of the vial too long before testing an err...

Page 28: ...lood to be drawn into test strip Remove test strip from blood drop immediately after the meter beeps and dashes appear across the Display Note If meter does not begin testing soon after touching drop to test strip discard test strip Repeat test with new test strip and new blood drop If problem persists see Troubleshooting Dashes appear across Display to show meter is testing ...

Page 29: ...a meal Exercise test was taken during or after exercise Medications medication taken may have affected test result Sick test was taken when sick Other any other reason that the test is unique or different in some way example stress drinking alcohol In your logbook note the reason that the test result was tagged Seeing a result with an Event Tag in the meter Memory reminds you that there is more ab...

Page 30: ...Memory with date and time Note Removing test strip before result displays cancels the test An error message appears and result is not stored in Memory Retest with a new test strip and do not remove before result is displayed Caution The used lancet and test strip may be biohazardous Please discard them carefully according to your healthcare provider s instructions ...

Page 31: ...Blood Glucose System and a laboratory system TRUE METRIX Self Monitoring Blood Glucose System blood tests should be performed within 30 minutes of a laboratory test If you have recently eaten fingerstick results from the TRUE METRIX Self Monitoring Blood Glucose System can be up to 70 mg dL higher than venous laboratory results 5 29 ...

Page 32: ...ediately Note Lo results are included in the Average as 20 mg dL Hi results are included as 600 mg dL If blood glucose test result is greater than 240 mg dL and Ketone Test Alert is turned on Ketone appears in Display with glucose result see Ketone Test Alert Caution When a Ketone Test Alert is shown in the meter Display it does not mean that ketones have been detected in your blood Perform a keto...

Page 33: ...d a series of beeps sound after about 10 seconds Release Button Meter goes into Set Up Set Time Date 2 The hour flashes To change press or Button on top of the meter to select the hour Like many alarm clocks to set AM or PM scroll through the hours until AM or PM appears in the Display Press Button to set 3 The minutes flash To change press or Button to select the minutes Press Button to set 31 ...

Page 34: ...month Press Button to set 5 The day number flashes To change press or Button to select the day Press Button to set 6 The year flashes To change press or Button to select the year Press Button to set Note Meter beeps every time a setting is confirmed Button is pressed 32 ...

Page 35: ...gs on or off Press Button to set then the Meter goes to set Ketone Test Alert Ketone Test Alert When a blood glucose result is over 240 mg dL the Ketone Test Alert is a reminder to check your ketones per your treatment plan 2 Press or Button to turn Alert on or off Press Button to set then the Meter goes to set Test Reminder Caution When a Ketone Test Alert is shown in the Dis play it does not mea...

Page 36: ...ows first Reminder setting A 1 To turn Reminder on press Button Press Button to turn Reminder back to off Press Button to set 2 When on is chosen press Button The hour flashes Press or Button to set the hour To set AM PM scroll press or Button until AM or PM is next to correct time Press Button to set 3 The minutes flash Press or Button to set the minutes Press Button to set Meter goes to the next Te...

Page 37: ...s and hold Button until meter turns off Meter also turns off after 2 minutes of non use Set 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 35 Test Reminder Symbol ...

Page 38: ... the Averages You can review the average of your glucose results from the last 7 14 or 30 days 1 With meter off press and release Button Display scrolls through 7 14 and 30 day Average values 2 Meter turns off after 2 minutes if no buttons are pressed Note If there are no Average values three dashes are displayed for 7 14 and 30 day Averages 36 No Average 30 Day Average 14 Day Average 7 Day Averag...

Page 39: ...recent blood test Press Button to scroll forward through results or Button to scroll backwards through results Test results marked as alternate site display ALT Symbol Control Test results display the Control Symbol If no Control Test has been done Display shows dashes and the Control Symbol Test results above 240 mg dL display Ketone Test Alert Symbol when Ketone Test Alert is turned on during Se...

Page 40: ...ng and Disinfecting Cleaning removes blood and soil from the meter Disinfecting removes most but not all possible infectious agents bacteria or virus from the meter including blood borne pathogens Clean and disinfect immediately after getting any blood on the meter or if meter is dirty Clean and disinfect meter at least once a week Meter may be cleaned and disinfected once a week for up to 5 years...

Page 41: ...ure on the front back left side right side top and bottom of the meter Discard used wipes Environmental Protection Agency 3 To Disinfect Using fresh wipes make sure that all outside surfaces of the meter remain wet for 2 minutes Make sure no liquids enter the Test Port or an other opening in the meter 4 Let meter air dry thoroughly before using to test Super Sani Cloths may be purchased at the fol...

Page 42: ...uttons 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 Note Other disinfectants have not been tested The effect of other disinfectants used interchangeably has not been tested with the meter Use of disinfectants other than Super Sani Cloth Wipes may damage meter Note Super Sani Cloth Wipes have been tested on the me...

Page 43: ...e a day for a 3 year period If the lancing device is being operated by a second person who provides testing assistance the lancing device should be disinfected prior to use by the second person Do not clean lancing device if there is a lancet inside Remove lancet from lancing device before cleaning Cleaning step 2 must occur before disinfecting steps 3 and 4 To clean and disinfect the lancing devi...

Page 44: ...utton hard to push End Cap does not go back on Arming Barrel does not click when gently pulled back Note Other disinfectants have not been tested The effect of other disinfec tants used interchangeably has not been tested with the meter Use of disinfectants other than Super Sani Cloth Wipes may damage meter Note Super Sani Cloth Wipes have been tested on the lancing device for a total of 1095 clea...

Page 45: ...e test strips in original vial only Do not transfer test strips to new vial or store test strips outside of vial Write date first opened on test strip vial label Discard unused test strips from vial if either 4 months after first opening or after date printed next to EXP on label has passed whichever comes first Use of test strips past expiration dates may give incorrect results Close vial immedia...

Page 46: ... Ketone Test Alert and Test Reminders see Meter Set Up If meter does not turn on check that battery was installed properly If not remove and reinsert battery Turn meter on by pressing Button Call 1 800 803 6025 if problem persists Warning Battery is not rechargeable If you have a cable or a cradle for downloading results to a computer DO NOT plug the usb cable end into an electrical outlet Trying ...

Page 47: ...ve test strip Re insert test strip fully into meter Test strip error Repeat with new test strip Dead or no battery Replace battery Battery in backwards Battery positive side must face up Meter Error Call 1 800 803 6025 Reason Action Sample drop too small Repeat test with new test strip and larger drop Sample applied after two minute shut off Repeat test with new test strip Apply sample within 2 mi...

Page 48: ...trips to area between 41 F 104 F wait 10 minutes for system to reach room temperature before testing Sample Not Detected or Using Wrong Test Strip Retest with new test strip and larger sample Used Test Strip Test Strip outside of vial too long Sample on top of Test Strip Repeat with new test strip Make sure Sample Tip of test strip touched top of sample drop If error persists call 1 800 803 6025 M...

Page 49: ...0 803 6025 If you have symptoms such as fatigue excess urination thirst or blurry vision follow your healthcare professional s advice for high blood glucose Test Strip Removed During Test Retest with new test strip Make sure result is displayed before removing test strip Communication Error Call 1 800 803 6025 available 24 hours a day 7 days a week Low or Dead Battery Low About 50 tests can be don...

Page 50: ...not solve the problem call 1 800 803 6025 Display Reason Action Broken Display Do not use meter for testing Call 1 800 803 6025 WARNING Out of Range High Results 600 mg dL Low Results 20 mg dL WARNING Retest with new test strip If result is still Hi High or Lo Low contact Doctor immediately ...

Page 51: ... 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 results Operating Range meter test strips Relative Humidity 10 90 Non condensing Temperature 41 104 F Hematocrit 20 70 Altitude Up to and including 10 200 feet Note Use within specified environmental conditions only Chemical Composition TRUE METRIX Test Strips Glucose dehydrogena...

Page 52: ...meter to display false results 4 The duration of any implied Warranty including any implied Warranty of merchantability or fitness for a particular purpose shall be limited to the lifetime in use with the original user in accordance with any state law to the contrary 5 Nipro Diagnostics Inc disclaims liability for incidental or consequential damages for breach of any expressed or implied Warranty i...

Page 53: ...5 htm 3 CDC Clinical Reminder Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Finger stick DevicesBGM html 4 FoodandDrugAdministration BloodGlucoseMeters Gettingthe MostOutofYourMeter Electronic Version Retrieved December 22 2009fromhttp www fda gov MedicalDevices Safety Alert sandNotices TipsandArticlesonDev...

Page 54: ...52 RE4NPD03 Rev 6 EN Notes ...