Nipro TRUEresult mini, Owner'S Booklet

Page 1: ...Owner s Booklet BLOOD GLUCOSE MONITORING SYSTEM EASY TO USE TINY SAMPLE SIZE FAST RESULTS NO CODING CODING NO CODING...

Page 2: ...intended as a substitute for complete instructions Please read entire Owner s Booklet and product Instructions for Use before testing Expected Results for people without diabetes 1 Plasma Blood Gluco...

Page 3: ...st and what your target ranges are for blood glucose results Having most results within your target ranges show how well a treatment plan is working to control glucose levels Keeping results within yo...

Page 4: ...is for one person use ONLY DO NOT share your Meter or your Lancing Device with anyone including family members DO NOT use on more than one person ALL parts of your Blood Glucose Monitoring System coul...

Page 5: ...e way you feel repeat the test If your results still do not match the way you feel call your Doctor or Healthcare Professional r PX CMPPE HMVDPTF ZQPHMZDBFNJB TZNQUPNT may be trembling sweating intens...

Page 6: ...ggested that glucose meters should agree within 0 83 mmol L of a laboratory method when the glucose concentration is less than 4 2 mmol L and within 20 of a laboratory method when the glucose concentr...

Page 7: ...ote Three levels of TRUEresult Control Solution are available for Quality Control Testing Call for availability using the number located on the cover of this Owner s Booklet for information on obtaini...

Page 8: ...Solution 16 18 Testing your Blood Obtaining a Blood Sample 19 20 How to Test Blood Glucose 21 22 System Out of Range Warning Messages 23 Time and Date Set up 24 25 Meter Memory Viewing Averages 26 Vie...

Page 9: ...e values to view results in Memory and to access Time Date Set Up W Button Decrease numbers in Meter Set Up remove ALT Symbol move backward by date time when viewing results in Memory Display Screen S...

Page 10: ...Tray Gently pull to slide open Battery Tray Use one non rechargeable 3V lithium battery CR2032 positive side up see Changing Battery Meter Label Contains Serial Number of Meter 8 Back of Meter 1 Clos...

Page 11: ...Result 4 Time Date 5 Time is AM PM 6 Units of Measure Note Factory set cannot be changed by user 7 Result is from 7 14 or 30 day Average 8 Control Symbol 9 Alternate Site ALT Symbol 10 Drop Symbol Ap...

Page 12: ...TBNQMF CMPPE PS POUSPM 4PMVUJPO ESPQ to be drawn into Sample Tip until testing begins dashes moving across Display Holding the Test Strip Sample Tip to the blood sample too long after the Meter begins...

Page 13: ...ips if either 4 months after opening or date printed next to on vial label has passed Use of Test Strips or Control Solution past the Use By Date may give incorrect test results Discard out of date pr...

Page 14: ...d bottle if either 3 months after opening or date printed next to on bottle label has passed POUSPM 4PMVUJPO FWFM PS Three levels of TRUEresult Control Solution are available We recommend testing at l...

Page 15: ...ssed see Memory and Time and Date Set Up Meter turns off when the Strip is released from the Meter or after two minutes of non use Meter comes with pre set time and date Before using the Meter for the...

Page 16: ...t Test Strip is inserted correctly into the Test Port Insert a Strip into the Test Port The Meter is working properly if the full Display appears then the time appears in the upper right of the Displa...

Page 17: ...DUFE FUFS XBT ESPQQFE gotten wet crushed etc Control Tests check that the System is working properly and your testing technique is good Use ONLY TRUEresult Control Solution to perform Control Tests Th...

Page 18: ...ips if Use By Date have passed Control Solution 3 months after opening or date next to on label Strips 4 months after opening or date next to on label Discard expired products and use new products 3 S...

Page 19: ...clean tissue Wipe off bottle tip Gently squeeze a Control Solution drop onto a small piece of unused aluminum foil or clear plastic wrap Dispose after use 9 With Strip still in Meter touch edge of Sam...

Page 20: ...is outside range test again If result is still outside range System should not be used for testing blood Call for assistance After result is shown hold Meter with Test Strip pointing down Press Strip...

Page 21: ...Dry thoroughly Place end of Lancing Device against tip of finger Lance fingertip 3 Set Lancing Device aside To help blood drop form lower hand to waist level gently massage finger from palm to fingert...

Page 22: ...Use Important Notes Regarding Forearm Testing8 r Check with your Doctor or Diabetes Healthcare Professional to see if forearm testing is right for you r 3FTVMUT GSPN GPSFBSN BSF OPU BMXBZT UIF TBNF B...

Page 23: ...rt Test Strip Contact End blocks facing up into Test Port Meter turns on Keep Strip in Meter until testing is finished Note If Strip has been out of the vial too long before use an error message appea...

Page 24: ...o Sample Tip discard Strip Repeat test with new Strip and new blood drop If problem persists see Troubleshooting Dashes appear across Display to show Meter is testing 9 After the test is finished resu...

Page 25: ...s in Meter Display If blood test result is greater than 33 3 mmol L HI appears in Meter Display ALWAYS repeat test to confirm Low Lo and High HI results If results still display Lo or HI call your Doc...

Page 26: ...ase O The Meter goes into Set Up 4FU 5JNF BUF The hour flashes To change press V or W to select the hour Like many alarm clocks to set AM or PM scroll through the hours until AM or PM appears in the D...

Page 27: ...the month Press O to set 5 The day number flashes To change press V or W to select the day Press O to set 6 The year flashes To change press V or W to select the year Press O to set YJU 4FU 6Q Press a...

Page 28: ...temperature range see How to Test Control Solution the Control Solution may read as a blood test and be included in the Averages To review Averages 1 Start with Meter off Press and release O Button Di...

Page 29: ...If there are no results in Memory dashes appear with Memory symbol 2 Press V and release to advance to the first blood test Press V to scroll forward through results or W to scroll backwards through...

Page 30: ...REEZE FUFS BSF MFBOJOH JTJOGFDUJPO Cleaning removes blood and soil disinfecting removes infectious agents r 8F TVHHFTU DMFBOJOH ZPVS FUFS XIFO WJTJCMZ dirty Never put Meter in liquids or allow any liq...

Page 31: ...USJQT JO PSJHJOBM WJBM POMZ P OPU USBOTGFS old Strips to new vial or store Strips outside of vial r 8SJUF EBUF STU PQFOFE PO 4USJQ WJBM JTDBSE unused Strips from vial if either 4 months after opening...

Page 32: ...appropriate container 4 Insert new battery positive facing up into Battery Tray Slide Battery Tray closed If Battery Tray does not close easily reposition the battery and try to slide Tray closed aga...

Page 33: ...Batteries might explode if mishandled or incorrectly replaced Do not dispose of battery in fire Do not take apart or attempt to recharge battery Dispose according to local country specific regulation...

Page 34: ...of inserting Strip Repeat with new Strip Call for assistance Reason Strip inserted upside down or backwards Strip not fully inserted Strip Error Dead or no battery Battery in backwards Meter Error Re...

Page 35: ...p Error Action Move Meter and Strips to area between 10 C 40 C wait 10 minutes for System to reach room temperature before testing Retest with new TRUEresult Test Strip and larger sample Repeat with n...

Page 36: ...ving Strip Result was not recorded in Memory Retest with new Strip If error persists call for assistance Call for assistance Low About 50 tests can be done before battery dies Dead Battery Symbol appe...

Page 37: ...mini was tested by users at diabetes clinics large urban hospitals and diabetes care centers The table below shows how often user TRUEresult mini fingertip values can achieve these goals The fingerti...

Page 38: ...goals when users glucose values are not fluctuating TRUEresult mini Forearm Sample NNPM user forearm vs finger TRUEresult mini Forearm Sample NNPM user forearm vs finger 0 3 mmol L 9 13 69 0 6 mmol L...

Page 39: ...inst the Yellow Springs Instrument YSI Model 2300 Studies were conducted at 3 clinical sites by Health care Professionals Fingertip Capillary Blood 40 EBUB OHFS WT 4 4 Slope 0 98 y intercept 0 03 mmol...

Page 40: ...he YSI results at glucose levels 4 2 mmol L and within 20 at glucose levels 4 2 mmol L Fingertip Capillary Blood NNPM HCP finger vs YSI Fingertip Capillary Blood NNPM HCP finger vs YSI 0 3 mmol L 25 3...

Page 41: ...evels 4 2 mmol L and within 20 at glucose levels 4 2 mmol L when users glucose values are not fluctuating Forearm Capillary Blood NNPM HCP forearm vs HCP finger Forearm Capillary Blood NNPM HCP forear...

Page 42: ...ry 8JUIJO PU 1SFDJTJPO O 8JUIJO 7JBM 1SFDJTJPO O POUSPM 4PMVUJPO 1SFDJTJPO O Mean mmol L 2 3 4 2 6 8 9 8 16 5 SD mmol L 0 10 0 13 0 15 0 41 0 66 CV 4 3 3 2 2 2 4 1 4 0 Mean mmol L 2 5 6 2 17 2 SD mmol...

Page 43: ...ry Life Approximately 2146 tests or 1 5 years Automatic shut off After two minutes of non use Weight 25 5 g w out battery 28 3 g with battery Size 8 4 cm x 3 cm x 15 2 cm Memory Size 500 blood glucose...

Page 44: ...26 series Interference from the meter to other electronically driven equipment is not anticipated The electromagnetic environment should be evaluated prior to operation of the device Do not use the me...

Page 45: ...22 2012 from http www cdc gov injectionsafety Fingerstick DevicesBGM html 4 International Organization for Standardization In vitro diagnostic test systems Requirements for blood glucose monitoring sy...

Page 46: ...44 Notes N4IAU03FD Rev 20...

Page 47: ...om the finger or forearm capillary or venous The System may not be used for neonates The System is intended for at home use self testing and for use by healthcare professionals in both physicians offi...

Page 48: ...s Inc N4IAU03FD Rev 20 For assistance please call 1 800 451 737 Nipro Australia Pty Ltd Suite 3 500 Paci c Highway St Leonards NSW 2065 support niproaustralia com au BLOOD GLUCOSE MONITORING SYSTEM NO...