Owner`s Booklet Manual de propietario
Contents
1. 29 System Out of Range Warning Messages ssseseceseceeees 30 Meter Set Up Set Timeand Dat eaaeaoue 31 Set Event Tags Ketone Test Alert and Test Remindets 33 Meter Memory View Averages 7 14 and 30 day ss ssssssssssssssssssssresessssrees 36 NTO WING SUG Gs aca tcorcyreqeestordarsn anei uione a te eee 37 Care Cleaning Disinfecting and Troubleshooting Carine Tor MAG cia ig Bd B Qe eeee neem ern nere errr mnrren tren 38 Changing Balety ossining oaar 4 gBcoy e Clo al ibs amereerernenre tere ureree teertcrre te onenian 45 Display CSS AO Geis csctccteceesec ray innesi EEE SEEN 46 System Specifications Chemical Composition 49 EE VV Ate tact A A cata oatao et oa A E 50 ROTETE a A T 51 TY OU E A E ect enact ce erences a2 Know Your System Meter Top of Meter O Sas lt Button Decrease numbers in Meter Set Up add ALT Symbol move backward by date time when viewing results and Averages in Memory scroll through Event Tags to mark results if feature on e 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 Front of Meter Back of Meter Display Screen Shows2. TRUE METRD SELF MONITORING BLOOD GLUCOSE SYSTEM Owner s Booklet Use only with TRUE METRIX Self Monitoring Blood Glucose Test Strips 24 7 Customer Consultation English or Spanish 1 800 803 6025 www niprodiagnostics com Manufactured by W NIPRO DIAGNOSTICS Fort Lauderdale FL 33309 U S A 2015 Nipro Diagnostics Inc TRUE METRIX and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics Inc RE4NPD03 Rev 6 TROE SELF MONITORING BLOOD GLUCOSE SYSTEM Fast Test Guide INSERT TEST STRIP 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 Expected Results for people without diabetes Plasma Blood Glucose Result Before eating lt 100 mg dL 2 hours after a meal lt 140 mg dL INTRODUCTION TRUE METRIX Self Monitoring Blood Glucose System TRUE METRIX is a simple accurate way to test your whole blood glucose sugar level anytime anywhere Our goal is to provide quality healthcare products and dedicated customer service For questions about TRUE METRIX products visit our web site at www niprodiagnostics com The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose sugar in fresh capillary whole blood samples drawn from the fingertip or forearm The TRUE METRIX Self Monitoring Blood Glucose System is inten
3. or lt Button to select the minutes Press e Button to set 31 4 The month number flashes To change press or lt Button to select the month Press e Button to set The day number flashes To change press gt or lt Button to select the day Press e Button to set The year flashes To change press or lt Button to select the year Press e Button to set Note Meter beeps every time a setting is confirmed Button is pressed 32 Set Event Tags Ketone Alert and Test Reminders Meter comes with Event Tags Ketone Test Alert and all Test Reminders off Note If the meter turns off at any time during Set Up go back to Step 1 under Meter Set Up and begin again Event Tags Event Tags are used to mark a test result that was taken during a specific event After setting the year press gt or lt Button to turn Event Tags on or off Press e Button to set then the Meter goes to set Ketone Test Alert Ketone Test Alert When a blood glucose result is over AEE 240 mg dL the Ketone Test Alert is a reminder to check your ketones per your rm treatment plan 2 Press or lt 4 Button to turn Alert oR on or off Press e Button to set then the Meter goes to set Test Reminder NNNnnn Cauti
4. Turn meter over e gently on the Tab palm of your other hand to loosen i and remove battery Battery Door 3 Discard old battery into appropriate container 4 Insert new battery positive side facing up Close Battery Door Note Use non rechargeable 3V lithium battery CR2032 5 Press e Button to turn meter on Check time date 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 es downloading results to a computer DO NOT plug the usb cable end into an electrical outlet Trying to recharge the battery or power the meter by plugging into an electrical outlet will cause meter to catch on fire or melt Caution 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 regulations LLL i hs bbb ibbeldccccecdccccccda 44 Troubleshooting 1 After inserting test strip meter does not turn on Test strip inserted upside Remove test strip down or backwards Re insert correctly Test strip not fully Remove test strip Re insert inserted test strip fully into meter Test strip error Repeat with new test strip Dead or
5. 2015 EXP 2017 10 31 LOT Lot Number LOT Used for identification when calling for assistance Expiration Dates EXP Write date first opened on bottle label Discard bottle if either 3 months after first opening or date printed next to EXP on bottle label has passed whichever comes first 3 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 Getting Started Meter comes with pre set time and date The Event Tag feature Ketone Test Alert and all Test Reminders are off Before using the meter for the first time or after a battery change check the time date Event Tags Alert and Reminders and update as needed see Meter Set Up The meter turns on when a test strip is inserted into the Test Port or when e Button is pressed see Memory and Meter Set Up Meter turns off when the test strip is released or removed from the meter e 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 clock to sound a tone for 10 seconds to remind you to test Up to four Test Reminders per day may be set Getting Started cont Event Tags allow you to tag your blood glucose results to link to the fol
6. device for a total of 1095 cleaning and disinfecting cycles which is equal to cleaning and disinfecting the lancing device once per day for a 3 year period Lancing device may be cleaned and disinfected up to 7 cycles per week for 3 years 42 TRUE METRIX Control Solution Care e Write date opened on control solution bottle label Discard if either 3 months after first opening or after date printed next to EXP on label has passed which ever comes first e After each use wipe bottle tip clean and recap tightly e Store at temperatures between 36 F 86 F DO NOT FREEZE TRUE METRIX Self Monitoring Test Strip Care e Store test strips in original vial only Do not transfer test strips to new vial or store test strips outside of vial e 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 e Close vial immediately after removing test strip Store in a dry place at temperatures between 40 F 86 F DO NOT FREEZE e Do not reuse test strip Do not bend cut or alter test strips in any way 43 Changing Battery A low battery displays Battery yee while continuing to function A dead battery ee displays Battery Symbol beeps and then i turns off To replace battery eal 1 Lift tab on Battery Door 2
7. results messages user prompts information Test Port Insert TRUE METRIX Test Strip here contact blocks 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 SNA Awd pi pk pi ek et AO m wne o Full Display Screen Dr Mood ARMO l PIZO YAIO Result is from Memory Time Date Time is AM PM Event Tag Symbols Result is from 7 14 or 30 day Average 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 Unit of Measure Note Factory set to mg dL cannot be changed by user 9 Test Strip Top of Test Strip Oz Contact End Insert into Test Port with contact blocks facing up Sample Tip Bring Tip of test strip to top of sam ple drop blood or control solution after Drop Symbol appears in the Display Note Insert test strip into meter before touching Sample Tip to blood or control solution drop Sample Placement wy Correct Incorrect e Allow sample drop to be drawn into Sample Tip until test ing begins meter beeps and dashes move across Display e Do not sm
8. NT INFORMATION cont 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 control solution The TRUE METRIX Self Monitoring Blood Glucose System is for one person use ONLY DO NOT share your meter or lancing device with anyone including family members Do not use on multiple patients ALL parts of your blood glucose monitoring system could carry blood borne pathogens after use even after cleaning and disinfecting 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 assistance the meter and lancing device should be disinfected prior to use by the second person It is important to keep the meter and the lancing device clean and disinfected For instructions on how to clean and disinfect the meter and lancing device see Meter Cleaning and Disinfecting and Lancing Device Cleaning and Disinfecting 4 IMPORTANT INFORMATION cont If you have symptoms of low or high blood glucose check your blood glucose immediately If your result does not match the way you feel repeat t
9. UULUUULLUUL DOLLA DLL LLL LLL ALLL LULL LULL DLL DLL LULL LLL dd hdd dh ddd ddl ddihilddhdddddddddddtldi 24 How to Test Blood 1 Check dates on test strip vial being used Do not use if either 4 months after first opening or after date printed next to EXP on label whichever comes first 2 Wash hands and forearm for alternative site testing Rinse well and dry thoroughly 3 Remove one test strip from vial Close vial immediately Use test strips quickly after removal 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 gt Button ALT Symbol appears in Display Press 4 Button to CQ remove ALT Symbol Wait until ap N Drop Drop Symbol appears in Display Symbol SY 9 Note 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 testing 25 Lance fingertip or forearm Allow drop to form see Obtaining a Blood Sample With test strip still in meter touch Sample Tip of test strip to top of blood drop and allow blood to be drawn into test strip Remove test strip from blood drop immediately after the meter beeps and dashes S appear across the Display drop to test strip
10. before disinfecting steps 3 and 4 To clean and disinfect the lancing device 1 Wash hands thoroughly with soap and water iS 2 To Clean With ONLY PDI Super e Sani Cloth Wipes EPA reg no 9480 4 rub the entire outside of ees the lancing device using 3 circular ore wiping motions with moderate pressure Discard used wipes Environmental Protection Agency 41 3 To Disinfect Using fresh wipes make sure that all outside surfaces of the lancing device remain wet for 2 minutes Super Sani Cloths may be purchased at the following places e Amazon com e Officedepot com or visit your local store e Walmart com 4 Let lancing device air dry thoroughly before using to test Replace End Cap Gently pull back Arming Barrel and press the Trigger Button A click will be heard if the lancing device is functioning properly ee 5 Wash hands thoroughly again after a handling the lancing device Stop using the lancing device and call Customer Care for assistance at 1 800 803 6025 if e Markings on lancing device are coming off e Trigger Button hard to push e End Cap does not go back on e 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
11. card 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 Disi Conteal 8 Gently squeeze a drop of control Solution Drop on solution onto a small piece of Tissue unused aluminum foil or clear plastic wrap Dispose after use 9 With test strip still in meter touch Sample Tip of test strip to top of drop of control solution Allow drop to be drawn into test strip Remove test strip from drop when meter beeps 10 Dashes appear across the Display to gt show meter is testing LT Meter testing Note If meter does not beep and begin testing soon after drawing up sample release and discard test strip Repeat test with new test strip If problem persists see Troubleshooting TRUE METRIX Control Solution Soluci n de Con 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 Control Solution Bottle Label 2 70 mg d 2 150 200 mg dL 3 301 398 mg dL oe ie Test Strip not fall within range repeat test Vial Label using a new test strip 12 00AM Note Control Test result shows the tt Control Symbol in the Display aa ontrol Symbol Example only Does not represent actua
12. ded 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 control The TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use Alternative site testing should be done only during steady state times when glucose is not changing rapidly The TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose sugar in fresh capillary whole blood samples drawn from the fingertip or forearm The TRUE METRIX Self Monitoring Meter measures the current detects analyzes and corrects for hematocrit and temperature and calculates the glucose result The TRUE METRIX Control Solution is for use with the TRUE METRIX Self Monitoring Meter and TRUE METRIX Self Monitoring 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 glucose results within your target range shows
13. discard test strip Repeat test with new test strip and new blood drop If problem persists see Troubleshooting C 12 00AM Dashes appear across Display to show meter is testing T 26 T To mark the result with an Event Tag After the test is finished result is 12 00AM displayed The Strip Release Button mn flashes ic make sure that Event Tags are turned on Test Result see Set Event Tags Ketone Alert and Test 2 30nM Reminders The Event Tag icons flash ma Press gt or 4 Button to go to the ILIC correct Event Tag Press e Button to mg fa mark the test result with an event icon Event Tag stops flashing Before Meal Icon shown Event Tags are as follows E X BH OR Before meal test was taken just before a meal After meal test was taken 2 hours after the start of 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 about this test result in the log book Top of Meter Record result in log book 27 8 Hold meter with test strip pointing down Press test strip Release Bu
14. e meter lancing device lancets or test strips as contact with blood presents an infection risk e 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 e It is important to keep the meter and the lancing device clean and disinfected For instructions on how to clean and disinfect the meter and lancing device see Meter Cleaning and Disinfecting and Lancing Device Cleaning and Disinfecting 21 Obtaining a Blood Sample cont Refer to lancing device Instructions for Use for detailed instructions e Never share lancets or lancing device Lancets are for single use only Do not re use Do not use venous blood for testing e To help prevent false high results wash hands before using the system to test blood especially after fruit has been handled From Fingertip l Zi Prepare fingertip by washing hands in warm soapy water Rinse well Dry thoroughly Place end of lancing device equipped TON with a lancet against tip of finger gt Lance fingertip 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 Recap and remove used lancet from lancing device The used lancet may be biohazardous Please discard i
15. e not suggested levels for your blood glucose Do not drink control solution LL 16 How to Test Control Solution Use ONLY TRUE METRIX Control Solution with the TRUE METRIX Self Monitoring Meter and Test Strips l Check dates on control solution label and test strip vial label Do not use control solution or test strips if expiration dates have passed apr Control solution 3 months after first opening or date next to EXP on 3 30 38 mgl label test strips 4 months after first opening or date next to EXP on labels Discard expired products and use new products 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 Gently swirl or invert control solution bottle to mix DO NOT SHAKE Remove one test strip from vial Close test strip vial immediately Use test strip quickly after removal from vial 5 Insert test strip into Test Port Meter turns on Note 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 oa ta Release and discard old test strip ane Use new test strip for testing a aS 6 Wait until Drop Symbol appears in Display Keep test strip in meter until testing is finished Drop Symbol error message appears Release and dis
16. ear or scrape drop with test strip e 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 May damage meter Test Strip Vial Label D LOT ABCT234 EXP 2017 10 31 2 1 72 90 mg dL G 150 200 mg dL 3 301 398 mg dL 2 May 30 2015 Lot Number LOT Used for identification when calling for assistance Expiration Dates EXP Write date first opened on vial label Discard vial and unused test strips if either 4 months after first opening or date printed next to EXP on vial label has passed whichever comes first NSN QQQ4 WD DD wDDwoweohnaA ANANTH aa RB HNn _ N___AIO_OM_M _ W 5 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 Lx is sh bbsdtsbiccidddciccdccccddcddcdrddrccccccdcdcdccaccodcooooooedccoeoeodeoadcedcededcdea 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 Control Solution Control Control Solution Bottle Label ETRIX g Solution Soluci n de con 21 Nivel 1 m 00 lt O 00 pone ude dae FL 33309 USA e only Sore ai ter sl ratur non Fra D0 NOT FREEZE R5NPDO1 May 30
17. ely 1000 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 results Operating Range meter amp 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 dehydrogenase FAD Aspergillus species mediators buffers and stabilizers TRUE METRIX Control Solution Water d glucose buffers viscosity enhancing agent salts dye and preservatives 49 TRUE METRIX Self Monitoring Limited Lifetime Warranty Nipro Diagnostics Inc provides the following Warranty to the original purchaser of the TRUE METRIX Self Monitoring Blood Glucose Meter l 6 Nipro Diagnostics Inc warrants this meter to be free of defects in materials and workmanship at the time of purchase If the meter is ever inoperative Nipro Diagnostics Inc will replace the meter with an equivalent meter at its option at no cost to the purchaser Failure of the meter due to abuse or use not in accordance with the instructions for use is not covered by this Warranty This Warranty does not include the battery supplied with the meter Do not take the meter apart This action will void the Warranty and cause the meter to display false results The duration of any implied Warranty i
18. ess urination thirst or blurry vision follow your glucose result higher than healthcare professional s 600 mg dL advice for high blood glucose Test Strip Retest with new test N strip Make sure result During Test is displayed before Ga removing test strip Call 1 800 803 6025 available 24 hours a day 7 days a week Communication Error Low About 50 tests can be done before battery dies Dead Battery Symbol appears and beeps before meter turns off If error message still appears any other error message appears or troubleshooting does not solve the problem call 1 800 803 6025 47 Display Do not use meter for testing Display Call 1 800 803 6025 Broken WARNING Retest with new test strip If result is still Hi High or Lo Low contact Doctor immediately WARNING Out of Range High Results gt 600 mg dL Low Results lt 20 mg dL If error message still appears any other error message appears or troubleshooting does not solve the problem call 1 800 803 6025 48 System Specifications Result Range 20 600 mg dL Sample Size 0 5 microliter 0 5 uL Sample Fresh capillary whole blood from the finger and forearm or control solution Test Time Results in as little as 4 seconds Result Value Plasma values Assay Method Amperometric Power Supply One 3V lithium battery CR2032 non rechargeable Battery Life Approximat
19. he test If your results still do not match the way you feel call your Doctor or Healthcare Professional Low blood glucose hypoglycemia symptoms 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 e Do not use for diagnosis of or screening of diabetes or for neonatal use e Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar state with or without ketosis Phone Number Fast Test Guide Expected Results Cover Introduction and Important Information 0 0 0 eee l Know Your System INTE LEE T T E A T 7 TSE SOUND eee E E essences 10 Control Solution ssssssssessssssssssseesssssstesssssteeesssreeessssreeesssrreesssses 12 Getting Started Quality Control Solution ssssssssssssssssssssrsessssrrssssssreessssrreesssses 15 Automatic Self TOG ecscascescareaceissceascnectenasesvaoescrsctersseareeesatencpesre 15 Control Tesi sas cdecaecccreanetsees carcn carey aceseoca eesuestaeores nen eneeaetier 16 How to Test Control Solution vcscuatacnicsesveesttatedenatnnevenrteceloamens 17 Testing your Blood Obtaining a Blood Samplers 21 How to Test BloOd eissii 25 TRUE METRIX System and Laboratory Testing
20. how well your treatment plan is working to control glucose levels Keeping results within your target range helps slow or stop complications from diabetes NEVER change your treatment plan without consulting a Doctor or Healthcare Professional IMPORTANT INFORMATION For the most accurate results using TRUE METRIX Read all product instructions for use before testing Use of TRUE METRIX in a manner not specified in this Owner s Booklet is not recommended and may affect ability to determine true blood glucose levels TRUE METRIX is an in vitro outside body quantitative system that is used for self testing of human whole blood only Alternative site forearm testing should not be used to calibrate continuous glucose monitors CGMs Alternative 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 or control solution from test strips or clean test strips and re use Reuse of test strips will cause inaccurate results NEVER add a second drop of sample to test strip Adding more sample gives an error message Perform Control Tests before performing a blood glucose test for the first time IMPORTA
21. l the meter will not perform a test Drop Symbol See Troubleshooting or call 1 800 803 6025 Liu lo D al Sao Error Message KNN Caution If any segments are missing in the Display when meter is first turned on do not use the meter for testing Call 1 800 803 6025 VULILLLLLLOLLLLULLOOLLILULLUULLDULALOULLULLLUUU LOO LLL VULL VULLULLLULLLLLULLLULLULUL LLL LULL VLLL LLLLULLLLLULLLLULL ULL ULLLULLVLLLULLLLULLLULLLULLLLULLLULLULLLULVULLVULLLLULLULLLULLLLLLLLLULU hdd hdd ld hl dddhddidddddddiddd dddd 15 Control Test We recommend performing Control Tests for practice before using your meter for the first time to test your blood Control Tests should be performed e For practice to ensure your testing technique is good e Occasionally as you use a vial of test strips e When opening a new vial of test strips e If results seem unusually high or low If a vial has been left opened or exposed to extreme heat or cold or humidity e Whenever a check on performance of the system is needed e 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 control solution N Caution Ranges printed on test strip vial label are for Control Test results only and ar
22. l Control Test ranges NNS Caution If Control Test result is outside range test again If result is still outside range system should not be used for testing blood Call 1 800 803 6025 LUUUUUULUUUUUULULULULLUULLULLUUULLULUUULULLUULLUULULUUULLULLUULLULUULLULLUULUUIULULLULUUULLUULLULULULULLULLUULUULLULLULLULLULULVULLLUULLULLUULULLUULLULLULLULULLULLLUULLULVUULULLUULLULLLULLLULUULUUULLULUULLULLUULLUUIULULLULULULLLUULLULUULLUIVUULLUIULULLULLULUUUUVUL 12 After result is shown 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 Obtaining a Blood Sample WARNING e The TRUE METRIX Self Monitoring Blood Glucose System is for one person use ONLY DO NOT share your meter or lancing device with anyone including family members Do not use on multiple patients e ALL parts of your blood glucose monitoring system could carry blood borne pathogens after use even after cleaning and disinfecting e Cleaning and disinfecting the lancing device and the meter destroys most but not necessarily all blood borne pathogens e Wash your hands thoroughly with soap and warm water before and after handling th
23. lowing events 1O CEN we Before meal test was taken just before a meal After meal test was taken 2 hours after the start of a meal Exercise test was taken during or after exercise Medications medication taken may have af fected 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 about this test result in your log book Tagging results helps track the effect specific events may have on your blood glucose test results Event Tagging may assist you and your doctor or health care provider with managing diabetes Quality Control Testing To assure you are getting accurate and reliable results TRUE METRIX offers two kinds of quality Control Tests These tests let you know that your System is working properly and your testing technique is good Automatic Self Test An Automatic Self Test is performed by the meter each time a test strip is inserted correctly into the Test Port Insert a test strip into the Test Port The meter is working properly if the full Display appears then Full Display the time appears in the upper 12 00AM part of the Display and then the Drop Symbol begins to blink If an error message appears in the Display o
24. ncluding 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 Nipro Diagnostics Inc disclaims liability for incidental or consequential damages for breach of any expressed or implied Warranty including any implied Warranty of merchantability or fitness for a particular use with respect to the meter Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitations or exclusion may not apply This Warranty gives the user specific legal rights and the user may also have other rights which vary state to state Your Nipro Diagnostics Inc Customer Care Representative will be able to provide detailed information regarding procedures for returning your meter if necessary 50 References l American Diabetes Association Diagnosis and Classification of Diabetes Mellitus Diabetes Care Volume 37 Supplement 1 January 2014 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm 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 Fo
25. ng off or are missing e Buttons are hard to push on the meter or do not work e Unable to insert test strip into Test Port e 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 meter for a total of 260 cleaning and disinfecting cycles which is equal to cleaning and disinfecting the meter once a week for a 5 year period The use life of the meter is 5 years 40 Lancing Device Care Cleaning and Disinfecting Cleaning removes blood and soil from the lancing device Disinfecting removes most but not all possible infectious agents bacteria or virus from the lancing device including blood borne pathogens e Clean and disinfect immediately after getting any blood on the lancing device or if lancing device is dirty e Clean and disinfect the lancing device at least once a week Lancing device may be cleaned and disinfected once a day for a 3 year period e 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 e Do not clean lancing device if there is a lancet inside Remove lancet from lancing device before cleaning e Cleaning step 2 must occur
26. no battery Replace battery Battery in backwards Battery positive side must face up Call 1 800 803 6025 2 After applying sample test does not start meter does not beep or begin testing Reason Action Sample drop too small Repeat test with new test strip and larger drop Sample applied after two Repeat test with new minute shut off test strip Apply sample within 2 minutes of inserting test strip Problem with test strip Repeat with new test strip Problem with meter Call 1 800 803 6025 For assistance call 1 800 803 6025 45 Messages ae Repeat with new test strip using capillary whole blood from the finger or forearm If error persists call 1 800 803 6025 T Move meter and test emperature b Riot str ps to area etween 41 F 104 F wait Too Cold 10 minutes for system to reach room temperature Too Hot before testing Invalid Hematocrit Sample Not Detected or Using Wrong Test Strip Retest with new test strip and larger sample Used Test Strip Repeat with new test strip Test Strip outside Make sure Sample Tip of of vial too long test strip touched top of Sample on top of sample drop If error Test Strip persists call 1 800 803 6025 Call 1 800 803 6025 Display ey Retest with new test strip If Test Strip error persists call Error or very 1 800 803 6025 If you have high blood symptoms such as fatigue exc
27. od and Drug Administration Blood Glucose Meters Getting the Most Out of Your Meter Electronic Version Retrieved December 22 2009 from http www fda gov MedicalDevices Satety Alert sandNotices TipsandArticlesonDeviceSafety ucm109371 html Larsson Cohn U Difference between capillary and venous blood glucose during oral glucose tolerance tests Scand J Clin Lab Invest 36 805 808 1976 51 Notes RE4NPD03 Rev 6 EN 52
28. on When a Ketone Test Alert is shown in the Dis play it does not mean that ketones have been detected in your blood Perform a ketone test per your treatment plan as prescribed by your Doctor or Healthcare Professional VULILLLLLILULLLLLLDUULLLLUTUULLUULULDULIUULU DULL IUU LULU DLL DULL LLL dd dhl dh ddhilddhdddddddhddtildi 33 Test Reminder Up to four Test Reminders per day may be set Reminder sounds at set time for 10 seconds Meter comes with all Test Reminders off To set the Test Reminders l After pressing e Button to set Ketone Test Alert Display shows first Reminder setting A 1 To turn Reminder on press gt Button Press Button to turn Reminder back to off Press e Button to set When on is chosen press e Button The hour flashes Press gt or lt Button to set the hour To set AM PM scroll press or lt Button until AM or PM is next to correct time Press e Button to set The minutes flash Press gt or lt Button to set the minutes Press e Button to set Meter goes to the next Test Reminder 34 4 Turn Reminders on and repeat setting the time for next 3 Reminders if needed Exit Set Up Ae ee Press and hold e Button until meter turns off Meter also turns off after 2 minutes of non use Set Up choices are sa
29. re Professional immediately eal 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 l 240 mg dL and Ketone Test Alert is turned L VLJ on Ketone appears in Display with glucose result see Ketone Test Alert K tone Test KNN 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 ketone test per your treatment plan as prescribed by your Doctor or Healthcare Professional VULILLLLLILULLLLLLDULLLOLU DULL LUULUTUUL UU LDUUL DOULA ALLL ULLADULLA LLL DLL ULLAL hhh ddd ddd ddhldddhdddddddddddldi Note Ketone Test Alert can be turned on or off during Meter Set Up 30 Meter Set Up Note If the meter turns off at any time during Set Up go back to Step 1 under Meter Set Up and begin again With meter off press and hold e Button until the full Display is shown and a series of beeps sound after about 10 seconds Release o Button Meter goes into Set Up gt gt Set Time Date 2 The hour flashes To change press gt or lt 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 e Button to set The minutes flash To change press gt
30. s testing assistance the meter and lancing device should be disinfected prior to use by the second person Do not clean the meter during a test e Cleaning step 2 must occur before disinfecting steps 3 and 4 38 To Clean and Disinfect the Meter 1 Wash hands thoroughly with soap and water 2 To Clean Make sure meter is off and a test strip is not inserted With ONLY PDI Super Sani Cloth Wipes EPA reg no 9480 4 rub the entire outside of the meter using 3 circular wiping motions with moderate pressure 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 i the meter remain wet for 2 minutes Dp Make sure no liquids enter the Test Gs Port or an other opening in the meter Super Sani Cloths may be purchased at the following places e Amazon com e Officedepot com or visit your local Office Depot store e Walmart com 4 Let meter air dry thoroughly before using to test 39 5 Wash hands thoroughly again after handling meter 6 Verify that the System is working properly by performing an one Self Test see Getting Started Stop using the meter and call Customer e Care for assistance at 1 800 803 6025 if e Meter display appears cloudy or any display segments are missing e Markings on meter including back meter label are comi
31. t carefully according to your healthcare provider s instructions 22 From Forearm Important Notes Regarding Forearm Testing e Check with your Doctor or Healthcare Professional to see if forearm testing is right for you e Results from forearm are not always the same as results from fingertip e Use fingertip instead of forearm for more accurate results Within 2 hours of eating exercise or taking insulin If your blood sugar may be rising or falling rapidly 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 Place end of lancing device equipped with a lancet firmly against forearm Press Trigger Button Apply firm pressure on lancing device for 10 seconds Apply sample to test strip Sample Tip 23 4 Recap and remove lancet from lancing device The used lancet may be biohazardous Please discard it carefully according to your healthcare provider s instructions NNNnnn Caution The used lancet may be biohazardous Please discard it carefully according to your healthcare provider s instructions VULILLLLLILULLLLLLLUULLOLUUUULUULUTUULUUULDUUU OULU T
32. trol 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 Set Up Tests marked with an Event Tag shows the Event Tag icon in the Display 37 pera Symbol ay 28 in ge EZ Alternate Site Symbol Lr Alert Symbol Event Tag Before Meal Icon shown Care Cleaning Disinfecting and Troubleshooting e Store System meter control solution test strips in Carrying Case to protect from liquids dust and dirt e Store in a dry place at temperatures between 40 F 86 F DO NOT FREEZE e Do not share your meter with anyone including family members e Allow system to sit at room temperature for 10 minutes before testing Do not keep meter in an area where it may be crushed i e back pocket drawer bottom of bag etc Meter Care Cleaning 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 e Clean and disinfect immediately after getting any blood on the meter or if meter is dirty e Clean and disinfect meter at least once a week Meter may be cleaned and disinfected once a week for up to 5 years e If the meter is being operated by a second person who provide
33. tton to discard test strip in the appropriate container Meter turns off Result is stored in 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 N89 oad dD DDG HDD I I I IID Gv 99999909999 Caution The used lancet and test strip may be biohazardous Please discard them carefully according to your healthcare provider s instructions LLL 28 TRUE METRIX Self Monitoring Blood Glucose System and Laboratory Testing When comparing results between TRUE METRIX Self Monitoring 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 29 System Out of Range Warning Messages WARNING Meter reads blood glucose levels from RENTEN 20 600 mg dL If test result is less than 20 mg dL C Lo appears in Display S S ngal If test result is greater than 600 mg dL n Hi appears in Display 12 00AM ALWAYS repeat blood tests to confirm Low Ll Lo and High Hi results If blood results i f still display Lo or Hi call your Doctor or Healthca
34. ved 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 Meter Memory View Averages 7 14 and 30 day The Averages feature allows you to view the average of all your blood glucose results within a 7 14 or 30 day period Control Test results are not included in 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 e Button Display scrolls through 7 14 and 30 day Average values 2 Meter turns off after 2 minutes if no buttons are pressed dashes are displayed for 7 14 and 30 day Averages 36 No Average View Memory Meter Memory stores 500 results When Memory is full the oldest result is replaced with the newest result 1 Press and release e Button Meter displays 7 14 and 30 day Averages Press and release e Button again to view most recent Control Test result in Memory If there are no results in Memory dashes appear with the Memory Symbol 2 Press Button and release to advance to the most recent blood test Press Button to scroll forward through results or lt 4 Button to scroll backwards through results Test results marked as alternate site display ALT Symbol Con
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