Owner`s Booklet - Nipro Diagnostics
Contents
1. Note Replacing battery may affect date and time settings Check date and time by going to Set Up and scrolling through the time date settings by pressing 31 Troubleshooting 1 After inserting Test Strip Meter does not turn on Reason Strip inserted upside down or backwards Strip not fully inserted Strip Error Dead or no battery Battery in backwards Meter Error Action Remove Strip Re insert correctly Remove Strip Re insert Strip fully into Meter Repeat with new Strip Replace battery Battery positive side must face up Call for assistance 2 After applying sample test does not start Meter does not beep or begin countdown Reason Sample drop too small Sample applied after two minute shut off Problem with Test Strip Problem with Meter Action Repeat test with new Strip and larger drop Repeat test with new Strip and apply drop after Meter beeps Repeat with new Strip Call for assistance Messages Display Cc Lit ae 2 ae Reason Temperature rror Temperature change too quick Temperature Too Cold Meter temperature less than 50 F Temperature Too Hot Meter temperature greater than 104 F Sample Not Detected or Using Wrong Test Strip Used Test Strip or Test Strip outside of vial too long 33 Action Wait 10 minutes for Meter and Test Strips to reach room temperature before testing Move Meter and Test Strips to2. TRYWEbalance 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 Welcome to the TRUEbalance Blood Glucose Monitoring System Congratulations on your purchase of the TRUEbalance Blood Glucose Monitoring System You now have a very simple and accurate way to test your blood glucose sugar level anytime anywhere TRUEbalance is a no coding system which means the Meter does not have to be coded to each lot of Test Strips Our Commitment to You Our goal is to provide you with quality healthcare products and dedicated customer service If you have questions about using TRUEbalance products visit our web site at www niprodiagnostics com Instructions for use of the System for more than one person may be found in the Quality Assurance Quality Control Manual The QA QC Manual is available on our website www niprodiagnostics com or call 1 800 803 6025 or 1 954 677 4599 CAUTION Please read complete Owner s Booklet and all product Instructions for Use Expected Results for people without diabetes Plasma Blood Glucose Result Before eating lt 100 mg dL Importance of Blood Glucose Monitoring The more you know about diabetes the better you will be able to take care of yourself A Doctor or Diabetes Healthcare Professional will determine your target range for your blood glucose results and how often t
3. Average H i m values 3 dashes are displayed mgt 4 Press and release to view results in Memory Press and hold toturn Average Meter off or Meter turns off after 2 minutes of inactivity itd Mem Avg No Averages 27 Viewing Results in Memory Memory stores 365 results which are displayed from most recent to oldest The oldest result is removed from Memory when Memory is full and a new result is added l Start with Meter off Press and release 8 Meter displays date and time followed by 14 and 30 Day Morning Averages Press again to view most recent result in Memory Memory Press gt and release to advance to the first blood glucose result in Memory Press E gt and release again to view the latest Control Test result The control test result shows the Control Symbol in Display Only one Control Test Gs result is stored in Memory Continue to press and release E gt C ntrol to advance through the blood Symbol glucose results Holding E gt scrolls through the results quickly Press and release the f to reverse through the results Press and hold to turn Meter off Meter also turns off automatically after 2 minutes of inactivity 28 Caring for TRUEbalance e Store System Meter Glucose Control Test Strips in Carrying Case to protect from liquids dust and dirt e Store System in a dry place at room temperature 36 86 F DO NOT REFRIGER
4. area between 50 104 F before testing Move Meter and Test Strips to area between 50 104 F before testing Retest with new or correct Strip and larger sample Repeat with new Strip If error persists call for assistance Messages continued Display m M n mM l LM Reason Meter Error Test Strip Error Very high blood glucose result higher than 600 mg dL Test Stri Remove During Test Meter Error Meter Error 34 Action Call for assistance Retest with new Strip If error persists call for assistance If you have symptoms such as fatigue excess urination thirst or blurry vision follow your healthcare professional s advice for high blood glucose Retest with new Strip If error persists call for assistance Call for assistance Call for assistance Messages continued Reason Communication Error Low Battery Dead Battery WARNING Out of range Hi Result gt 600 mg dL Out of range Lo Result lt 20 mg dL 35 Action Turn Meter off and on again If error persists call for assistance About 50 tests can be done before battery must be replaced Replace battery WARNING Retest with new Strip If result is still Hi or ILO contact Doctor immediately System Specifications Result Range 20 600 mg dL Sample Size Minimum 1 microliter 1 uL Sample Fresh capillary whole blood or
5. ATE OR FREEZE e Do not keep meter in an area where it may be crushed ie back pocket drawer bottom of bag etc Meter Care Cleaning Disinfection Cleaning removes blood and soil disinfecting removes infectious agents To Clean the Meter removing blood or soil We suggest cleaning your Meter when visibly dirty Never put Meter in liquids or allow any liquids to enter the Test Port Wipe Meter with a clean lint free cloth dampened with 70 Isopropyl alcohol Let Meter air dry thoroughly before using to test Do not use bleach to clean the Meter For assistance contact Customer Care using the phone number on the cover of the Owner s Booklet For Healthcare Professionals please refer to the Quality Assurance Quality Control Manual for instructions on Meter Care Cleaning Disinfection The QA QC Manual is available on our website www niprodiagnostics com or call 1 800 803 6025 or 1 954 677 4599 Glucose Control Care e Write date opened on Control label Discard 3 months after opening or after date printed next to EXP whichever comes first e After use wipe bottle tip clean and recap tightly e Store at room temperature 36 86 F DO NOT REFRIGERATE OR FREEZE Test Strip Care e Store Strips in original vial only Do not transfer old Strips to new vial e Write date opened on vial Discard unused Strips from vial 120 days after opening or after date printed next to EXP whichever comes first Us
6. Glucose Control Test Time 10 seconds Result Value Plasma values Assay Method Electrochemical Reference Method Yellow Springs Instrument YSI Power Supply One 3V lithium battery CR2032 non rechargable Battery Life Approximately 1 100 tests or 1 year Automatic shut off After two minutes of non use Weight 1 66 ounces Size 3 52 x 2 15 x 0 67 Memory Size 365 blood glucose results 1 Control Test result Operating Range Meter amp Test Strips Relative Humidity 10 90 Non condensing Temperature 50 F 104 F Hematocrit 30 55 Note Use within specified environmental conditions only 36 Chemical Composition TRUEbalance Test Strips Glucose Oxidase a Eta sp 2 5 Units Mediators Buffers and Stabilizers TRUEcontrol Glucose Control Contents Volume 3 mL Water 73 D glucose 0 09 0 20 Viscosity Enhancing Agent 25 Inorganic Salts 1 8 Amaranth 0 08 and Preservatives 0 03 37 TRUEbalance Limited Lifetime Warranty Nipro Diagnostics Inc provides the following Warranty to the original retail purchaser of the TRUEbalance Meter 1 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 instruc
7. aged buttons If any damage is seen do not use Meter Call for assistance Check Strip vials for damage Discard any vials that appear cracked or broken 1 Check dates on Strip vial being used Do not use if 120 days past written date or date printed next to EXP whichever comes first 2 Wash hands and forearm for alternate site testing Rinse well and dry thoroughly 3 Remove Strip from vial Recap vial immediately Note Use Strip quickly after removal from vial Strips that have been left out of vial too long will give an error message when used Discard old Strip and use new Strip for testing 4 With Meter off insert Test Strip Contact End Contacts facing up into Test Port Meter turns on Keep Strip Contacts TRUEbalance in Meter until testing is Face A finished Up CH 22 5 Wait until Drop Symbol appears in Display Lance fingertip or forearm Allow drop to form With Test Strip still in Meter touch edge of Sample Tip to blood drop and allow blood to be drawn into Strip Remove Test Strip Sample Tip from sample drop immediately after the Meter beeps and starts to countdown on Meter Display Caution Holding the Test Strip Sample Tip to the blood sample too long after the Meter begins testing may cause inaccurate results Note If Meter did not beep and begin countdown soon after touching blood drop to Sample Tip discard Strip Repeat test with new Strip and new blood drop If problem pers
8. annot be changed by user 10 Time is P M Note AM does not appear PM is not an option if factory set for 24 hour clock Test Strip Front of Test Strip 2e Contact End Insert into Meter with Contacts metallic blocks facing up before adding sample Sample Tip Touch sample blood or Glucose Control to edge of Tip Placement of Sample to Test Strip gt j Correct Incorrect e Allow sample blood or Glucose Control drop to be drawn into Sample Tip Caution Holding the Test Strip Sample Tip to the blood sample too long after the Meter begins testing may cause inaccurate results e Do not smear or scrape drop with Strip e Do not apply more sample to Strip after removing from drop Note Do not apply blood or Glucose Control to top of Test Strip A Do not insert Sample Tip with sample into Meter for testing May damage Meter Contacts TRUEbalance Face Up 11 Test Strip Vial Label LOT EA645A4 EXP 2017 10 31 2 O 31 61 mg dL 1 87 117 mgd O 2 247 335 mg dL May 30 2014 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 120 days after written date or date printed next to EXP whichever comes first Control Range Range of numbers in which Control Test result must fall to assure System is working properly Caution U
9. ap and warm water after handling the Meter Lancing Device or Test Strips as contact with blood presents an infection risk IMPORTANT INFORMATION Health Related Information DO NOT perform capillary blood glucose testing on critically ill patients Capillary blood glucose levels in critically ill patients with reduced peripheral blood flow may not reflect the true physiological state Reduced peripheral blood flow may result from the following conditions for example e shock e severe hypotension e severe dehydration e hyperglycemia with hyperosmolarity with or without ketosis e Low blood glucose hypoglycemia symptoms may be trembling sweating intense hunger nervousness weakness and trouble speaking e High blood glucose hyperglycemia symptoms may be intense thirst a need to urinate often a dry mouth vomiting and headache If you have any of these symptoms check your blood glucose If your result does not match the way you feel repeat the test If your results still do not match the way you feel call your Doctor or Healthcare Professional 4 Important Information For the most accurate results using TRUEbalance Read all instructions before testing Meter displays results as plasma values TRUEbalance is an in vitro outside body quantitative system that is used for self testing and point of care bedside testing of human whole blood only Use only TRUEbalance Test Strips and TRUE
10. ation 2010 http www fda gov MedicalDevices Safety AlertsandNotices 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 Fingerstick DevicesBGM html 4 Atkins S H Dasmahapatra A Jaker M A Chorost M I Redd S Fingerstick Glucose Determination in Shock Annals of Internal Medicine 114 1020 1024 1991 5 Data on file 6 Larsson Cohn U Difference between capillary and venous blood glucose during oral glucose tolerance tests Scand J Clin Lab Invest 36 805 808 1976 7 U S Food 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 Safety AlertsandNotices TipsandArticlesonDeviceSafety ucm109371 htm 39 Notes H4NPD04 Rev 26 40
11. control Glucose Control with TRUEbalance Meter Do not use for diagnosis of diabetes or for testing blood glucose in newborns The TRUEbalance is recommended for testing of human capillary whole blood only TRUEbalance is not recommended for use with venous samples Perform Quality Control Testing before performing a blood test for the first time Note Three levels of TRUEcontrol Glucose Control Solution are available for Quality Control Testing We recommend testing at least 2 levels of Control Contact place of purchase or call for assistance to obtain Control Set date and time for correct Morning Average values When using the meter for the first time check the unit of measure in the meter Display after performing a control or blood test Result must display in the correct unit of measure mg dL If the result does not display in the correct unit of measure DO NOT use the meter and DO NOT use the meter result to determine treatment Health Related Information For Healthcare Professionals If comparing results between TRUEbalance and a lab system perform a TRUEbalance blood test within 30 minutes of lab test Results from TRUEbalance are considered accurate if within 20 of lab results If patient has recently eaten fingerstick results from TRUEbalance can be up to 70 mg dL higher than venous lab results Do not use venous blood with TRUEbalance Instructions for use of the System for more than one person may be foun
12. d in the Quality Assurance Quality Control Manual The QA QC Manual is available on our website www niprodiagnostics com or call 1 800 803 6025 or 1 954 677 4599 Table of Contents Fast Test Guide viss cevedescss asses aectscatsevcsesevses inside front cover Introductory Information ceceeeseeseseeseesseeseesesseesees 1 6 Table OF Contents sinen nena a A E deus tests 7 Know Your System Test Strip Test Strip Vial Label Control Bottle Label Getting Started Quality Control Tests fansnsanenania iunea 14 Automatic Self Testo Sieninis issiria 15 COMPO MN CSE enen a Raa 16 19 Testing your Blood How to Obtain a Blood Sample 0 0 How to Test Blood Glucose ceeeeeseees System Out of Range Warning Messages Set Up Time Date ssronanenssmsrcenrnnaraunrada Memory Morning Averages 14 and 30 Day cesceseeeessessesessesseeseess 27 Viewing Results in Memory sesssarmcsicinainieenieini 28 Care Cleaning Disinfection and Troubleshooting Caring for TRUEbalance Changing Battery THOUDIESNOOUING o 5 dscsevssscdsssassseseseveesuseiscndersosessesadbtesevsencasnsesas Display Messages scsissecccisssorvcsssssessisecnecsvonssstecnasonsorsssenss System Specifications Chemical Composition 0 0 cccsesessessseseeseesssseesseseesneeseeneesteases Meter Warranty osse coterie re E T saedevassoasiaees ReferenC S se ctactsanssteitsecesbainecstanugsatcivecacedetlansecigtuncesevers caubnuia saavitanes Know Your System M
13. e of Strips past either date may give incorrect results e Close vial immediately after removing Strip Use Strip quickly after removal from vial Never store Strips outside of vial Store in a dry place at room temperature below 86 F DO NOT REFRIGERATE OR FREEZE e Do not reuse Strip e Do not bend cut or alter Strips in any way 30 Changing Battery j Replace battery when Low or Dead J f Battery Symbol appears in Display or Meter does not turn on Low Dead 1 Lift tab on Battery Cover 2 Turn Meter over tap gently to loosen and remove battery 3 Insert new battery positive side up Close cover Note Use non rechargeable 3V lithium battery CR2032 4 Discard old battery in appropriate container 5 Turn Meter on If Meter will not turn on check that battery was installed properly If not reinsert battery and try again Call for assistance 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 to recharge the battery or power the meter by plugging into an electrical outlet will cause meter to catch on fire or melt Caution Battery is not rechargeable Battery might explode if mishandled or incorrectly replaced Do not dispose of battery in fire Do not disassemble or attempt to recharge battery Dispose according to local country specific regulations
14. eter Front of Meter Top of Meter Button Decrease numbers in Set Up remove Control Symbol move backward by time date when viewing results in Memory Button Select settings view Morning Average values view results in Memory E gt Button Increase numbers in Set Up add Control Symbol move forward by time date when viewing results in Memory Display Shows test results messages user prompts and other information Test Port Insert TRUEbalance Test Strip here Back of Meter Right Side of Meter Data Port For data download to a computer using the usb cable Contact Customer Care at the number located on cover for more information Caution Do not try to recharge battery by plugging usb cable into a power outlet Meter will be destroyed Battery Compartment Use one non rechargeable 3V lithium battery CR2032 positive side up Note See Changing Battery for details Meter Label Contains telephone number for assistance Serial Number Label Identifies Meter when calling for assistance NW OB WN re O oO Time Date 14 30 Day Average Result in Memory 14 or 30 Day Morning Average Test result Battery Symbol see Display Messages Temperature Symbol see Display Messages Drop Symbol Apply blood or Glucose Control Control Symbol see Control Test Unit of Measure Note Factory Set C
15. important to perform Control Tests with more than one level of Control to assure your System is working properly and your testing technique is good Contact place of purchase or call for assistance to obtain Control Caution Control ranges printed on Test Strip vial label are for Control Test results only and are not suggested levels for your blood glucose Do not drink Glucose Control Only the most current Control Test result is stored in Memory How to Test Glucose Control Use ONLY TRUEcontrol Glucose Control Solution with the TRUEbalance Meter 1 Note Use Strip quickly after removal from 35 ma 5 Wash hands with soap and water dry thoroughly Allow Control vial of Strips and Meter to adjust to room temperature 68 77 F Write date first opened on Control Label and or Strip vial label Check dates on Control label and Strip vial label Do not use Control if 3 months past written opened date or past date printed next to EXP whichever comes first Do not use Strips 120 days past written opened date or past date printed next to EXP whichever comes first Discard out of date products and use new products if either date has passed Swirl or invert bottle gently to mix Jo aons Control DO NOT SHAKE a Remove Strip from vial Recap vial immediately HEE 2 87 117 mg dL vial Strips that have been left out of vial too long will give an error message If error message appears in Display disca
16. ists see Troubleshooting 8 After countdown result is displayed with date and time Remove Strip and discard Result is stored in Memory Meter turns off Note When using the meter for the first time check the unit of measure in the meter Display after performing a control or blood test Result must display in the correct unit of measure mg dL If the result does not display in the correct unit of measure DO NOT use the meter and DO NOT use the meter result to determine treatment 9 Record result in log book Note Used Strips and lancets are considered biohazardous Dispose of used Strips and lancets in approved biohazard container System Out of Range Warning Messages CAUTION TRUEbalance measures blood glucose results from 20 600 mg dL If blood glucose result is less than T 20 mg dL Lo appears in Meter L Display If blood glucose result is greater Li than 600 mg dL Hi appears in I l Meter Display Always repeat test to confirm Low Lo and High Hi results If results still display Lo or Hi call your Doctor or Diabetes Healthcare Professional immediately Note Lo results are included in the Morning Average as 20 mg dL Hi results are included as 600 mg dL 24 Set Up Time Date 1 Start with Meter off Do not insert Test Strip Press and hold O Date Time W CLS appears in display Release after full Display appears and Meter beep
17. o test Having the majority of your results within your target range helps slow or stop complications of diabetes Having most blood glucose results within your target range shows how well a treatment plan is working to control glucose levels NEVER change your treatment plan without consulting with your Doctor or Diabetes Healthcare Professional Use of the TRUEbalance in a manner not specified in this Owner s Booklet is not recommended and may affect your ability to determine your blood glucose FOR PATIENTS IMPORTANT HEALTH and SAFETY INFORMATION WARNING NEVER reuse Test Strips NEVER wipe Test Strips with water alcohol or any cleaner DO NOT attempt to remove sample from Test Strips or clean Test Strips and re use Reuse of Test Strips will cause inaccurate results DO NOT add a second drop of sample to the Strip Adding more sample gives an error message The TRUEbalance Blood Glucose Monitoring System is for one person use ONLY DO NOT share your Meter or your Lancing Device with anyone including family members ALL parts of your Blood Glucose Monitoring System could carry blood borne diseases after use even after cleaning and disinfection For cleaning and disinfecting your Meter see Meter Care Cleaning Disinfection For cleaning and disinfecting your Lancing Device see the Instructions for Use Caution We suggest cleaning and disinfecting the Meter when visibly dirty Wash your hands thoroughly with so
18. p remove and discard used Lancet in appropriate container when testing is complete Note Used Strips and lancets are considered biohazardous Dispose used Strips and lancets in approved biohazard container 20 For Forearm Testing 1 Select area to be lanced Wash with soap and warm water rinse and dry thoroughly 2 Rub area vigorously or apply a warm compress to increase Blood flow CS of 3 Place end of Lancing Device firmly against forearm Press trigger button amp Apply firm pressure on lancing a device for 10 seconds i a Note Some lancing devices include a special end cap for alternate site testing Check lancing device Instructions for Use Important Notes Regarding Forearm Testing e Check with your Doctor or Diabetes 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 21 How to Test Blood Glucose Always check your supplies before using Check Meter for damage damaged or cracked Display missing or dam
19. rd old Strip and test with new Strip Insert Test Strip Contact End nN Contacts facing up into Test Port Meter turns on Keep Strip in Meter Face Up TRUEbalance until testing is finished Contacts 17 6 Press gt Control Symbol appears in Meter Display Note If you decide not to perform a Control Test press to remove Control Symbol Control 7 Turn Control bottle upside Symbol down Squeeze one drop of Control onto a clean tissue Wipe off bottle tip 8 Gently squeeze a drop on a small piece of unused aluminum foil or clear plastic wrap Dispose after use 9 With Strip still in Meter touch edge of Sample Tip to drop of Control and allow drop to be drawn into Strip Remove Strip from drop when Meter beeps Note If Meter does not beep and begin countdown soon after placing Sample Tip to Control drop discard Strip Repeat test with new Strip If problem persists see Troubleshooting yr 10 Compare result to Control range printed on Strip vial label If result is in range System can be used for testing blood If result does not fall within range repeat test using a new Strip TRWEcontrol Glucose Control Contral de Glucosa jonufactured for O 31 61 mg dL 1 87 117 mg dl 247 335 mg dL Note Control Test result shows the Control Symbol in the Display Note When using the meter for the first time check the unit of measure in the meter Di
20. s Set Time 2 The hour flashes To change press gt or on top of Meter to select the hour Like many alarm clocks to set PM scroll through hours until PM appears in Display Note PM does not display if Meter is factory set to 24 hour clock Press Oto set 3 The minutes flash To change press Bor Eto select the minutes Press to set 25 BB 58 55858 ppg miz Full Display 5 35 Hour Minutes Set Date 4 The month number flashes To change press B gt or to oe select the month Press to set 5 The day number flashes To change press gt or GJto select the day Press Se to set 6 The year flashes To change press B gt or to zo select the year Press to set Month Exit Set up To review settings press O Make changes as needed per instructions above Press and hold Ountil Display goes blank Options are saved Meter turns off 26 Memory Morning Averages 14 and 30 Day For Morning Average values only the earliest blood test result performed between 4 00 am 9 59 am according to Meter clock is used Meter clock must be set correctly see Set Up for accurate Morning Average values 1 Start with Meter off Press and release Display shows 14 day Morning Average value and then 30 day Morning Average value 2 Meter switches between 14 and 30 day Morning Average values for 2 minutes before turning off 3 If there are no Morning
21. se of Test Strips or Glucose Control past the Expiration Dates may give incorrect test results Discard out of date products and test with new products Glucose Control Glucose Control Bottle Label TRWEcontrol Glucose Control Control de Glucosa evel Ni Manufactured for NIP IAC LOT 8LOA18 EXP 2017 10 31 May 30 2014 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 opening or date printed next to EXP on bottle label has passed whichever comes first Control Level 0 1 or 2 Three levels of TRUEcontrol Control are available We recommend testing at least 2 levels of Control Contact place of purchase or call for assistance to obtain Control Getting Started The Meter turns on automatically when a Test Strip Contact End is inserted into the Test Port or when is pressed see Set Up and Memory The Meter turns off automatically after the Test Strip is removed from the Test Port or after 2 minutes of non use Meter comes with pre set time and date Before using the Meter for the first time or after a battery change check the time and date and update as needed see Set Up The TRUEbalance is a no coding system which means that the Meter does not have to be coded to each lot of Test Strips Quality Control Testing To assure you are getting accurate and reliable res
22. splay after performing a control or blood test Result must display in the correct unit of measure mg dL If the result does not display in the correct unit of measure DO NOT use the meter and DO NOT use the meter result to determine treatment 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 for assistance see cover for phone number 11 Remove Strip from Meter and discard Meter turns off Recap Control bottle tightly 19 How to Obtain a Blood Sample Refer to Lancing Device Instructions for Use for detailed instructions The Lancing Device is for single patient use ONLY For cleaning disinfecting your Lancing Device see Lancing Device Care in the Lancing Device Instructions for Use Wash your hands thoroughly with soap and warm water after handling the Meter Lancing Device or Test Strips Contact with blood presents an infection risk e Never share lancets or lancing device e Lancets are for single use only Do not re use From Fingertip 1 Prepare fingertip by washing hands in warm soapy water Rinse well Dry thoroughly I 2 Place end of Lancing Device ST against tip of finger Lance fingertip y XV 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 Test Strip Always reca
23. tions for use is not covered by this Warranty 2 This Warranty does not include the battery supplied with the Meter 3 Do not take the Meter apart This action will void the Warranty and cause the 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 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 6 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 38 References 1 American Diabetes Association Diagnosis and Classification of Diabetes Mellitus Diabetes Care Volume 36 Supplement 1 January 2013 2 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens Initial Communic
24. ults TRUEbalance offers two kinds of quality control tests These tests let you know that your TRUEbalance System is working properly and your testing technique is good ura Automatic Self Test An Automatic Self Test is performed by the Meter each time a TRUEbalance Test Strip is inserted correctly into the Test Port Insert a Strip into the Test Port The Meter is working properly if e the full Display appears then e the time appears in the upper part of the Display and then e 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 for assistance see cover for phone number Caution If any segments are missing in the Display when Meter is first turned on do not use the Meter for testing Call for assistance 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 Occasionally as you use the vial of Strips When opening a new vial of Strips If results seem unusually high or low If a vial has been left opened or exposed to extreme heat or cold or humidity e If Meter damage is suspected Meter was dropped crushed wet etc Note Three levels of TRUEtest Glucose Control Solution are available for Quality Control Testing It is
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