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Owner`s Booklet Libreta del propietario
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1. call your Doctor or Diabetes Healthcare Professional immediately 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 Testing Alert is turned on Ketone appears in Display with glucose result see Ketone Testing Alert Note Ketone Testing Alert can be Ketone Alert turned on or off during Meter Set up 25 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 1 Press and hold S until the full Display is shown and a tone sounds around 30 seconds Release S Meter goes into Set Up Set Time Date 2 The hour flashes To change press EKT or on top of the Meter to aS 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 S to set Note AM or PM does not display if Meter is factory set to 24 hour clock 3 The minutes flash To change press c lt 9 Ig pOPM or to select the minutes ZAIN Press S to set 26 4 The month number flashes To change press or mec ROE to select the month Press S to set 5 The day number flashes To change press or to select the day Press
2. A T against tip of finger Lance fingertip gV 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 recap 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 21 From Forearm 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 A of 3 Place end of Lancing Device firmly A against forearm Press trigger button B Apply firm pressure on lancing device di for 10 seconds S 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
3. Administration Center for Biologics Evaluation and Research Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose Parenteral Galactose Oral Xylose Containing Products Electronic Version Retrieved June 30 2009 www fda gov BiologicsBloodVaccines SafetyAvailability ucm154213 htm 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 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 8 Food and Drug Administration Blood Glucose Meters Getting the Most Out ofYour Meter Electronic Version Retrieved December 22 2009 from http www fda gov MedicalDevices Safety AlertsandNotices TipsandArticlesonDeviceSafety ucm109371 html E4NPD04 Rev 26 40
4. S to set 6 The year flashes To change press or to select the year Press S to set Note Day of the week Mon Tue dap le Wed Thu Fri Sat Sun self adjusts when month day or year are changed Note Meter beeps every time a setting is confirmed S is pressed 27 Setting Alert Ketone Testing Alert Note If the Meter turns off at any time during Set Up go back to Step 1 under Meter Set Up and begin again When a blood glucose result is over 240 mg dL the Ketone Testing Alert is a reminder to check your ketones per your treatment plan 1 After setting year press or to turn Alert on or off Press S to set Caution When a Ketone Testing Alert is shown in the Display it does not mean that ketones have been detected in your blood Perform a ketone test per your health plan as prescribed by your Doctor or Healthcare Professional 28 Testing Reminder Up to four Testing Reminders per day may be set Reminder sounds at set time for 10 seconds To set the Testing Reminders 1 After pressing S to set Ketone Testing Alert Display shows first r c Reminder setting A 1 Press on or off to turn Reminder on or off 2 If on is chosen press S The hour flashes Press or to set the hour To set AM PM scroll press or until AM or PM is next
5. battery CR2032 non rechargeable Battery Life Approximately 2146 tests or 1 5 years 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 50 104 F Hematocrit 20 60 Note Use within specified environmental conditions only Chemical Composition TRUEtest Test Strips Glucose dehydrogenase PQQ Acinetobacter calcoaceticus mediators buffers and stabilizers TRUEtest Glucose Control Contents Water d glucose buffers viscosity enhancing agent salts dye and preservatives 39 TRUEresult Limited Lifetime Warranty Nipro Diagnostics Inc provides the following Warranty to the original purchaser of the TRUEresult Blood Glucose 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 instructions 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 inclu
6. drawn into Strip Remove Test Strip Sample Tip from sample drop immediately after the Meter soon after touching blood drop to 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 Remove Strip from drop After the test is finished result is displayed The Strip Release Button flashes Record result in log book 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 Hold Meter with Strip pointing down Press Strip Release Button to discard Strip in the appropriate container Meter turns off Result is stored in Memory with day date and time cancels the test An error message appears and result is not stored in Memory Retest with a new Strip and do not remove before result is displayed 24 System Out of Range Warning Messages WARNING Meter reads blood glucose levels from 20 600 mg dL If blood test result is less than 20 mg dL Lo appears in Meter Display If blood test result is greater than 600 E mg dL Hi appears in Meter Display rp ALWAYS repeat test to confirm Low Lo and High Hi results If results still display Lo or Hi
7. 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 22 How to Test Blood Glucose 1 Check dates on Test Strip vial being used Do not use if either 4 months after opening or after date printed next to EXP on label whichever comes first 2 Wash hands and forearm for alternate site testing Rinse well and dry thoroughly 3 Remove one Strip from vial Close vial immediately Note Use Strips quickly after removal from vial 4 With Meter off insert Test Strip E Contact End blocks facing up into Test Port Meter turns on Keep Strip in Meter until testing is finished H Note If Strip has been out of the vial too w long before testing an error message appears upon insertion of the Strip into the Meter Release and discard old Strip Use new Strip for testing Note To mark test as alternate site result press Button ALT Symbol appears in Display Press to remove ALT Symbol 5 Wait until Drop Symbol appears in Display 6 Lance fingertip or forearm Allow drop to form see Obtaining a Blood E Sample OI Drop Symbol 23 7 beeps and dashes appear across the Meter Display Note If Meter does not begin testing g EA a Note When using the meter for the first time check 10 Note Removing Strip before result displays With Test Strip still in Meter touch edge of Sample tip to blood drop and allow blood to be
8. meter in an area where it may be crushed i e 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 the 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 and disinfection The QA QC Manual is available on our website www niprodiagnostics com or call 1 800 803 6049 or 1 954 677 4599 33 TRUEtest Glucose Control Care e Write date opened on Control label Discard if either 3 months after opening or after date printed next to EXP on label has passed 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 TRUEtest Test Strip Care e Store Strips in original vial only Do not transfer old Strips to new vial or store Strips outside of vial Write date opened on Strip vial Discard unused Strips from vial if either 4 months after open
9. TRYEresult Owner s Booklet Use only with TRUEtest Blood Glucose Test Strips 24 7 Customer Consultation English or Spanish 1 800 803 6025 1 954 677 9201 www niprodiagnostics com Manufactured by DIAGNOSTICS Fort Lauderdale FL 33309 U S A 2015 Nipro Diagnostics Inc TRUEtest TRUEresult and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics Inc e E4NPD03 Rev 26 TRYEresult Fast Test Guide 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 INTRODUCTION TRUEresult Blood Glucose Monitoring System TRUEresult is a simple accurate way to test whole blood glucose sugar level anytime anywhere Our goal is to provide quality healthcare products and dedicated customer service For questions about TRUEresult products visit our web site at www niprodiagnostics com Caution Please read complete Owner s Booklet and all product Instructions for Use Additional instructions for use of the System in a professional multi patient setting are included in the Quality Assurance Quality Control Manual The QA QC Manual is available on our website www niprodiagnostics com or call 1 800 803 6049 or 1 954 677 4599 Importance of Blood Glucose Monitoring The more yo
10. ample Repeat with new Strip ake sure sample is touched to edge of Strip not top If error persists call for assistance 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 37 Display lt a r E Removed E Fy During Test Communication Error Low or Dead Battery WARNING H Out of Range High Results gt 600 mg dL Out of Range Low Results lt 20 mg dL Action Retest with new Strip Make sure result is displayed before removing Strip Call for assistance Call for assistance Low About 50 tests can be done before battery dies Dead Battery Symbol opa and beep sounds efore Meter turns off WARNING Retest with new Strip If result is still Hi High or Lo Low contact Doctor immediately If error message still appears any other error message appears or troubleshooting does not solve the problem call for assistance 38 System Specifications Result Range 20 600 mg dL Sample Size Minimum 0 5 microliter 0 5 uL Sample Fresh capillary whole blood venous blood drawn in EDTA or heparin tubes or Glucose Control Test Time Results in as little as 4 seconds Result Value Plasma values Assay Method Electrochemical Power Supply One 3V lithium
11. ding 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 References 1 American Diabetes Association Diagnosis and Classification of Diabetes Mellitus Diabetes Care Volume 36 Supplement 1 January 2013 2 EDA 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 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 U S Food and Drug
12. e Use only laboratory methods for monitoring blood glucose levels in patients receiving interfering drugs e If there are pre print order sets for patients receiving interfering drugs include a prescription to test blood glucose using only laboratory methods e Establish facility protocols to verify point of care bedside blood glucose results with laboratory results for patients who are unresponsive or unable to communicate Other Important Information for Healthcare Professionals The most accurate results come from using fresh capillary whole blood from the fingertip or forearm Venous whole blood drawn into EDTA purple top tube or heparin green top tube may be used Mix tube contents gently before using When comparing results between TRUEresult and a laboratory system perform a TRUEresult blood test within 30 minutes of laboratory test Results from the TRUEresult System are considered accurate if within 20 of laboratory results If the patient has recently eaten fingerstick results from the TRUEresult System can be up to 70 mg dL higher than venous laboratory results 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
13. e shock e severe hypotension e severe dehydration e hyperglycemia with hyperosmolarity with or without ketosis IMPORTANT INFORMATION For the most accurate results using TRUEresult Read all instructions before testing TRUEresult is an in vitro outside body quantitative system that is used for self testing and point of care testing of human whole blood only Meter displays results as plasma values Use only TRUEtest Test Strips and TRUEtest Glucose Control with TRUEresult Meter Do not use for diagnosis of diabetes or for testing blood glucose in newborns Perform Control Tests before performing a blood glucose test for the first time see Getting Started Note Three levels of TRUEtest Glucose Control Solution are available for Quality Control Testing It is 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 Remove only one Strip at a time from vial when testing Recap vial immediately after removing Strip 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 7 E A E AE
14. eep Strip in Meter until testing is finished Note If Strip is removed before testing is finished an error message ae appears Release and discard old Strip Use new Strip for testing 7 Turn Control bottle upside down Squeeze one drop of Control onto a clean tissue Wipe off bottle tip 8 Gently squeeze a Control 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 Sample Tip to drop of Control Allow drop to be drawn into Strip Remove Strip from drop when Ogres Meter beeps 10 Dashes appear across the Display to show Meter is testing Note If Meter does not beep and begin testing soon after drawing up sample release and discard Strip Repeat test with new a Strip If problem persists see Troubleshooting 11 Compare result to Control Range printed on Strip vial label for Control Level you TRWEtest Glucose Control Control de Glucd Level Nivel 2__ 3 m are using Glucose Control If result is in range System can be used Bottle Label for testing blood 3161 mg d If result does not fall within range repeat 87 117 mg dl 3 247 335 mg dL Test Strip Vial Label test using a new Strip 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 Display after performing a control o
15. ing or after date printed next to EXP on label has passed whichever comes first Use of Strips past either date may give incorrect results Close vial immediately after removing Strip 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 34 Changing Battery A low battery displays Battery Symbol while continuing to function A dead battery displays Battery Symbol beeps and then turns off To replace battery 1 Lift tab on Battery Door 2 Turn Meter over tap gently on the palm of your other hand to loosen and remove battery 3 Discard old battery into appropriate container 4 Insert new battery positive facing up Close Battery Door Note Use non rechargeable 3V lithium battery CR2032 Press S Button to turn Meter on and check time date and Testing Alerts and Reminders see Meter Set Up If Meter does not turn on check that battery was installed properly If not remove and reinsert battery and turn Meter on by pressing S 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 replaced Do not dispose of batte
16. ing your Meter see Meter Care Cleaning Disinfection For cleaning and disinfecting your Lancing Device see the Instructions for Use Caution We suggest cleaning the Meter when visibly dirty Wash your hands thoroughly with soap and warm water after handling the Meter Lancing Device or Test Strips as contact with blood presents an infection risk FOR PATIENTS IMPORTANT HEALTH and SAFETY INFORMATION e DO NOT use the TRUEresult System to test your blood glucose if you are undergoing peritoneal dialysis dialysis through the abdomen stomach area e DO NOT use the TRUEresult System to test your blood glucose if you are receiving medical treatment that contains sugars such as maltose or xylose Extraneal Icodial immunoglobulins such as Octagam or Orencia The treatments listed above may cause false high glucose results when testing with the TRUEresult System Before using the TRUEresult System check with your Doctor or Healthcare Professional if you think you may be receiving any of these treatments 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 the 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 hy
17. ntrol de Glucosa Level Manufactured for Fabricado para Ninz DI Fe le For nostic use onh oom temperature between Hi 0 NOT REFRIGERATE OR FREEZE ESNPD1O Rev 20 May 30 2014 LOT 8LOA18 EXP 2017 10 31 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 1 2 or 3 Three levels of TRUEtest Control are available We recommend testing at least 2 levels of Control Use the number on the front cover for information on how to obtain different levels of Control Getting Started The Meter turns on when a Test Strip is inserted into the Test Port or when S Button is pressed see Memory and Meter Set Up Meter turns off when the Strip is released from the Meter or after 2 minutes of non use Meter comes with pre set time date and all testing Alerts and Reminders off Before using the Meter for the first time or after a battery change check the time date Alerts and Reminders and update as needed see Meter Set Up Quality Control Testing To assure you are getting accurate and reliable results TRUEresult offers two kinds of quality control tests These tests let you know that your TRUEresult J cS System is working properly and your rer Up testing technique is good Aut
18. omatic Self Test An Automatic Self Test is performed by the Meter each time a TRUEtest 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 part of the Display and then Fall Displey 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 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 a
19. perglycemia symptoms may be intense thirst a need to urinate often a dry mouth vomiting and headache 3 FOR HEALTHCARE PROFESSIONALS IMPORTANT HEALTH and SAFETY INFORMATION DO NOT use the TRUEresult System for patients receiving the following treatments e Peritoneal dialysis using solutions containing icodextrin Extraneal Icodial that is metabolized to maltose e Injections or infusions of solutions containing galactose or maltose including some human immunoglobulin preparations Octagam WinRho SDF Liquid HepaGam B e Xylose absorption testing e Intravenous solutions containing maltose e Any drugs that contain or metabolize to maltose galactose or xylose Orencia Adept Bexxar Using the TRUEresult System when receiving the above treatments may cause false high glucose results False high results may lead to inappropriate therapy which may result in coma or death Additional instructions for use of the System in a professional multi patient setting are included in the Quality Assurance Quality Control Manual The QA QC Manual is available on our website www niprodiagnostics com or call 1 800 803 6049 or 1 954 677 4599 Safe Practices Recommendations for Healthcare Professionals e At patient admission presentation and periodically throughout the patient s stay at the facility assess the presence and use of therapies containing interfering drugs see previous pag
20. r 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 12 After result is shown Strip Release Button flashes Hold Meter with Test Strip pointing down Press Strip Release Button to release and discard Strip in appropriate container j Meter turns off F Note AE Strip before result Q displays cancels the test An error message appears and the result is not stored in Memory Retest with a new Strip and do not remove before result is displayed 20 Obtaining 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 thoroughl 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 IE 2 Place end of Lancing Device
21. ry in fire Do not take apart or attempt to recharge battery Dispose according to local country specific regulations 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 testing Reason Sample drop too small Sample applied after two minute shut off Problem with Strip Problem with Meter Action Repeat test with new Strip and larger drop Repeat test with new Strip Apply sample within 2 minutes of inserting Strip Repeat with new Strip Call for assistance For assistance see cover for phone number Messages Display Reason Temperature rror Lc l e L Too Cold I Too Hot Sample Not Detected or Using Wrong Test Strip Used Strip Strip outside of vial too long Sample on top of Strip Test Strip Error Ve high bloo glucose result higher than 600 mg dL Action Move Meter and Strips to area between 50 104 F wait 10 minutes for System to reach room temperature before testing Retest with new TRUEtest Test Strip and larger s
22. s and release S 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 31 7 Day 14 Day 30 Day No Average Viewing Results in Memory Memory stores 500 results When the Memory is full the oldest result is replaced with the newest result 1 Press and release S Button Meter displays 7 14 and 30 day Averages Press and release S 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 and release to advance to the first blood test Press to scroll forward through results or 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 Control Symbol Test results above 240 mg dL display Alert Symbol when Ketone Testing Alert is turned on during user Meter Set Up Ketone Testing Alert 32 Caring for TRUEresult e Store System Meter Glucose Control Test Strips in Carrying Case to protect from liquids dust and dirt e Store in a dry place at room temperature 36 86 F DO NOT REFRIGERATE OR FREEZE e Do not keep
23. see covers Introduction and Important Information 0 0 000000 1 7 Table of COMENS oauan 8 Know Your System Mett arua avs tah atest aah taaavassbasasaanedseiactewstsactasacusatbestas 9 10 Meter Display isses soci tesastinatcastslinsci iv recratictias inet a R 11 Test SHIP ais aa a EA ai 12 Test Stip Vial Label oaaae 13 Glucose Control Bottle Label ssesseessssessrrsrersessrrrrsrssssreseee 14 Getting Started Quality Control s 4i sis nisressssactsacesstneessasaatearnnsstancsienss 15 16 Control Testicscisssci cists ceistsinlanaensnlioneincueiien 17 20 Testing your Blood Obtaining a Blood Sample Testing Blood Gl COSeisina unanini System Out of Range Warning Messages 25 Meter Set Up Thame and Date o sivsc5 sitessss desevs Sstsasdts aezevass stestins disse Gatdanstseee 26 27 Alert and Remind ersiiss siissvsstssseitis cess tistiseinas cocetisbosseites axe 28 30 Meter Memory Viewing Averages 7 14 and 30 day cscscseseseeseeseeseeees 31 Wie wing Results visa c atesisssscvesassecdetets stssusessgdesns save sheascsstvensavetesnys 32 Care Cleaning Disinfection and Troubleshooting Caring for TRU Erestlt svu ccisssssesiessssstvessscossntessesdesessestss 33 34 Changing Battery s ssacississstiscsccssessssiadessactestcssesdasssecusesnessesaens Troup esh OOtin gssatssesssessvsiccntsnssntssesesssades coasensouseeslensastesvovassogseaees Display Messages System Specifications Chemical Composition 00 39 Meter Warrant
24. ssistance to obtain Control Caution Ranges printed on Strip vial label are for Control Test results only and are not suggested levels for your blood glucose Do not drink Glucose Control How to Test Glucose Control Use ONLY TRUEtest Glucose Control Solution with the TRUEresult Meter 1 Allow Control vial of Strips and Meter to adjust to 68 77 F room temperature Write date first opened on both Control bottle label and Strip vial label Note Running a Control Test at temperatures outside the range listed above may cause Control to read as a blood test 2 Check dates on Control label and Strip vial label Do not use Control or Strips if Expiration Dates have passed Control 3 L months after opening or date next to EXP ftor t on label whichever ee first Strips 4 eee months after opening or date next to EXP 3 v mit on labels whichever comes first Discard expired products and use new products 3 Swirl or invert bottle gently to mix Control DO NOT SHAKE 4 Remove one Strip from vial Close Strip vial immediately Note Use Strip quickly after removal from vial 5 Insert Strip into Test Port Meter turns on S Note If Strip has been out of the vial too long before testing an error message appears upon insertion in of the Strip into the Meter f Release and discard old Strip Cora Use new Strip for testing face up 18 6 Wait until Drop Symbol appears in Display K
25. st Port with blocks contacts facing up Sample Tip Bring sample fresh capillary or venous blood or Glucose Control to edge of Tip Note Insert Strip into Meter before touching Sample Tip to blood or Control drop Sample Placement TRUES Correct Placement Incorrect Placement e Allow sample blood or Glucose Control drop to be drawn into Sample Tip until testing begins Meter beeps and dashes move across Display e Do not smear or scrape drop with Strip e Do not apply more sample to the Strip after testing begins Note Do not apply blood or Glucose Control to top of Test Strip Do not insert Sample Tip with sample into Meter for testing May damage Meter Test Strip Vial Label LOT L003 EXP 2017 10 31 2 1 31 61 mg dL 2 87 117 mg dL 3 247 335 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 Strips if either 4 months after opening or date printed next to EXP on vial label has passed whichever comes first Caution Use 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 Control Range Range of numbers in which Control Test results must fall to assure the System is working properly Glucose Control Glucose Control Bottle Label RUE Glucose Control Co
26. tien aaiae 40 References aisne anarian a aa 40 Know Your System Meter Top of Meter Button Increase numbers in Meter Set Up add ALT Symbol move forward by date time when viewing results in Memory S Button Turn Meter on to view Average values to view results in Memory and to access Meter Set Up Button Decrease numbers in Meter Set Up remove ALT Symbol move backward by date time when viewing results in Memory Front of Meter Back of Meter Display Screen Shows results messages user prompts information Test Port Insert TRUEtest Test Strip here Strip Release Button Releases Strip after testing Battery Door Use one non rechargeable 3V lithium battery CR2032 positive side up see Changing Battery Meter Label Contains serial number of Meter and phone number to call for assistance Data Contacts Connects cradle to meter for data upload to a computer 10 Full Display Screen Result is from Memory Time Date Time is AM PM Result is from 7 14 or 30 day Average Day of Week Test Result Units of Measure Note Factory set cannot be changed by user Ketone Test Alert Testing Reminder Temperature Symbol Drop Symbol Apply blood or Glucose Control Alternate Site ALT Symbol Battery Symbol Control Symbol Test Strip Top of Test Strip Or TRUEtest EEN ig Contact End Insert into Te
27. to correct time Press S to set ert Note AM or PM will not display if the Meter is factory set to 24 hour time format If off is chosen and the S is pressed the Meter goes to the next Testing Reminder c 3 Press on or off to turn Reminder on or off 4 The minutes flash Press or _ to set the minutes Press S to set 29 5 Turn Reminders on and repeat setting the time for next 3 Reminders if needed 6 Press and hold S when finished to turn off Meter Meter turns off after 2 minutes of non use Note If Alert or Testing Reminders are set the Alert Symbol appears in all Displays A Alert Symbol Note If battery dies or is replaced Alert and Testing Reminders may have to be reset Exit Set Up Press and hold S until Meter turns off Set up choices are saved 30 Viewing 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 normally included in the Averages Note Ifa Control Test is performed outside the recommended testing temperature see How to Perform a Control Test the Control may read as a blood test and be included in the Averages You can review the average of your glucose results from the last 7 14 or 30 days 1 Start with Meter off Pres
28. u know about diabetes the better you will be able to care for yourself A Doctor or Diabetes Healthcare Professional will determine 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 how well a 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 Diabetes Healthcare Professional Use of TRUEresult in a manner not specified in this Owner s Booklet is not recommended and may affect ability to determine true blood glucose levels 1 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 blood or control sample from Test Strips or clean Test Strips and re use Reuse of Test Strips will cause inaccurate results e NEVER add a second drop of sample to Strip Adding more sample gives an error message The TRUEresult Blood Glucose Monitoring System 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 could carry blood borne diseases after use even after cleaning and disinfection For cleaning and disinfect
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