Nipro TrueResult Twist 2, User Manual

Page 1: ...ion needed to get the most from the TRUEresult twist 2 System To start testing quickly please see the Quick Reference Guide found inside the front cover of this Owner s Booklet Please read complete Ow...

Page 2: ...or stop complications of diabetes NEVER change a treatment plan without consulting with a Doctor or Healthcare Professional Use of the TRUEresult twist 2 Blood Glucose Monitoring System in a manner no...

Page 3: ...est Remove only one Test Strip at a time from vial when testing Recap vial immediately after re moving Test Strip NEVER reuse Test Strips NEVER wipe Test Strips with water alcohol or any cleaner DO NO...

Page 4: ...blood borne pathogens after use even after cleaning and disinfection 2 3 For cleaning the Meter see Care Cleaning For cleaning the lancing device see the lancing device s Instructions for Use We sugge...

Page 5: ...y result from the following conditions for example 4 shock severe hypotension severe dehydration hyperglycaemia with hyperosmolarity with or without ketosis Do not use the TRUEresult twist 2 for the d...

Page 6: ...Solution 12 Attach Remove TRUEresult twist 2 Meter to TRUEresult Test Strip Vial 13 Getting Started 14 Quality Control Testing 15 Automatic Self Test 15 Control Test 16 How to Test Control Solution 1...

Page 7: ...29 Meter Care 29 Control Solution Care 30 Test Strip Care 30 Changing Battery 31 Troubleshooting 32 Messages 33 Technical Information 35 Performance Characteristics 35 System Specifications 39 Operat...

Page 8: ...ults in Memory mark result as Alternate Site set up date time Battery Tray Holds battery one non rechargeable 3V lithium battery CR2032 Meter Label Contains serial number of Meter Identifies Meter whe...

Page 9: ...te Control Symbol C Alternate Site Symbol A Average Symbol 7 14 or 30 day Test Result Memory Result Battery Symbol Units of Measure Factory set cannot be changed by user Drop Symbol 9 Meter Full Displ...

Page 10: ...mple Placement Correct Incorrect Do not touch Sample Tip to drop of sample unless Contact End is inserted into Meter Do not apply blood or Control Solution to top of Test Strip Do not smear or scrape...

Page 11: ...hs after opening or date printed next to on vial label has passed whichever comes first Use of Test Strips or Control Solution past the Use By Dates may give incorrect test results Discard out of date...

Page 12: ...bottle if either 3 months after opening or date printed next to on bottle label has passed whichever comes first Control Solution Level 1 2 or 3 Testing at least 2 levels of Control Solution is recom...

Page 13: ...tom of Meter firmly on vial top Meter must be seated flat on top of vial cap 3 Holding the vial twist the Meter 1 4 turn clockwise The Test Port area on the Meter should cover the vial lip if attached...

Page 14: ...ial for damage cracked vial broken vial etc Discard damaged vial and all contents Test Strips and use a new vial of Test Strips for testing Write date first opened on Test Strip vial Check Use By Date...

Page 15: ...h hands and dry thoroughly 2 Remove one Test Strip from the Test Strip vial and insert Test Strip into the Meter 3 Meter turns on The full Display appears and is replaced by the blinking Drop Symbol T...

Page 16: ...on performance of the System is needed If results seem unusually high or low If Meter damage is suspected Meter was dropped crushed wet etc Performing Control Tests with more than one level of Control...

Page 17: ...Dry thoroughly 4 Gently swirl or invert Control Solution bottle to mix DO NOT SHAKE 5 Remove one Test Strip from vial Close Test Strip vial immediately Use Test Strip quickly after removal from vial...

Page 18: ...m foil or clear plastic wrap Discard foil or plastic wrap after use Note Do not put drop on top of the Test Strip 9 With Test Strip still in Meter touch Sample Tip to top of the drop of Control Soluti...

Page 19: ...second Control Test System should not be used for testing blood Call for assistance see cover for phone number 12 After result is shown discard Test Strip in appropriate container Meter turns off Reca...

Page 20: ...false high results wash hands before using the System to test blood especially after handling fruit or other foods containing sugar From Fingertip 1 Prepare fingertip by washing hands in warm soapy w...

Page 21: ...t Strip 4 Recap and remove lancet from lancing device Discard used lancet into appropriate container Important Notes Regarding Forearm Testing6 Check with your Doctor or Healthcare Professional to see...

Page 22: ...into Meter Meter turns on Keep Test Strip in Meter until testing is finished Alternate Site Testing To mark test as alternate site forearm result press Set Button Result is marked as alternate site in...

Page 23: ...od drop If problem persists see Troubleshooting 7 After the test is finished result is displayed Record result in log book 8 Discard Test Strip in the appropriate container Note Removing Test Strip be...

Page 24: ...lucose hyperglycaemia symptoms may be intense thirst a need to urinate often a dry mouth vomiting and headache Meter reads blood glucose levels from 1 1 33 3 mmol L 20 600 mg dL If blood test result i...

Page 25: ...ng When comparing results between TRUEresult twist 2 and a laboratory system perform a TRUEresult twist 2 blood test within 30 minutes of laboratory test Diabetes experts have suggested that glucose m...

Page 26: ...umber by pressing the Set Button until the desired number appears Note Pressing and releasing the Set Button only makes the numbers increase by one Once the number reaches its limit it resets to the l...

Page 27: ...s within a 7 14 or 30 day period 1 With Meter off press and release Set Button 2 Display scrolls through the 7 14 and 30 day Averages Meter turns off after 2 minutes if Set Button is not pressed Note...

Page 28: ...most recent result in Memory with the date and then the time in the lower left Continue to press and release Set Button to scroll through results Holding the Set Button scrolls through the results qui...

Page 29: ...temperature DO NOT REFRIGERATE OR FREEZE Meter Care Cleaning removes blood and soil To Clean the Meter Clean the Meter when visibly dirty or if blood is on the Meter Never put Meter in liquids or all...

Page 30: ...de of vial Write date opened on Test Strip vial Discard unused Test Strips from vial if either 4 months after opening or after date printed next to on vial label has passed whichever comes first Use o...

Page 31: ...battery into Battery Tray with side facing up Slide Battery Tray back into Meter 5 Turn Meter back over and press Set Button to turn Meter on Note If Meter does not turn on open Battery Tray and check...

Page 32: ...of inserting Test Strip Repeat with new Test Strip Call for assistance Reason Test Strip inserted upside down or backwards Test Strip not fully inserted Test Strip Error Dead or no battery Battery in...

Page 33: ...d Test Strips to area between 10 C 40 C wait 10 minutes for System to reach room temperature before testing Retest with new Test Strip and larger sample Repeat with new Test Strip Make sure sample is...

Page 34: ...mmol L 600 mg dL Low Results 1 1 mmol L 20 mg dL Action Remove micro USB cable Retest with new Test Strip Make sure result is displayed before removing Test Strip Call for assistance Result was not re...

Page 35: ...g dL 49 131 328 SD mmol L 0 06 0 14 0 76 SD mg dL 1 1 2 5 13 7 CV 2 3 1 9 4 2 System Accuracy Diabetes experts have suggested that glucose meters should agree within 0 83 mmol L 15 mg dL of the medica...

Page 36: ...for glucose concentrations 5 55 mmol L 100 mg dL Within 0 28 mmol L 5 mg dL Within 0 56 mmol L 10 mg dL Within 0 83 mmol L 15 mg dL 14 28 50 24 28 86 28 28 100 Forearm Samples HCP vs YSI for glucose c...

Page 37: ...glucose measured values performed by healthcare professionals fell within Zone A and 1 fell within Zone B of the Parkes Error Grid PEG For Consumers 100 of TRUEresult twist 2 fingertip values performe...

Page 38: ...at glucose levels 5 55 mmol L 100 mg dL Forearm Samples for glucose concentrations between 1 1 33 3 mmol L 20 600 mg dL Within 0 83 mmol L 15 mg dL or 15 99 100 99 Parkes Error Grid 100 of individual...

Page 39: ...ble Battery Life Approximately 1 500 tests or 2 years Automatic shut off After two minutes of non use Weight 17 grams Size 4 3 cm x 3 7 cm 2 3 cm Memory Size 500 glucose results Operating Range Meter...

Page 40: ...rference from the meter to other electronically driven equipment is not anticipated The electromagnetic environment should be evaluated prior to operation of the device Do not use the meter in a very...

Page 41: ...22 2012 from http www cdc gov injectionsafety Fingerstick DevicesBGM html 4 Atkin S H et al Fingerstick Glucose Determination in Shock Annals of Internal Medicine 114 1020 1024 1991 5 Data on file 6 U...

Page 42: ...42 Notes...

Page 43: ...43 Notes...

Page 44: ...44 Q4INP03FD Rev 1 Notes...