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Table of Contents
Related Manuals for NIPRO Diagnostics TRUEyou
Summary of Contents for NIPRO Diagnostics TRUEyou
- Page 1 (UK: 0800 08 588 08 Distributed by: Nipro Diagnostics (UK) Ltd 25 Barnes Wallis Road Segensworth East Fareham, Hampshire PO15 5TT Nipro Europe nv Weihoek 3H 1930 Zaventem Belgium 0197 © 2013 Nipro Diagnostics, Inc. E4GBY03FD Rev. 20 OWNER’S LIFETIME WARRANTY BOOKLET...
- Page 2 The TRUEyou Blood Glucose Monitoring System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm (capillary) or from the vein (venous).The System may not be used for neonates. The System is...
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Page 3: Introduction And Important Information
Welcome to the TRUEyou Blood Glucose Monitoring System Our Commitment to You TRUEyou 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 TRUEyou products, please see cover for phone number. - Page 4 NEVER change a treatment plan without consulting with a Doctor or Healthcare Professional. Use of the TRUEyou Blood Glucose Monitoring System in a manner not specified in this Owner’s Booklet is not recommended and may affect your ability to determine true blood glucose levels.
- Page 5 TRUEyou System: • Read all product instructions for use before testing. • Use only TRUEyou Test Strips and TRUEyou Control Solution with TRUEyou Meter. • To help prevent false high results, wash hands before using the System to test blood, especially after handling fruit or other foods containing sugar.
- Page 6 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 the TRUEyou Blood Glucose Monitoring System could carry blood- borne pathogens after use, even after cleaning and disinfection.
- Page 7 ~ severe hypotension ~ severe dehydration ~ hyperglycaemia with hyperosmolarity, with or without ketosis. • Do not use TRUEyou for the diagnosis of diabetes or for testing blood glucose in neonates (newborns). • Do not use TRUEyou System during a xylose absorption test.
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Page 8: Table Of Contents
Obtaining a Blood Sample .........20 How to Test Blood Glucose .......22 Unusual Blood Glucose Test Results ....25 Ketone Test Alert ..........26 TRUEyou System and Laboratory Testing ..27 Memory..............28 View Averages (7-, 14-, and 30-day) ....28 View Results ............29 Tyou_OB_Guts_E4GBY03FDr20.indd 6... - Page 9 Meter Set Up ............30 Set Ketone Test Alert ..........32 Set Testing Reminders ........32 Care, Cleaning/Disinfecting .......34 Meter Care ............34 Control Solution Care .........35 Test Strip Care .............35 Changing Battery ..........36 Troubleshooting ..........37 Messages..............38 Technical Information ........40 Performance Characteristics ......40 System Specifications ..........45 Operating Range ..........45 Chemical Composition ........45 EMC Safety Information ........46...
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Page 10: Know The System
KNOW THE SYSTEM Meter Top of Meter ➀ “ + ” Button Increase numbers in Time/Date Set Up for Meter and Testing Reminders; turn on Testing Reminders and Ketone Test Alert; add ALT Symbol; move forward by date/time when viewing results in Memory. - Page 11 Back of Meter ➀ Display Screen Shows test results, messages, user prompts, other information. ➁ Test Port Insert TRUEyou Test Strip here. ➂ Strip Release Button Releases Test Strip after testing. ➃ Battery Door Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up (see Changing...
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Page 12: Meter Display
Meter Display Full Display Screen 1. Memory Symbol 2. Time, Date 3. Result is from 7-, 14-, and 30-day Average 4. Day of Week 5. Test Result 6. Unit of Measure (Note: Factory set, cannot be changed by user.) 7. Ketone Test Alert Symbol 8. -
Page 13: Test Strip
Test Strip Top of Test Strip ➀ Contact End - Insert into Test Port with blocks (contacts) facing up. ➁ Sample Tip - Touch to top of sample (fresh, capillary or venous blood or Control Solution) after inserting Contact End into Meter. Sample Placement Correct Incorrect... - Page 14 Test Strip Vial Label May 30, 2014 ➀ Lot Number ( ) - Used for identification when calling for assistance. ➁ Use By Dates ( ) - 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 on vial label has passed, whichever...
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Page 15: Control Solution
Control Solution Control Solution Bottle Label ➀ Lot Number ( ) - Used for identification when calling for assistance. ➁ Use By Dates ( ) - Write date first opened on bottle label. Discard bottle if either 3 months after first opening or date printed next to bottle label has passed, whichever comes first. -
Page 16: Getting Started
GETTING STARTED The TRUEyou Meter comes with pre-set time, date, Ketone Test Alert and all Testing Reminders off. Before using Meter for the first time or after bat tery is changed, check to make sure all of the Meter pre-set functions are correct. -
Page 17: Quality Control Testing
Quality Control Testing To assure you are getting accurate and reliable results, TRUEyou offers two kinds of quality control tests. These tests let you know that your TRUEyou System is working properly and your testing technique is good. Automatic Self-Test An Automatic Self-Test ensures that the Meter is working correctly. -
Page 18: Control Test
Control Test The Control Test checks that the System is working correctly and testing technique is good. Use ONLY TRUEyou Control Solution to perform Control Tests. Perform Control Tests: • For practice before using the System for the first time, •... -
Page 19: How To Test Control Solution
How to Test Control Solution Use ONLY TRUEyou Control Solution with the TRUEyou Meter. 1. Check supplies. See Getting Started. 2. Allow Control Solution, vial of Test Strips and Meter to adjust to room temperature (20°C-25°C). Note: Running a Control Test at... - Page 20 7. With cap removed, turn Control Solution bottle upside down. Gently squeeze one drop of Control Solution onto a clean tissue. Wipe off bottle tip with the tissue. Note: If Test Strip is removed before testing Drop Symbol is finished, an error message appears. Release and discard old Test Strip.
- Page 21 11. Compare result to Control Test Range printed on Test Strip Control Solution vial label for Control Bottle Label Solution Level you are using. Test Strip If result is in range, Vial Label System can be used for testing blood. If result does not fall within range, repeat test using a new Test Strip.
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Page 22: Testing Blood
TESTING BLOOD Obtaining a Blood Sample Refer to lancing device’s 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’s Instructions for Use. Wash your hands thoroughly with soap and warm water after handling the Meter, lancing device, or Test Strips. - Page 23 From Forearm Note: Some lancing devices include a special end cap for alternate site testing. Check lancing device’s Instructions for Use. 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.
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Page 24: How To Test Blood Glucose
How to Test Blood Glucose 1. Check supplies. See Getting Started. 2. Wash hands (and forearm for alternate 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. - Page 25 5. Lance fingertip or forearm. Allow drop to form (see Obtaining a Blood Sample). 6. With Test Strip still in Meter, touch Sample Tip to top of blood drop and allow blood to be drawn into Test Strip. Remove from blood drop immediately after the Meter beeps and dashes appear across Meter Display.
- Page 26 8. Hold Meter with Test Strip pointing down. Press Strip Release Button to discard Test Strip in the appropriate container. 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.
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Page 27: Unusual Blood Glucose Test Results
Unusual Blood Glucose Test Results If you have symptoms of low or high glucose, check your blood glucose immediately. If your result does not match the way you feel, repeat test. If your results still do not match the way you feel, call your Doctor or Healthcare Professional. -
Page 28: Ketone Test Alert
Ketone Test Alert If blood glucose test result is greater than 13.3 mmol/L, and Ketone Test Alert is turned on, “Ketone” appears in Display with glucose result (see Set Ketone Test Alert). Ketone Test Alert When the Ketone Alert Symbol is shown, it does not mean that ketones have been detected in blood. -
Page 29: Trueyou System And Laboratory Testing
5.55 mmol/L, and within 15% of a laboratory method when the glucose concentration is 5.55 mmol/L or higher. If the patient has recently eaten, fingerstick results from the TRUEyou System can be up to 3.9 mmol/L higher than venous laboratory results. Tyou_OB_Guts_E4GBY03FDr20.indd 27 11/8/13 1:43 PM... -
Page 30: Memory
MEMORY View Averages (7-, 14-, and 30-Day) The Averages feature allows you to view the average of all blood glucose results within a 7-, 14-, and 30-day period. Results marked as Control Test results are not included in the Averages. Note: If a Control Test is performed outside the recommended testing... -
Page 31: View Results
View Results Memory stores 500 total blood and Control Test results, which are displayed from most recent to oldest. 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. -
Page 32: Meter Set Up
METER SET UP Meter Set Up is to be used if changes need to be made to the pre-set time and date, to turn on the Ketone Test Alert and Testing Reminders, or if settings need to be reset because of battery change. Note: Meter turns off after 2 minutes of non-use. - Page 33 3. The minutes flash. Slowly press the “ + ” Button to scroll minutes up or the “ - ” Button to scroll minutes down. Release “ + ” or “ - ” Button when the correct minutes are displayed. Press “ S “ Button and release to save the minutes and go to the next step.
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Page 34: Set Ketone Test Alert
Set Ketone Test Alert 7. After setting year, press “ + ” or “ - ” Button to turn Alert on or off. Press “ S ” Button to set and go to the Testing Reminders. Set Testing Reminders Up to four Testing Reminders per day may be set. Reminder sounds at set time for 10 seconds. - Page 35 10. The minutes flash. Press “ + ” Button or “ - ” Button to set the minutes. Press “ S ” Button to set. 11. Turn Reminders on and repeat setting the time for next 3 Reminders (if needed). 12.
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Page 36: Care, Cleaning/Disinfecting
CARE, CLEANING/DISINFECTING Caring for TRUEyou • Store System (Meter, Control Solution, Test Strips) in Carrying Case to protect from liquids, dust and dirt. • Store in a dry place at 2°C-30°C (room temperature). 30°C • DO NOT REFRIGERATE 2°C OR FREEZE. -
Page 37: Control Solution Care
Control Solution Care • Write date opened on Control Solution label. Discard if either 3 months after first opening or after date printed next to on bottle label has passed, whichever comes first. 30°C • Store at 2°C-30°C (room temperature). DO NOT REFRIGERATE 2°C OR FREEZE. -
Page 38: Changing Battery
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 Battery the palm of your other hand Door to loosen and remove battery. -
Page 39: Troubleshooting
TROUBLESHOOTING 1) After inserting Test Strip, Meter does not turn on. Reason Action 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. -
Page 40: Messages
Messages Display Reason Action Temperature Move Meter and Test Error Strips to area between • 10°C-40°C; wait 10 Too Cold/ minutes for System to Too Hot reach room temperature before testing. Sample Not Retest with new Detected or Test Strip and Using Wrong larger sample. -
Page 41: Removing Test Strip
Messages (continued) Display Reason Action Test Strip Retest with new Test Removed Strip. Make sure result During Test is displayed before removing Test Strip. Result was not recorded Memory in Memory. Retest with Error a new Test Strip. If error persists, call for assistance. -
Page 42: Technical Information
Performance Characteristics Precision: Precision describes the variation between results. There are two types of precision results measured, repeatability (using blood) and intermediate precision (using control solution). Repeatability: N=100 Mean (mmol/L) 3.4 12.1 19.2 SD (mmol/L) 0.11 0.14 0.27 0.37 0.66 Intermediate Precision: N=100 Mean (mmol/L) 3.1 19.5... - Page 43 For Healthcare Professionals 99.3% of healthcare professional (HCP) TRUEyou fingertip values fell within 0.83 mmol/L of the YSI results at glucose levels < 5.55 mmol/L and within 15% at glucose levels > 5.55 mmol/L. Fingertip Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L Within + 0.28 mmol/L...
- Page 44 100% of healthcare professional (HCP) TRUEyou forearm values fell within 0.83 mmol/L of the YSI results at glucose levels < 5.55 mmol/L and within 15% at glucose levels > 5.55 mmol/L. Forearm Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L Within + 0.28 mmol/L...
- Page 45 For Consumers 99.0% of user TRUEyou fingertip values fell within 0.83 mmol/L of the YSI results at glucose levels < 5.55 mmol/L and within 15% at glucose levels > 5.55 mmol/L. Fingertip Samples (user vs. YSI) for glucose concentrations <5.55 mmol/L Within + 0.28 mmol/L...
- Page 46 100% of user TRUEyou forearm values fell within 0.83 mmol/L of the YSI results at glucose levels < 5.55 mmol/L and within 15% at glucose levels > 5.55 mmol/L. Forearm Samples (user vs. YSI) for glucose concentrations <5.55 mmol/L Within + 0.28 mmol/L Within + 0.56 mmol/L...
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Page 47: System Specifications
Altitude: 3094 metres Note: Use within specified environmental conditions only. Chemical Composition TRUEyou Test Strips: Glucose dehydrogenase-FAD (Aspergillus sp.), mediators, buffers and stabilisers. TRUEyou Control Solution: Water, d-glucose, buffers, viscosity enhancing agent, salts, dye and preservatives. Tyou_OB_Guts_E4GBY03FDr20.indd 45 11/8/13 1:43 PM... -
Page 48: Emc Safety Information
EMC Safety Information This meter meets the electromagnetic immunity requirements as per ISO 15197:2013 Annex A. It meets the electromagnetic emissions requirements as per EN 61326 series. Interference from the meter to other electronically driven equipment is not anticipated. The electromagnetic environment should be evaluated prior to operation of the device. -
Page 49: Warranty
Warranty to the original purchaser of the TRUEyou Blood Glucose Meter: 1) Nipro Diagnostics (UK) Limited at the time of purchase. If the meter is ever inoperative, Nipro Diagnostics (UK) Limited will replace the Meter with an equivalent Meter, at its option, at no cost to the purchaser. -
Page 50: References
REFERENCES 1. Joslin Diabetes Center. Goals for Blood Glucose Control [Electronic Version]. Retrieved February 16, 2012 from http://www.joslin.org/info/Goals-for-Blood-Glucose- Control.html. 2. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens: Initial Communication Update 11/29/2010 [Electronic Version].