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Summary of Contents for Truly TBG-460
- Page 1 Model: TBG-460GC Blood Glucose / Cholesterol 2 in 1 Monitoring System User's Manual 2015/07/14 Rev.01 www.trulyinstrument.com...
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Page 2: Table Of Contents
Table of Contents Chapter 1 TRULY TBG-460GC Monitoring System 1.1 Introduction................1.2 Precautions................1.3 Intended Use................1.4 Labelling and Informations............. 1.5 System Components............... Chapter 2 Setup the meter 2.1 Set the Year/Month/Day/Hour/Minute/ Measurement unit..Chapter 3 How to perform Test 3.1 Before Testing................ -
Page 3: Chapter 1 Truly Tbg-460Gc Monitoring System
Glucose / Cholesterol Monitoring System require only a small amount of blood, the result is precisely calculated and displayed. Please read the entire "User's Manual" carefully before using the TRULY Blood Glucose / Cholesterol Monitoring System. The "User's Manual" guides you through the operation procedures with illustrated directions and help you find the required informations. -
Page 4: Intended Use
- Keep the meter and test strips at room temperature (10-30 C). 1.3 Intended Use Truly TBG-460GC Blood Glucose and Cholesterol Monitoring System is intended to be used for quantitative measurement of blood glucose level and cholesterol level in fresh capillary whole blood drawn from the fingertips. -
Page 5: Labelling And Informations
1.4 Labelling and Informations Do not re-use Read instructions Caution, consult Keep dry accompanying documents Operation temperature Storage temperature limitation limitation EU Representative In-vitro diagnostic Catalogue number Lot number (Product number) Use by Manufactured by CE certification 0123 1.5 System Components Meter (Front Side) Test Strip Port: Insert test strip here. - Page 6 Meter (Back Side) Battery Cover : For holding a 3V lithium battery Tag : Display information about the meter. Glucose Test Strip (Blue Color) Electronic Contact Bar : Sample Inlet : Insert Electronic Contact Bar of the The inlet where the whole blood or control test strip into the Test Port of the solution is drawn in.
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Page 7: Chapter 2 Setup The Meter
Code Strip ( Front View ) Contact Bar : Insert this end into Code Number the Test Port of the meter. GLUC 0709 CHOL A412 Test Mode : GLUC - Glucose CHOL - Total Cholesterol Chapter 2 Setup the meter 2.1 Set the Year/ Month/ Day/ Hour/ Minute/ Measurement unit Press and hold the “memory”... -
Page 8: Chapter 3 How To Perform Test
Chapter 3 How to perform Test 3.1 Before Testing Coding the Meter TRULY TBG-460GC meter should be coded before testing with TRULY test Strips for the first time, or every time a new box of test strips is used. - Page 9 Directions : 1. Insert code strip into the test port of the meter. Wait for the code number and test mode to appear on the screen. 设定 2. Make sure the code number on the screen is the same as the code number on the code strip, and the test mode is also the same as marked on the test vial.
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Page 10: Connect Ios Device Via Bluetooth
3.2 Connect iOS device via Bluetooth 1. Installation Prior to first use, Download and install "TRULY" application to your iOS device. (Bluetooth 4.0 capabilities, e.g. iPhone 4S, iPhone 5, NewiPad and iPadMini) Open "TRULY"... -
Page 11: Perform The Blood Glucose Test
3. Press the “Glucose & Cholesterol” button. 3.3 Perform the Blood Glucose Test Directions : 1. Insert a Blood Glucose test strip (blue color) into the test strip port of the meter and immediately cover the vial to keep the strips in dry condition. The meter will turn on automatically. -
Page 12: Perform The Total Cholesterol Test
4. Touch the sample Inlet of the strip to the drop of blood sample until the meter sounds a “beep”, which means the sample has drawn into strip successfully. 5. The screen will display a count down from 10 seconds for glucose testing. 6. -
Page 13: Special Messages
Note : The TBG-460GC Monitoring System includes glucose and total cholesterol test that are all plasma calibrated. The user does not have to convert it into plasma result. 2. Use the strips before the expiry date, the strips can only be used within 3 months remaining shelf life after the first opening of the vial. -
Page 14: Chapter 4 Quality Control
Chapter 4 Quality Control Intended to use: The control solution is used to check the performance of the TRULY system, including Blood Glucose and Cholesterol Monitor System, Glucose and Cholesterol strip, user's test skill. The system is performing adequately if the control solution test result falls within the indicated control range listed on the test strips vial label. -
Page 15: Chapter 5 Meter Memory Function
Chapter 5 Meter Memory Function Truly TBG-460GC meter automatically stores up 360 blood glucose and 50 cholesterol test results. It also provides you with 7-, 14-, 21- and 28-day averages of the blood glucose test results. Please follow these directions to recall stored test results. -
Page 16: Chapter 6 Installing/Replacing The Batteries
5. After the 28day-average, the latest stored result M01 appears on the screen. Then you can read the stored result from M01 to M360(Glucose mode) or from M01 to M50(Cholesterol mode) by pressing Down or UP Button. 6. Press the “memory” button for over 3 seconds and the meter will turn off after a long “beep”... -
Page 17: Chapter 7 Storage And Handling Of Meter And Strips
Chapter 7 Storage and Handling of Meter and Strips Due to sensitive to heat and humidity, the performance of test strips may be affected by improper storage and handling. Please store the test strips and meter carefully according to the specifications listed in chapter 8. - Page 18 Message Cause Solution 1. There may be a problem Power off then retry, if the error with self-check of the appears again, contact the meter. authorized distributor for service. 2. Use of the wrong or Check that the code number on damaged code strip or the meter display matches the the code strip was...
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Page 19: Chapter 9 Specification
Chapter 9 Specification ± 20% at Glucose level ≥75 mg/dL (4.17mmol/L) System Accuracy ≥ ± 20% at Total Cholesterol 150mg/dL(3.88mmol/L) Principle Electrochemical Biosensor Calibration Plasma-equivalent Fresh Capillary whole blood Test Sample Measuring Time About 10 seconds (Glucose), 26 seconds (Total Cholesterol) Measuring Range Glucose 20 - 600 mg/dL (1.1 - 33.3 mmol/L) Total Cholesterol 100 - 400 mg/dL (2.59 - 10.35 mmol/L) -
Page 20: Fcc Statement
• Consult the dealer or an experienced technician for help. MODIFICATION: Any changes or modifications not expressly approved by the grantee of this device could void the user’s authority to operate the device. FCC ID: 2ABG7-TBG-460 -19-... - Page 21 Truly Instrument Ltd 2/F., Chung Shun Knitting Centre,1-3 Wing Yip St, Kwai Chung, N.T., HONG KONG Tel: (852) 2487 9803 Fax: (852) 2146 5756 Http: www.trulyinstrument.com EC - Representative Wellkang Ltd t/a Wellkang Tech Consulting Suite B, 29 Harley Street,...
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