Model: TBG-460GC Blood Glucose / Cholesterol 2 in 1 Monitoring System User's Manual 2015/07/14 Rev.01 www.trulyinstrument.
Table of Contents Chapter 1 TRULY TBG-460GC Monitoring System 1.1 Introduction.............................................................................. 2 1.2 Precautions.............................................................................. 2 1.3 Intended Use............................................................................ 3 1.4 Labelling and Informations..................................................... 4 1.5 System Components.......................................................
Chapter 1 TRULY TBG-460GC Monitoring System 1.1 Introduction Thank you for choosing TRULY Blood Glucose / Cholesterol Monitoring System. Please read the "User's Manual" for your convenient and for safe use. The TRULY Blood Glucose / Cholesterol Monitoring System provides you with accurate, plasma-calibrated results based on electrochemical sense technology and the superior capillary sampling.
- Handle the strip with clean and dry hands; lancing site for the test should be cleaned and dried thoroughly. - Do not perform the test while a cell phone is used beside; prevent the electronic signal interference. - Oxygen concentration in air is low may cause the test inaccurate; there is no effect from altitude up to 10,000 feet above sea level.
1.4 Labelling and Informations Do not re-use Read instructions Keep dry Caution, consult accompanying documents Operation temperature limitation Storage temperature limitation In-vitro diagnostic EU Representative Lot number Catalogue number (Product number) Use by Manufactured by 0123 CE certification 1.5 System Components Meter (Front Side) Test Strip Port: Insert test strip here. The meter will turn on automatically. LCD Screen : For display of operating information and test results.
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 : Insert Electronic Contact Bar of the test strip into the Test Port of the meter to activate it. GLUC Sample Inlet : The inlet where the whole blood or control solution is drawn in.
Code Strip ( Front View ) Contact Bar : Insert this end into the Test Port of the meter. Code Number 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” button for over three seconds, the meter will sound one beep and enter the setting mode. Please follow the directions below to set the meter.
Set the Day 1. Press up/dowm button until the correct day appears. 2. Press the “memory” button, and the hour segment will start blinking. Set the Hour 1. Press up/ down button until the correct hour appears. 2. Press the “memory” button, and the minute segment will start blinking. Set the Minute 1. Press up/ down button until the correct minute appears. 2. Press the “memory” button then measurement unit segment starts blinking. 1. Press the up/dowm button until the correct measurement unit appears. 2.
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. Remove the code strip. “ ” should appear on the screen, indicating that the meter has been successfully coded.
4. 6. 5. 8 1. Remove the end cap by gently pushing it down and away from the lancing device. 2. Insert the lancet firmly into the lancet holder until it comes to a stop and remove the protective lancet cover. 3. Replace the end cap by snapping it back onto the lancing device body. 4. Select the skin penetration depth by turning the depth selector until the desired number can be seen in the selection window. 5 levels of skin penetration: The higher the number, the deeper it pricks. 5.
3. Press the “Glucose & Cholesterol” button. 3.3 Perform the Blood Glucose Test GLUC Directions : 设定 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. 2. Be careful to make sure the test mode and code number on the screen are the same as the one marked on the test strip vial.
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. When the measurement is complete, the glucose value will display on Blood Glucose monitor & save on iOS application screen. 3.4 Perform the Total Cholesterol Test 1.
Note : 1. 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. 3. Apply the blood sample onto the correct position of the strip precisely, follow the directions to avoid incorrect operations. 4.
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. A control test should be proceeded: 1. When you suspect that the meter or test strips are not working properly. 2.
. Please read this user's manual for control solution test carefully before use. . Do not reuse the Test Strips and close the Test Strip Vial lid tightly after use. . The first three drops of Control Solution must be discarded and the vial should be shaked well before use when the vial is newly opened. . Newly opened vial of Control Solution and Test Strips must be marked with the opening date. .
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” sound. Meter will also automatically shut down after 3 minutes without any operation.
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. Note: ● Store the meter, code strip, test strips at room temperature. Do not expose them beyond the range described in Chapter 8. ● Do not freeze or refrigerate the meter and strips.
Message Cause Solution E-E 1. There may be a problem with self-check of the meter. 2. Use of the wrong or damaged code strip or the code strip was inserted improperly. Power off then retry, if the error appears again, contact the authorized distributor for service. Check that the code number on the meter display matches the code number on the test strip vial. Code the meter or retest as necessary. If the error message appears again, please contact the dealer for service.
Chapter 9 Specification System Accuracy ± 20% at Glucose level ≥75 mg/dL (4.17mmol/L) ± 20% at Total Cholesterol ≥150mg/dL(3.88mmol/L) Principle Electrochemical Biosensor Calibration Plasma-equivalent Test Sample Fresh Capillary whole blood 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) Sample Volume About 1 - 1.
FCC Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) This device may not cause harmful interference, and 2) This device must accept any interference received, including interference that my cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
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