Tianjin Empecs Medical Device GH8123BT User Manual
Medisign® GH83 BT
Blood Glucose Monitoring System
User Manual
Read this first:
Please keep this instruction for future reference, as it contains important information.
Before using this product, read all instructions and practice the test. Do all quality control
checks as directed and consult with a diabetes healthcare professional.
Please confirm the measuring unit on the display. The measuring unit will appear on the
display also, appear under every test result.
Medisign Software Version 81-S1.0
Medisign GH83 BT User Manual
Blood Glucose Monitoring system
CONTENTS
About Your New System
Welcome
Intended Use
Application
Test Principle
Special Features
Usage and storage
Important Test Strip Information
Safety Information
Healthcare Professional Information
System Components
Testing Your Blood Glucose
Disinfection Before test
Performing a Blood Glucose Test
Flagging Test Results
Handling the Used Test Strip
Alternative Site Testing (AST)
Meter Setup, Memory and Downloading
Using Set-Up Mode
Deleting Test Results
Reviewing Test Results
Downloading Test Results to a PC
Before Pairing Your Meter
How to Pair Your Meter
Control Test
Performing Control Solution Test
Understanding Control Solution Test Results
Performing Check Strip Test
Maintenance and Troubleshooting
Cleaning your meter
Replacing Battery
Screen Message
Troubleshooting
Technical Information and Warranty
Specifications
Warranty
Symbols
EMC Test results
About Bluetooth
Additional Supplies
About Your New System
Welcome
Thank you for selecting the Medisign GH83 BT BGMS (Blood Glucose Monitoring System). Follow steps for
using the system in this manual. Before using your monitoring system for the first time, please read this manual
carefully.
Intended Use
The Medisign GH83 BT Blood Glucose Monitoring System is intended to be used for the quantitative
measurement of glucose in fresh capillary whole blood samples from the fingertips, palm and forearm. Venous
whole blood testing is limited to healthcare professionals use only. This system is intended for self-testing outside
of the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical
setting as an aid to monitor the diabetes control. This system is not for use in diagnosis or screening of diabetes
mellitus, nor for testing neonate or arterial blood samples. The alternative site testing (palm, forearm) should be
used only during steady- state conditions.
Application
Using fresh capillary whole blood and venous whole blood, Medisign GH83 Test Strips are for in vitro diagnostic
use only. Use the Medisign GH83 BT Meter in conjunction with your healthcare program.
Test Principle
Glucose in the blood sample reacts with FAD glucose dehydrogenase (FAD-GDH) on the test strip and a harmless
DC electrical current is produced. This current is measured by the Medisign Meter and displayed as your blood
glucose result. The strength of these currents changes with the amount of glucose in the blood sample. The
Medisign Meter automatically interprets this reaction. Blood glucose results from test strips that are plasmaequivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips.
CAUTION:
Medisign GH83 BT Meter is for use only with Medisign GH83 Blood Glucose Test Strips.
Special Features
• Accurate result in 6 seconds with using only 0.5㎕ blood sample.
• The Medisign GH83 BT system provides the auto coding feature.
• Store up to 300 test results.
• Your meter was set at the factory to the unit used in your country.
• Providing a Test Strip Ejecting Button.
Usage and Storage
• Before using your monitoring system, please place it in the environment of system's normal operating
temperature ranging 10~40℃ (50~104℉) for about 20 minutes.
• Store the system indoors between 4~30℃ (39.2~86℉).
• Recommended transport condition is 17~20℃ (62.6~68℉).
• The test should be performed in the indoors to obtain accurate results.
• Don't allow dust and foreign bodies into test strip slot in order to avoid affecting the system's accuracy.
• Don't decompose, demolish, repair or transform the system at any time. If the equipment is used in a manner not
specified by the manufacturer, the protection provided by the equipment may be impaired.
• Don't put the system near any electromagnetic field. (e.g. TV, microwave oven, mobile phone)
• Don't allow the monitoring system to collide with others during usage.
• Keep away from direct sunlight and humid environment for long time.
• Please use a soft cotton cloth to wipe the system.
• Don't use a corrosive product (e.g. Benzene, Acetone) to wipe the monitoring system.
• Applicable pollution degree of intended environment for this system is Pollution degree 2.
Important Test Strip Information
• Make sure to use your test strip immediately after retrieving it from the vial, be sure to keep the test strip vial
cap closed tightly at all times.
• For the most accurate results, make sure your hands are clean and dry before removing the test strips from their
vial.
• Do not use test strip that have expired, using expired test strips may cause inaccurate test results.
• For accurate results, fresh capillary whole blood and venous whole blood should be used. Arterial blood, plasma,
serum are not suitable for the test.
• Never reuse a test strip that is either blood or control solution applied. The Medisign Test Strip is for single use
only.
• This product is not recommended for pregnant women, newborns or if you are severe dehydration.
• Before the test you must make sure that the code number displayed on the meter matches the code number on
the test strip vial.
• Be sure to check the glucose measurement unit on the meter before the test.
• Make sure the cap of the test strip vial is closed tightly and store between 4~30℃ (39.2~86℉).
• Keep away from direct sunlight and heat. Do not freeze.
• Store test strips in their original vial only. If the cap is not closed, do not use the test strips for testing.
Safety Information
• Before using the system, please read this manual carefully.
• The meter and test strips should be handled at same temperature.
• For accurate results, keep the Medisign GH83 BT Blood Glucose Monitoring System operating temperature at
a range between 10~40℃ (50~104℉) for more than twenty (20) minutes before testing.
• Keep your meter, lancing device, lancets and control solution out of children.
• The test strips are external use. Do not swallow.
• Be sure to clean and disinfect your Blood Glucose Meter regularly.
• Do not reuse the test strips.
• Handle and dispose of the used test strip and lancet carefully.
• The Medisign GH83 BT Blood Glucose Monitoring System is for testing outside of the body (in vitro diagnostic
use).
• Close supervision in necessary when equipment is used by handicapped persons or invalids.
• In accurate results may occur for individuals or patient in shock.
• In accurate results may occur for individuals experiencing a hyperglycemic-hypersmolar state with or without
ketosis. Critically ill patients should not be tested with a blood glucose meter.
• This system may be used at altitudes up to 11,480 feet.
Healthcare Professional Information
Healthcare professionals performing blood glucose tests with this system on multiple patients must always wear
gloves and should follow the infection control policies and procedures approved by their facility
• When using the Medisign GH83 BT meter always follow the recognized procedures for handling objects that
are potentially contaminated with human material. Practice the health and safety policy of your laboratory or
institution.
• A drop of blood is required to perform a blood glucose test. Only capillary whole blood and venous whole blood
can be used.
• Avoid air bubbles when using pipettes.
• Refrigerated samples should be brought to room temperature slowly prior to testing.
The Medisign GH83 BT Blood Glucose Monitoring System
Medisign GH83 BT Meter
Medisign GH83 Test Strip
Explanation of Display
NOTICE: Each time you turn on the meter by inserting a test strip, the meter is performing several self-checks to
confirm that the meter is working properly.
Testing your Blood Glucose
Disinfectant before Test
• Before test, please clean hands with soap and water and then dry well.
• You can also use an alcoholic cotton cloth to clean finger.
• Please wait until the alcohol disappears completely.
Performing a Blood Glucose Test
1. Turn the cap counterclockwise to remove it.
2. Insert the lancet into the lancet holder and push down firmly until it is fully seated.
Do not twist the lancet.
3. Twist the protective disk until it separates from the lancet. Replace the lancing device cap. Turn
it clockwise until it is snug.
4. Insert a test strip to turn on the meter. Make sure it is inserted completely without bending the test strip.
5. The meter identifies the code number automatically. Compare the code number displayed on the LCD with the
code number on the test strip vial. If they do not match try again with an another test strip. If the problem persists,
please contact to Customer Service.
6. When the blood symbol appears, you can proceed with your test.
7. Adjust the puncture depth setting if necessary by turning the lancing device cap, number1 is the shallowest
depth while number 5 is the deepest. Slide the ejection/cocking control barrel back until it clicks. If it does not
click, the lancing device may have been cocked when the lancet was inserted..
8. Hold the lancing device firmly against your finger. Press the release button.
9. Gently squeeze your finger to assist the flow of blood. Do not squeeze excessively on the puncture site.
10. Hold the tip of the test strip to the drop of blood, the test strip will automatically draw the blood into the test
strip. When the test strip has enough blood the meter will beep and count down from five seconds. After five
seconds your test result will appear.
NOTICE:
When the blood sample is not sufficient, the display screen will show the massage of 'Er 4'. (Please refer to error
message in this manual).
CAUTION:
• Do not drop the blood directly on the end of the test strip.
• The sample channel at the end of the strip should show full. When you hear the beep sound, you have enough
blood in the test strip.
• Inaccurate results may occur for individuals or patient in shock. Inaccurate results may occur for individuals
experiencing a hyperglycemic-hypersmolar state, with or without ketosis. Critically ill patients should not be
tested with a blood glucose meter.
11. The test result will appear after the meter counts down from six (6) seconds. Keep the meter still while it is
counting down.
12. After six (6) seconds you will hear a second beep sound and your test result will be displayed on the LCD
screen. You can remove the test strip by pushing the test strip ejector on the back of the meter and the meter will
shut off automatically.
NOTICE:
If the test result is abnormal, please retest with new test strip. If the test result also has problem, please refer to the
Troubleshooting in this manual.
CAUTION:
•Never use a lancet that has been used by someone else.
•Do not leave the lancet in the device after use and dispose of the used lancet in a biohazard container always.
•Blood Glucose Meters are at high risk of becoming contaminated with blood-born pathogens such as Hepatitis
B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV). Transmission of these
viruses from resident to resident has been documented due to contaminated blood glucose devices. Accordingly,
cleaning and disinfecting of meters between resident uses can prevent the transmission of these viruses through
indirect contact.
•All parts of the kit are considered bio hazardous and can potentially transmit infectious diseases, even after you
have performed cleaning and disinfection.
•If you have taken the cap off of the lancet and the lancet has fallen to the ground, do not use it. Make sure you
dispose of it and replace it with a new lancet.
•Keep your Glucose Meter, Test Strips, Control Solution, Lancing Device and Lancets out of children at all times.
•Do not reuse lancets, lancets are for single use only.
•The meter and lancing device are for single patient use. Do not share them with anyone including other family
members. Do not use on multiple patients.
•User should wash their hands thoroughly with soap and water after handling the meter, lancing device or test
strips.
•Please see the section on “Cleaning your Meter” to clean the meter or lancing device.
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