Rightest BIONIME GM300 User manual

USER’S MANUAL
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
http: //www.bionime.com
E-mail: [email protected]om
101-3GM300-0S1 EN
BIONIME GmbH
Tramstrasse 16, 9442 Berneck
Switzerland
E-mail: [email protected]
GM300
Blood Glucose Monitoring System
0197
Rev. Date: 2017-01

Thank you for selecting the Blood Glucose Monitoring System GM300. Please read this
manual thoroughly before you start testing. It provides all the information you need to use the
product. You will get a correct test result by the following instruction of this manual.
It is quite important for you to monitor blood glucose regularly. A derived complication can thus be
effectively reduced. Through the assistance of Blood Glucose Monitoring System GM300,
which provides considerate design and accurate results, your diabetes management can become
more reliable and ease-to-use.
The Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use ( For
self-testing & professional use ) only ( outside the body ). The testing result is calibrated to plasma
equivalent with whole blood from capillary. Capillary whole blood can sample from the fingertip, palm
or forearm. You may consult your healthcare professional for instructions on how to use the system
correctly. Our Customer Support staff is available to assist you as well.
The Blood Glucose Monitoring System was manufactured and supported by Bionime
Corporation and its authorized representative. If you have any questions or concerns, please contact
your Bionime authorized representative or email to [email protected]. We will make every effort
to provide assistance and solutions for you.
Please forward your warranty card to Bionime authorized representative to activate your warranty
coverage.
Preface
32
Preface

- Before using the GM300 to test your blood glucose, please read all the instructions and
practice the tests including quality control test. ( Refer to page 46.)
- Please do the quality control test regularly to make sure the test results are accurate .
- The Blood Glucose Meter GM300 can only be used with the Blood Glucose
Test Strips GS300. The use of any other brand Strips should not be used under any circumstances.
The use of other brands of strips may give inaccurate results.
- The Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use only.
The testing result is calibrated to be plasma equivalent for test with fresh capillary whole blood
samples by finger stick.
- The Blood Glucose Monitoring System GM300 is intended for self-testing. It should not
be used to diagnose diabetes mellitus.
- The Blood Glucose Monitoring System GM300 has not been validated for use on
neonates. Therefore, it's not intended for use of neonates.
Precaution
54
Precaution
- The Blood Glucose Meter GM300 hasn't been used for arterial blood testing yet, so it is
still not suitable to be used for arterial blood testing so far.
- Do the test at least 30 minutes after while entering another site with different ambient temperature.
- Pay attention to the environment protection when disposal of batteries.
- Perform blood glucose testing between 10 ~ 40 ℃ ( 50 ~ 104 ℉).
- Keep your meter and test strip free of dust, water or any other liquid.
- The minimum blood sample size of Glucose Monitoring System GM300 is 1.4 µL :( )
1.0 1.4 2.0 3.0 µL µL µL µL 4.0 µL
We suggest you to take 1.4~2.5 µL to do the test on glucose monitoring system. Blood sample size
above 4.0 µL might contaminate the Smart Code Key.
Blood sample size below 1.4 µL might cause inaccurate test result or might not start on meter
measurement. In this case, repeat the test with a new test strip.
Sample Size Example

About System
The Blood Glucose Monitoring System
The Meter
The Test Strip
Dummy Code Key
The Smart Code Key
Table of Contents
76
Table of Contents
Testing Procedure
Getting Ready for Testing
Performing a Test in Order
Comprehending Test Results and Messages
Review Your Test Memory
Recalling Your Test Result
Recalling Your Average Test Result
Quality Control
About Quality Control Test
Performing a Quality Control Test
Understanding Control Test Results
Caring for Your Meter
Error Messages and Trouble Shooting
Limitations
Specification
Warranty
55
56
59
60
62
63
64
65
76
79
46
49
54
43
45
32
33
41
20
22
24
28
29
30
8
10
16
18
19
Customer Service
Parts of Critical Component
Log Book
Warranty Card
Emergency Card
Being Ready for Test
Smart Code Key Installation
Batteries Installation
Setting Up Your Meter
Turning On/Off the Meter
Function Screens and Button Operations
Easily Handling the Test Strip
About System GM300
The Blood Glucose Monitoring System GM300
The Meter GM300
The Test Strip GS300
Dummy Code Key
The Smart Code Key

9
Test Str ip s
11＊
532
7 ＊
16
8 ＊
9
The Blood Glucose Monitoring System GM300
8
Package of Meter Kit
Your Blood Glucose Monitoring System GM300 consists of several items. Please identify
each item of your system and learn what they're called and how they're used.
These items are included in your Blood Glucose Monitoring System :
1. Getting Started Guide
2. GM300 User's Manual ( includes Log Book, Warranty Card, Emergency Card )
3. Blood Glucose Test Strip GS300 Package Insert
4. Control Solution Package Insert ＊
5. Meter GM300
6. Dummy Code Key ( for the package without strip ) or Smart Code Key pre-installed
( for the package with strip )
7. GS300 Test strips ( 0/10/25 pcs )＊
8. Control Solution ＊
9. Check Key
10. Lancing Device ＊
11. Disposable Sterile Lancets ( 10 pcs ) ＊
12. Carrying Case ( not shown )＊
13. Two AAA Batteries ( not shown )＊
14. Instruction for the lancing device ( not shown )＊
(＊ Different packages have different bundled items. Some of packages might not include ＊ items.)
The Blood Glucose Monitoring System GM300
4 ＊
10 ＊
2017-12

Main Button ( )
Press to turn on/off meter.
Switch different function screen.
Press and hold down until enter to the setting mode.
( There will be a power-off period during this process.)
The Meter GM300
1110
The Meter GM300
Test Strip Port
Insert test strip here until you hear a click.
Smart Code Key
For calibrating your meter. New one comes with every box
of test strips. ( Refer to page )
Contain the test strip port for inserting strip.
Assemble Smart Code Key into code key base.
19
Display Window
Show your test result, messages and relative information.
Up Button ( )
Down Button ( )
Press to review stored test value in memory and average.
Select the function mode.

1312
Please follow the step ① and step ②.
CODE: 063
Model Number
Smart Code Key Base
Assemble Smart Code Key here Battery Cover
Slide cover to change batteries.
Smart Code Key Release Button
Press down to release and switch the
Smart Code Key.
Meter Serial Number
The Meter GM300 The Meter GM300

15
14
Indicates a test result stored in memory
Indicates the average result
Unit of test result
Test result
Indicates when to apply the blood sample
Indicates a strip is inserted
Appears when an error occurs
Warns when the operational temperature limit is
exceeded during testing
Indicates the time in 12H format
Manufacturing use only
Indicates in the control solution mode
Warns when the batteries are low or must be
replaced
Indicate the code of Smart Code Key
Indicates a check key is inserted
Displays current date / time under time mode or
testing date / time under memory mode
The Meter GM300 The Meter GM300

The Test Strip GS300
1716
The Test Strip GS300
PRECAUTION
- Re-cap the vial cap immediately and close tightly after taking test strip out from the vial.
- Do not reuse test strips.
- Do not use expired test strips.
- Check the discard date you wrote on the vial label every time you use the strip.
- Store the test strip in a cool, dry place and avoid the exposure of direct sunlight and heat.
- For detailed information, please refer to the Test Strip Package Insert.
View Window
This window is originally yellow
before applying blood sample.
It will gradually become red
after filled with blood drop.
Hand Bar
Where you can easily
hand the strip to do
the test.
Sample Entry
µL
Apply a drop of blood or control solution here.
The test request is only 1.4 of blood.
Electrode Contacts
Sensing signal output terminals.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with indication symbol
up and toward meter.
The blood sample will be drawn into
sample entry by capillarity automatically.

For package without test strip, not for package with test
strip
A Dummy Code Key will be installed on the new meter in the
package without test strip. This Dummy Code Key is not intended to be used
for testing.
When you open a new box of test strips, you have to replace the Dummy
Code Key by new Smart Code Key in the box.
Do not throw away this Dummy Code Key. It can be used to keep the Smart
Code Key Base clean while the Smart Code Key is not installed.
Dummy Code Key
1918
The Smart Code Key
What is Smart Code Key ?
Smart Code Key is designed to calibrate your meter to make each lot of
strips have the same performance. Each new box of strips contains its new
Smart Code Key. The Smart Code Key stores calibrated information that your
meter needs to give you accurate blood glucose results. You must change
your Smart Code Key with each new box of GS300 Test Strips.
Smart Code Key also contains the test strip port. Although you can still review
the memory and other settings, it's necessary to assemble the Smart Code
Key into meter before actually starting your test. This procedure makes sure
you do calibrate the meter and assures you of getting accurate test results.