GE GE100 User Manual

A Healthcare professional should be contacted when Customer Service is not available.

Please forward your warranty card to GE Diabetes Customer Support Center.
GE Diabetes Customer Support Center
1450 E. Spruce Street
Bldg. B
Ontario, CA91761, USA

Thank you for selecting the GE100 Blood Glucose Monitoring System. This manual provides all the
information you need to operate this product for accurate test results. Please read the entire manual
before you start any testing.

For people living with diabetes, it is important to regularly monitor blood glucose levels to effectively
reduce complications from the disease. The easy-to-use GE100 Blood Glucose Monitoring System
provides accurate, reliable results to help you better manage your diabetes.

The GE100 Blood Glucose Monitoring System is perfect for both self-testing and professional use.
Designed for in vitro diagnostic use only, testing requires just a small amount of fresh capillary whole
blood from either the fingertip, palm or forearm. If you have any questions regarding the GE100 Blood
Glucose Monitoring System or testing procedures, contact our Customer Support staff or your
healthcare professional.

The GE100 Blood Glucose Monitoring System is manufactured and supported by Bionime Corporation
and its authorized representative. If you have any questions or concerns, please

contact GE Diabetes

Customer

Support Center toll free at 1-866-613-7085 or visit our website at www.gediabetes.com. We

will make every effort to provide assistance and solutions for you.

Preface

32

Preface

Copyright © 2011 Bionime Corporation. All Rights Reserved Worldwide

- Before using the Blood Glucose Monitoring System to test your blood glucose, please read all the
instructions and conduct all the tests including the quality control test (Refer to page 36.)

- Please do the quality control test regularly to make sure the test results are accurate.

- The Blood Glucose Meter can only be used with the Blood Glucose Test Strips. 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 is intended for in vitro diagnostic use only. The testing
result is calibrated to be plasma equivalent to testing with fresh capillary whole blood samples from the
fingertip, palm and forearm.

- The Blood Glucose Monitoring System is intended for self-testing and professional use. It should
not be used to diagnose diabetes mellitus.

- Blood Glucose Monitoring System has not been validated for use on neonates. Therefore, it's not
intended for use on neonates.

- Blood Glucose Monitoring System has not been used for arterial blood testing yet, so it is not
suitable to be used for arterial blood testing.

-

- Follow all environmental protection regulations when disposing of batteries.

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- Do not perform a blood glucose test when USB cable is connected to the Blood Glucose Meter.

If the GE100 Blood Glucose Meter and Test Strips are exposed to a substantial change in temperature,
please wait 30 minutes before measurement.

Caution

54

Precaution

A minimum of 1.0µL of blood is needed for testing with the Blood Glucose Monitoring System.

Blood sample size above 3.0µL might contaminate the test strip port and the meter.

Blood sample size below 1.0µL might cause inaccurate test result or might not start the meter. In this

case, repeat the test with a new test strip.

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CAUTION

- The Blood Glucose Meter will be set to mg/dL by default when sold in the United States.
When your display shows " mmol/L " during setting or test, please contact customer service.
Use of the wrong unit of measure may cause incorrect treatment.

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Sample Size Example

- Avoid contact with dripping or splashing liquids.

- The minimum blood sample size to test using the Blood Glucose Monitoring System is 1.0µL. GE100

1.0µL 1.5µL 2.0µL 3.0µL 4.0µL

Table of Contents

76

Table of Contents

Quality Control

Quality Control Test.............................................................................................................................................................................34

Performing a Quality Control Test.................................................................................................................................................36

Test Memory

Recalling Test Results and Average..............................................................................................................................................38

Caring for Your Meter...........................................................................................................................................................................41

Error Messages and Trouble Shooting........................................................................................................................................42

Limitations................................................................................................................................................................................................46

Specifications..........................................................................................................................................................................................47

Warranty...................................................................................................................................................................................................49

Customer Service..................................................................................................................................................................................50

Expected Glucose Values Without Diabetes............................................................................................................................51

Essential Components List...............................................................................................................................................................52

Log Book...................................................................................................................................................................................................53

Warranty Card........................................................................................................................................................................................66

Emergency Card....................................................................................................................................................................................69

About The System

The Blood Glucose Monitoring System...........................................................................................................................8

The Blood Glucose Meter....................................................................................................................................................10

The Blood Glucose Test Strip............................................................................................................................................14

Before Testing

Meter Activation and Battery change.........................................................................................................................................16

Setting Up Your Meter - Setting the Time, Volume and Date...........................................................................................18

Turning On/Off the Meter..................................................................................................................................................................21

Handling the Test Strip........................................................................................................................................................22

Testing Procedure

Getting Ready for Testing..................................................................................................................................................................24

Performing a Blood Test....................................................................................................................................................................25

Display Window Appearance.... .......................... .......................... ................................................... .......................... ............31

Understanding Test Results and Messages..............................................................................................................................32

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9

10 ＊

53 ＊2

6 ＊

1

8

Your GE100 Blood Glucose Monitoring System consists of several items. Please identify each item, learn
its name and how it is used.

Below are the items included in your GE100 Blood Glucose Monitoring System:

1. Getting Started Guide

2. User's Manual (includes Log Book, Warranty Card & Emergency Card)

3. GE100 Blood Glucose Test Strip Package Insert ＊

4. GE100 Control Solution Package Insert ＊

5. GE100 Blood Glucose Meter (with 1 CR2032 batteries installed)

6. GE100 Blood Glucose Test Strips (0/10/25 pcs) ＊

7. GE100 Control Solution ＊

8. GE Lancing Device ＊

9. Clear Cap ＊

10. Disposable Sterile Lancets (10 pcs) ＊

11. Carrying Case (not shown) ＊

12. Instructions For The Lancing Device (not shown) ＊
(＊ Different packages have different bundled items. Some of packages might not include ＊ items.)

4 ＊

7 ＊

8 ＊

9 ＊

The Blood Glucose Monitoring SystemGE100 The Blood Glucose Monitoring SystemGE100

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Up Button
Down Button.

Main Button
.

The Blood Glucose MeterGE100

Display Window

Test Strip Port

Product name

Battery Cover

Meter Serial Number

Meter Battery

The Blood Glucose MeterGE100

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+

USB Port
(For data downloading on authorized
GE software only)

NOTE: Do not perform a blood glucose test when USB cable is connected to the Blood Glucose Meter.

1312

Indicates a test result stored in memory

Indicates a test result not included into the Average
function of this meter

Indicates the average result

Indicates a control solution test result

Unit of test result

Test result

Warns when the battery is low or must be replaced

Indicates when to apply the blood sample

Test strip

Occurs when strip is not compatible with your meter
or if a strip is inserted incorrectly.

Current date under time mode or testing date under
memory mode

Indicates if the environmental temperature limit is
exceeded during testing

Indicates the time in 12H format

Current time or testing time under
memory mode

under time mode

Manufacturing use only

The GE100 Blood Glucose Meter The GE100 Blood Glucose Meter

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CAUTION

Close the GE100 Blood Glucose Test Strip vial immediately after taking out a test strip.
Do not reuse GE100 Blood Glucose Test Strips.
Do not use expired GE100 Blood Glucose Test Strips .

- Discard the vial of test strips after 3 months from opening.
Store GE100 Blood Glucose Test Strips in a cool (39-86℉ or 4-30℃) and dry location (< 90%
relative humidity). Do not expose to direct sunlight or heat.
For detailed information, please refer to the GE100 Blood Glucose Test Strip Package Insert.

- If the GE100 Blood Glucose Meter and Test Strips are exposed to a substantial change in
temperature, please wait 30 minutes before measurement.

-

-

-

- When you open a new vial of GE100 Test Strips, record the date on the vial.

-

-

View Window

Hold here to insert
test strip into meter.

Electrode Contacts
Sensing signal output terminals.

Noble Metal Electrodes

Electrochemical sensor

Insertion Symbol

The GE100 Blood Glucose Meter can only be used with the GE100 Blood Glucose Test Strips.
The use of other test strips or control solutions can lead to incorrect results.

The GE100 Blood Glucose Test Strip The GE100 Blood Glucose Test Strip

Sample Port (Sample Entry)
Apply blood/Control Solution here.

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Meter Activation and Battery change

1. Turn the
Meter over. Press and slide
battery cover to open.

GE100 Blood Glucose

CAUTION

- Please follow the local regulation and discard a used battery properly.

4. The Meter will enter self-tesing mode automatically when replacing the battery (all symbols will show
on the screen).

5. Press any button to enter the Setting Mode.

6. You must set the time and date when replacing the battery. See Chapter "Setting Up Your Meter ­Setting the Time, Volume and Date". Test results are still stored in the memory.

3. Slide the battery cover
back until it snaps into
place.

2. Install the battery. Be sure to put
battery in correct direction
(polarity (+) facing up).

Meter Activation and Battery change

Your GE100 Blood Glucose Meter comes with one CR2032, 3volt , battery installed. One new battery will
provide power to perform about 1000 tests under normal use. Press the main button or insert a strip to
activate your meter.

You can enter Setting Mode two ways.

1. Replace Battery
After removing the battery, press the main button several times until there is no signal on screen,

then follow the battery installation steps to replace battery. The GE100 Blood Glucose Meter performs
a self-test. Press the main button to exit the self-test and enter Setting Mode.

2. With Battery Inserted
Press the main button first to turn on the GE100 Blood Glucose Meter. Hold down the main button for

7 Seconds. During this time the screen will go blank and then after hearing a beep it will turn on into
Setting Mode. The display screen will show setting data.

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Setting Up Your Meter- Setting the Time, Volume and Date

Setting Up Your Meter- Setting the Time, Volume and Date

1. Year setting
With the year format blinking, press the Up or Down button until you see the

current year. Press the Main button to confirm. Once the year is confirmed, the
Month setting will appear.

2. Month setting
With the month blinking, press the Up or Down button until you see the current

month. Press the Main button to confirm. Once the month is confirmed, the
Day setting will flash.

3. Day setting
With the day blinking, press the Up or Down button until you see the current

day. Press the Main button to confirm. Once the day is confirmed, the Time
setting will flash.

1)

2)

3)

4a) 4b)

5) 6)

7a) 7)

4. Time format 12/24H selection
With the time format blinking, press the Up or Down

button to switch between 12H and 24H. Press the Main
button to confirm your hour setting. Once confirmed, the
hour setting will flash.

5. Hour setting
With the hour blinking, press the Up or Down button until

you see the current hour. Press the Main button to confirm.
Once the hour is confirmed, the minute setting will flash.

6. Minute setting
With the minute blinking, press the Up or Down button

until you see the current minute. Press the Main button to
confirm. Once the minute is confirmed, the volume setting
will flash.

7. Volume setting
With the volume blinking, press the Up or Down button to

turn it on or off. Press the Main button to confirm and
finish the settings.

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NOTE

- If you do no change any settings during Meter Set-up for over 2 minutes, the GE100 Blood
Glucose Meter will leave setting mode and power off automatically.

Setting Up Your Meter- Setting the Time, Volume and Date

8. Ending setting
After the Volume Setting, the GE100 will return to the time screen. (If the
volume has not been turned off, you will hear a beep.)

1. How to turn on the GE100 Blood Glucose Meter
Press the Main button or insert a test strip.

2. Manual Power off
If you want to turn off the GE100 Blood Glucose Meter, press and hold the Main button for 3 seconds.

3. Auto Power off
The Blood Glucose Meter will power off automatically after 2 minutes if no buttons are pressed

or strip is inserted.

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Turning On/Off the Meter