GE 100 User Manual

Preface

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

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

contact GE Diabetes

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

Caution

- 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

GE100 GE100 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

GE100 result is calibrated to be plasma equivalent to testing with fresh capillary whole blood samples from the fingertip, palm and forearm.

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- The Blood Glucose Monitoring System is intended for self-testing and professional use. It should not be used to diagnose diabetes mellitus. GE100

- Blood Glucose Monitoring System has not been validated for use on neonates. Therefore, it's not intended for use on neonates. GE100

- 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. If the GE100 Blood Glucose Meter and Test Strips are exposed to a substantial change in temperature,

please wait 30 minutes before measurement.

- Follow all environmental protection regulations when disposing of batteries.

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

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Precaution

- Avoid contact with dripping or splashing liquids.

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

Sample Size Example

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.

CAUTION

- The Blood Glucose Meter will be set to mg/dL by default when sold in the United States.

GE100 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.

1.0µL 1.5µL 2.0µL 3.0µL 4.0µL

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Table of Contents

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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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

The Blood Glucose Monitoring SystemGE100 The Blood Glucose Monitoring SystemGE100

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.)

6 ＊

7 ＊

4 ＊

8 ＊

9 ＊

53 ＊2

10 ＊

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The Blood Glucose MeterGE100

Test Strip Port

Up Button Down Button.

Main Button .

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

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Display Window

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

Battery Cover

Product name

Meter Serial Number

Meter Battery

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The GE100 Blood Glucose Meter The GE100 Blood Glucose Meter

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

Manufacturing use only

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

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

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.

Electrode Contacts Sensing signal output terminals.

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Noble Metal Electrodes

Electrochemical sensor

Insertion Symbol

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

View Window

Hold here to insert test strip into meter.

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 .

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

- 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.

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.

1. Turn the

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

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 -

GE100 Blood Glucose Meter over. Press and slide battery cover to open.

on the screen).

Setting the Time, Volume and Date". Test results are still stored in the memory.

CAUTION

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

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

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

Meter Activation and Battery change

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

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.

4. Time format 12/24H selection

4a) 4b)

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

5) 6)

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.

7a) 7)

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

Turning On/Off the Meter

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.)

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.

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

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or strip is inserted.

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