GE GE006 Bedienungsanleitung

Preface

Thank you for selecting the GE006 Blood Glucose Monitoring System. This manual provides all the

information you need to operate this product for accurate test results. Please read this 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 GE006 Blood Glucose Monitoring System

provides accurate, reliable test results to help you better manage your diabetes.

The GE006 Blood Glucose Monitoring System is designed for in vitro diagnostic use only (for self-testing

by a single user outside the body). Testing requires only a small amount of fresh capillary whole blood

from either the fingertip, palm or forearm.

The GE006 Blood Glucose Monitoring System is manufactured and supported by Bionime Corporation. If

you have any questions or concerns, please contact your local Bionime Customer Service or call us at

886 0800 241 688 GMT+08:00, 08:30~17:30.

The GE006 Blood Glucose Monitoring System is a personal blood glucose monitoring system to be used

for self-testing only. It is not recommended for multiple users.

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

Caution

Precaution

- Before using the GE006 Blood Glucose Monitoring System to test your blood glucose, please read all of

the instructions and conduct all of the tests including the quality control test (Refer to page 37).

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

- The GE006 Blood Glucose Meter can only be used with GE006 Blood Glucose Test Strips. Other brands’

test strips should not be used under any circumstances. The use of other brands’ strips may give

inaccurate results.

- The GE006 Blood Glucose Monitoring System is intended for in vitro diagnostic use only. The GE006

Blood Glucose test results using fresh capillary whole blood samples from the fingertip, palm and

forearm are calibrated to be the equivalent to that of plasma testing.

- The GE006 Blood Glucose Monitoring System is intended for self-testing. It should not be used to

screen for or diagnose diabetes mellitus.

- If the GE006 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.

- Avoid contact with dripping or splashing liquids.

- The minimum blood sample size to test using the GE006 Blood Glucose Monitoring System is 0.75µL:

( )

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

Blood sample size below 0.75µL may cause an inaccurate result or may prevent a meter reading. An Er4

reading will be displayed if the sample size is too small. In this case, repeat the test with a new test strip.

Sample Size Example 0.75µL 1.0 1.5µL 2.0µLµL 3.0µL

Important Safety Notes:

- The GE006 Blood Glucose Meter and Lancing Device are for single patient use. Do not

share them with anyone including other family members.

- All parts of the kit are considered biohazardous and can potentially transmit infectious

diseases, even after following the cleaning and disinfecting procedures.

- Users should wash their hands thoroughly with soap and water before and after handling

the meter, lancing device, or test strips.

Please refer to the

section "Cleaning and Disinfecting Procedures" on page 47.

Table of Contents

About the Blood Glucose Monitoring System

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

The GE006 Blood Glucose Meter ................................................. ..................................

The GE006 Blood Glucose Test Strip ......................................................... .................

Before Testing

Meter Activation and Battery Change ............................................................................... .......

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

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

Turning On/Off the Bluetooth .............................................................................. .......................

Handling the GE006 Blood Glucose Test Strip ................................................ ..................................

Testing Procedure

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

Performing a Blood Glucose Test .............................................. .............................................

Setting Markers .......

Alternative Site Testing ......................................................... ..........................................................

View Window Appearance .................................................... ......................................................

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

GE006

GE006 ................................................. .........

.............................................................

...............................................................

................................................

.........................

................................................

...................................

................................................

...................................................

...........................................................................................................................................................................

................................................

.................................................

.............

Quality Control

About Quality Control Testing ......................................................................................................................................................

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

Understanding Control Test Results ..........................................................................................................................................

.....................................................

......................................................

.....................................................

..................................................

....................................................................................................................................................................

.........................................................................................

NCC 警語 ...............................................................................................................................................................................................

..................................................

.................................................

..................................................

Test Memory

Recalling Test Results ......................................................... .........................................................

Recalling Average Test Results ....................................................... ........................................

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

Cleaning and Disinfecting Procedures .............................................. .................................

Error Messages and Troubleshooting ................................................. ................................

Limitations ................................................................................................. ..........................................

Real Time Synchronize

Specifications ................................................................................................ ....................................

Warranty ......................................................................................................... .....................................

Customer Service .................................................................................................................. ............

Expected Blood Glucose Values Without Diabetes ........................................... ................

Component Manufacturer Information ........................................................... .......................

Log Book .......................................................................................................................... .....................

Warranty Card ...................................................................................................................... .............

Emergency Card ..................................................................................................... ..........................

FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT

10 ＊

53 ＊2

6 ＊

4 ＊

7 ＊

8 ＊

9 ＊

The GE006 Blood Glucose Monitoring System

Contents

Your GE006 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 GE006 Blood Glucose Monitoring System:

1. Getting Started Guide

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

3. GE006 Blood Glucose Test Strip Package Insert ＊

4. Rightest® Control Solution GC550 Package Insert ＊

5. GE006 Blood Glucose Meter ( with 2 AAA batteries installed )

6. GE006 Blood Glucose Test strips ( 10/25 pcs )＊

7. ＊

8. Lancing Device ＊

9. Clear Cap ＊

10. Disposable Sterile Lancets ( 10 pcs ) ＊

11. Carrying Case ( not shown )＊

12. Instruction for the lancing device ( not shown )＊

(＊ Different packages have different bundled items. Some of packages might not include ＊ items.)

＊

Rightest® Control Solution GC550

Rightest® GD500

The GE006 Blood Glucose Monitoring System

If you want to purchase optional items, please contact the Customer Support Center at

866-0800-241-688.

1110

The Blood Glucose MeterGE006 The Blood Glucose MeterGE006

Left Button ( )

Main Button ( )

Display Window

Right Button ( )

Test Strip Port

Meter Battery

Product name

Battery Cover

Meter Serial Number

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

Indicates the time in 12H format

The GE006 Blood Glucose Meter The GE006 Blood Glucose Meter

Appears when an error occurs

Appears after you insert test strip into meter

Current date under time mode or testing date under

memory mode

Warns when the operational temperature limit is

exceeded during testing

Displays current time under time mode or testing time

under memory mode

Manufacturing use only

Indicates a meal marker with test result

Indicates that the Bluetooth is turned on

Indicates that the Bluetooth is turned off

Indicates the time period of test results

1514

The GE006 Blood Glucose Test Strip The GE006 Blood Glucose Test Strip

The GE006 Blood Glucose Meter can only be used with GE006 Blood Glucose Test Strips and Rightest™

Control Solution GC550. The use of other test strips or control solutions can lead to incorrect results.

Sample Port

Apply blood/control solution here.

Noble Metal Electrodes

Electrochemical sensor

View WIndow

PRECAUTION

- Close the GE006 Blood Glucose Test Strip vial immediately after removing a test strip.

- Do not reuse GE006 Blood Glucose Test Strips.

- Do not use expired GE006 Blood Glucose Test Strips.

- When you open a new vial of GE006 Blood Glucose Test Strips, record the date on the vial.

Discard the vial of test strips after 3 months from opening.

- Store the GE006 Blood Glucose Test Strip between 4-30°C (or 39-86°F) and in a location (<

90% relative humidity). Do not expose to direct sunlight or heat.

- If the GE006 Blood Glucose Meter and Test Strips are exposed to a substantial change in

temperature, please wait 45 minutes before measurement.

- For detailed information, please refer to the GE006 Blood Glucose Test Strip Package

Insert.

Electrode Contacts

Hold here to insert

test strip into

meter.

Meter Activation and Battery Change

Your Blood Glucose Meter comes with two AAA, batteries installed. Two new batteries will

provide power to perform approximately 800 tests under normal use with one data transfer. Press the

main button or insert a strip to activate your meter.

GE006

4. The GE006 Blood Glucose Meter

5. Press any button to exit the self-test and enter Setting Mode.

will enter Self-Testing Mode automatically when replacing the battery

(all symbols will appear on the screen).

6. You must set the time and date when replacing the battery. See Chapter “Setting Up Your Meter -

Setting the Date, Time, and Volume" on page 18. Test results are still stored in the memory.

1. Turn the

over. Press and slide the

battery cover to open.

GE006 Blood Glucose

Meter

2. Install the batteries. Be sure to

put the batteries in the correct

direction.

3. Slide the battery cover

back until it snaps into

place.

Meter Activation and Battery Change

CAUTION

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

- Risk of explosion if battery is replaced by an incorrect type.

You can enter the Setting Mode two ways.

1. Replace the Battery

2. With Battery Inserted

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 GE006 Blood Glucose Meter will

perform a self-test. Press the main button to exit the self-test and enter the Setting Mode.

Press the main button to turn on the GE006 Blood Glucose Meter. Hold down the main button for 7

seconds. During this time the screen will go blank until you hear a beep. After the beep, the meter will

turn on into the Setting Mode. The display screen will show setting data.

NOTE

- Use the Left and Right buttons to select your setting data and press the main button to

confirm each selection. After confirming all of the settings, you will return to the Time Mode.

1918

4a) 4b)

5) 6)

1. Year setting

, press the Left or Right button until you see the

current year. Press the Main button to confirm.

2. Month setting

With the month blinking, press the Left or Right button until you see the

current month. Press the Main button to confirm.

With the year format blinking

Once the year is confirmed, the

Month Setting will appear.

Once the month is

confirmed, the Day Setting will appear.

Once the day is confirmed, the Time

Setting will appear.

3. Day setting

With the day blinking, press the Left or Right button until you see the current

day. Press the Main button to confirm.

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

4. Time format 12/24H selection

With the time format blinking, press the Left or Right

button to switch between 12H and 24H. Press the Main

button to confirm.

5. Hour setting

With the hour blinking, press the Left or Right button until

you see the current hour. Press the Main button to

confirm.

6. Minute setting

With the minutes blinking, press the Left or Right button

until you see the current minute. Press the Main button to

confirm.

Once confirmed, the Hour Setting will

appear.

Once the hour is confirmed, the Minute Setting

will appear.

Once the minute is confirmed, the Volume

Setting will appear.

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