Bionime GM232 User Manual

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:

( )

Sample Size Example

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.

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. section "Cleaning and Disinfecting Procedures" on page 47.

- Users should wash their hands thoroughly with soap and water before and after handling the meter, lancing device, or test strips.

0.75µL 1.0 1.5µL 2.0µLµL 3.0µL

Please refer to the

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

Quality Control

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

GE006

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

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8 10 14

16 18 21 22 23

25 26 31 32 34 35

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

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

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 FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT

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

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

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

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

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

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

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

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

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

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40 42

43 45

46 47 51 55 56 58 60 61 63 64 65 66 67 82 85

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 )＊ Rightest® Control Solution GC550

7. ＊ Rightest® GD500

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.)

＊

4 ＊

6 ＊

7 ＊

If you want to purchase optional items, please contact the Customer Support Center at 866-0800-241-688.

8 ＊

9 ＊

53 ＊2

10 ＊

The Blood Glucose MeterGE006 The Blood Glucose MeterGE006

Test Strip Port

Display Window

Left Button ( )

Main Button ( )

Right Button ( )

Battery Cover

Product name

Meter Serial Number

Meter Battery

1110

The GE006 Blood Glucose Meter The GE006 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

Indicates a meal marker with test result

Indicates that the Bluetooth is turned on

Manufacturing use only

Indicates when to apply the blood sample

Appears after you insert test strip into meter

Appears when an error occurs

Current date under time mode or testing date under memory mode

Warns when the operational temperature limit is exceeded during testing

Indicates the time in 12H format

Displays current time under time mode or testing time under memory mode

Indicates that the Bluetooth is turned off

Indicates the time period of test results

1312

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.

Electrode Contacts

Sample Port

Apply blood/control solution here.

PRECAUTION

Noble Metal Electrodes

Electrochemical sensor

View WIndow

Hold here to insert test strip into meter.

- 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.

1514

Meter Activation and Battery Change

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

GE006 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.

1. Turn the

4. The GE006 Blood Glucose Meter

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

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

GE006 Blood Glucose

over. Press and slide the

Meter battery cover to open.

(all symbols will appear on the screen).

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

CAUTION

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

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

2. Install the batteries. Be sure to put the batteries in the correct direction.

will enter Self-Testing Mode automatically when replacing the battery

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

You can enter the Setting Mode two ways.

1. Replace the 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 GE006 Blood Glucose Meter will perform a self-test. Press the main button to exit the self-test and enter the Setting Mode.

2. With Battery Inserted

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.

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

1. Year setting

With the year format blinking

current year. Press the Main button to confirm.

, press the Left or Right button until you see the

Once the year is confirmed, the

Month Setting will appear.

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.

Once the month is

confirmed, the Day 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.

Once the day is confirmed, the Time

Setting will appear.

4. Time format 12/24H selection

4a) 4b)

With the time format blinking, press the Left or Right button to switch between 12H and 24H. Press the Main button to confirm.

Once confirmed, the Hour Setting will

appear.

5. Hour setting

With the hour blinking, press the Left or Right button until you see the current hour. Press the Main button to

Once the hour is confirmed, the Minute Setting

confirm.

5) 6)

will appear.

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 the minute is confirmed, the Volume

Setting will appear.

1918

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

Turning On / Off the Meter

7. Volume Setting

With the volume blinking, press the Left or Right button to turn the volume on or off. Press the Main button to confirm and finish the settings.

8. Setting the Unit of Measurement

With milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L) blinking, press the Left or Right button to switch. Then press the Main button to confirm it and finish the settings.

9. Ending setting

After measurement of unit setting, for confirmation you will hear a beep (if volume is turned on). All the settings are saved and completed and will return to time screen.

NOTE

- If you do not change any settings during Meter Set-up for over 2 minutes, the GE006 Blood Glucose Meter will leave setting mode and power off automatically.

7a) 7b)

8a) 8b)

1. How to turn on the GE006 Blood Glucose Meter Press the Main button or Insert a test strip.

2. Manual Power off

To power off the GE006 Blood Glucose Meter, press and hold the Main button for 4 seconds.

3. Auto Power off

The GE006 Blood Glucose Meter will power off automatically after 2 minutes if no buttons are pressed

or no strip is inserted.

2120

Turning On/ Off the Bluetooth

Handling the GE006 Blood Glucose Test Strip

1. Auto turn on the Bluetooth

After leaving the Setting mode, the Bluetooth will turn on automatically and the

" " symbol blinks on the screen.

2. Turn off the Bluetooth In Time mode, press and hold the Right or Left button for two seconds. The

blinking " " symbol will switch to the “ “ symbol with a beep (If Volume is turned on).

3. Manual turn on the Bluetooth In Time mode, press and hold the Right or Left button for two seconds. The

“ “ symbol will switch to the blinking “ “ symbol with a beep (If Volume is turned on).

NOTE

1.The blinking symbol should turn to steady immediately when the Bluetooth connection is established.

2. Blinking back and forth “ “ symbol on the screen means the

meter is transferring data.

“ “

How to handle the GE006 Blood Glucose Test Strip.

Inserting the GE006 Blood Glucose Test Strip:

1. Hold the GE006 Blood Glucose Test Strip between your thumb and middle finger with the view window " " facing up.

2. Put your forefinger on the side of the strip as shown.

3. Insert the GE006 Blood Glucose Test Strip into test strip port until it clicks and firmly stops.

Handling the GE006 Blood Glucose Test Strip

Getting Ready for Testing

Removing the GE006 Blood Glucose Test Strip:

1. Hold the GE006 Blood Glucose Test Strip as shown.

2. Rotate the GE006 Blood Glucose Test Strip counterclockwise and pull up simultaneously.

3. Take the GE006 Blood Glucose Test Strip out of the test strip port. Please follow your health care professional's direction and discard used strips properly.

Before performing a blood glucose test, prepare the items below :

- GE006 Blood Glucose Meter

- GE006 Blood Glucose Test Strips (Please check the expiration date on the test strip vial. Do

not use expired test strips)

- Rightest™ GD500 Lancing device

- Sterile lancet

- Alcohol swab (optional)

Depth adjustable cap

Lancet carrier

Release button

PlungerBase

+ 30 hidden pages

Bionime GM232 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual