Bionime GM782 User Manual

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BIONIME CORPORATION

No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Tel: +886 4 2369 2388 Fax: +886 4 2261 7586 http: //www.bionime.com E-mail: [email protected]

BIONIME GmbH

Tramstrasse 16, 9442 Berneck Switzerland E-mail: [email protected]

0197

Rev. Date: September/2014

101-3GM782-XXX

Blood Glucose Monitoring System GM782

GM782

USER’S MANUAL

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Preface

Thank you for selecting the 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 Blood Glucose Monitoring

GM782

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

Rightest GM782

The 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.

Venous, arterial, and neonatal blood testing is limited to healthcare professional use only.

Rightest GM782

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Rightest GM782

The 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.

The testing result is calibrated to be plasma equivalent for test with fresh capillary, venous, arterial and neonatal whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm, and in the case of neonates, the heel. 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.

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

Please forward your warranty card to customer support to activate your warranty coverage.

Rightest GM782The Blood Glucose Monitoring System is manufactured and supported by Bionime Corporation. If you have any questions or concerns, please contact your local Customer

Bionime

Customer Service or call us at +886-0800-371-688 GMT+08:00, 08:30~17:30.

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Caution Caution

- Before using the 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 Blood Glucose Meter can only be used with Blood Glucose

Rightest GM782 Rightest Test Strips . use of other brands’ strips may give inaccurate results.

The Rightest Blood Glucose Monitoring System GM782 is intended for in vitro diagnostic use

only. The Rightest 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. Venous, neonatal or arterial blood may also be used only if drawn by healthcare professionals.

- The Blood Glucose Monitoring System is intended for self-testing. It should not

Rightest GM782 be used to diagnose diabetes mellitus.

- If the Rightest Blood Glucose Meter GM782 and Test Strips GS700 are exposed to a substantial change in temperature, please wait 30 minutes before measurement.

- Follow all environmental protection regulations when disposing of batteries.

Rightest GM782

TM TM

GS700 Other brands’ test strips should not be used under any circumstances. The

- Avoid contact with dripping or splashing liquids.

- The minimum blood sample size to test using the Blood Glucose Monitoring System

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.

The system has been tested with neonatal blood. As a matter of good clinical practice, caution is advised in the interpretation of neonate glucose value below 50 mg/dL. Please follow the recommendations for follow-up care that have been set by your intuition for critical glucose values in neonates. Results for neonates exhibiting symptoms of galactosemia should be confirmed by laboratory tests.

is 0.75µL: ( )

GM782

0.75µL 1.0µL 1.5µL 2.0µL 3.0µL

Important Safety Notes:

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

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Table of Contents

About the Blood Glucose Monitoring System

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

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

The 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....................................................................................................................

Handling the 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......................................................................................

Rightest GM782

Rightest GS700

8 10 14

16 18 22 23

25 26 31 34 36 37

Quality Control

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

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

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

Test Memory

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

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

Caring for Your

Meter...................................................................................................................................................

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

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

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

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

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

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

Federal Communications Commission (FCC)Statement..................................................................

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

39 42 44

45 46

48 49 53 54 56 57 58 59 60

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The Blood Glucose Monitoring System

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The Blood Glucose Monitoring System

Rightest GM782

Contents

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Your Blood Glucose Monitoring System GM782 consists of several items. Please

identify each item, learn its name and how it is used.

Below are the items included in your Blood Glucose Monitoring System GM782:

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1. Getting Started Guide

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

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3. Blood Glucose Test Strip GS700 Package Insert ＊

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4. Control Solution GC700 Package Insert ＊

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

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6. Blood Glucose Test strips GS700 ( 10/25 pcs )＊

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7. Control Solution GC700 ＊(Normal Level is provided in your starter kit)

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8. Lancing Device ＊

GM782

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.)

6 ＊

7 ＊

4 ＊

8 ＊

9 ＊

53 ＊2

10＊

GM782

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The Blood Glucose Meter

Rightest GM782

GM782

Test Strip Port

The Blood Glucose Meter

Rightest GM782

Display Window

Left Button ( )

Main Button ( )

Right Button ( )

GM782

Battery Cover

Meter Battery

2D barcode with serial number

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The Blood Glucose Meter

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The Blood Glucose Meter

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Indicates a test result stored in memory

Indicates a test result not included into the average results of the meter

Indicates the average result

Indicates a control solution test result

Unit of test result

Test result

Warns when the batteries are low or must be replaced

indicates that the Bluetooth is turned off indicates that the Bluetooth is turned on

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 or testing time under memory mode

Manufacturing use onlyindicates a meal marker with test result

under time mode

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The Blood Glucose Test Strip GS700

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The Blood Glucose Test Strip GS700

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The Blood Glucose Meter G 782 can only be used with Blood Glucose Test

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Strips GS700 and Control Solution GC700. The use of other test strips or control

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solutions can lead to incorrect results.

Sample Entry

Apply a drop of blood or control solution here. The test request is only 0.75 of blood.

Noble Metal Electrodes

Electrochemical sensor

µL

Hand Bar Grip here to insert test strip into the strip port of auto

Indication Symbol Insert strip with indication symbol up and toward meter.

View Window This window is yellow before applying blood

code key.

sample. It gradually turns red when filled with blood.

Electrode Contacts Sensing signal output terminals.

PRECAUTION

- Close the lood Glucose Test Strip GS700 vial immediately after removing a

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test strip.

- Do not reuse .

- Do not use expired .

When you open a new vial of Rightest Blood Glucose Test Strip GS700, record the date

on the vial.

- Store the in a cool ( 39-86°F or 4-30°C ) and

Rightest Blood Glucose Test Strip GS700

dry location (< 90% relative humidity). Do not expose to direct sunlight or heat.

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

- For detailed information, please refer to the Rightest Blood Glucose Test Strip GS700

Rightest Blood Glucose Test Strip GS700

Discard the vial of test strips after 4 months from opening.

Rightest Blood Glucose Test Strip GS700

GM782

Package Insert.

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Meter Activation and Battery Change

GM782

GM782GM782

GM782

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Your Blood Glucose Meter comes with one CR2032, 3volt, batteries installed. one

new batteries will provide power to perform approximately 1000 tests under normal use. Press

the main button or insert a strip to activate your meter.

GM782

Meter Activation and Battery Change

1. Turn the

4. The 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 -

GM782 Blood Glucose Meter and slide the battery cover to open.

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replacing the battery (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.

over. Press

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

GM782 will enter Self-Testing Mode automatically when

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

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

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 Rightest Blood Glucose Meter

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

GM782

Mode.

2. With Battery Inserted

Press the main button to turn on the Rightest Blood Glucose Meter . Hold down the

GM782 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.

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.

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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.

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 confirm.

Once the hour is confirmed, the Minute Setting

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.

4a) 4b)

7. Volume Setting

7a) 7b)

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

8a) 8b)

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.

(If Volume is turned off, the display will directly return to time screen without a sound of “beep”.)

NOTE

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

GM782

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Turning On / Off the Meter

GM782

Handling the Blood Glucose Test Strip

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GS700

1. How to turn on the Blood Glucose Meter

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GM782

Press the Main button or Insert a test strip.

2. Manual Power off

To power off the Blood Glucose Meter , press and hold the Main button for 3

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GM782

seconds.

3. Auto Power off

The Rightest Blood Glucose Meter will power off automatically after 2 minutes if no

GM782

buttons are pressed or no strip is inserted.

How to handle the ood Glucose Test Strip .

Inserting the Blood Glucose Test Strip :

1. Hold the Blood Glucose Test Strip between your thumb

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GS700

and middle finger with the view window " " facing up.

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

3. Insert the Blood Glucose Test Strip into test strip port

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GS700

until it clicks and firmly stops.

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GM782

Handling the Blood Glucose Test Strip

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GS700

Getting Ready for Testing

Removing the Blood Glucose Test Strip :

1. Hold the Blood Glucose Test Strip as shown.

2. Rotate the Blood Glucose Test Strip counterclockwise

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GS700

and pull up simultaneously.

3. Take the Blood Glucose Test Strip out of the test strip

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GS700

port.

Please follow your local regulations and discard used strips properly.

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

- Blood Glucose Meter

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- Blood Glucose Test Strips

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GM782

GS700

GM782

(Please check the expiration date on the test strip

vial. Do not use expired test strips)

- Lancing device GD500

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- Sterile lancet

- Alcohol swab (optional)

Depth adjustable cap

Release button

PlungerBaseLancet carrier

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Performing a Blood Glucose Test

1. Hold the depth adjustable cap in one hand and hold the base with the other hand. Bend the cap down. When a gap appears between the cap and base, pull the cap and base in opposite directions.

2. Pull off the depth adjustable cap.

3. Insert a new disposable lancet firmly into lancet carrier.

4. Twist off and set aside the protective cover of the

disposable lancet.

5. Replace the depth adjustable cap.

6. Choose a depth of penetration by rotating the top portion of the depth adjustable cap until your desired setting is visible in the window. Settings are based on skin type " " for soft or thin skin; " " for average skin;

" " for thick or calloused skin.

1 2

7. Hold the base in one hand and pull on the plunger with

8 the other hand. The device will be cocked. Release the plunger and it will automatically move back to its original position near the base.

8. Wash your hands with warm soapy water and dry thoroughly.

from the vial. Close the vial cap immediately.

9. Take one Blood Glucose Test Strip GS700

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10. Insert the strip into the test strip port of the

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Blood Glucose Meter GM782 with the view window facing up.

11. Once the strip is inserted, all symbols will appear on your meter display and will be accompanied by a beep (if volume is turned on).

NOTE

Rightest Blood Glucose Meter GM782

- The will

automatically detect the Code number on the test strip. You do not have to check the Code number on the meter display and strip vial.

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Performing a Blood Glucose Test

GM782

Performing a Blood Glucose Test

12. A blood drop icon will appear on the display window

and will be accompanied by a beep (if volume is turned

on). Apply the blood sample within 2 minutes.

13. Place the lancing device against your fingertip and

press the release button.

14. Touch and hold the blood drop to the edge of sample

port until the view window is filled with blood. If the view

window is not completely filled with blood the test will

not start. If the blood sample was insufficient, discard

the test strip and repeat with a new Blood

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Glucose Test Strip GS700.

15. Countdown Mode will begin on the display window. After

5 seconds, your test result will appear.

14a

14c

14b

16. Pull off the depth adjustable cap. Without touching the used disposable lancet, insert the lancet tip into the protective lancet cover.

17. Hold the release button in one hand (see picture 17, step

1) and pull on the plunger with the other hand (see picture 17, step 2) to safely eject the used disposable lancet.

18. Discard the used disposable lancet into an appropriate puncture-proof or biohazard container.

19. Replace the depth adjustable cap after finishing the test.

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Performing a Blood Glucose Test

Setting Markers

CAUTION

- Do not apply your blood drop to the sample port on the strip until you see the " " appear.

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The Blood Glucose Meter is performing an internal test and will display " " and " " if you apply blood too soon. If this occurs, please repeat the test with a new test strip.

- Record the opening date of a new test strip vial. Discard the vial of test strips 4 months after opening.

- Always keep the metal contacts of the test strip port clean. If any dust or impurities are present, please clean with a small, soft brush.

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- The Blood Glucose Monitoring System GM782 and Lancing device GD500 are intended for a single user only. Do not share these devices with anyone, including other family members.

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

TM TM

GM782

According to actual life status, you can set meal markers with test result. You have to perform meal marker setting immediately after the meter displays the reading of your test result.

1. After test, the test result is displayed on the screen with time, date and flashing “ ”.

2. Keep pressing the Right button to choose between the “ ” (before meal), “ ” (after meal), ” ” (no marker) and “ ” then press main button to confirm and save this record.

Before meal: You execute this blood glucose test before a meal.

After meal: You execute this blood glucose test after a meal.

(Blank) no marker: regular test or definition by user.

No average: You will exclude this test result from average calculation. Please refer to "Excluding test results from the average calculation"on page 44 for more information.

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Upload Data

Airplane Mode

After the marker setting, Bluetooth will turn itself on and start to pair with your mobile device or PC. Once the connection successfully pairs, test results will start uploading to the connected mobile device or PC. When the test result uploading has completed, Bluetooth will turn itself off.

Bluetoot h pa ir ing. The symbol o f Bl ue tooth flashes.“ ”

NOTE

1.Users don't need to manually turn the Bluetooth on.

2.The meter only stays in pairing mode for 20 seconds, and then turns Bluetooth off

and returns to Time Mode.

323534

Data uploading.

The GM782 meter is now uploading test results

to your mobile device or PC.

Turn on Airplane Mode

Press on the right or left button for 3 seconds to turn it on. When airplane mode is on, you'll see

on the screen. In Airplane Mode, the Bluetooth feature for test results uploading is turned off.“ ”

Airplane Mode

The symbol appears in the left corner on screen.“ ”

Turn off Airplane Mode

Press on the right or left button for 3 seconds to turn it

off. Once Airplane Mode be turned off, meter will start

checking and uploading the test results using Bluetooth

feature.

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Alternative Site Testing

Alternative site testing: palm or forearm blood sampling

- To perform alternative site testing, install the clear cap for your Rightest Lancing Device GD500. ( For detailed information, refer to the instruction manual for the Rightest Lancing Device GD500. )

Palm

Forearm

- To increase the blood flow, massage the intended puncture area of your palm or forearm for a few seconds.

- Immediately after massaging the intended puncture area,

Pressing for a few seconds

Releasing button

press and hold the lancing device with the clear cap against palm or forearm.

- Press the release button.

- Continue holding the lancing device against your palm or forearm and gradually increase pressure for a few seconds until the blood sample size is sufficient. DO NOT test on the palm or forearm if

(

you are testing for hypoglycemia (Low blood glucose).

CAUTION

- Test results may vary if blood samples are taken from different sites or under certain conditions where glucose levels are changing rapidly such as: following a drink, a meal, an insulin dose or exercise. In these cases, only the fingertip should be used.

- DO NOT test on the palm or forearm if you are testing for hypoglycemia (Low blood glucose).

- Fingertip samples can show the rapid change in glucose faster than palm or forearm samples.

- Consult your healthcare professional before sampling from your palm or forearm.

- Since the blood flow in the forearm and palm is slower than in the fingertip, cap provided with the Rightest Lancing Device GD500 when testing

use the clear

sites other than

fingertip.

- If you use the normal lancing device for your palm or forearm, the blood sample may not be sufficient for meter operation.

- Periodically compare the test system to a laboratory test system that is known to be well maintained and monitored by a healthcare provider.

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View Window Appearance Understanding Test Results and Messages

Make sure your blood sample covers the whole area of the view window to get an accurate test result. An insufficient blood sample will result in an error message ("Er4"). If this occurs, repeat the test with a new test strip.

Insufficient blood sample Sufficient blood sample

CAUTION

- Check the expiration date printed on the strip vial every time you use a test strip. Do not use expired Blood Glucose Test Strips GS700.

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- Use each Blood Glucose Test Strip immediately after removing it from the vial.

- Do not reuse Blood Glucose Test Strips . Do not perform testing immediately after moving from one ambient temperature to another

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(e.g. after coming indoors from the outside). Allow 30 minutes for the temperature of the meter and the test strips to equilibrate.

- Apply the blood sample only on the sample port of the test strip.

If your blood glucose result is unusually high or low, or if you question your test results, repeat the test with a new Blood Glucose Test Strip GS700.

You can also run a Quality Control Test with the Control Solutions GC700 to check your

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TM TM

Blood Glucose Meter and Blood Glucose Test Strip GS700 (Refer to

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GM782

“Performing a Quality Control Test” on page 40) .

If the test result still remains unusually high or low, contact your healthcare professional immediately.

If you are experiencing symptoms that are not consistent with your blood glucose test results and you have made sure to follow all instructions in this manual, contact your healthcare professional immediately.

Follow local regulations or consult your health care provider for appropriate disposal of used test strips and lancets.

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Understanding Test Results and Messages About Quality Control Testing

Rightest Blood Glucose

The Meter displays results between 10

GM782

and 600 mg/dL.

If the test result is below 10 mg/dL , “ ” will appear on the screen. Please repeat your test with by a new test strip.

If you still get a “ ” result, contact your healthcare professional.

If the test result is above 600 mg/dL, “ ” will appear on the screen. Please repeat your test again with a new test strip.

If you still get a “ ” result, contact your healthcare professional.

What is a Quality Control Test ? To ensure proper monitoring function, it is necessary to regularly perform a quality control test. Use one of the Control Solutions GC700 when testing your Blood Glucose

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Monitoring System GM782 in the Control Solution Mode. If the test result is within the Control Solution Range printed on the strip vial label, the Blood Glucose Monitoring System GM782 passes the Quality Control Test and your Blood Glucose Monitoring System

TM TM

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GM782 is working properly.

Control Solution Range:

Example of Control Solution Range printed on your test strip vial label.

NOTE

- Normal of Control Solution GC700 is provided in your starter kit. If you want to

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Control Solution Range mg/dL

Low: 28-48

Normal: 107-145 High: 315-426

purchase, High or another Normal control solutions, please contact customer service.

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About Quality Control Testing

When should a Quality Control Test Be Performed ?

- To ensure that your Blood Glucose Meter and Blood Glucose Test GS700

Strip are working properly.

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TM TM

GM782

- To confirm that you are following the correct testing procedures.

- To prepare for your initial blood glucose test.

- To check the Blood Glucose Test Strip when you open a new vial of strips.

To check your Rightest Blood Glucose Meter after it has been dropped, damaged or

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GM782

GS700

exposed to liquids.

- If you suspect that your test results are inaccurate, or if your test results are not consistent with the

way you feel.

- To practice testing.

Required Items for Quality Control Tests To perform a quality control test, prepare the items below :

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- Blood Glucose Meter

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- Blood Glucose Test Strips

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- Control Solution GC700

GM782

GS700

CAUTION

- Each time you open a new bottle of control solution, write the expiration date on the label. The Control Solution GC700 is good for 3 months after opening the bottle, or

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until the expiration date printed on the label, whichever comes first.

Example

Exp. Date 2014-06

- Wipe the bottle cap with a clean tissue before tightly closing the bottle of control solution.

- Close the bottle of control solution tightly immediately after using.

- Check the expiration date before use. (Refer to the Control Solution GC700

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Package Insert).

- Keep control solution bottles out of reach of children.

Page 23

Performing a Quality Control Test

GM782

Performing a Quality Control Test

1. Take one Blood Glucose Test Strip GS700 from the vial

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and close the vial cap immediately.

2. Insert the strip into the test strip port of the Blood

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Glucose Meter GM782 with the view window facing up.

3. While the blood drop icon is flashing on the display window, press and hold the Main button for at least 3 seconds until the " " symbol appears.

4. You will see the blinking " " icon and " " icon on the screen,

prompting you to apply the corresponding level of Control Solution GC700.

5. Shake the bottle of Control Solution GC700 well before opening the cap. Place the cap on a flat surface.

6. Place a drop of control solution onto the top of the cap.

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7. Gently touch the sample port of the strip with the control solution from the top of the cap.

The screen will display the count time starting from 5 (you will hear a beep if the volume is turned on).

9. Tightly replace the cap on the Control Solution GC700 bottle.

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10. The control solution result will appear. Compare your Quality Control Test result to the Control Solution Range printed on the Blood Glucose Test

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Strip GS700 vial label.

OPEN

CAUTION

- Your Control Solution Test results will not be included in the average calculations, however, they can still can be recalled and viewed. The Control Solution Test result will be shown with the " " icon on the screen.

- The Control Solution Test should be conducted between 43-111°F (6-44°C).

- Before " " and " " appear, do not touch the control solution to the sample port on the strip. The Blood Glucose Meter GM782 is performing an internal check.

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Touching the control solution to the sample port before prompted will result in an error message: " " and " " .

- Do not drip the control solution on to the sample port of the test strip directly. The reagent on the strip might leak into the bottle of control solution and may cause the degeneration

of the control solution. This could contaminate the meter via the test strip port.

and be accompanied by beeps (if volume is turned on)

- Keep the test strip port clean and dry. Clean immediately if the test strip port is

stained or is overly exposed to moisture.

- Do not touch the tip of the control solution bottle. If the tip is touched, clean

with water.

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Understanding Control Test Results Recalling Test Results

Your control solution test results should fall within the control solution range printed on the test strip vial label. If the results are within the range, the Blood Glucose Monitoring System

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GM782 is working correctly.

Example of control solution range printed on your test strip vial label

Low

40~60 mg/dL

Possible reasons your Control Solution results are out of the range :

- Your Control solution GC700 is expired or was first opened more than 3 months ago.

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- Your Blood Glucose Test Strip GS700 has expired.

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- You left the cap of the Blood Glucose Test Strip vial or the control solution off for a period of time.

- You did not perform the test procedure correctly.

- The Blood Glucose Meter or Blood Glucose Test Strip GS700 have

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TM TM

GM782

Normal

88~120 mg/dL

High

250~340 mg/dL

malfunctioned.

If Control Solution GC700 results are out of range, your Blood Glucose

Rightest Rightest

Monitoring System GM782 may not be working properly. Repeat the Quality Control Test. If your control solution results are still out of range, do not use Blood Glucose Meter to test your blood glucose. Please contact

TM TM

Rightest

customer service.

GM782

Rightest

The Blood Glucose Meter is able to automatically store a maximum of 500 test

GM782 results with time and date. If your meter has stored 500 results, the newest test result will replace the oldest one.

To recall your test memory, start the meter without a test strip inserted.

1. Press the Main button to switch from the Time Mode to Memory Mode. You

will see the “mem” icon in the upper left corner of the display. The latest test result will appear with the number “1”.

2. Use either the Left or Right button on the side to review all previous results

with date and time. Results display from the most recent (Sequence no. “1”) to the oldest (Sequence no. “500”) in the lower right hand corner of the screen.

3. The Quality Control Test result can be recalled from the saved data. When

" appears next to the data, the test was performed using the

" Rightest

Control Solution GC700. The control solution test result will not be used when recalling test average results.

Page 25

Recalling Average Test Results

The Blood Glucose Meter provides several average test results. View the 1-day,

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7-days, 14-days, 30-days, 60-days and 90-days average test results for better blood glucose monitoring.

1. Press the Main button to switch the screen to Average Mode.

2. On the average screen, use either the Left or Right button to view 1-day, 7-days, 14-days, 30days, 60-days or 90-days averages.

3. The number shown in the lower right hand corner indicates how many test results have been calculated.

4. Excluding test results from the average calculation:

You may exclude the test result from average calculation right after each test. You have to perform this exclusion immediately after the meter displays the reading of your test

result. Press the Right or Left button to choose "NO AVG" then press the main button to confirm. The test result is now excluded from averaging.

GM782

5. Quick Searching: To view test results in sequential order automatically, enter the Memory Mode. Press the Right or

Left button for 2 seconds. (The Right button is for viewing from the most current to the oldest test results. The Left button is for viewing from the oldest to the most current test results). Release the button to stop at any particular test result.

NOTE

The Average function requires that the correct time and date is set.

- Test results must exist during the desired time interval. For example: To get a 14-day average on 1/30/11, you must have test results dated between 1/17 and 1/30. If no test results exist during that time frame you will not receive an average.

- To exclude test results from average calculation, you need to remain in Test Mode and perform the exclusion right after you get the test result. Once you move to MEM Mode, Average Mode or Time Mode, you will not be able to perform the exclusion.

- The "Lo", "Hi" results, control solution test results and test results under abnormal temperature < 43°F (6°C), > 111°F (44°C) will be excluded from average calculations.

Page 26

Caring for Your Meter

Error Messages and Troubleshooting

Maintenance

Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying case when not in use. If your meter is dropped or damaged, perform a quality control test with the control solution before performing a blood glucose test.

Cleaning Meter

Clean the outside of the meter with a damp cloth and mild soap/detergent. Do not get the test strip port wet.

Cleaning Test Strip Port

If your test strip port is stained with blood, control solution or any liquid, please use a dry tissue or alcohol swab to clean it immediately. Do not use anything wet to clean it. Perform a quality control test to ensure the Blood Glucose Meter is working properly.

Rightest

GM782

Temperature Error

1. In order to get accurate testing results, please test between 43-111 °F ( 6-44 °C).

2. When the temperature is below 43 °F (6 °C) or over 111 °F (44 °C), the meter will not function and the " " symbol will blink.

3. If the Blood Glucose Meter and Test Strips are exposed to a

Rightest GM782

substantial change in temperature, please wait 30 minutes before measurement.

Page 27

Error Messages and Troubleshooting

Battery Error

1. The " " and " " symbols appear and the meter will not function when the battery is low. Change the batteries immediately.

Strip Error

1. When the test strip is inserted incorrectly, the meter will beep 4 times while the

2. If, after performing the required steps, the and flashing

Sampling Error

Please do not apply the blood to the sample port of the test strip before the meter displays " ". Discard the test strip If the meter shows " ".

symbol flashes. Do not apply a sample on the test strip. Please re-

" " insert the unused test strip correctly (refer to “Handling the Blood

Rightest

Glucose Test Strip GS700“ on Page 23 for more information).

symbols appear on the screen, it means the Blood Glucose Test

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" " " "

Strip GS700 has been inserted incorrectly more than twice. Please, re-insert the unused test strip again after reviewing the steps on how to insert a test strip correctly on p.23 or call Customer Service for support. This error message can also indicate that you may have used the wrong test strips. Please check the test strip vial to ensure you are using the Blood Glucose Test

Rightest

Strip GS700.

Error Messages and Troubleshooting

Er1 -

The inserted test strip has been used or damaged. Please use a new test strip.

Er2 - The m

Er3 - The s Er4 - The blood sample volume is insufficient.

Er5 - An issue calibrating the Meter has occurred. Please follow the steps below:

If one of the above error messages still appears, please contact Bionime Customer Service.

Meter Malfunction

If the Blood Glucose Meter will not turn on, please follow the steps below:

1. Open the battery cover and remove the batteries.

2. Wait for 5 minutes and reinsert the batteries as described as instructed on page 16, (Meter

The meter should work normally after finishing the above steps. If the meter still does not work, please contact your local customer service.

eter has malfunctioned. Do a Quality Control Test or reinstall the

batteries to check if the meter works properly.

ignal transmission is disrupted. Repeat the test using a new test strip.

strip.

(1) Remove the test strip from the meter. (2) Turn off the meter (press and hold the Main button for 3 seconds). (3) Press the main button to turn ON the meter.

If after turning on the Meter, you do not see Er5, your meter is functioning

properly and able to perform a test.

Rightest GM782

Repeat the test using a new test

Activation and Changing the Battery).

Bionime

Page 28

Error Messages and Troubleshooting

Limitations

CAUTION

A blood sample should ONLY be applied to the test strip after the test strip has been inserted correctly and the Meter's screen is showing the image of the test strip and a blood drop flashing symbol. If the blood drop flashing symbol is NOT showing on the screen, do not apply a sample to the test strip. Please re-insert the unused test strip correctly. The screen MUST show the image of the test strip accompanied by the blood drop symbol flashing (this symbol take 3 seconds to show after correctly inserting the test strip) in order for a sample to be applied. Please consult your User Manual and/or contact Customer Service for support on how to correctly insert a Blood Glucose Test Strip GS700.

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- Blood Glucose Monitoring System GM782 is not intended for serum or plasma testing.

- Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3048 meters) above sea level.

- Severe dehydration and excessive water loss may cause inaccurately low results.

- The glucose test may be invalid in the presence of abnormally high concentration: Ascorbic acid ( 6 mg/dL), Dopamine ( 2.5 mg/dL),

L-Dopa ( 3 mg/dL), .

- Not for screening or diagnosis of diabetes mellitus.

- Not for use on critically ill patients in shock, dehydrated patients or hypo-osmolar patients.

- Alternative site testing (AST) should only be performed during steady-state times (when glucose is not changing rapidly).

- Alternative Site Testing should not be used to calibrate continuous glucose monitoring systems (CGMS). Alternative site testing should not be performed if testing for hypoglycemia (Low blood glucose).

- Results from alternative site testing should not be used in insulin dose calculation.

- Regarding potential electromagnetic or other interference, keep meter out of electromagnetic radiation sources.

≧ ≧

≧ Xylose (≧ 20 mg/dL) and Uric Acid (≧ 20 mg/dL)

Page 29

Specification

Measurement Technology

Sample

Minimum Sample Volume

Measuring Range

Test Time

Memory Capacity

Power Saving

Operating Temperature

Operating Relative Humidity

Dehydrogenase Electrochemical Sensor

Capillary, Venous, Arterial and Neonatal whole blood

0.75 microliters

10 - 600 mg/dL

5 seconds

500 blood glucose test results with date and time

Turns off automatically 2 minutes after last user action. To turn off manually, press the button " " for 3 seconds.

43 - 111°F (6 - 44°C )

10 - 90%

Hematocrit

Power Supply

Battery Life

Meter Dimension

Meter Weight

Monitor

Display Area

Meter Storage/ Transportation Conditions

Test Strip Storage/ Transportation Conditions

10-70%

One CR2032 Battery (3 Voltage)

Approximately 350 standard tests

82 mm x 45 mm x 15.5 mm

43 ± 5g with batteries

LCD

34 mm x 27.5 mm

14 - 140°F ( -10 - 60°C )

( ), < 90% relative humidity 39 - 86°F 4 - 30°C

Page 30

Warranty

Customer Service

Bionime Corporation warrants that this product will be free from defects in materials and workmanship for five years from the date of purchase.

This warranty does not apply to the performance of a Blood Glucose Meter that

Rightest GM782

has been altered, misused, tampered with or abused in any way.

This warranty applies only to the original purchaser of the Blood Glucose Monitoring System .

GM782

Rightest

Please complete and return the enclosed warranty card.

Different models have different specifications. This warranty applies only to the Rightest Blood

Glucose Monitoring System GM782; other models are not covered with this warranty card.

NOTE

- During blood glucose measurement, the Blood Glucose Meter itself may

Rightest GM782 come into contact with blood. All parts of the Blood Glucose Monitoring System GM782 are considered biohazardous and can potentially transmit infectious diseases. Please follow your local regulations to properly dispose of the used Blood

Rightest

Glucose Monitoring System GM782 after removing the batteries.

We sincerely like to provide complete, considerate services to our customers. Please review all the instructions to make sure you are performing the steps correctly. If you have any questions or in case of problems with the products, please contact your local Bionime customer service.

Description of used symbols

For in vitro diagnostic use

IV D

LO T

Lot number

Temperature limitation

EC Representive

Method of sterilization using irradiation

Manufacturer

Expiry date

For single use only

CE-mark (with No. of notified body)

Consult the instruction for use

Caution (consult instructions foruse and warnings)

Page 31

Federal Communications Commission (FCC) StatementExpected Glucose Values Without Diabetes

Expected glucose values without diabetes ⁽¹⁾

Status Fasting Two Hours after meals

Range (mg/dL)

<100 <140

References

1) American Diabetes Association: Standard of Medical Care in Diabetes 2011, Diabetes Care,

Vol.34, supplement 1, S11-S61, January 2011.

Federal Communications Commission (FCC) Statement

15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user's authority to operate the equipment.

15.105(b) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-Reorient or relocate the receiving antenna.

-Increase the separation between the equipment and receiver.

-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

-Consult the dealer or an experienced radio/TV technician for help.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

1) this device may not cause harmful interference and

2) this device must accept any interference received, including interference that may cause undesired operation of the device.

RF Exposure: To comply with the FCC RF exposure compliance requirements, this device and its antenna must not be co-located or operating in conjunction with any other antenna or transmitter.

Page 32

Component Manufacturer Information

Blood Glucose Meter, Test Strip, Control Solution

Manufacturer: Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Product complies with In Vitro Diagnostic Medical Device Directive 98/79/EC. (CE0197) EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck / Switzerland

Lancing Device

Manufacturer: Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Product complies with Medical Device Directive 93/42/EEC EC-Rep:

Disposable Sterile Lancets

Manufacturer: SteriLance Medical (SuZhou) Inc. No.68 LiTangHe RD, XiangCheng, SuZhou, JiangSu 215133, P.R. China Product complies with Medical Device Directive 93/42/EEC. (CE0197) EC- Rep: EMERGO EUROPE, Molenstraat 15, 2513 BH The Hague, The Netherlands

Bionime GmbH, Tramstrasse 16, 9442 Berneck / Switzerland