Bionime rightest gm 100 глюкометр n1 инструкция

Preface

Please read this manual thoroughly before testing. It provides all information you need to use the product. Please only purchase test strips in your country. Use of test strips from different countries might get deviated test results under such circumstance. We hereafter call Rightest^TM GM100 Blood Glucose Monitoring System as GM100 BGMS, Rightest^TM GM100 Blood Glucose Meter as GM100 meter, and Rightest^TM GS100 Blood Glucose Test Strip as GS100 test strip for short. It is recommended to monitor blood glucose regularly. To prevent derived complications effectively, it is recommended to monitor blood glucose regularly. GM100 BGMS accurate and easy-to-use, is your reliable assistant for diabetes management.
GM100 BGMS was manufactured and supported by BionimeCorporation and its authorized representative. If you have any question or concern, please contact your localBionimeCustomerServiceoremailto rightest@bionime.com. We will provide best assistance and solutions for you.

Intended Use

GM100 BGMS is intended for in vitro (oustside the body) diagnostic use and self-testing only. Coding is not required. The testing result is calibrated to plasma equivalent with fresh capillary whole blood samples from the fingertip, palm or forearm. You may consult your healthcare professional for instructions how to use the system correctly. Our customer support staff is also available to assist you.

Package of Meter Kit

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

GS100 Test Strips

GM100 meter is designed to use with GS100 test strip only. Please note that misuse of other test strips might cause unexpected damage or produce inaccurate test results.

Sample Entry
Apply a drop of blood or Control Solution here. The test request is only 1.4 µL of blood.
Hand Bar
Grip here to insert test strip into meter.
View Window
This window is yellow before applying blood sample. It gradually turns red when filled with blood.
Indication Symbol
Insert strip with indication symbol up and toward meter.
Electrode Contacts
Sensing signal output terminals.

PRECAUTION

Battery Installation

Your meter comes with one CR2032, 3 volt, battery installed. One new battery will provide power to perform about 1,000 tests under normal use. Before using it, please pull off the plastic tape and press the main button to activate the meter (If time and date of your meter has been set in advance, the plastic tape will be removed. Hence, please discard this step).

1. Turn the meter over. Press and push battery cover to open.
2. Install the battery. Be sure to put battery in correct direction.
   
3. Slide the battery cover back until it snaps into place.
   
4. The meter performs a self-test and all symbols on the display will blink.
5. Press any button to exit the self-test and enter Setting Mode.
6. Set the time and date when the battery is replaced. See Setting the Date, Time and Unit section. Prior test results are still stored in the memory.

PRECAUTION

Setting Up Your Meter-Setting the Date, Time, and Unit……

You can enter Setting Mode by below two ways.

NOTE

• When you keep pressing the main button for 2 seconds, the display on screen will turn off. Please don’t care it. Keep pressing the main button till entering setting data.
• Quick press the main button allows you to change setting while hold it for 2 seconds will confirm the setting. However, if you press and hold the main button over 5 seconds it will escape from setting mode and return to time screen.

NOTE

Turning on /off the Meter

Performing a Blood Test

1. Hold the adjustable cap in one hand and hold the hub in the other hand. Bend the cap towards the down side. When a gap appears between the cap and hub, pull them off 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 the setting depth matches the window. Settings are based on skin type «» for soft or thin skin; «» for average skin; «» for thick or calloused skin.
   
7. Hold the hub in one hand and pull on the plunger in the other hand. The device will be cocked. Release the plunger, it will automatically move back to its original position near the hub.
   
8. Wash your hands with warm soapy water and dry thoroughly.
   
9. Take one strip from the vial. Re-cap the vial cap immediately.
   
10. Insert the strip into the strip port on meter with the indication symbol facing up.
    
11. While the blood drop symbol flashing, you are ready to apply the blood sample.
    
12. Place the lancing device against the pad of your fingertip and press the release button. The best puncture sites are on the middle or ring fingers. Press the release button.
    
13. Touch and hold the drop to the edge of sample entry until you hear a » beep » and the view window is totally filled with blood. If the view window is not totally filled with blood or the test does not start. Please discard the test strip and repeat the test with a new test strip.
    
    
14. You will see the countdown mode on the screen. After 8 seconds, the test result appears.
    
15. Pull off the depth adjustable cap. Without touching the used disposable lancet, stick the lancet tip into the protective cover.
    
16. Hold the release button in one hand and pull on the plunger in the other hand will safely eject the used disposable lancet.
    
17. Discard the used disposable lancet into an appropriate puncture-proof or biohazard container.
    
18. Replace the depth adjustable cap after finishing the test.
    

PRECAUTION
Do not touch your blood drop to the sample entry on the strip until you see the «» appear. The meter is performing an internal test and will display «» and «» if you apply blood too soon. Then you will waste a test strip.

View window appearance

Make sure your blood sample covers the whole area of the View Window to get an accurate test result. Insufficient blood sample will cause inaccurate test result. Repeat the test with a new test strip.

PRECAUTION

Blood glucose test results are shown on the meter as mg/dL or mmol/L, depending on which unit of measurement you have chosen. ( This meter * for some countries is fixed at mmol/L or mg/dL and is not able to be changed freely.) Consult your healthcare professional before making any changes to your diabetes medication program. If your blood glucose result is unusually high or low, or if you question your testing results, repeat the test with a new test strip. You can also run a Quality Control Test with to check your meter and test strip. 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 of this manual, contact your healthcare professional immediately.

Recalling Test Result & Average

The GM100 meter is able to store 150 test results with time and date automatically. If your meter has stored 150 results, which is the maximum memory of the meter, the newest test result will replace the oldest one.
To recall your test memory, start with the meter without test strip inserted.

1. Press the main button to switch to screen to memory function, you will see «AVG» symbol on the up left corner of the screen. The display sequence will be 1-day, 7-day, 14-day, 30-day, 90- day average, and then memory 1 reading, memory 2 reading,…until memory 150 reading which will show «MEM» on the up right corner of the screen.
2. Under average screen, the number on the down right corner of the screen means how many days of readings have been calculated as the average while the number on the down left corner of the screen means how many readings have been counted in. Under memory screen, it will show the sequence number on the down left corner and then display date and time.
3. Quick Searching: you could also quick press the main button twice, and then it will automatically display the average and memory by sequence. Anytime you want to stop it, you could just press the main button again. It will stop and display the reading right at the moment you press the main button. You could just apply the way above; especially when you find a particular reading you want to check with.
4. Reading right after test: if you just finish the test and press the main button to review. The display sequence will be the latest reading, 1-day, 7-day, 14- day, 30-day, 90-day average, and the memory 2 reading until the oldest one (memory 150 reading).

The GM100 meter displays results between 0.6 and 33.3 mmol/L. If your test result is below 0.6 mmol/L, «» will appear on the screen. Please repeat your test again by a new test strip. If you still get » » result, you should immediately contact your healthcare professional.

If your test result is above the high end of the system’s detection range 33.3 mmol/L, «» will appear on the screen. Please repeat your test again by a new test strip. If you still get «» result, you should immediately contact your healthcare professional.

PRECAUTION

Quality Control Test

Please use Control Solution tested with GM100 BGMS under Control Solution Mode. If the test result is within the Control Solution Range printed on the strip vial label, the GM100 BGMS passes Quality Control Test. That means your GM100 BGMS is working correctly.

Entering Control Solution Mode
Insert the strip into the strip port on meter. While the blood drop symbol flashing, press and hold the main button for over 5 seconds. Then you will see «» symbol blinking on the screen indicating that you’ve successfully entered the Control Solution Mode. Control Solution Range
Control Solution Range

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

When should perform a Quality Control Test?
Before doing a blood glucose test with your meter for the first time.
When you open and start using a new test strip vial.
When your meter is dropped or splashed with liquids.
Whenever you think your test result does not consistent with the way you feel.
Whenever you want to check if your system is working properly or not. Whenever you want to practice testing and check correct procedure.
The possible reasons your Control Solution results are out of the range:

• Your Control Solution has expired or after 3 months since opened.
• Your test strip has expired.
• You leave the cap off the vial of test strips or Control Solution for a long time.
• You didn’t perform the test proce — Malfunction of the meter.

If Control Solution results are out of the range, your GM100 BGMS may not be working properly. Repeat the Quality Control Test. If your Control Solution results outside the range still exist, do not use the GM100 BGMS to test your blood glucose. And contact Bionime authorized representative or Customer Service.

PRECAUTION
Each time you open a new bottle of Control Solution, write the discard date on the label. Control Solution is good for 3 months after opening the bottle, or until the expiration date printed on the label, whichever comes first.

Performing a Quality Control Test

Use with Control Solution

PRECAUTION

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 meter is dropped or damaged, perform a Quality Control Test before doing a blood glucose test.

Cleaning Meter
Clean the outside of the meter with a damp cloth and mild soap/detergent. Keep the test strip port from getting wet.

Error Message and Trouble Shooting

Battery Error

Temperature Error
In order to get accurate test result, perform testing between 10 ~40 ˚C (50 ~ 104 ˚F).

Sampling Error
Before «» appears. Please don’t apply the blood to the entry of the strip because the meter is still doing internal check. If you do so, the meter will show «» and ««. Please remove the test strip and insert a new one to do the test again.

Meter Malfunction
If you find the meter can’t be switched on, please follow the steps below for quick inspection.

The meter should be work normally after finishing above steps. If not, please contact Bionime authorized representative or Customer Service.

Specification

Measurement Technology	Oxidase Electrochemical Sensor
Sample	Capillary whole blood
Minimum Sample Volume	1.4 microliters ( µL )
Measuring Range	0.6 — 33.3 mmol/L
Test Time	8 seconds
Memory Capacity	150 blood glucose test results with date and time
Power Saving	Turn off automatically after 2 minutes no use. Or press the «» button for 2 seconds.
Operating Temperature	10 ~ 40 ˚C (50 ~ 104 ˚F)
Operating Relative Humidity	10 — 90 %
Hematocrit	35 — 48 %
Power Supply	One CR2032 battery
Battery Life	About 1,000 tests
Meter Dimension	95.0 mm x 43.8 mm x 13.0 mm
Meter Weight	43.0 g with batteries
Monitor Display Area	LCD display 38.0 mm x 29.0 mm
Meter Storage Conditions	-10 ~ 60 ˚C (14 ~ 140 ˚F)
Test Strip Storage Conditions	4~30 ˚C(39~86 ˚F), < 90% relative humidity

Limitations

Customer Service
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 problems of Rightest^TM GM100 products, please contact your local Bionime distributor. Or email to rightest@bionime.com.

Warranty
Bionime Corporation warrants that your GM100 Meter 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 GM100 Meter that has been altered, misused, tampered with or abused in any way.
This warranty applies only to the original purchaser of the meter. Please complete and return the enclosed warranty card to Bionime authorized representative.
Different models have different specifications. Some of the models are not included with the warranty card.

Parts of Critical Component
Blood Glucose Meter, Test Strip, Control Solution and Lancing Device
Manufacturer: Bionime Corp.
Product complied with In Vitro Diagnostic Medical Device Directive 98/79/EC.
(CE 0197)
EU Rep: BIONIME GmbH; Tramstrasse 16, 9442 Berneck, Switzerland E-mail: info@bionime.ch

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

BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 23692388
Fax: +886 4 22617586
E-mail: info@bionime.com
http://www.bionime.com

Bionime GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: info@bionime.ch

Accompanying Data:

BIONIME Rightest GM100 Blood Glucose Meter PDF Instructions For Use (Updated: Friday 30th of June 2023 07:25:48 AM)

Rating: 4.7 (rated by 53 users)

Compatible devices: Rightest GM782, GM232B, Rightest GS260, Rightest GT100, rightest GM260, Rightest GM700, Rightest ALPHA, RIGHTEST HR310.

Recommended Documentation:

Manual, Instructions For Use (Text Version):

(Ocr-Read Summary of Contents of some pages of the BIONIME Rightest GM100 Document (Main Content), UPD: 30 June 2023)

• BIONIME Rightest GM100 User Manual

• BIONIME Rightest GM100 User Guide

• BIONIME Rightest GM100 PDF Manual

• BIONIME Rightest GM100 Owner’s Manuals

Recommended: HDT-1X, T1006, ENP100, D-7

Links & Tools

Operating Impressions, Questions and Answers:

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9.

View window appearance

Make sure your blood sample covers the whole area of the View Window to get

an accurate test result. Insufficient blood sample will cause inaccurate test

result. Repeat the test with a new test strip.

Insufficient blood sample

Enough blood sample

PRECAUTION

— Check the expiration date printed on the package every time you use a

strip. Do not use expired test strips.

— Use each test strip immediately after removing from the vial.

— Do not reuse test strips.

— Do the test at least 30 minutes after moving into a different location with

significant change in temperature.

— Place the blood drop only on the sample entry of the strip.

— Please don’t drip or inject the blood sample directly by

syringe to the entry port of test strip. Doing this might

contaminate the meter or cause damage and is strongly

not recommended.

Blood glucose test results are shown on the meter as

mg/dL

or

mmol/L

depending on which unit of measurement you have chosen. Consult your

healthcare professional before making any changes to your diabetes

medication program.

If your blood glucose result is unusually high or low, or if you question your

testing results, repeat the test with a new test strip. You can also run a Quality

Control Test with

Control Solutions to check your meter and strip. 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 of this

manual, contact your healthcare professional immediately.

The

Meter displays results between 10 and 600 mg/dL

( 0.6 and 33.3 mmol/L). If your test result is below 10 mg/dL ( 0.6

mmol/L ), «

» will appear on the screen. Please repeat your test

again by a new strip. If you still get «

» result, you should

immediately contact your healthcare professional.

If your test result is above the high end of the system’s detection

range 600 mg/dL ( 33.3 mmol/L ), «

» will appear on the screen.

Please repeat your test again by a new strip. If you still get «

«

result, you should immediately contact your healthcare

professional.

10.

Recalling Test Result & Average

The

meter is able to store 10 test results with time and date

automatically. If your meter has stored 10 results, which is the maximum

memory of the meter, the newest test result will replace the oldest one.

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

1. Press the main button to switch the screen to memory function, you will see

» mem » symbol on the up right corner of the screen. it will show the latest

testing result with time and date. The latest result is with sequence number,

» 1″.

2. Under the memory screen, use main button to review all previous results with

date and time. You will see results from the most recent ( Sequence no, » 1 » )

to the oldest ( Sequence no, » 10 » ) on the down left corner of the screen.

3. The

meter provides you several average test results. You can

view 1-day, 7-day 14-day or 30-day average of test results depending on

which one you’ve chosen in setting mode for better blood monitoring of your

blood glucose.

4. Press the main button until the «AVG» symbol appears on the up left corner of

the screen. The you will see 1-day, 7-day, 14-day or 30-day average of test

results depending on which one you’ve chosen in setting mode.

5. The number shown on the down left corner means how many test results are

calculated.

6. The «

» , «

» results, the control solution results, the non — average test

results and the test result made out of normal temperature range

( <10℃, >40℃ ) are not calculated in the average.

PRECAUTION

— You have to set the time and date to activate the average function.

11.

Quality Control Test

To make sure that your blood glucose monitoring system works properly, you

must perform quality control testing.

1. Entering Control Solution mode

Insert the strip into the strip port on meter. While the blood drop symbol

flashing, press and hold the main button for over 5 seconds. Then you will

see «

» symbol blinking on the screen indicating that you’ve successfully

entered the control solution mode.

2. Control Solution Test

A control solution test ensures that the meter and test strips are functioning

properly together. Once you enter control solution mode, you are ready to

perform a control solution test.

When should perform a quality control test ?

Before doing a blood glucose test with your meter for the first time.

When you open and start using a new test strip vial.

When your meter is dropped or splashed with liquids.

Whenever you think your test result does not consistent with the way you feel.

Whenever you want to check if your system is working properly or not.

Whenever you want to practice testing and check correct procedure.

PRECAUTION

Each time you open a new bottle of

Control solution, write the discard date

on the label. Control solution is good

,

for 3 months after opening the bottle,

or until the expiration date printed on

the label, whichever comes first.

Understanding Control Test Results

Your control solution test results should fall within the control solution range.

That means your

System is working correctly.

Control Solution Range

Example of control solution range printed

79-107 mg/dL

on your test strip vial label.

4.4-5.9 mmol/L

If control solution test results are out of control solution range, your

System may not be working properly. Repeat the quality control test. If your

control solution results outside the range still exist, do not use the

System to test your blood glucose. And contact Bionime authorized distributor

or Bionime Customer Service.

The reason your control solution results are out of the range :

— our control solution has expired or after 3 months since opened.

Y

— Your test strip has expired.

— You leave the cap off the vial of test strips or control solution for a long time.

— You didn’t perform the test proce

dure correctly.

—

Malfunction of the meter.

12.

Performing a Quality Control Test

Use with Control Solution

1. Take one test strip from vial and Re-cap the vial

cap immediately.

2. Insert the test strip with view window, facing up,

into test strip port.

3. While the blood drop symbol flashing, press and hold the main button for

over 5 seconds until the «

» symbol appears.

4. You will see blinking «

» symbol and «

«

symbol on the screen prompting you to apply

control solution.

5. Shake the bottle of control solution well before

opening the cap. Then open the cap and put it

on the table.

6. Drip a drop of control solution on the top of the

cap.

7. Gently touch sample entry of the strip with the

control solution on the top of the cap.

8. When you hear a beep, leave the meter on the

table while waiting for the test result.

The screen will display the countdown.

9. Tightly replace the cap on the control solution

bottle.

10. The control solution result appears. Compare your control test result to the

range printed on the test strip vial label.

PRECAUTION

— Your quality control test result by control solution test will not be

calculated for average reading but still can be recalled. The control

solution test result will be shown with «

» symbol on the screen.

— Before «

» and «

» appears, please don’t touch the control solution

to the sample entry on strip because the meter is still in an internal

check. If you do so, the meter will show «

— Don’t drip the control solution to sample entry of the strip directly. The

reagent on strip might be sucked into the bottle of control

solution and might cause the degeneration of control

solution. Doing this might contaminate the meter via the

test strip port as well.

— Don’t touch the control solution. If you have touched it,

please clean up with water.

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 meter is dropped or damaged,

perform a quality control test with control solution before doing a blood glucose

test.

Cleaning Meter

Clean the outside of the meter with a damp cloth and mild soap/detergent.

Keep the test strip port from getting wet.

13.

Error Message and Trouble Shooting

Er1 — The inserted strip has been used or

damaged. Please use a new test strip from

Exp. Date 2008-01

vial.

Er2 — Meter has malfunctioned. Do the quality

control test or reinstall the battery to see

if the meter works properly. If error screen still appears,

contact Bionime Customer Service.

Er3 — Signal transmission is disrupted, repeat the test.

Battery Error

1. The «

» symbol is blinking when the battery

power is low. Please change battery as soon

as you can. You can still do the test.

2. The «

» and «

» symbols are blinking

when the battery is too low. Meter can not do

the strip test. Please change the battery

immediately.

3. After changing the battery, perform a quality control test.

Temperature Error

In order to get accurate test result,

perform

( 50~104℉ ).

1. When the ambient temperature is 0~9℃ ( 32~48℉) or

41~50℃ (106~122℉) the «

» warning symbol will be

blinking, you still can do the test but the test result is only for

reference because the test result under these ranges of

temperature might not be correct. Repeat the test at an area

with temperature between operating range. ( 10~40℃ or

50~104℉ )

2. When you move from the area with temperature outside the

operating range of test strip to another area with temperature

inside operating range of test strip, please wait for 30 minutes

before you do the test.

3. When the temperature is below 0℃ ( 32℉ ) or over 50℃

OPEN

( 122℉ ), Meter can not do the test and the «

blink in this condition. Please move the meter to environment

with temperature between 10~40℃ ( 50~104℉ ) and repeat

the test after 30 minutes.

Sampling Error

Before «

» appears. Please don’t apply the blood to the entry of

the strip because the meter is still doing internal check. If you do

so, the meter will show «

» and «

strip and insert a new one to do the test again.

Meter Malfunction

If you find the meter can’t be switched on, please follow the steps below for

CLOSE

quick inspection.

1. Open the battery cover, take out the battery.

2. Wait for 5 minutes and reload the new battery.

The meter should be work normally after finishing above steps. If not, please

contact Bionime authorized distributor or Customer Service Center.

Specification

Measurement Technology

Oxidase Electrochemical Sensor

Sample

Capillary

Minimum Sample Volume

1.4 microliter

Measuring Range

Test Time

» and «

«.

Memory Capacity

Power Saving

Operating Temperature

Operating Relative Humidity

Hematocrit

Power Supply

Battery Life

Meter Dimension

Meter Weight

Monitor

Display Area

Meter Storage Conditions

Test Strip Storage Conditions

Limitations

—

Blood Glucose Test strips are designed for using with capillary

whole blood samples. Do not use serum or plasma samples.

— Inaccurate test results may be obtained at high altitude more than about

10,000 feet ( 3048 meters ) above sea level.

— Severe dehydration and excessive water loss may cause inaccurately low

results.

—

Blood Glucose Monitoring has not been validated for use on

neonates.

— The glucose test may be interfered under abnormal concentration of

Uric acid > 9.0 mg/dL ( > 0.54 mmol/L )

Cholesterol > 500 mg/dL ( > 13 mmol/L )

Customer Service

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. You are always welcome to contact us by call: 886 4 24951268

( GMT+08:00, 08:30~17:30 ), or by e-mail at info@bionime.com If you have

testing between

10~40℃

any question or advice.

Warranty

Bionime Corporation warrants that your

materials and workmanship for five years from the date of purchase.

This warranty does not apply to the performance of a

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

This warranty applies only to the original purchaser of the meter.

Please complete and return the enclosed warranty card to Bionime authorized

representative.

Different models have different specifications. Some of the models are not included with

the warranty card.

Parts of Critical Component

Blood Glucose Meter, Test Strip, Control Solution and Lancing Device

Manufacturer: Bionime Corp.

Product complied with In Vitro Diagnostic Medical Device Directive 98/79/EC. ( CE0197 )

» symbol will

EU Rep: BIONIME GmbH; Heinrich Wild Strasse 202, CH-9435 Heerbrugg / Switzerland

Disposable Sterile Lancets

Manufacturer: Vitrex Medical ApS.

Product complied with Medical Device Directive 93/42/EEC. ( CE0459 )

IVD

For in vitro diagnostic use

Use by

«. Please remove the

Method of sterilization using irradiation

BIONIME CORPORATION

whole blood

694, Renhua Road, Dali City,

Taichung County, Taiwan 412

Tel: +886 4 24951268

E-mail: info@bionime.com http://www.bionime.com

10-600 mg/dL ( 0.6-33.3 mmol/L )

8 seconds

10 blood glucose test results with date

and time

Turn off automatically after 2 minutes no

use Press the «

» button for 2 seconds.

10 ~ 40℃ ( 50 ~ 104℉ )

10 — 90%

30 — 55%

one CR2032 battery

About 1000 tests

95.0 mm x 43.8 mm x 13.0 mm

43.0 g with batteries

LCD display

39.0 mm x 38.0 mm

-10 ~ 60℃ ( 14 ~ 140℉ )

4 ~ 30℃ ( 39 ~ 86℉ ),< 90% relative

humidity

Meter will be free from defects in

Meter that has been

LOT

Lot number

Manufacturer

Temperature limitation

Do not reuse

EU Representative:

BIONIME GmbH

Heinrich Wild Strasse 202,

Fax: +886 4 24952568

CH-9435 Heerbrugg

Switzerland

101-1GM100-010

4. Time format 12/24H selection

With the time format blinking, press the main

button to adjust it. Then hold the same button

for 2 seconds to confirm it and move to hours

setting.

5. Hour setting

With the hour blinking, press the main button until the current

hour appears. Then hold the same button for 2 seconds to

confirm it and move to minute setting.

6. Minute setting

With the minute blinking, press the main button

to adjust it. Then hold the same button for 2

seconds to confirm it. Meantime, it will shift to

next digit for setting. Repeat the above action

until the minute setting is completed. Then it will

move to average-day setting.

7. Average-day setting

With the number » 1, 7, 14, 30 » blinking, press

the main button for the days of the average you

would like to read. Then hold the same button

for 2 seconds to confirm it and move to

measurement unit setting.

8. Setting the unit of measurement

With milligrams per deciliter (mg/dL) or

minimole per liter (mmol/L) blinking, press the

9. Ending setting

After confirm the measurement unit, you’ll hear a sound of » beep «. All the

settings are saved and completed and will return to time screen.

1. Year setting

With the year format blinking, press the main button to adjust

it. Then hold the same button for 2 seconds to confirm it.

Meantime, it will shift to next digit for setting. Repeat the above

action until the year setting is completed. Then it will move to

month setting.

2. Month setting

With the month blinking, press the main button until the

current month appears. Then hold the same button for 2

seconds to confirm it and move to day setting.

3. Day setting

With the day blinking, press the main button to adjust it. Then

hold the same button for 2 seconds to confirm it. Meantime, it

will shift to next digit for setting. Repeat the above action until

the day setting is completed. Then it will move to time format

setting.

NOTE

— When you do not do any settings of meter for over 2 minutes, the meter

will leave setting mode and power off automatically.

— Any time you would like to escape from the setting mode, please press

and hold the main button for over 5 seconds. Meantime, all the current

settings will be saved.

main button to switch. Then hold the same button for 2 seconds to confirm it.

PRECAUTION

— Re-cap the test strip the vial immediately after removing a test strip.

— Do not reuse test strips.

— Do not use expired test strips.

— Record the date of opening a new strip vial for the first time. Discard the

vial of strips after 3 month from opening.

— Store the test strips in a cool and dry location. Do not expose to direct

sunlight or heat.

— For detailed information, please refer to the GS100 Test Strip

Package Insert.

Intended Use

Blood Glucose Monitoring System

Instructions for Use

The Blood Glucose Monitoring System is intended for in vitro

diagnostic use ( for self-testing ) only ( outside the body ) and coding is not

required. The testing result is calibrated to be plasma equivalent for test with

fresh capillary whole blood samples from the fingertip, palm or forearm

depends on what kind of lancing device you are using. 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.

1.

Package of Meter Kit2.

Preface

3 ＊2 ＊1

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

include ＊ items.)

The Meter3.

Precautions4.

— Before using the System to test your blood glucose, please read

all the instructions and practice the tests including quality control test.

— Please do the quality control test regularly to make sure the test results are

accurate .

— The GM100 Blood Glucose Meter can only be used with the

GS100 Blood Glucose Test strips. The use of any other brand

strips should not be used under any circumstances. The use of other brands

of strips may produce inaccurate results.

— The Blood Glucose Monitoring System is intended for self-testing. It

should not be used to diagnose diabetes mellitus.

— Blood Glucose Monitoring System has not been validated for use

on neonates. Therefore, it’s not intended for use of neonates.

— This meter can be only tested with capillary whole blood. Please don’t test with

arterial blood.

— Do the test at least 30 minutes after moving into a different location with

significant change in temperature.

— Dispose of used batteries properly.

— Please note the meter kit contains small parts like test strips which could result

in a choking hazard for children.

— Prevent water from entering the meter. Never immerse the meter or hold it

under running water.

— The minimum blood sample size for testing is 1.4µl )

Sample Size Example

1.0 1.4 2.0 3.0µl µl µl µl 4 µl .0

The Test Strip ( GS100 Test Strip )5.

Sample Entry

µl

Apply a drop of blood or control solution

here. The test request is only 1.4 of blood.

Electrode Contacts

Sensing signal output terminals.

Noble Metal Electrodes

Electrochemical sensor

Indication Symbol

Insert strip with indication symbol

up and toward meter.

Battery Installation6.

10. While the blood drop symbol flashing, you are ready to apply the blood

sample.

11. Place the lancing device against the pad of

your fingertip and press the release button.

The best puncture sites are on the middle or

ring fingers. Press the release button.

14. Pull off the depth adjustable cap. Without touching the used disposable

lancet, stick the lancet tip into the protective cover.

15. Hold the release button in one hand and pull on the plunger in the other

hand will safely eject the used disposable lancet.

16. Discard the used disposable lancet into an appropriate puncture-proof or

biohazard container.

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

12. Touch and hold the drop to the edge of

sample entry until you hear a » beep » and the

view window is totally filled with blood. If the

view window is not totally filled with blood or

the test does not start. Please discard the test

strip and repeat the test with a new test strip.

13. You will see the countdown mode on the

screen. After 8 seconds, the test result

appears.

1

2

The Blood Glucose Monitoring System was manufactured by

supported by Bionime Corporation and its authorized representative. If you

have any questions or concerns, please contact your Bionime authorized

representative or call us by phone number, 886 4 24951268 ( GMT+08:00,

08:30~17:30 ). We will provide best assistance and solutions for you.

Hand Bar

Grip here to insert

test strip into meter.

View Window

This window is yellow before applying

blood sample. It gradually turns red

when filled with blood.

We suggest you use a sample between 1.4~2.5µl. A blood sample size above

4.0µl is too large. A blood sample size below 1.4µl may give an inaccurate test

result. In this case, repeat the test with a new test strip.

GM100 is designed to use with GS100 strip only. Please note that

misuse of other strips might cause unexpected damage or produce

inaccurate test results.

Thank you for selecting the Blood Glucose Monitoring System.

Please read this manual thoroughly before you start testing. It provides all the

information you need to use the product. You will get a correct test result by the

following instruction of this manual. Please only purchase the test strips in

your country, the use of the test strips of different countries is not

suggested and might get deviated test results under such circumstance.

It is quite important for you to monitor blood glucose regularly. A derived

complication can thus be effectively reduced. Through the assistance of

Blood Glucose Monitoring system, which provides considerate

design and accurate results, your diabetes management can become more

reliable and ease-to-use.

Display Window

Show your test result,

messages and relative

information.

Test Strip Port

Insert test strip here until you

hear a click.

Main Button

Press to turn on/off meter.

Switch different function

screen.

Press and hold down until

enter to the setting mode.

(There will be a power-off

period during this process.)

Battery Cover

Slide cover to

change battery.

Meter Serial

Number

Model Number

Plastic Tape

Pull it off to activate meter.

Test Str ips

20

07—

06

1. Meter

2. Test Strips (0/10/25 pcs) *

3. Control Solutions *

4. Instructions for Use

5. Blood Glucose Test Strip

Package Insert *

6. Lancing Device *

7. Disposable Sterile Lancets

(10pcs) *

8. Instruction for the lancing device *

9. Log Book

10. Warranty Card + Emergency

11. CR2032 Battery (Inserted into the

meter)

12. Carrying Case *

7 ＊

8 ＊

6 ＊

4

5 ＊

9. Insert the strip into the strip port on meter with the indication symbol facing

up.

1110

13

1614 15 17

Setting Up Your Meter-Setting the Date, Time, and Unit ……

7.

PRECAUTION

— Danger of explosion might happen if the battery is incorrectly replaced.

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

6. Set the time and date when the batteries are replaced. See Setting the Date,

Time and Unit section. Prior test results are still stored in the memory.

Your meter comes with one CR2032, 3volt, battery installed. One

new battery will provide power to perform about 1000 tests under

normal use. Before using it, please pull off the plastic tape and

press the main button to activate the meter. The low battery

symbol » » will keep appearing on your display if your battery

runs low. Please keep spares on hand and replace the battery

soon when a battery symbol appears.

1. Turn the meter over. Press and push battery

cover to open.

2. Install the battery. Be sure to put battery in

correct direction.

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

4. The meter performs a self-test and all symbols on the display

will blink.

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

5. Choose a depth of penetration by rotating the

top portion of the depth adjustable cap until

the setting depth matches the window.

Settings are based on skin type » » for soft

or thin skin; » » for average skin; » » for

thick or calloused skin.

1. Pull off the depth adjustable cap.

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

3. Twist off and set aside the protective cover of the disposable lancet.

4. Replace the depth adjustable cap.

6. Hold the hub in one hand and pull on the plunger in the other hand. The

device will be cocked. Release the plunger, it will automatically move back to

its original position near the hub.

1 2 3 4

5

6

7. Wash your hands with warm

soapy water and dry thoroughly.

8. Take one strip from the vial. Re-

cap the vial cap immediately.

7 8 9

Performing a Blood Test

8.

Hub

Lancet carrier

Plunger

Release button

Depth adjustable cap

You can enter Setting Mode by below two ways.

1. Reload battery

After removing the battery, please press the main button for several times

until no signal on screen, then follow the battery installation steps to load

battery. The meter will do self test. Press the main button to close the test

and enter Setting Mode.

2. With Battery inserted

Press the main button first to turn on the meter. Then press and hold the main

button for 5 seconds (the meter will be turned off during this period, please

keep pressing) until you hear a beep, indicating you have successfully

entered Setting Mode. The display screen will show setting data.

NOTE

— When you keep pressing the main button for 2 seconds, the display on

screen will turn off. Please don’t care it. Keep pressing the main button

till entering setting data.

— Quick press the main button allows you to change setting while hold it

for 2 seconds will confirm the setting. However, if you press and hold

the main button over 5 seconds it will escape from setting mode and

return to time screen.

Turning on /off the Meter

1. Auto Power off

The meter will power off automatically if you don’t operate it over 2 minutes.

2. Manual Power off

If you want to turn off the meter, please keep pressing the main button for 2

seconds.

3. How to turn on the Power

1) Press the main button

2) Insert one piece of test strip

PRECAUTION

Do not touch your blood drop to the sample entry on the strip until you

see the » » appear. The meter is performing an internal test and will

display » » and » » if you apply blood too soon. Then you will waste

a test strip.

12