4. Precautions 6. Set the time and date when the batteries are replaced.

6. Set the time and date when the batteries are replaced. See Setting the Date, Turning on /off the Meter
Time and Unit section. Prior test results are still stored in the memory. 1. Auto Power off
- Before using the System to test your blood glucose, please read The meter will power off automatically if you don't operate it over 2 minutes.
all the instructions and practice the tests including quality control test. PRECAUTION 2. Manual Power off
Blood Glucose Monitoring System - Please do the quality control test regularly to make sure the test results are - Danger of explosion might happen if the battery is incorrectly replaced. If you want to turn off the meter, please keep pressing the main button for 2
- Please follow the local regulation and discard a used battery properly.
Instructions for Use accurate .
- The GM100 Blood Glucose Meter can only be used with the
seconds.
3. How to turn on the Power
GS100 Blood Glucose Test strips. The use of any other brand 7. Setting Up Your Meter-Setting the Date, Time, and Unit
1) Press the main button
strips should not be used under any circumstances. The use of other brands You can enter Setting Mode by below two ways. 2) Insert one piece of test strip
Preface of strips may produce inaccurate results. 1. Reload battery
- The Blood Glucose Monitoring System is intended for self-testing. It After removing the battery, please press the main button for several times 8. Performing a Blood Test
Thank you for selecting the Blood Glucose Monitoring System.
should not be used to diagnose diabetes mellitus. until no signal on screen, then follow the battery installation steps to load
Please read this manual thoroughly before you start testing. It provides all the Depth adjustable cap
- Blood Glucose Monitoring System has not been validated for use battery. The meter will do self test. Press the main button to close the test Release button
information you need to use the product. You will get a correct test result by the
on neonates. Therefore, it's not intended for use of neonates. and enter Setting Mode.
following instruction of this manual. Please only purchase the test strips in
- This meter can be only tested with capillary whole blood. Please don't test with 2. With Battery inserted Plunger
your country, the use of the test strips of different countries is not
arterial blood. Press the main button first to turn on the meter. Then press and hold the main
suggested and might get deviated test results under such circumstance. Lancet carrier Hub
- Do the test at least 30 minutes after moving into a different location with button for 5 seconds (the meter will be turned off during this period, please
It is quite important for you to monitor blood glucose regularly. A derived
significant change in temperature. keep pressing) until you hear a beep, indicating you have successfully 1. Pull off the depth adjustable cap.
complication can thus be effectively reduced. Through the assistance of
- Dispose of used batteries properly. entered Setting Mode. The display screen will show setting data. 2. Insert a new disposable lancet firmly into lancet carrier.
Blood Glucose Monitoring system, which provides considerate
- Please note the meter kit contains small parts like test strips which could result 3. Twist off and set aside the protective cover of the disposable lancet.
design and accurate results, your diabetes management can become more NOTE
in a choking hazard for children. 4. Replace the depth adjustable cap.
reliable and ease-to-use. - When you keep pressing the main button for 2 seconds, the display on
- Prevent water from entering the meter. Never immerse the meter or hold it
The Blood Glucose Monitoring System was manufactured by screen will turn off. Please don't care it. Keep pressing the main button 1 2 3 4
under running water.
supported by Bionime Corporation and its authorized representative. If you - The minimum blood sample size for testing is 1.4l :( ) till entering setting data.
have any questions or concerns, please contact your Bionime authorized - Quick press the main button allows you to change setting while hold it
representative or call us by phone number, 886 4 24951268 ( GMT+08:00, 1.0l 1.4l 2.0l 3.0l 4.0l for 2 seconds will confirm the setting. However, if you press and hold
Sample Size Example
08:30~17:30 ). We will provide best assistance and solutions for you. the main button over 5 seconds it will escape from setting mode and
return to time screen. 5. Choose a depth of penetration by rotating the 5
1. Intended Use We suggest you use a sample between 1.4~2.5l. A blood sample size above 6
4.0l is too large. A blood sample size below 1.4l may give an inaccurate test 1. Year setting top portion of the depth adjustable cap until
The Blood Glucose Monitoring System is intended for in vitro result. In this case, repeat the test with a new test strip. With the year format blinking, press the main button to adjust the setting depth matches the window.
diagnostic use ( for self-testing ) only ( outside the body ) and coding is not it. Then hold the same button for 2 seconds to confirm it. Settings are based on skin type " " for soft
required. The testing result is calibrated to be plasma equivalent for test with 5. The Test Strip ( GS100 Test Strip ) Meantime, it will shift to next digit for setting. Repeat the above or thin skin; " " for average skin; " " for
fresh capillary whole blood samples from the fingertip, palm or forearm action until the year setting is completed. Then it will move to thick or calloused skin.
depends on what kind of lancing device you are using. You may consult your GM100 is designed to use with GS100 strip only. Please note that
month setting. 6. Hold the hub in one hand and pull on the plunger in the other hand. The
healthcare professional for instructions on how to use the system correctly. Our misuse of other strips might cause unexpected damage or produce
2. Month setting device will be cocked. Release the plunger, it will automatically move back to
customer support staff is available to assist you as well. inaccurate test results.
With the month blinking, press the main button until the its original position near the hub.
Sample Entry current month appears. Then hold the same button for 2
Noble Metal Electrodes 7 8 9
2. Package of Meter Kit Apply a drop of blood or control solution seconds to confirm it and move to day setting. 7. Wash your hands with warm
Electrochemical sensor here. The test request is only 1.4l of blood. soapy water and dry thoroughly.
1. Meter 7. Disposable Sterile Lancets 3. Day setting
8. Take one strip from the vial. Re-
2. Test Strips (0/10/25 pcs) * (10pcs) * With the day blinking, press the main button to adjust it. Then
cap the vial cap immediately.
3. Control Solutions * 8. Instruction for the lancing device * Hand Bar hold the same button for 2 seconds to confirm it. Meantime, it
9. Log Book Grip here to insert will shift to next digit for setting. Repeat the above action until 9. Insert the strip into the strip port on meter with the indication symbol facing
4. Instructions for Use
10. Warranty Card + Emergency test strip into meter. the day setting is completed. Then it will move to time format up.
5. Blood Glucose Test Strip
11. CR2032 Battery (Inserted into the setting.
Package Insert * Indication Symbol View Window 10. While the blood drop symbol flashing, you are ready to apply the blood
meter) 4. Time format 12/24H selection
6. Lancing Device * Insert strip with indication symbol This window is yellow before applying sample.
12. Carrying Case * With the time format blinking, press the main
up and toward meter. blood sample. It gradually turns red button to adjust it. Then hold the same button 10 11
( Different packages have different bundled items. Some of packages might not when filled with blood. 11. Place the lancing device against the pad of
include items.) for 2 seconds to confirm it and move to hours
your fingertip and press the release button.
setting.
The best puncture sites are on the middle or
1 2 3 4 Electrode Contacts ring fingers. Press the release button.
5. Hour setting
Sensing signal output terminals. With the hour blinking, press the main button until the current 12
Test Strips
12. Touch and hold the drop to the edge of
hour appears. Then hold the same button for 2 seconds to sample entry until you hear a " beep " and the
5 PRECAUTION confirm it and move to minute setting. view window is totally filled with blood. If the
- Re-cap the test strip the vial immediately after removing a test strip.
2007-06

6. Minute setting view window is not totally filled with blood or

- Do not reuse test strips.
With the minute blinking, press the main button the test does not start. Please discard the test
- Do not use expired test strips.
6 7 8 to adjust it. Then hold the same button for 2 strip and repeat the test with a new test strip. 13
- Record the date of opening a new strip vial for the first time. Discard the
vial of strips after 3 month from opening. seconds to confirm it. Meantime, it will shift to
next digit for setting. Repeat the above action 13. You will see the countdown mode on the
- Store the test strips in a cool and dry location. Do not expose to direct
until the minute setting is completed. Then it will screen. After 8 seconds, the test result
sunlight or heat.
move to average-day setting. appears.
- For detailed information, please refer to the GS100 Test Strip
Package Insert. 7. Average-day setting
14. Pull off the depth adjustable cap. Without touching the used disposable
With the number " 1, 7, 14, 30 " blinking, press
3. The Meter lancet, stick the lancet tip into the protective cover.
6. Battery Installation the main button for the days of the average you
15. Hold the release button in one hand and pull on the plunger in the other
would like to read. Then hold the same button
Test Strip Port Your meter comes with one CR2032, 3volt, battery installed. One for 2 seconds to confirm it and move to hand will safely eject the used disposable lancet.
Insert test strip here until you 16. Discard the used disposable lancet into an appropriate puncture-proof or
hear a click. new battery will provide power to perform about 1000 tests under measurement unit setting.
normal use. Before using it, please pull off the plastic tape and 8. Setting the unit of measurement biohazard container.
press the main button to activate the meter. The low battery With milligrams per deciliter (mg/dL) or 17. Replace the depth adjustable cap after finishing the test.
Display Window symbol " " will keep appearing on your display if your battery minimole per liter (mmol/L) blinking, press the 14 15 16 17
Show your test result, runs low. Please keep spares on hand and replace the battery main button to switch. Then hold the same button for 2 seconds to confirm it. 1
2
messages and relative Model Number soon when a battery symbol appears.
information. 9. Ending setting
Meter Serial
101-1GM100-010

1. Turn the meter over. Press and push battery After confirm the measurement unit, you'll hear a sound of " beep ". All the
Number
cover to open. settings are saved and completed and will return to time screen.
Main Button 2. Install the battery. Be sure to put battery in
correct direction. NOTE
Press to turn on/off meter.
Battery Cover - When you do not do any settings of meter for over 2 minutes, the meter PRECAUTION
Switch different function
Slide cover to 3. Slide the battery cover back until it snaps into place.
screen.
change battery.
will leave setting mode and power off automatically. Do not touch your blood drop to the sample entry on the strip until you
Press and hold down until 4. The meter performs a self-test and all symbols on the display - Any time you would like to escape from the setting mode, please press see the " " appear. The meter is performing an internal test and will
enter to the setting mode. will blink.
(There will be a power-off Plastic Tape and hold the main button for over 5 seconds. Meantime, all the current display " " and " " if you apply blood too soon. Then you will waste
Pull it off to activate meter. 5. Press any button to exit the self-test and enter Setting Mode. settings will be saved. a test strip.
period during this process.)
9. View window appearance 11. Quality Control Test - Before " " and " " appears, please don't touch the control solution Measuring Range 10-600 mg/dL ( 0.6-33.3 mmol/L )
Make sure your blood sample covers the whole area of the View Window to get To make sure that your blood glucose monitoring system works properly, you to the sample entry on strip because the meter is still in an internal
check. If you do so, the meter will show " " and " ". Test Time 8 seconds
an accurate test result. Insufficient blood sample will cause inaccurate test must perform quality control testing.
result. Repeat the test with a new test strip. 1. Entering Control Solution mode - Don't drip the control solution to sample entry of the strip directly. The Memory Capacity 10 blood glucose test results with date
reagent on strip might be sucked into the bottle of control and time
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 solution and might cause the degeneration of control Power Saving Turn off automatically after 2 minutes no
solution. Doing this might contaminate the meter via the use Press the " " button for 2 seconds.
see " " symbol blinking on the screen indicating that you've successfully
entered the control solution mode. test strip port as well. Operating Temperature 10 ~ 40 ( 50 ~ 104 )
2. Control Solution Test - Don't touch the control solution. If you have touched it,
please clean up with water. Operating Relative Humidity 10 - 90%
Insufficient blood sample Enough blood sample 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 Maintenance Hematocrit 30 - 55%
PRECAUTION perform a control solution test. Keep your meter and test strip free of dust, water or any other liquid. Store the
- Check the expiration date printed on the package every time you use a Power Supply one CR2032 battery
When should perform a quality control test ? meter in the carrying case when not in use. If meter is dropped or damaged,
strip. Do not use expired test strips.
Before doing a blood glucose test with your meter for the first time. perform a quality control test with control solution before doing a blood glucose Battery Life About 1000 tests
- Use each test strip immediately after removing from the vial. test.
When you open and start using a new test strip vial.
- Do not reuse test strips. Meter Dimension 95.0 mm x 43.8 mm x 13.0 mm
When your meter is dropped or splashed with liquids. Cleaning Meter
- Do the test at least 30 minutes after moving into a different location with Whenever you think your test result does not consistent with the way you feel. Clean the outside of the meter with a damp cloth and mild soap/detergent. Meter Weight 43.0 g with batteries
significant change in temperature. Whenever you want to check if your system is working properly or not. Keep the test strip port from getting wet.
- Place the blood drop only on the sample entry of the strip. Whenever you want to practice testing and check correct procedure. Monitor LCD display
- Please don't drip or inject the blood sample directly by 13. Error Message and Trouble Shooting
syringe to the entry port of test strip. Doing this might PRECAUTION Display Area 39.0 mm x 38.0 mm
contaminate the meter or cause damage and is strongly Each time you open a new bottle of Er1 - The inserted strip has been used or
damaged. Please use a new test strip from Meter Storage Conditions -10 ~ 60 ( 14 ~ 140 )
not recommended. Control solution, write the discard date Exp. Date 2008-01
on the label. Control solution is good vial. 4 ~ 30 ( 39 ~ 86 ),< 90% relative
Test Strip Storage Conditions
Blood glucose test results are shown on the meter as mg/dL or mmol/L , for 3 months after opening the bottle, humidity
depending on which unit of measurement you have chosen. Consult your or until the expiration date printed on Er2 - Meter has malfunctioned. Do the quality
control test or reinstall the battery to see Limitations
healthcare professional before making any changes to your diabetes the label, whichever comes first.
if the meter works properly. If error screen still appears, - Blood Glucose Test strips are designed for using with capillary
medication program. Understanding Control Test Results contact Bionime Customer Service. whole blood samples. Do not use serum or plasma samples.
If your blood glucose result is unusually high or low, or if you question your Your control solution test results should fall within the control solution range. - Inaccurate test results may be obtained at high altitude more than about
testing results, repeat the test with a new test strip. You can also run a Quality That means your System is working correctly. Er3 - Signal transmission is disrupted, repeat the test.
10,000 feet ( 3048 meters ) above sea level.
Control Test with Control Solutions to check your meter and strip. If
- Severe dehydration and excessive water loss may cause inaccurately low
the test result still remains unusually high or low, contact your healthcare Control Solution Range Battery Error
Example of control solution range printed results.
professional immediately. 79-107 mg/dL 1. The " " symbol is blinking when the battery
on your test strip vial label. - Blood Glucose Monitoring has not been validated for use on
If you are experiencing symptoms that are not consistent with your blood 4.4-5.9 mmol/L power is low. Please change battery as soon neonates.
glucose test results and you have made sure to follow all instructions of this as you can. You can still do the test. - The glucose test may be interfered under abnormal concentration of
manual, contact your healthcare professional immediately. If control solution test results are out of control solution range, your Uric acid > 9.0 mg/dL ( > 0.54 mmol/L )
The Meter displays results between 10 and 600 mg/dL System may not be working properly. Repeat the quality control test. If your 2. The " " and " " symbols are blinking Cholesterol > 500 mg/dL ( > 13 mmol/L )
control solution results outside the range still exist, do not use the when the battery is too low. Meter can not do
( 0.6 and 33.3 mmol/L). If your test result is below 10 mg/dL ( 0.6 Customer Service
System to test your blood glucose. And contact Bionime authorized distributor the strip test. Please change the battery
mmol/L ), " " will appear on the screen. Please repeat your test We sincerely like to provide complete, considerate services to our customers.
or Bionime Customer Service. immediately.
again by a new strip. If you still get " " result, you should Please review all the instructions to make sure you are performing the steps
The reason your control solution results are out of the range : 3. After changing the battery, perform a quality control test.
immediately contact your healthcare professional. correctly. You are always welcome to contact us by call: 886 4 24951268
- Your control solution has expired or after 3 months since opened.
If your test result is above the high end of the system's detection - Your test strip has expired. Temperature Error ( GMT+08:00, 08:30~17:30 ), or by e-mail at info@bionime.com If you have
range 600 mg/dL ( 33.3 mmol/L ), " " will appear on the screen. - You leave the cap off the vial of test strips or control solution for a long time. In order to get accurate test result, perform testing between 10~40 any question or advice.
Please repeat your test again by a new strip. If you still get " " - You didn't perform the test procedure correctly. ( 50~104 ).
Warranty
result, you should immediately contact your healthcare - Malfunction of the meter. 1. When the ambient temperature is 0~9 ( 32~48) or Bionime Corporation warrants that your Meter will be free from defects in
professional. 41~50 (106~122) the " " warning symbol will be materials and workmanship for five years from the date of purchase.
12. Performing a Quality Control Test
10. Recalling Test Result & Average blinking, you still can do the test but the test result is only for This warranty does not apply to the performance of a Meter that has been
Use with Control Solution reference because the test result under these ranges of altered, misused, tampered with or abused in any way.
The meter is able to store 10 test results with time and date temperature might not be correct. Repeat the test at an area This warranty applies only to the original purchaser of the meter.
1. Take one test strip from vial and Re-cap the vial Please complete and return the enclosed warranty card to Bionime authorized
automatically. If your meter has stored 10 results, which is the maximum with temperature between operating range. ( 10~40 or
cap immediately. representative.
memory of the meter, the newest test result will replace the oldest one. 50~104 )
2. Insert the test strip with view window, facing up, Different models have different specifications. Some of the models are not included with
To recall your test memory, start with the meter without test strip inserted. 2. When you move from the area with temperature outside the
into test strip port. the warranty card.
1. Press the main button to switch the screen to memory function, you will see operating range of test strip to another area with temperature
3. While the blood drop symbol flashing, press and hold the main button for inside operating range of test strip, please wait for 30 minutes Parts of Critical Component
" mem " symbol on the up right corner of the screen. it will show the latest Blood Glucose Meter, Test Strip, Control Solution and Lancing Device
testing result with time and date. The latest result is with sequence number, over 5 seconds until the " " symbol appears. before you do the test. Manufacturer: Bionime Corp.
" 1". 3. When the temperature is below 0 ( 32 ) or over 50 Product complied with In Vitro Diagnostic Medical Device Directive 98/79/EC. ( CE0197 )
4. You will see blinking " " symbol and " " OPEN ( 122 ), Meter can not do the test and the " " symbol will EU Rep: BIONIME GmbH; Heinrich Wild Strasse 202, CH-9435 Heerbrugg / Switzerland
2. Under the memory screen, use main button to review all previous results with symbol on the screen prompting you to apply
blink in this condition. Please move the meter to environment
date and time. You will see results from the most recent ( Sequence no, " 1 " ) control solution. Disposable Sterile Lancets
with temperature between 10~40 ( 50~104 ) and repeat
to the oldest ( Sequence no, " 10 " ) on the down left corner of the screen. 5. Shake the bottle of control solution well before Manufacturer: Vitrex Medical ApS.
the test after 30 minutes.
opening the cap. Then open the cap and put it Product complied with Medical Device Directive 93/42/EEC. ( CE0459 )
3. The meter provides you several average test results. You can
on the table. Sampling Error
view 1-day, 7-day 14-day or 30-day average of test results depending on
Before " " appears. Please don't apply the blood to the entry of IVD For in vitro diagnostic use Manufacturer LOT Lot number
which one you've chosen in setting mode for better blood monitoring of your 6. Drip a drop of control solution on the top of the
the strip because the meter is still doing internal check. If you do
blood glucose. cap. Use by Temperature limitation Do not reuse
so, the meter will show " " and " ". Please remove the
4. Press the main button until the AVG symbol appears on the up left corner of
strip and insert a new one to do the test again. Method of sterilization using irradiation
the screen. The you will see 1-day, 7-day, 14-day or 30-day average of test 7. Gently touch sample entry of the strip with the
results depending on which one you've chosen in setting mode. control solution on the top of the cap. Meter Malfunction
5. The number shown on the down left corner means how many test results are If you find the meter can't be switched on, please follow the steps below for
calculated. 8. When you hear a beep, leave the meter on the CLOSE quick inspection.
6. The " "," " results, the control solution results, the non - average test table while waiting for the test result. 1. Open the battery cover, take out the battery.
results and the test result made out of normal temperature range The screen will display the countdown. 2. Wait for 5 minutes and reload the new battery.
( <10, >40 ) are not calculated in the average. 9. Tightly replace the cap on the control solution The meter should be work normally after finishing above steps. If not, please
bottle. contact Bionime authorized distributor or Customer Service Center.
10. The control solution result appears. Compare your control test result to the
range printed on the test strip vial label. Specification

101-3GM100-010
Measurement Technology Oxidase Electrochemical Sensor
PRECAUTION BIONIME CORPORATION EU Representative:
- Your quality control test result by control solution test will not be Sample Capillary whole blood 694, Renhua Road, Dali City, BIONIME GmbH
PRECAUTION calculated for average reading but still can be recalled. The control Taichung County, Taiwan 412 Heinrich Wild Strasse 202,
- You have to set the time and date to activate the average function. Minimum Sample Volume 1.4 microliter Tel: +886 4 24951268 Fax: +886 4 24952568 CH-9435 Heerbrugg
solution test result will be shown with " " symbol on the screen.

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