BIONIME Rightest GM100 User manual

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
7.
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.
, you'll hear a
sound of " beep ". All the settings are saved and
completed and will return to time screen.
Ending setting
After confirm the Average-day setting
1. Year setting
With the year format blinking, press the main button to adjust it.
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
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.
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.
PRECAUTION
- Re-cap the test strip vial immediately after removing a test strip.
- Do not reuse test strips.
- Do not use expired test strips.
- 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 Rightest GS100 Test Strip Package
Insert.
- Record the date of opening a new strip vial for the first time. Discard the vial of
strips after 3 month from opening.
®
Intended Use
Blood Glucose Monitoring System
Instructions for Use
The
coding is not required.
Rightest® Blood Glucose Monitoring System is intended for In Vitro diagnostic use (
for self-testing ) only ( outside the body ) and The testing result is
calibrated to be plasma equivalent for test with fresh capillary whole blood samples from
the fingertip, palm or forearm. 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
Rightest
Rightest
Rightest
®
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.
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.
®
The Blood Glucose Monitoring System is manufactured by Bionime Corporation
and supported by its authorized representative. If you have any questions or concerns,
please contact your authorized distributor, in the USA and Canada please contact Bionime
USA toll-free at 1 [phone] (Monday through Friday 8:00 AM to 5:00 PM PST).
3 ＊2 ＊1
( Different packages have different bundled items. Some of packages might not include ＊
items.)
The Meter
®
Rightest
3.
Precautions4.
® ®
- 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 on 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 :( )
Rightest Rightest
Rightest
Rightest
Sample Size Example 1.0 1.4 2.0 3.0µL µL µL µL 4 µL .0
The Test Strip ( GS100 Test Strip )
®
Rightest
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.
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.
Please take a minimum of 1.4µl to do the test on glucose monitoring system.
Blood sample size above 4.0µL might contaminate the test strip port.
Blood sample size below 1.4µL might cause inaccurate test result or might not start on
meter measurement. In this case, repeat the test with a new test strip.
Rightest® 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.
Display Window
Shows test results,
messages and related
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
2007-06
1. Rightest Meter
2. Rightest Test Strips (0/10/25 pcs) *
3. Rightest Control Solutions
4. Rightest Instructions for Use
5. Rightest Blood Glucose Test Strip
Package Insert *
6. Rightest Lancing Device *
®
®
® (Normal
Level) *
®
®
®
7. *
8. Disposable Sterile Lancets (10pcs) *
9. Instruction for the lancing device *
10. Log Book
11. Warranty Card + Emergency
12. CR2032 Battery (Inserted into the
meter)
13. Carrying Case *
Clear Cap
7 ＊8 ＊
6 ＊
4
5 ＊
Setting Up Your Meter-Setting the Date, Time
7.
PRECAUTION
- Danger of explosion might happen if the battery is incorrectly replaced.
- Please follow the local regulation and discard a used battery properly.
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.
You can enter Setting Mode by below two ways.
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.
1. Reload battery
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
2. Manual Power off
1) Press the main button.
The meter will power off automatically if you don't operate it over 2 minutes.
If you want to turn off the meter, please keep pressing the main button for 2 seconds.
3. How to turn on the Power
2) Insert one piece of test strip.
PRECAUTION
The unit of measure must be fixed to " mg/dL ". When your display shows " mmol/L
" during setting or test, please contact customer service. Use of the wrong unit of
measure may cause you to incorrect treatment.
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 batteries are replaced. See Setting the
Date, Time and Unit section. Prior test results are still stored in the
memory.
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.
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.
- For detailed information of installing clear Cap of lancing device, please check the
instruction manual for the lancing device.
- Be careful to load the lancing device to avoid being pierced by the needle.
Then you will waste a test strip.
Alternative site testing-palm or forearm blood sampling
10. While the blood drop symbol flashing, you are ready
to apply the blood sample.
best
puncture sites are on the middle or ring fingers.
Press the release button.
11. Place the lancing device against the pad of your
fingertip and press the release button. The
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.
1110
13
1 2 3 4 5
67
9
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. This
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.
16
14
12
15 17
- Before using the Rightest
® System to test your blood glucose, please read all the
instructions and practice performing a test including a quality control test.
- Please do the quality control test regularly to make sure the test results are accurate.
The Rightest blood glucose monitoring system gives you an opportunity to obtain blood
samples from fingertip, palm or forearm.
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.
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. Using the clear cap, follow the above listed steps 1
through 4.
2. Massage the puncture area of palm or forearm for a
few seconds.
3.
clear cap
4. Then press the release button.
5. Continue holding the lancing device against palm or
forearm and gradually increase pressure for a few
seconds until the blood sample size is sufficient.
( Refer to Instruction manual for the lancing device )
Immediately after massaging the puncture area, press
and hold the lancing device with the against
palm or forearm.
9. Insert the strip into the strip port on meter with the
indication symbol facing up.
8. Take one strip from the vial. Re- cap the vial cap
immediately.
6. Hold the hub in one hand and pull on the plunger in
the other hand. The device is now loaded. Release
the plunger, it will automatically move back to its
original position near the hub.
7. Wash your hands with warm soapy water and dry
thoroughly.
Performing a Blood Test
8.
PRECAUTION
- The glucose test results of blood samples taken from different sites might be
varied in certain conditions such as your glucose is changing rapidly following a
drink, a meal, an insulin dose or exercise. In these cases, only 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 of glucose faster than palm or
forearm samples.
- As the blood flow taken from forearm is slower than fingertip or palm, we
recommend using a special lancing device with Clear Cap for testing sites other
than finger.
- If you use normal lancing device for palm or forearm the blood sample might be
not enough for meter.
12
®
Rightest GM100
8
Pressing for
a few seconds
Releasing
button

101-3GM100-114 EN(US)
Battery Error
battery as soon as you can.
You can still do the test.
Meter can not do the strip test.
Please change the battery immediately.
1. The " " symbol is blinking when the battery power
is low. Please change
2. The " " and " " symbols are blinking when the
battery is too low.
3. After changing the battery, perform a quality control
test.
Temperature Error
perform 10~40℃ ( 50~104℉ ).In order to get accurate test result, testing between
1. When the ambient temperature is 0~9℃ ( 32~48℉) or 41~50℃
(106~122℉) the " " warning symbol will be
( 10~40℃ or 50~104℉ )
2.
3. 0℃ ( 32℉ ) or over 50℃ ( 122℉ )
10~40℃ ( 50~104℉ ) and repeat the test after 30 minutes.
Sampling Error
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.
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.
When the temperature is below ,
Meter can not do the test and the " " symbol will blink in this
condition. Please move the meter to environment with temperature
between
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 strip and insert a
new one to do the test again.
Meter Malfunction
1. Open the battery cover, take out the battery.
2. Wait for 5 minutes and reload the new battery.
Specification
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 distributor or Customer Service Center.
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.
- Place the blood drop only on the sample entry of the strip.
- Do the test at least 30 minutes after moving into a different
location with significant change in temperature.
- 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.
The Rightest Meter displays results between 20 and 600 mg/dL. If your
test result is below 20 mg/dL, " " will appear on the screen. Please
" " 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, " " will appear on the screen. Please repeat
" " result, you should immediately contact
your healthcare professional.
®
repeat your test again by a new strip. If you still get
your test again
by a new strip. If you still get
Blood glucose test results are shown on the meter as 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.
healthcare professional immediately.
mg/dL. If your blood
Rightest
If you are experiencing symptoms that are not consistent with your blood glucose test
results and you have made sure to follow all steps of this instruction, contact your
Insufficient blood sample Enough blood sample
View window appearance
9.
Make sure your blood sample covers
the whole area of the View Window to
ge t an acc u r at e te s t re su l t .
Insufficient blood sample will cause
inaccurate test result. Repeat the test
with a new test strip.
Measurement Technology
Sample
Minimum Sample Volume
Measuring Range
Test Time
Oxidase Electrochemical Sensor
Capillary
1.4 microliter
20-600 mg/dL
8 seconds
whole blood
Error Message and Trouble Shooting13.
Er1 - The inserted strip has been used or damaged.
Please use a new test strip from vial.
Er2 - Meter has malfunctioned.
Er3 - Signal transmission is disrupted, repeat the test.
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.
95.0 mm x 43.8 mm x 13.0 mm
43.0 g with batteries
Meter Dimension
Meter Weight
Limitations
- Blood Glucose Test Strips are designed for useing 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 Cholesterol≧500 mg/dL
Rightest
Rightest
®
®
Memory Capacity
Power Saving
Operating Temperature
Operating Relative Humidity
Hematocrit
Power Supply
Battery Life
Turn off automatically after 2 minutes no use
Press the " " button for 2 seconds.
150 blood glucose test results with date and
time
10 ~ 40℃ ( 50 ~ 104℉ )
10 - 90%
30 - 55%
one CR2032 battery
About 1000 tests
NOTE
Acetaminophen, Ascorbic acid (Vitamin C), Dopamine, Ibuprofen, Salicylic Acid,
Tetracycline, Bilirubin-conjugated, Creatinine, Triglyceride, Maltose, Xylose,
Galactose and Lactose (when occurring in normal blood or normal therapeutic
concentrations) do not significantly affect results (the bias of interference is below
10%). However, abnormally high concentrations of these interferents in blood may
cause inaccurate results.
In addition when blood glucose concentration drops below 70mg/dL, the bias of
interference with the presence of L-dopa and methyldopa may be slightly higher
than 10%.
References
1) Diabetes Information - American Association for Clinical Chemistry (AACC)
Electronic Version Retrieved February 08, 2006 from
www.labtestsonline.org/understanding/analytes/glucose/test.html
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)
EU Rep: Klaus Ellensohn, Tschuetschgasse 8, 6833 Klaus / Vlbg., Austria
Disposable Sterile Lancets
Manufacturer: SteriLance Medical (SuZhou) Inc.
EU Rep: EMERGO EUROPE, Molenstraat 15, 2513 BH The Hague, The Netherlands.
(CE0197)
〔 〕
Status
Fasting
Range (mg/dL)
70 – 99
Expected values for normal glucose level (1)
Customer Service
Bionime is committed to providing you with the highest quality of Customer Service. If you
have any questions, please contact your authorized distributor, in the USA and Canada
please contact Bionime USA toll-free at 1 [phone] (Monday through Friday 8:00 AM
to 5:00 PM PST). Or e-mail at [email protected]
For 24 hour assistance please contact your healthcare provider. Review the instructions to
ensure that the correct testing procedure has been followed.
Warranty
Bionime Corporation warrants that your Rightest 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 Rightest 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.
®
®
Manufacturer:
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
E-mail: [email protected]
http://www.bionime.com
USA Service Center:
BIONIME USA CORPORATION
1450 E. Spruce Street, Bldg. #B,
Ontario, CA 91761
Tel: [phone]
Fax: [phone]
®
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 :
Rightest
Rightest
- our 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
-
Y
dure correctly.
Malfunction of the meter.
Performing a Quality Control Test 12.
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.
Use with Control Solution
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.
CLOSE
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.
Recalling Test Result & Average10.
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.
Exp. Date 2014-03
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.
To make sure that your blood glucose monitoring system works properly, you must perform
quality control testing.
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.
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.
Quality Control Test11.
PRECAUTION
-
" "
- 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 " " and " ".
- 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.
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.
If the control solution has
touched you, wash the area with water.
Example of control solution range printed on your test
strip vial label.
Control Solution Range
79-107 mg/dL
4.4-5.9 mmol/L
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.
OPEN
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.
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).
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.
PRECAUTION
- You have to set the time and date to activate the average function.
If you want to purchase new normal or high level control solution, please contact
your authorized Bionime representative.
Understanding Control Test Results
Your control solution test results should fall within the control solution range.
®
That means your System is working correctly. Rightest
Monitor
Display Area
Meter Storage Conditions
Test Strip Storage Conditions
LCD display
39.0 mm x 38.0 mm
-10 ~ 60℃ ( 14 ~ 140℉ )
4 ~ 30℃ ( 39 ~ 86℉ ),< 90% relative humidity