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BIONIME CORPORATION
694, Renhua Road, Dali City,
Taichung County, Taiwan 412
Tel: +886 4 24951268 Fax: +886 4 24952568
E-mail: info@bionime.com http://www.bionime.com
EU Representative:
BIONIME GmbH
Heinrich Wild Strasse 202,
CH-9435 Heerbrugg
Switzerland
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.
- 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
-
The reason your control solution results are out of the range :
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.
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,
testing between
( 50~104
℉
).
perform
10~40
℃
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
℃
( 122
℉
), Meter can not do the test and the " " symbol will
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 " ".
Please remove the
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.
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.
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.
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.
Blood glucose test results are shown on the meter as
or
,
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.
mg/dL
mmol/L
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.
Recalling Test Result & Average
10.
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.
PRECAUTION
-
You have to set the time and date to activate the average function.
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.
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.
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".
Insufficient blood sample
Enough blood sample
View window appearance
9.
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
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 2008-01
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.
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.
Quality Control Test
11.
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.
Understanding Control Test Results
Your control solution test results should fall within the control solution range.
That means your
System is working correctly.
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.
-
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.
-
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 " ".
Measurement Technology
Sample
Minimum Sample Volume
Specification
Oxidase Electrochemical Sensor
Capillary
1.4 microliter
whole blood
Error Message and Trouble Shooting
13.
Er1 -
The inserted strip has been used or
damaged. Please use a new test strip from
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.
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
℉
)
Meter Dimension
Meter Weight
Monitor
Display Area
Meter Storage Conditions
Test Strip Storage Conditions
4 ~ 30
℃
( 39 ~ 86
℉
)
,
< 90% relative
humidity
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
any question or advice.
Warranty
Bionime Corporation warrants that your
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
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. ( CE0197 )
EU Rep: BIONIME GmbH; Heinrich Wild Strasse 202, CH-9435 Heerbrugg / Switzerland
For in vitro diagnostic use
Temperature limitation
Manufacturer
LOT
IVD
Lot number
Use by
Do not reuse
Method of sterilization using irradiation
Hematocrit
Power Supply
Battery Life
30 - 55%
one CR2032 battery
About 1000 tests
Disposable Sterile Lancets
Manufacturer: Vitrex Medical ApS.
Product complied with Medical Device Directive 93/42/EEC. ( CE0459 )
Measuring Range
Test Time
Memory Capacity
Turn off automatically after 2 minutes no
use Press the " " button for 2 seconds.
10 blood glucose test results with date
and time
10-600 mg/dL ( 0.6-33.3 mmol/L )
8 seconds
Power Saving
Operating Temperature
Operating Relative Humidity
10 ~ 40
℃
( 50 ~ 104
℉
)
10 - 90%
OPEN
