BIONIME Rightest GM100 Instruções de utilização - Página 2
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9.
View window appearance
Make sure your blood sample covers
the whole area of the View Window to
g e t a n a c c u r a t e t e s t r e s u l t .
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. If your blood
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 T est with
Rightest
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 steps of this instruction, contact your
healthcare professional immediately.
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
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, "
" 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 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).
PRECAUTION
- You have to set the time and date to activate the average function.
11.
Quality Control Test
T o 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 T est
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.
If you want to purchase new normal or high level control solution, please contact
your authorized Bionime representative.
Understanding Control T est Results
glucose result is
Your control solution test results should fall within the control solution range.
®
That means your
Rightest
System is working correctly.
Control Solution Range
Example of control solution range printed on your test
strip vial label.
79-107 mg/dL
4.4-5.9 mmol/L
If control solution test results are out of control solution range, your
not be working properly. Repeat the quality control test. If your control solution results
outside the range still exist, do not use the
Rightest
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 "
" 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.
If the control solution has
touched you, wash the area 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 vial.
Er2 - Meter has malfunctioned.
test or reinstall the battery to see if the meter
works properly. If error screen still appears,
Exp. Date 2014-03
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.
®
Rightest
System may
Temperature Error
In order to get accurate test result,
®
System to test your blood glucose.
1. When the ambient temperature is 0~9℃ ( 32~48℉ ) or 41~50℃
(106~122℉) the "
" warning symbol will be
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
Meter can not do the test and the "
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 "
OPEN
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.
Specification
CLOSE
Measurement Technology
Sample
Minimum Sample Volume
Measuring Range
Test Time
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
-
Rightest
Do the quality control
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.
-
Rightest
- The glucose test may be interfered under abnormal concentration of
Uric acid≧9.0 mg/dL
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%.
Customer Service
Bionime is committed to providing you with the highest quality of Customer Service. If you
perform
testing between
10~40℃ ( 50~104℉ ).
have any questions, please contact your authorized distributor, in the USA and Canada
please contact Bionime USA toll-free at 1 (888) 481-8485 (Monday through Friday 8:00 AM
blinking, you still can
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
materials and workmanship for five years from the date of purchase.
This warranty does not apply to the performance of a Rightest
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
0℃ ( 32℉ ) or over 50℃ ( 122℉ )
,
representative.
" symbol will blink in this
Different models have different specifications. Some of the models are not included with
the warranty card.
Expected values for normal glucose level
References
1) Diabetes Information - American Association for Clinical Chemistry (AACC)
〔
Electronic Version Retrieved February 08, 2006 from
". Please remove the strip and insert a
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)
Oxidase Electrochemical Sensor
Capillary
whole blood
1.4 microliter
20-600 mg/dL
8 seconds
150 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
Manufacturer:
BIONIME CORPORATION
95.0 mm x 43.8 mm x 13.0 mm
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
43.0 g with batteries
E-mail: [email protected]
http://www.bionime.com
LCD display
39.0 mm x 38.0 mm
-10 ~ 60℃ ( 14 ~ 140℉ )
4 ~ 30℃ ( 39 ~ 86℉ ),< 90% relative humidity
®
Blood Glucose Test Strips are designed for useing with capillary whole blood
®
Blood Glucose Monitoring has not been validated for use on neonates.
Cholesterol≧500 mg/dL
®
Meter will be free from defects in
®
Meter that has been
(1)
Status
Range (mg/dL)
Fasting
70 – 99
〕
USA Service Center:
BIONIME USA CORPORATION
1450 E. Spruce Street, Bldg. #B,
Ontario, CA 91761
Tel: +1 888 481-8485
Fax: +1 909 781-6970