Standard Gluco Navii GDH Manual

1. Product Structure
List of the system
GDH
STANDARD GlucoNavii GDH STANDARD Glucose
Blood Glucose Meter Check Strip
<Option>
• STANDARD GlucoNavii GDH Blood Glucose Test Strips
• Lancing Device (with a white cap for fingertip testing and a clear cap for Alternative Site
Testing)
• Lancet
• STANDARD GlucoNavii Control Solution
STANDARD GlucoNavii GDH Blood Glucose Meter
Display
Shows blood
glucose result, mes-
sages, and glucose
result stored in
memory.
Arrow Buttons
Used for meter
setup and review of
memory moving to
the right and left.
ON/OFF Button
Press to turn meter
ON or OFF.
Test Strip Slot
Insert test strip
here.
STANDARD GlucoNavii GDH Blood Glucose Test Strips
Yellow Window
(Top Edge)
Apply a drop of blood here.
-Before Applying Blood-
This window should be completely yellow.
-After Applying Blood-
This window should be completely lled with the blood drop.
Electrodes
Insert strip with gold-coloured bars up and toward the meter
* After pulling out the test strip
from a container, close the contain-
er cap of the test strip immediately.
CAUTION
Important steps for using this system are inside this guide. Please read it carefully.
If you have questions, we are here to help.
Please contact SD Biosensor, Inc.
Tel : +82-31-300-0400 Fax : +82-31-300-0499
website : www.sdbiosensor.com
We offer assistance 24 hours a day, 365 days a year in many languages. You can also visit
www.sdbiosensor.com for diabetes management tools and product demonstrations.
Please refer to the instructions with following symbols in this User Instruction Guide.
To identify conditions or practices that could result in damage to equip-
ment or other property.
CAUTION
To provide an additional useful information.
NOTE
CHAPTER 1: Understanding Your New System
1. Intended Use
Your new STANDARD GlucoNavii GDH Blood Glucose Meter and accessories work
together to measure the amount of glucose (sugar) in your blood. Your STANDARD
GlucoNavii GDH Blood Glucose Monitoring System is indicated for monitoring glucose
in fresh capillary whole blood or fresh venous blood or arterial blood. STANDARD
GlucoNavii GDH Blood Glucose Monitoring System is suitable for self-testing and
testing is done outside the body. (in vitro diagnostic use) This system is indicated for
home (over-the-counter or OTC) by person with diabetes, or in clinical settings by
healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This
system should not be used for the diagnosis of diabetes or for testing neonates for self-
testing use. The measurement using the venous, arterial and neonatal blood should be
done by healthcare professionals.
2. Product Description and the Principle of the use
STANDARD GlucoNavii GDH Blood Glucose Test Strip is designed with an electrode that
measures glucose levels. Glucose in the blood sample mixes with reagent on the test
strip that cause a small electric current. The amount of current that is created depends
on how much glucose is in the blood.
STANDARD GlucoNavii GDH Blood Glucose Meter measures the current that is created
and converts the measurement to the amount of glucose that is in the blood. The blood
glucose result is displayed on the meter's LCD display. By touching a drop of blood to
the tip of the test strip, the strip's reaction chamber automatically draws the blood into
the strip through capillary action. When the chamber is full, the meter start to measure
the blood glucose level. It is a simple and practical system for the daily monitoring of
your blood glucose level.
3. Reagent Composition: Active Ingredient (per 100 strips)
Glucose dehydrogenase (GDH) 39.2 units
Potassium ferricyanide (mediator) 1.9 mg
4. Meter Set up
STEP-1 : Setting the Audible Beep
1. In Strip Stand-by Display, if you press the ON/OFF button during 3 seconds, the
display for setting the beep will appear, the first step of the setting mode.
2. Set the beep mode on or off by pressing either the left or the right button and
then selecting the preferred feature by pressing the ON/OFF button. If you select
the beep on feature, a 'beep' sound is made at the same time; otherwise, if you
select the beep off feature, no sound is made.
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Lancing Device / Lancet
Cap & Comfort dial
with puncture depth selection
3V battery type
CR2032
1
Data port
Download test results
to a personal computer.
(If you have software)
Turn the lancet insert cap counterclockwise to
Battery Cover
remove it.
Remove cover to
change battery.
3
Replace the cap and turn it clockwise, until it is
snug.
5
Cock the lancing device back.
STEP-2: Setting the Hypo warning
• You can set the meter to let you know when your result indicates a
possible low blood glucose (hypoglycemia). You can also select what
blood glucose level you want this indicator to have 60, 70, 80 mg/dL
(3.3, 3.9, 4.4 mmol/L).
• If your results are lower than selected hypo result, the hypo icon will
NOTE
appear on LCD with a 'beep' sound. It is very important to manage your
hypoglycemia.
1. After beep setting, the display for setting the hypo warning will appear, the
second of setting mode.
2. Set the hypo warning mode 'off' or the result you want to select among 60, 70, 80
mg/dL(3.3, 3.9, 4.4 mmol/L) by pressing either the left or the right button and then
selecting the preferred feature by pressing the ON/OFF button.
Set the hypo warning mode 'off' or the result you want to select among
60, 70, 80 mg/dL(3.3, 3.9, 4.4 mmol/L) by pressing either the left or the
right button and then selecting the preferred feature by pressing the ON/
NOTE
OFF button.
STEP-3: Setting the date and time
[ Date Setting ]
1. The third step of setting mode is the Date & Time setting. After setting the hypo
warning, the display for setting Date & Time will appear, the third step of the setting
mode. Set the correct year by pressing either the left or the right button and then
select the correct year by pressing the ON/OFF button.
2. Next will appear the setting display for month and day format. The meter can
display the month and day in either a Month-Day (m-d) format or a Day-Month
(d-m) format.
3. Set the preferred format on the display by pressing either the left or the right
button and select by pressing the ON/OFF button.
[ Time Setting ]
1. Next will appear the display for setting the 12 or 24 Hour clock format. The meter
can display the time in either the 12h format or the 24h format. Set the preferred
format on the display by pressing either the left or the right button and select by
pressing the ON/OFF button.
2. Next will appear the setting display for time format. Set the correct hour and
minute on the display by pressing either the left or the right button and select the
correct time by pressing the ON/OFF button.
STEP-4: Post-meal alarm
You can use the meter's post-meal alarm function to remind you to test your blood glucose
after meal.
1. After day and time setting, the display for setting the post-meal alarm will appear,
the fourth of setting mode.
2. Set the post-meal alarm mode '2h' or 'off' by pressing either the left or the right
button and then select the preferred feature by pressing the ON/OFF button.
2. Blood Collection
Release Button
Arming Knob
Lancet
2
Insert the lancet into the lancing device holder
and push down firmly until it is fully seated. Twist
the lancet protective disk until it separates from
the lancet.
4
Adjust the puncture depth setting by turning the
comfort dial. The dial has 1 to 5 steps, and the
higher the step number, the stronger the blood
sampling pressure on the puncture site.
6
Hold the lancing device firmly against the side of
finger and then press the release button.
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3. Test Procedure
1
GDH
Insert the 3V battery (type CR2032) into the compartment with "+" side facing you.
2
Insert the test strip into test strip slot until it will go no further with gold-colored bars printed
' ' symbol facing up and toward the meter. Then, the meter turns on automatically.
3
Obtain a drop of blood sample using the lancet and lancing device.
4
Touch and hold drop of blood to the edge of the strip until the yellow window is completely
filled with blood. The blood will be drawn into the strip automatically.
CAUTION
• If you select the post-meal alarm '2h' feature and test with pre-meal
mark, the 'clock symbol' will appear on result display and the 'beep'
sound will be made in 2 hours to remind you to test your blood
glucose after meal for 1mimute.
• If you perform the pre-meal test while the post-meal alarm setting is
on, then the post-meal mark will appear automatically on your LCD
NOTE
when you test within following period: from 30min to 130min after
your pre-meal test.
• If you mark the new test result with a pre-meal mark, the old alarm
setting will be ignored and only the new setting will sound in 2 hours.
STEP-5: Setting the alarm
You can use the meter's alarm function to remind you to test your blood glucose.
1. After Post-meal alarm setting the display for setting the alarm will appear, the fifth
of setting mode.
2. Set the first alarm on or off by pressing either the left or the right button and then
select the preferred feature by pressing the ON/OFF button.
• If you select the alarm off feature, next will appear the Strip Standby
Display.
• If you select the alarm on feature, you can set the alarm up to four
NOTE
times a day at any time you want.
3. If you select the alarm on feature in first alarm mode, the clock will blink. Set the
correct time and minute you want to set an alarm on the display by pressing either
the left or the right button and then select the preferred feature by pressing the
ON/OFF button.
If you select the alarm off feature in first (also second, third and fourth)
alarm mode, next will appear the Strip Stand-by Display.
NOTE
4. If you finish setting the first alarm, next will appear the second alarm setting mode.
Set the alarm with the same way as above. [2, 3]
5. You can set the third and fourth alarm mode with the same way as above. [2, 3]
6. If you finish setting the last alarm, next appear at the strip-stand by display.
5. Precaution and Warning
• STANDARD GlucoNavii GDH Blood Glucose Monitoring System is not designed to
be a substitute for pathology laboratory equipment and should not be used for the
diagnosis of diabetes.
• Do not use STANDARD GlucoNavii GDH Blood Glucose Monitoring System to test
neonates for self-testing use. Only professional can use this system for neonatal use.
• Never make significant changes to your diabetes control program or ignore
physical symptom without consulting with your healthcare professional.
• Do not use this device to measure blood glucose in people who are experiencing
cardiovascular collapse (severe shock) or decreased peripheral blood flow.
[Meter]
• Keep the test strip slot free of dust.
• Protect the internal meter from humidity.
• The carrying case is designed to let you store a variety of supplies you may need
and helps to protect your meter.
• If you keep the meter with the battery inserted, then keep it in a low humidity
environment.
[ Test Strip ]
• Only use STANDARD GlucoNavii GDH Blood Glucose Test Strips. Using other test
strips with this meter can cause inaccurate results or E-1 error message.
• After removing a test strip from the container, replace the container cap
immediately and close it tightly.
• Store test strip containers in a cool, dry place at 2-32°C(36-90°F). Keep away from
direct sunlight and heat. Do Not refrigerate test strips.
• Do Not expose strips to heat, moisture or humidity. Temperatures outside the