SD Biosensor 01GM24 NFC Blood Glucose Monitor User Manual Link part2 manual

SD Biosensor, Inc. NFC Blood Glucose Monitor Link part2 manual

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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
4)
After cocking the lancing device back, hold the lancing
device firmly against the side of finger and then press
the release button.
CAUTION
t
A lancet should only be used once. Do not
share used lancets with another person. To
prevent possible infection, a used lancet
should not be touched by another person.
Used lancets in the regular trash can be
dangerous. We recommend that you throw
out the used lancets in sharps containers or
test strip vials. Please be sure to save the cap
so that the lancets cannot spill out of the
container into the trash.
Testing Your Blood Sugar
t
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
2. Performing a Blood Glucose Test
NOTE
1)
2)
Always wash hands with warm, soapy water. Rinse
and dry them before testing.
Remove a new test strip from container. Be sure to tightly
replace container cap after removing test strip.
Make sure the meter turn off. And then, insert the test strip
into the meter.
Testing Your Blood Sugar
Link0.3
3)
When the blood drop symbol flashes (Blood Stand-by
Display), you are ready to perform a test.
4)
Let your arm hang down at your side to allow blood to
flow to your fingertips. Grasp your finger just below the
joint closest to the fingertip.
Obtain a drop of blood sample using the lancet and
lancing device.
Hold your finger to the tip of the strip until the yellow
window is completely filled with blood. Do not place the
blood drop on top of the strip.
5)
6)
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
8)
9)
The blood will be drawn into the strip automatically. If
beeper is turned on, meter will beep to let you know the
test is beginning.
When blood is applied to the strip, start the test. After 5
seconds, the test result appears on the screen.
You can set the pre-meal or post-meal test if you want. The
symbol indicating pre-meal( ) or post-meal( ) appears
on the screen. Choose what you want by pressing the left
or right button. If you press the On/Off button, no select
any features.
10) When the test is done, pull out the used test strip and
discard it.
t
t
NOTE
t
Remove the inserted lancet from the lancing
device and dispose the used lancet with care.
Always use fresh capillary or venous whole blood
for tests.
If you want to use NFC function, refer to ‘Chapter
4. Using the NFC function’ on page 40~44 .
Testing Your Blood Sugar
7)
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
3. Understanding Test Results
Your test results
1. After 5 seconds testing time from applying a blood
into strip, you will receive a normal result, 10mg/dL
to 600mg/dL.
CAUTION
Testing Your Blood Sugar
2.
If you perform the pre-meal test while the postmeal alarm setting is on, then the post-meal mark
will appear automatically on your LCD when
you test within following period: from 30min to
130min after your Pre-meal test.
If your blood glucose is above 600 mg/dL, you
will receive a “HI” and is below 10 mg/dL, you will
receive “Lo”. In these cases, repeat the test with new
test strip. If this message show again, contact your
healthcare professional immediately.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Normal Blood Glucose Readings
The normal fasting blood glucose range for an adult
without diabetes is 74 - 106 mg/dL.2
Two hours after meals, the blood glucose range for an
adult without diabetes is less than 140 mg/dL.1
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What This Means For You
Frequent blood glucose testing is the best means to track
how well you are doing with your diabetes management.
It helps you track the effects of medications, diet, exercise,
and stress management. Blood glucose test results can
also tell you if your diabetes is changing. This may alert
you to adjust your treatment plan. Always consult your
healthcare professional before making any adjustments.
Testing Your Blood Sugar
Frequency of Testing
Work with your healthcare professional to decide when
and how often to test. This will depend on such things as
age, type of diabetes, and medications. It is important to
make testing part of your daily routine.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Chapter 4:
Using NFC function
1. Information on NFC function
NFC(Near field communication) is a set of standards for smartphones
and similar devices to establish radio communication with each
other by touching them together or bringing them into close
proximit.
This function is comfortable for test results back-up at PC or
smartphones. So, you can easily monitor your blood glucose
results.
SD GlucoNavii® Link0.3 NFC follows “Felica” standard which
include ISO/IEC 18092.
Using NFC function
2. Information on Caution for NFC
t
Check your smatphone or PC OS version. For PC, It is
available for Windows XP, Windows VISTA, Windows 7 and
need to NFC Reader/Writer purchased separately.
t
For smartphone, It is available for only smartphones with
Android OS v.2.3.1 or higher. Check the list in www.nfcworld.
com/nfc-data/android/.
Before using this function, check the meter turn off. If turn
the meter on, you cannot use NFC function.
Check the location of chip for NFC in your smartphone. It
is different by manufacturer. For more information, refer to
manufacturer website of your smartphone.
SD NFC software for PC is able to download at www.
sdbiosensor.com .
If the distance between the meter and a smartphone(or NFC
Reader/Writer) is far(about over 2cm/0.06ft), NFC function is
not operated.
t
t
t
t
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
3. Using NFC function
1)
2)
Check the location of NFC at your smartphone.
If you tap SD GlucoNaviiÂŽ Link0.3 NFC to your
smartphone, two kinds of action are happened. First,
start GlucoNavii App., seconds, upload the glucose
results stored in SD GlucoNaviiÂŽ Link0.3 NFC meter to
smartphone.
3)
After finishing the communication, check that the test
results are transferred well in your smartphone or PC.
More information on App or software for PC, refer to
each manual.
Using NFC function
NOTE
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
4. How to use GlucoNavii App
1)
Download & Install
t
Search ‘GlucoNavii’ in Google Play at your
smartphone. You can search other keyword that
are ‘SD Biosensor’.
t
Install GlucoNavii App. in your smartphone.
NFC enabled smartphone with Android OS v.2.3.1 or
higher.
Check the list in http://www.nfcworld.com/nfc-data/
android/.
NOTE
t
2)
Check the NFC function at your smartphone. If it is
the ‘Off’ setting, turn NFC function ‘On’.
Communicate with SD GlucoNaviiÂŽ Link0.3 NFC meter
t
If you tap SD GlucoNaviiÂŽ Link0.3 NFC meter to
your smart-phone, two kinds of action will be
happened. First, if App. is not turning it on, start
App. Seconds, if App. is already running, please,
wait a minute to upload test results.
Please remember the points of contact for both devices.
NOTE
Using NFC function
3)
Utilize GlucoNavii App
(1) Start App.
(2) If you need to upload new data, just tap SD GlucoNavii
Link0.3 NFC meter to your smartphone.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
5. How to use GlucoNavii DMS for PC
1)
2)
3)
4)
NOTE
Download the software at www.sdbiosensor.com. And
then, start the software.
Turn the meter off. If not, you cannot start NFC function.
Tap the meter with NFC Reader/Writer plugged with PC.
And then, start the communication.
After finishing the communication, you can look the log
book(test results) or graph.
More information on App or software for PC, refer to
each manual.
If you have any question or queries about GlucoNavii
App.or GlucoNavii DMS for PC, please email to (SD_Dev@
sdbiosensor.com).
European Union Directive Conformance Statement
Hereby, SD Biosensor declares that SD GlucoNaviiÂŽ
Link0.3 NFC blood glucose meter is in compliance
with the essential requirements and other relevant
provisions of Directive 1999/5/EC.
You can view your product’s Declaration of
Conformity(DoC) to Derictives 1995/5/EC(R&TTE)
Directive at www.sdbiosensor.com.
CAUTION
WARNING: Changes or modifications made to this
equipment not expressly approved by SD Biosensor,
Inc. for compliance could void the user’s authority to
operate the equipment.
Using NFC function
NOTE
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Using NFC function
NOTE
This equipment has been tested and found to comply
with the limits for a Class B digital device, pursuant
to Part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful
interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a particular installation.
If this equipment does cause harmful interference to
radio or television reception, which can be determined
by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or
more of the following measures:
t
Reorient or relocate the receiving antenna.
t
Increase the separation between the equipment
and receiver.
t
Connect the equipment into an outlet on a circuit
different.
t
from that to which the receiver is connected.
t
Consult the dealer or an experienced radio/TV
technician for help.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
CHAPTER 5 :
Using the Meter Memory
Using the Meter Memory
The meter automatically stores about 300 glucose results,
letting your review them in order from the most recent to
the oldest. If you have set the time/date feature, the time
and date of the results are also displayed. If the memory is
full and a new result is added, the meter deletes the oldest
result.
The meter also calculates three kinds of 7, 14 and 30-day
averages of test results stored in memory, 1)normal, 2)premeal and 3)post-meal state averages. You do not need to
set the time and date for the meter to give you average
calculations. HI/Lo result (results outside of the meter’s
reading range) and results with control solution symbol are
not included in averages.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
1. Searching Test Results
1)
In Strip Stand-by Display, press the left arrow button
to review in sequence from the most recent test result
to the last test results stored in memory.
Link0.3
[ Left button ]
Using the Meter Memory
[Normal result]
[Pre-meal result]
[Post-meal result]
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
[Control Solution result]
If there aren’t the stored test results, the following
display appears for 1 second, and then the meter will
display Strip Stand-by Display automatically.
Using the Meter Memory
2)
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
3)
In Strip Stand-by Display, press the right arrow button
to review three kinds of 7,14 and 30 day averages of
test result stored in memory in sequence. (normal,
pre-meal and post-meal state) You can also review the
number of results at each average in the right bottom
of the LCD window. If you press the right arrow button
once more after displaying the 30 day average(with
post-meal mark), the 7-day average result appear
again.
Using the Meter Memory
[ Normal average ]
[Pre-meal average]
[Post-meal average]
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
NOTE
If there aren’t any stored 7, 14 and 30-day average of
test results, following display will appear on the LCD.
You cannot search the stored test results and
average of results in the meter, if a test strip is
inserted in the meter, Blood Stand-by Display.
After removing the test strip from the meter, you
can search the test results and average of results
stored in memory by pressing the left or the right
button.
Using the Meter Memory
4)
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
2. Downloading results to a computer
You can use your meter with GlucoNavii DMS to store your
records and to help you spot patterns for planning meals,
exercise, and medication.
GlucoNavii DMS puts information downloaded from the
meter into charts, diagrams and graphs.
1)
2)
Using the Meter Memory
NOTE
Obtain the GlucoNavii DMS and NFC Reader/Writer.
Install the software on a personal computer. Please
refer to Software Product Manual.
t While the meter is connected to the PC, it is
unable to perform a blood glucose test.
t For downloading GlucoNavii DMS and Software
Product manual(both are free of charge), please
visit www.sdbiosensor.com.
t For ordering NFC Reader/Writer, please contact
our representative.
t For more information,please refer to Software
Product Manual. If the cable port got ESD while
downloading data, time delay, a few seconds, may
be happened. After a while, the meter retransmit
data automatically.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
CHAPTER 6 :
Maintenance and Troubleshooting
1. Performing Check strip Test
When you do the check strip test?
t
When you want to easily check the performance of the
meter.
t
Before using your meter for the first time.
t
Whenever your result does not agree with the level
you feel.
t
If you have repeated a test and the blood glucose
result is still lower or higher than expected.
Check Strip test does not replace Control Solution
test.
How to Use the check strip
1. Insert SD Glucose Check strip (facing up ‘Check strip’
printed in arming knob) into test strip slot. The meter
turns on automatically.
2. If the check strip is inserted properly, the meter will
start the check.
Link0.3
Check
Strip
Check
Strip
Maintenance and Troubleshooting
CAUTION
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
3.
The check result appears on the screen in 5 seconds.
‘OK’ message appears on the screen if there isn’t any
problem for the meter. If not, ‘EEE’ message appears
on the screen.
[ ‘OK’
Message ]
[ ‘EEE’
Message ]
Maintenance and Troubleshooting
2. Cleaning the meter
Caring for SD GlucoNaviiÂŽ Link0.3 NFC meter is easy. Just
keep it free of dust. If you need to clean it, follow these
guideline carefully to help you get the best performance
possible.
To prevent malfunction of the meter, keep the test strip
port free of blood, moisture, dirt, or dust. Use a lint-free
cloth dampened with water to clean meter. Thoroughly
wring out cloth before use. Do not use an abrasive cloth
or antiseptic solution, as these may damage the display
screen.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
3. Maintenance, Testing and Transportation
Precautions for Maintenance, Testing and Transportation
1) Meter
t
Keep the test strip slot free of dust.
t
Protect the internal meter from humidity.
t
The carrying case is designed to let you store a variety
of supplies you may need and helps to protect your
meter.
t
If you keep the meter with the battery inserted, then
keep it in a low humidity environment.
t
Do not modify the meter, such as resembling or
remodeling, NFC function is not operated well. If any
function is not perated, please contact SD Biosensor,
Inc.
2) Test strip
t
The test strip is sensitive to humidity, keep it in a dry
and cool environment, and do not store in direct
sunlight.
t
After pulling out the test strip from its container, close
a container cap of the test strip immediately.
t
The test strip container closes tightly and can protect
the test strips, so you should keep the unused test
strips in the container in which they came.
Maintenance and Troubleshooting
The meter needs little or no maintenance with normal use.
It automatically tests its own systems every time you turn it
on and lets you know if something is wrong. If you drop the
meter or think it is not giving accurate results, make sure
that your test strips and control solution haven’t expired,
and then run a control solution test.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Maintenance and Troubleshooting
3) Lancet and Lancing device
t
The needle of lancet is sharp, keep the lancet away from
children.
t
Keep the lancet and lancing device dry and do not store
in direct sunlight, or high heat and humidity locations.
t
A lancet should not use for the other intended use except
sampling blood.
t
A lancet is for single use only. Do not reuse.
t
A lancet provided with SD GlucoNaviiÂŽ Link0.3 NFC
Blood glucose meter is able to use every lancing devices
manufactured by other company. But if at all possible,
use the lancing device manufactured by SD Biosensor,
Inc.
t
Before using, check a packaging condition, if there is any
problem, you should not use it.
t
If a lancet protective disk is loosed or needle of a lancet is
exposed, you should not use it.
t
To reduce the chance of infection for the used lancet,
discard it.
4) Control solution
t
Keep SD Glucose control solution in 8-30°C (46-86°F)
environment.
t
Do not refrigerate or freeze.
t
Do not use SD Glucose control solution that has
passed the expiration date.
t
SD Glucose control solution can be used for 3 months
after opening the container. Write the opened date on
the container when you first opened.
t
No reconstitution or dilution is necessary.
t
Wipe the container tip clean and reseal the container
tightly after each use.
4. Cleaning the Lancing Device
Clean the outside of SD lancing device regularly with
70% isopropyl (rubbing) alcohol. Do not place the entire
device under water. Do not use bleach. At least once a
week, disinfect the cap after cleaning by placing it in 70%
rubbing alcohol for 10 minutes. Allow the cap to air-dry
after disinfecting.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
5. Screen Messages and Troubleshooting
Message Description
t
The meter turns on normally.
[Blood Stand-by Display]
t
The meter is ready for a drop of
blood.
Maintenance and Troubleshooting
[Strip Stand-by Display]
t
The meter is ready for you to
insert a test strip.
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The meter shows the test result.
Maintenance and Troubleshooting
t
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
t
The meter shows three kinds of average of results.
[Normal Results Average]
[Post-meal Results Average]
Maintenance and Troubleshooting
[Pre-meal Results Average]
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Maintenance and Troubleshooting
SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
t
The meter shows the saved results of blood glucose.
t
The meter is ready for a drop of control solution.
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t
t
[Low battery]
At this time, battery is getting low but you can still
perform about 50 tests. Replace the battery soon.
See Chapter 1 “9. Changing the Battery”.
[Replace battery]
Battery power is low. Replace the
battery immediately. See Chapter
1 “9. Changing the Battery”. If you
press the ON/OFF button after
discharging of the battery, the
battery icon will flash and then
after ten seconds the meter will
turn off automatically.
[HI message]
Blood glucose may be higher than
the measuring range of the system.
See chapter 3 “4. Understanding
Test Results”.
Maintenance and Troubleshooting
t
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
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Maintenance and Troubleshooting
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[Lo message]
Blood glucose may be lower than
the measuring range of the system.
See chapter 3 “4. Understanding
Test Results”.
[Internal Error Message for a meter]
Turn off a meter. Then turn on
the meter again. If there is still
error message, please contact SD
Biosensor, Inc. TEL: +82-31-300-0400.
[Strip Error]
Defective test strip or the test strip is damaged or
inserted improperly. Discard this test
strip and test again using new test
strip. See Chapter 3 “2. Performing a
Blood Glucose Test”.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
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t
[Blood Sample Error]
An insufficient amount of blood was
applied. Discard this test strip and test
again using new test strip and a larger
sample, making sure blood is placed
to the narrow channel in the top edge
of the test strip. See Chapter 3 “2.
Performing a Blood Glucose Test”.
[Temperature Error]
If the environmental temperature is
above or below the operating range
of a meter, a thermometer icon will
appear on the display. Move to an
area between 8-45°C (46-113°F),
wait for 30 minutes, and perform a
test. Do not artificially heat or cool
the meter. See Chapter 6. “Product
Technical Information”.
[Communication Error]
The communication between meter
and computer is failed. Connect
again between meter and PC.
Maintenance and Troubleshooting
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
6. Warnings, Precautions and Limitations
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Maintenance and Troubleshooting
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Never make significant changes to your diabetes
control program or ignore physical symptom without
consulting with your healthcare professional.
Severe dehydration (excessive water loss) may cause
false low results. If you believe you are suffering from
dehydration, consult your healthcare professional
right away.
Extremes in hematocrit may affect test results.
Hematocrit levels less than 20% may cause falsely high
readings. Hematocrit levels greater than 60% may
cause falsely low readings.
Inaccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate low
results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without
ketosis. Critically ill patients should not be tested with
blood glucose meters.
Normal endogenous (within body) natural levels
of uric acid, ascorbic acid (vitamin C), bilirubin,
triglycerides, and hemoglobin do not interfere with
your blood glucose results obtained.
Interferences : The following compounds, elevated
levels of ascorbic acid, uric acid, acetaminophen, total
bilirubin, triglycerides may affect results.
Compound
Limitation
Ascorbic acid
> 4 mg/dL
Uric acid
> 9 mg/dL
Acetaminophen
> 6 mg/dL
Total bilirubin
> 40 mg/dL
Triglycerides
> 1026 mg/dL
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Maintenance and Troubleshooting
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Do not use during or soon after xylose absorption
testing. Xylose in the blood will cause an interference.
SD GlucoNaviiÂŽ Link0.3 NFC 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 SD GlucoNaviiÂŽ Link0.3 NFC meter to test
neonates. It has not been validated for neonatal use.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
CHAPTER 7 :
Product Technical Information
1. System Specifications
Result Range
10 - 600 mg/dL,
(0.6 - 33.3 mmol/L)
Calibration
Plasma-equivalent
Sample
Fresh capillary whole blood
Sample Size
0.3 microliter
Test Time
5 seconds
Product Technical Information
Assay
Method
ON/OFF
Source
Glucose Oxidase Biosensor
One replaceable 3 V Lithium Battery type
CR2032
Battery Life
Around 1,000 tests
Glucose Unit
mg/dL , mmol/L
Display
LCD (Customized)
Controls
3 Buttons
Size
48 mm × 90 mm × 15 mm
Weight
50g (with battery)
t
Automatic
Shutoff
t
1 minutes after last user action
without inserting test strip into the
meter
3 minutes after last user action when
inserting test strip into the meter
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Memory
300 blood glucose tests
Function
- Hypo warning : 60, 70, 80 mg/dL(3.3, 3.9,
4.4 mmol/L)
- Pre-meal and post-meal mark
- Alarm setting (up to 4 times)
- Post-meal Alarm
- 7-, 14- and 30-day Averages of the
following results
1)Normal Results
2)Pre-meal Results
3)Post-meal Results
- Automatic shutoff
Operation
Temperature
10 - 45°C (48 - 113°F)
Hematocrit
20 - 60%
Altitude
Up to 12,388 feet. (3,776 meters)
- Test strip
Storage
Temperature
2°C – 32°C (36°F – 90°F)
Product Technical Information
- System
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Annex 1 : Information for Healthcare Professionals
Product Technical Information
Healthcare professionals : Follow the infection control
procedures appropriate for your facility.
Decisions about whether to recommend alternative site
testing (AST) should take into account the motivation and
knowledge level of the patient and his or her ability to
understand the considerations relative to diabetes and
AST. If you are considering recommending AST for your
patients, you need to understand that there is a potential
for a significant difference between fingertip and alternative
site blood glucose test results. The difference in capillary
bed concentration and blood perfusion throughout the
body can lead to sample site-to-site differences in glucose
results. These physiological effects vary between individuals
and can vary within a single individual based upon his or
her behavior and relative physical condition. Our studies
involving AST of adults with diabetes show that most
persons will find their glucose level changes more quickly in
the fingers’ blood than the alternative sites’ blood.
This is especially important when glucose levels are falling
or rising rapidly. If your patient is used to making treatment
decisions based upon fingertip readings, he or she should
consider the delay or lag-time, affecting the reading
obtained from an alternative site.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Annex 2 : Symbol
The following list describes all symbols used on SD
GlucoNaviiÂŽ Link0.3 NFC Blood glucose monitoring (BGM)
system.
Symbol
Description
Caution, consult accompanying
documents
Battery type used in this meter
Crossed out wheeled bin: To discard it
separately from other household waste
In-vitro diagnostic medical device:
This system is intended to use outside the
body (in vitro diagnostic use).
Serial number for this meter.
Date of manufacture :
To indicate the date of manufacture for this
meter
Product Technical Information
Consult instructions for use
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Symbol
Description
Lot No. or Batch Code
To indicate the lot number for this
system
Expiry date:
This system should be used by the
given date.
To indicate the temperature
limitations in which the transport
package has to be kept and handled
Catalogue number:
To indicate the catalogue number for this
system
To indicate the manufacturer
Product Technical Information
$POUBJOT4VĂłDJFOUGPSO5FTUT
To use for 6 months after first opening the
container.
DO NOT REUSE:
To warn the user of a piece of
equipment that it is for single use
only and that it must not therefore be used
more than once
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Annex 3 : References
1.
2.
Product Technical Information
3.
American Diabetes Association, Clinical Practice
Recommendation Guidelines 2003, Diabetes care, Vol.
26. Supplement 1. p.22
Stedman, TL. Stedman’s Medical Dictionary, 27th
Edition, 1999, p. 2082.
Ellen T. Chen, James H. Nichols, Show-Hong Duh, Glen
Hortin, MD: Diabetes Technology & Therapeutics,
Performance Evaluation of Blood Glucose Monitoring
Devices, Oct 2003, Vol. 5, No. 5 : 749 -768
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Return
You must contact SD Biosensor Customer Service at +8231-300-0400 before returning your meter. You will be
instructed how to return the meter to SD Biosensor, Inc.
Returned meters without this authorization will not be
accepted.
Product Technical Information
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1)
this device may not cause harmful interference, and (2) this
device must accept any interference received, including
interference that may cause undesired operation.
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Manufactured by
SD BIOSENSOR, Inc.
C-4th&5th Floor Digital Empire Building 980-3,
Yeongtong-dong, Yeongtong-gu, Suwon-si,
Kyonggi-do, Korea
Product Technical Information
EC-Representative
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SD GlucoNaviiÂŽ Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM
Product Technical Information
MEMO
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