SD Biosensor SD GlucoNavii NFC User manual

Blood Glucose
Mobile Monitoring
System
Bl
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Gl
u
M
ucose
User Instruction
Guide

I
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Dear SD GlucoNavii® NFC System Owner;
Thank you for choosing SD GlucoNavii® NFC Blood Glucose Monitoring
System. Your new SD GlucoNavii® NFC Blood Glucose Monitoring System
is an important tool that can help you better manage your diabetes.
Important steps for using the System are inside this guide. Please read it
carefully.
If you have questions, we are here to help.
Please contact SD Biosensor, Inc.
Tel : [phone]
Fax : [phone]
website : www.sdbiosensor.com
We oer 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
equipment or other
property.
To provide an additional
useful information.
Before using any product to test your blood glucose, read
all instructions and practice the test. Do all quality control
checks as directed and consult with a diabetes health
care professional. These recommendations apply to all
blood glucose monitoring systems and are supported
by the American Association of Diabetes Educators, the
American Diabetes Association, the U.S. Food and Drug
Administration, and the Advanced Medical Technology
Association.
CAUTION
NOTE
NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
TABLE OF CONTENTS
Chapter 1 : Understanding Your New System
1. Before You Start Testing
2. Special Information for Healthcare Providers and
Caregivers
3. Indication for Use
4. Product Description and the Principle of the use
5. The Complete SD GlucoNavii® NFC Blood
Glucose Monitoring System
6. SD GlucoNavii® NFC Meter
7. SD GlucoNavii® NFC Test Strips
8. SD GlucoNavii® NFC Accessories
9. Changing the Battery
10. Meter Set up
11. Using SD GlucoNavii® NFC Test Strips
Chapter 2 : Control Solution Test
1. Performing a Control Solution Test
2. Troubleshooting Control Solution Test
Chapter 3 : Testing Your Blood Glucose
1. Getting a Drop of Blood
2. Performing a Blood Glucose Test
3. Understanding Test Results
4
4
6
6
6
7
8
12
13
14
16
26
TABLE OF CONTENTS
28
29
32
34
34
36
38

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
TABLE OF CONTENTS
Chapter 4 : Using NFC function
1. Information on NFC function
2. Information on Caution for NFC
3. Using NFC function
4. How to use GlucoNaviiApp
5. How to use SD NFC Software for PC
Chapter 5 : Using the Meter Memory
1. Searching Test Results
2. Downloading results to a computer
Chapter 6 : Maintenance and Troubleshooting
1. Performing a SD Glucose check strip
2. Cleaning the meter
3. Maintenance, Testing and Transportation
4. Cleaning the Lancing Device
5. Screen Messages and Troubleshooting
6. Warnings, Precautions and Limitations
Chapter 7 : Product Technical Information
1. System Specications
Annex 1 : Information for Healthcare Professionals
Annex 2 : Symbol
Annex 3 : References
40
40
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41
42
43
45
46
50
51
51
52
53
54
55
61
63
63
65
66
68

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
CHAPTER 1 :
Understanding Your New System
The SD GlucoNavii® NFC Blood Glucose Monitoring System
1. Before You Start Testing
About the meter and test strips
t Carefully read and follow the instructions in the User
Instruction Guide and Package Inserts for the test strips
and SD GlucoNavii® control solution. It is very important
to follow the instructions in order to prevent an incorrect
result or improper treatment.
t The meter, test strips, and SD GlucoNavii® control solution
are only for use outside the body (in vitro).
t Your new meter is designed for testing fresh capillary
whole blood samples (for example, blood from your
ngertip, palm, upper arm, or forearm) or fresh venous
blood.
t Only use SD GlucoNavii® NFC test strips. Other test strips
will give inaccurate results or E-1 error message.
t Do not use the SD GlucoNavii® NFC blood glucose
monitoring system for testing of serum or plasma or
arterial blood.
t Inspect the container of test strips before using them for
the rst time. If you see any damage to the container cap
or if anything prevents the cap from closing properly, do
not use the test strips. Contact SD Biosensor, Inc. Damaged
test strips can cause inaccurate results, which could lead
to improper treatment.
About your new meter
t Set the beep, date, time, hypo warning, post-meal alarm
and alarm on your meter before you begin testing.
t SD GlucoNavii® NFC system has been found to be accurate
at altitudes up to 11,549 feet. (3,520 meters)

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
t Keep the meter and testing supplies away
from small children.
t The battery door, test strips, lancets,
protective disks, and control solution cap are
choking hazards.
t Do not eat the test strips.
t Do not swallow or inject SD GlucoNavii®
control solution, or use control solutions for
any purpose.
CAUTION
Important Information
t Dehydration: Severe dehydration resulting from exces-
sive water loss may cause false low results. If you believe
you are suering from severe dehydration, consult a
healthcare professional immediately.
t Low glucose results: If your test result is lower than 70
mg/dL or is shown as Lo, it may mean hypoglycemia(low
blood glucose). This may require immediate treatment
according to your healthcare professional’s recommenda-
tions. Although this result could be due to a test error, it is
safer to treat rst, and then repeat the test.
t High glucose results: If your test result is greater than 180
mg/dL or is shown as HI, it may mean hyperglycemia(high
blood glucose). If you do not have symptoms, rst repeat
the test. Your healthcare professional can work with you
to decide what actions, if any, you should take if you
continue to get results higher than 180 mg/dL or if you
have symptoms.
t Repeated unexpected results: If you continue to get
unexpected results, check your system with control
solution. See Checking the System with Control Solution
on pages 28 - 33. If you are experiencing symptoms that
are not consistent with your blood glucose results and
you have followed all instructions in this User Instruction

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
Guide, call your healthcare professional. Never ignore
symptoms or make signicant changes to your diabetes
control program without speaking to your healthcare
professional.
t Consult your physician to determine if it is appropriate for
your child to be taught how to use the meter system or
any other medical products.
2. Special Information for Healthcare Providers and
Caregivers
t Do not use this device to measure blood glucose in
people who are experiencing cardiovascular collapse
(severe shock) or decreased peripheral blood ow.
t Hematocrit: A hematocrit (percentage of your blood that
is red blood cells) that is higher than 70% can cause false
results.
3. Indication for use (Purpose of the devices)
Your new SD GlucoNavii® NFC meter and accessories work
together to measure the amount of glucose (sugar) in
your blood.
Your SD GlucoNavii® NFC blood glucose monitoring
system is indicated for monitoring glucose in fresh
capillary whole blood or fresh venous blood. 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 eectiveness of
diabetes control. This system should not be used for the
diagnosis of diabetes.
The SD GlucoNavii® NFC blood glucose monitoring system
is suitable for self-testing.
4. Product Description and the Principle of the use
SD GlucoNavii® NFC test strip is designed with an
electrode that measures glucose levels. Glucose in the

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
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.
SD GlucoNavii® NFC 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 SD
GlucoNavii® NFC test strip, the strip’s reaction chamber
automatically draws the blood into the strip through
capillary action. When the chamber is full, SD GlucoNavii®
NFC meter start to measure the blood glucose level. It is
a simple and practical system for the daily monitoring of
your blood glucose level.
5. The Complete GlucoNavii® NFC BGMS
The system includes:
t SD GlucoNavii® NFC Meter
t SD GlucoNavii® NFC Test strips
t SD Glucose Check strip
t 3V battery type CR2032
t User Instruction Guide
t Quick Guide
t Self-test Diary
t Test Strip Package Insert
t Carrying Case
t Lancing device
t Lancet
<Option>
t SD GlucoNavii® control solution
t SD GlucoNavii® control solution insert
t SD GlucoNavii® NFC application for Android phone
t SD NFC Software for PC
t SD NFC Reader/Writer

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
Display
Shows blood glucose
result, messages, and
glucose result stored in
memory.
NFC
6. SD GlucoNavii® NFC Meter
Arrow Buttons
Use 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.
Battery Cover
Remove cover to
change battery.
Location of NFC function
Tap a smartphone or SD NFC
R/W for communication.
Data port
Cominucate test results
with a personal computer.
(If you have software)

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
Indicates
Measurement time
Indicates during the meter
setting
Indicates beep
setting
Warns when the
battery is low or must be
replaced
Indicates if
environmental
temperature is
exceeded during
testing
Indicates post-meal or
pre-meal
Testing date
Indicates a test result stored
in memory
Unit of test result Test result and nfc
message
Display

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
Indicates the
average result Test strip
Tell you when to
apply the sample
and indicates if you
select whole blood
for blood reference
type
Indicates a control
solution test result
Indicates alarm
setting
Indicates hypo warning
Indicates S/W communication

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
1) Strip Stand-by Display
After turning on the meter, the below will be displayed
automatically to show the test strip icon ashing. In this
Strip Stand-by Display, it’s able to enter setting mode of the
meter or search the test results.
2) Blood Stand-by Display
If a test strip is inserted into the meter in either Strip Stand-
by Display or turning o, the below will be displayed
automatically to show the appropriate test result after
applying blood sample. And if you pull o the test strip,
it will return to Strip Stand-by Display. In this Blood Stand-
by Display, the ON/OFF button doesn’t act. But if you need
to check the meter or the test strip, you may use a control
solution. Then the control solution icon in the left-side of
test strip icon will be displayed by pressing left button
during 3 seconds.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
7. SD GlucoNavii® NFC Test Strip
SD GlucoNavii® NFC System measures the amount of
glucose in whole blood. Blood is applied in the Yellow
Window (TOP EDGE) of SD GlucoNavii® NFC Test Strip
and is automatically drawn into the reaction cell where
the reaction takes place.
(Top Edge)

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
SD GlucoNavii® control solution
SD NFC Reader/Writer
8. SD GlucoNavii® NFC Accessories
1
2
Lancing Device
Cap & Comfort dial with puncture depth
selection
Arming
Knob
Release
Button
Check Strip
Lancet SD Glucose check strip
Electrode
Arming
Knob

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
9. Changing the Battery
Inserting and replacing the Battery
Your meter is shipped with one 3V battery type CR2032
that needs to be inserted before testing. The battery that
comes with your meter can be found in the mesh pocket
of your carrying case. Battery life will vary depending on
usage, so always keep a spare on hand. The meter saves
battery power by automatically turning o after 1 minute
without inserting a test strip or 3 minutes with a test strip,
from non-use. If the meter does automatically shut o, all
tests in memory are saved.
STEP-1: Push the recessed plastic tab of the battery
compartment forward to ip and open the battery door.

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
STEP-2: Insert the 3V battery (type CR2032) into the
compartment with “+” side facing you.
STEP-3: Snap battery cover back in place.
STEP-4: Push the ON/OFF button or insert a strip to start
testing.
After inserting or replacing the battery, conrm
that the time and date are set correctly. If they
are not, use the ON/OFF and left/right buttons to
reset the meter before testing. See the “10 Meter
Set up”.
NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
10. 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 rst step of the setting mode.
2. Set the beep mode on or o 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 o feature, no
sound is made.
[ During 3 sec. ]
[ Left or right
button ]
[ ON/OFF
button ]

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
STEP-2: Setting the Hypo warning
1. After beep setting, the display for setting the hypo
warning will appear, the second of setting mode.
2. Set the hypo warning mode ‘o’ 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.
t 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).
t If your results are lower than selected hypo
result, the candy symbol will appear on LCD
with a ‘beep’sound. It is very important to
manage your hypoglycemia.
NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
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.
Your new meter comes with a preset time and
date. You may need to change the time to your
time zone. Having the right time and date in your
meter is important if you use the meter memory.
It also helps your healthcare team interpret your
results.
NOTE

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
[ Left or right
button ]
[ 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. Set the preferred format on the display by
pressing either the left or the right button and select by
pressing the ON/OFF button.
3. Set the correct month or day on the display by pressing
either the left or the right button and select by pressing
the ON/OFF button.