SD Biosensor SD GlucoNavii Voice N User manual

Voice N
Voice N

I
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Dear SD GlucoNavii® Voice N System Owner;
Thank you for choosing SD GlucoNavii® Voice N Blood Glucose
Monitoring System. Your new SD GlucoNavii® Voice N 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® Voice N 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® Voice N Blood
Glucose Monitoring System
6. SD GlucoNavii® Voice N Meter
7. SD GlucoNavii® Voice N Test Strips
8. SD GlucoNavii® Voice N Accessories
9. Changing the Battery
10. Meter Set up
11. Using SD GlucoNavii® Voice N Test Strips
Chapter 2 : Control Solution Test
1. Performing a Control Solution Test
2. Troubleshooting Control Solution Test
Chapter 3 : Testing Your Blood Sugar
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
28
TABLE OF CONTENTS
30
31
34
36
36
38
40

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SD GlucoNavii® Voice N 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
42
42
42
43
44
45
47
48
52
53
53
54
55
56
57
63
65
65
67
68
70

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SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
CHAPTER 1 :
Understanding Your New System
The SD GlucoNavii® Voice N 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® Voice N test strips. Other test
strips will give inaccurate results or E-1 error message.
tDo not use the SD GlucoNavii® Voice N 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® Voice N system has been found to be
accurate at altitudes up to 11,549 feet. (3,520 meters)

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SD GlucoNavii® Voice N 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 30 - 35. 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® Voice N 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® Voice N meter and accessories
work together to measure the amount of glucose (sugar)
in your blood.
Your SD GlucoNavii® Voice N 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® Voice N blood glucose monitoring
system is suitable for self-testing.
4. Product Description and the Principle of the use
SD GlucoNavii® Voice N test strip is designed with an
electrode that measures glucose levels. Glucose in the

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SD GlucoNavii® Voice N 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® Voice N 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® Voice N test strip, the strip’s reaction chamber
automatically draws the blood into the strip through
capillary action. When the chamber is full, SD GlucoNavii®
Voice N 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® Voice N BGMS
The system includes:
tSD GlucoNavii® Voice N Meter
tSD GlucoNavii® Voice N 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
Display
Shows blood glucose
result, messages, and
glucose result stored in
memory.
Voice N
6. SD GlucoNavii® Voice N 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
Indicates
Measurement time
Indicates during the meter
setting
Indicates sound
level
Warns when the batteries
are 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 Voice N
message
Display

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SD GlucoNavii® Voice N 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
Indicates time
setting
Indicates voice
language setting

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SD GlucoNavii® Voice N 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. When
the test strip icon is ash at any setting stage, it can be strip
stand-by mode.
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.
L/R
button
L/R
button
Turn on

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

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SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
SD GlucoNavii® control solution
SD Voice N Reader/Writer
8. SD GlucoNavii® Voice N 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
9. Changing the Battery
Inserting and replacing the Battery
Your meter is shipped with two 1.5V AA alkaline batteries
that needs to be inserted before testing. The batteries that
come with your meter can be found in the mesh pocket
of your carrying case. Batteries' life will vary depending on
usage, so always keep a spare on hand. The meter saves
batteries' 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
STEP-2: Insert the 1.5V AA alkaline batteries into the
compartment correctly with respect to their polarity
(follow the directions on the case).
STEP-3: Snap battery cover back in place.
STEP-4: Push the ON/OFF button or insert a strip to start
testing.
1.5V AA
1.5V AA
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® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
10. Meter Set up
STEP-1 : Setting the sound level
1. In strip stand-by mode with sound icon, if you press
the ON/OFF button, the display for setting the sound
level will be appeared.
Set the sound level by pressing the left or right button.
Right
button
ON/OFF
button
Left
button
L/R
button
L/R
button
L/R
button
L/R
button

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SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
STEP-2: Setting the Hypo warning
tIn strip stand-by mode with set icon, if you
press the ON/OFF button, the display for
setting the hypo warning will be appeared.
tSet the OFF or 60/70/80 mg/dL by pressing
the left or right button.
NOTE
ON/OFF
button
Right
button
Left
button
L/R
button
L/R
button
L/R
button
L/R
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® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
STEP3: Setting the date and time
[ Date Setting ]
1. In strip stand-by mode with hypo set icon, if you press
the right button, the display for setting the date & time
will be appeared. And when you press the ON/OFF
button, year digit will be appeared. Set the correct year
by pressing the left or right button and then go to time
setting by pressing the ON/OFF button.
ON/OFF
button
ON/OFF
button
Right
button
Left
button
Right
button

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SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
Understanding Your New System
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.
[ON/OFF
button]
[Left or right
button]