Voice N
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 : +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.
CAUTION
NOTE
To identify conditions
or practices that could
result in damage to
equipment or other
property.
NOTE
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.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
TABLE OF CONTENTS
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
12
13
14
16
28
Chapter 2 : Control Solution Test
1. Performing a Control Solution Test
2. Troubleshooting Control Solution Test
30
31
34
Chapter 3 : Testing Your Blood Sugar
1. Getting a Drop of Blood
2. Performing a Blood Glucose Test
3. Understanding Test Results
36
36
38
40
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
42
42
42
43
44
45
Chapter 5 : Using the Meter Memory
1. Searching Test Results
2. Downloading results to a computer
47
48
52
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
53
53
54
55
56
57
63
Chapter 7 : Product Technical Information
1. System Specifications
65
65
Annex 1 : Information for Healthcare Professionals
Annex 2 : Symbol
Annex 3 : References
67
68
70
TABLE OF CONTENTS
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
CHAPTER 1 :
Understanding Your New System
The SD GlucoNavii® Voice N Blood Glucose Monitoring System
1. Before You Start Testing
Understanding Your New System
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
fingertip, 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 first 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)
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
t
t
CAUTION
t
t
Keep the meter and testing supplies away
from small children.
The battery door, test strips, lancets,
protective disks, and control solution cap are
choking hazards.
Do not eat the test strips.
Do not swallow or inject SD GlucoNavii®
control solution, or use control solutions for
any purpose.
Understanding Your New System
Important Information
t Dehydration: Severe dehydration resulting from excessive water loss may cause false low results. If you believe
you are suffering 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 recommendations. Although this result could be due to a test error, it is
safer to treat first, 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, first 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
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM
t
Guide, call your healthcare professional. Never ignore
symptoms or make significant changes to your diabetes
control program without speaking to your healthcare
professional.
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
t
Do not use this device to measure blood glucose in
people who are experiencing cardiovascular collapse
(severe shock) or decreased peripheral blood flow.
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)
Understanding Your New System
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 effectiveness 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
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING 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
Understanding Your New System
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
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