VPD 2 in 1 Smart User manual

EN
SK
USER’S GUIDE
NÁVOD NA POUŽITIE
BLOOD GLUCOSE MONITORING SYSTEM
SYSTÉM MONITOROVANIA GLUKÓZY VKRVI

Thank you for your purchasing the
2in1. SMART System.
Please read this User’s Guide
thoroughly before using to ensure
correct operation.
Please keep this User’s Guide in
safe place for your future refer-
ence.
EN

3
The 2in1. SMART combined with a Smart
Phone, can be used to measuring your
blood glucose level whenever you need.
The 2in1. SMART uses the operating
system of your Smart Phone and is very
easy and simple to operate. Automatic
coding by the 2in1. SMART provides
accurate results. The 2in1. SMART is
only used for testing glucose level and
using only fresh capillary whole blood
sample. The 2in1. SMART is intended
for use outside the body (diagnostic
use) by people diabetes at home and
by healthcare professional in clinical
setting. The 2in1. SMART should not
be used for the diagnosis of diabetes
without the guidance of a healthcare
professional or the testing of newborns.

4
Features
1. The 2in1. SMART system is easy and
intuitive with smart phone.
2. The small size with stylish design
and easie operation is always with
you wherever you go.
3. The 2in1. SMART uses the power of
smart phone. The 2in1. SMART is no
need battery.
4. The 2in1. SMART does not require
any settings.
5. Smart phone stores all test results
and displays information in various
useful formats. No need to carrying
the log book.
6. Requires very small volume (0.5
μL) and display the result within 5
seconds.

5
Table of Contents
Before Starting 6
About 2in1. SMART System 9
Name and Funtion 10
Cautions 12
Instaling the Application 17
Obtaining Blood Drop 18
About Alternate Site Testing 23
Testing Your Blood Glucose 25
Control solution testing 35
Reviewing Results 44
Troubleshooting 47
Caring for System 49
Performance Characteristics 52
Specifications 54
Warranty 56
Technical support 57

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Caution, see instructions for use
Single use only
Expiration date
Serial number
Lot number
In Vitro Diagnostic medical device
Manufacturer
Authorised representative
Symbol for temperature limitation
Consult instructions for use
Biological risks
Contains sucient for <n> tests
Direct current
Separate disposal from
otherhousehold waste
Symbols
Before Starting
SN

Before Starting
7
Indications for Use
The 2in1. SMART Blood Glucose
Monitoring System is intended for the
quantitative measurement of glucose
(sugar) in fresh capillary whole blood
samples drawn from the fingertips,
forearm, upper arm, hand, thigh or calf
as an aid in monitoring the eectiveness
of diabetes management at home by
patients with diabetes. The 2in1. SMART
Blood Glucose Monitoring System is
intended to be used by a single patient
and should not be shared with any other
person. 2in1. SMART System is for self-
testing outside the body (diagnostic
use) by people with diabetes at home
as an aid to monitoring for the eective
of diabetes control. The 2in1. SMART
Blood Glucose Monitoring System
should not be used for the diagnosis
or screening of diabetes without the
guidance of a healthcare professional
or for testing newborns. Alternative
site testing should be done only during
steady-state (when glucose level is not

Before Starting
8
changing rapidly).
The 2in1. SMART Blood Glucose
Monitoring System is intended to be
used by the Apple iPhone 3GS, iPhone
4, iPhone 4S, iPod touch 4th generation,
iPad and iPad 2.
Test Principle
The 2in1. SMART System is based
on detection of a small electrical
current variation, which produced by
the reaction of glucose in the blood
sample with the reagents on the strip.
This current is varied by the amount
of glucose in the blood sample. The
current variation is calculated to
glucose concentration of sample.

9
2in1. SMART System includes:
1. 2in1. SMART Meter
2. Carrying Case
3. Lancing Device
4. 2in1. Blood Glucose Test Strips
5. Lancets
Document in your system include this
USER’S GUIDE. If any items are missing,
call your local distributor.
Smart phone not included, and must
be purchased separately. 2in1. SMART
System supports the Apple iPhone 3GS,
iPhone 4, iPhone 4S, iPod touch 4th
generation, iPad and iPad 2 (iOS 5.0).
* iPad, iPhone and iPod touch are trademarks
of Apple Inc., registered in the U.S. and other
countries.
About 2in1. SMART System

10
2in1. SMART meter
Test Strip Port
Insert the end of a 2in1.
teststrip here.
Power Indicator
Turn on when the meter
is ready to test.
Phone Plug
Insert into your smart
phone ear phone jack.
Names and Functions

Names and Functions
11
2in1. Test Strips
Electrodes
Insert the test strip into port
until stop while facing up.
Sample Tip
The fresh blood sample
drawn into.

12
Cautions for System
• The 2in1. SMART is intended for use
outside the body (in vitro diagnostic
use).
• The 2in1. SMART is only use fresh
capillary whole blood samples.
• Do not use the 2in1. SMART system
for the diagnosis, screening of
diabetes without the guidance of a
healthcare professional or for the
testing of newborns.
• Do not use the 2in1. SMART other
than blood glucose test.
• Before using the 2in1. SMART,
read all instructions in this User’s
Guide and Insert Paper of the test
strip carefully, and do practice for
accurate and safe use.
Cautions

Cautions
13
• The 2in1. SMART meter must use
with 2in1. Test Strip and 2in1. Control
Solution.
• The 2in1. SMART system contains
small parts that may be dangerous
if swallowed.
• Check the packages when purchas-
ing and before using the 2in1. SMART
system.
• Do not make any medical relevance
decision without consulting your
physician and/or having received
appropriate training.

Cautions
14
Cautions for Test Strip
• Store test strip in a cool, dry place
between 2°C ~ 32°C (36°F ~ 90°F).
• Keep away from direct sunlight and
heat.
• After taking a test strip out of the vial,
close cap tightly and immediately.
• You may get inaccurate result if vial
cap remains opened long time.
• Don’t drop the blood sample on the
surface of test strip directly.
• Do not press test strip against your
finger. It may aect bad aspiration of
blood sample.
• Do not use a test strip that looks
damaged and/or used. Test strips
are for single use only.
• Store the test strips in their original
vial.
• After you take a strip out of the vial,
be sure to use it within three minutes.

Cautions
15
• Use test strips within 3 months (90
days) after opening the vial cap.
• By clean and dry hands, you may
touch when taking out test strip
and/or insert to port.
• Do not bend, cut, or modify test
strips.
Cautions for Meter
• Keep the 2in1. SMART out of
children’s reach. If a children
swallows meter accidentally, consult
with a doctor immediately.
• Do not disassemble or modify the
meter.
• Do not attempt to severe shock,
drop or step on 2in1. SMART.
• The 2in1. SMART is not waterproof.
Do not wash with water or touch by
wet hands.
• Do not wipe the 2in1. SMART with
Chemical solvents, or abrasive clean-
ers.

Cautions
16
• Avoid the 2in1. SMART being
exposed to high temperature, high
humidity, rain and/or dust when
using or storing.
• When your 2in1. SMART has been
exposed to extreme temperature, do
not test until the 2in1. SMART reach
to room temperature for 20 minutes
at least.

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The 2in1. SMART system can work by
the 2in1. SMART application.
The 2in1. SMART application is free of
download from the App Store.
To download directly on your smart
phone, tap on the App Store icon and
select the Search tab at the bottom of
the screen. Then type “2in1 SMART”
into the search bar at the top.
Select “2in1 SMART” from the list, and
install as any other applications.
You can also download the “2in1
SMART” application using iTunes.
Installing the Application

18
Obtaining Blood Drop
STEP 1
Wash your hands carefully with warm
water to increase the circulation of
the blood into the fingers. Dry hands
thoroughly until the finger to be pricked
is completely dry.
STEP 2
Unscrew the cap
of the lancing
device by turning
it counter-
clockwise while
holding the base
firmly.

Obtaining Blood Drop
19
STEP 3
Insert a new sterile lancet into the lan-
cet holder.
STEP 4
Twist the cap of the lancet o.

Obtaining Blood Drop
20
STEP 5
Put the cap of the lancing device back
on and turn it clockwise.
STEP 6
Hold the lancing device firmly and pull
back the sliding barrel.Now the lancing
device is cocked.