2in1 SMART User manual

EN
SL
SK
HU
USER’S GUIDE
NAVODILA ZA UPORABO
NÁVOD NA POUŽITIE
FELHASZNÁLÓI KÉZIKÖNYV

EN
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
reference.

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.

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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.

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Table of Contents
Before Starting 6
About 2in1. SMART System 8
Name and Funtion 9
Cautions 11
Instaling the Application 13
Obtaining Blood Drop 14
About Alternate Site Testing 17
Testing Your Blood Glucose 18
Control solution testing 23
Reviewing Results 28
Troubleshooting 30
Caring for System 31
Performance Characteristics 33
Specifications 35
Warranty 36
Technical support 37

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Symbols
Before Starting
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
Catalogue number
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 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.

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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

9
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
10
2in1. Test Strips
Electrodes
Insert the test strip into port until stop while facing up.
Sample Tip
The fresh blood sample drawn into.

11
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.
• 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 purchasing 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 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.
Cautions

Cautions
12
• 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.
• 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 abra-
sive cleaners.
• 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.

13
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
When you delete 2in1
SMART+ application from
your smart phone, the smart
phone will ask if you realy
want to delete it. This ques-
tion is a serious warning
that with pressing on button
DELETE you will cause lose
of all data associated with
this application.
The application removal message can varies depending
on your smartphone! 
By pressing the button to remove application you will cause
lose of all data.
CAUTION

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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.
STEP 3
Insert a new sterile lancet into the lancet
holder.

Obtaining Blood Drop
15
STEP 4
Twist the cap of the lancet o.
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.

Obtaining Blood Drop
16
STEP 7
Set the proper depth of penetration by
rotating the cap of lancing device. 1-2
for soft or thin skin, 3 for average skin,
4-5 for thick or calloused skin.
STEP 8
Place the lancing device on pricked site.
Hold the lancing device firmly against
the side of the finger, with the cap
resting on the finger (The harder it is
pressed the deeper the puncture). Press
the release button to take a sample.
To reduce the infection possibilities:
• Make sure to wash the puncture site with soap and water
before sampling.
• Do not share a lancet or a lancing device with others.
• Always use a new lancet - lancets are for single use only.
• Keep your meter and lancing device clean.
CAUTION

17
About Alternate Site Testing
The 2in1. SMART meter lets you obtain a blood sample from
your Upper arm, Forearm, Hand, Thigh or Calf. Obtaining a drop
of blood from these “alternate site” may be less painful than a
fingertip sample. Following figure shows the areas where you
can test with the 2in1. SMART. Avoid moles, veins, bones and
tendons. Consult to your healthcare professional before using
alternate site testing.
Upper Arm
Forearm
Hand
Fingertips
Thigh
Calf
Do not test on alternate sites:
• When you think your blood glucose level is changing
rapidly, such as within two hours of exercise, a rapidacting
insulin injection or insulin pump bolus or within two hours
after a meal.
• If you are testing for hypoglycemia (low blood glucose) or
if you suer from hypoglycemia unawareness.
CAUTION

18
Testing Your Blood Glucose
STEP 1
Execute the 2in1. SMART+application on your smart phone by
tapping icon. If there is no 2in1. SMART+application, please
install the application first. (See page 13)
STEP 2
Plug the 2in1. SMART meter into
your headphone jack. You may
see a volume control dialogue
box appears on screen. Make
sure the headphone volume
maximize for 2in1. SMART meter
getting enough power. The
white light of 2in1. SMART is on
and “Insert Strip” is displayed.

Testing Your Blood Glucose
19
STEP 3
Insert the test strip while the
electrode end facing up into
the test strip port until stops
gently. Do not push strongly.
STEP 4
“Apply Sample” tells the 2in1.
SMART is ready to test. To
marking as a control solution
result, slide the bar at the
bottom of the screen.