VPD 2in1 MICRO User manual

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

Blood glucose monitoring system
Sistem za nadzor sladkorja v krvi
Systém monitorovania glukózy v krvi

Thank you for choosing the 2in1.
MICRO System.
Please read this User’s Guide
carefully before using to ensure
correct use.
Please keep this User’s Guide for
your future reference.
EN

4
2in1. MICRO System combined with a
smart phone can be used to measure
blood glucose anywhere and anytime.
The 2in1. MICRO System uses the
operation system of your Android
smartphone and is easy and simple to
operate. Automatic coding in the 2in1.
MICRO meter provides accurate results.
The system should be used only for
testing glucose and only with fresh
capillary whole blood samples. The
system is intended for self-testing by
persons with use at home and in clinical
settings. It should not be used for the
diagnosis of diabetes or the testing of
newborns.

5
Features
1. 2in1. MICRO system is easy and
intuitive with smart phone.
2. It is very small size and stylish design
allows you to take it everywhere with
smart phone.
3. It uses the power of a smart phone.
2in1. MICRO does not need batteries.
4. The meter does not require any
settings.
5. Smart phone stores all test results
and displays information in various
useful formats. You do not have to
carry log book.
6. It requires very small volume (0.5μL)
and display the result just in 5
seconds.
7. 2in1. MICRO is approved for alternate
site testing (AST) giving more
options and less pain.

6
Table of Contents
Before Starting 7
About 2in1. MICRO System 10
Name and Funtion of the Parts 11
Cautions 14
Installing the Application 19
Obtaining Blood Drop 20
About Alternate Site Testing 25
Testing Your Blood Glucose 29
Control Solution Testing 39
Reviewing Results 48
Troubleshooting 50
Caring for System 52
Performance Characteristics 55
Specifications 57

7
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 sucient for <n> tests
Direct current
Separate disposal from
otherhousehold waste
Symbols
Before Starting
SN

Before Starting
8
Indications for Use
The 2in1. MICRO Blood Glucose
Monitoring System is intended for the
quantitative measurement of glucose
(sugar) in fresh capillary whole blood
samples drawn from the fingertips,
forearm, upperarm, hand, thigh or calf
as an aid in monitoring the eectiveness
of diabetes management in the home
by patients with diabetes. The 2in1.
MICRO Blood Glucose Monitoring
System is intended to be used by a
single patientand should not be shared
with any other person. 2in1. MICRO
System is for self testing outside the
body (in vitro diagnostic useonly) by
people with diabetes at home as an aid
to monitor the eectiveness of diabetes
control. The 2in1. MICRO Blood Glucose
Monitoring System should not be
used for the diagnosis or screening of
diabetes or for newborns.
Alternative site testing should be done

Before Starting
9
only during steady-state times (when
glucose is not changing rapidly).
Test Principle
The 2in1. MICRO Blood Glucose
Monitoring System is based on
measurement of a small electrical
current produced by the reaction
of glucose in the blood sample
with the reagents on the strip. This
current is changes to the amount
of glucose in the blood sample. The
glucose concentration in the sample
is calculated based on the electrical
current and displayed. The 2in1. MICRO
Blood Glucose Monitoring System is
intended to be used with the Samsung
Galaxy S2, Galaxy S3, Galaxy S4, Galaxy
Note and Galaxy Note 2.
The 2in1. MICRO Blood Glucose
Monitoring System is intended to be
used with the smartphone who have
OTG (on the go) function integrated.

10
2in1. MICRO System includes:
1. 2in1. MICRO Meter
2. Carrying Case
3. Lancing Device
4. 2in1. Blood Glucose Test Strips
5. Lancets
Documents in your system include this
USER’S GUIDE and QUICK GUIDE.If
any items are missing, call your local
distributor.
Smart phone is not included and must
be purchased separately. 2in1. MICRO
meter supports the Samsung Galaxy
S2, Galaxy S3, Galaxy S4, Galaxy Note
and Galaxy Note 2 with Android 4.0 or
higher.
* Galaxy is trademark of Samsung Electronics
Co., Ltd. and Android is trademark of Google
Inc.
About 2in1. MICRO System

11
2in1. MICRO meter
Test Strip Port
Insert the end of a 2in1.
teststrip here.
Power Indicator
If this is turned on, the
meter is ready to test.
Micro USB Plug
Insert this into USB jack
of your smart phone
for testing your blood
glucose.
Names and Functions of the Parts

Names and Functions of the Parts
12
2in1. Test Strips
Electrodes
The end of the test strip is
inserted into the test strip
port of the meter with the
end facing up.
Sample Tip
Apply the blood sample to
the end of the test strip.

Names and Functions of the Parts
13
Lancing Device
* Clear AST cap is an optional accessory.
Please contact your local distributor.
Adjustable cap
Clear AST cap*
Lancet ejector
Sliding barrel
Release
button
Lancet
holder
Important: Lancet and Lancing De-
vice are subject to change without
notice. The CE certified Lancet and
Lancing Device should be used.

14
Cautions
Cautions for System
• The 2in1. MICRO blood glucose mon-
itoring system is intended for use
outside the body (in vitro diagnostic
use only).
• The 2in1. MICRO system should be
used only for testing glucose and
only with fresh capillary whole blood
samples.
• The 2in1. MICRO system should not
be used for the diagnosis or screen-
ing of diabetes or for the testing of
newborns.
• Do not use the 2in1. MICRO system
for any purpose other than blood
glucose testing.
• Before using the 2in1. MICRO sys-
tem, read all instructions in this Us-
er’s guide and the test strip insert
found in the test strip box carefully
and practice for accurate and safe
testing.

Cautions
15
• The 2in1. MICRO meter should only
beused with 2in1. Test Strip and 2in1.
Control Solution.
• The 2in1. MICRO system contains
small parts that may be dangerous
if swallowed.
• Check the package before starting
the measurement.
• Do not make any decision of medical
relevance without first consulting
your physician and/or having
received appropriate training.

Cautions
16
Cautions for Test Strip
• Store the test strip in a cool, dry
place between 2° and 32°C (36° and
90°F).
• Keep away from direct sunlight and
heat.
• After removing test strip from the
vial, immediately close the vial cap
tightly.
• You may get the inaccurate result if
vial cap opened long period of time.
• Do not drop the blood on the surface
of test strip directly.
• Do not press the test strip against
your finger. This may cause
inaccurate aspiration of blood.
• Do not use a test strip that appears
damaged or has been used. Test
strips are for single use only.
• Store test strips in their original vial.
• After you take a test strip out of the
vial, be sure to use it within three
minutes.
• Always use test strips within 3
months (90 days) after first opening.
• With clean, dry hands, you may

Cautions
17
touch the test strip anywhere when
removing it from the vial or inserting
it into the meter.
• Do not bend, cut, or alter test strips.
Cautions for Meter
• Keep the meter out of reach of
young children. If a young child
swallows meter, immediately consult
with a doctor.
• Do not disassemble or modify the
meter.
• Do not subject the meter to severe
shock, drop or step on meter.
• The meter is not waterproof. Do not
wash it or touch it with wet hands.
• Do not wipe the meter with thinner,
or abrasive cleaners.

Cautions
18
• Avoid the meter being exposed to
high temperature, high humidity, rain
and/or dust when using or storing
the meter.
• If your meter has been exposed to
extremes in temperature, do not test
until you have kept the unit at room
temperature for at least 20 minutes.

19
The 2in1. MICRO system may only be
used with the 2in1. MICRO+application.
The 2in1. MICRO+application
is a free download from the
Play Store.
To download directly on your
smartphone, tap on the Play Store icon
andtouch the Search icon at the top of
the screen. Then type “2in1. MICRO+”
into the search bar at the top. The 2in1.
MICRO+application is a free download
from the Play Store. The 2in1. MICRO
system may only be used with the 2in1.
MICRO+application. Pick out “2in1.
MICRO+” from the list, and download
as you would any other application. You
can also download the “2in1. MICRO+”
application using Google Play.
* Play Store and Google Play are trademarks
of Google Inc.
Installing the Application

20
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.
Table of contents
Languages: