2in1 MICRO User manual

ENG
USER’S GUIDE
Blood glucose monitoring system

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.

4 5
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.
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.

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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
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 StartingBefore Starting
8 9
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
eectiveness 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
eectiveness 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
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.

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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.
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.
About 2in1. MICRO System Names and Functions of the Parts

Names and Functions of the PartsNames and Functions of the Parts
12 13
2in1. Test Strips Lancing Device
Electrodes
The end of the test strip is
inserted into the test strip
port of the meter with the
end facing up. * Clear AST cap is an optional accessory.
Please contact your local distributor.
Sample Tip
Apply the blood sample to
the end of the test strip.
Adjustable cap
Clear AST cap
Lancet ejector
Sliding barrel
Release
button
Important: Lancet and Lancing De-
vice are subject to change without
notice. The CE certified Lancet and
Lancing Device should be used.

Cautions
14 15
Cautions
Cautions for System
• The 2in1. MICRO blood glucose
monitoring 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
screening 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
system, read all instructions in this
User’s guide and the test strip insert
found in the test strip box carefully
and practice for accurate and safe
testing.
• 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.

CautionsCautions
16 17
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
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.

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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.
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 ofthe 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

Obtaining Blood Drop
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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 3
While holding the lancet carrier, insert
a new sterile lancet into the bottom of
lancet carrier.
STEP 4
Twist the cap of the lancet o.
STEP 2
Unscrew the cap
of the lancing
device by turning
it counter-
clockwise while
holding the base
firmly.

Obtaining Blood DropObtaining Blood Drop
22 23
STEP 5
Put the cap of the lancing device back
on and turn it clockwise.
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 in place. 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.
STEP 6
Hold the tip firmly in one hand then
pull out the sliding barrel with the
other hand. This will cock the lancing
device.

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Obtaining Blood Drop
24
To reduce the chance of infection:
• Make sure to wash the puncture
site with soap and water before
sampling.
• Do not share a lancet or a lancing
device with anyone.
• Always use a new lancet - lancets
are for single use only.
• Keep your meter and lancing
device clean.
CAUTION
About Alternate Site Testing
The 2in1. MICRO 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 testing” may be
less painful than a fingertip sample.
Following figure shows the areas
where you can test with the 2in1.
MICRO. Avoid moles, veins, bones and
tendons. Consult to your healthcare
professional before using alternate site
testing.
Upper Arm
Forearm
Hand
Fingertips
Thigh
Calf

About Alternate Site TestingAbout Alternate Site Testing
26 27
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 Obtaining a blood sample from
alternate sites is dierent than getting
a sample from fingertips.
After inserting a new sterile lancet into
the bottom of lancet carrier, put the
clear AST cap to the lancing device.

29
About Alternate Site Testing
28
Place the lancing device on the skin
in the chosen site, press and hold the
lancing device continuously for a few
seconds, then push the release button
to take a sample. Watch through
the clear cap until a sucient blood
sample is taken. If there is not enough
blood, gently massage the area until a
sucient sample has been collected.
Testing Your Blood Glucose
STEP 1
Tap the 2in1. MICRO icon on your
smartphone to open the application.
If the 2in1. MICRO application is not
installed, install the application (See
page 19).

Testing Your Blood GlucoseTesting Your Blood Glucose
30 31
STEP 2
Plug the 2in1. MICRO meter into the
USB jack of your smart phone. The
white light will turn on showing the
meter and “Insert Strip” message and
picture will appear on the display.
STEP 3
Hold the test strip with electrode end
facing up. Insert the electrode end of
the test strip into the meter as far as it
will go using gentle pressure. Do not
force the test strip into the meter.

Testing Your Blood GlucoseTesting Your Blood Glucose
32 33
STEP 4
“Apply Sample” will appear letting you
know the meter is ready to test. To
mark the result as a control solution
result, slide the button at the bottom
of the screen.
STEP 5
Bring tip of the test strip to lightly
touch the drop of blood. Blood is
automatically pulled into the test strip.

Testing Your Blood GlucoseTesting Your Blood Glucose
34 35
The volume of blood sample must
beat least 0.5 microliter (real size
”.“).
IMPORTANT STEP 6
The application will now show
counting progress during 5 seconds.
STEP 7
Your blood glucose test result is
shown on the display screen and
automatically stored in your smart
phone.

Testing Your Blood GlucoseTesting Your Blood Glucose
36 37
• If your test is above 600 mg/
dL (33.3 mmol/L), “HIGH” will
appear on the display screen.
• If your test result is lower than 10
mg/dL (0.6 mmol/L), “LOW” will
appearon the display screen.
Used test strips
and lancets
maybe considered
biohazardous waste
in your area. Be sure
to follow your local
regulations for proper
disposal.
CAUTION CAUTION
STEP 8
You can add a note to a test result with
the way of selecting icon (pre meal,
post meal, exercise, medication and
stress) or typing custom comment.
STEP 9
Remove the used test strip and touch
”save” button to store test result.
Unexpected results
If your test result is below 50 mg/dL
(2.8 mmol/L), above 250 mg/dL (13.9
mmol/L), or you see “LOW” or “HIGH”
on the display, repeat the test. If you
have a second unusual result, call your
physician or healthcare professional
immediately.
If you continue to get unexpected
results, check your system with control
solution. See Control Solution Testing
(page 39).

39
Testing Your Blood Glucose
38
Range of expected results
Blood glucose levels will vary
dependingon food intake, medication
dosages, health, stress or exercise.
Consult your healthcare professional
for the target value that is appropriate
for you. Expected blood glucose levels
for people without diabetes and who
are not pregnant:
• Fasting: Less than 110 mg/dL
(6.0mmol/L)
• 2 hours after meals: Less than
140mg/dL (7.8 mmol/L)
Reference: International Diabetes Federation 2009.
Self-Monitoring of Blood Glucose in Non-insulin
Treated Type 2 Diabetes.
2in1. control solution contains a known
amount of glucose and is used to
check that the meter and the test
strips are working properly. Control
solution is available separately.
Do a control solution test:
• to practice the test process instead
of using blood,
• whenever you open a new vial of
test strips,
• if you suspect the meter or the test
strips are not working properly,
• if you have had repeated unexpected
blood glucose results, or
• if your meter has been dropped,
exposed to liquid or is otherwise
damaged.
Testing Your Blood Glucose