2in1 step User manual

Blood glucose
monitoring system
for self testing use
SELF-TESTING IVD
ENG
USER GUIDE
Thank you for purchasing the
2in1. STEP.
Please read this User Guide carefully
before using to ensure correct use.
Please keep this User’s Guide for your
future reference.
“ * “ indicates “Available only in
2in1. STEP“.

2in1. STEP system is very easy to carry around and able to be used
for measuring the glucose level in whole blood and steps* anytime.
It is also very simple, easy and foolproof. You don’t have to worry
about coding your meter because the 2in1. STEP meter does it
automatically. 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 in the home and in
clinical settings. It should not be used for the diagnosis of diabetes
or the testing of newborn.
Features 1
2
3
4
5
6
2in1. STEP has only one button to
navigate all functions easily with simple
operation.
It is small size, stylish design, and ease of
use allows you to take it everywhere.
It can show all information variously.
It requires very small volume (0.5uL) and
display the result in 5 seconds.
It can measure glucose in whole blood at
AST (Alternate site testing).
It can measure glucose concentration
when the test strip inserted without
changing the code number or using the
code chip.

Content of 2in1. STEP
Before Starting
Name and Function of the Parts
Cautions
About the STEP meter*
Obtaining Blood Drop
About Alternate Site Testing
Testing Your Blood Glucose
Control Solution Testing
Reviewing Results
Setting the Meter
Replacing the Battery
Error Messages
Troubleshooting
Performance Characteristics
System Care and Maintenance
Specifications
48
49
51
54
57
59
62
64
68
71
74
77
78
80
81
83
85
*Available only in 2in1. STEP.
Table of Contents

4
CONTENT of
2in1. STEP
2in1. STEP system includes:
1. 2in1. STEP meter 1 pcs
2. Carrying Case 1 pcs
3. Lancing Device 1 pcs
4. Lithium Battery (CR2032) 1 pcs
5. Neck Strap (Available only with 2in1. STEP) 1 pcs
6. 2in1. STEP Blood glucose test strips 10 pcs
7. Lancets 10 pcs
The address and related CE marks of lancets manufacturer and
the address of lancing device manufacturer are mentioned on the
outside box of starter kit packaging. Lancets and lancing device
are covered by Medical Device Directive (MDD).
Documents in your system include USER GUIDE and QUICK GUIDE.

5
Before Starting
Symbols:
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 sufficient for <n> tests
Direct current
Separate disposal from other household waste

6
Before Starting
Intended Use
2in1. STEP system is intended for self-testing to monitor glucose
concentrations in fresh whole blood. 2in1. STEP system is for use
outside body (in vitro diagnostic use) in fingertips, forearm, upper
arm, hand, thigh and calf testing.
Test principle
The 2in1. STEP 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 changes with the
amount of glucose in the blood sample. The glucose concentration
in the sample is calculated based on the electrical current and
displayed on the meter.
Setting the time and date
Your 2in1. STEP meter comes preset time, date, year and measure
unit. Before using your meter for the first time or if you change the
meter battery, you should check and set the time and date. If you
do not set your meter for the first time or after changing the battery,
you can hear 3 beeps when inserting the test strip.
See page 30 (Setting the Meter) to ensure your desired settings
are saved.

7
Names and Functions
of the Parts
Display Screen
This is where you read your test results,
steps and other informations.
M-button
The ‘M’ button is used to recall the
stored results and adjust the
parameters in set-up mode. You can
turn the meter off by pressing and
holding the ‘M’ button for 3 seconds.
Test Strip Port
Insert the end of a 2in1. STEP test strip
here. The meter will turn on when you
insert the test strip.
Silver Electrodes
The end of the test strip is inserted into
the test strip port of the meter with the
silver end facing up.
Sample Tip
The end of the test strip where the
blood sample is drawn into.
Front View
2in1. Test Strip

8
Names and Functions of the Parts
Strap Hole
It is for hand-strap or neck-strap.
Battery Cover
Slide cover off to
replace batteries.
SET Button
Used to enter the setup
mode for changing
the date and time and
unit of measure.
Side View
Back View

9
Names and Functions of the Parts
Clear AST cap
* available separately
Lancet ejector Sliding barre
l
Adjustable cap Lancet holder Release button
Display
Lancing Device
Displays the mode of meter.
Warns when the battery is low or must
be replaced.
Display test results, steps*, measuring
status, error messages and other
informations.
Results are displayed along with the
units of measure.

10
Cautions
The 2in1. STEP System is intended for
use outside the body (in vitro diagnostic
use) only.
The 2in1. STEP System is used only for
measuring fresh capillary whole blood.
The 2in1. STEP meter should only be
used with 2in1. STEP Test Strip and 2in1.
STEP Control Solution.
Do not use the 2in1. STEP System for
the diagnosis of diabetes, testing on
newborns and testing of arterial blood.
The 2in1. STEP System contains
small parts that may be dangerous if
swallowed.
Check the package before starting the
measurement.
Be sure to read user guide and the test
strip insert found in the test strip box
carefully before testing.
Do not make any decision of medical
relevance without first consulting your
physician and/or having recieved
appropriate training.
Cautions for
System

11
Cautions
Keep the meter out of reach of children.
If a child swallows battery, battery cover,
immediately consult with a doctor.
Do not swing the meter by holding the
neckstrap. You may injure yourself or
other people.
Do not throw the battery into fire.
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.
Avoid the meter being exposed to high
temperature, high humidity, rain and/or
dust when using or storing the meter.
Do not test glucose instantly when the
meter is moved to a place with a great
difference in temperature. Wait 20
minutes and start testing.
Cautions for
Meter

12
Cautions
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 an inaccurate 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 affect 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
Test Strip

13
*Available only with 2in1. STEP
About the STEP meter*
The 2in1. STEP System is your walking partner, along with built-in
STEP meter and can help you control your diabetes by counting
your steps and testing your blood glucose level.
We recommend that you place the meter in the upper front pocket
of your jacket, in a bag you hold tightly, or wear the meter with neck
strap around your neck.
Place the meter in your pocket
Do not place the meter in the back pocket of your pants.
Place the meter in the pocket you hold tightly.
Place the meter in your bag
Place the meter in your pocket or the partition of your bag.
Wear the meter with neck strap around your neck
Use the supplied neck strap and place the meter near your chest.
Important:
The meter can count steps only in the following cases:
When the meter is off with battery installed.
‘M’ button is pressed and released when the meter
is off.

14
About the STEP meter
When the memory is being displayed, the
blood glucose is being tested or the meter
is being set.
When the front of the meter is placed in the
angle of less than 60° or horizontally to the
ground.
When the meter is placed in the bag that
moves irregularly because it hits your foot,
your belt or the top of your pants.
When the unit hangs from your belt, the top
of your pants or a bag.
When you walk at an inconsistent pace.
When you use the meter in the place where
lots of up and down movements or vibrations
take place.
When you walk extremely slowly.
The meter may not be able to count the steps correctly in the
following cases.

15
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

16
Obtaining Blood Drop
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 off.
STEP 5
Put the cap of the lancing device back on
and turn it clockwise.
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.

17
Obtaining Blood Drop
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.
Caution: 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.

18
About Alternate
Site Testing
The 2in1. STEP 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.
STEP System. Avoid moles, veins, bones and tendons. Consult to
your healthcare professional before using alternate site testing.
Upper Arm
Forearm
Hand
Fingertips
Thigh
Calf

19
Obtaining a blood sample from alternate sites is different 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.
Place the lancing device on the skin at 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 sufficient
blood sample is taken. If there is not enough
blood, gently massage the area until a
sufficient sample has been collected.
About Alternate Site Testing
Caution: Do not test on alternate sites:
When you think your blood glucose level is changing
rapidly, such as within two hours of exercise, a rapid-
acting 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 suffer from hypoglycemia unawareness.

20
Testing Your
Blood Glucose
STEP 1
Hold the test strip with the silver end facing
up. Insert the silver end into the test strip
port on the meter. Insert a new test strip into
the meter until it stops. The meter will turn
on.
STEP 2
Time will be displayed for a moment. Then
Code number and strip symbol will be
displayed. A strip symbol with filling blood
will appear letting you know the meter is
ready to test.
STEP 3
Make sure the code number showed on the
screen is the same as the code number
printed in the test strip vial. If the code
number on the screen is different from the
code number printed on the strip vial, try to
insert new strip.