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