iSens AutoChek t User manual

i-SENS, Inc.
465-6 Wolgye4-dong, Nowon-gu
Seoul 139-845, Korea
www.i-sens.com
Medical Technology Promedt
Consulting GmbH,
Altenhofstrasse 80,D-66386
St. Ingbert, Germany
ⓒ2012 i-SENS, Inc. All Rights Reserved. PGA1E3121 REVx 05/2012 0123

Owner’s Booklet
Blood Glucose Monitoring System
Data Transmission

Welcome to the AutoChek t BGMS
Blood Glucose Monitoring System
Thank you for purchasing the AutoChek t Blood Glucose Monitoring System.
The system provides you with safe, convenient, and painless blood glucose in vitro
(i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just
5 seconds with a small (0.5 ㎕) blood sample.
The AutoChek t Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn from the
fingertips and alternative sites such as the forearm, palm, thigh, and calf.
The AutoChek t Blood Glucose Monitoring System is intended for self testing
outside the body (in vitro) by people with diabetes at home as an aid to monitor the
effectiveness of diabetes control.
The AutoChek t is capable of sending test results to AutoChek t’s remote database
by using cellular data transmission. AutoChek t securely uploads and manages
blood glucose readings, eliminating the need to maintain personal logbooks.

Table of Contents
Important Information : Read This First! -------------------------------------- 6
Important Information----------------------------------------------------------- 7
Specifications ------------------------------------------------------------------- 8
AutoChek t Blood Glucose Monitoring System ------------------------------ 9
AutoChek t Blood Glucose Test Strip --------------------------------------- 10
AutoChek t Blood Glucose Meter -------------------------------------------- 12
AutoChek t Blood Glucose Meter -------------------------------------------- 13
AutoChek t Blood Glucose Meter Display ---------------------------------- 14
Adjusting the Date, Time and Unit ------------------------------------------- 15
Setting up Your System ------------------------------------------------------- 15
Setting the Sound On/Off ---------------------------------------------------- 19
Setting the Cellular function On/Off ----------------------------------------- 20
Setting the ‘Test Result Reset’ ----------------------------------------------- 23
Checking the System --------------------------------------------------------- 24
Comparing the Control Solution Test Results ------------------------------ 27
Using the Lancing Device ---------------------------------------------------- 28
Preparing the Lancing Device for Blood Sample Retrieval --------------- 29
Preparing the Meter and Test strip ------------------------------------------ 31
Applying Blood Sample ------------------------------------------------------ 32
Information
Preparation
Testing

Result Data Transmission I--------------------------------------------------- 34
Result Data Transmission II -------------------------------------------------- 35
Automatic time adjusting ----------------------------------------------------- 37
Discarding Used Lancets ----------------------------------------------------- 38
Alternative Site Testing ------------------------------------------------------- 39
HI and Lo Message ------------------------------------------------------------ 42
Target Blood Glucose Ranges ----------------------------------------------- 43
Meter Memory ----------------------------------------------------------------- 44
Setting the post-meal alarm (PP2 alarm) ------------------------------------ 46
Setting the Alarm Function --------------------------------------------------- 46
Setting the Time Alarms (alarm 1~3) ---------------------------------------- 48
Charging Your AutoChek t Blood Glucose Meter -------------------------- 50
Caring for Your System ------------------------------------------------------- 52
Understanding Error and Other Message ----------------------------------- 52
General Troubleshooting ----------------------------------------------------- 52
Understanding Error and other Message ----------------------------------- 53
Performance Characterstic --------------------------------------------------- 58
Warranty Information --------------------------------------------------------- 60
Additional function
Maintenance

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To receive safe and optimum system benefits, please read the entire manual
contents before the system.
Please note the following instructions:
• Do not use the system for the diagnosis of diabetes or for
testing newborns.
• Use only fresh capillary whole blood samples for testing.
• Alterative site and fingertip test result may differ significantly due
to rapid change in the glucose level post meal, insulin injection, or
exercise.
The following chart explains the symbols you’ll find in the AutoChek t User Manual,
product packaging, and product inserts.
For
in vitro diagnostic use
This product fulfills the requirements for Directive 98/79/EC
0123
In
vitro diagnostic medical devices
Cautions for safety and optimum product use
Consult instruction for use
Manufacturer Serial number
Authorized representative
Do not reuse
Temperature limitations Batch code
Use by (unopened or opened test strip container)
Do not discard this product with other household-type waste
Important Information : Read This First!

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· The AutoChek t blood glucose monitoring system is intended for self-
testing outside the body (in vitro diagnostic use).
· The glucose in the blood sample mixes with special chemicals on the
test strip where to produce a small electrical current. The AutoChek t
meter detects this electrical current and measures the amount of
glucose in the blood sample.
· The AutoChek t blood glucose meter is designed to minimize code related
errors in monitoring by using the no-coding function.
· The AutoChek t blood glucose meter should be used only with the
AutoChek t strip.
· Do not use the system for testing newborns or pregnant women
because test results may be affected by the red blood cell count
(hematocrit).
· Very high (60% or more) or very low (20% or less) hematocrit can lead
to incorrect test results.
· A glucose value of less than 3.9 mmol/L may indicate hypoglycemia and a value
of more than 13.3 mmol/L may indicate hyperglycemia.
If you need assistance, please contact your authorized i-SENS sales
representative or visit www.i-sens.com for more information.
Important Information

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• Product specifications
Reported result range 20 ~ 600 mg/dL(1.1 ~ 33.3 mmol/L)
Sample size Minimum 0.5 ㎕
Test time 5 seconds
Sample type Fresh capillary whole blood
Calibration Plasma-equivalent
Assay method Electrochemical
Power 3.7V Lithium – Polymer Battery
(Rechargeable Type)
Memory 250 test result
Size 45L x 96.9W x 18H (mm)
Weight 66.1g
• Operating ranges
Temperature 10~40°C(50 ~ 104 °F)
Relativity humidity 10 ~ 90%
Hematocrit 20 ~ 60%
Specifications

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•Components
• Certain components may not be included depending on the
place of purchase
• Check all the components after opening the AutoChek t
blood glucose monitoring system package.
The exact contents are listed on the main box
• The cable for data transmission can be ordered separately.
Please contact your authorized i-SENS sales representative.
①Glucose Meter
②Lancing Device
③Lancets(10) ⑦Carrying Case
④Owner’s Booklet ⑧Test Strip
⑤Quick Reference Guide
⑥Logbook
Autochek t Blood Glucose Monitoring System

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The AutoChek t blood glucose monitoring system measures blood glucose quickly
and accurately. It automatically absorbs the small blood sample applied to the narrow
edge of the test strip.
Autochek t Blood Glucose Test Strip

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Warning!
· The AutoChek t test strip should be used only with fresh
capillary whole blood samples.
· Do not reuse test strips.
· Do not use test strips past the expiration date.
· Test strips in new, unopened containers and test strips in
containers that have been opened can be used up until the
expiration date printed on the test strip box and container
label if the test strips are used and stored according to its
storage and handling methods.
· Store test strips in a cool and dry place at a temperature
· of 1 ~ 30˚C (34 ~ 86˚F).
· Keep away test strips from direct sunlight or heat and
do not refrigerate or freeze.
· Store test strips only in their original vial.
· Close the vial tightly after removing a test strip for testing
and use the strip immediately.
· Handle test strips only with clean and dry hands.
· Do not bend, cut, or alter test strips in any way.
· For detailed storage and usage information, refer to
the AutoChek t test strip package insert.
Caution:
Keep the meter testing supplies away from young children.

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Display
Shows results
and messages
▲▼ Buttons
Select or changes
information
SButton
Turns the meter
on/off and
confirms menu
selections
Test Strip Port
Insert test strip here
Autochek t Blood Glucose Meter

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SIM Card Slot
Insert a Mobile
SIM Card
Communication port
Charging the
Battery or Used to
transfer data from the
meter to a computer a
Mini USB Cable
Autochek t Blood Glucose Meter
Note:
The mini USB cable for data transmission to PC can be ordered
Separately, Please contact your authorized i-SENS sales representative.

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mem
Appears when test
result stored in the
memory are displayed
Sound icon
Appears only when
the sound is set to
OFF
alarm
Appears when the
time alarm has been
set
check
Appears when test
result have not been
saved
mmol/L
Unit for measuring
blood glucose
Battery icon
Battery level indicator
Post-meal test flag
Appears during post-
Meal testing and
When post-meal test
Result are displayed
Test result
Test results
displaying panel
Decimal point
Appears when the
blood glucose
measuring unit is set
to mmol/L
mg/dL
Unit for measuring
blood glucose
Blood insertion icon
Unit for measuring
blood glucose
Autochek t Blood Glucose Meter Display
Alarm icon
Appears when the post
-meal alarm has been
set

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Press and hold the Sbutton for 3 seconds to turnon the meter. After all settings
are finished, press and hold the Sbutton for 3 seconds to turn off the meter.
Press ▲ or ▼to reach the accurate value. Press and hold ▼ to scroll faster
Adjusting the Date, Time and Unit
Press and hold the Sbutton for 3 seconds to
turnon the meter. After all the segments
flash across the screen, the ‘SET’ character icon
will be displayed on the screen.
Press the Sbutton again to enter the year setting mode.
Enter the SET mode and press the Sbutton until
the ‘AUT’ appears on the screen.
By pressing the Sbutton one more time,
the meter will automatically adjust itself to
the correct current time.
(refer the Automatic time adjusting)
Setting up Your System
Ste
p
1 Enterin
g
the SET Mode
Ste
p
2 Select the automatic time ad
j
ustin
g
mode

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If user didn’t select the ‘automatic time adjusting mode ‘
at the “Step 2”, The number that appears on the screen
after the meter is turned on indicates the year of
manufacture. Press and release the or
to adjust until the correct year appears.
Press and hold the button to scroll through the
numbers quickly. After setting the year,
press the Sbutton to confirm your selection and
enter the month setting mode
A number indicating the month will be
blinking on the left corner of the screen.
Press the ▲or ▼until the correct month appears.
Press the Sbutton to confirm your selection and
enter the date setting mode.
Ste
p
3 Settin
g
the Year
Ste
p
4 Settin
g
the Month

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Press the▲or ▼until the screen displays
The correct date. Press the Sbutton to
confirm the date and enter the time setting mode.
The meter can be set in AM/PM 12-hour or
24-hour clock format. Press the▲or ▼to select a
format. The AM / PM icon is not displayed in the 24-
hour format. After selecting the format press the S
button to enter the hour setting mode.
Press the ▲ or ▼ until the correct hour
appears. After the hour is set, press the S
button to enter the minute setting mode.
Ste
p
5 Settin
g
the Date
Ste
p
6 Settin
g
the Time
Ste
p
7 Settin
g
the Hour

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Press the ▲or ▼until the correct minute
appears. After setting the minute, press the S
button to enter the unit setting mode
Ste
p
8 Settin
g
the Minute

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Setting the Sound On/Off
On the sound option menu, pressing the ▲or ▼, the
screen will display the On or OFF. Press the Sbutton to
confirm the selection.
The meter will beep in the following instances,
if the meter’s sound is set to On.
• When the test strip is inserted in the meter
• When the blood sample is absorbed into the test
strip and the test starts
• When the test result is displayed
• When you push the Sbutton or ▲button to check
the memory
• When you push the ▲button to set the post-
meal (PP2) alarm
• When it is time for a preset blood glucose test
If the sound is set to OFF, none of the sound
functions will work
Note:
Only when the sound is set to OFF, icon appears on the display
Ste
p
9

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Setting the Cellular function On/Off
Enter the SET mode and press the Sbutton until
the ‘CEL’ appears on the screen. On this screen,
the cellular function of the meter can be activated
or deactivated.
From the ‘CEL’ screen, press the ▲or ▼button until
the ‘On’ character icon appears on the screen. Press
the Sbutton to turn on the cellular function of the meter.
From the ‘CEL’ screen, press the ▲or ▼button until
OFF’ appears on the screen. Press the Sbutton to turn
off the cellular function of the meter.
Ste
p
10
Ste
p
11