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