iSens CareSens N Voice User manual

©2016 i-SENS, Inc. All Rights Reserved PGJ5E3056 REV1 08/2016
i-SENS, Inc.
43, Banpo-daero 28-gil,
Seocho-gu, Seoul 06646, Korea
www.i-sens.com
Australian Distributor:
Pharmaco (Australia) Ltd
Gordon, NSW 2072
Phone: [phone]
Website: www.caresens.com.au
NZ Distributor:
Pharmaco (NZ) Ltd
Auckland
Phone: 0800 GLUCOSE (0800 458267)
Website: www.caresens.co.nz

Thank you for choosing the CareSens N Voice Blood Glucose
Monitoring System. The system provides you with rapid and
convenient blood glucose in vitro (i.e., outside the body)
diagnostic monitoring. The bilingual talking function of
CareSens N Voice Meter can be used as an aid for using the
meter. The CareSens N Voice Meter is also designed to
minimise code related errors in monitoring by using the
auto coding function. You’ll receive an accurate result in five
seconds with a small 0.5 μL blood sample. This booklet
contains important information about the CareSens N Voice
Glucose Monitoring System. Please read it carefully before
testing your blood glucose.
Welcome to the CareSens N Voice
Blood Glucose Monitoring System
• No part of this document may be reproduced in any form or by any
means without the prior written consent of i-SENS.
• The information in this manual is correct at the time of printing.
However, i-SENS reserves the right to make any necessary changes at
any time without notice as our policy is one of continuous
improvement.

Information
Important Information: Read This First! 4
Specifications 6
CareSens N Voice Blood Glucose Monitoring System 7
Inserting or Replacing Batteries 8
Caring for Your System 9
CareSens N Blood Glucose Test Strip 10
CareSens N Voice Blood Glucose Meter 12
CareSens N Voice Blood Glucose Meter Display 13
Preparation
Setting Up Your System 14
Adjusting Date, Time and Sound 14
Setting the Hypoglycemia Indicator 18
Checking the System 20
Control Solution Testing 21
Comparing the Control Solution Test Results 24
Blood Glucose Testing
Using the Lancing Device 25
Preparing the Lancing Device 26
Preparing the Meter and Test Strip 28
Flagging Post-meal Test Results 29
Applying Blood Sample 30
Discarding Used Lancets 32
Alternate Site Testing 33
HI and Lo Messages 36
Target Blood Glucose Ranges 37
Transferring Test Results 38
Additional Functions
Meter Memory 39
Viewing Averages Stored in the Memory 39
Viewing Test Results 41
Setting the Alarm Function 42
Setting the Post-meal Alarm (PP2 Alarm) 42
Setting the Time Alarms (Alarm 1-3) 43
Maintenance
Understanding Error Messages 45
Other Important Messages 47
General Troubleshooting 48
Performance Characteristics 49
Warranty Information 53
Table of Contents

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Important Information: Read This First!
For optimum system benefits, please read the entire manual
contents before using the system.
Intended use:
CareSens N Voice Blood Glucose Monitoring System is used
for the quantitative measurement of the glucose level
in capillary whole blood as an aid in managing diabetes
effectively at home or in clinical settings. CareSens N Voice
Blood Glucose Monitoring System should be used only for
self-testing outside the body (in vitro diagnostic use only).
CareSens N Voice Blood Glucose Monitoring System should
not be used for the diagnosis of diabetes or for testing
newborns. Testing sites include the traditional fingertip
testing along with alternate site testing on forearm and palm.
• Glucoseinbloodsamplesreactswiththechemicalinthe
test strip to produce a small electrical current. The CareSens
N Voice Meter detects this electrical current and measures
the amount of glucose in the blood sample.
• TheCareSensNVoiceBloodGlucoseMeterisdesignedto
minimise code related errors in monitoring by using the
auto-coding function.
• TheCareSensNVoiceBloodGlucoseMetershouldbeused
only with the CareSens N Test Strips.
• Anabnormallyhighorlowredbloodcellcount(hematocrit
level over 65% or below 15%) may produce inaccurate
results.
• Ifyourtestresultisbelow3.3mmol/Lorabove13.3mmol/L,
consult a healthcare professional immediately.
• 
Inaccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate low results
may occur for individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis. Critically ill
patients should not be tested with blood glucose meters.
•  Inaccurate results may occur in patients undergoing
oxygen therapy.
If you need assistance, please contact your authorised i-SENS
sales representative or visit www.i-sens.com for more information.
For in vitro diagnostic use
ThisproductfulfillstherequirementsforDirective98/79/EC
on in vitro diagnostic medical devices
Cautions for safety and optimum product use
Use by (unopened or opened test strip vial)
Do not discard this product with other household-type
waste
Do not reuse Batch code
Consult instructions for use Manufacturer
Temperature limitation Serial number
Meaning of Symbols Used:

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Specifications CareSens N Voice Blood Glucose Monitoring System
Product specifications
Operating ranges
Measurement range  1.1-33.3mmol/L
Sample size Minimum 0.5 μL
Test time 5 seconds
Sample type Fresh capillary whole blood
Calibration Plasma-equivalent
Assay method Electrochemical
Battery life 1,000 tests
Power Two alkaline AAA batteries
Memory 500 test results
Size 100 x 56 x 19 (mm)
Weight 70 g (with batteries)
Temperature 5-50˚C
Relative humidity 10-90%
Hematocrit 15-65% • CheckallthecomponentsafteropeningtheCareSensN
Voice Blood Glucose Monitoring System package. The exact
contents are listed on the main box.
• Thecablefordatamanagementsoftwarecanbeordered
separately. Please contact your authorised i-SENS sales
representative.
04
05
06
07
08
09 03
01
02
10
Components
CareSens N Voice Blood Glucose Meter
CareLance (Lancing Device)
Lancets (50)
Owner’s Booklet
Quick Reference Guide
Logbook
01
02
03
04
05
06
Registration Card
Carrying Case
CareSens N Blood Glucose
Test Strips (10)
Batteries (2)
07
08
09
10