Elektronika SensoCard Manuel utilisateur
SensoCard
SensoCard
SensoCard Plus
Blood Glucose Meter
Instructions for Use
In vitro Diagnostic Medical Device
IVD
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SensoCard
Plus
0197
CONTENTS
IMPORTANT – READ THIS BEFORE USING THE EQUIPMENT 3
INTRODUCTION 4
PACKING LIST 5
SENSOCARD METER EXPLAINED 6
UNIQUE FEATURE OF SENSOCARD PLUS 7
FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER 8
IMPORTANT PRECAUTIONS 10
TECHNICAL DATA 11
PARTS OF SENSOCARD METER 12
ABOUT TEST STRIP 13
Strip insertion and use 15
BEFORE STARTING MEASUREMENT 16
BLOOD SAMPLING 17
STRIP-CODE SETTING 18
Setting strip-code with Code-card 19
Setting strip-code manually 22
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MEASURING WITH THE METER 24
MEMORY 29
Storing data 29
Recalling data from memory 30
Average calculation 31
OVERVIEW OF FUNCTION MENUS 32
SETTING DATE AND TIME 32
PC MODE 34
SELECTING MEASUREMENT UNIT (mmol/l – mg/dl) 36
DELETING DATA STORED IN MEMORY 38
SWITCHING TO SPEAKING FUNCTION 39
BATTERY REPLACEMENT 40
MAINTENANCE 42
SENSOCARD SYSTEM CHECKING 43
Checking with Check-strip 44
Checking with CareSens control solution 46
ERROR MESSAGES AND TROUBLESHOOTING 48
MANUFACTURER'S WARRANTY 54
SYMBOLS 55
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IMPORTANT – READ THIS BEFORE USING
THE EQUIPMENT
Before testing your blood with SensoCard or SensoCard Plus Blood Glucose Monitoring
System, please read this user manual carefully.
For the safe and easy operation, studying of the Instructions For Use of the meter and
accessories (finger pricker, test strip) is necessary. Should you miss studying this manual,
you will not be familiar with the proper use of the system.
Always consult with your diabetes healthcare professional. This advice applies to all blood
glucose monitoring systems. Always use the equipment only for the purpose described in
this manual.
Never use accessories which are not supplied or recommended by the manufacturer or
distributor.
Never use the equipment if it is not working properly.
Ship and store the meter at -20 - 60°C (-4 - 140°F).
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SensoCard
INTRODUCTION
Thank you for choosing SensoCard blood glucose monitoring system. It has been carefully
designed to enable you to easily, reliably and accurately monitor your blood glucose level.
This meter meets the International Standards belong to the applicable EMC emission,
electrostatic discharge, radio frequency radiation.
This manual belongs to both SensoCard and SensoCard Plus meters. The only difference
between them is the talking ability of SensoCard Plus. So if it is not specially indicated, all
instructions are relevant to both meters.
Note! In this manual if ”SensoCard” is written, it refers to both SensoCard and
SensoCard Plus meters.
To get the best from your SensoCard meter, please take the time to become familiar with.
Read and understand the instructions in this manual before using your meter. Follow the
instructions included in the ”Maintenance” section to prolong life and accuracy of your meter.
This guide should tell you everything you need to know about operating SensoCard meter,
however it is recommended that you visit your medical doctor, specializing in diabetes treatment
if you need further advice.
Keep this manual in a safe place so that you can find and consult it any time. If you have any
technical questions not included in this manual, please contact your local distributor.
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SensoCard
INTRODUCTION
Content of SensoCard kit:
SensoCard blood glucose meter (D45-8001-x)
Instruction For Use (D45-9201-x)
Instruction For Use in pictures (D45-9202-x)
Lancing device (ALT-4451-x)
8 pcs. Disposable, microbiologically sterile lancets (ALT-4414-x)
1 pce. Check-strip (D45-4001-x)
Content of SensoCard Plus kit:
SensoCard Plus blood glucose meter (D46-8001-x)
Instruction For Use (D45-9201-x)
Instruction For Use in pictures (D46-9202-x)
Lancing device (ALT-4451-x)
8 pcs. Disposable, microbiologically sterile lancets (ALT-4414-x)
1 pce. Check-strip (D45-4001-x)
All parts are microbiologically clean.
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SENSOCARD METER EXPLAINED
SensoCard indicates blood glucose concentration by checking the reaction between chemical
reagents and the blood drop on the test strip. The reaction triggers, the generation of a current
in the test strip's reagent zone and this current is conducted to the meter. The current is in
correlation with blood glucose concentration. Therefore the meter can determine blood glucose
concentration by measuring the extent of current flow.
The whole measuring process is controlled by a microprocessor inside the SensoCard meter.
The microprocessor also controls the internal calibration of the device and if any failure is
detected in the operation, a relevant error message is displayed (see section ”Error
messages and Troubleshooting”).
SensoCard automatically stores measured data together with the current date and time. The
memory capacity is large enough to store the data of the last 500 tests. Stored data can also
be uploaded to a host computer via IR interface with the help of an additional device named
LiteLink (shipped separately upon request).
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UNIQUE FEATURE OF SENSOCARD PLUS
This feature is a great help for those people who may have problems with reading displayed
characters from the screen. By using the speaking function of the device, possibility of
misreadings caused by poor sight can be reduced significantly.
All the important instructions and values that are displayed on the screen are also told by
SensoCard Plus. Clear and simple sentences of the device make SensoCard Plus a very
easily usable blood glucose meter. There is no need for further explanation of the sentences
told by the device as they are self explaining sentences. Just follow the instructions as you
hear them and you will use SensoCard Plus without any difficulty.
Data telling is available in two languages by default: English and German.
Note: SensoCard Plus always gives a typical beeping voice when switching off.
FOR USERS HAVING PLASMA EQUIVALENT
CALIBRATED METER
This section refers only to users who have plasma equivalent calibrated
meter. If your meter is plasma equivalent calibrated, than ”Plasma equivalent
calibrated” is written on the label at the back side of your meter.
Laboratory blood glucose measurements can be made either from whole blood samples or
from plasma samples (liquid portion of blood without red blood cells). Both methods are widely
used, neither is more accurate than the other. However, there is a slight difference between the
results obtained from the two samples. Values of plasma measurements are usually 10% to
15% higher than their whole blood equivalents. So if plasma result is 221 mg/dl, you may have
your whole blood reading within the range of 190 mg/dl to 200 mg/dl. Because of the slight
difference, result values obtained from the different methods cannot be simply compared.
Plasma calibrated SensoCard meter displays the result of blood glucose measurement as it
had been obtained from the plasma reading. So the glucose content that is displayed by the
meter is the glucose content that would be in the plasma. Therefore results of the measurements
can be easily compared with the results obtained from a laboratory using plasma for readings.
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SensoCard
Important!
It is important to know, that Plasma calibrated SensoCard uses only whole blood for
reading. To get plasma result, Plasma calibrated SensoCard converts the result of the
whole blood measurement to plasma glucose value.*
* Paul D'Orazio, Robert W. Burnett, Niels Fogh-Andersen: Approved IFCC Recommendation
on Reporting Results for Blood Glucose, IFCC-SD, WG-SEPOCT Document Stage 1, Draft 9,
September 2003
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