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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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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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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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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IMPORTANT PRECAUTIONS
Always operate SensoCard blood glucose meter according to the instructions described
hereafter. If the equipment is used in a manner not recommended by this manual, the warranty
provided by the manufacturer may be lost.
It is essential to read and follow the information below :
SensoCard is designed to be used ONLY with SensoCard Test strip and no
other strips. Always check if the 3-digit code on the vial of strips you are using
matches the 3-digit code appearing on the meter's screen. If it does not, then enter the
code into the meter (see the ”Strip code setting” section).
SensoCard meter is calibrated to be used only with fresh capillary blood.
No venous blood or plasma is suitable for accurate monitoring of glucose level.
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TECHNICAL DATA
SensoCard SensoCard Plus
Batteries: 1 pce. 3V, type: CR2032 2 pcs. 3V, type: CR2032
Battery lifetime: 1 year or 1500 measurements 1 year or 1000 measurements
Calibrated for: SensoCard Test Strip
Average test time: 5 sec
Sample volume needed: min 0.5 μl capillary blood
Measuring range: 1.1 – 33.3 mmol/l (20 - 600 mg/dl)
Display: under 1.1 mmol/l: Lo, above 33.3 mmol/l: Hi
Memory capacity: last 500 results with time and date
Strip-code range: 1-UU6 (alphanumerical)
Coding system: internal with Code-card
Automatic switch on: upon insertion of test strip
Automatic switch off: in 2 minutes after the last button activation
Operating temperature: 10 - 40°C
Relative humidity: < 90% RH
Size: 45 x 90 x 7 mm 55 x 90 x 15 mm
Weight (with batteries): 64 g 96 g
PARTS OF SENSOCARD AND SENSOCARD PLUS METERS
1. OK button 6. Code-card slot
2. Up button 7. Battery holder
3. Down button 8. IR data output interface
4. Display 9. Loud-speaker (only in SensoCard Plus)
5. Strip holder slot 10. Strip ejector button
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1
2
3
4
5
6
7,
8
9,
6
10
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ABOUT TEST STRIP
SensoCard is designed ONLY for in vitro use with SensoCard Test strip.
No other strips will give you an accurate result.
Always check if the 3-digit code on the bottle of strips you are using, matches the 3-digit
code you have entered in your meter. If they are not the same your measuring result will be
incorrect (see section ”Strip-code setting” later).
Each vial of strips is labeled also with a date of expiry. Always use the strips within three
months from the date of opening and never use the strips if they are expired.
Before testing always make sure both meter and strips are at room temperature.
Note: SensoCard Test strip reacts with blood glucose forming a current. The
intensity of the current is proportional to blood glucose concentration. SensoCard
meter detects generated micro-current and calculates glucose concentration.
1. Flat wire conductor
2. Reagent zone
3. Reagent window
SensoCard Test strips are sensitive to heat and mechanical damage – do not use strips if you
suspect such danger may occur. Always keep the strips in their original package, close the
vial each time when you removed a strip.
Do not expose the vial of strips to direct sunlight or store it near any heating device (radiator,
etc). Unused strips which are stored in the original capped vial under the circumstances
described in this chapter, remain stable until the expiration date (indicated on bottle-label).
Test strip must be shipped and stored at 8 - 30°C (46 - 86 F). Avoid both freeze and extreme
heat.
Important!
Read the Instructions for use of SensoCard Test strip before you start to use it!
Always note the date of the first opening of the vial of strips and use the strips within
three months from that date.
Use the removed strip immediately and always close the vial carefully.
If the strips were stored below or above room temperature, wait at least 30 minutes
before opening the vial.
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Strip insertion and use
The strip must be inserted into meter's strip holder with the black side facing upwards and with
the squared end pointing towards the device. The meter will turn on automatically by inserting
the test strip. Always ensure that the strip is fully and securely inserted into the centre of the
strip holder. Make sure that enough blood – 0.5 μl – is applied to reagent area, located at the
tip of the arrowhead end of the strip. The little reagent window at the end of the strip should
fill up completely if sufficient amount of blood is applied.
Note: On insertion of test strip meter will turn on automatically.
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insufficient amount of blood
sufficient amount of blood
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BEFORE STARTING MEASUREMENT
Readings might be effected by:
Skin contaminants: Always wash and dry your hands thoroughly before taking your
blood sample and using SensoCard. Wash your hands with warm water, this also stimulates
blood-stream. If you have difficulties in obtaining your blood sample, try hanging your arm
down before pricking your finger. It helps to increase the blood flow.
Severe dehydration may lead to low measurement results.
Abnormally high concentration of Vitamin C (Ascorbic Acid) may lead to high results.
Hematocrit (red blood cells volume) level in blood also has an influence on measurement
result. If the hematocrit level is over 55% (>55%) the measurement results may be too
low, if however, the hematocrit level is below 30% (<30%) the meter may yield unusually high results.
In case of dialysis the hematocrit level of blood may vary. This may influence the
displayed glucose level.
BLOOD SAMPLING
It is recommended to use the lancing device and disposable lancets packed together with the
meter to prick your finger. If you use them, please read the following instructions too:
Before using them, please make sure to wash your hands thoroughly with warm water and then
dry them before pricking.(Thereby you stimulate the blood stream!)
Use the side of the finger-tip for pricking, however alternatively every other part of your palm
can be pricked also.
Wipe off the blood that disperses first after pricking and then collect one drop without pressing
your finger too hard.
Pressing your finger pad from the lower part up will help you to produce a blood drop.
Warning!
Excessive rubbing may influence measurement results.
Read the lancing device’s instructions for use before you start to use it.
Dirt or contaminants on finger, or insufficient amount of blood may lead to inaccurate
measurement results.
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STRIP-CODE SETTING
Your SensoCard meter and SensoCard Test strip form together an accurate measuring system.
To assure that the meter and the strips work together properly, the SensoCard meter must be
coded to the strips what are used actually. Coding the meter means entering the code value
which is assigned individually to each vial of strips. The code is a three-digit alphanumerical
number affixed to the strips’ vial which influences the accuracy of the meter while it calculates
glucose concentration.
There are two ways how you can enter strip-code
by using Code-card (included for every vial of strips), or
by setting the code value manually - which is printed onto the label of the strips’ vial.
Important!
Verify that the code displayed on LCD matches the code number on the vial of test
strips each time you use your meter. The code needs to be entered only once for each
vial of test strips. The meter will memorise the code until you change it.
If your Code-card is broken or missing, please follow instructions for
”Setting strip-code manually” in this chapter!
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Setting strip-code with Code-card
1. Switch the meter on (with the OK button or by inserting a SensoCard Test strip into the
strip holder). After the initial full screen, the actual code value will appear on the LCD. A large
3-digit alpha-numerical value, ”CODE” caption and a strip icon with a flashing arrow will be
displayed. The code value displayed on the screen must be compared to the code value printed
onto the label of the SensoCard Test strips' vial. If they are not the same, go on with the code
setting process.
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Important to set code!
2. Press the Down button on the right side of meter to enter the
”code setting” function. A simple animation displayed on the
screen will request the Code-card to be inserted into its slot on the
left bottom side of the meter.
3. Insert and remove Code-card in Code-card slot with one expressed move without
interruption.
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4. The meter returns automatically to the test screen where the recently set code value is
displayed, showing that it has been stored in SensoCard. Now the meter is ready to perform
the blood glucose test with the new code value.
Warning!
SensoCard waits for the insertion of the Code-card for 60 seconds. If the Code-card is not
inserted within 60 seconds the meter displays an E-C error message and the actual code value
remains the same as before. In this case please repeat the coding process again.
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Ready for measurement!
Setting strip-code manually
When the Code-card is missing or it is damaged, you may want to set the strip code manually.
The range of the available code values covers 1 – UU6. Digits that can be set vary between
0-U (18 unique values each : 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, A, C, E, F, H, L, P, U). The value of the
third digit can vary between 0-6, only if the first two digits' values are ”U”. In order to set the
code manually follow the instructions below.
Press the Down button on the right side of meter and when
the code requesting animation is displayed press the Down
button again. A large 3-digit alphanumerical code value will
appear on the screen with flashing first digit.
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Code value can be adjusted digit by digit. After entering this menu function modify the value
of the first digit with the Up and Down buttons. By pressing the OK button, the first digit will
be set and the second digit will be flashing, indicating that now its value can be modified. Use
the Up and Down buttons to adjust the value of the second digit similarly to what you did with
the first one and then press OK when you are ready. Now the last digit should be flashing. After
you have set the value of the last digit as well, store the new code by pressing OK. The meter
will return to the test screen where the new code value will be displayed. Compare this code
value with the code value affixed to the strips' vial label. If they are the same you are ready to
perform blood glucose test, if not repeat the code setting procedure again.
Note: If no buttons are pressed for 2 minutes, the meter automatically turns off
and the actual code value remains the same as before.
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MEASURING WITH THE METER
Before you start the test make sure you have everything ready you might need: meter, test strip,
finger pricking device, some tissues. Now, put your meter on a clean flat surface. Wash your
hands thoroughly.
1. Switch SensoCard on either by inserting test strip
into its strip holder or by pressing the OK button. By pressing
the OK button test screen appears on the display. Compare
the displayed code value with the code value indicated on the
strips' vial label. It is recommended to check the strips’ expiration
date as well.
In the lower right side of the screen a strip icon and a flashing arrow will instruct you to insert the test strip. Take a test
strip and holding it by its arrow head shaped end, insert it
firmly into the middle of the strip holder. The black side of
strip must be face up and it must be inserted all the way into
the holder so that the manufacturer's logo will be seen at the
entrance of the strip holder.
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If the strip is in its right place the screen changes: instead of the
flashing arrow a flashing blood drop icon appears on the LCD,
indicating that the meter is waiting for blood dropping.
Note: SensoCard can be switched on by inserting
test strip as well.
2. Prick your finger and gently squeeze out a small droplet of
blood (0.5μl is enough). Apply the blood droplet to the tip of
the arrow head shaped end of test strip laterally. Blood should
fill up the reagent zone completely (see picture in the ”Strip
insertion and use” paragraph of the chapter ”About Test
Strip” ). Insufficient amount of blood might result significant
inaccuracy or the failure of the test.
3. Flashing blood drop icon disappears from the screen after the blood
droplet reaches the strip. Flashing clock icon shows that the meter is
performing the test. Do not move or touch strip during measuring time.
4. On the average measurements take 5 seconds, after the result is
displayed on the screen.
SensoCard Plus not only displays but also tells the result in human
voice. If Up button is pressed the meter tells you the result again.
Meter will display ”Lo” if the measured value is under 1.1 mmol/l
(20 mg/dl ) and ”Hi” if the value is above 33.3 mmol/l (600 mg/dl ).
5. When the result has appeared, it is possible to mark it with the
Down button. If Down button is pressed again, the mark disappears.
Marked results will be neglected in case of average glucose level
calculation of the last 7-14-28 days tests' results. For more information
see chapter Memory/ Storing data.
Note: Marks can only be added or removed right after the measurement.
They cannot be changed when recalling them from memory.
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6. After completing the measurement, test strip can be removed from the meter. Push the
ejector button downwards on the left side of the meter to eject the strip.
Test result can be seen on the screen for 2 minutes or until the strip is removed or the meter
is switched off. Meter will automatically store the result in the memory together with actual
date and time. However, it is recommended always to record the test result in a diabetes diary
before turning meter off.
Used strip and lancet are contaminated with blood.
Be careful, follow the relevant, local instructions when
you throw used strip and lancet away.
In case of any error message refer chapter “Error messages
and Troubleshooting”
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Warning!
High or low results which are incorrect may have serious medical consequences. If
your blood glucose is unusually high (greater than 16 mmol/) or low (lower than
3 mmol/l), or if you question your results, repeat the test more carefully with a new strip.
Consult your healthcare professional before making significant changes to your diabetes
medication program. Do not ignore physical symptoms.
Electromagnetic interference and electrostatic discharge may interfere with meter.
Do not use near highly radiant devices, eg.: mobile phone, microwave oven.
Do not perform test with damaged test strip.
Make sure that the test strip is inserted properly. Improper position of test strip will
cause inaccurate test result.
Do not move or remove test strip during measurements.
Do not perform test at extreme conditions. Different external temperature from the
specified operating temperature range or too high humidity (eg.:humid bathroom)
might effect the accuracy of test result!
When the meter was stored in a too cold or warm place, wait for at least 30 minutes
until meter and strip reach room temperature.
MEMORY
SensoCard is able to store up to 500 measurements with related times and dates.
Storing data
SensoCard meter automatically stores each test result when it switches off. If memory is full,
the oldest result will be lost while the new result will be added.
False or control measurement's result can be marked, thus not to be calculated in the average
glucose level of the last 7-14-28 day long time periods.
Results can be marked after measurements only by pressing the
Down button.
An exclamation mark will also appear on the display's lower left side
when recalling marked results from memory.
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Recalling data from memory
Stored data can be retrieved from memory by selecting MEMORY
mode. Press the Up button on the right side of SensoCard after
switching the meter on to enter MEMORY mode. Result of the last
measurement will appear on the screen. Date and time of the
measurement will be displayed in the upper line of the display.
Scroll among stored memory records with the help of the Up and Down buttons. When you
reach the earliest memory record, meter stops scrolling. Those results that were marked after
measurement will be displayed with exclamation mark (!) when recalled.
By pressing the OK button, meter will enter the “Average calculation” mode. Press the OK
button again to return to test mode.
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Average calculation
SensoCard is able to calculate the average glucose level of the last 7-14-28 days tests'
results. Calculated average contains all test results from the selected 7, 14 or 28 day long time
periods, except the marked ones. However, this function only operates accurately if date and
time are precisely set.
To study the average value of your glucose level enter first the
MEMORY menu by pressing the Up button after switching on the
device. In the MEMORY menu press the OK button to display
the average glucose level of the last 7 day period. Use the Up and
Down buttons to switch between the average of the last 7, 14 and
28 day long time periods. By pressing the OK button you will
return to test screen.
Note: If there is no test result in the memory – after memory deletion or before
the first test of a new device –, no average value will be displayed.
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OVERVIEW OF FUNCTION MENUS
By keeping the OK button pressed after switching on, meter will offer alternatively six functional
modes: calibration screen “CAL”, data download screen “PC”, time set screen “SEt”, memory data delete screen ”dEL”, measurement unit selection screen ”SEt” and switching to
speaking function screen ”SEt” in case of SensoCard Plus meter. These function modes will
follow each other as you keep pressed the OK button in the same order as they were mentioned
above. To enter one of the function modes, release the OK button when the desired function's
tag is displayed.
SETTING DA TE AND TIME
SensoCard meter is used world-wide, therefore it works both with a 12 and a 24 hour system.
It is not able to recognise “leap” years.
Time is displayed in the upper left corner, while date appears in the upper right corner of
screen.
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Switch meter on with the OK button and keep it pressed.
Select the time setting menu by releasing the OK button when
“SEt” time appears on the screen.
After entering the time setting menu, only hours will be displayed in the upper left corner of the screen. Hours can be
modified with the help of the Up and Down buttons. By pressing and holding down the buttons, hours can be set in fast
mode. As you scroll hours, clock mode changes at each
rolling over between 12 hour clock mode and 24 hour clock
mode. After setting the hours press the OK button to switch to
minutes setting function and use the Up and Down buttons
for adjusting here as well.
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When time is set press the OK button again to go on to date setting. In the upper right corner
first month then day will be displayed. They can be adjusted with the Up and Down buttons
and set with the OK button similarly to time setting.
After time and date are set, the meter can be switched off by pressing the OK button. Changes
will be stored automatically.
Note: meter switches off automatically in 2 minutes if you do not press any key.
PC MODE
In ”PC” mode data stored in meter’s memory can be downloaded to PC based computer. To
download data, an additional adapter – called LiteLink IR adapter – is needed to establish
data communication connection between PC and SensoCard meter. LiteLink adapter
together with data communication control program is shipped separately upon buyer’s
request. Data management program on PC side and manuals containing all information on
data downloading, installation, operational settings are attached on CD.
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Switch the meter on with the OK button and keep it pressed until
“PC” mode appears. Release the button.
Target LiteLink adapter's IR interface with SensoCard meter's IR
output. To start data transfer press the Up or Down button on
SensoCard.
When data transfer is finished, meter will switch off
automatically.
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SELECTING MEASUREMENT UNIT
(mmol/l – mg/dl)
SensoCard meter is able to display measured results in two measurement system units:
mmol/l or mg/dl. Contact your healthcare professional to check which unit is preferred in your
country.
Note: Changing of measurement unit doesn't effect test results, only the way it is
displayed. 1 mmol/l equals to about 18 mg/dl. So for the same blood glucose level 5.4 mmol/l
or 97 mg/dl will be displayed depending on which measurement unit is selected.
To choose between the two measurement units, after switching
on the meter keep pressed the OK button until ”SEt” and
mmol/l with mg/dl is displayed on the screen.
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After entering this menu only the recently active unit will appear
on the screen. Switch between the two possible units (mmol/l and
mg/dl) with the help of the Up and Down buttons. When the
desired unit is selected, store your setting by pressing the OK
button. Meter will switch off automatically.
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DELETING DATA STORED IN MEMORY
All data in memory can be deleted in ”dEL” mode. After deletion
default data setting will be restored (set by Manufacturer:
! 5.4 mmol/l).
Switch meter on with the OK button and keep it pressed until
“dEL” appears on the screen, then release the button.
To avoid data loss by mistake, memory
deletion will only be executed if after entering this menu first
Down button and right after Up button is pressed. After deletion
meter switches off automatically.
Important!
It is possible to exit from the memory delete mode without loosing
data by pressing the OK button or by pressing the buttons in any
order other than first Down button then Up button. Data will not be lost either if meter switches
off automatically after 2 minutes.
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SWITCHING TO SPEAKING FUNCTION
SensoCard Plus meter can speak in two different languages by
default: English and German. To switch between these two
languages or to switch loud-speaker off enter loud-speaker
switching menu. To enter this menu, after turning on the device
keep pressed the OK button until ”SEt” and the sign of a
loud-speaker is displayed on screen. Then release OK button.
Select ”GEr” to set German language or select ”EnG” to set
English with the help of the Up and Down buttons. Choose
”OFF” to switch off loud-speaker. Always the actual setting is
displayed on the screen. Store your setting by pressing OK button.
Meter will switch off.
Note: If speaking function is switched on, the sign
of loud-speaker will be displayed on the screen all the time.
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BATTERY REPLACEMENT
SensoCard meter is powered by 1 pce, while SensoCard Plus 2 pcs of round
cell batteries, type CR2032. Other types of batteries are not allowed to be used
under the guarantee terms and conditions!
When the batteries are getting low, a battery icon is displayed on the
screen. It indicates that batteries are needed to be replaced soon.
When battery icon is displayed the meter is still operating accurately,
but replacement of batteries should be done not later than finishing the
next 10 test measurements. Find inside two batteries in SensoCard
Plus, but only one battery in SensoCard.
After battery icon is displayed, SensoCard
Plus tells you every time you witch off the
meter to replace batteries.
If 10 test measurements are done after the first appearance of the battery
icon, the error message “E-6” will be displayed on the screen when
the meter is switched on. It means that it is not allowed to perform
any more tests until the batteries are changed.
Important! Keep meter switched off while replacing batteries.
The battery holder is located on the back side of the meter. The battery cover can be opened
by pushing the narrow isolated part of the cover upwards. Replace the old, discharged batteries
with new ones. Make sure the ”+” and ”–” poles are properly positioned. Click the battery
cover back into its place, then check the equipment’s ability to operate by switching the
meter on.
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SensoCard
SensoCard Plus
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Important!
If the instrument does not work after battery replacement: replace the batteries again,
press and hold the OK button down for about 15-20 seconds, then replace batteries.
If batteries are replaced in 60 seconds, date and time are not needed to be reset.
After 60 seconds, date and time should be reset.
Code number and test data are stored and they will not be lost due to battery replacement.
They will be available after battery replacement as well.
Electrostatic discharge may interfere with the meter. In the case of unusual effects (turn
off, reset, errors) follow the instructions in the “Error messages and Troubleshooting”
chapter.
MAINTENANCE
If SensoCard is used according to this Instructions For Use, only minimal maintenance is
necessary. However, to always have accurate test results, we recommend you to perform the
following operations:
If necessary, use a wet cloth for cleaning the whole surface of instrument.
After maintenance check functionality. For more details see chapter
“SensoCard system checking”.
Warning!
Protect the inside of the meter from water!
Never immerse the meter or hold it under running water!
Avoid disassembling the meter, repairs should be done exclusively by authorised
service.
Keep in touch with your local distributor’s technical service, if you need assistance
contact them.
SENSOCARD SYSTEM CHECKING
Checking the measuring accuracy of the meter is recommended after every maintenance.
Check test of SensoCard can be carried out by supplied Check-strip or with CareSens control
solution. CareSens control solution can be obtained from Manufacturer upon user's request
for additional charge (see exact address and phone number of manufacturer at the end of this
manual).
To perform system checking, please follow the steps of one of the checking possibilities
below.
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SensoCard
Checking with Check-strip
Press OK button and keep it pressed until “CAL” appears on the
screen, then release it.
Strip icon will be displayed together with flashing arrow icon,
indicating that the meter is waiting for strip insertion.
Insert Check-strip – which is included in SensoCard
package – into strip holder with the “Check” label facing
upwards. Meter will perform the measurement and display
the result of the check.
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SensoCard
If the displayed value is within the given range – that is indicated on
the label affixed to the Check-strip holding pocket –, the meter is
operating perfectly. Remove Check-strip, and switch the meter off.
If the result of the self test is not in the given value range, perform
the self test again. If test result's value is still out of given range,
contact your local distributor and ask for help.
Important!
Do not apply blood on the Check-strip!
Protect Check-strips against physical damage and keep them in a safe place.
If Check-strip is damaged or lost, contact your local distributor for advice.
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SensoCard
Checking with CareSens control solution
Press OK button and keep it pressed until “CAL” appears on the
screen, then release it.
Strip icon will be displayed together with flashing arrow icon,
indicating that the meter is waiting for strip insertion. Compare
displayed code value with code value written on the vial of
SensoCard Test strips. If code values are not the same please
set the correct code value before continuing see “Strip code
setting” chapter for details.
Insert the SensoCard Test strip and push it gently until the end
position. The black side with the manufacturer's logo should be
facing upwards.
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SensoCard
Shake control solution bottle well before use. Drop CareSens
control solution to the reagent area of test strip, which is at the
tip of the arrowhead-shaped end of the test strip. Meter will
perform measurement and display the result in the active unit
(mmol/l or mg/dl).
Check if displayed result is within the range of L1 or L2 value
indicated on the label of SensoCard Test strip's vial. If the
result is within the range, your meter works perfectly.
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SensoCard
If the result of self test is not in the given value range:
perform self test again.
check if the code value displayed on LCD is the same as the code value written on
SensoCard Test strip's vial.
check meter with Check-strip as well.
see chapter ”Maintenance” and/or “Error messages and troubleshooting“ for
further advice.
If test result value is still out of the given range, contact your local distributor and ask for help.
ERROR MESSAGES AND TROUBLESHOOTING
When using SensoCard meter, some error messages consisting of a letter ”E” followed by a
number or letter might appear on the display. The cause of these errors may be that you are
not doing something correctly or that there is a problem with the meter. In case of an error
message pressing any button, the meter will switch off automatically.
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SensoCard
Important! Do not continue test if an error message is displayed!
This chapter lists error messages, explains their means and possible reasons causing malfunctioning.
1. Instrument is not working
Batteries are discharged and need to be replaced.
If the batteries are not low, remove them and keep the OK button pressed for about
15-20 seconds then place the batteries back.
Check that the battery poles are correctly positioned and that the battery cover is closed
properly.
2. Meter is very cold or too warm.
Allow meter to gradually reach room temperature.
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3. E-O error message
If this error message remains on screen after turning meter on, the meter has got
damaged. Please remove the batteries and keep the OK button pressed about 15-20
seconds the batteries and turn on the meter. If E-0 appears again, please contact your
local distributor.
4. E-2 error message
Strip has been removed from the instrument during measurement.
5. E-3 error message
Used strip is inserted. Repeat measurement with new test strip!
Check-strip is inserted instead of test strip. Replace it with a test strip.
Strip is not correctly inserted.
Blood was applied before strip insertion. Repeat measurement with new test strip!
6. E-5 error message
Strong electromagnetic field (e.g.: mobile phone) or high intensity electrostatic discharge
interfere with the meter. Repeat the measurement.
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SensoCard
Meter is damaged. Check the meter with Check-strip, see “SensoCard system
checking” chapter.
7. E-6 error message
Batteries are low. Replace the batteries.
High intensity electrostatic discharge may influence the meter. Please remove the
batteries and keep the OK button pressed about 15-20 seconds. Replace the batteries
and turn on the meter. If E-6 appears again, please change the batteries.
8. E-7 error message
Insufficient amount of blood was applied on strip. Repeat test with bigger drop of
blood.
High intensity electrostatic discharge may influence the meter. Please repeat the
measurement.
9. E-8 error message
Test wasn't performed properly. Repeat test with new test strip and be more careful
when performing each step.
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SensoCard
10. E-9 error message
External temperature is too high or low (out of the range 10-40 °C). Wait at least 30
minutes before using the device, until it completely reaches room temperature.
SensoCard is able to check external temperature. If it detects values not conforming to
its operational requirements, the following error messages will be displayed:
An arrow icon directed downward and the E-9 error message together indicate low
temperature (below 10 °C).
An arrow icon directed upward and the E-9 error message together indicate high
temperature (above 40 °C).
11. E - C error message
This error message may appear during using Code-card. There might be one of the following
problems:
Code-card is damaged. Please check the integrity of Code-card. If you can find any
mechanical damage on Code-card, contact your local distributor.
Code-card insertion or removal was not continuous. Insert and remove Code-card
with a bit quicker expressed move.
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SensoCard
Code-card insertion or removal was too slow. Repeat Code-card insertion without
interruption.
12. Flashing result
If temperature gradient is too high, SensoCard still keeps on operating, but the
displayed result will be flashing, indicating the abnormal operational circumstances.
Be cautious with these test results, they might be inaccurate.
13. Instrument shows Lo constantly
Code setting is not correct. Check and set the proper code value.
Insufficient amount of blood was applied on the strip. Repeat test with a bigger drop of blood.
14. Instrument shows Hi constantly
Code setting is not correct. Check and set the proper code value.
15. Battery symbol appears on display
Batteries are low. Replace batteries.
If error messages cannot be eliminated by applying the recommendations above, please contact
your local distributor for advice.Thank you for your confidence in purchasing our product.
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SensoCard
MANUFACTURER'S WARRANTY
77 Elektronika Kft. warrants SensoCard blood glucose meter against defects in materials
and workmanship for a period of three years from the date of purchase. The warranty is lost if
the instrument is misused, poorly maintained or is tampered with. Liability under this warranty is limited to the repair of defective parts or – at the discretion of 77 Elektronika Kft. –
to the replacement of the instrument. The right to rescind the purchase agreement exists only
if the replacement is also found to be defective. Claims other than these will not be dealt
with.
The warranty is not valid if the damage results from misuse, maltreatment, tampering, human
error and the use of extreme.
This warranty is valid only if the date, the stamp and the signature of the dealer are recorded
on the warranty card on the date of purchase.
The warranty period is not to be extended by any claim made under this warranty.
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SYMBOLS
0197 98/79/EEC IVD directive, SensoCard meter
0120 93/42/EEC MDD directive, lancet
In vitro diagnosticum
Information inside
Warning !
Manufacturer
Temperature range
Biological risk
Expiry date
Manufacturer:
77 ELEKTRONIKA Kft.
1116 Budapest, Fehérvári út 98.
HUNGARY
Tel: + 36 1 206 - 1480
Fax: + 36 1 206 - 1481
E-mail: sales@e77.hu
www.e77.hu
Your local distributor:
Meter serial number:
Service records: VERSION: 2.1 2006.05.
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SensoCard
77 Elektronika Kft. HUNGARY
www. e77.hu
Fehérvári út 98. H-1116 Budapest
Tel.: +36 1 206-1480
Fax: +36 1 206-1481
E-mail: sales@e77.hu
D45-9201-3
2.1 2006. 05.v.
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