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Ed. 2012/02
www.vedalab.com
[email protected]
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The VEDALAB EASY READER is an innovative meter for
reading immunochromatographic rapid test cards using a
high-resolution CCD-camera and integrated software
created for analysing pictures.
The EASY READER has a removable chip containing all
the necessary software for rendering quantitative or semiquantitative results from the test lines absorbance values.
Depending on the tested parameter, results can be obtained
from whole blood, plasma, serum or urine samples.
The meter also has an built-in printer for keeping archives of
all the information related to each patient (name, date of
birth and results) and to the user having performed the
analysis.
Key Features of the VEDALAB EASY READER
Key Features of the tests
End
Principle of the reaction
Principle of the reader
Key Features
of the VEDALAB EASY READER
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- Compact, light (1Kg) and convenient
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- Fast, simple, easy and cost effective assays
- No need of a batch or product specific code chip (common blank and
calibration cards)
- Built-in printer
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- Possibility to perform assays on the reader without any computer
connection
- Possibility to connect the reader to computer for increased memory
storage capacity.
- Possibility to connect the reader a barcode reader
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- No need additionnal controls
- No service contract required
- Wide range of available parameters
- High output: 60 samples per hour ( up to 120 without printing mode)
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Key Features
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of the tests
- Reagents stable at room temperature
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- No need of a batch specific code chips
- No dilution of samples needed in most of the cases
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- High self life (18 months at least)
- Quantitative positive control available on request
Parameters
- Wide range of parameters of curently 22 items (continously
increasing)
- Tests supplied with all components needed to perform assays
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- Fast results (5 – 20 minutes)
- Most of the tests could be run with very reduced amount of
sample ( 50µL of whole blood or 25µL of serum/plasma)
End
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Principle of the reaction
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If present in the sample, the analyte reacts with the colored conjugate
and flows to be caught by the reagents coated on the membrane. The
intensity of the colored band appearing in the test zone on the stick is
directly proportionnal to the concentration of the analyte.
Positive result
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Parameters
2 line parameter
sample
conjugate
Nitrocellulose
membrane
3 line parameter
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1st test
line
2nd test
line
Control
line
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Negative result
End
sample
conjugate
Nitrocellulose
membrane
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Principle of the reader
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The VEDALAB EASY READER is based on quantitative
immunochromatographic technology by measuring the intensity of the
reaction on a test cassette.
The CCD camera of Easy reader can measure the colour intensity and
determine the concentration of analytes in a sample.
CCD
camera
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Quantitative
or
qualitative result
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Simplified
procedure
Detailed presentation
Kit composition
Connection
Parameters
Changing E-prom
Changing paper
Questions
Check
Assay procedure
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Immediate or countdown mode
Inserting the test card
End
Results and printing
Simplified
procedure
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Start
1) Place the instrument under non-corrosive environmental conditions,
on a flat, even surface that is free of dust, water (or any liquid) and
strong vibrations.
2) Install the required E-prom
3) First connect the keyboard to the reader
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4) Connect the reader to a power source
5) Press the switch on the back of the reader to start using it.
Parameters
6) Press the "Start" button
7) Select the parameter (only for multi-parameter E-prom)
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8) Input the patient’s data needed to identify the sample via the keyboard
9) Perform the assay procedure as indicated in the leaflet of the
measured parameter.
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10) Select “immediate” or “countdown” mode
11) Insert the test card into the meter
End
12) Read the result
Detailed presentation
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Parameters
Kit composition
- Easy reader
- Electrical cords
(adapter and adapter cord)
- Keyboard
- E-prom
- Thermal paper roll
- Calibration device
- Blank device
- Instructions for use
Questions
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Not in box but required to perform a test:
- Timer
- Gloves, alcohol wipes and bandages
- Lab pipettes and tips
Connection
Connection
Detailed presentation
Before connecting the reader to a power source, check that the local power source
is compatible with the supplied adapter (input: 100 to 240 volts AC, 50 to 60 Hz).
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IF NOT, DO NOT CONNECT THE INSTRUMENT!
1
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Parameters
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First connect the keyboard to
the reader by inserting the
keyboard cord into the connector
labelled “KEYBOARD” at the back
of the reader.
4
2
Connect the supplied adapter cord to the
connector labelled “7.5 V . 3A” at the back
of the reader.
3
Connect the other end of the adapter
cord into the output connector of the
adapter.
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4
Plug the male end of the adapter
cord into a grounded outlet with the
appropriate voltage.
End
5
Press the switch on the back of the
reader to start using it.
5
2
3
1
Keyboard
Changing the E-prom
Detailed presentation
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Changing the E-prom
For the proper functioning of the EASY READER®, an E-prom (chip)
must be installed in the meter.
Each E-prom (chip) contains the calibration data specific to each
parameter or a range of several parameters.
The following instructions describe how to replace a chip.
Before changing the E-prom, switch the reader off
Parameters
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1. Open the
protective cover.
3. Remove the
E-prom.
4. Replace with the
required E-prom.
2. Lift up the
paper roll
Changing paper
Detailed presentation
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Changing paper
Please open the blue lid of the printer. A little section on the right hand side
makes it easier to grip the lid.
Cut the beginning of the roll of thermo printer paper in such a way as to
create a triangular point on the right hand side. Insert the triangular point
underneath the paper feed until the paper appears and you can pull it out by
hand. If you can not manage this properly, it is possible to activate the
linefeed using display menu.
Paper input
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Paper output
Parameters
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
Please take care that the paper is never pulled out
backwards against the mechanical linefeed. If a paper
jam or a similar printer problem happens, please
always cut the paper before printer paper input and
then always cut the paper first and then pull it out by
hand. Never turn the paper roll backwards.
Check
Check
Detailed presentation
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Parameters
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This step allows the control of the meter with a
calibration device (check-card). Please read
carefully the insert sheet for the calibration step,
to be properly informed. On the check-card
package are indicated the appropriate limits of
tolerance for meter results.
After selecting Check on the main menu, you will
be asked to insert the blank device to set the
baseline. Please follow the instructions.
It is recommended to check the meter before
starting the measurements. This process should
be performed once a week to verify that the
optical system of the reader is well calibrated.
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This step is necessary to allow exact measurements.
End
Assay procedure
Detailed presentation
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Assay procedure
CAUTION!
Please perform the assay procedure as indicated in
the leaflet of the measured parameter.
Useful recommendations
Selecting Start means activating the real measuring menu.
By pressing the button below Start, a control is automatically
made in order to check whether there is a current zero line
setting or if such a setting should be done. In the case that a
new zero line setting is necessary, please follow the reader
instructions.
After successful zero line setting (or if such a process was
done on the last 24 hours and the meter was not switched off),
you will be asked to input the patient’s data needed to identify
the sample via the keyboard .
End
Assay procedure p.2
Detailed presentation
Assay procedure
Useful recommendations
Page 1 P.2 P.3 P.4
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Start
Useful recommendations for more accurate
results during test processing
1) Switch on the reader and wait for 5 minutes to let it warm up.
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Parameters
Questions
2) Place the cassette horizontally (sample well on the left-hand side)
and add the sample (whole blood, plasma or serum) in the exact
position as indicated in the picture by the arrow.
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Assay procedure p.2
Detailed presentation
Assay procedure
Useful recommendations
P.1 Page 2 P.3 P.4
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Useful recommendations for more accurate
results during test processing
3) When using whole blood sample,
wait for the complete absorption of
the sample (less than a minute). This
is very important to get a clear
background.
Parameters
Questions
4) Add four (4) drops of diluent
without the bottle tip touching the
cassette.
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Assay procedure p.2
Detailed presentation
Assay procedure
Useful recommendations
P.1 P.2 Page 3 P.4
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Useful recommendations for more accurate
results during test processing
5) Keep the bottle vertical in order to
always obtain the right volume of
drops while adding the diluent into the
sample well.
Parameters
Questions
6) Push the cassette firmly into the
reader.
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7) Read exactly the result at the appropriate time indicated in the
instruction leaflet corresponding to the tested parameter.
Assay procedure p.2
Detailed presentation
Assay procedure
Useful recommendations
P.1 P.2 P.3 Page 4
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Useful recommendations for more accurate
results during test processing
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8) Please make sure that test cards will always be well
placed in the correct position into the card holder.
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Parameters
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Assay procedure p.2
Detailed presentation
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Assay procedure p.2
Please input the family name and first name of the patient via
the keyboard. End the input by pressing the ENTER-button.
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Parameters
Questions
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Assay procedure p.3
Detailed presentation
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Start
Assay procedure p.3
Please input the date of birth in the requested format. End the
input by pressing the ENTER-button. Slashes will be generated
automatically .
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Parameters
Questions
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Immediate or countdown
Detailed presentation
Immediate or countdown mode
Immediate
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Start
The immediate reading mode can be used only if the test has already
been performed by the end-user and after waiting for the required
migration time indicated in the specific test leaflet.
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Parameters
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Countdown
The Countdown mode can be used in case the test has not been
already performed by the end-user. The test card is put directly into
the meter after adding the sample and other reagents, if required, as
indicated in the specific test leaflet. The reader will automatically
calculate the reaction time before the result measurement. After
pressing the countdown button, the sample selection screen will
appear. Depending on the parameter, select the corresponding matrix
sample (whole blood, serum, plasma, urine).
Inserting the test card
Detailed presentation
Inserting the test card
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Start
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Parameters
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Insert the test card into the card
holder with the sample well ()
in the opposite direction of the
meter. Checking of chemical
reaction time and result
measurement will be performed
automatically. Information will
appear on the display.
Please make sure that the test cards are always well placed and pushed
into the card holder until they are locked. The correct positioning of the
card will avoid wrong measurements and error messages. When
inserting the test card, you will feel a slight resistance before the exact
final position is reached.Continue to gently push the test card into the
slot until it becomes locked in the correct position.
End
Results and printing
Detailed presentation
Results and printing
The test result will be shown automatically and will be printed
simultaneously, if the printer is “ON”.
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Result is
expressed in the
unit system
compatible with
the measured
parameter.
Parameters
Questions
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By selecting “Measure”, the next test starts. By selecting Readout, the
result can be shown line by line on the display, if the printer is “OFF”.
After having processed the test, the cassette should be considered
potentially infectious and should be discarded accordingly.
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Parameters
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After switching on, this screen appears a few seconds. Then the main menu appears
automatically on the display (click on the slide to see the next one).
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Start
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Parameters
Questions
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End
Click on the black buttons on the front of the reader to see information for « Start »
« Check » or « Settings ».
Start
parameter
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Start
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Parameters
Questions
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Available only with the multi parameter E-prom
Start
parameter
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Start
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Parameters
Questions
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End
Available only with the multi parameter E-prom
Start
parameter
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Start
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Parameters
Questions
Back
End
Available only with the multi parameter E-prom
Start
parameter
Blankcard
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Start
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Parameters
Questions
Back
End
A control is automatically done in order to check whether there is a current zero line
setting or if such a setting should be done.
(Click on the slide to see the next one)
Start
parameter
Blankcard
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Start
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Parameters
Questions
Back
End
A control is automatically done in order to check whether there is a current zero line
setting or if such a setting should be done.
(Click on the slide to see the next one)
Start
parameter
Blankcard
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Start
parameter
Blankcard
Home
Start
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Parameters
Questions
Back
End
(click on the slide to see the next one)
Start
parameter
Blankcard
Patient
Name
Home
Start
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Parameters
Questions
Back
End
Input the patient’s data (family name and first name ) needed to identify the sample via
the keyboard. End the input by pressing the ENTER-button.
Start
parameter
Blankcard
Patient
Name
Birthday
Home
Start
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Parameters
Questions
Back
End
Input the day of birth in the requested format. End the input by pressing the ENTERbutton. Slashes will be generated automatically.
Start
parameter
Blankcard
Patient
Home
Name
Birthday
Reading selection
Start
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Parameters
Questions
Back
End
-By pressing Immediate, the test result will be read immediately without any countdown.
-By pressing Countdown (the test has not been already performed by the end-user),
the reader will automatically calculate the reaction time before the result measurement.
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Countdown
Birthday
Start
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Parameters
Questions
Back
End
Select the sample type either serum/plasma/urine or whole blood by pressing the
corresponding button.
Start
parameter
Blankcard
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Patient
Name
Reading selection
Countdown
New test
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Birthday
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Countdown
New test
Start
Menus
Parameters
Questions
Back
End
Remove the blank card before inserting a new test in the slot.
(click on the slide to see the next one)
Birthday
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Countdown
Birthday
New test
Start
Menus
Parameters
Questions
Back
End
The test card is inserted directly into the meter after adding the
sample and other reagents, if required, as indicated in the specific
test leaflet. (click on the slide to see the next one)
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Countdown
Birthday
New test
Start
Menus
Parameters
Questions
Back
End
The reader will automatically calculate the reaction time before the result measurement.
(click on the slide to see the next one)
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Countdown
Birthday
New test
Result
Start
Menus
Parameters
Questions
Back
End
The test result will be shown automatically and will be printed silmutaneously, if the
printer is “ON”.
Result is expressed in the unit system compatible with the measured parameter.
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Countdown
Birthday
New test
Result
Start
Readout
Menus
Parameters
Questions
Back
End
By selecting Readout, the result can be shown line by line at display, if the printer is
“OFF”.
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Immediate
New test
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Birthday
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Immediate
New test
Start
Menus
Parameters
Questions
Back
End
Remove the blank card before inserting a new test.
(click on the slide to see the next one)
Birthday
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Immediate
Birthday
New test
Start
Menus
Parameters
Questions
Back
End
The immediate reading mode can be used only if the test has
already been performed by the end-user and after waiting for the
required migration time indicated in the specific test leaflet. Reaction
time is measured by the end-user with an external timer. (click on the slide to see the next one)
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Immediate
New test
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Birthday
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Immediate
Birthday
New test
Result
Start
Menus
Parameters
Questions
Back
End
The test result will be shown automatically and will be printed silmutaneously, if the
printer is “ON”.
Result is expressed in the unit system compatible with the measured parameter.
Start
parameter
Blankcard
Home
Patient
Name
Reading selection
Immediate
Birthday
New test
Result
Start
Readout
Menus
Parameters
Questions
Back
End
By selecting Readout, the result can be shown line by line in the display, if the printer is
“OFF”.
Check
Blankcard
Home
Start
Menus
Parameters
Questions
Back
End
Insert the blank device to set the baseline. Please follow the
reader instructions. It is recommended to check the meter
before starting the measurements.
(click on the slide to see the next one)
Check
Blankcard
Home
Start
Menus
Parameters
Questions
Back
End
Insert the blank device to set the baseline. Please follow the
reader instructions. It is recommended to check the meter
before starting the measurements.
(click on the slide to see the next one)
Check
Blankcard
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Check
Blankcard
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Check
Blankcard
Checkcard
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Check
Blankcard
Checkcard
Home
Start
Menus
Parameters
Questions
Back
End
Remove the blank card before inserting the check card in the slot.
(click on the slide to see the next one)
Check
Blankcard
Checkcard
Home
Start
Menus
Parameters
Questions
Back
End
This process should be performed once a week to verify that the
optical system of the reader is well calibrated.
This step is necessary to allow exact measurements.
(click on the slide to see the next one)
Check
Blankcard
Checkcard
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Check
Blankcard
Checkcard
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Check
Blankcard
Checkcard
Home
Start
Menus
Parameters
Questions
Back
End
Compare the obtained results with the expected values (limits of tolerance) of the
calibration device.
These values are printed on the calibration device pouch label.
Settings
Home
Start
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Parameters
Questions
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End
Settings
User address
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Parameters
Questions
Back
End
5 lines of information concerning the user (name, adress, tel,…) can be saved in the
reader using the keyboard. (click on the slide to see the next one)
Settings
User address
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Start
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Parameters
Questions
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End
(click on the slide to see the next one)
Settings
User address
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Settings
User address
Home
Start
Menus
Parameters
Questions
Back
End
(click on the slide to see the next one)
Settings
User address
Home
Start
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Parameters
Questions
Back
End
(click on the slide to see the next one)
Settings
Output
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Start
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Parameters
Questions
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Settings
Output
Display
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Start
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Parameters
Questions
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Settings
Output
Display
Date/Time
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Start
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Parameters
Questions
Back
End
Adjust the date and the time using the three buttons on the front of the reader.
Click “next” to go back to the main menu.
Settings
Output
Display
Language
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Start
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Parameters
Questions
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End
Selecte the appropriate language. Click “next” to go back to the main menu.
Settings
Output
Display
Language
Home
Start
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Parameters
Questions
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End
Settings
Output
Print/Send
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Start
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Parameters
Questions
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End
Settings
Output
Print/Send
Printer
Home
Start
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Parameters
Questions
Back
End
There is a possibility of switching the printer reader ON or OFF.
Home
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Parameters
Questions
Back
End
Using the button below OFF or ON will bring the printer into the requested mode and
then will lead to the appearance of the main menu.
Settings
Output
Print/Send
Printer
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Linefeed
Start
Menus
Parameters
Questions
Back
End
Here you can start the linefeed (Start) and stop it (Stop).
Please use this position, to switch on or switch off the linefeed while putting paper into
the printer.
Settings
Output
Print/Send
Memory
Home
Start
Menus
Parameters
Questions
Back
End
The memory contains a maximum of 28 results. Entering more than 28 results (new
measurements) will always lead to the deletion of the other results.
The results of check card measurements will not be stored.
Settings
Output
Print/Send
Memory
Home
Start
Menus
Parameters
Questions
Back
End
Please give a two-digit input of a number between 01 and 28 on the display using the
keyboard.
When entering 01 the last result will be shown.
Settings
Output
Print/Send
Memory
Home
OK
Start
Menus
Parameters
Questions
Back
End
By choosing No or Quit, you will return to the main menu.
By choosing Yes, the printing process will start.
Settings
Output
Print/Send
Memory
Home
OK
Yes
Start
Menus
Parameters
Questions
Back
End
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Menus
Parameters
Questions
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End
Simplified list
Detailed list
AFP
FOB
LH
CA125
FRT
M-ALB
CEA
FSH
MGL
CK-MB
HCG
PRL
CRP
IgE
PSA
D-Dimers
Insulin
TRP-I
TSH
Simplified list
Parameters
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Parameters
Questions
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Quantitative determination
Reading
time (min)
EASY READER
measuring range
AFP
Alpha feto protein (tumor marker)
10
10 - 300 ng/mL
CA -125
Antigen 125 (Ovarian cancer)
15
15 - 750 IU/mL
CEA
CarcinoEmbryonic Antigen (tumor marker)
15
5 - 250 ng/mL
CKMB
Creatine Kinase MB (Acute myocardial infarction)
15
5 - 200 ng/mL
CRP
C-Reactive Protein (inflammatory process)
D-DIMERS
D-Dimers (deep vein thrombosis)
15
250 - 5000 ng/mL FEU
FOB
Blood in feces (colorectal cancer)
10
10 - 499 ng/mL
FRT
Iron deficiency (anemia)
15
10 - 630 ng/mL
FSH
Follicle stimulating hormone (menopause)
10
5 - 400 IU/L
h-CG
Human chorionic gonadotropin (pregnancy)
15
5 - 1000 IU/L
IgE
Immunoglobulines E (allergy)
10
10 - 800 IU/mL
INSULIN
Insulin hormone (diabetes, insulinoma)
15
5 - 200 μU/mL
LH
Luteinizing hormone
10
5 - 200 IUL
M-ALB
Albumin in urine (diabetes)
10
2.5 - 5000 μg/mL
MGL
Myoglobin (acute myocardial infarction)
15
50 - 500 ng/mL
PRL
Prolactin hormone (lactation)
10
20 - 350 ng/mL
PSA
Prostate Specific Antigen (prostate cancer)
10
1 - 100 ng/mL
TRP I
Troponin I (Acute myocardial infarction)
20
0 - 50 ng/mL
TSH
Thyro Stimulating Hormone (Hypothyroidism)
15
2 - 80 mIU/L
5 or 10
2.5 - 400 μg/mL
(Faecal Occult
Blood)
Detailed list
AFP CA-125 CEA CKMB CRP D-DIMERS
INSULIN
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Start
Parameters
AFP
LH M-ALB MGL PRL
Normal
values
Abnormal
values
Alpha feto protein (tumor marker)
Adult
< 40 ng/mL
> 40 ng/mL
Child
(<1 year)
< 30 ng/mL
> 30 ng/mL
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Parameters
Questions
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FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Reading time
And
Interpretation
Reading time: 10 min
10 - 300 ng/mL - Testicular teratocarcinomas (75%)
- Pancreatic cancers (23%)
- Gastric cancers (18%)
- Cronchogenic cancers (7%)
- Colon cancers (5%)
Other diseases as:
- Viral hepatitis (24%)
- Postnecrotic cirrhosis (24%)
- Laennec's cirrhosis (15%)
- Primary biliary cirrhosis (5%).
Detailed list
AFP CA-125 CEA CKMB CRP D-DIMERS
INSULIN
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Start
Parameters
CA -125
Adult
Menus
Parameters
Questions
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End
LH M-ALB MGL PRL
Normal
values
Abnormal
values
Antigen 125 (Ovarian cancer)
< 35 IU/mL
> 35 IU/mL
FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Reading time
And
Interpretation
Reading time: 15 min
15 – 750 IU/mL - Use in monitoring of epithelial ovarian cancer
treatment.
- May be also elevated in patients with cervical,
fallopian tubes and uterine cancer and
endometriosis.
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CEA
LH M-ALB MGL PRL
Normal
values
Parameters
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> 5 ng/mL
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
CarcinoEmbryonic Antigen (tumor marker)
< 5 ng/mL
Menus
Abnormal
values
FOB
5 - 250 ng/mL
Reading time
And
Interpretation
Reading time: 15 min
Increase in :
- Colon, stomach, pancreas, lung cancers (75 %)
- Breast, head and neck, ovary cancers (50%)
-in 90 % of all with solid-tissue tumors especially
with metastases to liver or lung.
Other diseases as:
- Alcoholic cirrhosis, chronic active hepatitis,
obstructive jaundice.
- Renal failure
-Fibrocystic disease of breast.
Other factor of CEA increased levels:
- 19 % of heavy smokers and 7 % of former
smokers have CEA > 5 ng/mL.
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CKMB
LH M-ALB MGL PRL
Normal
values
Parameters
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> 10 ng/mL
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Creatine Kinase MB (Acute myocardial infarction)
< 10 ng/mL
Menus
Abnormal
values
FOB
5 - 200 ng/mL
Reading time
And
Interpretation
Reading time: 15 min
Myocardial tissue injury (AMI : Acute Myocardial
Infarction)
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CRP
LH M-ALB MGL PRL
Normal
values
Abnormal
values
FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
C-Reactive Protein (inflammatory process)
Reading time
And
Interpretation
Reading time: 10 min
Laboratories
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CRP
Reading time: 5 min
Doctors office
< 8 µg/mL
Parameters
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> 8 µg/mL
2.5 - 400 μg/mL Increase in :
- acute bacterial infection (300 - 350 µg/mL 80 85 % cases).
- acute viral infection (> 8 µg/mL and < 200
µg/mL).
- Inflammatory disorders (RA, rheumatic fever,
inflammatory bowel disease...).
-Tissue injury or necrosis (Myocardial infarction,
ischemia, rejection of kidney, marrow transplant,
malignant tumors, after surgery : peaks at 48 -72
hrs and falls to normal within 5 -7 days if no
complications).
Not increased in :
- Autoimmune diseases (SLE, scleroderma...)
- Pregnancy
- Strenuous exercise
- Angina
- Cerebrovascular accident
- Seizures
- Asthma
- Common cold
- Rejection of heart transplant.
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Parameters
D-DIMERS
Depends on
age, sex and
physiological
profile
LH M-ALB MGL PRL
Normal
values
Abnormal
values
> 400 ng/mL
FEU
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
D-Dimers (deep vein thrombosis)
< 400 ng/mL
FEU
FOB
Reading time
And
Interpretation
Reading time: 15 min
250 - 5000
ng/mL FEU
Increased levels in :
- Fibrinolysis
- During thrombolytic or defibrination therapy with
tissue plasminogen activator.
- Deep-vein thrombosis.
- Pulmonary embolism.
- Arterial thromboembolism.
- Disseminated intravascular coagulation.
- Vaso-occlusive crisis of sickle cell anemia.
- Pregnancy.
- Maligancy.
- Surgery.
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FOB
LH M-ALB MGL PRL
Normal
values
Abnormal
values
Blood in feces (colorectal cancer)
FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Reading time
And
Interpretation
Reading time: 10 min
(Faecal Occult
Blood)
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< 100 ng/mL
> 100 ng/mL
10 - 499 ng/mL Increase in :
- Colorectal cancer,
- Haemorrhoids,
- Stomach irritations,
- Ulcers.
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Parameters
FRT
LH M-ALB MGL PRL
Normal
values
Abnormal
values
Iron deficiency (anemia)
Male
12 - 300 ng/mL
Female
10 - 150 ng/mL
Children
(newborn)
25 -200 ng/mL
Children
(1 month)
200 - 600 ng/mL
Children
(2-5 months)
50 - 200 ng/mL
Children
(6 months-15
years)
7 - 142 ng/mL
Increased or
decreased levels
FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Reading time
And
Interpretation
Reading time: 15 min
10 - 630 ng/mL Increased levels in:
hemochromatosis, hemosiderosis, megablastic
anemia, hemytic anemia, alcoholic/inflammatory
hepatocellular disease, inflammatory disease,
Hodgkin's disease and breast cancer. > 80 ng/mL
essentially excludes iron deficiency.
Decreased levels in:
iron deficiency anemia, severe protein deficiency
hemodialysis.
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Parameters
FSH
LH M-ALB MGL PRL
Normal
values
Abnormal
values
< 2 IU/L
> 2 IU/L
Males (Adults)
1 -10 IU/L
> 10 IU/L
Females
(Prepuberty)
< 2 IU/L
> 2 IU/L
Females
(Follicular
phase)
1 - 10 IU/L
> 10 IU/L
Females
(Midcycle)
6 - 30 IU/L
> 30 IU/L
Females
(Luteal phase)
1 - 8 IU/L
> 8 IU/L
Females
(Postmenopausal)
20 - 100 IU/L
> 100 IU/L
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Follicle stimulating hormone (menopause)
Males
(Prepuberty)
FOB
5 - 400 IU/L
Reading time
And
Interpretation
Reading time: 10 min
Increase in :
- Primary hypogonadism (anorchia, testicular
failure, menopause)
- Gonadotropin-secreting pituitary tumors
- Complete testicular feminization syndrom
- Luteal phase of menstrual cycle.
Decrease in :
- Secondary hypogonadism
- Pituitary FSH deficiency
- Gonadotropin deficiency.
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H-CG
week 1
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LH M-ALB MGL PRL
Normal
values
Abnormal
values
25 – 100 I/UL
week 2
50 – 1 000 I/UL
week 3
100 – 5 000 I/UL
week 4
600 – 9 000 IU/L
week 6
1 600 – 100 000
week 8
6 000 – 200 000
month 2 to 3
20 000 - 300 000
2nd trim
9 500 – 92 000
3rd trim
6 000 – 50 000
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Human chorionic gonadotropin (pregnancy)
< 5 IU/L
FOB
5 - 1000 IU/L
Reading time
And
Interpretation
Reading time: 15 min
Increase in:
- Pregnancy
- Ectopic pregnancy (Beta-hCG)
- Hydatidiform mole of the uterus (Beta-hCG)
- Choriocarcinoma of the uterus, testes or ovaries
(Beta-hCG).
Decrease in:
- Threatened abortion
- Incomplete abortion
- Dead fetus.
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IgE
LH M-ALB MGL PRL
Normal
values
Immunoglobulines E (allergy)
< 150 IU/mL
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Abnormal
values
> 150 IU/mL
FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Reading time
And
Interpretation
Reading time: 10 min
10 - 800 IU/mL - Diagnosis of E-myelomas
-Indicates various parasitic or allergic diseases. A
normal IgE level excludes the diagnosis of
bronchopulmonary aspergillosis.
Increased levels in:
- Exogenous asthma (60%)
- Hay fever (30%)
- Atopic eczema.
-Parasitic diseases (ascarisis etc...)
Decreased levels in:
- Hereditary deficiencies
- Acquired immunodeficiency
- Ataxia-telangiectasia
- Non-IgE myeloma.
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INSULIN
Adult
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LH M-ALB MGL PRL
Normal
values
Abnormal
values
> 20 µU/mL
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Insulin hormone (diabetes, insulinoma)
< 20 µU/mL
FOB
Reading time
And
Interpretation
Reading time: 15 min
5 - 200 μU/mL
Not clinically useful for diagnosis of diabetes
mellitus. Useful for diagnosis of insulinoma.
Increase in :
- Insulinoma
- Factitious hypoglycemia
- Insulin autoimmune syndrome
- Untreated obese patients with mild diabetes
- Patients with acromegaly
- Reactive hypoglycemia after glucose ingestion.
Absent in :
- Severe diabetes mellitus with ketosis and weight
loss.
Normal in :
- Hypoglycemia associated with nonpancreatic
tumors
- Idiopathic hypoglycemia of childhood except
after administration of leucine.
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LH
LH M-ALB MGL PRL
Normal
values
Abnormal
values
FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Luteinizing hormone
Reading time
And
Interpretation
Reading time: 10 min
(in serum)
Menus
Adult females 4 – 30 UI/L
(menstruating)
Adult females 14 – 18 UI/L
(midcycle)
Parameters
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Increased or
5 - 200 IUL
decreased levels
Increase in :
- Primary hypogonadism
- Luteal phase of menstrural cycle
Decrease in :
- Secondary hypogonadism
- Pituitary LH deficiency
- Gonadotropin deficiency
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M-ALB
LH M-ALB MGL PRL
Normal
values
Abnormal
values
Menus
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FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Albumin in urine (diabetes)
< 20 mg/L (urine) > 20 mg/L (urine)
FOB
Reading time
And
Interpretation
Reading time: 10 min
2.5 - 5000
μg/mL
Increase in :
- Diabetes mellitus
- Chronic and acute renal disease.
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MGL
LH M-ALB MGL PRL
Normal
values
Parameters
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> 80 ng/mL
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Myoglobin (acute myocardial infarction)
< 80 ng/mL
Menus
Abnormal
values
FOB
Reading time
And
Interpretation
Reading time: 15 min
50 - 500 ng/mL Increased levels in :
- Myocardial infarction (earlier marker of AMI)
- Skeletal muscle inflammatory (myositis)
- Malignant hyperthermia.
- Muscular dystrophy
- Skeletal muscle ischemia
- Rhabdomyolysis.
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Parameters
PRL
LH M-ALB MGL PRL
Normal
values
Abnormal
values
Prolactin hormone (lactation)
Adult male
< 20 ng/mL
Adult female
0 - 20 ng/mL
Pregnant
female
20 - 400 ng/mL
> 20 ng/mL
/
FOB
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Reading time
And
Interpretation
Reading time: 10 min
20 - 350 ng/mL - 40 - 85 ng/mL : seen in craniopharyngioma,
hypothyroidism, effect of drugs.
- 50 ng/mL : 25 % chance of a pituitary tumor.
- 100 ng/mL : 50 % chance of a pituitary tumor.
- 200 - 300 ng/mL : 100 % chance of a pituitary
tumor.
Other causes of increased levels:
- Amenorrhea/galactorrhea
- Hypothalamic lesions
- Other endocrine diseases.
- Pregnancy
- Liver failure
- Idiopathic causes.
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PSA
LH M-ALB MGL PRL
Normal
values
Abnormal
values
< 4 ng/mL
> 4 ng/mL
Male > 70
years
< 6.5 ng/mL
> 6.5 ng/mL
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Prostate Specific Antigen (prostate cancer)
Male < 70
years
FOB
1 - 100 ng/mL
Reading time
And
Interpretation
Reading time: 10 min
Increase in :
- Cancer,
- Prostatitis,
- Benign prostatic hypertrophy,
- Acute urinary retention.
Decrease in:
- Ejaculation within 24 - 48 hours,
- Castration,
- Use of antiandrogen drugs,
- Radiation therapy,
- Prostactectomy,
- PSA falls 17 % in 3 days for patient lying in
hospital bed.
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Parameters
TRP I
LH M-ALB MGL PRL
Normal
values
Abnormal
values
< 0.8 ng/mL
> 0.8 ng/mL
(whole blood)
< 1.0 ng/mL
> 1.0 ng/mL
FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Troponin I (Acute myocardial infarction)
(plasma/
serum)
FOB
Reading time
And
Interpretation
Reading time: 20 min
0 - 50 ng/mL
The most specific marker of acute myocardial
infarction (AMI).
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TSH
LH M-ALB MGL PRL
Normal
values
Abnormal
values
/
> 5.0 mIU/L
Possible
/
< 0.10 mIU/L
0.10 - 0.29
mIU/L
/
hyperthyroidism
Parameters
Borderline
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FRT
FSH HCG IgE
PSA TRP-I TSH
EASY
READER
measuring
range
Thyro Stimulating Hormone (Hypothyroidism)
Possible
hypothyroidism
FOB
2 - 80 mIU/L
Reading time
And
Interpretation
Reading time: 15 min
Increase in:
- Primary untreated hypothyroidism
- Patients with Hashimoto's thyroiditis
- Use of various drugs (Iodine containing drugs,
dopamine antagonists).
- Neonatal period
- Thyrotoxicosis due to pituitary thyrotroph
adenoma.
Decrease in:
- Hyperthyroidism
- Acute psychiatric illness
- Severe dehydration
- Drug effect
- First trimester of pregnancy.
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technical data
Useful
recommendations
Questions
Answers
Maintenance
Error messages
Troubleshooting
Reader
technical data
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Display range:
Qualitative results (negative or positive)
Sample material:
Whole blood, plasma, serum or urine samples
Display:
LCD-Display 2 x 24 characters
Printer:
Thermal paper printer, roll width 54 mm
Memory capacity:
28 results
Dimension:
200 x 200 x 70 mm
Weight:
822 g without power supply unit, 1104 g with power supply unit
Power supply:
7.5 V DC with power supply unit (100-240 V ~)
Consumption :
8W
Optimal working
temperature:
+15 C to +30 C
Relative humidity:
< 95%
Storage and transportation
conditions (reader):
-10 to +60 C, < 95% humidity
EMC compatibility:
This instrument is EMC-tested and fulfils requirements of guidelines
EN 61326:1997, 55022, 61000-3-2/-3, 61000-4-2/-3/-4/-5/-6/-11.
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recommendations
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Useful recommendations for more accurate
results during test processing
1) Switch on the reader and wait for 5 minutes to let it warm up.
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2) Place the cassette horizontally (sample well on the left-hand side)
and add the sample (whole blood, plasma or serum) in the exact
position as indicated in the picture by the arrow.
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recommendations
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Useful recommendations for more accurate
results during test processing
3) When using whole blood sample,
wait for the complete absorption of
the sample (less than a minute). This
is very important to get a clear
background.
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4) Add four (4) drops of diluent
without the bottle tip touching the
cassette.
Useful
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Useful recommendations for more accurate
results during test processing
5) Keep the bottle vertical in order to
always obtain the right volume of
drops while adding the diluent into the
sample well.
Parameters
Questions
6) Push the cassette firmly into the
reader.
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7) Read exactly the result at the appropriate time indicated in the
instruction leaflet corresponding to the tested parameter.
Useful
recommendations
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8) Please make sure that test cards will always be well
placed in the correct position into the card holder.
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Maintenance
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The reader does not require regular maintenance. With normal usage,
the device will not become dirty. The surface of the meter can be cleaned
with a slightly moistened, soft cloth. Please strictly avoid any liquid
penetrating into the meter. If needed, the black test card holder can be
completely pulled out of the meter and be cleaned with tap water.
Disinfection using isopropanol is possible. Please make sure that the test
card holder is completely dry before putting it back into the meter.
To obtain good and consistent results, you should note the
following:
a) Do not expose the instrument to direct sunlight or severe temperature
fluctuations.
b) Set up the instrument in humidity-free conditions.
c) Always keep the test card holder dust and dirt free.
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Error messages
E04
WRONG CODEKEY
A wrong version of E-prom (chip) is inserted into the slot. Switch off the
reader. Remove the chip and replace it with an E-prom of the right
version. Switch on the reader.
E05
NO CODEKEY
Reader internal error. Not possible to repair by the user.
Please contact your supplier immediately.
E06
SAMPLE INVALID
The reader has detected an abnormal reaction on the test card.
Perhaps the sample was haemolytic or the test card was defective.
Repeat the measurement with a new test card.
E10
WRONG POSITION
Position of test card in the meter is not correct. Check whether the test
card was placed in the meter in the right position following the arrow
(sample well () and not in the opposite direction. Also check that it is
fully inserted into the slot (until locked).
E14
User memory full
The maximum memory capacity (28 results) is reached; every further
examination will cause the deletion of the oldest result.
E14
User memory empty
No results stored. Therefore, no stored results can be shown.
E20
WRONG DATE
Wrong date programmed. Please make sure that the entered date is
correct.
E22
CALIBRATION ERROR
The reader has detected a wrong internal calibration. Please switch off
device and then switch on again. Please set a new zero line with the
blank device.
E23
PRINTER ERROR
The reader has detected an internal printer error. Please check the
correct paper position. Switch off meter and then on again. If the
problem persists, please contact your supplier.
E25
EXTERNAL LIGHT
Optical compounds have recorded too much external light. Please avoid
positioning the reader in too intensive external light (e.g. sunlight,
halogen beamer) towards the card holder opening.
E28
BLANK/OPTIC FAULT
Zero line setting was not accepted. Please try again as per the
instructions. If the problem persists, please contact your supplier.
E30
WRONG FORMAT
Wrong format. Please follow the advice shown on the display. Repeat
this step.
Questions
Answers
No output to screen.
Troubleshooting
a. Check that the Easy Reader® is plugged into the electrical supply.
b. Check the position of on/off button. It should be positioned on “ON”.
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Message on screen :
E25 : EXTERNAL LIGHT
Interference due to external light. The reader should be repositioned
to avoid direct light.
Message on screen :
E28 : BLANK/OPTIC FAULT
The device used to perform “Blank strip” operation is not a true blank
device.
Message on screen :
E06 : SAMPLE INVALID
Test bands are not detected by the camera :
a. Blank device has been read.
b. The sample has not correctly migrated on the membrane (no
Control line). The test is non valid.
c. The test device has not been well positioned in the reading slot or
has not been pushed in enough.
No print
a. Check the “Settings” menu to verify whether the printer has been
deactivated.
b. Check that the paper is correctly positioned in printer as described
in MD-361018 Part IX (General instructions leaflet).
The printing quality is not
correct.
Clean the printer (printing heads are probably dusty) using a soft
brush.
Expected results are not
correct.
a. Blank operation has not been performed using a true blank device.
b. Test device has been reversed or has not been pushed completely
into the reading slot.
Date and Time are not
correct.
Check “Settings” menu and set the Date and Time parameters to the
correct values.
Commands are blocked and
forbid the use of the reader.
E-prom not designed for this version. Switch off the reader and try
again. If still blocked, the reader must be returned to VEDALAB.
Results for check card are
rendered as 2 values not 3.
The parameter to be assayed is a 2 line parameter. Only a few
parameters (hCG, CRP, Micro -Albumin) will show 3 values for the
check card.
Message on screen :
E 04 : WRONG CODEKEY
Check the inserted E-prom. The E-prom version is not designed for
C version reader.
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