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Parameters

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Ed. 2012/02
www.vedalab.com veda.lab@wanadoo.fr Next page
The VEDALAB EASY READER is an innovative meter for
reading immunochromatographic rapid test cards using a
Home high-resolution CCD-camera and integrated software
created for analysing pictures.
Start The EASY READER has a removable chip containing all
the necessary software for rendering quantitative or semi-
quantitative results from the test lines absorbance values.
Menus Depending on the tested parameter, results can be obtained
from whole blood, plasma, serum or urine samples.
Parameters 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
Questions
analysis.
Key Features of the VEDALAB EASY READER
Back
Key Features of the tests

End Principle of the reaction

Principle of the reader


Key Features

Home of the VEDALAB EASY READER


- Compact, light (1Kg) and convenient
Start - Fast, simple, easy and cost effective assays
- No need of a batch or product specific code chip (common blank and
calibration cards)
Menus
- Built-in printer
- Possibility to perform assays on the reader without any computer
Parameters connection
- Possibility to connect the reader to computer for increased memory
storage capacity.
Questions
- Possibility to connect the reader a barcode reader
- No need additionnal controls
Back
- No service contract required
- Wide range of available parameters
End
- High output: 60 samples per hour ( up to 120 without printing mode)
Next page
Key Features

Home of the tests


- Reagents stable at room temperature
Start - No need of a batch specific code chips
- No dilution of samples needed in most of the cases
Menus - 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
Questions - Fast results (5 – 20 minutes)
- Most of the tests could be run with very reduced amount of
Back sample ( 50µL of whole blood or 25µL of serum/plasma)

End

Next page
Principle of the reaction

Home 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
Start directly proportionnal to the concentration of the analyte.

Positive result

Menus 2 line parameter

Parameters sample
conjugate
Nitrocellulose
membrane 3 line parameter

Questions
1st test 2nd test Control
line line line

Back
Negative result

End
sample
conjugate
Nitrocellulose
membrane
Next page
Principle of the reader

Home The VEDALAB EASY READER is based on quantitative


immunochromatographic technology by measuring the intensity of the
reaction on a test cassette.
Start The CCD camera of Easy reader can measure the colour intensity and
determine the concentration of analytes in a sample.

Menus CCD
camera

Parameters

Questions
Quantitative
or
Back qualitative result

End
Home

Simplified
Start Detailed presentation
procedure

Kit composition
Menus
Connection
Changing E-prom
Parameters
Changing paper
Check
Questions
Assay procedure
Immediate or countdown mode
Back
Inserting the test card
Results and printing
End
Simplified
procedure

1) Place the instrument under non-corrosive environmental conditions,


Home on a flat, even surface that is free of dust, water (or any liquid) and
strong vibrations.
2) Install the required E-prom
Start
3) First connect the keyboard to the reader
4) Connect the reader to a power source
Menus
5) Press the switch on the back of the reader to start using it.
6) Press the "Start" button
Parameters
7) Select the parameter (only for multi-parameter E-prom)
8) Input the patient’s data needed to identify the sample via the keyboard
Questions
9) Perform the assay procedure as indicated in the leaflet of the
measured parameter.
Back 10) Select “immediate” or “countdown” mode
11) Insert the test card into the meter
End 12) Read the result
Detailed presentation Kit composition

Home
- Easy reader
- Electrical cords
Start (adapter and adapter cord)
- Keyboard
- E-prom
Menus
- Thermal paper roll
- Calibration device
Parameters - Blank device
- Instructions for use
Questions

Not in box but required to perform a test:


Back
- Timer
- Gloves, alcohol wipes and bandages
- Lab pipettes and tips
End
Connection
Detailed presentation Connection

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).
Home IF NOT, DO NOT CONNECT THE INSTRUMENT!

Start 1 First connect the keyboard to 4


the reader by inserting the
keyboard cord into the connector 5
labelled “KEYBOARD” at the back
Menus of the reader. 2 1
Connect the supplied adapter cord to the
2
Parameters connector labelled “7.5 V . 3A” at the back
of the reader.

3 Connect the other end of the adapter


Questions cord into the output connector of the
adapter.
Keyboard
4 Plug the male end of the adapter 3
Back cord into a grounded outlet with the
appropriate voltage.

End 5 Press the switch on the back of the


reader to start using it.
Changing the E-prom
Detailed presentation Changing the E-prom

For the proper functioning of the EASY READER®, an E-prom (chip)


Home
must be installed in the meter.
Each E-prom (chip) contains the calibration data specific to each
parameter or a range of several parameters.
Start The following instructions describe how to replace a chip.

Menus Before changing the E-prom, switch the reader off

Parameters

Questions

1. Open the 3. Remove the 4. Replace with the


Back
protective cover. E-prom. required E-prom.

2. Lift up the
End paper roll
Changing paper
Detailed presentation Changing paper

Please open the blue lid of the printer. A little section on the right hand side
Home 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
Start hand. If you can not manage this properly, it is possible to activate the
linefeed using display menu.

Paper input
Menus

Paper output
Parameters

Questions
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
Back
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.
End
Check
Detailed presentation Check

Home
This step allows the control of the meter with a
calibration device (check-card). Please read
carefully the insert sheet for the calibration step,
Start to be properly informed. On the check-card
package are indicated the appropriate limits of
tolerance for meter results.
Menus
After selecting Check on the main menu, you will
be asked to insert the blank device to set the
Parameters baseline. Please follow the instructions.
It is recommended to check the meter before
starting the measurements. This process should
Questions be performed once a week to verify that the
optical system of the reader is well calibrated.

Back

This step is necessary to allow exact measurements.


End
Assay procedure
Detailed presentation Assay procedure

Home CAUTION!
Please perform the assay procedure as indicated in
the leaflet of the measured parameter.
Start Useful recommendations

Selecting Start means activating the real measuring menu.


Menus
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
Parameters new zero line setting is necessary, please follow the reader
instructions.
After successful zero line setting (or if such a process was
Questions 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 .
Back

End
Assay procedure p.2
Assay procedure
Detailed presentation
Useful recommendations
Page 1 P.2 P.3 P.4

Home Useful recommendations for more accurate


results during test processing
1) Switch on the reader and wait for 5 minutes to let it warm up.
Start

Menus

Parameters
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.
Questions

Back

End
Assay procedure p.2
Assay procedure
Detailed presentation
Useful recommendations
P.1 Page 2 P.3 P.4

Home Useful recommendations for more accurate


results during test processing
3) When using whole blood sample,
Start wait for the complete absorption of
the sample (less than a minute). This
is very important to get a clear
Menus background.

Parameters
4) Add four (4) drops of diluent
without the bottle tip touching the
Questions cassette.

Back

End
Assay procedure p.2
Assay procedure
Detailed presentation
Useful recommendations
P.1 P.2 Page 3 P.4

Home Useful recommendations for more accurate


results during test processing
5) Keep the bottle vertical in order to
Start
always obtain the right volume of
drops while adding the diluent into the
sample well.
Menus

Parameters

6) Push the cassette firmly into the


Questions reader.

Back
7) Read exactly the result at the appropriate time indicated in the
instruction leaflet corresponding to the tested parameter.
End
Assay procedure p.2
Assay procedure
Detailed presentation
Useful recommendations
P.1 P.2 P.3 Page 4

Home Useful recommendations for more accurate


results during test processing
8) Please make sure that test cards will always be well
Start
placed in the correct position into the card holder.

Menus

Parameters

Questions

Back

End
Assay procedure p.2
Detailed presentation Assay procedure p.2

Home Please input the family name and first name of the patient via
the keyboard. End the input by pressing the ENTER-button.

Start

Menus

Parameters

Questions

Back

End
Assay procedure p.3
Detailed presentation Assay procedure p.3

Home Please input the date of birth in the requested format. End the
input by pressing the ENTER-button. Slashes will be generated
automatically .
Start

Menus

Parameters

Questions

Back

End
Immediate or countdown
Detailed presentation Immediate or countdown mode

Immediate
Home
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.
Start

Menus

Parameters
Countdown
The Countdown mode can be used in case the test has not been
Questions 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
Back 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
End sample (whole blood, serum, plasma, urine).
Inserting the test card
Detailed presentation Inserting the test card

Home
Insert the test card into the card
holder with the sample well ()
Start in the opposite direction of the
meter. Checking of chemical
reaction time and result
Menus measurement will be performed
automatically. Information will
appear on the display.
Parameters

Questions 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
Back 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”.
Home

Result is
Start expressed in the
unit system
compatible with
Menus the measured
parameter.

Parameters

Questions

Back 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”.

End After having processed the test, the cassette should be considered
potentially infectious and should be discarded accordingly.
Home

Start

Menus

Parameters

Questions

Back

After switching on, this screen appears a few seconds. Then the main menu appears
End automatically on the display (click on the slide to see the next one).
Home

Start

Menus

Parameters

Questions

Back

Click on the black buttons on the front of the reader to see information for « Start »
End « Check » or « Settings ».
Start
parameter

Home

Start

Menus

Parameters

Questions

Back

Available only with the multi parameter E-prom


End
Start
parameter

Home

Start

Menus

Parameters

Questions

Back

Available only with the multi parameter E-prom


End
Start
parameter

Home

Start

Menus

Parameters

Questions

Back

Available only with the multi parameter E-prom


End
Start
parameter
Blankcard

Home

Start

Menus

Parameters

Questions

Back

A control is automatically done in order to check whether there is a current zero line
End 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

A control is automatically done in order to check whether there is a current zero line
End 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

Menus

Parameters

Questions

Back

End (click on the slide to see the next one)


Start
parameter
Blankcard
Patient Name

Home

Start

Menus

Parameters

Questions

Back

Input the patient’s data (family name and first name ) needed to identify the sample via
End the keyboard. End the input by pressing the ENTER-button.
Start
parameter
Blankcard
Patient Name Birthday

Home

Start

Menus

Parameters

Questions

Back

Input the day of birth in the requested format. End the input by pressing the ENTER-
End button. Slashes will be generated automatically.
Start
parameter
Blankcard
Patient Name Birthday
Reading selection
Home

Start

Menus

Parameters

Questions

Back

-By pressing Immediate, the test result will be read immediately without any countdown.
End -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
Patient Name Birthday
Reading selection Countdown
Home

Start

Menus

Parameters

Questions

Back

Select the sample type either serum/plasma/urine or whole blood by pressing the
End corresponding button.
Start
parameter
Blankcard
Patient Name Birthday
Reading selection Countdown
Home
New test

Start

Menus

Parameters

Questions

Back

End (click on the slide to see the next one)


Start
parameter
Blankcard
Patient Name Birthday
Reading selection Countdown
Home
New test

Start

Menus

Parameters

Questions

Back

Remove the blank card before inserting a new test in the slot.
End (click on the slide to see the next one)
Start
parameter
Blankcard
Patient Name Birthday
Reading selection Countdown
Home
New test

Start

Menus

Parameters

Questions

Back

The test card is inserted directly into the meter after adding the
End 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
Patient Name Birthday
Reading selection Countdown
Home
New test

Start

Menus

Parameters

Questions

Back

The reader will automatically calculate the reaction time before the result measurement.
End (click on the slide to see the next one)
Start
parameter
Blankcard
Patient Name Birthday
Reading selection Countdown
Home
New test
Result
Start

Menus

Parameters

Questions

Back

The test result will be shown automatically and will be printed silmutaneously, if the
End printer is “ON”.
Result is expressed in the unit system compatible with the measured parameter.
Start
parameter
Blankcard
Patient Name Birthday
Reading selection Countdown
Home
New test
Result
Start Readout

Menus

Parameters

Questions

Back

By selecting Readout, the result can be shown line by line at display, if the printer is
End “OFF”.
Start
parameter
Blankcard
Patient Name Birthday
Reading selection Immediate
Home
New test

Start

Menus

Parameters

Questions

Back

End (click on the slide to see the next one)


Start
parameter
Blankcard
Patient Name Birthday
Reading selection Immediate
Home
New test

Start

Menus

Parameters

Questions

Back

Remove the blank card before inserting a new test.


End (click on the slide to see the next one)
Start
parameter
Blankcard
Patient Name Birthday
Reading selection Immediate
Home
New test

Start

Menus

Parameters

Questions

Back

The immediate reading mode can be used only if the test has
End 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
Patient Name Birthday
Reading selection Immediate
Home
New test

Start

Menus

Parameters

Questions

Back

End (click on the slide to see the next one)


Start
parameter
Blankcard
Patient Name Birthday
Reading selection Immediate
Home
New test
Result
Start

Menus

Parameters

Questions

Back

The test result will be shown automatically and will be printed silmutaneously, if the
End printer is “ON”.
Result is expressed in the unit system compatible with the measured parameter.
Start
parameter
Blankcard
Patient Name Birthday
Reading selection Immediate
Home
New test
Result
Start Readout

Menus

Parameters

Questions

Back

By selecting Readout, the result can be shown line by line in the display, if the printer is
End “OFF”.
Check
Blankcard

Home

Start

Menus

Parameters

Questions

Back

Insert the blank device to set the baseline. Please follow the
End 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

Insert the blank device to set the baseline. Please follow the
End 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

Remove the blank card before inserting the check card in the slot.
End (click on the slide to see the next one)
Check
Blankcard
Checkcard

Home

Start

Menus

Parameters

Questions

Back

This process should be performed once a week to verify that the


End 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

Compare the obtained results with the expected values (limits of tolerance) of the
End calibration device.
These values are printed on the calibration device pouch label.
Settings

Home

Start

Menus

Parameters

Questions

Back

End
Settings
User address

Home

Start

Menus

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

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

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
Output

Home

Start

Menus

Parameters

Questions

Back

End
Settings
Output
Display

Home

Start

Menus

Parameters

Questions

Back

End
Settings
Output
Display
Date/Time

Home

Start

Menus

Parameters

Questions

Back

Adjust the date and the time using the three buttons on the front of the reader.
End Click “next” to go back to the main menu.
Settings
Output
Display
Language

Home

Start

Menus

Parameters

Questions

Back

Selecte the appropriate language. Click “next” to go back to the main menu.
End
Settings
Output
Display
Language

Home

Start

Menus

Parameters

Questions

Back

End
Settings
Output
Print/Send

Home

Start

Menus

Parameters

Questions

Back

End
Settings
Output
Print/Send
Printer

Home

Start

Menus

Parameters

Questions

Back

There is a possibility of switching the printer reader ON or OFF.


End
Home

Start

Menus

Parameters

Questions

Back

Using the button below OFF or ON will bring the printer into the requested mode and
End then will lead to the appearance of the main menu.
Settings
Output
Print/Send
Printer
Linefeed
Home

Start

Menus

Parameters

Questions

Back

Here you can start the linefeed (Start) and stop it (Stop).
End 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

The memory contains a maximum of 28 results. Entering more than 28 results (new
End 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

Please give a two-digit input of a number between 01 and 28 on the display using the
End keyboard.
When entering 01 the last result will be shown.
Settings
Output
Print/Send
Memory
OK
Home

Start

Menus

Parameters

Questions

Back

By choosing No or Quit, you will return to the main menu.


End By choosing Yes, the printing process will start.
Settings
Output
Print/Send
Memory
OK
Home
Yes

Start

Menus

Parameters

Questions

Back

End
Home

Start

Menus

Parameters Simplified list Detailed list

AFP FOB LH TSH


Questions
CA125 FRT M-ALB

CEA FSH MGL


Back
CK-MB HCG PRL

CRP IgE PSA


End
D-Dimers Insulin TRP-I
Simplified list
Parameters Quantitative determination Reading EASY READER
time (min) measuring range
AFP Alpha feto protein (tumor marker) 10 10 - 300 ng/mL

CA -125 Antigen 125 (Ovarian cancer) 15 15 - 750 IU/mL


Home CEA CarcinoEmbryonic Antigen (tumor marker) 15 5 - 250 ng/mL

CKMB Creatine Kinase MB (Acute myocardial infarction) 15 5 - 200 ng/mL


Start
CRP C-Reactive Protein (inflammatory process) 5 or 10 2.5 - 400 μg/mL

D-DIMERS D-Dimers (deep vein thrombosis) 15 250 - 5000 ng/mL FEU

Menus FOB
(Faecal Occult
Blood in feces (colorectal cancer) 10 10 - 499 ng/mL

Blood)
FRT Iron deficiency (anemia) 15 10 - 630 ng/mL

Parameters 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

Questions 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

Back 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

End TRP I Troponin I (Acute myocardial infarction) 20 0 - 50 ng/mL

TSH Thyro Stimulating Hormone (Hypothyroidism) 15 2 - 80 mIU/L


Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
AFP Alpha feto protein (tumor marker) Reading time: 10 min
Adult < 40 ng/mL > 40 ng/mL 10 - 300 ng/mL - Testicular teratocarcinomas (75%)
- Pancreatic cancers (23%)
Menus
- Gastric cancers (18%)
- Cronchogenic cancers (7%)
- Colon cancers (5%)
Other diseases as:
Child < 30 ng/mL > 30 ng/mL - Viral hepatitis (24%)
- Postnecrotic cirrhosis (24%)
Parameters (<1 year) - Laennec's cirrhosis (15%)
- Primary biliary cirrhosis (5%).

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
CA -125 Antigen 125 (Ovarian cancer) Reading time: 15 min
Adult < 35 IU/mL > 35 IU/mL 15 – 750 IU/mL - Use in monitoring of epithelial ovarian cancer
treatment.
Menus
- May be also elevated in patients with cervical,
fallopian tubes and uterine cancer and
endometriosis.

Parameters

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
CEA CarcinoEmbryonic Antigen (tumor marker) Reading time: 15 min
< 5 ng/mL > 5 ng/mL 5 - 250 ng/mL Increase in :
- Colon, stomach, pancreas, lung cancers (75 %)
Menus
- 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,
Parameters obstructive jaundice.
- Renal failure
-Fibrocystic disease of breast.

Other factor of CEA increased levels:


- 19 % of heavy smokers and 7 % of former
Questions smokers have CEA > 5 ng/mL.

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
CKMB Creatine Kinase MB (Acute myocardial infarction) Reading time: 15 min
< 10 ng/mL > 10 ng/mL 5 - 200 ng/mL Myocardial tissue injury (AMI : Acute Myocardial
Infarction)
Menus

Parameters

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
CRP C-Reactive Protein (inflammatory process) Reading time: 10 min
Laboratories
CRP Reading time: 5 min
Menus Doctors office
< 8 µg/mL > 8 µg/mL 2.5 - 400 μg/mL Increase in :
- acute bacterial infection (300 - 350 µg/mL 80 -
85 % cases).

Parameters
- 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,
Questions 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...)
Back - Pregnancy
- Strenuous exercise
- Angina
- Cerebrovascular accident
- Seizures
End - Asthma
- Common cold
- Rejection of heart transplant.
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
D-DIMERS D-Dimers (deep vein thrombosis) Reading time: 15 min
Depends on < 400 ng/mL > 400 ng/mL 250 - 5000 Increased levels in :
FEU FEU ng/mL FEU - Fibrinolysis
age, sex and
Menus
- During thrombolytic or defibrination therapy with
physiological tissue plasminogen activator.
profile - Deep-vein thrombosis.
- Pulmonary embolism.
- Arterial thromboembolism.
- Disseminated intravascular coagulation.
Parameters - Vaso-occlusive crisis of sickle cell anemia.
- Pregnancy.
- Maligancy.
- Surgery.

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
FOB Blood in feces (colorectal cancer) Reading time: 10 min
(Faecal Occult
Blood)

Menus < 100 ng/mL > 100 ng/mL 10 - 499 ng/mL Increase in :
- Colorectal cancer,
- Haemorrhoids,
- Stomach irritations,
- Ulcers.

Parameters

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
FRT Iron deficiency (anemia) Reading time: 15 min
Male 12 - 300 ng/mL Increased or 10 - 630 ng/mL Increased levels in:
decreased levels hemochromatosis, hemosiderosis, megablastic
Female 10 - 150 ng/mL
Menus
anemia, hemytic anemia, alcoholic/inflammatory
Children 25 -200 ng/mL hepatocellular disease, inflammatory disease,
(newborn) Hodgkin's disease and breast cancer. > 80 ng/mL
essentially excludes iron deficiency.
Children 200 - 600 ng/mL
(1 month) Decreased levels in:
Parameters Children 50 - 200 ng/mL
iron deficiency anemia, severe protein deficiency
hemodialysis.
(2-5 months)
Children 7 - 142 ng/mL
(6 months-15
Questions years)

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
FSH Follicle stimulating hormone (menopause) Reading time: 10 min
Males < 2 IU/L > 2 IU/L 5 - 400 IU/L Increase in :
(Prepuberty) - Primary hypogonadism (anorchia, testicular
Menus
failure, menopause)
Males (Adults) 1 -10 IU/L > 10 IU/L
- Gonadotropin-secreting pituitary tumors
< 2 IU/L > 2 IU/L - Complete testicular feminization syndrom
Females - Luteal phase of menstrual cycle.
(Prepuberty)
Females 1 - 10 IU/L > 10 IU/L Decrease in :
Parameters (Follicular
phase)
- Secondary hypogonadism
- Pituitary FSH deficiency
- Gonadotropin deficiency.
Females 6 - 30 IU/L > 30 IU/L
(Midcycle)

Questions Females
(Luteal phase)
1 - 8 IU/L > 8 IU/L

Females 20 - 100 IU/L > 100 IU/L


(Postmenopausal)

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
H-CG Human chorionic gonadotropin (pregnancy) Reading time: 15 min
week 1 < 5 IU/L 25 – 100 I/UL 5 - 1000 IU/L Increase in:
- Pregnancy
week 2 50 – 1 000 I/UL
Menus
- Ectopic pregnancy (Beta-hCG)
100 – 5 000 I/UL - Hydatidiform mole of the uterus (Beta-hCG)
week 3 - Choriocarcinoma of the uterus, testes or ovaries
week 4 600 – 9 000 IU/L (Beta-hCG).

week 6 1 600 – 100 000 Decrease in:


Parameters week 8 6 000 – 200 000
- Threatened abortion
- Incomplete abortion
month 2 to 3 20 000 - 300 000 - Dead fetus.

2nd trim 9 500 – 92 000

Questions 3rd trim 6 000 – 50 000

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
IgE Immunoglobulines E (allergy) Reading time: 10 min
< 150 IU/mL > 150 IU/mL 10 - 800 IU/mL - Diagnosis of E-myelomas
-Indicates various parasitic or allergic diseases. A
Menus
normal IgE level excludes the diagnosis of
bronchopulmonary aspergillosis.

Increased levels in:


- Exogenous asthma (60%)
- Hay fever (30%)
Parameters - Atopic eczema.
-Parasitic diseases (ascarisis etc...)

Decreased levels in:


- Hereditary deficiencies
- Acquired immunodeficiency
Questions - Ataxia-telangiectasia
- Non-IgE myeloma.

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
INSULIN Insulin hormone (diabetes, insulinoma) Reading time: 15 min
Adult < 20 µU/mL > 20 µU/mL 5 - 200 μU/mL Not clinically useful for diagnosis of diabetes
mellitus. Useful for diagnosis of insulinoma.
Menus Increase in :
- Insulinoma
- Factitious hypoglycemia
- Insulin autoimmune syndrome
- Untreated obese patients with mild diabetes
Parameters - Patients with acromegaly
- Reactive hypoglycemia after glucose ingestion.

Absent in :
- Severe diabetes mellitus with ketosis and weight
loss.
Questions
Normal in :
- Hypoglycemia associated with nonpancreatic
tumors
- Idiopathic hypoglycemia of childhood except
Back after administration of leucine.

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
LH Luteinizing hormone Reading time: 10 min
(in serum)
Adult females 4 – 30 UI/L Increased or 5 - 200 IUL Increase in :
Menus (menstruating) decreased levels - Primary hypogonadism
- Luteal phase of menstrural cycle
Adult females 14 – 18 UI/L
(midcycle) Decrease in :
- Secondary hypogonadism
- Pituitary LH deficiency
Parameters - Gonadotropin deficiency

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
M-ALB Albumin in urine (diabetes) Reading time: 10 min
< 20 mg/L (urine) > 20 mg/L (urine) 2.5 - 5000 Increase in :
μg/mL - Diabetes mellitus
Menus - Chronic and acute renal disease.

Parameters

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
MGL Myoglobin (acute myocardial infarction) Reading time: 15 min
< 80 ng/mL > 80 ng/mL 50 - 500 ng/mL Increased levels in :
- Myocardial infarction (earlier marker of AMI)
Menus - Skeletal muscle inflammatory (myositis)
- Malignant hyperthermia.
- Muscular dystrophy
- Skeletal muscle ischemia
- Rhabdomyolysis.
Parameters

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
PRL Prolactin hormone (lactation) Reading time: 10 min
Adult male < 20 ng/mL > 20 ng/mL 20 - 350 ng/mL - 40 - 85 ng/mL : seen in craniopharyngioma,
hypothyroidism, effect of drugs.
Adult female
Menus
0 - 20 ng/mL - 50 ng/mL : 25 % chance of a pituitary tumor.
- 100 ng/mL : 50 % chance of a pituitary tumor.
Pregnant 20 - 400 ng/mL /
- 200 - 300 ng/mL : 100 % chance of a pituitary
female tumor.

Parameters Other causes of increased levels:


- Amenorrhea/galactorrhea
- Hypothalamic lesions
- Other endocrine diseases.
- Pregnancy
Questions - Liver failure
- Idiopathic causes.

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
PSA Prostate Specific Antigen (prostate cancer) Reading time: 10 min
Male < 70 < 4 ng/mL > 4 ng/mL 1 - 100 ng/mL Increase in :
years - Cancer,
Menus Male > 70 < 6.5 ng/mL > 6.5 ng/mL - Prostatitis,
years - Benign prostatic hypertrophy,
- Acute urinary retention.

Parameters Decrease in:


- Ejaculation within 24 - 48 hours,
- Castration,
- Use of antiandrogen drugs,
Questions - Radiation therapy,
- Prostactectomy,
- PSA falls 17 % in 3 days for patient lying in
hospital bed.

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
TRP I Troponin I (Acute myocardial infarction) Reading time: 20 min
(plasma/ < 0.8 ng/mL > 0.8 ng/mL 0 - 50 ng/mL The most specific marker of acute myocardial
serum) infarction (AMI).
Menus (whole blood) < 1.0 ng/mL > 1.0 ng/mL

Parameters

Questions

Back

End
Detailed list

AFP CA-125 CEA CKMB CRP D-DIMERS FOB FRT FSH HCG IgE

INSULIN LH M-ALB MGL PRL PSA TRP-I TSH

Home Parameters Normal Abnormal EASY Reading time


values values READER And
measuring Interpretation
range
Start
TSH Thyro Stimulating Hormone (Hypothyroidism) Reading time: 15 min
Possible / > 5.0 mIU/L 2 - 80 mIU/L Increase in:
hypothyroidism - Primary untreated hypothyroidism
Menus - Patients with Hashimoto's thyroiditis
- Use of various drugs (Iodine containing drugs,
dopamine antagonists).
Possible / < 0.10 mIU/L - Neonatal period
hyperthyroidism
- Thyrotoxicosis due to pituitary thyrotroph
Parameters adenoma.

Decrease in:
Borderline 0.10 - 0.29 / - Hyperthyroidism
mIU/L - Acute psychiatric illness
Questions - Severe dehydration
- Drug effect
- First trimester of pregnancy.

Back

End
Home

Start

Menus

Parameters

Reader Useful Questions


Questions
technical data recommendations Answers
Maintenance
Back
Error messages
Troubleshooting
End
Reader
technical data

Display range: Qualitative results (negative or positive)


Home
Sample material: Whole blood, plasma, serum or urine samples

Display: LCD-Display 2 x 24 characters


Start Printer: Thermal paper printer, roll width 54 mm

Memory capacity: 28 results

Menus 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 ~)


Parameters Consumption : 8W

Optimal working +15 C to +30 C


temperature:
Questions
Relative humidity: < 95%

Storage and transportation -10 to +60 C, < 95% humidity


Back conditions (reader):
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.
End
Useful
Page 1 P.2 P.3 P.4
recommendations

Home Useful recommendations for more accurate


results during test processing
1) Switch on the reader and wait for 5 minutes to let it warm up.
Start

Menus

Parameters
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.
Questions

Back

End
Useful
P.1 Page 2 P.3 P.4
recommendations

Home Useful recommendations for more accurate


results during test processing
3) When using whole blood sample,
Start wait for the complete absorption of
the sample (less than a minute). This
is very important to get a clear
Menus background.

Parameters
4) Add four (4) drops of diluent
without the bottle tip touching the
Questions cassette.

Back

End
Useful
P.1 P.2 Page 3 P.4
recommendations

Home Useful recommendations for more accurate


results during test processing
5) Keep the bottle vertical in order to
Start
always obtain the right volume of
drops while adding the diluent into the
sample well.
Menus

Parameters

6) Push the cassette firmly into the


Questions reader.

Back
7) Read exactly the result at the appropriate time indicated in the
instruction leaflet corresponding to the tested parameter.
End
Useful
P.1 P.2 P.3 Page 4
recommendations

Home Useful recommendations for more accurate


results during test processing
8) Please make sure that test cards will always be well
Start
placed in the correct position into the card holder.

Menus

Parameters

Questions

Back

End
Questions Maintenance
Answers

Home
The reader does not require regular maintenance. With normal usage,
the device will not become dirty. The surface of the meter can be cleaned
Start 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.
Menus Disinfection using isopropanol is possible. Please make sure that the test
card holder is completely dry before putting it back into the meter.

Parameters
To obtain good and consistent results, you should note the
following:
Questions a) Do not expose the instrument to direct sunlight or severe temperature
fluctuations.
b) Set up the instrument in humidity-free conditions.
Back c) Always keep the test card holder dust and dirt free.

End
Questions Error messages
Answers
E04 A wrong version of E-prom (chip) is inserted into the slot. Switch off the
WRONG CODEKEY reader. Remove the chip and replace it with an E-prom of the right
version. Switch on the reader.
Home E05 Reader internal error. Not possible to repair by the user.
NO CODEKEY Please contact your supplier immediately.
E06 The reader has detected an abnormal reaction on the test card.
SAMPLE INVALID Perhaps the sample was haemolytic or the test card was defective.
Start Repeat the measurement with a new test card.
E10 Position of test card in the meter is not correct. Check whether the test
WRONG POSITION 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).
Menus E14 The maximum memory capacity (28 results) is reached; every further
User memory full examination will cause the deletion of the oldest result.
E14 No results stored. Therefore, no stored results can be shown.
Parameters User memory empty
E20 Wrong date programmed. Please make sure that the entered date is
WRONG DATE correct.
E22 The reader has detected a wrong internal calibration. Please switch off
Questions CALIBRATION ERROR device and then switch on again. Please set a new zero line with the
blank device.
E23 The reader has detected an internal printer error. Please check the
PRINTER ERROR correct paper position. Switch off meter and then on again. If the
problem persists, please contact your supplier.
Back E25 Optical compounds have recorded too much external light. Please avoid
EXTERNAL LIGHT positioning the reader in too intensive external light (e.g. sunlight,
halogen beamer) towards the card holder opening.
E28 Zero line setting was not accepted. Please try again as per the
End BLANK/OPTIC FAULT instructions. If the problem persists, please contact your supplier.
E30 Wrong format. Please follow the advice shown on the display. Repeat
WRONG FORMAT this step.
Questions Troubleshooting
Answers
No output to screen. 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”.
Home Message on screen : Interference due to external light. The reader should be repositioned
E25 : EXTERNAL LIGHT to avoid direct light.
Message on screen : The device used to perform “Blank strip” operation is not a true blank
E28 : BLANK/OPTIC FAULT device.
Start Message on screen : Test bands are not detected by the camera :
E06 : SAMPLE INVALID a. Blank device has been read.
b. The sample has not correctly migrated on the membrane (no
Control line). The test is non valid.
Menus 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
Parameters in MD-361018 Part IX (General instructions leaflet).
The printing quality is not Clean the printer (printing heads are probably dusty) using a soft
correct. brush.

Questions 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 Check “Settings” menu and set the Date and Time parameters to the
correct. correct values.
Back Commands are blocked and E-prom not designed for this version. Switch off the reader and try
forbid the use of the reader. again. If still blocked, the reader must be returned to VEDALAB.
Results for check card are The parameter to be assayed is a 2 line parameter. Only a few
rendered as 2 values not 3. parameters (hCG, CRP, Micro -Albumin) will show 3 values for the
End check card.
Message on screen : Check the inserted E-prom. The E-prom version is not designed for
E 04 : WRONG CODEKEY C version reader.

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