SBM IDRA User manual

User Manual
IDRA

2
INTRODUCTION 3
SYMBOLS 4
CARES, WARNINGS AND GENERAL SAFETY ADVICES 5
Ordinary maintenance 5
Transport, storage conditions and terms of use 6
THE INSTRUMENT 6
Spare parts 6
Accessories 7
Supply package 7
SOFTWARE ICP USER MANUAL 8
Software installation 8
First use 10
GUIDE OF USE 10
Functional features 10
MAIN USE 11
HOME SCREEN 12
Create a new patient 12
New exam 13
MAIN EXAMS 14
ADDITIONAL EXAMINATIONS 15
Pupillometry 16
GENERIC EXAM 18
EXAMS LIST 19
Display exams related to a patient 19
Type of saved exams 19
BUTTONS 20
TROUBLESHOOTING 21
TECHNICAL AND ELECTRICAL FEATURES 21
Minimum hardware requirements 22
TEST RESULTS 22
Measurement of emission 22
Radiated Emission Peak 23
Immunity test 24
Radiated Electromagnetic Immunity 24
Immunity to RF wireless communication equipment 25
Power frequency magnetic fields immunity test 26
SUMMARY OF TESTS RESULTS 26
SETTINGS 27
Using ICP as a viewer 29
DISPOSAL POLICY 30
LIABILITY 30
WARRANTY AND CONTACTS 31
CERTIFICATION AND DECLARATION OF CONFORMITY 31
INDEX

3
INTRODUCTION
Thank you for purchasing the IDRA of SBM Sistemi S.r.l.
All our products have been manufactured with the greatest attention to safety. The IDRA, code 15011, is
a high-performance instrument. To use eciently and safely the instrument, please read carefully this
manual before installing and using the instrument and follow all warnings in it and outside the
equipment. Even in the case of operators who have used this device before, check again the instructions in
this manual.
Keep this manual carefully for future reference.
Description and intended use
The IDRA is characterized by the homonymous medical device and the software ICP for Windows. Through
the connection of the device to your pc (fixed or portable), it allows to do the exams related to the analysis
and possible diagnosis of Dry Eye Disease (DED), and particularly
• Interferometry:records a video to the patient’s eye to analyze quantitatively and qualitatively lipid layer of
the tear film, to compare it with the related grading scale and save the value;
• Tearmeniscus: takes a picture (directly from the Interferometry video, or using the voice “TearMeniscus”),
through the automatic centering of the device it allows to measure the quantity of aqueous layer in
millimeters and to save the value;
• NIBUT: recording a video, it allows to evaluate the stability of the tear film between the break up time in a
non-invasive way and to save the value.
• Auto-NIBUT: it is possible to measure break up time of the tear film through the automatic NIBUT.
• BUT: records a video for the evaluation of the tear film’s stability, but it is done with instillation of
the fluorescein in the patient’s eye (invasive) and without cone;
• Meibography: takes a picture of meibomian glands using infrared light. The device can analyze
automatically the loss area of the glands to compare it with the related grading scale;
• Additional exams: checks for blepharitis, Demodex, pupillometry, corneal deformation, WTW, generic exam.
All the exams that can be performed with the IDRA are of fundamental importance for the ophthalmologist
and the optometrist (within their respective professional skins) to study the tear film and for coaching the
exams done with the classic instruments (Slit Lamp, Topography, Tonometry, etc.).
© 2018 SBM Sistemi S.r.l. All rights reserved.
All other products and company names are trademarks of their respective owners.
Rev.01 02/03/18

4
SYMBOLS
Warning
Read carefully the operating instructions before use
Medical device according to Directive 93 / 42 / EEC and subsequent amendments
Device WEEE to separately dispose
Keep away from moisture
Manufacturer info according to Directive 93 / 42 / EEC and
subsequent amendments
Device number reference
Device serial number
Handle with care / Upward
Fragile
Transport and storage conditions (temperature / humidity / pressure)
© 2018 SBM Sistemi S.r.l. All rights reserved.
All other products and company names are trademarks of their respective owners.
REF
SN

5
CARES, WARNINGS AND GENERAL SAFETY ADVICES
Created and developed 100% in Italy.
Medical device IDRA registered in Class I at the Ministry of Health according to Directive EN 60601- 1.
Risk class: A.
The product subject of this manual is a medical device according to Directive 93/42/ECC and subsequent
amendments.
Warning:
• Verify possible damage resulting from transport before using the instrument.
• Handle with care lighting system and pay attention to the edges of the object.
• Never touch the power supply cable with wet hands; check that the same will not being walked or
pinched by weights; not tie it.
• A damaged power supply cable may cause fire or electric shock. It should be checked frequently.
In case you need to replace the power supply cable included with the unit, contact the supplier.
• Do not make any technical intervention on the device or system that does not belong to the provisions
of this manual.
• Do not use this equipment near liquids and gases, and be careful not to spill liquids in any point
of the device.
Avoid humid, dusty places or places subject to rapid changes in temperature and humidity.
• Before cleaning and / or disinfecting the device, disconnect it from the power source.
• The device must not touch the patient.
• A long exposure to strong light can damage the retina, the use of the device for ocular examination must
not last unnecessarily.
Assistance
If you encounter any problem with the software or the device, please contact SBM SISTEMI S.r.l. or the
supplier company. They will take care of the necessary technical assistance.
Ordinary maintenance
The repairs described below must all be performed with the power supply disconnected from the battery
socket. For any other type of fault presented that cannot be solved with the interventions described below,
please contact the installer.
Protection from dust
When the instrument remains unused, store it in the suitcase or in the packing provided to protect it from
dust. The dust accumulated on the eyepiece and on the lenses aimed at observation during use must be
removed periodically using a soft cloth and a rubber bellows. For cleaning external surfaces, simply use a
cloth slightly moistened with water. Do not use diluents or solvents.
Other precautionary measures
Extraordinary maintenance operations (repairs, components replacement, internal parts verification, etc.)
are the sole responsibility of the technical assistance service of SBM SISTEMI S.r.l.
Before sending the instrument back to SBM SISTEMI S.r.l. for repairs or maintenance, clean the surface with
a clean cloth moistened with water.

6
Transport, storage conditions and terms of use
The instrument in its original packaging, may be exposed to the following environmental conditions without
being damaged, for a maximum period of 15 weeks during shipment and storage:
•Temperature between -10 ° C and +60 ° C;
•Atmospheric pressure between 500 hPa and 1060 hPa; relative humidity between 10% and 90%.
The environmental terms of use are as follows:
• Temperature between +15 ° C and +45 ° C;
• Atmospheric pressure between 700 hPa and 1060 hPa; relative humidity between 30% and 75%.
THE INSTRUMENT
Fig. 1
Spare parts
If you damage some parts of the device, it is possible to contact the supplier to replace them, for example:
• External or internal parts of the shell
• Main cone and Placido cone
• Pin
• Circuits
• Cables
• Camera
• Foot pedal
MAIN BLACK CONE
MAIN CONE
CAMERA LENS YELLOW FILTER
PIN
SHELL
LOGO
SCREWS

7
Accessories
The purchase of IDRA provides for the availability of various accessories, the use of them is essential or
recommended. Between these:
• A cone with placid disc
• Foot pedal to record videos/take pictures
• IDRA support applicable to the working table
• Suitcase to store the device to protect and transport it
Supply package
The instrument is delivered in a packaging. In the suitcase are inserted required accessories and essential
documents to use IDRA. Please check if there are the following components:
• IDRA medical device subject of this manual
• Quick guide
• USB key for software ICP for Windows
• Activation code
• Foot pedal
• Suitcase
LOGO

8
SOFTWARE USER MANUAL
SOFTWARE INSTALLATION
The installation and configuration process of IDRA Software consist of the installation of the software files
through the Setup provided by the supplier.
1. Execute Setup file
2. Start the software to download the ICP application on the PC.
3. Wait for the end of procedure
4. Wait for the application opening at the end of installation.
5. At the opening of application will appear the activation procedure:

9
You must be connected to internet in order to activate the application.
• If you do not have an ID and password of SBM Sistemi Account you must tap “New Registration”, fill in
all the fields and tap the “Send” button. Once you make your new registration is important KEEP your ID
and PASSWORD chosen in the above procedure, in order to activate other applications available from
supplier.
• If you have ID and password of SBM Sistemi Account, select “Already registered” button and sign in the
system.
Once you register your application with one of the two methods mentioned above, you have to wait for
activation provided by your supplier or enter the code if provided by the same.
Data protection code (Fig. 2)
For added security, you can set a code that you enter each time you sign in the application or wake up from
background mode, preventing use by unauthorized personnel.
Set code at activation of the application:
Immediately after the application is activated you will be asked to set a 4 digit security code. If left empty,
the code will be disabled by pressing the “OK” button, otherwise set the unlock code and confirm the
choice.
Editing security code:
Select “Menu” button in the bar on the right top of the home screen. Then Settings > Reset password code
and follow the instruction given.
Warning: keep in secure storage the set code, because in case it is lost you will not be longer able to
access data.
Fig. 2

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First use
After having installed the software, to be able to use the diagnostic tool IDRA it is necessary to connect
the two USB cables to the computer (fixed or portable) as follows:
• USB 3.0 blue cable corresponds to the camera of the device and it must be connected to pc through the
related entry to can use the best quality allowed by the IDRA,
• USB 2.0 white cable must be connected to pc without any specific detail,
• To use foot pedal, it is necessary to have another USB port (2.0 or 3.0).
The device must be inserted in the support between slit lamp and biomicroscope (Fig. 4).
Its pin has been built in order to fit perfectly into the hole that you can see when the plate
used for the tonometer is removed.
GUIDE OF USE
Do the patient have a seat comfortably using the chin holder and support for the front: in this way the
patient stands still and the practitioner is accurate in carrying out the exams.
The IDRA must be kept as close as possible to the eye without touching. Closer is the device to the eye,
broader is the area lighted by the instrument. The light reflected from the tear film can be observed as a
white circular area that almost completely covers the cornea.
The observer system is placed to allow analysis through the central hole of the IDRA, through the tablet
screen.
The exams done with white leds require the use of the main cone to prevent all possible external and
internal reflections. The exams of Meibomian glands, B.U.T. and Demodex require to remove this cone as
follows
1) Turn around the inserted cone
2) Then, remove the cone to detach from the magnets
Functional Features
The device IDRA is the result of a long period of research done with the most accredited professionals,
to give the highest combination between technical innovation, quality and design. As already mentioned,
the main operating characteristics of the instrument are:
• Analysis of lipid layer
• Height of tear meniscus
• Evaluation of stability and regularity of the tear film
• Evaluation of Meibomian glands in the upper and lower eyelids.
Fig. 4

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MAIN USE
Lipid layer examination
Through the device it is possible to do an interferometric analysis of the lipid layer in the tear film.
The tear film plane must be focused, while the image of the bright circle must remain blurred.
Depending on its thickness and regularity, the lipid layer may appear like any of the following: amorphous
structure, marble appearance, wavy appearance, yellow, brown, blue or reddish interference fringes.
Height of the inferior tear meniscus
Most tears are collected in the inferior and superior tear meniscus. The size of the tear meniscus formed on
the eyelid borders provides useful information on the volume of tears produced. The tear meniscus can be
examined considering its height, regularity and shape. Gradation is not accurate when there are reflected
tears. IDRA’s brightness is calibrated so as not to cause any glare in the patient examined; besides, the light
being cold it does not induce excessive reflected lachrymation.
IDRA allows you to highlight shape and height of the tear meniscus without using any staining, hence
without altering tear composition.
A standard tear meniscus is convex near the eyelid margin and concave at the center. The standard tear
meniscus, observed with IDRA, presents with a typical black line near the convex part of the meniscus
profile.
Tear film stability and regularity
IDRA allows to evaluate stability and regularity of the tear film, using non-invasive break up time
measurement (NIBUT). In fact, the appropriate cone can be inserted inside IDRA’s to project structured
images on the tear film surface. By examining the regularity of the image reflected by the tear film the tear
film NIBUT can be measured. The non-invasive break up time is the measurement, in seconds, of the time
between the last complete blinking and the appearance of the first discontinuity on the tear film. The device
can also be used to observe the pre-rupture phase indicating tear film thinning time.
For accurate measurement, the patient must be properly instructed. During the exam, the patient must look
in front of him/her and is encouraged to slightly blink. Then ask to the patient to keep his/her eyes open,
without blinking for as long as possible. The seconds between the last full blinking and the first rupture of
the image reflected on the tear film are counted with a chronometer.
Meibography
Through IDRA you can evaluate the Meibomian Glands thanks to infrared image analysis. It allows you to
evaluate the quantity of glands overall palpebral area.
Once evaluated the exam, the software will give you the 3D shape of glands to understand in which areas
there is a loss.

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HOME SCREEN
The “Home” screen give you access to the main features of the application, allowing full management
of patient and his/her condition (Fig. 5).
Tapping this button will appear the main initial screen divided as follows:
• On the top you have the patients list with their information,
• On the bottom you have the details of the selected patient and the summary of all the exams done.
Fig. 5
On the bottom it is possible to look at general and specific information of the selected patient.
A) It provides to consult the patient’s condition based on the exams done.
B) It allows you to watch the summary of the values saved after having done the exams with the IDRA
(“Dry Eye”).
C) It allows you to watch single values related to each type of examination (N.I.B.U.T., B.U.T., Interferometry,
MGD, Tear Meniscus)
D) You can also access to the voices O.S.D.I, Osmolarity and LipCof, in which it is possible to add values
related to these examinations done with the appropriate external devices.
E) Moreover, the section “Pupillometry” let you know which the values of pupillometry are in scotopic,
mesopic and photopic vision done with the IDRA
Warning: by pressing any “delete” button will lost your data in a permanent and no more recoverable way.
Warning: whenever appear a warning message on the screen of the device, read everything carefully
before losing it.
Create a new patient
The first operation that the ICP software allows to perform, immediately after installation, is to create a new
patient using the “Add patient” button located at the down left .
Pressing this button, you will see a section for entering patient information. Will also appear the space for
any notes.
“Exams” tab connects to the screen with all examinations carried out and related to the selected patient.
If the patient has just been added, the two screens (left and right) will be empty.
If the patient already has exams done, on the left there is a list of the various types of exams with a number
in brackets, which indicates the number of acquisitions in the sub-category. Pressing on one of these items,
on the right the binocular examination screen opens and at the bottom the preview of all the acquisitions of
the selected category is presented.

13
Fig. 6
In this way all the acquisitions are grouped: the unprocessed ones have the relative obscured scale, while in
the elaborated ones the evaluation scale is colored and contains a value (result).
It’s possible to add , delete an exam result and also create a pdf that shows the results of the exams
done.
Warning: delete an exam result, it means that will be deleted permanently and no longer recoverable.
“Note” tab displays the agreement on the handling of personal data and its acceptance by the signature of
the patient, through the button . In addition you can add any information about the patient’s exam.
New exam
Tapping “New Exam” button on the top, it is possible to start a new screening exam for the patient choose.
Please choose a patient before proceeding with a new exam creation.
In this section will be highlighted the IDRA interface that will allow you to make dierent main exams:
• Interferometry
• Tear Meniscus
• B.U.T. Exam
• N.I.B.U.T. Exam (manual and automatic)
• Meibography.
Selecting each examination will appear on the right the instrument specifications required and a brief
description of the exam chosen.
Tap the “Start” button located at the bottom right of the screen to start the examination.

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Tear meniscus (Fig. 8 - 8.1)
“In the image capture screen, take a photo of the patient’s eye
using the main cone. Focus on the lower tear meniscus moving
the base (you can understand to be on focus when you see the
black line on thear meniscus, which is the reflection of the iris).
Take the picture and close the acquiring screen with CLOSE on the
top. The software will bring to the exam view. Now, push on the
green button to analyse the exam.
You can choose to measure five dierent heights of thear
meniscus. (fig. 8.1). To do this, click on the numbers between
1 and 5 on the left side. After that, click with the mouse on the
borders of tear meniscus. When you have finished to measure, you
can choose to save one value selecting a number in “Result data”
section. If you prefer, you can also save the average of heights.
Then save with the floppy button on the top. To view the results,
go on patients section and choose “TEAR MENISCUS”.
MAIN EXAMS
Interferometry (Fig. 7)
Using the images capture screen, record a video of the patient’s
eye with the main cone inserted in the instrument and asking to
blink three-four times to the patient. To record a good video, go
on focus on the iris moving the base and then move backward of
2mm to focus properly on the LIPID LAYER (the iris will be not on
focus). The circle of light has to be around 5mm (it depends by the
distance from the eye). Now, you can record the video using the
red button on the left, or with the space bar, or with the foot pedal
included in the supply.
AUTO-N.I.B.U.T. (Fig.9)
In the capture screen, record a video (with red button, the space
bar or the foot pedal), removing the main cone and inserting the
Placido’s one (with concentric circles). Then push on start to do
exam. Go close as much as possible to the patient eye and use
the manual or auto focus to focus on the pattern projected on the
cornea (closer you are wider will be the projection).
With the evaluation button the software processes recorded video
to study automatically the break-up time, the number of blinks,
topography of the tear film and the graph to understand the trand
of all breakings (fig.9.1)
You will find on the top of the screen the 7 comparison categories
to start easily the analysis. If the fringes are white: compare the
exams with categories 1 to 4. If the fringes are colored (as shown
in the picture): compare the exam with categories 4 to 7. After
selecting the correspondent category, save with the disk on the
top right hand side.

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Meibography (Fig. 12)
Remove the cone to use infrared light only. In the
acquisition screen, take a picture of meibomian
glands turning the upper or lower eyelids with a
cotton but or the fingers (be sure that the lid is turned
and not just pulled down).
Move the instrument to get on focus to have a wider
view. Take the picture (with white button on left side,
with the space bar o with the foot pedal) and close
the actual screen with CLOSE.
(Fig. 12.1)
After taking the picture, select the green button on
the bottom right to process the image.
To perform the glands analysis, draw with the mouse
the lid area margins and press “>”. The detection of
the loss area is done automatically by the instrument.
Otherwise, it is possible to select semi- automatic or
manual detection. At the end of the procedure will
be shown the image with the lids and glands area
highlighted with red and green color (Fig. 12.1). Now
you can save the measure to return on the exams screen.
ADDITIONAL EXAMINATIONS
Fig. 11
Blepharitis (Fig. 13)
If you choose “Blepharitis” from the screen “New
Exam”, it’s possible to take a picture with white
lights by focusing on the eyelashes and the eyelid
rhyme. To take it, IDRA executes a magnification
that allows to study in a perfect way the situation.
The results can be compared with the right grading
scale.
B.U.T. (Fig. 10)
It is done with blue lights which turn on automatically
after selecting the exam. Remove the main cone to
light up completely the eyes and insert the yellow
filter (Fig.11). Then record a video asking the patient
to keep the eyes open for as long as possible.
Once you executed a B.U.T. examination you can
use the timer tool on the video playback screen to
calculate the break-up time of the tear film.

16
Corneal deformation
IDRA can also be used to assess the regularity of the corneal profile. By inserting the specific cone inside the
instrument, a series of concentric rings is projected onto the cornea. If the corneal surface is regular, the
concentric rings will all be at the same distance.
Any irregularities in the surface of the cornea will result in irregularities of the reflected image.
Pupillometry
The pupil measurement made by the IDRA has the objective to measure the pupillary diameter (in
millimeters) in three dierent conditions of lights. In fact the device can simulate the natural condition of:
• Photopic vision
• Mesopic vision
• Scotopic vision
By automatic led adjustment.
A summary of this collected results is accessible on the bottom of the main screen (“Pupillometry” Fig. 15).
Demodex (Fig. 14)
To take a picture and do this exam, you need you need
to remove cones. The device uses infrared lights which
allows to observe every possible movement of the
parasite.
If there is not Demodex, the eyelashes are clean
and you do not see any white movement. If there is
Demodex, you can observe a general inflammation
and most likely a blepharitis condition.
Fig. 15
Pupillometry examination has to be done without any cone inserted in the device.
It is possible to acquire three dierent images of both eyes, or to choose which images acquire by selecting or
deselecting the options provided in the exam opening screen “Pupillometry” (fig. 15 a).
With this exam it is also possible to measure WTW (white-to-white, so the diameter of iris).
Fig. 15 a

17
Follow strictly the instructions on the left side of the screen.
1) The acquisition will automatically start simulating SCOTOPIC light. It is necessary to ask the patient to look
inside the device, to focus four bright spots and center them with the reference circle (fig. 15 b).
Then, acquire the image through space bar or foot pedal.
2) After taking picture of eyes in scotopic vision, MESOPIC light will automatically turn on.
Follow instructions as in point 1.
3) Finally, PHOTOPIC light will switch on. Follow instructions as in point 1.
Now it’s possible to evaluate the acquisitions, following the instructions on the left:
1) with the first acquisition you obtain the pupillary diameter in scotopic vision and the diameter of the iris
(WTW).
Use the white cursors of two circles to align them with the iris edges and the pupil edges, then proceed as
shown in the software (fig. 15 c).
2) Now, elaborate the second image to have pupillary diameter in mesopic vision,
3) Finally, move white cursors in the third image positioning the circle on the pupillary edges to obtain pupillary
diameter in photopic vision.
Then, save the results.
Fig. 15 b
Fig. 15 c

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WTW
This test allows to measure the horizontal iris diameter from white to white (white to white).
Unlike pupillometry, this value remains constant over time.
Follow the instructions given in the “Pupillometry” section in point 1.
GENERIC EXAM
This option allows to use the device such as a digital slit lamp to study the anterior ocular segment.
It is possible to record videos, take pictures and choose the kind of lighting.
After doing generic exam (for example, to analyse bulbar redness), the software allows to compare it with
dierent international grading scales through the “Compare” button:
• Efron,
• CCLRU.
• JenVis
And to save the chosen category as a result.
In this way the generic acquisition becomes a real exam to save and print in the reports.

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EXAMS LIST
Display exams related to a patient
The exams saved list will be shown at the end of an exam or in the “Exams” section.
In this section it is also possible to edit and compare the exams through the selection of the chosen exam.
Fig. 16a
Type of saved exams
In the “Exams” section, on the left are all the acquisitions carried out and subdivided by type of exams, while
on the right the binocular display of the selected exam.
• Picture (Fig. 16a): selecting an exam, will appear its binocular preview on the right with different buttons
set under the image (full screen view, compare, zoom, drawing, result, processing of the image);
• Video (Fig. 16b): selecting a video, will start binocularly videos on the right. On the bottom there are play/
pause, full screen view, compare, result and processing of the selected video, while on the right there are
buttons to do a screenshot by the video and evaluate the tear meniscus directly by this video.
Fig. 16b
Add button
In this way, you can add an exam returning to the
main exams screen.
Delete button
To delete one by one examinations, you must to
select photo or video that you want to delete and
tap the “can” on the bottom left.
It is possible to delete more exams at the same time.
PDF button (Fig. 18)
It is possible to save or print dierent types of
reports on the computer:
the first group includes all the exams processed
on a specific date; the second allows to report a
binocular examination; the third concerns a single
monocular examination; finally it is possible to
save the graph report, useful for the follow-up of a
patient of all the exams carried out over time.
Fig. 17

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Modify button
Let you add a note related to the selected exam. In this way, the change will appear on PDF of the exam
when you will save it.
Compare Button
Let you compare the selected image or video with:
• Images/videos of the same patient,
• Images/video of other patients,
• International grading scales (CCLRU, Efron, Jenvis and Meibography).
BUTTONS
Timer Button
The “Timer” button start a timer on the device screen.
Auto Exposure Button
Tap the “Auto Exposition” button to set the choice of right quantity of light and to get a picture or a video
well exposed, automatically.
+/- ISO Button
Tap “+ ISO” or “- ISO” to manually manage the light exposure of the device camera.
Auto Focus Button
The “Auto Focus” button allows to obtain and maintain automatically focus on a subject.
+/- Focus Button
Tap “+ Focus” or “- Focus” to manually manage the focus on a subject.
White, blue and infrared light buttons
On the “Generic Exam” screen, tap the button related to the type of desired lighting to turn the LEDs on or o.
It is possible to modify the brightness of white, blue and red leds thanks to a column
correlated to their buttons. Moreover, in infrared light the device allows to choose
how many and which leds to choose (Fig. 19).
+/- Zoom Button
Tap “+ Zoom” or “- Zoom” to manually manage the zoom. Moreover, move closer or move away from the
patient to improve the focus.
Fig. 18