iCare MAIA Perimeters and Microperimeter User Manual

OPERATING MANUAL
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MANUAL INFORMATION
Date of release:
Revision number:
Reference software version:
Manufacturer:
June 12th, 2019
35_US
v2.6
CenterVue S.p.A.
Via San Marco 9/H, 35129 Padova – ITALY
Tel. +39 049 501 8399
Fax +39 049 501 8398
SUMMARY
1.
INTRODUCTION .................................................................................................................................................. 3
2.
SYSTEM .............................................................................................................................................................. 4
3.
LABELING ........................................................................................................................................................... 7
4.
SYMBOLS ............................................................................................................................................................ 9
5.
WARNINGS AND PRECAUTIONS ........................................................................................................................10
6.
PREPARING MAIA ..............................................................................................................................................12
6.1
Mounting and installing the Eye Occluder ....................................................................................... 12
7.
PREPARING THE SUBJECT ..................................................................................................................................14
8.
PERFORMING THE EXAM ...................................................................................................................................17
9.
REVIEWING RESULTS .........................................................................................................................................38
10. PRINTING ..........................................................................................................................................................53
11. SETTINGS ...........................................................................................................................................................55
12. REMOTE VIEWER ...............................................................................................................................................68
13. SYSTEM SHUTDOWN .........................................................................................................................................70
14. CLEANING..........................................................................................................................................................70
15. BASIC TROUBLESHOOTING ................................................................................................................................71
16. ELECTROMAGNETIC COMPATIBILITY .................................................................................................................72
17. TECHNICAL SPECIFICATIONS ..............................................................................................................................73
18. REFERENCE DATABASE ......................................................................................................................................75
19. PRECISION .........................................................................................................................................................77
20. DECOMMISSIONING AND DISPOSAL .................................................................................................................79
21. MAINTENANCE ..................................................................................................................................................80
APPENDIX A: MAIA grids XML format ........................................................................................................................82
APPENDIX B: RAW Data Export Tool ..........................................................................................................................84
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1.
INTRODUCTION
The Macular Integrity Assessment (MAIA) is a confocal, infrared, ophthalmoscope combined with a
system for visible light projection to obtain perimetric measurements, using “fundus perimetry”.
MAIA is indicated for measuring macular threshold sensitivity, fixation stability and the locus of
fixation, as well as providing infrared retinal imaging.
It also contains a reference database for the quantitative comparison of macular threshold sensitivity
to a database of normal subjects.
Intended users include eyecare practitioners, i.e. optometrists, ophthalmologists and trained eye
care technicians. The clinical interpretation of MAIA results is restricted to licensed eye care
practitioners.
MAIA is not meant to diagnose any disease: the process of making a diagnosis using MAIA is the
responsibility of the eye care practitioner.
A device specific training is required for any operator to become able to use the system. The intended
setting for the use of the device includes private practitioner’s offices, clinics, research facilities,
hospitals and educational facilities.
CAUTION:
CenterVue
US federal law restricts this device to sale by or on the order of a physician or a
properly licensed practitioner.
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2.
SYSTEM
MAIA - 2013 Edition (ATMARME002)
Forehead rest =
applied part
Chin rest =
applied part
Integrated touch
screen display
Fig. 1 – MAIA side view
The system is made of the following main components: optical head, touch-screen display,
instrument body, push-button, chin-rest, forehead-rest.
Fig. 2 – USB and Ethernet connectors, power inlet and main switch
Fig. 3 – Push-button = applied part
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Fig. 4 – Push-button plug
MAIA 2013 Edition is supplied with:
• power cord
• push-button
• lens cap
• spare fuses
• dust cover
• forehead-rest silicone pad
• Eye Occluder
• this operating manual
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MAIA - 2009 Edition (ADMITME001)
Forehead rest =
applied part
Chin rest =
applied part
Integrated
touch screen
display
Chin rest
adjustment knob
Joystick
Push-button =
applied part
Fig. 5 – MAIA front view
The system is made of the following main components: optical head, touch-screen display, joystick,
instrument body, push-button, chin-rest, forehead-rest.
Fig. 6 – USB and Ethernet connectors (left) / power inlet and main switch (right)
MAIA 2009 Edition is supplied with:
• power cord
• push-button
• lens cap
• spare fuses
• USB keyboard
• dust cover
• this operating manual
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3.
LABELING
MAIA - 2013 Edition
sn: xxxx
yyyy/mm
Class I laser product conforming with IEC 60825-1.
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MAIA - 2009 Edition
Class I laser product conforming with IEC 60825-1.
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4.
SYMBOLS
Symbols adopted in this manual.
Symbol
Explanation
Manufacturer Data
Manufacturing Date (year/month of production)
Electronic and electric devices must be recycled.
Refer to Instruction Manual
CE mark: the device complies with the essential requirements of the European
Medical Devices Directive 93/42/EC
Warning: Do Not Touch
Type B Applied Part
Generic Warning
Important information
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5.
WARNINGS AND PRECAUTIONS
The following precautions are particularly relevant to the device safety:
• CAUTION – Federal law restricts this device to sale by or on the order of a physician.
• The clinical interpretation of MAIA results is restricted to licensed eye care
practitioners.
• A device specific training is required for any operator to become able to use the
system.
• Do not open the device: this could lead to electric shocks or damage to the system.
• Do not use the instrument in the event that the cover or other parts of the device
have been removed.
• Only technicians authorized by CenterVue may service MAIA. CenterVue cannot be
held responsible for system safety should MAIA be opened, repairs carried out, third
parties software be installed, or parts be replaced by un authorized persons.
• Do not expose the device to water: this could lead to fire or electric shock.
• Stand clear from moving parts during operation.
• All parts in contact with a patient’s skin need to be disinfected after use (see par. 14).
• The instrument is supplied with an earth ground by means of a protection conductor
contained inside the power supply cable. To replace such cable, only use a cable
provided by CenterVue with current rating of 10A and conductor size of 1mm2. Before
turning on the system, make sure the power supply socket is correctly grounded to
avoid the risk of electric shock.
• The room where MAIA is operated must respect local or national safety standards
relative to medical use of a room or area, such as IEC or ISO safety standards.
• MAIA must NOT be used in an oxygen rich environment or in presence of flammable
anesthetics.
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The following precautions are particularly relevant to prevent use errors:
• Before performing any exam check that the push-button is functional by checking
that the “Button” indicator on screen turns orange when the button is clicked: If
the push-button is not functional no patient response will be detected and wrong
threshold values will be recorded.
• Before performing any exam check that the stimulus is projected at the center of
the central fixation target. The stimulus is automatically enabled when entering
the exam interface (pressing “New Fast/Expert Exam”). If the stimulus is not
centered the exam outcome will be unreliable.
• The device must be placed in a room which is not exposed to adverse chemicalphysical conditions, such as the presence of sulfur, salt, dust, direct sunlight, lack
of ventilation, high humidity, sudden temperature drops or peaks. The safety
and/or effectiveness of the instrument cannot be guaranteed if these conditions
are not fulfilled.
• MAIA needs to be operated under the following environmental conditions:
Temperature: 10°C - 40°C (50°F – 104°F) / Humidity (max): 90% not condensing
• MAIA needs to be stored under the following environmental conditions:
Temperature: -10°C – 60°C (14°F - 140°F) / Humidity (max): 90% not
condensing
• MAIA outcomes are not sufficient to identify a treatment option.
• Do not leave the front lens uncovered while the system is not in use.
The MAIA display is a touch screen panel: wherever this manual says “click on ..” it
means “point the finger on the display on ..”
This updated version of the Operating Manual mainly refers to MAIA – 2013 Edition.
Some of the features and components are available on only one of the two models and
are clearly indicated throughout the manual.
Due to the different resolution of the monitor of MAIA – 2009 Edition, some screenshots
might be slightly different than what can be seen (in terms of presence and position of
some buttons). However, if the related function is available in the 2009 Edition, it will
be easy to identify them.
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PREPARING MAIA
6.
We recommend to read carefully and thoroughly par. 5 - WARNINGS AND PRECAUTIONS
before proceeding with first use.
To make MAIA functional you need to:
• extract the system from its box;
• place it on a suitable electrical table1 (see dimensions at par. 17);
• connect the power cord provided with the unit to the power inlet (see Fig. 2 or Fig. 6);
• connect the push-button to the push-button connector (see Fig. 2 or Fig. 5): the push-button
is used by examined subjects during the test, as explained at par. 7, item 8;
• optionally connect the 3D joystick to any of the USB ports (see Fig. 2 or Fig. 6): the joystick
can be used to align the patient as a complement to the touch screen;
• optionally install the Eye Occluder (see Par. 6.1) [available for 2013 Edition only];
• optionally connect a compatible printer to any of the USB ports (see Fig. 2 or Fig. 6);
For the list of compatible printers please contact the manufacturer or visit
www.centervue.com
•
attach the silicone forehead-rest (included in the tool box) on the forehead-rest frame as
shown in the pictures below (Fig. 7 and Fig. 8) [available for 2013 Edition only];
Fig. 7 – Forehead-rest patient side
Fig. 8 – Forehead-rest rear side
The room where MAIA is operated shall remain in semi-darkness during the test, as direct light
sources hitting the front lens or a patient’s eye would affect the results.
6.1 Mounting and installing the Eye Occluder
The Eye Occluder is a device to be installed on MAIA forehead rest. It is to be used to mask
the contralateral eye during exam, as a non-invasive alternative to an eye-patch. Its use is
advisable when the environment can affect the concentration of the patient during exam
(e.g. other persons in the room), and the patient is not comfortable with keeping the
contralateral eye closed.
1 Not provided with MAIA
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The black screen is to be fixed to the mobile arm by two automatic buttons: always attach and
detach first the button on the short part of the arm, then the one on the long part (see Fig. 9 and
Fig. 10 ).
Fig. 9 – Mobile arm and black screen
Fig. 10 – Eye Occluder mounted
To install it, simply remove the silicone rest from the forehead rest, and assemble it on the side
opposite to the patient with the two provided screws and with the provided 2 mm Allen key, as
depicted in Fig. 11.
Fig. 11 – Eye Occluder installation
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The Eye Occluder shall be free to rotate from one eye to the other, passing over the top of the
head-rest, so not to interfere with patient’s nose (see Fig. 12).
Fig. 12 – Possible directions of rotation
Fig. 13 – Eye Occluder position
when examining the right eye
After the Eye Occluder is installed, the forehead rest can be installed over it. Always turn the Eye
Occluder to the contralateral eye before starting the exam (see Fig. 13).
The Eye Occluder is designed not to touch the patient during the exam. Anyway, if
needed, the black screen can be easily removed for disinfection. Multiple
replacement screens can be ordered as needed.
7.
PREPARING THE SUBJECT
This paragraph explains how to prepare a subject for the MAIA test. There are no restrictions as to
the selection of the subjects undergoing MAIA testing, but since the test requires the subject to
maintain concentration and follow the below instructions for several minutes, very young subjects
(before primary school) as well as mentally diseased persons may to not be able to co-operate
appropriately.
The subject should not wear spectacles while being examined, otherwise artifacts may appear in
the retinal image.
MAIA does not compensate for a subject’s astigmatism. Subjects with astigmatism within  4 diopters
can be tested normally. Testing a subject with astigmatism outside the above range may result in
inaccurate measurements.
MAIA compensates a subject’s spherical refractive error in the range -15 to +10 diopters: testing a
subject presenting a spherical error out of the above range may result in inaccurate measurements.
MAIA is a non-mydriatic device (minimum pupil diameter 2.5 mm), so there is no need to dilate the
subject.
Patient contacting parts are indicated in Fig. 1 and Fig. 3.
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The patient shall place his head over the chin-rest and his front in contact with the central part of
the forehead-rest. In order to have a faster retina detection in the alignment phase, the chin-rest
height shall be adjusted in order to have the patient’s eye aligned with the eye marker present on
the side of the forehead-rest support.
Before the test inform the subject about the following:
1) MAIA will test your ability to perceive light and look at a steady target;
2) the test is non-invasive, in particular the system will never touch your eye and you will only see
some red and white light;
3) do not move and maintain concentration throughout the test;
4) the test will last approx. 5 minutes per eye;
5) find a comfortable position, keeping the chin and forehead firmly pressed against the rests;
6) look for a small red circle inside the instrument and always keep fixating at its center;
Fig. 14 - fixation target as seen by the subject over the background
7)
8)
during the test you can blink;
you will be given a push-button: press it with the thumb should you see, or believe you see, a
whitish small spot appearing anywhere;
Fig. 15 – spot as seen by the subject over the background
9)
It is absolutely normal that you do not see many of the spots, so do not worry.
During the test:
• inform the subject when the test is about to start, following the initial alignment and setup;
• periodically inform the subject of the approximate time to completion;
• repeat recommendations 6) and 8);
• finally, inform the subject when the test is over.
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NOTES FOR THE OPERATOR
No specific clinical knowledge is required to operate MAIA. However, a device specific training is
required to use the system.
The operator needs to be acquainted with the following concepts:
• pupil: the central part of the external surface of the eye, through which light goes in;
• retina: the internal surface of the eye ball;
• macula: the central portion of the retina;
• fixation / fixating: the ability of a subject to stare at a specific point in space;
• optic disk: a specific portion of the retina characterized by a roughly circular shape and by
outgoing / incoming vessels;
• sensitivity threshold: the minimum intensity of a light stimulus that is perceived by a subject
as emerging from the background;
• alignment: the action of moving the top part of the system so that optics are aligned with a
subject’s pupil.
Fig. 16 - The optic disk (indicated by the black circle)
Acquaintance with the basic concepts of standard automated perimetry is helpful for
an effective use of some of the features of the MAIA device and for the interpretation
of its results.
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8.
PERFORMING THE EXAM
This paragraph explains how to operate MAIA to perform any of the available tests.
Turn the instrument on and wait until the software loads and the startup screen appears (see Fig.
17). The complete boot procedure takes approximately 1 minute.
Fig. 17 – Startup screen showing patients list
8.1
Projection System Checkup
MAIA Projection System is the internal device responsible of projecting the stimuli on the desired
positions of the retina depending on the test grid and the information coming from the Retina Tracking
System. It is suggested to check at least daily (see Par. 21 – Maintenance) that the Projection
System is correctly calibrated. At every boot, MAIA will request the operator to check the position of
the white stimulus and confirm that it is correctly positioned.
The operator shall look into the front lens and check that the center of the white dot is located inside
the external border of the fixation target (see Fig. 18 for a graphical representation), and press the
button corresponding to the outcome of the check.
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Fig. 18 – Projection System Check
If the Projection System Check fails please have your system verified by your
CenterVue Authorized Service Representative because the Projection System might
be out of calibration.
In this situation it is recommended not to perform any exam because its outcome would
be unreliable or inaccurate, as indicated by high Fixation Losses indexes in most
exams.
8.2 Adding a new patient
To add a new patient to the list, click on the NEW PATIENT button and type the last name, first name
and date of birth (see Fig. 17): these are all mandatory, while the gender selection is optional. A
unique numerical ID is automatically assigned to any new patient.
The assigned patient ID is unique but may not be persistent: in particular, it will change
when restoring a backup archive in APPEND mode (see par. 11.7).
The date format is the following throughout the software: YYYY-MM-DD.
MAIA incorporates a reference database for comparison of threshold results to agematched normal values: insertion of a wrong date of birth may result in the wrong color
coding of the result (see par 18).
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Fig. 19 – Patient demographics insertion screen
If a patient with the same Lastname, Firstname and Birthdate is already present in the system, a
warning message will inform the operator and ask whether to open the existing patient or to create
a duplicate (see Fig. 20).
Fig. 20 – Duplicate patient warning
Once created, the new patient’s record will open (see Fig. 21).
8.3 Selecting an existing patient
Click on any of the names appearing in the startup screen: the corresponding patient’s record will
open (see Fig. 21). The Search box can be used to search a specific patient by last or first name,
while the arrows in the header row allow to sort the list by ID, last name, date of birth or date of last
visit.
Fig. 21 – Patient Record screen
Once done, you are all set to sit the patient, provide all explanations described at par. 7 and proceed
with the test.
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8.4 Performing the exam
In the patient record screen, the following options are available:
•
NEW FAST EXAM:
The Fast Test has been developed to significantly reduce the examination time, as in suprathreshold perimetric tests. Only 2 intensities are tested: first at min intensity (27 dB) and then, if
not seen, at max intensity (25 dB), hence this test does not measure the actual threshold but
rather a supra-threshold response consisting of one of the following options: “seen at min
intensity”, “seen at max intensity”, “not seen at max intensity”.
The Fast test takes 2 to 3 minutes per eye and it is designed to quickly determine whether
macular sensitivity falls below or above the 90th and 95th percentile of a reference group of
normals (see reference database at par. 18), without determining the actual threshold. The Fast
Test also determines fixation stability and the preferred fixation site (PRL).
intensity
intensity
intensity
For a complete description of the outcomes of the Fast Test see par 9.
within
normal
limits
seen
seen
suspect
not
seen
time
not
seen
outside
normal
limits
not
seen
time
time
Fig. 22 – Fast test projection logic
•
NEW EXPERT EXAM: performs a complete assessment, determining macular threshold
sensitivity and fixation stability. Three threshold convergence strategies are available:
a. 4-2 strategy (default): a full-threshold test used to examine retinal sensitivity in detail.
b. Four Levels Fixed (4LF): this strategy has been developed to reduce the
examination time, as in suprathreshold perimetric tests. Only 4 intensities are tested
(0 dB, 5 dB, 15 dB and 25 dB), hence this test does not measure the actual threshold
but rather a supra-threshold response consisting of one of the following options: “not
seen at 0 dB”, “seen at 0 dB”, "seen at 5 dB", "seen at 15 dB", "seen at 25 dB".
This strategy can be used on patients presenting significantly reduced thresholds as
compared with reference values.
c. Scotoma Finder: this strategy has been developed to significantly reduce the
examination time, as in supra-threshold perimetric tests. Only one intensity is tested
(0 dB), hence this test does not measure the actual threshold but rather a suprathreshold response consisting of one of the following options: “seen at 0 dB”, “not
seen at 0 dB”.
This strategy can be used on patients presenting significantly reduced thresholds as
compared with reference values, including areas of absolute scotoma (i.e. unable to
perceive the 0 dB stimulus).
d. Fixation Only strategy: this strategy allows to collect only the fixation data measured
by the retinal tracking, without projecting any stimulus. The duration of the exam can
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be set at the beginning, from 10 sec. to 5 min., with 10 sec. steps. This strategy allows
to perform analysis on the fixation skills of the patient.
The 4-2 expert test takes 4 to 7 minutes per eye, while the 4-Levels Fixed test or the Scotoma
Finder test take about 1 to 4 minutes per eye.
For a complete description of the outcomes of the Expert Test see par.9.
Fig. 23 – Expert test projection logic (4-2 strategy)
Fig. 24 – Expert test projection logic (4-Levels Fixed strategy)
Fig. 25 – Expert test projection logic (Scotoma Finder strategy)
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•
NEW FOLLOW-UP EXAM (only available when an expert test was made): repeats the
baseline expert test by re-measuring the same points.
See here below for FAST or EXPERT exam, and par. 8.5 for FOLLOW-UP exam.
For a complete description of the outcomes of the different exam options, see Par. 9.
8.4.1 Checking push-button operation
After clicking on any of the 3 buttons listed above (new fast exam, new expert exam, or new followup), the test screen opens (see Fig. 28).
Before proceeding with the test, verify that the push-button is functional by checking that the “Button”
indicator on screen (see Fig. 26) turns orange when the button is pressed. This has to be repeated
before each exam session, also to check patient’s ability to operate the push-button.
If the push-button is not functional no patient response will be detected and wrong
threshold values will be recorded.
Fig. 26 - Push-button status indicator on screen by icon color: not pushed, pushed, unplugged
In MAIA 2013 Edition only, the software automatically detects whether the push-button is missing
or improperly plugged, and it warns about this situation with a message (see Fig. 27): in such a case
re-check proper connection by unplugging and fully plugging again the jack of the push button (see
Fig. 4).
Fig. 27 – Message for unplugged push-button
The pushbutton detection is a hardware feature missing in MAIA – 2009 Edition: as a
consequence, the owners of this model are strongly suggested to check that the pushbutton is
connected and working before starting any exam.
At this point it is also suggested to check the Projection System status by looking into
the front lens and checking the stimulus position (see Fig. 18).
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Fig. 28 - Test screen
8.4.2 Dark mode
As described in Par. 5, the MAIA test shall be performed in semi-darkness: in some environments
indirect light from MAIA display reflected by the environment could adversely affect this requisite. In
such a case, the operator can reduce the light diffused by MAIA display by clicking on the
Colors:Bright button (Fig. 28), which will toggle into Colors:Dark changing the screen background
to black as shown in Fig. 29, and also turning off the blue led inside the Joystick (Fig. 32).
Fig. 29 - Dark mode test screen
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8.4.3 Choosing the strategy
When performing an expert test it is possible to select the exam strategy by clicking on the threestate button “Strategy:”. The three available choices for strategy are:
• Strategy: 4-2
• Strategy: 4-Levels Fixed
• Strategy: Scotoma Finder
The default choice is the 4-2 strategy.
Comparison with reference values for index “Average Threshold” and index “Percent
Reduced Thresholds” are only available when using the 4-2 strategy with the default
10° stimulus grid (see par. 9.2).
Furthermore index “Average Threshold” is not available when using the 4-Levels-Fixed
and Scotoma Finder strategies.
8.4.4 Choosing the grid
When performing an expert test, it is possible to select the stimuli grid by clicking on the Select
Grid button (see Fig. 30). The default grid is the first one in the list (37 points, 10° macular coverage).
The following additional grids are available:
•
6° macular coverage, 37 stimuli: compared with the default grid, provides a higher resolution
measurement of a smaller region; the 3 stimuli rings are located respectively at 1°, 2° and
3° from the center;
•
20° macular coverage, 41 stimuli: provides measurement of the entire macular region;
•
“10-2”, 20° macular coverage, 68 stimuli: same grid as in the Humphrey 10-2 test; measures
more locations that the previous grid;
•
“Manual”: an empty grid used in conjunction with command Add/delete stimuli to create
custom perimetric grids that are specific for a certain patient.
The following combinations are available:
• choosing one of the predefined grids (including an empty one);
• possibility to set the center of the selected grid (by enabling the option Change Grid
Position). This option will prevent the grid to be automatically centered on the PRL;
• possibility to add “custom” points to the selected grid by locating them directly on the retinal
image (option Add/delete stimuli).
Changing any of the above options will result in a grid different from the default 10°
grid for which reference values are available, therefore no comparison indexes
(Average Threshold and Percent Reduce Thresholds) will be available.
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Fig. 30 – Grid selection screen (only available for expert test)
The 5 grids shown in Fig. 30 are the default grids coming with MAIA software. More custom grids
can be created as desired as .xml files.
The .xml file can be imported from a USB device using the “Import from USB” button and then can
be stored with the “Export to USB” button. If no custom grid is currently installed on the unit, the
“Export to USB” button stores a sample xml file called MaiaPatternsSample.xml, containing 2
sample grids and instructions on how to edit an XML to compose the desired testing grid. For further
details on how to edit an XML file to create a MAIA grid, please refer to APPENDIX A: MAIA grids XML
format.
Please note that only the custom grids can be exported (not the 5 default grids); similarly,
when importing new grids you will be asked if you want to append them or to overwrite your
custom grids: if “overwrite” is selected, only the custom grids will be replaced by the ones
contained in the .xml file, leaving the 5 default grids untouched.
If more than 8 grids are present, it will be possible to scroll among all the grids by swiping your finger
up and down in order to reach the projection grid desired for the exam.
8.4.5 Alignment
The patient shall now place his head over the chin-rest and his forehead in contact with the foreheadrest pad (see Fig. 7). In order to have faster alignment phase, the chin-rest height shall be adjusted
so to have the patient’s eye aligned with the eye marker placed on the side of the head-rest support.
In order to perform the exam, the front lens shall be aligned to the eye to be examined, and at the
proper distance, that is 30 mm away from the cornea.
The software provides a self-alignment aid, which attempts to move the MAIA head in front of patient
eye and to align it (right-left and up-down).
Click on Goto OS (Fig. 31) to perform the test on the left eye, or on Goto OD for the right one: the
head will move towards the average position of the pupil for the selected eye.
It is then possible to align the patient manually or aided by the Auto Alignment system.
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Pushing the Auto Alignment button will start the detection of the eye currently highlighted in the
upper left corner of the live image (see Fig. 28), which is the one currently nearest to the MAIA head:
the Auto Alignment button gets highlighted to make evident the operation in process.
Fig. 31 - Self-alignment buttons
It does not make any difference to start with the right eye or with the left one, when
examining both eyes. MAIA can test one eye only, too.
Any manual intervention on the motion, either clicking on one of the Left/Right, Up/Down,
Forward/Backward buttons (Fig. 32-left) or acting on the optional 3D joystick (as illustrated in Fig.
32-right), or on the joystick of 2009 Edition (Fig. 33), will stop the automatic alignment (the Auto
Alignment button is no more highlighted) and return manual control to the operator.
To perform a manual alignment, look for a bright circular spot (the patient’s retina seen through the
pupil) as shown in Fig. 34A and Fig. 34B and use either the buttons on the touch screen (Left/Right,
Up/Down) or the optional 3D joystick to bring the spot towards the center of the image.
Fig. 32 – Buttons on the touch screen of 2013 Edition (left) and Joystick operation (right)
Towards
patient
up / down
left / right
Backward
Fig. 33 – Joystick operation of MAIA – 2009 Edition
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By moving the optical head to the RIGHT, the retinal image will shift to the LEFT and
viceversa. Similarly by moving the head UP the retinal image will shift DOWN.
A
B
C
Fig. 34 – retina alignment
The self-alignment consists of 4 steps, reported by a message superimposed to the live image, and
they are:
1) Eye Reaching: the head moves to an average position for the selected eye. The message is:
"Auto -alignment in progress : moving towards OD / OS...";
2) Eye Searching: the head performs vertical movements while changing the focus to find the pupil.
The message is: "Auto-alignment in progress: searching the eye..." . As soon as the pupil is
identified (in the live image it gets highlighted by a green circle), comes the next step;
3) Eye Approaching: the head starts to align itself to the pupil, so to bring it to the center of the
image, and, at the same time, it makes a coarse scan of the focus to increase the brightness.
Then, always keeping the pupil at the center, it begins to approach moving towards patient's eye,
performing small corrections in alignment. The message is: "Auto-alignment in progress: eye
found, approaching it ...". Once the size of the pupil takes up about 70% of the image, it passes
to the final stage;
4) Eye-aligned: the motors stop, the message becomes “Eye Aligned”, and the Auto-Alignment
button gets unlighted.
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With poorly cooperative patients or with adverse environment light condition (direct
spots to the front lens), it could be the case that the procedure does not stop, and
continues trying to align. In such a case ask to the patient to stare in front of him, correct
environment light and, if not enough, align manually.
If during one of the steps the eye is lost (i.e. it disappears from the field or cannot be recognized),
the procedure restarts from step 1.
If the eye is out of the field reachable by the head (because the patient is badly positioned on the
forehead rest, or because the chin rest is too high or too low), a message will say: "Eye is
unreachable: Please adjust chinrest and/or patient head." Act on the chin rest, or reposition the
patient to get self-alignment proceeding.
When the optical head stops moving, the operator shall manually adjust the position, that is to
move forward until the retinal image is fully framed, with no black areas in the periphery (see Fig.
34C), using the button "Forward" (or pushing forward the optional 3D joystick) and performing
needed small adjustments in alignment, in order to get the full image of the retina in the live image,
avoiding corneal reflexes and dark bars on the image itself.
Once you are all set click on the Start button. (see Fig. 39).
8.4.6 Auto-focus
MAIA will now automatically focus the retina and capture one retinal image for reference. The autofocusing process requires around 10 seconds.
During this phase also the Auto-brightness adjustment takes place: if the acquired retina image
appears overexposed, the power of the light source is decreased in order to reduce exposure.
The light source power can be adjusted in order to reach the desired image brightness
during the entire exam, acting on the “Bright +/-“ buttons, which will
increase/decrease the power in 5% steps with respect to the calibration value. Note
that the maximum value corresponds to different power levels during the
alignment/focusing phase and the stimuli projection phase.
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8.4.7 Fixation target selection
You will then be prompted to select the fixation target.
Should the image be not properly focused, the buttons for manual focusing can be used, that are
Focus + and Focus –, to adjust the focus before proceeding.
The small center circle and the twenty crosses, plus the large circle surrounding them, represent the
available fixation targets (see Fig. 35). Such circle and crosses appear on the screen with color blue
when they are off (not visible to the patient), red when they are on (projected onto patient’s retina
underlying area).
Fig. 35 - Fixation target selection
The button “Single fixation”, if clicked toggles, to “Multiple fixations” (see Fig. 36), thus allowing
to choose the fixation target selection mode:
• Single fixation mode: when this option (which is the default) is selected, by touching the
screen and dragging the finger over it, the fixation target (small circle or cross) nearest to the
touched point is turned on, while any other small target is turned off. The effect, moving the
finger onto the retina picture, is to drag the fixation target position accordingly, stepping
between the allowed positions. The large circle is turned on or off independently by the small
targets by clicking the “Toggle Big Circle” button.
• Multiple fixation mode: when this option is selected, by touching onto the screen any small
fixation target (small circle or cross) is toggled between on and off, without changing the state
(on – off) of any other small target. This way, as many targets as desired can be turned on
simultaneously. The large circle is turned on or off independently by clicking the “Toggle Big
Circle” button.
The Multi-fixation target is a hardware feature available only on the 2013
Edition. In order to help patients to see the fixation target, the owners of 2009
Edition can choose to use the standard 1° circular target, the larger 12° big circle,
or both by using the “Small/Big/Both Fixation” on-screen button.
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Fig. 36 - Fixation target: multiple selection
8.4.8 Dynamic Multifixation (DMF) Target Operation [optional, available on 2013 Edition only]
The following procedure suggests how to use the additional feature given by the additional eccentric
fixation targets (crosses).
In cases of large central scotoma, patients may have difficulties to see the standard fixation target.
In such cases the operator may select an eccentric target. Once the eccentric fixation target is visible
by the patient, the operator shall move the target towards the center of the target array trying to make
visible the central standard fixation target, as described in the following procedure.
1. As a first attempt, the operator shall ask to the patient whether he is able to see the small red
circular fixation target located in the center of the MAIA ocular.
If the patient is able to see the small central fixation target, the MAIA examination can be
performed.
2. If the patient is not able to see the standard fixation target, the operator can select an
eccentric fixation target (red cross) located outside of the scotoma area (the scotoma area is
normally created by a Geographic Atrophy in the retina and it is seen in the SLO image as a
hyper reflective area, that is a bright area).
3. Once the patient is able to see the selected eccentric target, the operator shall try to move
that eccentric target towards the center.
4. If the central fixation target is visible, the MAIA exam shall be performed. Otherwise, the
MAIA exam shall be performed with the visible cross target closest to the central circular
target.
As an aid to fixation, in order to help the patient to keep tracking the chosen target, click on Big
Fixation: this will switch ON the peripheral 12° circle.
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8.4.9 Reference image selection
When the most suitable fixation target is selected, be sure that just one fixation target is on (not
considering the large circle, which can be either off or on, and can be used as a boundary to help
the patient to find again the desired fixation target, if he loses contact with it).
Please consider that reference database data, and related indices, will be available only
using the central standard fixation target.
When ready, click on “OK” button to proceed with the exam.
If multiple fixations are on, a prompt will ask to re-check and turn off any target but one (Fig. 37)
Fig. 37 - Too many targets selected
MAIA will now capture one retinal image to be used as the exam reference, called Still Picture.
You will then be prompted to accept or reject the acquired
image: should the image be clear and focused, click on Yes.
If not, for instance because the subject moved or blinked, or
because focusing or brightness was unsatisfactory (see Fig.
40), click No. Then it is possible to retry the Autofocus
procedure with the Re-run autofocus button, or to adjust
focus and brightness manually clicking on Manual
focusing. In Manual Focusing, use the Bright +/- and the
Focus +/– buttons until the image quality is satisfactory, and
then press OK to acquire a new Still Picture to be
confirmed.
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Fig. 39 – Reference image evaluation
Fig. 40 - Images of insufficient quality to effectively run the test, because of corneal reflections (left)
and/or wrong focusing (right)
When the image is focused also the patient will see the target in focus, viceversa if
the image is NOT well focused the patient will NOT see the target in focus and this
may alter the test results.
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8.4.10 Grid centering (optional)
This option allows to test retinal areas different from the default macular area.
If the Change grid position option is selected you will be asked where to set the center of the
chosen grid by clicking on the desired point on the retinal image. Note that all stimuli outside a circle
of 30° of diameter will be rejected. Then click on Ok.
Fig. 41 – decentered grid
8.4.11 Adding custom stimuli (optional)
This option allows to test retinal areas different from the default macular area.
If the Add stimuli option is selected, you will be allowed to place custom stimuli over the image.
Depending on which button is active, you can ADD or DELETE custom stimuli.
Stimuli can be placed by clicking in the desired position on the retina image, within a 30° circle and
cannot be placed closer than 0.5° to each other.
The last stimulus added will be displayed in orange color; in the lower right frame a zoomed view of
the last stimulus placed will be displayed, with 4 arrow buttons allowing to shift it in the 4 directions
for fine-positioning (see Fig. 42).
If the DELETE button is active, tapping on a point on the retina image will delete the closest stimulus
to the point clicked.
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Fig. 42 - custom stimuli editing
8.4.12 Identifying the optic disk
You will then be asked to click on the center of the optic disk. Then press Ok. Incorrect identification
of the disc center may result in erroneous fixation losses counts, with the test being possibly falsely
considered inaccurate.
Fig. 43 – Optic disk center location
Once this operation is done, MAIA will start recording the eye movement with the
automatic eye tracking system. It is normal that the image suddenly becomes slightly
darker at this point.
The image displayed on the left half of the screen is an eye tracker-stabilized live image, while the
image on the right half is the original, untracked, live image. In about 10 seconds the actual projection
of stimuli will start.
8.4.13 PRL-initial assessment
During the first 10 seconds of the test the system records the patient’s fixation activity (approx. 250
points), the center of which is used to estimate the preferred retinal locus (PRL-initial) and center the
stimuli grid (unless option Change Grid position is enabled). During this phase the patient must
only concentrate in fixating the center of the fixation target.
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For patients showing difficulties in recognizing the fixation target, it is suggested to activate the
“Enhanced Fixation” feature (in the Settings menu, see paragraph 11.1) which will project a
blinking stimulus at the center of the fixation target in order to help its. This blinking stimulus is only
present in this phase and will disappear when the PRL-initial has been determined.
Fig. 44 – PRL-initial assessment
8.4.14 Training session
Then perimetric projection starts, with the first stimuli being used as a training session for a patient
to understand his task. Such stimuli are not considered in the test results. When/if two of such training
stimuli are responded, the true test stimuli start. If the patient does not respond to eight of such
training stimuli, the test will start anyway.
8.4.15 Initial stimuli intensity (pre-test)
In case of expert exam, MAIA initially measures the threshold at 4 points to tune the initial intensity
of the subsequent stimuli to the patient under exam. Such pre-analysis allows to reduce the test
time.
8.4.16 Monitoring the test
Test progression can be monitored by (see Fig. 45):
•
reading the “remaining stimuli” indication;
• checking the “estimated remaining time”. This information is present only in Expert/Followup exams and appears only when at least 25% of the stimuli have terminated (in order to
collect enough data for the estimation).
•
checking when the push-button is pressed, based on the corresponding signal;
• looking at the retina images: the small one on the bottom right of the window shows the live
image (just like it is being acquired by the camera); the bigger one on the left shows the
stabilized image (i.e. shifted using the information coming from the eye-tracking). The small
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•
yellow dot displayed on the stabilized image represents the current fixation point (the point of
the retina which is aligned to the center of the fixation target in this very moment).
watching the current eye-tracking status: the border of the stabilized image turns GREEN if
the eye-tracking is correctly detecting and registering the eye movements, while it turns RED
otherwise (e.g. during eye blinking or in presence of a strong misalignment due to excessive
head movement). It turns ORANGE if the exam is paused.
When the eye-tracking is unable to locate the retinal image (RED frame) the stimuli
projection is paused.
If this situation persists for more than 4 seconds, an intermittent beep sound is
emitted to alert the operator that the patient has moved and needs to be realigned to the front lens.
This alarm can be turned off de-selecting the Tracking Alarm button, and the volume
can be adjusted with the nearby buttons.
Fig. 45 – Exam interface
The meaning of the symbols appearing on the image during projection is the following:
stimulus being projected, no response
stimulus projected and seen
A stimulus intensity ranges from 0 to 36 dB, where 0 dB is the brightest intensity and 36 dB is the
dimmest one, according to the following scale:
Fig. 46 – Stimuli color scale
A stimulus marked with the symbol “<0” indicates that the maximum intensity (0 dB) has not been
seen by the patient.
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For the 4LF strategy, displayed colors have the following meaning:
seen at 25dB
seen at 15dB – not seen at 25dB
seen at 5dB – not seen at 15dB
seen at 0dB – not seen at 5dB
not seen at 0dB
For the Scotoma Finder strategy, displayed colors have the following meaning:
seen at 0dB
not seen at 0dB
The test can be paused and restarted at any time by clicking on Pause without the
data being compromised.
The test can be stopped at any time by clicking on Stop. If a test is stopped before
completion it is flagged as “incomplete” and only partial results are available.
Once the test is completed the data will be saved on the disk and the Exam review page will appear
in about 10 seconds.
8.5 Running a follow-up test
If an Expert test has been performed to certain a patient, a follow-up assessment is possible. To
run a follow-up, select the desired patient (see 0) and click on the New Follow-up button in the
corresponding expert test. Then proceed as explained at 0: MAIA will re-test the same points tested
during the baseline test.
In case of a follow-up test, the stimuli grid is NOT centered on the PRL (which may
move with respect to the baseline test) but is centered at the same point as in the
baseline test.
The follow-up mode is not available for fast tests.
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9.
REVIEWING RESULTS
In the patient list click on the desired patient (see 0), then click on the desired test from the list on
the right: the test results screen will show up as in Fig. 47.
Because no patients with cataracts were included in the reference database (see par.
18 for a more detailed description of the reference database), results must be applied
with caution for patients with cataracts or other media opacities (such as corneal scars,
vitreous hemorrhage, vitritis, etc.).
Because only patients aged between 20 and 80 years were included in the reference
database, and the cohort of patients over 70 constituted only 5% of the reference
subjects, results must be applied with caution for patients in their late 80’s, 90’s or
beyond.
9.1
Results of the fast test
Fig. 47 – Fast Test results screen
Displayed information include:
- Patient number, last name and first name, eye information (top bar);
- Exam number, type of exam, date of exam, patient age, exam duration in minutes and seconds
and Fixation Losses index (top-right panel): such index provides the percentage of control
points projected at the optic nerve which were seen by the patient (ideally 0%);
While fixation losses over 30% indicate that the test is not reliable, the above index is
based only on the percentage of fixation losses. This device does not provide other
indicators of reliability such as the percentage of false positives and false negatives.
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- Fixation points: they represent all the points of the retina used throughout the whole exam to
fixate the target: the orange ones are the points used during the first 10 seconds of the test
(a.k.a. the Registration phase), the blue ones the ones used during the rest of the exam
- BCEA analysis: the “63% Bivariate Contour Ellipse” (the smaller ellipse in the plot) represents
the ellipse describing the statistical distribution of 63% of all fixation points. Its area
(expressed in squared retina degrees) and the angle between the major axis and the
horizontal axis (measured counter-clockwise, as in figure below) are displayed in the exam
info frame. Similarly, “95% BCEA” (the larger ellipse in the plot) represents the ellipse
describing the 95% of all fixation points.
- PRLs: the magenta one (INITIAL, marked as “I”) is calculated as the center of the fixation
points recorded by the eye-tracker in the initial 10 seconds of the test; the cyan one (FINAL,
marked as “F”) is calculated as the center of the fixation points recorded in the rest of the exam;
- Stimuli and related threshold. Colors have the following meaning: green = “seen at 27 dB”,
orange = “seen at 25 dB”, red = “not seen at 25 dB”. According to the MAIA reference database,
27 dB represents the 90th percentile on normals, while 25 dB represents the 97th percentile;
- Index FIXATION STABILITY, based on the following:
o If more than 75% of the fixation points were located within a 2° diameter circle
centered in the gravitational center of all fixation points, the fixation is classified as
stable.
o If less than 75% of the fixation points were located within a 2° circle, but more than
75% of the fixation points were located within a 4° circle, the fixation is classified as
relatively unstable.
o If less than 75% were located within a 4° circle, the fixation is classified as unstable.
- Index AVERAGE SUPRA-THRESHOLD RESPONSE: The responses at individual points
(seen at min intensity, seen at max intensity, not seen) are summed into one index indicated
as AVERAGE SUPRA-THRESHOLD RESPONSE.
Based on the reference database from approximately 500 normal eyes which is included in the
MAIA (see par. 18), colors indicate whether the value of this index is:
• above the 10th percentile of normals (GREEN) or
• below the 10th percentile but above the 5th percentile (YELLOW) or
• below the 5th percentile (RED).
A RED outcome indicates in other words that results lower than or equal to the present were
found in only 5% of the reference normals. A YELLOW outcome indicates that results lower
than or equal to the present were found in only 10% of the reference normals. Conversely, a
GREEN outcome indicates that results equal to or higher than the present were found in 90%
of the reference normals.
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The MAIA reference database reflects threshold values measured within 5° from the
fovea. Results of the fast test on a non-centrally fixating patient are not comparable to
the reference database values, as the measured area is not central.
Available functions include:
- Image zoom and pan, zoom to stimuli grid and restore to full image
(Reset Zoom)
- Allows to set the position the Estimated Fovea Location (EFL) marker
over the retinal image
- Enabling / disabling display of the fixation target
- Enabling / disabling display of the PRLs and the EFL
- Display stimuli / hide stimuli / display stimuli with their IDs (3 options)
- Display all fixation points recorded during the test / display only
fixation points recorded during stimuli projection / disable display of
fixation points (3 options)
- Print (on paper, USB key or shared folder): generates a PDF file
containing the report of the exam (see 10.PRINTING)
- Export (to USB key or shared folder): generates a PNG file of the
entire retina, with the overlapped layers currently selected for
visualization
The EFL (Estimated Fovea Location) marker is a landmark that can be placed over the
retinal image, at the discretion of the operator, in order to evaluate the position of the
fovea with respect to the PRLs (Initial and final). It has no effect in the calculation of
the Fixation Indexes and the BCEAs.
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9.2
Results of the expert test
Fig. 48 – Expert Test results screen: 4-2 strategy
Fig. 49 – Expert Test results screen: 4-Levels-Fixed strategy
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Fig. 50 – Expert Test results screen: Scotoma Finder strategy
Fig. 51 – Expert Test results screen: Fixation Only strategy
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Displayed information include:
- Patient number, last name and first name, eye information (top bar);
- Exam number, type of exam, date of exam, patient age, exam duration in minutes and seconds
and Fixation Losses index (top-right panel): such index provides the percentage of control
points projected at the optic nerve which were seen by the patient (ideally 0%);
While fixation losses over 30% indicate that the test is not reliable, the above index is
based only on the percentage of fixation losses. This device does not provide other
indicators of reliability such as the percentage of false positives and false negatives.
- Fixation points, BCEA analysis and PRLs (just like the Fast exam); the Fixation Only strategy
provides the Fixation Outcome chart, which plots the distance of each fixation point from the
PRL-f over time;
- Stimuli and related threshold (or supra-threshold) in dB, where color scales are the ones shown
during the test and illustrated in paragraph 8.4.16; it is also possible to view the interpolated
sensitivity map (see Fig. 52, Fig. 53, Fig. 54), a map representing the sensitivity on each point
of the retina using the information coming from the nearby stimuli;
- Index AVERAGE THRESHOLD (only for 4-2 strategy): the displayed value is the average
threshold across all measured points and is expressed in dB. Based on the reference database
of approximately 500 normal eyes which is included in the MAIA (see par. 19), colors indicate
whether the average threshold is:
• above the 10th percentile of normals (GREEN) or
• below the 10th percentile but above the 5th percentile (YELLOW) or
• below the 5th percentile (RED).
A RED outcome indicates in other words that results lower than or equal to the present were
found in only 5% of the reference normals. A YELLOW outcome indicates that results lower
than or equal to the present were found in only 10% of the reference normals. Conversely, a
GREEN outcome indicates that results equal to or higher than the present were found in 90%
of the reference normals;
- Index FIXATION STABILITY, based on the following:
o If more than 75% of the fixation points were located within a 2° diameter circle
centered in the gravitational center of all fixation points the fixation is classified as
stable.
o If less than 75% of the fixation points were located within a 2° circle, but more than
75% of the fixation points were located within a 4° circle, the fixation is classified as
relatively unstable.
o If less than 75% were located within a 4° circle, the fixation is classified as unstable.
The displayed values, indicated as P1 and P2, represent the percentage of fixation points
located respectively within the 2° and 4° circles.
- Index PERCENT REDUCED THRESHOLDS (only for 4-2 strategy): although the AVERAGE
THRESHOLD provides a global index of macular function, it is not sensitive to localized
defects, which may be masked by the averaging process. In fact the PERCENT REDUCED
THRESHOLDS has been derived as an additional functional index that is more sensitive to
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localized functional alterations. The displayed value represents the percentage of measured
thresholds below 25 dB.
Low values of this index are associated with good sensitivity.
Colors indicate whether the value of the index is:
o below the 90th percentile of normals (GREEN) or
o above the 90th percentile but below the 95th percentile (YELLOW) or
o above the 95th percentile (RED).
A RED outcome indicates in other words that results higher than or equal to the present were
found in only 5% of the reference normals. A YELLOW outcome indicates that results higher
than or equal to the present were found in only 10% of the reference normals. Conversely, a
GREEN outcome indicates that results equal to or lower than the present were found in 90%
of the reference normals.
The MAIA reference database reflects threshold values measured within 5° from the
fovea. Results of the 4-2 Expert test on a non-centrally fixating patient are not comparable
to the reference database values, as the measured area is not central.
As a consequence, the Percent Reduced Thresholds index is available only for exams
taken using the 4-2 strategy and the standard 10° grid, without moving the grid position
(i.e., leaving it centered on the PRL-i).
Available functions include:
-
Image zoom and pan, zoom to stimuli grid and restore to full
image (Reset Zoom)
-
Allows to set the position the Estimated Fovea Location (EFL)
marker over the retinal image
-
Enabling / disabling display of the fixation target
-
Enabling / disabling display of the PRLs and the EFL
-
Display stimuli and the corresponding threshold values /
display stimuli and interpolated sensitivity map (see Fig. 52) /
disable display of stimuli /
display stimuli IDs [preceded by “#”] (4 options)
-
Display all fixation points recorded during the test / display
only fixation points recorded during stimuli projection / disable
display of fixation points (3 options)
-
Print (on paper, USB key or shared folder): generates a PDF
file containing the report of the exam (see 10.PRINTING)
Export (to USB key or shared folder): generates a PNG file of
the entire retina, with the overlapped layers currently selected
for visualization
-
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Fig. 52 – Interpolated sensitivity map (4-2 strategy)
Fig. 53 – Interpolated sensitivity map (4-Levels-Fixed strategy)
Fig. 54 – Interpolated sensitivity map (Scotoma Finder strategy)
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9.3 Follow-up results and differential map
In presence of follow-up exams, it is possible to display differential values between two consecutive
tests and the time changes of the numerical indices provided by MAIA (average threshold, fixation
stability and percent reduced threshold).
Follow-up tests are displayed underneath the corresponding expert test and are slightly
shifted on the right.
Fig. 55 - patient record with 3 follow-up exams
To access the differential map click on the TIME ANALYSIS button.
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Fig. 56 - time analysis screen: 4-2 strategy
On the right, for the 4-2 strategy, such screen shows a time plot of indices AVERAGE THRESHOLD,
FIXATION STABILITY and PERCENT REDUCED THRESHOLD. The horizontal axis represents
time and the vertical one the values of the indices. The green, yellow, red colors of the areas have
the same meaning, for each index, as described in par. 9.2. The blue bar highlights the two
consecutive exams that are compared on the left of the screen.
The image displayed on the left is that of the first test.
Values represent threshold differences in dB between the second and first test.
Click on the Image: 1 or 2 buttons to choose whether to display the differential values
respectively over the image of the first or second test. This command can be used to
verify proper registration between the images of the two tests being compared.
If stimuli appear at remarkably different retinal locations in the two images, a poor image
registration has occurred. In such case results of the two exams are correct but
differential threshold values should be regarded with care, as different retinal locations
were measured in the two exams.
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Fig. 57 - time analysis screen: 4-Levels-Fixed strategy
In case of 4-Levels-Fixed strategy the right section of the screen shows two graphs:
• AVERAGE STIMULI depicts by an histogram, for each exam, the percentage distribution of the
4 different responses (black means 0 dB not seen);
• FIXATION STABILITY is a time plot of the related index, where the horizontal axis represents
time and the vertical one the values of the index. The green, yellow, red colors of the areas have
the same meaning described in par. 9.2. The blue bar highlights the two consecutive exams that
are compared on the left of the screen.
The image displayed on the left is that of the first test.
Values represent differences, in levels, between the second and first test.
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Fig. 58 - time analysis screen: Scotoma Finder strategy
In case of Scotoma Finder strategy the right section of the screen shows again two graphs:
• AVERAGE STIMULI depicts by an histogram, for each exam, the percentage distribution of the
2 different responses, i.e. “seen at 0 dB” (orange) and “not seen at 0 dB” (black);
• FIXATION STABILITY is a time plot of the related index, where the horizontal axis represents
time and the vertical one the values of the index. The green, yellow, red colors of the areas have
the same meaning described in par. 9.2. The blue bar highlights the two consecutive exams that
are compared on the left of the screen.
The image displayed on the left is that of the first test.
Values represent differences, in levels, between the second and first test.
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Fig. 59 - time analysis screen: Fixation Only strategy
In case of Fixation Only strategy the right section of the screen shows again three graphs:
•
•
FIXATION STABILITY is a time plot of the related index, where the horizontal axis represents
time and the vertical one the values of the index. The normal, suspect and abnormal areas are
colored in green, yellow and red. The blue bar highlights the two consecutive exams that are
compared on the left of the screen.
BCEA 63% and 95% AREA are a time plot of the areas of the BCEA describing the distribution
of the fixation points of each exam. The blue bar highlights the two consecutive exams that are
compared on the left of the screen.
Whatever the strategy, click on “previous pair” or “next pair” to select two different tests for
comparison.
Click on stimuli to enable/disable display of the differences.
Click on fixation to enable/disable display of the fixation points and PRLs of the two tests: points of
the first test are in green and the PRL in yellow (points in blue and PRL in magenta for the second
test).
The following information is also presented on the top:
• avg diff (4-2 strategy only): indicates the average difference in dB between the two tests;
• P1 e P2: shows the change in fixation stability;
• prl dist: indicates the distance in degrees between the two PRLs
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9.4
Handling patient’s data
In the patient’s record screen it is possible to delete an exam, edit the patient data or delete
permanently the entire patient record and the related exams.
To delete an exam press the trash icon displayed on the right of the exam line. A confirmation box
will appear: press “delete” to confirm or “cancel” to abort and go back to the patient page.
To delete a patient and all related exams, press the trash icon on the right of the patient’s name. A
confirmation box will appear: press “delete” to confirm and “cancel” to go back to the patient’s page.
By pressing the pencil icon on the right of the patient’s name, it is possible to change a patient’s data
or add notes.
Fig. 60 – editing patient data
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If a USB drive is plugged in, a USB icon appears on the top bar (indicated by the circle in Fig. 61):
pressing it will allow to export all the data of the current patient in the USB drive as a partial backup:
the backup can then be imported on another unit (with the “Append” mode, see Par. 6511.7) in order
to perform follow-up exams of the patient: this function is useful for clinics with more than one MAIA
or for multicentric clinical studies.
Fig. 61 – exporting patient data
When re-importing the patient’s data, if the patient is already present in the unit
database it shall be deleted or renamed, otherwise the exams already present will be
duplicated.
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10.
PRINTING
To print a test results click on Print In the results screen, then select Printer as destination (see Fig.
63). If no printer is connected the Printer option will not be enabled. Check on paragraph 11.8 how
to configure your printer. To print to pdf file click on Print then select USB key as destination. If the
shared folder is enabled and correctly configured in settings, also the option Ext. shared folder will
be available. The following picture shows a printout example:
1
3
2
5
4
6
7
8
9
1
0
1
1
1
2
Fig. 62 – Print layout
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The printout includes the following information:
1. Printout header, reporting the following information:
▪ Hospital/Clinic name (if specified in the settings)
▪ Patient last name / first name
▪ Eye (OD/OS)
▪ Patient date of birth / age
▪ Type of exam (expert, fast, follow-up) and number
▪ Date and time of exam
▪ Duration of exam
▪ Fixation Losses index
▪ Patient code and Social Security Number (enabled in settings and specified for the patient)
2. Full retinal image
3. Zoom on sensitivity map (dB) with fixation points
4. Full image with interpolated threshold color map
5. Average supra-threshold response (only for Fast test) / Percent reduced thresholds (only for
Expert test with 4-2 strategy)
6. Average threshold (dB) (only for Expert test with 4-2 strategy)
7. Histogram of threshold frequencies vs. MAIA reference database
8. Fixation plot with Bivariate Contour Ellipse Area (BCEA) analysis.
9. Fixation stability indexes
10. Fixation graph: shows a time plot of the distance (in degrees) between the fixation point at any
given time and the average fixation position
11. Notes
Fig. 63 – Printout destination choice (left: printer connected; right: printer not connected)
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11.
SETTINGS
To access the Settings page, click on the
The following tabs are available:
• Preferences
• Time
• Network
• Security
• System
• Share
• Backup
• About
icon in the top right corner of the patient list screen.
11.1 Settings - Preferences
This page allows to activate:
• an additional patient code, to be typed when inserting a new patient (option Custom Patient
Code);
• a patient’s Social Security Number;
• the name of the Hospital / Clinic / Organization, which will appear in the printouts.
• Enable/disable the enhanced Fixation options, i.e. the projection of a blinking 0dB stimulus
at the center of the fixation target during the determination of the PRL-high, that will increase
the patient concentration on the fixation target.
• The exam default settings for Vision Condition (applies to S-MAIA only), Strategy and Grid:
the values selected will be selected by default when entering the Expert exam interface;
selecting “Last used” will set the option selected when exiting the Exam interface the last
time.
Click on Save changes to store the preferences.
Fig. 64 – Settings / preferences
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11.2 Settings - Time
This page is used to set the current date and time. Click on Set date / time to save the changes.
Fig. 65 – Settings / Time
11.3 Settings - Network
This page allows to enable remote data access from any computer connected through the LAN to
the MAIA. The system will automatically perform a network scan to see if any LAN or Internet
connection is available. MAIA needs to be connected to the LAN via Ethernet cable to enable this
feature.
Fig. 66 – Settings / Network
Check network configuration
Once the network scan is completed, the result will be displayed on the screen next to the Current
network status label.
The result can be any of the following:
• Internet connection fully available on address XXX.XXX.XXX.XXX: MAIA is fully connected
to the Internet (this option can be used for technical support purposes).
• LAN working on IP XXX.XXX.XXX.XXX: a valid network is set and the local network is ready.
• No working connection: MAIA is not connected to any network.
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In the first and second case it is possible to review the MAIA exams via any PC connected to the
local network, by typing the MAIA IP address on the remote PC’s Internet browser. The network
status and MAIA IP address are also shown at the bottom of the startup screen: the network label
says either “Internet” or “local” or “off” according to the above conditions.
Network configuration
In most of the modern LAN it is sufficient to connect the network cable to MAIA (see Fig. 2) and keep
the default configuration (Automatic DHCP). If no valid IP address is retrieved it will be necessary
to configure the network manually.
Fig. 67 – Manual configuration of the network
To do that, proceed as follows:
ask your network administrator to provide appropriate IPV4 address (mandatory), netmask
(mandatory), gateway (optional) and DNS (optional) for your network;
select the Manual network configuration option;
type the above data in the corresponding fields and click on Set network.
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11.4 Settings - Security
MAIA allows to setup a password protection in order to prevent unauthorized access to the patients
data stored in the unit. It is possible to setup two different passwords: one for local access and one
for the access through the remote viewer.
The Security menu (see Fig. 68) allows to configure the password protection parameters.
Fig. 68 – Security configuration
The top part of the page allows to enable/disable the password used to access the unit via the
Remote Viewer. In order to set a new password, press the “Enable” button and input the desired
password in the text field below, then press “Set pass” button to make it active.
The bottom part allows to setup the password for the local access (in the unit monitor). The password
set will be prompted at the system startup. It is also possible to set the Lockscreen delay: when the
selected amount of time elapses without any user interaction on the unit monitor, the system will lock
up prompting to input the password (see Fig. 69).
If a password has been set, it is possible to activate the lock screen immediately by pressing the
Lock icon (
) on the right of the top bar.
Fig. 69 – Lockscreen prompting for the password
When a password is set for the Remote Viewer, any previously logged-on user will be
presented the Lockscreen prompting to input the remote access password.
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11.5 Settings - System
This menu gives access to the following diagnostic tools:
- Reset head, that forces the auto-reset of the motors (the same operation that takes place
also at the system startup)
- Calibrate Touch-screen, that allows to recalibrate the touch-screen display: the calibration
consists in pressing with the finger at the center of the symbol below until it moves to the
following corner of the screen.
-
-
-
System checkup, that checks the hard-disk integrity
Remote assistance, that enables the remote assistance: this will allow Service technicians
to connect to the device using a remote display protocol (VNC) or a console protocol (SSH).
Once clicked and accepted the disclaimer, the authorization code needed to connect will
appear: this must be communicated to the technicians that need to connect to the unit. A
label below the button will display the code and the connection status (Closed, Waiting for
connection or Active). To close the remote assistance, click again on this button: all the
currently connected clients (both VNC and SSH) will be disconnected; it will be closed
automatically at the next system reboot, anyway.
Shipment position, that moves the optical head in a position suitable for shipment in
order for MAIA to be placed in its box, then switches off the unit.
Reset database, that allows (after proper confirmation) to delete all patients data and exams
stored in the system.
Service Access, that allows to enter the password-protected Service Panel or Calibration
Interface.
Raw Data Export, that launches the Raw Data Export tool which allows to export all exams
data in .txt files for advanced statistical analysis. For further details, check the par. APPENDIX
B: RAW Data Export Tool.
Update Software, that launches the Software Updater which allows to install software
updates and packages provided by CenterVue.
Upload log files and Save log files on USB, that allow to extract the system log files of the
unit (mostly in encrypted format) and either upload them directly to CenterVue Service
servers, or to store them on a USB drive in order to be sent via email to Service technicians.
Beware: the reset database operation cannot be cancelled or restored unless
you have backed up your data!
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Fig. 70 – Settings / System
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11.6 Settings - Share
This page allows to setup the export of images and printouts to an external windows network shared
folder:
- On/off buttons enable/disable the shared folder.
- JPEG/PNG/PDF allow to select the export format for images and printouts
- Auto/manual determine if the export will be done automatically at the end of each exam, or
manually (using the export/print button in the exam local viewer)
- It is possible to select also the template of the filename that will be generated
- Configure allows to reconfigure the shared folder
In the lower left corner, you can see the network path of the currently configured shared folder
Fig. 71 – Settings / Shared folder configuration
The Shared Folder connection uses Samba (SMB) protocol. From v. 2.6.0, MAIA
supports SMB protocol up to version 3 (SMBv3); earlier sw versions support SMBv1
only.
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When shared folder is enabled the system checks automatically if there is a configured shared folder
and if there is one it checks the connection. The status of the current configuration is always in the
lower part of the screen:
• the block flashes in grey when it is checking the connection
• the block becomes light green if the current connection is working
• the block becomes red if the current connection fails to work
If shared folder is enabled the system examines if the current configuration is valid.
• if the system has no shared configuration at all, it forces to set a configuration in order to be
set to "ON"
• if the system has an invalid configuration, a window displays an error in shared folder
connectivity, and it is possible to press "cancel" to keep the current configuration even if it
not working in that moment
To configure the shared folder to connect press the button “configure”. A popup window appears
asking for:
• hostname or IP address of the pc where the shared folder is configured
• the name of the network shared folder. It is possible to configure a subfolder of a network
shared folder, by entering the full path with “/” (forward slashes) or “\” (backslashes) as
subfolder separators
• Username, password and Windows Domain. These are optional parameters that depend on
the Shared Folder configuration. Username and Password are usually needed to connect to
the Shared Folder. They can be set to blank to connect to the shared folder anonymously. It
is possible to insert also the windows domain, as an optional parameter. The domain is
seldom needed for some Windows configurations.
The system tries to connect with the information provided.
If the connection is successful, a message informs that it is all OK and the system is ready to work
with the configured shared folder:
If guest access fails, a message informs the user that the configuration doesn't work and leaving the
option to the user to leave the configuration as it is or to change the connection parameters.
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The exact message shown also depends on which Windows Server is being used. Most common
messages, such as the three examples shown below, are accompanied with a suggestion for
resolution.
Less common messages will be displayed as they are received from the Windows Server, and can
be very useful to detect a problem if present.
The configuration parameters are saved on the MAIA and will remain even after shutdown.
It is possible to configure separately IMAGES, PRINTOUTS and TIME ANALYSIS to be exported
manually or automatically. In the case of Time analysis only manual export is possible.
If automatic export is selected, images and/or printouts are exported automatically at the end of each
exam.
If manual export is selected:
• from the exam local viewer, it is possible to export the image by selecting “Export” and then
“Ext. Shared folder” button. The image will be exported with the layers that are shown in that
moment
• from the exam local viewer, it is possible to export the printout by selecting “Print” and then
“Ext. shared folder” button
• from the Time Analysis viewer click on the “SHARED FOLDER” button to export what is
shown on the screen.
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Only when shared folder is enabled, and it is correctly configured, that is when the lower part of the
screen is in light green and the current connection is working, below the block a BATCH EXPORT
button appears.
By clicking such button, a batch process is started, which exports as a whole ALL the exams saved
in the unit. A dialog box with the two buttons IMAGES and PRINTOUTS allows to choose the kind
of files to be exported.
The export will then start. A dialog box will show the process progress, which, depending on the total
number of exams, could be very long. A STOP button allows to abort the process at any time.
Fig. 72 – Batch export - choice
Fig. 73 – Batch export – progress window
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11.7 Settings - Backup
This page allows to perform a full data backup on an external USB media (USB key or hard drive)
or on a remote shared folder (the same used to export the Images and the Printouts, see par. 11.6),
and is divided in two frames (see Fig. 74):
-
The top frame allows to perform the backup/restore from the USB media: plug it in one of the
available USB ports and press Start Backup.
The bottom frame allows to perform the backup/restore from the previously configured shared
folder. The frame shows the connection status of the shared folder and its network path, if
connected. If the shared folder is not configured correctly, the message at Fig. 75 is displayed
and the bottom frame is disabled. The Start Backup button in this frame allows to start a
backup and store it in the remote shared folder.
This procedure will make a complete copy of all stored data.
MAIA indicates the capacity on the storage system required to perform the data
backup: if the space available is not sufficient, it will not be possible to effectively
perform the backup.
It is fundamental to frequently backup the data in order to prevent any possible data
loss due to a failure of the internal hard drive.
From this page it is also possible to restore an existing backup archive into MAIA by inserting the
USB key containing the backup data and using the related button (see Fig. 74).
Fig. 74 – Settings / Backup
Fig. 75 – Settings / Backup: shared folder not connected
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According to operator’s choice (Fig. 76) this operation can either REPLACE (Erase current) the
data currently stored in the system, or MERGE (Append current) data from backup with the existing
data.
Fig. 76 - Restore method selection
Restore operations cannot be undone. The use of “erase current” button will delete
all data contained in the MAIA.
Restoring a backup archive in APPEND mode will probably alter the original patient
and exam IDs, both if the archive was generated by the same unit, and if it was
generated by another device.
When restoring a backup archive in APPEND mode, in case of duplicate patients found
(with the same name, surname and date of birth), corresponding exams will be merged
inside the same patient folder. Since sw 2.6.0, already-existing exams are not restored
so no exam duplication occurs. At the end of the process, the outcome of the Restore
is displayed, reporting how many patients and exams have been imported, merged or
skipped because they were already present (see Fig. 77).
Fig. 77 - Restore procedure outcome
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11.8 Settings - About
This page provides the following information:
• The unit serial number;
• The installed software version;
• Optional modules installed;
• The list of supported printers (built-in driver).
By clicking the button POSTSCRIPT, the built-in postscript driver is enabled instead: in this case any
available printer providing genuine (non-emulated) Postscript3 protocol support can be used.
Some Postscript compatible printer require to be pre-configured, in order to be used
as Postscript printer and not with proprietary driver: please refer to the printer’s
accompanying documentation.
By clicking the button BUILTIN, only the printer model listed on the page can be used.
Currently selected option is the one highlighted in dark cyan.
By clicking the button “more” the information expands including more detailed information usually
needed for service intervention, such as:
• The installed Operating System version
• The firmware, software and OS versions
• The Production ID of the device, useful for components traceability
• The Ethernet MAC address, useful for firewalled networks
•
The space left on disk. When this value is below 10 GB it is advisable either to remove some
patients/exams in order to free some space on disk, or to perform a Reset database, or to
contact service assistance.
•
The number of records (patients and exams) stored in the unit DB
Fig. 78 – Settings / About
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12.
REMOTE VIEWER
It is possible to access MAIA from a remote computer to review exams, images and data stored in
the device. This procedure allows one for example to analyze the images on a PC equipped with a
high-resolution monitor or to make the data available on a PC located in a room far from the
instrument. In order to accomplish this, it is necessary to:
• connect MAIA to the local network in order to get the MAIA IP address and follow the procedure
described at par. 11.3;
• type the MAIA IP address in the URL box of the browser.
Supported browsers: Internet Explorer 7 or more recent, Firefox 3 or more recent,
Apple Safari.
Once the connection is established, the startup screen will show up on the remote PC.
Fig. 79 – startup screen on remote PC
Available functionalities include:
- Patient list;
- Creation of a new patient;
- Access to the settings page;
- Access to the patient record and related exam list and access to individual exams.
Other functionalities are not available through remote connection, in particular:
- Execution of a new exam;
- Network configuration.
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Fig. 80 – Results screen via remote access
The remote viewer behaves exactly like the local viewer of the instrument.
Available functions include:
- image zoom;
- overlay of the fixation target, PRL, stimuli and fixation points;
- Zoom to grid: zooms to the area covered by the perimetric grid;
- Reset zoom: shows the entire image;
- Print: generates a pdf printout of the exam, ready to be printed with the pc;
- Save as: downloads the retina image with all the layers (target, PRLs, fixations, stimuli)
currently selected.
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13. SYSTEM SHUTDOWN
To shutdown the system go back to the patient list and click on POWER OFF. Wait for the progress
bar to completely roll back and then turn off the main switch.
Turning the system off by the main switch without completing shutdown procedure
could result in data loss and in damages to the internal storage system.
14.
CLEANING
This paragraph explains how to clean the system.
The chin rest and the front rest shall be disinfected, between one patient and the next. The
disinfecting solution should be applied using a wipe, taking care of not sprinkling parts not belonging
to the patient rest. Painted parts of the chin rest, such as the twist grip, should not be cleaned by
means of aggressive solutions.
The objective should be cleaned by using a small rubber blower, to blow away dust. Only if really
needed, for instance due to the presence of a fingerprint, the objective can be cleaned by means of
photographic cleaning paper, dampen by ethyl alcohol.
The touch screen panel should be cleaned only with a cloth damped in water.
When cleaning the rest of device, the device must be off, and the power cord shall be disconnected
from mains. If needed, the external covers of the unit can be cleaned by means of a slightly damp
cloth.
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15.
BASIC TROUBLESHOOTING
This paragraph provides very simple instructions to perform basic troubleshooting.
Symptom
Possible Cause(s)
Solution
The main switch does not light up
The power cable is not properly
Connect the power cable
when turned ON
connected
Start the test with the system head
It is impossible or very hard to align to The system head is not positioned
fully retracted (far from subject’s eye)
the subject’s pupil
properly when starting the test
to enlarge the observed field
The LCD is blank after turning ON the
Failure of the LCD or failure of the
main switch, even if the main switch
Contact service representative
internal PC
lights up
The retinal image is blurred after
Adjust focus manually with the
Auto-focus software failure
performing the auto-focus
Focus+ and Focus- commands
When turned ON, the system makes a
Failure of a motor, connector or
strange noise and does not move to
Contact service representative
movement limiting sensor
the usual starting position
At the system startup you see the
Communication problem with the main
message “Unable to connect to
Contact service representative
control board
control board”
At the system startup you see the
The BIOS battery responsible of
message “System date could be
BIOS battery fault
updating the system date has
wrong”
discharged. Replace it.
Entering the exam interface you
Try to exit and re-enter the exam
Problem with the reset of the motors
receive the message “Projection
interface. If the problem persists,
responsible of deflecting the stimulus
System initialization failed”
contact service representative
Stimulus is outside the fixation target
Projection System is unstable or out
during the “Projection System
Contact service representative
of calibration
checkup” (see Par.8.1)
Check joystick operation at par. 0
Wrong use of the joystick
The head reached the position limits Correct the position of the subject’s
The head of the system does not
in that direction
head
move in one direction
Failure of a motor or of a proximity
Contact service representative
sensor or of a cable
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16.
ELECTROMAGNETIC COMPATIBILITY
This device is classified in class B according to IEC60601-1-2.
This device has been tested and found to comply with the limits for medical devices contained in
IEC60601-1-2 and Medical Devices Directive 93/42/EEC. These limits are intended to provide
reasonable protection against harmful interference in a typical medical installation. This instrument
generates, uses and can radiate radio frequency energies and, if not installed and used in
accordance with these instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation. If the
system does cause harmful interference to other devices, which can be determined by turning the
system off and on, try to eliminate the interference by adopting one or more of the following
measures:
• reorient and/or relocate the receiving device;
• increase the distance between the devices;
• connect the system to an outlet on a different circuit than that to which the other devices is
connected;
• consult the manufacturer or field service technician for help.
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TECHNICAL SPECIFICATIONS
17.
Class and type of applied part
1, B (according to CEI EN 60601-1).
IP classification
IPX0 (according to the degree of protection provided by the enclosure with respect to harmful
penetration of particulate matter or water).
Fundus imaging
• Line scanning laser ophthalmoscope
• Field of view: 36° x 36°
• Digital camera resolution: 1024 x 1024 pixel
• Optical resolution on the retina: 25 microns
• Optical source: infrared superluminescent diode at 850 nm
•
•
Imaging speed: 25 fps
Working distance: 30 mm
Fundus perimetry
• Standard macular test 10°
• Projection field: 30° x 30°
• Tracking speed: 25 Hz
• Stimuli size: Goldmann III
• Background luminance: 4 asb
• Stimuli dynamic range: 36 dB
• Maximum luminance: 1000 asb
Other features
• Minimum pupil diameter: 2.5 mm
• Focus adjustment range: from -15D to +10D (auto-focus)
• Automatic OD/OS recognition
• Pushbutton presence detection [2013 Edition only]
• Multiple fixation targets [2013 Edition only]
Optional accessories
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•
•
•
Printer
Electrical table
3D joystick [2013 Edition only]
Dimensions
• 2013 Edition:
• Unit size (WxHxD): 348 × 580 × 600 mm (13.7 × 22.8 × 23.6 in)
• Unit weight: 23 kg (50.7 lbs)
• 2009 Edition:
• Unit size (WxHxD): 522~540 × 556~560 × 482 mm (20.5~21.2 × 21.9~22.0 × 18.9 in)
• Unit weight: 28.5 kg (62.8 lbs)
Power requirement
• Voltage: 100-240 VAC, 50-60 Hz, fused 3.15 A (T type)
• Power consumption: 110 VA (2013 Edition), 300 VA (2009 Edition)
Laser classification
• Class I laser product conforming with 60825-1 IEC:20007
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18.
REFERENCE DATABASE
MAIA is provided with a reference database for threshold sensitivity, upon which several of the MAIA
test outcomes are based.
The reference database was developed as follows, using MAIA model 1:
• threshold sensitivity data have been obtained from 270 normal subjects, at 4 different clinical
sites.
• Subjects were recruited among the clinics personnel and among the relatives of the clinics
regular patients.
• Subjects were offered to participate in a study by asking them the following: "You are being
asked to volunteer for a medical research experiment. This study is being done to see how
well a medical device evaluates macular function. You may receive the benefit of information
about your health and a chance to be in a research study that may help others."
The inclusion criteria were:
• subjects of either sex and of any race or ethnicity;
• subjects between 20 and 80 years of age, inclusive;
• subjects with visual acuity of 20/20;
• absence of drusen or retinal pigment epithelium changes as evidenced by bio-microscopic
examination of the macula and photographic documentation.
The exclusion criteria were:
• subjects with significant media opacities (e.g., cataracts), any maculopathy, or diabetic
retinopathy;
• subjects with histories of traumatic retinal injuries;
• subjects with glaucoma or amblyopia;
• subjects who have undergone macular retinal laser treatment;
• subjects using Plaquenil or any drug that could affect visual acuity assessments (concomitant
use of vitamins was allowed).
• In order to establish exclusion/inclusion criteria, all subjects also underwent best corrected
visual acuity assessment, non mydriatic fundus photography, bio-microscopic evaluation of
the fundus.
• The age distribution of the population was as follows:
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The default stimuli grid was used for the measurements, corresponding to the central 10° macular
area. Furthermore, the following MAIA device settings were used:
• Number of stimuli: 61;
• Size of stimulus: Goldmann III (26 arcmin);
• Duration of stimulus: 200 ms;
• Background luminance: 4 asb;
• Maximum luminance: 1000 asb;
• Threshold algorithm: standard 4-2 staircase;
• Measurement scale: 0 to 36 dB;
• Fixation target: central circle of 1° diameter.
• Perimetric field of view: 20°x20°
Fig. 81 – Grid used to generate the reference database
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19.
PRECISION
A precision study was conducted which measured both individual location thresholds (n = 37 per
eye) and average threshold over all locations. The default 10° stimuli grid was used for the
measurements. Three devices were used, each operated by a different operator. The study included
24 subjects, each tested on one eye only: 12 without pathology and 12 with pathology. Each
subject/eye was tested 3 times within a session (3 repeated measures for each subject). Subjects
were nested within each configuration, that is, each subject appears in one, unique device-operator
configuration only. The design was repeated twice: once for healthy eyes and once for eyes with
pathologies. The study was completed using MAIA model 1 (hw ver.4.08).
Subject selection criteria
Twelve subjects with normal eyes and twelve subjects with retinal pathologies were enrolled at two
different clinical sites based on the following criteria:
• 4 normal subjects and 4 subjects with retinal pathologies enrolled at site 1 and measured
with device 1 by operator 1;
• 4 normal subjects (different from above) and 4 subjects with retinal pathologies (different
from above)enrolled at site 1 and measured with device 2 by operator 2;
• 4 normal subjects and 4 subjects with retinal pathologies enrolled at site 2 and measured
with device 3 by operator 3;
Within each pathology category, subjects with varying parameters including age and visual acuity
were enrolled. For the pathology group, subjects were enrolled with:
• early age-related macular degeneration
• intermediate age-related macular degeneration
• mild non-proliferative diabetic retinopathy (ETDRS 20)
• moderate non-proliferative diabetic retinopathy (ETDRS 43)
• moderately severe non-proliferative diabetic retinopathy (ETDRS 47)
• severe non-proliferative diabetic retinopathy (ETDRS 53)
• proliferative diabetic retinopathy (ETDRS 61)
Diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist,
including dilated funduscopic examination and pertinent history. Subjects met defined inclusion
criteria, but none of the exclusion criteria.
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Precision results
Normal
Pathology
12
12
Overall Mean
29.7 dB
23.5 dB
Overall Standard deviation
1.14 dB
4.23 dB
Repeatability SD*
0.42 dB
0.75 dB
Reproducibility SD**
0.96 dB
0.75 dB
# subjects
* estimate of the standard deviation among measurements taken on the same subject using the same operator and
device in the same testing session with repositioning.
** estimate of the standard deviation among measurements taken on the same subject using different operators and
devices, including repeatability.
Individual Grid Point Results
MAIA contains ePHI (electronic Personal Health Information) in its internal storage that must be
erased before the device can be decommissioned. Contact your CenterVue Authorized Service
Center to request information about the correct data wiping procedure.
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20.
DECOMMISSIONING AND DISPOSAL
MAIA contains ePHI (electronic Personal Health Information) in its internal storage that must be
erased before the device can be decommissioned. Contact your CenterVue Authorized Service
Center to request information about the correct data wiping procedure.
MAIA is made of different materials, such as plastics, aluminum, electronic parts. In case of
instrument disposal, please separate the various materials and follow the laws and regulations
regarding disposal or recycling for each material effective in your own country.
Separate collection for electrical and electronic equipment
The European Directive 2012/19/UE establishes the separate collection for Waste of Electrical and
Electronic Equipment (WEEE). The users of Electric and Electronic Equipment (EEE) have not to
dispose of WEEE as unsorted municipal waste, they have to collect such WEEE separately. The
available return and collection system is defined by the local public administration, or in alternative
an authorized company can recycle the WEEE. Please refer to public administration about the
separate collection, if this information is not available, contact the manufacturer of the equipment.
Users have a fundamental role in contributing to reuse, recycling and recovery of WEEE. The
potentially dangerous substances contained in the WEEE can pollute the environment and produce
harmful effects to the human health. Below, there are a few indications of specific dangers of some
substances, which may leach in the environment and in the water system.
Lead: damages the nervous system of humans, it affects the endocrine system, the cardiovascular
system and kidneys. It accumulates and is very toxic for animals, plants and micro-organisms.
Cadmium: accumulates with a half-life of 30 years and can damage the kidneys and cause cancer.
Mercury: is easily accumulated in organisms and concentrates through the food chain. It has chronic
effects and can cause brain damage. Chromium (Hexavalent): easily absorbed into cells with toxic
effects. The results can be allergic reactions, asthma and it is considered to be genotoxic (damages
the DNA). Especially dangerous when incinerated.
Brominated Flame Retardants: widely used to reduce flammability (e.g. cables, connectors and
plastic cases).
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21.
MAINTENANCE
CenterVue recommends the periodic maintenance of the components listed in the following table.
Only properly qualified CenterVue Authorized Service Technicians can perform calibration activities.
Contact your local CenterVue distributor or service center if you think your MAIA requires calibration.
TEST ITEM
TEST DESCRIPTION
ACCEPTANCE CRITERIA
TEST FREQUENCY
IN CASE OF FAILURE
Push-button
Enter the examination
screen, press the pushbutton at least 3 times,
once every 2 seconds.
The “Button” indicator
turns orange anytime
the button is pressed
Before
performing any
test
Push-button is not
working and no patient
response is detected.
Test results are affected.
Check proper insertion of
the push-button
connector in the MAIA
unit. If connection is OK
and the problem persists
contact Technical
Support.
Front lens
Visual check of front
lens external surface.
No presence of dust or
stains detected
Daily
Image quality is
adversely affected. Clean
the lens as explained at
section 14 of this
Manual.
Fixation target
Visual check of the red
fixation target during
the daily Stimulus
Projection System
check.
There should be a red
target like this:
Daily
The fixation target is not
working and test results
are affected. Contact
Technical Support.
Perimetric
stimulus
Visual check of the
white stimulus during
the daily Stimulus
Projection System
check.
The white dot center
should be inside the
external border of the
fixation target (see Fig.
18)
Daily
The stimulus projection
system is not working
(damaged or not
calibrated) and test
results are affected.
Contact Technical
Support.
Patient data
Backup the patient
database on an external
USB media.
The backup procedure
completes successfully.
Weekly
External media could be
corrupted (use a
different media) or USB
connection is faulty. If
problem persists, contact
Technical Support.
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TEST ITEM
TEST DESCRIPTION
ACCEPTANCE CRITERIA
TEST FREQUENCY
Speaker
Enter the examination
screen, start exam and
proceed until the
stimuli projection
begins, then remove
the patient.
The tracking alarm starts
(make sure it is not
muted)
Monthly
Either the speaker or the
amplifier is not working.
Contact Technical
Support.
USB ports
Connect a USB mouse
to each of the two USB
ports.
Pointer on screen should
move with mouse
Yearly
The USB port is not
working. Contact
Technical Support.
Ethernet port
Connect MAIA to a LAN
cable, enter the
Settings and configure
the network as
explained at Par. 11.3.
See Par. 11.3
Yearly
The LAN connection is
not active or the internal
network board is not
working. Contact
Technical Support.
Cooling fan
Turn ON the MAIA and
verify that the cooling
fan is working.
Fan noise should be
heard near the LCD
Yearly
The fan is not working
and may affect
embedded PC operation.
Contact Technical
Support.
Stimulus
Projection
System
Request the periodic
inspection, greasing
and calibration of the
Stimulus Projection
System by a CenterVue
Authorized Service
Technician.
Calibration procedure
completes successfully.
Once every two
years
The Stimulus Projection
System must be replaced
and calibrated.
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IN CASE OF FAILURE
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APPENDIX A: MAIA grids XML format
Custom MAIA grids can be created, defining as many projection locations as desired. The position of each
location can be expressed in Cartesian or Polar coordinates, as desired.
The grid shall be defined in XML format, which describes a tree of nested nodes. Each node can have child
nodes and/or attributes). Each XML node can be expressed in two ways:
1) with opening and closing tags (i.e. <node> and </node>): mandatory if it has child nodes
2) with the “/>” closing tag, if it has no child nodes (i.e. <node attribute=”value” />)
The same XML file can contain the description of more than one grid: when importing it, all the contained
grids will be imported into the unit.
The main structure of the XML file shall be:
<!DOCTYPE MitPatterns>
<patterns>
<pattern_expert>
<Grid name="3° Circle plus center">
<Stimulus id="1" … />
<Stimulus id="2" … />
</Grid>
<Grid name="4° square grid">
<Stimulus id="1" … />
<Stimulus id="2" … />
</Grid>
</pattern_expert>
</patterns>
The first line (MitPatterns) is a header. The main node (“patterns”) is the root node of the XML, and
shall contain the “pattern_expert” node; for Scotopic test grids (used in S-MAIA), the tag
pattern_expert shall be replaced with pattern_scotopic. The pattern_expert and
pattern_scotopic nodes shall contain one Grid node for each defined grid.
The Grid node shall have a “name” attribute, containing the name given to the grid, that will be
displayed in the Grid selection interface (see par. 8.4.4). In the example, the “°” tag is used to
display the degrees ( ° ) symbol. Each Grid node shall then contain several Stimulus child nodes, each
one describing one stimulus location to be projected on the retina. Each Stimulus shall have a unique id
attribute: the id must be >0 (dedicated to the stimulus on the optic disk, used to calculate the Fixation
Losses index) and <1000 (dedicated to custom added stimuli, see par. 8.4.11).
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As said, each location can be expressed in two ways:
<Stimulus id="3" x_deg="2.5" y_deg="4.33" />
<Stimulus id="3" ray="5" angle_deg="60" />
Fig. 82 – Cartesian vs Polar coordinates
The above example shows two different ways to express the same location, referred to the grid center: the
first in Cartesian coordinates (x_deg, y_deg), expressed in retinal degrees; the second in Polar coordinates
(ray, angle_deg corresponding to r and θ in Fig. 82: ray is again in retinal degrees, while angle_deg is in
degrees measured anti-clockwise starting from the X axis).
The coordinates (0, 0) refer to the center of the grid, which will be projected over the PRL-i, unless the
“Change grid position” option is selected (see par. 8.4.10). All the coordinates refer to the RIGHT eye: when
examining the LEFT eye, the grid will be flipped horizontally. Stimuli locations cannot overlap (i.e., the
minimum distance between two stimuli is 0.5 degrees).
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APPENDIX B: RAW Data Export Tool
The RAW Data Export Tool allows to export the exams data on a USB drive in .txt files, using tab-separated
format. This format can be easily imported in spreadsheets applications like Excel for statistical analysis.
The Tool can be launched within the Settings – System menu (see par. 11.5). The tool shows a list of all the
patients stored in the DB (see Fig. 83). It is possible to select individual patients or to select them all with
the “Select All” button. A filtering field allows to filter the patient list. Once selected the desired patients,
the “Export data” allows to export all the exams related to the selected patients. An USB drive must be
plugged in the device before pressing the button. The progress bar will show the advancement of the
progress; at the end, an Information dialog will display the number of exams and patients that have been
exported.
Fig. 83 – RAW Data Export Tool interface
RAW data Export format
After pressing the “Export data” button, the tool will generate 3 types of file (in the file names, #SN#
represents the serial number of the device, #pID# the patient ID, and #eID# the examID):
a) maia-#SN#_patientsTable.txt : this is a table that contains the patient list, linking each patient
name with its ID, Code and SSN numbers (if used, see par. 11.1). If the data need to be sent for
statistical analysis anonymously, it is possible to just delete this file: all the other exported files
refer to the patient IDs, so they are anonymous.
b) For each exam, a maia-#SN#_#pID#_#eID#_threshold.txt and a maia#SN#_#pID#_#eID#_fixation.txt files, in the maia-#SN#_data/ subfolder : these contain the export
of the measured thresholds and of the fixation data, respectively.
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• maia-#SN#_#pID#_#eID#_*.txt header structure :
each of these files provides a header, containing the main exam results. In case of a Scotopic test, the
results values are divided in two columns, the first for the cyan exam and the second for the red exam
(refer to S-MAIA: Scotopic Test Manual). The header is divided in 3 parts:
1. Exam Info: provides the unit Serial Number, patient and exam IDs, strategy used, eye, exam date
and age of the patient, exam duration in sec., the pix2deg ratio (that allows to relate measures in
degrees with positions on the retinal image), the Fixation Losses index and the average reaction
time (in millisecs).
2. PRL Info: provides
- the average sensitivity (average of all thresholds measured);
- position of the PRL_i and PRL_f (divided in two rows: x and y, respectively. The values are
expressed in degrees, and are relative to the top-left corner of the retinal image: since MAIA field
of view is 36.5°x36.5°, the point [18.25,18.25] refers to the center of the image);
- the distance (in degrees) between the PRL initial and final;
- the Estimated Fovea Location (EFL), if set
- in case of a follow-up exam, the position of the PRL_i of the baseline exam in this exams, retinal
image, and the rototranslation values (in three rows: x shift, y shift and rotation, in degrees)
between the baseline and the follow-up: these allow to correctly position the stimuli on the retinal
image.
3. Fixation Results: provides the P1 and P2 indices, the 63% amd 95% BCEA area values (in squared
degrees) and their angle (in degrees)
• maia-#SN#_#pID#_#eID#_threshold.txt values :
after the header, the threshold files provide a table containing a list of the stimuli values: the ID (each
stimulus in a grid has a unique ID; the ID #0 refers to the stimulus placed in the optic disk, used to
calculate the Fixation Losses index), its X and Y coordinates (in degrees, and relative to the PRL_i
position), and the measured threshold at that location (this can be expressed in DBs for 4-2 strategy,
and in levels for the 4LF and Scotoma Finder strategies).
• maia-#SN#_#pID#_#eID#_fixation.txt values :
after the header, the fixation files provide the fixation data measured by the retinal tracking: only valid
points are exported (i.e., those for which the tracker gave a valid results, so blinkings are removed). The X
and Y coordinates are expressed in degrees and relative to the top-left corner of the retinal image. The
fixation points are divided in two sections:
1. Registration points: these are a list of the 250 fixation points acquired during the Registration phase,
and are the ones used to determine the PRL_i (which is an average of these points, after removing some
outliers). Each record shows X and Y coordinates and time (in milliseconds, from the beginning of the
Registration phase).
2. Fixation points: these are a list of all the other fixation points, acquired during the stimuli Projection
phase, and are the ones used to determine the PRL_f (which is an average of these points, after removing
some outliers). Each record shows X and Y coordinates and time (in milliseconds, from the beginning of the
Projection phase). In case a stimulus projection was occurring at that time, the related stimulus ID is
provided in the fourth column.
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