Essilor Instruments EyeViz 300 User manual

User manual

CONTENTS
I. INTRODUCTION 5
II. GENERAL WARNINGS 7
1. About this manual 8
2. Description of device 8
3. Types of warnings, cautions and notes 8
4. List of abbreviations 9
5. Symbols & Label 10
a. Symbols marked on the instrument 10
III. CONDITIONS FOR USE 11
1. Use 12
a. Intended use 12
b. Indications for use 12
c. Limitations of use 12
d. Contraindications 12
2. Safety 13
a. Electrical safety 13
b. EMC Compliance 13
c. Safety instructions 13
IV. SET UP THE SYSTEM 15
1. Power on and login to system 18
2. Shut down the system 19
3. Position the patient 20
4. Put on the glasses 21
5. Main menu 22
6. Settings screen 22
a. [Facility name] 24
b. [Date and zone time] 25
c. [Change password] 26
d. [Default mandatory subject info] 27
e. [Set modes] 28
f. [Categories] 29
g. [Language configuration] 31
h. [User logo settings] 33
i. [Visual acuity units settings] 34
V. SET UP THE TESTS 37
1. Overview of initial setup screen 38
2. Patient information 39
3. Tests to run 40
4. Tests settings 43
VI. RUN THE TESTS 45
1. Verify correct operation 46
USER MANUAL> CONTENTS

2. Start the tests 48
VII. TESTS RESULTS 49
1. Results 51
2. CT and ACT results key 53
VIII. MAINTENANCE & SERVICE 55
1. Maintenance 56
a. Determining the battery state 56
b. Led low battery indicator 56
c. Indicator on the lenses for low battery 56
d. Charging the battery 56
2. Clean and Disinfect 57
3. Service and repair policy 57
4. Warranty 57
IX. TROUBLESHOOTING 59
1. Error conditions 60
2. Error messages 61
X. SPECIFICATIONS 63
XI. QR CODE 65
USER MANUAL> CONTENTS

I. INTRODUCTION

The complete user manual is available on a web space.
To access other available languages, please scan the QR code at the end of this user manual >
Chapter QR code (F p.66).
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USER MANUAL> I. INTRODUCTION

II. GENERAL WARNINGS

1. ABOUT THIS MANUAL
This user manual provides the information necessary to operate and maintain the EyeViz300 assessment
system.
Please read this user manual before operating the system. If any part of this user manual requires
further explanation, contact customer support for assistance.
Please retain this user manual for future reference.
2. DESCRIPTION OF DEVICE
The product is intended for use by a health care professional and requires no special training to operate
other than reading the user manual, which includes comprehensive explanations regarding system operation
and handling of various errors and warnings.
The system is based on eye tracking technology, which provides constant information regarding the position
of the patient's eyes. Near-infrared illumination is used to create reflection patterns on the cornea (glint) and
pupil of the eye of the patient, and these reflections are detected by capturing images using an infrared
camera.
Following detection, a vector formed by the angle between the cornea and pupil reflections is calculated—the
direction of this vector, combined with other geometrical features of the reflections, is then used to calculate
the gaze direction. Advanced image-processing algorithms and a physiological 3D model of the eye are then
used to estimate the position of the eye in space and the point of gaze with high accuracy.
To perform the deviation tests, a special pair of glasses is used which, when controlled via the EyeViz300
software, can enable alternating covering and uncovering of each eye similarly to the traditional cover test.
For the tests where a 3D image appearance is required, or where a dichoptic test is used, red-cyan anaglyph
glasses are used. The physician interacts with the system through the EyeViz300 user interface. The patient
puts on the testing glasses and follows a visually stimulating target on the screen. No language or verbal
skills are needed in order to perform the test. Once the test is completed, the test results are provided and
can be recorded for future reference.
Product regulatory reference : EVZ1IN
3. TYPES OF WARNINGS, CAUTIONS AND NOTES
Three types of special message appear in this user manual:
Warning
A warning indicates precautions to avoid the possibility of personal injury or death.
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USER MANUAL> II. GENERAL WARNINGS

Caution
A caution indicates a condition that may lead to damage to equipment, or a lower quality of treatment.
Note
A note provides other important information.
4. LIST OF ABBREVIATIONS
User Test operator
Dev. eye/ Deviating/ DE Deviating eye (in strabismus measurement)
R Right
L Left
A Alternating
CT Cover Test
ACT Alternating Cover Test
H Horizontal
V Vertical
Dist. Distance
ID Identification
SC Sans Correction (no refractive correction)
CC Con Correction (with refractive correction)
OD Oculus Dextrus (Right Eye)
OS Oculus Sinister (Left Eye)
PD Pupillary Distance
DOB Date of Birth
VA Visual Acuity
CS Contrast Sensitivity
S Small
M Medium
L Large
Eso Towards the nose
Exo Outwards from the nose
Hypo Too low
Hyper Too high
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5. SYMBOLS & LABEL
a. Symbols marked on the instrument
Refer to operation manual
It means that, for safety reasons, you need to consult the instruction manual
before using the device
"CE marking” that attests to product compliance with European Union Directive
93/42/EEC (Medical Devices) and following amendments
Indicates the obligation to collect and separate disposal of electrical and
electronic equipment, at the end of their useful life, according to 2012/19/EU
Manufacturer serial number
Manufacturer catalogue number
Date of manufacturing
Manufacturer
Authorized Representative Information
FCC symbol
QR code
RoHS compliance
Warning
This side up
Fragile
Keep dry
Recyclable
Type BF (B = Body, F = Floating applied part) applied part
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USER MANUAL> II. GENERAL WARNINGS

III. CONDITIONS FOR USE

1. USE
a. Intended use
The EyeViz300 is intended for the automated and manual detection of parameters related to ocular and
visual function and is intended to be used by a health care professional.
b. Indications for use
The EyeViz300 is indicated for:
1. Detection of a deviating eye
2. Automated assessment of heterophoria and heterotropia in the primary eye position at near and far
3. Automated detection and assessment of fusional divergence and convergence
4. Automated detection of pupillary distance
5. Automated assessment of visual acuity at near and far
6. Manual detection of visual acuity at near and far
7. Presentation of a Worth 4-dot test
8. Manual detection of color vision impairments
9. Manual measurement of stereoacuity
10.Automated analysis of reading patterns
The EyeViz300 is indicated for use in patients over the age of 6 months who are responsive to taking
direction and who can pay attention for at least 3 minutes as part of an evaluation in a professional eye care
setting.
c. Limitations of use
Clinical situations potentially affecting device accuracy or performance include the following:
•Testing is not recommended for babies under the age of 6 months
•Testing while patient wears glasses with high refractive index may cause assessment difficulties,
leading to increased assessment time
•If the patient is wearing bifocals, instruct them to use the appropriate part of the bifocal glasses, the
near segment of the bifocals for the near tests, and the distance segment for the far tests
•Multifocal glasses may cause issues with eye detection by the eye tracker
Patient movement and fidgeting may lead to difficulty in completing testing.
d. Contraindications
•Significant neurological or behavioral problems
•Patients with only one eye
•Patients whose binocular visual system has not yet fully developed
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USER MANUAL> III. CONDITIONS FOR USE

2. SAFETY
a. Electrical safety
The device complies with requirements of IEC/EN 60601-1 for general requirements for safety of medical
electrical equipment:
•Class I Equipment BF type applied part
•Mode of operation: continuous assessment
•Degree of mobility: portable
b. EMC Compliance
The unit has Class B compliance.
c. Safety instructions
Warnings
•Do not use before reading and understanding this user manual.
•The product's system is intended for indoor operation.
•Do not use the product beyond the declared environmental conditions. Operation outside of
these limits can lead to incorrect assessment.
Cautions
Factors that may affect the accuracy of the assessment include the following:
•Eyeglasses with high refractive index
•Extraneous movements or excessive fidgeting of patient
•Clean the device before applying it to a new patient.
•The system should be placed on a stable surface in order to avoid any risk of harm or damage
to the patient
•Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids
into the device.
•If the system overheats, contact customer service.
•Do not expose the product to excessive moisture such as direct exposure to rain. Excessive
moisture can cause the device to perform inaccurately or fail.
•Do not expose the product to temperatures outside of the normal operating range, as this may
cause the device to perform inaccurately or fail.
•This device is a precision electronic instrument and must be repaired by Essilor qualified
technical professionals. Field repair of the device is not possible. Do not attempt to open the
case or repair the electronics. Opening the case may damage the device and void the warranty.
•Follow relevant government regulations regarding disposal or recycling of the device and device
components, including batteries.
•In compliance with the European Directive on Waste Electrical and Electronic equipment (WEEE)
2012/19/EU, do not dispose of this product as unsorted municipal waste.
•This device contains WEEE materials. Please contact your distributor regarding return or
recycling of the device. If you are unsure how to reach your distributor, please call Essilor for
your distributor's contact information.
•Do not disassemble any part from the device.
•This device is not user-serviceable.
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IV. SET UP THE SYSTEM

The components of the EyeViz300 system are shown below.
EyeViz300 system with:
•Tablet PC: displays user interface and displays
targets to patient during tests
•Eye tracker: records eye position
•Infra-red emitter: controls lens shutters of the
glasses
IR glasses (worn by patient)
Anaglyph glasses (worn by patient)
Before using the system, please check that the following components are properly prepared and connected.
Connect the power adaptor to AC power.
Make sure that the system display is clean.
Wipe if necessary with a damp cloth.
Check the glasses.
Check that the glasses are clean and in proper working order.
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Disinfect the glasses between patients, as described in section [Clean and Disinfect].
Please see section [Service and Maintenance] for instructions to check that the battery is properly
charged.
Do not remove or tamper with the red stickers found on the front of the glasses.
These stickers are important for the correct functioning of the internal distance correction system.
Turn on the glasses.
There is no need to turn on the glasses. The glasses will wake automatically when the system loads.
On wake up the glasses will display three fast blinks and the LED will turn on for several seconds.
If the glasses do not signal wakeup, press the button (1) once. The red LED will turn on.
Turn off the glasses.
There is no need to shut down the glasses. The glasses will shut down automatically when the system is
not in use.
If you do wish to manually shut down the glasses, press the button (1) until the red LED will flash for a
moment and then turn off. The glasses will then shut down.
In addition to the LED indicator, when powering down the glasses, the glasses will display a long blink
and open both lenses.
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Low battery indication: The following indications are shown in case of low battery. The LED will
blink on and off.
If the glasses are in sleep mode, the lenses will also blink open and closed.
Prepare the IR front panel.
Check that the front IR panel is clean and unobstructed.
Wipe if necessary with a lens cleaning cloth.
1. POWER ON AND LOGIN TO SYSTEM
To start the system, press the power on button on the top of the system.
Contact customer service if the system does not turn on after the power supply has been checked.
The login screen will be displayed.
>
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USER MANUAL> IV. SET UP THE SYSTEM

Please enter the user name and password that are defined for your system.
•The default user name is [Admin].
•The default password is [1234].
If the system does not display this screen, or if other errors occur during system startup, check
that the system components are connected properly.
If the system still does not work properly, please contact customer service.
If the touch-screen or other functionality does not work properly, please contact customer service.
2. SHUT DOWN THE SYSTEM
After you have run the desired tests and viewed the results, you may shutdown the system by pressing
[Power] on the main menu:
The program will close and the system will shut down.
Contact customer service if the system does not turn off.
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3. POSITION THE PATIENT
It is very important to assure that the patient maintains the correct head position for the duration of
the test. Improper head position may lead to incorrect results.
The patient's head must be maintained in the primary position. If the patient cannot maintain this position
independently, the operator should correct the head position and maintain it for the duration of the test.
The patient must be at the correct height and centered in front of the screen.
This can be confirmed by observing the indicators on the top right of the screen. When correctly positioned,
the indicators should appear as follows:
Centered and correct height Correct distance
Small children can be seated on their mother's lap.
Correct placement of device, with the patient sitting directly in-front of the system at a distance between 50
and 80 cms.
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4. PUT ON THE GLASSES
Make sure the glasses have sufficient battery before wearing.
Then, turn on the glasses by pressing the on/off switch, as shown below:
1. Button on, off, pairing, located on the inner
side of the right earpiece
2. LED, located on the outer side of the right
earpiece, near the earpiece hinge
Proper placement of the glasses
Glasses should be placed on top of the patient's prescription glasses. When putting on the glasses, make
sure that the glasses do not slip down the nose.
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5. MAIN MENU
Press on the icon to view the main menu:
1. [User Name]
Enter the user name that will identify this session.
2. [Settings]
View and change the settings.
3. [Service]
Enables the support team to analyze and fix issues with the system.
4. [Power]
End the session and shut down the system.
6. SETTINGS SCREEN
To access the settings screen, you must select settings from the menu on the top panel. A dialog box will
open where you are required to enter the admin user name and password.
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