Essilor Instruments Retina 550 User manual

www.essilor-instruments.com
User manual

CONTENTS
I. INTRODUCTION 5
1. Symbols 6
a. Device symbols 7
2. General warnings 7
3. Normative references 7
a. Community directives 7
b. Technical standards 7
c. Quality management systems standards 8
4. Warranty 8
5. Manufacturer identification 9
II. SAFETY 11
1. Safety warnings 12
2. Device identification plate 12
3. Intended use 13
4. Medical devices classification 14
5. Medical electrical devices classification 15
6. Environmental conditions 15
7. Disposal at the end the useful life 16
8. Manufacturer declarations 17
a. Electromagnetic emissions 17
III. DEVICE DESCRIPTION 19
1. Provision description 20
a. Device Retina550 21
b. Power supply 21
c. Chinrest (optional) 21
d. Electric table (optional) 22
2. Optional accessories 22
3. Technical data 22
IV. DEVICE USE 23
1. How to install the device 24
2. How to connect the device 26
3. How to turn on the device 27
4. How to adjust the chinrest 28
5. How to acquire the image 29
6. How to change the paper for chin cup 31
7. How to turn off the device 31
V. ORDINARY MAINTENANCE 33
1. Safety warnings 34
2. Device cleaning 34
USER MANUAL> CONTENTS

I. INTRODUCTION

The complete user manual is available on a web space. To access, please scan the QR code below
using a dedicated application.
Le manuel utilisateur complet est disponible sur un espace web. Pour y accéder veuillez scanner
le QR code ci-dessous à l'aide d'une application dédiée.
The device is the result of a long research period, conducted by experts to give the best union of technical
innovation, quality and design.
The device can be easily used thanks to the guided manual acquiring an the electrical control of the service
functions.
1. SYMBOLS
Within the instructions for use, on the package or on the device, there can be the following symbols:
Symbol Meaning
General danger
Electric shock danger
Obligation. Read the instructions for use
General obligation
Note: Useful information for the user
Prohibition: Forbidden operation
Manufacturer
CE marking (European Regulation on Medical Device)
Symbol of the waste disposal in compliance with the Directive 2012/19/EU (WEEE), and
2011/65/EU (RoHS II)
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USER MANUAL> I. INTRODUCTION
El manual de uso completo está disponible en la web. Para acceder, escanee el código QR que se
encuentra a continuación con la ayuda de una aplicación.

a. Device symbols
Symbol Meaning
Applied part of type B
Class II device
2. GENERAL WARNINGS
These instructions refer to the model Retina550 ("Device" from now on).
The original manual is in italian.
This device is compliant with marking. Date of first marking: June 2017
Before using the device or if you don't use it since a long time, read these instructions carefully.
Read the instructions given in the instructions manual and reported on the device.
Keep this manual close by for future consultation. If you should decide to sell this appliance to
other people, remember to also include these instructions, complete and readable.
We suggest you keep the original box and packaging, as our free-of-charge service does not
cover any damage resulting from inadequate packaging of the product when this is sent back to
an authorized Service Center.
Verify the presence of damage signs on the device caused by the transport/storage, before using
the device.
It is forbidden to reproduce, totally or partially, texts or images contained in these instructions
without the written authorization of the manufacturer.
The manufacturer reserves himself the right to modify the contents of the instruction for use,
without notice.
3. NORMATIVE REFERENCES
a. Community directives
•Directive 93/42/EEC concerning medical devices.
•Directive 2012/19/EU on waste electrical and electronic equipment (WEEE).
b. Technical standards
•IEC 60601-1 and 3.1: Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance.
•EC 60601-1-2 - edition 4 Collateral Standard: Electromagnetic disturbances - Requirements and tests.
•ISO 15004-1: Ophthalmic Instruments. Fundamental requirements and test methods - Part 1:
General requirements applicable to all ophthalmic instruments.
•ISO 15004-2: Ophthalmic Instruments. Fundamental requirements and test methods - Part 2: Light
hazard protection.
•ISO 14971: Medical devices. Application of risk management to medical devices.
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c. Quality management systems standards
•ISO 9001:2008 Quality management systems - Requirements.
•ISO 13845:2012 Medical devices. Quality management systems - Requirements for regulatory
purposes.
4. WARRANTY
The manufacturer is responsible for the device conformity to the Community directive 93/42/EEC as
amended by the 2007/47/EC for:
•Features
•Safety and reliability
•CE marking
The manufacturer refuses any responsibility for:
•Installation and activation not activated in conformity to the indications and the precautions reported
in the instructions for use.
•Use not in compliance with the instructions and precautions reported in the instructions for use.
•Use of accessories or spare parts not provided or suggested by the manufacturer.
•Repairs and safety controls not effectuated by expert, qualified, trained and personnel authorized by
the manufacturer.
•Electrical system of the space where the device is installed not in compliance with the technical
standards, the laws and regulations in effect in the country of installation of the device.
•Direct or indirect consequences or damages to objects or persons, originating for the improper use of
the device or erroneous clinical analysis originating from its use.
The manufacturer guarantees the device for 24 months after invoicing. The warranty includes the
substitution, at the manufacturer's or an authorized Service Center, of components and materials and the
labor. The shipping and transport fees are to be paid by the client.
It the warranty are not included:
•Reparations of faults originating from natural disasters, mechanical shocks (fall, hit, etc), electrical
system faults, negligence, improper use, maintenance or reparations carried out with non original
materials.
•Any other improper use or not intended by the manufacturer.
•Damages caused by service lack or inefficiency, originating by causes or circumstances out of the
manufacturers control.
•The parts subject to usage and/or deterioration originating from the normal use and those that might
be broken because of an improper use or maintenance carried out by personnel non-authorized by the
manufacturer.
To ask maintenance interventions or to have technical information about the device, address to a technical
assistance center or directly to the device manufacturer.
The client will not be refunded for damages originating from the device halt.
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5. MANUFACTURER IDENTIFICATION
ESSILOR INTERNATIONAL
Instruments Division
147 rue de Paris
94220 Charenton le Pont
FRANCE
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II. SAFETY

1. SAFETY WARNINGS
Electric shock danger. Do not let water fall on the device. Do not immerse the device in water or
other liquids.
Electric shock danger. If the power cables are damaged they must be replaced to prevent any
risk.
Electric shock danger. Unplug the power cable from the mains socket before disinfecting the
device and before any maintenance operation.
Do not use the device if visibly damaged. Periodically inspect the device and the connection
cables to verify if there are damage signs.
Always keep the device out of the reach of children.
Danger of device fall. Do not let the power cord hang in a place where it could be grasped by a
child.
If you notice a wired odor or smoke coming out of the appliance or if it emanates heat, suspend
immediately the use. Keep using a damaged product, or a damaged part, may cause injuries.
It is forbidden to carry out any technical operation on the device that is not recalled or described
in these instructions for use.
It is forbidden to place the device in humid, dusty places or environments subject to sudden
temperature and humidity variations.
It is forbidden to use any extension cable not authorized by the manufacturer.
It is forbidden to use the device outdoors.
The device does not generate and does not receive any electromagnetic interference if it is placed
near other electrical appliances. No preventive or corrective actions are required.
2. DEVICE IDENTIFICATION PLATE
Device data plate Plates position
With:
A: Device data plate
B: Software version plate
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Power suppliers data plate
3. INTENDED USE
The device Retina550 is a medical electrical device for the non-mydriatic fundus camera.
The device has been designed for the screening, the acquisition and the elaboration of an image of the retina
in the ophthalmic procedure. The device provides a clear and detailed vision of the whole image of the funds
with a real 60°x45° field of view. The device processes retinal images with a minimum flash exposition,
minimizing the discomfort for the patient. The device acquires the image of the retina even when the pupil is
constricted.
The device, with the software allows:
•A guided manual acquisition
•To manage the patients data and to effectuate personalization of researches and statistics
•Acquire simultaneously images in white light mode and IR mode
•Analysis of panoramic images on large field
•Image processing, drawing, measure
•Zoom effects
•Vertical and horizontal cup/disc
•Color control and filters simulation
•Overlay on the image
•Edge enhancement
•Contrast and luminance control and control of each RGB component and range correction
•Image in grayscale, ref fee, and channel separation
•Image with inverted colors
The device must be used only by practitioners, optometrist and opticians, within the limits of the law and the
regulations for the exercise of the profession.
The device must be used in combination with a PC and the software denominated AnaEyes.
Hardware minimum requirements:
•PC Desktop with processor Intel Pentium Dual Core
•1 GB RAM (2 GB suggested for Windows Vista, Windows 7 and Windows 10)
•USB3.0
•Video board with 512 MB RAM (not shared) and minimum resolution 1280 x 1024 pixels
Software requirements:
Operating systems: Microsoft Windows XP Home, Windows XP Professional, Windows Vista (32 bits) Home
premium, Windows 7 (32 and 64 bits), Windows 10 (32 and 64 bits).
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Read the instructions for use of the software.
The PC must be compliant to the norm IEC 60950-1 Information technology equipment - Safety -
Part 1: General requirements.
If the PC is installed in the patient area it is necessary to install an isolation electrical supply
compliant with the directive IEC 60601-1 and 3.1 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.
It is possible to connect other accessories to the PC (printer, modem, scanner, etc) through the
analogical or digital interfaces.
The accessories (printer, modem, scanner, etc) must be installed outside the patient area.
The accessories must be compliant to the norm IEC 60950-1 Information technology equipment -
Safety - Part 1: General requirements.
If the accessories are installed in the patient area it is necessary to install an isolation electrical
supply compliant with the directive IEC 60601-1 and 3.1 - Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance.
Patient are is the volume in which the patient can come into contact (intentional or not, direct or
through the operators) with medical electrical an other devices.
4. MEDICAL DEVICES CLASSIFICATION
Technical data Value
Classification in compliance with the attached IX to the
Directive 93/42/EEC and successive modifications Class IIa
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5. MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification in compliance with the technical specification EN 60601- 1 (3rd edition).
Technical data Value
Type of protection against the direct and indirect
contacts Class II
Applied parts Type B
Protection degree against humidity IPX0 (no protection against liquid or solid
infiltration)
Sterilization or disinfection method This device can be disinfected
Protection degree in presence of anesthetics or
inflammable detergents No protection
Electrical connection degree between device and patient Appliances with part applied on the patient
Use conditions Continuous functioning
6. ENVIRONMENTAL CONDITIONS
Phase Technical data Min Max
Transport
Temperature -40°C +70°C
Atmospheric pressure 500 hPa 1060 hPa
Relative humidity 10% 95%
Storage
Temperature -10°C +55°C
Atmospheric pressure 700 hPa 1060 hPa
Relative humidity 10% 95%
Use
Temperature +10°C +35°C
Atmospheric pressure 800 hPa 1060 hPa
Relative humidity 30% 90%
Danger of device damages. During transport and storage, the device can be exposed to the
environmental conditions for a maximum period of 15 weeks, only if kept in the original packaging.
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7. DISPOSAL AT THE END THE USEFUL LIFE
Instruction for disposal of product correctly according to European Directive 2012/19/EU, and
2011/65/EU about the reduction of use of dangerous substances in the electrical and electronic
equipments, and waste disposal.
At the end of its useful life, the device must not be disposed of as urban waste. The device can be
delivered to the appropriate separate waste collection centers set up by municipal administrations or
to retailers that offer this service. Separately disposing an electrical device prevents possible
negative consequences for the environment and health caused by its improper disposal, and lets the
materials it is made of to be recycled so as to achieve a significant savings of energy and resources.
On the label of the device there is the symbol of the of the crossed-out wheeled bin. The graphic
symbol of the crossed-out wheeled bin, indicates the obligation to collect and dispose separately the
electrical and electronic equipments at the end of their useful life.
The user has to consider the effects potentially dangerous for the environment and the human health
originating from an improper disposal of the whole device or its parts.
To avoid the introduction of dangerous substances in the environment and to encourage the preservation of
natural resources, the manufacturer facilitates the possibility of reusing and recycling the device or the
materials contained in the device if the user decides to dispose it at the end of its useful life. Before
disposing the device it is necessary to take into consideration the European and national regulations that
order:
•Not to dispose the device as urban waste, but collect it separately and address to a firm specialized in
the disposal of electrical and electronic equipments or to the local administration in charge for waste
collection.
•In case a new device with the same functions is purchased, at the same manufacturer, to replace an
used one put on the market before the 13th August 2015, the supplier or the manufacturer have to
collect the old device.
•If the user decides to dispose a used device, put on the market after the 13th August 2005, the
supplier or the manufacturer have to collect it.
•The manufacturer takes care, by joining a consortium for the technological devices waste, of the
treatment and the recycling of the used device by paying its costs.
The manufacturer is available to give the user all the information about the dangerous substances
contained in the device, and on the recycling modalities of those substances and about the
possibility of a reuse of the used device.
Strict sanctions for transgressors are provided for by law.
For specific information about the disposal in other countries than Italy, contact the local supplier.
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8. MANUFACTURER DECLARATIONS
a. Electromagnetic emissions
The device is designed to be used in a room with the following electromagnetic characteristics:
Emission test Compliance Electromagnetic environment
Radio frequency emission. CISPR 11 Group 1
The device uses radio frequency energy only for its
inner functioning. The radio frequency emissions of
the device are very low and should not cause
interferences with the near appliances.
Radio frequency emission. CISPR 11 Class B
The device can be used in all the environments,
included the domestic environment. The device can
be connected directly to a low tension power supply
net as there is in the housing units.
Harmonic emissions. IEC 61000-3-2 Class A /
Limitation of voltage changes, voltage
fluctuations and flicker. IEC 61000-3-3 Compliant /
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Immunity test IEC 60601-1-2 test level Compliance Electromagnetic environment
Electrostatic discharge
IEC 61000-4-2
8kV contact 2/4/8/15 kV
air
IEC 60601- 1-2
Test level
Floors should be wood, concrete
or ceramic tile. If the floors are
covered with synthetic material
the relative humidity should be at
least 30%.
Radiated electromagnetic
fields
IEC 61000-4-3
3V/m 80 MHz to 2.7 GHz IEC 60601- 1-2
Test level
Portable and mobile RF
communication equipment should
be used no closer to any part of
the device, including cables.
Minimum distance 30 cm.
Electrical fast transient/burst
IEC 61000-4-4
2kV for power supply lines
1kV for input/output
lines > 3 m
IEC 60601- 1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
0.5/1kV differential mode
0.5/1kV common mode
IEC 60601- 1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment.
Conducted disturbances,
inducted by RF fields
IEC 61000-4-6
3 V 150 kHz to 80 MHz IEC 60601- 1-2
Test level
Portable and mobile RF
communication equipment should
be used no closer to any part of
the device, including cables.
Minimum distance 30 cm.
Voltage dips. Short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
0% Un for 0.5 cycle
0% Un for 1 cycle
70% Un for 25 cycles
0% Un for 5 s
IEC 60601- 1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the device requires continued
operation during power mains
interruptions, it is recommended
that the device is powered from
an uninterrupted power supply or
battery.
Power frequency (50/60Hz)
magnetic fields
IEC 61000-4-8
30 A/m IEC 60601- 1-2
Test level
Power frequency of the magnetic
fields should be that of a typical
commercial or hospital
environment.
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III. DEVICE DESCRIPTION

1. PROVISION DESCRIPTION
With:
No. Denomination Description
1 Chinrest (optional) Adjustable height, adjustable distance between chin and forehead.
2 Protection carter Protection against accidental hand crushing.
3 Power supplier /
4 Device Retina550 Composed by a camera unit equipped with microcamera for the image
acquisition an a firewire cable compatible with the device.
5 Software Acquisition and image handling software.
6 Protective cover (optional) Place on the device when it is not in use to protect it from dust.
7 Set of hex keys with screws /
8 Package of paper for chin cup /
9 Electric table (optional) Adjustable electric support surface with one or two columns. Drawer
and auxiliary sockets with desk grommet.
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a. Device Retina550
1. Device Retina550
2. Joystick
3. Device blocking knob
4. Cogged wheels
5. Shooting channel
6. Device power cable
7. Power IN
8. USB connection cable between device and PC
b. Power supply
1. Data plate
2. Power supply
3. Supply control light
4. ON/OFF switch
5. Power OUT
6. Supply outlet
7. Power supply cable
8. Device power cable
c. Chinrest (optional)
1. Chinrest support
2. Handle
3. Knob
4. Chin cup
5. Forehead rest
6. Chinrest structure
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d. Electric table (optional)
The electric table can be provided in different models. The electric table is composed by a support surface on
which the cogged guides are built. One or two telescopic columns, motorized, allow to adjust the height of
the support plane.
Read the instructions for use of the electric table.
2. OPTIONAL ACCESSORIES
Denomination Description
Isolation transformer 230V/230V for the use of the non electromedical appliances in
the patient area
For the list of accessories and available models contact the manufacturer or the local supplier.
3. TECHNICAL DATA
Technical data Value
Working distance 20 mm
Resolution 2448x2051
Electrical supply (tool)
Switching power supply
PSP2402 input 100-240Vac output 24Vac
PSP2404 input 100-240Vac output 24Vac
Weight 7 Kg
Size 300x400x410 mm
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IV. DEVICE USE