UM RETINA400
V2‐ MARCH 2016
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USER MANUAL
FUNDUS CAMERA
Contents
1. General warnings ............................................................................................................................ 3
1.1 Symbols .................................................................................................................................. 3
1.2 Intended use and instructions for use ................................................................................... 3
1.2.1 Classification ...................................................................................................................... 4
1.2.2 Environment conditions .................................................................................................... 4
1.2.3 Reference standards .......................................................................................................... 5
1.2.4 Warranty ............................................................................................................................ 5
1.3 Safety precautions ................................................................................................................. 7
1.4 End‐of‐life disposal information ............................................................................................ 8
2 System Components........................................................................................................................ 9
2.1 ID PLATE ............................................................................................................................... 11
3 Routine maintenance .................................................................................................................... 11
4 Instructions for use........................................................................................................................ 12
5 Technical specifications ................................................................................................................. 13
6 Installation ..................................................................................................................................... 14
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1. General warnings
These instructions describe the correct use of the system/instrument Fundus Camera Retina400.
ATTENTION!
Please read this manual carefully before using the equipment
All ESSILOR products are manufactured with maximum attention to reliability and safety. In order to
use it efficiently and in complete safety we recommend reading this manual carefully before
installation and use and heeding all the safety warnings contained in herein and reported on the
exterior of the equipment. Even operators who have already used this type of instrument should
verify their knowledge of the instructions contained in this manual. Keep this manual near the
instrument for handy reference during use.
This device is considered a medical device. It should be utilized by authorized personnel only.
1.1 Symbols
Explanation of the graphic symbols used:
1) Applied parts classified as Type B in accordance with EN 60601‐1 standard.
2) Device of class II (according to EN 60601‐1). It means that the insulation to
the power supply is highly trustworthy and there is therefore no need for 1
earthing to guarantee security
3) General warning of the duty to read the instruction manual carefully before 2
installing and using the equipment
4) “CE marking” that attests to product compliance with European Union 3
Directive 93/42/EEC (“Medical Devices”) and following amendments.
Date of first Marking Jan 2014 4
5) 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
6) Manufacturer 5
1.2 Intended use and instructions for use
Retina400 is an electro‐medical system that allows for digitally retrieving, acquiring and processing of
a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent
to the professional activity of other operators, optometrists and opticians, to the extent permitted by
the laws and regulations for the exercise of their profession.
An absolute new entry in the field for retinal imaging, the instrument allows for a direct, ‘live’
monitoring on the computer screen, and capturing also in cases where the pupil diameter is
extremely narrow. The instrument, with manual acquisition and electronically guided control
guarantees high precision and repeatability of the measurements.
The dedicated software has the following characteristics:
Manual guided acquisition system;
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Simultaneous visible (‘white’) light and IR acquisition;
Panoramic analysis for enlarged field of view;
Image processing, drawing and measuring
Zoom effects
Cup/disc horizontal and vertical;
Image overlay;
Edge enhancement;
Contrast, brightness and RGB components settings and gamma correction;
Image color splitting (grey‐values, red free, channel separation);
Color inversion and filter simulation;
For more detailed information on dedicated software, we refer to the User manual.
1.2.1 Classification
Classification MEDICAL DEVICES
Classification of the device according to rules as of appendix IX of Directive 93/42/EC and
following amendments: class I
Classification ELECTROMEDICAL DEVICES
Class of protection against direct and indirect contact: class II
Applied parts: Type B
Compliance level for protection against humidity: Common devices (shell not protected)
IP20
Method of sterilization or disinfection: Disinfectable devices
Compliance level for protection in the presence of inflammable anesthetics: No protection
Degree of electrical connection between the unit and patient equipment with Patient
Applied Part
RETINA400 cameras fall into the category of class II, so the earth connection and the plug
earth are functional earthing.
1.2.2 Environment conditions
As long as the system components remain in their original packing the equipment may be exposed to
the environmental conditions listed below, for a maximum of 15 weeks during shipping and
warehousing, without suffering damage.
Environment conditions for operation:
Temperature between ‐10 °C and +35 °C
atmospheric pressure between 800 hPa and 1060 hPa
relative humidity between 30% and 90%.
Environment conditions for warehousing:
Temperature between ‐10 °C and +55 °C
atmospheric pressure between 700 hPa and 1060 hPa
relative humidity between 10% and 95%.
Environment conditions for shipping:
Temperature between ‐40 °C and +70 °C
atmospheric pressure between 500 hPa and 1060 hPa
relative humidity between 10% and 95%.
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Vibration, sinusoid 10 Hz @ 500 Hz, 0.5g
Shock 30g, duration 6ms
Bumb 10g. duration 6ms
1.2.3 Reference standards
The following reference standards were applied in design, production, and testing of the product:
EU Directives
DIRECTIVE 93/42/EEC “MEDICAL DEVICES ” , amended by 2007/47/EC.
DIRECTIVE 2012/19/UE “Waste Electrical and Electronic Equipment (WEEE).”
DIRECTIVE 2011/65/UE: “ROHS Directive”
Standards concerning Quality Management Systems :
EN 60601‐1 ‐ “MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR
SAFETY." 2006 edition as amended.
EN 60601‐1‐2 ‐ “Medical Electrical Equipment – Collateral Standard: Electromagnetic
Compatibility.” 2007 edition.
UNI EN ISO 15004‐1 “Ophthalmologic Instruments – Fundamental Requirements and Test
Methods – Part 1: General requirements applicable to all ophthalmic instruments.” 2007
edition
UNI EN ISO 15004‐2 “Ophthalmologic Instruments – Fundamental Requirements and Test
Methods – Part 2: Light hazard protection” 2007 edition
UNI EN ISO 14971:2012 “Risk Management for Medical Devices.”
Guidance for Industry and FDA Staff ‐ Guidance for the submission of Premarket
Notifications for Medical Image Management Devices (July 27, 2000)
Guidance for Industry and FDA Staff ‐ Guidance for the content of premarket submissions
for software contained in medical devices (May 11, 2005)
UNI EN ISO 9001:2008 “Quality Management Systems – Requirements.”
UNI EN ISO 13485:2012 “Medical Devices – Quality Management Systems ‐ Clinical
Requirements for Regulatory Compliance.”
1.2.4 Warranty
The Manufacturer is responsible for compliance with Directive 93/42/CE as amended by 2007/47/CE,
its performance, safety and reliability, and the CE marking. Device lifetime : 10 years
Nevertheless Manufacturer denies such responsibility when:
the installation and commissioning are not made in accordance with the instructions and
precautions given in this manual;
the device is not used in accordance with the instructions and precautions in this
manual;
spare parts and accessories not supplied or recommended by Manufacturer are used;
repairs and safety checks are not carried out by competent personnel, qualified, trained and
authorized by Manufacturer;
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the electrical installation of the room in which the appliance is not in compliance with CEI
and
laws and regulations.
Manufacturer disclaims any liability for direct or indirect consequences or damages to persons or
property, resulting from improper use or incorrect clinical evaluation of its use
Parts subject to wear and/or deterioration in normal and parts damaged by improper use or
maintenance performed by persons not authorized by Manufacturer are not covered by this
warranty.
To request technical assistance with maintenance, please contact directly your local technical center
or your distributor.
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1.3 Safety precautions
ATTENTION!
Never touch the power cord with wet hands. Check frequently that
the cord is so placed as not to be stepped on or crushed by
weights. Never knot the cord.
THE PERSONAL COMPUTER
A damaged power cord can cause fires or electrical shocks. Check
AND ALL PERIPHERAL DEVICES
frequently that it is in good condition. If it becomes necessary to
SHOULD BE PLACED OUTSIDE
replace the power cord originally supplied with the instrument,
THE PATIENT AREA
contact your supplier.
Do not perform any repairs or maintenance work on the
instrument or the electrical system beyond what is explained in
this manual.
Do not use the instrument near water and be careful not to spill
liquids on any part of it. Avoid damp and dusty locations and
locations subject to brusque changes in temperature and humidity.
Disconnect the instrument from the main power supply before
cleaning and/or disinfecting.
The equipment neither generates nor receives electromagnetic
interference when used in proximity to other devices; no
preventive or corrective measures need therefore be taken in this
regard.
No precautions are required in case of change in the device’s
performance
In the standard configuration supplied by Manufacturer,
the system includes components that do not classify as
medical electrical equipment (PC or portable computer,
etc.) besides the fundus camera as such. The resulting
system is in any case tested in accordance with EN
60601‐1 (3rd edition), in particular according to the
requirements described in chapter 16. Since the unit in
question can include other instruments, medical
electrical and not, Manufacturer is unable to test compliance of
The patient area is the volume defined
all possible configurations. as shown in the figure, within which
The configuration verified by Manufacturer is the one with the PC the patient may come into contact
outside of the patient area. (intentionally or unintentionally,
directly or through contact with the
Any other accessories (printer, scanner, etc.) connected to the
operators) with medical electrical and
analog or digital interfaces of the system must be certified in other devices making up the system
accordance with the standards listed below.
EN 60950 for ITE equipment (safety regulations for information technology equipment),
or
EN 60601‐1 for medical electrical devices.
The connected accessories should be placed outside of the patient area.
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The operator should make sure, once all the equipment has been assembled, that the
resulting medical electrical system complies with the prescriptions of EN 60601‐1 (exact
prescriptions are given in chapter 16 of the aforementioned standard)
Should the measured leakage current values be outside of permissible limits, further safety
measures as suggested by EN 60601‐1 (3rd edition) should be adopted. In this case the entire
system should be powered through an appropriate separate transformer or an insulating
transformer.
The transformer is absolutely indispensable when it is difficult to keep the computer and
other non‐medical electrical devices outside of the patient area.
ATTENTION!
Only those units bearing the Manufacturer trademark and the external power supply (AC/DC Adapter
MEAN WELL Mod. MES3OB‐3P1J) of the “CONTROL BOX” may be placed and used inside the patient
area.
The following parts of the system must be placed outside the patient area:
Computer (PC or portable), with relative accessories (monitor, keyboards, mouse, etc.),
Printers,
Other auxiliary units that do not classify as medical electrical equipment (power supplies /
battery chargers, modems, etc.).
If the system needs to be connected to a network (LAN / WAN) it is suggested to take whatever
precautions necessary to avoid the importing of hazardous voltages coming from remote devices, by
means of the connected cables. It might be necessary to use data transmission devices that ensure
‘GALVANIC ISOLATION’.
Manufacturer disclaims all liability for the safety of the patient and the operator for electrical
connections between computers and other external devices (peripherals) or LANs, not provided by
Manufacturer.
1.4 End‐of‐life disposal information
In accordance 2012/19/UE concerning reduction of use of dangerous substances in electrical and
electronic equipment and disposal of electrical and electronic waste.
The instrument you have purchased is made using particular materials and substances. It may also
contain substances having potentially dangerous effects on the environment and human health if
released into the environment by improper disposal.
To avoid releasing dangerous substances into the environment and in order to promote conservation
of natural resources, and should the user decide to dispose of an end‐of‐life instrument, the
Manufacturer will facilitate re‐use and recovery and recycling of the materials it contains.
Governments agencies have adopted measures obliging users, distributors, and manufacturers to
contribute to collection of waste electrical and electronic equipment (WEEE) and prescribes that such
equipment find re‐use or be recovered or recycled.
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When disposing of the instrument, remember that disposal is regulated by precise European and
national laws and regulations that prescribe the following:
‐ Do not dispose of the instrument as ordinary municipal waste. For separate collection
contact a company specialized in disposal of waste electrical and electronic equipment or
your local waste disposal agency for information.
‐ If a new instrument is purchased from the same Manufacturer to replace an end‐of‐life
instrument put on the market before 13 August 2005, of an equivalent type and performing
the same functions as the new device, the distributor or Manufacturer is required by law to
take back the end‐of‐life device.
‐ If the user intends to dispose of a used device put on the market after 13 August 2005, the
distributor or Manufacturer is required by law to take back the device.
‐ The Manufacturer is responsible for transporting, treating, and recovering and/or recycling
any used equipment collected and for all relevant expenses.
‐ Do not forget that dangerous substances present in waste electrical and electronic
equipment and/or improper use of same or parts of same can have potentially adverse
effects on the environment and human health. The instrument described in this manual
contains metal and plastic mechanical parts, electrical components, and electronic circuit
cards. The Manufacturer is at user’s complete disposition for any information requested
regarding the dangerous substances contained in the instrument and recovery and recycling
procedures and/or the possibility of re‐using the end‐of‐life instrument.
Current legislation provides severe sanctions in the case of failure to respect disposal laws and
regulations in force.
2 System Components
The principal units making up the system are the:
Fundus camera whole unit, designed and built by Manufacturer, is composed of:
1. Fundus Camera instrument
2. Personal Computer (as option)
3. Dedicated software
4. Chinrest with illuminated fixation point and USB attachment
Standard accessories
The system is supplied complete with the accessories listed below:
‐ two guards for the advancement guides
‐ one dust cover
‐ one set Allen wrenches
‐ one pack chin rest papers
‐ two fuses
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1) Instrument
2) Optical lens
3) Chin rest
4) Chin rest hand held
5) Chin rest support
6) Toothed guides Unit
control box
7) Guide guards
8) Joystick with
acquisition button
9) Toothed wheels
10) Base slide lock knob
11) USB3 cable
12) Personal computer
13) Focus adjustment
handle
14) LED illumination
15) USB3 Socket
16) Fixation point power
supply (USB)
17) USB socket
18) RETINA400 External
power supply
19) Power supply name 20
plate
20) Power supply switch
21) External power input
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2.1 ID PLATE
Data on the plate : Essilor International
147 rue de Paris
• Name & Address of the legal Manufacturer. 94227 Charenton le Pont ‐FRANCE
• Name of the equipment. PRODUCT : FUNDUS CAMERA
• Serial number. Ref : ESSILOR RETINA 400
• year of manufacturing INPUT1 : 5V dc 0.5A INPUT2 : 24V dc 2A
S/N : 0416101
CAUTION:
2016
Federal law restricts this
device to sale by or on
the order of a physician
21CFR 801.109
3 Routine maintenance
The system requires no particular routine maintenance.
Clean the external surfaces of the instrument with a cloth slightly dampened with water. Do not use
thinners or solvents.
Protection from Dust
When the instrument is not in use, protect it from dust by replacing it in the carrying case.
Periodically remove any dust that has accumulated on the instrument with a very soft cloth or a
hand‐operated pump.
Unscheduled maintenance (repairs, replacement of components, checking internal parts, etc.) is the
exclusive competence of the Manufacturer technical assistance service
Attention
On request, the Manufacturer will supply diagrams, components lists, and particular technical
instructions for maintenance and calibration use by authorized and previously‐trained personnel
ATTENTION!
Do not use solvents or thinners
ATTENTION!
In case of need for maintenance, contact the technical service authorized by Manufacturer
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4 Instructions for use
a) Enter the program dedicated software ; first instructions for the dedicated software are the
following:
b) After inserting the patient or the necessary new exam, the software will prepare for
acquisition;
c) Make the patient sit comfortably with chin on the chin rest and forehead against the relative
support;
d) Raise or lower the chin rest using the wheel available on the chin rest support, in order to
center the patient’s eye on the output channel (computer monitor);
e) Move the focus knob in the default position.
f) Move the unit so that this is in a position of about 5 cm from the eye
g) Tell the patient to fixate the fixation target;
h) Slowly advance the instrument towards the eye, using the monitor for maintaining alignment
and focus, until the retinal image appears;
i) Make micro‐adjustments with the joystick to maximize image quality in terms of
homogeneity and illumination and field of view;
j) Optionally adjust focus with the focus adjustment handle;
k) It is possible to acquire more than one image per exam;
l) The images will be shown immediately afterwards on the main gallery.
The examination at this point is to be considered complete.
For more detailed information on dedicated software, we refer to the User manual of the software
ATTENTION!
Do not turn of the PC, nor disconnect the connection cable between PC and instrument while the
instrument is used
ATTENTION!
To turn of the system it is sufficient to follow standard procedures for exiting a software program and
turn of the power supply for the PC
TO ISOLATE (and obtain a condition of absolute safety) YOU SHOULD UNPLUG THE COMPUTER’S POWER CORD
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5 Technical specifications
5MP
Working distance (mm) 20
Image resolution 2448 x 2051
Power Supply Specific external power supply
(instrument) 24V dc 2A and USB3 5vdc 0.5A
Power Supply PC See Computer data plate
Weight (kg) ca. 10
Dimensions (mm) (H x L x D) 300 x 400 x 410
Shelf size (mm) 380 x 500
Classification according to safety standard EN60601‐1 (3rd ed.)
Class of protection against direct and class II
indirect contact
Applied Parts Type B
Compliance level for protection against Common devices (shell not
humidity protected) IP20
Method of sterilization or disinfection Disinfectable devices
Compliance level for protection in the No protection
presence of inflammable anesthetics
Use conditions Continuous service
Classification according to standard ISO 10940
Center of the field ≥ 60 line pairs/ mm
Midfield (r/2) ≥ 40 line pairs/ mm
Periphery of the field (r) ≥ 25 line pairs/ mm
Pixel pitch 6 μm
Field of view 50 ˚ x 42˚
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6 Installation
The USB3 cable is removable. You can access the connector the cable
by removing the cover located on the front of the instrument.
Retina400 Connection on computer with USB3
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This Device is compliant with marking. Date of first marking: March 2016
Essilor Instruments USA
8600 W. Catalpa Avenue, Suite 703
Chicago, IL 60656
Phone: 855.393.4647
Email: info@[Link]
[Link]
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