Essilor CORNEA 550 User Manual

User manual

CONTENTS

I. INTRODUCTION 5

1. General warnings 7

2. Symbols marked on the instrument 8

a. Symbols marked on the instrument's packaging 8

3. Intended use and operating procedures 9

a. Classification 10
b. Environmental conditions 11
c. Warranty 11

4. Safety precautions 12

5. Disposal at the end of life 13

II. SUPPLY PACKAGE 15

1. Parts identification 17

III. ROUTINE MAINTENANCE 19

IV. USAGE 21

V. TECHNICAL FEATURES 25

VI. GUIDANCE AND MANUFACTURER'S DECLARATION 27

1. Electromagnetic emission 28

2. Electromagnetic immunity 28

VII. APPENDIX 31

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.

Die vollständige Bedienungsanleitung ist auf einem Speicherplatz verfügbar: Für den Zugriff
darauf scannen Sie bitte untenstehenden QR-Code mittels einer dafür vorgesehenen
Anwendung.

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.

De volledige gebruikershandleiding is beschikbaar op een website. U kunt de handleiding
bereiken door de QR-code hiernaast te scannen met een geschikte applicatie.

Den komplette brukerhåndboken er tilgjengelig på et webområde. For å få tilgang, må du
skanne QR-koden nedenfor ved hjelp av en dedikert applikasjon.

O manual do usuário completo está disponível na área web do cliente. Para acessar, scanear o
código QR abaixo usando a respetiva aplicação.

1. GENERAL WARNINGS

These instructions describe how to use the CORNEA550 and CORNEA550E Corneal Topographic Systems
correctly. Only the marking and aesthetic change between these two products. Following the manual speak
to simplify CORNEA550.

Warning

Please carefully read this manual before using the device.

Our products are manufactured with maximum focus on 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.

The original text of this manual is in Italian.

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USER MANUAL> I. INTRODUCTION

2. SYMBOLS MARKED ON THE INSTRUMENT

WARNING

Symbol to point out attention on further information written in the instruction for use of
the device

Applied parts classified as Type B in accordance with EN 60601 1 standard‐

Refer to operation manual

It means that, for safety reasons, you need to consult the instruction manual before using
the device

Fuse

"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

Date of manufacturing

Manufacturer

Class II device

a. Symbols marked on the instrument's packaging

Indicates a medical device that needs to be protected from moisture

Indicates the temperature limits to which the medical device can be safely exposed

Indicates the hygrometry limits to which the medical device can be safely exposed

Indicates the air pressure limits to which the medical device can be safely exposed

Fragile

Handle with care

This side up – carton box orientation

Do not use hook for handling

Stacking limit

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3. INTENDED USE AND OPERATING PROCEDURES

The Corneal Topographer CORNEA550 is an electro medical system for the detection, capturing and digital
processing of an image of the cornea, for ophthalmologic diagnosis by eye specialists.

This system is the result of a long research carried out by recognized professionals to bring new technology,
quality and design together to the highest level. An absolute innovation in the field of topography, this
device allows "live" shooting on the computer monitor. Thanks to the electronic control of operating functions
and the broad operation distance (compared to other devices of the same type), this device eliminates image
decentralisation and focusing errors, ensuring measurement accuracy and repeatability. In addition, the
reduced brightness of placido's rings makes the exam comfortable for the patient thus guaranteeing ample
pupil size.

The video keratoscope is composed of:

• Placido's disk with 24 rings

• High-resolution colour video camera (1024x960 pixel)

• Management and control software including cornea measurement (AnaEyes)

The software allows the following:

Corneal topography module

• Assisted manual acquisition

• Advanced ring editing system allowing editing edge position to guarantee proper reconstruction also

on particularly distorted surfaces

• Available maps:
◦ Sagittal curvature map
◦ Tangential curvature map
◦ Altimetry
◦ Refractive power
◦ Gaussian curvature map

• The software elaborates display pages and summaries to focus on different aspects of a patient's

diagnosis
These include:

◦ 4-map summary
◦ Single map display page
◦ Keratoconus summary
◦ Advanced altimetry and Zernike's altimetric examination
◦ Corneal wavefront examination including:

- Editable pupil corneal wavefront examination summary with map of the most common
aberrations

- Avisual quality summary with PSF, spot diagram, MTF and sight simulation for the wavefront
examined

• Autofit to find the best contact lens based on corneal altimetry, on a database with over 50,000

lenses and possibility to customize a lens on the cornea by keying in description parameters and
simulating the lens placing it in different locations or tilting it to simulate the blinking effect

• Instruments for follow-up monitoring such as:
◦ 2 or 3 element differential maps
◦ Comparison of up to 4 different maps

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USER MANUAL> I. INTRODUCTION

• A wide range of synthetic descriptors of corneal characteristics such as:
◦ Sim-K to simulate fixed ophthalmoscope measurements (for the anterior surface)
◦ Main corneal meridians in 3 mm, 5 mm and 7 mm areas
◦ The flattest and steepest hemi meridians in 3 mm, 5 mm and 7 mm areas
◦ Peripheral degrees
◦ Pupil decentralization, pupillary radius and size of the corneal diameter
◦ Keratorefractive indices calculated in the pupil area to evaluate patient's visual quality
◦ Keratoconus screening index for diagnosis and follow-up

Pupillometry module

A pupillometry module completely integrated with topography enables:

• Pupillometry with scotopic light to determine pupil maximum extension and optic zone diameters for

treatment settings

• Pupillometry with mesopic light (4 lux)

• Pupillometry with photopic light (50 lux)

• Dynamic pupillometry, starting with over 400 lux and switching off the light source so that the pupil

can dilate to its maximum extension

• Evaluation of pupil decentralization from the corneal vertex for each of the conditions previously

described and calculation of the pupil centre during dilation

• Apply the measurements previously listed to the calculation of the corneal wavefront and visualize the

pupil in different conditions on the topographic map

Videokeratoscopy module

• Examination of the tear film with white light

• Examination of the tear film with fluorescein

• Break up time measurement

• Examination of tear layers

• Examination of rigid contact lens' adaptation with fluorescein

a. Classification

Medical device classification

Device classification in accordance with the rules set out in Annex IX of Directive 93/42/EC and subsequent
amendments: Class I with measuring function.

This device is 0459 since march 2015. Its expected lifetime is 7 years.

Electromedical devices classification

• Type of protection against direct and indirect contact: Class I

• The only applied part is the headrest

• Applied parts: Type B.

• Degree of protection against humidity: common device (no protection against water seepage) IP20.

• Sterilization method: disinfectable device.

• Degree of protection when used with anaesthetics or flammable detergents: no protection.

• Conditions of use: continuous operation.

• Degree of electrical connection between the device and the patient: device with parts applied to the

patient.

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b. Environmental conditions

As long as the device is kept in its original packaging, it can be exposed to the following environmental
conditions without being damaged, and for a maximum period of 15 weeks during shipping and storage:

Operation

• Temperature: +10 to +35°C

• Humidity: 30 to 90%

• Atmospheric pressure: 800 to 1060 hPa

Storage

• Temperature: -10 to +55°C

• Humidity: 10 to 95%

• Atmospheric pressure: 700 to 1060 hPa

Transportation

• Temperature: -40 to +70°C

• Humidity: 10 to 95%

• Atmospheric pressure: 500 to 1060 hPa

Vibration

• Sinewave: 10Hz to 500Hz 0.5g

• Shock 30g. Time: 6ms

• Bump 10g. Time: 6ms

c. Warranty

The manufacturer is responsible for compliance with Directive 93/42/EC as amended by 2007/47/EE, its
performance, safety and reliability, and the CE marking.

Device lifetime: 7 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

• The electrical installation of the room in which the appliance is not in compliance with IEC 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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4. SAFETY PRECAUTIONS

• Do not touch the computer mains power cable with wet hands. Make sure the mains power cable is

not walked on or trapped under weights. Do not tie the mains power cable.

• The power source must have a differential circuit breaker (IΔn= 30 mA) and a thermal magnetic

circuit breaker (Vn=230V) to protect the device. The power socket must be close and easily
accessible.

• A damaged power cable can cause fire or electric shock. It must be checked frequently. If the

supplied computer power cable needs to be replaced, please contact the supplier.

• Do not attempt to carry out any technical intervention on the device or on the system unless specified

in this manual.

• NEver attempt to modify or disassemble the device yourself.

• Do not use the device in the proximity of water and avoid liquid spillage on any surface of the device.

Avoid humid or dusty places or places which are subject to rapid fluctuations in temperature and
humidity.

• Unplug the device from the power socket before cleaning and/or disinfecting.

• The device does not generate or receive electromagnetic interferences when operated near other

devices. No preventive or corrective action is necessary.

• No precautions are necessary in case of any changes affecting the device performance.

• In addition to the image capturing system, the device includes non electromedical appliances

(personal computer, monitor, etc.). The resulting system is in any case tested in accordance with EN
60601:1 standards. Since the unit in question can include other instruments, medical electrical or not,
manufacturer is unable to test compliance of all possible configurations.

• The configuration verified by manufacturer is the one with the personal computer outside of the

patient's area.

• Any peripheral device (printer, scanner, CD player, etc) connected to the analogical or digital interface

of the system must comply with the following standards:

◦ EN: 60950-1 for ITE equipment (safety standards for information technology equipment ) or ;
◦ EN 60601:1 for medical electrical equipment. The peripheral devices must be connected outside

of the patient's area.

• After connecting all the peripheral devices, the user is responsible for regularly verifying compliance

of the electromedical system with EN 60601:1 standards (the specific requirements are reported in
chapter 16 of the standards).

• Excessive light energy provided by infrared diodes can damage the patient's retina.

The device and all peripheral devices should be placed outside the patient area.

The patient area is the volume defined as shown in the figure, within which the patient may come into
contact (intentionally or unintentionally, directly or through contact with the operators) with medical
electrical and other devices making up the system.

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