Topcon CA-200F Manual de usuario

INSTRUCTIONS FOR USE

CORNEAL ANALYSER

CA-200F CORNEAL ANALYSER

0051 REV. 7 2012

CA-200F Corneal Analyser - Rev. 7 16/01/2012

NOTES

Installation with external devices

The CA-200F corneal analyser complies with the CE marking requirements.

Before connecting an external device (computer, printer, display, keyboard, mouse, slit lamp), check that

these devices are in compliance with the EN 60950-1 standards and bear the CE marking.

If the CA-200F corneal analyser is installed in rooms for medical use, any connected personal computer and

printer must be powered by an insulated transformer in accordance with IEC 60601-1.

If the CA-200F corneal analyser is installed in rooms for medical use and is not connected to a computer,

there is no need to use an insulated transformer. If a printer is connected directly to the CA-200F corneal

analyser, it must be powered by an insulated transformer in accordance with IEC 60601-1.

In the event of an accident or near accident due to use of the instrument, please contact:

Manufacturer

VISIA imaging S.r.l.

Via C. E. Gadda, 15

52027 San Giovanni Valdarno (AR)

Italy

In the event of a fault or to request technical service, contact:

Distributor

TOPCON EUROPE MEDICAL B.V.

Essebaan 11

2908 LJ Cappelle A/D Ijseel

THE NETHERLANDS

WARNING

The CA-200F device must be used with the power supply provided in the package

and in any case only with an EXM 80 5118 power supply for medical use.

CA-200F Corneal Analyser - Rev. 7 16/01/2012

INTENDED USE

Use:

CA-200F is a corneal analyser with integrated pupillograph.

The instrument acquires images of the cornea and analyses its topography.

The software selects the image with the best focus out of a sequence of images.

In the image, the rings of the disc reflected by the illuminated cone are used to geometrically calculate the

topographic map of the cornea. From the topographic map data, a set of parameter indices are processed

for the measurements.

The main applications of the corneal analyser are the following:

Cornea measurements for diagnostic instruments

Cornea and pupil measurements for application of contact lenses

Fluorescence analysis for contact lens positioning

Pupil measurements for the determination of specific pathologies

Users:

Eye specialists, ophthalmologists, opticians, optometrists.

The instrument must be used by qualified persons.

Facilities:

Health centers, optician shops, eye hospitals and other eye-care related facilities.

CA-200F Corneal Analyser - Rev. 7 16/01/2012

INTRODUCTION

Thank you for purchasing the TOPCON CA-200F Corneal Analyser.

The intuitive and user-friendly software interface and the hardware, designed for patient comfort, make the

CA-200F one of the most popular corneal analysers on the market.

The instrument analyzes any type of corneal map: axial, instantaneous with 2D representation.

This instrument also allows you to simulate contact lenses and view the 3D map to analyze the wavefront

corneal aberrations.

Notes:

This manual describes the TOPCON CA-200F corneal analyser, including the functions, basic operations,

instrument cleaning, and instrument storage.

For best use of the instrument, carefully read the instructions provided.

Keep these instructions in a safe place.

CA-200F Corneal Analyser - Rev. 7 16/01/2012

PRECAUTIONS

This electronic instrument is a precision unit. Use and store it in a suitable place in normal temperature,

humidity and atmospheric pressure conditions and avoid exposure to direct sunlight.

To ensure proper functioning, install the instrument in a place not subject to vibrations.

Connect all the cables correctly before use.

Use the recommended mains voltage.

When the unit is not used, disconnect the power supply and protect it against the sun and dust.

In order to obtain accurate and reliable measurements, keep the measuring cone clean and dust-free.

This product is in compliance with the EMC standards (IEC 60601-1-2:2001).

-ELECTROMEDICAL DEVICES require particular precautions for electromagnetic compatibility and

must be installed and set up based on the EMC information provided in the accompanying

documents.

-Portable RF communication instruments may interfere with medical devices.

-Using accessories and cables different from those provided with the instrument, except for the

cables sold by the equipment manufacturer as spare parts, may result in increased emissions and

reduce the immunity of the device or system.

-The device must not be used in contact with other equipment.

If it is inevitable to use the device in contact with other instruments, check proper functioning in the

required configuration.

EMC table

Emission aspects

The CA-200F device is intended for use in the electromagnetic environment specified below. The

customer or the user of the device should ensure that it is used in the said environment.

Emission test

Compliance

Electromagnetic environment –guidance

RF emissions

CISPR 11

Group 1

The CA-200F device uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

RF emissions

CISPR 11

Class B

The CA-200F device is suitable for use in all establishments,

including domestic establishments and those directly connected to

the public low-voltage power supply network that supplies buildings

used for domestic purposes.

Harmonic emissions

IEC 61000-3:2

Class A

Compliant

The device can be used in all buildings, including domestic buildings

and those directly connected to the public low-voltage power supply

network, that supplies buildings used for domestic purposes.

Voltage fluctuations/

flicker emissions

IEC 61000-3:3

Compliant

CA-200F Corneal Analyser - Rev. 7 16/01/2012

Immunity aspects

The CA-200F device is intended for use in the electromagnetic environment specified below. The

customer or the user of the CA-200F device should assure that it is used in the said environment.

Immunity test

EN 60601-1-2

test level

Compliance level

Electromagnetic environment –

guidance

Electrostatic discharge

(ESD)

EN 61000-4-2

6kV contact

8kV air

6kV contact

8kV air

Floors should be made of wood,

concrete or ceramic tiles. If floors

are covered with synthetic

material, the relative humidity

should be at least 30%

Electrical fast transient/

burst

EN 61000-4-4

2kV for power

supply lines

2kV for

power supply lines

The quality of the power mains

should be that of a typical

commercial or hospital

environment.

Surge

EN 61000-4-5

1kV differential

mode

1kV differential mode

The quality of the power mains

should be that of a typical

commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input lines

EN 61000-4-11

< 5% UT

(>95% dip in UT)

for 0.5 cycle

40% U T

(60% dip in UT)

for 5 cycle

70% U T

(30% dip in UT)

for 25 cycle

< 5% U T

(>95% dip in UT)

for 5 seconds

< 5% U T

(>95% dip in UT)

for 0.5 cycle

40% U T

(60% dip in UT)

for 5 cycle

70% U T

(30% dip in UT)

for 25 cycle

< 5% U T

(>95% dip in UT)

for 5 seconds

The quality of the power mains

should be that of a typical

commercial or hospital

environment. If the user requires

continuous device operation

during power mains interruptions,

it is recommended that the device

be powered using an

uninterruptible power supply or a

battery.

Power frequency

magnetic field

EN 61000-4-8

3 A/m

Power frequency magnetic fields

should be at levels characteristic

of a typical location in a typical

commercial or hospital

environment.

CA-200F Corneal Analyser - Rev. 7 16/01/2012

Radio frequency immunity aspects

The CA-200F device is intended for use in the electromagnetic environment specified below. The

customer or the user of the CA-200F device should assure that it is used in the said environment.

Immunity test

EN 60601-1-2 test

level

Compliance level

Electromagnetic environment –

guidance

Conducted RF

EN 61000-4-6

3 V from 150kHz to

80MHz

3 V from 150kHz to

80MHz

Portable and mobile

RF communications equipment should not

be used in the vicinity of the device,

including its cables,

unless the recommended

separation distance

calculated from the

equation applicable to the frequency of the

transmitter is observed.

Recommended separation distance

d = 1.2 P from 150kHz to 80MHz

d = 1.2 P from 80 MHz to 800 MHz

d = 2.3 P from 800 MHz to 2.5 GHz

where P is the maximum output power rating of

the transmitter in watts (W) according to the

transmitter manufacturer

and d is the recommended separation distance

in meters

( m ).

Radiated RF

EN 61000-4-3

3 V from 80MHz to

2.5GHz

3 V from 80MHz to

2.5GHz

The fixed RF transmitter field strength, as determined by an electromagnetic site survey,

may be lower than the compliance level in relation to each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

Recommended separation distances between portable and mobile RF communications equipment and

the surgical Navigation device

The CA-200F device is intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of device can help prevent electromagnetic interference by maintaining a

minimum distance between portable and mobile RF communications equipment (transmitters) and the device as

recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

of transmitter (W)

Separation distance according to frequency of transmitter (m)

150kHz to 80MHz

d = 1.2 P

80MHz to 800MHz

d = 1.2 P

800MHz to 2GHz

d = 2.3 P

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters (m)

can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power

rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note:

(1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies

(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection

from structures, objects and people.

CA-200F Corneal Analyser - Rev. 7 16/01/2012

Symbols

IEC

publications

Description

IEC 60417-5840

CLASS II DEVICE IN ACCORDANCE WITH 60601-1

APPLIED PART TYPE B

IEC 60417-5172

INSULATION CLASS II DEVICE (DOUBLE INSULATION)

PRODUCT IN ACCORDANCE WITH DIRECTIVE 93/42/EEC

IEC 60417-5032

ALTERNATING CURRENT

ISO 7000-0434A

WARNING, CONSULT THE ATTACHED DOCUMENTATION

ISO 7000-1641

OPERATING INSTRUCTIONS

CLASS 1 LED PRODUCT IN ACCORDANCE WITH EN 60825-1

This symbol applies solely to EU member states.

With the aim of preventing potential negative consequences for the environment and

possibly human health, this instrument must be disposed of (i) in compliance with the

WEEE (Waste Electrical and Electronic Equipment) Directive for member states of the

EU, or (ii) in compliance with the local recycling regulations and laws for all other

countries.

CA-200F Corneal Analyser - Rev. 7 16/01/2012

WARNINGS FOR SAFE USE

In order to safely use the instrument and prevent risks to the operator and other persons as well as damage

to the device, the instruction manual provides a description of the safety warning labels and plates on the

instrument body.

Carefully read the following PRECAUTIONS and SAFETY RULES as well as the manual and observe the

instructions contained therein.

WARNINGS

Improper use of the instrument ignoring this warning may result in death or serious injury.

Improper use of the instrument ignoring this warning may result in personal injury or physical damage.

CA-200F Corneal Analyser - Rev. 7 16/01/2012

USE AND MAINTENANCE

USE

As the CA-200F Corneal Analyser is an electronic instrument for medical purposes, it must be used by

expert and qualified staff.

MAINTENANCE

To ensure the safety and performance of the equipment, it is advisable not to perform operations different

from those indicated below. For detailed information, please follow the instructions.

Calibration check

For details see the paragraph “Calibration Check”in the MAINTENANCE section of this manual.

Measuring cone cleaning

For details see the paragraph “Instrument cleaning and maintenance”in the MAINTENANCE section of

this manual.

RESPONSIBILITY

The manufacturer is not responsible for damage caused by fire, earthquakes, actions by third parties and

other accidents, or negligence and abuse of the instrument by the user in unusual conditions.

The manufacturer is not in any way responsible for damages caused by the user or by unavailability of the

device, such as a loss of profits or suspension of business.

The manufacturer is not responsible for damages caused by use of the device for purposes different from

those described in this instruction manual.

The manufacturer is not responsible for the result of the diagnoses performed with this device.

WARRANTY CONDITIONS

The Warranty is valid subject to application of the above mentioned clauses and only on condition that the

instrument is strictly used for the purposes described in this manual. The warranty conditions applied are

those provided for by local legislation.

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