Topcon CC-100 User Manual

QUICK MANUAL

LCD Computerized Chart

CC-100 Series

REV. 10 2012

NOTE

Selecting externally connected equipment

The CC-100 Series Computerized chart complies with European Medical Device Directive and bears the CE marking.

Before connecting a external device to the CC-100 Series product make sure that such external equipment is in compliance with EN 60950-1 and CE marking.

This manual is referred to device with 3.4.x software version.

Manufacturer

VISIA imaging S.r.l. Via C. E. Gadda, 15

52027 San Giovanni Valdarno (AR) Italy

Distributor

Topcon Europe Medical B.V. Essebaan 11

2908 LJ Capelle a/d IJssel The Netherlands www.topcon.eu [e-mail]

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INTENDED USE

Utilisation

The CC-100 Series device is a instrument for the analysis of visual acuity.

The CC-100 Series device is able to execute the principal and most important visual tests: acuity, binocular vision, contrast sensitivity, and more.

The entire display screen is capable to display standard visual acuity tests and dissociated tests too.

The instrument display is commanded through an infrared remote control or through a direct connection with Topcon automated phoropters.

In comparison to the classical chart projectors, the PC functions allows for greater flexibility and more advanced functions.

Users

Oculists, ophthalmologists, opticians, optometrists.

The device must be uses by qualified personal.

Type of Environment where it could be use in

Ambulatory, physicians studios, opticians shops.

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Class I

Class I, type B

PRECAUTIONS

This instrument is an electronic precision unit, so be sure to use and store it in a place controlled under normal living temperature, humidity and atmospheric pressure, and avoid direct exposure to sunlight.

To ensure right operation, install the instrument on the wall and check for a precise horizontal and vertical alignment. Also do not put anything on top of the instrument.

To ensure an optimal coverage of polarized tests, align the center of LCD with the line of sight of the patient. Wear the polarized or Red/Green lenses and select in CC-100 Series a dissociated test, check the horizontal and vertical alignment until the best coverage for each eye is reached.

Connect all cables properly before using.

Use the power at a rated voltage.

When not in use, switch off the power source and protect the unit from sunlight and dust.

For accurate functioning, keep the instrument clean and free of spots and dust.

Technical Specifications :

Trade mark CE

93-42 EC Directive

Classification

IEC 601-1 Classification

Electrical Specifications:

Power Supply	AC 110-120 V or 220-240V -- 50-60 Hz
Power Absorption	120VA
Fuses	220-240 V: 20x5mm 2.5A Antisurge

Electromagnetic Compatibility

This product conforms to the EMC standard (IEC 60601-1-2:2007).

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the accompanying documents.

Portable and mobile RF communications equipment can effect medical electrical equipment

The use of accessories and cables other than those supplied with the instrument, exception for cables sold by the manufacturer of the equipment as replacement parts, may result in increase emission or decrease immunity of the equipment or system.

The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

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EMC Table

Emission Guidance

The CC-100 SERIE is intended for use in the electromagnetic environment specified below. The costumer or the user of the CC-100 SERIE should assure that it is used in such an environment.

	Emission Test			Compliance			Electromagnetic enviroment guide
	RF Emission			Group 1			The CC-100 SERIE device uses RF energy only for
							its internal function. Therefore, its RF emissions
	Cispr 11						are very low and are not likely to cause any
							interference in nearby electronic equipment.
	RF Emission			Class B			The CC-100 SERIE device is suitable for use in all
							establishments, except for domestic
	Cispr 11						establishments and those directly connected to
							the public low-voltage power supply network that
							supplies buildings used to domestic purposes.
							It is possible to use the device 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 Emission			Class A			It is possible to use the device in all
							establishments, including domestic
	IEC 61000-3-2			Compliant			establishments and those directly connected to
							the public low-voltage power supply network that
							supplies buildings used for
							domestic purposes
	Voltage Fluctuation/flicker			Compliant
	Emission
	IEC 61000-3-3

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Immunity Guidance

The CC-100 SERIE device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

	Immunity Test			Test level			Conformity Level			Electromagnetic
				EN 60601-1-2						enviroment guide
	Electrostatic Discharge (ESD)			8kV air			8kV air			Floors should be wood,
	EN 61000-4-2			6kV contact			6kV contact			concrete or ceramic tile. If
										floors are covered with
										synthetic material, the
										relative humidity should be at
										least 30 %.
	Electrical Fast Transient/Burst			±2 kV high voltage			±2 kV high voltage			Mains power quality should
	EN 601000-4-4			power line			power line			be that of a typical
										commercial or hospital
										environment.
	Surge EN 61000-4-5			Differential mode:			Differential mode:
				1 kV			1 kV			Mains power quality should
				Common mode:			Common mode:			be that of a typical
										commercial or hospital
				2kV			2kV			environment.
	Voltage dips, short			<5% UT			<5% UT
	interruptions and voltage			(>95% dip of UT)			(>95% dip of UT)
	variations on power supply
				for 0,5 cycle			for 0,5 cycle
	input lines
										Mains power quality should
	EN 61000-4-11									be that of a typical
				40% UT			40% UT			commercial or hospital
				(>60% dip of UT)			(>60% dip of UT)			environment. If the user of
										the device requires continued
				for 5 cycle			for 5 cycle
										operation during power
										mains interruptions, it is
				70% UT			70% UT			recommended that the
										device be powered from an
				(>30% dip of UT)			(>30% dip of UT)			uninterruptible power supply
				for 25 cycle			for 25 cycle			or a battery.
				<5% UT			<5% UT
				(>95% dip of UT)			(>95% dip of UT)
				for 5 seconds			for 5 seconds
	Magnetic field at power			3 A /m			3 A /m			Magnetic power frequency
	frequency									fields
	EN 61000-4-8									should be that of a typical
										commercial or hospital
										environment.

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Immunity Radio Frequency Guidance

The CC-100 SERIE is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is use within those environmental conditions..

	Immunity Test			Test level			Conformity Level			Electromagnetic enviroment
				EN 60601-1-2						guide
	Conducted RF			3 Veff from 150kHz to			3 Veff from 150kHz to			Portable and mobile RF
										communications equipment should
	EN 61000-4-6			80MHz			80MHz
										be used no closer to any part of the
										device, including cables, than the
	Radiated RF			3 V/m from 80MHz to			3 V/m from 80MHz to			recommended separation distance
										calculated from that equation
	EN 61000-4-3			2.5GHz			2.5GHz
										applicable to the frequency of the
										transmitter.
										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)

The field intensity of the fixed RF transmitters, as checked in an electromagnetic investigation of the locus, should be less than the conformity level for each range of frequency. It is possible to have interference near devices marked with the symbol:

Recommended separation distances between portable and mobile RF communications equipment and the CC-100 XP device

CC-100 SERIE device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 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.

	Output maximum		Separation distance at the transmitter frequency (m)
	nominal power of
	the transmitter (W)		from 150kHz to 80MHz	from 80MHz to 800MHz	from 800MHz to 2GHz
			D= 1,2 x P	D= 1,2 x P	D= 2,3 x P
0,01			0,12	0,12	0,23
0,1			0,38	0,38	0,73
1			1,2	1,2	2,3
10			3,8	3,8	7,3
100			12	12	23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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.

Notes:

(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.

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Symbol Table:

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WARNING INDICATIONS AND POSITIONS

For safety purposes, this equipment includes clearly labelled warnings.

Use the equipment following this warning instructions.

CAUTION

To avoid electrical shock, do not open the instrument. Refer all servicing to only qualified personnel.

WARNING

Electrical shock may cause burns or possible fire. Turn the main power switch OFF and UNPLUG the power cord before replacing fuses. Replace only with fuses of the correct rating.

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COMPONENTS

MAIN BODY COMPONENTS

I/R Sensor

Photo Sensor

Maddox Led

Test Area

Wall hook

Wallmounting screw holes

AC-3 pin

Power cable

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CC-100 SERIES STANDARD ACCESSORIES

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CC-SERIES OPTIONAL ACCESSESORIES

REMOTE CONTROL

	Remote Control	CC-Series Remote Control Batteries
		(AAA Type)
	(only for CC-100 Series instruments)

CC-100 WALL MOUNTING

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PREPARATIONS

WARNING: use appropriate screws and plugs to fix the unit to the wall.

Without WALL MOUNTING

With WALL MOUNTING

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