Topcon CC-100 User Manual

QUICK MANUAL
LCD Computerized Chart
CC-100 Series
REV. 10 2012
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 medical@topcon.eu
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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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PRECAUTIONS
Trade mark
CE
93-42 EC Directive Classification
Class I IEC 601-1 Classification
Class I, type B
Power Supply
AC 110-120 V or 220-240V -- 50-60 Hz
Power Absorption
120VA
Fuses
220-240 V: 20x5mm 2.5A Antisurge
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 :
Electrical Specifications:
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 Cispr 11
Group 1
The CC-100 SERIE 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 Emission Cispr 11
Class B
The CC-100 SERIE device is suitable for use in all establishments, except for domestic 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 IEC 61000-3-2
Class A Compliant
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
Voltage Fluctuation/flicker Emission
IEC 61000-3-3
Compliant
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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
EN 60601-1-2
Conformity Level
Electromagnetic
enviroment guide
Electrostatic Discharge (ESD) EN 61000-4-2
8kV air 6kV contact
8kV air 6kV contact
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical Fast Transient/Burst EN 601000-4-4
±2 kV high voltage
power line
±2 kV high voltage
power line
Mains power quality should be that of a typical commercial or hospital environment.
Surge EN 61000-4-5
Differential mode: 1 kV Common mode: 2kV
Differential mode: 1 kV Common mode: 2kV
Mains power quality 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 of UT)
for 0,5 cycle
40% UT (>60% dip of UT)
for 5 cycle
70% UT (>30% dip of UT)
for 25 cycle
<5% UT (>95% dip of UT)
for 5 seconds
<5% UT (>95% dip of UT)
for 0,5 cycle
40% UT (>60% dip of UT)
for 5 cycle
70% UT (>30% dip of UT)
for 25 cycle
<5% UT (>95% dip of UT)
for 5 seconds
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 be powered from an uninterruptible power supply or a battery.
Magnetic field at power frequency
EN 61000-4-8
3 A /m
3 A /m
Magnetic power frequency fields 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
EN 60601-1-2
Conformity Level
Electromagnetic enviroment
guide
Conducted RF EN 61000-4-6
3 Veff from 150kHz to 80MHz
3 Veff from 150kHz to 80MHz
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from that equation 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)
Radiated RF EN 61000-4-3
3 V/m from 80MHz to
2.5GHz
3 V/m from 80MHz to
2.5GHz
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 nominal power of the transmitter (W)
Separation distance at the transmitter frequency (m)
from 150kHz to 80MHz
D= 1,2 x P
from 80MHz to 800MHz
D= 1,2 x P
from 800MHz to 2GHz
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
I/R Sensor
Photo Sensor
Maddox Led
Test Area
Wall hook
Wallmounting screw holes
AC-3 pin
Power cable
MAIN BODY COMPONENTS
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CC-100 SERIES STANDARD ACCESSORIES
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Remote Control
(only for CC-100 Series instruments)
CC-Series Remote Control Batteries
(AAA Type)
CC-SERIES OPTIONAL ACCESSESORIES
REMOTE CONTROL
CC-100 WALL MOUNTING
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PREPARATIONS
Without WALL MOUNTING
With WALL MOUNTING
WARNING: use appropriate screws and plugs to fix the unit to the wall.
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