Topcon CC-100 User Manual

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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 medical@topcon.eu

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.

PRECAUTIONS

Trade mark

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.

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

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

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

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

Magnetic power frequency fields should be that of a typical commercial or hospital environment.

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

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

0,23

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 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.

Symbol Table:

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.

COMPONENTS

I/R Sensor

Photo Sensor

Maddox Led

Test Area

Wall hook

Wallmounting screw holes

AC-3 pin

Power cable

MAIN BODY COMPONENTS

CC-100 SERIES STANDARD ACCESSORIES

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

PREPARATIONS

Without WALL MOUNTING

With WALL MOUNTING

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

SWITCH BETWEEN LCD Chart Projector and CV-tablet

When using the new CC-100 Series device, we will find pre-installed two main charts software. The LCD Chart Projector and of course the CV-tablet.

To use one instead of the other follow the steps below directly on the CC-100:

1- First of all connect an external

mouse to the CC-100, now to exit the application click two times on the left button, if on the LCD Chart Projector, or just a click if on the CV-tablet

2- Click on the start button

3- Launch the CC Series and CV

tablet switcher

4- Choose the desired application

clicking on the proper button:

BASIC OPERATIONS

1 Infrared led 2 Mode selection 3 Visual Acuity selection 4 Mask and red-green filter functions 5 Random 6 Contrast 7 Inverted 8 Fixation point / Amsler’s grid,

Schober test / Worth test

9 Bichromatic vision tests and

Polarized stereo tests (CC-100XP) Bichromatic vision tests and RG

stereo tests (CC-100) 10 ETDRS 11 Astigmatism Tests (clock, grid, dots) 12 Contrast sensitivity test / SineWave

contrast sensitivity test 13 Pseudoisochromatic test 14 Fixation charts 15 Arrows navigational cursor direction 16 Menu (second function: exit from

special test) 17 Light (second function: no answer in

the special tests) 18 MKH sequence 19 Stereo Right / Left eye inversion

1 2 3

4 6 5 7 8

REMOTE CONTROL (CC-100 SERIES MODE )

VISUALIZATION OF A SPECIFIC SCREEN SHOT

Letters

Snellen E

Landolt C

Numbers

Drawings for Children

Select symbols

Select Visual Acuity levels

ETDRS

Only the first two buttons of section can be used.

Masking by line, column or single cell and red-green background

Vertical Mask

Horizontal Mask

Single Cell Mask

R/G Background

Casual chart generating (random function)

To deactivate the function press the button again.

Contrast modifying of “chart over background”

Pressing the arrow buttons on the remote control the type contrast change with step 0.1. To deactivate the function press the button again.

Inversion

OFF

If fixation led option is set to ON (see Menu section on this manual).

To deactivate the function press the button again.

Fixation point, Amsler’s grid, Worth test and Schober test

CC-100: Bichromatic monocular tests

CC-100XP: Polarized balance test (see Note 1)

NOTE 1 (for CC-100XP only)

The drawings are only exemplificative. Red parts are seen by the right eye, green parts are seen by the left eye. The charts are all black on white.

Dissociated tests

CC-100: Red/Green filter

CC-100XP: Left/Right circular polarization (see Note 1)

Unpolarized tests

SPECIAL TESTS

Choose Chart Type Choose Visual Acuity Level

Start Test

Contrast Sensitivity Test

(First press)

Use the arrow buttons for the test. The least difference of contrast distinguished from the patient is displayed on the screen.

Sinewave Contrast Sensitivity

Choose Test Map Map Settings

Start Test

(Second press)

Map patterns and settings

Enter into Map Settings sub menu to change options for selected Test Map.

Each Test Map has a pattern you can edit from Edit Map function.

Test Map

Contrast levels

Frequency levels

Map 1

5 4 Map 2

8 5 Map 3

Displayed image

Arrow button to

press

Use the arrow buttons for the test, the "none" key (17) must be pressed for no answer

A graph will be visualized. The area of normality is underlined in green.

Pseudoisochromatic Test

Test Procedure (ON/OFF) Sample plates (ON/OFF)

Start Test

Ask the patient to recognize three different symbols hidden between dots.

Testing without test procedure Use right arrow button to go to the next plate. Use left button to go to the previous plate.

Up and down arrow plate change the symbol inside the same plate.

Testing with test procedure Ask the patient to recognize the position of the symbol (not the symbol itself) inside the screen. Use the

diagonal arrow button to match patient's answers.

Symbol in upper left position

Symbol in upper right position

Symbol in bottom left position

Symbol in bottom right position

At the end of the test with test procedure a table will be presented.

FIXATION TARGETS

Use this menu item to refresh the group list, adding groups archived on USB.

…

Next image in sequence

Previous image in sequence

Images and movies are located into 4 different groups. If you use the USB archive too, also the groups stored in the USB pendrive are shown.

Images

Display images to use as fixation targets.

Use arrows to select image.

Movies

Play the movies.

Use arrows to manage movies.

Previous movie

Next movie

Replay / Go back

Continue / Go ahead

USB pen drive root ( \ )

images

various

group 2

1.jpg

2.jpg

.....

a.avi

b.avi

.....

movies

group 1

1.swf

2.swf

.....

How to configure the USB pen drive to archive additional images and/or movies

 Format USB pen drive in FAT32 file system format  In the device root, create a folder called “images”  Into the “images” folder, copy your image files (in JPG format) under some sub-folders (the name

can be set by the user)

 In the device root, create a folder called “movies”  Into the “movies” folder, copy your movie files (in SWF, AVI format) under some sub-folders (the

name can be set by the user) N.B.: inside each sub-folder, all the movies must be of the same format!

An example of how to configure an USB pen drive is shown below.

MKH SEQUENCE

Next chart in sequence

Previous chart in sequence

(see Note 1)

Use arrows to select chart.

Use R/L button to swap right and left eye.

LIGHT

Screen illumination.

General Settings

Language

Language selection.

Kids Chart Types (CC-100 Series / KB-50)

Chart A

Chart B1

Chart C

OFF

Distance

Distance patient-display.

Mirror

Progression

Decimal

LogMAR or ISO8596

Measurement Units

Notation for Visual Acuity: Decimal, Monoyer, Snellen (m), Snellen (Ft), or LogMAR.

Acuity Value Display

Possible settings: ON, ON/OFF, ON/OFF big fonts, OFF.

I/R Devices

Select a working mode for each of the 4 channels.

Serial Device

Connect the Topcon CV-5000 by serial connector. For the COM port baud rate, see the Technical Settings.

VA Background Regulation

Regulate the brightness of the background

Red Level Regulation

Set the red tone parameter of the screen to be used with the red-green filter.

Green Level Regulation

Sets the green tone parameter of the screen to be used with the red-green filter.

Light Sensor

Determine if the environment illumination is correct.

Fixation Led

Enable or disable the fixation led when using Maddox test.

Select Printer

Select the default printer.

Technical Settings

Access to the administrator area.

Technical Settings

Upgrade

To upgrade the CC-100 Series Device software you will receive a compressed zip file. It contains only 2 files:

 Upgrade.exe  a big file with extension .UPG; its name tells you the version of that upgrade (for example: CC-100

3.3.1.UPG or CC-100XP 3.3.1.UPG)

To upgrade the CC-100 Series Device software do the following things:

1. Unpack the zip file in a blank, FAT32 formatted, USB pen drive

2. Plug the pen drive in a USB port of the CC-100 Series Device

3. In the CC-100 Series Device go to Menu and select Technical Settings, and then Upgrade

 the message “Copying new files. Please wait...” appears for a moment  the message “Remove the USB pen drive. The system will now restart.” appears  the system reboots for the first time (this may take a while)

4. When the system boots up, the upgrade process will start automatically

5. At the end of the upgrade process, the system will reboot for the second time

6. Finally, after the boot, the upgrade is done, and the system is ready to use.

The upgrade procedure needs the system has to be rebooted two times, but the entire process is very easy from the user side. In addiction, the upgrade procedure integrates some checks to prevent the updating of wrong systems: so, only systems with hardware 2.0 can be updated, and only the same system type (CC-100 upgrade over a CC-100, and CC-100XP upgrade over a CC-100XP).

Screensaver

Screensaver settings.

Configure Network

Network settings. ONLY FOR SPECIFIED MODELS.

Serial COM port baud rate

Serial COM port baud rate setting.

Settings: Reset to Default

Reset to default settings.

Exit

It terminates the software.

CONFIGURE NETWORK

ONLY FOR SPECIFIED MODELS.

“Standalone” Mode

Use the device as stand-alone. No network use.

“Network” Mode

Use the device as part of a network (PC). The system configures the network automatically.

Server search (PC with communication software installed).

Server selection.

MAINTENANCE

Power supply voltage

Fuse’s type

Fuse’s value

220 – 240 V

20 x 5 mm

2.5 A 250 V antisurge

Fuse change of the CC-100 Series

Make sure that the power switch of the main body is off and the power cable is unplugged.

Fuse’s types

Battery change of the CC-100 Series remote control

Channel

Channel Switches

S1 = H

S2 = H

S1 = L

S2 = H

S1 = H

S2 = L

S1 = L

S2 = L

Channel switch position on the remote control

Channel switch

Remove the battery cover, insert new 1.5V batteries (type AA) and replace the cover.

Change of the channel setting of CC-100 Series remote control

Remove the battery cover from the back of the remote control.

Set the remote control channel following the table below:

Topcon CC-100 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual