Essilor Instruments CS POLA 600 User Manual

www.essilor-instruments.com
User manual

CONTENTS

I. INTRODUCTION 5
1. Important 7
2. Outline of product 7
3. Classification 7
4. Certification 8
II. SAFETY INFORMATION 9
1. Introduction 10
2. Indications for use 10
3. Safety symbols 11
4. Environmental factors 12
5. Symbols marked on the instrument's packaging 14
6. Safety precautions 14
7. Electromagnetic emission 16
8. Electromagnetic immunity 17
III. FEATURES 19
IV. NOTES FOR USING THE INSTRUMENT 21
V. CONFIGURATIONS 23
VI. INSTALLATION 27
1. Instruction for wall mounting 28
2. Viewing distance (LCD display position) 28
3. Feature set 29
a. Feature set mode menu 29 b. Feature set mode setting method 29 c. Feature set mode disable 30 d. Function set overview 31
VII. TEST METHOD 39
1. How to use additional function 44
VIII. REMOTE CONTROL FUNCTION 45
1. General function 46
2. Slide function 47
IX. HOW TO RECHARGE A REMOTE CONTROL 49
X. UPGRADING A CSPOLA600 SYSTEM 51
XI. MAINTENANCE OF UNIT 53
XII. TROUBLESHOOTING GUIDE 55
XIII. ENVIRONMENTAL CONDITIONS 57
XIV. SPECIFICATIONS 59
XV. COMPONENT LIST 61
1. Standard accessories 62
2. Optional accessories 62
XVI. SERVICE INFORMATION 63
1. Repair 64
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.
Il manuale utente completo è disponibile su uno spazio Web. Per accedervi, scansionare il
codice QR seguente mediante un'applicazione dedicata.
O manual do utilizador completo está disponível num espaço web. Para aceder, queira
digitalizar o QR code seguinte com a ajuda de uma aplicação dedicada.
操作手册全文可在一个网络空间内查询。如要访问该空间,请使用一个专门的应用软件扫描 QR
码。
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1. IMPORTANT

This product may malfunction if exposed to electromagnetic interference generated by cell phones,
transceivers, radio-controlled toys, etc. Be sure to avoid bringing such items into close contact with the
product.
The information in this publication has been carefully checked and is believed to be entirely accurate at the
time of publication.
The manufacturer assumes no liability, however, for possible errors or omissions, or for any consequences
resulting from the use of the information contained herein.
The manufacturer reserves the right to make changes to its products or product specifications at any time
and without prior notice, and is not required to update this documentation to reflect such changes.
The CSPOLA600C includes the Circular Polarization technology, which provides optimal binocular
assessment.
These instructions describe how to use the CSPOLA600 correctly. In order to simplify the reading of the user,
we will use the term CSPOLA600.

2. OUTLINE OF PRODUCT

CSPOLA600 is an automatic visual chart system, stand-alone type, which displays broad range of charts,
based on LCD panel, including Red /Green for the eye optometry.
The chart rotation for CSPOLA600 can be performed by either wired or wireless remote control or by external
devices by control box of digital phoropter.
Unlike existing chart projector, CSPOLA600 is able to provide wider range of charts (more than 100 kinds of
general and special charts) on LCD panel and the product can be adjusted at the level of the patients for
precise examination.
This equipment is intended for use by medical doctors, orthotists, and optometrists.

3. CLASSIFICATION

Classification of equipment: class I
Applied part of equipment: no applied part
Protection against electric shock: class I
Protection against harmful ingress of water: ordinary (IPX0)
Method of sterilization: not applicable
Stability of use in an oxygen rich environment: not suitable
Mode of operation: continuous operation
The device is compliant with marking.
Expected useful life: 7 years
Date of first marking: 2013
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4. CERTIFICATION

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II. SAFETY INFORMATION

1. INTRODUCTION

Safety is everyone's responsibility. The safe use of this equipment is largely dependent upon the installer,
user, operator, and maintainer. It is imperative that personnel study and become familiar with this entire
manual before attempting to install, use, clean, service or adjust this equipment and any associated
accessories. It is paramount that the instructions contained in this manual are fully understood and followed
to enhance safety to the patient and the user/operator.
It is for this reason that the following safety notices have been placed appropriately within the text of this
manual to highlight safety related information or information requiring special emphasis. All users, operators,
and maintainers must be familiar with and pay particular attention to all Warnings and Cautions incorporated
herein.
Accessory equipment connected to the analog and digital interfaces must be certificated according to the
respective IEC standards (e.g. IEC 60950-1 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations shall comply with the system standard EN 60601-1:2006, Clause
16.
Everybody who connects additional equipment to the signal input part or signal output part configures a
medical system, and is therefore responsible that the system complies with the requirements of the system
standard IEC 60601-1:2005, Clause 16. If in doubt, consult the technical service department or your local
representative.
“Warning” indicates the presence of a hazard that could result in severe personal
injury, death or substantial property damage if ignored.
“Note” describes information for the installation, operation, or maintenance of which is
important but hazard related if ignored.
“Caution” indicates the presence of a hazard that could result in minor injury, or
property damaged if ignored.

2. INDICATIONS FOR USE

The indications for use include the visual acuity for determining patient objective refraction.
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3. SAFETY SYMBOLS

The International Electro-technical Commission (IEC) has established a set of symbols for electronic medical
equipment which classify a connection or warn of any potential hazards.
I O I and O on power switch represent ON and OFF respectively.
This symbol identifies a safety note. Ensure that you understand the function of this control
before using it. The control's function is described in the appropriate user's or service manual.
Alternating current.
Direct current.
Identifies the point where the system's earth safety cable is attached to the chassis.
The protective earth cable is connected to conductive parts of Class I equipment for safety
purposes.
Indicates the medical device manufacturer.
Manufactured in xxxx (year).
This device is compliant with CE marking (Directive 93/42/CE).
Follow operating instructions.
Disposal of your old appliance
When this crossed-out wheeled bin symbol is attached to a product it means the
product is covered by the European Directive 2012/19/EU.
All electrical and electronic products should be disposed of separately from the
municipal waste stream via designated collection facilities appointed by the government or the local authorities.
The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.
For more detailed information about disposal of your old appliance, please contact your
city office, waste disposal service or the shop where you purchased the product.
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4. ENVIRONMENTAL FACTORS

Avoid the following environments for operation or storage.
Where the equipment is exposed to water vapor.
Don't operate an equipment with a wet hand.
Where the equipment is exposed to direct sunlight.
Where the temperature changes extremely.
Normal operating temperature range is from 10°C to 40°C, humidity is from 30% to 75%.
Where it is near the heat equipment.
Where the humidity is extremely high or there is a ventilation problem.
Where the equipment is subject to excessive shocks or vibrations.
Where equipment is exposed to chemical material or explosive gas.
Be careful not to be inserted dust, especially, metal.
Don't disassemble the product or open. We aren't responsible for it for nothing.
Be careful not to close the fan located on the lateral or back side of the equipment.
Don't plug the AC power cord into the outlet before the connection between devices of the
equipment is completed.
This can generate the defect.
Pull out the power cord with holding the plug, not the cord.
To avoid the risk of electric shock, this equipment must only be connected to supply mains
with protective earth.
CSPOLA600 shall be connected to the separate power supply as supplied by ESSILOR with
adapter technology Co., Ltd, type BPM060S12FXX Identified.
Do not position the equipment to make it difficult to operate the disconnection device.
(Appliance coupler or separable plug).
Ahead of going into the discard, ask way to do it or consult with selling agency.
This device incorporates a lithium battery (BAT1) on the main board and a li-ion battery
(BAT2) in the remote control, incorrect replacement of which would result in an unacceptable
RISK. Therefore, replacement by inadequately trained personnel could result in a HAZARD
(such as excessive temperatures, fire or explosion).
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Do not placed the multiple socket-outlet for CSPOLA600 system on the floor in order to
prevent liquid penetration and damage to the product.
CSPOLA600 system shall not be connected with additional multiple socket-outlets or extension
cords in addition to a designated single multiple socket-outlet.
Maximum permissible load of each socket-outlet used for the CSPOLA600 system, shall not be
less than 60VA.
Do not connect the device which is not a supplement of CSPOLA600 with the multiple socket-
outlet of CSPOLA600.
Multiple socket-outlet should be a grounding-type and complied with IEC 60884-1.
Do not use the same system in an overlapping or adjacent area with other equipment, and if
adjacent or overlapping use is required, be sure to monitor the equipment or system to ensure
that it is functioning properly in the array in which it will be used.
View from A-A (male plug connected)
Connection of the plug shall be possible only by
using the tool.
1: Male plug ME equipment
2: Cover
3: Spacer
4: Plate fixed on MSO
5: MSO
Avoid places where the ambient temperature falls below 10° or exceeds 40° for normal operation, or below
-10°C or exceeds 55°C (14°C-131°C) for transportation and storage.
Humidity should be maintained between 30 and 85% (Atmospheric pressure : 70 to 106kPa) for normal
operation, or between 10 and 95% (Atmospheric pressure : 50 to 106kPa) for transportation and storage.
Avoid environments where the equipment is exposed to excessive shocks or vibrations.
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5. SYMBOLS MARKED ON THE INSTRUMENT'S PACKAGING

Keep away from rain
Transport package shall be kept away from rain.
Minimum/Maximum temperature
Indicates the temperature limits to which the medical device can be safely exposed.
Minimum/Maximum humidity
Indicates the hygrometry limits to which the medical device can be safely exposed.
Minimum/Maximum atmospheric pressure
Indicates the air pressure limits to which the medical device can be safely exposed.
Fragile
Contents of the transport package are fragile therefore it shall be handled with care.
This way up
Indicates correct upright position of the transport package.
Use no hand hooks
Indicates correct upright position of the transport package.
Stacking limit by number

6. SAFETY PRECAUTIONS

This equipment has been developed and tested in accordance with safety standards as well as national and
international standards. This guarantees a very high degree of safety for this device.
The legislator expects us to inform the user expressively about the safety aspects in dealing with the device.
The correct handling of this equipment is imperative for its safe operation. Therefore, please read carefully
all instructions before switching ON this device. For more detailed information, please contact our Customer
Service Department or one of our authorized representatives.
1. This equipment must not be used: (a) in areas where there is a risk of explosion and, (b) in the presence of flammable, explosive, or volatile solvents such as alcohol, benzene or similar chemicals.
2. Do not put or use this device in humid rooms. Humidity should be maintained at between 30 and 75% for normal operation. Do not expose the device to water splashes, dripping water, or sprayed water. Do not place containers containing fluids, liquids, or gases on top of any electrical equipment or devices.
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CSPOLA600 - Polarized visual chart system > V5 - 03-2018
3. The equipment must be operated only by, or under the direct supervision of a properly trained and qualified person.
4. Modifications to this equipment may only be carried out by the manufacturer's service technicians or other authorized persons.
5. Customer maintenance of this equipment may only be performed as stated in the user's manual and service manual. Any additional maintenance may only be performed by the manufacturer's service technicians or other authorized persons.
6. The manufacturer is only responsible for any effects on safety, reliability, and performance of this equipment on condition that the following requirements have been fulfilled: (1) the electrical installation in the respective room is consistent with the specifications stated in this manual and, (2) this equipment is used, operated, and maintained according to the instructions given in this manual and the service manual.
7. The manufacturer is not liable for damage caused by unauthorized tampering with the device(s). Such tampering will forfeit any rights to claim under warranty.
8. Interconnected equipment to this equipment shall be complied with the applicable international standards, e.g. IEC/EN 60950-1 for I.T equipment.
9. Only persons who have undergone proper training and instructions are authorized to install, use, operate, and maintain this equipment.
10.Keep the user's and service manuals in a place that can be accessed any time by the persons operating and maintaining the equipment.
11.Do not force cable connections. If a cable does not connect easily, be sure that the connector (plug) is appropriate for the receptacle (socket). If you cause any damage to a cable connector(s) or receptacle(s), the damage must be repaired by an authorized service technician.
12.Please do not pull on any of the cables. Always hold on to the plug when disconnecting cables.
13.This equipment may be used for the international application.
14.Before every operation, visually check the equipment for exterior mechanical damage and to ensure that it is operating properly.
15.Do not cover any of ventilation grids or slits.
16.Immediately turn OFF and unplug any equipment that gives off smoke, sparks, strange noises or odours.
17.Use only accessories (including power supply) provided by the manufacturer.
18.No contraindication.
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7. ELECTROMAGNETIC EMISSION

This equipment complies with IEC60601-1-2 EMC standards for medical devices. This equipment requires
special precautions concerning EMC and must be supplied to the service in accordance with the EMC
information provided in the installation and operating instructions.
Unspecified accessories, transformer milled cables may cause damage to the machine or system, or reduce
its durability.
The manufacturer is not responsible for any interference caused by the use of non-recommended connecting
cables or by unauthorized changes or modifications to the equipment. Unauthorized changes or modifications
to the equipment could void the user's authority to operate the equipment. All cables to peripheral devices
must be properly shielded and grounded except for technically prohibited cables.
If properly shielded and ungrounded cables are used, the equipment may cause radio frequency
interference.
Do not use wireless devices such as wireless phones near this system.
Even if the equipment complies with EMC standards, it may cause malfunction due to electromagnetic
interference when used close to the system.
If you notice interference (EMC) from other equipment, please move it to another location.
Do not use the device or system in an overlapping or adjacent area with other equipment. If adjacent or
overlapping use is required, the equipment or system should be monitored to ensure normal operation in the
array in which it will be used.
The Electromagnetic Compatibility Directive sets the essential requirements for electrical and electronic
equipment that may disturb or even be disturbed by other equipment. CSPOLA600 complies with these
requirements as tabled below. Follow the guidance on the tables for use of the device in the electromagnetic
environment.
Guidance and manufacturer's declaration – electromagnetic emission
CSPOLA600 is intended for use in the electromagnetic environment specified below. The customer or the user
of CSPOLA600 should assure that they are used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF emission – CISPR 11 Group 1
CSPOLA600 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 A
CSPOLA600 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 emission
IEC 61000-3-2
Class A
Voltage fluctuation/flicker emission
IEC 61000-3-3
Complies
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8. ELECTROMAGNETIC IMMUNITY

Guidance and manufacturer's declaration – electromagnetic immunity
CSPOLA600 is intended for use in the electromagnetic environment specified below. The customer or the
user of CSPOLA600 should assure that they are used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
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 IEC
61000-4-4
±2 kV for power
supply lines
±1 kV for I/O lines
±2 kV for power
supply lines
±1 kV for I/O lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Voltage dips, short
interruptions and voltage
variations on power
supply input lines IEC
61000-4-11
<5 % U
T
(>95 % dip in UT)
for 0.5 cycle
40 % U
T
(60 % dip in UT) for
5 cycles
70 % U
T
(30 % dip in UT) for
25 cycles
<5 % U
T
(>95 % dip in UT)
for 5 s
<5 % U
T
(>95 % dip in UT) for
0.5 cycle
40 % U
T
(60 % dip in UT) for
5 cycles
70 % U
T
(30 % dip in UT ) for
25 cycles
<5 % U
T
(>95 % dip in UT) for
5 s
Mains power quality should be that of a
typical commercial or hospital
environment.
If the user of the CSPOLA600 requires
continued operation during power mains
interruptions, it is recommended that the
CSPOLA600 be powered from an
uninterruptible power ssupply or battery.
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.
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Guidance and manufacturer's declaration – electromagnetic immunity
The equipment CSPOLA600 is intended for use in the electromagnetic environment specified below. The
customer of the user of the CSPOLA600 should assure that it is used in such an environment.
Immunity test IEC 60601
Test level
Compliance level Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4- 6
Radiated RF
IEC 61000-4- 3
3 Vrms
150KHz to 80MHz
3V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communication
equipment should not be used close to
any part of the CSPOLA600, including
cables. Recommended separation
distance.
d=1,2*√(P)
d=1,2*√(P) 80 MHz to 800 MHz
d=2,3*√(P) 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 metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the
compliance level in each frequency range
b
.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note 1: at 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
CSPOLA600 is used exceeds the applicable RF compliance level above, CSPOLA600 should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating CSPOLA600.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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III. FEATURES

Red / Green reverse
CSPOLA600 system enables a user to reverse all kinds of Red/Green
chart by using Black & White reverse button on the remote control.
Animation function
CSPOLA600 system has an animation function for making a child
concentrated on the chart during the test and it easy to examine.
Contrast adjustment
CSPOLA600:
can decrease the contrast level in order to examine eye-sight
under low contrast condition.
enables a user to select contrast sensitivity (75%, 50%, 40%,
30%, 20%, 10%, 7.5%, 5%, 3%, 1.5%) on a screen and also each strength of the contrast sensitivity can be shown on the screen of remote control that is used during a vision test with a cataract surgery patient by adjusting optotype contrast sensitivity.
Black & White reverse
CSPOLA600 system enables a user to test conveniently by using Black &
White function which Lasik & Cataract patients can recognize in Bright &
Dark places.
Random function
Random function of CSPOLA600 system is designed to stop a visual test
error, when an examinee memorizes specific test types and directions. A
user can test conveniently by freely changing " Numbers, English,
Korean, Landolt, Snellen, Children".
Some charts such as Landolt, Number can be rotated by remote control.
Red / Green filter for color depth
adjustment
CSPOLA600 system enables a user to adjust to Red/Green filter
concentration from the 0 to the 31 steps. It applies to all kinds of R/G
chart.
Mirror function
The mirror function is added in CSPOLA600 system to let it installed at
less than 1.5m of narrow space and a user can easily select the function
at his convenience.
Clock dial rotating
7 kinds of clock dials are rotating step by step by using "Up & Down"
button on the remote control. It also reverses the Black & White by using
the "Black & White" reverse button on the remote control.
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