CSO DELUXE2 User manual

FUTURE
COSTRUZIONE STRUMENTI OFTALMICI
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EN
INSTRUCTIONS FOR USE
Ophthalmic unit
DELUXE2 / DELUXE3
IFU318EN01.00 - 02/2022
COSTRUZIONE STRUMENTI OFTALMICI
phone: [phone] | fax: [phone]
[email protected] | www.csoitalia.it
Colour
Inside

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1INTRODUCTION......................................................................................... 3
1.1 SYMBOLS .......................................................................................................... 3
1.1.1 Device symbols ..................................................................................................... 4
1.2 GENERAL WARNINGS ........................................................................................... 5
1.3 NORMATIVE REFERENCES ..................................................................................... 6
1.3.1 Community directives ........................................................................................... 6
1.3.2 Technical standards.............................................................................................. 6
1.3.3 Quality management systems standards ............................................................. 6
1.4 WARRANTY ....................................................................................................... 6
1.5 MANUFACTURER IDENTIFICATION ........................................................................... 8
2SAFETY....................................................................................................... 9
2.1 SAFETY WARNINGS .............................................................................................. 9
2.2 DEVICE IDENTIFICATION...................................................................................... 11
2.2.1 Registration data in the Medical Devices Repertoire.......................................... 11
2.2.2 Device data plate................................................................................................ 11
2.3 INTENDED USE.................................................................................................. 12
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 13
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION......................................................... 14
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 14
2.7 DISPOSAL AT THE END OF THE USEFUL LIFE .............................................................. 15
2.8 MANUFACTURER DECLARATIONS .......................................................................... 17
2.8.1 Electromagnetic emissions ................................................................................. 17
3DEVICE DESCRIPTION .............................................................................. 18
3.1 SUPPLY DESCRIPTION ......................................................................................... 18
3.2 ACCESSORIES ON DEMAND .................................................................................. 21
3.3 KEYPADS ......................................................................................................... 22
3.3.1 Function of keypad buttons ................................................................................ 22
3.3.2 Function of the table keypad buttons ................................................................. 23
3.4 TECHNICAL DATA .............................................................................................. 24
3.5 BULK ............................................................................................................. 25
4DEVICE USE ............................................................................................. 27
4.1 HOW TO INSTALL THE OPHTHALMIC UNIT ................................................................ 27
4.2 HOW TO INSTALL STICKER PAD FOR PLACING THE DEVICE ON THE TABLE TOP ....................27
4.3 HOW TO PLACE THE CHIN REST ............................................................................. 29
4.3.1 Placing the chin rest on the support ................................................................... 29
4.4 HOW TO PLACE DEVICES ON THE TABLE TOP ............................................................. 31
4.5 HOW TO PLACE ELECTRIC CABLES .......................................................................... 32
4.6 HOW TO TURN ON THE OPHTHALMIC UNIT .............................................................. 33
4.7 HOW TO CONFIGURE THE DEVICES SETTINGS ............................................................ 33
4.8 HOW TO ADJUST THE CHAIR................................................................................. 33
4.9 HOW TO TURN ON THE LED SPOTLIGHT.................................................................. 33
4.10 HOW TO TURN ON THE DEVICES ON THE OPHTHALMIC UNIT......................................... 33

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4.11 HOW TO RESET THE CHAIR .................................................................................. 33
4.12 HOW TO PLACE THE TABLE TOP TO EXAMINE THE PATIENT........................................... 34
4.13 HOW TO TURN OFF THE DEVICE............................................................................ 34
5ORDINARY MAINTENANCE ......................................................................35
5.1 SAFETY WARNINGS ........................................................................................... 35
5.2 CLEANING ...................................................................................................... 35
5.3 NETWORK FUSES REPLACEMENT........................................................................... 36
5.4 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 37
5.5 TROUBLESHOOTING .......................................................................................... 38

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1INTRODUCTION
The device is the result of a long research period, conducted by
experts to give the product technical innovation, quality and design.
Ophthalmic units are characterized by their practicality compatible
with a wide range of devices for the modern ophthalmological
diagnostic. Thanks to an attentive selection of the materials and a wide
range of available colours and customizations, it is possible to create a
harmonious and comfortable working environment both for the
operator and the patient.
1.1 SYMBOLS
Within the information for use, on the package or on the device, there
can be the following symbols:
Symbol
Meaning
Caution
Danger of electric shock
Refer to instruction manual / booklet
General obligation
Note. Useful information for the user
General prohibition sign
Manufacturer

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CE Marking (EU Regulation 2017/745)
Medical device
Waste disposal in compliance with the Directive 2012/19/EU
(WEEE), and 2011/65/EU (RoHS II)
1.1.1 DEVICE SYMBOLS
Symbol
Meaning
Type B applied part
Fuse

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1.2 GENERAL WARNINGS
THIS INFORMATION FOR USE REFERS TO OPHTHALMIC UNIT,
MODEL FUTURE DELUXE ("DEVICE" FROM NOW ON).
THE ORIGINAL TEXT IS IN ITALIAN.
Before using the device or if you don't use it since a long time, read
carefully this information for use. Read the instructi
ons given in the
information manual and reported on the device.
The 'colour inside' logo on the cover page of this publication indicates that it
contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document
using a colour printer.
Keep this manual close by for future consultation. If you should
decide to sell this appliance to other people, remember to also
include these instructions, complete and readable.
Keep the original box and packaging, as the free-of-charge service
does
not cover any damage resulting from inadequate packaging of
the product when this is sent back to an Authorized Service Centre.
Verify the presence of damage signs on the device caused by the
transport/storage, before using the device.
It is forbidden to reproduce, totally or partially, texts and images
contained in this information for use without the written
authorization of the Manufacturer.
The Manufacturer reserves himself the right to modify the contents
of the information for use, without notice.

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1.3 NORMATIVE REFERENCES
1.3.1 COMMUNITY DIRECTIVES
- Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5th April 2017 on medical devices
- Directive 2012/19/EU on waste electrical and electronic equipment
(WEEE)
1.3.2 TECHNICAL STANDARDS
- IEC 60601-1: 2005 + A1:2012 - Medical electrical equipment - Part
1: General requirements for basic safety and essential performance
- EC 60601-1-2:2014 Edition 4 - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
- UNI CEI EN ISO 14971:2012 Medical devices. Application of risk
management to medical devices.
1.3.3 QUALITY MANAGEMENT SYSTEMS STANDARDS
- UNI CEI EN ISO 13485:2016 “Medical devices. Quality management
systems - Requirements for regulatory purposes".
1.4 WARRANTY
The Manufacturer is responsible for the device conformity to the
Regulation (EU) 2017/745 of April 5th 2017 for:
- features
- safety and reliability
- CE marking
The Manufacturer refuses any responsibility for:
- installation and activation not activated in conformity to the
indications and the precautions reported in the information for use
- use not in compliance with the information for use and precautions
reported in the information for use
- use of accessories or spare parts not provided or suggested by the
Manufacturer
- repairs and safety controls not effectuated by expert, qualified,
trained and personnel authorized by the Manufacturer

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- electrical system of the space where the device is installed not in
compliance with the technical standards, the laws and regulations
in effect in the country of installation of the device
- direct or indirect consequences or damages to objects or persons,
originating from the improper use of the device or erroneous
clinical analysis originating from its use
The Manufacturer guarantees the device for 24 months after invoicing.
The Warranty includes the substitution, at the Manufacturer's or an
Authorized Service Centre, of components and materials and the
relative labour. The shipping and transport fees are to be paid by the
client.
The warranty does not cover:
- repairs of faults originating from natural disasters, mechanical
shocks (fall, hit, etc), electrical system faults, negligence, improper
use, maintenance or reparations carried out with non-original
materials
- any other improper use or not intended by the Manufacturer
- damages caused by service lack or inefficiency, originating by
causes or circumstances out of the Manufacturers control
- the parts subject to usage and/or deterioration originating from
the normal use and those that might be broken because of an
improper use or maintenance carried out by personnel non-
authorized by the Manufacturer.
To ask maintenance interventions or to have technical information
about the device, address to an Authorized Service Centre or directly
to the device Manufacturer.
The client will not be refunded for damages originating from the
device halt.

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1.5 MANUFACTURER IDENTIFICATION
C.S.O. SRL
Costruzione Strumenti Oftalmici
Via degli Stagnacci, 12/E
50018 - Scandicci (FI) - ITALY
phone: [phone] - fax [phone]
[e-mail]
www.csoitalia.it

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2SAFETY
2.1 SAFETY WARNINGS
DANGER
Electric shock danger. Do not let water fall on any part of the
device.
Do not immerse any part of the device into the water or
other liquids.
DANGER
Electric shock danger. If the power cables are damaged, they must
be replaced in an Authorized Service Centre to prevent any risk.
DANGER
Electric shock danger. Unplug th
e power cable from the mains
socket before disinfecting the device and before any maintenance
operation.
CAUTION
Do not use the device if visibly damaged.
Periodically inspect the
device and the connection cables to verify if there are damage
signs.
CAUTION
Falling hazard. Do not leave free cables which can represent an
obstacle or a danger for the patient or the operator.
CAUTION
Danger of stumbling
and falling. Do not let the power cables or the
connection cables free in a place where people could walk.
CAUTION
Electric shock risk. Do not touch the power supply cables with wet
hands.

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CAUTION
Electric shock risk.
Do not leave the power supply cables in contact
with sharp corners or objects. Always collect and fasten the power
supply cables.
CAUTION
If you notice a wired odour or smoke coming out of the device or if
it emanates heat, turn it off immediately. Do
not keep using a
damaged device or a damaged part. Danger of injuries.
CAUTION
The power grid must have a Residual-
Current Circuit Breaker
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the device. Place the device in such a way that the power socket is
easily accessible.
It is forbidden to carry out any technical operation on the device that
is not recalled or described in these instructions for use.
It is forbidden to place the device in humid, dusty places or
environments subject to sudden temperature and humidity
variations.
It is forbidden to use any extension cable not authorized by the
device Manufacturer.
It is forbidden to use the device outdoors.
The device does not generate and does not receive any
electromagnetic interference if it is placed near other electrical
appliances. No preventive or corrective actions are required.

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2.2 DEVICE IDENTIFICATION
2.2.1 REGISTRATION DATA IN THE MEDICAL DEVICES REPERTOIRE
The device registration data can be verified on the Italian Ministry of
Health website at this page:
Ministero della Salute - Ricerca dispositivi
2.2.2 DEVICE DATA PLATE
Fig 1 - Data plate position
Pos
Description
A
Data plate
Fig 2 - Data plate for device model DELUXE 2 Fig 3 - Data plate for device model DELUXE 3

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2.3 INTENDED USE
FUTURE, models DELUXE 2/DELUXE 3, is an ophthalmic unit equipped
with the most sophisticated electronic controls that allows for the use
of several devices. Through a controlled handling from microprocessor
allows the optimal use of the equipment.
The device is equipped with an electrically movable table top, where 2
or 3 devices can be placed. A drawer is also provided for tonometer
housing. A ceiling light with 3 LED lights is also provided.
The ophthalmic unit has two new generation, shatterproof, touch
keypads, which are also backlit, easy to use and to clean. On the
keypads, all commands are available and it is possible to memorize all
the functions of the device for an easy and comfortable daily use.
Thanks to a microprocessor electronic control, the operator can
program various phases and options during an exam.
It is possible to command the chair elevation directly from the unit
keypad.
Some examples can be:
-LED ceiling light regulation, in such way that is turns off
automatically (or reaches the minimum luminous level) when the
table with the devices is placed near the patient (table closed),
-commands availability with the function of switch or bistable, so
that it is possible to command electric users that do not belong to
the ophthalmic unit,
-complete devices predisposition with table open or closed.
It is possible to connect other accessories to the device through the
analogical or digital interfaces.
The accessories (printer, modem, scanner, etc) must be installed
outside the patient area.
The accessories must be compliant to the norm IEC 60950-1
Information technology equipment - Safety -
Part 1: General
requirements.
If the accessories are installed in the patient area it is necessary to
install an isolation transformer compliant with the directive IEC
60601-1:2005 + A1:2012 - "Medical electrical equipment -
Part 1:
General requirements for basic safety and essential performance".

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The device must be only used by specialist practitioners and
operators (such as optometrists), within the limits of the law and the
regulations for the exercise of the profession.
Patient area: any volume in which a patient with applied parts can
intentionally or unintentionally come into contact with other electro-
medical devices or electro-
medical systems or with foreign masses
and masses or with other people in contact with these elements.
Fig 4 - Patient area
2.4 MEDICAL DEVICES CLASSIFICATION
Technical data
Value
Classification in compliance with the
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Class I

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2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification complying with the standard EN 60601-1:2005 + A1:2012
Technical data
Value
Type of protection against the direct
and indirect contacts
Class I
Applied parts
Type B
Protection degree against humidity
IP20 (no protection against liquid
infiltration)
Sterilization or disinfection method
This device can be disinfected
Protection degree in presence of
anaesthetics or inflammable
detergents
No protection
Electrical connection degree between
device and patient
Appliances with applied part on the
patient
Use conditions
Continuous functioning
2.6 ENVIRONMENTAL CONDITIONS
Phase
Technical data
Min
Max
Transport
Temperature
-40°C
+70°C
Atmospheric pressure
500 hPa
1060 hPa
Relative humidity
10%
95%
Storage
Temperature
-10°C
+55°C
Atmospheric pressure
700 hPa
1060 hPa
Relative humidity
10%
95%
Use
Temperature
+10°C
+35°C
Atmospheric pressure
800 hPa
1060 hPa
Relative humidity
30%
90%
CAUTION
Danger of device damages.
During transport and storage, the
device can be exposed to the environmental conditions for a
maximum period of 15 weeks, only if kept in the original packaging.

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2.7 DISPOSAL AT THE END OF THE USEFUL LIFE
Instruction for the correct disposal of the device according to
European Directive 2012/19/EU, and 2011/65/EU about the
reduction of use of dangerous substances in the electrical and
electronic equipment, as well as waste disposal.
At the end of its useful
life, the device must not be disposed of as
urban waste. The device can be delivered to the appropriate
separate waste collection centres set up by municipal
administrations or to retailers that offer this service. Separately
disposing of an electrical de
vice prevents possible negative
consequences for the environment and health, caused by its
improper disposal, and lets the materials it is made of to be
recycled so as to achieve significant savings of energy and
resources. On the label of the device there
is the symbol of the of
the crossed-out wheeled bin. The graphic symbol of the crossed-
out
wheeled bin, indicates the obligation to collect and dispose
separately the electrical and electronic equipment at the end of
their useful life.
The user has to consider the effects potentially dangerous for the
environment and the human health originating from an improper
disposal of the whole device or its parts.
In case the user wishes to dispose of the device used at the end of its
useful life, the Manufacturer facilitates the possibility of its reuse and
the recovery and recycling of the materials contained therein. This to
prevent the release of hazardous substances into the environment and
to promote conservation of natural resources. Before disposing of the
device, it is necessary to take into consideration the European and
national regulations that order what follows:
- not to dispose as urban waste but collect it separately and address
to a firm specialized in the disposal of electrical and electronic
equipment or to the local administration in charge for waste
collection.

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- in the event that a new device is purchased from the same
Manufacturer to replace an old one placed on the market before
13 August 2005, equivalent and with the same functions of the new
device, the Distributor or Manufacturer are legally required to
collect the old device.
- if the user decides to dispose a used device, put on the market
after the 13th August 2005, the Distributor or the Manufacturer
have to collect it.
- the Manufacturer takes care, by joining a consortium for electronic
waste, of the treatment and the recycling of the used device by
paying its costs.
The Manufacturer is available to give the user all the information
about the dangerous substances contained in the device, and on the
recycling modalities of those substances and about the possibility of
a reuse of the used device.
Strict sanctions for transgressors are provided for by law.
For specific information about the disposal in other countries than
Italy, contact the local Dealer.

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2.8 MANUFACTURER DECLARATIONS
2.8.1 ELECTROMAGNETIC EMISSIONS
The unit is designed to be used in a room with the following
electromagnetic characteristics:
The copy of the documentation of the electromagnetic compatibility
(EMC) can be demanded at any time to C.S.O. Costruzione Strumenti
Oftalmici SRL.
The device is compliant with all the requirements of electromagnetic
compatibility (EMC) decided by the norm CEI EN 60601-2-
40
"Electromedical devices".
The ophthalmic unit can be used in an electromagnetic environment
where the disturbances of radio-
frequency irradiated fields are
controlled.
The ophthalmic unit shall not be used near other devices that are not
components of the device itself. In case it is necessary, you should
make sure that their functioning in this configuration is regular and
safe.
If the ophthalmic unit performances are affected by other appliances,
remove the cause of the interference. For any doubts or explanations
contact the Manufacturer.
Do not use as ophthalmic unit components other devices than dose
indicated by the Manufacturer. They could cause an increase of the
devices' emissions and a reduction of the ophthalmic unit immunity.
For any doubts or explanations contact the Manufacturer.