CSO VINTAGE User manual

VINTAGE
COSTRUZIONE STRUMENTI OFTALMICI
1/174
EN
INSTRUCTIONS FOR USE
Ophthalmic unit
IFU320EN01.00 - 02/2022
COSTRUZIONE STRUMENTI OFTALMICI
phone: [phone] | fax: [phone]
[email protected] | www.csoitalia.it

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INSTRUCTIONS FOR USE
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1INTRODUCTION......................................................................................... 3
1.1 SYMBOLS .......................................................................................................... 3
1.1.1 Device symbols ..................................................................................................... 4
1.2 GENERAL WARNINGS ........................................................................................... 4
1.3 NORMATIVE REFERENCES ..................................................................................... 5
1.3.1 Community directives ........................................................................................... 5
1.3.2 Technical standards.............................................................................................. 5
1.3.3 Quality management systems standards ............................................................. 5
1.4 WARRANTY ....................................................................................................... 6
1.5 MANUFACTURER IDENTIFICATION ........................................................................... 7
2SAFETY....................................................................................................... 8
2.1 SAFETY WARNINGS .............................................................................................. 8
2.2 DEVICE IDENTIFICATION...................................................................................... 10
2.2.1 Registration data in the Medical Devices List ..................................................... 10
2.2.2 Device data plate................................................................................................ 10
2.3 INTENDED USE.................................................................................................. 11
2.4 MEDICAL DEVICES CLASSIFICATION ........................................................................ 12
2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION......................................................... 13
2.6 ENVIRONMENTAL CONDITIONS ............................................................................. 13
2.7 DISPOSAL AT THE END OF THE USEFUL LIFE .............................................................. 14
2.8 MANUFACTURER DECLARATIONS .......................................................................... 16
2.8.1 Electromagnetic emissions ................................................................................. 16
3DEVICE DESCRIPTION .............................................................................. 17
3.1 SUPPLY DESCRIPTION ......................................................................................... 17
3.1.1 VINTAGE ophthalmic unit ................................................................................... 19
3.1.2 Command keypad on the structure .................................................................... 22
3.1.3 Chin rest (optional) ............................................................................................. 23
3.1.4 Drawer (optional) ............................................................................................... 24
3.1.5 Chair (optional) .................................................................................................. 25
3.2 ACCESSORIES FOR PLACING THE DEVICE (OPTIONAL) ..................................................26
3.3 TECHNICAL DATA .............................................................................................. 27
3.4 OPHTHALMIC UNIT BULK..................................................................................... 28
4DEVICE USE ............................................................................................. 29
4.1 HOW TO INSTALL THE OPHTHALMIC UNIT ................................................................ 29
4.2 HOW TO INSTALL STICKER PAD FOR PLACING THE DEVICE ON THE TABLE TOP .................... 29
4.3 HOW TO PLACE THE CHIN REST ............................................................................. 31
4.4 HOW TO PLACE DEVICES ON THE TABLE TOP............................................................. 32
4.5 HOW TO CONNECT THE OPHTHALMIC UNIT.............................................................. 34
4.6 HOW TO TURN ON THE OPHTHALMIC UNIT .............................................................. 35
4.7 HOW TO RESET THE CHAIR................................................................................... 37
4.8 HOW TO SET FUNCTIONS .................................................................................... 38

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4.8.1 Functions setting ................................................................................................ 38
4.8.2 Setting the slit lamp light intensity..................................................................... 39
4.8.3 Adjusting the spotlight intensity......................................................................... 40
4.8.4 Setting buttons AUX1 and AUX2 ........................................................................ 41
4.9 HOW TO USE THE AUX FUNCTION........................................................................ 41
4.10 HOW TO USE THE KER AND OPT BUTTONS ............................................................ 42
4.11 HOW TO PLACE THE TABLE TOP TO EXAMINE THE PATIENT........................................... 43
4.11.1 How to place the table top to examine mobility impaired patients.................... 45
4.12 HOW TO TURN OFF THE DEVICE............................................................................ 46
4.13 HOW TO USE THE OPHTHALMIC UNIT IN THE EVENT OF ELECTRICAL FAILURE .................... 47
4.14 HOW TO MOVE AND DISASSEMBLE THE OPHTHALMIC UNIT ......................................... 48
4.14.1 Disassembling the ophthalmic unit .................................................................... 48
4.14.2 Transporting the ophthalmic unit....................................................................... 49
5ORDINARY MAINTENANCE ......................................................................50
5.1 SAFETY WARNINGS ........................................................................................... 50
5.2 DEVICE CLEANING............................................................................................. 50
5.3 NETWORK FUSES REPLACEMENT........................................................................... 51
5.4 SPARE PARTS AND ACCESSORIES LIST ..................................................................... 52
5.5 TROUBLESHOOTING .......................................................................................... 53

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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 instructions for use, on the package or on the device, there
can be the following symbols:
Symbol
Meaning
Caution
Danger of electric shock
Read the instructions for use
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
1.2 GENERAL WARNINGS
THESE INSTRUCTIONS FOR USE REFER TO THE DEVICE
OPHTHALMIC UNIT, MODEL VINTAGE (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
these instructions carefully. Read the instructions given in the
instruction manual and reported on the device.
Keep this manual close by for future consultation. If you should
deci
de to sell this appliance to other people, remember to also
include these instructions, complete and readable.

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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.
Before using the device, check that there is no sign of damages due
to transport or an incorrect storage, that could compromise the
correct functioning of the device.
It is forbidden to reproduce, totally or partially, texts or images
contained in these instructions for use without the written
authorization of the Manufacturer.
The Manufacturer reserves himself the right to modify the contents
of the instructions for use, without notice.
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".

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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 instructions for use
- use not in compliance with the instructions for use and precautions
reported in the instructions 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
- 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.

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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.
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 the 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
Always keep the device out of the reach of children.
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 technic
al operation on the device that
is not recalled or described in the 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 electric
al
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 LIST
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
Device data plate
Fig 2 - Device data plate

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2.3 INTENDED USE
VINTAGE is an ophthalmic unit which allows to place four devices on
the movable table top.
Thanks to the table top rotation, you can easily and efficiently pass
from one device to the other.
It is equipped with a keypad from which instruments can be used and
all functions can be programmed for a fast and comfortable use.
It is also possible to command chair elevation directly from the unit
keypad.
It is also possible to command the table elevation directly from the
keypad.
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".
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.

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Fig 3 - 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
-10°C
+60°C
Atmospheric pressure
500 hPa
1060 hPa
Relative humidity
10%
90%
Storage
Temperature
-10°C
+55°C
Atmospheric pressure
700 hPa
1060 hPa
Relative humidity
10%
95%
Use
Temperature
+15°C
+30°C
Atmospheric pressure
700 hPa
1060 hPa
Relative humidity
30%
75%
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 package.

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2.7 DISPOSAL AT THE END OF THE USEFUL LIFE
Instruction for the correct disposal of the device according to
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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 pos
sibility 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 device 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 device can be used in an electromagnetic environment where the
disturbances of radio-frequency irradiated fields are controlled.
The device 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 device performances are affected by other appliances, remove
the cause of the interference. For any doubts or explanations contact
the Manufacturer.
Do not use as device components other devices than dose indicated
by the Manufacturer. They could cause an increase of the devices'
emissions and a reduction of the device immunity. For any doubts or
explanations contact the Manufacturer.

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3DEVICE DESCRIPTION
3.1 SUPPLY DESCRIPTION
Fig 4 - Supply description

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Pos
Denomination
Description
A
VINTAGE ophthalmic unit
The unit is composed of 4 table tops.
On each table top you can place one
medical device. On the central table
top you can place a fifth medical
device.
B
Hex wrench
C
Chair power cable
For connecting the chair to the
ophthalmic unit
D
Power supply cable of the
ophthalmic unit
For connecting the ophthalmic unit to
the power supply
If requested, the ophthalmic unit can be personalised with the
following accessories:
- VINTAGE ophthalmic unit, version with table top opening on the
left
- accessories for placing the devices on the table top (scrolling plate
and cogged guides)
- chair with electrical elevation
- ceiling light with three LEDs (for column)
- self-balancing arm for phoropter
- support for phoropter arm
- support for column table top
- hook for ophthalmic electrode cap
- various supports for column
- table top for LCD monitor (for column)
- digital video system
- controlled drawer to be connected to an ophthalmic unit
- finishing with special materials.
For the list of accessories and available models, contact the
Manufacturer or the local Distributor.