Strumenti Oftalmologici

Instructions for Use and

Maintenance
Mod. VEGA
LED-based UV Emitter
CSO Srl - Costruzione Strumenti Oftalmici
 Via degli Stagnacci, 12/E - frazione BADIA A SETTIMO
50018 SCANDICCI (FIRENZE) - ITALIA

CONTENTS

DESCRIPTION AND USE ................................................................................................................ 3

STANDARD COMPONENTS .......................................................................................................... 4
AMBIENT CONDITIONS FOR SHIPPING, WAREHOUSING, AND USE ................................. 5
DATA PLATES AND LABELS ....................................................................................................... 5
COMMANDS AND SIGNALS ......................................................................................................... 8
INSTALLATION AND COMMISSIONING.................................................................................... 9
ASSEMBLY ...............................................................................................................................................................10
CONNECTIONS ........................................................................................................................................................11
ELECTRICAL SAFETY: GENERAL PRECAUTIONS AND SAFETY WARNINGS ................ 12
USE CONDITIONS, WARNINGS, AND PRECAUTIONS .......................................................... 13
EMISSION POWER CHECK.......................................................................................................... 14
INSTRUCTIONS FOR USE ............................................................................................................ 16
DISPLAY FUNCTIONS .................................................................................................................. 17
TREATMENT PROCEDURE ......................................................................................................... 18
TECHNICAL FEATURES .............................................................................................................. 19
REGULATORY COMPLIANCE INFORMATION ....................................................................... 20
EQUIPMENT CLASSIFICATION ................................................................................................. 20
EQUIPMENT LIFECYCLE ............................................................................................................ 21
ROUTINE MAINTENANCE .......................................................................................................... 22
CLEANING THE OUTER SURFACES ....................................................................................................................22
PROTECTION FROM DUST ....................................................................................................................................22
REPLACING THE LINE FUSES ..............................................................................................................................22
PERIODIC SAFETY CHECKS....................................................................................................... 23
END-OF-LIFE DISPOSAL INFORMATION ................................................................................ 24
LIABILITY ...................................................................................................................................... 27

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 DESCRIPTION AND USE
VEGA is a medical electrical device designed and built by CSO Srl.
It consists of a LED light source that radiates in the ultraviolet
spectrum (UV-A).
The instrument is designed to be used exclusively for treatment of
disorders of the cornea, in an ophthalmologic clinical setting and
only by expert specialized physicians. The VEGA emitter is
especially useful in treatment of keratoconus by corneal collagen
cross-linking. This technique consists in photo-polymerization of
the stromal fibers through the combined action of a photo-
sensitizing substance (riboflavin – Vitamin B2) and the UV
radiation generated by the instrument in question.
READ THIS MANUAL
CAREFULLY CSO Srl does not suggest any specific clinical use techniques or
therapeutic procedures. The way the instrument is used and therefore,
its association with particular pharmaceuticals and/or chemical agents,
are left to the discretion of the specialized user physicians on the basis
of their scientific knowledge and professional skills.

This manual provides all necessary instructions for practical use of the
instrument and points out safety precautions and measures that
operators should observe/take to minimize the risks directly connected
with the technical characteristics of the instrument and in particular
with emission of UV radiation.

CSO Srl assumes no responsibility for damages or injury to patients,

operators, and/or other persons attributable to improper or imprudent
use of the instrument in manners different from those described in this
manual, and in particular in case of failure to observe the safety
precautions and measures outlined herein.

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 STANDARD COMPONENTS
The devise is composed of the following principal units:
1- OPTICAL HEAD
2- BALANCE ARM
3- CONTROL BOX
4- STAND
5- FOOT SWITCH

Standard accessories:
- Power cord
- Wrenches for assembly
- UV light meter
- This use and maintenance manual.

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 4 of 27

 AMBIENT CONDITIONS FOR SHIPPING,
WAREHOUSING, AND USE
As long as the instrument remains in its original packing it may be
exposed to the environmental conditions listed below, for a maximum
of 15 weeks during shipping and warehousing, without suffering
damage:
Attention!
Temperature between -10 °C and +60 °C,
atmospheric pressure between 500 hPa and 1060 hPa, and
relative humidity between 10% and 90%.
Ambient conditions for operation are, instead:
Temperature between +15 °C e +30 °C;
atmospheric pressure between 700 hPa and 1060 hPa, and
relative humidity between 30% and 75%.

DATA PLATES AND LABELS

C.S.O. srl
Via degli Stagnacci, 12/E
50010 SCANDICCI
(FIRENZE) - ITALY

UV EMITTER Mod. VEGA

SERIAL NUMBER ………………….

INVISIBLE
LED
RADIATION
DO NOT VIEW DIRECTLY
WITH OPTICAL
INSTRUMENTS
CLASS 1M
LED LED LASER
APERTURE PRODUCT
(EN 60825-1:2003)

OPTICAL HEAD data plate

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 C.S.O. srl - Via degli Stagnacci, 12/E
50010 SCANDICCI (FIRENZE) - ITALY
INPUT
100-120 V 18VA
OUTPUT
CONTROL BOX FUSES 2 x 315 mA - 5x20 - T type (IEC 127) Emission power: 4 mW (max)
Mod. VEGA 230-240 V 18VA Wavelength: 370 nm
FUSES 2 x 160 mA - 5x20 - T type (IEC 127)
Bandwidth: 8 nm
FREQ. 50/60 Hz

SERIAL NUMBER
…………………. 0051
SEE USER MANUAL

CONTROL BOX data plate

FRONT PANEL

UV ---- Yellow light. Indicates UV-A emission from optical head.

--- Red light. Malfunction indicator.

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 REAR PANEL

Explanation of Graphics Symbols on Data Plates

0051 “CE mark” attesting to product compliance

with European Union Directive 93/42/EEC (“Medical
Type B. Even though the instrument has no applied Devices”). The code number identifies the notified standards
parts as such, the leakage current values are within type B limits organization (IMQ) charged with verifying compliance of the
(EN 60601 safety standard for electrical medical devices). product and the manufacturer’s quality system.

General warning of the user’s duty to read the

Notice of duty to separately collect and dispose of end-
instruction manual carefully before installing, commissioning,
and using the instrument. of-life electrical and electronic equipment (see section on this
topic).

Ground connection.

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 7 of 27

 COMMANDS AND SIGNALS

1.3- UV SPOT APERTURE CONTROL

2.1- ARM LOCK
3.1- UV EMISSION INDICATOR (yellow light)
3.2- MALFUNCTION INDICATOR (red light)
3.6- MAIN SWITCH
3.9- CONTROL BOX ROTATION LOCK
5- FOOT SWITCH

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 INSTALLATION AND COMMISSIONING
Our instruments are always supplied packed in such a manner as to
best withstand standard shipping and warehousing conditions.
Should you notice defects attributable to shipping when unpacking
Attention! the instrument, contact your installation service or the manufacturer.
Before switching on and
using the instrument, read
this manual, and this
chapter in particular, - Check that your mains voltage is compatible with the
carefully. specifications on the data plate of the instrument. If not, contact
the technical assistance center or the manufacturer.
- Your entire electrical system must comply with the CEI 64-4
standard or the more recent CEI 64-8 sect. 710 (Electrical
Systems for Medical Use). In case of doubt, contact your
electrical system installation and maintenance service.
- Never use multiple plugs, adapters, or extension cords to
connect the instrument plug to the mains socket.
- When unplugging the instrument from mains power supply,
even in an emergency, grasp the plug only; never pull the cord
to disconnect the plug.
- In order to avoid interruptions during treatment, we suggest
connecting the instrument through an emergency power supply.

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 ASSEMBLY

• Assemble the arm (2) on the column, inserting the plate (2.2) in the channel (4.1).
• Tighten the knob (2.1) to lock in place at correct height.

• Insert the optical head (3) onto the column (4).

• Adjust rotation friction by tightening the screw (4.2) with the wrench supplied for that
purpose.

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 10 of 27

 • Assemble the optical head (1) on the arm attachment (2.2).
• Lock in place with the wrench supplied for that purpose. (1.1)

CONNECTIONS
1.4- INSERT THE CONNECTOR
3.4- INSERT THE CONNECTOR (foot switch)
3.5- INSERT THE CONNECTOR FROM THE ARM
3.7- INSERT THE SOCKET CONNECTOR IN THE PLUG 3.7 (mains)
3.10- VIDEO OUT

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 ELECTRICAL SAFETY: GENERAL
PRECAUTIONS AND SAFETY WARNINGS
- Never touch the power cord with wet hands. Check frequently
that the cord is so placed as not to be stepped on or crushed by
Attention! weights. Never knot the cord.
- A damaged power cord can cause fires or electrical shocks.
Check frequently that the instrument power cord is in good
condition. If it becomes necessary to replace the power cord
supplied with the instrument, contact your supplier.
- Do not perform any repairs or maintenance work on the
instrument or the electrical system beyond what is explained in
this manual.
- Do not use the instrument near water and be careful not to spill
liquids on any part of it. Avoid damp and dusty locations and
locations subject to brusque changes in temperature and
humidity.
- Disconnect the instrument from the mains supply socket before
cleaning and/or disinfecting.
- The instrument neither generates nor receives electromagnetic
interference when used in proximity to other devices; no preventive
or corrective measures need therefore be taken.
- The standard-configuration instrument is tested in accordance with
international standards EN 60601-1 “Medical Electrical
Equipment. PART 1: General Requirements for Safety” and EN
60601-1 “Collateral Standard: Safety Requirements for Medical
Electrical Systems” and is fully compliant with these standards.
Note that the standard version unit can be connected to other
instruments, medical electrical and not; CSO cannot test the
compliance of all possible system configurations.
- Any additional accessories (video recorder, monitor, or similar
equipment) connected to the analog or digital interfaces must each
be certified in accordance with the respective pertinent standards.
All such devices must in any case be located outside of the patient
area.
- Once all the equipment making up the system has been connected
and assembled, check that the resulting medical electrical system
complies with the requirements set by EN 60601-1-1 “Collateral
Standard: Safety Requirements for Medical Electrical Systems.”
- Should the leakage current values exceed the limits set by the
pertinent standards, additional safety measures must be adopted as
laid down by the EN 60601-1-1 standard. In this case, the entire
system must be powered through a safety insulating transformer.
- Attention! Do not connect devices not forming part of the system to
the instrument.

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Attention!
Although the VEGA emitter is
not a true LASER, the risks of
damage to patients’ and
operators’ skin and eyes are
analogous.
LED RADIATION
AVOID EXPOSURE TO BEAM
DO NOT OBSERVE WITH
OPTICAL INSTRUMENTS
CLASS 1M LED DEVICE
(EN 60825-1:2003)
Mod. VEGA
USE CONDITIONS, WARNINGS, AND
PRECAUTIONS
The VEGA emitter requires no warm-up period. Emission begins
at the moment the instrument is switched on.
The user/operator must be aware of the general safety precautions
to be taken when using devices of this type and of those set forth
herein and on the safety labels on the VEGA emitter.
The instrument is intended for use only by correctly and
thoroughly trained personnel (specialized ophthalmologists) for
appropriate therapeutic purposes, based on clinical observation of
the tissues of the patients being treated.
Eyes and skin may be seriously damaged by the UV radiation
emitted by the instrument, as pointed out herein and reported in
specialized international literature.
Only the portion of the patient’s body that is to be treated should
be exposed to the UV radiation. Do not interrupt the UV path with
hands or objects.
Do not look at the light source. The UV radiation emitted by the
source is invisible.
The operators’ eyes must be protected with suitable goggles, as
must the eye of the patient that is not being treated.
Do not use the device if there is any damage to the casing, the
optical components, or the power cord.
Medical and surgical instruments and other objects made of
plastics present in the working environment may be damaged
and/or emit noxious gases if irradiated by the UV radiation emitted
by the device.
The radiation (UV light) may reflect off smooth surfaces in the
working environment, even if they are dark in color.
Keep the instrument on only for the time strictly necessary for
treatment.
WARNING – Using commands and/or settings or
running procedures different from those described in
this manual may cause exposure to dangerous levels
of radiation.
- Instructions for Use and Maintenance - rev. 7- Page 13 of 27
 POWER EMISSION CHECK
We recommend checking the intensity of the radiation emitted by the
instrument prior to each treatment.
The system is equipped with a UV meter (6) for checking power
emission. The accessory is composed of a detector head (6.2) and a
display (6.1).

The UV meter is an extremely delicate measurement instrument and it

must therefore be stored and handled with all dued precautions.
 When not in use, store the instrument, with its protective
cover, in a safe place not exposed to humidity or sources of
heat.
 Do not expose the instrument to extremes of temperature.
 Do not expose to strong vibrations.
 Do not use near sources of magnetic fields (motors,
transformers, etc.).
 Before taking any reading, allow a few minutes’ time on-site
for instrument temperature to stabilize.
 Replace the batteries immediately whenever the “BAT”
symbol is displayed.
 If the instrument is unused for a long period of time, remove
the batteries.
 Do not open the instrument or tamper with its parts.
 Control and calibration may be performed only at CSO.
 For further information regarding the UV meter, refer to the
original instruction manual.

The UV meter is an instrument that has been modified and is certified

by CSO. It may not be used for purposes other than those described

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 14 of 27

 herein.

To take a UV reading, proceed as outlined below:

1. Place the UV instrument on a flat horizontal surface.
2. The arm of detector head (6.2) and the optical head (6.5) must
be oriented as showed in the picture
3. Check that in the absence of emissions and interference, the
reading on the display (6.1) is “0” with a tolerance of +/-0.05
mW/cm² (zero reference reading).
4. Switch on the main switch (3.6) of the power supply (3).
5. Place the optical head (6.5) over the black sector of the yellow
label (Fig. 6.3) in the center of the UV meter and move it
toward the plane until the image on the black sector comes
into focus (the two red flashing lights overlap).
6. Switch on the UV emitter with the foot switch (5); in the
“POWER ON CHECK” mode, move the UV meter over the
plane until the UV emission intercepts the detector aperture
(Fig. 6.4) in the center. The diaphragm (1.3) must be adjusted
until the diameter of the emitted beam it is greater than the
hole in the center of detector head (Fig. 6.4).
7. On the display (6.1), read the power density value expressed
in mW/cm².
8. Press the foot switch again to move ahead to the treatment
Attention! phases.
The optimal measured value should be 3 mW/cm², or in any case
within a tolerance range of 2.7 to 3.3 mW/cm² otherwise waiting for
15’ in “POWER ON CHECK” mode after that repeat the
measurement.

Should the measured value not meet tolerance, check whether or

not:
a) The mains voltage is correct.
b) The cables are connected correctly.
c) The power supply fuses are good.
d) The head of the UV emitter is clean.
e) The UV meter batteries are charged.
f) The procedure described above has been carried out
correctly. If it be the case, repeat the entire procedure
from the beginning.
If the problem persists despite the above checks, contact your
retailer or CSO.

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 INSTRUCTIONS FOR USE

Switch on the main switch of the instrument (9).

Bring the optical head (1) toward the patient and center the image of
his/her eye at the center of the monitor screen.
For best results, the emitter must be correctly focused; the focus point
is located about 54 mm from the apex of the optical head. For quick
focus search, use the collimating light beams (1.2): two flashing
iridescent lines projected at a certain angle which when their paths
meet at a single point, permit finding the correct focus position (see
figure below).
Correct focusing ensures correct UV emission power density for
meeting medical procedure guidelines (3mW/cm²) only at this
focus point.
Attention!
OPTICAL HEAD

LUMINOUS SPOTS FOR FOCUSING

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DISPLAY FUNCTIONS
The instrument is equipped with a display (3.8) that supplies all the information relative to the
treatment procedure to be followed. The text line displays the TIME (3.8.3, minutes and seconds)
for each phase, the STATUS (3.8.2), and the single STEP (3.8.1) on which we are working.

STATUS (3.8.2)-
• WAIT- The instrument is waiting for a command to begin a phase or the entire
procedure.
• RUN- One of the operative phases is running.

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 • PAUSE- The foot switch has been pressed during a phase of the procedure and the
instrument is waiting for new input. Press the foot switch again to resume work from
the point of interruption.
• RESET- The foot switch has been held down for 10 seconds and the instrument is
consequently resetting to the top of the first phase.
STEP (3.8.1)-
The steps in memory are 7 in number and follow the procedure dictated by medical
practice guidelines. The first phase (STEP 0) is the only step that may be modified by the
physician. This phase lasts 30’ but mat be interrupted to go on to step 1. Steps 1 through
6 each have a duration of 5’ for a total 30’.
TIME (3.8.3)-
The elapsed time for each step is displayed in minutes and seconds.
STATUS (3.8.4)-
• POWER ON CHECK- The first phase of operation: the power check to be
conducted with the aid of the UV meter. During this phase, the display show the
version of firmware and the operating parameters that must be communicated in
the event of a request for assistance.
• RESUMED- The system has resumed operation from the phase and time at which
power supply was interrupted.

If treatment is interrupted due to failure of the external power supply, the system memorizes the
elapsed treatment time. When the instrument is repowered, treatment can be resumed from the
point in time stored in memory.

TREATMENT PROCEDURE
• Position the optical head above the patient and align it, finding the focus point as
described above.
• Press the foot switch to start step 0.
• After 30’, at the physician’s discretion, press the footswitch again to return to WAIT
status.
• Press the foot switch to start step 1, which will last 5’. The system will then
automatically shift to WAIT status awaiting the next step.
• Proceed with the remaining steps until the entire procedure is concluded.
• Upon termination of step 6, the system will automatically return to WAITing for step 0.

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 TECHNICAL FEATURES
Power supply Single phase AC mains supply 100, 120, 230, 240 V, 50/60 Hz
Rated power 18 VA (max)

UV source LED emitting in the UV-A spectrum

Emission Peak wavelength: 370 nm
characteristics Spectrum width: 8 nm (at half amplitude)

Emission spectrum
Radiated power 4 mW (max)
Radiated power 3 mW/cm2 (max)
density
Diameter of Variable
irradiated area Min Ø 4mm Max Ø 11 mm
Collimation 1 pair red LEDs
Work distance 54 mm
Fixation Fixation LED green color
Video camera In optical head
Minicamera, ¼”, color, model ECH-3030ST
Monitor Display monitor, 5.6”, color, model SJD-56S
Video out 75-Ohm PAL video-composite output
Dimensions 1260 – 545 – 1360 mm
Weight 20 kg

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 REGULATORY COMPLIANCE
INFORMATION
The VEGA is designed and built in compliance with EU
Directive 93/42/EEC and the following harmonized standards:
− CEI EN 60601-1:1991 “Medical Electrical Equipment – Part
1: General Requirements for Safety" as amended.
− CEI EN 60825-1:2003 – “Safety of Laser Products - Part 1:
Equipment Classification, Requirements, and User Guide.”
− CEI EN 60601-1-2:2001 - “Medical Electrical Equipment –
Collateral Standard: Electromagnetic Compatibility.”

EQUIPMENT CLASSIFICATION

According to EN 60601-1
safety standard Portable device (movable from one location to another).

Protection against direct and indirect electrical shock:

Class I

Type B

Compliance level for protection against humidity:

Common devices (IP20)
(no protection against infiltration of water)

Method of sterilization or disinfection:

Disinfectable device

Compliance level for protection in the presence of inflammable

anesthetic mixtures:
No protection

Use conditions: continuous service

According to CEI EN
60825-1 safety standard LED RADIATION in the UV-A range, class 1M, for medical
use.

According to Annex IX of
Directive 93/42/EEC Class II b (Rule 9, Annex IX)

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 EQUIPMENT LIFECYCLE
Regular maintenance, as specified in the use and maintenance
manual, permits maintaining the basic characteristics of the
equipment unaltered for many years, even when it is subjected
to intense use.
It is nevertheless normal for the device to gradually age; aging
is in strict relation to the manner and frequency of use (wear of
mechanical parts, drift of electrical/electronic components,
deterioration of insulation).
For reasons of prudence, the working life of the device is
therefore set at ten years from the date of commissioning
(re: Annex I – Directive 93/42/EEC).

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 ROUTINE MAINTENANCE
The device requires no particular routine maintenance by the user.

CLEANING THE OUTER SURFACES

Clean the external surfaces of the instrument with a cloth slightly
dampened with water. Do not use thinners or solvents.
Attention!

Unplug the power cord from PROTECTION FROM DUST

mains supply before When the instrument is not in use, protect it from dust by covering
performing any of the it with the protective cover.
routine maintenance Periodically remove any dust that has accumulated on the
operations illustrated instrument with a very soft cloth or a hand-operated pump.
in this section.
REPLACING THE LINE FUSES
Extract the fuse-holder box (3.7.1) and replace the blown fuses
with new fuses of the same rating.
To replace the line fuses, proceed as described below.
- Before beginning any work, unplug the instrument to isolate
power supply.
- Extract the fuse-holder box (3.7.1) and remove the blown
fuses.
- Replace the old fuses with new ones compatible with mains
power supply, as indicated on the data plates.
Attention! - Check that the voltage changer on the fuse-holder box (3.7.1)
is set to the correct voltage value for your mains supply. If not,
Special maintenance extract the box (3.7.2) and turn until the correct voltage value
(repairs, replacement of appears in the window.
components, internal parts - Replace the voltage-changer/fuse-holder box.
checks, periodic safety - Plug in the instrument.
checks, etc.) is the exclusive
competence of the CSO
technical assistance service.
In the event of request for
assistance, the version of
firmware and the operating
parameters must be
communicated to CSO, see
pag.18 (3.8.5)

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 PERIODIC SAFETY CHECKS
We recommend having the Mod. VEGA checked periodically, as
recommended by the CEI Guide 62-122:2002 concerning acceptance
testing and periodic checkouts of the performance and/or safety of
medical devices powered by particular power sources, by a technical
service center authorized by CSO srl.
Attention! The Mod. VEGA instrument is designed and built in full compliance
with applicable laws and standards and must pass rigorous safety
The periodic safety checks testing before leaving the factory. We nevertheless recommend (as the
are the exclusive above-mentioned standard suggests for all medical electrical
competence of the CSO equipment) conducting a safety checkout once every two years in
technical assistance service. accordance with applicable procedures, in order to limit the possibility
of breakdowns and/or falloffs in performance levels.

Please contact CSO srl for further information.

Letteratura tecnico-scientifica di riferimento

N Treatments Clinical evidence Contra-indications Side effects Limit
ations
° on use

1 Medical Scientific Scientific literature: To be excluded in cases of - Transitory

treatment of “Terapia medica del cheratocono patients with reduced corneal corneal edema -
keratoconus mediante cross-linking del collagene thicknesses (< 400 µm) - Sensation of
corneale con riboflavina- foreign body for
ultravioletto” (2005) 24-48 hours
(Medical Therapy of keratoconus by - Burning
corneal collagen cross-linking with sensation in eye
riboflavin-ultraviolet radiation) and lachrymation
Authors: Caporossi, Mazzotta, Traversi,
Baiocchi et al.
Department of Ophthalmological and
Neurosurgical Sciences –
Ophthalmology Complex - Siena
University.
Eye Clinic – “Carus” Technical
University - Dresden

Further Bibliography:
WOLLENSAK, SPOERL et al. “Riboflavin/Ultraviolet-A-induced collagen cross-linking
for the treatment of keratoconus.” American Journal Ophtalmol – 2003.
WOLLENSAK, SPOERL et al. “Endothelial cell damage after Rriboflavin-Ultraviolet–A
treatment in the rabbit.” J Cataract Refract Surg, 2003.
WOLLENSAK, SPOERL et al. “Keratocyte apoptosis after corneal collagen cross-linking
using Riboflavin/UV-A treatment.” Cornea, 2004.

See also: expertise document by Caporossi, Mazzotta, Baiocchi, August 2006.

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 23 of 27


The symbol (barred waste
can) shown in the figure and
found on the exterior of the
instrument indicates that the
electrical and electronic parts
of the end-of-life instrument
must be separated and
disposed of as special waste.
Mod. VEGA - Instructions for Use and Maintenance - rev. 7-
END-OF-LIFE DISPOSAL INFORMATION
in accordance with Art. 13 of the Italian Leg. Decree No. 151
of 25 July 2005 implementing Directives
2002/95/EC, 2002/96/EC, and 2003/108/EC
concerning reduction of use of dangerous substances
in electrical and electronic equipment
and disposal of electrical and electronic waste.
The instrument you have purchased is made using particular materials and
substances. It may also contain substances having potentially dangerous
effects on the environment and human health if released into the environment
by improper disposal.
To avoid releasing dangerous substances into the environment and in order to
promote conservation of natural resources, should the user decide to dispose
of an end-of-life instrument the manufacturer will facilitate reuse and
recovery and recycling of the materials it contains.
Government agencies have adopted measures obliging users, distributors, and
manufacturers to contribute to collection of waste electrical and electronic
equipment (WEEE) and prescribes that such equipment be reused or be
recovered or recycled.
When disposing of the instrument, remember that disposal is regulated by
precise European and national laws and regulations that prescribe the
following:
- Do not dispose of the instrument as ordinary municipal waste. For
separate collection contact a company specialized in disposal of waste
electrical and electronic equipment or your local waste disposal agency for
information.
- If a new instrument is purchased from the same manufacturer to replace an
end-of-life instrument put on the market before 13 August 2005, of an
equivalent type and performing the same functions as the new device, the
distributor or manufacturer is required by law to take back the end-of-life
device.
- If the user intends to dispose of a used device put on the market after 13
August 2005, the distributor or manufacturer is required by law to take back
the device.
- The manufacturer is responsible for transporting, treating, and recovering
and/or recycling any used equipment collected and for all relevant expenses
- Do not forget that dangerous substances present in waste electrical and
electronic equipment and/or improper use of same or parts of same can
have potentially adverse effects on the environment and human health.
The instrument described in this manual contains metal and plastic
mechanical parts, electrical components, and electronic circuit cards. The
manufacturer is at user’s complete disposition for any information requested
regarding the dangerous substances contained in the instrument and recovery
and recycling procedures and/or the possibility of re-using the end-of-life
instrument.
Current legislation provides severe sanctions in the case of failure to respect
disposal laws and regulations in force.
Page 24 of 27
APPENDIX

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 25 of 27

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 26 of 27
 LIABILITY

CSO srl assumes responsibility for instrument compliance

with European Directive 93/42/EEC, its performance, safety,
and reliability, in the terms and within the limits set by current
pertinent laws and regulations.

CSO srl nevertheless declines said responsibility if:

− installation and start-up are not performed in accordance
with the instructions and precautions set forth in this
manual.;
− the instrument is used in ways not in accordance with the
instructions and precautions set forth in this manual;
− accessories and/or spare parts not supplied or recommended
by CSO srl are used:
− repairs and safety checks are performed by persons other
than competent, qualified, and suitably-trained personnel
authorized by CSO srl;
− the electrical system of the installation site does not comply
with CEI standards and the pertinent laws and regulations in
force.

CSO srl also declines any and all responsibility for direct or
indirect consequences and/or damage to persons and/or things
deriving from improper use of the instrument and/or from
erroneous clinical evaluation of information derived from its
use.

CSO srl
Costruzione Strumenti Oftalmici
Via degli Stagnacci, 12/E
50010 Badia a Settimo - Scandicci , Firenze ITALIA
Phone: + 39 055 722191 - FAX + 39 055 721557

Email: cso@csophthalmic.com
www.csophthalmic.com

Mod. VEGA - Instructions for Use and Maintenance - rev. 7- Page 27 of 27