CSO VEGA Fiche technique

Strumenti Oftalmologici

Instructions for Use and

Maintenance

Mod. VEGA 10mW

LED-based UV Emitter

CSO Srl - Costruzione Strumenti Oftalmici

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 2 of 25

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 ........................................................................................................................................................12

ELECTRICAL SAFETY: GENERAL PRECAUTIONS AND SAFETY WARNINGS................12

POWER EMISSION 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......................................................................................................................................25

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 3 of 25

READ THIS MANUAL

CAREFULLY

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.

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.

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 4 of 25

STANDARD COMPONENTS

The devise is composed of the following principal units:

1- OPTICAL HEAD

2- BALANCE ARM

2.3- OPTICAL HEAD LOCK

3- CONTROL BOX

4- STAND

5- FOOT SWITCH

Standard accessories:

- Power cord

- Wrenches for assembly

- UV light meter

- Adapter holder

- This use and maintenance manual.

2.3

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 5 of 25

Attention!

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:

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 ………………….

LED

APERTURE

INVISIBLE

LED

RADIATION

DO NOT VIEW DIRECTLY

WITH OPTICAL

INSTRUMENTS

CLASS 1M

LED LASER

PRODUCT

(EN 60825-1:2003)

OPTICAL HEAD data plate

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 6 of 25

C.S.O. srl - Via degli Stagnacci, 12/E

50010 SCANDICCI (FIRENZE) - ITALY

CONTROL BOX

Mod. VEGA

INPUT

100-120 V 18VA

FUSES 2 x 315 mA - 5x20 - T type (IEC 127)

230-240 V 18VA

FUSES 2 x 160 mA - 5x20 - T type (IEC 127)

FREQ. 50/60 Hz

OUTPUT

Emission power: 10 mW

Wavelength: 370 nm

Bandwidth: 8 nm

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.

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 7 of 25

REAR PANEL

Explanation of Graphics Symbols on Data Plates

Type B. Even though the instrument has no applied

parts as such, the leakage current values are within type B limits

(EN 60601 safety standard for electrical medical devices).

General warning of the user’s duty to read the

instruction manual carefully before installing, commissioning,

and using the instrument.

Ground connection.

0051 “CE mark” attesting to product compliance

with European Union Directive 93/42/EEC (“Medical

Devices”). The code number identifies the notified standards

organization (IMQ) charged with verifying compliance of the

product and the manufacturer’s quality system.

Notice of duty to separately collect and dispose of end-

of-life electrical and electronic equipment (see section on this

topic).

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 8 of 25

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

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 9 of 25

Attention!

Before switching on and

using the instrument, read

this manual, and this

chapter in particular,

carefully.

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

the instrument, contact your installation service or the manufacturer.

-Check that your mains voltage is compatible with the

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.

-Do not to touch the video output and the patient at the same

time.

-Please take care during the transportation to avoid the tilting of

the equipment. Please be sure to hold the arm in the lower

position with the final part 90° tilted as indicated in the picture

below

90°

Mod. VEGA 10mW -Instructions for Use and Maintenance - rev. 8- Page 10 of 25

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.

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