SCHWIND ESIRIS Manuel utilisateur

EXCIMERLASER

ESIRIS

SERVICE MANUAL

Schwind GmbH

Mainparkstrasse 6-10

D-63801 Kleinostheim

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INDEX PAGE

1. SECURITY OF DEVICE (LASER BEAM) ...........................................................................................5

GENERAL...................................................................................................................................................5

Alarm Shields and Type Shield............................................................................................................6

Accessible Beam Area.........................................................................................................................7

Protection Glasses...............................................................................................................................7

Working Gas........................................................................................................................................8

Gas containment:.................................................................................................................................8

DECLARATION OF MANUFACTURER (MPG)......................................................................................9

2. DESCRIPTION ..................................................................................................................................10

SPECIFICATION ........................................................................................................................................10

EXCIMER-LASER ......................................................................................................................................12

GAS SUPPLY............................................................................................................................................13

GASCONTAINMENT:..................................................................................................................................13

DELIVERY SYSTEM...................................................................................................................................14

MICROSCOPE AND ILLUMINATION ..............................................................................................................14

CONTROLLING..........................................................................................................................................15

PATIENT BED...........................................................................................................................................15

FOOT SWITCH..........................................................................................................................................15

RINSING OF OPTICAL BEAM DELIVERY SYSTEM .........................................................................................15

3. INSTALLATION REQUIREMENTS AND PREPARATIONS.............................................................17

WORKING ROOM......................................................................................................................................17

DIMENSIONS ESIRIS................................................................................................................................18

INPUT REQUIREMENTS .............................................................................................................................19

INSTALLATION AND ROOM PREPARATIONS FOR THE INSTALLATION...............................................................20

Minimum room dimensions (or room requirements)..........................................................................20

FLOOR REQUIREMENTS ............................................................................................................................20

INSTALLATION REQUIREMENTS .................................................................................................................20

Laser warning lamp ...........................................................................................................................21

Dimensions of boxes for the delivery.................................................................................................21

DELIVERY ................................................................................................................................................22

4. SOFTWARE DESCRIPTION BY SERVICE LOGIN..........................................................................23

MENU EXTRA ...........................................................................................................................................23

Menu Logfile ......................................................................................................................................23

Menu Parameter................................................................................................................................24

Distributor adress...............................................................................................................................25

MENU SERVICE........................................................................................................................................27

Menu Laser:.......................................................................................................................................29

Menu Scanner: ..................................................................................................................................35

Menu digital inputs / outputs..............................................................................................................36

Gascontainment:................................................................................................................................39

MENU ADJUSTMENT:.................................................................................................................................40

Laser:.................................................................................................................................................40

MENU TECHNICAL SECUTITY CHECK (TSC)...............................................................................................44

5. UNPACKING AND CONTROLLING.................................................................................................45

PUTTING INTO OPERATION........................................................................................................................46

WARRANTY..............................................................................................................................................47

6. DISMANTLING OF THE ESIRIS-LASERS .......................................................................................48

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REMOVAL OF GAS BOTTLES (PREMIX AND HELIUM) .....................................................................................48

6.2 UNPLUG ELECTRICAL CONNECTIONS OF PATIENT BED, CAN-BUS MODULE AND GASCONTAINMENT........52

6.3 DISMANTLING OF OPTICAL PARTS........................................................................................................54

Dismantling of microscope :...............................................................................................................54

Dismantling CCD camera tower: .......................................................................................................55

Dismantling Scanning mirror..............................................................................................................57

NITROGEN GAS CYLINDER................................................................................................................59

DISMANTLE MONITOR AND KEYBOARD..........................................................................................59

DISCONNECTION OF THE FLUENCE DETECTOR............................................................................61

DISMANTLING THE PATIENT BED ...............................................................................................................61

DISMANTLING LASER................................................................................................................................62

7 INSTALLATION OF THE ESIRIS-LASER .........................................................................................63

ASSEMBLING THE LASER ..........................................................................................................................63

ASSEMBLING OF THE PATIENT BED ...........................................................................................................63

ELECTRICAL CONNECTION OF PATIENT BED, CAN-BUS-MODULE AND GAS-CONTAINMENT.........................66

ASSEMBLING OF MONITOR AND KEYBOARD ...............................................................................................67

ASSEMBLING OF THE LASER BEAM DELIVERY SYSTEM...............................................................................68

Assembling the Microscope:..............................................................................................................68

Assembling CCD-Camera Tower ......................................................................................................69

Assembling the Scanner....................................................................................................................70

CONNECTION OF THE NITROGEN BOTTLE ..................................................................................................70

ASSEMBLING FLUENCE DETECTOR............................................................................................................71

CONNECTION OF THE GAS MANAGEMENT TO THE OPTEX LASER ................................................................71

8. ALIGNMENT OF THE ESIRIS...........................................................................................................73

APPENDIX.............................................................................................................................................74

APPENDIX A: CALCULATION BASIS............................................................................................................74

A1. Introduction..................................................................................................................................74

A2. Correction of Myopia...................................................................................................................75

APPENDIX B: BEAM DELIVERY SYSTEM.....................................................................................................76

B1. Optical System............................................................................................................................76

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1. Security of Device (Laser beam)

General

The SCHWIND ESIRIS is working with a pulsed UV-Laser. The Laser belongs to

class 4, which is the one with the highest danger potential. In any case, exposition of

eye or skin through direct or scattered laser beams has to be avoided. A professional

instrument maintenance - done in the planned intervals - secures that unintended

beams can not be exposed of the unit.

Opening of the device is only allowed through trained technicians. All persons,

assisting the treatment or attending the procedure have to be informed about danger

potentials and have to wear protection glasses.

Besides the high-performance laser, the SCHWIND ESIRIS uses three diodelasers

as positioning and fixation device. The output of the fixation laser is below 10 µW.

Therefore it belongs to class 1, which allows an undefined exposition time of the eye.

The positioning lasers are used to adjust the exact working distance to the corneal

surface. Their output is 50 - 100 µW. As the beams are aimed in a angle to the eye,

an influence at the retina is impossible.

Warnings Laser beam

The laser emits high-performance beams:

Wave lengths: 193 nm

Pulse energy: max. 8 mJ

Energy density: 800 mJ/cm2

Laser beams with these data are potentially dangerous, but in our case, possible

danger is minimised through some details:

•the beam diverges after passing the ablation area, so only in this area a high

energy density exists.

•the beams are partially absorbed in the air

•the cornea does not reflect beam during treatment

These effects reduce the energy density of the beam quickly with growing distance to

the working area, which is about 280 mm under the beam output opening. In spite of

this, the following warnings have to be followed for a safety use:

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• Never look into the laser beam!

• Never put your skin into the laser beam!

• Wear protection glasses

• Make sure, that no reflection devices are placed in the area of the

laserbeam

• Follow the instructions of the trade association VBG 93!

• Persons, not used with the lasers, have to be informed about possible

risks!

Alarm Shields and Type Shield

Beam output is marked with laser warning signs..1.2. Warnschilder

They are looking as following:

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Accessible Beam Area

The beam area of the device is horizontal down from the output opening to the next

surface. Normally this is the patient bed or, in case of treatment, the patient eye.

Diameter of beam at the output opening is app. 1,0 mm. In the treatment area, which

is 290 mm under the output opening, the beam has a diameter of 1,0 mm. Output

and energy density of beam decreases accordingly with increasing distance from

treatment area.

Protection Glasses

All persons inside the room (except the patient) have to wear protection glasses

according to DIN EN 207, when the laser is working. These glasses must have

protection level 7 for beams of 193 nm. The operating surgeon can put-off the

glasses, when he looks through the microscope. The glass optics of the microscopes

weaken the laserbeam, so that the necessary protection level is achieved. Protection

level of glasses depends on maximum existing middle output density (at max. pulse

following frequency) or the maximal energy density. These values are 5 x 102 J/m2.

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Working Gas

Danger through the working gas (fluoride 0.106 %, argon 3.33 % and neon 96.56 %)

has not to be feared.

The laser head contains only a small quantity of fluoride. It is checked according to

the pressure containment regulations. An unintentional output of working gas is very

unlikely. Fluoride can be recognised through its pungent smell, long before the

concentration will come to maximum allowed values for working places. In such

case, open the window, leave the room and call service department of your

distributor or directly

Gas containment:

Pressure gas bottle with working gas is stored inside a gas containment. This gas

containment is airtight and has a filter, which would absorb the fluoride in case of a

leak. For service demands, there is a pressure gas bottle with helium, stored inside

the gas containment too.

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Declaration of Manufacturer (MPG)

The device has been developed according to the Medical Device Regulations MPG.

The named TÜV-office Munich mark: 0123 manufacturer Co. Herbert Schwind

GmbH is allowed to produce laser devices for medicine purposes and to put them

into circulation.

Conformity with the construction authorisation of the device according to the

MPBetreibV is ensured under the precondition, that

• delivery is done through SCHWIND or authorised distributor

• all service and maintenance works are only performed through authorised

personnel

• accessories, consumables and disposable are only allowed, if a completely

harmless use (safety-technique) is confirmed through a test of this device

performed by an authorised testing authority. This is especially important for

patient bed.

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2. Description

Specification

Working Laser ArF-Excimer-Laser

• Wavelength 193 nm

• Power (average, beam output) 2 W max.

• Mode pulsed

• Pulse energy (beam output) 15 mJ max.

• Pulse frequency 200 Hz max.

• Pulse duration 8 ns

• Pulse-to-pulse stability < 5 %

• Power density <1,5 x 105W/m2

• Energy density 800 mJ/cm2

• Beam diameter (output) 7 x 4 mm

• Treatment area app. 280 mm under beam output

• Beam diameter (treatment area) 1.0 mm max.

• Beam divergence 2 x 1 mrad

Pilotlaser Diodelaser

• Wavelength 635 nm

• Power (middle, beam output) < 100 µW

• Mode continued

Fixationlaser Diodelaser

• Wavelength 650 nm

• Power (average, beam output) < 10 µW

• Mode pulsed

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