WaveLight Allegretto Wave Eye-Q User manual

ALLEGRETTO WAVE EYE-Q

User Manual

This User Manual ALLEGRETTO WAVE EYE-Q is valid as from Firmware Version PR- V4-1.02 (see chapter 5.3 “Turning On The System” from page 37) and Notebook Portal Software Version 2.020 (see chapter 5.6.19 “Notebook Software Info” on page 127).

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Typographical Conventions

TYPOGRAPHICAL CONVENTIONS

The following conventions and symbols are used in this manual:

WARNING

A Warning alerts the user to potential serious outcomes to the patient or user in case of non observance of this warning.

CAUTION

Precautions alert the reader to exercise special care necessary for the safe and effective use of the device.

NOTE

Notes provide helpful or supplementary information to the user.

Further Typographical Conventions:

In addition to the aforementioned, the following conventions are used in this User Manual.

KEYBOARD Here you have to enter or edit items in the menu.

MOUSE Move mouse or click mouse button.

ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

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General Warnings And Precautions

GENERAL WARNINGS AND PRECAUTIONS

WARNING

This laser workstation and its accessories can cause flammable materials to ignite or explode.

CAUTION

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

This manual is copyrighted with all rights reserved. Under copyright laws this manual may not be reproduced or transmitted in whole or in part in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from WaveLight AG.

Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes also translation into other languages.

Please note that while every effort has been made to ensure that the data given in this manual are accurate, the information, figures, illustration, tables, specifications and schematics contained herein are subject to change without notice.

All images are representative. The numbers shown in the images are just examples and may not represent typical values. Some sections of this manual may not apply for all devices. Such sections will be marked accordingly. Other manuals may apply as well for use of the device described herein.

ALLEGRETTO WAVE® EYE-Q is a registered trademark of WaveLight AG. Wavefront Optimized™ is a registered trademark of WaveLight AG. Custom Q® is a registered trademark of WaveLight AG.

PerfectPulse Technology® is a registered trademark of WaveLight AG. Right.From the Start.® is a registered trademark of WaveLight AG. Zeiss and OPMI are registered trademarks of Carl Zeiss.

Microsoft, Windows™ 2000 is a registered trademark of Microsoft Corporation.

© Copyright by WaveLight AG, Germany All Rights reserved

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Contents

CONTENTS

			Page
1.	INTRODUCTION...............................................................................................		11
2.	GENERAL NOTICES TO USERS ....................................................................		12
3.	SAFETY INSTRUCTIONS ................................................................................		13
	3.1.	Eye Protection ....................................................................................	15
	3.2.	Safety Against Fluorine and Ozone....................................................	16
	3.3.	Patient Safety .....................................................................................	17
	3.4.	Use Restrictions .................................................................................	19
	3.5.	Safety Design .....................................................................................	22
4.	SYSTEM DESCRIPTION..................................................................................		23
	4.1.	System Overview ...............................................................................	23
	4.2.	Lighting...............................................................................................	24
	4.3.	Switching Elements And Interfaces ....................................................	25
5.	FUNCTIONAL DESCRIPTION .........................................................................		35
	5.1.	Important Steps Before Turning On The System................................	35
	5.2.	Structure Of The ALLEGRETTO WAVE EYE-Q Firmware.................	36
	5.3.	Turning On The System .....................................................................	37
	5.3.1.	Logfile Option .....................................................................................	38
	5.3.2.	Self Test .............................................................................................	41

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	Contents
		Page
5.4.	System Check ....................................................................................	42
5.4.1.	General Information About The System Check ..................................	42
5.4.2.	Check Of Nitrogen-Gas Pressure And Beam Path Flushing ..............	43
5.4.3.	ArF-Premix-Gas Pressure ..................................................................	45
5.4.4.	Laser Head Pressure..........................................................................	47
5.4.5.	Check And Calibration Of The Internal Laser Energy.........................	50
5.4.6.	Eyetracker Test ..................................................................................	61
5.4.7.	Fluence Test.......................................................................................	62
5.5.	Treatment Direct Entry Without Notebook ..........................................	63
5.5.1.	Nomogram..........................................................................................	64
5.5.2.	Entering Treatment Data ....................................................................	65
5.6.	Navigation And Data Entry With The Notebook Portal Software ........	69
5.6.1.	Starting The Notebook Program.........................................................	71
5.6.2.	How To Perform A Wavefront Optimized Treatment ..........................	72
5.6.3.	Examination Data Range Wavefront Optimized .................................	92
5.6.4.	Treatment Data Range Wavefront Optimized.....................................	93
5.6.5.	Printout ...............................................................................................	94
5.6.6.	Screenshot .........................................................................................	95

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Contents
		Page
5.6.7.	How To Perform a PTK Treatment .....................................................	96
5.6.8.	Treatment Data Range PTK.............................................................	109
5.6.9.	Import Data.......................................................................................	110
5.6.10.	Setting Menu ....................................................................................	118
5.6.11.	How To Change The Language And The Date/Time Format ...........	119
5.6.12.	How to Set The Timer ......................................................................	120
5.6.13.	Enter Default Settings ......................................................................	121
5.6.14.	Treatment Counter ...........................................................................	123
5.6.15.	Connect To Service Center ..............................................................	126
5.6.16.	Browse Customer Info......................................................................	126
5.6.17.	Recreate Data-Files .........................................................................	126
5.6.18.	Service .............................................................................................	127
5.6.19.	Notebook Software Info....................................................................	127
5.6.20.	Shutdown The Program ...................................................................	128
5.7.	Positioning The Patient ....................................................................	129
5.8.	Checking The Eyetracker Function ..................................................	130
5.9.	Hints For Keratectomy......................................................................	132
5.10.	Ready Mode.....................................................................................	133

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		Contents
		Page
5.11.	Patient’s Eye Alignment, Fixation And Centering	.............................134
5.12.	Starting Laser Treatment..................................................................	136
5.13.	Interrupting Treatment ......................................................................	138
5.14.	Aborting Treatment...........................................................................	139
5.15.	Finishing Treatment..........................................................................	139
5.16.	Setup Menu ......................................................................................	140
5.16.1.	General Settings “Next Page”...........................................................	142
5.16.2.	Fluence Test.....................................................................................	143
5.16.3.	ET-Test.............................................................................................	143
5.16.4.	Gas Change ArF...............................................................................	144
5.16.5.	Scanner Test ....................................................................................	144
5.16.6.	Micrometer Test................................................................................	144
5.16.7.	External Energy Check.....................................................................	144
5.16.8.	Definition Center Of Ablation ............................................................	145
5.16.9.	LCD Contrast....................................................................................	148
5.16.10.	Brightness Setting Distance Diodes .................................................	149
5.16.11.	Brightness Setting Aiming Beam ......................................................	150
5.16.12.	Vertex Distance ................................................................................	151
5.16.13.	Setting Flat K....................................................................................	151

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Contents

			Page
	5.17.	Routine Test Procedures With The Control Systems	.......................152
	5.17.1.	The Calibration Tool Kit....................................................................	154
	5.17.2.	Check Of The Eyetracker Function ..................................................	155
	5.17.3.	Eyetracker Test And Calibration Procedure .....................................	156
	5.17.4.	Test Of Eyetracker Centering ...........................................................	164
	5.17.5.	Fluence Test And Calibration Procedure..........................................	165
	5.17.6.	Ablation Depth Normal Glass Standard............................................	177
	5.17.7.	Scanner Test ....................................................................................	180
	5.17.8.	Scanner Test Procedure ..................................................................	180
	5.18.	Turning Off .......................................................................................	184
6.	ACCESSORIES ..............................................................................................		186
	6.1.	Patient Bed.......................................................................................	187
	6.2.	Video Adapter...................................................................................	187
	6.3.	Notebook..........................................................................................	187
7.	CARE OF DEVICE AND ACCESSORIES......................................................		188
8.	ERRORS AND HOW TO FIX..........................................................................		189
9.	LIST OF MESSAGES AND WARNINGS .......................................................		198

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			Contents
			Page
10.	TECHNICAL ASSISTANCE ...........................................................................		210
	10.1.	Service Hotline .................................................................................	210
	10.2.	Maintenance.....................................................................................	211
	10.3.	Technical Safety Inspection..............................................................	212
	10.4.	Disposal............................................................................................	213
11.	LABELING......................................................................................................		214
	11.1. Labeling Of The Laser Unit...............................................................		214
	11.2. Labeling Of The Ablation Depth Micrometer.....................................		219
	11.3. Labeling Of The Test Adapter ..........................................................		220
	11.4. Labeling Of The Laser Area .............................................................		221
12.	TECHNICAL DATA.........................................................................................		222
	12.1.	Device Data......................................................................................	222
	12.2.	Electromagnetic Compatibility ..........................................................	225
13.	WARRANTY ...................................................................................................		230
14.	LIST OF ACCESSORY PRODUCTS..............................................................		231

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Introduction

1.INTRODUCTION

Intended Use:

The ALLEGRETTO WAVE EYE-Q is a scanning-spot excimer laser system used in refractive surgery for LASIK (Laser In-Situ Keratomileusis) treatments.

The uniqueness of the system consists in a combination of technologically refined features, including a compact excimer laser with leading edge high pulse frequency, a galvanometer scanner for positioning the laser spot and a fast eyetracker for determining eye position and laser-beam direction. The Gaussian-shaped beam profile of the individual pulses and an ablation diameter of approximately 1 mm assure the desired contour and minimize surface irregularities during ablation.

In addition to the photorefractive Wavefront Optimized applications (myopia with or without astigmatism, hyperopia with or without astigmatism), this attribute in combination with the open system concept enables also the usage of patient related, individual corrections. These corrections could e.g. be based on topography or wavefront data.

A further advantage of the small spot diameter is that the ALLEGRETTO WAVE EYE-Q requires the use of only minimal pulse energy. The result is a compact excimer laser beam source with minimal gas volume and minimal gas consumption. As the excimer laser is operated at a high repetition frequency, short treatment times are assured. The integrated eyetracker offers unique automatic centering of the ablation and tracking of even rapid eye movements. With the ALLEGRETTO WAVE EYE-Q the user is provided with a medical device featuring maximum control and safety thus offering the patient highest customer satisfaction.

If you have any questions, please call:

Am Wolfsmantel 5

91058 Erlangen, Germany

Hotline

Tel: + 49 1805 / 52 62 62

Fax: + 49 9131 / 6186 -221

E-Mail Service: [e-mail] E-Mail Application: [e-mail]

ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

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General Notices To Users

2.GENERAL NOTICES TO USERS

CAUTION

As with every technologically sophisticated medical device, the use of this laser system requires special training and skills. The laser may only be used by specially trained physicians who are well versed in its therapeutic effects and possible dangers and who possess the necessary skills to use it in conformity with the operating instructions contained in this User Manual.

The ALLEGRETTO WAVE EYE-Q laser is a medical device currently designed for use according to its intended use as described in this User Manual. Applications other than those described in this User Manual are prohibited and are the exclusive responsibility of the operator.

This User Manual refers only to operation, maintenance and care of the device. All treatment data in the figures are given as example values.

In this User Manual modifications are described which are valid for firmware version PR-V4-1.02 and notebook software version 2.020 or later.

The use of mobile telephones or similar appliances is not allowed while the device is working.

On account of the possible risk of interference from electromagnetic radiation while the ALLEGRETTO WAVE EYE-Q laser system is in operation, persons with heart pacemakers may not be present in the room.

The effect of electromagnetic radiation of the device on embryos or pregnant women has not been specifically studied. However, the device fulfils the international electromagnetic safety standard DIN EN 60601-1-2. Local laws and regulations beyond this safety standard in regards to pregnant women in the vicinity of the device during start-up, stand-by or operation must be followed.

Should the laser system or any accessory require service, please do not attempt to perform service yourself. Only WaveLight AG authorized service technicians or service technicians who have been specifically authorized by WaveLight AG are allowed to service the ALLEGRETTO WAVE EYE-Q laser system. Servicing or any kind of manipulation of the system, by non-authorized personnel will result in a termination of the warranty and a nullification of any liability on the part of WaveLight AG.

There exist no rightful claims to system upgrades upon the introduction of product improvements based on new technological developments.

Always use original packaging for returns.

WaveLight AG will help you for the waste disposal of the device. (see chapter 10.4 “Disposal” on page 213).

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Safety Instructions

3.SAFETY INSTRUCTIONS

CAUTION

It is absolutely necessary to read this User Manual carefully before using the ALLEGRETTO WAVE EYE-Q laser system.

Please also refer to the User Manuals of other accessories and equipment that are used in conjunction with the ALLEGRETTO WAVE EYE-Q laser system.

National regulations for installing and operating medical products and medical lasers respectively have to be taken into consideration.

The ALLEGRETTO WAVE EYE-Q laser device is an active medical device of class IIb according to the Medical Device Directive 93/42/EEC.

Any laser can cause physical harm if used improperly.

The ALLEGRETTO WAVE EYE-Q contains a class 4 laser.

Please remember that reflective materials or instruments can deflect the laser beam haphazardly. Special attention must be paid to glass surfaces. Similarly, high-gloss polished metal surfaces within a few meters of the laser can cause dangerous laser irradiation.

Prescribed laser protective goggles must be worn in case of laser emission in the laser area.

Except for therapeutic purpose, never look directly at the laser beam.

If the laser beam is deployed for medical purposes, the user is responsible for making sure that accompanying optical devices for observation or adjustment are outfitted with appropriate protective filters of the adequate protection class.

During operation the so called laser area must be delineated and identified according to DIN EN 60825-1.

The gas cylinders must be transported separately from the laser.

Perform a visual inspection of the ALLEGRETTO WAVE EYE-Q laser system housing before every use.

The laser device must not be operated if the LCD screen of the laser console is defective. The menu structure is interactive. Do not proceed when the LCD screen is dark or when visibility (contrast) is inadequate for clear visualization.

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Safety Instructions

The operator has to ensure that protective measures against fire and explosion risks are taken in the medical application of laser radiation in the region of organs, body cavities and tubes which can contain combustible gases or vapors.

In the event of fire or strong development of smoke in the treatment room, the emergency-stop button of the laser system has to be actuated and treatment has to be interrupted immediately. All persons in the treatment room are asked to leave the room without delay and fire-extinguishing measures have to be taken.

According to the German Medical Device Law, medical devices may be installed, operated and used only in accordance with the purpose for which they were designed, and only in accordance with the stipulations of the Medical Device Law (including any associated legal codes), accepted technological regulations, worker-safety regulations and accident prevention regulations. Medical devices may not be operated and used, if they exhibit any defects through which the health and safety of patients, employees or other persons could be endangered. The devices may be operated and used only by persons who, due to their training or to their knowledge and practical skills, can offer assurance of proper device operation.

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Safety Instructions

3.1.Eye Protection

Due to the high energy density levels (Fluence) involved, the eye is especially at risk of injury from laser beams. The eye can incur injury even at low levels of irradiation.

Protection from laser irradiation has two components:

1.Protection of the patient through the proper operation of the laser device by the physician and

2.Protection of all involved persons, including the physician, from unintended beam emissions.

CAUTION

Protective goggles must be worn while in the laser area. Not observance can lead to irreversible eye injury.

Make sure that the laser protection goggles are in perfect condition before use!

The protective glasses must not show any signs of mechanical damage. The below prescribed type has to be used.

The protective goggles for use with the ALLEGRETTO WAVE EYE-Q laser system must meet the following minimum standards:

IR 193 nm L3 (according to DIN EN 207)

Type of Laser

IR = Impulse Laser

Wavelength at which the

Protective goggles offer Protection.

Protection Grade

For the purpose of safety verification, the protective goggles must be marked as indicated above.

CAUTION

Never look directly at the laser beam.

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Safety Instructions

3.2.Safety Against Fluorine and Ozone

When contemplating the potential risk from toxic gases you have to consider Fluorine.

Fluorine:

WARNING

The ALLEGRETTO WAVE EYE-Q is outfitted with a filter system, which prevents toxic gas from passing out. In case gas odor (fluorine) is detected, the following steps must be taken:

•Close the ArF-Premix-gas cylinder valve.

•Open all windows in the vicinity of the laser in order to ensure adequate ventilation and - if available - switch on room ventilation, given that the ventilation does not spread the gas in other rooms.

•Leave the room and lock the door so that nobody can enter the room.

•Call your WaveLight AG authorized service technician or local distributor.

The ALLEGRETTO WAVE EYE-Q checks for system gas leaks as soon as it is turned on. The following precautionary measures should be taken when the machine is turned off:

•Keep the ArF-Premix-gas cylinders closed when the machine is turned off.

•Follow the system instructions when changing the gas, i.e., whenever opening and closing the ArF-Premix-gas cylinders.

Fluorine is part of the “Premix” gas mixture necessary for running the excimer laser. Fluorine is an extremely reactive and highly toxic gas that can cause serious chemical and toxic irritations. It can even, in sufficiently high concentrations, lead to death due to respiratory failure. It distinguishes itself through an extremely piercing odor that can be detected by nose at a concentration below that of the maximum permissible workplace concentration of 0.1 ppm.

In case the Premix is inadvertently released into the room air, the user must avoid exposure for periods longer than those permitted according to local safety regulations.

A further potential chemical hazard occurs in the formation of hydrofluoric acid, which occurs if the fluorine comes into contact with water.

Ozone:

A further potential danger consists in the formation of ozone, which arises from the interaction of oxygen and either ultraviolet radiation or high voltage. Ozone can also be detected by its pungent odor and is not critical at concentrations of < 0.1 ppm. Purging the beam path with Nitrogen-gas (N2) reduces the formation of ozone in the laser system.

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Safety Instructions

3.3.Patient Safety

In case of evident signs of erroneous data or system malfunction no treatments must be carried out to avoid irreversible injuries to the patient. The ALLEGRETTO WAVE EYE-Q laser system and accessories may only be operated by persons who have been trained in its use and are capable of ensuring proper operation.

Precautionary measures are to be taken in the handling and use of all accessories, disposable articles and agents that come into contact with the patient so that exposure to pathogens can be avoided (see chapter 7 “Care Of Device And Accessories” from page 188).

After turning on the ALLEGRETTO WAVE EYE-Q carefully go through the System Check procedure and note the results in the Archive Folder (see chapter 5.4 “System Check” from page 42 and chapter 5.17 “Routine Test Procedures With The Control Systems” from page 152). Consult your nearest authorized WaveLight AG dealer or the ALLEGRETTO WAVE EYE-Q service center in case you have any questions regarding this matter.

Follow carefully the system comments displayed on the LCD and notebook screen. Pay careful attention especially to messages informing you about laser pulse energy settings and the amount of gas in the cylinders. Consult your nearest authorized WaveLight AG dealer or the ALLEGRETTO WAVE EYE-Q service center in case you have any questions regarding this matter.

Make sure that the entered patient and treatment data coincide with the correct eye of the patient. Also be sure that the correct Vertex Distance is entered in the “Setup Menu” of the ALLEGRETTO WAVE EYE-Q.

The user is responsible for validating and cross checking of the data during the steps between measurement and treatment. Please perform and note carefully all diagnostic and other clinical findings of the patient's eye prior to the laser treatment.

Especially crosscheck the subjective refraction data with the data displayed on the ALLEGRO Analyzer, ALLEGRO Topolyzer, ALLEGRO Oculyzer as well as on the F-CAT System software. This data must not differ significantly.

Also check differences between maximum ablation depths between Wavefront Optimized, PTK, A-CAT, Topo-guided and F-CAT treatments.

The ALLEGRETTO WAVE EYE-Q light sources, especially the illumination for the operation microscope, are designed to enable optimal treatment by the user. In order to avoid unnecessary discomfort for the patient, the lighting should be switched on for as short a time as possible.

The laser treatment should take place in a quiet and relaxed atmosphere in order not to distract the attention of the patient. The patient should lie in the middle of the bed, the head should rest comfortably on the headrest. Make sure that nobody bumps against the bed during the procedure of the laser treatment.

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Safety Instructions

When positioning or moving the patient bed or other moving parts, please make sure that patients, system operators and other personnel cannot be squeezed or pinched.

To avoid possible skin irritations of the patient, all areas of the patient bed coming into direct contact with the patient shall be covered with paper.

Do not perform a treatment if any component is broken.

The use of any component not validated for use with the ALLEGRETTO WAVE EYE-Q laser system is not permitted and is the sole and exclusive responsibility of the user.

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Safety Instructions

3.4.Use Restrictions

CAUTION

The laser device ALLEGRETTO WAVE EYE-Q has been tested according to

DIN EN 60601-1-2 (EMC) (see chapter 12.2 “Electromagnetic Compatibility” on page 225).

Accessories not authorized by WaveLight AG may not be used. The

ALLEGRETTO WAVE EYE-Q laser system may only be operated with the components that are delivered with it or are provided by WaveLight AG. Each component has been inspected and approved for use. See chapter 6 “Accessories” on page 186.

Running any software that has not been approved and released by the manufacturer is not permitted.

The ALLEGRETTO WAVE EYE-Q and its components may not be powered with the use of a multiple or non-fixed outlet.

The ALLEGRETTO WAVE EYE-Q may not be operated in explosion endangered rooms and areas.

The ALLEGRETTO WAVE EYE-Q may only be used in designated medical rooms in accordance to the international standards.

Do not connect the ALLEGRETTO WAVE EYE-Q with non-medical electrical equipment (e.g. data processing devices) for purposes of creating an electro medical system if this will result in a safety level for the patient which is below that specified by DIN EN 60601- 1 standard. If permissible levels for leakage currents are exceeded due to such connections, appropriate safety measures, including a disconnecting device, must be present.

Any auxiliary equipment connected to the analog or digital interfaces of this unit must be certified as meeting applicable EN and/or IEC-specifications. In addition, all configurations must fulfill DIN EN 60601-1 and DIN EN 60601-1-1 standard for electromedical systems.

The USB-stick must only be used for WaveLight AG units and must meet the criteria listed in table 22 “Data Communication” on page 223. The USB-stick must not be removed during treatment.

Always disconnect the electric plugs of the ALLEGRETTO WAVE EYE-Q and all units connected to it, e.g., plume evacuator, from their power sources before carrying out maintenance or cleaning work.

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Safety Instructions

The device has been tested for electromagnetic conformity (EMC). Despite adherence to all applicable EMC requirements, malfunctioning cannot be ruled out entirely. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

•Reorient or relocate the receiving device.

•Increase the space between the devices.

•Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.

Do not exert strong force to connect electrical plugs and sockets. If it is not possible to connect them, check whether the plug is correct for the socket. If you find damage in either a plug or a socket, have them repaired by our service personnel. To disconnect electric plugs from their sockets, do not pull on the cable, but rather on the plug itself.

Do not use the units contained in the standard equipment list

•in places where there is danger of explosion,

•in the presence of combustible anesthetics or volatile solvents such as alcohol, benzine or the like.

Do not store or use the unit in damp rooms. Avoid placing the unit near dripping, or splashing water, and make certain that no liquids can enter the unit. For this reason, please do not place any containers of liquid on top of the unit, and also take care when cleaning the unit with a damp cloth that no liquid gets into the unit. Please refer to chapter 7 “Care Of Device And Accessories” on page 188.

Do not cover the air vents.

The ALLEGRETTO WAVE EYE-Q laser system may only be operated in rooms which can be adequately ventilated (≥ 100 m³/h), ≥ 3500 feet³/h respectively). The volume of the room must be ≥ 75 m³, ≥ 2650 feet³ respectively. However, room ventilation must be switched off during treatments.

The ALLEGRETTO WAVE EYE-Q laser system may not be operated above an altitude of 2000 m (6560 feet) above sea-level, below room temperature of + 18°C (+ 64.4°F) and above room temperature of + 30°C (+ 86°F). The humidity values must be 20% to 70% at + 25°C (+ 77°F), not condensing. Avoid the vicinity of heating units and humidity both during use of the instrument and when it is stored. The optic components in the unit may become covered by condensation if you store the unit in a cold room or in a vehicle during the cold part of the year or if there are wide changes from cold to warm in the ambient temperature. Please give the unit time to acclimatize to its new surroundings before using it for the first time. Please refer to chapter 12 “Technical Data” on page 222.

Please use the designated on-off switch for turning off the device.

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

Safety Instructions

Make sure that the patient remains calm and relaxed during the treatment and that the patient is able to concentrate on the fixation light, otherwise the treatment result could be unsatisfactory.

Ask your WaveLight AG service center to check the ALLEGRETTO WAVE EYE-Q if the system was exposed to any type of shock that could have caused a misalignment of the optical pathway. A safety check is necessary after any type of shock before any further treatments are performed. Misalignment after a shock exposure could result in nonsatisfactory treatments.

ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

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Safety Instructions

3.5.Safety Design

General specifications and standards relevant to design and manufacturing practices and procedures, such as those delineated in DIN EN 60601 and DIN EN 60825, were adhered to in the design and manufacture of the ALLEGRETTO WAVE EYE-Q laser system.

Additional protective measures designed into the system offer a high degree of safety and operating comfort.

•The microprocessor unit conducts a Self Test after the laser is switched on. If the test indicates an error, the device shuts off automatically after a time span of

10 minutes.

•After successfully completing the internal Self Test the System Check is carried out.

•The user is actively involved into the System Check and should protocol the test results.

•If the tests indicate no errors, the laser switches to “Standby Mode”. The user can repeat all main test procedures in between the treatments.

•The microprocessor monitors many sensors and displays messages and alerts if necessary.

•The adjusted laser and treatment parameters are checked cyclically and shown on the LCD screen of the laser console.

•The ArF-Premix-gas cylinder must be re-closed after every procedural step in which ArF-Premix-gas is required.

•The laser system is equipped with a remote interlock connector that can be connected to the door of the treatment room so that the laser will stop firing if the door is opened during a treatment (see chapter 4.3 “Switching Elements And Interfaces”, figure 5 “Elements On The Rear Side Of The Device” on page 27).

•The ALLEGRETTO WAVE EYE-Q laser is a stable, stationary device that should not be moved by the user.

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

System Description

4.SYSTEM DESCRIPTION

4.1.System Overview

Eyetracker Monitor

Notebook

Operation Microscope

Ablation Depth

Micrometer

Optics Arm

LED Slit Illumination

System

Patient Bed (Pivoting optional)

Laser Aperture

LCD Screen

Control Panel

Laser Pedal

Center Pedal

ALLEGRETTO WAVE EYE-Q

Laser Console

Figure 1: ALLEGRETTO WAVE EYE-Q Laser System (With Optional Accessories)

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Page 23 of 232

System Description

4.2.Lighting

Plume Evacuation Air Intake

Eyetracker LED's For

“Neuro Track”

Red Continuous Distance

Diodes

Green Flashing Fixation Light, AND Cross Line Projector

(concealed)

Red Aiming Beam

Eyetracker Illumination (Infrared Light)

Microscope Illumination (White Light)

Figure 2: Integrated Radiation Sources

Figure 2 gives an overview of the integrated radiation sources.

Two superimposing red diode laser beams (distance diodes) define the treatment plane at the intersection point of the two diodes.

In addition a green, flashing LED serves as a fixation target for the patient. It is coaxial to the optical axis. The patients can see this target only in a small area based on the viewing angle.

A cross line projector enables the alignment of the patient’s head.

The beam axis of the aiming beam laser diode is coaxial to the excimer beam axis and used as the centering check.

The infrared lighting is necessary for the function of the eyetracker. The infrared lighting arrays are mounted on a lever that can be turned for comfortable preparation of the eye.

Special white light emitting LED arrays are integrated for the illumination of the eye. They are responsible for the bright, high contrast picture of the operation microscope.

A plume evacuator can be used to remove the ablation debris (option).

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

System Description

4.3.Switching Elements And Interfaces

System Main Switch:

All components of the ALLEGRETTO WAVE EYE-Q laser system that require mains voltage are powered from the Mains Distribution Box.

The System Main Switch on the Mains Distribution Box controls all system power. The switch is lit when it is switched on.

Components typically powered from the Mains Distribution Box:

•Laser Console

•Eyetracker Monitor

•Patient Bed

•LED Slit Illumination System

•Notebook Computer

The Mains Distribution Box is located between laser console and patient bed. It must only be opened by authorized service personnel.

System Main Switch

Mains Distribution Box

Figure 3: Mains Distribution Box With System Main Switch

ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

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System Description

Emergency Laser Emission

Stop Switch

Key Switch

1 2 3

Figure 4: Key Switch And Emergency Laser Emission Stop Switch On The Front Of The Device

Key Switch:

The Key Switch is for turning the laser device on and off. The key can also be removed to prevent unauthorized system use. It has three positions:

1 = OFF

2 = ON

3 = START

Emergency Laser Emission Stop Switch:

The Emergency Laser Emission Stop Switch allows the laser system to immediately shut down the laser emission in case of an emergency so that any injuries to persons or damages to the device can be avoided through reaction of the user. Pressing the Emergency Laser Emission Stop Switch does not disconnect the device from the mains supply. Pressing the red button activates the switch. The button must be released before the laser can be turned on again by turning the red knob clockwise.

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

System Description

I O

ArF-Gas Valve

Handle

N2 -Gas Valve

Handle

Main Power Cable Outlet

Main Power Switch

Removable Cover To Gas

Cylinder Compartment

Interface Opt. Video System

Interface ET Monitor

Interface Notebook

Remote Interlock Connector

Foot Pedal Unit Outlet

Patient Bed Outlet

Figure 5: Elements On The Rear Side Of The Device

Main Power Cable Outlet:

The power cord is firmly attached to the laser device and comes fitted with a plug.

Main Power Switch:

The Main Power Switch is used for turning on the laser device. After switching ON (position I) the Main Power Switch the device is operational and can be activated via the Key Switch.

Notebook Interface:

Via this standard interface and with the use of a special program provided by WaveLight AG, the ALLEGRETTO WAVE EYE-Q can be operated via notebook.

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Page 27 of 232

System Description

Remote Interlock Connector:

An external contact can be plugged into the remote interlock connector to interrupt the laser treatment if the laser room door is opened during treatment. If no external contact is used, the remote interlock plug that is delivered with the laser device should be plugged into the remote interlock connector outlet.

NOTE

If neither an external contact nor a remote interlock plug is plugged in, the laser device will not operate. The following message will appear on the display: “Door Contact”.

Foot Pedal Unit:

The foot pedal unit consists of two pedals:

Laser Foot Pedal:	The left pedal, the LASER foot pedal (LASER pedal), controls
	the emission of the laser during treatment. It is fitted with a
	bow guard to prevent activating the laser unintentionally.
	Pressing this pedal starts the treatment. To interrupt the
	treatment, lift your foot off the pedal. The treatment can be
	continued by activating the LASER foot pedal again.

Center Test Foot Pedal: The right pedal is the CENTER Test foot pedal (CENTER pedal). This pedal serves to check the centering of the ablation.

LASER Pedal

CENTER Pedal

Figure 6: LASER Foot Pedal And CENTER Test Foot Pedal

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

System Description

Patient Bed:

The patient is brought into proper position via the patient bed control unit. Precise information on adjusting the bed can be found in the patient bed User Manual. Since the ALLEGRETTO WAVE EYE-Q automatically switches off the power to the bed during laser emission for safety reasons, the patient bed cannot be moved during treatment.

NOTE

Because of this safety-switching feature, the patient bed can only be moved when the ALLEGRETTO WAVE EYE-Q is turned on.

In case of collision hazard between eyetracker illumination and patient head, the patient bed power is switched off automatically, if the patient’s head touches the eyetracker illumination assembly.

LCD Screen:

Instructions for the user as well as important laser and application parameters are indicated on the LCD screen of the laser console.

SYSTEM CHECK

Instruction and

Information Lines

ArF

Figure 7: Display Instructions

Notification

For example the system is in System Check.

General Indication Status notifications

Symbols

For example a gas cylinder symbol.

ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001

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	System Description
Control Panel With Joystick:
Gas Key	OK Key
	Joystick
Not Used	Not Used
Eyetracker	Eyetracker Key
Adjustment	ON / OFF
	Cross Line Key
Cross Line	ON / OFF
Brightness
	Aiming Beam Key
Microscope	ON / OFF
Illumination	Setup Key
Brightness
	Distance Diodes
	ON / OFF
	Ready Key
Figure 8: Control Panel With Joystick

The control panel consists of a foil keypad with integrated LED's, control knobs and a joystick (positions: up / down, left / right)

The joystick serves the purpose of confirming routines as well as selecting parameters during the “System Check”, “Setup Menu” and furthermore during “Treatment Mode”. By pressing a foil key, general functions will be carried out or continued.

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ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001