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 PRV4-1.02 (see chapter
Software Version 2.020 (see chapter
5.3 “Turning On The System” from page 37) and Notebook Portal
5.6.19 “Notebook Software Info” on page 127).
Page 2 of 232 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:
A Warning alerts the user to potential serious outcomes to the patient or user
in case of non observance of this warning.
Precautions alert the reader to exercise special care necessary for the safe
and effective use of the device.
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.
WARNING
CAUTION
NOTE
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 3 of 232
General Warnings And Precautions
GENERAL WARNINGS AND PRECAUTIONS
This laser workstation and its accessories can cause flammable materials to
ignite or explode.
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 i n 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 give n 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
Wavefront Optimized™ is a registered trademark of WaveLight AG.
Custom Q® is a registered trademark of WaveLight AG.
PerfectPulse Technology
Right.From the Start.
Zeiss and OPMI are registered trademarks of Carl Zeiss.
Microsoft, Windows™ 2000 is a registered trademark of Microsoft Corporation.
®
EYE-Q is a registered trademark of WaveLight AG.
®
is a registered trademark of WaveLight AG.
®
is a registered trademark of WaveLight AG.
© Copyright by WaveLight AG, Germany
All Rights reserved
WARNING
CAUTION
Page 4 of 232 ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001
Contents
CONTENTS
1. INTRODUCTION...............................................................................................11
Page
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....................................................
5. FUNCTIONAL DESCRIPTION .........................................................................
25
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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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
Contents
Page
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........
5.6.1. Starting The Notebook Program.........................................................
69
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
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
Page
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 .............................................................................................
5.6.19. Notebook Software Info....................................................................
127
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
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 7 of 232
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
Contents
Page
5.16.3. ET-Test.............................................................................................143
5.16.4. Gas Change ArF...............................................................................144
5.16.5. Scanner Test....................................................................................144
5.16.6. Micrometer Test................................................................................
5.16.7. External Energy Check.....................................................................
144
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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Contents
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
Page
5.17.8. Scanner Test Procedure .................................................................. 180
5.18. Turning Off .......................................................................................184
6. ACCESSORIES..............................................................................................186
6.1. Patient Bed .......................................................................................
6.2. Video Adapter...................................................................................
187
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
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 9 of 232
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 ..........................................................
13. WARRANTY ...................................................................................................
14. LIST OF ACCESSORY PRODUCTS ..............................................................
225
230
231
Page 10 of 232 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: ophtha-service@wavelight.com
E-Mail Application: ophtha-applications@wavelight.com
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 11 of 232
General Notices To Users
2. GENERAL NOTICES TO USERS
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.
CAUTION
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
Disposal” on page 213).
“
Page 12 of 232 ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001
10.4
Safety Instructions
3. SAFETY INSTRUCTIONS
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.
CAUTION
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 13 of 232
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.
Page 14 of 232 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.
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:
Type of Laser
IR = Impulse Laser
IR 193 nm L3 (according to DIN EN 207)
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.
Never look directly at the laser beam.
CAUTION
CAUTION
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 15 of 232
Safety Instructions
3.2. Safety Against Fluorine and Ozone
When contemplating the potential risk from toxic gases you have to consider Fluorine.
Fluorine:
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.
WARNING
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 (N
system.
Page 16 of 232 ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001
) reduces the formation of ozone in the laser
2
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
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
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.
7 “Care Of Device And Accessories” from
5.4 “System
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 17 of 232
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.
Page 18 of 232 ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001
Safety Instructions
3.4. Use Restrictions
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
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 606011 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
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.
22 “Data Communication” on page 223. The USB-stick must not be
CAUTION
6 “Accessories” on page 186.
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 19 of 232
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 (
the room must be
≥ 75 m³, ≥ 2650 feet³ respectively. However, room ventilation must be
≥ 100 m³/h), ≥ 3500 feet³/h respectively). The volume of
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
and above room temperature of
+ 30°C (+ 86°F). The humidity values must be 20% to
+ 18°C (+ 64.4°F)
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.
Page 20 of 232 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 Page 21 of 232
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
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.
4.3 “Switching Elements And
Page 22 of 232 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
Figure 1: ALLEGRETTO WAVE EYE-Q Laser System (With Optional Accessories)
Control Panel
Laser Pedal
Center Pedal
ALLEGRETTO WAVE EYE-Q
Laser Console
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 23 of 232
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.
System Description
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).
Page 24 of 232 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.
Figure 3: Mains Distribution Box With System Main Switch
System Main Switch
Mains Distribution Box
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 Page 25 of 232
System Description
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:
Emergency Laser Emission
Stop Switch
Key Switch
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.
Page 26 of 232 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
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.
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
ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001 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.
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.
Figure 6: LASER Foot Pedal And CENTER Test Foot Pedal
NOTE
LASER Pedal
CENTER Pedal
Page 28 of 232 ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001
System Description
A
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.
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
rF
Figure 7: Display Instructions
NOTE
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 Page 29 of 232
System Description
Control Panel With Joystick:
Gas Key
Not Used
Eyetracker
Adjustment
Cross Line
Brightness
Microscope
Illumination
Brightness
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.
OK Key
Joystick
Not Used
Eyetracker Key
ON / OFF
Cross Line Key
ON / OFF
Aiming Beam Key
ON / OFF
Setup Key
Distance Diodes
ON / OFF
Ready Key
Page 30 of 232 ALLEGRETTO WAVE EYE-Q 1010 User Manual en / Rev.9 / 09-06-08 Item No.: 6638 2001
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