Operators Manual
90 Pages
Preview
Page 1
SELECTA DUET Nd:YAG Ophthalmic Laser System Operator’s Manual
This Operator’s Manual describes the operation of the Model Selecta Duet Nd:YAG laser. Every effort has been made to ensure that the information in this manual is accurate, but the information, illustrations, tables, drawings and specifications contained in the document are subject to change without notice. If you have any questions or encounter difficulties do not hesitate to contact the following, or your local distributor as appropriate: Product Manager Lumenis Inc. 2400 Condensa Street SANTA CLARA, CA 95051-0901 USA Tel: Main: (408) 764-3000 Service: (800) 367-7899 Fax: (408) 764-3990
EU Authorized Representative Lumenis (Germany) GmbH Dieselstrasse 5c D-64807 Dieburg Germany Tel: +49 6071 922 0 Fax: +49 6071 922 400
This product was designed and manufactured in Australia by Ellex Medical Pty. Ltd.
93/42/EEC 0805
Terms used in this Operator’s Manual and which are known, or suspected, to be trademarks are listed below. Use of a term in this Operator’s Manual should not be regarded as affecting the validity of any trademark or service mark. Lumenis is a registered trademark of Lumenis Inc. USA. Laserex and Total Access are registered trademarks of Ellex Medical Pty Ltd, Australia.
This Operator’s Manual is Lumenis Part No: 0642-265-01, Revision A Ellex Part No: 8432006, Issue 1.0 Copyright © 2003, Ellex Medical Pty Ltd.
This Operator’s Manual contains confidential and proprietary information of Ellex Medical Pty Ltd and may not be reproduced in whole or part without their written approval.
Cautions Use of controls or adjustments, or performance of procedures other than those specified herein may result in hazardous radiation exposure. When using the YAG treatment laser, use caution in assessing patients who have glass intraocular lenses (IOL) implanted. Treatment of such patients with pulsed Nd:YAG lasers can result in cracked or pitted glass IOLs. Posterior capsulotomies are contraindicated for such patients, except for those whose medical condition precludes invasive surgery. Special care is also necessary for patients who have plastic IOLs. If laser treatment is selected, use low energies and extreme care. This laser system should be used only by qualified physicians fully trained in using these instruments. This instrument generates a highly concentrated light beam that can cause injury if incorrectly used. We therefore strongly recommend that you read and understand this Operator’s Manual in its entirety before using the product. If you have any questions about this laser system, please contact your local Lumenis representative.
CONTENTS
ABOUT THIS OPERATOR’S MANUAL ... V Conventions ... vi CHAPTER 1 INTRODUCTION ... 1-1 1.1 Overview ...1-1 CHAPTER 2 SAFETY ... 2-1 2.1 Safety classification and warnings...2-2 2.2 Safety features of the Selecta Duet ...2-5 2.3 Safety labels ...2-9 2.4 Operational safety precautions ... 2-11 CHAPTER 3 INDICATIONS FOR USE ... 3-1 3.1 YAG treatment laser - theory of clinical use ...3-1 3.2 SLT treatment laser - theory of clinical use ... 3-11 CHAPTER 4 INSTRUMENT DESCRIPTION ... 4-1 4.1 YAG treatment beam...4-3 4.2 SLT treatment beam ...4-3 4.3 Laser system...4-4 4.4 Power supply console...4-4 4.5 Table and stand ...4-4 4.6 Control module controls and indicators...4-5 4.7 Other controls and features ...4-8 4.8 Laser head-controls and features... 4-11 4.9 Slit lamp-controls and features... 4-12 4.10 Technical specifications... 4-15
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
i
Contents
CHAPTER 5 OPERATION ... 5-1 5.1 Starting the Selecta Duet ...5-1 5.2 Emergency Laser Stop ...5-3 5.3 Normal shut down...5-3 5.4 Operating the Selecta Duet ...5-3 5.5 Moving the instrument ...5-9 CHAPTER 6 MAINTENANCE ... 6-1 6.1 Preventive maintenance...6-1 6.2 Routine maintenance...6-1 6.3 Cleaning and disinfection ...6-3 6.4 Error codes ...6-9 6.5 Troubleshooting ...6-9 6.6 Verification and calibration procedure... 6-11 6.7 Transportation ... 6-11 6.8 Product lifetime... 6-12 6.9 Product disposal... 6-12 6.10 Warranty information ... 6-13 APPENDIX A INSTALLATION...A-1 A1 List of contents ... A-1 APPENDIX B DECONTAMINATION CERTIFICATE ... B-1 APPENDIX C ERROR CODES...C-1
LIST
OF
ILLUSTRATIONS
Figure 1–1:
Overview of the Selecta Duet ...1-2
Figure 2–1:
Safety label locations ...2-9
Figure 4–1:
Location of laser aperture...4-2
Figure 4–2:
Control module...4-5
Figure 4–3:
LCD indications...4-7
Figure 4–4:
Power supply console controls & features ...4-8
Figure 4–5:
Console connections ... 4-10
ii
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
Contents
Figure 4–6:
Laser head ... 4-11
Figure 4–7:
Slit lamp ... 4-13
Figure 6–1:
Alignment target in position...6-5
Figure 6–2:
Checking aiming accuracy ...6-6
Figure A–1:
Shipping carton label ... A-2
LIST
OF
TABLES
Table 2–1:
Safety features ...2-6
Table 2–2:
Additional safety features ...2-7
Table 2–3:
Description of safety labels ... 2-10
Table 4–1:
Control module controls and indicators ...4-6
Table 4–2:
LCD indications...4-7
Table 4–3:
Console switches and adjustments ...4-9
Table 4–4:
Chin rest adjustments ...4-9
Table 4–5:
Console connectors ... 4-10
Table 4–6:
Laser head controls ... 4-12
Table 4–7:
Slit lamp controls ... 4-13
Table 4–8:
System specifications... 4-15
Table 4–9:
YAG treatment laser specifications ... 4-16
Table 4–10:
SLT treatment laser specifications... 4-16
Table 4–11:
Aiming lasers specifications... 4-17
Table 4–12:
Slit lamp specifications ... 4-17
Table 4–13:
Accessories part numbers... 4-19
Table 4–14:
Spare parts list ... 4-19
Table 6–1:
Troubleshooting table...6-9
Table 6–2:
Slit lamp troubleshooting table... 6-11
Table 6–3:
Component materials ... 6-13
Table C–1:
Error codes ... C-1
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
iii
Contents
This page is left blank intentionally.
iv
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
ABOUT
THIS
OPERATOR’S MANUAL
This Operator’s Manual describes the use of the Lumenis Selecta Duet Nd:YAG Ophthalmic Laser. It is intended for the use of owners and operators of the instrument. The Operator’s Manual contains the following information:
Caution
⇒
an introduction to the Selecta Duet and an explanation of how it works
⇒
safety information
⇒
instructions for using the instrument
⇒
routine care and maintenance information
⇒
specifications
⇒
appendices containing installation, warranty and calibration information
Before using the instrument for the first time, you should read the safety requirements outlined in Chapter 2, and then become familiar with the controls. These are described in detail in Chapter 4.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
v
About this Operator’s Manual
CONVENTIONS The following symbols and conventions are used: ⇒, →
a list item
, •
an action to take
1.
a step in a procedure requiring many steps
italics
a new term, emphasis, or a cross-reference
Pay particular attention to the information contained within boxes like this one. They contain notes of particular significance to the performance of the instrument.
Caution
vi
Attention to information in boxes like this is necessary to avoid situations that could cause injury or equipment failure.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
CHAPTER 1
INTRODUCTION
1.1
OVERVIEW This Operator’s Manual describes the use of the Lumenis Selecta Duet Nd:YAG laser, which is an instrument intended for use only by licensed ophthalmologists. The Selecta Duet incorporates two treatment modes: ⇒
⇒
YAG photodisruptor mode - for carrying out: →
posterior capsulotomy
→
iridotomy
→
posterior membranectomy
→
other procedures that use photodisruption
SLT mode - for carrying out: →
selective laser trabeculoplasty (SLT)
Before using the instrument for the first time, read the safety requirements outlined in Chapter 2, then become familiar with the controls described in Chapter 4. The Selecta Duet is illustrated in Figure 1-1.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
1-1
Introduction
Figure 1–1: Binocular head
Overview of the Selecta Duet
Magnification changer
Slit lamp
Chinrest
Laser head
Control module
Table
Stand column
Stand base (a wheelchair accessible base is also available)
Joystick/fire switch Power supply console
1-2
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
CHAPTER 2
SAFETY
The Lumenis Selecta Duet is a very safe instrument when used correctly. As with other laser surgical equipment the Selecta Duet is capable of causing injury if not used in accordance with the correct safety procedures and operating instructions. Caution
We strongly recommend that you read and understand this Chapter and Chapter 4 before using the instrument for the first time.
US Federal Law restricts this device to sale by, or on the order of, a physician.
Caution
This instrument is capable of producing focused high intensity visible and invisible light. Uncontrolled or unintentional exposure of human tissue to the treatment beam should be avoided.
Caution
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.
Caution
Never substitute prescription glasses for safety eyewear as the glass in such spectacles can concentrate laser light onto the retina. The glass may also be shattered by a high density beam, resulting in possible severe eye injury.
Caution
When not in use, protect the instrument from unauthorized use by removing the key from the system power key switch.
Caution
The Selecta Duet can be operated in either YAG or SLT modes. Always check the correct mode is selected before use. Eye damage may result from use of the incorrect treatment mode.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
2-1
Safety
2.1
SAFETY CLASSIFICATION AND WARNINGS The Selecta Duet is classified as a Class IIIb/3B laser product and a Class I Type B electrical protection product. It has been manufactured to be in compliance with the following standards: ⇒
IEC 60601-1; 1988, Electrical Safety Standard for Medical Equipment
⇒
IEC 60601-2-22; 1995, Requirements for Safety of Diagnostic/Therapeutic Equipment
⇒
IEC 60825-1; 1993, Safety of Laser Products, part 1.
⇒
USA Code of Federal Regulation 21CFR 800 - 1299
⇒
EN 601-1-2:2001, Electromagnetic compatibility
The following laser safety warnings apply to users.
2.1.1 Caution
Eye protection Visible or invisible laser radiation is emitted from the delivery system when it is in laser READY status and the fire button is pressed. Do not look into the YAG or SLT treatment beam. The operator is protected from hazard while in the normal operating position because the instrument is fitted with protective filters.
Caution
Check the safety filters regularly for any imperfections in the coated surface. Deterioration of the coating causes the SLT treatment beam to appear as green light. If either of these conditions arises do not use the instrument. Contact your Lumenis Distributor. Appropriate safety glasses should be available outside the room for all people requiring access (see Section 2.1.2 and 2.1.3). Any viewing ports or windows to the room must be covered. Safety interlocks and warning lamps may be fitted to the room. Avoid using reflective instruments and it is recommended that all surfaces in the room be matt finish to prevent possible reflection of the laser.
2-2
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
Safety
2.1.2 Caution
YAG laser emission warning (1064 nm) Class 3B/IIIb Laser Product: avoid direct exposure to beam.
Viewing through all slit lamp optical accessories including camera adaptors and coobservation tubes is safe for the viewing eye because the built-in filter provides protection. Protection at an OD of at least 5 @ 1064 nm must be provided for the eye that is not directly viewing through the accessory. All other persons attending the procedure (except the patient being treated) must wear safety glasses, goggles or masks designed to prevent transmission of 1064 nm wavelength laser light (optical density (OD) 5 @ 1064 nm). Safety glasses or safety filters providing protection from other wavelengths may not offer any protection from 1064 nm wavelength and should not be used. For users who must comply with EN207, the safety eyewear must have a protection class of L5.
2.1.3 Caution
SLT treatment beam emission warning (532 nm) Class 3B/IIIb Laser Product: avoid direct exposure to beam.
The operator is protected from hazard while in the normal operating position because the instrument is fitted with protective infrared absorption filters. All other persons attending the procedure (except the patient being treated) must wear safety glasses, goggles or masks designed to prevent transmission of 532 nm wavelength laser light (optical density (OD) 5 @ 532 nm). Viewing through all slit lamp optical accessories including camera adaptors and coobservation tubes is safe for the viewing eye because the built-in filter provides protection. Protection at an OD of at least 5 @ 532 nm must be provided for the eye that is not directly viewing through the accessory. Safety glasses or safety filters providing protection from other wavelengths may not offer any protection from 532nm wavelength and should not be used. For users who must comply with EN207, the safety eyewear must have a protection class of L5.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
2-3
Safety
2.1.4 Caution
Aiming laser emission warning (635 nanometer) The aiming laser used in the Selecta Duet is a 635 nm Class II/2 Laser. Visible laser radiation is emitted from the delivery system when it is switched on and is in the STANDBY or READY status. Do not stare into the aiming beam unless under the control of a qualified ophthalmic surgeon. Use the lowest practical aiming beam intensity and minimum required exposure time. The aiming beams are red diode lasers with a wavelength of 635 nm. It is a Class II/2 laser with power less than 0.95 milliwatts (mW). “Class II/2 lasers are not intrinsically safe but eye protection is normally afforded by aversion responses including the blink reflex”. (Quoted from IEC 60825-1: 1993.) Damage to the retina from the aiming beam is most improbable, but it is still advisable to avoid staring into the beam unless under controlled conditions. Regularly check the aiming beam spot shape to ensure good optical alignment and no fiber damage. Do not fire the treatment laser if the aiming beam is not present.
2.1.5 Caution
2.1.6 Caution
2-4
Reflection warning Objects that reflect visible light will reflect 1064 or 532 nm laser light. Avoid placing reflective materials such as glass, metal and polished plastic in the laser beam path.
Explosion hazard warning The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided. Some materials, for example cotton wool when saturated with oxygen may be ignited by the high temperatures produced in NORMAL USE of the LASER EQUIPMENT. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the LASER EQUIPMENT is used. Attention should also be drawn to the danger of ignition of endogenous gases.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
Safety
2.1.7 Caution
2.1.8
Electromagnetic compatibility This device may be affected by external RF sources (such as mobile phones) in the vicinity during operation.
Safety signs Safety signs should be displayed warning of Class IIIb/3B Laser and Class IIb/2B in operation.
2.2
SAFETY FEATURES OF THE SELECTA DUET The Selecta Duet includes a number of safety features provided in accordance with the requirements of the appropriate standards. The Selecta Duet also includes a number of additional safety features, which are listed in Section 2.2.2.
2.2.1
Features relating to standards The Selecta Duet is designed and built to comply with the following standards:
Electrical and laser product standards ⇒
IEC 60601-1; 1988 - Electrical Safety Standard for Medical Equipment (encompasses AS3200.1; 1990)
⇒
IEC 60601-2-22; 1995 - Requirements for Safety of Diagnostic/Therapeutic Equipment
⇒
IEC 60825-1; 2001 - Safety of Laser Products, part 1.
⇒
21CFR 1040.10, 21CFR 1040.11; 2001 - USA Code of Federal Regulation
⇒
Australian Standard AS/NZS2500:1995 - Guide to the Safe Use of Electricity in Patient Care
⇒
Australian Standard AS/NZS2211:1997 - Laser Safety
Manufacturing standards ⇒
93/42/EEC for CE Marking
⇒
United States Code Of Federal Regulations Title 21 part 820 - a Quality System Regulation
⇒
ISO 9001:1994/EN 46001:1996 - Quality Management System
The safety features provided in accordance with these standards include those described in the following table.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
2-5
Safety
Table 2–1:
2-6
Safety features
Feature
Description
Lockable key switch
The lasers can only be turned on with the correct key. The key cannot be removed while in the ON position, so the laser cannot operate without the key in place.
Emergency Laser Stop switch
During normal operation this red mushroom shaped push button is in the ON position (out). When pressed in it immediately switches off all power and eliminates any risk of laser irradiation. The button must be released by turning clockwise to the ON position to restart the system and return to STANDBY status.
Laser Selection Button
Once the power is turned on with the key switch, the Emergency Laser Stop switch is in the ON position, and the interlock is closed (where applicable), the treatment mode can be selected by pressing the YAG/SLT button. An illuminated symbol appears beneath the selected mode name.
Laser READY/ STANDBY indicator
Once the power is turned on with the key switch, the Emergency Laser Stop switch is in the ON position, the interlock closed (where applicable), the control display is illuminated and the green console power indicator glows. After completing power-up diagnostic tests the yellow standby indicator on the control module glows, and the last used treatment mode is indicated. READY/STANDBY can now be selected by pressing the Ready/Standby button. If the system is in READY status when this button is pressed, it reverts to STANDBY status. When READY status is selected the standby indicator is turned off and a red indicator is turned on. The system must be manually switched to laser READY status before the treatment laser will fire. Note: There is a delay of two seconds after READY is selected before the laser can be fired.
Safety remote interlock
This is a user-installed feature and is highly recommended. A connector is provided on the console bottom for connection to a door interlock switch, which prevents the laser from firing when the door is opened. The unit is supplied fitted with a bypass plug.
Safety shutter
Each laser and optical system module is equipped with a spring loaded safety shutter that keeps the treatment laser optical path blocked unless the system is manually switched in READY status, the treatment laser is selected and the laser fire switch is pressed.
Excess energy detection
The system shuts down if more than double the set energy is delivered.
Energy deviation warning
The system warns the operator if delivered energy deviates more than ±20% from the set value.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
Safety
Feature
Description
Protective housings
Protective housings on the laser and optical system, as well as the control and display systems, prevent the operator from being inadvertently exposed to laser emission or high voltage shock. The protective housings cannot be removed without tools and must only be opened by authorized service personnel.
Location of controls
All the operator controls are located so that there is no risk to the operator of inadvertent laser exposure.
Ocular filters
The operator viewing port on the laser and optical system module contains a safety filter to limit the exposure level to the operator's eyes to below class 1 limits. Any standard slit lamp viewing accessory can be used with the Selecta Duet slit lamp without hazard.
FDA and IEC compliance labels
Locations and illustrations of the safety compliance labels are contained in the safety labels section.
Electrical leakage protection
A medical grade power supply is built into the power supply console. This ensures that the complete instrument including the slit lamp power supply meets the requirements of IEC 601-1 for earth leakage protection.
2.2.2
Additional safety features The Selecta Duet is equipped with safety features in addition to the mandatory requirements specified by IEC and FDA:
Table 2–2:
Additional safety features
Feature
Description
Memory test
When the Selecta Duet is first switched on the system automatically checks the microprocessor memory. If a malfunction is detected an error code is displayed and the laser cannot be switched into READY status. See Section 6.4 for discussion of the error codes.
Laser power-up test
After the memory test the system automatically performs a self-test program where it confirms the safe and correct operation of the modules. During this procedure the microprocessor fires a series of test shots with the shutter closed. If this test routine is satisfied, the normal operating screen is displayed in the LCD screen on the control module and the energy of the last test shot is displayed. If a malfunction is detected, an error code is displayed and the laser cannot be made to fire. See Section 6.4 for discussion of the error codes. At the end of the self-test routine and initialization process the control module automatically enters the last used treatment mode (YAG or SLT).
Treatment mode
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
2-7
Safety
Feature
Description
STANDBY status
At the end of the self-test routine and initialization process the control module automatically enters STANDBY status. In this state the aiming laser is activated and all the controls function, allowing the treatment mode and settings to be selected. The treatment laser is disabled and the laser fire switch will not function. STANDBY status eliminates the risk of accidental treatment beam activation during patient set up. To enable the treatment laser to function, select laser READY status. Note: There is a delay of two seconds after READY is selected before the laser can be fired.
Shutter monitor
A dual sensor shutter monitor checks the correct opening and closing of the shutter. In the event of a shutter malfunction, the laser fire switch is disabled and an error code is displayed in the LCD screen on the control module. See Section 6.4 for discussion of the error codes.
Automatic test fire
Every time an energy setting is changed, either by the Energy Control or via the selection for the number of pulses, an automatic test fire occurs. During this test fire, the shutter remains closed so there is no risk of exposing the patient or operator to laser radiation. After a test fire, the resultant energy is shown in the LCD screen on the control module.
2-8
Reset after power failure
When power is restored after a power failure, the system will restart and will be in STANDBY status.
Fault conditions
If the system detects a fault during operation, an error code is displayed on the control module LCD. Warnings may be cleared by the operator, while errors result in automatic system shut down. See Section 6.4 for a discussion of error codes.
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
Safety
2.3
SAFETY LABELS In compliance with MDD 93/42/EEC, FDA guidelines and International Standard IEC 60601.1, this section contains a facsimile of every safety label and voltage/power rating label attached to the Selecta Duet.
Figure 2–1:
Safety label locations
Manufactured for
By Ellex Medical Pty. Ltd. 74 to 86 Gilbert Street, Adelaide, S.A. 5000 CAUTION U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON ORDER OF A PHYSICIAN THIS PRODUCT COMPLIES WITH 21 CFR, CHAPTER I, SUBCHAPTER H MADE IN AUSTRALIA U.S. AND INTERNATIONAL PATENTS PENDING
REF SN
AP
IP 20
100-120 V~ 220-240 V~ 50/60 Hz 520VA
LASER CLASS 3B/IIIb Nd:YAG: 1064 nm, 45mJ Max, 4 ns pulse Nd:YAG: 532 nm, 6mJ Max, 3 ns pulse
LASER CLASS 2/II Diode Laser: 635 nm, <1mW Max CW
VISIBLE AND INVISIBLE LASER RADIATION AVOID DIRECT EXPOSURE TO BEAM CLASS 3B LASER PR ODU CT per IEC 60825-1:1993 C LASS IIIb LASER PRODUCT per 21 C FR 1040
Selecta Duet Nd:YAG Ophthalmic Laser Operator's Manual Revision A
2-9