Users Manual
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SHARPLAN 1041S CO2 SURGICAL LASER SYSTEM U
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Notes: System and accessory specifications subject to change without notice. Manual Catalog No. PB2395300 Manual Version "L" Prepared June, 2004
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Copyright © 2004, the Lumenis group of companies. All rights reserved. Lumenis, its logo and Sharplan are trademarks or registered trademarks of the Lumenis group of companies. All rights reserved. No part of this manual may be reproduced or copied in any form by any means - graphic, electronic or mechanical, including photocopying, typing, or information retrieval systems - without written permission of Lumenis.
Use of Manual: The SHARPLAN 1041S laser system is designed to meet international safety and performance standards. Personnel operating the unit must have a thorough understanding of the proper operation of the system. This manual has been prepared to aid medical and technical personnel to understand and operate the system. Do not operate the system before reading this manual and gaining a clear understanding of the operation of the system. If any part of this manual is not clear, please contact your Lumenis representative for clarification. The information provided in this manual is not intended to replace the physician training or professional training on the clinical use of CO2 lasers. Such training should include a review of published literature, seminars, laser workshops and appropriate preceptorships. Please contact your Lumenis representative for current information on available training. For Professional Information and Clinical Applications, also refer to Appendix C & D of this manual. This manual should always accompany the unit, and its location must be known to all personnel operating the unit. Additional copies of this manual are available at cost price from your Lumenis distributor.
Regulatory European Representative: Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich Germany
Manufactured by Lumenis Ltd. P.O.B. 240 Yokneam 20692, Israel
SHARPLAN 1041S
TABLE OF CONTENTS Chapter 1
Operating Safety Precautions
1.1.
General ... 1-1
1.2.
Burn Hazard ... 1-1
1.3.
Reflection and Direct Eye Exposure Hazard... 1-1
1.4.
Safety Eyewear... 1-2
1.5.
Laser Beam Safety ... 1-2
1.6.
Page
Patient Safety ... 1-2
1.7.
Explosion and Fire Hazard... 1-2
1.8.
High Voltage Hazard... 1-2
1.9.
Using the Proper Power Receptacle & Plug... 1-3
1.10.
Grounding the Unit ... 1-3
1.11.
Fuse Replacement ... 1-3
1.12.
Compliance with International Standards ... 1-4
1.13.
Warning, Certification and Identification Labels... 1-4
Chapter 2
Installation
2.1.
Unpacking and Inspection... 2-1
2.2.
Equipment List ... 2-1
2.3.
Space Requirements ... 2-2
2.4.
Line Power Considerations ... 2-3
2.5.
Remote Interlock System Connection... 2-3
2.6.
Footswitch Connection Assembly... 2-5
2.7.
Installation of Bacteriological Filter ... 2-5
2.8.
Connection to Regulated External Inert Gas Supply ... 2-6
2.9.
Connection to Smoke Evacuation System for Endoscopic Procedures... 2-7
Page
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SHARPLAN 1041S
Chapter 3
System Description
Page
3.1.
General Laser Theory... 3-1
3.2.
Intended Use of Sharplan CO2 Lasers and Accessories... 3-2
3.3.
CO2 Laser Theory ... 3-2
3.4.
General System Description... 3-2
3.5.
Main Cabinet... 3-4
3.5.1.
General ... 3-4
3.5.2.
Optical Bench Assembly... 3-4
3.5.3.
Power Supply ... 3-4
3.5.4.
Laser Cooling System ... 3-4
3.5.5.
Electronic Control Module... 3-4
3.5.6.
Compressed Air/Inert Gas Flow System... 3-5
3.5.7.
Footswitch Compartment ... 3-5
3.5.8.
Service Panel... 3-5
3.6.
Periscope Assembly ... 3-5
3.7.
Articulated Arm Beam Delivery System... 3-7
3.8.
System Modes of Operation... 3-7
3.8.1.
Basic Concepts and Definitions ... 3-8
3.8.2.
Laser Operation Modes ... 3-10
3.8.3.
Tissue Exposure Modes ... 3-13
Chapter 4
Controls, Indicators and Connections
4.1.
General ... 4-1
4.2.
Periscope and Articulated Arm ... 4-1
4.3.
Main Cabinet... 4-4
4.3.1.
Control Panel... 4-4
4.3.1.1.
Keyswitch and Power-On Indicator... 4-5
4.3.1.2.
STBY, OFF/RST and READY Keys...4-6
4.3.1.3.
Column Keys...4-6
4.3.1.4.
Diode Aiming Beam Mode Keys...4-6
4.3.1.5.
Laser Operation Mode Keys...4-7
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SHARPLAN 1041S
4.3.1.6.
Tissue Exposure Mode Keys...4-7
4.3.1.7.
Set Keys...4-7
4.3.1.8.
Numeric Keyboard and ENTER Keys...4-8
4.3.1.9.
Displays...4-8
4.3.2.
Service Panel ... 4-9
Chapter 5
Operating Instructions
Page
5.1.
General... 5-1
5.2.
Preparing the Unit for Operation ... 5-1
5.3.
Turn-On Procedure ... 5-3
5.4.
Checking for Proper Beam Alignment... 5-4
5.5.
Checking and Adjusting Compressed Air/Inert Gas Flow Rate ... 5-4
5.6.
Operating the System... 5-5
5.6.1.
Laser Operation Mode Selection ... 5-5
5.6.2.
Power Setting... 5-5
5.6.3.
Tissue Exposure Mode Selection... 5-7
5.6.4.
Time Selection ... 5-7
5.6.5.
Footswitch Operation... 5-9
5.6.6.
Pause in Operation ... 5-10
5.7.
Fault Messages... 5-11
5.8.
User Codes ... 5-11
5.9.
Programming the System ... 5-13
5.9.1.
Storing A Program ... 5-13
5.9.2.
Recalling A Program ... 5-15
5.10.
Turn-Off Procedure... 5-16
5.11.
Operating Procedures Summary ... 5-17
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SHARPLAN 1041S
Chapter 6
Laser Surgical Accessories
Page
6.1.
General... 6-1
6.2.
Handpiece Set ... 6-1
6.2.1.
Description... 6-1
6.2.2.
Assembly ... 6-2
6.2.3.
Optical Checks... 6-3
6.2.4.
Cleaning, Disinfection, Sterilization and Storage... 6-4
6.3.
Optional Accessories ... 6-5
6.3.1.
SHARPLAN Handpieces... 6-5
6.3.2.
Flexible Fibers ... 6-5
6.3.3.
SHARPLAN Microslads... 6-6
6.3.3.1.
General Description...6-6
6.3.3.2.
Acuspot 712...6-6
6.3.3.3.
Microslad 719...6-7
6.3.3.4.
Other SHARPLAN Microslads...6-9
6.3.4.
SHARPLAN Colposlads and Laser Colposcope ... ...6-9
6.3.5.
SHARPLAN Endoscopes and Auxiliary Endoscopic Devices... 6-10
6.3.6.
SHARPLAN SilkTouch... 6-10
6.3.7.
SHARPLAN SilkLaser ... 6-11
6.3.8.
SHARPLAN SurgiTouch 773 and 774... 6-11
6.3.9.
SHARPLAN Multi Specialty SurgiTouch... 6-12
Chapter 7
Maintenance
7.1.
Introduction... 7-1
7.2.
Service Information ... 7-1
7.3.
Routine Maintenance ... 7-1
7.4.
Fuse Replacement ... 7-3
7.5.
Power Meter Calibration Check/Procedure ... 7-3
7.5.1.
Calibration Check ... 7-3
7.5.2.
Calibration Procedure ... 7-4
7.6.
External Cleaning/Disinfection... 7-6
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SHARPLAN 1041S
7.7.
Lens and Mirror Cleaning... 7-7
7.8.
Moving the Unit... 7-7
Chapter 8
Troubleshooting
8.1.
General... 8-1
8.2.
Troubleshooting Guide ... 8-1
Chapter 9
Specifications
9.1.
Outputs... 9-1
9.2.
Inputs ... 9-2
9.3.
Operation and Control... 9-2
9.4.
Physical... 9-3
9.5.
Standard Accessories ... 9-4
9.6.
Optional Accessories ... 9-4
9.7.
Maintenance Accessories... 9-6
Appendix A
SHARPLAN 1041S Laser Unit Operation and safety Checklist
A.1.
General...A-1
A.2.
Intra-Operative...A-4
A.3.
Post-Operative...A-5
Appendix B
SHARPLAN 750 Remote Control Unit - Operating Instructions
B.1.
Operating Safety Precautions...B-1
B.2.
Unpacking ...B-1
B.3.
Unit Description...B-2
B.3.1.
General...B-2
B.3.2.
Controls and Indicators...B-2
B.4.
Operating Instructions...B-5
Page
Page
Page
Page
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SHARPLAN 1041S
B.4.1.
Installation ...B-5
B.4.2.
Turn-On ...B-5
B.4.3.
Laser Operation Mode selection ...B-6
B.4.4.
Power Setting...B-6
B.4.5.
Tissue Exposure Mode Selection...B-6
B.4.6.
Time Selection ...B-7
B.4.7.
Footswitch Operation...B-8
B.4.8.
Pause in Operation ...B-8
B.4.9.
Turn-Off...B-9
B.4.10
Operating Procedures Summary ...B-9
B.5.
Cleaning and Disinfection...B-10
B.6.
Maintenance...B-11
B.7.
Troubleshooting ...B-11
Appendix C
Professional Information
C.1.
Introduction...C-1
C.2.
Physician Training ...C-2
C.3.
General Surgical Characteristics of CO2 Lasers...C-2
C.3.1.
Pulsed Modes...C-4
C.3.2.
Beam Manipulation...C-5
C.3.3.
Delivery System and Laser Accessories ...C-6
C.4.
General Directions for Use ...C-6
C.5.
General Warnings ...C-6
C.5.1.
Eyewear ...C-6
C.5.2.
Tissue Effects...C-6
C.5.3.
Fire...C-7
C.5.4.
Smoke Evacuation ...C-7
C.5.5.
Direction of Laser Beam...C-7
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SHARPLAN 1041S
Appendix D
Clinical Applications
Page
D.1.
Introduction...D-1
D.2.
Otolaryngology-General ...D-1
D.2.1.
Indications...D-1
D.2.2.
Contraindications ...D-1
D.2.3.
Specific Precautions and Recommendations ...D-1
D.2.4.
Complications ...D-2
D.2.5.
References...D-2
D.3.
Laser Assisted Uvulopalatoplasty (LAUP)...D-4
D.3.1.
Indications...D-4
D.3.2.
Directions for Use...D-4
D.3.3.
Laser Delivery Systems ...D-5
D.3.4.
Contraindications ...D-6
D.3.5.
Specific Precautions and Recommendations ...D-6
D.3.6.
Complications ...D-7
D.3.7.
References...D-8
D.4.
Laser Assisted Myringotomy/Tympanostomy...D-9
D.4.1.
Indications...D-9
D.4.2.
Contraindications ...D-9
D.4.3.
Specific Precautions, Recommendations and Warnings...D-9
D.4.4.
Complications and Side Effects ...D-10
D.4.5.
References...D-10
D.5.
Dermatology/Plastic Surgery ...D-11
D.5.1.
Indications...D-11
D.5.2.
Contraindications ...D-11
D.5.3.
Specific Precautions, Recommendations and Warnings...D-11
D.5.4.
Complications and Side Effects ...D-12
D.5.5.
References...D-12
D.6.
Gynecology...D-13
D.6.1.
Indications...D-13
D.6.2.
Contraindications ...D-13
D.6.3.
Specific Precautions and Recommendations ...D-13
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SHARPLAN 1041S
D.6.4.
Complications ...D-14
D.6.5.
References...D-14
D.7.
Neurosurgery ...D-15
D.7.1.
Indications...D-15
D.7.2.
Contraindications ...D-15
D.7.3.
Specific Precautions and Recommendations ...D-15
D.7.4.
Complications ...D-16
D.7.5.
References...D-16
D.8.
Orthopedics ...D-16
D.8.1.
Indications...D-16
D.8.2.
Contraindications ...D-16
D.8.3.
Directions for Use...D-16
D.8.4.
Specific Precautions and Recommendations ...D-16
D.8.5.
Complications ...D-17
D.8.6.
References...D-17
D.9
General/Thoracic Surgery ...D-18
D.9.1.
Indications...D-18
D.9.2.
Contraindications ...D-18
D.9.3.
Specific Precautions, Recommendations and Warnings...D-18
D.9.4.
Complications ...D-18
D.9.5.
References...D-18
D.10.
Dentistry...D-19
D.10.1.
Indications...D-19
D.10.2.
Contraindications ...D-19
D.10.3.
Specific Precautions, Recommendations and Warnings...D-19
D.10.4.
Complications ...D-19
D.10.5.
References...D-19
D.11.
Podiatry...D-20
D.11.1.
Indications...D-20
D.11.2.
Contraindications ...D-20
D.11.3.
Specific Precautions, Recommendations and Warnings...D-20
D.11.4.
Complications ...D-20
D.11.5.
References...D-20
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SHARPLAN 1041S
D.12
Genito-Urinary...D-21
D.12.1.
Indications...D-21
D.12.2.
Contraindications ...D-21
D.12.3.
Specific Precautions, Recommendations and Warnings...D-21
D.12.4.
Complications ...D-21
D.12.5.
References...D-21
ix
SHARPLAN 1041S
Figure 1. SHARPLAN 1041S Laser System
x
CHAPTER 1 Operating Safety Precautions and Compliance with International Standards
1.1. General
The SHARPLAN 1041S CO2 surgical laser system is specially designed to minimize accidental exposure to hazardous radiation. Caution • Use of controls or adjustments, or performance of procedures other than those specified herein may result in hazardous radiation exposure. Therefore, personnel operating the SHARPLAN system must be thoroughly familiar with all of its safety requirements and operating procedures. • Improper use or adjustment of this system may invalidate the SHARPLAN service warranty agreement. Please contact your SHARPLAN representative before attempting to use this system in any manner other than as specified in this manual. The areas of concern for safe CO2 laser operation are discussed in this chapter.
1.2. Burn Hazard
CO2 laser radiation is invisible to the human eye and can cause third-degree burns, even when unfocused.
1.3. Reflection and Direct Eye Exposure Hazard
The system output beam contains visible and invisible laser radiation that is hazardous to the eye. Never stare into the CO2 laser beam or allow it to be reflected from any reflecting surface – even rough metal can reflect the CO2 laser beam. As a precaution against accidental exposure to the output beam or to its reflections, all personnel must wear safety eyewear. Never stare directly into the diode aiming beam. Also ensure that the aiming beam is not directed at anyone's eyes. Although this beam is low powered, direct exposure can be hazardous to eyes.
1-1
Operating Safety Precautions
1.4. Safety Eyewear
Sharplan 1041S
All personnel in the vicinity of the laser unit must wear safety eyewear, and must ascertain that the eyewear provides adequate protection from the 10.6 micron wavelength radiation. This is generally provided by most quality safety glass spectacles with side guards for protection from lateral exposure. The American Optical spectacle-type safety glasses, or equivalent, provide ample protection. Safety eyewear is not required when viewing through a microscope, colposcope or an endoscope, as the glass lenses provide sufficient protection.
1.5. Laser Beam Safety
• Do not point the articulated arm or the laser aiming beam at any part of the
body. • Do not point the articulated arm or the laser aiming beam at any reflective surface such as mirrors, jewelry, watches, and surgical instruments. • Do not point the articulated arm or the laser aiming beam at any flammable
or explosive materials or liquids.
1.6. Patient Safety
For enhanced patient safety, perform the following safety procedures: 1. Surround the surgical area with wet towels. 2. Make sure that safety eyewear is available to the patient, if conscious. For facial surgery, completely cover the patient's eyes with moistened eye pads.
1.7. Explosion and Fire Hazard
Do not operate the unit in the presence of flammable anesthetics or volatile substances such as alcohol, gasoline or solvents. Flammable drapes, surgical gowns, gauze and other ignitable materials must be kept out of the beam path. The use of nonflammable materials and instruments is advised. Flame retardant surgical drapes, gowns, etc., are recommended. A readily accessible fire extinguisher in the vicinity of the unit is also recommended.
1.8. High Voltage Hazard
The SHARPLAN 1041S unit generates high voltages within the main cabinet. To avoid injury, do not operate the unit before ensuring that all its panels are properly closed. Do not attempt to remove or disassemble any panels. SHARPLAN-authorized technical personnel only may service the unit.
1-2
SHARPLAN 1041S
1.9. Using the Proper Power Receptacle and Plug
Operating Safety Precautions
Use only a power receptacle and plug that are in good condition, and that are specified for your unit. Use only a hospital grade plug and a correctly matched power receptacle. The wiring instructions are noted on the hospital grade connection label attached to the power cord (see 1.11). To remove the power cord from the receptacle, hold it by the plug. Never pull the power cord to remove the plug from the receptacle.
1.10. Grounding the Unit
The unit is grounded through the grounding conductor in the power cord. Good grounding is essential for safe operation. To ensure grounding reliability, always plug the power cord into a properly wired hospital grade power receptacle. Additional grounding can be provided by using the external ground connection point (see 2.4).
1.11. Fuse Replacement
The operator may replace the fuses on the service panel only (see Figure 4-5, item 51). Access to fuses inside the main cabinet is limited to SHARPLAN-authorized technical personnel only. To avoid fire hazard, use only the fuses specified for your unit. Replacement fuses must be identical in type, voltage rating and current rating to the original fuses. Fuse type is LITTLEFUSE No.212 slow-blow, or equivalent. For exact fuse rating, refer to the fuse listing on the service panel. Note The fuse originally labeled as 3A may be replaced by a slow-blow fuse rated for 3.15A. Warning Before removing a fuse, turn off the keyswitch, remove the power cord from the power receptacle and wait approximately two minutes to allow high voltage discharge.
1-3
Operating Safety Precautions
1.12. Compliance with International Standards
Sharplan 1041S
The SHARPLAN 1041S laser unit complies with: • US Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV laser products • European Directive 93/42/EEC Concerning Medical Devices (Annex II) • European Directive 89/336/EEC Concerning Electromagnetic Compatibility
1.13. Warning, Certification and Identification Labels
Figure 1-1 shows the location of the important labels affixed to the unit. These include: 1. Laser Emission Danger Label – warning against possible exposure to laser radiation and specifying the types of lasers present (Location: main cabinet front panel, upper left-hand corner): A - on systems in Europe B - on systems in the USA 2. Non-interlocked danger label – warning against possible radiation exposure when laser enclosure is opened. (Location: periscope inner metal cover, visible upon removal of periscope outer plastic cover) 3. Laser aperture warning label – indicating laser beam exit location. (Location: articulated endjoint) 4. Certification label – manufacturer and/or distributor details. (Location: on inside of service panel access door) 5. Identification label – noting unit model number, serial number, electrical requirements and date of manufacture. (Location: on inside of service panel access door) 6. Fuses warning label – warning that replacement fuses must be identical in type and rating to the original fuses, and specifying fuse types. (Location: on inside of service panel access door) 7. Class I, type B label – indicating that the unit meets class I type B requirements, as defined in IEC 601.1 and UL 544 Standards for electrical protection. (Location: inside of service panel access door) 8. Protective earth label – indicating the location of the external ground connection point. (Location: service panel) 9. High voltage danger label – warning against the high voltage within the unit. (Location: service panel)
1-4
SHARPLAN 1041S
Operating Safety Precautions
10. Hospital grade connection label – indicating that only a hospital grade plug should be connected to the power cable, and providing the wiring instructions for the plug. (Location: affixed to power cable) 11. Risk of explosion or fire label – warning against risk of explosion or fire if used in the presence of flammable anesthetics or materials. (Location: main cabinet front panel, below the laser emission danger label.) 12. Electric shock warning label – warns user to properly ground the unit, and against opening the unit's cover.
Figure 1-1. Warning, Certification and Identification Labels
1-5
CHAPTER 2 Installation
2.1. Unpacking and Inspection
The SHARPLAN 1041S unit has passed full quality assurance testing before shipment. Thus, the unit should be operational upon delivery. The unit may be unpacked, installed and tested only by a SHARPLANauthorized technician. No attempt should be made by the purchaser to unpack or assemble the unit. Note Any damage to the container or to the unit found prior to opening the container or during unpacking, installation or testing of the unit should be immediately reported to your SHARPLAN distributor.
2.2. Equipment List
The SHARPLAN 1041S system includes the following: 1. SHARPLAN 1041S laser unit 2. 125mm handpiece set 3. Footswitch (in footswitch compartment) 4. Remote interlock connector assembly (installed) 5. Set of master keys 6. Spare fuses (X5) 7. Disposable bacteriological filter (X5) 8. Adapter for suction/inert gas hoses (X3) 9. Laser radiation warning sign 10. User's Manual.
2-1
Installation
2.3. Space Requirements
SHARPLAN 1041S
The working area for the SHARPLAN 1041S unit should be prepared according to the dimensions shown in Figures 2-1 and 2-2. The length of the unit's power cable is 3.5m. The unit should be positioned at least 50cm (20") from the wall (or other obstructions to air flow) to guarantee adequate ventilation. After the unit is properly positioned, press the brake pedal (see Figure 4-1, item 14) to lock the wheels of the unit.
Figure 2-1. Dimensional Drawing – Side View
2-2