SHARPLAN 40C Surgical Laser Users Manual Ver L April 2004

SHARPLAN 40C CO2 SURGICAL LASER SYSTEM U S E R ' S

M A N U A L

Notes: System and accessory specifications subject to change without notice. Manual Catalog No. PB2344000 Manual Version "L" Prepared April, 2004

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 40C 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 A & B 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 40C

Table of Contents

Table of Contents Chapter 1

Operating Safety Precautions and Compliance with International Standards

Page

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. Patient Safety ... 1-2 1.6. Explosion and Fire Hazard... 1-2 1.7. High Voltage Hazard... 1-2 1.8. Using the Proper Power Receptacle and Plug... 1-2 1.9. Grounding the Unit ... 1-3 1.10. Fuse Replacement ... 1-3 1.11. Compliance with International Standards ... 1-3 1.12. Warning, Identification and Certification Labels ... 1-4

Chapter 2

Installation

Page

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 ... 2-5 2.7. Setting the Desired Language on the Message Display... 2-5 2.8. Installation of the Bacteriological Filter ... 2-5

Chapter 3

System Description

Page

3.1. General Laser Theory... 3-1 3.2. CO2 Laser Theory ... 3-1

I

Table of Contents

Sharplan 40C

3.3. General System Description... 3-2 3.4. Main Cabinet... 3-5 3.4.1. General ... 3-5 3.4.2. Optical Bench Assembly... 3-5 3.4.3. Power Supply ... 3-6 3.4.4. Laser Cooling System ... 3-6 3.4.5. Control Panel... 3-7 3.4.6. Air Flow System ... 3-7 3.4.7. Handpiece Set Compartment... 3-7 3.4.8. Footswitch Compartment ... 3-8 3.4.9. Articulated Arm Compartment ... 3-8 3.5. Articulated Arm Beam Delivery System ... 3-8 3.6. System Modes of Operation... 3-9 3.6.1. Basic Concepts and Definitions ... 3-10 3.6.2. Laser Operation Modes... 3-11 3.6.3. Tissue Exposure Modes ... 3-13

Chapter 4

Controls, Indicators and Connections

Page

4.1. General ... 4-1 4.2. Main Cabinet and Articulated Arm... 4-1 4.3. Control Panel... 4-3 4.3.1. Displays... 4-3 4.3.2. Keyswitch and Power-on Indicator... 4-3 4.3.3. STBY, OFF/RST and READY Keys ... 4-4 4.3.4. Tissue Exposure Mode Keys ... 4-4 4.3.5. Laser Operation Mode Keys ... 4-4 4.3.6. POWER and TIME Keys ... 4-5 4.3.7. Programming Keys... 4-6 4.4. Rear Panel ... 4-6

II

Sharplan 40C

Chapter 5

Table of Contents

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. Operating the Unit... 5-5 5.5.1. Laser Operation Mode Selection ... 5-5 5.5.2. Power Setting ... 5-5 5.5.3. Tissue Exposure Mode Selection... 5-6 5.5.4. Time Selection ... 5-7 5.5.5. Footswitch Operation... 5-8 5.5.6. Pause in Operation ... 5-10 5.6. Fault Detection... 5-10 5.7. Programming the Unit... 5-10 5.7.1. Storing a Protocol... 5-10 5.7.2. Recalling a Protocol ... 5-11 5.8. Turn-off Procedure... 5-11 5.9. Preparing the Unit for Transportation/ Storage ... 5-12 5.10. Operating Procedures Summary ... 5-14

Chapter 6

Laser Surgical Accessories

Page

6.1. General ... 6-1 6.2. Handpiece Set ... 6-1 6.2.1. Handpiece Assembly... 6-2 6.2.2. Cleaning, Disinfection, Sterilization and Storage... 6-2 6.3. Optional Accessories ... 6-4 6.3.1. SHARPLAN Handpieces ... 6-4 6.3.2. Flexible Fibers ... 6-4 6.3.3. SHARPLAN Microslads... 6-5 6.3.3.1. General Description ... 6-5 6.3.3.2. Acuspot 712 ... 6-5 6.3.3.3. Microslad 719 ... 6-6

III

Table of Contents

Sharplan 40C

6.3.3.4. Other SHARPLAN Microslads... 6-8 6.3.4. SHARPLAN Colposlads and Laser Colposcope ... 6-9 6.3.5. Lumenis Endoscopes and Auxiliary Endoscopic Devices ... 6-9 6.3.6. SHARPLAN SilkTouch ... 6-10 6.3.7. SHARPLAN SilkLaser ... 6-10 6.3.8. SHARPLAN SurgiTouch... 6-10 6.3.9. SHARPLAN Multi-Specialty SurgiTouch... 6-11 6.3.10. SHARPLAN SureTouch ... 6-12

Chapter 7

Maintenance

Page

7.1. Introduction... 7-1 7.2. Service Information... 7-1 7.3. Routine Maintenance ... 7-1 7.4. Power Meter Calibration Check/Procedure ... 7-3 7.4.1. Power Meter Calibration Check... 7-3 7.4.2. Power Meter Calibration Procedure... 7-4 7.5. Fuse Replacement ... 7-5 7.6. External Cleaning / Disinfection... 7-5 7.7. Lens and Mirror Cleaning... 7-6

Chapter 8

Troubleshooting

Page

8.1. General ... 8-1 8.2. Troubleshooting Guide ... 8-1

Chapter 9

Specifications

Page

9.1. Outputs ... 9-1 9.2. Operation and Control... 9-2 9.3. Inputs... 9-2 9.4. Physical ... 9-3 9.5. Standard Accessories ... 9-3

IV

Sharplan 40C

Table of Contents

9.6. Optional Accessories ... 9-3 9.7. Maintenance Accessories... 9-5

Appendix A

Professional Information

Page

A.1. Introduction ... A-1 A.2. Physician Training ... A-2 A.3. General Surgical Characteristics of CO2 Lasers ... A-2 A.3.1. Pulsed Modes ... A-4 A.3.2. Beam Manipulation... A-5 A.3.3. Delivery System and Laser Accessories ... A-6 A.4. General Directions for Use ... A-6 A.5. General Warnings... A-6 A.5.1. Eyewear... A-6 A.5.2. Tissue Effects ... A-6 A.5.3. Fire ... A-7 A.5.4. Smoke vacuation ... A-7 A.5.5. Direction of Laser Beam ... A-7

Appendix B

Clinical Applications

Page

B.1. Introduction ... B-1 B.2. Otolaryngology- General... B-1 B.2.1. Indications ... B-1 B.2.2. Contraindications ... B-1 B.2.3. Specific Precautions and Recommendations... B-1 B.2.4. Complications... B-2 B.2.5. References ... B-3 B.3. Laser Assisted Uvulopalatoplasty (LAUP) ... B-4 B.3.1. Indications ... B-4 B.3.2. Directions for Use ... B-4 B.3.3. Laser Delivery Systems ... B-5 B.3.4. Contraindications ... B-6 B.3.5. Specific Precautions and Recommendations... B-7

V

Table of Contents

Sharplan 40C

B.3.6. Complications... B-8 B.3.7. References ... B-8 B.4. Laser Assisted Myringotomy/ Tympanostomy ... B-10 B.4.1. Indications ... B-10 B.4.2. Contraindications ... B-10 B.4.3. Specific Precautions, Recommendations and Warnings ... B-10 B.4.4. Complications and Side Effects ... B-11 B.4.5. References ... B-11 B.5. Dermatology/Plastic Surgery... B-12 B.5.1. Indications ... B-12 B.5.2. Contraindications ... B-12 B.5.3. Specific Precautions, Recommendations and Warnings ... B-12 B. 5.4. Complications and Side Effects ... B-13 B.5.5. References ... B-13 B.6. Hair Transplantation... B-14 B.6.1. Indications ... B-14 B.6.2. Contraindications ... B-14 B.6.3. Specific Precautions, Recommendations and Warnings ... B-15 B.6.4. Complications and Side Effects ... B-15 B.6.5. References ... B-15 B.7. Gynecology... B-16 B.7.1. Indications ... B-16 B.7.2. Contraindications ... B-16 B.7.3.

Specific Precautions and Recommendations... B-16

B.7.4. Complications... B-17 B.7.5. References ... B-17 B.8. Neurosurgery ... B-18 B.8.1. Indications ... B-18 B.8.2. Contraindications ... B-18 B.8.3. Specific Precautions and Recommendations... B-18 B.8.4. Complications... B-19 B.8.5. References ... B-19 B.9. Orthopedics ... B-19

VI

Sharplan 40C

Table of Contents

B.9.1. Indications ... B-19 B.9.2. Contraindications ... B-19 B.9.3. Directions for Use ... B-20 B.9.4. Specific Precautions and Recommendations... B-20 B.9.5. Complications... B-20 B.9.6. References ... B-21 B.10. General/Thoracic Surgery ... B-21 B.10.1. Indications ... B-21 B.10.2. Contraindications ... B-21 B.10.3. Specific Precautions, Recommendations & Warnings... B-21 B.10.4. Complications... B-22 B.10.5. References ... B-22 B.11. Dentistry ... B-22 B.11.1. Indications ... B-22 B.11.2. Contraindications ... B-22 B.11.3. Specific Precautions Recommendations & Warnings... B-23 B.11.4. Complications... B-23 B.11.5. References ... B-23 B.12. Podiatry ... B-24 B.12.1. Indications ... B-24 B.12.2. Contraindications ... B-24 B.12.3. Specific Precautions, Recommendations & Warnings... B-24 B.12.4. Complications... B-24 B.12.5. References ... B-24 B.13. Genito-Urinary ... B-25 B.13.1. Indications ... B-25 B.13.2. Contraindications ... B-25 B.13.3. Specific Precautions, Recommendations & Warnings... B-25 B.13.4. Complications... B-25 B.13.5. References ... B-26

VII

Table of Contents

Sharplan 40C

List of Illustrations Figure

Description

Page

Figure 1- 1. Location of Warning, Identification and Certification Labels ... 1-5 Figure 2- 1. SHARPLAN 40C With Top Cover Assembled ... 2-1 Figure 2- 2. Dimensional Drawing - Side View... 2-2 Figure 2- 3. Dimensional Drawing - Top View ... 2-3 Figure 2- 4. Remote Interlock Connector Assembly... 2-4 Figure 3- 1. SHARPLAN 40C Laser Unit - Side View ... 3-3 Figure 3- 2. SHARPLAN 40C Laser Unit - Rear View... 3-4 Figure 3- 3. Optical System ... 3-6 Figure 3- 4. 125mm Handpiece Set in Handpiece Compartment ... 3-7 Figure 3- 5. Articulated Arm "Working", "Rest" and "Balanced" Position Angle Ranges ... 3-8 Figure 3- 6. Basic Concepts of General Periodic Function ... 3-10 Figure 3- 7. Laser Operation Modes ... 3-13 Figure 3- 8. Tissue Exposure Modes in CW Laser Operation Mode... 3-15 Figure 3- 9. Tissue Exposure Modes in SuperPulse Laser Operation Mode ... 3-16 Figure 3- 10. Tissue Exposure Modes in Pulser Laser Operation Mode ... 3-17 Figure 4- 1. SHARPLAN 40C - Top Panel... 4-2 Figure 4- 2. Control Panel... 4-5 Figure 4- 3. Auxiliary Panel... 4-6 Figure 5- 1. Balancing Articulated Arm ... 5-3 Figure 5- 2. Securing the Articulated Arm... 5-13 Figure 6- 1. 125mm Handpiece Assembly... 6-1 Figure 6- 2. SHARPLAN 712 Acuspot... 6-5 Figure 6- 3. SHARPLAN 719 Microslad... 6-6 Figure 6- 4. SHARPLAN SilkLaser Installed on the 40C Laser ... 6-10 Figure 6- 5. SHARPLAN SurgiTouch Installed on the Laser Unit’s Articulated Arm ... 6-10 Figure 6- 6. SHARPLAN Multi-Specialty SurgiTouch Installed on the 40C Laser Unit ... 6-11 Figure 8- 1. Power Distribution Schematic... 8-6 Figure A- 1. Tissue Effects at Varying Power Settings & Spot Sizes ... A-3

VIII

Sharplan 40C

Table of Contents

List of Tables Table

Description

Page

Table 3- 1. Laser Operation Modes vs. Tissue Exposure Modes ... 3-9 Table 5- 1. Power Setting Resolution ... 5-6 Table 5- 2. Time Setting Resolution ... 5-8 Table 5- 3. Operating Procedures Summary ... 5-14 Table 6- 1. Spot Diameters(mm) for the SHARPLAN 712 Acuspot... 6-5 Table 6- 2. SHARPLAN 719 Microslad Focal Spot Diameters ... 6-7 Table 7- 1. Recommended Routine Inspection and Maintenance Schedule... 7-2 Table 8- 1. Fault Messages - Troubleshooting Guide... 8-2 Table 8- 2. Undisplayed System Malfunctions - Troubleshooting Guide ... 8-4 Table A- 1. Power Density (in W/cm2) for Various Spot Sizes and Power Settings... A-4 Table A- 2. Laser Characteristics for Desired Tissue Effects ... A-5

IX

Table of Contents

Sharplan 40C

Figure 1. Sharplan 40C Laser Unit

X

CHAPTER 1 Operating Safety Precautions and Compliance with International Standards

1.1. General

The SHARPLAN 40C CO2 surgical laser system is specially designed to minimize accidental exposure to hazardous radiation.

Cautions 1. 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 40C system must be thoroughly familiar with all its safety requirements and operating procedures. 2. Improper use or adjustment of this system may invalidate the Lumenis service warranty agreement. Please contact your Lumenis 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 thirddegree 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 eyes. Never stare into the CO2 laser beam or allow it to be reflected from any reflective 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 use safety eyewear. Never stare directly into the He-Ne beam. Also ensure that the He-Ne beam is not directed at anyone's eyes. Although this beam is low powered, direct exposure can be hazardous to the eyes.

1-1

Operating Safety Precautions

1.4. Safety Eyewear

Sharplan 40C

All personnel in the vicinity of the laser unit must use safety eyewear and must ascertain that the eyewear provide 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 endoscope, as the glass lenses of these instruments provide sufficient protection.

1.5. 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. 3. For facial surgery, completely cover the patient's eyes with moistened eye pads.

1.6. 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.

1.7. High Voltage Hazard

The SHARPLAN 40C laser unit generates high voltages within the main cabinet. To avoid injury, do not operate the unit before ensuring that all of its panels are properly closed. Do not attempt to remove or disassemble any panels. Only Lumenis-authorized technical personnel may service the unit.

1.8. Using the Proper Power Receptacle and Plug

•

Use only the power receptacle and plug specified for your unit.

•

Use only a power receptacle and plug that are in good condition.

•

Use only a hospital grade plug and a correctly matched power receptacle.

1-2

Sharplan 40C

Operating Safety Precautions

To remove the power cord from the receptacle, hold it by the plug. Never pull on the power cord to remove the plug from the receptacle.

1.9. 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 Section 2.4.).

1.10. Fuse Replacement

The user may replace only the two line fuses that are located above the power cord connection on the auxiliary panel (see Figure 4-3, item 28). Access to fuses inside the main cabinet is limited to Lumenis- 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. Warning Before removing a fuse, turn off the keyswitch, remove the power cord from the AC outlet, and wait two minutes to allow high voltage discharge.

1.11. Compliance with International Standards

The SHARPLAN 40C 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 In accordance with these regulations, a recommended routine inspection and maintenance schedule is provided in the Maintenance chapter of this manual.

1-3

Operating Safety Precautions

1.12. Warning, Identification and Certification Labels

Sharplan 40C

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: A - on systems in Europe B - on systems in the USA 2. Non-Interlocked Warning Label – warning against: a. Risk of explosion if used in the presence of flammable anesthetics. b. Possible electrical shock when cover is removed. c. Possible radiation exposure when laser enclosure is opened. 3. Attention Label – instructing the user to use only the tab to lift the articulated arm. 4. Electric Shock Warning Label – warning user to properly ground the unit, against opening the unit's cover and information concerning: •

Degree and type of protection against electric shock

•

CE marking in compliance with the requirements of 93/42/EEC directive concerning medical devices (Annex II)

5. Identification Label – noting unit model number, serial number, electrical requirements and date of manufacture. 6. Certification Label – manufacturer and/or distributor details. (Location: on inside of service panel access door) 7. Laser Aperture Warning Label – indicating laser beam exit location.

1-4

Sharplan 40C

Operating Safety Precautions

Figure 1- 1. Location of Warning, Identification and Certification Labels

1-5

CHAPTER 2 Installation

2.1. Unpacking and Inspection

The SHARPLAN 40C laser system has passed full quality assurance testing before shipment. Thus, the unit should be operational upon delivery. The unit should be unpacked, installed and tested only by an authorized Lumenis representative. 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 Lumenis distributor.

2.2. Equipment List

The SHARPLAN 40C system includes the following: 1. SHARPLAN 40C laser unit 2. 125mm handpiece set (in handpiece compartment) 3. Footswitch (in footswitch compartment) 4. Power cord (in footswitch housing) 5. Set of master keys (in handpiece compartment) 6. Spare fuses (in foam insert inside top cover) 7. User's manual (in pocket of plastic covering) 8. Remote interlock connector assembly (in foam insert inside top cover) 9. Remote interlock connection point cap (installed) 10. Disposable bacteriological filter (one installed, two in Styrofoam container) 11. Protective cover (in plastic bag)

Figure 2- 1. SHARPLAN 40C With Top Cover Assembled

12. Laser radiation warning sign

2-1