Operators Manual
190 Pages
Preview
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AcuPulse DUO
TM
Carbon Dioxide Laser Operator Manual
This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Lumenis. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes translation into another language. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Lumenis, the Lumenis logo, AcuPulse, AcuPulse DUO, FiberLase, FiberLase ENDURE, SurgiTouch, AcuScan120, Pulser, SuperPulse, AcuSpot 712, Digital AcuBlade, OtoLAM, StretchTouch, ToeTouch, FineTouch, FeatherTouch, SilkTouch and BeamAlign are trademarks or registered trademarks of Lumenis. Caution: US federal law restricts this device to sale by or on the order of a physician.
Copyright © 2013, Lumenis Ltd. Catalog Part Number: UM-1801110EN September 2013 Revision A
Use of this Manual: The AcuPulse DUO laser system is designed to meet international safety and performance standards. Personnel operating the system 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 physician training or professional training on the clinical use of the AcuPulse DUO CO2 laser system. Such training should include a review of published literature, seminars, workshops and appropriate preceptorships. Please contact your Lumenis representative for current information on available training. This manual should always accompany the system, and its location must be known to all personnel operating the system. Additional copies of this manual are available from your Lumenis distributor. System and accessory specifications subject to change without notice. For further information about Lumenis, visit the Lumenis Website: http://www.Lumenis.com or send email to [email protected]
Authorized Representative in the European Community: Lumenis GmbH Germany Heinrich-Hertz-Strasse 3 D-63303 Dreieich-Dreieichenhain Germany Manufactured by Lumenis Ltd. Yokneam Industrial Park 6 Hakidma Street P.O.B. 240 Yokneam 2069204, Israel Tel: +972-4-959-9000
Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) In accordance with Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE), any item which is marked with the crossed-out wheelie bin symbol must not be disposed of as unsorted municipal waste, but segregated from other waste types for eventual treatment and recovery at an approved recycling facility. By returning waste electrical and electronic equipment via the correct segregated disposal channel, users can ensure the environmentally sound treatment and disposal of the waste equipment, thereby reducing the potential for any environmental or health risks that could arise as a result of incorrect disposal. Lumenis provides web-based collection, recycling and reporting arrangements to the business end-user for equipment marked with the crossed-out wheelie bin. Please visit www.lumenis.com/recycling to understand what arrangements Lumenis has made in each EU Member State.
AcuPulse DUO
TM
Table of Contents
Table of Contents CHAPTER 1
1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 1.7. 1.8. 1.9. 1.10.
Overview
Page
Introduction ... 1-1 Characteristics of the CO2 Laser Beam... 1-2 Laser Preparation ... 1-2 Scope of This Manual ... 1-2 Manual Conventions ... 1-4 Physician Responsibility ... 1-4 Maintenance ... 1-4 Modification of the Device ... 1-5 Resale Inspection ... 1-5 Abbreviations and Acronyms ... 1-5
CHAPTER 2
Laser Safety
Page
2.1. 2.2.
Introduction ... 2-1 Training and Institutional Requirements... 2-1 2.2.1. Laser Safety Guidelines... 2-2 2.2.2. Laser Safety Officer ... 2-2 2.2.3. Laser Treatment/ Operating Area ... 2-3 2.3. Understanding and Controlling Laser Impact on Tissue ... 2-4 2.3.1. Laser Classes ... 2-5 2.3.2. Wavelength and Tissue Variability ... 2-5 2.3.3. Spot Size, Power and Exposure ... 2-6 2.4. Laser Safety Eyewear ... 2-6 2.4.1. Additional Ocular Protection... 2-9 2.5. Additional Safety Considerations ... 2-10 2.5.1. Skin Hazards ... 2-10 2.5.2. Smoke Evacuation – Laser Plume Pollution Hazards ... 2-11 2.5.3. Airway Precautions ... 2-12 2.5.4. Protecting Non-Target Tissues ... 2-12 2.6. Fire Hazards ... 2-14 2.7. Electrical Hazards ... 2-15 2.7.1. Grounding the System ... 2-15 2.8. Operating Safety Cautions & Warnings... 2-16 2.8.1. Cautions ... 2-16 2.8.2. Warnings ... 2-17
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2.9.
System Safety Features ... 2-18 2.9.1. Patient Protection ... 2-18 2.9.2. Password Protection ... 2-18 2.9.3. Self-Testing at Start Up ... 2-18 2.9.4. Safety Shutter ... 2-18 2.9.5. Door Interlock Connector ... 2-18 2.9.6. Safety Interlocks and Failsafes ... 2-19 2.9.6.1. Dual-Footswitch Microswitch... 2-19 2.9.6.2. Laser Stop Button... 2-19 2.9.6.3. Shutter Position Failsafe ... 2-19 2.9.6.4. Power Measurement Failsafe ... 2-19 2.9.6.5. Articulated Arm / CO2 Fiber Switching Failsafe ... 2-19 2.9.7. Safety Timer ... 2-19 2.9.8. Continuous Internal System Monitoring ... 2-20 2.9.8.1. System Faults ... 2-20 2.9.8.2. Internal Power Monitoring ... 2-20 2.9.8.3. Temperature ... 2-20 2.10. Radiofrequency Emissions... 2-20 2.10.1. Laser Beam Emission Indicators... 2-21 2.11. Compliance with International Standards ... 2-22 2.12. Warning, Certification and Identification Labels ... 2-22
CHAPTER 3
System Installation
Page
3.1. 3.2. 3.3.
Introduction ... 3-1 Unpacking the System ... 3-1 Facility Requirements ... 3-2 3.3.1. Space and Positioning Requirements ... 3-2 3.3.2. Electrical Requirements ... 3-3 3.3.3. Environmental Requirements ... 3-3 3.4. Installation and Setup... 3-3 3.4.1. Articulated Arm Setup... 3-5 3.4.2. Bacteriological Filter Installation ... 3-6 3.4.3. Handpiece Support Arm Installation ... 3-7 3.4.4. Service Panel Connections ... 3-8 3.5. Initial System Testing ... 3-9 3.5.1. System Controls ... 3-9 3.5.2. Main Control Panel ... 3-9 3.5.3. System Start Up ... 3-9
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TM
Table of Contents
3.5.4. Door Interlock Check ... 3-10 3.5.5. Footswitch Connection Check... 3-10 3.5.6. Laser Energy Emission Mode Check ... 3-11 3.5.7. Laser Stop Button Check ... 3-11 3.6. Moving, Transporting and Storage ... 3-12 3.6.1. Moving the System within the Facility ... 3-12 3.6.2. Transporting the System ... 3-12
CHAPTER 4
System Description
Page
4.1. 4.2. 4.3. 4.4.
General Laser Theory ... 4-1 CO2 Laser Theory ... 4-1 AcuPulse DUO Laser System ... 4-2 System Description ... 4-3 4.4.1. Control Panel ... 4-5 4.4.2. Optical Bench Assembly ... 4-6 4.4.3. Cooling System ... 4-6 4.4.4. Service Panel ... 4-7 4.4.4.1. Potential Equalization ... 4-7 4.4.4.2. Footswitch Connection ... 4-8 4.4.4.3. Door Interlock Connection... 4-8 4.4.4.4. Smoke Evacuator Connection ... 4-8 4.4.4.5. Power Circuit Breaker ... 4-8 4.4.4.6. Power Cable Connection ... 4-8 4.4.4.7. USB Connections ... 4-8 4.4.4.8. VGA Monitor Connection ... 4-9 4.5. Understanding Laser Delivery ... 4-9 4.5.1. Exposure Types ... 4-10 4.6. System Specifications ... 4-13 4.6.1. Outputs ... 4-13 4.6.2. Operation and Control ... 4-15 4.6.3. Cooling System ... 4-16 4.6.4. Electrical Requirements ... 4-16 4.6.5. Physical Specifications ... 4-16 4.6.6. Environmental Specifications... 4-16 4.6.7. System Classifications ... 4-17
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Table of Contents
CHAPTER 5
Operating Instructions
AcuPulse DUO
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Page
5.1. 5.2. 5.3.
Introduction ... 5-1 Safety Considerations ... 5-1 Starting the System ... 5-2 5.3.1. Before Turning On the System ... 5-2 5.3.2. Bacteriological Filter Inspection ... 5-3 5.3.2.1. Purge Air Supply Options ... 5-4 5.3.2.2. Connection to External Purge Air Source ... 5-5 5.3.3. CO2 Fiber Connection ... 5-6 5.3.4. Handpiece Sterility during Operation ... 5-8 5.4. Operating the System ... 5-9 5.5. SurgiTouch Treatment ... 5-12 5.5.1. Select Specialty ... 5-12 5.5.2. SurgiTouch Menu ... 5-13 5.5.3. Treatment Screen: Scan Mode... 5-14 5.5.4. Treatment Screen: No Scan Mode... 5-18 5.6. Manual Treatment ... 5-19 5.7. CO2 Fiber Treatments ... 5-20 5.8. Aesthetic Treatments ... 5-24 5.8.1. Fractional Applications ... 5-26 5.9. User Presets... 5-28 5.9.1. Programming User Presets ... 5-28 5.9.2. My Settings ... 5-29 5.9.3. Fix Settings ... 5-30 5.10. Atlas of AcuPulse Accessories ... 5-31 5.11. Preferences ... 5-32 5.11.1. General Preferences ... 5-32 5.11.2. Air Flow Preferences ... 5-34 5.11.3. Sound Preferences ... 5-35 5.12. Utilities Menu ... 5-36 5.12.1. Disconnecting the Scanner ... 5-37 5.12.2. Installing a New Scanner ... 5-38 5.12.3. Users List ... 5-39 5.12.3.1. Add User ... 5-40 5.12.3.2. Edit User ... 5-41 5.12.4. Database Backup ... 5-42 5.13. System Messages ... 5-43 5.14. System Shut-Down ... 5-43
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AcuPulse DUO
CHAPTER 6
TM
Delivery Systems
Table of Contents
Page
6.1. 6.2.
Introduction ... 6-1 F125 Incisional Handpiece Set ... 6-1 6.2.1. Handpiece Assembly ... 6-1 6.3. Scanning Accessories... 6-2 6.3.1. Scanning Accessories Operator Manuals ... 6-3 6.3.2. Setting up a Scanning Accessory System ... 6-4 6.3.3. Cleaning the Optical Heads ... 6-5 6.4. Beam Alignment Check ... 6-5 6.5. CO2 Fibers and Fiber Accessories ... 6-7 6.6. Optional Accessories ... 6-9 6.7. Cleaning, High-level Disinfection and Sterilization ... 6-10 6.7.1. General ... 6-10 6.7.2. Repeated Sterilization or High-level Disinfection ... 6-10 6.7.3. Cleaning Procedure ... 6-11 6.7.4. Sterilization Techniques ... 6-12 6.7.5. High-level Disinfection Techniques ... 6-12
CHAPTER 7
Maintenance
Page
7.1. 7.2. 7.3. 7.4. 7.5.
Introduction ... 7-1 Service Information ... 7-1 Routine Periodic Maintenance ... 7-2 Lumenis Service ... 7-3 Clinic Staff Maintenance ... 7-3 7.5.1. Visual Inspection ... 7-3 7.5.2. Routine Exterior Cleaning ... 7-3 7.5.3. Safety Interlock Checks... 7-3 7.5.3.1. Door Interlock ... 7-4 7.5.3.2. Laser Stop Button Check ... 7-4 7.5.4. Purge Air Flow Check from Internal Pump ... 7-4 7.6. Professional Maintenance ... 7-5 7.6.1. Power Meter Calibration ... 7-5 7.6.1.1. Internal Power Meter Check ... 7-5 7.7. Software Upgrade ... 7-7 7.8. HASP Upgrade ... 7-7 7.9. Moving and Transporting the System ... 7-8 7.9.1. Moving the Assembled System ... 7-8 7.9.2. Transporting the System ... 7-8
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Table of Contents
CHAPTER 8
8.1. 8.2. 8.3. 8.4. 8.5.
Troubleshooting
AcuPulse DUO
TM
Page
Introduction ... 8-1 Warranty ... 8-1 Hazard Precautions ... 8-1 Troubleshooting Guides ... 8-1 Scanner Position Error ... 8-6
APPENDIX A
Clinical Guide: Surgical Applications with the Articulated Arm
Page
A.1. Introduction ... A-1 A.2. Indications for Use ... A-1 A.3. Contraindications ... A-2 A.4. General Laser Recommendations ... A-2 A.5. General Safety Considerations ... A-2 A.6. Podiatry ... A-3 A.6.1. Podiatry Indications ... A-3 A.6.2. Safety Considerations and Complications for Podiatry ... A-3 A.7. Otolaryngology (ENT) ... A-3 A.7.1. ENT Indications ... A-3 A.7.2. ENT Contraindications ... A-5 A.7.3. Safety Considerations for General ENT ... A-5 A.7.3.1. Safety Considerations for LAUP ... A-5 A.7.3.2. Safety Considerations for Myringotomy/ Tympanostomy... A-6 A.7.4. ENT Complications and Expected Sequelae... A-6 A.8. Gynecology and GYN Laparoscopy ... A-7 A.8.1. Gynecology and GYN Laparoscopy Indications ... A-7 A.8.2. Gynecology and GYN Laparoscopy Contraindications ... A-8 A.8.3. Safety Considerations for Gynecology and GYN Laparoscopy ... A-8 A.8.4. Gynecology and GYN Laparoscopy Complications ... A-8 A.9. Neurosurgery Indications ... A-9 A.9.1. Neurosurgery Contraindications ... A-9 A.9.2. Safety Considerations for Neurosurgery ... A-9 A.9.3. Neurosurgery Complications ... A-9 A.10. Orthopedics ... A-10 A.10.1. Orthopedics Indications ... A-10 A.10.2. Safety Considerations for Orthopedics ... A-10 A.10.3. Orthopedics Complications ... A-10 A.11. General and Thoracic Surgery ... A-11 A.11.1. General and Thoracic Surgery Indications ... A-11
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A.11.2. Contraindications for General and Thoracic Surgery ... A-11 A.11.3. Safety Considerations for General and Thoracic Surgery ... A-11 A.11.4. General and Thoracic Surgery Complications ... A-11 A.12. Dental and Oral Surgery ... A-12 A.12.1. Dental and Oral Surgery Indications ... A-12 A.12.2. Contraindications for Dental and Oral Surgery ... A-12 A.12.3. Safety Considerations for Dental and Oral Surgery ... A-12 A.12.3.1. Complications of Dental and Oral Surgery ... A-13 A.13. References ... A-13
APPENDIX B
Surgical Applications with the CO2 Fibers
Page
B.1. Introduction ... B-1 B.2. General Indications for Use ... B-1 B.3. General Laser Recommendations ... B-2 B.4. General Contraindications ... B-2 B.5. Podiatry Indications... B-3 B.5.1. Safety Considerations and Complications for Podiatry ... B-3 B.5.2. Podiatry Contraindications ... B-3 B.6. Otolaryngology (ENT) Indications ... B-3 B.6.1. Contraindications ... B-3 B.6.2. Safety Considerations for ENT ... B-4 B.6.2.1. Complications and Expected Sequelae... B-5 B.6.3. Safety Considerations for LAUP ... B-5 B.6.3.1. Complications... B-6 B.6.4. Safety Considerations for Myringotomy/Tympanostomy (Tympanic Membrane Fenestration) ... B-6 B.6.4.1. Precautions and Recommendations ... B-6 B.6.4.2. Complications... B-6 B.7. Gynecology and GYN Laparoscopy Indications ... B-7 B.7.1. Contraindications ... B-7 B.7.2. Complications ... B-7 B.8. Neurosurgery Indications ... B-8 B.8.1. Contraindications ... B-8 B.8.2. Safety Considerations for Neurosurgery ... B-8 B.8.3. Complications ... B-9 B.9. Orthopedics Indications... B-9 B.9.1. Contraindications ... B-9 B.9.2. Safety Considerations for Orthopedics ... B-9 B.9.3. Complications ... B-9
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B.10. General and Thoracic Surgery Indications ... B-10 B.10.1. Contraindications ... B-10 B.10.2. Safety Considerations for General and Thoracic Surgery ... B-10 B.10.3. Complications ... B-10 B.11. Dental and Oral Surgery Indications ... B-10 B.11.1. Contraindications ... B-10 B.11.2. Complications ... B-10 B.12. References ... B-11
APPENDIX C
Clinical Guide: Aesthetic Applications with the Articulated Arm
Page
C.1. Introduction ... C-1 C.2. Indications for Use ... C-1 C.3. General Contraindications ... C-2 C.4. Dermatology and Plastic Surgery Contraindications ... C-3 C.5. General Laser Recommendations ... C-3 C.6. General Laser Safety Considerations ... C-3 C.7. Dermatology/Plastic Surgery (Aesthetic) ... C-4 C.7.1. Dermatology/ Plastic Surgery Indications ... C-4 C.7.2. Dermatology and Plastic Surgery Contraindications ... C-5 C.7.3. Safety Considerations for Dermatology and Plastic Surgery ... C-5 C.7.4. Complications, Expected Side Effects and Immediate Responses ... C-6 C.8. Patient Care and Treatment Recommendations ... C-8 C.8.1. Pre-Operative Care ... C-9 C.8.2. Post-Operative Care ... C-10 C.9. Adverse Event Management ... C-11 C.10. References ... C-12
APPENDIX D
EMC Guidance and Manufacturer's Declaration
Page
D.1. Electromagnetic Emissions ... D-1 D.2. Electromagnetic Immunity ... D-2 D.3. Recommended Separation Distances ... D-4
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Table of Contents
List of Illustrations Figure 2-1: Laser Treatment Room Warning Sign ... 2-3 Figure 2-2: CO2 Emission Port Indicators ... 2-21 Figure 2-3: System Labels ... 2-24 Figure 3-1: Physical Dimensions ... 3-2 Figure 3-2: Assembled AcuPulse DUO Laser System ... 3-4 Figure 3-3: Release the Articulated Arm ... 3-5 Figure 3-4: Bacteriological Filter Installation ... 3-6 Figure 3-5: Handpiece Support Arm Clamp Installation ... 3-7 Figure 3-6: Handpiece Support Arm Installation ... 3-7 Figure 3-7: Service Panel ... 3-8 Figure 3-8: Control Panel... 3-10 Figure 4-1: CO2 Laser Beam Divergence from Fiber and Articulated Arm Handpiece ... 4-2 Figure 4-2: Gas Management System (GMS)... 4-4 Figure 4-3: Control Panel... 4-5 Figure 4-4: AcuPulse DUO Treatment Screen (sample)... 4-6 Figure 4-5: Service Panel ... 4-7 Figure 4-6: CW Exposure Types ... 4-10 Figure 4-7: Pulser Exposure Types ... 4-11 Figure 4-8: SuperPulse Exposure Types ... 4-12 Figure 5-1: Connection to External Purge Air Source ... 5-5 Figure 5-2: Connecting the CO2 Fiber ... 5-6 Figure 5-3: Handpiece Support Arm... 5-8 Figure 5-4: Login Screen ... 5-9 Figure 5-5: Home Screen ... 5-10 Figure 5-6: Select Specialty Screen ... 5-12 Figure 5-7: SurgiTouch Menu Screen – ENT ... 5-13 Figure 5-8: SurgiTouch Treatment Screen – Scan Mode... 5-14 Figure 5-9: SurgiTouch Treatment Screen – No Scan Mode ... 5-18 Figure 5-10: Treatment Screen – Manual Settings ... 5-19 Figure 5-11: CO2 Fiber Treatment Screen ... 5-21 Figure 5-12: Aesthetics Menu Screen ... 5-24 Figure 5-13: Aesthetics Treatment Screen ... 5-25 Figure 5-14: Aesthetics Treatment Screen: Deep, Superficial, Combo and StretchTouch ... 5-26 Figure 5-15: Add Settings Screen ... 5-28 Figure 5-16: My Settings Screen ... 5-29 Figure 5-17: SurgiTouch Presets Screen ... 5-30
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Figure 5-18: Atlas of Accessories Screen ... 5-31 Figure 5-19: General Preferences Screen... 5-32 Figure 5-20: Air Flow Preferences Screen ... 5-34 Figure 5-21: Sound Preferences Screen ... 5-35 Figure 5-22: Utilities Menu Screen ... 5-36 Figure 5-23: Disconnect Scanner Pop-Up Message... 5-37 Figure 5-24: New Scanner Upgrade Pop-Up ... 5-38 Figure 5-25: Users List Screen... 5-39 Figure 5-26: Add User Screen ... 5-40 Figure 5-27: Edit User Screen ... 5-41 Figure 5-28: Database Backup Screen ... 5-42 Figure 6-1: F125 Incisional Handpiece ... 6-1 Figure 6-2: SurgiTouch Beam Scanning Pattern ... 6-2 Figure 6-3: Setting Up the Scanning Accessory (for illustration purposes only) ... 6-4 Figure 6-4: Beam Alignment Check Results ... 6-6 Figure 7-1: System Hasp Plug Upgrade Pop-Up Window... 7-7 Figure 8-1: Scanner Position Error (for illustration only) ... 8-6
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UM-1801110EN, Rev. A
Chapter 1 Overview
AcuPulse DUO encompasses a family of DC-excited CO2 laser system models for use in a variety of surgical and aesthetic applications.
1.1. Introduction
The AcuPulse DUO system is equipped with two means of laser energy emission: •
Articulated arm
•
CO2 hollow waveguide (fiber)
The following table describes the various configurations of systems in the AcuPulse DUO family: AcuPulse DUO System
Max. Power [W]
SurgiTouch Enabled
Description
Duo 30
30
CO2 laser system (30 Watts) with Manual operating mode.
Duo 30ST
30
CO2 laser system (30 Watts) with Manual and SurgiTouch operating modes.
Duo 40
40
CO2 laser system (40 Watt) with Manual operating mode.
Duo 40ST
40
CO2 laser system (40 Watts) with Manual and SurgiTouch operating modes.
Duo 40AES-A
40
CO2 laser system (40 Watts) with Manual, SurgiTouch and Aesthetic operating modes (Fractional and Conventional Resurfacing).
The AcuPulse DUO systems deliver maximal power of:
UM-1801110EN, Rev. A
Beam Exposure Mode: Î
30 Watt System Max. Power Delivered
40 Watt System Max. Power Delivered
Continuous Wave Mode
30 Watts
40 Watts
Pulser Mode
25 Watts
35 Watts
SuperPulse Mode
10 Watts
15 watts
1-1
AcuPulse DUO
Overview
1.2. Characteristics of the CO2 Laser Beam
The CO2 laser wavelength falls in the mid-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye.
1.3. Laser Preparation
The laser is shipped directly from the factory to your site. Your local Lumenis representative initially uncrates, inspects, sets up and installs the laser to ensure that it is ready for use. In addition, Lumenis provides inservice training to ensure that your staff is experienced with the operation and safety considerations of the laser.
TM
Carbon dioxide laser energy is readily absorbed by water in tissue. Since soft tissue is comprised primarily of water, CO2 laser energy can be used effectively for the excision, incision, ablation, vaporization, and coagulation of soft tissue.
Thereafter, you or the staff at your facility will perform the daily maintenance routines associated with the laser and with any delivery systems and/or accessories used during surgery, including inspecting and cleaning the laser and delivery systems; sterilizing and connecting/ disconnecting the accessories. These procedures are detailed in this manual. Most nursing staff prefer to inspect the laser and delivery systems daily, usually prior to scheduled cases and before patients are premedicated. Doing so will ensure adequate time to troubleshoot a problem or seek professional service with the least disruption to patient care. These routine tasks may be performed outside of the sterile field; in this case, ensure enough time to sterilize any components, as necessary, before scheduled cases.
1.4. Scope of This Manual
This manual is intended to provide the surgeon and other personnel who operate or maintain the system with information regarding the operating principles, controls, safety precautions, installation and maintenance of the system. While this manual is intended to aid in the in the use and care of the equipment, it does not serve as a substitute for proper training in the clinical applications of medical laser devices. This operator's manual incorporates the following chapters:
1-2
Chapter 1:
Overview
Contains a general introduction to the system.
Chapter 2:
Laser Safety
Contains explanations and directions concerning safety measures for operating the system. This chapter also includes regulatory information and requirements.
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Overview
Chapter 3:
System Installation
Lists electrical, space and environmental requirements for installation of the system and basic installation instructions.
Chapter 4:
System Description
Contains a detailed overview of the system and its various components, controls, displays and connections. Includes detailed specifications of all facets of the system.
Chapter 5:
Operating Instructions
Explains how to operate the system.
Chapter 6:
Delivery Systems Describes the various delivery systems used with the AcuPulse DUO.
Chapter 7:
Maintenance
Chapter 8:
Troubleshooting Lists the system's error messages that might occur during operation, their probable causes and what actions to take.
Provides a detailed review of how to maintain the system.
Appendix A: Clinical Guide: Offers information about staff training, indications and contraindications for Surgical Applications with use, recommended setup parameters and the Articulated suggested professional reference literature. Arm Appendix B: Clinical Guide: Offers information about staff training, indications and contraindications for Surgical Applications with use, recommended setup parameters and suggested professional reference the CO2 Fiber literature. Appendix C: Clinical Guide: Offers information about staff training, indications and contraindications for Aesthetic Applications with use, recommended setup parameters and the Articulated suggested professional reference literature. Arm Appendix D: EMC Guidance
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Describes the electromagnetic environment in which the system may be operated.
1-3
AcuPulse DUO
Overview
1.5. Manual Conventions
TM
Throughout this manual, notes, cautions and warnings and are used to provide critical information needed before the device is used. Examples: Note A Note is a statement that alerts the operator to particularly important information.
Caution A Caution is a statement that alerts the operator to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, device failure, and damage to the device or other property. The caution statement includes the precaution that should be taken to avoid the hazard.
Warning A Warning is a statement that alerts the operator to the possibility of injury, death, or serious adverse reactions associated with the use or misuse of the device.
1.6. Physician Responsibility
Federal (USA) law restricts prescription medical devices to sale by or on the order of a physician, or properly licensed practitioner. The properly licensed practitioner will be responsible for the use and operation of the device and for all user qualifications. Lumenis makes no representations regarding federal, state or local laws or regulations that might apply to the use and operation of any medical device. The physician is responsible for contacting his or her local licensing agencies to determine any credentials required by law for clinical use and operation of the device.
1.7. Maintenance
1-4
The AcuPulse DUO is a precision, technical medical device that requires routine service. All service must be performed by a Lumenis technician and all parts must be purchased from Lumenis. Failure to obtain service and parts through Lumenis voids all warranties, express and implied. Please call Lumenis or your local representative for details.
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1.8. Modification of the Device
Overview
Unauthorized modification of the hardware, software or specifications of the AcuPulse DUO voids all warranties, express and implied. Lumenis takes no responsibility for the use or operation of such a device. Caution Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment.
1.9. Resale Inspection
The AcuPulse DUO is a precision, technical medical device. If any Lumenis device is resold by anyone other than an authorized sales representative, Lumenis offers a resale inspection by a Lumenis technician to assure that the device is working in accordance with manufacturer’s specifications. Using the device after it has been resold and before it has been inspected is a misuse of the device, which may result in injuries and voids all warranties, express and implied. Lumenis also offers service contracts and extended warranties for its devices. For more information about the services or about the costs of inspections or service calls, please call Lumenis or your local representative.
1.10. Abbreviations and Acronyms
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"
Inches
°C
Degrees Celsius
°F
Degrees Fahrenheit
ANSI
American National Standards Institute
CE
European Directives Compliance Marking
cm
Centimeters
CO2
Carbon Dioxide
CW
Continuous Wave
DC
Direct Current
ENT
Ear, Nose and Throat
FDA
Food & Drug Administration (USA)
GUI
Graphic User Interface
GYN
Gynecology
HP-M
Handpiece –Malleable
HP-R
Handpiece – Rigid
1-5
AcuPulse DUO
Overview
Hz
Hertz
IEC
International Electrotechnical Commission International Standards Organization
ISO 2
1-6
TM
J/cm
Joules per square centimeter
kg
Kilogram
lbs
Pounds
LAM
Laser-Assisted Myringotomy
LAN
Local Area Network
LAUP
Laser-Assisted Uvulopalatoplasty
LCD
Liquid Crystal Display
LED
Light Emitting Diode
m
Meters
mJ
MilliJoules
mm
Millimeters
mW
MilliWatts
nm
Nanometers
OD
Optical Density
PS
Power Supply
SP
SuperPulse
UL
Underwriters Laboratories
USB
Universal Serial Bus
VAC
Volts, Alternating Current
W
Watts
WG
Waveguide
UM-1801110EN, Rev. A
2.
Chapter 2 Laser Safety
2.1. Introduction
Operators must take precautions to prevent exposure of laser energy to the eyes and skin from either direct or diffusely reflected laser beams, except as a therapeutic application. Additional precautions must be taken to prevent fire, electrical injury, and explosion. Lumenis does not make recommendations regarding the practice of medicine. Laser treatment parameters are provided as a guide. Individual treatment should be based on clinical training, clinical observation of laser-tissue interaction, and appropriate clinical endpoints. Patient safety should always be the clinician's first concern. This chapter of the manual includes the minimum information required to operate the system safely. In addition to the guidelines presented here, follow all applicable institutional procedures. Read this chapter completely before attempting a procedure with the AcuPulse DUO laser system. This chapter includes:
• Basic institutional requirements, including responsibilities of the Laser Safety Officer.
• How and why the laser impacts tissue, and how this is controlled. • Hazards associated with unsafe laser use. • Safety features of the AcuPulse DUO. • Notes, precautions, cautions and warnings associated with the AcuPulse DUO.
2.2. Training and Institutional Requirements
Caution No one should use the AcuPulse DUO, or any other medical laser, without specific training in both medical laser use and laser safety.
Both user and safety training is available from Lumenis. Contact your Lumenis representative to inquire about seminars in your area.
UM-1801110EN, Rev. A
2-1