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Carbon Dioxide Laser Service Manual
Copyright © 2009, the Lumenis group of companies. All rights reserved. Lumenis, the Lumenis logo, AcuPulse, SurgiTouch, Pulser, SuperPulse, Acuscan 120, AcuSpot 712, Digital AcuBlade, OtoLAM and BeamAlign are trademarks or registered trademarks of Lumenis. 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. Caution: U.S. law restricts this device to sale by or on the order of a physician.
Notes: 1. System and Accessory specifications subject to change without notice. 2. Manual Catalog No. PB0000300 3. Manual Catalog Version "A" 4. Prepared October, 2009
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Use of Manual:
The AcuPulse system is designed to meet international safety and performance standards. Personnel operating or servicing the system must have a thorough understanding of the proper operation of the system. This manual has been prepared to aid Lumenis-authorized technical personnel to understand and service the system. Do not operate the system before reading this manual and gaining a clear understanding of the operation of the system.
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Regulatory European Representative: Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich Germany
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PHYSICIAN RESPONSIBILITY Federal (USA) law restricts prescription medical devices to sale by or on the order of a physician, or properly licensed practitioner. That physician 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.
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PREVENTIVE MAINTENANCE The AcuPulse system is a precision, technical medical device that requires routine service as well as consumable parts. All service must be performed by a Lumenis authorized 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.
MODIFICATION OF DEVICE Unauthorized modification of the hardware, software or specifications of the system voids all warranties, express and implied. Lumenis takes no responsibility for the use or operation of such a device.
RESALE INSPECTION The AcuPulse system 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.
RELEVANT DOCUMENTS AcuPulse System (Surgical) Operator Manual (P/N # UM-1053720) AcuPulse System (Aesthetic) Operator Manual (P/N # UM-1061050)
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Publication No. PB0000300
Revision A
Description FIrst Release
Date October, 2009
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TABLE OF CONTENTS
Chapter 1: Introduction
1.1 Introduction.................................................................................................. 1-1
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1.2 Characteristics of the CO2 Laser Beam....................................................... 1-2 1.3 Scope of This Manual.................................................................................. 1-2 1.4 Manual Conventions.................................................................................... 1-3 1.5 Applicable Documents................................................................................. 1-4 1.6 Abbreviations and Acronyms ...................................................................... 1-4
Chapter 2: Safety
2.1 Introduction.................................................................................................. 2-1 2.2 Laser Safety Guidelines............................................................................... 2-2
2.2.1 Laser Safety Officer......................................................................................2-2 2.2.2 Laser Treatment/Operating Area .................................................................2-3
2.3 Understanding and Controlling Laser Impact on Tissue ............................. 2-3
2.3.1 Laser Classes................................................................................................2-4 2.3.2 Wavelength and Tissue Variability...............................................................2-5 2.3.3 Spot Size, Power, and Exposure...................................................................2-5
2.4 Hazards Associated with Unsafe Laser Use ................................................ 2-6
2.4.1 Burn Hazards ...............................................................................................2-6
2.5 Reflection and Direct Eye Exposure Hazard ............................................... 2-7
2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.5.6 Laser Safety Eyewear ...................................................................................2-7 Additional Ocular Protection.......................................................................2-8 Fire Hazards.................................................................................................2-8 Electrical Hazards........................................................................................2-9 Grounding the System ..................................................................................2-9 Toxic Hazard ..............................................................................................2-10
2.6 System Safety Features.............................................................................. 2-10
2.6.1 2.6.2 2.6.3 2.6.4 Password Protection ..................................................................................2-11 Self Testing at Login...................................................................................2-11 Safety Shutter..............................................................................................2-12 Door Interlock Connector ..........................................................................2-12
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2.6.5 Circuit Breaker...........................................................................................2-12 2.6.6 Footswitch Dual-Microswitch ....................................................................2-12 2.6.7 Emergency Stop Button ..............................................................................2-12 2.6.8 Internal Power Meter .................................................................................2-13 2.6.9 Safety Timer................................................................................................2-13 2.6.10 Continuous Internal System Monitoring ..................................................2-13 2.6.11 Laser Beam Emission Indicators..............................................................2-14 2.6.12 On Line Monitor.......................................................................................2-14
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2.7 Compliance with International Standards.................................................. 2-15 2.8 Warning, Certification and Identification Labels ...................................... 2-16
Chapter 3: Installation
3.1 Introduction.................................................................................................. 3-1
3.1.1 Required Tools .............................................................................................3-2
3.2 Facility Requirements.................................................................................. 3-2
3.2.1 Space and Positioning Requirements ...........................................................3-2 3.2.2 Electrical Requirements ...............................................................................3-3 3.2.3 Environmental Requirements .......................................................................3-4
3.3 Unpacking the Unit...................................................................................... 3-4 3.4 Installation and Setup ................................................................................ 3-13
3.4.1 Smoke Evacuator Installation ....................................................................3-14 3.4.2 Remote Interlock System Installation .........................................................3-14 3.4.3 Articulated Arm Setup ................................................................................3-15 3.4.4 Handpiece Assembly...................................................................................3-16 3.4.5 Scanning Accessories .................................................................................3-18 3.4.6 Setting up the AcuScan 120 Microscanner.................................................3-20 3.4.7 Cleaning the Optical Head.........................................................................3-20 3.4.8 Check Articulated Arm Balance .................................................................3-21 3.4.9 Bacteriological Filter Installation..............................................................3-22 3.4.10 Footswitch Connection.............................................................................3-22
3.5 Initial System Testing ................................................................................ 3-22
3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 System Controls..........................................................................................3-23 Main Control Panel....................................................................................3-23 System Startup and Self Test ......................................................................3-23 Remote Interlock Check..............................................................................3-26 Footswitch Connection Check....................................................................3-26 Emergency Stop Button Check ...................................................................3-26
3.6 Final Checks .............................................................................................. 3-27
3.6.1 Equipment Required for the Checks ...........................................................3-27 3.6.2 General Preliminary Check........................................................................3-27
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3.6.3 Aiming Beam Check ...................................................................................3-27 3.6.4 Laser Radiation Leakage Test....................................................................3-29 3.6.5 Laser Alignment Checks .............................................................................3-29 3.6.6 Power Meter Calibration Check ................................................................3-29 3.6.7 Operational Checks....................................................................................3-30 3.6.8 Turn-Off Procedure....................................................................................3-31 3.6.9 Setting User Names and Passwords...........................................................3-31 3.6.10 Setting User Preferences ..........................................................................3-33 3.6.11 Adjusting Date and Time..........................................................................3-33
3.7 Installation Report ..................................................................................... 3-34 3.8 Moving, Transporting, and Storage ........................................................... 3-38
3.8.1 Moving the System within the Facility .......................................................3-38 3.8.2 Transporting the System.............................................................................3-38
Chapter 4: General Description
4.1 General Laser Theory .................................................................................. 4-1 4.2 CO2 Laser Theory ....................................................................................... 4-2 4.3 AcuPulse Laser System Description............................................................ 4-2 4.4 Control Panel ............................................................................................... 4-5
4.4.1 Optical Bench Assembly ...............................................................................4-6 4.4.2 Cooling System .............................................................................................4-7 4.4.3 Service Panel ................................................................................................4-7
4.5 Understanding Laser Delivery................................................................... 4-11
4.5.1 Exposure Types...........................................................................................4-11
4.6 Hardware and Software Interface .............................................................. 4-14
4.6.1 Software Description ..................................................................................4-14
4.7 System Specifications................................................................................ 4-15
4.7.1 4.7.2 4.7.3 4.7.4 4.7.5 4.7.6 Outputs .......................................................................................................4-15 Operation and Control ...............................................................................4-16 Cooling System ...........................................................................................4-17 Electrical Requirements .............................................................................4-17 Physical Specifications...............................................................................4-17 Environmental Specifications.....................................................................4-18
4.8 Delivery Systems & Accessories............................................................... 4-19
4.8.1 Standard Accessories .................................................................................4-20 4.8.2 Optional Accessories..................................................................................4-20
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Chapter 5: Functional Description
5.1 Introduction.................................................................................................. 5-1 5.2 CO2 Laser Tube........................................................................................... 5-2 5.3 HVPS & Bobbin Assembly ......................................................................... 5-2
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5.4 LVPS ........................................................................................................... 5-3 5.5 Interface/Controller Module ........................................................................ 5-4 5.6 Cooling System............................................................................................ 5-6
5.6.1 Air-Cooled Ventilation System .....................................................................5-6 5.6.2 Coolant-Cooled System ................................................................................5-7
5.7 Industrial PC ................................................................................................ 5-9 5.8 Touch Screen Display................................................................................ 5-10 5.9 Scanner Board............................................................................................ 5-10 5.10 Beam Delivery System - Articulated Arm................................................. 5-12
5.10.1 Articulated Arm Assembly ........................................................................5-12 5.10.2 Spring Balance Assembly .........................................................................5-13
5.11 Power Distribution..................................................................................... 5-15 5.12 Functional Description Lasing................................................................ 5-16 5.13 Internal Power Meter ................................................................................. 5-18 5.14 On Line Monitor ........................................................................................ 5-19
5.14.1 FPGA-DSP Safety ....................................................................................5-20
5.15 Software..................................................................................................... 5-22
5.15.1 User Mode ................................................................................................5-22 5.15.2 Service Mode ............................................................................................5-24 5.15.3 Main Service Screen Functions ................................................................5-28 5.15.4 Input / Output Screen ...............................................................................5-30 5.15.5 ADCs Screen.............................................................................................5-31 5.15.6 Power Meter Screen .................................................................................5-32 5.15.7 System Calibration Screen .......................................................................5-32 5.15.8 Error Log Screen......................................................................................5-33 5.15.9 System Screen ...........................................................................................5-34 5.15.10 Scanner Screen .......................................................................................5-35 5.15.11 FPGA Screen ..........................................................................................5-36
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Chapter 6: Scanners & Accessories
6.1 Introduction.................................................................................................. 6-1 6.2 SurgiTouch Functional Description............................................................. 6-2 6.3 AcuScan 120 Functional Description .......................................................... 6-3
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6.4 Scanner Calibration Procedures................................................................... 6-3 6.5 Accessories for AcuPulse Scanners............................................................. 6-5
Chapter 7: Calibrations, Alignments and Tests
7.1 Optical Alignments...................................................................................... 7-1
7.1.1 Alignment Procedures .................................................................................7-2 7.1.2 Alignment of the Aiming Beam Diode ..........................................................7-3 7.1.3 Combined Alignment Jig Assembly Description ..........................................7-3
7.2 Aiming Beam Diode Alignment Check/Procedure (Angular and Depth Alignment)7-4 7.3 CO2 Laser Tube Alignments ....................................................................... 7-8
7.3.1 CO2 Laser Alignment Check (Near and Far Field Tests)............................7-8 7.3.2 CO2 Laser Tube Alignment Procedure (Near and Far Alignments) ...........7-9
7.4 Articulated Arm Alignment....................................................................... 7-11
7.4.1 General.......................................................................................................7-11 7.4.2 Articulated Arm Alignment Check..............................................................7-13 7.4.3 Alignment of Mirrors No.1 through 4 ........................................................7-15
7.5 Structure of Mirror Assemblies No. 1 through 4....................................... 7-17
7.5.1 7.5.2 7.5.3 7.5.4 Angular Alignment Procedure for Mirror No. 1 ........................................7-18 Depth Alignment Procedure for Mirror No.1 ............................................7-20 Mirror No.2 Alignment Procedure.............................................................7-21 Mirror No.3 Alignment Procedure.............................................................7-21
7.6 Alignments with the Spring Balance System Activated............................ 7-22
7.6.1 Alignment of Mirror No. 4..........................................................................7-23
7.7 Post Alignment Articulated Arm Alignment Check.................................. 7-24 7.8 Rear Mirror Adjustment ............................................................................ 7-24 7.9 Calibration Procedures in Service Mode ................................................... 7-27
7.9.1 ADCS Calibration ......................................................................................7-27 7.9.2 Internal Power Meter Calibration .............................................................7-32
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7.9.3 System Calibration .....................................................................................7-39 7.9.4 Accessing the OS (Operating System) Explorer.........................................7-45 7.9.5 Touch Screen Calibration ..........................................................................7-47
7.10 Adjusting Date and Time........................................................................... 7-49 7.11 AcuPulse Software Upgrade...................................................................... 7-50
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7.12 AcuPulse Configuration Upgrade.............................................................. 7-50 7.13 Loading New Scanner Data ....................................................................... 7-52 7.14 Preventive Maintenance............................................................................. 7-55
Chapter 8: Troubleshooting
8.1 Introduction.................................................................................................. 8-1
8.1.1 Troubleshooting Guide Sections ..................................................................8-2
8.2 Troubleshooting Guide ................................................................................ 8-3
8.2.1 Error Messages ............................................................................................8-3
8.3 Description of the Error States .................................................................... 8-4
8.3.1 The Treatment of System Errors in Service mode ........................................8-4
8.4 Error Messages ............................................................................................ 8-6
8.4.1 Error # 01: Open Shutter Error ...................................................................8-6 8.4.2 Error # 02: Closed Shutter Error.................................................................8-7 8.4.3 Error # 04: Foot Switch 1/2 Error ...............................................................8-7 8.4.4 Error # 06: Foot Switch is Not Connected Error.........................................8-7 8.4.5 Error # 07: Foot Switch Pressed during Self Test Error .............................8-8 8.4.6 Error # 12: CO2 Cooling Flow Switch Error ..............................................8-8 8.4.7 Error # 13: CO2 PUMP Current (Velocity) Error ......................................8-8 8.4.8 Error # 14: Pump Status Error ....................................................................8-9 8.4.9 Error # 15: CO2 FAN Status Error..............................................................8-9 8.4.10 Error # 16: CO2 Temperature is more than 47ºC .....................................8-9 8.4.11 Error # 17: CO2 Over Temperature Error 50ºC .....................................8-10 8.4.12 Error # 18: Air FAN Status Error ............................................................8-10 8.4.13 Error # 19: System Air Temperature is more than 47º C.........................8-10 8.4.14 Error # 20: System Air Over Temperature Error.....................................8-11 8.4.15 Error # 23: Remote Interlock Error .........................................................8-11 8.4.16 Error # 24: Laser Stop Condition Error ..................................................8-12 8.4.17 Error # 26: HVPS Power Supply Fail Error............................................8-12 8.4.18 Error # 28: HVPS 110V Status Error ......................................................8-12 8.4.19 Error # 34: Parameters Error (Software)................................................8-13 8.4.20 Error # 35: GUI PC to DSP Micro Communication Error .....................8-13 8.4.21 Error # 36: DSP FPGA Communication Error .......................................8-14 8.4.22 Error # 37: FPGA Status NNNN Error....................................................8-14
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8.4.23 8.4.24 8.4.25 8.4.26 8.4.27 8.4.28 8.4.29 8.4.30 8.4.31 8.4.32 8.4.33 8.4.34 8.4.35 8.4.36 8.4.37 8.4.38 8.4.39 8.4.40 8.4.41 8.4.42 8.4.43 8.4.44 8.4.45 8.4.46 8.4.47 8.4.48 8.4.49 8.4.50 8.4.51 8.4.52 8.4.53 8.4.54 8.4.55 8.4.56
Error # 39: Offset Cal2 AGND/2.5V Error..............................................8-15 Error # 40: Offset Cal1 AGND/0.5V Error..............................................8-15 Error # 41: PS 5.0V Error........................................................................8-15 Error # 42: PS ±12V Error ......................................................................8-16 Error # 44: PS +24V Error......................................................................8-16 Error # 45: Power Meter SPDT1 Disk Error (HW).................................8-16 Error # 46: Power Meter SPDT2 Disk Error (HW).................................8-17 Error # 48: Power Meter Sanity Low Med 1W (Software) ......................8-17 Error # 49: Power Meter Sanity Med High 5W (Software) .....................8-18 Error # 50: CO2 On Line current 1 (HW) ...............................................8-18 Error # 51: Self Test Interlock Error .......................................................8-18 Error # 52: Self Test Laser Stop Button Error.........................................8-19 Error # 53: CO2On Line Monitor Current HW Compare Error .............8-19 Error # 54: Temperature Monitoring Error.............................................8-19 Error # 55: CO2 On line Limits SW Compare Error...............................8-20 Error # 56: Power Converge Error (SW) ................................................8-20 Error # 57: Self Test Power Out Test Error.............................................8-20 Error # 65: Scanner Fire Error ...............................................................8-21 Error # 66: Self Test Scanner DSP Controller Error ..............................8-21 Error # 68: Self Test Unsafe Scanner Disconnected Error......................8-21 Error # 69: Scanner Position X/Y Axis HW Error ...................................8-22 Error # 70: Scanner Disconnected Error.................................................8-22 Error # 71: Scanner Board Present Error ...............................................8-23 Error # 74: Scanner Position X Axis Error..............................................8-23 Error # 75: Scanner Position Y Axis Error..............................................8-24 Error # 76: Scanner PS ±15V Error ........................................................8-24 Error # 78: Scanner AcuBlade Error.......................................................8-24 Error # 79: Scanner Servo X/Y Axis not Calibrated Error ......................8-25 Error # 82: Scanner AcuBlade Switch Pressed Warning.........................8-25 Error # 300: HASP Not Connected Error................................................8-25 Error # 301: HASP Not Valid Error ........................................................8-26 Error # 302: Database Error ...................................................................8-26 Error # 303: Database Update Error ......................................................8-26 Error # 304: Software Error ....................................................................8-27
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8.5 Other System Problems ............................................................................. 8-27
8.5.1 8.5.2 8.5.3 8.5.4 8.5.5 8.5.6 8.5.7 No/Low Ignition of Laser ...........................................................................8-27 No Sound Emitted.......................................................................................8-27 Wrong Colors/Faulty Image/No Image on Display ...................................8-28 Touch-Screen Not Reacting as Expected....................................................8-28 Truncated or Misformed Shapes Created by Scanner................................8-28 Scanner "Whistling" ..................................................................................8-28 Cannot Login to the System........................................................................8-29
8.6 The FPGA Status Register Bits (from LSB to MSB) ................................ 8-32 8.7 System Operation after Error States in User Mode ................................... 8-32
8.7.1 System Footswitch Operating Error States ................................................8-33
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Chapter 9: Module Replacement
9.1 Introduction.................................................................................................. 9-1
9.1.1 Required Tools: ............................................................................................9-1
9.2 External Components Replacement............................................................. 9-2
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9.2.1 9.2.2 9.2.3 9.2.4 9.2.5 9.2.6 9.2.7
Front Cover Removal ...................................................................................9-2 Handle Replacement.....................................................................................9-4 Filters and Filter Covers Replacement ........................................................9-7 Front Filter Replacement .............................................................................9-7 Rear Filters and Filter Covers Replacement ...............................................9-7 Arm Clamps Replacement ............................................................................9-8 Cable Wrap Hooks Replacement................................................................9-10
9.3 Replacing the GUI PC ............................................................................... 9-11 9.4 Replacing the Display Assembly............................................................... 9-12 9.5 Replacing the Interface/Controller Assembly ........................................... 9-13 9.6 Replacing the Low Voltage Power Supply (LVPS) .................................. 9-15 9.7 Scanner Module Replacement ................................................................... 9-18 9.8 Replacing the High Voltage Power Supply ............................................... 9-20 9.9 Replacing the HVPS Bobbin ..................................................................... 9-23
9.9.1 Replacing the Air Pump Assembly .............................................................9-24
9.10 Replacing the Cooling System Modules ................................................... 9-26
9.10.1 9.10.2 9.10.3 9.10.4 9.10.5 Refilling the System with Fluorinert Coolant...........................................9-26 Replacing the Cooling Pump....................................................................9-27 Replacing the Expansion Tank .................................................................9-29 Replacing the Flow Switch .......................................................................9-30 Replacing the Heat Exchanger.................................................................9-30
9.11 Replacing the Optical Components ........................................................... 9-31
9.11.1 9.11.2 9.11.3 9.11.4 9.11.5 9.11.6 9.11.7 Replacing the Beam Delivery System (Articulated Arm) .........................9-31 Cleaning the Optical System ....................................................................9-33 Replacing the Aiming Beam Diode Module .............................................9-34 Replacing the Optical Bench ....................................................................9-35 Removing the CO2 Laser Tube ................................................................9-38 Installing the CO2 Laser Tube .................................................................9-39 Beam Combiner Assembly Replacement ..................................................9-41
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Chapter 10: Spare Parts Catalog
10.1 Introduction................................................................................................ 10-1 10.2 Spare Parts ................................................................................................. 10-2
10.2.1 10.2.2 10.2.3 10.2.4 10.2.5 10.2.6 10.2.7 Computer and Display..............................................................................10-4 Electronic Components ............................................................................10-5 Harnesses .................................................................................................10-6 Cooling System .........................................................................................10-7 Covers and Exterior Components ............................................................10-8 HVPS ......................................................................................................10-10 Optical Components ...............................................................................10-11
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10.3 Miscellaneous .......................................................................................... 10-12 10.4 Scanners and Accessories ........................................................................ 10-13 10.5 Special Tools ........................................................................................... 10-14
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LIST OF FIGURES
Chapter 1: Introduction Chapter 2: Safety
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Figure 2-1 Laser Treatment Room Warning Sign ................................. 2-3 Figure 2-2 System Safety Circuit......................................................... 2-11 Figure 2-3 System Labels ................................................................... 2-17
Chapter 3: Installation
Figure 3-1 Physical Dimensions ............................................................ 3-3 Figure 3-2 Shock Indicator Label .......................................................... 3-5 Figure 3-3 AcuPulse Shipping Box ....................................................... 3-6 Figure 3-4 Box Contents (For Illustration Purposes Only).................... 3-6 Figure 3-5 View of Top with Flaps Open.............................................. 3-7 Figure 3-6 Removing the Ramp from the Box ...................................... 3-7 Figure 3-7 Removing Top Cover with Foam......................................... 3-8 Figure 3-8 Removing Large Box Covering the Unit ............................. 3-8 Figure 3-9 Assembling the Ramp .......................................................... 3-9 Figure 3-10 Turning the Unit................................................................. 3-9 Figure 3-11 Opening the Base ............................................................. 3-10 Figure 3-12 Removing Foam Inserts ................................................... 3-11 Figure 3-13 Rolling the System Down the Ramp................................ 3-11 Figure 3-14 Remove the Plastic Wrapping.......................................... 3-12 Figure 3-15 Assembled AcuPulse Laser System ................................. 3-13 Figure 3-16 Smoke Evacuation Connection Port ................................ 3-14 Figure 3-17 Release the Articulated Arm ............................................ 3-16 Figure 3-18 125 mm Handpiece Set .................................................... 3-16 Figure 3-19 125 mm Handpiece Assembly ......................................... 3-17 Figure 3-20 Setting Up the SurgiTouch Scanner................................. 3-19 Figure 3-21 SurgiTouch Scanner with Accessory Assembled ............ 3-20 Figure 3-22 Footswitch Connection Port............................................. 3-22 Figure 3-23 Login Screen .................................................................... 3-24 Figure 3-24 Control Panel.................................................................... 3-25 Figure 3-25 Aiming Beam Check ........................................................ 3-28 Figure 3-26 Users List Screen ............................................................. 3-31 Figure 3-27 On-Screen Keyboard........................................................ 3-32 Figure 3-28 Preferences Screen ........................................................... 3-33
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Chapter 4: General Description
Figure 4-1 Figure 4-2 Figure 4-3 Figure 4-4 Figure 4-5 Figure 4-6 Figure 4-7 Figure 4-8 Figure 4-9 Assembled AcuPulse Laser System ..................................... 4-4 Control Panel........................................................................ 4-5 AcuPulse Treatment Screen (sample) .................................. 4-6 Service Panel....................................................................... 4-8 CW Exposure Types .......................................................... 4-12 Pulser Exposure Types....................................................... 4-13 SuperPulse Exposure Types............................................... 4-14 SurgiTouch Scanner Kit..................................................... 4-19 AcuScan 120 scanner Kit ................................................... 4-19
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Chapter 5: Functional Description
Figure 5-1 AcuPulse System Block Diagram ........................................ 5-1 Figure 5-2 HVPS & Bobbin Assembly Electrical Diagram .................. 5-3 Figure 5-3 LVPS Module Electrical Diagram ....................................... 5-4 Figure 5-4 Interface Board..................................................................... 5-5 Figure 5-5 Controller Board .................................................................. 5-6 Figure 5-6 Air Flow through AcuPulse System..................................... 5-7 Figure 5-7 Fluid Based Cooling Cycle for AcuPulse System ............... 5-8 Figure 5-8 Industrial PC Ports and Components ................................... 5-9 Figure 5-9 Touch Screen Display Assembly ....................................... 5-10 Figure 5-10 Scanner Module Electrical Diagram ................................ 5-11 Figure 5-11 SurgiTouch Scanner Head to Scanner Board Block Diagram ..................................................................................... 5-11 Figure 5-12 AcuScan 120 Scanner Head to Scanner Board Block Diagram ..................................................................................... 5-12 Figure 5-13 Articulated Arm Component Locations ........................... 5-14 Figure 5-14 Power Distribution Schematic ......................................... 5-15 Figure 5-15 Power Convergence Phase ............................................... 5-17 Figure 5-16 Lasing Phase Route .......................................................... 5-17 Figure 5-17 Internal Power Meter Functionality Diagram .................. 5-18 Figure 5-18 On Line Monitor .............................................................. 5-19 Figure 5-19 FPGA-DSP Safety Feature Block Diagram ..................... 5-20 Figure 5-20 Software States Diagram.................................................. 5-22 Figure 5-21 Treatment Screen ............................................................. 5-23 Figure 5-22 Home Screen .................................................................... 5-24 Figure 5-23 AcuPulse Splash Screen................................................... 5-25 Figure 5-24 Login Service Screen ....................................................... 5-25 Figure 5-25 Home Screen .................................................................... 5-26 Figure 5-26 Utilities Screen ................................................................. 5-26 Figure 5-27 Main Service Screen - Surgical Version (1.02) .............. 5-27 Figure 5-28 Main Service Screen - Aesthetic Version (1.04).............. 5-27 Figure 5-29 Self Test Screen ............................................................... 5-29 Figure 5-30 Input/Output Screen ......................................................... 5-30 Figure 5-31 ADCs Screen.................................................................... 5-31
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Figure 5-32 Figure 5-33 Figure 5-34 Figure 5-35 Figure 5-36 Figure 5-37
Power Meter Calibration Screen ...................................... 5-32 System Calibration Screen ............................................... 5-33 Error Log Screen .............................................................. 5-34 System Screen .................................................................. 5-35 Scanner Screen ................................................................. 5-36 FPGA Screen.................................................................... 5-37
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Chapter 6: Scanners & Accessories
Figure 6-1 Figure 6-2 Figure 6-3 Figure 6-4 Figure 6-5 SurgiTouch Scanner Head ................................................... 6-1 AcuScan 120 Scanner Head ................................................. 6-2 Scanner Board Location....................................................... 6-2 Utilities Screen ..................................................................... 6-4 New Scanner Upgrade Wizard............................................. 6-4
Chapter 7: Calibrations, Alignments and Tests
Figure 7-1 Articulated Arm Component Locations ............................... 7-2 Figure 7-2 Combined Alignment Jig Assembly .................................... 7-4 Figure 7-3 Combined Alignment Jig Assembly Connected for Aiming Beam Alignment........................................................................ 7-5 Figure 7-4 Alignment Beam Position on Masking Tape ....................... 7-5 Figure 7-5 Aiming Beam Diode Assembly ........................................... 7-6 Figure 7-6 Adjusting Screws ................................................................. 7-7 Figure 7-7 Beam Alignment Check Results .......................................... 7-9 Figure 7-8 Articulated Arm Components Locations ........................... 7-12 Figure 7-9 Arms Alignment Check Flow Chart .................................. 7-13 Figure 7-10 Alignment Jig Assembly in Elbow No.2 ......................... 7-18 Figure 7-11 Aiming Beam Position on Angle Window ...................... 7-19 Figure 7-12 aiming Beam Position on depth window ......................... 7-20 Figure 7-13 Mirror No.2 Alignment .................................................... 7-21 Figure 7-14 Mirror No.3 Alignment .................................................... 7-22 Figure 7-15 Alignment with End-Joint Holder and Adaptor ............... 7-24 Figure 7-16 Rear Mirror Metal Guard ................................................. 7-25 Figure 7-17 Rear Mirror Separator ...................................................... 7-25 Figure 7-18 Grounding the Rear Mirror .............................................. 7-26 Figure 7-19 ADCS Screen ................................................................... 7-27 Figure 7-20 ADCs Calibration Screen................................................. 7-28 Figure 7-21 Current Readings Calibration........................................... 7-30 Figure 7-22 Current Factor Calibration ............................................... 7-31 Figure 7-23 Current Limits Calibration ............................................... 7-32 Figure 7-24 Power Meter Screen -Offset Calibration.......................... 7-34 Figure 7-25 Main Service Screen ........................................................ 7-35 Figure 7-26 Power Meter Screen - Gain Calibration ........................... 7-35 Figure 7-27 Power Meter Screen ......................................................... 7-37 Figure 7-28 Power Meter 3 Calibration Screen ................................... 7-38 Figure 7-29 System Calibration - CW ................................................. 7-41
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Figure 7-30 Figure 7-31 Figure 7-32 Figure 7-33 Figure 7-34 Figure 7-35 Figure 7-36 Figure 7-37 Figure 7-38 Figure 7-39 Figure 7-40 Figure 7-41 Figure 7-42 Figure 7-43 Figure 7-44
System Calibration - SP - surgical version (1.02)............ 7-42 System Calibration - SP - Aesthetic Version (1.04) ........ 7-42 System Calibration Pulser SurgiTouch ............................ 7-43 System Calibration Pulser DeepFX ................................. 7-44 Login Service ................................................................... 7-45 Options Screen ................................................................. 7-46 Explorer Screen................................................................ 7-46 TPUtility.exe Icon ............................................................ 7-47 calibration Grid ................................................................ 7-48 9-Point Screen Calibration ............................................... 7-48 Free Draw Grid ................................................................ 7-49 Utilities Screen, Upgrade Button ..................................... 7-51 Software Upgrade ............................................................ 7-52 Utilities - New Scanner .................................................... 7-53 Scanner Upgrade Wizard ................................................. 7-54
Chapter 8: Troubleshooting
Figure 8-1 Figure 8-2 Figure 8-3 Figure 8-4 Figure 8-5 LVPS Voltage Lines Facing Outwards .............................. 8-29 COM Harness Location ..................................................... 8-30 Harness connector Not Fully Mounted .............................. 8-31 Harness Fully Closed ......................................................... 8-31 Switch Diagram - Footswitch ............................................ 8-34
Chapter 9: Module Replacement
Figure 9-1 Remove Six Allen Screws from Back.................................. 9-3 Figure 9-2 Holding Hooks ..................................................................... 9-3 Figure 9-3 Front Cover Open and Secured on Holding Hooks ............. 9-4 Figure 9-4 AcuPulse System Handles Location .................................... 9-4 Figure 9-5 Remove 4 Allen Screws ....................................................... 9-5 Figure 9-6 Screws Behind Laser Tube for Left Side Handle ................ 9-6 Figure 9-7 Filter Locations .................................................................... 9-7 Figure 9-8 Removing the Front Filter.................................................... 9-7 Figure 9-9 Filter Cover Screws.............................................................. 9-8 Figure 9-10 Arm Clamps Locations ...................................................... 9-9 Figure 9-11 Cable Wrap Hooks Location............................................ 9-10 Figure 9-12 Remove Screw ................................................................. 9-10 Figure 9-13 PC Module ....................................................................... 9-11 Figure 9-14 GUI PC Harnesses ........................................................... 9-12 Figure 9-15 Eight Screws Holding the Display Assembly .................. 9-12 Figure 9-16 Releasing Captive Screws on Interface/Controller .......... 9-14 Figure 9-17 Remove Guard Bracket from LVPS ................................ 9-15 Figure 9-18 Main Power Cable from LVPS ........................................ 9-16 Figure 9-19 disconnecting LVPS Control Cable ................................. 9-16 Figure 9-20 Disconnect from J1 .......................................................... 9-17 Figure 9-21 Remove Captive Screws from LVPS............................... 9-17
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Figure 9-22 Figure 9-23 Figure 9-24 Figure 9-25 Figure 9-26 Figure 9-27 Figure 9-28 Figure 9-29 Figure 9-30 Figure 9-31 Figure 9-32 Figure 9-33 Figure 9-34 Figure 9-35 Figure 9-36 Figure 9-37 Figure 9-38 Figure 9-39 Figure 9-40 Figure 9-41 Figure 9-42 Figure 9-43 Figure 9-44 Figure 9-45 Figure 9-46 Figure 9-47 Figure 9-48 Figure 9-49 Figure 9-50 Figure 9-51 Figure 9-52 Figure 9-53 Figure 9-54 Figure 9-55 Figure 9-56 Figure 9-57 Figure 9-58
Disconnect HV Connections ............................................ 9-18 Scanner Module Connections .......................................... 9-19 Disconnect 110V Power Cable ........................................ 9-20 Release the HVPS Captive Screws .................................. 9-21 Disconnect HV Connectors.............................................. 9-21 Disconnect Bobbin Cable................................................. 9-22 Disconnect HVPS Control Harness ................................. 9-22 Removing HVPS from Mounting Plate ........................... 9-23 Remove Nuts from Mounting Plate ................................. 9-24 Open Bottom Panel .......................................................... 9-24 Disconnect Connections to Air Pump .............................. 9-25 Air Pump Bottom ............................................................. 9-25 Release Air Pump Quick-Connector................................ 9-26 Cooling Pump .................................................................. 9-28 Tie off Coolant Tubes ...................................................... 9-28 Release Screws Holding Pump ........................................ 9-28 Disconnect Tube to Expansion Tank ............................... 9-29 Release Screws Holding Expansion Tank ....................... 9-29 Flow Switch Removal ...................................................... 9-30 Release Screws on Heat Exchanger ................................. 9-31 Rotate the Arm on its Base to Access Hole ..................... 9-32 Disconnect Air Purge Tube.............................................. 9-32 Mounting the Arm............................................................ 9-33 Ground Bracket ................................................................ 9-35 Cooling Fluid Tube from Flow Switch ............................ 9-35 .......................................................................................... 9-36 Diode Harness .................................................................. 9-36 Harness on Beam Combiner ............................................ 9-37 Chassis Bolts - Upper and Lower .................................... 9-37 Remove Anti-static Foam ................................................ 9-38 Remove 2 Securing Screws.............................................. 9-39 Laser Tube Installation - Front Mirror ............................. 9-39 Installing the Laser Tube.................................................. 9-40 Fixing Pins Aligned ......................................................... 9-40 Insert Mirror in Dust Sleeve of Beam Combiner ............. 9-41 Disconnect Coolant Tube on Beam Combiner ................ 9-41 Releasing 2 Nuts on Beam Combiner .............................. 9-41
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Chapter 10: Spare Parts Catalog
Figure 10-1 Spare Parts List Example ................................................. 10-2 Figure 10-2 System Front View........................................................... 10-3 Figure 10-3 Computer and Display ..................................................... 10-4 Figure 10-4 Electronic Components .................................................... 10-5 Figure 10-5 Harnesses ......................................................................... 10-6 Figure 10-6 Cooling System Components........................................... 10-7 Figure 10-7 Covers and Exterior Components .................................... 10-8 Figure 10-8 HVPS ............................................................................. 10-10 Figure 10-9 Optical Components....................................................... 10-11 Figure 10-10 Miscellaneous............................................................... 10-12 Figure 10-11 Scanners and Accessories ............................................ 10-13 Figure 10-12 Special Tools................................................................ 10-14
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INTRODUCTION
1.1 Introduction
The AcuPulse encompasses a family of DC-excited CO2 laser system models for use in a variety of surgical and aesthetic applications. · AcuPulse 30 · AcuPulse 40 · AcuPulse 30ST - this system includes software and operating modules for the Lumenis SurgiTouch Flashscanner accessories · AcuPulse 40ST - this system includes software and operating modules for the Lumenis SurgiTouch Flashscanner accessories · AcuPulse 40R - this system includes software and operating modules for the Lumenis resurfacing kit, including the SurgiTouch flashscanner. · AcuPulse 40F - this system includes software and operating modules for the Lumenis AcuScan 120 fractional flashscanner accessories. · AcuPulse 40A - this system includes software and operating modules for the Lumenis AcuScan 120 fractional flashscanner accessories and the Lumenis resurfacing kit, including the SurgiTouch flashscanner.
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The AcuPulse systems deliver maximal power of:
System Model: 30, 30ST 40, 40ST, 40R, 40F, 40A
Continuous Wave Pulser Mode SuperPulse Mode
30 Watts 25 Watts 10 Watts
40 Watts 35 Watts 15 watts
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1.2 Characteristics of the CO 2 Laser Beam
The CO2 laser wavelength falls in the mid-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye. 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.
1.3 Scope of This Manual
Caution
Service personnel operating or maintaining the AcuPulse system should read this manual thoroughly before attempting to operate or service the device. While the manual is intended to aid the service personnel in the care and service of the equipment, it cannot serve as a substitute for the service engineers training, provided by Lumenis.
This service manual incorporates the following chapters:
Chapter 1: Chapter 2: Introduction Safety Contains a general introduction to the system. Contains explanations and directions concerning safety measures for operating the system. This chapter also includes regulatory information and requirements.
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Chapter 3:
System Installation
Lists electrical, space and environmental requirements for system installation and instructions for unpacking, installing and testing the system. Contains a detailed overview of the system and its various components, controls, displays and connections. Includes detailed specifications of all facets of the system. Provides a detailed functional description of all unit sub-systems and software. Provides information regarding the AcuPulse optional scanners and accessories, including the SurgiTouch and AcuScan 120 flashscanners Contains instructions on various system tests and calibrations, and provides a preventive maintenance check list.
Chapter 4:
System Description
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Chapter 5: Chapter 6:
Functional Description Scanners and Accessories
Chapter 7:
Tests, Calibrations & Preventive Maintenance
Chapter 8:
Troubleshooting Lists the system error messages and various problems, probable causes, symptoms/ diagnostic checks, and the appropriate corrective actions Module Replacement Provides instructions for replacement of the unit's modules and assemblies. The instructions include removal, installation and post- replacement procedures. Provides an easy-to-use catalog, containing photographs of the unit and its components.
Chapter 9:
Chapter 10: Spare Parts
1.4 Manual Conventions
Throughout this manual, notes, cautions and warnings 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.
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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.
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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.
1.5 Applicable Documents
AcuPulse System (Surgical) Operator Manual (P/N # UM-1053720) AcuPulse System (Aesthetic) Operator Manual (P/N # UM-1061050)
1.6 Abbreviations and Acronyms
" °C °F ACD ANSI CE cm CO2 CVD CW DAC DC DSP ENT Inches Degrees Celsius Degrees Fahrenheit Analog to Digital conversion American National Standards Institute European Directives Compliance Marking Centimeters Carbon Dioxide Continuous Variable Defocus Continuous Wave Digital to Analog Conversion Direct Current Digital Signal Processor Ear, Nose and Throat
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FDA FPGA FSE GI GUI GYN
Food & Drug Administration (USA) Field Programmable Gate Array Field Service Engineer Gastro-intestinal Graphic User Interface Gynecology High Voltage Power Supply Hertz International Electrotechnical Commission International Standards Organization Joules per square centimeter Kilogram Pounds Laser-Assisted Myringotomy Local Area Network Laser-Assisted Uvulopalatoplasty Liquid Crystal Display Light Emitting Diode Low Voltage Power Supply Meters MilliJoules Millimeters MilliWatts National Electrical Manufacturers Association Nanometers Optical Density Part Number Power Supply Serial Number SuperPulse Underwriters Laboratories Universal Serial Bus Volts, Alternating Current Video graphics Array Watts
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HVPS Hz IEC ISO J/cm2 kg lbs LAM LAN LAUP LCD LED LVPS m mJ mm mW NEMA nm OD P/N PS S/N SP UL USB VAC VGA W
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SAFETY
2.1 Introduction
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 AcuPulse system must be thoroughly familiar with all its safety requirements and operating procedures.
Likewise, the service technician must become familiar with all safety precautions before attempting to check the interior of the unit. The laser unit generates high voltages and emits laser radiation of high intensity which can cause serious personal injury if handled improperly. This chapter includes: · Laser Safety guidelines · Understanding and Controlling Laser Impact on Tissue · Hazards associated with Unsafe Laser Use · System Safety Features · Compliance with International Standards · Warning, Certification, and Identification Labels
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2.2 Laser Safety Guidelines
American National Standards Institute specification ANSI Z136.32005 and Z136.1-2000 include a very thorough discussion of laser safety and guidelines for medical laser use. These standards were developed in the earliest days of lasers and are routinely revised to keep up with growing technology. ANSI Z136.3 is written specifically for the use of lasers in medicine. While non-binding, the guidelines are excellent guides for an office or institution seeking to set up a formal safety program. Lumenis strongly recommends that the operators read these two ANSI standards before using a laser in clinical practice.
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2.2.1 Laser Safety Officer
Large institutions are following the prescriptions of ANSI 136.3 by setting up Laser Safety Committees and appointing Laser Safety Officers to manage laser use. Even the smallest office should have one person to act in the capacity of Laser Safety Officer. ANSI Z136.3 requires the Laser Safety Officer to fulfill the following responsibilities: 1. Classify, or verify classification of, lasers and laser systems. 2. Evaluate hazards of laser treatment areas. 3. Assure that the prescribed control measures are in effect and recommend or approve alternates when the primary ones are not feasible. 4. Approve operational procedures, including any procedural checklists. 5. Recommend or approve protective equipment, and assure that it is periodically inspected to ensure proper working order. 6. Approve wording on signs and equipment labels. 7. Approve installation and equipment prior to use, and modifications to existing equipment and facilities. 8. Assure adequate safety education and training is provided for all personnel. The Laser Safety Officer may also assume other responsibilities, such as keeping laser use and preventive maintenance logs. The Laser Safety Officer should become familiar with the periodic preventive maintenance requirements in the preventive maintenance chapter of this manual.
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2.2.2 Laser Treatment/Operating Area
According to ANSI Z136.3, the Laser Safety Officer is responsible for the area in which laser treatments are carried out. In meeting this requirement, the Laser Safety Officer should ensure that: 1. The surroundings are safe for both the patient and the operator.
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2. The floor is uncluttered and clear access is maintained to the footswitch. Cables are secure and not crimped. 3. The operating area is occupied only by authorized personnel. 4. Appropriate warning signs are posted in the operating area and just outside of it. The AcuPulse is a Class IV laser; the door warning sign for the AcuPulse is shown in Figure 2-1.
VISIBLE AND INVISIBLE LASER RADIATION
Avoid eye or skin exposure To direct or scattered radiation.
LASER SURGERY IN PROGRESS SAFETY EYEWEAR REQUIRED
CO 2 LASER/10600nm Diode LASER/635nm 40 Watts Continuous CLASS 4/IV LASER 5 mWatts Continuous CLASS 3A/IIIa LASER
Figure 2-1 Laser Treatment Room Warning Sign
2.3 Understanding and Controlling Laser Impact on Tissue
Caution
The AcuPulse system contains a Class IV, CO2 laser which produces an invisible beam of high energy infrared radiation. Improper use could result in serious personal injury. Observe all safety precautions for Class IV lasers.
Many different types of lasers have been developed for multitudes of different uses. Each type of laser has a certain potential for harm if
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misused. Even lasers designed for use on living tissue must be used and applied carefully in order to avoid: · Hazards to the patient or clinical personnel · Hazards to the physical surroundings For this reason, it is important to understand the basics of how laser energy affects living tissue and how to control this energy so as to avoid misapplication. The tissue damage that a misused laser may do depends on the following factors: · · · ·
Class of the laser Wavelength of the laser Tissue variability of the area in contact with Spot size or beam diameter · Power