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, SurgiTouch, AcuScan120, Pulser, SuperPulse, AcuSpot 712,
Digital AcuBlade, OtoLAM, StretchTouch, ToeTouch, FineTouch, FeatherTouch, SilkTouch and
BeamAlign are trademarks or registered trademarks of Lumenis.
In the USA –
Caution: US federal law restricts this device to sale by or on the order of a physician.

Copyright © 2014, Lumenis Ltd.

Catalog Part Number: UM-1091300
September 2014
Revision F

Use of this Manual:

The AcuPulse 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 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 information@Lumenis.com
Authorized Representative in the European Community:
Lumenis (Germany) GmbH
Heinrich-Hertz-Str. 3
D-63303Dreieich-Dreieichenhain
Germany
Tel: +49 (0) 6103-8335-0

Manufactured by Lumenis Ltd.

6 Hakidma Street
P.O.B. 240
Yokneam 2069204, Israel
Tel: +972-4-959-9000

Directive 2012/19/EC on Waste Electrical and Electronic Equipment (WEEE)

In accordance with Directive 2012/19/EC 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.
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AcuPulse Table of Contents

Table of Contents
CHAPTER 1 Overview Page

1.1. Introduction ........................................................................................................................................ 1-1

1.2. Characteristics of the CO2 Laser Beam.............................................................................................. 1-1
1.3. Laser Preparation ............................................................................................................................... 1-2
1.4. Scope of This Manual ........................................................................................................................ 1-2
1.5. Manual Conventions .......................................................................................................................... 1-4
1.6. Physician Responsibility .................................................................................................................... 1-4
1.7. Maintenance ....................................................................................................................................... 1-4
1.8. Modification of the Device ................................................................................................................ 1-5
1.9. Resale Inspection ............................................................................................................................... 1-5
1.10. Abbreviations and Acronyms ............................................................................................................ 1-5

CHAPTER 2 Laser Safety Page

2.1. Introduction ........................................................................................................................................ 2-1

2.2. 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 ........................................................................................................................ 2-7
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. Password Protection .................................................................................................................. 2-18
2.9.2. Self Testing at Start Up ............................................................................................................. 2-18
2.9.3. Safety Shutter ............................................................................................................................ 2-18
2.9.4. Door Interlock Connector .......................................................................................................... 2-18
2.9.5. Safety Interlocks and Failsafes .................................................................................................. 2-18
2.9.5.1. Dual-Footswitch Microswitch....................................................................................... 2-18
2.9.5.2. Laser Stop Button.......................................................................................................... 2-19
2.9.5.3. Shutter Position Failsafe ............................................................................................... 2-19
2.9.5.4. Power Measurement Failsafe ........................................................................................ 2-19
2.9.6. Safety Timer .............................................................................................................................. 2-19
2.9.7. Continuous Internal System Monitoring ................................................................................... 2-19
2.9.7.1. System Faults ................................................................................................................ 2-19
2.9.7.2. Internal Power Monitoring ............................................................................................ 2-19
2.9.7.3. Temperature .................................................................................................................. 2-19
2.9.8. Laser Beam Emission Indicators ............................................................................................... 2-20
2.10. Compliance with International Standards ........................................................................................ 2-20
2.11. Warning, Certification and Identification Labels ............................................................................ 2-21

CHAPTER 3 System Installation Page

3.1. Introduction ........................................................................................................................................ 3-1

3.2. Unpacking the System ....................................................................................................................... 3-1
3.3. 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. Service Panel Connections .......................................................................................................... 3-6
3.5. Initial System Testing ........................................................................................................................ 3-7
3.5.1. System Controls .......................................................................................................................... 3-7
3.5.2. Main Control Panel ..................................................................................................................... 3-7
3.5.3. System Start Up ........................................................................................................................... 3-7
3.5.4. Door Interlock Check .................................................................................................................. 3-8
3.5.5. Footswitch Connection Check..................................................................................................... 3-8
3.5.6. Laser Stop Button Check ............................................................................................................. 3-9
3.6. Moving, Transporting and Storage .................................................................................................... 3-9

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3.6.1. Moving the System within the Facility ....................................................................................... 3-9

3.6.2. Transporting the System .............................................................................................................. 3-9

CHAPTER 4 System Description Page

4.1. General Laser Theory ........................................................................................................................ 4-1
4.2. CO2 Laser Theory .............................................................................................................................. 4-1
4.3. AcuPulse Laser System...................................................................................................................... 4-2
4.4. System Description ............................................................................................................................ 4-2
4.4.1. Control Panel ............................................................................................................................... 4-5
4.4.2. Optical Bench Assembly ............................................................................................................. 4-6
4.4.3. Cooling System ........................................................................................................................... 4-7
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 .............................................................................................. 4-8
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 ......................................................................................................................... 4-15
4.6.4. Electrical Requirements ............................................................................................................ 4-15
4.6.5. Physical Specifications .............................................................................................................. 4-16
4.6.6. Environmental Specifications.................................................................................................... 4-16
4.6.7. System Classifications ............................................................................................................... 4-16

CHAPTER 5 Operating Instructions Page

5.1. Introduction ........................................................................................................................................ 5-1
5.2. Safety Considerations ........................................................................................................................ 5-1
5.3. Starting the System ............................................................................................................................ 5-2
5.3.1. Before Turning On the System .................................................................................................... 5-2
5.4. Operating the System ......................................................................................................................... 5-2
5.5. SurgiTouch Treatment ....................................................................................................................... 5-5

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5.5.1. Select Specialty ........................................................................................................................... 5-5

5.5.2. SurgiTouch Menu ........................................................................................................................ 5-6
5.5.3. Treatment Screen: Scan Mode..................................................................................................... 5-7
5.5.4. Treatment Screen: No Scan Mode............................................................................................. 5-11
5.6. Manual Treatment ............................................................................................................................ 5-12
5.7. Aesthetic Treatments ....................................................................................................................... 5-13
5.7.1. Fractional Applications ............................................................................................................. 5-15
5.8. User Presets...................................................................................................................................... 5-17
5.8.1. Programming User Presets ........................................................................................................ 5-17
5.8.2. My Settings ............................................................................................................................... 5-18
5.8.3. Fix Settings ................................................................................................................................ 5-19
5.9. Atlas of Accessories ......................................................................................................................... 5-20
5.10. Preferences ....................................................................................................................................... 5-21
5.10.1. General Preferences .............................................................................................................. 5-21
5.10.2. Air Flow Preferences ............................................................................................................ 5-23
5.10.3. Sound Preferences ................................................................................................................. 5-24
5.11. Utilities Menu .................................................................................................................................. 5-25
5.11.1. Disconnecting the Scanner .................................................................................................... 5-26
5.11.2. Installing a New Scanner ...................................................................................................... 5-27
5.11.3. Users List .............................................................................................................................. 5-28
5.11.3.1. Add User ....................................................................................................................... 5-29
5.11.3.2. Edit User ....................................................................................................................... 5-30
5.11.4. Database Backup ................................................................................................................... 5-31
5.12. System Messages ............................................................................................................................. 5-32
5.13. System Shut-Down .......................................................................................................................... 5-32

CHAPTER 6 Delivery Systems Page

6.1. Introduction ........................................................................................................................................ 6-1
6.2. 125mm Incisional Handpiece Set ...................................................................................................... 6-1
6.2.1. Handpiece Assembly ................................................................................................................... 6-1
6.3. FeatherTouch Handpiece Set ............................................................................................................. 6-2
6.4. Scanning Accessories......................................................................................................................... 6-2
6.4.1. SurgiTouch Scanner Kit Contents ............................................................................................... 6-3
6.4.2. Scanning Accessories Operator Manuals .................................................................................... 6-3
6.4.3. Setting up a Scanning Accessory System .................................................................................... 6-4
6.4.4. Cleaning the Optical Heads ......................................................................................................... 6-5
6.5. Beam Alignment Check ..................................................................................................................... 6-5
6.6. Optional Accessories ......................................................................................................................... 6-7

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6.7. Cleaning, Sterilization and High-level Disinfection .......................................................................... 6-8

6.7.1. General ........................................................................................................................................ 6-8
6.7.2. Deciding on Sterilization or High-level Disinfection .................................................................. 6-8
6.7.3. Repeated Sterilization or High-level Disinfection .................................................................... 6-10
6.7.4. Cleaning Procedure ................................................................................................................... 6-10
6.7.5. Sterilization Techniques ............................................................................................................ 6-11
6.7.6. High-level Disinfection Techniques .......................................................................................... 6-11

CHAPTER 7 Maintenance Page

7.1. Introduction ........................................................................................................................................ 7-1
7.2. Service Information ........................................................................................................................... 7-1
7.3. Routine Periodic Maintenance ........................................................................................................... 7-2
7.4. Lumenis Service ................................................................................................................................ 7-3
7.5. 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 ................................................................................................................. 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

CHAPTER 8 Troubleshooting Page

8.1. Introduction ........................................................................................................................................ 8-1
8.2. Warranty ............................................................................................................................................ 8-1
8.3. Hazard Precautions ............................................................................................................................ 8-1
8.4. Troubleshooting Guides ..................................................................................................................... 8-1
8.5. Scanner Position Error ....................................................................................................................... 8-5

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APPENDIX A Clinical Guide: Surgical Applications 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
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

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A.13. References .......................................................................................................................................... A-13

APPENDIX B Clinical Guide: Aesthetic Applications Page

B.1. Introduction ............................................................................................................................................ B-1
B.2. Indications for Use ................................................................................................................................. B-1
B.3. General Contraindications ...................................................................................................................... B-2
B.4. Dermatology and Plastic Surgery Contraindications ............................................................................. B-3
B.5. General Laser Recommendations ........................................................................................................... B-3
B.6. General Laser Safety Considerations ..................................................................................................... B-3
B.7. Dermatology/Plastic Surgery (Aesthetic) ............................................................................................... B-4
B.7.1. Dermatology/ Plastic Surgery Indications ............................................................................. B-4
B.7.2. Dermatology and Plastic Surgery Contraindications ............................................................. B-5
B.7.3. Safety Considerations for Dermatology and Plastic Surgery ................................................. B-5
B.7.4. Complications, Expected Side Effects and Immediate Responses ........................................ B-6
B.8. Patient Care and Treatment Recommendations ..................................................................................... B-8
B.8.1. Pre-Operative Care ................................................................................................................. B-9
B.8.2. Post-Operative Care ............................................................................................................. B-10
B.9. Adverse Event Management ................................................................................................................ B-11
B.10. References .......................................................................................................................................... B-12

APPENDIX C EMC Guidance and Manufacturer's Declaration Page

C.1. Electromagnetic Emissions .................................................................................................................... C-1
C.2. Electromagnetic Immunity ..................................................................................................................... C-2
C.3. Recommended Separation Distances ..................................................................................................... C-4

List of Illustrations
Figure 2-1: Laser Treatment Room Warning Sign ......................................................................................... 2-3
Figure 2-2: System Labels ............................................................................................................................ 2-22
Figure 3-1: Physical Dimensions .................................................................................................................... 3-2
Figure 3-2: Assembled AcuPulse Laser System ............................................................................................. 3-4
Figure 3-3: Release the Articulated Arm ........................................................................................................ 3-5
Figure 3-4: Service Panel ................................................................................................................................ 3-6
Figure 3-5: Control Panel................................................................................................................................ 3-8
Figure 4-1: AcuPulse System Description ...................................................................................................... 4-4

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Figure 4-2: Control Panel................................................................................................................................ 4-5

Figure 4-3: AcuPulse Treatment Screen (sample) .......................................................................................... 4-6
Figure 4-4: Service Panel ................................................................................................................................ 4-7
Figure 4-5: CW Exposure Types .................................................................................................................. 4-10
Figure 4-6: Pulser Exposure Types ............................................................................................................... 4-11
Figure 4-7: SuperPulse Exposure Types ....................................................................................................... 4-12
Figure 5-1: Login Screen ................................................................................................................................ 5-3
Figure 5-2: Home Screen ................................................................................................................................ 5-3
Figure 5-3: Select Specialty Screen ................................................................................................................ 5-5
Figure 5-4: SurgiTouch Menu Screen – ENT ................................................................................................. 5-6
Figure 5-5: SurgiTouch Treatment Screen – Scan Mode................................................................................ 5-7
Figure 5-6: SurgiTouch Treatment Screen – No Scan Mode ........................................................................ 5-11
Figure 5-7: Treatment Screen – Manual Settings ......................................................................................... 5-12
Figure 5-8: Aesthetics Menu Screen ............................................................................................................. 5-13
Figure 5-9: Aesthetics Treatment Screen ...................................................................................................... 5-14
Figure 5-10: Aesthetics Treatment Screen: Deep, Superficial, Combo and StretchTouch ........................... 5-15
Figure 5-11: Add Settings Screen ................................................................................................................. 5-17
Figure 5-12: My Settings Screen .................................................................................................................. 5-18
Figure 5-13: SurgiTouch Presets Screen ....................................................................................................... 5-19
Figure 5-14: Atlas of Accessories Screen ..................................................................................................... 5-20
Figure 5-15: General Preferences Screen...................................................................................................... 5-21
Figure 5-16: Air Flow Preferences Screen .................................................................................................... 5-23
Figure 5-17: Sound Preferences Screen ........................................................................................................ 5-24
Figure 5-18: Utilities Menu Screen ............................................................................................................... 5-25
Figure 5-19: Disconnect Scanner Pop-Up Message...................................................................................... 5-26
Figure 5-20: New Scanner Upgrade Pop-Up ................................................................................................ 5-27
Figure 5-21: Users List Screen...................................................................................................................... 5-28
Figure 5-22: Add User Screen ...................................................................................................................... 5-29
Figure 5-23: Edit User Screen....................................................................................................................... 5-30
Figure 5-24: Database Backup Screen .......................................................................................................... 5-31
Figure 6-1: 125mm Incisional Handpiece ...................................................................................................... 6-1
Figure 6-2: SurgiTouch Beam Scanning Pattern ............................................................................................ 6-3
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) ............................................................................... 8-5

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 Chapter 1
Overview

1.1. Introduction AcuPulse encompasses a family of DC-excited CO2 laser system models
for use in a variety of surgical and aesthetic applications:
1. AcuPulse 30 – CO2 laser system (30 Watts) with Manual operating
mode.
2. AcuPulse 30ST – CO2 laser system (30 Watts) with Manual and
SurgiTouch operating modes.
3. AcuPulse 40 – CO2 laser system (40 Watt) with Manual operating
mode.
4. AcuPulse 40ST – CO2 laser system (40 Watts) with Manual and
SurgiTouch operating modes.
5. AcuPulse 40AES-F – CO2 laser system (40 Watts) with Manual and
Aesthetic operating modes (Fractional Resurfacing).
6. AcuPulse 40AES-R – CO2 laser system (40 Watts) with Manual and
Aesthetic operating modes (Fractional and Conventional Resurfacing).
7. AcuPulse 40AES-A – CO2 laser system (40 Watts) with Manual,
SurgiTouch and Aesthetic operating modes (Fractional and
Conventional Resurfacing).

The AcuPulse systems deliver maximal power of:

System Power:  30 Watt System 40 Watt System
Continuous Wave Mode 30 Watts 40 Watts
Pulser Mode 25 Watts 35 Watts
SuperPulse Mode 10 Watts 15 watts

1.2. Characteristics of The CO2 laser wavelength falls in the mid-infrared region of the
the CO2 Laser electromagnetic spectrum. This wavelength is invisible to the human eye.
Beam
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.

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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 in-
service training to ensure that your staff is experienced with the operation
and safety considerations of the laser.

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 This manual is intended to provide the surgeon and other personnel who
Manual 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:

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.

Chapter 3: System Lists electrical, space and environmental

Installation requirements for installation of the
system and basic installation
instructions.

Chapter 4: System Contains a detailed overview of the

Description system and its various components,
controls, displays and connections.
Includes detailed specifications of all
facets of the system.

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Chapter 5: Operating Explains how to operate the system.

Instructions

Chapter 6: Delivery Systems Describes the various delivery systems

used with the AcuPulse.

Chapter 7: Maintenance Provides a detailed review of how to

maintain the system.

Chapter 8: Troubleshooting Lists the system's error messages that

might occur during operation, their
probable causes and what actions to
take.

Appendix A: Clinical Guide: Offers information about staff training,

Surgical indications and contraindications for
Applications use, recommended setup parameters and
suggested professional reference
literature.

Appendix B: Clinical Guide: Offers information about staff training,

Aesthetic indications and contraindications for
Applications use, recommended setup parameters and
suggested professional reference
literature.

Appendix C: EMC Guidance Describes the electromagnetic

environment in which the system may be
operated.

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Overview AcuPulse

1.5. Manual Throughout this manual, notes, cautions and warnings and are used to
Conventions 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 Federal (USA) law restricts prescription medical devices to sale by or on
Responsibility 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 The AcuPulse 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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AcuPulse Overview

1.8. Modification of the Unauthorized modification of the hardware, software or specifications of

Device the AcuPulse 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 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 " Inches

Acronyms °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
Hz Hertz
IEC International Electrotechnical Commission

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Overview AcuPulse

ISO International Standards Organization

2
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

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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 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.
• Notes, precautions, cautions and warnings associated with the
AcuPulse.

2.2. Training and Caution

Institutional
No one should use the AcuPulse, or any other medical laser,
Requirements 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.

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2.2.1. Laser Safety American National Standards Institute specification ANSI Z136.3-2005
Guidelines 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.

2.2.2. Laser Safety Large institutions are following the prescriptions of ANSI 136.3 by setting
Officer 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
keeping laser use and maintenance logs. The Laser Safety Officer should
become familiar with the periodic maintenance requirements in the
Maintenance chapter of this manual.

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2.2.3. Laser Treatment/ According to ANSI Z136.3, the Laser Safety Officer is responsible for the
Operating Area 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.

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.

Figure 2-1: Laser Treatment Room Warning Sign

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Laser Safety AcuPulse

2.3. Understanding and Warning

Controlling Laser
The AcuPulse system contains a Class IV, CO2 laser which
Impact on Tissue 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
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 a laser beam
• Spot size or beam diameter
• Power
• Exposure, or time duration of beam contact

The following sections describe these factors in more detail.

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2.3.1. Laser Classes Lasers are divided into classes by power according to the degree of safety
hazards they present (see Table 2-1).

The AcuPulse is a Class IV laser and is therefore potentially

hazardous to both patient and operator.

Table 2-1: Laser Classes

Laser Class Example Characteristics

Class I Grocery store Class I lasers do not emit levels of optical

scanner radiation above the exposure limits for the
eye under any circumstances - they are no
more harmful than an electric light bulb.
Class II Laser pointer Momentary viewing of Class II lasers is not
considered dangerous.
Class III Laser light Class III lasers may be hazardous for direct
show viewing.
Class IV Most surgical Class IV includes all lasers that exceed over
lasers 0.5 Watt average power over 0.25 seconds
or those that exceed 10 J/cm2. They can
cause serious eye and skin injuries and set
fire to many materials. Both the direct and
reflected beams are hazardous to the eye
and skin.

2.3.2. Wavelength and Different types of lasers generate different wavelengths of light. When
Tissue Variability laser energy strikes tissue, the laser wavelength and the target tissue type
determine the basic nature of the impact.

Lasers of different wavelengths show different effects on a given type of

tissue. Conversely, a laser of a given wavelength affects different types of
tissue in different ways. The primary factor is the efficiency with which
the tissue absorbs light of the given wavelength.

An example that illustrates this concept is the use of the Argon laser for
retinal surgery. The Argon laser is used for retinal surgery because the
tissues and fluids in front of the retina do not absorb the Argon laser
wavelength, whereas the retina itself does. By comparison, the CO2 laser
wavelength would be totally absorbed by the lens and would damage it
before reaching the retina.

The AcuPulse is a CO2 laser. The CO2 emits a concentrated beam of light
at a wavelength of 10.6 microns, which is in the invisible infrared portion
of the electromagnetic spectrum. The effects, and therefore the risks, of the
CO2 laser are primarily thermal.

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Light at the CO2 laser wavelength is efficiently absorbed by water, the

primary component of soft tissue. When the laser beam strikes soft tissue,
its energy is absorbed by water in the tissue. The water heats up, boils, and
vaporizes, taking the surrounding tissue with it. CO2 laser energy is
effectively absorbed by all soft tissue, regardless of the pigmentation.

The effect of the CO2 laser on tissue is further discussed in the Clinical
Guide chapters of this manual.

Note that the CO2 laser beam can also damage bone or teeth, causing
pitting, glazing and explosive separation.

2.3.3. Spot Size, Power Assuming that the laser wavelength and target tissue are given, the spot
and Exposure size, power, and exposure (including exposure duration) determine the
laser's degree of impact.

The operator sets the power in Watts with the laser controls. Note the
relationship of spot size and power: at a given power setting, a larger spot
size spreads the power out over a larger area. This yields a larger area of
impact, but a lesser tissue effect.

The operator controls the exposure with the laser controls. The exposure
determines the duration of the applied laser beam. Obviously, the longer
the exposure is, the greater the tissue impact will be. The primary exposure
control is the footswitch.

The AcuPulse system's modes of operation are based on two distinct types
of settings: the laser operation mode and the tissue exposure mode settings.
The laser operation modes control the power pattern and the peak power
outputs, while the tissue exposure modes control the duration pattern of the
laser beam delivered to tissue

The system offers three laser operation modes and three tissue exposure
modes:
Laser Operation Modes Tissue Exposure Modes
1. Continuous Wave (CW) 1. Continuous
2. SuperPulse 2. Single Pulse
3. Pulser 3. Repeat Pulse

The clinician uses spot size or scan shape & size, power, depth, operation
mode and exposure mode to control the interaction of the AcuPulse's laser
beam, and its attendant thermal effects, on the patient’s tissue. Safe and
effective use of the laser in clinical procedures comes with a mix of
clinical training, mentoring and experience. A more complete discussion
may be found in the Clinical Guide chapters of this manual.

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AcuPulse Laser Safety

2.4. Laser Safety Laser safety eyewear is routinely required with most lasers. When using
Eyewear the laser system, the Laser Safety Officer should determine the need for
safety eyewear based on the Maximum Permissible Exposure (MPE),
Nominal Hazard Zone (NHZ), the Nominal Ocular Hazard Distance
(NOHD), and the optical density (OD) for the available laser emission and
the configuration of the treatment room (usually within the controlled
area). For additional information, refer to ANSI Z136.1-2000, ANSI
Z136.3-2005, or European Standard EN 60825.

The following formula was used to calculate the worst case NOHD for the
Lumenis AcuPulse laser system used with the articulated arm.

Where:
Z= the distance of the beam waist from the laser system;
a= the beam waist diameter (1/e2 of axial irradiance for Gaussian
beam);
θ= minimum full angle beam divergence (1/e2 of axial irradiance for
Gaussian beam);
e≈ 2.7182818285, the base of natural logarithms;
Φ= maximum energy of one laser pulse or maximum CW laser power;
Pf = the profile correction factor (1 for uniform profile or 2 for
Gaussian irradiance);
MPE = Maximum Permissible Exposure, in energy density units (energy
per unit area), or power density units (power per unit area);
NOHD = the Nominal Ocular Hazard Distance (measured from
laser aperture;
= the distance required to reduce the energy density or power
density to the MPE.

Z
1 4
NOHD = Z + Pf - a 2
MPE
Laser System

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Laser Safety AcuPulse

Using this approach we derive the following values:

θ= 0.00952 rad;
Ф (Maximum Average Power) = 40W;
MPE = 0.1 W/cm2 for CO2 laser;
Pf = 2 for Gaussian irradiance;
a= 0.257 cm;
Z= 165 cm;

which results in a worst case NOHD of: 337 meters.

All personnel within the operating area of the laser must wear eye
protection with protection level D LB4, I LB3 for 10600 nm according to
EN 207 and with a minimum optical density (OD) of 4.0 for 10600 nm
according to ANSI Z 136.3.
In addition to providing the required laser safety eyewear, take the
following steps to secure the treatment room:
1. To alert personnel before they enter the controlled area, place a
warning sign on the outside of the treatment room door when the laser
is in use.
2. Close the treatment room door during operation of the laser.
3. External door interlocks that automatically disable the laser when the
treatment room door is opened may be installed.

Note
A blocking barrier, screen, or curtain capable of blocking or filtering
the laser beam could be placed to create a controlled area inside a
large treatment room. The barrier should be made of material that
can withstand the power of the treatment beam for the maximum
exposure time, relative to the configuration of the controlled area
and the treatment parameters for the specific medical application.

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AcuPulse Laser Safety

2.4.1. Additional Ocular Warning

Protection
• Always verify that the delivery device is properly connected to
the laser. An improper connection may result in an inadvertent
secondary laser beam. Severe eye or tissue damage could
occur.

• Never substitute prescription eyewear for the appropriate laser

safety eyewear, as severe eye damage could occur.
Prescription eyewear can concentrate the laser light to the eye
and/or can be shattered by a high power density beam,
possibly causing severe eye damage.

• Use caution when performing procedures around the eyes.

Severe and irreversible eye damage and scarring may occur
from direct or indirect exposure to the treatment beam. The
predominant ocular structures at risk are dependent on the
laser wavelength in use. In general, visible and near-infrared
wavelengths are most damaging to the retina, while ultraviolet
or infrared wavelengths are most damaging to the cornea and
sclera. Severity of injury depends on how concentrated or
diffused the treatment beam is and the length of exposure. A
thorough understanding of the specific ocular risks and safety
precautions for each laser wavelength is necessary to ensure
the safety of the patient and operating personnel.

• Never look directly into any optical lens, scanner, handpiece,

probe, laser articulated arm or laser system aperture while the
laser is energized. Severe eye or skin damage could occur.
Turn off the laser before inspecting any delivery system or laser
components.

• Depending on the procedure, the physician must protect the

patient’s eyes with either laser safety eyewear or one of the
following items moistened with a nonflammable solution: thick
cloth, eye pads, or gauze 4 x 4’s.

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Laser Safety AcuPulse

2.5. Additional Safety Warning

Considerations
• Scan shape & size or spot size and laser energy are
independently controlled. If the user changes to a delivery
system with a smaller spot size during a procedure, the user
must remember that the energy or power density will increase.

• Incision/excision ideally should be performed with small laser

spot sizes and appropriate power/energy densities. At the
highest power densities, avoid prolonged exposure to limit
depth of incision.

• Plastic instruments such as speculums or eye shields can melt

when impacted by the laser beam, possibly resulting in
chemical burns or noxious gases. Therefore, use only stainless
steel surgical instruments designed specifically for laser use.

• Carbon dioxide light can be reflected off of smooth metallic

surfaces, even though they may be blackened.

Caution

• US federal law restricts this device to sale by or on the order of

a physician.

• Lumenis medical lasers and laser delivery systems are

intended solely for physicians trained in the use of these
instruments.

2.5.1. Skin Hazards The skin is the second most vulnerable organ of the body. The damage
from either direct or reflected laser light is thermal and shows as an
erythematous reaction (reddening). The skin may also become dry and
itch, or even char.

• Drapes – use wet packs or wet drapes and cotton pads thoroughly
moistened with sterile saline to protect the patient from adjacent tissue
burns.

• Gloves and Gowns – the clinician should wear gloves and gowns for
added protection from chronic skin exposure.

• Hair – wetting the hair during procedures on the face and scalp will not
guarantee it will not burn. Surgically drape hair to the maximum extent
possible.

• Accessory Tips – the tip of the accessory may become hot during
lasing and may cause tissue damage to either the clinician or patient on

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AcuPulse Laser Safety

contact. After lasing has stopped, allow the tip to cool before touching
it.

• Diffuse reflections – in some cases the patient may be burned by

diffuse reflections from instruments and other surfaces. When
procedures are performed in the clinic or office, neither doctor nor
should patient wear reflective jewelry, such as gold watchbands, rings,
or pendants.

2.5.2. Smoke Warning

Evacuation –
Laser Plume • Laser plume may contain viable tissue particulates.
Pollution Hazards • The laser plume obscures the operative field and is noxious to
those who come into contact with it. The plume presents a
possible biologic and pollution hazard and should be effectively
evacuated.

Operators are advised to consider the following:

• A commercial smoke evacuator designed for use with surgical lasers

may be used; these are usually most effective when the plume is
extensive. The vacuum tubing or probe used to evacuate the laser
plume should not be used to suction blood or fluids unless it is
specifically designed and set up to perform both functions
simultaneously.

• Instruments with built-in features to enhance evacuation of the laser

plume (such as speculums and laryngoscopes) should be used whenever
possible.

• Special in-line vacuum systems designed for evacuation of the laser

plume may be installed. Flow capabilities should be adequate to
effectively remove the laser plume.

• Repeated suctions of the laser plume into standard hospital wall suction
systems without the use of an in-line filter system may eventually clog
that system, requiring extensive repair. For minor procedures, wall
suction may be used; however, first install an in-line disposable filter.

• The operating surgeon should be wearing a micron-filtered mask during

the procedure.

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Laser Safety AcuPulse

2.5.3. Airway Use of the laser in the presence of oxygen increases potential fire hazard.
Precautions When performing a laser procedure, the surgeon and anesthesiologist
should carefully consider airway management. Oxygen concentrations
should be as low as clinically permissible during airway laser procedures.
Anesthetic gases should be least-supportive of combustion.

When choosing endotracheal tubes consider the complications that may

result from by-products of tube combustion. Use endotracheal tubes that
are least hazardous to the patient. Laser-resistant, cuffed, and flexible
stainless steel endotracheal tubes are commercially available. Red rubber
or silicone endotracheal tubes with FDA-approved, laser-resistant
wrapping can also be used.

The endotracheal tube cuff can be inflated with saline to protect it from
inadvertent penetration. The saline can be dyed with methylene blue so
that evidence of cuff-penetration by the laser will readily appear on
surrounding gauze sponges. The endotracheal tube can be further protected
by strategic placement of wet sponges to absorb accidental or stray laser
energy. Ensure that the sponges do not dry, as this increases potential fire
hazard.

2.5.4. Protecting Non- Non-target tissues may be protected in the following ways:
Target Tissues
• Saline soaked gauze sponges, moistened cotton-tipped applicators, or
titanium rods may be used as backstops for the laser beam.

• Saline may be used in the abdomen to absorb stray laser energy.

• Specialized instrumentation such as laparoscopes with laser beam

backstops and retractors designed to protect nontarget tissues may be
used.

• Patients' lips can be protected by moist gauze. When operating in the

oral cavity, care should be taken to protect teeth and bone by using wet
gauze or other nonflammable, heat-absorbing protective material.

• When anesthesia or pain medication is not used, the comfort and pain
tolerance of the patient must be assessed. Unexpected movement by the
patient could result in unintended laser exposure to nontarget tissue.

Caution

• To prevent unintended laser discharge, always turn off the

laser before connecting a delivery system.

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Warning

• Never discharge the laser without a target to absorb it and

without consideration given to what lies behind the target. Place
energy-absorbing material behind the target tissue when aiming
the laser at an oblique target.

• Metal instruments used behind the area of treatment, such as

tongue depressors or laser backstops, must be anodized or
ebonized matte-finished to avoid reflection.

• Unintended tissue damage can occur due to incorrect energy,

repetition rate, exposure duration, or power application. The
lowest energy, repetition rate, exposure duration, and power
settings that are effective for the intended application should be
used until familiar with the instrument's capabilities. Extreme
caution should be employed until you understand the biological
interaction between the laser energy and tissue.

• Except during actual treatment, the system must always be in

Standby mode. Maintaining the system in Standby mode
prevents accidental laser exposure if the footswitch is
inadvertently pressed.

• Only the person directing the laser beam towards the target
tissue should have access to the laser footswitch. Use caution
pressing the laser footswitch when it is in proximity to
footswitches for other equipment. Make sure the footswitch
pressed is the correct one to avoid unintended laser exposure.

• Never place hands or other objects in the path of the laser

beam. Severe burns could occur.

• Dirty optical components degrade laser energy transmission.

Cleaning the device optics may eliminate this problem;
however, this may also effectively increase the laser energy
delivered to the treatment site, causing an unintended tissue
effect and possible serious tissue damage. Therefore, it is
important that after cleaning the device optics, and prior to
surgical use, the surgeon test the system and device to verify
the lowest effective settings for the specific procedure. The
lowest effective treatment settings should be used until the
biological interaction and surgical effect are verified. Settings
can then be increased in appropriate increments until the
optimum treatment settings are obtained.

• Backstops exposed to continuous CO2 laser energy may

become excessively hot. Do not allow a hot backstop to touch
tissue or any flammable materials. Doing so may cause
possible injury or fire.

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2.6. Fire Hazards Operating room personnel should be aware of the following safety
considerations and potential fire hazards when using a CO2 laser:
• A CO2 laser beam can ignite most non-metallic materials.
• Use fire-retardant drapes and gowns.
• A UL or CE approved or equivalent fire extinguisher and water should
be readily available.

Warning

• Do not use this device in the presence of flammables or

explosives, such as volatile anesthetics, alcohol, volatile
surgical preparation solutions, and similar substances. An
explosion or fire could occur.

• The area around the target site can be protected with wet
towels or gauze sponges. If allowed to dry, these protective
towels and sponges can increase the potential fire hazard.

• When procedures are performed in the perianal area, the

flammability of methane gas must be considered. Moistened
sponges should be inserted into the rectum.

• Never use oxygen as a purge gas. When used with lasers,

combustible gases, such as oxygen, increase the potential fire
hazard, and may cause patient injury.

• Laser treatment of adipose tissue may cause cellular fat to

liquefy and accumulate into lipid pools. Pooled lipids are
flammable and can be ignited by laser radiation, resulting in fire
and potential patient injury.

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2.7. Electrical Hazards Because the AcuPulse contains high-voltage components, there is a danger
of severe shock if its covers are taken off by other than trained personnel.
In addition, the system must be properly grounded during operation.
Always use proper cables and do not attempt to use three-prong adapter
plugs to defeat the grounding system. The use of extension cables is not
recommended.

To guarantee both operator and patient safety, operator service is limited to

the items described in the Maintenance chapter of this manual. Other
service must be performed only by Lumenis trained personnel.

Warning

• Never open the laser console protective covers. Opening the

covers will expose personnel to high voltage components, the
laser resonator and possible laser radiation. Only Lumenis-
certified service technicians are qualified to service the system.

• To avoid electrical shock, the area around the laser and

footswitch should be kept dry. Do not operate the laser if any of
the cables are faulty or frayed. The laser should undergo
routine inspection and maintenance per Lumenis'
recommendations and institutional standards.

2.7.1. Grounding the Proper grounding is essential for safe operation. The system is grounded
System through the grounding conductor in the power cable. To ensure grounding
reliability, always plug the power cable into a properly wired hospital
grade power receptacle. For potential equalization, use the equipotential
terminal on the system's service panel (see Chapter 3).

Warning
Use the system only when it is properly grounded via the ground
wire lead in the power cable supplied with the AcuPulse system.

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2.8. Operating Safety Cautions & Warnings

2.8.1. Cautions Fire – keep a bottle of sterile saline and a fire extinguisher in the same
room where a laser procedure is being performed.

Training – do not use the AcuPulse in clinical, office or surgical

procedures unless you have been trained:
• In general laser safety, including operator and patient protection.
• By a qualified mentor in hands-on situations.
• On the AcuPulse system.

Before Performing Procedures – read this manual before performing any

patient procedures. The information in this manual should be used in
conjunction with, not as a substitute for, formal training.

Power Settings – Lumenis suggests that you begin new or unfamiliar

procedures at the lowest recommended power settings and gradually
increase the setting until you see the desired effect.

Accessory Cleaning –

• To avoid losing efficiency of any non-electronic accessory, always

rinse thoroughly after cleaning and dry thoroughly before use.
• Disassemble and clean the accessories over a white cloth so that
small dropped parts are easier to find.

Handpiece Sterilization –

• After sterilization, handpieces with internal mirrors must be

completely dry before use.
• If a liquid or steam sterilant is used, make sure that all parts in the
laser beam path are completely dry before use.

Smoke Evacuation – always evacuate smoke. If the smoke evacuator on

the system you are using shuts off during the procedure, use another
smoke evacuator.

Console Cleaning – when cleaning the console, use a dampened cloth.

Avoid saturating the exterior panel areas and electrical input area.

Static-Sensitive Components – electronic components in laser systems

may be sensitive to damage. Use proper grounding techniques.

Warranty Void – internal maintenance by unqualified service technicians

may cause system damage. This damage is not covered under warranty.

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2.8.2. Warnings CO2 Laser – 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 devices.

To Avoid Injury or Fire – observe all warning and other labels on the
equipment. Failure to do so could result in injury or fire.

Inadvertent Lasing – when not actively lasing, set the system to Standby
mode.

Backstop Lasing – avoid lasing on the backstop.

Accessory Sterilization – sterilize accessories before each use.

Sterility – wear sterile gloves and use aseptic technique when handling the
accessories in order to maintain their sterility.

Infection Control – with all accessories, always use good infection control
practices, including barrier products and sterile components when
appropriate.

Risk of Embolism –

• During intrauterine laser surgery, do not use air for purging the
laser accessory or for insufflation. This may cause a life-
threatening air embolism.
• Pressurized purge air exits accessory aperture tip during lasing. To
reduce the risk of an air embolism, do not bring the aperture into
contact with a blood vessel or vascular tissue.

Laser Emission – in Ready mode laser light will be emitted through the
laser aperture when the footswitch is pressed.

Handling of Compressed Gas Tanks – for safe gas tank handling:

• Gas tank must be secured in position prior to use.

• Review proper procedures for handling compressed gasses before
assembling yoke or CGA valve to tank. Check with your
Biomedical Engineer if you are unfamiliar with this procedure.

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Laser Safety AcuPulse

2.9. System Safety The AcuPulse is equipped with various built-in safety features to provide
Features maximum protection for both clinician and patient. Before using the
system for the first time, become familiar with these features and how they
operate.

2.9.1. Password Entry to the system's surgical operating program is protected by a

Protection password assigned to each user of the system (see Chapter 5). If the
password is not keyed in, the operating system is not accessible and laser
beam emission will not be available.

2.9.2. Self Testing at When the AcuPulse is turned on, the system computer automatically
Start Up executes system self-testing. Self-testing checks the following:
• Ability of the system to generate lasing power
• Functionality of the computer systems
• Safety monitoring circuits

If the self-test is successfully completed, the system enters Standby mode.

The test circuits continuously monitor the operation of the system during
treatment.

2.9.3. Safety Shutter The automatic safety shutter blocks the laser beam to prevent accidental
lasing.

The automatic shutter is opened when the footswitch is pressed. When the
footswitch is released, the shutter closes. Lasing typically stops within
1/10th of a second.

2.9.4. Door Interlock The door interlock connector plug must be inserted into the proper
Connector receptacle on the system's service panel in order for the laser to operate. It
can be wired to an external switch to disable the laser if the treatment room
doors are opened during treatment.

2.9.5. Safety Interlocks

and Failsafes

2.9.5.1. Dual-Footswitch The footswitch incorporates a dual-microswitch safety mechanism, which

Microswitch requires the pedal to be firmly pressed – operating both microswitches – in
order to generate laser beam emission. If the footswitch is pressed too
lightly, it will not operate.

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AcuPulse Laser Safety

2.9.5.2. Laser Stop Button This red knob is designed for emergency shutdown. When pressed it
immediately disables the laser and switches the system to Standby mode.

To release the emergency shut-off button, turn it clockwise in the direction

of the arrows. Once released, the system must be turned off and back on to
restart.

2.9.5.3. Shutter Position The AcuPulse incorporates optoelectronic detectors which monitor the
Failsafe opening and closing of the automatic shutter. This monitoring helps to
ensure that shutter failure is recognized. If the shutter does not close within
½ second after releasing the footswitch, or open when pressing the
footswitch, lasing is disabled.

2.9.5.4. Power The AcuPulse compares lasing power as read by the internal power meter
Measurement to an internal table of anticipated electrical input power. If there is a
Failsafe significant discrepancy, an appropriate error message is displayed.

2.9.6. Safety Timer The safety timer resets the system from Ready to Standby mode if the
system is left idle in Ready mode for more than a user-defined time limit,
to prevent unintentional activation of the laser with the footswitch.

2.9.7. Continuous The system's computer continually monitors internal system status. The
Internal System following are among the items monitored:
Monitoring

2.9.7.1. System Faults If a fault is detected an appropriate error message is displayed on the LCD
monitor. If the error is non-recoverable lasing is disabled until the fault is
corrected. If the error is recoverable, follow instructions on the screen.
A complete discussion of system faults may be found in the Trouble-
shooting chapter of this manual.

2.9.7.2. Internal Power To prevent accidental delivery of excessive energy to tissue, laser energy
Monitoring is monitored continuously. An appropriate error message is displayed on
the LCD monitor if a ±20% deviation in the laser output is detected, the
system returns to Standby mode and you may try power convergence to
the same level or a different one.

2.9.7.3. Temperature If the system begins to overheat, an appropriate error message will be
displayed on the LCD monitor (refer to the Troubleshooting chapter of
this manual).

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Laser Safety AcuPulse

2.9.8. Laser Beam The system features two laser emission indicators: a yellow LED located
Emission on the top of the control console and a speaker.
Indicators
The yellow LED has three modes of operation:
• Off - When the system is turned on, and in Standby mode.
• Flashing - In Ready mode, alerting the user that laser emission
will start upon footswitch activation.
• Continuous - During laser emission (footswitch pressed or during
power convergence).

The speaker sounds during laser emission.

2.10. Compliance with Refer to the Lumenis website (www.Lumenis.com) to view a complete list
International of international regulatory standards that the AcuPulse system is designed
Standards to comply with.
In compliance with these standards, the system is equipped with:
• Laser emission indicators
• Beam shutter
• Power display
• Emergency shut-off button
• Door interlock connector
• Proper labeling

In accordance with the regulations, a recommended routine inspection and

maintenance schedule is provided in the Maintenance chapter of this
manual.

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AcuPulse Laser Safety

2.11. Warning, Figure 2-2 displays the labels affixed to the system:
Certification and 1. Identification and Certification – The label is located on the system's
Identification rear panel and contains the following information:
Labels
• Manufacturer's and/or distributor's details.
• Assures that the system complies with U.S. Federal Performance
Standards.
• System's model name and part number.
• Serial number and date of manufacture.
• The system's electrical requirements.
• Degree and type of protection against electric shock.
• – Follow instructions for use.
• CE marking.
• CSA – compliance symbol.
• WEEE symbol – directs that the electrical/electronic product be
disposed of in an environmentally safe way as the directive sets
collection, recycling and recovery targets for all types of electrical
goods.
• Location of US patents on file for the AcuPulse system.
2. Laser Emission Danger – warns against possible exposure to laser
beam radiation and specifies the type and classification of laser beams
present. The label is located on the system's rear panel.
3. Non-Interlocked Warning Label – warns against and about:
• Risk of explosion if used in the presence of flammable anesthetics.
• Possible electrical shock when covers are removed.
• Proper electrical grounding of the system.
4. Laser Aperture – indicates laser beam exit location, located at the
articulated arm's endjoint.
5. Articulated Arm Release – advisory to release the articulated arm
from its storage without damage.
6. Federal Law Restriction – USA federal law restricts this device to
sale by or on the order of a physician.
7. EPUP – Environmental Protection Use Period: indicates the number
of years before any substance is likely to leak out into the
environment.

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Laser Safety AcuPulse

Figure 2-2: System Labels

2-22 UM-1091300, Rev. F

3.

Chapter 3
System Installation

3.1. Introduction When the AcuPulse system is purchased, complete on-site installation,
including initial system testing and calibration, is included.
System transportation and installation is carried out by Lumenis
authorized personnel, who do the following:
• Unpack the system and position it in its pre-selected location.
• Verify the integrity of the system and its components.
• Plug the system into a designated electrical outlet.
• Test the system for proper calibration and functional operation of all
components and software.
• Coordinate the performance of an on-site safety inspection, if required.
Note
In Canada this instrument must be installed and operated according
to CAN/CSA-Z386-08: Laser Safety in Health Care Facilities.

3.2. Unpacking the The AcuPulse system is shipped in a shockproof container. Contents may
System vary according to the purchase agreement with Lumenis, but the parts and
accessories generally shipped in the container are:
• AcuPulse system console
• Safety eyewear
• Footswitch
• System accessories 1
• Bacteriological filter
• Door interlock connector plug (installed)
• Laser danger sign(s)
• Operator’s manual
• Instructional material

1
According to purchase agreement

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System Installation AcuPulse

To unpack the AcuPulse, carefully remove all components from the

shipping container. Set the console down on its base. Save all packaging
materials in case repacking and shipping becomes necessary at a later date.

3.3. Facility Before unpacking the system, ensure that the site meets the requirements
Requirements described in the following sections.

3.3.1. Space and Space should be allocated with adequate ventilation and free air flow. The
Positioning working area for the system should be prepared according to the
Requirements dimensions shown in Figure 3-1. In order to guarantee proper ventilation,
and easy accessibility to the power circuit breaker, always keep the sides
of the system at least 0.5 m (20") from the wall or from other obstructions
to air flow. After positioning the system, lock the wheels’ brakes by
pressing the pedals on top the four wheels.

Figure 3-1: Physical Dimensions

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AcuPulse System Installation

3.3.2. Electrical The system is equipped with a universal power supply module.
Requirements Accordingly, the system will require a separate line supply of:
• 100-240 VAC, 9A, 50/60 Hz, single phase

Input power lines should be free of transients, voltage and current spikes,
sags and surges. Consequently, the system power line should not be shared
with other heavy variable loads such as elevators, air conditioning systems,
large motors, etc.

It is strongly recommended that the system be connected to a separate

power line with separate circuit breakers. Lumenis cannot guarantee
adequate performance unless the system is connected to a dedicated
circuit.

3.3.3. Environmental Air Quality:

Requirements The system should operate in a non-corrosive atmosphere. Corrosive
materials such as acids can damage electrical wiring, electronic
components and the surfaces of optical components.

Air-borne dust particles should be kept to a minimum. Dust particles

absorb light and heat up. Hot particles located on the optical lenses can
damage them. Metallic dust is destructive to electrical equipment.

Temperature:
To ensure that the system performs optimally, it is recommended to
maintain ambient room temperature between 5°C and 30°C (41°F - 86°F)
and relative humidity of 5-85% non-condensing. When the system is used
intensively it will emit heat. Therefore, it is recommended that the
treatment room be air-conditioned.

3.4. Installation and The system has passed full quality assurance testing before shipment and
Setup should be operational upon delivery.

Note
Any damage to the packaging or to the system found prior to
opening the packaging, or during unpacking and installation of the
system, should be immediately reported to your Lumenis distributor
and to the insurance carrier.

On-site system installation and initial setup should be carried out only by
Lumenis-authorized personnel.

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System Installation AcuPulse

The assembled AcuPulse laser system is shown in Figure 3-2.

Figure 3-2: Assembled AcuPulse Laser System

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AcuPulse System Installation

3.4.1. Articulated Arm Refer to Figure 3-3:

Setup
1. Release the articulated arm endjoint from its clip in the articulated arm
compartment (A).

2. Release the longer arm section from its clip only by pulling the tab
attached to the arm (B); release the arm from its compartment.

Caution
Pulling the endjoint or the shorter arm section to release the arm
from its compartment may result in misalignment of the optical
system.

3. Raise the longer arm section until the arm locking pin on the main
bearing is engaged (you will hear and feel a 'click').

4. Rotate the articulated arm 180° around the main bearing axis.

5. Disengage the tab and clip to release the short section of the arm from
the long section.

Figure 3-3: Release the Articulated Arm

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System Installation AcuPulse

3.4.2. Bacteriological A dedicated unidirectional bacteriological filter is supplied with the

Filter Installation AcuPulse system to provide clean compressed air at the surgical accessory.

The filter is equipped with a short flexible tube on its outlet for connection
to the nipple on the laser surgical accessory in use. The inlet (free end) of
the filter should be connected to the delivery nipple of the compressed air
supply on the system's control panel. Then the filter should be clipped onto
the last arm section, as close as possible to the endjoint. The compressed
air flow through the bacteriological filter should be inspected prior to each
use and replaced when insufficient flow is detected.

3.4.3. Service Panel The service panel is located on the lower section of the system's rear panel
Connections and incorporates the following (see Figure 3-4):
1. Power cable connection port.
2. Power circuit breaker.
3. Footswitch connection port.
4. External equipotential connection port.
5. Smoke evacuator connection port.
6. Door interlock connection port.
7. USB connection ports.
8. LAN connection port.
9. Remote control connection port (future option).
10. VGA monitor port.
Refer to Chapter 4 for a complete discussion of these elements.

Figure 3-4: Service Panel

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AcuPulse System Installation

3.5. Initial System Prior to clinical use, test out the AcuPulse system to verify that the system,
Testing including its built-in safety features, is operational.

Read the entire operating manual before turning on the system. Of

particular importance is Chapter 2 – Laser Safety.

Before beginning system test, make sure that the laser operating area is
safe and secure. As when performing any laser procedure, flammable
materials should be moistened or beyond contact of the laser beam. All
personnel should wear protective goggles or glasses.

The required test includes the following procedures, which should be

performed in the order indicated:
1. System Startup – see Section 3.5.3
2. Door Interlock Check – see Section 3.5.4
3. Footswitch Interlock Check – see Section 3.5.5

If at any point during the test the system does not perform as described,
discontinue use and contact Lumenis Service.

3.5.1. System Controls Before beginning the initial system test, familiarize yourself with the
system controls described below. Use of the controls is described fully in
the Operating Instructions chapter of this manual.

3.5.2. Main Control The main control panel is located at the top of the console and incorporates
Panel system controls and the touch-screen LCD panel.

Refer to Figure 3-5: For initial system testing it is important to know the
locations of the On/Off switch, the Emergency Stop button and the Laser
Emission indicator.

3.5.3. System Start Up 1. Turn the system's power circuit breaker – located on the service panel
(see Figure 3-4) – to the On position.

2. Make sure that the emergency stop button is not engaged (pressed
down). If it is, turn it clockwise until it releases and pops up.

3. Press the On/Off switch; the system will turn on, the software will
initialize and the LCD panel will display a splash screen.

4. The system will perform a series of internal power-up routines. When

these have completed satisfactorily, the Login screen will appear on
the LCD (see Chapter 5).

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System Installation AcuPulse

5. If the system does not perform as described, discontinue use and

contact Lumenis Service. If the system performs as described,
complete the login and continue on to the footswitch check (see
Section 3.5.5).

Figure 3-5: Control Panel

3.5.4. Door Interlock Laser beam emission is disabled when the door interlock plug is not
Check connected or is improperly connected to the service panel, even if it is not
wired to an actual door interlock. To check this:
1. Set the system to Ready mode.

2. Unplug the door interlock plug; the system should display the
following error message: Remote Interlock error. Please verify
treatment room door is closed.

3. If the system does not display the error message and remains in Ready
mode, discontinue use and contact Lumenis Service.

3.5.5. Footswitch Laser beam emission is disabled when the footswitch is not connected or is
Connection Check improperly connected. To check this:

1. Set the system to Ready mode.

2. Unplug the footswitch; the system should display the following error
message: Footswitch is not connected. Please connect.

3. If the system does not display the error message and remains in Ready
mode, discontinue use and contact Lumenis Service.

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AcuPulse System Installation

3.5.6. Laser Stop Button The Laser Stop button is designed to disable laser emission when pressed.
Check To check this button:
1. While the system is on and the main Treatment screen is displayed,
press down on the laser stop button; the system should display the
following error message: Laser stop button engaged. Please
disengage to proceed.
2. To resume operation, turn the button clockwise until it pops up; the
system will return to Standby mode.
3. Touch the Ready key to enable lasing.

3.6. Moving, Transporting and

Storage

3.6.1. Moving the Most users of the AcuPulse laser system have more than one operating
System within the location. The system can easily be moved between them by rolling the
Facility console on the base-mounted wheels using the top-mounted maneuvering
handle. The only disassembly required is disconnection of the footswitch
and power cable to ease maneuvering.
Rather than disconnecting them for each move, it may be easier to install a
power cable and footswitch in each location, leaving them in place.

3.6.2. Transporting the Prepare the system for transport as follows:

System 1. Unplug the system from the wall outlet.
2. Disconnect any accessory connected to the articulated arm.
3. Coil the power cable around the cable hangers on the rear panel.
4. Disconnect the footswitch from the service panel.
5. Fold and store the articulated arm in its storage compartment in the
system's rear panel.
6. Consult your Lumenis representative for shipping advice if desired.

Caution
Do not ship the system without the factory packaging materials.
Doing so may result in damage to the components during shipping
and void the warranty. Contact Lumenis if packaging materials or
repacking instructions are required.

Warning
The AcuPulse console weighs approximately 50 Kg (110 Lbs). Use
proper lifting techniques. Do not hurt yourself!

UM-1091300, Rev. F 3-9

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System Installation AcuPulse

3-10 UM-1091300, Rev. F

4.

Chapter 4
System Description

4.1. General Laser LASER is the acronym for Light Amplification by Stimulated Emission of
Theory Radiation. The laser is a device consisting of an active medium and a
pumping source, enclosed in a pump cavity. The pumping source "pumps"
the active medium from its ground energy state to excited states. If
"population inversion" between two excited states takes place (where the
higher energy state is more populated) stimulated emission of radiation
(photons) can occur. This emission is resonated (reflected back and forth)
within the optical resonator and is amplified. A portion of this amplified
electromagnetic radiation is then emitted as a laser beam.

The main properties of the beam are:

• Monochromaticity – the radiation is within an extremely narrow
wavelength range on the spectrum
• High degree of collimation – unidirectional beam with very small
divergence
• Coherence – all photons are in phase, both in space and time

The high degree of collimation and coherence enable the focusing of the
beam to small spot sizes.

The active (lasing) medium of a laser can be either gas, liquid or solid.
Most gas lasers consist of atoms, molecules, or mixtures of both. Solid-
state lasers consist of atoms or ions "doped" in some solid matrix. Liquid
lasers consist of higher molecular weight molecules dissolved in liquids.

Under specific pumping conditions, all these materials can undergo the
unnatural phenomenon of "population inversion" that results in stimulated
emission of radiation at a wavelength characteristic of the active medium.

4.2. CO2 Laser Theory This system incorporates a DC-excited CO2 laser tube. The gas used is
enclosed within a glass laser tube equipped with electrodes. The laser tube
is positioned between the two mirrors of the optical cavity. The rear mirror
is totally reflective, whereas the front mirror is partially reflective and
transmits the CO2 laser beam into the delivery system.

The direct current power supply (pumping source) provides voltage to the
electrodes which produce an electrical discharge perpendicular to the tube.
The discharged electrons collide with the CO2 molecules in the gas mixture,
and excite them to a vibrationally excited level (an asymmetric stretching
mode).

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System Description AcuPulse

The stimulated emission takes place between this level and a lower
vibrationally excited level (a symmetric stretching mode), resulting in laser
emission in the far infrared range at a wavelength of 10.6 microns.

The CO2 laser wavelength falls in the mid-infrared region of the

electromagnetic spectrum. This wavelength is invisible to the human eye.

CO2 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.

4.3. AcuPulse Laser The AcuPulse is an advanced computer-controlled, user friendly CO2 laser
System system based on a sealed-off CO2 laser tube providing up to 30 or
40 Watts (model dependent) on tissue. The system incorporates the CO2
laser tube within the main cabinet, an articulated arm beam delivery
system and attachable laser accessories. The system is activated for laser
emission by a footswitch.

4.4. System Description The AcuPulse laser system is composed of the following units:
• Control Panel – situated on top of the system's console, incorporating:
 System controls
 A liquid crystal display (LCD) with touch-screen technology.
• Electronic and Software Systems – control, display, and monitor the
system; the GUI computer:
 Translates GUI commands to signals and controls.
 Controls the interface module's operation.
 Incorporates the operating system and runs the self-test routine.
 Monitors and regulates laser output power.
 Automatically tests the system, monitors its performance, and
indicates specific malfunctions.
 Automatically shuts off the laser during unsafe operating conditions.
 Acts on commands from the control panel and updates the display.

• Interface Module – that serves as in interface between the system's

main computer and modules.
• Low Voltage Power Supply – provides modulated power low DC
voltage, and DC voltage to the HVPS.
• High Voltage Power Supply – converts low DC voltage to high DC
voltage for laser generation.

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AcuPulse System Description

• DC Excited CO2 Laser Tube – creates the laser beam. The laser is a
sealed-off, DC excited, free-space CO2 laser. The system generates a
narrow, concentrated beam of invisible infrared light of a 10.6 micron
wavelength.
• Optical Bench Assembly – the optical bench transmits the laser
energy from the output of the laser tube to the treatment site. Inside the
console the beam is directed by folding mirrors past an automatic
shutter. The beam delivery articulated arm is mounted on top of the
console.
• Power Meter – the system's internal power meter samples the laser
power during the power convergence, after the user selects the desired
power and enters Ready mode.
• Purge Air Pump – the system console contains a built-in air pump
which provides purge air flow, through a bacteriological filter, to blow
away smoke. The air flow is automatic during lasing, and it continues
for a user-defined number of seconds after lasing stops.

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System Description AcuPulse

Figure 4-1 presents a description of the AcuPulse laser system

Figure 4-1: AcuPulse System Description

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AcuPulse System Description

4.4.1. Control Panel The AcuPulse control panel, located on top of the system console,
incorporates the following elements (refer to the numbered items in
Figure 4-2):

1. On/Off Switch – a push-button switch that initiates the system's

functions. A green LED indicator built into the button indicates that
the system is on.

2. Laser Stop Button – a two-position, normally released, push-type

button for emergency shutdown of laser emission. The button actuator
is a large, red mushroom-shaped knob that is operated by pressing
down. To release the switch to its normal position, rotate the knob
(direction is marked on the knob's face).

Caution
The laser stop button should be activated only in case of an
emergency.

Figure 4-2: Control Panel

3. Laser Emission Indicator – the yellow LED has three modes of

operation:
 Off – when the system is turned on, and in Standby mode
 Flashing – in Ready mode, alerting the user that laser
emission will start upon footswitch activation
 Continuous – during laser emission (footswitch pressed or
during power convergence)

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System Description AcuPulse

4. Flashscanner Connection Port – this is the connection point for the

communications cable of the SurgiTouch flashscanner or AcuScan120
microscanner.

5. Purge Air Tube Connection Barb – this is the connection point for
the purge air tube.

6. LCD Touch-Screen Panel – communication with the system is

performed by means of the touch-screen panel. All commands are
inserted into the system by "pressing" the appropriate "buttons", or
keys, on the LCD. Figure 4-3 presents a sample control screen; all
aspects of the operating system will be discussed in the Operating
Instructions chapter of this manual.

Figure 4-3: AcuPulse Treatment Screen (sample)

4.4.2. Optical Bench The optical bench assembly is comprised of the sealed-off laser tube and
Assembly its optical resonator, the CO2 laser shutter assembly, the power meter, the
aiming beam assembly and the CO2 and aiming beam combiner.

The aiming beam is a low-powered diode laser with an adjustable intensity

control. It can also be configured to illuminate constantly or blinking.

The beam combiner combines the CO2 laser beam and the aiming beam
coaxially, and guides them into the articulated arm beam delivery system.

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AcuPulse System Description

4.4.3. Cooling System The CO2 laser tube and the laser power meter are cooled by an internal
closed-loop liquid-to-air cooling system. The coolant used is Fluorinert
FC-770, an inert liquid that does not conduct electricity.

The coolant is circulated in the system by means of an electric pump,

absorbing heat from the CO2 laser tube and from the power meter. The
heat is expelled through a finned tube heat exchanger.

In addition to the coolant circulation system, a forced-air fan circulates air

through the system's console.

4.4.4. Service Panel The service panel is located on the bottom of the system's rear panel. The
panel incorporates controls and connection ports for the following (see
Figure 4-4):

Figure 4-4: Service Panel

4.4.4.1. Potential For potential equalization use the equipotential terminal on the system's
Equalization service panel (lower-left terminal in Figure 4-4).

Note
Using the equipotential terminal is recommended whenever it is
required to make the system equipotential with other systems
operating in the same environment.

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System Description AcuPulse

4.4.4.2. Footswitch To connect the footswitch, place it on the floor and plug its power cable
Connection into the footswitch connection located in the panel. Screw the cable's
threaded cap onto the connection terminal securely. A polarizer on the
socket prevents incorrect connection of the cable (see item # 3 in
Figure 4-4).

4.4.4.3. Door Interlock The door interlock connection is a safety feature that disables the laser if
Connection the treatment room doors are opened or the interlock plug is removed
while the laser is in Ready mode (see item # 6 in Figure 4-4).

Use of a door interlock connection is optional; however, you must insert

the interlock plug into the service panel receptacle whether or not you are
using a door interlock connection. The laser remains inoperative until the
plug is inserted into the receptacle.

When a door interlock connection is in use, the laser is automatically

disabled and returns to Standby mode if the treatment door is opened or
the interlock plug is removed, and an error message displays on the control
panel screen. To resume treatment, close the treatment room door or
reinsert the interlock plug, and press Ready to resume normal treatment.

4.4.4.4. Smoke Evacuator A portable smoke evacuation system may be connected to the system at
Connection this port (see item # 5 in Figure 4-4).

4.4.4.5. Power Circuit The power circuit breaker should be turned off when the system is left
Breaker unused for extended periods of time (see item # 2 in Figure 4-4).

4.4.4.6. Power Cable Connect the power cable to this port (see item # 1 in Figure 4-4).
Connection
Use only:
• The power cable and plug specified for your system
• A power cable and plug that are in good condition
• A hospital grade plug and a correctly matched power receptacle

4.4.4.7. USB Connections The USB connection ports are normally utilized by Lumenis-authorized
service engineers for servicing the system and for uploading periodical
software upgrades (see item # 7 in Figure 4-4).

4.4.4.8. VGA Monitor An external VGA monitor may be connected to the system (see item # 10
Connection in Figure 4-4).

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AcuPulse System Description

4.5. Understanding The AcuPulse delivers three basic modes of laser energy: CW, Pulser and
Laser Delivery SuperPulse:

• CW Mode is optimal for incision or ablation where hemostasis is

desirable. CW is a continuous delivery of lasing energy with peak
power as set. CW mode delivers a steady beam of laser energy useful
for cutting. Because the pulses of energy are continuous, just enough
energy is transferred to surrounding tissue to provide hemostasis, while
at the same time providing a clean incision with optimal penetration.

• Pulser Mode high-frequency delivers pulses in a constant preset pulse

frequency. The average power requested and delivered to tissue is
controlled by the microprocessor by varying the On time.

• SuperPulse Mode is optimal for incision or ablation where char-free

performance is desirable. This includes many dermal applications.
SuperPulse is a continuous series of short duration, high peak power
pulses whose average power is the set power. Because of its very high
peak power, SuperPulse laser energy brings the water in the cells to the
boiling point so rapidly that the target tissue vaporizes and only a
negligible amount of heat is transferred (by conduction) to adjacent
tissue.
The time between each SuperPulse of high energy is long enough that
the surrounding tissue has time to cool before being hit with the next
SuperPulse. Because of this, SuperPulse helps reduce charring and
minimizes surrounding tissue damage.
Tissue incision capability is generally enhanced with higher peak
power of the laser beam. Thermal damage to surrounding tissue is
usually reduced with shorter laser activation durations, whereby the
adjacent healthy tissue has more time to cool between pulses.

The three laser power modes can also be characterized as:

• CW – higher thermal energy is transferred to surrounding tissue.
• Pulser – medium thermal energy is transferred to surrounding tissue.
• SuperPulse – lower thermal energy is transferred to surrounding
tissue.

• Refer to Figure 4-5 through Figure 4-7 for CW, Pulser and SuperPulse
power delivery comparisons.

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System Description AcuPulse

4.5.1. Exposure Types Both CW and SuperPulse can be set to deliver any of three different
exposure types:

• In Continuous exposure, lasing lasts as long as the footswitch is

pressed.

• In Single exposure, one timed exposure is delivered for each press

of the footswitch.

• In Repeat exposure, the laser beam cycles between On and Off

while the footswitch is pressed.

POWER
[W] Continuous
Ppeak = Pav

TIME
[Sec]
POWER Single Pulse
[W]

Ppeak = Pav

TIME
ON Time [Sec]
POWER
[W] Repeat Pulse
Ppeak

Pav

TIME
ON Time OFF Time [Sec]
FOOTSWITCH DEPRESSED

Nested (Depth)= 3 – Only In SurgiTouch Mode

POWER
[W]
No. Of Exposures = 4 – SurgiTouch Treatment and Manual Treatment
Ppeak
Scan Scan Scan Scan Scan Scan Scan Scan Scan Scan Scan Scan
Pav No.1 No.2 No.3 No.1 No.2 No.3 No.1 No.2 No.3 No.1 No.2 No.3

TIME
ON Time OFF Time [Sec]
FOOTSWITCH PRESSED

Figure 4-5: CW Exposure Types

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AcuPulse System Description

POWER
[W] Continuous
Ppeak

Pav

TIME
[Sec]

POWER Single Pulse

[W]

Ppeak

Pav

TIME
[Sec]
ON Time
POWER
[W] Repeat Pulse
Ppeak

Pav

TIME
[Sec]
ON Time OFF Time

FOOTSWITCH PRESSED

Figure 4-6: Pulser Exposure Types

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System Description AcuPulse

POWER
[W] Continuous
Ppeak

Pav
TIME
[Sec]
POWER Single Pulse
[W]
Ppeak

Pav
TIME
ON Time [Sec]
POWER
[W] Repeat Pulse
Ppeak

Pav
TIME
ON Time OFF Time [Sec]
FOOTSWITCH DEPRESSED

Nested (Depth)= 3 – Only In SurgiTouch Mode

[W]
No. of Exposures = 4 – SurgiTouch Treatment and Manual Treatment
Ppeak
Scan Scan Scan Scan Scan Scan Scan Scan Scan Scan Scan Scan
No.1 No.2 No.3 No.1 No.2 No.3 No.1 No.2 No.3 No.1 No.2 No.3
Pav
TIME
[Sec]
ON Time OFF Time
FOOTSWITCH PRESSED

Figure 4-7: SuperPulse Exposure Types

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AcuPulse System Description

4.6. System
Specifications
4.6.1. Outputs Treatment Laser
• Type: CO2 laser tube, sealed-off, DC-excited
• Wavelength: 10.6 microns (invisible infrared)
• Mode structure: TEM00 (Gaussian)

Aiming Laser
• Type: Diode
• Wavelength: 635 nm
• Intensity: 6 settings – off to 5mW max.
• Operational modes: Continuous or blinking

Laser Operating Modes

• Continuous Wave (CW)
• Pulser
• SuperPulse (SP)

Tissue Exposure Modes

• Continuous
• Single Pulse
• Repeat Pulse

Continuous Wave Power

• 30 Watt model: 1.0 – 30.0 Watts
• 40 Watt model: 1.0 – 40.0 Watts

Pulser Average Power

• 30 Watt model: 1.0 – 25.0 Watts
• 40 Watt model: 1.0 – 35.0 Watts

SuperPulse Average Power

• 30 Watt model: 0.5 – 10.0 Watts
• 40 Watt model: 0.5 – 15.0 Watts

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System Description AcuPulse

ON and OFF Time Intervals – CW Exposure Type *

Tissue Exposure Power ON-Time OFF-Time Repeated
Mode [Watts] [Sec] [Sec] [Counts]
Continuous 1.0 – 4.5 *
Continuous 5.0 – 40.0
Single 1.0 – 4.5 * 0.05 – 1.00
Single 5.0 – 40.0 0.01 – 1.00
Repeat 1.0 – 4.5 * 0.05 – 1.00 0.01 – 1.00 2 – 10 **
Repeat 5.0 – 40.0 0.01 – 1.00 0.01 – 1.00 2 – 10 **
(*) Available only in Manual, No Scan and Blepharoplasty modes
(**) As long as the footswitch is pressed

ON and OFF Time Intervals – Pulser Exposure Type *

Tissue Exposure Power ON-Time OFF-Time Repeated
Mode [Watts] [Sec] [Sec] [Counts]
Continuous 1.0 – 35.0
Single 1.0 – 35.0 0.05 – 1.00
Repeat 1.0 – 35.0 0.05 – 1.00 0.01 – 1.00 2 – 10 **
(*) Available only in Manual, No Scan and Blepharoplasty modes
(**) As long as the footswitch is pressed

ON and OFF Time Intervals – SuperPulse Exposure Type *

Tissue Exposure Power ON-Time OFF-Time Repeated
Mode [Watts] [Sec] [Sec] [Counts]
Continuous 0.5 – 15.0
Single 0.5 – 15.0 0.05 – 1.00
Repeat 0.5 – 15.0 0.05 – 1.00 0.01 – 1.00 2 – 10 **
(*) Available only in Manual, No Scan and Blepharoplasty modes
(**) As long as the footswitch is pressed

Spot Size
• From 0.1mm, focused at 50mm working distance, to 6.7mm, fully
defocused at 400mm working distance.
• AcuScan120 Microscanner: fixed at 120 microns

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AcuPulse System Description

Delivery System
• Lightweight, carbon fiber, 7-joint, spring-balanced articulated arm
• Working radius at full arm extension: 120 cm (47")
• Horizontal rotation of articulated arm: 360°

4.6.2. Operation and Control

Control • Microprocessor based, touch screen, high resolution, multicolor GUI
• Storing and recall capability

System Turn-on
• Power circuit breaker on service panel
• On/Off switch on control panel
• Proprietary password access for each user

System Turn-off
• On/Off switch on control panel
• Power circuit breaker on service panel

Laser Emission Control

• Footswitch

Laser Emission Indicators

• Yellow lamp
• Audible buzzer

4.6.3. Cooling System • Closed-loop liquid-to-air cooling system

• Fluorinert FC-770 coolant

4.6.4. Electrical • 100-240 VAC, 9A, 50/60 Hz, single phase

Requirements

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System Description AcuPulse

4.6.5. Physical Dimensions and Weight

Specifications • Height of console: 118.5 centimeters (46.65 inches)
• Height with articulated arm at full vertical deployment:
245.5centimeters (96.65 inches)
• Width: 40 centimeters (15.75 inches)
• Depth: 40 centimeters (15.75 inches)
• Weight: ~50 kilograms (~110 pounds)

4.6.6. Environmental Ambient Temperature

Specifications • Operating: 5 to 30°C (41 to 86°F)
• Storage: (-20) to 70°C [(-4) to 158°F]

Relative Humidity
• Shipping & Operating: 5 to 85% relative humidity, non-condensing
• Shipping & Storage: 10 to 90% relative humidity, non-condensing

Atmospheric Pressure
• Operating: 70 – 106 kPa
• Storage: 70 – 106 kPa

4.6.7. System Type of Protection against Electric Shock

Classifications • Class I

Degree of Protection against Electric Shock for Applied Parts

• BF

Suitability for use in Presence of Flammable Mixture

• Not suitable

Protection against Ingress of Water

• IPX0

Mode of Operation
• Can be used continuously

4-16 UM-1091300, Rev. F

5.

Chapter 5
Operating Instructions

5.1. Introduction This chapter of the AcuPulse laser system operator’s manual describes
normal system operation. It includes:
• Pre-operation system preparation
• Operating the system via the graphic user interface

Instructions for system setup are included in Chapter 3 – Installation.

Maintenance and troubleshooting issues are detailed in Chapters 7 & 8 –
Maintenance and Troubleshooting. Chapter 6 – Delivery Systems –
lists and describes the use and care of the system's standard and optional
accessories.

Note

• Read this manual before performing any patient procedures. The

information in this manual should be used in conjunction with –
not as a substitute for – formal training.

• In Canada this instrument must be installed and operated

according to CAN/CSA-Z386-08: Laser Safety in Health Care
Facilities.

5.2. Safety Read Chapter 2 – Laser Safety – before attempting any procedures. Be
Considerations aware of the hazards when using lasers and take appropriate protective
measures. Some important reminders:

1. Restrict access to the laser operating area. Post the laser warning sign
before beginning any procedure.

2. Make sure that the laser operating area is safe and secure. Any
flammable materials should be moistened, or should be beyond contact
of the laser beam. All personnel and patient should wear protective
goggles or glasses.

3. Remember that the footswitch is enabled (allowed to operate the

system) when the system is in Ready mode. The footswitch is disabled
(not allowed to operate the system) when the system is in Standby
mode. When not actively lasing, set the system to Standby mode.

4. When the procedure is complete, turn off the system by following the
steps in Section 5.13.

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Operating Instructions AcuPulse

5.3. Starting the System

5.3.1. Before Turning Before you turn the system on, verify that:
On the System
1. The system is plugged into an appropriate power outlet.

2. The power circuit breaker on the service panel is turned to the On

position.

3. The laser stop button is not engaged. If it is, turn the button clockwise
to release it.

4. The footswitch is connected to the electrical connection panel.

5. The purge air tube is connected to its barb.

6. The wheel brakes are locked.

7. A delivery system accessory is connected to the articulated arm's

endjoint.

8. The patient and all other personnel in the room are wearing adequate
safety eyewear.

5.4. Operating the 1. Press the green On/Off switch on top of the system's console; the
System system starts its initialization process, during which a splash screen is
displayed on the LCD.

2. The Login screen will now appear (see Figure 5-1); insert the
password by pressing the numbered buttons on the screen's virtual
keypad. If you pressed a wrong button by mistake, press the button
with the  icon – this will clear the last character entered:
• User's initial password: 1234
• Administrator's initial password: 1808

Note
It is strongly recommended that the administrator change the initial
passwords as soon as possible.

3. Press the Login key in the top-right corner of the screen; a self-test
routine starts that checks out the system. If a fault is detected, the
system issues an appropriate error message (see Chapter 8). Once the
system satisfactorily completes the self-test routine, it is ready for
operation and displays the Home screen (see Figure 5-2).

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AcuPulse Operating Instructions

Figure 5-1: Login Screen

Note
To switch from one logged-in user to another or from the logged-in
administrator to a user, press the Logoff button; the Login screen
will reappear and an alternate user may log in with his/her
proprietary password.

Figure 5-2: Home Screen

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Operating Instructions AcuPulse

Figure 5-2 and the following sections offer explanations and rules of
navigation through the operator settings and operation of the AcuPulse
laser system.

Pressing each of the following buttons will take you to the appropriate area
of the operating system:

1. Manual Treatment – sets up the system to treat the patient with

manually-input operating parameters and a standard, non-scanning
handpiece (see Section 5.5.4).

2. SurgiTouch Treatment – sets up the system to treat the patient with

surgical accessories (see Section 5.5).

3. Aesthetic Treatment – sets up the system to treat the patient with

aesthetic accessories (see Section 5.7).

4. Atlas of Accessories – displays images and details of all Lumenis

laser accessories available for use with the AcuPulse system (see
Section 5.9).

5. Utilities – navigates to the screen where several of the system's

functional utilities may be accessed for reconfiguration (see
Section 5.11.).

6. Preferences – navigates to the screen where the user may change the
functionality of many of the system's operational and performance
settings (see Section 5.10).

7. Logoff – used for logging out of the system for shutdown, or to change
from one user to another, with or without administrator rights.

8. My Settings – navigates to the screen where the user may select any
of his/her proprietary treatment settings quickly and easily (see
Section 5.8.2).

9. User – the name of the currently logged-on user is displayed here.

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AcuPulse Operating Instructions

5.5. SurgiTouch
Treatment

5.5.1. Select Specialty Press the SurgiTouch Treatment button on the Home screen (see
Figure 5-2); the Select Specialty screen will appear (see Figure 5-3).

Note

• Refer to Chapter 6 – Delivery Systems – for a complete

discussion concerning the SurgiTouch accessory system.

• For complete operating instructions for the AcuScan120

accessory system, refer the AcuScan120 Microscanner
Operator's Manual (Lumenis catalog # UM-1044640).

The elements of the Select Specialty screen are (refer to the numbered
items in Figure 5-3).

1. Select Specialty – select the desired surgical specialty from the array
of buttons; the active specialty will be high-lighted and the system will
take you to the SurgiTouch Menu screen (see Section 5.5.2 and
Figure 5-4).

2. Remember my specialty – the user may choose to have the system

always remember his/her specialty, and go straight to that specialty
after login. Mark this checkbox by pressing it on the screen.

3. Home – press this button to return to the Home screen (see

Figure 5-2).

Figure 5-3: Select Specialty Screen

UM-1091300, Rev. F 5-5

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Operating Instructions AcuPulse

5.5.2. SurgiTouch The elements of the SurgiTouch Menu screen are (refer to the numbered
Menu items in Figure 5-4).
1. Selected Specialty Icon/Button – this icon indicates which specialty
is currently selected. It is also a button that when pressed, navigates
the system back to the Select Specialty screen (see Figure 5-3).

2. Application Icons/Buttons – this bar of icons displays all of the

SurgiTouch specific application modes available within the selected
specialty. The active application is highlighted, and the lower part of
the screen displays the accessories available for that mode. Pressing
any of the icons changes the selected application and with it also the
available accessories.

3. Select Accessory – the AcuPulse system is programmed to offer you

the Lumenis surgical CO2 laser accessories suitable for use with the
selected specialty and application. Scroll through this menu by
pressing the  or  buttons till you find the desired accessory, and
press the name of the accessory to select it.

4. Accessory Image Information – this window will display an image

of the selected accessory to confirm your selection. Press the image to
open a new screen that will display an associated video clip, showing
you how to connect and prepare the accessory for operation (see
Section 5.9).

5. Treatment – press this button after selecting the accessory to advance

to the Treatment screen (see Figure 5-5).

Figure 5-4: SurgiTouch Menu Screen – ENT

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AcuPulse Operating Instructions

6. View Procedure – pressing this button transitions to a new screen and

launches an associated video clip, exhibiting several Lumenis-
recommended methods of performing the selected application with
various accessories.

7. AcuPulse Presets – navigates to the screen where the user may select
Lumenis-recommended operating parameters for treatments associated
with the selected accessory (see Section 5.8.3).

8. Change Specialty – press this button to return to the Select

Specialty screen (see Figure 5-3) for the purpose of selecting a
different specialty.

9. Home – press this button to return to the Home screen (see Figure 5-2).

5.5.3. Treatment The elements of the Treatment screen are (refer to the numbered items in
Screen: Scan Figure 5-5).
Mode
1. Scan / No Scan – the system can be operated with no scan patterns
even if the SurgiTouch flashscanner is connected to the system. Select
the appropriate tab for scanning or non-scanning operations.

2. Selected Specialty Icon/Button – this icon indicates which specialty

is currently selected. It is also a button that when pressed, navigates
the system back to the Select Specialty screen (see Figure 5-3).

Figure 5-5: SurgiTouch Treatment Screen – Scan Mode

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Operating Instructions AcuPulse

3. Application Icon/Button – displays which SurgiTouch application is

selected. Pressing this button navigates back to the SurgiTouch Menu
screen (see Figure 5-4) in order to select a new application.
4. Selected Accessory Icon/Button – this icon displays which Lumenis
accessory is selected for use in the application. Pressing this button
navigates back to the SurgiTouch Menu screen are (see Figure 5-4) in
order to select a different accessory.

5. Laser Emission Mode – select CW (Continuous Wave), SuperPulse

or Pulser as the desired emission mode. The active mode is high-
lighted with a pink halo.

6. Timed Exposure Mode – select the desired type of laser beam

exposure: Repeat, Single or Continuous. The active mode is
highlighted with a pink halo.

7. Power Setting – set the desired laser power, measured in Watts:

• Press the  or  buttons to raise or lower the power setting in 1/2-
Watt increments between 1.0 – 10 Watts, and single-Watt
increments from 10 Watts and higher.
• Press anywhere on the power bar to immediately set that power
setting.
Note

• Due to the physical characteristics of the CO2 laser tube, when

the system is set to the lowest power and time settings, the
system may deliver less than the requested energy per pulse
setting (mJ).

• If this occurs, the following message will appear on the screen:

The delivered energy may be less than expected for this
setting.

• Press the OK button to accept this limitation, or Cancel to return

to Standby mode; change the settings on the screen:

⇒ In Scan mode: increase the scan size or depth settings as

necessary.

⇒ In No Scan mode: increase the Time-On setting as

necessary.

8. Recommended Power Setting – after selecting the specialty,

application & accessory, and transitioning to the Treatment screen,
the system will automatically set the laser power parameter to the
Lumenis-recommended setting. If you change this setting, a remark
will appear under the power bar stating the recommended setting.

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AcuPulse Operating Instructions

9. Scan Shape Selector – select the scan shape; scroll through the
shapes with the  or ▬ buttons until the desired shape is displayed.
The available shapes are: circle, square, ring, kidney, line and curved
line. Note that not all shapes are available for all accessories.

10. Shape Size Selector – select the size of the scanned shape; scroll
through the sizes with the  or ▬ buttons until the desired size is
displayed. Note that not all sizes are available for all accessories in all
modes.

11. Depth – select the depth of the scan; the depth is determined by the
number of scans pulsed at the same spot, the higher the number of
scans, the deeper the effect will be. Scroll through the number of
applied scans per pulse with the  or ▬ buttons until the desired
number is displayed (not available in Continuous mode).

12. Time Off – select the desired delay time interval between scans in
Repeat mode; scroll through the available intervals with the  or ▬
buttons until the desired interval is displayed (not available in Single
or Continuous modes).

Note

• The system's operational design is based on a train of consistent

pulse cycles, comprised of laser-emission and laser-paused
periods.

• The length of the pulse cycle is determined during the system’s

automatic power convergence.

• The user-selected Off-time (displayed on the screen) determines

the number of pulse cycles that will be blocked during the
continuity of laser beam emission.

13. # of Exposures – this setting governs the number of sequential scans

that will be emitted for as long as the footswitch is pressed. When that
number of scans has been emitted, the system will stop. To continue
scanning, release and re-press the footswitch.

14. Infinite – when this checkbox is marked (), the system will emit
sequential scans for as long as the footswitch is pressed.

15. Aiming Beam – determine the intensity of the aiming beam during
laser emission:

• Press the button to increase the intensity – all the way to full.

• Press the button to decrease the intensity – all the way to off.

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Operating Instructions AcuPulse

• Press the button to toggle between a continuous or blinking

aiming beam.

• Press the button to transition directly to the Beam Offset

screen.

16. Ready/Standby Buttons and Indicators –

• Press the Ready button to set the system to Ready mode.

• Press the Standby button to reset the system to Standby mode

Warning
Laser energy is radiated from the laser accessory when the
system is in Ready mode and the footswitch is pressed. Observe
laser safety rules – wear safety glasses!

17. My Settings – pressing this button offers direct access to the My

Settings screen (see Section 5.8).

18. Save – navigates to the Add Settings screen (see Figure 5-11) where
the user may designate and save protocols of operational settings as
user presets (see Section 5.8.1).

19. Message Area – short operational messages are displayed here.

20. Smoke Evac. – if a medical smoke evacuation system is connected to

the AcuPulse laser system (via the service panel), activation of this
button will turn on or shut off the smoke evacuator. The smoke
evacuator will also automatically turn on during laser beam emission.

21. Air Flow – activating or deactivating this button will toggle the purge
air compressor on or off. Activation of this button will toggle the air
flow to enabled or disabled modes during laser beam emission.

22. Home – press this button to return to the Home screen (see
Figure 5-2).

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AcuPulse Operating Instructions

5.5.4. Treatment To continue operating in the same specialty and application, using the
Screen: No Scan same accessory but without scanning, press the No Scan tab on the
Mode treatment screen (see Figure 5-6); the Shape and Shape Size selection
fields will become disabled, as will the galvanometric mirrors in the
SurgiTouch flashscanner.

Removing the SurgiTouch flashscanner is not necessary – the straight laser

beam will pass through the flashscanner without being modified.

Figure 5-6: SurgiTouch Treatment Screen – No Scan Mode

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Operating Instructions AcuPulse

5.6. Manual Treatment Press the Manual Treatment button on the Home screen (see Figure 5-2);
the Manual Treatment screen will appear (see Figure 5-7).

This is a treatment screen where you may set your own proprietary
parameter settings, regardless of which Lumenis accessory is connected to
the system.

Operating in the Manual Treatment screen is without scanning – note that

the Shape and Shape Size selection fields are disabled.

Any protocol of settings entered on this screen can be saved as a user

preset in My Settings (see Section 5.8).

Figure 5-7: Treatment Screen – Manual Settings

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AcuPulse Operating Instructions

5.7. Aesthetic Press the Aesthetic Treatment button on the Home screen (see
Treatments Figure 5-2); the Aesthetics Menu screen will appear (see Figure 5-8).

Figure 5-8: Aesthetics Menu Screen

1. Select the desired Application from the selection of buttons, and then
select the desired Lumenis accessory from the selection associated
with that application.

2. Press the Treatment button to transition to the appropriate Treatment

screen.

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Operating Instructions AcuPulse

3. If you have selected the SilkTouch, FeatherTouch, FineTouch,

ToeTouch, Paint or Bleph application, the appropriate Treatment
screen will appear (see Figure 5-9) with the selected application and
accessory.
The controls and indicators in these screens operate in the same
manner as those described in Section 5.5.3, earlier in this chapter.

Figure 5-9: Aesthetics Treatment Screen

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AcuPulse Operating Instructions

5.7.1. Fractional Refer to Figure 5-10: the four fractional applications – Deep (A),
Applications Superficial (B), Combo (C) and StretchTouch (D) – are available from
the Aesthetics Menu screen with (by default) the AcuScan120 accessory.
Selecting any of these modes will bring up the appropriate screen.

Figure 5-10: Aesthetics Treatment Screen: Deep, Superficial, Combo and StretchTouch

Note several major differences in the Fractional treatment screens:

• Instead of Power, you will adjust the Energy setting, measured in

milliJoules (mJ), with the ability to raise or lower the energy setting:

⇒ Deep fractional treatment energy may be adjusted in 2.5 mJ

increments between 7.5 to 30 mJ. The Lumenis-recommended
setting is 10 mJ (see Figure 5-10, view A).
⇒ Superficial fractional treatment energy may be adjusted in
10 mJ increments between 50 mJ and 170 mJ. The Lumenis-
recommended setting is 70 mJ (see Figure 5-10, view B).

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Operating Instructions AcuPulse

⇒ Combo mode offers the possibility of applying Deep and

Superficial modes at the same scan. View C in Figure 5-10
exhibits the parameter selection areas for both modes, within
the same energy ranges as described above.
⇒ StretchTouch fractional treatment energy may be adjusted in
1 mJ increments between 10 mJ and 25 mJ. The Lumenis-
recommended setting is 10 mJ (see Figure 5-10, view D).
• Instead of Depth, you will select the Density of the dots in the
scanned pattern:
⇒ Deep fractional treatment – between 5% – 25%, in 5%
increments.
⇒ Superficial fractional treatment – two settings are available:
40% and 60%.

⇒ StretchTouch fractional treatment – three settings are available:

5%, 10% and 15%.

Note
For complete operating instructions for the AcuScan120 accessory
system, refer the AcuScan120 Microscanner Operator's Manual
(Lumenis catalog # UM-1044640).

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AcuPulse Operating Instructions

5.8. User Presets

5.8.1. Programming The operating system offers every individual user the possibility of
User Presets creating proprietary presets. A preset is a protocol of operating parameters,
created by the clinician, and saved to the system with a name or
designation. The preset can then be rapidly recalled for operation without
having to enter each operating parameter.

After the user presets are programmed into the system's memory, they can
be quickly accessed and set for operation through the My Settings screen
(see Section 5.8.2).

User presets are programmed as follows:

1. Set up your desired operating parameters in any of the treatment
screens (for example Figure 5-5).
2. Press the Save button on the Treatment screen; the Add Settings
screen will appear (see Figure 5-11).
3. Use the virtual keyboard to type in a name for the procedure; the name
will appear in the Save As: box.
4. Press the Save button to save the preset to the system's memory; the
screen will transition back to the Treatment screen.

5. Press Cancel to exit the Add Settings utility without saving the
preset.

Figure 5-11: Add Settings Screen

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Operating Instructions AcuPulse

5.8.2. My Settings After the user presets are programmed into the system's memory (see
Section 5.8.1) they can be quickly accessed and set for operation through
the My Settings screen.

There are two ways to access the My Settings screen (see Figure 5-12):
• Press the My Settings button on the Home screen (see Figure 5-2).
• Press the access button on any of the Treatment screens.

1. Use the  or  buttons on the slider to scroll to the desired settings

preset. The display presents the name, the assigned Lumenis
accessory, specialty and application mode designations.

2. Press the desired preset to select it; it becomes highlighted.

3. Press the Treatment button; the system will transition to the

Treatment screen with all parameters of the preset in place and ready
for operation.

4. If you wish to assign a new name to the preset, press the Rename
button; the virtual keyboard will appear where you can type in the new
name and save by pressing the Save button.

5. Press the Delete button to permanently remove the highlighted user

preset from the system's memory.

Figure 5-12: My Settings Screen

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5.8.3. Fix Settings Determining treatment parameter settings for a particular combination of
clinical indications is a result of clinical experience and expertise.

For the convenience of the user, the AcuPulse system is furnished with a
set of Lumenis presets of treatment parameters, called Fix Settings. These
presets are based on successful results obtained by experienced physicians
using CO2 laser systems.

The Fix Settings screen (see Figure 5-13) is accessible by pressing the Fix
Settings button on the My Settings screen (see Figure 5-12).

Here you may view and select any of the Lumenis-recommended operating
parameters for various laser procedures. Scroll through the selection with
the  or  buttons on the slider. The display presents the name of the
preset, the assigned Lumenis accessory, specialty and application mode
designations.

When you locate the desired procedure, press its name to select (highlight)
it and press the Treatment button; the appropriate Treatment screen will
appear with all parameters of the preset in place and ready for operation.

To exit this screen without selecting a fixed Lumenis preset, press the
My Settings button to return to that screen (see Figure 5-12) or press the
Home button.

Note
Fixed Settings cannot be renamed or deleted from the system's
memory.

Figure 5-13: SurgiTouch Presets Screen

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5.9. Atlas of The AcuPulse operating system's software incorporates a complete atlas of
Accessories Lumenis accessories designed for use with the Lumenis family of CO2
surgical laser systems. The atlas is accessible from the Home screen (see
Figure 5-2) by pressing the Atlas of Accessories button.
In the atlas screen (see Figure 5-14) you may view and perform the
following:
1. Select the Specialty and Application within which you want to view
the accessories available for use. Use the drop-down menus to make
these selections.
2. Scroll through the selection of accessories with the  or  buttons on
the slider until you find the one you are interested in.
3. When you have found the desired accessory, press its name to
highlight it and press the View Details button; this will bring up an
Accessory Description screen offering an image and detailed
information about the accessory. Press the image to open a new screen
that will display an associated video clip, showing you how to connect
and prepare the accessory for operation.
4. Pressing the View Procedure button transitions to a new screen and
launches an associated video clip, exhibiting several Lumenis-
recommended methods of performing the selected application with
various accessories.
5. Press the Treatment button; the appropriate Treatment screen will
appear with all parameters of the Specialty and Application in place
and ready for operation with the selected accessory.

Figure 5-14: Atlas of Accessories Screen

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5.10. Preferences To configure the AcuPulse system's software and hardware preferences,
press the Preferences button on the Home screen (see Figure 5-2); the
first of three preferences screens will appear.

5.10.1. General This is the default preferences screen that appears, and this is where you
Preferences can make changes to several general system settings (refer to the
numbered items in Figure 5-15):

1. Access buttons to the secondary preferences screens: Air Flow (see

Section 5.10.2) and Sound (see Section 5.10.3).

2. Language – open the drop-down menu to select the desired language

in which the Note, Caution and Warning pop-up windows will be
displayed. The available languages are: English, German, French,
Spanish, Italian, Japanese, Chinese and Portuguese.

3. Show Smoke Evacuation Button – mark this checkbox to offer the

smoke evacuator option button in the Treatment screens. If you never
plan to use a smoke evacuator, leave this checkbox unmarked.

4. Automatic Standby – this is a safety timer that resets the system from
Ready to Standby mode if the system is idle for more than a user-
defined time limit, to prevent unintentional activation of the laser with
the footswitch. Set the desired time interval with the  or ▬ buttons.

5. Brightness – increase or decrease the LCD screen's brightness setting

with the  or ▬ buttons until you reach your comfort level.

Figure 5-15: General Preferences Screen

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6. Restore Factory Defaults – press this button to reset all of the

system's software and hardware preferences to their original factory
settings.

7. OK – press this button to save the changes to the preferences and exit
the Preferences screen back to the Home screen.

8. Cancel - press this button to exit the Preferences screen without

changes.

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5.10.2. Air Flow Press the Air Flow button on the General Preferences screen to adjust the
Preferences performance features of the purge air compressor (refer to the numbered
items in Figure 5-16):

1. Show Air Flow Button – mark this checkbox to offer the air flow
option button on the Treatment screens. If you never plan to use
compressed purge air, leave this checkbox unmarked.

Air Flow While in READY:

2. Automatic Control – mark this checkbox to enable the air flow setting
to operate automatically during laser procedures.

3. Air Flow While Lasing – mark this checkbox if you want the purge air
to flow during laser emission.

Air Flow While Not Lasing – mark this checkbox if you want the
purge air to flow constantly while the system is in Ready mode, even
if you are not lasing at the time.

4. After Lasing – the purge air can be configured to keep flowing after
the footswitch is released and laser emission has ceased for a
determined amount of time; increase or decrease the time interval
setting with the  or ▬ buttons until you reach the desired interval.

Figure 5-16: Air Flow Preferences Screen

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5.10.3. Sound Press the Sound button on the General Preferences screen to adjust the
Preferences performance features of the system's audible alerts (see Figure 5-17):

1. Four occurrences of system operation may be accompanied by audible

sound alerts. Select the occurrences you want sound alerts for, and
mark them to activate the alert features by pressing their checkboxes.

2. Increase or decrease the sound alert's volume setting with the  or ▬

buttons until you reach the desired level.

Figure 5-17: Sound Preferences Screen

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5.11. Utilities Menu The Utilities Menu screen (see Figure 5-18) is accessed by pressing the
Utilities button on the Home screens (see Figure 5-2), and offers the
following:
• Software Configuration – an information block displaying the
currently installed versions of the system's various software packages.
• System Configuration – information regarding the system's
hardware components.
• Scanner Disconnect – see Section 5.11.1.
• New Scanner – see Section 5.11.2.
• Service – available only in Technician mode. This area may only
be accessed by Lumenis-authorized service personnel.
• Cnfg. Upgrade – for upgrading the system's hasp plug. Available in
User mode and Technician mode (see Chapter 7 - Maintenance).
• Data Base Backup – for periodic backing up of the user-developed
database from the system (see Section 5.11.4).

Figure 5-18: Utilities Menu Screen

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5.11.1. Disconnecting the Before disconnecting the scanning accessory at the endjoint of the
Scanner articulated arm, the scanner software module needs to be paused in order
to prevent possible damage to the system.

Pause the scanner software module by pressing the Scanner Disconnect

button; a pop-up window will appear stating: It's safe now to disconnect
scanner (see Figure 5-19).

Disconnect the communication cable from the scanning accessory and

disconnect the accessory from the articulated arm.

Figure 5-19: Disconnect Scanner Pop-Up Message

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5.11.2. Installing a New Lumenis offers several types of scanners for the AcuPulse system as
Scanner optional accessories. When purchased, it arrives with proprietary
installation software on a dedicated USB flash drive ("disk-on-key"). To
install:

1. Connect the new scanner to the articulated arm's endjoint and connect
the communication cable.

2. Connect the USB flash drive to either of the USB connection ports on
the system's service panel.

3. Turn on the system and access the Utilities Menu screen (see
Figure 5-18). Press the New Scanner button.

4. When the Welcome to new scanner Upgrade! pop-up window is

displayed (see Figure 5-20), follow the on-screen instructions to install
the new scanner's software.

5. When the installation is complete, remove the USB flash drive and
restart the AcuPulse system.

Figure 5-20: New Scanner Upgrade Pop-Up

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5.11.3. Users List The Users List screen is only accessible when the administrator is logged
into the system. The administrator may add a new user, edit a user's
information, and delete a user.

Refer to Figure 5-21:

1. To add a new user, press the Add User button; the Add User screen
will appear (see Section 5.11.3.1).

2. To edit a user's details, scroll with the  or  buttons to find the

user's name, press the name to highlight it and press the Edit User
button; the Edit User screen will appear (see Section 5.11.3.2).

3. To delete a user, scroll with the  or  buttons to find the user's

name, press the name to highlight it and press the Delete User button;
the user will be permanently removed from the system's memory.

Figure 5-21: Users List Screen

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5.11.3.1. Add User

To add a new user's information:

1. Press the User Name field to activate it, and use the virtual keypad to
enter the new user's name.

2. Do the same in the Password field. Make sure that every individual
user has his/her own proprietary password.

3. If the new user is to have administrator rights, mark the Administrator

checkbox by pressing it.

4. Press the Save button to accept the new information, or Cancel to

reject.

Figure 5-22: Add User Screen

Note
If an attempt is made to enter a new user with the same credentials
as an existing one, the system will consider this an error and display
the following message: Failed to add user. Check if name and
password are valid.

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5.11.3.2. Edit User

To edit an existing user's information:

1. Press the User Name field to activate it, press the  key to erase the
existing name and use the virtual keypad to enter the new or corrected
name.

2. Do the same in the Password field. Make sure that every individual
user has his/her own proprietary password.

3. If the edited user is to have (or lose) administrator rights, mark or un-
mark the Administrator checkbox by pressing it.

4. Press the Save button to accept the new information, or Cancel to

reject.

Figure 5-23: Edit User Screen

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5.11.4. Database Backup

The Database Backup utility is designed to safeguard the database of
information that is developed and stored in the AcuPulse system's
memory, such as names, passwords and ID's of the various users, and all
of the proprietary protocols of operating parameters stored in the system
(My Settings) by the users.

To back up the database:

1. Insert a USB flash drive (disk-on-key) into one of the USB ports in the
system's service panel (see Chapter 4).

2. Press the Data Base backup button on the Utilities screen (see
Figure 5-24).

3. Follow the on-screen instructions until the backup procedure is

complete.

Figure 5-24: Database Backup Screen

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5.12. System Messages The AcuPulse system employs pop-up windows to deliver important
information, error messages or warnings relevant to unintended misuse of
the system or a possible internal malfunction.

There are three types of pop-up messages:

Information Dialog – offers important information specific to the given

situation.

Error Message – offers details of a system malfunction or a non-

functional setup. The problem should be resolved before continuing with
the treatment.

Warning Dialog – warns against a serious system malfunction that can

create a health hazard to the patient or operator. The system must be shut
down and the problem resolved before using the system again.

5.13. System Shut-Down 1. Press the Home button on any screen in the operating system to return
to the Home screen.

2. Press the Logoff button to log out of the operating system.

3. Turn the system off by pressing the green On/Off switch on top of the
system's console.

4. Turn the power circuit breaker switch on the service panel to the Off
position.

5. Clean/sterilize the surgical accessories (refer to Chapter 6).

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6.

Chapter 6
Delivery Systems

6.1. Introduction This chapter discusses the delivery systems and accessories that are
designed to operate with the AcuPulse laser system.

The following sections will describe the accessories and discuss their
components, operation, care and maintenance.

6.2. 125mm Incisional The 125mm incisional handpiece set is the standard laser accessory
Handpiece Set delivered with the AcuPulse system.

The CO2 laser beam focal point is indicated by the straight tip on the
handpiece. With the 90° and 120° reflector tips, the focal point is 1cm
distal to the reflecting mirror. The spot size for the handpiece is 0.26mm.

The 125mm incisional handpiece set includes:

Description Qty. Part #
125mm lens holder, including the lens 1 AA0742900
125mm extender 2 AA2171600
Straight focus-indicating tips 2 PM0163930
90° reflector tip 1 AA0198900
Figure 6-1: 120° reflector tip 1 AA0198800
125mm Incisional
Handpiece Endjoint cap, attached to the articulated arm's endjoint to prevent dust
from entering the endjoint when an accessory is not attached.

6.2.1. Handpiece To assemble the 125mm incisional handpiece (see Figure 6-1):
Assembly 1. Screw the lens holder into the articulated arm's endjoint connection.
2. Connect the bacteriological filter's outlet (short flexible tube) to the
compressed air nipple on the lens holder.
3. Prior to use, whether or not already installed, the bacteriological filter
should be inspected for clarity of color.
4. Screw the extender into the lens holder.
5. Screw the desired tip (straight tip; 90° or 120° reflector tip) into the
extender and ensure that all the connections are tightly secured.
6. Check for proper beam alignment before treating a patient (see
Section 6.5).

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6.3. FeatherTouch The FeatherTouch handpiece set (Model # 15100, P/N # AA2775200)
Handpiece Set contains three handpieces used with the SurgiTouch scanner, mostly for
aesthetic applications, and is normally provided as standard equipment
with any aesthetic configuration of the AcuPulse system.

The FeatherTouch handpiece set contains:

Description Model # Part #

125mm handpiece with Smoke Evacuation 15128 AA2814900
200mm SilkTouch Handpiece 15211 AA2778200
260mm SilkTouch Handpiece 15261 AA2782600
Straight Focus-Indicating Tip for 125mm Handpiece PM5116930
Straight Focus-Indicating Tip for 200mm Handpiece PM5085230
Straight Focus-Indicating Tip for 260mm Handpiece PM5052830
Smoke Evacuation Tip for 125mm Handpiece AA5125900
Smoke Evacuation Tip for 200mm Handpiece AA2775600
Smoke Evacuation Tip for 260mm Handpiece AA2775700
Cleaning Brush MD1651400

6.4. Scanning Two scanning accessories are available for use with the AcuPulse system:
Accessories AcuScan120 and SurgiTouch. Each of these accessories consists of
flashscanner and user interface software built into the AcuPulse system's
operating program, with pre-set recommendations for parameters and
delivery devices. The AcuScan120 and SurgiTouch scanners are the same
in design and the way they are controlled by the AcuPulse system.

The AcuScan120 Microscanner and its procedures deliver laser energy in

a fractional technique via a scanner for rapid coverage of large surface
areas. A "fractional" technique is one where the physician can selectively
treat less than 100% of the skin's surface (a fraction). Depending on the
condition to be treated, the physician may select to use either a superficial
or deep treatment modality, within which different treatment densities
(how much skin is covered) and energy settings (for different depths,
different amounts of heat/ablation, etc.) can be selected. This allows the
physician to "optimize" the treatment according to each patient's condition.
By minimizing/eliminating the previous compromise between treatment
efficacy, down-time, pain management, side-effects, observable results
and other factors; the physician can now bridge the gap between the
patient's expectations and their results.

The AcuScan120 microscanner's control screens and scanner provide

precise control over the laser energy, the beam scan shape, beam scan size
and beam scan density.

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The SurgiTouch Scanner is designed for a variety of applications, in

aesthetics, ENT, gynecology, neurosurgery and general surgery.
The unique scanning mechanism of the SurgiTouch scanner delivers a
focused laser beam with constant velocity in a spiral pattern (see
Figure 6-2) over a designated scan area. Laser energy is delivered so
quickly that it never lingers on any given point in the scan longer than the
thermal relaxation time of tissue, resulting in char-free ablation and
predictable, repeatable vaporization.

Figure 6-2: SurgiTouch Beam Scanning Pattern

The SurgiTouch Scanner uses multiple devices depending on the surgical

or aesthetic application it is used with.
The AcuPulse system's user-friendly graphic display provides step-by-step
operating instructions, shows the correct accessories and operating
parameters for each procedure, and keeps the user in control of the
procedure at all times. The SurgiTouch scanner can be used with the
Lumenis delivery devices listed later in this chapter.

6.4.1. SurgiTouch The SurgiTouch scanner kit (P/N # KT-1000100) contains:

Scanner Kit • SurgiTouch scanner (includes scanner & handpiece assemblies).
Contents
• Communication cable (P/N # SPHS-1023010).
• AcuPulse system software upgrade on USB flash drive.

6.4.2. Scanning Refer to the respective operator's manual of each scanning accessory
Accessories system for complete pre-operative, operating and post-operative
Operator Manuals instructions.

Warning

Replace the AcuScan120's lens assembly after

10 treatments or before if the lens assembly is stained or
otherwise damaged.

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6.4.3. Setting up a Setting up the scanner requires the connection of the optical head to the
Scanning articulated arm's endjoint; connecting the communication cable and
Accessory System connecting the accessory to the optical head (see Figure 6-3):

1. Connect the scanner optical head's entry port to the endjoint of the
laser system's articulated arm, and fasten it by screwing the end-joint's
rotating knob until it stops.
Caution
The scanning accessory's software module must be paused when
connecting or disconnecting a scanner accessory. Refer to
Chapter 5 – Utilities Menu screen.

2. The exit port is a swivel connector that allows free rotation of the
handpiece. If free rotation is not required, simply lock the lever on the
exit port.
3. Connect the communication cable between the optical head and the
system cable connection port on the AcuPulse system's control panel.
4. Route the communication cable along the articulated arm and attach it
to the arm's segments with the supplied clips.
5. Connect the desired accessory to the optical head's exit port.

Figure 6-3: Setting Up the Scanning Accessory (for illustration purposes only)

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6.4.4. Cleaning the The AcuScan120 and SurgiTouch optical heads are intended to be used as
Optical Heads non-sterile devices. The external surfaces may be cleaned with a cloth or
cotton swab dipped in hospital grade 70% alcohol.

6.5. Beam Alignment Most nursing staff prefer to perform a laser beam alignment check daily,
Check usually prior to scheduled cases and before patients are premedicated.
Doing so ensures adequate time to troubleshoot a problem or seek
professional service with the least disruption to patient care.

Warning

• Beam alignment checks are extremely important for

the safe operation of your laser equipment. Do not use
the laser or delivery system if aiming and treatment
beams are not coincident; call your local Lumenis
representative. Misalignment of aiming and treatment
beams may result in laser exposure to nontarget
tissues and possible injury.
• Do not perform the beam alignment check in line with
the patient, operating room personnel, or flammable
materials. Laser energy can penetrate most non-
metallic and non-laser-proof substances and ignite
underlying flammable material, resulting in possible
injury. If necessary, place energy-absorbing material
behind the target area.

Perform the beam alignment check as follows:

1. Verify that all persons in the treatment room are wearing appropriate
laser safety eyewear.

2. Mark an “X” on a wooden tongue depressor and moisten with water.

3. Turn on the laser.

4. Connect the 125mm incisional handpiece to the articulated arm's

endjoint.

5. Access the Manual Treatment screen, and set the laser's operating
parameters as follows:
• Laser mode: CW
• Exposure mode: Single
• Power: 2.0 Watts
• Time on: 0.10 sec
6. Press the Ready button to set the laser to ready mode.

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7. Position the distal end of the accessory's tip on the tongue depressor in
a perpendicular orientation. Adjust the aiming beam intensity on the
laser until the aiming beam is bright enough to be viewed under
normal ambient light.

8. Direct the aiming beam at the center of the “X”, and press the laser
footswitch. Observe the burned spot on the tongue depressor; it should
appear sharp and non-diffused.

9. Verify that the burn spot lies within the area of the aiming beam's red
outline (see Figure 6-4).

Aiming Beam Burn Spot: Burn Spot: Burn Spot:

Spot Perfect Alignment Acceptable Alignment Unacceptable Alignment

Figure 6-4: Beam Alignment Check Results

10. Press the Standby button to set the laser to Standby mode until ready
for use.

11. If the burn is not within the aiming beam, if the spot placement is
unacceptable, or if the aiming beam is not visible:
• Verify that the accessory is securely attached to the articulated
arm.
• It may be helpful to move the articulated arm or rotate the
articulated arm knuckles closest to the accessory. Sometimes
changing the orientation of the articulated arm knuckles can affect
aiming beam transmission, particularly if the articulated arm is
extended or moved during a procedure.
• If the brightness of the aiming beam fluctuates greatly or if the
aiming beam is not visible, the laser articulated arm may be out of
alignment; contact your local Lumenis representative.
• Repeat the beam alignment procedure. If the beam alignment is
still unacceptable, contact your local Lumenis representative.

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6.6. Optional The following table offers a list of Lumenis CO2 laser surgical and
Accessories aesthetic accessories that may be used with the AcuPulse system. Contact
your Lumenis distributor for in-depth information concerning any of these
accessories:
• SurgiTouch Scanner
• AcuScan120 Microscanner
• Digital AcuBlade
• Laser Bronchoscope
• Multi-Application / Oral Pharyngeal Handpiece Set
• LAUP (Laser Assisted Uvulopalatoplasty) Handpiece
• FeatherTouch Handpiece Set
• Nasal Probe Set
• Laryngeal Probe Set
• OtoLAM System (with NTSC or PAL video monitors)
• 125mm Incisional Handpiece
• Skin Resurfacing Handpiece Set for SurgiTouch;
Scanner Handpieces: 125mm – spot size ~0.25mm
200mm – spot size ~0.4mm
260mm – spot size ~0.6mm
• AcuSpot 712 Micromanipulator
• AcuSpot 712L Micromanipulator (dedicated to Leica
microscopes)
• AcuSpot 712Z Micromanipulator (dedicated to Zeiss microscopes)
• Microslad Models: 715, 716, 717, 718 and 719
• ColpoSlad Models: 725 and 726
• 300mm BeamAlign Coupler
• 200mm BeamAlign Coupler
• BeamAlign Alignment Kit
• Single Puncture Laparoscopic Set
• Second Puncture Laparoscopic Set

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6.7. Cleaning, Sterilization and High-level Disinfection

Caution
The instructions given in this section are not applicable to optical
or electronic components, such as the SurgiTouch optical head.

6.7.1. General Proper infection control techniques for a delivery accessory depend on the
degree of risk and patient contact involved in the use of that accessory.
This section discusses proper techniques for the accessories identified in
this chapter as "reusable and sterilizable", primarily external handpiece
components.

The system's console should be cleaned with a clean cloth and a mild
detergent. The LCD control panel should be cleaned periodically with a
dedicated LCD cleaning solution, available from any office supply store.

Other sterilization and disinfection techniques than those detailed may be

equally effective. It is the responsibility of the clinical user to validate
alternative techniques.

Proper sterilization or disinfection always starts with disassembly,

followed by cleaning.

6.7.2. Deciding on All components identified as reusable and sterilizable may have either a
Sterilization or sterilization or high-level disinfection process applied. Selecting which is
High-level appropriate is based upon the degree of risk involved with its usage in your
Disinfection clinical application.

Refer to the list below to determine the appropriate risk category of each
accessory:

Critical items – sterilization is required for instruments or objects that are

introduced directly into the bloodstream or into other normally sterile areas
of the body.

Semi-critical items – when a noninvasive tool comes into contact with

intact mucous membranes, but doesn’t penetrate a body surface, a high-
level disinfection procedure is recommended as a minimum precaution.
Sterilization can also be used, and may be very cost-effective. In most
cases, meticulous physical cleaning followed by an appropriate high-level
disinfection treatment gives the user a reasonable degree of assurance that
the items are free of pathogens.

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Non-Critical Items – non-critical items are those that either do not

ordinarily touch the patient or touch only intact skin. These items rarely, if
ever, transmit disease. Consequently, depending on the particular piece of
equipment or item, washing with a detergent may be sufficient.

• SurgiTouch Scanner – Non-Critical

• AcuScan120 Microscanner – Non-Critical
• Digital AcuBlade – Non-Critical
• Laser Bronchoscope – Critical
• Multi-Application / Oral Pharyngeal Handpiece Set – Critical
• LAUP (Laser Assisted Uvulopalatoplasty) Handpiece – Critical
• FeatherTouch Handpiece Set – Critical
• Nasal Probe Set – Critical
• Laryngeal Probe Set – Critical
• OtoLAM System (with NTSC or PAL video monitors) – Semi-Critical
(only the speculums)
• 125mm Incisional Handpiece – Critical
• Skin Resurfacing Handpiece Set for SurgiTouch (Scanner Handpieces
125mm, 200mm, 260mm) – Critical
• AcuSpot 712 Micromanipulator – Non-Critical
• AcuSpot 712L Micromanipulator (dedicated to Leica microscopes) –
Non-Critical
• AcuSpot 712Z Micromanipulator (dedicated to Zeiss microscopes) –
Non-Critical
• Microslad Models: 715, 716, 717, 718 and 719 – Non-Critical
• ColpoSlad Models: 725 and 726 – Non-Critical
• 300mm BeamAlign Coupler – Non-Critical
• 200mm BeamAlign Coupler – Non-Critical
• BeamAlign Alignment Kit – Non-Critical
• Single Puncture Laparoscopic Set – Critical
• Second Puncture Laparoscopic Set – Critical

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6.7.3. Repeated The identified components may be sterilized or disinfected repeatedly until
Sterilization or visual inspection detects corrosion, warping, or any corruption of the metal
High-level surface.
Disinfection
Caution
Do not reuse if components show signs of corrosion, warping, or
corruption of the metal surface.

6.7.4. Cleaning After disassembly, use the following cleaning techniques before
Procedure sterilization or disinfection.

1. Use proper biosafety techniques. Wear waterproof, disposable gloves

when handling contaminated parts.

2. Contain soiled components and transport to sterilization work site.

3. Wipe any visible contaminants off the components using a soft gauze
pad.

4. Prepare a liquid enzyme-based presoak for medical appliances by

dissolving 1 oz. (30 ml) of the solution with 1 gallon (3.8 liters) of
cold tap water.

5. Immerse the components in the prepared presoak solution.

6. Soak the components for two minutes.

7. Remove and rinse components thoroughly with cold, running tap

water.

8. Prepare a medical instrument detergent cleaner by dissolving ½ oz.

(15 ml) of the solution with one gallon (3.8 liters) of cold tap water.

9. Clean the components while immersed by brushing with a soft-bristled

brush. Pay close attention to crevices, and hard-to-clean areas.

10. Use a cotton-tipped swab to clean internal channels.

11. Rinse thoroughly with cold tap water.

12. Air-dry or blot dry with a soft cloth.

Note
To help ensure proper sterilization, it is best to clean parts
immediately following use.

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AcuPulse Delivery Systems

6.7.5. Sterilization Steam sterilization using the following procedure is recommended:

Techniques
1. Place cleaned components in a sterilization container or instrument
tray. Components placed on a perforated metal tray must be wrapped
in gauze or an instrument wrap.

2. Load and operate the steam sterilizer according to the following

guidelines:
• Sterilizer Type: Gravity Displacement
• Temperature: 250°F / 121°C
• Method: Wrapped
• Sterilization Time: 50 minutes
• Drying Time: 40 minutes
Note

• Sterility Assurance Level (SAL) is 106 (6 log reduction).

• Flash sterilization is not recommended.

6.7.6. High-level For high-level disinfection, the following procedure is recommended:

Disinfection
Techniques 1. Clean components as described in Section 6.7.4.

2. Prepare a liquid enzyme-based presoak for medical appliances

according to the manufacturer’s instructions.

3. Place cleaned components into a sterile container.

4. Add a high-level disinfection solution to the container, covering the

components.

5. Allow components to soak in solution for 45 minutes.

6. Pour off the disinfection solution and cover the components with
sterile distilled water.

7. Rinse the items thoroughly with sterile distilled water.

8. Allow components to air-dry.

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Delivery Systems AcuPulse

6-12 UM-1091300, Rev. F

7.

Chapter 7
Maintenance

7.1. Introduction This chapter contains the maintenance instructions for the AcuPulse laser
system. Routine maintenance may be performed by clinic staff unless
otherwise specified. Any maintenance procedure not mentioned in this
chapter must be performed only by Lumenis-authorized technical
personnel.

Note
Calibration procedures described in this chapter should be
performed only by qualified service personnel. See warning in
Section 7.6.

7.2. Service In communications with authorized Lumenis representatives regarding the

Information system, always include the model and serial numbers from the
identification label located on the system's rear panel (refer to the Safety
chapter of this manual).

Questions or problems should be referred to your Lumenis representative.

Warning

• Unauthorized servicing or modification of this system, not

described in this manual, may expose the operator/patient to
potential electrical energy and laser radiation hazards.

• Improper use or adjustment of this system may invalidate the

service warranty agreement.

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Maintenance AcuPulse

7.3. Routine Periodic Regular cleaning, inspection, testing, and repair are the basis of any
Maintenance effective preventive maintenance program. Such a program helps keep the
system in top working order and ensures the reliability of safety interlocks
and failsafe mechanisms.

A recommended routine inspection and maintenance schedule is provided

in Table 7-1:

Table 7-1: Recommended Routine Inspection and Maintenance Schedule

Inspection / Service Frequency Performed By Remarks

Disinfect / sterilize the non-
Before each procedure. Clinic Staff
scanning accessories.
Accessories cleaning and
After each procedure. Clinic Staff
maintenance.
Routine exterior cleaning. As required by clinic protocol. Clinic Staff
If no air flow, replace
Purge air flow check. Daily Clinic Staff
bacteriological filter.
Inspect accessories,
If damage is found,
handpieces, cables and all Weekly Clinic Staff
call Lumenis Service.
external surfaces for damage.
Inspect electrical connections. Weekly Clinic Staff
If interlock and button
Check door interlock and do not perform as
Annually Clinic Staff
laser stop button. required, call
Lumenis Service.
Must be performed
Annually (or as required by only by Lumenis-
Electrical safety checks. Lumenis Service
institutional procedures). authorized technical
personnel.
Annually, or as required if Must be performed
Check and perform power system does not perform to only by Lumenis-
Lumenis Service
meter calibration procedures. specifications, or occurrence authorized technical
of error messages. personnel.
After 10 treatments or before
AcuScan120 microscanner
if the lens assembly is stained Clinic Staff
lens assembly replacement.
or otherwise damaged.

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AcuPulse Maintenance

7.4. Lumenis Service Customer-performed maintenance is limited to the procedures contained in

Section 7.5. – Clinic Staff Maintenance.

The service procedures described in Section 7.6. – Professional

Maintenance detail the preventive maintenance procedures that must be
performed only by Lumenis-authorized technical personnel.

Lumenis Service should also be contacted when service is required for

correction of any problem or system fault listed in the troubleshooting
tables.

If the AcuPulse must be shipped for service, follow the shipping

instructions in Section 7.9.2. Always repackage the system using the
original packaging materials.

Caution
Do not ship the system without the factory packaging materials.
Doing so may result in damage to the components during shipping
and void the warranty. Contact Lumenis if packaging materials or
repackaging instructions are needed.

7.5. Clinic Staff Maintenance

7.5.1. Visual Inspection The exterior of the system should be inspected once a week to ensure that
there are no loose cable connections and that there is no damage to the
system.

7.5.2. Routine Exterior The external surfaces of the system (console, LCD panel and articulated
Cleaning arm) and the footswitch should be cleaned when the system is received,
and thereafter as required by clinic protocol.

The outer surfaces of the system may be wiped clean with a soft, lint-free
cloth dipped in 70% isopropyl alcohol, or a hospital-grade disinfectant
solution.

The LCD panel should be cleaned with a dedicated LCD cleaning liquid,
available in most office supply stores.

7.5.3. Safety Interlock The two safety interlocks to be checked are:

Checks • Door Interlock (see Section 7.5.3.1.)
• Emergency Stop Button (see Section 7.5.3.2.)

UM-1091300, Rev. F 7-3

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Maintenance AcuPulse

7.5.3.1. Door Interlock Laser beam emission is disabled when the door interlock plug is not
connected or is improperly connected to the service panel, even if it is not
wired to an actual door interlock. To check this:

1. Set the system to Standby mode.

2. Unplug the door interlock plug.

3. Try to select Ready mode; the system should display the following
error message: Remote Interlock Fault, Please verify Treatment
Room door is closed.

4. If the system does not display the error message and remains in Ready
mode, discontinue use and contact Lumenis Service.

7.5.3.2. Laser Stop Button The Laser Stop Button is designed to disable the laser when pressed.
Check
To check this interlock:

1. With the system On, press down on the laser stop button; the system
will reset itself to Standby mode.

2. Turn the button clockwise to release it; the system will automatically
return to Standby mode.

3. Press the Ready button on the LCD to enable lasing.

If this is not the situation, discontinue use and contact Lumenis Service.

7.5.4. Purge Air Flow Check the purge air flow as follows:
Check
1. Turn on the system.

2. Set the power to 0.5 Watts.

3. Select CW exposure, continuous wave mode.

4. Remove the air tube from the connection nipple on the system's
control panel.

5. Ensure that the system's preferences are set to deliver purge air while
the system is in Ready mode, without lasing.

6. Set the system to Ready mode and check that there is air flow from
the nipple.

If there is no air flow, contact Lumenis Service.

7-4 UM-1091300, Rev. F

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AcuPulse Maintenance

7.6. Professional This section covers checks, calibrations and maintenance that require
Maintenance internal access to the AcuPulse console and special skills.

Warning
These procedures demand specific knowledge, training and
use of tools not available to repair personnel outside of
Lumenis. Since performing these procedures may expose the
user to potential electrical and laser energy hazards, Lumenis
requires that these procedures only be performed by trained
service personnel.

7.6.1. Power Meter Power meter check and calibration must be performed by an engineer or
Calibration technician qualified to work with laser equipment. Questions regarding
this procedure should be referred to your local Lumenis representative.

Disclaimer warning:
Calibration is a service procedure to be performed only by Lumenis-
certified service engineers. Adjustment by anyone other than a trained
Lumenis service engineer voids any existing manufacturer's warranty on
the instrument. It is company policy not to distribute service tools outside
of the Lumenis Service Organization. Possession of service instructions or
tools does not authorize repair or modification of a Lumenis instrument by
uncertified personnel.

7.6.1.1. Internal Power The AcuPulse incorporates an internal power meter which is used for
Meter Check display and control of lasing energy. The power meter check compares the
internal power meter reading to the reading from an external power meter.

Note
Optical components must be clean before the power meter check is
performed.

Warning
• All personnel in the immediate area must wear eye protection
rated specifically for the CO2 laser.
• An out-of-calibration power meter will cause power delivery to
tissue to be different than that displayed.

UM-1091300, Rev. F 7-5

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Maintenance AcuPulse

The power meter check procedure is performed as follows:

1. Ensure that all personnel are wearing the appropriate laser safety
eyewear.

2. Position a calibrated, external power meter 15 cm (6 inches) from the

output end of the laser articulated arm.

3. Turn on the laser as instructed in Chapter 5 – Operation – of this

manual.

4. Access the Manual Treatment screen.

5. Set the laser system to CW mode, Continuous wave and 5 Watts of

delivery power.

6. Target the aiming beam at the external power meter's thermopile disc.

7. Set the laser system to Ready mode.

8. Press the footswitch to deliver the laser energy into the external power
meter's detector disc. Maintain delivery of the laser energy for
20 seconds.

9. Release the footswitch and record the power meter's reading.

10. Repeat steps 4 through 8 at power settings of 10, 15, 20, 30 & 40 Watts.

11. If the external power meter reading falls above or below ±20% of the
requested power on your laser, discontinue this procedure and contact
your local Lumenis service representative.

7-6 UM-1091300, Rev. F

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AcuPulse Maintenance

7.7. Software Upgrade Contact your local Lumenis representative for information concerning
available software feature upgrades.

7.8. HASP Upgrade After performing any feature upgrade to the system, the system's HASP
utility needs to be upgraded as well. These upgrades include among others:
• Software package upgrade
• Installing a new scanner

The new HASP utility upgrade will be delivered on a USB flash drive
(Disk-on-Key):

1. Connect the USB flash drive to either of the USB connection ports on
the system's service panel.

2. Turn on the system and access the HASP utility upgrade by pressing
the Cnfg. Upgrade button on the Utilities screen.

3. When the Welcome to feature Upgrade! pop-up window is displayed

(see Figure 7-1), follow the on-screen instructions until the upgrade is
complete.

4. When the upgrade is complete remove the USB flash drive from the
service panel.

Figure 7-1: System Hasp Plug Upgrade Pop-Up Window

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Maintenance AcuPulse

7.9. Moving and Transporting

the System

7.9.1. Moving the Most users of the AcuPulse laser system have more than one operating
Assembled System location. The system can easily be moved between them by rolling the
console on the base-mounted wheels using the top-mounted maneuvering
handle. The only disassembly required is disconnection of the footswitch
and power cable to ease maneuvering.

Rather than disconnecting them for each move, it may be easier to install a
power cable and footswitch in each location, leaving them in place.

7.9.2. Transporting the Prepare the system for transport as follows:

System
1. Unplug the system from the wall outlet.

2. Disconnect the power cable from the service panel.

3. Disconnect the footswitch from the service panel.

4. Fold and store the articulated arm in its storage compartment in the
system's rear panel.

5. Consult your Lumenis representative for shipping advice if desired.

Caution
Do not ship the system without the factory packaging materials.
Doing so may result in damage to the components during shipping
and void the warranty. Contact Lumenis if packaging materials or
repacking instructions are required.

Warning
The AcuPulse console weighs ~50 Kg (110 Lbs). Use proper lifting
techniques. Do not hurt yourself!

7-8 UM-1091300, Rev. F

8.

Chapter 8
Troubleshooting

8.1. Introduction The AcuPulse laser system is equipped with self-testing software that
continuously monitors system operation. If a system malfunction is
detected, an error message will appear on the display screen. Should a
malfunction occur, consult the troubleshooting guides in Section 8.4.

Do not attempt to open or disassemble the system's covers.

Only Lumenis-authorized technical personnel are qualified to service

the interior of the system.

8.2. Warranty The AcuPulse system is warranted for a period of one year.

The surgical and aesthetic accessories are warranted separately, each

according to the purchase agreement.

Caution
Improper use or adjustment of this system may invalidate the
service warranty agreement. Please contact your authorized
Lumenis distributor before attempting to troubleshoot this system
in any manner other than those specified in this manual.

8.3. Hazard The system generates high electrical voltage and laser radiation within the
Precautions main cabinet and optical bench. Only Lumenis-authorized technical
personnel are qualified to service the interior of the system.

8.4. Troubleshooting Table 8-1 provides a list of error messages that may appear on the LCD
Guides monitor. Some of these situations will automatically reset the system from
Ready mode to Standby mode, and some of them will include possible
remedies that may be attended to by clinic staff. In the latter case the
operator has the option of correcting the problem setting the system back
to Ready mode and continuing with normal operation.

Table 8-2 lists some possible system symptoms that indicate malfunctions
that do not appear on the display screen. If the corrective action listed in
the table does not solve the problem, contact Lumenis-authorized technical
personnel.

UM-1091300, Rev. F 8-1

 TM
Troubleshooting AcuPulse

If any error situation cannot be resolved, or if an error message returns

repeatedly, contact Lumenis Service.

The following troubleshooting tables do not attempt to list all possible

system failures. Any fault not listed should be referred to authorized
technical personnel.

Table 8-1: Error Messages Troubleshooting Guide

Message # Error Message Text

01 Open shutter error. Please restart system. If error persists, please call service.
02 Closed shutter error. Please restart system. If error persists, please call service.
04 Footswitch error. Please restart system. If error persists, please call service.
06 Footswitch is not connected. Please connect.
07 Footswitch engaged. Please disengage to proceed.
08 Smart Footswitch error – Please replace.
Cooling system flow switch error. Please restart system. If error persists, please call
12
service.
Cooling system pump current error. Please restart system. If error persists, please call
13
service.
15 Cooling system fan error. Please restart system. If error persists, please call service.
16 Cooling system overheating warning. Please allow 5 minutes for system cool down.
17 Cooling system overheating error. Please allow 20 minutes for system cool down.
18 System fan error. Please restart system. If error persists, please call service.
19 System overheating warning. Please allow 5 minutes for system cool down.
20 System overheating error. Please allow 20 minutes for system cool down.
23 Remote Interlock error. Please verify Treatment Room door is closed.
24 Laser stop button engaged. Please disengage to proceed.
26 HVPS Error. Please restart system. If error persists, please call service.
28 HVPS 110V status error. Please restart system. If error persists, please call service.
34 Invalid parameters error. Please restart system. If error persists, please call service.
GUI PC - DSP Communication error. Please restart system. If error persists, please call
35
service.
DSP - FPGA Communication error. Please restart system. If error persists, please call
36
service.
37 FPGA Status is 10xx. Please restart system. If error persists, please call service.

8-2 UM-1091300, Rev. F

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AcuPulse Troubleshooting

Table 8-1: Error Messages Troubleshooting Guide (continued)

Message # Error Message Text

Offset calibration (2.5V) error. Please restart system. If error persists, please call
39
service.
Offset calibration (0.5V) error. Please restart system. If error persists, please call
40
service.
41 LVPS 5V error. Please restart system. If error persists, please call service.
42 LVPS ±12V error. Please restart system. If error persists, please call service.
43 LVPS -12V error. Please restart system. If error persists, please call service.
44 LVPS +24V error. Please restart system. If error persists, please call service.
45 Power meter disk HW1 error. Please restart system. If error persists, please call service.
46 Power meter disk HW2 error. Please restart system. If error persists, please call service.
47 Power meter reading error. Please restart system. If error persists, please call service.
Power meter Low-Med (1W) error. Please restart system. If error persists, please call
48
service.
Power meter Med-High (5W) error. Please restart system. If error persists, please call
49
service.
50 Current monitoring error. Please restart system. If error persists, please call service.
51 Self test Interlock error. Please restart system. If error persists, please call service.
53 Current 1, 2 compare error. Please restart system. If error persists, please call service.
54 Temperature monitoring error.
55 On line monitor limit error.
56 Power convergence failure, max reachable power is # xxW
57 Self test power out error. Please restart system. If error persists, please call service.
Scanner synchronization error. Please restart system. If error persists, please call
65
service.
Scanner communication error. Please restart system. If error persists, please call
66
service.
68 Unsecured scanner disconnection error.
69 Scanner position error. Please restart system. If error persists, please call service.
70 Scanner is disconnected. Please connect.
71 Scanner board present error. Please restart system. If error persists, please call service.
74 Scanner position (X) error. Please restart system. If error persists, please call service. *
75 Scanner position (Y) error. Please restart system. If error persists, please call service. *
(*) Refer to Section 8.5

UM-1091300, Rev. F 8-3

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Troubleshooting AcuPulse

Table 8-1: Error Messages Troubleshooting Guide (continued)

Message # Error Message Text

76 Scanner PS ±15V error. Please restart system. If error persists, please call service.
78 Scanner ACUBLADE error. Please restart system. If error persists, please call service.
Scanner Servo (X/Y) calibration error. Please restart system. If error persists, please call
79
service.
82 Scanner ACUBLADE switch engaged. Please disengage to proceed.
83 SPI Bus error. Please restart system. If error persists, please call service.
84 CAN Bus error. Please restart system. If error persists, please call service.
300 HASP is not connected. Please restart system. If error persists, please call service.
301 HASP is not valid. Please restart system. If error persists, please call service.
302 Data base error. Please restart system. If error persists, please call service.
303 Data base update error. Please restart system. If error persists, please call service.
304 Software error. Please restart system. If error persists, please call service.

Table 8-2: Undisplayed System Malfunctions Troubleshooting Guide

Symptom Probable Cause Action

1. No AC power from wall outlet. 1. Check if AC power is available
System does not from wall outlet, and power cable
function when plugged is properly plugged into AC outlet.
in and turned on. 2. Tripped power circuit breaker 2. Reset power circuit breaker.
(clinic power supply).
1. Footswitch not connected 1. Check footswitch connection.
System will not switch properly.
to Ready mode. 2. Footswitch malfunction. 2. Contact Lumenis Service.
3. System malfunction. 3. Contact Lumenis Service.
1. System is not in Ready mode. 1. Set system to Ready mode.
Laser emission does 2. Damaged accessory. 2. Replace accessory.
not occur when
footswitch is pressed. 3. Footswitch malfunction. 3. Contact Lumenis Service.
4. System malfunction. 4. Contact Lumenis Service.
System not
Control panel’s touch-screen is out of
responding to touch- Contact Lumenis Service.
calibration.
screen commands
Laser emission
indicator does not Burnt LED. Contact Lumenis Service.
flash in Ready mode.

8-4 UM-1091300, Rev. F

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AcuPulse Troubleshooting

Table 8-2: Undisplayed System Malfunctions Troubleshooting Guide (continued)

Symptom Probable Cause Action

Inadvertent, light pressure on the
System changes from
footswitch (for more than 3 seconds)
Ready to Standby Press the Ready key and resume
may have activated 1 of the 2 internal
mode without input normal operation.
microswitches, causing the mode
command.
change for safety purposes.

8.5. Scanner Position A scan beam positioning error may occur with the 200mm, 260mm or
Error LAUP laser accessories when connected to the SurgiTouch scanner:

The error may occur on either of the X or Y planes because there are no
boundaries to the adjustments that can be made in the Beam Offset
correction screen with these accessories (see Section 5.11.1 in Chapter 5).

The error can happen as a result of the following scenario: you have set up
the scanner and 260mm handpiece for operation with a small shape size
(i.e., 4mm Ø), and you have moved the scan's location off-center using the
Beam Offset correction screen to a point near – but not outside – the
accessory tube's boundary. Next, you increase the shape to a larger size
(i.e., 10mm Ø); a portion of the scan's shape may now fall outside the
accessory tube's boundary (see Figure 8-1), causing the error. The system
will exhibit error message # 74 or # 75.

To correct the error: restart the AcuPulse system and select the
previously used accessory. Go into the Beam Offset screen (via the
Treatment screen) and press the Reset Offset button; this returns the scan
shape to the center of the accessory tube's work field.

Figure 8-1: Scanner Position Error (for illustration only)

UM-1091300, Rev. F 8-5

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Troubleshooting AcuPulse

The correct manner to adjust the Beam Offset is as follows:

1. Select the largest scan shape size available.

2. Make your beam offset adjustment.

3. Reduce the scan shape to the desired size.

8-6 UM-1091300, Rev. F

A.

Appendix A
Clinical Guide: Surgical Applications

A.1. Introduction This chapter is provided to aid professionals in the use of the AcuPulse
laser system for soft tissue applications in surgery. It adds to or reinforces
information presented in the operator's manual concerning instructions for
use, precautions and warnings necessary to reduce the risk of injury. All
operators must read the entire operator's manual before reviewing this
section and before operating the system.

A.2. Indications for Use The intended use of the AcuPulse system is for the vaporization, incision,
excision, ablation, or photocoagulation of soft tissue in the surgical
specialties of:
• Podiatry
• ENT
• Gynecology
• Laparoscopic Surgery including GYN Laparoscopy.
• Dental and Oral Surgery.
• Neurosurgery
• Orthopedics
• General Surgery and Podiatry.

The carbon dioxide laser wavelength is indicated for use in specific

surgical applications, as detailed in this chapter. Read and comprehend all
of the following general contraindications, warnings, precautions, and
recommendations, as well as indications and safety considerations for
appropriate specialties.

The physician is also advised to consult medical publications for clinical

parameters, techniques, and other current information on carbon dioxide
laser treatment in a particular specialty.

Warning
Lasers generate a highly concentrated beam of light that may
cause injury if improperly used. To protect the patient and the
operating room personnel, the entire laser and the appropriate
delivery system operator manuals, including all Safety and
Regulatory sections, should be carefully read and comprehended
before operation.

UM-1091300, Rev. F A-1

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Clinical Guide: Surgical Applications AcuPulse

Note
The use of a laser instrument for an application is at the
physician’s discretion except in cases where the application has
been specifically contraindicated.

A.3. Contraindications • Unless specifically indicated, do not use the CO2 laser on hard tissues,
such as bone or teeth.
• Unless otherwise specifically indicated, do not use the CO2 laser for
cutting or ablating dense, healthy bone or bone marrow (for example,
hard palate and mandible).
• Do not use the CO2 laser on vessels greater than 0.5 mm in diameter, as
hemostasis may not be effective
• Do not use the CO2 laser where a clinical procedure is precluded by
anesthesia requirements, site access, or other general operative
considerations.

A.4. General Laser • The surgeon must employ appropriate patient selection and pre- and
Recommendations post-operative management.

• Select the appropriate delivery device for the intended application after
consulting with surgical experts, reviewing the published literature, and
attending procedure-specific training programs.

• Ensuring the immediate availability of other surgical instruments for

coagulation (i.e., electrocautery, graspers, sutures, etc.) to control
hemostasis is strongly recommended.

• For char-free superficial ablation, pulsed laser modes or a scanner

accessory are recommended.

• As with conventional non-laser surgery, there is no guarantee that

treatment with the CO2 laser will entirely eliminate any disease entity.
Repeat treatment or alternative therapies subsequently may be required.

A.5. General Safety Warning

Considerations
• There is a risk of infection and scarring associated with any
surgical procedure. Therefore, appropriate pre-and post-surgical
care should always be practiced.
• Purge gases used with CO2 delivery devices and waveguides
may increase the risk of gas embolism where large, open
vessels are present. Monitor all patients for gas embolism,
which may occur even without the use of the laser.

A-2 UM-1091300, Rev. F

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AcuPulse Clinical Guide: Surgical Applications

A.6. Podiatry The AcuPulse laser is indicated for use in podiatry for the following
applications:

A.6.1. Podiatry • Laser ablation, vaporization and/or excision of soft tissue for the
Indications reduction, removal, and/or treatment of:
⇒ Verrucae vulgares/plantar (warts), including paronychial, periungal,
and subungual warts.
⇒ Fungal nail treatment.
⇒ Porokeratoma ablation.
⇒ Ingrown nail treatment.
⇒ Neuromas/fibromas, including Morton’s neuroma.
⇒ Debridement of ulcers.
⇒ Other soft tissue lesions.
• Laser ablation, vaporization, and/or excision for complete and partial
(nail) matrixectomy.

A.6.2. Safety General podiatry complications include:

Considerations and • Infection
Complications for
Podiatry • Ulceration of tissue.

Laser matrixectomy complications also include:

• Sterile inflammatory condition.

A.7. Otolaryngology The AcuPulse laser is indicated for laser incision, excision, ablation,
(ENT) and/or vaporization of soft tissue in otolaryngology for the treatment of:

A.7.1. ENT Indications • Choanal atresia.

• Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral
pharyngeal tissue.
• Nasal obstruction.
• Adult and juvenile papillomatosis polyps.
• Polypectomy of nose and nasal passages.
• Lymphangioma removal.
• Removal of vocal cord/fold nodules, polyps and cysts.

UM-1091300, Rev. F A-3

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Clinical Guide: Surgical Applications AcuPulse

• Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx,

pharynx and trachea, including the uvula, palatal, upper lateral
pharyngeal tissue, tongue and vocal cords.
• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral
structures and tissue.
• Zenker’s Diverticulum/ pharyngoesophageal diverticulum [endoscopic
laser-assisted esophagodiverticulostomy (ELAED)].
• Stenosis, including subglottic stenosis.
• Tonsillectomy (including tonsilar cryptolysis and neoplasma) and tonsil
ablation/tonsillotomy.
• Pulmonary bronchial and tracheal lesion removal.
• Benign and malignant nodules, tumors and fibromas (larynx, pharynx,
trachea, tracheobronchial/endobronchial).
• Benign and malignant lesions and fibromas (nose and nasal passages).
• Benign and malignant tumors and fibromas (oral).
• Acoustic neuroma in the ear.
• Stapedectomy, Stapedotomy.
• Superficial lesions of the ear, including chondrodermatitis nondularis
chronica helices/Winkler’s disease.
• Telangiectasia/hemangioma of larynx, pharynx, and trachea (includes
uvula, palatal, or upper lateral pharyngeal tissue).
• Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal
fold motion impairment), and cordal lesions of larynx, pharynx, and
trachea.
• Myringotomy/tympanostomy (tympanic membrane fenestration).
• Uvulopalatoplasty (LAUP, laser UPPP).
• Turbinectomy and turbinate reduction/ablation.
• Septal spur ablation/reduction and septoplasty.
• Partial glossectomy.
• Tumor resection of oral, subfacial and neck tissues.
• Rhinophyma
• Verrucae vulgares (warts).
• Gingivoplasty/gingivectomy.

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A.7.2. ENT • LAUP for palatal snoring is contraindicated without demonstrated

Contraindications obstruction by uvulopalatal tissue.

• LAUP for palatal snoring is contraindicated in pediatric patients (less

than 16 years) because the upper airway is not fully developed.

• When used as the only form of treatment for palatal snoring, LAUP may
not be effective in obese patients, patients with severe tonsillar hyper-
plasia, patients with macroglossia or patients with disproportionably
short necks.

A.7.3. Safety Warning

Considerations for
• To prevent airway fires and severe injury to the patient, protect
General ENT
endotracheal tubes from exposure to the CO2 wavelength, or
use CO2 laser- resistant endotracheal tubes.
• To prevent airway fires and severe injury to the patient, do not
direct the CO2 laser at any tracheal tube in any oxygen-enriched
environment, or any other environment that supports
combustion.
• To prevent airway fires and severe injury to the patient,
consideration of the type of anesthesia and ventilation are
important.
• To prevent severe injury to the patient, middle ear surgery
should be performed with appropriate parameters, considering
acoustic and thermal effects.
• Nasal and laryngeal probes (waveguides) produce a divergent
beam with a minimum spot size close to the tip of the
instrument.
• Avoid placing the tip of the nasal or laryngeal probe (waveguide)
in direct contact with tissue to prevent reduction of purge flow
and to reduce the risk of systemic gas embolism.
• Patients undergoing oropharyngeal or laryngeal surgery have to
be closely watched in the postoperative period for severe
edema which may cause life threatening airway obstruction and
for uncontrolled bleeding. The length of close observation
depends on the specific procedure and is up to the physician’s
consideration.

A.7.3.1. Safety Caution

Considerations for
LAUP The physician should take appropriate precautions when
evaluating and selecting patients presenting with chronic palatal
snoring and other significant symptoms of sleep apnea.

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A.7.3.2. Safety Warning

Considerations for
Myringotomy/ Clinical studies have shown that patency time is directly related to
Tympanostomy the diameter of the laser fenestration. The average diameter used
is 2.0mm; therefore, clinical judgment and caution should be used
when exceeding this diameter.
Uncooperative pediatric patients should be appropriately
restrained during office OtoLAM myringotomy/tympanostomy
procedures.

• It is recommended that a local or topical anesthesia be administered

prior to the OtoLAM myringotomy/tympanostomy procedure.

• Following laser-assisted myringotomy/tympanostomy, a pressure-

equalizing tube may be used in situations when long-term ventilation
has been determined to be necessary.

• Laser assisted myringotomy/tympanostomy should not be performed on

patients who do not have an accumulation of middle ear fluid present.

A.7.4. ENT Complications General ENT complications include:

and Expected • Unintended thermal injury from combustion of anesthesia or other
Sequelae volatile surgical preparation solutions.
• Excessive bleeding.
• Infection
• Edema
• Hearing loss.
Zenker’s Diverticulum:
• Transient soft tissue emphysema.
• Mediastinitis
Tonsil Ablation/Tonsillotomy:
• Transient dysphagia.
• Mucosa lesions.
Cordotomy:
• Formation of granuloma.
Turbinate Reduction/Ablation: transient nasal obstruction associated
with postoperative edema and limited nasal crusts.

LAUP complications include:

• Excessive bleeding.

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• Infection
• Edema
• Rhinophonia
• Nasopharyngeal stenosis.
• Velopharyngeal incompetence.

Myringotomy/tympanostomy complications include:

• Scarring
• Transient otorrea.
• Infection
• Recurrence of otitis media.

A.8. Gynecology and The AcuPulse laser is indicated for use in gynecology for the following
GYN Laparoscopy applications.

A.8.1. Gynecology and • Laser incision, excision, ablation and/or vaporization of soft tissue in
GYN Laparoscopy gynecology for the treatment of:
Indications ⇒ Conization of the cervix, including cervical intraepithelial neoplasia
(CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN).
⇒ Condyloma acuminata, including cervical, genital, vulvar, perineal,
and Bowenoid papulosa (BP) lesions.
⇒ Leukoplakia (vulvar dystrophies).
⇒ Incision and drainage (I&D) of Bartholin’s and nabothian cysts.
⇒ Herpes vaporization.
⇒ Urethral caruncle vaporization.
⇒ Cervical dysplasia.
⇒ Benign and malignant tumors.
⇒ Hemangiomas.

• Vaporization, incision, excision, ablation, or photocoagulation of soft

tissue in endoscopic and laparoscopic surgery, including gynecological
laparoscopy, for the treatment of:
⇒ Endometrial lesions, including ablation of endometriosis.
⇒ Excision/lysis of adhesions.
⇒ Salpingostomy
⇒ Oophorectomy

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⇒ Fimbrioplasty
⇒ Metroplasty
⇒ Microsurgery (tubal).
⇒ Uterine myomas and fibroids.
⇒ Ovarian fibromas and follicle cysts.
⇒ Uterosacral ligament ablation.
⇒ Hysterectomy

A.8.2. Gynecology and • Use of the CO2 laser is contraindicated for patients who are not
GYN Laparoscopy candidates for general surgery, where local or spinal epidural anesthesia
Contraindications is inappropriate.

• Use of the CO2 laser is contraindicated for laparoscopic applications

where laparoscopy is contraindicated.

A.8.3. Safety Warning

Considerations for
• When using a laser laparoscope or waveguide accessory,
Gynecology and
maintain an adequate flow of purge gas through the delivery
GYN Laparoscopy device. High purge flows require a specialized purge system or
recirculating insufflator/ smoke evacuator to prevent over-
pressurization and over-distention of the pneumoperitoneum
and resultant complications.
• Ensure that the laser laparoscope is properly aligned and a
clear, round aim beam is visible at all times.
• Laparoscopic waveguides produce a divergent beam with a
minimum spot size close to the tip of the instrument.
• Avoid placing the tip of the waveguide in direct contact with
tissue to prevent reduction of purge flow and to reduce the risk
of systemic gas embolism.
• In patients of fertility age, whenever surgery on the uterus is
planned either by laparoscopy or hysteroscopy, pregnancy has
to be excluded.

A.8.4. Gynecology and Gynecology and laparoscopic surgery complications include:

GYN Laparoscopy • Excessive bleeding.
Complications
• Infection
• Excessive thermal injury or vaporization of tissue.
• Gas embolism
• Subcutaneous emphysema.

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A.9. Neurosurgery The AcuPulse laser is indicated for laser incision, excision, ablation and/or
Indications vaporization of soft tissue in neurosurgery for the treatment of the
following indications (note Restriction below*):

• Cranial
⇒ Posterior fossa tumors.
⇒ Peripheral neurectomy.
⇒ Benign and malignant tumors and cysts, for example, gliomas,
meningiomas (including basal tumors), acoustic neuromas, lipomas,
and large tumors.
⇒ Arteriovenous malformation.
⇒ Pituitary gland tumors (transphenoidal approach).

• Spinal Cord
⇒ Incision/excision and vaporization of benign and malignant tumors
and cysts.
⇒ Intra- and extradural lesions.
⇒ Laminectomy/laminotomy/microdiscectomy.

Restriction
Neurological indications in contact with Central Nervous System are
only for USA.

A.9.1. Neurosurgery Do not use the laser on tumors that are inoperable or inaccessible with the
Contraindications laser beam.

A.9.2. Safety Warning

Considerations for
Using the laser to open the dura causes shrinkage that may make
Neurosurgery closure difficult or impossible.

A.9.3. Neurosurgery • Gas embolism

Complications
• There are no known complications specific to the use of the CO2 laser
in neurosurgery. However, the physician is advised to consult current
literature for any new information on potential neurosurgery
complications relating to CO2 laser treatment.

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A.10. Orthopedics The AcuPulse laser is indicated for incision, excision, and vaporization of
soft tissue in orthopedic surgery, including the following applications.

A.10.1. Orthopedics • Arthroscopy

Indications ⇒ Meniscectomy
⇒ Chondromalacia
⇒ Chondroplasty
⇒ Ligament release (lateral and other).
⇒ Excision of plica.
⇒ Partial synovectomy.
• General
⇒ Debridement of traumatic wounds.
⇒ Debridement of decubitus and diabetic ulcers.
⇒ Microsurgery
⇒ Artificial joint revision.
⇒ PMMA removal.

A.10.2. Safety Warning

Considerations for
Orthopedics • When performing arthroscopic surgery with waveguides where
purge gas is required, control the purge gas with a tourniquet to
prevent pressurization of an enclosed space (for example,
shoulder), which can result in gas embolism or systemic
subcutaneous emphysema.

• Residual carbon by-products of tissue vaporization are believed

to increase the risk of postoperative synovitis and other
complications. Mechanically scrape observed char from lased
tissue surfaces following use of the laser.

A.10.3. Orthopedics Orthopedics complications include:

Complications • Subcutaneous emphysema.
• Synovitis

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A.11. General and The AcuPulse laser is indicated for incision, excision, and vaporization of
Thoracic Surgery soft tissue in general and thoracic surgery, including endoscopic and open
procedures. Applications include the following.

A.11.1. General and • Debridement of decubitus ulcers, stasis, diabetic, and other ulcers.
Thoracic Surgery • Mastectomy
Indications
• Debridement of burns.
• Rectal and anal hemorrhoidectomy.
• Breast biopsy.
• Reduction mammoplasty.
• Cytoreduction for metastatic disease.
• Laparotomy and laparoscopic applications.
• Mediastinal and thoracic lesions and abnormalities.
• Skin tag vaporization.
• Atheroma
• Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the
lips.
• Pilonidal cyst removal and repair.
• Abscesses
• Other soft tissue applications.

A.11.2. Contraindications Use of the CO2 laser is contraindicated for laparoscopic procedures where
for General and laparoscopy is contraindicated.
Thoracic Surgery

A.11.3. Safety Refer to Gynecology in this chapter for safety considerations that are
Considerations for specific to laparoscopic procedures.
General and
Thoracic Surgery

A.11.4. General and General and thoracic surgery complications include:

Thoracic Surgery • Excessive bleeding.
Complications
• Infection
• Excessive thermal injury or vaporization of tissue.

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A.12. Dental and Oral The AcuPulse laser is indicated for incision, excision, and vaporization of
Surgery soft tissue in dentistry and oral surgery. Applications include the
following.

A.12.1. Dental and Oral • Gingivectomy/removal of hyperplasias.

Surgery Indications • Gingivoplasty
• Incisional and excisional biopsy.
• Treatment of ulcerous lesions, including aphthous ulcers.
• Incision of infection when used with antibiotic therapy.
• Frenectomy (frenum release).
• Excision and ablation of benign and malignant lesions.
• Homeostasis
• Operculectomy
• Crown lengthening.
• Removal of soft tissue, cysts, and tumors.
• Oral cavity tumors and hemangiomas.
• Abscesses
• Extraction site hemostasis.
• Salivary gland pathologies.
• Preprosthetic gum preparation.
• Leukoplakia
• Partial glossectomy.
• Periodontal gum resection.

A.12.2. Contraindications Use of the CO2 laser is contraindicated for hard tissue applications.
for Dental and Oral
Surgery

A.12.3. Safety Warning

Considerations for
While directing the laser beam near the tooth, shield the tooth from
Dental and Oral laser energy using either nonreflecting metal or an instrument
Surgery inserted between the tooth and gum, being careful to prevent laser
reflection.

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AcuPulse Clinical Guide: Surgical Applications

A.12.3.1. Complications of Dental ad oral surgery complications include:

Dental and Oral
Surgery • Laser damage to teeth through inappropriate use.
• Infection

A.13. References Albers AE et al “CO2 Laser Revision Stapedotomy” Laryngoscope 2013;

123 (6): 1519-26.
Bachy V, Matar N, Remacle M, Jamart Jacques J, Lawson G. "Long-Term
Functional Results After Endoscopic Cricopharyngeal Myology with CO2
Laser: a Retrospective Study of 32 Cases". Eur Arch Otorhinolaryngol
2013 270: 965-968
Baggish S. Michael (2003): "Colposcopy of the Cervix, Vagina and Vulva;
Section III". Treatment of Intraepithelial Neoplasia, Mosby.
Coleman JA Jr.: "Laser-Assisted Uvulopalatoplasty: Long-Term Results
with a Treatment of Snoring". Ear Nose Throat J. 1998 Jan;77(1):22-4,
26-9, 32-4.
Benninger Michael S.: “Microdissection or Microspot CO2 Laser for
Limited Vocal Fold Benign Lesions: A Prospective Randomized Trial”.
The Laryngoscope 110(2 Pt 2 Suppl 92):1-17 (2000).
Coromina et. al.: "Laser-Assisted Hypertrophic Tonsil Reduction in
Children Suffering from Obstructive Sleep Apnea Syndrome: 5-Year
Follow-Up Study". ASLMS 2006, lecture # 149).
Donnez, Jacques (2007): "Atlas of Operative Laparoscopy and
Hysteroscopy". Informa Healthcare, 3rd edition.
Fiorelli Alfonso et al; “The digital AcuBlade Laser System To Remove
Huge Vocal Fold Granulations Following Subglottic Airway Stent”
Interactive Cardiovascular and Thoracic Surgery 17 (3) 591-3, 2013.
Hinni, Michael L. Salassa, John R. Haughey, Bruce Steiner, Wolfgang et.
al.; "Transoral Laser Microsurgery for Advanced Laryngeal Cancer". Arch
Otolaryngol Head Neck Surg, Vol. 133 (No.12):1198-204 Dec 2007.
Holsinger, F. Christopher Weber, Randal; "Swing of the Surgical
Pendulum: A Return To Surgery For Treatment Of Head And Neck
Cancer In The 21st Century?" Int. J. Radiation Oncology Biol. Phys.,
Vol. 69, No. 2, Supplement, pp. S129 – S131, 2007.
Huttenbrink, Karl-Bernd: "Lasers in Otorhinolaryngology", Thieme Pubs.,
Chapter 2, S. Jovanovic: Lasers in Otology, p. 21-52.
Imamura S, Honda H.: "Carbon Dioxide Laser Vaporization of the Inferior
Turbinate for Allergic Rhinitis: Short Term Results". Ann Otol Rhinol
Laryngol. 2003 Dec;112(12):1043-9.
Jovanovic S.: "Technical and Clinical Aspects of “One-Shot” CO2 Laser
Stapedotomy"; Adv. Otorhinolaryngology, Basel, Karger, 2007, vol 65,
pp 255-266.

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Jovanovic S, Schönfeld U, Scherer H.: "CO2 Laser Stapedotomy with the

“One-Shot” Technique – Clinical Results". Otolaryngol Head Neck Surg.
2004 Nov;131(5):750-7.
Kamami YV, Pandraud L, Bougara A.: "Laser-Assisted Outpatient
Septoplasty Results in 703 Patients". Otolaryngol Head Neck Surg.
2000 Mar;122(3):445-9.
Lawson George “Endoscopic CO2 Laser-Assisted Surgery For
Cricopharyngeal Dysfunction” Eur Arch Otorhinolaryngol 2003, 260:475-
480.
Leufflen L et al: “Treatment of Vulvar Intraepithelial Neoplasia With CO2
Laser Vaporization and Excision Surgery” 2013 Journal of Lower Genital
Tract Disease 17 (4):446-51
Lesinski SG, Palmer A.: "CO2 Laser for Otosclerosis: Safe Energy
Parameters". Laryngoscope 1989 Jun;99(6 Pt 2 Suppl 46):9-12.
Li-jing Ma et al 2013 “Clinical Classification and Treatment of
Leukokeratosis of the Vocal Cords” Chinese Medical Journal 2013; 126
(18).
Lippert BM, Folz BJ, Rudert HH, Werner JA.: "Management of Zenker’s
Diverticulum and Postlaryngeal Peudodiverticulum with the CO2 Laser".
Otolaryngology Head and Neck Surgery 1999;121(6):809-14.
Lippert BM, Werner JA.: "Long-Term Results after Laser Turbinectomy".
Lasers Surg Med. 1998;22(2):126-34.
Maskell S, Eze N, Patel P, Hosni A.: "Laser Inferior Turbinectomy Under
Local Anaesthetic: A Well Tolerated Out-Patient Procedure". J Laryngol
Otol. 2007 Oct;121(10):957-61. Epub 2007 Feb 26.
Matar N, Amoussa K, Verduyckt I, Nollevaux MC, Jamart J, Lawson G,
Remacle M.: "CO2 Laser-Assisted Microsurgery for Intracordal Cysts:
Technique and Results of 49 Patients"; 2010, Eur Arch Otorhinolaryngol
2010 Dec;267(12):1905-9. Epub 2010 Jun 24.
Neruntarat C.: "Laser-Assisted Outpatient Septoplasty and Laser-assisted
Uvulopalatoplasty for Nasal Obstruction and Snoring". J Med Assoc Thai.
2005 Jun;88 Suppl 1:S66-72.
Nezhat et. al. (2000): "Operative Gynecologic Laparoscopy, Principles and
Techniques". 2/e, McGraw-Hill.
Preuss SF, Cramer K, Klussmann JP, Eckel HE, Guntinas-Lichius O.;
"Transoral Laser Surgery for Laryngeal Cancer: Outcome, Complications
and Prognostic Factors in 275 Patients". Eur J Surg Oncol 2009 Mar;
35(3):235-40. Epub 2008 Feb 20.
Remacle et. al.: "Accuracy of Histological Examination following
Endoscopic CO2 Laser-Assisted Laryngectomy". Otorhinolaryngologia
Nova 2002-03;12: 16-20).

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Remacle M, Betsch C, Lawson G, Jamart J, Eloy P.: "A New Technique

for Laser Assisted Uvulopalatoplasty: Decision-Tree Analysis and
Results", Laryngoscope 1999 May;109(5):763-8.
Remacle M, Hassan F, Cohen D, Lawson G, Delos M.: "New Computer-
Guided Scanner for Improving CO2 Laser-Assisted Microincision". Eur
Arch Otorhinolaryngology (2005) 262: 113-119.
Remacle M, Keghian J, Lawson G, Jamart J.: "Carbon-Dioxide Laser-
Assisted Tonsil Ablation for Adults with Chronic Tonsillitis: a 6-Month
Follow-Up Study". Eur Arch Otorhinolaryngology (2003) 260(8): 456-
459.
Roh,J. L. Kim, D. H. Park, C. I.; "Voice, Swallowing and Quality of Life
in Patients after Transoral Laser Surgery for Supraglottic Carcinoma".
Journal of Surgical Oncology, 2008 Sep 1;98(3):184-9.
Schrijvers ML, van Riel EL, Langendijk JA, Dikkers FG, Schuuring E,
van der Wal JE, van der Laan BF.; "Higher Laryngeal Preservation Rate
After CO2 Laser Surgery Compared With Radiotherapy in T1A Glottic
Laryngeal Carcinoma". Head Neck. 2009 Jun;31(6):759-64.
Sedlmaier B, Jivanjee A, Gutzler R, Huscher D, Jovanovic S.: "Ventilation
Time of the Middle Ear in Otitis Media with Effusion (OME) after CO2
Laser Myringotomy". Laryngoscope 2002 Apr;112(4):661-8.
Silverstein H, Jackson LE, Rosenberg SI, Conlon WS.: "Pediatric Laser-
Assisted Tympanostomy". Laryngoscope 2001 May;111(5):905-6.
Smith ME, Elstad M; "Mitomycin C and the endoscopic treatment of
laryngotracheal stenosis: are two applications better than one?"
Laryngoscope 2009 Feb;119(2):272-83.
Unkel C, Lehnerdt G, Schmitz KJ, Jahnke K.: "Laser-Tonsillotomy for
Treatment of Obstructive Tonsillar Hyperplasia in Early Childhood: A
Retrospective Review". Int. Journal of Pediatric Otorhinolaryngology
(2005) 69(12), 1615-1620.
van der Hem PS, Nauta JM, van der Wal JE, Roodenburg JL.: "The
Results of CO2 Laser Surgery in Patients with Oral Leukoplakia: A
25 Year Follow Up". Oral Oncology: (2005) 41(1), 31-37.
Waltman et. al.: "Endoscopic CO2 Laser Surgery for Zenker’s
Diverticulum – Application of Various Scanner Systems". Med. Laser
Appl. 17(3): 273-280 (2002).

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A-16 UM-1091300, Rev. F

B.

Appendix B
Clinical Guide: Aesthetic Applications

B.1. Introduction This chapter is provided to aid professionals in the use of the AcuPulse
laser system for soft tissue treatments in dermatology and plastic surgery
applications. It adds to, or reinforces, information presented in the
operator's manual concerning instructions for use, precautions and
warnings necessary to reduce the risk of injury. All operators must read the
entire operator's manual before reviewing this section and before operating
the system.

This clinical guide does not cover the use of the different handpieces.

The AcuPulse laser system is intended solely for use by physicians trained
in the operation of CO2 lasers.

Read and comprehend all of the following general contraindications,

warnings, precautions, and recommendations, as well as indications and
safety considerations for the appropriate specialties.

The physician is also advised to consult medical publications for clinical

parameters, techniques, and other current information on carbon dioxide
laser treatment in a particular specialty.

B.2. Indications for Use The intended use of the AcuPulse system is for the vaporization, incision,
excision, ablation, or coagulation of soft tissue in the aesthetic surgical
specialty. The carbon dioxide wavelength is indicated for use in specific
aesthetic applications, as detailed in this chapter.

Warning
Lasers generate a highly concentrated beam of light that may
cause injury if improperly used. To protect the patient, yourself and
the operating personnel, the entire laser and the appropriate
delivery system operator manuals, including all Safety and
Regulatory sections, should be carefully read and comprehended
before operation. Should you have any questions, consult with
your local Lumenis representative.

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B.3. General • Do not use the CO2 laser on hard tissues, such as bone or teeth.
Contraindications
• Do not use the CO2 laser for cutting or ablating dense, healthy bone or
bone marrow (for example, hard palate and mandible).

• Do not use the CO2 laser on vessels greater than 0.5 mm in diameter, as
hemostasis may not be effective.

• Do not use the CO2 laser where a clinical procedure is precluded by

anesthesia requirements, site access, or other general operative
considerations.

• Do not use the CO2 laser if the following conditions apply to the
patient:
⇒ Any concurrent cancer or history of skin cancer, except treatment of
specifically indicated skin cancer lesions (see Dermatology
indications for use below).
⇒ Immune-compromised conditions (i.e., uncontrolled diabetes).
⇒ Known anticoagulation treatment or thromboembolic condition.
⇒ Pregnancy or possibility of pregnancy, postpartum or nursing.
⇒ Use of photosensitive medication and/or herbal preparations for
which exposure to the 10.6 micron laser wavelength is
contraindicated.
⇒ Medical history of Koebnerizing isomorphic diseases (vitiligo,
psoriasis).

• Do not use the CO2 laser if the following conditions apply to the treated
area:
⇒ Recent exposure to sun in the 4-6 weeks pre-op plan or artificial
tanning in the past 2-3 weeks pre-op plan, remaining suntan,
sunburn or artificially toned skin.
⇒ Any concurrent skin condition such as active infections.
⇒ Active Herpes simplex (treatment can be given post preventive
treatment).

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B.4. Dermatology and Patients should not be considered for laser skin resurfacing procedures if
Plastic Surgery they:
Contraindications
• Have taken Isotretinoin within the past 12 months.

• Have a history of poor wound healing.

• Have a history of keloid formation, unless specifically indicated.

• Demonstrate excessive or unusually prolonged erythema or edema

(post- appropriate laser test patching) that may lead to hyper-
pigmentation or hypopigmentation.

B.5. General Laser • The physician must select appropriate patients and manage the pre- and
Recommendations post-operative care.

• Select the appropriate delivery device for the intended application after
consulting with medical experts, reviewing the published literature, and
attending procedure-specific training programs and preceptorships.

• As with conventional non-laser procedures, there is no guarantee that

treatment with the CO2 laser will entirely eliminate any lesion entity.
Repeat treatment or alternative therapies subsequently may be required.

B.6. General Laser Warning

Safety
Considerations • There is a risk of infection and scarring associated with any
CO2 procedure. Therefore, appropriate pre- and post-treatment
care should always be practiced.

• All personnel within the operating area of the laser must wear
suitable 10.600nm eye protection with a minimum optical
density (OD) of 5.0.

Caution
Laser test patching in an small inconspicuous area within the
treatment zone is recommended prior to treatment to validate
desired parameters and to avoid unexpected results.

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B.7. Dermatology/Plastic
Surgery (Aesthetic)

B.7.1. Dermatology/ The AcuPulse laser is indicated for use in dermatology and plastic surgery
Plastic Surgery for the following applications.
Indications
• Ablation, vaporization, excision, incision, and coagulation of soft tissue
in the performance of:
⇒ Laser skin resurfacing for the reduction, removal and /or treatment
of:
 Wrinkles, rhytids, and furrows (including fine lines and texture
irregularities).
 Keratoses, including actinic and seborrheic keratosis,
seborrhoecae vulgares, seborrheic wart and verruca seborrheica.
 Vermillionectomy of the lip.
 Cutaneous horns.
 Solar/actinic elastosis.
 Cheilitis, including actinic cheilitis.
 Lentigines, including lentigo maligna or Hutchinson’s
malignant freckle.
 Uneven pigmentation/dyschromia.
 Acne scars.
 Surgical scars.
 Keloids including acne keloidalis nuchae.
 Hemangiomas (including buccal, port wine and pyogenic
granulomas/granuloma pyogenicum/granuloma telangiectatica).
 Removal of small skin tumors, including periungual (Koenen)
and subungual fibromas.
 Superficial benign pigmented lesions.
 Adenosebaceous hypertrophy or sebaceous hyperplasia.
 Rhinophyma reduction.
 Cutaneous papilloma (skin tags).
 Milia
 Debridement of eczematous or infected skin.
 Basal and squamous cell carcinoma, including
keratoacanthomas, Bowen’s disease (Erythroplasia of Queyrat),
and Bowenoid Papulosis (BP) lesions.
 Nevi, including spider, epidermal and protruding.

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 Neurofibromas
 Laser de-epithelialization.
 Tricoepitheliomas
 Xanthelasma palpebrarum.
 Syringoma
 Laser dermabrasion.
 Laser burn debridement.
• Laser ablation, vaporization, and/or excision for complete and partial
nail matrixectomy.
• Vaporization/coagulation of:
⇒ Benign/malignant vascular/avascular skin lesions.
⇒ Moh’s surgery
⇒ Lipectomy
⇒ Verrucae and seborrhoecae vulgares, including paronychial,
periungal, and subungual warts.
• Laser incision and/or excision of soft tissue for the performance of
upper and lower eyelid blepharoplasty.
• Laser incision and/or excision of soft tissue for the creation of recipient
sites for hair transplantation.

B.7.2. Dermatology and Patients should not be considered for laser skin resurfacing procedures if
Plastic Surgery they:
Contraindications • Have taken Accutane® (Isotretinoin) within the past 6-12 months.
• Have a history of keloid formation.
• Have a history of poor wound healing.
• Demonstrate excessive or unusually prolonged erythema or edema
(post- appropriate laser test patching) that may lead to hyper-
pigmentation, or hypopigmentation.

B.7.3. Safety Caution

Considerations
In some treatments (for example tattoo removal), scar tissue
for Dermatology formation has been reported which may fade or become
and Plastic permanent. Therefore, use of the CO2 laser for cosmetic removal
Surgery of dermal skin lesions should be performed with caution since
there is a potential for scar formation.

UM-1091300, Rev. F B-5

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Clinical Guide: Aesthetic Applications AcuPulse

B.7.4. Complications, General dermatology and plastic surgery potential complications

Expected Side include:
Effects and • Scarring
Immediate
Responses • Ulceration
• Persistent edema and/or erythema.
• Infection

General dermatology and plastic surgery expected side effects include:

• Erythema that resolves over time.
• Swelling/edema that resolves over time.
In addition to these general complications and side effects, note the
following procedure-specific complications and responses.

Rhinophyma potential complications include:

• Transient pustule formation.
• Alar lift

Laser Matrixectomy potential complications include:

• Sterile inflammatory condition.

Blepharoplasty potential complications include:

• Ectropion
• Asymmetry of eyelids.
• Fold release (Asian eyelids).
• Wound dehiscence
• Postoperative bleeding
• Hematoma
• Keratoconjunctivitis sicca (dry eyes)
• Suture abscesses that resolve without treatment.
• Allergic reaction to surgical suture material.
• Conjunctivitis (usually transient).
• Ptosis (usually transient).

Blepharoplasty expected immediate responses include:

• Minimal bruising and swelling (as compared to cold steel).
• Minimal ecchymosis (as compared to cold steel).

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AcuPulse Clinical Guide: Aesthetic Applications

• Reduced intra-operative and/or post-operative pain (as compared to cold

steel)
• Slightly reduced healing time (as compared to cold steel)

Laser skin resurfacing potential complications include:

• Hypopigmentation
• Hyperpigmentation that resolves over time.
• Scarring that generally resolves over time with steroid treatment.
• Induration that generally resolves over time with steroid treatment.
• Formation of fibrotic tissue that generally resolves over time with
steroid treatment.
• Preauricular flap necrosis
• Postauricular skin slough/loss

Laser skin resurfacing possible short-term reactions include:

• Transient pain that is observed immediately post-operatively and
generally resolves quickly.
• Transient burning sensation that is observed immediately post-
operatively and generally resolves quickly.
• Itching that generally resolves within the first 2 weeks post-operatively.
• Sensation of tightness that resolves over time.

Laser skin resurfacing possible medium-term reactions include:

• Crusting that is observed immediately post-operatively through 2 weeks
postoperatively.
• Formation of milia that resolves over time.
• Contact irritant dermatitis to postoperative topical agents (primarily
antibiotics).
• Reactivation of herpes simplex.

Caution
The incidence and duration of post-operative hyperpigmentation
may be higher in patients with darker skin types (Fitzpatrick IV-VI,)
than in patients with lighter skin types (Fitzpatrick I-III). Selection of
treatment parameters should be considered carefully to reduce the
post-inflammatory response and care should be employed to
perform test patching before the procedure within sufficient period
of time as per skin type.

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Clinical Guide: Aesthetic Applications AcuPulse

B.8. Patient Care and The medical management of resurfacing is an evolving field. In addition to
Treatment studying current literature regarding the latest techniques, physicians are
Recommendations advised to obtain training by attending professional workshops and
preceptorships conducted by specialists in resurfacing.

The wavelength of this laser is absorbed by water. Combined to

appropriate treatment parameters, the laser beam provides an efficient
source of energy for the cutting and ablation of tissue with high water
content. This efficiency is coupled with a controlled residual heating that
may stimulate the wound healing process.

The effect of heat on the skin is both immediate and prolonged. Immediate
effect can be noted by erythema and edema due to the ablation,
coagulation and related skin inflammation process and collagen denaturing
that may also result in skin shrinkage. The long-term effect leads to
fibroblast activation and collagen remodeling. Therefore the accumulated
effect of treatment is expected over time and should be explained to the
patient.

The AcuPulse enables the use of four resurfacing techniques:

• Full resurfacing – the full surface of the treated area, epidermis to
dermis, are ablated to the desired depth according to the selected
parameters. Full resurfacing can only be achieved when using the Skin
Resurfacing Handpiece Set for SurgiTouch (Scanner Handpiece
125mm, 200mm or 260mm).
• Deep resurfacing in a fractional manner – 120 micron laser spots
ablate a fraction of the epidermis and dermis causing demarcated zones
of deep impact with surrounding healthy tissue, the relation of which is
dependent on the selected energy and coverage. Deep resurfacing in a
fractional manner can only be achieved when using the AcuScan120
microscanner.
• Superficial resurfacing in a fractional manner – 1.3mm laser spots
ablate a fraction of the epidermis and a minimal amount of dermis
causing demarcated zones of superficial impact with surrounding
healthy tissue, the relation of which is dependent on the selected energy
and coverage. Superficial resurfacing in a fractional manner can only
be achieved when using the AcuScan120 microscanner.
• Combo resurfacing in a fractional manner – using the same
AcuScan120 microscanner, Superficial and Deep fractional
resurfacing are made possible within the same scan combining the
above-described features. When using Combo mode, as compared to
Superficial or Deep alone, consider prolonged treatment downtime.

The Deep and Superficial resurfacing techniques may be used separately

or in conjunction for combined treatment, according to the desired effect.

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AcuPulse Clinical Guide: Aesthetic Applications

B.8.1. Pre-Operative Review and align with the patient the expectations for immediate and
Care long-term effect of treatment. Proper patient selection for fractional laser
resurfacing is essential.

• Smokers should be instructed to decrease smoking as much and as

long as possible before and after procedure to minimize the risk of
delayed or impaired wound healing.

• At the discretion of the physician, patients with Types III-VI skin may
be prescribed topical tyrosinase inhibitors, or an equivalent
depigmenting agent to prepare the skin.

• Patients with unrealistic expectations should be identified during the

consultation and discouraged.

• Once the appropriate laser candidate is selected, documentation in the

form of written, informed consent is essential as well as photo
documentation.

Along with your patient, decide on the prophylactic anti-viral, antibiotic

and antifungal drug that will suit the best for the planned treatment.

Ensure that the patient's skin area to be treated is thoroughly clean and dry
prior to treatment. If topical anesthesia is used prior to treatment, it is
important to ensure thorough removal, cleaning and drying of the
treatment area before treatment.

• Follow the guidelines of the manufacturing healthcare professional for

application dosage, occlusion and timing.

• Topical anesthetic:
⇒ Must be applied at the medical facility under the supervision of a
licensed practitioner.
⇒ Should not be applied to large areas because of the potential risk
for systemic absorption.

Prior to laser resurfacing, a test patch should be conducted with treatment

settings in a small inconspicuous area, but still in the requested anatomical
treatment zone.

• Especially people with darker skin types (Fitzpatrick IV to VI), with

sensitive skins or without pre-treatment regimen may develop delayed
healing, hyper- or hypopigmentation.

• Selection of treatment parameters should be considered carefully and

care should be employed to evaluate test patching following an
appropriate period of time.

UM-1091300, Rev. F B-9

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Clinical Guide: Aesthetic Applications AcuPulse

B.8.2. Post-Operative • Patients should be instructed to abstain from thermal impact or

Care mechanical injury to the treated area following treatment.

• Patients should apply cold gauzes soaked in sterile saline solution

immediately after treatment.

• Patients should be instructed that, as part of the wound healing

process, skin crusts (eschar) will appear in the treated area and should
be left to shed of naturally. Do not debride (wipe off eschar) and do
not use a wound dressing as these may prolong healing time. The
denatured eschar will serve as a completely bio-compatible wound
dressing.

• Patients should maintain an occlusion barrier coating of bland

petroleum-based ointment or an equivalent occlusive ointment or
dressing, to prevent direct contact between the treated tissue and the
air during the healing process.

Note
The use of a barrier coating improves patient comfort, prevents
inflammation and reduces the sensation of pain and burning by
preventing air from contacting the treated region. The occlusive
dressing should be maintained or changed as needed until crusting
of the serous exudates is diminished.

• The patient should gently wash area with tepid water and mild cleanser
3-4 times a day, starting morning after treatment; immediately re-
apply occlusive ointment for a “glossing” effect.

• Avoid environmental irritants during healing process (i.e. dust, dirt,

perfume, sun).

• Patients should discontinue use of occlusive ointment and begin the

use of a facial moisturizer following wound closure and as per the
physician's discretion.

• The patient should resume daily use of sunscreen and topical tretinoin
following wound healing. At the discretion of the physician, patients
with Types III-VI skin may also resume use of topical tyrosinase
inhibitors, or an equivalent depigmenting agent (twice daily).

• Recommend that the patient avoid direct sunlight as part of the early
post-op instructions and then uses sun protector with high SPF (50+)
for at least 2 months after the treatment.

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AcuPulse Clinical Guide: Aesthetic Applications

B.9. Adverse Event Note

Management
If there is any adverse effect, treatment should be discontinued until
the treatment site has completely healed and the reason for the
adverse reaction is understood.

Laser skin resurfacing procedures have a minimal risk of adverse effects.

In the rare cases where adverse effects do occur, the most common are:

• Pruritus
⇒ Mild-to-moderate pruritus may occur during re-epithelialization
and may last for about 10 days.
⇒ Recent evidence suggests that this symptom relates to a yeast
infection or colonization in healing skin.
⇒ Treatments with emollients or topical steroids are the common
practice.

• Acne Flares and Milia

⇒ Swelling of the skin from the procedure, and skin debris – dead
skin cells – left behind may block pores. Blockage of the pores can
lead to build up of skin oils.
⇒ May last for approximately 12 days.
⇒ Limitation of the occlusiveness of healing ointments mostly
minimizes the risk.

• Post-Inflammatory Hyperpigmentation
⇒ PIH may become apparent between 2 weeks and 2 months after
post-operative erythema has resolved.
⇒ As soon as re-epithelialization is complete and erythema resolved,
a topical bleaching regimen may be prescribed.
⇒ Post-inflammatory hyperpigmentation is usually reversible over
time. It can take between 3-6 months and can be easily concealed
in the meantime with makeup.

• Hypopigmentation
⇒ May be clinically apparent 1 to 6 months after treatment. It is
more commonly observed on darker skin types and often related to
the depth of resurfacing or to the usage of inappropriate laser
parameters.
⇒ Sun exposure must be avoided (imperative); it may actually
worsen the change of pigmentation and its duration.
⇒ May last 6-12 months but could also remain permanent.

UM-1091300, Rev. F B-11

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Clinical Guide: Aesthetic Applications AcuPulse

• Scarring
⇒ Most often result from poor technique, poor post-operative care or
post-operative infection.
⇒ May be treated with injections of intralesional corticosteroids.

B.10. References Adrian RM. “Pulsed carbon dioxide and erbium-YAG laser resurfacing: a
comparative clinical and histologic study”. J Cutan Laser Ther 1999;
1(1):29-35.
Chernoff W G. “Histological Perspective of Laser Resurfacing.” Operative
Techniques in Otolaryngology—Head and Neck Surgery 1997; 8(1):2–8.
David L; Abergel R. “CO2 Laser Blepharoplasty.” Cosmetic Surgery of the
Skin: Principles and Techniques, B.C. Decker, Philadelphia, PA, 1991,
Chapter 15:295–300.
Glassberg E; Babapour R; Lask G. “Current Trends in Laser Blepharo-
plasty.” Dermatol Surg 1995; 21(12):1060–1063.
Gold MH, Biron JA. “Combined superficial and deep fractional skin
treatment for photodamaged skin – a prospective clinical trial”. Journal of
cosmetic and laser therapy, 2012; 14:124-132.
Goldman MP. “Postoperative Care of the Laser Resurfacing Patient.”
Operative Techniques in Otolaryngology—Head and Neck Surgery
1997;8(1):35–36.
Hedelund L., Bjerring P.; Egekvist H., Haedersdal M.. "Ablative versus
Non-Ablative Treatment of Perioral Rhytids. A Randomized Controlled
Trial with Long-Term Blinded Clinical Evaluations and Non-Invasive
Measurements" Lasers in Surgery and Medicine, 2006, Volume 38,
Issue 2, Pages 129-136.
Kilmer S; Linsmeier M D. “Preoperative Preparation of the Laser
Resurfacing Patient.” Operative Techniques in Otolaryngology— Head
and Neck Surgery 1997; 8(1):31–34.
Kilmer S L., Chotzen V A., Silva S K., McClaren M L.. "Safe and
Effective Carbon Dioxide Laser Skin Resurfacing of the Neck", Lasers in
Surgery and Medicine, 2006, Volume 38, Issue 7, Pages 653-657.
Morrow DM; Morrow LB. “CO2 Blepharoplasty: A Comparison with
Cold- Steel Surgery.” J Dermatol Surg Oncol 1992; 18(4):307–313.
Rosenberg G J. “Full Face and Neck Laser Skin Resurfacing.” Plastic and
Reconstructive Surgery 1997; 100(7):1846–54.
Ross V E; Naseef G S; McKinlay J R; Barnette D J; Skrobal M; Grevelink
J; Annserson R R. “Comparison of Carbon Dioxide Laser, Erbium:YAG
Laser, Dermabrasion and Dermatome.” Journal of the American Academy
of Dermatology 2000; 42(1 Pt. 1):92–105.

B-12 UM-1091300, Rev. F

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Rostan F., Fitzpatrick Richard E., Goldman Mitchell P.. "Laser

Resurfacing With a Dual-Mode, Long-Pulse Erbium:YAG Laser
Compared to the 950-µs Pulsed CO2 Laser". Lasers Surg Med 2001; 29(2):
136-141.
Saluja R, Khoury J, Detwiler S, Mitch Goldman. "Histologic and Clinical
Response to Varying Density Settings with a Fractionally Scanned Carbon
Dioxide Laser", Journal of Drugs in Dermatology, January 2009, Vol 8
(1):17-20.
Tan K L, Kurniawati C, Gold M. "Low Risk of Postinflammatory
Hyperpigmentation in Skin Types 4 and 5 after Treatment with Fractional
CO2 Laser Device", Journal of Drugs in Dermatology, August 2008, Vol
7(8):774-7.
Waibel J, Beer K. "Ablative Fractional Laser Resurfacing for the
Treatment of a Third Degree Burn", Journal of Drugs in Dermatology,
March 2009, Vol 8(3):294-7.

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B-14 UM-1091300, Rev. F

C.

Appendix C
EMC Guidance and Manufacturer's
Declaration

C.1. Electromagnetic
Emissions

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

AcuPulse is intended for use in the electromagnetic environment specified below. The customer or the user
of AcuPulse should ensure that it is used in such an environment.
Electromagnetic Environment –
Emissions test Compliance
guidance
AcuPulse uses RF energy only for
its internal function; therefore, its
RF emissions are very low and
RF emissions CISPR 11 Group 1
are not likely to cause any
interference in nearby electronic
equipment.
RF emissions CISPR 11 Class A AcuPulse is suitable for use in all
establishments other than
Harmonic emissions domestic and those directly
Class A
IEC 61000-3-2
connected to the public low-
voltage power supply network that
Voltage Fluctuations/ flicker supplies buildings used for
Complies
emissions IEC61000-3-3
domestic purposes.

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EMC Guidance and Manufacturer's Declaration AcuPulse

C.2. Electromagnetic
Immunity

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

AcuPulse is intended for use in the electromagnetic environment specified below. The customer or the user
of AcuPulse should ensure that it is used in such an environment.
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment - Guidance
Electrostatic Discharge ±6kV contact ±2,4,6kV contact Floors should be wood,
(ESD) ±8kV air ±2,4,8kV air concrete, or ceramic tile.
IEC61000-4-2 If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast ±2kV for power supply ±2kV line to ground Mains power quality
transient/burst lines ±1kV line to line should be that of a
IEC61000-4-4 ±1kV for input/output typical commercial or
lines hospital environment.
Surge ±1kV Differential mode ±0.5, 1kV Differential Mains power quality
mode should be that of a
IEC61000-4-5 ±2kV Common mode ±0.5, 1, 2kV Common typical commercial or
mode hospital environment.
Voltage dips, short <5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) Mains power quality
interruptions and voltage for 0.5 cycle for 0.5 cycle should be that of a
variations on power 40% Ut (60% dip in Ut) 40% Ut (60% dip in Ut) typical commercial or
supply input lines for 5 cycles for 5 cycles hospital environment. If
IEC61000-4-11 the user of AcuPulse
70% Ut (30% dip in Ut) 70% Ut (30% dip in Ut)
requires continued
for 25 cycles for 25 cycles
operation during power
<5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) mains interruptions, it is
for 5 sec. for 5 sec. recommended that
AcuPulse be powered
from an uninterrupted
power supply or a
battery.
Power frequency 3 A/m 3 A/m Power-frequency
(50/60Hz) magnetic field magnetic fields should
IEC 61000-4-8 be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: Ut is the AC mains voltage prior to application of the test level.

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AcuPulse EMC Guidance and Manufacturer's Declaration

Guidance and Manufacturer's Declaration - Electromagnetic Immunity (continued)

AcuPulse is intended for use in the electromagnetic environment specified below. The customer or the user
of AcuPulse should ensure that it is used in such an environment.
Portable and mobile RF communications
equipment should be used no closer to any
part of the AcuPulse system, including its
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended Separation Distance:
Conducted RF 3 Vrms 3V d = 1.17√P
IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 Vm d = 1.17√P 80 MHz to 800 MHz
IEC 61000-4-3 80MHz to 2.5 d = 2.33√P 800 MHz to 2.5 GHz
GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
(a), should be less than the compliance level in
each frequency range (b).
Interference may occur in the vicinity of
equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
AcuPulse is used exceeds the applicable RF compliance level above, the AcuPulse should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the AcuPulse.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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EMC Guidance and Manufacturer's Declaration AcuPulse

C.3. Recommended Separation Distances

Recommended separation distances between portable and mobile RF communications equipment

and the AcuPulse
The AcuPulse is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the AcuPulse can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the AcuPulse as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum output Separation distance (m) according to frequency of transmitter

power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d = 1.17√P d = 1.17√P d = 2.33√P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

C-4 UM-1091300, Rev. F