Operators Manual
116 Pages
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7 0 WAT T a n d 4 0 WAT T MO D E L S O P E R A T O R ’ S
M A N U A L
Copyright © 2010, Alma Lasers, Ltd. No part of this manual may be reproduced or copied in any form by any means - graphic, electronic or mechanical, including photocopying, typing, or information retrieval systems - without written permission of Alma Lasers. System specifications and the information contained in this document are subject to change without notice. All rights reserved. Alma Lasers™ Ltd., its logo, Accent™, Accent™XL, Aria®, Aria SHR™, Harmony®, Harmony®XL, HarmonyPixel™, Pixel®, Sonata®, Soprano®, Soprano®XL, Tenor™, Pixel® CO2, Hair Removal in Motion™, DualChill™, BlendMode™, Wellbeing Through Technology® and The Magic of Light® are the trademarks of Alma Lasers, Ltd. Alma Lasers Ltd. 14 Halamish St., P.O.B. 3021 Caesarea Industrial Park Caesarea, Israel 38900 Tel: +972-4-627-5357 Fax: +972-4-627-5368 Email: [email protected] Alma Lasers, Inc. 485 Half Day Road Suite # 100 Buffalo Grove, IL 60089 Tel: 1-866-414-2562 Fax: 1-954-229-8310 Email: [email protected] Website: www.almalasers.com Authorized Representative in the EC: A B C Lasers 292 Hills Road, Great Shelford Cambridge, CB2 0QG, UK Tel: +44 (0) 845 170 7788 Fax: +44 (0) 1223 846471
Catalog No. OMCO10010801 Revision 2, February 2010
Scope of Manual
Scope of This Manual This operator's manual incorporates the following chapters: Chapter 1
System Overview
Contains a general introduction to the Pixel CO2 system.
Chapter 2
Safety
Contains explanations and directions concerning safety measures for operating the system, international standard compliance, classifications and regulatory labels.
Chapter 3
Installation
Lists electrical, space and environmental requirements for installation of the system.
Chapter 4
System Description
Contains a detailed overview of the Pixel CO2 system and its various sub-systems, accessories and technical specifications.
Chapter 5
Controls and Indicators
Describes the control and service panels, footswitch and various connections to the system, and functional indicators.
Chapter 6
System Operating Instructions
Explains how to operate the system, offering basic information and explanations of the operating screens.
Chapter 7
Maintenance
Provides a detailed review of how to maintain the system.
Chapter 8
Troubleshooting
Lists the system error messages that might appear during operation, their probable causes and what corrective actions to perform.
Appendix A
Clinical Guide
Clinical Guide for pivotal clinical information, and pre- / intra- and post-procedure activities.
Appendix B
Electromagnetic Compatibility
Conditions under which the Pixel CO2 system should be operated
Pixel® CO2 Operator's Manual
i
Table of Contents
Table of Contents CHAPTER 1
System Overview 1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 1.7. 1.8.
CHAPTER 2
Safety 2.1. 2.2.
2.3. 2.4.
2.5.
2.6.
2.7. 2.8. ii
Page
Introduction ... 1-2 Treatment Parameters ... 1-2 Use of this Manual... 1-2 Physician Responsibility ... 1-3 Maintenance ... 1-3 Modification of the System ... 1-4 Resale Inspection... 1-4 Abbreviations and Acronyms ... 1-4
Page Introduction ... 2-2 System Safety Measures... 2-2 2.2.1. Electrical Safety... 2-2 2.2.2. Laser Safety ... 2-3 The Treatment Room... 2-4 General Precautions and Cautions... 2-5 2.4.1. Precautions... 2-5 2.4.2. Cautions... 2-5 Warnings Related to Laser Emission... 2-6 2.5.1. Burn Hazards... 2-6 2.5.2. Direct and Reflected Eye Exposure Hazards... 2-6 2.5.3. Explosion and Fire Hazards... 2-6 2.5.4. High Voltage Hazards ... 2-7 2.5.5. Grounding the System... 2-7 System Safety Features... 2-7 2.6.1. Emergency Shut-Off Knob ... 2-7 2.6.2. Main Circuit Breaker... 2-7 2.6.3. Laser Emission Indicators ... 2-8 2.6.4. Laser Safety Shutter... 2-8 2.6.5. Remote Interlock Connector ... 2-8 Equipment Classification and Compliance... 2-9 Device Labels ... 2-10 Pixel® CO2 Operator's Manual
Scope of Manual
CHAPTER 3
2.8.1. 2.8.2.
System Labels ... 2-10 Packaging Label... 2-14
Installation
Page
3.1. 3.2. 3.3.
3.4. 3.5.
3.6. 3.7. 3.8. 3.9.
CHAPTER 4
Introduction ... 3-2 Equipment List ... 3-2 Facility Requirements ... 3-3 3.3.1. Electrical Requirements ... 3-3 3.3.2. Environmental Requirements ... 3-3 3.3.3. Space and Positioning ... 3-4 Unpack the System... 3-5 Delivery System Preparation... 3-7 3.5.1. Articulated Arm Release and Configuration ... 3-7 3.5.2. Handpiece Connection ... 3-8 Remote Interlock Connection... 3-9 Connecting the Footswitch... 3-9 Coolant Reservoir... 3-10 Moving the System... 3-10
System Description 4.1. 4.2.
4.3. 4.4.
Page
Introduction ... 4-2 System Components and Controls ... 4-2 4.2.1. Main Console ... 4-4 4.2.2. Optical Bench Assembly ... 4-5 4.2.3. Articulated Arm Beam Delivery System ... 4-5 4.2.4. Laser Handpieces ... 4-5 4.2.4.1. Pixel Handpieces 4-5 4.2.4.2. Surgical Focusing Handpieces 4-5 4.2.5. The Control Panel ... 4-6 4.2.6. Laser Cooling System ... 4-6 4.2.7. Purge-Air System... 4-6 4.2.8. Service Panel ... 4-7 4.2.9. Footswitch ... 4-7 System Modes of Operation ... 4-8 4.3.1. Basic Concepts and Definitions... 4-8 System Specifications ... 4-9
Pixel® CO2 Operator's Manual
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Table of Contents
4.4.1.
4.4.2.
4.4.3. 4.4.4. 4.4.5. 4.4.6.
CHAPTER 5
Controls and Indicators 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7. 5.8.
5.9.
CHAPTER 6
6.3.
6.4.
6.5. 6.6.
Page
Introduction ... 5-2 Keyswitch ... 5-2 Emergency Shut-off Knob... 5-2 Laser Emission Indicator ... 5-2 Laser Safety Shutter ... 5-3 Audio Indicator... 5-4 LCD Touch-Screen Control Panel... 5-5 Service Panel ... 5-6 5.8.1. Main Circuit Breaker... 5-6 5.8.2. Main Power Switch... 5-6 Footswitch ... 5-7
Operating Instructions 6.1. 6.2.
iv
Output ... 4-9 4.4.1.1. CW (Continuous Wave) Mode 4-9 4.4.1.2. Super Pulse Mode 4-9 Delivery System ... 4-10 4.4.2.1. Pixel Handpieces 4-10 4.4.2.2. Surgical Focusing Handpieces 4-11 Operation and Control ... 4-11 Electrical Requirements... 4-12 Physical ... 4-12 Classifications ... 4-12
Page
Introduction ... 6-2 Turning on the Pixel CO2 System ... 6-2 6.2.1. Error Detection... 6-4 Operating the Pixel CO2 System ... 6-5 6.3.1. Operating in Pixel Mode ... 6-5 6.3.2. Operating in Surgical Mode ... 6-7 Operating Parameters ... 6-8 6.4.1. Saving New Operating Parameters ... 6-8 6.4.2. Reset Default Parameters ... 6-9 Pause in Operation... 6-9 Aiming Beam Intensity Adjustment ... 6-10
Pixel® CO2 Operator's Manual
Scope of Manual
6.7.
CHAPTER 7
Maintenance 7.1. 7.2. 7.3. 7.4.
7.5.
CHAPTER 8
System Shut-Down... 6-12
Introduction ... 7-2 Periodic Service... 7-2 Service Information... 7-3 Routine Maintenance... 7-3 7.4.1. Cleaning and Disinfecting the System ... 7-4 7.4.1.1. Disassembling the Pixel Handpiece 7-4 7.4.1.2. Disassembling the Regular Focusing Handpieces 7-5 7.4.1.3. Handpiece Spacer Tips – Cleaning Instructions 7-6 7.4.1.4. Handpiece Spacer Tips – Sterilization Instructions 7-6 7.4.2. Laser Beam Alignment Check... 7-7 7.4.3. Cooling System Refilling ... 7-8 Periodic Maintenance Schedule ... 7-10
Troubleshooting 8.1. 8.2.
Page
Introduction ... 8-2 Troubleshooting Guides ... 8-2
APPENDIX A Clinical Guide A.1. A.2. A.3.
Page
Page
Introduction ... A-2 Training Requirements ... A-2 Indications for Use ... A-3 A.3.1. Dermatology & Plastic Surgery ...A-3 A.3.2. Podiatry ...A-5 A.3.3. Otolaryngology (ENT)...A-5 A.3.4. Gynecology (GYN)...A-6 A.3.5. Neurosurgery...A-7 A.3.5.1. Cranial A-7 A.3.6. Orthopedics ...A-8 A.3.6.1. Arthroscopy A-8 A.3.6.2. General A-8 A.3.7. General/Thoracic Surgery...A-8 A.3.8. Genitourinary ...A-9
Pixel® CO2 Operator's Manual
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Table of Contents
A.4. A.5. A.6.
A.7. A.8. A.9. A.10. A.11.
A.12.
A.13.
A.14.
APPENDIX B
Electromagnetic Compatibility B.1. B.2. B.3. B.4.
vi
Contraindications... A-9 Adverse Effects of Treatment... A-10 Pre-Treatment Information ... A-10 A.6.1. General ...A-10 A.6.2. Counseling ...A-11 A.6.3. Patient Selection ...A-11 A.6.4. Pre-Treatment Recommendations...A-11 A.6.5. Anesthesia Considerations...A-12 Required Accessories and Equipment ... A-12 Photography... A-12 Specific Precautions, Recommendations and Warnings ... A-13 Fire Precautions ... A-13 Treatment... A-14 A.11.1. Handpiece Technique ...A-14 A.11.2. Skin Test...A-14 A.11.3. Treatment Protocol...A-15 Suggested Setup Parameters... A-16 A.12.1. Suggested Setup Parameters for the 7 x 7 Pixel Handpiece...A-16 A.12.2. Suggested Setup Parameters for the 9 x 9 Pixel Handpiece...A-17 Post-Treatment and Follow-Up Care... A-18 A.13.1. Open Wound Care ...A-18 A.13.2. Closed Wound Care...A-18 Sample Forms... A-20 A.14.1. Sample Medical History Form...A-20 A.14.2. Sample Informed Consent Form – Pixel CO2 ...A-22
Page
Cable Lengths and Replacements... B-2 Electromagnetic Emission – Guidance & Manufacturer Declaration ... B-2 Electromagnetic Immunity – Guidance & Manufacturer Declaration... B-3 Recommended Separation Distances between Portable and Mobile RF Communication Equipment and the Pixel CO2 ... B-5
Pixel® CO2 Operator's Manual
Scope of Manual
List of Figures Figure
Description
Page
Figure 1-1: Pixel CO2 Application ... 1-2 Figure 2-1: Treatment Room Warning Sign ... 2-4 Figure 2-2: Identification Labels ... 2-11 Figure 2-3: Laser Danger Labels ... 2-12 Figure 2-4: Laser Class 4 Labels ... 2-12 Figure 2-5: Electrical Requirement and Hazard Labels... 2-13 Figure 2-6: Coolant Full Notification Tag... 2-13 Figure 2-7: Grounded Cable Warning Label ... 2-13 Figure 2-8: Shipping Crate Label ... 2-14 Figure 3-1: System Dimensions... 3-4 Figure 3-2: Pixel CO2 Shipping Crate ... 3-5 Figure 3-3: Unpacking the System (1)... 3-5 Figure 3-4: Unpacking the System (2)... 3-6 Figure 3-5: Releasing the Articulated Arm... 3-7 Figure 3-6: Connecting the Handpiece ... 3-8 Figure 3-7: Remote Interlock and Footswitch Connections ... 3-9 Figure 4-1: Major System Components... 4-3 Figure 4-2: Block Diagram... 4-4 Figure 4-3: Service Panel ... 4-7 Figure 4-4: Footswitch Pedal... 4-7 Figure 4-5: Basic Concepts of General Periodic Function ... 4-8 Figure 5-1: Laser Safety Shutter and Switch... 5-3 Figure 5-2: System Controls... 5-4 Figure 5-3: LCD Control Panel (in CW Mode)... 5-5 Figure 5-4: Service Panel ... 5-6 Figure 5-5: Footswitch... 5-7 Figure 6-1: Start Screen ... 6-3 Figure 6-2: Select Handpiece Screen... 6-4 Figure 6-3: Pixel Mode Operation Screen ... 6-5 Figure 6-4: Surgical Mode Operation Screen ... 6-7 Figure 6-5: Password Screen ... 6-10 Figure 6-6: Virtual Keypad... 6-11 Figure 7-1: Access to the Pixel Handpiece's Optical Lens ... 7-4 Pixel® CO2 Operator's Manual
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Table of Contents
Figure 7-2: Regular Focusing Handpiece - Disassembly... 7-5 Figure 7-3: Laser Beam Alignment Check – Regular Focusing Handpiece ... 7-7 Figure 7-4: Water Filling Kit ... 7-8 Figure 7-5: Coolant Fill and Vent Ports... 7-9 Figure A-1: Pixel CO2 (7 x 7 Pixels) Pattern and Skin Reaction... A-2 Figure A-2: Pixel CO2 Handpiece... A-14
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Pixel® CO2 Operator's Manual
CHAPTER 1 System Overview Chapter Contents: Section
Title
1.1.
Introduction ... 1-2
1.2.
Treatment Parameters ... 1-2
1.3.
Use of this Manual... 1-2
1.4.
Physician Responsibility... 1-3
1.5.
Maintenance... 1-3
1.6.
Modification of the System ... 1-4
1.7.
Resale Inspection ... 1-4
1.8.
Abbreviations and Acronyms ... 1-4
Pixel® CO2 Operator's Manual
Page
1-1
System Overview
1.1.
Introduction The Pixel CO2 system uses a fractionated technology for ablative and thermal injury to the epidermis and dermis. The Pixel CO2 delivers fractionated laser energy through a special lens that divides the energy to 7 x 7 (49) or 9 x 9 (81) tiny spots or "pixels" (see Figure 1-1). These pixels (that create the thermal damage) are spaced so that the tissue between each is left unaffected – which results in a faster healing process. The tiny laser rays cause thermal damage that penetrates the dermis to stimulate the growth of new collagen. Please refer to Appendix A of this manual for a complete list of the Pixel CO2 system's clinical indications.
Figure 1-1: Pixel CO2 Application
1.2.
Treatment Parameters Before treatment initiation, the operator selects the appropriate treatment operating parameters based on patient’s skin type and condition, and the requested laser power to which the treated area is exposed. Each time the operator presses the footswitch, the Pixel CO2 system emits a laser pulse.
1.3.
Use of this Manual The Pixel CO2 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 Pixel CO2 system.
1-2
Pixel® CO2 Operator's Manual
System Overview
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 system operation. If any part of this manual is not clear, please contact your Alma Lasers representative for clarification. Warning Use of controls or adjustments, or performance of procedures other than those specified herein may put the operator and/or the patient at risk. Therefore, before attempting to use or operate the system, personnel operating the Pixel CO2 system should read this manual and become thoroughly familiar with all its safety requirements and operating procedures. The information provided in this manual is not intended to replace the professional training on the clinical use of the system. Please contact your Alma Lasers representative for current information on available training. For clinical information, refer to the Clinical Guide appendices that include set up guidelines for each application. This manual should always accompany the system and all operating personnel must know its location. Additional copies of this manual are available from Alma Lasers or your local Alma Lasers representative. For further information about Alma Lasers, visit the company website at: http://www.almalasers.com.
1.4.
Physician Responsibility Regulatory statutes in most countries restrict prescription of medical devices for sale by or on the order of a physician, or properly licensed practitioner. The properly licensed practitioner will be responsible for the use and operation of the device and for all operator qualifications. Alma Lasers makes no representations regarding 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 credential required by law for clinical use and the operation of the device.
1.5.
Maintenance The Pixel CO2 system is a precision, technical medical device that requires periodic routine maintenance service, which must be performed by Alma Lasers authorized technical personnel. Failure to obtain service voids all warranties expressed and implied. Please contact Alma Lasers or your local representative for details.
Pixel® CO2 Operator's Manual
1-3
System Overview
1.6.
Modification of the System Unauthorized modification of the hardware, software or specifications of the Pixel CO2 system voids all warranties, expressed and implied. Alma Lasers takes no responsibility for the use or operation of such a modified device.
1.7.
Resale Inspection The Pixel CO2 is a precision, technical medical device. If any Alma Lasers device is resold by anyone other than an authorized sales representative, Alma Lasers offers a resale inspection by an Alma Lasers 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, expressed and implied. Alma Lasers 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 contact Alma Lasers or your local representative.
1.8.
1-4
Abbreviations and Acronyms "
Inches
°C
Degree(s) Centigrade/Celsius
°F
Degree(s) Fahrenheit
A
Ampere(s)
AC
Alternating current
CFR
Code of Federal Regulations
cm
Centimeter(s)
CO2
Carbon dioxide
CW
Continuous wave
DC
Direct current
Hz
Hertz
IEC
International Electrotechnical Commission
kg
Kilogram(s)
lbs
Pounds
LCD
Liquid crystal display
Pixel® CO2 Operator's Manual
System Overview
LED
Light emitting diode
mm
Millimeter(s)
ms
Milliseconds
msec
Milliseconds
mW
milliWatts
nm
Nanometers
OD
Optical density
PS
Power supply
Sec
Second(s)
H.V
High voltage
µs
Microseconds
VAC
Volt(s) alternating current
Pixel® CO2 Operator's Manual
1-5
CHAPTER 2 Safety Chapter Contents: Section
Title
2.1.
Introduction ... 2-2
2.2.
System Safety Measures ... 2-2
2.3.
The Treatment Room... 2-4
2.4.
General Precautions and Cautions ... 2-5
2.5.
Warnings Related to Laser Emission... 2-6
2.6.
System Safety Features... 2-7
2.7.
Equipment Classification and Compliance... 2-9
2.8.
Device Labels ... 2-10
Pixel® CO2 Operator's Manual
Page
2-1
Safety
2.1.
Introduction This chapter describes general safety issues regarding the use of the Pixel CO2 system, with special emphasis on optical and electrical safety. Warning Hazardous voltages are energized when the emergency stop button is engaged.
Note Federal law (USA) restricts this device to only be sold to, or on the order of a physician or any practitioner licensed by the law of the state in which he or she practices or intends to use or order the use of the device. With proper operation and maintenance, trained and qualified medical practitioners can use the system safely. The supervising physician and all other personnel operating or maintaining the Pixel CO2 must be familiar with the safety information provided in this chapter. The primary consideration should be for the safety of the patient, the physician and other personnel. Patient safety is mainly assured with a well trained staff and a well laid out treatment room. Patient education is also important, including information about the nature of the treatment.
2.2.
System Safety Measures The Pixel CO2 system was designed to maximize safety for both patient and personnel. The following are some of the Pixel CO2 system's preventive safety measures:
2.2.1.
Electrical Safety Software protection, including:
• The system is protected by a semi-automatic circuit breaker. • The software checks all safety related hardware after the system is switched on.
• Emission timing is regulated by hardware timers. • If an error occurs, the system displays a warning message to the operator and disables further operation.
2-2
Pixel® CO2 Operator's Manual
Safety
2.2.2.
Laser Safety 1.
Precise optical engineering is used to transmit laser energy to the treatment site. Laser energy is emitted only through the front plane of the handpiece.
2.
The system incorporates a safety remote interlock connector for connecting an external interlock on the entrance door to the treatment room. The external remote interlock is serially connected with the footswitch; therefore when installed, disables the system and prevents operation when the entrance door is opened.
3.
An emergency shutoff knob expedites shutdown when necessary. When pressed, it immediately shuts down system operation.
4.
The system features two emission indicators: a red emission indicator lamp incorporated into the emergency stop button, and a buzzer.
• The red emission indicator lamp flashes when the system is ready to trigger pulses, and becomes a continuous light when a laser pulse is emitted.
• The buzzer beeps once when the system switches to Ready mode. 5.
Laser emission is enabled only when the operator switches to Ready mode and presses the footswitch.
6.
Water is circulated through the system as soon as the system is turned on in order to cool the laser resonator. Water flow is monitored and laser emission is disabled if the water flow stops.
7.
The temperature of the water is monitored by a thermal sensor in order to eliminate the risk of overheating. Laser emission is disabled if the water temperature gets higher than the allowed tolerance.
Warning Any laser emitting device can cause injury if used improperly. High voltages are present inside the Pixel CO2 system. Personnel who work with lasers must always be aware of the possible dangers and must take the proper safeguards as described in this manual.
Pixel® CO2 Operator's Manual
2-3
Safety
2.3.
The Treatment Room The treatment room must be clearly labeled with signs indicating that high intensity laser energy is in use. The treatment room sign that is supplied with the Pixel CO2 system is shown in Figure 2-1.
Figure 2-1: Treatment Room Warning Sign
The treatment room should not include any light reflecting objects such as a mirror. Access to the Pixel CO2 treatment room should be allowed only to personnel essential to the procedure and who are well trained in the required safety procedures. Assure that all of the treatment room personnel are familiar with the Pixel CO2 controls and know how to shut down the system instantly.
2-4
Pixel® CO2 Operator's Manual
Safety
2.4.
General Precautions and Cautions The following precautions, cautions and warnings must be observed for the safe use of the Pixel CO2 system.
2.4.1.
Precautions • Physicians and clinicians should read this manual thoroughly before attempting to operate the Pixel CO2 system.
• The handpiece's optical lens must be kept clean at all times. • The system weighs 135 lbs. (61 kg.) and may cause injury if proper care is not used when moving it. The system is well balanced and is designed to be moved, but should always be moved carefully and slowly.
2.4.2.
Cautions • Only Alma Lasers authorized personnel may service the Pixel CO2 system. This includes making internal adjustments to the power supply, cooling system, optics, handpieces, etc.
• Verify that the Pixel CO2 is wired for the appropriate electrical voltage of your country (120VAC or 230VAC).
• Maintenance performed by the operator must only take place when the system is shut down and disconnected from the electrical power source. Performing maintenance procedures with the system powered-up can be hazardous to the operator and/or destructive to the system.
• Always turn off the system when it is not in use. • Never leave the system in Ready mode unattended. • Never allow untrained personnel to operate the system. • Never press the footswitch unless the handpiece is safely oriented at a specific and intended target.
• The laser delivery handpiece must always be visually inspected before treating the patient. If any wear or damage is apparent, do not use the handpiece.
• Never leave the system turned on, open or unattended during system maintenance. Remove the key from the system when unattended.
Pixel® CO2 Operator's Manual
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