pixel_co2_fractional_laser_system_operators_manual.pdf
Page 1
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
Page 2
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: info@almalasers.com
Alma Lasers, Inc.
485 Half Day Road
Suite # 100
Buffalo Grove, IL 60089
Tel: 1-866-414-2562
Fax: 1-954-229-8310
Email: contact@almalasers.com
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
Page 3
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
Page 4
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
Page 5
Scope of Manual
2.8.1.
2.8.2.
CHAPTER 3
Installation
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.8.
3.9.
CHAPTER 4
System Labels ................................................................................. 2-10
Packaging Label............................................................................. 2-14
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
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
iii
Page 6
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
Page 7
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
v
Page 8
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
Page 9
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
vii
Page 10
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
viii
Pixel® CO2 Operator's Manual
Page 11
CHAPTER 1
System Overview
Chapter Contents:
Section
Title
Page
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
1-1
Page 12
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
Page 13
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
Page 14
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
Page 15
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
Page 17
CHAPTER 2
Safety
Chapter Contents:
Section
Title
Page
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
2-1
Page 18
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
Page 19
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
Page 20
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
Page 21
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
2-5
Page 22
Safety
2.5.
2.5.1.
Warnings Related to Laser Emission
Burn Hazards
CO2 laser radiation is invisible to the human eye and can cause third-degree burns,
even when unfocused.
2.5.2.
Direct and Reflected Eye Exposure Hazards
It is essential that all people present in the treatment room during the treatment
(patient and medical personnel) protect their eyes by wearing Alma Lasers
recommended protective eyewear.
The protective eyewear must be labeled according to the wavelength and optical
density for which they offer protection.
It is good practice to instruct the patient to close their eyes during treatment even
when wearing protective eye glasses.
If the patient cannot wear the protective eyewear, fit the patient with opaque eye
protection that completely blocks light from the eyes.
If the treatment area is very close to the eyes (e.g. eyelids), protect the eyes with
corneal shields.
2.5.3.
Explosion and Fire Hazards
• The absorption of optical energy raises the temperature of the absorbing
material. Take precautions to reduce the risk of igniting combustible materials in
and around the treatment area.
• Have water available to extinguish small fires.
• Ensure that a CO2 fire extinguisher is available.
• The system is not suitable for use in the presence of flammable mixtures with air
or oxygen.
• Do not operate in the presence of volatile solvents such as alcohol, gasoline or
other solvents.
• Do not use any flammable substances such as alcohol or acetone in the
preparation of the skin for treatment. If necessary, use soap and water to clean
before treatment.
• If alcohol is used to clean and disinfect any part of the Pixel CO2 system, allow
it to dry thoroughly before operating the system.
• Flammable materials must be kept at a safe distance from the system.
2-6
Pixel® CO2 Operator's Manual
Page 23
Safety
2.5.4.
High Voltage Hazards
The system utilizes high-voltage electricity. To avoid personnel injury, do not
operate the system before ensuring that the exterior panels are properly closed. Do
not attempt to remove or disassemble the exterior panels.
The Pixel CO2 system produces very high voltages in various components. Some
components may retain a charge after the power supply has been turned off, so no
part of the exterior housing should be removed, except by Alma Lasers authorized
personnel.
Whenever system maintenance is performed, never leave the Pixel CO2 system
turned on, open or unattended.
2.5.5.
Grounding the System
The system is grounded through the grounding conductor in the power cable and
internal grounding pin.
2.6.
System Safety Features
The Pixel CO2 system is equipped with a number of safety features. All treatment
room personnel should be familiar with the location and operation of these safety
features.
2.6.1.
Emergency Shut-Off Knob
This red knob is used for emergency shutdown. When pressed, it immediately shuts
off power to the entire system.
To release the emergency shut-off knob, turn it clockwise. Otherwise, the system
will remain off (see Figure 4-1).
2.6.2.
Main Circuit Breaker
A semi-automatic circuit breaker, located on the rear panel, protects the system
against excessive current consumption. The circuit breaker disconnects power to the
system in case of an electrical overload. To resume system operation, lift the circuit
breaker handle.
Pixel® CO2 Operator's Manual
2-7
Page 24
Safety
2.6.3.
Laser Emission Indicators
The system features two laser emission indicators: a red LED located in the
emergency stop button, and a buzzer.
The red LED has three modes:
• Off - when the system is turned on, and in Standby mode
• Blinking – during Ready mode
• Continuous – during laser emission (footswitch is pressed)
The buzzer beeps once when the system switches to Ready mode.
2.6.4.
Laser Safety Shutter
The system is equipped with a manual safety shutter that – when closed – prevents
the CO2 laser beam from being emitted from the articulated arm's endjoint.
The operator must ensure that the shutter's switch is set to the Open position before
attempting to fire the laser.
2.6.5.
Remote Interlock Connector
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, it
disables the system and prevents operation when the entrance door is opened.
2-8
Pixel® CO2 Operator's Manual
Page 25
Safety
2.7.
Equipment Classification and Compliance
• Electrical shock protection: Class I, Type BF
• Protection against ingress of liquids: ordinary equipment
• Not suitable for use in presence of flammable anesthetic mixture with air or
nitrous oxide
The Pixel CO2 system complies with the following standards:
• IEC 60601-1: Medical Electrical Equipment. Part 1: General Requirements for
Safety (Ed. 2:1998 + A1:1993 + A2:1995)
• IEC 60601-1-2: Medical Electrical Equipment: Part 1-2; Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests (Ed. 2.0: 2001
+ A1:2004)
• IEC 60601-2-22: Medical Electrical Equipment - Part 2-22: Particular
Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic,
Therapeutic and Diagnostic Laser Equipment (1995)
• IEC 60825-1: Safety of Laser Products - Part 1: Equipment Classification, and
Requirements (2007)
• IEC 60601-1-2: IEC 60601-1-2 (Ed. 2.0: 2001 Am1:2004), Medical Electrical
Equipment: Part 1-2; Collateral Standard: Electromagnetic Compatibility Requirements and Tests
In compliance with these standards, the system is equipped with:
• Laser emission indicators
• Energy and power display
• Emergency shut-off knob
• Remote 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 (see
Chapter 7).
Pixel® CO2 Operator's Manual
2-9
Page 26
Safety
2.8.
2.8.1.
Device Labels
System Labels
The Warning, Certification and Identification labels shown on the following
pages are adhered to the Pixel CO2 system:
• Identification label, located on the service panel. This label contains the
following information:
Manufacturer's name
System model
Assurance that the system complies with the US Federal Performance
Standards
Serial number and date of manufacture
The system's electrical requirements
CE compliance symbol
Caution: Consult Operating Instructions
Type of protection against electric shock
Label # 1 is adhered to 40W systems shipped to 110VAC countries.
Label # 2 is adhered to 70W systems shipped to 110VAC countries.
Label # 3 is adhered to 40W systems shipped to 230VAC countries.
Label # 4 is adhered to 70W systems shipped to 230VAC countries.
2-10
Pixel® CO2 Operator's Manual