Cutera GenesisPlus Manual de usuario
i
GenesisPlus Operator Manual
D1151, REV C, 10/16
Operator Manual
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GenesisPlus Operator Manual
D1151, REV C, 10/16
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 per-
mission of Cutera, Inc. Permitted copies must carry the same proprietary and copyright notices
as were affixed to the original. Under US federal law, copying includes translations 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 con-
tained herein are subject to change without notice.
Cutera is the registered trademark of Cutera, Inc.
©Cutera, Inc.
October 2016
Published in USA
D1151
Rev C
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
MDSS GmbH
Schiffgraben 41, D-30175
Hanover, Germany
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GenesisPlus Operator Manual
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CONTENTS
OPERATION 1
Introduction 1
System Preparation 2
GenesisPlus System Components 3
System Console 4
Footswitch 4
Remote Interlock Plug 4
Handpiece 4
Connecting the System Components 5
Connecting the Footswitch 5
Inserting the Remote Interlock Plug 5
Connecting the Main Power Cable 5
System Basics 7
Turning On the System 7
Restarting the System 7
Turning Off the System 7
Emergency Off 8
Disconnecting the System 8
Moving the System 8
General System Functions 10
Genesis Control Screen 10
Warts Control Screen 11
System Status: STANDBY and READY Modes 12
Treatment, Aiming and Working Distance Beams 14
Memory Storage 16
Thermal Monitoring 17
Information & Adjustment Screen 19
Audible Tones 20
Audible Pulse Counter 21
Pop-up Screen 22
Displays and Indicators 23
User-selectable Parameters 24
Selecting the Fluence 24
Selecting the Pulse Width 25
Selecting the Repetition Rate (Genesis mode only) 26
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MAINTENANCE 27
Troubleshooting Guide 27
Error Code Guide 31
Annual System Maintenance 32
System Repair 32
Routine User Maintenance 32
Clean the External Surfaces of the System Console 33
Clean the System Touchscreen Display 33
Clean the External Surfaces of the Handpiece 33
Inspect and Clean the Handpiece Lenses 34
Inspect and Clean the Heat Exchanger Intake 36
Fill the Coolant Reservoir 37
Remote Interlock Pin Assignments 38
Electrical Utilities 39
Systems Designed for Use Outside of Europe 39
Systems Designed for Use in European Communities Under MDD 39
Removable or Lockable Wall Socket and Plug Configurations 40
Systems Designed for Use in European Communities Under MDD 40
System Specifications 41
Treatment Beam 41
Physical Parameters 41
Electrical Requirements 42
Environmental Requirements 42
Classifications 42
Eye Safety 42
Calibration Procedure 43
Equipment Required 43
Calibration Instructions 44
End of Life Disposal - Environmental Information 44
Warranty Information 44
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GenesisPlus Operator Manual
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SAFETY AND REGULATORY 45
Introduction 45
Optical Hazard 45
Additional Ocular Protection 47
Additional Safety Considerations 48
Protecting Non-target Tissues 48
Electrical Hazard 48
Fire Hazard 49
Regulatory Compliance 49
Location of Controls 49
Key Lock Switch 49
Emergency Off Push-button 49
Laser Emission Indicator 49
Remote Interlock 50
Protective Housing 50
Laser Safety Shutter 50
Audible Emission Indicator 50
Manual Reset 50
Electronic Fault Detection Circuitry 50
Operational Training 51
Operational Safety 51
Location of Regulatory Compliance Labels 53
Electromagnetic Compatibility 55
CLINICAL APPLICATIONS 59
Indications for Use 59
Dermatology 59
Podiatry 59
Contraindications for Use 60
Precautions 60
Expected Transient Events and Possible Adverse Effects 61
Clinical Guidelines 61
Dermatology 62
Podiatry 63
Patient Information 63
APPENDIX A - LASER WARNING SIGN
APPENDIX B - SYMBOLS
APPENDIX C - BIBLIOGRAPHY
APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS
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THIS PAGE IS BLANK
1
GenesisPlus Operator Manual
D1151, REV C, 10/16
Operation
Introduction
The Cutera GenesisPlus is an Nd:YAG (1064 nm) laser with a patented pulse structure
designed for safe and effective treatment on all skin types, including tanned skin. It is indicated
for use in the medical specialties of general and plastic surgery, dermatology, and podiatry,
among others. Indicated uses include, but are not limited to, the treatment of rosacea and poi-
kiloderma of Civatte, reduction of scars and wrinkles, removal of warts, and the temporary
increase of clear nail in patients with onychomycosis. The effects of the GenesisPlus laser for
rejuvenation are documented in multiple peer-review published studies where the result is
smoother skin with reduced erythema, decreased wrinkles, decreased pore size and an
improvement in overall skin quality.
Key benefits:
• Fast treatments – three times faster than alternative Nd:YAG lasers
• No recurring costs – one time purchase only
• Large spot for uniform coverage
• Integrated temperature feedback
• Safe for all skin types
• Year round application
• Comfortable treatment – no downtime and no need for anesthetic
GenesisPlus is a precision medical instrument. It has undergone extensive testing and with
proper handling is a useful and reliable clinical instrument. If you have any questions regard-
ing your system, contact your local Cutera representative.
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GenesisPlus Operator Manual
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WARNING
Any laser device can generate highly concentrated light, which may
cause injury if improperly used. To protect patients and operating
personnel, this entire operator manual, including the Safety and
Regulatory section, should be carefully read and comprehended
before operation.
System Preparation
The GenesisPlus system is shipped directly from the factory to your site. Your local Cutera
representative will initially uncrate, inspect, set up and install the system to ensure that it is
working properly before use. In addition, Cutera provides in-service and training to ensure that
your staff is experienced with appropriate performance and safety considerations. Thereafter,
you or the staff at your facility will be performing the daily maintenance routines associated
with the system, as well as performing basic system safety checks. These procedures are
detailed later in this chapter and in the Maintenance section of this manual.
Most staff personnel prefer to inspect and perform a functional system check prior to sched-
uled cases. Doing so will ensure adequate time to troubleshoot problems or to contact your ser-
vice representative with the least amount of disruption to patients and schedules.
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GenesisPlus Operator Manual
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GenesisPlus System Components
The GenesisPlus system consists of a system console, a laser handpiece, a handpiece cradle, a
touchscreen control panel and a footswitch. Other components necessary for operation, such as
a remote interlock plug and all electrical cables, are also included.
Footswitch
System console
Remote interlock plug
Laser handpiece
in handpiece cradle Touchscreen
control panel
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GenesisPlus Operator Manual
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System Console
The system console houses the touchscreen control panel, the main power keyswitch, emer-
gency off switch, control electronics, the 1064 nm laser umbilical with handpiece, the laser
source with associated optics and power supply. The touchscreen control panel allows you to
select treatment settings.
NOTE
To ensure proper air circulation, the console must be positioned at
least 20 centimeters (8 inches) from walls, furniture or other equip-
ment.
Footswitch
The footswitch activates the treatment beam when the system is in READY mode.
Remote Interlock Plug
The system is equipped with a remote interlock plug which, when wired to an external door
switch, shuts down the system power if the treatment room door is opened or the interlock plug
is removed. To resume treatment, close the treatment room door or reinsert the remote inter-
lock plug, and restart the system using the keyswitch.
Use of an external door switch is optional; however, the remote interlock plug must be inserted
into the interlock receptacle at all times for proper operation.
NOTE
Refer to the Maintenance section of this operator manual for
instructions on connecting an external door switch to the remote
interlock plug.
Handpiece
The handpiece delivers laser energy from the system console to the treatment site. An inte-
grated temperature sensor and LED temperature indicators enable thermal monitoring of the
target tissue. A working distance beam ensures proper positioning of the handpiece when cen-
tered within the aiming beam.
Este manual sirve para los siguientes modelos
1
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