Cutera Excel V+ User manual

I
Operator Manual

ii
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 Cutera, Inc. Permitted copies
must carry the same proprietary and copyright notices as were affixed to the original. Under the 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 contained herein are subject to change
without notice.
Cutera is the registered trademark of Cutera, Inc.
©February 2019 Cutera, Inc.
Published in USA
D2325
Revision A
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
MDSS GmbH
Schiffgraben 41, D-30175
Hannover, Germany
Australian Sponsor
Cutera Australia, Pty. Ltd.
PO Box 774
Maroubra, NSW 2035

iii
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
Contents
CONTENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Characteristics of the 532 nm Laser Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Characteristics of the 1064 nm Laser Beam . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
excel V+ System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Remote Interlock Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Connecting the System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Inserting the Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Handpiece Dummy Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connecting the Main Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

iv
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Turning On the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Restarting the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Turning Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Emergency Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Disconnecting the Handpiece Fiber Connector. . . . . . . . . . . . . . . . . . . . . . . 12
Disconnecting the Handpiece Connector or Dummy Plug . . . . . . . . . . . . . . 12
Disconnecting the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
General System Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
CoolView Handpiece User Interface Modes . . . . . . . . . . . . . . . . . . . . . . . . . 15
CoolView Select Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
CoolView Treatment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Genesis V Treatment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Dermastat Treatment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
System Status: STANDBY and READY Modes . . . . . . . . . . . . . . . . . . . . . . 21
Memory Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Information & Adjustment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Aiming Beam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Audible Tones and Voice Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
User-selectable Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
CoolView Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Selecting Treatment Parameters in Navigation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Exiting Navigation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Selecting Treatment Parameters in Expert Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Selecting the Laser Wavelength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Selecting the Laser Spot Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Selecting the Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Selecting the Pulse Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Selecting the Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Adjusting the Temperature of the Sapphire Cooling Window . . . . . . . . . . . . . . . . . . . . . .45

v
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
Genesis V Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Selecting the Laser Wavelength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Selecting the Fluence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Selecting the Pulse Duration (532 nm only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Selecting the Repetition Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Dermastat Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Selecting the Fluence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Selecting the Pulse Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Selecting the Repetition Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Troubleshooting Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
System Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Routine User Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . 57
Cleaning the System Touchscreen Display. . . . . . . . . . . . . . . . . . . . . . . . . . 57
Inspecting and Cleaning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Inspecting and Cleaning the External Surfaces of the Handpiece . . . . . . . . . . . . . . . . . . 59
Inspecting and Cleaning the Handpiece Lens(es) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Inspecting and Cleaning the CoolView Handpiece Window. . . . . . . . . . . . . . . . . . . . . . . 62
Inspecting and Cleaning the Heat Exchanger Intake . . . . . . . . . . . . . . . . . . 64
Filling the Coolant Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Remote Interlock Pin Assignments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Systems Designed for Use Outside of Europe . . . . . . . . . . . . . . . . . . . . . . . 67
Systems Designed for Use in European Communities Under MDD . . . . . . . 67
Removable or Lockable Wall Socket and Plug Configurations . . . . . . . . . . . 67
Systems Designed for Use in European Communities Under MDD. . . . . . . . . . . . . . . . . 67
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

vi
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Maximum Allowable Temperature of Accessible Parts . . . . . . . . . . . . . . . . . 69
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Eye Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Calibration Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . 72
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Additional Ocular Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Electrical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Operational Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Emergency Off Push-Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Laser Emission Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

vii
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Regulatory Compliance Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
System Console Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Handpiece Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
General Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
532 nm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
1064 nm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Expected Transient Events and Possible Adverse Effects. . . . . . . . . . . . . . . . . . 93
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Treatment Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
APPENDIX A - LASER WARNING SIGN
APPENDIX B - SYMBOLS
APPENDIX C - BIBLIOGRAPHY
APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS

viii
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
THIS PAGE IS LEFT BLANK

1
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
Operation
Introduction
The Cutera excel V+ is a dual-wavelength (532 and 1064 nm) laser system that treats a wide range of
dermatologic conditions. Various laser pulse fluence, spot size, and pulse duration parameter
combinations can be used to treat unwanted veins, benign vascular lesions and birthmarks, and benign
pigmented lesions.
The excel V+ 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 regarding your system,
contact your local Cutera representative.
WARNING
Any laser device can generate highly concentrated light which may
cause injury if improperly used. To protect patients and operating
personnel, the entire system operator manual, including the Safety
and Regulatory sections, should be carefully read and
comprehended before operation.

2
EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
Characteristics of the 532 nm Laser Beam
The 532 nm laser wavelength falls in the visible region of the electromagnetic spectrum and produces
green light. The 532 nm laser light is absorbed by hemoglobin and melanin in target tissues. This makes
the 532 nm laser useful for treating multiple indications. See the Clinical Applications section for specific
Indications for Use for the 532 nm wavelength.
Characteristics of the 1064 nm Laser Beam
The 1064 nm laser wavelength falls in the near infrared region of the electromagnetic spectrum. This
wavelength is invisible to the human eye; therefore, a low power, visible aiming beam that is coaxial with
the invisible treatment beam is used to target tissue. The 1064 nm laser light is a longer penetrating
wavelength that is absorbed by melanin and hemoglobin in target tissues. This makes the 1064 nm laser
useful for treating multiple indications. See the Clinical Applications section for specific Indications for
Use for the 1064 nm wavelength.
System Preparation
The excel V+ 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 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.
We recommend that you or your staff inspect and perform a functional system check prior to scheduled
cases. Doing so will ensure adequate time to troubleshoot problems or contact your service
representative with the least amount of disruption to patients and schedules.