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.
©October 2017 Cutera, Inc.
Published in USA
D1025
Revision H
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

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Contents
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Characteristics of the 532 nm KTP Laser Beam . . . . . . . . . . . . . . . . . . . . . . . 2
Characteristics of the 1064 nm Nd:YAG 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
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
System Status: STANDBY and READY Modes . . . . . . . . . . . . . . . . . . . . . . 20

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Memory Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Information & Adjustment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Aiming Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Audible Tones and Voice Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
User-selectable Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
CoolView Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Selecting Treatment Parameters in Navigation Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Exiting Navigation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Selecting Treatment Parameters in Expert Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Selecting the Laser Wavelength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Selecting the Laser Spot Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Selecting the Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Selecting the Pulse Duration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Selecting the Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Adjusting the Temperature of the Sapphire Cooling Window . . . . . . . . . . . . . . . . . . . . . . 43
Genesis V Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Selecting the Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Selecting the Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
System Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Routine User Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . 51
Cleaning the System Touchscreen Display. . . . . . . . . . . . . . . . . . . . . . . . . . 51
Inspecting and Cleaning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Inspecting and Cleaning the External Surfaces of the Handpiece . . . . . . . . . . . . . . . . . . 53
Inspecting and Cleaning the Handpiece Lens(es) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Inspecting and Cleaning the CoolView Handpiece Window . . . . . . . . . . . . . . . . . . . . . . . 56
Inspecting and Cleaning the Heat Exchanger Intake . . . . . . . . . . . . . . . . . . 58
Filling the Coolant Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Remote Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

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Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Systems Designed for Use Outside of Europe . . . . . . . . . . . . . . . . . . . . . . . 61
Systems Designed for Use in European Communities Under MDD . . . . . . . 61
Removable or Lockable Wall Socket and Plug Configurations . . . . . . . . . . . 61
Systems Designed for Use in European Communities Under MDD . . . . . . . . . . . . . . . . . 61
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Maximum Allowable Temperature of Accessible Parts . . . . . . . . . . . . . . . . . 63
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Eye Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Calibration Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . 66
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Additional Ocular Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Electrical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Emergency Off Push-Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Laser Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

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Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Location of Regulatory Compliance Labels. . . . . . . . . . . . . . . . . . . . . . . . . . 76
Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
General Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
532 nm KTP Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
1064 nm Nd:YAG Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Expected Transient Events and Possible Adverse Effects. . . . . . . . . . . . . . . . . . 85
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Treatment Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
APPENDIX A - LASER WARNING SIGN
APPENDIX B - SYMBOLS
APPENDIX C - BIBLIOGRAPHY
APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS

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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.

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Characteristics of the 532 nm KTP Laser Beam
The 532 nm laser wavelength falls in the visible region of the electromagnetic spectrum and produces
green light. The KTP 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 Nd:YAG 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 Nd:YAG laser light is a longer penetrating
wavelength that is absorbed by melanin and hemoglobin in target tissues. This makes the Nd:YAG 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.

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Excel V System Components
The Excel V consists of a system console with a boom and handpiece holster(s), handpiece(s) and a
footswitch. Other components necessary for operation, such as remote interlock plug and all electrical
cables, are also included.
System Console
The system console houses the touchscreen control panel, main power keyswitch, emergency off switch,
control electronics, laser source with associated optics and power supply. The touchscreen control panel
allows you to select treatment settings.
Handpieces
The laser handpiece delivers laser energy from the system console to the treatment site. Two
ergonomically designed handpieces are available for use with the Excel V: CoolView and Genesis V.
The CoolView handpiece features integrated motorized zoom and epidermal cooling. The motorized
zoom feature enables you to adjust the laser spot size from 2 to 12 mm. The epidermal cooling feature
allows you to adjust the temperature of the sapphire cooling window to increase safety and efficacy.
The Genesis V handpiece features an integrated temperature sensor and LED temperature indicators,
which enable thermal monitoring of the target tissue. A working distance beam ensures proper
positioning of the handpiece when centered within the aiming beam.
Footswitch
The footswitch activates the laser treatment beam.
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.

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Boom
CoolView Handpiece
Genesis V Handpiece
Footswitch
Remote interlock plug System console
(dual handpiece model shown)
Holsters