Cutera Excel HR User manual

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 per-
mission 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 lan-
guage.
Please note that while every effort has been made to ensure that the data given in this docu-
ment 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.
©December 2016 Cutera, Inc.
Published in USA
D1796
Revision D
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
MDSS GmbH
Schiffgraben 41, D-30175
Hannover, Germany

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Contents
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Characteristics of the 755 nm Alexandrite Laser Beam . . . . . . . . . . . . . . . . . 1
Characteristics of the 1064 nm Nd:YAG Laser Beam. . . . . . . . . . . . . . . . . . . 2
System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Verifying the Integrity of the Delivery System . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Remote Interlock Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Connecting the System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Inserting the Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Main Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Display Screens and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

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Select Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Treatment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Information & Adjustment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
System Status: STANDBY and READY Modes . . . . . . . . . . . . . . . . . . . . . . 14
Aiming Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Memory Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Audible Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Pop-up Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
User-selectable Treatment Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Selecting the Laser Wavelength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Selecting the Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Selecting the Pulse Width (1064 nm only) . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Selecting the Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Selecting the Spot Size. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Selecting the Temperature of the Sapphire Cooling Window . . . . . . . . . . . . 25
Cleaning the Handpiece During Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Treatments without gel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Treatments with gel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
System Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Routine User Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . 34
Cleaning the System Touchscreen Display. . . . . . . . . . . . . . . . . . . . . . . . . . 34
Inspecting and Cleaning the Heat Exchanger Intake . . . . . . . . . . . . . . . . . . 35
Filling the Coolant Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Inspecting and Cleaning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Inspecting and Cleaning the Handpiece Holster. . . . . . . . . . . . . . . . . . . . . . 42
Remote Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Maximum Allowable Temperature of Accessible Parts . . . . . . . . . . . . . . . . . 45
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Eyewear Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
755 nm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
1064 nm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . 48
SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Additional Ocular Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Electrical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Emergency Off Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Laser Emission Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Location of Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . 59
Regulatory Compliance Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

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Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
1064 nm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
755 nm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Expected Transient Events and Possible Adverse Effects . . . . . . . . . . . . . . . . . 69
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Hair Removal Treatment Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Hair Removal Technique and Endpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Vascular Lesion Treatment Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Vascular Lesion Technique and Endpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Benign Pigmented Lesion Treatment Guidelines - 755 nm Only . . . . . . . . . . . . . 76
Benign Pigmented Lesion Technique and Endpoints. . . . . . . . . . . . . . . . . . . . . . 76
Wrinkle Treatment Guidelines - 1064 nm Only . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
APPENDIX A - LASER WARNING SIGN
APPENDIX B - SYMBOLS
APPENDIX C - CUTERA DIRECT OFFICE LOCATIONS

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Operation
Introduction
The Cutera excel HR is a dual-wavelength (755 nm Alexandrite and 1064 nm Nd:YAG) laser system that
treats a wide range of dermatologic conditions requiring selective photothermolysis of target
chromophores. This operator manual describes the use and operation of the excel HR, including the
permanently attached handpiece.
Cutera lasers and handpieces are precision medical instruments. They have undergone extensive
testing and, with proper handling, are useful and reliable clinical instruments. If you have any questions
regarding your laser and/or handpiece(s), contact your local Cutera representative.
Any laser device can generate highly concentrated light, which may
cause injury if improperly used. To protect patients and operating
personnel, read and comprehend this entire operator manual,
including the Safety and Regulatory chapter, before operation.
Characteristics of the 755 nm Alexandrite Laser Beam
The 755 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 Alexandrite laser light is absorbed by
hemoglobin and melanin in target tissues. This makes the 755 nm laser useful for treating multiple
indications. See the Clinical Applications section for specific Indications for Use for the 755 nm
wavelength.
WARNING

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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
Your laser 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
Canada, the system should be installed and operated in accordance with CAN/CSA Z386 (2014): Safe
Use of Lasers in Health Care Facilities. 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 chapter of this manual.
We recommend that you or your staff inspect and perform a functional system check, including delivery
system verification, 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.
Verifying the Integrity of the Delivery System
The aiming beam is coaxial with the treatment beam and, therefore, provides a good means of verifying
the integrity of the delivery system (i.e., handpiece and umbilical cable). Verify the integrity of the delivery
system daily to ensure that it is not damaged or malfunctioning.
After turning on the system, place it in READY mode, and direct the aiming beam at a non-reflective
surface. If the aiming beam is not present at the distal end of the handpiece, if its intensity is reduced, or
if it looks diffused, then the handpiece and/or cable may be damaged or malfunctioning. Do not use the
handpiece; contact Cutera Service (refer to Appendix C).

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System Components
The excel HR consists of a system console with a boom and handpiece holster, a handpiece and a
footswitch. Other components necessary for operation, such as an external door 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.
Handpiece
The handpiece delivers laser energy from the system console to the treatment site and provides
epidermal cooling. The handpiece is permanently attached to the system console with an umbilical cable.
Footswitch
The footswitch activates the 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.

Footswitch
Remote interlock plug
Holster
System console
Boom
Handpiece
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