D1492 Re OPMAN, EXCEL HR, ENGLISH

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.
©February 2016 Cutera, Inc.

Published in USA
D1492
Revision E
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
MDSS GmbH
Schiffgraben 41, D-30175
Hannover, Germany
EXCEL HR OPERATOR MANUAL

D1492, REV. E, 02/16
iii
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

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Disconnecting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Display Screens and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Selecting the Temperature of the Sapphire Cooling Window . . . . . . . . . . . . . . .26
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
System Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Routine User Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . . . . . . . .32
Cleaning the System Touchscreen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Inspecting and Cleaning the Heat Exchanger Intake . . . . . . . . . . . . . . . . . . . . . . . . .33
Filling the Coolant Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Inspecting and Cleaning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Inspecting and Cleaning the External Surfaces of the Handpiece . . . . . . . . . . .36
Inspecting and Cleaning the Handpiece Lens . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Inspecting and Cleaning the Cooling Window . . . . . . . . . . . . . . . . . . . . . . . . . .38

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Remote Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Maximum Allowable Temperature of Accessible Parts. . . . . . . . . . . . . . . . . . . . . . . . 42
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Eyewear Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
755 nm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
1064 nm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Additional Ocular Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Electrical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Emergency Off Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Laser Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

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Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Location of Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
General Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

755 nm Alexandrite Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
1064 nm Nd:YAG Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Expected Transient Events and Possible Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . .68
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
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.
WARNING
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.

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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
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.

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Boom
Handpiece
Holster
Remote interlock plug
System console Footswitch

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Connecting the System Components

Before connecting the system components, inspect the individual components, cables and electrical
connections for any dirt, debris or damage. Check all electrical cables to ensure they are not frayed or
split. Inspect the handpiece, as instructed in the Maintenance chapter of this manual.
WARNING
Always turn off the system before inspecting the handpiece. Never
look directly into the handpiece even when wearing protective
eyewear. Never look directly into the treatment beam or at scattered
light from metallic or other reflective surfaces. Doing so can cause
permanent eye damage.
Connecting the Footswitch
Plug the footswitch cable into the footswitch receptacle on the rear of the system console. If the
footswitch is not properly connected when the system is turned on, a pop-up screen with an animated
illustration displays on the touchscreen and the system cannot be placed into READY mode.
Inserting the Remote Interlock Plug
Insert the remote interlock plug into the interlock receptacle on the rear of the system console. The
remote interlock plug must be inserted into the interlock receptacle at all times, whether or not an
external door switch is used.
When using an external door switch, the system completely shuts down if the treatment room door is
opened or the remote interlock plug is removed. To resume treatment, close the treatment room door or
reinsert the remote interlock plug, and restart the system using the keyswitch.
Footswitch receptacle
Interlock receptacle

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Connecting the Main Power Cable

1. Ensure that the system main power circuit breaker is off (down) and that the system
keyswitch is in the O (off) position.
2. Insert the mains power cord plug into the appropriate wall socket, and turn on the main
electrical service.
3. Set the system main power circuit breaker to the on (up) position.
Main power
circuit breaker

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System Basics
Turning On the System
Insert the key in the keyswitch, turn to the (start) position, HOLD FOR FIVE SECONDS, and release.
Upon release, the key automatically springs back to the l (on) position.
Keyswitch
The touchscreen displays the start-up screen, and the system begins a self-test routine. After
approximately 30 seconds, the system emits an audible tone, and the touchscreen displays the Select
screen. If any fault conditions, advisory messages or error codes appear in the pop-up display during
self-test, refer to the Troubleshooting section of this manual.
Restarting the System

To restart the system:
1. Turn the keyswitch to the O (off) position.
2. WAIT 5 SECONDS before turning the keyswitch to the (start) position. Release the
key. The system will go through its normal start-up sequence.
Turning Off the System
Under normal operating conditions, turn the keyswitch to the O (off) position.
NOTE
When the main power cable is connected to the electrical source,
some internal circuits remain energized. To de-energize all the
internal circuits, turn off the main power circuit breaker and
disconnect the electrical service.

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Emergency Off
In an emergency, press the red emergency off button to immediately turn off the system.
Emergency off button
Disconnecting the System

2. Set the system main power circuit breaker to the off (down) position.
3. Remove the power plug from the electrical outlet, and wrap the power cable around the
power cable wrap.
4. Place the footswitch on the upper power cable wrap. Coil the footswitch cable and store it
inside the footswitch holder. Do not wrap the footswitch cable around the power cable
wrap.
5. Store the handpiece in the compartment at the front of the console.
CAUTION
When storing the handpiece, do not coil the umbilical too tightly, as
damage to the internal optical fiber will occur.

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Moving the System
1. Disconnect the system and store the handpiece as described above.
CAUTION
Always disconnect the system when moving the system any
distance other than within one room. The handpiece may be
dislodged from the holster when the system is moved over
thresholds or uneven surfaces. Damage will occur to the handpiece
if dropped.
2. Replace the vented filler cap with a sealed filler cap to prevent water from leaking.
WARNING
Water must be drained from the system if the system is stored in
temperatures below freezing. Freezing may result in damage to
critical or delicate components.
3. Unlock the console wheels by disengaging the wheel locks.
4. Move the system console to the desired site. Position the console no less than 20
centimeters (8 inches) from walls, furniture or other equipment. Adequate space around
the system console ensures proper air circulation.
WARNING
Do not push the console over a threshold or other obstacle greater
than 10 mm in height. Doing so may cause the console to tilt,
resulting in user injury.
CAUTION
Never use the handpiece or umbilical cable to move the system.
Moving the system using the handpiece or umbilical may irreparably
damage the handpiece and/or umbilical.
5. Lock the console wheels by engaging each wheel lock.

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Display Screens and Controls

Select Screen
After the console has been turned on and the system self-test has been completed, the Select screen
displays, and the system is automatically placed in STANDBY mode. In STANDBY, the footswitch is
disabled and no treatment energy is available.
Touch the button for the desired wavelength to go to the corresponding Treatment screen.
Touch to select 755 nm Touch to select 1064 nm

wavelength and go to wavelength and go to
corresponding corresponding
Treatment screen Treatment screen
Select Screen

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Treatment Screen
The Treatment screen is accessed by touching the button for the desired wavelength on the Select
screen. The Treatment screen allows you to:
• select the fluence, pulse width (1064 nm only), repetition rate and spot size (refer to the
User-selectable Treatment Parameters topic)
• adjust the temperature of the sapphire cooling window (refer to the User-selectable
Treatment Parameters topic)
• store and recall frequently used treatment parameters (refer to the Memory Storage topic)
• view and reset the pulse counter (refer to the Displays and Indicators topic)
• select the system status (refer to the System Status: STANDBY and READY Modes topic)
• go to the Select screen (refer to the Select Screen topic)
• go to the Information & Adjustment screen (refer to the Information & Adjustment Screen
topic)
Pulse width display
Go to Select Screen Go to Information &

Adjustment screen
Fluence display and Repetition rate

controls display and controls
Memory buttons
STANDBY button READY button
Temperature display Spot size display

and controls Pulse counter and and controls
reset button
755 nm Treatment Screen (STANDBY mode shown)

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Pulse width display

and controls
Go to Select Screen Go to Information &

Adjustment screen
Fluence display and Repetition rate

controls display and controls
Memory buttons
STANDBY button READY button
Temperature display Spot size display

and controls Pulse counter and and controls
reset button
1064 nm Treatment Screen (STANDBY mode shown)

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Information & Adjustment Screen
The Information & Adjustment screen is accessed by touching the tab in the upper right corner of the
Treatment screen while the system is in STANDBY mode. From the Information & Adjustment screen you
can:
• view the total number of pulses ever recorded while using the laser handpiece
• adjust the volume of the emission indicator and other audible tones (refer to the Audible
Tones topic)
• adjust the touchscreen backlighting
• adjust the aiming beam (refer to the Aiming Beam topic)
• view the software version for the system controller, display and handpiece
• go back to the Treatment screen (refer to the Treatment Screen topic)
Go to Treatment
screen
Total number of
pulses recorded
Backlighting
controls
Volume controls Software

versions
Aiming beam
button
Information & Adjustment Screen

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System Status: STANDBY and READY Modes

The system automatically goes into STANDBY mode at system start-up. In STANDBY mode:
• the footswitch is disabled
• the internal safety shutter is closed
• the treatment and aiming beams are not available
• the fluence (J/cm2), pulse width (msec) and repetition rate (Hz) fields are outlined in yellow
• the STANDBY button illuminates
755 nm Treatment Screen in STANDBY Mode
Touch the READY button to toggle to READY mode. In READY mode:
• the footswitch is enabled
• the safety shutter is open
• the treatment and aiming beams are available
• the fluence (J/cm2), pulse width (msec) and repetition rate (Hz) fields are outlined in green
• the READY button illuminates
When the system is in READY mode and the footswitch is pressed, treatment energy is discharged from
the handpiece, the system emits an audible tone, and a yellow indicator next to the READY button
illuminates to indicate treatment beam emission.

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755 nm Treatment Screen in READY Mode
WARNING
Except during actual treatment, the system must always be in
STANDBY mode. Maintaining the system in STANDBY mode
prevents accidental treatment beam exposure if the footswitch is
inadvertently pressed.
WARNING
Verify that all persons in the treatment room are wearing appropriate
treatment beam safety eyewear before placing the system in
READY mode.
NOTE
If the console is not used for three minutes, the system
automatically reverts to STANDBY mode.

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Aiming Beam
The aiming beam is a low power, visible laser beam that is coaxial with the treatment beam and is used
to target the treatment area. All aiming beam functions are controlled from the touchscreen display. To
adjust the intensity of the aiming beam:
1. Touch the tab in the upper right corner of the Treatment screen to go to the Information
& Adjustment screen.
2. Point the laser handpiece at the targeted treatment site.
3. Touch the aiming beam button to toggle through the modes and intensities. There are four
intensities in continuous and blink modes, as well as an OFF mode.
4. Touch the (back) button to return to the Treatment screen.
Four intensities in Four intensities

continuous mode in blink mode
Location of Aiming Beam Button on Information & Adjustment Screen

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Memory Storage
The memory storage feature enables you to store and recall frequently used treatment settings. There
are two memory banks in the memory storage feature, allowing for storage of two different sets of
treatment settings.
Touch and hold memory button 1 or 2 for more than three seconds to save the fluence, pulse width and
repetition rate settings currently displayed on the Treatment screen. Touch and hold memory button 1 or
2 for less than three seconds to recall the previously stored treatment settings.
NOTE
When storing or recalling treatment settings, you must touch and
hold the memory button until an audible tone is heard. Two beeps
will sound when storing treatment settings and one beep will sound
when recalling settings. Any existing treatment settings stored in
memory will be overwritten with new settings.
Location of Memory Buttons on 755 nm Treatment Screen

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Displays and Indicators

The system also includes various indicators and controls to ensure safe and accurate operation.
• Pulse counter display and reset button

The console records and displays the total number of treatment pulses delivered since
the last button reset.
• Emission indicator
The emission indicator illuminates during treatment beam emission (i.e., when the
system is in READY mode and the footswitch is pressed).
Emission indicator
Pulse counter display
Pulse counter reset button
Location of Displays and Indicators on 755 nm Treatment Screen

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Audible Tones
The system console emits an audible tone with every control screen selection, during treatment exposure
and when an error condition has occurred.
NOTE
If the laser output is greater than 120% of the requested energy, the
regular exposure tone is replaced by a higher-pitched tone. If the
laser output is less than 80% of the requested energy, the regular
exposure tone is replaced by a lower-pitched tone.
The volume of audible tones can be increased from the minimum setting up to a setting at which the
tones can be clearly heard over the system sound level. To adjust the volume of audible tones, touch the
tab in the upper right corner of the Treatment screen to go to the Information & Adjustment screen.
NOTE
The volume of audible tones cannot be muted.
Location of Volume Controls on Information & Adjustment Screen

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Pop-up Screens
When the system detects an abnormality during self-test or while the system is in READY mode, a pop-
up screen with the corresponding error code(s) displays on the touchscreen.
Sample Pop-up Screen with Error Codes
Depending upon the fault detected, some faults display an animated illustration (e.g., footswitch
disconnected or water low).
“Connect Footswitch” Pop-up Screen
If the error is successfully cleared, the pop-up screen can be cleared by touching the (back) button
in the upper left corner of the screen. If the error cannot be cleared, or if the error persists or reappears,
note the error code(s) and contact Cutera Service (refer to Appendix C).

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User-selectable Treatment Parameters

In pulsed lasers, such as excel HR, fluence and pulse duration affect the nature of laser-tissue
interaction. The excel HR system has sufficient laser peak power to allow for a wide range of fluence and
pulse duration combinations, enabling you to select optimal tissue interaction parameters. Even very
small target tissues may be targeted with sufficient fluence, at appropriately small pulse durations, to
achieve selective photothermolysis effects.
NOTE
Treatment parameters are interrelated. Therefore, not all parameter
combinations are simultaneously available. If you attempt to select
a treatment setting that is not available, the system emits a distinct
audible tone. Changing one or more of the other parameters may
enable you to select the desired treatment setting.
Selecting the Laser Wavelength

The excel HR features two wavelengths: 755 nm and 1064 nm. Touch the button for the desired
wavelength to go to the corresponding Treatment screen.
Location of Wavelength Buttons on Select Screen

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Selecting the Fluence
Fluence is defined as energy per unit area and is measured in joules per square centimeter (J/cm2).
Select the desired fluence by pressing the and buttons in the (fluence) field.
CAUTION
The fluence shown in the display indicates the fluence delivered to
the tissue.
Location of Fluence Controls and Display on 755 nm Treatment Screen

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Selecting the Pulse Width (1064 nm only)

Pulse width, or duration, refers to the amount of time during which therapeutically effective treatment
energy is delivered; it is measured in milliseconds (ms). Select the desired pulse width by pressing the
and buttons in the (pulse width) field.
NOTE
The pulse width is fixed at 3 ms for the 755 nm Alexandrite
wavelength.
Location of Pulse Width Controls and Display on 1064 nm Treatment Screen

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Selecting the Repetition Rate

Repetition rate refers to the number of treatment pulses delivered per second and is measured in hertz
(Hz). The repetition rate determines the speed at which you work. Select the desired repetition rate by
pressing the and buttons in the (repetition rate) field.
Location of Repetition Rate Controls and Display on 755 nm Treatment Screen

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Selecting the Spot Size

Spot size refers to the size of the treatment spot emitted from the laser handpiece. Select the desired
spot size by pressing the and buttons in the (spot size) field.
Location of Spot Size Controls and Display on 755 nm Treatment Screen

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Selecting the Temperature of the Sapphire Cooling Window

The excel HR handpiece features an integrated sapphire cooling window, which allows you to adjust
epidermal cooling to increase safety and efficacy. Select the desired temperature of the cooling window
by pressing the and buttons in the (temperature) field.
Location of Temperature Controls and Display on 755 nm Treatment Screen

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Maintenance
Troubleshooting Guide
If your system fails to operate properly, this troubleshooting guide will help you to locate and correct any
problems. First, please check for the following items:
1. Electrical power source...verify that the electrical disconnect switch (i.e., circuit breaker) is
in the on (up) position.
2. System console electrical...verify that the system is on and properly connected to an

electrical service outlet.
3. Remote Interlock...verify that the remote interlock plug is inserted into the interlock
receptacle. If the remote interlock plug is used in conjunction with an external door switch,
verify that the treatment room door is closed.
System does not turn on. The touchscreen does not illuminate.
Probable Cause: The system is not plugged in.
Suggestion: Place the system main power circuit breaker in the off (down) position,
insert the system electrical power cord plug into the appropriate outlet,
and place the system main power circuit breaker in the on (up) position.
Turn the keyswitch to the start position.
Probable Cause: The building power (main electrical service) is turned off.
Suggestion: Turn on the building power or reset the room circuit breaker.
Probable Cause: The system main power circuit breaker is in the off (down) position.
Suggestion: Place the system main power circuit breaker in the on (up) position.

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Probable Cause: The electrical outlet is defective.

Suggestion: Use another outlet or have the outlet professionally tested and, if
appropriate, repaired.
Probable Cause: The remote interlock plug is not connected to the system console.
Suggestion: Insert the remote interlock plug into the interlock receptacle, and then
turn the keyswitch to the start position.
The treatment beam is not present, although aiming beam operates properly.
Probable Cause: There is an internal system failure.
Suggestion: Contact Cutera Service (refer to Appendix C).
The treatment beam and aiming beam are not present. Touchscreen displays
and indicators are normal.
Probable Cause: The system is in STANDBY mode.
Suggestion: Place the system in READY mode.
Probable Cause: There is an internal system failure.

Suggestion: Contact Cutera Service (refer to Appendix C).
Inadequate or no aiming beam.

Probable Cause: The aiming beam is either set to “OFF” or at a low setting.
Suggestion: Adjust the aiming beam intensity on the
Information & Adjustment screen. If adjusting the aiming beam does not
resolve the problem, contact Cutera Service (refer to Appendix C).
Low or no energy output (patient reports no sensation).

Probable Cause: The handpiece window is dirty or damaged.
Suggestion: Using a test area, such as an arm, confirm that the handpiece is not
emitting a treatment beam. Check to see if the aiming beam is present.
Clean or replace the handpiece window as described in the Routine User
Maintenance section of this manual. If the problem is not resolved,
contact Cutera Service (refer to Appendix C).
System displays E224 during a procedure.

Probable Cause: The handpiece cooling tip is above the preset temperature.
Suggestion: Do not use a thick layer of gel, as this increases the cooling
requirement.
Ensure that the heat exchanger on the bottom of the system is free of
dust and debris. See the Routine User Maintenance section.
Ensure that the room temperature is below 27° C.

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“Connect Footswitch” advisory pop-up screen appears on the touchscreen

with its corresponding error code(s).
Probable Cause: The footswitch is not properly connected to the console.
Suggestion: Ensure that the footswitch is properly connected to the console. Touch
the (back) button in the upper left corner of the pop-up screen to
clear the advisory message.
“Water Low” advisory pop-up screen appears on the touchscreen.

Probable Cause: The system is low on water.
Suggestion: Turn off the system, and add water as instructed in the Routine User
Maintenance section. Restart the system to continue with treatments.

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System shuts down during operation with no touchscreen display.

Probable Cause: The building power (main electrical service) has been interrupted.
Suggestion: Verify and/or turn on the building power.
Probable Cause: The system main power circuit breaker has tripped.
Suggestion: Place the system main power circuit breaker in the on (up) position.
Probable Cause: The remote interlock is in use, and the treatment room door has been
opened.
Suggestion: Close the treatment room door, and restart the system.

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Error Code Guide

The excel HR uses state-of-the-art, self-diagnostic software. When the system detects an abnormality
during self-test or while the system is in READY mode, a pop-up screen displays with the corresponding
error code(s). Some errors serve as a warning and are clearable by touching the button in the pop-
up screen. Others, such as “connect footswitch” and “water low”, are accompanied by an animated
illustration showing what action to take. If the error or abnormal condition is successfully cleared, the
pop-up screen can be cleared by touching the button.
Below is a brief explanation of some of the codes that may be seen in the advisory pop-up screen. If you
have any questions about this information or the operation and service of your system, contact Cutera
Service (refer to Appendix C).
Error Code Series/Description
Series 100 Codes - Series 100 Codes appear as a warning and typically will not
hinder treatment(s). Most Series 100 Codes are clearable by resuming
treatment or by touching the button. If after touching the button the code
does not clear, power off and re-start the system.
Series 200 Codes - Series 200 codes are “user clearable” faults and must be
cleared in order to resume treatment(s). To clear, touch the button. If after
touching the button the code does not clear, power off and re-start the
system.
Series 300 Codes - Series 300 codes indicate a “permanent fault” and the
system must be powered off and re-started to clear the code. If this action fails
to clear the code, contact Cutera Service (refer to Appendix C) to schedule an
appointment.
* Contact Cutera Service (refer to Appendix C) if additional alert codes appear.
If any error codes or symptoms occur that are not addressed in the troubleshooting guide or if the
suggested solutions do not resolve the problem, contact Cutera Service (refer to Appendix C).

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Annual System Maintenance

Preventive maintenance, safety, power, and calibration checks should be performed annually by a
Cutera representative to ensure proper system performance.
System Repair
All system repairs should be performed by a Cutera-certified service engineer. For training and
information, contact Cutera Service (refer to Appendix C).
Routine User Maintenance
Clean the external surfaces of the system console Weekly, or as needed
Clean the system touchscreen display Weekly, or as needed
Inspect and clean the heat exchanger intake Inspect weekly; clean monthly, or as needed
Fill the coolant reservoir On installation or if water evaporates
Inspect and clean the handpiece During treatment, as needed, and between
patient use
Cleaning the External Surfaces of the System Console

Use a cloth dampened with non-caustic cleaning solution, such as mild soap and water, isopropyl
alcohol, or a “hospital-grade” disinfectant, to wipe the external surfaces of the system console. Dry with
a clean cloth, or allow to air dry.
WARNING
Do not attempt to gain access to any internal components. Electrical
shock and/or unintended laser exposure may result. Do not spray or
pour cleaning agents directly on the system console.
Cleaning the System Touchscreen Display

Apply an alcohol-based cleaner to a soft cloth to clean the system touchscreen display.
CAUTION
Do not spray or pour cleaning agents directly on the system console
or control screen. You may damage the console, touchscreen and
system electronics.

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Inspecting and Cleaning the Heat Exchanger Intake

The heat exchanger intake, located on the bottom of the system console, should be kept free of dust and
lint accumulation. If the heat exchanger intake becomes clogged, the system will overheat prematurely,
resulting in a temperature-related error code (i.e., E221, E224, or E229).
Inspect and clean the heat exchanger regularly using a hand mirror and long-handled bath brush as
described below.
1. Using a hand mirror, inspect the bottom of the system console for dust or lint
accumulation.
2. Clean the heat exchanger intake by inserting a long-handled bath brush under either side
of the system console, then pulling the brush toward your body to remove any dust or lint.
3. Repeat on the opposite side of the console to ensure that the entire heat exchanger intake
is clean.

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Filling the Coolant Reservoir

The system requires clean de-ionized or distilled water. Systems are delivered without any water in them
and must be filled with distilled water upon installation. Occasionally, distilled water may need to be
added to “top off” the system reservoir.
CAUTION
Permanent damage to internal components will occur if improper
coolant is used. One gallon of distilled water is shipped with every
system. Under no circumstances should ethylene glycol, tap water
or any liquid other than de-ionized or distilled water be used.
To completely fill the coolant reservoir in the system:
1. Turn off the system.
2. Open the reservoir door on the front of the system, and remove the reservoir fill cap.
Reservoir fill cap
Reservoir door
3. Carefully add water to the reservoir; do not overfill. Use only clean, unused distilled/de-
ionized water provided.
4. Turn the system keyswitch to the (start) position and release to the l (on) position. This
engages the water pump, allowing the coolant to be drawn into the cooling system.
5. Allow the system to run for 5 to 10 seconds.
7. Carefully top off the reservoir.
8. Repeat steps 4 thru 7 until the reservoir is full.

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9. Replace the fill cap, and close the reservoir door.
CAUTION
Ensure that the fill cap has a small hole to vent the system. A similar
fill cap without a vent hole is used to transport the system.
NOTE
The coolant capacity of the system is approximately one half gallon.
Inspecting and Cleaning the Handpiece

Inspect and clean the handpiece as described in the following sections. In addition to the external
surfaces of the handpiece, there are three optical surfaces that need to be maintained: the recessed lens
and the patient contact and proximal surfaces of the cooling window.
Recessed lens
Proximal surface
of cooling window
Patient contact surface
of cooling window

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Inspecting and Cleaning the External Surfaces of the Handpiece

Inspect and clean the handpiece housing, treatment guide and umbilical cable between patient use with
a germicidal disposable wipe, such as Sani-Cloth® Plus or Sani-Cloth® HB from Professional
Disposables International, Inc.1
WARNING
Before inspecting and cleaning the handpiece, ensure that the
system is either turned off or in STANDBY mode. Always wear
proper protective eyewear while the system is on. Severe eye
damage can occur in the event of unintended laser emission.
CAUTION
Do not allow liquid or cleaning solution to enter the handpiece
housing, as damage may occur.
CAUTION
Do not attempt to sterilize the handpiece. Damage will occur if the
handpiece is autoclaved, immersed or otherwise handled
improperly.
Inspecting and Cleaning the Handpiece Lens

The recessed handpiece lens is located at the distal end of the handpiece. Prior to treatment, as well as
periodically during treatment, inspect the lens for cracks and debris. If the handpiece lens is cracked or
otherwise damaged, do not use the handpiece. If the handpiece lens is dirty, clean as directed below.
WARNING
The system must be turned OFF or in STANDBY mode prior to
inspecting the lens. Do not inspect the lens while the system is in
READY mode. Always wear proper eyewear while the system is
ON. Severe eye damage can occur in the event of unintended laser
emission.
CAUTION
Inspecting and cleaning the handpiece lens is the responsibility of
the practitioner. If the lens is not properly maintained, debris can
build up on the surface of the lens, leading to permanent damage to
the lens and, ultimately, permanent damage to the handpiece
optical system. If debris cannot be removed from the lens, the
handpiece must be replaced.
1. Sani-Cloth Plus and Sani-Cloth HB are registered trademarks of Professional Disposables

International, Inc.

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CAUTION
Do not use germicidal disposable wipes to clean the recessed lens.
Doing so may damage the lens and require handpiece replacement.
NOTE
Debris from patients can accumulate on the lens. It may be
necessary to clean the lens periodically during treatment.
Clean the handpiece lens using a clean wood stick cotton swab and lens cleaning grade acetone, as
described below.
NOTE
For optimal results, use acetone with 0.5% or lower water content,
which is available at most camera shops. If unable to obtain acetone
with 0.5% or lower water content, contact Cutera Service (refer to
Appendix D).
NOTE
Use only wood stick cotton swabs. Do not use products such as Q-
Tips as they contain an adhesive that dissolves when it comes in
contact with acetone.
1. Ensure that the system is turned OFF or is in STANDBY mode.
2. Place a small amount of acetone on a wood stick cotton swab; if necessary, shake the
excess acetone off of the tip prior to cleaning the handpiece lens.
3. Gently wipe the surface of the lens.
Recessed lens

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4. Inspect the lens. If necessary, clean the lens again with a new cotton swab.
CAUTION
The lens must be clean before treating a patient. Chips, pits, cracks
or burned spots on the lens are not acceptable, and a handpiece
with these types of defects must be replaced.
Inspecting and Cleaning the Cooling Window

The cooling window has two optical surfaces that need to be maintained: the patient contact surface and
the proximal surface. Prior to treatment, as well as periodically during treatment, inspect both surfaces of
the cooling window for cracks and debris. If the cooling window is cracked or otherwise damaged, do not
use the handpiece. If the cooling window is dirty, clean as directed below.
WARNING
The system must be turned off or in STANDBY mode prior to
inspecting the cooling window. Do not inspect the window while the
system is in READY mode. Always wear proper eyewear while the
system is on. Severe eye damage can occur in the event of
unintended laser emission.
CAUTION
Inspecting and cleaning the cooling window is the responsibility of
the practitioner. If the cooling window is not properly maintained,
debris can build up on the surface of the window, leading to
permanent damage to the window. If debris cannot be removed
from the window, the handpiece must be replaced.
1. Ensure that the system is turned OFF or is in STANDBY mode.
2. Clean the patient contact surface of the cooling window, as follows:
Prior to treatment, clean the patient contact surface with a germicidal disposable wipe,
such as Sani-Cloth® Plus or Sani-Cloth® HB from Professional Disposables International,
Inc.
During treatment, clean the patient contact surface every 50 pulses, or as necessary, with
4x4 gauze if gel is used. If gel is not used, clean the patient contact surface every 5
pulses, or as necessary, with a cloth dampened with isopropyl alcohol or with a germicidal
disposable wipe.
NOTE
The patient contact surface has no optical coating; therefore,
aggressive scrubbing and cleaning of this surface is permitted.

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3. Clean the proximal surface of the cooling window, as follows:
Prior to treatment, clean the proximal surface of the cooling window with a germicidal
disposable wipe.
During treatment, keep the proximal surface of the cooling window clear of gel by gently
wiping periodically with 4x4 gauze. Excessive top side gel may affect laser beam output,
possibly leading to adverse events such as burns.
NOTE
The proximal surface of the cooling window has a delicate optical
coating; take care to not scratch this surface. Use a new germicidal
disposable wipe or 4x4 gauze, as applicable, each time the proximal
surface is cleaned.
Proximal surface
Patient contact
surface
4. Inspect the cooling window. If necessary, clean the window again.
CAUTION
The cooling window must be clean before treating a patient. Chips,
pits, cracks or burned spots on the window are not acceptable, and
a handpiece with these types of defects must be replaced.

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Remote Interlock Pin Assignments

To connect an external door switch to the remote interlock plug, you must purchase a replacement four
pin Mini DIN Plug and an external door switch. Connect the external door switch to the pin assignment
in the table below.
Pin Signal Name Signal Description
1 Return Connect to switch common
2 Remote Interlock Connect to Switch, Normally Open
3 None No Connection
4 None No Connection
3 4
1 2
Remote Interlock Pin Assignments (mating face shown)

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Electrical Utilities
The excel HR accepts mains power from 200-240 VAC. Power must be supplied from a dedicated
220±10% VAC, single-phase, 50/60 Hz source. The wiring should be rated for 30 amps (as per local
codes) “Hospital Grade” (NEMA L-20P or NEMA L-30P). Such a connection will ensure compliance with
allowable leakage current levels (<500 uA) per IEC 60601-1 for this device.
WARNING
To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
System Specifications
Specifications subject to change without notice.
Treatment Beam
Alexandrite High Power, Long Pulse

Type
Nd:YAG
Wavelength 755 nm 1064 nm
Fluence 4-100 J/cm2 3-300 J/cm2
Pulse Width 3 ms 0.1-300 ms
Repetition Rate  2 Hz and single shot
Delivery System Permanently attached umbilical and handpiece
5, 8, 10, 12, 14, 16 and 18 mm 3, 5, 7, 10, 12, 14, 15, 16 and

Treatment Spot
18 mm
Epidermal Cooling Full contact thermoelectric chiller
System Cooling Self-contained, water to air heat exchanger
Aiming Beam 635 nm

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Physical Parameters
Size (W X D X H): 13 in X 18 in X 38 in (.33 m X .46 m X .96 m)
Weight: 140 lbs (63.5 kg)
Operating length of umbilical: 6.5 ft (2 m)
Minimum bend radius of Storage 5 in (126 mm)

umbilical: Momentary 2 in (50 mm)
Electrical Requirements
Voltage, Current 200 - 240 V~, 30 A
Frequency 50/60 Hz
Environmental Requirements
Temperature Operating 5º C to 30º C
Non-operating -10º C to 50º C, coolant drained
Humidity 0 to 90%, non-condensing
Max. Heat Dissipation 4,000 Watts
Max. Altitude Operating 15,000 ft

Non-operating 50,000 ft
Atmospheric Pressure 20 to 110 kPa
Maximum Allowable Temperature of Accessible Parts
Parts User/Patient Can Touch Material Duration Limits

Enclosure Plastic > 1 min 48º C
Touchscreen Plastic > 1 min 48º C
Handpiece Window Sapphire > 1 min 20º C
Handpiece Treatment Guide Metal > 1 min 20º C
Classifications
FDA Classification Class II Medical Device
CDRH Classification Class IV Laser Product
European MDD 93/42/EEC

Laser Classification Class 4 Laser to IEC 60825-1:2014

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Type BF
Applied Part Handpiece
Eyewear Specifications
WARNING
Never look directly into the handpiece, even if appropriate safety
eyewear is being worn.
NOTE
For general information on the ocular hazards associated with the
excel HR, refer to the Safety and Regulatory chapter of this manual.
755 nm
Nominal Ocular Hazard Distance (NOHD) 200 m
Maximum Permissible Exposure (MPE) 2.81*10-4 W/cm2
Minimum Optical Density (OD) for Protective Eyewear 7
1064 nm
Nominal Ocular Hazard Distance (NOHD) 82 m
Maximum Permissible Exposure (MPE) 2.69*10-4 W/cm2
Minimum Optical Density (OD) for Protective Eyewear 6.2

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Calibration Procedure
Regulatory agencies require that manufacturers of US FDA CDRH Class III and IV and European EN
60825-1 Class 3 and 4 medical lasers supply their customers with power calibration instructions.
Calibration of the laser output should be checked periodically. With proper care under normal operating
conditions, Cutera recommends calibration every twelve (12) months to ensure that the energy output
delivered from the handpiece corresponds accurately to the user-selected settings. The following
procedure should also be performed after any service or repair work. Excessive vibration may
necessitate more frequent calibration.
DISCLAIMER WARNING
Calibration is a service procedure to be performed only by a Cutera-
certified Service Engineer or customers who have taken and passed a
Cutera Service Certification Training course. Adjustments by anyone
other than a trained Cutera Service Engineer or a certified customer
voids any existing manufacturer’s warranty on the instrument. A
service manual for your system may be purchased from the Cutera
Service Department. However, possession of service instructions or
service tooling does not authorize repair or modification of a Cutera
system by uncertified personnel.
Calibration must be performed by an engineer or technician certified to work on energized electronic

laser equipment. Questions regarding this procedure should be referred to Cutera Service (refer to
Appendix C).
Equipment Required
• Laser safety eyewear for all persons in the room (with appropriate optical densities at the
wavelengths being generated).
• Laser energy meter (Ophir Nova display unit model with L40-150A-SH sensor). The meter
used must have received a NIST-traceable calibration within the past 12 months (in the US)
or a calibration conforming to the applicable standard (internationally).
Calibration Instructions
1. Set up the laser energy meter in a convenient location so that the sensor head can be
easily reached with the handpiece. Set the meter display unit to the ENERGY mode.
2. Ensure that all personnel in the room are wearing the appropriate eyewear.
3. Connect the service computer to the serial port.
4. Start the system in service mode and using the Cutera Service software, place the system
in CALIBRATION mode.
5. Follow the prompts on the calibration screen.

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6. Place the system in User mode and verify the calibration using an external meter.
CAUTION
Any work performed by unauthorized personnel will void all
warranties.
Warranty Information
For specific and detailed warranty information for your system, please refer to the first page of your
purchase “Agreement” and the last page of the “Terms and Conditions of Sale”.
End of Life Disposal - Environmental Information

The system must be disposed of according to local laws and hospital practices. This product is
considered electronic equipment and must not be disposed of as unsorted municipal waste and must be
collected separately. Please contact the manufacturer or other authorized disposal company to
decommission your equipment.
Proper disposal of electronic equipment is required according to EU Directive 2002/96/EC Waste

Electrical and Electronic Equipment (WEEE).

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D1492, REV. E, 02/16
47
Safety and Regulatory

Introduction
Cutera lasers and handpieces, when properly used by trained personnel, are safe and effective
instruments for indicated clinical treatments. Keep in mind that safe operation requires a thorough
understanding of the system and safety features as described in this operator manual.
Users must take precautions to prevent exposure of laser energy to the eyes and skin from either direct
or diffusely reflected light, except as a therapeutic application. Additional precautions must be taken to
prevent fire, electrical injury and explosion.
Cutera does not make recommendations regarding the practice of medicine. Treatment parameters are
provided as a guide. Individual treatments should be based on clinical training, clinical observation of
laser-tissue interaction and appropriate clinical endpoints.
Optical Hazard
Safety eyewear is routinely required with most lasers. Personnel responsible for laser safety should
determine the need for safety eyewear based on the Maximum Permissible Exposure (MPE), Nominal
Hazard Zone (NHZ), the Nominal Ocular Hazard Distance (NOHD) and the optical density (OD) for the
755 nm and 1064 nm wavelengths and the configuration of the treatment room (usually within the
controlled area). For additional information, refer to ANSI Z136.3-2005, ANSI Z136.1-2007, or European
Standard EN 60825-1:2014, Annex A.
Cutera laser systems are Class IV Laser Products as defined by the U.S. Code of Federal Regulations
and Class 4 Lasers as defined by the European Communities Medical Device Directive.

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WARNING
The laser light produced by the excel HR is invisible infrared (755
nm and 1064 nm) light that can cause permanent eye damage.
Never look directly into the handpiece even when wearing
protective eyewear. Never look directly into the treatment beam or
at scattered light from metallic or other reflective surfaces. Both
direct and reflected laser light may contain sufficient energy to
cause permanent eye damage.
All personnel operating or in the vicinity of the excel HR, including the patient, staff personnel and
observers, should wear protective eyewear with sufficient protection (i.e., optical density specified in the
Eyewear Specifications section, or greater) for the 755 nm and 1064 nm wavelengths. The eyewear
should have guards on both sides to protect the eyes from lateral exposure.
WARNING
Never allow anyone without proper protective eyewear near the
system while in use.
Guidelines and information on the safe use of lasers, and the safe use of lasers/laser systems in
diagnostic and therapeutic areas, can be found in the following:
• The American National Standard for the Safe Use of lasers in Health Care Facilities (ANSI
Z136.3-2005).
• The American National Standard for Safe Use of Lasers (ANSI Z136.1-2007).
• European Standard EN 60825-1:2014, Annex A.
The ANSI and the European standards describe the following terms in the description of laser hazards:
• Maximum Permissible Exposure (MPE) - The highest level of laser radiation to which a
person may be exposed without hazardous effect or adverse biological changes in the eye
or skin.
• Nominal Ocular Hazard Distance (NOHD) - The distance along the axis of the
unobstructed beam beyond which exposure during normal operation is not expected to
exceed the appropriate MPE. This distance is measured from the laser aperture.
• Nominal Hazard Zone (NHZ) - The space within which the exposure level during normal
operation exceeds the applicable MPE. The outer limit of the NHZ is the NOHD.
For specific values, see the Eyewear Specifications section of this manual.
In addition to providing the required safety eyewear, take the following steps to secure the treatment
room or controlled treatment area:
1. To alert personnel before they enter the controlled area, place a warning sign on the
outside of the treatment room door when the laser is in use.

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2. Close the treatment room door during operation of the system.
3. External door interlocks that automatically disable the system when the treatment room
door is opened may be installed.
NOTE
A blocking barrier, screen or curtain capable of blocking or filtering
the treatment beam may be placed to create a controlled area
inside a large treatment room. The barrier should be made of
material that can withstand the power of the treatment beam for the
maximum exposure time, relative to the configuration of the
controlled area and the treatment parameters for the specific
medical application.
Depending on the procedure, the physician must protect the patient’s eyes with either laser safety
eyewear or with diffuse metal eye shields. Apply wet gauze over the eye lid when using metal eye
shields.
Additional Ocular Protection
WARNING
Never substitute non-laser prescription eyewear for the appropriate
laser safety eyewear, as severe damage could occur.
WARNING
Use caution when performing procedures around the eyes. Severe
and irreversible eye damage may occur from direct or indirect
exposure to treatment beams.
WARNING
Never look directly into any optical lens, optical fiber, handpiece or
system aperture while the system is energized. Severe eye damage
could occur. Turn off the system before inspecting any handpiece or
system component.

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Additional Safety Considerations
WARNING
Do not use this system in the presence of flammables or explosives
such as anesthetics, alcohol, surgical preparation solutions and
similar substances. An explosion and/or fire could occur.
WARNING
No modification of the excel HR system is allowed.
CAUTION
The excel HR is intended solely for licensed practitioners trained in
its proper use.
CAUTION
Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous laser radiation
exposure.
Protecting Non-Target Tissues
WARNING
Except during actual treatment, the system must always be in
STANDBY mode. Maintaining the system in STANDBY mode
prevents accidental treatment beam exposure if the footswitch is
inadvertently pressed.
WARNING
Never place hands or other objects in the path of the treatment
beam.
Electrical Hazard
WARNING
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
WARNING
High voltages are present inside the system. Do not remove the
exterior housing.

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WARNING
Only an authorized Cutera Service Representative should perform
the service on the system.
WARNING
Do not attempt to perform maintenance other than that which is
outlined in this manual.
WARNING
Maintenance should only be performed with the system turned off
and disconnected from the power source.
WARNING
The system is grounded through the grounding conductor in the
power cord. Grounding is essential for safe operation.
Fire Hazard
WARNING
Do not use this system in the presence of flammable materials,
solutions, or gases or in an oxygen-enriched environment. An
explosion and/or fire could occur.
WARNING
The high temperatures produced in normal use of the system may
ignite endogenous gases, as well as some materials (e.g., cotton
wool when saturated with oxygen). The solvents of adhesives and
flammable solutions used for cleaning and disinfecting should be
allowed to evaporate before the system is used.

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Operational Training
WARNING
Do not allow untrained or unqualified personnel to use the system at
any time.
CAUTION
US federal law restricts the sale of this device to or by the order of
a licensed practitioner licensed by the law of the state in which he
practices to use or order the use of the device; and the method of its
application or use.
CAUTION
Do not attempt to use this system until you have been properly
trained on system operation by certified personnel and have read
this manual thoroughly.
Refer to the Treatment Guidelines accompanying this operator manual and to the Cutera website for
available training options and resources. The Treatment Guidelines can also be obtained from your local
Cutera representative or on the Cutera website.
In addition to laser safety training of personnel, the user should consider adopting a training and safety
program as outlined by the latest ANSI Standard Z-136.3, the American National Standard for the Safe
Use of Lasers in Health Care Facilities or an equivalent European Union standard. The practitioner
should also keep current with all relevant medical literature.

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Operational Safety
WARNING
Laser plume may contain viable tissue particulates. The plume
presents a possible pollution hazard and should be effectively
evacuated. A commercial smoke evacuator designed for use with
aesthetic lasers may be used.
WARNING
Do not place any unnecessary stress on the umbilical cable (e.g., by
pulling on it, tightly bending it or twisting the handpiece). Doing so
may damage the cable and/or expose the patient or user to
hazardous laser radiation. See the System Specifications section
for additional information on the minimum bend radius for the
umbilical cable.
WARNING
The handpiece is a fragile instrument and must not be dropped. If it
is dropped, you must carefully examine the handpiece for any
physical damage prior to use.
WARNING
Never point the handpiece at reflective objects, such as jewelry or
smooth metal surfaces.
WARNING
Never activate the treatment beam while pointing the handpiece into
free space.
WARNING
Do not leave the system in READY mode when not in use. Always
place the system in STANDBY mode or turn off the system and
remove the key when not performing treatments.
WARNING
Do not leave the system unattended with the key in place.
CAUTION
Prior to each use of the system, inspect all protective eyewear,
cables and handpieces for any damage, excessive wear, or
crimping that could affect system performance or safe operation.

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CAUTION
Always verify that the treatment parameters are correct before
activating the system.
CAUTION
Before placing the system in READY mode, confirm that the laser
aperture on the handpiece is safely positioned to prevent
unintended treatment exposure.
CAUTION
The system should always be in the STANDBY mode until the
handpiece is safely positioned at the area to be treated.
NOTE
The recessed lens(es) and the cooling window on the handpiece
should be kept clean during and prior to each treatment procedure.
See the Maintenance section for recommended cleaning and
disinfecting procedures.

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Regulatory Compliance
All Cutera aesthetic platforms are designed to comply with the following:
• US Federal Performing Standards 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC 60601-
1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22 and IEC 60825-1
• 21 CFR Chapter I, Subchapter J, as administered by the Center for Device and

Radiological Health of the US Food and Drug Administration (FDA)
• European Communities Medical Device Directive 93/42/EEC
Location of Controls
Operation and adjustment controls are located so that the user need not be exposed to the treatment
beam during operation or adjustment.
Key Lock Switch

To prevent unauthorized use, the system can only be turned on with the proper key. The key cannot be
removed while in the l (on) or (start) position, and the system will only operate with the key in place.
When the system is not in use, always remove and store the key.
Emergency Off Button

The system can be immediately shut down, terminating laser emission, by pushing the red emergency off
button that is located next to the keyswitch. Following emergency shutoff, the keyswitch must be used to
restart the system.
Laser Emission Indicator

The treatment beam can only be delivered when the system is in READY mode and the READY icon is
highlighted on the touchscreen display. When the footswitch is pressed and the treatment beam is being
delivered, the system emits an audible tone, and a yellow indicator next to the READY button illuminates
to indicate treatment beam emission.
Remote Interlock
A remote interlock connector on the back panel, when used in conjunction with an external switch
connected to the treatment room door, will shut the system down if the treatment room door is opened.

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Protective Housing
The system console has protective housings that prevent unintended human access to laser radiation
above Class I limits. The housing must be opened only by a Cutera-certified representative.
NOTE
No section of the protective system housing can be opened without
special tools.
Laser Safety Shutter

The system console contains a “normally closed” safety shutter that prevents treatment beam emission
when in the closed position. The shutter is opened only when the system is in the READY mode.
Audible Emission Indicator

Each treatment beam exposure is accompanied by an audible tone. In addition, a distinctive “water drop”
sound is emitted each time the pulse counter reaches a count that ends in “00” in order to indicate the
delivery of 100 shot increments.
Manual Reset
If the system shuts down during operation (e.g., due to electrical power loss, depression of the
emergency off button or opening of the door interlock switch), the system must be manually restarted
using the key switch to resume operation. The system internal memory will recall the most recent
operating parameters upon restart.
Electronic Fault Detection Circuitry

If the electronic system detects a fault condition, treatment beam exposure cannot occur. The high
voltage power supply is turned off, the high voltage capacitor is discharged, the safety shutter is closed
and the footswitch is disabled.
Some fault conditions may be cleared by the operator. Refer to the Troubleshooting Guide in this manual
for additional information.

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Location of Regulatory Compliance Labels

As required by national and international regulatory agencies, appropriate regulatory compliance labels
have been mounted in specified locations. All treatment room staff should be familiar with the location
and meaning of these labels.
Location of Regulatory Compliance Labels on System Console and Handpiece

(Refer to the following pages for label illustrations and Appendix B for symbol descriptions.)

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Regulatory Compliance Labels
REF EXCELHR INVISIBLE AND VISIBLE LASER RADIATION

SN EH12345 AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
Mmmmm Yyyy
Output: 60 J Max at 755 nm
Brisbane, CA 100 J Max at 1064 nm
200-240 V~, 30 A, 50/60 Hz Duration: 3 ms at 755 nm
0.1-300 ms at 1064 nm
Class 4 Laser Product
Per IEC 60825-1:2014
0044 Aim Beam: ≤ 1 mW Max at 635 nm, Class 2
Complies with 21 CFR 1040.10 and 1040.11

except for deviations pursuant to Laser Certification
Notice No. 50, dated June 24, 2007 label
30°C
5°C
3240 Bayshore Blvd.

Brisbane CA 94005, USA
excel HR Identification Label

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Emergency Stop Button Non-interlock Housing Label Tilting Hazard Label

Located on top of console Located at lower corner on each Located on sides of system console
(next to red button) side of console (Warning of tilting hazard. Do not push
console over obstacle >10 mm in height.
Doing so may cause user injury.)
System OFF System ON Momentary Start

Located next to keyswitch Located next to keyswitch Located next to keyswitch
OR
Laser Radiation Warning

Located on handpiece
(Warning of laser radiation from adjacent aperture)

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Electromagnetic Compatibility
The excel HR laser system design complies with IEC 60601-1-2 (3rd edition) requirements for electro-
magnetic compatibility (EMC) with other devices. Like other electrical medical equipment, the excel HR
requires special precautions to ensure EMC with other electrical medical devices and must be installed
and operated according to the EMC information provided in this manual.
CAUTION
Portable and mobile RF communications equipment may affect the
normal function of the excel HR.
WARNING
Do not use cables or accessories other than those provided with the
excel HR laser system, as this may result in increased
electromagnetic emissions or decreased immunity to such
emissions.
WARNING
If the excel HR laser system is used adjacent to or stacked with
other equipment, observe and verify normal operation of the excel
HR in the configuration in which it will be used prior to using it in a
surgical procedure. Consult the tables below for guidance in placing
the excel HR.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The excel HR is intended for use in the electromagnetic environment specified below. The customer or
the user of the excel HR should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment: Guidance
RF emissions CISPR 11 Group 1 excel HR laser systems use RF energy only for
internal function; therefore, RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11 Class B excel HR laser systems are suitable for use in all
establishments, including domestic
Harmonic emissions Class A establishments and those directly connected to
IEC61000-3-2 the public low voltage power supply network that
supplies buildings used for domestic purposes.
Voltage Fluctuations/flicker Complies
emissions IEC61000-3-3

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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The excel HR is intended for use in the electromagnetic environment specified below. The customer or the user of
the excel HR should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance
Electrostatic ±6kV contact ±2, 4, 6kV contact Floor should be wood, concrete, or ceramic
Discharge (ESD) tile. If floors are covered with synthetic
±8kV air ±2, 4, 8kV air material, the relative humidity should be at
IEC61000-4-2 least 30%.
Electrical fast ±2kV for power ±2kV line to ground Mains power quality should be that of a
transient/burst supply lines typical commercial or hospital environment.
±1kV line to line
IEC61000-4-4 ±1kV for input/output
lines
Surge ±1kV differential ±0.5, 1kV Mains power quality should be that of a
mode typical commercial or hospital environment.
IEC61000-4-5 differential mode
±2kV common mode
±0.5, 1, 2kV
common mode
Voltage dips, <5% Ut (>95% dip in <5% Ut (95% dip in Mains power quality should be that of a
short interruptions Ut) for 0.5 cycle Ut) for 0.5 cycle typical commercial or hospital environment.
and voltage If the user of the excel HR requires
variations on 40% Ut (60% dip in 40% Ut (60% dip in continued operation during power mains
power supply Ut) for 5 cycles Ut) for 5 cycles interruptions, it is recommended that the
input lines system console be powered from an
70% Ut (30% dip in 70% Ut (30% dip in uninterruptible power supply or a battery.
IEC61000-4-11 Ut) for 25 cycles Ut) for 25 cycles
<5% Ut (>95% dip in <5% Ut (>95% dip in

Ut) for 5 sec. Ut) for 5 sec.
Power frequency 3 A/m N/A Power-frequency magnetic fields should be

(50/60Hz) at levels characteristics of a typical location
magnetic field in a typical commercial or hospital
environment.
IEC 61000-4-8
NOTE: Ut is the a.c. mains voltage prior to application of the test level.

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Guidance and Manufacturer’s Declaration: Electromagnetic immunity
The excel HR is intended for use in the electromagnetic environment specified below. The customer or
the user of the excel HR should ensure that it is used in such an environment.
Immunity Test IEC 60601 Compliance Electromagnetic Environment: Guidance

Test Level Level
Portable and mobile RF communications

equipment should be used no closer to any
part of the system console, including its
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended Separation Distance

d = 1.17 √P
Conducted RF 3 Vrms 3V d = 1.17 √P 80MHz to 800MHz
IEC 61000-4-6 150kHz to d = 2.33 √P 800MHz to 2.5GHz
80 MHz
Radiated RF where P is the maximum output power rating
IEC 61000-4-3 3V/m 3 V/m of the transmitter in watts (W) according to
80MHz to the transmitter manufacturer and d is the
2.5 GHz recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site
survey(a), should be less than the compliance
level in each frequency range(b).
Interference may occur in the vicinity of

equipment marked with the following symbol:
NOTE: 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobiles radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered,. If the measured field strength in the
location in which the excel HR laser system is used exceeds the applicable RF compliance level above,
the system should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the system console.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the System Console
The excel HR is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or user of the excel HR can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the
system console as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output Separation distance (m) according to frequency of transmitter

power (W) of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.17 √P d = 1.17 √P d= 2.33 √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d)
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

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Clinical Applications
General Indications for Use
The excel HR is intended for use in surgical and aesthetic applications in the medical specialties of
dermatology and general and plastic surgery.
755 nm Alexandrite Indications

The 755 nm wavelength is indicated for temporary and permanent hair reduction on all skin types
(Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable
reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The 755 nm wavelength is also indicated for:
• treatment of benign pigmented lesions
• treatment of wrinkles
• photocoagulation of dermatological vascular lesions such as, but not limited to, port wine
stains, hemangiomas and telangiectasias
1064 nm Nd:YAG Indications

The 1064 nm wavelength is intended for the coagulation and hemostasis of benign vascular lesions such
as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg
veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as, but
not limited to, warts, scars, striae and psoriasis. The lasers are also intended for the treatment of benign
pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait
macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant
reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the 1064 nm wavelength is indicated for benign pigmented lesions to reduce lesion size, for
patients with lesions that would potentially benefit from aggressive treatment, and for patients with
lesions that have not responded to other laser treatments.

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The 1064 nm wavelength is also indicated for the treatment of wrinkles such as, but not limited to,
periocular and perioral wrinkles.
The 1064 nm wavelength is indicated for temporary and permanent hair reduction. Permanent hair
reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after
the end of a treatment regime.
The 1064 nm wavelength is also indicated for the treatment for pseudofolliculitis barbae (PFB).
The 1064 nm wavelength is also indicated for the reduction of red pigmentation in hypertrophic and
keloid scars where vascularity is an integral part of the scar.
The 1064 nm wavelength is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the laser handpiece is to provide cooling of the skin
prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher
fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side
effects of laser treatments.
Surgical Applications
The 1064 nm wavelength is indicated for the incision/excision and cutting, ablation, coagulation/
hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy,
gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery,
oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia)
and urology.

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Contraindications for Use

Contraindications for use:
• Pregnant patients
• Patients undergoing treatment for skin cancer
Warnings
• Do not treat over dysplastic nevi or questionable pigmented lesions.
• Do not treat over or close to tattoos or permanent make-up.
• Hair removal by lasers can cause increased hair growth in some individuals. Based upon
currently available data, the highest risk groups for this response are females of
Mediterranean, Middle Eastern and South Asian heritage treated on the face and neck.
Precautions
• Photosensitizing drugs (Tetracyclines, etc.)
• Anticoagulants - may increase risk of purpura or bruising
• History of coagulopathies
• History of keloids or hypertrophic scarring
• Diabetes - may impede wound healing
• History of herpes - pre-treatment with an antiviral may be indicated
• Isotretinoin (Accutane) use within the previous 6 months
• History of vitiligo

D1492, REV. E, 02/16
68
Expected Transient Events and Possible Adverse Effects

• Erythema, edema and purpura may occur following treatment and typically resolve with
time.
• Hyperpigmentation, hypopigmentation, burns, erosion, epidermal crusting or blistering may

occur, some of which may result in scarring.
• Temporary or permanent gray hair (leukotrichia) may develop.
• Stimulation of terminal hair growth may occur within or adjacent to treated area.
• Undesired hair loss in hair-bearing areas may result from treament of vascular and benign
pigmented lesions.
• Sun exposure/tanning beds/artificial tanning may increase the risk of unwanted side effects
and adverse events.
• Red rash/bumps
• Hemosiderin staining
• Textural changes/cutaneous indentations
Treatment Precautions
The excel HR should only be operated by qualified personnel who have received appropriate training. In
addition to the information provided in the Safety and Regulatory section of this manual, the following
safety precautions are recommended:
• Guard against accidental exposure to laser energy.
• Instruct all staff members to carefully aim the treatment beam only at the targeted treatment
areas.
• Ensure that the patient and all staff personnel in the treatment room wear appropriate
protective eyewear. If the patient cannot wear protective eyewear, fit the patient with opaque
eye protection that will completely block light to the eyes. The eyewear must provide
adequate protection from laser radiation of the wavelength being used. See the Eye Safety
section in the Maintenance chapter for protective eyewear requirements.
• Instruct all staff members and patients to never look directly at the laser light or reflective
surfaces, even when wearing proper protective eyewear.
WARNING
Never allow anyone near the system while the system is in use
without proper protective eyewear. Unprotected laser exposure can
cause permanent eye damage.

D1492, REV. E, 02/16
69
Treatments
The excel HR can be used to remove hair, to treat benign pigmented and vascular lesions, and to treat
wrinkles.Perform and observe test spots prior to treatment. Potential adverse reactions may take 24-72
hours to appear. Pigmentation changes for darker skin type patients may develop up to several weeks
following treatment.
• Test spot fluence settings are determined by evaluating skin type and, for hair removal
procedures, hair color, thickness and density.
• Treatment settings should be selected based on test spot clinical response.
• Perform test spots on the same area as being treated.
• Deliver single pulses to assess clinical response and potential adverse reactions.
• Deliver 3 to 4 adjacent pulses to assess skin's reaction to bulk heating.
When used for hair removal, 755 nm and 1064 nm laser energy is selectively absorbed by melanin in the
hair follicle and shaft, resulting in selective destruction of the hair structure without damaging the
epidermis or surrounding tissue. Because the laser energy is absorbed by melanin in the epidermis, as
well as by the desired target structures, the epidermal-cooling feature integrated in the handpiece is used
to reduce the temperature rise in the epidermis.
When treating benign pigmented lesions, the excel HR specifically targets the superficial pigment in the
epidermis. In choosing the wavelength spectrum with strong melanin absorption and low hemoglobin
absorption, lower fluences are needed for effective treatment.
When treating vascular lesions, the blood temperature at the targeted area is elevated to a level that
causes coagulation without damage to the epidermis or surrounding tissue. Since 755 nm and 1064 nm
laser energy is absorbed by melanin in the epidermis, as well as the desired target of hemoglobin, the
epidermal-cooling feature integrated in the handpiece is used to reduce the temperature rise in the
epidermis. Multiple treatments may be necessary to obtain a satisfactory response.
The excel HR gives the user the flexibility to adjust key parameters. Pulse width and fluence parameters
can be adjusted based on target size, skin type and tan, if present.
It is recommended that the clinical user begin with a low fluence and observe the epidermal response
before increasing the fluence. Increasing the fluence may provide increased efficacy, however factors
such as skin type and tanning may limit the maximum usable fluence without unwanted epidermal
damage.
For recommended treatment settings, please refer to the Treatment Guidelines accompanying this
operator manual.

D1492, REV. E, 02/16
70
Patient Information
Prior to treatment, the user should conduct a patient consultation. The consultation should include a
complete medical history and exam. At that time, the user should also discuss all potential benefits,
complications, options and risks of treatment.

D1492, REV. E, 02/16
A-1
Appendix A - Laser Warning Sign
excel HR Laser Warning Sign

D1492, REV. E, 02/16
A-2
THIS PAGE IS BLANK

D1492, REV. E, 02/16
B-1
Appendix B - Symbols
This appendix describes the laser system symbols and their meanings.
Standard
Symbol Description Location
Reference
Cutera logo Control panel
417-5007 Mains ON Rear panel (at circuit breaker) and

control panel (next to keyswitch)
417-5008 Mains OFF Rear panel (at circuit breaker) and

control panel (next to keyswitch)
417-5104 Momentary start Control panel (next to keyswitch)
DIN 18734 Emergency OFF Control panel (next to red button)
417-5266 Standby Touchscreen display
417-5264 Ready Touchscreen display
Cutera-defined Fluence (J/cm2) Touchscreen display
Cutera-defined Pulse width (ms) Touchscreen display
Cutera-defined Repetition rate (Hz) Touchscreen display

D1492, REV. E, 02/16
B-2
Standard
Reference
Cutera-defined Laser emission indicator Touchscreen display
Cutera-defined Aiming beam adjustment Touchscreen display
Cutera-defined Temperature of sapphire cooling Touchscreen display

window
Cutera-defined Save/recall settings in memory Touchscreen display

store
Cutera-defined Pulse counter reset Touchscreen display
Cutera-defined Spot size Touchscreen display
Cutera-defined Go to Information & Adjustment Touchscreen display

screen
Cutera-defined Return to previous screen Touchscreen display
Cutera-defined Volume of audible tones and Touchscreen display

indicators
Cutera-defined Touchscreen backlighting Touchscreen display
Cutera-defined System controller software Touchscreen display

version
Cutera-defined Handpiece software version Touchscreen display
Cutera-defined System display software version Touchscreen display

D1492, REV. E, 02/16
B-3
Standard
Reference
Cutera-defined Footswitch receptacle Rear panel label
IEC 60825-1 Remote interlock connector (as Rear panel label

defined in 3.67 of IEC 825-1)
BS EN ISO Model number Rear panel label

REF 15223-1
BS EN ISO Serial number Rear panel label

SN 15223-1
BS EN ISO Date of manufacture Rear panel label

15223-1
BS EN ISO Manufacturer Rear panel label

15223-1
BS EN ISO Authorized representative in the Rear panel label

15223-1 European Community
MDD 93/42/EEC CE Mark Rear panel label
TUVus Mark Rear panel label
IEC 60601-1 Operating temperature range Rear panel label
IEC 60601-1 Consult accompanying Rear panel label

documents
WEEE Directive Waste of electrical and electronic Rear panel label

equipment must not be disposed
as unsorted municipal waste and
must be collected separately.

D1492, REV. E, 02/16
B-4
Standard
Reference
IEC 60601-1 Type BF equipment Rear panel label
IEC 60825-1 Laser radiation warning Rear panel label and near laser
aperture on handpiece
IEC 60825-1 Laser aperture Near laser aperture on handpiece
IEC 60601-1 Tilting hazard—do not push Side panels

console over obstacle >10mm
in height

D1492, REV. E, 02/16
C-1
Appendix C - Cutera Direct Office Locations

Cutera World Headquarters
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005
Telephone: (888) 4-CUTERA (within US) or (415) 657-5500 (outside US)
Service: (866) 258-8763 (within US) or (415) 657-5500 (outside US)
Fax: (415) 330-2444
Cutera (Japan)
Cutera K.K.
Shibuya Infoss Annex Bldg, 3rd fl.
12-10 Sakuragaoka
Shibuya-ku, Tokyo 150-0031
Tel: +81 (0) 3 5456 6325
Fax: +81 (0) 3 5456 2213
Cutera (Europe)
Cutera France
1 rue Georges Charpak
Bât C
77127 LIEUSAINT
Tel: +33 (0) 1 60 62 24 40
Fax: +33 (0) 1 60 34 31 75

D1492, REV. E, 02/16
C-2
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D1492, REV. E, 02/16

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What are the main components of the laser system?

What are the main components of the laser system?

How should the system components be connected?

How should the system components be connected?

Operator Manual

Cutera is the registered trademark of Cutera, Inc.

©February 2016 Cutera, Inc.

EXCEL HR OPERATOR MANUAL

EXCEL HR OPERATOR MANUAL

Disconnecting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

EXCEL HR OPERATOR MANUAL

Remote Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

EXCEL HR OPERATOR MANUAL

Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

General Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

APPENDIX A - LASER WARNING SIGN

APPENDIX C - CUTERA DIRECT OFFICE LOCATIONS

EXCEL HR OPERATOR MANUAL

Characteristics of the 755 nm Alexandrite Laser Beam

EXCEL HR OPERATOR MANUAL

Characteristics of the 1064 nm Nd:YAG Laser Beam

Verifying the Integrity of the Delivery System

EXCEL HR OPERATOR MANUAL

Remote Interlock Plug

EXCEL HR OPERATOR MANUAL

Remote interlock plug

System console Footswitch

EXCEL HR OPERATOR MANUAL

Connecting the System Components

Connecting the Footswitch

Inserting the Remote Interlock Plug

EXCEL HR OPERATOR MANUAL

Connecting the Main Power Cable

EXCEL HR OPERATOR MANUAL

Restarting the System

1. Turn the keyswitch to the O (off) position.

Turning Off the System

EXCEL HR OPERATOR MANUAL

Emergency off button

Disconnecting the System

5. Store the handpiece in the compartment at the front of the console.

EXCEL HR OPERATOR MANUAL

Moving the System

1. Disconnect the system and store the handpiece as described above.

3. Unlock the console wheels by disengaging the wheel locks.

5. Lock the console wheels by engaging each wheel lock.

EXCEL HR OPERATOR MANUAL

Display Screens and Controls

Touch to select 755 nm Touch to select 1064 nm

EXCEL HR OPERATOR MANUAL

• go to the Select screen (refer to the Select Screen topic)

Pulse width display

Go to Select Screen Go to Information &

Fluence display and Repetition rate

STANDBY button READY button

Temperature display Spot size display

755 nm Treatment Screen (STANDBY mode shown)