I

Operator Manual
ii

This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole
or in part or reproduced in any other media without the express written permission of Cutera, Inc. Permitted copies
must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying
includes translations into another language.

Please note that while every effort has been made to ensure that the data given in this document is accurate, the
information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change
without notice.

Cutera is the registered trademark of Cutera, Inc.

©February 2019 Cutera, Inc.

Published in USA
D2325
Revision A

Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA

MDSS GmbH
Schiffgraben 41, D-30175
Hannover, Germany

Australian Sponsor
Cutera Australia, Pty. Ltd.
PO Box 774
Maroubra, NSW 2035
 iii

Contents
CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III

OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Characteristics of the 532 nm Laser Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Characteristics of the 1064 nm Laser Beam . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
excel V+ System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Connecting the System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Inserting the Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Handpiece Dummy Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connecting the Main Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

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

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Genesis V Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Selecting the Laser Wavelength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Selecting the Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Selecting the Pulse Duration (532 nm only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Selecting the Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Dermastat Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Selecting the Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Selecting the Pulse Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Selecting the Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
System Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Routine User Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . 57
Cleaning the System Touchscreen Display. . . . . . . . . . . . . . . . . . . . . . . . . . 57
Inspecting and Cleaning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Inspecting and Cleaning the External Surfaces of the Handpiece . . . . . . . . . . . . . . . . . . 59
Inspecting and Cleaning the Handpiece Lens(es) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Inspecting and Cleaning the CoolView Handpiece Window . . . . . . . . . . . . . . . . . . . . . . . 62

Inspecting and Cleaning the Heat Exchanger Intake . . . . . . . . . . . . . . . . . . 64

Filling the Coolant Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Remote Interlock Pin Assignments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Systems Designed for Use Outside of Europe . . . . . . . . . . . . . . . . . . . . . . . 67
Systems Designed for Use in European Communities Under MDD . . . . . . . 67
Removable or Lockable Wall Socket and Plug Configurations . . . . . . . . . . . 67
Systems Designed for Use in European Communities Under MDD. . . . . . . . . . . . . . . . . 67

System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

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Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Maximum Allowable Temperature of Accessible Parts . . . . . . . . . . . . . . . . . 69
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Eye Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Calibration Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . 72
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Additional Ocular Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Electrical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Emergency Off Push-Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Laser Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

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Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Regulatory Compliance Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
System Console Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Handpiece Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
General Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
532 nm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
1064 nm Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Expected Transient Events and Possible Adverse Effects . . . . . . . . . . . . . . . . . . 93
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Treatment Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

APPENDIX A - LASER WARNING SIGN

APPENDIX B - SYMBOLS

APPENDIX C - BIBLIOGRAPHY

APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS

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Operation
Introduction
The Cutera excel V+ is a dual-wavelength (532 and 1064 nm) laser system that treats a wide range of
dermatologic conditions. Various laser pulse fluence, spot size, and pulse duration parameter
combinations can be used to treat unwanted veins, benign vascular lesions and birthmarks, and benign
pigmented lesions.

The excel V+ is a precision medical instrument. It has undergone extensive testing and with proper
handling is a useful and reliable clinical instrument. If you have any questions regarding your system,
contact your local Cutera representative.

WARNING
Any laser device can generate highly concentrated light which may
cause injury if improperly used. To protect patients and operating
personnel, the entire system operator manual, including the Safety
and Regulatory sections, should be carefully read and
comprehended before operation.

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Characteristics of the 532 nm Laser Beam

The 532 nm laser wavelength falls in the visible region of the electromagnetic spectrum and produces
green light. The 532 nm laser light is absorbed by hemoglobin and melanin in target tissues. This makes
the 532 nm laser useful for treating multiple indications. See the Clinical Applications section for specific
Indications for Use for the 532 nm wavelength.

Characteristics of the 1064 nm Laser Beam

The 1064 nm laser wavelength falls in the near infrared region of the electromagnetic spectrum. This
wavelength is invisible to the human eye; therefore, a low power, visible aiming beam that is coaxial with
the invisible treatment beam is used to target tissue. The 1064 nm laser light is a longer penetrating
wavelength that is absorbed by melanin and hemoglobin in target tissues. This makes the 1064 nm laser
useful for treating multiple indications. See the Clinical Applications section for specific Indications for
Use for the 1064 nm wavelength.

System Preparation
The excel V+ system is shipped directly from the factory to your site. Your local Cutera representative will
initially uncrate, inspect, set up, and install the system to ensure that it is working properly before use. In
addition, Cutera provides training to ensure that your staff is experienced with appropriate performance
and safety considerations. Thereafter, you or the staff at your facility will be performing the daily
maintenance routines associated with the system, as well as performing basic system safety checks.
These procedures are detailed later in this chapter and in the Maintenance section of this manual.

We recommend that you or your staff inspect and perform a functional system check prior to scheduled
cases. Doing so will ensure adequate time to troubleshoot problems or contact your service
representative with the least amount of disruption to patients and schedules.

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excel V+ System Components

The excel V+ consists of a system console with a boom and handpiece holster(s), handpiece(s), and a
footswitch. Other components necessary for operation, such as remote interlock plug and all electrical
cables, are also included.

System Console
The system console houses the touchscreen control panel, main power keyswitch, emergency off switch,
control electronics, laser source with associated optics, and power supply. The touchscreen control panel
allows you to select treatment settings.

Handpieces
The laser handpiece delivers laser energy from the system console to the treatment site. Three
ergonomically designed handpieces are available for use with the excel V+: CoolView, Genesis V, and
Dermastat.

The CoolView handpiece features integrated motorized zoom and epidermal cooling. The motorized
zoom feature enables you to adjust the laser spot size. The epidermal cooling feature allows you to
adjust the temperature of the sapphire cooling window to increase safety and efficacy.

The Genesis V handpiece features an integrated temperature sensor and LED temperature indicators,
which enable thermal monitoring of the target tissue. A working distance beam ensures proper
positioning of the handpiece when centered within the aiming beam.

The Dermastat is a pen-like handpiece for treating small areas with the 532 nm wavelength. An optional
standoff tip can be attached to the Dermastat to facilitate proper positioning of the handpiece at the
optimal working distance.

Footswitch
The footswitch activates the laser treatment beam.

Remote Interlock Plug

The system is equipped with a remote interlock plug which, when wired to an external door switch, shuts
down the system power if the treatment room door is opened or the interlock plug is removed.

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Boom

CoolView Handpiece

Holsters

Genesis V Handpiece

Dermastat Handpiece Optional Standoff Tip

Footswitch

System console

Remote interlock plug

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Connecting the System Components

Before connecting the excel V+ 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 section of this operator manual.

WARNING
Always turn the system OFF before inspecting the handpiece.
Never look directly into the handpiece even when wearing
protective eyewear. Never look directly into the laser beam or at
scattered light from metallic or other reflective surfaces. The 532 nm
and 1064 nm laser beams can cause permanent eye damage.

NOTE
Do not touch the recessed handpiece window; finger oils may
damage the coating.

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 will be displayed 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.

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Footswitch

Remote Interlock Plug

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Connecting the Handpiece

Connect the desired handpiece to the system console, as follows:

1. Align the handpiece connector over the handpiece receptacle on the side of the system
console, and press down gently to align the fittings. (CoolView and Genesis V handpieces
only)

2. Once aligned, press down firmly until you hear two audible clicks, indicating that both
locking tabs are engaged. (CoolView and Genesis V handpieces only)

NOTE
It is important to listen for two clicks when installing the CoolView
and Genesis V handpieces. The handpiece is properly connected
only when both locking tabs are engaged.

3. Remove the protective cap from the fiber connector.

4. Insert the fiber connector into the fiber receptacle on the side of the system console,
ensuring that the alignment guide on the fiber connector lines up with the alignment guide
above the fiber receptacle.

5. Lock the fiber connector in place by gently pushing the fiber connector into the receptacle
and then turning clockwise toward the icon.

Fiber receptacle

Fiber connector
Handpiece
connector

Locking tabs

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Connecting the Handpiece Dummy Plug

The excel V+ system console has two handpiece receptacles. If only one handpiece is installed, you
must insert a “dummy plug” into the vacant handpiece receptacle, as follows:

1. Align the dummy plug over the handpiece receptacle on the side of the system console
and press down gently to align the fittings.

2. Once aligned, press down firmly until you hear two audible clicks The clicks indicate that
both locking tabs are engaged.

NOTE
It is important to listen for two clicks when installing the dummy plug.
The dummy plug is properly connected only when both locking tabs
are engaged.

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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 receptacle end of the power cable into the power cable receptacle on the system
and insert the AC plug into the AC wall socket.

3. Insert the mains power cord plug into the appropriate wall socket and turn the main
electrical service ON. Ensure that the main power circuit breaker is in the up (ON) position.

Power cable wrap

Main power circuit breaker

Power cable receptacle

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System Basics
Turning On the System

Insert the key in the keyswitch, turn to the (START) position, hold for a full second, 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 two minutes, the system emits an audible tone, and the touchscreen displays the
CoolView Select Screen, the Genesis V Treatment Screen, or the Dermastat Treatment Screen,
depending on which handpiece is connected to the system console. 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 operator manual.

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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.

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

Emergency OFF Button

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Disconnecting the Handpiece Fiber Connector

To remove the handpiece fiber connector from the fiber receptacle:

1. Unlock the handpiece fiber connector by gently pushing the connector into the fiber
receptacle and then turning counter-clockwise.

2. Remove the fiber connector from the fiber receptacle and replace the protective cap onto
the fiber connector.

Disconnecting the Handpiece Connector or Dummy Plug

To remove the handpiece connector or dummy plug from the handpiece receptacle:

1. Press down on the front locking tab to release the handpiece connector or dummy plug.

2. Press down and hold the rear locking tab, and gently pull up on the handpiece connector
or dummy plug.

Handpiece
connector

Rear locking tab

Front locking
tab

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Disconnecting the System

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

2. Set the main circuit breaker to the OFF position.

3. Remove the power plug from the electrical outlet and wrap the power cable around the
cable wrap.

4. Place the footswitch on the footswitch storage mount on the rear of the laser console. Coil
the footswitch cable and store it inside the footswitch holder. Do not wrap the footswitch
cable around the power cable wrap.

Moving the System

1. Disconnect the system as described above.

CAUTION
Always disconnect the system as described above when moving the
system any distance other than within one room. The handpiece(s)
may be dislodged from the holster(s) when the system is moved
over thresholds or uneven surfaces. Damage will occur to the
handpiece(s) if dropped.

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.

2. Replace the vented filler cap with a sealed filler cap to prevent water from leaking.

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 the umbilical.

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

Wheel locks

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General System Functions

CoolView Handpiece User Interface Modes
excel V+ features two user interface modes for use with the CoolView handpiece: expert and navigation.
Expert mode is intended for advanced users with experience selecting the appropriate treatment
parameters for various skin types and applications. Navigation mode is intended for users who prefer
more guidance in selecting the appropriate treatment parameters.

In expert mode, you manually select parameters from a wide range of available settings on the CoolView
Treatment Screen. In navigation mode, you first select the patient’s skin type and the intended
application, and the recommended range of settings displays on the CoolView Treatment Screen. You
then select parameters from the recommended range of settings.

DISCLAIMER
Operating in navigation interface mode does not replace proper
training. Refer to this operator manual, as well as to the Treatment
Guidelines, for more information on parameter selection and proper
usage.

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CoolView Select Screen

When the CoolView handpiece is connected to the console fiber receptacle, the CoolView Select Screen
displays after the successful completion of the self-test routine at system start-up.

CoolView Select Screen

To operate in navigation mode, press the “Tap here to Select 532nm Application” or “Tap here to Select
1064nm Application” button. Otherwise, press the “Tap here to Set Parameters” button to operate in
expert mode. Refer to Selecting Treatment Parameters in Navigation Mode or Selecting Treatment
Parameters in Expert Mode later in this chapter for detailed information on selecting treatment
parameters.

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CoolView Treatment Screen

After pressing the “Tap here to Set Parameters” button on the CoolView Select Screen, the CoolView
Treatment Screen displays:

CoolView Treatment Screen in Expert Mode

After pressing the “Tap here to Select 532nm Application” or “Tap here to Select 1064nm Application”
button on the CoolView Select Screen, the CoolView Treatment Screen displays with the Skin Type
menu open:

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CoolView Treatment Screen in Navigation Mode

From the CoolView Treatment Screen, you can:

• select the skin type, treatment category, and treatment subcategory (navigation mode only;
refer to the Selecting Treatment Parameters in Navigation Mode topic)
• select the wavelength (refer to the User-selectable Parameters topic)
• select the fluence, pulse duration, and repetition rate (refer to the User-selectable
Parameters topic)
• make coarse adjustments to the laser spot size (refer to the User-selectable Parameters
topic)
• adjust the temperature of the sapphire cooling window (refer to the User-selectable
Parameters topic)
• view the actual temperature of the sapphire cooling window (refer to the User-selectable
Parameters topic)
• store and recall frequently used treatment parameters (refer to the Memory Storage topic)
• select the system status (refer to the System Status: STANDBY and READY Modes topic)
• view and reset the pulse counter (refer to the Displays and Indicators topic)
• go to the Information & Adjustment Screen (refer to Information & Adjustment Screen topic)

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Genesis V Treatment Screen

When the Genesis V handpiece is connected to the console fiber receptacle, the Genesis V Treatment
Screen displays after the successful completion of the self-test routine at system start-up.

Genesis V Treatment Screen

From the Genesis V Treatment Screen, you can:

• select the wavelength (refer to the User-selectable Parameters topic)
• select the fluence, pulse duration (532 nm only), and repetition rate (refer to the User-
selectable Parameters topic)
• store and recall frequently used treatment parameters (refer to the Memory Storage topic)
• monitor the measured temperature of the target tissue (refer to the Displays and Indicators
topic)
• select the system status (refer to the System Status: STANDBY and READY Modes topic)
• view and reset the pulse counter (refer to the Displays and Indicators topic)
• go to the Information & Adjustment Screen (refer to Information & Adjustment Screen topic)

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Dermastat Treatment Screen

When the Dermastat handpiece is connected to the console fiber receptacle, the Dermastat Treatment
Screen displays after the successful completion of the self-test routine at system start-up.

Dermastat Treatment Screen

From the Dermastat Treatment Screen, you can:

• select the fluence, pulse duration, and repetition rate (refer to the User-selectable
Parameters topic)
• store and recall frequently used treatment parameters (refer to the Memory Storage topic)
• select the system status (refer to the System Status: STANDBY and READY Modes topic)
• view and reset the pulse counter (refer to the Displays and Indicators topic)
• go to the Information & Adjustment Screen (refer to Information & Adjustment Screen topic)

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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
• no treatment or aiming beams are available

• the (laser status) button is amber

Laser status button

(STANDBY mode)

Location of Laser Status Button

(CoolView Treatment Screen shown)

Press the (laser status) 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 (laser status) button is green

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Laser status button

(READY mode)

Location of Laser Status Button

(CoolView Treatment Screen shown)

To return to STANDBY mode, press the (laser status) button.

When the system is in READY mode and the footswitch is depressed, treatment energy is discharged
from the handpiece, the system emits an audible tone and a yellow indicator illuminates on the Treatment
Screen to indicate laser emission.

If the system is not used for more than one minute, the system automatically goes into STANDBY 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 depressed.

WARNING
Verify that all persons in the treatment room are wearing the
appropriate treatment beam safety eyewear before placing the
system in READY mode.

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Memory Storage
The memory storage feature enables you to store and recall frequently used treatment parameters.
There are three memory banks in the memory storage feature, allowing for storage of three different sets
of treatment parameters.

To store the treatment parameters currently shown on the touchscreen display:

1. Press the (memory) button to display the memory pop-up window.

2. Press and hold number 1, 2 or 3 in the memory pop-up window until the system beeps.

Any existing treatment parameters stored in memory will be overwritten with the new parameters.

To recall previously stored treatment parameters:

1. Press the (memory) button to display the memory pop-up window.

2. Press and release the number next to the desired treatment parameters in the memory
pop-up window.

Memory pop-up
window

Memory button

Location of Memory Button

(CoolView Treatment Screen shown)

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Information & Adjustment Screen

To access the Information & Adjustment Screen, press the (info) button on the Treatment Screen.
From the Information & Adjustment Screen, you can:
• adjust the touchscreen backlighting
• adjust the volume of the laser emission indicator and other audible tones and voice prompts
(refer to the Audible Tones topic)
• adjust the laser aiming beam intensity and mode (refer to the Aiming Beam topic)
• adjust the working beam intensity (Genesis V handpiece only; refer to the Displays and
Indicators topic)
• view the versions of the system software
• go back to the Treatment Screen

Versions of system
software used

Controls for adjusting

touchscreen Versions of
backlighting handpiece software
used

Controls for adjusting

Controls for adjusting intensity of working
distance beam
volume of laser
(Genesis V only)
emission indicator and
other audible tones
and voice prompts Back to Treatment
Screen

Aiming beam button

Information & Adjustment Screen

(Genesis V screen shown)

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Aiming Beam
All aiming beam functions are controlled from the Information & Adjustment Screen. There are four
intensities in continuous and blink modes, as well as an OFF mode. To adjust the aiming beam intensity
and mode:

1. Press the (info) button on the Treatment Screen to go to the Information & Adjustment
screen.

2. Point the handpiece at the targeted treatment site.

3. Press the (aiming beam) button to display the aiming beam pop-up window.

4. Select the desired aiming beam setting from the aiming beam pop-up window.

NOTE
The aiming beam is wavelength-specific, allowing you to set
different aiming beam characteristics for the 532 nm and 1064 nm
wavelengths.

Aiming beam
pop-up window

Aiming beam
button

Location of Aiming Beam Button

(CoolView Information & Adjustment Screen shown)

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Audible Tones and Voice Prompts

The excel V+ system console emits a single audible tone with every control screen selection or when an
error condition has occurred. Additionally, an audible laser emission indicator is generated during
treatment exposure.

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 excel V+ system console also emits audible voice prompts when a new wavelength is selected or a
new handpiece is connected to the console. For example, if you change the wavelength from 1064 nm
to 532 nm, an audible voice prompts says “532”.

The volume of audible tones and voice prompts can be increased from the minimum setting up to a
setting where the tones and prompts can be clearly heard over the system sound level. To adjust the
volume, press the (info) button on the Treatment Screen to go to the Information & Adjustment
Screen.

NOTE
The volume of audible tones and voice prompts cannot be muted.

Controls for adjusting

volume of laser
emission indicator and
other audible tones
and voice prompts

Location of Volume Controls

(Genesis V Information & Adjustment Screen shown)

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Displays and Indicators

The excel V+ system includes various indicators and controls to ensure safe and accurate operation.

On the CoolView Treatment Screen:

• A pulse counter records the total number of laser pulses that the system has fired since the
counter was last reset, and a (reset) button allows you to reset the counter.
• A temperature display shows the actual temperature of the CoolView handpiece sapphire
cooling window.
• A laser emission indicator illuminates when the system is set to READY and the footswitch
is pressed.

Illuminated laser
emission indicator Pulse counter display
Pulse counter reset
button

Temperature display

CoolView Treatment Screen

On the Genesis V Treatment Screen:

• A pulse counter records the total number of laser pulses that the system has fired since the
counter was last reset, and a (reset) button allows you to reset the counter.
• A temperature display shows the measured temperature of the target tissue.
• A laser emission indicator illuminates when the system is set to READY and the footswitch
is pressed.

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Illuminated laser
emission indicator Pulse counter display
Pulse counter reset
button

Temperature display

Genesis V Treatment Screen

On the Genesis V handpiece:

• An integrated temperature sensor and six LED temperature indicators enable thermal
monitoring of the target tissue. The sensor measures the temperature of the target tissue,
and the LEDs indicate the measured temperature. The following table shows the
temperature ranges associated with each LED:

Temperature
LED Color
Range

Red 47 - 50º C

Yellow 43 - 46º C

Yellow 39 - 42º C

Green 35 - 38º C

Green 31 - 34º C

Green 26 - 30º C

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LED temperature
indicators

• A working distance beam facilitates proper positioning of the handpiece. When the working
distance beam is centered within the aiming beam, the handpiece is at the optimal working
distance of 3.7 cm and at the correct distance to obtain an accurate temperature reading of
the target tissue.

cm ng Temperature sensor
3.7 l worki (not visible)
tima e)
(op istanc
d
Working distance beam

Aiming beam and treatment

beam (not visible)

NOTE
You can adjust the intensity of the working distance beam from the
Information & Adjustment Screen.

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On the Dermastat Treatment Screen:

• A pulse counter records the total number of laser pulses that the system has fired since the
counter was last reset, and a (reset) button allows you to reset the counter.
• A laser emission indicator illuminates when the system is set to READY and the footswitch
is pressed.

Illuminated laser
emission indicator Pulse counter display
Pulse counter reset
button

Dermastat Treatment Screen

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User-selectable Parameters
In pulsed lasers, such as excel V+, fluence and pulse duration affect the nature of laser-tissue
interaction. The excel V+ 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 photoselective thermolysis effects.

NOTE
Fluence, pulse duration, and spot size settings are interrelated.
Therefore, not all parameter combinations are simultaneously
available. When you reach the minimum setting for a parameter, the
decrease button is disabled; when you reach the maximum setting
for a parameter, the increase button is disabled. If the desired
setting for a particular parameter is unavailable, try changing one or
both of the other parameters until the desired setting is available.

CoolView Handpiece Instructions

As described in the CoolView Handpiece User Interface Modes section earlier in this chapter, there are
two user interface modes for use with the CoolView handpiece. For instructions on operating in
navigation mode, proceed to the Selecting Treatment Settings in Navigation Mode section below. For
instructions on operating in expert mode, skip to the Selecting Treatment Parameters in Expert Mode
section that follows.

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Selecting Treatment Parameters in Navigation Mode

To operate in navigation mode, press the “Tap here to Select 532nm Application” or “Tap here to Select
1064nm Application” button on the CoolView Select Screen or the CoolView Treatment Screen.

Location of Navigation Buttons on CoolView Select Screen

Location of Navigation Button on CoolView Treatment Screen

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After pressing the Navigation button, the CoolView Treatment Screen displays with the Skin Type menu
open:

CoolView Treatment Screen with Skin Type Menu Open

Press the button that corresponds to the patient’s skin type. The Treatment Category menu displays:

CoolView Treatment Screen with Skin Type and Treatment

Category Menus Open

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Press the button that corresponds to the desired treatment category. The Treatment Subcategory menu
displays:

CoolView Treatment Screen with Skin Type, Treatment

Category and Treatment Subcategory Menus Open

Press the button that corresponds to the desired treatment subcategory. The CoolView Treatment
Screen displays, with the selected skin type, treatment category and treatment subcategory displayed in
the Navigation button and the recommended range of settings highlighted in green:

Sample CoolView Treatment Screen in Navigation Mode

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Not all navigation selections are available for all combinations of wavelength, skin type and/or treatment
category. If a navigation selection is unavailable, it is greyed out, as shown in the example below:

Example of Unavailable Navigation Selection (i.e., Red Scar subcategory)

If you attempt to select a treatment category or subcategory that is unavailable, one of the following pop-
up messages displays:

The first two pop-up messages indicate that the desired application is unsupported for the currently
selected wavelength. Clear the message by pressing the button, and then select the alternate
wavelength by pressing the appropriate wavelength button at the bottom left corner of the CoolView
Treatment Screen.

The third pop-up message indicates that the desired application is unsupported for both wavelengths.
Clear the message by pressing the button, and then select a different combination of skin type,
treatment category and treatment subcategory, or switch to expert mode to manually set the treatment
parameters.

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Exiting Navigation Mode

To exit navigation mode, press the on the Navigation button or press either wavelength button on the
CoolView Treatment screen.

Navigation button

Wavelength buttons

Location of Navigation and Wavelength Buttons on

CoolView Treatment Screen

After exiting navigation mode, the CoolView Treatment Screen displays in expert mode. You can either
manually select parameters in expert mode, as described in the following section, or you can select new
parameters in navigation mode, as described in the previous section.

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Selecting Treatment Parameters in Expert Mode

To operate in expert mode, press the “Tap here to Set Parameters” button on the CoolView Select
Screen.

Location of Expert Mode Button on CoolView Select Screen

NOTE
If you are currently in navigation mode, exit navigation mode as
described on the previous page.

After pressing the “Tap here to Set Parameters” button, or after exiting navigation mode, the CoolView
Treatment Screen displays:

CoolView Treatment Screen in Expert Mode

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Selecting the Laser Wavelength

The excel V+ features two wavelengths: 532 nm and 1064 nm. To select the wavelength from the
CoolView Select Screen, press the “Tap here to Select 532nm Application” or “Tap here to Select
1064nm Application” button. To select the wavelength from the CoolView Treatment Screen, press the
“532 nm” or “1064 nm” button at the bottom left corner of the screen.

Location of Wavelength Selection Buttons on CoolView Select Screen

Location of Wavelength Selection Buttons on CoolView Treatment Screen

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Selecting the Laser Spot Size

To select the laser spot size:

1. Press the - and + buttons next to the (spot size) display on the CoolView Treatment
Screen to select the approximate laser spot size.

Location of Spot Size Controls and Display on

CoolView Treatment Screen

The selected spot size appears in the (spot size) display on the CoolView Treatment Screen.

NOTE
When you reach the minimum spot size setting, the -
button is disabled; when you reach the maximum spot size setting,
the + button is disabled. Changing the fluence and/or pulse duration
settings may make available a wider range of spot size settings.

CAUTION
In navigation mode, if you select a spot size that is not within the
recommended range of settings for the specified skin type and
application, the icon appears next to the spot size display to alert
you that the spot size is not recommended. You are still able to
operate the laser with the selected spot size, but you should
proceed with caution.

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CoolView Treatment Screen in Navigation Mode with

Spot Size Setting Outside Recommended Range

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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 next to the Fluence display.

CAUTION
The fluence shown in the Fluence display indicates the fluence
delivered to the tissue.

NOTE
When you reach the minimum fluence setting for the current
treatment parameters, the button is disabled; when you reach
the maximum fluence setting for the current treatment parameters,
the button is disabled. Changing the pulse duration and/or spot
size settings may make available a wider range of fluence settings.

Location of Fluence Controls and Display on

CoolView Treatment Screen

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CAUTION
In navigation mode, if you select a fluence, pulse duration or
repetition rate setting that is not within the recommended range of
settings for the specified skin type and application, a black and
yellow bar displays in the corresponding bar indicator to alert you
that the setting is not recommended. You are still able to operate
the laser with the setting, but you should proceed with caution.

CoolView Treatment Screen in Navigation Mode with

Fluence Setting Outside Recommended Range

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Selecting the Pulse Duration

Pulse duration, or pulse width, refers to the amount of time during which therapeutically effective laser
energy is delivered, measured in milliseconds (ms). Select the desired pulse duration by pressing the
and buttons next to the Pulse Duration display.

NOTE
When you reach the minimum pulse duration setting for the current
treatment parameters, the button is disabled; when you reach
the maximum pulse duration setting for the current treatment
parameters, the button is disabled. Changing the fluence and/
or spot size settings may make available a wider range of pulse
duration settings.

Location of Pulse Duration Controls and Display on CoolView

Treatment Screen

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Selecting the Repetition Rate

Repetition rate refers to the number of laser pulses delivered per second, measured in hertz (Hz). Select
the desired repetition rate by pressing the or button next to the Rep Rate display.

NOTE
When the repetition rate is set to the minimum setting, the
button is disabled. When the repetition rate is set to the maximum
setting, the button is disabled.

Location of Repetition Rate Controls and Display on

CoolView Treatment Screen

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Adjusting the Temperature of the Sapphire Cooling Window

The CoolView handpiece features an integrated sapphire cooling window, which allows you to adjust
epidermal cooling to increase safety and efficacy. To adjust the temperature of the sapphire cooling
window:

1. Press the (temperature) button on the CoolView Treatment Screen to display the
temperature pop-up window.

2. Select the desired temperature setting from the temperature pop-up window.

If you are in READY mode when you change the temperature setting, the system will revert to STANDBY
mode. When you press the (laser status) button to toggle to READY mode, the window will cool
to the selected temperature.

NOTE
The selected temperature displays in the temperature button. The
actual temperature of the sapphire cooling window displays in the
temperature display next to the temperature button.

Temperature
pop-up window

Temperature Temperature
button display

Location of Temperature Button, Window and Display on

CoolView Treatment Screen

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Genesis V Handpiece Instructions

Selecting the Laser Wavelength

The excel V+ features two wavelengths: 532 nm and 1064 nm. Select the wavelength by pressing the
“532 nm” or “1064 nm” button at the bottom left corner of the screen.

Location of Wavelength Selection Buttons on Genesis V Treatment 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 next to the Fluence display.

CAUTION
The fluence shown in the Fluence display indicates the fluence
delivered to the tissue.

NOTE
When you reach the minimum fluence setting for the current
treatment parameters, the button is disabled; when you reach
the maximum fluence setting for the current treatment parameters,
the button is disabled.

Location of Fluence Controls and Display on

Genesis V Treatment Screen

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Selecting the Pulse Duration (532 nm only)

Pulse duration, or pulse width, refers to the amount of time during which therapeutically effective laser
energy is delivered, measured in milliseconds (ms). When using the Genesis V handpiece in 532 nm
mode, two pulse duration settings are available: 0.5 ms and 1ms. Select the desired pulse duration by
pressing the and buttons next to the Pulse Duration display.

Location of Pulse Duration Controls and Display on Genesis V

Treatment Screen

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Selecting the Repetition Rate

Repetition rate refers to the number of laser pulses delivered per second, measured in hertz (Hz). Select
the desired repetition rate by pressing the or button next to the Rep Rate display.

NOTE
When the repetition rate is set to the minimum setting, the
button is disabled. When the repetition rate is set to the maximum
setting, the button is disabled.

Location of Repetition Rate Controls and Display on

Genesis V Treatment Screen

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Dermastat Handpiece Instructions

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 next to the Fluence display.

CAUTION
The fluence shown in the Fluence display indicates the fluence
delivered to the tissue.

NOTE
When you reach the minimum fluence setting for the current
treatment parameters, the button is disabled; when you reach
the maximum fluence setting for the current treatment parameters,
the button is disabled. Changing the pulse duration setting
may make available a wider range of fluence settings.

Location of Fluence Controls and Display on

Dermastat Treatment Screen

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Selecting the Pulse Duration

Pulse duration, or pulse width, refers to the amount of time during which therapeutically effective laser
energy is delivered, measured in milliseconds (ms). Select the desired pulse duration by pressing the
and buttons next to the Pulse Duration display.

NOTE
When you reach the minimum pulse duration setting for the current
treatment parameters, the button is disabled; when you reach
the maximum pulse duration setting for the current treatment
parameters, the button is disabled. Changing the fluence
setting may make available a wider range of pulse duration settings.

Location of Pulse Duration Controls and Display on Dermastat

Treatment Screen

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Selecting the Repetition Rate

Repetition rate refers to the number of laser pulses delivered per second, measured in hertz (Hz). Select
the desired repetition rate by pressing the or button next to the Rep Rate display.

NOTE
When the repetition rate is set to the minimum setting, the
button is disabled. When the repetition rate is set to the maximum
setting, the button is disabled.

Location of Repetition Rate Controls and Display on

Dermastat 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 (the circuit breaker) is
turned on (in the 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.

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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.

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,
then turn the keyswitch to the START position.

Treatment beam is not present, although aiming beam operates properly.

Probable Cause There is an internal laser system failure.

Suggestion Contact Cutera Service (refer to Appendix D).

Treatment and aiming beams are not present. Touchscreen displays and indi-
cators are normal.

Probable Cause The system is in STANDBY mode.

Suggestion Place the system in READY mode.

Probable Cause There is an internal laser system failure.

Suggestion Contact Cutera Service (refer to Appendix D).

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Inadequate or no aiming beam.

Probable Cause The aiming beam is either set to “OFF” or at a low setting.

Suggestion Go to READY mode and adjust the aiming beam intensity on

the excel V+ Information & Adjustment Screen. If adjusting
the aiming beam does not resolve the problem, contact
Cutera Service (refer to Appendix D).

System displays error code 1225 or 1230 during the procedure.

Probable Cause CoolView handpiece cooling tip is above the preset tempera-
ture.

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 Mainte-
nance topic.
Ensure that the room temperature is below 27° C.

System shuts down during operation with no touchscreen display.

Probable Cause The building power (main electrical service) has been inter-
rupted.

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 UP posi-
tion.

Probable Cause Remote interlock is in use and the treatment room door has
been opened.

Suggestion Close the treatment room door and restart the system.

Low or no energy output (patient reports no sensation) from handpiece.

Probable Cause A handpiece lens is dirty or damaged.

Suggestion Confirm that laser energy is not being emitted on the test
area, such as on an arm. Check to see if the aiming beam is
present. Clean the lens as described in this manual.
If the problem is not resolved, contact Cutera Service (refer
to Appendix D).

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

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 con-

sole.

NOTE
Press the button to clear the advisory message.

“Water Low” advisory pop-up screen appears on the touch screen.

Probable Cause The system is low on water.

Suggestion Turn off the system, and add water as instructed in the Rou-
tine User Maintenance topic. Restart the system to continue
with treatments.

Error Code Guide

The excel V+ system utilizes 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 will appear with a
corresponding error code(s). Some errors serve as a warning and are clearable by simply pressing 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 pressing the button.

NOTE
If an error cannot be cleared, or if an error persists or reappears,
note the error code(s) and contact Cutera Service (refer to Appendix
D).

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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 laser performance.

System Repair
All system repairs should be performed by a Cutera-certified service engineer. For training and
information, contact your local Cutera representative.

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 handpiece During treatment, as needed, and between
patient use

Inspect and clean the heat exchanger intake Inspect weekly; clean monthly, or as needed

Fill the coolant reservoir On installation or if water evaporates

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
the system electronics.

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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, the following optical surfaces need to be maintained:
• CoolView handpiece: recessed lens, patient contact, and proximal surfaces of cooling
window
• Genesis V handpiece: recessed lenses
• Dermastat handpiece: recessed lens

Proximal surface of
cooling window

Patient contact
surface of Recessed lens
cooling window

Location of CoolView Handpiece Optical Surfaces

Recessed lenses

Location of Genesis V Handpiece Optical Surfaces

Recessed lens

Location of Dermastat Handpiece Optical Surface

(handpiece cap removed)

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Inspecting and Cleaning the External Surfaces of the Handpiece

Inspect and clean the handpiece housing, CoolView treatment guide, Dermastat standoff (if used), 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(es)

The recessed handpiece lens(es) is (are) located at the distal end of the handpiece. Prior to treatment,
as well as periodically during treatment, inspect the lens(es) for cracks and debris. If the handpiece
lens(es) is (are) cracked or otherwise damaged, do not use the handpiece. If the handpiece lens(es) is
(are) dirty, clean as directed below.

WARNING
The system must be turned OFF or in STANDBY mode prior to
inspecting the lens(es). Do not inspect the lens(es) 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.

1. Sani-Cloth Plus and Sani-Cloth HB are registered trademarks of Professional Disposables

International, Inc.

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CAUTION
Inspecting and cleaning the handpiece lens(es) is the responsibility
of the practitioner. If the lens(es) is (are) not properly maintained,
debris can build up on the surface of the lens(es), leading to
permanent damage to the lens(es) and, ultimately, permanent
damage to the handpiece optical system. If debris cannot be
removed from the lens(es), the handpiece must be replaced.

CAUTION
Do not use germicidal disposable wipes to clean the recessed
lens(es). Doing so may damage the lens(es) and require handpiece
replacement.

NOTE
Debris from patients can accumulate on the lens(es). It may be
necessary to clean the lens(es) periodically during treatment.

NOTE
It may be necessary to use a flashlight to inspect the Genesis V
handpiece lenses.

NOTE
Remove the Dermastat handpiece cap to facilitate inspection and
cleaning of the handpiece lens. Be sure to replace the cap before
use.

Clean the handpiece lens(es) 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.

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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(es).

3. Gently wipe the surface of the lens(es). Refer to the pictures below.

Recessed lens

Location of CoolView Handpiece Lens

Recessed lenses

Location of Genesis V Handpiece Lenses

Recessed lens

Location of Dermastat Handpiece Lens

(handpiece cap removed)

4. Inspect the lens(es). If necessary, clean the lens(es) again with a new cotton swab.

CAUTION
The lens(es) must be clean before treating a patient. Chips, pits,
cracks or burned spots on the lens(es) are not acceptable, and a
handpiece with these types of defects must be replaced.

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Inspecting and Cleaning the CoolView Handpiece 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.

Proximal surface

Patient contact
surface

Location of Patient Contact and Proximal Surfaces of CoolView Handpiece Window

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.

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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.

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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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.

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 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 distilled water be used.

To completely fill the coolant reservoir in the system:

1. Turn off the system.

2. Remove the reservoir fill cap at the rear of the system.

3. Add water to the reservoir. Use only clean, unused distilled water provided. Carefully fill
the reservoir. Do not overfill.

4. After the reservoir is full, turn the system keyswitch to the START position and release to
the 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.

6. Turn the keyswitch to the OFF position.

7. Top off the reservoir carefully.

8. Repeat steps 4 thru 7 until the reservoir is full.

NOTE
The coolant capacity of the system is approximately one
half gallon.

9. Replace the fill cap.

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.

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Remote Interlock Pin Assignments

In order to connect an external door switch to the Remote Interlock plug, the user must purchase a
replacement four pin Mini DIN Plug and an external door switch. Connect the external door switch to the
pin assignment found 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 V+ system is available in several electrical configurations. Electrical power should be set up
according to the model ordered. The two line wires in the conduit shall be connected to the building
power (both have live voltages), and the green/yellow wire must be connected to ground.

Systems Designed for Use Outside of Europe

The 120 VAC configurations must be supplied from a dedicated 120±10% VAC, single-phase, 50/60
Hertz source. The wiring should be rated for 20 amps (as per local codes) “Hospital Grade” (NEMA L-
20P or NEMA L-30P). The system can be installed with a removable or lockable wall plug. The 120 VAC
configuration may be changed to a 220 VAC configuration. This internal change must be made by a
Cutera-certified service representative. Call your Cutera representative for information.

The 220 VAC configuration must be supplied from a dedicated 220±10% VAC, single-phase, 50/60 Hertz
source. The wiring should be rated for 16/20 Amps (as per local codes) “Hospital Grade” (NEMA L6-20P
or NEMA L6-30P). The system can be installed with a lockable wall plug. Such a connection will ensure
compliance with allowable leakage current levels per IEC 60601-1 for this device. Leakage current for
these systems does not exceed 500 A.

Systems Designed for Use in European Communities Under MDD

In order to comply with the European Communities Medical Devices Directive 93/42/EEC and
harmonized standard EN 60601-2-22, the 220 VAC configured excel V+ system must be either
permanently connected to a 16A, 220 VAC 50 Hz supply mains in accordance with national wiring
regulations, or connected by means of a dedicated single phase, 16A, 220V wall socket and lockable
plug combination designed to ensure that the connection is “mechanically secured against accidental
loosening”. Such a connection will ensure compliance with allowable leakage current levels per IEC
60601-1 for this device. Leakage current for these systems does not exceed 500 A.

Removable or Lockable Wall Socket and Plug Configurations

If your system is installed with a removable plug or wall socket and lockable plug configuration prior to
installation, the customer’s engineer or electrical contractor will be responsible for ensuring that the
proper electrical requirements are available at the site.

Systems Designed for Use in European Communities Under MDD

To comply with the European Communities Medical Devices Directive 93/42/EEC, the 16A, 250V wall
socket and lockable plug combination must comply with EN 60309 (=IEC 309).

The wall socket and plug combination must meet the following specifications:

Plug: MK LN 9024, 16A 220V, IP67, IEC 309

Wall Socket: MK LN 9324, 16A 220V, IP67, IEC 309

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System Specifications
Specifications subject to change without notice.

Treatment Beam

Type High Power, Frequency-doubled Nd:YAG High Power, Long Pulse Nd:YAG

Wavelength 532 nm 1064 nm

Output 13.5 J Max. 100 J Max.

Fluence Coolview: 1.8 to 42 J/cm2 CoolView: 2 to 300 J/cm2

Genesis V: 0.5 to 2 J/cm2 Genesis V: 4 to 7 J/cm2

Dermastat: 6 to 40 J/cm2

Pulse Duration CoolView: 0.5 to 40 ms CoolView: 5 to 60 ms

Genesis V: 0.5 and 1 ms Genesis V: 0.3 ms
Dermastat: 0.5 to 20 ms

Repetition Rate CoolView: 0 Hz (single shot) to 4 Hz CoolView: 0 Hz (single shot) to 2 Hz

Genesis V: 0 Hz (single shot) to 4 Hz, 10 Genesis V: 0 Hz (single shot) to 10 Hz
Hz
Dermastat: 0 Hz (single shot) to 4 Hz

Treatment Spot CoolView: 2 to 16 mm circular spot CoolView: 2 to 16 mm circular spot

Genesis V: 8 mm circular spot Genesis V: 8 mm circular spot
Dermastat: 2 mm circular spot

Delivery System CoolView and Genesis V handpieces with CoolView and Genesis V handpieces with
user-detachable umbilical user-detachable umbilical
Dermastat handpiece with shielded fiber

Working Distance CoolView: n/a CoolView: n/a

Genesis V: 3 to 4 cm Genesis V: 3 to 4 cm
Dermastat: 1 to 1.5 cm

Epidermal Cooling CoolView: User-adjustable contact sap- CoolView: User-adjustable contact

phire cooling sapphire cooling
Genesis V: n/a Genesis V: n/a
Dermastat: n/a

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): 16.1 in X 24 in X 34.8 in (.41 m x .61 m x .88 m)

Weight: 185 lbs (84.1 kg)

Operating length of umbilical: 9 ft (2.7 m)

Minimum bend radius of umbilical: Storage 5.2 in (132 mm)

Momentary 2.6 in (66 mm)

Electrical Requirements
Voltage, Current 100-120 VAC, 20 A or 200-240 VAC, 16 A

Frequency 50/60 Hz

Environmental Requirements
Temperature Operating 15º 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 Operating: 60 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
Coolview Handpiece Window Sapphire > 1 min 20º C
CoolView Handpiece Treatment Guide Metal > 1 min 20º C

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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 60825:2014

Type BF

Applied Part Handpiece

Eye Safety

Nominal Ocular Hazard Distance 1.45E+5 m at 532 nm

1.33E+5 m at 1064 nm

Minimum Optical Density for 5.89 at 532 nm

Protective Eyewear 5.81 at 1064 nm

Maximum Permissible Exposure 1.35E-4 W/cm2 at 532 nm

4.02E-4 W/cm2 at 1064 nm

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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.

WARNING
Failure to perform the annual calibration may contribute to device
malfunction and to potential patient injury.

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 the excel V+ 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 D).

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).

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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.

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.

End of Life Disposal - Environmental Information

The excel V+ 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).

Warranty Information

For specific and detailed warranty information for the excel V+ system, please refer to the first page of
your purchase “Agreement” and the last page of the “Terms and Conditions of Sale”.

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Safety and Regulatory

Introduction
The excel V+ system, when properly used by trained personnel, is a safe and effective instrument 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 532 nm and 1064 nm 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
Laser safety eyewear is routinely required with most laser systems. 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 532 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, ANSI Z136.1 or
European Standard EN 60825:2014, Annex A.

The excel V+ system is a Class IV Laser Product as defined by the U.S. Code of Federal Regulations
and a Class 4 Laser Product as defined by the European Communities Medical Devices Directive.

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WARNING
The excel V+ produces visible green (532 nm) light, as well as
invisible (1064 nm) light, both of which can cause permanent eye
damage. Never look directly into the handpiece even when wearing
protective eyewear. Never look directly into the laser beam or at
scattered light from metallic or other reflective surfaces. Both direct
and reflected laser beams may contain sufficient energy to cause
permanent eye damage.

All personnel operating excel V+ or in the vicinity of the system, including the patient, staff personnel and
observers, should wear protective eyewear with sufficient protection (optical density or shade factor
specified in System Specifications or greater) for the 532 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
laser while the system is 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).
• The American National Standard for Safe Use of Lasers
(ANSI Z136.1).
• European Standard EN 60825:2014, 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 Eye Safety in the System Specifications section of this manual.

In addition to providing the required laser 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 laser 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.

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
laser system aperture while the system is energized. Severe eye
damage could occur. Turn off the system before inspecting any
delivery system or laser component.

WARNING
Verify that laser safety eyewear has sufficient protection for the 532
nm and 1064 nm wavelengths.

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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 V+ system is allowed.

CAUTION
The excel V+ system 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 the
STANDBY mode. Maintaining the system in the STANDBY mode
prevents accidental laser exposure if the footswitch is inadvertently
pressed.

WARNING
Never place hands or other objects in the path of the laser 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
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 excel V+ 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 obscures the operative field and is noxious to those
who come in contact with it. The plume presents a possible pollution
hazard and should be effectively evacuated.

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 the handpiece for any damage, excessive wear or
crimping that could affect system performance or safe operation.

CAUTION
Do not place any unnecessary stress on the umbilical cable (i.e., by
pulling on it, tightly bending it or twisting the handpiece). See
System Specifications topic for additional information on minimum
bend radius.

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 80

CAUTION
Always verify that the treatment parameters are correct before
activating the system.

CAUTION
The system should always be in STANDBY mode until the
handpiece is safely positioned at the area to be treated.

CAUTION
Before placing the system in READY mode, confirm that the laser
aperture on the handpiece is safely positioned to prevent
unintended treatment exposure.

NOTE
The recessed handpiece lens(es) and the CoolView sapphire
cooling window 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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 81

Regulatory Compliance
excel V+ is designed to comply with the following:
• 21 CFR Chapter I, Subchapter J, as administered by the Center for Device and Radiological
Health of the US Food and Drug Administration (FDA)
• US Federal Performing Standards 21 CFR 1040.10 and 1040.11 (2015), IEC 60601-1
(Edition 3.1, 2012), IEC 60601-1-2 (Edition 4.0, 2014), IEC 60601-1-6 (Edition 3.1, 2013),
IEC 62366 (Edition 1.1, 2014), IEC 60601-2-22 (Edition 3.1, 2012), and IEC 60825-1
(Edition 3.0, 2014)
• European Medical Device Directive (MDD) 93/42/EEC

Location of Controls
Operation and adjustment controls are located so that the user need not be exposed to laser radiation
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 ON (or START) position and the system will only operate with the key in place.
When treatments are complete or the system is not is use, always remove and store the key.

Emergency Off Push-Button

The system can be immediately shut down, terminating laser or light energy emission by pushing the red,
mushroom-shaped emergency off button that is located in the upper right hand corner of the control
panel. 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 will emit an audible tone and the yellow laser emission icon will illuminate on the
Treatment Screen.

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 down the system if the treatment room door is opened.

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Protective Housing
The excel V+ system has a protective housing that prevents 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 laser system contains a “normally closed” safety shutter that prevents laser emission when in the
closed position. The shutter is opened only when the system is in the READY mode.

Audible Emission Indicator

Each laser pulse delivered 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 pulse increments.

Manual Reset
If the system shuts down during operation (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
keyswitch 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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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.

Non-interlock housing label

Coolant reservoir label

(“Distilled Water Only”)

Regulatory compliance labels

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

2D barcode
Global Trade Identification
(01)00816722021311 Number (GTIN)
(11)YYMMDD Date of Manufacture
(21)EVPFXXXXX Serial Number

Unique Device Identifier (UDI) Label

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 84

System Console Labels

Dependingon
Depending
Depending
Depending
Depending
Depending
Depending
Depending on
on
ononthe
on
on
on theparticular
the
the
the
the
the
the particularprocedure
particular
particular
particular
particular
particular
particular procedure
procedure
procedure
procedure
procedure
procedure
procedure
performed,
performed,
performed,
performed,
performed,
performed,
performed,
performed,this this
this
this
this
this
this product
thisproduct
product
product
product
product
product
productandand
and
and
and
and
and
andthethe
the
the
the
the
the use
theuse
use
use
use
use
use
use
thereofmay
thereof
thereof
thereof
thereof
thereof
thereof
thereof maybe
may
may
may
may
may
may bebecovered
be
be
be
be
be coveredby
covered
covered
covered
covered
covered
covered bybyone
by
by
by
by
by oneor
one
one
one
one
one
one or
orormore
or
or
or
or more
more
more
more
more
more
more
of
of
of
ofof
of
of
ofthe
thethe
the
the
the
the following
thefollowing
following
following
following
following
following
followingU.S. U.S.
U.S.
U.S.
U.S.
U.S.
U.S. and
U.S.and
and
and
and
and
and corresponding
andcorresponding
corresponding
corresponding
corresponding
corresponding
corresponding
corresponding
excel V+ Laser System foreign
foreign
foreign
foreign
foreign
foreign
foreign
foreignpatentspatents
patents
patents
patents
patents
patents
patentsand and
and
and
and
and
and patent
patent
andpatent
patent
patent
patent
patent applications:
applications:
patentapplications:
applications:
applications:
applications:
applications:
applications:
INVISIBLE AND VISIBLE LASER RADIATION 7,465,307;7,326,199;
7,465,307;
7,465,307;
7,465,307;
7,465,307;
7,465,307;
7,465,307;
7,465,307; 7,326,199;7,703,458;
7,326,199;
7,326,199;
7,326,199;
7,326,199;
7,326,199;
7,326,199; 7,703,458;and
7,703,458;
7,703,458;
7,703,458;
7,703,458;
7,703,458;
7,703,458; and
and
and
and
and
and
and
REF EXCELV 7,780,652
AVOID EYE OR SKIN EXPOSURE TO 7,780,652
7,780,652
7,780,652
7,780,652
7,780,652
7,780,652
7,780,652
SN EVPFXXXXX DIRECT OR SCATTERED RADIATION
YYYY-MM-DD Output: 13.5 J Max at 532 nm
Brisbane, CA 100 J Max at 1064 nm
XXX-XXXV~, XXA, XXHz Duration: 0.5-40 ms at 532 nm Danger label
0.3-60 ms at 1064 nm
Class 4 Laser Product
Per IEC 60825-1:2014
Aim Beam: ≤ 1 mW Max at 635 nm, Class 2
0044

Complies with 21 CFR 1040.10 and 1040.11

except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007 Certification
30°C label
Rx only
15°C

3002722
3002722
3002722
3002722
3002722
3002722
Cutera,Inc.,
Cutera,
Cutera,
Cutera, Inc.,3240
Inc.,
Inc., 3240Bayshore
3240
3240 BayshoreBlvd.,
Bayshore
Bayshore Blvd.,Brisbane
Blvd.,
Blvd., BrisbaneCA
Brisbane
Brisbane CA94005
CA
CA 94005, USA
94005
94005

excel V+ Identification Label

Emergency Stop Button Non-interlock Housing Label Tilting Hazard Label

Located on top of console Located on rear of system Located on sides of system console
(next to red button) 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

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Handpiece Labels

Laser Radiation Warning

Warning of laser radiation from adjacent aperture.

Location of Laser Aperture Label on CoolView Handpiece

Laser Radiation Warning

Warning of laser radiation from adjacent aperture.

Location of Laser Aperture Label on Genesis V Handpiece

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Laser Radiation Warning

Warning of laser radiation from adjacent aperture.

Location of Laser Aperture Label on Dermastat Handpiece

Handpiece Label

Located on CoolView and Genesis V handpiece connectors.

Located on Dermastat fiber cable.
(Genesis V handpiece label shown)

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Electromagnetic Compatibility
The excel V+ design complies with IEC 60601-1-2 (Edition 4.0) requirements for electromagnetic
compatibility (EMC) with other devices. Like other electrical medical equipment, the excel V+ 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 V+.

WARNING
Do not use cables or accessories other than those provided with the
excel V+, as this may result in increased electromagnetic emissions
or decreased immunity to such emissions.

WARNING
If the excel V+ is used adjacent to or stacked with other equipment,
observe and verify normal operation of the excel V+ 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 V+.

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

The excel V+ is intended for use in the electromagnetic environment specified below. The customer or the
user of the excel V+ should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment: Guidance

RF emissions CISPR 11 Group 1 The excel V+ uses RF energy only for its internal func-
tion; therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.

RF emissions CISPR 11 Class A The excel V+ is suitable for use in all establishments,
including domestic establishments and those directly
Harmonic emissions Class A connected to the public low voltage power supply net-
IEC 61000-3-2 work that supplies buildings used for domestic purposes.

Voltage Fluctuations/flicker Complies

emissions IEC 61000-3-3

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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The excel V+ is intended for use in the electromagnetic environment specified below. The customer or the user
of the excel V+ should ensure that it is used in such environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment:
Guidance

Electrostatic ±8kV contact ±2, 4, 6, 8kV contact Floor should be wood, concrete, or
Discharge (ESD) ceramic tile. If floors are covered with
±15kV air ±2, 4, 8, 15kV air synthetic material, the relative humidity
IEC 61000-4-2 should be at least 30-60%.

Electrical fast ±2kV for power sup- ±2kV line to ground Mains power quality should be that of a
transient/burst ply lines typical commercial or hospital
±1kV line to line environment.
IEC 61000-4-4 ±1kV for input/output
lines
Surge ±1kV differential ±0.5, 1kV Mains power quality should be that of a
mode typical commercial or hospital
IEC 61000-4-5 differential mode environment.
±2kV common mode
±0.5, 1, 2kV

common mode
Voltage dips, 0% UT .5 cycle 0% UT .5 cycle Mains power quality should be that of a
short typical commercial or hospital
interruptions and 0% UT 1 cycle 0% UT 1 cycle environment. If the user of the excel V+
voltage variations requires continued operation during
on power supply 70% UT 25 cycles 70% UT 25 cycles power mains interruptions, it is
input lines recommended that the excel V+ be
0% UT 5 Sec 0% UT 5 Sec powered from an uninterruptible power
IEC 61000-4-11 supply or a battery.

Power frequency 30 A/m 30 A/m Power-frequency magnetic fields

(50/60Hz) should be at levels characteristics of a
magnetic field typical location in a typical commercial
or hospital environment.
IEC 61000-4-8

NOTE: UT is the AC mains voltage prior to application of the test level.

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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The excel V+ is intended for use in the electromagnetic environment specified below. The customer or the user of
the excel V+ should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance

Conducted RF 0.15 - 80 MHz 0.15 - 80 MHz Portable and mobile RF communications

IEC 61000-4-6 equipment should be used no closer to any
3 Vrms & 6 Vrms in 3 V rms & 6 Vrms in part of the excel V+, including its cables,
ISM & amateur bands ISM & amateur than the recommended separation
1 kHz bands 1 kHz distance calculated from the equation
applicable to the frequency of the
AC Mains AC Mains transmitter.
Radiated RF 80 MHz - 2.7 GHz 80 MHz - 2.7 GHz Recommended Separation Distance
IEC 61000-4-3 3 V/m 80% @ 1 kHz 3 V/m 80% @ 1 kHz d = 1.17 √P
d = 1.17 √P 80MHz to 800MHz
d = 2.33 √P 800MHz to 2.5GHz
Proximity field Spot frequencies Spot frequencies
from RF wireless 385MHz – 5.750 GHz 385MHz – 5.750 where P is the maximum output power
communications Pulse Modulation GHz Pulse rating of the transmitter in watts (W)
equipment Modulation according to the transmitter manufacturer
IEC 61000-4-3 and d is the 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 V+ is used exceeds
the applicable RF compliance level above, the excel V+ should be observed to verify normal operation. If abnor-
mal performance is observed, additional measures may be necessary, such as reorienting or relocating the excel
V+.

(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 excel V+

The excel V+ is intended for use in an electromagnetic environment in which radiated RF disturbances are con-
trolled. The user of the excel V+ can help prevent electromagnetic interference by maintaining a minimum dis-
tance between portable and mobile RF communications equipment (transmitters) and the excel V+ 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 absorp-
tion and reflection from structures, objects, and people.

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Clinical Applications
General Indications for Use
The excel V+ is intended for use in surgical and aesthetic applications requiring selective
photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic
surgery and dermatology.

532 nm Indications
The 532 nm wavelength is indicated for the coagulation and hemostasis of benign vascular and
cutaneous lesions in dermatology including, but not limited to, the following general categories:
• Benign vascular lesions, including angiomas, hemangiomas, port wine stains, venous
anomalies, telangiectasia (facial or extremities), leg veins and poikiloderma of Civatte
• Benign pigmented lesions, including nevi and lentigines
• Benign cutaneous lesions, including warts and scars
• Chloasma

1064 nm Indications
The 1064 nm wavelength is indicated for the coagulation and hemostasis of benign vascular and
cutaneous lesions in dermatology including, but not limited to, the following general categories:
• Benign vascular lesions, including port wine stains, hemangiomas, warts, telangiectasia,
rosacea, venous lake, leg veins, spider veins and poikiloderma of Civatte
• Benign cutaneous lesions, including warts, scars and striae
• Benign pigmented lesions, including seborrheic keratoses and nevi
• Chloasma
• Mild to moderate inflammatory acne vulgaris

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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.

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.

Precautions
• Photosensitizing drugs (Tetracyclines, etc.)

Be aware that you may have to adjust the treatment parameters according to clinical
response from test area(s).

• 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/Roaccutan) use

• History of vitiligo

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Expected Transient Events and Possible Adverse Effects

• Erythema, edema and purpura may occur following treatment and typically resolve with
time.
• Hyperpigmentation, hypopigmentation, burns, erosion or blistering may occur, some of
which may result in scarring.
• Itching, bumps, and rash may occur following treatment.
• Deep tissue injury and prolonged wound healing may occur when treating warts.
• Sun exposure, tanning beds, and artificial tanning may increase the risk of side effects and
adverse events.

Treatment Precautions
excel V+ should only be operated by qualified personnel who have received appropriate training. In
addition to the information provided in the Safety and Regulatory section, 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, be sure to fit the patient
with opaque eye protection that will completely block light to the eyes. The eyewear must
provide adequate protection from 532 nm and 1064 nm laser radiation. See the Eye Safety
section of 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
could cause permanent eye damage.

WARNING
Extreme caution should be used when treating near the eyes, taking
care to avoid ocular damage from the treatment beam. Patient eye
protection appropriate for the treatment should be used. The
treatment beam should always be directed away from the eye and
only applied to the skin outside of the orbital rim.

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WARNING
It is essential that all safety precautions as recommended in this
manual be carefully observed, especially with respect to the
wearing of protective eyewear by the patient, practitioner, and
attending staff. In addition, the development of eye-hand-foot
coordination while using the laser system’s handpiece and
footswitch is important to avoid inadvertent laser operation when the
handpiece is removed from the target tissue.

WARNING
The excel V+ system is not intended for hair removal. Using the
excel V+ for hair removal may result in injury to the patient.

CAUTION
It is recommended that the clinical user begin with a low fluence and
observe the tissue 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.

Treatment Information
For treatment-specific guidelines, refer to the excel V+ Treatment Guidelines accompanying this manual.
These guidelines can also be obtained from your local Cutera representative or on the Cutera website.

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.

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Appendix A - Laser Warning Sign

DANGER
INVISIBLE AND VISIBLE LASER RADIATION –
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR
SCATTERED RADIATION. USE PROPER EYEWEAR
WHEN OPERATING AND/OR TREATING PATIENTS.
Output: 13.5 J Max at 532 nm
100 J Max at 1064 nm
Duration: 0.5-40 ms at 532 nm
0.3-60 ms at 1064 nm
Aim Beam: ≤ 1 mW Max at 635 nm
Class 4 Laser Product Per IEC 60825-1:2014
Aim Beam: Class 2

3006927 rA

excel V+ Laser Warning Sign

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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 Laser Emission Indicator Touchscreen display

Cutera-defined Aiming beam adjustment Touchscreen display

Cutera-defined Save/recall settings in memory Touchscreen display

store

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Standard
Symbol Description Location
Reference

Cutera-defined Pulse counter reset Touchscreen display

Cutera-defined Spot size Touchscreen display

Cutera-defined Return to previous screen Touchscreen display

Cutera-defined Go to Information & Adjustment Touchscreen display

screen

Cutera-defined Volume of audible tones and Touchscreen display

indicators

Cutera-defined Touchscreen backlighting Touchscreen display

Cutera-defined System controller software version Touchscreen display

Cutera-defined System handpiece software ver- Touchscreen display

sion

Cutera-defined System display software version Touchscreen display

Cutera-defined Footswitch receptacle Rear panel label

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Standard
Symbol Description Location
Reference

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

cTUVus Mark Rear panel label

IEC 60601-1 Operating temperature range Rear panel label

30°C

15°C

IEC 60601-1 Consult accompanying documents Rear panel label

WEEE Directive Waste of electrical and electronic Rear panel label

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

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Standard
Symbol Description Location
Reference

IEC 60601-1 Type BF equipment Rear panel label

IEC 60825-1 Laser radiation warning Rear panel label and near laser
aperture on CoolView and Gene-
sis V handpieces

21 CFR 801.109 US federal law restricts this device Rear panel label
to sale by or on the order of a prac-
titioner licensed by the law of the
state in which he/she practices to
use or order the use of the device.

IEC 60825-1 Laser aperture Near laser aperture on CoolView

and Genesis V handpieces

IEC 60601-2-22 Laser aperture Near laser aperture on Dermastat

handpiece

IEC 60601-1 Tilting hazard—do not push Side panels

console over obstacle >10 mm
in height

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Appendix C - Bibliography
Anderson RR, Parish JA, Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed
Radiation. Science 1983; 220:524-7.

Groot D, Rao J, Johnston P, Nakatsui T. Algorithm for using a long-pulsed Nd:YAG laser in the treatment of deep
cutaneous vascular lesions. Dermatologic Surgery 2003; 48:76-81.

Omura NE, Dover JS, Arndt KA, Kauvar AN. Treatment of reticular leg veins with a 1064 nm long-pulsed Nd:YAG
laser. Journal of the American Academy of Dermatology 2003, 48(1): 76-81.

Rogachefsky A, Silapunt S, Goldberg D. Nd:YAG laser (1064 nm) irradiation for lower extremity telangiectasias
and small reticular veins: efficacy as measured by vessel color and size. Dermatologic Surgery 2002; 28:220-3.

Sarradet D, Hussain M, Goldberg D. Millisecond 1064-nm Neodymium:YAG laser treatment of facial

telangiectasias. Dermatologic Surgery 2003; 29:56-8.

Tanzi EL, Alster TS. Long-pulsed 1064-nm Nd:YAG laser-assisted hair removal in all skin types. Dermatologic
Surgery 2003; 30(1): 13-7.

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Appendix D - 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 (APAC)
Cutera K.K.
Shibuya Infoss Annex Building, 3rd floor
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

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