Cutera truSculpt User manual

Operator Manual

ii
TRUSCULPT OPERATOR MANUAL
D1395, REV. K, 02/18
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 US federal 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 2018 Cutera, Inc.
Published in USA
D1395
Rev K
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
MDSS GmbH
Schiffgraben 41, D-30175
Hanover, Germany

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The Cutera truSculpt system has been tested and found to comply with the limits for medical devices to
IEC/EN 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. The truSculpt system generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. If the truSculpt system does cause harmful interference to
other devices, which can be verified by turning the console off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the affected equipment and the truSculpt system.
• Connect the affected equipment to an outlet or circuit different from that to which the
truSculpt system is connected.
• Consult the manufacturer or field service technician for help.
The truSculpt system is a high frequency medical device with respect to electrical shock, fire, and
mechanical hazards only in accordance with: IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-4,
and IEC/EN 60601-2-2.

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Contents
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
truSculpt Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
truSculpt Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
truSculpt RF Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
truGlide Massage Roller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Neutral Electrode Cable and Disposable Return Pad. . . . . . . . . . . . . . . . . . . . . . . . . . 4
System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the RF Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Neutral Electrode Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecting the Main Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Filling the Coolant Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Turning On the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Restarting the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Turning Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Emergency Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Display Screens and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Select Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Remaining Uses Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
RF Handpiece Control Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
READY and STANDBY Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Audible Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Information & Adjustment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Selecting Treatment Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Target Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Pulse Duration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Performing an RF Treatment Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Pretreatment Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Applying the Disposable Return Pad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Starting a Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Completing a Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Using the truGlide Roller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Possible Problems and Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
System Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
User Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Cleaning the Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Cleaning the Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Cleaning the Neutral Electrode Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Checking the Water Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Product Complaints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

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SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Protecting Non-target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Electrical Hazard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Classifications and Compliance‘ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
EMC IEC 60601-1-2:2001 Class A Compliance Statement . . . . . . . . . . . . . . . . . . . . 41
System Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Expected Transient Events and Possible Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . 48
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Treatment Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Input Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Output Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Physical Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
System Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
APPENDIX A - SYMBOLS
APPENDIX B - CUTERA DIRECT OFFICE LOCATIONS

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Introduction
The Cutera® truSculpt uses radio frequency (RF) energy to provide topical heating for the purpose of
elevating tissue temperature for body sculpting, body contouring, fat reduction, and circumferential
reduction. In addition, the truGlide massage roller is intended to provide a temporary reduction in the
appearance of cellulite.
The truSculpt consists of a console, a truGlide massage roller, and one or more RF handpieces that
connect to the console with an umbilical cable. All system functions are controlled through the console.
During a treatment cycle, the RF handpiece is placed and held on the skin while RF-generated thermal
energy is delivered. A return pad returns current to the console. At the end of thermal energy delivery, the
handpiece is moved to the next area of skin to be treated and a new cycle is started. If desired, the
truGlide massage roller can be used prior to and/or following RF treatment to massage the entire
treatment area.
This operator manual describes the truSculpt, its operation, and maintenance. If after reviewing this
operator manual you have further questions regarding the truSculpt, contact your local Cutera
representative.
CAUTION
US federal law restricts this device to sale by or on the order of a
practitioner licensed by the law of the state in which he practices to
use or order the use of the device.

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truSculpt Components
The truSculpt consists of a console with a touch screen control panel, one or more RF handpieces, a
truGlide massage roller, a handpiece cradle, and a neutral electrode cable. Other components used for
operation, such as electrical cables and a supply of disposable return pads, are also included.
truSculpt Console
The console consists of the touch screen control panel, handpiece cradle, power supplies, control
electronics, power key switch, and emergency off switch. The touch screen control panel allows you to
adjust treatment parameters and monitor system status.
truSculpt Console with Touch Screen Control Panel