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

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truSculpt RF Handpieces
Two RF handpieces are available for use with the truSculpt: truSculpt 16, which features a 16 cm2
concave electrode, and truSculpt 40, which features a 40 cm2 concave electrode. The RF handpieces
deliver RF energy to the skin and subcutaneous tissue during treatment.
The handpiece on/off button activates, pauses and deactivates the treatment cycle. Colored LED lights
on the handpieces illuminate to indicate the following:
• dull green light = communication between handpiece and system software has been
established
• bright green light = system is in READY mode
• bright blue light = RF energy is being delivered
• bright red light = system has encountered an error
truSculpt 16 RF Handpiece
truSculpt 40 RF Handpiece
On/off button
LED lights
Curvature indicator
On/off button
LED lights
Curvature indicator

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truGlide Massage Roller
The truGlide massage roller provides temporary reduction in the appearance of cellulite. The truGlide
can be rolled over areas where cellulite appears to provide smoother looking skin.
truGlide Massage Roller
Neutral Electrode Cable and Disposable Return Pad
The neutral electrode cable connects to a disposable return pad1. The return pad is intended to safely
return the RF current from the patient back to the system through the neutral electrode cable.
1. Bovie® ESRE-1 Disposable Split Adult Return Electrode
CAUTION
Cutera provides a supply of disposable return pads with each
truSculpt system or replacement RF handpiece. To ensure safe
system operation, use only Cutera-supplied return pads.
Neutral Electrode Cable
Disposable Return Pad

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System Installation
The truSculpt is shipped directly from the factory to your site. It is important that your staff be experienced
with the appropriate performance and safety considerations. Training associated with the system and
handpieces is available. Contact Cutera for information.
Remove the components from the shipping crate, and verify that all items have been received and are
not damaged. Save all containers and packaging material; they will be required if it is necessary to return
the equipment.
To set up the system you will need to:
• connect the RF handpiece
• connect the neutral electrode cable
• connect the main power cable
• insert the key
• fill the coolant reservoir
Refer to the following sections for detailed system installation instructions.
Connecting the RF Handpiece
Only one RF handpiece can be connected to the console at a time. Store the unused handpiece(s) in the
appropriate case.
NOTE
Do not remove the protective tape covering the two USB ports
(behind the keyswitch). The USB ports are for service use only, and
only Cutera Service personnel shall remove the protective tape.
WARNING
Before connecting the handpiece, inspect the handpiece housing,
umbilical cable, umbilical connector, and RF electrode for dirt,
debris, or damage. Ensure that the pins inside the umbilical
connector are not damaged, bent, or recessed.
WARNING
Never disconnect the RF handpiece while the system is turned on.
Damage to the power supply may occur. Always turn off the system
and wait for approximately 30 seconds before disconnecting the
handpiece.

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1. Place the RF handpiece in the handpiece cradle.
2. Route the umbilical cable so that it does not interfere with the operator or patient.
3. Align the umbilical connector over the receptacle on the top console cover.
4. Firmly depress the two buttons on either side of the umbilical connector, and gently press
the connector downwards to align the fittings. Press firmly until you hear two clicks.
CAUTION
To ensure proper handpiece engagement, always listen for two
clicks when installing the RF handpiece.
Buttons

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Connecting the Neutral Electrode Cable
Plug the neutral electrode cable connector into the neutral electrode cable receptacle on the side of the
RF handpiece umbilical connector.
Neutral Electrode Cable Receptacle
WARNING
Before connecting the neutral electrode cable, inspect the cable for
damage. If it is damaged, do not use the cable and contact Cutera
Service.
Neutral electrode cable
receptacle

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Connecting the Main Power Cable
1. Ensure that the console’s main power circuit breaker and key are in the (OFF) position.
2. Plug the main power cable into the main power receptacle located on the rear of the
console. Plug the opposite end of the cable into the power outlet.
3. Set the circuit breaker to the (ON) position.
Main Power Receptacle and Circuit Breaker
Main power
circuit breaker
Main power
receptacle

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Filling the Coolant Reservoir
The truSculpt console requires clean distilled water as a coolant. The coolant reservoir is located on the
rear of the console. Occasionally, distilled water may need to be added to top off the reservoir.
1. Turn off the system.
2. Remove the reservoir cap, and carefully fill the reservoir to the fill line using clean, unused
distilled water. Do not overfill.
Coolant Reservoir
CAUTION
Permanent damage to internal components will occur if improper
coolant is used. A container of distilled water is shipped with every
system. Under no circumstance should tap water or any liquid other
than distilled water be used.
Coolant reservoir

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3. Turn the key to the (START) position, then release.
Turning on the system engages the pump, allowing the water to be drawn into the cooling
system.
4. Allow the system to run for 5 to 10 seconds.
5. Turn the key to the (OFF) position.
6. Carefully top off the reservoir.
7. Repeat steps 3 through 6 until the reservoir is full.
8. Replace the reservoir cap.
NOTE
The coolant capacity of the system is approximately 1 liter.

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System Basics
Turning On the System
1. Insert the key into the keyswitch.
2. Turn the key to the (START) position, hold for a full second, then release. Upon
release, the key automatically springs back to the (ON) position.
Keyswitch
The start-up screen appears, and the system begins a self-test routine. After approximately 10–15
seconds, the system emits an audible tone, the Select screen appears, and the system is automatically
placed in STANDBY mode. In STANDBY mode, the RF handpiece on/off button is disabled and no
treatment energy is available.
If a fault condition, advisory message, or error code appears in the pop-up display during the self test,
refer to the Troubleshooting Guide section in the Maintenance chapter.
NOTE
The system can only be turned on with the power key. The key
cannot be removed while in the (ON) position or the (START)
position, and the system will only operate with the key in place.
When treatments are complete or the system is not in use, always
remove and store the key.

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Restarting the System
In the event of a fault condition, you may need to restart the system.
1. Turn the key to the (OFF) position.
2. Wait 5 seconds before turning the key to the (START) position. Release the key. The
system will go through the normal start-up sequence.
Turning Off the System
Under normal operating conditions, turn the key to the (OFF) position.
When the main power cable is connected to the electrical outlet, some internal circuits remain energized.
To de-energize all the internal circuits, turn off the main power circuit breaker and disconnect the power
cord from the power outlet.
Emergency Off
In an emergency or to immediately shut down the system, press the red Emergency OFF button.
Following an emergency shutdown, the key must be used to restart the system.
Emergency OFF Button
Manual Reset
If the system shuts down during operation (due to electrical power loss or depression of the Emergency
OFF button), you must manually restart the system using the key. The system internal memory will recall
the most recent operating parameters upon restart.
Emergency OFF button