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.

©June 2014 Cutera, Inc.

Published in USA
D1050
Revision C

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

GMDN: 45223
UMDN: 12-346

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Contents
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Solera Titan System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Footswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Remote Interlock Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Titan Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Connecting the System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Inspecting the Solera Titan System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Connecting the Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Connecting the Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Inspecting the Titan Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Titan Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Main Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Turning On the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Restarting the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Turning Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Emergency Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Disconnecting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Preparing the System for Shipment or Transportation . . . . . . . . . . . . . . . . . . . . . . . . 12
Solera Titan Display Screens and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Select Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Handpiece Control Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

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System Status: STANDBY and READY Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Information & Adjustment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Audible Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Pop-up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Selecting Treatment Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
System Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Cleaning the System Touchscreen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Cleaning the Titan Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Filling the Coolant Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Remote Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Additional Ocular Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

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Electrical Hazard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Emergency Off Push-Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Emission Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Remote Interlock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Location of Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
General Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Expected Transient Events and Possible Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . 48
Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Treatment Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

APPENDIX A - WARNING SIGN

APPENDIX B - SYMBOLS

APPENDIX C - BIBLIOGRAPHY

APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS

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Operation
Introduction
The Solera Titan aesthetic treatment platform employs a user-removable light delivery device handpiece
to perform dermatologic treatments. This operator manual describes the Solera Titan console and its use
and operation with the Titan V and Titan XL handpieces. Refer to the Titan handpiece operator manual
for information regarding the Titan handpieces.

The Solera Titan console and its associated handpieces are precision medical instruments. With proper
handling and operation, they are useful and reliable clinical instruments. If you have any questions
regarding your console or handpieces, contact your local Cutera representative.

WARNING
Any pulsed light emitting device can generate highly concentrated
light which may cause injury if improperly used. To protect patients
and operating personnel, both the console and handpiece operator
manuals, including the Safety and Regulatory sections, should be
carefully read and comprehended before operation.

WARNING
The Titan V and Titan XL handpieces emit optical radiation, which
may result in injury if improperly used. Consult the Titan handpiece
operator manual for a complete description of the use, operation,
indications, and hazards associated with the Titan handpieces.

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System Preparation
The Solera Titan console 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 in-service and training associated with the system and handpiece to ensure
that your staff is experienced with the appropriate performance and safety considerations. Thereafter,
you or the staff at your facility will be performing the daily maintenance routines associated with the
system, including the handpiece used during the procedure (inspecting, cleaning, connecting of the Titan
handpiece), as well as performing basic system safety checks. These procedures are detailed later in
this chapter, in the Maintenance section of this manual, and in the Titan handpiece operator manual.

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

Solera Titan System Components

The Solera Titan system consists of a console, a user-detachable Titan handpiece, a touchscreen control
panel, a footswitch, and a handpiece resting tree. Other components necessary for operation, such as a
remote interlock plug and all electrical cables, are also included.

Console
The Solera Titan console houses the touchscreen control panel, main power keyswitch, emergency off
switch, control electronics, and power supply. The console is the central unit to which the Titan handpiece
is attached. The Titan handpiece is user-detachable. The Titan handpiece is connected to the console
through an umbilical, which enables the 1100 - 1800 nm infrared pulsed-light to be delivered to the
treatment site. The touchscreen control panel allows you to select treatment settings.

Footswitch
The footswitch activates the infrared pulsed-light 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. Use of an external door switch wired to the
remote interlock plug is optional; however, the remote interlock plug must be inserted into the interlock
receptacle whether or not an external door switch is used. The system will remain in STANDBY until the
plug is inserted into the receptacle.

Titan Handpiece
The user-detachable Titan V and Titan XL handpieces are available for use with the Solera Titan console.
All information regarding the Titan handpieces is detailed in the Titan handpiece operator manual.

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Titan handpiece

Touchscreen Handpiece
resting tree

Remote interlock plug

Footswitch

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Connecting the System Components

Inspecting the System Components
Before connecting the Solera Titan system components, inspect the individual components, cables, and
electrical connections for any dirt, debris, or damage. Check all electrical cables to ensure they are not
frayed or split. Inspect the Titan handpiece, as instructed in the Maintenance section of this operator
manual and the Titan handpiece operator manual.

WARNING
Always turn off the system before inspecting the handpiece. Never
look directly into the handpiece even when wearing protective
eyewear. Never look directly into the infrared-pulsed light beam or
point the Titan handpiece towards someone’s eyes or any reflective
surfaces. The infrared pulsed-light delivered by the handpiece can
cause permanent eye damage.

Connecting the Footswitch

Plug the footswitch cable into the footswitch receptacle on the rear of the console. If the footswitch
is not properly connected when the console 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.

Connecting the Remote Interlock Plug

Insert the remote interlock plug into the interlock receptacle on the rear of the console. The remote
interlock plug must be inserted into the interlock receptacle at all times, whether or not an external door
switch is used.

When using an external door switch, the system completely shuts down if the treatment room door is
opened or the remote interlock plug is removed. To resume treatment, close the treatment room door or
reinsert the remote interlock plug, and restart the system using the keyswitch.

Footswitch

Remote interlock plug

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Inspecting the Titan Handpiece

Before connecting the Titan handpiece, inspect the handpiece connector, umbilical cable, handpiece
housing, and patient contact surface for any dirt, debris, or damage.

Connecting the Titan Handpiece

Before connecting the Titan handpiece to the system, ensure that the handpiece resting tree is installed
into its mounting mechanism, which is part of the console, and is locked into place by engaging the
locking tab.

1. Ensure that the console main AC circuit breaker is in the off position.

WARNING
Do not attempt to connect the Titan handpiece while the system is
on.

2. Place the Titan handpiece on the handpiece resting tree.

3. Route the umbilical so it does not encumber the user or patient.

4. Inspect the handpiece, including the pins inside the handpiece connector. Ensure that the
pins are not damaged, bent, or recessed.

5. Align the handpiece connector over the mating connector on the console.

Align the Titan handpiece

connector over this mating
connector

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6. Firmly depress the grey buttons on the handpiece connector, ensuring that the water
connection mechanisms are latched in the open position.

NOTE
When installing or removing the handpiece, ensure that both grey
buttons are firmly depressed. The quick-connect mechanism may
be worn or degraded by repeated handpiece connections if the
buttons are not properly and firmly pressed before either installing
or removing any user-detachable handpiece. The handpiece
connector should be easily and smoothly removed without
significant force required.

Depress and hold both

buttons

7. Gently press the connector downwards to align the fittings. Once aligned, firmly press the
connector downwards until you hear two clicks.

NOTE
It is important to always listen for two clicks when installing the Titan
handpiece. Proper handpiece engagement only occurs when both
clicks are heard.

8. Reconnect the main system electrical power.

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Connecting the Main Power Cable

1. Ensure that the system main power circuit breaker and system keyswitch are in the O (off)
position.

2. Insert the receptacle end of the power cable into the mating AC 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 on the main
electrical service. Ensure that the main power circuit breaker is in the l (on) position.

Main power circuit breaker

AC 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 start-up screen displays, and the system begins a self-test routine. After approximately 10-15
seconds, the system emits an audible tone, and the touchscreen displays the Select Screen. If any fault
conditions, advisory messages, or error codes display on the touchscreen during self-test, refer to the
Troubleshooting section of this operator manual.

NOTE
The Solera Titan system accepts only the Titan V and Titan XL
handpieces. If any other pulsed-light handpiece is connected, an
error will be displayed.

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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 System

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

2. Set the main circuit breaker to the O (off) position.

3. Remove the power plug from the electrical outlet.

4. Remove the footswitch plug from the footswitch receptacle.

5. Disconnect the Titan handpiece.

a. Firmly press and hold both grey buttons on the handpiece connector.

b. Gently lift the connector from the mating connector on the console.

WARNING
Do not disconnect the Titan handpiece while the system is on.

NOTE
It is normal to see a few drops of water at the connector base.

6. Store the Titan handpiece in its designated carrying case.

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Moving the System

1. Disconnect the system as described above.

CAUTION
Always disconnect and store the Titan handpiece when moving the
system any distance other than within one room. The handpiece
may become dislodged from the resting tree when the system is
moved over thresholds or uneven surfaces. Damage will occur to
the handpiece if dropped.

CAUTION
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. Carefully lift and carry the console by placing a hand under the recessed areas in the front
and back of the top cover.

NOTE
If the console is located on a cart, simply lock the wheel locks when
the cart has been placed in a new location. A custom cart for the
Solera Titan system is available from Cutera. Contact your local
Cutera representative regarding the optional Solera Titan system
cart.

3. 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.

CAUTION
Never use the handpiece or umbilical cord to move the system.
Moving the system using the handpiece or umbilical may damage
the handpiece, umbilical, or console.

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Preparing the System for Shipment or Transportation

1. Disconnect the system as described above.

2. Remove the handpiece resting tree from the console top panel by pressing in the locking
latch located near the base of the resting tree.

Pull out to secure

Push in to remove

CAUTION
Always disconnect the system and prepare it for shipment or
transport when moving the system any distance other than within a
single building or facility. When transporting the system in a vehicle
or shipping the system, the handpiece resting tree must be removed
to prevent damage to the resting tree and top cover.

3. Ensure that the fill cap, located at the rear of the console, is securely in place to prevent
water leaks during transport.

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Solera Titan Display Screens and Controls

Select Screen
After the console has been turned ON and the system self-test has been completed, the Select Screen
displays, and the system is automatically placed in STANDBY mode. In STANDBY, the footswitch is
disabled and no treatment light energy is available. Touch the Titan handpiece icon to go to the Titan
Handpiece Control Screen.

Titan handpiece icon

Select Screen

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Handpiece Control Screen

The Handpiece Control Screen is accessed by touching the Titan handpiece icon on the Select Screen.
The Handpiece Control Screen allows you to:

• Select the fluence

• Select the system status (READY or STANDBY)

Fluence display and

controls

Standby button Ready button

Handpiece Control Screen

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System Status: STANDBY and READY Modes

In STANDBY mode, the footswitch is disabled and no treatment beam is available. In READY mode, the
footswitch is enabled and pressing the footswitch produces a treatment light exposure from the
handpiece. The system emits an audible tone to indicate emission with each pulse.

Touch the green READY button in the lower right corner of the Handpiece Control Screen to select
READY mode. When READY mode is selected, the J/cm2 field is outlined in green and the READY
button illuminates.

Touch the yellow STANDBY button in the lower left corner of the Handpiece Control Screen to select
STANDBY mode. When STANDBY mode is selected, the J/cm2 field is outlined in yellow and the
STANDBY button illuminates.

Handpiece Control Screen in STANDBY Mode Handpiece Control Screen in READY Mode

WARNING
Except during actual treatment, the system must always be in
STANDBY mode. Maintaining the system in STANDBY mode
prevents accidental treatment beam exposure if the footswitch is
inadvertently pressed.

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

NOTE
If the console is not used for three minutes, the system will
automatically transition to STANDBY mode.

NOTE
There is no aiming beam when using the Solera Titan system.

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Displays and Indicators

The Solera Titan console and compatible handpieces use the following indicators and controls to ensure
safe and accurate operation:

• Treatment duration indicator.

The treatment duration indicator is a visible indicator on the handpiece that illuminates
at the beginning of a treatment sequence. and remains illuminated during the infrared
radiation exposure and the prescribed period of epidermal cooling. The handpiece
must be held in constant contact with the treatment area for the entire duration
indicated by the treatment duration indicator for proper delivery of treatment energy
and pre- and post-exposure epidermal cooling. An accompanying audible tone
provides a similar indication.

Treatment duration
indicator

• Treatment duration display

The touchscreen displays the treatment duration required for the current fluence
setting. This duration is the amount of time (in seconds) that the handpiece must
remain in contact with the treatment target skin and is equivalent to the time that the
treatment duration indicator on the handpiece remains illuminated.

• Pulse counter display and reset button

The console records and displays the total number of infrared exposures produced
since the last button reset.

• Emission indicator

The emission indicator illuminates when the system is in READY mode, and the
footswitch is pressed.

• Back button

The back button returns the display from the Handpiece Control Screen to the Select
Screen or from the Information Screen to the Select Screen.

• Remaining exposure indicator

The remaining exposures indicator displays the number of exposures remaining for
each Titan handpiece before handpiece replacement is required. When the limit on the
number of exposures that the Titan handpiece is designed to deliver is reached, the

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Handpiece Control Screen is replaced with a large indicator representing the fact that
no further exposures are possible with the handpiece. You can request a replacement
handpiece from the Cutera website.

Back button

Remaining exposures

Treatment duration
Pulse counter

Emission indicator

Pulse counter reset

button

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Information & Adjustment Screen

The Information & Adjustment Screen is accessed by touching the button on the Select Screen. The
Information & Adjustment Screen allows you to:

• Adjust the emission indicator volume

• Adjust the touchscreen backlighting

• View the system software versions

• View the total number of pulses recorded for the connected Titan handpiece

• View the Titan handpiece ID number

Touchscreen backlighting
adjustment

Emission indicator
Software versions
volume adjustment

Titan handpiece ID #

Total pulses recorded

for connected Titan
handpiece

Information & Adjustment Screen

Audible Tones
The Solera Titan system emits a single audible tone with every control screen selection or when an error
condition has occurred. Additionally, audible tones are generated during a treatment exposure sequence,
including during infrared pulsed-light emission.

The volume of the pulsed-light emission indicator can be increased from the minimum setting up to a
volume that can be clearly heard over the system sound level. To adjust the volume of audible tones,
touch the and buttons next to the icon on the Information & Adjustment Screen.

NOTE
The volume cannot be reduced to a point where there is no audible
tone output.

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Pop-up Screen
When the Solera Titan detects an abnormality during self-test or while the system is READY mode, a
pop-up screen displays with a corresponding error code(s) or message. If the error or abnormal condition
is successfully cleared, the pop-up screen can be cleared by touching the “X” in the upper right corner.
Refer to the Maintenance section of this manual for troubleshooting.

Depending upon the fault detected, an animated illustration (e.g., footswitch disconnected or water low)
may display.

Water Low Pop-up Screen

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Selecting Treatment Parameters

Fluence
The only user-selectable Titan handpiece parameter is the Fluence. Fluence is defined as the delivered
optical energy per area at the treatment site and is expressed in units of J/cm2.

Select the desired fluence by touching the and buttons below the J/cm2 display.

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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 the following:

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. Titan handpiece connection. Verify that the handpiece is properly connected and seated
on the handpiece resting tree. If unsure, turn off the system and disconnect and reconnect
the handpiece umbilical, listening for two clicks.

4. Remote Interlock. If the remote interlock plug is used in conjunction with a door switch,
verify that the remote interlock plug is inserted in the remote interlock receptacle. Close
the interlock door.

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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 Titan handpiece is not properly connected.

Suggestion: Verify that the Titan handpiece is properly connected and
seated on the handpiece resting tree. If you are uncertain about
the connection, disconnect and reconnect the handpiece
umbilical, listening for two clicks.

System shuts down during operation with no touchscreen display.

Probable Cause: The building power (main electrical service) has been
interrupted.
Suggestion: Verify and/or turn on the building power.

Probable Cause: The system main power circuit breaker has been tripped.
Suggestion: Place the system main power circuit breaker in the up
position.

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“Water Low” advisory pop-up screen displays on the touchscreen.

Probable Cause: The system is low on water.
Suggestion: Turn off the system and add water, as instructed later in
this chapter. Restart the system to continue with
treatments.

“Footswitch Released” advisory pop-up screen displays on the touchscreen

with error codes 230 and 289
Probable Cause:
Suggestion:
The footswitch was released before the required treatment
duration has elapsed.
Ensure that the footswitch is depressed throughout the
entire treatment duration, as indicated by the treatment
duration indicator on the handpiece and the treatment
duration display on the touchscreen.

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Error code 292 displays on the touchscreen.

Probable Cause: There are only 1000 exposures remaining for the Titan
handpiece.
Suggestion: Clear the error by touching the “X” in the advisory pop-up
screen, and continue using the handpiece until the
remaining exposure indicator reaches zero.

Error code 288 displays on the touchscreen.

Probable Cause: There are no more exposures remaining for the Titan
handpiece.
Suggestion: Clear the error by touching the “X” in the advisory pop-up
screen, and order a replacement handpiece from the
Cutera website.

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Error Code Guide

Cutera aesthetic systems utilize state-of-the-art, self-diagnostic software. In anticipation of or as a result
of a system problem, an error code displays in an advisory pop-up screen on the touchscreen. Some of
these codes serve as a warning and many are clearable by simply touching the “X” in the advisory pop-
up window. Some conditions require service by an authorized Cutera Service Representative.

Below is a brief explanation of some of the codes that may display in the advisory pop-up screen. If you
have any questions about this information or the operation and service of your system, contact your local
Cutera representative (see Appendix D).

Error Code Series/Description Error Code Example

Series 200 Codes - Series 200 codes are “user
clearable” faults and must be cleared to resume
treatments. To clear, touch the “X” in the advisory
pop-up screen on the touchscreen. If after touching
the “X” the code does not clear, power off and re-
start the system.
Code 250 - An attempt was made by the user to
enter the READY mode while the footswitch was
depressed. Release the footswitch and press the
READY button.

Series 300 Codes - Series 300 codes indicate a E322 - The water level in the system is low. Add
“permanent fault”, and the system must be distilled water only.
powered off and restarted to clear the code. If this
action fails to clear the code, contact your local
Cutera representative.

If any error codes or symptoms occur that are not addressed in the troubleshooting guide, or if the
suggested solutions do not resolve the problem, contact your local Cutera representative (see Appendix
D).

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Annual System Maintenance

Preventive maintenance, safety, power, and calibration checks should be performed annually (or every 6
months if the system has not been in use) by a Cutera representative to ensure proper performance.

NOTE
The system console and handpieces should not be stored long term
with water in the system.

System Repair
Solera Titan systems in the United States are repaired at the factory. Contact your local Cutera office to
make arrangements for repair and for terms and conditions. Solera Titan system owners located outside
of the United States should contact their local Cutera office for instructions.

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 pulsed-light 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.

Cleaning the Titan Handpiece

Refer to the Titan handpiece operator manual for information on the care of your Titan handpiece.

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Filling the Coolant Reservoir

The Solera Titan console requires clean distilled water. Consoles are delivered with no coolant 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. A container 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:

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. When 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 liter.

9. Replace the fill cap.

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Remote Interlock Pin Assignments

To connect an external door switch to the remote interlock plug, you must wire an RJ45 plug (included
with the console) to connect the external door switch using the pin assignments from the table below.
The external door switch should be arranged such that in the “closed door” state, the switch is closed or
shorted.

Pin Signal Name Signal Description

1 None No Connection

2 Remote Interlock Connect to external door switch (-)

3 None No Connection

4 None No Connection

5 None No Connection

6 Return Connect to external door switch (+)

7 None No Connection

8 None No Connection

Pin 1 8

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Electrical Utilities
The Solera Titan system employs an auto-tap selection feature, which allows electrical power
connections to be made without any manual configuration change to the electrical mains. The connection
to the building electrical supply simply requires that the two line wires in the electrical power cable be
connected to the building power (both have live voltages). The green/yellow wire must be connected to
ground.

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. Such a connection will ensure
compliance with allowable leakage current levels per UL2601 for this device. Leakage current for these
systems does not exceed 500 A.

If the 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.

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 Infrared Pulsed-light Source

Wavelength 1100 - 1800 nm

Output 100 J Max.

Fluence 5 to 65 J/cm2

Exposure 0.60 to 10.0 seconds

Duration

Repetition Rate Single pulse only

Delivery System User-detachable umbilical cable and

handpiece

Treatment Spot 1.0 cm x 1.5 cm rectangle

Epidermal Sapphire contact window actively maintains

Cooling epidermal temperature.

System Cooling Self-contained, water to air heat exchanger

Aiming Beam None

Physical Parameters
Size (W X L X H): 13.5 in. x 15 in. x 20 in. (.35 m x .38 m x .51 m)

Weight: 50 lbs. (22.7 kg.)

Operating length of umbilical: 6.5 ft. (2.13 m)

Minimum bend Storage 5 in. (127 mm)

radius of umbilical: Momentary 2 in. (50 mm)

Electrical Requirements
Voltage, Current 100-120 V~/200-240 V~, 10A/8A

Frequency 50/60 Hz

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Environmental Requirements
Temperature Operating 5º C to 30º C
Storage -10º C to 50º C (coolant drained)

Humidity 0 to 90%, non-condensing

Max. Heat Dissipation 1200 Watts

Max. Altitude Operating 15,000 ft.

Non-operating 50,000 ft.

Classifications
FDA Classification Class II Medical Device

CDRH Classification Infrared Heat Source per 21 CFR 890.550

IEC 60601-2-57 Classification Risk Group 3

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Calibration Procedure
Regulatory agencies require that manufacturers of US FDA CDRH Class III and IV and IEC 60825-1
Class 3 and 4 medical lasers supply their customers with power calibration instructions.

While the Solera Titan system is not a laser, and customers are not able to alter the calibration of the
Solera Titan system, instructions for verifying proper calibration are included here.

Calibration of the Titan handpiece optical output should be checked periodically. With proper care under
normal operating conditions, Cutera recommends that the calibration be checked every 12 months to
ensure that the energy output delivered from the handpiece(s) corresponds accurately to the user-
selected settings. The following procedure should also be performed after any service or repair work.

DISCLAIMER WARNING
Adjustment or alteration to the Solera Titan system is a service
procedure to be performed only by a Cutera-certified Service
Engineer or at the Cutera factory. Adjustments by anyone other than
a trained Cutera Service Engineer voids any existing
manufacturer’s warranty on the instrument. A service manual for
your appropriate console platform 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 pulsed-

infrared light equipment. Questions regarding this procedure should be referred to your local Cutera
representative.

Equipment Required
Energy meter (Ophir Nova display unit model with L40-150A-SH LP* programmed 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).

* LP = Long Pulse

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Calibration Instructions

CAUTION
Any work performed by unauthorized personnel will void all
warranties.

1. Set up the energy meter in a convenient location so that the sensor head can be easily
reached with the Titan handpiece, and set the meter display unit to the ENERGY mode.

2. Place the Titan handpiece tip in front of the energy meter sensor head.

NOTE
The distance must be no further than 2 mm from the energy meter
sensor to the sapphire window. The surface of the sapphire window
must be oriented parallel to the meter sensor surface.

3. Power on the system.

4. Select the lower fluence range.

5. Place the system in READY mode.

6. Fire a single shot in the energy meter.

7. Record the reading on the energy meter.

The energy reading when divided by 1.5 should be equal to the fluence setting within
±20% of the requested fluence.

8. Repeat steps 5 through 8 for the highest fluence setting that is selectable for the
handpiece.

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Warranty Information
For specific and detailed warranty information for your Cutera console and handpiece(s), refer to the first
page of your purchase “Agreement” and the last page of the “Terms and Conditions of Sale”.

End of Life Disposal - Environmental Information

The Solera Titan 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. Contact the manufacturer or other authorized disposal company to decommis-
sion your equipment.

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Safety and Regulatory

Introduction
The Solera Titan console and Titan handpiece, when properly used by trained personnel, are safe and
effective instruments for indicated clinical treatments. Keep in mind that safe operation requires a
thorough understanding of the system and safety features as described in this operator manual and in
the Titan handpiece operator manual.

Users must take precautions to prevent exposure of infrared pulsed-light 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. Infrared pulsed-light
treatment information is provided as a guide. Individual treatments should be based on clinical training,
clinical observation of infrared pulsed-light tissue interaction, and appropriate clinical endpoints.

Optical Hazard
Safety eyewear is routinely required with pulsed-infrared light systems. Personnel responsible for 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 each of the available pulsed-light emissions and the configuration of the treatment room (usually
within the controlled area). For additional information, refer to ANSI Z136.1-2007, ANSI Z136.3-2005, or
IEC 60825-1:2007, Annex A.

The Solera Titan console is a Class II medical device as defined by the U.S. Code of Federal Regulations
and a Risk Group 3 device as defined by IEC 60601-2-57.

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The Solera Titan console is a near-infrared pulsed-light source per 21 CFR 890.550. As such, the
console itself is not subject to ANSI Z136.1 standards. However, Cutera recommends that practitioners
maintain a safe working distance and that safety eyewear be worn. Specifically, recommended eyewear
protects against inadvertent infrared pulsed-light exposure. For specific values, see “Eyewear
Specifications” in the Safety and Regulatory section of the Titan handpiece operator manual.

WARNING
The infrared pulsed-light produced by this system contains invisible
(1100 - 1800 nm) light that can cause permanent eye damage.
Cutera does not recommend looking directly into the handpiece,
even when wearing protective eyewear, or looking directly into the
pulsed-infrared light or at scattered light from metallic or other
reflective surfaces. Both direct and reflected infrared pulsed-light
may contain sufficient energy to cause permanent eye damage.

All personnel operating or located in the vicinity of a Cutera aesthetic system, including the patient, staff
personnel, and observers, should wear protective eyewear with sufficient protection (optical density or
shade factor specified in the Titan handpiece operator manual, or greater) for the appropriate wavelength
range of the handpiece. 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
infrared pulsed-light source while the system is in use.

In addition to providing the required infrared pulsed-light safety eyewear, take the following steps to
secure the treatment room or controlled treatment area:

1. Alert personnel by posting an appropriate warning sign on the outside of the treatment
room door when the system is in use.

2. Close the treatment room door during operation of the system.

3. Install 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 infrared pulsed-light 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.

The user must protect the patient’s eyes with appropriate eyewear.

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

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.

CAUTION
The Solera Titan console and Titan handpieces are intended solely
for licensed practitioners trained in their proper use.

CAUTION
Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous infrared
radiation exposure.

Protecting Non-Target Tissues

WARNING
Except during actual treatment, the system must always be in
STANDBY mode. Maintaining the system in STANDBY mode
prevents accidental infrared pulsed-light exposure if the footswitch
is inadvertently pressed.

WARNING
Never place hands or other objects in the path of the Titan
handpiece treatment beam.

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CAUTION
To prevent accidental infrared pulsed-light discharge, always turn off
the system before connecting or disconnecting the Titan handpiece.

Electrical Hazard
• High voltages are present inside the system. Do not remove the exterior housing.
• Only an authorized Cutera Service Representative should perform the service on the
system.
• Do not attempt to perform maintenance other than that which is outlined in this manual.
• Maintenance should only be performed with the system turned off and disconnected from
the power source.
• 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 Safety

WARNING
Do not allow untrained or unqualified personnel to use the system at
any time.

WARNING
Never point the handpiece at reflective objects, such as jewelry or
smooth metal surfaces.

WARNING
Never activate the handpiece while pointing the handpiece into free
space.

WARNING
Do not leave the system unattended with the key in place.

CAUTION
Prior to each use of the system, inspect all protective eyewear,
cables, and handpieces for any damage, excessive wear, or
crimping that could affect system performance or safe operation.

CAUTION
Do not place any unnecessary stress on the umbilical cable (i.e., by
pulling, tightly bending, or twisting handpiece).

CAUTION
Always verify that the treatment parameters are correct before
placing the system in READY.

CAUTION
Do not leave the system in READY mode when not in use. Always
place the system in STANDBY between treatments or when
treatments are not being performed.

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

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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
thoroughly read this manual and the Titan handpiece operator
manual.

Regulatory Compliance
All Cutera aesthetic platforms are 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, IEC 60601-1, IEC 60601-
1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1

Cutera pulsed-light devices are also designed to comply with IEC 60601-2-57.

Location of Controls
Operation and adjustment controls are located so that the user need not be exposed to infrared pulsed
light 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 infrared pulsed-light emission by pushing the
red, mushroom-shaped emergency-off button that is located next to the keyswitch. Following emergency
shutoff, the keyswitch must be used to restart the system.

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Emission Indicator
When the system is turned on, controls and indicators appear on the touchscreen after a self-test. When
the self-test is complete, the system defaults to STANDBY mode and the Titan handpiece icon appears
in the display. 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 emission icon will turn yellow.

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 disable the console if the treatment room door is opened.

Protective Housing
The Solera Titan console has protective housings that prevent unintended human access to infrared
pulsed-light radiation. The housing must be opened only by a Cutera-certified representative.

NOTE
No section of the protective system or handpiece housings can be
opened without special tools.

Audible Emission Indicator

Each pulsed-light emission delivered is accompanied by an audible tone.

Manual Reset
If the system shuts down during operation (e.g., due to electrical power loss or depression of the
emergency off button), the system must be manually restarted using the key switch to resume operation.
The system internal memory will recall the most recent operating parameters upon restart.

Fault Detection Circuitry

If the system detects a fault condition, treatment beam exposure cannot occur. The high voltage power
supply is turned off, and the footswitch is disabled.

Some fault conditions may be cleared by the operator. Refer to the Troubleshooting Guide in this manual
for additional information.

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Location of Regulatory Compliance Labels

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

Distilled Water Only

RISK GROUP 3
WARNING: Light emitted may result in
eye injury. Do not look at light source.
Patents Pending 500-1800 nm
150 J max
Per IEC 60601-2-57:2011

C US

3000687 rev C
Model No: Solera XXXXX Voltage: 100-120V~/200-240V~
Serial No: XXXXXX Current: 10A/8A
Manufactured On: Full month,YYYY Frequency: 50/60Hz
At: Brisbane, CA
Cutera, Inc., 3240 Bayshore Blvd., Brisbane CA 94005

Solera Titan System Identification Label

System OFF
Located next to
the keyswitch
Momentary Start
Located next to
the keyswitch

System ON
Located next to
the keyswitch

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Electromagnetic Compatibility
The Solera Titan complies with IEC 60601-1-2 (Edition 3) requirements for EMC with other devices. Like
other electrical medical equipment, the Solera Titan requires special precautions to ensure
electromagnetic compatibility (EMC) with other electrical medical devices. To ensure electromagnetic
compatibility, the Solera Titan must be installed and operated according to the EMC information provided
in this manual.

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

WARNING
If the Solera Titan is used adjacent to or stacked with other
equipment, observe and verify normal operation of the system 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
Solera Titan.

CAUTION
Portable and mobile RF communications equipment may affect the
normal function of the Solera Titan.

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

The Solera Titan is intended for use in the electromagnetic environment specified below. The customer or the
user of the Solera Titan should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic Environment: Guidance

RF emissions CISPR 11 Group 1 The Solera Titan uses RF energy only for
internal function; therefore, RF emissions
are very low and are not likely to cause
any interference in nearby electronic
equipment.

RF emissions CISPR 11
Harmonic emissions IEC61000-3-2
Voltage Fluctuations/flicker
emissions IEC61000-3-3
Class B The Solera Titan is suitable for use in all
establishments, including domestic
Class A establishments and those directly
connected to the public low voltage
Complies
power supply network that supplies
buildings used for domestic purposes.

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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The Solera Titan is intended for use in the electromagnetic environment specified below. The customer or the
user of the Solera Titan should ensure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment:
Guidance

Electrostatic ±6kV contact ±2, 4, 6kV contact Floor should be wood, concrete, or
Discharge (ESD) ceramic tile. If floors are covered with
±8kV air ±2, 4, 8kV air synthetic material, the relative humidity
IEC61000-4-2 should be at least 30%.

Electrical fast ±2kV for power ±2kV line to ground Mains power quality should be that of a
transient/burst supply lines typical commercial or hospital
±1kV line to line environment.
IEC61000-4-4 ±1kV for input/output
lines

Surge ±1kV differential ±0.5, 1kV Mains power quality should be that of a
mode typical commercial or hospital
IEC61000-4-5 differential mode environment.
±2kV common mode
±0.5, 1, 2kV

common mode

Voltage dips, <5% Ut (>95% dip in <5% Ut (95% dip in Mains power quality should be that of a
short interruptions Ut) for 0.5 cycle Ut) for 0.5 cycle typical commercial or hospital
and voltage environment. If the user of the Solera
variations on 40% Ut (60% dip in 40% Ut (60% dip in Titan requires continued operation
power supply Ut) for 5 cycles Ut) for 5 cycles during power mains interruptions, it is
input lines recommended that the Solera Titan be
70% Ut (30% dip in 70% Ut (30% dip in powered from an uninterruptible power
IEC61000-4-11 Ut) for 25 cycles Ut) for 25 cycles supply or a battery.

<5% Ut (>95% dip in <5% Ut (>95% dip in

Ut) for 5 sec. Ut) for 5 sec.

Power frequency 3 A/m N/A Power-frequency magnetic fields should

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

NOTE: Ut is the a.c. mains voltage prior to application of the test level.

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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The Solera Titan is intended for use in the electromagnetic environment specified below. The customer or the
user of the Solera Titan should ensure that it is used in such an environment.

Immunity Test IEC 60601 Test Compliance Electromagnetic Environment: Guidance

Level Level

Portable and mobile RF communications

equipment should be used no closer to any
part of the Solera Titan, including its cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.

Recommended Separation Distance

d = 1.17 √P
Conducted RF 3 Vrms 3V d = 1.17 √P 80MHz to 800MHz
IEC 61000-4-6 150kHz to 80 MHz d = 2.33 √P 800MHz to 2.5GHz

Radiated RF 3V/m where P is the maximum output power rating

IEC 61000-4-3 80MHz to 2.5 GHz 3 V/m of the transmitter in watts (W) according to
the transmitter manufacturer 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
Solera Titan is used exceeds the applicable RF compliance level above, the Solera Titan should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the Solera Titan.

(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 Solera Titan

The Solera Titan is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The user of the Solera Titan can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the Solera
Titan as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output Separation distance (m) according to frequency of transmitter

power (W) of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.17 √P d = 1.17 √P d= 2.33 √P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d)
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

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Clinical Applications
General Indications for Use
Cutera’s Solera Titan platform and Titan handpieces are intended to emit energy in the infrared spectrum
to provide topical heating for the purpose of elevating tissue temperature for:

• the temporary relief of minor muscle and joint pain and stiffness

• the temporary relief of minor joint pain associated with arthritis

• the temporary increase in local circulation where applied

• the relaxation of muscles

In addition, the Solera Titan system may also help muscle spasms, minor sprains and strains, and minor
muscular back pain.

Contraindications for Use

Contraindications for use:

• Pregnant patients

• Patients undergoing treatment for skin cancer

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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/Roaccutane) use

• History of vitiligo

Expected Transient Events and Possible Adverse Effects

• DISCOMFORT/ PAIN - Some discomfort may be experienced during treatment. Pain may
include the feeling of burning, stinging and radiating pain.

• REDNESS/SWELLING/BRUISING - Short term redness (erythema) or swelling (edema) of

the treated area is common and may occur. There also may be some bruising.

• SKIN COLOR CHANGES - During the healing process, there is a possibility that the treated
area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color
compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may
be permanent.

• WOUNDS - Treatment can result in burning, blistering, or bleeding of the treated areas.

• INFECTION - Infection is a possibility whenever the skin surface is disrupted, although

proper wound care should prevent this.

• SCARRING - Scarring is a rare occurrence, but it is a possibility if the skin surface is

disrupted.

• SUN EXPOSURE/TANNING BEDS/ARTIFICIAL TANNING - May increase risk of side

effects and adverse events.

• EYE EXPOSURE - Failure to wear protective eyewear during the entire treatment may
cause severe and permanent eye damage.

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Treatment Precautions
The Solera Titan console 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 during use of the Solera Titan system:

• Guard against accidental exposure to pulsed light energy.

• Instruct all staff members to carefully direct 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 light at the wavelengths being used. See “Eyewear
Specifications” in the Safety and Regulatory section of the Titan handpiece operator manual
for protective eyewear requirements.

• Instruct all staff members and patients to never look directly at the pulsed-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 pulsed-light
exposure could cause permanent eye damage to either the user or
the patient.

CAUTION
It is recommended that the clinical user begin with a low fluence and
observe the epidermal response (skin color) in the treated area
before increasing the fluence. Increasing the fluence will provide
increased heating. However, it may also increase the chance of
unwanted epidermal damage (see possible adverse events in the
previous section of this manual). The patient should feel a
continuing warmth in the area being treated, but should not feel
uncomfortably hot.

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Treatment Information
The Solera Titan console with the Titan handpiece can be used to provide heating of the skin. Dermal
heating is provided by the emitted infrared light, which is absorbed by water in the skin and converted to
heat. The infrared light is emitted through a sapphire window in contact with the epidermis. This window
helps to prevent epidermal damage by conducting heat from the outer surface of the skin.

For treatment-specific guidelines, refer to the 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, paying close attention to potential contraindications. At this time, the
user should also discuss all potential benefits, complications, options and risks of treatment.

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Warning Sign

DANGER
DANGER: PULSED LIGHT DEVICE.
VISIBLE TO INFRARED LIGHT.
USE PROPER EYEWEAR WHEN
OPERATING AND/OR TREATING
PATIENTS.

3000411 Rev. C
Warning Sign for the Solera Titan

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Symbols
This appendix describes the system symbols and their meanings for all Cutera product platforms.

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

DIN 18734 Fluence (J/cm2) Touchscreen display

DIN 18734 Pulse counter reset Touchscreen display

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Standard
Symbol Description Location
Reference

Cutera-defined Emission indicator Touchscreen display

IEC 60825-1 Remote interlock connector Rear panel label

(as defined in 3.67 of IEC 825-
1)

Cutera-defined Footswitch receptacle Rear panel label

IEC 60601-1 Type BF equipment Rear panel label

TUV Mark Rear panel label

IEC 60601-1 Refer to instruction manual Rear panel label

WEEE Directive Waste of electrical and Rear panel label

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

IEC 60601-2-57 Optical radiation warning Rear panel label

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

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Cutera Direct Office Locations

Cutera World Headquarters
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005
Telephone: (888) 4-CUTERA or (415) 657-5500
Fax: (415) 330-2444
Service: (866) 258-8763

Cutera (Japan)
Cutera K.K.
Shibuya Infoss Annex Bldg, 3rd fl.
12-10 Sakuragaoka
Shibuya-ku, Tokyo 150-0031
Tel: +81 (0) 3 5456 6325
Fax: +81 (0) 3 5456 2213

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