operator manual - mycutera

Operator Manual

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SOLERA TITAN OPERATOR MANUALD1050, REV. C, 6/14

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 USAD1050Revision C

Cutera, Inc.3240 Bayshore BoulevardBrisbane, CA 94005 USA

GMDN: 45223UMDN: 12-346

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Contents

OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Solera Titan System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Footswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Remote Interlock Plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Titan Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Connecting the System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Inspecting the Solera Titan System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Connecting the Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Connecting the Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Inspecting the Titan Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Connecting the Titan Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Connecting the Main Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Turning On the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Restarting the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Turning Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Emergency Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Disconnecting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Preparing the System for Shipment or Transportation . . . . . . . . . . . . . . . . . . . . . . . . 12

Solera Titan Display Screens and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Select Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Handpiece Control Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14


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System Status: STANDBY and READY Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Information & Adjustment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Audible Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Pop-up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Selecting Treatment Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26System Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . . . . . . . . . . . .26Cleaning the System Touchscreen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Cleaning the Titan Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Filling the Coolant Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Remote Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

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

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35Additional Ocular Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37


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Electrical Hazard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Emergency Off Push-Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Emission Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Remote Interlock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Location of Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

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

APPENDIX A - WARNING SIGN

APPENDIX B - SYMBOLS

APPENDIX C - BIBLIOGRAPHY

APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS


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Operation

IntroductionThe 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.

WARNINGAny 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.

WARNINGThe 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 PreparationThe 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 ComponentsThe 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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Touchscreen

Titan handpiece

Handpiece resting tree

Footswitch

Remote interlock plug


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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.

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.

WARNINGAlways 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.

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.

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.

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

Align the Titan handpiececonnector 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.

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

8. Reconnect the main system electrical power.

NOTEWhen 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.

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

Depress and hold bothbuttons


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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.

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.

NOTEThe 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.

Keyswitch


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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.

Emergency Off

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

NOTEWhen 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 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.

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

WARNINGDo not disconnect the Titan handpiece while the system is on.

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


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Moving the System

1. Disconnect the system as described above.

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

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.

CAUTIONAlways 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.

CAUTIONWater 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.

NOTEIf 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.

CAUTIONNever 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.

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

CAUTIONAlways 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.

Pull out to secure

Push in to remove


13

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)

Handpiece Control Screen

Ready buttonStandby button

Fluence display andcontrols


15

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.

WARNINGExcept 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.

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

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

NOTEThere is no aiming beam when using the Solera Titan system.

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


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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 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

Treatment duration indicator


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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

Pulse counter reset button

Emission indicator

Pulse counter

Treatment duration

Remaining exposures


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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

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.

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

Information & Adjustment Screen

Touchscreen backlighting adjustment

Software versions

Titan handpiece ID #

Total pulses recordedfor connected Titan

handpiece

Emission indicatorvolume adjustment


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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 GuideIf 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 beeninterrupted.

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: The footswitch was released before the required treatment duration has elapsed.

Suggestion: 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 GuideCutera 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).

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).

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 “permanent fault”, and the system must be powered off and restarted to clear the code. If this action fails to clear the code, contact your local Cutera representative.

E322 - The water level in the system is low. Add distilled water only.


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Annual System MaintenancePreventive 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.

System RepairSolera 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 ConsoleUse 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.

Cleaning the System Touchscreen Display

Apply an alcohol-based cleaner to a soft cloth to clean the system touchscreen display.

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

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

WARNINGDo 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.

CAUTIONDo not spray or pour cleaning agents directly on the system console or control screen. You may damage the console, touchscreen, and the system electronics.


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Filling the Coolant ReservoirThe 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.

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.

9. Replace the fill cap.

CAUTIONPermanent 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.

NOTEThe coolant capacity of the system is approximately one liter.


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Remote Interlock Pin AssignmentsTo 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 (-)




6 Return Connect to external door switch (+)



Pin 1 8


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


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System SpecificationsSpecifications subject to change without notice.

Treatment Beam

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

Type Infrared Pulsed-light Source

Wavelength 1100 - 1800 nm

Output 100 J Max.

Fluence 5 to 65 J/cm2

Exposure Duration

0.60 to 10.0 seconds

Repetition Rate Single pulse only

Delivery System User-detachable umbilical cable and handpiece

Treatment Spot 1.0 cm x 1.5 cm rectangle

Epidermal Cooling

Sapphire contact window actively maintains epidermal temperature.

System Cooling Self-contained, water to air heat exchanger

Aiming Beam None


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Environmental Requirements

Temperature Operating 5º C to 30º CStorage -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 ProcedureRegulatory 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.

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

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.


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Calibration Instructions

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.

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.

CAUTIONAny work performed by unauthorized personnel will void all warranties.

NOTEThe 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.


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Warranty InformationFor 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 InformationThe 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

IntroductionThe 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 HazardSafety 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.

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.

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.

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

WARNINGThe 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.

WARNINGNever allow anyone without proper protective eyewear near the infrared pulsed-light source while the system is in use.

NOTEA 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.


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Additional Ocular Protection

Additional Safety Considerations

Protecting Non-Target Tissues

WARNINGNever substitute non-laser prescription eyewear for the appropriate laser safety eyewear, as severe damage could occur.

WARNINGUse caution when performing procedures around the eyes. Severe and irreversible eye damage may occur from direct or indirect exposure to treatment beams.

WARNINGNever 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.

WARNINGDo 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.

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

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

WARNINGExcept 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.

WARNINGNever place hands or other objects in the path of the Titan handpiece treatment beam.


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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

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

WARNINGDo 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.

WARNINGThe 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

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

WARNINGNever point the handpiece at reflective objects, such as jewelry or smooth metal surfaces.

WARNINGNever activate the handpiece while pointing the handpiece into free space.

WARNINGDo not leave the system unattended with the key in place.

CAUTIONPrior 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.

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

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

CAUTIONDo 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.

CAUTIONBefore 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

Regulatory ComplianceAll 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.

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

CAUTIONUS 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.

CAUTIONDo 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.


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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.

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.

NOTENo section of the protective system or handpiece housings can be opened without special tools.


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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.

Patents Pending

Cutera, Inc., 3240 Bayshore Blvd., Brisbane CA 94005

Distilled Water Only

3000

687

rev

C

RISK GROUP 3

WARNING: Light emitted may result in eye injury. Do not look at light source.

500-1800 nm150 J max

Per IEC 60601-2-57:2011

USC

Model No: Serial No:

Manufactured On: At:

Solera XXXXXXXXXXXFull month,YYYYBrisbane, CA

Voltage:Current:

Frequency:

100-120V~/200-240V~10A/8A50/60Hz

Solera Titan System Identification Label

System OFFLocated next tothe keyswitch

System ONLocated next tothe keyswitch

Momentary StartLocated next tothe keyswitch


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Electromagnetic CompatibilityThe 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.

WARNINGDo 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.

WARNINGIf 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.

CAUTIONPortable 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 Class B The Solera Titan is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC61000-3-2 Class A

Voltage Fluctuations/flicker emissions IEC61000-3-3

Complies


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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity


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

Electrostatic Discharge (ESD)

IEC61000-4-2

±6kV contact

±8kV air

±2, 4, 6kV contact

±2, 4, 8kV air

Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

IEC61000-4-4

±2kV for power supply lines

±1kV for input/output lines

±2kV line to ground

±1kV line to line

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC61000-4-5

±1kV differential mode

±2kV common mode

±0.5, 1kV

differential mode

±0.5, 1, 2kV

common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions

and voltage variations on power supply

input lines

IEC61000-4-11

<5% Ut (>95% dip in Ut) for 0.5 cycle

40% Ut (60% dip in Ut) for 5 cycles


<5% Ut (>95% dip in Ut) for 5 sec.

<5% Ut (95% dip in Ut) for 0.5 cycle



<5% Ut (>95% dip in Ut) for 5 sec.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Solera Titan requires continued operation during power mains interruptions, it is recommended that the Solera Titan be powered from an uninterruptible power supply or a battery.

Power frequency (50/60Hz)

magnetic field

IEC 61000-4-8

3 A/m N/A Power-frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

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


Immunity Test IEC 60601 Test Level

Compliance Level

Electromagnetic Environment: Guidance

Conducted RF IEC 61000-4-6

Radiated RFIEC 61000-4-3

3 Vrms150kHz to 80 MHz

3V/m80MHz to 2.5 GHz

3 V

3 V/m

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 Distanced = 1.17 √Pd = 1.17 √P 80MHz to 800MHzd = 2.33 √P 800MHz to 2.5GHz

where P is the maximum output power rating 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 power (W) of transmitter

Separation distance (m) according to frequency of transmitter

150 kHz to 80 MHz

d = 1.17 √P

80 MHz to 800 MHz

d = 1.17 √P

800 MHz to 2.5 GHz

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 UseCutera’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 UseContraindications 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 PrecautionsThe 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.

WARNINGNever 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.

CAUTIONIt 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 InformationThe 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 InformationPrior 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

Warning Sign for the Solera Titan

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

3000

411

Rev.

C

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

Symbol Standard Reference Description Location

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


B-2

Cutera-defined Emission indicator Touchscreen display

IEC 60825-1 Remote interlock connector (as defined in 3.67 of IEC 825-1)

Rear panel label

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

Rear panel label

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

Symbol Standard Reference Description Location


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Bibliography1.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 BoulevardBrisbane, CA 94005Telephone: (888) 4-CUTERA or (415) 657-5500Fax: (415) 330-2444Service: (866) 258-8763

Cutera (Japan)

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

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