excel hr operator manual international customers - cutera

Operator Manual

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 per-mission 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 lan-guage.

Please note that while every effort has been made to ensure that the data given in this docu-ment 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.

©December 2017 Cutera, Inc. Published in USA D2161 Revision A

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

MDSS GmbH Schiffgraben 41, D-30175 Hannover, Germany

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

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EXCEL HR OPERATOR MANUAL D2161, REV. A, 12/17

Contents

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

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Characteristics of the 755 nm Alexandrite Laser Beam . . . . . . . . . . . . . . . . . 1Characteristics of the 1064 nm Nd:YAG Laser Beam . . . . . . . . . . . . . . . . . . . 2

System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Verifying the Integrity of the Delivery System . . . . . . . . . . . . . . . . . . . . . . . . . 2System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

System Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Connecting the System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Connecting the Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Inserting the Remote Interlock Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Connecting the Main Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Turning On the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Restarting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Turning Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Emergency Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Disconnecting the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Display Screens and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

ii


Select Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Treatment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Information & Adjustment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13System Status: STANDBY and READY Modes . . . . . . . . . . . . . . . . . . . . . . 14Aiming Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Memory Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Displays and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Audible Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Pop-up Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

User-selectable Treatment Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Selecting the Laser Wavelength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Selecting the Fluence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Selecting the Pulse Width (1064 nm only) . . . . . . . . . . . . . . . . . . . . . . . . . . 23Selecting the Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Selecting the Spot Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Selecting the Temperature of the Sapphire Cooling Window . . . . . . . . . . . . 25

Cleaning the Handpiece During Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Treatments without gel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Treatments with gel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Error Code Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Annual System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

System Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Routine User Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Cleaning the External Surfaces of the System Console . . . . . . . . . . . . . . . . 34Cleaning the System Touchscreen Display. . . . . . . . . . . . . . . . . . . . . . . . . . 34Inspecting and Cleaning the Heat Exchanger Intake . . . . . . . . . . . . . . . . . . 35Filling the Coolant Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Inspecting and Cleaning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Inspecting and Cleaning the Handpiece Holster . . . . . . . . . . . . . . . . . . . . . . 42

Remote Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Electrical Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Treatment Beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Physical Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Maximum Allowable Temperature of Accessible Parts . . . . . . . . . . . . . . . . . 45Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Eyewear Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

755 nm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 461064 nm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

End of Life Disposal - Environmental Information . . . . . . . . . . . . . . . . . . . . . . . . 48

SAFETY AND REGULATORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Optical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Additional Ocular Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Additional Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Electrical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Operational Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Operational Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Emergency Off Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Laser Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Location of Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . 59

Regulatory Compliance Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

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Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

CLINICAL APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

General Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

755 nm Alexandrite Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 671064 nm Nd:YAG Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Expected Transient Events and Possible Adverse Effects. . . . . . . . . . . . . . . . . . 69

Treatment Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

APPENDIX A - LASER WARNING SIGN

APPENDIX B - SYMBOLS

APPENDIX C - CUTERA DIRECT OFFICE LOCATIONS

1


Operation

IntroductionThe Cutera excel HR is a dual-wavelength (755 nm Alexandrite and 1064 nm Nd:YAG) laser system that treats a wide range of dermatologic conditions requiring selective photothermolysis of target chromophores. This operator manual describes the use and operation of the excel HR, including the permanently attached handpiece.

Cutera lasers and handpieces are precision medical instruments. They have undergone extensive testing and, with proper handling, are useful and reliable clinical instruments. If you have any questions regarding your laser and/or handpiece(s), contact your local Cutera representative.

Any laser device can generate highly concentrated light, which may cause injury if improperly used. To protect patients and operating personnel, read and comprehend this entire operator manual, including the Safety and Regulatory chapter, before operation.

Characteristics of the 755 nm Alexandrite Laser Beam

The 755 nm laser wavelength falls in the near infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye; therefore, a low power, visible aiming beam that is coaxial with the invisible treatment beam is used to target tissue. The Alexandrite laser light is absorbed by hemoglobin and melanin in target tissues. This makes the 755 nm laser useful for treating multiple indications. See the Clinical Applications section for specific Indications for Use for the 755 nm wavelength.

WARNING

2


Characteristics of the 1064 nm Nd:YAG Laser Beam

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

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

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

Verifying the Integrity of the Delivery System

The aiming beam is coaxial with the treatment beam and, therefore, provides a good means of verifying the integrity of the delivery system (i.e., handpiece and umbilical cable). Verify the integrity of the delivery system daily to ensure that it is not damaged or malfunctioning.

After turning on the system, place it in READY mode, and direct the aiming beam at a non-reflective surface. If the aiming beam is not present at the distal end of the handpiece, if its intensity is reduced, or if it looks diffused, then the handpiece and/or cable may be damaged or malfunctioning. Do not use the handpiece; contact Cutera Service (refer to Appendix C).

3


System ComponentsThe excel HR consists of a system console with a boom and handpiece holster, a handpiece and a footswitch. Other components necessary for operation, such as an external door interlock plug and all electrical cables, are also included.

System Console

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

Handpiece

The handpiece delivers laser energy from the system console to the treatment site and provides epidermal cooling. The handpiece is permanently attached to the system console with an umbilical cable.

Footswitch

The footswitch activates the treatment beam.

Remote Interlock Plug

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

Footswitch

Remote interlock plug

Holster

System console

Boom

Handpiece

4


5


Connecting the System ComponentsBefore connecting the 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 handpiece, as instructed in the Maintenance chapter of this manual.

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 treatment beam or at scattered light from metallic or other reflective surfaces. Doing so can cause permanent eye damage.

Connecting the Footswitch

Plug the footswitch cable into the footswitch receptacle on the rear of the system console. If the footswitch is not properly connected when the system is turned on, a pop-up screen with an animated illustration displays on the touchscreen and the system cannot be placed into READY mode.

Inserting the Remote Interlock Plug

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

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

Footswitch receptacle

Interlock receptacle

WARNING

6


Connecting the Main Power Cable

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

2. Insert the mains power cord plug into the appropriate wall socket, and turn on the main electrical service.

3. Set the system main power circuit breaker to the on (up) position.

Main power circuit breaker

7


System Basics

Turning On the System

Insert the key in the keyswitch, turn to the (start) position, HOLD FOR FIVE SECONDS, and release. Upon release, the key automatically springs back to the l (on) position.

Keyswitch

The touchscreen displays the start-up screen, and the system begins a self-test routine. After approximately 30 seconds, the system emits an audible tone, and the touchscreen displays the Select screen. If any fault conditions, advisory messages or error codes appear in the pop-up display during self-test, refer to the Troubleshooting section of this manual.

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.

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.

NOTE

8


Emergency Off

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

Emergency off button

Disconnecting the System


2. Set the system main power circuit breaker to the off (down) position.

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

4. Place the footswitch on the upper power cable wrap. Coil the footswitch cable and store it inside the footswitch holder. Do not wrap the footswitch cable around the power cable wrap.

5. Store the handpiece in the compartment at the front of the console.

When storing the handpiece, do not coil the umbilical too tightly, as damage to the internal optical fiber will occur.

CAUTION

9


Moving the System

1. Disconnect the system and store the handpiece as described above.

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

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

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.

3. Unlock the console wheels by disengaging the wheel locks.

4. Move the system console to the desired site. Position the console no less than 20 centimeters (8 inches) from walls, furniture or other equipment. Adequate space around the system console ensures proper air circulation.

Do not push the console over a threshold or other obstacle greater than 10 mm in height. Doing so may cause the console to tilt, resulting in user injury.

Never use the handpiece or umbilical cable to move the system. Moving the system using the handpiece or umbilical may irreparably damage the handpiece and/or umbilical.

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

CAUTION

WARNING

WARNING

CAUTION

10


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 energy is available.

Touch the button for the desired wavelength to go to the corresponding Treatment screen.

Touch to select 755 nm wavelength and go to

corresponding Treatment screen

Touch to select 1064 nm wavelength and go to corresponding Treatment screen

Select Screen

11


Treatment Screen

The Treatment screen is accessed by touching the button for the desired wavelength on the Select screen. The Treatment screen allows you to:

• select the fluence, pulse width (1064 nm only), repetition rate and spot size (refer to the User-selectable Treatment Parameters topic)

• adjust the temperature of the sapphire cooling window (refer to the User-selectable Treatment Parameters topic)

• store and recall frequently used treatment parameters (refer to the Memory Storage topic)

• view and reset the pulse counter (refer to the Displays and Indicators topic)

• select the system status (refer to the System Status: STANDBY and READY Modes topic)

• go to the Select screen (refer to the Select Screen topic)

• go to the Information & Adjustment screen (refer to the Information & Adjustment Screen topic)

Go to Select Screen

Fluence display and controls

Memory buttons

STANDBY button

Pulse counter and reset button

Go to Information & Adjustment screen

Pulse width display

Repetition rate display and controls

Spot size display and controls

READY button

Temperature display and controls

755 nm Treatment Screen (STANDBY mode shown)

Go to Select Screen

Fluence display and controls

Memory buttons

STANDBY button

Pulse counter and reset button

Go to Information & Adjustment screen

Pulse width display and controls

Repetition rate display and controls

Spot size display and controls

READY button

Temperature display and controls

12


1064 nm Treatment Screen (STANDBY mode shown)

13


Information & Adjustment Screen

The Information & Adjustment screen is accessed by touching the tab in the upper right corner of the Treatment screen while the system is in STANDBY mode. From the Information & Adjustment screen you can:

• view the total number of pulses ever recorded while using the laser handpiece

• adjust the volume of the emission indicator and other audible tones (refer to the Audible Tones topic)

• adjust the touchscreen backlighting

• adjust the aiming beam (refer to the Aiming Beam topic)

• view the software version for the system controller, display and handpiece

• go back to the Treatment screen (refer to the Treatment Screen topic)

Go to Treatment screen

Volume controls Software versions

Backlighting controls

Total number of pulses recorded

Aiming beam button

Information & Adjustment Screen

14


System Status: STANDBY and READY Modes

The system automatically goes into STANDBY mode at system start-up. In STANDBY mode:

• the footswitch is disabled

• the internal safety shutter is closed

• the treatment and aiming beams are not available

• the fluence (J/cm2), pulse width (msec) and repetition rate (Hz) fields are outlined in yellow

• the STANDBY button illuminates

755 nm Treatment Screen in STANDBY Mode

Touch the READY button to toggle to READY mode. In READY mode:

• the footswitch is enabled

• the safety shutter is open

• the treatment and aiming beams are available

• the fluence (J/cm2), pulse width (msec) and repetition rate (Hz) fields are outlined in green

• the READY button illuminates

When the system is in READY mode and the footswitch is pressed, treatment energy is discharged from the handpiece, the system emits an audible tone, and a yellow indicator next to the READY button illuminates to indicate treatment beam emission.

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.

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

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

15


755 nm Treatment Screen in READY Mode

WARNING

WARNING

NOTE

16


Aiming Beam

The aiming beam is a low power, visible laser beam that is coaxial with the treatment beam and is used to target the treatment area. All aiming beam functions are controlled from the touchscreen display. To adjust the intensity of the aiming beam:

1. Touch the tab in the upper right corner of the Treatment screen to go to the Information & Adjustment screen.

2. Point the laser handpiece at the targeted treatment site.

3. Touch the aiming beam button to toggle through the modes and intensities. There are four intensities in continuous and blink modes, as well as an OFF mode.

4. Touch the (back) button to return to the Treatment screen.

Four intensities in continuous mode

Four intensities in blink mode

Location of Aiming Beam Button on Information & Adjustment Screen

17


Memory Storage

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

Touch and hold memory button 1 or 2 for more than three seconds to save the fluence, pulse width and repetition rate settings currently displayed on the Treatment screen. Touch and hold memory button 1 or 2 for less than three seconds to recall the previously stored treatment settings.

When storing or recalling treatment settings, you must touch and hold the memory button until an audible tone is heard. Two beeps will sound when storing treatment settings and one beep will sound when recalling settings. Any existing treatment settings stored in memory will be overwritten with new settings.

Location of Memory Buttons on 755 nm Treatment Screen

NOTE

18


Displays and Indicators

The system also includes various indicators and controls to ensure safe and accurate operation.

• Pulse counter display and reset button

The console records and displays the total number of treatment pulses delivered since the last button reset.

• Emission indicator

The emission indicator illuminates during treatment beam emission (i.e., when the system is in READY mode and the footswitch is pressed).

Emission indicator

Pulse counter display

Pulse counter reset button

Location of Displays and Indicators on 755 nm Treatment Screen

19


Audible Tones

The system console emits an audible tone with every control screen selection, during treatment exposure and when an error condition has occurred.

If the laser output is greater than 120% of the requested energy, the regular exposure tone is replaced by a higher-pitched tone. If the laser output is less than 80% of the requested energy, the regular exposure tone is replaced by a lower-pitched tone.

The volume of audible tones can be increased from the minimum setting up to a setting at which the tones can be clearly heard over the system sound level. To adjust the volume of audible tones, touch the

tab in the upper right corner of the Treatment screen to go to the Information & Adjustment screen.

The volume of audible tones cannot be muted.

Location of Volume Controls on Information & Adjustment Screen

NOTE

NOTE

20


Pop-up Screens

When the system detects an abnormality during self-test or while the system is in READY mode, a pop-up screen with the corresponding error code(s) displays on the touchscreen.

Sample Pop-up Screen with Error Codes

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

“Connect Footswitch” Pop-up Screen

If the error is successfully cleared, the pop-up screen can be cleared by touching the (back) button in the upper left corner of the screen. If the error cannot be cleared, or if the error persists or reappears, note the error code(s) and contact Cutera Service (refer to Appendix C).

21


User-selectable Treatment ParametersIn pulsed lasers, such as excel HR, fluence and pulse duration affect the nature of laser-tissue interaction. The excel HR system has sufficient laser peak power to allow for a wide range of fluence and pulse duration combinations, enabling you to select optimal tissue interaction parameters. Even very small target tissues may be targeted with sufficient fluence, at appropriately small pulse durations, to achieve selective photothermolysis effects.

Treatment parameters are interrelated. Therefore, not all parameter combinations are simultaneously available. If you attempt to select a treatment setting that is not available, the system emits a distinct audible tone. Changing one or more of the other parameters may enable you to select the desired treatment setting.

Selecting the Laser Wavelength

The excel HR features two wavelengths: 755 nm and 1064 nm. Touch the button for the desired wavelength to go to the corresponding Treatment screen.

Location of Wavelength Buttons on Select Screen

NOTE

22


Selecting the Fluence

Fluence is defined as energy per unit area and is measured in joules per square centimeter (J/cm2).

Select the desired fluence by pressing the and buttons in the (fluence) field.

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

Location of Fluence Controls and Display on 755 nm Treatment Screen

CAUTION

23


Selecting the Pulse Width (1064 nm only)

Pulse width, or duration, refers to the amount of time during which therapeutically effective treatment energy is delivered; it is measured in milliseconds (ms). Select the desired pulse width by pressing the

and buttons in the (pulse width) field.

The pulse width is fixed at 3 ms for the 755 nm Alexandrite wavelength.

Location of Pulse Width Controls and Display on 1064 nm Treatment Screen

NOTE

24


Selecting the Repetition Rate

Repetition rate refers to the number of treatment pulses delivered per second and is measured in hertz (Hz). The repetition rate determines the speed at which you work. Select the desired repetition rate by

pressing the and buttons in the (repetition rate) field.

Location of Repetition Rate Controls and Display on 755 nm Treatment Screen

Selecting the Spot Size

Spot size refers to the size of the treatment spot emitted from the laser handpiece. Select the desired

spot size by pressing the and buttons in the (spot size) field.

Location of Spot Size Controls and Display on 755 nm Treatment Screen

25


Selecting the Temperature of the Sapphire Cooling Window

The excel HR handpiece features an integrated sapphire cooling window, which allows you to adjust epidermal cooling to increase safety and efficacy. Select the desired temperature of the cooling window

by pressing the and buttons in the (temperature) field.

Location of Temperature Controls and Display on 755 nm Treatment Screen

26


Cleaning the Handpiece During TreatmentIt is necessary to inspect and clean the handpiece during treatment to prevent damage to the sapphire cooling window and handpiece electrical components. The following instructions supplement the detailed handpiece and handpiece holster cleaning instructions provided in the Maintenance chapter of this operator manual.

The system must be turned off or in STANDBY mode prior to inspecting the cooling window. Do not inspect the window while the system is in READY mode. Always wear proper eyewear while the system is on. Severe eye damage can occur in the event of unintended laser emission.

Sapphire cooling window

Patient contact surface

Cooling foot

Treatments without gel

During treatment, inspect the cooling window for debris and ejected excel. Wipe the patient contact surface of the handpiece every 5 pulses with a cloth dampened with isopropyl alcohol, or with a germicidal disposable wipe.

Treatments with gel

Excessive gel on the handpiece can leach into crevices and compromise the integrity of the handpiece; therefore, observe the following precautions when using gel with treatment:

• use only a thin layer of gel on the skin

• do not handle the handpiece with gel-covered gloves

• wipe the patient contact surface of the handpiece (both the cooling window and cooling foot) with a 4x4 gauze every 50 pulses to remove excess gel, ejected excel, or debris

• wipe the gel from back to front of the bottom of the handpiece to prevent gel from getting into handpiece crevices

• clean the handpiece of any gel prior to placing handpiece into the handpiece holster on the excel HR system.

WARNING

Wipe the gel from back to front Do not handle the handpiece with gel-covered gloves

27


28


29


Maintenance

Troubleshooting GuideIf your system fails to operate properly, this troubleshooting guide will help you to locate and correct any problems. First, please check for the following items:

1. Electrical power source...verify that the electrical disconnect switch (i.e., circuit breaker) is in the on (up) position.

2. System console electrical...verify that the system is on and properly connected to an electrical service outlet.

3. Remote Interlock...verify that the remote interlock plug is inserted into the interlock receptacle. If the remote interlock plug is used in conjunction with an external door switch, verify that the treatment room door is closed.

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.

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Probable Cause: The electrical outlet is defective. Suggestion: Use another outlet or have the outlet professionally tested and, if

appropriate, repaired.

Probable Cause: The remote interlock plug is not connected to the system console. Suggestion: Insert the remote interlock plug into the interlock receptacle, and then

turn the keyswitch to the start position.

The treatment beam is not present, although aiming beam operates properly.Probable Cause: There is an internal system failure. Suggestion: Contact Cutera Service (refer to Appendix C).

The treatment beam and aiming beam are not present. Touchscreen displays and indicators are normal.Probable Cause: The system is in STANDBY mode. Suggestion: Place the system in READY mode.

Probable Cause: There is an internal system failure. Suggestion: Contact Cutera Service (refer to Appendix C).

Inadequate or no aiming beam.Probable Cause: The aiming beam is either set to “OFF” or at a low setting. Suggestion: Adjust the aiming beam intensity on the

Information & Adjustment screen. If adjusting the aiming beam does not resolve the problem, contact Cutera Service (refer to Appendix C).

Low or no energy output (patient reports no sensation).Probable Cause: The handpiece window is dirty or damaged. Suggestion: Using a test area, such as an arm, confirm that the handpiece is not

emitting a treatment beam. Check to see if the aiming beam is present. Clean or replace the handpiece window as described in the Routine User Maintenance section of this manual. If the problem is not resolved, contact Cutera Service (refer to Appendix C).

System displays E224 during a procedure.Probable Cause: The handpiece cooling tip is above the preset temperature. Suggestion: Do not use a thick layer of gel, as this increases the cooling

requirement.

Ensure that the heat exchanger on the bottom of the system is free of dust and debris. See the Routine User Maintenance section.

Ensure that the room temperature is below 27° C.

31


“Connect Footswitch” advisory pop-up screen appears on the touchscreen with its corresponding error code(s).Probable Cause: The footswitch is not properly connected to the console. Suggestion: Ensure that the footswitch is properly connected to the console. Touch

the (back) button in the upper left corner of the pop-up screen to clear the advisory message.

“Water Low” advisory pop-up screen appears on the touchscreen.Probable Cause: The system is low on water. Suggestion: Turn off the system, and add water as instructed in the Routine User

Maintenance section. Restart the system to continue with treatments.

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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 tripped. Suggestion: Place the system main power circuit breaker in the on (up) position.

Probable Cause: The remote interlock is in use, and the treatment room door has been opened.

Suggestion: Close the treatment room door, and restart the system.

33


Error Code GuideThe excel HR uses state-of-the-art, self-diagnostic software. When the system detects an abnormality during self-test or while the system is in READY mode, a pop-up screen displays with the corresponding error code(s). Some errors serve as a warning and are clearable by touching the button in the pop-up screen. Others, such as “connect footswitch” and “water low”, are accompanied by an animated illustration showing what action to take. If the error or abnormal condition is successfully cleared, the pop-up screen can be cleared by touching the button.

Below is a brief explanation of some of the codes that may be seen in the advisory pop-up screen. If you have any questions about this information or the operation and service of your system, contact Cutera Service (refer to Appendix C).

Error Code Series/Description

Series 100 Codes - Series 100 Codes appear as a warning and typically will not hinder treatment(s). Most Series 100 Codes are clearable by resuming treatment or by touching the button. If after touching the button the code does not clear, power off and re-start the system.

Series 200 Codes - Series 200 codes are “user clearable” faults and must be cleared in order to resume treatment(s). To clear, touch the button. If after touching the button the code does not clear, power off and re-start the system.

Series 300 Codes - Series 300 codes indicate a “permanent fault” and the system must be powered off and re-started to clear the code. If this action fails to clear the code, contact Cutera Service (refer to Appendix C) to schedule an appointment.

* Contact Cutera Service (refer to Appendix C) if additional alert codes appear.

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 Cutera Service (refer to Appendix C).

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Annual System MaintenancePreventive maintenance, safety, power, and calibration checks should be performed annually by a Cutera representative to ensure proper system performance.

System RepairAll system repairs should be performed by a Cutera-certified service engineer. For training and information, contact Cutera Service (refer to Appendix C).

Routine User Maintenance

Clean the external surfaces of the system console Weekly, or as needed

Clean the system touchscreen display Weekly, or as needed

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

Fill the coolant reservoir On installation or if water evaporates

Inspect and clean the handpiece During treatment, as needed, and between patient use

Inspect and clean the handpiece holster Daily, or as needed

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.

Do not attempt to gain access to any internal components. Electrical shock and/or unintended laser exposure may result. Do not spray or pour cleaning agents directly on the system console.

Cleaning the System Touchscreen Display

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

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

WARNING

CAUTION

35


Inspecting and Cleaning the Heat Exchanger IntakeThe heat exchanger intake, located on the bottom of the system console, should be kept free of dust and lint accumulation. If the heat exchanger intake becomes clogged, the system will overheat prematurely, resulting in a temperature-related error code (i.e., E221, E224, or E229).

Inspect and clean the heat exchanger regularly using a hand mirror and long-handled bath brush as described below.

1. Using a hand mirror, inspect the bottom of the system console for dust or lint accumulation.

2. Clean the heat exchanger intake by inserting a long-handled bath brush under either side of the system console, then pulling the brush toward your body to remove any dust or lint.

3. Repeat on the opposite side of the console to ensure that the entire heat exchanger intake is clean.

36


Filling the Coolant ReservoirThe system requires clean de-ionized or distilled water. Systems are delivered without any water in them and must be filled with distilled water upon installation. Occasionally, distilled water may need to be added to “top off” the system reservoir.

Permanent damage to internal components will occur if improper coolant is used. One gallon of distilled water is shipped with every system. Under no circumstances should ethylene glycol, tap water or any liquid other than de-ionized or distilled water be used.

To completely fill the coolant reservoir in the system:

1. Turn off the system.

2. Open the reservoir door on the front of the system, and remove the reservoir fill cap.

Reservoir door

Reservoir fill cap

3. Carefully add water to the reservoir; do not overfill. Use only clean, unused distilled/de-ionized water.

4. Turn the system keyswitch to the (start) position and release to the l (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.


7. Carefully top off the reservoir.

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

CAUTION

37


9. Replace the fill cap, and close the reservoir door.

Ensure that the fill cap has a small hole to vent the system. A similar fill cap without a vent hole is used to transport the system.

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

Inspecting and Cleaning the HandpieceInspect and clean the handpiece as described in the following sections. In addition to the external surfaces of the handpiece, there are three optical surfaces that need to be maintained: the recessed lens and the patient contact and proximal surfaces of the cooling window.

Proximal surface of cooling window

Patient contact surfaceof cooling window

Recessed lens

CAUTION

NOTE

38


Inspecting and Cleaning the External Surfaces of the HandpieceInspect and clean the handpiece housing, treatment guide and umbilical cable between patient use with a germicidal disposable wipe, such as Sani-Cloth® Plus or Sani-Cloth® HB from Professional Disposables International, Inc.1

Before inspecting and cleaning the handpiece, ensure that the system is either turned off or in STANDBY mode. Always wear proper protective eyewear while the system is on. Severe eye damage can occur in the event of unintended laser emission.

Do not allow liquid or cleaning solution to enter the handpiece housing, as damage may occur.

Do not attempt to sterilize the handpiece. Damage will occur if the handpiece is autoclaved, immersed or otherwise handled improperly.

Inspecting and Cleaning the Handpiece Lens

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

The system must be turned OFF or in STANDBY mode prior to inspecting the lens. Do not inspect the lens while the system is in READY mode. Always wear proper eyewear while the system is ON. Severe eye damage can occur in the event of unintended laser emission.

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

WARNING

CAUTION

CAUTION

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

WARNING

CAUTION

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

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

39


Clean the handpiece lens using a clean wood stick cotton swab and lens cleaning grade acetone, as described below.

For optimal results, use acetone with 0.5% or lower water content, which is available at most camera shops. If unable to obtain acetone with 0.5% or lower water content, contact Cutera Service (refer to Appendix D).

Use only wood stick cotton swabs. Do not use products such as Q-Tips as they contain an adhesive that dissolves when it comes in contact with acetone.

1. Ensure that the system is turned OFF or is in STANDBY mode.

2. Place a small amount of acetone on a wood stick cotton swab; if necessary, shake the excess acetone off of the tip prior to cleaning the handpiece lens.

3. Gently wipe the surface of the lens.

Recessed lens

CAUTION

NOTE

NOTE

NOTE

40


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

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

Inspecting and Cleaning the Cooling WindowThe cooling window has two optical surfaces that need to be maintained: the patient contact surface and the proximal surface. Prior to treatment, as well as periodically during treatment, inspect both surfaces of the cooling window for cracks and debris. If the cooling window is cracked or otherwise damaged, do not use the handpiece. If the cooling window is dirty, clean as directed below.

The system must be turned off or in STANDBY mode prior to inspecting the cooling window. Do not inspect the window while the system is in READY mode. Always wear proper eyewear while the system is on. Severe eye damage can occur in the event of unintended laser emission.

Inspecting and cleaning the cooling window is the responsibility of the practitioner. If the cooling window is not properly maintained, debris can build up on the surface of the window, leading to permanent damage to the window. If debris cannot be removed from the window, the handpiece must be replaced.

1. Ensure that the system is turned OFF or is in STANDBY mode.

2. Clean the patient contact surface of the cooling window, as follows: Prior to treatment, clean the patient contact surface with a germicidal disposable wipe, such as Sani-Cloth® Plus or Sani-Cloth® HB from Professional Disposables International, Inc. During treatment, clean the patient contact surface every 50 pulses, or as necessary, with 4x4 gauze if gel is used. If gel is not used, clean the patient contact surface every 5 pulses, or as necessary, with a cloth dampened with isopropyl alcohol or with a germicidal disposable wipe.

The patient contact surface has no optical coating; therefore, aggressive scrubbing and cleaning of this surface is permitted.

CAUTION

WARNING

CAUTION

NOTE

41


3. Clean the proximal surface of the cooling window, as follows: Prior to treatment, clean the proximal surface of the cooling window with a germicidal disposable wipe. During treatment, keep the proximal surface of the cooling window clear of gel by gently wiping periodically with 4x4 gauze. Excessive top side gel may affect laser beam output, possibly leading to adverse events such as burns.

The proximal surface of the cooling window has a delicate optical coating; take care to not scratch this surface. Use a new germicidal disposable wipe or 4x4 gauze, as applicable, each time the proximal surface is cleaned.

Proximal surface Patient contact

surface

4. Inspect the cooling window. If necessary, clean the window again.

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

NOTE

CAUTION

42


Inspecting and Cleaning the Handpiece HolsterClean the handpiece holster daily to prevent the accumulation of gel and debris. Before cleaning the holster, place the handpiece in the system front pocket to protect it from damage.

Do not attempt to remove the handpiece holster from the system in order to clean it.

Clean the inside of the holster with a germicidal disposable wipe. To remove debris from grooved surfaces inside the holster, wrap a tongue depressor in a germicidal wipe and clean between the grooves, as shown below. A bottle brush that has been soaked in water and mild detergent can also be used.

Avoid dripping water onto the system while cleaning the holster.CAUTION

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Remote Interlock Pin AssignmentsTo connect an external door switch to the remote interlock plug, you must purchase a replacement four pin Mini DIN Plug and an external door switch. Connect the external door switch to the pin assignment in the table below.

Pin Signal Name Signal Description

1 Return Connect to switch common

2 Remote Interlock Connect to Switch, Normally Open

3 None No Connection

4 None No Connection

3

21

4

Remote Interlock Pin Assignments (mating face shown)

44


Electrical UtilitiesThe excel HR accepts mains power from 200-240 VAC. Power must be supplied from a dedicated 220±10% VAC, single-phase, 50/60 Hz source. The wiring should be rated for 30 amps (as per local codes) “Hospital Grade” (NEMA L-20P or NEMA L-30P). Such a connection will ensure compliance with allowable leakage current levels (<500 uA) per IEC 60601-1 for this device.

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

System SpecificationsSpecifications subject to change without notice.

Treatment Beam

Type Alexandrite High Power, Long Pulse Nd:YAG

Wavelength 755 nm 1064 nm

Fluence 4-100 J/cm2 3-300 J/cm2

Pulse Width 3 ms 0.1-300 ms

Repetition Rate 2 Hz and single shot 10 Hz and single shot

Delivery System Permanently attached umbilical and handpiece

Treatment Spot 5–18 mm 3–18 mm

Epidermal Cooling Full contact thermoelectric chiller

System Cooling Self-contained, water to air heat exchanger

Aiming Beam 635 nm

WARNING

45


Physical ParametersSize (W X D X H): 13 in X 18 in X 38 in (.33 m X .46 m X .96 m)

Weight: 140 lbs (63.5 kg)

Operating length of umbilical: 6.5 ft (2 m)

Minimum bend radius of Storage 5 in (126 mm) umbilical: Momentary 2 in (50 mm)

Electrical RequirementsVoltage, Current 200 - 240 V~, 30 A Frequency 50/60 Hz

Environmental RequirementsTemperature Operating 5º C to 30º C

Non-operating -10º C to 50º C, coolant drained

Humidity 0 to 90%, non-condensing

Max. Heat Dissipation 4,000 Watts

Max. Altitude Operating 15,000 ft Non-operating 50,000 ft

Atmospheric Pressure 20 to 110 kPa

Maximum Allowable Temperature of Accessible Parts

Parts User/Patient Can Touch Material Duration Limits

Enclosure Plastic > 1 min 48º C

Touchscreen Plastic > 1 min 48º C

Handpiece Window Sapphire > 1 min 20º C

Handpiece Treatment Guide Metal > 1 min 20º C

ClassificationsFDA Classification Class II Medical Device CDRH Classification Class IV Laser Product European MDD 93/42/EEC Laser Classification Class 4 Laser to IEC 60825-1:2014

Type BF

Applied Part Handpiece

46


Eyewear Specifications

Never look directly into the handpiece, even if appropriate safety eyewear is being worn.

For general information on the ocular hazards associated with the excel HR, refer to the Safety and Regulatory chapter of this manual.

755 nmNominal Ocular Hazard Distance (NOHD) 200 m

Maximum Permissible Exposure (MPE) 2.81*10-4 W/cm2

Minimum Optical Density (OD) for Protective Eyewear 7

1064 nmNominal Ocular Hazard Distance (NOHD) 82 m

Maximum Permissible Exposure (MPE) 2.69*10-4 W/cm2

Minimum Optical Density (OD) for Protective Eyewear 6.2

WARNING

NOTE

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

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

DISCLAIMER WARNING

Calibration is a service procedure to be performed only by a Cutera-certified Service Engineer or customers who have taken and passed a Cutera Service Certification Training course. Adjustments by anyone other than a trained Cutera Service Engineer or a certified customer voids any existing manufacturer’s warranty on the instrument. A service manual for your system may be purchased from the Cutera Service Department. However, possession of service instructions or service tooling does not authorize repair or modification of a Cutera system by uncertified personnel.

Calibration must be performed by an engineer or technician certified to work on energized electronic laser equipment. Questions regarding this procedure should be referred to Cutera Service (refer to Appendix C).

Equipment Required• Laser safety eyewear for all persons in the room (with appropriate optical densities at the

wavelengths being generated).

• Laser energy meter (Ophir Nova display unit model with L40-150A-SH sensor). The meter used must have received a NIST-traceable calibration within the past 12 months (in the US) or a calibration conforming to the applicable standard (internationally).

Calibration Instructions

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

2. Ensure that all personnel in the room are wearing the appropriate eyewear.

3. Connect the service computer to the serial port.

4. Start the system in service mode and using the Cutera Service software, place the system in CALIBRATION mode.

5. Follow the prompts on the calibration screen.

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6. Place the system in User mode and verify the calibration using an external meter.

Any work performed by unauthorized personnel will void all warranties.

Warranty InformationFor specific and detailed warranty information for your system, please 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 system must be disposed of according to local laws and hospital practices. This product is considered electronic equipment and must not be disposed of as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment.

Proper disposal of electronic equipment is required according to EU Directive 2002/96/EC Waste Electrical and Electronic Equipment (WEEE).

CAUTION

49


Safety and Regulatory

IntroductionCutera lasers and handpieces, 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.

Users must take precautions to prevent exposure of laser energy to the eyes and skin from either direct or diffusely reflected light, except as a therapeutic application. Additional precautions must be taken to prevent fire, electrical injury and explosion.

Cutera does not make recommendations regarding the practice of medicine. Treatment parameters are provided as a guide. Individual treatments should be based on clinical training, clinical observation of laser-tissue interaction and appropriate clinical endpoints.

Optical HazardSafety eyewear is routinely required with most lasers. Personnel responsible for laser safety should determine the need for safety eyewear based on the Maximum Permissible Exposure (MPE), Nominal Hazard Zone (NHZ), the Nominal Ocular Hazard Distance (NOHD) and the optical density (OD) for the 755 nm and 1064 nm wavelengths and the configuration of the treatment room (usually within the controlled area). For additional information, refer to ANSI Z136.3-2005, ANSI Z136.1-2007, or European Standard EN 60825-1:2014, Annex A.

Cutera laser systems are Class IV Laser Products as defined by the U.S. Code of Federal Regulations and Class 4 Lasers as defined by the European Communities Medical Device Directive.

The laser light produced by the excel HR is invisible infrared (755 nm and 1064 nm) light that can cause permanent eye damage. Never look directly into the handpiece even when wearing protective eyewear. Never look directly into the treatment beam or at scattered light from metallic or other reflective surfaces. Both direct and reflected laser light may contain sufficient energy to cause permanent eye damage.

50


All personnel operating or in the vicinity of the excel HR, including the patient, staff personnel and observers, should wear protective eyewear with sufficient protection (i.e., optical density specified in the Eyewear Specifications section, or greater) for the 755 nm and 1064 nm wavelengths. The eyewear should have guards on both sides to protect the eyes from lateral exposure.

Never allow anyone without proper protective eyewear near the system while in use.

Guidelines and information on the safe use of lasers, and the safe use of lasers/laser systems in diagnostic and therapeutic areas, can be found in the following:

• The American National Standard for the Safe Use of lasers in Health Care Facilities (ANSI Z136.3-2005).

• The American National Standard for Safe Use of Lasers (ANSI Z136.1-2007).

• European Standard EN 60825-1:2014, Annex A.

The ANSI and the European standards describe the following terms in the description of laser hazards:

• Maximum Permissible Exposure (MPE) - The highest level of laser radiation to which a person may be exposed without hazardous effect or adverse biological changes in the eye or skin.

• Nominal Ocular Hazard Distance (NOHD) - The distance along the axis of the unobstructed beam beyond which exposure during normal operation is not expected to exceed the appropriate MPE. This distance is measured from the laser aperture.

• Nominal Hazard Zone (NHZ) - The space within which the exposure level during normal operation exceeds the applicable MPE. The outer limit of the NHZ is the NOHD.

For specific values, see the Eyewear Specifications section of this manual.

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

1. To alert personnel before they enter the controlled area, place a warning sign on the outside of the treatment room door when the laser is in use.

WARNING

WARNING

51


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

3. External door interlocks that automatically disable the system when the treatment room door is opened may be installed.

A blocking barrier, screen or curtain capable of blocking or filtering the treatment beam may be placed to create a controlled area inside a large treatment room. The barrier should be made of material that can withstand the power of the treatment beam for the maximum exposure time, relative to the configuration of the controlled area and the treatment parameters for the specific medical application.

Depending on the procedure, the physician must protect the patient’s eyes with either laser safety eyewear or with diffuse metal eye shields. Apply wet gauze over the eye lid when using metal eye shields.

Additional Ocular Protection

Never substitute non-laser prescription eyewear for the appropriate laser safety eyewear, as severe damage could occur.

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

Never look directly into any optical lens, optical fiber, handpiece or system aperture while the system is energized. Severe eye damage could occur. Turn off the system before inspecting any handpiece or system component.

NOTE

WARNING

WARNING

WARNING

52


Additional Safety Considerations

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.

No modification of the excel HR system is allowed.

The excel HR is intended solely for licensed practitioners trained in its proper use.

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

Protecting Non-Target Tissues

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.

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

Electrical Hazard

To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

High voltages are present inside the system. Do not remove the exterior housing.

WARNING

WARNING

CAUTION

CAUTION

WARNING

WARNING

WARNING

WARNING

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.

53


Fire Hazard

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.

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.

WARNING

WARNING

WARNING

WARNING

WARNING

WARNING

54


Operational Training

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

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.

Do not attempt to use this system until you have been properly trained on system operation by certified personnel and have read this manual thoroughly.

Refer to the Treatment Guidelines accompanying this operator manual and to the Cutera website for available training options and resources. The Treatment Guidelines can also be obtained from your local Cutera representative or on the Cutera website.

In addition to laser safety training of personnel, the user should consider adopting a training and safety program as outlined by the latest ANSI Standard Z-136.3, the American National Standard for the Safe Use of Lasers in Health Care Facilities or an equivalent European Union standard. The practitioner should also keep current with all relevant medical literature.

WARNING

CAUTION

CAUTION

55


Operational Safety

WARNINGLaser plume may contain viable tissue particulates. The plume presents a possible pollution hazard and should be effectively evacuated. A commercial smoke evacuator designed for use with aesthetic lasers may be used.

WARNINGDo not place any unnecessary stress on the umbilical cable (e.g., by pulling on it, tightly bending it or twisting the handpiece). Doing so may damage the cable and/or expose the patient or user to hazardous laser radiation. See the System Specifications section for additional information on the minimum bend radius for the umbilical cable.

WARNINGThe handpiece is a fragile instrument and must not be dropped. If it is dropped, you must carefully examine the handpiece for any physical damage prior to use.

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

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

WARNINGDo not leave the system in READY mode when not in use. Always place the system in STANDBY mode or turn off the system and remove the key when not performing treatments.

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.

56


CAUTIONAlways verify that the treatment parameters are correct before activating the system.

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

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

NOTEThe recessed lens(es) and the cooling window on the handpiece should be kept clean during and prior to each treatment procedure. See the Maintenance section for recommended cleaning and disinfecting procedures.

57


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 60601-1-6, IEC 62366, IEC 60601-2-22 and IEC 60825-1

• European Communities Medical Device Directive 93/42/EEC

Location of Controls

Operation and adjustment controls are located so that the user need not be exposed to the treatment beam 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 l (on) or (start) position, and the system will only operate with the key in place. When the system is not in use, always remove and store the key.

Emergency Off Button

The system can be immediately shut down, terminating laser emission, by pushing the red emergency off button that is located next to the keyswitch. Following emergency shutoff, the keyswitch must be used to restart the system.

Laser Emission Indicator

The treatment beam can only be delivered when the system is in READY mode and the READY icon is highlighted on the touchscreen display. When the footswitch is pressed and the treatment beam is being delivered, the system emits an audible tone, and a yellow indicator next to the READY button illuminates to indicate treatment beam emission.

Remote Interlock

A remote interlock connector on the back panel, when used in conjunction with an external switch connected to the treatment room door, will shut the system down if the treatment room door is opened.

58


Protective Housing

The system console has protective housings that prevent unintended human access to laser radiation above Class I limits. The housing must be opened only by a Cutera-certified representative.

No section of the protective system housing can be opened without special tools.

Laser Safety Shutter

The system console contains a “normally closed” safety shutter that prevents treatment beam emission when in the closed position. The shutter is opened only when the system is in the READY mode.

Audible Emission Indicator

Each treatment beam exposure is accompanied by an audible tone. In addition, a distinctive “water drop” sound is emitted each time the pulse counter reaches a count that ends in “00” in order to indicate the delivery of 100 shot increments.

Manual Reset

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

Electronic Fault Detection Circuitry

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

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

NOTE

59


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.

(01)00816722021502(11)YYMMDD(21)EHyyyyy

Unique Device Identifier (UDI) Label

2D barcodeGlobal Trade Identification Number (GTIN)Date of ManufactureSerial Number

(01)00816722021502(11)YYMMDD(21)EHyyyyy

Location of Regulatory Compliance Labels on System Console and Handpiece (Refer to the following pages for label illustrations and Appendix B for symbol descriptions.)

60


Regulatory Compliance Labels

3240 Bayshore Blvd.Brisbane CA 94005, USA

REF

SN

EXCELHR EH12345 YYYY-MM-DD Brisbane, CA 200-240 V~, 30 A, 50/60 Hz

Complies with 21 CFR 1040.10 and 1040.11except for deviations pursuant to Laser

Notice No. 50, dated June 24, 2007

INVISIBLE AND VISIBLE LASER RADIATIONAVOID EYE OR SKIN EXPOSURE TODIRECT OR SCATTERED RADIATIONOutput: 60 J Max at 755 nm 100 J Max at 1064 nmDuration: 3 ms at 755 nm 0.1-300 ms at 1064 nm

Class 4 Laser ProductPer IEC 60825-1:2014

Aim Beam: ≤ 1 mW Max at 635 nm, Class 2

5°C

30°C

0044

Rx only

excel HR Identification Label

Certification label

Emergency Stop Button

Located on top of console (next to red button)

Non-interlock Housing Label

Located at lower corner on each side of console

System OFF

Located next to keyswitch

System ON


Momentary Start


Tilting Hazard Label

Located on sides of system console(Warning of tilting hazard. Do not pushconsole over obstacle >10 mm in height.

Doing so may cause user injury.)

OR

Laser Radiation Warning

Located on handpiece(Warning of laser radiation from adjacent aperture)

61


62


Electromagnetic CompatibilityThe excel HR laser system design complies with IEC 60601-1-2 (3rd edition) requirements for electro-magnetic compatibility (EMC) with other devices. Like other electrical medical equipment, the excel HR requires special precautions to ensure EMC with other electrical medical devices and must be installed and operated according to the EMC information provided in this manual.

Portable and mobile RF communications equipment may affect the normal function of the excel HR.

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

If the excel HR laser system is used adjacent to or stacked with other equipment, observe and verify normal operation of the excel HR in the configuration in which it will be used prior to using it in a surgical procedure. Consult the tables below for guidance in placing the excel HR.

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

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

Emissions test Compliance Electromagnetic Environment: Guidance

RF emissions CISPR 11 Group 1 excel HR laser systems use 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 excel HR laser systems are 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

CAUTION

WARNING

WARNING

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 excel HR requires continued operation during power mains interruptions, it is recommended that the system console 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.

63


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 system console, 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 d = 1.17 √P 80MHz to 800MHz d = 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 excel HR laser system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system console.

(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

64


Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the System Console

The excel HR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the excel HR can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system console 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.

65


66


67


Clinical Applications

General Indications for UseThe excel HR is intended for use in aesthetic and cosmetic procedures in the medical specialties of dermatology and plastic surgery.

755 nm Alexandrite Indications

The 755 nm output wavelength is indicated for:

• treatment of unwanted hair

• long term or permanent hair reduction

• treatment of benign pigmented lesions including, but not limited to, lentigos, solar lentigos, seborrheic keratoses, and nevi

• treatment of wrinkles including, but not limited to, periocular and perioral wrinkles

• treatment of benign vascular lesions including, but not limited to, port wine stains, hemangiomas, and telangiectasia

1064 nm Nd:YAG Indications

The 1064 nm output wavelength is indicated for:

• treatment of unwanted hair

• long term or permanent hair reduction

• treatment of pseudofolliculitis barbae (PFB)

• treatment of benign vascular lesions including, but not limited to, telangiectasia, rosacea, leg veins, spider veins, angiomas, hemangiomas, port wine stains, and venous lake

68


• treatment of benign cutaneous lesions including, but not limited to, warts, scars, and striae

• treatment of mild to moderate inflammatory acne vulgaris

• treatment of wrinkles including, but not limited to, periocular and perioral wrinkles

Contraindications for UseContraindications for use:

• Pregnant patients

• Patients undergoing treatment for skin cancer

Warnings• Do not treat over dysplastic nevi or questionable pigmented lesions.

• Do not treat over or close to tattoos or permanent make-up.

• Hair removal by lasers can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern and South Asian heritage treated on the face and neck.

Precautions• Photosensitizing drugs (Tetracyclines, etc.)

• 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) use within the previous 6 months

• History of vitiligo

69


Expected Transient Events and Possible Adverse Effects• Erythema, edema, and purpura may occur following treatment and typically resolve with

time.

• Hyperpigmentation, hypopigmentation, burns, erosion, epidermal crusting, or blistering may occur, some of which may result in scarring.

• Temporary or permanent gray hair (leukotrichia) may develop.

• Stimulation of terminal hair growth may occur within or adjacent to treated area.

• Undesired hair loss in hair-bearing areas may result from treatment of vascular and benign pigmented lesions.

• Sun exposure, tanning beds, and artificial tanning may increase the risk of side effects and adverse events.

• Itching, bumps, and rash may occur following treatment.

• Deep tissue injury and prolonged wound healing may occur when treating warts.

• Hemosiderin staining

• Textural changes/cutaneous indentations

Treatment PrecautionsThe excel HR should only be operated by qualified personnel who have received appropriate training. In addition to the information provided in the Safety and Regulatory section of this manual, the following safety precautions are recommended:

• Guard against accidental exposure to laser energy.

• Instruct all staff members to carefully aim the treatment beam only at the targeted treatment areas.

• Ensure that the patient and all staff personnel in the treatment room wear appropriate protective eyewear. If the patient cannot wear protective eyewear, fit the patient with opaque eye protection that will completely block light to the eyes. The eyewear must provide adequate protection from laser radiation of the wavelength being used. See the Eye Safety section in the Maintenance chapter for protective eyewear requirements.

• Instruct all staff members and patients to never look directly at the laser light or reflective surfaces, even when wearing proper protective eyewear.

Never allow anyone near the system while the system is in use without proper protective eyewear. Unprotected laser exposure can cause permanent eye damage.

WARNING

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

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

It is recommended that the clinical user begin with a low fluence and observe the tissue response before increasing the fluence. Increasing the fluence may provide increased efficacy, however factors such as skin type and tanning may limit the maximum usable fluence without unwanted epidermal damage.

70


TreatmentsThe excel HR can be used to remove unwanted hair; to treat benign vascular, cutaneous, and pigmented lesions; to treat wrinkles; and to treat mild to moderate inflammatory acne. Perform and observe test spots prior to treatment. Potential adverse reactions may take 24-72 hours to appear. Pigmentation changes for darker skin type patients may develop up to several weeks following treatment.

• Test spot fluence settings are determined by evaluating skin type and, for hair removal procedures, hair color, thickness and density.

• Treatment settings should be selected based on test spot clinical response.

• Perform test spots on the same area as being treated.

• Deliver single pulses to assess clinical response and potential adverse reactions.

• Deliver 3 to 4 adjacent pulses to assess skin's reaction to bulk heating.

When used for hair removal, 755 nm and 1064 nm laser energy is selectively absorbed by melanin in the hair follicle and shaft, resulting in selective destruction of the hair structure without damaging the epidermis or surrounding tissue. Because the laser energy is absorbed by melanin in the epidermis, as well as by the desired target structures, the epidermal-cooling feature integrated in the handpiece is used to reduce the temperature rise in the epidermis.

WARNING

WARNING

CAUTION

71


When treating benign pigmented lesions, the excel HR specifically targets the superficial pigment in the epidermis. In choosing the wavelength spectrum with strong melanin absorption and low hemoglobin absorption, lower fluences are needed for effective treatment.

When treating vascular lesions, the blood temperature at the targeted area is elevated to a level that causes coagulation without damage to the epidermis or surrounding tissue. Since 755 nm and 1064 nm laser energy is absorbed by melanin in the epidermis, as well as the desired target of hemoglobin, the epidermal-cooling feature integrated in the handpiece is used to reduce the temperature rise in the epidermis. Multiple treatments may be necessary to obtain a satisfactory response.

The excel HR gives the user the flexibility to adjust key parameters. Pulse width and fluence parameters can be adjusted based on target size, skin type and tan, if present.

For recommended treatment settings, please refer to the Treatment Guidelines accompanying this operator manual.

Patient InformationPrior to treatment, the user should conduct a patient consultation. The consultation should include a complete medical history and exam. At that time, the user should also discuss all potential benefits, complications, options and risks of treatment.

72


A-1


Appendix A - Laser Warning Sign

excel HR Laser Warning Sign

A-2


B-1


Appendix B - SymbolsThis appendix describes the laser system symbols and their meanings.

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

Cutera-defined Fluence (J/cm2) Touchscreen display

Cutera-defined Pulse width (ms) Touchscreen display

Cutera-defined Repetition rate (Hz) Touchscreen display

B-2


Cutera-defined Laser emission indicator Touchscreen display

Cutera-defined Aiming beam adjustment Touchscreen display

Cutera-defined Temperature of sapphire cooling window

Touchscreen display

Cutera-defined Save/recall settings in memory store

Touchscreen display

Cutera-defined Pulse counter reset Touchscreen display

Cutera-defined Spot size Touchscreen display

Cutera-defined Go to Information & Adjustment screen

Touchscreen display

Cutera-defined Return to previous screen Touchscreen display

Cutera-defined Volume of audible tones and indicators

Touchscreen display

Cutera-defined Touchscreen backlighting Touchscreen display

Cutera-defined System controller software version

Touchscreen display

Cutera-defined Handpiece software version Touchscreen display

Cutera-defined System display software version Touchscreen display


B-3


Cutera-defined Footswitch receptacle Rear panel label

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

Rear panel label

REF BS EN ISO 15223-1

Model number Rear panel label

SN BS EN ISO 15223-1

Serial number Rear panel label

BS EN ISO 15223-1

Date of manufacture Rear panel label

BS EN ISO 15223-1

Manufacturer Rear panel label

BS EN ISO 15223-1

Authorized representative in the European Community

Rear panel label

MDD 93/42/EEC CE Mark Rear panel label

TUVus Mark Rear panel label

IEC 60601-1 Operating temperature range Rear panel label

IEC 60601-1 Consult accompanying documents

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


B-4


IEC 60601-1 Type BF equipment Rear panel label

IEC 60825-1 Laser radiation warning Rear panel label and near laser aperture on handpiece

IEC 60825-1 Laser aperture Near laser aperture on handpiece

IEC 60601-1 Tilting hazard—do not push console over obstacle >10mm in height

Side panels

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

Rear panel label


C-1


Appendix C - Cutera Direct Office Locations

Cutera World Headquarters

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

Cutera (APAC)

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

Cutera (Europe)

Cutera France 1 rue Georges Charpak Bât C 77127 LIEUSAINT Tel: +33 (0) 1 60 62 24 40 Fax: +33 (0) 1 60 34 31 75

C-2


excel hr operator manual international customers - cutera

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