Manuel d utilisation. Operator Manual

Transcription

1 Manuel d utilisation Operator Manual

2 ii This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Cutera, Inc. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under US federal law, copying includes translations into another language. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Cutera is the registered trademark of Cutera, Inc. January 2012 Cutera, Inc. Published in USA D0677 Revision F Cutera, Inc Bayshore Boulevard Brisbane, CA USA MDSS GmbH Schiffgraben 41, D Hanover, Germany GMDN: TUV Nord UMDN:

3 iii CONTENTS INTRODUCTION 1 Warnings, Cautions & Symbols 2 Pearl Fractional Handpiece Theory of Operation 4 Console Preparation 5 Pearl Fractional Handpiece Installation 6 Inspecting the Pearl Fractional Handpiece 6 Connecting the Pearl Fractional Handpiece 6 Smoke Evacuator Installation 8 Inspecting the Smoke Evacuator 8 Installing the Smoke Evacuator 8 System Basics 11 OPERATION 13 Pearl Fractional Display Screens and Controls 13 Select Screen 13 Displays and Indicators 15 Information & Adjustment Screen 16 Control Screen 17 Pearl Fractional System Status 18 Setting the mj per Pulse 19 Setting the Repetition Rate (Delay Mode) 20 Setting the Aiming Beam 21 Selecting the Pattern Shape and Density 22 Operative Instructions 23

4 iv MAINTENANCE 25 Troubleshooting 25 Possible Problems and Solutions 26 Annual System Maintenance 27 Cleaning the Pearl Fractional Handpiece 27 Smoke Evacuator Maintenance 30 Annual Pearl Fractional Handpiece Calibration 31 Equipment Required 31 Calibration Verification Instructions 32 SAFETY AND REGULATORY 33 Introduction 33 Optical Hazard 34 Eyewear Specifications 35 Additional Ocular Protection 37 Safety 37 Protecting Non-target Tissues 38 Electrical Hazard 38 Fire Hazard 39 End of Life Disposal - Environmental Information 39 Regulatory Compliance 40 Location of Controls 40 Protective Housing 40 Electronic Fault Detection Circuitry 40 Electromagnetic Compatibility 41 Operational Training 45 Operational Safety 46 Smoke Evacuation-Laser Plume Pollution Hazard 47

5 v CLINICAL APPLICATIONS 49 Indications for Use 49 Contraindications for Use 49 Precautions 50 Expected Transient Events and Possible Adverse Effects 50 Treatment Precautions 51 Patient Information 52 Treatment Information for Skin Rejuvenation Procedures 52 SPECIFICATIONS 53 Pearl Fractional Specifications 53 Treatment Beam 53 Physical Parameters 54 Environmental Requirements 54 Classifications 54 Regulatory Compliance Labels 55 Warranty Information 56 APPENDIX A - LASER WARNING SIGN APPENDIX B - SYMBOLS APPENDIX C - BIBLIOGRAPHY APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS

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7 1 Introduction The Cutera aesthetic platforms include a variety of laser and non-laser light sources to perform various dermatologic treatments. Cutera console architecture allows owners to add user-installable handpieces as new applications and technologies develop. This operator manual introduces the new Cutera Pearl Fractional handpiece, and describes the function, use and operation in conjunction with the Xeo family of consoles. The Xeo platform is modular by design, and therefore, can accept a variety of Cutera handpieces. A similar modular design structure is applied to the associated operator manuals. Two separate operator manuals are required for any Cutera console used in combination with any user-detachable Cutera handpiece. The system operator manual is identified as the primary operator manual, which describes the use and operation of the console, while the handpiece operator manual is identified as the companion operator manual, which describes the use, operation, and general indications for a specific handpiece. The Pearl Fractional Operator Manual is the companion operator manual that describes the use and operation of the Cutera Pearl Fractional handpiece.

8 2 Warnings, Cautions & Symbols Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed. WARNING WARNING WARNING WARNING CAUTION NOTE The personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or physician. Electrical shock hazard warning. A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel. This is to alert the user to the presence of harmful laser radiation. Avoid eye or skin exposure. This biohazard symbol alerts the user of the presence of hazardous biological material, and that special handling protocols must be observed. Special service procedures or precautions must be followed to avoid damaging the instrument. Special information to make maintenance easier or important information more clear. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment.

9 3 WARNING - To avoid potential serious injury to the user and the patient and/or damage to this device, the user must: 1. Read this operator manual thoroughly and be familiar with its contents prior to using this equipment. 2. Carefully unpack the unit and check if any damage occurred during shipment. 3. Be a qualified physician or delegate, having complete knowledge of the use of this equipment. 4. Test this equipment prior to a surgical procedure. This unit was fully tested at the factory before shipment. 5. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. 6. Pay close attention to the care and cleaning instructions in this manual. A deviation may cause damage. 7. Disconnect the system from the electrical outlet when performing inspection The warranty is void if any of these warnings are disregarded. Cutera accepts full responsibility for the effect on safety, reliability, and performance of the equipment only if 1) readjustments, modifications, and/or repairs are carried out exclusively by Cutera and 2) the electrical installation of the relevant operating room complies with the applicable IEC, CEC, and NEC requirements. Cutera reserves the right to make improvements in the product(s) described herein. Product(s), therefore, may not agree in detail with the published design or specifications. All specifications are subject to change without notice. Please contact your local Cutera sales representative or agent for information on changes and new products. WARNING - US federal law restricts this device to use by, or on order of, a physician.

10 4 Pearl Fractional Handpiece Theory of Operation An Erbium:Yttrium Scandium Gallium Garnet (Er:YSGG) is a crystal medium, contained inside the Pearl Fractional handpiece to produce a laser wavelength (2790 nm), which falls in the mid-infrared region of the electromagnetic spectrum. The 2790 nm wavelength of light is strongly absorbed by water and water-bearing tissue, such as skin and eye tissue. Applying this specific wavelength of light by way of a laser pulse can easily heat and ablate tissue, making the Er:YSGG laser effective for aesthetic procedures. Cutera has incorporated the Er:YSGG laser into a computer-controlled scanning handpiece that scans a 300 µm matrix of spots in a user-selectable pattern. The user can adjust the shape of the pattern and the density of the treatment spots. A focal distance guide keeps the handpiece at the proper focal distance from the treatment area, ensuring consistent treatment results. Since the wavelength of the laser treatment beam is in the invisible mid-ir range, a 650 nm red aiming beam located inside of the handpiece, is used to display the desired scan pattern on the target tissue. The Er:YSGG laser treatment beam is optically aligned to the red aiming beam. As the footswitch is depressed, a series of laser pulses are delivered to the target tissue as indicated by the scan pattern. WARNING - As the aiming beam passes down the same delivery system as the working beam, it provides a good method of checking the integrity of the delivery system. If the aiming beam spot is not present at the distal end of the delivery system or its intensity is reduced or it looks diffused, this is a possible indication of a damaged or not properly working delivery system. When handled and operated properly, the Pearl Fractional handpiece, in combination with the Xeo console, is a useful and reliable medical instrument. After reviewing this companion operator manual, if you have any further questions regarding the Pearl Fractional, contact your local Cutera representative.

11 5 WARNINGS Any laser light emitting device can generate highly concentrated light, which may cause injury if improperly used. To protect patients and operating personnel, the entire appropriate console primary operator manual, including the Safety and Regulatory sections, should be carefully read and understood before operation. Additionally, the companion operator manual associated with a particular handpiece, such as the Cutera Pearl Fractional handpiece, should also be read and understood prior to use. Console Preparation Your Pearl Fractional compatible Cutera console should be fully operational prior to installing or using your Pearl Fractional handpiece. Please refer to the appropriate primary operator manual for details on how to prepare your console properly.

12 6 Pearl Fractional Handpiece Installation Inspecting the Pearl Fractional Handpiece Inspect the Pearl Fractional handpiece connector, umbilical cable, and handpiece housing for any damage prior to connecting the Pearl Fractional handpiece. WARNING - If the handpiece is connected to the console, verify that the system power is off. Never look directly into the emitted light or at scattered light from metallic or other reflective surfaces. Exposure can cause eye or skin damage. Inspect the pins inside the handpiece connector, and ensure that the pins are not damaged, bent, or recessed. The handpiece connector should be easily and smoothly removed without requiring significant force. Connecting the Pearl Fractional Handpiece Prior to connecting the Pearl Fractional handpiece, ensure that the handpiece resting assembly is installed in its mounting mechanism and locked into place (the locking mechanism is part of the handle assembly) and that the sensing cable is connected to the receptacle. Refer to the appropriate primary operator manual for further information. 1. Disconnect the main system electrical power. WARNING - Do not attempt to disconnect the Pearl Fractional handpiece while the system is on. 2. Ensure that the Pearl Fractional handpiece is properly resting in the holster, and route the umbilical so that it does not encumber the operator or the patient.

13 7 Xeo Console Console Xeo 3. Align the handpiece connector over the mating connector located in the top panel. 4. Press the grey buttons firmly, ensuring that the water connection mechanisms are latched in the released position. 5. Press the connector down gently to align the fittings. Once aligned, press the connector down firmly. NOTE - For proper handpiece engagement, ensure that you hear two audible clicks when installing the Pearl Fractional handpiece. 6. Reconnect the main system electrical power.

14 8 Smoke Evacuator Installation Inspecting the Smoke Evacuator Inspect the smoke evacuator unit, power cord, hoses, footswitch, and filters for any damage during shipment. If damage is found, please contact the following manufacturer for instructions: Surgimedics 2950 Mechanic Street Lake City, PA Phone: (800) (814) Fax: (800) Installing the Smoke Evacuator 1. Assemble the smoke evacuator according to the Surgimedics Operator/ Service Manual. 2. Verify that all connections (i.e. hoses, power cords) are secure. 3. Turn on the smoke evacuator, and verify that there is suction at the end of the suction hose. If there is no suction, verify that the hose is attached and secured on the smoke evacuator and that there is no obstruction in the hose. If the problem persists, refer to the Surgimedics Operator/Service Manual or call Surgimedics. 4. Turn off the smoke evacuator, and connect the vacuum adaptor assembly to the Pearl Fractional Handpiece. a. Verify that your Xeo console is turned off.

15 9 b. Attach the snorkel to the Pearl Fractional handpiece, and secure it with the thumbscrew. c. Insert the stand-off into the retaining ring, and rotate the ring 1/4 turn clockwise until you hear a click. Retaining ring Stand-off Thumbscrew Snorkel

16 10 5. Attach the open end of the smoke evacuator hose to the vacuum adaptor assembly. Smoke evacuator hose 6. Turn on the smoke evacuator, and verify that there is suction at the open end of the vacuum adaptor assembly. 7. Secure the smoke evacuator hose to the Pearl Fractional handpiece umbilical using the velcro straps provided. NOTE - Route the smoke evacuator hose so that it does not interfere with the user or the patient.

17 11 System Basics Please refer to the appropriate primary operator manual for system basic operation. Only those functions specific to the Pearl Fractional handpiece are described in this operator manual. Console functions are described in the appropriate primary operator manuals. For general console functions, or for functions associated with other Cutera handpiece models, please refer to the appropriate primary or companion operator manual.

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19 13 Operation Pearl Fractional Display Screens and Controls Select Screen Upon system turn on, a system self-test routine begins. When the routine completes, the handpiece Select screen appears, and the system will go into a STANDBY mode. In STANDBY, the footswitch is disabled and no treatment laser energy is available. The Select screen allows you to: Access the handpiece Control screen by selecting the desired handpiece icon.

20 14 Pearl Fractional Select Screen

21 15 Displays and Indicators The Pearl Fractional handpiece and compatible console use various indicators and controls to ensure safe and accurate operation. Shot Counter display including a Shot Counter Reset button. The console records and displays the total number of treatment pulses (in all modes) produced since the last button reset. Back button. The Back button returns the display from the Control screen to the Select screen or from the Information screen to the Control screen. To access the Information & Adjustment screen, select the i icon at the top right corner of the Control screen. Back button Displays and Indicators on the Pearl Fractional Control Screen Shot counter Shot counter reset button

22 16 Information & Adjustment Screen To access the Information & Adjustment screen, select the i icon at the topright corner of the Control screen. The Information & Adjustment screen allows you to: Adjust the treatment indicator volume Adjust the backlighting of the touchscreen View the version of the system software View the total number of treatment exposures delivered View the ID number of the handpiece Information & Adjustment Screen Select the Back button to return to the Control screen.

23 17 Control Screen The handpiece Control screen is accessed by selecting the graphical handpiece on the Select screen. The Control screen allows you to: Monitor the treatment indicator and the number of treatment cycles since the last reset Select STANDBY or READY mode Select treatment parameters User-selectable parameters READY button Pearl Fractional Control Screen for the Xeo STANDBY button

24 18 Pearl Fractional System Status The STANDBY and READY buttons control the laser status (mode). In STANDBY mode, the footswitch is disabled, and the aiming beam is turned off. STANDBY mode is indicated by a YELLOW color highlighting the mj per pulse area, the repetition rate area, the pattern selection area, and the STANDBY button itself. Except during actual treatment, the system may be placed in STANDBY mode at any time by pressing the yellow button in the control screen located at the lower left corner of the touchscreen. If the console is not used for three minutes, the system automatically transitions to STANDBY mode. WARNINGS 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. You must first remove the Pearl Fractional handpiece from the holster before selecting the READY button. If not, the system will remain in STANDBY mode and cannot be set to READY mode until the handpiece is removed. Selecting READY turns on the aiming beam and enables the footswitch. The aiming beam will also start displaying the selected scanning pattern outline. The READY mode is indicated by a GREEN color highlighting the mj per pulse area, the repetition rate area, the pattern selection area, and the READY button itself. Once the system is set to READY mode, an aiming beam is present, and the footswitch is enabled, you can now fire the laser using the Pearl Fractional handpiece.

25 19 Setting the mj per Pulse With the Pearl Fractional, pulse energy determines the nature of the lasertissue interaction. The mj per pulse display shows the measured energy in mj that will be delivered with each pulse to an individual spot. Press the mj per Pulse up and down buttons to select the mj per pulse. mj per pulse controls and display

26 20 Setting the Repetition Rate (Delay Mode) Press the Repetition Rate up and down buttons to select the delay between the delivery of scan sequences when the footswitch is maintained in the down position. Repetition rates of one to two seconds are typically used, with longer delays for larger patterns. The repetition rate can be reduced below one second for single pulse mode if desired. Repetition rate controls and display

27 21 Setting the Aiming Beam The aiming beam provides a visual target area to be treated. The aiming beam automatically turns on as soon as the Pearl Fractional handpiece is in READY mode. Press the Aiming Beam button to select one of three aiming beam intensities. WARNING - If the aiming beam is not present, then this is a possible indication of a damaged delivery system. Do not use the system; notify Cutera Service. Aiming beam button

28 22 Selecting the Pattern Shape and Density The Pearl Fractional handpiece produces precise patterns composed of 300 µm spots. The position of each spot is computer-controlled. The Pearl Fractional handpiece delivers a single pulse energy to each spot location. Pattern shape and density are user-adjustable. Pattern density settings correspond to the percent coverage per pass, as follows: Pattern Density Setting Percent Coverage 4% 8% 12% 16% 32% Press the Pattern Shape and Pattern Density up and down buttons to select the desired pattern shape and density. The selected pattern will appear in the Pattern display. Pattern display Pattern shape controls Pattern density controls

29 23 Operative Instructions For preoperative, intraoperative, and postoperative instructions, please refer to the Clinical Applications section in this manual, the Pearl Fractional Treatment Guidelines (D0703), and the Pearl Fractional Clinical Treatment CD (D0725).

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31 25 Maintenance Troubleshooting The troubleshooting guide in this operator manual contains troubleshooting information specific to the Pearl Fractional handpiece. This section consists of a list of common problems specific to the Pearl Fractional handpiece, and some potential solutions. Use this guide to solve problems with your Pearl Fractional handpiece. For specific information on problems associated with your Cutera console, please refer to the troubleshooting guide located in the Maintenance section of the appropriate primary operator manual for your console. Before proceeding with the troubleshooting guide, please check the following: 1. Electrical power source. Verify that the electrical disconnect switch (the circuit breaker) is turned on (in the UP position). 2. System console electrical. Verify that the system is turned on and properly connected to an electrical service outlet. D0677, REV. E 07/11

32 26 3. Handpiece connection. Verify that the handpiece(s) is properly connected and properly set in the holster. If unsure, turn off the system, then disconnect and reconnect the handpiece umbilical, listening for two audible clicks. 4. Remote Interlock. If the remote interlock plug is used in conjunction with a door switch, verify that the remote interlock plug is inserted in the remote interlock receptacle. Close the interlock door. Possible Problems and Solutions Console will not complete system self-test or display the Select screen Probable Cause: Suggestion: The handpiece is not properly connected. Unplug and reconnect the handpiece. Low or no energy output (patient reports no sensation) Probable Cause: Suggestion: The window on the handpiece is dirty or damaged. Clean the handpiece window. Console will not enter READY mode - green READY button spins Probable Cause: Suggestion: Handpiece temperature control fault. Replace the handpiece. If problem(s) still persist with the Pearl Fractional handpiece, please call your local Cutera representative. If residing in the United States, please call the Cutera Service department at D0677, REV. E 07/11

33 27 Annual System Maintenance Preventive maintenance, safety, power, and calibration checks should be performed annually by a Cutera representative to ensure proper performance. Refer to the appropriate primary operator manual for detailed information on system maintenance. Cleaning the Pearl Fractional Handpiece WARNINGS Never look into the Pearl Fractional handpiece while the system is in READY mode. Before cleaning the Pearl Fractional handpiece window, ensure that the system is either turned off or in STANDBY mode. Always wear proper protective eyewear while the system is on. Eye injury can occur in the event of unintended laser light emission. CAUTION - Do not attempt to sterilize any Cutera handpiece(s). Damage will occur if the Pearl Fractional handpiece is autoclaved, immersed, or otherwise handled improperly. Inspect and clean the Pearl Fractional handpiece window before and after each patient procedure, as described below. In addition, periodically inspect the handpiece window during each patient procedure and clean if necessary. D0677, REV. E 07/11

34 28 1. Disassemble the vacuum adaptor assembly. a. Rotate the retaining ring 1/4 turn counter-clockwise to remove the stand-off. NOTE - Replace the stand-off after each patient procedure to prevent tissue crosscontamination between patients. Although the stand-off is not a sterile item, it is a single use item. Dispose of a used stand-off using standard biohazard procedures. After each patient procedure, the retaining ring that the stand-off attaches to must be thoroughly cleaned using germicidal wipes (such as Sani Cloth and PDI) that are antiviral, antimicrobial, and antifungal. Carefully follow your office s practices regarding blood and body fluid precautions. This includes disposing of all material using standard biohazard procedures once the disinfection process is complete. b. Unscrew the thumbscrew and remove the snorkel. Retaining ring Stand-off Thumbscrew Snorkel D0677, REV. E 07/11

35 29 2. Inspect the Pearl Fractional handpiece window for any debris.inspect the Pearl Fractional handpiece window for any debris. Window 3. Clean the handpiece window with alcohol wipes. NOTE - If debris cannot be removed after repeated cleaning, or if the window is otherwise damaged, contact Cutera for handpiece replacement. D0677, REV. E 07/11

36 30 Smoke Evacuator Maintenance WARNING - Be aware that biohazardous particulates are present when performing maintenance on the smoke evacuator. These particulates are airborne, so exercise extreme caution when performing any kind of maintenance. The smoke evacuator filter should be replaced on a periodic basis. Refer to the smoke evacuator operator manual for detailed instructions on the maintenance and replacement of the filters. To inquire about the smoke evacuator or to order replacement filters or hoses, please contact the manufacturer: Surgimedics 2950 Mechanic Street Lake City, PA Phone: (800) (814) Fax: (800) D0677, REV. E 07/11

37 31 Annual Pearl Fractional Handpiece Calibration Regulatory agencies require that manufacturers of US FDA CDRH Class III and IV and European EN Class 3 and 4 medical lasers supply their customers with power calibration instructions. Customers are not able to alter the calibration of the Pearl Fractional handpiece. Instructions for verifying proper calibration are included here. Calibration of the Pearl Fractional handpiece optical output should be checked periodically. With proper care and under normal operating conditions, Cutera recommends checking the calibration every twelve 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. DISCLAIMER WARNING - Adjustment or alteration of the Pearl Fractional handpiece is a service procedure to be performed only by a Cutera-certified Service Engineer at the Cutera factory. Adjustment by anyone other than a trained Cutera Service Engineer voids any existing manufacturer s warranty on the instrument. A service manual for your appropriate console platform may be purchased from the Cutera Service department. However, possession of service instructions or service tooling does not authorize repair or modification of a Cutera system by uncertified personnel. Calibration must be performed by an engineer or technician certified to work on energized electronic laser and pulsed-light equipment. Questions regarding this procedure should be referred to your Cutera representative. Equipment Required The laser energy meter (Ophir Nova display unit model with L40-150A-SH sensor) used must have received a NIST-traceable calibration within the past twelve months (in the US) or a calibration conforming to the applicable standard (internationally). D0677, REV. E 07/11

38 32 Calibration Verification Instructions CAUTION - Any work performed by unauthorized personnel will void all warranties. 1. Set up the laser energy meter in a convenient location so that the sensor head can be easily reached with the Pearl Fractional handpiece. Set the meter display unit to the ENERGY mode. 2. Place the Pearl Fractional handpiece tip in front of the energy meter sensor head. 3. Ensure that the handpiece is connected to a Pearl Fractional compatible Cutera system, and turn on the system. 4. Verify that the laser energy meter wavelength range is set to mid-ir. 5. Place the system in READY mode, and fire a single shot into the energy meter. 6. Record the reading displayed on the energy meter and the user-selected mj per pulse reading from the system touchscreen. 7. Repeat steps 5 and 6 for the highest mj per pulse setting available. 8. Divide all of the energy meter readings by a factor of The resulting numbers should correspond to the optical mj per pulse delivered to the skin. 9. Compare the list of optical mj per pulse readings delivered to the skin and to the list of corresponding user-selected mj per pulse readings from the touchscreen display. Verify that each optical mj per pulse delivered to the skin is within 10% of the corresponding user-selected mj per pulse. D0677, REV. E 07/11

39 33 Safety and Regulatory Introduction Cutera products are safe and effective instruments for indicated clinical treatments; when used by trained personnel, such as the Pearl Fractional handpiece and compatible Cutera aesthetic platforms. Keep in mind that safe operation requires a thorough understanding of the system and safety features as described in this operator manual for the handpiece and the appropriate primary operator manual for the system. Except for therapeutic applications, precautions must be taken to prevent accidental laser light exposure to the eyes or skin; this can be direct or diffuse reflected light. Additional precautions must be taken to prevent fire, electrical injury, and explosion. Cutera does not make recommendations regarding the practice of medicine, and laser treatment information is provided as a guide. Individual treatments should be based on clinical training and clinical observation of laser light tissue interaction, and appropriate clinical endpoints.

40 34 Optical Hazard Laser safety eyewear is required for all laser systems, such as the Pearl Fractional handpiece. Personnel responsible for laser safety, such as a Laser Safety Officer, should determine the need for safety eyewear based on: Maximum Permissible Exposure (MPE) Nominal Hazard Zone (NHZ) Nominal Ocular Hazard Distance (NOHD) Optical Density (OD) of the laser light emission Configuration of the treatment room (usually within the controlled area). For additional information, refer to ANSI Z , ANSI Z , or European Standard EN :2007, Appendix A. The ANSI Z136.1 standards that laser products are designed to, determine the appropriate laser safety eyewear and eye safety characteristics. WARNING - The Pearl Fractional handpiece contains invisible infrared laser light and visible light, both of which can cause eye damage. Never look directly into the handpiece(s), even when wearing protective eyewear, or directly at laser light 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. All personnel operating or located in the vicinity of a Cutera aesthetic system, including patients, staff personnel, and observers, must wear appropriate protective eyewear, as discussed in the Eyewear Specifications topic on the next page. The eyewear should have guards on both sides to protect the eyes from lateral exposure.

41 35 WARNING - Never allow anyone without proper protective eyewear near the laser light source while the system is in use. In addition to providing the required laser safety eyewear, take the following steps to secure the treatment room or controlled treatment area. 1. Alert all personnel before entering the controlled area. 2. Place a warning sign on the outside of the treatment room door during system use. 3. Close the treatment room door during system use. 4. Install external door interlocks, if available so that the system is automatically disabled when the treatment room door is opened. NOTE - A blocking barrier, screen, or curtain capable of blocking or filtering the laser light may be placed to create a controlled area inside a large treatment room. The barrier should be made of material that can withstand the power of the treatment beam for the maximum exposure time, relative to the configuration of the controlled area and the treatment parameters for the specific medical application. Patient eyes must be protected with appropriate eyewear. Eyewear Specifications General ocular hazards information associated with the Pearl Fractional handpiece is found in the previous topic in this section. The following formula was used to calculate the worst case NOHD for the Pearl Fractional handpiece. NOHD = (1/φ) {4 Pf Φ)/(π MPE)-a 2 }

42 36 where, Z = the distance of the beam waist from the laser system (cm); a = the beam waist diameter (cm) (@1/e 2 of axial irradiance); φ = full angle beam divergence (rad) (@1/e 2 of axial irradiance); Φ= energy or power of one exposure to the beam within the aversion response time (joules or watts); Pf = the profile correction factor (for uniform or gaussian irradiance profile); ΜPΕ = Maximum Permissible Exposure, in energy density units (J/cm 2 ), or power density units (W/cm 2 ); NOHD = the Nominal Ocular Hazard Distance (cm) (measured from the beam waist) = (the distance required to reduce the average energy density within 7mm) = (aperture centered on the beam to less than the MPE energy density). Er:YSGG Laser Nominal Ocular Hazard Distance Minimum Optical Density for Protective Eyewear Maximum Permissible Exposure Beam Divergence FDA Classification CDRH Classification European MDD Laser Classification 33 m at 2790 nm 2.5 or greater at 2790 nm 2.69* 10-4 W/cm 2 at 2790 nm 7.8 milliradians Class II Medical Device Class IV Laser Product Class IIb Class 4 Laser (IEC 60825:2007) WARNING - Never look directly into the Pearl Fractional handpiece while it is connected to the system, even if appropriate safety eyewear is being worn.

43 37 Additional Ocular Protection WARNINGS Never substitute non-laser prescription eyewear for appropriate laser safety eyewear, as severe damage to the eyes can 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 or handpiece aperture while the system is energized. Severe eye damage can occur. Turn off the system before inspecting any delivery system or laser component. Safety WARNING - Do not use this system in the presence of flammable or explosive material such as anesthetics, alcohol, surgical preparation solutions, and similar substances as explosion and/or fires can result. CAUTIONS The Pearl Fractional handpiece is intended solely for licensed practitioners trained in its proper use. When the system is not in use, the key should be removed to protect against unspecified use. Use of controls, adjustments or performance of procedures other than those specified herein may result in hazardous laser light radiation exposure.

44 38 Protecting Non-target Tissues WARNINGS The system must always be in STANDBY mode, except during actual treatment. Maintaining the system in the STANDBY mode prevents accidental laser light exposure if the footswitch is inadvertently pressed. Never place hands or other objects in the path of the Pearl Fractional handpiece treatment beam. CAUTION - Prevent accidental laser light discharge by turning off the system before connecting or disconnecting the Pearl Fractional handpiece. Electrical Hazard The system is grounded through the grounding conductor in the power cord, and is essential for safe operation. NOTE - Only authorized Cutera Service Representative is to perform service on any Cutera console or handpiece. WARNING - To ensure your safety, the following must be adhered to: 1. Do not remove the exterior housing, as high voltages are present inside the system. 2. Do not attempt to perform maintenance other than that which is outlined in this operator manual and the primary operator manual for the associated console. 3. Turn off the system and disconnect from the power source before doing system maintenance.

45 39 Fire Hazard WARNINGS 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. End of Life Disposal - Environmental Information The Pearl Fractional handpiece 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).

46 40 Regulatory Compliance All Cutera aesthetic platforms are designed to comply with the following: European Communities Medical Devices Directive 93/42/EEC US Federal Performing Standards 21 CFR and , IEC 60601, IEC , IEC , IEC , IEC , IEC and CAN/CSA 22.2 no M90 CE-labeled devices comply with all appropriate regulations as required in Annex II of the European Medical Device Directive MDD 93/42/EEC. Location of Controls Operation and adjustment controls are located so that the user need not be exposed to laser light during operation or adjustment. Although, there are no controls or adjustments on the Pearl Fractional handpiece, additional information on controls and adjustments on the console can be found in the primary operator manual, and you should become familiar with these various controls and adjustments. Protective Housing The Pearl Fractional handpiece has a protective housing that prevents unintended human access to laser radiation above Class I limits. The protective housing can only be opened by a Cutera-Certified representative. Electronic Fault Detection Circuitry If the console electronic system detects a fault condition, the system is placed into STANDBY and the high voltage power supply and footswitch are disabled, preventing treatment beam exposure to occur. READY mode and treatment beam exposures are not available until the fault condition is cleared. Some fault conditions may be cleared by the operator. Refer to the Troubleshooting Guide in this manual for additional information.

47 41 Electromagnetic Compatibility Like other electrical medical equipment, the Pearl Fractional handpiece requires special precautions to ensure electromagnetic compatibility (EMC) with other electrical medical devices. To ensure electromagnetic compatibility, the Pearl Fractional handpiece must be installed and operated according to the EMC information provided in this manual. NOTE - The Pearl Fractional handpiece design complies with IEC (Edition 3) requirements for EMC with other devices. CAUTION - Portable and mobile RF communications equipment may affect the normal function of the Pearl Fractional handpiece. WARNINGS Do not use cables or accessories other than those provided with the Pearl Fractional handpiece, as this may result in increased electromagnetic emissions or decreased immunity to such emissions. If the Pearl Fractional handpiece is used adjacent to or stacked with other equipment, observe and verify normal operation of the Pearl Fractional handpiece 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 Pearl Fractional handpiece. Guidance and Manufacturer s Declaration: Electromagnetic Emissions Pearl Fractional handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of Pearl Fractional handpiece should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment: Guidance RF emissions CISPR 11 Group 1 Pearl Fractional handpiece uses RF energy only for its internal function; therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Harmonic emissions IEC Class B Class A Pearl Fractional handpiece is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply Voltage Fluctuations/flicker emissions IEC Complies network that supplies buildings used for domestic purposes.

48 42 Guidance and Manufacturer s Declaration: Electromagnetic Immunity Pearl Fractional handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of Pearl Fractional handpiece should ensure that it is used in such environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment: Guidance Electrostatic Discharge (ESD) IEC ±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 IEC ±2kV for power supply lines ±1kV for input/output lines ±2kV line to ground ±kv line to line Mains power quality should be that of a typical commercial or hospital environment. Surge IEC ±1kV differential mode ±2kV common mode ±0.5, 1kV differential mode Mains power quality should be that of a typical commercial or hospital environment. ±0.5, 1, 2kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC <5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec. <5% Ut (95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <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 Pearl Fractional handpiece requires continued operation during power mains interruptions, it is recommended that Pearl Fractional handpiece be powered from an uninterruptible power supply or a battery. Power frequency (50/60Hz) magnetic field IEC 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.

49 43 Guidance and Manufacturer s Declaration: Electromagnetic immunity Pearl Fractional handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of Pearl Fractional handpiece should ensure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment: Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Pearl Fractional handpiece, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC Vrms 150kHz to 80 MHz 3 V Recommended Separation Distance d = 1.17 P d = 1.17 P 80MHz to 800MHz d = 2.33 P 800MHz to 2.5GHz Radiated RF IEC V/m 80MHz to 2.5 GHz 3 V/m 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 Pearl Fractional handpiece is used exceeds the applicable RF compliance level above, the Pearl Fractional handpiece should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Pearl Fractional handpiece. (b) Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3V/m.

50 44 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Pearl Fractional Handpiece The Pearl Fractional handpiece is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Pearl Fractional handpiece can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pearl Fractional handpiece 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 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.17 P d = 1.17 P d= 2.33 P 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.

51 45 Operational Training WARNING - Do not allow untrained or unqualified personnel to use the system at any time. CAUTIONS 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. Do not attempt to use this handpiece or associated consoles until the staff have been properly trained on system operation by certified personnel and have read this manual thoroughly. In addition to laser safety training of personnel, you should consider adopting a training and safety program as outlined by the latest ANSI Standard Z , the American National Standard for the Safe Use of Lasers in Health Care Facilities. You should also keep current with all relevant medical literature.

52 46 Operational Safety WARNINGS The Pearl Fractional handpiece is a sensitive instrument and should not be dropped. If the handpiece is dropped, you must carefully examine the handpiece for any physical damage prior to use. In addition, verify that the handpiece aiming beam scans properly. Do not allow untrained or unqualified personnel to use the system at any time. Never point the handpiece(s) at reflective objects, such as jewelry or smooth metal surfaces. Never fire the Pearl Fractional handpiece while the handpiece is directed into free space. CAUTIONS Inspect all protective eyewear, cables and handpieces for any damage, excessive wear, or wire damage that could affect system performance or safe operation, prior to each use of the system. Do not place any unnecessary stress on the umbilical cable(s) (i.e., pulling, tightly bending, or twisting the handpiece). Always verify that the treatment parameters are correct before placing the system into READY. Do not leave the system in READY mode when not in use. Always place the system in STANDBY between treatments or when treatments are not being performed. Before placing the system in READY mode, confirm that the Pearl Fractional handpiece emission aperture or window is safely positioned to prevent unintended treatment exposure. The system should always be in STANDBY mode until the Pearl Fractional handpiece is safely positioned for the area to be treated.

53 47 Smoke Evacuation-Laser Plume Pollution Hazard WARNING - Laser plume obscures the operative field and is noxious to those who come in contact with it. The plume presents a possible pollution hazard and should be effectively evacuated. Users are advised to consider the following: A commercial smoke evacuator designed for use with aesthetic lasers may be used; these are usually most effective when the plume is extensive. The vacuum tubing or probe used to evacuate the laser plume should not be used to any other substance except what it is designed for. Special in-line vacuum systems designed for evacuation of the laser plume may be installed. Flow capabilities should be adequate to effectively remove the laser plume.

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55 49 Clinical Applications Indications for Use The Pearl Fractional handpiece is indicated for skin resurfacing and coagulation. Contraindications for Use Pregnant patients Patients undergoing treatment for skin cancer

56 50 Precautions History of keloids or hypertropic scarring Diabetes - May impede wound healing History of herpes - Pre-Treatment with an antiviral may be indicated Isotretinoin (Accutane/Roaccutane) use History of vitiligo Expected Transient Events and Possible Adverse Effects Erythema and edema may occur following treatment and typically resolve within one month. A persistent grid pattern may be apparent on the treated skin and usually resolves with time. In rare cases, it may be permanent. Hyperpigmentation, hypopigmentation, burns, erosion, or blistering may occur, some of which may result in scarring. These complications are usually due to the use of excessive energy levels. Patients are more susceptible to irritation or infection following procedures that disrupt the surface of the skin. If this occurs, it is important to properly diagnose and treat these conditions to avoid delayed wound healing, scarring, or spread of an infection. Treatment for these conditions often requires prescriptive medications.

57 51 Treatment Precautions The Pearl Fractional handpiece and compatible consoles should only be operated by qualified personnel who have received appropriate training. In addition to the information provided in the Safety and Regulatory section, the following safety precautions are recommended: Guard against accidental exposure to laser light energy. Instruct all staff members to carefully direct the treatment beam only at the targeted treatment areas. Ensure that the patient and all staff personnel in the treatment room wear appropriate protective eyewear. The eyewear must provide adequate protection from light at the wavelength(s) being used. Refer to the Safety and Regulatory section for protective eyewear requirements. Instruct all staff members and patients to never look directly into the pulsed laser light or reflective surfaces, even when wearing proper protective eyewear. WARNING - Never allow anyone near the system while the system is in use without proper protective eyewear. Unprotected pulsed laser light exposure could cause permanent eye damage to either users or patients. See the Safety and Regulatory section in the aesthetics platform operator manual and the Eyewear Specifications topic in the Safety and Regulatory section of this manual for detailed information.

58 52 Patient Information The user should conduct a patient consultation, including a complete medical history and exam, prior to treatment. At that time, the user should also discuss all of the potential benefits, complications, options, and risks. Treatment Information for Skin Rejuvenation Procedures Refer to the Pearl Fractional Handpiece Treatment Guidelines (D0703) and the Cutera Clinical Training CD (D0725) accompanying this operator manual for treatment-specific information. These guidelines can also be obtained from your local Cutera representative. WARNING - Extreme caution should be used when treating near the eyes, taking care to avoid ocular damage from laser light energy. Patient eye protection appropriate for the treatment should be used.

59 53 Specifications Pearl Fractional Specifications Specifications subject to change without notice. Treatment Beam Type Wavelength Energy per Pulse Er:YSGG 2790 nm <400 mj Pulse Duration 1000 µs Repetition Rate Output Power Delivery System 20 Hz 20 W User-detachable laser handpiece with umbilical cable Spot Size 300 µm Aim Diode nm NOTE - All specifications on output power and pulse widths are ±20%.

60 54 Physical Parameters Handpiece Size: 6 in x 8 in x 2.5 in (15 cm x 20 cm x 6.3 cm) Handpiece Weight: 19 oz Operating length of umbilical: 6.5 ft (2 m) Minimum bend radius of umbilical: Storage 5 in (126 mm) Momentary 2 in (50 mm) Environmental Requirements Operational: Temperature: Humidity: 5º C to 30º C 0 to 80%, non-condensing Non-Operational: Temperature: Humidity: -10º C to 50º C (coolant drained) 0 to 90%, non-condensing Classifications FDA Classification CDRH Classification Class II Medical Device Class IV Laser Product European MDD Class IIb Laser Classification Class 4 Laser (IEC 60825:2007)

61 55 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 the appropriate label(s) below. Please refer to the appropriate primary operator manual for the location and meaning of other additional compliance labels. INVISIBLE AND VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION Output: 2 J Max at 2790 nm Duration: s Class 4 Laser Product Per IEC :2007 Aim Beam: 1 mw Max at 650 nm, Class 2 Danger Label (affixed to the side of the handpiece connector) P-XXXX Serial Number Label Cutera Inc 3240 Bayshore Blvd. Brisbane, CA U.S.A. Manufacturer Address Label (affixed to the underside of the handpiece connector)