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perator
anual
GenesisPlus Operator Manual
D1151, R
C, 10/16
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Summary of Contents for Cutera GenesisPlus

  • Page 1 GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 2 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.
  • Page 3: Table Of Contents

    ONTENTS PERATION Introduction 1 System Preparation 2 GenesisPlus System Components 3 System Console 4 Footswitch 4 Remote Interlock Plug 4 Handpiece 4 Connecting the System Components 5 Connecting the Footswitch 5 Inserting the Remote Interlock Plug 5 Connecting the Main Power Cable 5...
  • Page 4 Physical Parameters 41 Electrical Requirements 42 Environmental Requirements 42 Classifications 42 Eye Safety 42 Calibration Procedure 43 Equipment Required 43 Calibration Instructions 44 End of Life Disposal - Environmental Information 44 Warranty Information 44 GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 5 Clinical Guidelines 61 Dermatology 62 Podiatry 63 Patient Information 63 A - L PPENDIX ASER ARNING B - S PPENDIX YMBOLS C - B PPENDIX IBLIOGRAPHY D - C PPENDIX UTERA IRECT FFICE OCATIONS GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 6 THIS PAGE IS BLANK GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 7: Operation

    Civatte, reduction of scars and wrinkles, removal of warts, and the temporary increase of clear nail in patients with onychomycosis. The effects of the GenesisPlus laser for rejuvenation are documented in multiple peer-review published studies where the result is smoother skin with reduced erythema, decreased wrinkles, decreased pore size and an improvement in overall skin quality.
  • Page 8: System Preparation

    System Preparation The GenesisPlus 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 in-service and training to ensure that your staff is experienced with appropriate performance and safety considerations.
  • Page 9: Genesisplus System Components

    GenesisPlus System Components The GenesisPlus system consists of a system console, a laser handpiece, a handpiece cradle, a touchscreen control panel and a footswitch. Other components necessary for operation, such as a remote interlock plug and all electrical cables, are also included.
  • Page 10: System Console

    The handpiece delivers laser energy from the system console to the treatment site. An inte- grated temperature sensor and LED temperature indicators enable thermal monitoring of the target tissue. A working distance beam ensures proper positioning of the handpiece when cen- tered within the aiming beam. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 11: Connecting The System Components

    Connecting the System Components Before connecting the GenesisPlus 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 sec- tion of this operator manual.
  • Page 12 Insert the main power cord plug into the appropriate wall socket and turn the main electri- cal service ON. Ensure that the main power circuit breaker is in the up (ON) position. Power cable wrap Footswitch receptacle Main power circuit breaker Interlock receptacle Power cable receptacle GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 13: System Basics

    Upon release, the key automatically springs back to the l (ON) position. Keyswitch The start-up screen (Cutera name) appears, and the system begins a self-test routine. After approximately 10-15 seconds, the system emits an audible tone, the self-test message disap- pears, and the touchscreen displays the Genesis Control Screen.
  • Page 14: Emergency Off

    Place the handpiece into the pouch attached to the system console. Replace the vented filler cap with a sealed filler cap to prevent water from leaking. Unlock the console wheels by disengaging the wheel locks. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 15 Moving the system using the handpiece or umbilical may irrepara- bly damage the handpiece and/or the umbilical. Lock each of the system console wheels by engaging each wheel lock. Filler cap Wheel locks GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 16: General System Functions

    Memory storage Target tissue and recall buttons temperature display STANDBY button READY button Aiming beam Pulse counter display adjustment button and reset button Genesis Control Screen (STANDBY mode) GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 17: Warts Control Screen

    Warts Control Screen (STANDBY mode) CAUTION Do not treat any indications other than warts from the Warts Con- trol Screen. NOTE Press the (back) button to return to the Genesis Control Screen. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 18: System Status: Standby And Ready Modes

    • the temperature sensor and LED temperature indicators are functional • the (standby) button and the borders around the treatment parameter displays are highlighted in yellow Press to go to READY mode To select READY mode, press the (ready) button. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 19 WARNING Verify that all persons in the treatment room are wearing the appro- priate treatment beam safety eyewear before placing the system in READY mode. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 20: Treatment, Aiming And Working Distance Beams

    Treatment, Aiming and Working Distance Beams The GenesisPlus system produces three separate laser beams: • a treatment beam • an aiming beam • a working distance beam Temperature sensor (not visible) Working distance beam Aiming beam and treatment beam (not visible)
  • Page 21 3.7 cm and at the correct distance to obtain an accurate temperature reading of the tar- get tissue. The intensity of the working distance beam can be adjusted from the Information & Adjust- ment Screen. (refer to the Information & Adjustment Screen subtopic) GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 22: Memory Storage

    Any existing treatment parameters stored in memory will be overwritten with the new parameters. To recall previously stored settings, press and release either button. Buttons for storing and recalling settings GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 23: Thermal Monitoring

    35 - 38º C Yellow 39 - 42º C Yellow 43 - 46º C 47 - 50º C NOTE To obtain an accurate temperature reading, you must position the working distance beam within the aiming beam. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 24 The measured temperature of the target tissue also displays on the Genesis Control Screen. Measured temperature of target tissue GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 25: Information & Adjustment Screen

    Number of low energy pulses ever recorded Touchscreen backlighting controls Laser emission indicator/ Versions of system audible tones volume software used controls Audible pulse counter Working distance beam interval control intensity controls Information & Adjustment Screen GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 26: Audible Tones

    Audible Tones The GenesisPlus system emits an audible tone with every control screen selection, when an error condition has occurred, as well as at set exposure intervals. Additionally, an audible laser emission tone is generated during treatment exposure. The volume of audible tones can be increased from the minimum setting up to a setting where the tones can be clearly heard over the system sound level.
  • Page 27: Audible Pulse Counter

    Audible Pulse Counter The GenesisPlus system emits three distinct audible tones that correspond with user-selected pulse intervals. There are two pulse interval settings: 25/100/500 and 100/1000/5000. When the 25/100/500 setting is selected, the system emits a distinct tone when it reaches mul- tiples of 25 pulses, a second distinct tone when it reaches multiples of 100 pulses and a third distinct tone when it reaches multiples of 500 pulses.
  • Page 28: Pop-Up Screen

    If the error is successfully cleared, the pop-up screen can be cleared by pressing the (back) button. 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 D). GenesisPlus Operator Manual D1151, R...
  • Page 29: Displays And Indicators

    Displays and Indicators The GenesisPlus system also includes various indicators and controls to ensure safe and accu- rate operation. • A pulse counter display and (reset) button. The system will record the total number of laser pulses that the system has fired since the counter was most recently reset.
  • Page 30: User-Selectable Parameters

    User-selectable Parameters In pulsed lasers, such as GenesisPlus, fluence and pulse width affect the nature of laser-tissue interaction. The GenesisPlus system has sufficient laser peak power to allow for a wide range of fluence and pulse width combinations, enabling you to select optimal tissue interaction parameters.
  • Page 31: Selecting The Pulse Width

    Changing one or both of the other parameters may enable you to select the desired treatment setting. Pulse Width Controls/Display on Genesis Control Screen Pulse Width Controls/Display on Warts Control Screen GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 32: Selecting The Repetition Rate (Genesis Mode Only)

    There is no repetition rate setting in Warts mode, because the treat- ment of warts typically requires only a few laser exposures. After each exposure, observe the tissue response before proceeding. Repetition Rate Controls/Display on Genesis Control Screen GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 33: Aintenance

    Remote interlock...verify that the remote interlock plug is inserted into the interlock recep- tacle. If the remote interlock plug is used in conjunction with an external door switch, ver- ify that the treatment room door is closed. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 34 Treatment beam is not present, although aiming beam operates properly. Probable Cause: There is an internal laser system failure. Suggestion: Contact Cutera Service (refer to Appendix D). Treatment and aiming beams are not present. Touchscreen displays and indicators are normal. Probable Cause: The system is in STANDBY mode.
  • Page 35 Go to READY mode and adjust the aiming beam intensity on the Genesis or Warts Control Screen. If adjusting the aiming beam does not resolve the problem, contact Cutera Service (refer to Appendix D). “Connect Footswitch” advisory pop-up screen appears on the touchscreen with its corresponding error code(s).
  • Page 36 Check to see if the aiming beam is present. Clean the lens as described in this manual. If the problem is not resolved, contact Cutera Service (refer to Appendix D) for lens replacement. GenesisPlus Operator Manual...
  • Page 37: Error Code Guide

    Series 300 Codes - Series 300 codes indicate a “permanent fault” and the sys- tem must be powered off and restarted in order to clear the code. If this action fails to clear the code, contact Cutera Service (refer to Appendix D) to schedule an appointment.
  • Page 38: Annual System Maintenance

    Preventive maintenance, safety, power and calibration checks should be performed annually by a Cutera-certified service engineer to ensure proper laser performance. System Repair All system repairs should be performed by a Cutera-certified service engineer. For training and information, contact your local Cutera representative. Routine User Maintenance...
  • Page 39: Clean The External Surfaces Of The System Console

    Do not attempt to sterilize the handpiece. Damage will occur if the handpiece is autoclaved, immersed or otherwise handled improp- erly. 1. Sani-Cloth Plus and Sani-Cloth HB are registered trademarks of Professional Disposables International, Inc. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 40: Inspect And Clean The Handpiece Lenses

    Debris from patients can accumulate on the lenses. Therefore, it may be necessary to clean the lenses periodically during treatment. Clean the handpiece lenses using a clean wood stick cotton swab and lens-cleaning grade ace- tone, as described below. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 41 If necessary, shake off the excess acetone prior to cleaning the lenses. Gently wipe the surface of each lens. Inspect the lenses. If necessary, clean the lenses again with new cotton swabs. If the lenses cannot be cleaned, contact Cutera Service (refer to Appendix D) for lens replace- ment. NOTE The lenses must be clean before treating a patient.
  • Page 42: Inspect And Clean The Heat Exchanger Intake

    Repeat on the opposite side of the console to ensure that the entire heat exchanger intake is clean. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 43: Fill The Coolant Reservoir

    Replace the fill cap. CAUTION Ensure that the fill cap has a small hole to vent the system. A simi- lar fill cap without a vent hole is used to transport the system. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 44: Remote Interlock Pin Assignments

    Signal Name Signal Description Return Connect to switch common Remote Interlock Connect to Switch, Normally Open None No Connection None No Connection Remote Interlock pin assignments (mating face shown) GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 45: Electrical Utilities

    Grade” (NEMA L-20P or NEMA L-30P). The system can be installed with a removable or lockable wall plug. The 120 VAC configuration may be changed to a 220 VAC configuration. This internal change must be made by a Cutera-certified service representative. Call your Cutera representative for information.
  • Page 46: Removable Or Lockable Wall Socket And Plug Configurations

    250V wall socket and lockable plug combination must comply with EN 60309 (=IEC 309). The wall socket and plug combination must meet the following specifications: Plug: MK LN 9024, 16A 220V, IP67, IEC 309 Wall Socket: MK LN 9324, 16A 220V, IP67, IEC 309 GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 47: System Specifications

    .33 m X .46 m X .96 m (13 in X. 18 in X. 38 in) Weight: 61 kg (135 lb) Operating length of umbilical: 1.8 m (5.8 ft) Minimum bend radius of umbilical: Storage 12.6 cm (5 in) Momentary 5 cm (2 in) GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 48: Electrical Requirements

    2.69* 10 W/cm at 1064 nm GenesisPlus is designed to comply with the following: • US Federal Performance Standards 21 CFR 1040.10 and 1040.11 for Class IV Laser Products and IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825.
  • Page 49: Calibration Procedure

    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 set- tings.
  • Page 50: Calibration Instructions

    End of Life Disposal - Environmental Information The GenesisPlus 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.
  • Page 51: Afety And

    ANSI Z136.3-2005, ANSI Z136.1-2007 or European Standard EN 60825:2007, Appendix A. The GenesisPlus system is a Class IV Laser Product as defined by the U.S. Code of Federal Regulations and a Class 4 Laser Product as defined by the European Communities Medical Devices Directive.
  • Page 52 All personnel operating GenesisPlus or in the vicinity of the system, including the patient, staff personnel and observers, should wear protective eyewear with sufficient protection (optical density or shade factor specified in System Specifications or greater) for the 1064 nm Nd:YAG wavelength.
  • Page 53: Additional Ocular Protection

    Never look directly into any optical lens, optical fiber, handpiece or laser system aperture while the system is energized. Severe eye damage could occur. Turn off the system before inspecting any delivery system or laser component. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 54: Additional Safety Considerations

    Electrical Hazard • High voltages are present inside the system. Do not remove the exterior housing. • Only an authorized Cutera service representative should perform service on the system. • Do not attempt to perform maintenance other than that which is outlined in this manual.
  • Page 55: Fire Hazard

    Regulatory Compliance Cutera lasers comply with 21 CFR Chapter I, Subchapter J, as administered by the Center for Devices and Radiological Health of the US Food and Drug Administration (FDA). CE-Labeled devices comply with all appropriate performance standards as required in Annex II of the European Medical Device Directive MDD 93/42/EEC.
  • Page 56: Remote Interlock

    Protective Housing The GenesisPlus system console has a protective housing that prevents unintended human access to laser radiation above Class I limits. The housing must be opened only by a Cutera- certified representative. NOTE No section of the protective system housing can be opened without special tools.
  • Page 57: Operational Training

    Cutera VIP website for available training options and resources. The Treatment Guidelines can also be obtained from your local Cutera representative or on the VIP 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...
  • Page 58 CAUTION Before placing the system in READY mode, confirm that the laser aperture on the handpiece is safely positioned to prevent unin- tended treatment exposure. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 59: Location Of Regulatory Compliance Labels

    (Refer to the following page for label illustrations. Refer to Appendix B for symbol descriptions.) 2D barcode Global Trade Identification Number (GTIN) (01)00816722021205 Date of Manufacture (11)YYMMDD (21)GPyyyyy Serial Number Unique Device Identifier (UDI) Label GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 60 5,824,023 N o tic e N o . 5 0 , d a te d J u n e 2 4 , 2 0 0 7 Cutera, Inc., 3240 Bayshore Blvd., Brisbane, CA 94005, USA Back Panel Label Certification...
  • Page 61: Electromagnetic Compatibility

    Consult the tables below for guidance in placing the GenesisPlus. Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The GenesisPlus is intended for use in the electromagnetic environment specified below. The customer or the user of the GenesisPlus should ensure that it is used in such an environment. Emissions test...
  • Page 62 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The GenesisPlus is intended for use in the electromagnetic environment specified below. The customer or the user of the GenesisPlus should ensure that it is used in such environment. Immunity Test IEC 60601 Test Level...
  • Page 63 RF transmitters, an electromagnetic site survey should be consid- ered,. If the measured field strength in the location in which the GenesisPlus is used exceeds the applicable RF compli- ance level above, the GenesisPlus should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the GenesisPlus.
  • Page 64 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the GenesisPlus The GenesisPlus is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the GenesisPlus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the GenesisPlus as recommended below, according to the maximum output power of the communications equipment.
  • Page 65: Linical Pplications

    The laser is also intended for the treatment of benign pigmented lesions. The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
  • Page 66: Contraindications For Use

    The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagro- phytes and/or yeasts Candida albicans, etc.). Contraindications for Use Contraindications for use: • Pregnant patients •...
  • Page 67: Expected Transient Events And Possible Adverse Effects

    • Deep tissue injury and prolonged wound healing may occur when treating warts. GenesisPlus 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 fol- lowing safety precautions are recommended during use of the system: •...
  • Page 68: Dermatology

    Dermatology GenesisPlus gives the user the flexibility to adjust the pulse width, repetition rate and fluence based on treatment area size, skin type and tan. The pulse width settings available with Gene- sisPlus are ideal for targeting very small chromophores, such as the papillary dermal plexus and enlarged capillaries, for the treatment of: •...
  • Page 69: Podiatry

    Prior 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. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 70 GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 71 Output: 100 J Max at 1064 nm Duration: 0.1-300 ms Aim Beam: ≤ 1 mW Max at 650 nm Class 4 Laser Product Per IEC 60825-1:2007 Aim Beam: Class 2 3002766 rA Nd:YAG Laser Warning Sign for GenesisPlus GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 72 APPENDIX A THIS PAGE IS LEFT BLANK GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 73 Control panel (next to red button) 417-5266 Standby Handpiece control screen 417-5264 Ready Handpiece control screen Cutera-defined Laser emission indicator Handpiece control screen DIN 18734 Handpiece control screen Fluence (J/cm DIN 18734 Pulse width (ms) Handpiece control screen GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 74 Touchscreen backlighting Information & Adjustment screen Cutera-defined Temperature target aiming beam Information & Adjustment screen adjustment Cutera-defined Audible pulse counter interval Information & Adjustment screen (toggles between interval settings of 25/100/500 or 100/1000/5000) GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 75 Rear panel label 15223-1 BS EN ISO Date of manufacture Rear panel label 15223-1 BS EN ISO Manufacturer Rear panel label 15223-1 BS EN ISO Authorized representative in the Rear panel label 15223-1 European Community GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 76 Rear panel label to sale by or on the order of a prac- titioner licensed by the law of the state in which he/she practices to use or order the use of the device. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 77 Trelles M, Alvarez X, Martin-Vázquez M, Trelles O, Velez M, Levy J-L, Allones I. Assessment of the Efficacy of Non-ablative Long-pulsed 1064-nm Nd:YAG Laser Treatment of Wrinkles Compared at 2, 4, and 6 months. Facial Plas Surg. 2005;21:145-153. GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 78 APPENDIX C THIS PAGE IS BLANK GenesisPlus Operator Manual D1151, R C, 10/16...
  • Page 79 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.
  • Page 80 APPENDIX D THIS PAGE IS LEFT BLANK GenesisPlus Operator Manual D1151, R C, 10/16...

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