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Cutera GenesisPlus Operator'S Manual Download Page 55

49

GenesisPlus Operator Manual

D1151, R

EV

C, 10/16

Fire Hazard

WARNING

Do not use this system in the presence of flammable materials,
solutions, or gases or in an oxygen-enriched environment. An
explosion and/or fire could occur.

WARNING

The high temperatures produced in normal use of the system may
ignite endogenous gases, as well as some materials (e.g., cotton
wool when saturated with oxygen). The solvents of adhesives and
flammable solutions used for cleaning and disinfecting should be
allowed to evaporate before the system is used.

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.

Location of Controls

Operation and adjustment controls are located so that the user need not be exposed to laser
radiation during operation or adjustment.

Key Lock Switch

To prevent unauthorized use, the system can only be turned on with the proper key. The key
cannot be removed while in the ON (or START) position and the system will only operate with
the key in place. When treatments are complete or the system is not is use, always remove and
store the key.

Emergency Off Push-button

The system can be immediately shut down, terminating laser emission, by pushing the red,
mushroom-shaped emergency off button that is located in the upper right hand corner of the
control panel. 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 will emit an audible tone and the laser emission
icon in the lower right hand corner of the touchscreen will illuminate yellow.

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Summary of Contents for GenesisPlus

Page 1: ...i GenesisPlus Operator Manual D1151 REV C 10 16 Operator Manual ...

Page 2: ...fixed 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 con tained herein are subject to change without notice Cutera is the registered trademark of Cutera Inc Cutera Inc Octobe...

Page 3: ...em 7 Restarting the System 7 Turning Off the System 7 Emergency Off 8 Disconnecting the System 8 Moving the System 8 General System Functions 10 Genesis Control Screen 10 Warts Control Screen 11 System Status STANDBY and READY Modes 12 Treatment Aiming and Working Distance Beams 14 Memory Storage 16 Thermal Monitoring 17 Information Adjustment Screen 19 Audible Tones 20 Audible Pulse Counter 21 Po...

Page 4: ...the Coolant Reservoir 37 Remote Interlock Pin Assignments 38 Electrical Utilities 39 Systems Designed for Use Outside of Europe 39 Systems Designed for Use in European Communities Under MDD 39 Removable or Lockable Wall Socket and Plug Configurations 40 Systems Designed for Use in European Communities Under MDD 40 System Specifications 41 Treatment Beam 41 Physical Parameters 41 Electrical Require...

Page 5: ...sing 50 Laser Safety Shutter 50 Audible Emission Indicator 50 Manual Reset 50 Electronic Fault Detection Circuitry 50 Operational Training 51 Operational Safety 51 Location of Regulatory Compliance Labels 53 Electromagnetic Compatibility 55 CLINICAL APPLICATIONS 59 Indications for Use 59 Dermatology 59 Podiatry 59 Contraindications for Use 60 Precautions 60 Expected Transient Events and Possible A...

Page 6: ...vi GenesisPlus Operator Manual D1151 REV C 10 16 THIS PAGE IS BLANK ...

Page 7: ...e 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 Key benefits Fast treatments three times faster than alternative Nd YAG lasers No recurring costs one time purchase only Large spot for uniform coverage ...

Page 8: ...e 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 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 t...

Page 9: ...tem 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 Footswitch System console Remote interlock plug Laser handpiece in handpiece cradle Touchscreen control panel ...

Page 10: ...ired to an external door switch shuts down the system power if the treatment room door is opened or the interlock plug is removed To resume treatment close the treatment room door or reinsert the remote inter lock plug and restart the system using the keyswitch Use of an external door switch is optional however the remote interlock plug must be inserted into the interlock receptacle at all times f...

Page 11: ...e the coating Connecting the Footswitch Plug the footswitch cable into the footswitch receptacle on the rear of the system con sole If the footswitch is not properly connected when the system is turned on a pop up screen with an animated illustration will be displayed on the touchscreen and the system cannot be placed into READY mode An illustration of the pop up screen is displayed later in this ...

Page 12: ...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 Footswitch receptacle Interlock receptacle Main power circuit breaker Power cable receptacle Power cable wrap ...

Page 13: ...lt conditions advi sory messages or error codes appear in the pop up display during self test refer to the Troubleshooting section of this operator 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 Sy...

Page 14: ...itch storage mount on the rear of the system console Coil the footswitch cable and store it inside the footswitch holder Do not wrap the footswitch cable around the power cable wrap Moving the System 1 Disconnect the system as described above WARNING Water must be drained from the system if the system is stored in temperatures below freezing Freezing may result in damage to crit ical or delicate c...

Page 15: ...ure or other equipment Adequate space around the system con sole ensures proper air circulation CAUTION Never use the handpiece or umbilical cord to move the system Moving the system using the handpiece or umbilical may irrepara bly damage the handpiece and or the umbilical 6 Lock each of the system console wheels by engaging each wheel lock Wheel locks Filler cap ...

Page 16: ...emperature of the target tissue refer to the Thermal Monitoring subtopic select the system status refer to the System Status STANDBY and READY Modes subtopic view and reset the pulse counter refer to the Displays and Indicators subtopic go to the Warts Control Screen refer to the Warts Control Screen subtopic go to the Information Adjustment Screen refer to Information Adjustment Screen subtopic G...

Page 17: ...s STANDBY and READY Modes subtopic view and reset the pulse counter refer to the Displays and Indicators subtopic go to the Genesis Control Screen refer to the Genesis Control Screen subtopic go to the Information Adjustment Screen refer to Information Adjustment Screen subtopic Warts Control Screen STANDBY mode READY button STANDBY button Memory storage and recall buttons Pulse width controls and...

Page 18: ... the footswitch is disabled the internal safety shutter is closed the treatment aiming and working distance beams are not available 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 ...

Page 19: ...the footswitch is depressed treatment energy is dis charged from the handpiece the system emits an audible tone and a yellow indicator next to the ready button illuminates to indicate laser emission If the system is not used for more than three minutes the system automatically goes into STANDBY mode WARNING Except during actual treatment the system must always be in STANDBY mode Maintaining the sy...

Page 20: ...le to the human eye Therefore an aiming beam is provided to enable accurate positioning of the treatment beam Aiming Beam The aiming beam is a low power visible laser beam that is coaxial with the invisible treatment beam and is used to target the treatment area All aiming beam functions are controlled from the touchscreen display There are four intensities in continuous and blink modes as well as...

Page 21: ...proper positioning of the handpiece When the working distance beam is centered within the aiming beam the handpiece is at the optimal working dis tance of 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 subt...

Page 22: ...eature allowing for storage of two separate sets of treatment parameters in both Genesis and Warts modes To store the treatment parameters shown on the display press and hold button or until the system beeps 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 reca...

Page 23: ...mine the average surface temperature of treated tis sue Three colors of LEDs are used to indicate temperature Each LED indicates a range of 4º C moving from dim to full illumination over the temperature range The following table shows the temperature ranges associated with each LED LED Color Temperature Range Green 26 30º C Green 31 34º C Green 35 38º C Yellow 39 42º C Yellow 43 46º C Red 47 50º C...

Page 24: ...18 GenesisPlus Operator Manual D1151 REV C 10 16 The measured temperature of the target tissue also displays on the Genesis Control Screen Measured temperature of target tissue ...

Page 25: ...Counter subtopic view the version of the system software view the total number of high and low energy pulses ever recorded NOTE High and low energy pulses refer to the amount of energy delivered to the lamp not to the treatment area High energy pulses are those that are greater than 800 J low energy pulses are those that are less than or equal to 800 J Information Adjustment Screen Laser emission ...

Page 26: ...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 To adjust the volume of audible tones press the tab on the Genesis or Warts Control Screen to go to the Information Adjustment Screen NOTE The volume of audible tones cannot be muted Controls for adjusting...

Page 27: ...ond distinct tone when it reaches multiples of 100 pulses and a third distinct tone when it reaches multiples of 500 pulses When the 100 1000 5000 setting is selected the system emits a distinct tone when it reaches multiples of 100 pulses a second distinct tone when it reaches multiples of 1000 pulses and a third distinct tone when it reaches multiples of 5000 pulses To select the audible pulse c...

Page 28: ...le Pop up Screen with Error Codes Depending upon the fault detected some faults will display an animated illustration e g con nect footswitch and water low Connect Footswitch 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 Ser...

Page 29: ...e 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 An emissions indicator The emissions indicator will illuminate when the system is set to READY and the footswitch is pressed Emissions indicator Pulse counter display Pulse counter reset button ...

Page 30: ...ined as energy per unit area and is measured in joules per square centimeter J cm2 Select the desired fluence by pressing the and buttons below the J cm2 display CAUTION The fluence shown on the fluence display indicates the fluence delivered to the tissue NOTE Laser parameters are interrelated Therefore not all combinations of fluence pulse width and repetition rate settings are simultane ously a...

Page 31: ...display NOTE Laser parameters are interrelated Therefore not all combinations of fluence pulse width and repetition rate settings are simultane ously available If you attempt to select a fluence pulse width or repetition rate setting that is not available the system emits a dis tinct audible tone Changing one or both of the other parameters may enable you to select the desired treatment setting Pu...

Page 32: ...isplay NOTE Laser parameters are interrelated Therefore not all combinations of fluence pulse width and repetition rate settings are simultane ously available If you attempt to select a fluence pulse width or repetition rate setting that is not available the system emits a dis tinct audible tone Changing one or both of the other parameters may enable you to select the desired treatment setting NOT...

Page 33: ...cal power source verify that the electrical disconnect switch the circuit breaker is turned on in the UP position 2 System console electrical verify that the system is on and properly connected to an elec trical service outlet 3 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...

Page 34: ...em main power circuit breaker in the ON up position Probable Cause The electrical outlet is defective Suggestion Use another outlet or have the outlet professionally tested and if appropriate repaired Probable Cause The remote interlock plug is not connected to the system console Suggestion Insert the remote interlock plug into the interlock receptacle then turn the keyswitch to the START position...

Page 35: ...a Service refer to Appendix D 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 NOTE Press the button to clear the advisory message System shuts down during operation with no touchscreen display Prob...

Page 36: ...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 topic Restart the system to continue with treatments Low or no energy output patient reports no sensation Probable Cause Handpiece lens is dirty or damaged Suggestion Confirm that laser energy is not being emitted on the test area such as on an arm...

Page 37: ... service of your system contact Cutera Service refer to Appendix D 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 treat ment or by pressing the button in the advisory pop up screen on the touch screen display If after pressing the button the code does not clear power off a...

Page 38: ...d service engineer For training and information contact your local Cutera representative Routine User Maintenance Clean the external surfaces of the system console Weekly or as needed Clean the system touchscreen display Weekly or as needed Clean the external surfaces of the handpiece Between each patient use Inspect and clean the handpiece lenses As needed Inspect and clean the heat exchanger int...

Page 39: ... to a soft cloth to clean the system touchscreen display CAUTION Do not spray or pour cleaning agents directly on the system console or control screen You may damage the console touchscreen and the system electronics Clean the External Surfaces of the Handpiece Clean the umbilical cable and handpiece housing as needed using a germicidal disposable wipe such as Sani Cloth Plus or San Cloth HB from ...

Page 40: ...ing the lenses Do not inspect the lenses while the system is in READY mode Always wear proper eyewear while the system is turned on Severe eye damage can occur in the event of unintended laser emission CAUTION If the lenses are not properly maintained debris can build up on the lens surfaces leading to permanent damage to the lenses and ulti mately permanent damage to the handpiece optical system ...

Page 41: ... is in STANDBY mode 2 Using a separate wood stick cotton swab for each lens place a small amount of acetone on both swabs If necessary shake off the excess acetone prior to cleaning the lenses 3 Gently wipe the surface of each lens 4 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 repla...

Page 42: ...ated 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 accumula tion 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 t...

Page 43: ...stem 1 Turn off the system 2 Remove the reservoir fill cap at the rear of the system 3 Add water to the reservoir Use only clean unused distilled water provided Carefully fill the reservoir Do not overfill 4 After the reservoir is full turn the system keyswitch to the START position and release to the ON position This engages the water pump allowing the coolant to be drawn into the cooling system ...

Page 44: ...rchase a replacement four pin Mini DIN Plug and an external door switch Connect the external door switch to the pin assignment found 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 2 1 Remote Interlock pin assignments mating face shown 4 ...

Page 45: ...on must be supplied from a dedicated 220 10 VAC single phase 50 60 Hertz source The wiring should be rated for 16 20 Amps as per local codes Hospital Grade NEMA L6 20P or NEMA L6 30P The system can be installed with a lockable wall plug Such a connection will ensure compliance with allowable leakage current levels per UL2601 for this device Leakage current for these systems does not exceed 500 A S...

Page 46: ...ll be responsible for ensuring that the proper electrical requirements are available at the site Systems Designed for Use in European Communities Under MDD To comply with the European Communities Medical Devices Directive 93 94 EEC the 16A 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 Plu...

Page 47: ...ition Rate Genesis mode Single shot to 10 Hz Warts mode Single shot only Delivery System Permanently attached umbilical and handpiece Treatment Spot 5 mm 0 2 in fixed circular spot Working Distance 3 4 cm 1 2 1 6 in System Cooling Self contained water to air heat exchanger Aiming and Working Distance Beams 650 nm Physical Parameters Size W X D X H 33 m X 46 m X 96 m 13 in X 18 in X 38 in Weight 61...

Page 48: ... 000 ft Classifications FDA Classification Class II Medical Device CDRH Classification Class IV Laser Product European MDD 93 42 EEC Laser Classification Class 4 Laser to IEC 60825 2007 Eye Safety Nominal Ocular Hazard Distance 81 m at 1064 nm Minimum Optical Density for Protective Eyewear 6 1 at 1064 nm Maximum Permissible Exposure 2 69 10 4 W cm2 at 1064 nm GenesisPlus is designed to comply with...

Page 49: ...ra 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 certi fied customer voids any existing manufacturer s warranty on the instrument A service manual for the GenesisPlus system may be purchased from the Cutera Service Department however posses sion of service inst...

Page 50: ...ed by unauthorized personnel will void all war ranties 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...

Page 51: ...rs are provided as a guide Individual treatments should be based on clinical training clini cal observation of laser tissue interaction and appropriate clinical endpoints Optical Hazard Laser safety eyewear is routinely required with most laser systems Personnel responsible for laser safety should determine the need for safety eyewear based on the Maximum Permissible Exposure MPE Nominal Hazard Zo...

Page 52: ...e 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 2007 Appendix A The ANSI and the Europe...

Page 53: ... 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 Additional Ocular Protection WARNING Never...

Page 54: ...Tissues WARNING Except during actual treatment the system must always be in the STANDBY mode Maintaining the system in the STANDBY mode prevents accidental laser exposure if the footswitch is inadvertently pressed WARNING Never place hands or other objects in the path of the laser beam Electrical Hazard High voltages are present inside the system Do not remove the exterior housing Only an authoriz...

Page 55: ...tion and adjustment controls are located so that the user need not be exposed to laser radiation during operation or adjustment Key Lock Switch To prevent unauthorized use the system can only be turned on with the proper key The key cannot be removed while in the ON or START position and the system will only operate with the key in place When treatments are complete or the system is not is use alw...

Page 56: ... Emission Indicator Each Nd YAG laser pulse delivered is accompanied by an audible tone In addition the system emits three distinct audible tones that correspond with user selected pulse intervals of either 25 100 500 pulses or 100 1000 5000 pulses Manual Reset If the system shuts down during operation due to electrical power loss depression of the emergency off button or opening of the door inter...

Page 57: ...lable 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 Standard for the Safe Use of Lasers in Health Care Facilities or an equiv...

Page 58: ...otective eyewear cables and the handpiece for any damage excessive wear or crimp ing that could affect system performance or safe operation CAUTION Do not place any unnecessary stress on the umbilical cable i e by pulling on it tightly bending it or twisting the handpiece See Sys tem Specifications topic for additional information on minimum bend radius CAUTION Always verify that the treatment par...

Page 59: ...l and international regulatory agencies appropriate regulatory compli ance labels have been mounted in specified locations All treatment room staff should be famil iar with the location and meaning of these labels Regulatory compliance labels Refer to the following page for label illustrations Refer to Appendix B for symbol descriptions DISTILLED WATER ONLY 01 00816722021205 11 YYMMDD 21 GPyyyyy 2...

Page 60: ... AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION Output 100J Max at 1064nm Duration 0 1 300ms Class 4 Laser Product Per IEC 60825 1 2014 Aim Beam 1 mW Max at 650 nm Class 2 Back Panel Label Certification label Warning of laser radiation from adjacent aperture Located on handpiece Laser Radiation Warning Emergency Stop Button Located on top of console next to red button Non interlock Ho...

Page 61: ...ion of the GenesisPlus 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 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 us...

Page 62: ...ode 0 5 1 2kV common mode Mains power quality should be that of a typ ical 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 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 ...

Page 63: ... an electromagnetic site sur vey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip ment 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...

Page 64: ...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 ...

Page 65: ...r the coagulation and hemostasis of benign vascular lesions such as but not limited to rosacea and poikiloderma of civatte and treatment of benign cutaneous lesions such as warts scars and straie 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 wri...

Page 66: ... skin cancer Precautions Photosensitizing drugs Tetracyclines etc Be aware that you may have to adjust the treatment parameters according to clinical response from test area s Anticoagulants May increase risk of purpura or bruising History of coagulopathies History of keloids or hypertrophic scarring Diabetes May impede wound healing History of herpes Pre treatment with an antiviral may be indicat...

Page 67: ... treatment room wear appropriate protective eyewear If the patient cannot wear protective eyewear be sure to fit the patient with opaque eye protection that will completely block light to the eyes The eyewear must provide adequate protection from 1064 nm Nd YAG laser radiation See the Safety and Regulatory section for protective eyewear requirements Instruct all staff members and patients to never...

Page 68: ...lines only and are not intended to replace good clinical judgment of the healthcare professional 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 enlarg...

Page 69: ...ngs 200 mJ 20 Hz s on s off Treatment Pass 1 Horizontal Pattern Holding the handpiece perpendicular to the infected toenail deliver a pattern of consecutive laser spots of 1 to 1 5 mm in diameter horizontally medial lateral direction over the entire surface of the toenail as well as to the skin approximately 2 mm beyond the perimeter edges of the toenail Treatment Pass 2 Vertical Pattern Holding t...

Page 70: ...64 GenesisPlus Operator Manual D1151 REV C 10 16 ...

Page 71: ...m 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 INVISIBLE ANDVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURETO DIRECT OR SCATTERED RADIATION USE PROPER EYEWEARWHEN OPERATING AND ORTREATING PATIENTS 3002766 rA Nd YAG Laser Warning Sign for GenesisPlus ...

Page 72: ...A 2 APPENDIX A GenesisPlus Operator Manual D1151 REV C 10 16 THIS PAGE IS LEFT BLANK ...

Page 73: ...l 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 Handpiece control screen 417 5264 Ready Handpiece control screen Cutera defined Laser emission indicator Handpiece control screen DIN 18734 Fluence J cm2 Hand...

Page 74: ...o previous screen Genesis Control Screen Warts Control Screen Information Adjustment screen Cutera defined Go to Information Adjustment Screen Handpiece control screen Cutera defined Volume of audible tones and indicators Information Adjustment screen Cutera defined Touchscreen backlighting Information Adjustment screen Cutera defined Temperature target aiming beam adjustment Information Adjustmen...

Page 75: ...a defined System display software version Information Adjustment screen 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 Manufactu...

Page 76: ...lectronic equipment must not be disposed as unsorted municipal waste and must be collected separately Rear panel label IEC 60601 Type BF equipment Rear panel label IEC 60825 1 Laser radiation warning Rear panel label and near laser aper ture on handpiece 21 CFR 801 109 US federal law restricts this device to sale by or on the order of a prac titioner licensed by the law of the state in which he sh...

Page 77: ...aser A 24 week Follow up Dermatol Surg 2010 36 1 8 Lipper G Perez M Non ablative Acne Scar Reduction after a Series of Treatments with a Short pulsed 1064 nm Neodymium YAG Laser Dermatol Surg 2006 32 998 1006 Sarradet D Hussain M Goldberg D Millisecond 1064 nm Neodymium YAG Laser Treatment of Facial Telangi ectasias Dermatol Surg 2003 29 56 8 Schmults C Phelps R Goldberg D Non ablative Facial Remo...

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Page 79: ...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 Building 3rd floor 12 10 Sakuragaoka Shibuya ku Tokyo 150 0031 Japan Tel 81 0 3 5456 6325 Fax 81 0 3 5456 2213 ...

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