Cutera Excel HR Operator'S Manual Download

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EXCEL HR OPERATOR MANUAL

D1796, REV. D, 12/16

Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Maximum Allowable Temperature of Accessible Parts . . . . . . . . . . . . . . . . . 45

Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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

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

1064 nm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

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

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Calibration Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

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

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

AFETY AND

EGULATORY

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

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

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

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

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

Protecting Non-Target Tissues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Electrical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

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

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

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

Location of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Key Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Emergency Off Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Laser Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Remote Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Protective Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Laser Safety Shutter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Audible Emission Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Manual Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Electronic Fault Detection Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Location of Regulatory Compliance Labels . . . . . . . . . . . . . . . . . . . . . . . . . 59

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

Summary of Contents for Excel HR

Page 1: ...Operator Manual...

Page 2: ...er the law copying includes translations into another lan guage Please note that while every effort has been made to ensure that the data given in this docu ment is accurate the information figures il...

Page 3: ...y of the Delivery System 2 System Components 3 System Console 3 Handpiece 3 Footswitch 3 Remote Interlock Plug 3 Connecting the System Components 5 Connecting the Footswitch 5 Inserting the Remote Int...

Page 4: ...perature of the Sapphire Cooling Window 25 Cleaning the Handpiece During Treatment 26 Treatments without gel 26 Treatments with gel 26 MAINTENANCE 29 Troubleshooting Guide 29 Error Code Guide 33 Annua...

Page 5: ...REGULATORY 49 Introduction 49 Optical Hazard 49 Additional Ocular Protection 51 Additional Safety Considerations 52 Protecting Non Target Tissues 52 Electrical Hazard 52 Fire Hazard 53 Operational Tr...

Page 6: ...verse Effects 69 Treatment Precautions 69 Treatments 70 Hair Removal Treatment Guidelines 71 Hair Removal Technique and Endpoints 73 Vascular Lesion Treatment Guidelines 73 Vascular Lesion Technique a...

Page 7: ...Cutera representative Any laser device can generate highly concentrated light which may cause injury if improperly used To protect patients and operating personnel read and comprehend this entire ope...

Page 8: ...te 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 sa...

Page 9: ...electronics laser source with associated optics and power supply The touchscreen control panel allows you to select treatment settings Handpiece The handpiece delivers laser energy from the system co...

Page 10: ...Footswitch Remote interlock plug Holster System console Boom Handpiece 4 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16...

Page 11: ...the footswitch cable into the footswitch receptacle on the rear of the system console If the footswitch is not properly connected when the system is turned on a pop up screen with an animated illustr...

Page 12: ...tem main power circuit breaker is off down and that the system keyswitch is in the O off position 2 Insert the mains power cord plug into the appropriate wall socket and turn on the main electrical se...

Page 13: ...sory messages or error codes appear in the pop up display during self test refer to the Troubleshooting section of this manual Restarting the System To restart the system 1 Turn the keyswitch to the O...

Page 14: ...wn position 3 Remove the power plug from the electrical outlet and wrap the power cable around the power cable wrap 4 Place the footswitch on the upper power cable wrap Coil the footswitch cable and s...

Page 15: ...ezing Freezing may result in damage to critical or delicate components 3 Unlock the console wheels by disengaging the wheel locks 4 Move the system console to the desired site Position the console no...

Page 16: ...splays and the system is automatically placed in STANDBY mode In STANDBY the footswitch is disabled and no treatment energy is available Touch the button for the desired wavelength to go to the corres...

Page 17: ...atment parameters refer to the Memory Storage topic view and reset the pulse counter refer to the Displays and Indicators topic select the system status refer to the System Status STANDBY and READY Mo...

Page 18: ...r and reset button Go to Information Adjustment screen Pulse width display and controls Repetition rate display and controls Spot size display and controls READY button Temperature display and control...

Page 19: ...ile using the laser handpiece adjust the volume of the emission indicator and other audible tones refer to the Audible Tones topic adjust the touchscreen backlighting adjust the aiming beam refer to t...

Page 20: ...BY button illuminates 755 nm Treatment Screen in STANDBY Mode Touch the READY button to toggle to READY mode In READY mode the footswitch is enabled the safety shutter is open the treatment and aiming...

Page 21: ...itch is inadvertently pressed Verify that all persons in the treatment room are wearing appropriate treatment beam safety eyewear before placing the system in READY mode If the console is not used for...

Page 22: ...ch the tab in the upper right corner of the Treatment screen to go to the Information Adjustment screen 2 Point the laser handpiece at the targeted treatment site 3 Touch the aiming beam button to tog...

Page 23: ...lse width and repetition rate settings currently displayed on the Treatment screen Touch and hold memory button 1 or 2 for less than three seconds to recall the previously stored treatment settings Wh...

Page 24: ...button The console records and displays the total number of treatment pulses delivered since the last button reset Emission indicator The emission indicator illuminates during treatment beam emission...

Page 25: ...the laser output is less than 80 of the requested energy the regular exposure tone is replaced by a lower pitched tone The volume of audible tones can be increased from the minimum setting up to a se...

Page 26: ...reen with Error Codes Depending upon the fault detected some faults display an animated illustration e g footswitch disconnected or water low Connect Footswitch Pop up Screen If the error is successfu...

Page 27: ...luence at appropriately small pulse durations to achieve selective photothermolysis effects Treatment parameters are interrelated Therefore not all parameter combinations are simultaneously available...

Page 28: ...er unit area and is measured in joules per square centimeter J cm2 Select the desired fluence by pressing the and buttons in the fluence field The fluence shown in the display indicates the fluence de...

Page 29: ...during which therapeutically effective treatment energy is delivered it is measured in milliseconds ms Select the desired pulse width by pressing the and buttons in the pulse width field The pulse wi...

Page 30: ...ou work Select the desired repetition rate by pressing the and buttons in the repetition rate field Location of Repetition Rate Controls and Display on 755 nm Treatment Screen Selecting the Spot Size...

Page 31: ...R handpiece features an integrated sapphire cooling window which allows you to adjust epidermal cooling to increase safety and efficacy Select the desired temperature of the cooling window by pressing...

Page 32: ...t Treatments without gel During treatment inspect the cooling window for debris and ejected hair Wipe the patient contact surface of the handpiece every 5 pulses with a cloth dampened with isopropyl a...

Page 33: ...Wipe the gel from back to front Do not handle the handpiece with gel covered gloves 27 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16...

Page 34: ...28 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16...

Page 35: ...nterlock plug is used in conjunction with an external door switch verify that the treatment room door is closed System does not turn on The touchscreen does not illuminate Probable Cause The system is...

Page 36: ...r no aiming beam Probable Cause The aiming beam is either set to OFF or at a low setting Suggestion Adjust the aiming beam intensity on the Information Adjustment screen If adjusting the aiming beam d...

Page 37: ...Suggestion Ensure that the footswitch is properly connected to the console Touch the back button in the upper left corner of the pop up screen to clear the advisory message Water Low advisory pop up...

Page 38: ...as been interrupted Suggestion Verify and or turn on the building power Probable Cause The system main power circuit breaker has tripped Suggestion Place the system main power circuit breaker in the o...

Page 39: ...ndix C Error Code Series Description Series 100 Codes Series 100 Codes appear as a warning and typically will not hinder treatment s Most Series 100 Codes are clearable by resuming treatment or by tou...

Page 40: ...ct and clean the handpiece During treatment as needed and between patient use Inspect and clean the handpiece holster Daily or as needed Cleaning the External Surfaces of the System Console Use a clot...

Page 41: ...lated 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...

Page 42: ...r any liquid other than de ionized or distilled water be used To completely fill the coolant reservoir in the system 1 Turn off the system 2 Open the reservoir door on the front of the system and remo...

Page 43: ...he system is approximately one half gallon Inspecting and Cleaning the Handpiece Inspect and clean the handpiece as described in the following sections In addition to the external surfaces of the hand...

Page 44: ...d handpiece lens is located at the distal end of the handpiece Prior to treatment as well as periodically during treatment inspect the lens for cracks and debris If the handpiece lens is cracked or ot...

Page 45: ...use acetone with 0 5 or lower water content which is available at most camera shops If unable to obtain acetone with 0 5 or lower water content contact Cutera Service refer to Appendix D Use only wood...

Page 46: ...is on Severe eye damage can occur in the event of unintended laser emission Inspecting and cleaning the cooling window is the responsibility of the practitioner If the cooling window is not properly...

Page 47: ...utput possibly leading to adverse events such as burns The proximal surface of the cooling window has a delicate optical coating take care to not scratch this surface Use a new germicidal disposable w...

Page 48: ...rom damage Do not attempt to remove the handpiece holster from the system in order to clean it Clean the inside of the holster with a germicidal disposable wipe To remove debris from grooved surfaces...

Page 49: ...a replacement four pin Mini DIN Plug and an external door switch Connect the external door switch to the pin assignment in the table below Pin Signal Name Signal Description 1 Return Connect to switc...

Page 50: ...void the risk of electric shock this equipment must only be connected to a supply mains with protective earth System Specifications Specifications subject to change without notice Treatment Beam Type...

Page 51: ...lant drained Humidity 0 to 90 non condensing Max Heat Dissipation 4 000 Watts Max Altitude Operating 15 000 ft Non operating 50 000 ft Atmospheric Pressure 20 to 110 kPa Maximum Allowable Temperature...

Page 52: ...associated with the excel HR refer to the Safety and Regulatory chapter of this manual 755 nm Nominal Ocular Hazard Distance NOHD 200 m Maximum Permissible Exposure MPE 2 81 10 4 W cm2 Minimum Optica...

Page 53: ...m 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 personne...

Page 54: ...ast page of the Terms and Conditions of Sale End of Life Disposal Environmental Information The system must be disposed of according to local laws and hospital practices This product is considered ele...

Page 55: ...ment parameters are provided as a guide Individual treatments should be based on clinical training clinical observation of laser tissue interaction and appropriate clinical endpoints Optical Hazard Sa...

Page 56: ...ollowing 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 E...

Page 57: ...ters for the specific medical application Depending on the procedure the physician must protect the patient s eyes with either laser safety eyewear or with diffuse metal eye shields Apply wet gauze ov...

Page 58: ...res other than those specified herein may result in hazardous laser radiation exposure Protecting Non Target Tissues Except during actual treatment the system must always be in STANDBY mode Maintainin...

Page 59: ...or safe operation 53 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16 Fire Hazard Do not use this system in the presence of flammable materials solutions or gases or in an oxygen enriched environment An exp...

Page 60: ...sonnel and have read this manual thoroughly Refer to the Treatment Guidelines accompanying this operator manual and to the Cutera website for available training options and resources The Treatment Gui...

Page 61: ...for the umbilical cable WARNING The handpiece is a fragile instrument and must not be dropped If it is dropped you must carefully examine the handpiece for any physical damage prior to use WARNING Ne...

Page 62: ...e on the handpiece is safely positioned to prevent unintended treatment exposure CAUTION The system should always be in the STANDBY mode until the handpiece is safely positioned at the area to be trea...

Page 63: ...in the l on or start position and the system will only operate with the key in place When the system is not in use always remove and store the key Emergency Off Button The system can be immediately sh...

Page 64: ...sound is emitted each time the pulse counter reaches a count that ends in 00 in order to indicate the delivery of 100 shot increments Manual Reset If the system shuts down during operation e g due to...

Page 65: ...nt room staff should be familiar with the location and meaning of these labels 01 00816722021502 11 YYMMDD 21 EHyyyyy Unique Device Identifier UDI Label 2D barcode Global Trade Identification Number G...

Page 66: ...pursuant to Laser Notice No 50 dated June 24 2007 INVISIBLE AND VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION Output 60 J Max at 755 nm 100 J Max at 1064 nm Durat...

Page 67: ...ng Label Located at lower corner on each side of console System OFF Located next to keyswitch System ON Located next to keyswitch Momentary Start Located next to keyswitch Tilting Hazard Label Located...

Page 68: ...excel HR in the configuration in which it will be used prior to using it in a surgical procedure Consult the tables below for guidance in placing the excel HR Guidance and Manufacturer s Declaration E...

Page 69: ...mode 0 5 1 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC610...

Page 70: ...lectromagnetic 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 an...

Page 71: ...uency 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 F...

Page 72: ...66 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16...

Page 73: ...duction is defined as the long term stable reduction in the number of hairs regrowing when measured at 6 9 and 12 months after the completion of a treatment regime Treatment of vascular lesions Treatm...

Page 74: ...ent treatments on malignant lesions Do not treat over tanned skin Treatment of tanned skin should be delayed to avoid complications Do not treat over or close to tattoos or permanent make up Hair remo...

Page 75: ...ed appropriate training In addition to the information provided in the Safety and Regulatory section of this manual the following safety precautions are recommended Guard against accidental exposure t...

Page 76: ...ng vascular lesions with the 755 nm or 1064 nm wavelength the blood temperature within the vessel is elevated to a temperature that causes coagulation of the vessel wall Since 755 nm and 1064 nm laser...

Page 77: ...Fine Hair Fluence Medium Hair Fluence Coarse Hair I II 4 8 C 3 ms 14 17 26 J cm 13 20 J cm 11 17 J cm 16 15 23 J cm 12 17 J cm 10 15 J cm 18 13 20 J cm 11 14 J cm 9 13 J cm III 4 C 3 ms 14 16 21 J cm...

Page 78: ...18 755 nm V 4 C 10 35 ms 10 35 55 J cm 12 30 50 J cm 15 25 40 J cm 18 20 30 J cm VI 4 C 10 40 ms 10 25 45 J cm 12 20 40 J cm 15 15 35 J cm 18 15 30 J cm 72 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16 W...

Page 79: ...Always observe the epidermis during the treatment watching for signs of damage e g blanching or gray coloration If damage is observed stop the treatment cool the skin and evaluate the area for possib...

Page 80: ...Pulse durations shorter than 10 ms increase the likelihood of purpura when treating vascular lesions 755 nm and 1064 nm 5 Window Temperature measured in Celsius The sapphire window provides pre paral...

Page 81: ...treating rounded bony areas Precool the skin to help prevent epidermal damage Ensure that each pulse receives both pre and postcooling The length of pre and postcooling required will vary according t...

Page 82: ...IV 5 mm 25 45 J cm 14 20 C 8 mm 15 35 J cm Dark Pigment I IV 5 mm 20 30 J cm 8 12 C 8 mm 15 25 J cm Seborrheic Keratosis I III 5 mm 20 50 J cm 16 20 C 8 mm 15 40 J cm Benign Pigmented Lesion Technique...

Page 83: ...action and clinical endpoints to determine appropriate parameters Protocol Spot Size Fluence Repetition Rate Pulse Duration Window Temperature A Low Energy Short Pulse Duration 7 mm 5 8 J cm 2 Hz 0 3...

Page 84: ...nformation 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...

Page 85: ...A 1 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16 Appendix A Laser Warning Sign excel HR Laser Warning Sign...

Page 86: ...A 2 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16...

Page 87: ...d control panel next to keyswitch 417 5008 Mains OFF Rear panel at circuit breaker and control panel next to keyswitch 417 5104 Momentary start Control panel next to keyswitch DIN 18734 Emergency OFF...

Page 88: ...play Cutera defined Spot size Touchscreen display Cutera defined Go to Information Adjustment screen Touchscreen display Cutera defined Return to previous screen Touchscreen display Cutera defined Vol...

Page 89: ...panel label BS EN ISO 15223 1 Manufacturer Rear panel label BS EN ISO 15223 1 Authorized representative in the European Community Rear panel label MDD 93 42 EEC CE Mark Rear panel label TUVus Mark Rea...

Page 90: ...Laser aperture Near laser aperture on handpiece IEC 60601 1 Tilting hazard do not push console over obstacle 10mm in height Side panels 21 CFR 801 109 US federal law restricts this device to sale by...

Page 91: ...4 CUTERA within US or 415 657 5500 outside US Service 866 258 8763 within US or 415 657 5500 outside US Fax 415 330 2444 Cutera APAC Cutera K K Shibuya Infoss Annex Bldg 3rd fl 12 10 Sakuragaoka Shib...

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