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Cutera Excel HR, Руководство оператора

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This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not 
be copied in whole or in part or reproduced in any other media without the express written per-
mission of Cutera, Inc. Permitted copies must carry the same proprietary and copyright notices 
as were affixed to the original. Under the law, copying includes translations into another lan-
guage.

Please note that while every effort has been made to ensure that the data given in this docu-
ment is accurate, the information, figures, illustrations, tables, specifications, and schematics 
contained herein are subject to change without notice.

Cutera is the registered trademark of Cutera, Inc.

©December 2016 Cutera, Inc. 
Published in USA 
D1796 
Revision D

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

MDSS GmbH 
Schiffgraben 41, D-30175 
Hannover, Germany

Содержание Excel HR

Страница 1: ...Operator Manual...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 92: ...C 2 EXCEL HR OPERATOR MANUAL D1796 REV D 12 16...

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