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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 permission 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 language.

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

Cutera is the registered trademark of Cutera, Inc.

©February 2019 Cutera, Inc.
Published in USA
D2325
Revision A

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

MDSS GmbH
Schiffgraben 41, D-30175
Hannover, Germany

Australian Sponsor

Cutera Australia, Pty. Ltd.
PO Box 774
Maroubra, NSW 2035

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Содержание Excel V+

Страница 1: ...I Operator Manual...

Страница 2: ...ions 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...

Страница 3: ...tics of the 1064 nm Laser Beam 2 System Preparation 2 excel V System Components 3 System Console 3 Handpieces 3 Footswitch 3 Remote Interlock Plug 3 Connecting the System Components 5 Connecting the F...

Страница 4: ...sis V Treatment Screen 19 Dermastat Treatment Screen 20 System Status STANDBY and READY Modes 21 Memory Storage 23 Information Adjustment Screen 24 Aiming Beam 25 Audible Tones and Voice Prompts 26 Di...

Страница 5: ...es of the System Console 57 Cleaning the System Touchscreen Display 57 Inspecting and Cleaning the Handpiece 58 Inspecting and Cleaning the External Surfaces of the Handpiece 59 Inspecting and Cleanin...

Страница 6: ...onmental Information 72 Warranty Information 72 SAFETY AND REGULATORY 73 Introduction 73 Optical Hazard 73 Additional Ocular Protection 75 Additional Safety Considerations 76 Protecting Non Target Tis...

Страница 7: ...87 CLINICAL APPLICATIONS 91 General Indications for Use 91 532 nm Indications 91 1064 nm Indications 91 Contraindications for Use 92 Warnings 92 Precautions 92 Expected Transient Events and Possible...

Страница 8: ...viii EXCEL V OPERATOR MANUAL D2325 REV A 2 19 THIS PAGE IS LEFT BLANK...

Страница 9: ...ign pigmented lesions The excel V is a precision medical instrument It has undergone extensive testing and with proper handling is a useful and reliable clinical instrument If you have any questions r...

Страница 10: ...s makes the 1064 nm laser useful for treating multiple indications See the Clinical Applications section for specific Indications for Use for the 1064 nm wavelength System Preparation The excel V syst...

Страница 11: ...motorized zoom and epidermal cooling The motorized zoom feature enables you to adjust the laser spot size The epidermal cooling feature allows you to adjust the temperature of the sapphire cooling wi...

Страница 12: ...4 EXCEL V OPERATOR MANUAL D2325 REV A 2 19 Boom CoolView Handpiece Genesis V Handpiece Footswitch Remote interlock plug System console Holsters Dermastat Handpiece Optional Standoff Tip...

Страница 13: ...erlock Plug Insert the remote interlock plug into the interlock receptacle on the rear of the system console The remote interlock plug must be inserted into the interlock receptacle at all times wheth...

Страница 14: ...6 EXCEL V OPERATOR MANUAL D2325 REV A 2 19 Remote Interlock Plug Footswitch...

Страница 15: ...pieces only 3 Remove the protective cap from the fiber connector 4 Insert the fiber connector into the fiber receptacle on the side of the system console ensuring that the alignment guide on the fiber...

Страница 16: ...eceptacle as follows 1 Align the dummy plug over the handpiece receptacle on the side of the system console and press down gently to align the fittings 2 Once aligned press down firmly until you hear...

Страница 17: ...ition 2 Insert the receptacle end of the power cable into the power cable receptacle on the system and insert the AC plug into the AC wall socket 3 Insert the mains power cord plug into the appropriat...

Страница 18: ...up screen and the system begins a self test routine After approximately two minutes the system emits an audible tone and the touchscreen displays the CoolView Select Screen the Genesis V Treatment Sc...

Страница 19: ...up sequence Turning Off the System Under normal operating conditions turn the keyswitch to the O OFF position Emergency Off In an emergency press the red emergency off button to immediately turn off t...

Страница 20: ...2 Remove the fiber connector from the fiber receptacle and replace the protective cap onto the fiber connector Disconnecting the Handpiece Connector or Dummy Plug To remove the handpiece connector or...

Страница 21: ...e console no less than 20 centimeters 8 inches from walls furniture or other equipment Adequate space around the system console ensures proper air circulation CAUTION Always disconnect the system as d...

Страница 22: ...14 EXCEL V OPERATOR MANUAL D2325 REV A 2 19 5 Lock each of the system console wheels by engaging each wheel lock Wheel locks...

Страница 23: ...in selecting the appropriate treatment parameters In expert mode you manually select parameters from a wide range of available settings on the CoolView Treatment Screen In navigation mode you first s...

Страница 24: ...t system start up To operate in navigation mode press the Tap here to Select 532nm Application or Tap here to Select 1064nm Application button Otherwise press the Tap here to Set Parameters button to...

Страница 25: ...utton on the CoolView Select Screen the CoolView Treatment Screen displays After pressing the Tap here to Select 532nm Application or Tap here to Select 1064nm Application button on the CoolView Selec...

Страница 26: ...laser spot size refer to the User selectable Parameters topic adjust the temperature of the sapphire cooling window refer to the User selectable Parameters topic view the actual temperature of the sap...

Страница 27: ...ic select the fluence pulse duration 532 nm only and repetition rate refer to the User selectable Parameters topic store and recall frequently used treatment parameters refer to the Memory Storage top...

Страница 28: ...reatment Screen you can select the fluence pulse duration and repetition rate refer to the User selectable Parameters topic store and recall frequently used treatment parameters refer to the Memory St...

Страница 29: ...nal safety shutter is closed no treatment or aiming beams are available the laser status button is amber Press the laser status button to toggle to READY mode In READY mode the footswitch is enabled t...

Страница 30: ...tem is not used for more than one minute the system automatically goes into STANDBY mode WARNING Except during actual treatment the system must always be in STANDBY mode Maintaining the system in STAN...

Страница 31: ...display 1 Press the memory button to display the memory pop up window 2 Press and hold number 1 2 or 3 in the memory pop up window until the system beeps Any existing treatment parameters stored in me...

Страница 32: ...sity and mode refer to the Aiming Beam topic adjust the working beam intensity Genesis V handpiece only refer to the Displays and Indicators topic view the versions of the system software go back to t...

Страница 33: ...e Information Adjustment screen 2 Point the handpiece at the targeted treatment site 3 Press the aiming beam button to display the aiming beam pop up window 4 Select the desired aiming beam setting fr...

Страница 34: ...s and voice prompts can be increased from the minimum setting up to a setting where the tones and prompts can be clearly heard over the system sound level To adjust the volume press the info button on...

Страница 35: ...cooling window A laser emission indicator illuminates when the system is set to READY and the footswitch is pressed On the Genesis V Treatment Screen A pulse counter records the total number of laser...

Страница 36: ...s the temperature of the target tissue and the LEDs indicate the measured temperature The following table shows the temperature ranges associated with each LED LED Color Temperature Range Red 47 50 C...

Страница 37: ...e is at the optimal working distance of 3 7 cm and at the correct distance to obtain an accurate temperature reading of the target tissue NOTE You can adjust the intensity of the working distance beam...

Страница 38: ...system has fired since the counter was last reset and a reset button allows you to reset the counter A laser emission indicator illuminates when the system is set to READY and the footswitch is press...

Страница 39: ...ction earlier in this chapter there are two user interface modes for use with the CoolView handpiece For instructions on operating in navigation mode proceed to the Selecting Treatment Settings in Nav...

Страница 40: ...erate in navigation mode press the Tap here to Select 532nm Application or Tap here to Select 1064nm Application button on the CoolView Select Screen or the CoolView Treatment Screen Location of Navig...

Страница 41: ...oolView Treatment Screen displays with the Skin Type menu open Press the button that corresponds to the patient s skin type The Treatment Category menu displays CoolView Treatment Screen with Skin Typ...

Страница 42: ...the desired treatment subcategory The CoolView Treatment Screen displays with the selected skin type treatment category and treatment subcategory displayed in the Navigation button and the recommended...

Страница 43: ...d application is unsupported for the currently selected wavelength Clear the message by pressing the button and then select the alternate wavelength by pressing the appropriate wavelength button at th...

Страница 44: ...screen After exiting navigation mode the CoolView Treatment Screen displays in expert mode You can either manually select parameters in expert mode as described in the following section or you can sel...

Страница 45: ...ton on the CoolView Select Screen After pressing the Tap here to Set Parameters button or after exiting navigation mode the CoolView Treatment Screen displays NOTE If you are currently in navigation m...

Страница 46: ...ect Screen press the Tap here to Select 532nm Application or Tap here to Select 1064nm Application button To select the wavelength from the CoolView Treatment Screen press the 532 nm or 1064 nm button...

Страница 47: ...en you reach the maximum spot size setting the button is disabled Changing the fluence and or pulse duration settings may make available a wider range of spot size settings CAUTION In navigation mode...

Страница 48: ...40 EXCEL V OPERATOR MANUAL D2325 REV A 2 19 CoolView Treatment Screen in Navigation Mode with Spot Size Setting Outside Recommended Range...

Страница 49: ...e shown in the Fluence display indicates the fluence delivered to the tissue NOTE When you reach the minimum fluence setting for the current treatment parameters the button is disabled when you reach...

Страница 50: ...nded range of settings for the specified skin type and application a black and yellow bar displays in the corresponding bar indicator to alert you that the setting is not recommended You are still abl...

Страница 51: ...ssing the and buttons next to the Pulse Duration display NOTE When you reach the minimum pulse duration setting for the current treatment parameters the button is disabled when you reach the maximum p...

Страница 52: ...easured in hertz Hz Select the desired repetition rate by pressing the or button next to the Rep Rate display NOTE When the repetition rate is set to the minimum setting the button is disabled When th...

Страница 53: ...ct the desired temperature setting from the temperature pop up window If you are in READY mode when you change the temperature setting the system will revert to STANDBY mode When you press the laser s...

Страница 54: ...uctions Selecting the Laser Wavelength The excel V features two wavelengths 532 nm and 1064 nm Select the wavelength by pressing the 532 nm or 1064 nm button at the bottom left corner of the screen Lo...

Страница 55: ...uttons next to the Fluence display CAUTION The fluence shown in the Fluence display indicates the fluence delivered to the tissue NOTE When you reach the minimum fluence setting for the current treatm...

Страница 56: ...erapeutically effective laser energy is delivered measured in milliseconds ms When using the Genesis V handpiece in 532 nm mode two pulse duration settings are available 0 5 ms and 1ms Select the desi...

Страница 57: ...easured in hertz Hz Select the desired repetition rate by pressing the or button next to the Rep Rate display NOTE When the repetition rate is set to the minimum setting the button is disabled When th...

Страница 58: ...isplay CAUTION The fluence shown in the Fluence display indicates the fluence delivered to the tissue NOTE When you reach the minimum fluence setting for the current treatment parameters the button is...

Страница 59: ...n by pressing the and buttons next to the Pulse Duration display NOTE When you reach the minimum pulse duration setting for the current treatment parameters the button is disabled when you reach the m...

Страница 60: ...easured in hertz Hz Select the desired repetition rate by pressing the or button next to the Rep Rate display NOTE When the repetition rate is set to the minimum setting the button is disabled When th...

Страница 61: ...l 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 el...

Страница 62: ...building power or reset the room circuit breaker Probable Cause The system main power circuit breaker is in the OFF down position Suggestion Place the system main power circuit breaker in the ON up p...

Страница 63: ...ement Ensure that the heat exchanger on the bottom of the system is free of dust and debris See the Routine User Mainte nance topic Ensure that the room temperature is below 27 C Probable Cause The bu...

Страница 64: ...rs such as connect footswitch and water low are accompanied by an animated illustration showing what action to take If the error or abnormal condition is successfully cleared the pop up screen can be...

Страница 65: ...oth or allow to air dry Cleaning the System Touchscreen Display Apply an alcohol based cleaner to a soft cloth to clean the system touchscreen display Clean the external surfaces of the system console...

Страница 66: ...tained CoolView handpiece recessed lens patient contact and proximal surfaces of cooling window Genesis V handpiece recessed lenses Dermastat handpiece recessed lens Proximal surface of cooling window...

Страница 67: ...is are dirty clean as directed below WARNING Before inspecting and cleaning the handpiece ensure that the system is either turned off or in STANDBY mode Always wear proper protective eyewear while th...

Страница 68: ...sposable wipes to clean the recessed lens es Doing so may damage the lens es and require handpiece replacement NOTE Debris from patients can accumulate on the lens es It may be necessary to clean the...

Страница 69: ...res below 4 Inspect the lens es If necessary clean the lens es again with a new cotton swab CAUTION The lens es must be clean before treating a patient Chips pits cracks or burned spots on the lens es...

Страница 70: ...nc During treatment clean the patient contact surface every 50 pulses or as necessary with 4x4 gauze if gel is used If gel is not used clean the patient contact surface every 5 pulses or as necessary...

Страница 71: ...face of the cooling window clear of gel by gently wiping periodically with 4x4 gauze Excessive top side gel may affect laser beam output possibly leading to adverse events such as burns 4 Inspect the...

Страница 72: ...erature related error code 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 cons...

Страница 73: ...eyswitch 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 5 Allow the system to run for 5 to 10 seconds 6 Turn...

Страница 74: ...ase 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...

Страница 75: ...or these systems does not exceed 500 A Systems Designed for Use in European Communities Under MDD In order to comply with the European Communities Medical Devices Directive 93 42 EEC and harmonized st...

Страница 76: ...stat 0 Hz single shot to 4 Hz CoolView 0 Hz single shot to 2 Hz Genesis V 0 Hz single shot to 10 Hz Treatment Spot CoolView 2 to 16 mm circular spot Genesis V 8 mm circular spot Dermastat 2 mm circula...

Страница 77: ...ency 50 60 Hz Environmental Requirements Temperature Operating 15 C to 30 C Non operating 10 C to 50 C coolant drained Humidity 0 to 90 non condensing Max Heat Dissipation 4 000 Watts Max Altitude Ope...

Страница 78: ...European MDD 93 42 EEC Laser Classification Class 4 Laser to IEC 60825 2014 Type BF Applied Part Handpiece Eye Safety Nominal Ocular Hazard Distance 1 45E 5 m at 532 nm 1 33E 5 m at 1064 nm Minimum Op...

Страница 79: ...Equipment Required Laser safety eyewear for all persons in the room with appropriate optical densities at the wavelengths being generated Laser energy meter Ophir Nova display unit model with L40 150A...

Страница 80: ...l meter End of Life Disposal Environmental Information The excel V system must be disposed of according to local laws and hospital practices This product is considered electronic equipment and must no...

Страница 81: ...ent 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 Las...

Страница 82: ...cular Hazard Distance NOHD The distance along the axis of the unobstructed beam beyond which exposure during normal operation is not expected to exceed the appropriate MPE This distance is measured fr...

Страница 83: ...and 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 WARNING Never s...

Страница 84: ...d in its proper use CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure WARNING Except during actual...

Страница 85: ...is grounded through the grounding conductor in the power cord Grounding is essential for safe operation WARNING Do not use this system in the presence of flammable materials solutions or gases or in...

Страница 86: ...he American National Standard for the Safe Use of Lasers in Health Care Facilities or an equivalent European Union standard The practitioner should also keep current with all relevant medical literatu...

Страница 87: ...activate the treatment beam while pointing the handpiece into free space WARNING Do not leave the system in READY mode when not in use Always place the system in STANDBY mode or turn off the system a...

Страница 88: ...positioned at the area to be treated CAUTION Before placing the system in READY mode confirm that the laser aperture on the handpiece is safely positioned to prevent unintended treatment exposure NOTE...

Страница 89: ...he 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 sy...

Страница 90: ...to indicate the delivery of 100 pulse increments 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 inte...

Страница 91: ...room staff should be familiar with the location and meaning of these labels Coolant reservoir label Distilled Water Only Regulatory compliance labels Refer to the following page for label illustratio...

Страница 92: ...on the particular procedure performed this product and the use thereof may be covered by one or more of the following U S and corresponding foreign patents and patent applications 7 465 307 7 326 199...

Страница 93: ...Warning of laser radiation from adjacent aperture Laser Radiation Warning Location of Laser Aperture Label on CoolView Handpiece Location of Laser Aperture Label on Genesis V Handpiece Warning of las...

Страница 94: ...Laser Aperture Label on Dermastat Handpiece Warning of laser radiation from adjacent aperture Laser Radiation Warning Located on CoolView and Genesis V handpiece connectors Located on Dermastat fiber...

Страница 95: ...of the excel V 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 V Guidance and Manufacturer s Declarat...

Страница 96: ...typical commercial or hospital environment Surge IEC 61000 4 5 1kV differential mode 2kV common mode 0 5 1kV differential mode 0 5 1 2kV common mode Mains power quality should be that of a typical co...

Страница 97: ...iance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 Proximity field from RF wireless communications equ...

Страница 98: ...ion distance m according to frequency 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...

Страница 99: ...iomas port wine stains venous anomalies telangiectasia facial or extremities leg veins and poikiloderma of Civatte Benign pigmented lesions including nevi and lentigines Benign cutaneous lesions inclu...

Страница 100: ...questionable pigmented lesions Do not treat over or close to tattoos or permanent make up Precautions Photosensitizing drugs Tetracyclines etc Be aware that you may have to adjust the treatment param...

Страница 101: ...only at the targeted treatment areas Ensure that the patient and all staff personnel in the treatment room wear appropriate protective eyewear If the patient cannot wear protective eyewear be sure to...

Страница 102: ...n this manual be carefully observed especially with respect to the wearing of protective eyewear by the patient practitioner and attending staff In addition the development of eye hand foot coordinati...

Страница 103: ...3 60 ms at 1064 nm Aim Beam 1 mW Max at 635 nm Class 4 Laser Product Per IEC 60825 1 2014 Aim Beam Class 2 INVISIBLE AND VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIA...

Страница 104: ...A 2 EXCEL V OPERATOR MANUAL D2325 REV A 2 19 THIS PAGE IS LEFT BLANK...

Страница 105: ...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 t...

Страница 106: ...uchscreen display Cutera defined Volume of audible tones and indicators Touchscreen display Cutera defined Touchscreen backlighting Touchscreen display Cutera defined System controller software versio...

Страница 107: ...r 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 cTUVus Mark Rear panel label IEC 60601 1 Operating temp...

Страница 108: ...ce 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 Rear panel label IEC 60825 1 Laser aperture Near laser...

Страница 109: ...eatment of reticular leg veins with a 1064 nm long pulsed Nd YAG laser Journal of the American Academy of Dermatology 2003 48 1 76 81 Rogachefsky A Silapunt S Goldberg D Nd YAG laser 1064 nm irradiati...

Страница 110: ...C 2 EXCEL V OPERATOR MANUAL D2325 REV A 2 19 THIS PAGE IS LEFT BLANK...

Страница 111: ...TERA 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 Sh...

Страница 112: ...D 2 EXCEL V OPERATOR MANUAL D2325 REV A 2 19 THIS PAGE IS LEFT BLANK...

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