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EXCEL V OPERATOR MANUAL

D1025, REV H, 10/17

Genesis V Treatment

Screen

When the Genesis V handpiece is connected to the console fiber receptacle, the Genesis V Treatment
Screen displays after the successful completion of the self-test routine at system start-up.

From the Genesis V Treatment

Screen, you can:

• select the fluence and repetition rate

(refer to the

User-selectable Parameters

topic)

• store and recall frequently used treatment parameters

(refer to the

Memory Storage

topic)

• monitor the measured temperature of the target tissue

(refer to the

Displays and Indicators

topic)

• select the system status

(refer to the

System Status: STANDBY and READY Modes

topic)

• view and reset the pulse counter

(refer to the

Displays and Indicators

topic)

• go to the Information & Adjustment Screen

(refer to

Information & Adjustment Screen

topic)

Genesis V Treatment Screen

Содержание Excel V

Страница 1: ...I Operator Manual ...

Страница 2: ...ations 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 October 2017 Cutera Inc Published in USA D1025 Revision H Cutera Inc 3240 Bayshore B...

Страница 3: ...ote Interlock Plug 5 Connecting the Handpiece 7 Connecting the Handpiece Dummy Plug 8 Connecting the Main Power Cable 9 System Basics 10 Turning On the System 10 Restarting the System 11 Turning Off the System 11 Emergency Off 11 Disconnecting the Handpiece Fiber Connector 12 Disconnecting the Handpiece Connector or Dummy Plug 12 Disconnecting the System 13 Moving the System 13 General System Func...

Страница 4: ...2 Adjusting the Temperature of the Sapphire Cooling Window 43 Genesis V Handpiece Instructions 44 Selecting the Fluence 44 Selecting the Repetition Rate 45 MAINTENANCE 47 Troubleshooting Guide 47 Error Code Guide 50 Annual System Maintenance 51 System Repair 51 Routine User Maintenance 51 Cleaning the External Surfaces of the System Console 51 Cleaning the System Touchscreen Display 51 Inspecting ...

Страница 5: ...rements 63 Maximum Allowable Temperature of Accessible Parts 63 Classifications 64 Eye Safety 64 Calibration Procedure 65 Equipment Required 65 Calibration Instructions 66 End of Life Disposal Environmental Information 66 Warranty Information 66 SAFETY AND REGULATORY 67 Introduction 67 Optical Hazard 67 Additional Ocular Protection 69 Additional Safety Considerations 70 Protecting Non Target Tissu...

Страница 6: ...nce Labels 77 Electromagnetic Compatibility 79 CLINICAL APPLICATIONS 83 General Indications for Use 83 532 nm KTP Indications 83 1064 nm Nd YAG Indications 84 Contraindications for Use 84 Warnings 84 Precautions 84 Expected Transient Events and Possible Adverse Effects 85 Treatment Precautions 85 Treatment Information 86 Patient Information 86 APPENDIX A LASER WARNING SIGN APPENDIX B SYMBOLS APPEN...

Страница 7: ...nign 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 regarding your system contact your local Cutera representative WARNING Any laser device can generate highly concentrated light which may cause injury if improperly used To protect patients and operati...

Страница 8: ...s This makes the Nd YAG 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 system is shipped directly from the factory to your site Your local Cutera representative will initially uncrate inspect set up and install the system to ensure that it is working properly before use ...

Страница 9: ...re available for use with the Excel V CoolView and Genesis V The CoolView handpiece features integrated motorized zoom and epidermal cooling The motorized zoom feature enables you to adjust the laser spot size from 2 to 12 mm The epidermal cooling feature allows you to adjust the temperature of the sapphire cooling window to increase safety and efficacy The Genesis V handpiece features an integrat...

Страница 10: ...4 EXCEL V OPERATOR MANUAL D1025 REV H 10 17 Boom CoolView Handpiece Genesis V Handpiece Footswitch Remote interlock plug System console dual handpiece model shown Holsters ...

Страница 11: ...terlock 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 whether or not an external door switch is used When using an external door switch the system completely shuts down if the treatment room door is opened or the remote interlock plug is removed To resume tr...

Страница 12: ...6 EXCEL V OPERATOR MANUAL D1025 REV H 10 17 Remote Interlock Plug Footswitch ...

Страница 13: ...rotective 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 connector lines up with the alignment guide above the fiber receptacle 5 Lock the fiber connector in place by gently pushing the fiber connector into the receptacle and then turning clockwise toward the icon NOTE It is import...

Страница 14: ...iece receptacle 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 two audible clicks indicating that both locking tabs are engaged NOTE It is important to listen for two clicks when installing the dummy plug The dummy plug is properly connected only when both ...

Страница 15: ...sition 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 appropriate wall socket and turn the main electrical service ON Ensure that the main power circuit breaker is in the up ON position Power cable wrap Main power circuit breaker Power cable receptacle ...

Страница 16: ...displays the start up screen and the system begins a self test routine After approximately 30 seconds the system emits an audible tone and the touchscreen displays the CoolView Select Screen or the Genesis V Treatment Screen depending on which handpiece is connected to the system console If any fault conditions advisory messages or error codes appear in the pop up display during self test refer to...

Страница 17: ...t 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 the system NOTE When the main power cable is connected to the electrical source some internal circuits remain energized To de energize all the internal circuits turn off the main power circuit breake...

Страница 18: ...e 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 dummy plug from the handpiece receptacle 1 Press down on the front locking tab to release the handpiece connector or dummy plug 2 Press down and hold the rear locking tab and gently pull up on the h...

Страница 19: ...he 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 described above when moving the system any distance other than within one room The handpiece s may be dislodged from the holster s when the system is moved over thresholds or uneven surfaces Damage wi...

Страница 20: ...14 EXCEL V OPERATOR MANUAL D1025 REV H 10 17 5 Lock each of the system console wheels by engaging each wheel lock Wheel locks ...

Страница 21: ...e 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 select the patient s skin type and the intended application and the recommended range of settings displays on the CoolView Treatment Screen You then select parameters from the recommended range of set...

Страница 22: ...at 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 operate in expert mode Refer to Selecting Treatment Parameters in Navigation Mode or Selecting Treatment Parameters in Expert Mode later in this chapter for detailed information on selecting treatmen...

Страница 23: ...button 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 Select Screen the CoolView Treatment Screen displays with the Skin Type menu open CoolView Treatment Screen in Expert Mode ...

Страница 24: ... 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 sapphire cooling window refer to the User selectable Parameters topic store and recall frequently used treatment parameters refer to the Memory Storage topic select the system status refer to the System...

Страница 25: ...ce and repetition rate refer to the User selectable Parameters topic store and recall frequently used treatment parameters refer to the Memory Storage topic monitor the measured temperature of the target tissue refer to the Displays and Indicators topic select the system status refer to the System Status STANDBY and READY Modes topic view and reset the pulse counter refer to the Displays and Indic...

Страница 26: ...ernal 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 the safety shutter is open the treatment and aiming beams are available the laser status button is green Location of Laser Status Button CoolView Treatment Screen shown Laser status button STANDBY mo...

Страница 27: ...m 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 STANDBY mode prevents accidental treatment beam exposure if the footswitch is inadvertently depressed WARNING Verify that all persons in the treatment room are wearing the appropriate treatment beam safety ...

Страница 28: ... 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 memory will be overwritten with the new parameters To recall previously stored treatment parameters 1 Press the memory button to display the memory pop up window 2 Press and release the number next to ...

Страница 29: ...nsity 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 the Treatment Screen Information Adjustment Screen Genesis V screen shown Controls for adjusting volume of laser emission indicator and other audible tones and voice prompts Controls for adjusting tou...

Страница 30: ...targeted treatment site 3 Press the aiming beam button to display the aiming beam pop up window 4 Select the desired aiming beam setting from the aiming beam pop up window NOTE The aiming beam is wavelength specific allowing you to set different aiming beam characteristics for the 532 nm and 1064 nm wavelengths The aiming beam settings that you select for the 1064 nm wavelength will apply to both ...

Страница 31: ...tones 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 the Treatment Screen to go to the Information Adjustment Screen NOTE If the laser output is greater than 120 of the requested energy the regular exposure tone is replaced by a higher pitched tone...

Страница 32: ...red since the counter was last reset and a reset button allows you to reset the counter A temperature display shows the actual temperature of the CoolView handpiece sapphire cooling window On the CoolView handpiece A laser emission indicator illuminates when the system is set to READY and the footswitch is pressed CoolView Treatment Screen Pulse counter reset button Pulse counter reset button Puls...

Страница 33: ...luminates when the system is set to READY and the footswitch is pressed An integrated temperature sensor and six LED temperature indicators enable thermal monitoring of the target tissue The sensor measures 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 ...

Страница 34: ...orking 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 from the Information Adjustment Screen Genesis V Handpiece LED temperature indicators Laser emission indicator 3 7 cm Temperature sensor not visible Aiming beam and treatment beam not visible optimal working distance Wor...

Страница 35: ...section 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 Navigation Mode section below For instructions on operating in expert mode skip to the Selecting Treatment Parameters in Expert Mode section that follows NOTE Fluence pulse duration and spot size setti...

Страница 36: ...operate 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 Navigation Buttons on CoolView Select Screen Location of Navigation Button on CoolView Treatment Screen ...

Страница 37: ...CoolView 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 Type Menu Open CoolView Treatment Screen with Skin Type and Treatment Category Menus Open ...

Страница 38: ...o 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 range of settings highlighted in green CoolView Treatment Screen with Skin Type Treatment Category and Treatment Subcategory Menus Open Sample CoolView Treatment Screen in Navigation Mode ...

Страница 39: ...red 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 the bottom left corner of the CoolView Treatment Screen The third pop up message indicates that the desired application is unsupported for both wavelengths Clear the message by pressing the button and...

Страница 40: ...t 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 select new parameters in navigation mode as described in the previous section Location of Navigation and Wavelength Buttons on CoolView Treatment Screen Navigation button Wavelength buttons ...

Страница 41: ...tton 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 mode exit navigation mode as described on the previous page Location of Expert Mode Button on CoolView Select Screen CoolView Treatment Screen in Expert Mode ...

Страница 42: ...lect 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 at the bottom left corner of the screen Location of Wavelength Selection Buttons on CoolView Select Screen Location of Wavelength Selection Buttons on CoolView Treatment Screen ...

Страница 43: ...ot size 1 Press the and buttons next to the spot size display on the CoolView Treatment Screen to select the approximate laser spot size 2 Press the and buttons on the CoolView handpiece to fine tune the laser spot size Location of Spot Size Controls and Display on CoolView Treatment Screen Location of Spot Size Adjustment Buttons on CoolView Handpiece Spot size adjustment buttons ...

Страница 44: ...tion settings may make available a wider range of spot size settings CAUTION In navigation mode if you select a spot size that is not within the recommended range of settings for the specified skin type and application the icon appears next to the spot size display to alert you that the spot size is not recommended You are still able to operate the laser with the selected spot size but you should ...

Страница 45: ...ce 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 the maximum fluence setting for the current treatment parameters the button is disabled Changing the pulse duration and or spot size settings may make available a wider range of fluence settings Loca...

Страница 46: ...ended 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 able to operate the laser with the setting but you should proceed with caution CoolView Treatment Screen in Navigation Mode with Fluence Setting Outside Recommended Range ...

Страница 47: ...essing 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 pulse duration setting for the current treatment parameters the button is disabled Changing the fluence and or spot size settings may make available a wider range of pulse duration settings Location o...

Страница 48: ... measured 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 the repetition rate is set to the maximum setting the button is disabled Location of Repetition Rate Controls and Display on CoolView Treatment Screen ...

Страница 49: ...lect 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 status button to toggle to READY mode the window will cool to the selected temperature NOTE The selected temperature displays in the temperature button The actual temperature of the sapphire cooling ...

Страница 50: ...pressing the and buttons 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 treatment parameters the button is disabled when you reach the maximum fluence setting for the current treatment parameters the button is disabled Location of Fluence Controls and Display ...

Страница 51: ...0 0 Hz single shot to 10 0 Hz and is adjustable in 0 1 Hz increments 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 the repetition rate is set to the maximum setting the button is disabled Location of Repetition Rate Controls and Display on Genesis V Treatment Screen ...

Страница 52: ...46 EXCEL V OPERATOR MANUAL D1025 REV H 10 17 THIS PAGE IS LEFT BLANK ...

Страница 53: ...al 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 electrical service outlet 3 Remote interlock verify that the remote interlock plug is inserted into the interlock receptacle If the remote interlock plug is used in conjunction with an external door sw...

Страница 54: ...he 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 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 ...

Страница 55: ...irement 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 building power main electrical service has been inter rupted Suggestion Verify and or turn on the building power Probable Cause The system main power circuit breaker has tripped Suggestion Place the s...

Страница 56: ...ers 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 cleared by pressing the button Probable Cause The footswitch is not properly connected to the console Suggestion Ensure that the footswitch is properly connected to the con sole NOTE Press the button...

Страница 57: ...loth 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 Weekly or as needed Clean the system touchscreen display Weekly or as needed Inspect and clean the handpiece During treatment as needed and between patient use Inspect and clean the heat exchanger i...

Страница 58: ...e handpiece the following optical surfaces need to be maintained CoolView handpiece recessed lens and patient contact and proximal surfaces of cooling window Genesis V handpiece recessed lenses Proximal surface of cooling window Location of CoolView Handpiece Optical Surfaces Patient contact surface of cooling window Recessed lens Location of Genesis V Handpiece Optical Surfaces Recessed lenses ...

Страница 59: ...eaning the handpiece ensure that the system is either turned off or in STANDBY mode Always wear proper protective eyewear while the system is on Severe eye damage can occur in the event of unintended laser emission CAUTION Do not allow liquid or cleaning solution to enter the handpiece housing as damage may occur CAUTION Do not attempt to sterilize the handpiece Damage will occur if the handpiece ...

Страница 60: ...CAUTION Inspecting and cleaning the handpiece lens es is the responsibility of the practitioner If the lens es is are not properly maintained debris can build up on the surface of the lens es leading to permanent damage to the lens es and ultimately permanent damage to the handpiece optical system If debris cannot be removed from the lens es the handpiece must be replaced CAUTION Do not use germic...

Страница 61: ... lens es 3 Gently wipe the surface of the lens es Refer to the pictures 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 are not acceptable and a handpiece with these types of defects must be replaced Location of CoolView Handpiece Lens Recessed lens L...

Страница 62: ...Inc 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 with a cloth dampened with isopropyl alcohol or with a germicidal disposable wipe WARNING The system must be turned off or in STANDBY mode prior to inspecting the cooling window Do not inspect the wi...

Страница 63: ...urface 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 cooling window If necessary clean the window again CAUTION The cooling window must be clean before treating a patient Chips pits cracks or burned spots on the window are not acceptable and a handpie...

Страница 64: ...perature 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 console for dust or lint accumulation 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 to remove an...

Страница 65: ... 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 5 Allow the system to run for 5 to 10 seconds 6 Turn the keyswitch to the OFF position 7 Top off the reservoir carefully 8 Repeat steps 4 thru 7 until the reservoir is full 9 Replace the fill cap CAUTION Permanent damage to internal components will oc...

Страница 66: ...hase 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 ...

Страница 67: ...for 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 standard EN 60601 2 22 the 220 VAC configured Excel V system must be either permanently connected to a 16A 220 VAC 50 Hz supply mains in accordance with national wiring regulations or connected by mean...

Страница 68: ... Rate 0 0 Hz single shot to 4 0 Hz CoolView 0 Hz single shot to 2 0 Hz Genesis V 0 Hz single shot to 10 0 Hz Treatment Spot 2 to 12 mm circular spot CoolView 2 to 12 mm circular spot Genesis V 8 mm circular spot Delivery System CoolView handpiece with user detachable umbilical CoolView and Genesis V handpieces with user detachable umbilical Working Distance n a CoolView n a Genesis V 3 to 4 cm Epi...

Страница 69: ... 50 60 Hz Environmental Requirements Temperature Operating 5º C to 30º C Non operating 10º C to 50º C coolant 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 Operating 60 to 110 kPa Maximum Allowable Temperature of Accessible Parts Parts User Patient Can Touch Material Duration Limits Enclosure P...

Страница 70: ...t 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 Optical Density for 5 89 at 532 nm Protective Eyewear 5 81 at 1064 nm Maximum Permissible Exposure 1 35E 4 W cm2 at 532 nm 4 02E 4 W cm2 at 1064 nm ...

Страница 71: ...D 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 SH sensor The meter used must have received a NIST traceable calibration within the past 12 months in the US or a calibration conforming to the applicable standard internationally WARNING Failure t...

Страница 72: ...nal 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 not be disposed of as unsorted municipal waste and must be collected separately Please contact the manufacturer or other authorized disposal company to decommission your equipment Proper disposal of e...

Страница 73: ...arameters 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 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 Haz...

Страница 74: ...minal Ocular 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 from the laser aperture Nominal Hazard Zone NHZ The space within which the exposure level during normal operation exceeds the applicable MPE The outer limit of the NHZ is the NOHD For specific va...

Страница 75: ...stand 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 substitute non laser prescription eyewear for the appropriate laser safety eyewear as severe damage could occur WARNING Use caution when performing procedures around the eyes Severe and irreversible ...

Страница 76: ...ned 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 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 h...

Страница 77: ...em 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 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 cotto...

Страница 78: ...the 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 literature WARNING Do not allow untrained or unqualified personnel to use the system at any time CAUTION US federal law restricts the sale of this device to or by the order of a licensed practitioner license...

Страница 79: ...er 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 and remove the key when not performing treatments WARNING Do not leave the system unattended with the key in place CAUTION Prior to each use of the system inspect all protective eyewear cables and th...

Страница 80: ... 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 or light energy 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 th...

Страница 81: ...on The shutter is opened only when the system is in the READY mode Audible Emission Indicator Each laser pulse delivered is accompanied by an audible tone In addition a distinctive water drop sound is emitted each time the pulse counter reaches a count that ends in 00 in order to indicate the delivery of 100 pulse increments Manual Reset If the system shuts down during operation due to electrical ...

Страница 82: ...reatment 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 illustrations and Appendix B for symbol descriptions Non interlock housing label 01 00816722022103 11 YYMMDD 21 EVyyyyy Unique Device Identifier UDI Label 2D barcode Global Trade Identification Number GT...

Страница 83: ...ystem ON Momentary Start Non interlock Housing Label Located on top of console next to red button Located next to keyswitch Located next to keyswitch Located next to keyswitch Located on rear of system console Tilting Hazard Label Located on sides of system console Warning of tilting hazard Do not push console over obstacle 10 mm in height Doing so may cause user injury ...

Страница 84: ...f laser radiation from adjacent aperture Laser Radiation Warning Location of Laser Aperture Label on CoolView Handpiece OR Location of Laser Aperture Label on Genesis V Handpiece Warning of laser radiation from adjacent aperture Laser Radiation Warning OR ...

Страница 85: ...on 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 Declaration Electromagnetic Emissions The Excel V is intended for use in the electromagnetic environment specified below The customer or the user of the Excel V should ensure that it is used in such an env...

Страница 86: ...ential mode 2kV common mode 0 5 1kV differential 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 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 ...

Страница 87: ...hs from fixed RF transmitters as determined by an electromagnetic 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 and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absor...

Страница 88: ...tion 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 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 th...

Страница 89: ...dermatology 532 nm KTP Indications The 532 nm wavelength is indicated for the coagulation and hemostasis of benign vascular and cutaneous lesions in dermatology including but not limited to the following general categories Benign vascular lesions including angiomas hemangiomas port wine stains venous anomalies telangiectasia facial or extremities leg veins and poikiloderma of Civatte Benign pigmen...

Страница 90: ... not limited to periocular and perioral wrinkles Contraindications for Use Contraindications for use Pregnant patients Patients undergoing treatment for skin cancer Warnings Do not treat over dysplastic nevi or questionable pigmented lesions Do not treat over or close to tattoos or permanent make up Hair removal by lasers can cause increased hair growth in some individuals Based upon currently ava...

Страница 91: ...information provided in the Safety and Regulatory section the following safety precautions are recommended Guard against accidental exposure to laser energy Instruct all staff members to carefully aim the treatment beam 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...

Страница 92: ...ays be directed away from the eye and only applied to the skin outside of the orbital rim WARNING It is essential that all safety precautions as recommended in 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 coordination while using the laser system s handpiec...

Страница 93: ... 1 60 ms at 1064 nm Aim Beam 1 mW Max at 650 nm Class 4 Laser Product Per IEC 60825 1 2007 Aim Beam Class 2 INVISIBLE AND VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION USE PROPER EYEWEAR WHEN OPERATING AND OR TREATING PATIENTS 3000770 rC Appendix A Laser Warning Sign Excel V Laser Warning Sign ...

Страница 94: ...A 2 EXCEL V OPERATOR MANUAL D1025 REV H 10 17 THIS PAGE IS LEFT BLANK ...

Страница 95: ...t breaker and 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 Control panel next to red button 417 5266 Standby Touchscreen display 417 5264 Ready Touchscreen display Cutera defined Aiming beam adjustment Touchscreen display Cutera defined Save recal...

Страница 96: ...Touchscreen display Cutera defined Volume of audible tones and indicators Touchscreen display Cutera defined Touchscreen backlighting Touchscreen display Cutera defined System controller software version Touchscreen display Cutera defined System handpiece software version Touchscreen display Cutera defined System display software version Touchscreen display Cutera defined Footswitch receptacle Rea...

Страница 97: ...facturer 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 temperature range Rear panel label IEC 60601 1 Consult accompanying documents Rear panel label WEEE Directive Waste of electrical and electronic equipment must not be disposed as unsorted municipal...

Страница 98: ...9 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 she practices to use or order the use of the device Rear panel label or IEC 60825 1 Laser aperture Near laser aperture on handpiece IEC 60601 1 Tilting hazard do not push console over obstacle 10 mm in height Side panels Symbol Standard Reference Description Location ...

Страница 99: ...reatment 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 irradiation for lower extremity telangiectasias and small reticular veins efficacy as measured by vessel color and size Dermatologic Surgery 2002 28 220 3 Sarradet D Hussain M Goldberg D Millisecond 1064 nm N...

Страница 100: ...C 2 EXCEL V OPERATOR MANUAL D1025 REV H 10 17 THIS PAGE IS LEFT BLANK ...

Страница 101: ...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 Tel 81 0 3 5456 6325 Fax 81 0 3 5456 2213 Cutera Europe Cutera France 1 rue Georges Charpak Bât C 77127 LIEUSAINT Tel 33 0 1 60 62 24 40 Fax 33 0 1 60 34 31 75 ...

Страница 102: ...D 2 EXCEL V OPERATOR MANUAL D1025 REV H 10 17 THIS PAGE IS LEFT BLANK ...

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