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Spectranetics CVX-300, Руководство оператора

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7

7030-0068-26

28Jul16

Customer Service, Canada/US (719) 633-8333 / (800) 231-0978

Customer Service, 31 33 434 7050

CVX-300

® 

Excimer Laser System 

Version 26 

Operator’s Manual 

English / English

Warnings and Responsibility

IMPORTANT

Read the Operator’s Manual thoroughly before operating the Excimer Laser 
System CVX-300. Pay particular attention to the NOTES, CAUTIONS, and WARNINGS 
throughout this manual to ensure safe operating conditions at all times. 

 

Also refer to the Instructions for Use which accompanies Spectranetics fiber optic catheters. 
Indications and contraindications are included in individual instructions for use for the 
CVX-300 disposables.

WARNING

The CVX-300 is a Class III medical device which contains a Class IV 
laser that produces an invisible beam of high-energy ultraviolet 
radiation. Improper use of the CVX-300 could result in serious 
personal injury. Observe all safety precautions for use of Class IV 
laser equipment.

WARNING

The CVX-300 contains high voltages which are potentially lethal. 
To avoid electrical shock, do not open the CVX-300 cabinet. 
Internal maintenance must be performed solely by a Spectranetics 
Certified Field Service Engineer.

WARNING

Laser system is not intended to be used during a 
defibrillation event.

DANGER

Possible explosion hazard if used in the presence of flammable 
anesthetics.

Содержание CVX-300

Страница 1: ...1 7030 0068 26 28Jul16 CVX 300 CVX 300 P Excimer Laser System Operator s Manual Version 26 ...

Страница 2: ... reduced to any form including electronicmediumormachine readableform Thisdocumentationmaynotbetransmitted orpubliclyperformedbyanymeans electronicorotherwise withoutthewrittenconsentof The Spectranetics Corporation The documentation contains valuable trade secrets and proprietary information and is protected by federal copyright laws Unauthorized use of the documentation can result in civil damag...

Страница 3: ...PARTS OR ASSEMBLIES SERVICE OF THE SPECTRANETICS CVX 300 LASER SYSTEM MUST BE PERFORMED ONLY BY A SPECTRANETICS CERTIFIED FIELD SERVICE ENGINEER IN ORDER TO AVOID RISKS TO INDIVIDUALS CUSTOMERS AND OR PATIENTS SERVICE OFTHE SPECTRANETICS CVX 300 REQUIRES SPECIALTOOLS EQUIPMENT AND OR GASES SOME OFWHICH MAY NOT BE COMMERCIALLY AVAILABLE OR MAY ONLY BE AVAILABLE TO OR FROM THE SPECTRANETICS CORPORAT...

Страница 4: ...t 19 5 Footswitch IPX8 rated 19 6 Emergency Button 19 7 Footswitch Connector 19 8 Interlock Plug 19 9 Potential Equalization PE 19 10 Power Connector 19 11 Main Circuit Breaker 19 CVX 300 P Labeling 20 CVX 300 Labeling 23 CVX 300 Markings 25 Control Buttons 27 Calibrate 27 Fluence 27 Pulses Delivered 27 Rate 27 Read Energy 27 Ready 27 Reset 28 Standby 28 Keyswitch 28 TreatmentTime 28 Reset and Pul...

Страница 5: ...al English English Service 30 Standby 31 Testing 31 Warm up 31 Operational Modes 32 Setup Mode 32 Testing Mode 33 Warm up Mode 34 Standby Mode 35 Calibrate Mode 36 Standby Mode Returning from Calibrate Mode 39 Standby Mode Returning from Ready Mode 40 Ready Mode 40 Power Down 44 Fault Codes 44 Maintenance 45 Verification of Calibration 47 Troubleshooting 49 Glossary 53 ...

Страница 6: ...Spectraneticswillperformallwarrantyserviceandrepairsduringthenormalbusinesshours of 8 00 am to 5 00 pm at Customer s facility Monday through Friday excluding holidays Customer is responsible for assuring that the Laser is accessible to Certified Field Service Engineersatthescheduledtime CustomerwillpaySpectraneticsatitsstandardbillingrates for Warranty repairs requested outside of normal business ...

Страница 7: ...ontraindications are included in individual instructions for use for the CVX 300 disposables WARNING The CVX 300 is a Class III medical device which contains a Class IV laser that produces an invisible beam of high energy ultraviolet radiation Improper use of the CVX 300 could result in serious personal injury Observe all safety precautions for use of Class IV laser equipment WARNING The CVX 300 c...

Страница 8: ...he system Depress the brake bar to lock the wheels when the Excimer Laser System is positioned for use Lift up on the brake bar to release wheels CAUTION Use of buttons or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure WARNING Use only fibers and catheters approved by Spectranetics in the CVX 300 system The Spectranetics laser ...

Страница 9: ...ntains a gas mixture that is 0 05 HCl a respiratory irritant To avoid injury onlyatrainedandcertifiedSpectraneticsFieldServiceEngineershouldhandlethelasergas CAUTION Federal Law restricts this device to the sale or on the order of a physician RESPONSIBILITY Spectranetics is not responsible for injury or damage resulting from improper use of the CVX 300 equipment If there is any doubt concerning th...

Страница 10: ...sions Approximate Power Requirements 200 230V Single Phase 50 60 Hz 16 Amp Environmental Specifications Operating temperature 12 C to 30 C 54 F to 86 F Storage temperature 0 C to 60 C 32 F to 140 F Operating humidity 5 to 95 relative humidity non condensing Storage humidity 5 to 95 relative humidity non condensing System footswitch is IPX8 rated Accessories power cord footswitch interlock plug saf...

Страница 11: ...wear and protective gloves Protective eyewear of 5 or greater at a 308 nanometer nm wave length must be worn when operating the laser system The laser safety glasses must state the OD rating and wavelength on the lens or on the side shields Spectranetics offers safety glasses that may be purchased by calling Customer Service Sources of information about eye protection include Rockwell Laser Instit...

Страница 12: ... optic device refer to the CVX 300 Excimer Laser System Operating Instructions and precautions in this manual During these short calibration periods the energy output from the laser is not contained andtheoperatorshouldbeawareoftheNOHDfromthetipofthefiber A2 5mmfiberoptic device emits the highest amount of energy during calibration The Fiber NOHD was calculated with the system in the Normal Operat...

Страница 13: ...to or stacked with other equipment Should use adjacent to other equipment become necessary the CVX 300 should be observed to verify normal operation in that configuration Table 201 EN 60601 1 2 Guidance and Manufacturer s Declaration Electromagnetic Emissions The CVX 300 is intended for use in the electromagnetic environment specified below The customer or the user of the CVX 300 should assure tha...

Страница 14: ...upply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines 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 IEC 61000 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 s...

Страница 15: ...itter manufacturer and d is the recommended separation distance in meters m Field strengths 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 gu...

Страница 16: ...cording to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 0 10 3 7 3 7 7 4 100 12 12 12 Fortransmittersratedatamaximumoutputpowernotlistedabove therecommended separation distance d...

Страница 17: ...e stowed when not in use This section will describe how these features are used Stowable Control Panel When the laser system is not in use the control panel may be folded flat To raise the control panel lift up on the handle When the control panel is raised it may be rotated 90 left or right for easy access NOTICE Thecontrolpanelmayonlybestowedwhenthepanelisrotatedtofacethefrontoftheunit Do not at...

Страница 18: ...led up into position to facilitate system calibration Return the Energy Detector to the storage position by pushing it back into the unit and closing the protective cover NOTICE At no time should the energy detector or its mounting pole be used in an attempt to move the CVX 300 As with all CVX 300 units it is necessary to keep the area around the Catheter Connector Energy Detector and Control Pane...

Страница 19: ...n 26 Operator s Manual English English CVX 300 P Components 1 Control Panel 2 Energy Detector 3 Catheter Connector 4 Front Storage Compartment 5 Footswitch IPX8 rated 6 Emergency Button 7 Footswitch Connector 8 Interlock Plug 9 Potential Equalization PE Optional PE cable provided based on destination country 10 Power Connector 11 Main Circuit Breaker ...

Страница 20: ...stomer Service Canada US 719 633 8333 800 231 0978 Customer Service Europe 31 33 434 7050 CVX 300 Excimer Laser System Version 26 Operator s Manual English English CVX 300 P Labeling Follow Instructions for Use 1 2 3 4 5 6 21 23 ...

Страница 21: ...rvice Canada US 719 633 8333 800 231 0978 Customer Service Europe 31 33 434 7050 CVX 300 Excimer Laser System Version 26 Operator s Manual English English 7 8 9 10 11 Laser Radiation Robert A Golobic Memorial Label Spectranetics Founder ...

Страница 22: ... US 719 633 8333 800 231 0978 Customer Service Europe 31 33 434 7050 CVX 300 Excimer Laser System Version 26 Operator s Manual English English 12 13 14 15 16 17 19 20 18 Label on Remanufactured CVX 300 Only Non Ionizing Radiation Emergency Stop WEEE ...

Страница 23: ...19 633 8333 800 231 0978 Customer Service Europe 31 33 434 7050 CVX 300 Excimer Laser System Version 26 Operator s Manual English English CVX 300 Labeling 2 3 4 5 9 WEEE 1 6 7 8 Robert A Golobic Memorial Label Spectranetics Founder Operating Instructions ...

Страница 24: ...stomer Service Canada US 719 633 8333 800 231 0978 Customer Service Europe 31 33 434 7050 CVX 300 Excimer Laser System Version 26 Operator s Manual English English Laser Radiation Emergency Stop 17 19 16 15 10 11 12 13 20 14 18 ...

Страница 25: ...xcimer Laser System Version 26 Operator s Manual English English CVX 300 Markings Outside Equipotentiality Footswitch Connector Main Circuit Breaker Laser Radiation Warning Danger Caution Follow Operating Instructions WEEE Waste from Electrical and Electronic Equipment Type CF Emergency Stop FOOTSWITCH MAINS 16A US CANADA EU ...

Страница 26: ...8333 800 231 0978 Customer Service Europe 31 33 434 7050 CVX 300 Excimer Laser System Version 26 Operator s Manual English English Follow Instructions for Use Non Ionizing Radiation WorldWideWeb Address UDI Label Inside Protective Earth ground DangerousVoltage ...

Страница 27: ...s the fluence value accordingly Pulses Delivered Depressing the Pulses Delivered button enables the total number of pulses during a procedure to be visible in the display window Rate TheRatebuttonadjuststhepulserepetitionrateoftheExcimerLaserSystem Therate is increased or decreased by depressing the appropriate Rate button The repetition rate is visible in the display window and the Pulses Second ...

Страница 28: ...e until it ascends and turn the keyswitch to the OFF position and then to the ON position Refer to the Reset and Standby and Warning below to bypass the CVX 300 Excimer Laser warm up Treatment Time Depressing the Treatment Time button enables the total lasing time of the procedure to be visible in the display window Reset and Pulses Delivered The Reset and Pulses Delivered buttons are depressed si...

Страница 29: ...mode Tobegincalibration aim the fiber tip at the calibration detector head and depress the footswitch The system reads and displays the fiber output energy after each laser pulse Calibrate Button The Calibrate button illuminates indicating the Excimer Laser System is operating in Calibrate mode Calibrate Light The Calibrate advisory light indicates the Excimer Laser System needs to be calibrated C...

Страница 30: ...nitor has disabled the laser beam An audible tone will be heard whenever the Power Error lamp is illuminated During normal operation this light may flicker as the laser energy varies within the acceptable range The CVX 300 will continue to lase as the unit is working to correct the condition The shutter will remain closed while Power Error is illuminated preventing energy delivery through the fibe...

Страница 31: ...button illuminates indicating the Excimer Laser System is operating in Standby mode The green status light on top of the control panel also illuminates when the system is in Standby mode Testing The Testing status light indicates the Excimer Laser System is checking the internal operation of the control circuitry Warm up The Warm up status light indicates the Excimer Laser System is operating in W...

Страница 32: ...nto the power receptacle Insert the other end of the power cord into a wall receptacle with the proper output voltage Note Anytime an extension cord is used to power the CVX 300 on a temporary basis it must be a minimum 12 AWG cord of type SJO SJT SJOOW or equivalent The power cordshouldberoutedtoavoidalltrippinghazardsanddamagefromotherequipment Any temporary extension cord must be disconnected a...

Страница 33: ...us buttons and advisory lights except standby and green status light on top of the control panel are illuminated simultaneously for approximately 5 7 seconds Six number eights 8 are visible in the display window Figure 1 Figure 1 LampTest 3 At the end of the lamp test Standby and Testing are illuminated Figure 2 The software version number will displayed following the lamp test During the test cyc...

Страница 34: ...must be corrected by Spectranetics service personnel before the system can be restored to an operational mode Refer to the Fault Codes section The operator may turn the laser to the OFF position for 5 seconds and then to the ON position to attempt restarting the system 5 Whentheinternaltestiscomplete theExcimerLaserSystementersWarm upmode A 5 minute countdown timer indicates warm up time remaining...

Страница 35: ...play when the fiber optic catheter is inserted Some devices may have different Calibration settings than are displayed always verify these settings with the recommended settings in the device s Instructions for Use documentation The remaining warm up time is normally visible in the display window Briefly depressing a Fluence or Rate increment or decrement button enables the fluence value and pulse...

Страница 36: ...Figure 4 Figure 4 Standby 3 When the Excimer Laser System is in Standby mode for the first time after being powered up or a fiber optic catheter is changed depressing the Calibrate button causes the system to enter Calibrate mode Calibrate Mode 1 Insert the coupler on the proximal end of the fiber optic catheter into the center of the connector on the CVX 300 2 The appropriate calibration values w...

Страница 37: ...e five minute warm up period and enter the Standby mode 4 Clean the face of the energy detector with an alcohol prep before and after each use 5 Depress the Calibrate button to enter Calibrate mode 6 The yellow Ready status on the top of the control panel Aim Fiber Energy Millijoules Calibrate Calibrate button and Ready button lights are illuminated The display window shows 00 0 on the three right...

Страница 38: ...isplay window shows in the three rightmost digits the energy out of the fiber optic catheter As the CVX 300 calibrates the energy out of the distal tip of the fiber optic catheter increases or decreases until the energy corresponding to the fluence setting for that fiber optic catheter is reached When the calibration is completed the CVX 300 stops lasing displays the final calibration energy value...

Страница 39: ...pear in the display Refer to theTroubleshooting section of this manual 13 If a second calibration attempt is unsuccessful call Spectranetics Customer Service for assistance 14 The CVX 300 returns to the Standby mode if calibration is not completed within one minute 15 If the Fault advisory light illuminates and a numerical fault code is displayed refer to the Troubleshooting section of this manual...

Страница 40: ...tatus light on the top of the control panel are illuminated 3 The fluence value and pulse repetition rate appear in the display window 4 The Cal OK advisory light remains illuminated Figure 8 Ready Mode 1 Ready mode is entered from Standby mode by depressing the Ready button Figure 9 2 The Ready button Cal OK light and yellow status light on the top of the control panel are illuminated 3 The fluen...

Страница 41: ...re 9 Ready 4 The Excimer Laser System is now ready to use in a procedure 5 DepressingthefootswitchcausestheredLasinglightandredstatuslightonthetopof the control panel to illuminate Figure 10 6 TheExcimerLaserSystembeginstolaseatthespecifiedpulserepetitionrate Releasing the footswitch stops lasing the red Lasing light and red status light on the top of the control panel go out Figure 10 Lasing ...

Страница 42: ...or light illuminates and the total treatment time is visible in the display window Figure 11 8 To reset the treatment time counter depress the Reset and Treatment Time buttons simultaneously 9 While the Excimer Laser System is lasing the number of pulses delivered during a procedure is accumulated To retrieve the total number of pulses delivered stop lasing and depress the Pulses Delivered button ...

Страница 43: ...mer Laser System Version 26 Operator s Manual English English Figure 12 PulsesDelivered 11 Pressing the Read Energy button causes the fiber output energy to be visible in the display window To read the energy coming from the fiber aim the fiber at the calibration detector and depress the footswitch Figure 13 Figure 13 ReadEnergy ...

Страница 44: ... power cord from the power source 4 Disconnect and store the Footswitch in the front storage compartment 5 Close the catheter connector door 6 Clean detector face with alcohol prep 7 When not in use the laser system should be protected from unqualified use by removing the key 8 Cover the laser system Fault Codes When a fault is detected by the system a code number is displayed in the middle of the...

Страница 45: ...tive maintenance be performed on the unit every three to six months Preventive Maintenance is required annually at a minimum Internal maintenance must be solely performed by a Spectranetics Certified Field Service Engineer Internally the CVX 300 contains no user serviceable parts Product safety tests in the form of current leakage and ground testing should be performed by a Biomedical Engineer acc...

Страница 46: ...ed immediately upon completion of the task for which it was installed WARNING The CVX 300 contains a Class IV laser that produces an invisible beam Potentiallylethalhighvoltagesarepresentinsidethesystem The gas mixture utilized inside the laser contains 0 05 HCl a respiratory irritant WARNING Failure to service the equipment properly may result in personal injuryordeath Serviceshouldonlybecomplete...

Страница 47: ...ator has been trained by Spectranetics on the proper use safety and operation of the CVX 300 This procedure also requires that the operator has been trained on the use safety and operation of the NIST calibrated Joule Meter Energy Monitor Verification Procedure 1 Connect the power cord to the rear panel of the laser system Ensure power cord is fully seated into the power receptacle Insert the othe...

Страница 48: ...14 Compare the recorded energy value in step 10 with the recorded energy value in step 13 15 The difference in the two recorded energy values should be less than 20 CFR 21 1040 11 Section 1 when using the following equation energy value in step 10 energy value in step 13 energy value in step 13 16 NotifytheSpectraneticsCustomerServiceDepartmentimmediatelyifthedifferencein the recorded energy value...

Страница 49: ...wise direction The CVX 300 will not enter the Calibrate mode Allow the CVX 300 time to complete the warm up mode Insert a fiber optic catheter into the coupler Plug in the footswitch Set the fluence and pulse repetition rate Alarm sounds when the ready button is depressed Calibrate the system The CVX 300 does not complete calibration Depress and hold the footswitch down until lasing stops and the ...

Страница 50: ...ly Call Spectranetics Customer Service for assistance A fault occurs during Warm up or Calibration the fault indicator is illuminated and a fault code number is shown in the middle of the display window Refer to the Fault Code Table at the end of this section The laser gives an odor of HCl gas like bleach Place the laser in a well ventilated yet isolated room Call Spectranetics Customer Service to...

Страница 51: ...m opening Fiber Power Monitor test error Clean the Energy Detector Surface with an alcohol prep Clean the fiber optic catheter tip and re calibrate at the recommended settings 45 25 for ELCA devices 60 40 for SLS devices Ensure the device is pointed at the center of the energy detector one to two inches away If calibration is unsuccessful attempt to re calibrate the device at a lower fluence setti...

Страница 52: ...ypass the warm up period by pressing the RESET and STANDBY buttons simultaneously in order to bypass the warm up period the system must not be OFF for longer than 30 seconds Attempt to calibrate with the Reference Catheter Ifsuccessful attempttocalibratethefiberopticcatheterto be used in the patient Proceed if successful Report the incident to Spectranetics after the case is complete If the Power ...

Страница 53: ...r laser A pulsed gas laser which lases when two atoms form a temporary excited molecule Excimer radiation Electromagnetic radiation emitted from the CVX 300 which includes all reflected radiation and any other form of energy resulting from the primary beam Excitation The addition of energy to a particle or system of particles to produce an excited state FDA The Food and Drug Administration Fiber o...

Страница 54: ...frequency ELF sometimes referred to as EMF or ELF EMF Neon Ne A rare inert gas occurring in the atmosphere It is colorless but glows reddish orange in an electrical discharge Proximal Nearest to the point of attachment or origin Pulsed laser A laser which delivers energy in short bursts Repetition rate The rate at which the laser delivers pulses usually expressed as pulses per second Type CF Class...

Страница 55: ...26 28Jul16 Customer Service Canada US 719 633 8333 800 231 0978 Customer Service Europe 31 33 434 7050 CVX 300 Excimer Laser System Version 26 Operator s Manual English English This page is intentionally left blank ...

Страница 56: ...l16 www spectranetics com Spectranetics Corporation 9965 Federal Drive Colorado Springs CO 80921 USA Tel 1 800 231 0978 Fax 719 447 2022 2016 Spectranetics Corporation All Rights Reserved Approved for External Distribution ...

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