Spectranetics CVX-300 Operator's Manual
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Spectranetics CVX-300 Operator's Manual

Excimer laser system
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CVX-300®
CVX-300®-P
Excimer Laser System
Operator's Manual
Version 26
7030-0068-26
28Jul16
1

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  • Page 1 CVX-300® CVX-300®-P Excimer Laser System Operator’s Manual Version 26 7030-0068-26 28Jul16...
  • Page 2 Operator’s Manual ® English / English © 2016 THE SPECTRANETICS CORPORATION. ALL RIGHTS RESERVED. The documentation contained herein is confidential and proprietary. This documentation may not be copied, reproduced, disclosed, transferred, or reduced to any form, including electronic medium or machine-readable form. This  d ocumentation may not be transmitted or publicly performed by any means, electronic or otherwise, without the written consent of The Spectranetics Corporation.
  • Page 3 ® English / English Preface The CVX-300 is an excimer laser system approved for use in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads. The CVX-300 produces pulsed excimer radiation which is delivered to the target site with proprietary fiber optic catheter technology, or other approved instruments or accessories, to complete the system.

  • Page 4: Table Of Contents

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Contents Warranty ..............................6 Warnings and Responsibility .........................7 Specifications ............................10 Safety Precautions ..........................11 Nominal Ocular Hazard Distance (NOHD) ..................12 EMC Precautions ............................13 Stowable Control Panel / Energy Detector ..................17 Stowable Energy Detector ........................18...
  • Page 5 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® 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...

  • Page 6: Warranty

    Operator’s Manual; or service that is required due to any damage to the Laser from outside causes. This warranty extends only to the entity that acquires the Laser from Spectranetics and will not extend to any successor of that entity.

  • Page 7: Warnings And Responsibility

    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.
  • Page 8 WARNING Use only fibers and catheters approved by Spectranetics in the CVX-300 system. The Spectranetics laser fiber optic catheters are supplied sterile. Sterility is guaranteed only if the package is unopened and undamaged.
  • Page 9 CVX-300 must be allowed to idle in Standby Mode for a minimum of one (1) hour. NOTICE The CVX-300 contains a gas mixture that is 0.05% HCl, a respiratory irritant. To avoid injury, only a trained and certified Spectranetics Field Service Engineer should handle the laser gas. CAUTION Federal Law restricts this device to the sale or on the order of a physician.

  • Page 10: Specifications

    - Storage humidity: 5 to 95% relative humidity, non-condensing System footswitch is IPX8 rated. Accessories: power cord, footswitch, interlock plug, safety glasses, and Spectranetics approved fiber optic catheters. Environment: Avoid exposing the laser system to extreme temperatures (below 32 °F or 0 °C, above 140 °F or 60 °C).

  • Page 11: Safety Precautions

    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 Institute (rli.com) and Ultra-Violet...

  • Page 12: Nominal Ocular Hazard Distance (Nohd)

    (MPE) limits. All laser energy produced by the CVX-300 Excimer Laser System, when operated in accordance with this manual, is enclosed within the CVX-300, the Spectranetics Fiber Optic Device or within the body except during the calibration of the fiber optic device (refer to the CVX-300 Excimer Laser System Operating Instructions and precautions in this manual).

  • Page 13: Emc Precautions

    EMC Precautions Special precautions are required regarding the Electromagnetic Compatibility (EMC) of the CVX-300. The CVX-300 needs to be installed and put into service according the EMC information provided in this manual. Portable and Mobile Radio Frequency (RF) communications equipment can affect any medical electrical equipment including the CVX-300.
  • Page 14 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Table 202 (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 that it is used in such an environment.
  • Page 15 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Table 204 (EN 60601‑1‑2) Guidance and manufacturer’s declaration – Electromagnetic Immunity The CVX‑300 is intended for use in the electromagnetic environment specified below. The customer or the user of the CVX‑300 should assure that it is used in such an environment.
  • Page 16 Table 206 (EN 60601‑1‑2) Recommended separation distances between portable and mobile RF communications equipment and the CVX-300 The CVX‑300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CVX‑300...

  • Page 17: Stowable Control Panel / Energy Detector

    English / English Stowable Control Panel / Energy Detector Some CVX-300 Excimer Laser Systems have a control panel and an energy detector that can be 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.

  • Page 18: Stowable Energy Detector

    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 Panel clean, dry and free of contaminants.

  • Page 19: Cvx-300-P Components

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English CVX‑300‑P Components Control Panel Energy Detector Catheter Connector Front Storage Compartment Footswitch (IPX8 rated) Emergency Button Footswitch Connector Interlock Plug Potential Equalization (PE) (Optional PE cable provided based on destination country) 10.

  • Page 20: Cvx-300-P Labeling

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English CVX‑300‑P Labeling (Follow Instructions for Use) 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978 Customer Service, Europe +31 33 434 7050...
  • Page 21 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English (Laser Radiation) (Robert A. Golobic Memorial Label – Spectranetics Founder) 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978 Customer Service, Europe +31 33 434 7050...
  • Page 22 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English (WEEE) (Label on Remanufactured CVX‑300 Only) (Emergency Stop) (Non‑Ionizing Radiation) 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978 Customer Service, Europe +31 33 434 7050...

  • Page 23: Cvx-300 Labeling

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English CVX‑300 Labeling (WEEE) (Robert A. Golobic Memorial Label – Spectranetics Founder) (Operating Instructions) 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978 Customer Service, Europe +31 33 434 7050...
  • Page 24 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English (Emergency Stop) (Laser Radiation) 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978 Customer Service, Europe +31 33 434 7050...

  • Page 25: Cvx-300 Markings

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English CVX‑300 Markings Outside: Equipotentiality FOOTSWITCH Footswitch Connector MAINS (16A) (US/CANADA/EU) Main Circuit Breaker Laser Radiation Warning, Danger, Caution Follow Operating Instructions WEEE (Waste from Electrical and Electronic Equipment)
  • Page 26 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Follow Instructions for Use Non-Ionizing Radiation World Wide Web Address UDI Label Inside: Protective Earth (ground) Dangerous Voltage 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978...

  • Page 27: Control Buttons

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Control Buttons Calibrate: Depressing the Calibrate button places the Excimer Laser System in Calibrate mode. The Calibrate button is illuminated. Fluence: The Fluence button adjusts the output energy of the Excimer Laser System. The fluence value is increased or decreased by depressing the appropriate Fluence button.

  • Page 28: Reset

    Reset and Standby: The Standby and Reset buttons are depressed simultaneously to bypass the five minute warm-up phase if the Excimer Laser System parameters, fluence and rate, are set. The CVX-300 must not be off for longer than 30 seconds in order to use this feature. See Warning below.

  • Page 29: Advisory, Indicator And Status Lights

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Advisory, Indicator and Status Lights YELLOW GREEN YELLOW RED when when Power when in when in LASING Error lamp STANDBY READY is ON mode mode Status lamps at top of...

  • Page 30: Fault

    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 fiber.

  • Page 31: Standby

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Standby: The Standby 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.

  • Page 32: Operational Modes

    Connect the end of the power cord into the receptacle located on the lower back panel of the CVX-300. Ensure power cord is fully seated into the power receptacle. Insert the other end of the power cord into a wall receptacle with the proper output voltage.

  • Page 33: Testing Mode

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Testing Mode The system executes an internal test which takes approximately 30 seconds. The first part of self-test is a control panel lamp test in which all status buttons and advisory lights, except standby, and green status light on top of the control panel are illuminated simultaneously for approximately 5-7 seconds.

  • Page 34: Warm-Up Mode

    If a malfunction is detected by the internal test, a fault code will be visible in the display window and the Excimer Laser System locks in a non-operational mode. The malfunction 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  ) position for 5 seconds and then to the ON ( | )

  • Page 35: Standby Mode

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Figure 3 Warm-up The Warm‑up mode continues for five minutes. The display window shows the remaining time in the Warm‑up mode. The warm-up period allows various components inside the unit to reach normal operating temperatures.

  • Page 36: Calibrate Mode

    Calibrate Mode Insert the coupler, on the proximal end of the fiber optic catheter, into the center of the connector on the CVX-300. The appropriate calibration values will be displayed for the device in use. (Figure 5) Note: Calibration settings may vary between devices. The recommended settings are located in the device’s Instruction for Use.
  • Page 37 English / English Figure 5 Calibrate Allow the CVX-300 time to complete the five-minute warm-up period and enter the Standby mode. Clean the face of the energy detector with an alcohol prep before and after each use. Depress the Calibrate button to enter Calibrate mode.
  • Page 38 Depress and hold the footswitch down until lasing stops. The Lasing light and red lasing status light on the top of the control panel illuminates and the CVX-300 begins lasing. Note: the Power Error lamp may flicker momentarily during the Calibration cycle as the laser adjusts energy output (an audible tone will be heard when the Power Error...

  • Page 39: Standby Mode (Returning From Calibrate Mode)

    12. If a problem occurs during the calibration process, the CVX-300 will return to the Standby mode and the fault light will be illuminated. A numeric code will also appear in the display.

  • Page 40: Standby Mode (Returning From Ready Mode)

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Figure 8 Standby Standby Mode (Returning from Ready Mode) Standby mode is entered from Ready mode by depressing the Standby button. The Standby button and green status light on the top of the control panel are illuminated.
  • Page 41 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Figure 9 Ready The Excimer Laser System is now ready to use in a procedure. Depressing the footswitch causes the red Lasing light and red status light on the top of the control panel to illuminate.
  • Page 42 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English While the Excimer Laser System is lasing, the total treatment time is stored. To retrieve the treatment time, stop lasing and depress the Treatment Time button. The Min/Sec indicator light illuminates and the total treatment time is visible in the display window.
  • Page 43 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Figure 12 Pulses Delivered 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.

  • Page 44: Power Down

    When a fault is detected by the system, a code number is displayed in the middle of the display window corresponding to the appropriate fault. Refer to the Troubleshooting Section of this manual. Always record the fault code number and report it to Spectranetics Customer Service.

  • Page 45: Maintenance

    5) Clean the face of the energy detector with an alcohol prep. 6) Turn the CVX-300 on, warm it up, and calibrate the laser with a Reference Catheter. If any of the above do not pass visual inspection or the Reference Catheter does not calibrate, contact Spectranetics prior to using the laser.
  • Page 46 Service should only be completed by a Spectranetics Certified Field Service Engineer. In the event that the laser has exceeded its useful life, contact Spectranetics to return the laser or for information regarding disposal of the equipment. See Instructions for Use for each single-use device for disposal of these CVX-300 accessories.

  • Page 47: Verification Of Calibration

    Aim the distal end of the Reference Catheter directly at the center and one to two inches away from the front surface of the Energy Detector on the front of the CVX-300. Depress the Calibrate button on the CVX-300 display panel.
  • Page 48 Depress and hold the Footswitch down until the laser stops and the “Cal OK’ light is illuminated. 10. Record the energy reading in mJ shown on the CVX-300 display panel. 11. Depress the Ready button on the CVX-300 display panel.

  • Page 49: Troubleshooting

    • Ensure the fiber optic catheter Fiber indicator is illuminated. handle is fully inserted into the coupler. Service indicator is illuminated. • Call Spectranetics Customer Service for assistance. 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978 Customer Service, Europe +31 33 434 7050...
  • Page 50 Excimer Laser System Version 26 Operator’s Manual ® English / English Power error indicator • Call Spectranetics is illuminated constantly. Customer Service for assistance. A fault occurs during Warm‑up • Refer to the Fault Code Table at the end of this section.
  • Page 51 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Troubleshooting: CVX-300 Fault Codes & Error Lamps Fault Problem Try this… Code Description 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...
  • Page 52 10 seconds. If the Power Error indicator turns off and remains off, reintroduce the fiber device and continue. Report the incident to Spectranetics after the case is complete. If the Power Error indicator remains illuminated, turn the unit OFF ( ), then back ON ( | ).

  • Page 53: Glossary

    CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Glossary Align To adjust the components of a system for proper interrelationship. Circuit breaker An electromagnetic device which opens a circuit automatically when the current exceeds a pre-determined value.
  • Page 54 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English Joule One Watt second; a unit of energy. Laser (An acronym) Light Amplification by Stimulated Emission of Radiation: a device which amplifies light, then releases it in a coherent powerful beam.
  • Page 55 CVX-300 Excimer Laser System Version 26 Operator’s Manual ® English / English This page is intentionally left blank. 7030-0068-26 28Jul16 Customer Service, Canada/US (719) 633-8333 / (800) 231-0978 Customer Service, Europe +31 33 434 7050...
  • Page 56 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. 7030-0068-26 28Jul16...

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