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Related Manuals for AngioDynamics VenaCure 1470
Summary of Contents for AngioDynamics VenaCure 1470
- Page 1 DIODE LASER OPERATOR MANUAL Version 2.0 May 2011 MAN/31/0075 US Manufactured in the United Kingdom by AngioDynamics UK Limited AngioDynamics, VenaCure EVLT, EVLT and VenaCure are Registered Trademarks of AngioDynamics Inc. 2011 AngioDynamics, Inc.
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Page 2: Welcome
The operator must become familiar with all the controls before commencing any therapy. The VenaCure 1470 laser is a diode laser capable of delivering up to 12W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture. -
Page 3: Description Of The Venacure 1470 Laser
Automatic fiber recognition for use with the AngioDynamics Endovascular Laser procedure kits • Minimal maintenance & service • Memory card slot for transfer of data between the VenaCure 1470 laser and a PC • ABOUT THIS MANUAL This manual is broken down into five sections as described below. - Page 4 (Note: This is shown on the screen displayed at start-up.) Date Installed ............................Installed by .............................. Signed ..............................Print Name ............................. Organization ............................For service, parts or repair, contact your local AngioDynamics representative: VenaCure 1470 Laser Operator Manual Page 4 Version 2.0...
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Page 5: Table Of Contents
VenaCure® 1470nm Laser CONTENTS Section 1 Welcome ..........................2 Introduction ..............................2 Description of the VenaCure 1470 laser ....................3 About this Manual ............................3 Contents ..............................5 Section 2 Safety & Warnings ......................... 7 Symbols used in this manual ........................7 Symbols used on AngioDynamics products .................... - Page 6 VenaCure® 1470nm Laser Technical Description ..........................54 Section 5 Warranty ..........................57 Manufacturer’s Warranty policy....................... 57 VenaCure 1470 Laser Operator Manual Page 6 Version 2.0...
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Page 7: Safety & Warnings
This symbol indicates personnel within the vicinity of the equipment should wear appropriate eye protection. This symbol indicates an important point to be noted. VenaCure 1470 Laser Operator Manual Page 7 Version 2.0... -
Page 8: Symbols Used On Angiodynamics Products
VenaCure® 1470nm Laser SYMBOLS USED ON ANGIODYNAMICS PRODUCTS The following symbols are used on the VenaCure 1470 laser and on accessories provided by AngioDynamics. Consult instructions for use Caution, consult accompanying documents Power Off Power Off (only for a part of equipment) -
Page 9: Warnings
This product contains a lithium battery, which should only be replaced by authorized service personnel. Replace the battery only with the same or equivalent type. Dispose of used batteries according to the manufacturer’s instructions and local disposal requirements. VenaCure 1470 Laser Operator Manual Page 9 Version 2.0... -
Page 10: Emc Warning
Portable and mobile RF communications equipment can affect medical electrical equipment. The VenaCure 1470 laser should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the VenaCure 1470 laser should be observed to verify normal operation in the configuration in which it will be used. -
Page 11: Safety Classifications, Hazards And Precautions
VenaCure® 1470nm Laser SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS The VenaCure 1470 laser is classified as a Class 4 (IV) laser product in compliance with FDA 21 CFR 1040.10 and 1040.11, UL 60601-1, EN 60601-1, EN 60601-1-2, EN 60601-2-22 and EN 60825-1. -
Page 12: Eye Injury
VenaCure® 1470nm Laser There are no user serviceable parts in the VenaCure 1470 laser. The exterior cover should only be removed by a trained and authorized laser service technician. Pins of connectors identified with the Electrostatic Discharge (ESD) warning symbol should not be touched. Connections should not be made to these connectors unless the ESD precautionary procedures detailed on page 22 are followed. -
Page 13: Burns
Avoid using other flammable or fume-emitting substances (e.g. ether, iodine solution, collodion, and alcohol) in the operative field. VAPOR PLUME AngioDynamics recommends that a smoke evacuator or in-line filter be used when lasing. VenaCure 1470 Laser Operator Manual Page 13... -
Page 14: Clinical Indications & Contraindications
CLINICAL INDICATIONS & CONTRAINDICATIONS Indications The VenaCure 1470 laser is intended for use in delivering up to 12 Watts of continuous wave or pulsed radiation with AngioDynamics EVLT Procedure Kits in endovascular coagulation of the Greater Saphenous Vein in patients with... -
Page 15: Clinical Warnings
Only operators who have been trained in the use of lasers and are thoroughly familiar with this Operator Manual should use the VenaCure 1470 laser. The information provided in this section is not intended to be all-inclusive and it is not intended to replace operator training or experience. -
Page 16: Safety Labeling
Aperture Label (Visible when aperture cover is open) Safety Label Product Identification Labeling Product identification labeling is located on the rear of the VenaCure 1470 laser. Made in the United Kingdom by: This product complies with IP21 AngioDynamics UK Ltd. -
Page 17: Safety Features
VenaCure® 1470nm Laser SAFETY FEATURES The VenaCure 1470 laser includes a number of safety features, which are provided in accordance with the requirements of the appropriate standards. protective housing • remote interlock bypass • key switch • laser radiation emission indicator, visible and audible •... -
Page 18: Emc Declaration
Guidance and manufacturer’s declaration – electromagnetic emissions The VenaCure 1470 laser is intended for use in the electromagnetic environment specified below. The customer or user of the VenaCure 1470 laser should ensure it is used in such an environment. Emissions test Compliance Electromagnetic emissions –... - Page 19 Guidance and manufacturer’s declaration – electromagnetic immunity The VenaCure 1470 laser is intended for use in an electromagnetic environment specified below. The customer or the user of the VenaCure 1470 laser should assure that it is used in such an environment.
- Page 20 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the VenaCure 1470 laser is used exceeds the applicable RF compliance level above, the VenaCure 1470 laser should be observed to verify normal operation.
- Page 21 Recommended separation distances between portable and mobile RF communications and the VenaCure 1470 laser. The VenaCure 1470 laser is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VenaCure 1470 laser can help prevent...
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Page 22: Esd Precautionary Procedures
Also, note that the RFID system must not fail to read the fiber’s tag. This will ensure that the correct product is used in combination with the VenaCure 1470 laser. Failure to read the fiber’s tag will not allow the laser to be fired. -
Page 23: Operating Instructions
VenaCure EVLT fiber is connected. This enables the laser to automatically display the preset parameters for the endovascular coagulation procedure. The following instructions focus on the most common situations, when the VenaCure 1470 laser is being used with an AngioDynamics VenaCure EVLT procedure kit, fitted with the FRS system. - Page 24 Statistics from the Main Menu. 14. To turn the VenaCure 1470 laser OFF turn the key switch and remove the key, then switch off the rear power switch. If an error message is displayed, refer to section 4 - Technical Information.
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Page 25: Installation And Set-Up
Insert the memory card into the slot on the front panel and then switch on the VenaCure 1470 laser. If the card contains the correct software upgrades for the laser they will be detected after the self-test and installed automatically. Follow the instructions on the screen, but do not switch off until ‘Upgrade complete’... - Page 26 Laser energy is delivered to the optical fiber via the laser aperture located on the front panel of the VenaCure 1470 laser. The fiber is connected by means of an SMA-905 type optical fiber connector. To insert the optical fiber connector, first remove the protective cap from the end of the fiber. Then press down on the tab of the spring-loaded cover on the front panel to reveal the laser aperture.
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Page 27: Front Panel Controls
Scroll/Confirm Standby/Ready The main operating controls for the VenaCure 1470 laser are located on the lower section of the front panel. The display and other indicators are located in the top section of the panel, as illustrated in the figure above. - Page 28 Memory Card Slot The VenaCure 1470 laser is compatible with both Multi Media Card (MMC) and Secure Digital (SD) memory cards. To ensure reliable performance only use cards with the AngioDynamics label. An AngioDynamics memory card is available as an accessory.
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Page 29: Rear Panel Controls
AngioDynamics supplies two remote interlock bypasses for facilities without or not wishing to use the door switch option. The VenaCure 1470 laser will not operate without either a remote interlock or remote interlock bypass inserted into the remote interlock socket on the rear of the laser. - Page 30 Fuse holder 2 x T6.3A H 250V Use of controls or adjustments, and or performance of procedures other than those specified herein may result in hazardous radiation exposure. VenaCure 1470 Laser Operator Manual Page 30 Version 2.0...
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Page 31: Fiber Recognition System
A miniature Radio Frequency Identification (RFID) device is located inside the gripper at the end of the fiber connected to the laser. This is read by a receiver inside the VenaCure 1470 laser whenever it is switched on and a fiber connected to it. The RFID device contains a memory chip that holds the following... -
Page 32: Operating Instructions
VenaCure® 1470nm Laser OPERATING INSTRUCTIONS Once the VenaCure 1470 laser has been correctly installed and switched on, it is operated using just two controls: SCROLL / CONFIRM Turn the knob in either direction to SCROLL through the available options highlighted on the screen. - Page 33 CONFIRM the selection. When Set at start is set to Yes, this screen will occur every time that the VenaCure 1470 laser is switched on. To prevent this, change the selection to No as follows: Turn the SCROLL knob until Set at start is •...
- Page 34 The VenaCure 1470 laser will only permit a procedure to be carried out if an AngioDynamics FRS fiber is used. An incompatible fiber will be shown on the screen as Invalid Fiber.
- Page 35 SCROLL knob and press CONFIRM. Parameter Adjustment The VenaCure 1470 laser will set the default operating parameters. Some situations may require the default parameters to be varied within lower and upper limits. A specific level is not recommended, but is left to user preference and best medical judgement.
- Page 36 If the VenaCure EVLT Pulsed mode is selected, the duration and interval of the pulses may also be adjusted. When the operating parameters of the VenaCure 1470 laser are set, turn the SCROLL knob to move the highlight to Confirm and press CONFIRM. A message will appear for a few seconds, instructing you to press the STANDBY/READY button next.
- Page 37 VenaCure 1470 laser when the laser is put into the READY mode. Screen Symbols When the VenaCure 1470 laser is in the READY mode the screen may show various symbols. The meanings of which are explained below: Power output setting...
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Page 38: Linear Fluence
Note that this feature only affects the display on the VenaCure 1470 laser and does not alter the actual operation of the laser or the way that statistics are recorded. -
Page 39: Emergency Override
The Emergency Override must be reset by means of a special reset device (AngioDynamics part number AS/598). One of these is supplied with the VenaCure 1470 laser. Each device can only be used once, after which it is advisable to contact your AngioDynamics representative as soon as possible to obtain a replacement. -
Page 40: Set-Up Menu
CONFIRM. When Set at start is set to Yes, this language selection screen will occur every time that the VenaCure 1470 laser is switched on. This option can be toggled between Yes and No by using the SCROLL knob to highlight Set at start and pressing CONFIRM. - Page 41 To observe the different modes of the aiming beam, place the VenaCure 1470 laser into READY mode by pressing the STANDBY/READY button. The aiming beam will be activated if Continuous or Follow Laser are selected.
- Page 42 Press CONFIRM when finished. The intensity adjustment will be ignored if the aiming mode is Off. To observe the intensity of the aiming beam, place the VenaCure 1470 laser into READY state by pressing the STANDBY/READY key. The aiming beam will be activated.
- Page 43 Save all details will save information about the software and procedures which are currently loaded into the VenaCure 1470 laser, to the memory card. The card can then be removed from the VenaCure 1470 laser, inserted into a reader attached to a PC and the details transferred to the PC.
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Page 44: Statistics
Setup will be added to the current Treatment. The VenaCure 1470 laser can display the statistics of the Setups for the current and previous Treatments. A new Treatment is started when the VenaCure 1470 laser is switched on, when the fiber is changed or when New treatment is selected on the Statistics menu. - Page 45 SCROLL knob until Treatments to save is highlighted and press CONFIRM. Choose the number of Treatments to save by turning the SCROLL knob and highlighted value and press CONFIRM to accept and move VenaCure 1470 Laser Operator Manual Page 45 Version 2.0...
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Page 46: Technical Information
VenaCure 1470 laser and its accessories. The VenaCure 1470 laser has been designed to operate reliably with minimal maintenance. There are no user-serviceable parts in the VenaCure 1470 laser. Always disconnect the VenaCure 1470 laser from the AC supply before performing any cleaning or maintenance procedures. -
Page 47: Classification
The system enclosure may be wiped down periodically with a cloth dampened with a mild antiseptic solution. Before cleaning always disconnect the VenaCure 1470 laser from the AC supply. Do not use any other solutions, solvents or abrasives. Take care not to get any liquid inside the enclosure. -
Page 48: Troubleshooting
TROUBLESHOOTING Error Messages The VenaCure 1470 laser is continuously monitoring its operation and performance. Should it detect a problem it will display a code and short message on the screen. To clear a message, carry out the instructions on the display. Outlined below are some messages and the appropriate action that the user should take. - Page 49 Session Fault is indicated, use the Emergency Override option. FRS Troubleshooting The AngioDynamics FRS system has been extensively tested. In the unlikely event of a problem being experienced please perform the following checks before contacting your local AngioDynamics representative for further advice.
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Page 50: Accessories
The VenaCure 1470 laser has an output connector for optical fibers with standard SMA-905 connector. Only AngioDynamics labeled fibers should be used. A list of fibers available for use with the VenaCure 1470 laser can be obtained from your AngioDynamics representative. -
Page 51: Sterilization Of Optical Fibers
T6.3A H 250V. Fuses with a different rating or specification must not be used. DISPOSAL At the end of its life, the VenaCure 1470 laser should be disposed of according to national environmental requirements or be returned to AngioDynamics. SOFTWARE UPDATES From time to time AngioDynamics may issue new procedures, upgrades and feature enhancements for the VenaCure 1470 laser. -
Page 52: Laser Power Output
Measuring the Laser Power Output The LASER SAFETY OFFICER or suitably trained service personnel should check the output power of the VenaCure 1470 laser at least annually from the date of installation, by following the procedure described below. Equipment Required •... - Page 53 VenaCure® 1470nm Laser Turn on the laser. Load and run the AngioDynamics Engineer Interface program on the PC. From the Connection menu, select Connect to Laser, choose the appropriate Comms Port and press Connect. From the Connection menu select Enter EI and enter the password.
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Page 54: Technical Description
The VenaCure 1470 laser is built in a modular fashion, enabling ease of test, assembly and service. The system has been designed so that any one module can be replaced with no performance effect on the other modules or the product as a whole. - Page 55 This card is used to transfer usage data from the laser to the user’s PC. It can also be used to transfer updated software and new procedure information into the laser. VenaCure 1470 Laser Operator Manual Page 55 Version 2.0...
- Page 56 Pulse Width Modulation Random Access Memory Real Time Clock Secure Digital memory card Single Fault Condition Serial Peripheral Interface Transistor-Transistor Logic Thermo Electric Cooling UART Universal Asynchronous Receiver/Transmitter Volts Vacuum Fluorescent Display VenaCure 1470 Laser Operator Manual Page 56 Version 2.0...
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Page 57: Section 5 Warranty
Operator Manual by any person not authorized by AngioDynamics, will invalidate the Warranty. To make a warranty claim the purchaser shall, promptly following discovery of the WARRANTY basis of claim, contact AngioDynamics in writing, by telephone, fax or Email at the CLAIMS following address: AngioDynamics Inc 603 Queensbury Ave.