Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for AngioDynamics VenaCure 1470 Pro
Summary of Contents for AngioDynamics VenaCure 1470 Pro
- Page 1 DGM001357 (User Manual VenaCure 1470 Pro – WW) REVISION HISTORY Revision no. Description Prepared by: Approved by: Date First release M. Lusso E. Rubino 07/05/2018 Revision based on FDA feedbacks E. Rubino P. Bimbi 16/08/2018 Device pictures update E. Rubino P.
- Page 2 VenaCure 1470 Pro 1470 nm Diode Laser System User Manual DGM001357.02...
- Page 3 Thank you for choosing an AngioDynamics Laser product. In order to attain the best results with VenaCure 1470 Pro laser systems and to avoid risks of dangerous faults, please be sure that you carefully and completely read this user manual before starting any operation.
-
Page 4: Table Of Contents
Main Screen .......................... 24 Fiber INFO area ......................25 Modulation modes ......................26 Main menu ..........................27 Program Menu ........................28 Save ..........................28 Save as new ........................28 Change name ........................ 29 Erase program ....................... 29 DGM001357.02 UM VenaCure 1470 Pro... - Page 5 Repairs and modifications of the device ................43 TECHNICAL SPECIFICATIONS ....................44 General Specifications ......................44 Laser characteristics ......................44 ACCESSORIES and DETACHABLE PARTS ................45 Accessories ..........................45 Detachable parts ........................45 Appendix A: EMC Tables......................46 DGM001357.02 UM VenaCure 1470 Pro...
-
Page 6: General Information
This device is a Laser classified as Class 4 according to IEC 60825-1. Distributed by: AngioDynamics, Inc 603 Queensbury Ave. Queensbury, NY 12804 Manufactured by: Quanta System S.p.A. Via Acquedotto, 109, 21017 Samarate (VA) ITALY www.quantasystem.com DGM001357.02 UM VenaCure 1470 Pro... -
Page 7: Symbols And Abbreviations Used In This Manual
Nominal Ocular Hazard Zone Maximum Permissible Exposure µm Units, micrometer Units, Second mrad Units, milliradiant Units, Watt Units, Joule J/cm Units, Joule per square centimeter Units, centimeter Optical Density Continuous laser according to EN207 Glasses protection degree DGM001357.02 UM VenaCure 1470 Pro... - Page 8 Pulse duration laser off Units, Pressure °C Units, Celsius degree Units, Kilogram Percentage A label that indicates the OFF configuration of the key switch A label that indicates the ON configuration of the key switch DGM001357.02 UM VenaCure 1470 Pro...
-
Page 9: Safety Instructions
Be instructed by internal personnel about laser, electrical and other risks related to the laser operation within the working area (laser radiation, electric shock etc.) The entrance is absolutely FORBIDDEN IF there is no operator inside the working area. DGM001357.02 UM VenaCure 1470 Pro... -
Page 10: Eye And Skin Exposure
Please, refer to previous Section 2.5 for further details concerning the protection level in googles. Laser system has to be used in a closed area that does not allow the escape of direct, reflected or transmitted laser radiation. DGM001357.02 UM VenaCure 1470 Pro... -
Page 11: Potential Fire Hazard
Cotton wool and similar materials, when saturated with oxygen can catch fire due to high temperature emitted by laser. • Before using the laser let evaporate any solvents or glues or flammable solutions used to clean or disinfect. • Attention: endogenous gases can catch fire or explode. DGM001357.02 UM VenaCure 1470 Pro... -
Page 12: Emission Of Plume
It is forbidden to dispose of the device as municipal waste but has to be collected separately according to the WEEE Directive (Waste Electrical and Electronic Equipment). The penalties for violating the requirements of the law are severe. DGM001357.02 UM VenaCure 1470 Pro... -
Page 13: Labels
Label 3 Warning label – hazard symbol according to IEC 60825-1 Label 4 Rating label Label 4b Rating label (Manufacturer and Distributer addresses) Label 5 Remote interlock connector label Label 6 Type CF applied part DGM001357.02 UM VenaCure 1470 Pro... - Page 14 Label 11 Key switch ON/OFF Complies with FDA performance standards for Label 12 laser products except for deviations pursuant to FDA compliance label Laser Notice No. 50, dated June 24, 2007 Label 13 UDI label DGM001357.02 UM VenaCure 1470 Pro...
-
Page 15: Device Front View
Device front view LABEL 2 LABEL 7 LABEL 6 Device rear view LABEL 4b LABEL 4 LABEL 12 LABEL 5 LABEL 9 LABEL 11 LABEL 10 LABEL 13 DGM001357.02 UM VenaCure 1470 Pro... -
Page 16: Device Side And Top Views
Device side and top views LABEL 1 LABEL 3 LABEL 8 DGM001357.02 UM VenaCure 1470 Pro... -
Page 17: Working Area Requirements And Installation
The suggested minimum room size is 3X3 meters. Allow 50 cm of clearance on both sides of the device permitting the air vents are not being obstructed. The Laser Device can be easily moved from room to room. Make sure that space and electrical socket requirements are available everywhere it has to work. DGM001357.02 UM VenaCure 1470 Pro... -
Page 18: Installation Procedure
Operation of the device Caution: Do not start any action with the laser device before the official personnel have performed the installation procedure. The warranty does not cover any damage to the laser device before the installation. DGM001357.02 UM VenaCure 1470 Pro... -
Page 19: Remote Door Interlock Connection
Warning: Do not wrap the footswitch with any plastic (or other material) film or cover bag, unless authorized by the manufacturer. The unauthorized use of wrapping bags/films may block the pedal in pressed position and cause unwanted laser emission. DGM001357.02 UM VenaCure 1470 Pro... -
Page 20: Optical Fiber Connection
In order to connect the fiber to the device, pull the sliding knob (2) down, opening the external protection shutter and accessing the fiber connector. The device accepts only AngioDynamics fibers with SMA905 connector and RFID Recognizer System (with proprietary internal code). -
Page 21: Device Description
VenaCure 1470 Pro is a diode laser system emitting at 1470 nm wavelength, with maximum output power 15 W. Only the use of optical fibers manufactured by AngioDynamics (provided with RFID tag with proprietary internal code) is allowed with the VenaCure 1470 Pro laser system. -
Page 22: Electrical Controls
This check can be done by placing the fiber perpendicularly to a surface with the aiming beam activated. Warning: For proper use, refer to the Instruction for Use for VenaCure EVLT procedure kits. DGM001357.02 UM VenaCure 1470 Pro... -
Page 23: Operating Instructions
Turn the key (clockwise) in order to start up the system. When the system switches on, the device beeps three times displaying the loading screen: After a few seconds, the Welcome screen is displayed: Press anywhere on the screen to continue. DGM001357.02 UM VenaCure 1470 Pro... - Page 24 The Home screen appears: select the preset program if previously saved by the user to continue: By pressing twice, the Main screen appears: DGM001357.02 UM VenaCure 1470 Pro...
-
Page 25: Main Screen
Treatment counter reset button: by clicking on it, the user can reset the treatment counters. • Modulation area: by clicking on, the user can choose the modulation modes among: Continuous, Single Pulse, Continuous Pulsed, editable Ton and Toff (for pulsed mode). Refer to Section 5.2.2. DGM001357.02 UM VenaCure 1470 Pro... -
Page 26: Fiber Info Area
Number of uses • Status The RFID system accepts only AngioDynamics fibers with proprietary internal code. If an invalid, or expired fiber is connected, the system does not enter in READY mode. Maximum energy/fiber session The maximum value of deliverable energy per fibers is 10,000 J. -
Page 27: Modulation Modes
By pressing READY and then the footswitch, laser pulses emission begins, until the footswitch is released (as in the Continuous mode). A counter displays the total Energy (J) emitted, the total number of shoots and the emission Frequency (Hz). DGM001357.02 UM VenaCure 1470 Pro... -
Page 28: Main Menu
Session information: it may display “NO”, or “Started”; in this case, with an indication of the “session duration” an of the “total emitted energy” (in kJ). • Diagnostics: this function open the Input/Output information, useful for diagnostic purpose: DGM001357.02 UM VenaCure 1470 Pro... -
Page 29: Program Menu
Main Screen. Click on the ENTER button to confirm Save as new This function allows to save a new program with a new name and customized parameters as follows: • Select a standard program; DGM001357.02 UM VenaCure 1470 Pro... -
Page 30: Change Name
OK to confirm and return to the Programs Menu: Change name This function allows to rename a previous saved program using the keypad. Erase program By selecting this function, it is possible to erase a previously saved program. The following popup screen appears: DGM001357.02 UM VenaCure 1470 Pro... -
Page 31: Settings Menu
After the parameters are set, enter Ready mode: the system is ready to emit laser radiation. The first time you switch from Standby to Ready status, the following Warning appears: Press OK to confirm, or ESC to exit and return in Standby mode. DGM001357.02 UM VenaCure 1470 Pro... - Page 32 After a few seconds the system enter in READY status: in this status the user can enable laser emission by pressing the footswitch: For detailed operating procedure refer to the AngioDynamics fibers instruction for use. DGM001357.02 UM VenaCure 1470 Pro...
- Page 33 (10 cm in the example above), the laser device does not interrupt the procedure, but inform the user of the exceeding laser treatment by turning the Residual Length and the Residual Energy to negative values. DGM001357.02 UM VenaCure 1470 Pro...
-
Page 34: Alarms
By entering in Main menu → Diagnostics, it is possible to see the error details. In the event of an Error, the Error message is displayed in red in the Diagnostics screen: ➔ In the event of laser system stop, transfer this information to the AngioDynamics Service. DGM001357.02 UM VenaCure 1470 Pro... -
Page 35: Shut Down Procedure And Protection Against Authorized Use
When the laser device is not in use, it must be protected from any unauthorized use: in order to avoid improper use of the device, the key shall be removed when the device is not being used. DGM001357.02 UM VenaCure 1470 Pro... -
Page 36: Clinical Application
Neovascularization • Paresthesia due to thermal damage of adjacent sensory nerves • Anesthetic Tumescence • Non-Target Irradiation • Hemorrhage • Necrosis • DEHP Exposure • Skin Burns and Pain (This is not an exhaustive list.) DGM001357.02 UM VenaCure 1470 Pro... -
Page 37: Suggested Parameters
Warning: As with any conventional surgical operations, adverse reactions may occur following treatment. Use cautiously with patients who have had difficulty with previous laser procedures. Suggested parameters Specific parameters are not recommended, but are left to operator preference and best medical judgment. DGM001357.02 UM VenaCure 1470 Pro... -
Page 38: Calibration And Maintenance
This symbol is for information only and does NOT prevent the VenaCure 1470 Pro laser from being used. Please contact your AngioDynamics representative for further details. Type and nominal value of the fuses The fuses utilized for the main power connector have the following specifications: •... -
Page 39: Device Cleaning
Do not use any alcohol solution to clean the display. Optical fiber maintenance Only the use of AngioDynamics Fibers is allowed with the VenaCure 1470 Pro Laser System. Caution: Before each use, check the shape of the aiming beam to verify the effective quality of the beam pattern. -
Page 40: Check The Power Cable
If labels are damaged, they must be replaced immediately in accordance with the plan shown in labeling plan 2.13. Warning: Use of controls, adjustments or demonstration of procedures other than those specified herein may result in hazardous radiation exposure. DGM001357.02 UM VenaCure 1470 Pro... -
Page 41: Troubleshooting
• If the error persists, call Service The fiber is not connected • Connect the fiber Optical fiber alarm FIBER DETACHED when pressing the READY button DGM001357.02 UM VenaCure 1470 Pro... - Page 42 STANDBY mode. The fiber has been already FIBER USE used and was disconnected for TERMINATED. • Replace the fiber a time greater than 5 minutes. Fiber was The fiber cannot be used disconnected anymore. DGM001357.02 UM VenaCure 1470 Pro...
-
Page 43: Customer Service
CUSTOMER SERVICE Contact Information Please contact AngioDynamics to report any malfunctions, manufacturing defects or non- conformities of your device, or for calibration and preventative maintenance. US Customer Service 800-772-6446 Go to Angiodynamics.com and “About US” for International Customer Service contact information. -
Page 44: Repairs And Modifications Of The Device
• It is recommended to replace all the damaged components • Use only manufacturer approved replacement parts • Any unauthorized changes or alterations are not permitted Please keep on hand the Serial Number of your device. DGM001357.02 UM VenaCure 1470 Pro... -
Page 45: Technical Specifications
Up to 2500 ms Repetition Rate Up to 2000 Hz Beam divergence 220 mrad Beam transmission Optical Fiber Aiming Beam 635 nm, <4mW, class 3R MPE (W/m 1000 NOHD (m) 0,31 Exposure Time (s) Goggles DGM001357.02 UM VenaCure 1470 Pro... -
Page 46: Accessories And Detachable Parts
Accessories • User Manual • Laser warning sign (quantity =2) • Test fiber • Protective goggles (quantity =3) Detachable parts • IEC power cable • Footswitch • Remote Interlock bypass connector • 2 x Key DGM001357.02 UM VenaCure 1470 Pro... -
Page 47: Appendix A: Emc Tables
Harmonic emission Compliant connected to the public supply network in low IEC 61000-3-2 voltage, but only in buildings like the hospital with Voltage fluctuation/flicker emission dedicated supply system. Compliant IEC 61000-3-3 DGM001357.02 UM VenaCure 1470 Pro... - Page 48 (50/60Hz) magnetic 30 A/m Compliant characteristic of a typical field location in a typical commercial IEC 61000-4-8 or hospital environment Note: Ut is the AC mains voltage prior to application of the test level DGM001357.02 UM VenaCure 1470 Pro...
- Page 49 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the b) Over the frequency range 150 KHz to 80 MHz, field strength should be less than 3 V/m. DGM001357.02 UM VenaCure 1470 Pro...
- Page 50 Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. AngioDynamics, the AngioDynamics logo, and the VenaCure 1470 Pro logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary.
Need help?
Do you have a question about the VenaCure 1470 Pro and is the answer not in the manual?
Questions and answers