VenaCure 1470 Laser Operator Manual Ver 3.0 Sept 2012

VenaCure® 1470nm Laser SECTION 1

WELCOME

Thank you for purchasing an AngioDynamics VenaCure 1470 laser. This is a high quality medical instrument that will give many years of service if used and cared for according to the instructions in this operator manual. Before going any further it is important that the Product Information on page 4 is completed at installation for future reference. The Warranty Form in the accompanying Warranty Booklet must also be filled in and the form returned to AngioDynamics to complete the registration process.

INTRODUCTION This manual describes the operation of the VenaCure 1470 laser. This product is to be used only by experienced, trained operators familiar with laser procedures. Before using this instrument for the first time, read the Safety & Warnings (section 2) and the Operating Instructions (section 3). 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. The VenaCure 1470 laser incorporates a Class 4 (IV) InP (Indium Phosphide) diode laser with a wavelength of 1470nm (±20nm). The VenaCure 1470 laser incorporates a visible Class 3R (IIIa) diode laser aiming beam with a wavelength of 635-660nm and a maximum power output of 5mW.

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VenaCure® 1470nm Laser DESCRIPTION OF THE VENACURE 1470 LASER The VenaCure 1470nm laser has been designed for use with the AngioDynamics range of VenaCure ® EVLT procedure kits for Endovenous Laser Treatment. The VenaCure 1470 laser system consists of three main components:   

The main enclosure houses the laser module containing the optics, heatsink, microprocessorbased control electronics and power supplies The footswitch to activate the laser output when in READY mode The fiber for delivering the laser radiation (sold separately)

Key features of the VenaCure 1470 laser include:      

12W power output Compact & portable Intuitive user interface 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. 1

Welcome

2

Safety & Warnings

Explains the general warnings and precautions that must be followed to ensure that the VenaCure 1470 laser is used in a safe manner.

3

Operating Instructions

Provides detailed instructions on how to install and operate the VenaCure 1470 laser.

4

Technical Information

Explains all the maintenance procedures that can be performed by the user.

5

Warranty

Contains the AngioDynamics warranty policy.

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VenaCure® 1470nm Laser PRODUCT INFORMATION Laser Serial Number

Software Version ... (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:

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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 ...8 Warnings ...9 EMC Warning...10 Safety classifications, hazards and precautions ...11 Eye Injury ...12 Burns ...13 Reflection Warning...13 Explosion Hazard Warning ...13 Vapor Plume ...13 Clinical Indications & ContraIndications ...14 Clinical Warnings ...15 Clinical Precautions ...15 Safety labeling ...16 Safety features ...17 EMC Declaration ...18 ESD Precautionary Procedures ...22 Essential Performance ...22 FCC Declaration ...22 Section 3 Operating Instructions ...23 Introduction ...23 Conventions ...23 Summary...23 Installation and set-up ...25 Front Panel Controls ...27 Rear Panel Controls...29 Fiber Recognition System ...31 Operating Instructions ...32 Linear Fluence ...38 Emergency Override ...39 Set-up Menu ...40 Statistics ...44 Section 4 Technical information ...46 Specifications ...46 Classification ...47 Cleaning ...47 Caring for fibers ...47 Troubleshooting ...48 Accessories ...50 Sterilization of Optical Fibers ...51 Fuse Replacement ...51 Disposal ...51 Software updates ...51 Servicing ...51 Laser Power Output ...52

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VenaCure® 1470nm Laser Technical Description ... 54 Section 5 Warranty ... 57 Manufacturer’s Warranty policy... 57

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VenaCure® 1470nm Laser SECTION 2

SAFETY & WARNINGS

SYMBOLS USED IN THIS MANUAL

This symbol indicates caution should be taken, as there may be a potentially hazardous situation that could result in injury to personnel or damage to the equipment.

This symbol indicates the possibility of a non-radiation hazard that may result in severe injury to personnel within the vicinity of the equipment.

This symbol indicates the possibility of an electrical hazard that could cause injury to personnel within the vicinity of the equipment or damage to the equipment.

This symbol indicates the possibility of exposure to hazardous laser radiation that could cause injury to personnel within the vicinity of the equipment.

This symbol indicates personnel within the vicinity of the equipment should wear appropriate eye protection.

This symbol indicates an important point to be noted.

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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)

Power On

Type B applied part Intentional radiator

Follow Electrostatic Discharge (ESD) precautions

The component or accessory is non-sterile

Do not re-use

Do not use if packaging is damaged Expiration date Batch number Product re-order code

Sterile by Ethylene Oxide

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VenaCure® 1470nm Laser WARNINGS

US Federal Law restricts the use of this device to sale by or on the order of a physician. Intended for use only by trained physicians/surgeons familiar with laser procedures.

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

This product must be stored at temperatures between 0C (32F) and 55C (130F). If stored at temperatures outside these limits for a period of time, the laser requires up to 12 hours acclimating prior to operation. Failure to observe this could result in invalidation of the warranty. If the product has been stored at a temperature above 30C (86F), the laser’s cooling system may take a few minutes to stabilize after it has been switched on. A message will be displayed on the screen to indicate this.

The laser is not designed to operate at temperatures below 10C (50F).

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.

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VenaCure® 1470nm Laser EMC WARNING Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. The VenaCure 1470 laser may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. 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. If electromagnetic interference is experienced, relocate or re-orientate the VenaCure 1470 laser or the other equipment. Accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the VenaCure 1470 laser as replacement parts for internal components, may result in increased emissions or decreased immunity of the VenaCure 1470 laser. ‘Immunity’ is the ability of a device to function normally when operated in the presence of electromagnetic radiation. The following cables are compatible with the VenaCure 1470 laser: 

Foot Switch Assembly (supplied with laser): AngioDynamics part number: AS1/A0/0002.



Remote Interlock Lead (if required): Lemo connector (supplied with laser): AngioDynamics part number: CON/51/0003 Ferrite sleeve (Farnell part number: 898-454). Screened twisted pair cable 7/0.2 (Farnell part number: 140-457), maximum length 4m (13ft). Note: The ferrite sleeve should be fitted to the remote interlock cable, at a maximum of 75mm (3 inches) from the Lemo connector.



Remote Interlock Bypass (supplied with laser): AngioDynamics part number: AS1/A3/0024.



IEC Power Lead (supplied with laser): AngioDynamics part number: CBL/02/0040.

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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. The VenaCure 1470 laser conforms to the requirements of Council Directive 93/42/EEC of the Council of European Communities (Medical Devices Directive). Affixing the ‘CE Mark’ to the instrument indicates conformity to this directive.

0086 The local Laser Safety Officer should review all procedures for safety prior to system use.

A Class 4 (IV) laser is hazardous to the eye from the direct beam and diffuse reflections. It also presents significant skin and fire hazard.

Avoid eye or skin exposure to direct or scattered radiation. Take all necessary protective measures, as explained in the rest of this section, in areas where the laser is being used.

All personnel must wear approved protective glasses appropriate to the wavelength of the VenaCure 1470 laser to reduce the risk of eye damage.

The aiming beam is a Class 3R (IIIa) laser and an unprotected eye may view the beam scattered from a non-reflective surface. Do not stare into the aiming beam or view it directly with optical instruments.

Avoid directing the laser beam anywhere other than the treatment area or calibration ports.

Before using a fiber, check it carefully for any signs of damage during storage or transit. Protective caps should be in place over SMA connectors. Do not use if there is any sign of damage. The VenaCure 1470 laser is a portable laser weighing up to 12kg (26lb). All standard safety procedures for lifting should be applied when moving the instrument. 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.

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VenaCure® 1470nm Laser

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. It is recommended that all staff receive an explanation of the ESD warning symbol and made aware of the ESD precautionary procedures described at the end of this section.

EYE INJURY Extreme caution should be taken when operating the VenaCure 1470 laser near the eyes.

All personnel must wear approved protective glasses to reduce the risk of eye damage. The patient should wear protective glasses. The local Laser Safety Officer should review all procedures for safety prior to system use. All protective glasses should be designed for protection from continuous wave laser radiation in the wavelength range 1440 – 1500nm. The degree of optical filtration (Optical Density or OD) depends on the application and should be assessed and approved by the appointed Laser Safety Officer for the establishment. The recommendations of European Standards EN 60825-1 or EN 207 are appropriate to assessing laser eye risk. Note that the standards assume a viewing distance from the source of light of more than 100mm (4 inches). AngioDynamics supplies laser safety glasses marked in accordance with EN 207 as L3 or greater. Contact your local AngioDynamics representative if these are required. The ‘Nominal Ocular Hazard Distance’ is 0.31m (1 foot). Use of optical accessories and viewing aids, which may increase the eye exposure beyond a safe limit, should be subject to the approval of the Laser Safety Officer. Never look directly into the laser aperture even if wearing safety glasses. Serious eye injury could result.

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VenaCure® 1470nm Laser BURNS

Irradiation of any substance or material other than the target treatment of varicose veins and varicosities may result in a laser burn.

REFLECTION WARNING

Avoid placing reflective materials such as glass, metals and polished plastic in the beam.

EXPLOSION HAZARD WARNING Avoid using flammable or explosive anesthetic gases that may be ignited by the laser. 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.

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VenaCure® 1470nm Laser 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 superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recommended power range is between 5W and 7W. A specific level is not recommended, but is left to user preference and best medical judgement.

Contraindications

The VenaCure 1470 laser is contraindicated for:   

Potential Complication

Patients with thrombus in the vein segment to be treated Patients with an aneurysmal section in the vein segment to be treated Patients with peripheral artery disease as determined by an Ankle-Brachial Index < 0.9

The potential for complications exists, including: 

Vessel Perforation



Thrombosis



Pulmonary Embolism



Phlebitis



Hematoma



Infection



Skin Pigmentation Alteration



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.)

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VenaCure® 1470nm Laser CLINICAL WARNINGS

As with any conventional surgical operations, adverse reactions may occur following treatment.

Use cautiously with patients who have had difficulty with previous laser procedures.

CLINICAL PRECAUTIONS General Precautions 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. Please contact your AngioDynamics representative for training materials available on the use of this equipment. Specific parameters are not recommended, but are left to operator preference and best medical judgment.

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VenaCure® 1470nm Laser SAFETY LABELING

Location of Safety Labeling Safety labels for the VenaCure 1470 laser are positioned as indicated below.

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.

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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



READY and STANDBY modes



manual reset mechanism



shutter (not mechanical)



emergency switch



location of controls



safety labels (see diagram)



identification and compliance label (see diagram)



aiming beam

The VenaCure 1470 laser is equipped with the following additional safety features: 

self-test



laser condition monitoring



pulse duration monitoring



power diodes watch-dog



microprocessor watch-dog



mains power fail protection



power supply monitor



temperature monitors

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VenaCure® 1470nm Laser

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

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Electromagnetic emissions – guidance The VenaCure 1470 laser uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The VenaCure 1470 laser is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Not applicable

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VenaCure® 1470nm Laser 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2

+/- 6kV contact

+/- 6kV contact

+/- 8kV air

+/- 8kV air

Electrical fast transient / burst IEC 61000-4-4

+/- 2kV for power supply lines

+/- 2kV for power supply lines

+/- 1kV for input/output lines

+/- 1kV for input/output lines

+/- 1kV differential mode

+/- 1kV differential mode

+/- 2kV common mode

+/- 2kV common mode

<5% UT (>90% dip in UT) for 0,5 cycle

<5% UT (>90% dip in UT) for 0,5 cycle

40% UT (90% dip in UT) for 5 cycles

40% UT (90% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 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) for 5 sec

3A/m

3A/m

Surge IEC 61000-4-5

Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) IEC 61000-4-8 NOTE

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the VenaCure 1470 laser requires continued operation during mains interruptions, it is recommended that the VenaCure 1470 laser be powered from an uninterruptible power supply or battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

UT is the a.c. mains voltage prior to application of the test level.

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VenaCure® 1470nm Laser 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. Immunity test IEC 60601 test level Compliance Electromagnetic environment – guidance level Portable and mobile RF communications equipment should be used no closer to any part of the VenaCure 1470 laser, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance. Conducted RF IEC 61000-4-6

3Vrms 150kHz to 80MHz

3Vrms

d = 1.2 √P

Radiated RF IEC 61000-4-3

3V/m 80MHz to 2,5GHz

3V/m

d = 1.2 √P

80MHz to 800MHz

d = 2.3 √P 800MHz to 2,5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as a determined by an electronic site survey, should be less than the compliance level in each b frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed 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. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the VenaCure 1470 laser. b Over the frequency range 150kHz to 800MHz, field strengths should be less than 3V/m.

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