AngioDynamics VenaCure 1470 User manual

Manufactured in the United Kingdom by AngioDynamics UK Limited
AngioDynamics, VenaCure EVLT, EVLT and VenaCure are Registered Trademarks
of AngioDynamics nc.  2011 AngioDynamics, nc.
DIODE LASER
OPERATOR MANUAL
Version 2.0 May 2011 MAN/31/0075 US

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 2 Version 2.0
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 nformation 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
nstructions (section 3).
The opera or mus become familiar wi h all he con rols before commencing any herapy.
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 ( V) nP ( ndium Phosphide) diode laser with a
wavelength of 1470nm (±20nm).
The VenaCure 1470 laser incorporates a visible Class 3R ( a) diode laser aiming beam with a
wavelength of 635-660nm and a maximum power output of 5mW.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 3 Version 2.0
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, microprocessor-
based 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
• ntuitive 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 nstructions Provides detailed instructions on how to install and operate the
VenaCure 1470 laser.
4 Technical nformation Explains all the maintenance procedures that can be performed by the
user.
5 Warranty Contains the AngioDynamics warranty policy.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 4 Version 2.0
PRODUCT INFORMATION
Laser Serial Number
Software Version ...................................................................................................................................
(Note: This is shown on the screen displayed at start-up.)
Date nstalled .........................................................................................................................................
nstalled by ..............................................................................................................................................
Signed ....................................................................................................................................................
Print Name .............................................................................................................................................
Organization ...........................................................................................................................................
For service, parts or repair, contact your local AngioDynamics representative:

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 5 Version 2.0
CONTENTS
Sec ion 1
Welcome ................................................................................................................................. 2
ntroduction ................................................................................................................................................ 2
Description of the VenaCure 1470 laser .................................................................................................... 3
About this Manual ...................................................................................................................................... 3
Contents ..................................................................................................................................................... 5
Sec ion 2 Safe y & 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 njury ................................................................................................................................................. 12
Burns ........................................................................................................................................................ 13
Reflection Warning .................................................................................................................................. 13
Explosion Hazard Warning ...................................................................................................................... 13
Vapor Plume ............................................................................................................................................ 13
Clinical ndications & Contra ndications .................................................................................................. 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
Sec ion 3 Opera ing Ins ruc ions ........................................................................................................ 23
ntroduction .............................................................................................................................................. 23
Conventions ............................................................................................................................................. 23
Summary .................................................................................................................................................. 23
nstallation and set-up .............................................................................................................................. 25
Front Panel Controls ................................................................................................................................ 27
Rear Panel Controls ................................................................................................................................ 29
Fiber Recognition System ........................................................................................................................ 31
Operating nstructions .............................................................................................................................. 32
Linear Fluence ......................................................................................................................................... 38
Emergency Override ................................................................................................................................ 39
Set-up Menu ............................................................................................................................................ 40
Statistics ................................................................................................................................................... 44
Sec ion 4 Technical informa ion ......................................................................................................... 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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Technical Description .............................................................................................................................. 54
Sec ion 5 Warran y ............................................................................................................................... 57
Manufacturer’s Warranty policy............................................................................................................... 57

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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.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 8 Version 2.0
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
ntentional 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

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 9 Version 2.0
WARNINGS
US Federal Law restricts the use of this device to sale by or on the order of a
physician.
ntended 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).
f 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.
f 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.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 10 Version 2.0
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 C SPR 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. f 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.
f 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.
‘ mmunity’ 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 nterlock 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 nterlock Bypass (supplied with laser):
AngioDynamics part number: AS1/A3/0024.
• EC Power Lead (supplied with laser):
AngioDynamics part number: CBL/02/0040.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 11 Version 2.0
SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS
The VenaCure 1470 laser is classified as a Class 4 ( V) 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 ( V) laser is hazardous to the eye from the direct beam and diffuse
reflections. t 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 ( a) 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.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 12 Version 2.0
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.
t 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
Ex reme cau ion should be aken when opera ing he VenaCure 1470 laser
near he 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 direc ly in o he laser aper ure even if wearing safe y glasses.
Serious eye injury could resul .

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VenaCure 1470 Laser Operator Manual Page 13 Version 2.0
BURNS
rradiation 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.
E PLOSION 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.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 14 Version 2.0
CLINICAL INDICATIONS & CONTRAINDICATIONS
Indica ions 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.
Con raindica ions
The VenaCure 1470 laser is contraindicated for:
• 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
ndex < 0.9
Po en ial
Complica ion
The potential for complications exists, including:
• Vessel Perforation
• Thrombosis
• Pulmonary Embolism
• Phlebitis
• Hematoma
• nfection
• Skin Pigmentation Alteration
• Neovascularization
• Paresthesia due to thermal damage of adjacent sensory nerves
• Anesthetic Tumescence
• Non-Target rradiation
• Hemorrhage
• Necrosis
• DEHP Exposure
• Skin Burns and Pain
(This is not an exhaustive list.)

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 15 Version 2.0
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.

VenaCure® 1470nm Laser
VenaCure 1470 Laser Operator Manual Page 16 Version 2.0
SAFETY LABELING
Location of Safety Labeling
Safety labels for the VenaCure 1470 laser are positioned as indicated below.
Product Identification Labeling
Product identification labeling is located on the rear of the VenaCure 1470 laser.
0
100-240V
500VA 50-60Hz
2 x T6.3A
H 250V
0086
IOIOI
Made in he Uni ed Kingdom by:
AngioDynamics UK L d.
Building 2000, Beach Drive,
IQ Cambridge, Wa erbeach,
Cambridge CB25 9TE
Dis ribu ed in he USA by
AngioDynamics Inc, NY 12804
This produc complies wi h
21 CFR 1040.10 and 1040.11, UL60601-1,
EN60601-1, 60601-2-22, 60825-1 IP21
This device contains an intentional radiator part number
This product complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired operation.
This device complies with Canadian RSS-210
AS/0670
FCC ID: RBQAS0670
Canada IC: 4690A-AS0670
GROUND NG REL AB L TY CAN ONLY BE
ACH EVED WHEN EQU PMENT S
CONNECTED TO AN EQU VALENT
RECEPTACLE MARKED ‘HOSP TAL
ONLY’ OR ‘HOSP TAL GRADE’
PP/1149
US Pa en no. 6,398,777
Safety Label
Aperture Label
(Visible when aperture
cover is open)

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VenaCure 1470 Laser Operator Manual Page 17 Version 2.0
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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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 es Compliance Elec romagne ic emissions – guidance
RF emissions
C SPR 11 Group 1
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.
RF emissions
C SPR 11 Class B
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.
Harmonic emissions
EC 61000-3-2 Class A
Voltage fluctuations /
flicker emissions
EC 61000-3-3
Not applicable

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VenaCure 1470 Laser Operator Manual Page 19 Version 2.0
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.
Immuni y es IEC 60601 es level Compliance level Elec romagne ic environmen –
guidance
Electrostatic
discharge (ESD)
EC 61000-4-2
+/- 6kV contact
+/- 8kV air
+/- 6kV contact
+/- 8kV air
Floors should be wood, concrete or
ceramic tile. f floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient / burst
EC 61000-4-4
+/- 2kV for power
supply lines
+/- 1kV for input/output
lines
+/- 2kV for power
supply lines
+/- 1kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
EC 61000-4-5
+/- 1kV differential
mode
+/- 2kV common mode
+/- 1kV differential
mode
+/- 2kV common mode
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
EC 61000-4-11
<5% U
T
(>90% dip in U
T
)
for 0,5 cycle
40% U
T
(90% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
<5% U
T
(>90% dip in U
T
)
for 0,5 cycle
40% U
T
(90% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. f 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
(50/60 Hz)
EC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.

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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.
Immuni y es IEC 60601 es level Compliance
level
Elec romagne ic environmen - guidance
Conducted RF
EC 61000-4-6
Radiated RF
EC 61000-4-3
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2,5GHz
3Vrms
3V/m
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 separa ion dis ance.
d = 1.2 √P
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
determined by an electronic site survey,
a
should
be less than the compliance level in each
frequency range.
b
nterference 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. f 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. f 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.