AngioDynamics DELTA 15 User manual

Manufactured in the United Kingdom by AngioDynamics UK Limited
AngioDynamics is a Registered Trademark of AngioDynamics Inc.
EVLT is a Registered Trademark of AngioDynamics Inc.
 010 AngioDynamics UK Ltd.
DELTA 15/30
DIODE LASER
OPERATOR MANUAL
Version . March 010 MAN/ 6/0068 US

DELTA 15/30
DELTA 15/30 Operator Manual Page 1. Version .
SECTION 1 WELCOME
Thank you for purchasing an AngioDynamics 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 1.4 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 DELTA 15 and the DELTA 30 (referred to as DELTA 15/30
in this manual). These lasers are 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 ) and the Operating
Instructions (section 3).
The operator must become amiliar with all the controls be ore commencing any therapy.
DELTA 15 The DELTA 15 is a diode laser capable of delivering up to 15W of continuous wave
radiation via an optical fiber, or 119J/cm² of pulsed radiation via a spot handpiece,
coupled to the laser aperture.
The DELTA 15 incorporates a Class IV GaAlAs (Gallium Aluminium Arsenide) diode
laser with a wavelength of 810nm (± 0nm).
The DELTA 15 incorporates a visible Class IIIa diode laser aiming beam with a
wavelength of 635-660nm and a maximum power output of 5mW.
DELTA 30 The DELTA 30 is a diode laser capable of delivering up to 30W of continuous wave
radiation via an optical fiber, or 6J/cm² of pulsed radiation via a spot handpiece,
coupled to the laser aperture.
The DELTA 30 incorporates a Class IV GaAlAs (Gallium Aluminum Arsenide) diode
laser with a wavelength of 810nm (± 0nm).
The DELTA 30 incorporates a visible Class IIIa diode laser aiming beam with a
wavelength of 635-660nm and a maximum power output of 5mW.

DELTA 15/30
DELTA 15/30 Operator Manual Page 1.3 Version .
DESCRIPTION OF THE DELTA 15/30
The DELTA 15/30 has been designed for use with the AngioDynamics range of procedure kits, such as
those for EVLT
®
(EndoVenous Laser Treatment). It can also be used with a wide range of standard
fibers and accessories, further details of which are in section 4 of this manual.
The DELTA 15/30 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 or handpiece for delivering the laser radiation to the tissue
Key features of the DELTA 15/30 include:
• 15W or 30W power output
• Compact & portable
• Intuitive user interface
• Automatic fiber recognition when used with fibers and accessories conforming to the
AngioDynamics Fiber Recognition System (FRS)
• Minimal maintenance & service
• Internal power calibration meter (optional on DELTA 15)
• Memory card slot for transfer of data between the DELTA 15/30 and a PC
ABOUT THIS MANUAL
This manual is broken down into six main sections as described below. The contents of each one are
detailed at the beginning of the appropriate section.
1 Welcome
Safety & Warnings Explains the general warnings and precautions that must be followed to
ensure that the DELTA 15/30 is used in a safe manner.
3 Operating Instructions Detailed instructions on how to install and operate the DELTA 15/30
laser.
4 Procedures Specific information about AngioDynamics fibers and procedure kits,
equipped with FRS.
5 Technical Information This section explains all the maintenance procedures that can be
performed by the user.
6 Warranty Contains the AngioDynamics warranty policy.

DELTA 15/30
DELTA 15/30 Operator Manual Page 1.4 Version .
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:

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.1 Version 2.2
SECTION 2 SAFETY & WARNINGS
CONTENTS
Sy bols used in this Manual ................................................................................................................ 2.2
Sy bols used on AngioDyna ics products ......................................................................................... 2.3
Warnings............................................................................................................................................... 2.4
EMC Warning........................................................................................................................................ 2.5
Safety Classifications, Hazards and Precautions................................................................................. 2.6
Eye Injury.............................................................................................................................................. 2.8
Burns..................................................................................................................................................... 2.9
Reflection Warning................................................................................................................................ 2.9
Explosion Hazard Warning ................................................................................................................... 2.9
Vapor Plu e ......................................................................................................................................... 2.9
Clinical Indications & Contra-Indications ............................................................................................ 2.10
Clinical Warnings ................................................................................................................................ 2.12
Clinical Precautions ............................................................................................................................ 2.13
Safety Labeling ................................................................................................................................... 2.14
Safety Features................................................................................................................................... 2.15
EMC Declaration................................................................................................................................. 2.16
ESD Precautionary Procedures.......................................................................................................... 2.20
Essential Perfor ance........................................................................................................................ 2.20
FCC Declaration ................................................................................................................................. 2.20

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.2 Version 2.2
SYMBOLS USED IN THIS MANUAL
This sy bol indicates caution should be taken, as there ay be a potentially
hazardous situation that could result in injury to personnel or da age to the
equip ent.
This sy bol indicates the possibility of a non-radiation hazard that ay result in severe
injury to personnel within the vicinity of the equip ent.
This sy bol indicates the possibility of an electrical hazard that could cause injury to
personnel within the vicinity of the equip ent or da age to the equip ent.
This sy bol indicates the possibility of exposure to hazardous laser radiation that
could cause injury to personnel within the vicinity of the equip ent.
This sy bol indicates personnel within the vicinity of the equip ent should wear
appropriate eye protection.
This sy bol indicates an i portant point to be noted.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.3 Version 2.2
SYMBOLS USED ON ANGIODYNAMICS PRODUCTS
The following sy bols are used on the DELTA 15/30 laser and on accessories provided by
AngioDyna ics.
Consult instructions for use
Caution, consult acco panying docu ents
Power Off
Power Off (only for a part of equip ent)
Power On
Type B applied part
Intentional radiator
The co ponent or accessory is non-sterile
Do not re-use
Do not use if packaging is da aged
Expiration date
Batch nu ber
Product re-order code
Sterile by Ethylene Oxide

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.4 Version 2.2
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 fa iliar with laser procedures.
Use of controls or adjust ents or perfor ance of procedures other than those
specified herein ay result in hazardous radiation exposure.
This product ust be stored at te peratures between 32°F and 130°F. If stored at
te peratures outside these li its for a period of ti e, the laser requires up to 12
hours to accli atize, prior to operation.
Failure to observe this could result in invalidation of the warranty.
If the product has been stored at a te perature above 86°F, the laser’s cooling
syste ay take a few inutes to stabilize after it has been switched on.
A essage will be displayed on the screen to indicate this.
The laser is not designed to operate at te peratures below 50°F.
The Optical Power Calibration eter, if fitted, is to be used only to calibrate a fiber or
spot handpiece in accordance with the instructions detailed in this anual.
Under no circu stances ay it be used as a bea du p, as this will result in
da age to the instru ent.
This product contains a lithiu battery, which should only be replaced by authorized
service personnel.
Replace the battery only with the sa e or equivalent type. Dispose of used batteries
according to the anufacturer’s instructions and local disposal require ents.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.5 Version 2.2
EMC WARNING
Medical electrical equip ent needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC infor ation provided.
The DELTA 15/30 ay be interfered with by other equip ent, even if that other equip ent co plies
with CISPR e ission require ents.
Portable and Mobile RF co unications equip ent can affect edical electrical equip ent.
The DELTA 15/30 should not be used adjacent to or stacked with other equip ent. If adjacent or
stacked use is necessary, the DELTA 15/30 should be observed to verify nor al operation in the
configuration in which it will be used.
If Electro agnetic interference is experienced, relocate or re-orientate the DELTA 15/30 or the other
equip ent.
Accessories, transducers and cables other than those specified, with the exception of
transducers and cables sold by the anufacturer of the DELTA 15/30 as replace ent parts for
internal co ponents, ay result in increased e issions or decreased i unity of the DELTA
15/30. ‘I unity’ is the ability of a device to function nor ally when operated in the presence
of electro agnetic radiation.
The following cables are co patible with the DELTA 15/30 :
• Foot Switch Asse bly (supplied with laser):
AngioDyna ics part nu ber: AS1/A0/0002.
• Re ote Interlock Lead (if required):
Le o connector (supplied with laser): AngioDyna ics part no. CON/51/0003
Ferrite sleeve (Farnell part no. 898-454).
Screened twisted pair cable 7/0.2 (Farnell part no. 140-457), axi u length 4 (13 feet).
Note: The ferrite sleeve should be fitted to the re ote interlock cable, at a axi u of 75
(3 inches) fro the Le o connector.
• Re ote Interlock Bypass (supplied with laser):
AngioDyna ics part nu ber: AS1/A3/0024.
• IEC Power Lead (supplied with laser):
AngioDyna ics part nu bers CBL/02/0040.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.6 Version 2.2
SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS
The DELTA 15/30 is classified as a Class IV laser product in co pliance 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 DELTA 15/30 confor s to the require ents of Council Directive 93/42/EEC
of the Council of European Co unities (Medical Devices Directive). Affixing the
‘CE Mark’ to the instru ent indicates confor ity to this directive.
0086
The local Laser Safety Officer should review all procedures for safety prior to
syste use.
A Class IV Laser is hazardous to the eye fro the direct bea and diffuse
reflections. It also presents significant skin and fire hazard.
Avoid eye or skin (except specific treat ent) exposure to direct or scattered
radiation. Take all necessary protective easures, as explained in the rest of this
section, in areas where the laser is being used.
All personnel ust wear approved protective glasses appropriate to the
wavelength of the DELTA 15/30 to reduce the risk of eye da age.
The ai ing bea is a Class IIIa Laser and an unprotected eye ay view the
bea scattered fro a non-reflective surface. Do not stare into the ai ing bea
or view it directly with optical instru ents.