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.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.7 Version 2.2
Avoid directing the laser bea anywhere other than the treat ent area or
calibration ports.
Before using a fiber, check it carefully for any signs of da age during storage or
transit. Protective caps should be in place over SMA connectors. All screws and
ports should be secure. Do not use if there is any sign of da age.
The DELTA 15/30 Laser is a portable laser weighing 26lb. All standard safety
procedures for lifting should be applied when oving the instru ent.
There are no user serviceable parts in the DELTA 15/30 Laser. The exterior
cover should only be re oved by a trained and authorized laser service
technician.
Pins of connectors identified with the Electrostatic Discharge (ESD) warning
sy bol should not be touched. Connections should not be ade to these
connectors unless the ESD precautionary procedures detailed on page 2.20 are
followed.
It is reco ended that all staff receive an explanation of the ESD warning
sy bol and ade aware of the ESD precautionary procedures described at the
end of this section.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.8 Version 2.2
EYE INJURY
Extreme caution should be taken hen operating the DELTA 15/30 near
the eyes.
Near infrared light (810n ) fro the DELTA 15/30 passes through the
transparent co ponents of the eye and is focused on the retina at the back of
the eye. This light can therefore cause an accidental retinal burn.
All personnel ust wear approved protective glasses to reduce the risk of eye
da age. The patient should wear protective glasses when not anesthetized. If
the patient is anesthetized, the eyelids should be taped shut and covered with
oist gauze pads.
The local Laser Safety Officer should review all procedures for safety prior to
syste use.
All protective glasses should be designed for protection fro continuous wave
laser radiation in the wavelength range 790 – 830n .
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 establish ent.
The reco endations of European Standards EN 60825-1 or EN 207 are
appropriate to assessing laser eye risk. Note that the standards assu e a
viewing distance fro the source of light of ore than 100 (4 inches).
AngioDyna ics supplies laser safety glasses arked in accordance with EN
207 as L5 or greater. Contact your local AngioDyna ics representative if these
are required.
The ‘No inal Ocular Hazard Distance’ is 4.4 eters (14.5 feet).
Use of optical accessories and viewing aids, which ay increase the eye
exposure beyond a safe li it, should be subject to the approval of the Laser
Safety Officer.
Never look directly into the laser aperture even if earing safety glasses.
Serious eye injury could result.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.9 Version 2.2
BURNS
Irradiation of any substance or aterial other than the target tissue ay result in
a laser burn.
REFLECTION WARNING
Avoid placing reflective aterials such as glass, etals and polished plastic in
the bea .
EXPLOSION HAZARD WARNING
Avoid using fla able or explosive anesthetic gases that ay be ignited by the
laser. Avoid using other fla able or fu e-e itting substances (e.g. ether,
iodine solution, collodion, and alcohol) in the operative field.
VAPOR PLUME
AngioDyna ics reco ends that a s oke evacuator or in-line filter be used
when lasing.
Caution – Laser Plu e ay contain viable tissue particulates.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.10 Version 2.2
CLINICAL INDICATIONS & CONTRA-INDICATIONS
Indications The DELTA 15/30 is intended for the following contact or non-contact laser
procedures:
• Incision (only contact)
• Excision (only contact)
• Vaporization
• Coagulation / he ostasis
- of soft tissue in Endovascular, open and endoscopic procedures in Vascular
Surgery; General Surgery; Gynecology; Urology; Otorhinolaryngology
(ENT)/Head & Neck Surgery; Ophthal ology (oculoplastics);
Pul onology/Thoracic surgery; Plastic Surgery; Gastroenterology and
Neurosurgery.
Reco ended power levels for the above indications for contact fiber
accessories are between 5-30W and for non-contact fibers, 10-30W.
Beginning at low power (5-10W) with short pulse duration, the surgeon should
note the surgical effect and increase power or pulse duration until the desired
surgical effect is obtained.
Generally, the power require ent will vary depending on the contact fiber core
and tip size. Less power will be required to obtain tissue reaction with s aller
dia eter fibers. Reco ended power settings are less i portant than the visual
effect. Changes in tissue texture and color are the best indications of the laser
effect. Specific pulse duration is not reco ended, but is left to user preference
and best edical judg ent dependent on the particular application and tissue
type.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.11 Version 2.2
Contraindications The DELTA 15/30 should only be used in conditions where its use is
appropriate and of proven efficacy. It should never be operated except under the
direct supervision of a trained operator.
The potential for co plications encountered in surgical laser procedures will
be the sa e as those encountered in any surgical procedures. These
co plications ay be serious and could result in death.
Co plications ay include:
• Pain
• Fever and Leucocytosis
• Bleeding
• Sepsis
• Perforation
(This is not an exhaustive list.)
Potential co plications ay be encountered in laser procedures, particularly if
inappropriate Fluence settings are used.
Co plications in extre e cases ay include:
• Pain
• Perforation
• Ede a
• Erythe a
• Crusting
• Hyper-pig entation
• Hypo-pig entation
• Scarring
(This is not an exhaustive list.)

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.12 Version 2.2
CLINICAL WARNINGS
Diode laser radiation, like Nd:YAG laser radiation, penetrates significantly
deeper than CO
2
or argon ion lasers. Caution should be e ployed until the
biological interaction of the laser energy with tissue is fully understood by the
operator.
Tissue da age could occur if excessive Power/Fluence is used. Use low power
and short pulse duration settings until fully fa iliar with instru ent capabilities
and tissue response.
As with any conventional surgical operations, adverse reactions ay occur
following treat ent.
Use cautiously with patients who have had difficulty with previous laser
procedures.
The DELTA 15/30 should be used only on tissue that is fully observable. Do not
use the laser if the desired field is not visible, either directly or via an i aging
odality such as ultrasound.
Do not use coaxial gas/air coolant for non-contact fibers when there is a risk of
air/gas e bolis .
Do not use the laser close to large blood vessels or in highly vascularized areas,
except when these are the target for the laser treat ent.
When perfor ing endoscopic surgery it is vital for the surgeon to appreciate that
the view provided to the surgeon is onocular (not binocular) and depth
perception is decreased. Experience and training in laparoscopic techniques
are strongly reco ended prior to clinical use.
During ENT procedures, laser safe endotracheal tubes should be used.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.13 Version 2.2
CLINICAL PRECAUTIONS
Gene al P ecautions
Only operators who have been trained in the use of lasers and are thoroughly
fa iliar with this Operator Manual should use the DELTA 15/30. The infor ation
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 AngioDyna ics
representative for training aterials available on the use of this equip ent.
Although it is difficult to specify the effect that the use of the diode laser will have
in each therapeutic situation, it is possible to give a general overview as to what
the clinician ight expect when using the DELTA 15/30. The exact effect
depends upon the chosen procedure and, especially when using the laser with
anual settings, the Power/Fluence setting, Pulse Duration, Pulse Interval, Spot
size (if applicable) and the tissue type being treated.
The diode laser ay cause tissue da age if i properly used. Precautions, such
as careful assess ent of the target tissue during treat ent and the use of
appropriate Power/Fluence and Pulse Duration, should be taken. Use low
Power/Fluence and short Pulse Duration settings until fully fa iliar with the
instru ent’s capabilities.
Starting at low powers, the operator should note the effect on the tissue and
increase Power/Fluence, Pulse Duration or treat ent ti e until the desired effect
is obtained.
Specific para eters are not reco ended, but are left to operator preference
and best edical judg ent dependent on the particular application.
The diode laser ay not be effective for coagulation for severe he orrhages.
The operator ust be prepared to control he orrhages with strident, alternative
non-laser techniques. In contact surgery, the tissue interaction with the DELTA
15/30 laser is si ilar to Nd:YAG laser. In non-contact surgery the diode laser
wavelength, 810n , penetrates less in ost pig ented tissue types and blood
than the Nd:YAG laser wavelength.
P ecautions fo use with a handpiece
Starting at low powers, the operator should note the effect on the tissue and
increase Fluence or Pulse Duration until the desired effect is obtained.
The laser can cause epider al injury. The risk increases with greater laser
Fluence and skin pig entation.
Specific para eters are not reco ended, but are left to operator preference
and best edical judg ent dependent on the particular application.
It is strongly reco ended that the physician should carry out a s all, discrete
test patch at the chosen settings prior to undertaking full treat ent.
Extre e care should be taken when patients have a recently acquired sun tan, or
have a naturally dark skin color.

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.14 Version 2.2
SAFETY LABELING
Location of Safety Labeling
Safety labels for the DELTA 15/30 are positioned as indicated below.
P oduct Identification Labeling
Product identification labeling is located on the rear of the DELTA 15/30.
I0
100-240V
500VA 50-60Hz
2 x T6.3A
H 250V
0086
IOIOI
Made in the United Kingdom by:
AngioDynamics UK Ltd.
Building 2000, Beach Drive,
IQ Cambridge, Waterbeach,
Cambridge CB25 9TE
Distributed in the USA by
AngioDynamics Inc, NY 12804
This product complies ith
21 CFR 1040.10 and 1040.11, UL60601-1,
EN60601-1, 60601-2-22, 60825-1
IP21
This device contains an intentional radiator part nu ber
This product co plies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device ay not cause har ful interference, and
(2) this device ust accept any interference received,
including interference that ay cause undesired operation.
This device co plies with Canadian RSS-210
AS/0670
FCC ID: RBQAS0670
Canada IC: 4690A-AS0670
GROUNDING RELIABILITY CAN ONLY BE
ACHIEVED WHEN EQUIPMENT IS
CONNECTED TO AN EQUIVALENT
RECEPTACLE MARKED ‘HOSPITAL
ONLY’ OR ‘HOSPITAL GRADE’
PP/1149
US Patent no. 6,398,777
AngioDyna ics DELTA
Serial Nu ber: DELTA
Date of Manufacture:
DELTA 15
Safety Label
DELTA 30
Safety Label
Aperture Label
(visible when aperture
cover is open)

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.15 Version 2.2
SAFETY FEATURES
The DELTA 15/30 includes a nu ber of safety features, which are provided in
accordance with the require ents of the appropriate standards.
• protective housing
• re ote interlock bypass
• key switch
• laser radiation e ission indicator, visible and audible
• READY and STANDBY odes
• anual reset echanis
• shutter (not echanical)
• e ergency switch
• location of controls
• safety labels (see diagra )
• identification and co pliance label (see diagra )
• internal calibration port (optional on DELTA 15)
• calibration procedure for power easure ent
• ai ing bea
The DELTA 15/30 is equipped with the following additional safety features:
• self test
• laser condition onitoring
• pulse duration onitoring
• power diodes watch-dog
• icroprocessor watch-dog
• ains power fail protection
• power supply onitor
• te perature onitors

DELTA 15/30
DELTA 15/30 Operator Manual Page 2.16 Version 2.2
EMC DECLARATION
Guidance and manufactu e ’s decla ation – elect omagnetic emissions
The DELTA 15/30 is intended for use in the electro agnetic environ ent specified below.
The custo er or user of the DELTA 15/30 should ensure it is used in such an environ ent.
Emissions test Compliance Electromagnetic emissions – guidance
RF e issions
CISPR 11 Group 1
The DELTA 15/30 uses RF energy only for its internal
function. Therefore, its RF e issions are very low and are
not likely to cause any interference in nearby electronic
equip ent.
RF e issions
CISPR 11 Class B
Har onic e issions
IEC 61000-3-2 Class A
Voltage fluctuations /
flicker e issions
IEC 61000-3-3
Not applicable
The DELTA 15/30 is suitable for use in all establish ents,
including do estic establish ents and those directly
connected to the public low-voltage power supply network
that supplies buildings used for do estic purposes.