AngioDynamics 630 PDT User manual

MAN/08/0020 US Page 1 Version 6.0
630 PDT Laser
FOR PHOTODYNAMIC THERAPY
Model T2USA
Operator's Manual
Version 6.0 US
May 2009
AngioDynamics Inc
603 Queensbury Ave.
Queensbury, NY 12804
Customer Service Tel: [phone]
Laser Service Tel: [phone]
Fax: [phone]
Email: [e-mail]
http://www.angiodynamics.com
630 PDT Laser is manufactured in the United Kingdom by:
AngioDynamics UK Limited
Building 2000, Beach Drive
IQ Cambridge, Waterbeach
Cambridge CB25 9TE
United Kingdom
Tel: [phone]
Fax: [phone]
Email: [e-mail]
AngioDynamics is a Registered Trademark of AngioDynamics Inc.

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PRODUCT INFORMATION
630 PDT Laser serial number ____________________________________________________
Software versions
Main Program ____________________________________________________________
Display Program __________________________________________________________
[Note: This information is displayed on the ‘Statistics’ screen of the 630 PDT Laser]
Date Installed _________________________________________________________________
Installed by
Signed __________________________________________________________________
Print Name ______________________________________________________________
Organization _____________________________________________________________
For service, parts or repair contact your local AngioDynamics Representative:

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CONTENTS
SYMBOLS USED IN THIS MANUAL ............................................................................................6
WARNINGS...................................................................................................................................7
EMC WARNING ............................................................................................................................8
INTRODUCTION...........................................................................................................................9
CLINICAL INDICATIONS ..............................................................................................................9
Precaution ...............................................................................................................................10
TECHNICAL SPECIFICATIONS .................................................................................................11
SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS...............................................12
EYE INJURY ...............................................................................................................................12
BURNS........................................................................................................................................13
REFLECTION WARNING ...........................................................................................................13
EXPLOSION HAZARD WARNING .............................................................................................13
SAFETY LABELING AND CONTROLS FOR THE 630 PDT LASER .........................................14
FIGURE 1: FRONT PANEL & SIDE PANEL ...........................................................................14
FIGURE 2: REAR PANEL .......................................................................................................14
FIGURE 3: TOP PANEL..........................................................................................................15
SAFETY FEATURES OF THE 630 PDT Laser...........................................................................16
KEY SWITCH ..............................................................................................................................17
REMOTE INTERLOCK ...............................................................................................................17
DESCRIPTION OF THE 630 PDT LASER..................................................................................18
Components ............................................................................................................................18
Handswitch..............................................................................................................................18
FRONT PANEL ...........................................................................................................................19
Key Switch...............................................................................................................................19
Emergency Switch...................................................................................................................19
Delivery Fiber Port...................................................................................................................19
REAR PANEL CONTROLS.........................................................................................................20
Power Switch...........................................................................................................................20
Power Cord Socket .................................................................................................................20
Remote Interlock .....................................................................................................................20
Handswitch Port ......................................................................................................................20
Potential Equalization Point.....................................................................................................20
Voltage Selector ......................................................................................................................20
Fuses.......................................................................................................................................20
TOP PANEL ................................................................................................................................20
Calibration Port........................................................................................................................20
INSTALLATION...........................................................................................................................21

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Inspection ................................................................................................................................21
Components ............................................................................................................................21
Installing the 630 PDT Laser ...................................................................................................21
TOUCH-SCREEN CONTROLS ..................................................................................................23
START.........................................................................................................................................23
MAIN MENU................................................................................................................................23
TREATMENT MODES ................................................................................................................24
CALIBRATION ............................................................................................................................24
Displayed Power Output..........................................................................................................26
DIFFUSER SETTINGS MODE....................................................................................................27
CUSTOM SETTINGS MODE ......................................................................................................30
SET UP MENU............................................................................................................................33
AIMING BEAM MODE.................................................................................................................34
SESSION STATISTICS...............................................................................................................35
ENGINEER MODE......................................................................................................................36
FAULTS SCREEN.......................................................................................................................37
FAULT MESSAGES....................................................................................................................38
Remote Interlock .....................................................................................................................38
Emergency Switch Pressed: Use Key Switch to Reset...........................................................38
Setting the Wavelength ...........................................................................................................38
Handswitch Not Connected.....................................................................................................38
High Temperature Warning .....................................................................................................38
Temperature Too High ............................................................................................................38
Handswitch Failure..................................................................................................................39
Handswitch On ........................................................................................................................39
Call Service Engineer..............................................................................................................39
OPERATING INSTRUCTIONS ...................................................................................................40
INTEGRATING SPHERE ............................................................................................................42
Outer (fixed) Cuvette...............................................................................................................42
Inner (removable) Cuvette.......................................................................................................42
Cleaning the cuvettes..............................................................................................................42
Sterilizing the Inner (removable) Cuvette ................................................................................42
MAINTENANCE ..........................................................................................................................43
Cleaning ..................................................................................................................................43
DISPOSAL OF PRODUCT..........................................................................................................43
LASER POWER OUTPUT ..........................................................................................................43
MEASUREMENT SYSTEM CALIBRATION................................................................................44
CALIBRATING THE INTERNAL INTEGRATING SPHERE POWER METER............................44
POWER OUTPUT ADJUSTMENTS ...........................................................................................44
MANUFACTURER’S GUARANTEE POLICY .............................................................................45

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GUARANTEE CLAIMS................................................................................................................45
APPENDIX ..................................................................................................................................46
ADJUSTING THE CALIBRATION OF THE INTERNAL INTEGRATING SPHERE POWER METER
....................................................................................................................................................46
Introduction..............................................................................................................................46
Equipment Required................................................................................................................46
Procedure................................................................................................................................46
INTERNAL POWER METER CALIBRATION RESULTS SHEET...............................................47
CALIBRATING THE MEASUREMENT SYSTEM – POWER OUTPUT ADJUSTMENTS ..........48
EMC DECLARATION..................................................................................................................50
12 MONTH MANUFACTURER’S GUARANTEE REGISTRATION CERTIFICATE....................55
12 MONTH MANUFACTURER’S GUARANTEE REGISTRATION FORM.................................57

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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.
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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WARNINGS
The 630 PDT Laser is intended for use only by trained physicians.
Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician.
Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous Laser Radiation exposure.
It is strongly recommended that the 630 PDT Laser should be stored at
temperatures between 36°F and 122°F (2°C - 50°C). Failure to observe this
could result in invalidation of the warranty. If stored at temperatures out of
this range for a period of time, the 630 PDT Laser requires up to 6 hours to
acclimatize prior to operation.
Operating temperature should be between 61°F and 86°F (16°C - 30°C) or
the 630PDT will not function.

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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 630 PDT 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 630 PDT Laser should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary, the 630 PDT 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 630 PDT
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 630 PDT Laser as replacement
parts for internal components, may result in increased emissions or decreased immunity
of the 630 PDT 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 630 PDT Laser:
•Hand Switch Assembly
AngioDynamics part no. AS/246 (supplied with laser)
•Remote Interlock Lead (if required).
Lemo connector (supplied with laser): AngioDynamics part no. CON/51/0003
Ferrite sleeve (Farnell part no. 898-454).
Screened twisted pair cable 7/0.2 (Farnell part no. 140-457).
Note: The ferrite sleeve should be fitted to the remote interlock cable, at a maximum of
75 mm from the Lemo connector.
•Remote Interlock Shorting Plug (supplied with laser).
AngioDynamics part no. AS1/A3/0024
•IEC Mains Lead (supplied with Laser)
AngioDynamics part numbers: CBL/02/0002, CBL/02/0040, CBL/02/0042, CBL/02/0046,
CBL/02/0051, CBL/02/0063.

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INTRODUCTION
This manual describes the operation of the 630 PDT Laser Model T2USA, which is to be used
only by experienced, trained surgeons/physicians familiar with laser procedures and
photodynamic therapy. Throughout this manual the 630 PDT Laser Model T2USA will be
described as the 630 PDT Laser.
The 630 PDT Laser is a diode laser for photodynamic therapy (PDT) providing 2000 mW of
continuous wave Laser Radiation to the tip of a delivery fiber. The 630 PDT Laser is a Class IV
InGaAlP diode laser with a nominal wavelength of 630nm ±3nm.
Before using this instrument for the first time, read the Safety Requirements and Operating
Instructions outlined in this manual.
It is strongly recommended that the operator becomes familiar with all the controls before
commencing any therapy.
CLINICAL INDICATIONS
The 630 PDT Laser is intended for use in photodynamic therapy (PDT) as a source for the
photoactivation of PHOTOFRIN(porfimer sodium) for Injection for:
•palliation of patients with completely obstructing esophageal cancer, or of patients with
partially obstructing esophageal cancer who, in the opinion of their physician, cannot be
satisfactorily treated with Nd:YAG laser therapy;
•reduction of obstruction and palliation of symptoms in patients with completely or
partially obstructing endobronchial nonsmall cell lung cancer (NSCLC); and
•treatment of microinvasive endobronchial NSCLC in patients for whom surgery and
radiotherapy are not indicated.
Warnings and Precautions
Adverse effects of the AngioDynamics 630 PDT Laser could be related to inappropriate laser
powers or improper use. Such situations should not occur if the conditions and instructions for use,
as fully described in the PHOTOFRINand OPTIGUIDETM Fiber Optic Diffuser Package Inserts,
are followed.
Use of incompatible Lasers or delivery fibers that alter the required output characteristics of light for
the photoactivation of PHOTOFRINcould result in incomplete treatment due to partial
photoactivation of PHOTOFRIN, overtreatment due to over activation of PHOTOFRIN, damage
to surrounding normal tissue, and/or damage to the fiber optic diffuser which could additionally
create an optical hazard for medical personnel and/or patients.

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Clinical Indications (continued)
Adverse Effects of the Device on Health
If the laser power drops so that the light dose delivered to tissue is below that needed to activate
PHOTOFRIN, the treatment will fail. If the power is greater than expected, so that an excess
light dose is delivered to tissue, then some areas of adjacent normal tissue that should have
been spared treatment could be damaged by the PDT effect. At very high laser power levels,
greater than the OPTIGUIDETM Fiber Optic Diffuser rated value, there is a risk of damaging the
OPTIGUIDETM Fiber Optic Diffuser, which could cause non-uniform output, heating of the
diffusing tip and eventual tip destruction. The inclusion of the built-in integrating sphere power
meter is intended to reduce these possible events.
Refer to the PHOTOFRINpackage insert for information and instructions for use of the drug.
Refer to OPTIGUIDETM package insert for information and instructions for use of the delivery
fiber, information on laser power, duration and light dose.
PHOTOFRINis a registered trademark of Axcan Pharma Inc.
OPTIGUIDETM is a trademark or registered trademark owned or licensed by QLT
PhotoTherapeutics Inc.
Precaution
Only use AngioDynamics labeled or AngioDynamics approved fibers with the
AngioDynamics 630 PDT Laser. Use of unapproved fibers may cause injury,
ineffectual treatment or damage to the 630 PDT Laser. Damage caused using
unapproved fibers may invalidate the product guarantee.