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.

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TECHNICAL SPECIFICATIONS
Laser Type InGaAlP Laser Diode, CW
Wavelength 630nm ±3nm
Spectral Bandwidth ≥90% of optical power contained within 630nm ±3nm
Beam Output Profile 360-380µm diameter, 0.37 Numerical Aperture (NA) at
input to delivery fiber SMA
Power Maximum output to fiber port: 2660mW
Maximum power output to fiber tip (assuming minimum
fiber transmission 75%): 2000mW, limited by software
Minimum power output to fiber tip: 100mW
Output Power Stability ±1-2% typical, ±5% maximum (averaged over any one
second period) over 3200s (53min 20s)
Delivery Fiber Calibration 400mW for 2 seconds
Power
Aiming Beam InGaAlP (nominal wavelength 630nm) diode laser, ≤5mW
at delivery fiber tip. Modes: On/Off/Flash
Cooling Forced air
Power Supply 115 VAC ±10%, 60 Hz < 10A, single phase
or
230V VAC ±10%, 50Hz < 5A, single phase
(User selectable)
Delivery fiber Connector Standard SMA 905
Dimensions (H x W x D) 19 in x 8½in x 16 in (485mm x 220mm x 405mm) nominal
Weight 43lb (19.5kg) nominal
Environmental Ambient temp. 36°F to 122°F (2°C - 50°C) (storage)
Temperature 61°F to 86°F (16°C - 30°C) (operating)
Humidity <90%, RH non-condensing (storage)
<90%, RH non-condensing (operating)
Lifetime Diodes 500 hours at maximum rated power.
System 5 years.
Safety Standards EN 60601-1, EN 60601-1-2,EN 60601-2-22, EN 60825-1
21 CFR 1040.10, 1040.11, UL 60601-1

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SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS
The 630 PDT Laser is a Class IV laser product in compliance with EN 60601-1, EN 60601-1-2,
EN 60601-2-22, EN 60825-1, 21 CFR 1040.10, 21 CFR 1040.11 and UL 60601-1 and is
manufactured in compliance with 21 CFR 820.
The 630 PDT 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
A Class IV laser is hazardous to the eye from the direct beam and diffuse reflections.
It also presents significant skin and fire hazard.
Avoid eye or skin exposure to direct or scattered Laser Radiation. Take all
necessary protective measures in areas where the 630 PDT Laser is being used.
The 630 PDT Laser is a portable laser weighing 43lb. All standard safety procedures
for lifting should be applied when moving the instrument.
The use of an uninterruptible or back up power supply may be considered in order to
avoid cessation of treatment during a main power supply failure.
EYE INJURY
Visible light (630nm) from the 630 PDT Laser passes through the transparent
components of the eye and is focused on the retina at the back of eye. This light
can therefore cause an accidental retinal burn.
The Laser Safety Officer should review all procedures for safety.
ALL PERSONNEL MUST WEAR PROTECTIVE GLASSES APPROPRIATE TO
THE PROCEDURE TO ELIMINATE THE RISK OF EYE DAMAGE
When operating the 630 PDT Laser, ensure that the patients' eyes are fully
protected from possible laser exposure at all times.

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Eye Injury (continued)
All protective glasses should be designed for protection from laser radiation in the wavelength
range 625nm to 640nm. 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.
The recommendation of European Standards EN60825-1 or EN207 are appropriate to assess
laser eye risk. Note that the standards assume a viewing distance from the source of light of
more than 3.9 inches (100mm).
AngioDynamics can supply laser safety glasses in accordance with EN207.
The ‘Nominal Ocular Hazard Distance’ 6 feet (2 meters)
To protect against possible misdirected laser light from a bare ended optical fiber, at a distance
greater than 100mm, an OD >3 is suggested. Appropriate safety eyewear for this should be
labeled in accordance with EN207 as L3 or greater.
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.
BURNS
Accidental irradiation of any substance or material other than the target tissue may
result in a laser burn. Where anatomically possible, ensure that the area
surrounding the target tissue is protected appropriately.
REFLECTION WARNING
Avoid placing reflective materials such as glass, metals and polished plastic in the
path of the 630 PDT Laser beam.
EXPLOSION HAZARD WARNING
Do not use flammable or explosive anesthetic gases that may be ignited by the
630 PDT Laser. Avoid using other flammable or fume-emitting substances (e.g.
ether, iodine solution, collodion, and alcohol) in the operative field.

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SAFETY LABELING AND CONTROLS FOR THE 630 PDT LASER
FIGURE 1: FRONT PANEL & SIDE PANEL
FIGURE 2: REAR PANEL
Power Inlet Socket Power Switch Voltage Selector Potential Equalization Point
Laser Radiation Warning
Emergency
Stop Button
Refer to Operator manual
Laser Aperture Warning
Delivery
Fiber Port
Key Switch
Handswitch Socket
Remote Interlock Socket

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Product Identification Label – Located on the rear of the unit
Grounding Reliability Statement Label – Located on the rear of the unit
FIGURE 3: TOP PANEL
Calibration Port
Removable Inner
Cuvette Labeling
Handswitch
Socket
Fibres must be calibrated with
an internal cuvette in place
GROUNDI NG RE L I ABI L I T Y CAN ONL Y BE
ACHI EVEDWHENEQUI PMENT I S
CONNECT ED TOAN EQUI VAL ENT
RECEP TACL E MARKED ‘ HOSPI TAL
ONL Y ’ OR ‘ HOS PI TA L GRA DE ’

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SAFETY FEATURES OF THE 630 PDT Laser
The 630 PDT Laser includes a number of safety features that are provided in accordance with
the requirements of the appropriate standards. The 630 PDT Laser is built in compliance with:
European Harmonized Standards EN 60601-1, EN 60601-1-2, EN 60601-2-22 and EN 60825-1
USA Standards 21 CFR 1040.10, 1040.11 and UL 60601-1.
In order to comply, the 630 PDT Laser has the following standard safety features incorporated:
Protective housing
Remote interlock bypass (Figure 2)
Key control (Figure 1)
Laser radiation emission indicators:
!visible (STANDBY soft key text changes to READY and turns yellow in color)
!audible (beep)
READY and STANDBY modes
Manual reset mechanism
Shutter (not mechanical)
Fiber optic interlock
Emergency switch (Figure 1)
Warning labels (Figure 1)
Compliance label (Figure 2)
Aiming beam
The 630 PDT Laser is equipped with the following additional safety features:
Self test
Time out (automatic return to STANDBY mode)
Laser condition monitoring
Power diode watchdog
Microprocessor watchdog
Power fail protection
Power supply monitor
Temperature monitors
Session statistics

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Safety Features of the 630 PDT Laser (continued)
KEY SWITCH
(Figure 1)
The unit cannot be turned on without the key switch. It is recommended that the keys be
assigned to one or two key-holders that should make the keys available for scheduled
procedures only, thus preventing unauthorized use of the system.
REMOTE INTERLOCK
(Figure 2)
The system is provided with a remote interlock socket, which can be connected to a door switch.
If connected to a door switch this will automatically turn the system to STANDBY mode in the
event of the door being opened during the procedure.
If the remote interlock is connected to a door switch, then the cable used should be shielded
and the shield connected to the plug body. An EMC sleeve (ferrite tube) should also be fitted
over the cable adjacent to the connector. AngioDynamics can supply these on request. These
precautions will ensure that the possibility of electromagnetic emissions is minimized.

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DESCRIPTION OF THE 630 PDT LASER
Components
The 630 PDT Laser consists of two main components:
The main enclosure provides the housing for the 630 PDT Laser module containing all the
optics, heatsink, microprocessor based control electronics, integrating sphere and power
supplies.
The handswitch to activate the radiation when in READY mode.
Handswitch
The 630 PDT Laser is activated by a latching handswitch. The handswitch is in the OFF
position when the switch button is black. The handswitch is in the ON position when the switch
button is green. A single press and release of the button changes the state of the switch.
When switching the 630 PDT Laser on or switching to READYmode the handswitch should be
in the OFF position.
To activate the 630 PDT Laser, place the unit in READY mode and switch the handswitch to
ON. An audible tone indicates the emission of laser energy.
630 PDT Laser Latching Handswitch
630 PDT Laser emission is terminated when the handswitch is switched to the OFF position or
when the countdown has ended. In the latter case the handswitch must be returned to the OFF
position when the countdown has ended otherwise the 630 PDT Laser will display “Handswitch
Closed” when READY is reactivated. No further adjustment or use of the 630 PDT Laser will be
allowed until the handswitch is returned to OFF.

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FRONT PANEL
(Figure 1)
The main operating controls, apart from the power switch, for the 630 PDT Laser are located on
the front panel of the main enclosure.
Key Switch
The key switch (located on the front panel) provides the master control for the device. The key
is removable in the OFF position and the 630 PDT Laser is not operable when the key is
removed. The key switch activates the self-test program.
Emergency Switch
The emergency switch is the red button located on the front panel. Press to immediately
shutdown the 630 PDT Laser in case of emergency. After emergency activation the key switch
must be used to restart the system, otherwise the system will not return to READY mode.
Delivery Fiber Port
Located on the front panel of the system is an interlocked delivery fiber port with an SMA-905
connector for the delivery fiber.
All delivery fibers used with the 630 PDT Laser are coupled to the device by an
SMA-905 connector, attached to the proximal end of the delivery fiber. The output
power of every delivery fiber should be calibrated with the built in integrating sphere
power meter prior to use. See ‘Calibration’ section.

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REAR PANEL CONTROLS
(Figure 2)
The following sockets are located on the rear panel of the unit:
Power Switch
The power switch is located adjacent to the main power supply inlet on the rear panel.
Power Cord Socket
To connect an IEC power cord.
Remote Interlock
To connect the interlock cable connector. Otherwise fit the supplied remote interlock bypass.
Handswitch Port
To connect the handswitch cable connector.
Potential Equalization Point
To connect possible potential equalization line.
Voltage Selector
Voltage selector to set different power voltages.
Fuses
2 x T5A H 250V for 230/200V operation
2 x T10A H 250V for 115/100V operation
TOP PANEL
(Figure 3)
Calibration Port
Located on the top of the unit is the port to the AngioDynamics Integrating Sphere Power Meter
for delivery fiber calibration.