Operators Manual
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DIOMED SURGICAL Operator Manual Version 7.0 Dec 2004
DIOMED 15 DIOMED 30 DIOMED 60
US Federal Law restricts this device to sale by or on the order of a physician
MAN/14/0043 US
Surgical Diode Laser
DIOMED SURGICAL DIODE LASER Models: DIOMED 60, DIOMED 30 & DIOMED 15
OPERATOR MANUAL Version 7.0 US English December 2004
USA DIOMED Inc. One Dundee Park Suite 5 Andover MA 01810 USA
UK DIOMED Ltd. Building 2000, Beach Drive Cambridge Research Park Waterbeach Cambridge CB5 9TE United Kingdom
Tel: 1 866 883 8820 Fax: 1 978 475 8488 Email: [email protected]
Tel: + 44 1223 729 372 Fax: + 44 1223 729 320 E-mail: [email protected] http://www.diomedinc.com
Manufactured in the United Kingdom by DIOMED Limited DIOMED is a Registered Trademark of DIOMED Ltd.
MAN / 14 / 0043US
2004 Diomed Inc.
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Surgical Diode Laser
PRODUCT INFORMATION
Laser Serial Number _________________________________
Software Version ____________________________________ Date Installed _______________________________________ Installed by Signed ____________________________________________ Print Name _________________________________________ Organization________________________________________
For service, parts or repair contact your local representative:
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Surgical Diode Laser
CONTENTS PRODUCT INFORMATION ... 3 CONTENTS ... 4 SYMBOLS USED IN THIS MANUAL... 6 WARNINGS ... 7 INTRODUCTION ... 8 TECHNICAL SPECIFICATIONS DIOMED 60 ... 9 TECHNICAL SPECIFICATIONS DIOMED 30 ... 10 TECHNICAL SPECIFICATIONS DIOMED 15 ... 11 SAFETY ... 12 Safety Classifications, Hazards and Precautions ... 12 LOCATION OF SAFETY LABELING FOR THE DIOMED SURGICAL LASERS... 14 SAFETY FEATURES... 15 Key Switch ... 16 Remote Interlock... 16 Remote Interlock Bypass ... 16 DESCRIPTION OF DIOMED SURGICAL LASER... 17 Location of Controls on the Diomed Surgical Laser ... 17 FRONT PANEL ... 18 Menu Select ... 19 SIDE PANEL ... 19 Calibration Port ... 19 Laser Aperture... 19 REAR PANEL... 20 INSTALLATION ... 21 Inspection ... 21 Components ... 21 INSTALLING THE DIOMED SURGICAL LASER... 22 MENUS ... 23 Main Menu (Default Menu)... 24 System Setup Menu... 25 Aiming Intensity... 26 Aiming Mode ... 27 Set Clock... 28 Audible Volume Adjustment ... 29 Audible pitch adjustment ... 30
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Surgical Diode Laser Display Contrast Adjustment ...31 Engineer Mode...32 Countdown Mode ...33 Session Statistics ...34 Calibration (Not available on the Diomed 15) ...35 Transmission Acceptability ...37 Interlock (Fault) Messages ...38 OPERATING INSTRUCTIONS...41 CLINICAL INSTRUCTIONS ...43 General Precautions ...43 INDICATIONS ...45 CONTRAINDICATIONS ...45 COMPLICATIONS...46 INDICATIONS ...47 Contraindications...47 Potential Complications...47 ACCESSORIES ...48 Optical Fibers ...48 PRE-CARBONIZATION PROCEDURE ...49 STERILIZATION...50 Optical Fibers ...50 MAINTENANCE & CALIBRATION...51 Cleaning...51 Calibrating the Internal Power Meter ...51 Disposal of Product ...51 POWER CALIBRATION ...52 Calibration of the Measurement System Controlling Laser Power Output...52 Power Output Adjustments...52 WARRANTY POLICY...53 APPENDIX A – CALIBRATING THE INTERNAL POWER METER ...54 Calibrating the internal power meter...54 Equipment required...54 Procedure...54 APPENDIX B – POWER OUTPUT ADJUSTMENT...59 Diode Set Up ...59 APPENDIX C - EMC DECLARATION...61 APPENDIX D - ESD PRECAUTIONARY PROCEDURES ...65
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Surgical Diode Laser
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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Surgical Diode Laser
WARNINGS
WARNING
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. The Diomed Surgical Laser should not be stored at temperatures of below -5°C. Failure to observe this could result in invalidation of the warranty. 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 Diomed Surgical 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 Diomed Surgical Laser should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Diomed Surgical 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 Diomed Surgical 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 Diomed Surgical Laser as replacement parts for internal components, may result in increased emissions or decreased immunity of the Diomed Surgical 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 Diomed Surgical Laser: •
Foot Switch Assembly Diomed part no. AS1/A0/0002 (supplied with laser)
•
Remote Interlock Lead (if required). Lemo connector (supplied with laser): Diomed 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). Diomed part no. AS1/A3/0024
•
IEC Mains Lead (supplied with Laser) Diomed part numbers: CBL/02/0002, CBL/02/0040, CBL/02/0042, CBL/02/0046, CBL/02/0051, CBL/02/0063.
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Surgical Diode Laser
INTRODUCTION The Diomed Surgical Laser The Diomed Surgical Laser is a surgical diode laser delivering 60 Watts, 30 Watts or 15 Watts (depending upon the model) of continuous wave laser radiation. The laser energy is delivered to the treatment site by means of a flexible optical fiber coupled to the laser aperture. The Diomed Surgical Laser incorporates Class IV GaAlAs (Gallium Aluminum Arsenide) diode lasers with wavelengths in the range 790-830 nm and a visible (aiming beam) 4 mW Class IIIa diode laser with wavelength in the range 635-660 nm. There are three models within the range of Diomed Surgical Lasers: • Diomed 60 • Diomed 30 • Diomed 15 This manual illustrates the operation of the range of Diomed Surgical Lasers, which are intended for use only by trained surgeons familiar with laser procedures. Before using this instrument for the first time, read the Safety Requirements, Operating Instructions and Clinical Instructions outlined in this manual.
It is strongly recommended that the operator becomes familiar with all the controls before commencing any surgery.
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Surgical Diode Laser
TECHNICAL SPECIFICATIONS DIOMED 60 Laser Type
GaAlAs Laser Diode
Wavelength
810 nm ± 20 nm
Power Output to Laser Aperture
0.5 - 60W
Treatment Modes
Continuous, pulse, repeat pulse and countdown
Pulse Duration
0.1 - 9.9 seconds
Repeat Mode
0.1 - 1.0 second pulse duration, 0.1 - 1.0 second interval
Countdown
10 - 3200 seconds
Calibration
Power meter for automatic fiber calibration
Aiming Beam
Visible laser diode 635-660nm, nominally 4mW at laser aperture continuous or intermittent
Cooling
Forced air
Power Supply
230/115VAC ± 15% 500VA
50, 60 Hz ± 5%
Dimensions (H x W x D)
6.89 x 15.35 x 15.24 inches (nominal)
Weight
35.2lb maximum
Fibers (contact)
600µm and 1000µm contact fibers
Fibers (non-contact)
600µm and 1000µm fibers with or without gas/fluid assist
Fiber Connector
Standard SMA 905
Safety Standards
EN 60601-1, EN 60601-1-2, EN 60601-2-22, EN 60825-1 21CFR 1040.10 & 1040.11
IMPORTANT DO NOT USE 400µm core fibers with the Diomed 60 surgical laser. This will damage the laser.
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Surgical Diode Laser
TECHNICAL SPECIFICATIONS DIOMED 30 Laser Type
GaAlAs Laser Diode
Wavelength
810 nm ± 20 nm
Power Output to Fiber Laser Aperture
0.5 - 30W
Treatment Modes
Continuous, pulse, repeat pulse and countdown
Pulse Duration
0.1 - 9.9 seconds
Repeat Mode
0.1 - 1.0 second pulse duration, 0.1 - 1.0 second interval
Countdown
10 - 3200 seconds
Calibration
Power meter for automatic fiber calibration
Aiming Beam
Visible laser diode 635-660nm, nominally 4mW at laser aperture continuous or intermittent
Cooling
Forced air
Power Supply
100V, 120V, 220V, 240V ± 10% or 110V, 130V, 230V, 250V ±10% 220VA 50, 60 Hz ±5%
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Dimensions (H x W x D)
6.89 x 15.35 x 15.24 inches (nominal)
Weight
26.46lb maximum
Fibers (contact)
400µm, 600µm and 1000µm contact fibers
Fibers (non-contact)
600µm and 1000µm fibers with or without gas/fluid assist
Fiber Connector
Standard SMA 905
Safety Standards
EN 60601-1, EN 60601-1-2, EN 60601-2-22, EN 60825-1 21CFR 1040.10 & 1040.11
Surgical Diode Laser
TECHNICAL SPECIFICATIONS DIOMED 15 Laser Type
GaAlAs Laser Diode
Wavelength
810 nm ± 20 nm
Power Output to Laser Aperture
0.5 - 15W
Treatment Modes
Continuous, pulse, repeat pulse and countdown
Pulse Duration
0.1 - 9.9 seconds
Repeat Mode
0.1 - 1.0 second pulse duration, 0.1 - 1.0 second interval
Countdown
10 - 3200 seconds
Aiming Beam
Visible laser diode 635-660nm, nominally 4mW at laser aperture continuous or intermittent
Cooling
Forced air
Power Supply
100V, 120V, 220V, 240V ± 10% or 110V, 130V, 230V, 250V ±10% 125VA 50, 60 Hz ±5%
Dimensions (H x W x D)
6.89 x 15.35 x 15.24 inches (nominal)
Weight
26.46lb maximum
Fibers (contact)
400µm, 600µm and 1000µm contact fibers
Fiber Connector
Standard SMA 905
Safety Standards
EN 60601-1, EN60601-1-2, EN 60601-2-22, EN60825-1 21CFR 1040.10 & 1040.11
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Surgical Diode Laser
SAFETY Safety Classifications, Hazards and Precautions The Diomed Surgical Laser is classified as a Class IV laser product in compliance with FDA 21 CFR 1040.10 and 1040.11, EN 60601-1, EN 60601-1-2, EN 60601-2-22 and EN 60825-1. The Diomed Surgical Laser conforms to the requirements of Council Directive 93/42/EEC of the Council of the European Communities (Medical Device Directive). Affixing the ‘CE Mark’ (shown below) to the instrument indicates conformity to this Directive.
0086 CAUTION 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 (except specific treatment) exposure to direct or scattered radiation. Take all necessary protective measures in areas where the laser is being used. ALL PERSONNEL MUST WEAR PROTECTIVE GLASSES APPROPRIATE TO THE WAVELENGTH OF THE DIOMED SURGICAL LASER TO REDUCE THE RISK OF EYE DAMAGE. The aiming beam is a Class IIIa laser and an unprotected eye may view the beam scattered from a non-reflective surface. Do not stare into aiming beam or view it directly with optical instruments.
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Surgical Diode Laser
SAFETY (continued) Eye Safety
All protective glasses should be designed for protection from continuous wave laser radiation in the wavelength range 790830nm (Gallium Aluminum Arsenide (GaAlAs) diode laser). The degree of optical filtration (optical density or OD) depends on the application and should be assessed and approved by the appointed laser safety officer for the establishment. The recommendations of European standards EN 60825-1 or EN 207 are appropriate to assessing laser eye risk. Note that the standards assume a viewing distance from the source of light of more than 100mm (4 inches). DIOMED can supply laser safety glasses marked in accordance with EN 207. Please contact your local representative if these are required. For applications using bare fiber tips at greater than 100mm (4 inches) viewing distance, an OD > 4 is suggested. Appropriate safety eyewear for this should be marked in accordance with EN 207 as L4 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
Irradiation to any substance or material other than the target tissue may result in a laser burn. Surrounding the target area with moist drapes or saline-soaked gauze pads and keeping them moist will greatly reduce this hazard. Be sure that the draping is appropriate for laser surgery.
Vapor Plume
DIOMED recommends that a smoke evacuator or in-line filter be used to capture the plume whenever possible and that the operating room personnel regard the plume as a source of active biological material.
Reflection Hazard
AVOID placing reflective materials such as glass, metals and polished plastic in the laser beam
Explosion Hazard
Avoid using flammable or explosive anesthetic gases that may be ignited by the laser. Avoid using other flammable or fume-emitting substances (e.g. ether, iodine solution, collodion, and alcohol) in the operative field.
Pins of connectors identified with the Electrostatic Discharge (ESD) warning symbol should not be touched. Connections should not be made to these connectors unless the ESD precautionary procedures detailed in Appendix D are followed. It is recommended that all staff receive an explanation of the ESD warning symbol and are made aware of the ESD precautionary procedures in Appendix D.
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Surgical Diode Laser
LOCATION OF SAFETY LABELING FOR THE DIOMED SURGICAL LASERS Warning labels and Serial Number labels are model dependent. FIGURE 1:
Diomed 15
Diomed 30
Diomed 60
ATTENTION SEE INSTRUCTIONS FOR USE
STOP
PP/0299 Iss2
EN 60601-2-22 : 1996
LASER APERTURE at distal end of the optical fiber A3/PP1/0051 Iss2
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Surgical Diode Laser
SAFETY FEATURES The Diomed Surgical Laser includes a number of safety features that are provided in accordance with the requirements of the appropriate standards. The Diomed Surgical Laser is built in compliance with: • European Harmonized Standard EN 60601-1, EN 60601-1-2, EN 60601-2-22 and EN 60825-1. • USA Standards 21 CFR 1040.10 and 1040.11 and has the following standard safety features required to comply with these standards: • protective housing • remote interlock connector • key switch • laser radiation emission indicator, visible and audible • READY and STANDBY modes • manual reset mechanism • shutter (not mechanical) • emergency switch • location of controls • warning labels • compliance label • power meter (not DIOMED 15) • calibration procedure for power measurement • aiming beam
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Surgical Diode Laser
Safety Features (continued)
The Diomed Surgical Laser is equipped with the following additional safety features: • self test • time out (automatic return to STANDBY mode) • laser condition monitoring • pulse duration monitoring • power diodes watchdog • microprocessor watchdog • main power fail protection • power supply monitor • temperature monitors
Key Switch The unit cannot be turned on without the key switch. It is recommended that the keys be assigned to one or two key holders who should make the keys available for scheduled procedures only, thus preventing unauthorized use of the system.
Remote Interlock The system is provided with a remote interlock socket, which can be connected to the door switch. This will automatically turn the system to STANDBY mode in the event of the door being opened during the procedure.
Remote Interlock Bypass If the door switch facility is not used a remote interlock bypass must be connected before the system will operate. 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. This can be supplied by DIOMED on request. These precautions will ensure that the possibility of electromagnetic emissions is minimized.
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Surgical Diode Laser
DESCRIPTION OF DIOMED SURGICAL LASER
Components
The Diomed Surgical Laser consists of three main components: 1. The main enclosure provides housing for the laser module containing all the optics, heatsink, microprocessor based control electronics and power supplies 2. The footswitch to activate the radiation when in READY mode 3. Optical fibers for delivering the radiation to tissue
Location of Controls on the Diomed Surgical Laser FIGURE 2: Front and Side Panel
Operating Mode
Menu Display Menu Select
Mode Select
Standby/Ready
Power Indicator Key Switch
Calibration Port (Not Diomed 15)
Laser Power (W) Pulse Duration (s) Pulse Interval (s)
Laser Aperture
Emergency Switch
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Surgical Diode Laser
FRONT PANEL The main operating controls, apart from the main power switch, for the Diomed Surgical Laser are located on the front panel of the main enclosure.
Mode Select
To select the operating mode. Available modes are CONTINUOUS, PULSE and REPEAT PULSE and are indicated above the mode select key.
Power Indicator
When lit the main power switch is ON and the power is being provided to the system.
Key Switch
Master control for the device. The key is removable in the OFF position and the laser is not operable when the key is removed. The key switch activates a self-test program.
Laser Power Control
To increase or decrease the output power in all operating modes: • 0.5W to 5 W in 0.5W increments • 5W to maximum W in 1W increments
Pulse Control
To increase or decrease the pulse duration in pulse and repeat pulse modes: • 0.1 second – 9.9 seconds in 0.1 second increments in pulse mode • 0.1 second – 1.0 seconds in 0.1 second increments in repeat pulse mode (Long pulses from 10 seconds to 3200 seconds are available through the Countdown Mode, for descriptions see MENU Section).
Interval Control
To increase and decrease the interval between the pulses in the repeat pulse mode: 0.1 seconds – 1.0 seconds in 0.1 second increments
Emergency Switch
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To immediately shutdown the laser in case of emergency. After emergency activation the key switch must be used to restart the system.
Surgical Diode Laser
Front Panel (continued)
STANDBY / READY Button To select STANDBY or READY mode. Radiation is possible only in the READY mode. When the READY request is made the READY light (emission indicator) flashes before the system enters READY mode. By pressing the button a second time the system will return to STANDBY mode. If the footswitch is pressed when READY request is made or during the flashing of the READY light, the message 'Footswitch Held Down' is displayed and the footswitch should be released before the operation can continue. The message will disappear when the footswitch is released.
Menu Select To enable selection of Menu commands. To move between commands use the up (S) and down (T) keys.
Menu Display This displays all menu options and information.
SIDE PANEL
Calibration Port For use in the calibration of non-contact optical fibers (Not included on the Diomed 15 model).
Laser Aperture For the connection of optical fibers via an SMA905 connector. Use only Diomed approved or Diomed labeled optical fibers. Damage caused by use of unapproved fibers will invalidate the warranty.
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Surgical Diode Laser
REAR PANEL The following components are located on the rear panel of the unit. Figure 3 shows the location of these components.
Main Power Switch
To activate the main electrical power to the system. The main power switch is located adjacent to the main power supply inlet on the rear panel.
Main Power Inlet Socket
To connect an IEC power cord.
Potential Equalization Point
To connect potential equalization line.
Voltage Selector
Voltage selector for different power voltages.
Fuses
115V Operation: 2 x T10A H250V (Diomed 60) 2 x T4A H250V (Diomed 30, 15)
Footswitch Socket
To connect the footswitch cable connector.
Remote Interlock Socket
To connect the interlock cable connector. Otherwise fit the supplied blanking connector.
Serial port
RS-232 serial interface to connect a computer to the unit.
Serial Port
Remote Interlock Socket
Footswitch Socket
FIGURE 3: Rear Panel
Voltage Selector and Fuses Potential Equalisation Point
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Main Power Supply Inlet
Main Power Switch