Operator Manual
124 Pages
Preview
Page 1
3
Contents Safety and Regulatory
Introduction...9 Laser Safety Eyewear... 10 Additional Ocular Protection...13 Additional Safety Considerations... 14 Electrical hazards... 14 Fire hazard... 14 Protecting nontarget tissues... 14
Regulatory Compliance... 15 Key lock switch... 15 Emergency off pushbutton... 15 Laser emission indicator... 15 External door interlock... 15 Manual reset... 15 Protective housing... 16 Safety interlocks... 16 Location of controls... 16 Eye filter... 16 Safety shutter... 16 Electronic fault detection circuitry... 16
Location of Regulatory and Other System Labels... 17
Operation
Introduction... 27 Selecta System Components... 29 Laser module... 30 Remote control... 30 Slit lamp table and console... 30 Footswitch and joystick pushbutton... 30
Selecta PBL200051, Rev G
4 Contents
Main power cable... 30 External door interlock plug... 30
Connection Instructions... 31 Inspect the Selecta components... 31 Connect the remote control... 31 Connect the footswitch (optional)... 33 Connect the external door interlock plug... 35 Plug in the main power cable... 36 Installing optional accessories... 37 Attaching the LaserLink S delivery device... 40
System Basics... 42 Main system controls... 42 Turning on the system... 44 Turning off the system... 44 Standby, Ready, and Laser Emission mode... 45 Emergency off... 46 System beeps... 47 Disconnecting the system... 47 Moving the system... 47
Slit Lamp Basics... 48 Slit lamp positioning and joystick control... 48 Slit lamp controls... 48 Slit lamp controls... 50 Laser controls on the slit lamp... 51
Laser Basics... 52 Remote Control... 52 Photodisruptor Mode-remote control screen... 52 SLT Mode-remote control screen... 53 PC (external photocoagulator) Mode-remote control screen... 54 Options Screen Mode-remote control screen... 55 Standby, Ready, and Laser Emission mode... 56 Laser mode... 58 Aiming beam... 59
Remote Control System Options... 60 Select the options screen... 60 Language... 61 LCD screen brightness... 62 Laser activation mode-Joystick or Footswitch... 63 Volume... 64
Remote Control Treatment Settings... 65 Energy-photodisruptor and SLT mode... 65 Total energy and pulse count displays-Photodisruptor and SLT mode... 66 Burst mode-Photodisruptor laser mode... 67
Preoperative Setup of the Slit Lamp and Laser... 68 Focusing the Slit Lamp... 68 Verify that the slit spot is centered... 69 Selecta PBL200051, Rev G
Contents 5
Verify the laser aiming beam accuracy-YAG... 70 Verify the laser aiming beam accuracy-SLT... 71
Operation Instructions... 73 Preoperative Instructions... 73 Intraoperative Instructions... 73 Postoperative Instructions... 74
Maintenance
Troubleshooting Guide... 77 Electrical power source... 77 System console electrical... 77 Delivery system connection... 77 External door interlock... 77
User Maintenance... 82 Annual laser maintenance... 82 Laser repair... 82 Inspecting the laser system components... 82 Cleaning the slit lamp and laser module optics... 82 Cleaning the external surfaces of the laser console and slit lamp... 83 Cleaning and disinfecting areas of patient contact... 83 Clean the gonioscopy contact lens... 84 Disinfect the gonioscopy contact lens... 84 Sterilize the gonioscopy contact lens... 84 Water utilities... 84
External Door Interlock Pin Assignments... 85 Changing the Fuses... 86 Changing the Slit Lamp Illumination Bulb... 88
Energy Calibration... 90 Disclaimer warning... 90
Electromagnetic Compatibility... 91 Specifications... 92 Warranty Information... 95 Decontamination of Returned Equipment... 95
Professional Use Instructions
General Intended Use... 100 SLT Clinical Procedure and Parameters... 102 Selective Laser Trabeculoplasty (SLT)-532nm Nd:YAG... 102 SLT Mechanism of Action... 102 SLT Contraindications for Use... 103 SLT Complications and Adverse Events... 103 SLT Precautions... 103
Photodisruptor Clinical Procedure and Parameters... 104 Photodisruption-1064 nm Nd:YAG... 104 General description of treatments... 104 Tissue effects... 104
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6 Contents
Posterior Capsulotomy-1064 nm Nd:YAG... 105 Contraindications... 105 Warnings... 105 Precautions... 109 Energy use... 109 Patient focus... 110 Adverse effects... 110
Iridotomy-1064 nm Nd:YAG... 111 Contraindications... 111 Warnings... 111 Poor candidates for Nd:YAG laser iridotomy... 112 Intraocular pressure rise... 112 Damage to the lens... 112 Inadvertent patient movement... 113 Bleeding... 113 Corneal damage... 114 Retinal damage... 114 Closure of the iridotomy with time... 114 Failure to control glaucoma... 114 Patients at special risk... 114 Precautions... 115
Appendix 1
Selecta PBL200051, Rev G
EMC Guidance and Manufacturer’s Declarations... 119 Decontamination Certificate... 123
7
Safety and Regulatory
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8 Safety and Regulatory
Selecta PBL200051, Rev G
Introduction 9
Introduction The Selecta ophthalmic laser systems are classified as Class IIIb lasers by the Center for Devices and Radiological Health of the Food and Drug Administration and as Class 3b by the International Standard IEC 60825. Users must take precautions to prevent exposure of laser energy to the eyes and skin from either direct or diffusely reflected laser beams, except as a therapeutic application. Additional precautions must be taken to prevent fire, electrical injury, and explosion. Lumenis does not make recommendations regarding the practice of medicine. Laser treatment parameters are provided as a guide. Individual treatment should be based on clinical training, clinical observation of laser-tissue interaction, and appropriate clinical endpoints. See the American National Standard (ANSI) publications Z136.3-2005, ANSI Z136.1-2000, and EN 207 for recommendations on the safe use of lasers in health care facilities. This package conforms to the conditions and limitations specified in US federal regulations, title 49 CFR 173.426 for radioactive material, excepted packagearticles manufactured from natural thorium, UN 2910.
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10 Safety and Regulatory
Laser Safety Eyewear Laser safety eyewear is routinely required with most lasers. When using the laser system, the Laser Safety Officer should determine the need for safety eyewear based on the Maximum Permissible Exposure (MPE), Nominal Hazard Zone (NHZ), the Nominal Ocular Hazard Distance (NOHD), and the optical density (OD) for each of the available laser emissions and the configuration of the treatment room (usually within the controlled area). For additional information, refer to ANSI Z136.1-2000, ANSI Z136.3-2005, or International Standard IEC 60825-1: 2001. The following formula was used to calculate the worst case NOHD for Lumenis Selecta lasers and compatible delivery systems:
NOHD = Z +
1 θ
4 π
Φ Pf - a2 MPE
where, Z
= the distance of the beam waist from the laser system;
a
= the beam waist diameter (1/e2 of axial irradiance for gaussian beam);
θ
= minimum full angle beam divergence (1/e2 of axial irradiance for gaussian beam);
e
≈ 2.7182818285, the base of natural logarithms;
Φ
= maximum energy of one laser pulse or maximum CW laser power;
Pf
= the profile correction factor (1 for uniform profile or 2 for gaussian irradiance profile);
MPE
= Maximum Permissible Exposure, in energy density units (energy per unit area),þor power density units (power per unit area);
NOHD = the Nominal Ocular Hazard Distance (measured from laser aperture); = the distance required to reduce the energy density or power density to the MPE.
Selecta PBL200051, Rev G
Laser Safety Eyewear 11
Z
1 θ
NOHD = Z +
Laser system
4 Φ Pf - a2 π MPE
a
φ
Using this approach we derive the following values: Laser System
θ
Φ
MPE
Pf
a
Z
Selecta Duet 1064 nm laser
0.262
0.03 J
1.67 (10-6) J/cm2
2
0.0007 cm
9.3 cm
Selecta Duet 532 nm laser
0.016
0.002 J
0.50 (10-6) J/cm2
2
0.004 cm
9.3 cm
which results in a worst case NOHD of : Laser System
NOHD
Selecta Duet 1064 nm laser
8.4 meters
Selecta Duet 532 nm laser
63.0 meters
All personnel who are within the NOHD are considered to be within the controlled area and shall wear eye protection with a minimum optical density (OD) of: Laser System
OD
Selecta (all models)
5.0
Laser safety eyewear must also be resistant to physical damage or photobleaching resulting from laser exposure as per ANSI Z136.1-2000,
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12 Safety and Regulatory
section 4.6.2 and Appendix C. For users who must comply with EN 207, the safety eyewear must have a protection class of L5. In addition to providing the required laser safety eyewear, take the following steps to secure the treatment room, or the controlled area:
1 To alert personnel before they enter the controlled area, place a warning sign on the outside of the treatment room door when the laser is in use.
2 Close the treatment room door during operation of the laser. 3 External door interlocks that automatically disable the laser when the treatment room door is opened may be installed. A blocking barrier, screen, or curtain capable of blocking or filtering the laser beam could be placed to create a controlled area inside a large treatment room. The barrier should be made of material that can withstand the power of the treatment beam for the maximum exposure time, relative to the configuration of the controlled area and the treatment parameters for the specific medical application.
Selecta PBL200051, Rev G
Additional Ocular Protection 13
Additional Ocular Protection WARNING - Always verify that the delivery device is properly connected to the laser. An improper connection may result in an inadvertent secondary laser beam. Severe eye or tissue damage could occur. WARNING - Never substitute prescription eyewear for the appropriate laser safety eyewear, as severe eye damage could occur. Prescription eyewear can concentrate the laser light to the eye and/or can be shattered by a high power density beam, possibly causing severe eye damage. WARNING - Severe and irreversible eye damage and scarring may occur from direct or indirect exposure to the treatment beam. The predominant ocular structures at risk are dependent on the laser wavelength in use. In general, visible and near-infrared wavelengths are most damaging to the retina, while ultraviolet or infrared wavelengths are most damaging to the cornea and sclera. Severity of injury depends on how concentrated or diffused the treatment beam is and the length of exposure. A thorough understanding of the specific ocular risks and safety precautions for each laser wavelength is necessary to ensure the safety of the patient and operating personnel. WARNING - Never look directly into any optical lens, except for therapeutic purposes, nor any optical fiber, probe, or laser system aperture while the laser is energized. Severe eye damage could occur. Turn off the laser before inspecting any delivery system or laser components.
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14 Safety and Regulatory
Additional Safety Considerations Electrical hazards WARNING - Never remove the laser protective covers. Removing the covers will expose the user to high voltage components, the laser resonator, and possible laser radiation. Only Lumenis-certified service technicians shall work inside the laser console. WARNING - The area around the laser and footswitch should be kept dry. Do not operate the laser if any of the cords are faulty or frayed. The laser should undergo routine inspection and maintenance per Lumenis manufacturer’s recommendations and institutional standards.
Fire hazard WARNING - Do not use this device in the presence of flammables or explosives, such as volatile anesthetics, alcohol, certain surgical preparation solutions, and similar substances. An explosion and/or fire could occur.
Protecting nontarget tissues WARNING - Except during actual treatment, the system must always be in the standby mode. Maintaining the system in the standby mode prevents accidental laser exposure if the footswitch or joystick laser activation pushbutton is inadvertently depressed. WARNING - Never place hands or other objects in the path of the laser beam. Severe burns could occur. WARNING - Only the person directing the laser beam should have access to the laser footswitch or joystick pushbutton. Use caution depressing the laser footswitch when it is in proximity to footswitches for other equipment. Make sure the footswitch depressed is the correct one to avoid accidental laser exposure. WARNING - To avoid accidental exposure to laser radiation, always move the patient out of the beam path before restarting the system. WARNING - Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. CAUTION - U.S. fedederal law restricts this device to sale by or on the order of a physician. CAUTION - Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the use of these instruments.
Selecta PBL200051, Rev G
Regulatory Compliance 15
Regulatory Compliance Lumenis lasers and delivery systems comply with 21 CFR Chapter 1, Subchapter J, as administered by the Center for Devices and Radiological Health of the US Food and Drug Administration (FDA). CE-labeled devices comply with all appropriate performance standards as specified in Annex II of the Medical Device Directive MDD 93/42/EEC.
Key lock switch To prevent unauthorized use, the laser can only be turned on with the master key, the key can only be removed when the laser is turned off, and the laser only operates when the key is inserted into the keyswitch. When the keyswitch is turned to the start position, the laser power-up sequence is initiated.
Emergency off pushbutton The laser has an emergency off pushbutton which immediately turns off the laser.
Laser emission indicator Illumination of the laser emission indicator on the remote control provides a visible warning to the operator that after approximately 2 seconds laser radiation is accessible. The time delay is incorporated to allow appropriate action by the operator to avoid unintentional laser radiation exposure.
External door interlock An external door interlock receptacle and plug are provided to disable the laser if the treatment room doors are opened. Refer to the Laser Safety Eyewear section of this manual for additional information.
Manual reset If laser emission is externally interrupted during treatment by remote interlock activation, the laser will automatically go into standby and the safety shutter will revert to a closed position. To resume treatment, manually reset the laser by placing the laser in ready mode. If laser emission is interrupted during treatment by main electrical power loss, the laser system will automatically turn off. To resume treatment after an electrical power loss, the system must be manually restarted by rotating the keyswitch to the start position.The laser will automatically go into standby when electrical power is resumed. To resume treatment, manually reset the laser by placing the laser in ready mode.
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16 Safety and Regulatory
Protective housing The laser has a protective housing that prevents unintended human access to laser radiation above Class I limits. The housing must only be opened by a Lumenis-certified technician.
Safety interlocks The protective housing is not designed to be removed by the user during operation or maintenance. Therefore, the laser does not have, and is not required to have, any safety interlocks within the meaning of US FDA 21 CFR, Section 1040 or International Standard IEC 60825-1. However, the protective housing cannot be easily opened without special tools.
Location of controls Operation and adjustment controls are located so that the user need not be exposed to laser radiation during laser operation or adjustment.
Eye filter The slit lamp has specially designed eye filters which guard the operator from exposure to laser radiation. The protective filter ensures that all laser radiation returned to the operator's eyes is below the Class I limit.
Safety shutter The laser includes an electronic safety shutter that prevents unintentional laser emission. The safety shutter opens only when the user places the system in ready mode and depresses the footswitch or joystick laser activation pushbutton. The safety shutter remains closed when the system is turned off, during self-test at system turn on, when the system is placed in standby mode, or when the safety monitor detects a fault.
Electronic fault detection circuitry If the electronic system detects a fault condition, laser exposure cannot occur. The high voltage power supply is turned off, the high voltage capacitor is discharged, the safety shutter is closed, and the footswitch and joystick laser activation pushbutton is disabled. Some fault conditions may be cleared by the operator. Refer to the Troubleshooting Guide in this manual for additional information.
Selecta PBL200051, Rev G
Location of Regulatory and Other System Labels 17
Location of Regulatory and Other System Labels As required by national and international regulatory agencies, appropriate warning labels have been mounted in specified locations. µm
Posterior Offset Posterior YAG offset
Electrical hazard (outside housing)
mJ
Energy
Laser energy
LB-1028640 REV A
Non-interlock housing danger (outside housing)
532 nm / 1064 nm OD = 5+ Laser eye safety filter
LASER APERTURE
Laser aperture
12 V / 30 W LB-005813 REV C
Joystick laser activation
Slit lamp illumination intensity
Illumination bulb specification
Laser aiming beam intensity
Location of regulatory compliance labels
Selecta PBL200051, Rev G
18 Safety and Regulatory
Slit lamp slit width selector wheel
Slit lamp illumination aperture selector wheel
duet
Slit lamp color filter selector wheel
Location of regulatory compliance labels-Illumination Tower
Selecta PBL200051, Rev G
Location of Regulatory and Other System Labels 19
Table up-down control
Emergency stop
Remote receptacle and external door interlock receptacle
3959 West 1820 South Salt Lake City, UT 84104 U.S.A. Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich, Germany +49.6103.8335.0
VISIBLE AND INVISIBLE LASER RADIATION AVOID EXPOSURE TO BEAM CLASS 3B LASER PRODUCT
MADE IN U.S.A. U.S. AND INTERNATIONAL PATENTS PENDING
CLASS 3B LASER PRODUCT per IEC 60825-1/2001 CLASS IIIb LASER PRODUCT per 21 CFR 1040
Danger Label
0044
C orth
heinla
100-240 V~
.
T
VR
nd
U
of N
IEC 60601-1 IEC 60601-1-4 IEC 60601-2-22 IEC 60825-1
Diode Laser: 635 nm, <1 mW Max, CW
AP G
!
In c
THIS PRODUCT COMPLIES WITH 21 CFR, CHAPTER I, SUBCHAPTER J
VISIBLE LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT
, America
US
50/60 Hz 3.15A
LB-006277, REV C
LB-005812 REV C
Footswitch receptacle
100-240 V~
T-3.15A 250V
Electrical specification, fuse rating, and mains receptacle
Location of regulatory compliance labels-Wheelchair-accessible table
Selecta PBL200051, Rev G
LB-006280 Rev C
Nd:YAG: 532 nm, 2 mJ Max / 3 ns pulse Nd:YAG: 1064 nm, 10 mJ Max / 3 ns pulse
CAUTION: U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON ORDER OF A PHYSICIAN
20 Safety and Regulatory
Table up-down control
Emergency stop
3959 West 1820 South Salt Lake City, UT 84104 U.S.A. Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich, Germany +49.6103.8335.0
Remote receptacle and external door interlock receptacle
CAUTION: U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON ORDER OF A PHYSICIAN
VISIBLE LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT
0044
of N
C orth
Danger Label
.
T
nd
U
Diode Laser: 635 nm, <1 mW Max, CW
CLASS 3B LASER PRODUCT per IEC 60825-1/2001 CLASS IIIb LASER PRODUCT per 21 CFR 1040
heinla VR
, America
US
LB-006277, REV C
100-240 V~ 50/60 Hz 3.15A LB-005812 REV C
Footswitch receptacle
100-240 V~
T-3.15A 250V
Electrical specification, fuse rating, and mains receptacle
Location of regulatory compliance labels-small office table Selecta PBL200051, Rev G
LB-006280 Rev C
MADE IN U.S.A. U.S. AND INTERNATIONAL PATENTS PENDING
IEC 60601-1 IEC 60601-1-4 IEC 60601-2-22 IEC 60825-1
Nd:YAG: 532 nm, 2 mJ Max / 3 ns pulse Nd:YAG: 1064 nm, 10 mJ Max / 3 ns pulse
AP G
!
In c
THIS PRODUCT COMPLIES WITH 21 CFR, CHAPTER I, SUBCHAPTER J
VISIBLE AND INVISIBLE LASER RADIATION AVOID EXPOSURE TO BEAM CLASS 3B LASER PRODUCT
Location of Regulatory and Other System Labels 21
P/N SN
3959 West 1820 South Salt Lake City, UT 84104 U.S.A.
0044
LUMENIS (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich, Germany +49.6103.8335.0
(for products shipped under the Medical Device Directive)
Lumenis contact information
CE mark
Model name, serial number, and manufacturing date
VISIBLE AND INVISIBLE LASER RADIATION AVOID EXPOSURE TO BEAM CLASS 3B LASER PRODUCT VISIBLE LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT Diode Laser: 635 nm, <1 mW Max, CW CLASS 3B LASER PRODUCT per IEC 60825-1/2001 CLASS IIIb LASER PRODUCT per 21 CFR 1040
LB-006280 Rev C
Nd:YAG: 532 nm, 2 mJ Max / 3 ns pulse Nd:YAG: 1064 nm, 10 mJ Max / 3 ns pulse
Danger label
heinla
. In c
T
VR
nd
U
of N
IEC 60601-1 IEC 60601-1-4 IEC 60601-2-22 IEC 60825-1
C orth a, Americ
US
TUV labels
MADE IN U.S.A. U.S. AND INTERNATIONAL PATENTS PENDING
100-240 V~ 50/60 Hz 3.15A
Electrical specification THIS PRODUCT COMPLIES WITH 21 CFR, CHAPTER I, SUBCHAPTER J
CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON ORDER OF A PHYSICIAN
(for FDA-compliant systems)
Patents pending
DHHS certification
FDA sales restriction
Regulatory compliance labels
Selecta PBL200051, Rev G
22 Safety and Regulatory
STOP
Emergency Stop
External door interlock receptacle
Remote receptacle
Type B electric shock protection
Mains receptacle
Footswitch receptacle
! LASER APERTURE
(Read and comprehend the operator manual before use.)
Laser aperture
Attention, read manual
Electrical hazard (outside housing)
532 nm / 1064 nm OD = 5+
100-240V~
(Replace fuse as marked.)
(The eye safety filter ensures that all laser radiation returned to the operator's eyes is below the Class I limit. The eye safety filter ID label identifies the specific laser wavelength or laser model for which the filter provides ocular protection to the operator.)
Fuse rating
Fixed eye safety filter ID
T-3.15A 250V
LB-1028640 REV A
(Danger.Visible and invisible laser light when open. Avoid eye or skin exposure to direct or scattered radiation.)
Non-Interlock housing danger (outside housing)
55ºC (131ºF) -10ºC (14ºF)
AP G
(Danger. Possible explosion hazard if used in the presence of flammable anesthetics, oxygen, or nitrous oxide.)
Flammable anesthetics and gases warning
TEMPERATURE
HUMIDITY
-10ºC – 55ºC 14ºF – 131ºF
90% @ +55ºC NON-CONDENSING
Nonoperating environmental specifications (on shipping box)
Regulatory compliance labels
Selecta PBL200051, Rev G