Operator Manual
79 Pages
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Selecta II
TM
Frequency-doubled, Q-switched Nd:YAG (532 nm) Ophthalmic Laser Operator Manual
This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Lumenis, Inc. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes translation into another language. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Lumenis and the Lumenis logo are registered trademarks of Lumenis, Inc. Coherent and the Coherent logo are registered trademarks of Coherent, Inc. Kodak is a registered trademark of Eastman Kodak Company. Puritan is a registered trademark of Hardwood Products Company LP. Selecta II is a trademark of Lumenis, Inc. Zap-It is a registered trademark of Kentek Corporation.
Manufactured by:
1870 S Milestone Dr Salt Lake City, UT 84104 USA Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 63303 Dreieich, Germany +49.6103.8335.0 © Lumenis, Inc. Published in USA 0637-121-01 Revision K Lumenis ECO: 0004417 Effective Date: 29 September 2015
Contents
Contents Operation
Overview... 1 Introduction... 3 Selecta II Components... 4 Laser module... 5 Remote control... 5 Laser console... 5 Footswitch... 5 Main power cable... 5 Door interlock plug... 5 Laserized mirror... 6
Connection Diagram... 7 Connection Instructions... 8 Inspect the Selecta II components... 8 Attach the laser module to your slit lamp... 8 Connect the laser module power cable to the laser console... 10 Secure the laser module cable... 11 Connect the remote control... 12 Connect the footswitch... 13 Connect the interlock plug... 14 Plug in the main power cable... 15
Laser Basics... 16 Turning on the laser... 16 Turning off the laser... 17 Emergency off... 17
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Contents
Disconnecting the laser... 18 Moving the laser... 18 System beeps... 18
General Remote Control Functions... 19 Selection buttons, icons, and displays... 19 Laser emission... 20 Standby/Ready... 21 Aiming beam... 22
Remote Control Treatment Settings... 23 Energy... 23 Total energy and pulse count displays... 24
Slit Lamp Setup... 25 Laser Setup on the Slit Lamp... 26 Preoperative Instructions... 28 Intraoperative Instructions... 29 Postoperative Instructions... 30
Maintenance
Overview... 31 Troubleshooting Guide... 33 User Maintenance... 37 Annual laser maintenance... 37 Laser repair... 37 Inspect the Selecta II components... 37 Clean the laser module... 37 Clean the external surfaces of the laser console... 38 Water utilities... 38
External Door Interlock Pin Assignments... 39 Voltage Selection... 40 Changing the Fuses... 42 Energy Calibration... 44 Disclaimer warning... 44 Calibration setup... 45 Calibration instructions... 46
Specifications... 47 Warranty Information... 49 Decontamination of Returned Equipment... 49
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Contents
Safety and Regulatory
Overview... 51 Introduction... 53 Laser Safety Eyewear... 54 Additional Ocular Protection... 57 Additional Safety Considerations... 58 Electrical hazards... 58 Fire hazard... 58 Protecting nontarget tissues... 58
Regulatory Compliance... 59 Key lock switch... 59 Emergency off pushbutton... 59 Laser emission indicator... 59 Remote interlock... 59 Manual reset... 60 Protective housing... 60 Safety interlocks... 60 Location of controls... 60 Eye filter... 60 Safety shutter... 61 Electronic fault detection circuitry... 61
Location of Regulatory and Other System Labels... 62
Professional Use Instructions
Overview... 67 Description of System... 69 Clinical Procedure and Parameters... 69 Selecta II Mechanism of Action... 70 Indications for Use... 70 Contraindications for Use... 70 Complications and Adverse Events... 70 Precautions... 71 Decontamination Certificate... 73
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1
Operation
Overview •
Selecta II Components 4
•
Connection Diagram 7
•
Connection Instructions 8
•
Laser Basics 16
•
Remote Control Functions 19
•
Remote Control Treatment Settings 23
•
Slit Lamp Setup 25
•
Laser Setup on the Slit Lamp 26
•
Operation Instructions 28
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Introduction 3
Introduction The Lumenis Selecta II laser introduces a new approach to ophthalmic laser surgery for the treatment of patients with open-angle glaucoma. Using an innovative short-pulse technology, the Selecta II delivers the necessary wavelength and energy to perform laser trabeculoplasty. The complete Selecta II system comprises a laser delivery module that mounts to your existing slit lamp, a convenient remote control, and a laser console containing the power supply. Lumenis lasers and delivery systems are precision medical instruments. They have undergone extensive testing and with proper handling are useful and reliable clinical instruments. If you have questions regarding your laser or delivery system, contact your local Lumenis representative. WARNING - Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.
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4 Operation
Selecta II Components The Selecta II laser system comprises a laser module, a remote control, a laser console, a footswitch, and all of the electrical and fiber optic cables necessary for proper connection. Other components necessary for operation, such as an interlock plug and laserized mirror, are also included.
Remote control Laser module
Footswitch
Main power cable
Laser console
Interlock plug
Selecta II components
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Laserized mirror
Selecta II Components 5
Laser module The laser module attaches to a standard diagnostic slit lamp, enabling the laser module to be used as a therapeutic laser device. It houses the treatment and aiming beams, laser source, and associated optics.
Remote control The remote control is the control panel for the Selecta II laser. The remote control allows you to select treatment settings, such as energy and aiming beam intensity.
Laser console The laser console houses the main power key switch, emergency off button, control electronics, and power supply. The laser console is the central unit to which all of the other laser components attach.
Footswitch The footswitch activates the laser treatment beam.
Main power cable The main power cable connects the laser to the main power source.
Door interlock plug The door interlock is a safety feature that disables the laser if someone opens the treatment room door or removes the interlock plug while the laser is in ready mode.
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6 Operation
Laserized mirror The Lumenis laserized mirror replaces your standard slit lamp illumination mirror. The laserized mirror has a black, non-reflective coating that eliminates distracting reflections from the backside of the laser delivery mirror. It is three millimeters shorter than a standard illumination mirror, allowing room for eye safety filters, which prevent laser light from reflecting back through the microscope into the surgeon’s eyes.
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Connection Diagram 7
Connection Diagram
Interlock
fl Footswitch Remote
fl
Laser module
fl
Unused, capped port
Main power To electrical outlet Laser console (back panel)
Selecta II connections
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8 Operation
Connection Instructions Inspect the Selecta II components Before connecting the Selecta II components, inspect the individual components, cables, and electrical connections for evidence of dirt, debris, or damage. Check the electrical cables to ensure that they are not frayed or split.
Attach the laser module to your slit lamp 1
Remove the slit lamp applanation tonometer, if it is not already removed.
2
Rotate the slit projector to the left of the eyepieces (as viewed from the physician’s side).
3
Remove the slit lamp illumination mirror by sliding it out of the mirror holder.
4
Insert and slide the Lumenis laserized illumination mirror, wide-end first, into the mirror holder; avoid touching the surface of the mirror.
Insert the Lumenis laserized mirror into the mirror holder
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Connection Instructions 9
5
Position the laser module so that the eye safety filter is parallel to the slit lamp magnification optics housing, as shown.
6
Carefully lower the laser module onto the tonometer support post and anchor pin. The laser module is properly mounted when the tonometer support post and anchor pin on the slit lamp connect firmly into the corresponding receptacles on the laser module, as shown.
Tonometer support post and anchor pin 8 6 4
03
Position and mount the laser module onto the slit lamp tonometer support post
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10 Operation
Connect the laser module power cable to the laser console Plug the laser module power cable into the laser console, as shown.
Laser module
Laser console (back panel)
Connect the laser module power cable to the laser console
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Connection Instructions 11
Secure the laser module cable Secure the laser module power cable to the slit lamp headrest using the Velcro® straps.
Velcro strap
Velcro strap
Secure the laser module cable to the slit lamp headrest
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12 Operation
Connect the remote control Plug the remote control cable into the remote control receptacle. Fingertighten the screws to secure.
Remote
Laser console (back panel)
Connect the remote control
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Connection Instructions 13
Connect the footswitch Plug the footswitch cable into the footswitch receptacle. If the footswitch is not properly connected when the laser is turned on, F52 displays on the remote control display and the laser cannot be placed in ready mode.
Footswitch
Laser console (back panel)
Connect the footswitch
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14 Operation
Connect the interlock plug Regardless of whether a door interlock is used, the interlock plug must be inserted into the interlock receptacle to operate the laser. If a door interlock will be used with the laser, plug the interlock plug and its associated door interlock cable into the interlock receptacle. When a door interlock is used, the laser can only be placed in ready mode when the interlocked door is closed. If the interlocked door is subsequently opened, or the plug is removed, the laser is disabled and F3 illuminates on the remote control display.
Interlock
Laser console (back panel)
Connect the interlock plug
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Connection Instructions 15
Plug in the main power cable 1
Ensure that the laser key switch is turned off.
2
Insert the main power plug into the main power receptacle, as shown.
3
Plug the other end into an electrical outlet.
To electrical outlet
Laser console (back panel)
Plug in the main power cable
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16 Operation
Laser Basics Turning on the laser Insert the key into the key switch, turn to the II (start) position, and release. Upon release, the key automatically springs back to the I (on) position.
Key switch
A system self-test and warm-up begins. During self-test and warm-up, the top remote control display illuminates a countdown. When the countdown finishes, the laser emission indicator illuminates, the system beeps, and the aiming beam appears. The standby icon on the remote control illuminates, and the laser is in standby mode. The laser defaults to the settings last used.
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