LUMENIS SELECTA - Page 8

LUMENIS SELECTA

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Selecta

PBL200051, Rev J

8  Safety and Regulatory

Table of Contents

Default Chapter3
- Table of Contents3
Safety and7
Introduction9
Laser Safety Eyewear10
Additional Ocular Protection13
Additional Safety Considerations14
- Electrical Hazards14
- Fire Hazard14
- Protecting Nontarget Tissues14
Regulatory Compliance15
- Key Lock Switch15
- Emergency off Pushbutton15
- Laser Emission Indicator15
- External Door Interlock15
- Manual Reset15
- Protective Housing16
- Safety Interlocks16
- Location of Controls16
- Eye Filter16
- Safety Shutter16
- Electronic Fault Detection Circuitry16
Location of Regulatory and Other System Labels17
Operation25
Introduction27
Selecta System Components29
- Laser Module30
- Remote Control30
- Slit Lamp Table and Console30
- Footswitch and Joystick Pushbutton30
- Main Power Cable30
- External Door Interlock Plug30
Connection Instructions31
- Inspect the Selecta Components31
- Connect the Remote Control31
- Connect the Footswitch (Optional)33
- Connect the External Door Interlock Plug35
- Plug in the Main Power Cable36
- Installing Optional Accessories37
- Attaching the Laserlink S Delivery Device40
System Basics42
- Main System Controls42
- Turning on the System44
- Turning off the System44
- Standby, Ready, and Laser Emission Mode45
- Emergency off46
- System Beeps47
- Disconnecting the System47
- Moving the System47
Slit Lamp Basics48
- Slit Lamp Positioning and Joystick Control48
- Slit Lamp Controls48
- Slit Lamp Controls50
- Laser Controls on the Slit Lamp51
Laser Basics52
- Remote Control52
- Photodisruptor Mode-Remote Control Screen52
- SLT Mode-Remote Control Screen53
- PC (External Photocoagulator) Mode-Remote Control Screen54
- Options Screen Mode-Remote Control Screen55
- Standby, Ready, and Laser Emission Mode56
- Laser Mode58
- Aiming Beam59
Remote Control System Options60
- Select the Options Screen60
- Language61
- LCD Screen Brightness62
- Laser Activation Mode-Joystick or Footswitch63
- Volume64
Remote Control Treatment Settings65
- Energy-Photodisruptor and SLT Mode65
- Total Energy and Pulse Count Displays-Photodisruptor and SLT Mode66
- Burst Mode-Photodisruptor Laser Mode67
Preoperative Setup of the Slit Lamp and Laser68
- Focusing the Slit Lamp68
- Verify that the Slit Spot Is Centered69
- Verify the Laser Aiming Beam Accuracy-YAG70
- Verify the Laser Aiming Beam Accuracy-SLT71
Operation Instructions73
- Preoperative Instructions73
- Intraoperative Instructions73
- Postoperative Instructions74
Troubleshooting Guide77
- Electrical Power Source77
- System Console Electrical77
- Delivery System Connection77
- External Door Interlock77
User Maintenance82
- Annual Laser Maintenance82
- Laser Repair82
- Inspecting the Laser System Components82
- Cleaning the Slit Lamp and Laser Module Optics82
- Cleaning the External Surfaces of the Laser Console and Slit Lamp83
- Cleaning and Disinfecting Areas of Patient Contact83
- Clean the Gonioscopy Contact Lens84
- Disinfect the Gonioscopy Contact Lens84
- Sterilize the Gonioscopy Contact Lens84
- Water Utilities84
External Door Interlock Pin Assignments85
Changing the Fuses86
- Changing the Slit Lamp Illumination Bulb88
Energy Calibration90
- Disclaimer Warning90
Electromagnetic Compatibility91
Specifications92
- Electrical Requirements93
- Physical Characteristics93
Warranty Information95
Decontamination of Returned Equipment95
98  Professional Use Instructions98
General Intended Use100
SLT Clinical Procedure and Parameters102
- Selective Laser Trabeculoplasty (SLT)-532Nm Nd:yag102
- SLT Mechanism of Action102
- SLT Contraindications for Use103
- SLT Complications and Adverse Events103
- SLT Precautions103
Photodisruptor Clinical Procedure and Parameters104
- Photodisruption-1064 Nm Nd:yag104
- General Description of Treatments104
- Tissue Effects104
Posterior Capsulotomy-1064 Nm Nd:yag105
- Contraindications105
- Warnings105
- Precautions109
- Energy Use109
- Patient Considerations110
- Adverse Effects110
Iridotomy-1064 Nm Nd:yag111
- Contraindications111
- Warnings111
- Poor Candidates for Nd:yag Laser Iridotomy112
- Intraocular Pressure Rise112
- Damage to the Lens112
- Inadvertent Patient Movement113
- Bleeding113
- Corneal Damage114
- Retinal Damage114
- Closure of the Iridotomy with Time114
- Failure to Control Glaucoma114
- Patients at Special Risk114
- Precautions115
EMC Guidance and Manufacturer's Declarations119
Appendix 1123
Decontamination Certificate123

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