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Iridex IRIS Medical OcuLight SL User Manual

Iridex IRIS Medical OcuLight SL
43 pages
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IRIS Medical
®
OcuLight
®
SL/SLx
Operator Manual
PN 13099D-EN

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Iridex IRIS Medical OcuLight SL Specifications

General IconGeneral
BrandIridex
ModelIRIS Medical OcuLight SL
CategoryMedical Equipment
LanguageEnglish

Summary

About IRIDEX

Overview of IRIDEX Corporation

Provides a general overview of IRIDEX Corporation, its business, and its laser systems for ophthalmic use.

Contact Information

Lists contact details for IRIDEX, including phone numbers, email, mailing address, and authorized European representative.

About the OcuLight SL and SLx

Introduction to SL/SLx Systems

Introduces the IRIS Medical OcuLight SL and SLx laser systems, highlighting their portability and advanced diode laser technology.

Potential Adverse Effects and Cautions

Warns about potential adverse effects from improper use and provides cautions regarding device sale and laser radiation exposure.

Indications for Use

Lists the medical applications for which the SL/SLx is indicated, including various types of laser treatments for eye conditions.

Components of the SL/SLx System

Packing List and Component Check

Details the standard components included in a shipment of the SL/SLx laser system and advises on checking for damage.

Component Descriptions

Console and Operator Manual

Describes the console as the central unit and the operator manual's purpose for instructions.

Footswitch, Power Cord, and Key

Explains the function of the footswitch, AC power cord, and the key for system operation and security.

Spare Fuses

Mentions that spare AC line fuses are provided to protect the SL/SLx from over-current conditions.

Positioning and Environment for SL/SLx

Temperature, Humidity, and Electrical Requirements

Specifies operating environment conditions and electrical requirements, including grounding, for the SL/SLx.

Physical Location Considerations

Provides guidance on placing the SL/SLx on a flat surface and warns against using it near flammables or blocking electrical outlets.

Rear Panel Connections

Required Connections: Power, Footswitch, and Interlock

Outlines the necessary connections for the power cord, footswitch, and remote interlock plug for proper system operation.

Fuses

Informs about the location of two independent line fuses and when to access them for replacement.

Front Panel Controls and Connections

Control Feature Descriptions

Provides descriptions of the Laser Status Display, Treat/Standby, Mode, Key Switch, and Emergency Stop functions on the front panel.

Front Panel Control Functions

Power and Duration Controls

Explains the function of the Power Knob, Pulse Duration Knob, and Pulse Interval Knob for setting treatment parameters.

Ports and Illumination Controls

Describes the Fiber Port, LIO Connector, SmartKey, Aiming Beam Brightness, and LIO Illumination controls on the front panel.

Operating Basics

Connecting and Turning On the SL/SLx

Guides the user through connecting a delivery device and turning on the SL/SLx, including the self-test sequence.

Basic SL/SLx Operation

Turning Off and Emergency Stop

Explains how to turn off the SL/SLx, secure the key, and use the Emergency Stop button and recovery procedure.

CW-Pulse Mode Operation

CW-Pulse Overview and Settings

Introduces CW-Pulse mode and guides on setting the power level for treatment.

CW-Pulse Mode Settings

Pulse Duration and Repeat Interval Selection

Explains how to use the Duration and Repeat Interval controls to set treatment pulse parameters.

LongPulse Mode

LongPulse Overview and Entry

Explains LongPulse mode for continuous wave exposure and how to enter it by attaching a large spot delivery device.

Selecting LongPulse Parameters

Guides on selecting treatment time by adjusting the Duration control, showing duration and energy delivered.

LongPulse Mode Treatment

Initiating and Monitoring Treatment

Outlines initiating treatment, monitoring energy delivery, and resetting the counter display in LongPulse mode.

MicroPulse Mode

MicroPulse Mode Overview

Introduces MicroPulse mode for the SLx, detailing its subdivision into microsecond pulses and use with slit lamp adapters.

MicroPulse Mode Operation

Entering and Selecting Duty Factor

Explains how to enter MicroPulse mode and select preset duty factor settings using the Treat/Standby and Mode buttons.

MicroPulse Mode Customization

Custom Duty Factor and Parameter Selection

Guides on creating a custom duty factor and selecting power, pulse duration, and interval for MicroPulse treatment.

Initiating MicroPulse Treatment

Outlines the steps to initiate treatment in MicroPulse mode after setting parameters.

Customizing the SL/SLx

Adjusting Aiming Beam and LIO Illumination

Explains how to adjust the intensity of the aiming beam and the LIO illumination lamp.

Adjusting System Volume

Explains how to adjust the loudness of the audible tone emitted by the SL/SLx.

User Preferences Menu

Accessing and Configuring User Preferences

Details accessing the menu and configuring aiming laser settings, display language, and reviewing onscreen messages.

Troubleshooting Common Issues

No Display Troubleshooting

Provides troubleshooting steps for when the device display shows no output, including checking connections and fuses.

Aiming Beam Issues

Offers solutions for problems with the aiming beam, such as checking connections, controls, and the fiber optic.

Troubleshooting System Messages

Absent Beam and Onscreen Messages

Addresses troubleshooting for absent treatment beam and common onscreen messages like "Connect Footswitch".

Emergency Stop and Footswitch Problems

Covers recovery from Emergency Stop and resolving issues with a stuck footswitch.

Maintenance and Cleaning

Cleaning the Console and Footswitch

Provides instructions for cleaning the SL/SLx enclosure and the submersible footswitch, including disinfection steps.

Maintenance Procedures

Changing Fuses and Resetting Circuit Breaker

Explains how to replace AC line fuses and reset the circuit breaker for the power supply transformer.

Verifying Power Calibration

Power Calibration Procedure Overview

Explains the importance of annual power calibration verification and lists recommended power meters.

Steps for Power Calibration Verification

Details the step-by-step process for verifying the power calibration, including safety eyewear and meter positioning.

Power Calibration Verification Results

Setting Power and Recording Readings

Guides on adjusting power settings and recording meter readings to verify calibration against acceptable ranges.

Troubleshooting Calibration Deviations

Provides steps for when calibration readings fall outside acceptable levels, including contacting support.

Warranty and Service Information

Warranty, Registration, and Support

Outlines the standard factory warranty, product registration advice, and contact information for Technical Support.

Safety Information and General Measures

General Safety Practices

Addresses safe use and operation, listing protective measures like wearing safety eyewear and avoiding direct laser exposure.

Eye Safety Filters and Protection

Explains the function of eye safety filters in adapters and ophthalmoscopes to protect against backscattered laser emissions.

Laser Safety Eyewear and Hazard Distance

Eyewear Requirements and Verification

Specifies minimum O.D. for safety glasses and verifying their suitability for the SL/SLx wavelength.

Determining Safety Eyewear Need (NOHD)

Explains Nominal Ocular Hazard Distance (NOHD) and the formula to calculate it for determining safety eyewear requirements.

Laser Safety Features and NOHD

NOHD Values for Delivery Devices

Provides a table listing NOHD values for various IRIS Medical delivery devices based on MPE, aperture, and maximum power.

Key Safety Features Overview

Lists key safety features including Emergency Off, Protective Housing, and Safety Interlock at the fiber port.

Laser System Safety Mechanisms

Interlocks, Indicators, and Beam Attenuator

Describes remote interlock, key switch, audible emission indicator, and beam attenuator functions.

Viewing Optics Safety Requirements

Stresses the importance of safety filters in viewing paths of microscopes and adapters to protect the physician's eyes.

Device Labeling

Back Panel Label Information

Details the information and warnings present on the back panel label of the SL/SLx unit.

Product Identification Labels

Manufacturing, Grounding, and Footswitch Labels

Describes manufacturing, grounding, and footswitch labels, emphasizing identification and connection reliability.

Guide to Symbols

Control and Indicator Symbols Explained

Explains the meaning of various symbols used on the device for controls, indicators, and system status.

Safety and Certification Symbols Explained

Details symbols related to safety, attention, emergency stop, disposal, and certification marks like ETL and CE.

Product Specifications: Treatment and Aiming Beam

Treatment Beam Specifications

Lists specifications for the treatment beam, including wavelength, laser class, output power, duration, and repeat interval.

Aiming Beam and General System Specs

Provides specifications for the aiming beam and general system details like dimensions, mass, operating conditions, and electrical requirements.

Product Specifications and Compatibility

Onscreen Languages and Compatible Delivery Devices

Lists available onscreen languages and compatible IRIS Medical delivery devices for the SL/SLx system.

Operating Mode Compatibility Matrix

Shows a compatibility table indicating which delivery devices work with CW-Pulse, MicroPulse, and LongPulse modes.

Appendix A: Electromagnetic Emissions

Guidance on RF and Harmonic Emissions

Presents guidance and declaration on electromagnetic emissions, including RF and harmonic, for the SL/SLx.

Appendix B: Electromagnetic Immunity

Guidance on Immunity Tests

Details guidance and declaration for electromagnetic immunity, covering ESD, transients, surge, voltage dips, and magnetic fields.

Appendix C: Decontamination Certificate

Decontamination Certification Form

Provides a certificate form for users to certify proper decontamination before returning the IRIS Medical SL/SLx.

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