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Summary of Contents for Iridex LIO Plus
- Page 1 IRIDEX LIO Plus ® Operator Manual...
- Page 2 MicroPulse P3 are registered trademarks; BriteLight, CW-Pulse, DioPexy, EasyFit, EasyView, FiberCheck, G-Probe, IQ 532, IQ 577, IQ 810, LongPulse, MilliPulse, OtoProbe, PowerStep, Symphony, TruFocus, and TruView are trademarks of IRIDEX Corporation. All other trademarks are the property of their respective holders.
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Page 3: Table Of Contents
Warnings and Cautions ....................2 IRIDEX Corporation Contact Information ..............3 Operation ......................5 About the Components ....................5 Connecting the Cables to IRIDEX Lasers ..............6 Adjusting for Pupillary Distance ................6 Instructions to Treat a Patient ..................7 Troubleshooting ....................8 General Problems ......................8 Maintenance ...................... -
Page 4: Introduction
Fully enclosed optics prevent misalignment and contamination. The LIO Plus is sold to medical doctors and intended to be used by trained medical professionals. Indications for Use The LIO Plus is indicated for transpupillary retinal photocoagulation. -
Page 5: Warnings And Cautions
Severe eye or tissue damage could occur. Do not use the delivery device with any laser system other than an IRIDEX laser. Such use may void product warranties and threaten the safety of the patient, yourself, and others in the treatment room. -
Page 6: Iridex Corporation Contact Information
NOTE: This Warranty and Service statement is subject to the Disclaimer of Warranties, Limitation of Remedy, and Limitation of Liability contained in IRIDEX’s Terms and Conditions. Should you require assistance, please contact your local IRIDEX Technical Support representative or our corporate headquarters. - Page 7 88046-EN Rev A Introduction 4...
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Page 8: Operation
Operation About the Components Verify that you have received all of the components in the IRIDEX LIO Plus package, and check the ® components carefully before use to ensure that no damage occurred during transit. Along with this manual, you should have the IRIDEX LIO Plus, zero-diopter lenses, and a spare halogen bulb. -
Page 9: Connecting The Cables To Iridex Lasers
Headband height adjustment knob Color filter selector Illumination field size adjustment Connecting the Adjusting for Pupillary Cables to IRIDEX Lasers Distance OcuLight Laser Family Illumination cable Fiber-optic cable Slide to adjust IQ Laser Family Illumination cable Fiber-optic cable 88046-EN Rev A... -
Page 10: Instructions To Treat A Patient
If an examination lens was used, handle the lens according to the manufacturer’s instructions. Keep the protective cap over the fiber-optic connector when the delivery device is not in use. 7 IRIDEX LIO Plus Operator Manual 88046-EN Rev A ®... -
Page 11: Troubleshooting
• Verify that the fiber-optic connector is not damaged. • If possible, connect another IRIDEX delivery device and place the console in Treat mode. If the aiming beam is still not visible, contact your local IRIDEX Technical Support representative. No treatment beam • Verify that the remote interlock has not been activated. -
Page 12: Maintenance
Wipe the optics gently in one direction with the swab to remove all dust and debris. Repeat as needed with a fresh swab until all dust and debris have been removed from the optical surfaces. 9 IRIDEX LIO Plus Operator Manual 88046-EN Rev A ®... -
Page 13: Changing The Illumination Lamp
LIO Plus so that it points to the observer’s right. Screw on the retaining cap. Service The LIO contains no user serviceable items. LIO service must be performed by IRIDEX trained service personnel. Contact IRIDEX or your distributor for service information. 88046-EN Rev A... -
Page 14: Safety And Compliance
Distance (NOHD) for each of the delivery devices used with the laser system, as well as the configuration of the treatment room. Eyewear safety parameters are tabulated for each compatible IRIDEX laser console in the appropriate laser console operator manual. For additional information, refer to ANSI Z136.1, ANSI Z136.3, or IEC 60825-1. -
Page 15: Safety Compliance
The delivery device is also safety-interlocked at the fiber-optic port on the laser. The IRIDEX LIO Plus is classified as a Group 1 instrument according to EN ISO 15004-2:2007. This classification was determined using a 20D ophthalmoscopy lens. The IRIDEX LIO Plus is classified as a Group 1 instrument according to ANSI Z80.36-2016. -
Page 16: Labels
Labels CE Labels Laser Aperture Label LASER APERTURE OUVERTURE LASER IRIDEX Corporation (01)00813125 1212 Terra Bella Ave. 015619(11)20 Mountain View, CA 0409(21)1234 94043 USA Product Labels www.iridex.com 30903-H500 Tel: 650-940-4700 13 IRIDEX LIO Plus Operator Manual 88046-EN Rev A ®... -
Page 17: Symbols
Symbols These symbols apply to the LIO Plus. Refer to the operator manual of your IRIDEX laser console for additional symbols. Authorized Representative Caution CE Mark in the European Community Serial Number Manufacturer Part Number Waste Electrical CSA Group Mark... -
Page 18: Iridex ® Lio Plus Specifications
10° C (50° F) to 35° C (95° F) Humidity Limits 20-80% Relative Humidity, Non-condensing Storage Environment Temperature Limits: -20° C (-4° F) to 60° C (140° F) Humidity Limits 20 - 80% Relative Humidity, Non-condensing 15 IRIDEX LIO Plus Operator Manual 88046-EN Rev A ®... -
Page 19: Emc Safety Information
EMC Safety Information The laser system (console and accessories) needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section. Portable and mobile RF communications equipment can affect this system. This laser system has been tested and found to comply with the limits for medical devices in IEC 60601-1-2 according to the tables in this section. - Page 20 IEC 61000-4-8 of a typical location in a typical commercial or hospital environment. NOTE: U is the AC mains voltage prior to application of the test level. 17 IRIDEX LIO Plus Operator Manual 88046-EN Rev A ®...
- Page 21 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
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