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Related Manuals for Iridex EndoProbe Series
Summary of Contents for Iridex EndoProbe Series
- Page 1 EndoProbe Handpiece, ® OtoProbe™ Device and FlexFiber™ Device Operator Manual...
- Page 2 BriteLight, CW-Pulse, DioPexy, DualSense, EasyFit, EasyView, FiberCheck, FlexFiber, G-Probe, IQ 532, IQ 577, IQ 810, LongPulse, MicroPulse, MilliPulse, OtoProbe, PowerStep, SmartKey, Symphony, Tri-Mode, 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
Precautions ........................1 Recommended Procedure ....................1 Power and Duration ......................1 Warnings and Cautions ....................2 References ........................3 Compatible IRIDEX Lasers...................4 IRIDEX Corporation Contact Information ..............4 Operation ..................... 5 About the Components ....................5 EndoProbe Models ......................5 OtoProbe Models ......................6 FlexFiber Models ......................6 Eye Safety Filters ......................6 Connecting the Components ..................7... - Page 4 Contents 13103-EN Rev K...
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Page 5: Introduction
Introduction IRIDEX probes come with a universal SMA connector that allows them to be used with validated compatible laser systems. Indications for Use The EndoProbe Handpiece is indicated for use in performing ophthalmic laser treatments to deliver ® laser energy to the treatment area inside the eye. The EndoProbe is cleared for use for the particular indications of the compatible laser system to which it is attached. -
Page 6: Warnings And Cautions
Refer to your laser manual for specific eye safety filter information. The IRIDEX eye safety filter (ESF) is designed to be used with an IRIDEX laser. Always ensure that the ESF is properly connected to the laser during use. -
Page 7: References
Information is also provided on what to do if such a fire does occur. IRIDEX Corp. recommends the safety guidelines of American National Standards ANSI Z136.3-2007 as follows: • Care must be taken to protect endotracheal tubes from laser radiation. Ignition or perforation of endotracheal tubes by the laser beam could result in serious or fatal patient complications. -
Page 8: Compatible Iridex Lasers
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 9: Operation
Operation About the Components After unpacking the contents of your IRIDEX laser probe, ensure that you have all of the components ordered. Check the components carefully before use to ensure that no damage occurred during transit. Ensure that the appropriate eye safety filter is installed prior to using a probe. -
Page 10: Otoprobe Models
® when filter is out of position. Lever Extension SmartKey handle WARNING: For use with IRIDEX laser systems only. 13103-EN Rev K IRIDEX EndoProbe Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual ®... -
Page 11: Connecting The Components
Connecting the Components NOTE: Use the eye safety filter appropriate for the laser in use. If you are using a two-position eye safety filter, you may need to configure your laser before installing the filter. Follow the configuration instructions in your laser manual. WARNINGS: If you are using a beam splitter on your operating microscope, you must install the fixed eye safety filter before installing the beam splitter. - Page 12 If the delivery device is single-use, dispose of it properly. Otherwise, inspect and clean the delivery device(s) as instructed in your delivery device manual(s). If a contact lens was used, handle the lens according to the manufacturer’s instructions. 13103-EN Rev K IRIDEX EndoProbe Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual ®...
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Page 13: 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 •... - Page 14 View is blocked or partially Set magnification to 10X or more. blocked by OMA (OMA* only) *Operating microscope adapter compatible with IRIDEX IQ 810 and SLx Systems. 13103-EN Rev K IRIDEX EndoProbe Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual...
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Page 15: Maintenance
Maintenance These probes are single-use, disposable delivery devices. The device is intended for use on one patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected/ sterilized) and used on another patient. No reuse processes have been validated by the manufacturer. The reuse of a single-use medical device can compromise the safety and health of patients, users or third parties. -
Page 16: 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. For additional information, refer to ANSI Z136.1, ANSI Z136.3, or European Standard IEC 60825-1. 13103-EN Rev K IRIDEX EndoProbe Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual ®... -
Page 17: Safety Compliance
Safety Compliance Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007. CE-marked devices comply with all requirements of the European Medical Device Directive MDD 93/42/EEC. Illuminating Probe Specifications The following information on the illumination capabilities of this device is provided in accordance with ISO 15752, Section 6.2. -
Page 18: Symbols (As Applicable)
Electromagnetic Read Information Radiation Remote Control Remote Interlock Serial Number Single Use Standby Treat Waste Electrical Type B Equipment and Electronic Pattern is Activated Equipment (WEEE) 13103-EN Rev K IRIDEX EndoProbe Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual ®... - Page 19 Protections Against Protections Against Temperature Splash Water IPX4 IPX8 Continuous Limitations Coming from all Immersion Directions Refer to Instruction Initial Power Interval between Manual/Booklet (PowerStep) Groups (in blue) Number of Pulses Number of Steps Power (MicroPulse) (Group) (PowerStep) Power Increment Parameter Power Increment (PowerStep)
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