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EndoProbe and ENT Probe Operator Manual

13103F-EN

Sterile pouch label

Sample of an EndoProbe sterile pouch label

WARNING

Do not use if

package is

damaged.

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Summary of Contents for EndoProbe

Page 1: ...EndoProbe and OtoProbe Operator Manual IRIDEX 13103 EN Revision F...

Page 2: ...e to ensure that the information is accurate the text illustrations and specifications are subject to change without notice The IRIDEX logo IRIS Medical OcuLight IQ 810 EndoProbe and SmartKey are regi...

Page 3: ...Kit components for the OcuLight GL GLx TX 5 EndoProbe Starter Kit components for the OcuLight SL SLx 5 Component descriptions 5 EndoProbe 5 Standard Probes 6 Specialty Probes Illuminating 7 Active Asp...

Page 4: ...a fixed eye safety filter insert the SmartKey emulation plug 17 Connect the fiber optic 18 To IRIDEX lasers 19 To non IRIDEX lasers 19 If applicable connect the EndoProbe to an illumination source 20...

Page 5: ...rized use of the system 33 Ensuring safe operation 33 Preventing reflection hazards 33 Preventing fire and explosion hazards 33 Ensuring ocular protection 34 Protection for the physician 34 Protection...

Page 6: ...iv EndoProbe and OtoProbe Operator Manual 13103F EN...

Page 7: ...nterior of the eye The ENT Probe is used to perform otolaryngological procedures and is offered in short and long angled styles The OtoProbe is a member of the ENT Probe family The EndoProbe handpiece...

Page 8: ...uminator light guide materials PMMA acrylic plastic polymer or fused silica Illumination testing In accordance with ISO 15752 Section 4 4 2 the following information specific to the illumination capab...

Page 9: ...lished an efficient process to support its installations worldwide Should you require assistance please contact your local IRIDEX Technical Support representative or our corporate headquarters NOTE Th...

Page 10: ...4 EndoProbe and ENT Probe Operator Manual 13103F EN...

Page 11: ...Probe style s you ordered an IRIDEX fixed eye safety filter labeled for use at the 810 nm wavelength and four pairs of safety glasses if applicable Component descriptions EndoProbe Each EndoProbe deli...

Page 12: ...EndoProbe and ENT Probe Operator Manual 13103F EN 6 Standard The tapered EndoProbe makes it easier to insert and extract at the sclerostomy site IRIDEX IRIDEX...

Page 13: ...llumination connector allows you to use the EndoProbe with a variety of ophthalmic light sources such as Bausch Lomb and Alcon An adapter may be required for use with some illuminating light sources C...

Page 14: ...l the amount of fluid that is aspirated Aspiration occurs through the positive pressure within the eye IRIDEX IRIDEX Active Aspirating The active aspirating EndoProbe available in straight and angled...

Page 15: ...03F EN 9 Stepped 45 Angled The stepped EndoProbe handpieces offer a smooth gently tapered needle which permits the angled 45 tip to be inserted through straight cannulas for full coverage of the perip...

Page 16: ...Operator Manual 13103F EN 10 ENT Probes The short angled OtoProbe offers better visibility when viewing the tissue around the needle tip The long angled OtoProbe offers a longer straight needle for ea...

Page 17: ...oving and has specially coated lenses that allow for a clear unobstructed view of the retina SmartKey emulation plug available for OcuLight GL GLx OR consoles The SmartKey emulation plug which comes w...

Page 18: ...rovides electronic communication from the eye safety filter to the console indicating when the filter is in the viewing path and when it is not The extension handle provides easier access to the eye s...

Page 19: ...from 810 nm and 532 nm laser light install both IRIDEX eye safety filters into your microscope Remove the binocular tube from the operating microscope Loosen the thumbscrew that holds the binocular t...

Page 20: ...eat Interval control clockwise until you see 7 in the Counter display Release the Counter Reset button Your version of firmware is shown in the status display 3 If you have a compatible version of fir...

Page 21: ...ll the eye safety filter Install the eye safety filter on the microscope and tighten the thumbscrew to secure 16 6 16 6 16 6 16 6 Installation of a fixed eye safety filter Installation of a two positi...

Page 22: ...anual 13103F EN 16 If using a two position eye safety filter insert the SmartKey Insert the SmartKey into the SmartKey port on the OcuLight GL GLx TX or OR console SmartKey Laser Aperture At End Of Fi...

Page 23: ...using an OcuLight GL GLx or OcuLight OR console and a fixed eye safety filter insert the SmartKey emulation plug Insert the SmartKey emulation plug into the laser console SmartKey port SmartKey At End...

Page 24: ...edures for removal and connection of delivery systems in a sterile environment Remove the probe from the sterile pouch and inspect the fiber optic cable for damage Remove the protective cap from the p...

Page 25: ...r into the console fiber optic port until secure If the probe is properly connected when you turn on the console EndoProbe displays on the console status panel To non IRIDEX lasers Remove the protecti...

Page 26: ...uminating EndoProbe insert the illumination fiber connector into the appropriate light source port An illumination source adapter accessory is available for use with certain light sources such as Grie...

Page 27: ...ensity is not linear Halving the spot size quadruples the power density The physician must understand the relationship between spot size laser power power density and laser tissue interaction WARNING...

Page 28: ...ing the Aspiration Passive During normal operation cover the hole on the handle with your finger To aspirate lift your finger off of the hole Finger port uncovered Finger port covered Active Regulate...

Page 29: ...osition eye safety filter EndoProbe displays on the OcuLight GL GLx console status panel when the filter is closed ENT Probe displays on the OcuLight OR Opening the filter When the two position eye sa...

Page 30: ...he Using the Control Panel section of your console manual for instructions on using the treatment controls and displays WARNING Do not use a probe whose pouch arrived opened or damaged Before Treating...

Page 31: ...sed REFERENCE See the Inspecting and Cleaning sections of your console manual and this manual for cleaning and storage instructions Treating a Patient 1 Set the treatment parameters 2 Position the pat...

Page 32: ...from the console fiber optic port Cover the fiber optic port with the protective cap 5 Cut the probe in half with scissors so it cannot be used again Discard both probe pieces in accordance with your...

Page 33: ...optic connector is not damaged If possible connect another IRIS Medical delivery device and place the console in Treat mode If the aiming beam is still not visible contact your local IRIDEX Technical...

Page 34: ...Key Ensure that the SmartKey is properly inserted Eye Safety Filter Ensure that the IRIS Medical eye safety filter is properly installed Green Safety Filter Close the eye safety filter to permit laser...

Page 35: ...UTION Follow standard facility procedures for the handling of biohazardous material after each probe use The probe is a single use disposable delivery device When finished with a procedure dispose of...

Page 36: ...ilter To clean the eye safety filter 1 Wrap a lens tissue around one end of a cotton tipped swab 2 Place several drops of 100 ethanol 100 methanol or high grade acetone on the tissue 3 Wipe the lens g...

Page 37: ...during ENT procedures Indications include but are not limited to incision excision coagulation and vaporization of soft and fibrous tissue including osseous tissue The IRIDEX OtoProbe is indicated for...

Page 38: ...y watts cm2 is laser power divided by the area of the illuminated spot therefore you can increase power density either by increasing the laser power or by decreasing the spot size Power and duration I...

Page 39: ...ng instruments whenever possible Be careful not to direct the laser beam at unintended objects Preventing fire and explosion hazards Do not operate the console and probe in the presence of flammables...

Page 40: ...for safety eyewear for others in the treatment room based on the MPE Nominal Ocular Hazard Area NOHA and Nominal Ocular Hazard Distance NOHD for the probe and the console used and the configuration o...

Page 41: ...e eye safety filter ensures that all laser radiation returned to the physician and any co observers is below the Class I limit Laser emission indicator Illumination of the green Treat light on the con...

Page 42: ...36 EndoProbe and ENT Probe Operator Manual 13103F EN Sterile pouch label Sample of an EndoProbe sterile pouch label WARNING Do not use if package is damaged...

Page 43: ...37 Clinical Safety 13103F EN Sample of an ENT sterile pouch label...

Page 44: ...38 EndoProbe and ENT Probe Operator Manual 13103F EN...

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