Iridex EndoProbe Скачать руководство пользователя страница 9 | Manualshive

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3

Introduction

13103F-EN

Warranty

The probes are single-use devices that are warranted against
manufacturing defects.

Service and technical support

IRIDEX has established 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

The probes are intended

for single-use only.

WARNING

If these single-use devices

are reused, performance,

safety, and efficacy cannot

be guaranteed.

Warranty and Service

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Содержание EndoProbe

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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