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1 Introduction ......................................................................................... 1

Indications for Use .........................................................................................................1

Precautions .....................................................................................................................1

Recommended Procedure ............................................................................................1

Power and Duration ......................................................................................................1

Warnings and Cautions ................................................................................................2

References .......................................................................................................................3

Compatible IRIDEX Lasers...........................................................................................4

IRIDEX Corporation Contact Information .................................................................4

2 Operation ............................................................................................. 5

About the Components .................................................................................................5

EndoProbe Models ........................................................................................................5

OtoProbe Models ...........................................................................................................6

FlexFiber Models ...........................................................................................................6

Eye Safety Filters ............................................................................................................6

Connecting the Components .......................................................................................7

Laser Spot Size ...............................................................................................................7

Treating Patients ............................................................................................................7

3 Troubleshooting ................................................................................... 9

General Problems ...........................................................................................................9

4 Maintenance ....................................................................................... 11

Cleaning Optical Components...................................................................................11

5 Safety and Compliance ...................................................................... 12

Protection for the Physician .......................................................................................12

Protection for All Treatment Room Personnel .........................................................12

Safety Compliance .......................................................................................................13

Illuminating Probe Specifications .............................................................................13

Illumination Testing ....................................................................................................13

Symbols (As Applicable) ............................................................................................14

Contents

13103-EN Rev K

iii

Содержание EndoProbe Series

Страница 1: ...EndoProbe Handpiece OtoProbe Device and FlexFiber Device Operator Manual ...

Страница 2: ...al OcuLight EndoProbe FlexFiber and SmartKey are registered trademarks 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 ...

Страница 3: ...ls 5 OtoProbe Models 6 FlexFiber Models 6 Eye Safety Filters 6 Connecting the Components 7 Laser Spot Size 7 Treating Patients 7 3 Troubleshooting 9 General Problems 9 4 Maintenance 11 Cleaning Optical Components 11 5 Safety and Compliance 12 Protection for the Physician 12 Protection for All Treatment Room Personnel 12 Safety Compliance 13 Illuminating Probe Specifications 13 Illumination Testing...

Страница 4: ...Contents iv 13103 EN Rev K ...

Страница 5: ...seous tissue in the medical specialty of Ear Nose and Throat ENT surgery The OtoProbe is cleared for use for the particular indications of the compatible laser system to which it is attached The FlexFiber Device is intended for use in treatment of soft tissue vascular lesions of the airway and larynx The FlexFiber is cleared for use for the particular indications of the compatible laser system to ...

Страница 6: ...earing the appropriate laser safety eyewear Never substitute prescription eyewear for laser safety eyewear Always handle the fiber optic cables with extreme care Do not coil the cable into a diameter less than 15 cm 6 in Turn off the laser before inspecting any delivery device components Keep the protective cap over the fiber optic connector when the delivery device is not in use Follow standard f...

Страница 7: ...heal tubes from laser radiation Ignition or perforation of endotracheal tubes by the laser beam could result in serious or fatal patient complications References Reference material and additional information regarding laser safety and the prevention of endotracheal fires may be obtained from the following U S sources ANSI Z136 3 The Safe Use of Lasers in Health Care Facilities American National St...

Страница 8: ...cal Support 650 962 8100 techsupport iridex com Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands 2797 Warranty and Service This device carries a standard factory warranty This warranty is void if service is attempted by anyone other than certified IRIDEX service personnel NOTE This Warranty and Service statement is subject to the Disclaimer of Warranties Limitation of Remedy and ...

Страница 9: ...sit Ensure that the appropriate eye safety filter is installed prior to using a probe EndoProbe Models Model Description Standard straight or angled Provides intraocular laser delivery Illuminating Provides light illumination and laser delivery Stepped 45 angled Provides laser delivery probe designed for use with a trochar Adjustable and Intuitive Provides laser delivery probe designed for manual ...

Страница 10: ...umber Description 15702 200 μm Laser Fiber 15703 300 μm Laser Fiber 15704 400 μm Laser Fiber 15706 600 μm Laser Fiber Eye Safety Filters Eye Safety Filter 532 nm 577 nm 810 nm Fixed Two Position Fixed Eye Safety Filter Eye protection for physician is fixed and always in place Two Position Eye Safety Filter Filter position is adjusted manually SmartKey provides feedback to laser to ensure no laser ...

Страница 11: ...er exposure or injury to you your patient or others in the treatment room CAUTION Gently finger tighten the connector to the port Do not overtighten Laser Spot Size To change the spot size move the probe farther from or closer to the target Treating Patients Before treating a patient Ensure that the eye safety filter as appropriate is properly installed and that the SmartKey if used is selected En...

Страница 12: ...he footswitch to deliver the treatment beam To conclude patient treatment 1 Select Standby mode 2 Record the number of exposures and any other treatment parameters 3 Turn off the laser and remove the key 4 Collect the safety eyewear 5 Remove the warning sign from the treatment room door 6 Disconnect the delivery device s 7 Disconnect the SmartKey if used 8 If the delivery device is single use disp...

Страница 13: ...am Verify that the remote interlock has not been activated Verify that the aiming beam is visible Verify that the fiber switch is in the correct position for the laser system and wavelength you are using Verify that the eye safety filter is in the closed position If there is still no treatment beam contact your local IRIDEX Technical Support representative No illumination light LIO only Verify tha...

Страница 14: ...ers may be too close to the tissue response threshold for consistent response Increase the laser power and or exposure duration or select a different lens Does not fit on the mounting plate OMA only Inspect and clean the mounting plate Verify that the mounting plate corresponds to your microscope Laser and viewing systems are not focussed at the same point OMA only Verify installation of a 175 mm ...

Страница 15: ...or microbes and may lead to patient injury and or infection Store probe package under normal storage conditions in a dry clean well ventilated area at room temperature between 15º 25ºC 59 77ºF Cleaning Optical Components 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 gently with the s...

Страница 16: ...ty to operate the equipment Protection for the Physician Eye safety filters protect the physician from backscattered treatment laser light Integral eye safety filters are permanently installed in every compatible Slit Lamp Adapter SLA and Laser Indirect Ophthalmoscope LIO For endophotocoagulation or for Operating Microscope Adapter OMA use a separate discrete eye safety filter assembly must be ins...

Страница 17: ...SO 15752 Section 6 2 Feature Specification Effective Aperture 0 5 mm Numerical Aperture 0 5 0 8 Light Guide Materials PMMA or Silica Illumination Testing The following information on the illumination capabilities of this device is provided in accordance with ISO 15752 Section 4 4 2 Measurement of the aphakic weighted irradiance of an illuminating EndoProbe may be made under sterile conditions Foll...

Страница 18: ...entative Expiration Date Footswitch Footswitch In Footswitch Out Fuse Gauge Protective Earth Ground Illuminating Probe Decrease Increase Interval Interval with MicroPulse Laser Aperture at End of Fiber Laser Warning Illumination LOT Manufacturer Date of manufacture Off On Part Number Power Pulse Count Pulse Count Reset No ionizing Electromagnetic Radiation Read Information Remote Control Remote In...

Страница 19: ...rsion Refer to Instruction Manual Booklet in blue Initial Power PowerStep Interval between Groups Number of Pulses Group Number of Steps PowerStep Power MicroPulse Power Increment Power Increment PowerStep Parameter is Locked USB Port Indicators Laser Firing Laser Preparing Speaker Screen System Brightness Latex Free Prescription Warning Replace with fuses as indicated ...

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