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13105-EN Rev E

Safety and Compliance 11

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.

Feature

Function

Eye safety filter

The eye safety filter ensures that all laser radiation returned to the physician and

any co-observers is below Class I limits.

Laser emission indicator Illumination of the green Treat light on the laser provides a visible warning that laser

radiation may be emitted.

Safety interlock

The delivery device’s protective housing and the laser fiber connector cannot

be opened without the use of special tools. The delivery device is also safety-

interlocked at the fiber-optic port on the laser.

Содержание G-Probe

Страница 1: ...G Probe Device Operator Manual ...

Страница 2: ...dical OcuLight EndoProbe and SmartKey are registered trademarks BriteLight CW Pulse DioPexy EasyFit EasyView FiberCheck G Probe IQ 532 IQ 577 IQ 810 LongPulse MicroPulse MilliPulse OtoProbe PowerStep Symphony TruFocus and TruView are trademarks of IRIDEX Corporation All other trademarks are the property of their respective holders ...

Страница 3: ...ontact Information 4 2 Operation 6 About the Components 6 Connecting the G Probe 6 Treating Patients 7 3 Troubleshooting 8 General Problems 8 4 Maintenance 9 5 Safety and Compliance 10 Protection for the Physician 10 Protection for All Treatment Room Personnel 10 Safety Compliance 11 Symbols As Applicable 12 G Probe Specifications 13 Contents 13105 EN Rev E iii ...

Страница 4: ...Contents iv 13105 EN Rev E ...

Страница 5: ... filtration surgery Contraindications Any situation where the target tissue cannot be adequately visualized or stabilized Do not treat albino patients who have no pigmentation Clinical Warnings Excessive treatment power may cause ciliary body hemorrhage Excessive power delivered at short pulse durations may result in choroidal hemorrhage Excessive energy may cause peripheral lens damage Presence o...

Страница 6: ... applications one half the width of the G Probe tip by aligning the trailing edge of the probe tip on the center of the indentation of the previous treatment lesion Deliver laser application to 18 20 treatment sites over a 270º arc as shown Treat the right eye from the 10 30 position clockwise to the 7 30 position unless the area is scarred from previous operations Treat the left eye from the 4 30...

Страница 7: ...s that deliver the laser beams with or without laser safety eyewear Never look directly into the laser light source or at laser light scattered from bright reflective surfaces Avoid directing the treatment beam at highly reflective surfaces such as metal instruments Ensure that all personnel in the treatment room are wearing the appropriate laser safety eyewear Never substitute prescription eyewea...

Страница 8: ...e State in which he she practices to use or order the use of the device Use of controls or adjustments or performing of procedures other than those specified herein may result in hazardous radiation exposure Do not operate the equipment in the presence of flammables or explosives such as volatile anesthetics alcohol and surgical preparation solutions Turn off the laser before inspecting any delive...

Страница 9: ...yone other than certified IRIDEX service personnel 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 ...

Страница 10: ...gh its fiber optic tip The probe tip allows precise placement around the circumference of the limbus Check the G Probe carefully before use to ensure that no damage occurred during transit NOTE Ensure eye safety Use 810 nm laser safety glasses or eye safety filter An 810 nm filter may be part of an SLA LIO or operating microscope system Connecting the G Probe G Probe handle Probe tip Fiber optic c...

Страница 11: ...atment 6 Ensure that all ancillary personnel in the treatment room are wearing the appropriate laser safety eyewear 7 Select Treat mode 8 Position the aiming beam on the treatment site 9 Focus or adjust the delivery device as applicable 10 Press the footswitch to deliver the treatment beam To conclude patient treatment 1 Select Standby mode 2 Record the number of exposures and any other treatment ...

Страница 12: ...t mode Turn the aiming beam control fully clockwise 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 Verify that the aiming beam is visi...

Страница 13: ...nd 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 Reuse risks the introduction of contaminants and 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 r...

Страница 14: ... user s authority 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 and Laser Indirect Ophthalmoscope LIO for endophotocoagulation or for Operating Microscope Adapter OMA use a separate discrete eye safety filter assembly ...

Страница 15: ...on Eye safety filter The eye safety filter ensures that all laser radiation returned to the physician and any co observers is below Class I limits Laser emission indicator Illumination of the green Treat light on the laser provides a visible warning that laser radiation may be emitted Safety interlock The delivery device s protective housing and the laser fiber connector cannot be opened without t...

Страница 16: ...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 Interlock Serial Number Sin...

Страница 17: ...lses 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 G Probe Specifications Specification Definition Probes Standard handle 10 30 cm 4 05 in Laser compatibility OcuLight SL OcuLight SLx IQ 81...

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