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Contents

13102C-EN

CLINICAL & SAFETY · 23

C

LINICAL

A

PPLICATIONS

· 23

Indications for clinical use · 23
Contraindication · 23
Recommended procedure for clinical use · 23

Panretinal photocoagulation (outpatient) · 23
Panretinal photocoagulation (operating room) · 24
Sealing treatment · 24
Treating patients who have a gas-filled eye · 24
Treating patients with recent ocular surgery · 24
Treating patients with a localized vitreous hemorrhage · 25
Treating patients with a scleral buckle · 25
Treating patients with small pupils · 25

Treatment considerations · 25

Positioning · 25
Using the scleral depressor · 26
Moving the spot · 26
Positioning the condensing lens · 26
Power density and spot size · 27
Choosing anesthesia · 27
Power and duration · 28
Repeat interval · 29
Red aiming and treatment beams · 29

S

AFETY

· 30

Preventing unintended exposure of laser energy · 30
Preventing unauthorized use of the system · 30
Ensuring safe operation · 30
Preventing reflection hazards · 30
Preventing fire and explosion hazards · 30
Ensuring ocular protection · 31

Protection for the physician · 31
Protection for all persons in the treatment room — laser safety eyewear

requirements · 31

Regulatory compliance safety features · 31

Eye safety filter · 31
Laser emission indicator · 31
Safety interlock · 31
Location of regulatory compliance and other system labels · 32

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Содержание TruFocus LIO+

Страница 1: ...Operator Manual IRIDEX 13102 EN Revision C TruFocus LIO ...

Страница 2: ...published with the original manual This manual is provided for instructional use and while every effort has been made to ensure that the information is accurate the text illustrations and specifications are subject to change without notice The IRIDEX logo IRIS Medical OcuLight and SmartKey are registered trademarks of IRIDEX Corporation TruFocus and IQ 810 are trademarks of IRIDEX Corporation IRID...

Страница 3: ...es 3 Large Spot 810 nm Wavelength TruFocus LIO 3 Console compatibility 3 Treatment wavelength 3 Laser spot size 3 Headset styles 3 WARRANTY AND SERVICE 4 Warranty 4 Product registration 4 Service and technical support 4 OPERATION 5 ABOUT THE COMPONENTS 5 TruFocus LIO 6 Cable assembly 6 Fiber optic cable 6 Illumination cable 6 Zero diopter lenses 6 CONNECTING THE COMPONENTS 7 Using the TruFocus LIO...

Страница 4: ...11 Positioning the white illumination beam 12 Positioning the red aiming beam 12 USING THE SPECIAL FUNCTION CONTROLS 13 Selecting the illumination filter 13 Selecting the illumination aperture size 13 BEFORE TREATING PATIENTS 14 TREATING A PATIENT 15 CONCLUDING PATIENT TREATMENT 16 TROUBLESHOOTING 17 MAINTENANCE 21 INSPECTING AND CLEANING 21 Routine care 21 Inspect the TruFocus LIO 21 Clean the fi...

Страница 5: ...ng 25 Using the scleral depressor 26 Moving the spot 26 Positioning the condensing lens 26 Power density and spot size 27 Choosing anesthesia 27 Power and duration 28 Repeat interval 29 Red aiming and treatment beams 29 SAFETY 30 Preventing unintended exposure of laser energy 30 Preventing unauthorized use of the system 30 Ensuring safe operation 30 Preventing reflection hazards 30 Preventing fire...

Страница 6: ...iv TruFocus LIO Operator Manual 13102C EN ...

Страница 7: ...iew of the developing lesion The exclusive TruFocus optical system provides consistent treatment results by offering the capability of changing working distance and lens position without changing laser focus adjustments Its unique controls allow you to move the laser and the illumination field separately or both together Fully enclosed optics prevent misalignment and contamination CAUTION Federal ...

Страница 8: ...ion 3 2 and above OcuLight GLx version 3 3 and above OcuLight TX version 4 0 and above OcuLight SLx version 4 1 and above OcuLight OR version 2 0 and above IQ 810 version 1 0 and above Treatment wavelength Diode Pumped Frequency Doubled Solid State 532 nm Laser Diode 810 nm Laser spot size 360 µm spot at the retina using a 20 D lens Headset styles Cap strap Standard Spot 810 nm Wavelength TruFocus...

Страница 9: ...he retina using a 20 D lens Headset styles Cap strap Large Spot 810 nm Wavelength TruFocus LIO Console compatibility OcuLight SL with optional large spot upgrade OcuLight SLx IQ 810 Treatment wavelength Laser Diode 810 nm Laser spot size 1 3 mm spot at the retina using a 20 D lens Headset styles Cap strap ...

Страница 10: ...IO carries a standard factory warranty Product registration Please complete and forward to us the enclosed product registration card 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 ...

Страница 11: ...no damage occurred during transit Along with this manual you should have the TruFocus LIO zero diopter lenses and a spare halogen bulb NOTE Should you notice problems with your order please contact your local IRIDEX Technical Support representative immediately Made in 810 TruFocus LIO Standard Spot 810 nm wavelength shown Halogen bulb Zero diopter lenses Fiber optic cable Illumination cable Cable ...

Страница 12: ...usly Identification of wavelength engraved on fiber adapter cap Cable assembly Fiber optic cable The fiber optic cable and connector is part of the cable assembly attached to the TruFocus LIO The fiber optic cable transmits the laser light from the console to the TruFocus LIO optics Illumination cable The illumination cable and connector is also part of the cable assembly The illumination power su...

Страница 13: ...n the treatment room WARNING Do not use the TruFocus LIO with any laser system other than an IRIDEX console Such use may void any product warranties and jeopardize the safety of the patient yourself and others in the treatment room ms LIO Counter Reset Σn 0 Σn LIO Laser Aperture At End Of Fiber Optic SmartKey Carefully insert and finger tighten the connector into the console fiber optic port until...

Страница 14: ...r into the console TruFocus LIO receptacle Press firmly to seat the connector Using the TruFocus LIO as a diagnostic device Connect the illumination connector to the console LIO Counter Reset Σn 0 Σn LIO Laser Aperture At End Of Fiber Optic SmartKey LIO Counter Reset Σn 0 Σn LIO Laser Aperture At End Of Fiber Optic SmartKey ...

Страница 15: ...e knob clockwise until the TruFocus LIO fits securely Adjusting the height Turn the knob at the top of the headpiece until the headband is comfortably positioned Adjusting the optical unit While holding the optical unit loosen the adjustment knob This enables you to move the optical unit up and down in and out and tilt it forward and backward Make the necessary adjustments to obtain a comfortable ...

Страница 16: ...pushing the finger tabs under each eyepiece interpupillary distance adjustment Place a viewing target 36 cm 14 inches away for the TruFocus LIO Close one eye Adjust the separation until you see the entire target Do the same with the other eye The eyepieces are properly adjusted when each eye sees the entire target ...

Страница 17: ...ing the white illumination beam intensity Use the illumination brightness control on the console to adjust the intensity of the white illumination beam formation ms ms Pilot Aiming LIO Σn Laser Aperture At End Of Fiber Optic T Adjusting the aiming beam intensity Use the Pilot Aiming adjustment control on the console to adjust the intensity of the red aiming beam Use the lowest setting that still a...

Страница 18: ...n beam appears to be displaced to one side move both interpupillary distance adjustment finger tabs in the same direction until the light is centered Positioning the red aiming beam Use the aiming beam treatment beam adjustment control to position the red aiming beam within the field of view The console delivers the treatment beam to the site illuminated Made in IRIS Medical Made in USA ...

Страница 19: ...o select red free cobalt or white light illumination White light is most frequently used during laser treatment Selecting the illumination aperture size Use the illumination aperture control to select a small medium or large illumination aperture The large aperture is most frequently used during laser treatment IRIS Medical 810 nm Made in USA ...

Страница 20: ... Post the laser warning sign outside the treatment room door Before Treating Patients REFERENCE Read the Clinical and Safety sections of your console manual and this manual before using the TruFocusLIO REFERENCE See the Connecting the Components sections of your console manual and this manual for connection instructions ...

Страница 21: ...nt beam 14 When you do not require the treatment beam remove your foot from the footswitch and place the console in Standby mode REFERENCE See the Using the Control Panel section of your console manual for instructions on using the treatment controls and displays REFERENCE See the Adjusting the Fit of the TruFocus LIO and Adjusting the Illumination Light and Aiming Beam sections of this manual for...

Страница 22: ... the fiber optic port and the connector with the protective caps 5 Disconnect the illumination light input connector from the console 6 If desired inspect clean and store the aspheric lens in accordance with your manufacturer s instructions 7 If desired inspect clean and store the TruFocus LIO 8 If desired inspect clean and store the console 9 If desired remove the laser warning sign from the trea...

Страница 23: ...on Inadequate or no aiming beam Ensure that the TruFocus LIO is properly connected to the console Ensure that the console is in Treat mode Turn theAiming Beam control fully clockwise Ensure that the fiber 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 Techn...

Страница 24: ...e if necessary Illumination light is too dim Ensure that the special function control is not between detents and that the large aperture is selected Adjust the console illumination intensity control The aiming beam is large or out of focus on the patient s retina Readjust your working distance between the TruFocus LIO headset and the examination lens The aiming beam should be sharply defined and a...

Страница 25: ...patient s iris Adjust the laser beam in the illuminated field The laser treatment parameters may be too close to the tissue response threshold for consistent response Increase the laser Power and or exposure Duration Alternatively laser power density may be increased by selecting a lower diopter examination lens to reduce the laser spot size on the retina This will also alter your field of view Pr...

Страница 26: ...20 TruFocus LIO Operator Manual 13102C EN ...

Страница 27: ...ris and damage Clean the fiber optic connector If needed clean the fiber optic connector using a cotton swab moistened with 100 methanol preferred or 100 isopropyl alcohol Place the protective cap on the fiber optic connector Clean the external surfaces Wipe headpiece surfaces with a soft cloth dampened with a mild detergent Clean the hand held aspheric lens Follow the manufacturer s instructions ...

Страница 28: ...e the burned out illumination lamp 3 Insert an identical type of lamp aligning the key on the lamp base with the slot in the TruFocus LIO 4 Screw on the retaining cap CAUTION Do not touch the lamp s glass envelope Remove any fingerprints from the lamp envelope with a cotton tipped swab moistened with methanol ...

Страница 29: ... in clinical papers before using theTruFocus LIO delivery device A Reference Catalog of clinical papers and presentations is available through IRIDEX Marketing Panretinal photocoagulation outpatient Slit lamp delivery is typically used to treat the posterior 80 of the retina with the use of mirrored contact lenses The most peripheral 20 of the retina can more easily be seen and treated with sclera...

Страница 30: ...yled contact lenses used at the slit lamp Concurrent scleral depression is often helpful to flatten pockets of subretinal fluid near the retinal tear or detachment using sealing treatment Treating patients who have a gas filled eye Postoperatively patients whose eyes harbor gas bubbles can be quite difficult to treat because of troublesome reflections at the slit lamp The TruFocus LIO allows posit...

Страница 31: ... and particularly those with media opacities are difficult to treat with a slit lamp Better visualization through a small pupil may be obtained with theTruFocus LIO and an appropriate choice of auxiliary lens Treatment considerations Positioning Place the patient in a supine position Position your head T ruFocus LIO approximately 37 to 50 cm 15 to 20 in from the patient s eye Direct the white illu...

Страница 32: ...e spot To minimize neck fatigue move the eye with the depressor while holding the TruFocus LIO steady to move the spot or shift the handheld condensing lens Because the plus lens has a large amount of base in prism you can move the laser spot with the motion of the handheld lens To achieve the largest spot movement move your head to the desired position Positioning the condensing lens Treat within...

Страница 33: ... reflex The patient is not sedated and maintains the ability to change positions if necessary during treatment Retrobulbar anesthesia may be desirable when treating the anterior half of the eye It is often more painful treating anteriorly compared to treating the posterior retina The disadvantage however is the removal of the patient s ability to move the eye is various directions Scleral depressi...

Страница 34: ...spot size on retina Myopic eye 70D 1100 x 20D 70D 315µm spot size on retina Hyperopic eye 50D 1100 x 20D 50D 440µm spot size on retina This is only an example The power of myopic or hyperopic eyes vary by patient Positioning the aspheric lens 55 mm from an emmetropic eye should produce a magnified aerial image of the fundus A myopic eye requires the examination lens to be slightly closer the hyper...

Страница 35: ...ed pockets of subretinal fluid that can affect size and shape of the burns and can cause additional problems The time required between pulses should allow enough time for the surgeon to move the laser beam to another location Laser spot placement that is done too rapidly can lead to inaccuracies in placement of the lesions A repeat interval of 300 ms to 500 ms seems ideal Red aiming and treatment ...

Страница 36: ...LIO Preventing unauthorized use of the system This device is intended for use only by you the qualified physician The applicability of the equipment and treatment techniques selected is your sole responsibility When you leave the console and TruFocus LIO unattended turn off the console and remove the key to prevent unauthorized use Ensuring safe operation Do not use the TruFocus LIO if you suspect...

Страница 37: ...opriate performance standards as specified in Annex II of the Medical Device Directive MDD 93 42 EEC 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 greenTreat light on the console provides a visible warning that laser radiation may be emitted from the TruFoc...

Страница 38: ...32 TruFocus LIO Operator Manual 13102C EN 0344 L XXXX LASER APERTURE LASER APERTURE LASER APERTURE 0344 Laser aperture labels CE label LASER APERTURE LASER APERTURE LASER APERTURE 0344 ...

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