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17

  IRIDEX

®

 LIO Plus Operator Manual 

88046-EN Rev A

Guidance and Manufacturer’s Declaration - Immunity

This laser system (console and accessories) is intended for use in the electromagnetic environment specified 

below. The customer or the user of the laser system should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic 

Environment — 

Guidance

Electrostatic 

discharge (ESD) 

IEC 61000-4-2

±6 kV contact 
±8 kV air 

±6 kV contact 
±8 kV air 

Floors should be wood, 

concrete, or ceramic tile. 

If floors are covered with 

synthetic material, the 

relative humidity should 

be at least 30%.

Electrical fast 

transient/burst 

IEC 61000-4-4

±2 kV for power supply lines
±1 kV for input/output lines

±2 kV for power supply lines
Not Applicable

Mains power quality 

should be that of a typical 

commercial or hospital 

environment.

Surge
IEC 61000-4-5

±1 kV differential mode
±2 kV common mode

±1 kV differential mode
±2 kV common mode

Mains power quality 

should be that of a typical 

commercial or hospital 

environment.

Voltage dips, short 

interruptions and 

voltage variations 

on power supply 

input lines
IEC 61000-4-11

<5% U

(>95% dip in U

T

) for 0.5 cycle 

40% U

(60% dip in U

T

) for 5 cycles

70% U

(30% dip in U

T

) for 25 cycles

<5% U

(>95% dip in U

T

) for 5 cycles

<5% U

(>95% dip in U

T

) for 0.5 cycle 

40% U

(60% dip in U

T

) for 5 cycles

70% U

(30% dip in U

T

) for 25 cycles

<5% U

(>95% dip in U

T

) for 5 cycles

Mains power quality 

should be that of a typical 

commercial or hospital 

environment. If the user 

or the laser system 

requires continued 

operation during power 

mains interruptions, it is 

recommended that the 

laser system be powered 

from an uninterruptible 

power supply or 

a battery.

(50/60 Hz) 

magnetic field
IEC 61000-4-8

3 A/m

3 A/m

Power frequency 

magnetic fields should 

be at levels characteristic 

of a typical location in 

a typical commercial or 

hospital environment.

NOTE

: U

T

 is the AC mains voltage prior to application of the test level.

Summary of Contents for LIO Plus

Page 1: ...IRIDEX LIO Plus Operator Manual ...

Page 2: ...ght EndoProbe SmartKey MicroPulse Cyclo G6 and MicroPulse P3 are registered trademarks BriteLight CW Pulse DioPexy EasyFit EasyView FiberCheck G Probe IQ 532 IQ 577 IQ 810 LongPulse MilliPulse OtoProbe PowerStep Symphony TruFocus and TruView are trademarks of IRIDEX Corporation All other trademarks are the property of their respective holders ...

Page 3: ...ce 6 Instructions to Treat a Patient 7 3 Troubleshooting 8 General Problems 8 4 Maintenance 9 Inspecting the LIO 9 Cleaning the Fiber Optic Connector 9 Cleaning the External Surfaces 9 Cleaning the Optical Components 9 Changing the Illumination Lamp 10 5 Service 10 6 Safety and Compliance 11 Protection for the Physician 11 Protection for All Treatment Room Personnel 11 Safety Compliance 12 Labels ...

Page 4: ...on Contraindications The IRIDEX LIO Plus is not indicated for cases involving laser photocoagulation within the arcades Do not treat albino patients who have no pigmentation Factors Affecting Spot Size The refractive index of media in the eye Working distance The smallest spot is obtained when the laser spot is at its focus point on the image plane Refractive status of the eye The laser spot size ...

Page 5: ...r exposure or injury to yourself your patient or others in the treatment room Always verify that the delivery device is properly connected to the laser An improper connection may result in an inadvertent secondary laser beam Severe eye or tissue damage could occur Do not use the delivery device with any laser system other than an IRIDEX laser Such use may void product warranties and threaten the s...

Page 6: ... 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 Limitation of Liability contained in IRIDEX s Terms and Conditions Should you require assistance please contact your local IRIDEX Technical Suppo...

Page 7: ...88046 EN Rev A Introduction 4 ...

Page 8: ...ulb If there is a problem contact your local IRIDEX Technical Support representative Appearance and type of components may vary based on the delivery device ordered One pair of zero diopter lenses is included with the IRIDEX LIO Plus If desired you may interchange these lenses with the two diopter lenses that are factory mounted in the binocular eye pieces Headband height adjustment knob Optical u...

Page 9: ...X Lasers Adjusting for Pupillary Distance OcuLight Laser Family Illumination cable Fiber optic cable Slide to adjust Headband height adjustment knob Color filter selector Illumination field size adjustment IQ Laser Family Fiber optic cable Illumination cable ...

Page 10: ...ient 1 Turn on the laser 2 Reset the counter 3 Set the treatment parameters 4 Position the patient 5 Select an appropriate ophthalmoscopic examination lens 6 Select Treat mode 7 Position the aiming beam on the treatment site 8 Focus or adjust the delivery device as applicable 9 Press the footswitch to deliver the treatment beam To Conclude patient treatment 1 Select Standby mode 2 Record the numbe...

Page 11: ...closed position If there is still no treatment beam contact your local IRIDEX Technical Support representative No illumination light Verify that the illumination connector is connected to the console Verify that the special function control is not between detents Check the bulb and replace it if necessary Illumination light is too dim Verify that the special function control is not between detents...

Page 12: ...e fiber optic connector for cleanliness prior to use if needed clean the connector using a cotton swab moistened with acetone Inspect the fiber optic connector using a minimum of 100X magnification to verify cleanliness Inspect the lanyard for contamination before re installing it onto the fiber optic connector Cleaning the External Surfaces Wipe the external surfaces of the LIO except the optics ...

Page 13: ...sonnel Contact IRIDEX or your distributor for service information Changing the Illumination Lamp 1 Unscrew the retaining cap 2 Remove the burned out illumination lamp 3 Insert an identical replacement lamp aligning the key on the lamp base with the slot in the LIO Plus so that it points to the observer s right 4 Screw on the retaining cap ...

Page 14: ...uipment 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 installed into each vie...

Page 15: ...dicator 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 The IRIDEX LIO Plus is classified as a Group 1 instrumen...

Page 16: ...ev A Labels IRIDEX Corporation 1212 Terra Bella Ave Mountain View CA 94043 USA www iridex com Tel 650 940 4700 01 00813125 015619 11 20 0409 21 1234 567 30903 H500 Rev F LASER APERTURE OUVERTURE LASER Product Labels CE Labels Laser Aperture Label ...

Page 17: ...EX laser console for additional symbols Caution CE Mark Authorized Representative in the European Community Serial Number Manufacturer Part Number Waste Electrical and Electronic Equipment WEEE CSA Group Mark Health Canada Laser Aperture Illumination Field Size Selector Filter Selector ELT Mark LASER APERTURE OUVERTURE LASER ...

Page 18: ... 3 2 and above OcuLight GLx version 3 3 and above OcuLight SLx version 4 1 and above Laser spot size on retina with 20D lens 360 µm 1400 μm LIO Plus models 532 nm and 810 nm 532 nm 810 nm 577 nm 810 nm May vary with refractive power Operational and Storage Environmental Conditions Operational Environment Temperature Limits 10 C 50 F to 35 C 95 F Humidity Limits 20 80 Relative Humidity Non condensi...

Page 19: ...y result in increased emissions or decreased immunity of the laser system EMC Requirements for Console and Accessories Guidance and Manufacturer s Declaration Electromagnetic Emissions This laser system console and accessories is intended for use in the electromagnetic environment specified below The customer or the user of the laser system should assure that it is used in such an environment Emis...

Page 20: ...1000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 cycles 5...

Page 21: ...ter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 SQRT P 80 MHz to 800 MHz d 1 2 SQRT P 800 MHz to 2 5 GHz d 2 3 SQRT P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applica...

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