Iridex PASCAL LIO User manual

IRIDEX LIO Operator Manual Page 1 of 35
88294-EN, Rev B
PASCAL® Laser Indirect
Ophthalmoscope (LIO)
(532 nm or 577 nm)
(Single-Spot Version)
Operator Manual
European Authorized Representative Iridex Corporation
Obelis 1212 Terra Bella Avenue
Boulevard Général Wahis 53 Mountain View, CA 94043
1030 Brussels USA
Belgium Office: +1. 650.940.4700
Phone: [phone] Fax: [phone]
Fax: [phone] www.iridexretina.com
www.obelis.net

IRIDEX PASCAL LIO Page 2 of 35
88294-EN, Rev B
This manual is copyrighted with all rights reserved. Under the copyright laws, this manual
may not be copied in whole or in part or reproduced in any other media without the
express written permission of Iridex Corporation. Permitted copies must carry the same
proprietary and copyright notices as were affixed to the original under the law. Copying
includes translation into another language.
Please note that while every effort has been made to ensure that the data given in this
document is accurate, the information, figures, illustrations, tables, specifications and
schematics contained herein are subject to change without notice.
Iridex Corporation®, the Iridex Corporation Logo™, PASCAL®, and PASCAL Synthesis™
are trademarks or registered trademarks of Iridex Corporation.

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Table of Contents
Table of Contents .................................................................................................................. 3
Introduction ........................................................................................................................... 4
Setting Up and Using the LIO ............................................................................................... 5
Adjusting the Headband ........................................................................................... 6
Adjusting the Interpupillary Distance ........................................................................ 7
Obtaining a Fused Image ......................................................................................... 7
Adjusting the Mirror Angle ........................................................................................ 7
Turning on the Illumination ....................................................................................... 7
Setting the Aperture ................................................................................................. 8
Selecting the Filter ................................................................................................... 9
Adjusting the Illumination ....................................................................................... 10
Adjusting the Laser Angle ...................................................................................... 10
Adapting the Power Supply .................................................................................... 11
Laser Treatment .................................................................................................................. 12
Examining the Fundus ........................................................................................... 12
Battery Charger ................................................................................................................... 13
Inserting/Replacing the Battery Pack ..................................................................... 13
Charging the Battery Pack ..................................................................................... 14
Mounting the Wireless Charger .............................................................................. 16
Replacing the LED .............................................................................................................. 17
Cleaning .............................................................................................................................. 17
Specifications ...................................................................................................................... 18
Product Labels .................................................................................................................... 18
Service ................................................................................................................................ 19
General Safety and Regulatory Information ........................................................................ 20
Device Classification ........................................................................................................... 20
Intended Use ....................................................................................................................... 20
Warnings and Cautions ....................................................................................................... 20
Safety Considerations ......................................................................................................... 23
Symbols .............................................................................................................................. 24
Electromagnetic Compatibility ............................................................................................. 25
Warranty Information ........................................................................................................... 33
Warranty Shipments, Returns, and Adjustments ................................................... 33
Decontamination of Returned Equipment ........................................................................... 34
US Technical Service Information ....................................................................................... 34
WEEE Disposal ................................................................................................................... 34
Decontamination Certification ............................................................................................. 35

IRIDEX PASCAL LIO Page 4 of 35
88294-EN, Rev B
Introduction
Please read and follow these instructions carefully.
Iridex Corporation accepts full responsibility for safety, reliability and performance of the
device only if:
• Service, readjustments, modifications and/or repairs are performed exclusively by
Iridex Corporation-certified personnel.
• The electrical installation of the treatment room complies with the applicable IEC,
CEC and NEC requirements.
The warranty is void if any of these warnings are disregarded.
Iridex Corporation reserves the right to make changes to the device(s) herein. Device(s),
therefore, may not agree in detail with the published design or specifications. All
specifications are subject to change without notice. Please contact Iridex Corporation or
your local Iridex Corporation representative for information on changes and new products.

IRIDEX PASCAL LIO Page 5 of 35
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Setting Up and Using the LIO
The Iridex Corporation LIO is designed to connect to the PASCAL laser system. An optical
system projects an aiming and treatment laser beam delivered from the laser via a fiber
optic cable. The user can adjust the angle of projection of the laser by approximately ± 3º.
The illumination patch is separately adjustable.

IRIDEX PASCAL LIO Page 6 of 35
88294-EN, Rev B
Connecting the LIO to the laser
1. Turn on the laser console, as described in the Pascal operator manual.
2. Remove the dust caps from the laser optical fiber connector and the optical
fiber port on the front of the laser console.
3. Line up the pin in the fiber connector with the slot in the fiber port on PASCAL
or Streamline.
4. Screw on the fiber connector collar until it stops. Do not over tighten the collar.
NOTE: Reinstall the dust caps after use.
Adjusting the Headband
Ophthalmoscope Angle Alignment
For vertical alignment of the eyepieces and binocular block, adjust the height of the metal
outer brow bar, if necessary, by using the brow band tension knobs located on the sides
of the headset (fig 3).
Position the binocular block as close to the eyes or spectacles as possible for maximum
field of view. Slightly loosen the ophthalmoscope angle knob to allow for adjustment and
tighten when in position (fig 4).

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Adjusting the Interpupillary Distance
Because the eyes are dissociated, particular care must be taken to ensure the optics
(eyepieces) are set properly in front of each eye.
Always set the aperture selection to the large light patch for this exercise.
Place an object (e.g., your thumb) approximately 40 cm from the face, and center it
horizontally in the light patch. Then, close one eye. Using the thumb and forefinger of the
opposite hand, slide the interpupillary distance control of the open eye (located directly
under each eyepiece) so that your object moves into the center of the field, keeping the
object in the center of the light patch. Repeat for the other eye.
Obtaining a Fused Image
Ensure that a singular fused image is obtained, as follows:
Adjusting the Mirror Angle
The light is positioned vertically into the upper two thirds of the field of view by rotating the
mirror angle spindle located on either side of the binocular block.
Turning on the Illumination
Turn on the illumination by rotating the headband dimmer switch in a counter-clockwise
direction.

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Setting the Aperture
Rotate the aperture lever on the right side of the unit to select the aperture. The
illumination and viewing mirrors automatically adjust for maximum stereopsis.
Large
The large, round, homogeneous patch is suitable for routine examinations through fully
dilated pupils. The mirror remains in the forward position and the optics are diverged.
Intermediate
The intermediate patch is designed to reduce reflections when entering a partially or
poorly dilated pupil (3mm). It is also ideal for closer inspection of particular fundal areas.
The mirror and optics stay in the mid position.
Small
The small patch is ideal for small, undilated pupils. The mirror moves back and the optics
automatically converge.
Aperture Lever

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Selecting the Filter
Rotate the filter lever on the right side of the unit to select the filter.
Ensure filter is seated in proper position to prevent occlusion of vision.
Cobalt Blue
Used for fluorescein angioscopy
Clear (No Filter)
Ideal for inspecting a specific pathology, when brighter, whiter light is desired
Red-free
Reduces red light, so blood appears black, silhouetted against a dark background
Diffuser
Produces an extra wide beam of diffused light, which permits a more relaxed
technique during challenging fundus examinations
NOTE
Beginners may find the diffuser filter helpful, because the alignment between the
headset, the condensing lens, and the pupil, in order to achieve a full lens image, is
not as critical as with a conventional beam.
Filter Lever

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Adjusting the Illumination
Rotate the illumination adjustment control on the front of the unit to adjust the illumination
patch. The illumination control has a larger adjustment range than the laser control, so it is
best to adjust the laser first then overlay the illumination.
Adjusting the Laser Angle
Rotate the laser angle control on the front of the unit to adjust the angle of projection of
the laser up or down by 3 degrees either side of the optical axis.
Illumination Angle Adjustment
Adjustment Control
Laser Angle Control

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Adapting the Power Supply
Replace the blanking plate with the appropriate mains plug adapter, if required, or use IEC
60320 Type 7 connector (not supplied).
IEC 60320 Type 7
Connector

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Laser Treatment
Examining the Fundus
1. Prepare the patient (e.g., dilate the pupils).
2. Set the illumination to a low intensity. Always start with a low intensity to protect the
patient’s eyes and increase lamp life.
3. Hold the aspheric lens in front of the patient’s eye so that the engraving on the lens
mount faces you. Let your little finger rest on the patient’s head to support your hand.
The distance between you and the patient should be about 40 cm.
4. Center the illumination beam in the patient’s pupil. Bring the fundus image into focus
by moving your head forward or backward and changing the position of the aspheric
lens.
Before performing laser treatment you should be thoroughly familiar with the operation of
the laser indirect ophthalmoscope as a diagnostic instrument and with the PASCAL laser
system.
Perform the following procedure in conjunction with the instructions in the Pascal operator
manual.
1. Prepare the patient for treatment.
Use care when treating thru cataracts, opaque vitreous fluid or when
performing treatment with reduced or compromised viewing of target
tissue
2. Select the desired treatment parameters, as described in the Pascal operator manual.
3. Make any necessary adjustments to the headset to ensure safe and clear view of the
retina.
4. Select READY mode to turn on the aiming beam.
5. Position the aspheric lens, and observe the fundus of the patient’s eye through the
LIO. The aiming beam should be visible as a red spot in the center of the field of view.
The aiming beam should appear as a round and uniform spot located in the center of
the field of view. Do not continue with treatment if the aim beam spot is not round or if
it appears distorted or clipped and does not have uniform brightness.
Never fire the laser if the aiming beam is not clearly visible on the
target tissue
6. Move your head forward and backward until you obtain the smallest spot size. You
may fail to achieve the desired physiological effect if the laser spot is not properly
focused. If you are using the 20 D aspheric lens, the diameter of the spot will be 360
µm (for an emmetropic patient eye).
7. Depress the footswitch to deliver the treatment laser beam to the tissue.

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Battery Charger
Inserting/Replacing the Battery Pack
1. Press the release button to release the battery pack.
2. Lift the battery pack from the cradle.
3. Place the new battery pack in the cradle until fully engaged.
Battery Pack
on Headset
1
2
3
1
2
3
Battery Pack
on Charger

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Charging the Battery Pack
1. Replace the blanking plate on the power supply with the appropriate mains plug
adapter.
2. Connect the power supply cable to the power input socket on the charger.
3. Plug the power supply into the mains outlet.
4. Place the spare battery pack or headset into the charger.
Mains Plug Adapter
Blanking Plate
Power Supply Cable
Power supply inlet
Spare battery pack
Charger
Headset

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Indicator Lights
On headband battery holder:
• flashing LED—battery requires charging
On charger:
• no indicator—battery fully charged
• flashing indicator—top up charge
• solid indicator—rapid charge
The battery pack can be used at any time during the charging cycle and will automatically
resume charging when placed back in the charger. The lights on the charger indicates
which battery is being charged.
Charging Cycle
The battery on the headband takes 2 hours to fully charge and will last approximately 2
hours on full power. The spare battery takes 4 hours to charge.
Charging Spare Battery
Charging Battery
on Headband

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Mounting the Wireless Charger
Use the template document provided to mark the position of the charger and drill holes.

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Replacing the LED
The LED may get hot during prolonged use. Allow it to cool before replacing.
1. Remove the LED from the back of the unit.
2. Insert the new LED, ensuring the alignment key is properly oriented and the LED is
pushed all the way into the unit.
Cleaning
Use only manual, non-immersion cleaning as described. Do not autoclave or immerse in
cleaning fluids.
1. Disconnect the power supply from the source.
2. Wipe the external surfaces with a clean, absorbent, non-shedding cloth dampened
with a water/detergent solution (2% detergent by volume) or water/isopropyl alcohol
solution (70% IPA by volume). Avoid optical surfaces.
Ensure the cloth is not saturated with solution and excess solution does not enter the
instrument.
3. Carefully hand-dry all surfaces using a clean, non-shedding cloth.
4. Safely dispose of used cleaning materials.
LED

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Specifications
[Specifications are subject to change without notice]
Product Labels
Manufacturer
CE Mark
Laser Emission Warning
Nominal laser spot size on the fundus using
a 20 D lens
360 µm (aiming and treatment beams)
Laser optical fiber
Length
Core diameter
5 m
100 µm
Physician’s safety filter
Transmission < 0.005% for 577 nm or 532
nm per LIO model

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System Wavelength
Compatibility
When LIO is calibrated to
a specific laser system.
Service
There are no user serviceable parts. Please refer all service requests to your local Iridex
Corporation representative.

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General Safety and Regulatory Information
Iridex Corporation products are precision medical instruments that have undergone
extensive testing. With proper handling, they are useful and reliable clinical instruments.
To protect operating personnel and patients, this entire manual and the PASCAL laser
system operator manual should be read thoroughly before operation.
Iridex Corporation does not recommend specific clinical practices. The following
precautions are extensive but may not be complete.
Device Classification
CE Regulation 93/42 EEC: Class IIb
FDA: Class II
Intended Use
The LIO is intended for use by medical professionals trained in the use of ophthalmic laser
equipment and procedures.
US Federal law restricts this device to sale by or on the order of a healthcare practitioner
licensed by law of the State in which he/she practices to use or order use of the device for
its indicated uses.
The LIO is intended for use in photocoagulating ocular tissue in the treatment of diseases
of the eye.
Warnings and Cautions
The Laser Indirect Ophthalmoscope (LIO) is intended for the treatment of ocular pathology
and is indicated for use in retinal photocoagulation procedures. The LIO is indicated for
use for the particular indications of the PASCAL® laser system to which it is attached.
This device is designed for safe use with a laser of specific wavelength. Check the
markings on the top of the LIO (near the optical fiber connection), and ensure they match
those on the connected laser.
The LIO contains safety filters to reduce reflected laser light to safe levels for users.
Always look through the ophthalmoscope when the treatment beam is activated. Do not
look over the ophthalmoscope when the treatment beam is activated.
Test prior to use.
To minimize risk of patient movement during operation, ensure patient has been
adequately prepared.