Iridex LIO Plus Bedienungsanleitung

IRIDEX®LIO Plus

Operator Manual

IRIDEX®LIO Plus Operator Manual

88046-EN Rev A 06.2020

IRIDEX, the IRIDEX logo, IRIS Medical, OcuLight, 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.

88046-EN Rev A iii

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

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

Contraindications..........................................................................................................1

Factors Aecting Spot Size...........................................................................................1

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

IRIDEX Corporation Contact Information ................................................................3

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

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

Connecting the Cables to IRIDEX Lasers...................................................................6

Adjusting for Pupillary Distance ................................................................................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 ............................................................................................................................13

Symbols ........................................................................................................................14

IRIDEX® LIO Plus Specications ..............................................................................15

EMC Safety Information ............................................................................................16

Contents

1IRIDEX®LIO Plus Operator Manual 88046-EN Rev A

Introduction

The IRIDEX LIO Plus Laser Indirect Ophthalmoscope when connected to an IRIDEX laser, adds

the therapeutic capability of transpupillary retinal photocoagulation to the wide angle diagnostic

capabilities of a binocular indirect ophthalmoscope. It enables delivery of laser energy to the far

periphery of the retina and to treat supine patients. Integrated eye safety lters protect user’s eyes

while providing a clear view of the target area. Fully enclosed optics prevent misalignment and

contamination.

The LIO Plus is sold to medical doctors and intended to be used by trained medical professionals.

Indications for Use

The LIO Plus is indicated for transpupillary retinal photocoagulation.

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 on the retina is smallest in a myopic eye and

largest in a hyperopic eye.

A x (B/C) = spot size on the retina where:

• A = aerial spot size

• B = diopter power of handheld aspheric lens

• C = power of eye

Using this formula*:

• Emmetropic eye (60D):1100 μm x (20D/60D) = 360 μm spot size on retina

• Myopic eye (70D):1100 μm x (20D/70D) = 315 μm spot size on retina

• Hyperopic eye (50D):1100 μm x (20D/50D) = 440 μm spot size on retina

*Example only, power may vary by patient.

Positioning the 20D aspheric lens 55 mm from an emmetropic eye should produce a magnied aerial

image of the fundus.

88046-EN Rev A Introduction 2

Warnings and Cautions

WARNINGS:

Lasers generate a highly concentrated beam of light that may cause injury if improperly used.

To protect the patient and the operating personnel, the entire laser and the appropriate delivery system

operator manuals should be carefully read and comprehended before operation.

Carefully select your treatment room and location. Treatment locations should be free of uncovered

windows and reective surfaces that could inadvertently reect the treatment beam.

Never look directly into the aiming or treatment beam apertures or the ber-optic cables 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 reective surfaces.

Avoid directing the treatment beam at highly reective surfaces such as metal instruments.

Ensure that all personnel in the treatment room are wearing the appropriate laser safety eyewear.

Never substitute prescription eyewear for laser safety eyewear.

Always inspect the ber-optic cable before connecting it to the laser to ensure that it has not been

damaged. A damaged ber-optic cable could cause accidental laser 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 safety of the patient, yourself, and others in the treatment room.

CAUTIONS:

US federal law restricts this device to sale by or on the order of a healthcare practitioner licensed by the

law of the 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 specied herein may result

in hazardous radiation exposure.

Do not operate the equipment in the presence of ammables or explosives, such as volatile anesthetics,

alcohol, and surgical preparation solutions.

Turn o the laser before inspecting any delivery device components.

Always handle the ber-optic cables with extreme care. Do not coil the cable into a diameter less than

15 cm (6 in).

Do not use the cable retainers on the headset for ber-optic cables.

Keep the protective cap over the ber-optic connector when the delivery device is not in use.

Do not touch the bulb. Remove any ngerprints from the bulb with a cotton-tipped swab moistened

with methanol.

3IRIDEX®LIO Plus Operator Manual 88046-EN Rev A

IRIDEX Corporation Contact Information

IRIDEX Corporation

1212 Terra Bella Avenue

Mountain View, California 94043-1824 U.S.A.

Telephone: (650) 940-4700

(800) 388-4747 (U.S.A. only)

Fax: (650) 962-0486

Technical Support: (650) 962-8100

[email protected]

Website: iridex.com/lio

Emergo Europe

Prinsessegracht 20

2514 AP The Hague

The Netherlands

Warranty and Service. This device carries a standard factory warranty. This warranty is void if

service is attempted by anyone other than certied 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.

WEEE Guidance.

Dispose of equipment and accessories in compliance with local and regional regulations. Contact

IRIDEX or your distributor for disposal information.

88046-EN Rev A Introduction 4

5IRIDEX®LIO Plus Operator Manual 88046-EN Rev A

Operation

About the Components

Verify that you have received all of the components in the IRIDEX®LIO Plus package, and check the

components carefully before use to ensure that no damage occurred during transit. Along with this

manual, you should have the IRIDEX® LIO Plus, zero-diopter lenses, and a spare halogen bulb. 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 unit

adjustment Aiming beam

adjustment

Illumination and aiming

beam adjustment

Laser aperture

Fiber-optic cable

Illumination cable

Zero-diopter

lenses

Halogen

Bulb

88046-EN Rev A Operation 6

Connecting the

Cables to IRIDEX Lasers

Adjusting for Pupillary

Distance

OcuLight Laser

Family

Illumination cable

Fiber-optic cable

Slide to adjust

Headband height

adjustment knob

Color lter

selector

Illumination eld

size adjustment

IQ Laser Family

Fiber-optic cable

Illumination cable

7IRIDEX®LIO Plus Operator Manual 88046-EN Rev A

Instructions to Treat a Patient

Before treating apatient:

• Inspect the LIO before use to conrm it is in good operating order. Verify aiming beam is present,

uniform, round and not distorted prior to treatment.

• Ensure that the laser components and delivery device(s) are properly connected.

• Post the laser warning sign outside the treatment room door.

• Ensure that all ancillary personnel in the treatment room are wearing the appropriate laser

safety eyewear.

NOTE: Refer to Chapter 6, “Safety and Compliance,” and your delivery device manual(s) for important

information about laser safety eyewear and eye safety lters.

totreat apatient:

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.

toConClude patient treatment:

1. Select Standby mode.

2. Record the number of exposures and any other treatment parameters.

3. Turn o 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. Inspect and clean the LIO as instructed in section 4 Maintenance, below.

8. If an examination lens was used, handle the lens according to the manufacturer’s instructions.

9. Keep the protective cap over the ber-optic connector when the delivery device is not in use.

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