Second Sight Argus 2s Manuel utilisateur
Argus®2s
Retinal Prosthesis System
User Manual
095004-001 A
Rx Only: Federal law restricts this device to sale by or
on the order of a physician.
HUMANITARIAN DEVICE: Authorized by Federal
(U.S.) law to provide electrical stimulation of the retina
to induce visual perception in blind patients with severe
to profound retinitis pigmentosa and bare light or no
light perception in both eyes. The effectiveness of this
device for this use has not been demonstrated
Argus®2s
Retinal Prosthesis System
User Manual
Second Sight Medical Products, Inc.
13170 Telfair Ave
Sylmar, CA 91342, USA
Phone: +1 818 833 5060
Fax: +1 818 833 5067
E-mail: [email protected]
Visit us at www.secondsight.com
Copyright © 2021
Second Sight Medical Products, Inc.
Argus, Second Sight and the Second Sight Logo
are registered trademarks of
Second Sight Medical Products, Inc.
Table of Contents
Chapter 1: Glossary...........................................1
Chapter 2: Descriptive Information...................6
Indications for Use.............................................6
Device Description ............................................7
When the Device Should Not be Used
(Contraindications)..........................................27
General Warnings and Precautions.................28
Your Patient Identification Card.......................40
Risks and Probable Benefits...........................44
Chapter 3: What to Expect Before, During and
After Surgery ....................................................54
Before Surgery................................................54
The Day of Surgery.........................................54
After Surgery...................................................56
Chapter 4:Using Your Device..........................62
Setup Instructions............................................62
Operating Instructions.....................................67
Checking the Function of the Device...............72
Cleaning..........................................................73
Maintenance.................................................... 73
Handling and Storage......................................74
Expected Failure Time and Its Effect on You ..76
How to Safely Dispose of the Device ..............76
Chapter 5: Troubleshooting ............................80
Chapter 6: Additional information ..................88
Clinical Studies................................................88
Information about Retinitis Pigmentosa...........98
Warranty..........................................................100
Chapter 7: Contact Information.....................105
Chapter 8: Symbols and Regulatory
Classifications................................................107
Symbols ........................................................107
Regulatory Classifications.............................109
Appendix A: Potential Effects of
Electromagnetic Interference (EMI)..............113
Index................................................................ 118
Chapter 1: Glossary Page 1
Chapter
1:
Glossary
Term
Definition
Choroid
A thin layer of cells
between the retina and
the sclera that contains
pigments and blood
vessels. The blood
vessels bring oxygen
and nutrients to the
retina.(See Figure 1)
Conjunctiva
A thin layer of tissue that
covers the white part of
the eye and the inner
surface of the eyelids.
(See Figure 1)
Cornea
The clear layer of tissue,
shaped like a dome,
which lies on top of the
iris and the pupil. The
cornea is the eye’s outer
lens. It gives the eye its
major focusing ability.
(See Figure 1)
Chapter 1: Glossary Page 2
Term
Definition
Cyst
A closed sack of
abnormal tissue that may
contain air, fluids, or
semi-solid material.
Diagnosis
The identification of
disease by its symptoms.
Electrode Array
A grid of electrodes used
to stimulate the retina.
Electrical
Stimulation
A technique that uses
electrical currents to
activate nerve fibers.
Electromagnetic
Interference
(EMI)
A field of energy
(electrical, magnetic, or
both) created by
electronic equipment.
This field of energy may
be strong enough to
disrupt the normal
operation of your Argus
2s System.
Electrostatic
Discharge
(ESD)
A brief unwanted flow of
electrical current that can
cause damage to
electronic equipment.
Chapter 1: Glossary Page 3
Term
Definition
Incision
The surgical cut created
in your eye so that the
Argus II Implant can be
placed in your eye.
Iris
The iris is the round
structure in the eye that
gives the eye color. For
example, blue-eyed
people have a blue iris
while brown-eyed people
have a brown iris. The
center of the iris is an
opening called the pupil.
The iris controls the size
of the pupil when it
reacts to the amount of
light that is present.
(See Figure 1)
Radio
Frequency (RF)
Any electromagnetic
frequency within the
range used for wireless
communication.
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