Second Sight Argus II Manuale utente
900028-001 Rev D
Argus®II
Retinal Prosthesis System
Patient Manual
090000-002
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®II
Retinal Prosthesis System
Patient Manual
Second Sight Medical Products, Inc.
12744 San Fernando Rd., Building 3
Sylmar, CA 91342, USA
Phone: +1 818 833 5000
Fax: +1 818 833 5067
E-mail: service@2-sight.com
Visit us at www.2-sight.com
Copyright © 2013
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...................7
Indications for Use.............................................7
Device Description.............................................8
When the Device Should Not be Used
(Contraindications)...........................................28
General Warnings and Precautions.................29
Your Patient Identification Card.......................44
Risks and Probable Benefits............................47
Chapter 3: What to Expect Before, During and
After Surgery.....................................................59
Before Surgery ................................................59
The Day of Surgery..........................................59
After Surgery ...................................................61
Chapter 4: Using Your Device .........................68
Setup Instructions............................................68
Operating Instructions......................................72
Checking the Function of the Device...............79
Cleaning ..........................................................80
Maintenance....................................................81
Handling and Storage......................................81
Expected Failure Time and Mode and Its Effect
on You.............................................................84
How to Safely Dispose of the Device...............85
Chapter 5: Troubleshooting.............................89
Chapter 6: Additional information.................103
Clinical Studies..............................................103
Information about Retinitis Pigmentosa.........113
Warranty........................................................114
Chapter 7: User Assistance Information......118
Chapter 8: Symbols and Regulatory
Classifications................................................120
Symbols ........................................................120
Regulatory Classifications.............................122
Index................................................................ 126
Appendix A: Potential Effects of
Electromagnetic Interference (EMI).............. 132
Appendix B: Electromagnetic Environments
.........................................................................138
Chapter 1: Glossary Page 1
Chapter 1: Glossary
Term
Definition
Choroid{XE
"choroid" }
A thin layer of cells
between the retina and
the sclera that contains
pigments and blood
vessels that bring
oxygen and nutrients to
the retina
(See Figure 1)
Communication
Adapter (CA)
A device that is
connected to the Video
Processing Unit (VPU)
when the VPU is hooked
up to a computer in the
clinic
Conjunctiva{
XE
"conjunctiva" }
A thin layer of tissue that
covers the white part of
the eye and the inner
surface of the eyelids
(See Figure 1)
Chapter 1: Glossary Page 2
Term Definition
Cornea{XE
"cornea" }
The clear layer of tissue,
shaped like a dome, that
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)
Cyst
A closed sack of
abnormal tissue which
may contain air, fluids, or
semi-solid material
Diagnosis
The identification of
disease by its symptoms
and signs
Electrode Array
A rectangular grid of
electrodes used to
stimulate the retina
Electrical
Stimulation
A technique that uses
electrical currents to
activate nerve fibers
Chapter 1: Glossary Page 3
Term Definition
Electromagnetic
Interference{
XE
"electromagneti
c interference
(EMI)" }(EMI)
A field of energy
(electrical, magnetic, or
both) created by
electronic equipment.
This field of energy may
be strong enough to
interfere with the normal
operation of your Argus II
System.
Electrostatic
Discharge
(ESD{XE
"electrostatic
discharge
(ESD)" })
A momentary unwanted
flow of electrical current
that can cause damage
to electronic equipment
Incision The surgical cut created
in your eye by the doctor
so that the Argus II
Implant can be placed in
your eye
Chapter 1: Glossary Page 4
Term Definition
Iris{XE "iris" }
The iris is the round
structure in the eye that
gives someone his or her
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{XE
"Radio
Frequency
(RF)" }(RF)
Any electromagnetic
frequency within the
range used for wireless
communication
Retina{XE
"retina" }
A thin layer of nerve cells
at the back of the eyeball
which converts light into
nerve impulses that
travel to the brain
(See Figure 1)
Indice
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