Second Sight Medical A01 Argus II Retinal Prosthesis System User Manual Before You Get Started

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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.
900028-001 Rev D
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
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 1
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 2
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 3
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)
Chapter 1: Glossary
Page 4
Term
Definition
Sclera{ XE
"sclera" }
The white outer coating
of the eye made of tough
tissue which allows the
eye to keep its shape
and helps to protect the
delicate inner parts of the
eye (See Figure 1)
Therapy
Treatment of disease or
disorders
VPU{ XE "VPU"
} (Video
Processing
Unit)
The part of the Argus II
System that processes
the information that is
sent to and from the
implant inside your eye
Chapter 1: Glossary
Page 5
Figure 1: Parts of the Human Eye
Conjunctiva
Sclera
Choroid
Image courtesy of the National Eye Institute,
National Institutes of Health
Chapter 1: Glossary
Page 6
Chapter 2: Descriptive Information
Indications for Use{ XE "indications for
use" }
The Argus II Retinal Prosthesis System is
intended to provide electrical stimulation of the
retina to induce visual perception in blind patients.
You are eligible for the Argus II system if you have
severe to profound retinitis pigmentosa and you
meet the following criteria:
•
You must be an adult, age 25 years or
older.
•
You must have bare light or no light
perception in both eyes. If you do not have
any remaining light perception, your doctor
will test your eye to make sure it will
respond to electrical stimulation.
•
You need to have been able to see objects,
shapes and lines in the past.
•
In the eye that will be implanted, you either
need to have an artificial lens or no lens at
all. (If the eye that will be implanted still
has a natural lens, your doctor will remove
this lens during the implant surgery.)
•
You must be willing and able to follow the
recommended schedule of clinical follow-
Chapter 2: Descriptive Information
Page 7
up, device programming and visual
rehabilitation after you are implanted.
Your doctor will implant the Argus II Implant in only
one of your eyes, most likely the eye that has the
worse vision. Your doctor will discuss with you
which eye is best for the implant before your
implant surgery.
Device Description
The Argus II Retinal Prosthesis System consists of
the following main parts and accessories:
•
•
•
•
Argus II Retinal Prosthesis (Implant)
Argus II Video Processing Unit (VPU)
Argus II Glasses (Glasses)
Accessories:
• VPU Rechargeable Battery
• VPU Battery Charger
• VPU Pouch
• Travel Case
WARNING
Do not use any equipment with
your Argus II System other than
that supplied by Second Sight.
Chapter 2: Descriptive Information
Page 8
If you use cables or batteries not supplied by
Second Sight, your Argus II system may be
more likely to experience interference from
other electronic devices. The use of nonapproved cables or batteries may also cause
the Argus II System to interfere with other
electronic equipment.
Refer to the Appendices A and B for more
information about interference with other electronic
equipment.
How Does the Argus II System Work?
You will have the Argus II Retinal Prosthesis
implanted in and around your eyeball. To turn on
and use the implant, you need to wear the glasses
and VPU.
When you are using the system, a miniature video
camera on the glasses captures images in real
time. The glasses send these images to the VPU.
The VPU converts these video images into
electrical signals and send them back to the
glasses. The coil on the glasses sends the signals
wirelessly to the implant. The implant then sends
out small pulses of electricity to the retina in your
eye. These pulses stimulate your retina. Your
retina sends the nerve signals along the optic
nerve to your brain. You perceive these pulses as
patterns of light. Over time, you may learn how to
Chapter 2: Descriptive Information
Page 9
interpret these visual patterns as objects and
shapes.
Note: The implant is on only when you are wearing
the glasses and have the VPU turned on.
Otherwise, the implant is off.
The sections below describe each of the parts of
the Argus II System.
Argus II Retinal Prosthesis (Implant)
The implant consists of four parts: (1) the
electronics case (2) the implant coil, (3) the
electrode array, and (4) the scleral band.
Figure 2 shows the implant as it looks after it has
been implanted. Part of the implant sits on the
outside of your eye and part goes inside your eye.
The implant is not visible to other people.
The electronics case, the implant coil and the
scleral band sit on the outside of the eye. The
scleral band wraps around your eye and holds the
implant in place. A thin layer of tissue that covers
the white part of the eye also covers the parts of
the implant that sit on the outside of the eye.
A cable connects the electronics package to the
electrode array. This cable enters your eye
through an incision made during surgery. At the
end of cable is the electrode array. The electrode
Chapter 2: Descriptive Information
Page 10
array is attached to the surface of your retina with
a retinal tack.
The electrode array provides electrical stimulation
to your retina. It has 60 electrodes arranged in a
rectangular grid. Fifty-five of these electrodes are
turned on at the time of implant. Up to 5 of the
remaining electrodes may be functional and could
be turned on to replace an electrode that is not
working.
Patient Contacting Materials of the Implant and
Tack
The implant and retinal tack are made of following
materials:
•
•
•
•
•
Niobium
Platinum
Polyimide (plastic)
Silicone Rubber
Titanium
Chapter 2: Descriptive Information
Page 11
Figure 2: Implant on a Right Eye
(looking at your eyeball)
Electronics Case
(outside the eye)
Scleral Band
(outside the eye)
Implant Coil
(outside the eye)
Electrode Array
(inside the eye)
Chapter 2: Descriptive Information
Page 12
External Equipment
Figure 3 shows the VPU, glasses, and battery{ XE
"external equipment" }.
Figure 3: External Equipment
VPU
Glasses
Glasses Coil
Camera
Video Processing Unit (VPU){ XE "VPU" }
The VPU allows you to turn stimulation on and off.
Using the buttons on the VPU, you can change the
stimulation program to suit your current
environment. The VPU buttons are large and have
distinct shapes so that you can easily identify them
by touch.
The VPU connects to the glasses using a cable.
The cable from the glasses plugs into the glasses
receptacle on the VPU to connect these two parts.
You must wear both the VPU and glasses for the
system to work.
Chapter 2: Descriptive Information
Page 13
The VPU keeps track of when you turn it on and
off, and it keeps a record of how well your implant
and VPU are functioning. The VPU also records
when there is break in the wireless link between
the implant and glasses. Your clinician can check
all of this information when you visit the clinic.
There is a “communication adaptor connector” on
the bottom of the VPU. Your clinician will use this
connector in the clinic to connect the VPU to a
computer. A metal door covers this connector. The
VPU with the battery weighs about half a pound
(0.23 kilograms). See Figure 4 for a diagram of the
VPU.
Chapter 2: Descriptive Information
Page 14
Figure 4: VPU{ XE "VPU" }
Top of
VPU
Indicator lights
Glasses
Receptacle
Power
Button
Inverse
Setting
Button
Program
Setting 1
Program
Setting 2
Audible RF
Link Alarm
Button
Program
Setting 3
Right Side
of VPU
Battery in
Receptacle
Left
Side
of VPU
Battery
Latch
Bottom
of VPU
Chapter 2: Descriptive Information
Communication
Adapter
Connector
(Only used
in the clinic)
Page 15
Table 1 describes the parts of the VPU. Table 2
describes the accessories that you use with the
VPU.
Table 1: VPU{ XE "VPU" } Components
Component
Description
Case
The case is the outside of the
VPU.
Power
Button
The power button is a roundshaped button located on the
right side of the VPU. You use
this button to turn the VPU on
and off.
Program
Setting
Buttons
The Program Setting buttons{
XE "VPU:program setting
buttons" } are the three ovalshaped buttons located on the
front of the VPU. You press
these buttons to select a
stimulation program. The button
with a single circle is Program
Setting 1. The button with two
circles is Program Setting 2.
The button with a small bar is
Program Setting 3.
The VPU starts in Program
Setting 1each time you turn it
on.
Chapter 2: Descriptive Information
Page 16
Component
Description
Inverse
Setting
Button
The inverse button is the
square-shaped button located
on the right-hand side of the
VPU. You use this button to
invert{ XE "VPU:invers setting
button" } the image from blackto-white and white-to-black.
Each time you press it, the VPU
inverts the image. The VPU
starts in “non-invert” mode each
time you turn it on.
Link Alarm
Button{ XE
"VPU:RF
link alarm" }
The link alarm button is the starshaped button located on the
bottom of the right side of the
VPU. You use this button to
turn the audible link alarm on
and off. This alarm sounds if the
VPU loses communication with
the implant. Each time you turn
the VPU on, the VPU starts up
with the link alarm on.
Battery
Receptacle
The battery receptacle holds the
battery in place on the VPU. It is
located on the front panel below
the program setting buttons.
Chapter 2: Descriptive Information
Page 17
Component
Description
Battery
Latch
The battery latch is located on
the left side of the VPU. The
latch holds the battery in place.
To remove the battery, you
must first slide the latch to its
“un-locked” position.
Indicators
Lights
Three indicator lights are
located on the front of the VPU
between the program setting
buttons. These give a visual
indication of the status of the
VPU. For example, the orange
light will come on if the glasses
cable is not properly connected
to the VPU. Refer to Table 7 on
page 76 for a description of
each of these lights.
Glasses
Receptacle
The glasses receptacle is a
round connector on the top of
the VPU. You attach the
glasses to the VPU by plugging
them in to this receptacle.
Chapter 2: Descriptive Information
Page 18
Component
Communication
Adapter
(CA)
Connector
Description
The Communication Adapter
Connector is rectangular
connector located on the bottom
of the VPU. A metal door
covers this connector. To
program the VPU, your clinician
connects a computer to your
VPU using this connector.
Table 2: VPU Accessories
Accessory
Description
Battery{ XE
"battery" }
Rechargeable batteries power
the VPU. You can choose to
use either small or medium
sized rechargeable batteries.
Only use rechargeable
batteries provided to you by
Second Sight.
Battery
Charger
Recharge the batteries using
the battery charger provided
with the Argus II System.
VPU Pouch
The pouch allows you to wear
the VPU rather than carrying it.
With the pouch, you can wear
the VPU on your belt or over
your shoulder.
Chapter 2: Descriptive Information
Page 19
Glasses
The glasses{ XE "glasses" } have a miniature video
camera in the bridge above the nose. The glasses
also have a coil on one of the earpieces. The coil
sends power to the implant and communicates
wirelessly with it. The glasses connect to the VPU
with a cable. See Figure 5. Table 3 provides a
description of the parts of the glasses and the
storage case for the Argus II System components.
Figure 5: Glasses for the Right Eye
Cable
Camera
Glasses Coil
Patient Contacting Materials of the Glasses
The glasses{ XE "glasses:materials" } are mostly
made of plastic and include the following
materials:
•
•
Acrylonitrile Butadiene Styrene (ABS)
Aluminum
Chapter 2: Descriptive Information
Page 20
•
•
•
•
•
Carbon fiber
Nylon
Polycarbonate
Polyvinyl chloride (PVC)
Thermoplastic Elastomeric
Table 3: Glasses Components and
Accessories
Component
Description
Glasses
The glasses{ XE "glasses" } are a
pair of sunglasses that have a
miniature video camera and coil
attached to them.
Camera
A miniature video camera{ XE
"camera" } is located in the center
of the glasses frame directly above
the nose bridge. The camera
sends video images to the VPU.
Glasses Coil
The glasses coil contains the
receiver and transmitter antennae.
The coil is located on the arm of
the glasses on the side where the
implant is located. The Argus II
system uses the coil to
communicate wirelessly with the
implant.
Chapter 2: Descriptive Information
Page 21
Component
Description
Cable
The cable connects the glasses to
the VPU. The cable is part of the
glasses. Do not attempt to
remove the cable from the
glasses.
Travel
Case{ XE
"travel case"
Use the travel case to safely store
and transport the VPU, glasses
and batteries. See Figure 6.
Figure 6: Travel Case
Glasses
VPU
Chapter 2: Descriptive Information
Page 22
Argus II System Wireless Information
The Argus II Glasses use wireless technology{ XE
"wireless technology" } to power the implant and to
send and receive information from the implant.
Table 4 below summarizes information about the
wireless technology used in the Argus II System.
Table 4: Wireless Technology Specifications
Frequency
(to the implant)
3.156 Megahertz (MHz)
Frequency
(from the implant)
473 – 490 Kilohertz (KHz)
Bandwidth
(to the implant)
13 Kilohertz (KHz)
Bandwidth
(from the implant)
20 Kilohertz (KHz)
Power
(to the implant)
Amplitude modulation (AM)
Less than 1.2 watts
Power
(from the implant)
Frequency shift keying (FSK)
Less than 10 microwatts
Wireless Link
Performance
The system maintains
wireless link more than 90%
of the time when the coil is
approximately 1 inch
(2.5 cm) or closer to the
implant.
Chapter 2: Descriptive Information
Page 23
How to Achieve Wireless Link with the Glasses
Wear the glasses as you would a typical pair of
glasses. Your clinician positions the glasses coil to
ensure that it has good wireless link with the
implant. The glasses and the implant automatically
connect and operate when the glasses are placed
on your head and the VPU is turned on. Refer to
“Wearing the Glasses” on page 71 for more
details.
Wireless Security
The Argus II implant only operates if it is within a
very short distance from the coil on the glasses.
The Argus II System uses coded signals to make it
harder for outside sources to accidentally or
intentionally control the System. The Argus II
System does not store or send any information,
such as your name, that would allow you to be
identified.
Quality of Service
In order for your Argus II System to work, the
Glasses and VPU cannot lose the communication
link with the implant. The glasses and VPU
communicate with the implant through a wireless
link. For the wireless link to work, the glasses coil
must be close to the implant. To make sure the
system works properly, wear your glasses in the
same position as they were when you were fitted
Chapter 2: Descriptive Information
Page 24
in the clinic. When the wireless link between the
glasses and implant is broken, an alarm will sound
and will continue to sound until the wireless link is
restored. You may lose the link in the presence of
strong magnetic or radio fields. Refer to the
section entitled “Possible Interference with Other
Electronic Devices” on page 39 and Appendices A
and B for more information on interference related
to the wireless system.
For Troubleshooting regarding link loss, see page
97.
Chapter 2: Descriptive Information
Page 25
Argus II Patient Catalog
The following items are included in your Argus II
Retinal Prosthesis Patient Catalog{ XE "catalog
numbers" }:
Table 5: Patient Catalog
Description
Argus II Video Processing
Unit{ XE "VPU" }
including Patient Manual
VPU Batteries:
VPU Battery{ XE "VPU
battery" } (small)
VPU Battery (medium)
Argus II Glasses{ XE "glasses"
}:
Glasses, Right Eye, Dark
Lenses
Glasses, Right Eye, Clear
Lenses
Glasses, Left Eye, Dark Lenses
Glasses, Left Eye, Clear Lenses
VPU Battery Charger{ XE
"battery charger" }
Chapter 2: Descriptive Information
Catalog /
Product
Number
013003
100200-001
100200-002
012011
012012
012013
012014
100200-004
Page 26
Description
Catalog /
Product
Number
Argus II Travel Case{ XE
"travel case" }
012930
Argus II VPU Pouch{ XE "VPU
pouch" }
013931
Chapter 2: Descriptive Information
Page 27
When the Device Should Not be Used
(Contraindications)
You should not have the Argus II Retinal
Prosthesis{ XE "contraindications" } implanted if
you:
•
Have an eye disease or condition that could
prevent the Argus II System from working
properly. { XE "strabismus" }
•
Have an eye structure or condition that
could make it difficult to successfully
implant the Argus II Implant or recover
following surgery. For example, if you have
a very long or very short eye, you may not
be eligible for the Argus II Implant.
•
Have eye diseases or conditions that make
it difficult for your doctor to see inside your
eye. For example, if you have a cloudy
cornea, you may not be eligible for the
Argus II Implant.
•
Are unable to undergo general anesthesia{
XE "anesthesia" }{ XE "general anesthesia" }
•
Are unable to take the recommended
antibiotic{ XE "antibiotic" } and steroid{ XE
"steroid" } medications that you need to take
before and after implant surgery.
•
Have a metallic or active implantable device
in your head. For example, if you have a
Chapter 2: Descriptive Information
Page 28
cochlear implant, you are not eligible for an
Argus II Implant.
•
Have any disease or condition that prevents
you from understanding or giving your
informed consent. For example, if you have
difficulty remembering things, you may not
be eligible for an Argus II Implant. Your
doctor may ask you to have a psychological
evaluation to make sure you are qualified
for this device.
•
Have any disease or condition that prevents
you from having medical follow-up or
having the VPU programmed.
•
Tend to rub your eye a lot.
General Warnings and Precautions
Warnings
Once you have an Argus II Implant:
•
Do not undergo short wave or microwave
diathermy{ XE "diathermy" }. These
procedures could cause high electrical
current in the implant electrodes that could
cause tissue damage or serious injury.
Diathermy may also cause permanent
damage to the implant.
•
Do not undergo
electroconvulsive
therapy (ECT){ XE "electroconvulsive
Chapter 2: Descriptive Information
Page 29
therapy (ECT)" }. ECT may damage your
eye or your Argus II Implant.
•
Avoid lithotripsy{ XE "lithotripsy" } or high
output ultrasound{ XE "ultrasound" }.
These procedures may harm you or
damage the implant. If you need one of
these procedures, inform your doctor that
you have this implant. Your doctor should
contact Second Sight Medical Products for
instructions on how to perform these
procedures in someone who has an Argus
II Implant.
•
Do not enter a room housing a magnetic
resonance imaging (MRI){ XE "magnetic
resonance imaging (MRI)" } System that
has a rating other than 1.5 or 3.0 Tesla,
even if you are not using Argus II System.
The only part of the Argus II System that
has been tested for use with MRI is the
implant. The Argus II Implant is classified
as an MR Conditional{ XE "magnetic
resonance imaging (MRI):MR conditional" }
device.
If you have an Argus II Implant, you may
undergo an MRI procedure ONLY if it is
performed using a 1.5 or 3.0 Tesla MRI
System and ONLY following special
instructions. Before having an MRI
procedure, tell your doctor that you have
Chapter 2: Descriptive Information
Page 30
the Argus II Implant. Your doctor should
contact Second Sight Medical Products for
these instructions on how to perform an
MRI in someone who has an Argus II
Implant.
If you feel any pain{ XE "pain" } during the
MRI procedure, tell the technician
immediately.
Do not take the VPU or glasses into the
MR system room. The VPU and glasses
are MR Unsafe. Severe harm to people in
the MR system room or damage to this
equipment may result.
•
Do not use the Argus II System within 3
feet (0.9 meters) of medical monitoring,
diagnostic or life support equipment.
Using the Argus II system near this
equipment may cause the equipment to
function improperly. If someone notices that
interference is occurring, turn off the
Argus II VPU or extend the distance
between yourself and the equipment.
•
Do not receive treatment with monopolar
XE
electrosurgical
equipment{
"electrosurgical equipment" }. Monopolar
electrosurgical equipment may damage the
implant or the tissue around the implant.
General Precautions
Chapter 2: Descriptive Information
Page 31
•
Stop using the Argus II System if you
experience any uncomfortable feeling such
as pain{ XE "pain" }. Should this occur,
immediately take off the Argus II Glasses or
turn off the Argus II VPU. Then contact your
doctor or programming clinician to report
the problem.
•
Contact your doctor promptly if you feel any
pain or watering in your implanted eye or if
you have the feeling that something is in
your implanted eye. This may be a sign
that you have a complication on the outside
or inside of your eye. If your doctor does
not examine your eye when you have these
symptoms, you may develop an infection in
your eye or have other serious
complications.
•
The long-term effects of electrical
stimulation are unknown. It may cause
damage to the retina or optic nerve. This
sort of damage could lead to a decline in
your normal remaining vision and/or how
well you see with the Argus II System. It
could also prevent you from getting a
replacement Argus II Implant or another
type of retinal implant or treatment in the
future.
•
Do not use anyone else’s VPU. Only use
the VPU that your clinician programmed for
you. Using someone else’s VPU may limit
Chapter 2: Descriptive Information
Page 32
how well you see with the Argus II System.
It could also cause you pain{ XE "pain" } if it
provides stimulation that is too strong.
•
Avoid physical impact or extreme direct
pressure to the eye. This could cause injury
to your eye, movement of the implant in
your eye, or damage to the implant.. If this
occurs, contact your physician.
•
Avoid rubbing your implanted eye. This
may dislodge the implant or cause eye
irritation.
•
Do not rely on the Argus II System as your
only aid when walking. The Argus II System
will not provide you with enough vision to
walk safely without any other aids. Even
though you have the Argus II Implant,
continue to use your other mobility aids (for
example, canes, dogs) at all times.
•
Do not use the Argus II System during
pregnancy or when nursing a baby. Second
Sight has not evaluated the use of the
Argus II System by women who are
pregnant or who are nursing a child{ XE
"pregnancy and nursing" }.
Electromagnetic
Interference
(EMI){
"electromagnetic interference (EMI)" }
XE
Electromagnetic interference is a field of energy
(electrical, magnetic, or both) created by
Chapter 2: Descriptive Information
Page 33
equipment found in public environments that may
be strong enough to interfere with the normal
operation of your Argus II System.
The Argus II System meets international standards
for electromagnetic compatibility (See Chapter 8
and Appendix B for more information). The Argus
II System continues to operate in a “safe mode” in
the presence of any electromagnetic interference
that you would encounter during your normal
everyday activity.
It is important to note, however, that in certain
circumstances, electromagnetic interference could
cause:
• Serious injury. Exposure of your implant to
EMI may result in your implant heating and
damaging nearby retinal tissue. See
“Warnings” on page 29.
• Damage to your Argus II Implant. Damage
to the implant may require replacement; or
result in loss of, or irreversible change in
the performance of the Argus II System.
See “Warnings” on page 29.
• Unexpected shutdown of the Argus II VPU.
EMI may cause your VPU to turn off
unexpectedly.
• Interruption of Stimulation. EMI may cause
a momentary interruption of stimulation.
Chapter 2: Descriptive Information
Page 34
If you suspect that electronic equipment is causing
interference with your Argus II System, you should
do the following:
1. Move away from the equipment or object
thought to be causing the interference.
2. If possible, turn off the equipment or object
causing the interference.
3. Tell the equipment operator or your doctor
what happened.
If you continue to experience interference, or if you
think that your Argus II System is not working as
well as it did before you encountered the
interference, please contact your doctor.
The following sections provide additional
information regarding potential sources of
electromagnetic interference:
•
Precautions Regarding Other Medical
Procedures
•
Possible Interference
Electronic Devices
from
•
Air Travel, General
International Use
Travel
Other
and
The potential effects of EMI from devices or
procedures are summarized in Appendix A.
Chapter 2: Descriptive Information
Page 35
Additional information about electromagnetic
compatibility is included in Appendix B.
Chapter 2: Descriptive Information
Page 36
Precautions
Procedures
Regarding
Other
Medical
General Information (applicable to all procedures)
•
If you need to undergo any of the
procedures listed below, please inform your
doctor that you have a retinal prosthesis in
your eye. Your doctor should contact
Second Sight at 1-818-833-5060 for more
information.
•
Do not wear or use your Argus II
Glasses or VPU when undergoing a
medical test or procedure, unless you
are having a vision test. Using or wearing
the Argus II Glasses or VPU during these
procedures could cause you harm. It might
also make it difficult for your doctor to
understand the results of the test. Finally, it
could damage the Argus II equipment.
•
Once the procedure is complete, you
should have your clinician test your Argus II
Implant as soon as possible to make sure it
is still functioning properly. Damage to the
implant may not be immediately detectable.
Information about Specific Procedures
•
Magnetic Resonance Imaging (MRI){ XE
resonance imaging (MRI)" } –
"magnetic
Chapter 2: Descriptive Information
Page 37
Refer to section “Warnings” on page 29 for
information about MRI.
•
Avoid the use of laser{ XE "laser" },
fragmatome{ XE "fragmatome" } or
phacoemulsification{
XE
"phacoemulsification" } in your implanted
eye. These procedures may damage the
Argus II Implant.
•
Avoid the use of bipolar electrosurgical
equipment{ XE "electrosurgical equipment"
} in your implanted eye. This equipment
may damage the Argus II Implant.
•
You may undergo computed tomography
scan{ XE "computed tomography scan (CT
scan)" } (CT Scans) or Diagnostic
Ultrasound. However, if you need a scan
or ultrasound{ XE "ultrasound" } in the area
where the Argus II Implant is located, the
implant may block or blur the image making
the scan unreadable in this area.
•
Use of defibrillator{ XE "defibrillator" }s or
radiation therapy{ XE "therapeutic ionizing
radiation" } to the head may permanently
damage the Argus II Implant. However, this
should not stop you from receiving these
treatments if necessary.
•
The effects of cobalt treatment{ XE "cobalt
treatment" } or linear acceleration{ XE
Chapter 2: Descriptive Information
Page 38
"linear
acceleration" } techniques on the
implant are unknown.
Possible Interference from Other Electronic
Devices
•
Avoid Theft{ XE "detector:theft" } or metal{
XE "detector:metal" } detectors (such as
those located in entrances to public
buildings and department stores) and
airport{ XE "airport" } or security
screening{ XE "security screening" }
devices. If unavoidable, turn off your VPU,
walk through the scanner, and quickly move
away from the area. Do not lean on these
scanners or linger in their path. These
devices may temporarily interrupt Argus II
stimulation if you are using the Argus II
System within 1 yard (0.9 meters) of them.
Your Argus II System will start operating
normally when you move away from these
items. You should show your patient
identification card to any attendant in the
area who may be able to assist you in
bypassing these devices.
•
Avoid Electronic Article Surveillance{ XE
"electronic
article:surveillance" } (EAS)
systems, EAS Tag Deactivators{ XE
"electronic
article:deactivator"
},
and
Radiofrequency identification (RFID){ XE
"radiofrequency identification (RFID)" }
Chapter 2: Descriptive Information
Page 39
systems. These systems may temporarily
interrupt Argus II stimulation if you are
using your Argus II System within 3.5 yards
(3.2 meters) of them. Your Argus II System
will start operating normally when you move
away from these items. RFID systems, EAS
systems and tag deactivators send out
energy fields that wirelessly communicate
with tags attached to objects such as
merchandise,
materials
and people.
Business uses these systems for security,
theft prevention, tracking and inventory
control. Retail stores, libraries, government
buildings, warehouses and offices often use
these systems. For example, security tags
attached to clothing contain RFID tags.
•
Avoid handling the VPU and glasses if you
suspect there may be static electricity{ XE
"static electricity" } present. Static electricity
may interfere with normal operation or
cause damage to the Argus II System. For
example, walking across carpet in a low
humidity environment can cause you to
build up static electricity.
•
The Argus II System may interfere with the
normal operation of some models of
hearing aids{ XE "hearing aids" }. If you
wear a hearing aid, you should have it
tested with the Argus II System before
implant surgery to make sure both the
Chapter 2: Descriptive Information
Page 40
hearing aid and Argus II System will
function properly.
•
Avoid home appliances, such as
microwaves,{ XE "microwaves" } and some
devices with antennae, such as cell
phones, when using the Argus II System.
Home appliances and devices with
antennae may temporarily interrupt Argus II
stimulation. The table below lists the
distance at which interruption of stimulation
may occur with these systems.
Table 6: Separation Distances
Type of device
Another Argus II
System
Cell phone
Cordless phone
Bluetooth{ XE
"bluetooth" } device
Microwave oven
WiFi{ XE "WiFi" }
Access Point
Wireless Router{ XE
"wireless router" }
Distance from the
Argus II System
7 inches (17.5 cm)
1 inch (2.5 cm)
1 inch (2.5 cm)
1 inch (2.5 cm)
1 inch (2.5 cm)
8 inches (20 cm)
8 inches (20 cm)
Devices with antennae may be marked with
the following symbol:
Chapter 2: Descriptive Information
Page 41
Normal operation will resume when you
move away from these items.
•
Do not turn on the Argus II System on an
airplane{ XE "airplane" }. The Argus II
System operates using wireless technology
that could interfere with the safe operation
of an airplane.
•
Avoid commercial electrical equipment,
communication equipment, high voltage
lines, power lines or generators,{ XE "power
generators" } electric steel furnaces, or
large magnetized speakers. These types of
equipment may temporarily interrupt Argus
II System function. Normal operation should
resume when you move away from these
objects.
Examples
of
commercial
electrical
equipment include arc welders, induction
furnaces and resistance welders. Examples
of communication equipment include
microwave transmitters, linear power
amplifiers
and
high-power
amateur
transmitters.
Air Travel, General Travel and International
Use
CAUTION: Do not turn on the VPU or use the
Argus II System on an airplane{ XE "airplane" }.
The Argus II System operates using wireless
Chapter 2: Descriptive Information
Page 42
technologies that could interfere with the safe
operation of an airplane.
You may want to travel with your Argus II System.
When travelling and not using the Argus II System,
store the Glasses and VPU in the travel case.
If you will be traveling outside the United States,
you may need an adapter to plug the VPU battery
charger into the electrical outlet.
Bring your patient identification card with you to
assist in going through security systems. The
section below describes the patient identification
card. Turn off the VPU when you go through
security.
If your eye is experiencing any medical
complications before your trip, speak with your
doctor to determine if it is safe for you to travel,
especially on a plane. You may also wish to speak
with your doctor in advance of your trip to obtain
the name of a local ophthalmologist in the event of
any complications during your trip.
For more information about travel, contact the
Transportation Security Administration (TSA):{ XE
"Transportation Security Administration (TSA)" }
Website: www.tsa.gov
Email:
TSA-ContactCenter@dhs.gov
TSA General Phone Number: 866-289-9673
Chapter 2: Descriptive Information
Page 43
TSA Cares Phone Number:
855-787-2227
TSA Cares is a toll free helpline designed to assist
travelers with disabilities and medical conditions,
prior to getting to the airport{ XE "airport" }. You
should call TSA Cares 72 ahead of traveling so
that the TSA has the opportunity to coordinate
checkpoint support with a TSA Customer Service
Manager located at the airport when necessary.
Your Patient Identification Card
You will receive a patient identification (ID){ XE
"patient identification (ID) card" } card after your
implant surgery. This card provides basic
information about your implant and lists your
doctor’s name and telephone number. The
information is important for others to know in case
you need to bypass a security system or in the
event of a medical emergency. Keep this card with
you at all times. To assist you in locating the card
in your wallet, the plastic covering for the card has
two clipped corners on one side that you will be
able to feel. Refer to Figure 7 below for an
example of a patient ID card. This figure does not
show the plastic covering with the clipped edges.
Chapter 2: Descriptive Information
Page 44
Figure 7: Patient ID Card
Chapter 2: Descriptive Information
Page 45
If you change your address or doctor’s
information, contact Second Sight to obtain a new
card. Include the current information and indicate
the changes. You may either call 1-818-833-5060
with the information or send it to the following
address:
Second Sight Medical Products, Inc.
Device Registration
12744 San Fernando Rd., Bldg. 3
Sylmar, CA 91342, USA
In addition to your Patient Identification Card, you
may want to wear a Medical Alert Bracelet{ XE
"medical alert bracelet" }. If you choose to
purchase one of these bracelets, you should
include the following information on it:
Active Implantable Device on (right or left) Eye
See Patient ID Card in my wallet
Doctor’s Phone is (XXX) XXX-XXXX
Chapter 2: Descriptive Information
Page 46
Risks and Probable Benefits
Risks
There are risks{ XE "risk" } to having surgery and
risks of having the Argus II Implant. Listed below
are many of the problems you might come across
having and using the Argus II System. Some of
the risks listed happened to patients in the clinical
trial{ XE "clinical trial" }, some did not. Some
patients experienced more than one event. Some
events are minor, some more severe. Certain
events are more likely to occur than others are.
For information about the risks experienced by
patients in the clinical trial, please refer to Chapter
6.
Surgical Risks
To receive the Argus II System, you will need to
have surgery{ XE "risk:surgery" }. During this
surgery, your doctor will implant the Argus II
Implant in and around the eye. You will need to
have general anesthesia. Any surgery where you
are under general anesthesia carries some risk.
The following are rare but possible general risks of
surgery:
•
Blood clots in the legs or lungs (pulmonary
embolism or deep vein thrombosis)
•
Blood loss requiring transfusion
Chapter 2: Descriptive Information
Page 47
•
Difficulty to urinate
•
Chest pain{ XE "pain" }, heart attack, or
respiratory failure
•
Allergic reaction to the anesthetic
After the surgery, your eye will need to heal. You
may have side effects from the medicine you need
to take after the surgery.
Risks of the Argus II System
Once you have the implant, there are risks
associated with having an implant in your eye.
There are also the risks{ XE "risk:Argus II specific" } of
having electricity stimulate the nerve cells in your
eye.
The following are risks specific to the Argus II
Implant:
•
The implant or the sutures{ XE "suture" }
holding the implant in place on your eye
could wear through the layer of tissue that
covers the eye. If the implant or the sutures
wear through this tissue, you may feel pain{
XE "pain" } or discomfort. This type of event
can also lead to an infection in your eye.
Sometimes surgery is required to re-cover
the exposed parts to protect the other
tissues of your eye and prevent more pain
or infection. If surgery cannot resolve the
Chapter 2: Descriptive Information
Page 48
problem, your doctor may need to remove
the implant from your eye.
•
One or more of the wound{ XE "wound" }s
from the surgery could open. This can
cause discomfort and can lead to an
infection in the eye. If surgery cannot repair
the opening in the tissue, your doctor may
need to remove the implant from your eye.
•
Infection{ XE "infection" } in the eye is
serious.
You would need to get any
infection treated quickly. Normally, your
doctor would inject medicine into your eye
to treat the infection. If this does not work,
your doctor may need to remove the
implant from your eye. In rare cases, if you
have an infection that cannot be resolved
you may need to have your eye removed.
•
Your eye pressure may get too high or too
low. Normally, your doctor would give you
medication to treat this. Your doctor may
also need to inject air or oil into your eye. In
more severe cases, you may need surgery
to return your eye pressure to normal. In
rare cases, if the eye pressure gets
extremely low, you may need to have your
eye removed.
•
Separation of the layers of the eye, or a
tear in the retina{ XE "tear in the retina" }
(the innermost layer) may need surgery or
Chapter 2: Descriptive Information
Page 49
treatment with a laser{ XE "laser" } to fix. In
some cases, these events may affect how
well the Argus II System works.
•
Large-scale growth of cells{ XE "growth of
cells" } in the eye that pull on the retina or
growth of strands of tissue that pull on the
inner lining of the eye may lead to
separation of the layers of the eye. If this
happens to you, you may need surgery to
repair this problem.
•
The implant could move or the retinal tack{
XE "retinal tack" } holding the implant could
become loose. You may need surgery to
adjust the position of the implant in your
eye or to re-tack it to your retina.
•
The implant could stop working due to
mechanical or electrical problems. Surgery,
physical impact to the eye, or exposure to
harmful levels of energy could also damage
the implant. If the implant stops working,
you may need surgery to remove the
device.
•
You may need to have surgery to move the
implant to a new position to improve how
well it functions.
•
The implant could cause electric shock{ XE
"electric shock" }. A skin burn{ XE "skin burn"
} could also occur due to too much heating
of the glasses or VPU. Contact your doctor
Chapter 2: Descriptive Information
Page 50
or programming clinician right away if you
experience these events. There may be a
malfunction in your Argus II System.
•
Some pain{ XE "pain" } in or around the eye
may occur right after surgery. This pain
usually goes away in a few days or weeks.
If you have any pain in the eye or
headaches after you have recovered from
the eye surgery, report it to your doctor.
Note that this pain may occur while you are
using the Argus II System or when the
system is off. Usually, your clinician can
adjust the program on your VPU to
eliminate any discomfort that occurs when
the system is on.
•
After implantation surgery, you may notice
some decrease{ XE "decrease in light
perception" } in how much light you can
see. If this happens, you should tell your
doctor. While this problem may go away on
its own, it is possible that this change could
be permanent.
•
An eyelash{ XE "eyelash" } caught under the
conjunctiva{ XE "conjunctiva" } can cause
discomfort. Your doctor will use a pair of
tweezers to remove the eyelash if this
occurs.
•
Damage to or interference with the eye
muscles or eyelids, including drooping of
Chapter 2: Descriptive Information
Page 51
the eyelid{ XE "drooping of the eyelid" } may
occur. Often, this does not require any
treatment. In severe cases, you may need
surgery to repair the damage.
•
Implantation of this device may prevent you
from receiving future treatments{ XE "future
treatments" } for retinitis pigmentosa in the
implanted eye. Your other eye, however,
will be available for alternative treatments.
•
There is a possibility of damage to your
retina due to injury, too much stimulation{
XE "over-stimulation" }, or heating of the
implant.
•
The implant could affect how the nerves in
your face work. This could cause twitching
in your face or could affect how the muscles
in your face work. This could affect how
you do things such as smile or frown.
•
The implant could wear through the layers
of tissue beneath it. If part of the implant
moves into the eye, you might need surgery
to either repair the tissue or remove the
implant.
•
Your body may have an allergic reaction{
XE "allergic reaction" } to the materials in the
implant or glasses. The following materials
in the implant{ XE "materials in the implant" }
contact the tissues and fluids in your eye:
niobium, titanium, polyimide, silicone
Chapter 2: Descriptive Information
Page 52
rubber, and platinum. The materials in the
glasses{ XE "materials in the glasses" }
contact your skin. These materials include
the following: carbon fiber, polycarbonate,
plastic elastomeric, acrylonitrile butadiene
styrene (ABS), thermoplastic elastomeric,
aluminum, polyvinyl chloride (PVC) and
nylon. If the reaction is severe, you may
need to have the implant removed or stop
using the Argus II System.
•
The Argus II System could distract you from
noticing cues from your other aides. You
could fall or bump into something even
while using the system. Do not rely on the
Argus II System as your only aid when
walking.
The following events may occur occasionally
and typically resolve on their own or with
medication:
•
Infection{ XE "infection" } outside the eye
•
Redness and irritation in or around the eye
•
Irritation caused by the sutures
•
Separation of the choroid from the sclera
•
Bleeding{ XE "bleeding" } in the eye
•
Clouding, thinning, scraping, or folding of
the cornea{ XE "cornea" }
•
Blood vessels, deposits, rough
“threads” or mucus on the cornea
Chapter 2: Descriptive Information
spots,
Page 53
•
Dryness of the cornea
•
Dry eye{ XE "dry eye" } or watering eye{ XE
"watering eye" }
•
Cyst{ XE "cyst" }s on the eye
•
Nausea{ XE "nausea" } or dizziness{ XE
"dizziness" }
The following events may occur occasionally
and typically do not require any treatment:
•
Swelling of the retina or choroid
•
Splitting of the layers of the retina
•
Fold(s) in the retina
•
Growth of blood vessels on the iris
•
Formation of scar tissue in the eye
•
Fluid building up in the choroid
•
Feeling that something is in the eye
•
Movement of the tissue patch used to cover
the implant
•
Increase in eye movements that you cannot
control
Possible “Cascade{ XE "risk:possible \"cascade\"
of events" }” of Adverse Events
There is the risk that one event could lead to
another. One event could cause other events to
get worse. If this happens, it may take several
Chapter 2: Descriptive Information
Page 54
visits to your doctor, several treatments, and/or
surgery to treat. If the events do not resolve, you
may need to have the implant removed. In the
extreme case, your doctor may have to remove
your eye.
Probable Benefits and Limitations of the
Argus II System
The Argus II System{ XE "probable benefit" }{ XE
"limitations of the Argus II System" } provides a
form of vision that differs from the vision you used
to have. It does not restore normal vision. It does
not slow or reverse the progression of your
disease. In addition, it will not replace your normal
visual aids. You will have to learn how to use the
Argus II System with your other aides (such as a
dog or a cane) and techniques. When you are not
using the Argus II System, your vision will return to
its original impaired state.
When first using the system, you may not be able
to tell exactly what you are looking at. Learning to
understand the signals from the device and use it
in your everyday life may be a challenging
process. You will need training to learn how to
interpret the vision provided by the Argus II
System.
How Much Field of View Can the Argus II System
Give Me?
Chapter 2: Descriptive Information
Page 55
The Argus II System{ XE "field of view" } delivers
electrical signals to your retina that will allow you
to see spots of light. The implant is designed to
give you a visual field{ XE "visual field" } of about
3.5 inches by 6.5 inches (9 by 16.5 centimeters) at
arm's length, or slightly larger than a standard 3 x
5-inch index card. However, the actual size of light
you see when the system turns on all the
electrodes together may be larger or smaller.
Each implant has 60 electrodes. Not every
electrode in the array will be able to allow you to
see a spot of light on its own. For most subjects in
the clinical trial{ XE "clinical trial" } (28 out of 30)
the number of electrodes that could do this was
less than 60. If fewer than 20 of the 60 electrodes
produce spots of light on their own, your clinician
may change the program on the VPU to turn on
groups of electrodes at the same time. A “quad” is
when four electrodes next to each other on the
array stimulate at the same time.
It is possible that not all of your electrodes will be
used and, as a result, your visual field may be
reduced. In addition, the total number of
electrodes that provide spots of light can decrease
over time. A single electrode could stop working or
parts of your retina could stop responding to the
signal sent by that electrode.
Chapter 2: Descriptive Information
Page 56
What will the spots of light look like to me?
Electrodes in the Argus II System do not always
create circular spots of light. Sometimes the light
looks like a line or a wedge. During the clinical
trial{ XE "clinical trial" }, three subjects were asked
to draw what they saw when a single electrode
was activated. In these three subjects, the spots
of light ranged in length from 0.75 inches (1.9 cm)
(if they were being viewed from an arm’s length
away) to 18 inches (45.7 cm).
The first subject reported a non-circular shape in
20 of the 29 electrodes tested. The second subject
reported a non-circular shape in 24 of the 24
electrodes tested. The final subject reported a
non-circular shape in 16 of the 29 electrodes
tested.
In these three subjects, the size of the individual
light spots ranged from less than 1 square inch
(6.5 square centimeters) in size (if they were being
viewed from an arm’s length away) to 46 square
inches (297 square centimeters). Most of the
electrodes created spots of light that were less
than 5 square inches (32.3 square centimeters) in
size.
Chapter 2: Descriptive Information
Page 57
What Are the Probable Benefits of the Argus II
System?
The Argus II System{ XE "probable benefit" } may
help you do tasks visually, rather than by touch.
During the clinical trial{ XE "clinical trial" }, some
subjects were able to locate lights and windows,
follow lines in a crosswalk, or avoid running into
things as they walked. Some subjects could sort
laundry or determine where other people were
located in a room. About half of the subjects were
able to read very large letters (about 9 inches high
viewed from 1 foot away or about 23 centimeters
high viewed from 0.3 meters away). A few
subjects were able to read smaller letters (about 12 inches high viewed from 1 foot away or about
2.5-5 centimeters high viewed from 0.3 meters
away) and short words. In addition, many subjects
reported enjoying seeing light and motion after
being blind for many years and having a greater
feeling of connection to their environment and to
other people.
Results varied among clinical trial{ XE "clinical trial"
} subjects. While the majority of subjects received
a benefit from the Argus II System on multiple
tests and exams, some subjects reported
receiving no benefit.
Chapter 2: Descriptive Information
Page 58
Chapter 3: What to Expect Before,
During and After Surgery
Before Surgery
Two days before surgery{ XE "surgery" }, you will
start taking antibiotics.
The Day of Surgery
Below is general information about how the Argus
II System is implanted.
1. On the day of surgery, you will come to the
hospital. The surgical procedure will generally
last four hours, but it may be shorter or longer.
During the implant procedure, you will undergo
general anesthesia{ XE "anesthesia" }.
2. If you have a natural lens in your eye, your
doctor will remove it before inserting the
implant. If you have an intraocular lens in your
eye, your doctor will likely leave it in place.
3. Your doctor will pull back the conjunctiva (the
thin tissue that covers the white part of your
eye and the inside of your eyelid). If your eye
orbit is small, your doctor may need to make a
small cut at the outer corner of the eyelids to
make it easier to place the device.
Chapter 3: What to Expect
Page 59
4. Your doctor will then place the implant around
your eye. Your doctor will adjust the implant so
that it fits snugly against your eye. Your doctor
will secure the band on the implant around
your eye using a small silicone sleeve. Your
doctor will stich the implant to your eye to hold
it in place.
5. Your doctor will then make small hole in the
wall of your eye and will remove all of the gellike fluid inside your eye. Your doctor will
replace the fluid with a saline solution.
6. If you have a thin layer of tissue over your
retina, your doctor may remove this by gently
peeling it off the retina.
7. Your doctor will then attach the electrode array
of the implant to your retina with a small retinal
tack. Your doctor will test the implant to make
sure it is functioning properly.
8. If the device is functioning properly, your doctor
will close all of the cuts in your eye. Your
doctor will then place a thin layer of tissue
(from a human donor) over a small portion of
the implant on the outside of your eye.
9. Your doctor will close the conjunctiva with
stitches that will dissolve over time.
10. Your doctor will patch your eye and you will be
escorted to the recovery room.
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11. After you recover from surgery, you will leave
the hospital with instructions to take oral
medication and use eye drops to control
swelling, infection{ XE "infection" }, and pain{
XE "pain" }.
12. Your doctor may elect to admit you overnight to
the hospital for observation, or could discharge
you the same day as the surgery.
After Surgery
After you have the Argus II Implant, you will need
to return several times to the clinic for clinical
follow-up{ XE "clinical follow-up" }, device
programming{ XE "device programming" }, and
visual rehabilitation{ XE "visual rehabilitation" }.
You should consider living close enough to the
clinic or temporarily relocate closer to the clinic to
allow you to fully participate in the recommended
follow-up.
Recovering from Surgery
After your surgery and discharge from the hospital,
your doctor or nurse will provide you with
instructions on how to recover. These instructions
will include information about what medications
you will need to take and when you will need to
return for follow-up visits. Always follow these
instructions.
Chapter 3: What to Expect
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If you experience any medical complications with
your implant, it is important to follow the
instructions provided by your doctor for how to
treat these complications.
It may take several weeks for you to recover from
surgery. During this time, you may feel discomfort
around your eye. If you notice unusual symptoms,
contact your doctor.
Clinical Follow-Up{ XE "clinical follow-up" }
The day after surgery, your doctor will examine
your eye. You will return to the hospital one week
later to have your eye checked again. At this time,
if the doctor feels that you have recovered well
enough from your surgery, you will begin to have
your Argus II System custom programmed for you
(See Device Programming section below).
You will need to continue to return to the hospital
periodically so that your doctor can check the
health of your eye. These periodic visits will
continue as long as the Argus II Implant remains in
your eye. A typical follow up schedule might
include visits at 2 weeks, 1 month, 3 months, 6
months, and 12 months followed by annual or
semi-annual visits.
Device Programming{ XE "device programming"
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In order for you to see anything from the Argus II
System, it will need to be custom programmed, or
“fitted” for you. Someone other than your doctor
will likely perform this programming. This person,
a “programming clinician” could be another doctor,
nurse or technician.
Initial Programming Sessions
The purpose of the initial programming sessions is
simple: to find suitable stimulation levels so that
the first visual program can be set on your VPU.
To do this, you will need to come to the clinic
where your clinician will connect the VPU to a
special computer. The programming clinician will
provide electrical stimulation to one electrode at a
time. Your clinician will record your response to
the stimulation. Your clinician will use these
responses to create custom programs. Your
clinician will download these programs to your
VPU so you can use your Argus II System.
In case stimulating one electrode at a time is
determined to be insufficient, the clinician may
choose to stimulate groups of four electrodes next
to each other (called a “quad{ XE "quad(s)" }”) at
the same time. If the clinician chooses to use quad
stimulation, the clinical will divide the entire array
into 15 quads arranged in 3 rows of 5 columns.
For people who need quad stimulation, quad
electrode stimulation usually results in brighter
perception than single electrode stimulation. Also,
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a larger region of your array may become usable
with quad stimulation, resulting in a larger field of
view. These features may allow you to make
better use of the device even if single electrode
stimulation gives you little vision.
CAUTION: Please note that the effect of using
quad stimulation compared to single electrode
stimulation was not specifically studied during
the clinical trial{ XE "clinical trial" }.
Depending
on
your
results,
this
initial
programming may take one visit lasting one to two
hours, or it may take a few such visits.
Preparing for Using the Argus II System at Home
Once your clinician downloads the programs to
your VPU, your clinician will turn on the VPU. You
will then start to see spots of light. Your clinician
will then adjust the camera position to line it up
with how the implant is located inside your eye.
You clinician will show you how to connect the
glasses to the VPU, how to operate the controls
and switches on the VPU, and how to understand
the alarms and indicator lights. Your clinician will
train you how to perform simple troubleshooting
and how to care and maintain your Argus II
System.
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You will need to come to the clinician many times
in the 4-6 weeks after surgery to have your system
programmed and to receive training. Once you
complete these two activities, you will be able to
start using your Argus II System at home.
Typically, patients in the clinical trial{ XE "clinical
trial" } started home use of the System one to
three months after their implant surgery.
Follow-up Programming
After the initial programming sessions, you may
need to visit your programming clinician on a
regular basis for a tune up{ XE "follow-up
programming" }. The brightness of perception and
the number of electrodes that can give you
perception may decrease over time. If your
perceptual experience with the device changes,
you should contact your programming clinician for
a follow-up programming session.
Visual Rehabilitation{ XE "visual rehabilitation" }
It is important to learn how to use the device to fit
your specific needs. Second Sight has a
recommended visual rehabilitation program. This
rehabilitation program will allow you to improve
your use of the system. It should increase your
ability to perform daily activities and help reach
your goals for using the Argus II System. A typical
rehabilitation program may include five to ten one
hour sessions. These might take place at the
Chapter 3: What to Expect
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hospital, at another institution, in your home, at
your work, or some combination of these settings.
Your doctor can provide more details about your
rehabilitation program.
As part of this rehabilitation program, you may
receive some items to take home with you to help
you practice and learn more about the system. It is
important to spend time practicing in order to
maximize the benefit that you get from the system.
The Importance of Following a Care Regimen
The following guidelines about your Argus II
System will help to ensure that you receive the
safest and most beneficial treatment.
Always tell any medical personnel that you have
an implant in your eye and tell them where it is
located. If they have any questions, they should
contact your doctor or Second Sight at
1-818-833-5060.
If you experience any unusual symptoms that you
think are related to your Argus II Implant, contact
your doctor.
If you have a family member or caregiver, ask
them to read this manual along with you. There
may be situations where you will need their
assistance.
Chapter 3: What to Expect
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Go to all follow-up appointments. This will ensure
that you get the best care.
When to Call Your Doctor
Call your doctor if any of the following situations
occur:
•
You are experiencing any pain{ XE "pain" }
or discomfort in your implanted eye.
•
You feel any discomfort during stimulation.
First, turn off your Argus II System (by
shutting off the VPU or taking off your
glasses), then call your doctor.
•
You are having any difficulty operating your
Argus II System or any of the components
break.
•
You feel like the information/stimulation you
receive from your Argus II System is getting
worse.
•
You experience any unusual symptoms that
you think electromagnetic interference is
causing{ XE "detector:theft" }.
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Chapter 4: Using Your Device
Setup Instructions
To set up the equipment for use, follow the
instructions below.
1. Charge the battery{ XE "battery:charging" }.
Before using the battery for the first time,
charge it fully. To charge the battery, plug in
the battery charger and place the battery in
the receptacle of the charger. It takes
approximately three hours to fully-charge a
battery. A sighted individual can help you
check if the battery is fully charged. When the
battery is charging, the orange charge light is
on. When the battery is fully charged, the light
will be off.
2. Install the battery{ XE "battery:installation" }.
To install the rechargeable battery, slide the
VPU battery latch so that it opens (as shown
in Figure 8 below). While holding the latch
open, slide the battery in the receptacle away
from the latch until the battery latch
automatically slides into its locked position.
3. Remove the battery{ XE "battery:removal" }.
To remove the battery, slide the VPU battery
latch so that it opens (toward the top of the
VPU). Holding the latch open, slide the battery
Chapter 4: Using Your Device
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as far as you can toward the latch and lift it out
of the receptacle. Release the latch.
Figure 8: Battery Latch{ XE "battery:latch" }
Being Held Open
4. Confirm proper installation of the battery.
Confirm that you have installed the battery
correctly by gently pulling it. If the battery
comes loose, re-install it by performing Step 2
again.
CAUTION: Do not use any batteries with
the VPU other than those given to you
by Second Sight. Use of other batteries
may damage the VPU or cause it to
function improperly and void the
manufacturer’s warranty.
5. Wearing the VPU. If you would like to wear
the VPU, you will need the VPU pouch. Place
the VPU in the pouch and lock it in place using
the Velcro® strap near the right side of the
VPU next to the star-shaped button. Secure
the VPU in place with the other Velcro strap.
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Once the VPU is in the pouch, you can wear
the VPU.
6. Connecting
the
glasses{
XE
"glasses:connecting" } to the VPU{ XE
"VPU:connecting" }. The glasses are equipped
with a cable that you insert into the glasses
receptacle located on the top of the VPU. To
connect the glasses to the VPU, perform the
following steps:
(a) Always make sure the VPU is turned off
before connecting the glasses.
(b) Grasp the cable and hold it by the rubber
piece at the end. Notice that the rubber
piece makes an L-shape. This L-shape
aids in proper orientation of the plug.
(c) Locate
the
round-shaped
glasses
receptacle on the VPU.
(d) Insert the cable plug into the glasses
receptacle. Point the cable end of the plug
towards the right side of the VPU where
the circular power button is located. Apply
pressure to insert the plug into the glasses
receptacle. If the plug does not insert,
gently rotate it for proper alignment while
trying to insert it. Once aligned, insert the
plug into the glasses receptacle.
(e) Push the plug firmly into the receptacle
until you hear a click. Note that the plug
does not lock.
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7. Disconnecting
the
glasses{
XE
"glasses:disconnecting" } from the VPU{ XE
"VPU:disconnecting" }. Always turn the VPU
off before disconnecting the glasses. If you
need to disconnect the glasses from the VPU,
hold the VPU firmly in one hand. Using the
other hand, grasp the L-shaped plug at the
end of the glasses cable and gently pull it
straight away from the VPU.
CAUTION: Do not pull the glasses cable
out of the VPU at an angle as this may
damage the receptacle or the VPU.
8. Wearing the glasses{ XE "glasses:wearing
the glasses" }. Using both hands, gently put
on the glasses as you would a typical pair of
glasses. Adjust the cable so that it is
comfortable and does not catch on anything
such as your arms or clothes. You can thread
the cable inside your clothing to prevent it
from getting caught on objects while you
move.
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CAUTION: Do not adjust the position of
the glasses coil. The coil position is set
to
optimize
by
your
clinician
performance of the device. Changing the
coil position may cause loss and/or
interruption of stimulation. Contact your
clinician if your VPU audible alarm
beeps frequently.
CAUTION: Use care when putting on the
glasses. Do not over-extend the glasses
arms as this could break them.
CAUTION: Do not attempt to adjust the
camera mounted on the glasses as you
may damage the camera or glasses.
You could also alter the alignment of the
camera.
Operating Instructions
CAUTION: Do not exchange your VPU with
another patient’s VPU. If you use another
patient’s
VPU,
you
could
have
uncomfortable stimulation.
CAUTION: If you experience any discomfort
during the use of the device, please contact
your clinician or Second Sight promptly.
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To use the VPU and
instructions below.
glasses, follow the
1. Lighting Conditions. The Argus II System
uses the camera in the glasses to capture the
video image that it sends to your implant.
Since the camera does not work well in dimly
lit environments, make sure that you have
enough light in your surroundings when you
are using the System. If you are inside, you
should always make sure the lights are on in
the room. If possible, a sighted individual
should confirm that your lights are working
properly.
2. Turning on the VPU{ XE "VPU:turning on" }.
Put the glasses on as described above. To
turn on the VPU, press the circular power
button on the side of the VPU and hold it down
for approximately two seconds until you hear
four short beeps.
3. VPU Start-up tests. Immediately after the
VPU turns on, it performs a series of tests.
These tests last approximately 30 seconds.
During these 30 seconds, the green indicator
light will blink quickly. You may or may not see
something during these tests. Once these
tests are complete, stimulation will begin and
the green indicator light will blink more slowly
(1 blink per second) to indicate that the VPU is
operating properly.
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4. Possible clicking noise from the glasses
coil. You may hear a clicking noise from the
glasses. This is part of the normal operation
of the glasses and does not indicate a failure
of any kind.
5. Changing program settings. The VPU{ XE
"VPU:changing program settings" } has 3
program settings that you can select by
pressing one of the three oval-shaped buttons
on the front of your VPU. The button with a
single circle is Program Setting 1. The button
with two circles is Program Setting 2. The
button with a small is Program Setting 3. You
may change the program you are using to
adjust for different lighting or contrast
conditions. When you first turn the VPU on, it
defaults to Program Setting 1. Each time you
change the Program Setting, the VPU will
produce a short beep.
6. Inverting the image. To invert the image from
black-to-white and white-to-black, press the
square button located in the middle of the
right-hand side of the VPU{ XE "VPU:inverting
the image" }. Each time you press this button,
the image will invert and the VPU will beep.
7. Audible RF link alarm{ XE "VPU:audible RF
link alarm" }. To turn the RF link alarm on or
off, press the star-shaped button next to the
inverse button. The RF link alarm tells you
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when the communication link with the implant
has been temporarily lost.
8. Turning off the VPU{ XE "VPU:turning off" }.
To turn off the VPU, press the power button
and hold it down for approximately one
second. When the VPU is turning off, it will
sound one beep followed by a pause, followed
by two short beeps. Once the VPU is off, all
indicator lights on the VPU will be off.
Indicators and Audible Alarms
The VPU uses both visual and audible indicators
to provide you with information about the status of
the VPU and glasses and to tell you about
problems with the Argus II System. Table 5 and
Table 6 summarize the meaning of these
indicators. Figure 9 below shows the location of
the indicator lights on the VPU.
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Figure 9: VPU{ XE "VPU:indicator lights" }
Indicator Light Colors
Green
Amber
Orange
Table 7: Indicator Light Colors
Indicator
Light
Color
Green
Light
flashing
Fast
periodic
blinking
Meaning
The VPU is going
through its start-up
diagnostic testing.
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Indicator
Light
Color
Light
flashing
Meaning
Green
Slow
periodic
blinking
(1 per
second)
The VPU is operating
normally.
Orange
Solid
There is a problem
with the video signal.
(For example, the
glasses cable is not
properly connected to
the VPU).
Amber
Solid
There is a loss of
communication
between the implant
coil and glasses coil.
Amber
Blinking
There is intermittent
communication
between the implant
coil and the glasses
coil.
Table 8: Audible Alarms
Sound
Single short beep
Meaning
A button{ XE "VPU:audible
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Sound
Meaning
alarms" } has been pressed (for
example, a Program Setting or
Inverse Setting Button).
One beep followed by
a pause, followed by
two short beeps
The VPU is turning off.
Four short beeps
The VPU is starting up.
Three short beeps
An error has occurred and the
VPU is about to shut down
automatically.
Periodic beeping
pattern (3 short beeps
followed by 1 long
beep, followed by 3
short beeps, followed
by a long pause)
The battery level is low.
Slow periodic beep
(1 every 2 seconds)
There is a problem with the video
signal.
Fast periodic beep
(2 per second)
There is a loss of communication
between the implant coil and
glasses coil. This alarm can be
temporarily turned off by pressing
the star-shaped button on the
right side of the VPU (the Audible
RF Link Alarm Button).
Battery Life
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On average, the small battery will last 2.5 to 3.5
hours and the medium battery will last 4 to 6
hours. Actual battery life{ XE "battery:battery life" }
may vary. Once the battery runs out of charge
you will need to recharge it.
VPU settings as well as when and where you use
your device will all affect how long the battery
charge lasts. Battery capacity will also drop
gradually over time with use of the VPU. If your
battery charge is not lasting very long each time
you charge it, the battery has probably reached
the end of its life. Contact your clinician or Second
Sight for a replacement battery.
Recharging the Batteries
One
small
rechargeable
battery{
XE
"battery:recharging" }, one medium rechargeable
battery and one battery charger are provided with
the Argus II System. Follow the instructions
supplied with the charger to recharge the battery.
Additional batteries may be purchased from
Second Sight.
Checking the Function of the Device
It is important that you periodically check the
Argus II System for normal wear and tear. If you
notice any exposed wires on the glasses or loose
or broken parts{ XE "broken parts" } on the glasses
or VPU, contact your doctor. In addition, if you
Chapter 4: Using Your Device
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notice a decline in the link between the implant
and glasses (for example, if the RF link alarm is
beeping more frequently than normal), contact
your doctor.
Cleaning
To clean the battery{ XE "battery:cleaning" }
contacts, follow the instructions in the battery
package.
To clean your VPU{ XE "VPU:cleaning" }, glasses{
XE "glasses:cleaning" } or cables, follow the
instructions below:
1. Use a can of compressed air to remove dust
and debris from the equipment. Use the
compressed air as directed by the
manufacturer.
2. Use a clean, slightly damp cloth to clean the
equipment. Gently rub the areas that require
cleaning.
3. Use a clean, dry cloth to dry the equipment
after cleaning it.
4. Use a soft cloth to remove minor smudges
and fingerprints from the glasses and camera
lens on the glasses.
CAUTION: Do not use any cleaning
solutions or solvents to clean the
equipment as this may damage the
equipment or its labels.
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Maintenance
The Argus II System{ XE "glasses:maintenance" }{ XE
"VPU:maintenance" } does not contain any user
serviceable parts.
CAUTION: If your VPU or glasses are not
working properly, contact either your
clinician or Second Sight for assistance.
Do not try to fix the equipment yourself
as you may experience an injury, violate
the product warranty, or damage the
equipment.
Handling and Storage
Take care when storing and handling the VPU{ XE
"VPU:handling and storage" } and glasses{ XE
"glasses:handling and storage" }. Improper care or
storage can result in damage to the equipment.
Following the guidelines below can improve the
lifetime of this equipment.
1. Magnetically-sensitive storage devices{ XE
"magnetically-sensitive storage devices" }. Do
not place magnetically-sensitive storage
devices near the Argus II System while it is
operating. Examples of these storage devices
include credit cards, computer floppy disks and
hard disks.
The electromagnetic field
generated by the Argus II System may damage
Chapter 4: Using Your Device
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or erase the information that is stored on
magnetically-sensitive storage devices.
2. Metal objects{ XE "metal objects" }. Do not
allow any metal objects within 6 inches (15.2
cm) of the glasses coil while the VPU is in use.
If metal objects get too close to the coil, the coil
could overheat, which would cause the VPU to
turn off. The VPU will not work until reset by
trained personnel.
XE
3. Unapproved
components{
"glasses:unapproved
componenets"
}{
XE
"VPU:Unapproved components" }. Use only
components and accessories supplied by
Second Sight with the Argus II System. If you
use unapproved components, you may
damage the equipment, resulting in loss of
stimulation and/or injury. If you use
unapproved components, you will also void the
manufacturer’s warranty.
4. Exposure to liquid{ XE "glasses:exposure to
liquid" }{ XE "VPU:exposure to liquid" }. Do not
expose the VPU and glasses to water (for
example, rain, shower, swimming pool, or
ocean) or other liquids. Liquids may damage
the VPU or glasses. The glasses may be
exposed to light rain, but the VPU may not.
5. Storage{
XE
"glasses:storage"
}{
XE
"VPU:storage" } of the Argus II VPU and
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Glasses. Store the packaged Argus II VPU
and glasses at temperatures between 32°F
(0°C) and 113°F (45°C). Do not expose the
VPU and Glasses to temperatures below 32°F
(0°C) or above 113°F (45°C) as this may
damage the Glasses or VPU.
6. Usage temperature range{ XE "VPU:usage
temperature range" }{ XE "glasses:usage temperature
range" }. The temperature range for normal use
should be between 32°F (0°C) and 104°F
(40°C).
7. Handling{ XE "glasses:handling" } the glasses.
The glasses are fragile. Handle them with care,
especially when putting them on or taking them
off. Do not over-extend the arms of the glasses
when putting them on or taking them off as this
may break them. Do not fold the arms of the
glasses to shut them since trying to fold them
may break them. Use care when attaching or
removing any cables or plugs as rough
handling can damage the cables or equipment.
Do not wrap the cable around the VPU since,
over time, this may damage the cable.
8. Traveling{ XE "travel" } with the external
devices. Store the VPU, glasses, and batteries
in the travel case provided by Second Sight as
this is designed to protect the equipment.
Uninstall the battery from the VPU during
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transit, to avoid accidentally turning on the
VPU which could drain the battery. Do not
place anything on top of the glasses or VPU.
9. Loss of RF link. The coil on the Glasses
powers the implant.{ XE "VPU:loss of RF link" }
Moving the coil on the glasses more than
approximately 1 inch (2.5 cm) away from the
Implant may result in a decrease or loss of
stimulation. Additionally, you may need to
restrict your eye movements to maintain the
link between the implant coil and glasses coil.
10. Interference{ XE "interference" }. The Argus II
System may interfere with certain radio
frequencies. If interference occurs, you should
extend the distance between you and the
source of interference, or turn off the Argus II
VPU.
Expected Failure Time and Mode and Its
Effect on You
The Argus II Implant was designed to operate for
at least five years. Laboratory testing has
demonstrated that the implant should last that
long. Insufficient time has elapsed in actual clinical
use to provide proof that the device will function
properly for more than five years, but performance
to date and laboratory testing suggest that it will.
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One possible failure mode of the implant is that it
could stop responding to signals from the glasses
and thus stop stimulating. If it fails in this manner,
you should not experience any harmful effects.
The implant may be removed and replaced, if
desired.
The VPU and glasses are much more susceptible
to handling and breakage than the implant. This
equipment may be replaced if necessary.
Wearing out of the rechargeable battery is
described in the “Operating Instructions” section of
this chapter.
How to Safely Dispose of the Device
Follow the safety precautions below when you are
transporting, storing or disposing of any
components of the Argus II System. During
transport, storage and handling for disposal, the
following safety precautions should be considered:
WARNING
Do not dispose of the VPU
batteries{ XE "battery:disposal,
handling, storage and transport" }
or battery charger in a fire as this
may cause an explosion and/or the
release of toxic fumes.
Do not dismantle the battery as
some
ingredients
can
be
Chapter 4: Using Your Device
Page 85
flammable or harmful.
Store used batteries for disposal in
a clean dry environment out of
direct sunlight and away from
extreme heat.
WARNING
Dirt and wetness may cause shortcircuits and heat. Heat may cause
leakage of flammable gas which
may result in fire, rupture or
explosion.
Store used batteries in a wellventilated area. If used batteries
are short-circuited, abnormallycharged
or
force-discharged,
leakage of flammable gas may be
caused possibly resulting in fire,
rupture or explosion.
Do not mix used batteries with
other materials. If the batteries are
short-circuited,
abnormallycharged or force-discharged the
heat
generated
may
ignite
flammable wastes and cause a fire.
VPU and Glasses
Follow local and state regulations regarding the
proper disposal of electronics to dispose of the
Chapter 4: Using Your Device
Page 86
VPU{ XE "VPU:disposal" } or glasses{ XE
"glasses:disposal" }. If you are exchanging or
replacing your equipment through your clinician,
your clinician will be responsible for following
these regulations.
Rechargeable Batteries and Battery Charger
The VPU uses rechargeable batteries. If you
detect any leakage of fluid from the battery, stop
using it and replace it with a new one. Dispose of
a battery{ XE "battery:disposal" } or battery charger{
XE "battery charger:disposal" } when it reaches the
end of life. Follow procedures that comply with
your local regulations and the package insert of
the battery or battery charger for proper disposal
methods.
Argus II Explant
If you have the Argus II Implant{ XE "implant
disposal" } explanted{ XE "explant" } for any
reason, contact Second Sight immediately except
in the event of medical emergency. Your doctor
must return the explanted device to Second Sight
for evaluation, warranty purposes and final
disposition. Your doctor should request a
biohazard (explant) kit from the Second Sight
office (see contact information in Chapter 7).
Disposal of Packaging Material
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Dispose of the shipping carton{ XE "packaging
material disposal" } and packaging materials for
the Argus II System components according to
local regulations.
Chapter 4: Using Your Device
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Chapter 5: Troubleshooting
If you encounter a problem with any part of your
Argus II System{ XE "troubleshooting" }, look for
the problem in Table 9 below. Instructions for how
to fix the problem are provided in the table.
If you cannot find the problem in the tables below
or if the recommendations do not fix the problem,
then contact your doctor or programming clinician
or use the information provided in Chapter 7 of this
manual to contact Second Sight.
CAUTION: If you encounter a clinical or
physical problem (such as eye pain{ XE
"pain" } or discomfort) related to the Argus
II System, please contact your doctor or
programming clinician immediately.
Table 9: Troubleshooting
Symptom
Cause and/or Corrective
Action
The VPU{ XE
"VPU:does not
1. Check that the battery
is installed properly. If
it is not installed
properly, refer to
instructions in Chapter
4, “Install the battery.”
start,
troubleshooting" }
does not start
Chapter 5: Troubleshooting
Page 89
Symptom
The VPU does
not start
(continued)
The VPU
produces an
audible warning{
XE "VPU:produces
an audible warning"
} (three short
beeps) and
shuts off
suddenly
Cause and/or Corrective
Action
2. Install a fully-charged
battery. Refer to
instructions provided in
Chapter 4, “Install the
battery.”
3. Ensure that you are
pressing the correct
button. The power
button is the circularshaped one on the
right side panel of the
VPU (see Figure 3).
4. Ensure that you are
pressing the power
button for at least two
seconds. If the button
is pressed for less than
two seconds, the VPU
will not turn on.
5. Turn on the VPU to
see if this occurs
again. If the problem
persists, contact either
your clinician or your
Second Sight
representative.
Chapter 5: Troubleshooting
Page 90
Symptom
Cause and/or Corrective
Action
The VPU
shuts off
suddenly{ XE
"VPU:shuts off
suddenly" }
without an
audible
warning
1. Install a fully-charged
battery. Refer to
instructions “Install the
battery” provided in
Chapter 4.
2. Turn on the VPU to
see if this occurs
again.
3. If the VPU fails to
restart, remove the
battery for at least 5
minutes. Then, install
again.
4. Put on glasses. Turn
on the VPU again and
stimulation should
restart.
5. If the problem persists
or occurs again
randomly when the
battery is charged,
contact either your
clinician or your
Second Sight
representative for
advanced
troubleshooting.
Chapter 5: Troubleshooting
Page 91
Symptom
The VPU is
on, but I don’t
see anything{
XE "VPU:VPU
is on, but I
don’t see
anything" }
Cause and/or Corrective
Action
1.
Confirm that the VPU
is on by pressing any
button on the VPU
other than the power
button. If a beep is
heard, then the VPU is
on.
2. Ensure that the VPU is
not making any audible
alarms. Check if the
audible RF link alarm
switch is on. If it is,
check that the glasses
cable is properly
plugged into the VPU
glasses receptacle.
3. Gently press the coil
mounted on the
glasses closer to your
eye. If the audible
alarm stops beeping
and resumes beeping
when you stop
pressing the coil, this
indicates that your
external coil needs to
be adjusted to ensure
the communication
Chapter 5: Troubleshooting
Page 92
Symptom
Cause and/or Corrective
Action
4.
The VPU is
on, but I don’t
see anything
(continued)
5.
6.
7.
8.
between the external
coil and the implant is
reliable.
Ensure that nothing is
blocking the camera
on the glasses. If there
is something blocking
the camera, try to
remove the
obstruction.
Ensure that the lens on
the camera is clean.
Refer to “Cleaning” in
Chapter 4.
Ensure that your
surroundings have
adequate lighting.
Try inverting the image
(from black-to-white or
white-to-black) by
pressing the squareshaped settings
button.
Try changing the
program setting.
Chapter 5: Troubleshooting
Page 93
Symptom
Cause and/or Corrective
Action
The VPU is
on, but the
image seems
distorted{ XE
"VPU:is on,
but the image
seems
distorted" }
1. Ensure that nothing is
blocking the camera
on the glasses.
2. Ensure that the lens on
the camera is clean.
Refer to Chapter 4,
“Cleaning.”
3. Try using one of the
other program settings
to see if there is an
improvement.
The VPU is
on, but my
perception is
dimmer than
usual{ XE
"VPU:is on,
but my
perception is
dimmer than
usual" }
1. Ensure that nothing is
blocking the camera
on the glasses. If there
is something blocking
the camera, try to
remove the
obstruction.
2. Ensure that the lens on
the camera is clean.
Refer Chapter 4,
“Cleaning.”
3. Ensure that your
surroundings have
adequate lighting.
4. Ensure that you are
using the correct
stimulation setting.
Chapter 5: Troubleshooting
Page 94
Symptom
The VPU is
on, but my
perception is
dimmer than
usual
(continued)
The coil on
the glasses
seems
warmer than
usual{ XE
"glasses:coil
seems
warmer than
usual" }
Cause and/or Corrective
Action
Switch between the
normal/invert settings
by pressing the
square-shaped invert
button.
5. Ensure that the
intended Program
Setting is being used
to provide the optimum
perception by
experimenting with the
different Program
Setting buttons.
6. Switch off the VPU for
10 minutes and switch
it back on.
7. Re-adjust the glasses
to see if the coil cools
down to its usual
operating temperature.
If the problem is
persistent or the coil is
getting unusually
warm, contact Second
Sight using the contact
information provided in
Chapter 7.
Chapter 5: Troubleshooting
Page 95
Symptom
Cause and/or Corrective
Action
There is a
clicking noise{
XE
"glasses:clicki
ng noise" }
from the area
of the coil on
the glasses
8. This is part of the
normal operation of the
glasses and does not
indicate a failure of any
kind.
Nosepiece
comes off the
glasses{ XE
"glasses:nose
piece" }
1. Turn the glasses over
and lay them on a flat
surface so that the top
of the frame is in
contact with surface.
2. Take the nosepiece and
place it on the
underside of the lens
where the nosepiece
should be attached.
3. Press firmly. This
should lock the
nosepiece back in
place.
If the problem persists, contact your clinician or
use the information in Chapter 7 to contact
Second Sight.
Chapter 5: Troubleshooting
Page 96
Table 10: Indicator Lights
Symptom
Cause and/or Corrective
Action
The green
light is not
blinking
1. Change to a fully
charged battery{ XE
"VPU:indicator lights,
troubleshooting" }.
2. Turn off the VPU and
turn it back on again to
see if the problem is
fixed. If it is not fixed
then contact Second
Sight using the contact
information provided in
Chapter 7.
The orange
light turns on
(loss of video
signal)
1. Ensure that the green
light is still blinking.
2. Check that the glasses
cable is properly
connected to the glasses
receptacle on the VPU.
Refer to Chapter 4,
“Connecting the glasses
to the VPU.”
The amber
light turns on
(loss of RF
link)
1. Ensure that the green
light is still blinking.
2. Re-adjust the glasses to
see if the light turns off.
3. If step 2 does not fix the
Chapter 5: Troubleshooting
Page 97
Symptom
The amber
light turns on
(loss of RF
link,
continued)
Cause and/or Corrective
Action
problem, check that the
glasses cable is properly
connected to the glasses
receptacle. Refer to
Chapter 4, “Connecting
the glasses to the VPU.”
4. You may need to restrict
your eye movement to
maintain the link
between the implant coil
and the glasses coil.
If the problem persists, contact your programming
clinician or use the information in Chapter 7 to
contact Second Sight.
Table 11: Audible Alarms{ XE "VPU:audible
alarms, troubleshooting" }
Symptom
Cause and/or Corrective
Action
The VPU
shuts off
suddenly
emitting three
short beeps
(error-induced
VPU
Try powering up the VPU to
see if this occurs again. If
the VPU continues to shut
itself off, contact your
programming clinician. You
may also contact Second
Sight using the contact
Chapter 5: Troubleshooting
Page 98
Symptom
Cause and/or Corrective
Action
shutdown)
information provided in
Chapter 7.
The VPU
emits the
following
periodic
beeping
pattern:
3 short beeps
followed by 1
long beep,
followed by
3 short beeps,
followed by a
long pause
(low battery
voltage
warning)
1. Turn off the VPU.
2. Install a fully-charged
battery onto the VPU.
Refer to instructions
provided in Chapter 4,
“Install the battery.”
3. Power up the VPU;
allow the VPU to finish
the start-up test and
ensure the same
beeping pattern does
not occur after the
start-up test.
The VPU
emits a slow
periodic beep
once every
2 seconds
(loss of video
signal)
1. Ensure that the green
light is still blinking
approximately 1 blink
per second.
2. Check that the glasses
cable is properly
connected to the
glasses receptacle on
the VPU. Refer to
Chapter 4, “Connecting
Chapter 5: Troubleshooting
Page 99
Symptom
Cause and/or Corrective
Action
the glasses to the
VPU.”
The VPU
emits fast
periodic
beeps about 2
per second
(loss of RF
link)
1. Allow the VPU to finish
the start-up test and
ensure that the green
light is blinking
approximately 1 blink
per second.
2. Re-adjust the glasses
and gently press the
external coil closer to
your eye to see if the
amber light turns off.
3. Limit your eye
movements and look
straight ahead.
4. If steps 2 and 3 are
unsuccessful in
correcting the problem,
check that the glasses
cable is properly
connected to the
glasses receptacle – if
not, follow instructions
in Chapter 4,
“Connecting the
glasses to the VPU.”
5. This fast periodic
Chapter 5: Troubleshooting
Page 100
Symptom
The VPU
emits fast
periodic
beeps about 2
per second
(loss of RF
link,
continued)
The VPU is
not operating
as intended,
but I do not
hear any
audible
alarms
Cause and/or Corrective
Action
beeping related to the
temporary loss of
communication with the
implant can be turned
off by pressing the starshaped switch on the
right side of the VPU.
Press the star-shaped
audible RF link alarm
switch to ensure the RF link
alarm is “on”.
If you still cannot hear any
audible alarms, a sighted
person should check
whether the amber or the
orange light is on. If not,
you will not hear any
audible alarms. If the
amber or the orange light is
on, ensure that the VPU is
within your normal hearing
range. To test it, you may
want to put it next to your
ear.
Chapter 5: Troubleshooting
Page 101
Symptom
Cause and/or Corrective
Action
The VPU
operates as
intended, but I
hear an
unexpected
audible alarm
1. Refer to Table 6 from
Chapter 4 of the
manual for an
explanation of the
audible alarms.
2. If you still cannot
recognize the audible
indicator, turn off the
VPU and try turning it
on to see if this sound
occurs again.
3. Install a fully-charged
battery. Refer to
instructions provided in
Chapter 4, “Install the
battery.”
If the problem persists, contact your programming
clinician or use the information in Chapter 7 to
contact Second Sight.
Chapter 5: Troubleshooting
Page 102
Chapter 6: Additional information
Clinical Studies{ XE "clinical trial" }
Introduction
Second Sight performed a clinical study to test the
Argus II System. In this study, thirty subjects were
implanted with the Argus II Implant. Fourteen of
these subjects lived in the United States and
sixteen lived in Europe.
As of March 2012, subjects had been implanted
for an average of 3.5 years. The shortest length of
implant was 1.2 years and the longest length of
implant was 4.8 years.
One subject had the Argus II Implant removed at
1.2 years after implant due to a complication. The
Argus II Implant failed in one subject at 4 years
after implant. In the other 28 subjects, the Argus II
Implant was still implanted and working.
Side Effects and Complications
During the study, 28 of the 30 subjects
experienced at least one side effect or
complication related to the Argus II System or the
surgery to implant the device. Two subjects had
no side effects.
Chapter 6: Additional Information
Page 103
Of the 28 subjects, 17 had non-serious side
effects that either were treated with medication or
did not require any treatment at all. Six subjects
had one serious complication that was treated with
medication or a simple surgery (for example,
repairing a suture used to close the wound in the
eye). Five subjects had multiple serious
complications, some of which were treated with
surgery. Of these last five subjects, four had a
“cascade” of events, meaning that one
complication led to another complication.
Serious Complications
Below is a list of the serious complications{ XE
"clinical trial:serious complications" } during the study. Of
the 30 subjects:
• 4 subjects had a decrease in the pressure
of the eye, making the eye soft
• 3 subjects had an opening of the surgical
wound where the eye tissue covers the
implant.
• 3 subjects had a portion of the implant wear
through the tissue that covers it, leaving
that part of the implant uncovered.
• 3 subjects had an infection{ XE "infection" }
in the eye
• 2 subjects had a partial separation of their
retina from the eye wall
• 2 subjects had their retinal tack come out of
the retina requiring a re-tack procedure
Chapter 6: Additional Information
Page 104
•
•
•
1 subject had a thinning and clouding of the
cornea caused by an infection in the cornea
1 subject had an infection in the front
chamber of the eye
1 subject experienced a tear in his retina
Serious complications were treated with surgery,
unless they were a severe infection. Severe
infections were treated by either giving the subject
a shot of medication into the eye or by giving the
subject medicated eye drops.
As mentioned above, some subjects had several
serious complications. More than half of the
serious complications happened within 6 months
of implant surgery, although two happened as late
as 2 years after implant.
Other Side Effects
Below is a list of other side effects{ XE "clinical
trial:other side effects" } that occurred during the study
as of March 2012. Some of these side effects
needed no treatment and others were treated with
medication. Some subjects had several of these
side effects. Of the 30 subjects:
o 11 subjects had a thin layer of tissue grow
on the retina
o 10 subjects had redness of the conjunctiva
Chapter 6: Additional Information
Page 105
o 9 subjects had pain{ XE "pain" } in or
around the eye
o 9 subjects had swelling of the retina
o 7 subjects had surgery to adjust the
position of the implant in the eye to improve
how well it worked
o 7 subjects had a decrease in the pressure
of the eye, making the eye soft
o 6 subjects had irritation caused by the
sutures
o 6 subjects had fluid collected under the
choroid
o 4 subjects had redness or irritation of the
conjunctiva (“pink eye”)
o 9 subjects had redness or irritation inside
the eye
o 4 subjects had bleeding in the back part of
the eye
o 3 subjects had blood in the front of the eye
o 3 subjects had headaches
o The following side effects occurred in 2
subjects each:
o Increase in pressure of the eye{ XE
"pressure of the eye" }
o Blood vessels growing on the cornea
o Watering eye
o “Threads” on the cornea
o Redness and irritation due to
deposits on the cornea
o The following side effects occurred in 1
subject each:
Chapter 6: Additional Information
Page 106
o Large-scale growth of cells in the
eye that pulled on the retina
o Growth of strands of tissue that
pulled on the inner lining of the eye
o The feeling that something is in the
eye
o Build-up of fluid in the choroid
o Scar tissue inside the eye
o Scar tissue around the tack used to
hold the implant to the retina
o Cyst{ XE "cyst" } on the conjunctiva
o An opening of the surgical wound
where the eye tissue covers the
implant
o A portion of the implant wore through
the tissue that covers it, leaving that
part of the implant uncovered.
o Scraping of the cornea
o Dryness of the cornea
o Rough spot on the cornea
o Folding of the cornea
o Torn suture
o Decrease in how much light the
subject could see
o Increase
in
uncontrolled
eye
movements
o Drooping of the eyelid
o Fluid causing partial separation of
the retina from the choroid
Chapter 6: Additional Information
Page 107
o Partial separation of the retina from
the choroid due to pulling or
shrinking of the retina
o Folds in the retina
o Splitting of the layers of the retina
o Growth of blood vessels in the iris
o Movement of the tissue patch used
to cover the implant
o Redness and irritation of the sclera
o Eyelash below the conjunctiva
o Nausea
o Dizziness
Device Function
During the clinical trial{ XE "clinical trial" }, most
subjects experienced changes in the number of
electrodes that were programmed in the VPU. As
of March 2012, this number ranged from as few as
8 electrodes in some subjects to as many as 60
electrodes in other subjects. The average number
of electrodes programmed for stimulation in the
VPU was 38.
The stimulation limit was lower for home use than
for clinical testing.
Because of this, some
electrodes that were programmed for stimulation
in the VPU were not able to independently
produce light perception during home use. As of
March 2012, the number of electrodes that
produced light perception when they were
stimulated one-at-a-time at the lower home use
Chapter 6: Additional Information
Page 108
level ranged from 0 electrodes in some subjects to
as many as 60 electrodes in other subjects. The
average number of electrodes that produced light
perception when they were stimulated one-at-atime at the lower home use level was 13.4.
During the clinical trial{ XE "clinical trial" }, 13
subjects had fewer than 20 electrodes that
produced perception of light when stimulating one
electrode at a time. 8 of these 13 subjects did not
have any individual electrodes that, on their own,
produced perception of light. The clinician
changed the VPU programming to quad
stimulation in some of these subjects in order to
allow them to have perception over a larger part of
the electrode array. Refer to page 63 for a
description of quad stimulation. As of March 2012,
6 of these 13 subjects were using quad
stimulation. In the clinical trial, no attempt was
made to directly compare whether quad
stimulation provided better vision than single
electrode stimulation.
Chapter 6: Additional Information
Page 109
Probable Benefit
Tests of Vision
All 30 subjects were able to see spots of light
when the Argus II System{ XE "probable benefit" }
was on.
All 30 subjects did better on tests of their vision
when they were using the Argus II System
compared to when they were not using the
System. However, the extent that each subject’s
vision improved varied. Three tests were used to
measure subjects’ vision with the Argus II System.
In the first test, called “Square Localization,”
subjects had to touch a white square that
appeared on a black computer screen. On
average, subjects did better on this test with the
Argus II System on versus when the System was
off at each time point. At one year after implant,
15 of 16 subjects tested did better on this test with
their Argus II System on versus with the System
off.
The second test was harder than the first test. In
the second test, called “Direction of Motion,”
subjects watched a computer screen where a
white bar moved across the screen in different
directions. Subjects had to draw on the screen the
direction that they thought the bar was moving. On
average, subjects did better on this test with the
Chapter 6: Additional Information
Page 110
Argus II System on versus off at each time point.
At one year after implant, 10 of 16 subjects did
better on this test with their Argus II System on
versus with the System off.
The third test was the hardest of the three tests. In
the third test, called “Grating Visual Acuity,” black
and white stripes with decreasing width were
shown on a computer screen. The stripes were
drawn in one of four directions, either up and
down, left to right, diagonally to the left or
diagonally to the right. Subjects had to say which
direction the stripes were drawn. When using the
Argus II System, 8 of the 30 subjects could
correctly tell the direction of the stripes. When not
using the Argus II System, none of the subjects
could do this test correctly.
Line and Door Tests
The line and door tests were used to test how well
subjects could follow a white line on the ground
and find the door in a room. At every follow-up visit
after implant, subjects were better at doing these
tasks when using the Argus II System versus
when they were not using the Argus II system.
Use of Argus II System in Daily Life and Quality of
Life
Subjects completed two surveys to measure the
effect of the Argus II System on their quality of life
Chapter 6: Additional Information
Page 111
and their everyday life. One survey, the Massof
Activity Inventory, showed that during the study,
subjects reported a small improvement in how
easy it was for them to do everyday tasks. The
other survey showed no change in quality of life
during the study.
A low-vision therapist also spoke with the subjects
and visited their homes to judge what affect the
Argus II System was having on subjects’ lives.
These therapists found that 20 of the 26
participating subjects received benefit from the
Argus II System, while the remaining 6 subjects
were not getting benefit from the system.
Conclusions
The results of this clinical study showed that the
probable benefits of the Argus II System are
greater than its risks for patients with loss of vision
due to retinitis pigmentosa.
Chapter 6: Additional Information
Page 112
Information about Retinitis Pigmentosa
Retinitis pigmentosa{ XE "retinitis pigmentosa" }
(RP) is an eye disease which causes damage to
the retina. This damage results in a loss of vision.
The retina is the layer of tissue at the back of the
inside of the eye. The cells in the retina convert
light into signals to nerve cells which send signals
to the brain. The brain then tells us what we see.
The disease is named for the dark deposits which
appear in the retina.
RP can be caused by a genetic defect which will
cause it to run in families. Early symptoms of the
disease often are first experienced in childhood
(loss of the ability to see at night or in very low
light). Later the disease may lead to blurring of
vision, tunnel vision, loss of central vision or loss
of the ability to see colors. In many cases, these
severe vision problems do not occur until early
adulthood. In advanced stages of the disease, RP
can lead to a person being able to see only very
bright flashes of light. In the worst case, the
person may experience total blindness.
Chapter 6: Additional Information
Page 113
Warranty
Argus II Limited
Prosthesis (Implant)
Warranty
on
Retinal
This warranty{ XE "warranty" } applies to a person
implanted with an Implant (You). This warranty is
provided by Second Sight Medical Products, Inc.
(Us, We, or Our).
If an Argus II Implant stops working within 3 years
from the date of implant, due to Our not making
the Argus II Implant within specifications, We will
replace Your Implant. This warranty is limited to
Implant failures. This warranty does not apply to
failures due to surgical problems. This warranty
does not apply to failures due to Your medical
condition. An Implant failure must be confirmed by
Us before it is explanted.
WARRANTY DISCLAIMER:
WE EXPRESSLY DISCLAIM ALL IMPLIED
WARRANTIES, INCLUDING BUT NOT LIMITED
TO THE WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR ANY PURPOSE. WE WILL
NOT BE LIABLE FOR ANY DIRECT,
CONSEQUENTIAL OR INCIDENTAL DAMAGES
CAUSED BY THE IMPLANT’S FAILURE TO
FUNCTION
WITHIN
THE
NORMAL
TOLERANCES WHETHER THE CLAIM IS
Chapter 6: Additional Information
Page 114
BASED ON WARRANTY, CONTRACT, TORT
OR OTHERWISE.
If we choose, we may replace the Implant even if
the failure is not covered.
Argus II Limited Warranty on External Devices
External Devices include the video processing unit
(VPU), glasses, battery, battery charger base and
battery charger AC adaptor.
We warrant that the Argus II VPU and Glasses will
be free from defects in workmanship and materials
for 1 year from the date of first VPU fitting (or date
of purchase if bought separately).
We further warrant that the supplied battery
charger and rechargeable batteries are free from
defects in workmanship and materials for 3
months from the date of first VPU fitting (or time of
purchase if bought separately).
The battery
charger includes the charger base and AC
adaptor.
We will repair or replace a defective External
Device, or at Our option, provide full credit equal
to the purchase price of the defective External
Device. You may apply the credit towards the
purchase of replacement components.
WE EXPRESSLY DISCLAIM ALL IMPLIED
WARRANTIES, INCLUDING BUT NOT LIMITED
Chapter 6: Additional Information
Page 115
TO THE WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR ANY PURPOSE.
Product claims under Our Limited Warranty on
External Devices are subject to the following
conditions:
1. The product registration forms for the VPU
and glasses must be completed and returned
to Us within 30 days of first programming or
receipt of the product.
2. Warranty claim items must be returned to Us
within 30 days after receipt of replacement
part(s).
3. We must be able to confirm the failure.
4. This warranty excludes defects caused by:
fire, floods, lightning, natural disasters and
other calamities defined as “Acts of God;”.
This warranty excludes defects caused by
accident, misuse, abuse, negligence, water
damage, improper fitting or failure to operate
the External Device according to Our
instructions. This warranty excludes defects
caused by wear and tear resulting in cosmetic
or exterior damage. This warranty excludes
defects caused by attempts to repair,
maintain, or modify the equipment by You or
anyone else. This warranty excludes defects
caused by attachment of an External Device
Chapter 6: Additional Information
Page 116
to any device not supplied by Us without Our
prior approval. This warranty excludes defects
caused by cable breakage. Appropriate care
should be taken to prevent forces from
damaging cables. This warranty excludes
defects caused by battery cell depletion, which
may occur during the warranty period and is
not considered a defect in workmanship or
material—The batteries have a specified
capacity, which may deplete at different rates
depending on the settings used and failure to
recharge as specified in the operator’s
manual. Note: Per operator instructions,
batteries should be used promptly after
receipt, should not be stored for future use,
periodically recharged and must be kept within
temperature range. This warranty excludes
defects caused by accessories not listed with
this limited warranty.
5. For a replacement component the warranty
will run only to the warranty period for the
original component that was purchased by
You.
The terms and conditions of this warranty
limitation may be different in each country
depending on local laws.
For information on Our warranties or if You believe
a device is not working properly, please contact
Us using the contact information in Chapter 7.
Chapter 6: Additional Information
Page 117
Chapter
7:
Information
User
Assistance
Second Sight Medical Products welcomes your
comments about the Argus II Retinal Prosthesis
System or your suggestions to improve the
product. Please feel free to contact us for technical
assistance,
replacement
parts,
or
your
suggestions.
Second Sight Medical Products, Inc.
12744 San Fernando Road, Building 3
Sylmar, CA 91342 USA
Phone: +1 818 833 5000
Fax: +1 818 833 5067
E-mail: service@2-sight.com
www.2-sight.com
Chapter 7: User Assistance
Page 118
Write important telephone numbers here
Resource
Telephone number:
Clinic
Physician
Device disposal
contact:
Chapter 7: User Assistance
Page 119
Chapter
8:
Symbols
Regulatory Classifications
and
Symbols
The following symbols{ XE "symbols" } appear on
components of the Argus II System. The symbols
and their meanings are described below.
Table 12: Symbols
Symbol
Meaning
Catalog number
Serial number
Lot number
Date of manufacture
Warning and/or consult
accompanying documents
Storage temperature range
Keep Dry
Non-ionizing radiation
(Radio frequency radiation)
Chapter 8: Symbols and Regulatory
Classifications
Page 120
Symbol
Meaning
Manufactured by
Type B Applied Part
MR Conditional
MR Unsafe
Chapter 8: Symbols and Regulatory
Classifications
Page 121
Regulatory Classifications
The
Argus
II
System{
XE
"regulatory
classifications" } meets the requirements of several
international standards and directives. The table
below indicates how the Argus II System is
classified according to each of these standards
and directives. For detailed information regarding
electromagnetic
environments,
please
see
Appendix B.
Table 13: Regulatory Classifications
Standards /
Directives
IEC 60601-1
Regulatory
Classifications
Classification:
Internally Powered
Type B Applied Part
IPX0 Continuous
Operation
Chapter 8: Symbols and Regulatory
Classifications
Page 122
Standards /
Directives
IEC 60601-1-2
Classifications
(CISPR 11
Electromagnetic
Emissions)
Regulatory
Classifications
Classification:
Group 1 Equipment
Equipment in which
there is intentionally
generated and/or used
conductively coupled
radio frequency
energy which is
necessary for the
internal functioning of
the equipment itself.
Therefore, its RF
emissions are very low
and are not likely to
cause any interference
in nearby electronic
equipment.
Class B Equipment
Equipment suitable for
use in all
establishments
including your home.
Chapter 8: Symbols and Regulatory
Classifications
Page 123
Standards /
Directives
IEC 60601-1-2
(Electromagnetic
Immunity)
Regulatory
Classifications
Classification:
The Argus II System
may experience
interference from ESD{
XE "electrostatic
discharge (ESD)" },
power frequency
magnetic fields, and
conducted and radiated
RF.
Chapter 8: Symbols and Regulatory
Classifications
Page 124
Standards /
Directives
R&TTE Directive
Regulatory
Classifications
Classification:
Product Type 1 Inductive loop coil
transmitter tested with
an integral antenna
Receiver Class 2 Function critical Short
Range Device (SRD)
communication media;
i.e. when a failure to
operate correctly
causes loss of function
but does not constitute
a safety hazard.
Chapter 8: Symbols and Regulatory
Classifications
Page 125
Index
airplane · 42
airport · 39, 44
allergic reaction · 52
anesthesia · 28, 59
antibiotic · 28
battery · 19
battery life · 79
charging · 68
cleaning · 80
disposal · 87
disposal, handling, storage and transport · 85
installation · 68
latch · 69
recharging · 79
removal · 68
battery charger · 26
disposal · 87
bleeding · 53
bluetooth · 41
broken parts · 79
camera · 21
catalog numbers · 26
choroid · 1
clinical follow-up · 61, 62
clinical trial · 47, 56, 57, 58, 64, 65, 103, 108, 109
other side effects · 105
serious complications · 104
cobalt treatment · 38
computed tomography scan (CT scan) · 38
conjunctiva · 1, 51
contraindications · 28
Index
Page 126
cornea · 2, 53
cyst · 54, 107
decrease in light perception · 51
defibrillator · 38
detector
metal · 39
theft · 39, 67
device programming · 61, 62
diathermy · 29
dizziness · 54
drooping of the eyelid · 52
dry eye · 54
electric shock · 50
electroconvulsive therapy (ECT) · 29
electromagnetic interference (EMI) · 3, 33
electromagnetic environments · 138
index of potential effects · 133
electronic article
deactivator · 39
surveillance · 39
electrostatic discharge (ESD) · 3, 124
electrosurgical equipment · 31, 38
explant · 87
external equipment · 13
eyelash · 51
field of view · 56
follow-up programming · 65
fragmatome · 38
future treatments · 52
Index
Page 127
G
general anesthesia · 28
glasses · 20, 21, 26
cleaning · 80
clicking noise · 96
coil seems warmer than usual · 95
connecting · 70
disconnecting · 71
disposal · 87
exposure to liquid · 82
handling · 83
handling and storage · 81
maintenance · 81
materials · 20
nosepiece · 96
storage · 82
unapproved componenets · 82
usage temperature range · 83
wearing the glasses · 71
growth of cells · 50
hearing aids · 40
implant disposal · 87
indications for use · 7
infection · 49, 53, 61, 104
interference · 84
iris · 4
laser · 38, 50
limitations of the Argus II System · 55
linear acceleration · 38
lithotripsy · 30
Index
Page 128
M
magnetic resonance imaging (MRI) · 30, 37
MR conditional · 30
magnetically-sensitive storage devices · 81
materials in the glasses · 53
materials in the implant · 52
medical alert bracelet · 46
metal objects · 82
microwaves · 41
nausea · 54
over-stimulation · 52
packaging material disposal · 88
pain · 31, 32, 33, 48, 51, 61, 67, 89, 106
patient identification (ID) card · 44
phacoemulsification · 38
power generators · 42
pregnancy and nursing · 33
pressure of the eye · 106
probable benefit · 55, 58, 110
quad(s) · 63
Radio Frequency (RF) · 4
radiofrequency identification (RFID) · 39
regulatory classifications · 122
Index
Page 129
retina · 4
retinal tack · 50
retinitis pigmentosa · 113
risk · 47
Argus II specific · 48
possible "cascade" of events · 54
surgery · 47
sclera · 5
security screening · 39
skin burn · 50
static electricity · 40
steroid · 28
strabismus · 28
surgery · 59
suture · 48
symbols · 120
tear in the retina · 49
therapeutic ionizing radiation · 38
Transportation Security Administration (TSA) · 43
travel · 83
travel case · 22, 27
troubleshooting · 89
ultrasound · 30, 38
visual field · 56
visual rehabilitation · 61, 65
VPU · 5, 13, 15, 16, 26
audible alarms · 77
audible alarms, troubleshooting · 98
audible RF link alarm · 74
Index
Page 130
changing program settings · 74
cleaning · 80
connecting · 70
disconnecting · 71
disposal · 87
does not start, troubleshooting · 89
exposure to liquid · 82
handling and storage · 81
indicator lights · 76
indicator lights, troubleshooting · 97
invers setting button · 17
inverting the image · 74
is on, but my perception is dimmer than usual · 94
is on, but the image seems distorted · 94
loss of RF link · 84
maintenance · 81
produces an audible warning · 90
program setting buttons · 16
RF link alarm · 17
shuts off suddenly · 91
storage · 82
turning off · 75
turning on · 73
Unapproved components · 82
usage temperature range · 83
VPU is on, but I don’t see anything · 92
VPU battery · 26
VPU pouch · 27
warranty · 114
watering eye · 54
WiFi · 41
wireless router · 41
wireless technology · 23
wound · 49
Index
Page 131
Appendix A: Potential Effects of Electromagnetic Interference (EMI)
Information for Users (FCC Rules)
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) This device must accept any interference received, including
interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for Class B Digital Device, pursuant to Part 15 of
the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio communications. However, there is
no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures.
•
Reorient or relocate the receiving antenna
•
Increase the separation between the equipment and receiver
•
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected
Appendix A: Potential Effects of Electromagnetic Interference
Page 132
•
Consult the dealer or an experienced radio/TV technician for help
Any changes or modifications not expressly approved by Second Sight Medical Products, Inc. could void the user’s
authority to operate the equipment.
Table 14: Potential effects of EMI from devices or procedures
Device or procedure
Patient
injury
Potential Effect:
Damage Temporary
to the Interruption
Argus II
of
System Stimulation
Airport{ XE "electromagnetic
interference (EMI):index of potential
effects" } screening device
Bipolar electrosurgical equipment
✓
✓
Image
Artifacta
Additional
Information
Page 39
Page 38
Bluetooth device
✓
Page 41
Cell phones or cordless phones
✓
Page 41
Appendix A: Potential Effects of Electromagnetic Interference
Page 133
Device or procedure
Patient
injury
Potential Effect:
Damage Temporary
to the Interruption
Argus II
of
System Stimulation
✓
Computed tomography (CT) Scan
Commercial electrical equipment
(for example, arc welders
induction furnaces, resistance
welders, etc.)
Communication equipment (such
as microwave transmitters, linear
power amplifiers and high-power
amateur transmitters)
Defibrillator
Image
Artifacta
Appendix A: Potential Effects of Electromagnetic Interference
Page 38
✓
Page 42
✓
Page 42
✓
Diagnostic Ultrasound
Additional
Information
Page 38
✓
Page 38
Page 134
Device or procedure
Diathermy
Patient
injury
✓
Potential Effect:
Damage Temporary
to the Interruption
Argus II
of
System Stimulation
✓
Electroconvulsive therapy (ECT)
✓
✓
Electronic article surveillance
(EAS) systems and EAS tag
deactivators
✓
High output ultrasound
✓
✓
Appendix A: Potential Effects of Electromagnetic Interference
Page 39
Page 38
✓
Hearing aids
Page 42
Page 29
✓
Fragmatome
Additional
Information
Page 29
✓
Electric steel furnaces
Image
Artifacta
Page 40
Page 42
Page 135
Device or procedure
Patient
injury
Potential Effect:
Damage Temporary
to the Interruption
Argus II
of
System Stimulation
Image
Artifacta
Additional
Information
High voltage lines, power lines or
generators
✓
Page 42
Home appliances
✓
Page 41
Large magnetized speakers
✓
Page 42
✓
Laser
Lithotripsy
✓
✓
Magnetic resonance imaging
(MRI)
✓
✓
Page 38
Page 30
✓
Page 30
Metal detector
✓
Page 39
Microwave oven
✓
Page 41
Appendix A: Potential Effects of Electromagnetic Interference
Page 136
Device or procedure
Phacoemulsification
Patient
injury
Potential Effect:
Damage Temporary
to the Interruption
Argus II
of
System Stimulation
✓
Image
Artifacta
Additional
Information
Page 38
Radiofrequency identification
(RFID) systems
✓
Page 39
Theft detector
✓
Page 39
Therapeutic ionizing radiation to
the head
✓
Page 38
WiFi access point
✓
Page 41
Wireless router
✓
Page 41
If the medical procedure is being performed to evaluate the area where the Argus II Implant is
located, the implant may block or blur the image making it unreadable in this area.
Appendix A: Potential Effects of Electromagnetic Interference
Page 137
Appendix B:
Environments
Electromagnetic
XE "electromagnetic interference (EMI):electromagnetic
environments" } and manufacturer’s declaration – electromagnetic
Guidance{
emissions
The Argus II system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Argus II system should assure that
it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The Argus II system uses RF
energy only for its internal function.
Therefore, its RF emissions are
very low and are not likely to cause
any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not Applicable*
The Argus II System is suitable for
use in all establishments, including
domestic establishments and those
directly connected to the public
low-voltage power supply network
that supplies buildings used for
domestic purposes.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
Applicable*
* Not Applicable – The Argus II System is Battery Powered
Appendix B: Electromagnetic
Environments
Page 138
Guidance and manufacturer’s declaration – electromagnetic immunity
The Argus II system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Argus II system should assure that
it is used in such an environment.
IMMUNITY test
IEC 60601
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Compliance
level
Electromagnetic
environment –
guidance
± 6 kV contact
± 6 kV
contact
± 8 kV air
± 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
Not
Applicable
Surge
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not
Applicable
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
Not
Applicable
IEC 61000-4-11
70 % UT
(30 % dip in UT)
for 25 cycles
IEC 61000-4-5
test
40 % UT
(60 % dip in UT)
for 5 cycles
<5 % UT
(>95 % dip in UT)
Power frequency
(50/60 Hz)
magnetic field
3 A/m
3 A/m
IEC 61000-4-8
Power frequency
magnetic fields should be
at levels characteristic of a
typical location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Appendix B: Electromagnetic
Environments
Page 139
Guidance and manufacturer’s declaration – electromagnetic immunity
The Argus II system is intended for use in the electromagnetic environment specified
below. The customer or the user of the Argus II system should assure that it is used in
such an environment.
IMMUNITY
test
IEC 60601
Test Level
Compliance
level
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Argus II system, including cables,
than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.17 P
Conducted
RF IEC
61000-4-6
3 Vrms
150 kHz to
80 MHz
3V
Radiated
RF IEC
61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
d = 1.17 P 80 MHz to 800 MHz
d = 2.33 P 800 MHz to 2.3 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, object and people.
Appendix B: Electromagnetic
Environments
Page 140
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Argus II system is used exceeds the applicable RF compliance level above, the Argus II system
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Argus II System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the Argus II system
The Argus II system is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Argus II
system can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the Argus II System as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
Separation distance
according to frequency of
transmitter (m)
150 kHz to 80
MHz
80 MHz to 800
MHz
800 MHz to
2.5 GHz
d = [ 3.5] PV1
d = [ 3.5] PE1
d = [ 7 ] PE1
0.01
0.0117
0.0117
0.0233
0.1
0.117
0.117
0.233
1.17
1.17
2.33
10
11.7
11.7
23.3
100
117
117
233
(W)
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 applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 Hz, the separation distance for the higher frequency
range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects, and
people.
Appendix B: Electromagnetic
Environments
Page 141
Second Sight Medical Products, Inc.
12744 San Fernando Rd., Building 3
Sylmar, CA 91342, United States
Phone: +1 818 833 5000
Fax: +1 818 833 5067
E-mail: service@2-sight.com
Visit us at www.2-sight.com
Date of Issue: JUN-2013

---

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