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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. ...»

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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 C3 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 © 2012 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: Important Information

Indications for Use

When the Device Should Not be Used (Contraindications)

General Warnings and Precautions

Warnings

General Precautions

Electromagnetic Interference (EMI)................ 6 Precautions Regarding Other Medical Procedures

Possible Interference with Other Electronic Devices

Your Patient Identification Card

Importance of Following a Care Regimen........ 14 When to Call Your Doctor

Recovering From Surgery or Any Adverse Events

Risks and Benefits

Risks of the Argus II System

Benefits and Limitations of the Argus II System

Chapter 2: Device Description

Argus II Retinal Prosthesis (Implant)............... 25 External Equipment

Video Processing Unit (VPU)

Glasses

Argus II System Wireless Information........... 38 Argus II Patient Catalog

Chapter 3: Preparing for Your Device............. 43 Implantation Surgery

Post-Implant Care

Clinical Follow-Up

Device Fitting and Programming.................. 46 Visual Rehabilitation

Chapter 4: Using Your Device

Setup Instructions

Operating Instructions

LED Indicators and Audible Alarms.............. 56 Battery Life

Recharging the Batteries

Checking the Function of the Device............... 60 Cleaning

Maintenance

Handling and Storage

Expected Failure Time and Mode and Its Effect on You

Instructions on How to Safely Dispose of the Device

VPU and Glasses

Rechargeable Batteries and Battery Charger

Argus II Implant

Disposal of Packaging Material

Chapter 5: Troubleshooting

Chapter 6: Additional information.................. 83 Warranty

Symbols and Regulatory Classifications......... 88 Chapter 7: User Assistance

Write your important telephone numbers here 94 Chapter 8: Glossary

Chapter 1: Important Information 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.

It is indicated for use in patients with severe to profound retinitis pigmentosa who meet the

following criteria:

• Are an adult, age 25 years or older.

• Have bare light or no light perception in both eyes. (If you do not have any remaining light perception, you will be tested to make sure that your eye will respond to electrical stimulation.)

• Were able to see objects, shapes and lines in the past.

• Have no lens or an artificial lens in the eye that will be implanted (If you have a natural lens in the eye that will be implanted, it will be removed during the implant surgery.)

• Are willing and able to receive the recommended post-implant clinical followup, device fitting and visual rehabilitation.

The Argus II implant will be implanted in only one eye, most likely the eye that has the worse vision.

Chapter 1: Important Information Page 1 When the Device Should Not be Used (Contraindications) You should not have the Argus II Retinal

Prosthesis implanted if you:

• Have an eye disease or condition that could prevent the Argus II System from working properly (for example, optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, or severe strabismus).

• Have an eye structure or condition (for example, a very long or very short eye, as measured from the front to the back of the eye) that could make it difficult to successfully implant the Argus II Implant or recover following surgery.

• Have eye diseases or conditions (other than cataracts) which make it difficult for your doctor to see inside your eye (for example, a cloudy cornea, etc.).

• Are unable to undergo general anesthesia or take the recommended antibiotic and steroid medications you will need to take before and after surgery.

• Have a metallic or active implantable device (for example, a cochlear implant) in your head.

Chapter 1: Important Information Page 2

• Have any disease or condition (for example, significant mental decline) that prevents you from understanding or giving your informed consent, from undergoing the programming the device after it is implanted, or from having medical followup. Your doctor may ask you to have a psychological evaluation to make sure you are qualified for this device.





• Tend to rub your eye a lot.

General Warnings and Precautions

Warnings

• If you have an Argus II Implant, do not undergo short wave or microwave 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.

• If you have an Argus II Implant, do not undergo electroconvulsive therapy (ECT) as ECT may damage your eye or your Argus II implant.

• If you have an Argus II Implant and need to undergo lithotripsy or high output ultrasound, inform your doctor that you have this implant. If you have an Argus II Chapter 1: Important Information Page 3 Implant, these treatments may harm you or damage the implant. Your doctor should contact Second Sight Medical Products for instructions in how to perform these procedures in someone who has an Argus II Implant.

• The Argus II Implant has been classified as an MR Conditional device. If you have an Argus II Implant, you may undergo a magnetic resonance imaging (MRI) procedure ONLY if it is performed using a

1.5 or 3.0 Tesla MRI System and ONLY following special instruction. Before having an MRI procedure, tell your doctor that you have the Argus II Implant. Your doctor should contact Second Sight Medical Products for instructions in how to perform an MRI in someone who has an Argus II Implant.

• If you have an Argus II Implant, you should not enter a room housing an MRI System that is not 1.5 or 3.0 Tesla, even if the Argus II System is not being used.

• The Argus II System may cause medical monitoring, diagnostic or life support equipment to function improperly. Do not use the Argus II System within 3 feet of this type of equipment. If someone notices that interference is occurring, turn off the Chapter 1: Important Information Page 4 Argus II VPU or extend the distance between yourself and the equipment.

• If you have an Argus II Implant do not receive treatment with monopolar electrosurgical equipment. Monopolar electrosurgical equipment may damage the implant or the tissue around the implant.

General Precautions

• If you experience any uncomfortable feeling while using the Argus II System (for example, pain), immediately stop using the system by removing the Argus II Glasses or by turning off the Argus II VPU.

• 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 in the future.

• Only use a VPU that has been specifically programmed for you by your clinician. Using someone else’s VPU may limit how well you see with the Argus II System and may cause you physical discomfort from overstimulation.

Chapter 1: Important Information Page 5

• Avoid physical impact or extreme direct pressure to the eye as this may result in injury to the eye, movement or damage to the Argus II Implant. If either of these occurs, contact your physician.

• Avoid rubbing the eye that has the implant as this may dislodge the implant or cause eye irritation.

• Even though you have the Argus II Implant, continue to use your other mobility aids (for example, canes, dogs, etc.) at all times.

• Use of the Argus II System during pregnancy and nursing has not been evaluated.

Electromagnetic Interference (EMI) Electromagnetic interference is a field of energy (electrical, magnetic, or both) created by 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 (Refer to “Symbols and Regulatory Classifications” on page 88 for more information). The Argus II System is designed to continue to operate in a “safe mode” in the presence of any electromagnetic Chapter 1: Important Information Page 6 interference that you would encounter during your normal every day 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 3.

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 3.

–  –  –

Interruption of Stimulation. EMI may cause a momentary interruption of stimulation.

If you enter an environment which maybe 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.

Chapter 1: Important Information Page 7

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.

Refer to the Precautions Regarding Other Medical Procedures, the Possible Interference with Other Electronic Devices, or the Travel or International Use sections of this manual for additional information regarding potential sources of electromagnetic interference and how to use your Argus II System in these environments.

–  –  –

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.

Remove the Argus II Glasses and VPU before having any medical or test procedure that involves the use of other medical equipment. Once the Chapter 1: Important Information Page 8 procedure is complete, you should have your Argus II Implant tested by your clinician as soon as possible to make sure it is still functioning properly.

• The use of laser, phacoemulsification, fragmatome may damage the Argus II Implant.

• The use of bipolar electrosurgical equipment may damage the Argus II Implant.

• You may undergo CT Scans or Diagnostic Ultrasound. However, if a scan or ultrasound is performed 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 defibrillators or 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 Argus II Implant should be tested as soon as possible following these procedures to determine whether the implant is still functioning properly. Damage to the implant may not be immediately detectable.

Chapter 1: Important Information Page 9

• The effects of cobalt treatment or linear acceleration techniques on the implant are unknown.

Possible Interference with Other Electronic Devices

• Theft or metal detectors (such as those located in entrances to public buildings and department stores) and airport or security screening devices may interfere with the Argus II System causing interruption of stimulation. When possible, it is best to avoid these devices or turn the VPU off when passing through these systems. You should show your patient identification card to any attendant in the area who may be able to assist you in bypassing these devices. If unavoidable, walk through the scanner and promptly move away from the area. Do not lean on these scanners or linger in their path.

• Static electricity may interfere with normal operation or cause damage to the Argus II System. Common situations that create static electricity include putting on or removing clothes, or dragging feet across a carpet or rug when there is very low humidity (for example, humidity below 30%). Static electricity can be removed by touching a metal object. Avoid handling the Chapter 1: Important Information Page 10 VPU and glasses if you think there is a lot of static electricity present.

• The Argus II System may interfere with the normal operation of some models of hearing aids. If you wear a hearing aid, you should have it tested with the Argus II System before you are implanted, to make sure both the hearing aid and Argus II System will function properly.



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