® 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: [email protected] 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 ...................... 1 Indications for Use ............................................. 1 When the Device Should Not be Used (Contraindications) ............................................ 2 General Warnings and Precautions ................... 3 Warnings ........................................................ 3 General Precautions ....................................... 5 Electromagnetic Interference (EMI) ................ 6 Precautions Regarding Other Medical Procedures ..................................................... 8 Possible Interference with Other Electronic Devices ......................................................... 10 Your Patient Identification Card ....................... 13 Importance of Following a Care Regimen ........ 14 When to Call Your Doctor ............................. 15 Recovering From Surgery or Any Adverse Events ........................................................... 16 Risks and Benefits ........................................... 16 Risks of the Argus II System ......................... 16 Benefits and Limitations of the Argus II System ..................................................................... 21 Chapter 2: Device Description ......................... 23 Argus II Retinal Prosthesis (Implant) ............... 25 External Equipment ......................................... 27 Video Processing Unit (VPU) ........................ 27 Glasses ......................................................... 34 Argus II System Wireless Information ........... 38 Argus II Patient Catalog ................................... 40 Chapter 3: Preparing for Your Device ............. 43 Implantation Surgery........................................ 43 Post-Implant Care ............................................ 45 Clinical Follow-Up ......................................... 45 Device Fitting and Programming .................. 46 Visual Rehabilitation ..................................... 47 Chapter 4: Using Your Device ......................... 49 Setup Instructions............................................ 49 Operating Instructions ..................................... 53 LED Indicators and Audible Alarms .............. 56 Battery Life ................................................... 59 Recharging the Batteries .............................. 60 Checking the Function of the Device ............... 60 Cleaning .......................................................... 60 Maintenance .................................................... 61 Handling and Storage ...................................... 62 Expected Failure Time and Mode and Its Effect on You ............................................................. 65 Instructions on How to Safely Dispose of the Device ............................................................. 66 VPU and Glasses ......................................... 67 Rechargeable Batteries and Battery Charger ..................................................................... 67 Argus II Implant ............................................ 68 Disposal of Packaging Material .................... 68 Chapter 5: Troubleshooting ............................ 69 Chapter 6: Additional information .................. 83 Warranty .......................................................... 83 Symbols and Regulatory Classifications ......... 88 Chapter 7: User Assistance ............................. 93 Write your important telephone numbers here 94 Chapter 8: Glossary ......................................... 95 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 follow- up, 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