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Second Sight Argus 2s User Manual

Retinal prosthesis system
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Argus
2s
Retinal Prosthesis System
User Manual
095004-001 A
Rx Only: Federal law restricts this device to sale by or
on the order of a physician.
HUMANITARIAN DEVICE: Authorized by Federal
(U.S.) law to provide electrical stimulation of the retina
to induce visual perception in blind patients with severe
to profound retinitis pigmentosa and bare light or no
light perception in both eyes. The effectiveness of this
device for this use has not been demonstrated

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  • Page 1 ® Argus Retinal Prosthesis System User Manual 095004-001 A Rx Only: Federal law restricts this device to sale by or on the order of a physician. HUMANITARIAN DEVICE: Authorized by Federal (U.S.) law to provide electrical stimulation of the retina to induce visual perception in blind patients with severe to profound retinitis pigmentosa and bare light or no light perception in both eyes.
  • Page 3 Phone: +1 818 833 5060 Fax: +1 818 833 5067 E-mail: service@secondsight.com Visit us at www.secondsight.com Copyright © 2021 Second Sight Medical Products, Inc. Argus, Second Sight and the Second Sight Logo are registered trademarks of Second Sight Medical Products, Inc.

  • Page 5: Table Of Contents

    Table of Contents Chapter 1: Glossary ........... 1 Chapter 2: Descriptive Information ....6 Indications for Use ..........6 Device Description ..........7 When the Device Should Not be Used (Contraindications) .......... 27 General Warnings and Precautions....28 Your Patient Identification Card ....... 40 Risks and Probable Benefits ......
  • Page 6 Chapter 7: Contact Information..... 105 Chapter 8: Symbols and Regulatory Classifications ..........107 Symbols ............107 Regulatory Classifications ......109 Appendix A: Potential Effects of Electromagnetic Interference (EMI) ....113 Index ..............118...

  • Page 8: Chapter 1: Glossary

    Chapter 1: Glossary Term Definition Choroid A thin layer of cells between the retina and the sclera that contains pigments and blood vessels. The blood vessels bring oxygen and nutrients to the retina.(See Figure 1) Conjunctiva A thin layer of tissue that covers the white part of the eye and the inner surface of the eyelids.
  • Page 9 Term Definition Cyst A closed sack of abnormal tissue that may contain air, fluids, or semi-solid material. Diagnosis The identification of disease by its symptoms. Electrode Array A grid of electrodes used to stimulate the retina. Electrical A technique that uses Stimulation electrical currents to activate nerve fibers.
  • Page 10 Term Definition Incision The surgical cut created in your eye so that the Argus II Implant can be placed in your eye. Iris The iris is the round structure in the eye that gives the eye color. For example, blue-eyed people have a blue iris while brown-eyed people have a brown iris.
  • Page 11 (See Figure 1) Therapy Treatment of disease or disorders. VPU (Video The part of the Argus 2s Processing System that you carry. It Unit) processes the information that is sent to and from the implant inside your eye.
  • Page 12 Figure 1: Parts of the Human Eye Sclera Choroid Image courtesy of the National Eye Institute, National Institutes of Health Chapter 1: Glossary Page 5...

  • Page 13: Chapter 2: Descriptive Information

    The Argus 2s 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 2s system if you have severe to profound retinitis pigmentosa and you meet the following criteria: •...

  • Page 14: Device Description

    Your doctor will discuss with you which eye is best for the implant before your implant surgery. Device Description The Argus 2s Retinal Prosthesis System consists of the following main parts and accessories: • Argus II Retinal Prosthesis (Implant) •...
  • Page 15 Refer to the Appendices A for more information about interference with other electronic equipment. How Does the Argus 2s System Work? You will have the Argus II Retinal Prosthesis implanted in and around your eye. You must wear the glasses and turn on the VPU to use the system.
  • Page 16 Figure 2 shows how the implant 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, implant antenna and scleral band sit on the outside of the eye.
  • Page 17 Figure 2: Implant on a Right Eye (looking at your eyeball) Electronics Case Scleral Band (outside the eye) (outside the eye) Electrode Array Implant Coil Implant Antenna (inside the eye) (outside the eye) (outside Eye) Chapter 2: Descriptive Information Page 10...
  • Page 18 External Equipment – VPU and Glasses Figure 3: External Equipment Glasses Cable Glasses Camera Glasses Antenna (Left Eye) The VPU and glasses must be used together for the system to work. The VPU and glasses connect with a cable. One end of the cable plugs into the end of the arm of the glasses, the other end plugs into a port on the top of the VPU.
  • Page 19 The VPU keeps track of when you turn it on and off. It also keeps a record of how well your implant and VPU are working. 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.
  • Page 20 Figure 4: VPU Mute Button Power Button Volume Slider Program Selector Invert Selector Network RF Link Connection Loss/Camera Visual Indicator Loss Visual Indicator Loops for securing VPU Strap to VPU Micro USB Port Chapter 2: Descriptive Information Page 13...
  • Page 21 Network Connection Button Battery door Table 1 describes the parts of the VPU. Table 2 describes the accessories that you use with the VPU. Table 1: VPU Controls Control Description Power The power button is round and Button indented. With the front of the VPU facing you, the Power Button is located on the top right side of the VPU.
  • Page 22 Control Description The VPU can be set to have both audible and vibratory alerts, only Mute vibratory alerts or no alerts. Note Button that if the VPU is set to vibration (con't) alerts and no alerts, the audible alerts for low battery and VPU Error will still sound.
  • Page 23 Control Description Network The Network Connection button Connection is on the bottom left hand side Button of the VPU. Your clinician uses it during programming to start the connection between your VPU to the programming computer. Battery The battery door is on the Door bottom right hand side of the VPU.
  • Page 24 Second Sight. Battery The battery charger is used Charger to recharge the batteries provided with the Argus 2s system. Belt Holster The belt holster attaches to a belt so that the VPU can be worn at the waist.
  • Page 25 Accessory Description lengths. Glasses The glasses have a small video camera in the bridge above the nose. There is also a round antenna on one of the arms. The antenna will be either on the left or right arm depending on which eye is implanted.
  • Page 26 Figure 6: How to Use the Cable Clip a) Press to open the cable b) Push the cable into holder place and release c) Clip on clothes Chapter 2: Descriptive Information Page 19...
  • Page 27 Patient-Contacting Materials of the Glasses The glasses are mostly made of plastic and include the following materials: • Nylon • Silicone • PVC - Polyvinyl Chloride • PET - Polyethylene Terephthalate • Stainless Steel Table 3: Glasses Components and Accessories Component Description Camera...
  • Page 28 Component Description Glasses The glasses cable is used to Cable connect the glasses to the VPU. It comes in two lengths so that the VPU can be worn in different ways. Each end of the cable has a uniquely shaped connector so that it can only be attached in the correct way.
  • Page 29 VPU, glasses and batteries. Argus 2s System Wireless Information The Argus 2s Glasses use wireless technology to power the implant and to send and receive information from the implant. Table 4 below describes information about the wireless technology used in the Argus 2s system.
  • Page 30 Wireless Link In order for your Argus 2s system to work, the glasses must maintain the wireless link with the implant. For the wireless Chapter 2: Descriptive Information...
  • Page 31 link to work, the glasses antenna must be close to the implant. To make sure the system works properly, wear your glasses in the same position as they were during the programing session in the clinic. When the wireless link between the glasses and implant is lost, a tone will sound, and will continue to sound, until the wireless link is restored.
  • Page 32 Argus 2s Patient Devices The following items are included in your Argus 2s Retinal Prosthesis system: Table 5: Patient Devices Description Catalog / Product Number Argus 2s Video Processing Unit 013300-001 Argus 2s Glasses (only one): Glasses, Right Eye, Medium...
  • Page 33 Description Catalog / Product Number Dark Lenses, Large 012602-001 VPU Battery Charger 300300-209 (XTAR VC2 Plus Master) VPU Battery Charger Power 300300-210 Supply Rechargeable VPU Batteries (4) 013400-001 Glasses Cables, 1 16 inch, 1 30 014402-001 inch. VPU Accessories: 1 Long VPU 013500-001 Strap, 1 Short VPU Strap, 1 Belt Holster...

  • Page 34: When The Device Should Not Be Used (Contraindications)

    • Have an eye disease or condition that could prevent the Argus 2s system from working properly. • Have an eye structure or condition that could make it difficult to successfully implant the Argus II Implant or recover following surgery.

  • Page 35: General Warnings And Precautions

    Argus II Implant. • Do not enter a room housing a magnetic resonance imaging (MRI) System that has a rating other than 1.5 or 3.0 Tesla, even if you are not using Argus 2s Chapter 2: Descriptive Information Page 28...
  • Page 36 Unsafe. Severe harm to people in the MR system room or damage to this equipment may result. • Do not use the Argus 2s system within 3 feet (0.9 meters) of medical monitoring, diagnostic or life support equipment. Using the Argus 2s system near this equipment may cause the equipment to function improperly.
  • Page 37 General Precautions • Stop using the Argus 2s system if you experience any uncomfortable feeling such as pain. Should this occur, immediately take off the Argus 2s Glasses or turn off the Argus VPU. Then contact your doctor programming clinician to report the problem.
  • Page 38 Avoid rubbing your implanted eye. This may dislodge the implant or cause eye irritation. • Do not rely on the Argus 2s system as your only aid when walking. The Argus 2s system will not provide you with enough vision to walk safely without any other aids.
  • Page 39 3. Tell the equipment operator or your doctor what happened. If you continue to experience interference, or if you think that your Argus 2s system is not working as well as it did before you encountered the interference, please contact your doctor.
  • Page 40 The following sections provide additional information regarding potential sources of electromagnetic interference: • Precautions Regarding Other Medical Procedures, page 34 • Possible Interference from Other Electronic Devices, page 36 • Air Travel, General Travel and International Use, page 39 The potential effects of EMI from devices or procedures are summarized in Appendix A, page 113.
  • Page 41 Your doctor should contact Second Sight at 1-818-833-5060 for more information. • Do not wear or use your Argus 2s Glasses or VPU when undergoing a medical test or procedure, unless you are having a vision test. Using or wearing the Argus 2s Glasses or VPU during these procedures could cause you harm.
  • Page 42 • Avoid the use of bipolar electrosurgical equipment in your implanted eye. This equipment may damage the Argus II Implant. • You may undergo computed tomography scan (CT Scans) or Diagnostic Ultrasound. However, if you need a scan or 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.
  • Page 43 Radiofrequency identification (RFID) systems. These systems may temporarily interrupt Argus 2s stimulation if you are using your Argus 2s system within 3.5 yards (3.2 meters) of them. Your Argus 2s system will start operating normally when you move away from these devices.
  • Page 44 • The Argus 2s 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 2s system before implant surgery to make sure both the hearing aid and Argus 2s system will function properly.
  • Page 45 Wireless Router 12 inches Devices with antennae may be marked with the following symbol: Normal operation will resume when you move away from these items. Chapter 2: Descriptive Information Page 38...
  • Page 46 Air Travel, General Travel and International Use CAUTION: Do not turn on the VPU or use the Argus 2s system on an airplane. The Argus 2s system operates using wireless technologies that could interfere with the safe operation of an airplane.

  • Page 47: Your Patient Identification Card

    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.
  • Page 48 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.
  • Page 49 Figure 7: Patient ID Card 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...
  • Page 50 Second Sight Medical Products, Inc. Device Registration 13170 Telfair Ave Sylmar, CA 91342, USA In addition to your Patient Identification Card, you may want to wear a Medical Alert Bracelet. If you choose to purchase one of these bracelets, you should include the following...

  • Page 51: Risks And Probable Benefits

    Chapter 5. Surgical Risks To receive the Argus 2s system, you will need to have surgery. During this surgery, your doctor will implant the Argus II Implant in and around the eye. You will need to have general anesthesia.
  • Page 52 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 System Once you have the implant, there are risks associated with having an implant in your eye. There are also the risks of having electricity stimulate the nerve cells in your eye.
  • Page 53 (the innermost layer) may need surgery or treatment with a laser to fix. In some cases, these events may affect how well the Argus 2s system works. • Large-scale growth of cells in the eye that pull on the...
  • Page 54 Note that this pain may occur while you are using the Argus 2s 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.
  • Page 55 The Argus 2s 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 2s system as your only aid when walking. Chapter 2: Descriptive Information Page 48...
  • Page 56 The following events may occur occasionally and typically resolve on their own or with medication: • Infection outside the eye • Redness and irritation in or around the eye • Irritation caused by the sutures • Separation of the choroid from the sclera •...
  • Page 57 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 2s system with your other aides (such as a dog or a cane) and techniques.
  • Page 58 How Much Field of View Can the Argus 2s system Give Me? The Argus 2s system 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 of about 3.5 inches by 6.5 inches (9 by 16.5 centimeters) at arm's length, or slightly...
  • Page 59 (32.3 square centimeters) in size. What Are the Probable Benefits of the Argus 2s system? The Argus 2s system may help you do tasks visually, rather than by touch. During the clinical trial, some subjects were able to locate lights and windows, follow lines in a crosswalk, or avoid running into things as they walked.
  • Page 60 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 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.

  • Page 61: Chapter 3: What To Expect Before, During And After Surgery

    Chapter 3: What to Expect Before, During and After Surgery Before Surgery Two days before 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.
  • Page 62 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 gel-like fluid inside your eye. Your doctor will replace the fluid with a saline solution.

  • Page 63: After Surgery

    After Surgery After you have the Argus II Implant, you will need to return several times to the clinic for clinical follow-up, device programming, and 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.
  • Page 64 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.
  • Page 65 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”) 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.
  • Page 66 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.
  • Page 67 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.
  • Page 68 When to Call Your Doctor Call your doctor if any of the following situations occur: • You are experiencing any 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.

  • Page 69: Chapter 4:Using Your Device

    Chapter 4:Using Your Device Setup Instructions To set up the equipment for use you will need to: 1. Charge the battery 2. Insert the battery into the VPU 3. Connect the glasses to the VPU 4. Put on the VPU 5.
  • Page 70 Insert the battery into the VPU. Open the battery door by pushing down while sliding it to the outside of the VPU. One end of the battery is completely round, the other has a flat side. Hold the end of the battery with the flat side.
  • Page 71 Figure 10: Insert the Battery 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.
  • Page 72 Connect the glasses and the VPU. The glasses and VPU need to be connected by the glasses cable in order for the system to work. Your Argus 2s system comes with two Argus 2s Glasses Cables of different lengths. You can change the cable depending upon how you would like to wear the VPU.
  • Page 73 Figure 11: Connect the Glasses Cable e The other end of the cable has a trapezoid shape. This plugs into the top of the VPU. There is a raised horizontal line on the front of this connector. That line should face the front of the VPU when inserting the connector into the VPU.

  • Page 74: Operating Instructions

    CAUTION: If you experience any discomfort during the use of the device, please contact your clinician or Second Sight promptly. CAUTION: glasses become uncomfortably warm discontinue use until the they cool down to their usual operating temperature.
  • Page 75 If the problem continues, contact Second Sight. Since the camera on the glasses may not work well in dimly lit environments, make sure that you have enough light when you are using the system. If you are inside, you should always make sure the lights are on in the room To turn on the VPU.
  • Page 76 To mute audible tones and vibrations. To mute the audible tones, press the mute button on the top left of the VPU, vibrations will still occur in this mode. To disable both tones and vibration, press and hold the mute button. The Low Battery and VPU Error tones will still play even when the VPU tones have been muted.
  • Page 77 The VPU uses tones to provide you with information about the status of the VPU and glasses and to tell you about problems with the Argus 2s system. Table 7 summarizes the meaning of these indicators. Table 7: Audible Tones and LED’s...
  • Page 78 Sound Lights Meaning followed be solid before the approximately musical tone, after the 20-seconds tone it will blink quickly later by a during start-up. It will musical tone blink slowly during system use. Musical tone The Power button is not The VPU is turning off.

  • Page 79: Checking The Function Of The Device

    Second Sight. Checking the Function of the Device It is important that you periodically check the Argus 2s system for normal wear and tear. If you notice any exposed wires on the glasses or loose or broken parts on the glasses or VPU, contact your clinician.

  • Page 80: Cleaning

    This damage equipment or its labels. Maintenance The Argus 2s system 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...

  • Page 81: Handling And Storage

    The electromagnetic field generated by the Argus 2s system may damage or erase the information that is stored on magnetically-sensitive storage devices. Metal objects. Do not allow any metal objects within 6 inches (15.2 cm) of the glasses antenna while the VPU is...
  • Page 82 VPU, remove the battery and allow the VPU to dry completely before using the system again. Transport and Storage of the Argus 2s VPU and Glasses. Transport and store the packaged Argus 2s VPU and glasses at temperatures between 32F (0°C) and 113F (45°C).

  • Page 83: Expected Failure Time And Its Effect On You

    Traveling with the external devices. Store the VPU, glasses, and batteries in the travel case provided by Second Sight. The travel case is designed to protect the equipment. Do not place anything on top of the glasses or VPU. Expected Failure Time and Its Effect on You The Argus II Implant is designed to operate for at least five years.
  • Page 84 Argus 2s system. During transport, storage and handling for disposal, the following safety precautions should be considered: WARNING During transport, storage handling for disposal, the following safety precautions should considered: dispose batteries or battery charger in a fire as this may cause an explosion and/or the release of toxic fumes.
  • Page 85 charged force-discharged, leakage of flammable gas may be caused. This could possibly result in fire, rupture or explosion. Do not mix used batteries with other materials. If the batteries are short-circuited, abnormally charged or force-discharged the heat generated 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 VPU or glasses.
  • Page 86 If you have the Argus II Implant explanted 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, page 105.)

  • Page 87: Chapter 5: Troubleshooting

    Chapter 7, page 105 of this manual to contact Second Sight. CAUTION: If you encounter a clinical or physical problem (such as eye pain or discomfort) related to the Argus 2s system, please contact your doctor programming clinician immediately.
  • Page 88 Symptom Corrective Action pressing the correct The VPU does button. The power not start button is the indented (continued) circular-shaped button on the top of the VPU (see Figure 4). 3. Check that you are pressing the power button for at least two seconds.
  • Page 89 3. 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. The VPU is 1. Check that the VPU is on, but I don’t...
  • Page 90 Symptom Corrective Action no sound is heard, the VPU is off. Press the power button to turn The VPU is the VPU on. on, but I don’t 2. Check that the VPU is see anything not making any audible (continued) tones.
  • Page 91 Symptom Corrective Action on the glasses. 6. Check that the lens on the camera is clean. Refer to “Cleaning” in Chapter 3. 7. Check that there is enough lighting. 8. Try inverting the image (from black-to-white or white-to-black) using the invert button on the top of the VPU.
  • Page 92 Symptom Corrective Action The VPU is 1. Check that nothing is on, but the blocking the camera image seems on the glasses. distorted 2. Check that the lens on the camera is clean. Refer to Chapter 3, “Cleaning.” 3. Try using one of the other program settings to see if there is an improvement.
  • Page 93 If the problem continues or the antenna is getting unusually warm, contact Second Sight using the contact information provided in Chapter 7, page105. The mute button may have Mute button been pressed...
  • Page 94 “on”. as intended, but I do not hear any audible tones If the problem persists, contact your programming clinician or use the information in Chapter 7, page 105 to contact Second Sight. Chapter 5: Troubleshooting Page 87...

  • Page 95: Chapter 6: Additional Information

    Clinical Studies Introduction Argus 2s Changes and Clinical Evaluation The Argus 2s system has overall the same functionality as the approved Argus II system with some upgrades to the glasses and VPU. However, the implant part of the system is identical to the approved Argus II implant.
  • Page 96 Users also found the VPU comfortable to use and wear. Argus II Clinical Studies 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.
  • Page 97 During study, subjects experienced least side effect complication related to the Argus II System or the surgery to implant the device. Two subjects had no side effects. Of the 28 subjects, 17 had non-serious side effects that either were treated with medication or did not require any treatment at all.
  • Page 98 • 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 • 1 subject had a thinning and clouding of the cornea caused by an infection in the cornea •...
  • Page 99 o 11 subjects had a thin layer of tissue grow on the retina o 10 subjects had redness of the conjunctiva o 9 subjects had 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...
  • Page 100 o The following side effects occurred in 1 subject each: 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 o Build-up of fluid in the choroid o Scar tissue inside the eye o Scar tissue around the tack used to...
  • Page 101 o Partial separation of the retina from choroid pulling 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...
  • Page 102 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-a- time at the lower home use level was 13.4. During the clinical trial, 13 subjects had fewer than 20 electrodes that produced perception of light when stimulating one electrode at a time.
  • Page 103 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.
  • Page 104 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.

  • Page 105: Information About Retinitis Pigmentosa

    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.
  • Page 106 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 99...

  • Page 107: Warranty

    Prosthesis (Implant) This 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.
  • Page 108 External Devices include the video processing unit (VPU), glasses, battery, battery charger base and battery charger AC adaptor. We warrant that the Argus 2s VPU and Glasses will be free from defects in workmanship and materials for 1 year from the date of first VPU programming (or date of purchase if bought separately).
  • Page 109 WE EXPRESSLY DISCLAIM ALL IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED 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.
  • Page 110 anyone else. This warranty excludes defects caused by attachment of an External Device 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.
  • Page 111 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, page 105. Chapter 7: Warranty Page 104...

  • Page 112: Chapter 7: Contact Information

    Chapter 7: Contact Information Second Sight Medical Products welcomes your comments about the Argus 2s Retinal Prosthesis System or your suggestions to improve the product. Please feel free to contact us for technical assistance, replacement parts, your suggestions. Second Sight Medical Products, Inc.
  • Page 113 Write important telephone numbers here Resource Telephone number: Clinic Physician Device disposal contact: Chapter 7: Contact Information Page 106...

  • Page 114: Chapter 8: Symbols And Regulatory Classifications

    Chapter 8: Symbols and Regulatory Classifications Symbols The following symbols appear on components of the Argus 2s system. The symbols and their meanings are described below. Table 10: Symbols Symbol Meaning Catalog number Serial number Lot number Date of manufacture...
  • Page 115 Symbol Meaning Keep Dry Non-ionizing radiation (Radio frequency radiation) Manufactured by Type BF Applied Part MR Conditional MR Unsafe Chapter 8: Symbols and Regulatory Classifications Page 108...

  • Page 116: Regulatory Classifications

    Regulatory Classifications The Argus 2s system meets the requirements of several international standards and directives. The table below indicates how the Argus 2s system is classified according to each of these standards and directives. For detailed information regarding electromagnetic environments, please Appendix A, page 113.
  • Page 117 Standards / Regulatory Directives Classifications IEC 60601-1-2 Classification: Classifications (CISPR 11 Group 1 Equipment Electromagnetic Equipment in which Emissions) 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...
  • Page 118 Standards / Regulatory Directives Classifications IEC 60601-1-2 Classification: (Electromagnetic Immunity) The Argus 2s system may experience interference from ESD, power frequency magnetic fields, and conducted and radiated IEC 60601-1-11 Classification: P22, Protected from touch by fingers and objects greater than 12 millimeter.
  • Page 119 Standards / Regulatory Directives Classifications R&TTE Directive Classification: Product Type 1 - Inductive loop antenna 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.

  • Page 120: Appendix A: Potential Effects Of Electromagnetic Interference (Emi)

    Appendix A: Potential Effects of Electromagnetic Interference (EMI) Information for Users (FCC Rules) FCC waiver DA 11-1951, has been granted to Second Sight Medical Product Inc. This allows the Argus II system to operate with emissions at the fundamental frequency (3.156 MHz) not to exceed 119 μV/m at 30 meters and has been used to pass the...
  • Page 121 • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected • 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.
  • Page 122 Potential Effect: Device or procedure Commercial electrical equipment (for example, arc ✓ welders Page 39 induction furnaces, resistance welders, etc.) Communicatio n equipment (such as microwave transmitters, ✓ Page 39 linear power amplifiers and high-power amateur transmitters) ✓ Defibrillator Page 35 ✓...
  • Page 123 Potential Effect: Device or procedure Electronic article surveillance ✓ Page 36 (EAS) systems and EAS tag deactivators ✓ Fragmatome Page 34 ✓ Hearing aids Page 37 High output ✓ ✓ Page 39 ultrasound High voltage lines, power ✓ Page 39 lines or generators Home...
  • Page 124 Page 38 If the medical procedure is being performed to evaluate the area where the Argus 2s Implant is located, the implant may block or blur the image making it unreadable in this area. Appendix A: Potential Effects of Electromagnetic...

  • Page 125: Index

    Index airplane, 40 decrease in light perception, airport, 37, 41 Alerts Audible Tones, 70 defibrillator, 36 allergic reaction, 48 detector Amber light is blinking, 87 metal, 37 anesthesia, 28, 54 theft, 37, 61 antibiotic, 28 Device Disposal, 77 battery, 18 device programming, 56, 57 battery life, 71 diathermy, 29...
  • Page 126 disconnecting, 70 pain, 30, 31, 44, 45, 47, 55, disposal, 78 61, 80, 92 exposure to liquid, 75 patient identification (ID) handling, 75 card, 41 handling and storage, 74 phacoemulsification, 35 maintenance, 73 power generators, 40 materials, 21 Precautions, 29, 31 storage, 75 pregnancy and nursing, 32 unapproved componenets,...
  • Page 127 Travel, 40 maintenance, 73 travel case, 23 shuts off suddenly, 82 troubleshooting, 80 storage, 75 ultrasound, 29, 36 turning off, 69 visual field, 51 turning on, 68 visual rehabilitation, 56, 59 Unapproved components, Volume Slider, 16 VPU, 4, 12, 14, 15, 26 usage temperature range, audible RF link alarm, 69 VPU is on, but I don’t see...
  • Page 129 Second Sight Medical Products, Inc. 13170 Telfair Ave Sylmar, CA 91342, United States Phone: +1 818 833 5060 Fax: +1 818 833 5067 E-mail: service@secondsight.com Visit us at www.secondsight.com January 2021...

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