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Second Sight Argus II Patient Manual

Retinal prosthesis system
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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

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  • Page 1 ® Argus 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.
  • Page 3 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.

  • Page 5: Table Of Contents

    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 ......
  • Page 6 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...

  • Page 7: Chapter 1: Glossary

    Chapter 1: Glossary Term Definition Choroid{ XE A thin layer of cells "choroid" } between the retina and the sclera that contains pigments and blood vessels that bring oxygen and nutrients to the retina (See Figure 1) Communication A device that is Adapter (CA) connected to the Video Processing Unit (VPU)
  • Page 8 Term Definition Cornea{ XE The clear layer of tissue, "cornea" } 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...
  • Page 9 "electromagneti electronic equipment. c interference This field of energy may (EMI)" } (EMI) be strong enough to interfere with the normal operation of your Argus II System. Electrostatic A momentary unwanted Discharge flow of electrical current (ESD{ XE that can cause damage "electrostatic...
  • Page 10 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.
  • Page 11 (See Figure 1) Therapy Treatment of disease or disorders VPU{ XE "VPU" The part of the Argus II } (Video System that processes Processing the information that is Unit) sent to and from the...
  • Page 12 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...

  • Page 13: Chapter 2: Descriptive Information

    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: •...

  • Page 14: Device Description

    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.
  • Page 15 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 non- approved cables or batteries may also cause the Argus II System to interfere with other electronic equipment.
  • Page 16 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.
  • Page 17 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.
  • Page 18 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 (inside the eye) (outside the eye) Chapter 2: Descriptive Information Page 12...
  • Page 19 External Equipment Figure 3 shows the VPU, glasses, and battery{ external equipment " " Figure 3: External Equipment Glasses Camera Glasses Coil 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 suit...
  • Page 20 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.
  • Page 21 Figure 4: VPU{ XE "VPU" } Indicator lights Glasses Top of Receptacle Power Button Inverse Setting Program Button Setting 1 Audible RF Program Link Alarm Setting 2 Button Program Setting 3 Right Side of VPU Battery in Receptacle Left Side of VPU Battery Latch...
  • Page 22 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 The power button is a round- Button shaped button located on the right side of the VPU.
  • Page 23 Component Description Inverse The inverse button is the Setting square-shaped button located Button on the right-hand side of the VPU. You use this button to invert{ XE "VPU:invers setting button" } the image from black- to-white and white-to-black. Each time you press it, the VPU inverts the image.
  • Page 24 Component Description Battery The battery latch is located on Latch 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 Three indicator lights are Lights located on the front of the VPU between the program setting...
  • Page 25 Second Sight. Battery Recharge the batteries using Charger 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.
  • Page 26 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...
  • Page 27 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.
  • Page 28 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 Use the travel case to safely store Case{ XE and transport the VPU, glasses "travel case"...
  • Page 29 } 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 3.156 Megahertz (MHz) (to the implant) Frequency 473 –...
  • Page 30 “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.
  • Page 31 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”...
  • Page 32 Argus II Patient Catalog The following items are included in your Argus II Retinal Prosthesis Patient Catalog{ catalog XE " numbers " Table 5: Patient Catalog Description Catalog / Product Number Argus II Video Processing 013003 Unit{ XE "VPU" }...
  • Page 33 Description Catalog / Product Number Argus II Travel Case{ XE 012930 "travel case" } Argus II VPU Pouch{ XE "VPU 013931 pouch" } Chapter 2: Descriptive Information Page 27...

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

    When the Device Should Not be Used (Contraindications) You should not have the Argus II Retinal Prosthesis{ contraindications } implanted if XE " " you: • Have an eye disease or condition that could prevent the Argus II System from working properly.

  • Page 35: General Warnings And Precautions

    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.
  • Page 36 } 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.
  • Page 37 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.
  • Page 38 }. Should this occur, XE " " 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...
  • Page 39 • 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...
  • Page 40 “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.
  • Page 41 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.
  • Page 42 Additional information about electromagnetic compatibility is included in Appendix B. Chapter 2: Descriptive Information Page 36...
  • Page 43 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.
  • Page 44 Ultrasound. However, if you need a scan or ultrasound{ ultrasound } in the area XE " " 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{ defibrillator }s or XE "...
  • Page 45 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.
  • Page 46 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...
  • Page 47 Argus II System will function properly. • Avoid home appliances, such microwaves,{ microwaves } and some XE " " devices with antennae, such as cell phones, when using the Argus II System. Home appliances devices with antennae may temporarily interrupt Argus II stimulation.
  • Page 48 Normal operation will resume when you move away from these items. Do not turn on the Argus II System on an • airplane{ airplane }. The Argus II XE " " System operates using wireless technology that could interfere with the safe operation of an airplane.
  • Page 49 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.

  • Page 50: Your Patient Identification Card

    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{ airport }. You XE " " 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.
  • Page 51 Figure 7: Patient ID Card Chapter 2: Descriptive Information Page 45...
  • Page 52 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.

  • Page 53: Risks And Probable Benefits

    For information about the risks experienced by patients in the clinical trial, please refer to Chapter Surgical Risks To receive the Argus II System, you will need to have surgery{ risk: }. During this XE "...
  • Page 54 There are also the risks{ risk: } of XE " Argus II specific" having electricity stimulate the nerve cells in your eye. The following are risks specific to the Argus II Implant: • The implant or the sutures{ suture XE " "...
  • Page 55 problem, your doctor may need to remove the implant from your eye. • One or more of the wound{ wound XE " " 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.
  • Page 56 } to fix. In XE " " some cases, these events may affect how well the Argus II System works. • Large-scale growth of cells{ growth of XE " cells } in the eye that pull on the retina or "...
  • Page 57 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.
  • Page 58 the eyelid{ drooping of the eyelid } may XE " " 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{ future XE "...
  • Page 59 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.
  • Page 60 • Dryness of the cornea • Dry eye{ dry eye } or watering eye{ XE " " watering eye " " • Cyst{ cyst }s on the eye XE " " Nausea{ nausea } or dizziness{ • XE " " dizziness "...
  • Page 61 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.
  • Page 62 The Argus II System{ field of view } delivers XE " " 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...
  • Page 63 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{ clinical trial }, three subjects were asked XE "...
  • Page 64 What Are the Probable Benefits of the Argus II System? The Argus II System{ probable benefit } may XE " " help you do tasks visually, rather than by touch. During the clinical trial{ clinical trial }, some XE "...

  • Page 65: 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{ XE "surgery" }, you will start taking antibiotics. The Day of Surgery Below is general information about how the Argus II System is implanted. 1.
  • Page 66 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.

  • Page 67: After Surgery

    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{ "clinical follow-up"...
  • Page 68 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.
  • Page 69 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.
  • Page 70 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.
  • Page 71 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...
  • Page 72 Second Sight 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.
  • Page 73 " 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.

  • Page 74: Chapter 4: Using Your Device

    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.
  • Page 75 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.
  • Page 76 Once the VPU is in the pouch, you can wear the VPU. 6. Connecting glasses{ "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...
  • Page 77 7. Disconnecting glasses{ "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.

  • Page 78: Operating Instructions

    VPU. If you use another patient’s VPU, could have uncomfortable stimulation. CAUTION: If you experience any discomfort during the use of the device, please contact your clinician or Second Sight promptly. Chapter 4: Using Your Device Page 72...
  • Page 79 To use the VPU and glasses, follow the instructions below. 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...
  • Page 80 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"...
  • Page 81 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.
  • Page 82 Figure 9: VPU{ XE "VPU:indicator lights" } Indicator Light Colors Green Amber Orange Table 7: Indicator Light Colors Indicator Light Meaning Light flashing Color Green Fast The VPU is going periodic through its start-up blinking diagnostic testing. Chapter 4: Using Your Device Page 76...
  • Page 83 Indicator Light Meaning Light flashing Color Green Slow The VPU is operating periodic normally. blinking (1 per second) 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...
  • Page 84 Sound Meaning alarms" } has been pressed (for example, a Program Setting or Inverse Setting Button). One beep followed by The VPU is turning off. a pause, followed by two short beeps Four short beeps The VPU is starting up. Three short beeps An error has occurred and the VPU is about to shut down...

  • Page 85: Checking The Function Of The Device

    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{ broken parts } on the glasses XE "...

  • Page 86: Cleaning

    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{ battery: " cleaning" contacts, follow the instructions in the battery package.

  • Page 87: Maintenance

    }. Do " " 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. electromagnetic field generated by the Argus II System may damage...
  • Page 88 VPU: only " Unapproved components" components and accessories supplied by Second Sight with the Argus II System. If you unapproved components, damage the equipment, resulting in loss of stimulation and/or injury. unapproved components, you will also void the manufacturer’s warranty.
  • Page 89 } with the external XE " " 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 Chapter 4: Using Your Device...

  • Page 90: Expected Failure Time And Mode And Its Effect On You

    " 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.

  • Page 91: How To Safely Dispose Of The Device

    How to Safely Dispose of the Device Follow the safety precautions below when you are transporting, storing disposing components of the Argus II System. During transport, storage and handling for disposal, the following safety precautions should be considered: WARNING dispose batteries{ "battery:disposal,...
  • Page 92 flammable or harmful. Store used batteries for disposal in a clean dry environment out of direct sunlight and away from extreme heat. Dirt and wetness may cause short- circuits and heat. Heat may cause leakage of flammable gas which may result in fire, rupture or WARNING explosion.
  • Page 93 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{ implant XE " disposal } explanted{...
  • Page 94 Dispose of the shipping carton{ packaging XE " material disposal } and packaging materials for " the Argus II System components according to local regulations. Chapter 4: Using Your Device Page 88...

  • Page 95: Chapter 5: Troubleshooting

    Chapter 7 of this manual to contact Second Sight. CAUTION: If you encounter a clinical or physical problem (such as eye pain{ XE "pain"...
  • Page 96 If the problem VPU: persists, contact either XE " produces an audible warning" your clinician or your } (three short Second Sight beeps) and representative. shuts off suddenly Chapter 5: Troubleshooting Page 90...
  • Page 97 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...
  • Page 98 Symptom Cause and/or Corrective Action The VPU is Confirm that the VPU on, but I don’t is on by pressing any see anything{ button on the VPU XE "VPU:VPU other than the power is on, but I button. If a beep is don’t see heard, then the VPU is anything"...
  • Page 99 Symptom Cause and/or Corrective Action between the external coil and the implant is reliable. 4. Ensure that nothing is The VPU is blocking the camera on, but I don’t on the glasses. If there see anything is something blocking (continued) the camera, try to remove the obstruction.
  • Page 100 Symptom Cause and/or Corrective Action The VPU is 1. Ensure that nothing is on, but the blocking the camera image seems on the glasses. distorted{ XE 2. Ensure that the lens on "VPU:is on, the camera is clean. but the image Refer to Chapter 4, seems “Cleaning.”...
  • Page 101 Symptom Cause and/or Corrective Action Switch between the normal/invert settings by pressing the square-shaped invert button. The VPU is 5. Ensure that the on, but my intended Program perception is Setting is being used dimmer than to provide the optimum usual perception by (continued)
  • Page 102 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...
  • Page 103 Table 10: Indicator Lights Symptom Cause and/or Corrective Action The green 1. Change to a fully light is not charged battery{ XE blinking "VPU:indicator lights, troubleshooting" }. 2. Turn off the VPU and turn it back on again to see if the problem is fixed.
  • Page 104 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...
  • Page 105 Symptom Cause and/or Corrective Action shutdown) information provided in Chapter 7. The VPU 1. Turn off the VPU. emits the 2. Install a fully-charged following battery onto the VPU. periodic Refer to instructions beeping provided in Chapter 4, pattern: “Install the battery.” 3 short beeps 3.
  • Page 106 Symptom Cause and/or Corrective Action the glasses to the VPU.” The VPU 1. Allow the VPU to finish emits fast the start-up test and periodic ensure that the green beeps about 2 light is blinking per second approximately 1 blink (loss of RF per second.
  • Page 107 Symptom Cause and/or Corrective Action beeping related to the temporary loss of The VPU communication with the emits fast implant can be turned periodic off by pressing the star- beeps about 2 shaped switch on the per second right side of the VPU. (loss of RF link, continued)
  • Page 108 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...

  • Page 109: Chapter 6: Additional Information

    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.
  • Page 110 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).
  • Page 111 • 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.
  • Page 112 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...
  • Page 113 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 hold the implant to the retina...
  • Page 114 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 115 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{ XE "clinical trial"...
  • Page 116 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.
  • Page 117 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...
  • Page 118 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.

  • Page 119: Information About Retinitis Pigmentosa

    Information about Retinitis Pigmentosa Retinitis pigmentosa{ retinitis pigmentosa XE " " (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.

  • Page 120: Warranty

    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 121 (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).
  • Page 122 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 123 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...

  • Page 124: Chapter 7: User Assistance Information

    Chapter User Assistance Information 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, your suggestions. Second Sight Medical Products, Inc.
  • Page 125 Write important telephone numbers here Resource Telephone number: Clinic Physician Device disposal contact: Chapter 7: User Assistance Page 119...

  • Page 126: Chapter 8: Symbols And Regulatory Classifications

    Symbols Regulatory Classifications Symbols The following symbols{ symbols } appear on XE " " 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...
  • Page 127 Symbol Meaning Manufactured by Type B Applied Part MR Conditional MR Unsafe Chapter 8: Symbols and Regulatory Classifications Page 121...

  • Page 128: Regulatory Classifications

    " 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 Appendix B.
  • Page 129 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 130 Standards / Regulatory Directives Classifications IEC 60601-1-2 Classification: (Electromagnetic Immunity) The Argus II System may experience interference from ESD{ electrostatic XE " discharge (ESD) " power frequency magnetic fields, and conducted and radiated Chapter 8: Symbols and Regulatory Classifications Page 124...
  • Page 131 Standards / Regulatory Directives Classifications R&TTE Directive 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.

  • Page 132: Index

    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 ·...
  • Page 133 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 ·...
  • Page 134 · 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...
  • Page 135 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 ·...
  • Page 136 · 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 ·...
  • Page 137 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 ·...

  • Page 138: Appendix A: Potential Effects Of Electromagnetic Interference (Emi)

    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.
  • Page 139 • 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...
  • Page 140 Potential Effect: Damage Temporary Additional Device or procedure Patient to the Interruption Image Information injury Argus II Artifact System Stimulation ✓ Computed tomography (CT) Scan Page 38 Commercial electrical equipment (for example, arc welders ✓ Page 42 induction furnaces, resistance welders, etc.)
  • Page 141 Potential Effect: Damage Temporary Additional Device or procedure Patient to the Interruption Image Information injury Argus II Artifact System Stimulation ✓ ✓ Diathermy Page 29 ✓ Electric steel furnaces Page 42 ✓ ✓ Electroconvulsive therapy (ECT) Page 29 Electronic article surveillance ✓...
  • Page 142 Potential Effect: Damage Temporary Additional Device or procedure Patient to the Interruption Image Information injury Argus II Artifact System Stimulation High voltage lines, power lines or ✓ Page 42 generators ✓ Home appliances Page 41 ✓ Large magnetized speakers Page 42 ✓...
  • Page 143 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 144: Appendix B: Electromagnetic Environments

    } and manufacturer’s declaration – electromagnetic 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 –...
  • Page 145 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.
  • Page 146 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.
  • Page 147 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.
  • Page 148 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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