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Chapter 8: Symbols and Regulatory Classifications

Page 110

Standards /

Directives

Regulatory

Classifications

IEC 60601-1-2
Classifications
(CISPR 11
Electromagnetic
Emissions)

Classification:

Group 1 Equipment
Equipment in which
there is intentionally
generated and/or used
conductively coupled
radio frequency
energy, which is
necessary for the
internal functioning of
the equipment itself.
Therefore, its RF
emissions are very low
and are not likely to
cause any interference
in nearby electronic
equipment.

Class B Equipment
Equipment suitable for
use in all
establishments
including your home.

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Summary of Contents for Argus 2s

Page 1: ...r 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 3: ...elfair Ave Sylmar CA 91342 USA 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 ...

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Page 5: ...o Expect Before During and After Surgery 54 Before Surgery 54 The Day of Surgery 54 After Surgery 56 Chapter 4 Using Your Device 62 Setup Instructions 62 Operating Instructions 67 Checking the Function of the Device 72 Cleaning 73 Maintenance 73 Handling and Storage 74 Expected Failure Time and Its Effect on You 76 How to Safely Dispose of the Device 76 Chapter 5 Troubleshooting 80 Chapter 6 Addit...

Page 6: ...pter 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 ...

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Page 8: ...od 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 See Figure 1 Cornea The clear layer of tissue shaped like a dome which 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 ...

Page 9: ...imulate the retina Electrical Stimulation A technique that uses electrical currents to activate nerve fibers Electromagnetic Interference EMI A field of energy electrical magnetic or both created by electronic equipment This field of energy may be strong enough to disrupt the normal operation of your Argus 2s System Electrostatic Discharge ESD A brief unwanted flow of electrical current that can c...

Page 10: ...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 The center of the iris is an opening called the pupil The iris controls the size of the pupil when it reacts to the amount of light that is present See Figure 1 Radio Frequency RF Any electromagnetic frequency within the range used for wireless communication ...

Page 11: ...e outer part of the eye made of tough tissue that allows the eye to keep its shape and helps to protect the delicate inner parts of the eye See Figure 1 Therapy Treatment of disease or disorders VPU Video Processing Unit The part of the Argus 2s System that you carry It processes the information that is sent to and from the implant inside your eye You can choose different settings on the VPU ...

Page 12: ...Chapter 1 Glossary Page 5 Figure 1 Parts of the Human Eye Image courtesy of the National Eye Institute National Institutes of Health Sclera Choroid ...

Page 13: ... not have any remaining light perception your doctor will test your eye to make sure it will respond to electrical stimulation You need to have been able to see objects shapes and lines in the past In the eye that will be implanted you either need to have an artificial lens or no lens at all If the eye that will be implanted still has a natural lens your doctor will remove this lens during the imp...

Page 14: ...2s Glasses Accessories Lenses Clear or Dark Glasses Cable Rechargeable Battery for use in VPU Battery Charger Belt Holster VPU Straps Travel Case WARNING Do not use any equipment with your Argus 2s System other than that supplied by Second Sight If you use cables or batteries not supplied by Second Sight your Argus 2s system may be more likely to experience interference from other electronic devic...

Page 15: ...he glasses The antenna on the glasses sends the signals wirelessly to the implant The implant then sends out small pulses of electricity to your retina These pulses stimulate your retina Your retina sends the nerve signals along the optic nerve to your brain You perceive these pulses as patterns of light Over time you may learn how to interpret these visual patterns as objects and shapes Note The ...

Page 16: ...ckage to the electrode array This cable enters your eye through an incision made during surgery At the end of cable is the electrode array The electrode array is attached to the surface of your retina with a retinal tack The implant is not visible to other people The electrode array provides electrical stimulation to your retina It has 60 electrodes arranged in a rectangular grid Fifty five of the...

Page 17: ...nformation Page 10 Figure 2 Implant on a Right Eye looking at your eyeball Electronics Case outside the eye Implant Coil outside the eye Scleral Band outside the eye Electrode Array inside the eye Implant Antenna outside Eye ...

Page 18: ...he glasses the other end plugs into a port on the top of the VPU Each end of the cable has a different shape so that you can easily tell which end goes into each device Video Processing Unit VPU The VPU allows you to turn the system on and off choose different programs and control the volume of audible tones Using the buttons on the VPU you can choose different stimulation programs to suit your su...

Page 19: ... 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: ...mation Page 13 Figure 4 VPU Power Button Mute Button Volume Slider RF Link Loss Camera Loss Visual Indicator Network Connection Visual Indicator Program Selector Invert Selector Micro USB Port Loops for securing VPU Strap to VPU ...

Page 21: ... front of the VPU facing you the Power Button is located on the top right side of the VPU To turn on the VPU hold the button down for 2 3 seconds until you hear a beep The light on the button is green when the VPU is on Push the button again to turn off the VPU Mute Button The mute button is round and raised up It is on the top left side of the VPU The VPU has audible alerts as well as vibratory a...

Page 22: ...e VPU to no alerts push and hold the mute button Volume Slider The slider is located on front side of the VPU towards the top Slide it up and down to control the volume of all audible tones made by the VPU Program Selector The Program Selector is on front of the VPU in the middle It is below the Volume Slider You can move it into three different positions This allows you to choose from one of thre...

Page 23: ... Slide this door open to remove and replace the battery Indicators Lights There are two LED lights on the front of the VPU The amber light on the right indicates there is an issue with the VPU or system The blue light on the left is only used in the clinic during programming Glasses cable port The glasses cable port is on the top of the VPU between the Power button and the mute button This is wher...

Page 24: ...red with a rechargeable battery Only use the rechargeable batteries provided to you by Second Sight Battery Charger The battery charger is used 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 VPU Strap The VPU strap is a cloth strap that clips to the loops at top of the VPU The VPU can be worn eit...

Page 25: ...r right arm depending on which eye is implanted The antenna sends power to the implant and links wirelessly with it Figure 5 shows the glasses Table 3 provides a description of the parts of the glasses Figure 5 Glasses for the Right Eye The glasses cable comes with a clip attached This clip can be used to secure the cable to your clothing to help prevent it from being tangled as seen in Figure 6 D...

Page 26: ...Chapter 2 Descriptive Information Page 19 Figure 6 How to Use the Cable Clip a Press to open the cable holder b Push the cable into place and release c Clip on clothes ...

Page 27: ...ephthalate Stainless Steel Table 3 Glasses Components and Accessories Component Description Camera A small video camera is located in the center of the glasses frame above the nose bridge The camera sends video images to the VPU Glasses Antenna The glasses antenna contains the receiver and transmitter to link wirelessly with the implant The antenna is located on the same side of the glasses as the...

Page 28: ...ach end of the cable has a uniquely shaped connector so that it can only be attached in the correct way Cable Clip The cable clip can be used to attach the glasses cable to your clothes It comes attached to the cable The clip can be moved along the length of the cable To attach or remove the clip from the cable press both ends of the cable holder on the clip and slide the cable in or out as shown ...

Page 29: ...corner of the lens The clear lenses do not have a notch Travel Case The travel case is used to safely store and transport the 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 syste...

Page 30: ...antenna is approximately 1 inch 2 5 cm or closer to the implant Wireless Security The Argus II implant only operates if it is within a very short distance from the antenna on the glasses The Argus 2s system uses coded signals to make it harder for outside sources to accidentally or intentionally control the system The Argus 2s system does not store or send any information such as your name that wo...

Page 31: ... between the glasses and implant is lost a tone will sound and will continue to sound until the wireless link is restored You may lose the link in the presence of strong magnetic or radio fields Refer to the section entitled Possible Interference with Other Electronic Devices on page 36 and Appendix A page 113 for more information on interference related to the wireless system For Troubleshooting ...

Page 32: ...roduct Number Argus 2s Video Processing Unit 013300 001 Argus 2s Glasses only one Glasses Right Eye Medium Glasses Right Eye Large Glasses Left Eye Medium Glasses Left Eye Large 012200 001 012202 001 012201 001 012203 001 Glasses Accessories Replacement lenses cleaning cloth Contains wide nosepiece Clear Lenses Medium Clear Lenses Large Dark Lenses Medium 012603 001 012600 001 012601 001 ...

Page 33: ... Lenses Large 012602 001 VPU Battery Charger XTAR VC2 Plus Master 300300 209 VPU Battery Charger Power Supply 300300 210 Rechargeable VPU Batteries 4 013400 001 Glasses Cables 1 16 inch 1 30 inch 014402 001 VPU Accessories 1 Long VPU Strap 1 Short VPU Strap 1 Belt Holster 013500 001 ...

Page 34: ...e eye diseases or conditions that make it difficult for your doctor to see inside your eye For example if you have a cloudy cornea you may not be eligible for the Argus II Implant Are unable to undergo general anesthesia Are unable to take the recommended antibiotic and steroid medications that you need to take before and after implant surgery Have a metallic or active implantable device in your h...

Page 35: ... that could cause tissue damage or serious injury Diathermy may also cause permanent damage to the implant Do not undergo electroconvulsive therapy ECT ECT may damage your eye or your Argus II Implant Avoid lithotripsy or high output ultrasound These procedures may harm you or damage the implant If you need one of these procedures inform your doctor that you have this implant Your doctor should co...

Page 36: ...I in someone who has an Argus II Implant If you feel any pain during the MRI procedure tell the technician immediately Do not take the VPU or glasses into the MR system room The VPU and glasses are MR Unsafe Severe harm to people in the MR system room or damage to this equipment may result Do not use the Argus 2s system within 3 feet 0 9 meters of medical monitoring diagnostic or life support equi...

Page 37: ...he outside or inside of your eye If your doctor does not examine your eye when you have these symptoms you may develop an infection in your eye or have other serious complications The long term effects of electrical stimulation are unknown It may cause damage to the retina or optic nerve This sort of damage could lead to a decline in your normal remaining vision and or how well you see with the Ar...

Page 38: ...t all times Do not use the Argus 2s system during pregnancy or when nursing a baby Second Sight has not evaluated the use of the Argus 2s system by women who are pregnant or who are nursing a child Keep the device away from children pets or pests Electromagnetic Interference EMI Electromagnetic interference is a field of energy electrical magnetic or both created by equipment found in public envir...

Page 39: ...pected shutdown of the Argus 2s VPU EMI may cause your VPU to turn off suddenly Interruption of Stimulation EMI may cause a momentary interruption of stimulation If you suspect that electronic equipment is causing interference with your Argus 2s system you should do the following 1 Move away from the equipment or object thought to be causing the interference 2 If possible turn off the equipment or...

Page 40: ...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 Additional information about electromagnetic compatibility can be found in the Product Insert ...

Page 41: ...g or wearing the Argus 2s Glasses or VPU during these procedures could cause you harm It might also make it difficult for your doctor to understand the results of the test It could also damage the Argus 2s equipment Once the procedure is complete you should have your clinician test your Argus II Implant as soon as possible to make sure it is still working properly Damage to the implant may not be ...

Page 42: ...owever 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 Use of defibrillators or radiation therapy to the head may permanently damage the Argus II Implant However this should not stop you from receiving these treatments if necessary The effects of cobalt treatment or linear acceleratio...

Page 43: ...tient identification card to any attendant in the area who may be able to assist you in bypassing these devices Avoid Electronic Article Surveillance EAS systems EAS Tag Deactivators and 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 ope...

Page 44: ...em before implant surgery to make sure both the hearing aid and Argus 2s system will function properly Avoid home appliances such as microwaves and some devices with antennae such as cell phones when using the Argus 2s system Home appliances and devices with antennae may temporarily interrupt Argus 2s stimulation The table below lists the distance at which interruption of stimulation may occur wit...

Page 45: ...Chapter 2 Descriptive Information Page 38 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 ...

Page 46: ...rcial electrical equipment include arc welders induction furnaces and resistance welders Examples of communication equipment include microwave transmitters linear power amplifiers and high power amateur transmitters Air Travel General Travel and International Use CAUTION Do not turn on the VPU or use the Argus 2s system on an airplane The Argus 2s system operates using wireless technologies that c...

Page 47: ...ny complications during your trip For more information about travel contact the Transportation Security Administration TSA Website www tsa gov Email TSA ContactCenter dhs gov TSA General Phone Number 866 289 9673 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 You should call...

Page 48: ...ass a security system or in the event of a medical emergency Keep this card with you at all times To assist you in locating the card in your wallet the plastic covering for the card has two clipped corners on one side that you will be able to feel Refer to Figure 7 below for an example of a patient ID card This figure does not show the plastic covering with the clipped edges ...

Page 49: ...tient 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 address ...

Page 50: ...ar 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 information on it Active Implantable Device on right or left Eye See Patient ID Card in my wallet Doctor s Phone is XXX XXX XXXX ...

Page 51: ...n others are For information about the risks experienced by patients please refer to 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 Any surgery where you are under general anesthesia carries some risk The following are rare but poss...

Page 52: ...rough this tissue you may feel pain or discomfort This type of event can also lead to an infection in your eye Sometimes surgery is required to re cover the exposed parts to protect the other tissues of your eye and prevent more pain or infection If surgery cannot resolve the problem your doctor may need to remove the implant from your eye One or more of the wounds from the surgery could open This...

Page 53: ... 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 retina or growth of strands of tissue that pull on the inner lining of the eye may lead to separation of the layers of the eye If this happens to you you may need surgery to repair this problem The implant could move or the retinal tack hol...

Page 54: ...port it to your doctor 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 After implantation surgery you may notice some decrease in how much light you can see If this happens you should tell your doctor While this problem may go away ...

Page 55: ...he eye you might need surgery to either repair the tissue or remove the implant Your body may have an allergic reaction to the materials in the implant or glasses The following materials in the implant contact the tissues and fluids in your eye niobium titanium polyimide silicone rubber and platinum The materials in the glasses contact your skin These materials include the following carbon fiber p...

Page 56: ... thinning scraping or folding of the cornea Blood vessels deposits rough spots threads or mucus on the cornea Dryness of the cornea Dry eye or watering eye Cysts on the eye Nausea or dizziness The following events may occur occasionally and typically do not require any treatment Swelling of the retina or choroid Splitting of the layers of the retina Fold s in the retina Growth of blood vessels on ...

Page 57: ...em The Argus 2s system provides a form of vision that differs from the vision you used to have It does not restore normal vision It does not slow or reverse the progression of your disease In addition it will not replace your normal visual aids You will have to learn how to use the Argus 2s system with your other aides such as a dog or a cane and techniques When you are not using the Argus 2s syst...

Page 58: ...he number of electrodes that could do this was less than 60 If fewer than 20 of the 60 electrodes produce spots of light on their own your clinician may change the program on the VPU to turn on groups of electrodes at the same time A quad is a group of four electrodes next to each other on the array that stimulate at the same time It is possible that not all of your electrodes will be used and as ...

Page 59: ...46 square inches 297 square centimeters Most of the electrodes created spots of light that were less than five square inches 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 r...

Page 60: ...d 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: ...hesia 2 If you have a natural lens in your eye your doctor will remove it before inserting the implant If you have an intraocular lens in your eye your doctor will likely leave it in place 3 Your doctor will pull back the conjunctiva the thin tissue that covers the white part of your eye and the inside of your eyelid If your eye orbit is small your doctor may need to make a small cut at the outer ...

Page 62: ...tor will test the implant to make sure it is functioning properly 8 If the device is functioning properly your doctor will close all of the cuts in your eye Your doctor will then place a thin layer of tissue from a human donor over a small portion of the implant on the outside of your eye 9 Your doctor will close the conjunctiva with stitches that will dissolve over time 10 Your doctor will patch ...

Page 63: ...e instructions will include information about what medications you will need to take and when you will need to return for follow up visits Always follow these instructions If you experience any medical complications with your implant it is important to follow the instructions provided by your doctor for how to treat these complications It may take several weeks for you to recover from surgery Duri...

Page 64: ...ll need to be custom programmed or fitted for you Someone other than your doctor will likely perform this programming This person a programming clinician could be another doctor nurse or technician Initial Programming Sessions The purpose of the initial programming sessions is simple to find suitable stimulation levels so that the first visual program can be set on your VPU To do this you will nee...

Page 65: ...allow you to make better use of the device even if single electrode stimulation gives you little vision CAUTION Please note that the effect of using quad stimulation compared to single electrode stimulation was not specifically studied during the clinical trial Depending on your results this initial programming may take one visit lasting one to two hours or it may take a few such visits Preparing ...

Page 66: ...inician on a regular basis for a tune up The brightness of perception and the number of electrodes that can give you perception may decrease over time If your perceptual experience with the device changes you should contact your programming clinician for a follow up programming session Visual Rehabilitation It is important to learn how to use the device to fit your specific needs Second Sight has ...

Page 67: ...elines about your Argus II System will help to ensure that you receive the safest and most beneficial treatment Always tell any medical personnel that you have an implant in your eye and tell them where it is located If they have any questions they should contact your doctor or Second Sight at 1 818 833 5060 If you experience any unusual symptoms that you think are related to your Argus II Implant...

Page 68: ... any discomfort during stimulation First turn off your Argus II System by shutting off the VPU or taking off your glasses then call your doctor You are having any difficulty operating your Argus II System or any of the components break You feel like the information stimulation you receive from your Argus II System is getting worse You experience any unusual symptoms that you think electromagnetic ...

Page 69: ... charger push the round end of the battery against the spring in the middle of the battery slot Pushing the spring away from the charger s power cable push down until the battery is in the charging slot When inserting the battery ensure that the battery is fully seated in the charger before letting go of the battery This will prevent the battery from popping out of the charger A digital display on...

Page 70: ...flat side facing the open battery door insert the battery round end first into the battery slot The battery is shaped so that it can only be inserted into the compartment in the correct direction so you may have to rotate the battery until it slides into the slot Do not force the battery into the slot When the battery is in the correct position it will easily slide into the compartment Close the d...

Page 71: ...gure 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 Do not use the battery if the shrink wrap ...

Page 72: ...he cable depending upon how you would like to wear the VPU a Make sure the VPU is turned off before connecting the cable b Select the cable length that is appropriate for where you are wearing the VPU c Locate the end of the cable with the rectangle shaped connector This connector plugs into the end of the arm of the glasses that does not have the antenna on it d Hold the connector so that it angl...

Page 73: ...n inserting the connector into the VPU Put on the VPU The VPU can be worn many ways It can be worn on your waist using the belt holster around your neck or shoulder using the VPU Strap or you can carry it in a pocket Put on the Glasses Using both hands gently put on the glasses as you would a typical pair of glasses Adjust the cable so that it is comfortable CAUTION Do not pull the glasses cable o...

Page 74: ...o not over extend the glasses arms as this could break them Do not try to fold the arms of the glasses as this will break them Operating Instructions CAUTION Do not exchange your VPU with another patient s VPU If you use another patient s VPU you could have uncomfortable stimulation CAUTION If you experience any discomfort during the use of the device please contact your clinician or Second Sight ...

Page 75: ...y 20 seconds you will hear a musical tone The VPU then performs a series of tests These tests last 20 50 seconds You may or may not see something during these tests To change programs The Program Selector has three positions Each position has a different program that your clinician has created for different lighting and contrast conditions To choose a different program slide the switch to the desi...

Page 76: ...a tone all indicator lights on the VPU will turn off To replace the lenses To remove the lenses 1 Hold the glasses with the front of the glasses facing away from you 2 Be careful not to touch the front of the camera Place your thumbs on the inside of one of the lenses near the upper corner closest to the camera 3 Firmly push the lens away from you with your thumbs It may help to pull slightly on t...

Page 77: ... to seat it in the groove of the lens opening It may help to pull the frame slightly with your other fingers When you are finished using the system 1 Turn off the VPU 2 Disconnect the glasses from the VPU If storing the system remove the battery LED s and Audible Tones 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...

Page 78: ...ht of the VPU is blinking The battery level is low Four rapid tones The amber LED on the front right of the VPU is on The light will blink if the link is intermittent There is a loss of link between the implant antenna and glasses antenna Single gong sound The amber LED on the VPU is on VPU Error Glasses cable not connected to VPU Quick beeping tone The amber LED on the VPU is on Glasses Cable not...

Page 79: ...To remove the battery Hold the VPU with the battery door facing up Open the battery door by pushing down on the door while sliding it towards the outside of the VPU While holding your hand over the battery door opening turn the VPU so that the opening is facing down The battery will slide out of the VPU Follow the instructions supplied with the charger to recharge the battery Additional batteries ...

Page 80: ...the equipment Gently rub the areas that require cleaning 3 Use a clean dry cloth to dry the equipment after cleaning it 4 Use a soft cloth to remove smudges and fingerprints from the glasses and camera lens on the glasses CAUTION Do not use any cleaning solutions or solvents to clean the equipment This may damage the equipment or its labels Maintenance The Argus 2s system does not contain any user...

Page 81: ... hard disks 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 in use If metal objects get too close to the antenna the antenna could overheat which would cause the VPU to turn off The VPU w...

Page 82: ...ure range The temperature range for normal use should be between 32 F 0 C and 125 F 52 C The glasses can be expected to be 7 F 4 C warmer than the environment in which it is used up to 133 F 56 C at the maximum specified use temperature Handling the glasses The glasses are fragile Handle them with care especially when putting them on or taking them off Though the arms of the glasses move slightly ...

Page 83: ...function properly for more than five years but performance to date and laboratory testing suggest that it will One way the implant could fail is that it could stop responding to signals from the glasses and stop stimulating If it fails in this manner you should not experience any harmful effects In such a rare case the implant may be removed and replaced if possible and desired The VPU and glasses...

Page 84: ... or battery charger in a fire as this may cause an explosion and or the release of toxic fumes Do not dismantle the battery as some ingredients can be 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 r...

Page 85: ...arding the proper disposal of electronics to dispose of the VPU or glasses If you are exchanging or replacing your equipment through your clinician your clinician will be responsible for following these regulations Rechargeable Batteries and Battery Charger The VPU uses rechargeable batteries If you detect any leakage of fluid from the battery stop using it and replace it with a new one Dispose of...

Page 86: ...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 Disposal of Packaging Material Dispose of the shipping carton and packaging materials for the Argus 2s system components according to local regulations ...

Page 87: ...ct your doctor or programming clinician You can also use the information provided in 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 or programming clinician immediately Table 8 Troubleshooting Symptom Corrective Action The VPU does not start 1 ...

Page 88: ...art continued pressing the correct button The power button is the indented 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 If the button is pressed for less than two seconds the VPU will not turn on ...

Page 89: ... to see if this occurs again 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 on but I don t see anything 1 Check that the VPU is on by pressing the mute button If a tone is heard or a vibration occurs then the VPU is on If no sound is heard wait 1 2 minutes and p...

Page 90: ...if the alarms are muted 3 Check that the glasses cable is securely plugged into the VPU and glasses 4 If the RF link tone is sounding four quick tones in a row gently press the antenna mounted on the glasses closer to your eye If the audible tone stops and resumes when you stop pressing the antenna this indicates that your external antenna needs to be adjusted Contact your clinician to adjust the ...

Page 91: ...t 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 9 Try changing the program setting 10 Check the blue LED on the front of the VPU is not on If the blue light is on this indicates that the Network button has been accidentally pushed Stimulation should begin again in 15 seconds ...

Page 92: ...f the other program settings to see if there is an improvement The VPU is on but my perception is dimmer than usual 1 Check that nothing is blocking the camera on the glasses 2 Check that the lens on the camera is clean Refer Chapter 3 Cleaning 3 Check that there is enough lighting 4 Try inverting the image from black to white or white to black 5 Try using one of the other program settings to see ...

Page 93: ...ture If the problem continues or the antenna is getting unusually warm contact Second Sight using the contact information provided in Chapter 7 page105 Mute button not responding as expected The mute button may have been pressed more than once Re press the mute button until desired mode is achieved If the problem continues contact your clinician or use the information in Chapter 7 page 105 to cont...

Page 94: ...movement to maintain the link between the implant antenna and the glasses antenna Amber light is blinking and I heard a musical tone Low battery Promptly replace the battery with a fully charged battery The VPU is not operating as intended but I do not hear any audible tones Press mute button to verify audible tones are on If the problem persists contact your programming clinician or use the infor...

Page 95: ...ter fit and comfort and a feature was added to improve the adjustment of the antenna to help improve the RF link between the implant antenna and the glasses antenna A new digital camera was also added to the glasses to help improve performance in low light conditions The VPU was also re designed It is smaller and lighter weight A new loop mechanism allows the VPU to be held in a variety of ways us...

Page 96: ...the Argus II System In this study thirty subjects were implanted with the Argus II Implant Fourteen of these subjects lived in the United States and sixteen lived in Europe As of March 2012 subjects had been implanted for an average of 3 5 years The shortest length of implant was 1 2 years and the longest length of implant was 4 8 years One subject had the Argus II Implant removed at 1 2 years aft...

Page 97: ...iring a suture used to close the wound in the eye Five subjects had multiple serious complications some of which were treated with surgery Of these last five subjects four had a cascade of events meaning that one complication led to another complication Serious Complications Below is a list of the serious complications during the study Of the 30 subjects 4 subjects had a decrease in the pressure o...

Page 98: ...less they were a severe infection Severe infections were treated by either giving the subject a shot of medication into the eye or by giving the subject medicated eye drops As mentioned above some subjects had several serious complications More than half of the serious complications happened within 6 months of implant surgery although two happened as late as 2 years after implant Other Side Effect...

Page 99: ...aking the eye soft o 6 subjects had irritation caused by the sutures o 6 subjects had fluid collected under the choroid o 4 subjects had redness or irritation of the conjunctiva pink eye o 9 subjects had redness or irritation inside the eye o 4 subjects had bleeding in the back part of the eye o 3 subjects had blood in the front of the eye o 3 subjects had headaches o The following side effects oc...

Page 100: ...round the tack used to hold the implant to the retina o Cyst on the conjunctiva o An opening of the surgical wound where the eye tissue covers the implant o A portion of the implant wore through the tissue that covers it leaving that part of the implant uncovered o Scraping of the cornea o Dryness of the cornea o Rough spot on the cornea o Folding of the cornea o Torn suture o Decrease in how much...

Page 101: ...experienced changes in the number of electrodes that were programmed in the VPU As of March 2012 this number ranged from as few as 8 electrodes in some subjects to as many as 60 electrodes in other subjects The average number of electrodes programmed for stimulation in the VPU was 38 The stimulation limit was lower for home use than for clinical testing Because of this some electrodes that were pr...

Page 102: ...d perception of light The clinician changed the VPU programming to quad stimulation in some of these subjects in order to allow them to have perception over a larger part of the electrode array Refer to page 57 for a description of quad stimulation As of March 2012 6 of these 13 subjects were using quad stimulation In the clinical trial no attempt was made to directly compare whether quad stimulat...

Page 103: ...stem off The second test was harder than the first test In the second test called Direction of Motion subjects watched a computer screen where a white bar moved across the screen in different directions Subjects had to draw on the screen the direction that they thought the bar was moving On average subjects did better on this test with the Argus II System on versus off at each time point At one ye...

Page 104: ...ry follow up visit after implant subjects were better at doing these tasks when using the Argus II System versus when they were not using the Argus II system Use of Argus II System in Daily Life and Quality of Life Subjects completed two surveys to measure the effect of the Argus II System on their quality of life and their everyday life One survey the Massof Activity Inventory showed that during ...

Page 105: ...sults in a loss of vision The retina is the layer of tissue at the back of the inside of the eye The cells in the retina convert light into signals to nerve cells which send signals to the brain The brain then tells us what we see The disease is named for the dark deposits which appear in the retina RP can be caused by a genetic defect which will cause it to run in families Early symptoms of the d...

Page 106: ...Chapter 6 Additional Information Page 99 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 ...

Page 107: ...lace Your Implant This warranty is limited to Implant failures This warranty does not apply to failures due to surgical problems This warranty does not apply to failures due to Your medical condition An Implant failure must be confirmed by Us before it is explanted WARRANTY DISCLAIMER WE EXPRESSLY DISCLAIM ALL IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY AND FI...

Page 108: ...materials for 1 year from the date of first VPU programming or date of purchase if bought separately We further warrant that the supplied battery charger and rechargeable batteries are free from defects in workmanship and materials for 3 months from the date of first VPU programming or time of purchase if bought separately The battery charger includes the charger base and AC adaptor We will repair...

Page 109: ... claim items must be returned to Us within 30 days after receipt of replacement part s 3 We must be able to confirm the failure 4 This warranty excludes defects caused by fire floods lightning natural disasters and other calamities defined as Acts of God This warranty excludes defects caused by accident misuse abuse negligence water damage improper programming or failure to operate the External De...

Page 110: ...teries have a specified capacity which may deplete at different rates depending on the settings used and failure to recharge as specified in the operator s manual Note Per operator instructions batteries should be used promptly after receipt should not be stored for future use periodically recharged and must be kept within temperature range This warranty excludes defects caused by accessories not ...

Page 111: ...Chapter 7 Warranty Page 104 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 ...

Page 112: ...Argus 2s Retinal Prosthesis System or your suggestions to improve the product Please feel free to contact us for technical assistance replacement parts or your suggestions Second Sight Medical Products Inc 13170 Telfair Ave Sylmar CA 91342 USA Phone 1 818 833 5060 Fax 1 818 833 5067 E mail service secondsight com www secondsight com ...

Page 113: ...Chapter 7 Contact Information Page 106 Write important telephone numbers here Resource Telephone number Clinic Physician Device disposal contact ...

Page 114: ...rgus 2s system The symbols and their meanings are described below Table 10 Symbols Symbol Meaning Catalog number Serial number Lot number Date of manufacture Consult the instructions for use for important cautionary information such as warnings and precautions that cannot be presented on the medical device itself Follow instructions for use Storage temperature range ...

Page 115: ...Chapter 8 Symbols and Regulatory Classifications Page 108 Symbol Meaning Keep Dry Non ionizing radiation Radio frequency radiation Manufactured by Type BF Applied Part MR Conditional MR Unsafe ...

Page 116: ...according to each of these standards and directives For detailed information regarding electromagnetic environments please see Appendix A page 113 Table 11 Regulatory Classifications Standards Directives Regulatory Classifications IEC 60601 1 Classification Internally Powered Type BF Applied Part IP22 Device protected from touch by fingers and objects greater than 12 millimeters Protected from wat...

Page 117: ...1 Equipment Equipment in which there is intentionally generated and or used conductively coupled radio frequency energy which is necessary for the internal functioning of the equipment itself Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class B Equipment Equipment suitable for use in all establishments including your home ...

Page 118: ...ectromagnetic Immunity Classification The Argus 2s system may experience interference from ESD power frequency magnetic fields and conducted and radiated RF IEC 60601 1 11 Classification P22 Protected from touch by fingers and objects greater than 12 millimeter Protected from water spray less than 15 degrees from vertical ...

Page 119: ...ations 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: ...ceived including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for Class B Digital Device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates and can radiate radio frequency energy and if not installed a...

Page 121: ... Second Sight Medical Products Inc could void the user s authority to operate the equipment Table 12 Potential effects of EMI from devices or procedures Device or procedure Potential Effect Additional Information Patient injury Damage to the Argus 2s System Temporary Interruption of Stimulation Image Artifact a Airport screening device Page 36 Bipolar electrosurgical equipment Page 35 Bluetooth de...

Page 122: ...mulation Image Artifact a Commercial electrical equipment for example arc welders induction furnaces resistance welders etc Page 39 Communicatio n equipment such as microwave transmitters linear power amplifiers and high power amateur transmitters Page 39 Defibrillator Page 35 Diagnostic Ultrasound Page 35 Diathermy Page 28 Electric steel furnaces Page 39 Electroconvulsi ve therapy ECT Page 28 ...

Page 123: ...on Image Artifact a Electronic article surveillance EAS systems and EAS tag deactivators Page 36 Fragmatome Page 34 Hearing aids Page 37 High output ultrasound Page 39 High voltage lines power lines or generators Page 39 Home appliances Page 37 Large magnetized speakers Page 39 Laser Page 34 Lithotripsy Page 28 Magnetic resonance imaging MRI Page 29 Metal detector Page 36 Phacoemulsific ation Page...

Page 124: ...n of Stimulation Image Artifact a Radiofrequenc y identification RFID systems Page 36 Theft detector Page 36 Therapeutic ionizing radiation to the head Page 35 WiFi access point Page 37 Wireless router Page 38 a 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 ...

Page 125: ...mputed tomography scan CT scan 36 conjunctiva 1 47 contraindications 28 cornea 1 49 cyst 49 93 decrease in light perception 47 defibrillator 36 detector metal 37 theft 37 61 Device Disposal 77 device programming 56 57 diathermy 29 dizziness 49 drooping of the eyelid 47 dry eye 49 electric shock 47 electroconvulsive therapy ECT 29 electromagnetic interference EMI 2 32 index of potential effects 115...

Page 126: ...5 nausea 49 Network Connection button 17 over stimulation 48 packaging material disposal 79 pain 30 31 44 45 47 55 61 80 92 patient identification ID card 41 phacoemulsification 35 power generators 40 Precautions 29 31 pregnancy and nursing 32 pressure of the eye 92 probable benefit 50 52 95 Program Selector 16 Programming 57 quad s 58 Radio Frequency RF 3 radiofrequency identification RFID 37 reg...

Page 127: ...and storage 74 invers setting button 16 inverting the image 68 is on but my perception is dimmer than usual 85 is on but the image seems distorted 85 maintenance 73 shuts off suddenly 82 storage 75 turning off 69 turning on 68 Unapproved components 74 usage temperature range 75 VPU is on but I don t see anything 82 VPU Batteries 27 VPU Strap 18 27 Warnings 29 warranty 101 watering eye 49 WiFi 38 W...

Page 128: ......

Page 129: ...January 2021 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 ...

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