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Get the free Argus II Retinal Prosthesis System Surgeon Manual - FDA

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510(K SUMMARY(06/11/12) As required by 21 CER 807.87 and 807.92 New'm 5 10(k) Number K1 13692 Applicants Name: Xenolith Medical Ltd. 1 Les hem Street, P0 Box 720 KiryatGat, 82000 Israel Phone: 97286811761
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01
Step 1: Start by carefully reading the instructions provided with the Argus II retinal prosthesis.
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Step 2: Familiarize yourself with the different components of the prosthesis, including the external hardware and the implanted device.
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Step 3: Wash your hands thoroughly with soap and water before handling the prosthesis to minimize the risk of infection.
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Step 4: Ensure that the prosthesis is charged and the battery is adequately powered.
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Step 5: Gently clean the area around the implant site with a disinfectant wipe or as instructed by your healthcare provider.
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Step 6: Carefully connect the external hardware to the implant using the provided cables and connectors.
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Step 7: Follow the specific instructions provided by your healthcare provider on how to activate and use the Argus II retinal prosthesis.
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Step 8: Practice using the prosthesis under the guidance of your healthcare provider to maximize its effectiveness.
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Step 9: Follow up regularly with your healthcare provider to monitor your progress and address any concerns or issues you may have.
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Step 10: Be patient and persistent, as it may take time to adjust to the Argus II retinal prosthesis and fully benefit from its functionality.

Who needs argus ii retinal prosformsis?

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The Argus II retinal prosthesis is designed for individuals with severe to profound vision loss due to retinitis pigmentosa (RP).
02
Retinitis pigmentosa is a genetic disorder that causes progressive degeneration of the light-sensitive retina, leading to vision loss.
03
Candidates for the Argus II retinal prosthesis must meet certain criteria, including having bare or no light perception in both eyes.
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They should also have previously demonstrated visual function, which indicates that the visual pathway from the eye to the brain is intact.
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It is important to consult with a healthcare professional specializing in visual impairments to determine if the Argus II retinal prosthesis is suitable for an individual's specific condition.
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Argus II retinal prosthesis is a type of retinal implant that helps restore some vision to individuals with certain types of blindness.
Patients with retinal degenerative diseases who have been deemed eligible for the Argus II retinal prosthesis may be required to undergo the procedure.
The Argus II retinal prosthesis is implanted by a qualified ophthalmologist during a surgical procedure.
The purpose of the Argus II retinal prosthesis is to improve visual perception and function in individuals with certain types of blindness.
Information about the implantation procedure, device settings, and patient outcomes may need to be reported on the Argus II retinal prosformsis.
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