Sterilization , Storage , And Handling - Neuropace RNS System User Manual

Responsive Neurostimulator System
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TERILIZATION TORAGE
Handling Products
The products of the RNS
Handle the lead with care.
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Bending, kinking, and stretching of the lead may cause lead damage.
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Do not reinsert stylet into the lead once it has been removed.
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Do not tighten sutures over the lead body.
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Only use the torque driver to secure the connector cover.
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Resterilization of Implantable Products
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The RNS Neurostimulator is provided sterile. DO NOT RESTERILIZE. Implantable RNS
products are single-use-only. Do not resterilize or re-implant any explanted products of the RNS
System. Return the explanted neurostimulator and leads to NeuroPace.
"Use by" Date
Do not implant or use any system component after the "Use by" date. Return all such product to
NeuroPace.
Damaged Packaging
Prior to product use, inspect the sterile packages for seal integrity. If the packaging appears to be
wet, punctured, or damaged, the contents may no longer be sterile and these product(s) should be
returned to NeuroPace for replacement.
Product Storage
Components should be stored in a clean and secure area with a room temperature of approximately
14 to 28 degrees Celsius.
Explant and Disposal
Program all detection and therapy functions to DISABLED prior to explanting and shipping the RNS
Neurostimulator. Return the explanted neurostimulator and leads to NeuroPace. NeuroPace will
provide shipping containers if requested.
DO NOT incinerate the neurostimulator; explosion can occur if the neurostimulator is exposed to
incineration or cremation temperatures.
Return / Disposal of Programmer and Wand
The programmer and wand should be returned to NeuroPace if you are no longer using them. They
contain electrical parts that need to be disposed of in accordance with local regulations.
Wand Maintenance, Cleaning and Sterilization
The wand is not user-serviceable and requires no maintenance. The wand can be cleaned by wiping
with water. It can be placed in a sterile bag for use in the sterile field. DO NOT STERILIZE the wand.
Electrostatic Discharge (ESD) / Static Electricity
The ports on the programmer laptop may be sensitive to electrostatic discharge (ESD) / static
electricity. Handle the programmer laptop ports carefully. If exposed to electrostatic discharge, the
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RNS System User Manual
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AND ANDLING
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System are to be handled with extreme care.
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