Boston Scientific WaveWriter Alpha Gebrauchsanleitung Seite 5

Intended Use
Intended Use
The Boston Scientific Implantable Pulse Generator (IPG) is an implanted medical device intended to
generate stimulation that is delivered via Leads to the spinal cord or peripheral nerves.
The Port Plug is intended to close an unused port of the Boston Scientific Implantable Pulse Generator
(IPG).
The Hex Wrench is intended to be used to tighten or loosen a Setscrew (found in Adapters, Connectors,
Splitters, Lead Extensions, Anchors, and IPGs).
The Pairing Magnet is intended to initiate pairing of a compatible Boston Scientific Implantable Pulse
Generator with a Clinician Programmer or Remote Control.
Device Description
The WaveWriter Alpha™, WaveWriter Alpha 16, WaveWriter Alpha Prime, and WaveWriter Alpha
Prime 16 Implantable Pulse Generators (IPG) are multi-channel, multi-electrode devices capable of
providing flexibility in conjunction with ease of programming. The IPGs are programmed using a Clinician
Programmer with proprietary programming software. After the IPGs are programmed, they are controlled
using a handheld Remote Control.
WaveWriter Alpha and WaveWriter Alpha 16 IPGs are rechargeable. WaveWriter Alpha Prime and
WaveWriter Alpha Prime 16 IPGs are non-rechargeable. References to the Charging System or charging
process are applicable only when using rechargeable SCS IPGs.
The Port Plug is inserted into any unused port of the Boston Scientific IPG.
The Hex Wrench is inserted into the Setscrew and rotated to tighten or loosen the Setscrew.
The Pairing Magnet is a 21.5 cm neodymium magnet used to initiate pairing of a compatible Boston
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Scientific Implantable Pulse Generator with a Clinician Programmer or Remote Control.
Radiopaque Identification Tag
The IPG contains a radiopaque identification tag. The identification tag is visible using standard X-ray
procedures and will help identify the device model number without performing a surgical operation.
SC-1216 SC-1232 SC-1416 SC-1432
Implantable Pulse Generator
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