Synapse NeuRx Handbuch Seite 16

10.6 Surface Anode
The surface anode is an adhesive electrode that is placed on the skin during the
intraoperative procedure. The anode is manufactured by Axelgaard and uses a
proprietary hydrogel adhesive to adhere to the surface anode to the skin.
10.7 Electrode Delivery Instrument
The Electrode Delivery Instrument is used intraoperatively to implant the
electrodes.
Note: Section 10.7.1 describes the Reusable (after cleaning and re-sterilization
by the Clinical site) Electrode Delivery Instrument (23-0031 Ref. IFU 77-0052).
Section 10.7.2 describes the Disposable Electrode Delivery Tool (21-0039-99
Ref. IFU 77-0086). Both tools have the same indications for use.
10.7.1 Reusable Electrode Delivery Instrument
The Reusable Electrode Delivery Instrument is an 11mm durable
laparoscopic instrument device. It is manufactured from surgical stainless
steel (304SS) which has been coated with chromium using the MEDCOAT
2000 electroplating process. The proprietary MEDCOAT 2000 process
applies chromium to the surface of the stainless steel parts creating a low
friction surface that is lubricious and biocompatible.
The barbed intramuscular electrode is loaded in the lumen of the
instrument with the de-insulated barb extending out of the needle. The
skirt of the polypropylene barb is loaded inside of the needle. When the
needle is extended and inserted between the muscle fibers, parallel to the
diaphragm surface, the de-insulated barb catches on the fibers and the
lead is drawn out of the lumen as the instrument is withdrawn. The
instrument is provided non-sterile to the end-user with instructions for
cleaning and sterilization.
Figure 1: Reusable Electrode Delivery Instrument
10.7.2 Disposable Electrode Delivery Tool
The Reusable Electrode Delivery Instrument is a 10mm single patient use
disposable laparoscopic instrument. The barbed intramuscular electrode
is loaded in the lumen of the instrument with the de-insulated barb
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