Surgical Components - Synapse NeuRx Handbuch

10.

SURGICAL COMPONENTS

10.1 Sterilization
With the exception of the Clinical Station and Electrode Delivery Instrument,
surgical components are provided in a double-pouch packaged in medical-grade
Dupont™ Tyvek® pouches and EtO sterilized. The Electrode Delivery Instrument
is steam-sterilized at the surgical site and the Clinical Station is not sterilized. The
Disposable Electrode Delivery Tool is Gamma (Sterile R) sterilized and packaged
in a sealed clear plastic Tyvek sterile tray.
10.2 Mapping Instrument
The initial step in the surgical implementation is the laparoscopic mapping of the
diaphragm. This may be performed by introducing and connecting to an available
laparoscopic dissector for stimulation or using the optional 5mm mapping
instrument. Either instrument is used to stimulate the inferior surface of the
diaphragm in a grid pattern to identify optimal implantation sites of the
intramuscular electrodes. The connected laparoscopic dissector may be applied
to sequential sites on the diaphragm by the surgeon and stimulated. Optionally,
the mapping instrument may be applied to sequential sites on the diaphragm by
the surgeon and secured by applying the operating room vacuum through the
central lumen of the probe. Stimulation is applied in either a twitch or burst mode
from the clinical station to elicit an abdominal pressure change.
10.3 Transducer to Trocar Pressure Tube
A one-meter section of PVC tubing, with male Luer lock connectors on either end,
is used to connect a Trocar port to the solid-state pressure sensor. The long length
of the tube permits connection to the pressure sensor outside of the sterile field.
The transducer to trocar pressure tube is packaged in Tyvek packaging and
sterilized by ethylene oxide exposure.
10.4 Solid-State Pressure Sensor
A differential, 1 PSI full scale, pressure sensor transduces the abdominal pressure
changes to an electrical signal for the clinical station. It connects to the pressure
tube with a female Luer lock and to the clinical station with a positive locking
medical-grade connector. The electrical signal provides an indication of relative
pressure change.
10.5 Cable Set
A set of cables with touch-proof connectors are used to connect off the sterile field
from the mapping instrument to the clinical station. A set of 3m meter cables
connect to the mapping instrument or clip leads to test implanted electrodes.
Another cable connects from the surface anode to the clinical station.
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