External Components - Synapse NeuRx Handbuch

8.0

EXTERNAL COMPONENTS

8.1 NeuRx DPS Stimulator
The patient-external pulse generator (EPG) is an external four-channel battery-
powered device that controls the stimulus output and respiratory timing. The four
output channels are independently controlled, capacitively-coupled, biphasic
outputs with a common return. The device is packaged in an impact-resistant
plastic enclosure with patient cable connector on the top, display and power
buttons on the front and replaceable battery compartment on the back. A
programming connector is located in the battery compartment for connection to the
clinical station. The EPG has no controls that allow modification to any parameter
settings.
8.2 Patient Cable
A five-conductor cable is provided that connects from the external pulse generator
to the electrode connector socket. The pulse generator end of the cable is a
positive locking ODU medical-grade push-pull connector. The cable is a silicone
jacketed, multi-conductor, shielded cable that is 0.75m in length. The electrode
connector end is a custom-molded five conductor connector. It is a precision
mated strip of pins embedded in the molded PVC. The patient cable conducts the
electrical signals from the controller unit to the implanted electrodes. The cable is
provided non-sterile to the end-user and the cable assembly has passed
biocompatibility testing.
8.3 Electrode Connector Socket Kit
Each electrode is terminated into a precision ITT Canon socket. The individual
sockets are crimped onto the electrode and inserted into a carrier strip. The
sockets are inserted into the carrier strip in a set sequence to mate with the
patient cable. The crimp connections are protected with a strain-relief boot.
8.4 Strain Relief Boot
The boot is a urethane strain relief for the electrodes that connect at the
connector block. It is composed of a medical-grade urethane and is molded by
Synapse. Once the electrodes are terminated in the connector socket block, the
boot shell is backfilled with silicone adhesive. Once the adhesive is filled in the
boot, the boot/assembly block is placed into the connector holder. The urethane
boot is packaged as part of the Surgical Connector Kit in a metalized barrier bag
with a desiccant so as to minimize exposure to moisture. It is supplied non-sterile
to the end-user.
8.5 Connector Holder
The connector holder is an adhesive bandage that has a clip on the surface that
secures the connection between the electrodes and the patient cable. The
adhesive bandage is MED5322 hypoallergenic fabric medical tape intended for
applications to the skin for sustained periods. The bandage can remain in place
on the skin for up to 7 days.
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