Intended Use; Explanation Of Symbols - Synapse NeuRx Handbuch

1.0

INTENDED USE

The NeuRx Diaphragm Pacing System (NeuRx DPS
support in patients with diaphragm dysfunction of neuromuscular origin who
require chronic ventilatory support because of diaphragm paralysis. The
device is indicated in patients with high-level spinal cord injury, whose
remaining phrenic nerve, lung and diaphragm muscle function are sufficient
to accommodate electrical stimulation.
2.0

EXPLANATION OF SYMBOLS

The Warning symbol precedes warning information that mitigates a risk that is not
obvious to the operator. Indicates that a potentially hazardous situation which, if
not avoided, could result in harm to the operator or patient.
Y
The Caution symbol appears next to precautionary information when the intention
is solely to inform. Indicates that a potentially hazardous situation which, if not
avoided, may result in minor or moderate personal injury or property damage. This
word is used to also alert against unsafe practices.
M
The Manufacturer symbol appears next to the manufacturer's name and address.
h
The Reference symbol appears preceding the part number for the device. The
part number is a unique numeric identifier for the device.
g
The Lot symbol appears preceding the lot number for a device.
manufactured at the same time using identical material and parts will share a
common lot number.
f
The Serial Number symbol appears on devices that require unique identification.
H
The Use Until symbol appears on devices that have an indication of the date by
which the device should be used. The date is expressed as the year and month,
with the month referring to the end of the month.
N
The Manufactured Date symbol appears on devices as an indication of the date
of manufacture. The date is expressed as the year and month.
l
The Temperature Limits symbol appears on packages of devices as an indication
of the storage and transit temperature limits. While the symbol appears on actual
devices as an indication of the operational temperature limits.
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3
) provides ventilatory
Devices