Cautions; Device Description And Principles Of Operation - Synapse NeuRx Handbuch

4.0

CAUTIONS

· This device should be kept out of the reach of children, pets or pests.
· The NeuRx DPS is a body worn device kept close to the body and the patient cable
should NOT be allowed to hang loosely. This is to avoid the potential of any
strangulation. The patient cable should be positioned appropriately to not allow
any hanging loops.
· Do not expose the pacing device to excessive moisture, heat, extended sun light,
excessive dust or lint, or severe mechanical shock. If display indicates system
failure, pain is felt at the electrode exit site, or device exposed to excessive
moisture, heat or shock, the patient should use the back-up means of breathing
help and stop use of the device.
· Precautions should be observed when there is a tendency to hemorrhage
following acute trauma or fracture, following recent surgical procedures when
muscle contraction may disrupt the healing process, or where sensory nerve
damage is present.
· Some patients may feel skin irritation, sensitivity, or have an allergic reaction
because of the NeuRx DPS.
This may be due to:
o The stimulation
o The adhesive on the skin bandage.
o The transparent dressing used over the gauze that covers the electrode
wires. (Tegaderm™ and Op-Site™ are examples of transparent dressings).
Irritation can usually be reduced by changing the settings of the EPG or removing
the adhesive.
· To protect the NeuRx EPG against damage due to moisture, Do NOT allow the
NeuRx EPG to get wet. This includes during bathing, showering, swimming, or
any other activity in which you could get wet The EPG may quit working and not
be available for use when needed.
· If the pacing device is not to be used for an extended period or in storage, please
remove the primary battery to prevent any possible damage.
5.0

DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

· The NeuRx Diaphragm Pacing System
breathe by using electrical stimulation to contract the muscles.
· It is implanted using standard laparoscopic surgical techniques in an outpatient
procedure
· The implanted intramuscular diaphragm electrodes are connected to the NeuRx
External Pulse Generator (EPG) (external) using the patient cable and the
electrode connector, which is secured to the patient using the connector holder
bandage.
®
is a system designed to help patients
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