Precautions - Synapse Biomedical TransAeris Manuel De L'utilisateur

3 Precautions

The TransAeris stimulator has been carefully designed and tested to ensure reliability during
normal use. However, electronic devices are susceptible to stresses. To avoid damage to the
TransAeris stimulator, observe the following precautions:
3.1 RANDOM FAILURES –
The physician should be aware that operational failure of the TransAeris
stimulator can occur as the result of battery depletion, mishandling, or
random component failure.
Possible operational failures of the TransAeris stimulator can include the following:
• No output or erratic output
• No sensing or erratic sensing (e.g. during self-testing)
• False indicator signals
• Inappropriate variance of rate and output intensity
• Loss of control of rate, output, intensity, or power
If loss of control of rate, output, intensity, or power occurs, and it is not due to a
low battery, disconnect the TransAeris stimulator from the patient, contact Synapse
Biomedical Customer Service to return it for evaluation.
3.2 Service condition – Before each use, evaluate the TransAeris stimulator for damage
and observable defects. Do not use the TransAeris stimulator if the case is cracked,
the controls are not functioning, the displays are not working, or if the controls,
displays, or connectors are broken.
3.3 The TransAeris stimulus artifact may be seen on monitored bio-potential signals
such as continuous ECG monitoring.
3.4 The TransAeris stimulator is designed for single-patient use. Dispose of the device
when finished using on a patient. Do NOT reuse. Reuse may lead to transmission
of infection.
3.5 TransLoc leads, FrictionLoc
fracture of leads or cables may result in failure of the TransAeris stimulator. Inspect
exiting electrode leads and cables for damage before use.
3.6 To avoid patient entanglement with the cable, keep TransAeris close to the patient
at all times when in use.
3.7 If you think the device is not providing enough stimulation, then consult this manual
or call Synapse Biomedical Customer Service. This could mean that the TransAeris
may not cause the patient's diaphragm to contract.
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connectors, and cables – Improper connection or
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