General Description; Safety Features - Synapse Biomedical TransAeris Manuel De L'utilisateur

1.3 GENERAL DESCRIPTION

TransAeris is a percutaneous intramuscular diaphragm stimulator for temporary use in the
™
hospital setting. The system consists of implantable stimulating TransLoc
disposable/single-use FrictionLoc
external stimulator.
• The system has four stimulating, intramuscular TransLoc electrodes to be implanted
into the diaphragm for motor point diaphragm stimulation.
• Two stimulating TransLoc electrodes shall be placed into each hemi-diaphragm.
• TransLoc electrodes are tunneled to two percutaneous exit sites on the respective
lateral chest region.
• A single left and right FrictionLoc connector will provide an electrical interface from
the TransLoc electrodes to a patient cable.
• The patient cable with left (blue) and right (green) identifiers is integrated into the
TransAeris stimulator.
• TransAeris stimulator has a user interface for clinical control.

1.3.1 Safety Features

The TransAeris includes the following safety features:
• Self-test function
• Battery life indicator
• The display will indicate by counting down the number of days left that the
TransAeris will function
• At the end of 30 days, the TransAeris will shut down immediately
• Lock feature to prevent accidental change of parameters
• Safe, two-step operation to turn off the TransAeris to avoid unintended shutdown
• Electrostatic protection
• Minimized susceptibility to electromagnetic and magnetic interference
48 6
connectors, and a disposable/single-use portable
™
electrode leads,
®