Warnings - Synapse Biomedical TransAeris Manuel De L'utilisateur

2 Warnings

2.1 Use only under the direction of a physician. The TransAeris stimulator is electrically
powered and may produce tissue damage or electrical hazard if improperly used.
• The device has accessible controls for clinical staff and NO
patient-accessible controls.
• Do NOT attempt to open the TransAeris stimulator case or attempt any unintended
modifications as this will cause a failure in the TransAeris stimulator functionality.
2.2 Use of TransAeris could interfere with some medical equipment. Some medical
equipment could interfere with the use of TransAeris. Consult the this User Manual
before having any of the following:
• Implanted cardiac pacemaker or defibrillator. Use of the TransAeris stimulator
may interfere with these devices.
• Surgery. Use of high-frequency surgical equipment may cause burns where
the electrode leads pass through the skin. Such equipment may damage the
TransAeris stimulator. Disconnect the TransAeris stimulator when high-frequency
surgical equipment is in use.
• Magnetic Resonance Imaging (MRI) test.
unsafe. Do not perform a MRI test while implanted with the TransLoc electrodes
or remove the TransLoc electrodes from the patient before a MRI test.
• Magnetic Resonance Imaging (MRI) test.
FrictionLoc connector, and surface electrode are MRI Unsafe. Remove these
components from the patient before a MRI test.
• Use of external electrical stimulation such as transcutaneous electrical nerve
stimulation (TENS) should not be done in the chest area near the electrode leads.
Unwanted diaphragm contraction could occur.
2.3 Clinicians should avoid accidental contact between connected but unused applied parts
(cable or leads) and other conductive parts including those connected to earth ground
or any device with the ground symbol.
50 8
MR The TransLoc electrode is MR
The TransAeris stimulator,
MR