Environmental Precautions; Possible Adverse Effects - Synapse Biomedical TransAeris Manuel De L'utilisateur

4 Environmental Precautions

The TransAeris stimulator has been carefully designed and tested to ensure reliability during
normal use. However, electronic devices are susceptible to many environmental stresses.
To avoid damage to the TransAeris stimulator, observe the following precautions:
4.1 Do not expose the stimulator to excessive moisture, heat or severe mechanical
shock. If display indicates system failure or device exposed to excessive moisture,
heat or shock, disconnect the TransAeris stimulator and contact Synapse Biomedical
Customer Service.
4.2 To protect the TransAeris against damage due to mechanical shock. Do NOT drop the
TransAeris. The TransAeris may break and not be available for use when needed. The
TransAeris stimulator should remain in the plastic packaging until needed.
4.3 To protect the TransAeris against damage due to moisture, Do NOT submerge
the TransAeris in liquid. The TransAeris may quit working and not able to use
when needed.
4.4 Avoid contaminating the patient cable connections with blood or other body fluids.
4.5 Do not attempt to open the TransAeris. The TransAeris is sealed at the factory
and opening the TransAeris will damage the device and void the warranty.
Other environmental factors may impact proper performance of the TransAeris in the hospital
setting. Use of appropriate environmental health and safety practices will help prevent
environmental damage to the TransAeris.

5 Possible Adverse Effects

Possible adverse effects from the use of TransAeris system may include:
• Cardiac interaction
• Lead breakage
• Unretrieved device fragment
• Electrode dislodgement
• Skin infection
• Skin sensitivity due to adhesive
• Pain or discomfort due to stimulation
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