Synapse Biomedical TransAeris Manuel De L'utilisateur page 51

2.4 Safety has not been established for the use of the device during pregnancy.
2.5 Safety has not been established for the use in patients with epilepsy.
2.6 Cardiac interference. Before conditioning, test interference with cardiac rhythm.
Monitor electrocardiogram (ECG) while stimulating at maximal settings. If interference
is observed, decrease stimulation settings below level of interaction, turn off identified
electrodes, or remove identified electrodes.
2.7 Do NOT come in contact with TransLoc electrodes during emergency defibrillation.
It may lead to electric shock to caregivers.
2.8 ELECTROMAGNETIC INTERFERENCE WARNING: Some electrically powered
equipment gives off electromagnetic waves which could interfere with TransAeris
systems. When using your TransAeris system around electrical equipment, check
the TransAeris stimulator screen to make sure the TransAeris system is working.
2.9 Do follow the electromagnetic compatibility (EMC) information provided. The
TransAeris stimulator needs special precautions regarding EMC. To reduce the
possibility of interference on the TransAeris stimulator from other electrical equipment
or the TransAeris stimulator effecting other electrical equipment, do not use cables
or accessories with the TransAeris stimulator other than those specified.
2.10 RF COMMUNICATION WARNING: Portable and mobile RF communication equipment
may affect medical electrical equipment. Ensure proper function of TransAeris when
using around such equipment.
2.11 ELECTRO-STATIC DISCHARGE (ESD):
implanted but not connected to the FrictionLoc connector, use caution when
handling the electrode leads. Before touching the electrode leads, touch the
patient to equalize the electrostatic potential.
2.12 FLAMMABILITY WARNING: Do NOT use TransAeris system in an oxygen enriched
environment, such as a hyperbaric oxygen chamber, or near a flammable anesthetic
mixture with air, oxygen, or nitrous oxide. This could cause a fire or explosion.
o
After the TransLoc electrode has been
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