9
6.0
| Adverse Reactions
1. Possible skin irritation or electrode burn under the electrodes may occur.
2. Possible allergic skin reaction to tape or gel may occur.
3.
transmitters, e.g. mobile phones or similar mobile radio equipment, airport security systems, or
metal detection devices (which themselves conform to the EMC regulations), may influence the
proper functioning of the device if such equipment is operated in close proximity and with relatively
high transmitting power.
Flex-TENS® meets EMC requirements and is designed in such a way, that under normal
conditions, there is no risk of malfunction caused by electromagnetic interference. However, in the case
of signals from high frequency transmitters, the risk of electromagnetic incompatibility when operated
in close proximity to electronic apparatus cannot be totally ruled out. In unusual circumstances,
unintended functions of the Flex-TENS® could be initiated, possibly giving rise to undesirable risks for
the patient or user such as a surge in energy level or ine ctive treatment parameters.
