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.
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-IT® could be initiated, possibly giving rise to undesirable risks for the patient or
user such as a surge in energy level or ineffective treatment parameters.