Putting the Device into Operation and Functional Test
FRED easy® 11
4 Putting the Device into Operation and Functional Test
4.1 Safety Information
Danger
Explosion Hazard FRED easy® is not de-
signed for use in areas where an explosion
hazard may occur.
Also, it is not permitted to operate the defibrilla-
tor in an oxygen-enriched environment or in the
presence of flammable substances (gas) or
flammable anesthetics.
Oxygenation in the vicinity of the defibrillation
electrodes must be strictly avoided.
Oxygen concentrations below 25% of the am-
bient air are not considered dangerous. Dan-
gerous, high oxygen concentrations can only
occur in oxygen masks or in enclosed areas,
such as hyperbaric chambers.
Warning
Shock Hazard Observe the following warn-
ings. Failure to do so endangers the lives of the
patient, the user and other persons present.
−FRED easy® is a high-voltage electrotherapy
device. Only authorized personnel is permit-
ted to use these devices. Improper use of the
device can endanger life. Always follow the
instructions given in this user guide.
−Before using the device, the operator is re-
quired to ascertain that it is functioning cor-
rectly and in good operating condition. In par-
ticular, the cables, connectors and electrodes
must be inspected. Damaged parts must be
replaced immediately, before use.
−The operator is required to ensure that during
ECG analysis and defibrillation there is no
conductive connection between the patient
and other persons.
−Devices may be connected to other devices
or to parts of systems only when it has been
made certain that there is no danger to the
patient, the operators, or the environment as
a result.
In those instances where there is any ele-
ment of doubt concerning the safety of con-
nected devices, the manufacturers con-
cerned or other informed experts must be
contacted as to whether there is any possible
danger to the patient, the operator, or the en-
vironment as a result of the proposed combi-
nation of devices. Standard IEC 60601-1-1
must be complied with in all cases.
−The device is suitable for application in a
humid environment provided the regulations
concerning splash-proof equipment of IEC
60601-2-4 are strictly observed.
Warning
Equipment Failure
−Magnetic and electrical fields are capable of
interfering with the proper performance of the
device. For this reason make sure that all ex-
ternal devices operated in the vicinity of the
defibrillator comply with the relevant EMC re-
quirements. X-ray equipment, MRI devices,
radio systems, and cellular telephones are
possible sources of interference as they may
emit higher levels of electromagnetic radia-
tion.
Keep the equipment away from these de-
vices and verify its performance before use.
−If the devices are used in the vicinity of
power networks operating at a frequency of
16.7 Hz (railway systems in some coun-
tries), the 16.7-Hz filter should be activated
via the configuration menu. The filter should
be turned off, when the device is not used in
the vicinity of these networks.