EDAN PA Series User Manual page 8

PA Series Biofeedback and Stimulation System User Manual
supplying the system.
14 Multiple portable socket-outlets shall not be placed on the floor. An additional
multiple portable socket-outlet or extension cord shall not be connected to the
system.
15 Only accessories supplied by the manufacturer can be used.
16 Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the device. The
operation or use of non-approved equipment or accessories with the device is
not tested or supported, and device operation and safety are not guaranteed.
17 Using accessories other than those specified by the manufacturer may result
in increased electromagnetic emissions or decreased electromagnetic
immunity of the device.
18 Make sure that all the components and accessories are connected correctly
and checked before powering on.
19 No part of the device is intended to be maintained by the user. Unauthorized
servicemen shall not open the enclosure. Otherwise, safety hazards may
happen.
20 The mains plug is used as isolation means from supply mains. Position the
device in a location where the operator can easily access the disconnection
device.
21 The device should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the device should be observed
to verify normal operation in the configuration in which it will be used.
22 The medical electrical equipment needs to be installed and put into service
according to the EMC Information provided in this user manual.
23 The device should be operated under certain circumstances, such as power
supply, humidity and altitude.
24 Portable and mobile RF communications equipment can affect medical
electrical equipment, refer to section A3.4 Recommended Separation
Distances.
25 Do not service or maintain the device or any accessory which is in use with a
patient.
26 The assembly and modifications of the device during actual service life shall
be evaluated based on the requirements of IEC60601-1.
27 Only electrodes recommended by the manufacturer should be used in case of
skin reactions, burns or other hazards caused by excessive current densities.
WARNING
5
Safety Guidance