BaehrTec A2000 operating instructions
English – V101 - effective10/13
Page 11/58
2.3.3
Information on electromagnetic compatibility
We would like to point out that due to EN 60601-1 on the electromagnetic compatibility of
electromedical devices that:
•
medical electrical devices are subject to special precautionary measures in
terms of electromagnetic compatibility and must therefore be put into operation
in accordance with the requirements of these operating instructions.
•
portable and
mobile high-frequency communication facilities may affect the
functionality of electrical devices.
•
in order to fulfil EMC requirements under EN 60601-1, only original cables,
accessories and replacement parts may be used.
For the operation of your device, you may only use power cables that have
been approved by the manufacturer. If you require a new cable, please
contact the manufacturer. Operating the device using a different cable is
not permitted.
2.3.4
Safety guidelines
The device is not authorised for operation in potentially explosive areas.
Before every application, the operator must make sure of the functional safety and
proper condition of the device.
Improper handling, maintenance and care may lead to premature
deterioration and malfunctions.
This can result in a reduced product life.
It is therefore important to clean and care for the device regularly and
properly and to send the device regularly for service (pay attention to
service display or within 24 months at the latest)!
Damaged functional parts can cause damage or injuries to persons or
objects. Furthermore this may result in (even greater) damage to your
device.
It is therefore important to stop your work immediately and
disconnect the device from the mains if functional parts are damaged,
then contact the service team.
Electromagnetic fields may affect the functionality of implanted
systems (e.g. pacemakers).
Please therefore ask your patients before the treatment whether they
have any such systems fitted.
Due to the complex interactions between electric devices and mobile
telephones, it is possible that mobile phones that are switched on may
affect the device, even though the device fulfils the applicable
requirements relating to electromagnetic fields.
Therefore, please do not operate any mobile telephones during your
work, and instruct your patients to turn off their mobile phones during the
treatment.
You should also therefore set aside any electronic devices which may
be the source of any interaction (e.g. hearing aids etc.) during operation.
Alternatively, the distance between the device and the upper body of
the person receiving the treatment must be at least 50 cm in order to be
able to exclude any functional interference.
