in electric shock.
Warning: Only use United States Environmental Protection Agency
(EPA) registered products for cleaning/disinfection of the C1 device.
Warning: Do not use damaged equipment, sensors or accessories.
This may result in bad performance of the device or patient/operator
injury.
Warning: There are no user serviceable parts inside the C1 device.
The C1 device should be serviced by authorized parties only. Service
performed by non-authorized parties may affect data analysis and
result in possible incorrect treatment. The warranty is void if the C1
device is opened.
Warning: No modification of the C1 device is allowed. Un-authorized
modifications may affect data analysis and result in possible incorrect
treatment.
Warning: External equipment and all auxiliary devices intended for
connection to signal input, signal output or other connectors shall
comply with the relevant product safety standards, e.g. IEC 60950-1
for IT equipment and the IEC 60601 series for medical electrical
equipment, to prevent electric shocks. In addition, all such
combinations –systems –shall comply with the safety requirements
stated in the general standard IEC 60601-1, edition 3/3.1, clause 16.
Any equipment not complying with the leakage current requirements
in IEC 60601-1 shall be kept outside the patient environment, i.e. at
least 1.5 m from the patient support. Any person who connects
external equipment to signal input, signal output or other connectors
has formed a system and is therefore responsible for the system to
comply with the requirements. If in doubt, contact a qualified medical
technician or your local representative.
Caution: After connecting a new auxiliary signal to the C1 connectors
OR after modifying the connection of the auxiliary signals OR after
changing the mode of the auxiliary devices signal output, always
verify the correct setup by performing an actual recording, making
the auxiliary device create a known signal, and monitoring the
appearance and values measured in the recording software, in order
to prevent signals that would lead to incorrect interpretation and
possible incorrect treatment.
Warning: All the auxiliary devices connected to the C1 device should
be powered from a single power strip to ensure a common ground,
avoid ground potential difference skewing or disturbing the signals
and thus prevent possible incorrect treatment.
Warning: The C1 device may not be used for direct patient
connections where failure to operate can cause injuries or death of
the patient.
Warning: Only use power supply FRIWO MP115 Medical-7555M/12
with the C1 device. The use of an incorrect power supply may result
in electric shock or cause the device to overheat, which may result in
patient/operator harm.
