Zimmer PremoPortFour, Инструкция по эксплуатации, Страница: 11 / 48

Warnings
3
Page 5
3.
Warnings
Users of the device must be trained in how to use the system properly and have
the appropriate skills.
Use in wet areas is not permitted and may in case of non-compliance lead to
considerable damage and endanger both the patient and the user.
Dispose of the packaging material properly. Make sure that it is not accessible
to children.
Remove batteries from device if it is not used for a long period of time.
The use of the device outside of the settings or applications specified in the
instructions for use may lead to hazards to the patient.
Patients may not be connected to a high-frequency surgical device at the same
time. This can lead to burns.
General safety
information
PremoPort
Four
may only be operated in accordance with these
instructions for use. All other applications are the responsibility of the
operator.
For maintenance measures, expansions, readjustments or modifications,
the provisions of the German Medical Devices Act and the Medical Device
Operator Ordinance apply.
According to the Medical Device Operator Ordinance, medical devices may
be set up, operated and used only by persons who have the necessary
training or knowledge and experience to do so.
Safety information for
setup and installation
Prior to putting the device into operation, the connection cables should be
checked for damage. Damaged cables must be immediately replaced.
The environmental conditions indicated in the “Technical information”
chapter must be observed.
Conventional computer and PC screens which do not correspond to
EN 60601-1 may not be set up in the vicinity of the patient. The minimum
distance to the patient must be 1.5 m.
PremoPort
Four
must not be operated in rooms where there is a risk of -
explosion.
For reasons of functional safety, diagnostic devices should not be operated
in the vicinity of devices which generate large electromagnetic fields, such
as X-ray or diathermy equipment or MRI machines. A minimum distance of
5 m must be ensured. Protective measures such as shielding wallpaper,
shielding plaster or shielding curtains can reduce this distance.