Nevertheless, special precautions need to be observed:
1.NOTE The EMISSIONS characteristics of this equipment make it suitable for
use in a residential environment (for which CISPR 11 class B is normally
required).
2.WARNING:The use of accessories and cables other than those specified by
Sunset, with the exception of cables sold by Sunset as replacement parts for
internal components, may result in increased emission or decreased immunity
of the device.
3.WARNING:The medical devices should not be used adjacent to or stacked
with other equipment. In case adjacent or stacked use is necessary, the
medical device should be observed to verify normal operation in the
configuration in which it will be used.
4.WARNING: PORTABLE RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than
30cm (12 inches) to any part of [ME QUIPMENT or ME SYSTEM], including cables
specified by the MANUFACTURER. Otherwise,degradation of the performance
of this equipment could result.
5.WARNING:Do not use mobile (cellular) telephones and other devices(such as
MRI,diathermy,electrocautery,RFID and electromagnetic security systems)
which generate strong electrical or electromagnetic fields, near the medical
device. This may result in incorrect operation of the unit and create a
potentially unsafe situation. Recommendation is to keep a minimum distance
of 7m. Verify correct operation of the device in case the distance is shorter.
15
to electromagnetic interference from other devices. Electromagnetic
interference may result in incorrect operation of the medical device and create
a potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility)
with the aim to prevent unsafe product situations, the IEC60601-1-2 standard
has been implemented. This standard defines the levels of immunity to
electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
Medical devices manufactured by Sunset Healthcare Solutions (Sunset)
conform to this IEC60601-1-2 standard for both immunity and emissions.
