Specifications
Affinity® Three Birthing Bed and Affinity® Four Birthing Bed User Manual
(USR025 REV 6)
53
Electromagnetic Emissions Guidance
CAUTION:
This device meets all requirements for electromagnetic compatibility per IEC 601-1-2 and the Medical
Device Directive and has been fully tested to such requirements. It is unlikely that the user will encounter
problems with this device because of inadequate electromagnetic immunity. However, electromagnetic
immunity is always relative, and standards are based on anticipated environments of usage. If the user
notes unusual device behavior, particularly if such behavior is intermittent and associated with nearby
usage of radio or TV transmitters, cell phones, or electrosurgical equipment, this could be an indication of
electromagnetic interference. If such behavior occurs, the user should try moving the interfering equipment
further from this device.
WARNING:
The Affinity® Three Birthing Bed and Affinity® Four Birthing Bed should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use is necessary, the Affinity® Three Birthing Bed and
Affinity® Four Birthing Bed should be observed to verify normal operation in the configuration in which it
will be used.
Make sure the Affinity® Three Birthing Bed or Affinity® Four Birthing Bed operates correctly when it is used near
other electronic devices.
Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.
Medical electrical equipment needs special precautions in regard to electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information supplied in this manual.
The use of accessories, transducers, and cables other than those specified, with the exception of transducers and
cables sold by the manufacturer of this device as replacement parts for internal components, may result in
increased emissions or decreased Immunity of the Affinity® Three Birthing Bed and Affinity® Four Birthing Bed.
Guidance and Manufacturer's Declaration—Electromagnetic Emissions
The Affinity® Three Birthing Bed and Affinity® Four Birthing Bed are intended for use in the electromagnetic environment specified
below. The customer or the user should make sure that they are used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment—Guidance
RF emissions
CISPR 11
Group 1
The Affinity® Three Birthing Bed and Affinity® Four Birthing Bed use RF
energy only for their internal functions. Therefore, their RF emissions are
low and are not likely to cause any interference in nearby electronic equip-
ment.
RF Emissions
CISPR 11
Class B
The Affinity® Three Birthing Bed and Affinity® Four Birthing Bed are suit-
able for use in all establishments, including domestic establishments and
those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
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