Electromagnetic Compatibility; General Notes - Dräger Infinity Acute Care System M540 Instructions For Use Manual

Electromagnetic compatibility

The separation distances are written with regard to
the M540. The numbers provided will not guarantee
faultless operation but should provide reasonable
assurance of such. This information may not be ap-
plicable to other medical electrical equipment, and
older equipment may be particularly susceptible to
interference.

General notes

The M540 patient monitor and its radio are de-
signed and manufactured in a way that ensures
that the emission limits for RF (Radio Frequency)
energy, as defined by the FCC (Federal Communi-
cations Commission), the RSS (Radio Standards
Specifications), by ETSI and by IEC/EN 60601-1-2,
will not be exceeded. These limits are part of inter-
national safety standards that are defined by inter-
national committees.
The radio in the M540 patient monitor complies with
Part 15 of the FCC rules. Operation is subject to the
following two conditions: (1) this device may not
cause harmful interference, and (2) this device
must accept any interference received, including in-
terference that may cause undesired operation.
Medical electrical equipment needs special precau-
tions regarding electromagnetic compatibility
(EMC) and needs to be installed and put into ser-
vice according to the EMC information provided in
this manual.
Portable and mobile RF communications equip-
ment can affect medical electrical equipment.
Electromagnetic emissions
Emissions
RF emissions (CISPR 11)
Instructions for use Infinity Acute Care System – Infinity M540 SW VG4.n
Cables and accessories not specified within the in-
structions for use are not recommended. Using oth-
er cables and/or accessories may adversely impact
safety, performance and electromagnetic compati-
bility (increased emission and decreased immuni-
ty).
The equipment should not be used adjacent to or
stacked with other equipment; if adjacent or
stacked use is inevitable, the equipment should be
observed to verify normal operation in the configu-
ration in which it will be used.
Low level signals such as ECG are particularly sus-
ceptible to interference from electromagnetic ener-
gy. While the equipment meets the testing de-
scribed below, it is not a guarantee of perfect oper-
ation, the 'quieter' the electrical environment the
better. In general, increasing the distance between
electrical devices decreases the likelihood of inter-
ference.
NOTE
The equipment is intended for use in the electro-
magnetic environments specified below. The user
of this equipment should assure that is used in
such an environment.
Compliance according to...
Group 1
Electromagnetic environment
The equipment uses RF energy only
for its internal function. Therefore, its
RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
Technical data
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