ELECTROmAGNETIC COmPATIBILITY (EmC)
EN
C
60601
This device must
be separated from
household waste
and recycled as
electronic waste
Expected service life is min. 400 hours.
E L E C T R O m A G N E T I C C O m P A T I B I L I T Y ( E m C )
Cryo Cuff IC has been tested and found to comply with the electromagnetic compatibility (EMC) limits
for medical devices to IEC 60601-1-2. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation .
CAUTION:
Medical electrical equipment requires special precautions regarding EMC and must be
installed and operated according to these instructions . It is possible that high levels of radiated or conducted
radio-frequency electromagnetic interference (EMI) from portable and mobile RF communications
equipment or other strong or nearby radio-frequency sources, could result in performance disruption
of the system . Evidence of disruption may include equipment ceasing to operate, or other incorrect
functioning. If this occurs, survey the site of disruption, and take the following actions to eliminate the
source(s).
•
Turn equipment in the vicinity off and on to isolate disruptive equipment .
•
Relocate or reorient interfering equipment.
•
Increase distance between interfering equipment and your system.
•
Manage use of frequencies close to the system frequencies.
•
Remove devices that are highly susceptible to EMI.
•
Lower power from internal sources within the facility control (such as paging systems).
•
Label devices susceptible to EMI.
•
Educate clinical staff to recognize potential EMI-related problems.
•
Eliminate or reduce EMI with technical solutions (such as shielding).
•
Restrict use of personal communicators (cell phones, computers) in areas with devices susceptible to
EMI .
•
Share relevant EMI information with others, particularly when evaluating new equipment purchases
which may generate EMI.
•
Purchase medical devices that comply with IEC 60601-1-2 EMC Standards (3 V/meter EMI immunity,
limit interference level to 0.0014 V/meter).
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IP21