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ELECTROMAGNETIC COMPATIBILITY (EMC)
EN
Safety Mark
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 AT 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).
Humidity Limits
US
CE Mark
Atmospheric Pres-
sure Limits
8
Degree of Ingress
Protection
IP21
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