Compliance Statements - DJO Donjoy IceMan CLEAR3 Instrucciones De Uso

COMPLIANCE STATEMENTS

ELECTROMAGNETIC COMPATIBILITY (EMC)
Iceman 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 (3V/meter EMI immunity, limit interference level to 0 .0014
V/meter) .
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