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Compliance Statements
Electromagnetic Compatibility (EMC)
The IS-5500 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).
ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES for RF emissions class B
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The IS-5500 is intended for use in the electromagnetic environment specified below. The customer or the user of the IS-
5500 should assure that it is used in such an environment.
Emissions Tests Compliance Electromagnetic Environment Guidance
RF Emissions CISPR 11 Group 1 The IS-5500 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.
RF Emissions CISPR 11 Class B The IS-5500 is suitable 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 IEC
61000-3-3
Complies
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