Radio Regulatory Compliance
Regulatory and Safety Information
7-2 Efficia CM Series Network Configuration Guide
Anyone who connects additional equipment to the signal input port or signal output port
configures a medical system and is therefore responsible to ensure that the system
complies with the system requirements of standard EN Standard 60601-1. If in doubt,
contact the Philips Customer Care Center or your local Philips representative.
It is essential that all personnel in the care of individuals or the service of equipment
associated with patient care within the context of a clinical setting, service attention or
otherwise, provide for the proper handling of ePHI (electronic protected health
information) or PHI (protected health information) by maintaining the confidentiality,
integrity, and the availability of ePHI data.
Each organization using this product must provide the protective means necessary to
safeguard ePHI/PHI consistent with each country law, code and regulation and
developed and maintained company policy with respect to managing ePHI/PHI. While
the handling of ePHI is outside the scope of this document, in general each organization
is responsible for the identification of who has access to ePHI/PHI data and under what
conditions an individual has authorization to use that data, how ePHI/PHI is stored and
the conditions by which it is stored, and finally how ePHI/PHI is transmitted and the
conditions under which that data is transmitted.
Warning If multiple instruments are interconnected or if multiple instruments are connected to
a patient, the sum of the leakage currents may exceed the limits given in
IEC/EN60601-1.
Electromagnetic interference may cause disruption of performance. Protect the
monitor from sources of intense electromagnetic radiation. This device is designed to
provide resistance to electromagnetic interference; however, because of the
proliferation of radio-frequency transmitting equipment and other sources of
electrical noise (such as cellular phones, mobile two-way radios, and electrical
appliances) in the healthcare environment, it is possible that high levels of such
interference due to close proximity or strength of a source, may result in disruption of
performance of this device. Disruption may be evidenced by erratic readings, cessation
of operation or other incorrect functioning. If this occurs, the site of use should be
surveyed to determine the source of this disruption, and actions taken to eliminate the
source. If you need assistance, contact the Philips Customer Care Center or your local
Philips representative.
Radio Regulatory Compliance
Federal Communication Commission Interference Statement
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to other device,
radio or television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one of the following
measures:
1. Reorient or relocate the receiving antenna.
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