4
Precautions for Use
Declaration of Conformity with FCC and Canadian Ministry of
Health Rules for Electromagnetic Compatibility
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Nonin Medical, Inc., of 2605 Fernbrook Lane North, Plymouth, Minnesota, 55447,
declares under its sole responsibility that the Models 4000 and 4100, to which this
declaration relates, comply with part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) this device may not cause harmful interference,
and (2) this device must accept any interference received, including interference that
may cause undesired operation.
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Ministry of Health (Canada), Safety Code 6: standards include a substantial safety
margin designed to ensure the safety of all persons, regardless of age and health. The
exposure standard for wireless mobile phones employs a unit of measurement
known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is
1.6W/kg.
Federal Communications Commission (FCC) Notice
This equipment has been tested and found to comply with the limits for a class B 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. If not installed and
used in accordance with the instructions, it may cause harmful interference to 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 or more of the following
measures: (1) Reorient or relocate the receiving antenna, (2) Increase the distance between
the equipment and the receiver, (3) Connect the equipment to an outlet on a circuit
different from the outlet where the receiver is connected, or (4) Consult the dealer or an
experienced radio/TV technician for assistance.
The Model 4100 wrist-worn patient module is designed and manufactured not to exceed
the emission limits for exposure to radio frequency (RF) energy set by the Federal
Communications Commission of the U.S. Government. These limits are part of
comprehensive guidelines and establish permitted levels of RF energy for the general
population. The guidelines are based on the safety standards previously set by both U.S.
and international standards bodies. This EUT has been shown to be capable of
compliance for localized specific absorption rate (SAR) for uncontrolled environment/
general population exposure limits specified in ANSI/IEEE Std. C95.1-1992 and has
been tested in accordance with the measurement procedures specified in FCC/OET
Bulletin 65 Supplement C (2001) and IEEE Std. 1528-200X (Draft 6.5, January 2002).
RF Exposure: For body worn operation, to maintain compliance with FCC RF exposure
guidelines, use only accessories that contain no metallic components and provide a
separation distance of 15mm (0.6 inches) to the body. Use of other accessories may
violate FCC RF exposure guidelines and should be avoided.
The FCC requires the user to be notified that any changes or modifications to this device
that are not expressly approved by Nonin Medical, Inc. may void the user’s authority to
operate the equipment.
NOTE: No modifications to this device are allowed that in any way affect or alter
its antenna or antenna configuration.
