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Indications for Use
Declaration of Conformity with FCC and Canadian Ministry of
Health Rules for Electromagnetic Compatibility
• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares
under its sole responsibility that Model 3150, WristOx
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Pulse Oximeter, to which this
declaration relates, complies 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.
• 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 1.6 W/kg.
Federal Communications Commission (FCC) Notice
This device 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 device 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 device off and on. The user is encouraged to try to correct
the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the distance between the device and the receiver.
• Connect the device to an outlet on a circuit different from the outlet where the receiver
is connected
• Consult the dealer or an experienced radio/TV technician for assistance.
• RF Exposure: For body worn operation, to maintain compliance with FCC RF exposure
guidelines, use only accessories that contain no metallic components. Use of other
accessories may violate FCC RF exposure guidelines and should be avoided.
• The WristOx
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, Model 3150, is designed and manufactured not to exceed the emission
limits for exposure to radio frequency (RF) energy set by the United States FCC. 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 device has been shown to be
compliant for localized specific absorption rate (SAR) for uncontrolled environment/
general population exposure limits specified in ANSI/IEEE Std. C95.1-2005.
• 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 device.
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