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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 9560, 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.
• 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:
• Reorient or relocate the receiving antenna.
• Increase the distance between the equipment and the receiver.
• Connect the equipment 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 and provide a separation distance of 15 mm (0.6 inches) to the
body. Use of other accessories may violate FCC RF exposure guidelines and should be avoided.
• The Model 9560 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 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. C95.1-2005 and has been tested in accordance with the
measurement procedures specified in FCC/OET Bulletin 65 Supplement C (2001) and IEEE Std. 1528-2003.
• 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.
A Guide to Symbols
Symbol
Definition of Symbol
Follow Instructions for Use.
Consult Instructions for Use
!
Caution!
Type BF Applied Part (patient isolation from electrical shock)
UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical
hazards only in accordance with IEC 60601-1, UL 60601-1 and CAN/CSA-C22.2 No. 601.1.
0123
CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices
Radio Equipment Class Identifier
Serial Number
Battery Orientation
Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may
occur in the vicinity of equipment marked with this symbol.
Indicates separate collection for electrical and electronic equipment (WEEE).
SN
