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1990) (Amd. 2-1995) (Corrigendum-1995) IEC 60601-1-2 Issued: 2004/11/01
Ed: 2.1 Medical Electrical Equipment Part 1-2: General
Requirements for Safety - Collateral Standard: Electromagnetic Compatibility
Requirements and Tests-Edition 2.1; Consolidated Reprint
16. Regulatory Statement*
*Las siguientes secciones están en inglés para mantener su significado
original). TF Health Corporation, dba Breezing Co. (hereafter "Breezing Co."),
1761W. University Dr. Suite 140, Tempe, AZ 85281, USA, declares under its
sole responsibility that Breezing® complies with the following standards: IEC
60601-1-2:2007, EN 60601-1-2:2007, Class B for Emissions, and Immunity for
not Life-Supporting Equipment. Operation is subjected 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. This equipment has been tested and found to
comply with the limits for a Class B. 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 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 separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit separate from the receiver.
• Consult the dealer or an experienced radio/TV technician for help.
CAUTION: Changes or modifications to this equipment not expressly approved
by the party responsible for compliance could void the user's authority to
operate the equipment. This product is a Class B complying with the specified
requirements of the Standard to provide protection against electric shock,
particularly regarding allowable Leakage Current.
17.
Copyright, Patent and Trademark Notice
Breezing® and/or some of its components and features are covered by one or
more pending patent applications. The Breezing Mobile App, the software and
firmware stored on the Breezing® and the Breezing database (individually and
collectively, the "Breezing Materials") are protected by copyright law and/or
trade secret law and may not be copied, reproduced, modified, published,
distributed, transmitted, transferred, used to create derivative works or
otherwise used without the expressed written permission of Breezing Co.
Breezing® and logo, and other trademarks and/or names are trademarks or
service marks of Breezing Co. Breezing Co.'s trademarks may not be used in
connection with any product or service that is not Breezing Co.'s, in any manner
that is likely to cause confusion among the general public, or in any manner that
disparages or discredits Breezing Co. or its affiliates. The absence of a
trademark, trade name or service mark from the above list does not constitute a
waiver of Breezing Co.'s intellectual property rights concerning that trademark,
trade name or service mark.
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