Root Safety Information, Warnings, and Cautions
www.masimo.com 13 Masimo
Compliance Information, Warnings and Cautions
WARNING: In accordance with international telecommunication
requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for
indoor usage to reduce potential for harmful interference to co-channel
mobile satellite systems.
CAUTION: Disposal of product: Comply with local laws in the disposal of the
instrument and/or its accessories.
Note: Cleared Use Only: The device and related accessories are cleared by
the Food and Drug Administration (FDA) and are CE Marked for noninvasive
patient monitoring and may not be used for any processes, procedures,
experiments or any other use for which the device is not intended or cleared
by the FDA or other applicable regulatory authorities, or in any manner
inconsistent with the instructions for use or labeling.
Note: 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
when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this equipment in
a residential area is likely to cause harmful interference in which case the
user will be required to correct the interference at his own expense.
In order to maintain compliance with FCC regulations, shielded cables must
be used with this equipment. Operation with non-approved equipment or
unshielded cables is likely to result in interference to radio and TV reception.
The user is cautioned that changes and modifications made to the equipment
without the approval of manufacturer could void the user's authority to
operate this equipment.
Note: This equipment has been tested and found to comply with the limits for
medical devices to the EN 60601-1-2: 2002, Medical Device Directive
93/42/EEC and Class A. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation.
Note: To satisfy RF exposure requirements, this device and its antenna must
operate with a separation distance of at least 20 cm from all persons and
must not be co-located or operating in conjunction with any other antenna or
transmitter.
Note: This device 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.
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