User's Manual

Radical-7 Safety Information, Warnings, and Cautions
www.masimo.com 17 Masimo
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.
Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) 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 in any manner inconsistent with the instructions for use or labeling.
Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
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.
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 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 different from that to which the
receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
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.
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.
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 B. These limits are
designed to provide reasonable protection against harmful interference in a typical medical
installation.
This Class B digital apparatus complies with Canadian ICES-003.