Compliance Warnings And Cautions - Masimo Root Operator's Manual

Root NIBPT

Compliance Warnings and Cautions

WARNING: Changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user's authority to operate the equipment.
WARNING: Do not incinerate the battery.
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: Consideration to the compliance of the IEC 60601-1-1 standard should be made
when configuring Root as part of a Medical System.
CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its
accessories.
Note: Use Root in accordance with the Environmental Specifications section in the
Operator's Manual.
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.
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. If this equipment does cause harmful interference to
radio or television, 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.
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 equipment has been tested and found to comply with the Class A limits for
medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful interference in a
hospital environment.
Note: This Class A digital apparatus complies with Canadian ICES-003.
Note: Root is not intended for use during patient transport outside the healthcare facility.
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Safety Information, Warnings, and Cautions
19 Masimo