Operator's Manual

Rad-97 Safety Information, Warnings and Cautions
www.masimo.com 22 Masimo
CAUTION: Do not submerge the Rad-97 in any cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously
damage the device.
CAUTION: To prevent damage, do not soak or immerse Rad-97 in any liquid solution.
CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of
patient-applied circuits and the system are within acceptable limits as specified by the
applicable safety standards. The summation of leakage currents must be checked and in
compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked
when connecting external equipment to the system. When an event such as a component
drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest
before further use. Injury to personnel could occur.
NomoLine Capnography
WARNING: Do not apply negative pressure to remove condensed water from the NomoLine
Family sampling line.
WARNING: Do not sterilize or immerse NomoLine sampling lines in liquid.
Compliance Warnings and Cautions
WARNING: Any 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: 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.
WARNING: Users are advised that high-power radars are allocated as primary users (i.e.
priority users) of the bands 5.25-5.35 GHz and 5.65-5.85 GHz and that these radars could
cause interference and/or damage to LE-LAN devices.
CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its
accessories.
CAUTION: Device contains an internal battery. Dispose of the battery according to required
country or regional requirements.
Note: Use Rad-97 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 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: