Operator's Manual
www.masimo.com 1 Masimo
For Sale in the USA
These operating instructions provide the necessary information for proper
operation of all models of the Root®. There may be information provided in
this manual that is not relevant for your system. General knowledge of pulse
oximetry and an understanding of the features and functions of Root are
prerequisites for its proper use. Do not operate Root without completely
reading and understanding these instructions. If you encounter any serious
incident with product, please notify the competent authority in your country
and the manufacturer.
Notice: Purchase or possession of this device does not carry any express or
implied license to use with replacement parts which would, alone or in
combination with this device, fall within the scope of one of the relating
patents.
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 applicable regulatory authorities, or in any manner
inconsistent with the directions for use or labeling.
CAUTION: Federal (USA) law restricts this device to sale by or on the order
of a physician. See instructions for use for full prescribing information,
including indications, contraindications, warnings and precautions.
Wireless Radio:
Contains: FCC ID: VKF-MWM2 | Model: RDS-7A or RDS-7 | IC: 7362A-MWM2