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.
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
FCC ID:VFK-RDS7A IC:7362A-RDS7A IC Model: RDS-7A
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Medical electrical equipment with respect to electric shock, fire, and
mechanical hazards only in accordance with
UL 60601-1/CAN/CSA C22.2 No. 601.1
Patents: www.masimo.com/patents.htm
PVi, Radical-7, rainbow, Root, RRa, SedLine, SET, Signal Extraction Technology, SpCO, SpHb,
SpMet, Masimo and , are federally registered trademarks of Masimo Corporation.
Iris, ISA, MOC-9, MyView, Radius-7 and SpOC are trademarks of Masimo Corporation.
The use of the trademark Patient SafetyNet is under license from University HealthSystem
Consortium.
All other trademarks and registered trademarks are property of their respective owners.
© 2017 Masimo Corporation
