Masimo Root Operator's Manual page 3

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:VKF-RDS7A IC:7362A-RDS7A IC Model: RDS7A
Masimo Corporation
52 Discovery
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
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
Conforms to ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1, and applicable
3149433
Particular (IEC 60601-2-49, IEC 80601-2-30, ISO 80601-2-56) and related Collateral (IEC
60601-1-8:2006) Standards for which the product has been found to comply by Intertek.
Patents: www.masimo.com/patents
, Iris, Masimo, MOC-9, PVi, Radical-7, Radius-7, rainbow, Root, RRa, SedLine, SET, Signal Extraction
Technology, SpCO, SpHb, and SpMet are federally registered trademarks of Masimo Corporation.
ISA, MyView, 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.
© 2018 Masimo Corporation
www.masimo.com
MEDICAL ELECTRICAL EQUIPMENT
ACCORDANCE WITH
1 Masimo