Masimo Root Manual page 3

Not for Sale in the USA - For Export Only
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 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: Use of this device must follow the order of a physician.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
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
Authorized Brazil Company Representative:
MEDSTAR IMPORT AND EXPORT EIRELI
R VALENCIO SOARES RODRIGUES, 89- ROOM 1
CEP: 06.730-000
NEIGHBORHOOD: CENTER
MUNICIPALITY: VARGEM GRANDE PAULISTA
UF: SP
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1, and applicable Particular
(IEC 60601-2-49, IEC 80601-2-30, ISO 80601-2-56) and related Collateral (IEC
3149433
60601-1-8:2006) Standards for which the product has been found to comply by
Patents: www.masimo.com/patents
®, Masimo®, MOC-9®, Radical-7®, Radius-7®, rainbow®, Root®, SedLine®, SET®, and
Signal Extraction Technology® are federally registered trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
www.masimo.com
MEDICAL ELECTRICAL EQUIPMENT
IN ACCORDANCE WITH
Intertek.
1 Masimo