Masimo Root User manual

Addendum
Root®
with Pathway

www.masimo.com 1 Masimo
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.: [phone]
Fax.: [phone]
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
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
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
60601-1-8:2006) Standards for which the product has been found to comply by
Intertek.
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 2 Masimo
© 2019 Masimo Corporation

www.masimo.com 3 Masimo
Contents
Addendum, Root Operator's Manual: Root with Pathway-------------------------------------------- 5
Product Description, Features and Indications for Use------------------------------------------------7
Key Feature Update--------------------------------------------------------------------------------------7
Safety Information, Warnings, and Cautions----------------------------------------------------------- 9
Performance Warnings and Cautions---------------------------------------------------------------- 9
Operation---------------------------------------------------------------------------------------------------- 11
Accessing Main Menu Options for Pathway ------------------------------------------------------- 11
Pathway Settings--------------------------------------------------------------------------------------- 12
Device Settings-----------------------------------------------------------------------------------------15
Pathway------------------------------------------------------------------------------------------------------ 19
About the Pathway Main Screen -------------------------------------------------------------------- 19
Pathway Procedure------------------------------------------------------------------------------------- 21
Messages ----------------------------------------------------------------------------------------------------29
Troubleshooting-------------------------------------------------------------------------------------------- 31
Root Troubleshooting --------------------------------------------------------------------------------- 31

www.masimo.com 5 Masimo
Addendum, Root Operator's Manual:
Root with Pathway
This addendum provides updates to the following:
Operator's Manual, Root®
•37365/LAB-8425 and equivalent translations
•37503/LAB-8542 and equivalent translations
Operator's Manual, Root® with noninvasive blood pressure and temperature
•37705/LAB-8747 and equivalent translations
•38280/LAB-9274 and equivalent translations
This addendum covers the Pathway feature of the Root device. For all other information, refer
to the Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood
pressure and temperature.

www.masimo.com 7 Masimo
Product Description, Features and
Indications for Use
The following information is an addendum to be used with the content in Product
Description, Features and Indications for Use of the Operator's Manual, Root® or Operator's
Manual, Root® with noninvasive blood pressure and temperature.
Key Feature Update
The following added feature is available for Root:
•Pathway is an optional continuous monitoring mode which allows clinicians to set
a visual indicator of the preferred oxygen saturation range during the first 10
minutes after birth.