Masimo Root User manual

Addendum
Root®
with Pathway

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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.

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© 2019 Masimo Corporation

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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

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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.

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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.

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Safety Information, Warnings, and
Cautions
The following information is an addendum to be used with the content in Safety Information,
Warnings and Cautions of the Operator's Manual, Root® or Operator's Manual, Root® with
noninvasive blood pressure and temperature.
CAUTION: Before using Pathway on Root, completely read and understand the Operator's
Manual, Radical-7, Operator's Manual, Root® or Operator's Manual, Root® with noninvasive
blood pressure and temperature. This addendum to the Operator's Manual provides specific
instructions about using Pathway.
Performance Warnings and Cautions
Pathway
WARNING: Monitoring in the Pathway mode is not intended to direct or prescribe a clinical
treatment or therapy decision. The clinical treatment and therapy decision should be
evaluated in conjunction with the patient’s clinical status and confirmed with additional
diagnostic tests consistent with each hospital’s policy. Any concern about a patient’s clinical
condition should prompt an urgent clinical review, irrespective of monitoring results.
WARNING: Visual indicator of the glide path should be adjusted according to the hospital’s
policy and should not be used as the sole basis for medical decisions. It must be used in
conjunction with clinical signs and symptoms.
Note: The time scrub button should be adjusted to reflect the actual elapsed time. The
default time indicated is based upon the elapsed time from the start of use of the mode.

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Operation
The following information is an addendum to be used with the content in Chapter 3:
Operation of the Operator's Manual, Radical-7, Operator's Manual, Root® or Operator's
Manual, Root® with noninvasive blood pressure and temperature.
Accessing Main Menu Options for Pathway
To access the Pathway Main Menu options, press the Main Menu icon at the bottom right
corner of the touchscreen:
The Main Menu options include Root specific settings as well as Root settings.
Options in the Main Menu include the following:
Pathway Settings
See Pathway Settings on page 12.
Sounds*
Device Settings
See Device Settings.
About*
* For Root settings not related to Pathway, refer to Chapter 3: Operation of the Operator's
Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and
temperature.

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Pathway Settings
Pathway settings include the following:
Parameter Settings*, **
See Parameter Settings on page 12.
Additional Settings
See Additional Settings on page 13.
SpO2 Pathway Alarms**
See SpO2 Pathway Alarms on page 13.
SpO2 Target Range
See SpO2 Target Range on page 14.
PR Threshold
See PR Threshold on page 15.
* Only displays when Radical-7 is docked to Root.
** The SpO2 Pathway Alarms control the alarm limits during the first 10 minutes of Pathway
operation. After 10 minutes of Pathway operation, the SpO2 Parameter Settings control the
alarm limits.
Parameter Settings
Parameter Settings display only when Radical-7 is docked to Root.
Note: The Neonatal profile is selected by default for all Radical-7 parameter settings during
Pathway operation.
For information about configuring the Parameter Settings related to Pathway, refer to Chapter
3: Operation of the Operator's Manual, Radical-7 Pulse CO-Oximeter.

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Additional Settings
From the Additional Settings screen, change any of the following options:
Option Description Factory Default
Settings
User Configurable
Settings
SmartTone Allows the audible pulse to continue to
beep when the pleth graph shows signs
of motion.
Off On or Off
SpO2 Pathway Alarms
The SpO2 Pathway Alarms allow the user to optionally adjust alarm limits during the first 10
minutes when used in Pathway mode. After 10 minutes, the alarm limits revert to the ones
set as part of the SpO2 Parameter Settings.
From the SpO2Pathway Alarms settings screen, change any of the following options:
Options Description Factory Default
Settings
User Configurable
Settings
High
Limit High Limit is the upper threshold that triggers an alarm. 99 2 to 99 in steps of 1, or Off
Low Limit Low Limit is the lower threshold that
triggers an alarm. 88 1 to 98 in steps of 1
Silence
Duration Sets the amount of time that the alarm is silenced. 2 minutes 30 seconds, 1 or 2 minutes
Rapid
Desat Sets the Rapid Desat limit threshold to the selected amount below the Low Alarm
Limit. When SpO2value falls below rapid
desat limit the audio and visual alarm are
immediately triggered without respect to
the alarm delay.
-10 Off, -5, or -10

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Options Description Factory Default
Settings
User Configurable
Settings
Alarm
Delay When an alarm condition is met, this feature delays the audible part of an
alarm.
10 0, 5, 10, or 15
SpO2 Target Range
Use the SpO2 Target Range settings screen to configure the Glide Path visualization. See
Pathway Screen on page 20.
Option Description Factory Default Settings* User Configurable Settings**
1 Min
SpO2Max 60 60 to 98 in steps of 1
SpO2Min 65 61 to 99 in steps of 5
2 Min
SpO2Max 65 60 to 98 in steps of 1
SpO2Min 70 61 to 99 in steps of 1
3 Min
SpO2Max 70 60 to 98 in steps of 1
SpO2-axis Min 75 61 to 99 in steps of 1
4 Min
SpO2Max 75 60 to 98 in steps of 1
SpO2Min 80 61 to 99 in steps of 1
5 Min
SpO2Max 80 60 to 98 in steps of 1
SpO2Min 85 61 to 99 in steps of 1
10 Min
SpO2Max 85 60 to 98 in steps of 1
SpO2-axis Min 95 61 to 99 in steps of 1
* Default settings are established based upon the recommendation made by Wyckoff MH, Aziz
K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin, JG.
Part 13: neonatal resuscitation: 2015 American Heart Association Guidelines Update for

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Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation.
2015;132(suppl 2):S543–S560.
** Visual indicators only. Audible alarms only occur when the Radical-7 high and low alarm
limits are reached. Refer to the Operator's Manual, Radical-7® Pulse CO-Oximeter®.
PR Threshold
From the PR Threshold settings screen, change any of the following options. Default settings
are established based upon the recommendation made by the International Liaison
Committee on Resuscitation (ILCOR).
Options Description Factory Default
Settings*
User Configurable
Settings**
Low Limit Adjusts the low limit threshold
visual indicator. 100 35 to 235 in steps of 5
Critical
Limit Adjusts the critical limit threshold visual indicator. 60 30 to 230 in steps of 5
* Default settings are established based upon the recommendation made by Wyckoff MH, Aziz
K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin, JG.
Part 13: neonatal resuscitation: 2015 American Heart Association Guidelines Update for
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation.
2015;132(suppl 2):S543–S560.
** Visual indicator only. Audible alarms only occur when the Radical-7 high and low alarm
limits are reached. Refer to the Operator's Manual, Radical-7® Pulse CO-Oximeter®.
Device Settings
On Root equipped with Pathway, some Device Settings options change and are reflected
below:
Access Control
See Access Control on page 16.

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Access Control
Access Control contains configurable options and settings that require a password.
To enter Access Control
1. Press the key.
2. When the numeric screen displays, enter the following numbers: 6 2 7 4
Asterisks (****) will be displayed.
To undo an entry, press Backspace.
3. Press Enter to access the password protected screen.
Note: The password will have to be entered every time this screen is accessed.
Option Description Factory Default
Setting
Configurable Settings
All Mute
Enabled
Enables or disables
parameter Alarm
Silence menu option.
See Sounds.
Off On or Off
Lock Alarm
Volume Sets the lowest alarm volume level. Off 3, 4, or Off
USB Port 1*
baud rate
Enables option to
change baud rate of
device. 921600 9600, 19200, 38400,
57600, 115200,
230400, or 921600
USB Port 2*
baud rate
Enables option to
change baud rate of
device. 921600 9600, 19200, 38400,
57600, 115200,
230400, or 921600
Data
Collection
Enabled
Enables or disables
physical data
collection mode. Off On or Off

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Option Description Factory Default
Setting
Configurable Settings
Factory
Defaults Options are restored to factory value. N/A Press Restore.
*Changes to USB Ports baud rate will take effect after Root is power cycled (turned off then on
again).
Note: Restore Factory Defaults can only be performed during non-monitoring and when no
cable connections are present.