Masimo Root User manual

Operator's Manual
Root®

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.: [phone]
Fax.: [phone]
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

www.masimo.com 3 Masimo
Contents
About This Manual-------------------------------------------------------------------------------------------7
Product Description and Features, Intended Use and Indications for Use ----------------------- 9
Product Description and Features-------------------------------------------------------------------- 9
Intended Use -------------------------------------------------------------------------------------------- 9
Indications for Use-------------------------------------------------------------------------------------- 9
Contraindication ---------------------------------------------------------------------------------------10
Safety Information, Warnings, and Cautions---------------------------------------------------------- 11
Safety Warnings and Cautions----------------------------------------------------------------------- 11
Performance Warnings and Cautions--------------------------------------------------------------- 12
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 14
Compliance Warnings and Cautions---------------------------------------------------------------- 14
Chapter 1: Description ------------------------------------------------------------------------------------ 17
Features-------------------------------------------------------------------------------------------------- 17
Chapter 2: Setting Up------------------------------------------------------------------------------------- 21
Unpacking and Inspection --------------------------------------------------------------------------- 21
Guidelines for Setting Up----------------------------------------------------------------------------- 21
Power On ------------------------------------------------------------------------------------------------22
Initial Battery Charging -------------------------------------------------------------------------------23
Radical-7 Connection----------------------------------------------------------------------------------24
Radius-7 Connection-----------------------------------------------------------------------------------25
MOC-9 Connection-------------------------------------------------------------------------------------25
Nurse Call Connection --------------------------------------------------------------------------------26
Chapter 3: Operation-------------------------------------------------------------------------------------- 27
About the Main Screen-------------------------------------------------------------------------------- 27
About the Status Bar ----------------------------------------------------------------------------------28
About the Action Bar ---------------------------------------------------------------------------------- 31
Using the Touchscreen Interface--------------------------------------------------------------------32
Menu Navigation-------------------------------------------------------------------------------------- 35
Understanding Windows----------------------------------------------------------------------------- 36
Accessing Main Menu Options-----------------------------------------------------------------------43
Alarm Interface---------------------------------------------------------------------------------------- 60

Root Contents
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Trend Download----------------------------------------------------------------------------------------65
Session Management ---------------------------------------------------------------------------------65
Screenshot Capture------------------------------------------------------------------------------------65
Lights ---------------------------------------------------------------------------------------------------- 67
Chapter 4: Admit and Discharge to Patient SafetyNet---------------------------------------------- 71
Not Admitted ------------------------------------------------------------------------------------------- 71
Admitting a Patient ----------------------------------------------------------------------------------- 72
Discharging a Patient --------------------------------------------------------------------------------- 73
Not Monitoring Message ----------------------------------------------------------------------------- 74
Monitoring Resumed Message----------------------------------------------------------------------- 75
Electronic Medical Record (EMR) Push ------------------------------------------------------------ 75
Chapter 5: Radius-7 --------------------------------------------------------------------------------------- 79
Chapter 6: MOC-9 ----------------------------------------------------------------------------------------- 81
Using MOC-9 Ports ------------------------------------------------------------------------------------ 81
Chapter 7: Iris ----------------------------------------------------------------------------------------------83
Iris Status Screen --------------------------------------------------------------------------------------84
Using Iris Connectivity Ports ------------------------------------------------------------------------85
Chapter 8: Messages-------------------------------------------------------------------------------------- 87
Chapter 9: Troubleshooting -----------------------------------------------------------------------------89
Troubleshooting Radical-7, Radius-7, and MOC-9 Modules-------------------------------------89
Troubleshooting Root ---------------------------------------------------------------------------------89
Chapter 10: Specifications------------------------------------------------------------------------------- 91
Alarms --------------------------------------------------------------------------------------------------- 91
Nurse Call Specifications ----------------------------------------------------------------------------- 91
Connectors ---------------------------------------------------------------------------------------------- 91
Electrical-------------------------------------------------------------------------------------------------92
Environmental------------------------------------------------------------------------------------------92
Touchscreen Display-----------------------------------------------------------------------------------93
Wireless Specifications -------------------------------------------------------------------------------93
Compliance ---------------------------------------------------------------------------------------------95
Guidance and Manufacturer's Declaration-Electromagnetic Emissions----------------------96
Guidance and Manufacturer's Declaration-Electromagnetic Immunity ---------------------- 97
Recommended Separation Distances --------------------------------------------------------------99

Root Contents
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Symbols------------------------------------------------------------------------------------------------100
Chapter 11: Service and Maintenance---------------------------------------------------------------- 103
Cleaning ----------------------------------------------------------------------------------------------- 103
Replacing the Fuses --------------------------------------------------------------------------------- 103
Power-On Self Test----------------------------------------------------------------------------------- 104
Nurse Call Setting Connections ------------------------------------------------------------------- 104
Battery Test ------------------------------------------------------------------------------------------- 105
Repair Policy ------------------------------------------------------------------------------------------ 105
Return Procedure------------------------------------------------------------------------------------- 105
Contacting Masimo ---------------------------------------------------------------------------------- 106
Index ------------------------------------------------------------------------------------------------------- 109

www.masimo.com 7 Masimo
About This Manual
This manual explains how to set up and use Root®. Important safety information relating to
general use of Root appears in this manual. Read and follow any warnings, cautions, and
notes presented throughout this manual. The following are explanations of warnings,
cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.

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Product Description and Features,
Intended Use and Indications for Use
Product Description and Features
Root®is a patient monitoring and connectivity platform. It offers multiple high-impact
innovations for broad applications across the continuum of care.
•Instantly interpretable, high-visibility display of Masimo’s breakthrough SET®and
rainbow®SET measurements.
•Intuitive, touchscreen navigation for easy and adaptable use in any hospital
environment.
•Flexible measurement expansion through Masimo Open Connect (MOC-9™).
•Designed for third-party measurement expansion to allow other companies to add
to the platform measurements.
•Built-in network connectivity gateway through Iris™ for standalone devices such as
IV pumps, ventilators, beds, and other patient monitors.
•Docking and charging station for Radical-7®and Radius-7®Battery Module.
•Ability to display data on a secondary display.
For all prescribing information and instructions for use of the compatible medical devices
that are connected to Root, see Operator’s Manual or Instructions for Use for the specific
medical device.
Intended Use
The Masimo Root Monitoring System is indicated for use by healthcare professionals for the
monitoring of multiple physiological parameters in healthcare environments.
The Masimo Root Monitoring System can transmit data for supplemental remote viewing and
alarming (e.g., at a central station).
The Masimo Root Monitoring System can be used with the optional Radical-7, ISA product
family, Radius-7, and/or the SedLine module.
The Masimo Root Monitoring System is intended to be used with connected measurement
modules compatible with Root interfaces.
Indications for Use
The Masimo Root Monitoring System is indicated for use by healthcare professionals for the
monitoring of multiple physiological parameters in healthcare environments.
The Masimo Root Monitoring System can transmit data for supplemental remote viewing and
alarming (e.g., at a central station).
The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the
continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation
(SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo

Root Product Description and Features, Intended Use and Indications for Use
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Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and
neonatal patients during both no motion and motion conditions, and for patients who are
well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide
the continuous noninvasive monitoring data obtained from the Masimo Radical-7 Pulse
CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate to multi-parameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for
the continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin
saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).
The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with
adult and pediatric patients during both no motion and motion conditions, and for patients
who are well or poorly perfused in hospitals and hospital-type facilities.
The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2,
ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for
monitoring of breath rate and the following breathing gases:
ISA CO2: CO2
ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for
monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The
intended environment is the operating suite, intensive care unit and patient room. ISA CO2is
also intended to be used in road ambulances. The intended patient population is adult,
pediatric and infant patients.
The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR),
intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state
of the brain by real-time data acquisition and processing of EEG signals. The system includes
the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect
of anesthetic agents
Contraindication
None.

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Safety Information, Warnings, and
Cautions
CAUTION: Root is to be operated by, or under the supervision of, qualified personnel only. The
manual, accessories, directions for use, all precautionary information, and specifications
should be read before use. Refer to Operator's Manuals for ISA, Kite, Patient SafetyNet,
Radical-7, Radius-7, and SedLine for additional safety information, warnings, and cautions.
Safety Warnings and Cautions
WARNING: Do not use Root if it appears or is suspected to be damaged.
WARNING: Do not adjust, repair, open, disassemble or modify Root. Injury to personnel or
equipment damage could occur. Return Root for servicing.
WARNING: Do not use Root during or nearby magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Do not place Root or accessories in any position that might cause it to fall on the
patient.
WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the
device during operation.
WARNING: Do not use Root in the presence of flammable anesthetics or other flammable
substance in combination with air, oxygen-enriched environments or nitrous oxide to avoid
risk of explosion.
WARNING: To reduce the risk of explosion, only replace battery with Masimo supplied parts.
WARNING: Do not start or operate the Root unless the setup was verified to be correct.
WARNING: To ensure safety, only use Masimo authorized devices with Root.
WARNING: To protect against fire hazard, replace only with recommended fuses of the same
type, current rating, and voltage rating.
WARNING: Do not remove the back panel of the device. This could cause injury to personnel
or device damage.
WARNING: Electrical Shock Hazard: To protect against injury, follow the directions below:
•Avoid placing the device on surfaces with visible liquid spills.
•Do not soak or immerse the device in liquids.
•Do not attempt to sterilize the device.
•Use cleaning solutions only as instructed in this Operator's Manual.
•Do not attempt to clean the Root while monitoring patient.
WARNING: Do not plug in or remove the power cord with wet hands to avoid risk of electric
shock. Ensure that your hands are clean and dry before touching the power cord.
WARNING: When positioned on a flat surface, the device should be secured with a mounting
system recommended by Masimo.
WARNING: As with all medical equipment, carefully route patient cables to reduce the
possibility of patient entanglement or strangulation.

Root Safety Information, Warnings, and Cautions
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CAUTION: Do not place the Root where the controls can be changed by the patient.
CAUTION: To ensure patient isolation, connect only Masimo devices that have been designed
for Root.
CAUTION: Equipment intended to be connected to signal input/signal output ports should
comply with applicable electrical safety standards to further minimize the risk of electric
shock. Only devices that have been configured to operate with Root may function properly
when connected.
CAUTION: Only use the AC power cable provided by Masimo. Using a different AC power cable
could cause damage to Root. Check the power cord and plug to ensure that it is intact and
undamaged.
CAUTION: To avoid risk of electrical shock, this equipment must only be connected to a
supply mains with a protective earth connection. Do not under any circumstances remove the
grounding conductor from the power plug.
CAUTION: Use a grounded outlet for proper equipment grounding. A hospital-grade outlet is
required.
CAUTION: Do not place Root where the appliance inlet or the AC power plug cannot be
readily disconnected.
Note: Disconnect the device from AC mains by removing the AC power cord connector from
the device inlet.
Note: If there is any doubt about the integrity of the protective earth conductor arrangement,
operate Root on internal battery power until the AC power supply protective conductor is fully
functional.
Note: Do not monitor more than a single patient at a time on Root.
Note: It is recommended that Root is attached to an AC power source when it is not in use to
ensure that the battery remains fully charged.
Note: For medical technologies that require AC power, the battery should be adequately
charged to ensure backup power in case of AC power disruption.
Performance Warnings and Cautions
WARNING: Root should not be used as the sole basis for medical decisions. It must be used in
conjunction with clinical signs and symptoms.
WARNING: Root may be used during defibrillation. This may affect the accuracy or
availability of the parameters and measurements.
WARNING: Root may be used during electrocautery. This may affect the accuracy or
availability of the parameters and measurements.
WARNING: Wireless communication of alarms to a secondary monitoring station should not
be relied upon as a primary alarm.
WARNING: Do not place the Root against a surface that may cause the alarm to be muffled.
WARNING: Radical-7 may not fully charge in a high ambient temperature environment.
WARNING: Always ensure settings including alarms are appropriate for each patient prior to
use.

Root Safety Information, Warnings, and Cautions
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WARNING: When using multiple devices in the same or similar environment, use of the same
patient profile (including the same alarm presets) to avoid confusion that can lead to patient
harm.
CAUTION: Ensure the speaker is not covered.
CAUTION: Before using Root under high intensity surgical lights, confirm that the display
settings allow for clear display of measurements.
CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer.
CAUTION: Do not place the Root on electrical equipment that may affect the device,
preventing it from working properly.
CAUTION: Failure to charge Root promptly after a Low Battery alarm may result in the device
shutting down.
CAUTION: To minimize radio interference, other electrical equipment that emits radio
frequency transmissions should not be in close proximity to Root.
CAUTION: If the Radical-7 or Radius-7 stops communicating with Root, parameters and
measurements will not show on the Root; however, this will not affect Radical-7's or
Radius-7's ability to monitor the patient.
CAUTION: In order to establish and maintain Root’s minimum Quality of Service, the
following network specifications should be met before and after installation:
•Wired Network Connection
During Ping Test, passing result if:
a. At least 98% of packets have latency ≤ 30 milliseconds, and
b. No more than 2 % packets loss.
•Wireless Network Connection
During Ping Test, passing result if:
a. At least 98% of packets have latency ≤ 100 milliseconds,
b. No more than 2 % packets loss, and
c. Primary access point signal strength at least -67 dBm.
CAUTION: The wireless quality of services may be influenced by the presence of other devices
that may create radio frequency interference (RFI). Some RFI devices to consider are as
follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID,
MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices,
consideration should be taken to maximize separation distances and to observe for any
potential signs of interference such as loss of communication or reduced Wi-Fi signal
strength.
Note: Root is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication.
Note: Root’s alarm capabilities have been designed to be independent of the Wi-Fi
communication feature in order to preserve Root’s primary alarms.

Root Safety Information, Warnings, and Cautions
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Kite
WARNING: When using Root the Kite accessory does not generate or manage alarms. The
Root alarms, used in conjunction with clinical signs and symptoms, are the primary sources
for determining that an alarm condition exists.
CAUTION: Kite is not a primary display. Medical decisions should be made using data from
the primary display of a device in conjunction with clinical signs and symptoms.
Patient SafetyNet System
Note: The wireless communication status between Root and Patient SafetyNet is displayed
by Patient SafetyNet.
Cleaning and Service Warnings and Cautions
WARNING: Electrical Shock Hazard: The Root battery should be installed and/or removed
from Root only by qualified personnel.
WARNING: Do not use petroleum-based or acetone solutions, or other harsh solvents, to
clean the Root. These substances affect the device’s materials and device failure can result.
CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds,
instruments, brushes, rough-surface materials, or bring them into contact with anything that
could scratch the display.
CAUTION: Do not submerge the Root in any cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously
damage the device.
CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the
device and disconnect from any AC power source.
CAUTION: An operator may only perform maintenance procedures specifically described in
the manual. Refer servicing to qualified service personnel trained in the repair of this
equipment.
CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of
patient-applied circuits and the system are within acceptable limits as specified by the
applicable safety standards. The summation of leakage currents must be checked and in
compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked
when connecting external equipment to the system. When an event such as a component
drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest
before further use. Injury to personnel could occur.
Note: Excessive cleaning solution can flow into the device and cause damage to internal
components.
Compliance Warnings and Cautions
WARNING: Changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user’s authority to operate the equipment.
WARNING: Do not incinerate the battery.

Root Safety Information, Warnings, and Cautions
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WARNING: In accordance with international telecommunication requirements, the frequency
band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful
interference to co-channel mobile satellite systems.
CAUTION: Consideration to the compliance of the IEC 60601-1-1 standard should be made
when configuring Root as part of a Medical System.
CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its
accessories.
Note: Use Root in accordance with the Environmental Specifications section in the
Operator's Manual.
Note: This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause
undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class A
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be required to correct
the interference at his own expense.
In order to maintain compliance with FCC regulations, shielded cables must be used with this
equipment. Operation with non-approved equipment or unshielded cables is likely to result in
interference to radio and TV reception. If this equipment does cause harmful interference to
radio or television, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.
Note: To satisfy RF exposure requirements, this device and its antenna must operate with a
separation distance of at least 20 cm from all persons and must not be co-located or
operating in conjunction with any other antenna or transmitter.
Note: This equipment has been tested and found to comply with the Class A limits for
medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful interference in a
hospital environment.
Note: This Class A digital apparatus complies with Canadian ICES-003.
Note: Root is not intended for use during patient transport outside the healthcare facility.

www.masimo.com 17 Masimo
Chapter 1: Description
Root can be used in the following ways:
•As a docking station and charger for Radical-7 and Radius-7 Battery Module.
•As a bedside monitoring display for parameters on Radical-7, Radius-7, and MOC-9
modules.
•As a connectivity gateway for standalone devices.
Features
Front View
Ref. Feature Description
1Docking Station
Provides a docking station for the Radical-7 and Radius-7 (Note:
Battery Charging Adapter required for Radius-7). While docked, the
Radical-7 can communicate monitored parameters and
measurements.*
2Root Display and
Touchscreen Provides a frontal display and interface for user interactions.
3Home Button Provides access to the Main Screen.
4Root Charging
Indicator Shows an indication of the battery charge for Root.

Root Chapter 1: Description
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Ref. Feature Description
5AC Power
Indicator Shows an indication of AC power connection Root.
6Radical-7 Charging
Indicator
Shows an indication of battery charge for the Radical-7 in the
Docking Station.
*Only the touchscreen version of the Radical-7 is able to communicate monitored parameters
and measurements. All other versions can only charge in the docking station but not
communicate with Root.
Back View
Ref. Feature Description
1Handle Allows the user to transport Root.
2Speaker Provides audible notification.
3Nurse Call
Connector Provides a connection to a Nurse Call system.