Masimo Root User manual

Operator's Manual
Root®
with noninvasive blood pressure and
temperature

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:VKF-RDS7A IC:7362A-RDS7A IC Model: RDS7A
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
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
Conforms to 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
, 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 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 --------------------------------------------------------------------------------------- 11
Safety Information, Warnings, and Cautions----------------------------------------------------------13
Safety Warnings and Cautions----------------------------------------------------------------------- 13
Performance Warnings and Cautions---------------------------------------------------------------16
Cleaning and Service Warnings and Cautions ----------------------------------------------------18
Compliance Warnings and Cautions----------------------------------------------------------------19
Chapter 1: Description ------------------------------------------------------------------------------------ 21
Features-------------------------------------------------------------------------------------------------- 21
Chapter 2: Setting Up-------------------------------------------------------------------------------------25
Unpacking and Inspection ---------------------------------------------------------------------------25
Guidelines for Setting Up-----------------------------------------------------------------------------25
Power On ------------------------------------------------------------------------------------------------26
Initial Battery Charging ------------------------------------------------------------------------------- 27
Radical-7 Connection----------------------------------------------------------------------------------28
Radius-7 Connection-----------------------------------------------------------------------------------28
MOC-9 Connection-------------------------------------------------------------------------------------29
Nurse Call Connection ------------------------------------------------------------------------------- 30
Attach the Probe Well-------------------------------------------------------------------------------- 30
Attach the Temperature Probe ----------------------------------------------------------------------31
Attach NIBP Cuff --------------------------------------------------------------------------------------- 31
Masimo Kite--------------------------------------------------------------------------------------------- 31
Bluetooth Devices--------------------------------------------------------------------------------------31
Chapter 3: Operation------------------------------------------------------------------------------------- 33
About the Main Screen------------------------------------------------------------------------------- 33
About the Status Bar ----------------------------------------------------------------------------------34
About the Action Bar --------------------------------------------------------------------------------- 36

Root NIBPT Contents
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Using the Touchscreen Interface-------------------------------------------------------------------- 37
Menu Navigation --------------------------------------------------------------------------------------40
Understanding Windows ----------------------------------------------------------------------------- 41
Accessing Main Menu Options ---------------------------------------------------------------------- 49
Alarm Interface----------------------------------------------------------------------------------------- 77
Trend Download---------------------------------------------------------------------------------------- 81
Session Management ---------------------------------------------------------------------------------82
Screen Capture -----------------------------------------------------------------------------------------83
Lights ----------------------------------------------------------------------------------------------------86
Chapter 4: Temperature Measurement ----------------------------------------------------------------89
Operation - Temperature -----------------------------------------------------------------------------89
Temperature Probes----------------------------------------------------------------------------------- 91
Chapter 5: NIBP Measurement--------------------------------------------------------------------------93
Patient Measurement Mode -------------------------------------------------------------------------93
Cuff Selection and Placement -----------------------------------------------------------------------93
Patient Conditions------------------------------------------------------------------------------------- 94
Operation - NIBP---------------------------------------------------------------------------------------95
Chapter 6: Admit and Discharge to Patient SafetyNet ------------------------------------------- 103
Not Admitted ----------------------------------------------------------------------------------------- 103
Admitting a Patient --------------------------------------------------------------------------------- 104
Discharging a Patient ------------------------------------------------------------------------------- 105
Not Monitoring Message --------------------------------------------------------------------------- 106
Monitoring Resumed Message----------------------------------------------------------------------107
Chapter 7: Electronic Medical Record (EMR) Push------------------------------------------------- 109
Determining EMR Push is Active------------------------------------------------------------------ 109
Manually Entering Patient Data------------------------------------------------------------------- 109
Sending Patient Data to the EMR----------------------------------------------------------------- 110
Chapter 8: Radical-7 ------------------------------------------------------------------------------------- 111
Chapter 9: Radius-7 --------------------------------------------------------------------------------------113
Chapter 10: MOC-9---------------------------------------------------------------------------------------115
Using MOC-9 Ports -----------------------------------------------------------------------------------115
Chapter 11: Iris-------------------------------------------------------------------------------------------- 117
Using Iris Connectivity Ports -----------------------------------------------------------------------118

Root NIBPT Contents
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Iris Icon ------------------------------------------------------------------------------------------------ 119
Iris Screen --------------------------------------------------------------------------------------------- 120
Chapter 12: Bluetooth Devices ------------------------------------------------------------------------ 123
Connect Device to Root ----------------------------------------------------------------------------- 123
Chapter 13: Messages----------------------------------------------------------------------------------- 125
Chapter 14: Troubleshooting -------------------------------------------------------------------------- 129
Troubleshooting Radical-7, Radius-7, and MOC-9 Modules----------------------------------- 129
Troubleshooting Root ------------------------------------------------------------------------------- 129
Chapter 15: Specifications ----------------------------------------------------------------------------- 133
Measurement Accuracy ----------------------------------------------------------------------------- 133
Alarms-------------------------------------------------------------------------------------------------- 134
Nurse Call Specifications --------------------------------------------------------------------------- 134
Connectors -------------------------------------------------------------------------------------------- 134
Display Ranges --------------------------------------------------------------------------------------- 135
NIBP Pressurization Ranges ----------------------------------------------------------------------- 136
Electrical----------------------------------------------------------------------------------------------- 136
Environmental---------------------------------------------------------------------------------------- 136
Touchscreen Display--------------------------------------------------------------------------------- 137
Wireless Specifications------------------------------------------------------------------------------ 137
Compliance-------------------------------------------------------------------------------------------- 139
Guidance and Manufacturer's Declaration-Electromagnetic Emissions---------------------141
Guidance and Manufacturer's Declaration-Electromagnetic Immunity -------------------- 142
Recommended Separation Distances ------------------------------------------------------------ 144
Symbols------------------------------------------------------------------------------------------------ 145
Chapter 16: Service and Maintenance --------------------------------------------------------------- 149
Cleaning ----------------------------------------------------------------------------------------------- 149
Replacing the Fuses --------------------------------------------------------------------------------- 149
Power-On Self Test----------------------------------------------------------------------------------- 150
NIBP Module Calibration Test --------------------------------------------------------------------- 150
Zero Point Calibration------------------------------------------------------------------------------- 152
Span Point Calibration------------------------------------------------------------------------------ 153
NIBP Air Leak Test ----------------------------------------------------------------------------------- 154
Overpressure Test------------------------------------------------------------------------------------ 156

Root NIBPT Contents
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Nurse Call Setting Connections ------------------------------------------------------------------- 159
Battery Test------------------------------------------------------------------------------------------- 160
Repair Policy------------------------------------------------------------------------------------------ 160
Return Procedure ------------------------------------------------------------------------------------ 160
Masimo Technical Services ------------------------------------------------------------------------ 160
Contacting Masimo-----------------------------------------------------------------------------------161
Appendix: Concepts of Alarm Response Delay ----------------------------------------------------- 163
Concepts of Alarm Response Delay --------------------------------------------------------------- 163
Index ------------------------------------------------------------------------------------------------------- 165

www.masimo.com 7 Masimo
About This Manual
This manual explains how to set up and use Root® with noninvasive blood pressure and
temperature. 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.

www.masimo.com 9 Masimo
Product Description and Features,
Intended Use and Indications for Use
Product Description and Features
Root®with noninvasive blood pressure and temperature 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.
•Integrated noninvasive blood pressure (NIBP) technology.
•Optional integrated temperature technology.
•Ability to display data on a secondary display.
•Ability to display data from external devices using Bluetooth.
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 Root

Root NIBPT Product Description and Features, Intended Use and Indications for Use
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Monitoring System, when used with the optional ISA module, is not intended to be used in
road ambulances.
The Masimo Root Monitoring System can communicate with network systems 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 non-invasive 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
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 non-invasive 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 Oximeter and Accessories are indicated for the
continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse
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 side stream 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.
The optional temperature module is indicated to measure temperature (oral, adult axillary,
pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be
used by clinicians and medically qualified personnel. It is available for sale only upon the
order of a physician or licensed health care provider.

Root NIBPT Product Description and Features, Intended Use and Indications for Use
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The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive
measurement of arterial blood pressure in healthcare environments. The NIBP module is
designed to measure blood pressure for patient population described in the following table:
Patient Population Approximate Age Range
Newborn (neonate) Birth to 1 month of age
Infant 1 month to 2 years of age
Child 2 to 12 years of age
Adolescent 12-21 years of age
Adult 21 years of age and older
Contraindication
There are no contraindications.

www.masimo.com 13 Masimo
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, TIR-1 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.

Root NIBPT Safety Information, Warnings, and Cautions
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WARNING: As with all medical equipment, carefully route patient cables to reduce the
possibility of patient entanglement or strangulation.
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.
Noninvasive Blood Pressure
WARNING: Frequently check the blood pressure monitoring site to ensure adequate
circulation.
WARNING: Only use Root in neonatal mode with a neonatal blood pressure cuff to measure
blood pressure on neonates.
WARNING: Neonatal blood pressure measurements must always use a three (3) meter hose
in order to avoid overpressure error caused by lack of air volume within the overall pneumatic
system.
WARNING: Frequently check the blood pressure monitoring site to ensure adequate
circulation.
WARNING: Do not apply the cuff to a limb that is on the same side of a mastectomy.

Root NIBPT Safety Information, Warnings, and Cautions
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WARNING: Do not use or stop blood pressure measurements if the patient appears to be
affected by the pressurization of the cuff due to a physical condition (i.e. pregnant,
pre-eclamptic, etc.)
WARNING: Too frequent blood pressure measurements can cause injury to the patient due to
blood flow interference.
WARNING: Do not attach the cuff to a limb being used for IV infusions or any other
intravascular access, therapy or an arterio-venous (A-V) shunt. The cuff inflation can
temporarily block blood flow, potentially causing harm to the patient.
WARNING: Before applying the cuff on the patient, confirm the cuff size is appropriate.
WARNING: When a blood pressure measurement error code occurs, any blood pressure values
reported should be disregarded.
CAUTION: Applying the blood pressure cuff over a wound can cause further injury.
CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure
resulting in blood flow interference and potentially harmful injury to the patient.
CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse
oximeter probe), the pressurization within the cuff can cause temporary loss of function of the
monitoring equipment.
Optional Integrated Temperature
WARNING: Always use single-use disposable probe covers to limit patient
cross-contamination and/or patient discomfort.
WARNING: Before use, verify the color of the removable probe well to confirm the proper
application site: Red (rectal), Blue (oral/axillary).
WARNING: The use of any other probe cover may produce temperature measurement errors
or may result in inaccurate readings.
WARNING: Do not take axillary temperature through the patient's clothing, direct probe
cover-to-skin contact is required.
CAUTION: Long-term continuous temperature monitoring, greater than 5 minutes, is not
recommended.
CAUTION: Ensure probe well is properly in place.
CAUTION: Biting the probe tip while taking a temperature may result in damage to the
probe.
CAUTION: Use of the incorrect probe at the measurement site will result in temperature
errors.
Note: If a reliable spot check measurement cannot be made, the temperature module will
automatically switch to continuous mode to make the measurement.
Note: Verify the compatibility of the temperature probe and probe cover before use with
Root.

Root NIBPT Safety Information, Warnings, and Cautions
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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.
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.

Root NIBPT Safety Information, Warnings, and Cautions
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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.
Note: When the Root monitor is in synchronized waveform view, the EEG Chart Speed of the
SedLine Window cannot be changed.
Noninvasive Blood Pressure
WARNING: Before applying the cuff on the patient, confirm the cuff size is appropriate.
WARNING: When a blood pressure measurement error code occurs, any blood pressure values
reported should be disregarded.
CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse
oximeter probe), the pressurization within the cuff can cause temporary loss of function of the
monitoring equipment.
Optional Integrated Temperature
WARNING: The use of any other probe cover may produce temperature measurement errors
or may result in inaccurate readings.
WARNING: Do not take axillary temperature through the patient's clothing, direct
probe-cover-to-skin contact is required.
CAUTION: Long-term continuous temperature monitoring, greater than 5 minutes, is not
recommended.
CAUTION: Ensure probe well is properly in place.
CAUTION: Biting the probe tip while taking a temperature may result in damage to the
probe.
CAUTION: Use of the incorrect probe at the measurement site will result in temperature
errors.
Note: If a reliable spot check measurement cannot be made, the temperature module will
automatically switch to continuous mode to make the measurement.
Note: Verify the compatibility of the temperature probe and probe cover before use with
Root.

Root NIBPT 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: To prevent damage to the temperature probe do not autoclave.
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.