Masimo Root RDS7A User manual

Root®
Operator's Manual

www.masimo.com 1 Masimo
These operating instructions intend to provide the necessary information for proper
operation of the Root®.
There may be information provided in this manual that is not relevant for your
system.
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.
CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
For professional use. See instructions for use for full prescribing information,
including indications, contraindications, warnings, precautions and adverse events.
Wireless Radio
IC:7362A-RDS7A IC Model: RDS7A
FCC ID: VFK-RDS7A Model - RDS7A

www.masimo.com 2 Masimo
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
© 2014 Masimo Corporation
Root, SEDLine, Radical-7, rainbow, SET, Signal Extraction Technology, Masimo
and , are federally registered trademarks of Masimo Corporation.
MOC-9, Iris and ISA 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.

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Contents
About this Manual ----------------------------------------------------------------------------- 7
Product Description, Features and Intended Use ------------------------------------------ 9
Product Description and Features -------------------------------------------------------- 9
Intended Use -------------------------------------------------------------------------------- 9
Indications for Use ----------------------------------------------------------------------- 10
Safety Information, Warnings and Cautions --------------------------------------------- 13
Safety Warnings and Cautions---------------------------------------------------------- 13
Performance Warnings and Cautions -------------------------------------------------- 14
Cleaning and Service Warnings and Cautions---------------------------------------- 16
Compliance Warnings and Cautions--------------------------------------------------- 17
Chapter 1- Description ---------------------------------------------------------------------- 19
Features ------------------------------------------------------------------------------------ 19
Chapter 2- Setting Up ----------------------------------------------------------------------- 23
Unpacking and Inspection--------------------------------------------------------------- 23
Guidelines for Setting Up --------------------------------------------------------------- 23
Power On ---------------------------------------------------------------------------------- 24
Initial Battery Charging------------------------------------------------------------------ 25
Radical-7 Connection -------------------------------------------------------------------- 26
Nurse Call Connection------------------------------------------------------------------- 26
Chapter 3- Operation ------------------------------------------------------------------------ 29
About the Status Bar --------------------------------------------------------------------- 29
About the Main Screen ------------------------------------------------------------------ 31
Using the Touchscreen Interface ------------------------------------------------------- 33
Menu Navigation ------------------------------------------------------------------------- 37
Understanding Windows ---------------------------------------------------------------- 38
Accessing Main Menu Options--------------------------------------------------------- 45
Alarm Interface --------------------------------------------------------------------------- 60

Root Contents
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Trend Download---------------------------------------------------------------------------63
Lights----------------------------------------------------------------------------------------64
Chapter 4- Radius-7 --------------------------------------------------------------------------66
Chapter 5- O3 Regional Oximetry----------------------------------------------------------67
Chapter 5- MOC-9----------------------------------------------------------------------------69
Using MOC-9 Ports -----------------------------------------------------------------------69
Chapter 7- Iris ---------------------------------------------------------------------------------71
Iris Status Screen --------------------------------------------------------------------------72
Using Iris Connectivity Ports ------------------------------------------------------------73
Chapter 8- Messages -------------------------------------------------------------------------75
Messages------------------------------------------------------------------------------------75
Chapter 9- Troubleshooting -----------------------------------------------------------------77
Troubleshooting Radical-7, Radius-7 and MOC-9 Modules ------------------------77
Troubleshooting Root---------------------------------------------------------------------77
Chapter 10- Specifications-------------------------------------------------------------------81
Electrical------------------------------------------------------------------------------------81
Environmental -----------------------------------------------------------------------------81
Display--------------------------------------------------------------------------------------82
Alarms --------------------------------------------------------------------------------------83
Nurse Call Specifications-----------------------------------------------------------------83
Connectors----------------------------------------------------------------------------------83
Wireless Specifications -------------------------------------------------------------------84
EMC Compliance -------------------------------------------------------------------------85
Software Compliance ---------------------------------------------------------------------86
Safety Standards Compliance------------------------------------------------------------86
Guidance and Manufacturer's Declaration-Electromagnetic Emissions -----------87
Guidance and Manufacturer's Declaration-Electromagnetic Immunity------------88
Recommended Separation Distances ---------------------------------------------------92

Root Contents
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Symbols------------------------------------------------------------------------------------ 94
Chapter 11- Service and Maintenance ---------------------------------------------------- 97
Cleaning ----------------------------------------------------------------------------------- 97
Replacing the Fuses ---------------------------------------------------------------------- 98
Power-On Self Test ---------------------------------------------------------------------- 98
Nurse Call Setting Connections -------------------------------------------------------- 98
Battery Test ------------------------------------------------------------------------------ 100
Repair Policy ----------------------------------------------------------------------------- 100
Return Procedure ------------------------------------------------------------------------ 101
Contacting Masimo --------------------------------------------------------------------- 101
Index------------------------------------------------------------------------------------------ 105
Outside Back Cover ------------------------------------------------------------------------ 108

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 instrument 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, Features and
Intended Use
Product Description and Features
Root is a patient monitoring and connectivity platform to transform care. 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 from Masimo's Radical-7®
Pulse CO-Oximeter (Radical-7) and the Radius-7™ Wearable Pulse CO-
Oximeter (Radius-7).
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 devices.
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.
Root can transmit data for supplemental remote viewing and alarming (e.g., at a
central station).
Root can be used with the optional Radical 7, ISA product family and/or the
SEDLine module.
Root is intended to be used with connected measurement modules compatible with
Root interfaces.

Root Product Description, Features and Intended Use
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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 non-invasive monitoring of functional oxygen saturation of
arterial hemoglobin (SpO2), pulse rate (PR), 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 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 CO2 is 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 Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated
for the continuous non-invasive monitoring of functional oxygen saturation of
arterial hemoglobin (SpO2), pulse rate (PR) and/or respiratory rate (RRa). The
Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with

Root Product Description, Features and Intended Use
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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.

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 of Patient Safety Net, Radical 7, Radius-7, ISA 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 the Root. Injury to
personnel or equipment damage could occur.
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: Explosion Hazard: Do not use the Root in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
WARNING: To reduce the risk of explosion, only replace battery with Masimo
supplied parts.
WARNING: Fire Hazard: To protect against fire hazard, replace only with fuses of
same type, current rating, and voltage rating.
WARNING: Do not use the Root during magnetic resonance imaging (MRI) or in
an MRI environment.
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.

Root Safety Information, Warnings and Cautions
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WARNING: Electrical Shock Hazard: Injury to personnel could occur. Do not plug
in or remove the power cord with wet hands. 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: To ensure safety, avoid stacking multiple devices or placing anything
on the device during operation.
WARNING: Do not place the Root or accessories in any position that might cause
it to fall on the patient.
WARNING: As with all medical equipment, carefully route patient cabling 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 the 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.
Performance Warnings and Cautions

Root Safety Information, Warnings and Cautions
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WARNING: Root may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
WARNING: Root may be used during electrocautery, but 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.
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
instrument, preventing it from working properly.
CAUTION: Failure to charge Root promptly after a Low Battery alarm may result
in the instrument 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

Root Safety Information, Warnings and Cautions
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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: The wireless communication status between Root and Patient SafetyNet is
displayed by Patient SafetyNet.
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: Always charge Root when it is not in use to ensure that the battery remains
fully charged.
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
instrument 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.

Root Safety Information, Warnings and Cautions
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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.
WARNING: Do not incinerate the battery.
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 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
instrument and/or its accessories.
Note: Use Root in accordance with the Environmental Specifications section in the
Operator's Manual.
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 instructions for use or labeling.
Note: 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.
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 in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, 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:

Root Safety Information, Warnings and Cautions
www.masimo.com 18 Masimo
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 all establishments, including domestic establishments.
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.