Masimo Root Operator's Manual

Root®

Operator's Manual

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.: 949-297-7000 Fax.: 949-297-7001 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.

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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

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Root Contents

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

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Root Contents

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

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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

• Intuitive, touchscreen navigation for easy and adaptable use in any hospital

• Flexible measurement expansion through Masimo Open Connect (MOC-9™).

• Designed for third-party measurement expansion to allow other companies to add

• Built-in network connectivity gateway through Iris™ for standalone devices such as

• Docking and charging station for Radical-7

• 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.

SET measurements.

rainbow

environment.

to the platform measurements.

IV pumps, ventilators, beds, and other patient monitors.

and Radius-7® Battery Module.

and

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

), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation

(SpO

(SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo

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Root Product Description and Features, Intended Use and Indications for Use

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 (SpO 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 (SpO saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).

), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin

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 CO 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+: CO

, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO

, 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

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.

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Root Safety Information, Warnings, and Cautions

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.

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Root Safety Information, Warnings, and Cautions

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.

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Root Safety Information, Warnings, and Cautions

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.

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Root Safety Information, Warnings, and Cautions

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.

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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

Provides a docking station for the Radical-7 and Radius-7 (Note:

1 Docking Station

Root Display and

Touchscreen

3 Home Button Provides access to the Main Screen.

Root Charging

Indicator

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Battery Charging Adapter required for Radius-7). While docked, the Radical-7 can communicate monitored parameters and measurements.*

Provides a frontal display and interface for user interactions.

Shows an indication of the battery charge for Root.

Root Chapter 1: Description

Ref. Feature Description

AC Power

Indicator

Shows an indication of AC power connection Root.

Radical-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

1 Handle Allows the user to transport Root.

2 Speaker Provides audible notification.

Nurse Call

Connector

Provides a connection to a Nurse Call system.

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Root Chapter 1: Description

Ref. Feature Description

4 Ethernet Port Provides a network connection to Root using an RJ-45 cable.

5 USB Ports (2) Provide USB 2.0 connectivity.

Power Entry

Module

Equipotential

Ground Connector

Iris Connectivity

Ports (4)

Contains the input connector for a hospital grade AC power cord and the fuse holder.

Provides optional functional earthing for Root to eliminate potential differences. The use of the Equipotential Ground Connector should be in accordance with IEC 60601-1.

Provide connection for standalone devices.

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Root Chapter 1: Description

Side Views

Left Side Right Side

Ref. Feature Description

System Status

Lights

Provides an indication of system messages and alarm priority. See System Status Lights on page 67.

2 Power Button Places Root in Power On, Sleep and Power Off modes.

3 MOC-9 Ports (3) Provide connectivity for MOC-9 modules.

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Chapter 2: Setting Up

Unpacking and Inspection

To unpack and inspect Root

1. Remove Root from the shipping carton and examine it for signs of shipping damage or exposed electronics.

2. Confirm that you have all components for the Root by checking all materials against the packing list:

• Root

• AC power cord

Note: Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier.

If anything is missing or damaged, contact Masimo's Technical Service Department. See Return Procedure on page 105.

Guidelines for Setting Up

Root has a built-in bracket interface that allows it to be mounted on a pole or roll stand.

When setting up Root, follow these guidelines:

• Place on a stable, hard, flat, and dry surface near the patient.

• Maintain a minimum of three (3) centimeters (one [1] inch) of free space around

Root.

• Ensure that the back panel speaker is not covered to avoid a muffled alarm sound.

• Charge Root's battery fully before use. See Initial Battery Charging on page 23.

Root should not be operated outside the environmental conditions listed in the specifications section. See Environmental on page 92.

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Root Chapter 2: Setting Up

Power On

The Power Button can be used for Power On, Sleep, and Power Off. To Power On, press the Power Button for two (2) seconds until a single audible tone sounds.

Once Root turns on, if no Radical-7, Radius-7, or MOC-9 module is connected, the Root display shows the following message: Please Connect a Device. The user is now able to connect Radical-7, Radius-7, and MOC-9 module.

For information about Sleep Mode and Power Off, see Sleep and Power Off on page 69.

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Root Chapter 2: Setting Up

Initial Battery Charging

To charge the battery for the first time

1. Securely plug the AC power cord into power entry module.

2. Plug the hospital grade AC power cord into an AC power source.

3. Verify that Root's battery is charging by ensuring that the AC Power Indicator (1) is green and the Battery icon on the Status Bar (2) is solid green or has the charging symbol. See AC Power Indicator on page 68 and About the Status Bar on page 28.

(1)

(2)

4. The Root Charging Indicator remains orange while the battery is charging and will illuminate green and About the Status Bar on page 28.

when Root is fully charged. See Root Battery on page 52

See Safety Information, Warnings, and Cautions on page 11.

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Root Chapter 2: Setting Up

Radical-7 Connection

It is recommended that Root be powered on before performing the steps below.

1. Snap the Radical-7 into the Docking Station.

2. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to

power it on.

3. When properly connected, the Radical-7 Charging Indicator light will illuminate.

An illuminated Radical-7 Battery icon will also appear in the Status Bar. See About the Status Bar on page 28

4. Root display will show active measurements and parameters.

For Radical-7 charging conditions, see Radical-7 and Radius-7 Charging Indicator on page 68.

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Root Chapter 2: Setting Up

Radius-7 Connection

It is recommended that Root be powered on before performing the steps below.

1. Ensure the Radius-7 Battery Charging Adapter is properly docked in the Docking Station area of Root.

2. Activate the Bluetooth radio on Root. (for more information see Operator’s Manual for Radius-7).

3. Place the Radius-7 Battery Module into the charging area of the Radius-7 Battery Charging Adapter.

4. Root will emit a tone when pairing has completed (see Operator's Manual for Radius-7 for more information).

5. When properly connected, an illuminated Radius-7 Battery icon will appear in the Status Bar, and the rainbow Window will appear on the Root display.

MOC-9 Connection

To connect a MOC-9 module to Root

1. Identify the Masimo Open Connect (MOC-9 TM) end of the module.

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Root Chapter 2: Setting Up

2. Insert the MOC-9 end of the module securely into a MOC-9 port on Root.

See Chapter 6: MOC-9 on page 81

Nurse Call Connection

Use a Nurse Call connection cable to connect to a Nurse Call System.

To connect to a Nurse Call System

1. Identify the Nurse Call connection end (1/4 inch round female connector) of the cable.

2. Insert the Nurse Call connection cable securely into the compatible port on Root.

3. Depending on the connection type of the Nurse Call System, it may be necessary to orient the other end of the Nurse Call connection cable to fit correctly into the system connection.

4. For more information, see Device Settings on page 48.

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Chapter 3: Operation

The information in this chapter assumes that Root is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Root without completely reading and understanding these instructions.

About the Main Screen

The Main Screen consists of several features. The following shows the Main Screen when two different devices are connected: Radical-7 (top) showing rainbow measurements and SedLine module (bottom) showing brain function measurements.

parameters and

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Root Chapter 3: Operation

Ref. Feature Description

Status

Bar

2 Windows

Action

Bar

Displays system status as well as icons that provide shortcuts to menu items or actions. See About the Status Bar on page 28.

Provides a dynamic, user-configurable display area for all the data from connected medical devices.

Provides icons for access to Root options for Patient Admit, EMR Push, Session Management, Manual Events and the Main Menu. See Accessing Main Menu Options on page 43.

About the Status Bar

At the top of the Main Screen is the Status Bar with interactive icons. Each icon provides a shortcut to a menu item or an action on Root. An example is shown below.

Ref. Feature Description

Displays alarm status and temporarily mutes all audible alarms for

1 Alarm Silence

Root, Radical-7, Radius-7, and MOC-9 modules.

See Alarm Silence on page 62.

Displays Audio Pause status and temporarily silences an alarm

2 Audio Pause

event.

See Audio Pause on page 62.

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Root Chapter 3: Operation

Ref. Feature Description

Allows for patient monitoring to be temporarily suspended.

3 Standby Mode

4 IntelliBridge

5 Kite

6 Bluetooth

7 Wi-Fi

Available when using Root with Radical-7 or Radius-7.

See Standby Mode on page 64.

Provides access to the Device Output screen for activation or deactivation of IntelliBridge connection. If this icon is visible, then IntelliBridge connectivity has been enabled.

See Device Settings on page 48

Provides access to the Kite screen for activation or deactivation of Kite connection. If this icon is visible, then Kite connectivity has been enabled.

See Kite on page 49

Provides access to the Bluetooth screen. If this icon is visible, then Bluetooth connectivity has been enabled.

See Bluetooth on page 51.

Provides access to the Wi-Fi screen. If this icon is visible, then Wi-Fi connectivity has been enabled. The icon itself also indicates the strength of the wireless signal.

See Wi-Fi on page 50.

Provides access to the Ethernet screen. If this icon is visible, then

8 Ethernet

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Ethernet connectivity has been enabled.

See Ethernet on page 51.

Root Chapter 3: Operation

Ref. Feature Description

Provides access to the Iris screen. The example shown above indicates that standalone devices are connected to Ports 1, 2, and 3 and the information is being sent to Patient SafetyNet or

9 Iris

Connectivity Gateway.

The color of the icon matches the status colors of connected standalone devices on the Iris screen. See Chapter 7: Iris on page

83.

Displays charging status for Radical-7 or Radius-7 and provides

Radical-7 or

Radius-7 Battery

access to the Battery Radical-7 screen. The example shows that the battery is currently charging.

See Radical-7 and Radius-7 Charging Indicator on page 68.

Displays charging status for Root and provides access to the Battery

11 Root Battery

Root screen. The example shows that the battery is currently charging.

See Root Charging Indicator on page 68.

Provides access to the Sounds screen to adjust alarm and pulse tone

12 Sounds

volume. This icon does not indicate the actual volume level of the alarm and pulse tone.

See Sounds on page 47.

Displays the current time and provides access to the Localization

13 Current Time

screen which contains settings related to local time, language and geography.

See Localization on page 49.

Provides access to the Profiles screen. The example shown

14 Profiles

illustrates that Profiles is currently set to Adult for an adult patient.

See Profiles on page 59.

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Root Chapter 3: Operation

About the Action Bar

At the bottom of the Main Screen is the Action Bar with interactive icons. Each icon provides a shortcut to a menu item or an action on Root. An example is shown below.

Ref. Feature Description

1 Patient Admit Info

Provides Access for input of patient info either by importing or manual entry.

2 EMR Push Provides Access to Manual Entry of EMR Push information.

Session Management

Provides Access to Session Management. See Session Management on page 65.

4 Manual Events Provides access for manual event markers.

Provides access to the configuration options for Root and

5 Main Menu

connected medical devices.

See Accessing Main Menu Options on page 43.

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Root Chapter 3: Operation

Using the Touchscreen Interface

Using the gestures described below, the user is able to customize the viewing experience, including displaying the highest priority parameters and measurements. The availability of navigation features is dependent on the connected medical devices.

Action Illustration Example Description

Press

Slide

Swipe

Pinch

Drag

and

Drop

Below is a list of all the different types of controls available on Root and the various ways to interact with each type of control.

See Customizing Windows on page 41.

Touch and release. Action performed once finger is released.

Touch, move (left, right, up or down), and release. Moves an object across the display.

Touch, move (left, right, up or down), and release quickly.

Touch, move, and release via two touch points. Moving touch points apart zooms in, and moving them together zooms out.

Touch, hold, drag an object to desired position, and drop it by releasing.

Control Applicable Actions Description

Toggle Slide knob Switches between toggle states

Press left or right of toggle

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Quickly moves knob left or right

Root Chapter 3: Operation

Control Applicable Actions Description

Labeled Toggle Slide knob Switches between toggle states

Press left or right of toggle

Press label Quickly moves knob left or right

Spinner Press center (focused)

tile

Swipe up or down When open, scrolls through spinner tiles

Press unfocused tile When open, scrolls tile into center (focused)

Press anywhere outside spinner

Slider Slide knob Moves knob

Press anywhere along slider path

Slider Spinner Slide knob Moves knob

Press anywhere along slider path

Press center (focused) tile

Quickly moves knob left or right

When closed, expands the spinner When open, collapses the spinner

position

When open, collapses spinner

Quickly moves knob to Tap position

When closed, expands the spinner When open, collapses the spinner

Swipe up/down When open, scrolls through spinner tiles

Press unfocused tile When open, scrolls tile into center (focused)

Press anywhere outside spinner

Button Press Performs action (as defined by the button

Icon Menu Press tile Opens menu specified by tile

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position

When open, collapses spinner

description)

Root Chapter 3: Operation

Control Applicable Actions Description

Swipe left or right (anywhere)

Press bottom indicator icon

Window Press parameter or

measurement

Press and hold Enables parameter and measurement drag and

Well Press parameter or

measurement

Press and hold Enables parameter and measurement drag and

Live Waveform Swipe down Separates pleth and acoustic waveforms

Swipe up Combines pleth and acoustic waveforms

Trend Line Pinch in Zooms in

Pinch out Zooms out

Scrolls icons left or right

Quickly centers tile corresponding to indicator icon

When no parameter or measurement alarm is present, opens parameter or measurement menu When parameter or measurement alarm is present, silences parameter or measurement alarm

drop

When no parameter or measurement alarm is present, opens parameter or measurement menu When parameter or measurement alarm is present, silences parameter or measurement alarm

drop

Pan Changes time range

Press y-axis Opens parameter or measurement trend menu

Trend Zoom Press '+' Increases time range

Press '-' Decreases time range

Press time label Resets time range to default

Alarm Silence icon

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Press Silences all alarms

Root Chapter 3: Operation

Control Applicable Actions Description

Audio Pause

Press Enables Audio Pause

icon

Other Status

Press Opens relevant menu

Bar icons

Back Arrow Press Exits menu, abandons any changes

Menu Navigation

When navigating through menus and configuring settings, all changes must be confirmed by selecting OK. To cancel the changes, select Cancel. Any screen requiring selection of option(s) will time out after one (1) minute of inactivity and return to the Main Screen.

To navigate to the previous screen, press the arrow at the top left corner of the touchscreen.

To return to the Main Screen, at any time, press the Home Button at any time. The Home Button is always illuminated when Root is powered on.

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Root Chapter 3: Operation

Understanding Windows

Root creates a Window for Radical-7, Radius-7, and compatible medical devices that are connected to Root. Parameters or measurements can be expanded or minimized within a Window to customize view. Radical-7 Windows are shown in the examples below.

Windows provide waveforms along with either a Trend View or an Analog View. Trend View displays each parameter or measurement alongside a graph of its values over time. Analog View displays values in relation to alarm ranges.

Details about the displayed information of parameters and measurements can be found in the directions for use or Operator's Manual of Radical-7, Radius-7, and MOC-9 modules.

Trend View

Analog View

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Root Chapter 3: Operation

Ref. Feature Description

1 Window

Action

3 Waveform

Trend

Display

Analog

Gauge

5 Well

The area where all data from a docked Radical-7, Radius-7, or connected MOC-9 module are displayed.

This menu allows the user to change between Trend View and Analog View. For NIBP and Temperature, the action menu allows access to additional settings. Sensitivity settings can also be selected through the action menu.

Shows a parameter or measurement over time (only for Radical-7, Radius-7, and MOC-9 modules).

(Available only in Trend View) Parameters and measurements are shown as Trend Displays in Trend View. A parameter or measurement's Trend Display includes its Value Range, Numeric Value, Alarm Limits and Parameter label. See Using Trend View on page 38.

(Available only in Analog View) Parameters and measurements are shown as Analog Gauges in Analog View. A parameter's Analog Gauge includes its Alarm Limits, Numeric Value, Parameter Label, as well as Alarming, Caution and Normal Ranges. See Using Analog View on page 39.

Displays parameters and measurements which are not shown as Trend Displays or Analog Gauges.

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Root Chapter 3: Operation

Using Trend View

In Trend View, a parameter or measurement is displayed as a graph of its values over time.

The following diagram and table describe key features of a parameter's Trend Display in Trend View.

Ref. Feature Description

1 Value Range

Press to access the Trend menu where the minimum and maximum of the range can be modified.

Indicates current viewing of the parameter or measurement.

2 Trend Graph

Displays parameter and measurement over a period of time. Zoom in and out of a Trend Graph by pinching out and in.

3 Numeric Value Indicates current reading of the parameter or measurement.

4 Alarm Limits

Parameter or

Measurement Label

Indicate high and low alarm limits for the parameter or measurement, if supported.

Indicates the name of the parameter or measurement.

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Root Chapter 3: Operation

Using Analog View

The Analog View shows parameter and measurement data as a needle pointing to graduations in a circular array around a dial. This view provides indications of change that can be interpreted at a quick glance.

Analog View displays alarming and normal ranges of a parameter or measurement. These indicators can be used to alert clinicians to a patient's condition. To understand specific parameters or measurements, refer to the directions for use or operator's manuals for Radical-7, Radius-7, and the appropriate MOC-9 module(s).

The following diagrams and tables describe key features of a parameter's Gauge in Analog View.

When alarm limits for a specific parameter or measurement are set, the corresponding Analog gauge re-orients itself.

General features of the Analog View are:

Ref. Feature Description

1 Needle Indicates current status of a parameter or measurement.

2 Alarm Limits

3 Numeric Value

Parameter or Measurement

Label

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Indicate high and low alarm limits for the parameter or measurement.

Indicates current reading of the parameter or measurement.

Indicates the name of the parameter or measurement.

Root Chapter 3: Operation

Specific ranges of the Analog View are:

Ref. Feature Color Description

1 Normal Range White

Area of the display range where an alarm will not be triggered.

2 Caution Range Yellow Area of the display range that provides a caution indicator.

Alarming

Range

Red Area of the display range where an alarm will be triggered.

Some ranges display as quarter circles, others display as half circles. A quarter circle displays when the value has a physiologic normal level at one end of the range. A half circle displays when the value has a physiologic normal level in the middle of the display range.

In the example below, the SpO 88% will trigger an alarm, and the PR gauge is shown as a half circle, where values below 50

gauge is shown as a quarter circle, where values lower than

bpm and above 140 bpm will trigger an alarm.

Quarter Circle Half Circle

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Root Chapter 3: Operation

Customizing Windows

Windows can be customized by expanding and minimizing parameters and measurements in both Trend View and Analog View. When a parameter is minimized, it is only displayed in the Well with its Numeric Value and Parameter Label. When a parameter is expanded, it will be shown as either a Trend Display or Gauge.

To expand a parameter or measurement

Order Instruction

Step 1 Press and hold the Numeric Value until it dims.

Step 2 Drag the Numeric Value over any Trend Display.

Step 3 Release the Numeric Value.

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Root Chapter 3: Operation

Minimizing a parameter or measurement

Order Instruction

Step 1 Press and hold the Numeric Value until it shrinks.

Step 2 Drag the Numeric Value to the Well.

Step 3 Release the Numeric Value.

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Root Chapter 3: Operation

Accessing Main Menu Options

To access the Main Menu options

At the bottom right corner of the touchscreen, press the Main Menu icon.

The Main Menu options are:

Layout

See Layout on page 44.

rainbow

See Rainbow on page 46

Sounds

See Sounds on page 47.

Device Settings

See Device Settings on page 48.

About

See About on page 58.

Trend Settings

See Trend Settings on page 58.

Profiles

See Profiles on page 59.

Iris

See Chapter 7: Iris on page 83.

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Root Chapter 3: Operation

Layout

Use the Layout screen to select sizing options for Windows and Trend Displays.

Available Layouts

When a Radical-7 or Radius-7 is docked to Root and/or multiple MOC-9 modules are connected to Root, the user will have the option to select from several pre-configured layouts. Image below shows layout options available with Radical 7 docked in Root.

Note: Rainbow window can be viewed on a Radical 7, using software V1.5.3.5 or greater, in several of the pre-configured layouts.

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Root Chapter 3: Operation

Additional Settings for Layouts

There are different ways to display the parameters and measurements by changing the Layout Style.

Option Description Factory Default

Trend Style

Analog Range

The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View.

Controls the sizing of Trend Displays.

Controls Analog Range Setting.

Settings

Dynamic Fixed or Dynamic

Fixed Fixed or Dynamic

User Configurable Settings

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Root Chapter 3: Operation

Fixed

Ref. Description

1 A set number of Trend Displays can be shown at the same time and all Trend Displays

are fixed in size. Every additional parameter or measurement expanded will replace an existing Trend Display.

For more information about expanding parameters, see Customizing Windows on page

41.

2 Size of each Trend Display is fixed.

Dynamic

Ref. Description

1 Size of all Trend Displays decreases or increases to accommodate parameter(s)

expanded or minimized. All Trend Displays are always evenly sized.*

For more information about expanding and minimizing parameters, see Customizing Windows on page 41.

2 *Size of each Trend Display is automatically adjusted.

*When the number of Trend Displays reaches maximum viewing capacity, additional parameters expanded will result in the replacement of existing Trend Displays.

Rainbow

The rainbow icon is displayed only when a Radical-7 or Radius-7 is docked to Root. See Operator manuals for Radical-7 or Radius-7.

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Root Chapter 3: Operation

Sounds

Use the Sounds screen to control the volume level of sounds and duration of audio pause for Root.

Option Description Factory

Configurable Settings Default Setting

Alarm Volume

Pulse Tone Volume

Sets the alarm volume level.

Sets the pulse tone volume level.

Highest volume

Slide towards the left to decrease

volume to silence.

Slide towards the left to decrease

volume to silence.

1, 2, 3 minutes, Permanent*,

Permanent with Reminder*.

If Permanent is selected, there will

Audio Pause Duration

Sets the length of time that the audible alarm remains silenced, when Audio Pause is enabled. See Audio Pause on page 62.

2 minutes

be no audible alarms when Audio

Pause is enabled, but visual alarms

will still display.

If Permanent with Reminder is

selected, a tone will sound every

three (3) minutes as a reminder

that Permanent is active when

Audio Pause is enabled.

*Requires the all mute enabled option to be toggled to ON in the Access Control menu. See Access Control on page 53.

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Root Chapter 3: Operation

Device Settings

The Device Settings menu allows the user to view and customize settings for Root.

The Device Settings options are:

Localization

See Localization on page 49.

Kite

See Kite on page 49

Wi-Fi

See Wi-Fi on page 50.

Ethernet

See Ethernet on page 51.

Bluetooth

See Bluetooth on page 51.

Root Battery

See Root Battery on page 52.

Radical-7 Battery

See Radical-7 and Radius-7 Battery on page 52.

Brightness

See Brightness on page 53.

Access Control

See Access Control on page 53.

Device Output

See Device Settings on page 48.

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Root Chapter 3: Operation

Localization

Use the Localization screen to view the current date and time and configure settings related to local time, language and geography. The user can also access the Localization screen by pressing the current time on the Status Bar. See About the Status Bar on page 28.

Option Description Factory Default

Configurable Settings

Setting

Language

Date Format

Time Format

Line Frequency

Selects the language display for Root.

Sets the display format for current date.

Sets the display format for current time.

Sets to match regional power line frequency.

English

mm/dd/yy

12 hour

60 Hz 50 Hz or 60 Hz

Choose from available languages.

mm/dd/yy or

dd/mm/yy

12 hour or

24 hour

Date Sets the current date. N/A N/A

Time Sets the current time. N/A N/A

Kite

Use the Kite screen to enable or disable Kite connectivity.

Option Description Factory

Configurable Settings Default Setting

Enable Kite Connection

Activates or deactivates an active Kite connection.

Off On or Off

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Root Chapter 3: Operation

Option Description Factory

Configurable Settings Default Setting

Pairing Key

Four (4) digit code automatically assigned for active Kite session.

N/A

Automatic with active

Kite connection

Wi-Fi

The Wi-Fi radio allows for networked communication of data and alarm signals between Root and a secondary patient monitoring station, Masimo’s Patient SafetyNet over an IEEE 802.11 a/b/g wireless network. The wireless data transmission is an optional network data transmission to the wired network data transmission, using Root’s integral Ethernet Port.

Root uses only configured MAC addresses to establish wireless communications to prevent unauthorized connections to other wireless devices. As risk mitigation to the loss of the wireless communication, Root’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Root’s primary alarms.

Use the Wi-Fi screen to enable or disable Wi-Fi connectivity. When Root is connected to a Wi-Fi network, the Wi-Fi icon on the Status Bar conveys the strength of the connection. See About the Status Bar on page 28.

Option Description Factory Default

Setting

Configurable Settings

Wi-Fi

Enables or disables Wi-Fi connectivity.

Off On or Off

Additional fields in the Wi-Fi screen display read-only settings about the Wi-Fi connection that cannot be configured by the user.

Your Masimo sales representative can provide necessary information regarding an initial Wi-Fi connection. For more information, see the Patient SafetyNet Operator's Manual.

CAUTION: Unanticipated failure or alteration of network components (including but not limited to: disconnection or malfunctioning of a networking device/switch/router/ethernet cable) may result in loss of connectivity of Kite to other hospital systems. Altering or making changes to the hospital network should be done with proper knowledge.

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Root Chapter 3: Operation

Ethernet

Use the Ethernet screen to enable or disable Ethernet connectivity. When Ethernet connectivity is enabled, the Ethernet icon will appear in the Status Bar. See About the Status Bar on page 28.

Option Description Factory Default

Setting

Ethernet

Enables or disables Ethernet connectivity.

On On or Off

Configurable Settings

Additional fields in the Ethernet screen display read-only settings about the Ethernet connectivity that cannot be configured by the user.

Bluetooth

The Bluetooth radio allows for the detection of the close proximity of Masimo’s MyView Presence Tag. Root’s detection of Masimo’s MyView Presence Tag is an optional feature that allows for the display of predetermined customized settings by a clinician. Root utilizes only configured MAC addresses to establish Bluetooth communication to prevent unauthorized connection to other Bluetooth enabled devices.

Use the Bluetooth screen to enable or disable Bluetooth connectivity. When Bluetooth connectivity is enabled, the Bluetooth icon will appear in the Status Bar. See About the Status Bar on page 28.

Option Description Factory Default

Setting

Bluetooth

Enables or disables Bluetooth connectivity.

Off On or Off

Configurable Settings

For more information on how to configure MyView Presence Tag, see the Patient SafetyNet Operator's Manual.

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Root Chapter 3: Operation

Root Battery

Use the Root Battery screen to view the specific percentage of charge on the battery. The user can also access Root's Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 28.

Option Description

State of Charge Provides a read-only display of battery level remaining.

Battery Diagnostics Allows trained personnel to access battery diagnostic information.

Radical-7 and Radius-7 Battery

Use the Battery screen to view the specific percentage of charge on the Radical-7 or Radius-7's battery. For Radical-7, the user can also access the Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 28.

Option Description

State of Charge Provides a read-only display of battery level remaining.

Battery Diagnostics Allows trained personnel to access battery diagnostic information.

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Root Chapter 3: Operation

Brightness

Use the Brightness screen to adjust the brightness of the Root display.

Option Description Factory

Default

Configurable Settings

Setting

Auto Brightness

Allows automatic adjustment of Root's display brightness based on ambient light.

Off On or Off

Adjust the brightness level of the Root

Brightness

display by sliding the button (4 is

4 1, 2, 3, 4

brightest).

Access Control

Access Control contains configurable options and settings that require a password.

To enter Access Control

1. Press the key.

2. When the numeric screen displays, enter the following numbers: 6 2 7 4

Asterisks (****) will be displayed. To undo an entry, press Backspace.

3. Press Enter to access the password protected screen. Note: The password will have to be entered every time this screen is accessed.

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Root Chapter 3: Operation

Option Description Factory

Power On Profile

All Mute Enabled

Lock Alarm Volume

Optical Sensor Off Alarm Delay

Standby Enabled

Standby Reminder Tone Interval

Sets the profile used when the device is powered on.

Enables or disables parameter Alarm Silence menu option. See Sounds on page 47.

Sets the lowest alarm volume level.

Enables or disables alarm delay when Optical Sensor is off.

Enables or disables option for Standby Mode. See Standby Mode on page 64.

Allows for time interval of 30 sec, 1 min, 2 min, 3 min, 5 min, 10 min, or 15 min, as well as Off.

Default Setting

Previous Profile

Off On or Off

Off 3, 4, or Off

0 Sec.

Off On or Off

30 sec

Configurable Settings

Adult, Adult Modified, Neonatal, Pediatric, or Previous Profile

0, 5, 10, 15, 30, or 60 seconds

30 sec, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, or Off

Allow Unsigned Upgrade

Sessions Enabled

USB Port 1* baud rate

USB Port 2* baud rate

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Allows for Root software to be reverted back to older version

Enables or disables Session Management. See Session Management on page 65

Enables option to change baud rate of device

Off On or Off

9600, 19200,

921600

38400, 57600, 115200, 230400, or 921600

9600, 19200, 38400, 57600, 115200, 230400, or 921600

Root Chapter 3: Operation

Option Description Factory

Default Setting

Data Collection Enabled

Enables or disables physical data collection mode.

Off On or Off

Enables or disables EDF EDF Collection Enabled

data collection from

SedLine (See Operator's

Off On or Off

Manual for SedLine)

Synchronized Waveforms Enabled

Presence Monitoring

Enables or disables

Synchronization Waveform

view.

Enables or disables

Presence Monitoring

Off On or Off

Saves current profile Save as Adult

parameter as the Adult

N/A

Profile.

Save as Pediatric

Saves current profile

parameter as the Pediatric

Profile.

N/A

Configurable Settings

Press Save to update the profile.

Save as Neo

Factory Defaults

Saves current profile

parameter as the Neonatal

Profile.

Options are restored to

factory value.

N/A

N/A Press Restore.

Press Save to update the profile.

*Changes to USB Ports baud rate will take effect after Root is power cycled, turned off then on again.

Note: Restore Factory Defaults can only be performed during non-monitoring and no cable connections are present.

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Root Chapter 3: Operation

Device Output

The Device Output screen allows the user to configure additional data output options. A Nurse Call can be triggered based on alarm, low Signal IQ events or both. In addition, Nurse Call Polarity can be inverted to accommodate local Nurse Call station requirements.

Option Description Factory

Default Setting

Nurse Call Trigger

Controls the source of monitoring which sets off the trigger.

Alarms

Controls the mechanism of action for Nurse Call Polarity

triggering to occur. Should be changed

to accommodate institutional Nurse

Normal Normal or Inverted

Call settings.

USB Port 1 Controls the output type for USB Port 1. None

USB Port 2 Controls the output type for USB Port 2. IAP

IntelliBridge Output Options

Controls the data type output for

IntelliBridge.

Radical

Configurable Settings

Alarms, Low SIQ, Alarms + SIQ

None, SatShare, ASCII 1, IntelliBridge, or IAP

• Radical *

• Sedline, O3

Sensor 1/2/L/R*

• O3 Sensor 1/2/L/R*

• SedLine Numerics only*

• Radical Module A*

*Options when IntelliBridge is selected.

Note: The Nurse Call feature is disabled when Audio Pause is enabled and Nurse Call Trigger is set to Alarms. For more information about Audio Pause, see Audio Pause on page 62.

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Root Chapter 3: Operation

IntelliBridge Connectivity

IntelliBridge connectivity allows Root to transmit parameters and waveforms to Philips multi-parameter patient monitors that support Philips IntelliBridge device interfacing modules. This option allows parameters and waveforms on Root to be displayed on a Philips monitor and, if applicable, transmitted to the electronic medical record system.

Masimo parameters from SET, rainbow SET, and SedLine, channels are supported.

Masimo waveforms from SET, rainbow SET, channels are supported.

Note: Root supports the transmission of data only. Validations of the retrieval and display of data transmitted is the responsibility of the IntelliBridge manufacturer.

Parameters Supported

IntelliBridge connectivity allows for up to six (6) parameters and two (2) waveforms or eight (8) parameters and no waveform to be displayed on Philips monitors.

Channel Supported Parameters Waveforms

SET® SpO2, PR, Pi, PVi Pleth

rainbow® RRa, SpHb, SpCO, SpOC, SpMet RRa

SedLine® Psi™, SR, EMG, ARTF, SEFR, SEFL N/A

Capnography

FiENF, EtDES, FiDES, EtHAL, FiHAL, EtISO, FiISO, EtSEV, FiSEV, MAC

, uom %, CO2 uom kPa,

, uom mmHg, O2, AA1

etCO

, FiCO2, RR, etN2O, FiN2O, EtO2, FiO2, EtENF,

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Root Chapter 3: Operation

About

Use the About screen to view the serial number as well as software and hardware version information about Root. These details may be helpful during troubleshooting.

Option Description

Serial Number Displays the serial number for the device.

MCU 1 Displays software version number.

Processor Displays processor version number.

MCU 2 Displays software version number.

MIB Displays MOC-9 interface revision.

Information about Radical-7, Radius-7, and MOC-9 modules will display in a separate list. These fields are read-only and cannot be configured by the user.

Trend Settings

Use the Trend Settings screen to configure trend viewing on the Main Screen and trend data storage on Root.

Option Description Factory Default

Setting

Default Duration

Duration captured by Trend Graph.

2 hours

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Configurable Settings

10, 20, 30, and 45 minutes

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 18, and 24 hours

Root Chapter 3: Operation

Option Description Factory Default

Configurable Settings

Setting

Clear Trends

Delete all stored trend data.

N/A

Press Clear to delete all stored trend data.

To configure trend settings of specific parameters and measurements, see Directions for Use or Operator's Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s).

Profiles

Use the Profiles screen to select patient type.

Option Description Factory Default

Setting

Profile Name

Configure Profile

Identifies the Profiles setting in the device.

Identifies the patient category type.

Adult

Adult Adult, Pediatric, Neonatal

Root can be configured for various patient types by using the Profiles feature. Profile selection controls the management of patient configuration settings on Root. The settings of the three default profiles (Adult, Pediatric, and Neonatal) configure parameter alarms, averaging time, and sensitivity modes.

Root has the ability to support up to eight (8) custom profiles to accommodate usage in any hospital environment. For more information regarding Profiles, see the Instructions for Use or Operator’s Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s).

Configurable Settings

Adult, Pediatric, Neonatal, Custom

Iris

The status of the four (4) Iris Connectivity Ports as well as the connection type (for example, monitor, pump, ventilator) will be displayed on the Iris Status screen. See Iris Status Screen on page 84.

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Root Chapter 3: Operation

Alarm Interface

Alarms can have different priority levels and come from different sources. The following tables describe alarm behaviors in more detail.

Priority Alarm Sound

High 10-pulse burst

Medium 3-pulse burst

Alarm Source

Parameter Level

Example Explanation

The example shown here is a PR alarm as the reading (142) exceeds the upper alarm limit (140). Note that the borders of both the PR Trend Display as well as the Window are illuminated red, and the explanation of the alarm is shown at the top of the Window (High PR > 140).

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Root Chapter 3: Operation

Alarm Source

Window Level

System Level

Example Explanation

The example shown here is a "High Impedance" alarm in the lower Window.

Note that the border of the Window illuminates red, and the explanation of the alarm is shown at the top of the Window (High Impedance Detected).

The example shown here is a "Low Battery" alarm. Note that the border of the entire Root display is illuminated yellow, and the explanation of the alarm is shown in the Status Bar (Low Battery).

For more details about specific alarms on Radical-7, Radius-7, and MOC-9 modules, see Directions for Use or Operator’s Manuals for Radical-7, Radius-7, and MOC-9 modules.

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Root Chapter 3: Operation

Alarm Silence

The Alarm Silence icon is an indicator as well as a functional button. It always indicates the presence of alarms, and it can be used to temporarily suspend audible alarms for a pre-configured amount of time, known as Silence Duration.

Silence Duration configurations vary across different parameters and measurements. For more information about Silence Duration, refer to the instructions for use or Operator’s Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s).

Icon Appearance

Description Visual

Alarms

There are currently no active alarms, and no alarms have been silenced.

There are currently no active alarms, but at least one alarm has been and is still silenced.

There is currently at least one active alarm that has not been silenced.

Yes

There is currently at least one active alarm, but all active alarms are silenced.

Yes

Audio Pause

Audio Pause temporarily suspends all audible alarms on Root. When it is active, visual alarms are not impacted and will still display. The Audio Pause icon is located on the left side of the Status Bar – do not confuse with the Sounds icon on the right side of the Status Bar. See About the Status Bar on page 28.

By default, Audio Pause is inactive, and the icon appears in the following way:

Audio Pause inactive

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Root Chapter 3: Operation

To activate Audio Pause, press the icon. It will turn red and the remaining Audio Pause Duration time counts down next to the icon. The default duration for Audio Pause is 120 seconds. In the example below, Audio Pause is activated, and there are 15 seconds left until Audio Pause is inactive again.

To configure Audio Pause, see Sounds on page 47.

Audio Pause active. 15 seconds until Audio Pause is inactive.

Note: When Audio Pause is activated, powering off and then powering on Root will return

Audio Pause to its default inactive state.

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Root Chapter 3: Operation

Standby Mode

Standby Mode allows for patient monitoring to be temporarily suspended. The Standby icon (see image below) is located in the top-left corner of the screen.

To enable Standby Mode (suspend monitoring)

1. On Root, open the Access Control menu.

2. Swipe the standby enabled button to ON. Return to the home screen on Root, and the Standby icon will appear on the screen in the top-left corner.

3. Press the Standby icon, and a notification message will appear on the screen indicating that monitoring is suspended (see image below).

To exit Standby Mode (resume monitoring)

• Tap anywhere on the screen.

WARNING: When Root is in Standby Mode, monitoring is suspended and no alarms will be active, with the exception of the low battery alarm.

Note: Standby Mode will not affect any devices using Root's Iris Connectivity to Masimo Patient SafetyNet.

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Root Chapter 3: Operation

Trend Download

Root can store up to 96 hours of trend data captured at 2-second intervals from Radical-7, Radius-7, and MOC-9 modules. Trend data from Root can be transferred to a computer via USB for evaluation.

Trend data is stored in non-volatile memory, so it is not erased when Root is shut off. Trend data download is initiated using the Masimo Instrument Configuration Tool, which converts the data to a .TXT or .CSV file.

Session Management

Session Management, when enabled, allows clinicians to input a label (session name) which will output with data downloaded from Root.

Enabling Session Management

To enable session management go to Devices Settings. Choose Access Control then slide the Sessions Enabled button to the on position.

Starting Session Management

Press the session management icon on the Action Bar. Session Name window will open in which you can label the session. When data is downloaded from Root it can be identified by the label assigned to a particular session. See About the Action Bar on page 31.

Note: When Session Management is enabled multiple sessions can be recorded, not simultaneously but sequentially.

Ending Session Management

To end a session, go to the Action Bar, press the session management icon with the timer

overlay . End Session window will open. Push the End button to end the session.

Note: The maximum time for a session is 96 hours.

Screenshot Capture

The user is able to take screenshots of Root displays and download them as .png files onto a USB drive. To ensure quick downloads, the number of screenshots that can be stored in Root is limited to 20; once the limit is reached, every new screenshot taken will replace the oldest screenshot taken.

Note: Download the images onto a USB drive to avoid loss of the screenshots.

Note: There must be a folder titled “screen_shot” in the USB drive with a FAT or FAT32 system

file to enable the download of the screenshots.

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Root Chapter 3: Operation

Capturing Screenshots

To take a screenshot, swipe across the Root screen from right to left using three fingers simultaneously (see image below). A confirmation flash will appear on the entire screen and a status message will be displayed briefly at the top of the Root screen. The status message indicates the filename of the screenshot taken.

Downloading Screenshots

To download the screenshots:

1. If attached, remove Radical-7, Radius-7 and/or any MOC-9 modules from Root. Acknowledge any alarms triggered on Root.

2. Plug the USB drive into one of the two USB ports that are located on the rear panel of Root, and the screenshots will automatically begin to download. A status message will display briefly at the top of the Root screen to indicate the start of the download.

Note: There must be a folder titled “screen_shot” in the USB drive with a FAT or FAT32 system file to enable the download of the screenshots.

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Root Chapter 3: Operation

3. A confirmation status message will display briefly at the top of the Root screen

when the file transfer is complete.

4. Unplug the USB drive from Root.

To import the screenshots from the USB drive onto a computer, open the folder titled “screen_shot” (from the USB drive) on the computer to access the .png files.

Lights

System Status Lights

The System Status Lights provide visual indications of alarms and system messages. The lights will illuminate in different colors depending on the state of the device.

To locate the System Status Lights, see Side Views on page 20.

System Status Light

Light Status Alarm Priority Indication

None None Monitoring has not started.

Green None There is currently no active alarms.

Flashing Yellow Medium There is an active alarm of medium priority.

Flashing Red High There is an active alarm of high priority.

The alarm priority is determined by the Radical-7, Radius-7, and MOC-9 module(s) that are connected to Root. The following are system level alarm messages that accompany System Status Lights when Radical-7, Radius-7, and MOC-9 modules are not connected:

Status Light Message Alarm Priority

Low battery Medium

Service required High

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Root Chapter 3: Operation

AC Power Indicator

Whenever Root is connected to an AC power source, the AC power indicator illuminates.

Light Status Indication

Green Root is connected to an AC power source.

Off Root is not connected to an AC power source.

Root Charging Indicator

Whenever Root is connected to an AC power source, if not fully charged, its battery will charge.

Light Status Battery Indication

Green Battery is fully charged.

Orange Battery is charging.

Red Battery charging error.

Off Battery is not being charged. Root is not connected to AC power source.

Radical-7 and Radius-7 Charging Indicator

When Root is connected to an AC power source, it is able to charge a correctly docked Radical-7 or Radius-7. This is true whether the device is powered on, in Sleep Mode, or powered off. Conversely, when Root is not connected to AC power, it will not charge the device.

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Root Chapter 3: Operation

The light status provides a visual indication of the battery condition:

Light Status Battery Indication

Green Battery is fully charged.

Orange Battery is charging.

Red Battery is unable to charge.

Off Battery is fully charged, not being charged.

Sleep and Power Off

To put Root in the Sleep Mode or Power Off Mode, follow these steps:

State Description

Sleep Mode

Power Off Mode

Press and hold the Power Button for two (2) seconds until one (1) audible tone sounds.

Sleep Mode conserves power while enabling a quicker startup sequence.

Press and hold the Power Button for eight (8) seconds, until two (2) audible tones sound. The Home Button will flash, and the Power Button will flash orange.

Power Off Mode completely shuts down Root and results in a longer startup sequence.

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Chapter 4: Admit and Discharge to Patient SafetyNet

The Admit/Discharge icon is located at the bottom left of the screen and allows for clinicians to admit or discharge patient's on Masimo Patient SafetyNet directly from Root.

Note: In order to use this feature Masimo Patient SafetyNet software version 5.0.1.0 or higher is required.

Not Admitted

A Not Admitted message will appear on the Root screen when the sensor is placed onto a patient and a patient has not yet been admitted on the Root. Press the Admit button on the screen to admit the patient or press skip and the patient data will not be transmitted to the Masimo Patient Safety Net.

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Root Chapter 4: Admit and Discharge to Patient SafetyNet

Admitting a Patient

To admit a patient:

1. Press the admit icon on the bottom-left of the main screen.

2. Enter the authentication PIN.

3. Either press the patient info search button (1) to select existing patient information, or enter new patient information in the data fields (2).

4. Press the assignments search button (3) and select the primary and secondary pagers (4).

5. Press the Admit button (5).

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Root Chapter 4: Admit and Discharge to Patient SafetyNet

Discharging a Patient

To discharge a patient:

1. Press the discharge icon on the bottom-left of the main screen.

2. Enter the authentication PIN.

3. Press the Discharge button. A confirmation message will appear.

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Root Chapter 4: Admit and Discharge to Patient SafetyNet

4. Press the Discharge confirmation button. Note: Once patient is discharged from Root, or session is ended, the NIBP

parameter display will be cleared.

Not Monitoring Message

When the sensor is off the patient for an extended period of time, a Not Monitoring message will appear on the screen. Acknowledge the message by pressing Cancel or Discharge. Press Discharge to discharge the patient that is currently admitted on the Root, or press Cancel to keep the same patient admitted.

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Root Chapter 4: Admit and Discharge to Patient SafetyNet

Monitoring Resumed Message

When the sensor is taken off and placed back onto a patient, a Monitoring Resumed message will appear on the Root screen.

If this is a new patient, press Discharge on the screen to discharge the previous patient. If the same patient is being monitored, press Confirm to continue monitoring the same patient.

Electronic Medical Record (EMR) Push

The Electronic Medical Record (EMR) Push feature allows clinicians to send validated patient vitals data from any of the Masimo devices, MOC-9 modules, or Iris devices connected to Root directly to a Patient Data Management System, such as an Electronic Medical Record (EMR).

Determining EMR Push is Active

When connected to a configured Patient SafetyNet or Iris Gateway, the EMR Push icon

appears on the bottom of the Root main/home screen when it is active.

Note: To use this feature, Masimo Patient SafetyNet software version 5.0.1.0 or higher is required.

Note: The system can be configured to require clinicians to provide access credentials to activate the EMR Push feature.

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Root Chapter 4: Admit and Discharge to Patient SafetyNet

Sending Data to the EMR

1. To send user data, select the EMR push icon at the bottom of the Root main/home screen.

2. When the EMR Push screen appears, the following manual entry items can be configured before sending data to EMR:

• Glucose

• Temperature

• Systolic blood pressure

• Diastolic blood pressure

• Level of Consciousness

• Pain Scale

• Supplemental O

See EMR Push Manual-Entry Item Settings on page 78 for information and settings.

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Root Chapter 4: Admit and Discharge to Patient SafetyNet

3. The information gathered by the device is sent to the EMR, by default.

In the example below, note that the temperature has been obtained using the Root with integrated temperature function.

4. Select to send the data, including any manual entries, to the EMR.

5. A Successfully Sent Data to EMR confirmation screen appears. Select OK.

6. Select OK to return Root to the main screen.

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Root Chapter 4: Admit and Discharge to Patient SafetyNet

EMR Push Manual-Entry Item Settings

Options Description

Default

User Configurable Settings

Settings

Factory

Glucose

Patient Glucose reading

NA User numeric input

RR* Respiration Rate -- -- and 1 to 70 in increments of 1

-- and from 80.1°F to 110.0°F in

Temperature**

Patient temperature measurement

increments of 0.1

-- and from 26.8°C to 43.3°C in increments of 0.1

Systolic**

Diastolic**

Level of Consciousness

Pain Scale

Patient systolic measurement

Patient diastolic measurement

Patient level of Consciousness

Level of pain patient feels

-- -- and 41 to 260 in increments of 1

-- -- and 21 to 200 in increments of 1

--, A (Alert), V (Responds to Voice),

P (Responds to Pain), or U (Unresponsive)

-- -- and 1 to 10 in increments of 1

* Not displayed unless an appropriate device or sensor is connected to Root.

** Not displayed if a temperature/blood pressure measurement is taken using Root with noninvasive blood pressure and temperature.

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Chapter 5: Radius-7

The Radius-7 is a patient wearable device for continuous monitoring when the patient is ambulatory. It measures arterial oxygen saturation (SpO (Pi), and Pleth Variability Index (PVi

), carboxyhemoglobin (SpCO®), total oxygen content (SpOC), methemoglobin

(SpHb

(SpMet

), Acoustic Respiration Rate (RRa®). It uses a Bluetooth® connection to transfer

) along with optional measurements of hemoglobin

), pulse rate (PR), perfusion index

parameter data to Root. When Radius-7 is connected to Root via Bluetooth, the device automatically creates a Window that displays all the data from Radius-7.

Root also acts as a charging station for Radius-7. Radius-7 is docked onto Root via a Battery Charging Adapter. See Radius-7 Operator's Manual for more information.

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Chapter 6: MOC-9

Flexible measurement expansion is enabled through MOC-9. It can display parameters and measurements captured by SedLine, ISA Capnography, and third-party technologies in an all-in-one view on Root.

When any MOC-9 module is connected, Root automatically creates a Window that displays all the data from that module. The example below shows the “SedLine” and “Capnography” Windows which display data from the SedLine brain function monitoring and ISA capnography MOC-9 modules that are connected to Root.

Using MOC-9 Ports

Use a MOC-9 cable to connect other MOC-9 modules to Root.

To use an MOC-9 Port

1. Identify the MOC-9 end of the cable.

2. Orient the cable to fit correctly into an MOC-9 Port.

3. Insert the MOC-9 cable securely into any of the three (3) compatible ports on

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Root.

Chapter 7: Iris

Iris allows a variety of standalone devices to connect to Root. Patient data can be passed through Root to Patient SafetyNet or Connectivity Gateway, which can send the data to electronic health records.

Below is an example of one way Root can be used in a network setting using Patient SafetyNet. Root receives and may display information from Radical-7, MOC-9 modules, as well as standalone devices.

Ref. Description

1 Standalone devices connected via Iris (e.g., monitor, pump, ventilator)

Root

3 Patient SafetyNet View Station

4 Patient SafetyNet or Masimo Connectivity Gateway

5 Notification devices

6 Electronic Health Records system

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Root Chapter 7: Iris

Iris Status Screen

Information about Iris Connectivity Ports is displayed on this screen, which is accessible by selecting the Iris option on the Main Menu.

Connection Status Color

Green

Yellow

Gray No standalone device is connected to the Iris Connectivity Port.

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Description of Connection

Standalone device is successfully connected to Root, and Root is successfully connected to a Patient SafetyNet or Connectivity Gateway.

Standalone device connection to Iris adapter is established, but there is no communication to SafetyNet or Connectivity Gateway

Root Chapter 7: Iris

Additionally, the Ports are also mapped to the Iris icon on the Status Bar. When a standalone device is connected to Root via one of the Ports, the corresponding part of the icon will be lit green or yellow. In the example below, a standalone device is connected to Iris Connectivity Port 1.

Port 1 (connected)

Port 3 Port 4

Port 2

Status and connection type are read-only and not configurable by the user. For more information on Iris connectivity, see Instructions for Use or Operator’s Manual for the appropriate version of Masimo Patient SafetyNet.

Using Iris Connectivity Ports

Use Iris Adapters and RJ-45 cables to connect standalone devices to Root.

To connect a standalone device via an Iris Connectivity Port:

1. Connect the Iris Adapter to the standalone device. Refer to the Iris Adapter

Directions for Use.

2. Connect the RJ-45 end of the Iris Adapter to any of the four (4) compatible Iris

Connectivity Ports on Root using a RJ-45 cable.

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Chapter 8: Messages

The following messages are specific to Root:

Message Explanation Next Step

Battery Charge is Low.

MOC-9 module Disconnected

(e.g. SedLine Disconnected)

Radical-7 Disconnected

Radius-7 Disconnected

For additional messages, see Instructions for Use or Operator's Manuals for Radical-7, Radius-7, and MOC-9 modules.

The internal battery needs to be charged. System Status Lights flash yellow.

A MOC-9 module is disconnected from Root.

Radical-7 is disconnected from Root.

Radius-7 is disconnected from Root.

Charge Root's battery using AC power.

Reconnect module or acknowledge message by pressing the Alarm Silence icon.

Reconnect Radical-7 or acknowledge message by pressing the Alarm Silence icon.

Reconnect Radius-7 or acknowledge message by pressing the Alarm Silence icon.

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Chapter 9: Troubleshooting

Troubleshooting Radical-7, Radius-7, and MOC-9 Modules

For information on troubleshooting values that are provided from Radical-7, Radius-7, and MOC-9 modules, refer to their respective Instructions for Use or Operator's Manuals.

Troubleshooting Root

Symptom Possible Cause Correction

Power Button not pressed long enough.

Press Power Button for two (2) seconds.

Root does not turn on.

Root turns on, but Main Screen is dim or blank.

Touch functionality is not responsive.

Not displaying data from Radical-7, Radius-7, or MOC-9 modules.

Iris screen does not display connection status for standalone devices.

The battery may be depleted.

One of the fuses is not operating properly.

The brightness setting is not correct.

Internal failure.

Connection error.

Connection error. Unplug and replug the Iris Adapter.

Connect Root to AC power to charge battery.

Replace the fuse. See Replacing the Fuses on page 103.

Adjust the brightness setting. See Brightness on page 53.

If the condition persists, Root requires service. Contact Masimo Technical Support. See Return Procedure on page 105.

Root requires service. Contact Masimo Technical Support. See Return Procedure on page 105.

Ensure that the connections are securely in place and properly plugged in, or that the cable is not defective. For Radius-7, ensure that the device is paired with Root via Bluetooth. Refer to Operator's Manual of Radius-7 for more information.

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Root Chapter 9: Troubleshooting

Symptom Possible Cause Correction

Iris screen does not display connection status for standalone devices.

Root has a continuous speaker tone.

Power Button does not respond when pressed.

Home Button does not work when pressed.

Battery does not charge.

Root Charging Indicator illuminates red.

Nurse Call does not communicate.

Connection error.

Internal failure.

Power Button may need to be pressed for a longer time.

Internal failure.

AC power cable may be disconnected.

Internal failure.

Connection error.

If the problem persists, refer to instructions for use or operator's manual for the connected standalone devices or Iris section of the instructions for use or operator’s manual for the appropriate version of Patient SafetyNet.

To silence an alarm, press the Power Button for eight (8) seconds. If alarm continues to sound, Power Off Root. Root requires service. See Return Procedure on page 105.

To Power On when turned off or in Sleep Mode, press Power Button for two (2) seconds.

To Power Off when turned on or in Sleep Mode, press the Power Button for eight (8) seconds.

Root requires service. See Return Procedure page 105.

Unplug and replug AC power cable.

Root requires service. See Return Procedure page 105.

Unplug and replug Nurse Call connector.

See Nurse Call Setting Connections on page

104.

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Chapter 10: Specifications

This chapter contains specifications of Root.

For information on the specifications of Radical-7, Radius-7, MOC-9 modules, and standalone devices, see Directions for Use or Operator's Manuals for these devices.

Alarms

Audio Alarm Type

System Status Light Color

Audio Description

High Priority Flashing Red 10-pulse burst, pulse spacing: 0.250s, 0.250s,

0.500s, 0.250s, repeat time:10s

Medium Priority

Flashing Yellow 3-pulse burst, pulse spacing: 0.375s, 0.375s, repeat

time: 7s

Low Priority Solid Yellow No audio

Nurse Call Specifications

The Nurse Call relays have the following electrical specifications per switch:

Parameter Specification

Max Voltage 36 VDC or 24 VAC peak

Connectors

Connector Type Number of Ports

Ethernet 10/100 Mbps 1

Nurse Call 1/4 inch round female 1

MOC-9 Masimo Connector 3

USB USB 2.0 2

Iris RS-232/RJ-45 4

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Root Chapter 10: Specifications

Electrical

Root

AC Power requirements 100-240 VAC~, 47-63 Hz, 65VA Max

Fuses (2) 2 Amp, Metric, (5x20mm), 250V, 1500A Breaking Capacity

Battery

Type Lithium Ion

Voltage 10.8V (Nominal)

Capacity 4 hours*

Maximum Charging Time 4 hours

*This represents approximate run time at the lowest brightness, using a fully charged battery.

Environmental

Root

Operating Temperature 32°F to 122°F (0°C to 50°C)

Transport/Storage Temperature -40°F to 158°F (-40°C to 70°C)

Operating Humidity 10% to 95%, non-condensing

Storage Humidity 10% to 95%, non-condensing

500 mbar to 1060 mbar

Operating Air Pressure

-1000 ft to 18,000 ft

(-304 m to 5,486 m)

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Root Chapter 10: Specifications

Touchscreen Display

Characteristic Description

Type Backlit Active Matrix TFT LCD

Resolution 1280 x 800 pixels

Size 10.1 in (25.65 cm) Diagonal

Color 24 bit RGB

Touchscreen Type Multi-Touch P-Cap

Wireless Specifications

Communication (Wi-Fi)

Type WLAN Radio: IEEE 802.11 a/b/g

Frequency

802.11a: 5180-5240 MHz, 5745-5825 MHz

802.11b/g: 2412-2462 MHz

Max Peak Output Power WLAN 17 dBm

Classification of Output Power Rating

Conducted

Output Power Type Fixed at the Factory

Modulation Types OFDM, BPSK, CCK

Modulation Signals Analog and Digital

802.11a - 6, 9, 12, 18, 24, 36, 48, 54 Mbps.

Available Data Rates

802.11b - 1, 2, 5.5, 11 Mbps.

802.11g - 6, 9, 12, 18, 24, 36, 48, 54 Mbps.

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Root Chapter 10: Specifications

Communication (Bluetooth)

Type Bluetooth

Frequency 2402-2480 MHz

Max Peak Output Power Bluetooth 1.3 dBm

Classification of Output Power Rating

Conducted

Output Power Type Fixed at the Factory

Modulation Types DH5

Modulation Signals Analog and Digital

Available Data Rates Bluetooth 1 Mbps

Security and Authentication

Encryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES

Authentication

Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST

Radio Compliance

USA FCC ID: VKF-RDS7A or VKF-RDS7

Model - RDS-7A or RDS-7

Canada IC:7362A-RDS7A or 7362A-RDS7

IC Model: RDS-7A or RDS-7

RSS-210

Europe

EN 300 328

EN 301 893

EN 301 489-1

EN 301 489-17

R & TTE Directive

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Root Chapter 10: Specifications

Compliance

EMC Compliance

EN 60601-1-2, Class A

Software Compliance

EN 60601-1-4:1996 + A1: 1999

Electrical and Mechanical Safety

UL 60601-1:2003

CAN/CSA 22.2 No. 601.1:2005

IEC 60601-1 / UL 60601-1: 1988 + A1: 1991 + A2:1995

EN 60601-1: 1990 + AI: 1993 + A2:1995

IEC 60601-1:2005

IEC-60601-2-49:2001

IEC-60601-1-8

Equipment Classification per IEC 60601-1

Type of Protection

Class I (on AC power)

Internally powered (on battery power)

Degree of Protection of Electrical Shock Defibrillation proof BF-Applied Part

Protection against harm from liquid ingress

IPX1 Protection against liquid drops falling vertically

Mode of Operation Continuous Operation

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Root Chapter 10: Specifications

Guidance and Manufacturer's Declaration-Electromagnetic Emissions

Guidance and Manufacturer's Declarations - Electromagnetic Emissions

The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.

Emission Test Compliance Electromagnetic Environment - Guidance

RF Emissions

CISPR 11

RF Emissions

CISPR 11

Harmonic Emissions

IEC 61000-3-2

Voltage Fluctuations / Flicker Emissions

IEC 61000-3-3

Group 1

Class A

Complies

ME Equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

For hospital environment only.

Not intended for use in a domestic environment.

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Root Chapter 10: Specifications

Guidance and Manufacturer's Declaration-Electromagnetic Immunity

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.

Immunity Test IEC 60601

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines.

IEC 61000-4-11

Test Level

+6 kV contact

+8 kV air

+2 kV for power supply lines.

+1 kV for input/output lines.

+1 kV differential mode

+2 kV common mode

100% for 0.5 cycle

60% for 5 cycles

30% for 25 cycles

100% for 5 seconds

Compliance Level

+6 kV contact

+8 kV air

-- Mains power quality should be that of

Electromagnetic Environment Guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

a typical commercial or hospital environment.

a typical hospital environment.

a typical commercial or hospital environment. Root provides a battery for continued operation during power mains interruption for a maximum of 4 hours.

Power frequency (50 / 60 Hz) magnetic field.

IEC 61000-4-8

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3 A/m 3 A/m Power frequency magnetic fields

should be at levels characteristic of typical location in a typical hospital environment.

Root Chapter 10: Specifications

should be

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3 Vrms

Portable and mobile RF communications equipment used no closer to any part of the ME Equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

3 V/m

80 MHz to 800 MHz

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey

, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

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Masimo Root Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

About This Manual

Product Description and Features, Intended Use and Indications for Use

Product Description and Features

Intended Use

Indications for Use

Contraindication

Safety Information, Warnings, and Cautions

Safety Warnings and Cautions

Performance Warnings and Cautions

Kite

Patient SafetyNet System

Cleaning and Service Warnings and Cautions

Compliance Warnings and Cautions

Chapter 1: Description

Features

Front View

Back View

Side Views

Chapter 2: Setting Up

Unpacking and Inspection

Guidelines for Setting Up

Power On

Initial Battery Charging

Radical-7 Connection

Radius-7 Connection

MOC-9 Connection

Nurse Call Connection

Chapter 3: Operation

About the Main Screen

About the Status Bar

About the Action Bar

Using the Touchscreen Interface

Menu Navigation

Understanding Windows

Using Trend View

Using Analog View

Customizing Windows

Accessing Main Menu Options

Layout

Additional Settings for Layouts

Rainbow

Sounds

Device Settings

Localization

Kite

Wi-Fi

Ethernet

Bluetooth

Root Battery

Radical-7 and Radius-7 Battery

Brightness

Access Control

Device Output

IntelliBridge Connectivity

Parameters Supported

About

Trend Settings

Profiles

Iris

Alarm Interface

Alarm Silence

Audio Pause

Standby Mode

Trend Download

Session Management

Screenshot Capture

Capturing Screenshots

Downloading Screenshots

Lights

System Status Lights

AC Power Indicator

Root Charging Indicator

Radical-7 and Radius-7 Charging Indicator

Sleep and Power Off

Chapter 4: Admit and Discharge to Patient SafetyNet

Not Admitted