Masimo RDS7A User Manual

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Root®

Operator's Manual

These operating instructions intend to provide the necessary information for proper operation of the Root®.

There may be information provided in this manual that is not relevant for your system.

Do not operate Root without completely reading and understanding these instructions.

NOTICE:

Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Wireless Radio

IC:7362A-RDS7A IC Model: RDS7A

FCC ID: VFK-RDS7A Model - RDS7A

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Masimo

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

Root, SEDLine, Radical-7, rainbow, SET, Signal Extraction Technology, Masimo

, are federally registered trademarks of Masimo Corporation.

and

MOC-9, Iris and ISA are trademarks of Masimo Corporation.

The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

All other trademarks and registered trademarks are property of their respective owners.

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Masimo

Contents

About this Manual ----------------------------------------------------------------------------- 7

Product Description, Features and Intended Use ------------------------------------------ 9

Product Description and Features -------------------------------------------------------- 9

Intended Use -------------------------------------------------------------------------------- 9

Indications for Use ----------------------------------------------------------------------- 10

Safety Information, Warnings and Cautions --------------------------------------------- 13

Safety Warnings and Cautions ---------------------------------------------------------- 13

Performance Warnings and Cautions -------------------------------------------------- 14

Cleaning and Service Warnings and Cautions ---------------------------------------- 16

Compliance Warnings and Cautions --------------------------------------------------- 17

Chapter 1- Description ---------------------------------------------------------------------- 19

Features ------------------------------------------------------------------------------------ 19

Chapter 2- Setting Up ----------------------------------------------------------------------- 23

Unpacking and Inspection --------------------------------------------------------------- 23

Guidelines for Setting Up --------------------------------------------------------------- 23

Power On ---------------------------------------------------------------------------------- 24

Initial Battery Charging ------------------------------------------------------------------ 25

Radical-7 Connection -------------------------------------------------------------------- 26

Nurse Call Connection ------------------------------------------------------------------- 26

Chapter 3- Operation ------------------------------------------------------------------------ 29

About the Status Bar --------------------------------------------------------------------- 29

About the Main Screen ------------------------------------------------------------------ 31

Using the Touchscreen Interface ------------------------------------------------------- 33

Menu Navigation ------------------------------------------------------------------------- 37

Understanding Windows ---------------------------------------------------------------- 38

Accessing Main Menu Options --------------------------------------------------------- 45

Alarm Interface --------------------------------------------------------------------------- 60

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Masimo

Root Contents

Trend Download ---------------------------------------------------------------------------63

Lights----------------------------------------------------------------------------------------64

Chapter 4- Radius-7 --------------------------------------------------------------------------66

Chapter 5- O3 Regional Oximetry----------------------------------------------------------67

Chapter 5- MOC-9 ----------------------------------------------------------------------------69

Using MOC-9 Ports -----------------------------------------------------------------------69

Chapter 7- Iris ---------------------------------------------------------------------------------71

Iris Status Screen --------------------------------------------------------------------------72

Using Iris Connectivity Ports ------------------------------------------------------------73

Chapter 8- Messages -------------------------------------------------------------------------75

Messages------------------------------------------------------------------------------------75

Chapter 9- Troubleshooting -----------------------------------------------------------------77

Troubleshooting Radical-7, Radius-7 and MOC-9 Modules ------------------------77

Troubleshooting Root ---------------------------------------------------------------------77

Chapter 10- Specifications-------------------------------------------------------------------81

Electrical ------------------------------------------------------------------------------------81

Environmental -----------------------------------------------------------------------------81

Display --------------------------------------------------------------------------------------82

Alarms --------------------------------------------------------------------------------------83

Nurse Call Specifications-----------------------------------------------------------------83

Connectors----------------------------------------------------------------------------------83

Wireless Specifications -------------------------------------------------------------------84

EMC Compliance -------------------------------------------------------------------------85

Software Compliance ---------------------------------------------------------------------86

Safety Standards Compliance ------------------------------------------------------------86

Guidance and Manufacturer's Declaration-Electromagnetic Emissions -----------87

Guidance and Manufacturer's Declaration-Electromagnetic Immunity ------------88

Recommended Separation Distances ---------------------------------------------------92

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Masimo

Root Contents

Symbols ------------------------------------------------------------------------------------ 94

Chapter 11- Service and Maintenance ---------------------------------------------------- 97

Cleaning ----------------------------------------------------------------------------------- 97

Replacing the Fuses ---------------------------------------------------------------------- 98

Power-On Self Test ---------------------------------------------------------------------- 98

Nurse Call Setting Connections -------------------------------------------------------- 98

Battery Test ------------------------------------------------------------------------------ 100

Repair Policy ----------------------------------------------------------------------------- 100

Return Procedure ------------------------------------------------------------------------ 101

Contacting Masimo --------------------------------------------------------------------- 101

Index ------------------------------------------------------------------------------------------ 105

Outside Back Cover ------------------------------------------------------------------------ 108

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Masimo

About this Manual

This manual explains how to set up and use Root. Important safety information relating to general use of Root appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes.

A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user.

WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to

avoid injury to the patient, damage to this instrument or damage to other property.

CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note.

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Masimo

Product Description, Features and Intended Use

Product Description and Features

Root is a patient monitoring and connectivity platform to transform care. It offers multiple high-impact innovations for broad applications across the continuum of care.

 Instantly interpretable, high-visibility display of Masimo’s breakthrough

SET® and rainbow® SET measurements from Masimo's Radical-7® Pulse CO-Oximeter (Radical-7) and the Radius-7™ Wearable Pulse COOximeter (Radius-7).

 Intuitive, touchscreen navigation for easy and adaptable use in any

hospital environment.

 Flexible measurement expansion through Masimo Open Connect (MOC-

9™).

 Designed for third-party measurement expansion to allow other companies

to add to the platform measurements.

 Built-in network connectivity gateway through Iris™ for standalone

devices such as IV pumps, ventilators, beds, and other patient monitors.

 Docking and charging station for Radical-7 and Radius-7 devices.

For all prescribing information and instructions for use of the compatible medical devices that are connected to Root, see Operator’s Manual or Instructions for Use for the specific medical device.

Intended Use

The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

Root can transmit data for supplemental remote viewing and alarming (e.g., at a central station).

Root can be used with the optional Radical 7, ISA product family and/or the SEDLine module.

Root is intended to be used with connected measurement modules compatible with Root interfaces.

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Masimo

Root Product Description, Features and Intended Use

Indications for Use

The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical 7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2

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

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

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care.The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

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

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Masimo

Root Product Description, Features and Intended Use

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.

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Masimo

Safety Information, Warnings and Cautions

CAUTION: Root® is to be operated by, or under the supervision of, qualified

personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. Refer to Operator’s Manuals of Patient Safety Net, Radical 7, Radius-7, ISA and SEDLine for additional safety information, warnings and cautions.

Safety Warnings and Cautions

WARNING: Do not use Root if it appears or is suspected to be damaged. WARNING: Do not adjust, repair, open, disassemble, or modify the Root. Injury to

personnel or equipment damage could occur.

WARNING: Do not start or operate the Root unless the setup was verified to be

correct.

WARNING: To ensure safety, only use Masimo authorized devices with Root. WARNING: Explosion Hazard: Do not use the Root in the presence of flammable

anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.

WARNING: To reduce the risk of explosion, only replace battery with Masimo

supplied parts.

WARNING: Fire Hazard: To protect against fire hazard, replace only with fuses of

same type, current rating, and voltage rating.

WARNING: Do not use the Root during magnetic resonance imaging (MRI) or in

an MRI environment.

WARNING: Do not remove the back panel of the device. This could cause injury to

personnel or device damage.

WARNING: Electrical Shock Hazard: To protect against injury, follow the

directions below:

 Avoid placing the device on surfaces with visible liquid spills.  Do not soak or immerse the device in liquids.  Do not attempt to sterilize the device.  Use cleaning solutions only as instructed in this Operator's

Manual.

 Do not attempt to clean the Root while monitoring patient.

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Masimo

Root Safety Information, Warnings and Cautions

WARNING: Electrical Shock Hazard: Injury to personnel could occur. Do not plug

in or remove the power cord with wet hands. Ensure that your hands are clean and dry before touching the power cord.

WARNING: When positioned on a flat surface, the device should be secured with a

mounting system recommended by Masimo.

WARNING: To ensure safety, avoid stacking multiple devices or placing anything

on the device during operation.

WARNING: Do not place the Root or accessories in any position that might cause

it to fall on the patient.

WARNING: As with all medical equipment, carefully route patient cabling to

reduce the possibility of patient entanglement or strangulation.

CAUTION: Do not place the Root where the controls can be changed by the

patient.

CAUTION: To ensure patient isolation, connect only Masimo devices that have

been designed for Root.

CAUTION: Equipment intended to be connected to signal input/signal output ports

should comply with applicable electrical safety standards to further minimize the risk of electric shock. Only devices that have been configured to operate with Root may function properly when connected.

CAUTION: Only use the AC power cable provided by Masimo. Using a different

AC power cable could cause damage to Root. Check the power cord and plug to ensure that it is intact and undamaged.

CAUTION: To avoid risk of electrical shock, this equipment must only be

connected to a supply mains with a protective earth connection. Do not under any circumstances remove the grounding conductor from the power plug.

CAUTION: Use a grounded outlet for proper equipment grounding. A hospital-

grade outlet is required.

CAUTION: Do not place Root where the appliance inlet or the AC power plug

cannot be readily disconnected.

Note: Disconnect the device from AC mains by removing the AC power cord

connector from the device inlet.

Note: If there is any doubt about the integrity of the protective earth conductor

arrangement, operate the Root on internal battery power until the AC power supply protective conductor is fully functional.

Note: Do not monitor more than a single patient at a time on Root.

Performance Warnings and Cautions

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Masimo

Root Safety Information, Warnings and Cautions

WARNING: Root may be used during defibrillation, but this may affect the

accuracy or availability of the parameters and measurements.

WARNING: Root may be used during electrocautery, but this may affect the

accuracy or availability of the parameters and measurements.

WARNING: Wireless communication of alarms to a secondary monitoring station

should not be relied upon as a primary alarm.

WARNING: Do not place the Root against a surface that may cause the alarm to be

muffled.

CAUTION: Ensure the speaker is not covered. CAUTION: Before using Root under high intensity surgical lights, confirm that the

display settings allow for clear display of measurements.

CAUTION: Do not connect to an electrical outlet controlled by a wall switch or

dimmer.

CAUTION: Do not place the Root on electrical equipment that may affect the

instrument, preventing it from working properly.

CAUTION: Failure to charge Root promptly after a Low Battery alarm may result

in the instrument shutting down.

CAUTION: To minimize radio interference, other electrical equipment that emits

radio frequency transmissions should not be in close proximity to Root.

CAUTION: If the Radical-7 or Radius-7 stops communicating with Root,

parameters and measurements will not show on the Root; however, this will not affect Radical-7's or Radius-7's ability to monitor the patient.

CAUTION: In order to establish and maintain Root’s minimum Quality of Service,

the following network specifications should be met before and after installation:

 Wired Network Connection

During Ping Test, passing result if:

a. At least 98% of packets have latency ≤ 30 milliseconds, and

b. No more than 2 % packets loss.

 Wireless Network Connection

During Ping Test, passing result if:

a. At least 98% of packets have latency ≤ 100 milliseconds,

b. No more than 2 % packets loss, and

c. Primary access point signal strength at least -67 dBm.

CAUTION: The wireless quality of services may be influenced by the presence of

other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless

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Masimo

Root Safety Information, Warnings and Cautions

PC and tablets, pagers, RFID, MRI electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength.

Note: The wireless communication status between Root and Patient SafetyNet is

displayed by Patient SafetyNet.

Note:Root is provided with a Wi-Fi signal indicator as an indication of Wi-Fi

communication.

Note: Root’s alarm capabilities have been designed to be independent of the Wi-Fi

communication feature in order to preserve Root’s primary alarms.

Note: Always charge Root when it is not in use to ensure that the battery remains

fully charged.

Cleaning and Service Warnings and Cautions

WARNING: Electrical Shock Hazard: The Root battery should be installed and/or

removed from Root only by qualified personnel.

WARNING: Do not use petroleum-based or acetone solutions, or other harsh

solvents, to clean the Root. These substances affect the device’s materials and instrument failure can result.

CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning

compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display.

CAUTION: Do not submerge the Root in any cleaning solution or attempt to

sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device.

CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn

off the device and disconnect from any AC power source.

CAUTION: An operator may only perform maintenance procedures specifically

described in the manual. Refer servicing to qualified service personnel trained in the repair of this equipment.

CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage

currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur.

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Masimo

Root Safety Information, Warnings and Cautions

Note: Excessive cleaning solution can flow into the device and cause damage to

internal components.

Compliance Warnings and Cautions

WARNING: Changes or modifications not expressly approved by Masimo shall

void the warranty for this equipment.

WARNING: Do not incinerate the battery. WARNING: In accordance with international telecommunication requirements, the

frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.

CAUTION: Consideration to the compliance of the IEC 60601-1 standard should

be made when configuring Root as part of a Medical System.

CAUTION: Disposal of Product: Comply with local laws in the disposal of the

instrument and/or its accessories.

Note: Use Root in accordance with the Environmental Specifications section in the

Operator's Manual.

Note: Cleared Use Only: The device and related accessories are cleared by the Food

and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the instructions for use or labeling.

Note: In accordance with international telecommunication requirements, the

frequency band of 2.4 GHz and 5.15 to 5.25 Ghz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.

Note: This device complies with Part 15 of the FCC Rules. Operation is subject to

the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Note: This equipment has been tested and found to comply with the limits for a

Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

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Masimo

Root Safety Information, Warnings and Cautions

 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 colocated or operating in conjunction with any other antenna or transmitter.

Note: This equipment has been tested and found to comply with the Class A limits

for medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments.

Note: This Class A digital apparatus complies with Canadian ICES-003. Note: Root is not intended for use during patient transport outside the healthcare

facility.

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Masimo

Chapter 1- Description

Root can be used in the following ways:

 As a docking station and charger for Radical-7 and Radius-7.  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

Docking Station

Root Display and

Touchscreen

Home Button Provides access to the Main Screen.

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

Provides an interface for user interactions.

Masimo

Root Chapter 1- Description

Ref. Feature Description

Root Charging

Indicator

AC Power

Indicator

Radical-7 Charging

Indicator

Shows an indication of the battery charge for Root.

Shows an indication of AC power connection Root.

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

Feature Description

Handle Allows the user to transport Root.

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Masimo

Root Chapter 1- Description

Feature Description

Speaker Provides audible notification.

Nurse Call

Connector

Ethernet Port

USB Ports (2) Provide USB 2.0 connectivity.

Power Entry

Module

Equipotential

Ground Connector

Iris Connectivity

Ports (4)

Provides a connection to a Nurse Call system.

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

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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Masimo

Root Chapter 1- Description

Side Views

Feature Description

System Status

Lights

Power Button Places Root in Power On, Standby and Power Off modes.

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

Provides an indication of alarms and system messages. See System Status Lights.

Right side Left side

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Masimo

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. Check all materials against the packing list. Save all packing materials,

invoice and bill of lading. These may be required to process a claim with the carrier.

3. Confirm that you have all components for the Root:

 Root  AC Power Cord

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

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.

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

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Masimo

Root Chapter 2- Setting Up

Power On

The Power Button can be used for Power On, Standby, 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.

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Masimo

Root Chapter 2- Setting Up

For information about Standby Mode and Power Off, See Standby and Power Off.

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 and About the Status Bar.

(1)

(2)

4. The Root Charging Indicator remains orange while the battery is charging and will illuminate green when Root is fully charged. See Root Battery and About the Status Bar.

See Safety Informations, Warnings and Cautions.

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Masimo

Root Chapter 2- Setting Up

Radical-7 Connection

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

 Snap the Radical-7 into the Docking Station.  If the Radical-7 is not yet turned on, press the power button on the

Radical-7 to power it on.

 When properly connected, the Radical-7 Charging Indicator light will

illuminate. An illuminated Radical-7 Battery icon will also appear in the Status Bar.

 Root display will show active measurements and parameters.

For Radical-7 charging conditions, see Radical-7 Charging Indicator.

Nurse Call Connection

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

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Masimo

Root Chapter 2- Setting Up

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 Output.

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Masimo

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 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

Alarm

Silence

Audio

Pause

Profiles

Bluetooth

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Displays alarm status and mutes all audible alarms for Root, Radical-7, Radius-7 and MOC-9 modules.

See Alarm Silence.

Displays Audio Pause status and temporarily silences an alarm event.

See Audio Pause.

Provides access to the Profiles screen. The example shown illustrates that Profiles is currently set to Adult for an adult patient.

See Profiles.

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

See Bluetooth.

Masimo

Root Chapter 3- Operation

Ref. Feature Description

Provides access to the Wi-Fi screen. If this icon is visible, then

Wi-Fi

Ethernet

Iris

Radical-7 Battery

Wi-Fi connectivity has been enabled. The icon itself also indicates the strength of the wireless signal.

See Wi-Fi.

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

See Ethernet

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 Connectivity Gateway.

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

Displays charging status for Radical-7 and provides access to the Battery Radical screen. The example shows that the battery is currently charging.

See Radical-7 Charging Indicator.

Displays charging status for Root and provides access to the

Root

Battery

Sounds

Current

Time

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

See Root Charging Indicator.

Provides access to the Sounds screen to adjust alarm and pulse tone volume. This icon does not indicate the actual volume level of the alarm and pulse tone.

See Sounds.

Displays the current time and provides access to the Localization screen which contains settings related to local time, language and geography.

See Localization.

Masimo

Root Chapter 3- Operation

About the Main Screen

The Main Screen consists of several features. The following shows the Main Screen when three different devices are connected, Radical-7 (top) showing rainbow® parameters and measurements, Phasein module (middle) showing capnography measurements and SedLine module (bottom) showing brain function measurements.

Ref. Feature Description

Status Bar

Windows

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

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

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Masimo

Root Chapter 3- Operation

Ref. Feature Description

Main Menu icon

Provides access to the configuration options for Root and connected medical devices. See Accessing Main Menu Options

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Masimo

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

Touch and release. Action

Press

Slide

performed once finger is released.

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

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.

Control Applicable Actions Description

Toggle Slide knob Switches between toggle states

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See Customizing

Windows.

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.

Masimo

Root Chapter 3- Operation

Control Applicable Actions Description

Press left or right of toggle

Labeled Toggle

Spinner Press center

Slider Slide knob Moves knob

Slide knob Switches between toggle states

Press left or right of toggle

Press label Quickly moves knob left or right

(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

Press anywhere along slider path

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

Slider Spinner Slide knob Moves knob

Press anywhere along slider path

Press center (focused) tile

Swipe up/down When open, scrolls through spinner tiles

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

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Quickly moves knob to Tap position

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

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Control Applicable Actions Description

position

Press anywhere outside spinner

Button Press Performs action (as defined by the button

Icon Menu Press tile Opens menu specified by tile

Swipe left or right (anywhere)

Press bottom indicator icon

Window Press parameter or

measurement

Press and hold Enables parameter and measurement drag

Well Press parameter or

measurement

When open, collapses spinner

description)

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

and 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

Press and hold Enables parameter and measurement drag

and drop

Live Swipe down Separates pleth and acoustic waveforms

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Control Applicable Actions Description

Waveform

Swipe up Combines pleth and acoustic waveforms

Trend Line Pinch in Zooms in

Pinch out Zooms out

Pan Changes time range

Press y-axis Opens parameter or measurement trend

Trend Zoom Press '+' Increases time range

Press '-' Decreases time range

Press time label Resets time range to default

Alarm Silence

Press Silences all alarms

icon

Audio Pause

Press Enables Audio Pause

icon

Other Status

Press Opens relevant menu

Bar icons

Back Arrow Press Exits menu, abandons any changes

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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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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 instructions for use or Operator's Manual of Radical-7, Radius-7 and MOC-9 modules.

Trend View

Feature Description

Window

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

Drop Down

Settings Menu

Waveform

Shows a parameter or measurement over time (only for Radical7, Radius-7 and MOC-9 modules).

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Analog View

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Root Chapter 3- Operation

Feature Description

(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. Using Trend

Trend Display

View.

(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

Analog Gauge

Ranges. See Using Analog View.

5 Well

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

Using Trend View

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

over time. If a Window supports Trend View, then in the upper right corner. Press the icon to view parameter or measurement data in Trend View.

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

Feature Description

Indicates current viewing of the parameter or measurement.

Value Range

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

(Trend View icon) displays

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Feature Description

Trend Line

Numeric Value Indicates current reading of the parameter or measurement.

Alarm Limits

Parameter or

Measurement Label

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

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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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 instructions for use or operator's manuals for Radical-7,Radius-7 and the appropriate MOC-9 module(s).

If a Window supports Analog View, then upper right corner. Press the icon to view parameter and measurement data in Analog View.

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

Needle

Alarm Limits

Indicates current status of a parameter or measurement.

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

(Analog View icon) displays in the

Numeric Value

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Indicates current reading of the parameter or measurement

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Root Chapter 3- Operation

Ref. Feature Description

Parameter or

Measurement Label

Indicates the name of the parameter or measurement.

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Specific ranges of the Analog View are:

Ref. Feature Color Description

Normal Range White

Caution Range Yellow

Alarming

Range

Red

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

Area of the display range that provides a caution indicator.

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 SpO2 gauge is shown as a quarter circle, where values lower than 88% will trigger an alarm, and the PR gauge is shown as a half circle, where values below 50 bpm and above 140 bpm will trigger an alarm.

Quarter Circle Half Circle

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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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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.

Accessing Main Menu Options

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

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The Main Menu options are:

Device Settings

See Device Settings.

About

See About.

Trend Settings

See Trend Settings.

Profiles

See Profiles.

Iris

See Iris.

Layout

See Layout.

Sounds

See Sounds.

Device Settings

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

The Device Settings options are:

Localization

See Localization.

Wi-Fi

See Wi-Fi

Ethernet

See Ethernet.

Bluetooth

See Bluetooth.

Root Battery

See Root Battery

Radical-7 Battery

See Radical-7 Battery.

Brightness

See Brightness.

Access Control

See Access Control.

Device Output

See Device Output

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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.

Option Description Factory Default

Setting

Language

Date Format

Time

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

Configurable Settings

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

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

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Root Chapter 3- Operation

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.

Option Description Factory Default

Setting

Wi-Fi

Enables or disables Wi-Fi connectivity.

Off On or Off

Configurable Settings

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 on Patient SafetyNet, see Operator's Manuals of Patient SafetyNet.

Ethernet

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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.

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

Option

Bluetooth

Description Factory Default

Setting

Enables or disables Bluetooth connectivity.

Off On or Off

Configurable Settings

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

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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.

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 Battery

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

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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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

Brightness

Root display by sliding the button

4 1, 2, 3, 4

(4 is brightest).

Access Control

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

To enter Access Control

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1. Press the

key.

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

Asterisks (****) will be displayed.

To undo an entry, press Backspace.

3. Press Enter to access the password protected screen.

Note: The password will have to be entered every time this screen is accessed.

Option Description Factory

Default

Configurable Settings

Setting

All Mute Enabled

Lock Alarm Volume

Save as Adult

Save as Pediatric

Save as Neo

Enable parameter Alarm Silence menu option. See Sounds.

Sets the lowest alarm volume level.

Saves current profile parameter as the Adult Profile.

Saves current profile parameter as the Pediatric Profile.

Saves current profile parameter as the Neonatal Profile.

Off On or Off

Off 3, 4, or Off

N/A

Press Save to

load.

Press Save to

load.

Press Save to

load.

Factory Defaults

Options are restored to factory values.

Device Output

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N/A Press Restore.

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Root Chapter 3- Operation

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

Controls the mechanism of

Nurse Call Polarity

action for triggering to occur. Should be changed to accommodate institutional Nurse

Normal Normal or Inverted

Call settings.

Nurse Call Trigger

Controls the source of monitoring which sets off the trigger.

Alarms

Port 0 None

Port 1 IAP

SpecTable Radical

Configurable Settings

Alarms, Signal IQ Alarms, and Signal IQ

None, IAP, IntelliBridge, and ASCII 1

Radical, Radical Module A, Sedline, and Sedline Numerics Only

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.

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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.

Information about Radical-7, Radius-7 and MOC-7 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

Clear Trends

Duration captured by Trend Lines.

Delete all stored trend data.

2 hours

N/A

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Configurable Settings

15, 30, 45 minutes

1, 2, 4, 8, 12, 24 hours

Press Clear to delete all

stored trend data.

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To configure trend settings of specific parameters and measurements, see Instructions 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

Patient Type

Identifies the Profiles setting in the device.

Adult

Configurable Settings

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.

Custom profiles can also be created to accommodate usage in any hospital care area. See the Masimo Instrument Configuration Tool Directions for Use for information on adding Profiles.

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).

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.

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Layout

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

Additional Settings

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

Note: This feature only applies to Trend View. See Using Trend View.

Option

Layout Style

Description Factory Default

Setting

Controls the sizing of Trend Displays.

Fixed Fixed or Dynamic

Configurable Settings

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

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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.

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.

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.

Available Layout

When only Radical-7,Radius-7 or a single MOC-9 module is connected to Root, the Available Layout will be 100%. When Radical-7 and/or multiple devices are connected, the user will have the option to select from several pre-configured layouts.

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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

Audio Pause Duration

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

2 minutes

will be no audible alarms, 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.

*Requires user to have All Mute Enabled (Permanent Silence Duration) in the Access Control menu. See Access Control.

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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

1 Five (5) beeps: beep-beep-beep, brief pause, beep-beep

2 Three (3) beeps: beep-beep-beep

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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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 red, 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 Instructions for Use or Operator’s Manuals for Radical-7,Radius-7 and MOC-9 modules.

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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.

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

Yes

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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.

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

Audio Pause inactive

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 117 seconds left until Audio Pause is inactivated again.

To configure Audio Pause, see Sounds.

Audio Pause active. 117 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.

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.

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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

System Status Light

Light Status Alarm Priority Indication

None None Monitoring has not begun.

Green None There is currently no active alarms.

Yellow Low There is an active alarm of low priority.

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 Low

Service required High

AC Power Indicator

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Whenever Root is connected to an AC power source, this light will illuminate:

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

Battery Indication

Status

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.

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Root Chapter 4- Radius-7

Standby and Power Off

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

State Description

Press and hold the Power Button for two (2) seconds until one (1)

Standby Mode

audible tone sounds.

Standby 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

Power Off

Button will flash orange.

Mode

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

Chapter 4- Radius-7

The Radius-7 is a patient wearable device for continuous monitoring when the patient is ambulatory. It measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and Pleth Variability Index (PVI®) along with Acoustic Respiration Rate (RRa®). It uses a Bluetooth or Wi-Fi connection to transfer parameter data to Root. When Radius-7 is connected to Root via Bluetooth or Wi-Fi, 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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Masimo

Root Chapter 5- O3 Regional Oximetry

Chapter 5- O3 Regional Oximetry

The O3 system is a patient-connected, noninvasive oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation in the tissue (rSO2), including cerebral tissue. It can be used in any hospital and hospitaltype facility where rSO2 measurements might improve patient outcomes.

The Masimo O3 Regional Oximeter and Sensors are indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue below the sensor in hospital and hospital-type facilities. See the O3 Operator's Manual for more information.

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Masimo

Chapter 5- MOC-9

Flexible measurement expansion is enabled through MOC-9. It can display parameters and measurements captured by 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 Phasein 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

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on Root.

Masimo

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

5 Root

6 Radical-7

7 MOC-9 modules

8 Patient SafetyNet or Masimo Connectivity Gateway

9 Electronic Health Records system

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Root Chapter 7- Iris

Iris Status Screen

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

Connection

Description of Connection

Status Color

Standalone device is successfully connected to Root, and Root is

Green

successfully connected to a Patient SafetyNet or Connectivity Gateway.

Standalone device is successfully connected to Root; however,

Yellow

Root is not successfully connected to a Patient SafetyNet or Connectivity Gateway.

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

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)

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Port 2

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Root Chapter 7- Iris

Port 3 Port 4

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.

Port 1

Port 2

Port 3

Port 4

To connect a standalone device via an Iris Connectivity Port:

1. Connect the RS-232 end of the Iris Adapter to the standalone device.

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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Masimo

Chapter 8- Messages

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 Radical7, 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, Radius7 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.

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The battery may be depleted.

One of the fuses is not operating properly.

The brightness setting is not correct.

Internal Failure

Connection error.

Connect Root to AC power to charge battery.

Replace the fuse. See Replacing the Fuses.

Adjust the brightness setting. See Brightness.

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

Root requires service. Contact Masimo Technical Support. See Return Procedure.

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 Wi-Fi or 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.

Connection error Unplug and replug the Iris Adapter.

If the problem persists, refer to instructions for use or operator's manual

Connection error.

Internal failure.

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

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.

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

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

Internal failure.

Home Button does not work when pressed.

Battery does not charge.

Root Charging Indicator illuminates red.

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Internal failure.

AC power cable may be disconnected.

Internal failure.

Root requires service. See Return Procedure.

Unplug and replug AC power cable.

Root requires service. See Return Procedure.

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Root Chapter 9- Troubleshooting

Symptom Possible Cause Correction

Nurse Call does not communicate.

Connection error

Unplug and replug Nurse Call connector.

See Nurse Call Setting Connections

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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 Instructions for Use or Operator's Manuals for these devices.

Electrical

Root

AC Power requirements

Fuses (2)

100-240 VAC~, 47-63 Hz, 65 W (Max)

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

Battery

Type 10.8V Lithium Ion (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

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Root Chapter 10- Specifications

Root

Storage Humidity 10% to 95%, non-condensing

500 mbar to 1060 mbar

Operating Altitude

-1000 ft to 18,000 ft

(-304 m to 5,486 m)

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

Characteristic Description

Type Multi-Touch P-Cap

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Alarms

Visual Alarm Priority System Status Light Color

High Red

Low Yellow

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

Wireless Specifications

Communication (Wi-Fi)

Type WLAN Radio: IEEE 802.11 a/b/g

Frequency

Max Peak Output Power WLAN 17 dBm

Classification of Output Power Rating

Output Power Type Fixed at the Factory

Modulation Types OFDM, BPSK, CCK

Modulation Signals Analog and Digital

Available Data Rates

Communication (Bluetooth)

Type Bluetooth

Frequency 2402-2480 MHz

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

802.11b/g: 2412-2462 MHz

Conducted

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

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

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

Max Peak Output Power Bluetooth 1.3 dBm

Classification of Output Power Rating

Output Power Type Fixed at the Factory

Modulation Types DH5

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Conducted

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Root Chapter 10- Specifications

Communication (Wi-Fi)

Modulation Signals Analog and Digital

Available Data Rates Bluetooth 1 Mbps

Security and Authentication

Encryption

Authentication

64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2AES

Open System, Shared Key, Pre-Shared Key (PSK),

802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST

Radio Compliance

USA FCC ID: VKF-RDS7A

Model - RDS7A

Canada IC:7362A-RDS7

IC Model: RDS7A

RSS-210

Europe

EN 300 328

EN 301 489-17

R & TTE Directive

EMC Compliance

EN 60601-1-2, Class A device

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Software Compliance

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

Safety Standards Compliance

Protection from Ingress of Liquids

IPX1 per IEC 60529

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

ISO 9919:2005

IEC-60601-2 - 49:2001

Type of Protection

Class I (on AC power)

Internally powered (on battery power)

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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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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

Test Level

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/burst

IEC 61000-4-4

+6 kV contact

+8 kV air

+2 kV for power supply lines.

+1 kV for input/output lines.

Surge

IEC 61000-4-5

+1 kV differential mode

+2 kV common mode

Compliance Level

+6 kV contact

+8 kV air

-- Mains power quality should be

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%.

that of a typical commercial or hospital environment.

that of a typical hospital environment.

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

IEC 61000-4-11

Power frequency (50 / 60 Hz) magnetic field.

IEC 61000-4-8

Conducted RF

IEC 61000-4-6

100% for 0.5 cycle

60% for 5 cycles

30% for 25 cycles

100% for 5 seconds

-- Mains power quality should be that of a typical commercial or hospital environment. Root provides a battery for continued operation during power mains interruption for a maximum of 4 hours.

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

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

3 Vrms

150 kHz to 80 MHz

3 Vrms

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Root Chapter 10- Specifications

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to

2.5 GHz

3 V/m Portable and mobile RF

communications equipment should be 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

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 range

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

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Root Chapter 10- Specifications

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.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ME Equipment is used exceeds the applicable RF compliance level above, the ME Equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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Recommended Separation Distances

Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment

The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME Equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ME Equipment as recommended below, according to the maximum output power of the communication equipment.

Rated maximum output power of transmitter (W)

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.7 3.7 7.37

100 11.7 11.7 23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

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.

Separation Distance According to Frequency of Transmitter (m)

150 K Hz to 80 MHz

d = 1.17*Sqrt (P)

80 MHz to 800 MHz

d = 1.17*Sqrt (P)

800 MHz to

2.5GHz

d = 2.33*Sqrt (P)

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Symbols

The following symbols are found on Root or its packaging and are defined below. Some of the interfaces and symbols are not available on all versions.

Symbols Definition Symbols Definition

Follow Instructions for Use

Manufacturer

Date of Manufacture

Non-ionizing Electromagnetic Radiation

IPX1 Protection Against Liquid Drops Falling Vertically

Federal (USA) Law Restricts this Device to Sale by Or on the Order of a Physician

UL, LLC, Certification

Separate Collection for Electronic Waste

Storage Temperature Limitation

Storage Altitude Limitation

Storage Humidity Limitation

Keep Dry

Fragile/Breakable, Handle with Care

Fuse Replacement. See Replacing the Fuses section of the Operator's Manual.

Equipotential Ground Terminal

Federal Communications Commission (FCC) licensing

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Iris Connection

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Root Chapter 10- Specifications

Symbols Definition Symbols Definition

FCC ID,

Identifies Unit has been

IC,

Registered as a Radio Device

USB port

Model

Mark of Conformity to European Medical Device Directive 93/42/EEC

AC Current

Authorized representative in the European community

Nurse Call Interface

Wireless Features Can be Used in Member States with the restriction of indoor use in France

Defibrillation Proof Type BF

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Chapter 11- Service and Maintenance

This chapter contains information about cleaning, battery operation, performance verification, service, repair and warranty.

Cleaning

Root is a non-sterile and reusable device. The surface of the Root should be cleaned when the device is visibly dirty, before and after each procedure, and/or according to hospital practice.

To surface clean, wipe down the outer surface of Root using any of the following solvents:

 Cidex Plus (3.4% glutaraldehyde)  10% bleach solution  70% isopropyl alcohol solution

Do not allow liquids to enter the interior of Root. Using the recommended cleaning solutions on the touchscreen will not affect the performance of Root.

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Root Chapter 11- Service and Maintenance

Replacing the Fuses

If a power-related problem causes one or both of the fuses to fail, the fuse(s) will need to be replaced. Replace fuse(s) with UL Listed fuses rated fast-acting, 250V, 2 amp, metric, 5x20 mm and with a breaking capacity of minimum 1500A.

WARNING: To ensure safety, only replace with appropriately rated fuses.

The fuses can be removed by hand or with a 5-millimeter or 3/16-inch screwdriver.

To replace the fuse(s)

1. Power Off Root completely. Do not put in Standby Mode. See Standby

and Power Off.

2. Remove the AC power cord from the Power Entry Module in the back

panel.

3. Remove the fuse holder by pulling it forward from the Power Entry

Module.

4. Remove a fuse by gently pulling the top of the fuse away from the center

and then pulling up. The fuse should easily be removed. Do not force.

5. Place a new fuse in the fuse holder.

6. If replacing both fuses, repeat steps 4 and 5 for the second fuse.

7. Slide the fuse holder back into the Power Entry Module and press firmly

to make sure it is secure.

Root is ready to be reconnected to AC power. If the fuses fail shortly after replacement, Root requires service. See Repair Policy.

Power-On Self Test

To conduct a Power-On Self Test

1. Connect Root to AC power, and verify that the AC Power Indicator is

illuminated.

2. Power On Root. Within five (5) seconds, all available indicators will

illuminate, the device will emit a tone, and the Masimo logo will display.

Nurse Call Setting Connections

For maximum flexibility, either normally open or normally closed signals are available. During an alarm condition or a low Signal IQ event, depending on the configuration of the device output, the normally open pin will be connected to the common pin and the normally closed pin will be disconnected. In addition, the

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Masimo RDS7A User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual