Root Operators 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:VKF-RDS7A IC:7362A-RDS7A IC Model: RDS7A Masimo Corporation 52 Discovery 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 3149433

Conforms to ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1, and applicable Particular (IEC 60601-2-49, ISO 80601-2-56) and related Collateral (IEC 60601-1-8:2006) Standards for which the product has been found to comply by Intertek.

Patents: www.masimo.com/patents , Iris, Masimo, MOC-9, PVi, Radical-7, Radius-7, rainbow, Root, RRa, SedLine, SET, Signal Extraction Technology, SpCO, SpHb, and SpMet are federally registered trademarks of Masimo Corporation. ISA, MyView, and SpOC are trademarks of Masimo Corporation. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. All other trademarks and registered trademarks are property of their respective owners. © 2018 Masimo Corporation

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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 Masimo Kite --------------------------------------------------------------------------------------------- 27 Bluetooth Devices -------------------------------------------------------------------------------------- 27 Chapter 3: Operation -------------------------------------------------------------------------------------- 29 About the Main Screen -------------------------------------------------------------------------------- 29 About the Status Bar --------------------------------------------------------------------------------- 30 About the Action Bar ---------------------------------------------------------------------------------- 32 Using the Touchscreen Interface ------------------------------------------------------------------- 33 Menu Navigation -------------------------------------------------------------------------------------- 36 Understanding Windows----------------------------------------------------------------------------- 38 www.masimo.com

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Contents

Accessing Main Menu Options ---------------------------------------------------------------------- 46 Alarm Interface----------------------------------------------------------------------------------------- 63 Trend Download ---------------------------------------------------------------------------------------- 68 Session Management --------------------------------------------------------------------------------- 68 Screen Capture ----------------------------------------------------------------------------------------- 69 Lights ---------------------------------------------------------------------------------------------------- 71 Chapter 4: Admit and Discharge to Patient SafetyNet---------------------------------------------- 75 Not Admitted ------------------------------------------------------------------------------------------- 75 Admitting a Patient ----------------------------------------------------------------------------------- 76 Discharging a Patient --------------------------------------------------------------------------------- 77 Not Monitoring Message ----------------------------------------------------------------------------- 79 Monitoring Resumed Message---------------------------------------------------------------------- 80 Chapter 5: Electronic Medical Record (EMR) Push -------------------------------------------------- 81 Determining EMR Push is Active -------------------------------------------------------------------- 81 Manually Entering Patient Data --------------------------------------------------------------------- 81 Sending Patient Data to the EMR ------------------------------------------------------------------- 82 Chapter 6: Radical-7 -------------------------------------------------------------------------------------- 83 Chapter 7: Radius-7---------------------------------------------------------------------------------------- 85 Chapter 8: MOC-9 ----------------------------------------------------------------------------------------- 87 Using MOC-9 Ports ------------------------------------------------------------------------------------ 87 Chapter 9: Iris ---------------------------------------------------------------------------------------------- 89 Using Iris Connectivity Ports ----------------------------------------------------------------------- 90 Iris Icon -------------------------------------------------------------------------------------------------- 91 Iris Screen ----------------------------------------------------------------------------------------------- 92 Chapter 10: Bluetooth Devices -------------------------------------------------------------------------- 95 Connect Device to Root ------------------------------------------------------------------------------- 95 Chapter 11: Messages ------------------------------------------------------------------------------------- 97 Chapter 12: Troubleshooting ---------------------------------------------------------------------------- 99 Troubleshooting Radical-7, Radius-7, and MOC-9 Modules ------------------------------------- 99 Troubleshooting Root --------------------------------------------------------------------------------- 99 Chapter 13: Specifications ----------------------------------------------------------------------------- 103 Alarms ------------------------------------------------------------------------------------------------- 103 Nurse Call Specifications --------------------------------------------------------------------------- 103 www.masimo.com

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Contents

Connectors -------------------------------------------------------------------------------------------- 103 Electrical ----------------------------------------------------------------------------------------------- 104 Environmental ---------------------------------------------------------------------------------------- 104 Touchscreen Display --------------------------------------------------------------------------------- 105 Wireless Specifications------------------------------------------------------------------------------ 105 Compliance-------------------------------------------------------------------------------------------- 107 Guidance and Manufacturer's Declaration-Electromagnetic Emissions -------------------- 108 Guidance and Manufacturer's Declaration-Electromagnetic Immunity -------------------- 109 Recommended Separation Distances ------------------------------------------------------------- 111 Symbols ------------------------------------------------------------------------------------------------- 112 Chapter 14: Service and Maintenance --------------------------------------------------------------- 115 Cleaning ----------------------------------------------------------------------------------------------- 115 Replacing the Fuses --------------------------------------------------------------------------------- 115 Power-On Self Test ----------------------------------------------------------------------------------- 115 Nurse Call Setting Connections ------------------------------------------------------------------- 116 Battery Test ------------------------------------------------------------------------------------------- 116 Repair Policy ------------------------------------------------------------------------------------------ 116 Return Procedure-------------------------------------------------------------------------------------- 117 Masimo Technical Services-------------------------------------------------------------------------- 117 Contacting Masimo ----------------------------------------------------------------------------------- 117 Index -------------------------------------------------------------------------------------------------------- 121

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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® and rainbow® SET measurements.

•

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

•

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

•

Designed for third-party measurement expansion to allow other companies to add to the platform measurements.

•

Built-in network connectivity gateway through Iris® for standalone devices such as IV pumps, ventilators, beds, and other patient monitors.

•

Docking and charging station for Radical-7® and Radius-7® Battery Module.

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Ability to display data on a secondary display.

•

Ability to display data from external devices using Bluetooth.

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

Intended Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station). The Masimo Root Monitoring System can be used with the optional Radical-7, ISA product family, Radius-7, and/or the SedLine module. The Masimo Root Monitoring System is intended to be used with connected measurement modules compatible with Root interfaces.

Indications for Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation www.masimo.com 9 Masimo

Root

Product Description and Features, Intended Use and Indications for Use

(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 noninvasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices. The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases: ISA CO2: CO2 ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA 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 There are no contraindications.

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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. www.masimo.com 11 Masimo

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. www.masimo.com

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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. www.masimo.com

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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.

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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

1

Docking Station

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

2

Root Display and Provides a frontal display and interface for user interactions. Touchscreen

3

Home Button

Provides access to the Main Screen.

4

Root Charging Indicator

Shows an indication of the battery charge for Root.

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Chapter 1: Description

Ref. Feature

Description

5

AC Power Indicator

Shows an indication of AC power connection Root.

6

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.

3

Nurse Call Connector

Provides a connection to a Nurse Call system.

4

Ethernet Port

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

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Root

Chapter 1: Description

Ref. Feature

Description

5

USB Ports (2)

Provide USB 2.0 connectivity.

6

Power Entry Module

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

7

Equipotential Ground Connector

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.

8

Iris Connectivity Ports (4)

Provide connection for standalone devices.

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Root

Chapter 1: Description

Side Views

Left Side Ref. Feature

Right Side

Description

1

System Status Lights

Provides an indication of system messages and alarm priority. See System Status Lights on page 71.

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. 2.

Remove Root from the shipping carton and examine it for signs of shipping damage or exposed electronics. 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 117.

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 104.

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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 73. www.masimo.com

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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 72 and About the Status Bar on page 30.

(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 on page 55 and About the Status Bar on page 30.

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

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