Masimo RDS7 User Manual

Root™

Operator's Manual

Wireless Radio

IC:7362A-RDS7

IC Model: RDS-7

FCC ID: VKF-RDS7

Model - RDS-7

Masimo Corporation 40 Parker Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com

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

Root operating instructions provide the necessary information for proper operation of 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 the instructions in this manual.

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

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.

EU authorized representative for Masimo Corporation:

MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

The use of the trademarks PATIENT SAFETYNET and PSN is under license from University HealthSystem Consortium.

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

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Contents

About this Manual ---------------------------------------------------------------------------- 7 Product Description and Intended Use ------------------------------------------------- 9

Product Description ---------------------------------------------------------------------- 9 Intended Use ------------------------------------------------------------------------------ 9

Safety Information, Warnings, and Cautions---------------------------------------- 11

Safety Information, Warnings, and Cautions ------------------------------------ 11 General Information, Warnings and Cautions ----------------------------------- 12 Compliance Information, Warnings and Cautions ------------------------------ 13 Electrical Information, Warnings and Cautions --------------------------------- 15

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 Nurse Call Connection Port ---------------------------------------------------------- 24

Chapter 3: Operation ---------------------------------------------------------------------- 27

About the Main Screen ---------------------------------------------------------------- 28 About the Status Bar ------------------------------------------------------------------- 29 Using the Touchscreen Interface --------------------------------------------------- 31 Menu Navigation ------------------------------------------------------------------------ 34 Understanding Windows -------------------------------------------------------------- 35 Accessing Main Menu Options ------------------------------------------------------ 43 Device Settings ------------------------------------------------------------------------- 44 About -------------------------------------------------------------------------------------- 53

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Root Contents

Trend Settings --------------------------------------------------------------------------- 53 Profiles ------------------------------------------------------------------------------------ 54 Iris ------------------------------------------------------------------------------------------ 54 Layout ------------------------------------------------------------------------------------- 55 Sounds ------------------------------------------------------------------------------------ 57 Alarm Interface -------------------------------------------------------------------------- 58 Trend Download ------------------------------------------------------------------------ 62 Lights -------------------------------------------------------------------------------------- 63

Chapter 4: MOC-9 ------------------------------------------------------------------------- 67

MOC-9 Ports ----------------------------------------------------------------------------- 67

Chapter 5: Iris ------------------------------------------------------------------------------- 69

Iris Connection Ports ------------------------------------------------------------------ 70

Iris Status Screen----------------------------------------------------------------------- 71 Chapter 6: Messages --------------------------------------------------------------------- 73 Chapter 7: Troubleshooting ------------------------------------------------------------- 75

Troubleshooting Radical-7 and MOC-9 Modules ------------------------------- 75

Troubleshooting Root------------------------------------------------------------------ 75 Chapter 8: Specifications ---------------------------------------------------------------- 79

Electrical ---------------------------------------------------------------------------------- 79

Environmental --------------------------------------------------------------------------- 79

Display ------------------------------------------------------------------------------------ 80

Alarms ------------------------------------------------------------------------------------- 80

Nurse Call Specifications ------------------------------------------------------------- 81

Connectors ------------------------------------------------------------------------------- 81

Communication Specifications ------------------------------------------------------ 81

Applicable Standards and Regulations ------------------------------------------- 82

Symbols ----------------------------------------------------------------------------------- 84 Chapter 9: Service and Maintenance ------------------------------------------------- 87

Cleaning ---------------------------------------------------------------------------------- 87

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Root Contents

Replacing the Fuses ------------------------------------------------------------------- 88 Power-On Self Test -------------------------------------------------------------------- 88 Nurse Call Setting Connections----------------------------------------------------- 88 Battery Test ------------------------------------------------------------------------------ 90 Repair Policy ----------------------------------------------------------------------------- 90 Return Procedure ----------------------------------------------------------------------- 91 Contacting Masimo --------------------------------------------------------------------- 91 Sales & End-User License Agreement -------------------------------------------- 92 Warranty ---------------------------------------------------------------------------------- 92 Exclusions -------------------------------------------------------------------------------- 93 Restrictions ------------------------------------------------------------------------------- 93

Index ------------------------------------------------------------------------------------------ 95

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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 the product 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 and, death) to the patient or user. The following is an example of a warning:

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 Root or damage to other property. The following is an example of a caution:

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

following is an example of a note: Note: This is an example of a note.

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Product Description and Intended Use

Product Description

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 rainbow® and SET® measurements from Masimo's Radical-7® handheld monitor

 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 connectivity gateway through Iris™ for standalone devices

Intended Use

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

Root is a docking station for the Radical-7 handheld monitor. It is also a platform device intended for use with MOC-9 modules. Root is intended to be used in hospitals and hospital-type facilities. It is not intended for home use.

For all prescribing information and instructions for use of the compatible

medical technologies, refer to the operator’s manual or instructions for use for

the specific medical technology.

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Safety Information, Warnings, and Cautions

The following section lists warnings, cautions, notes, and safety information for Root.

Root is to be operated by qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use.

Safety Information, Warnings, and Cautions

WARNING: Do not use Root if it appears to be damaged. Contact your biomedical engineering department for guidance before using Root.

WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the instrument during operation.

WARNING: Do not place Root or accessories in any position that might cause it to fall on the patient.

WARNING: Do not use Root during magnetic resonance imaging (MRI). 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: Replace only with fuses of same type, current rating, and voltage rating.

WARNING: Do not adjust, repair, open, disassemble or modify Root. 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 device.

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

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

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Root Safety Information, Warnings, and Cautions

General Information, Warnings and Cautions

WARNING: When placed on a flat surface, the device should be secured with a mounting system recommended by Masimo.

WARNING: Do not touch, press or rub the touchscreen with abrasive cleaning compounds, instruments, brushes or rough-surface materials, or bring them into contact with anything that could scratch the touchscreen.

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

other harsh solvents to clean Root. These substances affect the device’s

materials, and device failure can result.

CAUTION: Ensure that the speaker is not covered. CAUTION: Do not place Root against a surface that may cause the alarm to

be muffled. CAUTION: Should the Radical-7 and Root become unable to communicate,

parameters and measurements will not show on the Root display. This will not affect Radical-7's ability to monitor the patient.

Note: Root is not intended for use during patient transport outside the healthcare facility.

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

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Root Safety Information, Warnings, and Cautions

Compliance 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: Disposal of product: Comply with local laws in the disposal of the instrument and/or its accessories.

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 FDA or other applicable regulatory authorities, or in any manner inconsistent with the instructions for use or labeling.

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. The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment.

Note: This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class A. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

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 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.

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Root Safety Information, Warnings, and Cautions

Note: This Class A digital apparatus complies with Canadian ICES-003. Note: Use Root in accordance with Environmental Specifications section in

this manual.

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Root Safety Information, Warnings, and Cautions

Electrical Information, Warnings and Cautions

WARNING: Root may be used during electrocautery, but this may affect the accuracy or availability of the parameters and measurements.

WARNING: Root may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements.

WARNING: Electrical shock hazard: Do not remove the back panel of the device. This could cause injury to personnel or device damage.

WARNING: Electrical shock hazard: The battery should be installed and/or removed from Root by qualified personnel only.

WARNING: Risk of explosion if battery is replaced with an incorrect type. Replace with Masimo supplied parts only.

WARNING: Do not incinerate the battery. CAUTION: To ensure patient electrical isolation, connect only to medical

technologies with electrically isolated circuits. CAUTION: To minimize radio interference, other electrical equipment that

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

CAUTION: 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.  Use cleaning solutions only as instructed in this operator's manual.

See Cleaning on page 87.

CAUTION: 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.

CAUTION: Electrical shock and flammability hazard: Before cleaning Root, always turn it off and disconnect the power cord from the AC power supply.

CAUTION: If Root has not been used or charged within seven (7) days or more, then recharge the battery prior to use.

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Root Safety Information, Warnings, and Cautions

CAUTION: Do not under any circumstances remove the grounding conductor from the power plug.

CAUTION: Do not use extension cords or adapters of any type. 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: Use a grounded outlet for proper grounding. A hospital-grade outlet is required.

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

CAUTION: Failure to plug in the AC power cable promptly after a low battery message may result in the device shutting down.

Note: Disconnect the instrument using the AC power cord connector. 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. 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.

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Ref.

Feature

Description

Docking Station

Provides a docking station for the Radical-7. While docked, the Radical-7 can communicate monitored parameters and measurements.*

Root Display and Touchscreen

Provides an interface for user interactions.

Home Button

Provides access to the Main Screen.

Root Charging Indicator

Shows an indication of the battery charge for Root.

Chapter 1: Description

Root can be used in the following ways:

 As a docking station and charger for Radical-7  As a bedside monitoring display for parameters on Radical-7 and

MOC-9 modules

 As a connectivity gateway for standalone devices.

Features

Front View

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Root Chapter 1: Description

Ref.

Feature

Description

AC Power Indicator

Shows an indication of AC power connection Root.

Radical-7 Charging Indicator

Shows an indication of battery charge for the Radical-7 in the Docking Station.

Feature

Description

Handle

Allows the user to transport Root.

Speaker

Provides audible notification.

Nurse Call Connector

Provides a connection to a Nurse Call system.

*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

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Root Chapter 1: Description

Feature

Description

Ethernet Port

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

USB Ports (2)

Provide USB 2.0 connectivity.

Power Entry Module

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

Equipotential Ground Connector

Provides electrical grounding for Root.

Iris Connectivity Ports (4)

Provide connection for standalone devices.

Right side

Left side

Feature

Description

Side Views

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Root Chapter 1: Description

Feature

Description

System Status Lights

Provides an indication of alarms and system messages. See System Status Lights on page 63.

Power Button

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

MOC-9 Ports (3)

Provide connectivity for MOC-9 modules.

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Chapter 2: Setting Up

Unpacking and Inspection

To unpack and inspect Root

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

2. 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.

If anything is missing or damaged, contact Masimo's Technical Service Department. See Return Procedure on page 91.

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 79.

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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 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 and MOC-9 modules.

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Root Chapter 2: Setting Up

Securely plug the AC power cord into power entry module.

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

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 63 and About the Status Bar on page 29.

(1)

(2)

The Root Charging Indicator remains orange while the battery is charging and will illuminate green when Root is fully charged. See Battery Root on page 47 and About the Status Bar on page 29.

For information about Standby Mode and Power Off, See Standby and Power Off on page 65.

Initial Battery Charging

To charge the battery for the first time

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

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Root Chapter 2: Setting Up

Radical-7 Connection

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

 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 on page 64.

Nurse Call Connection Port

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

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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 on page 51.

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Chapter 3: Operation

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

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Root Chapter 3: Operation

Ref.

Feature

Description

Status Bar

Displays system status as well as icons that provide shortcuts to menu items or actions. See About the Status Bar on page 29.

Windows

Provides a dynamic, user-configurable display area for all the data from Radical-7 or a MOC-9 module.

Main Menu icon

Provides access to the configuration options for Root, Radical-7 and MOC-9 modules. See Accessing Main Menu Options on page 43.

About the Main Screen

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

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+ 72 hidden pages