Root®

Operator's Manual

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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

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:

EC REP

MDSS GmbH

Schiffraben 41

D-30175 Hannover, Germany

CLASSIFIED UL US

Medical electrical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1

Patents: www.masimo.com/patents.htm

© 2014 Masimo Corporation

Root, SEDLine, Radical-7, rainbow, SET, Signal Extraction Technology, Masimo and V, are federally registered trademarks of Masimo Corporation.

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

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

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

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
www.masimo.com 3

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
www.masimo.com 4

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

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.

Product Description, Features and Intended Use

Product Description and Features

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

• Instantly interpretable, high-visibility display of Masimo's breakthrough SET® and rainbow® SET measurements from Masimo's Radical-7® Pulse CO-Oximeter (Radical-7) and the Radius-7™ Wearable Pulse CO-Oximeter (Radius-7).

Intuitive, touchscreen navigation for easy and