Masimo Root User manual

Operator's Manual
Root®
with noninvasive blood pressure
and temperature

www.masimo.com 1 Masimo
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.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
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.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
Wireless Radio
FCC ID:VFK-RDS7A
IC:7362A-RDS7A IC Model: RDS-7A
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
ETL Intertek certification.
Conforms to ANSI/AAMI ES 60601-1 and certified to CAN/CSA STD C22.2 No.
60601-1, IEC 60601-2-49, ISO 80601-2-56, and IEC 80601-2-30
Patents: www.masimo.com/patents.htm
© 2016 Masimo Corporation
Root, SedLine, Radical-7, rainbow, SET, Signal Extraction Technology, Masimo and , are
federally registered trademarks of Masimo Corporation.
MOC-9, Iris, Radius-7, 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.

www.masimo.com 3 Masimo
Contents
About this Manual -------------------------------------------------------------------------------------------7
Product Description, Features, and Indications for Use ---------------------------------------------- 9
Product Description and Features-------------------------------------------------------------------- 9
Indications for Use-------------------------------------------------------------------------------------- 9
Contraindication ---------------------------------------------------------------------------------------10
Safety Information, Warnings, and Cautions---------------------------------------------------------- 11
Safety Warnings and Cautions----------------------------------------------------------------------- 12
Performance Warnings and Cautions--------------------------------------------------------------- 14
Cleaning and Service Warnings and Cautions ----------------------------------------------------16
Compliance Warnings and Cautions----------------------------------------------------------------16
Chapter 1: Description ------------------------------------------------------------------------------------19
Features------------------------------------------------------------------------------------------------- 20
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
Radius-7 Connection----------------------------------------------------------------------------------- 27
Nurse Call Connection -------------------------------------------------------------------------------- 27
Attach the Probe Well---------------------------------------------------------------------------------28
Attach the Temperature Probe ----------------------------------------------------------------------28
Attach NIBP Cuff ---------------------------------------------------------------------------------------28
Chapter 3: Operation--------------------------------------------------------------------------------------29
About the Status Bar ----------------------------------------------------------------------------------29
About the Main Screen--------------------------------------------------------------------------------31
Using the Touchscreen Interface--------------------------------------------------------------------32
Menu Navigation-------------------------------------------------------------------------------------- 35
Understanding Windows----------------------------------------------------------------------------- 36
Accessing Main Menu Options-----------------------------------------------------------------------42
Alarm Interface---------------------------------------------------------------------------------------- 68

Root Contents
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Trend Download---------------------------------------------------------------------------------------- 73
Screenshot Capture------------------------------------------------------------------------------------ 73
Lights ---------------------------------------------------------------------------------------------------- 75
Chapter 4: Temperature Measurement ---------------------------------------------------------------- 79
Operation - Temperature ----------------------------------------------------------------------------- 79
Temperature Probes-----------------------------------------------------------------------------------82
Chapter 5: NIBP Measurement--------------------------------------------------------------------------85
Patient Measurement Mode -------------------------------------------------------------------------85
Cuff Selection and Placement -----------------------------------------------------------------------85
Patient Conditions------------------------------------------------------------------------------------- 87
Operation - NIBP---------------------------------------------------------------------------------------88
Chapter 6: Admit and Discharge to Patient SafetyNet ---------------------------------------------95
Not Admitted -------------------------------------------------------------------------------------------96
Discharging a Patient --------------------------------------------------------------------------------- 97
Admitting a Patient -----------------------------------------------------------------------------------98
Not Monitoring Message --------------------------------------------------------------------------- 100
Monitoring Resumed Message -------------------------------------------------------------------- 101
Chapter 7: Radius-7-------------------------------------------------------------------------------------- 103
Chapter 8: MOC-9 --------------------------------------------------------------------------------------- 105
Using MOC-9 Ports ---------------------------------------------------------------------------------- 105
Chapter 9: Iris-------------------------------------------------------------------------------------------- 107
Iris Status Screen ------------------------------------------------------------------------------------ 108
Using Iris Connectivity Ports ---------------------------------------------------------------------- 109
Chapter 10: Messages ----------------------------------------------------------------------------------- 111
Chapter 11: Troubleshooting ---------------------------------------------------------------------------115
Troubleshooting Radical-7, Radius-7, and MOC-9 Modules------------------------------------115
Troubleshooting Root --------------------------------------------------------------------------------115
Chapter 12: Specifications ------------------------------------------------------------------------------ 117
Measurement Accuracy ------------------------------------------------------------------------------ 117
Display Ranges ----------------------------------------------------------------------------------------118
NIBP Pressurization Ranges ------------------------------------------------------------------------119
Electrical -----------------------------------------------------------------------------------------------119
Environmental---------------------------------------------------------------------------------------- 120

Root Contents
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Touchscreen Display--------------------------------------------------------------------------------- 120
Alarms---------------------------------------------------------------------------------------------------121
Nurse Call Specifications ----------------------------------------------------------------------------121
Connectors -------------------------------------------------------------------------------------------- 122
Wireless Specifications ----------------------------------------------------------------------------- 122
Compliance-------------------------------------------------------------------------------------------- 124
Guidance and Manufacturer's Declaration-Electromagnetic Emissions---------------------127
Guidance and Manufacturer's Declaration-Electromagnetic Immunity -------------------- 128
Recommended Separation Distances ------------------------------------------------------------ 131
Symbols------------------------------------------------------------------------------------------------ 132
Chapter 13: Service and Maintenance --------------------------------------------------------------- 135
Cleaning ----------------------------------------------------------------------------------------------- 135
Replacing the Fuses --------------------------------------------------------------------------------- 135
Power-On Self Test----------------------------------------------------------------------------------- 136
NIBP Module Calibration --------------------------------------------------------------------------- 136
NIBP Air Leak Test ----------------------------------------------------------------------------------- 137
Zero Point Calibration------------------------------------------------------------------------------- 137
Span Point Calibration------------------------------------------------------------------------------ 137
Overpressure Test ------------------------------------------------------------------------------------ 138
Nurse Call Setting Connections ------------------------------------------------------------------- 139
Battery Test ------------------------------------------------------------------------------------------- 139
Repair Policy ------------------------------------------------------------------------------------------ 140
Return Procedure------------------------------------------------------------------------------------- 140
Contacting Masimo ---------------------------------------------------------------------------------- 140
Limited Warranty -------------------------------------------------------------------------------------141
Exclusions ----------------------------------------------------------------------------------------------141
Limitation of Warranty------------------------------------------------------------------------------ 142
Sales & End-User License Agreement ------------------------------------------------------------ 142
Restrictions ------------------------------------------------------------------------------------------- 143
Index ------------------------------------------------------------------------------------------------------- 145

www.masimo.com 7 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 a sample 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 a sample of a caution statement.
A note is given when additional general information is applicable.
Note: This is a sample of a note.