Masimo Root Manuale utente
Operator's Manual
Root®
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.
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:VFK-RDS7A IC:7362A-RDS7A IC Model: RDS-7A
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
PVi, Radical-7, rainbow, Root, RRa, SedLine, SET, Signal Extraction Technology, SpCO, SpHb,
SpMet, Masimo and , are federally registered trademarks of Masimo Corporation.
Iris, ISA, MOC-9, MyView, Radius-7 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.
© 2017 Masimo Corporation
www.masimo.com 3 Masimo
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
Chapter 3: Operation-------------------------------------------------------------------------------------- 27
About the Main Screen-------------------------------------------------------------------------------- 27
About the Status Bar ----------------------------------------------------------------------------------28
About the Action Bar ---------------------------------------------------------------------------------- 31
Using the Touchscreen Interface--------------------------------------------------------------------32
Menu Navigation-------------------------------------------------------------------------------------- 35
Understanding Windows----------------------------------------------------------------------------- 36
Accessing Main Menu Options-----------------------------------------------------------------------43
Alarm Interface---------------------------------------------------------------------------------------- 60
Root Contents
www.masimo.com 4 Masimo
Trend Download----------------------------------------------------------------------------------------65
Session Management ---------------------------------------------------------------------------------65
Screenshot Capture------------------------------------------------------------------------------------65
Lights ---------------------------------------------------------------------------------------------------- 67
Chapter 4: Admit and Discharge to Patient SafetyNet---------------------------------------------- 71
Not Admitted ------------------------------------------------------------------------------------------- 71
Admitting a Patient ----------------------------------------------------------------------------------- 72
Discharging a Patient --------------------------------------------------------------------------------- 73
Not Monitoring Message ----------------------------------------------------------------------------- 74
Monitoring Resumed Message----------------------------------------------------------------------- 75
Electronic Medical Record (EMR) Push ------------------------------------------------------------ 75
Chapter 5: Radius-7 --------------------------------------------------------------------------------------- 79
Chapter 6: MOC-9 ----------------------------------------------------------------------------------------- 81
Using MOC-9 Ports ------------------------------------------------------------------------------------ 81
Chapter 7: Iris ----------------------------------------------------------------------------------------------83
Iris Status Screen --------------------------------------------------------------------------------------84
Using Iris Connectivity Ports ------------------------------------------------------------------------85
Chapter 8: Messages-------------------------------------------------------------------------------------- 87
Chapter 9: Troubleshooting -----------------------------------------------------------------------------89
Troubleshooting Radical-7, Radius-7, and MOC-9 Modules-------------------------------------89
Troubleshooting Root ---------------------------------------------------------------------------------89
Chapter 10: Specifications------------------------------------------------------------------------------- 91
Alarms --------------------------------------------------------------------------------------------------- 91
Nurse Call Specifications ----------------------------------------------------------------------------- 91
Connectors ---------------------------------------------------------------------------------------------- 91
Electrical-------------------------------------------------------------------------------------------------92
Environmental------------------------------------------------------------------------------------------92
Touchscreen Display-----------------------------------------------------------------------------------93
Wireless Specifications -------------------------------------------------------------------------------93
Compliance ---------------------------------------------------------------------------------------------95
Guidance and Manufacturer's Declaration-Electromagnetic Emissions----------------------96
Guidance and Manufacturer's Declaration-Electromagnetic Immunity ---------------------- 97
Recommended Separation Distances --------------------------------------------------------------99
Root Contents
www.masimo.com 5 Masimo
Symbols------------------------------------------------------------------------------------------------100
Chapter 11: Service and Maintenance---------------------------------------------------------------- 103
Cleaning ----------------------------------------------------------------------------------------------- 103
Replacing the Fuses --------------------------------------------------------------------------------- 103
Power-On Self Test----------------------------------------------------------------------------------- 104
Nurse Call Setting Connections ------------------------------------------------------------------- 104
Battery Test ------------------------------------------------------------------------------------------- 105
Repair Policy ------------------------------------------------------------------------------------------ 105
Return Procedure------------------------------------------------------------------------------------- 105
Contacting Masimo ---------------------------------------------------------------------------------- 106
Index ------------------------------------------------------------------------------------------------------- 109
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 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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