Masimo O3 Regional Oximeter User manual

Operator's Manual
O3™ Regional Oximeter

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For Sale in the USA.
These operating instructions intend to provide the necessary information for proper
operation of the O3™ Regional Oximeter System (O3 System) which consists of the O3
Module and O3 Sensor. 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 the O3™ Regional Oximeter are prerequisites for proper use. Do not
operate the O3™ Regional Oximeter 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.
See instructions for use for full prescribing information, including indications,
contraindications, warnings, precautions, and adverse events.
This Operator's Manual describes how O3 Module information is displayed when used with O3
Sensor(s) and Root®, including display details as well as accessing and changing
user-configurable settings. For additional information related to Root, refer to the Operator's
Manual for Root. For additional information related to O3 Sensor, refer to the Directions for
Use for O3 Sensor
For further information contact:
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
Patents: www.masimo.com/patents.htm
®, FastSat®, FST®, Masimo®, Root®, Signal IQ® and rainbow®are federally registered
trademarks of Masimo Corporation.
O3 and MOC-9 are trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
© 2016 Masimo Corporation.

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Contents
About this Manual ------------------------------------------------------------------------------------------ 5
Product Description -----------------------------------------------------------------------------------------7
Indications for Use---------------------------------------------------------------------------------------7
Contraindication -----------------------------------------------------------------------------------------7
Safety Information, Warnings and Cautions ----------------------------------------------------------- 9
Safety Warnings and Cautions------------------------------------------------------------------------ 9
Performance Warnings and Cautions---------------------------------------------------------------10
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 12
Compliance Warnings and Cautions---------------------------------------------------------------- 12
Chapter 1: Technology ------------------------------------------------------------------------------------13
Overview -------------------------------------------------------------------------------------------------13
Principles of Beer-Lambert Law and Regional Oximetry ----------------------------------------13
Components of the Regional Oximetry System---------------------------------------------------15
Chapter 2: System Description -------------------------------------------------------------------------- 17
Root------------------------------------------------------------------------------------------------------- 17
O3 Module and O3 Sensor----------------------------------------------------------------------------18
Chapter 3: Setting Up the O3 System ----------------------------------------------------------------- 19
Unpacking and Inspecting the System-------------------------------------------------------------19
Preparation for Use ------------------------------------------------------------------------------------ 19
Connecting the O3 Module to Root -----------------------------------------------------------------19
Connecting the O3 Sensor(s) to the O3 Module-------------------------------------------------- 21
Chapter 4: Operation--------------------------------------------------------------------------------------23
Regional Oxygenation Information -----------------------------------------------------------------23
The O3 Module Window-------------------------------------------------------------------------------25
Display and Alarm Settings ------------------------------------------------------------------------- 33
Chapter 5: Errors and Alarms----------------------------------------------------------------------------37
Exception Messages ----------------------------------------------------------------------------------- 37
Alarms Messages-------------------------------------------------------------------------------------- 38
Chapter 6: Troubleshooting----------------------------------------------------------------------------- 39
Troubleshooting O3 Module------------------------------------------------------------------------- 39
Chapter 7: Specifications --------------------------------------------------------------------------------- 41

O3 Regional Oximeter Contents
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Display Ranges and Resolution---------------------------------------------------------------------- 41
Measurement Accuracy ------------------------------------------------------------------------------- 41
Environment-------------------------------------------------------------------------------------------- 42
Physical Characteristics of the Module ------------------------------------------------------------ 42
Symbols--------------------------------------------------------------------------------------------------43
Guidance and Manufacturer's Declarations -------------------------------------------------------45
Citations------------------------------------------------------------------------------------------------- 46
Chapter 8: Service and Maintenance ------------------------------------------------------------------ 47
Cleaning Procedure------------------------------------------------------------------------------------ 47
General Maintenance for O3 Module--------------------------------------------------------------- 47
Service Instructions ----------------------------------------------------------------------------------- 47
Repair Policy--------------------------------------------------------------------------------------------48
Return Procedure --------------------------------------------------------------------------------------48
Contacting Masimo------------------------------------------------------------------------------------49
Sales & End-User License Agreement-------------------------------------------------------------- 49
Warranty-------------------------------------------------------------------------------------------------49
Exclusions ----------------------------------------------------------------------------------------------- 49
End-User License --------------------------------------------------------------------------------------50
Restrictions ---------------------------------------------------------------------------------------------50
No Implied License------------------------------------------------------------------------------------ 51
Index ---------------------------------------------------------------------------------------------------------53

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About this Manual
This manual explains how to set up and use the O3 System, which consists of the O3 Module
and O3 Sensor. Important safety information relating to general use of the O3 System
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 and 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 and user to avoid
injury to the patient and user, damage to this instrument or damage to other property. The
following is an example of a caution:
CAUTION: This is an example of a 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
The O3 System is a patient-connected, noninvasive oximeter designed to monitor regional
hemoglobin oxygen saturation in the tissue (rSO2), including cerebral tissue. It can be used in
any healthcare environment where rSO2 measurements might improve patient outcomes.
The O3 System should not be used as the sole basis for diagnosis or therapy.
Indications for Use
The noninvasive Masimo O3™ Regional Oximeter System and accessories are intended for use
as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of
blood (rSO2) in the cerebral region under the sensors. The Masimo O3™ Regional Oximeter
System and accessories are indicated for use on adults >= 40 kg in healthcare environments.
Contraindication
The O3™ Regional Oximeter System is not indicated for use on patients <40 kg.