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
52 Discovery
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®, MOC-9®, O3®,rainbow®, Root®, and X-Cal®are federally
registered trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
© 2018 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---------------------------------------------------------------- 9
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 11
Compliance Warnings and Cautions---------------------------------------------------------------- 11
Chapter 1: Technology ------------------------------------------------------------------------------------13
Overview -------------------------------------------------------------------------------------------------13
Principles of Beer-Lambert Law and Regional Oximetry ----------------------------------------13
Components of the Regional Oximetry System--------------------------------------------------- 14
Chapter 2: System Description -------------------------------------------------------------------------- 15
Root------------------------------------------------------------------------------------------------------- 15
O3®Module and O3®Sensor------------------------------------------------------------------------- 16
Chapter 3: Setting Up the O3®System---------------------------------------------------------------- 17
Unpacking and Inspecting the System------------------------------------------------------------- 17
Preparation for Use ------------------------------------------------------------------------------------ 17
Connecting the O3®Module to Root®-------------------------------------------------------------- 17
Connecting the O3®Sensor(s) to the O3®Module ----------------------------------------------19
Chapter 4: Operation-------------------------------------------------------------------------------------- 21
Regional Oxygenation Information ----------------------------------------------------------------- 21
The O3®Module Window -----------------------------------------------------------------------------22
Display and Alarm Settings ------------------------------------------------------------------------- 30
Chapter 5: Errors and Alarms--------------------------------------------------------------------------- 33
Exception Messages ---------------------------------------------------------------------------------- 33
Alarms Messages---------------------------------------------------------------------------------------34
Chapter 6: Troubleshooting----------------------------------------------------------------------------- 35
Troubleshooting O3®Module ----------------------------------------------------------------------- 35
Chapter 7: Specifications --------------------------------------------------------------------------------- 37

O3® Regional Oximeter Contents
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Display Ranges and Resolution---------------------------------------------------------------------- 37
Accuracy (ARMS)--------------------------------------------------------------------------------------- 37
Environment--------------------------------------------------------------------------------------------38
Physical Characteristics of the Module ------------------------------------------------------------38
Symbols--------------------------------------------------------------------------------------------------39
Guidance and Manufacturer's Declarations ------------------------------------------------------- 41
Chapter 8: Service and Maintenance ------------------------------------------------------------------43
Cleaning Procedure------------------------------------------------------------------------------------43
General Maintenance for O3®Module -------------------------------------------------------------43
Service Instructions -----------------------------------------------------------------------------------43
Repair Policy-------------------------------------------------------------------------------------------- 44
Return Procedure -------------------------------------------------------------------------------------- 44
Contacting Masimo------------------------------------------------------------------------------------ 44
Sales & End-User License Agreement--------------------------------------------------------------45
Warranty------------------------------------------------------------------------------------------------- 45
Exclusions ----------------------------------------------------------------------------------------------- 45
End-User License -------------------------------------------------------------------------------------- 45
Restrictions --------------------------------------------------------------------------------------------- 46
No Implied License------------------------------------------------------------------------------------46
Index --------------------------------------------------------------------------------------------------------- 47

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About this Manual
This manual explains how to set up and use the O3®Regional Oximeter System (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®Regional Oximeter System (O3®System), which consists of the O3®Module and O3®
Sensor, is a patient-connected, noninvasive oximeter designed to continuously measure and
monitor regional hemoglobin oxygen saturation in the tissue (rSO2), including cerebral
tissue. It can be used in any hospital and hospital-type facility where rSO2measurements
might improve patient outcomes.
The O3®Regional Oximeter System (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 and on pediatrics ≥ 5 kg and <
40 kg in healthcare environments.
Contraindication
There are no contraindications.