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O3
Operator's Manual
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Masimo O3 Operator's Manual

Operator's Manual
O3™ Regional Oximeter
For Sale in the USA.
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.: 949-297-7000 Fax.: 949-297-7001 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
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O3 Regional Oximeter Contents
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 (rSO any healthcare environment where rSO
2
), including cerebral tissue. It can be used in
2
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.
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Safety Information, Warnings and Cautions

CAUTION: The O3™ Regional Oximeter System is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use.

Safety Warnings and Cautions

WARNING: Do not use the O3 Module if it appears or is suspected to be damaged.
WARNING: Always use O3 Module in conjunction with Root and O3 Sensors. Do not use parts
from other systems. Injury to personnel or equipment damage could occur.
WARNING: Do not adjust, repair, open, disassemble, or modify the O3 Module. Injury to personnel or equipment damage could occur.
WARNING: Do not start or operate the O3 Module unless the setup was verified to be correct.
WARNING: Do not use O3 Module during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Explosion hazard: Do not use the O3 Module in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
WARNING: To protect against injury, follow the directions below:
• Avoid placing the device on surfaces with visible liquid spills.
• Do not soak or immerse the device in liquids.
• Use cleaning solutions only as instructed in this Operator's Manual.
• Do not attempt to clean O3 Module while monitoring patient.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
WARNING: Always verify the sensor description displayed correlates to the actual sensor application site on the patient.
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O3 Regional Oximeter Safety Information, Warnings and Cautions

Performance Warnings and Cautions

WARNING: The O3 Module may be used during electrocautery, but this may affect the accuracy or availability of the parameters and measurements.
WARNING: The O3 Module may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements.
WARNING: The O3 Module may be used during defibrillation; however, the display may require up to 15 seconds to return to normal operation.
WARNING: The O3 Module is intended only as an adjunct device in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with clinical signs and symptoms.
WARNING: If the desired tissues cannot be palpated or visualized, it is recommended to use a secondary method of confirmation, such as ultrasound or X-ray.
WARNING: Inaccurate rSO
• Anemia or low hemoglobin concentrations.
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb
c, sickle cell, etc.
• Hemoglobin synthesis disorders.
• Elevated levels of carboxyhemoglobin (COHb), methemoglobin (MetHb), or
other dyshemoglobins.
• Elevated level of total bilirubin.
• Non-normocapnic conditions or other conditions that affect blood volume.
• Hypotension, severe vasoconstriction, or hypothermia.
• Induction of extracranial hypoxia-ischemia.
• Cardiac arrest.
• Venous congestion and pooled blood under the skin.
• Intravascular dyes or externally applied coloring (such as indelible ink).
• Birthmark(s) or skin discolorations in sensor path.
• Moisture on the skin.
• Excessive motion.
• Metal plate or other foreign object in sensor path.
• Excessive ambient light or direct sunlight.
• Electrosurgical interference.
• Improperly applied sensor.
• Incorrect sensor type
• Adjacent placement of any sensor that is not connected to the same O3
Module.
WARNING: For patients experiencing complete bilateral ECA occlusion, rSO may be lower than expected.
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readings or no rSO2 readings may be caused by:
2
measurements
2
O3 Regional Oximeter Safety Information, Warnings and Cautions
WARNING: Inaccurate Delta SpO2 (ΔSpO2) readings may be caused by:
• Improper sensor application
• Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur
with a seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
• Intravascular dyes such as indocyanine green or methylene blue
• Externally applied coloring and texture such as nail polish, acrylic nails,
glitter, etc.
• Elevated levels of bilirubin.
• Severe anemia.
• Low arterial perfusion.
• Motion artifact.
• Venous pulsations.
CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time the O3 Module is used.
CAUTION: Do not place the O3 Module on electrical equipment that may affect the device, preventing it from working properly.
CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to the O3 Module.
CAUTION: Reset Baseline for each new patient monitored, if applicable.
CAUTION: rSO
may not reflect oxygenation elsewhere.
readings represent a small volume of tissue beneath the O3 Sensor site and
2
CAUTION: Check the sensor site periodically for circulatory status. Each patient’s sensitivity to the O3 sensors may vary depending on their medical status or condition of their skin.
Note: The value of data from the system has not been demonstrated in specific disease states, under conditions of hemoglobinopathies or clinical conditions that may affect blood volume, or under hypocapnic and hypercapnic conditions.
Note: The O3 system is intended for the monitoring of rSO sensors. Other Body Sensor Sites selections are for reference only and are not intended for
in the cerebral region under the
2
patient monitoring.
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O3 Regional Oximeter Safety Information, Warnings and Cautions

Cleaning and Service Warnings and Cautions

WARNING: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the O3 Module. These substances affect the device’s materials and device failure can result.
WARNING: A functional tester cannot be used to assess the accuracy of the O3 Module.
CAUTION: Do not submerge the O3 Module in any cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the O3 Module.
CAUTION: An operator may only perform maintenance procedures specifically described in the manual. Refer servicing to qualified service personnel trained in the repair of this equipment.

Compliance Warnings and Cautions

WARNING: Changes or modifications not expressly approved by Masimo shall void the warranty for this equipment.
CAUTION: Disposal of product - Comply with local laws in the disposal of the device and/or its accessories.
CAUTION: For FCC compliance information, refer to the Operator's Manual for Root.
Note: Use the O3 Module in accordance with the Environmental Specifications section in the
Operator's Manual.
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Chapter 1: Technology

The principle of operation for the O3 Regional Oximeter System (O3 System) is as follows:

Overview

The O3 System’s operating principle is based on multi-distance diffuse reflectance spectroscopy. The O3 System uses light to examine a cross-section tissue microvasculature (a mixed bed of arterioles, capillaries, and venules) and analyzes the light returned after having passed through the tissues.

Principles of Beer-Lambert Law and Regional Oximetry

The Beer-Lambert Law describes the attenuation of light through a medium as a function of the path length (or distance) and the absorption coefficient of the medium. The Beer-Lambert Law may be written as:
In the above equation, Io is light intensity at the source, and I is light intensity after having traveled a distance of Δ in a medium with an absorption coefficient of µa.
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O3 Regional Oximeter Chapter 1: Technology
The human body is opaque to most visible light frequencies, yet it is more transparent to red and infrared light. Moreover, light absorptions of oxygen-related chromophores, such as oxygenated and deoxygenated hemoglobin, vary as a function of wavelength in the near infrared spectrum, as shown in Figure 1. Therefore, if the level of oxygenation in the tissue changes, optical characteristics of the tissue also change according to the concentrations of oxygenated and deoxygenated hemoglobin. This absorption of light by the chromophore concentrations forms the basis of measurement of oxygen saturation, defined as the ratio of oxygenated hemoglobin to total hemoglobin.
Figure 1: Absorption coefficients of tissue chromophores in the NIR spectrum*
Masimo’s regional oximeter consists of a light emitter and multiple detectors. By emitting multiple wavelengths of light (LEDs), which pass through the region of interest, and measuring them (using photo-detectors) after they have traveled through the tissue, the system calculates attenuation experienced by each wavelength. These optical attenuations are then mapped to rSO
.
2
* Beard P. Biomedical photoacoustic imaging. Interface Focus 2011;1:602-631.
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O3 Regional Oximeter Chapter 1: Technology

Components of the Regional Oximetry System

The regional oximetery system uses a common emitter and at least two detectors that are spaced apart from each other and are at different distances relative to the emitter. In the case of a two-detector system, as in Figure 2, the detectors may be known as:
• Shallow detector: This detector is closer to the emitter (LEDs) and receives the optical signal travelled through relatively superficial (shallow) section of tissue.
• Deep detector: This detector is farther from the emitter and receives optical signal travelled deeper into the tissue, in addition to passing through superficial layers.
Figure 2: Schematic of an example of a regional oximeter sensor measuring deep tissue
This geometry leads to the following relationships that allow the calculation of rSO deep tissue.
1. Optical signals received at the same detector have traveled the same path. However, due to their different wavelengths, their attenuations are different, as light absorption depends on the wavelength. (In the Beer-Lambert Law, it leads to
different µa and same Δ.)
2. Optical signals of the same wavelength received at different detectors see the same tissue absorption coefficient, but experience different attenuation due to the
different paths they have travelled. (In the Beer-Lambert Law, it leads to same µa and different Δ.)
Deep tissue oxygenation can therefore be calculated by subtracting the effects of shallow tissue from deep tissue via manipulating signals received at the deep and shallow detectors.
oxygenation.
in the
2
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