Masimo O3 Regional Oximeter Operator's Manual
Operator's Manual
O3® Regional Oximeter
For Sale in the USA.
These operating instructions intend to provide the necessary information for proper
operation of the O3
Module and O3
®
Regional Oximeter System (O3® System) which consists of the 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
®
Sensor(s) and Root®, including display details as well as accessing and changing
O3
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.: 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®, 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
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O3® Regional Oximeter Contents
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
general use of the O3
®
Module and O3® Sensor. Important safety information relating to
®
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 rSO
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.
measurements
2
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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. Refer to the Operator’s Manual for
Root for additional safety information, warnings and cautions.
Safety Warnings and Cautions
WARNING: Do not use the O3® Module if it appears or is suspected to be damaged.
WARNING: Only use O3
parts from other systems. Injury to personnel or equipment damage could occur.
WARNING: Do not adjust, repair, open, disassemble, or modify the O3
personnel or equipment damage could occur.
WARNING: Do not start or operate the O3
correct.
WARNING: Do not use O3
environment.
WARNING: Explosion hazard: Do not use the O3
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:
®
Module in conjunction with Root® and O3® Sensors. Do not use
®
Module. Injury to
®
Module unless the setup was verified to be
®
Module during magnetic resonance imaging (MRI) or in an MRI
®
Module and O3® Sensor in the presence of
• 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.
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
accuracy or availability of the parameters and measurements.
WARNING: The O3
require up to 15 seconds to return to normal operation.
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Module may be used during defibrillation, but this may affect the
®
Module may be used during defibrillation; however, the display may
O3® Regional Oximeter Safety Information, Warnings and Cautions
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: Optical measurements (rSO
) can be affected by the following:
2
• Improper sensor application or use of incorrect sensor.
• Intravascular dyes such as indocyanine green or methylene blue or externally
applied coloring (such as indelible ink).
• Venous congestion and pooled blood under the skin.
• Moisture, birthmarks, skin discoloration or foreign objects (e.g. metal plate)
in the light path.
• Elevated level of total bilirubin.
• A physiological condition that may effect vasomotor tone or changes in
vasomotor tone.
• Excessive ambient light, high intensity light, or direct sunlight.
• Adjacent placement of optical sensors that are not connected to the same
®
O3
Module.
• Abnormal venous pulsations (e.g. tricuspid value regurgitation,
Trendelenburg position).
WARNING: Inaccurate rSO2 readings or no rSO2 readings may be caused by:
• Anemia or low hemoglobin concentrations.
• Hemoglobinopathies (qualitative defects including sickle cell) and
Hemoglobin synthesis disorders (Quantitative defects such as
Thalassemias).
• Elevated COHb and/or MetHb levels.
• Non-normocapnic conditions or other conditions that affect blood volume.
• Hypotension, severe vasoconstriction, or hypothermia.
• Induction of extracranial hypoxia-ischemia.
• Cardiac arrest.
• Electrosurgical interference.
• Excessive induced motion.
WARNING: For patients experiencing complete bilateral External Carotid Artery (ECA)
occlusion, rSO
CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check
the limits each time the O3
measurements may be lower than expected.
2
®
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.
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O3® Regional Oximeter Safety Information, Warnings and Cautions
CAUTION: Reset Baseline for each new patient monitored, if applicable.
CAUTION: rSO2 readings represent a small volume of tissue beneath the O3® Sensor site and
may not reflect oxygenation elsewhere.
CAUTION: High ambient light sources such as surgical lights (especially those with a xenon
light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight
can interfere with the performance of the sensor.
CAUTION: Replace the sensor when a Replace Sensor message is consistently displayed
while monitoring consecutive patients after completing the Replace Sensor troubleshooting
steps listed in the troubleshooting section.
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 rSO2 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 rSO2 in the cerebral region under the
sensors. Other Body Sensor Sites selections are for reference only and are not intended for
patient monitoring.
Note: The O3® Sensor duration of use is dependent on the condition of the sensor site and
patient’s skin integrity and sensor adhesion quality. The O3
®
Sensor has been
biocompatibility tested for the intended continuous use up to 72 hours.
Note: Cables and sensors are provided with X-Cal
®
technology to minimize the risk of
inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or
Sensor DFU for the specified duration of patient monitoring time.
Cleaning and Service Warnings and Cautions
WARNING: Do not use petroleum-based or acetone solutions, or other harsh solvents, to
clean the O3
result.
WARNING: A functional tester cannot be used to assess the accuracy of the O3
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.
®
Module. These substances affect the device’s materials and device failure can
®
Module.
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.
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O3® Regional Oximeter Safety Information, Warnings and Cautions
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® Module System (O3® System) is as follows:
Overview
The O3® Regional Oximeter System (O3® System) operating principle is based on
multi-distance diffuse reflectance spectroscopy. The O3
cross-section tissue microvasculature (a mixed bed of arterioles, capillaries, and venules) and
analyzes the light returned after having passed through the tissues.
®
System uses light to examine a
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, I
traveled a distance of Δ in a medium with an absorption coefficient of µa.
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.
is light intensity at the source, and I is light intensity after having
o
Figure 1: Absorption coefficients of tissue chromophores in the NIR spectrum*
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O3® Regional Oximeter Chapter 1: Technology
Masimo’s O3® 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 rSO2.
* Beard P. Biomedical photoacoustic imaging. Interface Focus 2011;1:602-631.
Components of the Regional Oximetry System
The Masimo O3® Regional Oximetry System uses a common emitter and at least two (2)
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 traveled through relatively superficial (shallow) section of tissue.
• Deep detector: This detector is farther from the emitter and receives optical signal
traveled 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
oxygenation.
This geometry leads to the following relationships that allow the calculation of rSO2 in the
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 traveled. (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.
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