O3 Regional Oximeter Operators Manual June 2017

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 ---------------------------------------------------- 11 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 ----------------------------------------------------------------------------- 24 Display and Alarm Settings -------------------------------------------------------------------------- 32 Chapter 5: Errors and Alarms --------------------------------------------------------------------------- 35 Exception Messages ---------------------------------------------------------------------------------- 35 Alarms Messages -------------------------------------------------------------------------------------- 36 Chapter 6: Troubleshooting ------------------------------------------------------------------------------ 37 ®

Troubleshooting O3 Module ------------------------------------------------------------------------ 37 Chapter 7: Specifications -------------------------------------------------------------------------------- 39 www.masimo.com

3

Masimo

O3® Regional Oximeter

Contents

Display Ranges and Resolution---------------------------------------------------------------------- 39 Accuracy (ARMS) --------------------------------------------------------------------------------------- 39 Environment -------------------------------------------------------------------------------------------- 40 Physical Characteristics of the Module ------------------------------------------------------------ 40 Symbols-------------------------------------------------------------------------------------------------- 41 Guidance and Manufacturer's Declarations ------------------------------------------------------- 44 Chapter 8: Service and Maintenance ------------------------------------------------------------------ 45 Cleaning Procedure ------------------------------------------------------------------------------------ 45 ®

General Maintenance for O3 Module ------------------------------------------------------------- 45 Service Instructions ----------------------------------------------------------------------------------- 45 Repair Policy -------------------------------------------------------------------------------------------- 46 Return Procedure -------------------------------------------------------------------------------------- 46 Contacting Masimo ------------------------------------------------------------------------------------ 47 Sales & End-User License Agreement -------------------------------------------------------------- 47 Warranty ------------------------------------------------------------------------------------------------- 47 Exclusions ----------------------------------------------------------------------------------------------- 47 End-User License -------------------------------------------------------------------------------------- 48 Restrictions --------------------------------------------------------------------------------------------- 48 No Implied License ------------------------------------------------------------------------------------ 49 Index --------------------------------------------------------------------------------------------------------- 51

www.masimo.com

4

Masimo

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.

www.masimo.com

5

Masimo

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 rSO2 measurements 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.

www.masimo.com

7

Masimo

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® 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 and O3® Sensor 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.

www.masimo.com

9

Masimo

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: Optical measurements (rSO2) can be affected by the following: •

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.

www.masimo.com

10

Masimo

O3® Regional Oximeter

Safety Information, Warnings and Cautions

WARNING: For patients experiencing complete bilateral External Carotid Artery (ECA) occlusion, rSO2 measurements may be lower than expected. 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: 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: 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. CAUTION: Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed while monitoring consecutive patients after completing the low SIQ troubleshooting steps listed in the troubleshooting section. 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® 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. www.masimo.com

11

Masimo

O3® Regional Oximeter

Safety Information, Warnings and Cautions

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.

www.masimo.com

12

Masimo

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® 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.

www.masimo.com

13

Masimo

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 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.

www.masimo.com

14

Masimo

O3® Regional Oximeter

Chapter 1: Technology

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.

2.

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.) 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.

www.masimo.com

15

Masimo

Chapter 2: System Description The O3® Regional Oximeter System (O3® System) is comprised of three (3) components: •

Root®

•

O3® Module

•

O3® Sensor(s)

Up to two (2) O3® Sensors can be connected to a single O3® Module. Up to two (2) O3® Modules can be connected to Root®.

Root

Root® displays parameters and trends that relate to regional oxygen saturation (rSO2). For more information about Root®, see Operator’s Manual for Root®.

www.masimo.com

17

Masimo

O3® Regional Oximeter

Chapter 2: System Description

O3® Module and O3® Sensor

The O3® System consists of the O3® Module and O3® Sensors. The O3® Sensors comprise of LED components that collect physiological signals. The O3® Module includes Masimo technology for processing the signals which result in rSO2 measurements. In turn, these measurements are displayed on the Host/Backboard device. The O3® Sensors are a single-patient use adhesive sensor, which comprises of a single emitter and two detectors. For more information about the O3® Sensor series, see Directions for Use for the O3® Sensor series. The cable connection for the O3® Sensor consists of two (2) configurations. The difference between the two (2) configurations is that one version is a detached cable connection, where the O3® Sensor connects into the O3® Module directly. In the other version, the connection is integrated within the O3® Module on one end and the other end has a connection for the O3® Sensor(s).

www.masimo.com

18

Masimo

Chapter 3: Setting Up the O3® System For initial use of the O3® System, the following setup instructions must be followed.

Unpacking and Inspecting the System 1. 2. 3.

Remove the components from the shipping carton and examine them for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact the Masimo Technical Service Department.

Preparation for Use Prior to using the O3® System for monitoring 1.

2.

Confirm that you have all system components: •

Root®

•

O3® Module

• O3® Sensor(s) Confirm that Root® holds adequate battery power.

Connecting the O3® Module to Root® Up to two (2) O3® Modules can be connected to Root®. To connect a Module to Root®: 1.

Identify the Masimo Open Connect (MOC-9™) connector on the O3® Module, as illustrated in the image below.

www.masimo.com

19

Masimo

O3® Regional Oximeter

Chapter 3: Setting Up the O3® System

2.

Insert the MOC-9™ connector securely into a MOC-9™ Port on Root®, as illustrated in the image below.

3.

The module is now activated. This is verified when the O3® Module window displays on Root® with all parameters and measurements dashed out because no O3® Sensor has been connected to the module.

®

For more information on the O3® Module window, see The O3 Module Window on page 24. Repeat the steps above for the second module if more than two (2) O3® Sensors are intended to be used.

www.masimo.com

20

Masimo

O3® Regional Oximeter

Chapter 3: Setting Up the O3® System

Connecting the O3® Sensor(s) to the O3® Module Up to two (2) O3® Sensors can be connected to each O3® Module. The two (2) connections are symmetrical in orientation and clearly marked “1” and “2” on the module. ®

To connect an O3® Sensor to an activated O3 Module: 1. 2.

3.

Apply sensor on the patient. For more instructions on applying the sensor on the patient, see the Directions for Use for the O3® Sensor series. Once the sensor(s) has been properly applied on the patient, identify the connector end on the sensor, illustrated in the image below.

Align the connector with the appropriate sensor connection on the module, as illustrated in the image below. Note the markings of "1" and "2" above the connections.

1 - Left Forehead 2 - Right Forehead

www.masimo.com

21

Masimo

O3® Regional Oximeter 4.

5.

Chapter 3: Setting Up the O3® System

Insert the connector securely into the sensor connection. Note that "1" is defaulted to the left forehead and "2" is defaulted to the right forehead. The sensor site selection can be modified by accessing the Site Selection menu. For information ® on how to access the Site Selection menu, see The O3 Module Window on page 24. Press the Home button on the touchscreen to return to the main display.

www.masimo.com

22

Masimo

Chapter 4: Operation The following sections describe how O3® Module information is displayed when used with Root®, including display details and user-configurable settings. For additional information on Root®, see Operator’s Manual for Root®.

Regional Oxygenation Information Regional Oxygenation (rSO2) rSO2, measured in percentage (0 to 99%), is the regional tissue oxygenation level in the deep tissue local to the sensor site.

AUC Index (Area under the Curve) AUC, measured in % * minutes, is displayed as an index which quantifies the duration and depth of patient’s stay below the user-defined rSO2 low alarm limit (LAL). Duration (minutes) refers to the amount of time the patient stays below the rSO2 LAL. Depth (%) refers to the gap between the patient’s rSO2 level and the rSO2 LAL. AUC increases only when rSO2 level drops below the selected LAL.

Baseline This feature is displayed when Set Baseline has been enabled. To enable this option see Baseline View on page 28. Baseline rSO2 displays the user-defined baseline value for rSO2. Baseline is also shown as a triangular pointer on the y-axis of the trend display for rSO2. Note: When the sensor is on the patient, the baseline rSO2 value defaults to the current rSO2 value. When the sensor is not on the patient, the Baseline rSO2 value defaults to a minimum value of 10%.

Delta Baseline (Δbase) This feature is displayed when Set Baseline has been enabled. To enable this option see Baseline View on page 28. Δbase, measured in percentage, is the relative decrease in rSO2 with respect to baseline rSO2.

Delta SpO2 (ΔSpO2) About An informational read-only screen appears with the following definition for ΔSpO2 Settings: Delta SpO2 (ΔSpO2), displayed as a percentage, is the calculated difference between rSO2 and SpO2. Source of SpO2 is the peripheral SpO2 (using a pulse oximeter, if available), depending on user selection. www.masimo.com

23

Masimo

O3® Regional Oximeter

Chapter 4: Operation

The O3® Module Window When an O3® Module is connected to Root, O3® Module parameters and measurements display in the O3® Module window as numeric values with graphical representations. Each O3® Sensor connected will generate a separate O3® Module window, with the Sensor Label displayed in the name of the window. When multiple technologies are connected to Root®, each technology’s parameters are displayed in an individual window. The relative size of each window can be configured using the Layout feature, which is accessible by pressing the "Layout" icon in the Main Menu. For more information, see Operator's Manual for Root®. In the image below, Masimo Radical-7 Pulse CO-Oximeter parameters and measurements are displayed in the rainbow window; and O3® Module parameters and measurements are displayed in a separate O3® Module window.

www.masimo.com

24

Masimo