Masimo O3 Operator's Manual

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.: 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.

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

Contents www.masimo.com 4 Masimo 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 all-guide s.com

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.

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.

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. all-guide s.com

Safety Information, Warnings and Cautions www.masimo.com 10 Masimo 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 rSO2 readings or no rSO2 readings may be caused by: • 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, rSO2 measurements may be lower than expected.

Safety Information, Warnings and Cautions www.masimo.com 11 Masimo 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: rSO2 readings represent a small volume of tissue beneath the O3 Sensor site and may not reflect oxygenation elsewhere. 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 rSO2 in the cerebral region under the sensors. Other Body Sensor Sites selections are for reference only and are not intended for patient monitoring.

Safety Information, Warnings and Cautions www.masimo.com 12 Masimo 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.

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.

Chapter 1: Technology www.masimo.com 14 Masimo 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 rSO2. * Beard P. Biomedical photoacoustic imaging. Interface Focus 2011;1:602-631. all-guide s.com

Chapter 1: Technology www.masimo.com 15 Masimo 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 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 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.

The O3™ Regional Oximeter System (O3 System) is comprised of three (3) components: • Root • O3 Module • O3 Sensor(s) Up to two O3 Sensors can be connected to a single O3 Module. Up to two 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.

Chapter 2: System Description www.masimo.com 18 Masimo 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 Sensor is a single-patient use adhesive sensor, which comprises of a single emitter and two detectors. For more information about the O3 Sensor, see Directions for Use for the O3 Sensor. The O3 cable connection for the sensor consists of two configurations. The difference between the two 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).

For initial use of O3 System, the following setup instructions must be followed. Unpacking and Inspecting the System 1. Remove the components from the shipping carton and examine them for signs of shipping damage. 2. 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. 3. If anything is missing or damaged, contact the Masimo Technical Service Department. Preparation for Use Prior to using the O3 System for monitoring 1. Confirm that you have all system components: • Root • O3 Module • O3 Sensor(s) 2. Confirm that Root holds adequate battery power. Connecting the O3 Module to Root Up to two O3 Modules can be connected to Root. To connect a Module to Root: 1. Identify the Masimo Open Connect (MOC-9TM) connector on the O3 module, as illustrated in the image below. all-guide s.com

Chapter 3: Setting Up the O3 System www.masimo.com 20 Masimo 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 25. Repeat the steps above for the second module if more than two sensors are intended to be used.

Chapter 3: Setting Up the O3 System www.masimo.com 21 Masimo Connecting the O3 Sensor(s) to the O3 Module Up to two (2) 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. Apply sensor on the patient. For more instructions on applying the sensor on the patient, see the Directions for Use for the O3 Sensor. 2. Once the sensor(s) has been properly applied on the patient, identify the connector end on the sensor, illustrated in the image below. 3. 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

Chapter 3: Setting Up the O3 System www.masimo.com 22 Masimo 4. 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. See The O3 Module Window on page 25 for information on how to access the Site Selection menu. 5. Press the Home button on the touchscreen to return to the main display.

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 29 of the Operator's Manual. 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 29. Δbase, measured in percentage, is the relative decrease in rSO2 with respect to baseline rSO2.

Chapter 4: Operation www.masimo.com 24 Masimo Delta SpO2 (ΔSpO2) ΔSpO2, displayed as a percentage, is the calculated difference between rSO2 and SpO2. Source of SpO2 is from peripheral SpO2 (using pulse oximeter, if available), depending on user selection. Peripheral SpO2 measurements are not provided by the O3 Module. The measurements are provided by another device such as the Masimo pulse oximetry technology. all-guide s.com

Chapter 4: Operation www.masimo.com 25 Masimo 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, Radical-7 parameters and measurements are displayed in the rainbow window; and O3 Module parameters and measurements are displayed in a separate O3 Module window.

Chapter 4: Operation www.masimo.com 26 Masimo At the top-right corner of each O3 Module window, there is a drop-down menu which allows you to display options and access the site selection and set baseline menus for each O3 Sensor. Display Options There are two display options available: 1. Trend View 2. Baseline View Trend View Trend View is the default viewing option for an O3 window. The trend view displays rSO2 trends. This view offers two sensor displays for the two O3 Sensors that can connect to the module, as illustrated in the image below. Note that each sensor display is distinguished by the Sensor Label on the top left corner of each window. To enable/disable Trend View, tap the drop-down menu on the top right corner of the O3 Module window. Press the Trend button to enable or disable Trend View.

Chapter 4: Operation www.masimo.com 27 Masimo Each sensor display shows a multitude of information about O3 Module parameters and measurements and also allows the user to customize how the information is displayed. The various portions of a sensor display are outlined in the illustration and each portion is explained in more detail in the table below. Ref. Feature Description 1 Sensor Label Label identifies the sensor site that corresponds to the application site of the O3 Sensor. 2 SpO2 Trend Line Displays SpO2 level from the peripheral SpO2 sensor site over time1. 3 ΔSpO2 Region Displays the difference between levels of SpO2 (peripheral SpO2 sensor site) and rSO2 of the O3 Sensor site over time. 4 rSO2 Trend Line Displays rSO2 level of the O3 Sensor site over time. 5 Drop-down Menu Allows user to change display options and access the site selection and set baseline menus for each O3 Sensor. 6 rSO2 Value Indicates the current rSO2 level of the O3 Sensor site. Press the value to access the rSO2 menu. 7 %rSO2 Indicates the unit of measurement for rSO2 . 8 Time Frame Displays the current time frame of trending shown.

Chapter 4: Operation www.masimo.com 28 Masimo Ref. Feature Description Configurator Press “-” to shorten and “+” to lengthen the time frame of the trending displayed. 9 rSO2 Alarm Limits Indicates the selected high and low limit values which triggers an rSO2 alarm. Press the value to access the rSO2 menu. 10 ΔSpO2% Displays the difference between levels of SpO2 (peripheral SpO2 sensor site) and rSO2 of the O3 Sensor site. 11 AUC Displays the Area Under the Curve cumulative index. 12 Timeline Displays timestamps and corresponding date. 13 Δbase% Displays the current difference between levels of rSO2 and selected baseline rSO2. Also displays the unit of measurement (%). Press the value to access the Delta Baseline menu. 14 Y-axis Shows the current view range for rSO2. Press the axis to customize the viewing range for rSO2. 15 Baseline Indicator Indicates the baseline rSO2 value selected by the user. 1 From the pulse oximetry sensor connected to the Radical-7® in the Root device.

Chapter 4: Operation www.masimo.com 29 Masimo Baseline View In the Baseline view, the baseline rSO2 is seen as a horizontal yellow line across the entire trend display. To enable/disable Baseline View, tap the drop-down menu on the top right corner of the O3 Module window. Press the Baseline View button to enable or disable Baseline View. Ref. Feature Description 1 Baseline Indicator Indicates the baseline rSO2 value selected by the user. 2 Baseline Displays Baseline across the Trend area. The Baseline View is displayed only when Set Baseline has been enabled. The Baseline can be enabled in two ways: 1. Tap the drop-down menu on the top right corner of the O3 Module window. Press the Set Baseline button to enable the baseline for the sensors. Or 2. Press the Gear icon on the lower right corner of the main window of Root to access the Main Menu, then press the O3 icon to access the O3 Module Menu and select the Set Baseline menu. In the Set Baseline menu, select Enable. Press Ok to confirm and press the Home button to return to the Main Window. CAUTION: Reset Baseline for each new patient monitored, if applicable. Note: Configuration for this option does not hold through power cycle. all-guide s.com

Chapter 4: Operation www.masimo.com 30 Masimo Site Selection Menu 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. When the connector end on the O3 Sensor is first inserted into the O3 Module, 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. There are two ways to access this menu: 1. To access this menu tap the drop-down menu on the top right corner of the O3 Module window. Then press on the Site Selection button. Or 2. Press the Gear icon on the lower right corner of the main window of Root to access the Main Menu, then press the O3 icon to access the O3 Module Menu and select the Site Selection Menu. When the Site Selection menu is accessed, the sensor site screen displays on Root, as illustrated below: Select the Head or Body buttons at the upper left corner of the screen to switch between Head and Body Patient View site selection menus. Note: Sensor icons appear white when not selected and blue (with the corresponding sensor number) when selected.

Chapter 4: Operation www.masimo.com 31 Masimo Head Patient View Head is the default view when Site Selection is displayed. Ref Description 1 Choose either sensor 1 then sensor 2 to change sensor site location. Only the selected sensor location can be changed. Note that 1 is defaulted to Forehead Left and 2 is defaulted to Forehead Right. 2 Touch the new desired sensor site location in the image. The sensor site can be on the left, or right side of the body. 3 The new sensor site location will be displayed. Select OK to confirm the change. Repeat this process for the corresponding sensor as necessary. Press the Home button to return to the Main Screen.

Chapter 4: Operation www.masimo.com 32 Masimo Body Sensor Sites Select Body in the upper left corner of the screen to switch to the Body Sensor Sites locations display. Ref Description 1 Current location of sensor 1 and sensor 2 (Head). 2 Choose either the Sensor 1 or Sensor 2 button to select the sensor and change sensor site location. Only the selected sensor can be changed. 3 Touch the new desired sensor site location in the image. The sensor site can be on the left, or right side of the body. 4 The new sensor site location will be displayed. Select OK to confirm the change. Repeat this process for the corresponding sensor as necessary. Press the Home button to return to the Main Screen.

Chapter 4: Operation www.masimo.com 33 Masimo Display and Alarm Settings There are two ways to configure all parameter display and alarm settings: 1. Press the parameter icon in the O3 Module window of the specific sensor. This will take you directly to the settings options for the parameter. Select the appropriate setting and press Ok to confirm. Press the Home button to return to the main screen. Or 2. Press the Gear icon on the lower right corner of the main window to access the Main Menu. Then press the O3 icon to access the O3 menu. In the O3 menu select the POD icon to access the sensor menu. Press the appropriate O3 Sensor for which to configure specific parameter display and alarm settings. Below are the various setting options for each parameter. Note: All setting options will hold through power cycle, unless otherwise stated. rSO2 Settings The following are the various setting options for rSO2: About An informational read-only screen appears with the following definition for rSO2: rSO2, displayed as a percentage (0 to 99%), is the measure of regional tissue oxygenation (at the deep tissue level) local to the sensor site. Alarms Option Description Factory Default Configuration Options Resolution High Limit Upper threshold of rSO2 level that triggers an alarm. Off 2% to 99% Off 1% Low Limit Lower threshold of rSO2 level that triggers an alarm. 40% 1% to 98% 1% Silence Duration Duration of the temporary suspension of audible alarm for rSO2 when the Alarm Silence icon is pressed on Root. 2m 30s, 1m, 2m, 5m N/A

Chapter 4: Operation www.masimo.com 34 Masimo Trend Option Description Factory Default Configuration Options Y-Axis Max Maximum rSO2 level displayed in Trends area. 100% 5% to 100% Y-Axis Min Minimum rSO2 level displayed in Trends area. 50% 0 to 95% Additional Settings Option Description Factory Default Configuration Options Averaging Time Length of time over which the system calculates the average of all data points. 8s 8s, 16s, 24s AUC Settings The following are the various setting options for AUC: About An informational read-only screen appears with the following definition for AUC Settings: Area Under the Curve (AUC) (% * minutes), displayed as an index, 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. Additional Settings Option Description Factory Default Configuration Options Reset AUC Resets the AUC Index N/A Press Reset AUC to reset the value all-guide s.com

Chapter 4: Operation www.masimo.com 35 Masimo Delta Baseline (Δbase) Settings The following are the various setting options for Delta Baseline: About An informational read-only screen appears with the following definition for Delta Baseline Settings: Relative deficit below baseline displayed as a percentage of the baseline rSO2 level, is the difference between the user defined baseline rSO2 level and current rSO2 level. If rSO2 level is above the baseline, delta baseline will display as 0. Alarms Option Description Factory Default Configuration Options Resolution Delta Limit Threshold of Δbase that triggers an alarm. Off Off -1% to -99% -1% Silence Duration Duration of the temporary suspension of audible alarm for Δbase when the Alarm Silence icon is pressed on Root. 2m 30s, 1m, 2m N/A

Chapter 4: Operation www.masimo.com 36 Masimo Delta SpO2 (ΔSpO2) Settings Below is the setting option for Delta SpO2: 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 from peripheral SpO2 (using pulse oximeter, if available). Peripheral SpO2 measurements are not provided by the O3 Module. The measurements are provided by another device such as the Masimo pulse oximetry technology. Alarms Option Description Configuration Options Delta Source The peripheral SpO2 is compared against rSO2 to generate the ΔSpO2 measurement. Peripheral

Exception Messages The table below lists the types of messages that can appear on Root when using O3 Module and O3 Sensor. Exception Message Indication Regional Oximeter Disconnected The O3 Module is not connected to Root or has been disconnected from Root. No Cable Connected The O3 Module is not connected or not fully inserted into the MOC-9 Port. Incompatible Cable The O3 Module connected to Root cannot be used with Root. Defective Cable The O3 Module connected to Root is defective. No Sensor Connected The O3 Sensor is not connected or not fully inserted into the O3 Module, or the sensor is not applied on the patient. Incompatible Sensor The O3 Sensor connected to the O3 Module cannot be used with the O3 Module. Defective Sensor The O3 Sensor connected to the O3 Module is defective. Sensor Initializing The O3 Module is checking the connected O3 Sensor for proper functioning and performance. Sensor Off Patient The O3 Sensor is not applied on the patient, the sensor is not properly applied on the patient, or the Sensor is damaged. Pulse Search The O3 Module is searching for pulse. Interference Detected Signal interference to the O3 Module has been detected. Low Perfusion Index The signal detected is too weak. Check Sensor Connection The O3 Sensor may not be properly connected to the O3 Module.

Chapter 5: Errors and Alarms www.masimo.com 38 Masimo Alarms Messages The table below lists the types of alarms that can appear on Root when using O3 Module. Alarm Message Indication Low rSO2 rSO2 level is below low limit. High rSO2 rSO2 level is above high limit. Low Δbase rSO2 level is less than the Delta Baseline low limit.

To troubleshoot issues with Root, see the Operator's Manual for Root. To troubleshoot issues with O3 Sensor, see the Directions for Use for the O3 Sensor. If a problem persists, contact an Authorized Masimo Representative. Troubleshooting O3 Module Message Displayed Possible Cause Action Regional Oximeter Disconnected O3 Module disconnected from Root. Plug in O3 Module to Root again. No Sensor Connected O3 Sensor is not be properly inserted into O3 Module. Confirm that O3 Sensor is securely inserted into O3 Module. For more information about connecting O3 Sensor to O3 Module, see Chapter 3: Setting Up the O3 System on page 19 of the Operator's Manual. O3 Sensor may be defective. Replace O3 Sensor. O3 Module may be defective. Replace O3 Module. Incompatible Sensor O3 Sensor is not properly inserted into O3 Module. Confirm that O3 Sensor is securely inserted into O3 Module. For more information about connecting O3 Sensor to O3 Module, see Chapter 3: Setting Up the O3 System on page 19 of the Operator's Manual. O3 Sensor may have expired. Confirm the expiration date of the O3 Sensor has not passed. O3 Sensor may be defective. Replace O3 Sensor. O3 Module may be defective. Replace O3 Module. Defective Sensor O3 Sensor may be defective. Replace O3 Sensor. Sensor Off Patient O3 Sensor is not properly applied on the patient. Confirm that O3 Sensor is properly applied on the patient. For more information, see Directions for Use for the O3 Sensor. all-guide s.com

Chapter 6: Troubleshooting www.masimo.com 40 Masimo Message Displayed Possible Cause Action O3 Sensor may be defective. Replace O3 Sensor. O3 Module may be defective. Replace O3 Module.

Display Ranges and Resolution Parameter Range Resolution rSO2 0 to 99% 1% ΔSpO2 0 to 99% 1% Δbase 0 to 99% 1% Measurement Accuracy Measurement [1] ARMS rSO2 (trending) [2] 3% (from 45% to 85% SavO2) rSO2 (absolute) [3] 4% (from 45% to 85% SavO2) * The ARMS Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68% of the measured values fell within +/- the ARMS value when compared to the reference device under a controlled study.

Chapter 7: Specifications www.masimo.com 42 Masimo Environment Module Operating Conditions Item Description Temperature at ambient humidity 32˚F to 104˚F (0˚C to 40˚C) Operational Humidity 10% to 95%, non-condensing Module Storage and Shipping Conditions Item Description Temperature at ambient humidity -40˚F to 158˚F (-40˚C to 70˚C) Storage humidity 10% to 95%, non-condensing Altitude Up to 12,000 feet (3700 meters) Physical Characteristics of the Module Item Description Width 2 inches (5.1 centimeters) Length 12 inches (30.5 centimeters) Cable portion: 12 feet (3.7 meters) Thickness 1 inch max (2.5 centimeters) Weight 7 oz. max (200 grams)

Chapter 7: Specifications www.masimo.com 43 Masimo Symbols The following symbols are on the product hardware or packaging. Symbol Description Follow instructions for Use Consult Instructions for Use Separate collection for electronic waste Mark of conformity to European Medical Device Directive 93/42/EEC Federal law restricts this device to sale by or on the order of a licensed physician Authorized Representative in the European Community Storage/transport relative humidity range Storage Temperature Range Atmospheric Pressure Limitation Keep dry Fragile/breakable, handle with care

Chapter 7: Specifications www.masimo.com 44 Masimo Symbol Description Caution Date of Manufacture Manufacturer Non-sterile Type BF Applied Part IPX1 IPX1 Protection against liquid drops falling vertically Catalog number (model number) Serial Number Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available for CE mark countries. all-guide s.com

Chapter 7: Specifications www.masimo.com 45 Masimo Guidance and Manufacturer's Declarations Safety Classifications 1. Type of Protection against Electric Shock of the Module Class II: Electrical equipment in which protection against electric shock does not rely on BASIC INSULATION only, but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being no provision for protective earthing or reliance upon installation conditions. 2. Degree of Protection against Electric Shock of the Module with Sensor An F-type applied part is isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equal to 1.1 times the highest rated AC supply voltage is applied between the applied part and earth. Root incorporates circuitry, creepage and clearance distances from the mains in accordance with EN 60601-1. Root and the sensor provide patient isolation. 3. Degree of Protection against the Ingress of Liquid Both Root and the Module have an ingress of liquid rating of IPX1 (drip proof). 4. Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, or with oxygen or nitrous oxide. 5. Mode of Operation of O3 Module Continuous: The O3 Module may be operated under normal load for an unlimited period, without the specified limits of temperature being exceeded. Safety Compliance Safety Compliance IEC 60601-1, 2nd Ed. EN 60601-2, 2nd Ed. IEC 60601-1, 3rd Ed. EN/ISO 80601-2-61:2011 EMC Compliance EMC Compliance See Operator's Manual for Root.

Chapter 7: Specifications www.masimo.com 46 Masimo Citations [1] The clinical study was done on healthy adult male and female subjects with light to dark skin pigmentation. The trending and absolute rSO2 accuracies were determined by testing in the range of 45% to 85% SavO2 against 30% arterial and 70% jugular venous blood oxygen saturations, measured by a laboratory CO-Oximeter. The study confirms that the O3 System measurements meet the requirements. [2] Trending accuracy is the root mean square relative error. It is calculated by comparing a series of samples to the gold standard and the accuracy refers to how the changes in a series of samples “trend” with the gold standard. The gold standard used was the oxygen saturation calculated from arterial and jugular venous blood gas analysis. [3] Absolute accuracy is the root mean square error where error is the difference between individual samples and a gold standard.

Cleaning Procedure Cleaning of the O3 Module should be performed at regular intervals or in accordance with hospital, as well as local and governmental regulations. See Safety Information, Warnings and Cautions on page 9. O3 Module is a reusable instrument which is supplied non-sterile. To clean the O3 Module • The outer surface of the instrument can be cleaned with a soft cloth dampened with a mild detergent and warm water solution. • Do not allow liquids to enter the interior of the instrument. • The outer surface of the instrument can also be wiped down using any of the following solvents: • Cidex Plus (3.4% glutaraldehyde) • 10% bleach solution • 70% isopropyl alcohol solution General Maintenance for O3 Module Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with hospital, as well as local and governmental regulations. The following is a checklist for the general maintenance of the O3 Module: • Visually inspect equipment for functional or structural damage, including poor seals, cracks, damaged springs, etc. • Visually inspect cables, connectors, and connector pins for signs of damage or wear. • Visually inspect product identification labels to ensure they are clear and legible. Service Instructions O3 Module has no customer serviceable parts. Attempting to service O3 Module will void the warranty. Safety tests and internal adjustments should be done by qualified personnel only. See Sales & End-User License Agreement on page 49. To contact Masimo, see Contacting Masimo on page 49.

Chapter 8: Service and Maintenance www.masimo.com 48 Masimo Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the instrument repaired. Please clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning Procedure on page 47. Make sure the equipment is fully dry before packing. To return the O3 Module for service, please follow the Return Procedure on page 48. Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning Procedure section. Make sure the equipment is fully dry before packing. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely, in the original shipping container if possible, and enclose or include the following information and items: • A letter describing in detail any difficulties experienced with the O3 Module. Include the RMA number in the letter. • Warranty information, a copy of the invoice or other applicable documentation must be included. • Purchase order number to cover repair if the O3 Module is not under warranty, or for tracking purposes if it is. • Ship-to and bill-to information. • Person (name, telephone/Telex/fax number, and country) to contact for any questions about the repairs. • A certificate stating the O3 Module has been decontaminated for bloodborne pathogens. • Return the O3 Module to the shipping address listed in the Contacting Masimo section below.

Chapter 8: Service and Maintenance www.masimo.com 49 Masimo Contacting Masimo To contact Masimo, refer to the following: USA, Canada, and Asia Pacific Europe All Other Locations Masimo Corporation 40 Parker Irvine, California 92618 USA Tel:+1 949 297 7000 Fax:+1 949 297 7001 Masimo International Sàrl Puits-Godet 10 2000 Neuchatel- Switzerland Tel:+41 32 720 1111 Fax: +41 32 724 1448 Contact your local Masimo Representative Sales & End-User License Agreement This document is a legal agreement between you (“purchaser”) and Masimo Corporation (“Masimo”) for the purchase of this Product (“Product”) and a license in the included or embedded Software (“Software”) except as otherwise expressly agreed in a separate contract for the acquisition of this Product, the following terms are the entire agreement between the parties regarding your purchase of this Product. If you do not agree to the terms of this agreement, promptly return the entire Product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund. Warranty Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: each new Product and the Software media as delivered are free from defects in workmanship or materials. Masimo’s sole obligation under this warranty is to replace any product that it deems to be covered under warranty with a replacement O3 Module. Exclusions The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or maintenance needed because of: a) modification of the Product or Software without Masimo’s written authorization; b) supplies, instruments or electrical work external to the Product or not manufactured by Masimo; c) disassembly or reassembly of the Product by anyone other than an authorized Masimo agent; d) use of the Product with sensors or other accessories other than those manufactured and distributed by Masimo; e) use of the Product and Software in ways or in environments for which they are not labeled; and f) neglect, misuse, improper operation, accident, fire, water, vandalism, weather, war, or any act of God. This warranty does not extend to any product that has been used in violation of the operating all-guide s.com

Chapter 8: Service and Maintenance www.masimo.com 50 Masimo instructions supplied with the product. This warranty does not extend to any Product that has been reprocessed, reconditioned or recycled. This warranty also does not apply to any Products provided to Purchaser for testing or demonstration purposes, any temporary Products Modules or any Products for which Seller does not otherwise receive a usage or purchase fee; all such Products are provided AS-IS without warranty. This warranty, together with any other express written warranty that may be issued by Masimo is the sole and exclusive warranty as to the Product and Software. This warranty is expressly in lieu of any oral or implied warranties, including without limitation any implied warranty of merchantability or fitness for a particular purpose. Masimo shall not be liable for any incidental, special or consequential loss, damage or expense directly or indirectly arising from the use or loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product and Software (under contract, warranty, tort, strict liability or other claim) exceed the amount paid by purchaser for the Products giving rise to such claim. The limitations in this section shall not be deemed to preclude any liability that cannot legally be disclaimed by contract. End-User License 1. Grant of License: In consideration of payment of the Software license fee, which is part of the price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable (except as set forth below) license (“License”), without right to sublicense, to use the copy of the Software in connection with Purchaser’s use of the Product for its labeled purpose as set forth in these directions for use. Masimo reserves all rights not expressly granted to Purchaser. 2. Ownership of Software: The Software is licensed not sold; all rights and interests in the Software and all copies thereof remain at all times vested in Masimo, and do not pass to Purchaser. Any references in this Agreement to the purchase or sale of the Software shall be deemed the purchase or sale of a Software License as set forth herein. Restrictions 1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchaser’s failure to abide by the terms of this Agreement. Nothing in this License provides any rights beyond those provided by 17 U.S.C. §117. 2. Use Restrictions: Purchaser may physically transfer the Product from one location to another provided that the Software is not copied. Purchaser may not electronically transfer the Software from the Product to any other device. Purchaser may not disclose, publish, translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Software or the written materials. 3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo’s prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any

Chapter 8: Service and Maintenance www.masimo.com 51 Masimo party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void. 4. U.S. Government Rights: If Purchaser is acquiring Software (including the related documentation) on behalf of any part of the United States Government, the following provisions apply: the Software and documentation are deemed to be "commercial software" and "commercial computer software documentation," respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the Software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables that would, alone, or in combination with the device, fall within the scope of one or more of the patents relating thereto. BY ACCEPTANCE OR USE OF THIS DEVICE, YOU ACKNOWLEDGE YOUR ACCEPTANCE OF THESE TERMS.

Alarms Messages • 38 AUC Index (Area under the Curve) • 23 AUC Settings • 34 B Baseline • 23 Baseline View • 23, 29 Body Sensor Sites • 32 C Chapter 1 Technology • 13 Chapter 2 System Description • 17 Chapter 3 Setting Up the O3 System • 19, 39 Chapter 4 Operation • 23 Chapter 5 Errors and Alarms • 37 Chapter 6 Troubleshooting • 39 Chapter 7 Specifications • 41 Chapter 8 Service and Maintenance • 47 Citations • 46 Cleaning and Service Warnings and Cautions • 12 Cleaning Procedure • 47, 48 Compliance Warnings and Cautions • 12 Components of the Regional Oximetry System • 15 Connecting the O3 Module to Root • 19 Connecting the O3 Sensor(s) to the O3 Module • 21 Contacting Masimo • 47, 49 Contraindication • 7 D Delta Baseline (Δbase) • 23 Delta Baseline (Δbase) Settings • 35 Delta SpO2 (ΔSpO2) • 24 Delta SpO2 (ΔSpO2) Settings • 36 Display and Alarm Settings • 33 Display Options • 26 Display Ranges and Resolution • 41 E EMC Compliance • 45 End-User License • 50 Environment • 42 Exception Messages • 37 Exclusions • 49 G General Maintenance for O3 Module • 47 Guidance and Manufacturer's Declarations • 45 H Head Patient View • 31 I Indications for Use • 7 M Measurement Accuracy • 41 N No Implied License • 51

Index www.masimo.com 54 Masimo O O3 Module and O3 Sensor • 18 Overview • 13 P Performance Warnings and Cautions • 10 Physical Characteristics of the Module • 42 Preparation for Use • 19 Principles of Beer-Lambert Law and Regional Oximetry • 13 Product Description • 7 R Regional Oxygenation (rSO2) • 23 Regional Oxygenation Information • 23 Repair Policy • 48 Restrictions • 50 Return Procedure • 48 Root • 17 rSO2 Settings • 33 S Safety Classifications • 45 Safety Compliance • 45 Safety Information, Warnings and Cautions • 9, 47 Safety Warnings and Cautions • 9 Sales & End-User License Agreement • 47, 49 Service Instructions • 47 Site Selection Menu • 30 Symbols • 43 T The O3 Module Window • 20, 22, 25 Trend View • 26 Troubleshooting O3 Module • 39 U Unpacking and Inspecting the System • 19 W Warranty • 49 all-guide s.com