FCC ID: VKF-MWM2 MWMII

Contents 1 List of applicable FCC rules ......................................................................................................................... 2 2 Summarize the specific operational use conditions .................................................................................. 2 3 Limited module procedures ....................................................................................................................... 2 4 Trace antenna designs ............................................................................................................................... 2 5 RF exposure considerations ....................................................................................................................... 2 6 Antennas .................................................................................................................................................... 2 7 Label and compliance information ............................................................................................................ 2 8 Information on test modes and additional testing requirements ............................................................. 3 9 Additional testing, Part 15 Subpart B disclaimer ....................................................................................... 3 1 1 List of applicable FCC rules MWMII is tested to below:

47 CFR FCC 15.247:2019 - Operation within the bands 902928 MHz, 24002483.5 MHz, and 57255850 MHz 47 CFR FCC 15.407:2019 - General technical requirements 2 Summarize the specific operational use conditions Below antennas are to be used with MWMII Ethertronics 9000129 Ethertronics 1000672 The radio module is intended for professional users. 3 Limited module procedures Not applicable. MWMII module is certified as Single Modular Approval. 4 Trace antenna designs Not applicable. MWMII uses external antennas please refer to section 6. 5 RF exposure considerations MWMII module is intended for mobile application conditions. 6 Antennas MWMII uses one of two (external) antennas: Ethertronics 9000129 and Ethertronics 1000672. Ethertronics 9000129 uses an ultra-small u. Fl. connector with 100 mm long cable and Ethertronics 1000672 uses an ultra-small u. Fl. connector with 200 mm long cable. 7 Label and compliance information Host product manufactures are required to provide physical or e-label stating Contains FCC ID VKF-

MWM2 or equivalent with their finished product. For regulatory information to be provided, refer to 2 the FCC rules that apply to the host product. The label requirements for the RF device depends on the type of the equipment authorization used. So provide regulatory information as appropriate. 8 Information on test modes and additional testing requirements MWMII has been tested in standalone configuration for FCC compliance testing and thus the simultaneous transmission conditions, if applicable, must be evaluated by the integrator. Evaluate compliance for a host using certified modules and/or a stand-alone product requires: addressing EMC requirements for composite system testing and for simultaneous transmission. Host manufactures are required to perform testing for spurious emissions if only one module is installed in the host. Host manufactures are required to perform testing on the product with transmitter or transmitters operating to confirm that the host product meets the FCC requirements. This investigation of the final product can be done by spot checking emissions from the device while operating the host as a composite system (with all the transmitters operating simultaneously). This testing is performed with the host product configured in typical operational modes to check the fundamental-frequency and spurious emissions for compliance with all the applicable rules. Masimo Corporation provides test scripts which allow host to operate for FCC compliance testing. In order to verify the continued FCC compliance, host manufacturers are required to consider test modes for different operational conditions as well as for multiple simultaneous transmitting modules or other transmitters, if any, in a host product. It is host product manufactures responsibility to evaluate compliance. In cases where host product is regulated under different or additional FCC rules, host product manufacturers are required to perform verification testing to confirm that the end product complies with all the accountable FCC compliance requirements. 9 Additional testing, Part 15 Subpart B disclaimer Modular transmitter MWMII is FCC authorized for the rules specified on the grant and the host product manufacturer is responsible for compliance to any other FCC rules that apply to the host not covered by the modular transmitter grant of certification. Host manufactures are required to obtain the equipment authorization of the applicable unintentional radiator functions under part 15 subpart B of the host product, and if required any additional testing and certification for any other included transmitters. 3

Operator's Manual Root temperature with noninvasive blood pressure and For Sale in the USA These operating instructions provide the necessary information for proper operation of all models of the Root. 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 Root are prerequisites for its proper use. Do not operate Root without completely reading and understanding these instructions. If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer. 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. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling. 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 and precautions. Wireless Radio:

Contains: FCC ID: VKF-MWM2 | Model: RDS-7A or RDS-7 | IC: 7362A-MWM2 www.masimo.com 1 Masimo EU authorized representative for Masimo Corporation:

Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH Conforms to ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No. 3149433 60601-1, and applicable Particular (IEC 60601-2-49, IEC 80601-2-30, ISO 80601-2-56) and related Collateral (IEC 60601-1-8:2006) Standards for which the product has been found to comply by Intertek. Patents: www.masimo.com/patents

, Iris, Masimo, MOC-9, PVi, Radical-7, Radius-7, rainbow, Root, RRa, SedLine, SET, Signal Extraction Technology, SpCO, SpHb, and SpMet are federally registered trademarks of Masimo Corporation. ISA, MyView, and SpOC are trademarks of Masimo Corporation. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. respective owners. All other trademarks and registered trademarks are property of their www.masimo.com 2 Masimo 2020 Masimo Corporation www.masimo.com 3 Masimo Contents About This Manual ---------------------------------------------------------- 11 Product Description and Features, Intended Use and Indications for Use 13 Product Description and Features ---------------------------------------- 13 Intended Use -------------------------------------------------------------- 14 Indications for Use -------------------------------------------------------- 14 Contraindication ---------------------------------------------------------- 17 Safety Information, Warnings, and Cautions ------------------------------- 19 Safety Warnings and Cautions ------------------------------------------- 19 Performance Warnings and Cautions ------------------------------------ 24 Cleaning and Service Warnings and Cautions --------------------------- 28 Compliance Warnings and Cautions ------------------------------------- 29 Chapter 1: Description ------------------------------------------------------ 33 Features ------------------------------------------------------------------- 33 Chapter 2: Setting Up ------------------------------------------------------- 39 Unpacking and Inspection ------------------------------------------------ 39 Guidelines for Setting Up ------------------------------------------------ 39 Power On ----------------------------------------------------------------- 41 Initial Battery Charging --------------------------------------------------- 42 Radical-7 Connection ----------------------------------------------------- 44 www.masimo.com 5 Masimo Root NIBPT Contents Radius-7 Connection ----------------------------------------------------- 46 MOC-9 Connection ------------------------------------------------------- 47 Nurse Call Connection---------------------------------------------------- 48 Attach the Probe Well ---------------------------------------------------- 48 Attach the Temperature Probe ------------------------------------------- 49 Attach NIBP Cuff ---------------------------------------------------------- 49 Masimo Kite -------------------------------------------------------------- 49 Bluetooth Devices -------------------------------------------------------- 50 Chapter 3: Operation -------------------------------------------------------- 51 About the Main Screen --------------------------------------------------- 52 About the Status Bar ----------------------------------------------------- 53 About the Action Bar ----------------------------------------------------- 57 Using the Touchscreen Interface ----------------------------------------- 58 Menu Navigation --------------------------------------------------------- 63 Understanding Windows ------------------------------------------------- 64 Accessing Main Menu Options ------------------------------------------ 76 Alarm Interface --------------------------------------------------------- 123 Trend Download -------------------------------------------------------- 129 Session Management --------------------------------------------------- 130 Screen Capture --------------------------------------------------------- 131 Lights -------------------------------------------------------------------- 135 www.masimo.com 6 Masimo Root NIBPT Contents Chapter 4: Temperature Measurement ----------------------------------- 141 Operation - Temperature ----------------------------------------------- 141 Temperature Probes ---------------------------------------------------- 145 Chapter 5: NIBP Measurement -------------------------------------------- 149 Patient Measurement Mode -------------------------------------------- 149 Cuff Selection and Placement ------------------------------------------ 149 Patient Conditions ------------------------------------------------------ 151 Operation - NIBP ------------------------------------------------------- 152 Chapter 6: Admit and Discharge to Patient SafetyNet ------------------- 165 Not Admitted ----------------------------------------------------------- 166 Admitting a Patient ----------------------------------------------------- 167 Discharging a Patient --------------------------------------------------- 168 Not Monitoring Message ----------------------------------------------- 170 Monitoring Resumed Message ----------------------------------------- 171 Chapter 7: Electronic Medical Record (EMR) Push ----------------------- 173 Determining EMR Push is Active --------------------------------------- 173 Manually Entering Patient Data ---------------------------------------- 173 Sending Patient Data to the EMR -------------------------------------- 175 Chapter 8: Radical-7 ------------------------------------------------------- 177 Chapter 9: Radius-7 ------------------------------------------------------- 179 Chapter 10: MOC-9 -------------------------------------------------------- 181 www.masimo.com 7 Masimo Root NIBPT Contents Using MOC-9 Ports ----------------------------------------------------- 182 Chapter 11: Iris ------------------------------------------------------------ 183 Using Iris Connectivity Ports ------------------------------------------- 185 Iris Icon------------------------------------------------------------------ 186 Iris Screen --------------------------------------------------------------- 188 Chapter 12: Bluetooth Devices-------------------------------------------- 191 Connect Device to Root ------------------------------------------------ 191 Chapter 13: Messages ----------------------------------------------------- 193 Chapter 14: Troubleshooting --------------------------------------------- 197 Troubleshooting Radical-7, Radius-7, and MOC-9 Modules ---------- 197 Troubleshooting Root -------------------------------------------------- 197 Chapter 15: Specifications ------------------------------------------------ 203 Measurement Accuracy ------------------------------------------------- 203 Alarms ------------------------------------------------------------------- 204 Nurse Call Specifications ----------------------------------------------- 204 Connectors -------------------------------------------------------------- 205 Display Ranges---------------------------------------------------------- 205 NIBP Pressurization Ranges -------------------------------------------- 207 Electrical ----------------------------------------------------------------- 207 Environmental----------------------------------------------------------- 208 Touchscreen Display ---------------------------------------------------- 209 www.masimo.com 8 Masimo Root NIBPT Contents Wireless Specifications -------------------------------------------------- 209 Compliance-------------------------------------------------------------- 212 Guidance and Manufacturer's Declaration-Electromagnetic Emissions 215 Guidance and Manufacturer's Declaration-Electromagnetic Immunity 217 Recommended Separation Distances ---------------------------------- 221 Symbols ----------------------------------------------------------------- 223 Chapter 16: Service and Maintenance ------------------------------------ 229 Cleaning ----------------------------------------------------------------- 229 Replacing the Fuses ---------------------------------------------------- 229 Power-On Self Test ----------------------------------------------------- 231 NIBP Module Calibration Test ------------------------------------------ 231 Zero Point Calibration -------------------------------------------------- 235 Span Point Calibration -------------------------------------------------- 236 NIBP Air Leak Test ------------------------------------------------------ 238 Overpressure Test ------------------------------------------------------- 240 Nurse Call Setting Connections ---------------------------------------- 245 Battery Test ------------------------------------------------------------- 246 Repair Policy ------------------------------------------------------------ 247 Return Procedure ------------------------------------------------------- 247 Masimo Technical Services --------------------------------------------- 248 Contacting Masimo ----------------------------------------------------- 248 www.masimo.com 9 Masimo Root NIBPT Contents Appendix: Concepts of Alarm Response Delay -------------------------- 253 Concepts of Alarm Response Delay ----------------------------------- 253 Index ----------------------------------------------------------------------- 255 www.masimo.com 10 Masimo About This Manual This manual explains how to set up and use Root with noninvasive blood pressure and temperature . Important safety information relating to general use of Root 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 or user. WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage to other property. CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note. www.masimo.com 11 Masimo Product Description and Features, Intended Use and Indications for Use Product Description and Features Root with noninvasive blood pressure and temperature is a patient monitoring and connectivity platform. It offers multiple high-impact innovations for broad applications across the continuum of care. Instantly interpretable, high-visibility display of Masimos breakthrough SET and rainbow SET measurements. Intuitive, touchscreen navigation for easy and adaptable use in any Flexible measurement expansion through Masimo Open Connect hospital environment.

(MOC-9). Designed for third-party measurement expansion to allow other companies to add to the platform measurements. Built-in network connectivity gateway through Iris for standalone devices such as IV pumps, ventilators, beds, and other patient Docking and charging station for Radical-7 and Radius-7 Battery monitors. Module. Integrated noninvasive blood pressure (NIBP) technology. Optional integrated temperature technology. Ability to display data on a secondary display. Ability to display data from external devices using Bluetooth. www.masimo.com 13 Masimo Root NIBPT Product Description and Features, Intended Use and Indications for Use For all prescribing information and instructions for use of the compatible medical devices that are connected to Root, see Operators Manual or Instructions for Use for the specific medical device. Intended Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station). The Masimo Root Monitoring System can be used with the optional Radical-7, ISA product family, Radius-7, and/or the SedLine module. The Masimo Root Monitoring System is intended to be used with connected measurement modules compatible with Root interfaces. Indications for Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen www.masimo.com 14 Masimo Root NIBPT Product Description and Features, Intended Use and Indications for Use saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices. The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult, and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, and hospital-type facilities. The optional ISA product family consists of three types of side stream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2 Desflurane ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and www.masimo.com 15 Masimo Root NIBPT Product Description and Features, Intended Use and Indications for Use ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric, infant, and neonatal patients. The optional SedLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index

(PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The optional temperature module is indicated to measure temperature

(oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age www.masimo.com 16 Masimo Root NIBPT Product Description and Features, Intended Use and Indications for Use Patient Population Approximate Age Range Infant Child 1 month to 2 years of age 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older Contraindication There are no contraindications. www.masimo.com 17 Masimo Safety Information, Warnings, and Cautions CAUTION: Root 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 Operator's Manuals for ISA, Kite, Patient SafetyNet, Radical-7, Radius-7, TIR-1 and SedLine for additional safety information, warnings, and cautions. Safety Warnings and Cautions WARNING: Do not use Root if it appears or is suspected to be damaged. WARNING: Do not adjust, repair, open, disassemble or modify Root. Injury to personnel or equipment damage could occur. Return Root for servicing. WARNING: Do not use Root during or nearby magnetic resonance imaging

(MRI) or in an MRI environment. WARNING: Do not place Root or accessories in any position that might cause it to fall on the patient. WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. WARNING: Do not use Root in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments or nitrous oxide to avoid risk of explosion. WARNING: To reduce the risk of explosion, only replace battery with Masimo supplied parts. to be correct. WARNING: Do not start or operate the Root unless the setup was verified www.masimo.com 19 Masimo Root NIBPT Safety Information, Warnings, and Cautions Root. WARNING: To ensure safety, only use Masimo authorized devices with WARNING: To protect against fire hazard, replace only with recommended fuses of the same type, current rating, and voltage rating. WARNING: Do not remove the back panel of the device. This could cause injury to personnel or device damage. WARNING: Electrical Shock Hazard: 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. Do not attempt to sterilize the device. Use cleaning solutions only as instructed in this Operator's Manual. Do not attempt to clean the Root while monitoring patient. WARNING: Do not plug in or remove the power cord with wet hands to avoid risk of electric shock. Ensure that your hands are clean and dry before touching the power cord. WARNING: When positioned on a flat surface, the device should be secured with a mounting system recommended by Masimo. WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. CAUTION: Do not place the Root where the controls can be changed by the CAUTION: To ensure patient isolation, connect only Masimo devices that have been designed for Root. www.masimo.com 20 Masimo patient. Root NIBPT Safety Information, Warnings, and Cautions CAUTION: Equipment intended to be connected to signal input/signal output ports should comply with applicable electrical safety standards to further minimize the risk of electric shock. Only devices that have been configured to operate with Root may function properly when connected. CAUTION: Only use the AC power cable provided by Masimo. Using a different AC power cable could cause damage to Root. Check the power cord and plug to ensure that it is intact and undamaged. CAUTION: To avoid risk of electrical shock, this equipment must only be connected to a supply mains with a protective earth connection. Do not under any circumstances remove the grounding conductor from the power plug. CAUTION: Use a grounded outlet for proper equipment grounding. A hospital-grade outlet is required. CAUTION: Do not place Root where the appliance inlet or the AC power plug cannot be readily disconnected. Note: Disconnect the device from AC mains by removing the AC power cord connector from the device inlet. Note: If there is any doubt about the integrity of the protective earth conductor arrangement, operate Root on internal battery power until the AC power supply protective conductor is fully functional. Note: Do not monitor more than a single patient at a time on Root. Note: It is recommended that Root is attached to an AC power source when it is not in use to ensure that the battery remains fully charged. Note: For medical technologies that require AC power, the battery should be adequately charged to ensure backup power in case of AC power disruption. www.masimo.com 21 Masimo Root NIBPT Safety Information, Warnings, and Cautions Noninvasive Blood Pressure WARNING: Frequently check the blood pressure monitoring site to ensure adequate circulation. WARNING: Only use Root in neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. WARNING: Neonatal blood pressure measurements must always use a three (3) meter hose in order to avoid overpressure error caused by lack of air volume within the overall pneumatic system. WARNING: Do not apply the cuff to a limb that is on the same side of a mastectomy. WARNING: Do not use or stop blood pressure measurements if the patient appears to be affected by the pressurization of the cuff due to a physical condition (i.e. pregnant, pre-eclamptic, etc.) WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. WARNING: Do not attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to WARNING: Before applying the cuff on the patient, confirm the cuff size is WARNING: When a blood pressure measurement error code occurs, any blood pressure values reported should be disregarded. CAUTION: Applying the blood pressure cuff over a wound can cause further the patient. appropriate. injury. www.masimo.com 22 Masimo Root NIBPT Safety Information, Warnings, and Cautions CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient. CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse oximeter probe), the pressurization within the cuff can cause temporary loss of function of the monitoring equipment. Optional Integrated Temperature WARNING: Always use single-use disposable probe covers to limit patient cross-contamination and/or patient discomfort. WARNING: Before use, verify the color of the removable probe well to confirm the proper application site: Red (rectal), Blue (oral/axillary). WARNING: The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. WARNING: Do not take axillary temperature through the patient's clothing, direct probe cover-to-skin contact is required. CAUTION: Long-term continuous temperature monitoring, greater than 5 minutes, is not recommended. CAUTION: Ensure probe well is properly in place. CAUTION: Biting the probe tip while taking a temperature may result in damage to the probe. temperature errors. CAUTION: Use of the incorrect probe at the measurement site will result in www.masimo.com 23 Masimo Root NIBPT Safety Information, Warnings, and Cautions Note: If a reliable spot check measurement cannot be made, the temperature module will automatically switch to continuous mode to make the measurement. before use with Root. Note: Verify the compatibility of the temperature probe and probe cover Performance Warnings and Cautions WARNING: Root should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: Root may be used during defibrillation. This may affect the accuracy or availability of the parameters and measurements. WARNING: Root may be used during electrocautery. This may affect the accuracy or availability of the parameters and measurements. WARNING: Wireless communication of alarms to a secondary monitoring station should not be relied upon as a primary alarm. WARNING: Do not place the Root against a surface that may cause the alarm to be muffled. environment. WARNING: Radical-7 may not fully charge in a high ambient temperature WARNING: Always ensure settings including alarms are appropriate for each patient prior to use. WARNING: When using multiple devices in the same or similar environment, use of the same patient profile (including the same alarm presets) to avoid confusion that can lead to patient harm. CAUTION: Ensure the speaker is not covered. www.masimo.com 24 Masimo Root NIBPT Safety Information, Warnings, and Cautions CAUTION: Before using Root under high intensity surgical lights, confirm that the display settings allow for clear display of measurements. CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer. CAUTION: Do not place the Root on electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Root promptly after a Low Battery alarm may result in the device shutting down. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Root. CAUTION: If the Radical-7 or Radius-7 stops communicating with Root, parameters and measurements will not show on the Root; however, this will not affect Radical-7's or Radius-7's ability to monitor the patient. CAUTION: In order to establish and maintain Roots minimum Quality of Service, the following network specifications should be met before and after installation:

Wired Network Connection During Ping Test, passing result if:

b. No more than 2 % packets loss. Wireless Network Connection During Ping Test, passing result if:

a. At least 98% of packets have latency 30 milliseconds, and a. At least 98% of packets have latency 100 milliseconds, b. No more than 2 % packets loss, and c. Primary access point signal strength at least -67 dBm. www.masimo.com 25 Masimo Root NIBPT Safety Information, Warnings, and Cautions CAUTION: The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID, MRI, electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength. Note: Root is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Roots alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Roots primary alarms. Note: When the Root monitor is in synchronized waveform view, the EEG Chart Speed of the SedLine Window cannot be changed. Noninvasive Blood Pressure WARNING: Before applying the cuff on the patient, confirm the cuff size is appropriate. WARNING: When a blood pressure measurement error code occurs, any blood pressure values reported should be disregarded. CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse oximeter probe), the pressurization within the cuff can cause temporary loss of function of the monitoring equipment. www.masimo.com 26 Masimo Root NIBPT Safety Information, Warnings, and Cautions Optional Integrated Temperature WARNING: The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. WARNING: Do not take axillary temperature through the patient's clothing, direct probe-cover-to-skin contact is required. CAUTION: Long-term continuous temperature monitoring, greater than 5 minutes, is not recommended. CAUTION: Ensure probe well is properly in place. CAUTION: Biting the probe tip while taking a temperature may result in CAUTION: Use of the incorrect probe at the measurement site will result in Note: If a reliable spot check measurement cannot be made, the temperature module will automatically switch to continuous mode to make Note: Verify the compatibility of the temperature probe and probe cover damage to the probe. temperature errors. the measurement. before use with Root. Kite exists. WARNING: When using Root the Kite accessory does not generate or manage alarms. The Root alarms, used in conjunction with clinical signs and symptoms, are the primary sources for determining that an alarm condition www.masimo.com 27 Masimo Root NIBPT Safety Information, Warnings, and Cautions CAUTION: Kite is not a primary display. Medical decisions should be made using data from the primary display of a device in conjunction with clinical signs and symptoms. Patient SafetyNet System Note: The wireless communication status between Root and Patient SafetyNet is displayed by Patient SafetyNet. Cleaning and Service Warnings and Cautions WARNING: Electrical Shock Hazard: The Root battery should be installed and/or removed from Root only by qualified personnel. WARNING: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Root. These substances affect the devices materials and device failure can result. CAUTION: Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display. CAUTION: Do not submerge the Root in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. CAUTION: To prevent damage to the temperature probe do not autoclave. CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any AC power source. www.masimo.com 28 Masimo Root NIBPT Safety Information, Warnings, and Cautions 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. CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. Note: Excessive cleaning solution can flow into the device and cause damage to internal components. Compliance Warnings and Cautions WARNING: Changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the users authority to operate the equipment. WARNING: Do not incinerate the battery. WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. WARNING: Users are advised that high-power radars are allocated as primary users (i.e. priority users) of the bands 5.25-5.35 GHz and 5.65-5.85 www.masimo.com 29 Masimo Root NIBPT Safety Information, Warnings, and Cautions GHz and that these radars could cause interference and/or damage to LE-LAN devices. CAUTION: Consideration to the compliance of the IEC 60601-1-1 standard should be made when configuring Root as part of a Medical System. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. in the Operator's Manual. Note: Use Root in accordance with the Environmental Specifications section Note: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. If this equipment does cause harmful interference to radio or television, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

www.masimo.com 30 Masimo Root NIBPT Safety Information, Warnings, and Cautions Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Note: To satisfy RF exposure requirements, this device and its antenna must operate with a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Note: This equipment has been tested and found to comply with the Class A limits for medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a hospital environment. Note: This Class A digital apparatus complies with Canadian ICES-003. Note: This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. healthcare facility. Note: Root is not intended for use during patient transport outside the www.masimo.com 31 Masimo Chapter 1: Description Root can be used in the following ways:

As a docking station and charger for Radical-7 and Radius-7 Battery Module. As a bedside monitoring display for parameters on Radical-7, Radius-7, and MOC-9 modules. As a bedside monitor for continuous or non-continuous NIBP and temperature. second. Note: Continuous Mode will take a measurement every one (1) As a connectivity gateway for standalone devices. Features Front View www.masimo.com 33 Masimo Root NIBPT Chapter 1: Description Ref. Feature Description Provides a docking station for the Radical-7 and Radius-7 (Note: Battery Charging Adapter required 1 Docking Station for Radius-7). While docked, the Radical-7 can communicate monitored parameters and measurements.*

Root Display 2 and Touchscreen interactions. Provides a frontal display and interface for user 3 Home Button Provides access to the Main Screen. Root Charging Indicator AC Power Indicator Radical-7 6 Charging Indicator Shows an indication of the battery charge for Root. Shows an indication of AC power connection Root. Shows an indication of battery charge for the Radical-7 in the Docking Station.

*Only the touchscreen version of the Radical-7 is able to communicate monitored parameters and measurements. All other versions can only charge in the docking station but not communicate with Root. www.masimo.com 34 Masimo 4 5 Root NIBPT Back View Chapter 1: Description Ref. Feature Description 1 Handle Allows the user to transport Root. 2 Speaker Provides audible notification. 3 Nurse Call Connector Provides a connection to a Nurse Call system. 4 Ethernet Port RJ-45 cable. Provides a network connection to Root using an 5 USB Ports (2) Provide USB 2.0 connectivity. www.masimo.com 35 Masimo Root NIBPT Chapter 1: Description Ref. Feature Description Power Entry Contains the input connector for a hospital grade Module AC power cord and the fuse holder. Equipotential 7 Ground Connector Provides optional functional earthing for Root to eliminate potential differences. The use of the Equipotential Ground Connector should be in accordance with IEC 60601-1. Iris Connectivity Ports (4) Provide connection for standalone devices. www.masimo.com 36 Masimo 6 8 Root NIBPT Side Views Chapter 1: Description Left Side Right Side Ref. Feature Description 1 System Status Lights messages and alarm priority. See System Provides an indication of system Status Lights on page 135. 2 Power Button Places Root in Power On, Sleep, and Power Off modes. 3 MOC-9 Ports (3) Provide connectivity for MOC-9 modules. www.masimo.com 37 Masimo Root NIBPT Chapter 1: Description 4 NIBP Nib Connection port for NIBP Hose. 5 Temperature Probe Port*

to Root. Allows connection of temperature probe Temperature Probe Well Provides dock for temperature probe 6 Holder*

when not measuring. 7 Probe Covers Holder access. Holds extra probe covers for quick

*This feature is optional on Root. www.masimo.com 38 Masimo Chapter 2: Setting Up Unpacking and Inspection To unpack and inspect Root 1. Remove Root from the shipping carton and examine it for signs of shipping damage or exposed electronics. 2. Confirm that you have all components for the Root by checking all materials against the packing list:

Root AC power cord Note: 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 Masimo's Technical Service Department. See Return Procedure on page 247. Guidelines for Setting Up Root has a built-in bracket interface that allows it to be mounted on a pole or roll stand. When setting up Root, follow these guidelines:

Place on a stable, hard, flat, and dry surface near the patient. Maintain a minimum of three (3) centimeters (one [1] inch) of free Ensure that the back panel speaker is not covered to avoid a space around Root. muffled alarm sound. www.masimo.com 39 Masimo Root NIBPT Chapter 2: Setting Up Charge Root's battery fully before use. See Initial Battery Charging on page 42. Root should not be operated outside the environmental conditions listed in the specifications section. See Environmental on page 208. www.masimo.com 40 Masimo Root NIBPT Chapter 2: Setting Up Power On tone sounds. The Power Button can be used for Power On, Sleep, and Power Off. To Power On, press the Power Button for two (2) seconds until a single audible Once Root turns on, if no Radical-7, Radius-7, or MOC-9 module is connected, the Root display shows the following message: Please Connect a Device. The user is now able to connect Radical-7, Radius-7, and MOC-9 module. www.masimo.com 41 Masimo Root NIBPT Chapter 2: Setting Up For information about Sleep Mode and Power Off, see Sleep and Power Off on page 138. Initial Battery Charging To charge the battery for the first time 1. Securely plug the AC power cord into power entry module. 2. Plug the hospital grade AC power cord into an AC power source. 3. Verify that Root's battery is charging by ensuring that the AC Power Indicator (1) is green and the Battery icon on the Status Bar

(2) is solid green or has the charging symbol. See AC Power Indicator on page 136 and About the Status Bar on page 53.

(1)

(2) www.masimo.com 42 Masimo Root NIBPT Chapter 2: Setting Up 4. The Root Charging Indicator remains orange while the battery is charging and will illuminate green when Root is fully charged. See Root Battery on page 109 and About the Status Bar on page 53. See Safety Information, Warnings, and Cautions on page 19. www.masimo.com 43 Masimo Root NIBPT Chapter 2: Setting Up Radical-7 Connection It is recommended that Root be powered on before performing the steps below. 1. Snap the Radical-7 into the Docking Station. 2. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to power it on. 3. When properly connected, the Radical-7 Charging Indicator light will illuminate. An illuminated Radical-7 Battery icon will also appear in the Status Bar. See About the Status Bar on page 53 4. Root display will show active measurements and parameters. For Radical-7 charging conditions, see Radical-7 and Radius-7 Charging Indicator on page 137. www.masimo.com 44 Masimo Root NIBPT Chapter 2: Setting Up www.masimo.com 45 Masimo Chapter 2: Setting Up Root NIBPT below. Radius-7 Connection It is recommended that Root be powered on before performing the steps 1. Ensure the Radius-7 Battery Charging Adapter is properly docked in the Docking Station area of Root. 2. Activate the Bluetooth radio on Root. (for more information see Operators Manual for Radius-7). 3. Place the Radius-7 Battery Module into the charging area of the Radius-7 Battery Charging Adapter. 4. Root will emit a tone when pairing has completed (see Operator's Manual for Radius-7 for more information). 5. When properly connected, an illuminated Radius-7 Battery icon will appear in the Status Bar, and the rainbow Window will appear on the Root display. www.masimo.com 46 Masimo Root NIBPT MOC-9 Connection Chapter 2: Setting Up To connect a MOC-9 module to Root 1. Identify the Masimo Open Connect (MOC-9) end of the module. 2. Insert the MOC-9 end of the module securely into a MOC-9 port on Root. For more information about MOC-9 modules, see Chapter 10: MOC-9 on www.masimo.com 47 Masimo page 181. Root NIBPT Chapter 2: Setting Up Nurse Call Connection Use a Nurse Call connection cable to connect to a Nurse Call System. To connect to a Nurse Call System 1. Identify the Nurse Call connection end (1/4 inch round female 2. Insert the Nurse Call connection cable securely into the compatible connector) of the cable. port on Root. 3. Depending on the connection type of the Nurse Call System, it may be necessary to orient the other end of the Nurse Call connection cable to fit correctly into the system connection. 4. For more information, see Device Output on page 116. Attach the Probe Well For a list of compatible temperature probes and accessories, visit http://www.masimo.com/. 1. Align the probe well with the tabs facing up and down and insert the probe well into the temperature module. Note: The probe well snaps into place when it is fully seated. 2. Insert the temperature probe into the probe well. www.masimo.com 48 Masimo Root NIBPT Chapter 2: Setting Up Attach the Temperature Probe 1. Hold the temperature probe cable connector with the spring tab on the right and insert it into the probe port of the temperature 2. Push the cable connector into place until it clicks. 3. Place probe cover onto the temperature probe and dock in the module. probe well. Attach NIBP Cuff For a list of compatible NIBP patient hoses and cuffs, visit http://www.masimo.com/. 1. Attach an adapter to the end of the cuff hose (if necessary). 2. Connect blood pressure cuff to the NIBP Nib located on the side of Root. See Chapter 5: NIBP Measurement on page 149. Masimo Kite Masimo Kite Software Application is a passive monitoring interface to Point-of-Care (POC) Masimo medical devices (Root for example) that co-exist under the same Wi-Fi network. Kite remotely displays system and parameter status reported by the POC device on a separate monitor. Root must be on the same network as Kite. Note: If the device is not on the same network, it can be added, but Kite will not be able to connect it to view the parameters monitored by that device until both Kite and the device are connected to the same network. www.masimo.com 49 Masimo Root NIBPT Chapter 2: Setting Up To add Root to Kite to view parameter status, refer to the Masimo Kite Software Application Operator's Manual. Bluetooth Devices External devices can be connected to Root through Bluetooth. For more information about connecting an external device to Root through Bluetooth, see Chapter 12: Bluetooth Devices on page 191. www.masimo.com 50 Masimo Chapter 3: Operation The information in this chapter assumes that Root is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Root without completely reading and understanding these instructions. www.masimo.com 51 Masimo Root NIBPT About the Main Screen Chapter 3: Operation The Main Screen consists of several features. The following shows the Main Screen when two different devices are connected: Radical-7 (top) showing rainbow parameters and measurements, SedLine module (middle) showing brain function measurements. www.masimo.com 52 Masimo Root NIBPT Ref. Feature Description Chapter 3: Operation Displays system status as well as icons that provide shortcuts to menu items or actions. See About the Status Bar on page 1 Status Bar 53. Provides a dynamic, user-configurable display area for all the 2 Windows data from connected medical devices. Action Bar 3 Provides icons for access to Root options for Patient Admit, EMR Push, Session Management, Manual Events and the Main Menu. See Accessing Main Menu Options on page 76. About the Status Bar At the top of the Main Screen is the Status Bar with interactive icons. Each icon provides a shortcut to a menu item or an action on Root. An example is shown below. Ref. Feature Description Displays alarm status and temporarily mutes all audible alarms for Root, Radical-7, Radius-7, and MOC-9 1 Alarm Silence modules. See Alarm Silence on page 125. www.masimo.com 53 Masimo Root NIBPT Ref. Feature Description Chapter 3: Operation Displays Audio Pause status and temporarily silences an 2 Audio Pause alarm event. See Audio Pause on page 126. Allows for patient monitoring to be temporarily suspended. Available when using Root with Radical-7 or 3 Standby Mode Radius-7. See Standby Mode on page 128. Provides access to the Device Output screen for activation or deactivation of nurse call functions, USB port output formats, and IntelliBridge connection. If this icon is visible, then USB port 1 and/or USB port 2 are 4 Device Output activated. See Device Output on page 116. Provides access to the Kite screen for activation or deactivation of Kite connection. If this icon is visible, then 5 Kite Kite connectivity has been enabled. See Kite on page 104. Provides access to the Bluetooth screen. If this icon is 6 Bluetooth visible, then Bluetooth connectivity has been enabled. See Bluetooth on page 108. www.masimo.com 54 Masimo Root NIBPT Ref. Feature Description Chapter 3: Operation Provides access to the Wi-Fi screen. If this icon is visible, then wireless connectivity has been enabled. The icon 7 Wi-Fi also indicates signal strength and Patient SafetyNet connectivity. See Wi-Fi on page 105. Provides access to the Ethernet screen. If this icon is 8 Ethernet visible, then Ethernet connectivity has been enabled. See Ethernet on page 107. 9 Iris disconnected. Provides access to the Iris screen. The example shown above indicates that a standalone device is connected to Port 1 and the information is being sent to Patient SafetyNet or Connectivity Gateway. Ports 2, 3, and 4 are The color of the Iris icon matches the status colors of connected standalone devices on the Iris screen. See Chapter 11: Iris on page 183. Displays charging status for Radical-7 or Radius-7 and Radical-7 or provides access to the Battery Radical-7 screen. The example shows that the battery is currently charging. 10 Radius-7 Battery See Radical-7 and Radius-7 Charging Indicator on page 137. www.masimo.com 55 Masimo Root NIBPT Chapter 3: Operation Ref. Feature Description Displays charging status for Root and provides access to the Battery Root screen. The example shows that the 11 Root Battery battery is currently charging. See Root Charging Indicator on page 137. Provides access to the Sounds screen to adjust alarm and pulse tone volume. This icon does not indicate the actual 12 Sounds volume level of the alarm and pulse tone. See Sounds on page 99. Displays the current time and provides access to the Localization screen which contains settings related to 13 Current Time local time, language and geography. See Localization on page 103. Provides access to the Profiles screen. The example shown illustrates that Profiles is currently set to Adult for 14 Profiles an adult patient. See Profiles on page 121. www.masimo.com 56 Masimo Root NIBPT About the Action Bar Chapter 3: Operation At the bottom of the Main Screen is the Action Bar with interactive icons. Each icon provides a shortcut to a menu item or an action on Root. Ref. Feature Description Patient 1 Admit/Discharge*

on page 165 Provides access to admit or discharge a patient. See Admit and Discharge to Patient SafetyNet. 2 EMR Push*

entered patient parameter data. See Electronic Provides access to send measured or manually Medical Record (EMR) Push on page 173. Session Provides access to Session Management. See Management Session Management on page 129. 4 Manual Events Provides access for manual event markers. 5 Main Menu and connected medical devices. See Accessing Provides access to device control options for Root Main Menu Options on page 76.

*These icons will only appear when Root is connected to a Patient SafetyNet system v5.0.0.0 or higher or an Iris Gateway system. www.masimo.com 57 Masimo 3 Root NIBPT Using the Touchscreen Interface Chapter 3: Operation Use the gestures described below to customize the viewing experience, including displaying the highest priority parameters and measurements. The availability of navigation features is dependent on the connected medical Action Illustration Example Description Press and release. Action performed once finger is released. Press, move (left, right, up or down), and release. Moves an object across the display. Press, move (left, right, up or down), and release quickly. Press, move, and release two points. Moving points apart zooms in, and moving them together zooms out. devices. Press Slide Swipe Pinch Drag and Drop See Customizing Windows on page 72. Press, hold, drag an object to desired position, and drop it by releasing. www.masimo.com 58 Masimo Root NIBPT Chapter 3: Operation Below is a list of all the different types of controls available on Root and the various ways to interact with each type of control. Control Applicable Actions Description Toggle Slide knob Switches between toggle states Press left or right of Quickly moves knob left or right Labeled Toggle Slide knob Switches between toggle states Press left or right of Quickly moves knob left or right toggle toggle Press label Quickly moves knob left or right Spinner Press center When closed, expands the spinner

(focused) tile When open, collapses the spinner Swipe up or down When open, scrolls through spinner tiles Press unfocused tile When open, scrolls tile into center

(focused) position Press anywhere When open, collapses spinner outside spinner Slider Slide knob Moves knob www.masimo.com 59 Masimo Root NIBPT Chapter 3: Operation Control Applicable Actions Description Press anywhere Quickly moves knob to Tap position along slider path Slider Spinner Slide knob Moves knob Press anywhere Quickly moves knob to Tap position along slider path Press center When closed, expands the spinner

(focused) tile When open, collapses the spinner Swipe up/down When open, scrolls through spinner tiles Press unfocused tile When open, scrolls tile into center

(focused) position Press anywhere When open, collapses spinner outside spinner Button Press Performs action (as defined by the button description) Icon Menu Press tile Opens menu specified by tile Swipe left or right Scrolls icons left or right

(anywhere) Press bottom Quickly centers tile corresponding to indicator icon indicator icon www.masimo.com 60 Masimo Root NIBPT Chapter 3: Operation Control Applicable Actions Description Window Press parameter or When no parameter or measurement measurement alarm is present, opens parameter or measurement menu When parameter or measurement alarm is present, silences parameter or measurement alarm Press and hold Enables parameter and measurement drag and drop Well Press parameter or When no parameter or measurement measurement alarm is present, opens parameter or measurement menu When parameter or measurement alarm is present, silences parameter or measurement alarm Press and hold Enables parameter and measurement drag and drop Live Swipe down Separates pleth and acoustic waveforms Waveform Swipe up Combines pleth and acoustic waveforms Trend Line Pinch in Zooms in Pinch out Zooms out Pan Changes time range www.masimo.com 61 Masimo Root NIBPT Chapter 3: Operation Control Applicable Actions Description Press y-axis Opens parameter or measurement trend menu Trend Zoom Press '+'

Increases time range Press '-'

Decreases time range Press time label Resets time range to default Alarm Silence Press Silences all alarms icon icon Bar icons Audio Pause Press Enables Audio Pause Other Status Press Opens relevant menu Back Arrow Press Exits menu, abandons any changes www.masimo.com 62 Masimo Root NIBPT Chapter 3: Operation Menu Navigation When navigating through menus and configuring settings, all changes must be confirmed by selecting OK. To cancel the changes, select Cancel. Any screen requiring selection of option(s) will time out after one (1) minute of inactivity and return to the Main Screen. To navigate to the previous screen, press the arrow at the top left corner of the touchscreen. To return to the Main Screen, at any time, press the Home Button at any time. The Home Button is always illuminated when Root is powered on. www.masimo.com 63 Masimo Root NIBPT Understanding Windows Chapter 3: Operation Root creates a Window for Radical-7, Radius-7, and compatible medical devices that are connected to Root. Parameters or measurements can be expanded or minimized within a Window to customize view. Radical-7 Windows are shown in the examples below. Windows provide waveforms along with either a Trend View or an Analog View. Trend View displays each parameter or measurement alongside a graph of its values over time. Analog View displays values in relation to alarm ranges. Details about the displayed information of parameters and measurements can be found in the directions for use or Operator's Manual of Radical-7, Radius-7, and MOC-9 modules. Trend View Analog View www.masimo.com 64 Masimo Root NIBPT Chapter 3: Operation Ref. Feature Description 1 Window or connected MOC-9 module are displayed. The area where all data from a docked Radical-7, Radius-7, This menu allows the user to change between Trend View 2 Action and Analog View. For NIBP and Temperature, the action Menu menu allows access to additional settings. Sensitivity settings can also be selected through the action menu. 3 Waveform Radical-7, Radius-7, and MOC-9 modules). Shows a parameter or measurement over time (only for

(Available only in Trend View) Parameters and 4a Trend Display measurements are shown as Trend Displays in Trend View. A parameter or measurement's Trend Display includes its Value Range, Numeric Value, Alarm Limits and Parameter label. See Using Trend View on page 66. www.masimo.com 65 Masimo Root NIBPT Chapter 3: Operation Ref. Feature Description

(Available only in Analog View) Parameters and measurements are shown as Analog Gauges in Analog 4b Analog View. A parameter's Analog Gauge includes its Alarm Limits, Gauge Numeric Value, Parameter Label, as well as Alarming, Caution and Normal Ranges. See Using Analog View on page 68. 5 Well Displays parameters and measurements which are not shown as Trend Displays or Analog Gauges. www.masimo.com 66 Masimo Chapter 3: Operation Root NIBPT Using Trend View values over time. In Trend View, a parameter or measurement is displayed as a graph of its The following diagram and table describe key features of a parameter's Trend Display in Trend View. Ref. Feature Description 1 Value Range Indicates current viewing of the parameter or measurement. Press to access the Trend menu where the minimum and maximum of the range can be modified. 2 Trend Graph of time. Zoom in and out of a Trend Graph by Displays parameter and measurement over a period pinching out and in. 3 Numeric Value measurement. Indicates current reading of the parameter or 4 Alarm Limits or measurement, if supported. Indicate high and low alarm limits for the parameter Parameter or 5 Measurement Label Indicates the name of the parameter or measurement. www.masimo.com 67 Masimo Root NIBPT Chapter 3: Operation www.masimo.com 68 Masimo Root NIBPT Using Analog View Chapter 3: Operation The Analog View shows parameter and measurement data as a needle pointing to graduations in a circular array around a dial. This view provides indications of change that can be interpreted at a quick glance. Analog View displays alarming and normal ranges of a parameter or measurement. These indicators can be used to alert clinicians to a patient's condition. To understand specific parameters or measurements, refer to the directions for use or operator's manuals for Radical-7, Radius-7, and the appropriate MOC-9 module(s). The following diagrams and tables describe key features of a parameter's Gauge in Analog View. When alarm limits for a specific parameter or measurement are set, the corresponding Analog gauge re-orients itself. General features of the Analog View are:

Ref. Feature Description 1 Needle measurement. Indicates current status of a parameter or www.masimo.com 69 Masimo Root NIBPT Ref. Feature Description Chapter 3: Operation 2 Alarm Limits measurement. Indicate high and low alarm limits for the parameter or 3 Numeric Value measurement. Indicates current reading of the parameter or 4 Measurement Indicates the name of the parameter or measurement. Parameter or Label www.masimo.com 70 Masimo Root NIBPT Chapter 3: Operation 1 2 3 Specific ranges of the Analog View are:

Ref. Feature Color Description Area of the display range where an alarm will not White be triggered. Area of the display range that provides a caution Normal Range Caution Range Alarming Range Yellow indicator. Red triggered. Area of the display range where an alarm will be Some ranges display as quarter circles, others display as half circles. A quarter circle displays when the value has a physiologic normal level at one end of the range. A half circle displays when the value has a physiologic normal level in the middle of the display range. In the example below, the SpO2 gauge is shown as a quarter circle, where values lower than 88% will trigger an alarm, and the PR gauge is shown as a half circle, where values below 50 bpm and above 140 bpm will trigger an alarm. www.masimo.com 71 Masimo Root NIBPT Chapter 3: Operation Quarter Circle Half Circle www.masimo.com 72 Masimo Root NIBPT Customizing Windows Chapter 3: Operation Windows can be customized by expanding and minimizing parameters and measurements in both Trend View and Analog View. When a parameter is minimized, it is only displayed in the Well with its Numeric Value and Parameter Label. When a parameter is expanded, it will be shown as either a Trend Display or Gauge. To expand a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it dims. Step 2 Drag the Numeric Value over any Trend Display. www.masimo.com 73 Masimo Root NIBPT Chapter 3: Operation Order Instruction Step 3 Release the Numeric Value. Minimizing a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it shrinks. Step 2 Drag the Numeric Value to the Well. Step 3 Release the Numeric Value. www.masimo.com 74 Masimo Chapter 3: Operation Root NIBPT Screen. Manual Sizing of Windows Expanding and minimizing of windows can be performed from the Main www.masimo.com 75 Masimo Root NIBPT Chapter 3: Operation Steps Instruction 1 Press and hold the header bar of the window to be resized to activate the feature. Window borders turn blue for all windows visible on the main screen. 2 Touch the up arrow to expand the selected window. 3 Touch the down arrow to minimize the selected window. Note: The selected window can also be resized by touching the bar with an up or down arrow and dragging to resize. Accessing Main Menu Options To access the Main Menu options At the bottom right corner of the touchscreen, press the Main Menu icon. The Main Menu options are:

Layout rainbow See Layout on page 78. See Rainbow on page 84 www.masimo.com 76 Masimo Root NIBPT Chapter 3: Operation Temperature See Temperature on page 84. See NIBP on page 90. NIBP Sounds See Sounds on page 99. Device Settings See Device Settings on page 102. About See About on page 119. Trend Settings See Trend Settings on page 120. See Profiles on page 121. Profiles Iris See Chapter 11: Iris on page 183. www.masimo.com 77 Masimo Root NIBPT Chapter 3: Operation The Layout menu allows the user to view and customize settings for the main screen layout by changing any of the following options:

Available Layouts See Available Layouts on page 78. Active Channels See Active Channels on page 80. Additional Settings See Additional Settings on page 81. Layout www.masimo.com 78 Masimo Root NIBPT Available Layouts Chapter 3: Operation From the Layout screen, touch Available Layouts. When a Radical-7 or Radius-7 is docked to Root and/or multiple MOC-9 modules are connected to Root, the user will have the option to select from several pre-configured layouts. The image below is an example of Available Layouts in Root with Radical-7 docked. www.masimo.com 79 Masimo Root NIBPT Chapter 3: Operation Note: The rainbow window can be viewed on a Radical-7, using software v1.5.3.5 or greater, in several of the pre-configured layouts. Active Channels From the Layout screen, press Active Channels. www.masimo.com 80 Masimo Root NIBPT Chapter 3: Operation In the Active Channels screen, Temperature and NIBP can be enabled to display on the Root main screen. Factory User Settings Settings Ref Option Description Default Configurable 1 Temperature temperature window on enabled Enables/disables the the Root main screen. Enables/disables the NIBP 2 NIBP window on the Root main enabled screen. enabled or disabled enabled or disabled www.masimo.com 81 Masimo Root NIBPT Chapter 3: Operation Additional Settings for Layouts following options:

From the Layout screen, press Additional Settings. Change any of the Option Description Factory User Configurable Default Settings Settings Trend Controls the sizing of Trend Layout Displays. Dynamic Fixed or Dynamic Analog Range Controls Analog Range Setting. Fixed Fixed or Dynamic The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View. www.masimo.com 82 Masimo Root NIBPT Chapter 3: Operation Fixed Ref. Description Dynamic Ref. Description 1 A set number of Trend Displays can be shown at the same time and all Trend Displays are fixed in size. Every additional parameter or measurement expanded will replace an existing Trend Display. For more information about expanding parameters, see Customizing Windows on page 72. 2 Size of each Trend Display is fixed. 1 Size of all Trend Displays decreases or increases to accommodate parameter(s) expanded or minimized. All Trend Displays are always evenly sized.*

For more information about expanding and minimizing parameters, see Customizing Windows on page 72. 2

*Size of each Trend Display is automatically adjusted.

*When the number of Trend Displays reaches maximum viewing capacity, additional parameters expanded will result in the replacement of existing Trend Displays. www.masimo.com 83 Masimo Chapter 3: Operation Root NIBPT Rainbow Temperature The rainbow icon is displayed only when a Radical-7 or Radius-7 is docked to Root. See Operator manuals for Radical-7 or Radius-7. The Temperature menu allows the user to view and customize settings for the Temperature module by changing any of the following options:

See Alarms for Temperature on page 84. Alarms Trends See Trends for Temperature on page 86. Additional Settings See Additional Settings for Temperature on page 88. Alarms for Temperature www.masimo.com 84 Masimo Chapter 3: Operation From the Temperature screen, touch Alarms, and then change any of the Root NIBPT following options:

Options Description Alarm Priority Factory Default Settings Configurable Options High Limit

(F) The High Limit is triggers an alarm. upper threshold that Medium Off Low Limit

(F) Low Limit is the lower threshold that Medium Off triggers an alarm. High Limit

(C) The High Limit is triggers an alarm. upper threshold that Medium Off Low Limit

(C) Low Limit is the lower threshold that Medium Off triggers an alarm. 80.20-109.9 in steps of 0.1, or Off When set to Off, alarm is disabled 80.1-109.8 in steps of 0.1, or Off When set to Off, alarm is disabled 26.9-43.2 in steps of 0.1, or Off When set to Off, alarm is disabled 26.8-43.1 in steps of 0.1, or Off When set to Off, alarm is disabled www.masimo.com 85 Masimo Root NIBPT Chapter 3: Operation Options Description Alarm Priority Factory Default Settings Configurable Options High Limit

(F) The High Limit is triggers an alarm. upper threshold that Medium Off Silence Duration Temporarily suspend audible alarms for a None 2 min period of time. 80.20-109.9 in steps of 0.1, or Off When set to Off, alarm is disabled 30 sec, 1 min, 2 min, 5 min www.masimo.com 86 Masimo Chapter 3: Operation Root NIBPT Trends for Temperature following options:

Options Description From the Temperature screen, touch Trends, and then change any of the Factory Default Settings Configurable Options The Temperature Trend Max. The upper limit a measurement will be 110.0 The Temperature Trend Min. The lower limit a measurement will be 80.0 The Temperature Trend Max. The upper limit a measurement will be 43.3 The Temperature Trend Min. The lower limit a measurement will be 26.7 80.1-110.0 in steps of 0.1 80.0-109.9 in steps of 0.1 26.8-43.3 in steps of 0.1 26.7-43.2 in steps of 0.1 Y-Axis Max (F) Y-Axis Min (F) shown. shown. Y-Axis Max (C) shown. Y-Axis Min (C) shown. www.masimo.com 87 Masimo Root NIBPT Chapter 3: Operation www.masimo.com 88 Masimo Chapter 3: Operation Additional Settings for Temperature Root NIBPT From the Temperature screen, touch Additional Settings, and then change any of the following options:

Options Description Default Configurable Factory User Settings Settings Unit of The unit of measure for Measure temperature. F F, C Probe Mode A patient-specific probe setting. Oral Oral, Adult Ax, Pediatric Ax Continuous Mode measurement is used to Start None Provides continuous temperature readings through a direct measurement. Direct continuously read temperatures until it reaches the thermal steady state. (unchanging). Measurement Spot Check timing Timeout customization. 5 minutes 5, 10, 15, 30, 60 and 90 minutes Note: No menu is given when rectal probe is used. www.masimo.com 89 Masimo Root NIBPT Chapter 3: Operation www.masimo.com 90 Masimo Root NIBPT Chapter 3: Operation NIBP The NIBP menu allows the user to view and customize settings for the NIBP module by changing any of the following options:

Parameter Settings See Parameter Settings for NIBP on page 91. Intervals See Intervals for NIBP on page 96. Additional Settings See Additional Settings for NIBP on page 99. Calibration See Calibration for NIBP on page 99. Parameter Settings for NIBP From the NIBP screen, touch Parameter Settings, and then change individual parameter settings/alarms by selecting one the following parameters:

Systolic/Diastolic See Systolic/Diastolic (SYS/DIA) on page 92. www.masimo.com 91 Masimo Root NIBPT Chapter 3: Operation Pulse Rate See Pulse Rate (PR) on page 94. Mean Arterial Pressure See Mean Arterial Pressure (MAP) on page 95. Systolic/Diastolic (SYS/DIA) From the Systolic/Diastolic screen, touch Alarms, and then change any of the following options:

Options Description Alarm Priority Factory Default Settings Configurable Options The High Limit is upper threshold that triggers an Medium 220 Systolic High Limit alarm. Low Limit is the lower threshold that triggers an Medium 75 Systolic Low Limit alarm. 42-259 in steps of 1, or Off When set to Off, alarm is disabled 41-258 in steps of 1, or Off When set to Off, alarm is disabled www.masimo.com 92 Masimo Root NIBPT Chapter 3: Operation Options Description Alarm Priority Factory Default Settings Configurable Options The High Limit is upper threshold that triggers an Medium 220 Systolic High Limit alarm. The High Limit is upper threshold that triggers an Medium 110 Diastolic High Limit alarm. Low Limit is the lower threshold that triggers an Medium 35 Diastolic Low Limit alarm. 42-259 in steps of 1, or Off When set to Off, alarm is disabled 22-199 in steps of 1, or Off When set to Off, alarm is disabled 21-198 in steps of 1, or Off When set to Off, alarm is disabled www.masimo.com 93 Masimo Root NIBPT Chapter 3: Operation From the Systolic/Diastolic screen, touch Trends, and then change any of the Factory Default Settings Configurable Options The NIBP Trend Max. The upper limit a measurement will be 260 The NIBP Trend Min. The lower limit a measurement will be 20 21-260 in steps of 1 20-259 in steps of 1 Trends for NIBP following options:

Options Description Y-Axis Max Y-Axis Min shown. shown. Pulse Rate (PR) following options:

From the Pulse Rate screen, touch Alarms, and then change any of the www.masimo.com 94 Masimo Root NIBPT Chapter 3: Operation Options Description Alarm Priority Factory Default Settings Configurable Options The High Limit is upper threshold that triggers an Medium 120 High Limit alarm. Low Limit is the lower threshold that triggers an Medium 50 Low Limit alarm. 40-215 in steps of 5, or Off When set to Off, alarm is disabled 35-210 in steps of 5, or Off When set to Off, alarm is disabled Mean Arterial Pressure (MAP) of the following options:

From the Mean Arterial Pressure screen, touch Alarms, and then change any www.masimo.com 95 Masimo Root NIBPT Chapter 3: Operation Options Description Alarm Priority Factory Default Settings Configurable Options The High Limit is upper threshold that triggers an Medium 120 High Limit alarm. Low Limit is the lower threshold that triggers an Medium 50 Low Limit alarm. 28-219 in steps of 1, or Off When set to Off, alarm is disabled 27-218 in steps of 1, or Off When set to Off, alarm is disabled Intervals for NIBP From the NIBP screen, select Intervals, then select a Set Mode: Automatic, Stat, or Schedule. See the table below for factory default and user configurable settings:

www.masimo.com 96 Masimo Root NIBPT Set Mode Description Configuration Default Configurable Chapter 3: Operation Factory User Settings Settings 2 min, 3 min, 4 min, 5 min, 10 min, 15 min, 30 min, 60 min, 90 min Automatic measurements Interval 15 min Automatic interval measurement mode will take blood pressure once every defined interval. See Set Mode: Automatic on page 155. Stat interval measurement mode will take blood pressure measurements continuously for the defined duration. See Set Mode: Stat on page 158. Stat Stat Duration 10 min 5 min, 10 min www.masimo.com 97 Masimo Root NIBPT Set Mode Description Configuration Default Configurable Chapter 3: Operation Factory User Settings Settings Interval and Duration settings can be customized to accommodate a facilities protocol. Note:

Schedule mode is configured in Root by authorized personnel. Up to five (5) uniquely defined Interval :

Duration pairs can be stored. Schedule once every defined NA Interval :

Duration Schedule measurement mode will take blood pressure measurements interval for the defined duration. See Set Mode:

Schedule on page 160. www.masimo.com 98 Masimo Root NIBPT Chapter 3: Operation Additional Settings for NIBP From the NIBP screen, touch Additional Settings, and then change the following option:

Options Description Factory User Default Configurable Settings Settings Measurement Timeout Defines the value of when the last BP reading values 15 min will clear the window. 5, 10, 15, 30, 60 and 90 minutes Calibration for NIBP The Calibration option on the NIBP menu allows a qualified service professional to access calibration settings and tools for the NIBP module. For more information, see NIBP Module Calibration Test on page 231. Note: This section is provided as a reference and intended for qualified service professionals only. Sounds www.masimo.com 99 Masimo Root NIBPT audio pause for Root. Use the Sounds screen to control the volume level of sounds and duration of Chapter 3: Operation Option Description Factory Configurable Settings Default Setting Alarm Sets the alarm volume Highest Volume level. Slide towards the left to decrease volume to volume silence. Pulse Tone Sets the pulse tone volume Volume level. Slide towards the left to 3 decrease volume to silence. www.masimo.com 100 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Configurable Settings Default Setting Sets the length of time that alarms when Audio Pause Audio Pause the audible alarm remains is enabled, but visual silenced, when Audio alarms will still display. 2 minutes Duration Pause is enabled. See Audio Pause on page 126. 1, 2, 3 minutes, Permanent*, Permanent with Reminder*. If Permanent is selected, there will be no audible If Permanent with Reminder is selected, a tone will sound every three (3) minutes as a reminder that Permanent is active when Audio Pause is enabled. SmartTone Off On or Off Allows the audible pulse to continue to beep when the pleth graph shows signs of motion.

*Requires the all mute enabled option to be toggled to ON in the Access Control menu. See Access Control on page 111. www.masimo.com 101 Masimo Chapter 3: Operation The Device Settings menu allows the user to view and customize settings for Root NIBPT Device Settings Root. The Device Settings options are:

Localization See Localization on page 103. See Kite on page 104 See Wi-Fi on page 105. Kite Wi-Fi Ethernet Bluetooth See Ethernet on page 107. See Bluetooth on page 108. Root Battery See Root Battery on page 109. www.masimo.com 102 Masimo Root NIBPT Chapter 3: Operation Radical-7 Battery See Radical-7 and Radius-7 Battery on page 110. Brightness See Brightness on page 110. Access Control See Access Control on page 111. Device Output See Device Output on page 116. Localization Use the Localization screen to view the current date and time and configure settings related to local time, language and geography. The user can also access the Localization screen by pressing the current time on the Status Bar. See About the Status Bar on page 53. www.masimo.com 103 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Default Setting Selects the language display Language for Root. English available Date Sets the display format for Format current date. mm/dd/yy Time Sets the display format for Format current time. 12 hour Configurable Settings Choose from languages. mm/dd/yy or dd/mm/yy 12 hour or 24 hour Line Sets to match regional Frequency power line frequency. 60 Hz 50 Hz or 60 Hz Date Sets the current date. N/A Time Sets the current time. N/A N/A N/A www.masimo.com 104 Masimo Root NIBPT Chapter 3: Operation Use the Kite screen to enable or disable Kite connectivity. Option Description Factory Configurable Enable Kite Activates or deactivates an Connection active Kite connection. Default Settings Setting enabled(no key) disabled enabled (key) or disabled Four (4) digit code Automatic with Pairing Key automatically assigned for N/A active Kite active Kite session. connection The Wi-Fi radio allows for networked communication of data and alarm signals between Root and a secondary patient monitoring station, Masimos Patient SafetyNet over an IEEE 802.11 a/b/g wireless network. The wireless data transmission is an optional network data transmission to the wired network data transmission, using Roots integral Ethernet Port. www.masimo.com 105 Masimo Kite Wi-Fi Root NIBPT Chapter 3: Operation Root uses only configured MAC addresses to establish wireless communications to prevent unauthorized connections to other wireless devices. As risk mitigation to the loss of the wireless communication, Roots alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Roots primary alarms. Use the Wi-Fi screen to enable or disable Wi-Fi connectivity. When Root is connected to a Wi-Fi network, the Wi-Fi icon on the Status Bar conveys the strength of the connection. See About the Status Bar on page 53. Option Description Factory Default Setting Configurable Settings Enables or disables Wi-Fi Wi-Fi connectivity. Off On or Off Additional fields in the Wi-Fi screen display read-only settings about the Wi-Fi connection that cannot be configured by the user. Your Masimo sales representative can provide necessary information regarding an initial Wi-Fi connection. For more information, see the Patient SafetyNet Operator's Manual. CAUTION: Unanticipated failure or alteration of network components

(including but not limited to: disconnection or malfunctioning of a networking device/switch/router/ethernet cable) may result in loss of connectivity of Kite to other hospital systems. Altering or making changes to the hospital network should be done with proper knowledge. www.masimo.com 106 Masimo Root NIBPT Chapter 3: Operation Connecting Root to Patient SafetyNet Root can be configured to connect to Patient SafetyNet wirelessly by authorized and trained personnel only. The wireless icon in the Status Bar on Root displays the current connection status. See About the Main Screen on page 52. A gray icon indicates Root wireless radio is on, but it is not connected to a wireless network. A blue icon indicates Root is connected to a wireless network, but not communicating with Patient SafetyNet. A green icon indicates Root is connected to a wireless network and communicating directly with Patient SafetyNet. Icon Description Ethernet Use the Ethernet screen to enable or disable Ethernet connectivity. When Ethernet connectivity is enabled, the Ethernet icon will appear in the Status Bar. See About the Status Bar on page 53. www.masimo.com 107 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Default Configurable Setting Settings Ethernet Enables or disables Ethernet connectivity. On On or Off Additional fields in the Ethernet screen display read-only settings about the Ethernet connectivity that cannot be configured by the user. Bluetooth The Bluetooth radio allows for the detection of the close proximity of Masimos MyView Presence Tag. Roots detection of Masimos MyView Presence Tag is an optional feature that allows for the display of predetermined customized settings by a clinician. Root utilizes only configured MAC addresses to establish Bluetooth communication to prevent unauthorized connection to other Bluetooth enabled devices. Use the Bluetooth screen to enable or disable Bluetooth connectivity. When Bluetooth connectivity is enabled, the Bluetooth icon will appear in the Status Bar. See About the Status Bar on page 53. www.masimo.com 108 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Enables or disables Bluetooth Bluetooth connectivity. Off On or Off For more information on how to configure MyView Presence Tag, see the Patient SafetyNet Operator's Manual. Root Battery Use the Root Battery screen to view the specific percentage of charge on the battery. The user can also access Root's Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 53. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Allows trained personnel to access battery diagnostic Diagnostics information. www.masimo.com 109 Masimo Root NIBPT Chapter 3: Operation Radical-7 and Radius-7 Battery Use the Battery screen to view the specific percentage of charge on the Radical-7 or Radius-7's battery. For Radical-7, the user can also access the Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 53. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Allows trained personnel to access battery diagnostic Diagnostics information. Brightness Use the Brightness screen to adjust the brightness of the Root display. www.masimo.com 110 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Allows automatic adjustment of Auto Brightness ambient light. Root's display brightness based on Off On or Off Adjust the brightness level of the Brightness Root display by sliding the button (4 4 1, 2, 3, 4 is brightest). Access Control password. To enter Access Control Access Control contains configurable options and settings that require a www.masimo.com 111 Masimo Root NIBPT 1. Press the key. Chapter 3: Operation 2. When the numeric screen displays, enter the following numbers: 6 2 7 4 Asterisks (****) will be displayed. To undo an entry, press Backspace. 3. Press Enter to access the password protected screen. Note: The password will have to be entered every time this screen is accessed. Option Description Factory Configurable Power On Profile Sets the profile used when the device is powered on. Previous Profile Default Settings Setting Adult, Adult Modified, Neonatal, Pediatric, or Previous Profile www.masimo.com 112 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Configurable Default Settings Setting All Mute Enabled Enables or disables parameter Alarm See Sounds on page 99. Silence menu option. Off On or Off Lock Alarm Sets the lowest alarm Volume volume level. Off 3, 4, or Off Optical Enables or disables Sensor Off alarm delay when 0 Sec. Alarm Delay Optical Sensor is off. 0, 5, 10, 15, 30, or 60 seconds Enables or disables Standby option for Standby Enabled Mode. See Standby Mode on page 128. Off On or Off Standby Reminder Tone Interval Allows for time interval 30 sec, 1 min, 2 of 30 sec, 1 min, 2 min, min, 3 min, 5 30 sec 3 min, 5 min, 10 min, or min, 10 min, 15 15 min, as well as Off. min, or Off Allow Allows for Root Unsigned software to be reverted Off On or Off Upgrade back to older version www.masimo.com 113 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Sessions Enabled Enables or disables Session Management. Management on page 129 See Session Off On or Off Enables option to change baud rate of 921600 USB Port 1*

baud rate device Enables option to change baud rate of 921600 USB Port 2*

baud rate device 9600, 19200, 38400, 57600, 115200, 230400, or 921600 9600, 19200, 38400, 57600, 115200, 230400, or 921600 Data Enables or disables Collection physical data collection Off On or Off Enabled mode. Enables or disables EDF EDF data collection Enabled Operator's Manual for SedLine) Collection from SedLine (See Off On or Off www.masimo.com 114 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Synchronized Enables or disables Waveforms Synchronization Off On or Off Enabled Waveform view. Presence Enables or disables Monitoring Presence Monitoring Off On or Off Saves current profile Press Save to Save as Adult parameter as the Adult N/A update the Profile. profile. Save as Pediatric Saves current profile Press Save to parameter as the N/A update the Pediatric Profile. profile. Saves current profile Press Save to Save as Neo parameter as the N/A update the Neonatal Profile. profile. Factory Options are restored to Defaults factory value. N/A Press Restore.

*Changes to USB Ports baud rate will take effect after Root is power cycled, turned off then on again. Note: Restore Factory Defaults can only be performed during non-monitoring and no cable connections are present. www.masimo.com 115 Masimo Chapter 3: Operation Root NIBPT Device Output The Device Output screen allows the user to configure additional data output options. A Nurse Call can be triggered based on alarm, low Signal IQ events or both. In addition, Nurse Call Polarity can be inverted to accommodate local Nurse Call station requirements. Option Description Factory Configurable Default Settings Setting Nurse Call Trigger Controls the source of monitoring which sets off Alarms the trigger. Alarms, Low SIQ, Alarms + SIQ Nurse Call occur. Should be changed Polarity to accommodate Normal Normal or Inverted Controls the mechanism of action for triggering to institutional Nurse Call settings. Controls the output type for USB Port 1 USB Port 1. None, SatShare, None ASCII 1, IntelliBridge, or IAP www.masimo.com 116 Masimo Root NIBPT Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Controls the output type for USB Port 2 USB Port 2. None, SatShare, IAP ASCII 1, IntelliBridge, or IAP IntelliBridge Output Options*

Controls the data type output for IntelliBridge. Radical Radical Radical Module A SedLine Numerics only SedLine, O3 Sensor 1/2/L/R Capnography SedLine, O3 Sensor 1/2/3/4

*Displays when IntelliBridge is selected as USB Port Output. Note: The Nurse Call feature is disabled when Audio Pause is enabled and Nurse Call Trigger is set to Alarms. For more information about Audio Pause, see Audio Pause on page 126. IntelliBridge Connectivity IntelliBridge connectivity allows Root to transmit parameters and waveforms to Philips multi-parameter patient monitors that support Philips IntelliBridge device interfacing modules. This option allows parameters and waveforms on www.masimo.com 117 Masimo Root NIBPT Chapter 3: Operation Root to be displayed on a Philips monitor and, if applicable, transmitted to the electronic medical record system. Masimo parameters from SET, rainbow SET, and SedLine, channels are supported. manufacturer. Masimo waveforms from SET, rainbow SET, channels are supported. Note: Root supports the transmission of data only. Validations of the retrieval and display of data transmitted is the responsibility of the IntelliBridge www.masimo.com 118 Masimo Root NIBPT Chapter 3: Operation Parameters Supported IntelliBridge connectivity allows for up to six (6) parameters and two (2) waveforms or eight (8) parameters and no waveform to be displayed on Philips monitors. Channel Supported Parameters Waveforms SET SpO2, PR, Pi, PVi Pleth rainbow RRa, SpHb, SpCO, SpOC, SpMet RRa SedLine PSi, SR, EMG, ARTF, SEFR, SEFL N/A etCO2, FiCO2, RR, etN2O, FiN2O, EtO2, Capnography FiO2, EtENF, FiENF, EtDES, FiDES, EtHAL, FiHAL, EtISO, FiISO, EtSEV, FiSEV, MAC CO2, uom %, CO2 uom kPa, CO2, uom mmHg, O2, AA1 Use the About screen to view the serial number as well as software and hardware version information about Root. These details may be helpful during troubleshooting. www.masimo.com 119 Masimo About Root NIBPT Chapter 3: Operation Option Description Serial Number Displays the serial number for the device. MCU 1 Displays software version number. Processor Displays processor version number. MCU 2 Displays software version number. MIB Displays MOC-9 interface revision. Information about Radical-7, Radius-7, and MOC-9 modules will display in a separate list. These fields are read-only and cannot be configured by the user. Trend Settings Use the Trend Settings screen to configure trend viewing on the Main Screen and trend data storage on Root. Option Description Configurable Settings Factory Default Setting Default Duration captured by Duration Trend Graph. 15, 30, and 45 minutes 2 hours 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours www.masimo.com 120 Masimo Root NIBPT Chapter 3: Operation Option Description Configurable Settings Clear Delete all stored Press Clear to delete all Trends trend data. stored trend data. To configure trend settings for specific parameters and measurements, see Directions for Use or Operator's Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s). Factory Default Setting N/A Use the Profiles screen to select patient type. Option Description Factory Default Setting Configurable Settings Profile Name Identifies the Profiles setting in the device. Adult Adult, Pediatric, Neonatal, Custom Configure Identifies the patient Profile category type. Adult Adult, Pediatric, Neonatal Root can be configured for various patient types by using the Profiles feature. Profile selection controls the management of patient configuration www.masimo.com 121 Masimo Profiles Root NIBPT Chapter 3: Operation settings on Root. The settings of the three default profiles (Adult, Pediatric, and Neonatal) configure parameter alarms, averaging time, and sensitivity Root has the ability to support up to eight (8) custom profiles to accommodate usage in any hospital environment. For more information regarding Profiles, see the Instructions for Use or Operators Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s). The status of the four (4) Iris Connectivity Ports as well as the connection type

(for example, monitor, pump, ventilator) will be displayed on the Iris Status screen. See Iris Screen on page 187. modes. Iris www.masimo.com 122 Masimo Root NIBPT Chapter 3: Operation Alarms can have different priority levels and come from different sources. The following tables describe alarm behaviors in more detail. Alarm Interface Priority Alarm Sound High 10-pulse burst Medium 3-pulse burst Alarm Source Parameter Level Example Explanation The example shown here is a PR alarm as the reading (61) exceeds the lower alarm limit (65). Note: The borders of both the PR Trend Display as well as the Window are illuminated red, and the explanation of the alarm is shown at the top of the Window

(PR Low < 65). www.masimo.com 123 Masimo Example Explanation Root NIBPT Alarm Source Window Level System Level Chapter 3: Operation The example shown here is a

"High Impedance" alarm in the lower Window. Note: The border of the Window illuminates red, and the explanation of the alarm is shown at the top of the Window (High Impedance Detected). The example shown here is a "Low Battery" alarm. Note: The border of the entire Root display is illuminated yellow, and the explanation of the alarm is shown in the Status Bar (Low Battery). www.masimo.com 124 Masimo Root NIBPT Chapter 3: Operation For more details about specific alarms on Radical-7, Radius-7, and MOC-9 modules, see Directions for Use or Operators Manuals for Radical-7, Radius-7, and MOC-9 modules. Alarm Silence The Alarm Silence icon is an indicator as well as a functional button. It always indicates the presence of alarms, and it can be used to temporarily suspend audible alarms for a pre-configured amount of time, known as Silence Duration. Silence Duration configurations vary across different parameters and measurements. For more information about Silence Duration, refer to the instructions for use or Operators Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s). Icon Appearance Description There are currently no active alarms, and no alarms have been silenced. There are currently no active alarms, but at least one alarm has been and is still silenced. There is currently at least one active alarm that has not been silenced. There is currently at least one active alarm, but all active alarms are silenced. Visual Alarms No No Yes Yes www.masimo.com 125 Masimo Root NIBPT Chapter 3: Operation www.masimo.com 126 Masimo Root NIBPT Audio Pause Chapter 3: Operation Audio Pause temporarily suspends all audible alarms on Root. When it is active, visual alarms are not impacted and will still display. The Audio Pause icon is located on the left side of the Status Bar do not confuse with the Sounds icon on the right side of the Status Bar. See About the Status Bar on page 53. By default, Audio Pause is inactive, and the icon appears in the following way:

Audio Pause inactive To activate Audio Pause, press the icon. It will turn red and the remaining Audio Pause Duration time counts down next to the icon. The default duration for Audio Pause is 120 seconds. In the example below, Audio Pause is activated, and there are 15 seconds left until Audio Pause is inactive again. To configure Audio Pause, see Sounds on page 99. Audio Pause active. 15 seconds until Audio Pause is inactive. Note: When Audio Pause is activated, powering off and then powering on Root will return Audio Pause to its default inactive state. www.masimo.com 127 Masimo Root NIBPT Standby Mode Chapter 3: Operation Standby Mode allows for patient monitoring to be temporarily suspended. The Standby icon (see image below) is located in the top-left corner of the screen. To enable Standby Mode (suspend monitoring) 1. On Root, open the Access Control menu. 2. Swipe the standby enabled button to ON. Return to the home screen on Root, and the Standby icon will appear on the screen in the top-left corner. 3. Press the Standby icon, and a notification message will appear on the screen indicating that monitoring is suspended (see image below). To exit Standby Mode (resume monitoring) Tap anywhere on the screen. WARNING: When Root is in Standby Mode, monitoring is suspended and no alarms will be active, with the exception of the low battery alarm. Note: Standby Mode will not affect any devices using Root's Iris Connectivity to Masimo Patient SafetyNet. www.masimo.com 128 Masimo Root NIBPT Chapter 3: Operation Trend Download Root can store up to 96 hours of trend data captured at 2-second intervals from Radical-7, Radius-7, and MOC-9 modules. Trend data from Root can be transferred to a computer via USB for evaluation. Trend data is stored in non-volatile memory, so it is not erased when Root is shut off. Trend data download is initiated using the Masimo Instrument Configuration Tool, which converts the data to a .TXT or .CSV file. www.masimo.com 129 Masimo Root NIBPT Session Management Chapter 3: Operation Session Management, when enabled, allows clinicians to input a label (session name) which will output with data downloaded from Root. Enabling Session Management To enable session management go to Devices Settings. Choose Access Control then slide the Sessions Enabled button to the on position. Starting Session Management Press the session management icon on the Action Bar. Session Name window will open in which you can label the session. When data is downloaded from Root it can be identified by the label assigned to a particular session. See About the Action Bar on page 57. Note: When Session Management is enabled multiple sessions can be recorded, not simultaneously but sequentially. Ending Session Management To end a session, go to the Action Bar, press the session management icon with the timer overlay

. End Session window will open. Push the End button to end the session. Note: The maximum time for a session is 96 hours. www.masimo.com 130 Masimo Root NIBPT Chapter 3: Operation Screen Capture Up to 20 screen capture images can be stored in Root and transferred to a USB drive as PNG files. When the limit of 20 screen captures is reached in Root, every new screen capture will replace the oldest dated screen capture. Note: There must be a folder titled screen_shot in the USB drive with a FAT or FAT32 system file to enable the download of the screenshots. Capturing Screens To capture a screen:

www.masimo.com 131 Masimo Root NIBPT Chapter 3: Operation Swipe across the Root screen from right to left using two or more fingers simultaneously (see image below). www.masimo.com 132 Masimo Root NIBPT Chapter 3: Operation A confirmation flash will appear on the screen indicating a capture is in progress. A status message [1] will be displayed briefly at the top of the screen and the patient label name will be masked with asterisks [2]. www.masimo.com 133 Masimo Root NIBPT Chapter 3: Operation Reference Example Description The screen capture status message displays the following information:

Date: Date of screen capture (YYYYMMDD) Time: Time of screen capture (HHMMSS) Device Serial Number:

10 digit Root serial number Number of Screen Captures: The number of screen captures saved on Root of 20 screen capture limit. When the limit of 20 screen captures is reached, every new screen capture will replace the oldest dated screen capture. The patient label is masked with asterisks when capturing a screen. 1 2 www.masimo.com 134 Masimo Root NIBPT Chapter 3: Operation Downloading Screen Captures To download screen captures:

1. Remove any sensors connected to the patient to stop monitoring, and acknowledge any alarms triggered on Root. Note: Before connecting the USB drive in the next step, there must be a folder titled screen_shot in the USB drive with a FAT or FAT32 system file to enable the download of the screen captures. 2. Plug the USB drive into the USB port located on the rear panel of Root; the screen captures will automatically download. A status message will display briefly at the top of the Root screen to indicate the start of the download. 3. A confirmation status message will display briefly at the top of the Root screen when the file transfer is complete. 4. Unplug the USB drive from Root. To import the screen captures from the USB drive onto a computer, plug the USB drive into the computers USB port, then open the folder titled screen_shot (from the USB drive) on the computer to access the .png files. Lights System Status Lights The System Status Lights provide visual indications of alarms and system messages. The lights will illuminate in different colors depending on the state of the device. To locate the System Status Lights, see Side Views on page 36. www.masimo.com 135 Masimo Root NIBPT Chapter 3: Operation System Status Light Light Status Alarm Priority Indication None None Monitoring has not started. Green None There is currently no active alarms. Flashing Yellow Medium There is an active alarm of medium priority. Flashing Red High There is an active alarm of high priority. The alarm priority is determined by the Radical-7, Radius-7, and MOC-9 module(s) that are connected to Root. The following are system level alarm messages that accompany System Status Lights when Radical-7, Radius-7, and MOC-9 modules are not connected:

Status Light Message Alarm Priority Low battery Medium Service required High AC Power Indicator illuminates. Whenever Root is connected to an AC power source, the AC power indicator www.masimo.com 136 Masimo Root NIBPT Light Status Indication Chapter 3: Operation Green Root is connected to an AC power source. Off Root is not connected to an AC power source. Whenever Root is connected to an AC power source, if not fully charged, its Root Charging Indicator battery will charge. Light Status Battery Indication Green Battery is fully charged. Orange Battery is charging. Red Battery charging error. Battery is not being charged. Root is not connected to AC power Off source. Radical-7 and Radius-7 Charging Indicator www.masimo.com 137 Masimo Root NIBPT Chapter 3: Operation When Root is connected to an AC power source, it is able to charge a correctly docked Radical-7 or Radius-7. This is true whether the device is powered on, in Sleep Mode, or powered off. Conversely, when Root is not connected to AC power, it will not charge the device. The light status provides a visual indication of the battery condition:

Light Status Battery Indication Green Battery is fully charged. Orange Battery is charging. Red Battery is unable to charge. Off Battery is fully charged, not being charged. www.masimo.com 138 Masimo Root NIBPT Chapter 3: Operation To put Root in the Sleep Mode or Power Off Mode, follow these steps:

Sleep and Power Off State Description audible tone sounds. Sleep Mode sequence. Press and hold the Power Button for two (2) seconds until one (1) Sleep Mode conserves power while enabling a quicker startup Press and hold the Power Button for eight (8) seconds, until two (2) audible tones sound. The Home Button will flash, and the Power Power Off Mode Button will flash orange. Power Off Mode completely shuts down Root and results in a longer startup sequence. www.masimo.com 139 Masimo Chapter 4: Temperature Measurement Note: This feature is optional on Root. For temperature measurements obtained with the TIR-1 bluetooth thermometer, refer to the TIR-1 manual. Root offers an optional integrated temperature module and takes a temperature measurement through the use of a temperature probe. The temperature probe is designed for use on adult and pediatric patients. Patient temperature can be measured via an oral/axillary or rectal probe. Operation - Temperature Spot Check Mode Spot Check mode provides a one-time predictive measurement that takes a temperature in approximately 6 to 15 seconds, before a steady state temperature is achieved. Predictive measurements reduce the time required for measurement by using algorithms to predict what the temperature would be if the probe were left in place until steady state is achieved. Continuous Mode Continuous mode provides continuous temperature readings for up to 10 minutes through a direct measurement. Direct measurement is used to continuously read temperatures until it reaches the thermal steady state

(unchanging). The thermal steady state is achieved through an oral or rectal measurement in approximately 3 minutes and through an axillary measurement in approximately 5 minutes. www.masimo.com 141 Masimo Root NIBPT Chapter 4: Temperature Measurement Taking Temperature Measurement 1. Ensure that the correct measurement site is selected before measurement. Note: If a rectal probe is attached, the Site button will not appear. Note: The site selection toggle is disabled once the probe has been placed on the site. The toggle will be re-enabled once the probe has been returned to the probe well holder. 2. To change the measurement site, touch the Main Menu icon

, then select Temperature Settings

. Select Additional Settings

, then select the desired measurement site through Probe Mode. The measurement site can also be changed using the action menu. www.masimo.com 142 Masimo Root NIBPT Chapter 4: Temperature Measurement 3. Remove the temperature probe from the probe well holder to initiate spot check. Note: Ready status will display in the status bar and sound will play. 4. Apply a single-use disposable probe cover to the temperature probe before measurement. WARNING: The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. 5. Place the temperature probe on the site to begin spot check. WARNING: Before use, verify the color of the probe cover eject button on the temperature probe to confirm the proper application site: Red (rectal), Blue (oral/axillary). Note: Measuring status displayed in the status bar. www.masimo.com 143 Masimo Root NIBPT Chapter 4: Temperature Measurement 6. Wait for measurement to complete or return the probe to stop measurement. Note: If a reliable spot check measurement cannot be made, the temperature module will automatically switch to continuous mode to make the measurement. Note: Once measurement is successfully completed, value is displayed. If continuous monitoring is not needed, dock the temperature probe in the probe well holder to reset measurement. 7. To continuously monitor temperature, touch the action menu

, and then select Continuous mode

. Note: Continuous mode can only be enabled if the probe has not been removed from the measurement site during spot check. Note: Continuous mode provides continuous temperature readings for up to 10 minutes through a direct measurement. Note: Another spot check cannot be performed until the probe is first returned to the probe well holder. 8. Dock the temperature probe in the probe well holder to end temperature monitoring. www.masimo.com 144 Masimo Root NIBPT Chapter 4: Temperature Measurement Temperature Probes Two types of probes are available for use with the Root: an oral/axillary probe and a rectal probe. Root will automatically detect the probe type when connected: oral/axillary or rectal. Adult axillary Spot Check Mode (predictive) temperatures are measured using the oral/axillary probe in combination with the Root in Adult axillary mode. A temperature reading is provided in approximately 12-15 seconds. Pediatric axillary Spot Check Mode (predictive) temperatures are measured using oral/axillary probes in combination with the Root in Pediatric axillary mode. A temperature reading is provided in approximately 10-13 seconds. For oral temperatures, place the probe tip under the patient's tongue on either side of the mouth to reach the sublingual pocket and ask the patient to close his/her lips. Sublingual Pocket Location For axillary temperatures, lift the patient's arm so that the entire axilla is easily seen and place the probe as high as www.masimo.com 145 Masimo Root NIBPT Chapter 4: Temperature Measurement possible in the axilla. Do not allow the probe tip to come into contact with the patient until the probe is placed in the measurement site. Any prior contact between the probe tip and the tissue with another material may cause inaccurate readings. Verify that axillary tissue completely surrounds the probe tip and place the arm snugly at the patient's side. Firmly hold the probe in place and keep the tip of the probe in contact with the tissue throughout the measurement process. Remove the probe after the temperature measurement is complete and firmly press the ejection button on the top of the probe to release the probe cover. Return the probe to the probe well. Rectal temperatures are measured using rectal probes which give a Spot Check Mode (predictive) temperature in approximately 10-13 seconds. For rectal temperatures, separate the patient's buttocks with one hand. Use the other hand to gently insert the probe only 5/8 in. (1.5 cm) inside the rectum (less for infants and children). The use of a lubricant is optional. Tilt the probe so that the tip is in contact with tissue. Continue to separate the buttocks and hold the probe in place throughout the measurement process. Remove the probe after the temperature measurement is complete and firmly press the ejection button on the top of the probe to release the probe cover. Return the probe to the probe well and wash your hands. Regularly wipe the probe with a cloth dampened with warm water and a mild detergent solution, a 70% isopropyl alcohol solution, or a 10% chlorine bleach solution. www.masimo.com 146 Masimo Root NIBPT Chapter 4: Temperature Measurement Supported Masimo Probes and Probe Covers For a list of compatible temperature probes and accessories, visit http://www.masimo.com/. www.masimo.com 147 Masimo Chapter 5: NIBP Measurement Root provides noninvasive blood pressure readings through an oscillometric method. An oscillometric method of blood pressure measurement is a noninvasive method that monitors the amplitude of cuff pressure changes during cuff deflation to determine arterial blood pressure. The NIBP module is designed for use on adult, pediatric, and neonatal patients. Patient Measurement Mode Below is a table that provides a method for selecting the appropriate NIBP patient category. To change patient category see Profiles on page 121. Weight Patient Category Maximum Pressure Greater than 75lbs (34kg) Adult 280 mmHg Between 15.4-75lbs (7-34kg) Pediatric 280 mmHg Less than 15.4lbs (7kg) Neonatal 140 mmHg Cuff Selection and Placement Root uses a bayonet hose with a blood pressure cuff to measure NIBP. For a list of compatible NIBP patient hoses and cuffs, visit http://www.masimo.com/. To ensure the correct cuff size Wrap the cuff around the arm. www.masimo.com 149 Masimo Root NIBPT Chapter 5: NIBP Measurement The index line should align within the cuff range markings If the index line does not fit within the range markings, select a larger or smaller cuff. www.masimo.com 150 Masimo

. Root NIBPT Chapter 5: NIBP Measurement To place cuff on the measurement site Wrap the cuff around the non-dominant arm, making sure that the Artery Marker is aligned over the brachial artery as shown in the image below. To locate the brachial artery, place the pads of your index and middle fingers halfway between the shoulder and elbow, in the middle of the inner arm, between the bicep and triceps muscles. If possible, do not wrap the cuff over the patients clothing. The cuff should fit snugly around the patients arm for maximum oscillometric signal quality. The lower edge of the cuff should be located 2 cm above the antecubital fossa (interior bend of the elbow). Ensure that the air hose from the monitor to the cuff is not compressed, crimped, or damaged. Patient Conditions When measuring the patient's blood pressure, it is recommended that the patient be in Normal Use position. Ensure that the following conditions are met before taking the patient's blood pressure:

www.masimo.com 151 Masimo Root NIBPT Chapter 5: NIBP Measurement Patient is comfortably seated Patient's legs are uncrossed Patient's feet are flat on the floor Patient's back and arm are supported The middle of the cuff is at the level of the right atrium of the heart Blood pressure measurements can be affected by the patient's position, physiological condition, and environmental factors. Physiological conditions that can affect blood pressure measurements include, but are not limited to, cardiac arrhythmias, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, trembling, or Note: It is recommended to notify the patient to relax and not talk during the Note: It is recommended that 5 minutes should elapse before the first reading shivering. measurement. is taken. Operation - NIBP Root works by noninvasively monitoring the amplitude of cuff pressure changes during cuff deflation to determine arterial blood pressure. The cuff pressure is first elevated above the patient systolic blood pressure level. The cuff will then begin to deflate at a certain rate. The initial rise in the amplitude of pressure fluctuations during cuff deflation corresponds closely to the systolic blood pressure. As the cuff is further deflated, the pressure fluctuations increase in amplitude until a peak is reached which is usually referred to as the mean arterial pressure (MAP). As cuff deflation continues, www.masimo.com 152 Masimo Root NIBPT Chapter 5: NIBP Measurement the diastolic pressure can be determined based upon the rapidly diminishing amplitude of the pressure fluctuations. Spot Check Measurement To spot check measure NIBP 1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. Note: The Patient Category determines the initial inflation pressure of NIBP. Ensure that the proper patient profile and subsequent patient category are appropriate for the intended patient to be 2. To change the patient profile, press the Main Menu icon

, then measured. select Profiles

. Press the Profile Name to select the desired patient profile. www.masimo.com 153 Masimo Root NIBPT Chapter 5: NIBP Measurement 3. Properly place the blood pressure cuff on patient. See Cuff Selection and Placement on page 149. 4. Press the Start button to begin measurement. 5. Wait for measurement to complete or press the Stop button to stop measurement. Note: Measuring status displayed in the status bar. www.masimo.com 154 Masimo Root NIBPT Chapter 5: NIBP Measurement 6. Wait for measurement values to appear to ensure that spot check is complete. www.masimo.com 155 Masimo Root NIBPT Chapter 5: NIBP Measurement Set Mode: Automatic Automatic interval measurement mode will take blood pressure measurements once every desired interval. To measure blood pressure in Automatic interval mode 1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. 2. To change the patient profile, press the Main Menu icon

, then select Profiles

. Press the Profile Name to select the desired patient profile. 3. Properly place the blood pressure cuff on patient. See Cuff Selection and Placement on page 149. www.masimo.com 156 Masimo Root NIBPT Chapter 5: NIBP Measurement 4. To enable Automatic mode, press the Main Menu icon

, then select NIBP Settings

. On the Intervals screen, change Set Mode to Automatic, and then select the desired Interval. The set mode can also be changed using the action menu. WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. 5. To begin measurement, press the Start Auto button and then press the arrow at the top-left corner of the touchscreen to return to the Main View. the measurement. 6. Wait for measurement to complete or press the Stop button to stop www.masimo.com 157 Masimo Root NIBPT Chapter 5: NIBP Measurement Note: Once finished measuring, values will appear and the next measurement will begin after the specified interval. Set Mode: Stat Stat interval measurement mode will take blood pressure measurements continuously for the desired duration. To measure blood pressure in Stat interval mode 1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. 2. To change the patient profile, press the Main Menu icon

, then select Profiles

. www.masimo.com 158 Masimo Root NIBPT Chapter 5: NIBP Measurement Press the Profile Name to select the desired patient profile. 3. Properly place the blood pressure cuff on patient. See Cuff Selection and Placement on page 149. 4. To enable Stat mode, press the Main Menu icon

, then select NIBP Settings

. the action menu. On the Intervals screen, change Set Mode to Stat, and then select the desired Stat Duration. The set mode can also be changed using WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. www.masimo.com 159 Masimo Root NIBPT Chapter 5: NIBP Measurement 5. To begin measurement, press the Start Stat button and then press the arrow at the top-left corner of the touchscreen to return to the 6. Wait for measurement to complete or press the Stop button to stop Main View. the measurement. Note: Once measurement is completed and values appear, the next measurement will begin and repeat until duration time has elapsed. Set Mode: Schedule Schedule* interval measurement mode will take blood pressure measurements once every defined interval for the defined duration. A patient profile can have up to five (5) schedules. The schedules will run consecutively, when one schedule ends the next one will begin automatically. www.masimo.com 160 Masimo Root NIBPT Chapter 5: NIBP Measurement

*Schedules are configured by authorized personnel. To measure blood pressure in Schedule mode:

1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. 2. To change the patient profile, press the Main Menu icon

, then select Profiles

. 3. Press the Profile Name to select the desired patient profile. 4. Properly place the blood pressure cuff on the patient. See Cuff Selection and Placement on page 149. 5. To enable Schedule mode, press the Main Menu icon

, then select NIBP Settings

. 6. On the Intervals screen, change Set Mode to Schedule. The set mode can also be changed using the action menu. www.masimo.com 161 Masimo Root NIBPT Chapter 5: NIBP Measurement WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. 7. Press the Start Schedule button. 8. Press the arrow at the top-left corner of the touchscreen to return to the Main View. 9. Wait for the interval measurement to complete or press the Stop button to stop the interval measurement. www.masimo.com 162 Masimo Root NIBPT Chapter 5: NIBP Measurement After an interval measurement has completed and values appear, the next interval measurement will begin and repeat until the duration time has elapsed. www.masimo.com 163 Masimo Chapter 6: Admit and Discharge to Patient SafetyNet The Admit/Discharge icon is located at the bottom left of the Main Screen and allows for clinicians to admit or discharge patient's on Masimo Patient SafetyNet directly from Root. Note: In order to use this feature Masimo Patient SafetyNet software version 5.0.1.0 or higher is required. www.masimo.com 165 Masimo Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Not Admitted A Not Admitted message will appear on the Root screen when the sensor is placed onto a patient and a patient has not yet been admitted on the Root. Press the Admit button on the screen to admit the patient or press skip and the patient data will not be transmitted to the Masimo Patient Safety Net. www.masimo.com 166 Masimo Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Admitting a Patient To admit a patient:

1. Press the admit icon on the bottom-left of the main screen. 2. Enter the authentication PIN. 3. Either press the patient info search button (1) to select existing patient information, or enter new patient information in the data 4. Press the assignments search button (3) and select the primary fields (2). and secondary pagers (4). www.masimo.com 167 Masimo Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet 5. Press the Admit button (5). Discharging a Patient To discharge a patient:

1. Press the discharge icon on the bottom-left of the main screen. 2. Enter the authentication PIN. www.masimo.com 168 Masimo Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet 3. Press the Discharge button. A confirmation message will appear. 4. Press the Discharge confirmation button. Note: Once patient is discharged from Root, or session is ended, the NIBP parameter display will be cleared. www.masimo.com 169 Masimo Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Not Monitoring Message When the sensor is off the patient for an extended period of time, a Not Monitoring message will appear on the screen. Acknowledge the message by pressing Cancel or Discharge. Press Discharge to discharge the patient that is currently admitted on the Root, or press Cancel to keep the same patient admitted. www.masimo.com 170 Masimo Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Monitoring Resumed Message When the sensor is taken off and placed back onto a patient, a Monitoring Resumed message will appear on the Root screen. If this is a new patient, press Discharge on the screen to discharge the previous patient. If the same patient is being monitored, press Confirm to continue monitoring the same patient. www.masimo.com 171 Masimo Chapter 7: Electronic Medical Record

(EMR) Push The Electronic Medical Record (EMR) Push feature allows clinicians to send validated patient vitals data from any of the Masimo devices, MOC-9 modules, or Iris devices connected to Root directly to a Patient Data Management System, such as an Electronic Medical Record (EMR). Determining EMR Push is Active The EMR Push icon appears at the bottom of the Root main screen when the EMR Push feature is active. The EMR Push feature is active when a Root patient profile is connected to a Patient SafetyNet server. If the EMR Push icon does not appear, see Masimo Technical Services on page 248. Note: The Patient SafetyNet server can be configured to require clinicians to provide access credentials to activate the EMR Push feature. To configure Patient SafetyNet to require access credentials, see Masimo Technical Services on page 248. Manually Entering Patient Data Follow the instructions below to manually enter patient data. Note: Parameters with manual entry permissions can be pre-configured on Patient SafetyNet. See Masimo Technical Services on page 248. www.masimo.com 173 Masimo Root NIBPT Chapter 7: Electronic Medical Record (EMR) Push 1. In the EMR Push screen, press a parameter that has a pencil icon

. 2. In the manual entry screen, move the slide knob or press the spinner to select the desired parameter value. 3. Press OK to accept the selected manual entry value, or press Cancel to delete the manual entry value and return to the EMR Push screen. After pressing OK, the selected manual entry value appears on the EMR Push screen. www.masimo.com 174 Masimo Root NIBPT Chapter 7: Electronic Medical Record (EMR) Push Sending Patient Data to the EMR Follow the instructions below to send patient data to a data management system using the EMR Push feature. Note: Parameters that appear on the EMR Push screen can be pre-configured on Patient SafetyNet. For questions about pre-configuring EMR Push parameters, see Masimo Technical Services on page 248. 1. Select the EMR Push icon at the bottom of the Root Main Screen. 3. Press OK. 2. In the Authentication screen, enter a username and PIN. Note: Username and PIN requirements are enabled through Patient SafetyNet. If unable to authenticate a username and PIN, see Masimo Technical Services on page 248. 4. In the EMR Push screen, review and manually enter patient data before submitting to the EMR. See Manually Entering Patient Data on page 173. 5. Press the Submit button to send patient data to the EMR or press the Back button to return to the Main Screen. 6. After pressing the Submit button, select to send patient data to the EMR. www.masimo.com 175 Masimo Root NIBPT Chapter 7: Electronic Medical Record (EMR) Push 7. Press OK in the Successfully Sent Data to EMR confirmation screen. www.masimo.com 176 Masimo Chapter 8: Radical-7 The Radical-7 is a detachable portable noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi), along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin

(SpMet), pleth variability index (PVi), and/or acoustic respiration rate (RRa). It can be docked to Root to transfer parameter data to Root. When Radical-7 is docked to Root, the device automatically creates a Window that displays all the data from Radical-7. Root also acts as a charging station for Radical-7. See Radical-7 Operator's Manual for more information. www.masimo.com 177 Masimo Chapter 9: Radius-7 The Radius-7 is a patient wearable device for continuous monitoring when the patient is ambulatory. It measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi) along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin

(SpCO), total oxygen content (SpOC), methemoglobin (SpMet), and/or acoustic respiration rate (RRa). It uses a Bluetooth connection to transfer parameter data to Root. When Radius-7 is connected to Root via Bluetooth, the device automatically creates a Window that displays all the data from Radius-7. more information. Root also acts as a charging station for Radius-7. Radius-7 is docked onto Root via a Battery Charging Adapter. See Radius-7 Operator's Manual for www.masimo.com 179 Masimo Chapter 10: MOC-9 Flexible measurement expansion is enabled through MOC-9. It can display parameters and measurements captured by SedLine, ISA Capnography, and third-party technologies in an all-in-one view on Root. When any MOC-9 module is connected, Root automatically creates a Window that displays all the data from that module. The example below shows the SedLine and Capnography Windows which display data from the SedLine brain function monitoring and ISA capnography MOC-9 modules that are connected to Root. For any MOC-9 device connected to Root, refer to the MOC-9 device's Operator's Manual/Directions for Use for all information. www.masimo.com 181 Masimo Root NIBPT Chapter 10: MOC-9 Use a MOC-9 cable to connect other MOC-9 modules to Root. Using MOC-9 Ports To use an MOC-9 Port 1. Identify the MOC-9 end of the cable. 2. Orient the cable to fit correctly into an MOC-9 Port. 3. Insert the MOC-9 cable securely into any of the three (3) compatible ports on Root. www.masimo.com 182 Masimo Chapter 11: Iris Iris allows a variety of standalone devices to connect to Root. Patient data can be passed through Root to Patient SafetyNet or Connectivity Gateway, which can send the data to electronic health records. Below is an example of one way Root can be used in a network setting using Patient SafetyNet. Root receives and may display information from Radical-7, MOC-9 modules, as well as standalone devices. www.masimo.com 183 Masimo Root NIBPT Chapter 11: Iris 1 Standalone devices connected via Iris (e.g., monitor, pump, ventilator) Ref. Description 2 Root 3 Patient SafetyNet View Station 4 Patient SafetyNet or Masimo Connectivity Gateway 5 Notification devices 6 Electronic Health Records system www.masimo.com 184 Masimo Root NIBPT Using Iris Connectivity Ports Chapter 11: Iris Use Iris Adapters and RJ-45 cables to connect standalone devices to Root. To connect a standalone device via an Iris Connectivity Port:

1. Connect the Iris Adapter to the standalone device. Refer to the Iris Adapter Directions for Use. 2. Connect the RJ-45 end of the Iris Adapter to any of the four (4) compatible Iris Connectivity Ports on Root using a RJ-45 cable. www.masimo.com 185 Masimo Root NIBPT Chapter 11: Iris Iris Icon The Iris icon located in the Status Bar indicates Iris port connectivity status. See About the Status Bar on page 53. The Iris ports are mapped to the Iris icon according to the diagram below:

Iris connectivity port status is indicated in the Iris icon by color and shape. See the table below for further description. Iris Port Connection Iris Icon Example Description of Status Description Connection Connected with solid Green border green square Standalone device is successfully connected to Root and Root is successfully connected to a Patient SafetyNet or Connectivity Gateway. Standalone device is connected to Iris adapter SafetyNet or Connectivity Gateway. Attempting/Unable to Connect to Server Yellow border in Root, but Root is with solid attempting or unable to yellow square connect to a Patient www.masimo.com 186 Masimo Root NIBPT Chapter 11: Iris Iris Port Connection Iris Icon Example Description of Status Description Connection Disconnected White border Root is not connected to No standalone device is connected to Root and a Patient SafetyNet or Connectivity Gateway. Note: Status and connection type are read-only and not configurable by the user. For more information about Iris connectivity, see the Operators Manual for the appropriate version of Masimo Patient SafetyNet. www.masimo.com 187 Masimo Root NIBPT Chapter 11: Iris The Iris Screen displays Iris port connectivity and standalone device Iris Screen information. To view the Iris Screen:

Press the Iris icon in the Status Bar. See About the Status Bar on page 53. The Iris Screen displays 4 Iris port connectivity tiles. Each Iris port connectivity tile displays the [1] Iris port connectivity indicator and [2] device type, model, and Iris port connectivity status. The Iris port connectivity status is indicated by color and displayed message. See the table below for further description. www.masimo.com 188 Masimo Root NIBPT Chapter 11: Iris Connectivity Connection Description of Connection Status Message Status Color Connected Green tile Standalone device is successfully border connected to Root, and Root is Green successfully connected to Patient indicator SafetyNet or Iris Gateway. Yellow tile Standalone device is connected to Iris Connecting to border adapter in Root, but Root is attempting Iris Server Yellow or unable to connect to Patient indicator SafetyNet or Iris Gateway. Disconnected Root, and Root is not connected to Patient SafetyNet or Iris Gateway. No standalone device is connected to No color tile border Gray indicator Note: Status and connection type are read-only and not configurable by the user. For more information about Iris connectivity, see the Operators Manual for the appropriate version of Masimo Patient SafetyNet. www.masimo.com 189 Masimo Chapter 12: Bluetooth Devices Flexible measurement expansion is possible through the Root Bluetooth connection. Root displays measurements captured by external device technologies in an all-in-one view on Root. When an external device is connected to Root via Bluetooth, Root automatically creates a window that displays all the data from that device on the Main Screen. Connect Device to Root Connect an external device to Root using Bluetooth 1. Ensure Bluetooth is enabled on Root. See Bluetooth on page 108. 2. Ensure Bluetooth is enabled on the external device; refer to the external device's Operator's Manual if needed. 3. On the Root main screen, touch the Main Menu icon. 4. Press the Device Settings icon. 5. Press the Bluetooth icon. 6. On the Bluetooth screen:

Press the Pair button for the desired external device. Select the desired external device under the Devices Found list. The external device is now paired with Root. Refer to the external device's Operator's Manual for proper operation. www.masimo.com 191 Masimo Chapter 13: Messages The following messages are specific to Root:

Message Explanation Next Step Battery Charge is Low. The internal battery needs to be charged. System Status Lights flash yellow. Charge Root's battery using AC power. MOC-9 module Disconnected

(e.g. SedLine Disconnected) Reconnect module or A MOC-9 module is acknowledge message by disconnected from Root. pressing the Alarm Silence Radical-7 Radical-7 is disconnected acknowledge message by Disconnected from Root. pressing the Alarm Silence Reconnect Radical-7 or Radius-7 Radius-7 is disconnected acknowledge message by Disconnected from Root. pressing the Alarm Silence Reconnect Radius-7 or icon. icon. icon. Check Probe Probe is not responsive. Check probe tip condition. Re-insert probe into probe well or check for alignment problem. If problem persists, replace the probe. If problem still persists, www.masimo.com 193 Masimo Root NIBPT Chapter 13: Messages Message Explanation Next Step contact Customer Service. An error has occurred in the Retake Measurement process of taking a patient Try another measurement temperature measurement cycle. If problem persists, with the optional integrated replace probe. temperature module. Check Ambient Ambient temperature may Temperature be too high or too low. specification. Verify ambient temperature does not exceed operating Check internal temperature at probe well. Probe is not responsive due Replace Probe to not being calibrated or Replace probe. damaged. Patient or environmental Temperature temperature conditions Out of Range may be too low for a temperature measurement. Verify patient temperature is not outside of the measurement range. Verify ambient temperature does not exceed operating specification. If conditions are valid and www.masimo.com 194 Masimo Root NIBPT Chapter 13: Messages Message Explanation Next Step problem persists, replace probe. If problem still persists, contact Customer Service. Power cycle the device. If problem still persists, contact Customer Service. Module Error error. Module communication Connect Probe The optional integrated Temperature Probe has been disconnected or is not responsive. Reconnect Temperature Probe and try another measurement cycle. Check Cuff

(Weak Signal) Weak or no signal measured during blood pressure measurement. Check that the hose is connected. Check that the correct size Check that the cuff is in the correct position. Motion may be affecting cuff is being applied. Check Cuff

(Artifact) ability to take measurement. Check Cuff (Out Measurement is out of Check that there is no of Range) range. excessive clothing between Check Cuff Weak Signal when

(Measurement measurement is being Timeout) taken. arm and cuff. Retake another measurement. www.masimo.com 195 Masimo Chapter 13: Messages Root NIBPT Check Cuff

(Pneumatic Blockage) Check Cuff

(Inflate Timeout) hose. hose. Message Explanation Next Step May be a blockage in the air leaking air. Check that the cuff is not If problem still persists, contact Customer Service. May be a blockage in the air Check Cuff Weak Signal when

(Safety measurement is being Timeout) taken. Check Cuff

(Overpressure) May be due to a faulty cuff. Calibration Required Blood pressure measurement transducer may be out of range or Manual. Perform calibration procedures per User there has been a calibration If problem still persists, data failure. contact Customer Service. For additional messages, see Instructions for Use or Operator's Manuals for Radical-7, Radius-7, and MOC-9 modules. www.masimo.com 196 Masimo Chapter 14: Troubleshooting Troubleshooting Radical-7, Radius-7, and MOC-9 Modules For information on troubleshooting values that are provided from Radical-7, Radius-7, and MOC-9 modules, refer to their respective Instructions for Use or Operator's Manuals. Troubleshooting Root Symptom Possible Cause Correction Power Button not pressed long enough. seconds. Press Power Button for two (2) Root does not turn The battery may Connect Root to AC power to on. be depleted. charge battery. One of the fuses is not operating properly. Replace the fuse. See Replacing the Fuses on page 229. www.masimo.com 197 Masimo Root NIBPT Chapter 14: Troubleshooting Symptom Possible Cause Correction Root turns on, but The brightness Main Screen is dim setting is not or blank. correct. Adjust the brightness setting. See Brightness on page 110. If the condition persists, Root requires service. Contact Masimo Technical Services. See Return Procedure on page 247. Touch functionality is not responsive. Root requires service. Contact Internal failure. Masimo Technical Services. See Return Procedure on page 247. Not displaying data plugged in, or that the cable is from Radical-7, Radius-7, or MOC-9 modules. Connection error. Ensure that the connections are securely in place and properly not defective. For Radius-7, ensure that the device is paired with Root via Bluetooth. Refer to Operator's Manual of Radius-7 for more information. Iris screen does not display connection status for standalone devices. Connection error. Adapter. Unplug and replug the Iris www.masimo.com 198 Masimo Root NIBPT Chapter 14: Troubleshooting Symptom Possible Cause Correction Iris screen does not display connection status for Connection error. standalone devices. operators manual for the If the problem persists, refer to instructions for use or operator's manual for the connected standalone devices or Iris section of the instructions for use or appropriate version of Patient SafetyNet. To silence an alarm, press the Power Button for eight (8) seconds. If alarm continues to sound, Power Off Root. Root requires service. See Return Procedure on page 247. continuous speaker Internal failure. Root has a tone. To Power On when turned off or Power Button may in Sleep Mode, press Power need to be Button for two (2) seconds. Power Button does pressed for a not respond when longer time. pressed. To Power Off when turned on or in Sleep Mode, press the Power Button for eight (8) seconds. Internal failure. Root requires service. See Return Procedure on page 247. www.masimo.com 199 Masimo Root NIBPT Chapter 14: Troubleshooting Symptom Possible Cause Correction Home Button does not work when Internal failure. pressed. Root requires service. See Return Procedure on page 247. Battery does not charge. AC power cable may be disconnected. cable. Unplug and replug AC power Root Charging illuminates red. Indicator Internal failure. Root requires service. See Return Procedure on page 247. Nurse Call does not communicate. Connection error. Unplug and replug Nurse Call connector. See Nurse Call Setting Connections on page 245. Wi-Fi is not EMR Push icon enabled. does not appear in Root is not Action Bar. connected to Ensure Wi-Fi is enable. See Wi-Fi on page 105. If EMR Push icon does not appear, see Masimo Technical Services on page 248. Patient SafetyNet. Parameter is not Parameter does not appear in EMR Push screen. configured for See Masimo Technical Services EMR Push on on page 248. Patient SafetyNet. www.masimo.com 200 Masimo Root NIBPT Chapter 14: Troubleshooting Symptom Possible Cause Correction Unable to manually Parameter is not enter parameter configured for See Masimo Technical Services data in EMR Push manual entry on on page 248. screen. Patient SafetyNet. www.masimo.com 201 Masimo Chapter 15: Specifications This chapter contains specifications of Root. For information on the specifications of Radical-7, Radius-7, MOC-9 modules, and standalone devices, see Directions for Use or Operator's Manuals for these devices. Measurement Accuracy NIBP Pressure Transducer Between 0 mmHg and 300 mmHg 3mmHg Optional Integrated Temperature*

Temperature 110F (26.7C and 43.3C) Between 80F and All patient populations 0.2F

(0.11C)**

Temperature Number Clinical Limits of Clinical Measurement of Bias (C) Agreement Repeatability Site/Mode Subjects Oral 106 0.01 0.63 0.14 Rectal 105

-0.12 0.59 0.29 www.masimo.com 203 Masimo Root NIBPT Chapter 15: Specifications Pediatric Axillary 117

-0.03 0.56 0.14 Adult Axillary 105 0.13 0.43 0.14

*Test Report #:2010036 Test Report of Clinical Investigation to demonstrate that the SureTemp Plus thermometer meets the essential performance of clinical thermometers for body temperature measurement as described in ISO 80601-2-56:2009

**Applicable to Continuous Mode only. See Operation - Temperature on page 141. Alarms Audio Alarm System Status Audio Description Type Light Color High Priority Flashing Red 10-pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s Medium Flashing Yellow 3-pulse burst, pulse spacing: 0.375s, Priority 0.375s, repeat time: 7s Low Priority Solid Yellow No audio Nurse Call Specifications The Nurse Call relays have the following electrical specifications per switch:

www.masimo.com 204 Masimo Root NIBPT Chapter 15: Specifications Parameter Specification Max Voltage 36 VDC or 24 VAC peak Connectors Connector Type Number of Ports Ethernet 10/100 Mbps Nurse Call 1/4 inch round female MOC-9 Masimo Connector USB USB 2.0 Iris RS-232/RJ-45 NIBP Nib Male Bayonet Temperature MOLEX 52271-0690 1 1 3 2 4 1 1 Display Ranges NIBP www.masimo.com 205 Masimo Root NIBPT Chapter 15: Specifications Patient Population Measurement Display Range Adult Systolic 40-260 mmHg Pediatric Systolic 40-230 mmHg Diastolic 20-200 mmHg MAP 26-220 mmHg Diastolic 20-160 mmHg MAP 26-183 mmHg Diastolic 20-100 mmHg MAP 26-110 mmHg Neonatal Systolic 40-130 mmHg Optional Integrated Temperature Measurement Display Range Temperature 80-110F (26.7-43.3C) Pulse Rate www.masimo.com 206 Masimo Root NIBPT Chapter 15: Specifications Measurement Display Range Pulse Rate (PR) 30-220 bpm NIBP Pressurization Ranges Weight Patient Initial Maximum Category Pressurization Pressure Greater than 75 lbs Adult 160 mmHg 280 mmHg Between 15.4 - 75 lbs Pediatric 140 mmHg 280 mmHg Less than 15.4 lbs (7 Neonatal 90 mmHg 140 mmHg

(34 kg)

(7 - 34 kg) kg) Electrical Root AC Power requirements 100-240 VAC~, 47-63 Hz, 180 VA (Max) www.masimo.com 207 Masimo Root NIBPT Chapter 15: Specifications 2 Amp, Time Delay High Breaking Capacity

(5x20mm), 250V Root Fuses (2) Battery Type Lithium Ion Voltage 10.8V (Nominal) Capacity 4 hours*

Maximum Charging Time 4 hours charged battery. Environmental Root

*This represents approximate run time at the lowest brightness, using a fully Operating Temperature 50F to 104F (10C to 40C) Transport/Storage Temperature -4F to 122F (-20C to 50C) Operating Humidity 10% to 95%, non-condensing Storage Humidity 10% to 95%, non-condensing www.masimo.com 208 Masimo Root NIBPT Chapter 15: Specifications Operating Air Pressure

-1000 ft to 18,000 ft 500 mbar to 1060 mbar

(-304 m to 5,486 m) Touchscreen Display Characteristic Description Type Backlit Active Matrix TFT LCD Resolution 1280 x 800 pixels Size 10.1 in (25.65 cm) Diagonal Color 24 bit RGB Touchscreen Type Multi-Touch P-Cap Wireless Specifications Communication (Wi-Fi) Type WLAN Radio: IEEE 802.11 a/b/g Root www.masimo.com 209 Masimo Root NIBPT Chapter 15: Specifications Communication (Wi-Fi) Frequency 5.0 GHz - 802.11a/n: 5150-5250 MHz, 5250-5350 2.4 GHz - 802.11b/g/n: 2412-2472 MHz MHz, 5470-5725 MHz, 5725-5825 MHz Available Data Rates 802.11b - 1, 2, 5.5, 11 Mbps. 802.11a - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. 802.11g - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. Max Peak Output Power 18 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types OFDM, BPSK, CCK Modulation Signals Analog and Digital Communication (Bluetooth) Type Bluetooth Frequency 2402-2480 MHz Max Peak Output Power 12 dBm www.masimo.com 210 Masimo Root NIBPT Chapter 15: Specifications Communication (Bluetooth) Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types DH5 Modulation Signals Analog and Digital Available Data Rates 1,2,3 Mbps Security and Authentication Radio Compliance USA FCC ID: VKF-MWM2 Model: RDS-7A or RDS-7 Encryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES Open System, Shared Key, Pre-Shared Key (PSK), 802.1X:

Authentication LEAP, PEAP< TTLS, TLS, EAP-FAST www.masimo.com 211 Masimo Root NIBPT Chapter 15: Specifications Radio Compliance Canada IC:7362A-MWM2 Model: RDS-7A or RDS-7 RSS-247 Europe EU Radio Equipment Directive

(RED 2014/53/EU) EN 300 328:V2.1.1 EN 301 893:V2.1.1 EN 301 489-1:V2.2.0 EN 301 489-17 V3.1.1 EN 62311 Japan TELEC Article 2-1-19 Article 2-1-19-3 Article 2-1-19-3-2 Korea KN 301 489-1 V2.2.0 KN 301 489-17 V3.1.1 Compliance Electrical Safety ANSI/AAMI ES 60601-1:2005 www.masimo.com 212 Masimo Root NIBPT Chapter 15: Specifications Electrical Safety CAN/CSA C22.2 No. 60601-1:2008 EN 60601-1:1990 + AI: 1993 + A2:1995 IEC 60601-1:2005 + A1: 2012 IEC 60601-1-8:2006 IEC 60601-2-49:2011 IEC 80601-2-30:2009 ISO 80601-2-56:2012 NIBP Module Standards AAMI SP10:2002 ISO 81060-2:2009 EN 1060-1:1996 +A2:2009 EN 1060-3:1997 +A2:2009 EN 1060-4:2004 www.masimo.com 213 Masimo Root NIBPT Chapter 15: Specifications EMC Compliance EN 60601-1-2;2007, Class B Equipment Classification per IEC 60601-1 Type of Protection Class I (on AC power) Internally powered (on battery power) Degree of Protection of Electrical Defibrillation proof BF-Applied Part1 Shock Protection against harm from IPX1 Protection against liquid drops liquid ingress falling vertically. Mode of Operation Continuous Operation 1Connected devices should be used in accordance with their respective degrees of electrical protection to maintain electrical safety. www.masimo.com 214 Masimo Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Emissions Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment - Guidance ME Equipment uses RF energy only for its internal function. Therefore, its RF Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class A Class A For hospital environment only. Not intended for use in a domestic environment. RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations /

IEC 61000-3-3 Flicker Emissions Complies www.masimo.com 215 Masimo Root NIBPT Chapter 15: Specifications www.masimo.com 216 Masimo Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Immunity Guidance and Manufacturer's Declaration - Electromagnetic Immunity The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment - Guidance Electrostatic

+6 kV

+6 kV Floors should be wood, discharge (ESD) contact contact concrete or ceramic tile. If IEC 61000-4-2

+8 kV air

+8 kV air floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast

+2 kV for Mains power quality transient/burst power supply should be that of a typical IEC 61000-4-4 lines. commercial or hospital

environment.

+1 kV for input/output lines. www.masimo.com 217 Masimo Guidance and Manufacturer's Declaration - Electromagnetic Immunity Voltage dips, 100% for 0.5 Mains power quality short cycle should be that of a typical Root NIBPT Surge IEC 61000-4-5 interruptions and voltage variations on power supply input lines. IEC 61000-4-11

(50 / 60 Hz) magnetic field. IEC 61000-4-8

+1 kV -

differential mode

+2 kV -

common mode 60% for 5 cycles 30% for 25 cycles 100% for 5 seconds Chapter 15: Specifications Mains power quality should be that of a typical hospital environment.

commercial or hospital environment. Root

provides a battery for continued operation during power mains interruption for a maximum of 4 hours. magnetic fields should be at levels characteristic of typical location in a typical hospital environment. Power frequency 3 A/m 3 A/m Power frequency Portable and mobile RF communications equipment should be used no closer to any part of the ME Equipment, including cables, than the recommended separation distance calculated from the equation applicable www.masimo.com 218 Masimo Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity to the frequency of the transmitter. Immunity Test IEC 60601 Compliance Recommended Test Level Level Separation Distance Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m 80 MHz to 800 MHz:

IEC 61000-4-3 80 MHz to 2.5 GHz 800 MHz to 2.5 GHz:

www.masimo.com 219 Masimo Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity

where P is the maximum output power rating of the transmitter in watts

(W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. www.masimo.com 220 Masimo Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity

(a) Field strengths from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ME Equipment is used exceeds the applicable RF compliance level above, the ME Equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment.

(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. Recommended Separation Distances Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME Equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ME Equipment as recommended below, according to the maximum output power of the communication equipment. www.masimo.com 221 Masimo Root NIBPT Chapter 15: Specifications Rated maximum Separation Distance According to Frequency of output power of Transmitter (m) transmitter (W) 150 K Hz to 80 80 MHz to 800 800 MHz to MHz MHz 2.5GHz d = 1.17*Sqrt (P) d = 1.17*Sqrt (P) d = 2.33*Sqrt (P) 0.01 0.1 1 10 100 0.12 0.37 1.17 3.7 11.7 0.12 0.37 1.17 3.7 11.7 0.23 0.74 2.33 7.37 23.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. www.masimo.com 222 Masimo Root NIBPT Symbols Chapter 15: Specifications The following symbols may appear on the product or product labeling:

Symbol Description Symbol Description Follow instructions for Consult instructions for use use ETL Intertek certification See Declarations on Page 1 for certifications Fuse replacement-

Only replace with time-delay fuses specified in this Instructions for Use Mark of conformity to European medical device directive 93/42/EEC Protection against vertically falling water drops Defibrillation-proof. Type BF applied part Type BF applied part NIBP Arm Circumference www.masimo.com 223 Masimo Root NIBPT Chapter 15: Specifications Symbol Description Symbol Description Artery symbol and Cuff index line must arrow should be placed over brachial or femoral artery fall within range markings for an accurate measurement Index Line Non-Sterile Authorized representative in the European community Caution: Federal (USA) law restricts this device to sale by or on the order of a physician Non-ionizing electromagnetic radiation Warning, electricity Separate collection for electrical and electronic equipment

(WEEE) Recyclable Federal Communications Commission (FCC) Licensing Identifies unit has been registered as a radio device www.masimo.com 224 Masimo Root NIBPT Chapter 15: Specifications Symbol Description Symbol Description Electrostatic Industry Canada Identification No parameter alarms Biohazardous Waste Not for continuous monitoring (No alarm for SpO2) Product contains no PVC (polyvinyl chloride) material Not made with natural rubber latex Masimo reference number Serial number Caution Catalog number

(model number) Manufacturer Date of manufacture YYYY-MM-DD Storage temperature range Keep dry Fragile, handle with care Storage humidity Do not use if package limitation is damaged www.masimo.com 225 Masimo Root NIBPT Chapter 15: Specifications Symbol Description Symbol Description Atmospheric pressure Equipotential Ground limitation Terminal AC current Fuse Wireless Symbol level Wireless features can be used in member states with the restriction of indoor use in France -Class 2 wireless device Stand-By Iris Connection RS-232 Interface Ethernet Analog Out Interface Nurse Call Interface Greater than USB port Less than China Restriction of Hazardous Substances www.masimo.com 226 Masimo Root NIBPT Chapter 15: Specifications Symbol Description Symbol Description

The names and content of the toxic and hazardous substances or elements shall be provided in the product instruction manual Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available in all countries. www.masimo.com 227 Masimo Chapter 16: Service and Maintenance This chapter contains information about cleaning, battery operation, performance verification, service, repair and warranty. Cleaning Root is a non-sterile and reusable device. The surface of the Root should be cleaned when the device is visibly dirty, before and after each procedure, and/or according to hospital practice. To surface clean, wipe down the outer surface of Root using any of the following:

Cidex Plus (3.4% glutaraldehyde) 10% bleach solution 70% isopropyl alcohol solution Do not allow liquids to enter the interior of Root. Using the recommended cleaning solutions on the touchscreen will not affect the performance of Root. Replacing the Fuses If a power-related problem causes one or both of the fuses to fail, the fuse(s) will need to be replaced. Replace fuse(s) with UL Listed fuses rated 250V, 2 amp, metric 5x20 mm and with a time delay breaking capacity of minimum 1500A. screwdriver. WARNING: To ensure safety, only replace with appropriately rated fuses. The fuses can be removed by hand or with a 5-millimeter or 3/16-inch www.masimo.com 229 Masimo Root NIBPT Chapter 16: Service and Maintenance To replace the fuse(s) 1. Power Off Root completely. Do not put in Sleep Mode. See Sleep and Power Off on page 138. 2. Remove the AC power cord from the Power Entry Module in the 3. Remove the fuse holder by pulling it forward from the Power Entry 4. Remove a fuse by gently pulling the top of the fuse away from the center and then pulling up. The fuse should easily be removed. Do back panel. Module. not force. 5. Place a new fuse in the fuse holder. 6. If replacing both fuses, repeat steps 4 and 5 for the second fuse. 7. Slide the fuse holder back into the Power Entry Module and press firmly to make sure it is secure. Root is ready to be reconnected to AC power. If the fuses fail shortly after replacement, Root requires service. See Repair Policy on page 247. www.masimo.com 230 Masimo Root NIBPT Chapter 16: Service and Maintenance Power-On Self Test To conduct a Power-On Self Test 1. Connect Root to AC power, and verify that the AC Power Indicator 2. Power On Root. Within five (5) seconds, all available indicators will illuminate, the device will emit a tone, and the Masimo logo will is illuminated. display. NIBP Module Calibration Test Note: This section is provided as a reference and intended for authorized service personnel only. Pass Criteria International standards for automated NIBP devices require that the maximum static pressure accuracy shall be 3mmHg or 2% or the reading, whichever is greater. This is a stringent requirement and all test equipment must be in excellent working order to properly perform this test. It is important to verify the calibration before changing it. Historical data has shown that the transducers rarely need to be re-calibrated although we still suggest that the calibration be verified annually. Equipment Calibrated Manometer*

Pneumatic "T" Adapters Hand Bulb 500mL bottle or regular-sized cuff wrapped around solid object www.masimo.com 231 Masimo Root NIBPT Chapter 16: Service and Maintenance Connection Tubing

*Verify the manometer has been calibrated within the last 12 months. Calibration accuracy shall be within 0.02% to 0.25% FS (Full Scale) and a measurement uncertainty of 1 LSD (Least Significant Digit). www.masimo.com 232 Masimo Root NIBPT Chapter 16: Service and Maintenance Procedure 1. Connect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb to the NIBP module using "T" adapters and connection tubing. 2. Power ON the manometer. Verify the manometer has been zeroed. Set the unit of measurement to mmHg. Verify the manometer has been calibrated. 3. Power ON the Root. 4. On the Root home screen, press the Main Menu icon

. www.masimo.com 233 Masimo Root NIBPT Chapter 16: Service and Maintenance 5. Press NIBP

. 6. Press CALIBRATION

. For the password, enter 4258. Press the Enter key. 7. Press CALIBRATION TEST

. 8. Press Test. 9. Apply various pressures (0mmHg to 280mmHg) to the NIBP module with the hand bulb. 10. Compare the NIBP module pressure to the manometer pressure:

If the NIBP module pressure and manometer pressure differ WITHIN the 3mmHg tolerance, then the NIBP module has PASSED the calibration test and no further action is needed. Go to step 11. If the NIBP module pressure and manometer pressure differ BEYOND the 3mmHg tolerance, (1) perform the Zero Point Calibration, (2) then perform the Span Point Calibration. See Zero Point Calibration on page 235 and Span Point Calibration on page 235. If the NIBP module pressure and manometer pressure still differ BEYOND the 3mmHg tolerance, contact Masimo Technical Services. See Masimo Technical Services on page 248. 11. Disconnect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb from the NIBP module. 12. Power OFF the manometer. www.masimo.com 234 Masimo Root NIBPT Chapter 16: Service and Maintenance Zero Point Calibration Zero Point Calibration is performed when an NIBP module does NOT PASS the NIBP Module Calibration Test. See the NIBP Module Calibration Test on page 231. service personnel only. Note: This section is provided as a reference and intended for authorized 1. Press the back button in the upper-left corner of the CALIBRATION TEST screen to go back to the CALIBRATION menu screen. 2. Select ZERO POINT CALIBRATION

. 3. Apply 0 (zero) mmHg to the NIBP module. Note: The 0 (zero) mmHg can be verified on the manometer. 4. Press Calibrate to start the Zero Point Calibration:

A "Success" message will appear if the calibration was successful. Go to step 5. If a "Result Failure" message appears, verify the 0 (zero) mmHg is applied to the NIBP module and press Calibrate again. If the

"Result Failure" message is repetitive, contact Masimo Technical Services. See Masimo Technical Services on page 248. 5. After a successful Zero Point Calibration, complete the Span Point Calibration. See Span Point Calibration on page 235. www.masimo.com 235 Masimo Root NIBPT Chapter 16: Service and Maintenance Span Point Calibration Span Point Calibration is performed when an NIBP module does NOT PASS the NIBP Module Calibration Test, and after completing Zero Point Calibration. See the NIBP Module Calibration Test on page 231 and Zero Point Calibration on page 235 before completing the instructions below. Note: This section is provided as a reference and intended for authorized service personnel only. 1. After successful completion of Zero Point Calibration, press the back button in the upper-left corner of the ZERO POINT CALIBRATION screen to go back to the CALIBRATION menu screen. 2. Select SPAN POINT CALIBRATION

. 3. Press Close Valve. 4. Use the hand bulb to apply exactly 250mmHg to the NIBP module, then press Calibrate. A "Success" message will appear if the calibration was successful. Go to step 5. If a "Result Failure" message appears, repeat the test by applying 250mmHg to the NIBP module and pressing Calibrate. If the "Result Failure" message is repetitive, contact Masimo Technical Services. See Masimo Technical Services on page 248. 5. After successful Span Point Calibration, press the back button to go back to the CALIBRATION menu screen. 6. Press CALIBRATION TEST

. 7. Press Test. www.masimo.com 236 Masimo Root NIBPT Chapter 16: Service and Maintenance 8. Apply various pressures (0mmHg to 280mmHg) to the NIBP module with the hand bulb. 9. Compare the NIBP module pressure to the manometer pressure:

If the NIBP module pressure and manometer pressure differ WITHIN the 3mmHg tolerance, then the NIBP module has PASSED the calibration test and no further action is required. Note: For pass criteria, see the NIBP Module Calibration Test If the NIBP module pressure and manometer pressure still differ BEYOND the 3mmHg tolerance, contact Masimo Technical Services. See Masimo Technical Services on page Go to step 10. on page 231. 248. 10. Disconnect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb from the NIBP module. 11. Power OFF the manometer. www.masimo.com 237 Masimo Root NIBPT Chapter 16: Service and Maintenance Note: This section is provided as a reference and intended for authorized International standards for automated NIBP devices require that air leakage within the pneumatic system must not exceed 6mmHg/minute. NIBP Air Leak Test service personnel only. Pass Criteria Equipment Calibrated Manometer*

Pneumatic "T" Adapters 500mL bottle Hand Bulb Connection Tubing

*Verify the manometer has been calibrated within the last 12 months. Calibration accuracy shall be within 0.02% to 0.25% FS (Full Scale) and a measurement uncertainty of 1 LSD (Least Significant Digit). www.masimo.com 238 Masimo Root NIBPT Chapter 16: Service and Maintenance Procedure 1. Connect the manometer, 500mL bottle, and hand bulb to the NIBP module using "T" adapters and connection tubing. 2. Power ON the manometer. Set the unit of measurement to mmHg. Verify the manometer has been calibrated. 3. Power ON the Root. 4. On the Root home screen, press the Main Menu icon

. 5. Press NIBP

. 6. Press CALIBRATION

. www.masimo.com 239 Masimo Root NIBPT Chapter 16: Service and Maintenance For the password, enter 4258. Press the Enter key. 7. Press AIR LEAK TEST

. 8. To begin the air leak test, press Test. Wait for the countdown timer to reach 0 second. At the bottom of the screen, in the Result section, verify the leak rate is less than 6mmHg. If the leak rate is greater than 6mmHg, verify there are no leaks in the calibration equipment

(tubing, 500mL container, arm cuff, etc.). If there are no leaks detected from the calibration equipment and the leak rate is still greater than 6mmHg, contact Masimo Technical Services. See Masimo Technical Services on page 248. 9. Disconnect the manometer, 500mL bottle, and hand bulb from the NIBP module. 10. Power OFF the manometer. Note: This section is provided as a reference and intended for authorized Overpressure Test service personnel only. Pass Criteria International standards for automated NIBP devices require that the pressure must not exceed 300mmHg on adults and pediatric patients and 150mmHg on neonatal patients with a tolerance of 10% for 15 seconds or greater than 10% for 3 seconds. The overpressure pass criteria for the Advantage module are:

www.masimo.com 240 Masimo Root NIBPT Chapter 16: Service and Maintenance Adults, Pediatrics 300 10mmHg Neonates 150 5mmHg Equipment Calibrated Manometer*

Pneumatic "T" Adapters Hand Bulb Connection Tubing 500mL bottle or regular-sized cuff wrapped around solid object

*Verify the manometer has been calibrated within the last 12 months. Calibration accuracy shall be within 0.02% to 0.25% FS (Full Scale) and a measurement uncertainty of 1 LSD (Least Significant Digit). www.masimo.com 241 Masimo Root NIBPT Chapter 16: Service and Maintenance Test Method for Adults and Pediatrics 1. Connect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb to the NIBP module using "T" adapters and connection tubing. Note: If using a cuff, verify the cuff is Adult or Pediatric. Do not use a Neonate cuff for this test method. 2. Power ON the manometer. Set the unit of measurement to mmHg. Verify the manometer has been calibrated. 3. Power ON the Root. 4. On the Root home screen, press the Main Menu icon

. www.masimo.com 242 Masimo Root NIBPT Chapter 16: Service and Maintenance 5. Press NIBP

. 6. Press CALIBRATION

. For the password, enter 4258. Press the Enter key. 7. Press OVERPRESSURE TEST

. 8. To begin the overpressure test, press the Test button, then increase the pressure to the overpressure point:

Increase pressure to approximately 280mmHg using the hand Very slowly increase the pressure as you approach the bulb. overpressure point. When the overpressure point is reached, the valves will open

(a faint click can be heard when this occurs) and the pressure will rapidly reduce to 0 (zero) mmHg. Be sure to observe the pressure measurement on the manometer when the valves open. 9. Determine if the NIBP module passed the overpressure test:

If the valves opened WITHIN the overpressure pass criteria, then the NIBP module PASSED the overpressure test for adults and pediatrics. Go to step 10. If the valves opened BEYOND the overpressure point pass criteria, then press the Test button again to confirm the overpressure point. If the valves open repetitively beyond the pass criteria, contact Masimo Technical Services. See Masimo Technical Services on page 248. 10. To stop testing, press Stop. www.masimo.com 243 Masimo Root NIBPT Chapter 16: Service and Maintenance 11. Disconnect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb from the NIBP module. 12. Power OFF the manometer. Test Method for Neonates 1. Follow steps 1 through 3 from Test Method for Adults and Pediatrics above. Note: If using a cuff, verify the cuff is Neonate. Do not use an Adult or Pediatric cuff for this test method. 2. On the Root Main Screen, touch the Profiles option in the Status Bar. See About the Status Bar on page 53. 3. Select Neonates in the Profiles screen, then touch OK. 4. Start the NIBP measurement then immediately abort:

Touch the Start NIBP button. Touch the Start NIBP button again when then pump starts to inflate the system. 5. Press the Main Menu icon 6. Press NIBP

. 7. Press CALIBRATION

. For the password, enter 4258. Press the Enter key. 8. Press OVERPRESSURE TEST

. 9. To begin the overpressure test, press the Test button, then increase the pressure to the overpressure point:

www.masimo.com 244 Masimo Root NIBPT Chapter 16: Service and Maintenance Increase pressure to approximately 130mmHg using the hand Very slowly increase the pressure as you approach the bulb. overpressure point. When the overpressure point is reached, the valves will open

(a faint click can be heard when this occurs) and the pressure will rapidly reduce to 0mmHg. Be sure to observe the pressure measurement on the manometer when the valves open. 10. Determine if the NIBP module passed the overpressure test:

If the valves opened WITHIN the overpressure pass criteria, then the NIBP module PASSED the overpressure test for neonates. Go to step 11. If the valves opened BEYOND the overpressure point pass criteria, then press the Test button again to confirm the overpressure point. If the valves open repetitively beyond the pass criteria,contact Masimo Technical Services. See Masimo Technical Services on page 248. 11. To stop testing, press Stop. 12. Disconnect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb from the NIBP module. 13. Power OFF the manometer. Nurse Call Setting Connections For maximum flexibility, either normally open or normally closed signals are available. During an alarm condition or a low Signal IQ event, depending on the configuration of the device output, the normally open pin will be connected to the common pin, and the normally closed pin will be www.masimo.com 245 Masimo Root NIBPT Chapter 16: Service and Maintenance disconnected. In addition, the Nurse Call Polarity can be inverted to accommodate various nurse call station requirements. See Device Output on page 116. Only authorized service personnel should connect one of these two signals to a hospitals Nurse Call system. Cable Type Nurse Call Event Menu Setting 2-Circuit opened Normal 2 contacts normally Nurse Call Polarity 3-Circuit closed 2 and 3 contacts normally 2 contacts normally closed Nurse Call Polarity Inverse 1 and 2 contacts normally Nurse Call Polarity opened Normal 1 and 2 contacts normally Nurse Call Polarity closed Inverse 2 and 3 contacts normally opened Battery Test To conduct a Battery Test 1. Fully charge Root by connecting it to AC power. 2. Verify that the Root Charging Indicator is illuminated. www.masimo.com 246 Masimo Root NIBPT Chapter 16: Service and Maintenance 3. When Root is fully charged, the Root Charging Indicator turns off. 4. Power On Root and verify that the Root Battery Indicator icon on the Status Bar shows a full charge. Repair Policy repaired. Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the device Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning on page 229. Make sure the equipment is fully dry before packing. To return the device for service, see Return Procedure on page 247. Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning on page 229. 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 Root. 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 Root is not under warranty, or for tracking purposes if it is. www.masimo.com 247 Masimo Root NIBPT Chapter 16: Service and Maintenance 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 Root has been decontaminated for Return the Root to the shipping address listed in Contacting bloodborne pathogens. Masimo. Masimo Technical Services To contact Masimo Technical Services, refer to the Masimo Technical Services web page:

http://www.masimo.co.uk/company/global-services/technical-services/

Contacting Masimo Masimo Corporation 52 Discovery Irvine, California 92618 Tel:+1 949 297 7000 Fax:+1 949 297 7001 Limited Warranty Masimo warrants to the original end-user purchaser the Masimo-branded hardware product (Root with noninvasive blood pressure and temperature

) and any software media contained in the original packaging against defects in material and workmanship when used in accordance with www.masimo.com 248 Masimo Root NIBPT Chapter 16: Service and Maintenance Masimos user manuals, technical specifications, and other Masimo published guidelines for a period of 12 months and any batteries for six (6) months from the original date the Product was obtained by the end-user Masimos sole obligation under this warranty is the repair or replacement, at its option, of any defective Product or software media that is covered under To request a replacement under warranty, Purchaser must contact Masimo and obtain a returned goods authorization number so that Masimo can track the Product. If Masimo determines that a Product must be replaced under warranty, it will be replaced and the cost of shipment covered. All other shipping costs must be paid by purchaser. purchaser. the warranty. Exclusions The warranty does not apply to any non-Masimo branded product or any software, even if packaged with the Product, or any Product that was: (a) not new or in its original packaging when supplied to purchaser; (b) modified without Masimos written permission; (c) supplies, devices, or systems external to the Product; (d) disassembled, reassembled, or repaired by anyone other than a person authorized by Masimo; (e) used with other products, like new sensors, reprocessed sensors, or other accessories, not intended by Masimo to be used with the Product; (f) not used or maintained as provided in the operators manual or as otherwise provided in its labeling; (g) reprocessed, reconditioned, or recycled; and (h) damaged by accident, abuse, misuse, liquid contact, fire, earthquake or other external cause. www.masimo.com 249 Masimo Root NIBPT Chapter 16: Service and Maintenance No warranty applies to any Product provided to Purchaser for which Masimo, or its authorized distributor, is not paid; and these Products are provided AS-IS without warranty. Limitation of Warranty Except as otherwise required by law or altered by the purchase agreement, the above warranty is the exclusive warranty that applies to the Product and software media, and Masimo does not make any other promises, conditions, or warranties regarding the Product. No other warranty applies, express or implied, including without limitation, any implied warranty of merchantability, fitness for a particular purpose, satisfactory quality, or as to the use of reasonable skill and care. See the licensing terms for the terms and conditions that apply to and Software accompanying the Product. Additionally, Masimo will not be liable for any incidental, indirect, special, or consequential loss, damage, or expense arising from the use or loss of use of any Products or Software. In no event shall Masimos liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software. The above limitations do not preclude any liability that cannot legally be disclaimed by contract. 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 www.masimo.com 250 Masimo Root NIBPT Chapter 16: Service and Maintenance 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. 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 Purchasers 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 www.masimo.com 251 Masimo Root NIBPT Chapter 16: Service and Maintenance without Masimo's prior written consent; except that the Software and all of Purchasers rights hereunder shall transfer automatically to any 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 State 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. www.masimo.com 252 Masimo Appendix: Concepts of Alarm Response Delay Concepts of Alarm Response Delay As with any patient monitors, the audible and visual alarms are subject to alarm response delay, which is composed of Alarm Condition Delay and Alarm Signal Generation Delay. Alarm Condition Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists. While Alarm Signal Generation Delay is the time from the onset of an alarm condition to the generation of its alarm signal. The graphic below is a simplified illustration of the concept of alarm response delay using a pulse oximeter that measures SpO2 as an example. The graphic does not reflect actual lengths of delays. Reference Definition 1 SaO2 www.masimo.com 253 Masimo Root NIBPT Appendix: Concepts of Alarm Response Delay Reference Definition Alarm Limit Displayed SpO2 2 3 4 Alarm Signal Generation SpO2 Saturation t Time The Alarm Condition Delay is graphically represented as t2 t1 in the figure above to show the delay due to processing and averaging. The Alarm Signal Generation Delay is graphically represented as t3 t2 in the figure above to show the delay due to alarm system strategy and communication time. The overall alarm system delay time is graphically represented as t3 t1. For more information about alarm response delay, refer to IEC 60601-1-8. www.masimo.com 254 Masimo Index A About 49, 74 Alarms 134 Alarms for Temperature 54, 55 Appendix 163 Concepts of Alarm Response Delay About the Action Bar 36, 82 Attach NIBP Cuff 31 About the Main Screen 33, 67 Attach the Probe Well 30 About the Status Bar 27, 28, 34, Attach the Temperature Probe 65, 66, 67, 68, 69, 80, 119, 120, 31 Accessing Main Menu Options Back View 22 158 About This Manual 7 AC Power Indicator 27, 86 Access Control 63, 64, 70 34, 36, 49 Active Channels 50, 51 Additional Settings for Layouts Additional Settings for NIBP 58, 50, 53 62 Additional Settings for Temperature 54, 57 Admitting a Patient 104 Alarm Interface 77 Alarm Silence 34, 79 Audio Pause 34, 63, 73, 80 Available Layouts 50, 51 B C Battery Test 160 Bluetooth 35, 64, 68, 123 Bluetooth Devices 31 Brightness 64, 69, 129 Calibration for NIBP 58, 63 Capturing Screens 83 Chapter 1 Description 21 www.masimo.com 255 Masimo Index Admit and Discharge to Patient SafetyNet 36, 103 Chapter 7 Electronic Medical Record (EMR) Push 36, 109 Chapter 8 Radical-7 111 Chapter 9 Radius-7 113 Cleaning 149, 160 Cleaning and Service Warnings and Cautions 18 Compliance 139 Compliance Warnings and Cautions 18 Concepts of Alarm Response Delay 163 Connect Device to Root 123 Connecting Root to Patient SafetyNet 67 Connectors 134 Contacting Masimo 161 Contraindication 11 Root NIBPT Chapter 10 MOC-9 30, 115 Chapter 11 Iris 35, 50, 117 Chapter 12 Bluetooth Devices 31, 123 Chapter 13 Messages 125 Chapter 14 Troubleshooting 129 Chapter 15 Specifications 133 Chapter 16 Service and Maintenance 149 Chapter 2 Setting Up 25 Chapter 3 Operation 33 Chapter 4 Chapter 5 Chapter 6 Temperature Measurement 89 NIBP Measurement 31, 93 www.masimo.com 256 Masimo Root NIBPT Index Cuff Selection and Placement Front View 21 93, 95, 97, 99, 101 Customizing Windows 37, 46, G Determining EMR Push is Active Guidance and Manufacturer's Device Output 30, 34, 65, 72, Immunity 142 Guidance and Manufacturer's Declaration-Electromagnetic Emissions 141 Declaration-Electromagnetic Guidelines for Setting Up 25 Device Settings 49, 64 Discharging a Patient 105 I Display Ranges 135 Indications for Use 9 Downloading Screen Captures Initial Battery Charging 25, 27 53, 54 D 109 159 85 E IntelliBridge Connectivity 73 Intended Use 9 Intervals for NIBP 58, 61 Iris 76 Iris Icon 119 Iris Screen 76, 120 K Kite 17, 35, 64, 66 Electrical 136 Environmental 25, 136 Ethernet 35, 64, 67 Exclusions 161 Features 21 F www.masimo.com 257 Masimo Root NIBPT Index L M Layout 49, 50 Lights 86 Limited Warranty 161 Localization 35, 64, 65 N NIBP 49, 58 NIBP Air Leak Test 154 63, 150, 152, 153 NIBP Pressurization Ranges 136 Noninvasive Blood Pressure 14, 17 Limitation of Warranty 161 NIBP Module Calibration Test Manual Sizing of Windows 48 Not Admitted 103 Manually Entering Patient Data Not Monitoring Message 106 109, 110 Nurse Call Connection 30 Masimo Kite 31 Nurse Call Setting Connections Masimo Technical Services 109, 130, 159 110, 130, 131, 152, 153, 156, Nurse Call Specifications 134 158, 159, 160 Mean Arterial Pressure (MAP) O 58, 61 Operation - NIBP 95 Measurement Accuracy 133 Operation - Temperature 89, Menu Navigation 40 133 MOC-9 Connection 29 Optional Integrated Temperature Monitoring Resumed Message 15, 17 107 Overpressure Test 156 www.masimo.com 258 Masimo Root NIBPT Index Parameter Settings for NIBP 58 Parameters Supported 74 Patient Conditions 94 Patient Measurement Mode 93 Patient SafetyNet System 18 Performance Warnings and Cautions 15 Power On 26 Power-On Self Test 150 Product Description and Features 9 Product Description and Features, Intended Use and Indications for Use 9 Profiles 36, 49, 75, 93 Pulse Rate (PR) 58, 60 Radical-7 and Radius-7 Battery 64, 69 P R Radical-7 Connection 28 Radius-7 Connection 29 Rainbow 49, 54 Recommended Separation Distances 144 Repair Policy 149, 160 Replacing the Fuses 129, 149 Restrictions 162 Return Procedure 25, 129, 130, 160 Root Battery 27, 64, 68 Root Charging Indicator 35, 87 S 13 Safety Information, Warnings, and Cautions 13, 27 Safety Warnings and Cautions Sales & End-User License Agreement 162 Screen Capture 83 Sending Patient Data to the EMR Radical-7 and Radius-7 Charging Indicator 28, 35, 87 110 www.masimo.com 259 Masimo Session Management 36, 71, 82 Root NIBPT Set Mode Automatic 61, 97 Schedule 62, 101 Stat 62, 99 Index Trends for NIBP 60 Trends for Temperature 54, 56 Troubleshooting Radical-7, Radius-7, and MOC-9 Side Views 24, 86 Modules 129 Sleep and Power Off 26, 88, 149 Troubleshooting Root 129 Sounds 35, 49, 63, 70, 80 Span Point Calibration 152, 153 U Spot Check Measurement 95 Understanding Windows 41 Standby Mode 34, 71, 80 Unpacking and Inspection 25 Symbols 145 Using Analog View 42, 44 System Status Lights 24, 86 Using Iris Connectivity Ports Systolic/Diastolic (SYS/DIA) 58, Using MOC-9 Ports 115 Using the Touchscreen Interface Using Trend View 42, 43 118 36 W Z Temperature Probes 91 Wi-Fi 35, 64, 66, 130 Touchscreen Display 137 Wireless Specifications 137 www.masimo.com 260 Masimo Zero Point Calibration 152, 153 59 T Taking Temperature Measurement 89 Temperature 49, 54 Trend Download 81 Trend Settings 49, 75 Root NIBPT Index www.masimo.com 261 Masimo www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520 www.masimo.com 38280/LAB-9274K-0520

Figure 1: Front view of MWMII with antenna (P/N: 1000672) Figure 2: Rear view of MWMII with antenna (P/N: 1000672) Figure 3: Front view of MWMII with antenna (P/N 9000129) Figure 4: Rear view of MWMII with antenna (P/N 9000129) Figure 5: Radio module with the shield removed

R .025

.048

+/- .010 1.39

+/- .015 Model: Rad-97 Assembled in Mexico IP22 Bluetooth MAC address XX-XX-XX-XX-XX-XX Wi MAC address XX-XX-XX-XX-XX-XX Ethernet MAC address XX-XX-XX-XX-XX-XX Patents: www.masimo.com/patents Contains: FCC ID: VKF-MWM2 Contains: FCC ID: VKF-MWM2 Contains: IC: 7362A-MWM2 Contains: IC: 7362A-MWM2 300772/7607B-0520

.064

+/- .010 1.30

+/- .015 Color Requirements and inspection dimensions (actual size ) Production Artwork (actual size) Label, MAC Address, Rad-97, MWMII LAB-7607 Rev. B CO-062069 05/20 die line - do not print

*Phantom box for XXX-X-XXX will be for reference only, digit format will change

To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 03-09-2023 Ref: Attestation Statements Part 2.911(d)(7) Filing FCC ID: VKF-MWM2 Masimo Corporation certifies that, as of the date of the filing of the application, (insert U.S. agent company name) is our designated U.S. agent for service of process for the above referenced FCC ID. Masimo Corporation accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Anamidevi Joshi accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service of process for the above referenced FCC ID.

Designated U.S. Agent Information 0016600161 Name: Masimo Corporation Address: 52 Discovery, Irvine, CA, U.S.A. 92630 Contact Person: Anamidevi Joshi Tel.: 949-297-7663 Email: ajoshi@masimo.com Sincerely,

[Insert U.S. agent company name]

(U.S. agent company name printed name)

(U.S. agent company name signature) Masimo Corporation Masimo Corporation

[Insert applicant name]

(Applicant printed name)

(Applicant signature) Masimo Corporation Masimo Corporation Rev 1/26/2023

Date: 03-09-2023 To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Ref: Attestation Statements Part 2.911(d)(5)(i) and Part 2.911(d)(5)(ii) Filing Re. KDB 986446 D01 FCC ID: VKF-MWM2 Dear Sir or Madam, Masimo Corporation certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. We also certify that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. If you have any questions, please contact us. Sincerely, Contact name: Anamidevi Joshi Company name: Masimo Corporation Address: 52 Discovery, Irvine, CA 92618 E-mail: ajoshi@masimo.com Tel: 949-297-7663

Cover letter for FCC application Masimo Corporation is submitting the MWMII wifi module for FCC Class II permissive change approval. Rad-97 Homecare Rainbow (P/N: 26255-006) and Rad-97 Homecare NiBP (P/N: 26255-007) leverage MWMII Single modular approval with FCC ID: VKF-MWM2. Class II permissive change is filed for the change in RF exposure conditions from mobile at modular level to portable at host level. Please refer to datasheets accordingly. All Rad-97 variants support 802.11a, 802.11b, and 802.11g including 802.11n in the 2.4GHz and 5GHz bands along with BlueTooth Radio that supports up to and including 4.2+EDR and BlueTooth Low Energy. MWMII FCC modular approval was obtained with two antennas:

(1) Ethertronics p/n 9000129

(2) Ethertronics p/n 1000672 Rad-97 Homecare Rainbow, and Rad-97 Homecare NiBP uses antenna: Ethertronics p/n 9000129. MWMII has been tested to 47 CFR FCC 15.247 and 47 CFR FCC 15.407. Respectfully, Anamidevi Joshi EMC Project Manager Masimo Corporation

Date: 25 May 2023 Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request FCC ID: VKF-MWM2 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules, Masimo Corporation hereby requests permanent confidential treatment of information accompanying this application as outlined below:

Schematics Bill of Materials Block Diagrams Operational Description Frequency Block Diagrams The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Name: Anamidevi Joshi Title: EMC Project Manager

Cover letter for FCC application Masimo Corporation is submitting the MWMII wifi module for FCC Class II permissive change approval. Root and Root Vital Signs leverage MWMII Single modular approval with FCC ID: VKF-MWM2. Class II permissive change is filed for the change in RF exposure conditions from mobile at modular level to portable at host level. Please refer to datasheets accordingly. Root and Root Vital Signs support 802.11a, 802.11b, and 802.11g including 802.11n in the 2.4GHz and 5GHz bands along with BlueTooth Radio that supports up to and including 4.2+EDR and BlueTooth Low Energy. MWMII FCC modular approval was obtained with two antennas:

Root and Root Vital Signs uses antenna: Ethertronics p/n 1000672. MWMII has been tested to 47 CFR FCC 15.247 and 47 CFR FCC 15.407.

(1) Ethertronics p/n 9000129

(2) Ethertronics p/n 1000672 Respectfully, Anamidevi Joshi EMC Project Manager Masimo Corporation