User Manual
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| Document Description | User Manual |
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| Date Submitted | 2015-03-11 00:00:00 |
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| Document Author: | valbertson |
Root® Operator's Manual These operating instructions intend to provide the necessary information for proper operation of the Root®. There may be information provided in this manual that is not relevant for your system. Do not operate Root without completely reading and understanding these instructions. NOTICE: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. CAUTION: Federal law restricts this device to sale by or on the order of a physician. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Wireless Radio IC:7362A-RDS7A IC Model: RDS7A FCC ID: VFK-RDS7A Model - RDS7A www.masimo.com Masimo Masimo Corporation 40 Parker Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU authorized representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany Medical electrical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1 Patents: www.masimo.com/patents.htm © 2014 Masimo Corporation Root, SEDLine, Radical-7, rainbow, SET, Signal Extraction Technology, Masimo and , are federally registered trademarks of Masimo Corporation. MOC-9, Iris and ISA are trademarks of Masimo Corporation. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. All other trademarks and registered trademarks are property of their respective owners. www.masimo.com Masimo Contents About this Manual ----------------------------------------------------------------------------- 7 Product Description, Features and Intended Use ------------------------------------------ 9 Product Description and Features -------------------------------------------------------- 9 Intended Use -------------------------------------------------------------------------------- 9 Indications for Use ----------------------------------------------------------------------- 10 Safety Information, Warnings and Cautions --------------------------------------------- 13 Safety Warnings and Cautions ---------------------------------------------------------- 13 Performance Warnings and Cautions -------------------------------------------------- 14 Cleaning and Service Warnings and Cautions ---------------------------------------- 16 Compliance Warnings and Cautions --------------------------------------------------- 17 Chapter 1- Description ---------------------------------------------------------------------- 19 Features ------------------------------------------------------------------------------------ 19 Chapter 2- Setting Up ----------------------------------------------------------------------- 23 Unpacking and Inspection --------------------------------------------------------------- 23 Guidelines for Setting Up --------------------------------------------------------------- 23 Power On ---------------------------------------------------------------------------------- 24 Initial Battery Charging------------------------------------------------------------------ 25 Radical-7 Connection -------------------------------------------------------------------- 26 Nurse Call Connection ------------------------------------------------------------------- 26 Chapter 3- Operation ------------------------------------------------------------------------ 29 About the Status Bar --------------------------------------------------------------------- 29 About the Main Screen ------------------------------------------------------------------ 31 Using the Touchscreen Interface ------------------------------------------------------- 33 Menu Navigation ------------------------------------------------------------------------- 37 Understanding Windows ---------------------------------------------------------------- 38 Accessing Main Menu Options --------------------------------------------------------- 45 Alarm Interface --------------------------------------------------------------------------- 60 www.masimo.com Masimo Root Contents Trend Download ---------------------------------------------------------------------------63 Lights----------------------------------------------------------------------------------------64 Chapter 4- Radius-7 --------------------------------------------------------------------------66 Chapter 5- O3 Regional Oximetry----------------------------------------------------------67 Chapter 5- MOC-9 ----------------------------------------------------------------------------69 Using MOC-9 Ports -----------------------------------------------------------------------69 Chapter 7- Iris ---------------------------------------------------------------------------------71 Iris Status Screen --------------------------------------------------------------------------72 Using Iris Connectivity Ports ------------------------------------------------------------73 Chapter 8- Messages -------------------------------------------------------------------------75 Messages------------------------------------------------------------------------------------75 Chapter 9- Troubleshooting -----------------------------------------------------------------77 Troubleshooting Radical-7, Radius-7 and MOC-9 Modules ------------------------77 Troubleshooting Root ---------------------------------------------------------------------77 Chapter 10- Specifications-------------------------------------------------------------------81 Electrical ------------------------------------------------------------------------------------81 Environmental -----------------------------------------------------------------------------81 Display --------------------------------------------------------------------------------------82 Alarms --------------------------------------------------------------------------------------83 Nurse Call Specifications-----------------------------------------------------------------83 Connectors----------------------------------------------------------------------------------83 Wireless Specifications -------------------------------------------------------------------84 EMC Compliance -------------------------------------------------------------------------85 Software Compliance ---------------------------------------------------------------------86 Safety Standards Compliance ------------------------------------------------------------86 Guidance and Manufacturer's Declaration-Electromagnetic Emissions -----------87 Guidance and Manufacturer's Declaration-Electromagnetic Immunity ------------88 Recommended Separation Distances ---------------------------------------------------92 www.masimo.com Masimo Root Contents Symbols ------------------------------------------------------------------------------------ 94 Chapter 11- Service and Maintenance ---------------------------------------------------- 97 Cleaning ----------------------------------------------------------------------------------- 97 Replacing the Fuses ---------------------------------------------------------------------- 98 Power-On Self Test ---------------------------------------------------------------------- 98 Nurse Call Setting Connections -------------------------------------------------------- 98 Battery Test ------------------------------------------------------------------------------ 100 Repair Policy ----------------------------------------------------------------------------- 100 Return Procedure ------------------------------------------------------------------------ 101 Contacting Masimo --------------------------------------------------------------------- 101 Index ------------------------------------------------------------------------------------------ 105 Outside Back Cover ------------------------------------------------------------------------ 108 www.masimo.com Masimo About this Manual This manual explains how to set up and use Root. 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 instrument 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 Masimo Product Description, Features and Intended Use Product Description and Features Root is a patient monitoring and connectivity platform to transform care. It offers multiple high-impact innovations for broad applications across the continuum of care. Instantly interpretable, high-visibility display of Masimo’s breakthrough SET® and rainbow® SET measurements from Masimo's Radical-7® Pulse CO-Oximeter (Radical-7) and the Radius-7™ Wearable Pulse COOximeter (Radius-7). Intuitive, touchscreen navigation for easy and adaptable use in any hospital environment. Flexible measurement expansion through Masimo Open Connect (MOC9™). 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 monitors. Docking and charging station for Radical-7 and Radius-7 devices. For all prescribing information and instructions for use of the compatible medical devices that are connected to Root, see Operator’s 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. Root can transmit data for supplemental remote viewing and alarming (e.g., at a central station). Root can be used with the optional Radical 7, ISA product family and/or the SEDLine module. Root is intended to be used with connected measurement modules compatible with Root interfaces. www.masimo.com Masimo Root Product Description, Features and Intended Use 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 Masimo Root Monitoring System can transmit data 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 saturation of arterial hemoglobin (SpO2), pulse rate (PR), 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 ISA product family consists of three types of sidestream 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 ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane 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 and infant 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 Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR) and/or respiratory rate (RRa). The Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with www.masimo.com 10 Masimo Root Product Description, Features and Intended Use 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. www.masimo.com 11 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 of Patient Safety Net, Radical 7, Radius-7, ISA 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 the Root. Injury to personnel or equipment damage could occur. WARNING: Do not start or operate the Root unless the setup was verified to be correct. WARNING: To ensure safety, only use Masimo authorized devices with Root. WARNING: Explosion Hazard: Do not use the Root in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. WARNING: To reduce the risk of explosion, only replace battery with Masimo supplied parts. WARNING: Fire Hazard: To protect against fire hazard, replace only with fuses of same type, current rating, and voltage rating. WARNING: Do not use the Root during magnetic resonance imaging (MRI) or in an MRI environment. 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. www.masimo.com 13 Masimo Root Safety Information, Warnings and Cautions WARNING: Electrical Shock Hazard: Injury to personnel could occur. Do not plug in or remove the power cord with wet hands. 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: To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. WARNING: Do not place the Root or accessories in any position that might cause it to fall on the patient. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. CAUTION: Do not place the Root where the controls can be changed by the patient. CAUTION: To ensure patient isolation, connect only Masimo devices that have been designed for Root. 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 hospitalgrade 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 the 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. Performance Warnings and Cautions www.masimo.com 14 Masimo Root Safety Information, Warnings and Cautions WARNING: Root may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements. WARNING: Root may be used during electrocautery, but 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. CAUTION: Ensure the speaker is not covered. 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 instrument, preventing it from working properly. CAUTION: Failure to charge Root promptly after a Low Battery alarm may result in the instrument 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 Root’s minimum Quality of Service, the following network specifications should be met before and after installation: Wired Network Connection During Ping Test, passing result if: a. At least 98% of packets have latency ≤ 30 milliseconds, and b. No more than 2 % packets loss. Wireless Network Connection During Ping Test, passing result if: 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. 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 www.masimo.com 15 Masimo Root Safety Information, Warnings and Cautions 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: The wireless communication status between Root and Patient SafetyNet is displayed by Patient SafetyNet. Note:Root is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Root’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Root’s primary alarms. Note: Always charge Root when it is not in use to ensure that the battery remains fully charged. 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 device’s materials and instrument 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: Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any AC power source. 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. www.masimo.com 16 Masimo Root Safety Information, Warnings and Cautions 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. 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. CAUTION: Consideration to the compliance of the IEC 60601-1 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 instrument and/or its accessories. Note: Use Root in accordance with the Environmental Specifications section in the Operator's Manual. 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 instructions for use or labeling. Note: 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. 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 in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, 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 17 Masimo Root 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 colocated 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 all establishments, including domestic establishments. Note: This Class A digital apparatus complies with Canadian ICES-003. Note: Root is not intended for use during patient transport outside the healthcare facility. www.masimo.com 18 Masimo Chapter 1- Description Root can be used in the following ways: As a docking station and charger for Radical-7 and Radius-7. As a bedside monitoring display for parameters on Radical-7, Radius-7 and MOC-9 modules. As a connectivity gateway for standalone devices. Features Front View Ref. Feature Description Provides a docking station for the Radical-7 and Radius-7 (Note: Battery Charging Adapter required for Radius-7). Docking Station While docked, the Radical-7 can communicate monitored parameters and measurements.* Root Display and Touchscreen Provides an interface for user interactions. Home Button Provides access to the Main Screen. www.masimo.com 19 Masimo Root Chapter 1- Description Ref. Feature Description Root Charging Indicator Shows an indication of the battery charge for Root. AC Power Indicator Shows an indication of AC power connection Root. Radical-7 Charging Indicator 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. Back View Feature 1 Handle www.masimo.com Description Allows the user to transport Root. 20 Masimo Root Feature 2 Speaker Nurse Call Connector Chapter 1- Description Description Provides audible notification. Provides a connection to a Nurse Call system. 4 Ethernet Port Provides a network connection to Root using an RJ-45 cable. 5 USB Ports (2) Provide USB 2.0 connectivity. Power Entry Module Provides optional functional earthing for Root to eliminate Equipotential potential differences. The use of the Equipotential Ground Ground Connector Connector should be in accordance with IEC 60601-1. Iris Connectivity Ports (4) www.masimo.com Contains the input connector for a hospital grade AC power cord and the fuse holder. Provide connection for standalone devices. 21 Masimo Root Chapter 1- Description Side Views Right side Left side Feature Description System Status Lights Provides an indication of alarms and system messages. See System Status Lights. 2 Power Button Places Root in Power On, Standby and Power Off modes. 3 MOC-9 Ports (3) Provide connectivity for MOC-9 modules. www.masimo.com 22 Masimo Chapter 2- Setting Up Unpacking and Inspection To unpack and inspect Root 1. 2. 3. Remove Root from the shipping carton and examine it for signs of shipping damage or exposed electronics. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. Confirm that you have all components for the Root: Root AC Power Cord If anything is missing or damaged, contact Masimo's Technical Service Department. See Return Procedure. 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 space around Root. Ensure that the back panel Speaker is not covered to avoid a muffled alarm sound. Charge Root's battery fully before use. See Initial Battery Charging. Root should not be operated outside the environmental conditions listed in the specifications section. See Environmental Specifications. www.masimo.com 23 Masimo Root Chapter 2- Setting Up Power On The Power Button can be used for Power On, Standby, and Power Off. To Power On, press the Power Button for two (2) seconds until a single audible tone sounds. 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 24 Masimo Root Chapter 2- Setting Up For information about Standby Mode and Power Off, See Standby and Power Off. 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 and About the Status Bar. (1) (2) 4. The Root Charging Indicator remains orange while the battery is charging and will illuminate green when Root is fully charged. See Root Battery and About the Status Bar. See Safety Informations, Warnings and Cautions. www.masimo.com 25 Masimo Root Chapter 2- Setting Up Radical-7 Connection It is recommended that Root be powered on before performing the steps below. Snap the Radical-7 into the Docking Station. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to power it on. When properly connected, the Radical-7 Charging Indicator light will illuminate. An illuminated Radical-7 Battery icon will also appear in the Status Bar. Root display will show active measurements and parameters. For Radical-7 charging conditions, see Radical-7 Charging Indicator. Nurse Call Connection Use a Nurse Call connection cable to connect to a Nurse Call System. www.masimo.com 26 Masimo Root Chapter 2- Setting Up To connect to a Nurse Call System 1. 2. 3. 4. Identify the Nurse Call connection end (1/4 inch round female connector) of the cable. Insert the Nurse Call connection cable securely into the compatible port on Root. 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. For more information, see Device Output. www.masimo.com 27 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. 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 Alarm Silence Audio Pause Profiles Description Displays alarm status and mutes all audible alarms for Root, Radical-7, Radius-7 and MOC-9 modules. See Alarm Silence. Displays Audio Pause status and temporarily silences an alarm event. See Audio Pause. Provides access to the Profiles screen. The example shown illustrates that Profiles is currently set to Adult for an adult patient. See Profiles. Bluetooth Provides access to the Bluetooth screen. If this icon is visible, then Bluetooth connectivity has been enabled. See Bluetooth. www.masimo.com 29 Masimo Root Chapter 3- Operation Ref. Feature Wi-Fi Description Provides access to the Wi-Fi screen. If this icon is visible, then Wi-Fi connectivity has been enabled. The icon itself also indicates the strength of the wireless signal. See Wi-Fi. Ethernet Provides access to the Ethernet screen. If this icon is visible, then Ethernet connectivity has been enabled. See Ethernet Iris Provides access to the Iris screen. The example shown above indicates that standalone devices are connected to Ports 1, 2 and 3 and the information is being sent to Patient SafetyNet or Connectivity Gateway. The color of the icon matches the status colors of connected standalone devices on the Iris screen. See Iris. Radical-7 Battery Displays charging status for Radical-7 and provides access to the Battery Radical screen. The example shows that the battery is currently charging. See Radical-7 Charging Indicator. Root Battery Displays charging status for Root and provides access to the Battery Root screen. The example shows that the battery is currently charging. See Root Charging Indicator. 10 Sounds Provides access to the Sounds screen to adjust alarm and pulse tone volume. This icon does not indicate the actual volume level of the alarm and pulse tone. See Sounds. 11 Current Time Displays the current time and provides access to the Localization screen which contains settings related to local time, language and geography. See Localization. www.masimo.com 30 Masimo Root Chapter 3- Operation About the Main Screen The Main Screen consists of several features. The following shows the Main Screen when three different devices are connected, Radical-7 (top) showing rainbow® parameters and measurements, Phasein module (middle) showing capnography measurements and SedLine module (bottom) showing brain function measurements. Ref. Feature Description Status Bar Displays system status as well as icons that provide shortcuts to menu items or actions. See About the Status Bar. Windows Provides a dynamic, user-configurable display area for all the data from connected medical devices. www.masimo.com 31 Masimo Root Chapter 3- Operation Ref. Feature Main Menu icon www.masimo.com Description Provides access to the configuration options for Root and connected medical devices. See Accessing Main Menu Options 32 Masimo Root Chapter 3- Operation Using the Touchscreen Interface Using the gestures described below, the user is able to customize the viewing experience, including displaying the highest priority parameters and measurements. The availability of navigation features is dependent on the connected medical devices. Action Illustration Example Description Press Touch and release. Action performed once finger is released. Slide Touch, move (left, right, up or down), and release. Moves an object across the display. Swipe Touch, move (left, right, up or down), and release quickly. Pinch Touch, move, and release via two touch points. Moving touch points apart zooms in, and moving them together zooms out. Drag and Drop See Customizing Windows. Touch, hold, drag an object to desired position, and drop it by releasing. 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 www.masimo.com Switches between toggle states 33 Masimo Root Control Labeled Toggle Spinner Slider Slider Spinner Chapter 3- Operation Applicable Actions Description Press left or right of toggle Quickly moves knob left or right Slide knob Switches between toggle states Press left or right of toggle Quickly moves knob left or right Press label Quickly moves knob left or right Press center (focused) tile When closed, expands the spinner 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 outside spinner When open, collapses spinner Slide knob Moves knob Press anywhere along slider path Quickly moves knob to Tap position Slide knob Moves knob Press anywhere along slider path Quickly moves knob to Tap position Press center (focused) tile When closed, expands the spinner When open, collapses the spinner Swipe up/down When open, scrolls through spinner tiles Press unfocused tile When open, scrolls tile into center (focused) www.masimo.com 34 Masimo Root Control Chapter 3- Operation Applicable Actions Description position Press anywhere outside spinner When open, collapses spinner Button Press Performs action (as defined by the button description) Icon Menu Press tile Opens menu specified by tile Swipe left or right (anywhere) Scrolls icons left or right Press bottom indicator icon Quickly centers tile corresponding to indicator icon Press parameter or measurement When no parameter or 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 Press parameter or measurement When no parameter or 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 Swipe down Separates pleth and acoustic waveforms Window Well Live www.masimo.com 35 Masimo Root Control Chapter 3- Operation Applicable Actions Description Swipe up Combines pleth and acoustic waveforms Pinch in Zooms in Pinch out Zooms out Pan Changes time range Press y-axis Opens parameter or measurement trend menu Press '+' Increases time range Press '-' Decreases time range Press time label Resets time range to default Alarm Silence icon Press Silences all alarms Audio Pause icon Press Enables Audio Pause Other Status Bar icons Press Opens relevant menu Back Arrow Press Exits menu, abandons any changes Waveform Trend Line Trend Zoom www.masimo.com 36 Masimo Root 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 37 Masimo Root Chapter 3- Operation Understanding Windows 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 instructions for use or Operator's Manual of Radical-7, Radius-7 and MOC-9 modules. Trend View Analog View Feature Description Window The area where all data from a docked Radical-7, Radius-7 or connected MOC-9 module are displayed. Drop Down Settings Menu Waveform Shows a parameter or measurement over time (only for Radical7, Radius-7 and MOC-9 modules). www.masimo.com 38 Masimo Root Chapter 3- Operation Feature Description Trend Display (Available only in Trend View) Parameters and 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. Using Trend View. 4b Analog Gauge (Available only in Analog View) Parameters and measurements are shown as Analog Gauges in Analog View. A parameter's Analog Gauge includes its Alarm Limits, Numeric Value, Parameter Label, as well as Alarming, Caution and Normal Ranges. See Using Analog View. Well Displays parameters and measurements which are not shown as Trend Displays or Analog Gauges. 4a Using Trend View In Trend View, a parameter or measurement is displayed as a graph of its values (Trend View icon) displays over time. If a Window supports Trend View, then in the upper right corner. Press the icon to view parameter or measurement data in Trend View. The following diagram and table describe key features of a parameter's Trend Display in Trend View. Feature 1 Value Range www.masimo.com Description 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. 39 Masimo Root Feature Chapter 3- Operation Description 2 Trend Line Displays parameter and measurement over a period of time. Zoom in and out of a Trend Line by pinching out and in. 3 Numeric Value Indicates current reading of the parameter or measurement. 4 Alarm Limits Indicate high and low alarm limits for the parameter or measurement, if supported. Parameter or Indicates the name of the parameter or measurement. Measurement Label www.masimo.com 40 Masimo Root Chapter 3- Operation Using Analog View 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 instructions for use or operator's manuals for Radical-7,Radius-7 and the appropriate MOC-9 module(s). If a Window supports Analog View, then (Analog View icon) displays in the upper right corner. Press the icon to view parameter and measurement data in Analog View. 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 Needle Indicates current status of a parameter or measurement. Alarm Limits Indicate high and low alarm limits for the parameter or measurement. Numeric Value Indicates current reading of the parameter or measurement www.masimo.com 41 Masimo Root Chapter 3- Operation Ref. Feature Parameter or Measurement Label www.masimo.com Description Indicates the name of the parameter or measurement. 42 Masimo Root Chapter 3- Operation Specific ranges of the Analog View are: Ref. Feature Color Description Normal Range White Area of the display range where an alarm will not be triggered. Caution Range Yellow Area of the display range that provides a caution indicator. Alarming Range Area of the display range where an alarm will be triggered. Red 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. Quarter Circle www.masimo.com Half Circle 43 Masimo Root Chapter 3- Operation Customizing Windows 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. Step 3 Release the Numeric Value. www.masimo.com 44 Masimo Root Chapter 3- Operation 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. Accessing Main Menu Options To access the Main Menu options At the bottom right corner of the touchscreen, press the Main Menu icon. www.masimo.com 45 Masimo Root Chapter 3- Operation The Main Menu options are: Device Settings See Device Settings. About See About. Trend Settings See Trend Settings. Profiles See Profiles. Iris See Iris. Layout See Layout. Sounds See Sounds. Device Settings www.masimo.com 46 Masimo Root Chapter 3- Operation The Device Settings menu allows the user to view and customize settings for Root. The Device Settings options are: Localization See Localization. Wi-Fi See Wi-Fi Ethernet See Ethernet. Bluetooth See Bluetooth. Root Battery See Root Battery Radical-7 Battery See Radical-7 Battery. Brightness See Brightness. Access Control See Access Control. Device Output See Device Output www.masimo.com 47 Masimo Root Chapter 3- Operation 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. Option Description Factory Default Configurable Setting Settings Language Selects the language display for Root. Date Format Sets the display format for mm/dd/yy current date. mm/dd/yy or Time Sets the display format for 12 hour current time. 12 hour or Line Frequency Sets to match regional power line frequency. 60 Hz 50 Hz or 60 Hz Date Sets the current date. N/A N/A Time Sets the current time. N/A N/A English Choose from available languages. dd/mm/yy 24 hour Wi-Fi The Wi-Fi radio allows for networked communication of data and alarm signals between Root and a secondary patient monitoring station, Masimo’s Patient SafetyNet over an IEEE 802.11 a/b/g wireless network. The wireless data www.masimo.com 48 Masimo Root Chapter 3- Operation transmission is an optional network data transmission to the wired network data transmission, using Root’s integral Ethernet Port. 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, Root’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Root’s 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. Option Description Wi-Fi Enables or disables Wi-Fi connectivity. Factory Default Setting Configurable Settings 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 on Patient SafetyNet, see Operator's Manuals of Patient SafetyNet. Ethernet www.masimo.com 49 Masimo Root Chapter 3- Operation 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. Option Description Ethernet Enables or disables Ethernet connectivity. Factory Default Setting Configurable Settings 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 Masimo’s MyView Presence Tag. Root’s detection of Masimo’s 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 Option Bluetooth Description Enables or disables Bluetooth connectivity. Factory Default Setting Configurable Settings Off On or Off For more information on how to configure Masimo MyView Presence Tag, see Operator's Manual of Patient SafetyNet. www.masimo.com 50 Masimo Root Chapter 3- Operation 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. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Diagnostics Allows trained personnel to access battery diagnostic information. Radical-7 Battery Use the Battery screen to view the specific percentage of charge on the Radical-7's battery. The user can also access the Battery screen by pressing the Radical-7's Battery icon on the Status Bar. See About the Status Bar. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Diagnostics Allows trained personnel to access battery diagnostic information www.masimo.com 51 Masimo Root Chapter 3- Operation Brightness Use the Brightness screen to adjust the brightness of the Root display. Option Description Factory Default Setting Configurable Settings Auto Brightness Allows automatic adjustment of Root's display brightness based on ambient light. Off On or Off Brightness Adjust the brightness level of the Root display by sliding the button (4 is brightest). 1, 2, 3, 4 Access Control Access Control contains configurable options and settings that require a password. To enter Access Control www.masimo.com 52 Masimo Root 1. 2. 3. Chapter 3- Operation key. Press the When the numeric screen displays, enter the following numbers: 6 2 7 4 Asterisks (****) will be displayed. To undo an entry, press Backspace. 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 Default Setting Configurable Settings All Mute Enabled Enable parameter Alarm Silence menu option. See Sounds. Off On or Off Lock Alarm Volume Sets the lowest alarm volume level. Off 3, 4, or Off Save as Adult Saves current profile parameter as the Adult Profile. N/A Press Save to load. Save as Pediatric Saves current profile parameter as the Pediatric Profile. N/A Press Save to load. Save as Neo Saves current profile parameter as the Neonatal Profile. N/A Press Save to load. Factory Defaults Options are restored to factory values. N/A Press Restore. Device Output www.masimo.com 53 Masimo Root Chapter 3- Operation 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 Default Setting Configurable Settings Nurse Call Polarity Controls the mechanism of action for triggering to occur. Should be changed to Normal accommodate institutional Nurse Call settings. Normal or Inverted Nurse Call Trigger Controls the source of monitoring which sets off the trigger. Alarms Alarms, Signal IQ Alarms, and Signal IQ Port 0 None None, IAP, IntelliBridge, and ASCII 1 Port 1 IAP None, IAP, IntelliBridge, and ASCII 1 SpecTable Radical Radical, Radical Module A, Sedline, and Sedline Numerics Only 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. www.masimo.com 54 Masimo Root Chapter 3- Operation About 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. 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. Information about Radical-7, Radius-7 and MOC-7 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 Default Duration Duration captured by Trend Lines. 2 hours Clear Trends Delete all stored trend data. N/A www.masimo.com Factory Configurable Settings Default Setting 55 15, 30, 45 minutes 1, 2, 4, 8, 12, 24 hours Press Clear to delete all stored trend data. Masimo Root Chapter 3- Operation To configure trend settings of specific parameters and measurements, see Instructions for Use or Operator's Manuals for Radical-7,Radius-7 and appropriate MOC-9 module(s). Profiles Use the Profiles screen to select patient type. Option Description Patient Type Identifies the Profiles setting in the device. Factory Default Setting Configurable Settings 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 settings on Root. The settings of the three default profiles (Adult, Pediatric, and Neonatal) configure parameter alarms, averaging time, and sensitivity modes. Custom profiles can also be created to accommodate usage in any hospital care area. See the Masimo Instrument Configuration Tool Directions for Use for information on adding Profiles. For more information regarding Profiles, see the Instructions for Use or Operator’s Manuals for Radical-7,Radius-7 and appropriate MOC-9 module(s). Iris 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 Status Screen. www.masimo.com 56 Masimo Root Chapter 3- Operation Layout Use the Layout screen to select sizing options for Windows and Trend Displays. Additional Settings There are different ways to display the parameters and measurements by changing the Layout Style. Note: This feature only applies to Trend View. See Using Trend View. Option Layout Style Description Controls the sizing of Trend Displays. Factory Default Setting Configurable Settings Fixed Fixed or Dynamic The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View. www.masimo.com 57 Masimo Root Chapter 3- Operation Fixed Ref. Description 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. Size of each Trend Display is fixed. Dynamic Ref. Description 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. *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. Available Layout When only Radical-7,Radius-7 or a single MOC-9 module is connected to Root, the Available Layout will be 100%. When Radical-7 and/or multiple devices are connected, the user will have the option to select from several pre-configured layouts. www.masimo.com 58 Masimo Root Chapter 3- Operation Sounds Use the Sounds screen to control the volume level of sounds and duration of audio pause for Root. Option Description Factory Default Setting Configurable Settings Alarm Volume Sets the alarm volume level. Highest volume Slide towards the left to decrease volume to silence. Pulse Tone Volume Sets the pulse tone volume Highest level. volume Slide towards the left to decrease volume to silence. 1, 2, 3 minutes, Permanent*, Permanent with Reminder*. Audio Pause Duration Sets the length of time that the audible alarm remains silenced, when Audio 2 minutes Pause is enabled. See Audio Pause. If Permanent is selected, there will be no audible alarms, but visual alarms will still display. If Permanent with Reminder is selected, a tone will sound every three (3) minutes as a reminder that Permanent is active. *Requires user to have All Mute Enabled (Permanent Silence Duration) in the Access Control menu. See Access Control. www.masimo.com 59 Masimo Root Chapter 3- Operation Alarm Interface Alarms can have different priority levels and come from different sources. The following tables describe alarm behaviors in more detail. Priority Alarm Sound Five (5) beeps: beep-beep-beep, brief pause, beep-beep Three (3) beeps: beep-beep-beep Alarm Source Example Explanation Parameter Level www.masimo.com The example shown here is a PR alarm as the reading (142) exceeds the upper alarm limit (140). Note that 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 (High PR > 140). 60 Masimo Root Alarm Source Chapter 3- Operation Example Explanation The example shown here is a "High Impedance" alarm in the lower Window. Window Level Note that 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 that the border of the entire Root display is illuminated red, and the explanation of the alarm is shown in the Status Bar (Low Battery). System Level For more details about specific alarms on Radical-7,Radius-7 and MOC-9 modules, see Instructions for Use or Operator’s Manuals for Radical-7,Radius-7 and MOC-9 modules. www.masimo.com 61 Masimo Root Chapter 3- Operation 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 Operator’s Manuals for Radical-7, Radius-7 and appropriate MOC-9 module(s). Icon Appearance Description Visual Alarms There are currently no active alarms, and no alarms have been silenced. No There are currently no active alarms, but at least one alarm has been and is still silenced. No There is currently at least one active alarm that has not been silenced. Yes There is currently at least one active alarm, but all active alarms are silenced. Yes www.masimo.com 62 Masimo Root Chapter 3- Operation Audio Pause 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. 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 117 seconds left until Audio Pause is inactivated again. To configure Audio Pause, see Sounds. Audio Pause active. 117 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. 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 63 Masimo Root Chapter 3- Operation 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 System Status Light Light Status Alarm Priority Indication None None Monitoring has not begun. Green None There is currently no active alarms. Yellow Low There is an active alarm of low priority. 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 Low Service required High AC Power Indicator www.masimo.com 64 Masimo Root Chapter 3- Operation Whenever Root is connected to an AC power source, this light will illuminate: Light Status Indication Green Root is connected to an AC power source. Off Root is not connected to an AC power source. Root Charging Indicator Whenever Root is connected to an AC power source, if not fully charged, its battery will charge. Light Status Battery Indication Green Battery is fully charged. Orange Battery is charging. Red Battery charging error. Off Battery is not being charged. Root is not connected to AC power source. www.masimo.com 65 Masimo Root Chapter 4- Radius-7 Standby and Power Off To put Root in the Standby Mode or Power Off Mode, follow these steps: State Standby Mode Power Off Mode Description Press and hold the Power Button for two (2) seconds until one (1) audible tone sounds. Standby Mode conserves power while enabling a quicker startup sequence. Press and hold the Power Button for eight (8) seconds, until two (2) audible tones sound. The Home Button will flash, and the Power Button will flash orange. Power Off Mode completely shuts down Root and results in a longer startup sequence. Chapter 4- 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 Acoustic Respiration Rate (RRa®). It uses a Bluetooth or Wi-Fi connection to transfer parameter data to Root. When Radius-7 is connected to Root via Bluetooth or Wi-Fi, the device automatically creates a Window that displays all the data from Radius-7. 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 more information. www.masimo.com 66 Masimo Root Chapter 5- O3 Regional Oximetry Chapter 5- O3 Regional Oximetry The O3 system is a patient-connected, noninvasive oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation in the tissue (rSO2), including cerebral tissue. It can be used in any hospital and hospitaltype facility where rSO2 measurements might improve patient outcomes. The Masimo O3 Regional Oximeter and Sensors are indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue below the sensor in hospital and hospital-type facilities. See the O3 Operator's Manual for more information. www.masimo.com 67 Masimo Chapter 5- MOC-9 Flexible measurement expansion is enabled through MOC-9. It can display parameters and measurements captured by 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 Phasein capnography MOC-9 modules that are connected to Root. Using MOC-9 Ports Use a MOC-9 cable to connect other MOC-9 modules to Root. To use an MOC-9 Port 1. 2. 3. Identify the MOC-9 end of the cable. Orient the cable to fit correctly into an MOC-9 Port. Insert the MOC-9 cable securely into any of the three (3) compatible ports on Root. www.masimo.com 69 Masimo Chapter 7- 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. Ref. Description 1 - 4 Standalone devices connected via Iris (e.g., monitor, pump, ventilator) Root Radical-7 MOC-9 modules Patient SafetyNet or Masimo Connectivity Gateway Electronic Health Records system www.masimo.com 71 Masimo Root Chapter 7- Iris Iris Status Screen Information about Iris Connectivity Ports are displayed on this screen, which is accessible by selecting the Iris option on the Main Menu. Connection Status Color Description of Connection Green Standalone device is successfully connected to Root, and Root is successfully connected to a Patient SafetyNet or Connectivity Gateway. Yellow Standalone device is successfully connected to Root; however, Root is not successfully connected to a Patient SafetyNet or Connectivity Gateway. Gray No standalone device is connected to the Iris Connectivity Port. Additionally, the Ports are also mapped to the Iris icon on the Status Bar. When a standalone device is connected to Root via one of the Ports, the corresponding part of the icon will be lit green or yellow. In the example below, a standalone device is connected to Iris Connectivity Port 1. Port 1 (connected) www.masimo.com Port 2 72 Masimo Root Chapter 7- Iris Port 3 Port 4 Status and connection type are read-only and not configurable by the user. For more information on Iris connectivity, see Instructions for Use or Operator’s Manual for the appropriate version of Masimo Patient SafetyNet. Using Iris Connectivity Ports Use Iris Adapters and RJ-45 cables to connect standalone devices to Root. Port 1 Port 2 Port 3 Port 4 To connect a standalone device via an Iris Connectivity Port: 1. 2. Connect the RS-232 end of the Iris Adapter to the standalone device. 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 73 Masimo Chapter 8- Messages 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. A MOC-9 module is disconnected from Root. Reconnect module or acknowledge message by pressing the Alarm Silence icon. Radical-7 Disconnected Radical-7 is disconnected from Root. Reconnect Radical-7 or acknowledge message by pressing the Alarm Silence icon. Radius-7 Disconnected Reconnect Radius-7 or Radius-7 is disconnected from acknowledge message by Root pressing the Alarm Silence icon. MOC-9 module disconnected (e.g. SedLine Disconnected) For additional messages, see Instructions for Use or Operator's Manuals for Radical7, Radius-7 and MOC-9 modules. www.masimo.com 75 Masimo Chapter 9- Troubleshooting Troubleshooting Radical-7, Radius-7 and MOC-9 Modules For information on troubleshooting values that are provided from Radical-7, Radius7 and MOC-9 modules refer to their respective Instructions for Use or Operator's Manuals. Troubleshooting Root Symptom Root does not turn on. Possible Cause Correction Power Button not pressed long enough. Press Power Button for two (2) seconds. The battery may be depleted. Connect Root to AC power to charge battery. One of the fuses is Replace the fuse. See Replacing the not operating Fuses. properly. Root turns on, but Main Screen is dim or blank. The brightness setting is not correct. Touch functionality is not responsive Internal Failure Not displaying data from Radical-7, Connection error. Radius-7 or MOC-9 modules. www.masimo.com Adjust the brightness setting. See Brightness. If the condition persists, Root requires service. Contact Masimo Technical Support. See Return Procedure. Root requires service. Contact Masimo Technical Support. See Return Procedure. Ensure that the connections are securely in place and properly plugged in, or that the cable is not defective. For Radius-7, ensure that the device is paired with Root via Wi-Fi or Bluetooth. Refer to Operator's Manual of Radius-7 for more information. 77 Masimo Root Symptom Chapter 9- Troubleshooting Possible Cause Correction Iris screen does not display connection Connection error status for standalone devices. Unplug and replug the Iris Adapter. Iris screen does not display connection Connection error. status for standalone devices. 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 operator’s manual for the appropriate version of Patient SafetyNet. Root has a continuous speaker tone. 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. Power Button does not respond when pressed. Internal failure. To Power On when turned off or in Standby Mode, press Power Button for Power Button may two (2) seconds. need to be pressed for a longer time. To Power Off when turned on or in Standby Mode, press the Power Button for eight (8) seconds. Internal failure. Root requires service. See Return Procedure. Home Button does not work when pressed. Internal failure. Root requires service. See Return Procedure. Battery does not charge. AC power cable may be disconnected. Unplug and replug AC power cable. Root Charging Indicator illuminates Internal failure. red. www.masimo.com Root requires service. See Return Procedure. 78 Masimo Root Chapter 9- Troubleshooting Symptom Possible Cause Nurse Call does not communicate. Connection error www.masimo.com Correction Unplug and replug Nurse Call connector. See Nurse Call Setting Connections 79 Masimo Chapter 10- Specifications This chapter contains specifications of Root. For information on the specifications of Radical-7, Radius-7, MOC-9 modules, and standalone devices, see Instructions for Use or Operator's Manuals for these devices. Electrical Root AC Power requirements 100-240 VAC~, 47-63 Hz, 65 W (Max) Fuses (2) 2 Amp, Fast Acting, Metric, (5x20mm), 250V, 1500A Breaking Capacity Battery Type 10.8V Lithium Ion (Nominal) Capacity 4 hours* Maximum Charging Time 4 hours *This represents approximate run time at the lowest brightness, using a fully charged battery. Environmental Root Operating Temperature 32°F to 122°F (0°C to 50°C) Transport/Storage Temperature -40°F to 158°F (-40°C to 70°C) Operating Humidity www.masimo.com 10% to 95%, non-condensing 81 Masimo Root Chapter 10- Specifications Root Storage Humidity 10% to 95%, non-condensing 500 mbar to 1060 mbar Operating Altitude -1000 ft to 18,000 ft (-304 m to 5,486 m) 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 Characteristic Description Type Multi-Touch P-Cap www.masimo.com 82 Masimo Root Chapter 10- Specifications Alarms Visual Alarm Priority System Status Light Color High Red Low Yellow Nurse Call Specifications The Nurse Call relays have the following electrical specifications per switch: Parameter Specification Max Voltage 36 VDC or 24 VAC peak Connectors Connector Type Ethernet Number of Ports 10/100 MBps Nurse Call 1/4 inch round female MOC-9 Masimo Connector USB USB 2.0 Iris RS-232/RJ-45 www.masimo.com 83 Masimo Root Chapter 10- Specifications Wireless Specifications Communication (Wi-Fi) Type Frequency WLAN Radio: IEEE 802.11 a/b/g 802.11a: 5180-5240 MHz, 5745-5825 MHz 802.11b/g: 2412-2462 MHz Max Peak Output Power WLAN 17 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types OFDM, BPSK, CCK Modulation Signals Analog and Digital 802.11a - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. Available Data Rates 802.11b - 1, 2, 5.5, 11 Mbps. 802.11g - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. Communication (Bluetooth) Type Bluetooth Frequency 2402-2480 MHz Max Peak Output Power Bluetooth 1.3 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types DH5 www.masimo.com 84 Masimo Root Chapter 10- Specifications Communication (Wi-Fi) Modulation Signals Analog and Digital Available Data Rates Bluetooth 1 Mbps Security and Authentication Encryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2AES Authentication Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST Radio Compliance USA FCC ID: VKF-RDS7A Model - RDS7A Canada IC:7362A-RDS7 IC Model: RDS7A RSS-210 Europe EN 300 328 EN 301 489-17 R & TTE Directive EMC Compliance EMC Compliance EN 60601-1-2, Class A device www.masimo.com 85 Masimo Root Chapter 10- Specifications Software Compliance Software Compliance EN 60601-1-4:1996 + A1: 1999 Safety Standards Compliance Protection from Ingress of Liquids IPX1 per IEC 60529 Electrical and Mechanical Safety UL 60601-1:2003 CAN/CSA 22.2 No. 601.1:2005 IEC 60601-1 / UL 60601-1: 1988 + A1: 1991 + A2:1995 EN 60601-1: 1990 + AI: 1993 + A2:1995 ISO 9919:2005 IEC-60601-2 - 49:2001 Type of Protection Class I (on AC power) Internally powered (on battery power) www.masimo.com 86 Masimo Root Chapter 10- 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 RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions Group 1 Class A Class A For hospital environment only. Not intended for use in a domestic environment. IEC 61000-3-2 Voltage Fluctuations / Flicker Emissions ME Equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Complies IEC 61000-3-3 www.masimo.com 87 Masimo Root Chapter 10- 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 Test Level Compliance Electromagnetic Environment Level Guidance Electrostatic discharge (ESD) +6 kV contact +6 kV contact IEC 61000-4-2 +8 kV air +8 kV air Electrical fast transient/burst +2 kV for power supply lines. -- Mains power quality should be that of a typical commercial or hospital environment. -- Mains power quality should be that of a typical hospital environment. IEC 61000-4-4 Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. +1 kV for input/output lines. Surge IEC 61000-4-5 +1 kV differential mode +2 kV common mode www.masimo.com 88 Masimo Root Chapter 10- Specifications Voltage dips, short interruptions and voltage variations on power supply input lines. 100% for 0.5 -cycle IEC 61000-4-11 30% for 25 cycles Mains power quality should be that of a typical commercial or hospital environment. Root provides a battery for continued operation during power mains interruption for a maximum of 4 hours. 60% for 5 cycles 100% for 5 seconds Power frequency (50 / 60 Hz) magnetic field. 3 A/m 3 A/m Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz IEC 61000-4-8 www.masimo.com 89 Power frequency magnetic fields should be at levels characteristic of typical location in a typical hospital environment. Masimo Root Chapter 10- Specifications Radiated RF 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz 3 V/m 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 to the frequency of the transmitter. Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2,5 GHz 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 survey, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: www.masimo.com 90 Masimo Root Chapter 10- Specifications 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. 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. www.masimo.com 91 Masimo Root Chapter 10- Specifications 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. Rated maximum output power of transmitter (W) Separation Distance According to Frequency of Transmitter (m) 150 K Hz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz d = 1.17*Sqrt (P) d = 1.17*Sqrt (P) d = 2.33*Sqrt (P) 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1.17 1.17 2.33 10 3.7 3.7 7.37 100 11.7 11.7 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 92 Masimo Root www.masimo.com Chapter 10- Specifications 93 Masimo Root Chapter 10- Specifications Symbols The following symbols are found on Root or its packaging and are defined below. Some of the interfaces and symbols are not available on all versions. Symbols Definition Symbols Definition Separate Collection for Electronic Waste Follow Instructions for Use Storage Temperature Limitation Manufacturer Storage Altitude Limitation Date of Manufacture Storage Humidity Limitation Non-ionizing Electromagnetic Radiation Keep Dry IPX1 Protection Against Liquid Drops Falling Vertically Fragile/Breakable, Handle with Care Federal (USA) Law Restricts this Device to Sale by Or on the Order of a Physician Fuse Replacement. See Replacing the Fuses section of the Operator's Manual. UL, LLC, Certification Equipotential Ground Terminal Federal Communications Commission (FCC) licensing Iris Connection www.masimo.com 94 Masimo Root Chapter 10- Specifications Symbols Definition Symbols Definition FCC ID, IC, IC Model Identifies Unit has been Registered as a Radio Device USB port Mark of Conformity to European Medical Device Directive 93/42/EEC AC Current Authorized representative in the European community Nurse Call Interface Wireless Features Can be Used in Member States with the restriction of indoor use in France Defibrillation Proof Type BF www.masimo.com 95 Masimo Chapter 11- 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 solvents: 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. www.masimo.com 97 Masimo Root Chapter 11- Service and Maintenance 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 fast-acting, 250V, 2 amp, metric, 5x20 mm and with a breaking capacity of minimum 1500A. 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 screwdriver. To replace the fuse(s) 1. 2. 3. 4. 5. 6. 7. Power Off Root completely. Do not put in Standby Mode. See Standby and Power Off. Remove the AC power cord from the Power Entry Module in the back panel. Remove the fuse holder by pulling it forward from the Power Entry Module. 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 not force. Place a new fuse in the fuse holder. If replacing both fuses, repeat steps 4 and 5 for the second fuse. 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. Power-On Self Test To conduct a Power-On Self Test 1. 2. Connect Root to AC power, and verify that the AC Power Indicator is illuminated. Power On Root. Within five (5) seconds, all available indicators will illuminate, the device will emit a tone, and the Masimo logo will display. 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 disconnected. In addition, the www.masimo.com 98 Masimo Root Chapter 11- Service and Maintenance Nurse Call Polarity can be inverted to accommodate various nurse call station requirements. Only qualified personnel should connect one of these two signals to a hospital’s Nurse Call system. Cable Description Nurse Call Event Menu Setting 2 contacts normally opened Nurse Call Polarity Normal Nurse Call 2 contacts normally closed Polarity Inverse 1 and 2 contacts normally opened Nurse Call 2 and 3 contacts normally closed Polarity Normal 1 and 2 contacts normally closed Nurse Call 2 and 3 contacts normally opened Polarity Inverse 1 and 2 contacts normally closed Nurse Call 2 and 3 contacts normally opened Polarity Inverse www.masimo.com 99 Masimo Root Chapter 11- Service and Maintenance Battery Test To conduct a Battery Test 1. 2. 3. 4. Fully charge Root by connecting it to AC power. Verify that the Root Charging Indicator is illuminated. When Root is fully charged, the Root Charging Indicator turns off. Power On Root and verify that the Root Battery Indicator icon on the Status Bar shows a full charge. Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the device repaired. Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning. Make sure the equipment is fully dry before packing. To return the device for service, see Return Procedure. www.masimo.com 100 Masimo Root Chapter 11- Service and Maintenance Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning. Make sure the equipment is fully dry before packing. Call Masimo at 800326-4890 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. 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 bloodborne pathogens. Return the Root to the shipping address listed in the Contacting Masimo section below. Contacting Masimo Masimo Corporation 40 Parker Irvine, California 92618 Tel:+1 949 297 7000 Fax:+1 949 297 7001 www.masimo.com 101 Masimo Root Chapter 11- Service and Maintenance Warranty with Battery Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: each new Product and the Software media as delivered are free from defects in workmanship or materials. Batteries are warranted for six (6) months. To request a replacement under warranty, Purchaser must contact Masimo for a returned goods authorization. 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 shall be the responsibility of Purchaser. Masimo’s sole obligation under this warranty is to repair or replace any Product or Software that is covered under warranty. Exclusions The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or maintenance needed because of: a) modification of the Product or Software without Masimo’s written authorization; b) supplies, devices or electrical work external to the Product or not manufactured by Masimo; c) disassembly or reassembly of the Product by anyone other than an authorized Masimo agent; d) use of the Product with Sensors or other accessories other than those manufactured and distributed by Masimo; e) use of the Product and Software in ways or in environments for which they are not labeled; and f) neglect, misuse, improper operation, accident, fire, water, vandalism, weather, war, or any act of God. This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product. This warranty does not extend to any Product that has been reprocessed, reconditioned or recycled. This warranty also does not apply to any Products provided to Purchaser for testing or demonstration purposes, any temporary Products Modules or any Products for which Seller does not otherwise receive a usage or purchase fee; all such Products are provided AS-IS without warranty. This warranty, together with any other express written warranty that may be issued by Masimo is the sole and exclusive warranty as to the Product and Software. This warranty is expressly in lieu of any oral or implied warranties, including without limitation any implied warranty of merchantability or fitness for a particular purpose. Masimo shall not be liable for any incidental, special or consequential loss, damage or expense directly or indirectly arising from the use or loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product and Software (under contract, warranty, tort, strict liability or other claim) exceed the amount paid by purchaser for the Products giving rise to such claim. The www.masimo.com 102 Masimo Root Chapter 11- Service and Maintenance limitations in this section shall not be deemed to 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 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. www.masimo.com 103 Masimo Root Chapter 11- Service and Maintenance Restrictions 1. 2. 3. 4. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchaser’s failure to abide by the terms of this Agreement. Nothing in this License provides any rights beyond those provided by 17 U.S.C. §117. 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. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any 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. 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 104 Masimo Chapter 7- Iris • 61 Index Chapter 8- Messages • 65 Chapter 9- Troubleshooting • 67 Cleaning • 83 About • 47 Connectors • 71 About the Main Screen • 27 Contacting Masimo • 86 About the Status Bar • 25 Customizing Windows • 37 About this Manual • 7 AC Power Indicator • 56 Access Control • 45 Device Output • 46 Accessing Main Menu Options • 38 Device Settings • 39 Alarm Interface • 52 Display • 70 Alarm Silence • 54 Alarms • 70 Audio Pause • 55 Electrical • 69 EMC Compliance • 73 Environmental • 69 Back View • 18 Ethernet • 42 Battery Test • 85 Exclusions • 87 Bluetooth • 43 Brightness • 44 Features • 17 Front View • 17 Chapter 1- Description • 17 Chapter 10- Specifications • 69 Guidance and Manufacturer's Declaration-Electromagnetic Emissions • 75 Chapter 11- Service and Maintenance • 83 Chapter 2- Setting Up • 21 Guidance and Manufacturer's Declaration-Electromagnetic Immunity • 75 Chapter 3- Operation • 25 Chapter 4- Radius-7 • 58 Chapter 5- MOC-9 • 59 Guidelines for Setting Up • 21 Chapter 5- O3 Regional Oximetry • 58 www.masimo.com 105 Masimo Root Index Indications for Use • 9 Radical-7 Battery • 44 Initial Battery Charging • 23 Radical-7 Connection • 24 Intended Use • 9 Iris • 49 Recommended Separation Distances • 78 Iris Status Screen • 62 Repair Policy • 85 Replacing the Fuses • 83 Restrictions • 88 Layout • 49 Return Procedure • 86 Lights • 56 Root Battery • 43 Localization • 40 Root Charging Indicator • 57 Menu Navigation • 31 Safety Information, Warnings and Cautions • 11 Messages • 65 Safety Standards Compliance • 74 Sales & End-User License Agreement • 87 Nurse Call Connection • 24 Side Views • 19 Nurse Call Setting Connections • 84 Software Compliance • 73 Nurse Call Specifications • 71 Sounds • 51 Standby and Power Off • 58 Symbols • 80 Outside Back Cover • 91 System Status Lights • 56 Power On • 22 Touchscreen • 70 Power-On Self Test • 84 Trend Download • 55 Product Description and Features • 9 Trend Settings • 47 Product Description, Features and Intended Use • 9 Troubleshooting Radical-7, Radius-7 and MOC-9 Modules • 67 Profiles • 48 Troubleshooting Root • 67 www.masimo.com 106 Masimo Root Index Understanding Windows • 32 Unpacking and Inspection • 21 Using Analog View • 34 Using Iris Connectivity Ports • 63 Using MOC-9 Ports • 59 Using the Touchscreen Interface • 28 Using Trend View • 33 Warranty with Battery • 87 Wi-Fi • 41 Wireless Specifications • 71 www.masimo.com 107 Masimo Root Outside Back Cover Outside Back Cover www.masimo.com 108 Masimo
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