Masimo RDS7 RDS7 User Manual Root

Masimo Corporation RDS7 Root

User Manual

Root™ Operator's Manual
www.masimo.com 1 Masimo Root operating instructions provide the necessary information for proper operation of 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 the instructions in this manual. NOTICE: Purchase or possession of this instrument does not carry any express or implied license to use this instrument with replacement parts which would, alone or in combination with this instrument, fall within the scope of one of the patents relating to this instrument. 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-RDS7 IC Model: RDS-7 FCC ID: VKF-RDS7 Model - RDS-7 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 © 2013 Masimo Corporation Masimo and , are federally registered trademarks of Masimo Corporation. Root is a trademark of Masimo Corporation.
www.masimo.com 2 Masimo The use of the trademarks PATIENT SAFETYNET and PSN is under license from University HealthSystem Consortium. All other trademarks and registered trademarks are property of their respective owners.
www.masimo.com 3 Masimo Contents About this Manual ---------------------------------------------------------------------------- 7 Product Description and Intended Use ------------------------------------------------- 9 Product Description ---------------------------------------------------------------------- 9 Intended Use ------------------------------------------------------------------------------ 9 Safety Information, Warnings, and Cautions---------------------------------------- 11 Safety Information, Warnings, and Cautions ------------------------------------ 11 General Information, Warnings and Cautions ----------------------------------- 12 Compliance Information, Warnings and Cautions ------------------------------ 13 Electrical Information, Warnings and Cautions --------------------------------- 15 Chapter 1: Description -------------------------------------------------------------------- 17 Features ---------------------------------------------------------------------------------- 17 Chapter 2: Setting Up --------------------------------------------------------------------- 21 Unpacking and Inspection ------------------------------------------------------------ 21 Guidelines for Setting Up ------------------------------------------------------------- 21 Power On --------------------------------------------------------------------------------- 22 Initial Battery Charging ---------------------------------------------------------------- 23 Radical-7 Connection ------------------------------------------------------------------ 24 Nurse Call Connection Port ---------------------------------------------------------- 24 Chapter 3: Operation ---------------------------------------------------------------------- 27 About the Main Screen ---------------------------------------------------------------- 28 About the Status Bar ------------------------------------------------------------------- 29 Using the Touchscreen Interface --------------------------------------------------- 31 Menu Navigation ------------------------------------------------------------------------ 34 Understanding Windows -------------------------------------------------------------- 35 Accessing Main Menu Options ------------------------------------------------------ 43 Device Settings ------------------------------------------------------------------------- 44 About -------------------------------------------------------------------------------------- 53
Root Contents www.masimo.com 4 Masimo Trend Settings --------------------------------------------------------------------------- 53 Profiles ------------------------------------------------------------------------------------ 54 Iris ------------------------------------------------------------------------------------------ 54 Layout ------------------------------------------------------------------------------------- 55 Sounds ------------------------------------------------------------------------------------ 57 Alarm Interface -------------------------------------------------------------------------- 58 Trend Download ------------------------------------------------------------------------ 62 Lights -------------------------------------------------------------------------------------- 63 Chapter 4: MOC-9 ------------------------------------------------------------------------- 67 MOC-9 Ports ----------------------------------------------------------------------------- 67 Chapter 5: Iris ------------------------------------------------------------------------------- 69 Iris Connection Ports ------------------------------------------------------------------ 70 Iris Status Screen----------------------------------------------------------------------- 71 Chapter 6: Messages --------------------------------------------------------------------- 73 Chapter 7: Troubleshooting ------------------------------------------------------------- 75 Troubleshooting Radical-7 and MOC-9 Modules ------------------------------- 75 Troubleshooting Root------------------------------------------------------------------ 75 Chapter 8: Specifications ---------------------------------------------------------------- 79 Electrical ---------------------------------------------------------------------------------- 79 Environmental --------------------------------------------------------------------------- 79 Display ------------------------------------------------------------------------------------ 80 Alarms ------------------------------------------------------------------------------------- 80 Nurse Call Specifications ------------------------------------------------------------- 81 Connectors ------------------------------------------------------------------------------- 81 Communication Specifications ------------------------------------------------------ 81 Applicable Standards and Regulations ------------------------------------------- 82 Symbols ----------------------------------------------------------------------------------- 84 Chapter 9: Service and Maintenance ------------------------------------------------- 87 Cleaning ---------------------------------------------------------------------------------- 87
Root Contents www.masimo.com 5 Masimo Replacing the Fuses ------------------------------------------------------------------- 88 Power-On Self Test -------------------------------------------------------------------- 88 Nurse Call Setting Connections----------------------------------------------------- 88 Battery Test ------------------------------------------------------------------------------ 90 Repair Policy ----------------------------------------------------------------------------- 90 Return Procedure ----------------------------------------------------------------------- 91 Contacting Masimo --------------------------------------------------------------------- 91 Sales & End-User License Agreement -------------------------------------------- 92 Warranty ---------------------------------------------------------------------------------- 92 Exclusions -------------------------------------------------------------------------------- 93 Restrictions ------------------------------------------------------------------------------- 93 Index ------------------------------------------------------------------------------------------ 95
www.masimo.com 7 Masimo About this Manual This manual explains how to set up and use Root. Important safety information relating to general use of the product 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 and, death) to the patient or user. The following is an example of a warning: WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to Root or damage to other property. The following is an example of a caution: CAUTION: This is an example of caution statement. A note is given when additional general information is applicable. The following is an example of a note: Note: This is an example of a note.
www.masimo.com 9 Masimo Product Description and Intended Use Product Description 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 rainbow® and SET® measurements from Masimo's Radical-7® handheld monitor  Intuitive, touchscreen navigation for easy and adaptable use in any hospital environment  Flexible measurement expansion through Masimo Open Connect (MOC-9™)  Designed for third-party measurement expansion to allow other companies to add to the platform measurements  Built-in connectivity gateway through Iris™ for standalone devices such as IV pumps, ventilators, beds, and other patient monitors Intended Use Root is a docking station for the Radical-7 handheld monitor. It is also a platform device intended for use with MOC-9 modules. Root is intended to be used in hospitals and hospital-type facilities. It is not intended for home use. For all prescribing information and instructions for use of the compatible medical technologies, refer to the operator’s manual or instructions for use for the specific medical technology.
www.masimo.com 11 Masimo Safety Information, Warnings, and Cautions The following section lists warnings, cautions, notes, and safety information for Root. Root is to be operated by qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. Safety Information, Warnings, and Cautions WARNING: Do not use Root if it appears to be damaged. Contact your biomedical engineering department for guidance before using Root. WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the instrument during operation. WARNING: Do not place Root or accessories in any position that might cause it to fall on the patient. WARNING: Do not use Root during magnetic resonance imaging (MRI). 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: Replace only with fuses of same type, current rating, and voltage rating. WARNING: Do not adjust, repair, open, disassemble or modify Root. 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 device. CAUTION: Do not place Root where the controls can be changed by the patient. Note: Do not monitor more than a single patient at a time on Root.
Root Safety Information, Warnings, and Cautions www.masimo.com 12 Masimo General Information, Warnings and Cautions WARNING: When placed on a flat surface, the device should be secured with a mounting system recommended by Masimo. WARNING: Do not touch, press or rub the touchscreen with abrasive cleaning compounds, instruments, brushes or rough-surface materials, or bring them into contact with anything that could scratch the touchscreen. WARNING: Do not use petroleum-based solutions, acetone solutions or other harsh solvents to clean Root. These substances affect the device’s materials, and device failure can result. CAUTION: Ensure that the speaker is not covered. CAUTION: Do not place Root against a surface that may cause the alarm to be muffled. CAUTION: Should the Radical-7 and Root become unable to communicate, parameters and measurements will not show on the Root display. This will not affect Radical-7's ability to monitor the patient. Note: Root is not intended for use during patient transport outside the healthcare facility. Note: Excessive cleaning solution can flow into the device and cause damage to internal components.
Root Safety Information, Warnings, and Cautions www.masimo.com 13 Masimo Compliance Information, Warnings and Cautions 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: Disposal of product: Comply with local laws in the disposal of the instrument and/or its accessories. 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 FDA or other applicable regulatory authorities, or in any manner inconsistent with the instructions for use or labeling. Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment. Note: This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class A. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. Note: To satisfy RF exposure requirements, this device and its antenna must operate with a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Note: This 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.
Root Safety Information, Warnings, and Cautions www.masimo.com 14 Masimo Note: This Class A digital apparatus complies with Canadian ICES-003. Note: Use Root in accordance with Environmental Specifications section in this manual.
Root Safety Information, Warnings, and Cautions www.masimo.com 15 Masimo Electrical Information, Warnings and Cautions WARNING: Root may be used during electrocautery, but this may affect the accuracy or availability of the parameters and measurements. WARNING: Root may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements. WARNING: Electrical shock hazard: Do not remove the back panel of the device. This could cause injury to personnel or device damage. WARNING: Electrical shock hazard: The battery should be installed and/or removed from Root by qualified personnel only. WARNING: Risk of explosion if battery is replaced with an incorrect type. Replace with Masimo supplied parts only. WARNING: Do not incinerate the battery. CAUTION: To ensure patient electrical isolation, connect only to medical technologies with electrically isolated circuits. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Root. 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. CAUTION: 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.  Use cleaning solutions only as instructed in this operator's manual. See Cleaning on page 87. CAUTION: 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. CAUTION: Electrical shock and flammability hazard: Before cleaning Root, always turn it off and disconnect the power cord from the AC power supply. CAUTION: If Root has not been used or charged within seven (7) days or more, then recharge the battery prior to use.
Root Safety Information, Warnings, and Cautions www.masimo.com 16 Masimo CAUTION: Do not under any circumstances remove the grounding conductor from the power plug. CAUTION: Do not use extension cords or adapters of any type. 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: Use a grounded outlet for proper grounding. A hospital-grade outlet is required. CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer. CAUTION: Failure to plug in the AC power cable promptly after a low battery message may result in the device shutting down. Note: Disconnect the instrument using the AC power cord connector. Note: It is recommended that Root is attached to an AC power source when it is not in use to ensure that the battery remains fully charged. Note: For medical technologies that require AC power, the battery should be adequately charged to ensure backup power in case of AC power disruption. Note: If there is any doubt about the integrity of the protective earth conductor arrangement, operate Root on internal battery power until the AC power supply protective conductor is fully functional.
www.masimo.com 17 Masimo Chapter 1: Description Root can be used in the following ways:  As a docking station and charger for Radical-7  As a bedside monitoring display for parameters on Radical-7 and MOC-9 modules  As a connectivity gateway for standalone devices. Features Front View Ref. Feature Description 1 Docking Station Provides a docking station for the Radical-7. While docked, the Radical-7 can communicate monitored parameters and measurements.* 2 Root Display and Touchscreen Provides an interface for user interactions. 3 Home Button Provides access to the Main Screen. 4 Root Charging Indicator Shows an indication of the battery charge for Root.
Root Chapter 1: Description www.masimo.com 18 Masimo Ref. Feature Description 5 AC Power Indicator Shows an indication of AC power connection Root. 6 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 Description 1 Handle Allows the user to transport Root. 2 Speaker Provides audible notification. 3 Nurse Call Connector Provides a connection to a Nurse Call system.
Root Chapter 1: Description www.masimo.com 19 Masimo Feature Description 4 Ethernet Port Provides a network connection to Root using an RJ-45 cable. 5 USB Ports (2) Provide USB 2.0 connectivity. 6 Power Entry Module Contains the input connector for a hospital grade AC power cord and the fuse holder. 7 Equipotential Ground Connector Provides electrical grounding for Root. 8 Iris Connectivity Ports (4) Provide connection for standalone devices. Side Views Right side Left side Feature Description
Root Chapter 1: Description www.masimo.com 20 Masimo Feature Description 1 System Status Lights Provides an indication of alarms and system messages. See System Status Lights on page 63. 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 21 Masimo Chapter 2: Setting Up Unpacking and Inspection To unpack and inspect Root 1. Remove Root from the shipping carton and examine it for signs of shipping damage or exposed electronics. 2. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact Masimo's Technical Service Department. See Return Procedure on page 91. 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 on page 23. Root should not be operated outside the environmental conditions listed in the specifications section. See Environmental on page 79.
Root Chapter 2: Setting Up www.masimo.com 22 Masimo 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 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 and MOC-9 modules.
Root Chapter 2: Setting Up www.masimo.com 23 Masimo For information about Standby Mode and Power Off, See Standby and Power Off on page 65. Initial Battery Charging To charge the battery for the first time 1. Securely plug the AC power cord into power entry module. 2. Plug the hospital grade AC power cord into an AC power source. 3. Verify that Root's battery is charging by ensuring that the AC Power Indicator (1) is green and the Battery icon on the Status Bar (2) is solid green or has the charging symbol. See AC Power Indicator on page 63 and About the Status Bar on page 29. (1) (2) 4. The Root Charging Indicator remains orange while the battery is charging and will illuminate green when Root is fully charged. See Battery Root on page 47 and About the Status Bar on page 29. See Safety Information, Warnings, and Cautions on page 11.
Root Chapter 2: Setting Up www.masimo.com 24 Masimo 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 on page 64. Nurse Call Connection Port Use a Nurse Call connection cable to connect to a Nurse Call System.
Root Chapter 2: Setting Up www.masimo.com 25 Masimo To connect to a Nurse Call System 1. Identify the Nurse Call connection end (1/4 inch round female connector) of the cable. 2. Insert the Nurse Call connection cable securely into the compatible port on Root. 3. Depending on the connection type of the Nurse Call System, it may be necessary to orient the other end of the Nurse Call connection cable to fit correctly into the system connection. 4. For more information, see Device Output on page 51.
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.
Root Chapter 3: Operation www.masimo.com 28 Masimo About the Main Screen The Main Screen consists of several features. The following shows the Main Screen when three different technologies 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 1 Status Bar Displays system status as well as icons that provide shortcuts to menu items or actions. See About the Status Bar on page 29. 2 Windows Provides a dynamic, user-configurable display area for all the data from Radical-7 or a MOC-9 module. 3 Main Menu icon Provides access to the configuration options for Root, Radical-7 and MOC-9 modules. See Accessing Main Menu Options on page 43.
Root Chapter 3: Operation www.masimo.com 29 Masimo About the Status Bar At the top of the Main Screen is the Status Bar with interactive icons. Each icon provides a shortcut to a menu item or an action on Root. An example is shown below. Ref. Feature Description 1 Alarm Silence Displays alarm status and mutes all audible alarms for Root, Radical-7, and MOC-9 modules. See Alarm Silence on page 60. 2 Audio Pause Displays Audio Pause status and temporarily silences an alarm event. See Audio Pause on page 62. 3 Profiles Provides access to the Profiles screen. The example shown illustrates that Profiles is currently set to Adult for an adult patient. See Profiles on page 54. 4 Bluetooth Provides access to the Bluetooth screen. If this icon is visible, then Bluetooth connectivity has been enabled. See Bluetooth on page 47. 5 Wi-Fi 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 on page 46. 6 Ethernet Provides access to the Ethernet screen. If this icon is visible, then Ethernet connectivity has been enabled. See Ethernet on page 46.
Root Chapter 3: Operation www.masimo.com 30 Masimo Ref. Feature Description 7 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 on page 54. 8 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 on page 64. 9 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 on page 64. 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 on page 57. 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 on page 45.
Root Chapter 3: Operation www.masimo.com 31 Masimo 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 Radical-7 and MOC-9 module(s). 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 on page 41. 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 Switches between toggle states Press left or right of Quickly moves knob left or right
Root Chapter 3: Operation www.masimo.com 32 Masimo Control Applicable Actions Description toggle Labeled Toggle 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 Spinner 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 Slider Slide knob Moves knob Press anywhere along slider path Quickly moves knob to Tap position Slider Spinner 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) position
Root Chapter 3: Operation www.masimo.com 33 Masimo Control Applicable Actions Description 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 Window 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 Well 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 Live Waveform Swipe down Separates pleth and acoustic waveforms Swipe up Combines pleth and acoustic waveforms
Root Chapter 3: Operation www.masimo.com 34 Masimo Control Applicable Actions Description Trend Line Pinch in Zooms in Pinch out Zooms out Pan Changes time range Press y-axis Opens parameter or measurement trend menu Trend Zoom Press '+' Increases time range Press '-' Decreases time range Press time label Resets time range to default Alarm Silence 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 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.
Root Chapter 3: Operation www.masimo.com 35 Masimo 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. Understanding Windows Root creates a Window for Radical-7 and every MOC-9 module connected. 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 and the appropriate MOC-9 module(s). Trend View Analog View Feature Description
Root Chapter 3: Operation www.masimo.com 36 Masimo Feature Description 1 Window The area where all data from a docked Radical-7 or connected MOC-9 module are displayed. 2a Trend View icon Select to see Trend View of the parameters and measurements, if supported. 2b Analog View icon Select to see Analog View of the parameters and measurements, if supported. 3 Waveform Shows a parameter or measurement over time (only for Radical-7 and MOC-9 modules). 4a 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. See Using Trend View on page 37. 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 on page 38. 5 Time Frame (Available only in Trend View). Shows the amount of time the parameter or measurement has been monitored. Increase or decrease the time frame shown by using the pinch or spread gestures respectively. 6 Trend Zoom (Available only in Trend View). Adjust the Time Frame by preset increments using the "+" and "-" buttons. 7 Well Displays parameters and measurements which are not shown as Trend Displays or Analog Gauges.
Root Chapter 3: Operation www.masimo.com 37 Masimo Using Trend View In Trend View, a parameter or measurement is displayed as a graph of its values over time. If a Window supports Trend View, then (Trend View icon) displays 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 Description 1 Value Range Indicates current viewing of the parameter or measurement. Press to access the Trend menu where the minimum and maximum of the range can be modified. 2 Trend 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. 5 Parameter or Measurement Label Indicates the name of the parameter or measurement.
Root Chapter 3: Operation www.masimo.com 38 Masimo 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 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 1 Needle Indicates current status of a parameter or measurement. 2 Alarm Limits Indicate high and low alarm limits for the parameter or measurement. 3 Numeric Value Indicates current reading of the parameter or measurement
Root Chapter 3: Operation www.masimo.com 39 Masimo Ref. Feature Description 4 Parameter or Measurement Label Indicates the name of the parameter or measurement.
Root Chapter 3: Operation www.masimo.com 40 Masimo Specific ranges of the Analog View are: Ref. Feature Color Description 1 Normal Range White Area of the display range where an alarm will not be triggered. 2 Caution Range Yellow Area of the display range that provides a caution indicator. 3 Alarming Range Red Area of the display range where an alarm will be triggered. 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 Half Circle
Root Chapter 3: Operation www.masimo.com 41 Masimo 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 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.
Root Chapter 3: Operation www.masimo.com 42 Masimo 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.
Root Chapter 3: Operation www.masimo.com 43 Masimo Accessing Main Menu Options To access the Main Menu options At the bottom right corner of the touchscreen, press the Main Menu icon. The Main Menu options are: Device Settings See Device Settings on page 44. About See About on page 53. Trend Settings See Trend Settings on page 53. Profiles See Profiles on page 54. Iris See Iris on page 54. Layout See Layout on page 55. Sounds See Sounds on page 57.
Root Chapter 3: Operation www.masimo.com 44 Masimo Device Settings The Device Settings menu allows the user to view and customize settings for Root. The Device Settings options are: Localization See Localization on page 45. Wi-Fi See Wi-Fi on page 46. Ethernet See Ethernet on page 46. Bluetooth See Bluetooth on page 47. Battery Root See Battery Root on page 47. Battery Radical See Battery Radical on page 48 Brightness See Brightness on page 49. Access Control See Access Control on page 50. Device Output See Device Output on page 51.
Root Chapter 3: Operation www.masimo.com 45 Masimo Localization Use the Localization screen to view the current date and time and configure settings related to local time, language and geography. The user can also access the Localization screen by pressing the current time on the Status Bar. See About the Status Bar on page 29. Option Description Factory Default Setting Configurable Settings Language Selects the language display for Root. English Choose from available languages. Date Format Sets the display format for current date. mm/dd/yy mm/dd/yy or dd/mm/yy Time Sets the display format for current time. 12 hour 12 hour or 24 hour 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
Root Chapter 3: Operation www.masimo.com 46 Masimo Wi-Fi Use the Wi-Fi screen to enable or disable Wi-Fi connectivity. When Root is connected to a Wi-Fi network, the Wi-Fi icon on the Status Bar conveys the strength of the connection. See About the Status Bar on page 29. Option Description Factory Default Setting Configurable Settings Wi-Fi Enables or disables Wi-Fi connectivity. Off On or Off Additional fields in the Wi-Fi screen display read-only settings about the Wi-Fi connection that cannot be configured by the user. Your Masimo sales representative can provide necessary information regarding an initial Wi-Fi connection. Ethernet Use the Ethernet screen to enable or disable Ethernet connectivity. When Ethernet connectivity is enabled, the Ethernet icon will appear in the Status Bar. See About the Status Bar on page 29. Option Description Factory Default Setting Configurable Settings Ethernet Enables or disables Ethernet connectivity. On On or Off Additional fields in the Ethernet screen display read-only settings about the Ethernet connectivity that cannot be configured by the user.
Root Chapter 3: Operation www.masimo.com 47 Masimo Bluetooth Use the Bluetooth screen to enable or disable Bluetooth connectivity. When Bluetooth connectivity is enabled, the Bluetooth icon will appear in the Status Bar. See About the Status Bar on page 29. Option Description Factory Default Setting Configurable Settings Bluetooth Enables or disables Bluetooth connectivity. Off On or Off Battery Root Use the Battery Root screen to view the specific percentage of charge on the battery. The user can also access Root's Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 29. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Diagnostics Allows trained personnel to access battery diagnostic information
Root Chapter 3: Operation www.masimo.com 48 Masimo Battery Radical 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 on page 29. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Diagnostics Allows trained personnel to access battery diagnostic information
Root Chapter 3: Operation www.masimo.com 49 Masimo 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). 4 1, 2, 3, 4
Root Chapter 3: Operation www.masimo.com 50 Masimo Access Control Access Control contains configurable options and settings that require a password. To enter Access Control 1. Press the key. 2. When the numeric screen displays, enter the following numbers: 6 2 7 4 Asterisks (****) will be displayed. To undo an entry, press Backspace. 3. Press Enter to access the password protected screen. Note: The password will have to be entered every time this screen is accessed. Option Description Factory Default Setting Configurable Settings All Mute Enabled Enable parameter Alarm Silence menu option. See Sounds on page 57. 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.
Root Chapter 3: Operation www.masimo.com 51 Masimo Option Description Factory Default Setting Configurable Settings 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 Device Output configures the Nurse Call feature on Root. 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 accommodate institutional Nurse Call settings. Normal Normal or Inverted Nurse Call Trigger Controls the source of monitoring which sets off the trigger. Alarms Alarms, Signal IQ Alarms and Signal IQ
Root Chapter 3: Operation www.masimo.com 52 Masimo Note: The Nurse Call feature is disabled when Audio Pause is enabled and Nurse Call Trigger is set to Alarms. For more information about Audio Pause, see Audio Pause on page 62.
Root Chapter 3: Operation www.masimo.com 53 Masimo 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 and MOC-9 modules will display in a separate list. These fields are read-only and cannot be configured by the user. Trend Settings Use the Trend Settings screen to configure trend viewing on the Main Screen and trend data storage on Root. Option Description Factory Default Setting Configurable Settings Default Duration Duration captured by Trend Lines. 2 hours 15, 30, 45 minutes 1, 2, 4, 8, 12, 24 hours Clear Trends Delete all stored trend data. N/A Press Clear to delete all stored trend data.
Root Chapter 3: Operation www.masimo.com 54 Masimo To configure trend settings of specific parameters and measurements, refer to the instructions for use or operator's manuals for Radical-7 and appropriate MOC-9 module(s). Profiles Use the Profiles screen to select patient type. Option Description Factory Default Setting Configurable Settings Patient Type Identifies the Profiles setting in the device. 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 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 on page 71.
Root Chapter 3: Operation www.masimo.com 55 Masimo 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 on page 37. Option Description Factory Default Setting Configurable Settings Layout Style Controls the sizing of Trend Displays. Fixed Fixed or Dynamic The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View.
Root Chapter 3: Operation www.masimo.com 56 Masimo Fixed Ref. Description 1 A set number of Trend Displays can be shown at the same time and all Trend Displays are fixed in size. Every additional parameter or measurement expanded will replace an existing Trend Display. For more information about expanding parameters, see Customizing Windows on page 41. 2 Size of each Trend Display is fixed. Dynamic Ref. Description 1 Size of all Trend Displays decreases or increases to accommodate parameter(s) expanded or minimized. All Trend Displays are always evenly sized.* . For more information about expanding and minimizing parameters, see Customizing Windows on page 41. 2 *Size of each Trend Display is automatically adjusted. *When the number of Trend Displays reaches maximum viewing capacity, additional parameters expanded will result in the replacement of existing Trend Displays.
Root Chapter 3: Operation www.masimo.com 57 Masimo Available Layout When only Radical-7 or a single MOC-9 module is connected to Root, the Available Layout will be 100%. When Radical-7 and/or multiple MOC-9 modules are connected, the user will have the option to select from several pre-configured layouts. Sounds
Root Chapter 3: Operation www.masimo.com 58 Masimo 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 level. Highest volume Slide towards the left to decrease volume to silence. Audio Pause Duration Sets the length of time that the audible alarm remains silenced, when Audio Pause is enabled. See Audio Pause on page 62. 2 minutes 1, 2, 3 minutes, Permanent*, Permanent with Reminder*. 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 on page 50. 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 1 Five (5) beeps: beep-beep-beep, brief pause, beep-beep 2 Three (3) beeps: beep-beep-beep
Root Chapter 3: Operation www.masimo.com 59 Masimo Alarm Source Example Explanation Parameter Level 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). Window Level The example shown here is a "High Impedance" alarm in the lower Window. 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).
Root Chapter 3: Operation www.masimo.com 60 Masimo Alarm Source Example Explanation System Level 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). For more details about specific alarms on Radical-7 and MOC-9 modules, refer to the instructions for use or operator’s manuals for Radical-7 and MOC-9 modules. Alarm Silence The Alarm Silence icon is an indicator as well as a functional button. It always indicates the presence of alarms, and it can be used to temporarily suspend audible alarms for a pre-configured amount of time, known as Silence Duration. Silence Duration configurations vary across different parameters and measurements. For more information about Silence Duration, refer to the instructions for use or operator’s manuals for Radical-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
Root Chapter 3: Operation www.masimo.com 61 Masimo Icon Appearance Description Visual Alarms 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
Root Chapter 3: Operation www.masimo.com 62 Masimo 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 on page 57. 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 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.
Root Chapter 3: Operation www.masimo.com 63 Masimo Lights System Status Lights The System Status Lights provide visual indications of alarms and system messages. The lights will illuminate in different colors depending on the state of the device. To locate the System Status Lights, see Side Views on page 19. 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 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 and MOC-9 modules are not connected: Status Light Message Alarm Priority Low battery Low Service required High AC Power Indicator
Root Chapter 3: Operation www.masimo.com 64 Masimo 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. Radical-7 Charging Indicator
Root Chapter 3: Operation www.masimo.com 65 Masimo When Root is connected to an AC power source, it is able to charge a correctly docked Radical-7. This is true, whether Radical-7 is powered on, in Standby Mode, or powered off. Conversely, when Root is not connected to AC power, it will not charge the Radical-7. The light status provides a visual indication of the battery condition: Light Status Battery Indication Green Battery is fully charged. Orange Battery is charging. Red Battery is unable to charge. Off Battery is fully charged, not being charged. Standby and Power Off To put Root in the Standby Mode or Power Off, follow these steps: State Description Standby Mode 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. Power Off 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 completely shuts down Root and results in a longer startup sequence.
www.masimo.com 67 Masimo Chapter 4: 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. MOC-9 Ports Use a MOC-9 cable to connect other MOC-9 modules to Root. To use an MOC-9 Port 1. Identify the MOC-9 end of the cable. 2. Orient the cable to fit correctly into an MOC-9 Port. 3. Insert the MOC-9 cable securely into any of the three (3) compatible ports on Root.
www.masimo.com 69 Masimo Chapter 5: 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) 5 Root 6 Radical-7 7 MOC-9 modules 8 Patient SafetyNet or Masimo Connectivity Gateway 9 Electronic Health Records system
Root Chapter 5: Iris www.masimo.com 70 Masimo Iris Connection 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. Connect the RS-232 end of the Iris Adapter to the standalone device. 2. Connect the RJ-45 end of the Iris Adapter to any of the four (4) compatible Iris Connectivity Ports on Root using a RJ-45 cable.
Root Chapter 5: Iris www.masimo.com 71 Masimo 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) Port 2
Root Chapter 5: Iris www.masimo.com 72 Masimo Port 3 Port 4 Status and connection type are read-only and not configurable by the user. For more information on Iris connectivity, refer to the instructions for use or operator’s manual for the appropriate version of Masimo Patient SafetyNet.
www.masimo.com 73 Masimo Chapter 6: Messages The following messages are specific to Root: Message Explanation Next Step Battery Charge is Low. The internal battery needs to be charged. System Status Lights flash yellow. Charge Root's battery using AC power. MOC-9 module disconnected (e.g. SedLine Disconnected) 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. For additional messages, refer to the instructions for use or operator's manuals for Radical-7 and MOC-9 modules.
www.masimo.com 75 Masimo Chapter 7: Troubleshooting Troubleshooting Radical-7 and MOC-9 Modules For information on troubleshooting values that are provided from Radical-7 and MOC-9 modules refer to their respective instructions for use or operator's manuals. Troubleshooting Root Symptom Possible Cause Correction Root does not turn on. 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 not operating properly. Replace the fuse. See Replacing the Fuses on page 88. Root turns on, but Main Screen is dim or blank. The brightness setting is not correct. Adjust the brightness setting. See Brightness on page 49. If the condition persists, Root requires service. Contact Masimo Technical Support. See Return Procedure on page 91. Touch functionality is not responsive Internal Failure Root requires service. Contact Masimo Technical Support. See Return Procedure on page 91. Not displaying data from Radical-7 or MOC-9 modules. Connection error. Ensure that the connections are securely in place and properly plugged in, or that the cable is not defective.
Root Chapter 7: Troubleshooting www.masimo.com 76 Masimo Symptom Possible Cause Correction Iris screen does not display connection status for standalone devices. Connection error Unplug and replug the Iris Adapter. Iris screen does not display connection status for standalone devices. Connection error. 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. Internal failure. To silence an alarm, press the Power Button for eight (8) seconds. If alarm continues to sound, Power Off Root. Root requires service. See Return Procedure on page 91. Power Button does not respond when pressed. Power Button may need to be pressed for a longer time. To Power On when turned off or in Standby Mode, press Power Button for two (2) seconds. 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 on page 91. Home Button does not work when pressed. Internal failure. Root requires service. See Return Procedure on page 91. Battery does not charge. AC power cable may be disconnected. Unplug and replug AC power cable.
Root Chapter 7: Troubleshooting www.masimo.com 77 Masimo Symptom Possible Cause Correction Root Charging Indicator illuminates red. Internal failure. Root requires service. See Return Procedure on page 91. Nurse Call does not communicate. Connection error Unplug and replug Nurse Call connector. See Nurse Call Setting Connections on page 88.
www.masimo.com 79 Masimo Chapter 8: Specifications This chapter contains specifications of Root. For information on the specifications of Radical-7, MOC-9 modules, and standalone devices, refer to their respective instructions for use or operator's manuals. Electrical Root AC Power requirements 100-240 VAC~, 47-63 Hz, 65 W (Max) Fuses (2) 2 Amp, Fast Acting, Metric, (5x20mm), 250V 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 10% to 95%, non-condensing Storage Humidity 10% to 95%, non-condensing
Root Chapter 8: Specifications www.masimo.com 80 Masimo Operating Altitude 500 mbar to 1060 mbar -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 Alarms Visual Alarm Priority System Status Light Color High Red Low Yellow
Root Chapter 8: Specifications www.masimo.com 81 Masimo 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 Number of Ports Ethernet 10/100 MBps 1 Nurse Call 1/4 inch round female 1 MOC-9 Masimo Connector 3 USB USB 2.0 2 Iris RS-232/RJ-45 4 Communication Specifications Communication Type Description WLAN Radio Tri Mode IEEE 802.11 a/b/g Security and Authentication Encryption 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES
Root Chapter 8: Specifications www.masimo.com 82 Masimo Authentication Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST Applicable Standards and Regulations Software Compliance EN 60601-1-4:1996 + A1: 1999 EMC Compliance EN 60601-1-2, Class A device ISO 9919, Clause 36 20 V/M radiated immunity 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 Type of Protection Class I (on AC power) Internally powered (on battery power)
Root Chapter 8: Specifications www.masimo.com 83 Masimo Compatibility Standards USA FCC ID: VKF-RDS7 Model - RDS-7: FCC parts 15.207, 15.209, 15.247, and 15.407 Canada IC:7362A-RDS7 IC Model: RDS-7 RSS-210 Europe R & TTE Directive EN 3000 328, EN 301 893, EN 301 489-17
Root Chapter 8: Specifications www.masimo.com 84 Masimo 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 Caution, consult accompanying documents WEEE Compliant Manufacturer Storage temperature limitation Storage altitude limitation Date of Manufacture Storage Humidity Limitation Non-ionizing electromagnetic radiation Keep dry IPX1 Protection against liquid drops falling vertically Fragile, handle with care Federal (USA) law restricts this device to sale by or on the order of a physician Fuse replacement UL, LLC, certification Equipotential ground terminal
Root Chapter 8: Specifications www.masimo.com 85 Masimo Symbols Definition Symbols Definition Federal Communications Commission (FCC) licensing Iris Connection FCC ID, IC, IC Model Identifies unit has been registered as a radio device USB port Mark of conformity to European Medical Instrument 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
www.masimo.com 87 Masimo Chapter 9: 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. 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.
Root Chapter 9: Service and Maintenance www.masimo.com 88 Masimo Replacing the Fuses Should a power-related problem cause one or both of the fuses to fail, the fuse(s) will need to be replaced. The fuses are 1 amp, metric, fast-acting, 5x20mm, 250V. The fuses can be removed by hand or with a 5-millimeter or 3/16-inch screwdriver. To replace the fuse(s) 1. Power Off Root completely. Do not put in Standby Mode. See Standby and Power Off on page 65. 2. Remove the AC power cord from the Power Entry Module in the back panel. 3. Remove the fuse holder by pulling it forward from the Power Entry Module. 4. Remove a fuse by gently pulling the top of the fuse away from the center and then pulling up. The fuse should easily be removed. Do not force. 5. Place a new fuse in the fuse holder. 6. If replacing both fuses, repeat steps 4 and 5 for the second fuse. 7. Slide the fuse holder back into the Power Entry Module and press firmly to make sure it is secure. Root is ready to be reconnected to AC power. If the fuses fail shortly after replacement, Root requires service. See Repair Policy on page 90. Power-On Self Test To conduct a Power-On Self Test 1. Connect Root to AC power, and verify that the AC Power Indicator is illuminated. 2. 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
Root Chapter 9: Service and Maintenance www.masimo.com 89 Masimo disconnected. In addition, the 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 2 contacts normally closed Nurse Call Polarity Inverse 1 and 2 contacts normally opened 2 and 3 contacts normally closed Nurse Call Polarity Normal 1 and 2 contacts normally closed 2 and 3 contacts normally opened Nurse Call Polarity Inverse 1 and 2 contacts normally closed 2 and 3 contacts normally opened Nurse Call Polarity Inverse
Root Chapter 9: Service and Maintenance www.masimo.com 90 Masimo Battery Test To conduct a Battery Test 1. Fully charge Root by connecting it to AC power. 2. Verify that the Root Charging Indicator is illuminated. 3. When Root is fully charged, the Root Charging Indicator turns off. 4. Power On Root and verify that the Root Battery Indicator icon on the Status Bar shows a full charge. Repair Policy Masimo or an Authorized Service Provider must perform warranty repair and service. Have the malfunctioning device repaired. Clean a contaminated and/or dirty device before returning, following the cleaning procedure described in Cleaning on page 87. Make sure the device is fully dry before packing. For information on returning the device for service, see Return Procedure on page 91.
Root Chapter 9: Service and Maintenance www.masimo.com 91 Masimo Return Procedure Clean a contaminated or dirty device before returning, following instructions in Cleaning on page 87. Make sure the device is fully dry before packing. For customers in the United States, contact Masimo Technical Services at 800-326-4890 (select option 2) to obtain support and a RMA number (if required). All customers can also visit http://service.masimo.com for Technical Services contact information for their region. Package the device securely, in the original shipping container if possible, and enclose or include the following information and items:  If provided, include the RMA form supplied by Masimo Technical Services.  Warranty or extended warranty information and a copy of the invoice or other applicable documentation must be included.  Purchase order number to cover repair if the device is not under warranty, or for tracking purposes if it is.  Ship-to and bill-to information.  Contact information (name, telephone/fax number, and country) for any questions about the repair.  A certificate stating the product has been decontaminated for bloodborne pathogens. Return the product to the shipping address given by Masimo Technical Services. Contacting Masimo To contact Masimo, refer to the following: USA, Canada, and Asia Pacific Europe All Other Locations Masimo Corporation 40 Parker Irvine, California 92618 USA Tel:+1 949 297 7000 Fax:+1 949 297 7001 Masimo International Sàrl Puits-Godet 10 2000 Neuchatel- Switzerland Tel:+41 32 720 1111 Fax: +41 32 724 1448 Contact your local Masimo Representative
Root Chapter 9: Service and Maintenance www.masimo.com 92 Masimo Sales & End-User License Agreement This document is a legal agreement between you (“purchaser”) and Masimo Corporation (“Masimo”) for the purchase of this Product (“Product”) and a license in the included or embedded Software (“Software”) except as otherwise expressly agreed in a separate contract for the acquisition of this Product, the following terms are the entire agreement between the parties regarding your purchase of this Product. If you do not agree to the terms of this agreement, promptly return the entire Product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund. Warranty Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: (i) each new Product and the Software media as delivered are free from defects in workmanship or materials, and (ii) the Product and Software will perform substantially as labeled in the directions for use. Masimo’s sole obligation under this warranty is to repair or replace any Product or Software that is covered under warranty. 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.
Root Chapter 9: Service and Maintenance www.masimo.com 93 Masimo Exclusions The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or maintenance needed because of: a) modification of the Product or Software without Masimo’s written authorization; b) supplies, instruments or electrical work external to the Product or not manufactured by Masimo; c) disassembly or reassembly of the Product by anyone other than an authorized Masimo agent; d) use of the Product with Sensors or other accessories other than those manufactured and distributed by Masimo; e) use of the Product and Software in ways or in environments for which they are not labeled; and f) neglect, misuse, improper operation, accident, fire, water, vandalism, weather, war, or any act of God. This warranty does not extend to any Product that has been reprocessed, reconditioned or recycled. This warranty also does not apply to any Products provided to Purchaser for testing or demonstration purposes, any temporary Products Modules or any Products for which Seller does not otherwise receive a usage or purchase fee; all such Products are provided AS-IS without warranty. This warranty, together with any other express written warranty that may be issued by Masimo is the sole and exclusive warranty as to the Product and Software. This warranty is expressly in lieu of any oral or implied warranties, including without limitation any implied warranty of merchantability or fitness for a particular purpose. Masimo shall not be liable for any incidental, special or consequential loss, damage or expense directly or indirectly arising from the use or loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product and Software (under contract, warranty, tort, strict liability or other claim) exceed the amount paid by purchaser for the Products giving rise to such claim. The limitations in this section shall not be deemed to preclude any liability that cannot legally be disclaimed by contract. Restrictions 1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchaser’s failure to abide by the terms of this Agreement. Nothing in this License provides any rights beyond those provided by 17 U.S.C. §117. 2. Use Restrictions: Purchaser may physically transfer the Product from one location to another provided that the Software is not copied. Purchaser may not electronically transfer the Software from the Product to any other instrument. Purchaser may not disclose,
Root Chapter 9: Service and Maintenance www.masimo.com 94 Masimo publish, translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Software or the written materials. 3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void. 4. U.S. Government Rights: If Purchaser is acquiring Software (including the related documentation) on behalf of any part of the United State Government, the following provisions apply: the Software and documentation are deemed to be “commercial software” and “commercial computer software documentation,” respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the Software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement.
www.masimo.com 95 Masimo Index A About • 40, 49 About the Main Screen • 26 About the Status Bar • 23, 26, 27, 42, 43, 44, 45 About this Manual • 7 AC Power Indicator • 23, 58 Access Control • 41, 47, 53 Accessing Main Menu Options • 26, 40 Alarm Interface • 54 Alarm Silence • 27, 56 Alarms • 72 Applicable Standards and Regulations • 73 Audio Pause • 27, 48, 53, 57 B Back View • 18 Battery Radical • 41, 45 Battery Root • 23, 41, 44 Battery Test • 79 Bluetooth • 27, 41, 44 Brightness • 41, 46, 69 C Chapter 1 Description • 17 Chapter 2 Setting Up • 21 Chapter 3 Operation • 25 Chapter 4 MOC-9 • 61 Chapter 5 Iris • 63 Chapter 6 Messages • 67 Chapter 7 Troubleshooting • 69 Chapter 8 Specifications • 71 Chapter 9 Service and Maintenance • 77 Cleaning • 14, 77, 79 Communication Specifications • 73 Compliance Information, Warnings and Cautions • 13 Connectors • 73 Contacting Masimo • 80 Customizing Windows • 29, 38, 52 D Device Output • 24, 41, 48 Device Settings • 40, 41 Display • 72 E Electrical • 71 Electrical Information, Warnings and Cautions • 14 Environmental • 21, 71 Ethernet • 27, 41, 43 Exclusions • 80
Root Index www.masimo.com 96 Masimo F Features • 17 Front View • 17 G General Information, Warnings and Cautions • 12 Guidelines for Setting Up • 21 I Initial Battery Charging • 21, 23 Intended Use • 9 Iris • 28, 40, 50 Iris Connection Ports • 64 Iris Status Screen • 50, 65 L Layout • 40, 51 Lights • 58 Localization • 28, 41, 42 M Menu Navigation • 32 MOC-9 Ports • 61 N Nurse Call Connection Port • 24 Nurse Call Setting Connections • 70, 78 Nurse Call Specifications • 72 P Power On • 22 Power-On Self Test • 77 Product Description • 9 Product Description and Intended Use • 9 Profiles • 27, 40, 50 R Radical-7 Charging Indicator • 24, 28, 59 Radical-7 Connection • 24 Repair Policy • 77, 79 Replacing the Fuses • 69, 77 Restrictions • 81 Return Procedure • 21, 69, 70, 79 Root Charging Indicator • 28, 59 S Safety Information, Warnings, and Cautions • 11, 23 Sales & End-User License Agreement • 80 Side Views • 19, 58 Sounds • 28, 40, 47, 53, 57 Standby and Power Off • 22, 60, 77 Symbols • 75 System Status Lights • 19, 58 T Touchscreen • 72 Trend Download • 57 Trend Settings • 40, 49 Troubleshooting Radical-7 and MOC-9 Modules • 69
Root Index www.masimo.com 97 Masimo U Understanding Windows • 33 Unpacking and Inspection • 21 Using Analog View • 34, 36 Using the Touchscreen Interface • 29 Using Trend View • 34, 51 W Warranty • 80 Wi-Fi • 27, 41, 43
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