Operator's Manual Root®
For Sale in the USA These operating instructions provide the necessary information for proper operation of all models of the Root®. There may be information provided in this manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of Root are prerequisites for its proper use. Do not operate Root without completely reading and understanding these instructions.
Masimo Corporation 52 Discovery 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 3149433 Conforms to ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No.
All other trademarks and registered trademarks are property of their respective owners. © 2020 Masimo Corporation www.masimo.
Contents About This Manual ---------------------------------------------------------- 11 Product Description and Features, Intended Use and Indications for Use 13 Product Description and Features----------------------------------------13 Intended Use -------------------------------------------------------------- 14 Indications for Use -------------------------------------------------------- 14 Contraindication ---------------------------------------------------------- 16 Safety Information, Warnings, and Ca
Root Contents Radius-7 Connection ----------------------------------------------------- 39 MOC-9 Connection ------------------------------------------------------- 40 Nurse Call Connection---------------------------------------------------- 41 Masimo Kite -------------------------------------------------------------- 42 Bluetooth Devices -------------------------------------------------------- 42 Chapter 3: Operation -------------------------------------------------------- 43 About the Main Screen -------
Root Contents Discharging a Patient --------------------------------------------------- 118 Not Monitoring Message ----------------------------------------------- 121 Monitoring Resumed Message ----------------------------------------- 121 Chapter 5: Electronic Medical Record (EMR) Push ----------------------- 123 Determining EMR Push is Active --------------------------------------- 123 Manually Entering Patient Data ---------------------------------------- 123 Sending Patient Data to the EMR -----------
Root Contents Chapter 13: Specifications ------------------------------------------------ 151 Alarms ------------------------------------------------------------------- 151 Nurse Call Specifications ----------------------------------------------- 151 Connectors -------------------------------------------------------------- 152 Electrical ----------------------------------------------------------------- 152 Environmental----------------------------------------------------------- 153 Touchscreen Display ---
Root Contents Masimo Technical Services --------------------------------------------- 178 Contacting Masimo ----------------------------------------------------- 178 Index ----------------------------------------------------------------------- 183 www.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.
Product Description and Features, Intended Use and Indications for Use Product Description and Features Root® is a patient monitoring and connectivity platform. It offers multiple high-impact innovations for broad applications across the continuum of care. Instantly interpretable, high-visibility display of Masimo’s breakthrough SET® and rainbow® SET measurements. Intuitive, touchscreen navigation for easy and adaptable use in any hospital environment.
Root Product Description and Features, Intended Use and Indications for Use Intended Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station).
Root Product Description and Features, Intended Use and Indications for Use hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive 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.
Root Product Description and Features, Intended Use and Indications for Use operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric, infant, and neonatal patients. The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
Safety Information, Warnings, and Cautions CAUTION: Root is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. Refer to Operator's Manuals for ISA, Kite, Patient SafetyNet, Radical-7, Radius-7, 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.
Root Safety Information, Warnings, and Cautions WARNING: To ensure safety, only use Masimo authorized devices with Root. WARNING: To protect against fire hazard, replace only with recommended fuses of the same type, current rating, and voltage rating. WARNING: Do not remove the back panel of the device. This could cause injury to personnel or device damage.
Root Safety Information, Warnings, and Cautions CAUTION: Equipment intended to be connected to signal input/signal output ports should comply with applicable electrical safety standards to further minimize the risk of electric shock. Only devices that have been configured to operate with Root may function properly when connected. CAUTION: Only use the AC power cable provided by Masimo. Using a different AC power cable could cause damage to Root.
Root Safety Information, Warnings, and Cautions Performance Warnings and Cautions WARNING: Root should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: Root may be used during defibrillation. This may affect the accuracy or availability of the parameters and measurements. WARNING: Root may be used during electrocautery. This may affect the accuracy or availability of the parameters and measurements.
Root Safety Information, Warnings, and Cautions CAUTION: Failure to charge Root promptly after a Low Battery alarm may result in the device shutting down. CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to Root.
Root Safety Information, Warnings, and Cautions and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength. Note: Root is provided with a Wi-Fi signal indicator as an indication of Wi-Fi communication. Note: Root’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Root’s primary alarms. Kite WARNING: When using Root the Kite accessory does not generate or manage alarms.
Root Safety Information, Warnings, and Cautions 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.
Root Safety Information, Warnings, and Cautions WARNING: Do not incinerate the battery. WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. WARNING: Users are advised that high-power radars are allocated as primary users (i.e. priority users) of the bands 5.25-5.35 GHz and 5.65-5.
Root Safety Information, Warnings, and Cautions 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.
Root Safety Information, Warnings, and Cautions interference, including interference that may cause undesired operation of the device. Note: Root is not intended for use during patient transport outside the healthcare facility. www.masimo.
Chapter 1: Description Root can be used in the following ways: As a docking station and charger for Radical-7 and Radius-7 Battery Module. As a bedside monitoring display for parameters on Radical-7, Radius-7, and MOC-9 modules. As a connectivity gateway for standalone devices. Features Front View www.masimo.
Root Chapter 1: Description Ref. Feature Description Provides a docking station for the Radical-7 and Radius-7 (Note: Battery Charging Adapter required 1 Docking Station for Radius-7). While docked, the Radical-7 can communicate monitored parameters and measurements.* Root Display 2 and Touchscreen 3 4 5 Home Button Root Charging Indicator AC Power Indicator Radical-7 6 Charging Indicator Provides a frontal display and interface for user interactions. Provides access to the Main Screen.
Root Chapter 1: Description Back View Ref. Feature Description 1 Handle Allows the user to transport Root. 2 Speaker Provides audible notification. 3 Nurse Call Connector 4 Ethernet Port 5 USB Ports (2) www.masimo.com Provides a connection to a Nurse Call system. Provides a network connection to Root using an RJ-45 cable. Provide USB 2.0 connectivity.
Root Chapter 1: Description Ref. Feature 6 Power Entry Contains the input connector for a hospital grade Module AC power cord and the fuse holder. Equipotential 7 Ground Connector 8 Description Iris Connectivity Ports (4) www.masimo.com Provides optional functional earthing for Root to eliminate potential differences. The use of the Equipotential Ground Connector should be in accordance with IEC 60601-1. Provide connection for standalone devices.
Root Chapter 1: Description Side Views Left Side Ref. Feature 1 2 3 Right Side Description System Status Provides an indication of system messages and alarm Lights Power Button MOC-9 Ports (3) www.masimo.com priority. See System Status Lights on page 109. Places Root in Power On, Sleep and Power Off modes. Provide connectivity for MOC-9 modules.
Root www.masimo.
Chapter 2: Setting Up Unpacking and Inspection To unpack and inspect Root 1. Remove Root from the shipping carton and examine it for signs of shipping damage or exposed electronics. 2. Confirm that you have all components for the Root by checking all materials against the packing list: Root AC power cord Note: Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier.
Root Chapter 2: Setting Up Charge Root's battery fully before use. See Initial Battery Charging on page 35. Root should not be operated outside the environmental conditions listed in the specifications section. See Environmental on page 153. Power On The Power Button can be used for Power On, Sleep, and Power Off. To Power On, press the Power Button for two (2) seconds until a single audible tone sounds.
Root Chapter 2: Setting Up For information about Sleep Mode and Power Off, see Sleep and Power Off on page 113. www.masimo.
Root Chapter 2: Setting Up 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 (1) Indicator on page 111 and About the Status Bar on page 45. (2) 4.
Root Chapter 2: Setting Up Radical-7 Connection It is recommended that Root be powered on before performing the steps below. 1. Snap the Radical-7 into the Docking Station. 2. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to power it on. 3. When properly connected, the Radical-7 Charging Indicator light will illuminate. An illuminated Radical-7 Battery icon will also appear in the Status Bar. See About the Status Bar on page 45 4.
Root www.masimo.
Root Chapter 2: Setting Up Radius-7 Connection It is recommended that Root be powered on before performing the steps below. 1. Ensure the Radius-7 Battery Charging Adapter is properly docked in the Docking Station area of Root. 2. Activate the Bluetooth radio on Root. (for more information see Operator’s Manual for Radius-7). 3. Place the Radius-7 Battery Module into the charging area of the Radius-7 Battery Charging Adapter. 4.
Root Chapter 2: Setting Up MOC-9 Connection To connect a MOC-9 module to Root 1. Identify the Masimo Open Connect (MOC-9) end of the module. 2. Insert the MOC-9 end of the module securely into a MOC-9 port on Root. For more information about MOC-9 modules, see Chapter 8: MOC-9 on page 131. www.masimo.
Root Chapter 2: Setting Up Nurse Call Connection Use a Nurse Call connection cable to connect to a Nurse Call System. To connect to a Nurse Call System 1. Identify the Nurse Call connection end (1/4 inch round female connector) of the cable. 2. Insert the Nurse Call connection cable securely into the compatible port on Root. 3.
Root Chapter 2: Setting Up Masimo Kite Masimo Kite Software Application is a passive monitoring interface to Point-of-Care (POC) Masimo medical devices (Root for example) that co-exist under the same Wi-Fi network. Kite remotely displays system and parameter status reported by the POC device on a separate monitor. Root must be on the same network as Kite.
Chapter 3: Operation The information in this chapter assumes that Root is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Root without completely reading and understanding these instructions. www.masimo.
Root Chapter 3: Operation About the Main Screen The Main Screen consists of several features. The following shows the Main Screen when two different devices are connected: Radical-7 (top) showing rainbow® parameters and measurements and SedLine module (bottom) showing brain function measurements. www.masimo.
Root Chapter 3: Operation Ref. Feature 1 2 Status Bar Windows Description Displays system status as well as icons that provide shortcuts to menu items or actions. See About the Status Bar on page 45. Provides a dynamic, user-configurable display area for all the data from connected medical devices. Provides icons for access to Root options for Patient Admit, 3 Action EMR Push, Session Management, Manual Events and the Bar Main Menu. See Accessing Main Menu Options on page 66.
Root Chapter 3: Operation Ref. Feature Description Displays Audio Pause status and temporarily silences 2 Audio Pause an alarm event. See Audio Pause on page 99. Allows for patient monitoring to be temporarily 3 Standby suspended. Available when using Root with Radical-7 Mode or Radius-7. See Standby Mode on page 101. Provides access to the Device Output screen for activation or deactivation of nurse call functions, USB 4 Device port output formats, and IntelliBridge connection.
Root Chapter 3: Operation Ref. Feature Description Provides access to the Wi-Fi screen. If this icon is visible, then wireless connectivity has been enabled. 7 Wi-Fi The icon also indicates signal strength and Patient SafetyNet connectivity. See Wi-Fi on page 78. Provides access to the Ethernet screen. If this icon is 8 Ethernet visible, then Ethernet connectivity has been enabled. See Ethernet on page 80. Provides access to the Iris screen.
Root Chapter 3: Operation Ref. Feature Description Displays charging status for Root and provides access 11 Root Battery to the Battery Root screen. The example shows that the battery is currently charging. See Root Charging Indicator on page 111. Provides access to the Sounds screen to adjust alarm 12 Sounds and pulse tone volume. This icon does not indicate the actual volume level of the alarm and pulse tone. See Sounds on page 72.
Root Chapter 3: Operation About the Action Bar At the bottom of the Main Screen is the Action Bar with interactive icons. Each icon provides a shortcut to a menu item or an action on Root. Ref. Feature 1 Patient Admit/Discharge* Description Provides access to admit or discharge a patient. See Admit and Discharge to Patient SafetyNet. on page 115 Provides access to send measured or manually 2 EMR Push* entered patient parameter data. See Electronic Medical Record (EMR) Push on page 123.
Root Chapter 3: Operation Using the Touchscreen Interface Use the gestures described below to customize the viewing experience, including displaying the highest priority parameters and measurements. The availability of navigation features is dependent on the connected medical devices. Action Illustration Example Description Press and release. Action Press performed once finger is released. Press, move (left, right, up or down), and release. Slide Moves an object across the display.
Root Action Chapter 3: Operation Illustration Example Drag Description See Customizing and Windows on page 62. Drop Press, 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.
Root Control Chapter 3: Operation Applicable Actions Description tile (focused) position Press anywhere When open, collapses spinner outside spinner Slider Slide knob Moves knob Press anywhere Quickly moves knob to Tap position along slider path Slider Spinner Slide knob Press anywhere Moves knob Quickly moves knob to Tap position along slider path Press center When closed, expands the spinner (focused) tile When open, collapses the spinner Swipe up/down When open, scrolls through spinner
Root Chapter 3: Operation Control Applicable Actions Description Icon Menu Press tile Opens menu specified by tile Swipe left or right Scrolls icons left or right (anywhere) Window Press bottom Quickly centers tile corresponding to indicator icon indicator icon Press parameter or When no parameter or measurement measurement alarm is present, opens parameter or measurement menu When parameter or measurement alarm is present, silences parameter or measurement alarm Press and hold Enables par
Root Control Chapter 3: Operation Applicable Actions Description Waveform waveforms Swipe up Combines pleth and acoustic waveforms 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 Press Silences all alarms icon Audio Pause Press Enables Audio Pause Press Opens relevant me
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.
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.
Root Chapter 3: Operation Ref. Feature 1 Window Description The area where all data from a docked Radical-7, Radius-7, or connected MOC-9 module are displayed. This menu allows the user to change between Trend View 2 Action and Analog View. For NIBP and Temperature, the action Menu menu allows access to additional settings. Sensitivity settings can also be selected through the action menu. 3 Waveform Shows a parameter or measurement over time (only for Radical-7, Radius-7, and MOC-9 modules).
Root Chapter 3: Operation Ref. Feature Description (Available only in Analog View) Parameters and measurements are shown as Analog Gauges in Analog 4b Analog View. A parameter's Analog Gauge includes its Alarm Gauge Limits, Numeric Value, Parameter Label, as well as Alarming, Caution and Normal Ranges. See Using Analog View on page 59. 5 Well Displays parameters and measurements which are not shown as Trend Displays or Analog Gauges.
Root Chapter 3: Operation Ref. Feature Description Displays parameter and measurement over a 2 Trend Graph period of time. Zoom in and out of a Trend Graph by pinching out and in. 3 Numeric Value 4 Alarm Limits Parameter or 5 Measurement Label Indicates current reading of the parameter or measurement. Indicate high and low alarm limits for the parameter or measurement, if supported. Indicates the name of the parameter or measurement.
Root Chapter 3: Operation 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 1 Needle 2 Alarm Limits 3 Numeric Value Parameter or 4 Measurement Label www.masimo.com Description Indicates current status of a parameter or measurement. Indicate high and low alarm limits for the parameter or measurement. Indicates current reading of the parameter or measurement.
Root Chapter 3: Operation Specific ranges of the Analog View are: Ref. Feature 1 2 3 Normal Range Caution Range Alarming Range Color White Yellow Red Description Area of the display range where an alarm will not be triggered. Area of the display range that provides a caution indicator. Area of the display range where an alarm will be triggered. Some ranges display as quarter circles, others display as half circles.
Root Quarter Circle www.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.
Root Chapter 3: Operation Order Instruction Step 3 Release the Numeric Value. Minimizing a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it shrinks. Step 2 Drag the Numeric Value to the Well. Step 3 Release the Numeric Value. www.masimo.
Root Chapter 3: Operation Manual Sizing of Windows Expanding and minimizing of windows can be performed from the Main Screen. www.masimo.
Root Chapter 3: Operation Steps Instruction 1 Press and hold the header bar of the window to be resized to activate the feature. Window borders turn blue for all windows visible on the main screen. 2 Touch the up arrow to expand the selected window. 3 Touch the down arrow to minimize the selected window. Note: The selected window can also be resized by touching the bar with an up or down arrow and dragging to resize.
Root Chapter 3: Operation Sounds See Sounds on page 72. Device Settings See Device Settings on page 74. About See About on page 92. Trend Settings See Trend Settings on page 93. Profiles See Profiles on page 94. Iris See Chapter 9: Iris on page 133. Layout Use the Layout screen to select sizing options for Windows and Trend Displays. Available Layouts www.masimo.
Root Chapter 3: Operation When a Radical-7 or Radius-7 is docked to Root and/or multiple MOC-9 modules are connected to Root, the user will have the option to select from several pre-configured layouts. Image below shows layout options available with Radical 7 docked in Root. Note: Rainbow window can be viewed on a Radical 7, using software V1.5.3.5 or greater, in several of the pre-configured layouts. www.masimo.
Root Chapter 3: Operation Additional Settings for Layouts From the Layout screen, press Additional Settings. Change any of the following options: Option Description Trend Controls the sizing of Trend Layout Displays. Analog Range Controls Analog Range Setting. www.masimo.
Root Chapter 3: Operation The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View. www.masimo.
Root Chapter 3: Operation 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 62. 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.
Root Chapter 3: Operation Rainbow The rainbow icon is displayed only when a Radical-7 or Radius-7 is docked to Root. See Operator manuals for Radical-7 or Radius-7. Sounds Use the Sounds screen to control the volume level of sounds and duration of audio pause for Root. Option Description Factory Configurable Settings Default Setting Alarm Sets the alarm volume Highest Volume level. Pulse Tone Sets the pulse tone Volume volume level. www.masimo.
Root Option Chapter 3: Operation Description Factory Configurable Settings Default Setting 1, 2, 3 minutes, Permanent*, Permanent with Reminder*. If Permanent is selected, there will be no audible Sets the length of time Audio Pause Duration alarms when Audio Pause that the audible alarm remains silenced, 2 when Audio Pause is minutes is enabled, but visual alarms will still display. enabled. See Audio If Permanent with Pause on page 99.
Root www.masimo.
Root Chapter 3: Operation 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 76. Kite See Kite on page 77 Wi-Fi See Wi-Fi on page 78. Ethernet See Ethernet on page 80. Bluetooth See Bluetooth on page 81. Root Battery See Root Battery on page 82. www.masimo.
Root Chapter 3: Operation Radical-7 Battery See Radical-7 and Radius-7 Battery on page 82. Brightness See Brightness on page 83. Access Control See Access Control on page 83. Device Output See Device Output on page 88. 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 45. www.
Root Option Chapter 3: Operation Description Factory Configurable Default Settings Setting Language Selects the language display for Root. Choose from English available languages. mm/dd/yy or Date Sets the display format for current Format date. Time Sets the display format for current Format time. Line Sets to match regional power line Frequency frequency. Date Sets the current date. N/A N/A Time Sets the current time. N/A N/A www.masimo.
Root Chapter 3: Operation Kite Use the Kite screen to enable or disable Kite connectivity. Option Description Factory Configurable Default Settings Setting Enable Kite Activates or deactivates Connection an active Kite connection. enabled(no key) disabled disabled Four (4) digit code Pairing Key enabled (key) or Automatic with automatically assigned for active Kite session.
Root Chapter 3: Operation 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 on page 45.
Root Chapter 3: Operation The wireless icon in the Status Bar on Root displays the current connection status. See About the Main Screen on page 44. Icon Description A gray icon indicates Root wireless radio is on, but it is not connected to a wireless network. A blue icon indicates Root is connected to a wireless network, but not communicating with Patient SafetyNet. A green icon indicates Root is connected to a wireless network and communicating directly with Patient SafetyNet.
Root Chapter 3: Operation 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 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 on page 45. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Allows trained personnel to access battery diagnostic Diagnostics information.
Root Chapter 3: Operation Option Description State of Charge Provides a read-only display of battery level remaining. Battery Allows trained personnel to access battery diagnostic Diagnostics information. Brightness Use the Brightness screen to adjust the brightness of the Root display. Option Description Factory Configurable Default Settings Setting Auto Brightness Allows automatic adjustment of Root's display brightness based on ambient Off On or Off 4 1, 2, 3, 4 light.
Root Chapter 3: Operation 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: 6 274 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. www.masimo.
Root Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Adult, Adult Power On Profile Sets the profile used when the device is powered on. Modified, Previous Neonatal, Profile Pediatric, or Previous Profile Enables or disables All Mute parameter Alarm Silence Enabled menu option. See Off On or Off Off 3, 4, or Off Sounds on page 72. Lock Alarm Sets the lowest alarm Volume volume level.
Root Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Standby Reminder Tone Interval Allows for time interval of 30 sec, 1 min, 2 min, 3 min, 5 min, 10 min, or 15 30 sec, 1 min, 2 30 sec min, as well as Off. Allow Allows for Root software Unsigned to be reverted back to Upgrade older version min, 3 min, 5 min, 10 min, 15 min, or Off Off On or Off Off On or Off Enables or disables Sessions Enabled Session Management.
Root Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Data Enables or disables Collection physical data collection Enabled mode. EDF Collection Enabled Off On or Off Off On or Off Off On or Off Off On or Off Enables or disables EDF data collection from SedLine (See Operator's Manual for SedLine) Synchronized Enables or disables Waveforms Synchronization Enabled Waveform view.
Root Chapter 3: Operation Option Description Factory Configurable Default Settings Setting Saves current profile Save as Neo parameter as the Press Save to N/A Neonatal Profile. Factory Options are restored to Defaults factory value. update the profile. N/A Press Restore. *Changes to USB Ports baud rate will take effect after Root is power cycled, turned off then on again. Note: Restore Factory Defaults can only be performed during non-monitoring and no cable connections are present.
Root Option Chapter 3: Operation Description Factory Configurable Settings Default Setting Nurse Call Trigger Controls the source of monitoring which sets Alarms off the trigger. Alarms, Low SIQ, Alarms + SIQ Controls the mechanism of action Nurse Call Polarity for triggering to occur. Should be changed to Normal Normal or Inverted accommodate institutional Nurse Call settings. USB Port 1 USB Port 2 Controls the output None type for USB Port 1. Controls the output IAP type for USB Port 2.
Root Option Chapter 3: Operation Description Factory Configurable Settings Default Setting IntelliBridge Controls the data type Output output for Options* IntelliBridge. Radical Radical Module A SedLine Numerics only Radical SedLine, O3 Sensor 1/2/L/R Capnography SedLine, O3 Sensor 1/2/3/4 *Displays when IntelliBridge is selected as USB Port Output. Note: The Nurse Call feature is disabled when Audio Pause is enabled and Nurse Call Trigger is set to Alarms.
Root Chapter 3: Operation Masimo waveforms from SET, rainbow SET, channels are supported. Note: Root supports the transmission of data only. Validations of the retrieval and display of data transmitted is the responsibility of the IntelliBridge manufacturer. www.masimo.
Root Chapter 3: Operation Parameters Supported IntelliBridge connectivity allows for up to six (6) parameters and two (2) waveforms or eight (8) parameters and no waveform to be displayed on Philips monitors.
Root Option Chapter 3: Operation Description Serial Number Displays the serial number for the device. MCU 1 Displays software version number. Processor Displays processor version number. MCU 2 Displays software version number. MIB Displays MOC-9 interface revision. Information about Radical-7, Radius-7, and MOC-9 modules will display in a separate list. These fields are read-only and cannot be configured by the user.
Root Option Chapter 3: Operation Description Factory Configurable Settings Default Setting Default Duration captured Duration by Trend Graph. Clear Delete all stored Trends trend data. 15, 30, and 45 minutes 2 hours 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours N/A Press Clear to delete all stored trend data. To configure trend settings for specific parameters and measurements, see Directions for Use or Operator's Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s).
Root Chapter 3: Operation Configure Identifies the patient category Profile type. Adult Adult, Pediatric, Neonatal Root can be configured for various patient types by using the Profiles feature. Profile selection controls the management of patient configuration settings on Root. The settings of the three default profiles (Adult, Pediatric, and Neonatal) configure parameter alarms, averaging time, and sensitivity modes.
Root Chapter 3: Operation Priority Alarm Sound High 10-pulse burst Medium 3-pulse burst Alarm Source Example Explanation Parameter The example shown here is a PR Level alarm as the reading (61) exceeds the lower alarm limit (65). Note: The borders of both the PR Trend Display as well as the Window are illuminated red, and the explanation of the alarm is shown at the top of the Window (PR Low < 65). www.masimo.
Root Alarm Source Chapter 3: Operation Example Explanation Window The example shown here is a Level "High Impedance" alarm in the lower Window. Note: The border of the Window illuminates red, and the explanation of the alarm is shown at the top of the Window (High Impedance Detected). System The example shown here is a Level "Low Battery" alarm. Note: The border of the entire Root display is illuminated yellow, and the explanation of the alarm is shown in the Status Bar (Low Battery). www.
Root Chapter 3: Operation For more details about specific alarms on Radical-7, Radius-7, and MOC-9 modules, see Directions for Use or Operator’s Manuals for Radical-7, Radius-7, and MOC-9 modules. Alarm Silence The Alarm Silence icon is an indicator as well as a functional button. It always indicates the presence of alarms, and it can be used to temporarily suspend audible alarms for a pre-configured amount of time, known as Silence Duration.
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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. See About the Status Bar on page 45. By default, Audio Pause is inactive, and the icon appears in the following way: Audio Pause inactive To activate Audio Pause, press the icon.
Root www.masimo.
Root Chapter 3: Operation Standby Mode Standby Mode allows for patient monitoring to be temporarily suspended. The Standby icon (see image below) is located in the top-left corner of the screen. To enable Standby Mode (suspend monitoring) 1. On Root, open the Access Control menu. 2. Swipe the standby enabled button to ON. Return to the home screen on Root, and the Standby icon will appear on the screen in the top-left corner. 3.
Root Chapter 3: Operation Trend Download Root can store up to 96 hours of trend data captured at 2-second intervals from Radical-7, Radius-7, and MOC-9 modules. Trend data from Root can be transferred to a computer via USB for evaluation. Trend data is stored in non-volatile memory, so it is not erased when Root is shut off. Trend data download is initiated using the Masimo Instrument Configuration Tool, which converts the data to a .TXT or .CSV file. www.masimo.
Root Chapter 3: Operation Session Management Session Management, when enabled, allows clinicians to input a label (session name) which will output with data downloaded from Root. Enabling Session Management To enable session management go to Devices Settings. Choose Access Control then slide the Sessions Enabled button to the on position. Starting Session Management Press the session management icon on the Action Bar. Session Name window will open in which you can label the session.
Root Chapter 3: Operation Screen Capture Up to 20 screen capture images can be stored in Root and transferred to a USB drive as PNG files. When the limit of 20 screen captures is reached in Root, every new screen capture will replace the oldest dated screen capture. Note: There must be a folder titled “screen_shot” in the USB drive with a FAT or FAT32 system file to enable the download of the screenshots. Capturing Screens To capture a screen: www.masimo.
Root Chapter 3: Operation Swipe across the Root screen from right to left using two or more fingers simultaneously (see image below). www.masimo.
Root Chapter 3: Operation A confirmation flash will appear on the screen indicating a capture is in progress. A status message [1] will be displayed briefly at the top of the screen and the patient label name will be masked with asterisks [2]. www.masimo.
Root Chapter 3: Operation Reference Example Description The screen capture status message displays the following information: Date: Date of screen capture (YYYYMMDD) Time: Time of screen capture (HHMMSS) Device Serial Number: 10 digit Root serial number 1 Number of Screen Captures: The number of screen captures saved on Root of 20 screen capture limit. When the limit of 20 screen captures is reached, every new screen capture will replace the oldest dated screen capture.
Root Chapter 3: Operation Downloading Screen Captures To download screen captures: 1. Remove any sensors connected to the patient to stop monitoring, and acknowledge any alarms triggered on Root. Note: Before connecting the USB drive in the next step, there must be a folder titled “screen_shot” in the USB drive with a FAT or FAT32 system file to enable the download of the screen captures. 2.
Root Chapter 3: Operation System Status Light Light Status Alarm Indication Priority None None Monitoring has not started. Green None There is currently no active alarms. Flashing Yellow Flashing Red Medium High There is an active alarm of medium priority. 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.
Root Chapter 3: Operation AC Power Indicator Whenever Root is connected to an AC power source, the AC power indicator illuminates. 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 Battery Indication Status Green Battery is fully charged. Orange Battery is charging. Red Battery charging error.
Root Light Chapter 3: Operation Battery Indication Status Off Battery is not being charged. Root is not connected to AC power source. Radical-7 and Radius-7 Charging Indicator When Root is connected to an AC power source, it is able to charge a correctly docked Radical-7 or Radius-7. This is true whether the device is powered on, in Sleep Mode, or powered off. Conversely, when Root is not connected to AC power, it will not charge the device.
Root Chapter 3: Operation Sleep and Power Off To put Root in the Sleep Mode or Power Off Mode, follow these steps: State Description Press and hold the Power Button for two (2) seconds until one Sleep (1) audible tone sounds. Mode Sleep Mode conserves power while enabling a quicker startup sequence. Press and hold the Power Button for eight (8) seconds, until two Power Off Mode (2) audible tones sound. The Home Button will flash, and the Power Button will flash orange.
Chapter 4: Admit and Discharge to Patient SafetyNet The Admit/Discharge icon is located at the bottom left of the screen and allows for clinicians to admit or discharge patient's on Masimo Patient SafetyNet directly from Root. Note: In order to use this feature Masimo Patient SafetyNet software version 5.0.1.0 or higher is required. www.masimo.
Root Chapter 4: Admit and Discharge to Patient SafetyNet Not Admitted A Not Admitted message will appear on the Root screen when the sensor is placed onto a patient and a patient has not yet been admitted on the Root. Press the Admit button on the screen to admit the patient or press skip and the patient data will not be transmitted to the Masimo Patient Safety Net. www.masimo.
Root Chapter 4: Admit and Discharge to Patient SafetyNet Admitting a Patient To admit a patient: 1. Press the admit icon on the bottom-left of the main screen. 2. Enter the authentication PIN. 3. Either press the patient info search button (1) to select existing patient information, or enter new patient information in the data fields (2). 4. Press the assignments search button (3) and select the primary and secondary pagers (4). www.masimo.
Root 5. Chapter 4: Admit and Discharge to Patient SafetyNet Press the Admit button (5). Discharging a Patient To discharge a patient: 1. Press the discharge icon on the bottom-left of the main screen. www.masimo.
Root Chapter 4: Admit and Discharge to Patient SafetyNet 2. Enter the authentication PIN. 3. Press the Discharge button. A confirmation message will appear. 4. Press the Discharge confirmation button. www.masimo.
Root Chapter 4: Admit and Discharge to Patient SafetyNet Note: Once patient is discharged from Root, or session is ended, the NIBP parameter display will be cleared. www.masimo.
Root Chapter 4: Admit and Discharge to Patient SafetyNet Not Monitoring Message When the sensor is off the patient for an extended period of time, a Not Monitoring message will appear on the screen. Acknowledge the message by pressing Cancel or Discharge. Press Discharge to discharge the patient that is currently admitted on the Root, or press Cancel to keep the same patient admitted.
Root Chapter 4: Admit and Discharge to Patient SafetyNet If this is a new patient, press Discharge on the screen to discharge the previous patient. If the same patient is being monitored, press Confirm to continue monitoring the same patient. www.masimo.
Chapter 5: Electronic Medical Record (EMR) Push The Electronic Medical Record (EMR) Push feature allows clinicians to send validated patient vitals data from any of the Masimo devices, MOC-9 modules, or Iris devices connected to Root directly to a Patient Data Management System, such as an Electronic Medical Record (EMR). Determining EMR Push is Active The EMR Push icon appears at the bottom of the Root main screen when the EMR Push feature is active.
Root 1. Chapter 5: Electronic Medical Record (EMR) Push In the EMR Push screen, press a parameter that has a pencil icon . 2. In the manual entry screen, move the slide knob or press the spinner to select the desired parameter value. 3. Press OK to accept the selected manual entry value, or press Cancel to delete the manual entry value and return to the EMR Push screen. After pressing OK, the selected manual entry value appears on the EMR Push screen. www.masimo.
Root Chapter 5: Electronic Medical Record (EMR) Push Sending Patient Data to the EMR Follow the instructions below to send patient data to a data management system using the EMR Push feature. Note: Parameters that appear on the EMR Push screen can be pre-configured on Patient SafetyNet. For questions about pre-configuring EMR Push parameters, see Masimo Technical Services on page 178. 1. Select the EMR Push icon at the bottom of the Root Main Screen. 2.
Root 7. Chapter 5: Electronic Medical Record (EMR) Push Press OK in the Successfully Sent Data to EMR confirmation screen. www.masimo.
Chapter 6: Radical-7 The Radical-7 is a detachable portable noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi), along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), pleth variability index (PVi), and/or acoustic respiration rate (RRa). It can be docked to Root to transfer parameter data to Root.
Chapter 7: Radius-7 The Radius-7 is a patient wearable device for continuous monitoring when the patient is ambulatory. It measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi) along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), and/or acoustic respiration rate (RRa). It uses a Bluetooth connection to transfer parameter data to Root.
Chapter 8: MOC-9 Flexible measurement expansion is enabled through MOC-9. It can display parameters and measurements captured by SedLine, ISA Capnography, and third-party technologies in an all-in-one view on Root. When any MOC-9 module is connected, Root automatically creates a Window that displays all the data from that module.
Root Chapter 8: MOC-9 Using 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.
Chapter 9: 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 Standalone devices connected via Iris (e.g.
Root Chapter 9: Iris Ref. Description 2 Root 3 Patient SafetyNet View Station 4 Patient SafetyNet or Masimo Connectivity Gateway 5 Notification devices 6 Electronic Health Records system Using Iris Connectivity Ports Use Iris Adapters and RJ-45 cables to connect standalone devices to Root. www.masimo.
Root Chapter 9: Iris To connect a standalone device via an Iris Connectivity Port: 1. Connect the Iris Adapter to the standalone device. Refer to the Iris Adapter Directions for Use. 2. Connect the RJ-45 end of the Iris Adapter to any of the four (4) compatible Iris Connectivity Ports on Root using a RJ-45 cable. Iris Icon The Iris icon located in the Status Bar indicates Iris port connectivity status. See About the Status Bar on page 45.
Root Iris Port Chapter 9: Iris Iris Icon Example Description of Connection Connection Status Description Standalone device is connected to Iris adapter in Attempting/Unable Yellow border Root, but Root is to Connect to with solid attempting or unable to Server yellow square connect to a Patient SafetyNet or Connectivity Gateway. No standalone device is connected to Root and Disconnected White border Root is not connected to a Patient SafetyNet or Connectivity Gateway.
Root Chapter 9: Iris Iris Screen The Iris Screen displays Iris port connectivity and standalone device information. To view the Iris Screen: Press the Iris icon in the Status Bar. See About the Status Bar on page 45. The Iris Screen displays 4 Iris port connectivity tiles. Each Iris port connectivity tile displays the [1] Iris port connectivity indicator and [2] device type, model, and Iris port connectivity status. www.masimo.
Root www.masimo.
Root Chapter 9: Iris The Iris port connectivity status is indicated by color and displayed message. See the table below for further description. Connectivity Connection Status Message Status Color Connected Connecting to Iris Server Disconnected Green tile Standalone device is successfully border connected to Root, and Root is Green successfully connected to Patient indicator SafetyNet or Iris Gateway.
Chapter 10: Bluetooth Devices Flexible measurement expansion is possible through the Root Bluetooth connection. Root displays measurements captured by external device technologies in an all-in-one view on Root. When an external device is connected to Root via Bluetooth, Root automatically creates a window that displays all the data from that device on the Main Screen. Connect Device to Root Connect an external device to Root using Bluetooth 1. Ensure Bluetooth is enabled on Root. See Bluetooth on page 81.
Chapter 11: Messages The following messages are specific to Root: Message Battery Charge is Low. Explanation Next Step The internal battery needs to be charged. System Status Lights flash yellow. MOC-9 module Charge Root's battery using AC power. Reconnect module or Disconnected A MOC-9 module is acknowledge message by (e.g. SedLine disconnected from Root. pressing the Alarm Silence icon.
Chapter 12: Troubleshooting Troubleshooting Radical-7, Radius-7, and MOC-9 Modules For information on troubleshooting values that are provided from Radical-7, Radius-7, and MOC-9 modules, refer to their respective Instructions for Use or Operator's Manuals. Troubleshooting Root Symptom Possible Cause Power Button not pressed long Correction Press Power Button for two (2) seconds. enough. Root does not turn The battery may Connect Root to AC power to on. charge battery. be depleted.
Root Symptom Chapter 12: Troubleshooting Possible Cause Correction Adjust the brightness setting. Root turns on, but See Brightness on page 83. The brightness If the condition persists, Root Main Screen is dim setting is not or blank. requires service. Contact Masimo correct. Technical Services. See Return Procedure on page 177. Touch functionality is not responsive. Root requires service. Contact Internal failure. Masimo Technical Services. See Return Procedure on page 177.
Root Symptom Chapter 12: Troubleshooting Possible Cause Correction If the problem persists, refer to instructions for use or operator's Iris screen does not display connection status for manual for the connected Connection error. standalone devices. standalone devices or Iris section of the instructions for use or operator’s manual for the appropriate version of Patient SafetyNet. To silence an alarm, press the Power Button for eight (8) Root has a continuous speaker Internal failure. tone.
Root Symptom Chapter 12: Troubleshooting Possible Cause Home Button does not work when Internal failure. pressed. Battery does not charge. AC power cable may be Root requires service. See Return Procedure on page 177. Unplug and replug AC power cable. disconnected. Root Charging Indicator Correction Internal failure. illuminates red. Root requires service. See Return Procedure on page 177. Unplug and replug Nurse Call Nurse Call does not communicate. Connection error. connector.
Root Symptom Chapter 12: Troubleshooting Possible Cause Correction Unable to manually Parameter is not enter parameter configured for See Masimo Technical Services data in EMR Push manual entry on on page 178. screen. Patient SafetyNet. www.masimo.
Chapter 13: Specifications This chapter contains specifications of Root. For information on the specifications of Radical-7, Radius-7, MOC-9 modules, and standalone devices, see Directions for Use or Operator's Manuals for these devices. Alarms Audio Alarm System Status Type Light Color High Priority Flashing Red Audio Description 10-pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s Medium Flashing Yellow Priority Low Priority 3-pulse burst, pulse spacing: 0.375s, 0.
Root Chapter 13: Specifications Connectors Connector Type Ethernet Number of Ports 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 Electrical Root AC Power requirements Fuses (2) 100-240 VAC~, 47-63 Hz, 65VA Max 2 Amp, Time Delay High Breaking Capacity (5x20mm), 250V Battery Type www.masimo.
Root Chapter 13: Specifications Root Voltage 10.8V (Nominal) Capacity 4 hours* Maximum Charging Time 4 hours *This represents approximate run time at the lowest brightness, using a fully charged battery.
Root Chapter 13: Specifications Touchscreen Display Characteristic Description Type Backlit Active Matrix TFT LCD Resolution 1280 x 800 pixels Size 10.1 in (25.65 cm) Diagonal Color 24 bit RGB Touchscreen Type Multi-Touch P-Cap Wireless Specifications Communication (Wi-Fi) Type WLAN Radio: IEEE 802.11 a/b/g 2.4 GHz - 802.11b/g/n: 2412-2472 MHz Frequency 5.0 GHz - 802.
Root Chapter 13: Specifications Communication (Wi-Fi) 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.
Root Chapter 13: Specifications Security and Authentication Encryption Authentication 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST www.masimo.
Root Chapter 13: Specifications Radio Compliance USA FCC ID: VKF-MWM2 Model: RDS-7A or RDS-7 Canada IC:7362A-MWM2 Model: RDS-7A or RDS-7 RSS-247 Europe EU Radio Equipment Directive (RED 2014/53/EU) EN 300 328:V2.1.1 EN 301 893:V2.1.1 EN 301 489-1:V2.2.0 EN 301 489-17 V3.1.1 EN 62311 Japan TELEC Article 2-1-19 Article 2-1-19-3 Article 2-1-19-3-2 Korea KN 301 489-1 V2.2.0 KN 301 489-17 V3.1.1 www.masimo.
Root Chapter 13: Specifications Compliance Electrical Safety ANSI/AAMI ES 60601-1:2005 CAN/CSA C22.2 No. 60601-1:2008 EN 60601-1:2006 + A1: 2014 IEC 60601-1:2005 + A1: 2012 IEC 60601-1-8:2006 IEC 60601-2-49:2011 ISO 80601-2-56:2012 EMC Compliance EN 60601-1-2, 2007 Class B Software Compliance EN 62304:2006 www.masimo.
Root Chapter 13: Specifications Equipment Classification per IEC 60601-1 Type of Protection Class I (on AC power) Internally powered (on battery power) Degree of Protection of Electrical Defibrillation proof BF-Applied Part1 Shock Protection against harm from IPX1 Protection against liquid drops liquid ingress falling vertically Mode of Operation Continuous Operation Connected devices should be used in accordance with their respective 1 degrees of electrical protection to maintain electrical saf
Root Chapter 13: Specifications Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment - Guidance ME Equipment uses RF energy only for its RF Emissions CISPR 11 Group 1 internal function.
Root Chapter 13: 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.
Root Chapter 13: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Surge IEC 61000-4-5 +1 kV - Mains power quality differential should be that of a typical mode --- +2 kV - hospital environment. common mode Voltage dips, short 100% for 0.5 Mains power quality interruptions and should be that of a typical voltage variations on power supply input lines. IEC 61000-4-11 Power frequency cycle commercial or hospital 60% for 5 environment.
Root Chapter 13: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Compliance Recommended Test Level Level Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 Separation Distance MHz Radiated RF 3 V/m IEC 61000-4-3 80 MHz to 2.5 3 V/m 80 MHz to 800 MHz: GHz 800 MHz to 2.5 GHz: www.masimo.
Root Chapter 13: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as --- --- --- determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.
Root Chapter 13: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Root Chapter 13: 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.
Root Chapter 13: Specifications 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.
Root Chapter 13: Specifications Symbols The following symbols may appear on the product or product labeling: Symbol Description Symbol Follow instructions for Description Consult instructions for use use Mark of conformity to ETL Intertek certification European medical See Declarations on Page device directive 1 for certifications 93/42/EEC Fuse replacement- Only Protection against replace with time delay vertically falling water fuses specified in this drops Instructions for Use Defib
Root Symbol Chapter 13: Specifications Description Symbol Description Caution: Federal (USA) law restricts this Authorized representative device to sale by or on in the European community the order of a physician Federal Communications Identifies unit has been Commission (FCC) registered as a radio device Licensing Non-ionizing Innovation, Science and electromagnetic Economic Development radiation Canada (ISED) Warning, electricity Biohazardous Waste Not for continuous Electrostatic m
Root Symbol Chapter 13: Specifications Description Symbol Description Catalog number (model Manufacturer number) Date of manufacture Masimo reference number YYYY-MM-DD Storage temperature Serial number range Keep dry Fragile, handle with care Storage humidity Do not use if package is limitation damaged Atmospheric pressure Equipotential Ground limitation Terminal AC current Fuse Wireless features can be used in member states with Wireless Symbol level the restriction of indoor use i
Root Symbol Chapter 13: Specifications Description Symbol Description RS-232 Interface Ethernet Analog Out Interface Nurse Call Interface Greater than USB port China Restriction of Less than Hazardous Substances The names and content of the toxic and hazardous --- --- substances or elements shall be provided in the product instruction manual Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.
Chapter 14: Service and Maintenance This chapter contains information about cleaning, battery operation, performance verification, service, repair, and warranty. Cleaning Root is a non-sterile and reusable device. The surface of the Root should be cleaned when the device is visibly dirty, before and after each procedure, and/or according to hospital practice. To surface clean, wipe down the outer surface of Root using any of the following: Cidex Plus (3.
Root Chapter 14: Service and Maintenance To replace the fuse(s) 1. Power Off Root completely. Do not put in Sleep Mode. See Sleep and Power Off on page 113. 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.
Root Chapter 14: Service and Maintenance Power-On Self Test To conduct a Power-On Self Test 1. Connect Root to AC power, and verify that the AC Power Indicator 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.
Root Chapter 14: Service and Maintenance Cable Type Nurse Call Event Menu Setting 1 and 2 contacts normally Nurse Call Polarity opened Normal 2 and 3 contacts normally 3-Circuit closed 1 and 2 contacts normally Nurse Call Polarity closed Inverse 2 and 3 contacts normally opened Battery Test To conduct a Battery Test 1. Fully charge Root by connecting it to AC power. 2. Verify that the Root Charging Indicator is illuminated. 3.
Root Chapter 14: Service and Maintenance Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning on page 173. Make sure the equipment is fully dry before packing. To return the device for service, see Return Procedure on page 177. Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning on page 173. Make sure the equipment is fully dry before packing.
Root Chapter 14: Service and Maintenance Masimo Technical Services To contact Masimo Technical Services, refer to the Masimo Technical Services web page: http://www.masimo.co.
Root Chapter 14: Service and Maintenance To request a replacement under warranty, Purchaser must contact Masimo and obtain a returned goods authorization number so that Masimo can track the Product. If Masimo determines that a Product must be replaced under warranty, it will be replaced and the cost of shipment covered. All other shipping costs must be paid by purchaser.
Root Chapter 14: Service and Maintenance or warranties regarding the Product. No other warranty applies, express or implied, including without limitation, any implied warranty of merchantability, fitness for a particular purpose, satisfactory quality, or as to the use of reasonable skill and care. See the licensing terms for the terms and conditions that apply to and Software accompanying the Product.
Root Chapter 14: Service and Maintenance 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.
Root 4. Chapter 14: Service and Maintenance 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.
Index Bluetooth • 31, 49, 53, 93 A Brightness • 49, 54, 97 About • 44, 59 C Bluetooth Devices • 27 About the Action Bar • 32, 66 Capturing Screens • 67 About the Main Screen • 29, 52 Chapter 1 About the Status Bar • 23, 24, 30, Description • 17 50, 51, 52, 53, 54, 64, 89, 90 Chapter 10 About This Manual • 7 Bluetooth Devices • 27, 93 AC Power Indicator • 23, 70 Chapter 11 Access Control • 48, 49, 55 Messages • 95 Accessing Main Menu Options • Chapter 12 30, 32, 44 Troubleshooting • 9
Root Index Chapter 5 Customizing Windows • 33, 41, 47 Electronic Medical Record (EMR) Push • 32, 79 D Chapter 6 Radical-7 • 81 Determining EMR Push is Active • Chapter 7 79 Radius-7 • 83 Device Output • 26, 30, 50, 57, 116 Chapter 8 Device Settings • 44, 49 MOC-9 • 26, 85 Chapter 9 Discharging a Patient • 75 Iris • 31, 44, 87 Downloading Screen Captures • Cleaning • 115, 117 69 Cleaning and Service Warnings E and Cautions • 14 Compliance • 105 Electrical • 102 Compliance Warnings an
Root Index Lights • 69 G Limitation of Warranty • 118 Guidance and Manufacturer's Limited Warranty • 118 Declaration-Electromagnetic Localization • 32, 49, 50 Emissions • 106 Guidance and Manufacturer's M Declaration-Electromagnetic Immunity • 107 Manual Sizing of Windows • 43 Guidelines for Setting Up • 21 Manually Entering Patient Data • 79, 80 I Masimo Kite • 27 Indications for Use • 9 Masimo Technical Services • 79, 80, 98, 99, 117 Initial Battery Charging • 21, 23 IntelliBridge Conne
Root Index Nurse Call Specifications • 101 Recommended Separation Distances • 110 P Repair Policy • 115, 117 Parameters Supported • 59 Replacing the Fuses • 97, 115 Patient SafetyNet System • 14 Restrictions • 119 Performance Warnings and Return Procedure • 21, 97, 98, 117 Cautions • 12 Power On • 21 Root Battery • 23, 49, 53 Power-On Self Test • 116 Root Charging Indicator • 31, 70 Product Description and Features S •9 Product Description and Safety Information, Warnings, Features, Inte
Root Index Standby Mode • 30, 56, 65 W Symbols • 111 Wi-Fi • 31, 49, 51, 98 System Status Lights • 20, 69 Wireless Specifications • 103 T Touchscreen Display • 103 Trend Download • 66 Trend Settings • 44, 60 Troubleshooting Radical-7, Radius-7, and MOC-9 Modules • 97 Troubleshooting Root • 97 U Understanding Windows • 37 Unpacking and Inspection • 21 Using Analog View • 38, 39 Using Iris Connectivity Ports • 88 Using MOC-9 Ports • 85 Using the Touchscreen Interface • 33 Using Trend View • 38 www.
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