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Masimo Root Operator's Manual

With noninvasive blood pressure and temperature
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  • Page 1 Operator's Manual ® Root with noninvasive blood pressure and temperature...
  • Page 3 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.

  • Page 5: Table Of Contents

    Nurse Call Connection ------------------------------------------------------------------------------- 30 Attach the Probe Well -------------------------------------------------------------------------------- 30 Attach the Temperature Probe ---------------------------------------------------------------------- 31 Attach NIBP Cuff --------------------------------------------------------------------------------------- 31 Masimo Kite --------------------------------------------------------------------------------------------- 31 Bluetooth Devices -------------------------------------------------------------------------------------- 31 Chapter 3: Operation ------------------------------------------------------------------------------------- 33 About the Main Screen ------------------------------------------------------------------------------- 33...
  • Page 6 Root NIBPT Contents Using the Touchscreen Interface-------------------------------------------------------------------- 37 Menu Navigation -------------------------------------------------------------------------------------- 40 Understanding Windows ----------------------------------------------------------------------------- 41 Accessing Main Menu Options ---------------------------------------------------------------------- 49 Alarm Interface ----------------------------------------------------------------------------------------- 77 Trend Download ---------------------------------------------------------------------------------------- 81 Session Management --------------------------------------------------------------------------------- 82 Screen Capture ----------------------------------------------------------------------------------------- 83 Lights ---------------------------------------------------------------------------------------------------- 86...
  • Page 7 Contents Iris Icon ------------------------------------------------------------------------------------------------ 119 Iris Screen --------------------------------------------------------------------------------------------- 120 Chapter 12: Bluetooth Devices ------------------------------------------------------------------------ 123 Connect Device to Root ----------------------------------------------------------------------------- 123 Chapter 13: Messages ----------------------------------------------------------------------------------- 125 Chapter 14: Troubleshooting -------------------------------------------------------------------------- 129 Troubleshooting Radical-7, Radius-7, and MOC-9 Modules ----------------------------------- 129 Troubleshooting Root ------------------------------------------------------------------------------- 129...
  • Page 8 Nurse Call Setting Connections ------------------------------------------------------------------- 159 Battery Test ------------------------------------------------------------------------------------------- 160 Repair Policy ------------------------------------------------------------------------------------------ 160 Return Procedure ------------------------------------------------------------------------------------ 160 Masimo Technical Services ------------------------------------------------------------------------ 160 Contacting Masimo ----------------------------------------------------------------------------------- 161 Appendix: Concepts of Alarm Response Delay ----------------------------------------------------- 163 Concepts of Alarm Response Delay --------------------------------------------------------------- 163 Index ------------------------------------------------------------------------------------------------------- 165 www.masimo.com...

  • Page 9: About This Manual

    About This Manual This manual explains how to set up and use Root® with noninvasive blood pressure and temperature. Important safety information relating to general use of Root appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual.

  • Page 11: Product Description And Features, Intended Use And Indications For Use

    Ability to display data from external devices using Bluetooth. For all prescribing information and instructions for use of the compatible medical devices that are connected to Root, see Operator’s Manual or Instructions for Use for the specific medical device. Intended Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.
  • Page 12 In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO and pulse rate to multi-parameter devices for the display of those devices.

  • Page 13: Contraindication

    Root NIBPT Product Description and Features, Intended Use and Indications for Use The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:...

  • Page 15: Safety Information, Warnings, And Cautions

    WARNING: Do not use Root during or nearby magnetic resonance imaging (MRI) or in an MRI environment. WARNING: Do not place Root or accessories in any position that might cause it to fall on the patient. WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the device during operation.
  • Page 16 Note: Do not monitor more than a single patient at a time on Root. Note: It is recommended that Root is attached to an AC power source when it is not in use to ensure that the battery remains fully charged.
  • Page 17 Root NIBPT Safety Information, Warnings, and Cautions WARNING: Do not use or stop blood pressure measurements if the patient appears to be affected by the pressurization of the cuff due to a physical condition (i.e. pregnant, pre-eclamptic, etc.) WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference.

  • Page 18: Performance Warnings And Cautions

    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.
  • Page 19 Note: Root’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Root’s primary alarms. Note: When the Root monitor is in synchronized waveform view, the EEG Chart Speed of the SedLine Window cannot be changed.

  • Page 20: Cleaning And Service Warnings And Cautions

    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.

  • Page 21: Compliance Warnings And Cautions

    These limits are designed to provide reasonable protection against harmful interference in a hospital environment. Note: This Class A digital apparatus complies with Canadian ICES-003. Note: Root is not intended for use during patient transport outside the healthcare facility. www.masimo.com Masimo...

  • Page 23: Chapter 1: Description

    Radical-7 can communicate monitored parameters and measurements.* Root Display and Provides a frontal display and interface for user interactions. Touchscreen Home Button Provides access to the Main Screen. Root Charging Shows an indication of the battery charge for Root. Indicator www.masimo.com Masimo...
  • Page 24 Back View Ref. Feature Description Handle Allows the user to transport Root. Speaker Provides audible notification. Nurse Call Provides a connection to a Nurse Call system. Connector Ethernet Port Provides a network connection to Root using an RJ-45 cable. www.masimo.com Masimo...
  • Page 25 Power Entry Contains the input connector for a hospital grade AC power cord Module and the fuse holder. Provides optional functional earthing for Root to eliminate Equipotential potential differences. The use of the Equipotential Ground Ground Connector Connector should be in accordance with IEC 60601-1.
  • Page 26 Feature Description Provides an indication of system messages and System Status Lights alarm priority. See System Status Lights on page Places Root in Power On, Sleep, and Power Off Power Button modes. MOC-9 Ports (3) Provide connectivity for MOC-9 modules.

  • Page 27: Chapter 2: Setting Up

    If anything is missing or damaged, contact Masimo's Technical Service Department. See Return Procedure on page 160. 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: •...

  • Page 28: Power On

    Power Button for two (2) seconds until a single audible tone sounds. Once Root turns on, if no Radical-7, Radius-7, or MOC-9 module is connected, the Root display shows the following message: Please Connect a Device. The user is now able to connect Radical-7, Radius-7, and MOC-9 module.

  • Page 29: Initial Battery Charging

    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.

  • Page 30: Radical-7 Connection

    Chapter 2: Setting Up Radical-7 Connection It is recommended that Root be powered on before performing the steps below. Snap the Radical-7 into the Docking Station. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to power it on.

  • Page 31: Moc-9 Connection

    Root NIBPT Chapter 2: Setting Up When properly connected, an illuminated Radius-7 Battery icon will appear in the Status Bar, and the rainbow Window will appear on the Root display. MOC-9 Connection To connect a MOC-9 module to Root Identify the Masimo Open Connect (MOC-9) end of the module.

  • Page 32: Nurse Call Connection

    Root NIBPT Chapter 2: Setting Up Insert the MOC-9 end of the module securely into a MOC-9 port on Root. For more information about MOC-9 modules, see Chapter 10: MOC-9 on page 115. Nurse Call Connection Use a Nurse Call connection cable to connect to a Nurse Call System.

  • Page 33: Attach The Temperature Probe

    Kite and the device are connected to the same network. To add Root to Kite to view parameter status, refer to the Masimo Kite Software Application Operator's Manual.

  • Page 35: Chapter 3: Operation

    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.

  • Page 36: About The Status Bar

    About the Status Bar At the top of the Main Screen is the Status Bar with interactive icons. Each icon provides a shortcut to a menu item or an action on Root. An example is shown below. Ref. Feature Description Displays alarm status and temporarily mutes all audible alarms for Root, Radical-7, Radius-7, and MOC-9 modules.
  • Page 37 Battery See Radical-7 and Radius-7 Charging Indicator on page 87. Displays charging status for Root and provides access to the Battery Root screen. The example shows that the battery is currently charging. Root Battery See Root Charging Indicator on page 87.

  • Page 38: About The Action Bar

    Provides access to device control options for Root and connected medical devices. See Accessing Main Menu Options Main Menu on page 49. *These icons will only appear when Root is connected to a Patient SafetyNet system v5.0.0.0 or higher or an Iris Gateway system. www.masimo.com Masimo...

  • Page 39: Using The Touchscreen Interface

    See Customizing Windows on desired position, and drop it by page 46. Drop 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...
  • Page 40 Root NIBPT Chapter 3: Operation Control Applicable Actions Description Labeled Toggle Slide knob Switches between toggle states Press left or right of Quickly moves knob left or right toggle Press label Quickly moves knob left or right Spinner Press center (focused)
  • Page 41 Root NIBPT Chapter 3: Operation Control Applicable Actions Description Swipe left or right Scrolls icons left or right (anywhere) Press bottom Quickly centers tile corresponding to indicator icon indicator icon Window Press parameter or When no parameter or measurement alarm is...

  • Page 42: Menu Navigation

    To navigate to the previous screen, press the arrow at the top left corner of the touchscreen. To return to the Main Screen, at any time, press the Home Button at any time. The Home Button is always illuminated when Root is powered on. www.masimo.com...

  • Page 43: Understanding Windows

    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.
  • Page 44 Root NIBPT Chapter 3: Operation Ref. Feature Description The area where all data from a docked Radical-7, Radius-7, or connected Window MOC-9 module are displayed. This menu allows the user to change between Trend View and Analog Action View. For NIBP and Temperature, the action menu allows access to Menu additional settings.
  • Page 45 Root NIBPT Chapter 3: Operation Using Trend View In Trend View, a parameter or measurement is displayed as a graph of its values over time. The following diagram and table describe key features of a parameter's Trend Display in Trend View.
  • Page 46 Root NIBPT Chapter 3: Operation Using Analog View The Analog View shows parameter and measurement data as a needle pointing to graduations in a circular array around a dial. This view provides indications of change that can be interpreted at a quick glance.
  • Page 47 Root NIBPT Chapter 3: Operation Specific ranges of the Analog View are: Ref. Feature Color Description White Area of the display range where an alarm will not be Normal Range triggered. Caution Range Yellow Area of the display range that provides a caution indicator.
  • Page 48 Root NIBPT 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.
  • Page 49 Root NIBPT Chapter 3: Operation Minimizing a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it shrinks. Step 2 Drag the Numeric Value to the Well. Step 3 Release the Numeric Value. www.masimo.com Masimo...
  • Page 50 Root NIBPT Chapter 3: Operation Manual Sizing of Windows Expanding and minimizing of windows can be performed from the Main Screen. Steps Instruction 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.

  • Page 51: Accessing Main Menu Options

    Root NIBPT Chapter 3: Operation Accessing Main Menu Options To access the Main Menu options At the bottom right corner of the touchscreen, press the Main Menu icon. The Main Menu options are: Layout See Layout on page 50. rainbow...
  • Page 52 Root NIBPT Chapter 3: Operation Iris See Chapter 11: Iris on page 117. Layout The Layout menu allows the user to view and customize settings for the main screen layout by changing any of the following options: Available Layouts See Available Layouts on page 51.
  • Page 53 When a Radical-7 or Radius-7 is docked to Root and/or multiple MOC-9 modules are connected to Root, the user will have the option to select from several pre-configured layouts. The image below is an example of Available Layouts in Root with Radical-7 docked.
  • Page 54 Root NIBPT Chapter 3: Operation Active Channels From the Layout screen, press Active Channels. In the Active Channels screen, Temperature and NIBP can be enabled to display on the Root main screen. Factory User Configurable Ref Option Description Default Settings...
  • Page 55 Root NIBPT Chapter 3: Operation Additional Settings for Layouts From the Layout screen, press Additional Settings. Change any of the following options: Option Description Factory Default User Configurable Settings Settings Trend Controls the sizing of Trend Dynamic Fixed or Dynamic Layout Displays.
  • Page 56 *When the number of Trend Displays reaches maximum viewing capacity, additional parameters expanded will result in the replacement of existing Trend Displays. 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. Temperature...
  • Page 57 Root NIBPT Chapter 3: Operation Trends See Trends for Temperature on page 56. Additional Settings See Additional Settings for Temperature on page 57. Alarms for Temperature From the Temperature screen, touch Alarms, and then change any of the following options:...
  • Page 58 Root NIBPT Chapter 3: Operation Trends for Temperature From the Temperature screen, touch Trends, and then change any of the following options: Factory Default Configurable Options Description Settings Options The Temperature Trend Max. Y-Axis Max 80.1-110.0 in steps 110.0 The upper limit a measurement (°F)
  • Page 59 Root NIBPT Chapter 3: Operation Additional Settings for Temperature From the Temperature screen, touch Additional Settings, and then change any of the following options: Factory User Options Description Default Configurable Settings Settings Unit of The unit of measure for temperature.
  • Page 60 Root NIBPT Chapter 3: Operation NIBP The NIBP menu allows the user to view and customize settings for the NIBP module by changing any of the following options: Parameter Settings See Parameter Settings for NIBP on page 58. Intervals See Intervals for NIBP on page 61.
  • Page 61 Root NIBPT Chapter 3: Operation Systolic/Diastolic (SYS/DIA) From the Systolic/Diastolic screen, touch Alarms, and then change any of the following options: Factory Alarm Configurable Options Description Default Priority Options Settings 42-259 in steps of 1, The High Limit is upper...
  • Page 62 Root NIBPT Chapter 3: Operation Trends for NIBP From the Systolic/Diastolic screen, touch Trends, and then change any of the following options: Factory Default Configurable Options Description Settings Options The NIBP Trend Max. Y-Axis 21-260 in steps of 1 The upper limit a measurement will be shown.
  • Page 63 Root NIBPT Chapter 3: Operation Mean Arterial Pressure (MAP) From the Mean Arterial Pressure screen, touch Alarms, and then change any of the following options: Factory Alarm Configurable Options Description Default Priority Options Settings 28-219 in steps of 1, The High Limit is upper...
  • Page 64 Interval : Note: Schedule mode is Schedule once every defined Duration configured in Root by interval for the defined authorized personnel. duration. See Set Mode: Up to five (5) uniquely Schedule on page 101. defined Interval : Duration pairs can be stored.
  • Page 65 Root NIBPT Chapter 3: Operation Calibration for NIBP The Calibration option on the NIBP menu allows a qualified service professional to access calibration settings and tools for the NIBP module. For more information, see NIBP Module Calibration Test on page 150.
  • Page 66 Root NIBPT 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 65. Kite See Kite on page 66 Wi-Fi See Wi-Fi on page 66.
  • Page 67 Root NIBPT Chapter 3: Operation Device Output See Device Output on page 72. 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.
  • Page 68 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 34.
  • Page 69 Main Screen on page 33. 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.
  • Page 70 Operator's Manual. Root Battery Use the Root Battery screen to view the specific percentage of charge on the battery. The user can also access Root's Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 34.
  • Page 71 Description State of Charge Provides a read-only display of battery level remaining. Battery Diagnostics Allows trained personnel to access battery diagnostic information. Brightness Use the Brightness screen to adjust the brightness of the Root display. Option Description Factory Configurable Default...
  • Page 72 Root NIBPT Chapter 3: Operation Access Control Access Control contains configurable options and settings that require a password. To enter Access Control Press the key. When the numeric screen displays, enter the following numbers: 6 2 7 4 Asterisks (****) will be displayed.
  • Page 73 30 sec 3 min, 5 min, 10 5 min, 10 min, or 15 min, as Interval min, 15 min, or Off well as Off. Allows for Root software to Allow Unsigned be reverted back to older On or Off Upgrade version...
  • Page 74 Factory Defaults Options are restored to Press Restore. factory value. *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.
  • Page 75 IntelliBridge connectivity allows Root to transmit parameters and waveforms to Philips multi-parameter patient monitors that support Philips IntelliBridge device interfacing modules. This option allows parameters and waveforms on Root to be displayed on a Philips monitor and, if applicable, transmitted to the electronic medical record system.
  • Page 76 EtSEV, FiSEV, MAC 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.
  • Page 77 Profile type. 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.
  • Page 78 Root NIBPT Chapter 3: Operation Root has the ability to support up to eight (8) custom profiles to accommodate usage in any hospital environment. For more information regarding Profiles, see the Instructions for Use or Operator’s Manuals for Radical-7, Radius-7, and appropriate MOC-9 module(s).

  • Page 79: Alarm Interface

    Root NIBPT Chapter 3: Operation Alarm Interface Alarms can have different priority levels and come from different sources. The following tables describe alarm behaviors in more detail. Priority Alarm Sound High 10-pulse burst Medium 3-pulse burst Alarm Example Explanation Source...
  • Page 80 System The example shown here is a "Low Level 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). 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.

  • Page 81: Alarm Silence

    Root NIBPT Chapter 3: Operation Alarm Silence The Alarm Silence icon is an indicator as well as a functional button. It always indicates the presence of alarms, and it can be used to temporarily suspend audible alarms for a pre-configured amount of time, known as Silence Duration.
  • Page 82 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 34.

  • Page 83: Trend Download

    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.

  • Page 84: Session Management

    Action Bar. Session Name window will open in which you can label the session. When data is downloaded from Root it can be identified by the label assigned to a particular session. See About the Action Bar on page 36.

  • Page 85: Screen Capture

    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.
  • Page 86 Root NIBPT Chapter 3: Operation A confirmation flash will appear on the screen indicating a capture is in progress. A status message [1] will be displayed briefly at the top of the screen and the patient label name will be masked with asterisks [2].
  • Page 87 “screen_shot” in the USB drive with a FAT or FAT32 system file to enable the download of the screen captures. Plug the USB drive into the USB port located on the rear panel of Root; the screen captures will automatically download. A status message will display briefly at the top of the Root screen to indicate the start of the download.

  • Page 88: Lights

    Medium Service required High 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. Root is not connected to an AC power source.
  • Page 89 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.
  • Page 90 Root NIBPT 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 (1) audible tone Sleep sounds.

  • Page 91: Chapter 4: Temperature Measurement

    Note: This feature is optional on Root. For temperature measurements obtained with the TIR-1 bluetooth thermometer, refer to the TIR-1 manual. Root offers an optional integrated temperature module and takes a temperature measurement through the use of a temperature probe. The temperature probe is designed for use on adult and pediatric patients.
  • Page 92 Root NIBPT Chapter 4: Temperature Measurement Select Additional Settings , then select the desired measurement site through Probe Mode. The measurement site can also be changed using the action menu. Remove the temperature probe from the probe well holder to initiate spot check.

  • Page 93: Temperature Probes

    Dock the temperature probe in the probe well holder to end temperature monitoring. Temperature Probes Two types of probes are available for use with the Root: an oral/axillary probe and a rectal probe. Root will automatically detect the probe type when connected: oral/axillary or rectal.
  • Page 94 Regularly wipe the probe with a cloth dampened with warm water and a mild detergent solution, a 70% isopropyl alcohol solution, or a 10% chlorine bleach solution. Supported Masimo Probes and Probe Covers For a list of compatible temperature probes and accessories, visit http://www.masimo.com/. www.masimo.com Masimo...

  • Page 95: Chapter 5: Nibp Measurement

    Neonatal 140 mmHg Cuff Selection and Placement Root uses a bayonet hose with a blood pressure cuff to measure NIBP. For a list of compatible NIBP patient hoses and cuffs, visit http://www.masimo.com/. To ensure the correct cuff size Wrap the cuff around the arm.

  • Page 96: Patient Conditions

    Root NIBPT Chapter 5: NIBP Measurement To place cuff on the measurement site Wrap the cuff around the non-dominant arm, making sure that the Artery Marker is aligned over the brachial artery as shown in the image below. To locate the brachial artery, place the pads of your index and middle fingers halfway between the shoulder and elbow, in the middle of the inner arm, between the bicep and triceps muscles.

  • Page 97: Operation - Nibp

    To spot check measure NIBP Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. Note: The Patient Category determines the initial inflation pressure of NIBP.
  • Page 98 Root NIBPT Chapter 5: NIBP Measurement Press the Start button to begin measurement. Wait for measurement to complete or press the Stop button to stop measurement. Note: Measuring status displayed in the status bar. Wait for measurement values to appear to ensure that spot check is complete.
  • Page 99 To measure blood pressure in Automatic interval mode Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. To change the patient profile, press the Main Menu icon , then select Profiles Press the Profile Name to select the desired patient profile.
  • Page 100 Root NIBPT Chapter 5: NIBP Measurement On the Intervals screen, change Set Mode to Automatic, and then select the desired Interval. The set mode can also be changed using the action menu. WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference.
  • Page 101 To measure blood pressure in Stat interval mode Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. To change the patient profile, press the Main Menu icon , then select Profiles Press the Profile Name to select the desired patient profile.
  • Page 102 Root NIBPT Chapter 5: NIBP Measurement WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. To begin measurement, press the Start Stat button and then press the arrow at the top-left corner of the touchscreen to return to the Main View.
  • Page 103 To measure blood pressure in Schedule mode: Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. To change the patient profile, press the Main Menu icon , then select Profiles Press the Profile Name to select the desired patient profile.
  • Page 104 Root NIBPT Chapter 5: NIBP Measurement Press the Start Schedule button. Press the arrow at the top-left corner of the touchscreen to return to the Main View. Wait for the interval measurement to complete or press the Stop button to stop the interval measurement.

  • Page 105: Chapter 6: Admit And Discharge To Patient Safetynet

    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.

  • Page 106: Admitting A Patient

    Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Admitting a Patient To admit a patient: Press the admit icon on the bottom-left of the main screen. Enter the authentication PIN. Either press the patient info search button (1) to select existing patient information, or enter new patient information in the data fields (2).

  • Page 107: Discharging A Patient

    Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Discharging a Patient To discharge a patient: Press the discharge icon on the bottom-left of the main screen. Enter the authentication PIN. Press the Discharge button. A confirmation message will appear.

  • Page 108: 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.

  • Page 109: Monitoring Resumed Message

    When the sensor is taken off and placed back onto a patient, a Monitoring Resumed message will appear on the Root screen. If this is a new patient, press Discharge on the screen to discharge the previous patient. If the same patient is being monitored, press Confirm to continue monitoring the same patient.

  • Page 111: Chapter 7: Electronic Medical Record (Emr) Push

    Root main screen when the EMR Push feature is active. The EMR Push feature is active when a Root patient profile is connected to a Patient SafetyNet server. If the EMR Push icon does not appear, see Masimo Technical Services on page 160.

  • Page 112: Sending Patient Data To The Emr

    Press OK. Note: Username and PIN requirements are enabled through Patient SafetyNet. If unable to authenticate a username and PIN, see Masimo Technical Services on page 160. In the EMR Push screen, review and manually enter patient data before submitting to the EMR.

  • Page 113: Chapter 8: Radical-7

    (SpOC), methemoglobin (SpMet), pleth variability index (PVi), and/or acoustic respiration rate (RRa). It can be docked to Root to transfer parameter data to Root. When Radical-7 is docked to Root, the device automatically creates a Window that displays all the data from Radical-7.

  • Page 115: Chapter 9: Radius-7

    Root. When Radius-7 is connected to Root via Bluetooth, the device automatically creates a Window that displays all the data from Radius-7. Root also acts as a charging station for Radius-7. Radius-7 is docked onto Root via a Battery Charging Adapter. See Radius-7 Operator's Manual for more information.

  • Page 117: Chapter 10: Moc-9

    SedLine, ISA Capnography, and third-party technologies in an all-in-one view on Root. When any MOC-9 module is connected, Root automatically creates a Window that displays all the data from that module. The example below shows the “SedLine” and “Capnography”...

  • Page 119: Chapter 11: Iris

    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.

  • Page 120: Using Iris Connectivity Ports

    Electronic Health Records system Using Iris Connectivity Ports Use Iris Adapters and RJ-45 cables to connect standalone devices to Root. To connect a standalone device via an Iris Connectivity Port: Connect the Iris Adapter to the standalone device. Refer to the Iris Adapter Directions for Use.

  • Page 121: Iris Icon

    Connect to Server yellow square Patient SafetyNet or Connectivity Gateway. No standalone device is connected to Root and Root is not connected to a Disconnected White border Patient SafetyNet or Connectivity Gateway. Note: Status and connection type are read-only and not configurable by the user. For more information about Iris connectivity, see the Operator’s Manual for the appropriate version of...

  • Page 122: Iris Screen

    Connectivity Connection Description of Connection Status Message Status Color • Green tile Standalone device is successfully connected to Root, border Connected and Root is successfully connected to Patient • Green SafetyNet or Iris Gateway. indicator www.masimo.com...
  • Page 123 Status Message Status Color • Yellow tile Standalone device is connected to Iris adapter in border Connecting to Iris Root, but Root is attempting or unable to connect to Server • Yellow Patient SafetyNet or Iris Gateway. indicator • No color...

  • Page 125: Chapter 12: Bluetooth Devices

    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.

  • Page 127: Chapter 13: Messages

    Chapter 13: Messages The following messages are specific to Root: Message Explanation Next Step The internal battery needs to be Battery Charge is charged. System Status Lights Charge Root's battery using AC power. Low. flash yellow. MOC-9 module Reconnect module or acknowledge...
  • Page 128 Root NIBPT Chapter 13: Messages Message Explanation Next Step Verify patient temperature is not outside of the measurement range. Verify ambient temperature does not Patient or environmental exceed operating specification. Temperature Out temperature conditions may be of Range too low for a temperature If conditions are valid and problem measurement.
  • Page 129 Root NIBPT Chapter 13: Messages Message Explanation Next Step Perform calibration procedures per Blood pressure measurement User Manual. Calibration transducer may be out of range Required or there has been a calibration If problem still persists, contact data failure. Customer Service.

  • Page 131: Chapter 14: Troubleshooting

    Correction Power Button not pressed long enough. Press Power Button for two (2) seconds. The battery may be Connect Root to AC power to charge battery. Root does not turn on. depleted. One of the fuses is Replace the fuse. See Replacing the Fuses on not operating page 149.
  • Page 132 (8) seconds. If alarm continues to Internal failure. speaker tone. sound, Power Off Root. Root requires service. See Return Procedure on page 160. To Power On when turned off or in Sleep Mode, press Power Button for two (2) Power Button may seconds.
  • Page 133 Root NIBPT Chapter 14: Troubleshooting Symptom Possible Cause Correction Parameter is not Unable to manually configured for enter parameter data See Masimo Technical Services on page 160. manual entry on in EMR Push screen. Patient SafetyNet. www.masimo.com Masimo...

  • Page 135: Chapter 15: Specifications

    Chapter 15: Specifications This chapter contains specifications of Root. For information on the specifications of Radical-7, Radius-7, MOC-9 modules, and standalone devices, see Directions for Use or Operator's Manuals for these devices. Measurement Accuracy NIBP Pressure Transducer Between 0 mmHg and 300 mmHg ±3mmHg...

  • Page 136: Alarms

    Root NIBPT Chapter 15: Specifications Alarms Audio Alarm System Status Audio Description Type Light Color High Priority Flashing Red 10-pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s Medium Flashing Yellow 3-pulse burst, pulse spacing: 0.375s, 0.375s, repeat Priority...

  • Page 137: Display Ranges

    Root NIBPT Chapter 15: Specifications Display Ranges NIBP Patient Population Measurement Display Range Adult Systolic 40-260 mmHg Diastolic 20-200 mmHg 26-220 mmHg Pediatric Systolic 40-230 mmHg Diastolic 20-160 mmHg 26-183 mmHg Neonatal Systolic 40-130 mmHg Diastolic 20-100 mmHg 26-110 mmHg...

  • Page 138: Nibp Pressurization Ranges

    Root NIBPT Chapter 15: Specifications NIBP Pressurization Ranges Weight Patient Initial Maximum Category Pressurization Pressure Greater than 75 lbs (34 kg) Adult 160 mmHg 280 mmHg Between 15.4 - 75 lbs (7 - 34 Pediatric 140 mmHg 280 mmHg Less than 15.4 lbs (7 kg)

  • Page 139: Touchscreen Display

    Root NIBPT Chapter 15: Specifications Root Storage Humidity 10% to 95%, non-condensing 500 mbar to 1060 mbar Operating Air Pressure -1000 ft to 18,000 ft (-304 m to 5,486 m) Touchscreen Display Characteristic Description Type Backlit Active Matrix TFT LCD...
  • Page 140 Root NIBPT Chapter 15: Specifications Communication (Wi-Fi) 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.

  • Page 141: Compliance

    Root NIBPT Chapter 15: Specifications Radio Compliance FCC ID: VKF-RDS7A Model - RDS-7A Canada IC:7362A-RDS7A IC Model: RDS-7A RSS-210 Europe EN 300 328 EN 301 893 EN 301 489-1 EN 301 489-17 R & TTE Directive Compliance Electrical Safety ANSI/AAMI ES 60601-1:2005 CAN/CSA C22.2 No.
  • Page 142 Root NIBPT Chapter 15: Specifications NIBP Module Standards AAMI SP10:2002 ISO 81060-2:2009 EN 1060-1:1996 +A2:2009 EN 1060-3:1997 +A2:2009 EN 1060-4:2004 EMC Compliance EN 60601-1-2, Class A Equipment Classification per IEC 60601-1 Type of Protection Class I (on AC power) Internally powered (on battery power)

  • Page 143: Guidance And Manufacturer's Declaration-Electromagnetic Emissions

    Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Emissions Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.

  • Page 144: Guidance And Manufacturer's Declaration-Electromagnetic Immunity

    100% for 0.5 Mains power quality should be that interruptions and cycle of a typical commercial or hospital voltage variations on environment. Root provides a 60% for 5 power supply input battery for continued operation cycles lines. during power mains interruption for a maximum of 4 hours.
  • Page 145 Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Portable and mobile RF communications equipment should be used no closer to any part of the ME Equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 146: Recommended Separation Distances

    Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.

  • Page 147: Symbols

    Root NIBPT Chapter 15: 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.
  • Page 148 Root NIBPT Chapter 15: Specifications Symbol Description Symbol Description Index Line Non-Sterile Separate collection for Authorized representative electrical and electronic in the European community equipment (WEEE) Caution: Federal (USA) law restricts this device to sale Recyclable by or on the order of a...
  • Page 149 Root NIBPT Chapter 15: Specifications Symbol Description Symbol Description Date of manufacture Masimo reference number YYYY-MM-DD Storage temperature range Serial number Keep dry Fragile, handle with care Do not use if package is Storage humidity limitation damaged Atmospheric pressure Equipotential Ground...
  • Page 150 Root NIBPT Chapter 15: Specifications Symbol Description Symbol Description The names and content of the toxic and hazardous substances or elements shall be provided in the product instruction manual Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available for CE mark countries.

  • Page 151: Chapter 16: Service And Maintenance

    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: •...

  • Page 152: Power-On Self Test

    Power-On Self Test To conduct a Power-On Self Test Connect Root to AC power, and verify that the AC Power Indicator is illuminated. Power On Root. Within five (5) seconds, all available indicators will illuminate, the device will emit a tone, and the Masimo logo will display.
  • Page 153 • Set the unit of measurement to mmHg. • Verify the manometer has been calibrated. Power ON the Root. On the Root home screen, press the Main Menu icon Press NIBP Press CALIBRATION • For the password, enter 4258. •...

  • Page 154: Zero Point Calibration

    Span Point Calibration. See Zero Point Calibration on page 152 and Span Point Calibration on page 153. If the NIBP module pressure and manometer pressure still differ BEYOND the ±3mmHg tolerance, contact Masimo Technical Services. See Masimo Technical Services on page 160.

  • Page 155: Span Point Calibration

    If a "Result Failure" message appears, repeat the test by applying 250mmHg to the NIBP module and pressing Calibrate. If the "Result Failure" message is repetitive, contact Masimo Technical Services. See Masimo Technical Services on page 160. After successful Span Point Calibration, press the back button to go back to the CALIBRATION menu screen.

  • Page 156: Nibp Air Leak Test

    Root NIBPT Chapter 16: Service and Maintenance NIBP Air Leak Test Note: This section is provided as a reference and intended for authorized service personnel only. Pass Criteria International standards for automated NIBP devices require that air leakage within the pneumatic system must not exceed 6mmHg/minute.
  • Page 157 • Set the unit of measurement to mmHg. • Verify the manometer has been calibrated. Power ON the Root. On the Root home screen, press the Main Menu icon Press NIBP Press CALIBRATION • For the password, enter 4258. •...

  • Page 158: Overpressure Test

    (tubing, 500mL container, arm cuff, etc.). If there are no leaks detected from the calibration equipment and the leak rate is still greater than 6mmHg, contact Masimo Technical Services. See Masimo Technical Services on page 160.
  • Page 159 • Set the unit of measurement to mmHg. • Verify the manometer has been calibrated. Power ON the Root. On the Root home screen, press the Main Menu icon Press NIBP Press CALIBRATION • For the password, enter 4258. •...
  • Page 160 Note: If using a cuff, verify the cuff is Neonate. Do not use an Adult or Pediatric cuff for this test method. On the Root Main Screen, touch the Profiles option in the Status Bar. See About the Status Bar on page 34.

  • Page 161: Nurse Call Setting Connections

    If the valves opened BEYOND the overpressure point pass criteria, then press the Test button again to confirm the overpressure point. If the valves open repetitively beyond the pass criteria,contact Masimo Technical Services. See Masimo Technical Services on page 160.

  • Page 162: Battery Test

    Verify that the Root Charging Indicator is illuminated. When Root is fully charged, the Root Charging Indicator turns off. Power On Root and verify that the Root Battery Indicator icon on the Status Bar shows a full charge. Repair Policy Masimo or an authorized Service Department must perform warranty repair and service.

  • Page 163: Contacting Masimo

    12 months and any batteries for six (6) months from the original date the Product was obtained by the end-user purchaser. Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any defective Product or software media that is covered under the warranty.
  • Page 164 Root NIBPT Chapter 16: Service and Maintenance loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software. The above limitations do not preclude any liability that cannot legally be disclaimed by contract.

  • Page 165: Appendix: Concepts Of Alarm Response Delay

    The graphic does not reflect actual lengths of delays. Reference Definition Alarm Limit Displayed SpO Alarm Signal Generation Saturation Time The Alarm Condition Delay is graphically represented as t – t in the figure above to show the delay due to processing and averaging. www.masimo.com Masimo...
  • Page 166 Root NIBPT Appendix: Concepts of Alarm Response Delay The Alarm Signal Generation Delay is graphically represented as t – t in the figure above to show the delay due to alarm system strategy and communication time. The overall alarm system delay time is graphically represented as t –...

  • Page 167: Index

    Chapter 9 Battery Test • 160 Radius-7 • 113 Bluetooth • 35, 64, 68, 123 Cleaning • 149, 160 Bluetooth Devices • 31 Cleaning and Service Warnings and Brightness • 64, 69, 129 Cautions • 18 Compliance • 139 www.masimo.com Masimo...
  • Page 168 Compliance Warnings and Cautions • 19 Concepts of Alarm Response Delay • 163 Indications for Use • 9 Connect Device to Root • 123 Initial Battery Charging • 25, 27 Connecting Root to Patient SafetyNet • IntelliBridge Connectivity • 73 Intended Use •...
  • Page 169 Not Monitoring Message • 106 Return Procedure • 25, 129, 130, 160 Nurse Call Connection • 30 Root Battery • 27, 64, 68 Nurse Call Setting Connections • 130, Root Charging Indicator • 35, 87 Nurse Call Specifications • 134 Safety Information, Warnings, and Cautions •...
  • Page 170 Trends for NIBP • 60 Trends for Temperature • 55, 56 Troubleshooting Radical-7, Radius-7, and MOC-9 Modules • 129 Troubleshooting Root • 129 Understanding Windows • 41 Unpacking and Inspection • 25 Using Analog View • 42, 44 Using Iris Connectivity Ports • 118 Using MOC-9 Ports •...
  • Page 172 38280/LAB-9274G-0818...

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