Operator's Manual Root® with noninvasive blood pressure and temperature
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 Conforms to ANSI/AAMI ES 60601-1, CAN/CSA C22.2 No.
© 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 ---------------------------------------------------------- 17 Safety Information, Warnings, and C
Root NIBPT Contents Radius-7 Connection ----------------------------------------------------- 46 MOC-9 Connection ------------------------------------------------------- 47 Nurse Call Connection---------------------------------------------------- 48 Attach the Probe Well ---------------------------------------------------- 48 Attach the Temperature Probe ------------------------------------------- 49 Attach NIBP Cuff ---------------------------------------------------------- 49 Masimo Kite ---------------
Root NIBPT Contents Chapter 4: Temperature Measurement ----------------------------------- 141 Operation - Temperature ----------------------------------------------- 141 Temperature Probes ---------------------------------------------------- 145 Chapter 5: NIBP Measurement -------------------------------------------- 149 Patient Measurement Mode -------------------------------------------- 149 Cuff Selection and Placement ------------------------------------------ 149 Patient Conditions -----------------
Root NIBPT Contents Using MOC-9 Ports ----------------------------------------------------- 182 Chapter 11: Iris ------------------------------------------------------------ 183 Using Iris Connectivity Ports ------------------------------------------- 185 Iris Icon------------------------------------------------------------------ 186 Iris Screen --------------------------------------------------------------- 188 Chapter 12: Bluetooth Devices-------------------------------------------- 191 Connect Device t
Root NIBPT Contents Wireless Specifications -------------------------------------------------- 209 Compliance-------------------------------------------------------------- 212 Guidance and Manufacturer's Declaration-Electromagnetic Emissions215 Guidance and Manufacturer's Declaration-Electromagnetic Immunity 217 Recommended Separation Distances ---------------------------------- 221 Symbols ----------------------------------------------------------------- 223 Chapter 16: Service and Maintenance ----------
Root NIBPT Contents Appendix: Concepts of Alarm Response Delay -------------------------- 253 Concepts of Alarm Response Delay ----------------------------------- 253 Index ----------------------------------------------------------------------- 255 www.masimo.
About This Manual This manual explains how to set up and use Root® with noninvasive blood pressure and temperature . Important safety information relating to general use of Root appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user.
Product Description and Features, Intended Use and Indications for Use Product Description and Features Root® with noninvasive blood pressure and temperature is a patient monitoring and connectivity platform. It offers multiple high-impact innovations for broad applications across the continuum of care. Instantly interpretable, high-visibility display of Masimo’s breakthrough SET® and rainbow® SET measurements. Intuitive, touchscreen navigation for easy and adaptable use in any hospital environment.
Root NIBPT Product Description and Features, Intended Use and Indications for Use For all prescribing information and instructions for use of the compatible medical devices that are connected to Root, see Operator’s Manual or Instructions for Use for the specific medical device. Intended Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.
Root NIBPT Product Description and Features, Intended Use and Indications for Use saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).
Root NIBPT Product Description and Features, Intended Use and Indications for Use ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances.
Root NIBPT Product Description and Features, Intended Use and Indications for Use Patient Population Approximate Age Range Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older Contraindication There are no contraindications. www.masimo.
Safety Information, Warnings, and Cautions CAUTION: Root is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. Refer to Operator's Manuals for ISA, Kite, Patient SafetyNet, Radical-7, Radius-7, TIR-1 and SedLine for additional safety information, warnings, and cautions.
Root NIBPT 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 NIBPT Safety Information, Warnings, and Cautions CAUTION: Equipment intended to be connected to signal input/signal output ports should comply with applicable electrical safety standards to further minimize the risk of electric shock. Only devices that have been configured to operate with Root may function properly when connected. CAUTION: Only use the AC power cable provided by Masimo. Using a different AC power cable could cause damage to Root.
Root NIBPT Safety Information, Warnings, and Cautions Noninvasive Blood Pressure WARNING: Frequently check the blood pressure monitoring site to ensure adequate circulation. WARNING: Only use Root in neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. WARNING: Neonatal blood pressure measurements must always use a three (3) meter hose in order to avoid overpressure error caused by lack of air volume within the overall pneumatic system.
Root NIBPT Safety Information, Warnings, and Cautions CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient. CAUTION: If the blood pressure cuff is on the same limb as monitoring equipment (i.e., pulse oximeter probe), the pressurization within the cuff can cause temporary loss of function of the monitoring equipment.
Root NIBPT Safety Information, Warnings, and Cautions Note: If a reliable spot check measurement cannot be made, the temperature module will automatically switch to continuous mode to make the measurement. Note: Verify the compatibility of the temperature probe and probe cover before use with Root. 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.
Root NIBPT Safety Information, Warnings, and Cautions CAUTION: Before using Root under high intensity surgical lights, confirm that the display settings allow for clear display of measurements. CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer. CAUTION: Do not place the Root on electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Root promptly after a Low Battery alarm may result in the device shutting down.
Root NIBPT Safety Information, Warnings, and Cautions CAUTION: The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, cellular telephones, wireless PC and tablets, pagers, RFID, MRI, electrically powered wheelchair, etc.
Root NIBPT Safety Information, Warnings, and Cautions Optional Integrated Temperature WARNING: The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. WARNING: Do not take axillary temperature through the patient's clothing, direct probe-cover-to-skin contact is required. CAUTION: Long-term continuous temperature monitoring, greater than 5 minutes, is not recommended. CAUTION: Ensure probe well is properly in place.
Root NIBPT Safety Information, Warnings, and Cautions CAUTION: Kite is not a primary display. Medical decisions should be made using data from the primary display of a device in conjunction with clinical signs and symptoms. Patient SafetyNet System Note: The wireless communication status between Root and Patient SafetyNet is displayed by Patient SafetyNet.
Root NIBPT Safety Information, Warnings, and Cautions CAUTION: An operator may only perform maintenance procedures specifically described in the manual. Refer servicing to qualified service personnel trained in the repair of this equipment. CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards.
Root NIBPT Safety Information, Warnings, and Cautions GHz and that these radars could cause interference and/or damage to LE-LAN devices. CAUTION: Consideration to the compliance of the IEC 60601-1-1 standard should be made when configuring Root as part of a Medical System. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. Note: Use Root in accordance with the Environmental Specifications section in the Operator's Manual.
Root NIBPT Safety Information, Warnings, and Cautions Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.
Chapter 1: Description Root can be used in the following ways: As a docking station and charger for Radical-7 and Radius-7 Battery Module. As a bedside monitoring display for parameters on Radical-7, Radius-7, and MOC-9 modules. As a bedside monitor for continuous or non-continuous NIBP and temperature. Note: Continuous Mode will take a measurement every one (1) second. As a connectivity gateway for standalone devices. Features Front View www.masimo.
Root NIBPT Ref. Feature Chapter 1: Description 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 NIBPT 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 NIBPT Ref. Feature 6 Contains the input connector for a hospital grade Module AC power cord and the fuse holder. Ground Connector 8 Description Power Entry Equipotential 7 Chapter 1: 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 NIBPT Chapter 1: Description Side Views Left Side Ref. Feature Right Side Description Provides an indication of system 1 System Status Lights messages and alarm priority. See System Status Lights on page 135. 2 Power Button 3 MOC-9 Ports (3) www.masimo.com Places Root in Power On, Sleep, and Power Off modes. Provide connectivity for MOC-9 modules.
Root NIBPT 4 NIBP Nib 5 Temperature Probe Port* 6 7 Chapter 1: Description Connection port for NIBP Hose. Allows connection of temperature probe to Root. Temperature Probe Well Provides dock for temperature probe Holder* when not measuring. Probe Covers Holder Holds extra probe covers for quick access. *This feature is optional on 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 NIBPT Chapter 2: Setting Up Charge Root's battery fully before use. See Initial Battery Charging on page 42. Root should not be operated outside the environmental conditions listed in the specifications section. See Environmental on page 208. www.masimo.
Root NIBPT Chapter 2: Setting Up 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. Once Root turns on, if no Radical-7, Radius-7, or MOC-9 module is connected, the Root display shows the following message: Please Connect a Device. The user is now able to connect Radical-7, Radius-7, and MOC-9 module. www.masimo.
Root NIBPT Chapter 2: Setting Up For information about Sleep Mode and Power Off, see Sleep and Power Off on page 138. Initial Battery Charging To charge the battery for the first time 1. Securely plug the AC power cord into power entry module. 2. Plug the hospital grade AC power cord into an AC power source. 3. Verify that Root's battery is charging by ensuring that the AC Power Indicator (1) is green and the Battery icon on the Status Bar (2) is solid green or has the charging symbol.
Root NIBPT Chapter 2: Setting Up 4. The Root Charging Indicator remains orange while the battery is charging and will illuminate green when Root is fully charged. See Root Battery on page 109 and About the Status Bar on page 53. See Safety Information, Warnings, and Cautions on page 19. www.masimo.
Root NIBPT Chapter 2: Setting Up Radical-7 Connection It is recommended that Root be powered on before performing the steps below. 1. Snap the Radical-7 into the Docking Station. 2. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to power it on. 3. When properly connected, the Radical-7 Charging Indicator light will illuminate. An illuminated Radical-7 Battery icon will also appear in the Status Bar. See About the Status Bar on page 53 4.
Root NIBPT www.masimo.
Root NIBPT 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 NIBPT 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 10: MOC-9 on page 181. www.masimo.
Root NIBPT Chapter 2: Setting Up Nurse Call Connection Use a Nurse Call connection cable to connect to a Nurse Call System. To connect to a Nurse Call System 1. Identify the Nurse Call connection end (1/4 inch round female connector) of the cable. 2. Insert the Nurse Call connection cable securely into the compatible port on Root. 3.
Root NIBPT Chapter 2: Setting Up Attach the Temperature Probe 1. Hold the temperature probe cable connector with the spring tab on the right and insert it into the probe port of the temperature module. 2. Push the cable connector into place until it clicks. 3. Place probe cover onto the temperature probe and dock in the probe well. Attach NIBP Cuff For a list of compatible NIBP patient hoses and cuffs, visit http://www.masimo.com/. 1. Attach an adapter to the end of the cuff hose (if necessary).
Root NIBPT Chapter 2: Setting Up To add Root to Kite to view parameter status, refer to the Masimo Kite Software Application Operator's Manual. Bluetooth Devices External devices can be connected to Root through Bluetooth. For more information about connecting an external device to Root through Bluetooth, see Chapter 12: Bluetooth Devices on page 191. www.masimo.
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 NIBPT 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, SedLine module (middle) showing brain function measurements. www.masimo.
Root NIBPT Ref. Feature 1 2 3 Status Bar Windows Action Bar Chapter 3: Operation Description Displays system status as well as icons that provide shortcuts to menu items or actions. See About the Status Bar on page 53. 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, EMR Push, Session Management, Manual Events and the Main Menu. See Accessing Main Menu Options on page 76.
Root NIBPT Ref. Feature Chapter 3: Operation Description Displays Audio Pause status and temporarily silences an 2 Audio Pause alarm event. See Audio Pause on page 126. Allows for patient monitoring to be temporarily 3 Standby suspended. Available when using Root with Radical-7 or Mode Radius-7. See Standby Mode on page 128. Provides access to the Device Output screen for activation or deactivation of nurse call functions, USB 4 Device port output formats, and IntelliBridge connection.
Root NIBPT Ref. Feature Chapter 3: Operation Description Provides access to the Wi-Fi screen. If this icon is visible, then wireless connectivity has been enabled. The icon 7 Wi-Fi also indicates signal strength and Patient SafetyNet connectivity. See Wi-Fi on page 105. Provides access to the Ethernet screen. If this icon is 8 Ethernet visible, then Ethernet connectivity has been enabled. See Ethernet on page 107. Provides access to the Iris screen.
Root NIBPT Ref. Feature Chapter 3: Operation Description Displays charging status for Root and provides access to 11 Root Battery the Battery Root screen. The example shows that the battery is currently charging. See Root Charging Indicator on page 137. Provides access to the Sounds screen to adjust alarm and 12 Sounds pulse tone volume. This icon does not indicate the actual volume level of the alarm and pulse tone. See Sounds on page 99.
Root NIBPT 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 165 Provides access to send measured or manually 2 EMR Push* entered patient parameter data. See Electronic Medical Record (EMR) Push on page 173.
Root NIBPT 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 NIBPT Chapter 3: Operation Below is a list of all the different types of controls available on Root and the various ways to interact with each type of control.
Root NIBPT Control Chapter 3: Operation Applicable Actions Description 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 tiles Press unfocused tile When open, scrolls tile into center (focused) position Press anywhere When open, col
Root NIBPT Chapter 3: Operation Control Applicable Actions Description Window Press parameter or When no parameter or measurement measurement alarm is present, opens parameter or measurement menu When parameter or measurement alarm is present, silences parameter or measurement alarm Press and hold Enables parameter and measurement drag and drop Well Press parameter or When no parameter or measurement measurement alarm is present, opens parameter or measurement menu When parameter or measureme
Root NIBPT Control Chapter 3: Operation Applicable Actions Description Press y-axis Opens parameter or measurement trend menu Trend Zoom Press '+' Increases time range Press '-' Decreases time range Press time label Resets time range to default Alarm Silence Press Silences all alarms icon Audio Pause Press Enables Audio Pause Press Opens relevant menu Press Exits menu, abandons any changes icon Other Status Bar icons Back Arrow www.masimo.
Root NIBPT Chapter 3: Operation Menu Navigation When navigating through menus and configuring settings, all changes must be confirmed by selecting OK. To cancel the changes, select Cancel. Any screen requiring selection of option(s) will time out after one (1) minute of inactivity and return to the Main Screen. To navigate to the previous screen, press the arrow at the top left corner of the touchscreen. To return to the Main Screen, at any time, press the Home Button at any time.
Root NIBPT 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 NIBPT Ref. Feature 1 Window Chapter 3: Operation 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.
Root NIBPT Ref. Feature Chapter 3: Operation Description (Available only in Analog View) Parameters and measurements are shown as Analog Gauges in Analog 4b Analog View. A parameter's Analog Gauge includes its Alarm Limits, Gauge Numeric Value, Parameter Label, as well as Alarming, Caution and Normal Ranges. See Using Analog View on page 68. 5 Well www.masimo.com Displays parameters and measurements which are not shown as Trend Displays or Analog Gauges.
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. Ref. Feature Description Indicates current viewing of the parameter or 1 Value Range measurement. Press to access the Trend menu where the minimum and maximum of the range can be modified. Displays parameter and measurement over a period 2 Trend Graph of time.
Root NIBPT www.masimo.
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. Analog View displays alarming and normal ranges of a parameter or measurement. These indicators can be used to alert clinicians to a patient's condition.
Root NIBPT Ref. Feature 2 Alarm Limits 3 Numeric Value Chapter 3: Operation Description Indicate high and low alarm limits for the parameter or measurement. Indicates current reading of the parameter or measurement. Parameter or 4 Measurement Indicates the name of the parameter or measurement. Label www.masimo.
Root NIBPT 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 NIBPT Quarter Circle www.masimo.
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. To expand a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it dims.
Root NIBPT Chapter 3: Operation Order Instruction Step 3 Release the Numeric Value. Minimizing a parameter or measurement Order Instruction Step 1 Press and hold the Numeric Value until it shrinks. Step 2 Drag the Numeric Value to the Well. Step 3 Release the Numeric Value. www.masimo.
Root NIBPT Chapter 3: Operation Manual Sizing of Windows Expanding and minimizing of windows can be performed from the Main Screen. www.masimo.
Root NIBPT Chapter 3: Operation Steps Instruction 1 Press and hold the header bar of the window to be resized to activate the feature. Window borders turn blue for all windows visible on the main screen. 2 Touch the up arrow to expand the selected window. 3 Touch the down arrow to minimize the selected window. Note: The selected window can also be resized by touching the bar with an up or down arrow and dragging to resize.
Root NIBPT Chapter 3: Operation Temperature See Temperature on page 84. NIBP See NIBP on page 90. Sounds See Sounds on page 99. Device Settings See Device Settings on page 102. About See About on page 119. Trend Settings See Trend Settings on page 120. Profiles See Profiles on page 121. Iris See Chapter 11: Iris on page 183. www.masimo.
Root NIBPT Chapter 3: Operation 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 78. Active Channels See Active Channels on page 80. Additional Settings See Additional Settings on page 81. www.masimo.
Root NIBPT Chapter 3: Operation Available Layouts From the Layout screen, touch Available Layouts. When a Radical-7 or Radius-7 is docked to Root and/or multiple MOC-9 modules are connected to Root, the user will have the option to select from several pre-configured layouts. The image below is an example of Available Layouts in Root with Radical-7 docked. www.masimo.
Root NIBPT Chapter 3: Operation Note: The rainbow window can be viewed on a Radical-7, using software v1.5.3.5 or greater, in several of the pre-configured layouts. Active Channels From the Layout screen, press Active Channels. www.masimo.
Root NIBPT Chapter 3: Operation In the Active Channels screen, Temperature and NIBP can be enabled to display on the Root main screen. Ref Option Description Factory User Default Configurable Settings Settings Enables/disables the 1 Temperature temperature window on enabled the Root main screen. Enables/disables the NIBP 2 NIBP window on the Root main enabled screen. www.masimo.
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 User Configurable Default Settings Settings Trend Controls the sizing of Trend Layout Displays. Analog Range Dynamic Controls Analog Range Setting. Fixed Fixed or Dynamic Fixed or Dynamic The following diagram and tables explain the differences between Fixed and Dynamic modes for a Trend View. www.masimo.
Root NIBPT 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 72. 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 NIBPT 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. Temperature The Temperature menu allows the user to view and customize settings for the Temperature module by changing any of the following options: Alarms See Alarms for Temperature on page 84. Trends See Trends for Temperature on page 86. Additional Settings See Additional Settings for Temperature on page 88.
Root NIBPT Chapter 3: Operation From the Temperature screen, touch Alarms, and then change any of the following options: Options Description Alarm Priority Factory Default Settings Configurable Options 80.20-109.9 in High Limit (°F) steps of 0.1, or The High Limit is upper threshold that Medium Off triggers an alarm. Off When set to Off, alarm is disabled 80.1-109.8 in Low Limit (°F) steps of 0.1, or Low Limit is the lower threshold that Medium Off triggers an alarm.
Root NIBPT Options Chapter 3: Operation Description Alarm Priority Factory Default Settings Configurable Options 80.20-109.9 in High Limit (°F) steps of 0.1, or The High Limit is upper threshold that Medium Off triggers an alarm. Off When set to Off, alarm is disabled Silence Duration Temporarily suspend audible alarms for a None period of time. www.masimo.
Root NIBPT Chapter 3: Operation Trends for Temperature From the Temperature screen, touch Trends, and then change any of the following options: Factory Options Description Default Settings Y-Axis Max (°F) Y-Axis Min (°F) Y-Axis Max (°C) Y-Axis Min (°C) The Temperature Trend Max. The upper limit a measurement will be 110.0 shown. The Temperature Trend Min. The lower limit a measurement will be 80.0 shown. The Temperature Trend Max. The upper limit a measurement will be 43.3 shown.
Root NIBPT www.masimo.
Root NIBPT Chapter 3: Operation Additional Settings for Temperature From the Temperature screen, touch Additional Settings, and then change any of the following options: Options Description Factory User Default Configurable Settings Settings °F °F, °C Unit of The unit of measure for Measure temperature. Probe Mode A patient-specific probe setting. Oral Oral, Adult Ax, Pediatric Ax Provides continuous temperature readings through a Continuous Mode direct measurement.
Root NIBPT www.masimo.
Root NIBPT Chapter 3: Operation NIBP The NIBP menu allows the user to view and customize settings for the NIBP module by changing any of the following options: Parameter Settings See Parameter Settings for NIBP on page 91. Intervals See Intervals for NIBP on page 96. Additional Settings See Additional Settings for NIBP on page 99. Calibration See Calibration for NIBP on page 99.
Root NIBPT Chapter 3: Operation Pulse Rate See Pulse Rate (PR) on page 94. Mean Arterial Pressure See Mean Arterial Pressure (MAP) on page 95. Systolic/Diastolic (SYS/DIA) From the Systolic/Diastolic screen, touch Alarms, and then change any of the following options: Options Systolic High Limit Systolic Low Limit Alarm Description Priority Factory Default Settings Options 42-259 in steps The High Limit is upper threshold that triggers an Medium 220 alarm.
Root NIBPT Options Systolic High Limit Diastolic High Limit Diastolic Low Limit Chapter 3: Operation Alarm Description Priority Factory Default Settings Options 42-259 in steps The High Limit is upper threshold that triggers an Medium 220 alarm. of 1, or Off When set to Off, alarm is disabled 22-199 in steps The High Limit is upper threshold that triggers an Medium 110 alarm.
Root NIBPT Chapter 3: Operation Trends for NIBP From the Systolic/Diastolic screen, touch Trends, and then change any of the following options: Factory Options Description Default Settings Y-Axis Max Y-Axis Min The NIBP Trend Max. The upper limit a measurement will be 260 shown. The NIBP Trend Min. The lower limit a measurement will be 20 shown.
Root NIBPT Chapter 3: Operation Alarm Options Description Priority Factory Default Settings Configurable Options 40-215 in steps High Limit of 5, or Off The High Limit is upper threshold that triggers an Medium 120 alarm. When set to Off, alarm is disabled 35-210 in steps Low Limit of 5, or Off Low Limit is the lower threshold that triggers an Medium 50 alarm.
Root NIBPT Chapter 3: Operation Alarm Options Description Priority Factory Default Settings Configurable Options 28-219 in steps High Limit of 1, or Off The High Limit is upper threshold that triggers an Medium 120 alarm. When set to Off, alarm is disabled 27-218 in steps Low Limit of 1, or Off Low Limit is the lower threshold that triggers an Medium 50 alarm.
Root NIBPT Chapter 3: Operation Factory Set Mode Description Configuration Default Settings User Configurable Settings Automatic interval measurement 2 min, 3 min, mode will take 4 min, 5 min, blood pressure Automatic measurements Interval 15 min once every defined 10 min, 15 min, 30 min, 60 min, 90 interval. See Set min Mode: Automatic on page 155.
Root NIBPT Chapter 3: Operation Factory Set Mode Description Configuration Default Settings User Configurable Settings Interval and Duration settings can be customized to accommodate Schedule a facilities measurement protocol. mode will take Note: blood pressure measurements Schedule once every defined interval for the Schedule Interval : Duration NA mode is configured in Root by defined duration. authorized See Set Mode: personnel. Up Schedule on page to five (5) 160.
Root NIBPT Chapter 3: Operation Additional Settings for NIBP From the NIBP screen, touch Additional Settings, and then change the following option: Options Measurement Timeout Description Factory User Default Configurable Settings Settings Defines the value of when the last BP reading values 15 min will clear the window.
Root NIBPT Chapter 3: Operation 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. volume Pulse Tone Sets the pulse tone volume Volume level. www.masimo.com Slide towards the left to decrease volume to silence. Slide towards the left to 3 decrease volume to silence.
Root NIBPT 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 that Audio the audible alarm remains Pause silenced, when Audio Duration Pause is enabled. See alarms when Audio Pause 2 minutes is enabled, but visual alarms will still display. If Permanent with Audio Pause on page 126.
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 103. Kite See Kite on page 104 Wi-Fi See Wi-Fi on page 105. Ethernet See Ethernet on page 107. Bluetooth See Bluetooth on page 108. Root Battery See Root Battery on page 109. www.masimo.
Root NIBPT Chapter 3: Operation Radical-7 Battery See Radical-7 and Radius-7 Battery on page 110. Brightness See Brightness on page 110. Access Control See Access Control on page 111. Device Output See Device Output on page 116. Localization Use the Localization screen to view the current date and time and configure settings related to local time, language and geography. The user can also access the Localization screen by pressing the current time on the Status Bar. See About the Status Bar on page 53.
Root NIBPT Option Chapter 3: Operation Description Factory Configurable Default Settings Setting Language Selects the language display for Root. Choose from English available languages. Date Sets the display format for Format current date. Time Sets the display format for Format current time. Line Sets to match regional Frequency power line frequency. Date Time mm/dd/yy 12 hour mm/dd/yy or dd/mm/yy 12 hour or 24 hour 60 Hz 50 Hz or 60 Hz Sets the current date.
Root NIBPT 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 an Connection active Kite connection. Pairing Key enabled(no key) disabled enabled (key) or disabled Four (4) digit code Automatic with automatically assigned for N/A active Kite active Kite session.
Root NIBPT Chapter 3: Operation Root uses only configured MAC addresses to establish wireless communications to prevent unauthorized connections to other wireless devices. As risk mitigation to the loss of the wireless communication, 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.
Root NIBPT Chapter 3: Operation Connecting Root to Patient SafetyNet Root can be configured to connect to Patient SafetyNet wirelessly by authorized and trained personnel only. The wireless icon in the Status Bar on Root displays the current connection status. See About the Main Screen on page 52. Icon Description A gray icon indicates Root wireless radio is on, but it is not connected to a wireless network.
Root NIBPT Option Ethernet Chapter 3: Operation Description Factory Default Configurable Enables or disables Ethernet connectivity. Setting Settings On On or Off Additional fields in the Ethernet screen display read-only settings about the Ethernet connectivity that cannot be configured by the user. Bluetooth The Bluetooth radio allows for the detection of the close proximity of Masimo’s MyView Presence Tag.
Root NIBPT Option Chapter 3: Operation Description Factory Configurable Default Settings Setting Bluetooth Enables or disables Bluetooth connectivity. Off On or Off For more information on how to configure MyView Presence Tag, see the Patient SafetyNet Operator's Manual. Root Battery Use the Root Battery screen to view the specific percentage of charge on the battery. The user can also access Root's Battery screen by pressing the Battery icon on the Status Bar.
Root NIBPT Chapter 3: Operation Radical-7 and Radius-7 Battery Use the Battery screen to view the specific percentage of charge on the Radical-7 or Radius-7's battery. For Radical-7, the user can also access the Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 53. Option Description State of Charge Provides a read-only display of battery level remaining. Battery Allows trained personnel to access battery diagnostic Diagnostics information.
Root NIBPT Option Chapter 3: Operation Description Factory Configurable Default Settings Setting Auto Brightness Allows automatic adjustment of Root's display brightness based on Off On or Off ambient light. Adjust the brightness level of the Brightness Root display by sliding the button (4 4 1, 2, 3, 4 is brightest). Access Control Access Control contains configurable options and settings that require a password. To enter Access Control www.masimo.
Root NIBPT Chapter 3: Operation 1. Press the key. 2. When the numeric screen displays, enter the following numbers: 6 2 74 Asterisks (****) will be displayed. To undo an entry, press Backspace. 3. Press Enter to access the password protected screen. Note: The password will have to be entered every time this screen is accessed. Option Description Factory Configurable Default Settings Setting Adult, Adult Power On Profile Sets the profile used when the device is powered on.
Root NIBPT Option Chapter 3: Operation Description Factory Configurable Default Settings Setting Enables or disables All Mute Enabled parameter Alarm Silence menu option. Off On or Off Off 3, 4, or Off See Sounds on page 99. Lock Alarm Sets the lowest alarm Volume volume level. Optical Enables or disables Sensor Off alarm delay when Alarm Delay Optical Sensor is off. 0 Sec. 0, 5, 10, 15, 30, or 60 seconds Enables or disables Standby option for Standby Enabled Mode.
Root NIBPT Option Chapter 3: Operation Description Factory Configurable Default Settings Setting Enables or disables Sessions Enabled Session Management.
Root NIBPT Option Chapter 3: Operation Description Factory Configurable Default Settings Setting Synchronized Enables or disables Waveforms Synchronization Enabled Waveform view. Presence Enables or disables Monitoring Presence Monitoring Off On or Off Off On or Off Saves current profile Press Save to Save as Adult parameter as the Adult N/A Save as Pediatric Save as Neo update the Profile. profile.
Root NIBPT Chapter 3: Operation Device Output The Device Output screen allows the user to configure additional data output options. A Nurse Call can be triggered based on alarm, low Signal IQ events or both. In addition, Nurse Call Polarity can be inverted to accommodate local Nurse Call station requirements. Option Description Factory Configurable Default Settings Setting Nurse Call Trigger Controls the source of monitoring which sets off Alarms the trigger.
Root NIBPT Option Chapter 3: Operation Description Factory Configurable Default Settings Setting USB Port 2 Controls the output type for USB Port 2. None, SatShare, IAP ASCII 1, IntelliBridge, or IAP Radical Radical Module A IntelliBridge Output Options* Controls the data type output for IntelliBridge. Radical SedLine Numerics only SedLine, O3 Sensor 1/2/L/R Capnography SedLine, O3 Sensor 1/2/3/4 *Displays when IntelliBridge is selected as USB Port Output.
Root NIBPT Chapter 3: Operation Root to be displayed on a Philips monitor and, if applicable, transmitted to the electronic medical record system. Masimo parameters from SET, rainbow SET, and SedLine, channels are supported. 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 NIBPT Chapter 3: Operation Parameters Supported IntelliBridge connectivity allows for up to six (6) parameters and two (2) waveforms or eight (8) parameters and no waveform to be displayed on Philips monitors.
Root NIBPT 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 NIBPT Option Chapter 3: Operation Description Factory Configurable Settings Default Setting Clear Delete all stored Trends trend data. 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). Profiles Use the Profiles screen to select patient type.
Root NIBPT Chapter 3: Operation settings on Root. The settings of the three default profiles (Adult, Pediatric, and Neonatal) configure parameter alarms, averaging time, and sensitivity modes. 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).
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 Source Example Explanation Parameter The example shown here is a PR Level alarm as the reading (61) exceeds the lower alarm limit (65).
Root NIBPT 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 "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).
Root NIBPT Chapter 3: Operation For more details about specific alarms on Radical-7, Radius-7, and MOC-9 modules, see Directions for Use or 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.
Root NIBPT www.masimo.
Root NIBPT 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 53. By default, Audio Pause is inactive, and the icon appears in the following way: Audio Pause inactive To activate Audio Pause, press the icon.
Root NIBPT 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 NIBPT Chapter 3: Operation Trend Download Root can store up to 96 hours of trend data captured at 2-second intervals from Radical-7, Radius-7, and MOC-9 modules. Trend data from Root can be transferred to a computer via USB for evaluation. Trend data is stored in non-volatile memory, so it is not erased when Root is shut off. Trend data download is initiated using the Masimo Instrument Configuration Tool, which converts the data to a .TXT or .CSV file. www.masimo.
Root NIBPT 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 NIBPT Chapter 3: Operation Screen Capture Up to 20 screen capture images can be stored in Root and transferred to a USB drive as PNG files. When the limit of 20 screen captures is reached in Root, every new screen capture will replace the oldest dated screen capture. Note: There must be a folder titled “screen_shot” in the USB drive with a FAT or FAT32 system file to enable the download of the screenshots. Capturing Screens To capture a screen: www.masimo.
Root NIBPT Chapter 3: Operation Swipe across the Root screen from right to left using two or more fingers simultaneously (see image below). www.masimo.
Root NIBPT Chapter 3: Operation A confirmation flash will appear on the screen indicating a capture is in progress. A status message [1] will be displayed briefly at the top of the screen and the patient label name will be masked with asterisks [2]. www.masimo.
Root NIBPT Chapter 3: Operation Reference Example Description The screen capture status message displays the following information: Date: Date of screen capture (YYYYMMDD) Time: Time of screen capture (HHMMSS) Device Serial Number: 10 digit Root serial number 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 NIBPT Chapter 3: Operation Downloading Screen Captures To download screen captures: 1. Remove any sensors connected to the patient to stop monitoring, and acknowledge any alarms triggered on Root. Note: Before connecting the USB drive in the next step, there must be a folder titled “screen_shot” in the USB drive with a FAT or FAT32 system file to enable the download of the screen captures. 2.
Root NIBPT Chapter 3: Operation System Status Light Light Status Alarm Priority Indication None None Monitoring has not started. Green None There is currently no active alarms. Flashing Yellow Medium There is an active alarm of medium priority. Flashing Red There is an active alarm of high priority. High The alarm priority is determined by the Radical-7, Radius-7, and MOC-9 module(s) that are connected to Root.
Root NIBPT Chapter 3: Operation 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. Off Battery is not being charged. Root is not connected to AC power source.
Root NIBPT Chapter 3: Operation When Root is connected to an AC power source, it is able to charge a correctly docked Radical-7 or Radius-7. This is true whether the device is powered on, in Sleep Mode, or powered off. Conversely, when Root is not connected to AC power, it will not charge the device. The light status provides a visual indication of the battery condition: Light Status Battery Indication Green Battery is fully charged. Orange Battery is charging. Red Battery is unable to charge.
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) Sleep 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 (2) Power Off Mode audible tones sound. The Home Button will flash, and the Power Button will flash orange.
Chapter 4: Temperature Measurement Note: This feature is optional on Root. For temperature measurements obtained with the TIR-1 bluetooth thermometer, refer to the TIR-1 manual. Root offers an optional integrated temperature module and takes a temperature measurement through the use of a temperature probe. The temperature probe is designed for use on adult and pediatric patients. Patient temperature can be measured via an oral/axillary or rectal probe.
Root NIBPT Chapter 4: Temperature Measurement Taking Temperature Measurement 1. Ensure that the correct measurement site is selected before measurement. Note: If a rectal probe is attached, the Site button will not appear. Note: The site selection toggle is disabled once the probe has been placed on the site. The toggle will be re-enabled once the probe has been returned to the probe well holder. 2.
Root NIBPT 3. Chapter 4: Temperature Measurement Remove the temperature probe from the probe well holder to initiate spot check. Note: Ready status will display in the status bar and sound will play. 4. Apply a single-use disposable probe cover to the temperature probe before measurement. WARNING: The use of any other probe cover may produce temperature measurement errors or may result in inaccurate readings. 5. Place the temperature probe on the site to begin spot check.
Root NIBPT 6. Chapter 4: Temperature Measurement Wait for measurement to complete or return the probe to stop measurement. Note: If a reliable spot check measurement cannot be made, the temperature module will automatically switch to continuous mode to make the measurement. Note: Once measurement is successfully completed, value is displayed. If continuous monitoring is not needed, dock the temperature probe in the probe well holder to reset measurement. 7.
Root NIBPT Chapter 4: Temperature Measurement Temperature Probes Two types of probes are available for use with the Root: an oral/axillary probe and a rectal probe. Root will automatically detect the probe type when connected: oral/axillary or rectal. Adult axillary Spot Check Mode (predictive) temperatures are measured using the oral/axillary probe in combination with the Root in Adult axillary mode. A temperature reading is provided in approximately 12-15 seconds.
Root NIBPT Chapter 4: Temperature Measurement possible in the axilla. Do not allow the probe tip to come into contact with the patient until the probe is placed in the measurement site. Any prior contact between the probe tip and the tissue with another material may cause inaccurate readings. Verify that axillary tissue completely surrounds the probe tip and place the arm snugly at the patient's side.
Root NIBPT Chapter 4: Temperature Measurement Supported Masimo Probes and Probe Covers For a list of compatible temperature probes and accessories, visit http://www.masimo.com/. www.masimo.
Chapter 5: NIBP Measurement Root provides noninvasive blood pressure readings through an oscillometric method. An oscillometric method of blood pressure measurement is a noninvasive method that monitors the amplitude of cuff pressure changes during cuff deflation to determine arterial blood pressure. The NIBP module is designed for use on adult, pediatric, and neonatal patients. Patient Measurement Mode Below is a table that provides a method for selecting the appropriate NIBP patient category.
Root NIBPT The index line Chapter 5: NIBP Measurement should align within the cuff range markings . If the index line does not fit within the range markings, select a larger or smaller cuff. www.masimo.
Root NIBPT Chapter 5: NIBP Measurement To place cuff on the measurement site Wrap the cuff around the non-dominant arm, making sure that the Artery Marker is aligned over the brachial artery as shown in the image below. To locate the brachial artery, place the pads of your index and middle fingers halfway between the shoulder and elbow, in the middle of the inner arm, between the bicep and triceps muscles. If possible, do not wrap the cuff over the patient’s clothing.
Root NIBPT Chapter 5: NIBP Measurement Patient is comfortably seated Patient's legs are uncrossed Patient's feet are flat on the floor Patient's back and arm are supported The middle of the cuff is at the level of the right atrium of the heart Blood pressure measurements can be affected by the patient's position, physiological condition, and environmental factors.
Root NIBPT Chapter 5: NIBP Measurement the diastolic pressure can be determined based upon the rapidly diminishing amplitude of the pressure fluctuations. Spot Check Measurement To spot check measure NIBP 1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. Note: The Patient Category determines the initial inflation pressure of NIBP.
Root NIBPT 3. Chapter 5: NIBP Measurement Properly place the blood pressure cuff on patient. See Cuff Selection and Placement on page 149. 4. Press the Start button to begin measurement. 5. Wait for measurement to complete or press the Stop button to stop measurement. Note: Measuring status displayed in the status bar. www.masimo.
Root NIBPT 6. Chapter 5: NIBP Measurement Wait for measurement values to appear to ensure that spot check is complete. www.masimo.
Root NIBPT Chapter 5: NIBP Measurement Set Mode: Automatic Automatic interval measurement mode will take blood pressure measurements once every desired interval. To measure blood pressure in Automatic interval mode 1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. 2. To change the patient profile, press the Main Menu icon select Profiles , then .
Root NIBPT 4. Chapter 5: NIBP Measurement To enable Automatic mode, press the Main Menu icon select NIBP Settings , then . On the Intervals screen, change Set Mode to Automatic, and then select the desired Interval. The set mode can also be changed using the action menu. WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. 5.
Root NIBPT Chapter 5: NIBP Measurement Note: Once finished measuring, values will appear and the next measurement will begin after the specified interval. Set Mode: Stat Stat interval measurement mode will take blood pressure measurements continuously for the desired duration. To measure blood pressure in Stat interval mode 1. Ensure that the correct patient profile is selected before measurement.
Root NIBPT Chapter 5: NIBP Measurement Press the Profile Name to select the desired patient profile. 3. Properly place the blood pressure cuff on patient. See Cuff Selection and Placement on page 149. 4. To enable Stat mode, press the Main Menu icon NIBP Settings , then select . On the Intervals screen, change Set Mode to Stat, and then select the desired Stat Duration. The set mode can also be changed using the action menu.
Root NIBPT 5. Chapter 5: NIBP Measurement 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. 6. Wait for measurement to complete or press the Stop button to stop the measurement. Note: Once measurement is completed and values appear, the next measurement will begin and repeat until duration time has elapsed.
Root NIBPT Chapter 5: NIBP Measurement *Schedules are configured by authorized personnel. To measure blood pressure in Schedule mode: 1. Ensure that the correct patient profile is selected before measurement. WARNING: Only use Root in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. 2. To change the patient profile, press the Main Menu icon select Profiles , then . 3. Press the Profile Name to select the desired patient profile. 4.
Root NIBPT Chapter 5: NIBP Measurement WARNING: Too frequent blood pressure measurements can cause injury to the patient due to blood flow interference. 7. Press the Start Schedule button. 8. Press the arrow at the top-left corner of the touchscreen to return to the Main View. 9. Wait for the interval measurement to complete or press the Stop button to stop the interval measurement. www.masimo.
Root NIBPT Chapter 5: NIBP Measurement After an interval measurement has completed and values appear, the next interval measurement will begin and repeat until the duration time has elapsed. www.masimo.
Chapter 6: Admit and Discharge to Patient SafetyNet The Admit/Discharge icon is located at the bottom left of the Main Screen and allows for clinicians to admit or discharge patient's on Masimo Patient SafetyNet directly from Root. Note: In order to use this feature Masimo Patient SafetyNet software version 5.0.1.0 or higher is required. www.masimo.
Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Not Admitted A Not Admitted message will appear on the Root screen when the sensor is placed onto a patient and a patient has not yet been admitted on the Root. Press the Admit button on the screen to admit the patient or press skip and the patient data will not be transmitted to the Masimo Patient Safety Net. www.masimo.
Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Admitting a Patient To admit a patient: 1. Press the admit icon on the bottom-left of the main screen. 2. Enter the authentication PIN. 3. Either press the patient info search button (1) to select existing patient information, or enter new patient information in the data fields (2). 4. Press the assignments search button (3) and select the primary and secondary pagers (4). www.masimo.
Root NIBPT 5. Chapter 6: 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. 2. Enter the authentication PIN. www.masimo.
Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet 3. Press the Discharge button. A confirmation message will appear. 4. Press the Discharge confirmation button. Note: Once patient is discharged from Root, or session is ended, the NIBP parameter display will be cleared. www.masimo.
Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Not Monitoring Message When the sensor is off the patient for an extended period of time, a Not Monitoring message will appear on the screen. Acknowledge the message by pressing Cancel or Discharge. Press Discharge to discharge the patient that is currently admitted on the Root, or press Cancel to keep the same patient admitted. www.masimo.
Root NIBPT Chapter 6: Admit and Discharge to Patient SafetyNet Monitoring Resumed Message When the sensor is taken off and placed back onto a patient, a Monitoring Resumed message will appear on the Root screen. If this is a new patient, press Discharge on the screen to discharge the previous patient. If the same patient is being monitored, press Confirm to continue monitoring the same patient. www.masimo.
Chapter 7: Electronic Medical Record (EMR) Push The Electronic Medical Record (EMR) Push feature allows clinicians to send validated patient vitals data from any of the Masimo devices, MOC-9 modules, or Iris devices connected to Root directly to a Patient Data Management System, such as an Electronic Medical Record (EMR). Determining EMR Push is Active The EMR Push icon appears at the bottom of the Root main screen when the EMR Push feature is active.
Root NIBPT 1. Chapter 7: 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 NIBPT Chapter 7: Electronic Medical Record (EMR) Push Sending Patient Data to the EMR Follow the instructions below to send patient data to a data management system using the EMR Push feature. Note: Parameters that appear on the EMR Push screen can be pre-configured on Patient SafetyNet. For questions about pre-configuring EMR Push parameters, see Masimo Technical Services on page 248. 1. Select the EMR Push icon at the bottom of the Root Main Screen. 2.
Root NIBPT 7. Chapter 7: Electronic Medical Record (EMR) Push Press OK in the Successfully Sent Data to EMR confirmation screen. www.masimo.
Chapter 8: Radical-7 The Radical-7 is a detachable portable noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi), along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), pleth variability index (PVi), and/or acoustic respiration rate (RRa). It can be docked to Root to transfer parameter data to Root.
Chapter 9: Radius-7 The Radius-7 is a patient wearable device for continuous monitoring when the patient is ambulatory. It measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi) along with optional measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), and/or acoustic respiration rate (RRa). It uses a Bluetooth connection to transfer parameter data to Root.
Chapter 10: MOC-9 Flexible measurement expansion is enabled through MOC-9. It can display parameters and measurements captured by SedLine, ISA Capnography, and third-party technologies in an all-in-one view on Root. When any MOC-9 module is connected, Root automatically creates a Window that displays all the data from that module.
Root NIBPT Chapter 10: 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 11: Iris Iris allows a variety of standalone devices to connect to Root. Patient data can be passed through Root to Patient SafetyNet or Connectivity Gateway, which can send the data to electronic health records. Below is an example of one way Root can be used in a network setting using Patient SafetyNet. Root receives and may display information from Radical-7, MOC-9 modules, as well as standalone devices. www.masimo.
Root NIBPT Chapter 11: Iris Ref. Description 1 Standalone devices connected via Iris (e.g., monitor, pump, ventilator) 2 Root 3 Patient SafetyNet View Station 4 Patient SafetyNet or Masimo Connectivity Gateway 5 Notification devices 6 Electronic Health Records system www.masimo.
Root NIBPT Chapter 11: Iris 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: 1. Connect the Iris Adapter to the standalone device. Refer to the Iris Adapter Directions for Use. 2. Connect the RJ-45 end of the Iris Adapter to any of the four (4) compatible Iris Connectivity Ports on Root using a RJ-45 cable. www.masimo.
Root NIBPT Chapter 11: Iris Iris Icon The Iris icon located in the Status Bar indicates Iris port connectivity status. See About the Status Bar on page 53. The Iris ports are mapped to the Iris icon according to the diagram below: Iris connectivity port status is indicated in the Iris icon by color and shape. See the table below for further description.
Root NIBPT Chapter 11: Iris Iris Port Connection Iris Icon Status Example Description of Description Connection No standalone device is connected to Root and Disconnected White border Root is not connected to a Patient SafetyNet or Connectivity Gateway. Note: Status and connection type are read-only and not configurable by the user. For more information about Iris connectivity, see the Operator’s Manual for the appropriate version of Masimo Patient SafetyNet. www.masimo.
Root NIBPT Chapter 11: 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 53. The Iris Screen displays 4 Iris port connectivity tiles. Each Iris port connectivity tile displays the [1] Iris port connectivity indicator and [2] device type, model, and Iris port connectivity status. The Iris port connectivity status is indicated by color and displayed message.
Root NIBPT Chapter 11: Iris 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. Yellow tile Standalone device is connected to Iris border adapter in Root, but Root is attempting Yellow or unable to connect to Patient indicator SafetyNet or Iris Gateway.
Chapter 12: Bluetooth Devices Flexible measurement expansion is possible through the Root Bluetooth connection. Root displays measurements captured by external device technologies in an all-in-one view on Root. When an external device is connected to Root via Bluetooth, Root automatically creates a window that displays all the data from that device on the Main Screen. Connect Device to Root Connect an external device to Root using Bluetooth 1. Ensure Bluetooth is enabled on Root.
Chapter 13: 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.
Root NIBPT Message Chapter 13: Messages Explanation Next Step contact Customer Service. An error has occurred in the Retake Measurement process of taking a patient Try another measurement temperature measurement cycle. If problem persists, with the optional integrated replace probe. temperature module. Verify ambient temperature Check Ambient Ambient temperature may Temperature be too high or too low. does not exceed operating specification. Check internal temperature at probe well.
Root NIBPT Message Chapter 13: Messages Explanation Next Step problem persists, replace probe. If problem still persists, contact Customer Service. Module Error Module communication error. Temperature Probe has been disconnected or is not responsive. Check Cuff (Weak Signal) If problem still persists, contact Customer Service. The optional integrated Connect Probe Power cycle the device. Weak or no signal measured during blood pressure measurement.
Root NIBPT Message Check Cuff (Pneumatic Blockage) Chapter 13: Messages Explanation Next Step Check that the cuff is not May be a blockage in the air leaking air. hose. If problem still persists, contact Customer Service. Check Cuff (Inflate Timeout) May be a blockage in the air hose. Check Cuff Weak Signal when (Safety measurement is being Timeout) taken. Check Cuff (Overpressure) Calibration Required May be due to a faulty cuff.
Chapter 14: Troubleshooting Troubleshooting Radical-7, Radius-7, and MOC-9 Modules For information on troubleshooting values that are provided from Radical-7, Radius-7, and MOC-9 modules, refer to their respective Instructions for Use or Operator's Manuals. Troubleshooting Root Symptom Possible Cause 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 NIBPT Symptom Chapter 14: Troubleshooting Possible Cause Correction Adjust the brightness setting. Root turns on, but See Brightness on page 110. 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 247. Touch functionality is not responsive. Root requires service. Contact Internal failure. Masimo Technical Services. See Return Procedure on page 247.
Root NIBPT Symptom Chapter 14: 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 NIBPT Symptom Chapter 14: 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 247. Unplug and replug AC power cable. disconnected. Root Charging Indicator Correction Internal failure. illuminates red. Root requires service. See Return Procedure on page 247. Unplug and replug Nurse Call Nurse Call does not communicate. Connection error. connector.
Root NIBPT Symptom Chapter 14: 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 248. screen. Patient SafetyNet. www.masimo.
Chapter 15: Specifications This chapter contains specifications of Root. For information on the specifications of Radical-7, Radius-7, MOC-9 modules, and standalone devices, see Directions for Use or Operator's Manuals for these devices. Measurement Accuracy NIBP Pressure Transducer Between 0 mmHg and 300 mmHg ±3mmHg Optional Integrated Temperature* Temperature Between 80°F and All patient populations ±0.2°F 110°F (26.7°C and (0.11°C)** 43.
Root NIBPT Chapter 15: Specifications Pediatric Axillary 117 -0.03 0.56 0.14 Adult Axillary 105 0.13 0.43 0.14 *Test Report #:2010036 Test Report of Clinical Investigation to demonstrate that the SureTemp® Plus thermometer meets the essential performance of clinical thermometers for body temperature measurement as described in ISO 80601-2-56:2009 **Applicable to Continuous Mode only. See Operation - Temperature on page 141.
Root NIBPT Parameter Chapter 15: Specifications Specification Max Voltage 36 VDC or 24 VAC peak Connectors Connector Type Number of Ports Ethernet 10/100 Mbps 1 Nurse Call 1/4 inch round female 1 MOC-9 Masimo Connector 3 USB USB 2.0 2 Iris RS-232/RJ-45 4 NIBP Nib Male Bayonet 1 Temperature MOLEX 52271-0690 1 Display Ranges NIBP www.masimo.
Root NIBPT Chapter 15: Specifications Patient Population Measurement Display Range Adult Pediatric Neonatal Systolic 40-260 mmHg Diastolic 20-200 mmHg MAP 26-220 mmHg Systolic 40-230 mmHg Diastolic 20-160 mmHg MAP 26-183 mmHg Systolic 40-130 mmHg Diastolic 20-100 mmHg MAP 26-110 mmHg Optional Integrated Temperature Measurement Display Range Temperature 80-110°F (26.7-43.3°C) Pulse Rate www.masimo.
Root NIBPT Measurement Chapter 15: Specifications Display Range Pulse Rate (PR) 30-220 bpm NIBP Pressurization Ranges Weight Greater than 75 lbs Patient Initial Maximum Category Pressurization Pressure Adult 160 mmHg 280 mmHg 140 mmHg 280 mmHg 90 mmHg 140 mmHg (34 kg) Between 15.4 - 75 lbs Pediatric (7 - 34 kg) Less than 15.4 lbs (7 Neonatal kg) Electrical Root AC Power requirements www.masimo.
Root NIBPT Chapter 15: Specifications Root Fuses (2) 2 Amp, Time Delay High Breaking Capacity (5x20mm), 250V Battery Type Lithium Ion 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 NIBPT Chapter 15: Specifications Root 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 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 www.masimo.com WLAN Radio: IEEE 802.
Root NIBPT Chapter 15: Specifications Communication (Wi-Fi) 2.4 GHz - 802.11b/g/n: 2412-2472 MHz Frequency 5.0 GHz - 802.11a/n: 5150-5250 MHz, 5250-5350 MHz, 5470-5725 MHz, 5725-5825 MHz Max Peak Output Power 18 dBm Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types OFDM, BPSK, CCK Modulation Signals Analog and Digital 802.11a - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. Available Data Rates 802.11b - 1, 2, 5.5, 11 Mbps. 802.
Root NIBPT Chapter 15: Specifications Communication (Bluetooth) Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Modulation Types DH5 Modulation Signals Analog and Digital Available Data Rates 1,2,3 Mbps Security and Authentication Encryption Authentication 64/128-bit WEP, Dynamic WEP, WPA-TKIP, WPA2-AES Open System, Shared Key, Pre-Shared Key (PSK), 802.
Root NIBPT Chapter 15: Specifications Radio Compliance Canada IC:7362A-MWM2 Model: RDS-7A or RDS-7 RSS-247 Europe EU Radio Equipment Directive (RED 2014/53/EU) EN 300 328:V2.1.1 EN 301 893:V2.1.1 EN 301 489-1:V2.2.0 EN 301 489-17 V3.1.1 EN 62311 Japan TELEC Article 2-1-19 Article 2-1-19-3 Article 2-1-19-3-2 Korea KN 301 489-1 V2.2.0 KN 301 489-17 V3.1.1 Compliance Electrical Safety ANSI/AAMI ES 60601-1:2005 www.masimo.
Root NIBPT Chapter 15: Specifications Electrical Safety CAN/CSA C22.2 No. 60601-1:2008 EN 60601-1:1990 + AI: 1993 + A2:1995 IEC 60601-1:2005 + A1: 2012 IEC 60601-1-8:2006 IEC 60601-2-49:2011 IEC 80601-2-30:2009 ISO 80601-2-56:2012 NIBP Module Standards AAMI SP10:2002 ISO 81060-2:2009 EN 1060-1:1996 +A2:2009 EN 1060-3:1997 +A2:2009 EN 1060-4:2004 www.masimo.
Root NIBPT Chapter 15: Specifications EMC Compliance EN 60601-1-2;2007, Class B Equipment Classification per IEC 60601-1 Type of Protection Class I (on AC power) Internally powered (on battery power) Degree of Protection of Electrical Defibrillation proof BF-Applied Part1 Shock Protection against harm from IPX1 Protection against liquid drops liquid ingress falling vertically.
Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Emissions Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment - Guidance ME Equipment uses RF energy only for its RF Emissions CISPR 11 internal function.
Root NIBPT www.masimo.
Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Immunity Guidance and Manufacturer's Declaration - Electromagnetic Immunity The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
Root NIBPT Chapter 15: 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, 100% for 0.5 Mains power quality short cycle should be that of a typical interruptions and voltage variations on power supply input lines. IEC 61000-4-11 Power frequency commercial or hospital 60% for 5 environment.
Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity to the frequency of the transmitter. Immunity Test IEC 60601 Compliance Recommended Test Level Level 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 3 V/m 80 MHz to 800 MHz: 2.5 GHz 800 MHz to 2.5 GHz: www.masimo.
Root NIBPT Chapter 15: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as --- --- --- determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.
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.
Root NIBPT Chapter 15: Specifications Rated maximum Separation Distance According to Frequency of output power of Transmitter (m) transmitter (W) 150 K Hz to 80 80 MHz to 800 800 MHz to MHz MHz 2.5GHz d = 1.17*Sqrt (P) d = 1.17*Sqrt (P) d = 2.33*Sqrt (P) 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.7 3.7 7.37 100 11.7 11.7 23.
Root NIBPT Chapter 15: Specifications Symbols The following symbols may appear on the product or product labeling: Symbol Description Symbol Description Follow instructions for Consult instructions for use use ETL Intertek Mark of conformity to certification European medical See Declarations on device directive Page 1 for 93/42/EEC certifications Fuse replacement- Protection against Only replace with vertically falling water time-delay fuses drops specified in this Instructions for U
Root NIBPT Symbol Chapter 15: Specifications Description Symbol Description Artery symbol and Cuff index line must arrow should be placed fall within range over brachial or markings for an femoral artery accurate measurement Index Line Non-Sterile Separate collection for Authorized electrical and representative in the electronic equipment European community (WEEE) Caution: Federal (USA) law restricts this device to sale by or on the Recyclable order of a physician Federal Non-ioniz
Root NIBPT Symbol Chapter 15: Specifications Description Symbol Description Industry Canada Electrostatic Identification No parameter alarms Biohazardous Waste Not for continuous Caution monitoring (No alarm for SpO2) Product contains no Catalog number PVC (polyvinyl (model number) chloride) material Not made with natural Manufacturer rubber latex Date of manufacture Masimo reference YYYY-MM-DD number Storage temperature Serial number range Fragile, handle with Keep dry care Stor
Root NIBPT Symbol Chapter 15: Specifications Description Symbol Description Atmospheric pressure Equipotential Ground limitation Terminal AC current Fuse Wireless features can be used in member states with the Wireless Symbol level restriction of indoor use in France -Class 2 wireless device Stand-By Iris Connection RS-232 Interface Ethernet Analog Out Interface Nurse Call Interface Greater than USB port China Restriction of Less than www.masimo.
Root NIBPT Symbol Chapter 15: Specifications Description Symbol Description The names and content of the toxic and hazardous --- substances or --- elements shall be provided in the product instruction manual Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available in all countries. www.masimo.
Chapter 16: Service and Maintenance This chapter contains information about cleaning, battery operation, performance verification, service, repair and warranty. Cleaning Root is a non-sterile and reusable device. The surface of the Root should be cleaned when the device is visibly dirty, before and after each procedure, and/or according to hospital practice. To surface clean, wipe down the outer surface of Root using any of the following: Cidex Plus (3.
Root NIBPT Chapter 16: Service and Maintenance To replace the fuse(s) 1. Power Off Root completely. Do not put in Sleep Mode. See Sleep and Power Off on page 138. 2. Remove the AC power cord from the Power Entry Module in the 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.
Root NIBPT Chapter 16: Service and Maintenance Power-On Self Test To conduct a Power-On Self Test 1. Connect Root to AC power, and verify that the AC Power Indicator 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. NIBP Module Calibration Test Note: This section is provided as a reference and intended for authorized service personnel only.
Root NIBPT Chapter 16: Service and Maintenance Connection Tubing *Verify the manometer has been calibrated within the last 12 months. Calibration accuracy shall be within ±0.02% to ±0.25% FS (Full Scale) and a measurement uncertainty of ±1 LSD (Least Significant Digit). www.masimo.
Root NIBPT Chapter 16: Service and Maintenance Procedure 1. Connect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb to the NIBP module using "T" adapters and connection tubing. 2. Power ON the manometer. Verify the manometer has been zeroed. Set the unit of measurement to mmHg. Verify the manometer has been calibrated. 3. Power ON the Root. 4. On the Root home screen, press the Main Menu icon www.masimo.com 233 .
Root NIBPT Chapter 16: Service and Maintenance 5. Press NIBP . 6. Press CALIBRATION . For the password, enter 4258. Press the Enter key. 7. Press CALIBRATION TEST . 8. Press Test. 9. Apply various pressures (0mmHg to 280mmHg) to the NIBP module with the hand bulb. 10.
Root NIBPT Chapter 16: Service and Maintenance Zero Point Calibration Zero Point Calibration is performed when an NIBP module does NOT PASS the NIBP Module Calibration Test. See the NIBP Module Calibration Test on page 231. Note: This section is provided as a reference and intended for authorized service personnel only. 1. Press the back button in the upper-left corner of the CALIBRATION TEST screen to go back to the CALIBRATION menu screen. 2. Select ZERO POINT CALIBRATION . 3.
Root NIBPT Chapter 16: Service and Maintenance Span Point Calibration Span Point Calibration is performed when an NIBP module does NOT PASS the NIBP Module Calibration Test, and after completing Zero Point Calibration. See the NIBP Module Calibration Test on page 231 and Zero Point Calibration on page 235 before completing the instructions below. Note: This section is provided as a reference and intended for authorized service personnel only. 1.
Root NIBPT 8. Chapter 16: Service and Maintenance Apply various pressures (0mmHg to 280mmHg) to the NIBP module with the hand bulb. 9. Compare the NIBP module pressure to the manometer pressure: If the NIBP module pressure and manometer pressure differ WITHIN the ±3mmHg tolerance, then the NIBP module has PASSED the calibration test and no further action is required. Go to step 10. Note: For pass criteria, see the NIBP Module Calibration Test on page 231.
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. Equipment Calibrated Manometer* Pneumatic "T" Adapters 500mL bottle Hand Bulb Connection Tubing *Verify the manometer has been calibrated within the last 12 months.
Root NIBPT Chapter 16: Service and Maintenance Procedure 1. Connect the manometer, 500mL bottle, and hand bulb to the NIBP module using "T" adapters and connection tubing. 2. Power ON the manometer. Set the unit of measurement to mmHg. Verify the manometer has been calibrated. 3. Power ON the Root. 4. On the Root home screen, press the Main Menu icon 5. Press NIBP 6. Press CALIBRATION www.masimo.com . . .
Root NIBPT Chapter 16: Service and Maintenance For the password, enter 4258. Press the Enter key. 7. Press AIR LEAK TEST . 8. To begin the air leak test, press Test. Wait for the countdown timer to reach 0 second. At the bottom of the screen, in the Result section, verify the leak rate is less than 6mmHg. If the leak rate is greater than 6mmHg, verify there are no leaks in the calibration equipment (tubing, 500mL container, arm cuff, etc.).
Root NIBPT Chapter 16: Service and Maintenance Adults, Pediatrics 300 ±10mmHg Neonates 150 ±5mmHg Equipment Calibrated Manometer* Pneumatic "T" Adapters 500mL bottle or regular-sized cuff wrapped around solid object Hand Bulb Connection Tubing *Verify the manometer has been calibrated within the last 12 months. Calibration accuracy shall be within ±0.02% to ±0.25% FS (Full Scale) and a measurement uncertainty of ±1 LSD (Least Significant Digit). www.masimo.
Root NIBPT Chapter 16: Service and Maintenance Test Method for Adults and Pediatrics 1. Connect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb to the NIBP module using "T" adapters and connection tubing. Note: If using a cuff, verify the cuff is Adult or Pediatric. Do not use a Neonate cuff for this test method. 2. Power ON the manometer. Set the unit of measurement to mmHg. Verify the manometer has been calibrated. 3. Power ON the Root. 4.
Root NIBPT Chapter 16: Service and Maintenance 5. Press NIBP . 6. Press CALIBRATION . For the password, enter 4258. Press the Enter key. 7. Press OVERPRESSURE TEST . 8. To begin the overpressure test, press the Test button, then increase the pressure to the overpressure point: Increase pressure to approximately 280mmHg using the hand bulb. Very slowly increase the pressure as you approach the overpressure point.
Root NIBPT Chapter 16: Service and Maintenance 11. Disconnect the manometer, 500mL bottle or cuff wrapped around solid object, and hand bulb from the NIBP module. 12. Power OFF the manometer. Test Method for Neonates 1. Follow steps 1 through 3 from Test Method for Adults and Pediatrics above. Note: If using a cuff, verify the cuff is Neonate. Do not use an Adult or Pediatric cuff for this test method. 2. On the Root Main Screen, touch the Profiles option in the Status Bar.
Root NIBPT Chapter 16: Service and Maintenance Increase pressure to approximately 130mmHg using the hand bulb. Very slowly increase the pressure as you approach the overpressure point. When the overpressure point is reached, the valves will open (a faint click can be heard when this occurs) and the pressure will rapidly reduce to 0mmHg. Be sure to observe the pressure measurement on the manometer when the valves open. 10.
Root NIBPT Chapter 16: Service and Maintenance disconnected. In addition, the Nurse Call Polarity can be inverted to accommodate various nurse call station requirements. See Device Output on page 116. Only authorized service personnel should connect one of these two signals to a hospital’s Nurse Call system.
Root NIBPT Chapter 16: Service and Maintenance 3. When Root is fully charged, the Root Charging Indicator turns off. 4. Power On Root and verify that the Root Battery Indicator icon on the Status Bar shows a full charge. Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the device repaired.
Root NIBPT Chapter 16: Service and Maintenance Ship-to and bill-to information. Person (name, telephone/Telex/fax number, and country) to contact for any questions about the repairs. A certificate stating the Root has been decontaminated for bloodborne pathogens. Return the Root to the shipping address listed in Contacting Masimo. Masimo Technical Services To contact Masimo Technical Services, refer to the Masimo Technical Services web page: http://www.masimo.co.
Root NIBPT Chapter 16: Service and Maintenance Masimo’s user manuals, technical specifications, and other Masimo published guidelines for a period of 12 months and any batteries for six (6) months from the original date the Product was obtained by the end-user 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.
Root NIBPT Chapter 16: Service and Maintenance No warranty applies to any Product provided to Purchaser for which Masimo, or its authorized distributor, is not paid; and these Products are provided AS-IS without warranty. Limitation of Warranty Except as otherwise required by law or altered by the purchase agreement, the above warranty is the exclusive warranty that applies to the Product and software media, and Masimo does not make any other promises, conditions, or warranties regarding the Product.
Root NIBPT Chapter 16: Service and Maintenance Product, the following terms are the entire agreement between the parties regarding your purchase of this Product. If you do not agree to the terms of this agreement, promptly return the entire Product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund. Restrictions 1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted.
Root NIBPT Chapter 16: Service and Maintenance without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void. 4. U.S.
Appendix: Concepts of Alarm Response Delay Concepts of Alarm Response Delay As with any patient monitors, the audible and visual alarms are subject to alarm response delay, which is composed of Alarm Condition Delay and Alarm Signal Generation Delay. Alarm Condition Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists.
Root NIBPT Appendix: Concepts of Alarm Response Delay Reference Definition 2 Alarm Limit 3 Displayed SpO2 4 Alarm Signal Generation SpO2 t Saturation Time The Alarm Condition Delay is graphically represented as t2 – t1 in the figure above to show the delay due to processing and averaging. The Alarm Signal Generation Delay is graphically represented as t3 – t2 in the figure above to show the delay due to alarm system strategy and communication time.
Index Alarms • 134 A Appendix Alarms for Temperature • 54, 55 Concepts of Alarm Response Delay About • 49, 74 • 163 About the Action Bar • 36, 82 Attach NIBP Cuff • 31 About the Main Screen • 33, 67 Attach the Probe Well • 30 About the Status Bar • 27, 28, 34, Attach the Temperature Probe • 65, 66, 67, 68, 69, 80, 119, 120, 31 158 Audio Pause • 34, 63, 73, 80 About This Manual • 7 Available Layouts • 50, 51 AC Power Indicator • 27, 86 Access Control • 63, 64, 70 B Accessing Main Menu O
Root NIBPT Index Admit and Discharge to Patient Chapter 10 SafetyNet • 36, 103 MOC-9 • 30, 115 Chapter 7 Chapter 11 Electronic Medical Record (EMR) Iris • 35, 50, 117 Push • 36, 109 Chapter 12 Chapter 8 Bluetooth Devices • 31, 123 Radical-7 • 111 Chapter 13 Chapter 9 Messages • 125 Radius-7 • 113 Chapter 14 Cleaning • 149, 160 Troubleshooting • 129 Cleaning and Service Warnings Chapter 15 and Cautions • 18 Specifications • 133 Compliance • 139 Chapter 16 Compliance Warnings and
Root NIBPT Index Cuff Selection and Placement • Front View • 21 93, 95, 97, 99, 101 G Customizing Windows • 37, 46, 53, 54 Guidance and Manufacturer's Declaration-Electromagnetic D Emissions • 141 Determining EMR Push is Active • Guidance and Manufacturer's 109 Declaration-Electromagnetic Immunity • 142 Device Output • 30, 34, 65, 72, 159 Guidelines for Setting Up • 25 Device Settings • 49, 64 I Discharging a Patient • 105 Display Ranges • 135 Indications for Use • 9 Downloading Screen C
Root NIBPT Index L N Layout • 49, 50 NIBP • 49, 58 Lights • 86 NIBP Air Leak Test • 154 Limitation of Warranty • 161 NIBP Module Calibration Test • 63, 150, 152, 153 Limited Warranty • 161 NIBP Pressurization Ranges • 136 Localization • 35, 64, 65 Noninvasive Blood Pressure • 14, M 17 Manual Sizing of Windows • 48 Not Admitted • 103 Manually Entering Patient Data • Not Monitoring Message • 106 Nurse Call Connection • 30 109, 110 Nurse Call Setting Connections • Masimo Kite • 31 130, 1
Root NIBPT Index Radical-7 Connection • 28 P Radius-7 Connection • 29 Parameter Settings for NIBP • 58 Rainbow • 49, 54 Parameters Supported • 74 Recommended Separation Patient Conditions • 94 Distances • 144 Patient Measurement Mode • 93 Repair Policy • 149, 160 Patient SafetyNet System • 18 Replacing the Fuses • 129, 149 Performance Warnings and Restrictions • 162 Cautions • 15 Return Procedure • 25, 129, 130, Power On • 26 160 Power-On Self Test • 150 Root Battery • 27, 64, 68 Prod
Root NIBPT Index Set Mode Trends for NIBP • 60 Automatic • 61, 97 Trends for Temperature • 54, 56 Schedule • 62, 101 Troubleshooting Radical-7, Stat • 62, 99 Radius-7, and MOC-9 Side Views • 24, 86 Modules • 129 Troubleshooting Root • 129 Sleep and Power Off • 26, 88, 149 Sounds • 35, 49, 63, 70, 80 U Span Point Calibration • 152, 153 Spot Check Measurement • 95 Understanding Windows • 41 Standby Mode • 34, 71, 80 Unpacking and Inspection • 25 Symbols • 145 Using Analog View • 42, 44 Sys
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