Masimo Radical-7 Operator's Manual
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Masimo Radical-7 Operator's Manual

Pulse co-oximeter
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Summary of Contents for Masimo Radical-7

  • Page 1 Operator's Manual ® ® Radical-7 Pulse CO-Oximeter...
  • Page 3 These operating instructions provide the necessary information for proper operation of all models of the Radical-7. 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 Radical-7 are prerequisites for its proper use.

  • Page 5: Table Of Contents

    Root------------------------------------------------------------------------------------------------------ 38 Monitor Interface With SatShare ------------------------------------------------------------------- 39 Chapter 3: Setup ------------------------------------------------------------------------------------------- 41 Unpacking and Inspection --------------------------------------------------------------------------- 41 Powering Radical-7 On, Standby, and Power Off -------------------------------------------------- 41 Initial Battery Charging ------------------------------------------------------------------------------- 42 Docking Station Setup -------------------------------------------------------------------------------- 42 Root Setup ---------------------------------------------------------------------------------------------- 43...
  • Page 6 About Alarms ----------------------------------------------------------------------------------------- 101 3D Alarms --------------------------------------------------------------------------------------------- 103 Radical-7 Messages ---------------------------------------------------------------------------------- 105 Chapter 7: Troubleshooting ----------------------------------------------------------------------------- 111 Troubleshooting Measurements-------------------------------------------------------------------- 111 Troubleshooting the Radical-7 --------------------------------------------------------------------- 114 Chapter 8: Specifications ------------------------------------------------------------------------------- 119 Display Range ----------------------------------------------------------------------------------------- 119 Accuracy (ARMS*) ------------------------------------------------------------------------------------ 119 Resolution ---------------------------------------------------------------------------------------------- 121...
  • Page 7 Replacing the Fuses --------------------------------------------------------------------------------- 143 Performance Verification --------------------------------------------------------------------------- 143 Repair Policy ------------------------------------------------------------------------------------------ 146 Return Procedure ------------------------------------------------------------------------------------- 146 Contacting Masimo ---------------------------------------------------------------------------------- 146 Appendix: Concepts of Alarm Response Delay ------------------------------------------------------ 149 Concepts of Alarm Response Delay --------------------------------------------------------------- 149 Index ------------------------------------------------------------------------------------------------------- 151 www.masimo.com...

  • Page 9: About This Manual

    This manual explains how to set up and use Radical-7® Pulse CO-Oximeter®. Important safety information relating to general use of Radical-7 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.

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

    (SpCO®), total oxygen content (SpOC), methemoglobin (SpMet), Pleth Variability Index (PVi®), and Acoustic Respiration Rate (RRa®). The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7 features a touchscreen that continuously displays numeric values for all parameters.

  • Page 12: Indications For Use

    ), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7® Pulse CO-Oximeter® and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

  • Page 13: Safety Information, Warnings And Cautions

    Safety Warnings and Cautions WARNING: Do not use the Radical-7 if it appears or is suspected to be damaged. Damage to the device can result in exposed electrical circuits that may cause patient harm.

  • Page 14: Performance Warnings And Cautions

    CAUTION: To ensure patient electrical isolation, only dock to Masimo devices that have been designed for Radical-7. CAUTION: Do not place Radical-7 where the appliance inlet or the AC power plug cannot be readily disconnected. CAUTION: Use a grounded outlet for proper equipment grounding. A hospital-grade outlet is required.
  • Page 15 Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional data. WARNING: Do not use Radical-7 as an apnea monitor. Radical-7 does not have alarms to alert you when you are not breathing properly.
  • Page 16 Radical-7 Safety Information, Warnings and Cautions • Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position). • Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g. cardiac arrhythmias, intra-aortic balloon, etc.). • Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
  • Page 17 Radical-7 Safety Information, Warnings and Cautions • Excessive venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position). • Elevated PaO levels. • Elevated levels of bilirubin. • Low arterial perfusion. • Motion artifact. • Low arterial oxygen saturation levels. • Elevated COHb and/or MetHb levels.
  • Page 18 Failure to take this precaution in high ambient light conditions may result in inaccurate measurements. CAUTION: For home use, ensure that the Radical-7 alarm can be heard from other rooms in the house, especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or radios are operating.
  • Page 19 Sensor DFU for the specified duration of patient monitoring time. Note: If the Radical-7 stops communicating with Root, parameters and measurements will not show on the Root display; however, this will not affect Radical-7's ability to monitor the patient. Note: It is recommended that Radical-7 battery is fully charged prior to use.

  • Page 20: Cleaning And Service Warnings And Cautions

    Note: When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be compromised. If the Radical-7 is in this setting and the sensor becomes dislodged from the patient, the potential for false readings may occur due to environmental "noise"...

  • Page 21: Compliance Warnings And Cautions

    CAUTION: To avoid permanent damage to the Radical-7, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended.
  • Page 22 5.25-5.35 GHz and 5.65-5.85 GHz and that these radars could cause interference and/or damage to LE-LAN devices. Note: In accordance with FCC requirements, radio accessories on Radical-7 cannot be attached directly to the patient using any accessory containing metal components.

  • Page 23: Chapter 1: Technology Overview

    Masimo products. Signal Extraction Technology® (SET®) Masimo Signal Extraction Technology's signal processing differs from that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the venous...
  • Page 24 SpO and pulse rate. Functional Oxygen Saturation (SpO2) The Radical-7 is calibrated to measure and display functional oxygen saturation (SpO ): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen.
  • Page 25 Radical-7 Chapter 1: Technology Overview General Description for Pulse Rate (PR) Pulse rate (PR), measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse. General Description for Perfusion Index (Pi) The Perfusion Index (Pi) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue.

  • Page 26: Rainbow Pulse Co-Oximetry Technology

    Radical-7 Chapter 1: Technology Overview Loupec T., Nanadoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene B., Dahyot-Fizelier C., Mimoz O. Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients. Crit Care Med. 2011 Feb;39(2):294-9. Fu Q., Mi W.D., Zhang H. Stroke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness during Resection of Primary Retroperitoneal Tumors in Hans Chinese.
  • Page 27 The Radical-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle.
  • Page 28 The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO , SpCO, SpMet, SpHb, and SpOC measurements of the Radical-7. Any comparisons should be simultaneous, meaning the measurement on the device should be noted at the exact time that blood is drawn.
  • Page 29 Radical-7 Chapter 1: Technology Overview measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. See Safety Information, Warnings and Cautions on page 11 and Troubleshooting Measurements on page 111.

  • Page 30: Rainbow Acoustic Monitoring™ (Ram™)

    Cautions on page 11. SpCO, SpMet, and SpHb Measurements During Patient Motion The Radical-7 displays measurements of SpCO, SpMet, and SpHb during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion.
  • Page 31 Radical-7 Chapter 1: Technology Overview Respiratory sounds include sounds related to respiration such as breath sounds (during inspiration and expiration), adventitious sounds, cough sounds, snoring sounds, sneezing sounds, and sounds from the respiratory muscles [1]. These respiratory sounds often have different characteristics depending on the location of recording [2] and they originate in the large airways where air velocity and air turbulence induce vibration in the airway wall.
  • Page 32 Radical-7 Chapter 1: Technology Overview Acquisition System The acquisition system converts the electric signal provided by the sensor into a digital signal. This format allows the signal to be processed by a computing device. Signal Processing The digital signal produced by the acquisition system is converted into a measurement that corresponds to the respiratory parameter of interest.

  • Page 33: Chapter 2: Description

    Chapter 2: Description The following chapter contains the Radical-7 descriptions, including descriptions of the Handheld monitor, the Standalone monitor (Docking Station), and the optional SatShare monitor interface. General System Description The Radical-7 system includes the following: Device Patient Cable Sensor For a complete list of compatible sensors and cables, visit http://www.masimo.com.
  • Page 34 For complete information, see the Operator's Manual for Root. Monitor Interface Utilizing a SatShare cable, the standalone Radical-7 also interfaces with the SpO input of a validated multi-parameter patient monitor, instantly upgrading the conventional pulse oximetry to Masimo SET® pulse oximetry.

  • Page 35: Handheld

    5. Alarm Silence Button Temporarily silences alarms. See Silencing the Alarms on page 102. 6. Power button Turns Radical-7 on or off or places in standby mode. 7. Speaker Provides audio alarms and feedback. 8. Patient Cable Connector Provides a connection to a patient cable or sensor.
  • Page 36 Radical-7 Chapter 2: Description Handheld Back View The Handheld back panel features the connection to the Docking Station, an accessory mount for the pole clamp accessory, and access to the Handheld battery pack. 1. Connector The Handheld interfaces with the Docking Station through this connector.

  • Page 37: Docking Station

    Radical-7 Chapter 2: Description Docking Station When the Handheld is placed into a Docking Station, the two components become a full-featured Standalone system. In this manual, when the Handheld and an RDS Docking Station are connected, they are referred to as Standalone. The Standalone acts as a battery charger for the Handheld and has AC power connection capabilities.
  • Page 38 Radical-7 Chapter 2: Description To determine the RDS Docking Station being used with Radical-7, RDS-1 and RDS-1a have a SatShare Interface connector on the rear, RDS-2 and RDS-3 does not. See Docking Station Back Panel on page 37. Docking Station Front View 1.
  • Page 39 1. Serial Output connector - Provides connection with a serial device, including a serial printer, a monitoring system, or PC to the Radical-7. The data is provided in standard RS-232C format. All external device connections to the Serial Output connector must be IEC-60950 compliant.

  • Page 40: Root

    Chapter 2: Description Root When the Radical-7 Handheld is placed (docked) into Root and Root is powered on, Root displays the Radical-7 parameters. Root acts as a battery charger for the Handheld. For complete information about using Radical-7 with Root, refer to the Operator's Manual for Root.

  • Page 41: Monitor Interface With Satshare

    Radical-7 Chapter 2: Description Monitor Interface With SatShare The Radical-7 has a unique SatShare interface that links to most existing validated multi-parameter patient monitors through a SatShare cable that connects to the rear of the Docking Station. • Upgrades any approved and validated monitor to Masimo SET® performance by...

  • Page 43: Chapter 3: Setup

    If anything is missing or damaged, contact the Technical Service Department. See Return Procedure on page 146. Powering Radical-7 On, Standby, and Power Off Use the Power Button to Power On, put the Radical-7 in Standby Mode, or completely Power Off. State Description Power On Press and release the Power Button.

  • Page 44: Initial Battery Charging

    Snap the Radical-7 into the Docking Station. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to power it on. When properly connected, the Radical-7 Charging Indicator light will illuminate on the Docking Station.

  • Page 45: Root Setup

    Turn on Root. Snap the Radical-7 into Root. If the Radical-7 is not yet turned on, press the power button on the Radical-7 to power it on. When properly connected, the Root display will show active measurements and parameters from Radical-7.

  • Page 46: Philips, Agilent, Or Hp Vuelink Setup

    Philips, Agilent, or HP VueLink Setup To set up for use with VueLink compatible monitors (Philips, Agilent, or HP): On the Radical-7, on the Device Output screen, for the Serial option, select HP VueLink. Connect one end of the VueLink cable to the Serial Output connector on the Docking Station.
  • Page 47 Radical-7 Chapter 3: Setup On the Radical-7, on the Device Output screen, for the Serial option, select SpaceLabs Flexport. Connect one end of the Spacelabs Flexport cable to the Serial Output connector on the Docking Station. Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal Flexport connector.

  • Page 49: Chapter 4: Operation

    Chapter 4: Operation The following chapter contains information about using the Radical-7. The Radical-7 Handheld, Docking Station, and Standalone should not be operated outside the environmental conditions listed in the specifications section Environmental on page 122. Using the Touchscreen and Buttons 1.
  • Page 50 55. and drop it by releasing. Below is a list of all the different types of controls available on Radical-7 and the various ways to interact with each type of control. Control Applicable Actions Description •...
  • Page 51 Radical-7 Chapter 4: Operation Control Applicable Actions Description • Quickly moves knob left or right Press left or right of toggle • Switches between toggle states Labeled Toggle Slide knob • Quickly moves knob left or right Press left or right of toggle •...
  • Page 52 Radical-7 Chapter 4: Operation Control Applicable Actions Description • Scrolls icons left or right Swipe left or right (anywhere) • Quickly centers tile corresponding to indicator Press bottom icon indicator icon • When no parameter or measurement alarm is Window...

  • Page 53: About The Main Screen

    Radical-7 Chapter 4: Operation Control Applicable Actions Description • Silences all alarms Alarm Silence Press icon • Enables Audio Pause Audio Pause Press icon • Opens relevant menu Other Status Press Bar icons • Exits menu, abandons any changes Back Arrow...
  • Page 54 Provides access to the Bluetooth screen. If this icon is visible, then Bluetooth connectivity has been enabled. Bluetooth See Bluetooth on page 87. Displays charging status for Radical-7. Provides access to the Battery screen. The example shows that AC power is connected Radical-7 Battery and the battery is currently charging.
  • Page 55 See Localization on page 85. AC Power Indicator Whenever Radical-7 is ON and docked to Root or a Docking Station that is connected to AC power: • Docked to Docking Station - The AC Power Indicator icon will appear on the Radical-7 display.
  • Page 56 See Radical-7 Battery on page 87. Sensitivity Modes Overview Three sensitivity levels enable a clinician to tailor the response of the Radical-7 to the needs of the particular patient situation. Access the menu by touching on the indicator in the upper left corner of the Main Screen.
  • Page 57 Radical-7 Chapter 4: Operation From the Profiles screen, select the desired mode by scrolling up or down. Then select OK. Note: The device will revert to APOD mode after a power cycle. See Changing Profiles on page Using Screen Lock When enabled, the Screen Lock feature may prevent unintentional interaction with the touchscreen.
  • Page 58 Radical-7 Chapter 4: Operation Waveform Views The following section contain information about the waveforms available in the Trend Field on the Main Screen. Select Waveform The Trend Field allows users to access various waveform views. To access waveform views on the Display View screen Press/select the Trend Field, as shown below.
  • Page 59 Radical-7 Chapter 4: Operation The Trend Field displays the specific waveform option that was selected. Signal IQ Indicators Signal IQ (SIQ) indicators are displayed as vertical bars for each individual pulsation. The height of the bar provides an assessment of the confidence in the SpO measurement displayed.
  • Page 60 Radical-7 Chapter 4: Operation Customizing Windows To change the size of parameter values on the Main Screen: Press/select and hold any one of the parameters in the Well (Pi in this example). The well contains any parameters not displayed in the larger area above.
  • Page 61 Radical-7 Chapter 4: Operation About Trend Views There are different ways to view trend information. The following is an example of trend information for SpO as it appears within the Display View screen. The following is an example of trend information for SpO as it appears in the Full Trend screen.
  • Page 62 Radical-7 Chapter 4: Operation Scroll up or down to select a time interval. Changing Between Trend Views To toggle between Display View and Full Trend From the Display View, in the Trend Field, touch the icon as shown below. From the Full Trend screen, touch the icon as shown below.
  • Page 63 Radical-7 Chapter 4: Operation Manipulating View of Trend Data On the Full Trend screen, with a pinch gesture, using two fingers, the user can zoom in and out of the trend time scale. The user can add parameters to the Trend view by dragging and dropping parameters from the Small Parameter view.
  • Page 64 Radical-7 Chapter 4: Operation Using the Histogram Feature Users can view trend data using the Histogram feature. When turned on, the Histogram feature displays trend data as a histogram. To turn on the Histogram feature Navigate to a Full Trend screen. See Changing Between Trend Views on page 60.
  • Page 65 When the Radical-7 is docked to Root, the Radical-7 provides a supplemental visualization of the alarm status for the connected Masimo medical technologies. Note: The visualization may not be visible on Radical-7 depending on the layout settings in Root. Refer to the Operator's Manual for Root for layout setting information.
  • Page 66 Radical-7 Chapter 4: Operation Parameter Visualization Table Monitoring and alarm status for various parameters and/or measurements are visualized using the following areas/organs on the screen: Parameter or Measurement Area Displayed on Visualization Screen Lung Heart Vascular SpHb Vascular SpMet Vascular...

  • Page 67: Accessing Main Menu Options

    Radical-7 Chapter 4: Operation Accessing Main Menu Options To access Main Menu options, press the Main Menu icon in the bottom Right corner of the touchscreen: The Main Menu options are: Parameter Settings See Parameter Settings on page 67. Profiles See Chapter 5: Profiles on page 97.
  • Page 68 Radical-7 Chapter 4: Operation Navigating the Main Menu Once the Main Menu screen is displayed, users can access additional screens, information and settings. Swipe the screen left or right to pan through the Menu Icons. Touch the arrow icon to return to the Main Screen.

  • Page 69: Parameter Settings

    Radical-7 Chapter 4: Operation About Parameter Information Additional information about each parameter is available. To access additional information about parameters: From the Parameter Settings screen, touch the About icon. The following is an example for SpO An About screen appears for the selected parameter and displays information about the parameter.
  • Page 70 Radical-7 Chapter 4: Operation • See RRa Settings on page 75. • See SpHb Settings on page 77. • See SpOC Settings on page 79. • See SpMet Settings on page 80. • See SpCO Settings on page 81. Histogram Settings Users can change the ranges of bins in the histogram view for each individual parameter displayed.
  • Page 71 Radical-7 Chapter 4: Operation Touch and drag the markers to adjust the range values. Note: If one of the Bin settings is changed, all other Bin settings are effected. For example, if Bin 2 is changed to a span of 4 to 32, Bin 1 changes to a span of 0 to 3, and Bin 3 changes to a span of 33 to 60.
  • Page 72 When Radical-7 is set to FastSat On, the averaging algorithm evaluates all saturation values, providing an averaged saturation value that is a better representation of the patient’s current oxygenation status.
  • Page 73 Radical-7 Chapter 4: Operation SpO2 Histogram From the Histogram screen, change any of the following options: Options Description Factory Default User Configurable Settings Settings* Bin 1 0-80 0 to 96 in steps of 1 Bin 2 81-85 1 to 97 in steps of 1...
  • Page 74 Radical-7 Chapter 4: Operation PR Histogram From the Histogram screen, change any of the following options: Options Description Factory Default User Configurable Settings Settings* Bin 1 0-50 0 to 246 in steps of 1 Bin 2 51-100 1 to 247 in steps of 1...
  • Page 75 Radical-7 Chapter 4: Operation Options Description Alarm Factory Default User Configurable Settings Priority Settings Off, or 0.03 to 0.09 in steps of 0.01 Low Limit is the lower threshold that Medium Limit 0.10 to 0.90 in steps of 0.10 triggers an alarm.
  • Page 76 Radical-7 Chapter 4: Operation PVi Settings From the PVI Settings screen, access any of the following options: PVi Alarms on page 74. Additional Settings for PVi on page 74. About Parameter Information on page 67. Trends on page 93. PVi Histogram on page 75.
  • Page 77 4 to 100 in steps of 1 * See Histogram Settings on page 68 for additional information. RRa Settings RRa is active under the following conditions: • RRa is installed on the Radical-7. • Dual rainbow cable is connected. • Acoustic sensor is connected.
  • Page 78 Radical-7 Chapter 4: Operation RRa Alarms From the RRa Alarms screen, change any of the following options: Options Description Alarm Factory User Configurable Priority Default Settings Settings 6 to 119 breaths per High Limit is the upper 30 breaths minute in steps of 1...
  • Page 79 Radical-7 Chapter 4: Operation RR Histogram From the Histogram screen, change any of the following options: Options Description Factory Default User Configurable Settings* Settings Bin 1 0-14 0 to 116 in steps of 1 Bin 2 15-28 1 to 117 in steps of 1...
  • Page 80 Radical-7 Chapter 4: Operation SpHb Alarms From the SpHb Alarms screen, change any of the following options: Options Description Alarm Factory Default User Configurable Settings Priority Settings 2.0 to 24.5 g/dL in steps of 0.1 g/dL, or 2.0 to 15.0 mmol/L in steps of 0.1 High Limit 17.0 g/dL...
  • Page 81 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Allows the user to set the precision of the Precision displayed SpHb value. 0.1, 0.5, or 1.0 (units of g/dL and Note: When unit is g/L, Precision is...
  • Page 82 Radical-7 Chapter 4: Operation SpOC Alarms From the SpOC Alarms screen, access the following screens: Options Description Alarm Factory User Configurable Priority Default Settings Settings High Limit is the upper High 2 to 34 ml/dl in steps threshold that triggers an...
  • Page 83 Radical-7 Chapter 4: Operation SpMet Alarms From the SpMet Alarms screen, change any of the following options: Options Description Alarm Factory Default User Configurable Settings Priority Settings 1.0 to 2.0% in steps of 0.1% High Limit is the High upper threshold that High 3.0%...
  • Page 84 Radical-7 Chapter 4: Operation SpCO Alarms From the SpCO Alarms screen, change any of the following options: Options Description Alarm Factory User Configurable Priority Default Settings Settings 2 to 98%, in steps of High Limit is the upper 1%, or Off...

  • Page 85: Sounds

    Use the Sounds screen to control the volume of sounds and duration of audio pause on Radical-7. Users can also access the Sounds screen by pressing the Sounds icon on the Status Bar. See About the Status Bar on page 52.

  • Page 86: Device Settings

    Radical-7 Chapter 4: Operation Device Settings The Device Settings menu allows the user to view and customize settings for Radical-7. The Device Settings options are: Screen Orientation See Screen Orientation on page 85. Localization See Localization on page 85. Wi-Fi See Wi-Fi on page 86.
  • Page 87 Description Factory Default Configurable Settings Setting Current Date Displays the current date set on the device Current Displays the current time set Time on the device Selects the language display Choose from available Language English for Radical-7. languages. www.masimo.com Masimo...
  • Page 88 Wi-Fi communication in order to ensure alarms are received. Use the Wi-Fi screen to enable or disable Wi-Fi connectivity. When Radical-7 is connected to a Wi-Fi network, the Wi-Fi icon on the Status Bar indicates the strength of the connection. The user can also access the Wi-Fi screen by pressing the Wi-Fi icon on the Status Bar.
  • Page 89 Radical-7 Battery Use the Battery screen to view the specific percentage of charge remaining in Radical-7's battery. The user can also access the Battery screen by pressing the Battery icon on the Status Bar. See About the Status Bar on page 52.
  • Page 90 Description State of Charge Provides a read-only display of battery level remaining. Battery Diagnostics Allows trained personnel to access battery diagnostic information. Brightness Use the Brightness screen to adjust the brightness of Radical-7's display. Option Description Factory User Configurable Default...
  • Page 91 Radical-7 Chapter 4: Operation Using the Password screen On the Password screen, enter the following numbers: 6 2 7 4 No numbers will be displayed, only asterisks (****). To undo numbers, press/select Backspace. To confirm, press/select Enter. From the Access Control screen, change any of the following options:...
  • Page 92 Legacy Changes the display from color to Color Mono or Color Mode monochrome. Data Facilitates data collection for Masimo Collection On or Off personnel use only. Enabled The nurse call output will be activated based on the alarm events. Nurse Call...
  • Page 93 * Displays only when docked in a docking station in stand alone configuration. ** Disabled if currently monitoring or a cable is connected to the device. Disconnect sensor and/or cable from Radical-7 to perform reset. Device Output The Device Output screen allows the user to configure additional data output options.

  • Page 94: About

    **** Cannot be enabled on RDS-3. About For information about parameters, see About Parameter Information on page 67. Use the About screen to view the serial number as well as Radical-7 software and hardware version information. These details may be helpful during troubleshooting. www.masimo.com...

  • Page 95: Trends

    The maximum and minimum possible values differ depending on the selected parameter. See Customizing Trend Views on page 58 for additional information. Trend Settings Use the Trend Settings screen to configure Trend Views on the Main Screen and trend data storage on Radical-7. Option Description Factory Default...
  • Page 96 Radical-7 Chapter 4: Operation Option Description Factory Default User Configurable Settings Setting Y-axis Max 5 to 100 in steps of 5 Y-axis Min 0 to 95 in steps of 5 Y-axis Max 30 to 240 in steps of 5 Y-axis Min...
  • Page 97 Radical-7 Chapter 4: Operation Option Description Factory Default User Configurable Settings Setting Y-axis Max 1 to 100 in increments of 1 SpCO Y-axis Min 0 to 99 in increments of 1 www.masimo.com Masimo...

  • Page 99: Chapter 5: Profiles

    The active profile displays in the Status Bar. In the following example, the Adult profile is active. The Radical-7 conveys the active profile by changing the color of the Profiles button. In the following example, the Adult profile is active (Blue).
  • Page 100 Radical-7 Chapter 5: Profiles • Touch the Profiles shortcut in the Status Bar, as show below. • Press the Profile button, as shown below. • Alternatively, from the Main Menu screen, touch the Profiles icon. Change Patient Type From the Profile screen, touch the Patient Type field.

  • Page 101: Profiles Settings

    When finished, touch OK. To confirm selection, check the Status Bar. Profiles Settings The Radical-7 can be configured for various patient types through the Profiles option located under the main menu options. See Accessing Main Menu Options on page 65.

  • Page 102: Replacing Factory Default Settings For Adult And Neo Profiles

    Neonatal are saved in place of the factory default settings, the Profile button changes to the same blue, green or pink color respectively. See Profiles Overview on page 97. A user can also load preferred profile configurations into the Radical-7 using a separate tool. Change Default Profile Settings: Change the Radical-7 Adult, Pediatric or Neonatal profile settings to the desired configuration.

  • Page 103: Chapter 6: Alarms And Messages

    Alarms can have different priority levels and come from different sources. The following tables describe alarm behaviors on Radical-7 in more detail. Note: When Radical-7 is docked to Root, the alarms may be displayed and interacted with directly through the Root display. Refer to the Operator's Manual for Root for complete information.
  • Page 104 Radical-7 Chapter 6: Alarms and Messages Alarm Source/Example Explanation Parameter Level This example is a SpO alarm (SpO Low) as the reading exceeds the lower alarm limit. Note: The SpO parameter is illuminated red, and the Silence option is shown at the top of the screen.

  • Page 105: 3D Alarms

    Radical-7 Chapter 6: Alarms and Messages To silence audible alarms: When an audible alarm is active, push Alarm Silence one time. The audible alarm is silenced for up to 120 seconds and a countdown timer displays. The length of time for which an audible alarm remains silenced (suspended) can be changed using the Silence Duration feature located on the Sounds screen.
  • Page 106 (delta) over a specific period of time. Perfusion Index gives an indication of the level of perfusion at the monitored site. Radical-7 measures perfusion at the monitored SpO site by comparing the pulsatile signal to the non-pulsatile signal, and expressing that ratio as a percentage.

  • Page 107: Radical-7 Messages

    Pi Delta audibly and visually alerts the user to important changes in a patient's perfusion, as compared to the patient’s baseline Pi rate. The baseline is set by Radical-7 once the user has enabled the alarm and represents 30 seconds of currently averaged Pi. To set a Pi Delta alarm, see Pi Delta on page 105.
  • Page 108 Radical-7 Chapter 6: Alarms and Messages Message Potential Causes Next Steps • • Patient cable has less than Replace with new patient (Pulse CO-Ox) 10% of active monitoring life cable. Cable Near remaining. Expiration (RAM) Cable Near Expiration • •...
  • Page 109 Radical-7 Chapter 6: Alarms and Messages Message Potential Causes Next Steps • • Not a proper Masimo sensor. Replace with a proper (Pulse CO-Ox) Masimo sensor. Incompatible • Sensor is attached to a device Sensor • without an appropriate Use a compatible sensor.
  • Page 110 If pulse search continues, move sensor to better perfused site. • • High intensity light (pulsating Place a Masimo Optical (Pulse CO-Ox) strobe lights, excessive Light Shield over the Interference ambient light sources such as sensor. Detected surgical lights or direct •...
  • Page 111 Occurs during an unsuccessful See the directions for use (Pulse CO-Ox) SpO sensor initialization/pulse provided with your sensor. Only Mode search routine or during Use a Masimo light shield monitoring. to cover the sensor and adjust the sensor. • • Indicates low signal...

  • Page 113: Chapter 7: Troubleshooting

    Chapter 7: Troubleshooting The following chapter contains information about troubleshooting the Radical-7 system. Troubleshooting Measurements The following section lists possible measurement symptoms, the potential cause, and next steps. For additional information, see Safety Information, Warnings and Cautions on page 11.
  • Page 114 Radical-7 Chapter 7: Troubleshooting Symptom Potential Causes Next Steps • • Inappropriate sensor or Allow time for parameter reading to Difficulty sensor size. stabilize. obtaining a reading. • • Improper sensor type or Verify sensor type and size and application.
  • Page 115 Radical-7 Chapter 7: Troubleshooting Symptom Potential Causes Next Steps • • Low Signal Quality Assess the patient. Dimly Lit Parameters • Verify sensor type and size and re-apply sensor. See Directions for Use for Sensor. • Check if blood flow to the sensor site is restricted.

  • Page 116: Troubleshooting The Radical-7

    Radical-7 Chapter 7: Troubleshooting Troubleshooting the Radical-7 The following section lists possible Radical-7 symptoms, potential causes, and next steps. For more information, see Chapter 6: Alarms and Messages on page 101. Symptom Potential Causes Next Steps • • Depleted Battery.
  • Page 117 Radical-7 Chapter 7: Troubleshooting Symptom Potential Causes Next Steps • • The device is Off. Turn Radical-7 Off and On. Device screen is blank • • The brightness Adjust the brightness setting. See Brightness on display is not correct. page 88.
  • Page 118 Sensor expired. patient. Refer to sensor Directions For Use. • Internal failure. • Replace sensor. • Turn Radical-7 Off and On. • Contact Masimo service. See Contacting Masimo on page 146. • • External device is not Check external device Device does not compatible.
  • Page 119 • Connected network is Check network settings not available. and availability. • • Internal failure. Contact Masimo service. See Contacting Masimo on page 146. • • Incompatible version Upgrade to current Indicators on Docking of software on software versions. Station Continuously Flash Handheld and •...

  • Page 121: Chapter 8: Specifications

    Chapter 8: Specifications The following chapter contains specifications for the Radical-7 Handheld, compatible Docking Stations, and the Standalone system. Display Range Measurement Display Range (Functional Oxygen Saturation) 0% to 100% PR (Pulse Rate) 0 bpm to 240 bpm Pi (Perfusion Index) 0.00 to 20...
  • Page 122 Approximately two-thirds of the device measurements fell within +/- A of the reference measurements in a controlled study. Note: A functional tester cannot be used to assess the accuracy of Radical-7. www.masimo.com Masimo...

  • Page 123: Resolution

    0.1 g/dL 0.1 mmol/L 1 g/L SpCO SpMet 0.1% SpOC 1.0 ml/dL Electrical Radical-7 Battery Type Lithium ion Capacity 4 hours [8] Charge Time 6 hours* * When docked to Docking Station or Root. Docking Station AC Power 100 to 240 VAC, 47 to 63 Hz...

  • Page 124: Environmental

    Radical-7 Chapter 8: Specifications Docking Station Fuses UL Listed, Metric (5x20mm), rated 250 VAC, 2 Amp, Time Delay, 1500A breaking capacity Environmental Environmental Conditions Operating Temperature 0°C to 50°C (32°F to 122°F) Storage/Transport Temperature -40°C to 70°C [9] (-40°F to 158°F)

  • Page 125: Trending

    Radical-7 Chapter 8: Specifications Trending Sensitivity NORM, MAX, and APOD [10] Maximum of 96 hours trending at 2-second resolution. Alarms Technical Alarm Alarm Status Description Type Color High Priority Flashing red 571 Hz tone, 5-pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s Medium Priority Flashing 550 Hz tone, 3-pulse burst, pulse spacing: 0.375s,...

  • Page 126: Compliance

    Radical-7 Chapter 8: Specifications Item Description Pixels 480 dots x 272 dots Dot Pitch 0.25 mm Compliance EMC Compliance IEC 60601-1-2:2007 IEC 60601-1-2:2014 Safety Standards Compliance IEC 60601-1:2005/AMD1:2012 IEC 62304:2006/AMD1:2015 IEC 60601-1-6:2010/AMD1:2013 IEC 60601-1-8:2006/AMD1:2012 EN/ISO 80601-2-61:2011 EN 60601-1:2006/AMD1:2013 ANSI/AAMI ES60601-1:2005/A1:2012 CAN/CSA C22.2 No.

  • Page 127: Output Interface

    The digital interface for serial communication is based on the standard RS-232 protocol. See Handheld Back View on page 34. The Radical-7 by default always outputs ASCII 1 text data through the serial port, unless the user selects a different output mode. The Radical-7 serial interface is only available when the Radical-7 Handheld is properly attached to the Docking Station.
  • Page 128 No Connection Serial Interface Setup To interface with the Radical-7 and receive serial text data, connect a serial interface cable with a ferrite bead installed to the serial output connector located on the back of the Radical-7 Docking Station. See Handheld Back View on page 34. Once serial communication is established, packets of data are communicated at 1 second intervals.
  • Page 129 Volt. Calibrate the analog recording system to those levels before use. Nurse Call The Nurse Call feature is available when the Radical-7 is operating as a standalone. Nurse Call is based on the relay closing or opening depending on alarm, Low Signal IQ events, or both.

  • Page 130: Wireless Specifications

    Radical-7 Chapter 8: Specifications Parameter Specification Max voltage 100V DC or AC peak Max Current 100mA Wireless Specifications Communication (Wi-Fi) Type WLAN Radio: IEEE 802.11 a/b/g Frequency 2.4 GHz - 802.11b/g/n: 2412-2472 MHz 5.0 GHz - 802.11a/n: 5150-5250 MHz, 5250-5350 MHz,...
  • Page 131 Authentication Open System, Shared Key, Pre-Shared Key (PSK), 802.1X: LEAP, PEAP< TTLS, TLS, EAP-FAST Radio Compliance FCC ID: VKF-RAD7A or VKF-RAD7B FCC Model: Radical-7 FCC Title 47, Part 15 Canada* IC ID: 7362A-RAD7A or 7362A-RAD7B IC Model: VKF-RAD7A or VKF-RAD7B RSS-247 www.masimo.com...
  • Page 132 Radical-7 Chapter 8: Specifications Radio Compliance 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...

  • Page 133: Guidance And Manufacturer's Declaration-Electromagnetic Emissions

    Radical-7 Chapter 8: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Emissions Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
  • Page 134 Radical-7 Chapter 8: Specifications Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communication Equipment Test Band (a) Service (a) Modulation Maximum Distance Immunity Frequency (MHz) Power Test Level (MHz) (V/m) Pulse modulation 380-395 TETRA 400 18 Hz FM (c)
  • Page 135 Radical-7 Chapter 8: Specifications Test Band (a) Service (a) Modulation Maximum Distance Immunity Frequency (MHz) Power Test Level (MHz) (V/m) 5 240 Pulse 5 100-5 WLAN modulation 5 500 802.11 a/n 217 Hz 5 785 Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.

  • Page 136: Manufacturer's Declaration-Electromagnetic Immunity

    Radical-7 Chapter 8: Specifications 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.
  • Page 137 Radical-7 Chapter 8: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Portable and mobile RF communications equipment should be used no closer to any part of the ME Equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 138: Recommended Separation Distances

    Radical-7 Chapter 8: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ME Equipment is used exceeds the applicable RF compliance level above, the ME Equipment should be observed to verify normal operation.

  • Page 139: Symbols

    Radical-7 Chapter 8: Specifications Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 140 No parameter alarms (polyvinyl chloride) material Not made with natural rubber Caution latex Manufacturer Catalog number (model number) Date of manufacture Masimo reference number YYYY-MM-DD Storage temperature Serial number range Keep dry Fragile, handle with care Storage humidity Do not use if package is damaged...

  • Page 141: Citations

    7 days to 135 days old and weighing between 0.5 kg and 4.25 kg. Seventy-nine (79) data samples were collected over a range of 70% to 100% SaO and 0.5% to 2.5% HbMet with a resultant accuracy of 2.9% SpO and 0.9% SpMet. Contact Masimo for testing specifications. www.masimo.com Masimo...
  • Page 142 Plus or minus one standard deviation encompasses 68% of the population. [4] The Radical-7 has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2TM* simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70%-100%.

  • Page 143: Chapter 9: Service And Maintenance

    The following chapter contains information about cleaning, battery operation, performance verification, service, repair, and warranty. Cleaning The Radical-7 is a reusable device. The device is supplied and is intended to be used non-sterile. WARNING: To avoid electric shock, always turn off the Radical-7 and physically disconnect the AC power and all patient connections before cleaning.
  • Page 144 Estimated Run Times of Battery Power The following tables outline the estimated run times of the battery-powered Radical-7. The time estimates are based on a Radical-7 with fully charged batteries. The time estimates are also based on a Radical-7 with and without the back-light illuminated.

  • Page 145: Replacing The Fuses

    To test the performance of the Radical-7 following repairs or during routine maintenance, follow the procedure outlined in this chapter. If the Radical-7 fails any of the described tests, discontinue its use and correct the problem before returning the device back to the user.
  • Page 146 Perform the gestures outlined in Using the Touchscreen Interface. Alarm Limit Test Alarm Limit Test Connect a sensor to the Radical-7. Place the sensor on a finger to obtain an SpO value. Change the High SpO Alarm parameter to a value two points below the currently selected value.
  • Page 147 AC power. Verify that the Handheld Battery Charging indicator is illuminated. When the Radical-7 is fully charged, the Handheld Battery Charging indicator turns off. Turn on the Radical-7 on and verify that the Battery indicator shows a full charge. www.masimo.com Masimo...

  • Page 148: Repair Policy

    Warranty information, a copy of the invoice or other applicable documentation must be included. • Purchase order number to cover repair if the Radical-7 is not under warranty, or for tracking purposes if it is. • Ship-to and bill-to information.
  • Page 149 Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software.
  • Page 150 Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included.

  • Page 151: Appendix: Concepts Of Alarm Response Delay

    The overall alarm system delay time is graphically represented as t – t For more information about alarm response delay, refer to ISO 80601-2-61. www.masimo.com Masimo...

  • Page 153: Index

    Specifications • 127, 145 Cleaning • 141, 146 Analog Output Test • 145 Cleaning and Service Warnings and Appendix Cautions • 18 Concepts of Alarm Response Delay • 113, Compliance • 43, 44, 45, 124 Compliance Warnings and Cautions • 19 www.masimo.com Masimo...
  • Page 154 Radical-7 Index Concepts of Alarm Response Delay • 149 General Description for Oxygen Saturation (SpO2) • 22 Contacting Masimo • 114, 115, 116, 117, General Description for Perfusion Index (Pi) • 23 Contraindications • 10 General Description for Pleth Variability Customizing Trend Views •...
  • Page 155 PVi Histogram • 74, 75 Monitor Interface With SatShare • 39 PVi Settings • 67, 74 Navigating the Main Menu • 66 Radical-7 Battery • 53, 54, 84, 87 Nurse Call Test • 144 Radical-7 Messages • 105 rainbow Acoustic Monitoring Architecture •...
  • Page 156 111, 113 IMMUNITY to RF Wireless Sensor • 29 Communication Equipment • 132 Serial Interface Setup • 126 Testing with the optional Masimo SET Serial Interface Specifications • 37, 44, Tester • 144 45, 125, 145 Touchscreen Function Test • 144 Signal Extraction Technology®...
  • Page 157 Radical-7 Index Wi-Fi • 52, 84, 86, 117 Wireless Specifications • 128 www.masimo.com Masimo...
  • Page 160 35322/LAB-5475H-0819...

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