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

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  • Page 1 Radical-7 Operator's Manual...
  • Page 3 General knowledge of pulse oximetry and an understanding of the features and functions of Radical-7 are prerequisites for its proper use. Do not operate Radical-7 without completely reading and understanding these instructions.
  • Page 4 Patents: , Adaptive Probe Off Detection, APOD, 3D Alarm, Discrete Saturation Transform, DST, FastSat, FST, Masimo, Pulse CO-Oximeter, PVI, Radical-7, Root, rainbow, rainbow Acoustic Monitoring, RAM, rainbow Resposable, RDS, RRa, RRp, SatShare, SedLine, SET, Signal Extraction Technology, Signal IQ, SpCO, SpHb, and SpMet are federally registered trademarks of Masimo Corporation.
  • Page 5 © 20182019 Masimo Corporation www.masimo.com Masimo...

  • Page 7: Table Of Contents

    Chapter 1: Technology Overview ------------------------------------------ 31 Signal Extraction Technology (SET) ------------------------------------- 31 rainbow Pulse CO-Oximetry Technology® ----------------------------- 34 rainbow Acoustic Monitoring (RAM) Technology ---------------------- 42 Chapter 2: Radical-7 Descriptions ----------------------------------------- 47 General System Description -------------------------------------------- 47 Functionality of the Radical-7------------------------------------------- 47 Handheld ---------------------------------------------------------------- 49...
  • Page 8 Using the Touchscreen and Buttons ----------------------------------- 66 Using Screen Lock ------------------------------------------------------ 67 Using the Home Button ------------------------------------------------ 68 Standby and Power Off ------------------------------------------------- 68 Navigating the Radical-7 ----------------------------------------------- 69 About the Display View ------------------------------------------------ 70 Sensitivity Modes Overview -------------------------------------------- 81 Changing Sensitivity Modes -------------------------------------------- 82...
  • Page 9 Profiles Overview------------------------------------------------------ 145 Changing Profiles ----------------------------------------------------- 146 Replacing Factory Default Settings for Adult and Neo Profiles ------ 150 Powering Off the Radical-7 ------------------------------------------- 151 Chapter 6: Alarms and Messages --------------------------------------- 153 About Alarms --------------------------------------------------------- 153 Silencing the Alarms -------------------------------------------------- 153...
  • Page 10 Battery Operation and Maintenance ---------------------------------- 196 Performance Verification ---------------------------------------------- 200 Repair Policy ----------------------------------------------------------- 203 Return Procedure ------------------------------------------------------ 204 Contacting Masimo ---------------------------------------------------- 204 Appendix ----------------------------------------------------------------- 209 Concepts of Alarm Response Delay ----------------------------------- 209 Guidance and Manufacturer's Declaration- Electromagnetic Emissions ------------------------------------------------------------------------- 210...

  • Page 11: Radical-7 Contents

    Radical-7 Contents Index --------------------------------------------------------------------- 219 www.masimo.com Masimo...

  • Page 13: About This Manual

    About this Manual This manual explains how to set up and use the Radical-7® Pulse CO- Oximeter®. Important safety information relating to general use of the 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 14: Key Features

    Radical-7 Product Description 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. The Radical-7 provides graphical displays for plethysmographic waveform, respiratory waveform, Signal Identification and Quality Indicator (Signal IQ®).

  • Page 15: Indications For Use

    • Multi-gesture touchscreen interface. • Detachable portable Handheld for patient transport. • Remote alarm interface. Indications for Use The Masimo Radical-7 and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial www.masimo.com Masimo...

  • Page 16: Contraindications

    (SpMet®), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 and accessories have been validated and 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 17: Warnings And Cautions

    Safety Warnings and Cautions Warning: Do not use the Radical-7 if it appears or is suspected to be damaged. Warning: Do not start or operate Radical-7 unless the setup was verified to be correct.
  • Page 18 Warning: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Caution: Do not place the Radical-7 where the controls can be changed by the patient. Caution: When patients are undergoing photodynamic therapy they may be sensitive to light sources.

  • Page 19: Performance Warnings And Cautions

    Caution: Only use the AC power cable provided by Masimo. Using a different AC power cable could cause damage to Radical Docking Station. Check the power cord and plug to ensure that it is intact and undamaged.
  • Page 20 Warnings and Cautions Warning: Do not place containers with liquids on or near Radical-7. Liquids spilled on Radical-7 may cause it to perform inaccurately or fail. Warning: Radical-7 is intended only as an adjunct device in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions.
  • Page 21 Radical-7 Warnings and Cautions Warning: Inaccurate SpHb and SpOC readings may be caused by: • Improper sensor application • Intravascular dyes such as indocyanine green or methylene blue • Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
  • Page 22 Warning: SpCO readings may not be provided if there are low arterial saturation levels or elevated methemoglobin levels. Warning: If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check Radical-7 for proper functioning. Warning: Inaccurate respiration rate measurements may be caused by: •...
  • Page 23 Warning: ORI is not intended as a replacement for SpO2 monitoring, PaO2 monitoring, or as a sole indicator of the patient condition. Caution: ORI measurements are only displayed on Root® when Radical-7 has been configured for ORI and is communicating to Root.
  • Page 24 Caution: The device must be configured to match your local power line frequency to allow for the cancelation of noise introduced by fluorescent lights and other sources. Caution: Do not place the Radical-7 against a surface that may cause the alarm to be muffled. Caution: Ensure the speaker is not covered.
  • Page 25 Note: Use the Radical-7 in accordance with Environmental Specifications section in this manual. 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.
  • Page 26 Note: It is recommended that Radical-7 battery is fully charged prior to use. Note: Always charge Radical-7 when it is not in use to ensure that the Radical-7 battery remains fully charged. Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the battery.

  • Page 27: Cleaning And Service Warnings And Cautions

    Cleaning and Service Warnings and Cautions Warning: Do not adjust, repair, open, disassemble, or modify Radical-7. Injury to personnel or equipment damage could occur. Return Radical-7 for servicing. Warning: Electrical Shock Hazard: The battery should be installed and/or removed from the Radical-7 by qualified personnel only.
  • Page 28 Refer servicing to qualified service personnel trained in the repair of this equipment. Caution: Do not submerge Radical-7 in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method.

  • Page 29: Compliance Warnings And Cautions

    Radical-7 Warnings and Cautions as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. Compliance Warnings and Cautions Warning: Do not incinerate battery.
  • Page 30 Radical-7 Warnings and Cautions harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
  • Page 31 Radical-7 Warnings and Cautions 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 33: 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.
  • Page 34 Radical-7 Chapter 1: Technology Overview Masimo rainbow SET® Parallel Engines This figure is for conceptual purposes only. Masimo SET® DST This figure is for conceptual purposes only. General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: www.masimo.com...
  • Page 35 SpO and pulse rate. Functional Oxygen Saturation (SpO2) The Radical-7 is calibrated to measure and display functional oxygen saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen.

  • Page 36: Rainbow Pulse Co-Oximetry Technology

    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 37 This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25 mW. The detector receives the light, converts it into an electronic signal and sends it to the Radical-7 for calculation.
  • Page 38 Light Emitting Diodes (LEDs) (7 + wavelengths) Detector Once the Radical-7 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient’s functional oxygen saturation (SpO [%]), blood levels of carboxyhemoglobin (SpCO [%]), methemoglobin (SpMet [%]), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (PR).
  • Page 39 Radical-7 Chapter 1: Technology Overview In the case of SpO , different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between...
  • Page 40 Radical-7 Chapter 1: Technology Overview General Description for Total Hemoglobin (SpHb) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make its SpHb measurement. The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adults and pediatric patients.
  • Page 41 (SpO ) as measured by a pulse oximeter is given by: = 1.02 x HbO When calculating oxygen content (SpOC), the Radical-7 will use SpfO ™ if available instead of SpO . SpfO is the measured fractional arterial oxygen saturation.
  • Page 42 Radical-7 Chapter 1: Technology Overview General Description for Carboxyhemoglobin (SpCO) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carboxyhemoglobin concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO measurement.
  • Page 43 Radical-7 Chapter 1: Technology Overview The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry device or through a patient cable.

  • Page 44: Rainbow Acoustic Monitoring (Ram) Technology

    *Available only on Root display 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 45 Radical-7 Chapter 1: Technology Overview can be processed to produce a respiration rate, measured as breaths per minute. 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].
  • Page 46 Radical-7 Chapter 1: Technology Overview Signal Envelope RRa Estimation Processing Detection Digital signal to respiratory measurement Patient The generation of respiratory sounds is primarily related to turbulent respiratory airflow in upper airways. Sound pressure waves within the airway gas and airway wall motion contribute to the vibrations that reach the body surface and are recorded as respiratory sounds.
  • Page 47 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 48 Radical-7 Chapter 1: Technology Overview [4] Pastercamp H, Kraman SS, Wodicka GR. Respiratory sounds – Advances beyond the stethoscope. Am J Respir Crit Care Med 1977; 156: 974-987. [5] Gavriely N, Cugell DW. Airflow effects on amplitude and spectral content of normal breath sounds. J Appl Physiol 1996; 80: 5-13.

  • Page 49: Chapter 2: Radical-7 Descriptions

    Device Patient Cable Sensor For a list of compatible sensors and cables, visit http://www.masimo.com. Functionality of the Radical-7 The Radical-7 provides the functionality of three devices in one: Handheld Pulse CO-Oximeter The Radical-7 is a fully featured Handheld. www.masimo.com Masimo...
  • Page 50 The sensor cable connector is located on the Handheld. Standalone Pulse Oximeter The Radical-7 is a fully featured Standalone Pulse-Oximeter, and Acoustic Monitor. The Handheld snaps into the Docking Station to provide a fully featured standalone monitor.

  • Page 51: Handheld

    Handheld Pulse CO-Oximeter for spot checks. Handheld Front Panel The following figure numbers and corresponding table describes the hardware features of the Radical-7. www.masimo.com Masimo...
  • Page 52 Profile Screen. See Chapter 5: Profiles on page 145. 4. Power button To turn on the Radical-7, press the Power button. To place Radical-7 in standby, press and hold the Power button for two (2) seconds. To turn off, press and hold the button for eight (8) seconds.
  • Page 53 8. Patient Cable Connector Connect a patient cable or a direct cable sensor into the Radical-7. Caution: Refer to the Directions for Use for the sensor before applying it on patients. Handheld Back Panel...
  • Page 54 Radical-7 Chapter 2: Radical-7 Descriptions Item and Description 1. Connector The Handheld interfaces with the Docking Station through this connector. 2. Pole Clamp The optional Pole Clamp accessory attaches to this holder. See the directions for use of the Pole Clamp accessory for attachment instructions.

  • Page 55: Standalone

    Radical-7 Chapter 2: Radical-7 Descriptions Standalone When the Handheld is placed into the Docking Station, they become a full-featured standalone system. In this manual, when the Handheld and Standalone the Docking Station are connected, they are referred to . The Standalone acts as a battery charger for the Handheld and has AC power connection capabilities.
  • Page 56  Docking indicator Standalone Front Panel The following figure and corresponding text review the features of the Radical-7 Standalone. Note that when the Standalone is turned on, all indicator LEDs initially turn on and off at start up. www.masimo.com Masimo...
  • Page 57 The Visual Alarm indicator is illuminated when an alarm condition is active and the Alarm Status Indicator is shown. 4. AC Power Indicator The AC Power indicator is illuminated when the Radical-7 Docking Station is plugged into AC line power. 5. Docking Indicator www.masimo.com...
  • Page 58 Use the Serial Output connector with a ferrite bead installed to connect 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 59 The Power Entry module contains the input connector for AC power and two fuses. The AC input provides power to the system from the AC line. Always connect the Radical-7 to the mains power for continuous operation and/ or battery recharging. Note: Use the power cord as the means to disconnect the device from the mains power supply.

  • Page 60: Monitor Interface With Satshare

    5. Equipotential Ground connector Use the Equipotential Ground connector for grounding. Monitor Interface With SatShare The Radical-7 has a unique SatShare interface that links to most existing multi-parameter patient monitors through a SatShare cable. • Upgrades any approved and validated monitor to Masimo SET®...

  • Page 61: Chapter 3: Setup

    Verify that the power source can provide an adequate power rating as indicated on the rear panel of the Docking Station. • The Radical-7 is designed to operate on 100 to 240VAC, 47-63 • The Radical-7 is rated at 55 VA max.

  • Page 62: Setting Up The Docking Station

    Setting Up the Docking Station Place the Docking Station on a stable hard flat surface near the patient. Always place the Radical-7 on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the Radical-7. Make sure that the Radical-7 speaker is not covered to avoid a muffled alarm sound.

  • Page 63: Setting Up For Philips, Agilent, Or Hp Vuelink

    In order for the plethysmographic waveform to be displayed on the VueLink compatible monitor, and for the VueLink monitor to convey alarm conditions measured by the Radical-7, the VueLink compatible monitor must be properly configured. See instructions for use provided with the VueLink compatible Compliance monitor and the VueLink module.

  • Page 64: Setting Up For Spacelabs Flexport

    Specifications on page 186. Setting Up and Using SatShare Parameter values from the Radical-7 can be displayed on a multi- parameter monitor through the SatShare feature. The SatShare feature provides an ideal, simulated plethysmographic waveform that corresponds to the parameter values determined the by Radical-7. This...
  • Page 65 Set the averaging time for the multi-parameter monitor to its lowest setting (or fastest response). The ideal waveform for the Radical-7 requires additional averaging by the monitor. If the averaging time of the multi-parameter monitor is not changed, the time to display physiological changes in saturation on the monitor is increased with SatShare.
  • Page 66 Radical-7 and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical-7 are to be considered the correct values. It is possible to use the Radical-7 with SatShare while the Radical-7 is not connected to AC power.

  • Page 67: Chapter 4: Operation

    Chapter 4: Operation The following chapter contains information about using the Radical-7. www.masimo.com Masimo...

  • Page 68: Using The Touchscreen And Buttons

    153. 4. Home button Display View To return to the press Home. 5. Power button To turn on the Radical-7, press the Power button. To turn off, press and hold the button for more than 2 seconds www.masimo.com Masimo...

  • Page 69: Using Screen Lock

    Radical-7 Chapter 4: Operation Using Screen Lock Screen Lock When turned on, the feature may prevent unintentional Display View interaction with Using the Screen Lock feature Display View When turned on, any interaction with the triggers the Screen Lock feature.

  • Page 70: Using The Home Button

    To return to Display View using the Home button • From any screen, press Home. Standby and Power Off To put Radical-7 in Standby Mode or to Power Off, follow these steps: State Description Press and hold the Power Button for two (2) seconds until a single audible tone sounds.

  • Page 71: Navigating The Radical-7

    Radical-7 Chapter 4: Operation Navigating the Radical-7 Display View Main Menu Navigate the Radical-7 screens via the or the Display View The following is the primary interactive screen that the user views. To access the Main Menu screen • Touch the gear icon at the lower right corner of the display.

  • Page 72: About The Display View

    Radical-7 Chapter 4: Operation About the Display View Display View consists of different areas: Status Bar. See About the Status Bar on page 72. Parameter Display. See Changing the Size of Parameter Values page 73. www.masimo.com Masimo...
  • Page 73 Radical-7 Chapter 4: Operation Waveform and Trend Views Trend Field. See on page 76. Accessing the Main Menu Small Parameter View. See on page 84. www.masimo.com Masimo...
  • Page 74 Radical-7 Chapter 4: Operation About the Status Bar Display View The Status Bar is visible on the top portion of the Status Bar Access additional screens, more information, or toggle features by touching directly on any of the following indicators in the Status Bar.
  • Page 75 Radical-7 Chapter 4: Operation Changing the Size of Parameter Values To change the size of parameter values on the Display View Small Parameter v On the iew, touch and hold any one of the parameters, as shown above. When the parameter value dims, shakes, and grows in size, drag...
  • Page 76 Radical-7 Chapter 4: Operation Touch the Trend Field, as shown below. The following screen appears. Swipe up or swipe down the available options. Touch on the desired option. www.masimo.com Masimo...
  • Page 77 Radical-7 Chapter 4: Operation Trend Field displays trend data specific to the option that was selected. Pulse Bar Pulse Bar is a visual indicator that conveys the detection of pulse and the Signal IQ (SIQ) displayed on each individual pulsation. The height of...
  • Page 78 Radical-7 Chapter 4: Operation Waveform and Trend Views The following section contain information about trends and waveforms Trend Field Display View available from the on the screen. The following are examples of some of the views that are available. Pleth + Sig IQ + Acoustic View Shows the parameter values on the top of the screen.
  • Page 79 Radical-7 Chapter 4: Operation Signal IQ Indicators The Signal IQ (SIQ), displayed on each individual pulsation, is conveyed by vertical bars, as shown below. The height of the bar provides an assessment of the confidence in the measurement displayed. Acoustic Waveform View Shows the parameter values on the top of the screen.
  • Page 80 Radical-7 Chapter 4: Operation Pleth + Sig IQ + Acoustic View Shows the parameter values on the top of the screen. The waveform is Small Parameter located below the parameter values. The view is located along the bottom of the screen. This view contains the Pleth waveform, signal quality indications, and acoustic waveform.
  • Page 81 Radical-7 Chapter 4: Operation With a pinch gesture, using two fingers, the user can zoom in and out of Trend Field the quick trend data within the About Events Feature The Events feature provides graphical display of parameter or measurement alarms and non-clinical exception messages. This feature is only viewable in the Full Trend screen;...
  • Page 82 Radical-7 Chapter 4: Operation Specific to parameters • In Vivo and measurements Change in In offset shown in Full Trend Vivo offset. changed: -1.9 screen. • Replace sensor Whenever in Full Trend Non-clinical • Low battery Yellow screen. exception. •...

  • Page 83: Sensitivity Modes Overview

    ( 12:11:32 PM and its timestamp ( 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 www.masimo.com Masimo...

  • Page 84: Changing Sensitivity Modes

    Radical-7 Chapter 4: Operation Display menu by touching on the indicator in the upper left corner of the View . The sensitivity levels are as follows: • NORM (Normal Sensitivity) NORM is the recommended sensitivity mode for patients who are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as an intensive care unit (ICU).
  • Page 85 Radical-7 Chapter 4: Operation Display View Press the indication on the top left of the Main Menu Profiles Alternatively, from the , touch the icon. From Profiles screen, select the desired mode by scrolling up or down. Then select OK.

  • Page 86: Accessing The Main Menu

    Radical-7 Chapter 4: Operation Accessing the Main Menu Main Menu Display View To access from the , touch the gear icon on the Small Parameter View bottom right corner of the Navigating the Main Menu • Main Menu From the...
  • Page 87 Radical-7 Chapter 4: Operation Device Settings Device Settings on page 116. Parameter Settings Parameter Settings on page 87. Profiles Changing Profiles on page 146. 3D Alarms 3D Alarms on page 157. Trends Trends Trend Field on page 127 and page 73.
  • Page 88 Radical-7 Chapter 4: Operation About About on page 141. www.masimo.com Masimo...

  • Page 89: Parameter Settings

    Radical-7 Chapter 4: Operation Parameter Settings Parameter Settings The following is an example of the screen. Only parameters that have been loaded onto the system will be visible. To access any of the available parameter setting screens Parameter Settings From the screen, to access the desired parameter, flick the on-screen icons left or right.
  • Page 90 Radical-7 Chapter 4: Operation Perfusion Index (PI) Settings on page 99. SpCO Settings on page 108. SpMet Settings on page 109. SpOC Settings on page 111. Respiration Rate (RR) on page 101 About Parameter Information Additional information about each parameter is available.
  • Page 91 Radical-7 Chapter 4: Operation About screen appears for the selected parameter. In Vivo Adjustment Overview The In Vivo Adjustment feature lets clinicians manually adjust one or more clinical parameters to match that of a corresponding laboratory reference for continuous trending. To remind clinicians that the feature is active, an offset value displays alongside the adjusted parameter value.
  • Page 92 Radical-7 Chapter 4: Operation Offset Value When In Vivo Adjustment is activated for a specific parameter, the offset value appears beneath that specific parameter. A positive value means that the displayed parameter value has been increased (according to a laboratory reference value as entered by a clinician) and a negative value means the displayed parameter value has been decreased (according to a laboratory reference value as entered by a clinician).
  • Page 93 Radical-7 Chapter 4: Operation SpO2 Settings Access any of the following options: Alarms for SpO2 on page 91. Additional Settings for SpO2 on page 92. About Parameter Information on page 88. Alarms for SpO2 Alarms From the screen, change any of the following options:...
  • Page 94 Radical-7 Chapter 4: Operation Factory Configurable Options Description Default Options Settings Sets the Rapid Desat limit threshold to the selected amount below the Low Alarm Rapid Limit. When SpO value falls Off, -5%, or - -10% Desat below rapid desat limit the...
  • Page 95 FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend. When the Radical-7 is set to FastSat , the averaging algorithm evaluates all the saturation values providing an averaged saturation value that is a better representation of the patient’s current oxygenation status.
  • Page 96 Radical-7 Chapter 4: Operation In Vivo for SpO2 In Vivo From the screen, change any of the following options: Options Description Factory User Configurable Default Settings Settings In Vivo Enabled On or Off Adjustment Overview on page 89. In Vivo...
  • Page 97 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings High The High Limit is 17.0 g/dL 2.0 g/dL to 24.5 g/dL in Limit upper threshold that steps of 0.1 g/dL, or Off (170 g/L) triggers an alarm.
  • Page 98 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings The Low Limit is 7.0 g/dL Off, or 1.0 g/dL to 23.5 Limit lower threshold that g/dL in steps of 0.1 g/dL (70 g/L) triggers an alarm. (Off, or 1 g/L to 248 g/L (4.0...
  • Page 99 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Averaging The length of time over which Medium Short, Time the system calculates the Medium, or average of all data points. Long Calibration Provides an arterial or venous...
  • Page 100 Radical-7 Chapter 4: Operation In Vivo for SpHb In Vivo From the screen, change any of the following options: Options Description Factory User Configurable Default Settings Settings In Vivo In Vivo On or Off Adjustment Calibration Overview on page 89.
  • Page 101 Radical-7 Chapter 4: Operation Options Description Factory Options Default Settings High The High Limit is upper 140 bpm 35 bpm to 235 Limit threshold that triggers an bpm, in steps of 5 alarm. The Low Limit is lower 50 bpm...
  • Page 102 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings High The High Limit is upper Step size: Limit threshold that triggers an 0.04 to 0.09 in alarm. steps of 0.01 0.10 to 0.90 in steps of 0.10...
  • Page 103 Respiration Rate (RR) The Radical-7 can determine respiration rate (RR) either by the acoustic signal (RRa) or by the plethysmographic waveform (RRp). RRp Settings When using a pulse oximetry or pulse CO-Oximetry sensor with the Radical-7, respiration rate can be determined by the plethysmographic waveform (RRp).
  • Page 104 Radical-7 Chapter 4: Operation Note that the Radical-7 can monitor RRa or RRp but not both simultaneously. RRp is active under the following conditions: • RRp is installed on the Radical-7. • Dual Rainbow cable is disconnected. • Pulse oximetry or pulse CO-Oximetry sensor is connected.
  • Page 105 Radical-7 Chapter 4: Operation Options Description Factory Configurable Options Default High The High Limit is upper 30 breaths 6 breaths per minute Limit threshold that triggers an to 69 breaths per alarm. minute minute, or Off The Low Limit is lower...
  • Page 106 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. RR Settings From the...
  • Page 107 Radical-7 Chapter 4: Operation Options Description Factory Configurable Options Default Settings High Limit The High Limit is upper 6 to 69 breaths per threshold that triggers breaths minute in steps of 1 an alarm. breaths per minute, minute or Off...
  • Page 108 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Averaging The length of time over Slow Trending, No, Time which the system calculates Fast, Medium, or the average of all data Slow points. Freshness The duration of time that,...
  • Page 109 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings High The High Limit is upper 2 to 99, in steps of Limit threshold that triggers an 1, or Off alarm. When set to Off, alarms are disabled.
  • Page 110 Radical-7 Chapter 4: Operation SpCO Settings SpCO Setting From the s screen, access the following screens: SpCO Alarms on page 108. About Parameter Information on page 88. SpCO Alarms SpCO Settings From the screen, access the following screens: Options Description...
  • Page 111 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings In Vivo Adjustment Enabled On or Off Overview on page 89. In Vivo Adjustment Offset ± 9% in steps of Overview Amount on page 89. 0.1% SpMet Settings...
  • Page 112 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings High The High Alarm Limit is 1% to 2% in steps Limit upper threshold that of 0.1% triggers an alarm. 2.5% to 99.5% in steps of 0.5%, or The Low Alarm Limit is Off, 0.1% to 2.0% in...
  • Page 113 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Offset Helps offset individual patient ±3% in steps Amount bias that is expected when of 0.1% comparing a noninvasive measurement to a laboratory reference. SpOC Settings SpOC Settings...
  • Page 114 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings The Low Limit is the lower Off, or 1% to 33% Limit threshold that triggers an in steps of 1% alarm. ORI Settings ORI Settings screen can only be accessed on Root. From the...
  • Page 115 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Trending The Trending Down Alarm On/Off Down is displayed when a rapid Alarm decrease in ORI is measured. Sounds Sounds From the screen, change any of the following options:...
  • Page 116 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Settings Default Settings Pulse Sets the volume Level 3 Off, Level 1 to 4 Tone of the tone that Volume conveys the pulse rate. www.masimo.com Masimo...
  • Page 117 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Settings Default Settings Silence Length of time 30, 60, 90, or 120 seconds Duration that the audible seconds All Mute is set to (see alarm remains Access Control on page 117), muted.
  • Page 118 Radical-7 Chapter 4: Operation Device Settings Device Settings The following is an example of the screen. Device Settings From the screen, access any of the following options: Screen Orientation on page 123. Localization on page 121. WiFi on page 124.
  • Page 119 Radical-7 Chapter 4: Operation Access Control Password Screen Access Control screen is password-protected. Using the Password screen www.masimo.com Masimo...
  • Page 120 Radical-7 Chapter 4: Operation Password On the screen, enter the following numbers: 6 2 7 4 No numbers will be displayed, only asterisks (****). Touch Enter. To undo numbers, touch Backspace. Settings Access Control From the screen, change any of the following options: www.masimo.com...
  • Page 121 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings Allows user to select a specific Profile to be loaded the next time that Previous Profile, the unit is powered on. Adult, Pediatric, Power This Profile can be one of...
  • Page 122 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings When set to 3 or 4, 3 or 4 Lock shows dimly lit in the Alarm Alarm Volume section of 3, 4, or Off Volume the Alarms Menu screen and cannot be changed.
  • Page 123 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings Press Save to load all Saves pre-configured Save as profiles for neonatal device configuration patients settings to neonatal profile. Press Restore to Options are restored to Factory factory values.
  • Page 124 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Time Zone Setting based on A (UTC+1hr) Choose local Coordinated Universal time zone Time (UTC). settings. Date Set the format of the MM/DD/YYYY MM/DD/YYYY Format date display on the DD/MM/YYYY Display View.
  • Page 125 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Time Manually set the hour 12-hour Choose hour and minute, AM or PM, if format and minute. Auto Set Date/Time is Off. Screen Orientation Screen Orientation From the...
  • Page 126 (180 degree) viewing position WiFi When the Radical-7 is connected to a WiFi network, the Wifi icon located About on the Status Bar conveys the strength of the Wifi connection. See the Status Bar on page 72.
  • Page 127 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings WiFi Enables or disables the On or Off wireless connection Additional fields in the Wifi screen provide information about WiFi connection. These additional fields are read only and not configurable.
  • Page 128 Radical-7 Chapter 4: Operation Options Description Factory User Default Configurable Settings Settings Brightness The slider option adjusts the Level 1 to 4 brightness level of the display and provides a sample of the brightness level. Device Output Device Output From the...
  • Page 129 Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings Depending on the Analog Pleth, SIQ, 0V configuration, the following Output, 1V Output, parameters are output 0% to 100%, continuously on the Analog 50% to 100%, 1 and Analog 2.
  • Page 130 Radical-7 Chapter 4: Operation About Trend Views There are different ways to view trend information. The following is an Display example of trend information for SpO as it appears within the View screen. The following is an example of trend information for SpO...
  • Page 131 Radical-7 Chapter 4: Operation Display View Trend Field From the , in the , touch the icon as shown below. Full Trend screen From the , touch the icon as shown below. Using the Events Feature The Events feature provides graphical display of parameter or measurement alarms and non-clinical exception messages.
  • Page 132 Radical-7 Chapter 4: Operation Color of Visibility Description Example Event Messages Circle • Parameter or • SpCO high measurement Specific to parameters alarm. • PR low and measurements shown in Full Trend • In Vivo Change in In screen. offset Vivo offset.
  • Page 133 Radical-7 Chapter 4: Operation If there are two (2) parameters and/or measurements displayed in the Full Trend screen, then only Events related to those parameters and/or measurements will be visible. Using the same example, tapping on the red circle reveals a message box...
  • Page 134 Radical-7 Chapter 4: Operation Manipulating View of Trend Data Full Trend On the screen, with a pinch gesture, using two fingers, the user can zoom in and out of the trend time scale. Trend The user can add parameters to the...
  • Page 135 Radical-7 Chapter 4: Operation To view past patient trend data, swipe the trend display to the left or to the right. Trend view, press the Home button. To exit a Changing the Time Interval of Trend Data Users can change the time interval of trend data. The time options that can be selected are 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, or 24 hours.
  • Page 136 Radical-7 Chapter 4: Operation Display View Trend Field Full Trend From the , in the , or from the Time Interval screen, touch the icon. Scroll up or down to select a time interval. 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.
  • Page 137 Radical-7 Chapter 4: Operation Trend Field The Histogram icon appears along the top of the , as shown in the following example for SpO Histogram Touch the icon. Trend data displays as a histogram. To turn off the Histogram feature www.masimo.com...
  • Page 138 Radical-7 Chapter 4: Operation • Trends Touch the icon, as shown. Changing Histogram Settings Users can change the ranges of bins in the histogram view for each individual parameter displayed. To access the histogram settings for any of the available parameters:...
  • Page 139 Radical-7 Chapter 4: Operation Touch any to change the range values. Touch and drag the markers to adjust the range values. When finished, touch the back arrow and select OK. Changing Trend Settings There are several ways to access and then change the maximum value and the minimum value of the Y axis for any of the available parameters.
  • Page 140 Radical-7 Chapter 4: Operation Trends From the screen, touch any of the available parameters. Parameter Settings Alternatively, from any screen, touch the Trends icon. Display View Full Trend Alternatively, from the or from the view, touch the Y axis range on the left side of the screen as shown.
  • Page 141 Radical-7 Chapter 4: Operation When viewing trends for an additional parameter, the Y axis range appears on the right side of the screen. To change the trend settings for any of the available parameters Touch the slider for the Y-axis maximum or the Y-axis minimum.
  • Page 142 Radical-7 Chapter 4: Operation Select the desired setting by scrolling up or down. When finished, select OK. Deleting Trend Data The user can delete patient trend data that has been stored on the Radical-7. To delete patient trend data Trends...
  • Page 143 Radical-7 Chapter 4: Operation Trend Settings From the screen, touch Clear, and then touch OK. This deletes all stored trend data. About About Parameter Information For information about parameters, see page 88. About From the screen, view any of the following options:...
  • Page 144 Docking If docked, displays the current software version of the Station Docking Station. Visualization When the Radical-7 is connected to Root, the Radical-7 provides a supplemental visualization of the alarm status for the connected Masimo medical technologies. www.masimo.com Masimo...
  • Page 145 Radical-7 Chapter 4: Operation Color Description Table This visualization displays a human body on the Radical-7 device when it is connected to Root. Colors are used to represent the status of monitoring and the alarms: Color Description Gray No monitoring...
  • Page 146 Radical-7 Chapter 4: Operation Parameter or Measurement Area Displayed on Visualization Screen Vascular SpHb Vascular SpMet Vascular SpCO Lung Lung SpfO Lung RRp* Lung SpOC PSI** Brain *CE marked only. Not available in the USA. **For use with SedLine® Sedation Monitor, upon availability www.masimo.com...

  • Page 147: Chapter 5: Profiles

    Chapter 5: Profiles The Radical-7 can be configured for various patient types. Profiles Overview Profiles The Radical-7 contains a screen, which lets the user customize different settings for different patient populations: • Adult Adult profile is the factory default profile. Displays in the Status...

  • Page 148: Changing Profiles

    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. Access To restore all Radical-7 settings to factory default settings, see Control on page 117.
  • Page 149 Radical-7 Chapter 5: Profiles • Profiles The first way is by the touching the shortcut in the Status Bar, as show below. • Profiles Settings Another way to access the screen is by pressing Profile button, as shown below. www.masimo.com...
  • Page 150 Radical-7 Chapter 5: Profiles • Main Menu Profiles Alternatively, from the screen, touch the icon. To change Patient Type Patient Type From the Profile screen, touch the field. www.masimo.com Masimo...
  • Page 151 Radical-7 Chapter 5: Profiles Select the desired Patient Type by scrolling up or down. When finished, touch OK. To confirm selection, check the Status Bar. Profiles From the screen, change any of the following options: Options Description Factory User Default...

  • Page 152: Replacing Factory Default Settings For Adult And Neo Profiles

    Profile button changes to the same blue or pink color respectively. Profiles Overview on page 145. A user can also load preferred profile configurations into the Radical-7 using a separate tool. To change the factory default settings for Adult or Neonatal profile settings Make the preferred changes to any of the Radical-7 settings.

  • Page 153: Powering Off The Radical-7

    Confirm the changes by powering off and powering on the Radical-7 and then verifying settings. Powering Off the Radical-7 When turning off the Radical-7, the device remembers the preferred settings. To turn off the Radical-7 Press and hold the button for more than 2 seconds.
  • Page 154 Radical-7 Chapter 5: Profiles To confirm the shutdown process, the following screen appears. www.masimo.com Masimo...

  • Page 155: Chapter 6: Alarms And Messages

    Chapter 7: Troubleshooting For more information, see on page 171. About Alarms The Radical-7 visually and audibly indicates alarm conditions that the system detects. Audible alarms may be silenced, without affecting the Warnings and Cautions operation of visual alarms. See on page 15.
  • Page 156 Radical-7 Chapter 6: Alarms and Messages The following is an example of a visual alarm for an exception message: The following is an example of a typical alarm due to parameter limit violation. To silence or dismiss alarms: • Touch Silence (the highlighted area of the Status Bar).
  • Page 157 Radical-7 Chapter 6: Alarms and Messages To silence audible alarms When an audible 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...

  • Page 158: Adaptive Threshold Alarm (Ata) Feature

    Radical-7 Chapter 6: Alarms and Messages Adaptive Threshold alarm (ATA) Feature The Adaptive Threshold Alarm (ATA) feature is an optional feature that provides continuous SpO surveillance while allowing the clinician a useful tool to help reduce the frequency of audible alarms.

  • Page 159: 3D Alarms

    Radical-7 Chapter 6: Alarms and Messages it also serves as absolute low alarm limit protection. SpO values exceeding the Rapid Desat low alarm limit, whether rapid or not, will activate an audible alarm. The user can change the Rapid Desat default setting from 5% to 10%.
  • Page 160 Radical-7 Chapter 6: Alarms and Messages typically established at a considerable change from the patients’ baseline saturation level. However, in select patient populations, substantial desaturation events that exceed a typical low alarm limit threshold may be preceded by a cycle of transient desaturations over a limited...
  • Page 161 (delta) over a specific period of time. Perfusion Index gives an indication of the level of perfusion at the monitored site. The Radical-7 measures perfusion at the SpO site by comparing the pulsatile signal to the non-pulsatile signal, and expressing that ratio as a percentage.
  • Page 162 The PI Delta provides an audible and visual alert to important changes in perfusion compared to the patient’s baseline PI rate. The baseline is set by the Radical-7 once the user has enabled the alarm. The baseline is 30 seconds of currently averaged PI. The feature includes a user-selectable PI Delta Alarm.

  • Page 163: Messages

    Radical-7 Chapter 6: Alarms and Messages Options Description Factory User Configurable Default Settings Settings Perfusion Index On or Off (PI) Delta Alarm Baseline Overview on page 159. Perfusion Index Baseline Off, or PI (PI) Delta Alarm baseline Overview on page 159.
  • Page 164 Radical-7 Chapter 6: Alarms and Messages Replace Sensor Message Message: • (Pulse CO-Ox) Replace Sensor , or • (RAM) Replace Sensor Reusable sensor has used all its available monitoring time, sensor is non- functional, or defective sensor. Next steps: Replace sensor.
  • Page 165 Next steps: Replace with a proper Masimo sensor. Sensor is attached to a device without an appropriate parameter installed. Next steps: Use a compatible sensor. Contact your local Masimo Representative to learn more about optional parameter upgrades. Incompatible Adhesive Sensor Message Message: •...
  • Page 166 Next steps: Place a Masimo Optical Light Shield over the sensor. Incorrect monitor line frequency setting (Hz). Next steps: Adjust the Line Frequency to the correct Hz setting. See Device Settings on page 116.
  • Page 167 Radical-7 Chapter 6: Alarms and Messages RAM unable to collect pulsing through RAM Sensor. Next steps: Ensure proper sensor application. Check that no object is pulling on the sensor cable causing the sensor to peel off. RAM Sensor Initializing Message...
  • Page 168 Next steps: Ensure proper sensor application. Check sensor to see if it is Successful Monitoring working properly. If not, replace the sensor. See for SpHb on page 38. Speaker Failure Message Device requires service. Next steps: Contact Masimo Tech Support. Chapter 9: Service and Maintenance on page 195. www.masimo.com Masimo...
  • Page 169 Radical-7 Chapter 6: Alarms and Messages Invalid Parameter Alarm Message Denoted by dashes shown as parameter value. Unable to provide a SpO2 or PR parameter value. Next steps: Check patient's vital condition. No Cable Connected Message Message: • (Pulse CO-Ox) No Cable Connected , or •...
  • Page 170 Radical-7 Chapter 6: Alarms and Messages Sensor is disconnected from patient cable. Sensor connected upside down into patient cable. Next steps: Check to see if the sensor LED is flashing. Disconnect and reconnect the sensor. If the LED fails to operate, replace the sensor.
  • Page 171 Radical-7 Chapter 6: Alarms and Messages Sensor not connected to patient properly. Sensor is damaged. Next steps: Properly reapply the sensor on the patient and reconnect the sensor to the device or patient cable. If the sensor is damaged, replace the sensor.
  • Page 172 Radical-7 Chapter 6: Alarms and Messages • (RAM) Adhesive Near Expiration Disposable sensor has less than 10% active monitoring life remaining. Next steps: Replace with new disposable sensor. www.masimo.com Masimo...

  • Page 173: Chapter 7: Troubleshooting

    Chapter 7: Troubleshooting The following chapter contains information about troubleshooting the Radical-7 system. Troubleshooting Measurements Safety Warnings and Cautions on page 15. Signal IQ (SIQ) The Signal IQ provides an indicator of the assessment of the confidence in the displayed SpO value.
  • Page 174 Chapter 7: Troubleshooting • Check the sensor and ensure proper sensor application. The sensor must be well secured to the site for the Radical-7® Pulse CO-Oximeter® to maintain accurate readings. Misalignment of the sensor’s emitter and detector can result in smaller signals and cause erroneous readings.
  • Page 175 Radical-7 Chapter 7: Troubleshooting Low Perfusion It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation This "localized hypoxemia" may result from the metabolic demands of other tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral hypoperfusion.
  • Page 176 Radical-7 Chapter 7: Troubleshooting Unexpected SpO2, SpCO, SpMet, or SpHb Reading • Low SIQ or PI values. Next steps: Reposition sensor to site with strong SIQ and PI. Average readings taken from three different sites to improve accuracy. Submit blood sample for laboratory CO-Oximetry test for comparison.

  • Page 177: Troubleshooting The Radical-7

    SpCO parameter has not yet stabilized during initial startup Next steps: Verify proper sensor and sensor size for the patient. Allow time for parameter reading to stabilize. Troubleshooting the Radical-7 Chapter 6: Alarms and Messages For more information, see on page 153.
  • Page 178 Internal failure. Alarm Silence Next steps: To silence an alarm, press the button. If alarm continues to sound, turn off the Radical-7. If necessary, remove Handheld Contacting Masimo battery. Requires service. See on page 204. Buttons Do Not Work When Pressed Internal failure.
  • Page 179 Radical-7 Chapter 7: Troubleshooting www.masimo.com Masimo...

  • Page 181: Chapter 8: Specifications

    Chapter 8: Specifications The following chapter contains specifications for the Radical-7 Handheld, compatible Docking Stations, and the Standalone system. Measurement Range Measurement Display Range (Oxygen Saturation) 0% to 100% SpMet (Methemoglobin) 0% to 99.9% SpCO 0% to 99% (Carboxyhemoglobin) SpHb (Hemoglobin) 0 g/dL to 25.0 g/dL...

  • Page 182: Accuracy (Arms)

    Radical-7 Chapter 8: Specifications Measurement Display Range RRp (Respiration Rate) 0 breaths per minute to 70 breaths per minute Accuracy (ARMS) Oxygen Saturation (SpO No Motion [1] Adults, Pediatrics, Infants (SpO from 60% to 80%) Adults, Pediatrics, Infants No Motion [2]...

  • Page 183: Resolution

    Radical-7 Chapter 8: Specifications Low Perfusion All patient populations 3 bpm Carboxyhemoglobin Level (SpCO) [1] Range of 1% to 40% Adults, Pediatrics, Infants 3% Methemoglobin Level (SpMet) [1] Range 1% to 15% All patient populations Total Hemoglobin SpHb [6] Range of 8 g/dL to 17 g/dL Adults, Pediatrics...

  • Page 184: Electrical

    Radical-7 Chapter 8: Specifications Parameter Resolution Pulse Rate 1 beats per minute Respiration Rate 1 breath per minute Electrical Standalone AC Power 100 to 240 VAC, 47 to 63 Hz requirements Power 55 VA consumption UL Listed, Metric (5x20mm), rated 250 VAC, 1 Amp,...

  • Page 185: Environmental

    Radical-7 Chapter 8: Specifications Environmental Environmental Conditions Operating Temperature 32°F to 122°F (0°C to 50°C) Transport/Storage Temperature -40°F to 158°F (-40°C to 70°C) [8] Operating Humidity 10% to 95%, non-condensing Operating Altitude 500 mbar to 1060 mbar -1000 ft to 18,000 ft...

  • Page 186: Alarms

    Radical-7 Chapter 8: Specifications Weight Handheld 1.2 lbs. (0.54 kg) Docking Station (RDS-1, RDS-2, RDS-3) 2.5 lbs. (1.14 kg) Standalone (RDS-1, RDS-2, RDS-3) 3.8 lbs. (1.73 kg) Alarms Technical Alarm Description Type 571 Hz tone, 5-pulse burst, pulse spacing: 0.250s, High Priority 0.250s, 0.500s, 0.250s, repeat time:10s...

  • Page 187: Display Indicators

    Radical-7 Chapter 8: Specifications Display Indicators Item Description Trend Memory Max of 96 hours at 2-second resolution Display Update Rate 1 second Type Backlit Active Matrix TFT LCD Pixels 480 dots x 272 dots Dot Pitch 0.25 mm Compliance EMC Compliance...
  • Page 188 Radical-7 Chapter 8: Specifications EN/ISO 80601-2-61:2011 CAN/CSA C22.2 No. 601-1 Equipment Classification per IEC 60601-1 Type of Protection Internally powered (on battery power) Degree of Protection of Defibrillation proof BF-Applied Part Electrical Shock Protection against harm from IPX1 Protection against liquid drops liquid ingress falling vertically.

  • Page 189: Output Interface

    Radical-7 Chapter 8: Specifications Wireless Radio (If Installed) Duty Cycle 6% (maximum) (Note: The software sends 120 bytes at 62.5 Hz for 7,500 bytes per second, or 60 Kbps. Worst duty cycle will be at the minimum transmission bit rate of 1.1 Mbps. Therefore, the calculated duty cycle is 0.06 Mbps / 1.1 Mbps, which results in...

  • Page 190: Serial Interface Specifications

    RS-232 protocol. The Radical-7 by default always outputs ASCII 1 text data through the serial port, unless the user selects a different output mode. 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.
  • Page 191 Radical-7 Chapter 8: Specifications Parameter Setting Parity None Bits 1 start, 1 stop Handshaking None Connector type Female DB-9 The pin-outs for the RS-232 connector are shown in the following table: Pin Signal name No Connection Receive data – RS-232 ±9 V (±5 Vmin) Transmit data –...

  • Page 192: Analog Output And Nurse Call Specifications

    Radical-7 Chapter 8: Specifications Analog Output and Nurse Call Specifications Analog Out and Nurse Call are accessible on the same female high- density DB-15 connector. Analog Output and Nurse Call interface are only available when the Handheld is attached to the Docking Station. Only use an Analog and Nurse Call cable that has a ferrite bead installed.
  • Page 193 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. For maximum www.masimo.com...

  • Page 194: Symbols

    Max voltage 100V DC or AC peak Max Current 100mA Symbols The following symbols are found on the Radical-7, Docking Station, or packaging and are defined below. Some of the interfaces and symbols are not available on all versions of the Docking Station.
  • Page 195 Radical-7 Chapter 8: Specifications Symbols Definition Symbols Definition Follow Instructions for Fragile/breakable, handle with care Fuse replacement Date of Manufacture IPX1 Protection against Analog Out interface liquid drops falling vertically Nurse Call interface Defibrillation proof type Separate collection for Authorized...

  • Page 196: 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 197 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 198 4-6 seconds, respectively. [10] Maximum sensitivity mode fixes perfusion limit to 0.02%. [11] Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and Instrument has been validated for the range of 4 to 70 breaths per minute in bench top testing. Clinical validation for up to 30 breaths per minute was also performed with the Masimo Acoustic Respiration Sensor and Instrument.

  • Page 199: Chapter 9: Service And Maintenance

    Safety checks should be performed at regular intervals or in accordance with local and governmental regulations. Warnings and Cautions on page 15. The Radical-7 is a reusable device. The device is supplied and used non- sterile. To surface clean the Radical-7 •...

  • Page 200: Battery Operation And Maintenance

    Radical-7 Docking Station may include the optional 6.5 amp-hour nickel metal hydride rechargeable battery. Before using the Radical-7 as a Handheld or as a transport monitor, the Handheld rechargeable battery and the optional Docking Station rechargeable battery must be fully charged.
  • Page 201 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 202 Before installing or removing the battery, make sure the AC power cord is removed and power to the Radical-7 is turned off. To replace the rechargeable Handheld battery Turn off the Radical-7 Handheld off and remove the patient cable connection. If docked, detach the Handheld from the Docking Station.
  • Page 203 Radical-7 Chapter 9: Service and Maintenance Battery Operation and Maintenance on page 196. Replacing the Fuses Should a power problem blow one or both of the fuses in the power entry module on the rear panel, the fuse(s) will need to be replaced.

  • Page 204: Performance Verification

    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 205 To conduct a test with the optional Masimo SET® Tester Turn off and then turn on the Radical-7. Use the Patient Cable connector on the Radical-7 to connect the Masimo SET® Tester to the Radical-7. See the directions for use that were provided with the Masimo SET®...
  • Page 206 Connect the common lead of a digital multi-meter to the pin 12 (Nurse Call Common) of the Analog Output connector on the Radical-7. Connect the positive lead of the multi-meter to pin 6 (Nurse Call - Normally Open) of the Analog Output connector and measure that the resistance is greater than 1 MW (open circuit).

  • Page 207: Repair Policy

    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. Repair Policy Masimo or an authorized service department must perform warranty repair and service.

  • Page 208: Return Procedure

    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 209 Masimo; (e) used with other products, like new sensors, reprocessed sensors, or other accessories, not intended by Masimo to be used with the Product; (f) not used or maintained as provided in the operator’s manual or as otherwise provided in its labeling;...
  • Page 210 (h) damaged by accident, abuse, misuse, liquid contact, fire, earthquake or other external cause. 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...
  • Page 211 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 Copyright Restrictions: The Software and the accompanying written materials are copyrighted.
  • Page 212 Radical-7 Chapter 9: Service and Maintenance 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.

  • Page 213: Appendix

    Generation Delay is the time from the onset of an alarm condition to the generation of its alarm signal. The graphic below is a simplified illustration of the concept of alarm response delay and does not reflect actual lengths of delays. Reference Definition Alarm Limit Displayed SpO Alarm Signal Generation www.masimo.com Masimo...

  • Page 214: Guidance And Manufacturer's Declaration- Electromagnetic Emissions

    Radical-7 Appendix Reference Definition Saturation Time The Alarm Condition Delay is graphically represented as t – t in the figure above to show the delay due to processing and averaging. The Alarm Signal Generation Delay is graphically represented as t –...
  • Page 215 Radical-7 Appendix Guidance and Manufacturer's Declarations - Electromagnetic Emissions ME Equipment uses RF energy only for its internal function. Therefore, its RF RF Emissions Group 1 emissions are very low and are not likely CISPR 11 to cause any interference in nearby electronic equipment.

  • Page 216: Manufacturer's Declaration-Electromagnetic Immunity

    Radical-7 Appendix 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 217 Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity Surge +/-1 kV Mains power quality should line(s) to be that of a typical IEC 61000-4-5 line(s) commercial or hospital environment. +/- 2 kV line(s) to earth Voltage dips, 100% Mains power quality should...
  • Page 218 Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity Power 3 A/m 3 A/m Power frequency magnetic frequency (50 / fields should be at levels 60 Hz) magnetic characteristic of typical field. location in a typical hospital environment. IEC 61000-4-8...
  • Page 219 Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity 800 MHz to 2,5 GHz 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).
  • Page 220 Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio...

  • Page 221: Recommended Separation Distances

    Radical-7 Appendix Recommended Separation Distances Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME Equipment can help prevent...
  • Page 222 Radical-7 Appendix For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 223 Accessing the Main Menu • 41, 43, 52 Battery • 43, 71, 76 Accuracy (ARMS) • 115 Battery Operation and Acoustic Waveform View • 46 Maintenance • 30, 36, 37, 76, 114, 127, 129 Acquisition System • 25 www.masimo.com Masimo...
  • Page 224 Changing Trend Settings • 86 and Cautions • 15 Chapter 1 Color Description Table • 90 Technology Overview • 17 Compliance • 36, 37, 119 Chapter 2 Compliance Warnings and Radical-7 Descriptions • 27 Cautions • 15 Chapter 3 www.masimo.com Masimo...
  • Page 225 Functional Oxygen Saturation Desat Index Settings • 102 (SpO2) • 18 Device Does Not Turn On • 113 Functionality of the Radical-7 • Device Output • 37, 71, 76, 131 Device Settings • 52, 71, 106, Device Turns On But Screen is General Description for Blank •...
  • Page 226 Radical-7 Index General Description for Oxygen Handheld Front Panel • 28, 122 Saturation (SpO2) • 18 General Description for In Vivo Adjustment Overview • Perfusion Index (PI) • 19 55, 58, 60, 66, 67 General Description for Pleth In Vivo for SpCO • 56, 66 Variability Index (PVI) •...
  • Page 227 Low Battery Message • 106 Low Perfusion • 106, 112 Navigating the Main Menu • 52 Low Perfusion Index Message • Navigating the Radical-7 • 41 Near Expiration Message • 109 Low Signal IQ Message • 107 No Adhesive Sensor Connected Low Signal Quality •...
  • Page 228 Technology® • 19 PI Delta Settings • 103 RAM Check Sensor Message • Pleth + Sig IQ + Acoustic View • 46, 47 RAM Sensor Initializing Message Powering Off the Radical-7 • 97 • 106 Power-On Self Test • 130 www.masimo.com Masimo...
  • Page 229 Radical-7 Index Recommended Separation Distances • 140 Safety Warnings and Cautions • Repair Policy • 131 9, 111 Replace Adhesive Sensor Sales & End-User License Message • 104 Agreement • 133 Replace Cable Message • 104 Screen Orientation • 71, 75 Replace Sensor Message •...
  • Page 230 Radical-7 Index Settings • 72 SpO2 Settings • 54, 56 Signal Extraction Technology SpO2 Values Do Not Correlate (SET) • 17 With Clinical Assessment or Arterial Blood Gas Signal IQ (SIQ) • 111 Measurements • 112 Signal IQ Indicators • 45, 46 SpOC Alarms •...
  • Page 231 Radical-7 Index Testing with the optional Visualization • 90 Masimo SET Tester • 130 Trend Field • 44, 53 Warnings and Cautions • 9, 21, Trends • 44, 53, 77 22, 23, 35, 99, 127 Troubleshooting Measurements Waveform and Trend Views •...
  • Page 234 LAB-10107B-0319...

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