Masimo Radius VSM Operator's Manual
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Masimo Radius VSM Operator's Manual

Masimo Radius VSM Operator's Manual

Patient-worn vital signs monitor
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Operator's Manual
Radius VSM™
Patient-Worn Vital Signs Monitor

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Summary of Contents for Masimo Radius VSM

  • Page 1 Operator's Manual Radius VSM™ Patient-Worn Vital Signs Monitor...
  • Page 3 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 Radius VSM are prerequisites for its proper use. Do not operate Radius VSM without completely reading and understanding these instructions.
  • Page 4 Radius VSM™ is a trademark of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. © 2023 Masimo Corporation www.masimo.com Masimo...

  • Page 5: Table Of Contents

    Electrocardiogram (ECG) --------------------------------------------------------------------------------------------------- 26 Temperature-------------------------------------------------------------------------------------------------------------------- 27 Chapter 2: System Components-------------------------------------------------------------------------------------------- 29 General System Description ----------------------------------------------------------------------------------------------- 29 Radius VSM Patient-Worn Vital Signs Monitor ----------------------------------------------------------------------- 29 ECG Module-------------------------------------------------------------------------------------------------------------------- 31 Noninvasive Blood Pressure Module ------------------------------------------------------------------------------------ 32 Radius VSM Charger -------------------------------------------------------------------------------------------------------- 33 Radius VSM Root Battery Charging Adapter -------------------------------------------------------------------------- 34...
  • Page 6 Chapter 11: Troubleshooting ---------------------------------------------------------------------------------------------- 105 Troubleshooting Measurements ---------------------------------------------------------------------------------------- 105 Troubleshooting Radius VSM -------------------------------------------------------------------------------------------- 108 Chapter 12: Specifications -------------------------------------------------------------------------------------------------- 111 Radius VSM Device Specifications ------------------------------------------------------------------------------------- 111 ECG Specifications --------------------------------------------------------------------------------------------------------- 117 Noninvasive Blood Pressure (NIBP) Specifications --------------------------------------------------------------- 119 Temperature Specifications ---------------------------------------------------------------------------------------------- 119...
  • Page 7 Maintenance------------------------------------------------------------------------------------------------------------------ 131 Repair Policy ----------------------------------------------------------------------------------------------------------------- 133 Return Procedure ----------------------------------------------------------------------------------------------------------- 133 Contacting Masimo --------------------------------------------------------------------------------------------------------- 134 Appendix A: Radius VSM Operation with Root --------------------------------------------------------------------- 137 Overview ---------------------------------------------------------------------------------------------------------------------- 137 Operation ---------------------------------------------------------------------------------------------------------------------- 137 Blood Pressure Measurements using Root -------------------------------------------------------------------------- 143 Appendix B: Concepts of Alarm Response Delay ------------------------------------------------------------------ 145...

  • Page 9: About This Manual

    About This Manual This manual explains how to set up and use the Radius VSM™. Important safety information relating to general use of Radius VSM 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

    PVi. Devices with Masimo technology are only indicated for use with Masimo accessories. Contraindications Radius VSM is contraindicated for patients who may have an allergic reaction to the adhesives or ECG gel. www.masimo.com Masimo...

  • Page 13: Safety Information, Warnings And Cautions

    WARNING: Do not start or operate Radius VSM unless the setup was verified to be correct. Improper set-up of this device may result in degraded performance and/or patient injury. WARNING: Do not place the Radius VSM or accessories in any position that might cause it to fall on the patient.
  • Page 14 Radius VSM Safety Information, Warnings and Cautions WARNING: Radius VSM may be used during defibrillation. However, to reduce the risk of electric shock, the operator should not touch the Radius VSM during defibrillation. WARNING: To protect against injury, follow the directions below: •...

  • Page 15: Performance Warnings And Cautions

    Safety Information, Warnings and Cautions Performance Warnings and Cautions WARNING: Radius VSM should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: Radius VSM has not been validated for use in pediatric population.
  • Page 16 Radius VSM Safety Information, Warnings and Cautions WARNING: SpO is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). WARNING: Optical, pleth-based measurements (e.g. SpO , PVi and RRp) can be affected by the following: •...
  • Page 17 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Radius VSM, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 18 CAUTION: Do not place the Radius VSM near electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Radius VSM promptly after a Low Battery alarm may result in the device shutting down. CAUTION: The Radius VSM is has the ability to operate across the facility's network. Unanticipated failure or alteration of network components (including but not limited to: disconnection or malfunctioning of a networking device/switch/router/ethernet cable) may result in loss of supplemental notifications.
  • Page 19 Note: Radius VSM’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Radius VSM's primary alarms. Note: Always charge Radius VSM when it is not in use to ensure that the Radius VSM battery remains fully charged.
  • Page 20 CAUTION: If the blood pressure cuff is on the same limb as the Radius VSM monitoring equipment, avoid securing the Radius VSM too tight as it may cause constriction of the blood volume used in determining your blood pressure.

  • Page 21: Cleaning And Service Warnings And Cautions

    CAUTION: To avoid permanent damage to the Radius VSM, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended.
  • Page 22 • Consult the dealer or an experienced radio/TV technician for help. Note: When using Radius VSM consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices. Note: In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment.

  • Page 23: Chapter 1: Technology Overview

    ® because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET ® signal processing algorithm, Discrete Saturation Transform...
  • Page 24 SpO pulse rate. Functional Oxygen Saturation (SpO2) The Radius VSM 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 Radius VSM Chapter 1: Technology Overview 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. Pi thus represents a noninvasive measure of peripheral perfusion that can be continuously and noninvasively obtained from a pulse oximeter.
  • Page 26 Radius VSM 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: Rainbow Acoustic Monitoring® (Ram®)

    Radius VSM Chapter 1: Technology Overview The height of the vertical line of the SpO SIQ provides an assessment of the confidence in the measurement displayed. A high vertical bar indicates higher confidence in the measurement. A small vertical bar indicates lower confidence in the displayed measurement. When the Signal IQ is very low, this suggests that the accuracy of the displayed measurement may be compromised.

  • Page 28: Electrocardiogram (Ecg)

    The Masimo Radius VSM ECG System acquires electrical signals from the patient through multiple electrodes placed on the patient’s skin. The Radius VSM will process these electrical signals to reproduce the ECG waveform and to provide an estimate of the patient’s heart rate and/or respiration rate.

  • Page 29: Temperature

    Temperature The Radius VSM provides a direct mode surface temperature of the skin where the Radius VSM Multi- Functional Reusable Pod is applied. The displayed temperature may require time to equilibrate after initial application (up to 10 minutes).

  • Page 31: Chapter 2: System Components

    Chapter 2: System Components This chapter contains the description of the Radius VSM physical features. General System Description The Radius VSM system includes these components: • Radius VSM Patient-Worn Vital Signs Monitor • Root Battery Charging Adapter or Radius VSM Charger •...
  • Page 32 Armband or charger. Radius VSM Armband The cradle (1) is part of the Armband (2). The Radius VSM locks in the cradle. The armband is a disposable accessory. See Securing Radius VSM to the Patient and attaching a Sensor on page 36.

  • Page 33: Ecg Module

    ECG Module includes a temperature sensor and an integrated patient orientation and activity sensor. 2. ECG Module Connector Connects to the NIBP Module or the Radius VSM. ECG Electrodes and Temperature Sensor 1. ECG Main Electrode The ECG Electrodes and Main Connector are the disposable parts that attach to the patient's chest and the ECG Module.

  • Page 34: Noninvasive Blood Pressure Module

    Radius VSM Chapter 2: System Components Noninvasive Blood Pressure Module The NIBP Module is a reusable item of the Radius VSM system. Front and Top Views 1. Power Light On when connected to Radius VSM and powered on. 2. Connector The ECG Module connects here.

  • Page 35: Radius Vsm Charger

    Radius VSM Chapter 2: System Components Radius VSM Charger 1. Charging Connector Pins Connections to charge the Radius VSM battery. See Battery Charging on page 2. Power Entry Module Connection for the AC power cord. www.masimo.com Masimo...

  • Page 36: Radius Vsm Root Battery Charging Adapter

    Radius VSM Chapter 2: System Components Radius VSM Root Battery Charging Adapter The Radius VSM Battery Charging Adapter fits into the docking station on Root. 1. Radius VSM Pocket Store the Radius VSM when not used or when charging. 2. Charging Connector Pins Connections to charge the Radius VSM battery.

  • Page 37: Chapter 3: Basic Setup And Use

    • To charge using Root, attach the Battery Charging Adapter to Root. See Radius VSM Root Battery Charging Adapter on page 33. • For the Radius VSM Charger, connect the charger power cord to a working AC outlet. See Radius VSM Charger on page 33.

  • Page 38: Radius Vsm System Setup

    Securing Radius VSM to the Patient and attaching a Sensor Charge the Radius VSM before placing on the patient. See Initial Battery Charging. Note: Attach the Radius VSM to the non-dominant arm. However, the Radius VSM can be attached to either arm.
  • Page 39 CAUTION: Only the tacky side of the armband fabric should make contact with the patient when properly applied. Note: The cradle and Radius VSM should be attached so the Masimo logo is at the top. Pull the armband through the slot in the cradle (3).
  • Page 40 Disconnect the NIBP or ECG Module connector. Remove the armband with the Radius VSM from the patient’s arm. Press the release buttons on the Radius VSM and remove from the cradle. Disinfect and clean the Radius VSM. See Cleaning on page 129.
  • Page 41 Attaching an Acoustic Sensor Note: The acoustic sensor should be attached to the same side of the body as the Radius VSM. Note: Radius VSM only displays the RRa parameter when the acoustic sensor is connected. Note: The acoustic sensor is single- patient-use.
  • Page 42 2. Place Cuff on Measurement Site Note: The cuff can be used on either arm, but should be on the same arm as Radius VSM. Locate the brachial artery in the middle of the inner arm. Wrap the cuff around the arm, making sure the Artery-mark is aligned over the located brachial artery (1) as shown.
  • Page 43 Position the Module on the cuff with the cable pointing upwards as shown. Press the module on the cuff nibs until fully seated. 4. Connect the NIBP Module to the Radius VSM Connect the NIBP Module green cable connector to the green port on Radius VSM.
  • Page 44 ECG Module to the NIBP Module. The ECG Module can also be connected directly to the Radius VSM (the NIBP Module cannot be connected to Radius VSM). Note: ECG Module includes a temperature sensor and an integrated patient orientation and activity sensor.
  • Page 45 WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Note: The ECG Electrodes should be oriented to the same side of the body as the Radius VSM. Note: The ECG Electrodes are single-patient-use.
  • Page 46 See Front and Top Views on page 32. Removing the ECG Module and Electrodes Disconnect the ECG Module from the Radius VSM NIBP Module or Radius VSM. Release the tab and remove the ECG Module from the ECG Electrodes. Remove the electrodes from the patient.

  • Page 47: Powering Radius Vsm On And Off

    The Radius VSM has the ability to be located by sounding a tone. With Radius VSM connected to Root, go to the About screen on Root and select Locator. See About Root on page 142. If Radius VSM is within range of Root and connected, it will sound a tone.

  • Page 49: Chapter 4: Operation

    Chapter 4: Operation The information in this chapter assumes that Radius VSM is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Radius VSM without completely reading and understanding these instructions.
  • Page 50 Touch and quickly swipe (left, right, up or Flick down), and release. Below is a list of all the different types of controls available on Radius VSM and the various ways to interact with each type of control. Control Applicable Actions...
  • Page 51 Radius VSM Chapter 4: Operation Control Applicable Actions Description Button Touch • Performs action (as defined by the button description) Icon Menu Touch tile • Opens menu specified by tile Swipe left or right (anywhere) • Scrolls icons left or right Touch bottom indicator icon •...

  • Page 52: About The Main (Summary) Screen

    Chapter 4: Operation About the Main (Summary) Screen The Summary Screen displays information and parameters from the Radius VSM system. The information and parameters displayed on the Summary Screen are a direct result of connected accessories. The Summary Screen can be composed of the following items.
  • Page 53 When Radius VSM is On, the Battery Charge Indicator displays the remaining battery charge as follows: Note: The System Status Light also indicates battery charging status. See About the System Status Light on page 54. Note: When Radius VSM goes into low battery mode, there is approximately 15 minutes of battery life left. Icon Status The Radius VSM Wearable Monitor is running on battery power.
  • Page 54 Status Bar on page 50. Icon Description A gray icon indicates Radius VSM wireless radio is on, but it is not connected to a wireless network. A blue icon indicates Radius VSM is connected to a wireless network, but not communicating with Patient SafetyNet.
  • Page 55 IQ indicators, and acoustic waveform displays. Screen Lock Feature To prevent unintended changes to the settings of Radius VSM the device has a feature that can be enabled to lock the screen after 60 seconds with no interaction. To enable or disable this feature, see Access Control on page 60.

  • Page 56: About The System Status Light

    The System Status Light is part of the On/Off button and located on the top of the device. See Front and Top Views on page 29. The System Status Light provides visual indications of battery charging progress and Radius VSM operation. The light illuminates different colors depending on the state of the device. Light Status...
  • Page 57 Trends Settings* See Trends on page 61. * When Radius VSM is connected to Root, this setting no longer displays on Radius VSM and displays in the Root Main Menu. See Accessing Root Main Menu Options on page 139. Navigating the Main Menu Once the Main Menu screen is displayed, users can access additional screens, information and settings.

  • Page 58: Sounds

    Radius VSM Chapter 4: Operation Sounds Use the Sounds screen to control the volume of sounds and duration of audio pause on Radius VSM. The Sound icon appears on the status bar. See About the Status Bar on page 50. Option...
  • Page 59 * This icon is neither available nor displayed in the Device Settings menu when Home Mode Menu Enabled is ON. See Access Control on page 60. ** When Radius VSM is connected to Root, this setting does not display. Localization Use the Localization screen to configure settings related to local time, language and geography.
  • Page 60 Use the Wi-Fi screen to enable or disable Wi-Fi connectivity. When Radius VSM is connected to a Wi-Fi network, the Wi-Fi icon on the Status Bar indicates the status of the connection. See Wi-Fi Connection Status on page 52.
  • Page 61 Radius VSM Battery Use the Battery screen to view the specific percentage of charge remaining in Radius VSM's battery. The Battery icon appears in the Status Bar. See About the Status Bar on page 50.

  • Page 62: About

    Press Restore. Factory Defaults Options are restored to factory values. About Use the About screen to view the serial number as well as Radius VSM software and hardware version information. These details may be helpful during troubleshooting. Option * Description Serial Number Displays the serial number for the device.

  • Page 63: Trends

    Radius VSM Chapter 4: Operation Option * Description NIBP Tech Board Displays the version number for the NIBP Module. * These fields are read-only and cannot be configured by the user. Trends Trend settings allow the user to configure the Y-axis maximum and Y-axis minimum for each parameter.

  • Page 64: About Parameter Information

    Radius VSM 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 An About screen appears for the selected parameter and displays information about the parameter.

  • Page 65: Chapter 5: Pulse Ox

    • Additional Settings for Pulse Ox on page 70 * When connected with Root, this setting displays on Root and not on Radius VSM. In the Parameter Settings screen, swipe left or right to access and select the desired parameter icon.
  • Page 66 • About Parameter Information on page 61 • Trend Settings on page 143 * * This setting is only available and displayed on Root when Radius VSM is connected to Root. SpO2 Alarms From the Alarms screen, change any of the following options:...
  • Page 67 • About Parameter Information on page 61 • Trend Settings on page 143 * * This setting is only available and displayed on Root when Radius VSM is connected to Root. PR Alarms From the PR Alarms screen, change any of the following options:...
  • Page 68 • About Parameter Information on page 61 • Trend Settings on page 143 * * This setting is only available and displayed on Root when Radius VSM is connected to Root. Pi Alarms From the Alarms screen, change any of the following options:...
  • Page 69 Time calculates the average of all data points. RR Settings Radius VSM can determine Respiration Rate (RR) either by the acoustic signal (RRa) or the plethysmographic waveform (RRp). For more information, see: • RRa Settings on page 67 • RRp Settings on page 69 RRa Settings When using an acoustic sensor, Respiration Rate (RR) is determined by the acoustic (RRa) signal.
  • Page 70 • About Parameter Information on page 61 • Trend Settings on page 143 * * This setting is only available and displayed on Root when Radius VSM is connected to Root. RRa Alarms From the Alarms screen, change any of the following options:...
  • Page 71 • Additional Settings for RRp on page 70 • About Parameter Information on page 61 • Trend Settings on page 143 * * This setting is only available and displayed on Root when Radius VSM is connected to Root. www.masimo.com Masimo...
  • Page 72 Radius VSM Chapter 5: Pulse OX RRp Alarms From the Alarms screen, change any of the following options: Options Description Alarm Factory User Configurable Settings Priority Default Settings High Limit High Limit is the upper threshold High 30 breaths 6 to 69 breaths per minute in that triggers an alarm.
  • Page 73 See SpO2 Settings on page 63. Sensitivity Modes Overview Three sensitivity levels enable a clinician to tailor the response of Radius VSM to the needs of the particular patient situation. Sensitivity Modes are accessed through the Action Menu. See Action Menu.

  • Page 75: Chapter 6: Electrocardiogram (Ecg)

    ECG waveforms and an estimate of the patient’s heart rate. The counting of Premature Ventricular Contractions (PVCs) per minute is also provided. When Radius VSM is connected to a Masimo device, in addition to the ECG display on Radius VSM, ECG information also displays on the Masimo device screen.
  • Page 76 Radius VSM Chapter 6: Electrocardiogram (ECG) The waveform displays in landscape on the Radius VSM screen. The parameters do not display, only the waveform. Note: The landscape display reverts back to the ECG Screen automatically after 20 seconds. To manually exit the landscape...

  • Page 77: Ecg Settings

    • Arrhythmia Settings on page 77. • Additional Settings for ECG on page 78. * This setting is only available and displayed on Root when Radius VSM is connected to Root. ECG Parameter Settings In the Parameter Settings screen, swipe left or right to access the desired parameter.
  • Page 78 • About Parameter Information on page 61 • Trend Settings on page 143 * * This setting is only available and displayed on Root when Radius VSM is connected to Root. ECG Waveform Settings From the Waveform Settings screen, change any of the following options:...
  • Page 79 Analysis Settings The Analysis Settings are displayed and accessed on Root when Radius VSM is connected to Root. These settings are the same as listed under Arrhythmia Settings when Radius VSM is NOT connected to Root. From the Analysis Settings screen, change any of the following options:...
  • Page 80 Radius VSM Chapter 6: Electrocardiogram (ECG) Option Description Factory User Configurable Default Options Settings Primary Select the primary lead I, II, III, aVR, aVL, or Analysis Lead Secondary Select the secondary lead Off, or I, II, III, aVR, Analysis aVL, aVF...
  • Page 81 Electrode Electrode Electrode System on the Body * Identifier Color Code Identifier Color Code White Right Arm Limb Yellow Black Left Arm Green Left Leg * See Radius VSM System Setup on page 36 for ECG Electrode application. www.masimo.com Masimo...

  • Page 83: Chapter 7: Temperature

    Temperature measurements are provided to the Radius VSM from a temperature sensor built into the ECG Module. The temperature sensor is designed to continuously provide skin temperatures. When Radius VSM is connected to a compatible Masimo device, temperature data also displays on the Masimo device screen.
  • Page 84 Radius VSM Chapter 7: Temperature Temperature Alarms From the Alarms screen, change any of the following options: Options Description Alarm Factory User Configurable Priority Default Settings Settings High Limit High Limit is the upper Medium 93.4 °F to 103.9 °F, in threshold that triggers an increments of 0.1, or Off...

  • Page 85: Chapter 8: Noninvasive Blood Pressure (Nibp)

    When Radius VSM is connected to a Masimo device, in addition to the NIBP display on Radius VSM, NIBP information also displays on the Masimo device screen.

  • Page 86: Noninvasive Blood Pressure (Nibp) Settings

    • Calibration on page 86 ** * This setting displays only when scheduled NIBP measurement has been enabled. ** This setting is NOT available on Root when Radius VSM is connected to Root. Parameter Settings for Noninvasive Blood Pressure (NIBP) In the NIBP Settings screen, swipe left or right to access the desired parameter.
  • Page 87 Radius VSM Chapter 8: Noninvasive Blood Pressure (NIBP) SYS/DIA Alarms From the Systolic/Diastolic Settings screen, touch Alarms, and then change any of the following options: Alarm Factory Default User Configurable Options Description Priority Settings Settings 60 to 229 in steps of 1,...
  • Page 88 Set the interval measurement mode. Manual Manual or Schedule Allows Root to automatically restart the NIBP Auto schedule on a newly connected Radius VSM if Off ot On Restart an NIBP schedule was previously active, e.g. swapping Radius VSM during a shift change.

  • Page 89: Blood Pressure Measurements

    Radius VSM Chapter 8: Noninvasive Blood Pressure (NIBP) Blood Pressure Measurements To select the proper cuff and attach to the measurement site, see Attaching the Noninvasive Blood Pressure Cuff and Module to the Patient on page 39. Spot Check NIBP Measurement Properly place the blood pressure cuff on patient.
  • Page 90 Radius VSM Chapter 8: Noninvasive Blood Pressure (NIBP) Schedule NIBP Measurement Schedule measurement mode takes blood pressure measurements once every defined interval for the defined duration. A patient profile can have up to five (5) schedules. The schedules run consecutively, when one schedule ends the next one begins automatically.
  • Page 91 Chapter 8: Noninvasive Blood Pressure (NIBP) Note: Touching the Stop button only stops the current measurement, the next scheduled measurement will still be performed by Radius VSM. To stop the remaining scheduled measurements, select Stop Schedule from the Intervals settings screen.

  • Page 93: Chapter 9: Position Monitoring

    The ECG Module also includes a noninvasive position and activity sensor designed to continuously monitor patient movement and activity, including patient falls. When Radius VSM is connected to a compatible Masimo device, position and activity data is also displayed on the Masimo device screen...

  • Page 94: Position Monitoring Settings

    Radius VSM Chapter 9: Position Monitoring Position Monitoring Settings Note: The Position Settings display on devices ONLY when an ECG Sensor is connected to Radius VSM. From the Position Settings screen, access the following screens: • Position Monitoring Alarms on page 92 •...

  • Page 95: Chapter 10: Alarms And Messages

    There is currently an active alarm that has been silenced. Alarms Interface Alarms have different priority levels and come from different sources. Audible Alarms The following table describes audible alarm behaviors. Priority Alarm Sound High 10-pulse burst Medium 3-pulse burst www.masimo.com Masimo...
  • Page 96 High Priority Alarm The example shown here is a SpO Low alarm for Pulse Ox. The border of the entire Radius VSM display is illuminated, and the explanation of the alarm is shown in the Status Bar (SpO Low) with the effected system (Pulse Ox).
  • Page 97 (Pulse Ox). Multiple Alarm Notifications Multiple alarms may occur at one time on Radius VSM. When one or more systems attached to Radius VSM have alarms present, the user is notified the following ways: Alarm Silence Icon: The Alarm Silence icon displays the number of active alarms.
  • Page 98 Root can be temporarily silenced by touching the Alarm Silence icon on the Root or the Radius VSM. Visual alarms will continue to be displayed on Radius VSM until the alarm condition has been addressed or acknowledged for latched alarms. For alarm management on Root, see Operator’s Manual for Root.
  • Page 99 Audio Pause is activated, and there are 15 seconds left until Audio Pause is inactive again (alarms audible again). To configure Audio Pause, see Sounds on page 56. Note: When Audio Pause is activated, powering off and then powering on Radius VSM will return Audio Pause to its default inactive state. 3D Alarms...
  • Page 100 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 Radius VSM 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 98.

  • Page 101: Radius Vsm Messages

    Charge battery by docking into battery low. charger. Pulse Ox Messages The following section lists common messages, their potential causes, and next steps related to Pulse Ox operation of the Radius VSM System. Message Potential Causes Next Steps (Pulse CO-Ox) The patient cable is non-functional or the Replace the patient cable.
  • Page 102 Disconnect and reconnect the sensor. If the LED fails to operate, replace the sensor. (Pulse CO-Ox) • Not a proper Masimo sensor. • Replace with a proper Masimo Incompatible Sensor sensor. • Sensor is attached to a device without an appropriate parameter installed.
  • Page 103 Radius VSM Chapter 10: Alarms and Messages Message Potential Causes Next Steps (Pulse CO-Ox) • Not a proper Masimo sensor. • Replace with a proper Masimo Incompatible sensor. • Sensor is attached to a device without Adhesive Sensor an appropriate parameter installed.
  • Page 104 Check patient's vital condition. as parameter value - Invalid parameter alarm) Electrocardiogram Messages The following section lists common messages, their potential causes, and next steps related to ECG operation of the Radius VSM System. Alarm Description Alarm Next Step Message...
  • Page 105 Support. See Chapter 13: Check NIBP (Module Device requires service High Error) Service and Maintenance on page 129. Temperature Messages The following section lists common messages, their potential causes, and next steps related to Temperature operation of the Radius VSM System. www.masimo.com Masimo...
  • Page 106 Medium Replace the ECG Sensor sensor. Position Monitoring Messages The following section lists common messages, their potential causes, and next steps related to Position Monitoring operation of the Radius VSM System. Message Potential Causes Alarm Next Steps Priority Patient has overstayed in a given Physically check patient’s condition and...

  • Page 107: Chapter 11: Troubleshooting

    • Shield the sensor from excessive or strobing frequency-induced light. noise. • Minimize or eliminate motion at the monitoring site. • Connect AC power supply. • Verify and set 50 or 60Hz menu setting. See Localization on page 57. www.masimo.com Masimo...
  • Page 108 Radius VSM Chapter 11: Troubleshooting Symptom Potential Causes Next Steps • Parameter may not • Allow time for parameter reading to stabilize. Parameter readings have stabilized. displayed as dashes. • Verify sensor type and size and re-apply • Device may not be sensor.
  • Page 109 Radius VSM Chapter 11: Troubleshooting Troubleshooting ECG Measurements Symptom Potential Causes Next Steps • Improper electrode or • Allow time for parameter reading to stabilize. Difficulty obtaining a electrodes application. reading • Check for electrode gel dry out. • Poor electrode contact.

  • Page 110: Troubleshooting Radius Vsm

    ECG Module and Electrodes to the Patient on page 42 for electrode placement. Troubleshooting Radius VSM The following section lists possible Radius VSM symptoms, potential causes, and next steps. For more information, see Chapter 10: Alarms and Messages on page 93. Symptom...
  • Page 111 Refer to sensor Directions For Use. • Sensor expired. • Replace sensor. • Internal failure. • Turn Radius VSM Off and On. • Contact Masimo service. See Contacting Masimo on page 134. • Connection between the • Remove and reconnect the ECG...
  • Page 112 • Replace electrodes. makes a poor connection. • Check ECG module cable • Internal failure. connection. • Turn Radius VSM Off and On. • Contact Masimo service. See Contacting Masimo on page 134. • Internal failure. • Turn Radius VSM Off and On.

  • Page 113: Chapter 12: Specifications

    Chapter 12: Specifications Radius VSM Device Specifications Pulse Oximetry Specifications Display Range and Display Resolution Measurement Display Range Resolution (Functional Oxygen Saturation) 0% to 100% PR (Pulse Rate) 25 bpm to 240 bpm 1 bpm Pi (Perfusion Index) 0.0 to 0.99 0.01...
  • Page 114 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 Radius VSM. SpO2 Performance Specifications Accuracy testing for SpO was performed on healthy adult subjects.
  • Page 115 Radius VSM Chapter 12: Specifications Upper and Lower Limits of Agreement (LoA)* Upper 95% LoA 2.27% Lower 95% LoA -2.29% * See Bland and Altman. Agreement between methods of measurement with multiple observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582.
  • Page 116 Radius VSM Chapter 12: Specifications RRp Performance Specifications The below Bland Altman plots represent the correlation of RRp and the reference respiration rate in healthy adult subjects with upper 95% and lower 95% limits of agreement. Figure 2: Subject by Subject Bland-Altman plot of RRp with respect to RRref_c The below Bland Altman plots represent the correlation of RRp and the reference respiration rate in hospitalized adult subjects with upper 95% and lower 95% limits of agreement.
  • Page 117 * After 12 months storage duration, battery shall go through 1 full discharge and 1 full charge. After cycling, set battery to SOC 35+/-5%. Physical Characteristics Radius VSM Physical Characteristics Dimensions 10.9 cm x 5.8 cm x 2.1 cm (4.28” x 2.28” x 0.83”) Weight 122 g (0.27 lbs.)
  • Page 118 Radius VSM Chapter 12: Specifications Alarms Alarm Alarm Status Audio Alarm Description Priority Color High Priority Flashing red 571 Hz tone, 10-pulse burst, pulse spacing: 0.25s, 0.25s, 0.50s, 0.25s, repeat time:10s Medium Flashing yellow 550 Hz tone, 3-pulse burst, pulse spacing: 0.375s, 0.375s, repeat...

  • Page 119: Ecg Specifications

    Radius VSM Chapter 12: Specifications Communication (Bluetooth) Classification of Output Power Rating Conducted Output Power Type Fixed at the Factory Bluetooth; DH5, 2DH5, 3DH5 Modulation Types Bluetooth LE; GFSK Modulation Signals Analog and Digital Available Data Rates Bluetooth 1, 2, 3 Mbps...
  • Page 120 Radius VSM Chapter 12: Specifications Respiration Rate (RR) Range of 0, 4 rpm to 120 rpm ≤ 1 rpm accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- A of the reference measurements in a controlled study.

  • Page 121: Noninvasive Blood Pressure (Nibp) Specifications

    Radius VSM Chapter 12: Specifications Noninvasive Blood Pressure (NIBP) Specifications Display Range Measurement Patient Population Display Range Systolic Adult 60 to 230 mmHg Diastolic Adult 40 to 130 mmHg Pulse Rate (PR) Adult 30 to 240 bpm Accuracy Pressure Transducer Between 0 mmHg and 300 mmHg ±3 mmHg...

  • Page 122: Position Monitoring Specifications

    Patient Recline Angle [12] -180° to 180° Time in Current Position 0:00 to 99:59 Radius VSM Charger Specifications Physical Characteristics Radius VSM Battery Charger Physical Characteristics Dimensions 22.9 cm x 9.4 cm x 5.4 cm (9.0” x 3.7” x 2.1”) Weight 203 g (0.45 lbs.)

  • Page 123: Compliance

    Radius VSM Chapter 12: Specifications Environmental Conditions Operating Humidity 10% to 95%, non-condensing Storage/Transport Humidity 10% to 95%, non-condensing 540 mbar to 1060 mbar Operating Atmospheric Pressure (540 hPa to 1060 hPa) Compliance EMC Compliance IEC 60601-1-2:2014, Class B Safety Standards Compliance...

  • Page 124: Guidance And Manufacturer's Declarations - Electromagnetic Compatibility

    Radius VSM Chapter 12: Specifications Equipment Classification per IEC 60601-1 Radius VSM Patient-Worn Vital Signs IP24, Protected from objects greater than 12 millimeters and Monitor, ECG Module water spray from any direction. Mode of Operation Continuous Guidance and Manufacturer's Declarations - Electromagnetic...

  • Page 125: Test Specifications For Enclosure Port Immunity To Rf Wireless Communication Equipment

    10 V/m 10 V/m Portable and mobile RF communications equipment should IEC 61000-4-3 be used no closer to any part of the Radius VSM, including 80 MHz cables, than the recommendation separation distance to 2.7 calculated from the equation applicable to the frequency of the transmitter.

  • Page 126: Recommended Separation Distances

    (c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Radius VSM. Rated maximum output power of Separation distance according to frequency of transmitter transmitter 80 MHz to 2.7 GHz...

  • Page 127: Symbols

    Radius VSM Chapter 12: Specifications Symbols The following symbols may appear on the product or product labeling: Symbol Description Symbol Description Follow instructions for use Consult instructions for use Separate collection for Mark of conformity to European electrical and electronic...

  • Page 128: Citations

    70%-100% SpO against a laboratory CO-Oximeter and ECG monitor. [4] The Radius VSM has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2™* 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 129 Radius VSM Chapter 12: Specifications validation for up to 61 breaths per minute was also performed with the Masimo Acoustic Respiration Sensor and Instrument. [7] RRp performance has been clinically validated on 28 healthy, adult volunteers, 59 hospitalized adult patients. The clinical testing included non-randomized studies comparing RRp measurements against manual, clinician-scored capnograms.

  • Page 131: Chapter 13: Service And Maintenance

    Chapter 13: Service and Maintenance Cleaning The Radius VSM, NIBP Module and ECG Module are reusable devices. The devices are supplied and used non-sterile. The devices should be cleaned before and after it has been applied to a patient and/or in accordance with local and governmental regulations to minimize the risk of cross-contamination.
  • Page 132 Radius VSM Chapter 13: Service and Maintenance To conduct Safety Checks follow the procedure outlined in this chapter. If Radius VSM fails any of the described tests, discontinue its use and refer to Chapter 11: Troubleshooting on page 105. Before performing the following tests, do the following: •...

  • Page 133: Maintenance

    CAUTION: The battery is not user replaceable, contact Masimo Service if the battery needs to be replaced. Note: Always store the Radius VSM on the charger. Do not place it on a conductive surface where the connection pins may be shorted.
  • Page 134 Chapter 13: Service and Maintenance Equipment • Calibrated Manometer* • Pneumatic "T" Adapters • Masimo NIBP Module adapter fixture • 500mL bottle • Hand Bulb • Connection Tubing *Verify the manometer has been calibrated within the last 12 months. Calibration accuracy shall be within ±0.02% to ±0.25% FS (Full Scale) and a measurement uncertainty of ±1 LSD (Least Significant Digit).

  • Page 135: Repair Policy

    • Warranty information, a copy of the invoice or other applicable documentation must be included. • Purchase order number to cover repair if the Radius VSM is not under warranty, or for tracking purposes if it is.

  • Page 136: Contacting Masimo

    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 137 Product. If you do not agree to the terms of this agreement, promptly return the entire Product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund. Restrictions Copyright Restrictions: The Software and the accompanying written materials are copyrighted.

  • Page 139: Appendix A: Radius Vsm Operation With Root

    The following information outlines Radius VSM operation when connected to Root. Additional data, displays and settings may be available on Root that are not available directly on the Radius VSM device. This section discusses this Root specific information and is intended to be used with the Operator's Manual, Root®...
  • Page 140 Radius VSM Appendix A: Radius VSM Operation with Root Ref. Feature Description Displays the pulse oximeter parameter information from Radius VSM. See Pulse Ox Window Chapter 4: Operation on page 47. Displays the ECG information from Radius VSM. See Chapter 6: ECG Window Electrocardiogram (ECG) on page 73.
  • Page 141 To access the Main Menu options of the Root, press/select the Main Menu icon at the bottom right corner of the Root touchscreen. The Radius VSM settings on the Root are similar to the settings on Radius VSM. For complete Root operating instructions, refer to the Operator's Manual, Root® or Operator's Manual, Root® with noninvasive blood pressure and temperature.
  • Page 142 See Trend Settings on page 143. Root Layout with Radius VSM When the Radius VSM is connected to Root, the user will have the option to select from several pre- configured layouts. Image below shows possible layout options available on Root with the Radius VSM connected.
  • Page 143 Note: This setting displays on Root with Radius VSM connected. Waveform Settings are located within the rainbow Settings for the Pulse OX feature of Radius VSM when connected to Root. Use the Waveform Settings to set the waveforms displayed in the Pulse OX window on the Root Main Screen.
  • Page 144 Use the About screen on Root to view the serial number as well as software and hardware version information about Radius VSM and accessories. These details may be helpful during troubleshooting. The below fields are read-only and cannot be configured by the user, unless otherwise noted.

  • Page 145: Blood Pressure Measurements Using Root

    1 to 70 in steps of 1 Blood Pressure Measurements using Root When Radius VSM is connected to Root, blood pressure measurements can be performed directly from Root. Operation is similar to Radius VSM. See Blood Pressure Measurements on page 87.

  • Page 147: Appendix B: 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 149: Index

    Brightness • 57, 59 About This Manual • 7 Access Control • 53, 56, 57, 60 Calibration • 84, 86 Accessing Radius VSM Main Menu Options • 47, 50, Chapter 1 Accessing Root Main Menu Options • 55, 139 Technology Overview • 21 Accuracy •...
  • Page 150 Electromagnetic Compatibility • 122 Compliance Warnings and Cautions • 19 Concepts of Alarm Response Delay • 145 Connecting Radius VSM with Root • 45, 59 HR Settings (ECG) • 75 Contacting Masimo • 54, 108, 109, 110, 133, 134 Contraindications • 9 Intended Use/Indication for Use •...
  • Page 151 Position Monitoring Settings • 54, 91, 92, 140 RRa Settings • 67 Position Monitoring Specifications • 120 RRp Alarms • 69, 70 Powering Radius VSM ON and OFF • 45, 130 RRp Performance Specifications • 114 Power-On Self-Test • 130 RRp Settings • 67, 69 PR Alarms •...
  • Page 152 Trend View Controls • 138, 139 Trends • 55, 61, 81, 142 Troubleshooting ECG Measurements • 107 Troubleshooting Measurements • 105 Troubleshooting Radius VSM • 108 Using the Touchscreen and Home Button • 47 Using the Touchscreen Interface • 47 Waveform Mode • 141 Waveform Settings •...
  • Page 154 304511/LAB-12000A-0823...

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