Masimo Rad-97 Operator's Manual
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Masimo Rad-97 Operator's Manual

Pulse co-oximeter
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Rad-97™ Pulse CO-Oximeter

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Summary of Contents for Masimo Rad-97

  • Page 1 Operator's Manual ® Rad-97™ Pulse CO-Oximeter...
  • Page 3 These operating instructions provide the necessary information for proper operation of all models of the Rad-97. 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 Rad-97 are prerequisites for its proper use.
  • Page 4 The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium. All other registered trademarks and trademarks are property of their respective owners. © 2017 Masimo Corporation www.masimo.com Masimo...

  • Page 5: Table Of Contents

    Chapter 3: Setting Up------------------------------------------------------------------------------------ 39 Unpacking and Inspection -------------------------------------------------------------------------- 39 Preparation for Use ----------------------------------------------------------------------------------- 39 Guidelines for Setting Up ---------------------------------------------------------------------------- 39 Powering the Rad-97 ON and OFF ------------------------------------------------------------------ 40 Initial Battery Charging ------------------------------------------------------------------------------- 41 Nurse Call Connection -------------------------------------------------------------------------------- 41 Attach NIBP Cuff --------------------------------------------------------------------------------------- 42...
  • Page 6 Not Admitted ------------------------------------------------------------------------------------------ 117 Admitting a Patient ---------------------------------------------------------------------------------- 118 Discharging a Patient ------------------------------------------------------------------------------- 120 Chapter 8: Third-Party Devices ------------------------------------------------------------------------- 121 Connect Device to Rad-97 --------------------------------------------------------------------------- 121 Chapter 9: Alarms and Messages --------------------------------------------------------------------- 123 Alarm Interface --------------------------------------------------------------------------------------- 123 About Alarms ------------------------------------------------------------------------------------------ 124...
  • Page 7 Rad-97 Contents Chapter 10: Troubleshooting -------------------------------------------------------------------------- 137 Troubleshooting Measurements ------------------------------------------------------------------- 137 Troubleshooting Rad-97 ---------------------------------------------------------------------------- 140 Chapter 11: Specifications ------------------------------------------------------------------------------ 145 Pulse CO-Oximetry Specifications ----------------------------------------------------------------- 145 Noninvasive Blood Pressure (NIBP) Specifications -------------------------------------------- 150 Electrical ----------------------------------------------------------------------------------------------- 151 Environmental ---------------------------------------------------------------------------------------- 152 Physical Characteristics ----------------------------------------------------------------------------- 152...

  • Page 9: About This Manual

    This manual explains how to set up and use Rad-97™ Pulse CO-Oximeter®. Important safety information relating to general use of Rad-97 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

    Ability to display data on a secondary display. For all prescribing information and instructions for use of the compatible medical devices connected to Rad-97, see the Operator's Manual or Instructions for Use for the specific medical device. * Currently not available in the U.S.A. and territories relying on FDA market clearance.

  • Page 12: Indications For Use

    ) and pulse rate (PR) to multi-parameter devices for the display on those devices. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is www.masimo.com...

  • Page 13: Contraindications

    1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older Contraindications The Rad-97 is not intended for use as an apnea monitor. www.masimo.com Masimo...

  • Page 15: Safety Information, Warnings And Cautions

    Safety Warnings and Cautions WARNING: Do not use Rad-97 if it appears or is suspected to be damaged. Damage to the device can result in exposed electrical circuits that may cause patient harm. WARNING: Do not adjust, repair, open, disassemble, or modify the Rad-97. Damage to the device may result in degraded performance and/or patient injury.
  • Page 16 CAUTION: Only use the AC power cable provided by Masimo. Using a different AC power cable could cause damage to Rad-97. Check the power cord and plug to ensure that it is intact and undamaged.

  • Page 17: Performance Warnings And Cautions

    Performance Warnings and Cautions WARNING: Rad-97 should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. WARNING: The Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning;...
  • Page 18 Rad-97 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 , SpHb, SpOC, SpMet, SpCO, RRp, and ORi) can be affected by the following: •...
  • Page 19 Rad-97 Safety Information, Warnings and Cautions • Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (quantitative defects such as Thalassemias). • Extremely elevated hemoglobin levels. • Low arterial perfusion. • Low arterial oxygen saturation levels including altitude induced hypoxemia.
  • Page 20 CAUTION: ORi may not indicate additional changes in oxygen states above 200 mmHg of CAUTION: If using Rad-97 during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period.
  • Page 21 Note: Rad-97’s alarm capabilities have been designed to be independent of the Wi-Fi communication feature in order to preserve Rad-97's primary alarms. Note: Always charge Rad-97 when it is not in use to ensure that the Rad-97 Battery Module remains fully charged.

  • Page 22: Cleaning And Service Warnings And Cautions

    CAUTION: To avoid permanent damage to the Rad-97, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended.

  • Page 23: Compliance Warnings And Cautions

    Injury to personnel could occur. Compliance Warnings and Cautions WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful...
  • Page 24 Rad-97 Safety Information, Warnings and Cautions modifications made to the equipment without the approval of manufacturer could void the user's authority to operate this equipment. Note: To satisfy RF exposure requirements, this device and its antenna must operate with a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter.

  • Page 25: Chapter 1: Technology Overview

    Masimo products. Signal Extraction Technology® (SET®) Masimo Signal Extraction Technology's signal processing differs from that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the venous...
  • Page 26 SpO and pulse rate. Functional Oxygen Saturation (SpO2) The Rad-97 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 27 Rad-97 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 28: Rainbow Pulse Co-Oximetry Technology

    Rad-97 Chapter 1: Technology Overview 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. Biosci Trends. 2012 Feb;6(1):38-43. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J.
  • Page 29 The Rad-97 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle.
  • Page 30 Rad-97 Chapter 1: Technology Overview Once Rad-97 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient’s functional oxygen saturation (SpO [%]), blood levels of carboxyhemoglobin saturation (SpCO [%]), methemoglobin saturation (SpMet [%]), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (PR). The SpCO, SpMet and SpHb...
  • Page 31 Rad-97 Chapter 1: Technology Overview Successful Monitoring for SpHb A stable SpHb reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site. Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion.
  • Page 32 Rad-97 Chapter 1: Technology Overview The sensor collects signal data from the patient and sends it to the device. The device displays the calculated data as percentage value for the SpCO, which reflect blood levels of carbon monoxide bound to hemoglobin.

  • Page 33: Rainbow Acoustic Monitoring™ (Ram™)

    137. SpCO, SpMet, and SpHb Measurements During Patient Motion The Rad-97 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 34 Rad-97 Chapter 1: Technology Overview the lung tissue, thoracic wall and trachea to the surface where they may be heard with the aid of a stethoscope, a microphone or more sophisticated devices. rainbow Acoustic Monitoring Architecture The following figure illustrates how a respiratory sound produced by a patient can be turned into a numerical measurement that corresponds to a respiratory parameter.
  • Page 35 Rad-97 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 37: Chapter 2: Description

    Chapter 2: Description This chapter contains the description of the Rad-97 physical features. General System Description The Rad-97 system includes the following: • Rad-97 Device • AC Power Cord • Patient Cable • Sensor For a complete list of compatible sensors and cables, visit http://www.masimo.com.

  • Page 38: Features

    Rad-97 Chapter 2: Description Features Front View 1. Display and Touchscreen Provides a user interface to view and change settings. 2. Home Button Provides a multipurpose user interface that allows for navigation to the home screen as well as turning the device on and off.
  • Page 39 IEC 60601-1. 5. Power Entry Module Provides connection to an AC power cord. Note: Always connect the Rad-97 to the mains power for continuous operation and/ or battery recharging. Note: Use the power cord as the means to disconnect the device from AC power.
  • Page 40 The speaker provides audio alarms. Care should be taken not to cover the speaker. 2. Swivel Foot Provides stability when placing Rad-97 on a surface in a vertical position. 3. Foot Pads Provides physical support to Rad-97 when placed on a surface in a horizontal position.

  • Page 41: Chapter 3: Setting Up

    This chapter contains information about setting up Rad-97 before use. Unpacking and Inspection To unpack and inspect the Rad-97: Remove the Rad-97 from the shipping carton and examine it for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill of lading.

  • Page 42: Powering The Rad-97 On And Off

    The Home Button will illuminate Green and the Rad-97 will power on. To Power OFF Rad-97 When powering off the Rad-97, the device remembers the last settings if the Power on Profile is set to Previous Profile. See Access Control on page 94. The device also remembers the Device Mode when turned off, and will turn back on in that mode.

  • Page 43: Initial Battery Charging

    When Rad-97 is ON and fully charged, the AC Power Indicator will change to a plug icon. Touch the AC Power Indicator icon to view battery charge details. See Rad-97 Battery on page 93. For additional information, see Battery Operation and Maintenance on page 172.

  • Page 44: Attach Nibp Cuff

    Kite and the device are connected to the same network. To add Rad-97 to Kite to view parameter status, refer to the Masimo Kite Software Application Operator's Manual.

  • Page 45: Chapter 4: Operation

    Chapter 4: Operation The information in this chapter assumes that Rad-97 is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Rad-97 without completely reading and understanding these instructions.
  • Page 46 Using the Touchscreen Interface Using the gestures described below, the user is able to customize the viewing experience, including displaying the highest priority parameters and measurements. Feature navigation availability is dependent on which medical devices are connected to Rad-97. Action Illustration Example Description Touch and release.
  • Page 47 Rad-97 Chapter 4: Operation Below is a list of all the different types of controls available on Rad-97 and the various ways to interact with each type of control. Control Applicable Actions Description • Switches between toggle states Toggle Touch and slide knob •...
  • Page 48 Rad-97 Chapter 4: Operation Control Applicable Actions Description • When open, collapses spinner Touch anywhere outside spinner • Performs action (as defined by the button Button Touch description) • Opens menu specified by tile Icon Menu Touch tile • Scrolls icons left or right...
  • Page 49 Rad-97 Chapter 4: Operation Control Applicable Actions Description • Opens parameter or measurement trend Touch y-axis menu • Increases time range Trend Zoom Touch '+' • Decreases time range Touch '-' • Resets time range to default Touch time label •...

  • Page 50: About The Main Screen

    Rad-97 Chapter 4: Operation About the Main Screen The Main Screen consists of different areas. Ref. Feature Information See About the Status Bar on page 49. Status Bar See About the Action Menu on page 51. Action Menu Waveform View See Waveform Mode on page 79.
  • Page 51 Rad-97 Chapter 4: Operation About the Status Bar The Status Bar is visible at the top of the Main Screen. Ref. Feature Description Suspends all audible alarms and displays remaining Audio Pause Duration time when activated during an alarm event.
  • Page 52 Current Time time, language, and geography. See Localization on page 87. AC Power Indicator Whenever Rad-97 is connected to an AC power source and ON, the AC Power Indicator icon will appear on the display as follows: Icon Status Battery is currently charging Battery is fully charged Touch the AC Power Indicator icon to view battery charge details.
  • Page 53 Connect the battery to AC power to prevent the device from powering off and to charge the battery. When connected to power, the AC Power Indicator icon will be displayed. Touch the Battery Charge Status Indicator icon to view battery details. See Rad-97 Battery on page 93.
  • Page 54 Numeric View - Displays values in a standard grid view. Sensitivity Modes Overview Three sensitivity levels enable a clinician to tailor the response of Rad-97 to the needs of the particular patient situation. Sensitivity Modes are accessed through the Action Menu. See About the Action Menu on page 51.
  • Page 55 Rad-97 Chapter 4: Operation Understanding Windows The following information describes how to customize the information viewed on the Main Screen. Customizing Windows Windows can be customized by expanding and minimizing parameters and measurements in both Trend View and Numeric View. When a parameter is minimized, it is only displayed in the Well with its Numeric Value and Parameter Label.
  • Page 56 Rad-97 Chapter 4: Operation To minimize a parameter or measurement Order Instruction Step 1 Touch and hold the Numeric Value until it shrinks. Step 2 Drag the Numeric Value to the Well. Step 3 Release the Numeric Value. Customizing Trend View There are different ways to view trend information.
  • Page 57 Rad-97 Chapter 4: Operation In Trend View, a parameter or measurement is displayed as a graph of its values over time. The following diagram and table describe key features of a parameter's trend display in Trend View. Ref. Feature Description...

  • Page 58: About The System Status Light

    Rad-97 Chapter 4: Operation About the System Status Light The System Status Light provides visual indications of alarms and system messages. The light will illuminate in different colors depending on the state of the device. To locate the System Status Light, see Side and Top Views on page 38.

  • Page 59: Accessing Main Menu Options

    Rad-97 Chapter 4: Operation Accessing Main Menu Options To access Main Menu options, press the Main Menu icon in the bottom left corner of the touchscreen: The Main Menu options are: Parameter Settings Displayed on devices without NIBP. See Parameter Settings on page 60.
  • Page 60 Trends* See Trends on page 97. Rad-97 This icon is displayed when the Rad-97 is in optional Home mode (when available), allowing device settings to be changed. See Home on page 89. * This icon is neither available nor displayed in the Main Menu when the device is in optional Home mode (when available).
  • Page 61 To return to the Main Screen, press the Home Button at any time. rainbow Parameter Settings On Rad-97, the rainbow menu allows the user to view and customize settings for rainbow parameters: Parameter Settings See Parameter Settings on page 60.

  • Page 62: Parameter Settings

    Rad-97 Chapter 4: Operation Parameter Settings The following is an example of the Rad-97 Parameter Settings screen. To access any of the available parameter setting screens: From the Parameter Settings screen, to access the desired parameter, swipe the on-screen icons left or right.
  • Page 63 Rad-97 Chapter 4: Operation In Vivo Adjustment Overview In Vivo is currently not available in the U.S.A. and territories relying on FDA market clearance. The In Vivo Adjustment feature lets clinicians manually adjust the displayed value(s) of one or more clinical parameters to match a corresponding laboratory reference during continuous trending.
  • Page 64 Rad-97 Chapter 4: Operation SpO2 Settings Allows access to any of the following options: SpO2 Alarms on page 62 Additional Settings for SpO2 on page 63 In Vivo for SpO2 on page 64 Trends on page 97 About Parameter Information on page 78...
  • Page 65 When Rad-97 is set to FastSat On, the averaging algorithm evaluates all saturation values, providing an averaged saturation value that is a better representation of the patient’s current oxygenation status.
  • Page 66 Rad-97 Chapter 4: Operation In Vivo for SpO2 In Vivo is currently not available in the U.S.A. and territories relying on FDA market clearance. From the In Vivo screen, change any of the following options: Options Description Factory Default User Configurable...
  • Page 67 Rad-97 Chapter 4: Operation Pi Settings From the Pi Settings screen, access any of the following screens: Pi Alarms on page 65 Additional Settings for Pi on page 66 Trends on page 97 About Parameter Information on page 78 Pi Delta on page 130...
  • Page 68 Rad-97 Chapter 4: Operation Additional Settings for Pi From the Additional Settings screen, change the following option: Options Description Factory User Configurable Default Settings Settings Averaging The length of time over which the Long Short or Long Time system calculates the average of all data points.
  • Page 69 RRp is currently not available in the U.S.A. and territories relying on FDA market clearance. Rad-97 can determine Respiration Rate (RR) either by the acoustic signal (RRa) or the plethysmographic waveform (RRp). For more information, see: RRa Settings on page 68...
  • Page 70 Rad-97 Chapter 4: Operation RRa Settings RRa is active when the following conditions are all met: • RRa is installed on the Rad-97. • A dual rainbow cable is connected. • An acoustic sensor is connected. Note: See the Directions for Use provided with the acoustic sensor.
  • Page 71 RRp is currently not available in the U.S.A. and territories relying on FDA market clearance. When using a pulse oximetry or pulse CO-Oximetry sensor with Rad-97, respiration rate can be determined by the plethysmographic waveform (RRp). This method measures a patient's respiratory rate based on plethysmographic amplitude changes corresponding to the respiratory cycle.
  • Page 72 Rad-97 Chapter 4: Operation Note that Rad-97 can monitor RRa or RRp but not both simultaneously. RRp is active when the following conditions have all been met: • RRp is installed on the Rad-97. • No dual rainbow cable is connected.
  • Page 73 Rad-97 Chapter 4: Operation Additional Settings for RRp From the Additional Settings screen, change any of the following options: Options Description Factory User Configurable Default Settings Settings Averaging The length of time over which the Slow No Averaging, Fast, Time...
  • Page 74 Rad-97 Chapter 4: Operation SpHb 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 High 17.0 g/dL 2.0 g/dL to 24.5 g/dL in threshold that triggers steps of 0.1 g/dL, or Off...
  • Page 75 Rad-97 Chapter 4: Operation Additional Settings for SpHb From the Additional Settings screen, change any of the following options: Options Description Factory User Default Configurable Settings Settings Averaging The length of time over which the system Medium Short, Medium, Time calculates the average of all data points.
  • Page 76 Rad-97 Chapter 4: Operation SpOC Settings From the SpOC Settings screen, access the following screens: SpOC Alarms on page 74 Trends on page 97 About Parameter Information on page 78 SpOC Alarms From the SpOC Alarms screen, access the following screens:...
  • Page 77 Rad-97 Chapter 4: Operation SpMet Alarms From the Alarms screen, change any of the following options: Options Description Alarm Factory User Configurable Priority Default Settings Settings High Limit High Alarm Limit is the High 1.0% to 2.0% in upper threshold that steps of 0.1%...
  • Page 78 Rad-97 Chapter 4: Operation SpCO Settings From the SpCO Settings screen, access the following screens: SpCO Alarms on page 76 In Vivo for SpCO on page 76 Trends on page 97 About Parameter Information on page 78 SpCO Alarms From the SpCO Settings screen, access the following screens:...
  • Page 79 Rad-97 Chapter 4: Operation Options Description Factory Default User Configurable Settings Settings See In Vivo Adjustment Offset 0.0 when turned -9.0% to +9.0% in steps Amount Overview on page 61. of 0.1% ORi Settings ORi is currently not available in the U.S.A. and territories relying on FDA market clearance.
  • Page 80 Rad-97 Chapter 4: Operation About Parameter Information Additional information about each parameter is available. To access additional information about parameters: From the Parameter Settings screen, touch the About icon. The following is an example for SpO An About screen appears for the selected parameter and displays information about the parameter.
  • Page 81 Rad-97 Chapter 4: Operation Option Description Factory User Configurable Settings Default Settings low % Set the SpO Off, 1% to 98% limit limit alarm. See SpO2 Settings on page 62. Waveform Mode The following section contains examples of some of the waveforms viewable on the Main Screen.

  • Page 82: Noninvasive Blood Pressure (Nibp) Settings

    (if RRa is available). Noninvasive Blood Pressure (NIBP) Settings Note: This feature is optional on Rad-97 devices. The NIBP menu allows the user to view and customize settings for the NIBP module by changing any of the following options: Parameter Settings See Parameter Settings for Noninvasive Blood Pressure (NIBP) on page 81.
  • Page 83 Rad-97 Chapter 4: Operation Parameter Settings for Noninvasive Blood Pressure (NIBP) From the NIBP screen, touch Parameter Settings, and then change individual parameter settings/alarms by selecting one of the following parameters: Systolic/Diastolic See SYS/DIA Settings on page 81. Mean Arterial Pressure See MAP Settings on page 82.
  • Page 84 Rad-97 Chapter 4: Operation Factory Alarm User Configurable Options Description Default Priority Settings Settings Off, or 41-258 in Low Limit is the lower steps of 1 Systolic Low threshold that triggers an Medium Limit When set to Off, alarm. alarm is disabled...
  • Page 85 Rad-97 Chapter 4: Operation MAP Alarms From the Mean Arterial Pressure screen, touch Alarms, and then change any of the following options: Factory Alarm User Configurable Options Description Default Priority Settings Settings 28-219 in steps of 1, High Limit is the upper...
  • Page 86 Rad-97 Chapter 4: Operation Intervals for NIBP From the NIBP screen, touch Intervals, and then change any of the following options: Options Description Factory User Configurable Default Settings Settings Set Mode The mode of measurement for NIBP. Automatic Automatic or Stat Note: Option available when Automatic mode is selected.

  • Page 87: Sounds

    Use the Sounds screen to control the volume of sounds and duration of audio pause on Rad-97. Users can also access the Sounds screen by pressing the Sounds icon on the Status Bar. See About the Status Bar on page 49.

  • Page 88: Device Settings

    Permanent is active. Device Settings The Device Settings menu allows the user to view and customize settings for Rad-97. Note: When in Home mode, items below marked with an * are displayed in the Main Menu; no other device settings are available. See Home on page 89.
  • Page 89 Factory Default User Configurable Settings Settings Select the language display Choose from available Language English for Rad-97. languages. Date Format Set the display format for mm/dd/yy mm/dd/yy or dd/mm/yy current date. Time Format Set the display format for 12 hour 12 or 24 hour current time.
  • Page 90 The Device Mode screen allows the user to select the device operating mode. Continuous Monitoring is the default device mode. When the Rad-97 is turned off, the device mode is stored. Rad-97 will start in the same mode when turned on again.
  • Page 91 Profiles, Device Settings, and Trend Settings are not displayed in the Main Menu. Change Settings/Exit Home Mode To change settings or switch to a different device mode, select the Rad-97 menu from the Main Menu. When the screen displays, press the key.
  • Page 92 Chapter 4: Operation Sleep Study When in Sleep Study mode, Rad-97 operates using the Continuous Monitoring settings in effect at the time Sleep Study mode is enabled (Profiles, Alarms, etc.). Rad-97 operation changes as follows when in Sleep Study mode: •...
  • Page 93 Rad-97 Chapter 4: Operation Screen Orientation Use Screen Orientation to set screen preferences. From the Screen Orientation screen, change any of the following options: Options Description Factory Default User Configurable Settings Settings Auto Allows the device to Off or On...
  • Page 94 Wi-Fi communication in order to ensure alarms are received. Use the Wi-Fi screen to enable or disable Wi-Fi connectivity. When Rad-97 is connected to a Wi-Fi network, the Wi-Fi icon on the Status Bar indicates the strength of the connection. The user can also access the Wi-Fi screen by pressing the Wi-Fi icon on the Status Bar.
  • Page 95 Your Masimo sales representative can provide necessary information regarding an initial Bluetooth connection. Note: Presence Monitoring must be disabled in order for Rad-97 to function. For more information on how to configure the Masimo MyView Presence Tag, see the Masimo Patient SafetyNet Operator's Manual.
  • Page 96 Description State of Charge Provides a read-only display of battery level remaining. Battery Diagnostics Allows trained personnel to access battery diagnostic information. Brightness Use the Brightness screen to adjust the brightness of Rad-97's display. Option Description Factory User Configurable Default...
  • Page 97 Rad-97 Chapter 4: Operation To undo an entry, press Backspace. Press Enter to access the password-protected screen. Note: The password will have to be entered every time this screen is accessed. Option Description Factory User Configurable Settings Default Settings Sets the profile used when the...
  • Page 98 Rad-97 Chapter 4: Operation Device Output The Device Output screen allows the user to configure additional data output options. A Nurse Call can be triggered based on alarm, low Signal IQ events, or both. In addition, Nurse Call Polarity can be inverted to accommodate local Nurse Call station requirements.

  • Page 99: About

    About For information about individual parameters, see About Parameter Information on page 78. Use the About screen to view the serial number as well as Rad-97 software and hardware version information. These details may be helpful during troubleshooting. Option * Description Serial Number Displays the serial number for the device.
  • Page 100 Rad-97 Chapter 4: Operation Option Description Factory Default User Configurable Settings Settings Y-axis Min 0 to 95 in steps of 5 Y-axis Max 5 to 100 in steps of 5 Y-axis Min 25 to 235 in steps of 5 Y-axis Max 30 to 240 in steps of 5 0.0 to 24.9 g/dL in...

  • Page 101: Rad-97 Screenshot Capture

    See Home on page 89. Rad-97 Screenshot Capture The user is able to take screenshots of Rad-97 displays and download them as .png files onto a USB drive. To ensure quick downloads, the number of screenshots that can be stored in Rad-97 is limited to 20;...
  • Page 102 “screen_shot” in the USB drive with a FAT or FAT32 system file to enable the download of the screenshots. Plug the USB drive into the USB port located on the back side of Rad-97 (see Back View on page 37), and the screenshots will automatically download. A status message will display briefly at the top of the Rad-97 screen to indicate the start of the download.

  • Page 103: Patient Admit/Discharge

    Rad-97 Chapter 4: Operation Patient Admit/Discharge When configured, this function allows the user to admit and discharge a patient through Patient SafetyNet. Depending on patient status, different icons display on the Main Screen. Icon Name Description Admit Select to admit a patient.

  • Page 105: Chapter 5: Profiles

    Displays in the Status bar as NEO and the color of the Profile button turns Pink. If the Profile setting is changed to NEO, Rad-97 will remain in the previously selected Profile setting even after the device is powered off and on again.
  • Page 106 Rad-97 Chapter 5: Profiles • Select Profiles from the Main Menu as shown below. Once the Profiles screen displays you can switch to a different profile or choose a different patient category (Adult, Pediatric, Neonate) for the selected profile. www.masimo.com...
  • Page 107 Rad-97 Chapter 5: Profiles To switch to a different profile: From the Profiles screen, touch the Profile Name field. Select the desired profile by scrolling up or down. When finished, touch OK. To confirm selection, check the Status Bar. The Home Button color will change as follows, depending on the profile selected: •...

  • Page 108: Profiles Settings

    Chapter 5: Profiles Profiles Settings The Rad-97 can be configured for various patient types through the Profiles option located under the main menu options. See Accessing Main Menu Options on page 57. Use the Profiles Settings screen to select patient type.

  • Page 109: Replacing Factory Default Settings For Adult, Pediatric And Neonatal Profiles

    Profile button still changes to the same Blue, Green or Pink color, respectively. See Profiles Overview on page 103. The user can also load preferred profile settings into the Rad-97 using a separate tool. To change the factory default settings for Adult, Pediatric or Neonatal profile settings Change Rad-97 settings to the desired configuration.

  • Page 111: Chapter 6: Noninvasive Blood Pressure (Nibp)

    Operation - NIBP Note: This feature is optional on Rad-97 devices. Rad-97 works by noninvasively monitoring the amplitude of cuff pressure changes during cuff deflation to determine arterial blood pressure. The cuff pressure is first elevated above the patient's systolic blood pressure level. The cuff will then begin to deflate at a certain rate. The initial rise in the amplitude of pressure fluctuations during cuff deflation corresponds closely to the systolic blood pressure.

  • Page 112: Cuff Selection And Placement

    Note: It is recommended that 5 minutes elapse before the first reading is taken. Cuff Selection and Placement Rad-97 uses a quick connect hose with a blood pressure cuff to measure NIBP. Based on the cuff type selected, use the following approved blood pressure cuff chart to choose sizes.
  • Page 113 Rad-97 Chapter 6: Noninvasive Blood Pressure (NIBP) To ensure the correct cuff size Wrap the cuff around the arm. The index line should align within the cuff range markings If the index line does not fit within the range markings, select a larger or smaller cuff.

  • Page 114: Blood Pressure Measurement

    Spot Check NIBP Measurement Ensure that the correct patient profile is selected before measurement. WARNING: Only use Rad-97 in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. Note: The Patient Category determines the initial inflation pressure of NIBP.
  • Page 115 To measure blood pressure in Automatic Interval Measurement Mode Ensure that the correct patient profile is selected before measurement. WARNING: Only use Rad-97 in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. To change the patient profile, touch the Main Menu icon , then select Profiles Touch the Profile Name and select the desired patient profile.
  • Page 116 To measure blood pressure in Stat Interval Measurement Mode Ensure that the correct patient profile is selected before measurement. WARNING: Only use Rad-97 in Neonatal mode with a neonatal blood pressure cuff to measure blood pressure on neonates. To change the patient profile, touch the Main Menu icon , then select Profiles Touch the Profile Name to select the desired patient profile.
  • Page 117 Rad-97 Chapter 6: Noninvasive Blood Pressure (NIBP) Properly place the blood pressure cuff on patient. See Cuff Selection and Placement on page 110. To enable Stat mode, touch the Main Menu icon , then select NIBP Settings On the Intervals screen, change Set Mode to Stat, and then select the desired Stat Duration.

  • Page 119: Chapter 7: Admit To And Discharge From Patient Safetynet

    Not Admitted A Not Admitted message will appear on the Rad-97 screen when the sensor is placed onto a patient and a patient has not yet been admitted on Rad-97. Press the Admit button on the screen to admit the patient or press Skip and the patient data will not be transmitted to Patient Safety Net.

  • Page 120: Admitting A Patient

    Rad-97 Chapter 7: Admit to and Discharge from Patient SafetyNet Admitting a Patient Press the Admit icon on the bottom left of the screen to open the Patient screen. Select the patient name by pressing the Search button (see Fig. 1).
  • Page 121 When the sensor is off the patient for an extended period of time, a Not Monitoring message will appear on the screen. Acknowledge the message by pressing Cancel or Discharge. Press Discharge to discharge the patient that is currently admitted on Rad-97, or press Cancel to keep the same patient admitted.

  • Page 122: Discharging A Patient

    Rad-97 Chapter 7: Admit to and Discharge from Patient SafetyNet Discharging a Patient Press the Discharge icon on the bottom left of the screen to open the Patient screen. Select the Discharge button on the bottom of the screen (see Fig. 4).

  • Page 123: Chapter 8: Third-Party Devices

    Rad-97 can display parameters and measurements captured by third-party technologies in an all-in-one view on Rad-97. When a third-party device is connected, Rad-97 automatically creates a window that displays all the data from that device on the Main Screen. Connect Device to Rad-97 To connect a third-party device to Rad-97 using Bluetooth, perform the following: Ensure Bluetooth is enabled on Rad-97.

  • Page 125: Chapter 9: Alarms And Messages

    Window Level: The example shown here is an alarm in the lower NIBP Window. Note that the border of the Window illuminates yellow, and the explanation of the alarm is shown at the top of the Window (Systolic High). www.masimo.com Masimo...

  • Page 126: About Alarms

    Alarm Source/Example Explanation System Level: The example shown here is a "No Cable Connected" alarm. Note that the border of the entire Rad-97 display is illuminated, and the explanation of the alarm is shown in the Status Bar (No Cable Connected).
  • Page 127 Rad-97 Chapter 9: Alarms and Messages Silencing Alarms Alarms are conveyed in several ways: audibly, visibly, or both ways simultaneously. To silence or dismiss alarms: • Touch Silence in the highlighted area of the Status Bar or the Alarm Silence button.
  • Page 128 Silence Duration feature located in the Alarms menu for each parameter. Audio Pause Audio Pause temporarily suspends all audible alarms on Rad-97. When it is active, visual alarms are not impacted and will still display. The Audio Pause icon is located on the left side of the Status Bar;...

  • Page 129: Adaptive Threshold Alarm (Ata) Feature

    Audio Pause is inactive again (alarms audible again). To configure Audio Pause, see Sounds on page 85. Note: When Audio Pause is activated, powering off and then powering on Rad-97 will return Audio Pause to its default inactive state. Adaptive Threshold Alarm (ATA) Feature ATA is currently not available in the U.S.A.

  • Page 130: 3D Alarms

    Rad-97 Chapter 9: Alarms and Messages Note: ATA does not allow a Rapid Desat setting of 0%. When ATA is turned Off, the device uses the standard alarm limits and standard alarm delays. See About Alarms on page 124 See SpO2 Alarms on page 62...
  • Page 131 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 Rad-97 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 130.

  • Page 132: Messages

    None or 1, 5, 30 percent change in Pi is monitored. minutes, 1, 4, 8, 12, 24, 36, 48 hours Messages The following section lists common Rad-97 messages, potential causes, and next steps. Message Potential Causes Next Steps • •...
  • Page 133 10% patient monitoring time sensor. Adhesive Near remaining. Expiration (RAM) Adhesive Near Expiration • • Not a proper Masimo sensor. Replace with a proper (Pulse CO-Ox) Masimo sensor. Incompatible • Sensor is attached to a device Sensor • without an appropriate Use a compatible sensor.
  • Page 134 Rad-97 Chapter 9: Alarms and Messages Message Potential Causes Next Steps • • Not a proper Masimo sensor. Replace with a proper (Pulse CO-Ox) Masimo sensor. Incompatible • Sensor is attached to a device Adhesive Sensor • without an appropriate Use a compatible sensor.
  • Page 135 Rad-97 Chapter 9: Alarms and Messages Message Potential Causes Next Steps • • Device is checking the sensor If values are not displayed (RAM) Sensor for proper function and within 30 seconds, Initializing performance. disconnect and reconnect sensor. If values are still not displayed, replace with a new sensor.
  • Page 136 Occurs during an unsuccessful See the Directions for Use (Pulse CO-Ox) sensor initialization/pulse provided with your sensor. Only Mode search routine or during Use a Masimo light shield to monitoring. cover the sensor and adjust the sensor. • • Indicates low signal confidence...

  • Page 137: Noninvasive Blood Pressure (Nibp) Messages

    Message Potential Causes Next Steps • • Device requires service. Contact Masimo Technical RTC Battery Low Support. See Chapter 12: Service and Maintenance on page 167. Noninvasive Blood Pressure (NIBP) Messages The following section lists common NIBP messages, their potential causes, and next steps.
  • Page 138 Maintenance on page 167. Required or there has been a calibration • If problem still persists, data failure. contact Masimo Technical Support. • Contact Masimo Technical Support. See Chapter 12: Module Error • Device requires service.

  • Page 139: Chapter 10: Troubleshooting

    Check the placement of the • Low perfusion. sensor. Re-apply sensor or move to a different site. • Replace sensor. • Minimize or eliminate motion at the monitoring site. • Set to Maximum Sensitivity. See Sensitivity Modes Overview on page 52. www.masimo.com Masimo...
  • Page 140 Rad-97 Chapter 10: Troubleshooting Symptom Potential Causes Next Steps • • Inappropriate Allow time for parameter reading Difficulty obtaining a sensor or sensor to stabilize. reading. size. • Verify sensor type and size and • Improper sensor re-apply sensor. See Directions for type or application.
  • Page 141 Rad-97 Chapter 10: Troubleshooting Symptom Potential Causes Next Steps • Low signal quality. • Assess the patient. Dimly Lit Parameters • Verify sensor type and size and re-apply sensor. See Directions for Use for sensor. • Check if blood flow to the sensor site is restricted.

  • Page 142: Troubleshooting Rad-97

    Rad-97 Chapter 10: Troubleshooting Troubleshooting Rad-97 The following section lists possible Rad-97 symptoms, potential causes, and next steps. For more information, see Chapter 9: Alarms and Messages on page 123. Symptom Potential Causes Next Steps • • Depleted Battery. Check AC Power Device does not turn on connection.
  • Page 143 Rad-97 Chapter 10: Troubleshooting Symptom Potential Causes Next Steps • • The device is Off. Turn Rad-97 Off and Device screen is blank • The brightness display • is not correct. Adjust the brightness setting. See Brightness • Battery may be on page 94.
  • Page 144 • Sensor expired. patient. Refer to sensor Directions For Use. • Internal failure. • Replace sensor. • Turn Rad-97 Off and • Contact Masimo service. See Contacting Masimo on page 173. • • Nurse call connector Check Nurse call Nurse Call does not work...
  • Page 145 • Location does not have • wireless availability. Check wireless availability for • Connected network is location. not available. • Check network settings • Internal failure. and availability. • Contact Masimo service. See Contacting Masimo on page 173. www.masimo.com Masimo...

  • Page 147: Chapter 11: Specifications

    Chapter 11: Specifications The following chapter contains specifications for the Rad-97. Pulse CO-Oximetry Specifications Display Range Measurement Display Range (Functional Oxygen Saturation) 0% to 100% PR (Pulse Rate) 0 bpm to 240 bpm Pi (Perfusion Index) 0.00 to 0.99 PVi (Pleth Variability Index)
  • Page 148 Rad-97 Chapter 11: Specifications Accuracy (ARMS*) Oxygen Saturation (SpO No Motion [1] Adults, Pediatrics, Infants (SpO from 60% to 80%) Adults, Pediatrics, Infants No Motion [2] (SpO from 70% to 100%) Neonates Motion [3] from 70% to 100%) All patient populations...
  • Page 149 *** Breaths per minute is denoted as rpm on device display. ****Parameter currently not available in the U.S.A. and territories relying on FDA market clearance. Note: A functional tester cannot be used to assess the accuracy of Rad-97. www.masimo.com Masimo...
  • Page 150 The tables below provides (Accuracy Root Mean Square) values measured using the Masimo Rainbow SET Technology with Masimo RD SET disposable sensors in clinical studies under no motion conditions. The Bland-Altman plots provided in the operator’s manual are for the sensors identified in the respective plots.
  • Page 151 Rad-97 Chapter 11: Specifications The below Bland-Altman plot represents the correlation of the (SpO + SaO )/2 versus (SpO ) under no motion with an upper 95% and lower 95% limits of agreement. Figure 1: Disposable (RD SET Series) Sensors (ARMS 70-100%)

  • Page 152: Noninvasive Blood Pressure (Nibp) Specifications

    Rad-97 Chapter 11: Specifications Parameter Resolution SpMet 0.1% SpOC 1.0 ml/dL RRp** 1 RPM * Breaths per minute is denoted as rpm on device display. ** Parameter currently not available in the U.S.A. and territories relying on FDA market clearance.

  • Page 153: Electrical

    Rad-97 Chapter 11: Specifications Accuracy Pressure Transducer Between 0 mmHg and 300 mmHg ±3mmHg Pressure Range Weight Patient Initial Maximum Category Pressurization Pressure Greater than 75 lbs (34 kg) Adult 160 mmHg 280 mmHg Between 15.4 - 75 lbs (7 - 34...

  • Page 154: Environmental

    Rad-97 Chapter 11: Specifications Environmental Environmental Conditions 0°C to 35°C Operating Temperature (32°F to 95°F) -20°C to 60°C [11] Storage/Transport Temperature (-4°F to 140°F) Operating Humidity Non-NIBP 10% to 95%, non-condensing NIBP 15% to 95%, non-condensing Storage/Transport Humidity Non-NIBP 10% to 90%, non-condensing...

  • Page 155: Alarms

    Rad-97 Chapter 11: 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 Flashing yellow 550 Hz tone, 3-pulse burst, pulse spacing: 0.375s, 0.375s,...

  • Page 156: Compliance

    Rad-97 Chapter 11: Specifications Compliance EMC Compliance IEC 60601-1-2:2007, Class B EN/ISO 80601-2-61:2011, Clause 202.6.2.3, 20 V/m Safety Standards Compliance ANSI/AAMI ES 60601-1:2005 CAN/CSA C22.2 No. 60601-1 IEC 62366 IEC 60601-1-6 IEC 60601-1:2005 IEC 60601-1-8 IEC 60601-1-11 IEC 60601-2-49 IEC 80601-2-30 (NIBP)

  • Page 157: Connectors

    Rad-97 Chapter 11: Specifications Equipment Classification per IEC 60601-1 Protection against IP22, Protection from ingress of particulates > than 12.5 mm and harm from liquid protection against vertically falling water drops when enclosure is ingress tilted at 15 degrees. Mode of Operation...
  • Page 158 Rad-97 Chapter 11: Specifications Communication (Wi-Fi) 802.11a - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. Available Data Rates 802.11b - 1, 2, 5.5, 11 Mbps. 802.11g - 6, 9, 12, 18, 24, 36, 48, 54 Mbps. Communication (Bluetooth)
  • Page 159 Rad-97 Chapter 11: Specifications Radio Compliance FCC ID: VKF-MWM1 Model - RAD-97 Canada IC:7362A-MWM1 IC Model: MWM1 RSS-210 Europe EN 300 328 EN 301 893 EN 301 489-1 EN 301 489-17 R & TTE Directive Japan TELEC www.masimo.com Masimo...

  • Page 160: Guidance And Manufacturer's Declaration-Electromagnetic Emissions

    Rad-97 Chapter 11: Specifications Guidance and Manufacturer's Declaration-Electromagnetic Emissions Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
  • Page 161 Rad-97 Chapter 11: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity IEC 61000-4-2 +8 kV air humidity should be at least 30%. Electrical fast +/- 2 kV +/- 2 kV for Mains power quality should be that of a transient/ burst...
  • Page 162 Rad-97 Chapter 11: Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity Conducted RF IEC 3 Vrms 3 Vrms 61000-4-6 Radiated RF IEC 20 V/m 20 V/m 61000-4-3 80 MHZ to 2.5 GHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz...

  • Page 163: Recommended Separation Distances

    Rad-97 Chapter 11: Specifications 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...

  • Page 164: Symbols

    Rad-97 Chapter 11: 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 ETL Intertek certification Mark of conformity to European medical device See Declarations on Page 1 for...
  • Page 165 (polyvinyl chloride) material Not made with natural rubber Caution latex Catalog number (model Manufacturer number) Date of manufacture Masimo reference number YYYY-MM-DD Storage temperature range Serial number Keep dry Fragile, handle with care Do not use if package is Storage humidity limitation...

  • Page 166: Citations

    Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70%-100% SpO against a laboratory CO-Oximeter and ECG monitor. [4] The Rad-97 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 167 [8] Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and Instrument has been validated for the range of 4 to 70 respirations per minute in bench top testing. Clinical validation for up to 30 respirations per minute was also performed with the Masimo Acoustic Respiration sensor and instrument.

  • Page 169: Chapter 12: Service And Maintenance

    Cleaning The Rad-97 is a reusable device. The device is supplied and is intended to be used non-sterile. WARNING: To avoid electric shock, always turn off the Rad-97 and physically disconnect the AC power and all patient connections before cleaning.

  • Page 170: Performance Verification

    To test the performance of the Rad-97 following repairs or during routine maintenance, follow the procedure outlined in this chapter. If the Rad-97 fails any of the described tests, discontinue its use and correct the problem before returning the device back to the user.
  • Page 171 Connect one end of a Nurse Call interconnection cable with 1/4" round connector on each end to the nurse call port of the Rad-97. See Back View on page 37. Connect the common lead of a digital multi-meter to the pin 12 of the Nurse Call (Common) connector on the Rad-97.

  • Page 172: Calibration

    Rad-97 Chapter 12: Service and Maintenance Calibration Noninvasive Blood Pressure NIBP Module Calibration Note: This section is provided as a reference and intended for qualified service professionals only. Pass Criteria International standards for automated NIBP devices require that the maximum static pressure accuracy shall be ±...
  • Page 173 Rad-97 Chapter 12: Service and Maintenance Check the "Result" section, if the leak rate is greater than 6 mmHg/min, contact customer service. Zero Point Calibration Note: This section is provided as a reference and intended for qualified service professionals only.

  • Page 174: Maintenance

    Note: When battery run time is significantly reduced, it is advisable to completely discharge and fully recharge the battery. Run Time for Rad-97 The following table outlines the estimated minimum run time of the battery in the Rad-97. • The time estimates are based on a fully charged battery.

  • Page 175: Repair Policy

    Warranty information, a copy of the invoice or other applicable documentation must be included. • Purchase order number to cover repair if the Rad-97 is not under warranty, or for tracking purposes if it is. • Ship-to and bill-to information.
  • Page 176 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 177 Sales & End-User License Agreement This document is a legal agreement between you (“purchaser”) and Masimo Corporation (“Masimo”) for the purchase of this Product (“Product”) and a license in the included or embedded Software (“Software”) except as otherwise expressly agreed in a separate contract for the acquisition of this Product, the following terms are the entire agreement between the parties regarding your purchase of this Product.

  • Page 179: Appendix: Concepts Of Alarm Response Delay

    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 Saturation Time www.masimo.com Masimo...
  • Page 180 Rad-97 Appendix: Concepts of Alarm Response Delay 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 181: Index

    Chapter 3 Additional Settings for RRp • 67, 70, 71 Setting Up • 39 Additional Settings for SpHb • 71, 73 Chapter 4 Additional Settings for SpO2 • 62, 63, 90 Operation • 43 Admitting a Patient • 118 www.masimo.com Masimo...
  • Page 182 Compliance Warnings and Cautions • 21 General Description for Methemoglobin Concepts of Alarm Response Delay • 177 (SpMet) • 30 Connect Device to Rad-97 • 121 General Description for Oxygen Reserve Connectors • 155 Index (ORi) • 31 Contacting Masimo • 140, 141, 142, 143, General Description for Oxygen Saturation (SpO2) •...
  • Page 183 Patient Category • 109 MAP Settings • 81, 82 Patient Conditions • 109 Masimo Kite • 42 Patient SafetyNet • 20 Masimo rainbow SET® Parallel Engines • Performance Verification • 168 Masimo SET® DST • 24 Performance Warnings and Cautions • 15 www.masimo.com...
  • Page 184 Respiration Rate (RR) Settings • 60, 67 Pleth + Sig IQ + Acoustic View • 80 Restrictions • 175 Powering the Rad-97 ON and OFF • 40, Return Procedure • 39, 173 RRa Alarms • 67, 68 Power-On Self-Test • 168 RRa Settings •...
  • Page 185 Successful Monitoring for SpO2, PR and Pi • 24 Symbols • 162 SYS/DIA Alarms • 81 SYS/DIA Settings • 81 Testing with the optional Masimo SET Tester • 169 Third-Party Devices • 42 Touchscreen Function Test • 169 Trend Settings • 97 Trends •...
  • Page 188 38281/LAB-9275B-0917...

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