Radical-7 Operator's Manual
The Radical-7 operating instructions provide the necessary information for proper operation of all models of the Radical-7 Pulse CO-Oximeter system. 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 the Radical-7 are prerequisites for its proper use. Do not operate the Radical-7 without completely reading and understanding the instructions in this manual.
Contents About this Manual -------------------------------------------------------------------------------------------7 Product Description, Indications for Use, Contraindications, and Features ---------------------- 9 Product Description ------------------------------------------------------------------------------------- 9 Indications for Use------------------------------------------------------------------------------------- 10 Contraindications -----------------------------------------------------------
Radical-7 Contents Using Screen Lock ------------------------------------------------------------------------------------- 46 Using the Home Button ------------------------------------------------------------------------------ 46 Navigating the Radical-7 ----------------------------------------------------------------------------- 47 About the Display View ------------------------------------------------------------------------------- 48 Sensitivity Modes Overview -----------------------------------------
Radical-7 Contents Trending ----------------------------------------------------------------------------------------------- 118 Alarms-------------------------------------------------------------------------------------------------- 119 Display Indicators ------------------------------------------------------------------------------------ 120 Compliance--------------------------------------------------------------------------------------------- 121 Output Interface-----------------------------------------
About this Manual This manual explains how to set up and use the Radical-7 Pulse CO-Oximeter. Important safety information relating to general use of the Radical-7 appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse affect, death) to the patient or user.
Product Description, Indications for Use, Contraindications, and Features The following chapter contains the Radical-7 product description, key features and benefits, indications for use, contraindications, and safety information, including cautions, warnings, and notes.
Radical-7 • Product Description, Indications for Use, Contraindications, and Features Signal IQ waveform for signal identification and quality indication during excessive motion and low signal to noise situations. • FastSat tracks rapid changes in arterial O2. • Variable pitch provides tonal variance for every 1% change in saturation.
Safety Information, Warnings, and Cautions The following section lists warnings, caution, notes, and safety information. The Radical-7 is designed to minimize the possibility of hazards from errors in the software program by following sound Engineering Design Processes, Risk Analysis and Software Validation. The Radical-7 is to be operated by qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use.
Radical-7 Safety Information, Warnings, and Cautions Warning The Radical-7 cannot measure elevated levels of COHb or MetHb. Warning Inaccurate SpO2 readings may be caused by: • Elevated levels of COHb and MetHb • For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is approximately equal to the amount of COHb that is present. • Note: High levels of COHb may occur with a seemingly normal SpO2.
Radical-7 Safety Information, Warnings, and Cautions Warning Inaccurate SpHb and SpOC readings may be caused by: • Intravascular dyes such as indocyanine green or methylene blue • Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
Radical-7 Safety Information, Warnings, and Cautions Warning Inaccurate respiration rate measurements may be caused by: • Low arterial perfusion • Motion artifact • Low arterial oxygen saturation • Excessive ambient or environmental noise • Improper sensor placement Caution If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to completely understand the patient’s condition.
Radical-7 Safety Information, Warnings, and Cautions Warning Explosion hazard: Do not use the Radical-7 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. Warning Do not use the Radical-7 or sensor during magnetic resonance imaging (MRI) scanning. Warning Do not place the Radical-7 or accessories in any position that might cause it to fall on the patient.
Radical-7 Safety Information, Warnings, and Cautions Warning Do not autoclave, pressure sterilize, or gas sterilize the Radical-7. Warning Do not touch, press, or rub the display panels with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the panel. Warning Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Radical-7.
Radical-7 Safety Information, Warnings, and Cautions This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Radical-7 Safety Information, Warnings, and Cautions Electrical Safety Information, Warnings, and Cautions This section contains electrical related safety information. Warning Fire Hazard: To protect against fire hazard, replace only with fuses of same type, current rating, and voltage rating. Caution Do not place the Radical-7 on electrical equipment that may affect the instrument, preventing it from working properly.
Radical-7 Safety Information, Warnings, and Cautions Caution Do not under any circumstances remove the grounding conductor from the power plug. Caution Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. Caution To ensure patient electrical isolation, connect only to other equipment with electrically isolated circuits. Caution Do not connect to an electrical outlet controlled by a wall switch or dimmer.
Radical-7 Safety Information, Warnings, and Cautions The battery should be installed and/or removed from the Radical-7 by qualified personnel only. All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the battery. All external device connections to the RS-232 serial port must be IEC-60950 compliant. The Docking Station battery should be installed and/or removed from the Docking Station only by qualified personnel.
Radical-7 Safety Information, Warnings, and Cautions Caution During SatShare operation, the audible alarms may be muted on the Radical-7. When the audible alarm is muted (indicated by a bell with a slash through it) on the Radical-7, use the multi-parameter monitor for audible alarm indication. Caution If an alarm condition occurs while the Alarm Silence period is set to All Mute, the only alarm indications will be visual display and symbols related to alarm condition. No alarm will sound.
Radical-7 Safety Information, Warnings, and Cautions Do not expose the Masimo sensors used with Radical-7 to moisture, liquids or a humid environment, as this may make the sensor perform inaccurately or fail. High-intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on the sensor, may not allow the Radical-7 to obtain readings. When using the Maximum Sensitivity setting, performance of the Sensor Off detection may be compromised.
Chapter 1: Technology Overview The following chapter contains general descriptions about parameters, measurements, and the technology used by 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.
Radical-7 Chapter 1: Technology Overview Masimo SET DST This figure is for conceptual purposes only. General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: 1. 2. 3. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). The amount of arterial blood in tissue changes with your pulse (photoplethysmography).
Radical-7 Chapter 1: Technology Overview General Description for Pulse Rate (PR) Pulse rate (PR) , measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse. General Description for Perfusion Index (PI) The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue. PI thus represents a noninvasive measure of peripheral perfusion that can be continuously and noninvasively obtained from a pulse oximeter.
Radical-7 Chapter 1: Technology Overview The Radical-7 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma. The Radical-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector).
Radical-7 Chapter 1: Technology Overview blood) a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin, and methemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry measurements of SpO2, SpCO, SpMet, SpHb, and SpOC may vary with the rapid administration of fluids and in procedures such as dialysis.
Radical-7 Chapter 1: Technology Overview General Description for SpOC The above approximations result in the following reduced equation for oxygen content via the Pulse CO-Oximeter: SpOC (ml/dL*) = 1.31 (ml O2/g Hb) x SpHb (g/dL) x SpO2 + 0.3 ml/dL *When ml O2/g Hb is multiplied by g/dL of SpHb, the gram unit in the denominator of ml/g cancels the gram unit in the numerator of g/dL resulting in ml/dL (ml of oxygen in one dL of blood) as the unit of measure for SpOC.
Radical-7 Chapter 1: Technology Overview Successful Monitoring for SpMet A stable SpMet reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient’s fingertip (measurement site). Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. See Safety Information, Warnings, and Cautions on page 11.
Radical-7 Signal Processing Chapter 1: Technology Overview Envelope Detection RRa Estimation Digital signal to respiratory measurement Patient The generation of respiratory sounds is primarily related to turbulent respiratory airflow in upper airways. Sound pressure waves within the airway gas and airway wall motion contribute to the vibrations that reach the body surface and are recorded as respiratory sounds.
Radical-7 Chapter 1: Technology Overview Signal Processing The digital signal produced by the acquisition system is converted into a measurement that corresponds to the respiratory parameter of interest. As shown in the previous figure, this can be performed by, for example, determining the digital signal envelope or outline which in turn may be utilized to determine the respiratory rate.
Chapter 2: Radical-7 Descriptions The following chapter contains the Radical-7 descriptions, including descriptions of the Handheld monitor , the Standalone monitor, and the optional SatShare monitor interface. General System Description The Radical-7 system includes the following: 1. 2. 3. Instrument Patient Cable Sensor www.masimo.
Radical-7 Chapter 2: Radical-7 Descriptions Functionality of the Radical-7 The Radical-7 provides the functionality of three instruments in one: Handheld Pulse CO-Oximeter The Radical-7 is a fully featured Handheld. The Handheld contains the majority of the device features. All measurements and instrument status datum are displayed on the touchscreen. All user input is performed through the touchscreen and control buttons. The sensor cable connector is located on the Handheld.
Radical-7 Chapter 2: Radical-7 Descriptions Handheld All user input and displays are controlled by this component. The patient cable connects into the connector on the Handheld instrument. The Handheld is battery powered and can be used either as a transport monitor or as a Handheld Pulse CO-Oximeter for spot checks. Handheld Front Panel The following figure numbers and corresponding table describes the hardware features of the Radical-7.
Radical-7 Chapter 2: Radical-7 Descriptions Handheld Back Panel The Handheld back panel features the connection to the Docking Station, an accessory mount for the pole clamp accessory, and access to the Handheld battery pack. Item Description 1 The Handheld interfaces with the Docking Station through this connector. 2 The optional Pole Clamp accessory attaches to this holder. See the directions for use of the Pole Clamp accessory for attachment instructions.
Radical-7 Chapter 2: Radical-7 Descriptions Standalone When the Handheld is placed into the Docking Station, they become a full-featured standalone system. In this manual, when the Handheld and the Docking Station are connected, they are referred to Standalone. The Standalone acts as a battery charger for the Handheld and has AC power connection capabilities. If the AC power from the wall outlet is temporarily interrupted, then the battery in the Handheld allows for continuous operation.
Radical-7 Chapter 2: Radical-7 Descriptions Standalone Front Panel The following figure and corresponding text review the features of the Radical-7 Standalone. Note that when the Standalone is turned on, all indicator LEDs initially turn on and off at start up. Item Description 1 Docking Station The Docking Station Battery Charging Battery Charging indicator is illuminated when the Docking Indicator Station battery is charging. The indicator blinks just prior to charging.
Radical-7 Chapter 2: Radical-7 Descriptions Standalone Back Panel The following figure and corresponding text review the features of the Radical-7 Standalone. Item Connector Description 1 Serial Output connector Use the Serial Output connector with a ferrite bead installed to connect a serial instrument, including a serial printer, a monitoring system or PC to the Radical-7. The data is provided in standard RS-232C format.
Radical-7 Chapter 2: Radical-7 Descriptions Item Connector Description 4 Power Entry module The Power Entry module contains the input connector for AC power and two fuses. The AC input provides power to the system from the AC line. Always connect the Radical-7 to the mains power for continuous operation and/ or battery recharging. Note: Use the power cord as the means to disconnect the instrument from the mains power supply.
Chapter 3: Setup The following chapter contains information about setting up the Radical-7 before use. Unpacking and Inspection To unpack and inspect the device 1. 2. 3. Remove the instrument 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. These may be required to process a claim with the carrier. If anything is missing or damaged, contact the Technical Service Department.
Radical-7 Chapter 3: Setup Initial Battery Charging Before use, the Radical-7 Handheld battery and the Docking Station battery must be charged completely. See Electrical Safety Information, Warnings, and Cautions on page 18. To charge the Handheld and Docking Station for the first time 1. 2. 3. 4. Attach the Handheld to the Docking Station. Plug in the AC power cord to power entry module. Make sure it is securely plugged in. Plug the AC power cord into an AC power source.
Radical-7 Chapter 3: Setup Setting Up for SpaceLabs Flexport To set up for use with SpaceLabs Flexport 1. 2. 3. 4. 5. On the Radical-7, on the device output screen, for the serial option, select SpaceLabs Flexport. Connect one end of the Spacelabs Flexport cable to the Serial Output connector on the Docking Station. Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal Flexport connector. The SpO2 and pulse rate values appear on the Spacelabs screen.
Radical-7 Chapter 3: Setup Setting Up and Using SatShare Parameter values from the Radical-7 can be displayed on a multi-parameter monitor through the SatShare feature. The SatShare feature provides an ideal, simulated plethysmographic waveform that corresponds to the parameter values determined the by Radical-7. This waveform may be used to display these values on multi-parameter monitors through the multi-parameter oximetry sensor or input connector.
Chapter 4: Operation The following chapter contains information about using the Radical-7. Using the Touchscreen and Buttons 1. 2. 3. 4. 5. www.masimo.com 45 Display View To access other screens, touch a value on the Display View. See About the Display View on page 48. Profiles button To the access the Profiles screen, press Profiles. See Chapter 5: Profiles on page 93. Alarm Silence button To temporarily silence audible alarms, press Alarm Silence. See Silencing the Alarms on page 99.
Radical-7 Chapter 4: Operation Using Screen Lock When turned on, the Screen Lock feature may prevent unintentional interaction with Display View. Using the Screen Lock feature 1. 2. 3. When turned on, any interaction with the Display View triggers the Screen Lock feature. To bypass Screen Lock when it appears, press and hold the Lock icon until it unlocks. To turn on or turn off Screen Lock, see Access Control on page 76.
Radical-7 Chapter 4: Operation Navigating the Radical-7 Navigate the Radical-7 screens via the Display View or the Main Menu. Display View The following is the primary interactive screen that the user views. To access the Main Menu screen • Touch the gear icon at the lower right corner of the display. Main Menu The following is the Main Menu screen where users can access additional screens and information. Users can swipe the screen left or right to pan the Menu Icons.
Radical-7 Chapter 4: Operation About the Display View The Display View consists of different areas: Status Bar. See About the Status Bar on page 49. Parameter Display. See Changing the Size of Parameter Values on page 50. Trend Field. See Waveform and Trend Views on page 52. www.masimo.
Radical-7 Chapter 4: Operation Small Parameter View. See Accessing the Main Menu on page 57. About the Status Bar The Status Bar is visible on the top portion of the Display View. Status Bar Access additional screens, more information, or toggle features by touching directly on any of the following indicators in the Status Bar. • Sensitivity Modes. See Sensitivity Modes Overview on page 55. • Profiles. See Profiles Overview on page 93. • Messages on page 104. (read only) • WiFi on page 79.
Radical-7 Chapter 4: Operation Changing the Size of Parameter Values To change the size of parameter values on the Display View 1. 2. 3. 4. On the Small Parameter view, touch and hold any one of the parameters, as shown above. When the parameter value dims, shakes, and grows in size, drag and drop that parameter above the Trend Field. The parameter value appears on the screen in a larger font. The device automatically configures the screen for optimal display of the parameter values.
Radical-7 Chapter 4: Operation Trend Field The Trend Field allows users to access various customizable views. See Trends on page 81. To access trend, waveform, or customize the views on the Display View screen 1. Touch the Trend Field, as shown below. 2. The following screen appears. www.masimo.
Radical-7 3. 4. 5. Chapter 4: Operation Swipe up or swipe down the available options. Touch on the desired option. The Trend Field displays trend data specific to the option that was selected. Pulse Bar The Pulse Bar is a visual indicator that conveys the detection of pulse and the Signal IQ (SIQ) displayed on each individual pulsation. The height of the bars provides an assessment of the confidence in the measurement displayed. See Signal IQ Indicators on page 53.
Radical-7 Chapter 4: Operation Pleth + Sig IQ View Shows the parameter values on the top of the screen. The waveform is located below the parameter values. The Small Parameter view is located along the bottom of the screen. This view contains the Pleth Waveform with signal quality indications only. Signal IQ Indicators The Signal IQ (SIQ), displayed on each individual pulsation, is conveyed by vertical bars, as shown below.
Radical-7 Chapter 4: Operation Acoustic Waveform View Shows the parameter values on the top of the screen. The RRa waveform is located below the parameter values. The Small Parameter view is located along the bottom of the screen. Acoustic Respiratory Rate (RRa) must be available for this feature to be shown. This view contains acoustic respiratory rate waveform only. Pleth + Sig IQ + Acoustic View Shows the parameter values on the top of the screen. The waveform is located below the parameter values.
Radical-7 Chapter 4: Operation Parameter Quick Trend View This view displays the quick trend of the selected parameter over an adjustable period of time. The default is 1 hour. Enlarge the quick trend to the full trend view by touching the expand icon of the waveform display. With a pinch gesture, using two fingers, the user can zoom in and out of the quick trend data within the Trend Field.
Radical-7 Chapter 4: Operation Changing Sensitivity Modes There are two ways to change the sensitivity modes. 1. Press the indication on the top left of the Display View. 2. Alternatively, from the Main Menu, touch the Profiles icon. From the Profiles screen, select the desired mode by scrolling up or down. Then select OK. Note that the device will revert to APOD mode after a power cycle. See Changing Profiles on page 94. www.masimo.
Radical-7 Chapter 4: Operation Accessing the Main Menu To access Main Menu from the Display View, touch the gear icon on the bottom right corner of the Small Parameter View. Navigating the Main Menu • From the Main Menu screen, touch the icons for any of the following screens: Device Settings See Device Settings on page 75. www.masimo.
Radical-7 Chapter 4: Operation Parameter Settings See Parameter Settings on page 59. Profiles See Changing Profiles on page 94. 3D Alarms See 3D Alarms on page 102. Trends See Trends on page 81 and Trend Field on page 51. Sound See Sounds on page 74. About See About on page 91. www.masimo.
Radical-7 Chapter 4: Operation Parameter Settings The following is an example of the Parameter Settings screen. Only parameters that have been loaded onto the system will be visible. To access any of the available parameter setting screens 1. 2. From the Parameter Settings screen, to access the desired parameter, flick the on-screen icons left or right. Touch the icon of the desired parameter. For details, see any of the following sections. SpO2 Settings on page 62. SpHb Settings on page 63.
Radical-7 Chapter 4: Operation About Parameter Information Additional information about each parameter is available. To access additional information about parameters 1. From the parameter settings screen, touch the About icon. The following is an example for SpHb. 2. An About screen appears for the selected parameter. www.masimo.
Radical-7 Chapter 4: Operation In Vivo Adjustment Overview The In Vivo Adjustment feature lets clinicians manually adjust one or more clinical parameters to match that of a corresponding laboratory reference for continuous trending. To remind clinicians that the feature is active, an offset value displays alongside the adjusted parameter value.
Radical-7 Chapter 4: Operation SpO2 Settings Access any of the following options: Alarms for SpO2. Additional Settings for SpO2 on page 63. About Parameter Information on page 60. Alarms for SpO2 From the Alarms screen, change any of the following options: Factory Default Settings Options Description High Limit High Limit is the upper threshold that triggers an alarm. Off Low Limit Low Limit is the lower threshold that triggers an alarm.
Radical-7 Chapter 4: Operation Additional Settings for SpO2 From the Additional Settings screen, change any of the following options: Options Description Factory Default Settings Averaging Time The length of time over which the 8 seconds system calculates the average of all data points. FastSat See FastSat Overview on page 63. User Configurable Settings 2-4, 4-6, 8, 10, 12, 14, or 16 seconds Off On or Off FastSat Overview FastSat enables rapid tracking of arterial oxygen saturation changes.
Radical-7 Chapter 4: Operation SpHb Alarms From the Alarms screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings High Limit The High Limit is upper threshold that triggers an alarm. 17.0 g/dL 2.0 g/dL to 24.5 g/dL in steps of 0.1 g/dL, or Off (11.0 mmol/L) (2.0 mmol/L to 15.0 mmol/L in steps of 0.1 mmol/L, or Off) When SpHb Precision is set to 1.0, the values are rounded down. When set to Off, alarm is disabled.
Radical-7 Chapter 4: Operation Unit of Measure Displays total hemoglobin (SpHb) as g/dL (grams per deciliter) or mmol/L (milimoles per liter). g/dL mmol/L or g/dL In Vivo for SpHb From the In Vivo screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings In Vivo Calibration See In Vivo Adjustment Overview on page 61. Off On or Off In Vivo Calibration Offset See In Vivo Adjustment Overview on page 61. 0 ± 3 g/dL in steps of ± 0.
Radical-7 Chapter 4: Operation Perfusion Index (PI) Settings From the PI Settings screen, access any of the following screens: PI Alarms on page 66. Additional Settings for PI on page 66. About Parameter Information on page 60. PI Alarms From the Alarms screen, change any of the following options: Options Description Factory Default Settings High Limit The High Limit is upper Off threshold that triggers an alarm. User Configurable Settings Step size: 0.04 to 0.09 in steps of 0.01 0.10 to 0.
Radical-7 Chapter 4: Operation Respiration Rate (RR) The Radical-7 can determine respiration rate (RR) either by the acoustic signal (RRa) or by the plethysmographic waveform (RRp). RRp Settings When using a pulse oximetry or pulse CO-Oximetry sensor with the Radical-7, respiration rate can be determined by the plethysmographic waveform (RRp). This method measures a patient's respiratory rate based on plethysmographic amplitude changes that correspond to the respiratory cycle.
Radical-7 Chapter 4: Operation Options Description Factory Default Configurable Options High Limit The High Limit is upper threshold that triggers an alarm. 30 breaths per minute 6 breaths per minute to 69 breaths per minute, or Off Low Limit The Low Limit is lower 6 breaths per threshold that minute triggers an alarm. 5 breaths per minute to 68 breaths per minute, or Off Alarm Delay When an alarm condition is met, this feature delays the audible part of an alarm.
Radical-7 Chapter 4: Operation RRa Settings RRa is active under the following conditions: • RRa is installed on the Radical-7. • Dual Rainbow cable is connected. • Acoustic sensor is connected. From the RR Settings screen, access any of the following screens: RRa Alarms on page 69. Additional Settings for RRa on page 70. About Parameter Information on page 60.
Radical-7 Chapter 4: Operation Additional Settings for RRa From the Additional Settings screen, change any of the following options: Options Description Factory Default Settings Averaging Time The length of time Slow over which the system calculates the average of all data points. Trending, No, Fast, Medium, or Slow Freshness The duration of time that, during interference, the system displays the last valid reading.
Radical-7 Chapter 4: Operation Additional Settings for PVI From the Additional Settings screen, change any of the following options: Options Description Factory Default Settings Averaging Time The length of time Long over which the system calculates the average of all data points. User Configurable Settings Short or Long SpCO Settings From the SpCO Settings screen, access the following screens: SpCO Alarms on page 71. About Parameter Information on page 60.
Radical-7 Chapter 4: Operation In Vivo for SpCO From the In Vivo screen, access the following screens: Options Description Factory Default Settings User Configurable Settings Enabled See In Vivo Adjustment Overview on page 61. Off On or Off 0 ± 9% in steps of 0.1% Offset Amount See In Vivo Adjustment Overview on page 61. SpMet Settings From the SpMet Settings screen, access the following screens: SpMet Alarms on page 72. About Parameter Information on page 60.
Radical-7 Chapter 4: Operation In Vivo for SpMet From the In Vivo screen, access the following screens: Options Description Factory Default Settings User Configurable Settings Enabled Match the corresponding laboratory reference for continuous trending. Off On or Off Offset Amount Helps offset individual 0 patient bias that is expected when comparing a noninvasive measurement to a laboratory reference. ±3% in steps of 0.
Radical-7 Chapter 4: Operation Sounds From the Sounds screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings Alarm Volume Sets the alarm Level 4 volume and provides a sample of the alarm volume. Level 1 to 4 Pulse Tone Volume Sets the volume of Level 3 the tone that conveys the pulse rate. Off, Level 1 to 4 Silence Duration Length of time that the audible alarm remains muted.
Radical-7 Chapter 4: Operation Device Settings The following is an example of the Device Settings screen. From the Device Settings screen, access any of the following options: Screen Orientation on page 79. Localization on page 78. WiFi on page 79. Battery on page 80. Brightness on page 80. Access Control on page 76. Device Output on page 80. www.masimo.
Radical-7 Chapter 4: Operation Access Control The Access Control screen is protected by a Password screen. Password Screen Using the Password screen 2. On the Password screen, enter the following numbers: 6 2 7 4 No numbers will be displayed, only asterisks (****). Touch Enter. 3. To undo numbers, touch Backspace. 1. www.masimo.
Radical-7 Chapter 4: Operation Access Control Screen From the Access Control screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings All Mute All patient alarm conditions are silenced. Only system alarms will be indicated by an audible alarm. Disabled Enabled or disabled If enabled, All Mute and All Mute with Reminder become available settings from the Silence Duration option on the Sounds screen. See Sounds on page 74.
Radical-7 Chapter 4: Operation Factory Defaults Press Restore to return to factory default values. Options are restored N/A to factory values. Localization From the Localization screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings Current Date Date N/A N/A Current Time Time N/A N/A Language Language in which the screens display. English Choose from available languages.
Radical-7 Chapter 4: Operation Screen Orientation From the Screen Orientation screen, change any of the following options: Options Description Factory Default User Configurable Settings Settings Auto Orientation Allows the device to On automatically adjust the Display screens depending on orientation. Off or On Orientation Landscape: rotates the screen to horizontal viewing position Rotates the viewing screens depending on device orientation.
Radical-7 Chapter 4: Operation Battery From the Battery screen, view the following information: • Battery icon that conveys remaining battery charge as a green color. • Battery icon that conveys that battery charging status. See About the Status Bar on page 49. See Battery Operation and Maintenance on page 131.
Radical-7 Analog 2 Chapter 4: Operation Depending on the configuration, the following parameters are output continuously on the Analog 1 and Analog 2. N/A Pleth, SIQ, 0V Output, 1V Output, SpO2 0% to 100%, SpO2 50% to 100%, or Pulse rate Nurse Call Trigger The nurse call output will be N/A activated based on the alarm events. The nurse call with be activated based on Low Signal or Alarm and Low Signal IQ events.
Radical-7 Chapter 4: Operation The following is an example of trend information for SpO2 as it appears in the Full Trend screen. Changing Between Trend Views To toggle between Display View and Full Trend From the Display View, in the Trend Field, touch the icon as shown below. From the Full Trend screen, touch the icon as shown below. www.masimo.
Radical-7 www.masimo.
Radical-7 Chapter 4: Operation Manipulating Trend Data To manipulate the view of trend data On the Full Trend screen, with a pinch gesture, using two fingers, the user can zoom in and out of the trend time scale. The user can add parameters to the Trend view by dragging and dropping parameters from the Small Parameter view. To add a parameter to the Trend view, press and hold any of the parameters inside the Small Parameter view, as shown below.
Radical-7 Chapter 4: Operation To view past patient trend data, swipe the trend display to the left or to the right. To exit a Trend view, press the Home button. Changing the Time Interval of Trend Data Users can change the time interval of trend data. The time options that can be selected are 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, or 24 hours. To change the time interval of trend data 1.
Radical-7 2. Chapter 4: Operation Scroll up or down to select a time interval. Using the Histogram Feature Users can view trend data using the Histogram feature. When turned on, the Histogram feature displays trend data as a histogram. To turn on the Histogram feature 1. 2. Navigate to a Full Trend screen. See Changing Between Trend Views on page 82. The Histogram icon appears along the top of the Trend Field, as shown in the following example for SpO2. www.masimo.
Radical-7 3. 4. Chapter 4: Operation Touch the Histogram icon. Trend data displays as a histogram. To turn off the Histogram feature • Touch the Trends icon, as shown. www.masimo.
Radical-7 Chapter 4: Operation Changing Trend Settings There are several ways to access and then change the maximum value and the minimum value of the Y axis for any of the available parameters. To access the trend settings for any of the available parameters 1. 2. From the Main Menu screen, touch the Trends icon. From the Trends screen, touch any of the available parameters. Alternatively, from any Parameter Settings screen, touch the Trends icon. www.masimo.
Radical-7 Chapter 4: Operation Alternatively, from the Display View or from the Full Trend view, touch the Y axis range on the left side of the screen as shown. When viewing trends for an additional parameter, the Y axis range appears on the right side of the screen. To change the trend settings for any of the available parameters 1. Touch the slider for the Y-axis maximum or the Y-axis minimum.The following is an example of the SpO2 Trend screen. 2. Select the desired setting by scrolling up or down.
Radical-7 Chapter 4: Operation Deleting Trend Data The user can delete patient trend data that has been stored on the Radical-7. To delete patient trend data 1. From the Trends screen, touch the Trend Settings icon. 2. From the Trend Settings screen, touch Clear, and then touch OK. This deletes all stored trend data. www.masimo.
Radical-7 Chapter 4: Operation About For information about parameters, see About Parameter Information on page 60. From the About screen, view any of the following options: Options Description Serial Number Displays the serial number of the Handheld. MCU Displays the version number of the instrument board software. MX Board Displays the version number of the technology level software. Processor Displays the version number of the system level software.
Chapter 5: Profiles The Radical-7 can be configured for various patient types. Profiles Overview The Radical-7 contains a Profiles screen, which lets the user customize different settings for different patient populations: • Adult Adult profile is the factory default profile. Displays in the Status bar as ADULT and the color of the Profile button turns blue. • Neonatal Displays in the Status bar as NEO and the color of the Profile button turns pink.
Radical-7 Chapter 5: Profiles The Radical-7 conveys the active profile by changing the color of the Profiles button. To restore all Radical-7 settings to factory default settings, see Access Control on page 76. Changing Profiles Changing Profiles is done in the Profiles Settings screen. There are different ways to access the Profiles Settings screen. • The first way is by the touching the Profiles shortcut in the Status Bar, as show below.
Radical-7 • Chapter 5: Profiles Alternatively, from the Main Menu screen, touch the Profiles icon. www.masimo.
Radical-7 Chapter 5: Profiles To change Patient Type 1. From the Profile screen, touch the Patient Type field. 2. Select the desired Patient Type by scrolling up or down. 3. When finished, touch OK. To confirm selection, check the Status Bar. From the Profiles screen, change any of the following options: Options Description Patient Type Defines the patient population Adult for which the device will operate.
Radical-7 Chapter 5: Profiles Silence Duration The amount of time for which the 120 audible part of an alarm will be silenced. See Silencing the Alarms on page 99. 30, 60, 90, 120 seconds Smart Tone Allows the audible pulse to Off continue to beep when the pleth graph shows signs of motion.
Radical-7 Chapter 5: Profiles Powering Off the Radical-7 When turning off the Radical-7, the device remembers the preferred settings. To turn off the Radical-7 1. Press and hold the button for more than 2 seconds. 2. To confirm the shutdown process, the following screen appears. www.masimo.
Chapter 6: Alarms and Messages The following chapter contains information about alarms and messages. For more information, see Chapter 7: Troubleshooting on page 111. About Alarms The Radical-7 visually and audibly indicates alarm conditions that the system detects. Audible alarms may be silenced, without affecting the operation of visual alarms. See Safety Information, Warnings, and Cautions on page 11 and Alarm Related Safety Information, Warnings, and Cautions on page 20.
Radical-7 Chapter 6: Alarms and Messages The following is an example of a typical alarm due to parameter limit violation. To silence or dismiss alarms: • Touch Silence (the highlighted area of the Status Bar). Audible alarms can be temporarily suspended by pressing the Alarm Silence button. When alarms are in the suspend state, pressing the Alarm Silence button cancels the alarm suspend. To silence audible alarms 1. When an audible is active, push Alarm Silence one time. 2.
Radical-7 Chapter 6: Alarms and Messages Adaptive Threshold Alarm (ATA) Feature The Adaptive Threshold Alarm (ATA) feature is an optional feature that provides continuous SpO2 surveillance while allowing the clinician a useful tool to help reduce the frequency of audible alarms. ATA establishes the alarm limit threshold based upon the patient-specific baseline value of the SpO2 parameter which is determined from the recent history of SpO2 values.
Radical-7 Chapter 6: Alarms and Messages 3D Alarms 3D Alarms include the Desat Index Alarm and the PI Delta Alarm. Desat Index Alarm Overview on page 102. Perfusion Index (PI) Delta Alarm Overview on page 103. Desat Index Alarm Overview The Desat Index Alarm is a user-selectable feature which allows a clinician to request an audible and visual alarm if a patient experiences a specified number of desaturations over a specific period of time.
Radical-7 Chapter 6: Alarms and Messages Desat Index Alarms From the Alarms screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings Delta See Desat Index Alarm Overview on page 102. 4% 2% to 10% in steps of 1%. Time See Desat Index Alarm Overview on page 102. 1 hour 1 to 4 hours, in steps of 1. Off Off, 1 to 24 desaturations in steps of 1. # of Events See Desat Index Alarm Overview on page 102.
Radical-7 Chapter 6: Alarms and Messages PI Delta Alarms From the Alarms screen, change any of the following options: Options Description Factory Default Settings User Configurable Settings Set Baseline See Perfusion Index (PI) Delta Alarm Overview on page 103. Off On or Off Baseline See Perfusion Index (PI) Delta Alarm Overview on page 103. Off, or PI baseline N/A Percent Change See Perfusion Index (PI) Delta Alarm Overview on page 103.
Radical-7 Chapter 6: Alarms and Messages Replace Cable Message Message: • (Pulse CO-Ox) Replace Cable, or • (RAM) Replace Cable The patient cable is non-functional or the life of the cable has expired. Next steps: Replace the patient cable.
Radical-7 Chapter 6: Alarms and Messages No Adhesive Sensor Connected Message Message: • (Pulse CO-Ox) No Adhesive Sensor Connected, or • (RAM) No Adhesive Sensor Connected When a single-patient-use sensor is used, the adhesive portion of the sensor is not connected. (Applies to Rainbow ReSposable CO-Oximeter Sensor Systems or ReSposable Pulse CO-Oximeter Sensor Systems only.) Next steps: Ensure the adhesive portion is firmly connected to the sensor.
Radical-7 Chapter 6: Alarms and Messages Low Signal IQ Message Message: (Pulse CO-Ox) Low Signal IQ Low signal quality. Next steps: Ensure proper sensor application. Move sensor to a better perfused site. See Signal IQ (SIQ) on page 111. Low SpCO SIQ Message SpCO measurement reading is obscured. Next steps: Ensure proper sensor application. Check sensor to see if it is working properly. If not, replace the sensor. See Successful Monitoring for SpCO on page 28.
Radical-7 Chapter 6: Alarms and Messages No Sensor Connected Message Message: • (Pulse CO-Ox) No Sensor Connected, or • (RAM) No Sensor Connected Sensor not fully inserted into the connector. May be an incorrect sensor or a defective sensor or cable. Next steps: Disconnect and reconnect sensor. See the instructions for use provided with your sensor. Instrument is searching for patient’s pulse. Next steps: Disconnect and reconnect the sensor into the Patient Cable connector.
Radical-7 Chapter 6: Alarms and Messages Incompatible Cable Message Message: (Pulse CO-Ox) Incompatible Cable Not a proper cable. Next steps: Replace with a proper cable. www.masimo.
Chapter 7: Troubleshooting The following chapter contains information about troubleshooting the Radical-7 system. Troubleshooting Measurements See Parameter Related Safety Information, Warnings, and Cautions on page 11. Signal IQ (SIQ) The Signal IQ provides an indicator of the assessment of the confidence in the displayed SpO2 value. The SpO2 SIQ can be also used to identify the occurrence of a patient’s pulse. With motion, the plethysmographic waveform is often distorted and may be obscured by artifact.
Radical-7 Chapter 7: Troubleshooting Dimly Lit Parameters When the signal quality is very low, the accuracy of measurements may be compromised, the parameter may be dimly lit, and the parameter may display dashes instead of a numeric value.
Radical-7 Chapter 7: Troubleshooting Unexpectedly High SpCO Reading Possible elevated methemoglobin level. Next steps: Submit blood sample for laboratory CO-Oximetry test. See Appendix: Best Practices for Comparisons to Reference Measurements on page 139. Difficulty Obtaining a Reading • Low battery/ not plugged into AC power supply. Next steps: Insert Handheld into Docking Station, verify Docking Station power cord plugged in and Docking Station power indicator light is illuminated.
Radical-7 Chapter 7: Troubleshooting Continuous Speaker Tone Internal failure. Next steps: To silence an alarm, press the Alarm Silence button. If alarm continues to sound, turn off the Radical-7. If necessary, remove Handheld battery. Requires service. See Contacting Masimo on page 136. Buttons Do Not Work When Pressed Internal failure. Next steps: Requires service. See Contacting Masimo on page 136. Handheld Battery Does Not Charge AC power cable may be disconnected.
Chapter 8: Specifications The following chapter contains specifications for the Radical-7 Handheld, compatible Docking Stations, and the Standalone system. Measurement Range Measurement Display Range SpO2 (Oxygen Saturation) 0% to 100% SpMet (Methemoglobin) 0% to 99.9% SpCO (Carboxyhemoglobin) 0% to 99% SpHb (Hemoglobin) 0 g/dL to 25.0 g/dL SpOC (Oxygen Content) 0 ml of O2/dL to 35 ml of O2/dL of blood PR (Pulse Rate) 25 bpm to 240 bpm PI (Perfusion Index) 0.
Radical-7 Chapter 8: Specifications No Motion [2] 70% to 100% Adults, Infants, Pediatrics ± 2% Neonates ± 3% Motion [3] 70% to 100% Adults, Infants, Pediatrics, Neonates ± 3% Low Perfusion [4] Adults, Infants, Pediatrics, Neonates ± 2% Pulse Rate Accuracy Pulse rate range 25 bpm to 240 bpm No Motion Adults, infants, pediatrics, neonates ± 3 bpm Motion [4] Adults, infants, pediatrics, neonates ± 5 bpm Low Perfusion Adults, infants, pediatrics, neonates ± 3 bpm Carboxyhemoglobin Accuracy
Radical-7 Chapter 8: Specifications Respiratory Rate Accuracy (RRa) [11] Adults, pediatrics 0 breaths per minute to 70 breaths per minute, ±1 breath per minute Respiratory Rate Accuracy (RRp) [11] Adults, pediatrics 0 breaths per minute to 70 breaths per minute, ±1 breath per minute Resolution Parameter Step Size %SpO2 1% %SpCO 1% %SpMet 0.1% SpHb g/dL 0.
Radical-7 Chapter 8: Specifications Capacity 4 hours [7] Time 3 hours Environmental Operating Temperature 32°F to 122°F (0°C to 50°C) Transport/Storage Temperature -40°F to 158°F (-40°C to 70°C) [8] Operating Humidity 10% to 95%, non-condensing Operating Altitude 500 mbar to 1060 mbar -1000 ft to 18,000 ft (-304 m to 5,486 m) Physical Characteristics Dimensions Handheld 8.9” x 3.5” x 2.1” (22.6 cm x 8.9cm x 5.3 cm) Standalone 3.5” x 10.5” x 7.7” (8.9 cm x 26.7 cm x 19.
Radical-7 Chapter 8: Specifications Alarms Parameter Alarm Range SpO2 1% to 99% SpCO 1% to 98% SpMet 0.1% to 99.5% SpHb 1.0 g/dL to 24.5 g/dL RR 5 breaths per minute to 69 breaths per minute PI 0.03% to 19% PVI 1% to 99% Pulse Rate 30 bpm to 235 bpm SpOC 1 g/dL to 34 g/dL Sensor condition, system failure, and low battery alarms High Priority 571 Hz tone, 5-pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.
Radical-7 Chapter 8: Specifications Display Indicators Display Update Rate 1 second Response Time < 20 second delay Type Backlit Active Matrix TFT LCD Pixels 480 dots x 272 dots Dot Pitch 0.25 mm www.masimo.
Radical-7 Chapter 8: Specifications Compliance EMC Compliance • EN55011: Radiated Emissions (CISPRR 11, 2009 Amendment A1:2010, Class B) • EN55011: Conducted Emissions (CISPRR 11, 2009 Amendment A1:2010, Class B) • EN301 489-17: Radiated Emissions (EN 301 489-01 V1.8.1:2008, Class B) • EN301 489-17: Conducted Emissions (EN 301 489-01 V1.8.
Radical-7 Chapter 8: Specifications Degree of Protection-Patient Cable Type BF-Applied Part Degree of Protection-SatShare Cable Type CF-Applied Part Mode of Operation Continuous Output Interface SatShare (RDS-1). See Serial Interface Specifications on page 122. Serial RS-232 (RDS-1, RDS-3) Nurse Call/Analog Output (RDS-1, RDS-3) VueLink, (Philips, Agilent, HP, Spacelabs Flexport, RadNet, SafetyNet (RDS-1, RDS-3) Wireless Radio (If Installed) Radio Modes 802.
Radical-7 Chapter 8: Specifications selects a different output mode. To interface with the Radical-7 and receive serial text data, connect a serial interface cable with a ferrite bead installed to the serial output connector located on the back of the Radical-7 Docking Station. The Radical-7 serial interface is only available when the Radical-7 Handheld is properly attached to the Docking Station. Once serial communication is established, packets of data are communicated at 1 second intervals.
Radical-7 Chapter 8: Specifications Pin Signal name 8 No Connection 9 No Connection Analog Output and Nurse Call Specifications Analog Out and Nurse Call are accessible on the same female high-density DB-15 connector. Analog Output and Nurse Call interface are only available when the Handheld is attached to the Docking Station. Only use an Analog and Nurse Call cable that has a ferrite bead installed. Analog Output and Nurse Call interface is not available in all versions of the Docking Station.
Radical-7 Chapter 8: Specifications Pin Signal Name 15 Analog 2 Analog Output The Radical-7 Pulse CO-Oximeter can interface with various analog recording instruments or strip chart recorders through its Analog Output connector located on the back of the Docking Station. The output signals vary from approximately 0 to 1 volt in a linear fashion. The actual analog output voltage generated may not exactly range between 0.0V to 1.0V. A variance of ± 40 mV is acceptable.
Radical-7 Chapter 8: Specifications Symbols The following symbols are found on the Radical-7, Docking Station, or packaging and are defined below. Some of the interfaces and symbols are not available on all versions of the Docking Station. Symbols www.masimo.
Radical-7 Chapter 8: Specifications Mark of conformity to European Medical Instrument Directive 93/42/EEC Caution Federal law restricts this device to sale by or on the order of a physician (USA FDA) Name of Manufacturer Underwriter's Laboratories Inc.
Radical-7 Chapter 8: Specifications Ghana GH Greece GR Guatemala GT Honduras HN Hong Kong HK Hungary HU India IN Iraq IQ Israel IL Italy IT Jordan JO Kazakhstan KZ Kenya KE Kuwait KW Laos LA Lebanon LB Libya LY Malta MT Mauritius MU Monaco MC Morocco MA Mozambique MZ Netherlands NL New Caledonia NC Nigeria NG Norway NO Oman OM Palestinian Territory PS Panama PA Papua New Guinea PG Peru PE Philippines PH Poland PL Portugal PT Puerto Rico P
Radical-7 Chapter 8: Specifications Citations [1] SpO2, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% to 100% SpO2, 0% to 40% SpCO, and 0% to 15% SpMet against a laboratory CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7 days to 135 days old and weighting between 0.5 kgs and 4.25 kgs. Seventy-nine (79) data samples were collected over a range of 70% to 100% SaO2 and 0.5% to 2.
Chapter 9: Service and Maintenance The following chapter contains information about cleaning, battery operation, performance verification, service, repair, and warranty. Cleaning Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations. Safety Information, Warnings, and Cautions on page 11.
Radical-7 Chapter 9: Service and Maintenance indicator continuously flashes. When the temperature returns to recommended operating conditions, proper battery charging proceeds. • The Handheld battery requires approximately 4 hours for charging. The Docking Station battery requires approximately 6 hours for charging. • When both the Handheld Battery Charging indicator and the Docking Station Battery Charging indicator turn off, additional trickle charging may occur to complete charging.
Radical-7 Chapter 9: Service and Maintenance Replacing the Batteries Before installing or removing the battery, make sure the AC power cord is removed and power to the Radical-7 is turned off. To replace the rechargeable Handheld battery 1. 2. 3. 4. 5. Turn off the Radical-7 Handheld off and remove the patient cable connection. If docked, detach the Handheld from the Docking Station. Loosen the closure screw on the battery compartment door and lift out the battery.
Radical-7 Chapter 9: Service and Maintenance Performance Verification Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local and governmental regulations. To test the performance of the Radical-7 following repairs or during routine maintenance, follow the procedure outlined in this chapter.
Radical-7 Chapter 9: Service and Maintenance Nurse Call Test To conduct a Nurse Call test 1. 2. 3. 4. 5. Disconnect any patient cables, sensors, or accessories from the Radical-7. Turn off the Radical-7 and then turn on again. Ensure that there are no audible alarms and that the Audible Alarm feature is not set to silenced. Verify the Nurse Call polarity is set to normal (default).
Radical-7 Chapter 9: Service and Maintenance Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the instrument repaired. Clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in Cleaning. Make sure the equipment is fully dry before packing. To return the instrument for service, see Return Procedure on page 136.
Radical-7 Chapter 9: Service and Maintenance Warranty Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: (i) each new Product and the Software media as delivered are free from defects in workmanship or materials, and (ii) the Product and Software will perform substantially as labeled in the directions for use. Masimo’s sole obligation under this warranty is to repair or replace any Product or Software that is covered under warranty.
Radical-7 Chapter 9: Service and Maintenance Restrictions 1. 2. 3. 4. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchaser’s failure to abide by the terms of this Agreement.
Appendix: Best Practices for Comparisons to Reference Measurements Best Practices Checklist for Continuous SpHb Comparisons Ensure SpHb device is turned on. If applicable, connect to computer with automatic data capture. Sensor site selection: • Remove anything from patient's arm that can impede blood flow to the sensor site, such as restrictive garments, accessories, purses, backpacks, watches, jewelry, and blood pressure cuff.
Radical-7 Appendix: Best Practices for Comparisons to Reference Measurements • Align upper and lower red lines. • If using a reusable sensor, make sure finger tip is inserted all the way and touching the finger stop inside the sensor (allowing long finger nails to extend beyond the finger stop). • Ensure cable runs flat over the top of the hand directly in the middle of the finger with no kinks or twists so the cable does not pull on the sensor.
Radical-7 Appendix: Best Practices for Comparisons to Reference Measurements • Secure sensor cable to patient’s arm with tape. • Instruct subjects to remain still without any sensor movement. • Connect sensor cable to device without pulling on sensor. • Wait until SpHb measurement is stable (one minute) before recording SpHb values. • Note any Low SIQ message that displays during measurement. Blood sampling and laboratory analysis: • Record site of blood draw.
Radical-7 Appendix: Best Practices for Comparisons to Reference Measurements Best Practices Checklist for SpCO Comparisons Ensure SpCO device is powered on and connected to computer with automatic data capture. After venous blood draw, SpCO testing must be initiated within 30 seconds (COHb can change rapidly).
Radical-7 Appendix: Best Practices for Comparisons to Reference Measurements • Ensure cable runs flat over the top of the hand directly in the middle of the finger with no kinks or twists so the cable does not pull on the sensor. • Cover sensor with Masimo-provided shielding to avoid light interference. • Secure sensor cable to patient’s arm with tape. • Instruct subjects to remain still without any sensor movement. • Connect sensor cable to device without pulling on sensor.
Radical-7 Appendix: Best Practices for Comparisons to Reference Measurements Best Practices Checklist for Acoustic Respiration Rate Comparisons Acoustic Sensor placement The Acoustic sensor has a small black arrow on the front (item 1 in figure below), when placing the sensor the black arrow should point forward to the anterior of subject’s body. Ensure placement site is hair-free, clean of debris, and dry prior to sensor placement. Use an alcohol swab to clean the neck area, if needed.
Radical-7 Appendix: Best Practices for Comparisons to Reference Measurements For pediatric subjects that have limited neck space, the sensor may be placed on the right side of chest, underneath clavicle. The sensor should not be touching the clavicle. Place sensor tape on skin. Gently press on sensor tape from center outward so adhesive forms a good contact with patient's skin. Ensure there are no skin folds or air gaps under sensor pad.
Radical-7 Appendix: Best Practices for Comparisons to Reference Measurements Adjust respiratory pause settings as necessary, default is 30 seconds (options are: 15, 20, 25, 30, 35, or 40 seconds). Document patient events and time of event (based on computer clock).
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Best Practices for Comparisons to Reference Measurements • 112, 113, 139 Index 3 B 3D Alarms • 58, 102 Battery • 49, 75, 80 Battery Operation and Maintenance • 36, 42, 44, 80, 114, 131, 133 Battery Run Time Significantly Reduced • 114 Battery Test • 135 Best Practices Checklist for Acoustic Respiration Rate Comparisons • 144 Best Practices Checklist for Continuous SpHb Comparisons • 139 Best Practices Checklist for SpCO Comparisons • 142 Brightness • 75, 80, 113, 132 Buttons Do Not Work When Pressed • 1
Radical-7 Index Functional Oxygen Saturation • 24 Functionality of the Radical-7 • 34 Troubleshooting • 99, 111 Chapter 8 Specifications • 115 G Chapter 9 Service and Maintenance • 107, 131 General Description for Carboxyhemoglobin (SpCO) • 28 General Description for Methemoglobin (SpMet) • 28 General Description for Oxygen Saturation (SpO2) • 24 General Description for Perfusion Index (PI) • 25 General Description for Pleth Variability Index (PVI) • 25 General Description for Pulse Rate (PR) • 25 Gen
Radical-7 Index O Indicators on Docking Station Continuously Flash • 114 Initial Battery Charging • 42 Instrument Does Not Turn On • 113 Instrument Turns On But Screen is Blank • 113 Interference Detected Message • 106 Output Interface • 122 P Parameter Quick Trend View • 55 Parameter Related Safety Information, Warnings, and Cautions • 11, 111 Parameter Settings • 58, 59 Patient • 30 Performance Verification • 134 Perfusion Index (PI) Delta Alarm Overview • 102, 103, 104 Perfusion Index (PI) Settings
Radical-7 Index Signal Extraction Technology (SET) • 23 Signal IQ (SIQ) • 107, 111 Signal IQ Indicators • 52, 53 Signal Processing • 31 Silencing the Alarms • 35, 45, 97, 99 Sounds • 49, 58, 74, 77, 100 SpCO Alarms • 71 SpCO Reading Displays as Dashes • 113 SpCO Settings • 59, 71 SpCO, SpMet, and SpHb Measurements During Patient Motion • 29 Speaker Failure Message • 107 SpHb Alarms • 63, 64 SpHb Settings • 59, 63 SpMet Alarms • 72 SpMet Settings • 59, 72 SpO2 Only Mode Message • 106 SpO2 Settings • 59, 62
Radical-7 Index Troubleshooting the Radical-7 • 113 U Unexpected SpO2, SpCO, SpMet, or SpHb Reading • 112 Unexpectedly High SpCO Reading • 113 Unpacking and Inspection • 41 Using Screen Lock • 46 Using the Histogram Feature • 86 Using the Home Button • 46 Using the Touchscreen and Buttons • 45 W Warranty • 137 Waveform and Trend Views • 48, 52 WiFi • 49, 75, 79 Wireless Radio (If Installed) • 122 www.masimo.
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