Radical-7 Operator's Manual
This Operator’s Manual presents Masimo features and/or products that are marketed outside of the United States (OUS). It is not intended for use in the United States. These operating instructions provide the necessary information for proper operation of all models of the Radical-7® Pulse CO-Oximeter®. There may be information provided in this manual that is not relevant for your system.
EU authorized representative for Masimo Corporation: MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany Authorized Brazil Company Representative: MEDSTAR IMPORT AND EXPORT EIRELI R VALENCIO SOARES RODRIGUES, 89- ROOM 1 CEP: 06.730-000 NEIGHBORHOOD: CENTER MUNICIPALITY: VARGEM GRANDE PAULISTA UF: SP Medical electrical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1 Patents: www.masimo.com/patents.
© 20182019 Masimo Corporation www.masimo.
Contents About this Manual --------------------------------------------------------- 11 Product Description ------------------------------------------------------- 11 Key Features ------------------------------------------------------------ 12 Indications for Use -------------------------------------------------------- 13 Contraindications ---------------------------------------------------------- 14 Warnings and Cautions---------------------------------------------------- 15 Safety Warnings and Cautions --
Radical-7 Contents Chapter 3: Setup ---------------------------------------------------------- 59 Unpacking and Inspection ---------------------------------------------- 59 Docking Station Power Requirements ---------------------------------- 59 Setting Up the Docking Station ---------------------------------------- 60 Initial Battery Charging ------------------------------------------------- 60 Setting Up for Philips, Agilent, or HP VueLink ------------------------- 61 Setting Up for SpaceLabs Flexport -
Radical-7 Contents Profiles Overview------------------------------------------------------ 145 Changing Profiles ----------------------------------------------------- 146 Replacing Factory Default Settings for Adult and Neo Profiles ------ 150 Powering Off the Radical-7 ------------------------------------------- 151 Chapter 6: Alarms and Messages --------------------------------------- 153 About Alarms --------------------------------------------------------- 153 Silencing the Alarms --------------------
Radical-7 Contents Display Indicators ------------------------------------------------------ 183 Compliance ------------------------------------------------------------ 183 Output Interface ------------------------------------------------------- 185 Serial Interface Specifications------------------------------------------ 186 Serial Interface Setup -------------------------------------------------- 186 Analog Output and Nurse Call Specifications ------------------------- 188 Symbols-----------------------
Radical-7 Contents Index --------------------------------------------------------------------- 219 www.masimo.
About this Manual This manual explains how to set up and use the Radical-7® Pulse COOximeter®. 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 effect, death) to the patient or user.
Radical-7 Product Description The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7 features a touchscreen that continuously displays numeric values for all parameters. The Radical-7 provides graphical displays for plethysmographic waveform, respiratory waveform, Signal Identification and Quality Indicator (Signal IQ®).
Radical-7 • Indications for Use Pleth Variability Index (PVI) may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. [The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion.] • Oxygen Reserve Index (ORI) is an index to measure changes in oxygen states under hyperoxic conditions.
Radical-7 Contraindications hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet®), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 and accessories have been validated and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Warnings and Cautions Caution: Radical-7 is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. Safety Warnings and Cautions Warning: Do not use the Radical-7 if it appears or is suspected to be damaged. Warning: Do not start or operate Radical-7 unless the setup was verified to be correct.
Radical-7 Warnings and Cautions • Do not attempt to sterilize the device. • Use cleaning solutions only as instructed in this operator's manual. • Do not attempt to clean Radical-7 while monitoring patient. Warning: To protect from electric shock, always remove the sensor and completely disconnect Radical-7 before bathing the patient. Warning: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
Radical-7 Warnings and Cautions under any circumstances remove the grounding conductor from the power plug. Caution: Only use the AC power cable provided by Masimo. Using a different AC power cable could cause damage to Radical Docking Station. Check the power cord and plug to ensure that it is intact and undamaged. Caution: To ensure patient electrical isolation, all external device connections to the Analog Output/Nurse Call connector must be IEC60950 compliant.
Radical-7 Warnings and Cautions Warning: Do not place containers with liquids on or near Radical-7. Liquids spilled on Radical-7 may cause it to perform inaccurately or fail. Warning: Radical-7 is intended only as an adjunct device in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with clinical signs and symptoms. Warning: A functional tester cannot be used to assess the accuracy of the Radical-7.
Radical-7 Warnings and Cautions Warning: Inaccurate SpHb and SpOC readings may be caused by: • Improper sensor application • Intravascular dyes such as indocyanine green or methylene blue • Externally applied coloring and texture such as nail polish, acrylic nails, glitter, etc.
Radical-7 • Warnings and Cautions Low arterial oxygen saturation levels including altitude induced hypoxemia • Elevated total bilirubin levels • Motion artifact • SpCO readings may not be provided if SpO2 readings are less than 90% • SpCO readings may not be provided if SpMet readings are greater than 2% Warning: SpCO readings may not be provided if there are low arterial saturation levels or elevated methemoglobin levels.
Radical-7 Warnings and Cautions • Low arterial perfusion • Motion artifact • Patient attached to blood pressure cuff • Elevated carboxyhemoglobin levels • Elevated methemoglobin levels • Vasospastic disease such as Raynaud's • Peripheral vascular disease • Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc • Elevated levels of Dyshemoglobin • Patient is under Hypocapnic and Hypercapnic Conditions • EMI radiation interference • Birthmark(s)
Radical-7 Warnings and Cautions Caution: ORI may not indicate additional changes in oxygen states above 200 mmHg of PaO2 Caution: Do not place the Radical-7 on electrical equipment that may affect the device, preventing it from working properly. Caution: The device must be configured to match your local power line frequency to allow for the cancelation of noise introduced by fluorescent lights and other sources. Caution: Do not place the Radical-7 against a surface that may cause the alarm to be muffled.
Radical-7 Warnings and Cautions Caution: If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. Caution: If using pulse oximetry 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.
Radical-7 Warnings and Cautions Note: It is recommended that Radical-7 battery is fully charged prior to use. Note: Always charge Radical-7 when it is not in use to ensure that the Radical-7 battery remains fully charged. Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the battery. Note: Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling.
Radical-7 Warnings and Cautions plethysmographic waveforms displayed on the Radical-7 should be used for monitoring purposes. Warning: Simultaneous use of SatShare and serial port is not supported. Caution: To minimize electromagnetic interference, only use a SatShare cable that has a ferrite bead installed. Caution: During SatShare operation, alarms may be muted on the Radical-7. Use the multi-parameter monitor for audible alarms during SatShare operation.
Radical-7 Warnings and Cautions Warning: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Radical-7. These substances affect the device’s materials and device failure can result. 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 display.
Radical-7 Warnings and Cautions as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. Compliance Warnings and Cautions Warning: Do not incinerate battery. Caution: Dispose of used batteries according to required country or regional instructions. Caution: Disposal of product - Comply with local laws in the disposal of the device and/or its accessories.
Radical-7 Warnings and Cautions harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Radical-7 Warnings and Cautions and that these radars could cause interference and/or damage to LE-LAN devices. Note: In accordance with FCC requirements, radio accessories on Radical7 cannot be attached directly to the patient using any accessory containing metal components.
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 rainbow SET® Parallel Engines This figure is for conceptual purposes only. Masimo SET® DST This figure is for conceptual purposes only. General Description for Oxygen Saturation (SpO2) Pulse oximetry is governed by the following principles: www.masimo.
Radical-7 1. Chapter 1: Technology Overview Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (nonoxygenated blood) differ in their absorption of red and infrared light (spectrophotometry). 2. The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well. Successful Monitoring for SpO2, PR, and PI Stability of the SpO2 readings may be a good indicator of signal validity.
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 hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry). 2. The amount of arterial blood in tissue changes with pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
Radical-7 Chapter 1: Technology Overview 1. Light Emitting Diodes (LEDs) (7 + wavelengths) 2. Detector Once the Radical-7 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient’s functional oxygen saturation (SpO2 [%]), blood levels of carboxyhemoglobin (SpCO [%]), methemoglobin (SpMet [%]), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (PR).
Radical-7 Chapter 1: Technology Overview In the case of SpO2 , different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (pO2 ) and saturation, such as: pH,temperature, the partial pressure of carbon dioxide (pCO 2 ), 2,3-DPG, and fetal hemoglobin.
Radical-7 Chapter 1: Technology Overview General Description for Total Hemoglobin (SpHb) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make its SpHb measurement. The measurement is taken by a sensor capable of measuring SpHb, usually on the fingertip for adults and pediatric patients. The sensor connects directly to the Pulse CO-Oximeter or with a patient cable.
Radical-7 Chapter 1: Technology Overview CaO2 = 1.34 (ml O 2 /g) x Hb (g/dL) x HbO2 + PaO2 (mmHg) x 0.003 (ml O 2 /dL/mmHg) Where HbO2 is the fractional arterial oxygen saturation and PaO2 is the partial pressure of arterial oxygen. For typical PaO2 values, the second part of the above equation is approximately 0.3 ml O2 /dL based on PaO2 being approximately 100 mmHg.
Radical-7 Chapter 1: Technology Overview General Description for Carboxyhemoglobin (SpCO) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carboxyhemoglobin concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants.
Radical-7 Chapter 1: Technology Overview The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry device or through a patient cable. 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 SpMet.
Radical-7 Chapter 1: Technology Overview Successful Monitoring for ORI A stable ORi* 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. See Warnings and Cautions on page 15 and Troubleshooting Measurements on page 171.
Radical-7 Chapter 1: Technology Overview can be processed to produce a respiration rate, measured as breaths per minute. Respiratory sounds include sounds related to respiration such as breath sounds (during inspiration and expiration), adventitious sounds, cough sounds, snoring sounds, sneezing sounds, and sounds from the respiratory muscles [1].
Radical-7 Chapter 1: Technology Overview Signal Envelope Processing 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 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.
Radical-7 Chapter 1: Technology Overview [4] Pastercamp H, Kraman SS, Wodicka GR. Respiratory sounds – Advances beyond the stethoscope. Am J Respir Crit Care Med 1977; 156: 974-987. [5] Gavriely N, Cugell DW. Airflow effects on amplitude and spectral content of normal breath sounds. J Appl Physiol 1996; 80: 5-13. [6] Gavrieli N, Palti Y, Alroy G. Spectral characteristics of normal breath sounds. J Appl Physiol 1981; 50: 307-314. www.masimo.
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. Device 2. Patient Cable 3. Sensor For a list of compatible sensors and cables, visit http://www.masimo.com.
Radical-7 Chapter 2: Radical-7 Descriptions The Handheld contains the majority of the device features. All measurements and device 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. Standalone Pulse Oximeter The Radical-7 is a fully featured Standalone Pulse-Oximeter, and Acoustic Monitor. The Handheld snaps into the Docking Station to provide a fully featured standalone monitor.
Radical-7 Chapter 2: Radical-7 Descriptions Utilizing a SatShare cable, the standalone Radical-7 also interfaces with the SpO2 input of a validated multi-parameter patient monitor, instantly upgrading the conventional pulse oximetry to Masimo SET® pulse oximetry. The SatShare cable attaches to the back of the Radical Docking Station, and SatShare cables are available to interface with most multi-parameter patient monitors. Handheld All user input and displays are controlled by this component.
Radical-7 Chapter 2: Radical-7 Descriptions 1. Handheld Release button Press down the Handheld Release Button to pull the Handheld off the Docking Station. 2. Touchscreen Display The Touchscreen Display refers to the interactive area on the Handheld. There are different Display Views that can appear in this area. For more about using the Touchscreen and Display Views, see Changing the Size of Parameter Values on page 73. 3. Profile button The Profile button provides instant access to the Profile Screen.
Radical-7 Chapter 2: Radical-7 Descriptions silences alarms. See Silencing the Alarms on page 153. 7. Speaker The speaker indicates audio alarms. Care should be taken not to cover the speaker and muffle the audible alarm volume. 8. Patient Cable Connector Connect a patient cable or a direct cable sensor into the Radical-7. Caution: Refer to the Directions for Use for the sensor before applying it on patients.
Radical-7 Chapter 2: Radical-7 Descriptions Item and Description 1. Connector The Handheld interfaces with the Docking Station through this connector. 2. Pole Clamp The optional Pole Clamp accessory attaches to this holder. See the directions for use of the Pole Clamp accessory for attachment instructions. 3. Battery Compartment The Handheld is powered by a lithium ion battery located in this compartment. For battery care and replacement, see Battery Operation and Maintenance on page 196. www.masimo.
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 Docking Station Features Automatic Display Rotation Support (Gravity RDS- RDS- RDS- 1 2 3 Detector) Docking Station Battery Charging indicator Handheld Battery Charging indicator Visual Alarm indicator AC Power indicator Docking indicator Standalone Front Panel The following figure and corresponding text review the features of the Radical-7 Standalone.
Radical-7 Chapter 2: Radical-7 Descriptions Item and Description 1. Docking Station Battery Charging Indicator The Docking Station Battery Charging indicator is illuminated when the Docking Station battery is charging. The indicator blinks just prior to charging. The Charging Indicator does not illuminate when the battery is fully charged or when the battery is not present. 2. Handheld Battery Charging indicator The Handheld Battery Charging indicator is illuminated when the Handheld battery is charging.
Radical-7 Chapter 2: Radical-7 Descriptions Item and Description The Docking indicator is illuminated when the Handheld device is turned on and is properly interfaced to a Docking Station. Standalone Back Panel The following figure and corresponding text review the features of the Radical-7 Standalone. Item and Description 1.
Radical-7 Chapter 2: Radical-7 Descriptions Item and Description 2. Analog Output/Nurse Call connector Use the Analog Output connector with a ferrite bead installed to interface with an analog output device, such as a chart recorder or Nurse Call system. All external device connections to the Analog Output/Nurse Call connector must be IEC-60950 compliant. See Serial Interface Specifications on page 186. 3.
Radical-7 Chapter 2: Radical-7 Descriptions Item and Description 5. Equipotential Ground connector Use the Equipotential Ground connector for grounding. Monitor Interface With SatShare The Radical-7 has a unique SatShare interface that links to most existing multi-parameter patient monitors through a SatShare cable.
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. Remove the device from the shipping carton and examine it for signs of shipping damage. 2. 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. 3. If anything is missing or damaged, contact the Technical Service Department.
Radical-7 • Chapter 3: Setup Connect a hospital-grade power cable (IEC-320 connector type at the device) to the Power Entry module on the Docking Station. • Connect the power cable to an AC power source. • Ensure that the device is adequately powered by verifying that the AC power indicator on the Docking Station is illuminated. See Warnings and Cautions on page 15. Setting Up the Docking Station Place the Docking Station on a stable hard flat surface near the patient.
Radical-7 Chapter 3: Setup • The Battery Charging indicators on the Docking Station flash prior to charging and remain illuminated while the batteries are charging. See Standalone Front Panel on page 54 and Battery Operation and Maintenance on page 196. Setting Up for Philips, Agilent, or HP VueLink To set up for use with VueLink compatible monitors (Philips, Agilent, or HP) 1. On the Radical-7, on the device output screen, for the serial option, select Hp VueLink. 2.
Radical-7 Chapter 3: Setup Setting Up for SpaceLabs Flexport To set up for use with SpaceLabs Flexport 1. On the Radical-7, on the device output screen, for the serial option, select SpaceLabs Flexport. 2. Connect one end of the Spacelabs Flexport cable to the Serial Output connector on the Docking Station. 3. 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. 4.
Radical-7 Chapter 3: Setup plethysmographic waveform and the parameter values. Refer to the instructions for use provided with the multi-parameter monitor. See Compliance on page 183. To set up for use with SatShare interface 1. Select the SatShare cable that is appropriate for the multiparameter monitor. For the latest list of available SatShare cables and validated devices, see www.masimo.com. 2. Connect the labeled end of the SatShare cable to the SatShare Cable connector on the Docking Station.
Radical-7 7. Chapter 3: Setup While in the SatShare mode, if there are any significant discrepancies between the readings from Radical-7 and those on the monitor displaying the values obtained from SatShare, the values reported by the Radical-7 are to be considered the correct values. 8. It is possible to use the Radical-7 with SatShare while the Radical-7 is not connected to AC power. However, in this configuration, battery run time is reduced. See Battery Operation and Maintenance on page 196. 9.
Chapter 4: Operation The following chapter contains information about using the Radical-7. www.masimo.
Radical-7 Chapter 4: Operation Using the Touchscreen and Buttons 1. Display View To access other screens, touch a value on the Display View. See About the Display View on page 70. 2. Profiles button To the access the Profiles screen, press Profiles. See Chapter 5: Profiles on page 145. 3. Alarm Silence button To temporarily silence audible alarms, press Alarm Silence. See Silencing the Alarms on page 153. 4. Home button To return to the Display View, press Home. 5.
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. When turned on, any interaction with the Display View triggers the Screen Lock feature. 2. To bypass Screen Lock when it appears, press and hold the Lock icon until it unlocks. 3. To turn on or turn off Screen Lock, see Access Control on page 117. www.masimo.
Radical-7 Chapter 4: Operation Using the Home Button One option to return to Display View is by using the Home button. To return to Display View using the Home button • From any screen, press Home. Standby and Power Off To put Radical-7 in Standby Mode or to Power Off, follow these steps: State Description Press and hold the Power Button for two (2) seconds until a Standby single audible tone sounds. Mode Standby Mode conserves power while enabling a quicker startup sequence.
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 72. Parameter Display. See Changing the Size of Parameter Values on page 73. www.masimo.
Radical-7 Chapter 4: Operation Trend Field. See Waveform and Trend Views on page 76. Small Parameter View. See Accessing the Main Menu on page 84. www.masimo.
Radical-7 Chapter 4: Operation 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 81. • Profiles. See Profiles Overview on page 145. • Messages on page 161. • WiFi on page 124. • Battery on page 125. • Sounds on page 113. • Time settings.
Radical-7 Chapter 4: Operation Changing the Size of Parameter Values To change the size of parameter values on the Display View 1. On the Small Parameter view, touch and hold any one of the parameters, as shown above. 2. When the parameter value dims, shakes, and grows in size, drag and drop that parameter above the Trend Field. 3. The parameter value appears on the screen in a larger font. The device automatically configures the screen for optimal display of the parameter values. 4.
Radical-7 Chapter 4: Operation 1. Touch the Trend Field, as shown below. 2. The following screen appears. 3. Swipe up or swipe down the available options. 4. Touch on the desired option. www.masimo.
Radical-7 5. Chapter 4: Operation 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 77. www.masimo.
Radical-7 Chapter 4: Operation Waveform and Trend Views The following section contain information about trends and waveforms available from the Trend Field on the Display View screen. The following are examples of some of the views that are available. Pleth + Sig IQ + Acoustic View Shows the parameter values on the top of the screen. The waveform is located below the parameter values. The Small Parameter view is located along the bottom of the screen.
Radical-7 Chapter 4: Operation Signal IQ Indicators The Signal IQ (SIQ), displayed on each individual pulsation, is conveyed by vertical bars, as shown below. The height of the bar provides an assessment of the confidence in the measurement displayed. Acoustic Waveform View Shows the parameter values on the top of the screen. The RRa waveform is located below the parameter values. The Small Parameter view is located along the bottom of the screen.
Radical-7 Chapter 4: Operation Pleth + Sig IQ + Acoustic 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, signal quality indications, and acoustic waveform. 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.
Radical-7 Chapter 4: Operation With a pinch gesture, using two fingers, the user can zoom in and out of the quick trend data within the Trend Field. About Events Feature The Events feature provides graphical display of parameter or measurement alarms and non-clinical exception messages. This feature is only viewable in the Full Trend screen; however, it is available at all times for all parameters and measurements.
Radical-7 Chapter 4: Operation Specific to parameters and measurements Change in In shown in Full Trend Vivo offset. • offset changed: -1.9 screen. • Yellow Whenever in Full Trend Non-clinical screen. exception. SpO2 In Vivo Replace sensor • Low battery • No cable connected In the example below showing two (2) Events, the yellow circle represents a system exception and the red circle represents a parameter alarm related to the patient’s SpO2 level.
Radical-7 Chapter 4: Operation its timestamp (11:34:56 AM), which correlates with the position of the vertical blue line. To view time and reading information about a specific parameter or measurement, tap anywhere along the trend. Using the same example, tapping on the trend somewhere towards the right reveals a message box displaying the parameter reading (SpO2 96) and its timestamp (12:11:32 PM).
Radical-7 Chapter 4: Operation menu by touching on the indicator in the upper left corner of the Display View. The sensitivity levels are as follows: • NORM (Normal Sensitivity) NORM is the recommended sensitivity mode for patients who are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as an intensive care unit (ICU).
Radical-7 Chapter 4: Operation 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 146. 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: www.masimo.
Radical-7 Chapter 4: Operation Device Settings See Device Settings on page 116. Parameter Settings See Parameter Settings on page 87. Profiles See Changing Profiles on page 146. 3D Alarms See 3D Alarms on page 157. Trends See Trends on page 127 and Trend Field on page 73. Sound See Sounds on page 113. www.masimo.
Radical-7 Chapter 4: Operation About See About on page 141. 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. From the Parameter Settings screen, to access the desired parameter, flick the on-screen icons left or right. 2. Touch the icon of the desired parameter. For details, see any of the following sections. SpO2 Settings on page 91. SpHb Settings on page 94.
Radical-7 Chapter 4: Operation Perfusion Index (PI) Settings on page 99. SpCO Settings on page 108. SpMet Settings on page 109. SpOC Settings on page 111. Respiration Rate (RR) on page 101 About Parameter Information Additional information about each parameter is available. To access additional information about parameters 1. From the parameter settings screen, touch the About icon. The following is an example for SpHb. www.masimo.
Radical-7 2. Chapter 4: Operation An About screen appears for the selected parameter. In Vivo Adjustment Overview The In Vivo Adjustment feature lets clinicians manually adjust one or more clinical parameters to match that of a corresponding laboratory reference for continuous trending. To remind clinicians that the feature is active, an offset value displays alongside the adjusted parameter value.
Radical-7 Chapter 4: Operation Offset Value When In Vivo Adjustment is activated for a specific parameter, the offset value appears beneath that specific parameter. A positive value means that the displayed parameter value has been increased (according to a laboratory reference value as entered by a clinician) and a negative value means the displayed parameter value has been decreased (according to a laboratory reference value as entered by a clinician).
Radical-7 Chapter 4: Operation SpO2 Settings Access any of the following options: Alarms for SpO2 on page 91. Additional Settings for SpO2 on page 92. About Parameter Information on page 88. Alarms for SpO2 From the Alarms screen, change any of the following options: Factory Options Description Default Settings Configurable Options 2% to 99% in steps of 1%, The High Limit is upper High Limit threshold that triggers an alarm.
Radical-7 Chapter 4: Operation Factory Options Description Default Settings Configurable Options Sets the Rapid Desat limit threshold to the selected amount below the Low Alarm Rapid Limit. When SpO2 value falls Desat below rapid desat limit the -10% Off, -5%, or 10% audio and visual alarm are immediately triggered without respect to the alarm delay. Alarm Delay When an alarm condition is met, this feature delays the audible part of an alarm.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings Averaging The length of time over Time which the system 12, 14, or 16 calculates the average of seconds 8 seconds 2-4, 4-6, 8, 10, all data points. FastSat See FastSat Overview on Off On or Off page 93. FastSat Overview FastSat enables rapid tracking of arterial oxygen saturation changes.
Radical-7 Chapter 4: Operation In Vivo for SpO2 From the In Vivo screen, change any of the following options: Options Description Factory User Configurable Default Settings Settings Enabled See In Vivo Off On or Off 0 when Adjust difference of ± Adjustment Overview on page 89. Offset See In Vivo Amount Adjustment Overview turned on 6%, in steps of 0.1% on page 89. SpHb Settings From the SpHb Settings screen, access any of the following screens: SpHb Alarms on page 94.
Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings High The High Limit is Limit upper threshold that triggers an alarm. 17.0 g/dL (170 g/L) (11.0 mmol/L) 2.0 g/dL to 24.5 g/dL in steps of 0.1 g/dL, or Off (2 g/L to 249 g/L in steps of 1 g/L, or Off) (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. www.masimo.
Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings Low The Low Limit is Limit lower threshold that triggers an alarm. 7.0 g/dL (70 g/L) (4.0 mmol/L) Off, or 1.0 g/dL to 23.5 g/dL in steps of 0.1 g/dL (Off, or 1 g/L to 248 g/L in steps of 1 g/L) (Off, or 1.0 mmol/L to 14.5 mmol/L, in steps of 0.1 mmol/L) When SpHb Precision is set to 1.0, values are rounded down. When set to Off, alarm is disabled.
Radical-7 Options Chapter 4: Operation Description Factory User Default Configurable Settings Settings Medium Short, Averaging The length of time over which Time the system calculates the Medium, or average of all data points. Long Calibration Provides an arterial or venous Venous value that displays on the main Arterial or Venous screen. Precision Allows the user to set the 0.1 decimal for SpHb. 0.1, 0.5, or 1.
Radical-7 Chapter 4: Operation In Vivo for SpHb From the In Vivo screen, change any of the following options: Options Description Factory User Configurable Default Settings Settings In Vivo See In Vivo Calibration Adjustment Off On or Off 0 ± 3 g/dL in steps Overview on page 89. In Vivo See In Vivo Calibration Adjustment Offset Overview on page 89. of ± 0.1 g/dL PR Settings From the PR Settings screen, change any of the following options: PR Alarms on page 98.
Radical-7 Options Chapter 4: Operation Description Factory Options Default Settings High The High Limit is upper Limit threshold that triggers an bpm, in steps of 5 alarm. bpm 140 bpm 50 bpm 35 bpm to 235 Low The Low Limit is lower 30 bpm to 230 Limit threshold that triggers an bpm, in steps of 5 alarm. bpm Perfusion Index (PI) Settings From the PI Settings screen, access any of the following screens: PI Alarms on page 99. Additional Settings for PI on page 100.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings High The High Limit is upper Limit threshold that triggers an Off Step size: 0.04 to 0.09 in alarm. steps of 0.01 0.10 to 0.90 in steps of 0.10 1 to 19 in steps of 1, or Off Low The Low Limit is lower Limit threshold that triggers an Off alarm. Step size: Off, or 0.03 to 0.09 in steps of 0.01 0.10 to 0.90 in steps of 0.
Radical-7 Options Chapter 4: Operation Description Averaging The length of time over Time which the system calculates Factory User Default Configurable Settings Settings Long Short or Long the average of all data points. Respiration Rate (RR) The Radical-7 can determine respiration rate (RR) either by the acoustic signal (RRa) or by the plethysmographic waveform (RRp).
Radical-7 Chapter 4: Operation Note that the Radical-7 can monitor RRa or RRp but not both simultaneously. RRp is active under the following conditions: • RRp is installed on the Radical-7. • Dual Rainbow cable is disconnected. • Pulse oximetry or pulse CO-Oximetry sensor is connected. • Acoustic sensor is not connected. When using an acoustic sensor, respiration rate (RR) is determined by the acoustic (RRa) signal. See rainbow Acoustic Monitoring (RAM) Technology on page 42.
Radical-7 Options Chapter 4: Operation Description Factory Configurable Options Default High The High Limit is upper 30 breaths 6 breaths per minute Limit threshold that triggers an per to 69 breaths per alarm. minute minute, or Off Low The Low Limit is lower 6 breaths 5 breaths per minute Limit threshold that triggers an per to 68 breaths per alarm.
Radical-7 Options Freshness Chapter 4: Operation Description The duration of time that, Factory User Default Configurable Settings Settings 5 minutes 0, 1, 5, 10, 15 during interference, the minutes system displays the last valid reading. 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.
Radical-7 Options Chapter 4: Operation Description Factory Configurable Options Default Settings High Limit The High Limit is upper 30 6 to 69 breaths per threshold that triggers breaths minute in steps of 1 an alarm. per breaths per minute, minute or Off The Low Limit is lower 6 breaths 5 to 68 breaths per threshold that triggers per minute in steps of 1 an alarm.
Radical-7 Options Chapter 4: Operation Description Factory User Default Configurable Settings Settings Slow Trending, No, Averaging The length of time over Time which the system calculates Fast, Medium, or the average of all data Slow points. Freshness The duration of time that, 5 minutes during interference, the 10, 15, 0, 1, or 5 minutes system displays the last valid reading. PVI Settings From the PVI Settings screen, access any of the following options: PVI Alarms on page 106.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings High The High Limit is upper Limit threshold that triggers an Off 2 to 99, in steps of 1, or Off alarm. When set to Off, alarms are disabled. Low The Low Limit is lower Limit threshold that triggers an Off, 1 to 98 in steps Off of 1 alarm. When set to Off, alarms are disabled.
Radical-7 Chapter 4: Operation SpCO Settings From the SpCO Settings screen, access the following screens: SpCO Alarms on page 108. About Parameter Information on page 88. SpCO Alarms From the SpCO Settings screen, access the following screens: Options Description Factory User Configurable Default Settings Settings High The High Limit is the Limit upper threshold that 10 2% to 98%, in steps of 1%, or Off triggers an alarm.
Radical-7 Options Enabled Chapter 4: Operation Description Factory User Default Configurable Settings Settings See In Vivo Adjustment Off On or Off Overview on page 89. Offset See In Vivo Adjustment 0 ± 9% in steps of Amount Overview on page 89. 0.1% SpMet Settings From the SpMet Settings screen, access the following screens: SpMet Alarms on page 109. About Parameter Information on page 88. SpMet Alarms From the Alarms screen, change any of the following options: www.masimo.
Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings High The High Alarm Limit is Limit upper threshold that 3.0 1% to 2% in steps of 0.1% triggers an alarm. 2.5% to 99.5% in steps of 0.5%, or Off Low The Low Alarm Limit is Limit lower threshold that Off Off, 0.1% to 2.0% in steps of 0.1% triggers an alarm. 2.5% to 99%, in steps of 0.
Radical-7 Options Chapter 4: Operation Description Offset Helps offset individual patient Amount bias that is expected when Factory User Default Configurable Settings Settings 0 ±3% in steps of 0.1% comparing a noninvasive measurement to a laboratory reference. SpOC Settings From the SpOC Settings screen, access the following screens: SpOC Settings on page 111. About Parameter Information on page 88.
Radical-7 Chapter 4: Operation Options Description Factory User Configurable Default Settings Settings Low The Low Limit is the lower Limit threshold that triggers an Off Off, or 1% to 33% in steps of 1% alarm. ORI Settings The ORI Settings screen can only be accessed on Root. From the ORI Settings screen, access the following screens: ORI Alarms on page 112. About Parameter Information on page 88.
Radical-7 Options Chapter 4: Operation Description Trending The Trending Down Alarm Down is displayed when a rapid Alarm decrease in ORI is Factory User Default Configurable Settings Settings Off On/Off measured. Sounds From the Sounds screen, change any of the following options: Options Description Factory User Configurable Settings Default Settings Alarm Sets the alarm Volume volume and Level 4 Level 1 to 4 provides a sample of the alarm volume. www.masimo.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Settings Default Settings Pulse Sets the volume Tone of the tone that Volume conveys the Level 3 Off, Level 1 to 4 pulse rate. www.masimo.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Settings Default Settings Silence Length of time 120 30, 60, 90, or 120 seconds Duration that the audible seconds alarm remains If All Mute is set to On (see Access Control on page 117), muted. then the following additional settings become available: All Mute If selected, then no alarms will sound. Only visual elements are enabled. The following icon appears on the Display View.
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 123. Localization on page 121. WiFi on page 124. Battery on page 125. Brightness on page 125. Access Control on page 117. Device Output on page 126. www.masimo.
Radical-7 Chapter 4: Operation Access Control Password Screen The Access Control screen is password-protected. Using the Password screen www.masimo.
Radical-7 1. Chapter 4: Operation On the Password screen, enter the following numbers: 6 2 7 4 No numbers will be displayed, only asterisks (****). 2. Touch Enter. 3. To undo numbers, touch Backspace. Settings From the Access Control screen, change any of the following options: www.masimo.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings Allows user to select a specific Profile to be loaded the next time that Previous Profile, the unit is powered on. Power This Profile can be one of On the presets (ie. Adult, Profile Pediatric, Neo), a Adult, Pediatric, Previous Neonatal, Custom, Profile Custom1, Custom2, Custom3, Custom4, customized Profile, or the Custom5 last configuration used before the unit is powered off.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings When set to 3 or 4, 3 or 4 Lock shows dimly lit in the Alarm Alarm Volume section of Volume the Alarms Menu screen Off 3, 4, or Off and cannot be changed. SpO2 Threshold at which SpO2 Low % Low Alarm Limit cannot be Limit reduced.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings Press Save to load all Saves pre-configured Save as profiles for neonatal Neo patients N/A device configuration settings to neonatal profile. Factory Defaults Press Restore to Options are restored to factory values. N/A return to factory default values.
Radical-7 Options Chapter 4: Operation Description Time Zone Setting based on Factory User Default Configurable Settings Settings A (UTC+1hr) Choose local Coordinated Universal time zone Time (UTC). settings. Date Set the format of the Format date display on the MM/DD/YYYY MM/DD/YYYY DD/MM/YYYY Display View. Time Set the format of the Format time display as it will be 12 hour 24 hour or 12 hour shown on the Display View.
Radical-7 Options Time Chapter 4: Operation Description Factory User Default Configurable Settings Settings Manually set the hour 12-hour Choose hour and minute, AM or PM, if format and minute. Auto Set Date/Time is Off.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings Orientation Rotates the viewing Landscape Landscape: rotates screens depending on the screen to device orientation.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings WiFi Enables or disables the Off On or Off wireless connection Additional fields in the Wifi screen provide information about WiFi connection. These additional fields are read only and not configurable. Battery From the Battery screen, view the following information: • Battery icon that conveys remaining battery charge as a green color.
Radical-7 Options Chapter 4: Operation Description Brightness The slider option adjusts the Factory User Default Configurable Settings Settings 4 Level 1 to 4 brightness level of the display and provides a sample of the brightness level.
Radical-7 Options Chapter 4: Operation Description Factory User Configurable Default Settings Settings Analog 2 Depending on the Pleth, SIQ, 0V configuration, the following parameters are output continuously on the Analog Output, 1V Output, N/A SpO2 0% to 100%, SpO2 50% to 100%, 1 and Analog 2. or Pulse rate Nurse The nurse call output will be Call activated based on the Trigger alarm events.
Radical-7 Chapter 4: Operation About Trend Views There are different ways to view trend information. The following is an example of trend information for SpO2 as it appears within the Display View screen. 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 www.masimo.
Radical-7 1. Chapter 4: Operation From the Display View, in the Trend Field, touch the icon as shown below. 2. From the Full Trend screen, touch the icon as shown below. Using the Events Feature The Events feature provides graphical display of parameter or measurement alarms and non-clinical exception messages. This feature is only viewable in the Full Trend screen; however, it is available at all times for all parameters and measurements.
Radical-7 Chapter 4: Operation Color of Visibility Description Event Example Messages Circle Red Parameter or • SpO2 low Specific to parameters measurement • SpCO high and measurements alarm. • PR low • SpO2 In Vivo shown in Full Trend screen. Change in In offset Vivo offset. changed: -1.9 • Yellow Whenever in Full Trend Non-clinical screen. exception.
Radical-7 Chapter 4: Operation If there are two (2) parameters and/or measurements displayed in the Full Trend screen, then only Events related to those parameters and/or measurements will be visible. Using the same example, tapping on the red circle reveals a message box displaying the alarm (Start SpO2 Low), the reading (SpO2 87), as well as its timestamp (11:34:56 AM), which correlates with the position of the vertical blue line.
Radical-7 Chapter 4: Operation Manipulating View of Trend Data On the Full Trend screen, with a pinch gesture, using two fingers, the user can zoom in and out of the trend time scale. The user can add parameters to the Trend view by dragging and dropping parameters from the Small Parameter view. 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 www.masimo.
Radical-7 1. Chapter 4: Operation From the Display View, in the Trend Field, or from the Full Trend screen, touch the Time Interval icon. 2. 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. Navigate to a Full Trend screen. See Changing Between Trend Views on page 128. www.masimo.
Radical-7 2. Chapter 4: Operation The Histogram icon appears along the top of the Trend Field, as shown in the following example for SpO2 . 3. Touch the Histogram icon. 4. Trend data displays as a histogram. To turn off the Histogram feature www.masimo.
Radical-7 • Chapter 4: Operation Touch the Trends icon, as shown. Changing Histogram Settings Users can change the ranges of bins in the histogram view for each individual parameter displayed. To access the histogram settings for any of the available parameters: 1. From the Main Menu screen, touch the Parameter Settings icon. 2. From any Parameter Settings screen, touch the Histogram icon. To change the histogram settings for any of the available parameters: www.masimo.
Radical-7 Chapter 4: Operation 1. Touch any bin to change the range values. 2. Touch and drag the markers to adjust the range values. 3. When finished, touch the back arrow and select OK. Changing Trend Settings There are several ways to access and then change the maximum value and the minimum value of the Y axis for any of the available parameters. To access the trend settings for any of the available parameters 1. From the Main Menu screen, touch the Trends icon. www.masimo.
Radical-7 2. Chapter 4: Operation From the Trends screen, touch any of the available parameters. Alternatively, from any Parameter Settings screen, touch the Trends icon. 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. www.masimo.
Radical-7 Chapter 4: Operation When viewing trends for an additional parameter, the Y axis range appears on the right side of the screen. To change the trend settings for any of the available parameters 1. Touch the slider for the Y-axis maximum or the Y-axis minimum. The following is an example of the SpO2 Trend screen. www.masimo.
Radical-7 Chapter 4: Operation 2. Select the desired setting by scrolling up or down. 3. When finished, select OK. Deleting Trend Data The user can delete patient trend data that has been stored on the Radical-7. To delete patient trend data 1. From the Trends screen, touch the Trend Settings icon. www.masimo.
Radical-7 2. Chapter 4: Operation From the Trend Settings screen, touch Clear, and then touch OK. This deletes all stored trend data. About For information about parameters, see About Parameter Information on page 88. 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 device board software. www.masimo.
Radical-7 Chapter 4: Operation Options Description MX Board Displays the version number of the technology level software. Processor Displays the version number of the system level software. Docking If docked, displays the current software version of the Station Docking Station. Visualization When the Radical-7 is connected to Root, the Radical-7 provides a supplemental visualization of the alarm status for the connected Masimo medical technologies. www.masimo.
Radical-7 Chapter 4: Operation Color Description Table This visualization displays a human body on the Radical-7 device when it is connected to Root.
Radical-7 Chapter 4: Operation Parameter or Measurement Area Displayed on Visualization Screen PVI Vascular SpHb Vascular SpMet Vascular SpCO Lung RRa Lung SpfO2 * Lung RRp* Lung SpOC N/A PSI** Brain *CE marked only. Not available in the USA. **For use with SedLine® Sedation Monitor, upon availability www.masimo.
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. • Pediatric Displays in the Status bar as PEDIATRIC and the color of the Profile button turns pink.
Radical-7 Chapter 5: Profiles The active profile displays in the Status Bar. In the following example, the Adult profile is active. The Radical-7 conveys the active profile by changing the color of the Profiles button. To restore all Radical-7 settings to factory default settings, see Access Control on page 117. Changing Profiles Changing Profiles is done in the Profiles Settings screen. There are different ways to access the Profiles Settings screen. www.masimo.
Radical-7 • Chapter 5: Profiles The first way is by the touching the Profiles shortcut in the Status Bar, as show below. • Another way to access the Profiles Settings screen is by pressing the Profile button, as shown below. www.masimo.
Radical-7 • Chapter 5: Profiles Alternatively, from the Main Menu screen, touch the Profiles icon. To change Patient Type 1. From the Profile screen, touch the Patient Type field. www.masimo.
Radical-7 Chapter 5: Profiles 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 Factory User Default Configurable Settings Settings Adult Neonatal, Adult, Patient Defines the patient Type population for which the Custom, or device will operate.
Radical-7 Chapter 5: Profiles Silence The amount of time for Duration which the audible part of an 2 min 1 min, 2 min, or 3 min alarm will be silenced. See Silencing the Alarms on page 153. Smart Allows the audible pulse to Tone continue to beep when the Off On or Off pleth graph shows signs of motion.
Radical-7 Chapter 5: Profiles 3. For either Adult or Neonatal, touch Save. 4. Touch Ok. 5. Alternatively, the user can restore all Profile settings to their factory default values by touching Restore, and then touching Ok. 6. Confirm the changes by powering off and powering on the Radical-7 and then verifying settings. Powering Off the Radical-7 When turning off the Radical-7, the device remembers the preferred settings. To turn off the Radical-7 1.
Radical-7 2. Chapter 5: Profiles 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 171. 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 Warnings and Cautions on page 15.
Radical-7 Chapter 6: Alarms and Messages The following is an example of a visual alarm for an exception message: The following is an example of a typical alarm due to parameter limit violation. To silence or dismiss alarms: • Touch Silence (the highlighted area of the Status Bar). 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. www.masimo.
Radical-7 Chapter 6: Alarms and Messages To silence audible alarms 1. When an audible is active, push Alarm Silence one time. 2. The audible alarm is silenced for up to 120 seconds and a countdown timer displays. 3. The length of time for which an audible alarm remains silenced (suspended) can be changed using the Silence Duration feature located on the Sounds screen. See Sounds on page 113. www.masimo.
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 it also serves as absolute low alarm limit protection. SpO2 values exceeding the Rapid Desat low alarm limit, whether rapid or not, will activate an audible alarm. The user can change the Rapid Desat default setting from 5% to 10%. ATA does not allow a Rapid Desat default setting of 0%. When ATA is turned Off, the device uses the standard alarm limits and standard alarm delays. About Alarms on page 153. Alarms for SpO2 on page 91.
Radical-7 Chapter 6: Alarms and Messages typically established at a considerable change from the patients’ baseline saturation level.
Radical-7 Options Chapter 6: Alarms and Messages Description Factory User Configurable Default Settings Settings See Desat Index Alarm 4% 2% to 10% in steps of Overview on page 157. 1%. See Desat Index Alarm 1 hour 1 to 4 hours, in steps Overview on page 157. of 1. # of See Desat Index Alarm Off Off, 1 to 24 Events Overview on page 157. desaturations in steps Delta Time of 1.
Radical-7 Chapter 6: Alarms and Messages The PI Delta provides an audible and visual alert to important changes in perfusion compared to the patient’s baseline PI rate. The baseline is set by the Radical-7 once the user has enabled the alarm. The baseline is 30 seconds of currently averaged PI. The feature includes a user-selectable PI Delta Alarm.
Radical-7 Options Chapter 6: Alarms and Messages Description Factory User Configurable Default Settings Settings Set See Perfusion Index Baseline (PI) Delta Alarm Off On or Off See Perfusion Index Off, or PI N/A (PI) Delta Alarm baseline Overview on page 159. Baseline Overview on page 159. Percent See Perfusion Index Change (PI) Delta Alarm 50% 10% to 99% in steps of 1% Overview on page 159.
Radical-7 Chapter 6: Alarms and Messages Replace Sensor Message Message: • (Pulse CO-Ox) Replace Sensor, or • (RAM) Replace Sensor Reusable sensor has used all its available monitoring time, sensor is nonfunctional, or defective sensor. Next steps: Replace sensor. 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 Incompatible Sensor Message Message: • (Pulse CO-Ox) Incompatible Sensor, or • (RAM) Incompatible Sensor Not a proper Masimo sensor. Next steps: Replace with a proper Masimo sensor. Sensor is attached to a device without an appropriate parameter installed. Next steps: Use a compatible sensor. Contact your local Masimo Representative to learn more about optional parameter upgrades.
Radical-7 Chapter 6: Alarms and Messages When a single-patient-use sensor is used, the adhesive portion of the sensor is not connected. Next steps: Ensure the adhesive portion is firmly connected to the sensor. Interference Detected Message Message: • (Pulse CO-Ox) Interference Detected, or • (RAM) Interference Detected High intensity light such as pulsating strobe lights, excessive ambient light sources such as surgical lights or direct sunlight, or other monitor displays.
Radical-7 Chapter 6: Alarms and Messages RAM unable to collect pulsing through RAM Sensor. Next steps: Ensure proper sensor application. Check that no object is pulling on the sensor cable causing the sensor to peel off. RAM Sensor Initializing Message Message: (RAM) Sensor Initializing Device is checking the sensor for proper functioning and performance. Next steps: If values are not displayed within 30 seconds, disconnect and reconnect sensor.
Radical-7 Chapter 6: Alarms and Messages Low signal quality. Next steps: Ensure proper sensor application. Move sensor to a better perfused site. See Signal IQ (SIQ). 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 40. Low SpMet SIQ Message SpMet measurement reading is obscured. Next steps: Ensure proper sensor application.
Radical-7 Chapter 6: Alarms and Messages Invalid Parameter Alarm Message Denoted by dashes shown as parameter value. Unable to provide a SpO2 or PR parameter value. Next steps: Check patient's vital condition. No Cable Connected Message Message: • (Pulse CO-Ox) No Cable Connected, or • (RAM) No Cable Connected Cable not attached or not fully inserted into the connector. Next steps: Disconnect and reconnect cable into connector.
Radical-7 Chapter 6: Alarms and Messages Sensor is disconnected from patient cable. Sensor connected upside down into patient cable. Next steps: Check to see if the sensor LED is flashing. Disconnect and reconnect the sensor. If the LED fails to operate, replace the sensor. Pulse Search Message Message: (Pulse CO-Ox) Pulse Search Device is searching for pulse. Next steps: If device fails to display within 30 seconds, disconnect and reconnect.
Radical-7 Chapter 6: Alarms and Messages Sensor not connected to patient properly. Sensor is damaged. Next steps: Properly reapply the sensor on the patient and reconnect the sensor to the device or patient cable. If the sensor is damaged, replace the sensor. Incompatible Cable Message Message: (Pulse CO-Ox) Incompatible Cable Not a proper cable. Next steps: Replace with a proper cable.
Radical-7 • Chapter 6: Alarms and Messages (RAM) Adhesive Near Expiration Disposable sensor has less than 10% active monitoring life remaining. Next steps: Replace with new disposable sensor. www.masimo.
Chapter 7: Troubleshooting The following chapter contains information about troubleshooting the Radical-7 system. Troubleshooting Measurements See Safety Warnings and Cautions on page 15. Signal IQ (SIQ) The Signal IQ provides an indicator of the assessment of the confidence in the displayed 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 Check the sensor and ensure proper sensor application. The sensor must be well secured to the site for the Radical-7® Pulse CO-Oximeter® to maintain accurate readings. Misalignment of the sensor’s emitter and detector can result in smaller signals and cause erroneous readings. • Determine if an extreme change in the patient’s physiology and blood flow at the monitoring site occurred, (e.g.
Radical-7 Chapter 7: Troubleshooting Low Perfusion It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation This "localized hypoxemia" may result from the metabolic demands of other tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral hypoperfusion. This may occur even with a pulse rate that correlates with the ECG heart rate.
Radical-7 Chapter 7: Troubleshooting Unexpected SpO2, SpCO, SpMet, or SpHb Reading • Low SIQ or PI values. Next steps: Reposition sensor to site with strong SIQ and PI. Average readings taken from three different sites to improve accuracy. Submit blood sample for laboratory CO-Oximetry test for comparison. • Inappropriate sensor size or sensor measurement location. Next steps:Verify proper sensor for patient size. Verify proper sensor site. See Appendix on page 209.
Radical-7 • Chapter 7: Troubleshooting Excessive ambient or strobing light. Next steps: Shield the sensor from excessive or strobing light. Minimize or eliminate motion at the monitoring site. SpCO Reading Displays as Dashes • SpO2 value below 90% Next steps: Assess/address patient condition. • SpMet value greater than 2% Next steps: Laboratory analysis of a blood sample should be performed.
Radical-7 Chapter 7: Troubleshooting the condition persists, requires service. See. Contacting Masimo on page 204. 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 204. Buttons Do Not Work When Pressed Internal failure. Next steps: Requires service. See Contacting Masimo on page 204.
Radical-7 www.masimo.
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 0% to 99% (Carboxyhemoglobin) 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 Measurement Display Range RRp (Respiration Rate) 0 breaths per minute to 70 breaths per minute Accuracy (ARMS) Oxygen Saturation (SpO 2 ) No Motion [1] Adults, Pediatrics, Infants 3% Adults, Pediatrics, Infants 2% Neonates 3% (SpO2 from 60% to 80%) No Motion [2] (SpO2 from 70% to 100%) Motion [3] (SpO2 from 70% to 100%) Low perfusion [4] (SpO2 from 70% to 100%) All patient populations All patient populations 3% 2% Pulse Rate (PR) Range 25 to 240 bpm
Radical-7 Chapter 8: Specifications Low Perfusion All patient populations 3 bpm Carboxyhemoglobin Level (SpCO) [1] Range of 1% to 40% Adults, Pediatrics, Infants 3% Methemoglobin Level (SpMet) [1] Range 1% to 15% All patient populations 1% Total Hemoglobin SpHb [6] Range of 8 g/dL to 17 g/dL Adults, Pediatrics 1 g/dL Respiratory Rate (RRa, RRp) [11] Range of 4 to 70 bpm Adults, Pediatrics 1 bpm Resolution Parameter Resolution %SpO2 1% %SpCO 1% %SpMet 0.1% SpHb g/dL 0.1 g/dL www.
Radical-7 Chapter 8: Specifications Parameter Resolution Pulse Rate 1 beats per minute Respiration Rate 1 breath per minute Electrical Standalone AC Power 100 to 240 VAC, 47 to 63 Hz requirements Power 55 VA consumption UL Listed, Metric (5x20mm), rated 250 VAC, 1 Amp, Fuses Fast Acting, 1500A breaking capacity Handheld Battery Type Lithium ion Capacity 4 hours [7] Time 3 hours www.masimo.
Radical-7 Chapter 8: Specifications Environmental Environmental Conditions Operating Temperature 32°F to 122°F (0°C to 50°C) Transport/Storage Temperature -40°F to 158°F (-40°C to 70°C) [8] Operating Humidity 10% to 95%, non-condensing Operating Altitude 500 mbar to 1060 mbar -1000 ft to 18,000 ft (-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 19.6 cm) www.masimo.
Radical-7 Chapter 8: Specifications Weight Handheld 1.2 lbs. (0.54 kg) Docking Station (RDS-1, RDS-2, RDS-3) 2.5 lbs. (1.14 kg) Standalone (RDS-1, RDS-2, RDS-3) 3.8 lbs. (1.73 kg) Alarms Technical Alarm Description Type High Priority Medium Priority Low Priority 571 Hz tone, 5-pulse burst, pulse spacing: 0.250s, 0.250s, 0.500s, 0.250s, repeat time:10s 550 Hz tone, 3-pulse burst, pulse spacing: 0.375s, 0.
Radical-7 Chapter 8: Specifications Display Indicators Item Description Trend Memory Max of 96 hours at 2-second resolution Display Update Rate 1 second Type Backlit Active Matrix TFT LCD Pixels 480 dots x 272 dots Dot Pitch 0.25 mm Compliance EMC Compliance IEC 60601-1-2:2007, Class B Safety Standards Compliance UL 60601-1 IEC 60601-1:1988 +A1:1991 +A2:1995 IEC 60601-1:2012 EN 60601-1:2013 www.masimo.
Radical-7 Chapter 8: Specifications EN/ISO 80601-2-61:2011 CAN/CSA C22.2 No. 601-1 Equipment Classification per IEC 60601-1 Type of Protection Internally powered (on battery power) Degree of Protection of Defibrillation proof BF-Applied Part Electrical Shock Protection against harm from IPX1 Protection against liquid drops liquid ingress falling vertically. Mode of Operation Continuous Wireless Radio (If Installed) Radio Modes 802.
Radical-7 Chapter 8: Specifications Wireless Radio (If Installed) Duty Cycle 6% (maximum) (Note: The software sends 120 bytes at 62.5 Hz for 7,500 bytes per second, or 60 Kbps. Worst duty cycle will be at the minimum transmission bit rate of 1.1 Mbps. Therefore, the calculated duty cycle is 0.06 Mbps / 1.1 Mbps, which results in a duty cycle of approximately 6%.) Compliance USA FCC ID: VKF-RAD7CA or VKF-RAD7A or VKF-RAD7B. FCC parts 15.207, 15.209, 15.247, and 15.
Radical-7 Chapter 8: Specifications 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) Serial Interface Specifications The digital interface for serial communication is based on the standard RS-232 protocol. The Radical-7 by default always outputs ASCII 1 text data through the serial port, unless the user selects a different output mode.
Radical-7 Chapter 8: Specifications Parameter Setting Parity None Bits 1 start, 1 stop Handshaking None Connector type Female DB-9 The pin-outs for the RS-232 connector are shown in the following table: Pin Signal name 1 No Connection 2 Receive data – RS-232 ±9 V (±5 Vmin) 3 Transmit data – RS-232 ±9 V (±5 Vmin) 4 No Connection 5 Signal Ground Reference for COM signals 6 No Connection 7 No Connection 8 No Connection 9 No Connection www.masimo.
Radical-7 Chapter 8: Specifications Analog Output and Nurse Call Specifications Analog Out and Nurse Call are accessible on the same female highdensity 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 10 Ground 11 Ground 12 Nurse Call -Common 13 Ground 14 Ground 15 Analog 2 Analog Output The Radical-7® Pulse CO-Oximeter® can interface with various analog recording devices 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.
Radical-7 Chapter 8: Specifications flexibility, either normally open (pin 6) or normally closed (pin 7) signals are available. Only qualified personnel should connect one of these two signals and common (pin 12) to a hospital’s Nurse Call system. During an alarm condition or a Low Signal IQ event, depending on the configuration, the normally open pin will be connected to the common pin and the normally closed will be disconnected.
Radical-7 Symbols Chapter 8: Specifications Definition Symbols Definition Follow Instructions for Fragile/breakable, Use handle with care Fuse replacement Date of Manufacture IPX1 Protection against Analog Out interface liquid drops falling vertically Defibrillation proof type Nurse Call interface BF Separate collection for Authorized electronic waste Representative in the European Community Mark of conformity to European Medical Caution Device Directive 93/42/EEC Federal law restricts t
Radical-7 Symbols Chapter 8: Specifications Definition Symbols Definition UL, LLC.
Radical-7 Chapter 8: Specifications [2] The Masimo rainbow SET technology with Masimo sensors has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70%-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population weight.
Radical-7 Chapter 8: Specifications [6] SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8 g/dL to 17 g/dL SpHb against a Coulter Counter. The variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.
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. Warnings and Cautions on page 15.
Radical-7 Chapter 9: Service and Maintenance Battery Operation and Maintenance The Radical-7 Handheld includes a lithium ion rechargeable battery. The Radical-7 Docking Station may include the optional 6.5 amp-hour nickel metal hydride rechargeable battery. Before using the Radical-7 as a Handheld or as a transport monitor, the Handheld rechargeable battery and the optional Docking Station rechargeable battery must be fully charged.
Radical-7 • Chapter 9: Service and Maintenance Memory effects of the battery may shorten run-time. When battery run time is significantly reduced, it is advisable to completely discharge and fully recharge the battery. Charging can occur while the Handheld is docked and turned on, the most efficient charge times are achieved when the Handheld is turned off.
Radical-7 Chapter 9: Service and Maintenance Station). However, the capacity of the Handheld battery pack is not sufficient to support this mode for long periods of time. For optimal battery run time, configure the device to automatically adjust the brightness. See Brightness on page 125.
Radical-7 Chapter 9: Service and Maintenance See Battery Operation and Maintenance on page 196. Replacing the Fuses Should a power problem blow one or both of the fuses in the power entry module on the rear panel, the fuse(s) will need to be replaced. Before starting, the user will need a 5-mm or 3/16-in screwdriver. To replace the fuse(s) 1. Disconnect device from AC power. 2. Remove AC power cord from the power entry module at the rear of the Docking Station. 3.
Radical-7 Chapter 9: Service and Maintenance The device is ready to be reconnected to AC power. If the fuses blow shortly after replacement, the device requires service. 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.
Radical-7 2. Chapter 9: Service and Maintenance Upon connection, the device emits a tone and the Masimo logo displays. Alarm Limit Test To conduct an Alarm Limit Test 1. Change the High SpO2 Alarm parameter to a value two points below the currently selected value. See Alarms for SpO2 on page 91. 2. Verify that the newly set parameter is shown on the Display screen. 3. Return the parameter to its original setting. 4. Repeat steps 1 to 3 for all active parameters. 5.
Radical-7 2. Chapter 9: Service and Maintenance Ensure that there are no audible alarms and that the Audible Alarm feature is not set to silenced. 3. Verify the Nurse Call polarity is set to normal. 4. Connect the common lead of a digital multi-meter to the pin 12 (Nurse Call Common) of the Analog Output connector on the Radical-7.
Radical-7 7. Chapter 9: Service and Maintenance Repeat steps 5 and 6, with the positive lead of the voltmeter connected to pin 15 (analog 2). See Serial Interface Specifications on page 186. 8. Connect a patient cable and sensor and verify that the voltage on pins 9 and 15 are between 0V and 1.0V while measuring a saturation and pulse rate. Battery Test To conduct a Battery test 1. Fully charge the Radical-7 by placing the Handheld into the Docking Station and then connect the AC power. 2.
Radical-7 Chapter 9: Service and Maintenance Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning. Make sure the equipment is fully dry before packing. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely, in the original shipping container if possible, and enclose or include the following information and items: • A letter describing in detail any difficulties experienced with the Radical-7.
Radical-7 Chapter 9: Service and Maintenance Limited Warranty Masimo warrants to the original end-user purchaser the Masimo-branded hardware product (Radical-7® Pulse CO-Oximeter®) and any software media contained in the original packaging against defects in material and workmanship when used in accordance with Masimo’s user manuals, technical specifications, and other Masimo published guidelines for a period of 12 months and any batteries for six (6) months from the original date the Product was obtained
Radical-7 Chapter 9: Service and Maintenance (h) damaged by accident, abuse, misuse, liquid contact, fire, earthquake or other external cause. No warranty applies to any Product provided to Purchaser for which Masimo, or its authorized distributor, is not paid; and these Products are provided AS-IS without warranty.
Radical-7 Chapter 9: Service and Maintenance agreement between the parties regarding your purchase of this Product. If you do not agree to the terms of this agreement, promptly return the entire Product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund. Restrictions 1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted.
Radical-7 Chapter 9: Service and Maintenance automatically to any party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void. 4. U.S.
Appendix Concepts of Alarm Response Delay As with any pulse oximeter equipment, the audible and visual alarms are subject to alarm response delay, which is composed of Alarm Condition Delay and Alarm Signal Generation Delay. Alarm Condition Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists. While Alarm Signal Generation Delay is the time from the onset of an alarm condition to the generation of its alarm signal.
Radical-7 Appendix Reference Definition SpO2 t Saturation Time The Alarm Condition Delay is graphically represented as t2 – t1 in the figure above to show the delay due to processing and averaging. The Alarm Signal Generation Delay is graphically represented as t3 – t2 in the figure above to show the delay due to alarm system strategy and communication time. The overall alarm system delay time is graphically represented as t3 – t1. For more information about alarm response delay, refer to ISO 80601-261.
Radical-7 Appendix Guidance and Manufacturer's Declarations - Electromagnetic Emissions ME Equipment uses RF energy only for its internal function. Therefore, its RF RF Emissions Group 1 CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment. Suitable for use in all establishments, RF Emissions CISPR 11 Class B including domestic environments.
Radical-7 Appendix Manufacturer's Declaration-Electromagnetic Immunity Guidance and Manufacturer's Declaration - Electromagnetic Immunity The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity Surge IEC 61000-4-5 +/-1 kV Mains power quality should line(s) to be that of a typical line(s) commercial or hospital environment. +/- 2 kV line(s) to earth Voltage dips, 100% Mains power quality should short dip in be that of a typical interruptions mains commercial or hospital and voltage voltage environment. variations on for 0.
Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity Power 3 A/m 3 A/m Power frequency magnetic frequency (50 / fields should be at levels 60 Hz) magnetic characteristic of typical field. location in a typical hospital environment.
Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency rangeb.
Radical-7 Appendix Guidance and Manufacturer's Declaration - Electromagnetic Immunity Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Radical-7 Appendix Recommended Separation Distances Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Radical-7 Appendix For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations.
Index Adaptive Threshold alarm (ATA) 3 Additional Settings for PI • 61 3D Alarms • 53, 101 Additional Settings for PVI • 65 Feature • 57, 101 Additional Settings for RRa • 64 A Additional Settings for RRp • 63 About • 53, 89 Additional Settings for SpHb • About Alarms • 99, 101 58, 59 About Events Feature • 48 Additional Settings for SpO2 • About Parameter Information • 56, 57 55, 56, 58, 60, 61, 64, 65, 66, Alarm Limit Test • 130 67, 68, 89, 102, 103 Alarms • 118 About the Display Vie
Radical-7 Index Setup • 35 Battery Run Time Significantly Reduced • 114 Chapter 4 Battery Test • 131 Operation • 39 Chapter 5 Brightness • 71, 76, 113, 128 Profiles • 29, 39, 93 Buttons Do Not Work When Pressed • 114 Chapter 6 Alarms and Messages • 99, 112, C 113 Changing Between Trend Views Chapter 7 • 78, 83 Troubleshooting • 99, 111 Changing Histogram Settings • Chapter 8 85 Specifications • 115 Changing Profiles • 51, 53, 94 Chapter 9 Changing Sensitivity Modes • 50 Service and
Radical-7 Index Docking Station Power Concepts of Alarm Response Requirements • 35 Delay • 135 Contacting Masimo • 113, 114, E 132 Electrical • 117, 129 Continuous Speaker Tone • 113 Environmental • 35, 117 Contraindications • 8 Estimated Run Times of Battery D Power • 128 Exclusions • 133 Deleting Trend Data • 88 Desat Index Alarm Overview • F 101, 102 FastSat Overview • 58 Desat Index Alarms • 102 Functional Oxygen Saturation Desat Index Settings • 102 (SpO2) • 18 Device Does Not Tu
Radical-7 Index Handheld Front Panel • 28, 122 General Description for Oxygen Saturation (SpO2) • 18 I General Description for In Vivo Adjustment Overview • Perfusion Index (PI) • 19 55, 58, 60, 66, 67 General Description for Pleth Variability Index (PVI) • 19 In Vivo for SpCO • 56, 66 General Description for Pulse In Vivo for SpHb • 56, 60 In Vivo for SpMet • 56, 67 Rate (PR) • 19 In Vivo for SpO2 • 56, 58 General Description for SpOC • 22 Incompatible Adhesive Sensor Message • 105 General
Radical-7 Index K Masimo rainbow SET® Parallel Engines • 17 Key Features • 7 Masimo SET® DST • 18 L Measurement Range • 115 Limitation of Warranty • 133 Messages • 43, 104 Limited Warranty • 132 Monitor Interface With SatShare Localization • 43, 71, 74, 113 • 34 Low Battery Message • 106 N Low Perfusion • 106, 112 Navigating the Main Menu • 52 Low Perfusion Index Message • Navigating the Radical-7 • 41 106 Near Expiration Message • 109 Low Signal IQ Message • 107 No Adhesive Sensor Co
Radical-7 Index P PR Alarms • 60 Parameter Quick Trend View • PR Settings • 54, 60 47 Product Description • 7 Parameter Settings • 53, 54 Profiles Overview • 43, 93, 96 Parameter Visualization Table • Pulse Bar • 45 91 Pulse CO-Oximetry vs.
Radical-7 Index S Recommended Separation Distances • 140 Safety Warnings and Cautions • Repair Policy • 131 9, 111 Replace Adhesive Sensor Sales & End-User License Message • 104 Agreement • 133 Replace Cable Message • 104 Screen Orientation • 71, 75 Replace Sensor Message • 104 Sensitivity Modes Overview • 43, 50, 96 Replacing Factory Default Settings for Adult and Neo Sensor • 24 Profiles • 96 Sensor Initializing Message • Replacing the Batteries • 128 108 Replacing the Fuses • 113, 12
Radical-7 Index Settings • 72 SpO2 Settings • 54, 56 Signal Extraction Technology SpO2 Values Do Not Correlate With Clinical Assessment or (SET) • 17 Arterial Blood Gas Signal IQ (SIQ) • 111 Measurements • 112 Signal IQ Indicators • 45, 46 SpOC Alarms • 68 Signal Processing • 25 SpOC Settings • 54, 68 Silencing the Alarms • 29, 39, Standalone • 31 96, 99 Standalone Back Panel • 33, 37, Sounds • 43, 53, 69, 73, 100 76 SpCO Alarms • 66 Standalone Front Panel • 32, 36 SpCO Reading Display
Radical-7 Index T V Testing with the optional Visualization • 90 Masimo SET Tester • 130 W Trend Field • 44, 53 Warnings and Cautions • 9, 21, Trends • 44, 53, 77 22, 23, 35, 99, 127 Troubleshooting Measurements Waveform and Trend Views • • 21, 23, 111 42, 46 Troubleshooting the Radical-7 • WiFi • 43, 71, 75 113 U Unexpected SpO2, SpCO, SpMet, or SpHb Reading • 112 Unexpectedly High SpCO Reading • 112 Unpacking and Inspection • 35 Using Screen Lock • 39 Using the Events Feature • 79 Using
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