Radius-7™ Wearable Pulse CO-Oximeter Operator's Manual
These operating instructions intend to provide the necessary information for proper operation of the Radius-7 Wearable Pulse CO-Oximeter. The Operator's Manual describes how Radius-7 information is displayed when used with Root, including display details as well as accessing and changing user-configurable settings. For additional information related to Root, refer to the Operator's Manual for Root. There may be information provided in this manual that is not relevant for your system.
Radius-7 Contents Contents About this Manual ------------------------------------------------------------------------------------------- 7 Product Description, Features and Indications for Use ---------------------------------------------- 9 Product Description ------------------------------------------------------------------------------------ 9 Indications for Use ------------------------------------------------------------------------------------- 9 Safety Information, Warnings and Cautions -----------
Radius-7 Contents Chapter 4- Operation -------------------------------------------------------------------------------------- 41 Using the Touchpad ----------------------------------------------------------------------------------- 41 About the Main Screen -------------------------------------------------------------------------------- 42 Navigating the Main Menu --------------------------------------------------------------------------- 42 Navigating Radius-7 Settings on Root ----------------------------
Radius-7 Contents Safety Checks ------------------------------------------------------------------------------------------- 82 Repair Policy -------------------------------------------------------------------------------------------- 83 Return Procedure -------------------------------------------------------------------------------------- 84 Contacting Masimo ------------------------------------------------------------------------------------ 84 Appendix ---------------------------------------------------
About this Manual This manual explains how to set up and use the Radius-7 Wearable Pulse CO-Oximeter. Important safety information relating to general use of the Radius-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.
Product Description, Features and Indications for Use Product Description The Radius-7 is a non-invasive device that measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and Pleth Variability Index (PVI®) along with optional measurements of hemoglobin (SpHb®), carboxyhemoglobin (SpCO®), total oxygen content (SpOC), methemoglobin (SpMet®), Acoustic Respiration Rate (RRa®) and Pleth Respiration Rate (RRp™).
Safety Information, Warnings and Cautions CAUTION: Radius-7 Wearable Pulse CO-Oximeter 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 Radius-7 if it appears or is suspected to be damaged. WARNING: Always use Radius-7 in conjunction with Root. Do not use parts from other systems.
Radius-7 Safety Information, Warnings and Cautions WARNING: To ensure safety, avoid placing anything on the device during operation. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: The Armband site must be checked frequently or per clinical protocol to ensure adequate securement, circulation and skin integrity.
Radius-7 Safety Information, Warnings and Cautions WARNING: SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). WARNING: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. WARNING: Inaccurate SpO2 readings may be caused by: • • • • • • • • Improper sensor application.
Radius-7 Safety Information, Warnings and Cautions • • • 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 oxygen saturation levels or elevated methemoglobin levels. WARNING: Inaccurate respiration rate measurements may be caused by: • • • • • www.masimo.com Improper sensor application. Low arterial perfusion. Motion artifact.
Radius-7 Safety Information, Warnings and Cautions CAUTION: Do not place the Radius-7 on electrical equipment that may affect the device, preventing it from working properly. CAUTION: Failure to charge Radius-7 promptly after a Low Battery alarm may result in the device shutting down. CAUTION: If using Radius-7 during full body irradiation, keep the sensor out of the radiation field.
Radius-7 Safety Information, Warnings and Cautions setting, false readings may occur due to environmental "noise" such as light, vibration, and excessive air movement. Cleaning and Service Warnings and Cautions WARNING: Do not attempt to reprocess, recondition or recycle the Radius-7 as these processes may damage the electrical components, potentially leading to patient harm. WARNING: Electric Shock Hazard: The battery in the Battery Module should not be removed from the Radius-7.
Radius-7 Safety Information, Warnings and Cautions television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
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.
Radius-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: • 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).
Radius-7 Chapter 1- Technology Overview General Description for Perfusion Index (PI) The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue. PI thus represents a non-invasive measure of peripheral perfusion that can be continuously and non-invasively obtained from a pulse oximeter. 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.
Radius-7 Chapter 1- Technology Overview rainbow Pulse CO-Oximetry Technology rainbow Pulse CO-Oximetry technology is governed by the following principles: 1. 2. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry).
Radius-7 Chapter 1- Technology Overview The Radius-7 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma. The Radius-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector).
Radius-7 Chapter 1- Technology Overview General Description for SpOC Oxygen (O2) is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The oxygen content calculated by the Pulse CO-Oximeter is referred to as SpOC and is measured in units of ml O2/dL blood. 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) x SpHb (g/dL) x SpO2 + 0.
Radius-7 Chapter 1- Technology Overview rainbow Acoustic Monitoring™ (RAM™) rainbow Acoustic Monitoring (RAM) continuously measures a patient’s respiration rate based on airflow sounds generated in the upper airway. The Acoustic Sensor, which is applied on the patient's neck, translates airflow sounds generated in the upper airway to an electrical signal that can be processed to produce a respiration rate, measured as breaths per minute.
Radius-7 Chapter 1- Technology Overview Acoustic Sensor The sensor captures respiratory sounds (and other biological sounds) much like a microphone does. When subjected to a mechanical strain, (e.g., surface vibrations generated during breathing), the sensor becomes electrically polarized. The degree of polarization is proportional to the applied strain.
Radius-7 Chapter 1- Technology Overview In Vivo Adjustment™ 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. In Vivo Adjustment for a parameter can be turned on by accessing the In Vivo screen in the settings menu of that parameter.
Radius-7 Chapter 1- Technology Overview Signal IQ® (SIQ) The display provides a visual indicator of the plethysmogram signal quality and an alert when the displayed SpO2 values are not based on adequate signal quality. The signal quality indicator displayed is called the Signal IQ. The Signal IQ can be used to identify the occurrence of a patient’s pulse and the associated signal quality of the measurement.
Radius-7 Chapter 1- Technology Overview Adaptive Threshold Alarm (ATA) The Adaptive Threshold Alarm (ATA) feature is an optional feature that helps reduce the frequency of non-actionable 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.
Radius-7 Chapter 1- Technology Overview Sensitivity Modes Three sensitivity levels enable a clinician to tailor the response of the Radius-7 to the needs of the particular patient situation. 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).
Chapter 2- System Components General System Description The Radius-7 Wearable Pulse CO-Oximeter system consists of the following components: 1. 2. 3. 4. Instrument Module Battery Module Armband Battery Charging Adapter The Battery module snaps onto the Instrument Module and together they can be strapped onto a patient's arm using the Armband. The Battery Charging Adapter docks onto the Root to function as both a charger and holder for the Radius-7. Sensor compatibility: Refer to www.masimo.
Radius-7 Chapter 2- System Components Ref. Feature Description 2 Contact Pins The pins provide a data and power connection to the Battery Module. 3 Key for Armband The key allows for proper positioning of the Armband used to secure Radius-7 to the patient. 4 rainbow SET Sensor Connector A rainbow SET sensors can be connected to Radius-7 via this connector. CAUTION: Refer to the Directions for Use for the sensor before applying it on patients. www.masimo.
Radius-7 Chapter 2- System Components Radius-7 Battery Module The Battery Module features a Display panel, Touchpad, Speaker and rechargeable lithium-ion battery. The Battery Module is designed to snap onto the Instrument Module. Front View Back View The following table describes the features of the Battery Module: Ref. Feature Description 1 Speaker Radius-7 is provided with a speaker to provide alarms in the event the communication to secondary display is lost.
Radius-7 Chapter 2- System Components Radius-7 Armband The Armband is used to secure Radius-7 to the patient. The Armband comes in three different sizes; small (11.9”), medium (16.4”) and large (25.4”). The Instrument Module and Armband are keyed so that they can only be connected properly in the right orientation. See Securing Radius-7 to Patient on page 37 in the Operator's Manual.
Chapter 3- Setup The following chapter contains information about setting up Radius-7 before use. Unpacking and Inspection To unpack and inspect the device perform the following steps: 1. 2. 3. Remove the device 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.
Radius-7 Chapter 3- Setup Charging the Radius-7 Battery Module Before use, the Radius-7 Battery Module needs to be fully charged. To charge the Battery Module for the first time perform the following steps: 1. 2. 3. 4. 5. 6. Attach the Battery Charging Adapter to the Root by aligning the bottom of the adapter with the two groves at the bottom of the docking interface on the Root and snap it in place. Ensure that the Root is powered on and connected to an AC power supply.
Radius-7 Chapter 3- Setup Securing Radius-7 to Patient Before securing Radius-7 onto the patient, make sure the Battery Module is sufficiently charged. Note: Safety Information, Warnings and Cautions should be read before use. See Chapter 2- System Components on page 31 in the Operator’s Manual for information on the different components. To secure the Radius-7 to a patient, follow the instructions below with the help of the visual aid: www.masimo.
Radius-7 Chapter 3- Setup 1. 2. Remove the Armband from the packaging. Slide the Instrument Module between the Armband fabric and the Armband plastic as shown in the figure above. 3. The shaped hole in the Armband plastic should fit over the matching key on the front side of the Instrument Module. Connect the Battery Module securing the Armband Adapter between the Battery Module and the Instrument Module. Select a site on the patient's arm to secure Radius-7.
Radius-7 Chapter 3- Setup Removing Radius-7 from Patient To remove the Radius-7 from a patient, perform the following steps: 1. 2. 3. 4. 5. 6. 7. 8. 9. Disconnect sensor(s) from the Instrument Module. Detach the end of the Armband strap from the Armband fabric. Un-thread Armband strap from Instrument Module slot and remove the Radius-7 from the patient’s arm. Press the Release Buttons on the Battery Module, and slide the Battery Module off of the Instrument Module.
Chapter 4- Operation Using the Touchpad The Touchpad on the Radius-7 is located below the display panel on the Battery Module. Note: The display panel is not a touch screen. Using the gestures described below, the user is able to view all parameters and measurements, navigate through menu options, and silence/acknowledge alarms on Radius-7. Action Description Function Touch Touch and release. Action Select a menu item or action performed once finger is released.
Radius-7 Chapter 4- Operation About the Main Screen The Main Screen is composed of the following: Ref Feature Description 1 Status Bar Visible at the top of the Main Screen and displays Exception Messages, Bluetooth connectivity status and battery life. 2 Parameter Display Majority portion of Main Screen. Displays up to four parameters simultaneously. 3 Waveform Field Displays SIQ and the pleth waveform with the respiration waveform (blue) in the background.
Radius-7 Chapter 4- Operation Navigating Radius-7 Settings on Root The following settings on Radius-7 can be configured with Root: • Sensitivity Mode settings • Parameter Alarm settings • In vivo settings • Additional settings including Averaging time and FastSat. The following section describes how Radius-7 settings may be configured with Root when connected via Bluetooth.
Radius-7 Chapter 4- Operation In the Rainbow menu select the Parameter tile to see all available parameters to be configured, and finally press any parameter tile to access the settings menu for that parameter. Each parameter’s settings menu may include the following options: Option Description About A brief explanation about the parameter. Alarms Configure high/low alarm limits, caution ranges for SpO2, Rapid Desat limit threshold, alarm delay, Adaptive Threshold Alarm.
Radius-7 Chapter 4- Operation SpO2 Settings About An informational read-only screen appears with an explanation about SpO2. Alarms Option Description Factory Default Configuration Options High Limit High Limit is the upper threshold that triggers an alarm. Off 2% to 99% in steps of 1%, or Off When set to Off, alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm.
Radius-7 Chapter 4- Operation Additional Settings Option Description Factory Default Configuration Options Averaging The length of time over which the system Time calculates the average of all data points. 8 seconds 2-4, 4-6, 8, 10, 12, 14 or 16 seconds FastSat Off On or Off Enable/disable FastSat feature for rapid tracking of oxygen saturation changes.
Radius-7 Chapter 4- Operation PI Settings About An informational read-only screen appears with an explanation about PI. Alarms Option Description Factory Default Configuration Options High Limit High Limit is the upper threshold that triggers an alarm. Off Step size: 0.04 to 0.09 in steps of 0.01 0.10 to 0.90 in steps of 0.10 1 to 19 in steps of 1, or Off Low Limit Low Limit is the lower threshold that triggers an alarm. Off Step size: 0.03 to 0.09 in steps of 0.01 0.10 to 0.90 in steps of 0.
Radius-7 Chapter 4- Operation PVI Settings About An informational read-only screen appears with an explanation about PVI. Alarms Option Description Factory Default High Limit High Limit is the upper threshold that Off triggers an alarm. 2 to 99 in steps of 1, or Off Low Limit Low Limit is the lower threshold that triggers an alarm. 1 to 98 in steps of 1, or Off Off Configuration Options When set to Off, alarms are disabled. When set to Off, alarms are disabled.
Radius-7 Chapter 4- Operation SpHb Settings About An informational read-only screen appears with an explanation about SpHb. Alarms Option Description Factory Default Configuration Options High Limit High Limit is the 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 to the nearest whole number.
Radius-7 Chapter 4- Operation Additional Settings Option Description Factory Default Configuration Options Averaging Time The length of time over which the system calculates the average of all data points. Medium Short, Medium, or Long Calibration Provides an arterial or venous value that displays on the main screen. Venous Arterial or Venous Precision Allows the user to set the decimal for SpHb. 0.1 0.1, 0.5, or 1.
Radius-7 Chapter 4- Operation SpCO Settings About An informational read-only screen appears with an explanation about SpCO Alarms Option Description Factory Default High Limit High Limit is the upper threshold that 10 triggers an alarm. Configuration Options 2% to 98%, in steps of 1%, or Off When set to Off, alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm. Off 1% to 97%, in steps of 1%, or Off When set to Off, alarm is disabled.
Radius-7 Chapter 4- Operation SpMet Settings About An informational read-only screen appears with an explanation about SpMet Alarms Option Description Factory Default High Limit High Limit is the upper threshold that 10 triggers an alarm. Configuration Options 1% to 2%, in steps of 0.1%, 2.5% to 99.5% in steps of 0.5%, or Off When set to Off, alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm. Off 0.1% to 2%, in steps of 0.1% 2.5% to 99%, in steps of 0.
Radius-7 Chapter 4- Operation SpOC Settings About An informational read-only screen appears with an explanation about SpOC Alarms Option Description Factory Default High Limit High Limit is the upper threshold that Off triggers an alarm. Configuration Options 2% to 34%, in steps of 1%, or Off When set to Off, alarm is disabled Low Limit Low Limit is the lower threshold that triggers an alarm. Off 1% to 33%, in steps of 1%, or Off When set to Off, alarm is disabled.
Radius-7 Chapter 4- Operation RRa Settings When using an acoustic sensor, respiration rate (RR) is determined by the acoustic (RRa) signal. See rainbow Acoustic Monitoring™ (RAM™) on page 25 of the Operator's Manual. When the respiratory rate is determined by the acoustic signal, RRa alarms and RRa settings are active, and the parameter label displays as RRa. RRa is active under the following conditions: • RRa is installed on Radius-7. • Acoustic sensor is connected.
Radius-7 Chapter 4- Operation Option Description Freshness The duration of time that, during 5 minutes interference, the system displays the last valid reading. www.masimo.
Radius-7 Chapter 4- Operation RRp Settings When using a pulse oximetry or pulse CO-Oximetry sensor with Radius-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. When using a pulse oximetry or pulse CO-Oximetry sensor, RRp alarms and RRp settings are active and the parameter label displays as RRp.
Radius-7 Chapter 4- Operation Option Description Freshness The duration of time that, during 5 minutes interference, the system displays the last valid reading. www.masimo.
Chapter 5- Alarms and Messages About Alarms The Radius-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.
Radius-7 Chapter 5- Alarms and Messages Alarm Management In order to minimize accidental changes to Radius-7's critical settings, alarm management is restricted to Root. When Radius-7 is connected to Root, audible alarms will sound on Root but not Radius-7. In this case, audible alarms can be temporarily silenced on Root. Visual alarms will display on both Radius-7 and Root until the alarm condition has been addressed. For alarm management on Root, see Operator’s Manual for Root.
Radius-7 Chapter 5- Alarms and Messages Messages The following section lists common messages, their potential causes, and next steps. Alarm Message Description Next Step Low battery Battery charge is low. Charge Battery Module by docking into Battery Charging Adapter on Root and powering Root with AC line power. Replace Battery Module if necessary. Device disconnected Device has lost Bluetooth connectivity with Root. Check if Bluetooth is enabled on Root. See the Operator's Manual for Root.
Radius-7 Chapter 5- Alarms and Messages Alarm Message Description Next Step • (Pulse CO-Ox) Replace Adhesive Sensor, or • (RAM) Replace Adhesive Sensor • (Pulse CO-Ox) Defects in the Instrument Module Replace Cable, or • (RAM) Replace Cable • (Pulse CO-Ox) Incompatible Adhesive Sensor, or • (RAM) Incompatible Adhesive Sensor • (Pulse CO-Ox) No Adhesive Sensor Connected, or • (RAM) No Adhesive Sensor Connected • (Pulse CO-Ox) Interference Detected, or • (RAM) Interference Detected (P
Radius-7 Chapter 5- Alarms and Messages Alarm Message Description Next Step (Pulse CO-Ox) Low Signal IQ Low signal quality. Ensure proper sensor application. Move sensor to a better perfused site. See Signal IQ® (SIQ) on page 28 of the Operator’s Manual. Low SpCO SIQ message SpCO measurement reading is obscured. Ensure proper sensor application. Check sensor to see if it is working properly. If not, replace the sensor. Low SpMet SIQ message SpMet measurement reading is obscured.
Radius-7 Chapter 5- Alarms and Messages Alarm Message Description Next Step (Pulse CO-Ox) Sensor Device is checking the sensor for proper functioning and performance. If values are not displayed within 30 seconds, disconnect and reconnect sensor. If values are still not displayed, replace with a new sensor. Initializing • (Pulse CO-Ox) Sensor Off Patient, or Sensor off patient. Disconnect and reconnect sensor. Reattach sensor.
Chapter 6- Troubleshooting Troubleshooting Measurements Symptom Potential Causes Low signal quality. Sensor is damaged or not functioning. Next Steps • Verify Sensor type and size and re-apply sensor. See Directions for Use for Sensor. • Check and see if blood flow to the site is restricted. • Check the placement of the sensor. Re-apply sensor or move to a different site. • Replace Sensor. • Minimize or eliminate motion at the monitoring site. • Set to Maximum Sensitivity.
Radius-7 Chapter 6- Troubleshooting Symptom Potential Causes SpCO reading displays as dashes. SpCO parameter may have not stabilized. Next Steps • Allow time for parameter reading to stabilize. • Verify Sensor type and size and re-apply sensor. See Directions for Use for Sensor. • Check and see if blood flow to the site is restricted. • Check the placement of the sensor. Re-apply sensor or move to a different site. • Replace Sensor.
Radius-7 Chapter 6- Troubleshooting Symptom Potential Cause Unable to pair with Root Bluetooth not enabled on Root. Next Step 1. 2. Internal failure. 3. 4. 5. www.masimo.com Check if Bluetooth is enabled on Root. See the Operator's Manual for Root. Check if Bluetooth is enabled on Radius-7 by accessing the About panel on the Main Menu. See Connecting Radius-7 to Root via Bluetooth on page 36 of the Operator's Manual. Verify the Mac address on Radius-7 matches the one on Root.
Chapter 7- Specifications 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.
Radius-7 Chapter 7- Specifications Motion [3] (SpO2 from 70% to 100%) Adults, Pediatrics 3% Low perfusion [4] (SpO2 from 70% to 100%) Adults, Pediatrics 2% Pulse Rate (PR) Range 25 to 240 bpm No motion Adults, Pediatrics 3 bpm Motion [5] Adults, Pediatrics 5 bpm Low Perfusion Adults, Pediatrics 3 bpm Carboxyhemoglobin Level (SpCO) [1] Range of 1% to 40% Adults, Pediatrics 3% Methemoglobin Level (SpMet) [1] Range 1% to 15% Adults, Pediatrics 1% Total Hemoglobin SpHb [6] Range of 8 g/dL to 1
Radius-7 Chapter 7- Specifications Parameter Resolution SpHb g/dL 0.
Radius-7 Chapter 7- Specifications Physical Characteristics Item Description x 2.8 ” x 1.2” Dimensions 5.1” (130 mm x 70 mm x 30 mm) Weight 0.34lbs. (155g) 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 to 69 breaths per minute PI 0.
Radius-7 Chapter 7- Specifications Display Indicators Item Description Trend Memory Max of 6 hours at 2-second resolution Display Update Rate 1 second Response Time < 30 second delay Type OLED Pixels 160 X 128 Dot Pitch 0.073 (W) mm X 0.219 (H) mm EMC Compliance EMC Compliance IEC 60601-1-2:2007, Class B Safety Standards Compliance Safety Standards Compliance ANSI/AAMI ES 60601-1:2005 CAN/CSA C22.2 No.
Radius-7 Chapter 7- Specifications Equipment Classification per IEC 60601-1 Type of Protection Internally powered (battery powered) Degree of Protection against Electrical Shock Defibrillation Proof Type BF-Applied Part Protection against harm from Water and Particulate Matter IP24 (Protection from solid foreign objects ≥12.
Radius-7 Chapter 7- Specifications Guidance and Manufacturer's Declaration- Electromagnetic Emissions Guidance and Manufacturer's Declarations - Electromagnetic Emissions The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment - Guidance RF Emissions Group 1 ME Equipment uses RF energy only for its internal function.
Radius-7 Chapter 7- Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity 80 MHz to 800 MHz 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 lessb than the compliance level in each frequency range .
Radius-7 Chapter 7- Specifications Recommended Separation Distances Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Radius-7 Chapter 7- Specifications Symbols Symbol Description Follow Instructions for Use. See Instructions for Use. Separate collection for electronic waste. Mark of conformity to European Medical Device Directive 93/42/EEC. Federal law restricts this device to sale by or on the order of a licensed physician. Authorized Representative in the European Community Storage Humidity range: 10% to 95% or 15% to 95%. Storage temperature range: +70° C to -40° C or -20° C to 50° C.
Radius-7 Symbol Chapter 7- Specifications Description Non-sterile. Defibrillation proof Type BF. IP24 Protection from ingress and particulate matter. Catalog number (model number). Serial Number. UL, LLC. Certification. Non-ionizing electromagnetic radiation. Federal Communications Commission (FCC) licensing. Wireless features can be used in member states with the restriction of indoor use in France. IC Model Industry Canada Registered Model. www.masimo.
Radius-7 Chapter 7- Specifications Citations [1] SpO2, SpCO, and SpMet accuracy was determined by testing on healthy adult male and female 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 weighing between 0.5 kg and 4.25 kg. Seventy-nine data samples were collected over a range of 70% to 100% SaO2 and 0.5% to 2.
Chapter 8 - Service and Maintenance The following chapter contains information about cleaning, battery operation, performance verification, service, repair, and warranty. Cleaning The Radius-7 is a reusable device. The device is supplied and used non-sterile. The Radius-7 should be cleaned before and after it has been applied to a patient and/or in accordance with local and governmental regulations to minimize the risk of cross-contamination.
Radius-7 Chapter 8 - Service and Maintenance Battery Operation and Maintenance The Radius-7 includes a Battery Module containing a lithium ion rechargeable battery. Before using the Radius-7, the Battery Module should be fully charged. See Charging the Radius-7 Battery Module on page 36 of the Operator's Manual. The Battery Module requires approximately 6 hours for charging. Memory effects of the battery may shorten run-time.
Radius-7 Chapter 8 - Service and Maintenance Speaker, Display and Touchpad Function Test To conduct a Speaker, Display and Touchpad Function Test 1. 2. 3. Snap the Battery Module onto the front side of the Instrument Module. Upon connection, verify the Radius-7 emits a tone and the Masimo logo is displayed on the screen. Follow instructions for using the Touchpad. See Using the Touchpad on page 41 of the Operator's Manual. Alarm Limit Test To conduct an Alarm Limit Test 1. 2. 3. 4. 5. 6.
Radius-7 Chapter 8 - Service and Maintenance Return Procedure Clean contaminated/dirty equipment before returning, following instructions in Cleaning on page 81. 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.
Radius-7 Chapter 8 - Service and Maintenance Exclusions The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or maintenance needed because of: a) modification of the Product or Software without Masimo’s written authorization; b) supplies, devices or electrical work external to the Product or not manufactured by Masimo; c) disassembly or reassembly of the Product by anyone other than an authorized Masimo agent; d) use of the Product with Sensors or other accessories othe
Radius-7 3. 4. Chapter 8 - Service and Maintenance Purchaser may not disclose, publish, translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Software or the written materials. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis.
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.
Radius-7 Appendix 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 80601-2-61. www.masimo.
Configuring Parameters • 43 Configuring Sensitivity Modes • 43 Connecting Radius-7 to Root via Bluetooth • 36, 43, 67, 83 Contacting Masimo • 61, 66, 84 Index A About Alarms • 59 About the Main Screen • 42 About this Manual • 7 Accuracy • 69 Acoustic Sensor • 26 Acquisition System • 26 Adaptive Threshold Alarm (ATA) • 29, 44, 45 Alarm Limit Test • 83 Alarm Management • 60 Alarm Priorities • 59 Alarms • 72 Appendix • 87 D Display Indicators • 73 E Electrical • 71 EMC Compliance • 73 Environmental • 71 Exc
Radius-7 Index Guidance and Manufacturer's Declaration- Electromagnetic Immunity • 75 Radius-7 Battery Module • 33 Radius-7 Instrument Module • 31 rainbow Acoustic Monitoring Architecture • 25 rainbow Acoustic Monitoring™ (RAM™) • 25, 54 rainbow Pulse CO-Oximetry Technology • 22 Recommended Separation Distances • 77 Removing Radius-7 from Patient • 39 Repair Policy • 83 Resolution • 70 Respiration Rate Settings • 53 Restrictions • 85 Return Procedure • 83, 84 RRa Settings • 54 RRp Settings • 56 I In Viv
Radius-7 Index Successful Monitoring for SpO2, PR and PI • 20 Symbols • 78 T Troubleshooting Measurements • 65 Troubleshooting Radius-7 • 66 U Unpacking and Inspection • 35 Using the Touchpad • 41, 83 W Warranty • 84 www.masimo.
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