Masimo Radical Operator's Manual
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Masimo Radical Operator's Manual

Masimo Radical Operator's Manual

Signal extraction pulse oximeter
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O P E R A T O R ' S
M A N U A L

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  • Page 1 S i g n a l E x t r a c t i o n P u l s e O x i m e t e r O P E R A T O R ’ S M A N U A L...
  • Page 2 The Radical Operating Instructions are intended to provide the necessary information for proper operation of all models of the Radical pulse oximetry system. There may be information provided in this manual that is not relevant for your system. General knowledge of pulse oximetry and an understanding of the features and functions of the Radical Pulse Oximeter are a prerequisite for proper use.
  • Page 3 SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES The Radical Signal Extraction Pulse Oximeter is designed to minimize the possibility of hazards from errors in the software program by following sound engineering design processes, Risk Analysis and Software Validation. Explosion hazard. Do not use the pulse oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.
  • Page 4 ❚ Increase the separation between the equipment. ❚ Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. ❚ Consult the manufacturer for help. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 5: Table Of Contents

    Unpacking and Inspection ......................15 Preparation for Monitoring ......................15 Radical Power Requirements ..................15 Initial Battery Charging ....................16 Initial Installation ......................16 Monitor Setup..........................17 SatShare Setup ..........................18 HP VueLink Setup ........................20 Spacelabs Universal Flexport Setup ..................20 Radical Signal Extraction Pulse Oximeter Operator’s Manual...
  • Page 6 Pulse Rate Low Limits (BPM) ................30 Type of Limits ......................30 Silence ........................31 Level ........................31 Display ............................32 View ........................32 Pleth + Signal IQ View ..................32 Pleth Only ......................32 Numbers ......................32 Contrast........................32 Language ........................32 General............................33 Averaging Time ......................33 FastSat ........................33 Radical Signal Extraction Pulse Oximeter Operator’s Manual...
  • Page 7 Second Page....................38 Third Page......................38 Trend Setup......................39 %SpO High Scale ..................39 %SpO Low Scale ..................39 PR High Scale (BPM) ..................39 PR Low Scale (BPM) ..................39 Default View ....................39 Trend Action ....................39 Trend Period ......................40 Radical Signal Extraction Pulse Oximeter Operator’s Manual...
  • Page 8 Selecting a Masimo LNOP Sensor ................54 Cleaning and Reuse of Masimo LNOP Sensors ............55 Reattachment of Single Use Adhesive Sensors ............55 Masimo SET Patient Cables ......................56 Cleaning and Reuse of Masimo SET Patient Cables ..........56 Radical Signal Extraction Pulse Oximeter Operator’s Manual...
  • Page 9 Battery Operation and Maintenance ..................58 Replacing the Batteries ..................60 Replacing the Fuses....................61 Performance Verification ......................61 Service and Repair ........................65 Repair Policy......................65 Return Procedure ....................65 Warranty ............................66 Exclusions ..........................66 SECTION 10 / ACCESSORIES Accessories ......................67 Radical Signal Extraction Pulse Oximeter Operator’s Manual viii...
  • Page 10 Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 11: About This Manual

    This manual explains how to set up and use the Radical Pulse Oximeter. Important safety information relating to general use of the Radical Pulse Oximeter appears before this introduction. Other important safety information is located throughout the manual where appropriate.

  • Page 12: Warnings, Cautions And Notes

    Sample of Caution: CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A NOTE is provided when extra general information is applicable. Sample of Note: NOTE: This is a sample of a Note. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 13: Product Description

    The Radical Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. Radical can be used as either a Handheld or a Standalone monitor. Radical features a backlit Liquid Crystal Display (LCD) that continuously displays numeric values...

  • Page 14: Pulse Oximetry

    (for example a fingertip, a hand, a foot) and measuring changes in light absorption during the pulsatile cycle. See figure below. The Radical utilizes a sensor with red and infrared light-emitting diodes (LEDs) that pass light through the site to a photodiode (photodetector).

  • Page 15: Functional Vs. Fractional Saturation

    (sometimes referred to as noise). Masimo SET pulse oximetry utilizes adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components.

  • Page 16: Introduction

    CAUTIONS: THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL. REFER TO THE RADICAL DISPLAY FOR PATIENT WAVEFORM. IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR *Contact Masimo for the latest list of SatShare validated multiparameter monitors.

  • Page 17: Radical Handheld

    The Handheld Radical provides most of the functionality of the pulse oximeter. All user input and displays are controlled by this part of the Radical system. The sensor cable connects into the swivel connector on the Handheld unit.The Handheld is battery powered and can be used either as a transport monitor or as a Handheld Pulse Oximeter for spot checks.
  • Page 18 SET processing is active. FastSa FastSat The FastSat symbol is shown on the Radical display whenever the Radical is set to operate in the FastSat mode. Saturation The Saturation Alarm Limits Display shows the upper and lower saturation Alarm Limits alarm limits.
  • Page 19 The Output Mode Indicator also displays the type of SatShare cable. The Indicator Output Mode indicator is only displayed when the Radical device actively outputs data other than ASCII text, or interfaces with a monitor through the SatShare cable. Press the Power/Standby Button to turn the instrument on. Press, hold the...

  • Page 20: Handheld Back Panel

    Use of the Pole Clamp accessories for attachment instructions. Accessory Holder Battery Cover The Radical Handheld is powered by a NiMH battery located in this compartment. For battery care and replacement please see Section 9, Replacing the Batteries. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 21: Radical Standalone

    When the Radical Handheld is placed into the Docking Station, the Radical becomes a full-featured standalone device. The Radical Standalone acts as a battery charger for the Handheld device and has AC power connection capabilities.

  • Page 22: Standalone Front Panel

    The Docking Indicator is illuminated when the Handheld unit is turned on and Indicator is properly interfaced to a Docking Station. NOTE: When the Radical Standalone is turned on, all indicator LEDs initially turn on and off at start up. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 23: Standalone Back Panel

    Use the Serial Output Connector to connect a serial device, including a serial Connector printer or PC, to the Radical. The data is provided in standard RS-232C format. See Section 7, Serial Interface Specifications. All external device connections to the Serial Output Connector must be IEC-60950 compliant.

  • Page 24: Symbols

    SYMBOLS The following symbols are found on the back of the Radical Docking Station, they are defined below: SYMBOLS RS-232 SatShare interface Equipotential Ground Terminal...

  • Page 25: Introduction

    - u p i n t r o d u c t i o n Before the Radical Pulse Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be fully charged.

  • Page 26: Initial Battery Charging

    Place the Docking Station on a stable hard flat surface near the patient. Always place the Radical unit on a dry surface. Maintain a minimum of 3 cm (1 inch) free space around the Radical Standalone unit. Make sure that Radical loudspeaker is not covered to avoid a muffled alarm sound.

  • Page 27: Monitor Setup

    LCD SCREEN ILLUMINATION (AC power) Illumination set to maximum, level 4 LCD SCREEN ILLUMINATION (battery power) Illumination set to off The following table outlines the type of settings that the user can change and Radical will remember after a power cycle. OPTION...

  • Page 28: Satshare Setup

    The Radical Pulse Oximeter has been proven to be accurate during patient motion and low perfusion conditions. Saturation and pulse rate values from the Radical may be displayed on a multiparameter monitor through the SatShare feature.
  • Page 29 Power Save parameter in the General menu to "No", refer to Section 4, Operation. Please note that if the Radical is used in this mode, the length of time the Radical can operate on battery power will be significantly diminished.

  • Page 30: Hp Vuelink Setup

    Select the HP VueLink selection from the Output menu on the Radical. Refer to Section 4, Output. Connect one end of the VueLink cable to the Serial Output connector on the back of the Docking Station.

  • Page 31: Introduction

    To operate the Masimo SET Radical Pulse Oximeter effectively, the device must be set up properly, and the operator must: Know how the pulse oximeter derives its readings (see Section 1, Pulse Oximetry).
  • Page 32 17. After monitoring is complete, remove the sensor from the patient and store or dispose of the sensor according to governing rules. See the Directions for Use of the sensor. 18. Press and hold the Power/Standby Button for 2 seconds to turn the oximeter off. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 33: Successful Spo 2 Monitoring

    Very low hemoglobin levels. NUMERIC DISPLAY - PULSE RATE The Pulse Rate displayed on the Radical may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation. Significant differences may indicate a problem with the signal quality due to physiological changes in the patient or one of the instruments or application of the sensor or patient cable.The pulsations from intra-...

  • Page 34: Signal Iq

    The signal quality indicator displayed on the Radical 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.

  • Page 35: Low Perfusion

    LOW PERFUSION The Radical displays an indicator (i.e., “Low Perfusion” message) when there are very low amplitude arterial pulsations. It has been suggested that at extremely low perfusion levels, pulse oximeters can measure peripheral saturation, which may differ from central arterial saturation .

  • Page 36: Touch Key Control Buttons And Icons

    Handheld display.To select a touch key icon, press and release the dark gray control button to the right of the icon. On the Radical display, four icons are shown on the right side or bottom of the LCD display. FIRST PAGE Next Menu Press the Next Menu Page button to access the second page of selections.

  • Page 37: Navigating The Main Menu

    Once a parameter is highlighted, edit the parameter by pressing the Edit Parameter icon. Select the Next icon to scroll through the parameters without selecting them. NEXT Once a parameter is highlighted, edit the parameter by pressing the Edit Parameter icon. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 38: Editing A Parameter

    % SpO high/low limit Pulse rate high/low limit (bpm) ALARMS Type of alarm limits Silence Level View DISPLAY Contrast Language Averaging Time FastSat Home Use GENERAL Interface Alarms SatShare Numbers Power Save Radical Signal Extraction Pulse Oximeter Operator’s Manual...
  • Page 39 Time (hour/minute) Time display format CLOCK Date (day/month/year) Date display format ABOUT Software Version Serial Mode OUTPUT Analog Output Mode Handheld Battery Deep Discharge SERVICE DS Battery Deep Discharge Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 40: Alarms

    TYPE The Radical stores three types of alarm limits: Adult, Neo or OF LIMITS Custom limits. Adult and Neo limits are preset and cannot be changed by the user. The following table outlines the default values of the preset and custom alarm limits.

  • Page 41: Silence

    NOTE: The alarm silence period is reset to 120 seconds upon power cycle, except for when the Radical is set to operate in the Home mode. ALL MUTE All patient alarm conditions are silenced. Only system alarms will be indicated by an audible alarm.

  • Page 42: Display

    1 to 64. NOTE: The contrast can also be set by pressing and holding the Backlight/ Contrast Button on the front panel. Allows the user to select the language displayed on the screen. LANGUAGE Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 43: General

    4 seconds averaging mode, the FastSat algorithm is automatically enabled. HOME USE Set the Radical to the Home Mode.The Radical will remain in the Home Mode until the “No” setting is selected. A password is required to activate or deactive this mode. See Section 4, Home Use Operation, for a detailed description.

  • Page 44: About

    This displays the copyright and software versions of the Handheld and Docking Station. o u t p u t Note: The output menu selections are only available when the Radical Handheld is interfaced to the Docking Station. MENU ITEMS DESCRIPTION SERIAL MODE The following serial output modes are supported.

  • Page 45: Service

    PULSE OXIMETER IS CONNECTED TO THE AC MAIN POWER SUPPLY. s e r v i c e NOTE: The Service menu selections are only available when the Radical Handheld is interfaced to the Docking Station. Only qualified Biomedical or Clinical Engineering department personnel should access the service menu.

  • Page 46: Trend Display

    Depending on the Trend Period, a setting for how often the data is stored in the trend memory, the Radical can store between 72 hours and 30 days worth of trend data. The Radical also employs a sophisticated data compression scheme. The actual amount of trend data that is stored is dependent on the type of data that is collected.
  • Page 47 2 hours, the trend display will time out after 1 minute of inactivity (i.e. the user does not press any of the touch key control buttons) and the normal Radical display will be shown. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 48: Navigating Trend Display

    Press the Histogram button to display the selected data set (the data set shown in Histogram the trend view) in histogram format. Press the clear Trend Data button to clear the data stored in the trend memory. Clear Trend Data Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 49: Trend Setup

    SpO and pulse rate measurement. Each trend record is printed on a single line, followed by a carriage return and line feed character. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 50: Trend Period

    2 seconds, resulting in a minimum trend capacity of 72 hours. A setting of 10, for example sets the Radical to store one set of data points every 10 seconds, resulting in a typical trend storage capacity of 30 days.
  • Page 51 The user can access the menu system. If the SatShare cable is connected to the Radical only, and not to a patient monitor, the SatShare cable type is flashing on the LCD screen.

  • Page 52: Home Mode Operation

    NOTE: When the Radical is set to operate in the Home mode the default values that the Radical reverts to after a power cycle are set according to Section 3, Monitor Setup, with the exception of the Alarm Silence setting, which is set to the pre-power down setting.

  • Page 53: Introduction

    The Radical Pulse Oximeter visually and audibly indicates alarm conditions that the system detects. The integrated loudspeaker indicates alarm conditions audibly. The LCD screen and the LED lights on the Docking Station indicate the visual alarms.
  • Page 54 For averaging modes of less than 14 seconds, the Radical indicates saturation and pulse rate alarms within 3 seconds of when the alarm condition is met. For averaging modes of 14 and 16 seconds, the Radical indicates saturation and pulse rate alarms within 10 seconds of when the alarm condition is met.

  • Page 55: Alarm Operation

    Move sensor to better perfused site. Refer to Section 4, Low Perfusion. LOW SIGNAL IQ Low signal quality. Ensure proper sensor application. Move sensor to a better perfused site. Refer to Section 4, Signal IQ. Radical Signal Extraction Pulse Oximeter Operator’s Manual...
  • Page 56 SENSOR OFF Sensor off patient. Disconnect and reconnect sensor. Reattach sensor. SERVICE * Internal Failure. Unit requires service. REQUIRED * The SERVICE REQUIRED message fills the entire display. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 57: Troubleshooting

    The following chart describes what to do if the Radical system does not operate properly or fails.

  • Page 58: Radical Specifications

    55 VA Fuses: 1 Amp, Fast Acting, Metric, (5x20mm), 250V batteries Handheld: Type: NiMH Capacity: 4 hours Charging time: 3 hours Docking Station (RDS-1B, RDS-3B): Type: NiMH Capacity: 12 hours Charging time: 6 hours Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 59: Environmental

    Pixels: 480 x 160 dots Dot Pitch: 0.25 mm output interface SatShare (RDS-1, RDS-1B), Serial RS-232, Analog Output, Nurse Call (RDS-1, RDS-1B, RDS-3, RDS-3B) HP Vuelink, Spacelabs Universal Flexport (RDS-1, RDS-1B, RDS-3, RDS-3B) Radical Signal Extraction Pulse Oximeter Operator’s Manual...

  • Page 60: Serial Interface Specifications

    Continuous 1 The Masimo SET Radical Pulse Oximeter with LNOP Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO 2 against a laboratory co-oximeter and ECG monitor.

  • Page 61: Serial Interface Setup

    SERIAL INTERFACE SETUP: To interface with the Radical serial port, set the following communication parameters on the interfacing serial device: PARAMETER SETTING BAUD RATE 9600 Baud bi-directional...

  • Page 62: Analog Output/Nurse Call Specifications

    The Analog Out and Nurse Call are features accessible on the same female high density DB-15 connector. NOTE: The Radical analog output / nurse call interface is only available when the Radical Handheld is properly attached to the Radical Docking Station.

  • Page 63: Analog Output

    The nurse call feature is available when Radical is operating in its standalone configuration. The nurse call feature on the Radical Pulse Oximeter is based on the relay closing or opening depending on alarm events. For maximum flexibility, either normally open (pin 6) or normally closed (pin 7) signals are available.

  • Page 64: Introduction

    / p a t i e n t c a b l e s i n t r o d u c t i o n This section covers the use and cleaning of Masimo LNOP sensors and Masimo SET patient cables. ®...

  • Page 65: Cleaning And Reuse Of Masimo Lnop Sensors

    NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly positioned. Reposition the sensor or choose a different monitoring site. WARNING: TO AVOID CROSS CONTAMINATION ONLY USE MASIMO LNOP SINGLE USE SENSORS ON THE SAME PATIENT.

  • Page 66: Masimo Set Patient Cables

    Reusable patient cables of various lengths are available. All cables that display the Masimo SET logo are designed to work with any Masimo LNOP sensor and with any pulse oximeter or multiparameter instrument displaying the Masimo SET logo.

  • Page 67: Introduction

    This chapter covers how to test the operation of the Radical and the SatShare interface, how to properly clean the Radical pulse oximeter, how to recharge and replace the batteries, how to replace the fuses, and how to obtain service.

  • Page 68: Battery Operation And Maintenance

    The Radical Handheld includes a 1.5 Amp-Hour Nickel Metal Hydride battery. The Radical Docking Station may include the optional 6.5 Amp-Hour Nickel Metal Hydride battery. Before using the Radical as a Handheld or transport monitor, the Handheld battery and the optional Docking Station battery need to be fully charged.
  • Page 69 The following tables outline the estimated run times of the battery powered Radical Pulse Oximeter.The time estimates are based on a Radical with fully charged batteries.The time estimates are also based on a Radical with and without backlight lit, and the power save feature enabled and disabled.

  • Page 70: Replacing The Batteries

    To replace the Handheld battery, follow these instructions: Turn the Radical Handheld off and remove the patient cable connection. Detach the Radical Handheld from the Docking Station (if docked). Loosen the closure screw on the battery compartment door and lift off the battery compartment door cover.

  • Page 71: Replacing The Fuses

    To test the performance of the Radical pulse oximeter following repairs or during routine maintenance, follow the procedure outlined in this section. If the Radical fails any of the described tests, discontinue its use and correct the problem before returning the unit back to the user.
  • Page 72 Key Press Button Test: With the exception of the Power/Standby Button, press each soft key button and verify that the Radical acknowledges each key-press with an audible beep tone or by indicating a change on the display. Alarm Limit Test: With the monitor turned on, select the Menu Access key and enter the Alarm menu.
  • Page 73 Connect the Masimo SET Tester to the Patient Cable Connecter. Verify that within 20 seconds a plethysmographic and a Signal IQ waveform displays. (may require the Radical to be set to the Pleth and Signal IQ display setting). Verify that the SpO measurement is between 79% and 84%.
  • Page 74 Connect the common lead of a digital voltmeter to the pin 2 (Ground) of the analog output connector on the Radical. Connect the positive lead of the voltmeter to pin 9 (Analog Out - % SpO ) of the analog output connector.

  • Page 75: Service And Repair

    Section 9, Cleaning. Make sure it is fully dry before packing the equipment. To return the Radical unit for service, please follow the Return Procedure. RETURN PROCEDURE Please clean contaminated/dirty equipment before returning and make sure it is fully dry before packing the equipment.

  • Page 76: Warranty

    / m a i n t e n a n c e w a r r a n t y Masimo warrants to the initial purchaser that each new pulse oximeter will be free from defects in workmanship or materials for a period of three (3) years from the date of purchase.

  • Page 77: Section 10 / Accessories

    The following accessories and re-order parts are available with the Radical Signal Extraction pulse oximeter: ACCESSORIES PART NUMBER...
  • Page 78 SATSHARE CABLE-DS02 1539 SATSHARE CABLE-HP01 1320 SATSHARE CABLE-MQ01 1321 SATSHARE CABLE-NK01 1367 SATSHARE CABLE-OH01 1366 SATSHARE CABLE-SL01 1323 SATSHARE CABLE-SL02 1362 SATSHARE CABLE-SM01 1322 Please visit our website, www.masimo.com, for updated information about accessories. Radical Signal Extraction Pulse Oximeter Operator’s Manual...

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