signal extraction pulse co-oximeter OPERATOR’S MANUAL Contains: Oxyhemoglobin, Carboxyhemoglobin and Methemoglobin parameters
Signal Extraction Pulse CO-Oximeter OPERATOR’S MANUAL
The Radical-7 Pulse CO-Oximeter Operating Instructions provide the necessary information for proper operation of all models of the Radical-7 Pulse CO-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-7 Pulse CO-Oximeter are a prerequisite for its proper use.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES The Radical-7 Signal Extraction Pulse CO-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.
table of contents SECTION 1 - OVERVIEW About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Warnings, cautions and notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
table of contents SECTION 5 - ALARMS AND MESSAGES System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3D Alarm System Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3D Alarm System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
overview 1 About This Manual This manual explains how to set up and use the Radical-7 Pulse CO-Oximeter containing Masimo Rainbow SET technology. Important safety information relating to general use of the Pulse CO-Oximeter appears before this introduction. Other important safety information is located throughout the manual where appropriate. Read the entire safety information section before you operate the monitor.
1 overview Warnings, cautions and notes Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a gray shaded box. Sample of Warning: WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.
1 overview Pulse CO-Oximetry PRINCIPLE OF OPERATION SpO2 GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for neonates. The sensor is connected to the Pulse CO-Oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument.
1 overview 1 overview FUNCTIONAL SATURATION MASIMO RAINBOW SET PARALLEL ENGINES The Radical-7 is calibrated to measure and display functional saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Note that carboxyhemoglobin and methemoglobin are not capable of transporting oxygen, but is recognized as oxygenated hemoglobin by conventional pulse oximetry. This figure is for conceptual purposes only. MEASURED VS.
system description 2 Introduction The Radical-7 provides the functionality of three instruments in one: ■ The Radical-7 is a fully featured Handheld Pulse CO-Oximeter. ■ The Radical-7 is a fully featured Standalone Pulse CO-Oximeter. ■ The Radical-7 interfaces to the SpO2 input module of multiparameter patient monitors* to upgrade conventional pulse oximetry technology to Masimo SET technology.
2 system description Radical-7 Pulse CO-Oximeter Handheld system description HANDHELD RELEASE BUTTON 1 The Handheld Radical-7 Pulse CO-Oximeter provides most of the functionality of the Pulse CO-Oximeter. All user input and displays are controlled by this part of the Radical-7 Pulse CO-Oximeter system. The sensor cable connects into the connector on the Handheld unit. The Handheld is battery powered and can be used either as a transport monitor or as a Handheld Pulse CO-Oximeter for spot checks.
2 system description PULSE WAVEFORM DISPLAY 9 10 BATTERY STATUS INDICATORS 11 TOUCH KEY CONTROL BUTTONS 12 SPEAKER 13 PATIENT CABLE CONNECTOR TOUCH KEY ICONS 14 SIGNAL IQ 15 TIME AND DATE INDICATOR 16 Philips Vuelink OUTPUT MODE INDICATOR HP01 17 18 2-4 RadNet SERIAL OUTPUT MODE BACKLIGHT/ CONTRAST BUTTON The Pulse Waveform Display shows the acquired plethysmograph waveform. The pleth waveform is scaled with signal strength.
HANDHELD BACK PANEL The Handheld back panel features the interconnection to the Docking Station, an accessory mount for the pole clamp accessory and access to the Handheld battery pack. 1251 0000 536 11328/2269M-0805 MAIN SCREEN TREND GRAPH DISPLAY The Radical-7 Pulse CO-Oximeter provides a Trend Graph display function which allows the user to quickly check the trend of each parameter by allowing to step through and selecting the desired parameter.
2 system description Radical-7 Pulse CO-Oximeter Standalone When the Radical-7 Pulse CO-Oximeter Handheld is placed into the Docking Station, the Radical-7 Pulse CO-Oximeter becomes a full-featured standalone device. The Radical-7 Pulse CO-Oximeter Standalone acts as a battery charger for the Handheld device and has AC power connection capabilities. If the mains supply is temporarily interrupted, then the battery in the Handheld device will allow continuous operation.
2 system description STANDALONE BACK PANEL 1 2 SYMBOLS The following symbols are found on the Radical-7 Pulse CO-Oximeter Docking Station or packaging and are defined below: 3 2 system description NOTE: Some of the interfaces and symbols are not available in all versions of the Docking Station. P1 P2 P3 SYMBOLS MEDICAL ELECTRICAL EQUIPMENT UL 60601-1/CAN/CSA C22.2 No. 601.
2 system description Radical-7 Monitor Interface setup 3 Introduction Before the Radical-7 Pulse CO-Oximeter can be used in a clinical setting, it needs to be inspected, properly setup and the batteries need to be fully charged. Unpacking and inspection 120 97 76 Signal Extraction Sensor Off --- 95 %SpO2 1.65 3.00 3.0 0.
3 setup INITIAL BATTERY CHARGING Monitor Setup Before use, the Radical-7 Pulse CO-Oximeter Handheld battery and the optional Docking Station battery needs to be fully charged. The Radical-7 Pulse CO-Oximeter maintains three types of default values which will automatically revert to after a power cycle: ■ Factory – these options are restored to factory set values ■ Custom – these settings can be changed by the user and retained through the power cycle.
3 setup OPTION FACTORY DEFAULT SETTING PULSE BEEP VOLUME Set to Level 4 TREND DISPLAY PARAMETERS Set to %SpO2 + BPM TREND PERIOD Set to 1 Hr. LOW SpO2 ALARM LIMIT Set to 0 SpMet HIGH/LOW ALARM LIMIT SpCO HIGH/LOW ALARM LIMIT SMART TONE Set to High: 3.0/Low: --Set to High: 10/Low: --Set to No CONFIGURABLE SETTING Level 1 to 7 See Section 4, Display for all settings. See Section 4, Trend Setup for all settings.
3 setup 7. 8. 9. response). The Radical-7 Pulse CO-Oximeter’s ideal waveform necessitates the need for additional averaging by the monitor. If the multiparameter monitor’s averaging time is not changed, the time to display physiological changes in saturation on the monitor will be increased with SatShare. However, the delay can be minimized by reducing the multiparameter monitor’s averaging time.
3 setup operation RadNet Setup Introduction CAUTIONS: To operate the Radical-7 Pulse CO-Oximeter effectively, the device must be set up properly and the operator must: AFTER CONNECTING THE SERIAL CABLE TO THE SERIAL PORT, SATSHARE MONITORING WILL NOT BE SUPPORTED. SpMet AND SpCO CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH RADNET. NOTE: Confirm that the Radical Docking Station is RadNet Ready before preceeding. This is done by pressing the Menu button then selecting Output.
4 operation 10. Verify that the patient alarms are functional by setting the high and low SpO2, SpMet, SpCO and pulse rate alarm limits beyond the patient readings. An alarm tone sounds. The violated alarm limit and reading flash on the display. The red alarm indicator flashes on the Docking Station (standalone operation). 11. Verify the sensor alarms are functional by removing the sensor from the sensor site. SENSOR OFF appears in the message area of the graphic display.
4 operation cable. The pulsations from intra-aortic balloon support can cause the pulse rate displayed on the Pulse CO-Oximeter to be significantly different than the ECG heart rate. NUMERIC DISPLAY - SpCO A stable SpCO reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient’s fingertip (measurement site).
4 operation ■ If artificial nails or excessive fingernail polish are present, select another site or remove the polish/artificial nails. ■ If possible, ensure that the sensor is placed in a location with low ambient light. Although the Radical-7 with integrated Masimo Rainbow SET technology has significant immunity to ambient light, excessive ambient light may cause readings to be incorrect.
4 operation Simplified User Interface Navigating the Main Menu By enabling the Simplified User Interface, users are exposed to only the most common oximeter features, while the all the remaining settings remain available behind password protection. When the main menu is accessed, the plethysmograph and Signal IQ waveform displays are replaced with the main menu items. The touch key icons, displayed along the right edge of the LCD display, are also replaced by the menu access icons.
4 operation operation Time (hour/minute/seconds) MENU TREE Time display format SpO2 High/Low limit Pulse Rate High/Low limit (bpm) ALARMS 4 Day CLOCK Month SpMet High/Low limit Year SpCO High/Low limit Format (mm/dd/yy) Silence Display Clock Volume Delay (volume delay) ABOUT Software Version Mode Landscape 1 ROTATE SCREEN CONFIG Vertical 1 Enter password to change line frequency.
4 operation Alarms Alarms continued Check alarm limits each time the Pulse CO-Oximeter is used to ensure that they are appropriate for the patient being monitored. An audible alarm and a flashing alarm icon (and indicator light) will occur when an alarm limit is exceeded. It is best that the operator be within a minimum of 10 feet from the unit. MENU ITEMS SpO2 HIGH LIMIT MENU ITEMS 30, 60, 90,120 SECONDS DESCRIPTION The alarm silence can be set for these durations.
4 operation Alarms continued MENU ITEMS VOLUME 4 operation Rotate Screen DESCRIPTION MENU ITEMS This menu allows the user to set the alarm volume. Four levels are available: level 1 being the softest and level 4 being the loudest. The device retains the Alarm Volume setting upon a power cycle. DESCRIPTION LANDSCAPE 1 The viewing screen will be in a horizontal fashion when the Radical-7 is in the upright, horizontal position.
4 operation Display continued Display MENU ITEMS VIEW TREND 4-16 4 operation DESCRIPTION Five views are available: PVI Pleth and Signal IQ, PVI Pleth, Pleth and Signal IQ, Numbers and Pleth Only. PVI PLETH + SIGNAL IQ / PLETH + SIGNAL IQ Shows the SpO2 and pulse rate numbers on the left or top of the screen. The PVI plethysmograph-Signal IQ and plethysmograph-Signal IQ waveforms are on the right, two-thirds or bottom of the screen.
4 operation General MENU ITEMS 4 operation Clock DESCRIPTION MENU ITEMS DESCRIPTION The signal averaging time of this device can be set to: 2, 4, 8, 10, 12, 14 and 16 seconds*. TIME Set the time - hour, minutes and seconds - in 24 hour format. *With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings, the averaging times may range from 2 to 4 and 4 to 6 seconds, respectively.
4 operation Output 4 operation Output continued NOTE: The output menu selections are only available when the Radical-7 Handheld is interfaced to the Docking Station. MENU ITEMS DESCRIPTION 0V OUTPUT MENU ITEMS DESCRIPTION The following serial output modes are supported. All serial output is RS232 based. See the interface specifications in Section 7, Specifications. ASCII 1 ANALOG1 OR ANALOG 2 (CONTINUED) ALARMS The nurse call output will be activated based on alarm events.
4 operation 4 operation Service Trend Display NOTE: The Service menu selections are only available when the Radical-7 Pulse COOximeter Handheld is interfaced to the Docking Station. Once the Trend Display touch key icon is selected, the trend data is displayed on the main screen. The Radical-7 Pulse CO-Oximeter stores one data set of SpO2, pulse rate, SpMet, SpCO, PI, PVI and system messages in a dedicated memory area.
4 operation 4 operation NAVIGATING THE TREND DISPLAY In the Trend Display view there are a total of 10 touch key icon selections on 3 pages of menu selections. These menu screens are not accessible when using the Simplified User Interface. FIRST PAGE Masimo SET 1 Hr 98 71 100 100 %SpO2 Trend 4/11/06 14:28:20 96 98 96 PI 15:28:20 2.6 11.9 8.8 85 %SpO2 50 20 140 50 BPM 0 NEXT MENU PAGE Press the Next Menu Page button to access the next page of menu selections.
4 operation TREND SETUP 4 operation MENU ITEMS DESCRIPTION SERIAL DUMP To send all the data that is stored in trend memory to the serial port, select the Serial Dump option. Use this option to communicate the stored data set to trend graphing software applications.
4 operation operation ■ Once the Radical-7 Pulse CO-Oximeter detects that the SatShare cable is disconnected from the patient monitor, or if the patient monitor is turned off, the Radical-7 automatically returns to normal, standalone operation. ■ In the SatShare mode, the pulse beep tone of the Radical-7 Pulse CO-Oximeter is initially set to the lowest volume (mute). The pulse beep volume can be manually increased. Refer to Section 4 Traditional User Interface.
4 operation alarms and messages To return from SatShare operation to normal standalone operation, simply disconnect the SatShare cable from the patient monitor or disconnect the SatShare cable from the SatShare connector on the back of the Radical-7 Pulse CO-Oximeter. System Messages Home Mode Operation The operator should become thoroughly familiar with this information before using the oximeter for patient monitoring.
5 alarms and messages MESSAGE NO SENSOR POSSIBLE CAUSE(S) • Sensor not fully inserted into the connector. RECOMMENDATION • Maybe an incorrect sensor, or a defective sensor or cable. • Insert sensor into connector. • Disconnect and reconnect sensor. • Refer to the instructions for the sensor being used. • Unit is searching for patient’s pulse. • Disconnect and reconnect the sensor into the Patient Cable Connector. PULSE SEARCH • Unit is searching for patient’s pulse.
5 alarms and messages alarms and messages Desat Index Alarm USER INTERACTION TO IMPLEMENT DESAT INDEX ALARM Traditional high and low SpO2 alarm limits alert clinicians to saturation levels that exceed user-selected thresholds and these thresholds are typically established at a considerable change from the patients’ baseline saturation level.
5 alarms and messages Perfusion Index (PI) Delta Alarm Perfusion Index gives an indication of the level of perfusion at the monitored site. The Radical-7 measures perfusion at the SpO2 site by comparing the pulsatile signal to the nonpulsatile signal, and expressing that ratio as a percentage.
6 troubleshooting Troubleshooting The following chart describes what to do if the Radical-7 Pulse CO-Oximeter system does not operate properly or fails. PROBLEM POSSIBLE CAUSE(S) UNIT DOES NOT POWER One or both of the fuses ON. have blown. UNIT POWERS ON BUT THE GRAPHIC DISPLAY IS BLANK. The viewing contrast is not correct. CONTINUOUS SPEAKER Internal failure. TONE. BUTTONS DON’T WORK WHEN PRESSED Internal failure. RECOMMENDATION Replace the fuses.
6 troubleshooting PROBLEM LOW SIGNAL QUALITY POSSIBLE CAUSE(S) Improper sensor type or application. Excessive motion relative to perfusion. Sensor is damaged or not functioning. RECOMMENDATION 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. Check for error messages. See section 5 System Messages for recommended corrections. SpO2 VALUES DO NOT Check placement of sensor or if it is too tight.
7 specifications Radical-7 specifications PERFORMANCE Measurement Range Oxygen Saturation (%SpO2): 0 -100% Carboxyhemoglobin Saturation (%SpCO): 0 - 99% 0 - 99.9% Methemoglobin Saturation (%SpMet): Pleth Variability Index Pulse Rate: Perfusion Index: 0 - 99% 25 - 240 beats per minute (bpm) 0.
7 specifications Docking Station (RDS-1B, RDS-3B): Type: Capacity: Charging time: Display/Indicators NiMH 10 hours6 6 hours ENVIRONMENTAL Transport/Storage Temperature: 41°F to 104°F (5°C to 40°C) -40°F to 158°F (-40°C to +70°C)7 Operating Humidity: 5% to 95%, non-condensing Operating Altitude: 500 mbar to 1060 mbar pressure -1000 ft to 18,000 ft (-304 m to 5,486 m) PHYSICAL CHARACTERISTICS Dimensions: Handheld: Standalone: %SpO2, %SpCO, %SpMet, pulse rate, pleth waveform, alarm status, trends, s
7 specifications Serial interface specifications The digital interface for serial communication is based on the standard RS-232 protocol. The Radical-7 Pulse CO-Oximeter by default always outputs ASCII 1 text data through the serial port, unless the user selects a different output mode in the Output menu.
7 specifications 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-7 Pulse CO-Oximeter analog output / nurse call interface is only available when the Radical-7 Pulse CO-Oximeter Handheld is properly attached to the Radical-7 Pulse CO-Oximeter Docking Station. Only use an analog / nurse call cable that has a ferrite bead installed.
sensors & patient cables 8 Introduction This section covers the use and cleaning of Masimo sensors and patient cables. Before use of any sensor, carefully read the sensor’s Directions for Use. Use only Masimo oximetry sensors and cables for SpO2, SpMet and SpCO measurements. Other oxygen transducers or sensors may cause improper Radical-7 Pulse COOximeter performance. Tissue damage can be caused by incorrect application or use of a sensor, for example by wrapping the sensor too tightly.
8 sensors & patient cables Masimo Rainbow Sensors Masimo SpO2 Sensors Masimo Rainbow sensors must be used with the Radical-7 Pulse CO-Oximeter to enable measurement of Carboxyhemoglobin (SpCO) and Methemoglobin (SpMet). Rainbow sensors will only function with instruments containing Masimo Rainbow SET Technology or licensed to use Rainbow compatible sensors.
8 sensors & patient cables ® TM LNOP ADHESIVE SENSORS (LNOP sensors must be used in conjunction with Red PC cables) SENSOR Weight Range Saturation Accuracy No Motion Motion ± 2% ± 3% Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm 8 sensors & patient cables LNCS REUSABLE SENSORS (LNCS sensors must be used in conjunction with Red LNC or Rainbow patient cables) Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm SENSOR Weight Range Saturation Accuracy No Motion Motion ± 2% ± 3% Pulse
8 sensors & patient cables SENSOR ACCURACY Refer to Section 7, Specifications for SpO2, SpMet, SpCO and pulse rate accuracy. Unless otherwise specified in the previous tables: The sensor accuracy specified is when used with Masimo Rainbow SET technology Pulse CO-Oximetry monitors or with licensed Masimo SET pulse oximetry modules during no motion. Accuracy range variation equals ± 1 standard deviation. Plus or minus one standard deviation represents 68% of the population.
9 service / maintenance Battery Operation and Maintenance The Radical-7 Pulse CO-Oximeter Handheld includes a 1.5 Amp-Hour Nickel Metal Hydride battery. The Radical-7 Pulse CO-Oximeter Docking Station may include the optional 6.5 Amp-Hour Nickel Metal Hydride battery. Before using the Radical-7 Pulse CO-Oximeter as a Handheld or transport monitor, the Handheld battery and the optional Docking Station battery need to be fully charged.
9 service / maintenance service / maintenance REPLACING THE BATTERIES ■ Before installing or removing the battery, make sure the AC power cord is removed and power to the Pulse CO-Oximeter is turned off. 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. To replace the Handheld battery, follow these instructions: To replace the fuse(s), you will need a flat-blade screwdriver (5mm; 3/16”). 1.
9 service / maintenance Power-On Self-Test: Testing with Masimo SET Tester (Optional): 1. Connect the monitor to AC power and verify that the AC Power Indicator is lit. 1. Turn the Radical-7 off and then on again. 2. Turn the monitor on by depressing the Power/Standby Button. Within 5 seconds all available LEDs are illuminated, a 1-second beep tone sounds, and the Masimo SET logo is displayed. 2. Set the alarm limits to: 3.
9 service / maintenance service / maintenance Analog Output Test Service and repair 1. Disconnect all patient cables and sensors from the Radical-7. Turn the Radical-7 off and then on again. 2. Connect the common lead of a digital voltmeter to the pin 2 (Ground) of the analog output connector on the Radical-7. Connect the positive lead of the voltmeter to pin 9 (Analog 1) of the analog output connector.
9 service / maintenance Warranty Masimo warrants to the initial purchaser that each new Pulse CO-Oximeter will be free from defects in workmanship or materials for a period of one (1) year from the date of purchase. Masimo’s sole obligation under this warranty is to repair or replace any product that Masimo deems to be covered under warranty with a repaired or a replacement Pulse CO-Oximeter. service / maintenance 2.
Section 10 Accessories 10 accessories Accessories The following accessories and re-order parts are available with the Radical-7 Signal Extraction Pulse CO-Oximeter: DESCRIPTION 1315 REPLACEMENT BATTERY, RADICAL-7 HANDHELD 1317 RADICAL-7 POLE CLAMP 1395 RADICAL-7 HANDHELD LOCK 1584 RADICAL-7 POWER CORD LOCK, 5/PACK 1595 SATSHARE CABLE, AT01 1324 SATSHARE CABLE, DO01 1326 SATSHARE CABLE, DO02 1528 SATSHARE CABLE, DO03 1533 SATSHARE CABLE, DO04 2023 SATSHARE CABLE, DO05 1325 SATSHARE C
www.masimo.com Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo. © 2007 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, FastSat, Satshare, SET, LNOP and LNCS are federally registered trademarks of Masimo Corporation. Radical-7, RadNet, RadicalScreen and LNOPv and are trademarks of Masimo Corporation.
