with color display signal extraction pulse co-oximeter with Rainbow Technology OPERATOR’S MANUAL
with color display 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.
table of contents 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 and Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 overview Warnings, Cautions and Notes Product Description Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: The Radical-7 Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. The Radical-7 Pulse CO-Oximeter can be used as either a Handheld or a Standalone monitor.
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 FUNCTIONAL VS. FRACTIONAL SATURATION The Radical-7 is calibrated to measure and display functional saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The Radical-7 does not measure fractional saturation: oxygenated hemoglobin expressed as a percentage of the four main hemoglobin species, i.e., oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin.
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. Masimo rainbow The Handheld portion of the Radical-7 contains the majority of the Pulse CO-Oximeter features.
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 The SpCO Alarm Limits Display shows the upper and lower alarm limits. When the measured value is outside of the alarm limits, the SpCO measurement display flashes and an alarm will sound The Pulse Waveform Display shows the acquired plethysmoPULSE graph waveform. The pleth waveform is scaled with signal WAVEFORM strength. Signal strength is defined as the relation of arterial DISPLAY pulsatile signal to the non-pulsatile signal component.
2 Masimo rainbow SET 99 85 Sp0 2 140 50 BPM 1 Hr 50 5 3.0 0.3 SpMet 1251 0000 536 1 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.
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 back of 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 setup Radical-7 Monitor Interface Introduction In addition to being a full-featured Handheld and Standalone Pulse CO-Oximeter, the Radical-7 Pulse CO-Oximeter’s unique SatShare interface links the Radical-7 Pulse COOximeter to most existing multiparameter patient monitors through the pulse oximetry patient cable or SpO2 input connector.
3 setup INITIAL BATTERY CHARGING Before use, the Radical-7 Pulse CO-Oximeter Handheld battery and the optional Docking Station battery needs to be fully charged. Monitor Setup To charge the batteries: ■ Factory – these options are restored to factory values 1. Attach the Handheld unit to the Docking Station. ■ 2. Plug in the AC power cord to power entry module. Make sure it is securely plugged in. Custom – these settings can be changed by the user and retained through the power cycle. ■ 3.
3 setup OPTION DEFAULT SETTING SATSHARE SETUP TREND PERIOD Set to 1 Hr. 1. LOW SpO2 ALARM LIMIT Set to 0 SpMet HIGH/LOW ALARM LIMIT Set to High: 3.0/Low: --- SpCO HIGH/LOW ALARM LIMIT Set to High: 45/Low: --- SMART TONE Set to Yes ADULT/NEO (HOSPITAL DEFINED) SETTINGS The following table outlines settings that may be defined by the hospital. If enabled (via a password protected screen, see Section 4 Password Operation), these settings will return to pre defined values after a power cycle.
3 setup 9. setup Set the SatShare Numbers and the Interface Alarms parameters in the General menu according to Customer preference. 1. Select the Philips VueLink selection from the Output menu on the Radical-7 Pulse CO-Oximeter. Refer to Section 4, Output. 10. If displaying the simulated waveform is not desirable, it is recommended to turn off the pleth waveform display of the multiparameter patient monitor. 2.
3 setup operation NOTE: Confirm that the Radical Docking Station is RadNet Ready before proceeding. Introduction 1. Select the ASCII 2 selection from the Output menu on the Radical-7 Pulse CO-Oximeter. To operate the Radical-7 Pulse CO-Oximeter effectively, the device must be set up properly and the operator must: 2. Connect one end of the serial cable to the Serial Output connector on the back of the Docking Station.
4 operation operation 4 Successful Monitoring 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.
4 operation 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). Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. Inaccurate measurements may be caused by: ■ Significant levels of methemoglobin.
4 operation electrical/electronic equipment. If these solutions are not possible, operate the Pulse CO-Oximeter on battery power, or try plugging the Pulse CO-Oximeter into a different electrical outlet. ■ ■ 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.
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 EDITING A PARAMETER Once a parameter has been selected for editing, a new set of menu selections and icons are displayed. EXIT Select the Exit icon to exit the parameter without making the new selections permanent. ACCEPT Select the Accept icon to save the changes PREVIOUS Select the Previous icon to increase or toggle the parameter settings. NEXT Select the Next icon to decrease or toggle the parameter settings.
4 operation Alarms MENU ITEMS 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.
4 operation MENU ITEMS VOLUME DELAY 4 operation Rotate Screen DESCRIPTION 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. MENU ITEMS DESCRIPTION NOTE: For home use, set the alarm level to level 4. 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 operation DESCRIPTION Three views are available: Pleth and Signal IQ, Numbers and Pleth Only. PLETH + SIGNAL IQ Shows the SpO2 and pulse rate numbers on the left or top of the screen. The plethysmograph and Signal IQ waveform on the right, two-thirds or bottom of the screen. The screen also indicates the signal strength of the measured signal as a perfusion index (PI).
4 operation General About MENU ITEMS DESCRIPTION The signal averaging time of this device can be set to: 2, 4, 8, 10, 12, 14 and 16 seconds*. AVERAGING TIME *With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings, the averaging times may range from 2-4 and 4-6 seconds, respectively. Select Yes to activate the FastSat algorithm. In the 2 and 4 seconds averaging mode, the FastSat algorithm is automatically enabled. FASTSAT Set the Radical-7 to the Home Mode.
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 RS-232 based. See the interface specifications in Section 7-Specifications. ANALOG1 OR ANALOG 2 (CONTINUED) ASCII text data is sent to the serial interface at one-second intervals.
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 and system messages in a dedicated memory area.
4 operation Masimo rainbow SET 1 Hr 99 85 Sp0 2 100 140 50 BPM 50 PI FIRST PAGE 10/11/06 11:23:11pm 12:23:11pm Trend SpMet 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 accessable when using the Simplified User Interface. 2 1 98 1.7 4 operation 96 97 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 Masimo rainbow SET 1 Hr SpO2 SpMet SpCO 100 15.0 40 Min 50 1.0 1.0 140 50 BPM BPM PI Max 200 20 Min 25 1 Default View 1 min Trend Action None Trend Period 2 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 BacklightOperation ■ The backlit LCD screen of the Radical-7 Pulse CO-Oximeter Handheld can be set to four levels of illumination, in addition to no illumination, when the Radical-7 Pulse CO-Oximeter operates as a standalone Pulse CO-Oximeter. The Radical-7 Pulse CO-Oximeter temporarily indicates the illumination level on the display following a change in illumination level.
4 operation alarms and messages ■ ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED. System Messages ■ SPMET, SPCO AND PI CANNOT BE DISPLAYED ON THE MULTIPARAMETER MONITOR WITH SATSHARE. The following chart alphabetically lists all system messages displayed on the LCD screen. The cause of the message, and the action(s) to be taken are also shown.
5 alarms and messages MESSAGE POSSIBLE CAUSE(S) RECOMMENDATION alarms and messages 3D Alarm System Option Contact Masimo Tech Support. Refer to Section 9 Service and repair. This section applies only if you have purchased the optional 3D Alarm System. Contact Masimo if you are interested in purchasing this option. Cable not attached or not fully inserted into the connector. Disconnect and reconnect cable into connector. Purpose Sensor not fully inserted into the connector.
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) Low battery/ not plugged into AC power supply DIFFICULTY OR NO SpCO/SpMet READING Inappropriate sensor RECOMMENDATION Interference from line-frequency induced noise. Verify/set 50/60hz menu setting. Refer to Section 3, Initial Setup for details. Verify use of an SpCO/SpMet capable sensor.
7 specifications Radical-7 specifications PERFORMANCE Measurement Range Oxygen Saturation (%SpO2): Carboxyhemoglobin Saturation (%SpCO): 0-100% Methemoglobin Saturation (%SpMet): 0-99.9% Pulse Rate: Perfusion Index: Response Time: 0-99% 25-240 beats per minute (bpm) 0.
7 specifications Docking Station (RDS-1B): Type: Capacity: Charging time: Display/Indicators NiMH 10 hours6 6 hours ENVIRONMENTAL Operating Temperature: Storage Temperature: Operating Humidity: Operating Altitude: 41°F to 104°F (5°C to 40°C) -40°F to 158°F (-40°C to +70°C)7 5% to 95%, non-condensing 500 mbar to 1060 mbar pressure -1000 ft to 18,000 ft (-304 m to 5,486 m) Data display: %SpO2, %SpCO, %SpMet, pulse rate, pleth waveform, alarm status, trends, status messages, Signal IQ, perfusion index,
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-Oximeterocking 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, SpCO and SpMet measurements. Other oxygen transducers or sensors may cause improper Radical-7 Pulse CO-Oximeter 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 PC cables) SENSOR Weight Range Saturation Accuracy No Motion Motion ± 2% ± 3% 8 sensors & patient cables LNCS ADHESIVE SENSORS (LNCS sensors must be used in conjunction with LNC or Rainbow cables) Pulse Rate Accuracy No Motion Motion ± 3 bpm ± 5 bpm Low Perfusion Accuracy Saturation Pulse Rate ± 2% ± 3 bpm SENSOR Weight Range Saturation Accuracy No Motion Motion ± 2% ± 3% Pulse Rate Accuracy N
8 sensors & patient cables SENSOR ACCURACY Refer to Section 7, Specifications for SpO2, SpMet, SpCO and pulse rate accuracy, unless otherwise specified in the tables above. Accuracy specified when used with Masimo Rainbow SET technology Pulse CO-Oximetry monitors or with licensed Masimo SET pulse oximetry modules during no motion. Numbers represent ± 1 standard deviation. Plus or minus one standard deviation represents 68% of the population. SpO2 accuracy from 70% to 100%.
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 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 installing or removing the battery, make sure the AC power cord is removed and power to the Pulse CO-Oximeter is turned off. 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.
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 CABLE, DS01 1539 SATSHA
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, Radical logo, Signal IQ, LNOP and LNCS are federally registered trademarks of Masimo Corporation. Rainbow and SpCO are federally registered trademarks of Masimo Laboratories. Radical-7, RadNet, RadicalScreen, LNOPv and APOD are trademarks of Masimo Corporation.
