Signal Extraction Pulse Oximeter OPERATOR’S MANUAL
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. Do not operate the Radical Pulse Oximeter without completely reading and understanding these instructions.
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.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a short time. ■ This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1994, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
table of contents SECTION 1 / OVERVIEW About this Manual ........................................................................................................................1 Warnings, Cautions and Notes ....................................................................................................2 Product Description ......................................................................................................................3 Features and Benefits......................................
table of contents SECTION 4 / OPERATION Introduction ................................................................................................................................21 Basic Operation ..........................................................................................................................21 General Setup and Use ..........................................................................................21 Successful SpO2 Monitoring ..........................................
table of contents Home Use................................................................................................................33 Interface Alarms ......................................................................................................33 SatShare Numbers ..................................................................................................33 Power Save..............................................................................................................
table of contents Backlight / Contrast Operation....................................................................................................40 SatShare Operation ....................................................................................................................40 Home Mode Operation ..............................................................................................................42 Password Operation.....................................................................
table of contents SECTION 9 / SERVICE AND MAINTENANCE Introduction ................................................................................................................................57 Cleaning ................................................................................................................................57 Battery Operation and Maintenance ..........................................................................................58 Replacing the Batteries ....................
ix Radical Signal Extraction Pulse Oximeter Operator’s Manual
1 overview 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. Read the entire safety information section before you operate the monitor.
overview 1 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.
overview product 1 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 for SpO2, pulse rate, plethysmographic waveform and Signal Identification and Quality TM Indicator (Signal IQ ).
overview 1 pulse oximetry GENERAL DESCRIPTION Pulse 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 oximetry instrument with a patient cable.The sensor collects signal data from the patient and sends it to the instrument.
overview 1 FUNCTIONAL VS. FRACTIONAL SATURATION The Radical measures and displays functional saturation: the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. The Radical does not measure fractional saturation: oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin.
system 2 description introduction Radical provides the functionality of three pulse oximeters in one: ■ Radical is a fully featured Handheld pulse oximeter ■ Radical is a fully featured standalone pulse oximeter ■ Radical interfaces to the SpO2 input module of multiparameter patient monitors* to upgrade conventional pulse oximetry technology to Masimo SET technology. 90 4 The Handheld portion of Radical contains the majority of the pulse oximeter features.
system radical description 2 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.
system 2 1 Handheld Release Button Press down the Handheld Release Button and pull the Handheld device off the Docking Station. 2 SpO2 Measurement Display The functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO2. The upper and lower SpO2 alarm limits are also displayed next to the SpO2 measurement. When a sensor is not connected to a patient and during pulse search, the display will show dashed lines.
system description 2 The Pulse Waveform Display shows the acquired plethysmograph waveform. The pleth waveform is scaled with signal strength. Signal strength is defined as the relation of arterial pulsatile signal to the non-pulsatile signal component. The Pulse Waveform Display is updated with a frequency of 31.25 times per second. 15 Pulse Waveform Display 16 Time and Date The Time and Date Indicator displays the current time and date.
system 2 description 1 10 2 1251 0000 536 11328J-1000 MEDICAL ELECTRICAL EQUIPMENT UL 2601-1/CAN/CSA C22.2 No. 601.1 80FK 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. 3 1 Docking Station Connector The Radical Handheld interfaces with the Docking Station through this connector.
system radical 2 description 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. The Standalone can also interface to serial devices, nurse call or analog output devices, and multiparameter patient monitors through a SatShare cable. There are several models of Docking Stations available.
system 2 description STANDALONE FRONT PANEL The following figure and corresponding text review the features of the Radical Standalone device. 1 Masimo SET FastSat Check Sensor 2 100 85 %SpO2 3 140 50 BPM 4 11:42:46 03/27/01 5 1 Docking Station Battery Charging Indicator The Docking Station Battery Charging Indicator is illuminated when the Docking Station battery is charging. The indicator blinks just prior to charging.
system description 2 STANDALONE BACK PANEL 1 3 2 P2 P3 MEDICAL ELECTRICAL EQUIPMENT UL 2601-1/CAN/CSA C22.2 No. 601.1 80FK Made in USA U.S.A. Patents 5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,738,644; 5,769,785. Rx Only 5 4 Serial Output Connector Use the Serial Output Connector to connect a serial device, including a serial printer or PC, to the Radical. The data is provided in standard RS-232C format. See Section 7, Serial Interface Specifications.
2 system description 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 See Instructions for Use Fuse Replacement Analog Out Interface Nurse Call Interface NOTE: Some of the interfaces and symbols are not available in all versions of the Docking Station.
3 set-up introduction 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. unpacking and inspection Remove the instrument from the shipping carton and examine 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.
3 set-up ■ IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH CONDUCTOR ARRANGEMENT, OPERATE THE OXIMETER ON INTERNAL BATTERY POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS FULLY FUNCTIONAL. ■ TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS. ■ DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH OR DIMMER.
3 set-up monitor setup The Radical Pulse Oximeter stores two types of default values: those that Radical automatically reverts to after a power cycle, and those that can be changed by the user and will be remembered after a power cycle. The following table outlines the default values that Radical reverts to after a power cycle.
3 set-up ALARM VOLUME Set to pre-power down setting PULSE BEEP VOLUME Set to pre-power down setting TREND DISPLAY PARAMETERS Set to pre-power down setting TREND PERIOD Set to pre-power down setting 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.
set-up 4. Verify that Radical recognizes the correct cable. The name of the SatShare cable will be displayed on the LCD screen when the SatShare mode is functional. 5. Set the multiparameter monitor’s high and low saturation and pulse rate alarm limits as appropriate. 6. Set the multiparameter monitor's averaging time to the lowest setting (i.e. fastest response). Radical's ideal waveform obviates the need for additional averaging by the monitor.
set-up 3 hp vuelink 1. Select the HP VueLink selection from the Output menu on the Radical. Refer to Section 4, Output. 2. Connect one end of the VueLink cable to the Serial Output connector on the back of the Docking Station. 3. Connect the other end of the VueLink cable to the VueLink module and insert the module into the HP/Agilent monitor rack. 4. The SpO2 and pulse rate values will automatically appear on the HP/Agilent monitor. 5.
operation 4 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). ■ Be familiar with its controls, components and operation. ■ Understand its status and alarm messages (see Section 5, Alarm Identification, System Messages and Section 6, Troubleshooting). basic operation GENERAL SETUP AND USE 1. Inspect the oximeter case for damage. 2.
4 operation 11. Verify that the patient alarms are functional by setting the high and low SpO2 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). 12. 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. ■ The alarm tone sounds.
operation successful 4 SpO 2 monitoring The following general points will aid in ensuring oximetry monitoring success. ■ Place the sensor on a site that has sufficient perfusion and provides proper alignment of the LED’s and photodetector. ■ Place the sensor on a site that has unrestricted blood flow. ■ Do not constrict the monitoring site when securing a sensor with tape. ■ Do not select a site near potential electrical interference (electrosurgical unit, for example).
operation 4 SIGNAL IQ The Radical 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 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. With motion, the plethysmographic waveform is often distorted and may be obscured by artifact.
operation 4 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 saturation1. This “localized hypoxemia” may result from the metabolic demands of other tissues extracting oxygen proximal to the monitoring site under conditions of sustained peripheral hypoperfusion.
4 operation touch key control buttons and icons touch key control button The touch key control buttons are the four dark grey control buttons to the right of the 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 Page Press the Next Menu Page button to access the second page of selections.
4 operation navigating the main menu 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. When the main menu is accessed the monitor remains functional and the saturation and pulse rate numbers will continue to be displayed.
4 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.
operation 4 Time (hour/minute) Time display format CLOCK Date (day/month/year) Date display format ABOUT Software Version Serial Mode OUTPUT SERVICE Analog Output Mode Handheld Battery Deep Discharge DS Battery Deep Discharge Radical Signal Extraction Pulse Oximeter Operator’s Manual 29
4 operation alarms Check alarm limits each time the pulse 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 met or exceeded. MENU ITEMS DESCRIPTION SpO2 HIGH LIMIT The SpO2 high alarm limit can be set anywhere between 2% and 100%, with a 1% step size. In the “----” (off) setting, the alarm can be turned off completely.
operation SILENCE 4 This menu allows the user to set the alarm silence period. An alarm is silenced by pressing the Alarm Silence button on the front panel. 30, 60, 90,120 SECONDS The alarm silence duration is set. As an indicator that the alarm system is silenced, the Alarm Status Indicator is shown as a bell with a slash through it. A timer is shown next to the bell indicating the remaining alarm silence duration.
4 operation display MENU ITEMS VIEW 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, and the plethysmograph and Signal IQ waveform on the right or bottom of the screen. The Screen also indicates the signal strength of the measured signal as a perfusion index (PI). The PI is calculated as the relation of arterial pulsatile signal to the non-pulsatile signal component.
operation 4 general MENU ITEMS DESCRIPTION AVERAGING TIME The signal averaging time of this device can be set to: 2, 4, 8, 10, 12, 14 and 16 seconds*. *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. FASTSAT Select “Yes” to activate the FastSat algorithm. In the 2 and 4 seconds averaging mode, the FastSat algorithm is automatically enabled.
4 operation about This displays the copyright and software versions of the Handheld and Docking Station. output Note: The output menu selections are only available when the Radical Handheld is interfaced to the Docking Station. MENU ITEMS SERIAL MODE DESCRIPTION The following serial output modes are supported. All serial output is RS-232 based. See the interface specifications in Section 7, Specifications. ASCII 1 ASCII text data is sent to the serial interface at one-second intervals.
operation 4 1V Output A 1 Volt calibration signal is mapped onto the SpO2 and pulse rate analog output. Use this signal for calibration of recording devices. (1 Volt represents a saturation of 100% and a pulse rate of 250 bpm). CAUTION: TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE SERIAL PORT ON THE BACK PANEL UNLESS THE RADICAL PULSE OXIMETER IS CONNECTED TO THE AC MAIN POWER SUPPLY.
4 operation trend display Once the Trend Display touch key icon is selected the trend data is displayed on the main screen. The Radical stores one data set of SpO2, pulse rate and system messages in a dedicated memory area. 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.
operation Masimo SET 10 Min 91 100 85 %SpO2 140 50 BPM 4 100 % SpO2 90 Trend 97 03/27/01 99 BPM 11:42:46 60 70 80 60 160 30 1 The top line on the trend display shows the time scale of the trend graph, followed by the starting date, starting time and end time of the data set that is displayed on the screen. 2 The second line of the display shows the minimum, average, and maximum SpO2 and pulse rate measurements contained in the displayed data set (excluding zero measurements).
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. FIRST PAGE Next Menu Page Press the Next Menu Page button to access the next page of menu selections. Exit Press the Exit button to return to the normal display screen. Scroll Left Press the Scroll Left button to scroll through the data set. The display scrolls by ½ the selected time scale.
operation 4 TREND SETUP This menu allows the user to set the default trend settings and to clear the trend data, or download the trend data to the serial port. The default settings are used to scale the trend graphs when the trend data button, located on the main display, is accessed. MENU ITEMS DESCRIPTION %SpO2 HIGH SCALE: Sets the high scale of the SpO2 trend graph. %SpO2 LOW SCALE: Sets the lower scale of the SpO2 trend graph.
4 operation TREND PERIOD The Trend period setting determines how often a set of SpO2 and pulse rate data points is stored in trend memory. A setting of 2, for example, sets the Radical to store one set of SpO2 and pulse rate measurements every 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.
operation ■ 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. ■ Once Radical detects the presence of a patient monitor, the SatShare cable type remains constantly displayed on the LCD screen. ■ Patient Alarms of the multiparameter patient monitor will be triggered by the alarm setting of the patient monitor and not the Radical.
4 operation home mode operation The Radical can be placed into the Home Mode to protect unqualified users from changing the Radical alarm settings and operation. Entering a password does not automatically reset the Radical to the Normal operating mode. In the Home Mode, a password is required to access the menu system and the touch key control buttons and icons.
alarms/messages 5 introduction The following sections outline system alarms, messages displayed on the LCD screen. Please become thoroughly familiar with this information before operating the pulse oximeter. alarm identification 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.
5 alarms/messages alarm operation 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. Saturation changes of greater than 5% are indicated immediately, irrespective of averaging time.
alarms/messages system 5 messages 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. The operator should become thoroughly familiar with this information before using the oximeter for patient monitoring. MESSAGE POSSIBLE CAUSE(S) RECOMMENDATION AMBIENT LIGHT Too much light on patient (sensor). Inadequate tissue covering sensor detector. Remove or reduce lighting. Cover sensor from light.
5 alarms/messages NO SENSOR Sensor not fully inserted into the connector. Sensor inserted upside down. May be 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. Disconnect and reconnect the sensor with the logos matching. PULSE SEARCH Unit is searching for patient’s pulse. If values are not displayed within 30 seconds, disconnect and reconnect sensor.
6 troubleshooting troubleshooting The following chart describes what to do if the Radical system does not operate properly or fails. PROBLEM POSSIBLE CAUSE(S) RECOMMENDATION UNIT DOES NOT POWER ON. One or both of the fuses have blown. Replace the fuses. UNIT POWERS ON BUT THE GRAPHIC DISPLAY IS BLANK. The viewing contrast is not correct. Use the Backlight/Contrast button to adjust the viewing angle. If the condition persists, the unit requires service. CONTINUOUS SPEAKER TONE. Internal failure.
7 specifications radical specifications PERFORMANCE measurement range SpO2: Pulse Rate: Perfusion: 1-100% 25-240 beats per minute (bpm) 0.
7 specifications 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)6 5% to 95%, non-condensing 1060 mbar to 500 mbar pressure, -1000 ft to 18,000 ft (-304 m to 5,486 m) PHYSICAL CHARACTERISTICS dimensions Handheld: Standalone: 8.9” x 3.3” x 2.1” (22.6 cm x 8.4cm x 5.3 cm) 3.5” x 10.5” x 7.7” (8.9 cm x 26.7cm x 19.
7 specifications compliance EMC Compliance: Equipment Classification: EN60601-1-2, Class B IEC 60601-1-1 / UL 2601-1 Type of Protection: Class 1 (on AC power), Internally powered (on battery power) Degree of Protection-Patient Cable: Type BF-Applied Part Degree of Protection-SatShare Cable: Type CF-Applied Part Enclosed Degree of Ingress Protection from Solids/Liquids: IPX1 Mode of Operation: Continuous 1 The Masimo SET Radical Pulse Oximeter with LNOP Adt sensors has been validated for no motion accurac
7 specifications 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 NUMBER OF BITS PER CHARACTER 8 PARITY None BITS 1 start, 1 stop HANDSHAKING None CONNECTOR TYPE Female DB-9 The pin-outs for the RS-232 connector are shown in the following table: PIN SIGNAL NAME 1 No Connection 2 Receive data – RS-232 ±9 V (±5 Vmin) 3 Transmit data – RS-232
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 analog output / nurse call interface is only available when the Radical Handheld is properly attached to the Radical Docking Station. NOTE: The analog output/nurse call interface is no available in all version of the Docking Station. WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE RS-232 SERIAL PORT MUST BE IEC-60950 COMPLIANT.
7 specifications ANALOG OUTPUT Radical can interface with various analog recording devices and/or strip chart recorders through its Analog Output connector located on the back of the Docking Station. SpO2 and pulse rate parameters are output simultaneously and continuously. The output signals vary from approximately 0 to 1 volt in a linear fashion. NOTE: The actual SpO2 and Pulse Rate voltages will vary from approximately 40mV to 980mV in 3.9mV steps. SpO2 0 volts represents either 0% SpO2 or 50% SpO2.
8 sensor/patient cables introduction This section covers the use and cleaning of Masimo LNOP sensors and Masimo SET patient cables. masimo LNOP ® sensors Before use, carefully read the LNOP sensor Directions for Use. Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen transducers or sensors may cause improper Radical Pulse Oximeter performance. Tissue damage can be caused by incorrect application or use of an LNOP sensor, for example by wrapping the sensor too tightly.
sensor/patient cables SENSOR USAGE PATIENT WEIGHT LNOP ADT Single Use Adults > 30 kg LNOP PDT Single Use Pediatrics and Slender Adults >10 kg and < 50 kg LNOP NEO Single Use Neonate < 10 kg LNOP NEO PT Single Use Neonate < 1 kg, or with poor skin integrity LNOP DCI Reusable Adults and Pediatrics > 30 kg LNOP DCIP Reusable Pediatrics >10 kg and <50 kg LNOP DCSC Reusable Adult and Pediatrics >30 kg, for spot check applications 8 CLEANING AND REUSE OF MASIMO LNOP SENSORS Reusable sen
8 sensors/patient masimo SET patient cables 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. Only use Masimo oximetry patient cables for SpO2 measurements. Other patient cables may cause improper Radical pulse oximeter performance.
service/maintenance 9 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. Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only.
9 service/maintenance 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. To charge the battery(s), attach the Handheld unit to the Docking Station. Ensure that AC power is attached to the Docking Station.
9 service/maintenance CAUTION: ■ IF THE RADICAL HAS NOT BEEN CHARGED FOR 1 MONTH OR MORE, THEN RECHARGE THE BATTERY PRIOR TO USE. 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. The Radical Pulse Oximeter is always configured to include the Handheld battery.
9 service/maintenance WARNING: THE DOCKING STATION BATTERY SHOULD BE INSTALLED AND/OR REMOVED FROM DOCKING STATION BY QUALIFIED PERSONNEL ONLY. REPLACING THE BATTERIES ■ Before installing or removing the battery, make sure the AC power cord is removed and power to the pulse oximeter is turned off. 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).
service/maintenance 9 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 fuses, you will need a flat-blade screwdriver (5mm; 3/16”). To replace the fuses: ■ Disconnect unit from AC power. ■ Use the small flat-blade screwdriver and gently pry loose the fuse holder in the right portion of the power entry module.
9 service/maintenance Power-On Self-Test: 1. Connect the monitor to AC power and verify that the AC Power Indicator is lit. If it is not lit verify that the AC mains switch is on. 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. 3. The green Docking Indicator LED is illuminated and the Radical begins normal operation. Key Press Button Test: 1.
service/maintenance 9 Testing with Masimo SET Tester (Optional): 1. Turn the Radical off and then on again. 2. Set the alarm limits to: % SpO2 Pulse Rate High 100 140 Low 90 50 3. Connect the Masimo SET Tester to the Patient Cable Connecter. 4. 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). 5. Verify that the SpO2 measurement is between 79% and 84%. 6.
9 service/maintenance Analog Output Test 1. Disconnect all patient cables and sensors from the Radical. Turn the Radical 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. Connect the positive lead of the voltmeter to pin 9 (Analog Out - % SpO2) of the analog output connector. 3. Enter the menu system and set the "Output", "Analog Output Mode" to "0V Signal".
service/maintenance service and 9 repair REPAIR POLICY Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the unit repaired. WARNING: DO NOT REMOVE THE COVER OF THE MONITOR EXCEPT FOR BATTERY REPLACEMENT. AN OPERATOR MAY ONLY PERFORM MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS MANUAL. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL TRAINED IN THE REPAIR OF THIS EQUIPMENT.
9 service/maintenance warranty 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. 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 oximeter.
accessories 10 accessories The following accessories and re-order parts are available with the Radical Signal Extraction pulse oximeter: ACCESSORIES PART NUMBER RADICAL HANDHELD 1309 RADICAL DOCKING STATION RDS-1 1310 RADICAL DOCKING STATION RDS-1B 1311 RADICAL DOCKING STATION RDS-2 1392 RADICAL HANDHELD LOCK 1395 REPLACEMENT BATTERY RADICAL - HANDHELD 1315 POLE CLAMP 1317 OPERATOR’S MANUAL - ENGLISH 11601 OPERATOR’S MANUAL - GERMAN 11714 OPERATOR’S MANUAL - FRENCH 11715 OPERATOR’S M
accessories 10 ACCESSORIES PART NUMBER SATSHARE CABLE-DO01 1324 SATSHARE CABLE-DO02 1326 SATSHARE CABLE-DO03 1528 SATSHARE CABLE-DO04 1533 SATSHARE CABLE-DS01 1325 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 68 Radical Signal Extraction Pulse Oximeter Operator’s Manual 11601E-0801 Please visit our website, www.masimo.
