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signal extraction pulse oximeter OPERATOR`S

1. 4 23 Second page e der bod eed EP RES 4 23 Thi page Me Eu eee tesis pd cm ttd eld oir AU eed 4 23 Trend Setup s serere PER EEE eaten ee gly Yr epee RE 4 24 Backlight contrast operation 0 20 0 0 cece eect eet eee eee 4 25 Satshare operation iinet pea te o oranes dtd e Boda An dalle eld 4 26 Home mode operations sree douse prie Ris 4 27 Password operation evs ccesiseves gp e e ule e Rr ERR ER de add 4 28 SECTION 5 ALARMS MESSAGES Introduction oec are Oe ub pa eo veneta tdem eus 5 1 Alarm identification 0 0 0 0c cece cece een I 5 1 System messages vice cede sree sad eld aves bes deddeneevet RR ARTE Erde 5 2 Alarm operation tcc crave eee eet eiad E EEEE EUIS YA OP du PAG RS 5 8 Alarm messages isses ces s rete bessere ERR RE bad ded 5 8 SECTION 6 TROUBLESHOOTING Troubleshooting 3 tee roe preme idend Deae ed xk d E RT dm 6 1 SECTION 7 SPECIFICATIONS Radical specifications 5 2 cec ples Lii Rp ERE Red dex v 7 1 Performance o usce sped pao etn Oe Baan PERENNI eect 7 1 Electrical 22i EA A n e aa Hid dee aime a USE datus 7 1 Environmental oe oened akepa a a EI UEM ope 7 2 Physical characteristics sororis ieme g uE EE EE E 7 2 Serial interface specifications isssssesesssssssse ee 7 3 Serial Printer Setup one E TERE EEIE ERAS n 7 4 Analog output nurse call specifications aaa 7 5 Analog Output ise 2 nr prre Rt dey VESPA RT RU PER ae 7 6 Calibration 3 5 ox deed decor pa
2. SENSITIVITY Note When using the Maximum Sensitivity setting the SENSOR OFF MAX detection performance may be compromised Note In Custom mode see Section 4 Operation the unit will remain in Normal or APOD setting after a power cycle Maximum Sensitivity will automatically reset to Normal Sensitivity after a power cycle In Neo or Adult mode see Section 4 Operation the unit will reset the sensitivity to the hospital specified setting Normal or APOD after a power cycle Press the Rotate Display button to reconfigure the display screen in a C ROTATE vertical or horizontal format The display rotates counter clockwise in 90 degree increments SECOND PAGE Press the Next Menu Page button to access the second page of NEXT MENU selections g PAGE Press and hold for 6 seconds to toggle between Traditional User Interface and the Simplified User Interface Enter password when prompted The Radical will retain this setting after a power cycle TREND f Wh DISPLAY Press the Trend Display button to show the trend data on the display Press the Increase Loudness button to increase the volume of the pulse beep Seven levels of volume exist INCREASE 4 LOUDNESS DECREASE Press the Decrease Loudness button to decrease the volume of the LOUDNESS pulse beep The lowest volume level will silence the pulse beep Radical Signal Extraction Pulse Oximeter Operator s Manual operation
3. WARNING WHEN DEEP DISCHARGING THE HANDHELD OR DOCKING STATION BATTERY MAKE SURE THAT THE DEVICE HAS BEEN REMOVED FROM SERVICE UNTIL FULL BATTERY CAPABILITY CAN BE RESTORED 4 20 Radical Signal Extraction Pulse Oximeter Operator s Manual operation EF 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 SpO pulse rate Pl 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 87 hours and 18 days 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 The Radical only stores data in the trend memory while the device is turned on and the trend data remains in memory until the memory fills up or is cleared by the user CAUTION CHANGING THE DATE AND TIME OF THE SYSTEM CLOCK OR CHANGING THE TREND PERIOD WILL ALSO CLEAR THE DATA IN THE TREND MEMORY The following table outlines the trend capacity for sample Trend Period settings TREND PERIOD TREND MEMORY CAPACITY 2 SECONDS MINIMUM OF 87 HOURS 3 5 DAYS 10 SECONDS TYPICALLY 435 HOURS 18 DAYS The Trend display can be configured to display any two of the three available trend parameters SpO pulse rate or Pl The unit
4. n operation Password operation The Radical password is 2 3 1 To enter the password use the touch key control buttons to the right or bottom of the LCD display and press the buttons in the sequence shown in the following figure x x x 3 Thenpress gt 3 8 First press gt o 2 Finally press gt To return to normal operating mode set the General Home Use parameters to No 4 28 Radical Signal Extraction Pulse Oximeter Operator s Manual alarms messages dB Introduction The following section outlines system alarms and messages displayed on the LCD Screen Please become thoroughly familiar with this information before operating the pulse oximeter Alarm identification The Radical 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 Audible alarms may be silenced without affecting the operation of visual alarms Three levels of alarm priority are implemented high medium and low priority The following table outlines the alarm priority specifications ALARM DESCRIPTION HIGH Audible and visual alarms for low saturation SpO range 1 100 and PRIORITY pulse rate pulse rate range 25 240 bpm Audible and visual alarms for system failures Sensor Failure and Disconnect Audible and visual alarms for high satu
5. 20 accuracy Saturation 70 to 100 No Motion Adults Pediatrics 2 digits Neonate 3 digits Motion Adults Pediatrics 3 digits Neonate 3 digits Low Perfusion Adults Pediatrics 2 digits Neonate 3 digits Pulse Rate Accuracy pulse rate 25 240 bpm No Motion Adults Pediatrics Neonate 3 digits Motion Adults Pediatrics Neonate 5 digits Low Perfusion Adults Pediatrics Neonate 3 digits resolution Saturation Sp0 1 Pulse Rate bpm 1 bpm ELECTRICAL standalone AC Power requirements 100 240 VAC 47 63 Hz Power consumption 55 VA Fuses 1 Amp Fast Acting Metric 5x20mm 250V batteries Handheld Type NiMH Capacity 8 hours45 Charging time 3 hours Docking Station RDS 1B RDS 3B Type NiMH Capacity 12 hours45 Charging time 6 hours Radical Signal Extraction Pulse Oximeter Operator s Manual 7 1 E specifications ENVIRONMENTAL Operating Temperature 41 F to 104 F 5 C to 40 C Transport Storage Temperature 40 F to 158 F 40 C to 70 C Operating Humidity 5 to 95 non condensing Operating Altitude 1060 mbar to 500 mbar pressure 1000 ft to 18 000 ft 304 m to 5 486 m PHYSICAL CHARACTERISTICS dimensions Handheld 8 9 x 3 3 x 2 1 22 6 cm x 8 4cm x 5 3 cm Standalone 3 5 x 10 5 x 7 7 8 9 cm x 26 7cm x 19 6cm weight Handheld 1 3 Ibs 0 59 kg Docking Station RDS 1 RDS 2 RDS 3 RDS 4 2 5 lbs 1 14
6. Connect the sensor to the unit or patient cable with the logos lining up make sure itis a firm connection Press the Power Standby button to turn the oximeter on Make sure the display window is free of alarm and system failure messages see Section 5 Alarm Identification 9 On the display verify The high and low alarm limits for SpO and pulse rate Wi The readings for SpO and pulse rate NOTE may appear on the numeric display until the SpO and pulse rate readings have stabilized approximately 10 seconds Radical Signal Extraction Pulse Oximeter Operator s Manual 4 1 E operation 10 11 12 13 14 15 16 17 4 2 Verify that the patient alarms are functional by setting the high and low SpO and pulse rate alarm limits beyond the patient readings Wi An alarm tone sounds BI The violated alarm limit and reading flash on the display B6 The red alarm indicator flashes on the Docking Station standalone operation 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 The alarm indicator flashes Disconnect the sensor from the patient cable or oximeter Confirm that NO SENSOR appears in the message area of the graphic display Verify alarm silence operation Wi Create an alarm condition by lowering the SpO or pulse rate high alarm limits beyond the pati
7. DURING SATSHARE OPERATION DO NOT USE THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC PURPOSES INSTEAD USE THE PLETH WAVEFORM DISPLAYED ON THE RADICAL SCREEN W TO AVOID EXCESSIVE BATTERY DISCHARGING DO NOT CONNECT ANY EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL IS CONNECTED TO THE AC MAIN POWER SUPPLY W TO ENSURE THAT THE SAFETY LEVEL DURING DEFIBRILLATION IS MAINTAINED MAKE SURE THAT THE SATSHARE CABLE CONNECTOR IS PROPERLY SECURED AT THE DOCKING STATION B ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED 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 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 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 Radical Signal Extraction Pulse Oximeter Operator s Manual
8. Viatical signal extraction J IET W 4nd Tu OPERATOR S Radical Signal Extraction Pulse Oximeter OPERATOR S MANUAL The Radical Operating Instructions 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 its proper use Do not operate the Radical Pulse Oximeter without completely reading and understanding the instructions in this manual NOTICE Purchase or possession of this device does not carry any express or implied license to use this device with replacement parts which would alone or in combination with this device fall within the scope of one of the patents relating to this device CAUTION FEDERAL LAW U S RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Masimo Corporation 40 Parker Irvine CA 92618 C USA 0123 Tel 949 297 7000 Fax 949 297 7001 www masimo com EU Authorized Representative for Masimo Corporation EC REP MDSS GmbH Schiffgraben 41 30175 Hannover Germany Tel 49 511 62 62 86 30 Fax 49 511 62 62 86 33 RETA MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC 7 SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH t US UL 60601 1 CAN CSA C22 2 No 601 1 C
9. Nurse Call Common of the analog output connector on the Radical Connect the positive lead of the multi meter to pin 6 Nurse Call Normally Open of the analog output connector and measure that the resistance is greater than 1 MQ open circuit Trigger an alarm on the monitor e g by disconnecting a sensor after it was measuring data and verify that the resistance is less than 35 ohms Radical Signal Extraction Pulse Oximeter Operator s Manual d service and 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 1 of the analog output connector 3 Enter the menu system and set the Output Analog 1 to OV Signal Verify that the voltmeter measures a voltage of approximately OV 4 Enterthe menu system and set the Output Analog 1 to 1V Signal Verify that the voltmeter measures a voltage of approximately 1 0V 5 Repeat Steps 3 and 4 with the positive lead of the voltmeter connected to pin 15 Analog 2 6 Connect a patient cable and sensor and verify that the voltage on pins 9 and 15 are between OV and 1 0V while measuring a saturation and pulse rate Battery Test 1 Fully charge the Radical by placing the Handheld into the Docking Station and connect
10. TYPES SpO SpO PULSE RATE PULSE RATE HIGH LOW HIGH LOW ADULT Off 90 140 BPM 50 BPM LIMITS NEONATAL 100 90 180 BPM 100 BPM LIMITS CUSTOM Off 90 140 BPM 50 BPM LIMITS NOTE Limits are set at the factory to the values listed in this table Once Custom values are changed by the user they will be retained after a power cycle Adult and Neo settings can be changed via a password protected screen to specific hospital unit requirements In enabled any values changed by the user will be returned to the default values after a power cycle Radical Signal Extraction Pulse Oximeter Operator s Manual Ed operation Display MENU ITEMS DESCRIPTION Three views are available Pleth and Signal IQ Numbers and Pleth Only PLETH SIGNAL IQ Shows the SpO 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 PLETH ONLY Shows the SpO and pulse rate numbers on the left or top of the screen and the plethysmograph 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 pulsatil
11. specifications Ea Serial RS 232 RDS 1 RDS 1B RDS 3 RDS 3B RDS 4 Nurse Call Analog Output RDS 1 RDS 1B RDS 3 RDS 3B HP Vuelink Spacelabs Universal Flexport RadNet RDS 1 RDS 1B RDS 3 RDS 3B compliance EMC Compliance EN60601 1 2 Class B Equipment Classification IEC 60601 1 UL 60601 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 Mode of Operation Continuous 1 The Radical with LNOP Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70 100 SpO against a laboratory oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population weight 2 The Radical with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory CO Oximeter and ECG monitor This var
12. INDICATIONS WILL BE VISUAL DISPLAYS AND SYMBOLS RELATED TO THE ALARM CONDITION NO ALARM TONE WILL SOUND Radical Signal Extraction Pulse Oximeter Operator s Manual operation EF Alarms Ccon t MENU ITEMS 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 VOLUME retains the Alarm Volume setting upon a power cycle NOTE For home use set the alarm level to level 4 This menu allows the users to set an audible saturation delay The delay can be set to either 0 5 or 10 seconds The delay setting only affects saturation alarms indications DELAY Note In Custom mode see Section 4 Operation the unit will retain the Alarm Delay setting after a power cycle In Neo or Adult mode see Section 4 Operation the unit will reset the Alarm Delay to the hospital specified setting after a power cycle The Radical stores three types of modes Adult Neonatal or Custom limits Adult and Neonatal must be initially set and enabled via password protected screen before they can be selected CUSTOM Any changes to settings on the Alarm menu will be retained after a power cycle ADULT Any changes to settings on the Alarm menu will be reset to pre defined Adult defaults after a power cycle NEO MODE Any changes to settings on the Alarm menu will be reset to pre defined Neonatal defaults after a power cycle t
13. NOT AGREE TO THE TERMS OF THIS AGREEMENT PROMPTLY RETURN THE ENTIRE PACKAGE INCLUDING ALL ACCESSORIES IN THEIR ORIGINAL PACKAGE WITH YOUR SALES RECEIPT TO MASIMO FOR A FULL REFUND 1 Grant of License In consideration of payment of the license fee which is part of the price paid for this product MASIMO grants to Purchaser a nonexclusive nontransferable license without right to sublicense to use the copy of the incorporated software firmware and documentation in connection with Purchaser s use of the Masimo Products for their labeled purpose MASIMO reserves all rights not expressly granted to Purchaser 2 Ownership of Software Firmware Title to ownership of and all rights and interests Radical Signal Extraction Pulse Oximeter Operator s Manual service and maintenance dn in any MASIMO software and or firmware and the documentation and all copies thereof remain at all times vested in MASIMO Corporation licensor to MASIMO and they do not pass to Purchaser 3 Assignment Purchaser shall not assign or transfer this License in whole or in part by operation of law or otherwise without MASIMO s prior written consent any attempt without such consent to assign any rights duties or obligations arising hereunder shall be void 4 Copy Restrictions The software firmware and the accompanying written materials are copyrighted Unauthorized copying of the software including software that has been modified merged or included w
14. be changed by the user and retained through the power cycle Wi Adult Neo these settings can be selected to revert to factory or hospital defined values for Adult or Neonatal after a power cycle The following outlines the default values the Radical reverts to after a power cycle FACTORY DEFAULT SETTINGS OPTION DEFAULT SETTING LCD SCREEN ILLUMINATION AC Power Set to maximum level 4 Battery Power Set to off SENSITIVITY Set to normal mode CUSTOM USER DEFINED SETTINGS This mode is indicated by Mode Custom on the Alarms menu The following table outlines the settings that may be changed by the user and the Radical will remember after a power cycle OPTION DEFAULT SETTING DISPLAY VIEW AND CONTRAST Set to pre power down setting AVERAGING TIME Set to pre power down setting FASTSAT Set to pre power down setting HOME USE Set to pre power down setting INTERFACE ALARMS Set to pre power down setting SATSHARE NUMBERS Set to pre power down setting POWER SAVE Set to pre power down setting DATE AND TIME FORMAT Set to pre power down setting LANGUAGE Set to pre power down setting ANALOG OUTPUT Set to pre power down setting SERIAL OUTPUT PORT MODE Set to pre power down setting Radical Signal Extraction Pulse Oximeter Operator s Manual a setup 8 4 OPTION DEFAULT SETTING PULSE BEEP VOLUME Set to pre power down setting TREND DISPLAY PARAMETERS Set to pre power down se
15. 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 p 9 Select the Previous icon to increase or toggle the parameter t PREVIOUS settings gy NEXT Select the Next icon to decrease or toggle the parameter settings MENU TREE This section gives an overview of the menu selections that are available To navigate through the menus use the touch key icons and control buttons located on the front panel of the Handheld to the right of the LCD display The following sub sections describe each menu item in more detail SpO high low limit Pulse rate high low limit bpm Silence ALARMS Volume Delay Mode View Trend DISPLAY Contrast Language Default Radical Signal Extraction Pulse Oximeter Operator s Manual 4 11 E operation GENERAL Averaging Time FastSat Home Use Interface Alarms SatShare Numbers Power Save CLOCK Time hour minute seconds Time display format Day Month Year Format ABOUT Software Version CONFIG Rapid Desat Limit OUTPUT Serial Analog 1 Analog 2 Nurse Call Polarity SERVICE Handheld Battery Deep Discharge DS Battery Deep Discharge Radical Signal Extraction Pulse Oximeter Operator s
16. light conditions may result in inaccurate measurements Radical Signal Extraction Pulse Oximeter Operator s Manual 8 1 sensors amp patient cables SENSOR APPLICATION SITE Unless indicated otherwise in the directions for use reposition reusable sensors at least every 4 hours and adhesive sensors at least every 8 hours LNOP REUSABLE SENSORS LNOP sensors must be used in conjunction with PC cables Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate LNOP DCI gt 30 kg 2 3 3bpm 5bpm 2 3 bpm LNOP DCIP 10 50 kg 2 3 3bpm 5bpm 2 3 bpm LNOP Yl gt 1kg 2 3 3bpm 5bpm N A N A LNOP TC I 30 kg x 3 596 N A 3 bpm N A x 9 596 3 bpm LNOP DC 195 gt 30 kg 2 3 3bpm 5bpm 2 3 bpm LNOP DCSC 30kg 2 3 3bpm 5 bpm 2 3 bpm LNOP TF I gt 30 kg 2 N A 3 bpm NA 2 3 bpm Note The LNOP TF and TC I sensors were not validated under motion conditions LNOP ADHESIVE SENSORS LNOP sensors must be used in conjunction with PC cables Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy SENSOR Range No Motion Motion NoMotion Motion Saturation Pulse Rate LNOP Adt gt 30 kg 2 3 3bpm 5bpm 2 3 bpm LNOP Adtx gt 30 kg 2 3 3bpm 5bpm 2 3 bpm LNOP Pat 10
17. on the Radical display whenever the 4 FastSat FASTSAT Radical is set to operate in the FastSat mode SATURATION The Saturation Alarm Limits Display shows the upper and lower E ALARM LIMITS saturation alarm limits When an alarm limit is reached or SU DISPLAY exceeded the SpO value and the violated limit flashes The alarm status indicator a bell can be shown with or without a slash It flashes when an alarm condition is present When the A alarm is silenced using the Alarm Silence Button an alarm status e ALARM STATUS indicator with a slash and a timer is shown to indicate that the WT ou INDICATOR alarm is temporarily silenced When the alarm is silenced through A All Mute menu selection which is permanent until power is cycled or deselected using menu an alarm status indicator with a slash is shown to indicate that alarm has been silenced SYSTEM No Sensor MESSAGE The system messages generated by the instrument are displayed AREA in the System Message Area See Section 5 System messages The Max or APOD sensitivity icon is shown on the Radical display D Max SENSITIVITY to indicate if the Radical is set to operate in Normal sensitivity VL APOD Maximum sensitivity or Adaptive Probe Off Detection mode When in Normal mode this area will appear blank The Battery Status Indicators show the capacity of the Radical x BATTERY Handheld and optional Docking Station batteries The indicator 6 STATUS flashes when less than 15 m
18. perfusion and or motion They are as follows Wi Normal Sensitivity This is the recommended mode for patients that are experiencing some compromise in blood flow or perfusion It is advisable for care areas where patients are observed frequently such as ICU s Wi Adaptive Probe Off Detection APOD This is the recommended start up monitoring mode for most patients with acceptable perfusion or where a more robust sensor off detection is desired It is the suggested mode for care areas where patients are not visually monitored continuously This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient W Maximum Sensitivity MAX This mode is recommended for patients with low perfusion or when the low perfusion or low signal quality message is displayed on the screen in APOD or normal sensitivity mode This mode is not recommended for care areas where patients are not monitored visually such as general wards It is designed to interpret and display data at the measuring site when the signal may be weak due to decreased perfusion When a sensor becomes detached from a patient it will have compromised protection against erroneous pulse rate and arterial saturation readings CAUTION WHEN USING THE MAXIMUM SENSITIVITY SETTING THE PERFORMANCE OF THE SENSOR OFF DETECTION MAY BE COMPROMISED IF THE UNIT IS IN THIS SETTING AND THE SENSOR B
19. pressing the Scroll Left button will scroll the displayed data by 1 hr to the left t V SECOND PAGE NEXT MENU Press the Next Menu Page button to access the next page of PAGE menu selections Press the Zoom button to change the time scale of the trend view The available time scales are 24 hrs 12 hrs 8 hrs 4 hrs 2 hrs 1 ZOOM hr 30 minutes 10 minutes 1 minute and 20 seconds The Zoom button uses the last recorded data point as the zoom reference point In other words the last recorded data point is always shown as the right most data point on the display ZOOM FROM Press the Zoom from Left button to zoom into the data set while LEFT keeping the data point that is shown on the right side of the trend graph as the zoom reference point Press the Zoom from Right button to zoom into the data set while ZOOM FROM keeping the data point that is shown on the left side of the trend Li RIGHT graph as the zoom reference point THIRD PAGE NEXT MENU Press the Next Menu Page button to return to the first page of PAGE menu selections TREND SETUP Press the Trend Setup button to enter the Trend Setup Menu Press the Histogram button to display the selected data set the HISTOGRAM data set shown in the trend view in histogram format CLEARTREND Press the clear Trend Data button to clear the data stored in the DATA trend memory amp E ru Lr Radical Signal
20. sensitivity to the hospital specified setting Normal or APOD after a power cycle APOD ROTATE Press the Rotate Display button to reconfigure the display screen in 5 DISPLAY a vertical or horizontal format The display rotates counter clockwise in 90 degree increments SECOND PAGE Press the Next Menu Page button to access the first page of E NEXT MENU selections g PAGE Press and hold for 6 seconds to toggle between Traditional User Interface and the Simplified User Interface Enter password when prompted The Radical will retain this setting after a power cycle A EN Press the Alarm Menu Access button to enter the alarm settings menu INCREASE Press the Increase Loudness button to increase the volume of the pulse beep 4 LOUDNESS Seven levels of volume exist DECREASE Press the Decrease Loudness button to decrease the volume of the 4 LOUDNESS pulse beep The lowest volume level will silence the pulse beep Radical Signal Extraction Pulse Oximeter Operator s Manual n 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 MAIN MENU S
21. setting below the newly entered high alarm limit setting Radical Signal Extraction Pulse Oximeter Operator s Manual Ed operation Alarms Ccon t MENU ITEMS DESCRIPTION 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 can be set for these durations 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 NOTE The alarm silence period is reset to 120 seconds or 90 seconds in neonatal mode 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 As an indicator that the system is set to All Mute the Alarm Status Indicator is shown as a bell with a slash through it ALL MUTE WITH AUDIBLE REMINDER All patient alarm conditions are silenced Only system alarms will be indicated by an audible alarm As a reminder a single audible alarm will occur every three minutes As an indicator that the system is set to All Mute the Alarm Status Indicator is shown as a bell with a slash through it SILENCE WARNING IF AN ALARM CONDITION OCCURS WHILE THE ALARM SILENCE PERIOD IS SET TO ALL MUTE THE ONLY ALARM
22. the level of illumination simply press the Backlight Contrast button located on the front panel of the Handheld When the Radical Handheld unit is released from the Docking Station the illumination of the LCD screen automatically reverts to the lowest level to conserve battery power To select a different level of illumination press the Backlight Contrast button again In the Handheld mode three levels of illumination are available When the Handheld unit is re attached to the Docking Station as well as when the Radical is powered on in the Standalone configuration the backlight is automatically set to the maximum illumination when the unit is AC line powered To change the contrast of the LCD screen select the Contrast parameter of the Display menu While changing the contrast setting the screen will refresh to reflect the current setting The contrast of the LCD screen can also be changed by depressing and holding the Backlight Contrast button located on the front panel of the Handheld While holding the Backlight Contrast button the screen will refresh to reflect the current setting Release the button at the desired setting Radical Signal Extraction Pulse Oximeter Operator s Manual E operation 4 26 Satshare operation When the SatShare cable is connected to the Radical and to a multiparameter patient monitor the Radical automatically starts to operate in the SatShare mode In the SatShare mode Radical operates as follo
23. to an AC outlet controlled by a switch Verify the AC power voltage and frequency before use Verify that the power source can provide adequate power rating as indicated on the rear panel of the Radical Docking Station The Radical Pulse Oximeter is designed to operate on 100 to 240VAC 47 63 Hz The device is rated at 55 VA max Connect a hospital grade power cable to the power entry module of the Radical unit IEC 320 connector type at the Radical Connect the power cable to an AC power source Ensure that the unit is adequately powered by verifying that the AC power indicator on the Docking Station is illuminated CAUTION M CONNECT THE OXIMETER ONLY TO A HOSPITAL GRADE RECEPTACLE W DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR FROM THE POWER PLUG W DONOT USE EXTENSION CORDS OR ADAPTERS OF ANY TYPE THE POWER CORD AND PLUG MUST BE INTACT AND UNDAMAGED W USE THE POWER CORD AS THE MEANS TO DISCONNECT THE DEVICE FROM THE MAINS POWER SUPPLY Radical Signal Extraction Pulse Oximeter Operator s Manual 3 1 a setup W F 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 W TO ENSURE PATIENT ELECTRICAL ISOLATION CONNECT ONLY TO OTHER EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS mM DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL SWITCH OR DIMM
24. 01 1367 SATSHARE CABLE NK01 1368 SATSHARE CABLE NK02 1366 SATSHARE CABLE OH01 1646 SATSHARE CABLE OH02 1840 SATSHARE CABLE PM01 1323 SATSHARE CABLE SLO1 1362 SATSHARE CABLE SL02 1322 SATSHARE CABLE SM01 1605 SATSHARE EXTENSION CABLE 11901 RADICAL USER MANUAL DANISH 11902 RADICAL USER MANUAL DUTCH 11601 RADICAL USER MANUAL ENGLISH 11715 RADICAL USER MANUAL FRENCH 11714 RADICAL USER MANUAL GERMAN 11716 RADICAL USER MANUAL ITALIAN 11717 RADICAL USER MANUAL PORTUGUESE 11718 RADICAL USER MANUAL SPANISH 11903 RADICAL USER MANUAL SWEDISH 12114 RADICAL SERVICE MANUAL 30475 RADICAL HANDHELD CASE 1593 MASIMO TESTER 1795 MASIMO TESTER WITH CABLE Please visit our website www masimo com for updated information about accessories Radical Signal Extraction Pulse Oximeter Operator s Manual 11601 2526P 0807 10 1 Nhs tl www masimo com Masimo SET designation on both the sensors and monitors to ensure accurate pulse oximetry when needed most Instruments and sensors containing Masimo SET technology are identified with the Masimo SET logo Look for the 9 f d I 0 I 2007 Masimo Corporation Masimo Radical Discrete Saturation Transform DST Satshare SET LNOP LNCS and LNOPv are federally registered trademarks of Masimo Corporation RadNet RadicalScreen Signal IQ FastSat FastStart and APOD are trademarks of Masimo Corporation
25. 50 kg 2 3 3bpm 5bpm 2 3 bpm LNOP Pdix 10 50 kg 2 3 3bpm 5 bpm 2 3 bpm LNOP Neo lt 10 kg 3 3 3bpm 5bpm 3 3 bpm LNOP NeoPt lt 1kg 3 3 3bpm 5bpm 3 3 bpm lt 3kg 3 3 3bpm 5bpm 3 3 bpm LNOP Neo L gt 40 kg 2 3 3bpm 5bpm 2 3 bpm LNOP NeoPt L lt 1kg 3 3 3bpm 5bpm 3 3 bpm LNOP Inf L 3 20 kg 2 3 3bpm 5bpm 2 3 bpm LNOP Neo ciokg 3 3 s3bpm 5bpm 23 s3bpm Bridge LNOP NeoPt cao 23 3 3bpm s5bpm 3 3 bpm Bridge Radical Signal Extraction Pulse Oximeter Operator s Manual sensors amp patient cables LNOP SPECIALTY SENSORS LNOP sensors must be used in conjunction with PC cables Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy SENSOR i A Range No Motion Motion No Motion Motion Saturation Pulse Rate LNOP Hi Fi 3 10kg 3 3 3bpm 5 bpm 3 3 bpm Inf Ped 10 30kg 2 3 3bpm 5 bpm 2 3 bpm LNOP Hi Fi 3 kg 3 3 3bpm 5bpm 3 3 bpm Neo Adult gt 30 kg 2 3 3bpm 5bpm 2 3 bpm Saturation Accuracy Pulse Rate Low Perfusion Accuracy 60 80 70 100 80 100 Accuracy Saturation Pulse Rate SENSOR LNOP Blue 2 5 30kg 4 3 3 3 3 bpm 3 3 bpm Saturation Accurac Pulse Rate Accurac i SENSOR y Y Low Perfusion Accuracy No Motion Motion No Motion Motion Saturation Pulse
26. 7 5 EA specifications 7 6 ANALOG OUTPUT The 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 Depending on the configuration of the Output menu SpO pulse rate pleth waveform or Signal IQ parameters are output continuously on the Analog 1 and Analog 2 channels The output signals vary from approximately 0 to 1 volt in a linear fashion NOTE The actual Analog 1 and Analog 2 output voltage that are generated may not exactly range between 0 0V to 1 0V A variance of 40 mV is acceptable CALIBRATION For measurement device calibration purposes the analog output signals can be set to either 0 Volts or 1 Volt in the menu system under Output Analog Output Mode Calibrate your analog recording system to those levels before use NURSE CALL The nurse call feature is available when the Radical is operating in its standalone configuration The nurse call feature on the Radical is based on the relay closing or opening depending on alarm Low Signal IQ events or both For maximum flexibility either normally open pin 6 or normally closed pin 7 signals are available Only qualified personnel should connect one of these two signals and common pin 12 to a hospitals nurse call system During an alarm condition or a Low Signal IQ event depending on the configuration of the output menu the normally open pin will be connected t
27. ALUES W DURING SATSHARE OPERATION THE AUDIBLE ALARMS MAY BE MUTED ON RADICAL WHEN THE AUDIBLE ALARM IS MUTED INDICATED BY THE BELL WITH A SLASH THROUGH IT ON RADICAL USE THE MULTIPARAMETER MONITOR FOR AUDIBLE ALARM INDICATION M DURING SATSHARE OPERATION DO NOT USE THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC PURPOSES INSTEAD USE THE PLETH WAVEFORM DISPLAYED ON THE RADICAL SCREEN W TO AVOID EXCESSIVE BATTERY DISCHARGING DO NOT CONNECT ANY EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL PULSE OXIMETER IS CONNECTED TO THE AC MAINS POWER SUPPLY M TO ENSURE THAT THE SAFETY LEVEL DURING DEFIBRILLATION IS MAINTAINED MAKE SURE THAT THE SATSHARE CABLE CONNECTOR IS PROPERLY SECURED AT THE DOCKING STATION MONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED WARNING EXTERNAL DEVICE CONNECTIONS TO THE SATSHARE PORT MUST BE IEC 60601 1 1 COMPLIANT Philips VueLink setup CAUTION SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED 1 Select the Philips 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 Philips monitor rack 4 The SpO and pulse rate values will automatically appear on the Philips monitor 5 In order for the pleth
28. ATION BY QUALIFIED PERSONNEL ONLY Radical Signal Extraction Pulse Oximeter Operator s Manual service and maintenance dn 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 fuse s you will need a flat blade screwdriver bmm 3 16 To replace the fuses 1 Disconnect unit from AC power 2 Remove AC power code from the power entry module at the rear of the docking station 3 Use the small flat blade screwdriver and gently pry loose the fuse in the left portion of the power entry module exposing the fuse holder Using the small flat blade screwdriver gently pry out the fuse holder Note how the fuses are placed in the fuse holder for installation of the new fuse s To remove the fuse s from the fuse holder use the edge of the screwdriver blade to pry against the bottom of the metal portion of the fuse where it is secured to the glass portion of the fuse 7 Place the fuse s 1 Amp Metric fast acting 5x20mm 250V in the fuse holder properly orienting the fuses 8 Slide the fuse holder back into the power entry module and press firmly to make sure itis completely seated 9 Close the fuse cover and press gently until it seats completely flush with the back of the docking station 10 The unit is ready to be reconnected to AC power NOTE If the fuses blow shortly after replacement the unit req
29. Accuracy Low Perfusion Accuracy SENSOR Range No Motion Motion NoMotion Motion Saturation Pulse Rate qu s 30 kg 276 3 3bpm 5bpm 2 3 bpm LNCS Patx z LNCS Pdb 3 10 50 kg 276 3 3bpm 5 bpm 2 3 bpm LNCS Inf L LNCS Inf 3 20kg 276 3 3bpm 5 bpm 2 3 bpm LNCS Inf 3 LNCSNeoL lt 3kg 3 3 3bpm 5bpm 3 3 bpm LNCS Neo LNCS Neo 3 gt 40 kg 2 3 3 bpm x 5 bpm 396 x 3 bpm LNCS NeoPt L LNCS NeoPt 1kg 3 3 3bpm 5 bpm 3 3 bpm LNCS NeoPt 3 CLEANING AND REUSE OF MASIMO SENSORS Reusable sensors can be cleaned per the following procedure 1 Remove the sensor from the patient 2 Disconnect the sensor from the monitor 3 Wipe the entire sensor clean with a 70 isopropyl alcohol pad 4 Allow the sensor to air dry before returning it to operation REATTACHMENT OF SINGLE USE ADHESIVE SENSORS Wi Single use sensors may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin 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 SINGLE USE SENSORS ON THE SAME PATIENT CAUTIONS M DO NOT ATTEMPT TO REPROCESS RECONDITION OR RECYCLE ANY MASIMO SENSORS AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS
30. Arbitrator MEAS Proprietary Algorithm 4 CONF MEAS Proprietary Algorithm 5 CONF Masimo SET DST Roh wi F NEOA TANT H PAN Adaptive Output Mir His Fitter Power RD Signal Reference Generator Signal Trial Saturation SpOz 95 Power 30 40 50 60 70 80 90 95 100 ry SpO gt ra 1 6 Radical Signal Extraction Pulse Oximeter Operator s Manual System description pe Introduction Radical provides the functionality of three pulse oximeters in one Wi The Radical is a fully featured Handheld pulse oximeter Wi The Radical is a fully featured standalone pulse oximeter Wi The Radical interfaces to the SpO input module of multiparameter patient monitors to upgrade conventional pulse oximetry technology to Masimo SET technology The Handheld portion of the Radical contains the majority of the pulse oximeter features All pulse oximetry measurement information as well as device status data is displayed on the Handheld LCD screen All user input is handled through the control buttons on the front panel The sensor cable connector is located on the Radical Handheld oximeter The Handheld oximeter snaps into the Radical Docking Station to provide a fully featured standalone pulse oximeter The Docking Station connects to AC power for standalone operation or charging of the Handheld An optional Docking Station battery is available The standalone Radical features nurse call ana
31. CAL CONFIGURATION OPERATION MODE MINIMUM RUN TIME Power Save yes HANDHELD ONLY o Backlight turned off 4 hrs Power Save no TANDALONE 1h D Backlight turned on i Configuration 2 Radical configured to include the Handheld and the Docking Station battery RADICAL CONFIGURATION OPERATION MODE MINIMUM RUN TIME Power Save yes STANDALONE Backlight turned off 12 hrs Power Save no STANDALONE Backlight turned on ernis Radical Signal Extraction Pulse Oximeter Operator s Manual 9 3 d service and maintenance REPLACING THE BATTERIES Wi 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 1 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 out the battery Take a new battery and place it in the compartment Tighten the closure screw go FP eS DN Place Handheld into Docking Station turn on line power and charge battery according to Section 9 Battery Operation and Maintenance CAUTION FOLLOW LOCAL GOVERNING GUIDELINES FOR PROPER DISPOSAL OF INTERNAL BATTERIES DO NOT INCINERATE WARNING THE DOCKING STATION BATTERY SHOULD BE INSTALLED AND OR REMOVED FROM DOCKING ST
32. ECOMES DISLODGED FROM THE PATIENT THE POTENTIAL FOR FALSE READINGS MAY OCCUR DUE TO ENVIRONMENTAL NOISE SUCH AS LIGHT VIBRATION AND EXCESSIVE AIR MOVEMENT Radical Signal Extraction Pulse Oximeter Operator s Manual n operation 4 8 Touch key control button and icons 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 Traditional user interface FIRST PAGE Press the Next Menu Page button to access the second page of NEXT MENU selections i PAGE Press and hold for 6 seconds to toggle between Traditional User Interface and the Simplified User Interface Enter password when prompted The Radical will retain this setting after a power cycle MENU access Press the Menu Access button to enter the main menu Press the Sensitivity button to toggle between the Normal APOD and Maximum Sensitivity modes Use the Normal Sensitivity setting for typical monitoring purposes Use the APOD setting where there is a high probability of the sensor becoming detached Use the Maximum Sensitivity setting for patients with low perfusion or when the low perfusion message is displayed on the screen in APOD or normal os sensitivity mode The default is APOD
33. ELECTION The top menu category uses the following four menu selections and touch key control buttons and icons EXIT Select the Exit icon to exit the main menu SELECT Select the Select Category icon to select the highlighted menu CATEGORY item and enter the next level menu Select the Previous icon to scroll through the menu items PREVIOUS without selecting them Once a menu item is highlighted enter the menu by pressing the Select Category icon Select the Next icon to scroll through the menu items without NEXT selecting them Once a menu item is highlighted enter the menu by pressing the Select Category icon MENU CATEGORIES Once a menu category has been selected a new set of menu selections and icons are displayed Select the Exit icon to exit the menu category and return to the EXIT previous menu zl EDIT Selectthe Edit Parameter icon to select the highlighted parameter for PARAMETER editing Select the Previous icon to scroll through the parameters Once a PREVIOUS parameter is highlighted edit the parameter by pressing the Edit Parameter icon 4 Select the Next icon to scroll through the parameters Once a NEXT parameter is highlighted edit the parameter by pressing the Edit Parameter icon 4 10 Radical Signal Extraction Pulse Oximeter Operator s Manual operation Ey EDITING A PARAMETER Once a parameter has been selected for editing a new set of menu selections and icons are
34. ER INITIAL BATTERY CHARGING Before use the Radical Handheld battery and the optional Docking Station battery needs to be fully charged To charge the batteries attach the Handheld unit to the Docking Station and plug in the AC power cord Verify that the batteries are charging The battery charging LED indicators on the Docking Station flash prior to charging and remain illuminated while the batteries are charging Refer to Section 9 Battery Operation and Maintenance for proper battery charging INITIAL INSTALLATION 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 The Radical Handheld Docking Station or Standalone should not be operated outside the following environmental conditions OPERATING ENVIRONMENTAL CONDITIONS TEMPERATURE 5 C to 40 C 41 F to 104 F HUMIDITY 5 to 95 non condensing 1060 mbar to 500 mbar pressure OPERATING ALTITUDE 1000 ft to 18 000 ft 304 m to 5 486 m Radical Signal Extraction Pulse Oximeter Operator s Manual setup B Monitor setup The Radical maintains three types of default values which will automatically reverts to after a power cycle Wi Factory these options are restored to factory values Wi Custom these settings can
35. ET Tester Optional 1 2 10 11 Turn the Radical off and then on again Set the alarm limits to SpO Pulse Rate High 100 140 Low 90 50 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 Verify that the pulse rate measurement is between 55 bpm and 65 bpm Verify that an audible alarm occurs and that the SpO measurement and the low SpO alarm are flashing Press the Alarm Silence button once and verify that the alarm is silenced Wait 120 seconds and verify that the alarm silence times out and the audible alarm is activated again Press the Increase Loudness button several times and verify that the loudness of the pulse beep tone increases Press the Decrease Loudness button and verify that the loudness of the pulse beep tone decreases Press the Decrease Loudness button and verify that the loudness of the pulse beep tone can be turned off Nurse Call Test 1 Disconnect the patient cable or the Masimo SET Tester from the Radical and turn the instrument on Ensure that there are no audible alarms and that the audible alarms are not silenced Verify the nurse call polarity is set to normal default Connect the common lead of a digital multi meter to the pin 12
36. Extraction Pulse Oximeter Operator s Manual 4 23 E operation 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 Spo HIGH Sets the high scale of the SpO trend graph SCALE JeSpos LOW Sets the lower scale of the SpO trend graph SCALE PR HIGH SCALE Sets the high scale of the pulse rate trend graph BPM BH SCALE Sets the low scale of the pulse rate trend graph PI HIGH SCALE Sets the high scale of the PI trend graph PI LOW SCALE Sets the low scale of the PI trend graph Selects the default time scale of the trend view This setting only selects the time scale of the trend view when the trend data is initially displayed DEFAULT VIEW i e when the trend data is initially accessed The selections are 24 hrs 12 hrs 8 hrs 4 hrs 2 hrs 1 hr 30 minutes 10 minutes 1 minute and 20 seconds 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 ANALOG DUMP To send all the data that is stored in the trend memory to the analog TREND ACTION Output select the Analog Dump option Use this option to print the tre
37. Ey Simplified user interface 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 FIRST PAGE Press the Next Menu Page button to access the second page of NEXT MENU selections b PAGE Press and hold for 6 seconds to toggle between Traditional User Interface and the Simplified User Interface Enter password when prompted The Radical will retain this setting after a power cycle A amii Press the Alarm Menu Access button to enter the alarm settings menu Press the Sensitivity button to toggle between the Normal APOD and Maximum Sensitivity modes Use the Normal Sensitivity setting for typical monitoring purposes Use the APOD setting where there is a high probability of the sensor becoming detached Use the Maximum Sensitivity setting for patients with low perfusion or when the low perfusion message is displayed on the screen in APOD or normal sensitivity mode The default is APOD Note When using the Maximum Sensitivity setting the SENSOR O SENSITIVITY OFF detection performance may be compromised MAX Note In Custom mode see Section 4 Operation the unit will remain in Normal or APOD setting after a power cycle Maximum Sensitivity will automatically reset to Normal Sensitivity after a power cycle In Neo or Adult mode see Section 4 Operation the unit will reset the
38. H SOLVENTS TO CLEAN THE OXIMETER THESE SUBSTANCES ATTACK THE DEVICE S MATERIALS AND DEVICE FAILURE CAN RESULT Refer to Section 8 Cleaning and Reuse of Masimo Sensors for cleaning instructions of the sensor Radical Signal Extraction Pulse Oximeter Operator s Manual 9 1 d service and maintenance 9 2 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 Verify that the battery s are charging the battery charging LED indicators on the Docking Station flash prior to charging and remain illuminated while the battery s are charging A continuously flashing battery charging LED indicates that the internal battery temperature exceeds recommended operating conditions for proper battery charging Proper battery charging will proceed when the temperature returns to recommended operating conditions The Handheld battery requires approximately 2 to 3 hours for charging The optional Docking Station battery requires approximately 6 hours for charging When the battery charging LED indicators turn off addit
39. HE SERIAL PORT ON THE BACK PANEL UNLESS THE RADICAL IS CONNECTED TO THE AC MAINS POWER SUPPLY Radical Signal Extraction Pulse Oximeter Operator s Manual E operation Service 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 See Section 4 Password Operation on how to enter the password MENU ITEM DESCRIPTION HANDHELD BATTERY To deep discharge the Handheld battery select this menu item See DISCHARGE Section 9 Battery Operation and Maintenance for more information DS BATTERY To deep discharge the optional Docking Station battery select this DISCHARGE menu item See Section 9 Battery Operation and Maintenance for more information The discharge cycle will take approximately 16 hours to complete for the Handheld battery The Docking Station battery will take approximately 30 hours to complete A message will appear in the service screen when the discharge cycle is complete The batteries will be fully charged after completion of the cycle When deep discharge is started the backlight will automatically turn down to the default handheld battery powered level Wait until the message changes from In Progress to Done NOTE In order for the discharge cycle to be properly completed AC power must be supplied to the instrument throughout the cycle
40. 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 While in the SatShare mode if there are any significant discrepancies between the readings from the Radical and those on the monitor displaying the values obtained from SatShare the values reported by the Radical are to be considered the correct values To use the Radical with SatShare while it is not connected to AC power set the 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 Set the SatShare Numbers and the Interface Alarms parameters in the General menu according to Customer preference If displaying the simulated waveform is not desirable it is recommended to turn off the pleth waveform display of the multiparameter patient monitor Radical Signal Extraction Pulse Oximeter Operator s Manual a setup 3 6 CAUTIONS W SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING TO THE CALCULATED SATURATION AND PULSE RATE VALUES AND DO NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN PHYSIOLOGICAL WAVEFORMS THE MULTIPARAMETER PATIENT MONITOR DECODES THESE SIGNALS INTO SATURATION AND PULSE RATE V
41. Manual operation EF 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 SpO HIGH LIMIT The SpO 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 SpO LOW LIMIT The SpO low alarm limit can be set anywhere between 1 and 100 with a 1 step size NOTE The low alarm limit always has to be set below the high alarm setting When the high alarm limit is set below the low alarm limit the low alarm limit will automatically adjust to the next setting below the newly entered high alarm limit setting NOTE The SpO low limit can not be set below the password protected minimum low SpO alarm limit See Section 4 Operation Display for details PULSE RATE HIGH LIMIT BPM The pulse rate high alarm limit can be set anywhere between 30 BPM and 240 BPM with a 5 BPM step size PULSE RATE LOW LIMIT BPM The pulse rate low alarm limit can be set anywhere between 25 BPM and 235 BPM with a 5 BPM step size NOTE The low alarm limit always has to be set below the high alarm setting When the high alarm limit is set below the low alarm limit the low alarm limit will automatically adjust to the next
42. OR sensor being used Unit is searching for Disconnect and reconnect the sensor with patient s pulse the logos matching If values are not displayed within 30 i seconds disconnect and reconnect Unit is searching for sensor If pulse search continues remove PULSE SEARCH patient s pulse sensor and replace on a better perfused site r Disconnect and reconnect sensor SENSOR OFF Sensor off patient Reattach sensor Broken sensor cable wire Seon or inoperative LEDs or Pepjace sensor Refor n the instructions faulty detector g SERVICE Internal Failure Unit requires service REQUIRED 3 The SERVICE REQUIRED message fills the entire display Radical Signal Extraction Pulse Oximeter Operator s Manual troubleshooting e Troubleshooting The following chart describes what to do if the Radical system does not operate properly or fails PROBLEM POSSIBLE CAUSE S UNIT DOES NOT POWER One or both of the fuses ON have blown RECOMMENDATION Replace the fuses UNIT POWERS ON BUT The viewi THE GRAPHIC DISPLAY he viewing contrast is Use the Backlight Contrast button to adjust the viewing angle If the WHEN PRESSED Internal failure not correct condition persists the unit requires IS BLANK service Unit requires service Press the Alarm Silence button to silence the alarm If E IUOS SPEAKER Internal failure alarm continues to sound power down unit and remove Handheld battery if necessary BU
43. POTENTIALLY LEADING TO PATIENT HARM Mm DO NOT SOAK OR IMMERSE THE SENSOR IN ANY LIQUID SOLUTION UNLESS OTHERWISE SPECIFIED DO NOT STERILIZE ANY MASIMO SENSOR BY IRRADIATION STEAM OR ETHYLENE OXIDE Radical Signal Extraction Pulse Oximeter Operator s Manual sensors amp patient cables d Masimo SET patient cables Reusable patient cables of various lengths are available Only use appropriate Masimo oximetry patient cables for SpO measurements Other patient cables may cause improper Radical performance CLEANING AND REUSE OF MASIMO SET PATIENT CABLES Patient cables can be cleaned per the following procedure 1 Remove the cable from the sensor 2 Disconnect the cable from the monitor 3 Wipe clean with a 70 isopropyl alcohol pad 4 Allow the cable to dry before returning it to operation CAUTIONS M CAREFULLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY OF PATIENT ENTANGLEMENT OR STRANGULATION Wi DO NOT SOAK OR IMMERSE PATIENT CABLES IN ANY LIQUID SOLUTION DO NOT STERILIZE PATIENT CABLES BY IRRADIATION STEAM OR ETHYLENE OXIDE SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO PATIENT CABLES M DO NOT ATTEMPT TO REPROCESS RECONDITION OR RECYCLE ANY MASIMO PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS POTENTIALLY LEADING TO PATIENT HARMS Radical Signal Extraction Pulse Oximeter Operator s Manual 8 5 service and maintenance dn Introduction T
44. Pulse Oximeter Operator s Manual E operation Qutput operation l4 Output Ccon t MENU ITEMS DESCRIPTION Note The output menu selections are only available when the Radical Handheld is interfaced to the Docking Station Pleth MENU ITEMS DESCRIPTION Traces the plethysmographic waveform as shown on the Radical The following serial output modes are supported All serial output is RS display 232 based See the interface specifications in Section 7 Specifications Signal IQ ASCII 1 Traces the Signal IQ waveform as shown on the Radical display A full ASCII text data is sent to the serial interface at one second intervals The scale Signal IQ signal 100 is represented as 1 Volt while a zero ASCII text includes date and time stamp SpO pulse rate Pl and alarm Signal IQ signal 0 i ted as 0 Volt and exception values All text is single line followed by a line feed ANALOG OR ignal IQ signal 0 is represented as 0 Volt character and a carriage return ANALOG 2 OV Output ASCII 2 CONTINUED AQ Volt calibration signal is mapped to the analog output Use this ASCII text data is sent to the serial interface following a query from the signal for calibration of recording devices 0 Volts represents a connecting computer RadNet data output is in this format SERIAL saturation of 0 and a pulse rate of 0 bpm BINARY Compressed binary data is sent to the serial interface following a query 1V Output from the connect
45. ROOF W UNLESS OTHERWISE SPECIFIED DO NOT STERILIZE SENSORS OR PATIENT CABLES BY IRRADIATION STEAM AUTOCLAVE OR ETHYLENE OXIDE SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS W DO NOT ATTEMPT TO REPROCESS RECONDITION OR RECYCLE ANY MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS POTENTIALLY LEADING TO PATIENT HARM W ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS VERIFY THE COMPATIBILIY OF THE MONITOR CABLE AND SENSOR BEFORE USE OTHERWISE PATIENT INJURY CAN RESULT SELECTING A MASIMO SET SENSOR When selecting a sensor consider the patient s weight the adequacy of perfusion the available sensor sites and the duration of monitoring For more information refer to the following table or contact your Sales Representative Use only Masimo SET sensors and sensor cables Select an appropriate sensor apply it as directed and observe all warnings and cautions presented in the directions for use accompanying the sensor High ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight can interfere with the performance of an SpO sensor To prevent interference from ambient light ensure that the sensor is properly applied and cover the sensor site with opaque material if required Failure to take this precaution in high ambient
46. Rate LNOP Trauma Adult 30 kg 2 3 3bpm 5 bpm 2 3 bpm LNOPv ADHESIVE SENSORS LNOPv sensors must be used in conjunction with PC cables Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate LNOPv In 3 20 kg 276 3 3bpm 5bpm 2 3 bpm LNOPv Ne lt 3kg 3 3 3bpm 5bpm 3 3 bpm LNOPv Ad gt 30 kg 2 3 3bpm 5bpm 2 3 bpm LNOPv Ad L gt 30kg 2 3 3bpm 5bpm 2 3 bpm LNOPv Pd L 10 50 kg 2 3 3bpm 5bpm 2 3 bpm LNCS REUSABLE SENSORS LNCS sensors must be used in conjunction with LNC cables Weight Saturation Accuracy Pulse Rate Accuracy Low Perfusion Accuracy SENSOR Range No Motion Motion No Motion Motion Saturation Pulse Rate LNCS DCI gt 30 kg 2 3 3bpm 5bpm 2 3 bpm LNCS DCIP 10 50 kg 2 3 3bpm 5bpm 2 3 bpm LNCS TC I gt 30 kg x 3 5 N A 3 bpm N A x 3 596 x 3 bpm LNCS TF I gt 30 kg 2 N A 3 bpm N A 276 3 bpm Note The LNCS TF I and TC sensors were not validated under motion conditions Radical Signal Extraction Pulse Oximeter Operator s Manual 8 3 a sensors amp patient cables 8 4 LNCS ADHESIVE SENSORS LNCS sensors must be used in conjunction with LNC cables Weight Saturation Accuracy Pulse Rate
47. S RECOMMENDED THAT THE RADICAL HANDHELD IS DOCKED TO THE DOCKING STATION ATTACHED TO AN AC POWER SOURCE WHEN IT IS NOT IN USE TO ENSURE THAT THE BATTERY REMAINS FULLY CHARGED The following tables outline the estimated run times of the battery powered Radical 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 is always configured to include the Handheld battery It may optionally be configured to include the Docking Station battery Please determine the configuration of your system before referencing the following tables Configuration 1 Radical configured to only include the Handheld battery standard configuration the Docking Station battery is excluded NOTE For this configuration it is advisable to operate only the Radical Handheld unit when running on battery power Although it is possible to operate the entire Standalone unit the Handheld attached to the Docking Station with the Handheld battery powering the Docking Station as well on battery power the capacity of the Handheld battery pack is insufficient to support this mode for long periods of time The Power Save setting in the General menu determines whether the Docking Station is powered or not during battery operation See Section 4 General for a detailed description on proper use of the Power Save setting RADI
48. STAND Press hold the button for more than 2 seconds and then BY BUTTON release the button to turn the instrument off PERFUSION The Perfusion Index indicates numerically the percentage of INDEX pulsatile signal to non pulsatile signal pulse strength ary o P ee ii PULSE RATE e uee Rate Alarmi Limite Display Snows ine upper and 22 50 ALARM Limits Oe pulse rate alarm limits When an alarm limit is reachec or exceeded the pulse rate value and the violated limit DISPLAY flashes The Pulse Rate Measurement Display shows the patient s ee pulse rate in beats per minute The upper and lower pulse 23 89 PULSE RATE rate alarm limits are also displayed next to the pulse rate measurement The pulse rate is calculated and the display is updated at a frequency of once per second 2 4 Radical Signal Extraction Pulse Oximeter Operator s Manual Radical Signal Extraction Pulse Oximeter Operator s Manual 2 5 a System description 2 6 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 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 The following table outline w
49. TION TO THE RADNET CENTRAL MONITORING STATION THEREFORE WHEN BEING USED WITH THE RADNET INTERFACE MODULE THE HANDHELD LOCKING FEATURE SHOULD BE UTILIZED 3 8 Radical Signal Extraction Pulse Oximeter Operator s Manual operation EF Introduction To operate the Radical effectively the device must be set up properly and the operator must Wi Know how the pulse oximeter derives its readings see Section 1 Pulse Oximetry Wi Be familiar with its controls components and operation WI 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 Connect the patient cable to the Patient cable connector of the Radical Make sure it is a firm connection and the cable is not twisted sliced or frayed 3 Ensure that the power cord is plugged into the Power Entry Module of the oximeter and into the AC power 4 Select a sensor that is compatible with the oximeter before connecting it to the patient cable See section 8 Sensors and Patient Cables If using a single patient adhesive or disposable sensor check that the emitter red light and the photodetector are properly aligned Remove any substances that may interfere with the transmission of light between the sensor s light source and photodetector Attach the sensor to the patient Refer to the Directions for Use of the sensor
50. TTONS DON T WORK Unit requires service The following chart describes what to do when encountering common problems PROBLEM POSSIBLE CAUSE S HANDHELD BATTERY DOES NOT CHARGE AC power cable may be disconnected RECOMMENDATION Restore power to the device PRINT FUNCTION DOES Wrong serial cable is NOT WORK used Make sure a null modem cable is used LED LIGHTS ON LEFT Incompatable version of SIDE OF DOCKING software on Radical STATION handheld and docking CONTINUOUSLY FLASH Station Upgrade to current software versions Match handheld to docking station with compatable software versions BATTERY RUN TIME IS SIGNIFICANTLY REDUCED Memory effects Use Battery Discharge function as described in Section 4 Service NOTE When a version R4 or later handheld is connected to a prior version docking station R2 2 or earler the handheld component will continue to accurately monitor SpO and pulse rate however certain Radical features normally accessed through the docking station including SatShare analog output and serial output will not be available to the user Radical Signal Extraction Pulse Oximeter Operator s Manual specifications ia Radical specifications PERFORMANCE measurement range SpO 1 100 Pulse Rate 25 240 beats per minute bpm Perfusion 0 02
51. an arterial pulsation Even with a plethysmographic waveform obscured by artifact the Radical locates the arterial pulsation The pulse tone when enabled coincides with the vertical line of the Signal IQ The height of the vertical line of the Signal IQ indicates the quality of the measured signal A high vertical bar indicates that the SpO measurement is based on a good quality signal A small vertical bar indicates that the SpO measurement is based on data with low signal quality When the signal quality is very low the accuracy of the SpO measurement may be compromised and a Low Signal IQ message is displayed in the message area on the Radical display When the Low Signal IQ message appears proceed with caution and do the following Wi Assess the patient Wi Check the sensor and ensure proper sensor application The sensor must be well secured to the site for the Radical to maintain accurate readings Also misalignment of the sensor s emitter and detector can result in smaller signals WI Determine if an extreme change in the patient s physiology and blood flow at the monitoring site occurred e g an inflated blood pressure cuff a squeezing motion sampling of an arterial blood specimen from the hand containing the pulse oximetry sensor severe hypotension peripheral vasoconstriction in response to hypothermia medications or a spell of Raynaud s syndrome Wi With neonates or infants check that the peripheral blood flow to th
52. at change usual blood pigmentation may cause erroneous readings Severe anemia may cause erroneous SpO readings Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging MRI scanning Induced current could potentially cause burns The pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements If using pulse oximetry during full body irradiation keep the sensor out of the irradiation field If the sensor is exposed to the irradiation the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period For home use ensure that the pulse oximeter s alarm can be heard from other rooms in the house especially when noisy appliances such as vacuum cleaners dishwashers clothes dryers televisions or radios are being operating Always remove the sensor from the patient and completely disconnect the patient from the pulse oximeter before bathing the patient Do not place the pulse oximeter where the controls can be changed by the patient Do not place the pulse oximeter face against a surface This will cause the alarm to be muffled Do not place the pulse oximeter on electrical equipment that may affect the pulse oximeter preventing it from working properly Do not expose the pulse oximeter to excessive moisture such as direct exposure to rain Excessive moisture can cause the pulse oximeter to perform inaccurately or fa
53. c signal and sends it to the Radical for calculation rd ir 4 LED s Recessed Photo Detector Once the Radical receives the signal from the sensor it utilizes Masimo SET signal extraction technology for calculation of the patient s functional oxygen saturation and pulse rate Radical Signal Extraction Pulse Oximeter Operator s Manual Overview KI FUNCTIONAL SATURATION The Radical is calibrated to measure and display functional saturation SpO the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen MEASURED VS CALCULATED SATURATION Oxygen measurements that can be obtained from the Radical are commonly compared to invasive measurements obtained from blood gas samples When comparing invasive and noninvasive measurements and interpreting values caution should be used as the calculated values obtained from the blood gas sample may differ from the SpO measurements of the pulse oximeter Different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen PO2 and saturation such as pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin As blood gas samples are usually taken over a period of 20 seconds the time it takes to draw the blood a meaningful comparison can only be a
54. chieved if the core oxygen saturation of the patient is stable and not changing over the period of time that the blood gas sample is taken MASIMO SET SIGNAL EXTRACTION TECHNOLOGY Masimo Signal Extraction Technology s signal processing differs from conventional pulse oximeters Conventional pulse oximeters assume that arterial blood is the only blood moving pulsating in the measurement site During patient motion however the non arterial blood also moves which causes conventional pulse oximeters to read low values because they cannot distinguish between the arterial and venous blood movement sometimes referred to as noise Masimo SET pulse oximetry utilizes parallel engines and 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 The Masimo SET signal processing algorithm Discrete Saturation Transform DsT 8 reliably identifies the noise isolates it and using adaptive filters cancels it It then reports the true arterial oxygen saturation for display on the monitor Radical Signal Extraction Pulse Oximeter Operator s Manual HW Overview Masimo SET Parallel Engines MEAS R IR Conventional CONF Pulse Oximetry Post Processor Adaptive MEAS Filter with CONF DST Digitized MEAS Confidence Filtered amp SST CONF Based Normalized
55. e accessory mount for the pole clamp accessory and access to the Handheld battery pack pulsating bar The Pulse Waveform Display shows the acquired PULSE plethysmograph waveform The pleth waveform is scaled with a8 M WAVEFORM signal strength Signal strength is defined as the relation of DISPLAY arterial pulsatile signal to the non pulsatile signal component The Time and Date Indicator displays the current time and AN gags TIME AND DATE date The time is displayed in 12 or 24 hour format The date 16 NEUES INDICATOR is displayed in dd mm yy or mm dd yy format Select the date and time display formats in the Clock menu Press the Backlight Button to change the illumination level of the backlight With the AC line power connected four levels be a nite e ao in po i m n illumination evel In the Handheld mode three levels of illumination are a BACKLIGHT available again in addition to the no illumination level Use CONTRAST the lowest illumination for most efficient battery usage The BUTTON backlight Button is also used to change the contrast of the LCD display Press and hold the Backlight Button for longer than six seconds to change the contrast Release the Backlight Button at the desired contrast setting Press the Alarm Silence Button to temporarily silence patient F DOCKING and low battery alarms Press the Alarm Silence Button a STATION mie a Hand
56. e Alarm Silence mute setting in the Alarms menu Alarm messages Alarm messages indicate a problem or condition which may affect accurate monitoring values Do not ignore these messages Correct any fault before continuing Press the Alarm Silence key to temporarily silence the audible alarm Alarm messages and violating values flash on the display and the Docking Station front panel alarm indicator flashes red if the Handheld unit is in the Docking Station If the measurement returns to within limits the alarm turns off A list of alarm conditions that cause audible and visual alarm indications and the displayed alarm messages are shown in the following table The reason of why these alarms might occur is also shown MESSAGE DESCRIPTION SENSOR OFF The sensor is not properly attached to the patient NO SENSOR The sensor is not properly attached to the monitor SpO HIGH The high SpO rate limit has been exceeded Sp0 LOW The low SpOz rate limit has been exceeded PR HIGH The high pulse rate limit has been exceeded PR LOW The low pulse rate limit has been exceeded Radical Signal Extraction Pulse Oximeter Operator s Manual B alarms messages MESSAGE POSSIBLE CAUSE S RECOMMENDATION Sensor not fully inserted May be an incorrect sensor or a defective into the connector sensor or cable Insert sensor into connector Disconnect and reconnect sensor Refer to the instructions for the NO SENS
57. e operating in the Power Save mode a power cycle of the Radical may be required to activate the Docking Station again after it has been disabled Clock MENU ITEMS DESCRIPTION TIME Set the time hour minutes and seconds in 24 hour format Set the format of the time display as it will be shown on the front panel TIME FORMAT Available options are 12 hour default and 24 hour display DATE Set the date day month and year Set the format of the date display as it will be shown on the front panel DATE FORMAT Available options are mm dd yy default and dd mm yy About This displays the copyright and software versions of the Handheld and Docking Station Config MENU ITEMS DESCRIPTION The Rapid Desat Limit will ignore the Alarm Delay setting if desaturation falls below the Low SpO alarm threshold per a user defined percentage Audible tones are generated immediately along with all visual indicators The Rapid Desat Limit can be set to the following RAPID DESAT OFF The Alarm Delay setting will delay audible alarm tones regardless LIMIT of how deep the desaturation is below the alarm threshold 5 The Alarm Delay setting is ignored if the desaturation is 5 meaning 5 saturation units below the Low SpO alarm threshold 10 The Alarm Delay setting is ignored if the desaturation is 1096 meaning 10 saturation units below the Low SpO alarm threshold Radical Signal Extraction
58. e sensor site is not interrupted Interruption for example may occur while lifting or crossing their legs during a diaper change After performing the above if the Low Signal IQ message is displayed frequently or continuously obtaining an arterial blood specimen for CO Oximetry analysis may be considered to verify the oxygen saturation value Radical Signal Extraction Pulse Oximeter Operator s Manual 4 5 B LOW PERFUSION The Radical displays a 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 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 This may occur even with a pulse rate that correlates with the ECG heart rate CAUTION IF THE LOW PERFUSION MESSAGE IS FREQUENTLY DISPLAYED FIND A BETTER PERFUSED MONITORING SITE INTHE INTERIM ASSESS THE PATIENT AND IF INDICATED VERIFY OXYGENATION STATUS THROUGH OTHER MEANS 1 Severinghaus JW Spellman MJ Pulse Oximeter Failure Thresholds in Hypotension and Vasoconstriction Anesthesiology 1990 73 532 537 ACTIONS TO BE TAKEN If the SpO readings show significant differences do the following M Make sure the emitter and photodetector are align
59. e signal to the non pulsatile signal component NUMBERS Shows the SpO and pulse rate numbers and the signal IQ in the form of a pulse bar on 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 VIEW Allows the user to select and view the Trend Display between SpO and TREND pulse rate SpO BPM perfusion index and pulse rate PI BPM or SpO and perfusion index SpO PI Allows the user to set the contrast of the LCD display Contrast ranges from 0 to 63 NOTE The contrast can also be set by pressing and holding the Backlight Contrast Button on the front panel CONTRAST LANGUAGE Allows the user to select the language displayed on the screen Allows the user to select user mode or reset the settings to factory defaults NOTE A password is required to access these menu options SAVE LAST This allows the user to either use Custom setting or Adult Neonatal settings Select Yes to use custom settings SAVE AS ADULT DEFAULT Store current settings as Adult default setting SAVE AS NEO Store current settings as Neonatal default setting RESTORE FACTORY Recall factory setting for Custom Adult and Neonatal LOW SpO LIMIT Allows the user to set a custom default minimum low SpO limit The unit will return to this setting after a pow
60. ece cob OEC deed CY POE 2 6 Standalone Front Panel 5 ice E RR Gd Radices kh ius 2 7 Standalone Back Panel ort ever dee XR eee 2 8 SyImbolSu Ss Sed ee eee be ss wet s idus catt a one ae 2 9 Radical monitor interface 2 10 SECTION 3 SETUP IntrodUGtior 3x eaae aide ort dor eeistu t ES e ter B IU te ROSE ERR E 3 1 Unpacking and inspection 0 0 0 0 ieee cece teen n eens 3 1 Preparation for monitoring sentensia cinite iaa eee 3 1 Radical power requirements 3 1 Initial battery Charging 2 5 we ene neni thee neus 3 2 Initial installation 25 5 oed ER dren Eb SNP RARE 3 2 Factory Default Settings 0 cece eects 3 3 Custom user Defined Settings 0 cece eee eee eee 3 3 Adult neo hospital defined settings 0 cece eee eee eee eee 3 4 SatShare Setup ener sc eer pre we ux wares dees eden 3 5 Philips Vuelink set p 4 2 sse erect ve RR ET ede aed BIER RE DES 3 6 Spacelabs universal flexport setup isses 3 7 RadNet Set p Ss seg o oeste deser iere idedese s Een ig dad 3 7 SECTION 4 OPERATION Introduction Lua peters Reb ur RAE EVUREEMMEXRPER RU OI pibe Cei Oud 4 1 Basic Operation conto ttp oec v rule vivet dd e per eo den 4 1 General Setup and Use 0 ccc cece cnet eh 4 1 Successful SpO monitoring 2 eee eens 4 3 Masimo Sensors 1 3 ise pe eet R4 RR s ER E on anor aaah ees 4 3 Numeric Display SpOs essere hes D ee et 44 Numeric Display Pulse Rate sssssss
61. ecks HANDHELD FRONT PANEL The following figure and corresponding text outline all the features of the Handheld Radical Pleth Signal IQ View Li LIT Itt tt P P1412 wen 06 10 23pm 0327 03 Numbers View mt s h rama 03127103 Radical Signal Extraction Pulse Oximeter Operator s Manual system de scription Ito HAND m Press down the Handheld Release Button and pull the Handheld BUTTON device off the Docking Station The functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO The upper and lower SpO alarm SpO limits are also displayed next to the SpOo measurement When a a pU sensor is not connected to a patient and during pulse search the 2j 98 MEASUREMENT display will show dashed lines When the measured value is DISPLAY outside of the alarm limits the SpOo Measurement Display flashes and an alarm will sound The oxygen saturation is calculated and the display is updated at a frequency of once per second The Masimo SET symbol is shown on the Radical display when 8 Masimo SET processing is active SET MASIMO SET Note Patient information not Masimo SET will be displayed when using a RadNet compatible unit connected to a RadNet central station A The FastSat symbol is shown
62. ects signal data from the patient and sends it to the instrument The instrument displays the calculated data in three ways 1 Asa percent value for arterial oxygen saturation SpO 2 Asa pulse rate PR 3 Asa plethysmographic waveform The following figure shows the general monitoring setup 1 Instrument 2 Patient Cable 3 Sensor PRINCIPLE OF OPERATION Pulse oximetry is governed by the following principles 1 Oxyhemoglobin oxygenated blood and deoxyhemoglobin non oxygenated blood differ in their absorption of red and infrared light spectrophotometry 2 The amount of arterial blood in tissue changes with your pulse photoplethysography Therefore the amount of light absorbed by the varying quantities of arterial blood changes as well The Radical Pulse Oximeter uses a two wavelength pulsatile system to distinguishbetween oxygenated and deoxygenated blood Signal data is obtained by passing red rd 660 nm wavelength and infrared ir 905 nm wavelength light through a vascular bed for example a fingertip a hand a foot and measuring changes in light absorption during the pulsatile cycle This information may be useful to clinicians The radiant power of the light is rated at 0 79mW max 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 The photodetector receives the light converts it into an electroni
63. ed directly opposite each other Wi Selecta site where the distance between the emitter and photodetector is minimized Wi Wipe the sensor site with a 70 isopropyl alcohol pad or rubefacient cream 10 30 methyl salicylate and 2 10 menthol for 20 30 seconds Strong vasodilator creams such as nitroglycerin paste are not recommended Wi f possible remove electrical noise sources such as electrosurgical units or other electricalelectronic equipment If these solutions are not possible operate the oximeter on battery power or try plugging the oximeter into a different electrical outlet if artificial nails or excessive fingernail polish are present select another site or remove the polish artificial nails Wi f possible ensure that the sensor is placed in a location with low ambient light Although the Radical with integrated Masimo SET technology has significant immunity to ambient light excessive ambient light may cause readings to be incorrect CAUTION IF ANY MEASUREMENT SEEMS QUESTIONABLE FIRST CHECK THE PATIENT S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE PULSE OXIMETER FOR PROPER FUNCTIONING Radical Signal Extraction Pulse Oximeter Operator s Manual ee SENSITIVITY The Radical is equipped with 3 different sensitivity modes Each mode allows the Clinician to change the sensitivity settings of the device to meet the increased demands of the patient s physiological condition or enable it to work during periods of low
64. ent off and on the user is encouraged to try to correct the interference by one or more of the following measures I Reorient or relocate the receiving device M Increase the separation between the equipment M Connect the equipment into an outlet on a circuit different from that to which the other device s are connected M Consult the manufacturer for help A functional tester cannot be utilized to assess the accuracy of the Pulse Oximeter or any sensors Radical Signal Extraction Pulse Oximeter Operator s Manual table of contents SECTION 1 OVERVIEW About this Manual 5 rroERERII eer PRU t E EUIS PEERS 1 1 Product description assure vtov NE pex d GA Pee ce vex 1 3 Features and benefits 1 3 Indicatioris for Use ossia eo mene ate ete RAI UC VR 1 8 Pulse OXIME e ees eet RP ERR EX aii da prone Ra S us 1 4 General Description 0 cece cece eee e tenet nent neee 1 4 Principle of Operation 0 0 0 ccc cece cece ete eee nen teen aes 1 4 Functional saturation gt ce iocis Adrani niid tob pirau 1 5 Measured vs Calculated Saturation 2 0 0 0 ccc cece eee eee 1 5 Masimo SET signal extraction technology 0 0 cece cence eee 1 5 SECTION 2 SYSTEM DESCRIPTION Introduction iaoiai ette fen ety the edd daddy dvs det Saori UA ded 2 1 Handheld Front Panel 00 eee e eect eee eens 2 2 Handheld back Panel sssssssssssss n eet nenenes 2 5 Radical standalone sic 3 apddycaa pr ica E r
65. ent readings Wi Press the Alarm Silence button B6 The alarm tone ceases for the displayed amount of time To begin patient monitoring B6 Adjustthe alarm limits Wi Adjust the alarm volumes B6 Adjust the pulse beep volume Verify the sensor is on correctly and that the measured data is appropriate see Section 4 Successful SpO Monitoring Monitor the patient 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 Press and hold the Power Standby Button for 2 seconds to turn the oximeter off Radical Signal Extraction Pulse Oximeter Operator s Manual operation EF Successful SpOg2 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 Read the sensor Directions for Use for proper sensor application MASIMO SENSORS Before use carefully read the pertinent sensor Directions for Use Use only Masimo oximetry sensors for SpO measurements Tissue damage can be caused by incorrect application or use of a sensor for exa
66. er cycle Radical Signal Extraction Pulse Oximeter Operator s Manual operation EF General MENU ITEMS DESCRIPTION The signal averaging time of this device can be set to 2 4 8 10 12 14 and 16 seconds AVERAGINGTIME 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 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 HOME USE or deactive this mode See Section 4 Home Mode Operation for a detailed description INTERFACE During SatShare HP Vuelink Spacelabs Flexport and RadNet operation ALARMS the audible alarms can be enabled or disabled SATSHARE During SatShare operation the saturation and pulse rate measurements NUMBERS can be displayed on the Radical by selecting a SatShare Numbers setting of Yes Select Yes to maximize battery operating time of the Radical while powered by the Handheld battery or optional Docking Station battery Selecting Yes will disable Docking Station functions such as SatShare POWER SAVE Serial and Analog output Selecting No will activate these Docking Station functions while operating on battery power Whil
67. ftware including the related documentation on behalf of any part of the United State Government the following provisions apply the software is deemed to be commercial software and commercial computer software documentation respectively pursuant to DFAR Section 227 7202 FAR 12 212 as applicable Any use modification reproduction release performance display or disclosure of the software including the related documentation by the U S Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this agreement Radical Signal Extraction Pulse Oximeter Operator s Manual accessories Accessories The following accessories and re order parts are available with the Radical Signal Extraction pulse oximeter PART NUMBER ACCESSORIES 1315 REPLACEMENT BATTERY RADICAL HANDHELD 1317 RADICAL POLE CLAMP 1395 RADICAL HANDHELD LOCK 1584 RADICAL POWER CORD LOCK 5 PACK 1595 SATSHARE CABLE ATO1 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 SATSHARE CABLE DS02 1528 SATSHARE CABLE DS03 1357 SATSHARE CABLE HP03 1321 SATSHARE CABLE MQ01 1789 SATSHARE CABLE MS
68. held interfaces with the Docking Station when the SENSOR OFF or NO SENSOR messages are CONNECTOR MOugh this connector flashing i e the sensor is removed from the patient to oe ALARM acknowledge the end of monitoring In these states all c POLECLAMP The optional Pole Clamp accessory attaches to this holder we SILENCE further alarms are piis until the pulse oximeter starts 2 12 ACCESSORY See the Directions for Use of the Pole Clamp accessories for BUTTON measuring SpO ancipusg rate again A HOLDER attachment instructions Note System failure alarms can be silenced by pressing the Power Standby or Alarm Silence Button If the Power Standby E The Radical Handheld is ey powered by a NiMH battery located rel ae not silence the system fault alarm press the Alarm 8 BATTERY PACK in this compartment For battery care and replacement VENCO PUHON __ please see Section 9 Replacing the Batteries The Output Mode Indicator displays the output mode HPO1 selected by the user Philips Vuelink or Spacelabs Flexport The Output Mode Indicator also displays the type of OUTPUT MODE SatShare cable The Output Mode Indicator is only INDICATOR displayed when the Radical device actively outputs data Philips Vuelink other than ASCII text or interfaces with a monitor through the SatShare cable The Output Mode Indicator will take place of the Time and Date indicator when utilized Press the Power Standby Button to turn the instrument on POWER
69. het ey LO EEEa cei cH WU PERO 9 9 Repair Poliyen erani bh does dx hp RR RET E ENDE EE OR RR etd 9 9 ReturriProcedute eoe srurepr Rr yk RUE I ineo aaa MEER 9 9 EXCIUSIOTIS x exis pra aie REPETI NU wee Sane A BEd tona UR da ads 9 10 End user license agreement ns toeten puc ppt Ren US ETUDES 9 10 SECTION 10 ACCESSORIES ACCOSSOTI S deste ev e xs E Sued pipi ssl ae d 10 1 Radical Signal Extraction Pulse Oximeter Operator s Manual Overview HW About this Manual This manual explains how to set up and use the Masimo SET Radical Pulse Oximeter herein known as the Radical Important safety information relating to general use of the Radical 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 In addition to the safety section this manual includes the following sections SECTION 1 OVERVIEW gives a general description of pulse oximetry SECTION 2 SYSTEM DESCRIPTION describes the Radical system and its functions and features SECTION 3 SETUP describes how to setup the Radical for use SECTION 4 OPERATION describes the operation of the Radical Pulse Oximetry system SECTION 5 ALARMS AND MESSAGES describes the alarm system messages SECTION 6 TROUBLESHOOTING describes troubleshooting information SECTION 7 SPECIFICATIONS gives the detailed specifications of the Radical Pulse Ox
70. hich features are available for each model of Docking Station DOCKING STATION FEATURES ROS RDS 1B Ld ADS Ll RDS 4 AC Power Input m SatShare Interface a n Serial RS 232 Interface L Bm Nurse Call Analog Output Interface m m 12 hour Extended Battery uH L Automatic Display Rotation Support Gravity Detector m m Docki tation Batt ocking Station Battery u m Charging Indicator Handheld Battery Charging Indicator Red Alarm Indicator AC Power Indicator L Docking Indicator Handheld Battery Deep Discharge Support m a a Docking Station Battery Deep Discharge Support m m a a The RDS 1 and RDS 3 are optionally available with RadNet capability Refer to Section 3 RadNet Setup for details Radical Signal Extraction Pulse Oximeter Operator s Manual system description pe STANDALONE FRONT PANEL The following figure and corresponding text review the features of the Radical Standalone device 11 42 48 03 2703 DOCKING The Docking Station Battery Charging Indicator is illuminated P STATION when the Docking Station battery is charging The indicator O BATTERY blinks just prior to charging The charging indicator does not i CHARGING illuminate when the battery is fully charged or when the battery INDICATOR is not present HANDHELD The Handheld Bat
71. his section covers How to test the operation of the Radical and the SatShare interface How to properly clean the Radical How to recharge and replace the batteries How to replace the fuses 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 Safety checks should be performed at regular intervals or in accordance with local and governmental regulations WARNING ELECTRICAL SHOCK AND FLAMMABILITY HAZARD BEFORE CLEANING THE OXIMETER ALWAYS TURN IT OFF AND DISCONNECT THE POWER CORD FROM THE AC POWER SUPPLY Cleaning To clean the display panel use a cotton swab moistened with 70 isopropyl alcohol and gently wipe the panel To clean the outer surface of the oximeter use a soft cloth dampened with a mild soap and water Do not allow liquids to enter the interior of the instrument CAUTIONS W DO NOT AUTOCLAVE PRESSURE STERILIZE OR GAS STERILIZE THIS OXIMETER W DO NOT SOAK OR IMMERSE THE MONITOR IN ANY LIQUID W USE THE CLEANING SOLUTION SPARINGLY EXCESSIVE SOLUTION CAN FLOW INTO THE MONITOR AND CAUSE DAMAGE TO INTERNAL COMPONENTS W DO NOT TOUCH PRESS OR RUB THE DISPLAY PANELS WITH ABRASIVE CLEANING COMPOUNDS INSTRUMENTS BRUSHES ROUGH SURFACE MATERIALS OR BRING THEM INTO CONTACT WITH ANYTHING THAT COULD SCRATCH THE PANEL W DO NOT USE PETROLEUM BASED OR ACETONE SOLUTIONS OR OTHER HARS
72. iation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population 3 The Radical with SatShare has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo s simulator with signal strengths of greater than 0 02 and a transmission of greater than 5 for saturations ranging from 70 to 100 This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population 4 This represents approximate run time with backlight at minimum and Power Save mode using a new fully charged battery 5 If the batteries are to be stored for extended periods of time it is recommended that they be stored between 20 C to 30 C and at a relative humidity less than 85 If stored for a prolonged period at environmental conditions beyond these limits overall battery capacity may be diminished and lifetime of the batteries may be shortened 6 With FastSat the averaging time is dependent on the input signal For the 2 and 4 second settings the averaging time may range from 2 4 and 4 6 seconds respectively 7 Maximum sensitivity mode fixes perfusion limit to 0 02 Serial interface specifications The digital interface for serial communication is based on the standard RS 232 protocol The Radical by default always outputs ASCII1 text data through the serial port unless the user selects a different out
73. ify that the Radical acknowledges each key press with an audible beep tone or by indicating a change on the display Alarm Limit Test 1 B1 0 oO PO With the monitor turned on select the Menu Access key and enter the Alarm menu Change the High Saturation Alarm parameter to a value two points below the currently selected value and accept the change Verify that the newly set parameter is shown on the Saturation Alarm Limit Display next to the SpO or pulse rate measurement display Return the High Saturation Alarm parameter to its original setting Repeat steps 1 to 3 with the Low Saturation Alarm parameter Repeat steps 1 to 3 with the High Pulse Rate Alarm parameter Repeat steps 1 to 3 with the Low Pulse Rate Alarm parameter Reset the alarm limits again to the original settings Display Contrast Test 1 With the monitor turned on select the Menu Access key and enter the Display menu Change the Contrast parameter by scrolling through the contrast settings Return the Contrast setting to the original value or a value that allows maximum viewing contrast Exit the Menu system and press and hold down the Backlight Contrast button for several seconds The display will scroll again through all the contrast settings Release the Backlight Contrast button again when the display shows maximum viewing contrast Radical Signal Extraction Pulse Oximeter Operator s Manual service and maintenance dn Testing with Masimo S
74. il Radical Signal Extraction Pulse Oximeter Operator s Manual SAFETY INFORMATION WARNINGS CAUTIONS AND NOTES CONTINUED Do not place containers containing liquids on or near the pulse oximeter Liquids spilled on the pulse oximeter may cause it to perform inaccurately or fail Failure of Operation If the pulse oximeter fails any part of the setup procedures or leakage tests remove the pulse oximeter from operation until qualified service personnel have corrected the situation Patient Safety If a sensor is damaged in any way discontinue use immediately Disposal of product Comply with local laws in the disposal of the unit and or its accessories The Pulse Oximeter Module can be used during defibrillation but the readings may be inaccurate for up to 20 seconds This equipment has been tested and found to comply with the limits for medical devices to the EN 60601 1 2 2002 Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to other devices which can be determined by turning the equipm
75. ime to 8 seconds during SatShare operation Averaging times of 2 4 or 8 seconds remain unchanged during SatShare operation When the Radical returns to non SatShare operation the Radical will maintain the averaging time setting used in the SatShare mode Wi When the Radical starts to operate in the SatShare mode the sensitivity mode is set to Normal sensitivity The sensitivity mode can manually be set to Maximum or APOD sensitivity Wi While operating in the SatShare mode the Radical may automatically disable the SatShare interface if the perfusion index drops below 0 1 while the sensitivity is set to Max sensitivity To enable the SatShare interface again set the Radical to the Normal or APOD sensitivity mode increase the perfusion at the measurement site by warming the patient or sensor site or move the sensor to a site with better perfusion Radical Signal Extraction Pulse Oximeter Operator s Manual operation l4 CAUTIONS W SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING TO THE CALCULATED SATURATION AND PULSE RATE VALUES AND DO NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN PHYSIOLOGICAL WAVEFORMS THE MULTIPARAMETER PATIENT MONITOR DECODES THESE SIGNALS INTO SATURATION AND PULSE RATE VALUES W DURING SATSHARE OPERATION THE AUDIBLE ALARMS MAY BE MUTED ON RADICAL WHEN THE AUDIBLE ALARM IS MUTED INDICATED BY BELL WITH SLASH THROUGH IT ON RADICAL USE THE MULTIPARAMETER MONITOR FOR AUDIBLE ALARM INDICATION M
76. imeter SECTION 8 SENSORS AND PATIENT CABLES outlines how to use and care for Masimo SET sensors and Masimo SET patient cables SECTION 9 SERVICE AND MAINTENANCE describes how to maintain service and obtain repair for the Radical Pulse Oximeter SECTION 10 ACCESSORIES lists the available Radical accessories Radical Signal Extraction Pulse Oximeter Operator s Manual 1 1 Bg 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 A CAUTION is given when any special care is to be exercised by the patient or user to avoid injury to the patient damage to this device or damage to other property 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 Overview HW Product description The Radical Pulse Oximeter is a noninvasive arterial oxygen saturation and pulse rate monitor The Radical can be used as either a Handheld or a Standalone monitor The Radical features a backlit Liq
77. ing computer A 1 Volt calibration signal is mapped to the analog output Use this PHILIPS VUELINK signal for calibration of recording devices 1 Volt represents a SpO pulse rate and plethysmographic waveform data are sent in saturation of 10096 and a pulse rate of 250 bpm Philips VueLink format to the serial port Alas PACELABS FLEXPORT i SPAC 9 The nurse call output will be activated based on alarm events SpO pulse rate and plethysmographic waveform data are sent in Spacelabs Flexport format to the serial port Low Signal IQ NURSE CALL The nurse call output will be activated based on Low Signal IQ events SpO 0 100 Scales the saturation measurement with 0 being equal to 0 Volt and Alarm amp Signal IQ 100 equal to 1 Volt The nurse call output will be activated based on alarm and Low Signal ANALOG OR p Vies IQ events cales the saturation measurement with 5096 being equal to 0 Volt an ANALOGS 100 equal to 1 Volt Normal PULSE RATE Standard polarity See section 7 Analog output nurse call Scales the pulse rate measurement with 0 BPM being equal to 0 Volt specifications and 250 BPM equal to 1 Volt POLARITY Invert 4 18 Radical Signal Extraction Pulse Oximeter Operator s Manual This setting reverses the Normally Open and Normally closed contacts See section 7 Analog output nurse call specifications CAUTION TO AVOID EXCESSIVE BATTERY DISCHARGING DO NOT CONNECT ANY EQUIPMENT TO T
78. ing the AC power 2 Verify that the green Handheld Battery Indicator LED is lit up When the Radical is fully charged the green Handheld Battery Indicator turns off Turn the Radical on and verify that the Battery indicator shows a full charge 9 8 Radical Signal Extraction Pulse Oximeter Operator s Manual service and maintenance dn Service and 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 Please clean contaminated and or dirty equipment before returning following the cleaning procedure described in 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 Call Masimo at 800 326 4890 and ask for Technical Support Ask for an RMA number Package the equipment securely in the original shipping container if possible and enclose or include the following information and items Wi Aletter describing in detail any difficu
79. inutes of battery life is left and the 4 battery needs to be recharged The Docking Station Battery imi INDICATORS Status indicator is not shown when the optional Docking Station battery is not present TOUCH KEY Press a Touch Key Control Button to select the corresponding touch key 40 e CONTROL icon See Section 4 Touch Key Control Buttons and Icons for more E BUTTONS details NN The speaker indicates audio alarms Care should be taken not to KD I SPEAKER cover the speaker and muffle the audible alarm volume Connect the patient cable to the Handheld Radical by plugging x PATIENT CABLE the cable into the Patient Cable Connector Use only Masimo 42 ASH CONNECTOR compatible sensors and cables with this oximeter See Section 8 Sensors and Patient Cables for more details 5E TOUCH KEY The Touch Key Icons indicate the software menu items that can a3 GO ICONS be selected through the Touch Key Control Buttons Pressing a Touch Key Control Button next to an icon selects the option Radical Signal Extraction Pulse Oximeter Operator s Manual a System description System description pe The Signal IQ shows the acquired signal quality and the HANDHELD BACK PANEL if timing of the pulse A tall vertical line indicates a high quality The Handheld back panel features the interconnection to the Docking Station an a9 M9 gignatia signal while a small vertical line indicates a low quality signal The Signal IQ may also be shown as a singl
80. ional trickle charging may occur to complete charging Although battery charging can occur while the Handheld is docked and powered on most efficient charge times are achieved with the Handheld unit turned off CAUTIONS W ALLBATTERIES LOSE CAPACITY WITH AGE THUS THE AMOUNT OF RUN TIME LEFT AT LOW BATTERY WILL VARY DEPENDING UPON THE AGE OF THE BATTERY W AT LOW BATTERY CONNECT THE RADICAL TO AC POWER TO PREVENT LOSS OF POWER During battery operation of the Radical please note that the following operating conditions affect the estimated run time of the included batteries Wi illumination of the backlit LCD screen To conserve battery power keep the backlit LCD screen at minimum illumination Wi Volume of the alarm tones To conserve battery power keep the frequency of the audible alarms to a minimum and at minimum volume Wi The SatShare feature To conserve battery power always keep the unit on AC line power Memory effects of the battery pack may shorten run time When battery run time is significantly reduced it is advisable to completely discharge and fully recharge the battery pack To properly discharge the battery pack use the Battery Discharge function as described in Section 4 Service Radical Signal Extraction Pulse Oximeter Operator s Manual service and maintenance dn CAUTION MIF THE RADICAL HANDHELD HAS NOT BEEN USED OR CHARGED WITHIN SEVEN 7 DAYS OR MORE THEN RECHARGE THE BATTERY PRIOR TO USE MIT I
81. is storing all 3 parameters in trend memory but can only disply 2 parameters at any one time The Trend Display can be adjusted to the desired parameter by Selecting Trend from the Main Display Menu Radical Signal Extraction Pulse Oximeter Operator s Manual 4 21 n operation 4 22 Apis Trend U3Z70 114246 A Sp0 90 97 99 BPM 60 70 80 f The top line on the trend display shows the time scale of the trend graph followed QD by the starting date starting time and end time of the data set that is displayed on the screen The second line of the display shows the minimum average and maximum SpO 2 Plor pulse rate measurements contained in the displayed data set excluding zero measurements The vertical scale of the SpO PI or pulse rate graphs can be set in the Trend Setup menu A dark line on the trend graph indicates the averaged data while grayed out data CHIMIE ne points show minimum and maximum values A grayed out box or line located on the bottom axis of the saturation graph indicates a period of time for which the Low Signal IQ indicator was active indicating the signal quality was very low and the accuracy of the measurement may have been compromised The available trend graphs show two of the desired trend parameter measurements G displayed versus time By default the trend dis
82. ith other software or other written materials is expressly forbidden You may be held legally responsible for any copyright infringement that is cause or incurred by your failure to abide by the terms of this license Nothing in this license provides any rights beyond those provided by 17 U S C 8117 5 Use Restriction As the Purchaser you may physically transfer the products from one location to another provided that the software firmware is not copied You may not electronically transfer the software firmware from the products to any other device You may not disclose publish translate release or distribute copies of the software firmware or accompanying written materials to others You may not modify adapt translate reverse engineer decompile disassemble or create derivative works based on the software firmware You may not modify adapt translate or create derivative works based on the written materials without the prior written consent of MASIMO 6 Transfer Restrictions The software firmware is licensed to the Purchaser and may not be transferred to anyone except other end users without the prior written consent of MASIMO In no event may you transfer assign rent lease sell or otherwise dispose of the software firmware or the products on a temporary basis 7 Beneficiary Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its provisions 8 US Government Rights If you are acquiring so
83. kg Docking Station RDS 1B RDS 3B 4 11 Ibs 1 86 kg Standalone RDS 1 RDS 2 RDS 3 RDS 4 3 8 Ibs 1 73 kg Standalone RDS 1B RDS 3B 5 4 lbs 2 45 kg trending 72 hours of trending at 2 second resolution up to 30 days of trending at 10 second resolution output to serial printer or other serial devices modes Averaging mode 2 4 8 10 12 14 or 16 seconds Sensitivity Normal and Maximum and APOD alarms Audible and visual alarms for high low saturation and pulse rate SpO range 1 100 pulse rate range 25 240 bpm Sensor condition system failure and low battery alarms High Priority 571 Hz tone 5 pulse burst pulse spacing 0 250s 0 250s 0 500s 0 250s repeat time 10s Medium Priority 550 Hz tone 3 pulse burst pulse spacing 0 375s 0 375s repeat time 7s Low Priority 500Hz tone 1 pulse burst repeat time 5s Alarm Muted reminder 500Hz tone 2 pulse burst pulse spacing 0 375s repeat time 3min Alarm Volume High Priority 88 9 dB max Medium Priority 88 9 dB max Low Priority 88 7 dB max display Indicators Data display SpOz pulse rate pleth waveform alarm status trends status messages Signal IQ perfusion index APOD and FastSat Display Color Blue Type Backlit LCD Pixels 480 x 160 dots Dot Pitch 0 25 mm output interface SatShare RDS 1 RDS 1B RDS 4 Radical Signal Extraction Pulse Oximeter Operator s Manual
84. le Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical RadNet setup CAUTION SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED NOTE Confirm that the Radical Docking Station is RadNet Ready before preceeding 1 Select the ASCII 2 selection from the Output menu on the Radical 2 Connect one end of the serial cable to the Serial Output connector on the back of the Docking Station Connect the other end of the serial cable to the RadNet Interface Module connector Turn the RadNet Interface Module on The SpO and pulse rate values will automatically appear on the RadNet Central Station Monitor screen 6 In order for the pleth waveform to be displayed on the RadNet Central Station Monitor screen and for the RadNet Central Station Monitor monitor to indicate the alarm conditions measured by the pulse oximeter the user must configure the RadNet Central Station monitor Please see the RadNet Hardwired and Wireless Systems Operator s Manual for complete instructions Radical Signal Extraction Pulse Oximeter Operator s Manual 3 7 a setup 6 The Radical can be set up to audibly indicate all patient alarms while communicating with the RadNet Interface module Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical CAUTION REMOVING THE RADICAL HANDHELD FROM THE RADNET READY DOCKING STATION WILL CAUSE LOSS OF COMMUNICA
85. log output and interfaces to serial printers Utilizing a SatShare cable the standalone Radical also interfaces with the SpO input of a validated multiparameter patient monitor instantly upgrading the j conventional pulse oximetry to Masimo SET pulse oximetry The SatShare cable attaches to the back of the Radical Docking Station and SatShare cables are available to interface with most multiparameter patient monitors CAUTIONS W THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL NON NORMALIZED REFER TO THE RADICAL DISPLAY FOR PATIENT WAVEFORM MIF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE IT IS RECOMMENDED TO TURN OFF THE PLETH WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR MONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED Refer to Section 3 SatShare Setup and Section 4 SatShare Operation for additional details Contact Masimo for the latest list of SatShare validated multiparameter monitors Radical Signal Extraction Pulse Oximeter Operator s Manual 2 1 System description 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 ch
86. lties experienced with the Pulse Oximeter Please include the RMA number in the letter Wi Warranty information a copy of the invoice or other applicable documentation must be included Wi Purchase order number to cover repair if the oximeter is not under warranty or for tracking purposes if it is Wi Ship to and bill to information Wi Person name telephone Telex fax number and country to contact for any questions about the repairs Wi Acertificate stating the oximeter has been decontaminated for bloodborne pathogens Return the Radical to the following shipping address For USA For Europe For Asia Pacific Masimo Corporation Masimo Europe Limited Masimo Japan Corporation 40 Parker 304 RN6 Le Bois des Cotes 2 World Times Bldg 4F Irvine California 92618 69760 Limonest 10 7 Ichiban cho Chiyoda ku 949 297 7000 France Tokyo 102 0082 JAPAN Tel 33 0 472 17 93 70 Tel 03 3237 3057 FAX 33 0 478 35 78 08 FAX 03 3238 1110 Radical Signal Extraction Pulse Oximeter Operator s Manual 9 9 d service and maintenance 9 10 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 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 oximeter Batteries are warrantied for six 6
87. months To request a replacement under warranty contact the licensed manufacturer or Masimo for a returned goods authorization If the licensed manufacturer or Masimo determines that a product must be replaced under warranty it will be replaced and the cost of shipment covered All other shipping costs shall be the responsibility of the purchaser Exclusions This warranty does not extend to any product that has been subject to misuse neglect or accident that has been damaged by causes external to the Product that has been used in violation of the operating instructions supplied with the product The warranty does not extend to any product that has been connected to an unlicensed instrument system modified accessories or any unit that has been disassembled or reassembled by anyone but an authorized Masimo agent THIS WARRANTY TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS TO MASIMO S PRODUCTS THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE MASIMO SHALL NOT BE LIABLE FOR ANY INCIDENTAL SPECIAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM THE USE OR LOSS OF USE OF ANY PRODUCTS End user license agreement THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU THE PURCHASER AND Masimo Corporation MASIMO IF YOU DO
88. mple by wrapping the sensor too tightly Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor CAUTIONS DO NOT USE DAMAGED SENSORS DO NOT USE A SENSOR WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS DO NOT IMMERSE THE SENSOR IN WATER SOLVENTS OR CLEANING SOLUTIONS THE SENSORS AND CONNECTORS ARE NOT WATERPROOF DO NOT STERILIZE BY IRRADIATION STEAM AUTOCLAVE OR ETHYLENE OXIDE SEE THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE MASIMO SENSORS DO NOT USE DAMAGED PATIENT CABLES DO NOT IMMERSE THE PATIENT CABLES IN WATER SOLVENTS OR CLEANING SOLUTIONS THE PATIENT CABLE CONNECTORS ARE NOT WATERPROOF DO NOT STERILIZE BY IRRADIATION STEAM AUTOCLAVE OR ETHYLENE OXIDE DO NOT ATTEMPT TO REPROCESS RECONDITION OR RECYCLE MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS POTENTIALLY LEADING TO PATIENT HARM Radical Signal Extraction Pulse Oximeter Operator s Manual E operation NUMERIC DISPLAY SpO Stability of the SpO readings may be a good indicator of signal validity Although stability is a relative term experience will provide a good feeling for changes that are artifactual or physiological and the speed timing and behavior of each The stability of the readings over time is affected by the averaging mode being used The longer the averaging time the more stable the reading
89. nd information on an analog chart recorder PRINT To print the trend data that is shown in the Trend View select the Print option The trend data is first printed in histogram format followed by a table of data that shows the time and date stamp of a trend record and the SpO PI 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 operation EF MENU ITEM DESCRIPTION The Trend period setting determines how often a set of SpO PI and pulse rate data points is stored in trend memory A setting of 2 for example sets the Radical to store one set of SpOs PI and pulse rate TREND PERIOD measurements every 2 seconds resulting in a minimum trend capacity of 87 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 18 days NOTE Since the Radical employs a sophisticated data compression scheme the actual trend capacity is dependent on the type of data that is collected Backlight contrast operation The backlit LCD screen of the Radical Handheld can be set to four levels of illumination in addition to no illumination when Radical operates as a standalone pulse oximeter The Radical temporarily indicates the illumination level on the display following a change in illumination level To select
90. nsor failed Replace sensor Refer to the instructions for the sensor being used Charge battery by placing the Radical Handheld into the Docking Station and LOW BATTERY Battery charge is low powering the unit with AC line power Replace battery if necessary Move sensor to better perfused site Refer LOW PERFUSION Signal too small to Section 4 Low Perfusion Ensure proper sensor application Move LOW SIGNAL IQ Low signal quality sensor to a better perfused site Refer to Section 4 Signal IQ Radical Signal Extraction Pulse Oximeter Operator s Manual alarms messages 5 Alarm operation The Radical audibly alarms when the saturation measurement or pulse rate measurement exceeds the low or high saturation or pulse rate alarm limits The Radical allows a user to delay audible saturation alarms by 0 5 or 10 seconds by selecting the appropriate setting in the Alarm Delay menu A delayed saturation alarm is visually indicated by a flashing alarm bell on the Radical display and a flashing saturation and alarm limit indicator An active alarm condition is visually indicated by a flashing alarm bell a flashing saturation and alarm limit indicator on the Radical display and a flashing red alarm indicator on the Docking Station Saturation changes of greater than 5 in excess of the alarm limit are indicated immediately regardless of alarm delay setting In addition alarms are audibly indicated according to th
91. nsor or input connector It is recommended that the Radical is positioned close to the multiparameter monitor with the Radical screen visibly displaying the plethysmographic waveform and the saturation and pulse rate measurements CAUTION SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED Radical Signal Extraction Pulse Oximeter Operator s Manual setup B SATSHARE SETUP 1 10 Select the SatShare cable that is appropriate for the multiparameter monitor that is being connected Check the Masimo web site at www masimo com for the latest list of available SatShare cables and validated instruments Abad 1 KAMA Lens Li O S T ee Connect the labeled end of the cable to the SatShare Cable Connector port on the back of the Docking Station Tighten the connector screws for a secure connection Connect the other end of the SatShare cable either to the sensor connector of the multiparameter monitor s SpO cable or directly to the SpO connector on the monitor Verify that the Radical recognizes the correct cable The name of the SatShare cable will be displayed on the LCD screen when the SatShare mode is functional Set the multiparameter monitor s high and low saturation and pulse rate alarm limits as appropriate Set the multiparameter monitor s averaging time to the lowest setting i e fastest response The Radical s ideal waveform obviates the need for additional averaging by the monitor
92. o the common pin and the normally closed will be disconnected In addition the nurse call polarity can be inverted to accommodate various nurse call stations requirements The nurse call relays have the following electrical specifications per switch PARAMETER SPECIFICATION MAX VOLTAGE 100VDC or AC peak MAX CURRENT 100mA WARNING THE NURSE CALL FEATURE IS DISABLED WHEN THE AUDIBLE ALARMS ARE SILENCED WHILE THE NURSE CALL SETTING IN THE OUTPUT MENU IS SET TO ALARMS Radical Signal Extraction Pulse Oximeter Operator s Manual sensors amp patient cables d Introduction This section covers the use and cleaning of Masimo SET sensors and Masimo SET patient cables Masimo SpOg sensors Before use carefully read the sensor Directions for Use Use only Masimo oximetry sensors for SpO measurements Other oxygen transducers or sensors may cause improper Radical performance Tissue damage can be caused by incorrect application or use of a Masimo sensor for example by wrapping the sensor too tightly Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor CAUTIONS W DO NOT USE DAMAGED SENSORS OR PATIENT CABLES DO NOT USE A SENSOR OR PATIENT CABLE WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS W DO NOT IMMERSE THE SENSOR OR PATIENT CABLE IN WATER SOLVENTS OR CLEANING SOLUTIONS THE SENSORS AND CONNECTORS ARE NOT WATERP
93. ols are not available in all versions of the Docking Station SYMBOLS lt gt RS 232 DEFINITION RS 232 SatShare interface Equipotential Ground Terminal See Instructions for Use Fuse Replacement Analog Out Interface Nurse Call Interface WEEE Compliant Mark of Conformity to European Medical Device Directive 93 42 EEC Rx ONLY Federal law restricts this device to sale by or on the order of a physician USA audiences only il e UL us Underwriter s Laboratories Inc approved Storage humidity range 5 to 95 J 3 Storage temperature range 70C to 40C Storage altitude range 1600hPa to 500hPa Keep dry Fragile breakable handle with care Gd iial Year of Manufacture IPX1 Protection against liquid drops falling vertically LS Radical Signal Extraction Pulse Oximeter Operator s Manual 2 9 Defibrillation Proof Type BF e system description Radical monitor interface In addition to being a full featured Handheld and Standalone Pulse Oximeter Radical s unique SatShare interface links the Radical to most existing multiparameter patient monitors through the pulse oximetry patient cable or SpO input connector Wi Upgrades any approved and validated monitor to Masimo SET performance by using the calculated SpO and pulse rate determined by Radical to simulate an ideal waveform which is sent to the validated multiparamete
94. overed by one or more of the following U S Patents RE38 492 RE38 476 6 850 787 6 826 419 6 816 741 6 699 194 6 684 090 6 658 276 6 654 624 6 650 917 6 643 530 6 606 511 6 584 336 6 501 975 6 463 311 6 430 525 6 360 114 6 263 222 6 236 872 6 229 856 6 206 830 6 157 850 6 067 462 6 011 986 6 002 952 5 919 134 5 823 950 5 769 785 5 758 644 5 685 299 5 632 272 5 490 505 5 482 036 international equivalents or one or more of the patents referenced at www masimo com patents Products containing Satshare feature are also covered by U S Patent 6 770 028 Other patents pending 2007 Masimo Corporation Masimo Radical Discrete Saturation Transform DST Satshare SET LNOP LNCS and LNOPv are federally registered trademarks of Masimo Corporation RadNet RadicalScreen Signal IQ FastSat FastStart and APOD are trademarks of Masimo Corporation Radical Signal Extraction Pulse Oximeter Operator s Manual 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 High intensity extreme lights such as pulsating strobe light
95. play automatically refreshes at a rate of once every 10 seconds to show the latest measured SpO PI or pulse rate data This feature is only available while the trend view is 2 hours or less and the latest measured data is shown If the user scrolls through the data set to display previously recorded trend data or if the trend scale is greater than 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 operation Ey 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 FIRST PAGE NEXT MENU Press the Next Menu Page button to access the next page of menu gt PAGE selections EXIT Press the Exit button to return to the normal display screen Press the Scroll Right button to scroll through the data set The SCROLL display scrolls by the selected time scale For example if a 2 hr RIGHT display view is selected then pressing the Scroll Right button will scroll the displayed data by 1 hr to the right Press the Scroll Left button to scroll through the data set The SCROLL display scrolls by the selected time scale For example if a 2 hr LEFT display view is selected then
96. put mode in the Output menu To interface with the Radical and receive serial text data simply connect a serial interface cable with a ferrite bead installed to the serial output connector located on the back of the Radical Docking Station NOTE The Radical serial interface is only available when the Radical Handheld is properly attached to the Radical Docking Station NOTE The serial interface is not available in all versions of the docking station Once serial communication is established packets of data are communicated at 1 second intervals The data packets contain the date time SpO pulse rate perfusion index and alarm and exception values in ASCII format WARNING ALL EXTERNAL DEVICE CONNECTIONS TO THE ANALOG OUTPUT NURSE CALL CONNECTOR MUST BE IEC 60950 COMPLIANT Radical Signal Extraction Pulse Oximeter Operator s Manual E 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 9 V 5 Vmin 4 No Connec
97. r patient monitor Wi Connects into the SpO patient cable or SpO input connector of the multiparameter patient monitor Refer to Section 3 SatShare Setup and Section 4 SatShare Operation for additional details CAUTION THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT MONITOR IS A SIMULATED SIGNAL REFER TO THE RADICAL DISPLAY FOR THE PATIENT WAVEFORM CAUTION ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED Radical Signal Extraction Pulse Oximeter Operator s Manual setup B 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 it for signs of shipping damage Check all materials against the packing list Save all packing materials invoice and bill of lading These may be required to process a claim with the carrier If anything is missing or damaged contact the Technical Service Department The contact address and phone numbers are listed in Section 9 Service and Repair Preparation for monitoring The following sections of the manual describe the preparation set up and initial installation of the Radical Pulse Oximeter RADICAL POWER REQUIREMENTS Always use a hospital grade AC power cable to connect the Radical Pulse Oximeter to an AC power source Do not connect the Radical Pulse Oximeter Docking Station
98. ration SpO MEDIUM Audible and visual alarms for Desat Index See 3D Alarm System option PRIORITY Audible and visual alarms for Perfusion Index Delta See 3D Alarm System option LOW PRIORITY Audible and visual alarms for low battery NOTE High priority alarms indicate that immediate operator response is required Low priority alarms indicate that operator awareness is required Radical Signal Extraction Pulse Oximeter Operator s Manual 5 1 5 alarms messages System 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 Too much light on patient AMBIENT LIGHT sensor Inadequate tissue covering sensor detector Remove or reduce lighting Cover sensor from light Reposition sensor Broken sensor cable wire or inoperative LEDs or faulty detector Replace sensor Refer to the instructions for the sensor being used DEFECTIVE Oximeter cannot identify SENSOR the connected sensor the sensor has failed Outside signal or energy rs INTERFERENCE preventing reading Remove outside interference Broken sensor cable wire or inoperative Oximeter cannot identify LEDs or faulty detector the sensor has INVALID SENSOR the connected se
99. s directed on the sensor may not allow the Pulse Oximeter to obtain vital sign readings The Pulse Oximeter is NOT intended for use as an apnea monitor A Pulse Oximeter should be considered an early warning device As a trend towards patient hypoxemia is indicated blood samples should be analyzed by laboratory instruments to completely understand the patient s condition The Pulse Oximeter is to be operated by qualified personnel only This manual accessory directions for use all precautionary information and specifications should be read before use Electric shock hazard Do not open the pulse oximeter cover except to replace the battery of the Handheld unit Only a qualified operator may perform maintenance procedures specifically described in this manual Refer servicing to Masimo for repair of this equipment As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation Do not place the pulse oximeter or accessories in any position that might cause it to fall on the patient Do not lift the pulse oximeter by the power cord or any other cable Interfering Substances SpO is a functional calculation of arterial oxygen saturation Carboxyhemoglobin and Methemoglobin may erroneously increase SpO readings The level of increase is approximately equal to the amount of carboxyhemoglobin and or methemoglobin that is present Dyes or any substance containing dyes th
100. s tend to become This is due to a dampened response as the signal is averaged over a longer period of time than during shorter averaging times However longer averaging times delay the response of the oximeter and reduce the measured variations of SpO and PR 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 aortic balloon support can be additive to the pulse rate displayed on the pulse oximeter Radical Signal Extraction Pulse Oximeter Operator s Manual operation EF SIGNAL IQ The Radical display provides a visual indicator of the plethysmogram signal quality and an alert when the displayed SpO 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 The Signal IQ shown as a vertical line coincides with the peak of
101. ssssssse eee 4 4 SIGNAL zu erect ot REED E DR EMAIL Un EMEN 4 5 LOW POMUSION 5 20 qasideyace a eR E DO o e tp pp IRE ntn de s v veles 4 6 Actions To Be Taken isis se ee ee phe hte bd 4 6 Sensitivity 2 55e Gee en ali ep exo RR att eR 4 7 Touch key control button and icons s s keene eee eed 4 8 Traditional user interface 6 ccc ee 4 8 Radical Signal Extraction Pulse Oximeter Operator s Manual table of contents First Pages sgin toad a dscts vast wee Baits f AREE MAS ER dus 4 8 Secondpage sss 4 8 Simplified user interface o ecco ed e ean eee eed 4 9 First page ose RR dean edna C o DERI ER rer ada 4 9 Second Page s voor or ce entreprendre oni aie qd TO 4 9 Navigating the main menu 4 10 Main menu selection ssessssssse teen ee 4 10 Menu categories ssssssssssseI ne 4 10 Editing a parameter ciscisiee eere eR eee 4 11 Menu tree crsa ees oe e eerte RUNDE Ot ER RS eL a od 4 11 AIANINS 4 o steterat septi UEBER Ed Ete Eran et d reis 4 13 Display ie ote odoe eese b n erepto PE e a P Ree Wd ee 4 16 Gernieral 4 i4 esse tede ted decr pale ym i dept atu e ER ANE 4 17 lelo e ole Re Arp RARE FR eg HA O RICE YE ERAS 4 17 Dung ga LE 4 17 or 4 17 CUPU 5 nct desee rr EUR E VU tidal itus ded dua 4 18 SERVICES ERROR Er E ate Sates taster AAEE NN eremteiees 4 20 Trend display oue e E E FRU RON DUR S ET EMEN ERR E UN 4 21 Navigating the trend display sisse RR 4 23 First page iid
102. tery Charging Indicator is illuminated when D RN BATTERY the Handheld battery is charging The indicator blinks just prior CHARGING to charging The Charging Indicator does not illuminate when INDICATOR the battery is fully charged or when the battery is not present VISUAL a The Visual Alarm Indicator is illuminated when an alarm INDICATOR condition is active and the Alarm Status Indicator is shown Docking Station is plugged into AC line power DOCKING The Docking Indicator is illuminated when the Handheld unit is INDICATOR turned on and is properly interfaced to a Docking Station a a AC POWER The AC Power Indicator is illuminated when the Radical INDICATOR 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 a system description 2 8 STANDALONE BACK PANEL SERIAL OUTPUT CONNECTOR Use the Serial Output Connector with a ferrite bead installed to connect a serial device including a serial printer RadNet Interface Module 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 ANALOG OUTPUT NURSE CALL CONNECTOR Use the Analog Output Connector with a ferrite bead installed to interface with an analog outp
103. tion 5 Signal Ground Reference for COM signals 6 No Connection 7 No Connection 8 No Connection 9 No Connection SERIAL PRINTER SETUP To print the SpO and pulse rate data in ASCII1 format on a serial printer simply connect the laser printer to the serial port Once serial communication is established the Radical will automatically start printing the ASCII1 text data WARNING ALL EXTERNAL DEVICE CONNECTIONS TO THE RS 232 SERIAL PORT MUST BE IEC 60950 COMPLIANT 7 4 Radical Signal Extraction Pulse Oximeter Operator s Manual specifications Ea 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 Only use an analog nurse call cable that has a ferrite bead installed NOTE The analog output nurse call interface is not available in all versions of the Docking Station The following table shows the pinout of the analog output and nurse call PIN SIGNAL NAME 1 5V 60mA max 2 Ground 3 Ground 4 Ground 5 Ground 6 Nurse Call Normally Open 7 Nurse Call Normally Closed 8 Ground 9 Analog 1 10 Ground 11 Ground 12 Nurse Call Common 13 Ground 14 Ground 15 Analog 2 Radical Signal Extraction Pulse Oximeter Operator s Manual
104. to sm daba ce OU REIR A eL S E da 7 6 Nurse Calli 2a iiic le AR vena dee debe vedere peek RR A dA e br 7 6 Radical Signal Extraction Pulse Oximeter Operator s Manual vi table of contents SECTION 8 SENSORS amp PATIENT CABLES Introduction fitters iad rp erupit REC IS 8 1 Masimo SpO5 SErISOFS Scio mette eurn vp eedem EU eo detti e eut 8 1 Selecting a Masimo Set Sensor esee 8 1 Sensor Application Site sos rece laden exten deer vv is a 8 2 LNOP Reusable Sensors 8 2 LNOP Adhesive Sensors 0 0 c cece eect eet eee enna 8 2 LNOP specialty Sensors 8 3 LNOPv Adhesive Sensors 0 0c eee eee eee tenets 8 3 LNCS Reusable Sensors i riri pior exor tes meom eer Se EDO Ye 8 3 LNCS Adhesive Sensors 8 4 Cleaning And Reuse Of Masimo Sensors 00 e eee eee eee 8 4 Reattachment of Single Use adhesive Sensors 00 0 00 8 4 Masimo SET patient cables 0 0 cc cece cence cence tenet ene eenees 8 5 Cleaning And Reuse Of Masimo SET Patient Cables 00 8 5 SECTION 9 SERVICE AND MAINTENANCE Introduction eder eden te Aa Rewer ovr RR DEI RN AIPRRS AA a 9 1 Cleaning e eco EDO e e ie etna dae eol Uv P eS 9 1 Battery operation and maintenance 9 2 Replacing the Batteries lsssssssessesse tee eneee 9 4 Replacing the F ses 22 oder br m b bene e ER IR RR Wes 9 5 Performance verification lssssessssesese I 9 5 Service and repait 5 e mea r
105. tting TREND PERIOD Set to pre power down setting LOW SpO ALARM LIMIT Set to pre power down setting ADULT NEO HOSPITAL DEFINED SETTINGS The following table outlines settings that may be defined by the hospital If enabled via a password protected screen these settings will return to pre defined values after a power cycle This mode is indicated by Mode Adult or Mode Neo on the Alarms menu See Section 4 Output for details on enabling and setting these parameters ADULT NEO SETTING OPTION CUSTOM SETTING PRE DEFINED SPO HIGH LOW Set to pre power down settin ALARM LIMIT aid i PULSE RATE HIGH LOW ALARM Set to pre power down setting LIMIT Set to pre defined ALARM SILENCE Set to 120 seconds Adult or Neo setting ALARM VOLUME Set to pre power down setting The 0 and 5 second setting is ALARM DELAY retained the 10 second setting is set to 5 seconds 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 The SatShare feature provides an ideal simulated waveform corresponding to the measured saturation and pulse rate values determined by the Masimo SET technology This waveform may be used to display these values on multiparameter monitors through the multiparameter monitor s oximetry se
106. uid Crystal Display LCD that continuously displays numeric values for SpO pulse rate plethysmographic waveform and Signal Identification and Quality Indicator Signal Q The Radical can be used to interface with a multiparameter patient monitor to provide Masimo SET pulse oximetry information to that monitor for display FEATURES AND BENEFITS Wi Clinically proven as the highest sensitivity and specificity pulse oximeter in the world Wi Signal IQ waveform for signal identification and quality indication during excessive motion and low signal to noise situation FastSat tracks rapid changes in arterial Oo with high fidelity unlike any other pulse oximeter Wi FastStart allows for rapid measurement from the time the instrument is first turned on m APOD Adaptive Probe Off Detection offers the best probe off detection of Masimo s three sensitivity modes APOD Normal and MAX sensitivity Wi ClearVue technology delivers the highest resolution display available SmartTone beeps in sync with pulse and with tonal changes for every 1 drop in saturation even under most patient motion conditions SatShare interface connection to existing multiparameter monitor models RDS 1 1B only RS 232 analog output and nurse call interfaces models RDS 1 1B and RDS 3 only User configurability maximizes operation for all applications Facilitates economical sensor standardization throughout the hospital SpO pulse rate alarm trending perf
107. uires service WARNING FIRE HAZARD TO PROTECT AGAINST FIRE HAZARD REPLACE ONLY WITH FUSES OF THE SAME TYPE CURRENT RATING AND VOLTAGE RATING Performance verification To test the performance of the Radical 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 Before performing the following tests place the Radical Handheld into the Docking Station connect the Radical to AC power and fully charge the Radical Handheld battery Also disconnect any patient cables or pulse oximetry probes as well as SatShare serial or analog output cables from the instrument Set the Radical to normal operating mode by selecting the Home Use parameter in the General Menu to No Radical Signal Extraction Pulse Oximeter Operator s Manual 9 5 d service and maintenance 9 6 Power On Self Test 1 2 Connect the monitor to AC power and verify that the AC Power Indicator is lit 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 The blue Docking Indicator LED is illuminated and the Radical begins normal operation Key Press Button Test 1 With the exception of the Power Standby Button press each soft key button and ver
108. usion index Signal IQ and plethysmographic waveform display Automatic screen rotation provides upright display for vertical or horizontal monitor positioning not available on the RDS 2 model Wi Remote alarming interface Wi Designed for hospital transport and home use Wi Upto thirty days of trending INDICATIONS FOR USE The Radical and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin SpO and pulse rate measured by an SpO sensor The Radical and accessories are indicated for use with adult pediatric and neonatal patients during both motion and no motion conditions and for patients who are well or poorly perfused in hospitals hospital type facilities mobile and home environments In addition the is indicated to provide continuous noninvasive monitoring data to validated multiparameter patient monitors for display on those monitors Contact Masimo for the latest list of SatShare validated multiparameter monitors Radical Signal Extraction Pulse Oximeter Operator s Manual HW Overview 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 coll
109. ut device such as a chart recorder or nurse call system All external device connections to the Analog Output Nurse Call Connector must be IEC 60950 compliant SATSHARE CABLE CONNECTOR Use the SatShare Cable Connector to connect a SatShare cable to the SpO input connector of a multiparameter patient monitor All external device connections to the SatShare Cable Connector must be IEC 60601 1 compliant SatShare cables are available to interface with most major multiparameter patient monitors Check the label on the SatShare cable and the SatShare Directions for Use to ensure that the correct cable is used for each type of patient monitor Refer to the Masimo web site at www masimo com for the latest SatShare cables and validated instruments POWER ENTRY MODULE The power entry module contains the input connector for AC power and two fuses The AC input provides power to the system from the AC line Always connect the pulse oximeter to the mains power for continuous operation and or battery recharging NOTE Use the power cord as the means to disconnect the device from the mains power supply EQUIPOTENTIAL GROUND CONNECTOR Use the Equipotential Ground Connector for grounding Radical Signal Extraction Pulse Oximeter Operator s Manual System description pe SYMBOLS The following symbols are found on the Radical unit Docking Station or packaging and are defined below NOTE Some of the interfaces and symb
110. waveform to be displayed on the Philips monitor and for the Philips monitor to indicate the alarm conditions measured by the pulse oximeter the user must configure the Philips monitor Please see the Philips Operator s manual for complete instructions Radical Signal Extraction Pulse Oximeter Operator s Manual setup B 6 The Radical Pulse Oximeter can be set up to audibly indicate all patient alarms while communicating with the Philips module Use the Interface Alarms setting in the General menu to enable and disable audible alarms on the Radical Spacelabs universal flexport setup CAUTION SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT SUPPORTED 1 Selectthe Spacelabs Flexport selection from the Output menu on the Radical 2 Connect one end of the Spacelabs Flexport cable to the Serial Output connector on the back of the Docking Station 3 Connect the other end of the Spacelabs Flexport cable to the Spacelabs Universal Flexport connector The SpO and pulse rate values will automatically appear on the Spacelabs screen In order for the pleth waveform to be displayed on the Spacelabs screen and for the Spacelabs monitor to indicate the alarm conditions measured by the pulse oximeter the user must configure the Spacelabs monitor Please see the Spacelabs monitor Operator s manual for complete instructions 6 The Radical can be set up to audibly indicate all patient alarms while communicating with the Spacelabs Flexport modu
111. ws Wi All visual alarms remain active Bi Allaudible alarms may be disabled by software configuration of the Radical Wi The SpO and pulse rate numbers may or may not be displayed on the Radical display depending on the SatShare Numbers setting of the General menu Wi All other items are displayed including the alarm limits the plethysmogram and Signal IQ waveform Wi The user can access the menu system Mf 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 II Once Radical detects the presence of a patient monitor the SatShare cable type remains constantly displayed on the LCD screen Wi Patient Alarms of the multiparameter patient monitor will be triggered by the alarm setting of the patient monitor and not the Radical To synchronize the alarm events set the alarm limits of the Radical to those of the patient monitor or vice versa WI Once Radical detects that the SatShare cable is disconnected from the patient monitor or if the patient monitor is turned off Radical automatically returns to normal standalone operation Inthe SatShare mode the pulse beep tone of the Radical is initially set to the lowest volume mute The pulse beep volume can be manually increased The Radical may automatically set the averaging time during SatShare operation For averaging times of 10 seconds and higher the Radical will automatically set the averaging t

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