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Pulse CO-Oximeter

with Rainbow

Technology

OPERATOR’S

MANUAL

Summary of Contents for Radical-7R

Page 1: ...Pulse CO Oximeter with Rainbow Technology OPERATOR S MANUAL...

Page 2: ...y or on the order of a physician Masimo Corporation 40 Parker Irvine CA 92618 USA Tel 949 297 7000 Fax 949 297 7001 www masimo com Covered by one or more of the following U S Patents RE38 492 RE38 476...

Page 3: ...me lights including pulsating strobe lights directed on the sensor may not allow the Pulse CO Oximeter to obtain readings Excessive ambient noise may affect the accuracy of the respiration rate readin...

Page 4: ...pected laboratory analysis CO Oximetry of a blood sample should be performed Elevated levels of Methemoglobin MetHb will lead to inaccurate SpO2 and SpCO measurements Elevated levels of Carboxyhemoglo...

Page 5: ...th the limits for medical instruments to the EN 60601 1 2 2002 Medical Instrument Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in a typic...

Page 6: ...echnology SET 1 7 SpCO SpMet and SpHb Measurements During Patient Motion 1 8 Rainbow Acoustic Monitoring 1 8 Masimo Rainbow SET Parallel Engines 1 10 Masimo SET DST 1 10 SECTION 2 SYSTEM DESCRIPTION I...

Page 7: ...y Index PVI 4 8 Low Perfusion 4 8 Actions To Be Taken 4 8 Sensitivity 4 9 Touch Key Control Button and Icons 4 10 Traditional User Interface 4 10 Navigating the Main Menu 4 11 Main Menu Selection 4 11...

Page 8: ...nsors 8 4 M LNCS LNCS Reusable Sensors 8 4 M LNCS LNCS Adhesive Sensors 8 5 M LNCS LNCS Specialty Sensors 8 5 Sensor Accuracy 8 6 Cleaning And Reuse Of Masimo Reusable Sensors and Cables 8 6 Reattachm...

Page 9: ...cribes the Radical 7R Pulse CO Oximeter system and its functions and features SECTION 3 SETUP describes how to setup the Radical 7R Pulse CO Oximeter for use SECTION 4 OPERATION describes the operatio...

Page 10: ...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...

Page 11: ...e RRa while providing the Respiration Indicator RI at the sensor site SIQa displays the confidence level of the Acoustic Respiration measurement signal quality Total Oxygen Content SpOC provides a cal...

Page 12: ...ngertip for adults and the hand or foot for neonates The sensor is connected to the Pulse CO Oximetry instrument with a patient cable The sensor collects signal data from the patient and sends it to t...

Page 13: ...gen The oxygen content is determined mathematically as CaO2 1 34 ml O2 g Hb x Hb g dl x HbO2 PaO2 mm Hg x 0 3 ml O2 100 mm Hg dl Where HbO2 is the fractional arterial oxygen saturation and PaO2 is the...

Page 14: ...mount of arterial blood in tissue changes with your pulse photoplethysmography Therefore the amount of light absorbed by the varying quantities of arterial blood changes as well The Radical 7R Pulse C...

Page 15: ...ation of methemoglobin in the blood gas sample is abnormal greater than 2 for methemoglobin concentration High levels of bilirubin may cause erroneous SpO2 SpMet SpCO and SpHb readings As blood sample...

Page 16: ...achea to the surface where they may be heard with the aid of a stethoscope a microphone or more sophisticated devices Rainbow Acoustic Monitoring Architecture The following figure illustrates how a re...

Page 17: ...be real time and continuous The respiratory cycle envelope signal processing principle is similar to methods that sample airway gases and subsequently determine a respiratory rate 1 A R A Sovij rvi F...

Page 18: ...1 10 Radical 7R Pulse CO Oximeter Operator s Manual 1 MASIMO SET DST O v e r v i e w MASIMO RAINBOW SET PARALLEL ENGINES This figure is for conceptual purposes only SpOC 12 FST MST...

Page 19: ...one Pulse CO 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 7R features...

Page 20: ...l 7R Pulse CO Oximeter system The patient cable connects into the connector on the Handheld instrument The Handheld is battery powered and can be used either as a transport monitor or as a Handheld Pu...

Page 21: ...nsor Off will appear at the top of the display screen The methemoglobin is calculated and the display is updated at a frequency of once per second 6 3 0 __ SpMet ALARM LIMITS DISPLAY The SpMet Alarm L...

Page 22: ...EAKER The speaker indicates audio alarms Care should be taken not to cover the speaker and muffle the audible alarm volume 16 PATIENT CABLE CONNECTOR Connect a patient cable or a direct cable sensor i...

Page 23: ...play shows the confidence level of the Acoustic Respiration measurement signal quality as a percentage between 1 and 100 28 40 6 RESPIRATION RATE ALARM LIMITS DISPLAY The Respiration Rate RRa Alarm Li...

Page 24: ...STATION CONNECTOR The Radical 7R Handheld interfaces with the Docking Station through this connector 2 POLE CLAMP ACCESSORY HOLDER The optional Pole Clamp accessory attaches to this holder See the Dir...

Page 25: ...ne can also interface to serial instruments nurse call or analog output instruments and multiparameter patient monitors through a SatShare cable There are several models of Docking Stations available...

Page 26: ...dicator is illuminated when the Handheld battery is charging The indicator blinks just prior to charging The Charging Indicator does not illuminate when the battery is fully charged or when the batter...

Page 27: ...ust be IEC 60950 compliant 3 SATSHARE CABLE CONNECTOR Use the SatShare Cable Connector to connect a SatShare cable to the SpO2 input connector of a multiparameter patient monitor All external instrume...

Page 28: ...ut Interface Nurse Call Interface WEEE Compliant Mark of Conformity to European Medical Instrument Directive 93 42 EEC Rx ONLY Federal law restricts this instrument to sale by or on the order of a phy...

Page 29: ...lse rate determined by Radical 7R to simulate an ideal waveform which is sent to the validated multiparameter patient monitor Connects into the SpO2 patient cable or SpO2 input connector of the multip...

Page 30: ...y be inadvertently switched off Verify the AC power voltage and line frequency before use Verify that the power source can provide adequate power rating as indicated on the rear panel of the Radical 7...

Page 31: ...e CO Oximeter Standalone instrument Make sure that the Radical 7R speaker is not covered to avoid a muffled alarm sound The Radical 7R Pulse CO Oximeter Handheld Docking Station or Standalone should n...

Page 32: ...itor that is being connected Check the Masimo web site at www masimo com for the latest list of available SatShare cables and validated instruments 2 Connect the labeled end of the cable to the SatSha...

Page 33: ...l 7R reverts to Interface Alarm SpO2 BPM Yes during power interruptions or when the SatShare connection is lost or the device becomes separated from the docking station This ensures that the Radical 7...

Page 34: ...pO2 BPM YES DURING POWER INTERRUPTIONS OR WHEN THE SATSHARE CONNECTION IS LOST OR THE INSTRUMENT BECOMES SEPARATED FROM THE DOCKING STATION THIS ENSURES THAT THE RADICAL 7R PROVIDES AUDIBLE ALARMS FOR...

Page 35: ...ve any substances that may interfere with the transmission of light between the sensor s light source and detector If using an Acoustic Respiration sensor ensure that the patient s neck area is clean...

Page 36: ...tion by lowering the SpO2 or pulse rate high alarm limits beyond the patient readings NOTE If using SpO2 and RRa only the SpO2 audible alarm tone will sound Press the Alarm Silence button The alarm to...

Page 37: ...ded Remove the cable connector from the instrument and reconnect Turn the power off and on at the instrument If a Masimo Rainbow Adhesive Sensor is being used and SpO2 Only Mode appears on the display...

Page 38: ...ignal 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 cause the pulse r...

Page 39: ...h comes with correct sensor placement small physiological changes during the measurement and acceptable levels of arterial perfusion at the measurement site Physiological changes at the measurement si...

Page 40: ...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 c...

Page 41: ...nal When the signal quality is very small the accuracy of the respiration rate measurement may be compromised When the RI is small the bar turns red and the parameter label flashes Proceed with cautio...

Page 42: ...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...

Page 43: ...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...

Page 44: ...tion indicators MENU ACCESS Press to enter the main menu SENSITIVITY Press to toggle between the Normal APOD and Maximum Sensitivity modes Use the Normal Sensitivity setting for typical monitoring pur...

Page 45: ...nu 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 EXIT Select the E...

Page 46: ...4 12 Radical 7R Pulse CO Oximeter Operator s Manual 4 O p e r a t i o n MENU TREE MAIN MENU ALARM LIMITS MENU...

Page 47: ...Radical 7R Pulse CO Oximeter Operator s Manual 4 13 4 O p e r a t i o n ABOUT MENU GENERAL MENU CONFIGURATION MENU...

Page 48: ...4 14 Radical 7R Pulse CO Oximeter Operator s Manual 4 AVERAGING MENU OUTPUT MENU FACTORY DEFAULTS MENU O p e r a t i o n...

Page 49: ...h alarm limit setting SpMet HIGH LIMIT The SpMet high alarm limit can be set anywhere between 1 0 to 99 5 then with a step increment of 0 1 SpMet LOW LIMIT The SpMet low alarm limit can be set as or a...

Page 50: ...bled Factory default setting is off PVI LOW LIMIT The PVI low alarm limit can be set as or anywhere between 1 and 98 with a 1 step size In the off setting the PVI Low Alarm Limit Alarm is disabled Fac...

Page 51: ...Version C o n f i g u r a t i o n MENU ITEMS DESCRIPTION Line Frequency Set to 50 or 60Hz Set to match regional power line frequency to allow for cancellation of noise introduced by fluorescent lights...

Page 52: ...all output will be activated based on Low Signal IQ events ALARM SIGNAL IQ The nurse call ouput will be activated based on alarm and Low Signal IQ events POLARITY NORMAL Standard polarity See Section...

Page 53: ...gered by the alarm setting of the patient monitor and not the Radical 7 Pulse CO Oximeter To synchronize the alarm events set the alarm limits of the Radical 7 Pulse CO Oximeter to those of the patien...

Page 54: ...R FOR AUDIBLE ALARM INDICATION THE RADICAL 7R SpO2 AND PULSE RATE AUDIBLE ALARMS MAY BE DISABLED WHEN THE RADICAL 7R IS CONFIGURED WITH RAINBOW PARAMETERS MEASUREMENTS REFER TO SECTION 4 ALARMS THE RA...

Page 55: ...ENT ALARM SETTING RANGE ALARMTYPE High Low arterial oxygen saturation Audible and visual High carboxyhemoglobin saturation High methemoglobin saturation Low total hemoglobin High total hemoglobin Low...

Page 56: ...stalled Use a non SpHb sensor Contact your local Masimo Representative to learn more about the optional SpHb upgrade REPLACE SENSOR Pulse CO Oximeter cannot identify the connected sensor Broken sensor...

Page 57: ...ms or ReSposable Pulse Oximeter Sensor Systems only Replace the reusable sensor REPLACE CABLE The patient cable is non functional or the life of the cable has expired Replace the patient cable INTERFE...

Page 58: ...isconnect and reconnect cable into connector NO SENSOR Sensor not fully inserted into the connector May be an incorrect sensor or a defective sensor or cable Insert sensor into connector Disconnect an...

Page 59: ...tive sensor or cable Insert sensor into connector Disconnect and reconnect sensor Refer to the instructions for the sensor being used INCOMPATIBLE AC SENSOR Not a proper Masimo sensor Replace with a p...

Page 60: ...e and check the LED again If the LED still fails to come on replace the sensor and or cable SpO2 NUMBER FLASHES Saturation alarm limit exceeded Assess address patient condition Re set alarm limits if...

Page 61: ...e sensor to better perfused site UNEXPECTED SpO2 SpCO SpMet OR SpHb READING Low SIQ or Perfusion Index PI values Reposition sensor to site with strong SIQ and PI Average readings taken from three diff...

Page 62: ...d Interference from line frequency induced noise Verify set 50 60hz menu setting Refer to Section 3 Initial Setup for details Inappropriate sensor or sensor size Verify proper sensor and sensor size f...

Page 63: ...ion 70 to 100 No Motion2 Adults Infants Pediatrics 2 Neonates 3 Motion3 Adults Infants Pediatrics Neonates 3 Low Perfusion4 Adults Infants Pediatrics Neonates 2 Pulse Rate Accuracy5 Pulse rate 25 240...

Page 64: ...mperature 41 F to 104 F 5 C to 40 C Transport Storage Temperature 40 F to 158 F 40 C to 70 C 9 Operating Humidity 5 to 95 non condensing Operating Altitude 500 mbar to 1060 mbar pressure 1000 ft to 18...

Page 65: ...iance 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 T...

Page 66: ...0 breaths per minute in bench top testing Clinical validation for up to 30 breaths per minute was also performed with the Masimo Acoustic Respiration sensor and instrument 8 This represents approximat...

Page 67: ...The nurse call feature on the Radical 7R Pulse CO Oximeter 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...

Page 68: ...Y CAN RESULT TO AVOID DAMAGE TO THE CABLES ALWAYS HOLD THE CABLE BY THE CONNECTOR RATHER THAN THE CABLE WHEN CONNECTING OR DISCONNECTING EITHER END SELECTING A MASIMO SET SENSOR When selecting a senso...

Page 69: ...le RA 125 MASIMO RAINBOW SENSORS Masimo Rainbow sensors must be used for the Radical 7R Pulse CO Oximeter parameters to enable measurement of Oxyhemoglobin SpO2 Carboxyhemoglobin SpCO Methemoglobin Sp...

Page 70: ...LNOPv and LNCS SpO2 sensors when used with Red PC or Red LNC Patient Cables respectively Select the appropriate patient cable to attach the LNOP or LNCS sensor to the instrument ReSposable Pulse CO Ox...

Page 71: ...95 TF I LNOP Adhesive Sensors LNOP sensors must be used in conjunction with Red PC cables Adt Adtx Pdt Pdtx Inf Neo NeoPt LNOPv TM Adhesive Sensors LNOPv sensors must be used in conjunction with Red P...

Page 72: ...TF I M a s i m o S e n s o r s c o n t i n u e d M LNCS LNCS Adhesive Sensors LNCS sensors must be used in conjunction with Red LNC cables Adtx Pdtx Inf Neo NeoPt NeoPt 500 M LNCS LNCS Specialty Senso...

Page 73: ...ENT OF A SINGLE USE ACOUSTIC RESPIRATION SENSOR A single use Acoustic Respiration sensor may be reapplied to the same patient if it is dry clean free of debris and oil and the adhesive still adheres t...

Page 74: ...Rainbow SET Radical 7R Pulse CO Oximeter can be cleaned with a soft cloth dampened with a mild detergent and warm water solution Do not allow liquids to enter the interior of the instrument The outer...

Page 75: ...t turned off CAUTIONS ALL BATTERIES LOSE CAPACITY WITH AGE THUS THE AMOUNT OF RUN TIME LEFT AT LOW BATTERY WILL VARY DEPENDING UPON THE AGE OF THE BATTERY AT LOW BATTERY CONNECT THE RADICAL 7R PULSE C...

Page 76: ...battery make sure the AC power cord is removed and power to the Pulse CO Oximeter is turned off To replace the Handheld battery follow these instructions 1 Turn the Radical 7R Pulse CO Oximeter Handhe...

Page 77: ...low shortly after replacement the instrument requires service WARNING FIRE HAZARD TO PROTECT AGAINST FIRE HAZARD REPLACE ONLY WITH FUSES OF THE SAME TYPE CURRENT RATING AND VOLTAGE RATING P e r f o r...

Page 78: ...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 2 Connect the common lead of a digital multi meter to the p...

Page 79: ...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 the equipment is fully dry bef...

Page 80: ...to the following shipping address For USA Canada Asia Pacific For Europe All other locations Masimo Corporation 40 Parker Irvine California 92618 949 297 7000 FAX 949 297 7001 Masimo International S...

Page 81: ...ed because of a modification of the Product or Software without Masimo s written authorization b supplies instruments or electrical work external to the Product or not manufactured by Masimo c disasse...

Page 82: ...h translate release distribute copies of modify adapt translate reverse engineer decompile disassemble or create derivative works based on the Software or the written materials 3 Transfer Restrictions...

Page 83: ...eived from Masimo and no license is granted to have Masimo s sensors reprocessed or otherwise modified unless specifically authorized by Masimo There is no license implied or otherwise that would allo...

Page 84: ...TION 2386 REPLACEMENT BATTERY RADICAL 7R HANDHELD 1317 RADICAL 7R POLE CLAMP 2350 RADICAL 7R HANDHELD LOCK 2351 RADICAL 7R HANDHELD LOCK KEY 2368 MASIMO SET TESTER 20 PIN 1584 RADICAL 7R POWER CORD LO...

Page 85: ...www masimo com Instruments and sensors containing Masimo Rainbow SET technology are identified with the Masimo Rainbow SET logo 33975 6189A 1209...

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