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Expression MR200 MRI Patient Monitoring System INSTRUCTIONS FOR USE Revision B English
*989803184961*
989803184961 Manufacturer Copyright Invivo,adivisionofPhilipsMedicalSystems 12151ResearchParkway Orlando,FL32826 USA 8774684861
+31(0)499378299 www.invivocorp.com Copyright2013,KoninklijkePhilipsN.V. Allrightsreserved. REF989803184961Rev.B,October2013 PrintedinUSA Proprietary Information Thisdocumentandtheinformationcontainedinitisproprietaryandconfidential informationofKoninklijkePhilipsN.V. andmaynotbereproduced,copiedinwholeorin part,adapted,modified,disclosedtoothers,ordisseminatedwithoutthepriorwritten permissionoftheKoninklijkePhilipsN.V.Thisdocumentisintendedtobeusedbycustomers andislicensedtothemaspartoftheirKoninklijkePhilipsN.V. equipmentpurchase.Useof thisdocumentbyunauthorizedpersonsisstrictlyprohibited. KoninklijkePhilipsN.V. providesthisdocumentwithoutwarrantyofanykind,impliedor expressed,including,butnotlimitedto,theimpliedwarrantiesofmerchantabilityand fitnessforaparticularpurpose. KoninklijkePhilipsN.V. hastakencaretoensuretheaccuracyofthisdocument.However, KoninklijkePhilipsN.V. assumesnoliabilityforerrorsoromissionsandreservestherightto makechangeswithoutfurthernoticetoanyproductshereintoimprovereliability,function, ordesign.KoninklijkePhilipsN.V. maymakeimprovementsorchangesintheproductsor programsdescribedinthisdocumentatanytime. Neweditionsofthisdocumentwillincorporateallmaterialupdatedsincetheprevious edition.Updatepackagesmaybeissuedbetweeneditionsandcontainreplacementand additionalpagestobemergedbyarevisiondateatthebottomofthepage.Notethatpages whicharerearrangedduetochangesonapreviouspagearenotconsideredrevised. Thedocumentationpartnumberandrevisionindicatethecurrentedition.Theprintingdate changeswhenanewrevisionisprinted.(Minorcorrectionsandupdateswhichare incorporatedatreprintdonotcausethedatetochange.)Thedocumentrevisionletter changeswhenextensivetechnicalchangesareincorporated. ii Contents Manufacturer . 1-ii Copyright . 1-ii Proprietary Information . 1-ii Chapter 1: Important Information Intended Audience . 1-1 Indications for Use . 1-2 Conventions . 1-2 System Conventions. 1-2 Document Conventions . 1-3 Warnings . 1-3 Cautions. 1-3 Notes . 1-3 Contraindications . 1-4 Safety. 1-5 Equipment Classification (According to IEC 60601-1) . 1-5 Electromagnetic Compatibility (EMC). 1-5 Radios . 1-5 Using Batteries Safely . 1-9 List of Symbols. 1-10 Examining the Contents. 1-15 Assembly . 1-16 Disposing of the Packaging . 1-16 Rear Panel Connections. 1-16 Replacing Cart Batteries. 1-17 Connecting AC Mains Power. 1-18 MR200 Battery Operation . 1-19 Attaching the SPO2 Sensor to the wSPO2 Module . 1-20 Charging Module Batteries. 1-20 Replacing a Module Battery . 1-20 Assigning the Network Channel of a Module . 1-21 Changing the Network Channel of a Module. 1-22 Advanced User Options . 1-24 Expression Information Portal (Model IP5) . 1-24 Additional Options . 1-25 Accessory List . 1-25 Chapter 2: System Overview System Components . 2-1 Use Model . 2-1 Acquisition and Control . 2-2 Synchronization . 2-2 Device Control . 2-3 Cart . 2-3 Speaker . 2-4 Storage Basket. 2-4 Module Holders . 2-5 Wireless Processing Unit . 2-5 Contents 1 Rear Panel . 2-5 Wheel Locks . 2-5 Battery Compartments . 2-5 Guide Handles . 2-5 Patient Connection Panel . 2-6 Display and Control Assembly . 2-6 Positioning the MR200. 2-6 Wireless Modules. 2-7 wECG Module. 2-8 wSPO2 Module. 2-8 Module Status Indicator . 2-8 System Power-Up and Communications Verification . 2-9 System Parameters . 2-10 Display Panel. 2-10 Power Switch . 2-11 Keypad . 2-11 Control Knob. 2-12 Status Indicator. 2-12 LCD. 2-13 Display Areas. 2-13 Informational Area . 2-14 Vital Sign Boxes Area . 2-14 No Data Available Indication . 2-15 Communication and Power Status Display Area . 2-16 Vital Sign Traces Area . 2-17 Modes of Operation . 2-18 Normal Mode . 2-18 Suspend Mode . 2-18 Simulation Mode . 2-19 Chapter 3: Getting Started Monitor Initialization . 3-1 Initial Alarm Setting Indication. 3-1 SETUP Menu. 3-2 MONITOR Menu. 3-3 RECALL SETUPS . 3-4 STORE SETUPS . 3-5 PARAMETER SELECTION . 3-7 SOUND ADJUST . 3-8 PATIENT . 3-10 PEDIATRIC ECG . 3-11 SET TIME. 3-12 DEFAULT SETUPS . 3-13 SWEEP SPEED. 3-14 RESP SPEED . 3-14 NETWORK. 3-15 SERVICE(BIO-MED) . 3-16 2 Contents Chapter 4: Monitoring ECG wECG Module and Lead Cable . 4-1 Defibrillator Use . 4-2 Patient Preparation for ECG Monitoring. 4-3 ECG Site Considerations . 4-3 ECG Quadtrode Electrode Types. 4-3 Selecting the Quadtrode Electrode and ECG Lead Cable. 4-4 Selecting the Quadtrode Electrode Placement Site. 4-4 Preparing the ECG Site . 4-7 Checking Electrode Contact Quality . 4-7 Attaching the Lead Cable . 4-8 Lead Failure Indication . 4-10 Positioning the wECG Module and Lead Cable for Scanning . 4-11 Minimizing the Risk of MRI-Related Heating . 4-12 Checking the ECG Signal Strength . 4-13 Selecting the Scale . 4-13 Changing the Lead View . 4-14 Selecting the Filter Mode. 4-15 ECG Waveforms and VS Box . 4-16 Changing the Waveform Speed . 4-17 Changing the Heart Rate Alarm Limits. 4-17 ECG Menu . 4-18 ALARM LIMITS . 4-19 TRACE A LEAD. 4-20 TRACE B LEAD. 4-20 SCALE. 4-21 GATING SOURCE. 4-21 HR SOURCE . 4-22 HR TONE SOURCE . 4-22 FILTER MODE. 4-23 ECG TEST SIGNAL. 4-24 T-WAVE SUPPRESSION . 4-25 MAGNET CONTROL. 4-25 Using the Gating Feature. 4-26 Using ECG Gating . 4-26 Using SPO2 Gating . 4-27 Chapter 5: Monitoring SPO2 wSPO2 Module, Sensor and Attachment. 5-1 Patient Preparation for SPO2 Monitoring. 5-2 Selecting the Site and Attachment . 5-2 Attaching the Clip or Grip to the SPO2 Sensor . 5-2 Applying the SPO2 Attachment to the Patient . 5-3 Positioning the wSPO2 Module for Scanning. 5-5 SPO2 Waveform and VS Box . 5-7 Changing the Waveform Speed . 5-7 Changing the SPO2 Waveform Amplitude . 5-8 Changing the SPO2 Alarm Limits. 5-8 Assessing Suspicious SPO2 Readings . 5-9 Contents 3 SPO2 Menu . 5-9 ALARM LIMITS . 5-10 SIZE . 5-11 AVERAGING TIME . 5-11 GATING SOURCE. 5-12 HR SOURCE . 5-12 HR TONE SOURCE. 5-13 Chapter 6: Monitoring NiBP Patient Preparation for NiBP Monitoring . 6-2 Selecting the NiBP Cuff . 6-3 Positioning the NiBP Cuff . 6-4 Connecting the NiBP Cuff . 6-4 Choosing the Measurement Mode . 6-5 Selecting Auto Mode . 6-5 Making Manual Measurements . 6-6 Initial Inflation Pressures and Reading Durations. 6-6 Stopping an NiBP Measurement. 6-7 NiBP VS Box . 6-7 Systolic/Diastolic Format. 6-7 Mean Format. 6-8 Changing the NiBP Alarm Limits. 6-9 Changing the Unit of Measure . 6-10 NiBP Menu. 6-11 ALARM LIMITS . 6-12 INTERVAL . 6-12 AUTO MODE . 6-13 HISTORY . 6-13 FORMAT . 6-14 Chapter 7: Monitoring CO2 Patient Preparation for CO2 Monitoring. 7-1 Selecting the CO2 Accessory . 7-1 Connecting the Sampling Line . 7-2 Applying the Sampling Line to the Patient . 7-3 CO2 Waveform and VS Box . 7-5 Changing the Waveform Speed . 7-5 Changing the CO2 Alarm Limits . 7-6 Changing the Unit of Measure . 7-7 CO2 Menu . 7-7 ALARM LIMITS . 7-8 SIZE . 7-9 GRIDS . 7-9 ZERO CAL . 7-10 UNIT. 7-10 4 Contents Chapter 8: Monitoring RESP Patient Preparation for RESP Monitoring. 8-1 Monitoring Respiration using CO2 . 8-1 Monitoring Respiration using the Bellows. 8-1 Bellows Preparation . 8-2 Respiration VS Box . 8-3 Changing RESP Alarm Limits. 8-4 RESP Menu . 8-5 ALARM LIMITS . 8-5 SOURCE . 8-6 Chapter 9: Alarms Alarm Indications . 9-1 Alarm Safety Information . 9-1 Status and Technical Alarms . 9-1 Physiological Alarms . 9-2 Enabling Print on Alarm . 9-2 Controlling Alarm Indications . 9-3 Latched and Unlatched Alarms . 9-3 Showing or Hiding Current Alarm Limits. 9-3 Setting Alarm Limits . 9-4 Setting Alarm Limits Globally. 9-4 Setting Alarm Limits Individually . 9-5 Restoring Default Alarm Limit Settings . 9-6 Controlling the Alarm Sound. 9-7 Adjusting the Alarm Volume . 9-7 Silencing the Alarm . 9-7 Alarm Hold Mode. 9-8 ALARMS Menu. 9-8 SET INDIVIDUAL. 9-10 CALCULATE ALL . 9-10 UPPER WINDOW . 9-11 LOWER WINDOW. 9-11 ALARM SOUND . 9-12 DEFAULT LIMITS . 9-12 TYPE . 9-13 LIMITS DISPLAY. 9-13 Testing Alarms . 9-13 Adjustable Alarm Limit Ranges . 9-14 Alarm Limit Defaults. 9-15 Listing of Alarms. 9-16 Status and Technical Alarm Indications and Messages. 9-16 Physiological Alarm Indications and Messages . 9-23 Chapter 10: Trend Data and Printing Trend Data . 10-1 Tabular Trend Data . 10-1 Viewing Multi-Parameter Tabular Trend Data . 10-2 Contents 5 Graphical Trend Data . 10-2 Viewing Individual Trend Graphical Data . 10-3 Viewing Multi Trend Graphical Data . 10-4 HISTORY Menu . 10-5 PREV PAGE . 10-6 NEXT PAGE. 10-6 CLEAR ALL . 10-6 MULTI TRENDS. 10-7 TREND ARROWS . 10-8 ARROW PERIOD. 10-8 Print Functions. 10-9 PRINTER Menu . 10-9 TRACE 1 . 10-11 TRACE 2 . 10-12 TRACE DELAY . 10-12 Chapter 11: Cleaning and Maintenance Environmental Requirements. 11-1 General Cleaning Guidelines. 11-1 Cleaning the Cart and Modules . 11-2 Sterilizing the Cart and Wireless Modules . 11-4 Cleaning the Accessories . 11-4 Sterilizing the Accessories . 11-5 Inspecting the Accessories for Damage . 11-6 Storing the Accessories . 11-6 Final Disposal . 11-6 Disposal of the Device and Accessories. 11-7 Disposing of Batteries . 11-7 Maintenance . 11-8 Testing CO2 Accuracy . 11-8 Testing the NiBP System . 11-8 Default Initialization. 11-10 Updating Software . 11-10 SERVICE(BIO-MED) Menu . 11-12 S/W REV . 11-13 SIMULATION MODE . 11-14 NiBP TESTS . 11-14 GAS CAL . 11-14 SERVICE UTILITIES . 11-15 SYSTEM CONFIG . 11-15 Repair . 11-16 Passing This Product on to Another User . 11-17 Packaging the MR200 . 11-18 Appendix A: Specifications General . A-1 Patient Safety . A-1 Power Requirements, Cart . A-2 6 Contents Battery . A-2 Environment . A-3 Dimensions and Weights . A-3 Liquid Crystal Display. A-3 Displayed Parameters . A-4 ECG . A-4 ECG Amplifier. A-4 Heart Rate . A-4 Cardiotach . A-4 Alarm Limits (HR) . A-5 Test/Calibrations. A-5 ECG Supplemental Information, as required by IEC 60601-2-27. A-5 Pulse Oximeter. A-6 Alarm Limits . A-6 Non-Invasive Blood Pressure. A-7 General. A-7 Pneumatic Systems . A-7 Measurement Range . A-7 Accuracy. A-7 Alarm Limits . A-8 Modes. A-8 CO2 (Optional). A-9 Alarm Limits . A-10 Bellows Respiration . A-11 Gating Connector . A-11 Appendix B: Warranty Warranty Statement . B-1 Appendix C: Regulatory Information European Union . C-1 Declaration of Conformity. C-1 Authorized Representative . C-1 Australia . C-1 Appendix D: Guidelines and References Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic Reso-
nance Procedures . D-1 References. D-3 Notes Contents 7 8 Contents CHAPTER 1 Important Information ImportantuserinformationabouttheExpressionMR200MRIPatientMonitoringSystemand contactinformationforRoyalPhilipsisdiscussedhere. Informationregardingthesafety,accessories,assemblyandoperationofafullyequipped ExpressionMR200MRIPatientMonitoringSystemcanbefoundinthisdocument.Some informationmaydepictmonitoringfeaturesnotpresentonyourMR200.Forinformationabout allfeaturesandenhancements,contactusoryoursalesrepresentative:
Invivo Orlando,FL32826 U.S.A. 8774684861 www.invivocorp.com Foradditionalinformationaboutyouraccessories,pleaseconsultthedocumentationthat accompaniestheaccessory. Thisproductwillperforminconformitywiththedescriptioncontainedinthismanualand accompanyinglabelingwhenassembled,operated,maintainedandrepairedinaccordancewith theinstructionsprovided. Thisdevicemustbecheckedandcalibratedperiodically.Amalfunctioningdevicemustnotbe used.Partsthatarebroken,missing,plainlyworn,distorted,orcontaminatedmustbereplaced immediately.Referthedevicetoqualifiedservicepersonnelforrepairorreplacement.This deviceoranyofitspartsmustnotberepairedotherthaninaccordancewithwritteninstructions providedbythemanufacturer.ThedeviceshallnotbealteredwithoutwrittenapprovalofRoyal Philips.Theuserhasthesoleresponsibilityforanymalfunctionwhichresultsfromimproperuse, faultymaintenance,improperrepair,damageoralterationbyanyoneotherthanauthorized servicepersonnel. NOTE Laws in the United States restrict sale of this device on the order of a physician. Intended Audience ThisInstructionsforUse(IFU)manualfortheExpressionMR200MRIPatientMonitoringSystem isintendedforusebyhealthcareprofessionalstrainedintheuseoftheequipmentandvitalsigns monitoring. ExpressionMR200InstructionsforUseImportantInformation11 Indications for Use TheExpressionMR200MRIPatientMonitoringSystemisintendedforusebyhealthcare professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals forsynchronizationoftheMRIscanner.TheExpressionMR200providesmonitoringforthe followingvitalsignparameters:ECG,pulseoximetry(SpO2),noninvasivebloodpressure(NiBP), and(optional)carbondioxide(CO2). NOTE The Expression MR200 is intended to be used to monitor the vital signs of a patient in an MR magnet room. This system is not intended for use on a patient being transported outside of a health care facility. Conventions CertainconventionsareusedthroughouttheExpressionMR200MRIPatientMonitoringSystem tospeeduseandfamiliaritywiththedevice.Thisaccompanyinguserinformationalsouses documentconventionstoassistyouinfindingandunderstandinginformation. System Conventions Thefollowingsystemconventionsareused:
Thedisplaypanelincludesacontrolknobandakeypad. Pressakeytoactivateordeactivateitsfunctionortoviewitsmenu. Turnandpressthecontrolknobtonavigateandselectmenuoptions,submenus, itemsorvalues. AllmenuscontainaRETURNoptionthatclosestheopenmenu. Mostmenusemployatimeoutfeaturewhere,ifnoactionistakenforapproximately60 seconds,anopenmenuwillautomaticallyclose. Toprotectagainstaccidentalchanges,aYES/NOpromptisassociatedwithsomemenu options.Whendisplayed,youmustanswerthisprompt;otherwise,adelayof approximately60secondswillbeequivalenttoselectingNO(thiscanalsobeaccomplished bypressingtheMainkey.) Toprotectagainstunauthorizedchanges,somemenuitemsfeaturepasswordprotection. Youmustenterthecorrectnumericcodeforaccessandadelayofapproximately60 secondsisequivalenttomakingnoentry. 12ImportantInformationExpressionMR200InstructionsforUse Document Conventions Thesedocumentconventionsareused:
TheExpressionMR200MRIPatientMonitoringSystemwillhereafterbereferredtoasthe MR200. Allproceduresarenumberedandanysubstepsarelettered.Completethestepsinthe sequencepresentedtoensuresuccess.Proceduresareindicatedbythefollowingtable:
Step Action 1 2 3 Unlessnoted,allproceduresstartfromthenormalmodeofoperation. Controlnames,menuitems,vitalsignreferences,etc.,arespelledastheyappearinthe MR200. Bulletedlistsindicategeneralinformationaboutaparticularmenufunctionorprocedure, anddonotimplysequentialorderoroperation. Messagesregardingaconditionorsysteminformationaregiveninbolduppercaseletters. TheleftsideoftheMR200isonyourleftasyoustandinfrontofthesystem,facingit.The frontoftheMR200isnearestyouasyouoperateit. Thefrontofthemoduleisnearestyouasyouoperateit. Warnings Cautions Notes Warning WARNING Warnings provide information you should know to avoid injuring yourself, patients or personnel. CAUTION Cautions provide information you should know to avoid damaging the equipment and software. NOTE Notes provide additional information you should know regarding usage. ExpressionMR200InstructionsforUseImportantInformation13 Contraindications Refertoallwarnings.BeforeusingtheMR200,readthewarningsandthesafetyinformation below.ThewarningsbelowrefertotheMR200initsentirety. WARNINGS Only use only supplied power cords and connect to properly grounded AC outlets to Thoroughly read and understand these Instructions for Use prior to use of the MR200. A shock hazard exists if the MR200 is operated without the covers installed. avoid electrical shock. Ensure that the monitor settings are appropriate for the patient being monitored. The patient must remain calm and motionless while the MR200 is being used. If the patient is overactive, prolonged or inaccurate readings may result. Position of the accessories may affect measurement accuracy. Always consult a physician for interpretation of measurements provided by the MR200. Perform operational verification prior to use. If the MR200 fails to function properly, remove it from use and contact technical support personnel. Screen all patients for metallic wires, implants, stents, etc. prior to MR procedures. These electrical conductors will react with the MR environment or with the accessory
(if applied directly over the conductor), thus increasing the risk of heating. 14ImportantInformationExpressionMR200InstructionsforUse Safety Equipment Classification (According to IEC 60601-1) Class I equipment Type CF (defibrillator-proof) equipment According to the type of protection against electrical shock:
According to the degree of protection against electrical shock:
According to the degree of protection against harmful ingress of water:
According to the methods of sterilization or disinfection:
According to the mode of operation:
Equipment not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. IPX0 (ordinary) protection against ingress of fluids Non-sterilizable; use of liquid surface disinfectants only Continuous operation CAUTION To minimize risk of damage to the monitor during defibrillation use only approved supplies. Electromagnetic Compatibility (EMC) Thedeviceisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Giventhe deviceselectromagneticemissionsandimmunitycharacteristics,thecustomerorusershould assurethatthedeviceisusedwithinsuchanenvironment.Thefollowinginformationis mandatedbyIEC6060112,theinternationalstandardfortheelectromagneticcompatibility
(EMC)ofmedicalelectricalequipment. Radios FrequencyRange:2401.72469.8MHz ModulationType:GFSK WPUEIRP:4.2dBm(peak) wECGandwSPO2EIRP:0dBm(peak) ExpressionMR200InstructionsforUseImportantInformation15 WARNINGS Operation of the MR200 outside the specifications indicated in Appendix A will cause inaccurate results. The use of portable and mobile radio-frequency (RF) communications equipment can affect the operation of this device. The use of accessories, transducers and cables other than those specified in the accessory list accompanying these instructions for use (with the exception of transducers and cables sold by Invivo (Royal Philips) for the equipment or system as replacement parts for internal components) will result in increased emissions or decreased immunity of the equipment or system. The MR200 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system must be observed to ensure normal operation in the configuration in which it will be used. The MR200 needs to be installed and put into service according to the EMC information provided in the instructions for use. Portable and mobile RF communications equipment can affect medical electrical equipment. The MR200 may be interfered with by other equipment with CISPR emission requirements. Guidance and Manufacturers Declaration - Electromagnetic Emissions The MR200 is intended for use in the electromagnetic environment specified below, and the customer or the user should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/flicker emissions IEC 61000-3-3 Group 1 Class B Class B Complies The MR200 uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The MR200 is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 16ImportantInformationExpressionMR200InstructionsforUse Guidance and Manufacturers Declaration - Electromagnetic Immunity The MR200 is intended for use in the electromagnetic environment specified below. The customer or the user of the MR200 should assure that it is used in such an environment. Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 IEC 60601 Test Level Compliance Level 6kV contact 8kV air 6kV contact 8kV air 2kV for power supply lines 2kV for power supply lines 1kV for input/output lines 1kV for input/output lines Surge IEC 61000-4-5 1kV differential mode 2kV common mode 1kV differential mode 2kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
< 5% Ut
(> 95% dip in Ut) for 0.5 cycle
< 5% Ut
(> 95% dip in Ut) for 0.5 cycle 40% Ut
(60% dip in Ut) for 5 cycles 40% Ut
(60% dip in Ut) for 5 cycles 70% Ut
(30% dip in Ut) for 25 cycles 70% Ut
(30% dip in Ut) for 25 cycles
< 5% Ut
(> 95% dip in Ut) for 5 seconds
< 5% Ut
(> 95% dip in Ut) for 5 seconds 3 A/m 3 A/m Power frequency (50/
60 Hz) magnetic field IEC 61000-4-8 Electromagnetic Environment - Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the MR200 requires continued operation during AC power interruptions, power from an uninterruptable power supply or battery is recommended. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE Ut is the AC mains voltage prior to application of the test level. ExpressionMR200InstructionsforUseImportantInformation17 Guidance and Manufacturers Declaration - Electromagnetic Immunity The MR200 is intended for use in the electromagnetic environment specified below. The customer or the user of the MR200 should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF IEC 61000-4-6 3 Vrms 150 KHz to 80 MHz V1 = 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz E1 = 3 V/m Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should not be used no closer to any part of the MR200, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = (3.5/V1) P P d = (3.5/E1)
(80 MHz to 800 MHz) d = (7/E1)
(800 MHz to 2.5 GHz) P Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom-
mended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the symbol. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MR200 is used exceeds the applicable RF compliance level above, the MR200 should be observed to ensure normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the MR200. b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. 18ImportantInformationExpressionMR200InstructionsforUse Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the MR200 The MR200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MR200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MR200 as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power Of Transmitter
(W) Separation Distance According To Frequency Of Transmitter (m) 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = (3.5/V1) P d = (3.5/E1) P d = (7/E1) P 0.01 0.1 1 10 100 0.117 0.369 1.167 3.689 11.667 0.117 0.369 1.167 3.689 11.667 0.233 0.738 2.333 7.379 23.333 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Using Batteries Safely Batterieshavelifecycles.Whentheequipmentoperatingtimeprovidedbybatterypower becomesmuchshorterthanusual,thebatterylifeisatanend.Immediatelyremoveanybattery thathasanexpiredlifecycleandreplaceitwithanewbatteryofthesametype.(Refertopage1 28forpartnumbers.)Toensurethesafetyofoperatorsandpatients,observethefollowing warningsandcautions. Warning WARNING Stop using any battery that exhibits abnormal heat, odor, color, deformation, or other condition. If a battery is punctured or if battery liquid leaks onto your skin or clothing, immediately wash the area and clothing with fresh water. If battery liquid gets into your eyes, do not rub your eyes; immediately flush your eyes with clean water and consult a physician. ExpressionMR200InstructionsforUseImportantInformation19 Caution CAUTIONS If the battery contacts become dirty, wipe them clean with a dry cloth before use. Store batteries in a dry place, between 0C to 40C. Keep metal objects away from the battery contacts. List of Symbols ThesymbolsinthefollowingtablemayappearontheMR200,thepackingmaterials,orinthis manual. Symbol Meaning Symbol Meaning CSA certified for both the U.S. and Canadian markets Underwriters Laboratories Component Recognition Mark for both the U.S. and Canadian markets Korean Communications Commission radio certification MR Conditional: Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety. MR Conditional: Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety. Federal Communications Commission radio certification Taiwan National Communications Commission certification Conforms to the Medical Device Directive Conforms to the R&TTE Directive (Radio &
Telecommunications Terminal Equipment) MR unsafe 110ImportantInformationExpressionMR200InstructionsforUse Symbol Meaning Symbol Meaning Warning! Specific warnings associated with the devices that are not otherwise found on the label; when located on the wECG module connector, indicates that only specified ECG cables shall be used to ensure safe use in the MR and defibrillation protection. MR safe Consult the Instructions for Use Do not adjust without referring to the service manual Use by date (do not use after the year, month or day shown) Authorized representative in the European Community Catalog, reorder or reference part number Alternating current Infant Caution! Specific warnings or precautions associated with the devices that are not otherwise found on the label MR safe Mandatory action: Follow the Instructions for Use Single use only, disposable one-time-use product; do not reuse Defibrillator-proof type CF equipment (IEC 60601-1) protection against shock Serial number Batch code/lot number Direct current Neonate Adult / Pediatric ExpressionMR200InstructionsforUseImportantInformation111 Symbol Meaning Symbol Meaning Toe site Finger site Toe site Thumb site Foot site Temperature range Prescription only NiBP cuff, wrong side out NiBP cuff, correct side out NiBP cuff circumference range Weight Keep dry Humidity range Atmospheric pressure limitation Fragile Patient Up ECG 112ImportantInformationExpressionMR200InstructionsforUse Symbol Meaning Symbol Meaning Non-invasive blood pressure
(NiBP) Contains no latex Universal Serial Bus (USB) Dispose of the battery or electronic waste in accordance with your countrys requirements Non-ionizing radiation Pneumatic respiration Cardiac gating output Input connection Manufacturer name and address information Conforms to the RoHS directive Date of manufacture, YYYY-
MM Battery Non-magnetic part Wheel lock, press to engage Do not move the MR200 inside the 1,500 gauss field line of the MR magnet or within 1.5 m (4.9 feet), whichever is greater, as measured from the center line of the bore. Apply wheel locks and do not move the MR200 inside the 1,500 gauss field line of the MR magnet or within 1.5 m
(4.9 feet), whichever is greater, as measured from the center line of the bore. Main key NiBP key mp Trends key ExpressionMR200InstructionsforUseImportantInformation113 Symbol Meaning Symbol Meaning Print key Silence key Alarm sound on Alarm sound on hold Patient key Setup key Suspend key Power switch Alarm sound silenced Alarm sound off Current setups have changed Heartbeat detected On AC power wECG battery time remaining wSPO2 battery time remaining No MR200 communication with the wECG module Network channel A Breathing effort detected Good battery power No AC, on battery power Low battery power No MR200 communication with the wSPO2 module Network channel B Network channel C 114ImportantInformationExpressionMR200InstructionsforUse Symbol Meaning Symbol Meaning Network channel D Network channel E Cart connected to AC mains, batteries installed Printer ready Cart connected to AC mains, batteries not installed Printing in progress and time remaining, in seconds No printer available Printer not ready Examining the Contents Toreportshippingdamage,ortoresolveanyissuesorconcernswithyourorder,contact CustomerService.(Saveallpackingmaterialsandrelatedshippingdocuments,asthesemaybe requiredtoprocessashippingdamageclaimwiththecarrier.) Afterremovingthecontentsfromtheshippingcontainers,carefullyexamineallitemsforsignsof damagethatmayhaveoccurredduringshipment.Also,checkallitemsagainsttheincluded packinglistandthepurchaserequest. Thecontentsofthecrateshouldinclude:
Twocartbatteries InstructionsForUse(IFU)manual MR200 QuickReferenceGuide PowerCord Aseparatecontainercouldincludeadditionalitems:
WirelessECGmodule WirelessSPO2module Modulebatterycharger Modulebatteries ExpressionMR200InstructionsforUseImportantInformation115 Assembly Thissectionprovidesimportantinformationaboutassemblyandsystemrequirements.Observe thewarningsandcautionsthatappearthroughoutthismanualwhenassemblingandusingthe MR200.Forthelocationofcartcomponentsnotdetailedbelow,seetheillustrationonpage23. Warning WARNING Only perform assembly of the MR200 at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury. CAUTION The MR200 and accessories must be used and stored according to the environmental specifications detailed in Appendix A. Failure to adhere to the specified environmental requirements may affect system and/or accessory performance and accuracy. Disposing of the Packaging Thepackagingcanberetainedforfutureuse.Otherwise,thepackagingforthesystem(whichis madeofrecyclablematerialsthatincludecorrugatedpaper,polyethylene[PE]foamandplastic) maybesubjecttodisposalregulationsforuserandenvironmentalsafety.Fordisposal,itmaybe necessarytoseparatethesematerialsbytype.Alwaysobserveandadheretoyourcurrentlocal regulationswhendisposingofthepackagingmaterial. Rear Panel Connections Hardwareinterfaceandpowerconnectionsareprovidedontherearpanelofthecart. Gatingconnector Presentsoutputsforgatingconnections totheMRsystem.Removetheshield capfromthegatingconnectorthen installagatingcable.(Cablesaretype dependant;seepage126.) USBport AllowsUSBthumbdriveconnectionsfor MR200softwareupdatesonly.(See UpdatingSoftwareonpage1110.) Gating connector USB port AC inlet Strain relief 116ImportantInformationExpressionMR200InstructionsforUse ACInlet IstheinputconnectionforACvoltagetothecart. Strainrelief SecurestheACpowercordtothecart. Caution CAUTIONS When making connections to the rear panel of the MR200, ensure that the final installation complies with IEC/EN 60601-1-1, General Requirements for the Safety of Medical Electrical Systems, to assure operator and patient safety. Always check the summation of leakage currents when the MR200 is connected to additional external equipment. Where the integrity of the external protective conductor in the installation or its arrangement is in doubt, the MR200 shall be operated from batteries. Replacing Cart Batteries Warning WARNING Cart batteries contain ferrous materials that are attracted to the MR magnetic field. Do not install or remove the cart batteries when closer than the 1,000 gauss (0.1 T) field line, as measured from the center line of the MR bore to the MR200. The batteries will be attracted to the magnetic field, possibly causing patient or user injury. CAUTION Never force a battery into a battery compartment as it will damage the battery and/or the cart. Cartbatterieswillslideandlatchinto placeinthebatterycompartmentsin thebaseoftheunit:
Wheninstallingbatteriesthey mustbeorientedproperly,as thebatteryshapeisdesignedto fitthecontourofthebattery compartment. Ifthebatterydoesnotlatch intoplacewhenfullyinsertedin thebatterycompartment,then itisnotproperlyoriented.In thiscase,removeandreorient thebatterythenreinsertitintothebatterycompartment. Battery compartments Cart batteries ExpressionMR200InstructionsforUseImportantInformation117 Toinstallcartbatteries Orientabatteryforinsertion(labelsidedown,connectorfacingforward)thenslideitintoa batterycompartment.Whenproperlyinserted,thebatterywilllatchintoplace.Aclickwillbe heardandthebatterywillbeflushwiththefaceofthebatterycompartment.Repeattheprocess fortheremainingbattery. NOTE Before initial use, charge the batteries for at least 12 hours with the MR200 turned off and connected to AC mains power. Toremoveacartbattery Pressthebatteryeject button(locatedonthe undersideofthebattery compartment).
(Ifthebatterydoesnot release,applyaslight forwardpressureonthe batterywhilepressingthe ejectbutton.) Repeattheprocessto removetheremaining battery. Connecting AC Mains Power Cart batteries Battery eject buttons CAUTION Avoid use of electrical extension cords or multiple portable socket outlets, which may create a safety hazard by compromising the grounding integrity of the MR200. ToconnectACmainspower Step 1 2 3 4 Action Ensurethatthecartbatteriesareinstalled;seepage118for details. PositiontheMR200;seepage26. Raisethestrainrelief. ConnecttheACpowercordtotheACinletontheMR200.For addedmobility,thepowercordextension(REF989803168221)can alsobeconnected. 118ImportantInformationExpressionMR200InstructionsforUse Step 5 6 Action LowerthestrainreliefovertheACpowercord. ConnecttheACpowercordtoanapprovedACmainsoutlet. ToremovetheMR200fromACmainspower PullouttheplugatthewalloutletandthenremovetheACpowercordfromtheMR200.Store thecordinasafeplace. MR200 Battery Operation Warning WARNING Do not touch the internal battery compartments of the cart and the patient simultaneously. Cartbatteriesarechargedandconditionedbyanintegratedintelligentchargingsystem.When turnedon,theMR200operatesfromACpowerandsimultaneouslychargesthebatteries.When connectedtoACpowerandturnedoff,thebatterychargerremainsfunctionalandcharging occursautomatically.IfACvoltageislost,theMR200willautomaticallyswitchtobatterypower toprovideuninterruptedservice. NOTES To prevent unintentional power interruptions, its highly recommended to always keep the batteries inserted in the MR200 even when operating on AC power. If the MR200 will not be used for more than 3 days, remove the batteries or keep AC power connected. MaximumMR200operationtimeunderbatterypoweris approximately8hours,butthismaybereducedbyupto2 hourswhencertainoperationsareperformedsuchasrunning NiBPcyclesatlessthan5minuteintervals. Visualindicationofthechargedcapacityisdisplayedbythe cartstatusicon(seepage216). Chargedcapacitycanalsobeseenbypressingthepowerlevel buttononeachcartbattery,wherethecapacityisindicatedin 20percentincrements. Power level button Cart battery ExpressionMR200InstructionsforUseImportantInformation119 Attaching the SPO2 Sensor to the wSPO2 Module WARNINGS Only perform this assembly at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury. Connecting other than specified SPO2 sensors to the wSPO2 module can cause inaccurate SPO2 readings and damage the module. ToattachtheSPO2sensortothewSPO2module InserttheSPO2sensortotheDB9connectoronthewSPO2 module.Then,usingastandardscrewdriver,securelytighten bothscrews. SPO2 sensor Screws DB-9 connector wSPO2 module Charging Module Batteries Modulebatteriesarechargedinthemodulebatterycharger.Refertotheinstructionsprovided withthemodulebatterychargerforplacementanduseinformation. Replacing a Module Battery Eachwirelessmodulehasslotslocatedonbackofthedevicetohousethebattery.Module batteriesareinterchangeable,nonmagnetic,andcanbehandledintheMRmagnetroom.For operationalinformationaboutthewirelessmodules,seepage27. CAUTION To minimize the chance of image artifacts, never place module batteries in the MRI field of view. 120ImportantInformationExpressionMR200InstructionsforUse Toinstallamodulebattery Orientthebatteryasshownandthenslide thebatterybetweentheslotsonbackof themoduleuntilbothtabslatchinto place.Storethemodulesinthemodule holdersonthecart;see25fordetails. Slots Toremoveamodulebattery Usingthethumbandindexfingerofone hand,pressthetabsinwardandhold. Thenplacethethumborafingerofyour otherhandontherecessandpushthe batteryoutofthemodule. Recess Module Tabs Battery Tabs Battery Assigning the Network Channel of a Module NOTE The modules for your system may arrive pre-programmed to match the network setting of the cart. Inorderforamoduletocommunicatewith theMR200,thewirelessnetworksettingof eachmustbethesame. Thecurrentsettingofamoduleis indicatedbyitsilluminatednetworkicon. Foreaseofrecognition,eachnetworkicon hasauniqueletter(AE),shapeandcolor.
(ThesettingfortheMR200isdisplayedon theLCD;seepage216.) Button area Network icons Thewirelessnetworkchannelforthemoduleischangedbyusingthenetworkbuttonlocated underneaththelabelinthefrontupperleftcornerofthedevice;seetheillustrationbelow.(You willbeabletofeelaslightbumpwhenyoupassafingeroverthebuttonarea.) Thefollowingdirectionsforchangingthenetworkchannelapplytobothwirelessmodules, thoughtheprocessbelowdepictsonlythewECGmodule. ExpressionMR200InstructionsforUseImportantInformation121 Topressthenetworkbutton Placethemoduleonaflatsteadysurface(orholdthemoduleasshownin thefigure,right)andthenuseyourthumbtopressthenetworkbutton. Changing the Network Channel of a Module Beforestartingtheproceduretochangethenetworkchannelofthemodule,takenoteofthese conventionsthatareusedtoexplaintheprocess:
Intheprocedurebelow,thefollowingsymbolsareusedtoconveythestateofthenetwork icononawirelessmodule. Iconilluminated Iconblinking Intheprocedurebelow,thefollowingillustrationsareusedtoconveyactionsconcerning theuseofthenetworkbutton. Pressingthe button Releasingthe button Pressingandholding thebutton Repeating Tochangethenetworkchannelofawirelessmodule Step Action 1 Turnoffthemodulebyremovingthebattery;seepage121. 122ImportantInformationExpressionMR200InstructionsforUse Step Action 2 Insertabatteryintothemodule;seepage121. Thenetworkiconswillflashbrieflyandthenthecurrentnetwork iconwillilluminate(forexample,Cintheillustrationbelow). 3 Enterthenetworkchangemode:Afterthecurrentnetworkicon hasbeenilluminated(andwithin15secondsfrommodulepower up)pressandholdthenetworkbuttonuntilthecurrentnetwork iconbeginstorapidlyblinkthenreleasethebutton. NOTE If the network change sequence was not started within 15 seconds after the module has been turned on, network changes will not be allowed. In this case, you must cycle module power and restart the sequence. 4 Pressdownagainonthebuttonuntiltheiconstopsblinkingand thenreleasethebuttontochangethenetworksetting. Whenyoudothis,thenextnetworkiconinthesequencewillblink rapidly.(Inotherwords,ifthemodulewasoriginallyusingnetwork C,nowtheDiconwillbeblinking.)Repeatthissequenceof pressingdownandreleasingthebuttonuntiltheiconofthe networkyoupreferisrapidlyblinking.Ifyoupassthedesired network,simplycontinuepressingandreleasingthebuttonuntil thedesirednetworkisblinkingagain. ExpressionMR200InstructionsforUseImportantInformation123 Step Action 5 Whenyoureachthedesiredicon,pressandholdthebuttonfor approximately5secondstolockandsavethenewsetting. Theselectednetwork'siconwillturnoffwhilethebuttonis depressed.Thenitwillilluminate(notblink)whenthenewnetwork settingissaved.Onceilluminated,releasethebutton.Themodule willbeginusingtheselectednetworkchannel. NOTE Any part the network change sequence not completed will cause the module to revert to the network previously set 30 seconds after the network button was last released. Advanced User Options Expression Information Portal (Model IP5) ProvidingsystemcontroloutsidetheMRmagnetroom,the ExpressionInformationPortal(ModelIP5),hereafterreferred toastheIP5,isawirelessdevicethatalsofeaturesprinting capabilitiesandHL7dataoutputoptions. 124ImportantInformationExpressionMR200InstructionsforUse Additional Options Additionaloptions,suchasthoselistedbelow,maybesuggestedbyyourbiomedicaltechnician toincreaseuserease.TheMR200isconfiguredwithinput/outputportstopermittheconnection ofexternalequipment,including:
Facilityinformationsystems GatingsourceforMRIfunctions USBportforsoftwareinstallation Consultyourbiomedicaltechnicianortechnicalsupportwithspecificrequests. Caution CAUTIONS When adding equipment to an MR200 system (for example, an IP5), be aware that all devices should be at the same or a compatible software revision level. Contact technical support if you have questions or to upgrade software. Failure to observe this requirement could result in compatibility conflicts, communication problems, etc. The manufacturer is not responsible for any radio frequency interference caused by unauthorized modifications to the radios and/or antennas within this equipment. Such modification could inhibit proper MR200 system or device communications. Accessory List Accessoriesarelistedinthetablesbelowwithpartnumber(REF)information. CAUTION The MR200 has been validated with all of the accessories listed below. Only use these specified accessories as other types or brands may compromise the safety and accuracy of the MR200. CO2 LOFLO SAMPLE LINE, ADULT CANNULA, BOX 20 LOFLO SAMPLE LINE, PED. CANNULA, BOX 20 LOFLO SAMPLE LINE, NEO. CANNULA, BOX 20 LOFLO LINE, ADU DVD CANNULA,BOX 20 LOFLO LINE, PED DVD CANNULA, BOX 20 LOFLO LINE, ADU AIRWAY ADPT, BOX 20 REF 989803183241 989803183251 989803183261 989803183271 989803183281 989803183291 ExpressionMR200InstructionsforUseImportantInformation125 CO2 LOFLO SAMPLE LINE, ADULT CANNULA,BOX 100 LOFLO SAMPLE LINE, PED CANNULA, BOX 100 LOFLO SAMPLE LINE, NEO CANNULA, BOX 100 LOFLO LINE, ADU DVD CANNULA, BOX 100 LOFLO LINE, PED DVD CANNULA, BOX 100 LOFLO LINE ADU AIRWAY ADPT, BOX 100 ECG GEL, ECG/EEG, SKIN PREP, TUBE, 3-PACK CAB, 4 LD, MRI ECG CAB, 4 LD, NEO.MRI ECG CAB, 4 LD, CV MRI ECG ADVANCED APPS ECG CABLE ADVANCED FILTER ECG CABLE QUADTRODE MRI ECG PAD, 25/BOX ELCTRD, MRI ECG, QUTRD.CV, 25/BOX ELCTRD, MRI, NEO.QUDTRD, 25/BOX WIRELESS ECG PATIENT MODULE CAB, 4 LD, NEO.MRI ECG, IEC CAB, 4 LD, CV MRI ECG, IEC CAB, 4 LD, MRI ECG, IEC ADVANCED FILTER ECG, IEC ADVANCED APPS ECG CABLE, IEC Gating Cables CAB, DIGITAL GATING, GE, 3160 CAB, GATING, SIEMENS, 3160 CAB, GATING, PHILIPS ACH, 3160 CAB, DIG.GATING, HIT/TOSH, 3160 REF 989803185331 989803185341 989803185351 989803185361 989803185371 989803185381 REF 989803152291 989803152301 989803152331 989803152351 989803176381 989803170121 989803179031 989803179041 989803179051 989803183661 989803185441 989803185451 989803185461 989803185471 989803185481 REF 989803152821 989803152831 989803152841 989803152851 126ImportantInformationExpressionMR200InstructionsforUse Non-invasive Blood Pressure NIBP CUFF, SINGLE LUMEN, INFANT NIBP CUFF, SINGLE LUMEN, PEDIATRIC NIBP CUFF, SINGLE LUMEN, SMALL ADULT NIBP CUFF, SINGLE LUMEN, ADULT NIBP CUFF, SINGLE LUMEN, ADULT-L NIBP CUFF, SINGLE LUMEN, LRG ADULT NIBP CUFF, SINGLE LUMEN, LRG ADULT-L NIBP CUFF, SINGLE LUMEN, THIGH NIBP CUFF, SINGLE LUMEN, INFANT, DISP NIBP CUFF, SINGLE LUMEN, PEDIATRIC, DISP NIBP CUFF, SINGLE LUMEN,SMALL ADULT,DISP NIBP CUFF, SINGLE LUMEN, ADULT, DISP NIBP CUFF, SINGLE LUMEN, ADULT-L, DISP NIBP CUFF, SINGLE LUMEN, LRG ADULT, DISP NIBP CUFF, SINGLE LUMEN,LRG ADULT-L,DISP NIBP CUFF, SINGLE LUMEN, THIGH, DISP NIBP CUFF, SINGLE LUMEN, SAMPLE KIT,DISP NIBP CUFF, SINGLE LUMEN, NEO #1, DISP NIBP CUFF, SINGLE LUMEN, NEO #2, DISP NIBP CUFF, SINGLE LUMEN, NEO #3, DISP NIBP CUFF, SINGLE LUMEN, NEO #4, DISP NIBP CUFF, SINGLE LUMEN, INFANT #5, DISP ADULT PRESSURE INTERCONNECT HOSE NEONATAL PRESSURE INTERCONNECT HOSE Pneumatic Respiration PNEUMOGRAPH,CHEST,NM,3160 REF 989803182611 989803182621 989803182631 989803182641 989803182651 989803182661 989803182671 989803182681 989803182511 989803182521 989803182531 989803182541 989803182551 989803182561 989803182571 989803182581 989803182591 989803183171 989803183181 989803183191 989803183201 989803183211 989803183221 989803183231 REF 989803152791 ExpressionMR200InstructionsforUseImportantInformation127 Power EUROPEAN LINE CORD NORTH AMERICAN LINE CORD CORD, JUMPER, 25 FEET BRAZILIAN POWER CORD, 3 METER UK LINE CORD, 3 METER POWER CORD, AUS/NZL, 3 METER POWER CORD, S AFRICA, 3 METER POWER CORD, DANISH, 3 METER POWER CORD, ISRAELI, 3 METER POWER CORD, ARGENTINA, 3 METER POWER CORD, SWISS, 3 METER SPO2 QUICK CONNECT SPO2 PROBE, MRI QUICK CONNECT SPO2 CLIP, ADULT QUICK CONNECT SPO2 CLIP, PEDIATRIC QUICK CONNECT SPO2 GRIP, ADULT, 20/BOX QUICK CONNECT SPO2 GRIP, PED, 20/BOX QUICK CONNECT SPO2 GRIP, INFANT, 20/BOX QUICK CONNECT SPO2 GRIP, NEO, 20/BOX WIRELESS SPO2 PATIENT MODULE System ASSY, 3.7V BATTERY CHARGER, 3160 BATT.3.7V,WRLS.PAT.MDLE BATTERY, MRI, 14.8V, 5.08 AH, UL HANDLE HOOK, HOSE MANAGEMENT EXPRESSION INFORMATION PORTAL (IP5) REF 453564177501 989803168211 989803168221 989803173901 989803174171 989803181291 989803181321 989803181331 989803181341 989803181351 989803181361 REF 989803161991 989803166531 989803166541 989803166551 989803166561 989803166571 989803166581 989803183541 REF 989803152891 989803152881 989803169491 989803185121 865471 128ImportantInformationExpressionMR200InstructionsforUse Miscellaneous PAPER, THERMAL ARRAY, BLK, 50MM, OMNI QUICK REFERENCE GUIDE, MR200 MANUAL, SERVICE, MR200 MANUAL, OPERATORS, MR200, ENGLISH MANUAL, OPERATOR, MR200, DANISH MANUAL, OPERATOR, MR200, DUTCH MANUAL, OPERATOR, MR200, FINNISH MANUAL, OPERATOR, MR200, FRENCH MANUAL, OPERATOR, MR200, GERMAN MANUAL, OPERATOR, MR200, ITALIAN MANUAL, OPERATOR, MR200, NORWEGIAN MANUAL, OPERATOR, MR200, POLISH MANUAL, OPERATOR, MR200, PORTUGUESE MANUAL, OPERATOR, MR200, SPANISH MANUAL, OPERATOR, MR200, SWEDISH MANUAL, OPERATOR, MR200, TURKISH MANUAL, OPERATOR, MR200, JAPANESE MANUAL, OPERATOR, MR200, RUSSIAN MANUAL, OPERATOR, MR200, KOREAN MANUAL, OPERATOR, MR200, TRADITIONAL MANUAL, OPERATOR, MR200, INDONESIA REF MP05 453564357851 989803181911 989803184961 989803181971 989803181981 989803181991 989803182001 989803182011 989803182041 989803182051 989803182061 989803182071 989803182091 989803182101 989803182111 989803190941 989803190951 989803191221 989803191231 989803191351 ExpressionMR200InstructionsforUseImportantInformation129 130ImportantInformationExpressionMR200InstructionsforUse CHAPTER 2 System Overview FamiliarizeyourselfwiththeMR200anditscomponents.TheMR200combineswireless communications,radiofrequencyshieldinganddigitalsignalprocessingtechnologiestoprovide accurate,continuousandreliablepatientmonitoringperformanceinthedynamicmagnetic resonanceenvironment. ThemonitoringcapabilitiesoftheMR200canbeconfiguredtomeettheneedsofawide spectrumofpatientsfromneonatetoadult.Everyparametercanbeaccessedandadjustedfor theuniqueconditionofeachpatient.TheMR200accommodatesspecificmonitoringneeds, including:
Adult,pediatricandneonatalpatients Criticallyillpatients Patientundergoingsedation PatienttransportwithintheMRenvironment Interventionalprocedures Cardiacgating System Components AcompleteMR200systemconsistsofthefollowingcomponents:
Cart WirelessECGmodule WirelessSPO2module Modulebatterycharger OptionalIP5andprinter Batteriesandotheraccessoriesasneeded Use Model Asillustratedbelow,theMR200isintendedtobeusedtomonitorthevitalsignsofapatientinan MRmagnetroom.WhenpairedwiththeoptionalIP5,monitoringcapabilitycanbeextendedtoan MRcontrolroom,inductionroom,orrecoveryroomenvironmentandthegathereddatacanbe outputtoastripchartprinterorhospitalinformationsystem(HIS). ExpressionMR200InstructionsforUseSystemOverview21 MR200 MRI magnet room Modules to MR200
(wireless) Patient bed MR200 to IP5 (wireless) HIS system IP5 MRI control room Printer USB Ethernet Hospital network Acquisition and Control TheuseoftheMR200isrestrictedtoonepatientatatime.TheMR200displayspatient measurementsacquiredduringmonitoring.Controlsandsettingsforpatientmonitoringare providedlocallyatthedisplaypanelorremotely(forexample,intheMRIcontrolroom)when equippedwiththeIP5,whereconnectionsfortheprinterandthehospitalnetworkarealso available. Synchronization TheMR200willautomaticallyestablishcommunicationwiththewirelessmodulesandIP5(if equipped).However,duetotheusemodel,thedevicescanestablishcommunicationand synchronizepoweronsettingsdependinguponthestartupsequence:
IftheMR200bootsfirst,thenitssettingswillbereflectedattheIP5. IftheIP5bootsfirst,thenitssettingswillbereflectedattheMR200. IfusinganIP5,patientidentifiableinformation(name,IDnumber,etc.)willbeavailableafter synchronizationoccurs. 22SystemOverviewExpressionMR200InstructionsforUse WARNING The use model specifies one IP5 per MR200 system. If more than one IP5 is present on the MR200 system, there is an increased risk of units within the system not synchronizing and displaying incorrect or corrupted settings. CAUTION If the monitors settings are adjusted since they were last recalled or stored (manually, or via synchronization - if using an IP5 ), the current setup name (see page 2-14) will be appended with a plus symbol (+). The symbol will only be removed if the current settings are saved (see page 3-5) or if different settings are recalled (see page 3-4). Always confirm the proper settings for the MR200 and IP5 to ensure expected monitoring functionality. NOTE See DEFAULT SETUPS (on page 3-13) for information about power-on settings. Device Control Cart Menucommandsthatcontroltheparameterfunctionsforpatientmonitoringaresynchronized betweentheMR200andIP5.Commandsthatdonotdirectlycontrolthepatientparameters(for example,printerfunctions)willonlyaffectIP5.OthercontrolsettingsremainlocalizedtotheIP5 andarenotsynchronizedwiththeMR200,includingalarmsilenceandholdfunctionsandvolume settings(foracompletelisting,seetheIP5IFU). DesignedforuseintheMRmagnetroomandthroughouttheMRsuite,thecartisawheeled patientmonitorwithintegratedprocessing,power,displayandcontrolassemblies.Asillustrated below,thisselfcontainedmobilesystemalsoincludesstoragesolutionsforaccessories. ExpressionMR200InstructionsforUseSystemOverview23 Display and control assembly Patient connection panel Guide handles Wireless processing unit Battery compartments Speaker Storage basket Module holders Rear panel Wheel locks WARNING Never store ferrous items on the cart or in the storage basket. Failure to observe this warning may result in serious injury. CAUTION Do not place more than 4 pounds (1.8 kg) of combined weight in the storage basket, module holders and on the optional hose management handle hooks (not shown). Speaker Storage Basket Thespeakercommunicatesallaudiblesignals;seeSOUNDADJUSTonpage38fordetails. ThestoragebasketprovidesconvenientplacementforCO2cannulas,NiBPcuffs,SPO2 attachmentsandQuadtrodeelectrodes. 24SystemOverviewExpressionMR200InstructionsforUse Module Holders Themoduleholdersprovidesafestorageforthewirelessmodules. Placeawirelessmoduleinamoduleholdersothataconnected accessoryhangsdownwardthroughtheopening. Wireless Processing Unit Thewirelessprocessingunit(WPU)housesthecommunication,processingandpowersystems fortheMR200. Rear Panel Wheel Locks TherearpanelcontainstheACinlet,gatingconnectorandUSBport;seepage116fordetails. Locksareprovidedoneachwheeltopreventmovementofthecart.Duringusein theMRmagnetroom,stationthecartatasafemonitoringdistancethenpressdown oneachwheellocktoengageit.Whenthecartneedstobemoved,raiseeachwheel lockbeforeproceeding.(Seepage26forpositioningdetails.) WARNING Do not move the MR200 inside the 1,500 gauss field line of the MR magnet or within 1.5 m (4.9 feet), whichever is greater, as measured from the center line of the bore. Always secure the wheel locks when the MR200 is located in the MR magnet room. Failure to properly place the MR200 in the MR magnet room will result in monitoring system failure, and possible patient or user injury. Battery Compartments Thebatterycompartmentshousethecartbatteries;seepage117details. Guide Handles Theguidehandlesprovidethemeansforpositioningthecart. ExpressionMR200InstructionsforUseSystemOverview25 CAUTIONS Never apply excessive force, lean against, stack or drape objects over the guide handles;
instead, use specially designed hose management handle hooks; see page 1-28 for details. If the MR200 rolls to the face of the MR system due to magnetically induced pull force, Do not attempt to dislodge the MR200 by pulling from the display panel or guide handles;
instead, dislodge the MR200 by gently pulling from the lowest point of the base. This will prevent the base of the unit from experiencing higher MR pull forces in the vertical direction. Patient Connection Panel ThepatientconnectionpanelcontainsportsfortheNiBPandCO2attachments. NiBP port CO2 port NOTE Depending upon the equipped options, your MR200 may not have all indicated connections. Display and Control Assembly Thedisplayandcontrolassemblyhousesthedisplaypanelandspeaker,whichprovideuser informationandsystemcontrol;seepage210fordetails. CAUTION Never use the display and control assembly to position the cart; severe damage or failure can result. Only use the guide handles and, if necessary, the storage basket to position the cart. Positioning the MR200 Usetheguidehandlestomoveandpositionthecart.Alwayspositionthecartsothatyourview oftheLCDremainsunobstructedduringuse. TheMR200hasaninternalgausssensorwhich,incloseproximitytotheMRmagnet, automaticallyshutsdownNiBPandCO2monitoringfunctions.Toalertyoutomovethecartaway whenitistooclosetotheMRmagnet,theMR200willdisplaythefollowingwarningdialogbox message:
Movemonitorawayfrommagnet.NiBPandCO2(ifinstalled)havebeenshutdown. 26SystemOverviewExpressionMR200InstructionsforUse WhenpositioningtheMR200foruse,observethewarningandcautionsbelow. WARNING Do not move the MR200 inside the 1,500 gauss field line of the MR magnet or within 1.5 m (4.9 feet), whichever is greater, as measured from the center line of the bore. Always secure the wheel locks when the MR200 is located in the MR magnet room. Failure to properly place the MR200 in the MR magnet room will result in monitoring system failure, and possible patient or user injury. CAUTIONS If the MR200 rolls to the face of the MR system due to magnetically induced pull force, do not attempt to dislodge the MR200 by pulling from the display panel or guide handles;
instead, dislodge the MR200 by gently pulling from the lowest point of the base. This will prevent the base of the unit from experiencing higher MR pull forces in the vertical direction. Field strength variations may require you to move the MR200 away from the MR system if patient monitoring abnormalities or malfunctions are observed. Prior to clinical use, ensure that the allowable distance from the MR system is maintained for proper operation because variations in a particular MR magnet room (due to magnetic shielding techniques, manufacturer variability, future enhancements, etc.) can make it difficult to distinguish the 1,500 gauss level, as measured from the center line of the MR bore. The MR200s gauss sensor can be used to determine the correct position of the cart in the MR magnet room. Wireless Modules ThewirelessmodulesarebatteryoperatedandcommunicatewiththeMR200througha bidirectional2.4GHzdigitalmodulationlink,whichisautomaticallyestablishedapproximately30 secondsafterpowerisappliedtothemodule.Thewirelessmodulesoperateatupto30feet(9.1 m)fromtheMR200intheMRIroomorinthesameshieldedroom. WARNING The system use model specifies one wECG module and one wSPO2 module per MR200 system network. If more than one type of each module is communicating on the same network, then waveform and measurement corruption will occur. ExpressionMR200InstructionsforUseSystemOverview27 wECG Module ThewirelessECGmodule(wECG)transmitsmeasuredECG signalsthroughawirelesslinktotheMR200.Themodule alsoreceivesinformationtoperformcommandedtasks(for example,leadconfigurationandfiltermodechanges).Two ECGchannelscanbedisplayedandareavailablefor interfacingwiththeMRsystemcardiacgatinginput. wSPO2 Module ThewirelessSPO2module(wSPO2)transmitsmeasured bloodoxygensaturation,plethysmography,peripheralpulse data(SPO2)andpneumaticrespirationvaluesthrougha wirelesslinktotheMR200.Theprocessedinformationcan bedisplayedandoutputforinterfacingtotheMRsystem pulseperipheralandrespirationgatinginput. Module Status Indicator wECG module Status indicator wSPO2 module Status indicator Eachmodulehasastatusindicator,atwocolorLED,thatdenotesthefollowingconditions. Indicator State Not applicable Flashing Solid Flashing Solid Color None Green Green Red Red Module Status Power No battery is installed or the charge is insufficient to power the module. Battery power good Battery power good Low battery condition Low battery condition Communications Not applicable Not communicating Good communication Not communicating Good communication NOTE For battery details, see page 1-20; and, for communications details, see page 1-21. 28SystemOverviewExpressionMR200InstructionsforUse System Power-Up and Communications Verification WARNING Always perform operational verification prior to use and during monitoring by ensuring proper communications between the MR200, the wireless modules and the IP5 (if equipped). Failure to ensure proper communications can result in the loss of patient monitoring and the loss of data transfer in networked systems equipped with an IP5. If a device fails to function properly, remove it from use and contact technical support. TheMR200reachesanoperationalstatewithin60secondspowerupandattainsfull measurementaccuracyafter2minutes. ToapplypowertotheMR200andverifysystemcommunications Step 1 2 3 4 5 6 7 8 Action Ensurethatabatteryisinstalledineachwirelessmodule(seepage 120). WiththecartbatteriesinstalledandwiththeMR200connectedto ACpower(seepage118),pressthepowerswitch.
(Optional)ifequipped,turnontheIP5. Ensurethatthenetworksettingofeachmodule(seepage121) matchesthenetworksettingoftheMR200(seeonpage216). EnsurethatthenetworksettingoftheIP5(ifturnedoninstep3, above)matchesthenetworksettingoftheMR200. EnsuregoodcommunicationbetweeneachmoduleandtheMR200 bycheckingthemodulesstatusiconontheLCD(seeonpage2 16).
(Optional)ifequippedwithanIP5,proceedaccordingtotheprinter option:
Ifequippedwithaprinter,ensuregoodcommunication betweentheMR200andtheIP5bycheckingtheprinting statusiconontheLCD(seepage216). Ifnotequippedwithaprinter,checkthedisplaypanelofthe IP5forhostconnectiontotheMR200. Ensureproperoperationofeachpatientparameterandalarms. Refertoappropriatechaptersinthismanual. CAUTION If power to wireless device with established communications is lost or removed, its network connection will be dropped. ExpressionMR200InstructionsforUseSystemOverview29 System Parameters TheMR200simultaneouslyprocessesanddisplaysmultipleparameters,waveforms,numeric valuesandalarms.Allpatientinformationisprovidedonthedisplaypanel.Afullyequipped MR200includesmonitoringforthefollowingparameters:
Electrocardiogram(ECG),dualchannel Heartrate Bloodoxygensaturation/pulseoximetry(SPO2) Noninvasivebloodpressure(NiBP) EndtidalandinspiredCO2(CO2) Respiration(CO2orbellows) NOTE Depending upon the equipped options, your MR200 may not have all indicated parameters. Display Panel Thedisplaypanel,whichincludestheLCD,keypadandcontrolknob,formstheuserinterfaceof theMR200. LCD Keypad Control knob Power switch Status indicator 210SystemOverviewExpressionMR200InstructionsforUse Power Switch Keypad Poweriscontrolledbythepowerswitch
:
PressthepowerswitchtoturnontheMR200. PressandholdthepowerswitchforapproximatelytwosecondstoturnofftheMR200. Thekeypadhaseightkeysforquickaccesstofrequentlyusedfunctions. Key Function Controls the alarm sound; see page 9-7 for details. Silence Suspend NiBP Patient Trends Print Setup Main Enters suspend mode; see page 2-19 for details. Begins a new NiBP measurement if no reading is in progress, or ends a current measurement; see chapter 4. Selects the type of patient to be monitored; see page 3-10 for details. Accesses the HISTORY menu when in normal mode (see page 2-18) and an individual graphic trend when a vital sign box is highlighted (see chapter 10). Initiates a 30 second print when using an equipped IP5. Accesses the SETUP menu; see page 3-2 for details. Closes any menu and returns to the normal operating mode (see page 2-18) ExpressionMR200InstructionsforUseSystemOverview211 Control Knob Status Indicator Thecontrolknoballowsyoutonavigateandselectoptions,itemsandsettingsinthemenu system:
Rotatingthecontrolknobclockwisemovesthecursordownandrotatingtheknob counterclockwisemovesthecursorup. Inthenormalmode,rotatetheknobtohighlightdifferentvitalsignboxesandpressthe knobtoopentheassociatedmenu. Whenamenuisdisplayed,rotatetheknobtohighlightoptionsanditemsandpressthe knobtoselectthatoptionoritem. Whenaoptionisdisplayed,rotatetheknobtohighlightsettingsanditems,andpressthe knobtoselectthatsettingoritem. NOTE In the menu system, grayed out panes, options labelled UNUSED or THIS ITEM IS LOCKED when selected, reflect features or options that are inaccessible, not configured, or not installed. ThestatusindicatorisamulticolorLEDthatdenotesthepowerconditionofthecart,asdetailed inthetablebelow. Indicator State Not applicable Flashing Color None Green Green Solid Yellow Red Solid Solid Power Status Definition Not on external power (batteries may be installed) AC power connected (batteries may be installed) On AC power (batteries, if installed, are charging) On battery power On battery power with a low battery condition WARNING A solid red light indicates battery power has fallen below the required limit and system shutdown with loss of monitoring will occur. Immediately locate an AC outlet and connect the MR200. Power Switch Off Off On On On 212SystemOverviewExpressionMR200InstructionsforUse LCD Thedisplaypanelfeaturesacolorliquidcrystaldisplay(LCD).Alwaysadjustthecartsothatyour viewoftheLCDcomplementsyourlineofsight. CAUTION Never apply unnecessary force to the LCD as it can result in screen damage or failure. NOTE To change the language displayed by the MR200, see page 11-16. Display Areas Fourdataareasaredisplayedinthenormaloperatingmode(seepage218fordetails):
Informationalarea(1,below) Vitalsignboxesarea(2,below) Communicationandpowerstatusdisplayarea(3,below) Vitalsigntracesarea(4,below) 4 1 2 3 NOTE If a parameter (or an ECG trace) has been turned off, its portion of the LCD will be blank. To turn a parameter on or off, use the PARAMETER SELECTION menu; see page 3- 7 for details. ExpressionMR200InstructionsforUseSystemOverview213 Informational Area Theinformationalarea,alongthetopofthescreen,providesuserandpatientinformation:
Time Symbol area Patient Current setup name Notification area Timeprovidescurrenttime,givenina12or24hourformat(hh:mm:ss);seeSetTimeon page312fordetails. Symbolareaprovidesindicationsofthealarmsoundsetting,configurationstatus,and heartbeatandrespirationdetection. The indicatesanactivealarmsoundsetting,displayedatalltimes(unless temporarilyobscuredbyamenuordialogbox);seechapter9. Whenenabled,the indicatesheartbeatdetection,flashingforeachdetected pulse;seeHRTONESOURCEonpage39. WhenCO2isonandwithinspecifiedlimits,the indicatesrespirationdetection, flashingatafrequencythatmatchesthecurrentbreathrate;seechapter7. Patientdisplaystheselectedpatienttype;seepage310. Currentsetupnamedisplaysthepowerondefault(seepage313)orthememoryblock thatwasused(seepage34)forthecurrentsetupofthemonitor,wheretheplussymbol
(+)indicatesasettingchangehastakenplace;seeSynchronizationonpage22. Notificationareadisplaysuptotwoinformational,statusand/ortechnicalmessagesata time;and,ifthreeormoreexist,themessageswillcycle.
(Twomessagesareshownintheexampleabove;seeListingofAlarmsonpage916 formessagesanddetails.) Vital Sign Boxes Area Thevitalsign(VS)boxesarea,alongtherightsideandthelowerportionofthescreen,contains individualpanesthatprovidevitalsignnumericdata,alarmlimitsettingsandviolationindictions, trendarrowindications,andmenuaccessforeachoftheparameters. 214SystemOverviewExpressionMR200InstructionsforUse ECG VS box (see page 4-16) SPO2 VS box (see page 5-7) CO2 VS box (see page 7-6) NiBP VS box (see page 6-7) RESP VS box (see page 8-3) No Data Available Indication UndercertainconditionsoneormoreofthenumericsintheVSboxesmaydisplaythreedashes
()toindicatethatnodataisavailable. ExpressionMR200InstructionsforUseSystemOverview215 Dependinguponthenatureofthisindication,analarmmaybegeneratedifnoparameterdatais available.Inthiscase,thedasheswillbedisplayedinredandanalarmwillsound. Analarmisgeneratedwhen:
Parameterdatawaspresentbutisnolongeravailable(forexample,asensorthatwas appliedmaynolongerbeconnectedtothepatient). Thehardwareassociatedwithaparameterhasexperiencedaproblemorfailurethat preventsproperoperation. Noalarmisgeneratedwhen:
Amoduleoranothermeasurementdevicewasjustturnedonorappliedtothepatient
(allowafewsecondsforcommunicationtobeestablished). Thefirstreadinghasnotyetbeentakenortheparameterisinastartupcondition. Themeasurementvaluesaredistortedorthesignalisinadequate. Suspendmodewasjustexited. Communication and Power Status Display Area Thecommunicationandpowerstatusdisplayarea,alongthebottomofthescreen,provides indicationsofthesystemnetworksetting,printingstatus,andthecommunicationandpower statusofthecartandthewirelessmodules:
Printing status icon wSPO2 module status icon Network icon Cart status icon wECG module status icon PrintingstatusicondisplaysthestatusoftheIP5printer,whenequipped:
Whenreadytoprint, isdisplayed. Whenprinting, untilcompletion. isdisplayed,indicatingthetimeremaining(inseconds) Whennotinstalledorifacommunicationproblemexists, isdisplayed. Whenavailablebutunabletoprint, isdisplayed. Cartstatusiconindicatesthepowerstatusofthecart:
Where power. Where power. indicatesthecarthasbatteriesinstalledandisoperatingonAC indicatesthecarthasnobatteriesinstalledandisoperatingonAC 216SystemOverviewExpressionMR200InstructionsforUse Whenonbatterypower,thebatterylevelwithatimeremainingcounterisdisplayed;
and,iflessthan45minutesofoperatingtimeremain,then analarmissounded. isdisplayedand NOTE After the start of battery power mode, the time remaining counter may take several minutes to stabilize. wSPO2modulestatusiconindicatesthecommunicationandbatterystatusofthewSPO2 module:
Where indicatesthebatterylevel(withatimeremainingcounter,formatted inhours:minutes).Iflessthan45minutesofoperatingtimeremain,thentheicon turnsred,flashes,andanalarmissounded. Where indicatesthereisnocommunicationbetweenthecartandmodule. wECGmodulestatusiconindicatesthecommunicationandbatterystatusofthewECG module:
Where indicatesthebatterylevel(withatimeremainingcounter,formatted inhours:minutes).Iflessthan45minutesofoperatingtimeremain,thentheicon turnsred,flashes,andanalarmissounded. Where indicatesthereisnocommunicationbetweenthecartandmodule. NetworkiconindicatesthecurrentwirelessnetworkchanneloftheMR200.Fivenetwork channelsareavailable(AE),asshownbelow.Thischannelsettingcanbechangedtomeet theneedsofyourfacilityandoperatingenvironment,butyoumustalsochangethesetting ofthewirelessmodules(andIP5,ifequipped)tomatchthenewMR200channelforproper systemcommunications;seepage315. Network channel A Network channel B Network channel C Network channel D Network channel E WARNINGS Care should be taken to guard against inadvertent changes to the network setting. Before use, always ensure that all devices are communicating properly. Failure to do so may cause a lapse in patient monitoring. In environments where multiple MR200s are being used, you must be aware of each systems network setting. Operating multiple MR200s on the same network or with a wrong network setting will interfere with communications, and incorrect or corrupted patient vital signs information will be displayed as a result. ExpressionMR200InstructionsforUseSystemOverview217 Vital Sign Traces Area Thevitalsigntracesarea,inthemiddleofthescreen,providesvitalsign(VS)waveformsand systemstatusmessages.Tracewaveforms(AD)areuniquelycoloredtomatchtheir correspondingVSbox,andarefixedacrosstheLCDandupdatedwithanerasebar:
Trace A Trace B Trace C Trace D TraceAisassignedanddisplayeddependingupontheECGmenuoptions;seepage416. System message area TraceBdisplaysECG2whentwoECGsourcesareon. TraceCdisplaystheSPO2waveform;seepage57. TraceDdisplaystheCO2waveform;seepage76. Systemmessageareaprovidessystemmessages,asdetailedthroughoutthismanualand inListingofAlarmsonpage916. Modes of Operation TheMR200hasthreedifferentoperatingmodes. Normal Mode Normalmodeisthestandardoperatingmode.Innormalmodetherearenoopenmenusor highlightedvitalsignboxes;thesystemisreadyformonitoring. Toenternormalmode PresstheMainkey
. AnyopenmenuwillcloseandanyhighlightedVSboxwillbedeselected(thenormalscreenwillbe displayed;seepage213). 218SystemOverviewExpressionMR200InstructionsforUse Suspend Mode Suspendmodesupportspatientclinicianinteractionwithoutnuisancealarms,whichisuseful whereminimaluserinteractionisrequired(forexample,whileapatientisnotbeingmonitored, duringtransitionswhenremovingthemonitorfromonepatientandconnectingitonanother,or ifcertainadjustmentsarebeingmadetothedeviceorotherequipment).Insuspendmode, currentpatientinformationisprovided,butwiththefollowingoperationalexceptions:
Audiblealarmsaredisabled;
ActiveautomaticNiBPmeasurementsaresuspended;
DefaultinflationpressuresareusedforallmanualNiBPreadings;and, Automaticprintoutswillnotbegenerated. Toentersuspendmode PresstheSuspendkey
. SUSPENDEDwillbedisplayed(inred,nearthecenterofthescreen). Toexitsuspendmode PresstheSuspendkey. Simulation Mode Simulationmodesupportstrainingandtestingfunctionsbydisplayinginternallygenerateddata forvitalsignwaveforms,numericsandstatuses.Insimulationmode,allpatientmonitoringis discontinued.Forsimulationmodedetails,seepage1114. ExpressionMR200InstructionsforUseSystemOverview219 220SystemOverviewExpressionMR200InstructionsforUse CHAPTER 3 Getting Started Initialsetupisimportanttoachieveexpectedresultsandseamlessoperation.Setupmenus providetheabilitytoselectmonitoringoptions,controlfunctions,storeandrecalloperating configurationsandaccesstestroutines. CAUTIONS A minor but noticeable degradation in wireless module communications may occur in the presence of high-powered radios. Prior to clinical use, the user must be aware of the minimum distance from the MR magnet that must be maintained for proper operation; see Positioning the MR200 on page 2-6 for details. Monitor Initialization Afterpowerup,theMR200typicallytakesafewsecondstoinitialize.Duringthisperiod,theLCD mayremainblankuntiltheprocesscompletes.TheMR200canbeginmonitoringfunctionsfrom aninitialfactorydefaultstateorfromapreconfiguredstate,dependinguponthewaythestored configurationsandpatientdataareprogrammedforstartup. Visuallycheckingthepatientandconfirmingchangingmeasurementsagainstothervitalsigns shouldbestandardroutinesduringuse. Warning WARNING When using an IP5, make sure that the content of the RECALL SETUPS option matches that of the MR200 option, and that the same option is selected as the default setup on both systems (see page 3-4). This is important because the device first booted will determine the power-on settings of the system (that is, the MR200 and IP5). Initial Alarm Setting Indication Afterpowerupandimmediatelyfollowingtherecallofastoredsetup,theMR200providesan initialindicationofthealarmvolumebysoundingthetoneatitscurrentsettingfor5seconds. Duringthisinterval,CHECKALARMVOLwillbedisplayed. AlarmHoldistheinitialstateofthealarmfunctionsfollowingpowerup,andthenafterthewait period(120seconds)Armedbecomesthenormalstate.IntheArmedstate,thealarmfunctions ExpressionMR200InstructionsforUseGettingStarted31 operateasfollows:
Thealarmtonewillsoundwhileanalarmconditionexists,providedthatanyprealarm sounddelayhasexpiredandthe symbolisdisplayed. Messagesrelatedtootheralarmsoundstateswillberemovedfromthedisplay. Analarmconditionnotpreviouslyplacedinasilencedstatewillcausethealarmtosound
(providedthatanyprealarmsounddelayhasexpired). SETUP Menu FromtheSETUPmenu,youcanconfiguretheMR200tomeetyourpatientmonitoringneeds:
Individualsetupconfigurationscanbesavedandrecalled. Availableparameterscanbeturnedonandoff. Patienttypecanbeselected. Soundscanbeadjusted. Dateandtimecanbeset. Networkdesignationcanbeset. Sweepandrespirationspeedscanbeselected. Defaultconfigurationforstartupcanbeselected. Alarmlimitscanbeset. Remoteprinterfunctionscanbeselected. Warning WARNING When using an IP5, wait at least 4 seconds if performing a recall or setting a parameter value, as these require a few seconds to propagate through the system. Performing another recall within 4 seconds of a previous recall or after a value change, may result in improperly recalled data. TheSETUPmenuaccessesmenusforsetupandcontroloftheMR200. ToentertheSETUPmenu PresstheSetupkey
. ThefollowingoptionsareavailableintheSETUPmenu:
ALARMSETUP(seechapter9fordetails) 32 GettingStartedExpressionMR200InstructionsforUse MONITORSETUP(seebelow) PRINTERSETUP(seechapter10fordetails) MONITOR Menu TheMONITORSETUPoption(intheSETUPmenu)openstheMONITORmenu,whichcontains optionsforsetupandcontrolofpatientmonitoring. MONITOR menu Setup key Control knob TochangesettingsintheMONITORmenu Step Action 1 2 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. ExpressionMR200InstructionsforUseGettingStarted33 Step 3 Action Turnthecontrolknobtoselectanyofthefollowingsystemwide optionsandthenpresstheknob:
RECALLSETUPS STORESETUPS PARAMETERSELECTION SOUNDADJUST PATIENT PEDIATRICECG SETTIME DEFAULTSETUPS SWEEPSPEED RESPSPEED NETWORK SERVICE(BIOMED) Foroptionsinformation,seetheappropriatesectionsbelow. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeothersettings,repeatsteps3and4. PresstheMainkey toclosethemenu. 4 5 6 Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. RECALL SETUPS Restoresthemonitortoaparticularsetupthatwaspreviouslysaved(seeSTORESETUPSonpage 35forconfigurationdetails,andseeDEFAULTSETUPSonpage313forthepoweronsetting.) NOTE The name of the current setup is displayed in the top left corner of the screen (see page 2-14). If a setup was changed, a plus symbol (+) will appear next to the setup name ( AF, User or Factory). Thefollowingmemoryblockchoicesareavailable:
A B C D 34 GettingStartedExpressionMR200InstructionsforUse E F USER(Factoryprogrammingwillberecalledifthisoptionisselectedbutwasnotpreviously stored;seepage35.) Torecallasetupfrommemory Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoRECALLSETUPSandthenpresstheknob:
TheRECALLSETUPSmenuappears. Turnthecontrolknobtoselectoneofthefollowingmemoryblocks andthenpresstheknob:
A B C D E F USER Theselectedmemoryblockisrecalledforthesettingsofthe MR200.(Ifdisplayed,the+symbolisremoved.) STORE SETUPS Storesuptosevensetupsfordifferentprocedures,patienttypesorusers,whichcanthenbe recalledwithouttheneedofextrasetup.Thesememoryblocksaremaintainedbyalonglife batteryorstaticRAM,savingthedata,evenwhenpoweredoff.Storablesettingsinclude:
Systemsetups Patienttype,alarmssettings,autosetcalculationpercentage,latchedorunlatchedand soundlevel ECGselectedlead,scale,tracespeed,filtermode,magnetcontrol,QRStonecontroland heartratesource SPO2size,averagingtimeandHRtonesource CO2size,grids,unitsandrespirationspeed ExpressionMR200InstructionsforUseGettingStarted35 NiBPmanualorautosettingandautomatictimeinterval Trendgraphtimebaseandscale Printcontrol,tracedelay,speedandselectedtraces Thefollowingmemoryblockchoicesareavailable:
A B C D E F USER Tostoreasetupinmemory Step 1 Action ConfigurethesettingsandoptionsoftheMR200asdesired. 2 3 4 5 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSTORESETUPSandthenpresstheknob:
TheSTORESETUPSmenuappears. Turnthecontrolknobtoselectoneofthefollowingmemoryblocks andthenpresstheknob:
A B C D E F USER Theconfigurationisstoredintheselectedmemoryblock.(If displayed,the+symbolisremoved.) 36 GettingStartedExpressionMR200InstructionsforUse PARAMETER SELECTION Controlsmonitoringfunctions,asindicatedbytheabsenceorpresenceoftheVSboxforthe parameter,exceptECG(seebelow). Thefollowingchoicesareavailable:
ECGallowselectrocardiogrammonitoring:
ONturnsontheECGparameter.(Default) OFFturnsofftheECGparameter.HeartratewillremainintheVSboxallowingitto bedisplayedfromanotherselectedsourceorifHRSOURCEissettoAUTOandECGis inaLEADFAILcondition. NiBPallowsnoninvasivebloodpressuremonitoring:
ONturnsontheNiBPparameter.(Default) OFFturnsofftheNiBPparameter. SPO2allowsoxygensaturationofarterialbloodmonitoring:
ONturnsontheSPO2parameter.(Default) OFFturnsofftheSPO2parameter. CO2allowsCO2andrespirationmonitoring(ifinstalled):
ONturnsontheCO2andtheCO2derivedrespirationparameter. OFFturnsofftheCO2parameter.(Default) RESPallowsbellowsrespirationmonitoring:
ONturnsonthebellowsderivedrespirationparameter. OFFturnsofftherespirationparameter.(Default) Tocontrolaparameter Step Action 1 2 3 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoPARAMETERandpresstheknob. ThePARAMETERmenuappears. ExpressionMR200InstructionsforUseGettingStarted37 Step 4 Action Turnthecontrolknobtoselectoneofthefollowingparametersand thenpresstheknob:
ECG NiBP SPO2 CO2(ifinstalled) RESP Theparametersactivationmenuappears. 5 Turntheknobtothedesiredsettingandthenpresstheknob. SOUND ADJUST Warning WARNING The alarm sound can be turned off, as indicated by the symbol. Always ensure that the alarm sound setting is appropriate for the monitoring environment and for each patient. The alarm sound volume is adjustable for suitability to various clinical environments. When you use the MR200, always ensure that the alarm sound can be heard above the ambient noise level; otherwise, treatment of the patient could be delayed. Controlsalarm,heartrateandkeypadtones,andthevolumesettingsforeach. NOTE While in this menu, tones generated during patient monitoring are disabled and REAL TONES DISABLED will be displayed. Thefollowingchoicesareavailable:
ALARMScontrolsthealarmsound(identicaltoand interactivewithALARMSOUND;seepage912):
ONturnsonthealarmsound,where indicates thatthesoundhasbeenenabled.(Default) OFFturnsoffthealarmsound,where indicates thatthesoundhasbeendisabled.(Onlythealarm soundwillbedisabled;thevisualalertfromthesource oftheviolationstillflashesinred.) 38 GettingStartedExpressionMR200InstructionsforUse HRTONESOURCEsetsthesourceusedfortheheartratetone(identicaltoandinteractive withthesameoptionintheECGandSPO2menus):
OFFremovestheheartsymbolfromthedisplayandproducesnotone.(Default) QRSprovidesatonemodulatedbytheQRSdetectionfromtheECGvitalsign. SPO2providesatonemodulatedbytheSPO2vitalsign,wherealowervalue producesalowerpitch. ALARMVOLUMEsetsthealarmsoundlevelfrom110.(Default=4) PULSEVOLUMEsetsthepulsetonevolumefrom110.(Default=4) CLICKTONEcontrolsthekeypadtonegeneration.(Default=On) CLICKVOLUMEsetstheclicktonevolumefrom110.(Default=4) Toadjustthesounds Step Action 1 2 3 4 5 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSOUNDADJUSTandpresstheknob. TheSOUNDADJUSTmenuappears. Turnthecontrolknobtoselectoneofthefollowingmenusand thenpresstheknob:
ALARMS HRTONESOURCE ALARMVOLUME PULSEVOLUME CLICKTONE CLICKVOLUME Theselectedmenuappears. Turntheknobtothedesiredsettingandthenpresstheknob. Thesettingisenteredandabriefsoundatthecorrespondinglevel isproduced. ExpressionMR200InstructionsforUseGettingStarted39 PATIENT Selectsthetypeofpatienttobemonitored. DeterminingthePatientType IEC80601230Edition1.0,theinternationalstandardregardingparticularrequirementsfor safety,includingessentialperformanceofautomaticcyclingnoninvasivebloodpressure monitoringequipment,definespatienttypesintwocategories:neonatalandadult.Neonatal patientsaredefinedbytheapproximateagerangeofbirthtoafewweeks.Allotherpatientsare identifiedasadults. ANSI/AAMISP10:2008,theAmericanNationalStandardformanual,electronic,orautomated sphygmomanometers,definespatienttypesaccordingtoagelimitations,asindicatedinthetable below. Patient Type Neonatal Pediatric Adult Age Birth to 28 days 29 days to 12 years Greater than 12 years Similarly,theFood&DrugAdministrationdefinespatientswithintwocategories:pediatricsand adults.Eachcategoryisfurtherdefinedintosubgroupsaccordingtoapproximateage. Patient Type Pediatric Pediatric Pediatric Pediatric Adult Subgroup Newborn (neonate) Infant Child Adolescent
---
Approximate Age Range Birth to 1 month Greater than 1 month to 2 years Greater than 2 to 12 years Greater than 12 to 21 years Greater than 21 years CAUTION There may be occasions when a particular mode is not suitable for its apparent category of patients based on age alone. In these cases, a clinical decision shall be made to use another patient type or measurement technique. The clinical decision shall be based on all of the factors listed in Determining Patient Type (above) to ensure the best possible and most timely measurement acquisitions. Regardlessofthedefinition,eachagencyrecognizesthatthepatienttypedescriptionscanbe arbitraryandthatthefollowingpatientfactorsaremoreaccurateindeterminingtheappropriate methodofpatientmonitoringandtreatment:
Weight Bodysize 310 GettingStartedExpressionMR200InstructionsforUse Limbcircumference Physiologicaldevelopment Neurologicaldevelopment Neuromuscularcoordination Accordingly,theMR200usesseveraloperationalparameters,includingcuffinflationpressure andpulsesensitivity,thatvarydependingontheselectedpatienttype.(Alwaysreferto informationaboutthecorrespondingparameterforotherpossibleconsiderationswhen determiningthepatienttype.) Thefollowingpatienttypesareavailable:
ADULT(Default) PEDIATRIC NEO(whenselected,PEDIATRICECGisalwayson.) NOTE Changing the PATIENT type causes the alarm to sound, the PATIENT indication to be revised, CHANGE NiBP CUFF to be displayed for 30 seconds, and the alarm limit settings to revert to the default values (see the table on page 9-15 for details). Toselectthepatienttype PressthePatientkey
.Turnthecontrolknobtothedesiredtypeandthenpresstheknob. PEDIATRIC ECG ProvidesadditionalECGfilteringwhenpatients,particularlypediatrics,presentwithnarrowQRS complexesand/orhigh(120BPM)heartrates. Thefollowingchoicesareavailable:
OFFturnsthepediatricECGfilteroff.(Default) ONprocessesECGdatausingapediatricalgorithm,inadditiontothegradientfilter setting,andoperatesunderthefollowingconditions:
WhenanECGtraceisprinted,PEDECG=ONorPEDECG=OFFwillappearonthestrip. ThesettingwillbesavedduringSTORESETUPSandrecalledduringRECALLSETUPS. ExpressionMR200InstructionsforUseGettingStarted311 NOTE When PATIENT is set to NEO, PEDIATRIC ECG is set to ON and locked. When the PATIENT type is changed to ADULT, PEDIATRIC ECG will be set to OFF and unlocked. Pediatric ECG Patient Type Off On On Adult Pediatric Neonatal Condition Unlocked Unlocked Locked TocontrolthepediatricECGfilter Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoPEDIATRICECGandpresstheknob. ThePEDIATRICECGmenuappears. Turnthecontrolknobtothedesiredsettingandthenpressthe knob. SET TIME Setsthetimeanddate.Thetime,continuouslyoperating,isdisplayedonLCDandthedate formatisMMMDD,YYYY(forexample,JAN01,2013). Thefollowingchoicesareavailable:
FORMATchangestheformatofthedisplayedtime 12hour 24hour(Default) SECONDsetsthesecond. MINUTEsetstheminute. HOURsetsthehour. DAYsetstheday. 312 GettingStartedExpressionMR200InstructionsforUse MONTHsetsthemonth. YEARsetstheyear. ENTERsavesanychanges. Tosetthetimeanddate Step Action 1 2 3 4 5 6 7 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSETTIMEandpresstheknob. TheSETTIMEmenuappears. Turnthecontrolknobtoselectanyofthefollowingtimeoptions andthenpresstheknob:
FORMAT SECOND MINUTE HOUR DAY YEAR Theselectedoptionappears. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeothersettings,repeatsteps4and5. TurnthecontrolknobtoENTERandthenpresstheknob. Thechangesaresaved. DEFAULT SETUPS SelectstheinitialsettingsusedwhenpowerisappliedtotheMR200. Thefollowingchoicesareavailable:
FACTORYusesthefactoryprogrammedsettings.(Default) USERusessettingsfromtheUSERmemoryblock;seeRECALLSETUPSonpage34. ExpressionMR200InstructionsforUseGettingStarted313 Tosetthedefaultsetups Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoDEFAULTSETUPSandpresstheknob. TheDEFAULTSETUPSmenuappears. Turnthecontrolknobtoselectoneofthefollowingoptionsand thenpresstheknob:
FACTORY USER Thepowerondefaultisset. SWEEP SPEED ChangesthetracespeedofallwaveformsexceptCO2. Thefollowingsweepspeedchoices(inmillimeterspersecond)areavailable:
50mm/s 25mm/s(Default) Toadjustthesweeprate SeeChangingtheWaveformSpeedonpage417. RESP SPEED SetsthetracespeedoftheCO2waveform. Thefollowingsweepspeedchoices(inmillimeterspersecond)areavailable:
25mm/s 12.5mm/s(Default) 6.25mm/s 3.125mm/s 1.5625mm/s 314 GettingStartedExpressionMR200InstructionsforUse 0.33333mm/s ToadjustthesweeprateforCO2respiration SeeChangingtheWaveformSpeedonpage76. NETWORK Setsthewirelesscommunicationschannelforthecart.Thenetworkusedbythecartandthe wirelessmodulesmustbethesame. Thefollowingnetworkchoicesareavailable:
A(Default) B C D E Tosetthenetwork Step Action 1 2 3 4 5 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoNETWORKandpresstheknob. TheNETWORKmenuappears. Turnthecontrolknobtoselectoneofthefollowingoptionsand thenpresstheknob:
A B C D E TheMR200networkchannelisset. IfequippedwithanIP5,ensurethatthenetworkusedbythe wirelessmodules(seepage121)andtheIP5areidenticaltothe selectionmadeinstep4. ExpressionMR200InstructionsforUseGettingStarted315 SERVICE(BIO-MED) Allowsaccesstopressureandmiscellaneousconfigurationsettings,diagnosticroutinesand firmwareinformation;seepage1112fordetails. 316 GettingStartedExpressionMR200InstructionsforUse CHAPTER 4 Monitoring ECG Electrocardiogram(ECG)monitoringinsidetheMRIenvironmentisuniqueandrequires additionalprecautionstopermitsafepatientprocedures.Itisalwaysimportanttoremember thattheriskofradiofrequency(RF)heatingiseverpresentwhenanyelectricalconductors(for example,ECGleadcables)areplacedintheMRsystembore.Byfollowingtheoperating precautions,warningsandtheguidelinesbelow,theseriskscanbeminimized.TheECG parameterisintendedforECGmonitoringmodeandnotdiagnosticECGmonitoring. WARNINGS The MR200 is not intended for use with patients using pacemakers or electrical stimulators. Arrhythmias, erratic heartbeats, operation of electrical stimulators, pacemakers and patient motion can result in inaccurate readings. Rate meters may continue to count pacemaker rates during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. If questionable readings are obtained, check the patient's vital signs by alternate means before administering medication. CAUTION Pacer pulses are not specifically rejected by the MR200 and may be treated as part of MRI gradient noise. Gradient filtering attempts to remove high frequency pulse shaped waveforms from the ECG signal which may resemble pacer waveforms, and it is possible that the pacer waveform may be removed with the gradient noise. wECG Module and Lead Cable ThewECGmoduleandleadcableareintendedforpatientuseswhencontinuousECGmonitoring orcardiacgatingarerequired.ThewECGmoduleandleadcablemaybeusedintheMRsystem bore,althoughthemodulemustnotbeplacedwithintheMRIfieldofview(FOV). CAUTIONS If dropped, the wECG module must be verified for correct operation before use. Guard against the accidental ingress of liquid into the module, as measurements made by the device can be adversely affected. ExpressionMR200InstructionsforUseMonitoringECG41 NOTE Refer to your facility's biohazard procedure for disposal of ECG lead cables when they become unusable. Usually cables are disposed of as medical waste per facility procedures. Defibrillator Use TheMR200hasadefibrillationproofdegreeofprotectionthatallowsapatienttobe defibrillatedwhileconnectedtothewECGmoduleandleads.Whenusingadefibrillator,follow allprecautionsrelatedtoboththeMR200andthedefibrillatorequipment.Duringadefibrillation procedure,theECGwaveformwillsaturatethenrecoverinlessthan5secondsinaccordance withAAMI/ANSIEC13andIEC60601227. WARNINGS The patient connector inputs for all parameters are protected against the use of a defibrillator by internal circuitry when the recommended patient cables or accessories are used. Defibrillation and electrosurgery: Do not touch the patient, or table, or instruments, during defibrillation. The MR200 can be used in the presence of defibrillators or electrosurgery units, provided the equipment being used is in good working order, meeting appropriate safety standards, is properly grounded and is operated correctly in the appropriate manner and environment. Improperly grounded equipment can be a safety hazard and can also cause interference to the ECG signal and result in a noisy ECG signal waveform and inaccurate heart rate measurements. CAUTION When using a defibrillator, do not introduce discharges of 360 joules or more, repeated five times over 5 minutes. Read the safety instructions provided with the defibrillator. The MR200 Cart is designed to withstand defibrillation and will recover within 5 seconds (per IEC 60601-1, Requirements for the Safety of Medical Electrical Equipment), and IEC 60601-2-49, Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment). 42MonitoringECGExpressionMR200InstructionsforUse Patient Preparation for ECG Monitoring WhenmonitoringECG,thesiteselectedonthepatient,theQuadtrodeelectrodeandECGlead cable,thefilterandleadviewsettingofthemonitor,andtheambientenvironmentwillimpact theperformanceandoperationoftheparameter. ECG Site Considerations MonitoringECGintheMRenvironmentisparticularlychallengingbecauseoftheinherent distortionoftheECGwaveformcausedbytheMRmagneticfield.Thesebloodflowinduced distortionsoftheECGareduetothelargeamountofbloodmovingthroughthevesselsofthe heart(aorta).Blood(a verygoodelectricalconductor)movingthroughthelargemagneticfieldof theMRproducesanelectricalpotentialthataddstotheECGsignal.Thisinducedelectrical potentialisseenprimarilyasanaugmentationoftheECGTwaveamplitude,althoughothernon specificwaveformchangesarealsoapparentontheECG.SinceanelevatedTwaveorST segmentwillbeassociatedwithtruephysiologicdisorders,thestaticmagneticfieldinduced ECGdistortionswillbeproblematic.Forthisreason,abaselinerecordingoftheECGpriorto placingthepatientinsidetheMRmagnetroomwillbenecessary.Theproperplacementofthe ECGelectrodesintheMRIiscriticaltoreducingthebloodflowinduceddistortionoftheECG waveform.WithproperstrategicplacementoftheECGelectrodesandminimizationofthelead cablelength,thisbloodflowinduceddistortioncanbekepttoaminimum.Followingthe instructionsprovidedonthespecificQuadtrodefoilpackagingwillminimizethebloodflow induceddistortionontheECGsignal.Additionalartifactscausedbythestatic,gradientandRF electromagneticfieldscanseverelydistorttheECG,makingobservationofthemorphologic changesanddetectionofarrhythmiaquitedifficult.MonitoringadifferentECGlead(I,II,III,AVL, AVR,AVF)willminimizesomeoftheseartifacts. ECG Quadtrode Electrode Types OnlyusespecifiedQuadtrodeelectrodeswiththeMR200asthiswillminimizethepossibleriskof ECGelectrodeandcableheatingduringMRIprocedures,andreducetheamountofMRI generatedartifactsontheECGwaveform.ThreeQuadtrodeelectrodetypesareavailabletomeet thedifferentpatientandECGperformanceneeds:
QuadtrodeMRIECGPAD(REF989803179031)forgeneralMRIproceduresforadultsand pediatricpatientsweighingmorethan10kg(22pounds). ELCTRD,MRIECG,CV(REF989803179041)forcardiovascular(CV)MRIprocedures. ELCTRD,MRI,NEO(REF989803179051)forgeneralMRIproceduresforinfantsand neonatalpatientsweighinglessthan10kg(22pounds). ExpressionMR200InstructionsforUseMonitoringECG43 Selecting the Quadtrode Electrode and ECG Lead Cable ECGleadcablesarespeciallyconstructedtoavoidpatientheatingbyreducingtheamountof radiofrequency(RF)energythatcanflowthroughthewires.Suggestedapplicationsandthe recommendedleadcable(forpartnumbers,seepage126)andelectrodepairingsareprovided below. Cable,4LD,MRIECGwithQuadtrodeelectrode(REF989803179031):
Forallpatientsweighingover22pounds(10kg) Usewithallscansexceptcardiovascularscans Cable,4LD,CVMRIECGwithQuadtrodeelectrode(REF989803179041):
ProvidesthebestECGperformanceforallprocedures Worksbestonfemalesandoverweightpatients Cable,4LD,NEO.MRIECGwithQuadtrodeelectrode(REF989803179051):
Designedforinfantsandneonatesweighingunder22pounds(10kg) Forsedationandgeneralanesthesiaapplications Cable,AdvancedFilterECGwithQuadtrodeelectrode(REF989803179041):
DesignedtominimizethegradientartifactontheECGtrace Cable,AdvancedAppsECGwithQuadtrodeelectrode(REF989803179041):
Designedtoallowforwideelectrodeplacement Selecting the Quadtrode Electrode Placement Site Foroptimalperformance,usetheillustrationsbelowasplacementguidelineswhenapplyingthe Quadtrodeelectrodetothepatient. NOTE In the illustrations below, an imaginary nipple line is denoted by the horizontal axis. 44MonitoringECGExpressionMR200InstructionsforUse Selectingsitesonadultfemalepatients Averageweightadultfemale Overweightadultfemale CVQuadtrode(preferred) CVQuadtrode(preferred) StandardQuadtrode StandardQuadtrode Selectingsitesonadultmalepatients Averageweightadultmale Overweightadultmale CVQuadtrode(preferred) CVQuadtrode(preferred) StandardQuadtrode StandardQuadtrode ExpressionMR200InstructionsforUseMonitoringECG45 Selectingsitesonpediatricpatients Pediatricfemale Pediatricmale CVQuadtrode(preferred) CVQuadtrode(preferred) StandardQuadtrode StandardQuadtrode Selectingsitesoninfantsandneonatalpatients InfantsandNeonates StandardQuadtrode NeonatalQuadtrode*
*Forpatientsweighinglessthan22pounds(10kg) 46MonitoringECGExpressionMR200InstructionsforUse Preparing the ECG Site Toprepareanelectrodesiteonapatient Step 1 2 3 4 5 6 Action ChecktheexpirationdateoftheQuadtrodeelectrodepackage. Ifnecessary,shavetheapplicationareatoremovehairfromthe selectedelectrodesite(s). ApplyECGSkinPrepGel(REF989803152291)toagauzepad. Brisklyrubtheselectedsite(s)withthegauzepad(theskinmay turnpink). Removeanyexcessgelwithacleangauzepad. FollowtheplacementinstructionsprovidedoneachQuadtrode package.(Alsoreferencetheillustrationsabove.) NOTES The ECG Skin Prep gel contains light abrasive pumice and saline that clean and enhance the conductive properties of the skin, thus enhancing ECG performance. This practice also helps remove ambient artifacts, such as the 50/60 hertz noise generated by the MR environment. Isopropyl/rubbing alcohol must not be used to prep the site as it breaks down the conductive properties of the skin, thus degrading ECG performance. Checking Electrode Contact Quality ProperQuadtrodeelectrodepreparationiscriticaltoECGperformance.Theresultofpoor electrodepreparationwillbepoorECGmonitoringperformance.Ifelectrodecontactispoor, thenremoveanddiscardtheelectrode,andrepeatthesitepreparationprocessaccordingtothe instructionsabove.Neverreuseanelectrodeasitsadhesivewillnotsecurelyfastentotheskin. ExpressionMR200InstructionsforUseMonitoringECG47 Attaching the Lead Cable Designatorsontheleadcablereferenceplacesonthetorsowheretheelectrodesshouldreside inrelationtothepatientsextremities.However,dependinguponthecabletype(IECorAHA), therespectivecablesusedifferentdesignatorsandcolorstoreferenceleadplacement. WARNINGS Never use any ECG lead cables other than the specified ECG lead cables. High levels of RF energy may cause patient heating or burns. Lead cables that become inadvertently looped during an MRI examination may act as conductive lines for RF induced currents, resulting in excessive heating and possible burns. When lead cables or other cables form a conductive loop in contact with the patient's tissue, minor to severe burning can result. Please refer to the additional information in Appendix D to prevent excessive heating associated with MRI procedures. Follow steps to minimize the risks of MRI-related heating on page 4-12. Limb Right arm Right leg Left arm Left leg AHA Lead Designator, Color IEC Lead Designator, Color RA, White RL, Green LA, Black LL, Red R, Red N, Black L, Yellow F, Green TheconnectiondiagramsbelowillustrateplacementofeachtypeofECGleadcable. AHA Lead Cable Connections IEC Lead Cable Connections CAUTION ECG clip leads should not be placed on the patients extremities. 48MonitoringECGExpressionMR200InstructionsforUse ToattachtheleadcabletothewECGmoduleandleadcableclipstotheQuadtrodeelectrode Step 1 Action Alignthecolorcodingonthe leadcableconnector(A) withcolorcodingonthe wECGmodule(B)then inserttheconnectorintothe module.(AnAHAleadcable isshownintheexample.) A B CAUTION When inserting or removing the lead cable or clip leads, only use the connector or clip; never pull or apply excessive force to the wires. 2 DependinguponthetypeoftheECGleadcableandreferencingthe diagramsonpage48,attachtheECGclipleadstotheQuatrode electrode. AHA lead cable IEC lead cable RL LL F N RA LA L R 3 4 Keepthemoduleoutsidethefieldofview(FOV)byplacingitinone ofthetwolocationsshowninPositioningthewECGModuleand LeadCableforScanningonpage411. Checkthestatusindicatorofthemodule;seepage28:
Solidgreen=Batterypowergood/Goodcommunication Flashinggreen=Batterypowergood/Nocommunication Solidred=Lowbatterypower/Goodcommunication Flashingred=Lowbatterypower/Nocommunication ExpressionMR200InstructionsforUseMonitoringECG49 Lead Failure Indication IfadisconnectedorfaultyQuadtrodeelectrodeorECGleadisdetectedduringmonitoring,the systemwillimmediatelynotifyyousothatquickactioncanbetakentoidentifythesourceofthe failureandproceedwithaninformedresponse.Asshownintheexamplebelow,LEADFAILwill bedisplayedandaredLeadFailindicatorwillappearintheECGVSboxidentifyingthespecific location(LL,LA,orRA);seepage918fortroubleshootinginformation. Warning WARNING Failure to respond to a Lead Fail alarm will result in a lapse of patient monitoring. LEAD FAIL message NOTE If the RL electrode has lost contact (or if all electrodes have lost contact) then LL, LA, RA will be the displayed indication. LEAD FAIL indicator
(Example, left arm) 410MonitoringECGExpressionMR200InstructionsforUse Positioning the wECG Module and Lead Cable for Scanning WARNINGS When applying electrodes or connecting the patient lead cable, ensure that the electrodes or connectors never contact other conductive materials including grounded conductors. In order to prevent contact with other conductors or earth ground, make sure all the electrodes or connectors are properly attached to the patient. No other electrical conductors (e.g. wires, leads, probes, etc.) should be placed within the MRI bore at the same time as the ECG lead wires. Electrode heating risk increases when multiple conductive cables and sensors are placed in the bore with the patient. Mixing of conductors from various manufacturers (catheters, temperature sensors, etc.) is not recommended. Multiple electrical conductors within the MRI bore can allow cross-coupling between these various conductors, and appear as a large antenna for RF energy pick-up, which will result in electrode heating, and possibly skin burns. It is always important to identify if the patient has any metallic wires, conductors, implants, stents, etc. within their body which will act as cross-coupling conductors. If these are present, ECG monitoring may not be able to be performed without experiencing electrode heating. Non-conductive tubes, air-lines, etc.including NiBP cuffs and hoses, EtCO2 and/or oxygen air-lines, and SPO2 sensorscan be used safely as these items do not include electrically conductive materials. The MR200 has been validated for use with all accessories specified in the accessory list. Circular, U-shaped or S-shaped loops in the patient lead cable should be avoided to reduce the risk of heating. ThewECGmodulemaybeusedintheMRsystembore,althoughthemodulemustnotbeplaced withintheMRIfieldofview(FOV). LeadcablesmustalwaysbekeptinastraightlineandmustnottouchtheMRsystembore.Any loop(circular,Ushaped,Sshaped)inthecablesorcablecontactwiththeMRsystemborewill causeheatinginthecablesorinthepatientelectrodes.Followthestepsbelowtominimizethe cableheatingrisk. ExpressionMR200InstructionsforUseMonitoringECG411 NOTE Follow these guidelines to ensure the best possible performance of the wECG module, especially during harsh scan sequences (with PNS-peripheral nerve stimulation-levels above 80 percent):
1. Place the modules on or near the patient as close to the bore iso-center as possible
(considering the scan to be performed). 2. Keep the wireless module outside the field of view. 3. Place the modules as close to the bore opening as possible. (If the modules can be placed outside the bore, positioning at the bore iso-center is not necessary.) 4. Place the modules on a cushioned surface to minimize MR vibrations. Warning WARNING If the wECG module is positioned incorrectly when used within the MR magnet room, the following factors may cause ECG waveform distortion and numeric inaccuracies:
Fast magnetic field changes usually found with, but not limited to, scan sequences using Peripheral Nerve Stimulation (PNS) levels above 80 percent. Severe vibrations induced by scan sequences using PNS levels above 80 percent. The distance from the bore iso-center in the x, y, or z directions. Minimizing the Risk of MRI-Related Heating CAUTION Placing the wECG module within the FOV may interrupt ECG monitoring during the MRI procedure and cause MRI image artifacts. TominimizetheriskofMRIrelatedheating Step 1 Action ArrangetheECGleadcableandtheclipleadsneatly,inastraight alignment,withnolooping. 2 3 4 Avoidcontactbetweencablesandbareskin. UseonlytheECGleadcablesdesignatedforusewiththisproduct;
seepage126. Minimizetheuseofmultiplecables.(Seethewarningsonpage4 11fordetails.) 412MonitoringECGExpressionMR200InstructionsforUse Step 5 6 7 8 Action ThewECGmodule,ECGleadcablesandQuadtrodeelectrodeare acceptableforusewithinMRsystemswithstaticmagneticfield strengthsof3.0TeslaorlesswithintheMRsystemboreusingaMR systemreportedwholebodyaverageSpecificAbsorptionRates
(SAR)upto4.0W/kg. MonitoringofECGatpowerlevelsofgreaterthanaMRsystem reported,wholebodyaveragedSARof4W/kgisnotrecommended forthegeneralpatientpopulation.Suchmonitoringmustonlybe attemptedwithconsciouspatientswithnormalthermoregulatory capabilitiessothattheymaywarnyouofpossibleexcessiveheatat themonitoringsites. Usecautionforscantimes(thatis,perpulsesequence)greater than15minutes.ForMRIscanswithaverageSAR>1W/kg,limit scantimeto15minutesandpauseatleast3minutesbetween scanstoallowtheECGelectrodestocool. Duringmeasurement,checkthepatienttoensurethatMRIrelated heatingisnotoccurring. Checking the ECG Signal Strength Aminimumsignalstrength(amplitude)shouldbepresent,assmallersignalsmaybeproneto gradientinterference.EvaluatetheECGsignalproducedbythepatientbeforeentryintotheMRI scanner,theoptimumtimetocorrectanyproblem. AproperECGsignalisdeterminedbythepeaktopeakamplitudeoftheQRScomplex.TheQRS complexshouldbeapproximately2millivoltsonthedisplay(thatis,thesignalshouldbetwice thesizeofthescaleindicator,a1mVreference,atanygivenSCALEsetting). Scale indicator QRS complex Selecting the Scale TheSCALEsettingonlychangeshowtheECGtraceappearsonthescreen,increasingor decreasingthewaveformandanyartifacts.ToincreasetheamplitudeoftheQRSComplex,see ChangingtheLeadViewonpage414. ExpressionMR200InstructionsforUseMonitoringECG413 TochangetheSCALEsetting Step 1 Action PressthePatientkey andthenselecttheappropriate 2 3 4 5 PATIENTtype;seepage310fordetails. TurnthecontrolknobtohighlighttheECGVSbox(seepage418) andthenpresstheknob. TheECGmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSCALEandthenpresstheknob. TheSCALEmenuappears;seepage421. Turntheknobtoselectthesettingandthenpresstheknob.Onlya settingof5mm/mVor10mm/mVisrecommended. AUTO 1mm/mV 5mm/mV 10mm/mV 15mm/mV 20mm/mV 25mm/mV 30mm/mV 40mm/mV Thesettingisapplied. Takenoteofthescaleindicator;seepage416.Iftheselectedscale resultsinanECGtracesolargethatthewaveformpeaksare distortedorclipped,OVERSCALEwillbedisplayed.Inthiscase, selectanothersettingtoresizethewaveformuntilthemessage stops. Changing the Lead View IftheQRSComplexdoesnotequalaminimumof2mV,thencompletethefollowingsteps. Tochangetheleadview Step 1 2 Action VerifytheQuadtrodeelectrodedate,qualityandpackaging. EnsurethatthepreferredQuadtrodeelectrodeandplacement site(s)arebeingused;seepage44. 414MonitoringECGExpressionMR200InstructionsforUse Step 3 Action TurnthecontrolknobtohighlighttheECGVSbox(seepage418) andthenpresstheknob. 4 5 6 7 TheECGmenuappears.Currentsettingsaredisplayed. Dependinguponthetracebeingexamined,turnthecontrolknobto TRACEALEADorTRACEBLEADandthenpresstheknob. Therespectivemenuappears;seepage420or420. Changethesettingtoadifferentleadviewtoaccountforpatient variabilityandthenpresstheknob. I II III AVL AVR AVF Theleadviewchanges;seepage416. NOTE When presented with a low QRS amplitude from ECG or poor gating, it may be necessary to use the PEDIATRIC ECG setting;
see page 3-11. Iftheamplitudedidnotimprove,cyclethroughtheremaininglead viewstoafindthebestsignalamplitudebyrepeatingstep5. Iftheamplitudedoesnotimprove,removetheleadcableand Quadtrodeelectrodeandthenpreptheapplicationsiteagain. Selecting the Filter Mode ChoosetheappropriateECGfiltermodeforyourMRIstudy. Tochangethefiltermodesetting Step 1 Action TurnthecontrolknobtohighlighttheECGVSbox(seepage418) andthenpresstheknob. TheECGmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoFILTERMODEandthenpresstheknob. 2 TheFILTERMODEmenuappears;seepage423. ExpressionMR200InstructionsforUseMonitoringECG415 Step 3 Action Turntheknobtoselectthefilterandthenpresstheknob. MONITOR PRIMARY SECONDARY CARDIAC ADVANCED Thesettingisapplied,asindicatedabovetheECGVSbox. ECG Waveforms and VS Box TheelementscontainedinthedisplayedECGwaveform(TraceA,andBifenabled)andVSbox aredescribedbelow:
12 13 14 15 11 10 9 8 1 2 3 4 7 6 5 Definition 1 2 3 4 5 6 7 8 9 10 11 12 Is the high limit setting of the HR (heart rate) alarm; see page 4-19 Is the heart rate measurement (numeric) Is the low limit setting of the HR alarm; see page 4-19 Is the unit of measure for the heart rate, where BPM is beats per minute Is the selected HR SOURCE; see page 4-22 Is the name of the vital sign Is the detected ECG Trace B waveform Is the scale indicator, a 1-millivolt signal reference (see SCALE on page 4-21) Is the selected TRACE B LEAD; see page 4-20 Same as 8, above Is the selected TRACE A LEAD; see page 4-20 Displays LEAD FAIL when detected; see the example on page 4-10 416MonitoringECGExpressionMR200InstructionsforUse Definition 13 14 15 Is the detected ECG Trace A waveform Displays messages; see page 9-16 for details Is the selected FILTER MODE; see page 4-23 Changing the Waveform Speed TochangetheECG(andSPO2)waveformspeed Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurntheknobtoSWEEPSPEEDandthenpresstheknob. TheSWEEPSPEEDmenuappears;seepage314. Turnthecontrolknobtoselecteitherofthefollowingsettingsand thenpresstheknob:
50mm/s 25mm/s Theselectionisentered. Changing the Heart Rate Alarm Limits Tochangetheheartratealarmlimitsettings Step 1 Action TurnthecontrolknobtohighlighttheECGVSbox(seepage418) andthenpresstheknob. TheECGmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoALARMLIMITSandthenpresstheknob. TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;
seepage419fordetails. Turntheknobtotheloworhighsettingandthenpresstheknob. 2 3 Thesettingisselected. ExpressionMR200InstructionsforUseMonitoringECG417 Step 4 Action Turntheknobtochangethesettingvalueandthenpresstheknob tomakethechangeeffectiveandreturntothescrollingfunction. Thesettingischanged. 5 Tochangetheremainingsetting,repeatsteps3and4. NOTE To make global changes to the parameter alarm limit settings based upon the patients current vital sign readings, see Setting Alarm Limits Globally on page 9-4. ECG Menu TheECGmenuallowsyoutocontrolECG traces,functionsandsettings. TochangesettingsintheECGmenu Step 1 Action TurnthecontrolknobtohighlighttheECGVSboxandthenpress theknob. TheECGmenuappears.Currentsettingsaredisplayed. 418MonitoringECGExpressionMR200InstructionsforUse Step 2 Action TurnthecontrolknobtoselectanyofthefollowingECGoptions:
ALARMLIMITS TRACEALEAD TRACEBLEAD SCALE GATINGSOURCE HRSOURCE HRTONESOURCE FILTERMODE ECGTESTSIGNAL TWAVESUPPRESSION MAGNETCONTROL Forinformationabouttheseoptions,seetheappropriatesections below. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeothersettings,repeatsteps2and3. PresstheMainkey toclosethemenu. 3 4 5 Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. ALARM LIMITS Controlsthealarmlimitsettingsforheartrate.(Seethetableonpage915foralisting.) 5 4 3 2 1 Definition 1 2 3 Is the setting of the high alarm limit Is the current measurement Is the setting of the low alarm limit ExpressionMR200InstructionsforUseMonitoringECG419 Definition 4 5 Saves the settings then returns to the normal mode Identifies heart rate alarm limits Tosetanalarmlimitforheartrate SeeChangingtheHeartRateAlarmLimitsonpage417. TRACE A LEAD SetstheECG A leadconfiguration.ForbestECGandheartratemonitoring,alwaysselectthe optimalleadconfiguration,theonethatprovidestheleastartifactandlargestwaveform detectionformonitoringuse. Thefollowingchoicesareavailable:
I II(Default) III AVL AVR AVF OFF TosettheECGAlead SeeChangingtheLeadViewonpage414. TRACE B LEAD SetstheECG B leadconfiguration,allowingyoutoviewtwoECGwaveformssimultaneously. Thefollowingchoicesareavailable:
I II III AVL AVR AVF OFF(Default) 420MonitoringECGExpressionMR200InstructionsforUse TosettheECGBlead SeeChangingtheLeadViewonpage414. SCALE SetsthescalefortheECG waveforms.Aftermakingthissetting,takenoteofthescaleindicator;
seepage416.Iftheselectedscaleresultsinawaveformwithdistortedorclippedpeaks, OVERSCALEwillbedisplayedandanothersettingshouldbeselecteduntilthemessagestops. Thefollowingchoices(inmillimeterspermillivolt)areavailable:
AUTOmakesthewaveformfilltheECGtracearea(notrecommendedforuseintheMR). 1mm/mV 5mm/mV 10mm/mV(Default) 15mm/mV 20mm/mV 25mm/mV 30mm/mV 40mm/mV TosettheECGscale SeeSelectingtheScaleonpage413. NOTE This setting does not affect the signal analyzed by the monitor for QRS detection and ECG gating. GATING SOURCE Setsthecardiacgatingsourcebasedonameasuredsignal.(Thisisthesameoptionasinthe SPO2menu.) Thefollowingchoicesareavailable:
ECGareoutputsthatrepresentthedetectionoftheRpeakofaQRScomplex,asignalthe MRsystemcanusedirectlyfortriggering.(Default) PULSEaresignalsthatrepresentthedetectionofthepeakoftheperipheralpulsecomplex. Tosetthegatingsource SeeUsingtheGatingFeatureonpage426. ExpressionMR200InstructionsforUseMonitoringECG421 NOTE Trace A is the default output channel for interfacing the cardiac gating input. To use Trace B, set Trace A to off, and ensure that Trace B is active (that is, not off); see page 4-20. HR SOURCE Selectsthesourcethatproducestheheartrate,asdisplayedintheECGVSbox(identicaltoand interactivewiththesameoptionintheSPO2menu). Thefollowingchoicesareavailable:
AUTOselectsthesourceautomaticallyfromthehighestpriorityactiveinput,wherethe MR200searchesforanothersourceonlywhenLEADFAILoccursorwhenECGisoff.Ifthe highestpriorityinputisnotfound,thenextrankedparameterissought.Thepriority rankingisECGandthenSPO2.Ifnoparameterspresentaheartrate,thenNONEis displayedintheheartrateposition. ECG(Default) SPO2 Tosettheheartratesource Step 1 Action TurnthecontrolknobtohighlighttheECGVSbox(seepage418) andthenpresstheknob. 2 3 TheECGmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoHRSOURCEandthenpresstheknob. TheHRSOURCEmenuappears. Turnthecontrolknobtoselectoneofthefollowingoptionsand thenpresstheknob:
AUTO ECG SPO2 Thesettingischanged. HR TONE SOURCE Setsthesourceusedfortheheartratetone(identicaltoandinteractivewithsameoptioninthe MONITOR>SOUNDADJUSTmenuandintheSPO2menu). 422MonitoringECGExpressionMR200InstructionsforUse Thefollowingchoicesareavailable:
OFFremovestheheartsymbolfromthedisplayandnopulsetonewillbesounded.
(Default) QRSprovidesatonetriggeredbytheQRSdetectionfromtheECGvitalsign. SPO2providesatonemodulatedbytheSPO2vitalsign,wherethelowertheSPO2value, thelowerthepitch. Tosettheheartratetonesource EntertheECGmenu.TurnthecontrolknobtoHRTONESOURCEandpresstheknob.Scrolltothe desiredsettingandpresstheknob.(Seepage39fordetailedinstructions.) FILTER MODE SetsthefilteringmodefortheECGsignal. NOTES Due to the variety of MRI sequence characteristics, if the filter recommendations below do not provide optimum performance in all cases, the selection of another filter mode may improve ECG performance. ECG performance can be affected by electrode placement, the MRI procedure, the image slice angle and slice thickness. In situations where ECG performance is not optimal, select the ECG lead (I, II, III, AVL, AVR, or AVF) that provides the best performance. For cases not requiring cardiac gating, start with the Primary filter mode (depending on the MRI sequence) and switch filters if a gradient artifact is noticed. If a gradient artifact is still present, check signal strength and try lead I or III. Thefollowingchoicesareavailable:
MONITORprovidesfilteringcharacteristicsthatmeetthespecificationoftheAssociation fortheAdvancementofMedicalInstrumentation(AAMI).Notethatthisfilterwillnot provideoptimumperformanceduringactiveMRIsequences. PRIMARYprovidesthebestpossibleperformanceon0.15to3.0TMRsystemsduringEcho TraintypeMRIsequences.(Default) SECONDARYprovidesthebestpossibleperformanceon0.15to3.0TMRsystemsduring mostnoncardiovascularMRIsequences. CARDIACprovidesthebestpossibleperformanceduringcardiovascular(CV)MRI proceduresthatinvolvesteadystatefreeprecessionimagingwithbalancedgradient(True FISP,FIESTA,orBalancedFFE)sequenceson1.5and3.0TMRsystems.Forcasesrequiring cardiacgating,startwiththeCardiacfilterinleadIIandswitchfiltersifgradientartifactis noticed.Ifgradientartifactisstillpresent,checksignalamplitudeandtryleadIorIII. ADVANCEDprovidesthebestpossibleperformanceon1.5and3.0TMRsystemsduring MRIsequencessuchasneurologicalandcardiovascular.ThisMRIfilterutilizesanadaptive filterschemeforremovalofgradientartifactgeneratedbyMRsystems. Bestperformance ExpressionMR200InstructionsforUseMonitoringECG423 isachievedusingtheAdvancedFilterECGleadcable,whichallowsplacementofthewECG moduleoutsideofthebore. Advancedfilteringoperatesononeleadatatimefromarestrictedsetofleadsandcannot beappliedtoAVR,AVLorAVFleads.Toprovidethemostconvenienttransitiontothis filterandleadconfiguration,thesystemwillautomaticallyselecttheleadtouseby applyingthefollowingrulesintheordershownbelow:
1. 2. 3. IfTraceAisdisplayed,thecurrentlyselectedleadonTraceAwillbeusedbutonlyifit isleadI,IIorIII. IfTraceBisdisplayed,thecurrentlyselectedleadonTraceBwillbeusedbutonlyifit isleadI,IIorIII. Ifneitherrule1norrule2apply,thenleadIIwillbeused. ThesystemdisplaystheselectedleadonTraceAanddisablesdisplayofTraceB.Youcan changewhichleadisfiltered,whiletheADVANCEDfilteroperatesbychanginglead selectionforTraceA.However,onlyleadsI,IIandIIIwillbeavailablewhiletheADVANCED filterisengaged.(TodeselectADVANCED,selectadifferentfilteroptionfromthemenu. Thedisplaywillremainunchanged;however,TraceBcanbereenabledatthispointif desired.) Tosetthefiltermode SeeSelectingtheFilterModeonpage415. ECG TEST SIGNAL GeneratesanECGcalibrationwaveform. Thefollowingchoicesareavailable:
OFFturnsthecalibrationfeatureoff.(Default) PRINTERsendsa1mVpulsecalibrationwaveformtotheECGvitalsignandalsotothe printer,ifsoconfigured,whereECGTESTSIGNALwillbeprintedbelowthewaveform. ECGsendsawECGmodulegenerated1mVpeaktopeakcalibrationsquarewavetothe ECGvitalsignandalsototheprinter,ifsoconfigured,whereECGTESTSIGNALwillbe superimposedoverthewaveformand60BPMwillbedisplayedintheECGVSbox. TogeneratetheECGtestsignal EntertheECGmenu.TurnthecontrolknobtoECGTESTSIGNALandpresstheknob.Scrolltothe desiredoutputandpresstheknob. NOTES Available on all lead configurations, except Lead III. Unavailable when FILTER MODE is set to ADVANCED. Automatically set to off during interoperability; see GATING SOURCE on page 4-21. 424MonitoringECGExpressionMR200InstructionsforUse T-WAVE SUPPRESSION ReducestheTwaveamplitudewhenextremelylargeduetothemagnetohydrodynamiceffect
(MHD),whichcanpreventgating.UseforaccurategatingwhenanunusuallyhighTwave amplitude,relativetotheRwaveamplitude,isseen. Thefollowingchoicesareavailable:
OFF(Default) ON ToapplyTwavesuppression EntertheECGmenu.TurnthecontrolknobtoTWAVESUPPRESSIONandpresstheknob.Scroll tothedesiredsettingandpresstheknob. NOTES Unavailable when FILTER MODE is set to MONITOR; see page 4-23. Controlled by the gating box through the wECG module during interoperability; see GATING SOURCE on page 4-21. With the wBTU, T-WAVE SUPPRESSION will be set to off; and, with other OEM gating boxes, it will be set as it is in the gating box. MAGNET CONTROL RemovesgradientartifactsoncertainMRsystemsequippedwithvectorECG gating.Onthesesystems,onlyonewECGmoduleneedstobeconnectedto thepatientinorderfortheMR200andtheMRsystemtomonitorthe patient'svitalsignsandgatethemagnet. Thefollowingchoicesareavailable:
AUTOMODEallowstheMRsystemtowork,ifcapable,withtheMR200 toeffectivelyremovegradientartifactsfromtheECGwaveform.When selectedandwiththewECGmoduleinradiocontactwiththeMR system,FILTERMODE,TWAVESUPPRESSIONandECGTESTSIGNAL willbedisabledandlocked.(Default) MAGNETCONTROLwillbedisplayedtoindicatethatfiltermode selectionhasbeenpreemptedbytheMRsystem.Inaddition,ifHR SOURCEissettoECG,theheartrateasderivedfromtheMRsystemwill bedisplayed(abriefinterruptioninthedisplayedwaveformispossible) andMAGNETFILTERwillbedisplayed. IftheMR200orthewECGmoduleceaseradiocontactwiththeMR system,theMR200willresetitsfilterandTwavesuppressionoptions tothesettingsheldpriortocontactwiththeMRsystem. ExpressionMR200InstructionsforUseMonitoringECG425 NOTE FILTER MODE and T-WAVE SUPPRESSION settings will not be recalled when in MAGNET CONTROL or MAGNET FILTER mode. And, if a system recall is performed and then the MR200 is moved from the MR environment, the filter and T-wave suppression options will revert to their previous settings. DISABLEDallowstheMR200tocontrolfilteringandTwavesuppression. Toallowmagnetcontrol EntertheECGmenu.TurnthecontrolknobtoMAGNETCONTROLandpresstheknob.Scrollto thedesiredsettingandpresstheknob. Using the Gating Feature ThegatingfeatureprovidesfacilitiesforlowlatencyMRItriggeringandsynchronizationbasedon themeasuredECGorSPO2signal.DatameasuredandtransmittedbythewECGorwSPO2 moduleisprocessedbytheMR200andthenoutputfromthegatingconnector;seepage116for thelocation,andseepageA11forsignaldetails.(Signalscanalsotransmittedbytheoptional wBTU.) Using ECG Gating ToreceiveECGgatingsignals Step 1 Action VerifythewECGmodulestatusbycheckingthestatusindicator:
Solidgreen=BatterypowerOK/Goodcommunication Flashinggreen=BatterypowerOK/Nocommunication Solidred=Lowbatterypower/Goodcommunication Flashingred=Lowbatterypower/Nocommunication 2 Ensurethattheleadcableisproperlyattachedtothepatient;see AttachingtheLeadCableonpage48.
(ECGoutputsareenabledbydefault;seepage421.) 426MonitoringECGExpressionMR200InstructionsforUse Using SPO2 Gating ToreceiveSPO2gatingsignals Step 1 Action VerifythewSPO2modulestatusbycheckingthestatusindicator:
Solidgreen=BatterypowerOK/Goodcommunication Flashinggreen=BatterypowerOK/Nocommunication Solidred=Lowbatterypower/Goodcommunication Flashingred=Lowbatterypower/Nocommunication EnsurethattheSPO2attachmentisproperlyattached;seeApply ingtheSPO2AttachmenttothePatientonpage53. TurnthecontrolknobtohighlighttheSPO2VSbox(seepage57) andthenpresstheknob. TheSPO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoGATINGSOURCEandthenpresstheknob. TheGATINGSOURCEmenuappears;seepage512. TurntheknobtoPULSEandthenpresstheknob. Thesettingisapplied. 2 3 4 5 ExpressionMR200InstructionsforUseMonitoringECG427 428MonitoringECGExpressionMR200InstructionsforUse CHAPTER 5 Monitoring SPO2 ThepulseoximetryfeatureusesamotiontolerantsignalprocessingalgorithmbasedonFourier ArtifactSuppressionTechnology(FAST)toprovideoxygenatedhemoglobinmeasurements,a visualpulseindicationandapulserate,specifically:
Oxygensaturationofarterialblood(SPO2):Thepercentageofoxygenatedhemoglobinin relationtothesumofoxyhemoglobinanddeoxyhemoglobin(functionalarterialoxygen saturation). Plethysmography(pleth)waveform:Avisualindicationofthepatientspulsatileblood flow. Pulserate(asderivedfromtheplethwaveform):Thenumberofdetectedpulsationsper minute. NOTE A pulse oximeter should be considered an early warning device. As a trend toward patient deoxygenation is indicated, blood samples must be analyzed by a laboratory co-oximeter to understand the patients condition completely. wSPO2 Module, Sensor and Attachment ThewSPO2module,sensorandattachment(cliporgrip)areintendedforpatientuseswhen continuousnoninvasivearterialoxygensaturation,pulseratemonitoringorpulsegatingare required.ThewSPO2module,sensorandattachmentmaybeusedintheMRsystembore, althoughthemodulemustnotbeplacedwithintheMRIfieldofview(FOV). CAUTION If dropped, the wSPO2 module must be verified for correct operation before use. NOTE Refer to your facility's biohazard procedure for disposal of SPO2 attachments and sensors when they become unusable. Usually sensors are disposed of as medical waste per facility procedures. ExpressionMR200InstructionsforUseMonitoringSPO251 Patient Preparation for SPO2 Monitoring WhenmonitoringSPO2,thesiteselectedonthepatient,theSPO2attachment,theattachments positiononthepatient,andtheambientenvironmentwillimpacttheperformanceand operationoftheparameter. Selecting the Site and Attachment Whenapplyingtheclipsorgripstothepatient,sitepreparationandthepressureandalignment oftheattachmentareimportantfactorstoconsider.Selectthemostappropriatelimbthatbest fitstheattachmentsize.Formeasurementstobeaccurateandreliable,theoptimumfitis reachedwhenthefiberheadwindowsopposeeachotherandarecoveredbyskinornail.Refer totheinstructionsprovidedwiththeattachmentwhenselectingandconnectingthecliporgrip. Attaching the Clip or Grip to the SPO2 Sensor Toattachtheclips(orgrips)totheSPO2sensor SnapthefiberheadsontheSPO2sensorintothe receptacles(windows)ontheSPO2attachment
(cliporgrip). SPO2 sensor Fiber heads SPO2 attachment (clip shown) 52MonitoringSPO2ExpressionMR200InstructionsforUse Applying the SPO2 Attachment to the Patient ReadthewarningsbeforeapplyinganSPO2attachmenttothepatient. WARNINGS General fit: If a clip or grip is too loose, it might compromise the optimal alignment or dislocate. If the clip or grip is too tight (for example, if the application site is too large or becomes large due to edema), excessive pressure may be applied resulting in venous congestion distal from the application site, which could lead to interstitial edema, hypoxemia, tissue malnutrition, and inaccurate measurements. Skin irritations may occur as a result of the clip or grip being attached to one location for too long. Periodically inspect the clip or grip application site and change the application site at least every 4 hours. Exercise care when using tape to secure the clip or grip, as the stretch memory properties of most tapes can apply unintended pressure to the site easily. Extremities to avoid: Avoid placing the clip or grip on extremities with an arterial catheter, intravascular venous infusion line, or inflated blood pressure cuff. Failure to do so may result in inaccurate readings or false alarm indications. Protect the sensor from contact with any liquid. If the sensor, clips or grips show signs of damage like exposed fibers, replace the part immediately. Do not use damaged equipment. Keep detached grips and clips away from small children to avoid possibility of swallowing. Toapplyareusablecliptothepatient Step 1 2 3 4 5 Action Selecttheapplicationsite.Itshouldmatchtheclipsizesothatthe sensordoesnotfallofforapplyexcessivepressureatthesite. Ifpresent,removeanycolorednailpolishfromtheapplicationsite. Pressthecliptoopen. Pushtheclipoverafingersoeither fiberheadisonthetopovertheroot ofthenailandtheotherfiberhead oppositetoit.(Itdoesnotmatter whichheadisontop.) Ensurethatthefingeristouchingthestopatthecushionandlays nicelycenteredintheclip. ExpressionMR200InstructionsforUseMonitoringSPO253 Toapplyadisposablecliptothepatient Step 1 2 3 4 5 6 Action Selecttheapplicationsite.Itshouldmatchtheclipsizesothatthe sensordoesnotfallofforapplyexcessivepressureatthesite. Ifpresent,removeanycolorednailpolishfromtheapplicationsite. Liftoffthereleaselinersthatprotecttheadhesive. Putthefinger(ortoe)ontoeithersideoftheattachmenttheyare symmetricalsuchthatthetipcoversthewindowcompletelyand doesnotprotrudeoverthehinge. Closethegrip.Ifthefitisgood,presstheattachmentfirmlyonthe fingerortoe.Ifthefitisnotgood,repositiontheattachment.Make surethelimbiscenterednicelyintheattachment. Wrapthefoamwingsaroundthe fingerandattachmentandstickto theopposinggripside.Donotstretch thefoamtoapplyexcessivepressure. Toapplyadisposableneonatecliptothepatient Step 1 2 3 4 5 Action Selecttheapplicationsite.Itshouldmatchtheclipsizesothatthe sensordoesnotfallofforapplyexcessivepressureatthesite. Liftoffthereleaselinersthatprotecttheadhesive. Proceedaccordingtotheapplicationsite:
Footapplication:Alignthehingeontheoutsidefacingridge ofthefoot.Makesuretheattachmentisasfaraspossible towardthesmalltoebutnotoverit. Hand/Wristapplication:Alignthehingeontheoutsidefacing ridgeofthehandorwrist.Youmayhavetoswivelthefiber headstoanoptimalpositiontoeasetheapplication. Withthehingealignedwiththeridgeofthefoot/hand/wrist,press onesidetotheskinandthenwraptheothersidearoundthelimb pullingthelongfoampiecegently. Pressbothfiberheadsgentlytoattach theadhesives. 54MonitoringSPO2ExpressionMR200InstructionsforUse Step 6 7 Action Securethelongerfoampiecebypressingitfirmlytothefoam/
adhesiveoftheopposingside. Ensurethatthetwofiberheadsareopposingandhavegoodskin contact.Theanglebetweenthetwofiberheadsshouldbeassmall aspossible,notexceeding45.Iftheattachmentopenstoomuch, reattachortryanothersite. WARNING Disposable attachments are designed for single patient use and must be disposed after use. They must not be cleaned and reused. Follow your hospitals guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. Positioning the wSPO2 Module for Scanning Toensurethebestperformance,specificpositioningconsiderationsarerequiredwhenusingthe wSPO2moduleintheMRmagnetroom,includingharshscansequenceswithperipheralnerve stimulationlevelsabove80percent. WARNING If the wSPO2 module is incorrectly positioned when used within the MR magnet room, the following factors can cause SPO2 waveform distortion and numeric inaccuracies, and respiration numeric inaccuracies:
Fast magnetic field changes usually found but not limited to scan sequences using PNS levels above 80 percent. Severe vibrations induced by scan sequences using PNS levels above 80 percent. Distance from the bore opening. Distance from the bore iso-center in the x, y, or z direction. ToensurebestperformanceduringSPO2measurements Step 1 2 Action Ensurethatthefiberheads(thelightemitterandthe photodetectorinthecliporgrip)aredirectlyoppositeeachother, asthelightmustpassthroughthepatientstissueandbereceived forproperoperation. Swiveleachfiberheadintoapositionthatcausestheleastbending ofthecablewhileprovidingthemostcomforttothepatient. ExpressionMR200InstructionsforUseMonitoringSPO255 Step 3 Action VerifythewSPO2modulestatusbycheckingthestatusindicator:
Solidgreen=BatterypowerOK/Goodcommunication Flashinggreen=BatterypowerOK/Nocommunication Solidred=Lowbatterypower/Goodcommunication Flashingred=Lowbatterypower/Nocommunication PressthePatientkey andthenselecttheappropriate PATIENTtype;seepage310fordetails. CheckforanydisplayedSPO2messagesand,ifamessageis present,followtherecommendedactiontoachievebetterresults
(seepage916). Whileconsideringthescantobe performed,placethewSPO2moduleonor nearthepatientandascloseaspossibleto theboreopening.Keepthesensorand moduleoutsidethefieldofview. Placethemoduleascloseaspossibletotheboreopening.(Ifthe modulecanbeplacedoutsidethebore,positioningattheiso centerisnotnecessary.) PlacethemoduleonacushionedsurfacetominimizeMR vibrations. Covertheattachmentsiteonthepatientwithopaquematerial. Duringmeasurement,checkthepatienttoensurethatthe applicationsitehasapulsatileflowandthatthesitehasnot changedinthickness(forexample,duetoedema)causingan improperfit. 4 5 6 7 8 9 10 56MonitoringSPO2ExpressionMR200InstructionsforUse SPO2 Waveform and VS Box TheelementscontainedintheSPO2waveform(TraceC)andVSboxaredescribedbelow:
5 6 1 2 3 4 Definition 1 2 3 4 5 6 Is the high limit setting of the SPO2 alarm; see page 5-10 Is the low limit setting of the SPO2 alarm; see page 5-10 Is the heart rate numeric and the unit of measure, where BPM is beats per minute. Is the name of the vital sign Is the detected SPO2 waveform, not proportional to pulse volume and can be amplitude-adjusted for viewing; see page 5-8. Is the SPO2 measurement (numeric), given as a percentage Changing the Waveform Speed TochangetheSPO2(andECG)waveformspeed Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurntheknobtoSWEEPSPEEDandthenpresstheknob. TheSWEEPSPEEDmenuappears;seepage314. Turnthecontrolknobtoselecteitherofthefollowingsettingsand thenpresstheknob:
50mm/s 25mm/s Theselectionisentered. ExpressionMR200InstructionsforUseMonitoringSPO257 Changing the SPO2 Waveform Amplitude TochangetheSPO2waveformamplitude Step 1 2 3 Action TurnthecontrolknobtohighlighttheSPO2VSbox(seepage59) andthenpresstheknob. TheSPO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSIZEandthenpresstheknob. TheSIZEmenuappears;seepage511fordetails. Turnthecontrolknobtoselectoneofthefollowingoptionsand thenpresstheknob:
10,20,40,60,80or100percent Thesettingischanged. Changing the SPO2 Alarm Limits TochangetheSPO2alarmlimitsettings Step 1 2 3 4 5 Action TurnthecontrolknobtohighlighttheSPO2VSbox(seepage59) andthenpresstheknob. TheSPO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoALARMLIMITSandthenpresstheknob. TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;
seepage510fordetails. Turntheknobtotheloworhighsettingandthenpresstheknob. Thesettingisselected. Turntheknobtochangethesettingvalueandthenpresstheknob tomakethechangeeffectiveandreturntothescrollingfunction. Thesettingischanged. Tochangetheremainingsetting,repeatsteps3and4. NOTE To make global changes to the parameter alarm limit settings based upon the patients current vital sign readings, see Setting Alarm Limits Globally on page 9-4. 58MonitoringSPO2ExpressionMR200InstructionsforUse Assessing Suspicious SPO2 Readings Pulseoximetrymeasurementsarestatisticallydistributed.Withneweralgorithms,suchasFAST SPO2,thecalculationofSPO2isnotdirectlylinkedtothecorrectdetectionofeachpulse.When thepulserateisveryloworastrongarrhythmiaispresent,theSPO2/plethysmographypulse ratemaydifferfromtheheartratecalculatedfromECG.Thisdoesnotindicateaninaccurate SPO2value.IfyoudoubtthemeasuredSPO2,usetheplethysmographywavetoassessthesignal quality. WARNINGS Always shield (for example, cover with opaque material) the SPO2 clip or grip from extraneous incidental light sources, as such light can cause erroneous SPO2 readings or pulse detection errors. SPO2 monitoring requires the detection of valid pulses to correctly determine SPO2 and heart rate values. Any of the following items can lead to inaccuracies of the SPO2 readings and/or prolonged measurement time: Ambient light (including photodynamic therapy), physical movement (patient and imposed motion), arrhythmias and/or erratic heartbeats, diagnostic testing, electromagnetic interference, electrosurgical units, dysfunctional hemoglobin, intravascular dyes, presence of dyes or pigments at the application site, and inappropriate positioning of the pulse oximeter attachment. If questionable readings are obtained, check the patients vital signs by alternate means before administering medication. Attachment movement, ambient light (especially strobe or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached to a patient. Bandage and grip attachment designs are particularly sensitive to minimal movement that might occur when the sensor is dangling, not attached to the patient. An unapplied sensor may cause readings to be displayed on the monitor. To avoid misdiagnosis, ensure the sensor is applied to patient correctly. SPO2 Menu TheSPO2menuallowsyoutocontrolSPO2functions andsettings. ExpressionMR200InstructionsforUseMonitoringSPO259 TochangesettingsintheSPO2menu Step 1 Action TurnthecontrolknobtohighlighttheSPO2VSboxandthenpress theknob. 2 3 4 5 TheSPO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoselectanyofthefollowingSPO2options andthenpresstheknob:
ALARMLIMITS SIZE AVERAGINGTIME GATINGSOURCE HRSOURCE HRTONESOURCE Forinformationabouttheseoptions,seetheappropriatesections below. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeothersettings,repeatsteps2and3. PresstheMainkey toclosethemenu. Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. ALARM LIMITS ControlstheSPO2alarmlimitsettings.(Seethetableonpage915foralisting.) 5 4 3 2 1 510MonitoringSPO2ExpressionMR200InstructionsforUse Definition 1 2 3 4 5 Is the setting of the high alarm limit Is the current measurement Is the setting of the low alarm limit Saves the settings and returns to the normal mode Identifies SPO2 alarm limits TosetthealarmlimitsforSPO2 SeeChangingtheSPO2AlarmLimitsonpage58. SIZE ChangestheverticalscaleoftheSPO2(pleth)waveformsothathighamplitudescanbescaled downtoavoidclippingofthepeaksandlowamplitudescanbescaleduptoviewthepeaks. Thefollowingchoicesareavailable:
10%
20%
40%
60%
80%
100%(Default) ToadjustthesizeoftheSPO2waveform SeeChangingtheSPO2WaveformAmplitudeonpage58. AVERAGING TIME Selectshowquicklythereadingrespondstochangesinthepatientssaturation,whereselecting alongerdurationwillpreventthesaturationvaluefromchangingquicklywhichcanbeusefulfor avoidingalarmtriggeringinpatientswithverydynamicconditionssuchasneonataland pediatrics. Thefollowingchoices(inseconds)areavailable:
5S 10S(Default) 15S ExpressionMR200InstructionsforUseMonitoringSPO2511 TosettheaveragingtimeoftheSPO2reading EntertheSPO2menu.TurnthecontrolknobtoAVERAGINGTIMEandpresstheknob.Scrollto thedesiredtimeandpresstheknob. GATING SOURCE Setsthecardiacgatingsourcebasedonameasuredsignal.(ThisisthesameoptionasintheECG menu.) Thefollowingchoicesareavailable:
ECGisanoutputthatrepresentsthedetectionoftheRpeakofaQRScomplex,asignalthe MRsystemcanusedirectlyfortriggering.(Default) Pulseisasignalthatrepresentsthedetectionofthepeakoftheperipheralpulsecomplex. Tosetthegatingsource SeeUsingtheGatingFeatureonpage426. HR SOURCE Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes
(identicaltoandinteractivewiththesameoptionintheECGmenu). Thefollowingchoicesareavailable:
AUTOselectsthesourceautomaticallyfromthehighestpriorityactiveinput,wherethe MR200searchesforanothersourceonlywhenLEADFAILoccursorwhenECGisoff.Ifthe highestpriorityinputisnotfound,thenextrankedparameterissought.Thepriority rankingisECGandthenSPO2.Ifnoparameterspresentaheartrate,thenNONEis displayedintheheartrateposition. ECGselectsECG.(Default) SPO2selectsSPO2. Tosettheheartratesource Step 1 Action TurnthecontrolknobtohighlighttheSPO2VSbox(seepage57) andthenpresstheknob. TheSPO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoHRSOURCEandthenpresstheknob. 2 TheHRSOURCEmenuappears. 512MonitoringSPO2ExpressionMR200InstructionsforUse Step 3 Action Turnthecontrolknobtoselectoneofthefollowingoptionsand thenpresstheknob:
AUTO ECG SPO2 Thesettingischanged. HR TONE SOURCE Setsthesourceusedfortheheartratetone(identicaltoandinteractivewithsameoptioninthe MONITOR>SOUNDADJUSTmenuandintheECGmenu). Thefollowingchoicesareavailable:
OFFremovestheheartsymbolfromthedisplayandnopulsetonewillbesounded.
(Default) QRSprovidesatonemodulatedbytheQRSdetectionfromtheECGvitalsign. SPO2providesatonemodulatedbytheSPO2vitalsign,wherethelowertheSPO2value, thelowerthepitch. Tosettheheartratetonesource EntertheSPO2menu.TurnthecontrolknobtoHRTONESOURCEandpresstheknob.Scrollto thedesiredsettingandpresstheknob.(Seepage38fordetailedinstructions.) ExpressionMR200InstructionsforUseMonitoringSPO2513 514MonitoringSPO2ExpressionMR200InstructionsforUse CHAPTER 6 Monitoring NiBP TheNiBP(noninvasivebloodpressure)parametermeasuresanddisplayssystolic,diastolicand meanarterialpressures.Alarmlimitsettingsareavailableforallthreepressures.Whenusing NiBPtomeasurebloodpressure,readingsarenotcontinuousbutareupdatedeachtimeablood pressuremeasurementistaken.Setashorterintervalwhenfrequentupdatingofthepatients bloodpressureisneeded.Visuallycheckingthepatient,confirmingNiBPmeasurementsagainst othervitalsignmeasurementsandattentiontothelimbwherethecuffisattachedmustbe standardroutinesduringNiBPuse. Adultandpediatricbloodpressuremeasurementsdeterminedwiththisdeviceareequivalentto thoseobtainedbyatrainedobserverusingthecuff/stethoscopeauscultatorymethod,withinthe limitsprescribedbytheAmericanNationalStandard,Manual,electronic,orautomated sphygmomanometers. Neonatalbloodpressuremeasurementsdeterminedwiththisdeviceareequivalenttothose obtainedbyanintraarterialbloodpressuremeasurementdevice,withinthelimitsprescribedby theAmericanNationalStandard,Manual,electronic,orautomatedsphygmomanometers. WARNINGS Use clinical judgment to decide whether to perform a repeated series of NiBP measurements because of the risk of purpura, ischemia and neuropathy in the limb with the NiBP cuff. Arrhythmias, erratic heartbeats and patient motion can result in inaccurate readings and/or prolonged measurements. If questionable readings are obtained, check the patients vital signs by alternate means before administering medication. The performance of the automated sphygmomanometer can be affected by extremes of temperature, humidity and altitude. An alarm will sound when the MR200 is too close to the MR magnet and shutdown of NiBP monitoring will occur. Always position the MR200 as indicated on page 2-6. CAUTIONS Substitution of components or accessories different from those supplied or recommended can result in measurement errors. NiBP accuracy has not been verified in the presence of some common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation. ExpressionMR200InstructionsforUseMonitoringNiBP61 Patient Preparation for NiBP Monitoring WARNING The NiBP cuff inflation rate may increase and the initial pressure may increase up to 180 mmHg when changing the patient type. ThePATIENTtypesettingdeterminestheinflationpressuresoftheNiBPcuffandthereading times. Insomecases,apatientmayexhibitalowpulseamplitudeduetoanyofthefollowing conditions.Thelistprovidesonlysomeexamplesofpotentialcausesoflowpulseamplitudesthat canmakeNiBPdifficulttomeasureinaconvenientandtimelymanner:
Sedation Diseaseorillness Physiologicalorneurologicalconditions Medication Obesity(oranyoccurrenceofmetabolismwithextremevariations) Stress Size CAUTION There may be occasions when a particular mode is not suitable for its apparent category of patients based on age alone. In these cases, a clinical decision shall be made to use another patient type, NiBP cuff size or measurement technique. The clinical decision shall be based on all of the factors listed in Determining the Patient Type (see page 3-10) to ensure the best possible and most timely NiBP measurement acquisition. NOTE ADULT and PEDIATRIC types dictate use of a larger NiBP cuff and interconnect hose size, while NEO uses smaller sizes; see the cuff and hose information on page 1-27. AwidevarietyofNiBPcuffsandinterconnecthosesareavailableforyourmonitoringneeds;see page127fordetails. 62MonitoringNiBPExpressionMR200InstructionsforUse Selecting the NiBP Cuff WARNING To ensure accurate reliable measurements, use only the recommended NiBP accessories. Use the appropriate NiBP cuff size for each patient, as recommended by the current American Heart Association guidelines for blood pressure monitoring, to ensure safety and accuracy. TheNiBPcuffshouldbeselectedand positionedasitwouldbeforanauscultatory bloodpressuredetermination.Thecurrent guidelinesoftheAmericanHeartAssociation mustbefollowed. Thebladderwidthofthecuffmustbe40 percentofthecircumferenceofthelimb.Itis alsoadvisabletokeeptheairvolumetoa minimumbyusingthesmallestcuffsize possibleforeachpatient.Thepointof maximumoscillationsiscoincidentwithmean arterialpressureregardlessofarterialelasticity solongastheratioofairvolumeinthecuffto thevolumeofthearteryundercompression doesnotgreatlyexceedten(10)toone(1). ForacorrectNiBPcufffit:
Adultandpediatricpatientstheindex lineonthesizechosenshouldfallwithin therangelinewhenplacedonthe patient. Neonatalpatientsthesizechosen shouldbewithinthestated circumferencerangeforthelimbofthe neonate. Allpatientsalignthecufftoensurethe arterymarkisplacedovertheartery. Index line Circumference range Range line Artery mark NiBP cuff WARNING Single use devices, as indicated on the device packaging, should be disposed of after use and must never be reused. Follow your hospitals guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. ExpressionMR200InstructionsforUseMonitoringNiBP63 Positioning the NiBPCuff WARNINGS Avoid compression, kinking or restriction of the NiBP cuff hose, as the effect of blood flow interference can result in patient injury caused by continuous cuff pressure. Do not use the NiBP cuff on a limb with an intravenous infusion or where an arterial catheter or arterio-venous (A-V) shunt is in place because of temporary interference to blood flow. This could result in injury to the patient. Do not place the NiBP cuff over a wound, as this can cause further injury. Do not place the NiBP cuff on the same or adjacent arm to a mastectomy, or where the lymph nodes were removed, or if a shunt is on that arm. This can lead to bruising, inaccurate readings, or negatively impact the drainage of fluids because of temporary interference to blood flow. WraptheNiBPcufffirmly(notsnuggly)aroundthearmorlegofthepatient,makingsurethat thecuffisattheapproximatelevelofthehearttoensureaccuracyoftheobtainedvalues. Connecting the NiBP Cuff WARNING Routinely inspect the NiBPcuff and hose assemblies for proper connection and orientation. Replace accessories that have cracks, holes, tears, or cuts that could cause leaks in the system. If such damaged NiBP cuff or hose assemblies are used, prolonged and/or inaccurate patient readings could result. ToconnecttheNiBPcuffandhose Step 1 Action Insertthe appropriate interconnecthose connectorontothe NiBPport.Pushthe hoseconnector forwardandthen turnitclockwise. NiBP port 2 AttachaNiBPcuffappropriateforthepatienttypeandsizetothe interconnecthose. 64MonitoringNiBPExpressionMR200InstructionsforUse Step Action 3 4 Positionthecuffonthepatient;seepage64. Ensurethatthecuffandinterconnecthosesarenotkinked. Choosing the Measurement Mode NiBPmeasurementscanbetakenusingamode(autoormanual)thatbestsuitstheneedsof yourpatient. Selecting Auto Mode Youcanautomaticallymeasureapatientsbloodpressureatpredefinedintervals,whichare measuredfromthestartofoneNiBPmeasurementtothestartofthenext. Toturnonautomaticoperation Step 1 Action PressthePatientkey andthenselecttheappropriate PATIENTtype;seepage310fordetails. TurnthecontrolknobtohighlighttheNiBPVSbox(seepage611) andthenpresstheknob. TheNiBPmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoINTERVALandthenpresstheknob. TheINTERVALmenuappears.Thecurrentsettingishighlighted. Turnthecontrolknobtoselectanyofthefollowingsettingsand thenpresstheknob:
1,2,2.5,3,5,10,15,20,30and45minutes,and1,2and4hours. Theselectionisentered. TurnthecontrolknobtoAUTOMODEandthenpresstheknob. TurnthecontrolknobtoONandthenpresstheknob. PresstheNiBPkey tobeginmeasurements. 2 3 4 5 6 7 ExpressionMR200InstructionsforUseMonitoringNiBP65 NOTE If gauss shutdown occurs during an AUTO MODE measurement, NiBP readings will stop. When at a safe distance, operation will resumea reading will be taken and then the intervals will begin again. Making Manual Measurements Youcanmanuallydefinethemeasurementintervalofapatientsbloodpressure. Tocontrolmanualoperation Step 1 Action PressthePatientkey andthenselecttheappropriate PATIENTtype;seepage310fordetails. PresstheNiBPkey tostartandstopamanualNiBP 2 measurement. Initial Inflation Pressures and Reading Durations WARNINGS Too frequent NiBP measurements can cause injury to the patient due to blood flow interference. Always monitor the NiBP cuff site (for example, by observation of the limb concerned) to ensure that operation of the automated sphygmometer does not result in prolonged impairment of the circulation of the blood of the patient. Pressurization of the NiBP cuff can can temporarily cause loss of function of simultaneously used monitoring ME equipment on the same limb. TheinitialinflationpressureistheamountthattheNiBPcuffwillinflateforthefirstNiBP measurement:
ADULTisusedformostadultpatients:Initialinflationpressure:16515mmHg PEDIATRICisusedforanypatientexhibitinglowpulseamplitudes(aconditionexhibitedby pediatricsizepatients):Initialinflationpressure:13015mmHg NEOisusedformostneonatalpatients:Initialinflationpressure:10015mmHg WhensubsequentNiBPmeasurementsaretakenonthesamepatient(andifnotinsuspend mode),themonitoradjuststheinflationvalueupordownbasedonthepreviousreadingresults. 66MonitoringNiBPExpressionMR200InstructionsforUse Stopping an NiBP Measurement PresstheNiBPkey tostopareadingcycle. NiBP VS Box DependingupontheselectedFORMAT(seepage614),theNiBPVSboxisdisplayedaccordingly. Systolic/Diastolic Format TheelementscontainedintheSYS/DIAformataredescribedbelow. 9 10 11 8 67 5 4 3 1 2 Definition 1 2 3 4 5 6 7 Is the NiBP diastolic pressure measurement (numeric) Is the low limit of the NiBP diastolic alarm setting; see page 6-12 Is the high limit of the NiBP diastolic alarm setting; see page 6-12 Is the low limit of the NiBP systolic alarm setting; see page 6-12 Is the high limit of the NiBP systolic alarm setting; see page 6-12 Is the unit of measure for the NiBP pressure readings, where mmHg is millimeters of mercury and kPa is kilopascals; see PRESSURE UNITS on page 11-16 Is the time since the last completed NiBP reading, displayed in the following format:
<hh>:<mm>:<ss>, where
<hh> = Two-digit hours field
<mm> = Two-digit minutes field
<ss> = Two-digit seconds field NOTE During a reading, this displays the cuff pressure. ExpressionMR200InstructionsforUseMonitoringNiBP67 Definition 8 9 Is the name of the vital sign Is the mode: where MANUAL is displayed when in Manual mode, and NEXT when in Auto mode. In Auto mode, indicates the time until the next NiBP measurement, displayed in the following format:
<hh>:<mm>:<ss>, where
<hh> = Two-digit hours field
<mm> = Two-digit minutes field
<ss> = Two-digit seconds field Is the NiBP mean pressure measurement (numeric) Is the NiBP systolic pressure measurement (numeric) 10 11 Mean Format TheelementscontainedintheMEANformataredescribedbelow. 6 7 8 9 5 4 1 2 3 Definition 1 2 3 4 5 Is the NiBP mean pressure measurement (numeric) Is the high limit of the NiBP mean alarm setting; see page 6-12 Is the low limit of the NiBP mean alarm setting; see page 6-12 Is the unit of measure for the NiBP pressure readings, where mmHg is millimeters of mercury and kPa is kilopascals; see PRESSURE UNITS on page 11-16 Is the time since the last completed NiBP reading, displayed in the following format:
<hh>:<mm>:<ss>, where
<hh> = Two-digit hours field
<mm> = Two-digit minutes field
<ss> = Two-digit seconds field NOTE During a reading, this displays the cuff pressure. 6 Is the name of the vital sign 68MonitoringNiBPExpressionMR200InstructionsforUse Definition 7 Is the mode: where MANUAL is displayed when in Manual mode, and NEXT when in Auto mode. In Auto mode, indicates the time until the next NiBP measurement, displayed in the following format:
<hh>:<mm>:<ss>, where
<hh> = Two-digit hours field
<mm> = Two-digit minutes field
<ss> = Two-digit seconds field Is the NiBP systolic pressure measurement (numeric) Is the NiBP diastolic pressure measurement (numeric) 8 9 Changing the NiBP Alarm Limits TochangetheNiBPalarmlimitsettings Step 1 Action TurnthecontrolknobtohighlighttheNiBPVSbox(seepage611) andthenpresstheknob. TheNiBPmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoALARMLIMITSandthenpresstheknob. TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;
seepage612fordetails. Turntheknobtotheloworhighsettingandthenpresstheknob. Themeasurementandsettingareselected. Turntheknobtochangethesettingvalueandthenpresstheknob tomakethechangeeffectiveandreturntothescrollingfunction. Thesettingischanged. Tochangeotheralarmsettings,repeatsteps3and4. 2 3 4 5 NOTE To make global changes to the parameter alarm limit settings based upon the patients current vital sign readings, see Setting Alarm Limits Globally on page 9-4. ExpressionMR200InstructionsforUseMonitoringNiBP69 Changing the Unit of Measure NOTE When using the IP5 and PRESSURE UNITS is changed, the displayed formatting of the value and placement of the decimal point is changed immediately. However, it can take up to 2 seconds for the numeric values to reflect the new unit of measure. Do not print or perform data captures during this period. Tochangetheunitofmeasure Step Action 1 2 3 4 5 6 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSERVICE(BIOMED)andpresstheknob. TheSERVICE(BIOMED)menuappears. TurnthecontrolknobtoSYSTEMCONFIGandpresstheknob. TheSYSTEMCONFIGsubmenuappears.Currentsettingsare displayed. TurnthecontrolknobtoPRESSUREUNITSandthenpresstheknob. ThePRESSUREUNITSmenuappears.Thecurrentsettingis highlighted. Turntheknobtothedesiredsettingandthenpresstheknob. mmHg kPa Thesettingisselected. 7 PresstheMainkey toclosethemenu. Alternative:TurntheknobtoRETURNandthenpresstheknob. 610MonitoringNiBPExpressionMR200InstructionsforUse NiBP Menu TheNiBPmenuallowsyoutocontrolnoninvasiveblood pressurefunctionsandsettings. TochangesettingsintheNiBPmenu Step 1 Action TurnthecontrolknobtohighlighttheNiBPVSboxandthenpress theknob. 2 3 4 5 TheNiBPmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoselectanyofthefollowingNiBPoptions andthenpresstheknob:
ALARMLIMITS INTERVAL AUTOMODE HRSOURCE HISTORY FORMAT Forinformationabouttheseoptions,seetheappropriatesections below. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeothersettings,repeatsteps2and3. PresstheMainkey toclosethemenu. Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. ExpressionMR200InstructionsforUseMonitoringNiBP611 ALARM LIMITS ControlsthealarmlimitsettingsforNiBP.(Seethetableonpage915foralisting.) 8 7 6 5 4 3 2 1 Definition 1 2 3 4 5 6 7 8 Are the settings of the high alarm limits Are the current measurements Are the settings of the low alarm limits Saves the settings and returns to the normal mode Identifies diastolic alarm limits Identifies mean alarm limits Identifies NiBP alarm limits Identifies systolic alarm limits TosetthealarmlimitsforNiBP SeeChangingtheNiBPAlarmLimitsonpage69. INTERVAL Setstheintervalforautomaticmeasurements. Thefollowingchoicesareavailable:
1Minute 2Minutes 2.5Minutes 3Minutes(Default) 5Minutes 10Minutes 612MonitoringNiBPExpressionMR200InstructionsforUse 15Minutes 20Minutes 30Minutes 45Minutes 1Hour 2Hours 4Hours TosettheintervalforNiBPreadings EntertheNiBPmenu.TurnthecontrolknobtoINTERVALandpresstheknob.Scrolltothe desiredtimeandpresstheknob. AUTO MODE SetsthemodeusedtotakeNiBPreadings. NOTE A manual reading will not restart this cycle time. Thefollowingchoicesareavailable:
ONtakesreadingsautomatically.Whenswitchedfromofftoon,thefirstreadingmustbe initiatedbypressingtheNiBPkey.Allsubsequentreadingswillbetakenautomaticallyat theselectedinterval. OFFtakesreadingsmanually(Manualmode),wherereadingsareinitiatedbypressingthe NiBPkey.(Default) TosetthemodeforNiBPreadings EntertheNiBPmenu.TurnthecontrolknobtoAUTOMODEandpresstheknob.Scrolltothe desiredmethodandpresstheknob. HISTORY Displaysthelast48NiBPreadingswiththetime,heartrate,SPO2,CO2andrespirationvaluesina tabularform(6perpage).Thisdataisretainedinnonvolatilememory,protectedagainstpower loss. ToviewpreviousNiBPreadings EntertheNiBPmenu.TurnthecontrolknobtoHISTORYandpresstheknob. ExpressionMR200InstructionsforUseMonitoringNiBP613 FORMAT Changestheformatofthedisplayedpressurenumerics. Thefollowingchoicesareavailable:
SYS/DIAdisplaystheNiBPreadingsinthesystolic/diastolicformat;seepage67.(Default) MEANdisplaystheNiBPreadingsinthemeanformat;seepage68. Tochangetheformat Step 1 Action TurnthecontrolknobtohighlighttheNiBPVSbox(seepage611) andthenpresstheknob. 2 3 TheNiBPmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoFORMATandthenpresstheknob. TheFORMATmenuappears.Thecurrentsettingishighlighted. Turnthecontrolknobtoselectfromthefollowingsettingsandthen presstheknob:
SYS/DIA MEAN Theselectionisentered. 614MonitoringNiBPExpressionMR200InstructionsforUse CHAPTER 7 Monitoring CO2 WhenequippedwiththeCO2option,theMR200samplesandanalyzesthepatientsairway respiratorygasusingsidestreammeasurementtoproduce:
Aninspired(FiCO2)valuederivedduringinspirationandanendtidal(EtCO2)value measuredduringexpiration. Arespirationrate(RESP):Thenumberofbreathsperminute;seechapter8fordetails. Awaveformoftheconcentrationofcarbondioxideintherespiratorygases. NOTE Inspired CO2 (FiCO2) is the lowest reading of the CO2 waveform in the previous 20 seconds. WARNINGS Do not use on patients that cannot tolerate the withdrawal of 50ml/min 10 ml/min from the airway or patients that cannot tolerate the added dead space to the airway. An alarm will sound when the MR200 is too close to the MR magnet and shutdown of CO2 monitoring will occur. Always position the MR200 as indicated on page 2-6. Patient Preparation for CO2 Monitoring Whenpreparingapatient,theaccessorypositiononthepatientwillimpacttheperformanceand operationoftheCO2parameter. Selecting the CO2 Accessory Inpatientsonabreathingcircuit,asampleoftherespiratorygasisdrawnfromthepatients breathingcircuitthroughanairwayadapterandagassamplingline.Inpatientswhoarenotona breathingcircuit,thegassampleisdrawnthroughanasalcannula.Thesespeciallydesigned cannulasandonairwayadaptersincorporateafilterandsamplecelltoprovidemaximum filtrationoffluidsandcontaminantstoprotectagainstsystemintake.WhenselectingCO2 accessories(seepage125),considerthefollowing:
Thetypeofpatient(adult,pediatric,orneonatal) Whetherthepatientisreceivingsupplementaloxygen Theconditionofthepatient ExpressionMR200InstructionsforUseMonitoringCO271 Allaccessoriesaresingleuse. Connecting the Sampling Line Toconnectthesamplingline Step 1 Action Insertthesamplinglineconnector intotheCO2portandthenpushthe connectorforwarduntilyoufeelor hearitclickintoplace. CO2 port Sampling line connector 2 3 IfCO2WARMINGUPisdisplayed,waitasthesystemthermally stabilizes.Whenthemessageiscleared,CO2isfullyoperational. AlwaysremovethepatientsamplinglinefromtheCO2portwhen notinuse.(Toremovethesamplingline,pressdownonthelocking tabandpulltheconnectorfromtheport.) NOTE To increase the life of the filter and pump, when CO2 will not be used to monitor a patient, it is recommended to turn off CO2 in the PARAMETER SELECTION menu; see page 3-7. WARNINGS Inspect CO2 port and accessories before use. If the sampling line, connector or port show signs of damage, replace the part immediately or discontinue use and contact technical support. Never use damaged equipment. Frequently inspect the patient sampling line and keep it clear of any moving mechanisms (for example, table wheels) which could cut, pinch, or dislodge the sampling line. Leaks, reduced or stopped flow, or internal venting of sampled gas into damaged tubing will cause inaccurate measurements. Do not position the sampling line in any manner that may cause entanglement or strangulation. Replace the sampling line if excessive secretions are observed, as inaccurate measurements could result if the flow is reduced or stopped. Leakages in the breathing system or sampling system may cause the displayed EtCO2 values to be too low. Always connect all components securely and check for leaks according to standard clinical procedures. Displacement of the sampling line cannula or airway adapter can cause lower than actual EtCO2 readings. 72MonitoringCO2ExpressionMR200InstructionsforUse If CO2 values for patients who are not on a breathing circuit appear extremely low, check whether the patient is breathing through the mouth or whether one nostril is blocked. NOTES For optimum fit and compatibility, use only specified parts. Always inspect patient sampling line after attachment to the MR200. Applying the Sampling Line to the Patient Selectthepatientsamplinglinethatisappropriateforthepatientsizeandapplication.Patient samplinglineswiththeairwayadapterareintendedforusewithbreathingcircuitsand anesthesiacircuitsthathaveanintegratedairwayadapter. WARNING Patient sampling lines are intended for single-patient use only. Do not clean or disinfect these items. Follow your hospitals guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. CAUTIONS The accuracy of the data is greatly influenced by the proper use and fitting of the patient sampling line to ensure proper sampling without the introduction of outside air. Remove the patient sampling line from the CO2 port when not in use. Toplacethesamplinglineonthepatient Step 1 2 Action Ensurethatthesamplinglineisclean,dryandundamaged.Replace thelineifnecessary. InsertthesamplinglineconnectorintotheCO2port(seepage72). Aclickwillbeheardwhenproperlyinserted. ExpressionMR200InstructionsforUseMonitoringCO273 Step 3 Action Placethesamplinglineontothepatient,asshownbelow. 4 5 Ifusingthesamplinglinewiththeairwayadapter,proceedtostep 5;otherwisegotostep7. Placetheairwayadapterattheproximalendoftheairwaycircuit betweentheelbowandthebreathingcircuitwye,asshownbelow. CAUTION Always insert the patient sampling line into the CO2 port before inserting the airway adapter into the breathing circuit. Failure to follow this may introduce a leak in the circuit, thereby reducing set minute volume. NOTE Do not place the airway adapter between the ET tube and the elbow as this may allow patient secretions to accumulate in the adapter. If pooling does occur, replace the airway adapter. To prevent moisture from draining into the airway adapter, always place the adapter tubing in a up position, as shown above. 6 PressthePatientkey andthenselecttheappropriate PATIENTtype;seepage310fordetails. 74MonitoringCO2ExpressionMR200InstructionsforUse Step 7 Action Checkthattheconnectionshavebeenmadecorrectlybyverifying thepatientsbreathingeffortswiththedisplayedwaveform. WARNING Before completion of patient setup, ensure that the patients breathing efforts coincide with the displayed CO2 waveform. 8 Ifthefollowingwarningisdisplayed:
PersistentCO2occlusiondetected. PleaseclearocclusionandpressOK toresumeusingCO2 Clearanypinchesorobstructionsinthesamplinglinebefore proceeding. ExpressionMR200InstructionsforUseMonitoringCO275 CO2 Waveform and VS Box TheelementscontainedintheCO2waveform(TraceD)andVSboxaredescribedbelow. 7 8 9 1 2 3 4 56 Definition 1 2 3 4 Is the high limit setting of the CO2 alarm; see page 7-9 Is the low limit setting of the CO2 alarm; see page 7-9 Is the inspired FiCO2 (inspired CO2) measurement (numeric) Is the unit of measure for the CO2 numeric data, where mmHg is millimeters of mercury and kPa is kilopascals; see page 7-11 Is the label for the FiCO2 measurement Is the name of the vital sign Is the detected CO2 waveform Is the label for the EtCO2 measurement Is the EtCO2 (expired CO2) measurement (numeric) 5 6 7 8 9 Changing the Waveform Speed TochangetheCO2waveformspeed Step Action 1 2 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. 76MonitoringCO2ExpressionMR200InstructionsforUse Step 3 Action TurntheknobtoRESPSPEEDandthenpresstheknob. 4 TheRESPSPEEDmenuappears.Thecurrentsettingishighlighted. Turnthecontrolknobtoselectanyofthefollowingsettings(see page314fordetails)andthenpresstheknob:
25mm/s 12.5mm/s 6.25mm/s 3.125mm/s 1.5625mm/s 0.33333mm/s Theselectionisentered. Changing the CO2 Alarm Limits TochangetheEndtidalCO2alarmlimitsettings Step 1 Action TurnthecontrolknobtohighlighttheCO2VSbox(seepage78) andthenpresstheknob. TheCO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoALARMLIMITSandthenpresstheknob. TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;
seepage79fordetails. Turntheknobtotheloworhighsettingandthenpresstheknob. Thesettingisselected. Turntheknobtochangethesettingvalueandthenpresstheknob tomakethechangeeffectiveandreturntothescrollingfunction. Thesettingischanged. Tochangetheremainingsetting,repeatsteps3and4. 2 3 4 5 NOTES To make global changes to the parameter alarm limit settings based upon the patients current vital sign readings, see Setting Alarm Limits Globally on page 9-4. The high alarm limit for inspired CO2 is fixed. ExpressionMR200InstructionsforUseMonitoringCO277 Changing the Unit of Measure Tochangetheunitofmeasure Step 1 Action TurnthecontrolknobtohighlighttheCO2VSbox(seebelow)and thenpresstheknob. TheCO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoUNITandthenpresstheknob. TheUNITmenuappears.Thecurrentsettingishighlighted. TurntheknobtoselectoneofthefollowingCO2settings:
2 3 mmHg kPa Thesettingisselected. CO2 Menu TheCO2menuallowsyoutocontrolCO2andCO2derived respirationfunctionsandsettings. TochangesettingsintheCO2menu Step 1 Action TurnthecontrolknobtohighlighttheCO2VSboxandthenpress theknob. TheCO2menuappears.Currentsettingsaredisplayed. 78MonitoringCO2ExpressionMR200InstructionsforUse Step 2 Action TurnthecontrolknobtoselectanyofthefollowingCO2options andthenpresstheknob:
ALARMLIMITS SIZE GRIDS ZEROCAL UNIT Forinformationabouttheseoptions,seetheappropriatesections below. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeothersettings,repeatsteps2and3. PresstheMainkey toclosethemenu. 3 4 5 Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. ALARM LIMITS ControlsthealarmlimitsettingsforCO2.(WhenSOURCEissettoBELintheRESPmenu,theCO2 respirationalarmlimitsettingswillalsobedisplayed;seepage85.) 5 4 3 2 1 Definition 1 2 3 4 5 Is the setting of the high alarm limit Is the current measurement Is the setting of the low alarm limit Saves the settings and returns to the normal mode Identifies expired CO2 alarm limits ExpressionMR200InstructionsforUseMonitoringCO279 TosetthealarmlimitsforCO2 SeeChangingtheCO2AlarmLimitsonpage77. SIZE SetstheCO2waveformsize. Thefollowingchoicesareavailable:
40mmHg(Default) 60mmHg 80mmHg ToadjustthegridsizefortheCO2waveform EntertheCO2menu.TurnthecontrolknobtoSIZEandpresstheknob.Scrolltothedesiredsize andpresstheknob. GRIDS ControlstheCO2griddisplay. Size Grid Thefollowingchoicesareavailable:
ON OFF(Default) TocontrolCO2griddisplay EntertheCO2menu.TurnthecontrolknobtoGRIDSandpresstheknob.Scrolltothedesired settingandpresstheknob. NOTE Grids will not be displayed during a CO2 ACCURACY CHECK; see page 11-14. 710MonitoringCO2ExpressionMR200InstructionsforUse ZERO CAL Initiatesazerocalibration(anautomaticfunctionduringnormaluse)oftheCO2systemtoallow forthedifferentcharacteristicsofeachaccessorytype.Themaximumtimerequiredforis approximately40seconds. Undercertainconditions,ZEROCALwillnotbeallowed:
Iflessthan20secondshavepassedsincedetectionofthelastbreath;
IftheCO2temperatureisunstable;or WhenthesamplinglineisdisconnectedfromtheCO2port. NOTE ZERO CAL is not required when switching sampling lines. Toperformazerocalibration Step Action 1 2 3 EnsurethatCO2WARMINGUPisnotdisplayed. TurnthecontrolknobtohighlighttheCO2VSboxandthenpress theknob. TheCO2menuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoselectZEROCALandthenpresstheknob. PERFORMINGCO2ZEROwillbedisplayedduringcalibration.And then,whencomplete,themessagewillberemoved. UNIT SelectstheunitofmeasureusedforpresentationoftheCO2numericdata. Thefollowingchoicesareavailable:
mmHg(Default) kPa ToselecttheunitofmeasureforCO2 EntertheCO2menu.TurnthecontrolknobtoUNITandpresstheknob.Scrolltothedesired settingandpresstheknob. ExpressionMR200InstructionsforUseMonitoringCO2711 712MonitoringCO2ExpressionMR200InstructionsforUse CHAPTER 8 Monitoring RESP IfequippedwiththeCO2option,thepatientsrespirationratewillbecalculatedbymeasuringthe timeintervalbetweendetectedbreaths.WhenmonitoringrespirationderivedfromCO2,alarm functionsareprovidedformonitoring. Respirationratecanalsobemeasuredusingthebellowsdevice;however,alarmfunctionsforthis methodarenotprovided. Patient Preparation for RESP Monitoring Whenpreparingapatient,themonitoringmethodusedwillimpacttheperformanceand operationoftheRESPparameter. Monitoring Respiration using CO2 RespirationusingtheCO2parameteriscalculatedbymeasuringthetimeintervalbetween detectedbreaths;refertochapter7fordetails. Monitoring Respiration using the Bellows ThewSPO2moduleandbellowsareintendedforpatientusesasanalternatetoCO2derived respirationwhenrespirationratemeasurementsarerequired.ThewSPO2moduleandbellows maybeusedintheMRsystembore,althoughthemodulemustnotbeplacedwithintheMRI fieldofview(FOV). CAUTION If dropped, the wSPO2 module must be verified for correct operation before use. NOTE Refer to your facility's biohazard procedure for disposal of the bellows when it becomes unusable. Usually the bellows is disposed of as medical waste per facility procedures. ExpressionMR200InstructionsforUseMonitoringRESP81 Respirationismonitoredbydetectingabdominalorchest wallmotionusingapneumaticbellowsdevice.Notethat therearenouseradjustableoptionsoralarmsfor bellowsderivedrespirationasitisnotintendedforvital signmonitoring. NOTE If bellows respiration is turned on while the CO2 is on, bellows respiration data will appear in the RESP VS box and CO2 respiration data will appear in the CO2 VS box. Bellows Preparation Respirationmeasurementsthataredeterminedusingthebellowsmethodmakechestwall expansionveryimportantforaccuratemonitoringofapatientsbreathing.Iftherespiratory signalappearstoweakenbetweenscans,instructthepatienttobreathemoredeeplyduringthe scantocreatemoremovementatthesensorsite. Topositiontherespiratorysensor Step 1 2 3 Action Placethesensoronthepatientsupperabdomenorlowerchest
(whicheverexpandsmostduringinspiration). Afterthepatienthasexhaled,placethevelcrostraparoundthe patientstrunkandsecurethesensorsnuggly. Connecttheflexiblehosetothepneumaticrespirationportonthe wSPO2module. Pneumatic respiration port Status indicator 4 Checkthestatusindicatorofthemodule;seepage28:
Solidgreen=Batterypowergood/Goodcommunication Flashinggreen=Batterypowergood/Nocommunication Solidred=Lowbatterypower/Goodcommunication Flashingred=Lowbatterypower/Nocommunication 82MonitoringRESPExpressionMR200InstructionsforUse Step 5 Action PressthePatientkey andthenselecttheappropriate 6 7 PATIENTtype(seepage310fordetails). ChecktherespiratorysignalbeforethepatientisplacedintheMR system. PositionthepatientintheMRsystem.Ensurethattheflexiblehose doesnotgetcaught(forexample,betweenthetabletopandthe patientsupport). CAUTIONS Avoid excessive bending of the flexible hose, as this will impair detection of the patients respiration. Always apply the respiration sensor to the patient prior to connecting to the pneumatic respiration port on the wSPO2 module. Connecting the pneumatic respiration sensor hose to the port prior to applying the sensor to the patient can result in damage to the wSPO2 module. Respiration VS Box TheelementscontainedintheRESPVSboxaredescribedbelow. NOTE CO2-derived respiration is shown in the example below. When bellow-derived respiration is selected, the related elements and VS box are displayed in white. 5 6 4 1 2 3 Definition 1 2 Is the high limit setting of the respiration alarm (not present with bellows respiration);
see page 8-5 Is the low limit setting of the respiration alarm (not present with bellows respiration);
see page 8-5 ExpressionMR200InstructionsforUseMonitoringRESP83 Definition 3 4 Is the unit type for the respiration numeric data, where RPM is respirations per minute Is the source used for the respiration monitoring, where CO2 is CO2-derived, and BEL is bellows-derived; see page 8-6 Is the name of the vital sign/parameter Is the respiration rate measurement (numeric) 5 6 Changing RESP Alarm Limits TochangetheRESPalarmlimitsettings Step 1 Action TurnthecontrolknobtohighlighttheRESPVSbox(seepage85) andthenpresstheknob. TheRESPmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoALARMLIMITSandthenpresstheknob. TheALARMLIMITSmenuappears.Currentsettingsaredisplayed;
seepage85fordetails. Turntheknobtotheloworhighsettingandthenpresstheknob. Thesettingisselected. Turntheknobtochangethesettingvalueandthenpresstheknob tomakethechangeeffectiveandreturntothescrollingfunction. Thesettingischanged. Tochangetheremainingsetting,repeatsteps3and4. 2 3 4 5 NOTE To make global changes to the parameter alarm limit settings based upon the patients current vital sign readings, see Setting Alarm Limits Globally on page 9-4. 84MonitoringRESPExpressionMR200InstructionsforUse RESP Menu TheRESPmenuallowsyoutocontrolrespirationfunctionsandsettings. TochangesettingsintheRESPmenu Step 1 Action TurnthecontrolknobtohighlighttheRESPVSboxandthenpress theknob. TheRESPmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoselectanyofthefollowingRESPoptions andthenpresstheknob:
ALARMLIMITS SOURCE Forinformationabouttheseoptions,seetheappropriatesections below. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeothersettings,repeatsteps2and3. PresstheMainkey toclosethemenu. 2 3 4 5 Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. ALARMLIMITS ControlsthealarmlimitsettingsforCO2derivedrespiration.(Seethetableonpage915fora listing.) ExpressionMR200InstructionsforUseMonitoringRESP85 5 4 3 2 1 Definition 1 2 3 4 5 Is the setting of the high alarm limit Is the current measurement Is the setting of the low alarm limit Saves the settings and returns to the normal mode Identifies CO2-derived respiration rate alarm limits Tosetthealarmlimitsforrespiration SeeChangingtheRESPAlarmLimitsonpage84. SOURCE Selectsthesourceusedtoacquirerespirationmeasurements. Thefollowingchoicesareavailable:
CO2calculatestheratebymeasuringthetimeintervalbetweendetectedbreaths.(Default, whenCO2equipped) BELcalculatestherateusingapneumaticbellowsthatmeasureschestorabdominal movement. Toselectthesourceforrespiration EntertheRESPmenu.TurnthecontrolknobtoSOURCEandpresstheknob.Scrolltothedesired sourceandpresstheknob. 86MonitoringRESPExpressionMR200InstructionsforUse CHAPTER 9 Alarms TheMR200alertstheusertophysiological,technicalandstatusalarmswhichmayrequire attentionorintervention. Alarm Indications Activealarmsconsistofbothvisualandaudiblecomponents,wherevisualindicationsare providedbytheLCDandaudibleindicationsareprovidedbythespeaker.Thealarmtoneisuser adjustablewithatypicalsoundpressurelevelof4883decibels,andwillsoundafteradelayof nomorethan4secondsfollowingavisualalarmindication,providedthatthealarmcondition stillexistsafterthisdelay. Alarm Safety Information WARNINGS The monitor detects and responds almost immediately to most out-of-limits conditions, except when averaging of the physiological signal is required to reduce unwanted noise signals (for example, respiration rates and measurements derived from SPO2 signals.) Set the alarm volume based upon the ambient noise levels in the MR environment. Some areas in the MR environment, such as the MR system room, may have ambient noise levels louder than the maximum volume of the MR200. Therefore, displayed data should be continuously monitored. Otherwise, if sound was inaudible, treatment of the patient could be delayed. For visual alarms, adjust the position of the cart so that you maintain a clear view of the display. Status and Technical Alarms Conditionsorevents(suchaslowbatteriesorhardwareerrors)canresultinalarms,which generatemessagesthatwillbedisplayedinaparametersVSboxand/orinthesystemmessage areaorthenotificationareaoftheLCD(seepage213). ExpressionMR200InstructionsforUseAlarms91 NOTE If a systemic failure of the processing hardware, software or communications renders an intended task incomplete and unperformed, a watchdog circuit will automatically shutdown power to the WPU. This will result in the removal of all patient data and displayed information, and a continuous alarm will sound until power to the MR200 is turned off. If this problem persists, contact technical support. Physiological Alarms Duringmonitoring,ifapatientsvitalsignmeasurementviolatesanactivealarmlimitsetting,a physiologicalalarmwillbedeclared.Themonitorrespondsbysoundinganalarm(ifenabled)and byflashingthenumericandwaveform(ifprovided)oftheviolatedparameterinredontheLCD. Forexample,ifapatientsheartrateclimbsto71BPM(whichisabovethesettingof60forthe upperalarmlimitoftheECGvitalsign)analarmconditionisdeclared. 1 2 3 Definition 1 2 3 Violated numeric Violated alarm limit Violated waveform Enabling Print on Alarm IftheMR200isconnectedtoanIP5printer,youcanautomaticallygenerateaprintoutwhena physiologicalalarmoccurs.SeetheIP5IFUforsettingdetails. 92AlarmsExpressionMR200InstructionsforUse Controlling Alarm Indications WARNINGS Always respond promptly to any alarm condition; otherwise, treatment of the patient could be delayed. You should ensure that the current alarm preset is appropriate prior to use on each patient. Failure to do so may cause a lapse in patient monitoring. Setting the alarm limits to extreme values can render alarm monitoring useless. Also, potential hazard can exist if different alarm monitoring settings are used for the same or similar equipment in any single patient care unit. Ignoring these restrictions may cause a lapse in patient monitoring. TheMR200canbesettoprovidevisualalarmsignalsonly,orbothvisualandaudiblealarm signals.AllsettingsintheALARMSmenu(exceptALARMSOUND)canbestoredandrecalled. NOTE If the MR200 is networked to an IP5, alarm indications occur at both the cart and the IP5; and control of alarms, including sound level, is localized to the unit (cart or IP5) indicating the alarm condition. Latched and Unlatched Alarms Whenanunlatchedalarmoccurs,thealarmstopswhentheconditionthattriggeredthealarm ends.Forexample,ifabatterybecomeslow,thealarmendswhenthebatteryisreplaced.The majorityofMR200alarmsareunlatched. Ontheotherhand,alatchedalarmcontinuesevenaftertheconditionthatcausedthealarmwas resolved.LOWPERFisanexampleofalatchedalarm.IfLOWPERFoccursbutthenreturnsto withinanormalrange,thealarmwillcontinuetodisplaytonotifytheclinicianoftheSPO2event.
(Toclearalatchedalarm,seepage97.) Showing or Hiding Current Alarm Limits CurrenthighandlowalarmlimitsaredisplayedintheVSboxofeachmonitoredparameterby default(exceptbellowsderivedrespiration). ExpressionMR200InstructionsforUseAlarms93 Tochangethealarmlimitdisplay Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. WithALARMSETUPhighlighted,pressthecontrolknob. TheALARMSmenuappears.Currentsettingsaredisplayed. TurntheknobtoLIMITSDISPLAYandthenpresstheknob. Scrolltothedesiredsettingandpresstheknob. Thesettingisselected. Setting Alarm Limits WARNING Alarm limits can be set to a wide range of values, including off. It is the responsibility of the operator of the MR200 to ensure that alarm limit values appropriate for each patient are established and set. Failure to do so may cause a lapse in patient monitoring. TheMR200providesversatilemethodstocontrolthesettingsforthepatientparameteralarms. Eachpatientparameter(withtheexceptionofbellowsrespiration)hasalowandhighalarmlimit setting(seethetableonpage914),whichcanbechangedmanuallyorautomatically,unlessthe parameterisoff. Setting Alarm Limits Globally Globalchangescanbemadetoallparameteralarmlimitsettingsbaseduponthepatients currentvitalsignreadingusingCALCULATEALL;seepage910fordetails.Duringthisprocess,ifa patientsmonitoredvalueissohighorlowthatitwillexceedthealarmlimitrangeforthe parameter,therespectivealarmlimitwillbesettothehighestorlowestpossiblevalue,butnot tooff.Forexample,ifafterperformingCALCULATEALL,apatientsSPO2upperalarmlimitwas automaticallysetto99(thehighestallowablevalue),thenanalarmwillbegeneratedifthe patientsreadingreaches100.Ifyouwanttoturnofftheupperlimit,thenitmustbedone manually;seeSettingAlarmLimitsIndividuallyonpage95. AlsonotethatwhenusingCALCULATEALLitwillalmostalwaysresultinalowerSpO2limitthan thedefaultsetting.ForapatientthathasanSpO2readingof99%thenewupperlimitwillbe99, butthenewlowerlimitwillbe79(insteadof85)ataCALCULATEALLoffsetof20%(factory default). 94AlarmsExpressionMR200InstructionsforUse Toadjustthealarmlimitsettingsforallmonitoredparameters Step 1 Action WiththepatientconnectedtotheMR200andwith thedesiredparametersturnedon,presstheSETUPkey
. 2 3 4 5 6 7 TheSETUPmenuappears. WithALARMSETUPhighlighted,pressthecontrolknob. TheALARMSmenuappears.Currentsettingsaredisplayed. TurntheknobtoUPPERWINDOWandthenpresstheknob. Thecurrentsettingishighlighted. Scrolltothedesiredpercentageandpresstheknob.Thefollowing choicesareavailable:
5%
10%
15%
20%
30%
Thesettingisselected. TurntheknobtoLOWERWINDOWandthenpresstheknob. Thecurrentsettingishighlighted. Scrolltothedesiredpercentageandpresstheknob.Thefollowing choicesareavailable:
5%
10%
15%
20%
30%
Thesettingisselected. ScrolltoCALCULATEALLthenpresstheknob. Allactivealarmlimitsettingsarechanged. Setting Alarm Limits Individually IndividualparameteralarmlimitsettingscanbecontrolledintheALARMSmenuorinthe parametersmenu(seetheappropriatemonitoringchapterfordetails). ExpressionMR200InstructionsforUseAlarms95 Toadjustthealarmlimitsettingsforasingleparameter(usingtheALARMSmenu) Step Action 1 2 3 4 5 6 PresstheSETUPkey
. TheSETUPmenuappears. WithALARMSETUPhighlighted,pressthecontrolknob. TheALARMSmenuappears.Currentsettingsaredisplayed. WithSETINDIVIDUALhighlighted,presstheknob. Thecursorhighlightsalowalarmlimitsettinginthemenu. Turnthecontrolknobtoselectthealarmlimittobechangedand thenpresstheknob. Thesettingisselectedandthehighlightingchangescolor. Turntheknobtochangethesettingvalueandthenpresstheknob tomakethechangeeffectiveandreturntothescrollingfunction. Thesettingischanged. Tochangeanyremainingsettings,repeatsteps4and5. Restoring Default Alarm Limit Settings Thesystemautomaticallyrestoresdefaultvalueswhenyouchangethepatienttype.(Seepage9 15forthedefaultsettings.) Torestorethealarmlimitstothedefaultsettings Step 1 Action WithamonitoredpatientconnectedtotheMR200,pressthe SETUPkey
. TheSETUPmenuappears. WithALARMSETUPhighlighted,pressthecontrolknob. TheALARMSmenuappears.Currentsettingsaredisplayed. TurntheknobtoDEFAULTLIMITSandpresstheknob. 2 3 Thealarmsettingsarereturnedtothedefaultvalues. 96AlarmsExpressionMR200InstructionsforUse Controlling the Alarm Sound Thealarmvolumecanbeadjusted.Inaddition,thealarmsoundcanbetemporarilydisabledby pressingtheSilencekey,oritcanbepermanentlydisabledintheALARMSmenu(althoughthe numericandwaveformwillcontinuetoflashwhiletheparameterviolatesitsalarmlimit). Oncesilenced,analarmwillnotsoundagainforanyreasonaslongasthatconditioncontinues. Onlyadifferentparameterviolationwillcausethealarmsoundtoreactivate.(Forexample,ifa patientsheartratedropsbelowthesetlimitandthatalarmissilenced,thealarmwillnotsound forthatconditionagainunlesstheheartratereturnstowithinlimitsandthendropsbelowthe limitagain.) AnactivesilencedalarmmaynotbeaccompaniedbyanALARMSILENCEDmessageor symboliftheAlarmHoldsequencehasbeenactivated,orifasubsequentalarmhasoccurredand selfcorrected. Adjusting the Alarm Volume Toincreaseordecreasethealarmvolume Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. TurntheknobtoMONITORSETUPandpressthecontrolknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurntheknobtoSOUNDADJUSTandpresstheknob. TheSOUNDADJUSTmenuappears.Thecurrentsettingsare displayed. TurntheknobtoALARMVOLUMEandpresstheknob. 110(4883decibels,typical) Thecurrentsettingishighlighted.Forverificationduring adjustment,anacknowledgementissoundedattheselectedlevel. Silencing the Alarm PressingtheSilencekey TYPEsetting(seepage913):
duringanalarmwillsilenceallactivealarms,dependinguponthe IfUNLATCHED,theSilencekeywillmutethealarmsoundand,whiletheviolation continues,thedisplayednumericandwaveformoftheparameterwillflashinred.Any newalarmconditionwillcausethealarmtoreactivate.Oncetheparameterreturnsto ExpressionMR200InstructionsforUseAlarms97 withinitsalarmlimit,thenumericandwaveformwillstopflashingandreturntotheir designatedcolor. IfLATCHED,whiletheparametercontinuestoviolateitslimit,theSilencekeywillmutethe alarmsound.Thenumericandwaveformwillcontinuetoflashinredaftertheparameter returnstowithinitsalarmlimits,thenuponpressingtheSilencekeyasecondtimethe numericflashingstopsandtheaudiblealarmisplacedintoAlarmHoldmode. Tosilenceaudiblealarms PresstheSilencekey. Alarm Hold Mode AlarmHoldcanbeusefultotemporarilysilencealarmswhenchangingECGleadsorforotheruser activitiesthatmightcauseafalsealarm. AlarmHoldisindicatedwhen messageareawithacountdowntimerstartingat120seconds.Theholdperiodisnotuser adjustable.Duringtheholdperiod,theaudiblealarmwillbesuspendedforanynewalarm conditionsthatoccur. isdisplayedandSOUNDONHOLDappearsinthesystem ToactivateAlarmHold PresstheSilencekey
:
Ifthealarmisnotsounding,pressingthekeyenablesholdmode. Ifthealarmissounding,pressingthekeytwiceenablesholdmode. Aftertheholdperiodexpires,thesoundforthephysiologicalalarmsarerestored.Alarm conditionspreviouslysilencedbypressingtheSilencekeywillnottriggeranaudiblealarmwhen theholdperiodtimesout. TodeactivateAlarmHold Waituntilthecountdowncompletes;or, PresstheSilencekey. ALARMS Menu TheALARMSETUPoption(intheSETUPmenu)openstheALARMSmenu,whichcontains optionsforsetupandcontrolofthevitalsignalarms. 98AlarmsExpressionMR200InstructionsforUse ALARMS menu Setup key Control knob TochangesettingsintheALARMSmenu Step Action 1 2 3 PresstheSETUPkey
. TheSETUPmenuappears. WithALARMSETUPhighlighted,pressthecontrolknob. TheALARMSmenuappears.Currentsettingsaredisplayed. Turnthecontrolknobtoselectanyofthefollowingsystemwideor individualalarmoptionsandthenpresstheknob:
SETINDIVIDUAL CALCULATEALL UPPERWINDOW LOWERWINDOW ALARMSOUND DEFAULTLIMITS TYPE LIMITSDISPLAY Forinformationabouttheseoptions,seetheappropriatesections below. 4 Turntheknobtothedesiredsettingandthenpresstheknob. ExpressionMR200InstructionsforUseAlarms99 Step Action 5 6 Tochangeotheroptions,repeatsteps3and4. PresstheMainkey toclosethemenu. Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. SET INDIVIDUAL Controlsthealarmlimitsettingsforindividualparameters. 1 2 3 4 5 Definition 1 2 3 4 5 Identifies the parameter Are the current settings of the low alarm limits Are the current readings of the patient Are the current settings of the high alarm limits Exits the menu Toindividuallyadjustthealarmlimitsettings Seepage95. CALCULATE ALL CalculatesnewalarmlimitsettingsforallactiveparametersaccordingtothesettingsinUPPER WINDOWandLOWERWINDOWoptions(seebelow).Correspondinglowandhighcalculations willbeperformedforeachactiveparameter. 910AlarmsExpressionMR200InstructionsforUse Togloballyadjustthelowandhighalarmlimitsettings SeeSettingAlarmLimitsGloballyonpage94. NOTE If a patients monitored value is so high or low that it exceeds the alarm limit range for the parameter, the respective alarm limit will be set to the highest or lowest possible value, but not to off, as indicated in the table on page 9-14. UPPER WINDOW SetsapercentvalueusedtocalculatethehighalarmlimitswhenCALCULATEALLisselected.The currentparametervalueisbracketedwiththepercentagessetinthismenuandtheLOWER WINDOWsetting. Thefollowingchoicesareavailable:
5%
10%
15%
20%(Default) 30%
Tosettheuppercalculationvalue EntertheALARMSmenu.TurnthecontrolknobtoUPPERWINDOWandpresstheknob.Scrollto thedesiredpercentageandpresstheknob. LOWER WINDOW SetsapercentvalueusedtocalculatethelowalarmlimitswhenCALCULATEALLisselected.The currentparametervalueisbracketedwiththepercentagessetinthismenuandtheUPPER WINDOWsetting. Thefollowingchoicesareavailable:
5%
10%
15%
20%(Default) 30%
Tosetthelowercalculationvalue ExpressionMR200InstructionsforUseAlarms911 EntertheALARMSmenu.TurnthecontrolknobtoLOWERWINDOWandpresstheknob.Scroll tothedesiredpercentageandpresstheknob. ALARM SOUND WARNING The alarm sound can be turned off. Always ensure that the alarm sound setting is appropriate for each patient. The alarm sound volume is adjustable for suitability to various clinical environments. When you use the MR200, always ensure that the alarm sound can be heard above the ambient noise level. Failure to do so may cause a lapse in patient monitoring. Controlstheaudioalertforthealarms(identicaltoandinteractivewithMONITOR>SOUND ADJUST>ALARMS;seepage38). Thefollowingchoicesareavailable:
ONturnsonthealarmsound,where
(Default) indicatesthatthesoundhasbeenenabled. OFFturnsoffthealarmsound,where indicatesthatthesoundhasbeendisabled.
(Onlythealarmsoundwillbedisabled;thevisualalertfromthesourceoftheviolationstill flashesinred.) Tosetthealarmsound Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. WithALARMSETUPhighlighted,pressthecontrolknob. TheALARMSmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoALARMSOUNDandthenpresstheknob:
Turntheknobtothedesiredsettingandthenpresstheknob. DEFAULT LIMITS Automaticallysetsthelowandhighalarmlimitsforallparameterstothealarmlimitdefaults
(seethetableonpage915). Tosetthealarmlimitsettingstothedefaultlimits SeeRestoringDefaultAlarmLimitSettingsonpage96. 912AlarmsExpressionMR200InstructionsforUse TYPE DeterminestheresponseofanalarmwhentheSilencekeyispressed. Thefollowingchoicesareavailable:
UNLATCHEDalarmsceaseaudioandvisualalertsiftheviolatedparameterreturnswithin itslimitsoriftheSilencekeyispressed.(Default) LATCHEDalarmsceaseaudioandvisualalertsonlywhentheSilencekeyispressed. Tosetthetypeofthealarm EntertheALARMSmenu.TurnthecontrolknobtoTYPEandpresstheknob.Scrolltothedesired settingandpresstheknob. LIMITS DISPLAY DeterminesifthealarmlimitsettingsareshownintheVSboxes. Thefollowingchoicesareavailable:
ONdisplaysthealarmlimitsettings.(Default) OFFhidesthealarmlimitsettings. Tocontrolthepresenceofthealarmlimitsettings EntertheALARMSmenu.TurnthecontrolknobtoLIMITSDISPLAYandpresstheknob.Scrollto thedesiredsettingandpresstheknob. Testing Alarms Toverifythatthealarmsystemisworking Step Action 1 2 Withthemonitorturnedonandnotinsuspendmode,makesureall alarmsareenabled(ALARMSOUNDisnotoff,silenced,oronhold). MakesurethelowerSPO2alarmlimitisnotsettoOFF. ExpressionMR200InstructionsforUseAlarms913 Step 3 Action VerifythewSPO2modulestatusbycheckingthestatusindicator:
Solidgreen=BatterypowerOK/Goodcommunication Flashinggreen=BatterypowerOK/Nocommunication Solidred=Lowbatterypower/Goodcommunication Flashingred=Lowbatterypower/Nocommunication PlacetheSPO2attachmentonyourfingerandwaitforavalueto appearintheSPO2VSbox. Removetheclipfromyourfinger. EnsurethattheNONPULSATorPROBEOFFmessageappearsin theSPO2VSbox,thewaveformflatlinesandturnsred,the numericflashesinred,andthealarmtonesounds. 4 5 6 NOTE If a problem with the alarm sound or messaging system is suspected, discontinue use of the MR200 and refer it to authorized service personnel for evaluation. Adjustable Alarm Limit Ranges Withtheexceptionofbellowsrespiration,eachparameteralarmhasadjustablelimitsasindicatedin tablebelow.TheMR200preventscrossoveroflowandhighalarmlimitsettings;and,ifaparameter hasbeenturnedoff,itsalarmlimitswillbeoff. Vital Sign or Parameter Heart Rate CO2 (End-tidal)**
CO2 Respiration NiBP Systolic, Adult NiBP Systolic, Pediatric NiBP Systolic, Neonate Unit BPM mmHg kPa RPM mmHg kPa mmHg kPa mmHg kPa Adjustable Alarm Limit Ranges Low Alarm Limit *
High Alarm Limit *
Minimum Maximum Minimum Maximum Off, 30 Off, 5 Off, 0.7 Off, 4 Off, 46 Off, 6.1 Off, 46 Off, 6.1 Off, 46 Off, 6.1 249 60 8.0 40 254 33.9 254 33.9 124 16.5 60 5 0.7 20 46 6.1 46 6.1 46 6.1 249, Off 80, Off 10.7, Off 99, Off 254, Off 33.9, Off 254, Off 33.9, Off 124, Off 16.5, Off 914AlarmsExpressionMR200InstructionsforUse Vital Sign or Parameter NiBP Mean, Adult NiBP Mean, Pediatric NiBP Mean, Neonate NiBP Diastolic, Adult NiBP Diastolic, Pediatric NiBP Diastolic, Neonate SPO2 Unit mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa Percent Adjustable Alarm Limit Ranges Low Alarm Limit *
High Alarm Limit *
Minimum Maximum Minimum Maximum Off, 26 Off, 3.5 Off, 26 Off, 3.5 Off, 26 Off, 3.5 Off, 16 Off, 2.1 Off, 16 Off, 2.1 Off, 16 Off, 2.1 Off, 50 239 31.9 239 31.9 94 12.5 224 29.9 224 29.9 84 11.2 99 26 3.5 26 3.5 26 3.5 16 2.1 16 2.1 16 2.1 70 239, Off 31.9, Off 239, Off 31.9, Off 94, Off 12.5, Off 224, Off 29.9, Off 224, Off 29.9, Off 84, Off 11.2, Off 99, Off
*Allowoneleastsignificantdigittoaccommodatetheroundofferrorforcalculatedvalues.
**HighalarmlimitforinspiredCO2isfixed. Alarm Limit Defaults Intheeventofpowerloss,anyalarmlimitsettingsthatwerechangedwillbelost.Allsettingsthat mayhavebeenmodifiedtosuitaparticularpatientshouldbeconfirmedbeforemonitoring. Atpowerup,theMR200willautomaticallysetallalarmlimitsasdeterminedbythesettinginthe DEFAULTSETUPSmenu;seepage313. Vital Sign or Parameter Heart Rate CO2 (End-tidal) CO2 Respiration NiBP Systolic NiBP Mean Factory Default Alarm Limits*
Neonate Pediatric Unit BPM mmHg kPa RPM mmHg kPa mmHg kPa Low Limit 90 30 4.0 30 70 9.3 40 5.3 High Limit 210 45 6.0 70 100 13.3 90 12.0 Low Limit 75 15 2.0 4 70 9.3 50 6.7 High Limit 160 60 8.0 40 120 16.0 90 12.0 Adult Low Limit 45 15 2.0 4 65 8.7 55 7.3 High Limit 160 60 8.0 40 190 25.3 135 18.0 ExpressionMR200InstructionsforUseAlarms915 Vital Sign or Parameter NiBP Diastolic Unit mmHg kPa Factory Default Alarm Limits*
Neonate Pediatric Low Limit High Limit Low Limit High Limit 35 4.7 90 50 6.7 Off 40 5.3 90 70 9.3 Off Adult Low Limit 40 5.3 85 High Limit 125 16.7 Off SPO2
*Allowoneleastsignificantdigittoaccommodatetheroundofferrorforcalculatedvalues. Percent Listing of Alarms Allalarmsarecategorizedashighpriority. WARNING If, during use, an alarm condition listed below results in a loss of patient monitoring capability, employ an alternate means as needed to prevent a lapse in patient monitoring;
otherwise, treatment of the patient could be delayed. NOTE In the tables below, abbreviations used in the Type column have these meanings:
C = conditional; L = latched; S = selectable; and, U = unlatched. Status and Technical Alarm Indications and Messages Thefollowingtablecontainsalistingofthestatusandtechnicalalarmindicationsandmessages. Displayed Message/
Indication ALARM SILENCED Message Location System message area NOTE No alarm sound generated Type Probable Cause Recommended Action U The Silence key was pressed. Wait until the 120-second countdown completes or press the Silence key. BAD PROBE SPO2 VS box U The SPO2 sensor is defective. Replace the SPO2 sensor. 916AlarmsExpressionMR200InstructionsforUse Message Displayed Message/
Location Indication CHANGE NiBP CUFF Notification area CHECK ALARM VOL System message area CHECK CO2 SAMPLING LINE COMM ERR CO2 CAL FAIL CO2 Hardware Fail Notification area NiBP VS box Notification area Notification area CO2 OUT OF RANGE Notification area CO2 SENSOR FAULTY Notification CO2 SENSOR OVER TEMP area Notification area CO2 WARMING UP Notification area CO2 ZERO REQUIRED Notification DEFL TO area NiBP VS box L U U L C C U L U U U L ERRATIC SPO2 VS box U Type Probable Cause Recommended Action The PATIENT type was changed and this message is displayed as a reminder. Power was just turned on, settings were recalled, or an adjustment was made to a sound setting Reduced flow has been detected by the CO2 system. NiBP internal error CO2 calibration has failed. CO2 module was not found during initialization The calculation value is greater than the upper CO2 limit . CO2 bench detected a hardware or sensor error. CO2 sensor is above the specified operating temperature. Ensure the correct cuff size is used for the patient. No action necessary. Allow the process to complete. Check for pinches or obstructions in the sampling line. Clear any pinch, or replace the accessory if necessary. Discontinue use of NiBP and contact technical support. Retry calibration. If the problem persists, contact technical support. Contact technical support. Perform patient readings to confirm physiological condition. Contact technical support. Confirm that the MR200 is operating within required environmental conditions (see Appendix A). If outside the specified range, move the cart to an area that is within limits. Displayed during the warm-up period of the CO2 module Zero calibration of the CO2 module is needed NiBP deflation has timed out. The SPO2 clip (or grip) is not properly applied to the patient, is not properly positioned, or the sensor is faulty. If the problem persists, stop all monitoring activities and contact technical support. Allow the module to complete its warm-up cycle, about two minutes. Perform a zero calibration; see page 7-
11. Check the patient. Check for proper cuff size and placement. Check the cuff and hoses for pinching. If the message persists, contact technical support. Check the alignment of the clip (or grip). Replace the SPO2 sensor. If the message persists, contact technical support. Discontinue use of NiBP and contact technical support. HW ERR NiBP VS box L NiBP hardware failure ExpressionMR200InstructionsforUseAlarms917 Displayed Message/
Indication HW FAIL Message Location NiBP VS box HW FAIL SPO2 VS box INFL TO NiBP VS box Internal CO2 Occlusion Notification area SPO2 VS box INTRFERNCE LEAD FAIL ECG trace area NOTE If the heart rate source is set to ECG, no HR value will be displayed in the ECG VS box. Type Probable Cause Recommended Action L L L U U U A hardware or other error has occurred in the NiBP system. A hardware or other error has occurred in the wSPO2 module. NiBP inflation has timed out. Discontinue use of NiBP and contact technical support. Replace the wSPO2 module. If the failure persists, immediately remove the MR200 and wSPO2 module from service and contact technical support, as the system must not be used on any patient requiring SPO2 measurement. Check the patient. Check the cuff and hoses for pinching or leaks. If the message persists, contact technical support. The internal filter has become polluted or disconnected. Interference due to misalignment of the attachments light source and receiver, or incorrect positioning of the attachment on the patient. A faulty or disconnected ECG lead is detected. NOTES An inoperative ECG parameter or wECG module is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. Contact technical support. Ensure that the module is placed outside of the MR bore. Reposition the wSPO2 module (see page 5-5. Check the alignment of the clip (or grip). Try a different limb or site. Replace the clip (or grip). Ensure all clip leads are connected to the Quadtrode electrode and that the ECG lead cable is properly connected to the wECG module. Also, ensure that the wECG module has sufficient battery power. If the problem persists, replace the ECG lead cable. 918AlarmsExpressionMR200InstructionsforUse Type Probable Cause Recommended Action U Reported within 10 seconds, the baseline offset of the ECG input signal is too large for the system to process and display the waveform. Replace the Quadtrode electrode. Displayed Message/
Indication LEAD SATURATION Message Location ECG trace area NOTE If the heart rate source is set to ECG, no HR value will be displayed in the ECG VS box. LOW PERF SPO2 VS box U NOTE No alarm sound generated Module Not Calibrated NiBP VS box MSMT FAIL NiBP VS box MSMT TO NiBP VS box NiBP:
COMMUNICATION ERROR NiBP: DEFLATION TIMEOUT NiBP: HARDWARE ERROR NiBP: INFLATION TIMEOUT Notification area Notification area Notification area Notification area L L L L L L L Accuracy may be compromised due to low perfusion. The tissue at the site may be too opaque, thick or cold. If the attachment is positioned on the finger, check the fingernails for nail polish, long or artificial fingernails. Remove any fingernail polish completely. Try another location, like a toe. Try rubbing or warming the limb. NiBP is not calibrated. Contact technical support. The NiBP measurement has failed. The NiBP measurement has timed out. Check the patient. Check for proper cuff size and placement. Check the cuff and hoses for pinching or leaks. If the message persists, contact technical support. Check the patient. Check for proper cuff size and placement. Check the cuff and hoses for pinching or leaks. If the message persists, contact technical support. Same as COMM ERR See COMM ERR for details. Same as DEFL TO See DEFL TO for details. Same as HW ERR See HW ERR for details. Same as INFL TO See INFL TO for details. ExpressionMR200InstructionsforUseAlarms919 Displayed Message/
Indication NiBP: MEASUREMENT FAILED NiBP: MEASUREMENT TIMEOUT NiBP: OVER PRESSURE NiBP: PRESSURE CORRECTION ERROR NiBP: RESIDUAL PRESSURE NO PROBE Message Location Notification area Notification area Notification area Notification area Notification area SPO2 VS box NOISE SPO2 VS box L L L L L U U NON-PULSAT SPO2 VS box U Type Probable Cause Recommended Action Same as MSMT FAIL See MSMT FAIL for details. Same as MSMT TO See MSMT TO for details. Same as OVR PRESS See OVR PRESS for details. Same as PRESS CORR See PRESS CORR for details. Same as RESID PRESS. See RESID PRESS for details. The SPO2 sensor is not present or is improperly connected to the wSPO2 module. Excessive patient motion;
MRI scan sequence; or, electrical interference is being experienced by the SPO2 system. The patients pulse is too weak for the system to report reliable SPO2 saturation and pulse measurements. Check the connection of the sensor to the module. Reconnect it; or if the connection is good, replace the sensor. Check for patient motion, especially at the monitored site. Ensure that the module is placed outside of the MR bore. Ensure the clip (or grip) is positioned so that it is not exposed to excessive levels of ambient light. Check the patients condition. Check the clip (or grip) position and alignment on the patient then re-
position or re-apply as necessary Try a different limb or site. Reduce the waveform size by choosing a setting in the ECG Scale menu. OVERSCALE ECG trace area NOTE No alarm sound generated U The ECG waveform is too large and the peaks are being clipped. OVR PRESS NiBP VS box L NiBP has exceeded the allowed pressure for the patient type. Ensure that the patient is immobilized and not applying pressure to the cuff. Check the cuff condition and placement on the patient. Make sure that the hose is not pinched. If the message persists, contact technical support. 920AlarmsExpressionMR200InstructionsforUse Displayed Message/
Indication PERFORMING CO2 ZERO PRESS CORR Message Location Notification area NiBP VS box PROBE OFF SPO2 VS box NOTE Alarm sounds only if reported after a valid numeric is displayed. PULSE?
SPO2 VS box RESID PRESS NiBP VS box REAL TONES DISABLED Notification area NOTE No alarm sound generated Type Probable Cause Recommended Action U L U U L U Displayed while performing CO2 zeroing. An NiBP pressure correction error has been detected. No action necessary. Allow the process to complete. Ensure that the patient is immobilized and not applying pressure to the cuff. Check the cuff condition and placement on the patient. The SPO2 attachment is not properly applied to the patient. Check the position of the clip (or grip) and its alignment on the patient;
reposition or reapply the clip (or grip). The clip (or grip) may not be applied optimally; or, the tissue at the application site may be too opaque. Residual pressure remains in the NiBP system. Displayed when in the SOUND ADJUST >
ALARMS menu Check the alignment of the clip (or grip). Try a different limb or site. Disconnect the NiBP hose and restart the procedure. Exit the menu. SEARCHING SPO2 VS box U NOTE Alarm sounds only if reported after a valid numeric is displayed. The SPO2 attachment was just applied to the patient or it has shifted position since attachment. If SPO2 was just applied, allow about 20 seconds for the system to lock on to a good pulse. Check the clip (or grip) position and reposition it if necessary. Replace the SPO2 sensor. If the message persists, contact technical support. ExpressionMR200InstructionsforUseAlarms921 Displayed Message/
Indication SIMULATION Message Location System message area NOTE No alarm sound generated Type Probable Cause Recommended Action L Simulation mode is running. Cycle power off and on. SOUND ON HOLD System message area U Power was turned on, or the Silence key was pressed. Wait until the 120-second countdown completes or press the Silence key. NOTE No alarm sound generated SUSPENDED System message area U NOTE No alarm sound generated Dialog box Dialog box WARNING Move monitor away from magnet. NiBP and CO2 (if installed) have been shut down. WARNING Persistent CO2 occlusion detected. Please clear occlusion and press OK to resume using CO2 WRONG PRB SPO2 VS box Communication and power status display area The Suspend key was pressed and alarms are now suspended. Press the Suspend key to exit the mode. U U U U The gauss limit has been exceeded, and now NiBP and CO2 can no longer function. Position the MR200 per the product labeling; see page 2-6. Reduced flow has been detected by the CO2 system for over 2 minutes. The SPO2 sensor connected to the wSPO2 module is not the correct type. No communication between the cart and wSPO2 module Check for pinches or obstructions in the sampling line. Clear any pinch, or replace the accessory if necessary. Afterward, press OK to restart the CO2 parameter. If the message persists, contact technical support. Attach the correct sensor to the module. Ensure that the wSPO2 module is set to the same network channel as the cart. If both are the same, use an alternate setting. If the indication persists, contact technical support. 922AlarmsExpressionMR200InstructionsforUse Displayed Message/
Indication Message Location Communication and power status display area Communication and power status display area Communication and power status display area Type Probable Cause Recommended Action U No communication between the cart and wECG module U Low cart battery Ensure that the wECG module is set to the same network channel as the cart. If both are the same, use an alternate setting. If the indication persists, contact technical support. Connect the cart to external power and allow the batteries to charge. Low module battery Install a charged battery into the module. U Physiological Alarm Indications and Messages Thefollowingtablecontainsanalphabeticallistingofphysiologicalalarmindicationsand messages. Displayed Message/
Indication Red flashing VS numeric, and waveform (if applicable)
- - -
Message Location VS box of associated parameter VS box of associated parameter NOTE Alarm sounds only if reported after a valid numeric is displayed. Type Probable Cause Recommended Action S U Alarm limit violation Check the patient. Parameter data once present is no longer available or a hardware failure has occurred. If occurring in the NiBP VS box, may indicate the measurement is out of range. If an alarm was generated:
Ensure that the wireless modules are still communicating; see page 2-16 for status indications. Ensure that all patient attachments are still connected. A parameters hardware may have experienced a problem; contact technical support. Perform patient readings to confirm physiological condition. If no alarm was generated:
Allow a few seconds for the system to complete its processes. A measurement value may be distorted or the signal may be inadequate; recheck all patient connections. ExpressionMR200InstructionsforUseAlarms923 Type Probable Cause Recommended Action U The heart rate measurement was greater than the upper measurement range of the parameter Check the patient. If the indication persists, contact technical support. U The heart rate measurement was less than the lower measurement range of the parameter Check the patient. If the indication persists, contact technical support. Displayed Message/
Indication OVR UND Message Location ECG or SPO2 VS box
(Replaces the numeric, except for ECG, which will alternate with a numeric value that is more than the highest specified heart rate.) ECG or SPO2 VS box
(Replaces the numeric, except for ECG, which will alternate with a numeric value that is less than the lowest specified heart rate.) 924AlarmsExpressionMR200InstructionsforUse CHAPTER 10 Trend Data and Printing Trend Data Thetrendfeature,accessedusingtheTRENDSkey
,providesoptionsthatincludetabular andgraphicaltrendsreportingandtrendarrowindications.Trenddataisusefulforassessinga patientoveraperiodoftime.Thetrenddatacapturesthefollowinginformation:
Timeanddateatwhicheachsetofmeasurementswasrecorded Heartratevalueandsource NiBP SPO2 CO2 CO2derivedrespiration Trenddataisstoredfromthetimeyoubeginmonitoringandcontinuesuntilthedataiscleared orthemonitoristurnedoff.Allstoredtrenddata,withtheexceptionoftabulartrenddata,will belostifpowerisremoved.Trenddatacandisplayedinaselectableformatandinterval. Tabular Trend Data Tabulartrenddataisprovidedonapagelayout. 1 2 3 4 5 6 10 9 78 ExpressionMR200InstructionsforUse TrendDataandPrinting101 Definition 1 2 3 4 5 6 7 8 9 10 Is the name of the dialog Are the CO2-derived respiration readings Are the CO2 readings Are the SPO2 readings Are the heart rate readings Is the page number, displayed oldest (first) to newest (last) Are the NiBP mean readings Are the NiBP systolic/diastolic readings Is the time of the reading Is the date of the reading Viewing Multi-Parameter Tabular Trend Data Toviewtabulartrenddataformultipleparameters Step 1 Action PresstheTRENDSkey
(whileinthenormalmode). TheHISTORYmenuappearsandthefirstpageoftrenddataare displayed. Turnthecontrolknobtoselectanyofthefollowingoptionsand thenpresstheknob:
2 PREVPAGE NEXTPAGE Forinformationabouttheseoptionsandsettings,seethe appropriatesectionsbelow. 3 Toviewotherpages,repeatstep2. Graphical Trend Data Graphicaltrenddataisplottedonameasuredvalueversustimescale.Upto24hoursof graphicaltrenddatacanbestored.After24hours,theoldestdataisdeletedtomakeroomfor newerdata. 102TrendDataandPrinting ExpressionMR200InstructionsforUse 2 3 4 1 6 5 2 3 4 Definition 1 2 Is the name of the graph Are the numeric values of the selected parameters (y-axes) and plotted in the same color Are the selected parameters (y-axis labels) Is the y-axis plot Is the plot grid Is the x-axis plot 3 4 5 6 Viewing Individual Trend Graphical Data Toviewgraphicaltrenddataforasingleparameter RotatethecontrolknobtohighlighttheVSboxofthedesiredparameterandthenpressthe TRENDSkey
. ExpressionMR200InstructionsforUse TrendDataandPrinting103 Viewing Multi Trend Graphical Data Toviewgraphicaltrenddataformultipleparameters Step 1 Action PresstheTRENDSkey
(whileinthenormalmode). TheHISTORYmenuappearsandthefirstpageoftrenddataare displayed. TurnthecontrolknobtoMULTITRENDSandthenpresstheknob. TheMULTITRENDSsubmenuappears. TurnthecontrolknobtoSELECTandthenpresstheknobtochoose theparametersusedintheplot. Turnthecontrolknobtoselectanyofthefollowingparameters thenpresstheknobtoselecttheparameter. HR NiBP SPO2 ETCO2 RESP[CO2]
Thiswillformtheyaxisoftheplot. Ifdesired,repeatstep4toselectadditionalparameters(uptofour canbeplottedsimultaneously).Thenturnthecontrolknobto RETURNandpresstheknob. TurnthecontrolknobtoTIMEBASEandthenpresstheknobtoset thetimebaseusedfortheplot. Turnthecontrolknobtoselectoneofthefollowingintervalsand thenpresstheknob. 2 3 4 5 6 7 20SEC 2HOURS 4HOURS 8HOURS 24HOURS 8 9 10 Thiswillbethexaxisoftheplot. TurnthecontrolknobtoMENUBACKandthenpresstheknobto positionthemenubehindthegraphforunobstructedviewing. TurnthecontrolknobtoCURSOR/ZOOMandthenpresstheknob toexamineindividualpointsintime. Whilethecursorisinthemostrightsideoftheplot,presstheknob againtoexitthezoomfunction. 11 PresstheMainkey toexitthemenu. 104TrendDataandPrinting ExpressionMR200InstructionsforUse HISTORY Menu TheHISTORYmenuprovidesoptionstoselectpages.Upto48trend recordscanbestored.Ahistoryfilecanbeviewedforallparameters.The elementscontainedinthehistoryfilepagearedescribedbelow. TochangesettingsintheHISTORYmenu Step Action 1 2 3 4 5 6 PresstheTRENDSkey
(whileinthenormalmode). TheHISTORYmenuappears.Currentsettingsaredisplayed. Turnthecontrolknobtoselectanyofthefollowingoptionsand thenpresstheknob:
PREVPAGE NEXTPAGE CLEARALL MULTITRENDS TRENDARROWS ARROWPERIOD Forinformationabouttheseoptions,seetheappropriatesections below. Turntheknobtothedesiredsettingoritemandthenpressthe knob. IfMULTITRENDSwasselected,gotostep5;otherwise,gotostep 7. Turnthecontrolknobtoselectanyofthefollowingoptionsand thenpresstheknob:
SELECT CURSOR/ZOOM TIMEBASE CLEARALL TRENDARROWS MENUBACK Forinformationabouttheseoptions,seeMULTITRENDS,below. Turntheknobtothedesiredsettingoritemandthenpressthe knob. ExpressionMR200InstructionsforUse TrendDataandPrinting105 Step Action 7 PresstheMainkey toclosethemenu. Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. PREV PAGE Displaysthepreviouspageofthehistoryfile. Todisplaythepreviouspageofthehistoryfile SeeViewingMultiParameterTabularTrendDataonpage102fordetails. NEXT PAGE Displaysthenextpageofthehistoryfile. Todisplaythenextpageofthehistoryfile SeeViewingMultiParameterTabularTrendDataonpage102fordetails. CLEAR ALL Removesalltrenddata.Astrenddataisretainedwhena newpatientisconnectedformonitoring,toavoidconfusion, allpreviouslyacquireddatashouldbeclearedpriorto connectionofanewpatient. Beforedataerasure,adialogboxwillpromptyoufor confirmation.Usethecontrolknobtohighlightthedesired actionandthenpresstheknobtoproceed. Toclearalltrenddata PresstheTRENDSkey.TurnthecontrolknobtoCLEARALLandpresstheknob. 106TrendDataandPrinting ExpressionMR200InstructionsforUse MULTI TRENDS Displaysagraphicalrepresentationofselectedmonitoredparameters. Thefollowingchoicesareavailable:
SELECTconfiguresuptofoursimultaneoustrendsusedtoplottheyaxisofthegraph. Thefollowingchoicesareavailable:
HRplotsheartrate NiBPplotsNiBP SPO2plotsSPO2 ETCO2plotsEtCO2 RESP[CO2]plotsCO2derivedrespiration CURSOR/ZOOMzoomsintothetrendchart,openingawindowwhereindividualpointsin timecanbeviewed.(Toexitthisfeature,turnthecontrolknobuntiltheverticallineisas fartotherightaspossibleandthenpresstheknob.) TIMEBASEconfigurestheintervalusedtoplotthexaxisofthegraph. Thefollowingchoicesareavailable:
20SEC(Default) 2HOURS 4HOURS 8HOURS 24HOURS CLEARALLdeletesalldatafromthetrendhistory. MENUBACKmovesthemenubehindthegraphwindow. TodisplaytheMultiTrendsgraphandsubmenu PresstheTRENDSkey.TurnthecontrolknobtoMULTITRENDSandpresstheknob. ExpressionMR200InstructionsforUse TrendDataandPrinting107 TREND ARROWS Controlsavitalsigntrendindication,whereatrendarrowisdisplayedalongsidetheVSbox(not availableforbellowsderivedrespiration)withameaningasdefinedinthetablebelow.(See page214foranexample.) Indication Meaning Rising Declining Stable None declared Thefollowingchoicesareavailable:
ONturnsonthetrendarrows. OFFturnsoffthetrendarrows.(Default) Todisplaytrendarrows PresstheTRENDSkey.TurnthecontrolknobtoTRENDARROWSandpresstheknob.Thenturn thecontrolknobtoON. WARNING Depending upon the ARROW PERIOD and measurement cycles of the vital signs, NiBP trend arrow indications may not be representative of the current condition of the patient. ARROW PERIOD Setsthetimeusedtocalculateanddeclarethedirectionforthetrendarrows. Thefollowingchoicesareavailable:
30SEC 1MIN 3MIN(Default) 5MIN 10MIN Tosetthearrowperiod PresstheTRENDSkey.TurnthecontrolknobtoARROWPERIODandpresstheknob.Thenturn thecontrolknobtothedesiredinterval. 108TrendDataandPrinting ExpressionMR200InstructionsforUse NOTE If a newly selected period is shorter than the previous period (and the arrows have been on for the longer of the two periods) then immediate recalculation using the new period will occur. Alternately, if the newly selected period is longer than the previous period, recalculation will occur using all available data. Print Functions WhenequippedwithanIP5printer,theMR200canprovidesingleordualwaveformstripcharts. NOTES If a printer-equipped IP5 is not installed or connected to the system, in the communication and power status display area on the LCD. For a listing of printer icons, see page 2-16. Any print command from the MR200 automatically initiates a 30-second print cycle at the IP5. Any print command initiated from the MR200 takes precedence over the IP5 print functions. will be displayed PRINTER Menu ThePRINTERSETUPoption(intheSETUPmenu)opensthePRINTERmenu,whichcontains optionsforprintersetupandcontrolwhentheMR200isequippedwithanoptionalIP5and printer.Forexpandedprintingoptionsnotcoveredinthismanual,consulttheIP5IFU. ExpressionMR200InstructionsforUse TrendDataandPrinting109
. PRINTER menu Setup key Control knob TochangesettingsinthePRINTERmenu Step Action 1 2 3 4 5 6 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoPRINTERSETUPandthenpresstheknob. ThePRINTERmenuappears.Currentsettingsaredisplayed. Turnthecontrolknobtoselectanyofthefollowingprinteroptions andthenpresstheknob:
TRACE1 TRACE2 TRACEDELAY Forinformation,seetheappropriatesectionsbelow. Turntheknobtothedesiredsettingandthenpresstheknob. Tochangeotheroptions,repeatsteps3and4. PresstheMainkey toclosethemenu. Alternative:TurntheknobtoRETURNandthenpresstheknob,or waitapproximately60seconds. 1010TrendDataandPrinting ExpressionMR200InstructionsforUse TRACE 1 Enablesthefirsttracetobeoutputbytheprinter.Thestripchartmaybeconfiguredtocontain oneortwowaveforms(seeTRACE2,below).Adescriptionofeachitemprintedonthestripchart isprovidedbelow. 1 2 3 4 5 6 7 11 10 9 8 Definition 1 2 3 4 5 6 7 8 9 10 11 Trace 1 parameter Date and time (formatted as MM/DD/YY-HH:MM:SS) Patient type Trace delay Trace speed Parameter information Values of active parameters at time of printing Trace 2 parameter information Trace 2 parameter Trace 2 waveform Trace 1 waveform Thefollowingchoicesareavailable:
ECG1(TraceA)(Default) ECG2(TraceB) SPO2(TraceC) RESP(CO2)(TraceD) ToprintaTrace1waveform EnterthePRINTERmenu.PressthecontrolknobtoselectTRACE1andpresstheknob.Scrollto thedesiredoutputandpresstheknob. ExpressionMR200InstructionsforUse TrendDataandPrinting1011 TRACE 2 Enablesthesecondtracetobeoutputbytheprinter. Thefollowingchoicesareavailable:
OFF(Default) ECG1outputstheTraceAwaveform.(Default) ECG2outputstheTraceBwaveform. SPO2outputstheTraceCwaveform. RESP(CO2)outputstheTraceDwaveform. ToprintaTrace2waveform EnterthePRINTERmenu.TurnthecontrolknobtoTRACE2andpresstheknob.Scrolltothe desiredoutputandpresstheknob. NOTE If TRACE 2 is Off, a single trace is printed using the full 40 mm width of the strip chart. When printing two traces, the waveform to grid ratio will not correspond to the waveform/scale indicator size displayed on the LCD. TRACE DELAY Setsadelayperiodfortheprintedtrace. Thefollowingchoices(inseconds)areavailable:
0(Default) 4 8 16 Tosetaprintingtimedelay EnterthePRINTERmenu.TurnthecontrolknobtoTIMEDELAYandpresstheknob.Scrolltothe desiredsettingandpresstheknob. 1012TrendDataandPrinting ExpressionMR200InstructionsforUse Cleaning and Maintenance CHAPTER 11 Environmental Requirements RoyalPhilipsHealthcareisconcernedaboutprotectingthenaturalenvironmentandtohelp ensurecontinuedsafeandeffectiveuseofthisproductthroughpropersupport,maintenance andtraining.RoyalPhilipsequipmentisthereforedesignedandmanufacturedtocomplywith relevantguidelinesforenvironmentalprotection.Aslongastheequipmentisproperlyoperated andmaintained,itpresentsnorisktotheenvironment.However,theequipmentmaycontain materialswhichcouldbeharmfultotheenvironmentifdisposedofincorrectly.Useofsuch materialsisessentialfortheimplementationofcertainfunctionsandformeetingcertain statutoryandotherrequirements. ThissectionoftheInstructionsforUseisdirectedmainlyattheuseroftheequipmentorsystem, thebodywithlegalauthorityovertheequipment.Operatorsarenotusuallyinvolvedindisposal, exceptinthecaseofcertainbatteries,seepage117. General Cleaning Guidelines KeeptheMR200andaccessoriesfreeofdust,dirtandpathogens.Aftercleaninganddisinfection, alwayschecktheequipmentcarefully.Stopusingequipmentthatshowssignsofdeteriorationor damage.Observethefollowinggeneralprecautionswhencleaning:
Alwaysdilutethecleaningsubstanceaccordingtothemanufacturersinstructionsoruse lowestpossibleconcentration. Neverallowliquidtoentertheequipment. Neverimmerseanypartoftheequipmentinliquid. Neverpourliquidontotheequipment. Neveruseabrasivematerialtowipetheequipment. NOTE For answers to questions regarding infection control:
Users inside USA, call us at (877) 468-4861 Users outside USA, call us at +31 (0) 499 378299 ExpressionMR200InstructionsforUseCleaningandMaintenance111 Cleanusingalintfreecloth,moistenedwithwarmwater(40C/104Fmaximum)andmildsoap, adilutednoncausticdetergentoralcoholbasedcleaningagent.Neverusestrongsolventssuch asacetoneortrichloroethylene.Stainscanberemovedbyscrubbingbrisklywithamoistened cloth.Ifdisinfectionisrequired,cleantheequipmentbeforedisinfectingit. UseonlytheRoyalPhilipsapprovedsubstancesandmethodslistedinthischaptertocleanor disinfecttheequipment.RoyalPhilipsmakesnoclaimsregardingtheefficacyofthelisted chemicalsormethodsasameansforcontrollinginfection.Warrantydoesnotcoverdamage causedbyusingunapprovedsubstancesormethods. Therecommendedtypesofdisinfectingagentsarelistedinthetablebelow.Wemakenoclaims regardingtheefficacyofthelistedchemicalsormethodsasameansforcontrollinginfection. Consultyourfacility'sInfectionControlOfficerorEpidemiologist.Forcomprehensivedetailson cleaningagentsandtheirefficacyrefertoGuidelinesforPreventionofTransmissionofHuman ImmunodeficiencyVirusandHepatitisBVirustoHealthCareandPublicSafetyWorkersissued bytheU.S.DepartmentofHealthandHumanServices,PublicHealthService,CentersforDisease Control,February1989.Alsorefertoanypoliciesthatapplywithinyourfacilityandcountry. Product Name Product Type Actichlor Plus CaviWipes Disinfectant Coverage Spray TB, TB Plus, HB Plus**
Sklar Disinfectant**
Sani-Cloth Plus Wipes**
*Followmanufacturer'sinstructionsformixing;werecommendasolutionof5,000ppm.
**Anyproductresidueshouldberemovedbywiping. Tablet*
Towelette Spray Towelette Towelette Cleaning the Cart and Modules WARNING Always disconnect the MR200 from AC power, and remove the batteries from the cart and the wireless modules, before performing any cleaning or maintenance. To avoid an electrical hazard, never immerse any part of the MR200 in any cleaning agent or attempt to clean it with liquid cleaning agents. FollowthegeneralguidelinestocleanthecartandthewECGandwSPO2modules.Alwaysturn offthecartandthemodulestoperformcleaning.Neverimmerseportionofthecartorthe modulesinfluidorattempttocleanthedevicesbydirectlyapplyingliquidcleaningagents. 112CleaningandMaintenanceExpressionMR200InstructionsforUse CAUTIONS Other than those specified in the preceding table, avoid ammonia-, phenol- and acetone-
based cleaners as they will damage the surfaces of the MR200. Disinfect the cart and modules as determined by your hospitals policy to avoid long term damage to the product. Do not permit liquid to contact the front or rear of the display panel. Do not permit liquid to drip into or around the LCD. Contact technical support if liquid enters any component. If the MR200 becomes accidentally wet during use, discontinue operation until all affected components have been cleaned and permitted to completely dry. Contact technical support if additional information is required. Tocleananddisinfectthecartandwirelessmodules Step 1 2 3 4 5 Action TurnoffthecartandunplugtheACpowercord.Removethe batteries,ifinstalled. Removethebatteryfromeachwirelessmodule. Removeallvisibledebrisfromthecartandwirelessmodulesusing soapandwater. CAUTIONS Never pour liquid onto the equipment. Cleanthecartandmodulesbythoroughlywipingthedevicesusing CaviWipesDisinfectanttowelettes.Discardtheusedtowelettes
(refertoyourfacility'sbiohazardprocedurefordisposal). NOTE Follow the instructions for use from the disinfectant manufacturer to clean the cart and modules. Disinfectthecartandmodulesbythoroughlywettingthedevices usingCaviWipesDisinfectanttowelettes.Discardtheused towelettes(refertoyourfacility'sbiohazardprocedurefor disposal). NOTE Follow the instructions for use from the disinfectant manufacturer to disinfect the cart and modules. ExpressionMR200InstructionsforUseCleaningandMaintenance113 Step 6 7 8 Action Allowthecartandthemodulestodry.(Norinsingisrequired.) Checkthecartandthemodulesforanyresidualdebris.Ifanydebris ispresent,repeatsteps3through6thenreexaminethecartand modulesbeforeproceeding. Checkthecartandmodulesfordamageandcontacttechnical supportifdamageisfound. Sterilizing the Cart and Wireless Modules Thecartandthemodulesarenotsterilizable;donotimmerseanypartofthesedevicesinfluidor attempttocleanthemwithliquidcleaningagents.Severedamage,notcoveredbythewarranty, willresult. Cleaning the Accessories Anyreusablepatientaccessory(suchasSPO2attachmentsandsensors,ECGcables,NiBPcuffs, chestbellows,etc.)mustbecleanedanddisinfectedbeforeinitialuse,andthenaftereachuse,to protectpatientsandpersonnelfromavarietyofpathogens.Usesoapandwater,andasuggested disinfectantandmethod,tocleananddisinfecttheaccessories.Thewarrantydoesnotcover damagecausedbyunapprovedsubstancesormethods. Disposableaccessoriesmustbediscardedandreplacedwithnewitems. WARNING Single-use devices, as indicated on the device packaging, should be disposed of after use and must never be reused.Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. CAUTIONS Never immerse an accessory in any cleaning fluid. Do not autoclave any part of the equipment. Disinfect the accessory as determined by your facilitys policy. NOTE Disposable SPO2 attachments: After some use, adhesive residue may accumulate at the fiber heads on the sensor cable. Remove carefully any residue with some alcohol. The glass fiber ends must always be clear and free from residuals. 114CleaningandMaintenanceExpressionMR200InstructionsforUse Tocleanareusableaccessory Step 1 2 Action Removetheaccessoryfromuse. Removeallvisibledebrisfromtheaccessoryusingsoapandwater. CAUTION Never pour liquid onto the accessory. 3 4 5 6 7 8 9 CleantheaccessorybythoroughlywipingitusingCaviWipes Disinfectanttowelettes.Discardtheusedtowelettes(refertoyour facility'sbiohazardprocedurefordisposal). NOTE Follow the instructions for use from the disinfectant manufacturer to clean the sensor. DisinfecttheaccessorybythoroughlywettingitusingCaviWipes Disinfectanttowelettes.Discardtheusedtowelettes(refertoyour facility'sbiohazardprocedurefordisposal). NOTE Follow the instructions for use from the disinfectant manufacturer to disinfect the sensor. Allowtheaccessorytodry.(Norinsingisrequired.) Checktheaccessoryforanyresidualdebris.Ifanydebrisispresent, repeatsteps2through5thenreexaminethesensorbefore proceeding. Checktheaccessoryfordamageanddiscardtheaccessoryif damageisfound;seepage116fordetails. Storetheaccessory;seepage116fordetails. Inspecttheaccessoryforanycracks,holes,tears,cuts,etc.that couldaffectoperationandreplaceasnecessary. Sterilizing the Accessories Theaccessoriesarenotsterilizable.Severedamage,notcoveredbythewarranty,willresult. ExpressionMR200InstructionsforUseCleaningandMaintenance115 Inspecting the Accessories for Damage Theaccessoriesareexposedtopotentiallydamagingsituationsduringuseandcleaning.Before eachuse,carefullyinspecttheaccessoriesforthefollowingsignsofdamage:
Cracks,holes,tears,gouges,cuts,etc. Cracksorothersignsofdamagetotheconnector,includingbentordamagedpins. WARNING Cracks, tears, cuts and gouges interfere with standard cleaning procedures and therefore pose a potential risk to patients and personnel. If you see any sign of damage to any accessory, immediately discontinue use. Storing the Accessories Thecarthasbuiltinstoragefeaturestohousewirelessmodulesandaccessoriesusedduring monitoring;seepage23. WARNING To reduce the spread of infection, do not store accessories directly on the MR200 handles. CAUTION When inserting or removing the accessories from the cart or wireless modules, only use the connector and never pull or apply excessive force or tension to any other portion of the device. Tostorethewirelessmodulesandsensorsandcables Whennotinuse,slidethewECGandwSPO2modulesintothemoduleholdersonthecart. Tostoretheotheraccessories Whennotinuse,loopsamplelinesandthenplacetheminthestoragebasketordrapethem overanoptionalaccessoryhook. Final Disposal Finaldisposaliswhentheuserdisposesoftheequipment(system,accessoriesandbatteries)in suchawaythatitcannolongerbeusedforitsintendedpurposes. 116CleaningandMaintenanceExpressionMR200InstructionsforUse WARNING Do not dispose of this product (or any parts of it) in industrial or domestic waste. The system may contain materials and hazardous substances that can cause serious environmental pollution. The system also contains privacy sensitive information. It is advisable to contact your Royal Philips Service Organization before disposing of this product. RoyalPhilipsHealthcaregivessupportfor:
Recoveryofreusableparts. Therecyclingofusefulmaterialsbycompetentdisposalcompanies. Safeandeffectivedisposalofequipment. Fordetaileddisposalinformation,gotothefollowingwebpage:
http://www.healthcare.philips.com/main/about/sustainability/recycling/pm.wpd Therecyclingpassportslocatedtherecontaininformationonthematerialcontentofthe equipment,includingpotentiallydangerousmaterialswhichmustberemovedbeforerecycling
(forexample,batteries). Disposal of the Device and Accessories TheMR200andaccessoriesaresubjecttostrictdisposalregulationsforuserandenvironmental safety.Neverdisposeofwasteelectricalandelectronicequipmentasunsortedmunicipalwaste. Collectitseparatelysothatitcanbesafelyandproperlyreused,treated,recycledorrecovered. WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the MR200 appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. Do not dispose of this product (or any parts of it) in industrial or domestic waste. The system may contain materials such as lead, tungsten or oil, or other hazardous substances that can cause serious environmental pollution. The system also contains privacy sensitive information. It is advisable to contact your Royal Philips Service Organization before disposing of this product. You can disassemble the MR200 and accessories as described in the service manual. Disposing of Batteries Thelithiumbatteriesfoundinthesystemandsomeoftheaccessoriesoroptionalequipment maybesubjecttostrictdisposalregulationsforuserandenvironmentalsafety.Observeand adheretoyourcurrentlocalregulationswhendisposingofbatteries. ExpressionMR200InstructionsforUseCleaningandMaintenance117 CAUTIONS Never heat or throw a battery into fire. Heating the battery will damage the safety circuitry, which can cause rupture or ignition of the battery. Never disassemble a battery. The batteries contain hazardous material that must be recycled or disposed of properly. (Refer to the disposal guidelines below.) Maintenance PeriodicmaintenancefortheMR200,asoutlinedbelow,mustbefollowed. CAUTION Annual preventative maintenance is recommended unless stated otherwise in the service manual. For proper equipment maintenance, perform the service procedures at the recommended intervals as described in the service manual. Testing CO2 Accuracy TheCO2flowrateaccuracyshouldbeverifiedbydirectmeasurementusingacalibratedflow meterevery12months.(SeeGASCALonpage1114.) CAUTION An internal leak may result in condensation within the system. If this is suspected or if condensation is observed, discontinue use and contact technical support. Testing the NiBP System TheNiBPsystemshouldbetestedatleastonceevery12monthstoensureproperoperation. WARNING Never initiate the LEAK TEST while the cuff is applied to a patient. Continuous cuff pressure can lead to patient injury. 118CleaningandMaintenanceExpressionMR200InstructionsforUse TotesttheNiBPsystemforleakage Step 1 Action Attachanormaladultcuffandinterconnecthose,oratestvolume totheMR200. PressthePATIENTkey
. ThePATIENTmenuappears. TurnthecontrolknobtoADULT(orPEDIATRIC)andthenpressthe knob. PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSERVICE(BIOMED)andpresstheknob. TheSERVICE(BIOMED)menuappears. TurnthecontrolknobtoNiBPTESTSandpresstheknob. TheNiBPTESTSmenuappears. TurnthecontrolknobtoLEAKTESTandthenpresstheknob. TheNiBPLEAKTESTdialogboxappears. Turntheknobtothedesiredactionandthenpresstoproceed. 2 3 4 5 6 7 8 9 10 ResultsareprovidedontheLCDastheroutineprogressesthrough thedifferenttests. ExpressionMR200InstructionsforUseCleaningandMaintenance119 Default Initialization ThesettingsfortheMR200canberestoredtofactorydefaultvalues. Step Action 1 2 3 4 5 6 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoDEFAULTSETUPSandpresstheknob. ScrolltoFACTORYandpresstheknob. Allcurrentsettingswillbelost. TurnofftheMR200. TurnontheMR200. Themonitorssettingsarereturnedtothefactorydefaultvalues. Updating Software Asrevisionstothesoftwarebecomeavailable,theMR200canbeupdated.Itisrecommended thatyousaveyoursettingspriortoupdatingsoftware,sothattheycanberestoredafterward;
seeSTORESETUPSonpage35. WARNING When performing software updates (or upgrades) to the operating software of the MR200, ensure that all remaining devices in the monitors network are at the same or a compatible software revision level. Failure to observe this requirement could result in compatibility conflicts, communication problems, etc. Toupdatetheoperatingsoftware Step 1 2 Action ConnectACpowertothecartandinsertatleastonefullycharged battery. Turnonthecartthenwaituntilthenormalmodeisdisplayed;see LCDonpage213. 1110CleaningandMaintenanceExpressionMR200InstructionsforUse Step 3 Action InserttheUSBprogramupdatedevicethatcontainsthedesired softwareintotheUSBport. USB port USB program update device 4 TheWPUProgramUpdatewindowappears. 5 6 7 8 9 Currentsoftwarerevisionsaredisplayed,whereanyneededupdate willbedenotedbyanasterisk. TurnthecontrolknobtoYESandthenpresstheknobtoproceed. Thesoftwareupdatebegins.Aprogressbarisdisplayedandwhen allapplicableprogramupdateshavefinished,theWPUProgram Updatewindowchangestoindicatecompletion. TurnoffthecartandremovetheUSBprogramupdatedevicefrom theUSBport. Pressandholdthecontrolknobwhileturningonpowertothecart. ObservetheLCD.Whenthecursormovestotheupperleftcorner ofthescreen(approximately1015secondsafterpowerup), releasethecontrolknobthenimmediatelypressandholdtheMain key
. Whenthecoldstartbannerismomentarilydisplayed,releasethe Mainkey
. TheMR200willboottothenormalmode. 10 Ifthecoldstartbannerwasnotdisplayed,repeatsteps79. ExpressionMR200InstructionsforUseCleaningandMaintenance1111 Step Action 11 PresstheSetupkey
. 12 13 14 TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSERVICE(BIOMED)andthenpressthe knob. TheSERVICE(BIOMED)menuappears.Currentsettingsare displayed. WithS/WREVhighlighted,pressthecontrolknob.Verifythatthe displayedREVISIONINFORMATIONincludestheversionnumberfor thesoftwarethatwasupdated. SERVICE(BIO-MED) Menu TheSERVICE(BIOMED)menucontainssoftwareandfirmware informationaboutthesystemandoptionsforpressure,diagnostics andconfiguration. NOTE Some SERVICE(BIO-MED) menu options require entry of a password for access. For password assistance, contact technical support. For details regarding these password-protected options, reference the service manual. 1112CleaningandMaintenanceExpressionMR200InstructionsforUse ToentertheSERVICE(BIOMED)menu Step Action 1 2 3 4 PresstheSETUPkey
. TheSETUPmenuappears. TurnthecontrolknobtoMONITORSETUPandthenpresstheknob. TheMONITORmenuappears.Currentsettingsaredisplayed. TurnthecontrolknobtoSERVICE(BIOMED)andthenpressthe knob. TheSERVICE(BIOMED)menuappears.Currentsettingsare displayed. Turnthecontrolknobtoselectanyofthefollowingoptionsand thenpresstheknob:
S/WREV SIMULATIONMODE NiBPTESTS GASCAL SERVICEUTILITIES SYSTEMCONFIG Forinformationabouttheseoptions,seetheappropriatesections below. 5 PresstheMainkey toclosethemenu. Alternative:TurntheknobtoRETURNandthenpresstheknob. S/W REV Opensawindowthatcontainsrevisionlevelandbuilddate informationforthesoftwarecomponents.(Toclosethewindow, pressthecontrolknoborwait60seconds.) SIMULATION MODE ExpressionMR200InstructionsforUseCleaningandMaintenance1113 PlacestheMR200intosimulationmode. Toentersimulationmode Pressthecontrolknob.Adialogboxwillpromptyoufor confirmation.Usethecontrolknobtohighlightthedesiredaction andthenpresstheknobtoproceed. Whileinsimulationmode,toinitiatesimulatedNiBPfunctions,pressthe NiBPkey. Toexitsimulationmode Turnoffthepowerswitch. WARNING The MR200 is equipped with a simulation mode that displays computer generated data for training or demonstration. As a safety feature, SIMULATION is displayed and appears on all printouts while in simulation mode. Do not attach a patient to the MR200 when in simulation mode and never activate simulation mode when a patient is connected. The MR200 will not monitor patients while in the simulation mode. Activating simulation mode when a patient is connected will result in a lapse in patient monitoring and could result in a delay in treatment. NiBP TESTS AccessesNiBPcalibrationandtestingfunctions. CALIBRATEperformscalibrationoftheNiBPsystem.(Passwordrequired) LEAKTESTteststheNiBPsystemforpressureleaks. Toperformtheleaktest Seepage118. STATICTESTteststhepressureoftheNiBPsystem.(Passwordrequired) GAS CAL AccessestheCO2calibrationandtestingfunctions. NOTE Wait 2 minutes for CO2 warm-up before calibrating or performing an accuracy check. Thefollowingchoicesareavailable:
1114CleaningandMaintenanceExpressionMR200InstructionsforUse ZEROCALperformsazerocalibrationoftheCO2system.(Alsoseepage711.) Tostartzerocalibration EntertheSERVICE(BIOMED)menu.TurnthecontrolknobtoGASCALandpresstheknob. ScrolltoZEROCALandpresstheknob. CO2ACCURACYCHECKteststheCO2 function(a5%sourcemustbeconnected). ProvidesaCO2waveformvalue(asa percentage),anatmosphericpressure readingandanumericCO2value(in mmHg). Toperformanaccuracycheck Connectthe5%CO2sourcetotheCO2port.EntertheSERVICE(BIOMED)menuandscroll toGASCAL.PressthecontrolknobthenscrolltoCO2ACCURACYCHECKandpressthe knobagain.(Awarningdialogwillappear:CO2BENCHSHOULDBEWARMEDUPPRIORTO STARTINGACCURACYTEST.Pressthecontrolknobwhenreadytoproceed.) NOTE During the accuracy check, to alert you that the indicated values are not actual patient numerics, the following dialog box message will be displayed: CO2 test in progress. Do not use CO2 values for patient monitoring during test. Pressing close will cancel test. SERVICE UTILITIES Accessesservicerelatedfunctions(passwordrequired);seetheservicemanualfordetails. SYSTEM CONFIG ConfigurestheparametersandoptionsoftheMR200.(Forpasswordprotectedfunctions,see theservicemanualfordetails.) ExpressionMR200InstructionsforUseCleaningandMaintenance1115 LANGUAGEsetsthelanguagedisplayedbytheMR200(tomaketheselectioneffective, cyclepoweraftersavingyourchanges):
ENGLISH(Default) DEUTSCH ESPANOL FRANCAIS PORTUGUES(Br) ITALIANO DANSK SVENSKA NORSK NLD PRESSUREUNITSsetstheunitofmeasureforNiBPreadings:
mmHgprovidesreadingsinmillimetersofmercury.(Default) kPaprovidesreadingsinkilopascals Repair TheMR200containsnouserserviceableparts.Allrepairsmustbeperformedbytrainedservice personnel.Allrepairsonproductsunderwarrantymustbeperformedbyauthorizedpersonnel orinanauthorizedServiceandRepairCenter.Unauthorizedrepairswillvoidthewarranty. WARNING A shock hazard exists if the MR200 is operated without covers. 1116CleaningandMaintenanceExpressionMR200InstructionsforUse IftheMR200failstofunctionproperlyorrequiresmaintenance,contacttechnicalsupport:
1877INVIVO1 or 18774684861 Internationally,pleasecontactyourKeyMarketrepresentative.Foracurrentlisting,goto www.invivocorp.com CAUTIONS This product, or any of its parts, must not be repaired other than in accordance with written instructions provided by Invivo (Royal Philips), or altered without prior written approval. No repair should ever be undertaken or attempted by anyone not having a thorough knowledge of the repair of Invivo (Royal Philips) patient monitoring systems. Only replace damaged parts with components manufactured or sold by Invivo (Royal Philips). Contact the Technical Service and Repair Center for assistance and service. CAUTION The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Invivo (Royal Philips) or its authorized service personnel. Passing This Product on to Another User Ifthisproductistobepassedontoanotheruserwhoistouseitforitsintendedpurpose,thenit shouldbepassedoninitscompletestate.Inparticular,theexistingusershouldmakesurethatall theproductsupportdocumentationincludingallInstructionsforUsearepassedontothenew user.AnewusershouldbemadeawareofthesupportservicesthatRoyalPhilipsHealthcare providesforinstalling,commissioningandmaintainingtheequipmentorsystem,andforthe comprehensivetrainingofoperators.Existingusersmustbearinmindthatpassingonmedical electricalequipmenttonewusersmaypresentserioustechnical,medical,privacyandlegalrisks. Theoriginalusermayremainliableeveniftheequipmentisgivenaway. ExistingusersarestronglyadvisedtoseekadvicefromtheirlocalRoyalPhilipsHealthcare representativebeforeagreeingtopassonanyequipment. Oncetheequipmenthasbeenpassedontoanewuser,theprevioususermaystillreceive importantsafetyrelatedinformation,suchasservicebulletinsandfieldchangeorders.Inmany jurisdictions,thereisacleardutyontheprevioususertocommunicatesuchsafetyrelated informationtonewusers. ExpressionMR200InstructionsforUseCleaningandMaintenance1117 PrevioususerswhoarenotableorpreparedtodothisshouldinformRoyalPhilipsHealthcare aboutthenewuser,sothatRoyalPhilipsHealthcarecanprovidethenewuserwithsafetyrelated information. Packaging the MR200 TopackagetheMR200forshipment,usetheMR200packingmaterialstosafelytransportthe monitor. CAUTION If shipment of the MR200 is required, batteries must be removed prior to transport. TopacktheMR200 Step 1 2 Action InalocationoutsideoftheMRmagnetroom,ensurethatpoweris disconnectedandthatbothbatteriesareremovedfromthecart. CovertheLCD.InstallfoamAovertheupperportionofthecart. 1118CleaningandMaintenanceExpressionMR200InstructionsforUse Step 3 Action Withthecrateorientedasshown,placeitintoanuprightposition. Rollthecartintothecrate. 4 Carefullylowerthecrate.SlidefoamBintofoamCtheninsertit betweenthebaseofthecartandthecrate. 5 InsertfoamDintofoamA,andinsertfoamEbetweenfoamCand thecrate. ExpressionMR200InstructionsforUseCleaningandMaintenance1119 Step 6 Action Placethelidonthecrate. 7 Installalltheclipsintothelidonthecrate,ensuringthateachis locked. 1120CleaningandMaintenanceExpressionMR200InstructionsforUse APPENDIX A Specifications Patient Safety General ConformstoANSI/AAMIES606011.CertifiedtoCAN/CSAC22.2No.606011. Conformsto93/42/EECasamendedby2007/47/EEC Defibrillatorprotectionupto5KV Accordingtodegreeofprotectionagainstharmfulingressofwater:ordinaryequipment,IPX0(enclosedequipment withoutprotectionagainstingressoffluids) Whereappropriate,theequipmentcompliestoworldwidestandardsforsafetyandperformanceofeachsystem feature,whenconsideringtheindicationsforusewithintheMRenvironment.Thisequipmentcompliestothe followinginternationalindustrystandardsforsafetyandperformance:
IEC606011,GeneralRequirementsforSafetyofMedicalElectricalEquipment IEC6060112,GeneralRequirementsforSafetyElectromagneticCompatibility IEC6060116,GeneralRequirementsforSafetyCollateralStandard:Usability IEC6060118,GeneralRequirements,TestsandGuidanceforAlarmSystemsinMedicalElectricalEquipment andMedicalElectricalSystems IEC60601227,ParticularRequirementsforSafetySpecificationforElectrocardiographicMonitoring Equipment IEC60601249,ParticularRequirementsforSafetySpecificationforMultifunctionPatientMonitoring Equipment IEC80601230,MedicalElectricalEquipmentPart230:ParticularRequirementsfortheSafety,Including EssentialPerformance,ofAutomaticCyclingNonInvasiveBloodPressureMonitoringEquipment ISO80601261,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential PerformanceofPulseOximeterEquipmentforMedicalUse ISO80601255,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential PerformanceofRespiratoryGasMonitors ISO109931,BiologicalEvaluationofMedicalDevicesPart1:EvaluationandTesting ISO109935,BiologicalEvaluationofMedicalDevicesPart5:TestsforCytotoxicity:Invitromethods ISO1099310,BiologicalEvaluationofMedicalDevicesPart10:TestsforIrritationandDelayedType Hypersensitivity ExpressionMR200InstructionsforUseSpecificationsA1 Additionally,thisequipmentcompliestothefollowingnationalorregionalindustrystandardsforsafetyand performance:
1999/5/EC,Radio&TelecommunicationsTerminalEquipmentDirective SAAAS/NZS3200.1.2,GeneralRequirementsforSafetyElectromagneticCompatibility ANSI/AAMIEC13:2002/(R)2007,CardiacMonitors,HeartRateMeters,andAlarms ANSI/AAMISP10:2008,Manual,Electronic,orAutomatedSphygmomanometers 2006/66/EC,BatteryDirective UL2054:2004Secondarycellsandbatteriescontainingalkalineorothernonacidelectrolytes,Standardfor HouseholdandCommercialBatteries IEC62133:2002,Secondarycellsandbatteriescontainingalkalineorothernonacidelectrolytes,Standardfor HouseholdandCommercialBatteries 2002/96/EC,DirectiveonWasteofElectricalandElectronicEquipment ASTMF250308,StandardPracticeforMarkingMedicalDevicesandotherItemsforSafetyintheMR Environment ASTMF205206,StandardTestMethodforMeasurementofMagneticallyInducedDisplacementForceon MedicalDeviceinMREnvironment Power Requirements, Cart OperatingVoltageRange FrequencyRange Current PowerConsumption,Maximum Battery Type OperationTime ChargeTime MinimumVoltage
(Fornormaloperation) 100VACto240VAC 47Hzto63Hz 1.5A@115VAC/0.7A@240VAC 65Watts Cart:LithiumIon Module:Lithiumpolymer Cart:Maximumoperationtimeisapproximately8hourswhenECG andSPO2areon,CO2isoff,andNiBPisrunningat5minute intervals(timemaybereducedbyupto2hoursundercertain conditions,suchasrunningshorterNiBPcycles).Withthecartoff, insertedandfullychargedbatterieswillnotcompletelydischarge foratleast72hours. Module:Approximateoperationtimeofthebatteryis8hours. Cart:Torechargeafullydischargedbatteryisapproximately12 hourswiththeMR200turnedoff. Module:Torechargeafullydischargedbatteryisapproximately3 hours. Cart:14.8V Module:3.4V A2SpecificationsExpressionMR200InstructionsforUse Environment OperatingTemperatureRange Storage/TransportTemperatureRange RelativeHumidityRange OperatingAltitudeRange Storage/TransportAltitudeRange Dimensions and Weights
(Allmeasurementsmadewithoutaccessories) Height Width Depth Weight Liquid Crystal Display Type ScreenSize SweepSpeed WaveformDisplayMode WaveformDisplayHeight FullScreenDisplayHeight Batteryindication Alarmindication 10Cto35C(50Fto95F) Batteries:0Cto40C(32Fto104F) Cart:20Cto50C(4Fto122F) Wirelessmodules:25Cto75C(13Fto167F) Accessories:20Cto60C(4Fto140F)
(Whenstoringortransportingintemperaturesbeyondtheranges specifiedabove,removethedesignatedcomponentandstoreor moveitappropriately.) 15%to80%,noncondensing Fromsealevelupto10,000feet(3048m)(708mbar) From1020mbarto708mbar Cart:54.22inches(137.71cm) WirelessECGmodule:4.7inches(11.9cm) WirelessSPO2module:5.5inches(13.9cm) Cart:22.15inches(56.26cm) WirelessECGmodule:2.5inches(6.4cm) WirelessSPO2module:2.5inches(6.4cm) Cart:25.25inches(64.14cm) WirelessECGmodule:0.91inches(2.3cm) WirelessSPO2module:0.91inches(2.3cm) Cart:74.06pounds(33.59kg) WirelessECGmodule:5.4ounces(158.8g) WirelessSPO2module:5.4ounces(158.8g) 800x600pixels,color 12.1inches(30.7cm)diagonal ForECGandSPO2,aspeedof25mm/secondgives9.2secondsof displaytime,while50mm/secondgives4.6seconds. Forrespiration,aspeedof0.33,1.56,3.13,6.25,12.5or25mm/
secondisused. Fixedtrace,movingerasebar 19mm 75mm Timeremaining,redlowwarning Onehertzflashingfrequencywith50percentdutycycle,visibleat 4metersandlegibleat1meter(assumingavisualacuityof20/20 andwithnolineofsightobstructions). ExpressionMR200InstructionsforUseSpecificationsA3 Time Alarms ECG HeartRate Displayed Parameters Batterybackedquartzcrystalclock Highandlowlimitsselectableforpatientparameters ECGwaveformscale,displayedleads(2) NormallyderivedfromECG.Maybemanuallyselectedtobe derivedfrompulseoximetry,orautomaticallyinorderofpriority. PulseOximeter Pulserate,pulsewaveformandpercentsaturation Trends CO2 NiBP RespirationRate Heartrate,respirationrate,NiBP(systolic,mean,diastolic),CO2 andSPO2 BothendtidalandinspiredCO2 Pressures(systolic,mean,diastolic)andstatus RespirationratederivedfrombellowsorCO2 ECG ECG Amplifier Protectedagainstdefibrillatorandelectrosurgerypotentials StandardLeadConfigurations LeadFail ECGInputImpedance Heart Rate Range Accuracy Resolution Cardiotach Sensitivity(Monitorfilter) Bandwidth TallTWaveRejectionCapabilityforHeartRate Indication I,II,III,AVR,AVL,AVF Passive,sensingsignalimbalance
>2.5M(accordingtoIEC60601227,50.102.3) 30to249BPM(Adult) 30to300BPM(Neonate,Pediatric) IntheabsenceofanMRIgradientartifact:1%or1BPM, whicheverisgreater. InthepresenceofanMRIgradientartifact:1%from30200 BPM,1.5%from200250BPM,and(neonatalonly)2.0%from 251300BPM 1BPM AdultECGmode:>200uV Neonate/PediatricECGmode:>100uV Monitor:0.5Hzto40Hz 2mVwitha1mVQRSamplitude A4SpecificationsExpressionMR200InstructionsforUse Alarm Limits (HR) Lower Upper Test/Calibrations SquareWaveTestSignal ECG Supplemental Information, as required by IEC 60601-2-27 HeartRateAveragingMethod Offor30to249 60to249oroff 60BPM1BPM,1mV10%
Meanfilteringisappliedtotheoutputofthemedianfilterofa continuouslyupdatinggroupofQRScomplexes.TheECGheart ratenumericisupdatedtwiceasecond. TimetoAlarmforTachycardia B1VentTachycardia 1mVpp,206BPM B2VentTachycardia 2mVpp,195BPM Gain0.5(12.03,11.04,14.1,11.8,11.4)Average:12.1sec(The monitoringsystemmaytemporarilyexitthealarmcondition duringthearrhythmiawaveformduration.) Gain1.0(11.9,11.6,9.2,9.6,10.9)Average:10.6sec Gain2.0(8.8,9.1,10.3,9.4,12.1)Average:9.9sec Gain0.5(9.0,10.4,12.3,8.1,10.4)Average:10.0sec Gain1.0(8.4,7.7,12.5,7.7,8.3)Average:8.9sec Gain2.0(9.7,12.6,8.9,11.8,8.3)Average:10.3sec NOTE Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The alarm condition response time of some arrhythmia complexes may be affected by MRI gradient artifacts. ResponseTimeofHeartRateMetertoChange inHeartRate HeartRateMeterAccuracyandResponseto IrregularRhythm HRchangefrom80BPMto120BPM:8.3secaverage HRchangefrom80BPMto40BPM:7.9secaverage A1:Ventricularbigeminy:40BPM A2:Slowalternatingventricularbigeminy:30BPM A3:Rapidalternatingventricularbigeminy:115125BPM A4:Bidirectionalsystoles5885BPM NOTE Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The accuracy of the indicated heart rate may be affected by MRI gradient artifacts. ExpressionMR200InstructionsforUseSpecificationsA5 Pulsetonepitchismodulatedbythesaturationvalue Pulse Oximeter SaturationRange SaturationAccuracy PulseMeasurementRange PulseAccuracy WavelengthRange EmittedLightEnergy PulseOximeterCalibrationRange Alarm Limits Lower Upper WhenHRisderivedfromSPO2 Lower Upper 0to100%
3%at70%to100%
30BPMto250BPM 2%or1BPM,whicheverisgreater 500nmto1000nm
<15mW 70%to100%
Offor50to99 70to99oroff Offor30to249 60to249oroff NOTE Measurement validation: SPO2 accuracy validated in human studies against arterial blood sample reference measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70100 percent SPO2 were studied. The population characteristics for those studies were:
about 50% female and 50% male subjects 1927 years of age light to black skin tones A functional tester cannot be used for accuracy assessment of a pulse oximeter monitor; however, it can demonstrate that a pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular accuracy specification. SPO2 measurements are statistically distributed; therefore, in accordance to ISO 9919:2005, it is possible that only two-thirds of the measurements will fall within 3 percent of the value measured by the CO-Oximeter. A6SpecificationsExpressionMR200InstructionsforUse General PatientTypes Pneumatic Systems CuffInflationPressure OverpressureProtection UnitofMeasure Measurement Range Systolic Adult Pediatric Neonate Mean Adult Pediatric Neonate Diastolic Adult Pediatric Neonate Accuracy PressureMeasurementAccuracy PressureMeasurementResolution PressureTransducerRange Non-Invasive Blood Pressure Oscillometrictechnology(withaninflatablecuff)determines systolic,diastolicandmeanarterialpressures Adult,PediatricandNeonate Initial:165mmHgforAdult,130mmHgforPediatric,and100 mmHgforNeonate(allpressuresare15mmHg) SubsequentinflationpressuresdeterminedbylastNiBP measurement Automaticreleaseofcuffpressureifinflationpressureexceeds300 mmHgforAdultandPediatricmodes,and150mmHgforNeonate mode mmHgorkPa 30mmHgto270mmHg 30mmHgto180mmHg 30mmHgto130mmHg 20mmHgto255mmHg 20mmHgto160mmHg 20mmHgto120mmHg 10mmHgto245mmHg 10mmHgto150mmHg 10mmHgto100mmHg Maximummeanerror5mmHgwithastandarddeviationofless than8mmHg 1mmHg 0to300mmHg ExpressionMR200InstructionsforUseSpecificationsA7 Alarm Limits Systolic Adult&Pediatric Lower Upper Neonate Lower Upper Mean Adult&Pediatric Lower Upper Neonate Lower Upper Diastolic Adult&Pediatric Lower Upper Neonate Lower Upper Modes Manual Automatic Offor46to254 46to254oroff Offor46to124 46to124oroff Offor26to239 26to239oroff Offor26to94 26to94oroff Offor16to224 16to224oroff Offor16to84 16to84oroff Immediateuponoperatorcommand Determinationsautomaticallymadewithselectableintervalsof1, 2,2.5,3,5,10,15,20,30and45minutes;and,1,2and4hours A8SpecificationsExpressionMR200InstructionsforUse Sidestream,nondispersiveinfraredabsorptiontechnique.Includingmultiplefiltrationsystemandmicroprocessor logiccontrolofsamplehandlingandcalibration. CO2 (Optional) Output CO2UnitofMeasure InitializationTime InspiredCO2Measurement CO2Accuracy
(Allmeasurementsatgastempof25C) CO2MeasurementRange
(InwhichtheCO2accuracyspecificationismet) CO2Resolution CO2Stability CO2waveform,EtCO2andFiCO2numericvalues,andrespiration rate mmHgorkPa Waveformdisplayedinlessthan20seconds,atanambient temperatureof25C;fullspecificationsattainedwithin2minutes Range:3mmHgto50mmHg Method:LowestreadingoftheCO2waveformintheprevious20 seconds 4mmHgor12%,whicheverisgreater,afterthespecified warmupperiod 0to76mmHgforrespirationratesrangingfrom4to60breaths perminute,inclusive 1mmHg ShortTermDrift:Driftnottoexceed0.8mmHgover4hours LongTermDrift:Accuracyspecificationmaintainedovera120 hourperiod ZeroCalibrationInterval FlowRate RespirationAccuracy RespirationRateRange
(Inwhichtherespirationaccuracyspecification ismet) Automaticoruserrequested 50mL/minute10mL/minute 1breathor3%whicheverisgreater 4to100breathsperminute,inclusive RespirationResolution 1breathperminute Response(Rise)Time Adult&Pediatric Neonate
(Asmeasuredfromthepatientgasinputofthe completepneumaticcircuit[includingtubing], from10%to90%ofthemeasuredCO2levels) 800ms 440ms Compensations
(AutomaticCO2ambientpressure compensation400to800mmHg) CompensationsforexpiredO2Balancegas(N2,N2O,O,He)and AnestheticAgentsB Usesgascompensationinformationtocorrecttherawcarbon dioxidevalue ExpressionMR200InstructionsforUseSpecificationsA9 AnestheticAgentEffects
(MACLevels) CrosssensitivityCompensationError*
AnestheticAgentSensitivityA(uncompensated):Accuracy specificationwillbemaintainedforhalogenatedanestheticagents presentatacceptedMAC(MinimumAlveolarConcentration) clinicallevels. AnestheticAgentSensitivity(compensated):Testingatagent levelsdefinedbyacceptedregulatorystandards(i.e.,ISO21647, ASTMF1456,IEC/CDV60601255)currentlyinprocess. 0to40mmHg:1mmHgadditionalerror 41to70mmHg:2.5mmHgadditionalerror 71to100mmHg:4mmHgadditionalerror 101to150mmHg:5mmHgadditionalerror
*AdditionalworstcaseerrorwhencompensationforO2,N2O, anestheticagents,orheliumiscorrectlyselectedfortheactual fractionalgasconstituentspresent. Alarm Limits EndtidalCO2 Lower Upper InspiredCO2 Respiration Lower Upper A. GASorVapor Offor5to60 5to80oroff 25(Fixed) Offor4to40 20to99oroff Halothane Enflurane Isoflurane Desflurane MACLevel%(v/v)
(FromOlivierC.Wenker:ReviewofCurrentlyUsedInhalationAnesthetics:PartI.TheInternetJournalofAnesthesiology,1999,Volume 3Number.) 1.68 2.00 6.30 0.74 B. Measured Gas N20 NE@
60%
Carbon Dioxide NoEffect(NE) QuantitativeEffectsofGasorVapor HAL ENF ISO SEVO Xenon Helium DES Ethanol Isopropanol Acetone Methane NE@
4%
NE@
5%
NE@
5%
NE@
5%
ME1
@80%
NE@
50%
ME2
@15%
NE@
0.1%
NE@
0.1%
NE@
0.1%
NE@
1%
MinimalEffect1(ME1)=NegativelybiasCarbonDioxidevaluesbyuptoanadditional5mmHgat38mmHg MinimalEffect2(ME2)=Concentrationsgreaterthan5%willpositivelybiasCarbonDioxidevaluesbyuptoanadditional3mmHgat 38mmHg
*Metereddoseinhalerpropellants:Unspecified A10SpecificationsExpressionMR200InstructionsforUse RespirationRateMeasurementRange 0to60breathsperminute Bellows Respiration RespirationRateResolution RespirationRateAccuracy 1breathperminute 1breathperminute Gating Connector PinDesignator A B C D F G H J SignalName DIGITALGATINGPULSE SIGNALGROUND RESPANALOG ECG1VANALOG NEGATIVEGATINGPULSE SPO240mVANALOG ECG1mVANALOG SPO22VANALOG E,K,L,M,N,O UNUSED Wiringview DescriptionandCharacteristics ECG/SPO2digitalgatingpulse Peaktopeakvoltage:3.3Vto5.0V Pulseduration:103ms Returnvoltagereferenceforallothersignalpins Analogrespirationgatingwaveformsignal Maximumoutputvoltage:5V Maximumcurrent:5mA Peaktopeaksignalvoltage:1V AnalogECG1Voltwaveformsignal Outputsignalscaling:1V/mV Maximumoutputvoltage:5V Maximumcurrent:5mA ECG/SPO2negativedigitalgatingpulse Peaktopeaksignalvoltage:3.3Vto5.0V AllothersignalcharacteristicssameasPinA(above) SPO2IR/redanaloggatingwaveformsignal Signalscaling:1V/mV Maximumoutputvoltage:40mV ECGanaloggatingwaveformsignal Signalscaling:1mV/mV Maximumcurrent:5mA Maximumoutputvoltage:20mV SPO2IR/redanaloggatingwaveformsignal,maximumoutput voltage:2V Unusedpins ExpressionMR200InstructionsforUseSpecificationsA11 A12SpecificationsExpressionMR200InstructionsforUse APPENDIX B Warranty Warranty Statement KoninklijkePhilipsN.V. warrantsthisproduct,otherthanitsconsumableparts,tobefreefrom defectsinmaterialsandworkmanshipforaperiodoftwelve(12)monthsfromthedateof originaldeliverytothebuyerortobuyer'sorder,providedthatsameisproperlyoperatedunder conditionsofnormaluse,andthatperiodicmaintenanceandserviceisperformed.Thissame warrantyismadeforaperiodofninety(90)daysonconsumableparts.Thiswarrantyshall becomenullandvoidiftheMR200hasbeenrepairedbysomeoneotherthanKoninklijkePhilips N.V. oriftheproducthasbeensubjecttomisuse,accident,negligenceorabuse. KoninklijkePhilipsN.V.ssoleobligationunderthiswarrantyislimitedtorepairinganMR200 whichhasbeenreportedtotheTechnicalServiceCenterduringnormalbusinesshoursand shippedtransportationprepaid.KoninklijkePhilipsN.V. shallnotbeliableforanydamages includingbutnotlimitedtoincidentaldamages,consequentialdamagesorspecialdamages. Thiswarrantyisinlieuofanyotherwarranties,guaranteesorconditions,including merchantabilityorfitnessforaparticularpurpose.Theremediesunderthiswarrantyare exclusiveandKoninklijkePhilipsN.V. neitherassumesnorauthorizesanyonetoassumeforitany otherobligationinconnectionwiththesaleorrepairofitsproducts. KONINKLIJKEPHILIPSN.V. PRODUCTSCONTAINPROPRIETARYCOPYRIGHTEDMATERIAL. ALLRIGHTSRESERVED ExpressionMR200InstructionsforUseWarrantyB1 B2WarrantyExpressionMR200InstructionsforUse APPENDIX C Regulatory Information European Union Declaration of Conformity ToobtainacopyoftheDeclarationofConformitytotheEuropeanUnionMedicalDevice Directive(93/42/EEC)andRadio&TelecommunicationsTerminalEquipmentDirective(1999/5/
EC),and/orRestrictiononHazardousSubstance(RoHS)Directive,contacttheRegulatoryAffairs DepartmentatInvivo:
4072753220 or 18003313220(tollfree) Internationally,pleasecontactyourKeyMarketrepresentative.Gotowww.invivocorp.comfora listing. Authorized Representative TheAuthorizedRepresentativefortheEuropeanUnion(asrequiredbytheMedicalDevice Directive,93/42/EEC)isasfollows:
PhilipsMedizinSystemeBblingenGmbH HewlettPackardStrae2 71034,Bblingen Germany Australia TheAustraliaSponsorisasfollows:
PhilipsElectronicsAustraliaLtd 65EppingRoad,NorthRydeNSW2113 Australia ExpressionMR200InstructionsforUseRegulatoryInformationC1 C2RegulatoryInformationExpressionMR200InstructionsforUse Guidelines and References APPENDIX D Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic Resonance Procedures Ingeneral,magneticresonance(MR)imagingisconsideredtobearelativelysafediagnostic modality.However,theuseofradiofrequencycoils,physiologicmonitors,electronically activateddevices,andexternalaccessoriesorobjectsmadefromconductivematerialshas causedexcessiveheating,resultinginburninjuriestopatientsundergoingMRprocedures. HeatingofimplantsandsimilardevicesmayalsooccurinassociationwithMRprocedures,but thistendsbeproblematicprimarilyforobjectsmadefromconductivematerialsthathave elongatedshapessuchasleads,guidewires,andcertaintypesofcatheters(e.g.,catheterswith thermistorsorotherconductingcomponents). Notably,morethan30incidentsofexcessiveheatinghavebeenreportedinpatientsundergoing MRproceduresintheUnitedStatesthatwereunrelatedtoequipmentproblemsorthepresence ofconductiveexternalorinternalimplantsormaterials[reviewofdatafilesfromU.S.Foodand DrugAdministration,CenterforDevicesandRadiologicalHealth,ManufacturerandUserFacility DeviceExperienceDatabase,MAUDE,http://www.fda.gov/cdrh/maude.htmlandU.S.Foodand DrugAdministration,CenterforDevicesandRadiologicalHealth,MedicalDeviceReport,(http://
www.fda.gov/CDRH/mdrfile.html)].Theseincidentsincludedfirst,second,andthirddegree burnsthatwereexperiencedbypatients.Inmanyofthesecases,thereportsindicatedthatthe limbsorotherbodypartsofthepatientswereindirectcontactwithbodyradiofrequency(RF) coilsorotherRFtransmitcoilsoftheMRsystemsortherewereskintoskincontactpoints suspectedtoberesponsiblefortheseinjuries. MRsystemsrequiretheuseofRFpulsestocreatetheMRsignal.ThisRFenergyistransmitted readilythroughfreespacefromthetransmitRFcoiltothepatient.Whenconductingmaterials areplacedwithintheRFfield,theresultmaybeaconcentrationofelectricalcurrentssufficient tocauseexcessiveheatingandtissuedamage.Thenatureofhighfrequencyelectromagnetic fieldsissuchthattheenergycanbetransmittedacrossopenspaceandthroughinsulators. Therefore,onlydeviceswithcarefullydesignedcurrentpathscanbemadesafeforuseduring MRprocedures.Simplyinsulatingconductivematerial(e.g.,wireorlead)orseparatingitfrom thepatientmaynotbesufficienttopreventexcessiveheatingorburnsfromoccurring. Furthermore,certaingeometricalshapesexhibitthephenomenonofresonancewhich increasestheirpropensitytoconcentrateRFcurrents.Attheoperatingfrequenciesofpresent dayMRsystems,conductingloopsoftensofcentimetersinsizemaycreateproblemsand, therefore,mustbeavoided,unlesshighimpedanceisusedtolimitRFcurrent.Importantly,even loopsthatincludesmallgapsseparatedbyinsulationmaystillconductcurrent. Topreventpatientsfromexperiencingexcessiveheatingandpossibleburnsinassociationwith MRprocedures,thefollowingguidelinesarerecommended:
ExpressionMR200InstructionsforUseGuidelinesandReferencesD1 1. PreparethepatientfortheMRprocedurebyensuringthattherearenounnecessary metallicobjectscontactingthepatient'sskin(e.g.,metallicdrugdeliverypatches,jewelry, necklaces,bracelets,keychains,etc.). 2. PreparethepatientfortheMRprocedurebyusinginsulationmaterial(i.e.,appropriate padding)topreventskintoskincontactpointsandtheformationofclosedloopsfrom touchingbodyparts. 3. Insulatingmaterial(minimumrecommendedthickness,1cm)shouldbeplacedbetween thepatient'sskinandtransmitRFcoilthatisusedfortheMRprocedure(alternatively,the RFcoilitselfshouldbepadded).Forexample,positionthepatientsothatthereisnodirect contactbetweenthepatient'sskinandthebodyRFcoiloftheMRsystem.Thismaybe accomplishedbyhavingthepatientplacehis/herarmsoverhis/herheadorbyusingelbow padsorfoampaddingbetweenthepatient'stissueandthebodyRFcoiloftheMRsystem. ThisisespeciallyimportantforthoseMRexaminationsthatusethebodycoilorotherlarge RFcoilsfortransmissionofRFenergy. 4. Useonlyelectricallyconductivedevices,equipment,accessories(e.g.,ECGleads, electrodes,etc.),andmaterialsthathavebeenthoroughlytestedanddeterminedtobe safeandcompatibleforMRprocedures,aslistedinthisIFU. 5. CarefullyfollowspecificMRsafetycriteriaandrecommendationsforimplantsmadefrom electricallyconductivematerials(e.g.,bonefusionstimulators,neurostimulationsystems, etc.). 6. Beforeusingelectricalequipment,checktheintegrityoftheinsulationand/orhousingof allcomponentsincludingsurfaceRFcoils,monitoringleads,cables,andwires.Preventive maintenanceshouldbepracticedroutinelyforsuchequipment. 7. RemoveallnonessentialelectricallyconductivematerialsfromtheMRsystem(i.e., unusedsurfaceRFcoils,ECGleads,cables,wires,etc.). 8. KeepelectricallyconductivematerialsthatmustremainintheMRsystemfromdirectly contactingthepatientbyplacingthermaland/orelectricalinsulationbetweenthe conductivematerialandthepatient. 9. KeepelectricallyconductivematerialsthatmustremainwithinthebodyRFcoilorother transmitRFcoiloftheMRsystemfromformingconductiveloops.Note:Thepatient's tissueisconductiveand,therefore,maybeinvolvedintheformationofaconductiveloop, whichcanbecircular,Ushaped,orSshaped. 10. Positionelectricallyconductivematerialstopreventcrosspoints.Forexample,across pointisthepointwhereacablecrossesanothercable,whereacableloopsacrossitself,or whereacabletoucheseitherthepatientorsidesofthetransmitRFcoilmorethanonce. Notably,eventhecloseproximityofconductivematerialswitheachothershouldbe avoidedbecausesomecablesandRFcoilscancapacitivelycouple(withoutanycontactor crossover)whenplacedclosetogether. 11. PositionelectricallyconductivematerialstoexitdownthecenteroftheMRsystem(i.e., notalongthesideoftheMRsystemorclosetothebodyRFcoilorothertransmitRFcoil). D2GuidelinesandReferencesExpressionMR200InstructionsforUse 12. Donotpositionelectricallyconductivematerialsacrossanexternalmetallicprosthesis
(e.g.,externalfixationdevice,cervicalfixationdevice,etc.)orsimilardevicethatisindirect contactwiththepatient. 13. Allowonlyproperlytrainedindividualstooperatedevices(e.g.,monitoringequipment)in theMRenvironment. 14. Followallmanufacturerinstructionsfortheproperoperationandmaintenanceof physiologicmonitoringorothersimilarelectronicequipmentintendedforuseduringMR procedures. 15. ElectricaldevicesthatdonotappeartobeoperatingproperlyduringtheMRprocedure shouldberemovedfromthepatientimmediately. 16. CloselymonitorthepatientduringtheMRprocedure.Ifthepatientreportssensationsof heatingorotherunusualsensation,discontinuetheMRprocedureimmediatelyand performathoroughassessmentofthesituation. 17. RFsurfacecoildecouplingfailurescancauselocalizedRFpowerdepositionlevelstoreach excessivelevels.TheMRsystemoperatorwillrecognizesuchafailureasasetofconcentric semicirclesinthetissueontheassociatedMRimageorasanunusualamountofimage nonuniformityrelatedtothepositionoftheRFcoil. Theadoptionoftheseguidelineswillhelptoensurethatpatientsafetyismaintained,especially asmoreconductivematerialsandelectronicallyactivateddevicesareusedinassociationwith MRprocedures. BasheinG,SyroryG.Burnsassociatedwithpulseoximetryduringmagneticresonanceimaging. Anesthesiology1991;75:3823. BrownTR,GoldsteinB,LittleJ.Severeburnsresultingfrommagneticresonanceimagingwith cardiopulmonarymonitoring.Risksandrelevantsafetyprecautions.AmJPhysMedRehabil 1993;72:1667. ChouCK,McDougallJA,ChanKW.Absenceofradiofrequencyheatingfromauditoryimplants duringmagneticresonanceimaging.Bioelectromagnetics1997;44:367372. DempseyMF,CondonB.ThermalinjuriesassociatedwithMRI.ClinRadiol2001;56:45765. DempseyMF,CondonB,HadleyDM.Investigationofthefactorsresponsibleforburnsduring MRI.JMagnResonImaging2001;13:627631. ECRI,HealthDevicesAlert.AnewMRIcomplication?HealthDevicesAlert.May27,pp.1,1988. ECRI.ThermalinjuriesandpatientmonitoringduringMRIstudies.HealthDevicesAlert.1991;20:
362363. References ExpressionMR200InstructionsforUseGuidelinesandReferencesD3 FinelliDA,RezaiAR,RuggieriPM,TkachJA,NyenhuisJA,HrdlickaG,SharanA,GonzalezMartinez J,StypulkowskiPH,ShellockFG.MRimagingrelatedheatingofdeepbrainstimulation electrodes:Invitrostudy.AmJNeuroradiol2002;23:17951802. HeinzW,FrohlichE,StorkT.Burnsfollowingmagneticresonancetomographystudy.(German)Z Gastroenterol1999;37:312. http://www.MRIsafety.com InternationalElectrotechnicalCommission(IEC),MedicalElectricalEquipment,Particular requirementsforthesafetyofmagneticresonanceequipmentformedicaldiagnosis, InternationalStandardIEC60601233,2002. JonesS,JaffeW,AlviR.Burnsassociatedwithelectrocardiographicmonitoringduringmagnetic resonanceimaging.Burns1996;22:4201. KanalE,ShellockFG.BurnsassociatedwithclinicalMRexaminations.Radiology1990;175:585. KanalE,ShellockFG.Policies,guidelines,andrecommendationsforMRimagingsafetyand patientmanagement.JMagnResonImaging1992;2:247248. KeensSJ,LaurenceAS.BurnscausedbyECGmonitoringduringMRIimaging.Anaesthesia 1996;51:11889. KnoppMV,EssigM,DebusJ,ZabelHJ,vanKaickG.Unusualburnsofthelowerextremities causedbyaclosedconductingloopinapatientatMRimaging.Radiology1996;200:5725. KnoppMV,MetznerR,BrixG,vanKaickG.Safetyconsiderationstoavoidcurrentinducedskin burnsinMRIprocedures.(German)Radiologe199838:75963. KugelH,BremerC,PuschelM,FischbachR,LenzenH,TombachB,VanAkenH,HeindelW. HazardoussituationintheMRbore:inductioninECGleadscausesfire.EurRadiol2003;13:690 694. NakamuraT,FukudaK,HayakawaK,AokiI,MatsumotoK,SekineT,UedaH,ShimizuY. Mechanismofburninjuryduringmagneticresonanceimaging(MRI)simpleloopscaninduce heatinjury.FrontMedBiolEng2001;11:11729 NyenhuisJA,KildishevAV,FosterKS,GraberG,AtheyW.Heatingnearimplantedmedicaldevices bytheMRIRFmagneticfield.IEEETransMagn1999;35:41334135. RezaiAR,FinelliD,NyenhuisJA,HrdlickG,TkachJ,RuggieriP,StypulkowskiPH,SharanA, ShellockFG.Neurostimulatorfordeepbrainstimulation:ExvivoevaluationofMRIrelated heatingat1.5Tesla.JournalofMagneticResonanceImaging2002;15:241250. SchaeferDJ.SafetyAspectsofradiofrequencypowerdepositioninmagneticresonance.MRI ClinicsofNorthAmerica1998;6:775789. SchaeferDJ,FelmleeJP.RadiofrequencysafetyinMRexaminations,SpecialCrossSpecialty CategoricalCourseinDiagnosticRadiology:PracticalMRSafetyConsiderationsforPhysicians, Physicists,andTechnologists,Syllabus,87thScientificoftheRadiologicalSocietyofNorth America,Chicago,pp111123,2001. ShellockFG.MagneticResonanceProcedures:HealthEffectsandSafety.CRCPress,LLC,Boca Raton,FL,2001. D4GuidelinesandReferencesExpressionMR200InstructionsforUse ShellockFG.MRsafetyupdate2002:Implantsanddevices.JournalofMagneticResonance Imaging2002;16:485496. ShellockFG.RadiofrequencyinducedheatingduringMRprocedures:Areview.Journalof MagneticResonanceImaging2000;12:3036. ShellockFG.ReferenceManualforMagneticResonanceSafety:2003Edition,Amirsys,Inc.,2003. ShellockFG,SlimpG.SevereburnofthefingercausedbyusingapulseoximeterduringMRI. AmericanJournalofRoentgenology1989;153:1105. ShellockFG,HatfieldM,SimonBJ,BlockS,WamboldtJ,StarewiczPM,PunchardWFB. Implantablespinalfusionstimulator:assessmentofMRIsafety.JournalofMagneticResonance Imaging2000;12:214223. SmithCD,NyenhuisJA,KildishevAV.Healtheffectsofinducedelectricalfields:implicationsfor metallicimplants.In:ShellockFG,ed.Magneticresonanceprocedure:healtheffectsandsafety. BocaRaton,FL:CRCPress,2001;393414. U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH),Medical DeviceReport(MDR)(http://www.fda.gov/CDRH/mdrfile.html).Thefilescontaininformation fromCDRH'sdeviceexperiencereportsondeviceswhichmayhavemalfunctionedorcauseda deathorseriousinjury.ThefilescontainreportsreceivedunderboththemandatoryMedical DeviceReportingProgram(MDR)from19841996,andthevoluntaryreportsuptoJune1993. Thedatabasecurrentlycontainsover600,000reports. U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH), ManufacturerandUserFacilityDeviceExperienceDatabase,MAUDE,(http://www.fda.gov/cdrh/
maude.html).MAUDEdatarepresentsreportsofadverseeventsinvolvingmedicaldevices.The dataconsistsofallvoluntaryreportssinceJune,1993,userfacilityreportssince1991,distributor reportssince1993,andmanufacturerreportssinceAugust,1996. ExpressionMR200InstructionsforUseGuidelinesandReferencesD5 D6GuidelinesandReferencesExpressionMR200InstructionsforUse Notes Notes Notes Notes Notes Notes Notes Notes
1 | LABEL LOCATION | ID Label/Location Info | 26.30 KiB |
Assembly Instruction, Wireless wECG Module, RoHS Philips Healthcare 4. Apply Overlays 1.0 MR200 989803183661 and 453564390601 For Expression 2.0 Remove paper backing, orient, and install 453564381661 Back Housing Label within the ridges of the Back Housing. End Expression 3.0 End Assembly Process 4.0 Perform full final functional and RF Tests of unit per A-989803163121-90001 (Wireless wECG 2nd Gen Module Functional Test Procedure) and package for shipping or stocking to finished goods Rev. A.2 Document Number A-989803183661-90001 Title: Assembly Instruction, Wireless wECG Module, RoHS Page 19 of 26 Restricted
1 | LABEL SAMPLE | ID Label/Location Info | 123.30 KiB |
50.72
[1.997]
Assembled for Invivo, a division of Philips Medical Systems 12151 Research Parkway, Orlando, FL 32826 USA Made in USA KCC-CRI-PCE-WirelessECG 0413 0979 REF 989803183661 (ECG) FCC ID: S6W2GMODSB IC: 6331A-2GMODSB R 201 WW 08215384 Color Key Chart White Pantone Black C NOTES:
1. Dimensions are in millimeters [inches]. 2. Text/graphics colors: White. 3. Background color: Pantone Black C. 4. Refer to mechanical file 453564381661for additional requirements. Artwork is incomplete without mechanical file. Scale: 1:1 RoHS COMPLIANT Note:
This document is confidential and proprietary and is the sole property of Invivo Corporation. It is not to be disclosed to any party, reproduced or used in any other manner without the written consent or said company. Invivo Corporation maintains the right to change specifications at any time without prior notice. Drawn:
DGK Date:
13NOV13 EC No. SEE eDMR ORLANDO, FLORIDA 32826 Title:
ARTWORK;
Label, Back Housing, wECG, ROHS Sht of 1 1 Dwg No. 453564381661-M-MART Rev:
D Assembled for Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826 USA XXXX-XX Expression Patient Monitor Model MR200 REF SN 000000000000 0000000000 0413 0979 Rx Only Made in USA Mass: 36.6 kg IPX1 This device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation. IC: 4492A-2410NF IC: 6331A-DR3160 CCAI10LP1540T6 FCC ID: S6WDR3160BAS HSW-2410NF Cirronet 0889 EC REP Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Str.2 71034 Bblingen, Germany SERVICE #
SN 000000000000 0000000000 NOTES:
1. Dimensions are in millimeters [inches]. 2. Text/graphics colors: Black. 3. Background color: White. 4. Blue perimeter outline represents die-cut and does not print. 5. Refer to mechanical file 453564357841 for additional requirements. Artwork is incomplete without mechanical file. Scale: 1:1 Note:
This document is confidential and proprietary and is the sole property of Invivo Corporation. It is not to be disclosed to any party, reproduced or used in any other manner without the written consent or said company. Invivo Corporation maintains the right to change specifications at any time without prior notice. Title:
ORLANDO, FLORIDA 32826 LABEL, MODEL/SERIAL, REG/SER Drawn:
DGK Date:
08NOV13 EC No. SEE eDMR Sht of 1 1 Dwg No. 453564357841-M-MART Rev:
F
1 | CONFIDENTIAL LETTER | Cover Letter(s) | 349.71 KiB |
Invive PHILIPS November 14, 2013 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: (place FCC ID here). Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:
Exhibit Type File Name Block Diagram Block Diagram.pdf Schematic Schematics .pdf Circuit description Circuit Description.pdf The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Pursuant to DA04-1705 Sune 15, 2004 of ihe Commissions public notice, we also request temporary confidential treatment of information accompanying this application as outlined below:
Exhibit Type File Name Users Manual Users Manual WECG Module. pdf External Photos External Photo WECG Module_back.jpg External Photo WECG Module_front jpg Internal Photos Internal_photo_AB239_sidel.jpg Internal_photo_AB239 side2.jpg Internal_photo_wecg 2gsb_sidel.jpg Internal photo _wecg 2gsb_side2.jpg Sincerely, KouoptaS Match iA Krystal Mitchell Quality & Regulatory Engineer Invivo Corporation
frequency | equipment class | purpose | ||
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1 | 2013-11-22 | 2402 ~ 2482 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2013-11-22
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1 | Applicant's complete, legal business name |
Invivo Corporation
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1 | FCC Registration Number (FRN) |
0011288180
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1 | Physical Address |
12151 Research Parkway, Suite 200
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1 |
Orlando
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1 |
United States
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app s | TCB Information | |||||
1 | TCB Application Email Address |
T******@TIMCOENGR.COM
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1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 | Grantee Code |
S6W
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1 | Equipment Product Code |
2GMODSB
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K****** M****
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1 | Title |
Quality & Regulatory Engineer
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1 | Telephone Number |
407-2******** Extension:
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1 | Fax Number |
407-2********
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1 |
k******@philips.com
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app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 05/21/2014 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | WIRELESS ECG MODULE | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Limited Single Modular Approval | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Timco Engineering, Inc.
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1 | Name |
B**** C******
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1 | Telephone Number |
352-4********
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1 | Fax Number |
352 4********
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1 |
b******@timcoengr.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2482.00000000 | 0.0010000 | 30.0000000000 ppm |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC