MR400 Patient Monitoring Device for MRI Environments Manual

 

Expression MR400 MRI Patient Monitoring System INSTRUCTIONS FOR USE Revision A English

*989803193211*

989803193211 Manufacturer Invivo,adivisionofPhilipsMedicalSystems 12151ResearchParkway Orlando,FL32826,USA 8774684861 Email:

Info@invivocorp.com Websites:

www.ExpressionMR.com www.invivocorp.com www.philips.com Identification and Publication Details PublishedbyInvivo,adivisionofPhilipsMedicalSystems. Invivo,adivisionofPhilipsMedicalSystems,reservestherighttomakechangestoboththis InstructionsforUseandtotheproductitdescribes.Productspecificationsaresubjecttochange withoutnotice.NothingcontainedwithinthisInstructionsforUseisintendedasanyoffer, warranty,promiseorcontractualcondition,andmustnotbetakenassuch. KoninklijkePhilipsN.V.(RoyalPhilips)2015 Allrightsreserved.Reproductioninwholeorinpartinanyformorbyanymeans,electrical, mechanicalorotherwiseisprohibitedwithoutthewrittenconsentofthecopyrightholder. REF989803193211Rev.A,March2015 Invivo,adivisionofPhilipsMedicalSystems 12151ResearchParkway Orlando,FL32826 USA Unauthorizedcopyingofthispublicationmaynotonlyinfringecopyright,butalsoreducethe abilityofPhilipsMedicalSystemstoprovideaccurateanduptodateinformationtousers. PublishedinUSA ii Regulatory Compliance TheExpressionMR400MRIPatientMonitoringSystemcomplieswithrelevantinternationaland nationalstandardsandlaws.Informationoncompliancewillbesuppliedonrequestbyyourlocal RoyalPhilipsrepresentative,orbythemanufacturer. Explanation of Symbols ThesymbolsinthefollowingtablemayappearontheExpressionMR400MRIPatientMonitoring System,theaccessories,orthepackingmaterial. Symbol Symbol Underwriters Laboratories Component Recognition Mark for both the U.S. and Canadian markets Ministry of Internal Affairs and Communications Japanese Radio Law Certification Korean Communications Commission radio certification Conforms to the European Medical Devices Directive Authorized representative in the European Community Catalog, reorder or reference part number Federal Communications Commission radio certification UL has determined that the product meets requirements Taiwan National Communications Commission certification Conforms to the R&TTE Directive (Radio &

Telecommunications Terminal Equipment) Serial number Batch code / lot number iii Symbol Symbol Sterilized using radiation Unique device identifier Sterilized using ethylene oxide MR Conditional: Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety. MR safe: Completely safe for use with no potential for interaction with the MR field. Consult the Instructions for Use The Instructions for Use must be consulted Do not adjust without referring to the service manual Do not use if container is damaged In vitro diagnostics compliant MR unsafe: Must not be used in an MRI environment Warning! Specific warnings associated with the devices that are not otherwise found on the label; and, on the connector of the wireless ECG patient module, this indicates that only specified ECG lead cables shall be used to ensure safe use in the MR and defibrillation protection. Caution! See Instructions for Use for specific warnings or precautions associated with the devices that are not otherwise found on the label Separate to open then insert Single use only, disposable one-time-use product; do not reuse Defibrillator-proof type CF equipment (IEC 60601-

1) protection against shock iv Symbol YYYY-MM-DD YYYY-MM Use by date; do not use after the year (YYYY), month (MM) and day

(DD) indicated Use by date; do not use after the year (YYYY), month (MM) Do not push Alternating current SPO2 probe quantity equals Adult SPO2 clip quantity equals Infant SPO2 grip quantity equals Adult SPO2 grip quantity equals Infant Toe site Finger site Symbol Cable tag marked with use by date; do not use after the year (YYYY) and month (MM) indicated AC receptacle, below Correct Not sterile Direct current Pediatric SPO2 clip quantity equals Neonatal SPO2 grip quantity equals Pediatric SPO2 grip quantity equals Neonate Thumb site Big toe site v Symbol Symbol Prescription only Foot site NIBP cuff, correct side out Temperature range Non-pyrogenic fluid path NIBP cuff, wrong side out Airway adapter quantity equals NIBP cuff circumference range Anesthetic oxygen (O2) sensor location and part number IBP transducer cable quantity equals Weight Cannula quantity equals Humidity range For indoor use only Humidity range, non condensing Equipotential (earth) ground Fragile Keep dry vi Symbol Symbol Keep away from heat Atmospheric pressure limitation Packages per box Up Quantity equals Not manufactured with natural latex rubber Contains or presence of phthalate: bis (2-

ethylhexyl) phthalate Non-invasive blood pressure (NIBP) connection Quadtrode electrode Quadtrode electrode per package Non-ionizing radiation ECG AAMI ECG CV lead cable connections AAMI ECG lead cable connections AAMI ECG NEO lead cable connections IEC ECG CV lead cable connections IEC ECG lead cable connections IEC ECG NEO lead cable connections vii Symbol Symbol Cardiac gating output Universal Serial Bus (USB) Conforms to the RoHS directive Center positive connection: Positive (+) center pin, negative (-) outer ring Not for general waste Pneumatic respiration connection Gas input indicator Gas output indicator Electrical input indicator Electrical output indicator Temperature connection Manufacturer name and address Electrostatic discharge

(ESD) warning Date of manufacture

(year-month) YYYY-MM Non-magnetic part Battery Main battery (left side) Main battery (right side) viii Symbol Symbol Do not move the Expression MR400 MRI Patient Monitoring System inside the 5000 gauss field line of the MR magnet or up to the face of a 3T magnet, whichever is greater, as measured from the center line of the bore. Charge indicator, cart battery Power level button, cart battery Setup key Zero All key Clear Trends key NIBP Interval key 1-Touch Alarms key Apply wheel locks and do not move the Expression MR400 MRI Patient Monitoring System inside the 5000 gauss field line of the MR magnet or up to the face of a 3T magnet, whichever is greater, as measured from the center line of the bore. Wheel lock MRI compatible, up to 2500 gauss Main Screen key Print key, printer ready indication Print key, printing in process (and time remaining) indication Print key, no printer available indication Print key, printer error indication Suspend key Trends key NIBP Start/Stop key ECG Filter key Connected to AC mains Audio Pause key Alarm audio armed Alarm key ix Symbol Symbol Alarm audio paused Alarm audio off Power switch (Standby switch) Module battery adequate charge indication Module battery low charge indication Battery 2 indicator, wireless ECG patient module, After opening, allow at least 1 hour to pass before use Current setups have changed Heartbeat detected Breathing effort detected Battery 1 indicator, wireless ECG patient module, Battery indicator, wireless SpO2 patient module No communication IP5 connected Network channel 1 Network channel 6 Network channel 2 Network channel 7 Network channel 3 Network channel 8 Network channel 4 Network channel 9 x Symbol Symbol Network channel 5 Network channel 10 Ten FlexTEMP System Jackets per box Conventions CertainconventionsareusedthroughouttheExpressionMR400MRIPatientMonitoringSystem tospeeduseandfamiliaritywiththedevice.Thisaccompanyinguserinformationalsouses documentconventionstoassistyouinfindingandunderstandinginformation. System Conventions Thefollowingsystemconventionsareused:

Operationalcontrolisaccomplishedusingthetouchscreen,whereactiveelementsare providedandtouchingthatelementwillactivate,openorexecutetherelatedmenu, functionoritem. Mostmenusemployatimeoutfeaturewhere,ifnoactionistakenforapproximately30 60seconds,anopenmenuwillautomaticallyclose. Toprotectagainstaccidentalchanges,adialogpromptisassociatedwithsomemenu options.Whendisplayed,youmustanswerthisprompt;otherwise,adelayof approximately3060secondswillbeequivalenttoselectingNo(thiscanalsobe accomplishedbypressingtheMainScreenkey.) Toprotectagainstunauthorizedchanges,somemenuitemsfeaturepasswordprotection. Youmustenterthecorrectnumericcodeforaccessandadelayofapproximately3060 secondsisequivalenttomakingnoentry. Document Conventions Thesedocumentconventionsareused:

xi Allproceduresarenumberedandanysubstepsarelettered.Completethestepsinthe sequencepresentedtoensuresuccess.Proceduresareindicatedbythefollowingtable:

Step Action 1 2 3 Unlessnoted,allproceduresstartfromthenormalmodeofoperation. SelectmeanstopressonanactiveelementonthetouchscreenLCD(menuorsubmenu item,button,key,vitalsignbox,etcetera). Bulletedlistsindicategeneralinformationaboutaparticularfeature,menufunctionor procedure,anddonotimplysequentialorderoroperation. Controlnames,menuitems,vitalsignreferences,messages,etcetera,arespelledasthey appearontheExpressionMR400MRIPatientMonitoringSystem. Menuitems,keynamesandmessagesareprovidedinboldfont. Thegreaterthan(>)symbolisusedwhennavigationofitemswithinamenuisindicated. ThefrontoftheExpressionMR400MRIPatientMonitoringSystemisnearestyouasyou operateit;theleftandrightsidesarerespectivelytoyourleftandrightasyoustandin frontofthesystem,facingit. Thefrontofawirelessmoduleisnearestyouasyouoperateit.Thetopofthedevice pointsuporawaywhenthelabelingnearestyouduringoperationiscorrectlyorientedfor reading,whiletheleftandrightsidesofthedevicearerespectivelytoyourleftandrightas youholdthedeviceforoperation,facingit. xii Contents Manufacturer . 1-ii Identification and Publication Details. 1-ii Regulatory . 1-iii Explanation of Symbols . 1-iii Conventions . 1-xi System Conventions. 1-xi Document Conventions . 1-xi Chapter 1: Important Information About . 1-1 Intended Use . 1-2 Compatibility. 1-2 Indications for Use . 1-3 Contra-indications . 1-3 Training . 1-4 Safety. 1-4 Equipment Classification (According to IEC 60601-1) . 1-7 Electromagnetic Compatibility (EMC) . 1-8 Radios . 1-8 Using Batteries Safely . 1-12 Examining the Shipment . 1-13 Disposing of the Packaging . 1-14 Initial Setup . 1-14 Installing and Connecting Cart Batteries . 1-16 Attaching the SpO2 Probe to the wSpO2 Module . 1-18 Rear Panel Connections . 1-19 Connecting AC Mains Power . 1-20 Understanding Battery Operations. 1-21 Cart Batteries . 1-21 Charging Cart Batteries . 1-21 Removing Cart Batteries . 1-22 Wireless Module Batteries . 1-23 Charging Module Batteries . 1-24 Installing Batteries in the wECG Module . 1-24 Removing Batteries from the wECG Module. 1-25 Installing a Battery in the wSpO2 Module . 1-26 Removing the Battery from the wSpO2 Module . 1-27 Understanding Wireless Network Operations . 1-27 Setting the Wireless Network Channel of the Cart . 1-27 Setting the Wireless Network Channel of the wECG and wSpO2 Modules . 1-29 Advanced User Options . 1-33 Expression Information Portal (Model IP5). 1-33 Additional Options . 1-33 Accessory List . 1-33 Chapter 2: System Overview System Parameters . 2-1 Contents 1 System Components . 2-2 Use Model. 2-2 Acquisition and Control . 2-3 Synchronization . 2-3 Device Control . 2-4 Hardware Features . 2-5 Cart . 2-5 Display Panel . 2-6 Patient Connection Panel . 2-7 wECG and wSpO2 Modules . 2-8 wECG Module. 2-9 wECG Module Indicators . 2-9 wSpO2 Module . 2-11 wSpO2 Module Indicators . 2-11 Storing Modules and Accessories . 2-12 Displayed Information and Controls. 2-13 Information Bar . 2-14 Soft Keypad . 2-15 Status Information Pane . 2-16 Status Information Panel . 2-18 Vital Sign Boxes . 2-19 No Data Indications . 2-20 Other Data Indications . 2-21 Vital Sign Traces and System Message Area. 2-21 Navigation and Operation . 2-22 Specialized Control Buttons and Keys . 2-22 Default Setting Indications . 2-23 System Messages. 2-23 Password Protection. 2-23 Modes of Operation . 2-23 Normal Mode . 2-23 Suspend Mode . 2-24 Simulation Mode . 2-24 Chapter 3: Getting Started Defibrillator and Electrosurgical Use . 3-1 Positioning the MR400. 3-2 Operating the MR400. 3-3 System Power-up and Communications Verification . 3-4 Cart Power-down . 3-6 Wireless Module Power-down . 3-6 Monitor Initialization . 3-6 Viewing the Displayed Information. 3-7 Default Settings . 3-7 Default Setting Indications . 3-7 User Settings . 3-8 Initial Alarm Indications . 3-10 Selecting the Patient Type. 3-11 Setup Menus . 3-13 2 Contents Monitor Setup Menu . 3-14 Edit User Settings . 3-15 Parameters . 3-18 Sound Adjust . 3-20 Set Time & Date . 3-22 Sweep Speed . 3-25 Resp Speed. 3-25 Service(Bio-Med). 3-26 Revision Information . 3-28 Simulation Mode . 3-29 Gas Cal . 3-30 System Config . 3-30 ECG Tests . 3-32 NIBP Tests. 3-33 Backlight Brightness . 3-34 Service Utilities . 3-35 Chapter 4: Alarms Alarm Safety Information . 4-2 Visual Alarm Indications. 4-2 Alarm Flags . 4-2 Flashing Numeric . 4-3 Alarm Light . 4-3 Audible Alarm Indications. 4-4 Alarm Sound State Indication. 4-4 Initial Audible Alarm Setting Indications . 4-5 Controlling the Alarm Audio and Light Indications . 4-5 Audio Pause Mode . 4-6 Audio Off Mode . 4-6 Alarm Volume. 4-7 Alarm Reset . 4-7 Managing Alarm Functions . 4-8 Showing or Hiding Current Alarm Limits. 4-8 Adjusting the Alarm Limits . 4-9 Alarm Limit Controls . 4-9 The Alarm Window . 4-11 Advanced Alarm Functions . 4-11 Setting Alarm Limits Globally. 4-12 Setting Alarm Limits Individually . 4-13 Restoring Alarm Limit Defaults . 4-16 Enabling Print on Alarm . 4-17 Alarms Menu . 4-17 1-Touch High %. 4-18 1-Touch Low % . 4-19 Alarm Sound . 4-20 Alarm Light. 4-20 Default Limits. 4-21 Limits Display. 4-21 Adjustable Alarm Limit Ranges . 4-22 Contents 3 Alarm Limit Factory Defaults . 4-24 Measurement Limits and Over / Under Values . 4-25 Listing of Alarms . 4-26 Patient and INOP Alarms . 4-27 Technical (INOP) Alarms and Other Status Flags . 4-31 ECG . 4-31 SPO2 . 4-32 CO2 / CO (RESP) / AGENT. 4-33 P1 (or P2). 4-35 TEMP . 4-36 NIBP. 4-36 Other Status Indications. 4-37 Chapter 5: Monitoring ECG ECG Monitoring Considerations for the MR Environment . 5-1 wECG Module and ECG Lead Cable. 5-2 Quadtrode Electrodes . 5-3 Work Flow for ECG Monitoring . 5-3 Selecting the ECG Lead Cable and Quadtrode Electrode Type. 5-5 Identifying the Placement Site for the Quadtrode Electrode. 5-7 Preparing the Quadtrode Electrode Site. 5-11 Attaching the ECG Lead Cable. 5-12 Lead Fail Indication . 5-15 Checking the ECG Signal Strength. 5-16 Selecting the Scale . 5-16 Changing the Lead View . 5-17 Minimizing ECG Waveform Noise. 5-18 Positioning the ECG Lead Cable and wECG Module for Scanning . 5-19 Selecting the Filter Mode . 5-22 ECG Waveforms and VS Box . 5-22 Changing the Heart Rate Alarm Limits . 5-24 ECG Menu . 5-26 Trace A Lead . 5-27 Trace B Lead . 5-28 Scale . 5-28 Gating Source . 5-29 HR Source . 5-29 HR Tone Source . 5-30 Filter Mode . 5-31 Extreme HR . 5-32 Pediatric ECG . 5-32 T-Wave Suppression . 5-33 Chapter 6: Monitoring SPO2 wSpO2 Module, SpO2 Probe and SpO2 Attachment . 6-1 Patient Preparation for SpO2 Monitoring. 6-2 Selecting the Site and SpO2 Attachment . 6-2 Attaching the Clip or Grip to the SpO2 Probe . 6-3 4 Contents Applying the SpO2 Attachment to the Patient . 6-3 Perfusion Index Value . 6-6 Positioning the wSpO2 Module for Scanning . 6-6 SPO2 Waveform and VS Box . 6-8 Assessing Suspicious SPO2 Readings . 6-9 Changing the SPO2 Waveform Amplitude . 6-10 Changing the SPO2 Alarm Limits. 6-11 SPO2 Menu . 6-12 Size . 6-13 Averaging Time . 6-14 Perfusion Index . 6-15 Gating Source . 6-15 Desat . 6-15 Desat Time . 6-16 HR Source . 6-17 HR Tone Source . 6-18 Chapter 7: Monitoring CO2 (LoFlo Option) MR400 Preparation for CO2 Monitoring. 7-1 Operation and Use. 7-2 Warm-Up Period. 7-2 Zero Reference Adjustment . 7-2 Breath Rate Distortion . 7-3 Patient Preparation for CO2 Monitoring. 7-4 Selecting the CO2 Accessory. 7-4 Connecting the Sampling Line . 7-4 Applying the Sampling Line to the Patient . 7-6 CO2 Waveform and VS Box . 7-7 Changing the CO2 and CO2 (RESP) Alarm Limits . 7-9 Changing the Unit of Measure . 7-11 CO2 Menu . 7-12 Size . 7-13 Grids . 7-14 Zero Cal. 7-15 Chapter 8: Monitoring Invasive Blood Pressure Indications and Contraindications . 8-1 Adult and Pediatric Patients . 8-1 Neonatal Patients . 8-1 Patient Preparation for IBP Monitoring. 8-2 Transducer Component, Connection, and Feature Locations . 8-2 MR 400 Preparation for IBP Monitoring . 8-3 Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631) . 8-4 I. Connecting the Reusable Cable to the MR400 . 8-4 II. Kit Set Up. 8-5 III. Purging Air from the Monitoring Line . 8-6 IV. Zeroing, Leveling and Calibration. 8-7 V. Connecting the Monitoring Kit to the Patient. 8-8 Contents 5 The IBP transducer must not be mounted to the patient, or patient burn may result. 8-8 VI. Fast Flushing . 8-9 VII. Checking for Leaks . 8-9 VIII. In the MR Room . 8-9 Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641). 8-10 I. Connecting the Reusable Cable to the MR400. 8-10 II. Kit Set Up. 8-10 III. Purging Air from the Monitoring Line. 8-12 IV. Zeroing, Leveling and Calibration. 8-12 V. Connecting the Monitoring Kit to the Patient . 8-14 VI. Checking for Leaks. 8-15 VII. In the MR Room. 8-15 Zeroing the Pressure Transducer . 8-16 Systolic/Diastolic Format. 8-17 Mean Format. 8-18 Changing the P1 (or P2) Format. 8-19 Changing the P1 (or P2) Waveform Amplitude. 8-19 Changing the P1 (or P2) Alarm Limits . 8-20 Changing the Unit of Measure . 8-22 P1 (and P2) Menu . 8-22 Zero Set . 8-24 Set Label . 8-24 Size . 8-25 HR Source . 8-26 Grids. 8-26 Grids Size. 8-27 Format . 8-28 Chapter 9: Monitoring Agents and Gases (AGENT Option) MR400 Preparation for AGENT Monitoring . 9-1 Operation and Use. 9-1 Warm-Up Period . 9-2 Zero Reference Adjustment . 9-2 Breath Rate Distortion. 9-3 CO2 Low Flow and Occlusion Conditions . 9-4 Selecting AGENT Accessories . 9-5 AGENT Tubing Preparation. 9-5 Pre-Use System Checks. 9-8 Applying the Sampling Line to the Patient . 9-10 Water Trap Replacement. 9-13 AGENT and GAS VS Boxes . 9-14 Multiple (Mixed) Agents . 9-15 AGENT VS Box. 9-16 GAS VS Box . 9-17 Changing the AGENT and GAS Alarm Limits. 9-17 MAC Window . 9-20 CO2 Waveform and VS Box . 9-22 Changing the CO2 and CO2 (RESP) Alarm Limits. 9-23 Changing the Unit of Measure . 9-26 6 Contents CO2 Menu . 9-27 Size . 9-28 Grids . 9-29 Zero Cal. 9-30 Chapter 10: Monitoring RESP Patient Preparation for RESP Monitoring. 10-1 Monitoring Respiration using CO2 . 10-1 Monitoring Respiration using the Bellows. 10-1 Bellows Preparation . 10-2 Respiration VS Box . 10-3 Changing the CO2 (RESP) Alarm Limits . 10-5 RESP Menu . 10-5 Source . 10-7 Apnea . 10-8 Apnea Time . 10-8 Chapter 11: Monitoring Temperature General Usage Precautions. 11-1 Initial Use . 11-2 Connecting and Disconnecting the Sensor . 11-3 Temperature Measurements . 11-4 Making Surface Temperature Measurements . 11-4 Making Body Temperature Measurements . 11-5 Placing the Temperature Sensor in a Jacket. 11-5 Placing the Temperature Sensor at the Body Site. 11-6 Post-Measurement Processing . 11-7 Accuracy Check . 11-8 TEMP VS Box . 11-8 Changing the TEMP Alarm Limits . 11-9 Changing the Unit of Measure . 11-10 TEMP Menu . 11-10 Units. 11-11 Chapter 12: Monitoring NIBP Patient Preparation for NIBP Monitoring . 12-2 Selecting the NIBP Cuff . 12-3 Positioning the NIBP Cuff. 12-5 Connecting the NIBP Cuff . 12-5 Choosing the Measurement Mode . 12-6 Making Automatic Measurements . 12-6 Making Manual Measurements . 12-7 Initial Inflation Pressures and Reading Durations. 12-7 Stopping an NIBP Measurement . 12-8 Suspend Mode during NIBP Measurements . 12-8 NIBP VS Box . 12-8 Systolic/Diastolic Format . 12-8 Contents 7 Mean Format. 12-10 Changing the NIBP Format. 12-11 Changing the Unit of Measure . 12-11 Changing the NIBP Alarm Limits . 12-12 NIBP Menu. 12-14 Interval . 12-15 Auto Mode . 12-16 Format . 12-17 Chapter 1:3 Trend Data and Printing Trending Functions . 13-1 Viewing Tabular Trend Data . 13-1 Tabular Trends Menu . 13-1 Trend Arrows . 13-4 Arrow Period . 13-6 Data Interval. 13-7 Clear Trends . 13-8 Print Page . 13-9 Print All. 13-9 Stop Print . 13-9 Printing Functions . 13-10 Printing Parameter-Specific Trends . 13-10 Controlling Printer Outputs . 13-10 Printer Indications . 13-11 Printer Menu . 13-11 Trace 1. 13-13 Trace 2. 13-14 Trace Delay . 13-15 Chapter 14: Maintenance and Troubleshooting General Cleaning Guidelines. 14-1 Removing all Power to the MR400 . 14-2 Restoring all Power to the MR400 . 14-4 Removing Power from the Wireless Modules . 14-4 Restoring Power to the Wireless Modules . 14-4 User Routine-Checks and Planned Maintenance . 14-4 Cleaning, Disinfection, and Damage Inspection . 14-6 Cleaning, Disinfecting, and Inspecting the Accessories. 14-7 Cleaning, Disinfecting, and Inspecting MR400 and Wireless Modules . 14-9 Sterilization . 14-10 Testing Alarms. 14-11 Testing a Dropped Wireless Module . 14-12 Verification Testing . 14-13 Anesthetic Oxygen (O2) Sensor Depletion . 14-13 Replacing the O2 Sensor . 14-13 Updating Software . 14-15 Calibrating the Touch Screen . 14-16 Troubleshooting . 14-16 8 Contents Repair . 14-16 Environmental Requirements . 14-17 Passing the Product on to another User . 14-18 Packaging the MR400. 14-18 Final Disposal of the Product . 14-21 Disposal of the MR400 and Accessories. 14-21 Fitting, Removing and Disposing of Batteries . 14-22 Appendix A: Specifications General . A-1 Displayed Information . A-6 ECG. A-7 Pulse Oximeter . A-9 CO2 (Optional LoFlo) . A-10 Invasive Blood Pressure (Optional). A-13 AGENT (Optional) . A-15 Bellows Respiration. A-23 Temperature (Optional). A-23 Non-Invasive Blood Pressure . A-24 Gating Outputs . A-28 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: Gating Feature MR400 Preparation for Gating . D-1 Gating Connector Pin-outs . D-1 Using the Gating Feature . D-2 Using ECG Gating. D-2 Using SPO2 Gating. D-4 Appendix E: Guidelines and References Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic Resonance Procedures. E-1 References . E-3 Contents 9 10 Contents About CHAPTER 1 Important Information AbouttheExpressionMR400MRIPatientMonitoringSystemandthisInstructionsforUse ThisInstructionsforUseisintendedtoassistusersinthesafeandeffectiveoperationofthe ExpressionMR400MRIPatientMonitoringSystem. Beforeattemptingtooperatetheproduct,youmustreadthisInstructionsforUse,notingand strictlyobservingallWARNINGSandCAUTIONnotices. PayspecialattentiontoalltheinformationgivenandproceduresdescribedintheSAFETY section. AWARNINGalertsyoutoapotentialseriousoutcome,adverseeventorsafetyhazard.Failureto observeawarningmayresultindeathorseriousinjurytotheuserorpatient. ACAUTIONalertsyoutowherespecialcareisnecessaryforthesafeandeffectiveuseofthe product.Failuretoobserveacautionmayresultinminorormoderatepersonalinjuryordamage totheproductorotherproperty,andpossiblyinaremoteriskofmoreseriousinjury,and/or causeenvironmentalpollution. ANotehighlightsanunusualpointasanaidtoauser. ThisInstructionsforUsedescribesthemostextensiveconfigurationoftheproduct,withthe maximumnumberofoptionsandaccessories.Noteveryfunctiondescribedmaybeavailableon yourproduct. Thisproductwillperforminconformitywiththedescriptioncontainedinthismanualand accompanyinglabelingwhenoperated,maintainedandrepairedinaccordancewiththe instructionsprovided. Thisdevicemustbecheckedandcalibratedperiodically.Amalfunctioningdevicemustnotbe used.Partsthatarebroken,missing,plainlyworn,distorted,orcontaminatedmustbereplaced immediately.Referthedevicetoqualifiedservicepersonnelforrepairorreplacement.This deviceoranyofitspartsmustnotberepairedotherthaninaccordancewithwritteninstructions providedbythemanufacturer.ThedeviceshallnotbealteredwithoutwrittenapprovalofRoyal Philips.Theuserhasthesoleresponsibilityforanymalfunctionwhichresultsfromimproperuse, faultymaintenance,improperrepair,damageoralterationbyanyoneotherthanauthorized servicepersonnel. ExpressionMR400InstructionsforUseImportantInformation11 Intended Use ThisPhilipsproductisintendedtobeusedandoperatedonlyinaccordancewiththesafety proceduresandoperatinginstructionsgiveninthisInstructionsforUseforthepurposesfor whichitwasdesigned.Thepurposesforwhichtheproductisintendedisgivenbelow.However, nothingstatedinthisInstructionsforUsereducesusersresponsibilitiesforsoundclinical judgmentandbestclinicalprocedure. TheExpressionMR400MRIPatientMonitoringSystemisintendedforusebyhealthcare professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals forthesynchronizationoftheMRIscanner. Useandoperationofthisproductissubjecttothelawinthejurisdiction(s)inwhichtheproduct isbeingused.Usersmustonlyinstall,useandoperatetheproductinsuchwaysasdonotconflict withapplicablelaws,orregulations,whichhavetheforceoflaw.Usesoftheproductfor purposesotherthanthoseintendedandexpresslystatedbythemanufacturer,aswellas incorrectuseoroperation,mayrelievethemanufacturer(orhisagent)fromallorsome responsibilityforresultantnoncompliance,damageorinjury. CAUTION Federal law restricts this device to sale by or on the order of a physician. Compatibility Theproductdescribedinthismanualshouldnotbeusedincombinationwithotherproductsor componentsunlesssuchotherproductsorcomponentsareexpresslyrecognizedascompatible byPhilipsMedicalSystems.[Alistofsuchproductsandcomponentsisavailablefromthe manufacturer].Changesand/oradditionstotheproductshouldonlybecarriedoutbyPhilips MedicalSystemsorbythirdpartiesexpresslyauthorizedbyPhilipsMedicalSystemstodoso. Suchchangesand/oradditionsmustcomplywithallapplicablelawsandregulationsthathave theforceoflawwithinthejurisdiction(s)concerned,andwithbestengineeringpractice. Warning WARNING Changes and/or additions to the product that are carried out by persons without the appropriate training and/or using unapproved spare parts may lead to the PMS warranty being voided. As with all complex technical products, maintenance by persons not appropriately qualified and/or using unapproved spare parts carries serious risks of damage to the product and of personal injury. 12ImportantInformationExpressionMR400InstructionsforUse Indications for Use TheExpressionMR400MRIPatientMonitoringSystemisintendedforusebyhealthcare professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals forsynchronizationfortheMRIscanner(alsoreferredtoastriggeringorgating). The ExpressionMR400providesmonitoringforthefollowingvitalsignsandparameters:

electrocardiogram(ECG),pulseoximetry(SpO2),noninvasivebloodpressure(NIBP);and optionally,invasivebloodpressure(IBP),carbondioxide(CO2)andrespirationrate,anesthetic agents,oxygen(O2),nitrousoxide(N2O),andtemperature. Notes The MR400 is intended to be used to monitor the vital signs of a patient in an MR magnet room. Monitoring outside the magnet room (e.g., the MR induction and/or MR recovery areas) is acceptable for the short duration of time in which the patient is being prepared for the MR scan and during the recovery period within the MR. This system is not intended for use on a patient being transported outside of a health care facility. The MR400 is intended for use on patients receiving MR scans, which may include neonatal, pediatric, or adult patients. If determined by a qualified healthcare provider, this may also include pregnant patients. The bellows-derived respiration rate measurement is not intended for vital sign monitoring. Contra-indications ThisPhilipsproductshouldnotbeusedifanyofthefollowingcontraindicationsexistorare thoughttoexist.Thisdeviceiscontraindicatedforpatientswithmetallicwires,implants,stents, etcetera.Screenallpatientsformetallicwires,implants,stents,etceterapriortoMR procedures.TheseelectricalconductorswillreactwiththeMRenvironmentorwiththe accessory(ifapplieddirectlyovertheconductor),thusincreasingtheriskofheating.The warningsbelowrefertotheExpressionMR400MRIPatientMonitoringSysteminitsentirety. WARNINGS The Expression MR400 MRI Patient Monitoring System is not intended for use with patients using pacemakers or electrical stimulators. Do not use if MR workers are present who have metallic wires, implants, stents, et cetera. Screen all MR workers for metallic wires, implants, stents, et cetera, prior to MR procedures when using the Expression MR400 MRI Patient Monitoring System in the MR magnet room. Do not use on patients with metallic wires, implants, stents, et cetera. Screen all patients for metallic wires, implants, stents, et cetera, 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. ExpressionMR400InstructionsforUseImportantInformation13 Training Usersofthisproductmusthavereceivedadequatetrainingonitssafeandeffectiveusebefore attemptingtooperatetheproductdescribedinthisInstructionsforUse.Trainingrequirements forthistypeofdevicewillvaryfromcountrytocountry.Usersmustmakesuretheyreceive adequatetraininginaccordancewithlocallawsorregulations.Ifyourequirefurtherinformation abouttrainingintheuseofthisproduct,pleasecontactyourlocalPhilipsMedicalSystems representative.Alternatively,contactthemanufacturer. ADEQUATETRAINING WARNINGS Do not use the product for any application until you have received adequate and proper training in its safe and effective operation. If you are unsure of your ability to operate this product safely and effectively DO NOT USE IT. Operation of this product without proper and adequate training could lead to fatal or other serious personal injury. It could also lead to clinical mis-diagnosis or to clinical mistreatment. Do not operate the product with patients unless you have an adequate understanding of its capabilities and functions. Using this product without such an understanding may compromise its effectiveness and/or reduce the safety of the patient, you and others. Safety BeforeusingtheExpressionMR400MRIPatientMonitoringSystem,readthesafetyinformation below.ThewarningsbelowrefertotheExpressionMR400MRIPatientMonitoringSysteminits entirety. MAINTENANCE&FAULTS Warning WARNING Do not use the product for any application until you are sure that the user routine-checks have been satisfactorily completed, and that the periodic maintenance of the product is up to date. If any part of the product is known (or suspected) to be defective or wrongly adjusted, DO NOT USE the product until a repair has been made. Operation of the product with defective or wrongly adjusted components could expose the user or the patient to safety hazards. This could lead to fatal or other serious personal injury, or to clinical misdiagnosis, or to clinical mistreatment. 14ImportantInformationExpressionMR400InstructionsforUse SAFETYAWARENESS SAFETYDEVICES Warning WARNING Do not use the product for any application until you have read, understood and know all the safety information, safety procedures and emergency procedures contained in this SAFETY section. Operation of the product without a proper awareness of how to use it safely could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis or to clinical mistreatment. Warning WARNING Never attempt to remove, modify, or over-ride or frustrate any safety device on the product. Interfering with safety devices could lead to fatal or other serious personal injury. INTENDEDUSEANDCOMPATIBILITY Warning WARNING Do not use the product for any purpose other than those for which it is intended. Do not use the product with any product other than that which Philips Medical Systems recognizes as compatible. Operation of the product for unintended purposes, or with incompatible product, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis or to clinical mistreatment. ELECTRICALSAFETY Warning WARNING Do not remove covers or cables from this product (unless expressly instructed to do so in this Instructions for Use). Dangerous electrical voltages are present within this product. Removing covers or cables could lead to serious or fatal personal injury. Covers or cables should [normally] only be removed by qualified and authorized service personnel. Use this product in rooms or areas that comply with all applicable law (or regulations having the force of law) concerning electrical safety for this type of product. Electrically isolate this product from the mains electrical supply before cleaning or disinfecting. Equipotential ground connection: An equipotential ground (earth) connection point is provided. Use this product in areas meeting local standards for electrical safety in rooms used for medical purposes, for example the US National Electrical Code. IEC 60601 also gives guidance about an equipotential ground (earth) connection point. Additional equipotential ground connection: An additional equipotential ground (earth) connection point is provided, because the product is transportable and the reliability of the main equipotential ground connection point might be insufficient. ExpressionMR400InstructionsforUseImportantInformation15 MECHANICALSAFETY FIRESAFETY Warning WARNING Do not remove covers from this product unless expressly instructed to do so in this Instructions for Use. Moving parts are present within this product. Removing covers could lead to serious or fatal personal injury. Covers should normally only be removed by qualified and authorized service personnel. In this context, qualified means those legally permitted to work on this type of medical electrical product in the jurisdiction(s) in which the product is being used, and authorized means those authorized by the user of the product. Useofanelectricalproductinanenvironmentforwhichitwasnotdesignedcanleadtofireor explosion.Fireregulationsforthetypeofmedicalareabeingusedshouldbefullyapplied, observedandenforced.Fireextinguishersshouldbeavailableforbothelectricalandnon electricalfires. Warning WARNING Only use extinguishers on electrical or chemical fires, which are specifically labeled for those purposes. Using water or other liquids on an electrical fire can lead to fatal or other serious personal injury. Ifitissafetodoso,attempttoisolatetheproductfromelectricalandothersuppliesbefore attemptingtofightafire.Thiswillreducetheriskofelectricshocks. ELECTROSTATICDISCHARGE Electrostaticdischarge(ESD)canamounttoasignificantvoltage,whichmaycausedamageto PCBsorothersystemcomponents. Caution CAUTIONS Always wait at least ten seconds after the product is switched OFF before switching the product back to ON. Always use proper static procedures, protection, and product prior to opening and during handling of this product. This product contains components that are electrostatic sensitive. Failure to use ESD procedures may cause damage to these components. Such damage to components is not covered by Philips warranties. ConnectionstosensitivepartsareidentifiedbytheESDwarningsymbol(see inset).ESDdamageiscumulativeandmaynotbeapparentatfirst,asindicated byahardfailure,butcancausedegradedperformance.Therefore,alwaysuse properESDhandlingprocedures.ESDcanresultfromlowhumidityconditions, useofelectricalequipmentoncarpeting,linens,andclothing. 16ImportantInformationExpressionMR400InstructionsforUse ELECTROMAGNETICCOMPATIBILITY(EMC) ThisPhilipsproductcomplieswithrelevantinternationalandnationallawandstandardsonEMC

(electromagneticcompatibility)forthistypeofproductwhenusedasintended.Suchlawsand standardsdefineboththepermissibleelectromagneticemissionlevelsfromproductandits requiredimmunitytoelectromagneticinterferencefromexternalsources. OtherelectronicproductsexceedingthelimitsdefinedinsuchEMCstandardscould,under unusualcircumstances,affecttheoperationoftheproduct. MedicalelectricalproductsneedsspecialprecautionsregardingEMC,andneedstobe installedandputintoserviceaccordingtoEMCinformationprovidedinthisInstructionsfor Use. Theuseofaccessoriesandcablesotherthanthosespecified,mayresultinincreased emissionordecreasedimmunitylevels. Theproductshouldnotbeusedadjacenttoorstackedwithotherproductsandthatif adjacentorstackeduseisnecessary,itshouldbeobservedtoverifynormaloperation. CAUTION Portable and Mobile Phones Portable and mobile RF communications can affect medical electrical equipment. Use caution when using such communication devices within the specified range of medical electrical devices. The Expression MR400 MRI Patient Monitoring System may be interfered with by other equipment with CISPR emission requirements. Equipment Classification (According to IEC 60601-1) According to the type of protection against electrical shock:

According to the degree of protection against electrical shock:

According to the degree of ingress protection:

Class I equipment Type CF (defibrillator-proof) equipment Rated IP21: Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12.5mm (0.5 inch); and, protected against vertically dripping liquid. Non-sterilizable; use of liquid surface disinfectants only Continuous operation 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. ExpressionMR400InstructionsforUseImportantInformation17 Electromagnetic Compatibility (EMC) Thedeviceisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Giventhe deviceselectromagneticemissionsandimmunitycharacteristics,thecustomerorusershould assurethatthedeviceisusedwithinsuchanenvironment.Thefollowinginformationis mandatedbyIEC6060112,theinternationalstandardfortheelectromagneticcompatibility

(EMC)ofmedicalelectricalequipment. Radios INDUSTRYCANADASTATEMENT ThisdevicecomplieswithIndustryCanadalicenseexemptRSSstandard(s).Operationissubjectto thefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevicemust acceptanyinterference,includinginterferencethatmaycauseundesiredoperationofthedevice. LeprsentappareilestconformeauxCNRd'IndustrieCanadaapplicablesauxappareilsradio exemptsdelicence.L'exploitationestautoriseauxdeuxconditionssuivantes:(1)l'appareilne doitpasproduiredebrouillage,et(2)l'utilisateurdel'appareildoitacceptertoutbrouillage radiolectriquesubi,mmesilebrouillageestsusceptibled'encompromettrelefonctionnement. FCCCOMPLIANCESTATEMENT CAUTION Changes or modifications not expressly approved could void your authority to use this equipment Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowingtwo conditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemustaccept anyinterferencereceived,includinginterferencethatmaycauseundesiredoperation. FrequencyRange:24022482MHz ModulationType:GFSK WPUEIRP:4.2dBm(peak) wECGandwSpO2EIRP:0dBm(peak) Warning WARNING The use of accessories, transducers and cables other than those specified in the accessory list accompanying this 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. 18ImportantInformationExpressionMR400InstructionsforUse Guidance and Manufacturers Declaration - Electromagnetic Emissions The Expression MR400 MRI Patient Monitoring System 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 Group 1 RF Emissions, CISPR 11 Harmonic Emissions, IEC 61000-3-2 Class B Class B Voltage Fluctuations / Flicker Emissions, IEC 61000-3-3 Complies The Expression MR400 MRI Patient Monitoring System 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 Expression MR400 MRI Patient Monitoring System 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. ExpressionMR400InstructionsforUseImportantInformation19 Guidance and Manufacturers Declaration - Electromagnetic Immunity The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System 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 Expression MR400 MRI Patient Monitoring System requires continued operation during AC power interruptions, power from an uninterruptible 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. 110ImportantInformationExpressionMR400InstructionsforUse Guidance and Manufacturers Declaration - Electromagnetic Immunity The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System 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 Expression MR400 MRI Patient Monitoring System, 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 Expression MR400 MRI Patient Monitoring System is used exceeds the applicable RF compliance level above, the Expression MR400 MRI Patient Monitoring System should be observed to ensure normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Expression MR400 MRI Patient Monitoring System. b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. ExpressionMR400InstructionsforUseImportantInformation111 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Expression MR400 MRI Patient Monitoring System The Expression MR400 MRI Patient Monitoring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Expression MR400 MRI Patient Monitoring System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Expression MR400 MRI Patient Monitoring System 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.Thebatterylifeisatanendwhentheequipmentoperatingtime providedbybatterypowerbecomesmuchshorterthanusual(i.e.,whenthetotalbattery capacityhasonly70percentitsinitialcapacity).Foroptimalbatterylife,pleasefollowthese guidelines:

Donotstorethebatteriesinadischargedcondition.Alwayschargeabatterytoatleast40 percentofcapacitybeforestoring. Chargethebatteriesonceamonthwhennotinuse. Immediatelyremoveanybatterythathasanexpiredlifecycleandreplaceitwithanewbattery ofthesametype.(Refertopage137forpartnumbers.)Toensurethesafetyofoperatorsand patients,observethefollowingwarningsandcautions. 112ImportantInformationExpressionMR400InstructionsforUse Warning WARNING Do not use a damaged battery. Periodically check batteries, stop using and replace 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. Caution CAUTIONS If the battery contacts become dirty, wipe them clean with a dry cloth before use. Do not immerse in a battery in water or other liquids. Store batteries in a dry place, between 0 to 40C (32 to 104F) . Do not expose a battery to temperatures above 60C (140F). Do not short the external battery contacts. Keep metal objects away from the battery contacts. Store each battery in a manner that prevents shorting with the container or another cell/

battery. Only use the Philips specified charger. Examining the Shipment Toreportshippingdamage,ortoresolveanyissuesorconcernswithyourorder,contact CustomerService.(Saveallpackingmaterialsandrelatedshippingdocuments,asthesemaybe requiredtoprocessashippingdamageclaimwiththecarrier.) Afterremovingthecontentsfromtheshippingcontainers,carefullyexamineallitemsforsignsof damagethatmayhaveoccurredduringshipment.Also,checkallitemsagainsttheincluded packinglistandthepurchaserequest. Thecontentsofthecrateshouldinclude:

ExpressionMR400MRIPatientMonitoringSystem Twomainbatteries InstructionsforUse(IFU)manual QuickReferenceGuide(includedinEnglishlocalizedshipmentsonly) PowerCord Aseparatecontainermayincludeadditionalitems:

WirelessECGpatientmodule(Gen3) WirelessSpO2patientmodule(Gen3) ExpressionMR400InstructionsforUseImportantInformation113 Modulebatterycharger Modulebatteries Disposing of the Packaging Thepackagingcanberetainedforfutureuse.Otherwise,thepackagingforthesystem(whichis madeofrecyclablematerialsthatincludecorrugatedpaper,polyethylene[PE]foamandplastic) maybesubjecttodisposalregulationsforuserandenvironmentalsafety.Fordisposal,itmaybe necessarytoseparatethesematerialsbytype.Alwaysobserveandadheretoyourcurrentlocal regulationswhendisposingofthepackagingmaterial. Initial Setup TheinstructionsbelowdetailtheinitialsetupprocessforafullyequippedExpressionMR400MRI PatientMonitoringSystem(hereafterreferredtoastheMR400)includingthewirelessECG patientmodule(hereafterreferredtoasthewECGmodule)andthewirelessSpO2patient module(hereafterreferredtoasthewSpO2module)andhereafterreferredtocollectivelyas wirelessmodules. DependingupontheneedsofyourfacilityandtheMR400optionspurchased,thestepsyou followmaydifferandsomemaynotberequired.Forthelocationofcomponentsnotdetailed below,seechapter2. WARNINGS Only perform initial setup of the MR400 at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury. No modification of this equipment is allowed. Failure to observe this warning may result in serious injury. CAUTION The MR400 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. 114ImportantInformationExpressionMR400InstructionsforUse ToperforminitialsetupoftheMR400 Step 1 Action PerformavisualinspectionoftheMR400,checkingforlooseor missinghardwareordamage. 2 3 4 5 6 7 8 9 Iflooseormissinghardwareordamageisobserved,contact technicalsupport. Installthemainbatteriesintothecartandconnectthereserve batteries;seepage116. ConnectACmainspowertotheMR400,butDONOTturnonthe powerswitch.Allowthebatteriestochargeforatleast12hours beforeuse;seepage120. Note Before initial use, charge the batteries in the cart for at least 12 hours with the MR400 turned off and connected to AC mains power. IfwECGandwSpO2moduleswereincluded,performavisual inspectionofthedevicesforlooseormissinghardwareordamage. IfawSpO2modulewasincluded,attachanSPO2probetoit;see page118. Ifmodulebatterieswereincluded,chargethemodulebatteries usingthePhilipsspecifiedbatterycharger.(Refertothe instructionsprovidedwiththecharger.) Note Before initial use, charge the module batteries for at least 4 hours. Pressthepowerswitch(onthefrontofthecart)thenverifythatthe MR400hassuccessfullypoweredupandthatthepowerLEDis steadygreen. Forotherpossibleindications,seepage27. IfequippedwithanIP5,verifythattheMR400andIP5aresettothe samewirelessnetworkchannelbycheckingthenetworkicon(see examplesbelow)thatisdisplayedbyeachdevice. Seepage127forMR400networksettinginstructions;and,referto theIFUfortheIP5fornetworksettinginstructions. IfwECGandwSpO2moduleswereincluded,installthecharged modulebattery(orbatteries)intothedevice(s);seepage124for thewECGmoduleandseepage126forwSpO2module. ExpressionMR400InstructionsforUseImportantInformation115 Step 10 Action VerifythatthestatusindicatoronthewECGandwSpO2modulesis illuminatedsteadygreen:

ForthewECGmodule,seepage29. ForthewSpO2module,seepage211. 11 12 VerifythatthewirelessnetworkchannelsonthewECGandwSpO2 modulesaresettothechannelusedbytheMR400;seepage129. PlacethewECGandwSpO2modulesintothemoduleholderson theMR400;seepage212. Thiscompletestheinitialsetupprocess.Forinformationregarding otherpossibleMR400connections;seeRearPanelConnectionson page119. Installing and Connecting 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 MR400. The batteries will be attracted to the magnetic field, possibly causing patient or user injury. CAUTION Never force a main battery into a battery compartment as it will damage the battery and/or the cart. FourbatteriesareusedintheMR400:

Twomainbatteriesmustbeinsertedoneintotheleftbatterycompartmentandoneinto therightbatterycompartmentofthecart;and, Tworeservebatteries,internallyhousedinthecart,mustbeswitchedon. Toinstallandconnectthemainandreservebatteries Step 1 Action Locatethebatterycompartments,whichareunderneaththeWPU ontheleftandrightsidesofthecart. 116ImportantInformationExpressionMR400InstructionsforUse Step 2 Action Holdamaincartbatterywiththelabelsidedownandwithits connectorfacingforward.(Silkscreeningaboveeachbattery compartmentprovidesthecorrectbatteryorientationtheleft sideisshownintheexamplebelow.)Then,slidethebattery completelyintothebatterycompartmentuntilaclickisheardas thebatterylatchesintoplace. WPU Battery compartment Main cart battery

(Ifthebatterydoesnotlatchintoplacewheninserted,thenitis notproperlyoriented.Inthiscase,remove,reorientcorrectly,and thenreinsertthebattery.) Repeatsteps1and2toinstalltheremainingmaincartbatteryon theoppositesideofthecart. Removetheshieldcapfromthegatingconnectorandthetwo screwsthatsecuretheservicepanelcovertothebackoftheWPU thenremovetheservicepanelcover. 3 4 Screws Service panel cover Shield cap ExpressionMR400InstructionsforUseImportantInformation117 Step 5 Action LocatethebatteryswitchandtoggleitintotheOn(I)position. Battery switch 6 7 Reinstalltheservicepanelcover,andsecureittotheWPUusing thetwoscrews. Replacetheshieldcap. Thiscompletestheinstallationandconnectionofthemainand reservebatteries.ConnectACmainspowerthenallowthese batteriestochargeforatleast12hoursbeforeinitialuse;seepage 121. Attaching the SpO2 Probe to the wSpO2 Module TheSpO2probe,necessaryfortakingSpO2relatedmeasurementsusingthewSpO2module, mustbeconnectedprioruse. WARNINGS Only perform this attachment at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury. Connecting an other than specified SPO2 probe to the wSpO2 module can cause inaccurate SPO2 readings and damage the module. ToattachtheSPO2probe InserttheSPO2probeconnectorintotheDB9connectoronthewSpO2 modulethensecurelytightenbothscrews. 1 2 3 4 wSpO2 module DB-9 connector SPO2 probe connector Screws 1 2 3 4 118ImportantInformationExpressionMR400InstructionsforUse Rear Panel Connections DependingupontheoptionsincludedwithyourMR400ortheusemodel,someconnectionsmay berequiredaftermovingtheMR400intotheMRmagnetroom.Inadditiontotheconnectionfor ACmainspower,connectionsforthewastegasportandthegatingcableareavailableonthe rearpaneloftheMR400.(ForinformationabouttheplacementoftheMR400intheMRmagnet room,seepage32.) CAUTION When making connections to the rear panel of the MR400, ensure that the final installation complies with IEC 60601-1, clause 16, Medical Electrical (ME) Systems, to assure operator and patient safety. Always check the summation of leakage currents when the MR400 is connected to additional external equipment. Wheretheintegrityoftheexternalprotectiveconductorintheinstallationoritsarrangementis indoubt,theMR400shallbeoperatedfrombatteries. 5 4 1 2 3 1 Gating connector for gating control connections to the MR system. (Gating cables are type-dependent; see page 1-35.) 2 Waste gas port (if equipped) for connection of exhausted sam-

pled respiratory gases from the MR400 to your facilitys gas scaveng-

ing system; suggested tubing requirement: 3.175 mm (0.125 inch) outer diameter, 1.6 mm (0.063 inch) inner diameter. 3 Ground lug (equipotential ground [earth] connection point) allows for electrical safety testing; and, allows authorized service personnel to connect a ground strap for prevention of ESD during servicing. ExpressionMR400InstructionsforUseImportantInformation119 4 5 Strain relief for retention of the power cord. AC receptacle for connection of the power cord. Connecting AC Mains Power WhenconnectingtheMR400tothemainselectricalsupply,donotroutethedetachablepower cordwhereitwillbeanobstructionorsteppedupon.DonotblockaccesstotheMR400with otherequipmentandneverpositiontheMR400insuchawaythatwouldmakeitdifficultto unplug. WARNINGS Only use the supplied power cord and connect to properly grounded AC outlets to avoid electrical shock. Avoid use of electrical extension cords or multiple portable socket outlets, which may create a safety hazard by compromising the grounding integrity of the MR400. ToconnectACmainspower Step 1 2 3 4 5 6 Action Ensurethatallcartbatteriesareinstalledandswitchedon;see page116fordetails. IfplacingtheMR400intheMRmagnetroom,positiontheMR400 ataproperlocation;seepage32. Raisethestrainrelief;seepage120forthelocation. PlugthepowercordintotheACreceptacleontheMR400;see page120forthelocation. Foraddedmobility,thepowercordextension(REF989803168221) canalsobeconnected. Lowerthestrainreliefoverthepowercord. PlugthepowercordintoanapprovedACmainsoutlet. ToremovetheMR400fromACmainspower PulltheplugofpowercordfromtheACwalloutlet.Then,liftthestrainreliefandremovethe powercordfromtheACreceptacleontherearoftheMR400.Storethecordinasafeplace. 120ImportantInformationExpressionMR400InstructionsforUse Understanding Battery Operations Cart Batteries Warning WARNING Do not touch the patient and the circuitry in the battery compartments of the MR400 simultaneously. Cartbatteries,wheninstalled(main)andswitchedon(reserve),arechargedandconditionedby anintegratedchargingsystem.WhenturnedonandconnectedtoACmains,theMR400operates fromACpowerandsimultaneouslychargesallcartbatteries.Whenturnedoffandconnectedto ACmains,batterychargingfunctionscontinue. Ifatanytime,ACmainsislost,theMR400willautomaticallyswitchtobatterypowertoprovide uninterruptedservicethen,whenACmainsisrestored,theMR400willautomatically,without delay,revertbacktoACpowerfunctions.IfthereservebatteriesarefullydepletedandACmains islost,thentheunitwillpoweroff. TheMR400smaximumoperatingtimeonbatterypowerdependsupontheenabledparameters andthetypeandfrequencyofmonitoringfunctions(seetheBattery,OperationTimeonpageA4 foralisting). Charging Cart Batteries Cartbatteriesmustbechargedbeforeinitialuse.Duringinitialsetuporwheninstallingnew batteries,chargethecartbatteriesforatleast12hourssothattheyarefullychargedand conditionedforoperation. Notes Use only with the specified battery charger. The main batteries must always be inserted and the reserve batteries must always be switched on to prevent loss of patient monitoring during a power outage. If main batteries are not inserted and if the reserve batteries are not switched on, then during power outage unsaved user settings will revert to factory defaults. We recommend plugging the MR400 into a backup generator or equivalent means to prevent a lapse in patient monitoring during a power loss. ExpressionMR400InstructionsforUseImportantInformation121 Tochargethecartbatteries Step 1 Action Ensurethatallcartbatteriesareinstalledandswitchedon. SeeInstallingandConnectingCartBatteriesonpage116for details. ConnecttheMR400toACmainspower. SeeConnectingACMainsPoweronpage120. EnsurethattheMR400isturnedoffandthatitremainsoffforthe next12hours. 2 3 Chargedcapacityofallcartbatteriescanbedisplayed;seetheStatusInformationPanelonpage 218). Chargedcapacitycanalsobefoundbypressingthepowerlevel buttononeachmaincartbattery,wherethecurrentlevelis providedbythechargeindicator;seeRemovingCartBatteries, below. 1 2 1 2 3 Charge indicator Power level button Cart battery 3 Removing Cart Batteries Toremovethemainbatteries Step 1 Action Locatethebatteryejectbutton,whichisinarecessedareaunder eachbatterycompartmentontheleftandrightsidesofthecart. 122ImportantInformationExpressionMR400InstructionsforUse 2 Pressthebatteryejectbuttontopartiallyejectamainbatteryfrom thebatterycompartment,andthengraspthebatteryandpullto removeitcompletelyfromtheMR400. Battery compartment Battery eject button Main battery

(Ifthebatterydoesnotrelease,applyaslightforwardpressureto thebatterywhilepressingthebatteryejectbutton.) Repeatsteps1and2toremovetheothermaincartbatteryonthe oppositesideoftheMR400. 3 Note The reserve batteries cannot be removed, but can be switched off. For instructions on the complete removal of power to the MR400, see page 14-2. Wireless Module Batteries ModulebatteriesprovidepowertothewECGandwSpO2modules.Modulebatteriesare interchangeable,nonmagnetic,andcanbehandledsafelyintheMRmagnetroom. CAUTION To minimize the chance of image artifacts, never place module batteries in the MRI field of view. ExpressionMR400InstructionsforUseImportantInformation123 Charging Module Batteries Modulebatteriesmustbechargedforatleast4hoursbeforeinitialuse.Modulebatteriesare chargedinthePhilipsspecifiedbatterycharger.Refertotheinstructionsprovidedwiththis batterychargerforinformation. Installing Batteries in the wECG Module ThewECGmodulecanacceptuptotwobatteries.Dependinguponthenumberofbatteries installed,thewECGmoduleprovidedifferentoperationalfeatures:

Ifonebatteryisinstalled,thenthewECGmodulewillturnonandfunctionnormallybut beforeitschargeisexhausted,asecondbatterymustbeinstalledinordertocontinuethe ECGstudy. Iftwobatteriesareinstalled,thenseamlessoperationispossibleonebatterywillprovide poweruntilitschargeisexhausted,atwhichtimethewECGmodulewillautomatically switchtotheremainingbatteryforcontinuedoperation.Aslongassufficientpoweris providedbythesecondbattery,continuedoperationispossible.And,anexhausted batterycanbereplacedatanytimewithoutinterruptiontotheECGstudy,providedthat sufficientchargeispresentontheremainingbattery. IndicatorsidentifythesourcebatterybeingusedbythewECGmodule;seepage29. Whenbothbatteriesareremoved,thewECGmodulewillturnoff. ToinstallbatteriesinthewECGmodule Step 1 Action HoldthewECGmodulesothatitsbatterybaysareorientedas shown,withbatterybay1inthelowerpositionandbatterybay2 intheupperposition. wECG module Bay 2 Bay 1 124ImportantInformationExpressionMR400InstructionsforUse Step 2 Action Orientamodulebatterysothatthetipofthebatteryarrowaligns withthetipofthebay1arrowonthewECGmodule.Thenslidethe modulebatteryintobay1,pressinguntilitseatscompletely. Module battery Bay 1 arrow Battery arrow 3 Orientamodulebatterysothatthetipofthebatteryarrowaligns withthetipofthebay2arrowonthewECGmodule.Thenslidethe modulebatteryintobay2,pressinguntilitseatscompletely. Bay 2 arrow Module battery Battery arrow Removing Batteries from the wECG Module Toremovebattery1fromthewECGmodule Pressabatteryejectbutton1(item1,right).Then graspthepartiallyejectedmodulebattery(item2) andpulltoremoveit. 1 2 ExpressionMR400InstructionsforUseImportantInformation125 Toremovebattery2fromthewECGmodule Pressabatteryejectbutton2(item3,right).Then graspthepartiallyejectedmodulebattery(item4) andpulltoremoveit. 3 4 Installing a Battery in the wSpO2 Module ThewSpO2moduleusesonebattery.Whenamodulebatteryisinserted,thewSpO2modulewill turnon.And,whenthebatteryisremoved,thewSpO2modulewillturnoff. ToinstallabatteryinthewSpO2module Step 1 Action HoldthewSpO2modulesothatitsbatterybayisorientedas shown. wSpO2 module Battery bay 2 Orientamodulebatterysothatthetipofthebatteryarrowaligns withthetipofthebayarrowonthewSpO2module.Thenslidethe modulebatteryintothebatterybay,pressinguntilitseats completely. Module battery Bay arrow Battery arrow 126ImportantInformationExpressionMR400InstructionsforUse Removing the Battery from the wSpO2 Module ToremovethebatteryfromthewSpO2module Pressthebatteryejectbutton(item1,right).Then graspthepartiallyejectedmodulebattery(item2) andpulltoremoveit. 1 2 Understanding Wireless Network Operations AwirelessnetworkchannelisusedforsystemcommunicationbetweentheMR400cartandthe wECGandwSpO2modules(and,ifequipped,theIP5).Allwirelessdevicesmustusethesame wirelessnetworkchannelforpropersystemcommunications.Also,wheremultipleInvivo(Royal Philips)MRIpatientmonitoringsystemsareinuse,theselectedwirelessnetworkchannelshould benotusedbyanyothersysteminyourfacility(forthefrequencyrange,seepage18). Setting the Wireless Network Channel of the Cart AllcontrolsforselectingthewirelessnetworkchanneloftheMR400arelocatedonthecarts touchscreen.Uniquesymbolsandnumbersareusedtoidentifyeachavailablechannelforthe MR400,asshownbelow. Network channel 1 Network channel 2 Network channel 3 Network channel 4 Network channel 6 Network channel 7 Network channel 8 Network channel 9 Network channel 5 Network channel 10 ExpressionMR400InstructionsforUseImportantInformation127 WARNINGS Care should be taken to guard against inadvertent changes to the network channel setting. Before use, always ensure that all devices are communicating properly. Failure to do so may cause a lapse in patient monitoring. An MR400 system is comprised of one MR400 cart, one wECG module, and one wSpO2 module, and optionally an IP5. In environments where multiple MR400 MRI patient monitoring systems are being used, you must be aware of each components network setting. Operating multiple MR400 systems 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. If a patient is currently admitted, a warning dialog box will prompt you before a change to the monitor network is allowed. After changing the wireless network channel of the MR400, you must wait a minimum of 5 seconds before removing power from the system; otherwise, the change will be lost. Notes TosetthewirelessnetworkchannelfortheMR400cart Step 1 Action Pressthepowerswitch(seepage27forthelocation)thenallow theMR400toinitialize. Themainscreenappears. Selectthenetworkicon. 2 Network menu Thenetworkmenuappears. Network icon 128ImportantInformationExpressionMR400InstructionsforUse Step 3 Action Selectthedesiredsettingfromtheoptions:

1 2 3 4 5 6 7 8 9 10 4 Thesettingisenteredandthenetworkiconischangedtothe currentselection. EnsurethatthenetworkchannelusedbythewECGandwSpO2 modules(seepage129)andtheIP5(ifequipped)areidenticalto thenetworksettingofthecart. Setting the Wireless Network Channel of the wECG and wSpO2 Modules Allindicatorsandcontrolsforwirelessnetworkchannelselectionarelocatedonthefrontofthe wirelessmodules.Twodifferentgroupsoffivewirelessnetworkchannelsareavailable(channels 15,orchannels610)andbothmodulesmustbeofthesamegroup,dependinguponyour selectionattimeofpurchase. Note The wECG and wSpO2 modules may arrive preprogrammed to match the network channel setting of your MR400, thus eliminating the need to change the channel setting. Thewirelessnetworkchannelforamoduleischangedbyusingthe networkselectionbutton.Thewirelessnetworkchannelfora moduleshouldbesettomatchthewirelessnetworkchannelused bytheMR400;seepage127. 1 2 Network channel indicators Network selection button Thefollowingdirectionsforchangingthewirelessnetworkchannel applytobothwirelessmodulesandtoeitherchannelgroup,though theprocessbelowdepictsthewSpO2moduleandchannelgroup1 5.(FormoreoperationaldetailsaboutthewECGmodule,seepage 29;and,forthewSpO2module,seepage211.) 1 2 ExpressionMR400InstructionsforUseImportantInformation129 Beforestartingtheproceduretochangethenetworkchannelofthewirelessmodule,takenoteof theseconventionsthatareusedtoexplaintheprocess:

Thefollowingsymbolsareusedtoconveythestateofthenetworkchannelindicatorona wirelessmodule. Symbolilluminated Symbolblinking Thefollowingillustrationsareusedtoconveyactionsconcerningtheuseofthenetwork selectionbutton. Pressingthe button Pressingandholding thebutton Releasingthe button Repeating TosetthewirelessnetworkchannelofthewECGorwSpO2module Step Action 1 Turnoffthewirelessmodule:

wECGmoduleseeRemovingBatteriesfromthewECG Moduleonpage125. wSpO2moduleseeRemovingtheBatteryfromthewSpO2 Moduleonpage127. 2 Turnonthewirelessmodule:

wECGmoduleseeInstallingBatteriesinthewECGModule onpage124. wSpO2moduleseeInstallingaBatteryinthewSpO2 Moduleonpage126. Thenetworkchannelindicatorswillflashbrieflyandthenthe currentnetworkchannelindicatorwillilluminate(forexample,3 intheillustrationbelow). 130ImportantInformationExpressionMR400InstructionsforUse Step Action 3 Enterthenetworkchannelchangemode:Afterthecurrent networkchannelindicatorhasbeenilluminated(andwithin10 secondsofmodulepowerup),pressandholdthenetwork selectionbuttonuntilthecurrentnetworkchannelindicatorbegins torapidlyblinkthenreleasethebutton. Note If the network channel change sequence was not started within 10 seconds after the module has been turned on, network channel changes will not be allowed. In this case, you must cycle module power and restart the sequence. 4 Pressdownagainonthenetworkselectionbuttonuntilthesymbol stopsblinkingandthenreleasethebuttontochangethenetwork channelsetting. Whenyoudothis,thenextnetworkchannelindicatorinthe sequencewillblinkrapidly.(Inotherwords,ifthemodulewas originallyusingnetworkchannel3,nowthe4symbolwillbe blinking.)Repeatthissequenceofpressingdownandreleasingthe buttonuntilthesymbolofthenetworkchannelyoupreferis rapidlyblinking.Ifyoupassthedesiredchannel,simplycontinue pressingandreleasingthebuttonuntilthedesirednetwork channelindicatorisblinkingagain. ExpressionMR400InstructionsforUseImportantInformation131 Step Action 5 Whenyoureachthedesiredsymbol,pressandholdthebuttonfor approximately5secondstolockandsavethenewsetting. Theselectednetworkchannel'ssymbolwillturnoffwhilethe buttonisdepressed.Thenitwillilluminate(notblink)whenthe newnetworkchannelsettingissaved.Onceilluminated,release thebutton.Themodulewillbeginusingtheselectednetwork channel. Note Any part the network channel change sequence not completed will cause the module to revert to the network channel previously set 30 seconds after the network selection button was last released. 132ImportantInformationExpressionMR400InstructionsforUse Advanced User Options Expression Information Portal (Model IP5) ProvidingsystemcontroloutsidetheMRmagnetroom,the ExpressionInformationPortal(ModelIP5),hereafterreferred toastheIP5,isawirelessdevicethatalsofeaturesprinting capabilitiesandHL7dataoutputoptions. TheMR400usesawirelessconnectionforcommunication withtheIP5.TheIP5sconnectiontothehospitalinformation system(HIS)isexplainedindetailintheIP5IFU.Whenusing theIP5toconnecttotheHIS,adheretoallcautionsandsafety instructionsfoundintheIP5IFU. Additional Options Additionaloptionsmaybesuggestedbyyourbiomedicaltechniciantoincreaseuserease. Consultyourbiomedicaltechnicianortechnicalsupportwithspecificrequests. Caution CAUTIONS When adding equipment to an MR400 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, et cetera. Unauthorized modification to the radios/and/or antennas may cause the device to no longer be in compliance with applicable regulatory standards 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 MR400 system or device communications. Accessory List Accessoriesarelistedinthetablesbelowwithpartnumber(REF)information.Whereapplicable, theoriginalpartnumberhasalsobeenincludedforreference.Foradditionalinformationabout theseaccessories,pleaseconsultthedocumentationthataccompaniestheaccessory. ExpressionMR400InstructionsforUseImportantInformation133 Warning WARNING The MR400 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 MR400. Patient injury or loss of monitoring may result if incorrect accessories are used. Warning WARNING Do not use sterile items if the packaging is damaged. Patient injury may result if non-sterile accessories are used. CAUTION Modifications to the MR400 System during its service life are required to be evaluated to the requirements of IEC 60601-1. AGENT CANNULA, DISP, ADULT CANNULA, DISP, ADULT CANNULA,DISP,INT INF,(DIVIDED) CANNULA,DISP,PED,(DIVIDED) CANNULA,DISP,INFANT,(DIVIDED) CANNULA, DISP, INT INFANT CANNULA, DISP, PED CANNULA, DISP, INFANT ANESTHETIC OXYGEN (O2) SENSOR KIT,DISPOSABLE WATER TRAP,3160 KIT,SAMPLE,AGENTS,3160 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 Original Part Number REF 9012 9016 9016B 9016C 9016A 9015 9013 9014 94012 94018 989803152561 989803152601 989803152621 989803152631 989803152611 989803152591 989803152571 989803152581 989803162051 989803152671 989803152661 REF 989803183241 989803183251 989803183261 989803183271 134ImportantInformationExpressionMR400InstructionsforUse CO2 LOFLO LINE, PED DVD CANNULA, BOX 20 LOFLO LINE, ADU AIRWAY ADPT, BOX 20 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 EXPRESSION MR ECG LEADS, AAMI, CV EXPRESSION MR ECG LEADS, AAMI, STANDARD EXPRESSION MR ECG LEADS, AAMI, NEONATAL EXPRESSION MR ECG LEADS, IEC, CV EXPRESSION MR ECG LEADS, IEC, STANDARD EXPRESSION MR ECG LEADS, IEC, NEONATAL QUADTRODE MRI ECG PAD, 25/BOX ELCTRD, MRI ECG, QUTRD.CV, 25/BOX ELCTRD, MRI, NEO.QUDTRD, 25/BOX WIRELESS ECG PATIENT MODULE (GEN 3) 1-5 WIRELESS ECG PATIENT MODULE (GEN 3) 6-10 REF 989803183281 989803183291 989803185331 989803185341 989803185351 989803185361 989803185371 989803185381 Original Part Number REF 9009 989803152291 989803193721 989803193731 989803193741 989803193751 989803193761 989803193771 989803179031 989803179041 989803179051 989803192761 989803194341 Gating CAB, DIGITAL GATING, GE, 3160 CAB, GATING, SIEMENS, 3160 UNIVERSAL GATING INTERFACE CAB, DIG.GATING, HIT/TOSH, 3160 Original Part Number REF 9292 9291 9293 989803152821 989803152831 989803195521 989803152851 ExpressionMR400InstructionsforUseImportantInformation135 Invasive Blood Pressure 989803194601 EXPRESSION MR IBP TRANSDUCER CABLE, 5FT 989803194631 EXPRESSION MR IBP DPT KIT, A/P, BOX 20 EXPRESSION MR IBP DPT KIT, I/N, BOX 20 989803194641

(Note that Hospira [Transpac models], and Edwards Lifesciences [Transducer, Model PX260 and adapter cables], have also been qualified for use. Please contact Hospira or Edwards Lifesciences for information about Invivo-

compatible devices, and contact your sales representative with any questions.) REF Non-invasive Blood Pressure (NIBP) 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, 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 REF 989803182611 989803182621 989803182631 989803182641 989803182651 989803182661 989803182671 989803182681 989803182511 989803182521 989803182531 989803182541 989803182551 989803182561 989803182571 989803182581 989803183171 989803183181 989803183191 989803183201 989803183211 136ImportantInformationExpressionMR400InstructionsforUse Non-invasive Blood Pressure (NIBP) ADULT PRESSURE INTERCONNECT HOSE NEONATAL PRESSURE INTERCONNECT HOSE REF 989803183221 989803183231 Respiration (Pneumatic) PNEUMOGRAPH,CHEST,NM,3160 Original Part Number REF 94023 989803152791 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 (GEN 3) 1-5 WIRELESS SPO2 PATIENT MODULE (GEN 3) 6-10 System BATTERY, MODULE (GEN 3) BATTERY, MRI, 14.8V, 5.08 AH, UL EXPRESSION INFORMATION PORTAL (IP5) ADVANCED COMMUNICATIONS OPTION 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 REF 989803161991 989803166531 989803166541 989803166551 989803166561 989803166571 989803166581 989803192771 989803194331 REF 989803191341 989803169491 865471 989803176521 453564177501 989803168211 989803168221 989803173901 989803174171 989803181291 989803181321 ExpressionMR400InstructionsforUseImportantInformation137 System POWER CORD, DANISH, 3 METER POWER CORD, ISRAELI, 3 METER POWER CORD, ARGENTINA, 3 METER POWER CORD, SWISS, 3 METER Temperature FLEXTEMP II SENSOR (ESOPHAGEAL/RECTAL/AXILLARY, DIRECT MODE) SURGICAL LUBRICANT, 12 PACK FLEXTEMP SYSTEM, JACKET (BOX 10) Miscellaneous MR400 QUICK REFERENCE GUIDE MANUAL, SERVICE, MR400 MANUAL, OPERATOR, MR400, DANISH MANUAL, OPERATOR, MR400, DUTCH MANUAL, OPERATOR, MR400, ENGLISH MANUAL, OPERATOR, MR400, FINNISH MANUAL, OPERATOR, MR400, FRENCH MANUAL, OPERATOR, MR400, GERMAN MANUAL, OPERATOR, MR400, INDONESIAN MANUAL, OPERATOR, MR400, ITALIAN MANUAL, OPERATOR, MR400, JAPANESE MANUAL, OPERATOR, MR400, KOREAN MANUAL, OPERATOR, MR400, NORWEGIAN MANUAL, OPERATOR, MR400, POLISH MANUAL, OPERATOR, MR400, PORTUGUESE MANUAL, OPERATOR, MR400, RUSSIAN MANUAL, OPERATOR, MR400, SPANISH MANUAL, OPERATOR, MR400, SWEDISH REF 989803181331 989803181341 989803181351 989803181361 REF 989803194511 989803168891 989803178181 REF 453564557591 989803195211 989803193191 989803193201 989803193211 989803193221 989803193231 989803193241 989803193251 989803193261 989803193271 989803193281 989803193291 989803193301 989803193311 989803193321 989803193331 989803193341 138ImportantInformationExpressionMR400InstructionsforUse Miscellaneous MANUAL, OPERATOR, MR400, TRAD. CHINESE MANUAL, OPERATOR, MR400, TURKISH REF 989803193351 989803193361 ExpressionMR400InstructionsforUseImportantInformation139 140ImportantInformationExpressionMR400InstructionsforUse CHAPTER 2 System Overview TheMR400isdesignedtoprovidemultivitalsignpatientmonitoringandMRIgatingcapabilityin theMRIenvironmentwhileincloseproximitytoanMRIscannermagnet.Themonitoring capabilitiesoftheMR400canbeconfiguredtomeettheneedsofawidespectrumofpatients fromneonatetoadult.Everyparametercanbeaccessedandadjustedfortheuniqueconditionof eachpatient.TheMR400accommodatesspecificmonitoringneeds,including:

Adult,pediatricandneonatalpatients Criticallyillpatients Patientundergoingsedation PatienttransportwithintheMRenvironment Interventionalprocedures Cardiacgating Note We recommend the establishment of a program for supervision appropriate to the classes and types of patients, and that all patients should receive at least routine monitoring when the MR400 is in use. System Parameters TheMR400simultaneouslyprocessesanddisplaysmultipleparameters,waveforms, measurementnumericvaluesandalarms.Allpatientinformationisprovidedonthetouch screen.AfullyequippedMR400includesmonitoringforthefollowingparameters:

Electrocardiogram(ECG),dualchannel Heartrate(HR) Bloodoxygensaturation/pulseoximetry(SPO2) EndtidalandfractionalinspiredCO2(EtCO2andFiCO2) Invasivebloodpressure(P1andP2) Anestheticagents(AGENT) FractionalinspiredO2(FiO2),andendtidalandfractionalinspiredN2O(EtN2OandFiN2O) Temperature(TEMP) ExpressionMR400InstructionsforUseSystemOverview21 Noninvasivebloodpressure(NIBP) Respirationrate(CO2orbellows) Note Depending upon the equipped options, your MR400 may not have all indicated parameters. System Components Beforeuse,familiarizeyourselfwiththeMR400anditscomponents.AcompleteMR400system consistsofthefollowingcomponents:

MR400cart wECGmodule wSpO2module Modulebatterycharger Optional:IP5withorwithoutaprinter Batteriesandotheraccessoriesasneeded Use Model TheMR400isintendedtobeusedtomonitorthevitalsignsofapatientinanMRmagnetroom, asillustratedbelow.ThewECGandwSpO2modulescommunicateviawirelesslinkstosupplythe patientsmeasuredECG,SPO2,andbellowsderivedrespirationsignalstotheMR400.Thegating cableisonlyrequiredforMRItriggeringandsynchronizationbasedonthepatientsECGorSPO2 signals.WhenpairedwithanoptionalIP5,monitoringcapabilitycanbeextendedviawirelesslink toanMRcontrolroom,inductionroom,orrecoveryroomenvironment.Datatransmittedfrom theMR400toanIP5canbeoutputtoanoptionalstripchartprinterortothehospitalinformation system(HIS). 22SystemOverviewExpressionMR400InstructionsforUse MR400 MRI magnet room Gating cable Modules to MR400

(wireless) Patient table MR400 to IP5 (wireless) HIS system IP5 MRI control room Printer USB Ethernet Hospital network Acquisition and Control UseoftheMR400isrestrictedtoonepatientatatime.TheMR400displayspatient measurementsacquiredduringmonitoring.Controlsandsettingsforpatientmonitoringare providedlocallyonthetouchscreenorremotely(forexample,intheMRIcontrolroom)when equippedwiththeIP5,whereconnectionsfortheprinterandthehospitalnetworkarealso available. Synchronization TheMR400willautomaticallyestablishcommunicationwiththewirelessmodules,andIP5(if equipped).However,duetotheusemodel,thedevicescanestablishcommunicationand synchronizepoweronsettingsaccordingtothestartupsequence:

IftheMR400bootsandcommunicatesfirst,thenitssettingswillbereflectedattheIP5. IfanIP5bootsandcommunicatesfirst,thenitssettingswillbereflectedattheMR400. IfusinganIP5,patientidentifiableinformation(nameandIDnumber)willbeavailableafter synchronizationoccurs. ExpressionMR400InstructionsforUseSystemOverview23 WARNINGS WARNINGS The use model specifies one IP5 per MR400 system. If more than one IP5 is present on the MR400 system, there is an increased risk of units within the system not synchronizing and displaying incorrect or corrupted settings. The MR400 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. CAUTION If the monitors settings are adjusted since they were last recalled or stored (manually, or via synchronization if using an IP5), the User Settings key (see page 2-15) will be appended with a plus symbol (+). The symbol will only be removed if the current settings are saved (see page 3-15) or if different settings are recalled (see page 3-26). Always confirm the proper settings for the MR400 and IP5 to ensure expected monitoring functionality. Note See Default Settings (on page 3-7) for information about the systems power-on setup. Device Control Menucommandsthatcontrolparameterfunctionsforpatientmonitoringaresynchronized betweentheMR400andIP5.Commandsthatdonotdirectlycontrolpatientparameters(for example,printerfunctions)willonlyaffecttheIP5.Othercontrolsettingsremainlocalizedtothe IP5andarenotsynchronizedwiththeMR400,includingthealarmaudiooffandalarmaudio pausefunctions,andthevolumesettings;seetheIP5IFUforacompletelisting. 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 portion of the MR400. This will result in the removal of all patient data and displayed information, and a continuous alarm will sound until power to the MR400 is turned off. If this problem persists, contact technical support. 24SystemOverviewExpressionMR400InstructionsforUse Hardware Features Cart DesignedforuseintheMRmagnetroomandthroughouttheMRsuite,theMR400isaself containedmobilepatientmonitoringsystem.TheMR400featuresawheeledcartdesignwith fourlargelockablecastersunderitsaluminumframeandincludesintegratedsystemsfor processing,power,displayandcontrol,asoutlinedbelow. 5 2 1 2 3 4 5 7 8 4 9 10 6 6 1 Display panel (see page 2-6 for details). 2 Guide handles provides the means for positioning the cart; see page 3-2 for details. 3 Patient connection panel (see page 2-7 for details). 4 Accessory hooks provide storage for sampling lines, cables, et cetera. 5 Battery compartments house the main batteries; see page 1-16 details. 6 Casters with wheel locks that, when engaged, prevent movement of the cart. ExpressionMR400InstructionsforUseSystemOverview25 7 Storage basket provides storage for Quadtrodes, cuffs, SPO2 attachments and other small accessories; see page 2-12 for details. 8 Module holders provide storage for the wECG and wSpO2 modules; see page 2-12 for details. 9 Wireless processing unit (WPU) houses the communication, processing and power systems for the MR400. 10 Rear panel houses connections for AC mains power, earth ground, gating, USB port (service use only), (optional) waste gas output, and (optional) O2 sensor. Display Panel ThedisplaypanelincludesatouchscreenLCD(liquidcrystaldisplay),thealarmindicatorsandan audiospeaker.Thedisplaypanelcanbetiltedbackwardorforwardtoachievethebestviewing angleandreduceanyglareonthetouchscreenproducedbyambientlighting. CAUTION Never use the display panel to position the MR400; severe damage or failure can result. Only use the guide handle to position the MR400. If breakage of the display panel glass does occur and you contact the liquid crystal by chance, please wash it from your skin using soap and water. 1 2 3 4 1 2 3 4 Touch screen provides displayed information and control of the MR400, and can be used with gloved fingers. Alarm light provides a visual indication of an alarm condition. Speaker provides all audible indications. USB port provides service-related functions. 26SystemOverviewExpressionMR400InstructionsforUse Patient Connection Panel ThepatientconnectionpanelcontainsthepowerswitchandLED,andinputconnectionsfor variouspatientaccessories. Note The illustration shown below features a composite of all available options. Your MR400 will not have all of these options. 8 7 6 1 2 3 4 5 6 7 8 1 2 3 5 4 NIBP interconnect hose port

(Optional) Loflo CO2 sampling line port

(Optional) Temperature port

(Optional) AGENT sample port

(Optional) AGENT water trap

(Optional) Invasive blood pressure ports (P1 and P2) Power switch (standby switch) is a push-type latching switch that controls power (AC mains or batteries) to the MR400 Power LED indicates the power source and power status of the MR400, as detailed in the table below Power LED Condition / Meaning Color State Power Source None Green Off Steady None (batteries may be installed) Depending upon power source:

Power Switch Off On If AC is present, then AC mains If AC is not present, then batteries ExpressionMR400InstructionsforUseSystemOverview27 Power LED Condition / Meaning Color State Power Source Red Blue Blue Steady Blinking Steady Power fault detected; contact technical support. Batteries are charging Batteries at full charge Power Switch N/A Off Off wECG and wSpO2 Modules ThewECGandwSpO2modulesarebatterypoweredandcommunicatewiththeMR400through abidirectional2.4GHzRFlink,whichisautomaticallyestablishedapproximately30secondsafter powerisappliedtothemodule.Thesewirelessmodulesoperateatadistanceofupto9.1m(30 feet)fromtheMR400cartwhenalldevicesareplacedwithinthesameMRIroomorwithinthe sameshieldedroom. Thenetworkchannelandbatteryindicatorsdenotetheselectednetworkchannelandthe batterystatusforeachwirelessmodule.Aftercommunicationshavebeenestablished,all moduledependentvitalsigninformationwillbedisplayedwithin10secondsontheMR400. WARNING The system use model specifies one wECG module and one wSpO2 module per MR400 system network channel. If more than one type of each module is communicating on the same network channel, then waveform and measurement corruption will occur. 28SystemOverviewExpressionMR400InstructionsforUse wECG Module ThewECGmoduletransmitsmeasuredECGsignalsthroughtheRF linktotheMR400,wheretwoECGsignalscanbedisplayedandare availableforinterfacingwiththeMRsystemcardiacgatinginput. ThemodulealsoreceivesinformationfromtheMR400toperform commandedtasks(forexample,leadviewandfiltermode selections). 1 2 3 1 2 3 4 5 6 7 8 Battery 1 eject button Batteries Battery 2 eject button Battery 1 indicator Battery 2 indicator Network channel indicators (15, in this example) Network selection button ECG lead cable connector 4 5 6 7 8 wECG Module Indicators BatteryindicatorsprovidechargestatusindicationsforeachbatteryusedbythewECGmodule, asdetailedinthetablebelow. Notes A battery time-remaining counter is displayed by the MR400; see page 2-16 for details. For battery replacement details, see page 1-24. wECG Battery Indicator Color None Green Red None Green Red Charge Status Battery not installed in battery bay 1, or the batterys charge is insufficient to power the module Battery installed in battery bay 1 has sufficient charge Battery installed in battery bay 1 has low charge Battery not installed in battery bay 2, or the batterys charge is insufficient to power the module Battery installed in battery bay 2 has sufficient charge Battery installed in battery bay 2 has low charge ExpressionMR400InstructionsforUseSystemOverview29 Networkchannelindicatorilluminatestoprovidethewirelessnetworkchannelindicationand thestatusofthewECGmoduletoMR400communications,asdetailedinthetablebelow. Notes The communication status is also displayed by the MR400; see page 2-16 for details. For network channel selection details, see page 1-29. Network Channel Indicator Channel Selected Network Channel Indicator Channel Selected Channel 1 Channel 2 Channel 3 Channel 4 Channel 5 Channel 6 Channel 7 Channel 8 Channel 9 Channel 10 Network Channel Indicator State Communication Status Steady Flashing Good communication No communication 210SystemOverviewExpressionMR400InstructionsforUse wSpO2 Module ThewSpO2moduletransmitsmeasuredbloodoxygensaturation, plethysmography,peripheralpulsedataandpneumaticrespiration ratevaluesthroughtheRFlinktotheMR400,wheretheprocessed informationcanbedisplayedandoutputforinterfacingtotheMR systempulseperipheralandrespirationgatinginput. 1 2 1 2 3 4 5 6 7 Battery eject button Battery Battery indicator Network channel indicators (15, in this example) Network selection button Pneumatic respiration port; see page 10-2 SPO2 probe connector; see page 1-18 7 3 4 5 6 wSpO2 Module Indicators BatteryindicatorprovideschargestatusindicationsforthewSpO2module,asdetailedinthe tablebelow. Notes A battery time-remaining counter is displayed by the MR400; see page 2-16 for details. For battery replacement details, see page 1-26. wSpO2 Battery Indicator Color None Green Red Charge Status Battery not installed or its charge is insufficient to power the module Battery charge sufficient Battery charge low Networkchannelindicatorilluminatestoprovidethewirelessnetworkchannelselection indicationandthestatusofthewSpO2moduletoMR400communications,asdetailedinthe tablebelow. ExpressionMR400InstructionsforUseSystemOverview211 Notes The communication status is also displayed by the MR400; see page 2-16 for details. For network channel selection details, see page 1-29. Network Channel Indicator Channel Selected Network Channel Indicator Channel Selected Channel 1 Channel 2 Channel 3 Channel 4 Channel 5 Channel 6 Channel 7 Channel 8 Channel 9 Channel 10 Network Channel Indicator State Communication Status Steady Flashing Good communication No communication Storing Modules and Accessories WARNINGS WARNINGS Never store items containing ferrous materials on the cart or in the storage basket. Failure to observe this warning may result in serious injury. To reduce the spread of infection, never store accessories on the cart guide handles. CAUTION When storing or removing the wECG and wSpO2 modules from the module holders, grasp only the module and never pull or apply excessive force or tension to any connected attachment. 212SystemOverviewExpressionMR400InstructionsforUse TostorethewECGmoduleandaconnectedECGleadcable LooptheECGcabletrunkwithfoaminsulatorandsecureitusingthe Velcrostoragestrap(seepage52).Then,placethewECGmodule intoamoduleholderandallowtheECGleadcabletodrape. WARNING Do not use the Velcro storage strap to loop the ECG lead cable during MR scanning; otherwise, there is a risk of cable heating and possibly skin burns. CAUTION Failure to loop the Velcro storage strap on the ECG cable trunk may result in damage to the lead cable due to contact with the floor. TostorethewSpO2moduleandaconnectedprobe PlacethewSpO2moduleintoamoduleholderandallowtheSPO2 probetodrape. Tostoresmallaccessories,samplelinesandthetemperaturesensor Usetheremovablestoragebaskettoholdsmallaccessories(Quadtrodes,SPO2clipsand grips,etcetera).Toremovethestoragebasketfromthecart,graspthebasketandlift. Usetheaccessoryhookstohangloopedsamplelines,thetemperaturesensor,etcetera. CAUTIONS Do not place more than 2.2 kg (5 pounds) of combined weight of items in the storage basket, module holders and accessory hooks. Never stack items onto or drape objects over the guide handle. Displayed Information and Controls ThedisplayedinformationandcontrolsfortheMR400aregroupedonthetouchscreen accordingtofunction. Note The example below depicts information displayed by a fully-equipped MR400. Information displayed by the MR400 will vary according to the equipped options and activated parameters. If a parameter (or an ECG trace) has been turned off, its portion of the display will be blank. To turn a parameter on or off, use Parameters in the Monitor Setup menu; see page 3-18 for details. ExpressionMR400InstructionsforUseSystemOverview213 5 4 1 2 3 1 2 3 4 5 Information bar Soft keypad Status information pane Vital sign boxes Vital sign traces Information Bar Theinformationbarprovidesgeneraluse,vitalsigndetectionandpatientinformation. 1 2 3 4 5 6 7 8 1 2 3 4 Set Time indication, and when pressed accesses the date; see page 3-13. Alarm sound state indication; see page 4-4. Heart beat detection indication (and provides a detection tone) according to the HR Tone Source setting; see page 3-21. Respiration detection indication when CO2-derived respiration is on and within specified limits, flashing at a frequency that matches the current breath rate. 214SystemOverviewExpressionMR400InstructionsforUse 5 6 7 8 Alarm Light setting indication; see 4-20. Patient information area, which displays the patients name and identifier (ID) when available from an IP5. Patient Type key and the current patient type setting indication;

and, when pressed, accesses the Patient Type menu (see page 3-

11). User Settings key and user settings file name indication (where the plus symbol [+] indicates that changes have occurred); and, when pressed, allows you to select a factory or a stored user setup

(see Edit User Settings on page 3-15). Soft Keypad Thesoftkeypadprovidesimmediateaccesstofrequentlyusedmenusandfunctions. 13 12 11 10 9 8 1 2 3 4 5 6 7 1 Main Screen key returns the MR400 to normal mode, closing any open menu, option or dialog box 2 Print key controls the remote print function and indicates the current state of the printer 3 Trends key accesses the Tabular Trends menu 4 NIBP Start/Stop key starts or stops an NIBP measurement 5 ECG Filter key accesses the ECG Filter Mode options ExpressionMR400InstructionsforUseSystemOverview215 6 Suspend key places the MR400 in suspend mode 7 Audio Pause key temporarily deactivates alarms 8 Alarm key acknowledges an active alarm 9 1-Touch Alarms key sets all alarm limits according to preset calculation values 10 NIBP Interval key accesses the automatic measurement Interval options 11 Clear Trends key clears stored trend data 12 Zero All key zeros all active invasive blood pressure channels 13 Setup key accesses the Monitor Setup, Printer, and Alarms menus Status Information Pane ThestatusinformationpaneprovidesindicationsfortheMR400andwirelessdevices:

Communicationandpowerindicationswillbedisplayedwithin2seconds. 5 1 4 3 2 1 2 Monitor network icon, which indicates the selected wireless network channel (1, in this example) and, when pressed, allows you to select the channel used by the MR400; see Setting the Wireless Network Channel of the Cart on page 1-27 for details. Indicates the battery time-remaining (given in an hours:minutes format) until power will be exhausted for the wSPO2 module; also, indicates that the wSPO2 modules communication with the MR400 is good. 216SystemOverviewExpressionMR400InstructionsforUse 3 4 5 Indicates the battery time-remaining (given in an hours:minutes format) until power will be exhausted for the wECG module; also, indicates that the wECG modules communication with the MR400 is good. For detailed battery information regarding the wECG module batteries, see Status Information Panel on page 2-18. Indicates the current power type used by the MR400 (AC power in this example). Indicates that an IP5 is communicating with the MR400. Powersourcechangeofstateindicationsaredisplayed. 1 2 2 1 Indicates a low battery condition and the approximate time (given in an hours:minutes format) until power will be exhausted for a module battery (wSpO2 in this example); also, indicates that the modules communication with the MR400 is good. WARNING A red battery symbol indicates that the module batteries have fallen below the required operational output and module shutdown with loss of monitoring will occur. Immediately replace the module batteries to avoid a loss in monitoring. Indicates that the cart batteries are the current power type used by the MR400 and the approximate time (given in an hours:minutes format) until power will be exhausted. WARNING A red battery symbol indicates that the main batteries in the MR400 have fallen below the required operational output and system shutdown with loss of monitoring will occur. Immediately locate an AC outlet and connect the MR400 to avoid a loss in monitoring. ExpressionMR400InstructionsforUseSystemOverview217 Indicationsareprovidedforalossofcommunication,whichisindicatedwithin2seconds, andanodatacondition(seepage220)willbedisplayedwithin10secondsforallvitalsign informationmissingduetoanoncommunicatingwirelessmodule. 2 1 1 1 2 Indicates that no communication is occurring between the MR400 and a wireless module (wECG in this example), or between the MR400 and the IP5. Indicates a status warning when a communication error between the MR400 and a wireless module, or between the MR400 and an IP5 is detected. Status Information Panel Thestatusinformationpanelprovideswirelesscommunicationandpowerdetails,includingthe chargelevelofallconnectedbatteries. Toopenthestatusinformationpanel Selectthetitlearea(1,below)onthestatusinformationpane. 1 218SystemOverviewExpressionMR400InstructionsforUse Vital Sign Boxes Vitalsign(VS)boxesareuniquelycoloredandlabeledgraphicframesthatcontainthenumeric measurementsandcurrentalarmlimitssettingsforeachmonitoredparameter.Trending indications(arrows)areavailableforeachmonitoredvitalsign,exceptNIBP.Inaddition,theVS boxes(exceptAGENTandGAS)accesstheassociatedparametersmenu. 1 2 3 4 5 10 9 8 7 6 1 ECG VS box provides electrocardiogram and heart rate measurements. 2 SPO2 VS box provides blood oxygen saturation/pulse oximetry and the heart rate measurements from pulse detection. 3 CO2 VS box provides CO2 measurements and can also provide respiration measurements. 4 P1 VS box provides invasive blood pressure measurements for channel 1 when equipped with the invasive blood pressure option. 5 P2 VS box provides invasive blood pressure measurements for channel 2 when equipped with the invasive blood pressure option. 6 GAS VS box provides the total MAC value, O2 and N2O measurements when equipped with the AGENT option. 7 AGENT VS box provides anesthetic agent measurements when equipped with the AGENT option. 8 RESP VS box provides respiration rate measurements from CO2 or the bellows accessory. ExpressionMR400InstructionsforUseSystemOverview219 9 TEMP VS box provides temperature measurements when equipped with the temperature option. 10 NIBP VS box provides non-invasive blood pressure measurements. No Data Indications Undercertainconditions,nowaveformsandoneormorevitalsignnumericsmaydisplaythree dashes(),whichindicatesthatnodataisavailablefortheparameter(s). Dependinguponthecauseofthismissingdata,analarmconditionmaybegenerated. Nodataindicationsthatmaynotgenerateanalarm Ifamoduleoranothermeasurementdevicewasjustturnedonorappliedtothepatient, allowafewsecondsforcommunicationtobeestablished,orforanyrequiredwarmup periodtooccur. Thefirstreadinghasnotyetbeentakenortheparameterisinastartupcondition(for example,theAGENTorCO2monitoringhardwaremaybewarmingup). Themeasurementvaluesaredistortedorthesignalisinadequate(forexample,the concentrationofgasesmaybebelowtheminimumvolumepercentagedetectable). Suspendmodewasjustexited. Nodataindicationsthatmaygenerateanalarm Parameterdatawaspresentbutcannolongerbeproduced(forexample,anattachment appliedtoapatientmayhavebecomedisconnected). Thehardwareassociatedwithaparameterhasexperiencedaproblemorfailurethat preventsproperoperation. 220SystemOverviewExpressionMR400InstructionsforUse Other Data Indications TheOverStateIndication(OVR) Ifthevalueofthenumericdataiteminthevitalsignboxisgreaterthanthehighestvalue specifiedfortheitem,OVRwillbedisplayedinanalarmconditioninplaceofthenumeric.Seethe tableonpage425formeasurementrangeanddeclarationinformation. TheUnderStateIndication(UND) Ifthevalueofthenumericdataiteminthevitalsignboxislessthanthelowestvaluespecifiedfor theitem,UNDwillbedisplayedinplaceofthenumericinanalarmcondition.Seethetableon page425formeasurementrangeanddeclarationinformation. Vital Sign Traces and System Message Area Vitalsign(VS)tracesareuniquelycoloredwaveformsfortheECG,SPO2,CO2andinvasiveblood pressureparameters.Thesetracesarefixedacrossthescreen,adjustableandupdatedfromleft torightwithanerasebar.ThewaveformcolorcorrespondstothecoloroftheassociatedVSbox numericdataforthatparameter.Uptosixwaveformscanbedisplayed,butifaparameteris turnedoffthenthattraceportionofthescreenandVSboxwillbeblank. Systemmessagesandsomealarmflags,asdetailedthroughoutthismanual,aredisplayedinthe centerandtopportionsofthevitalsigntracesarea.Multiplesystemmessagesoralarmflagswill bestackedinthisarea. 1 2 3 4 5 6 Trace A displayed as the ECG 1 waveform depending upon the selected source Trace B displayed as the ECG 2 waveform when two ECG sources are selected Trace C displays the SpO2 waveform 7 1 2 3 ExpressionMR400InstructionsforUseSystemOverview221 4 5 6 7 Trace D displays the CO2 respiration waveform (breath rate) Trace E displays invasive blood pressure, channel 1 (P1) waveform Trace F displays invasive blood pressure, channel 2 (P2) waveform System message area displays system messages and alarm flags;

see chapter 4. Navigation and Operation EverythingneededtonavigateandoperatetheMR400canbeperformedbyselectinganactive elementonthetouchscreen(includingsoftkeysandbuttons,icons,menus,VSboxesandalarm limitssettings).Whenanactiveelementistouchedwithafingerorapassiveobject(suchasa stylus),theMR400willhighlightthatoptionoritem,produceatoneandenacttheselection. CAUTION Never apply unnecessary pressure or use sharp objects on the touch screen as damage or failure can result. If breakage of the display panel glass does occur and you contact the liquid crystal by chance, please wash it from your skin using soap and water. Notes Simultaneously touching two or more screen areas may produce unpredictable results and is not recommended. The design of the MR400 allows access to the same menus in different ways. The MR400 monitors all application processes. If a software process or an application monitoring failure is detected, then an audible alarm will sound and all visual information will be removed from the display. To restore normal operation, you must turn the power switch off and then on. If the problem persists, contact technical support. Specialized Control Buttons and Keys Inadditiontothecontrolmethodsdescribedabove,somemenus,optionsanditemsinclude specializedsoftkeysandbuttonsthatcontrolmenus,settingsandentries:

Todecrementanumericvalue,select Toincrementanumericvalue,select

. 222SystemOverviewExpressionMR400InstructionsforUse Tocloseamenuoritem,select Toclearanentryfield,select

. Tosaveentereddataandcloseamenuoritem,select

. Toenterdata,savechangesandcloseamenuoritem,select

. Default Setting Indications Thedefaultsettingofamenuappearsasthehighlighteditem,orastheitemwithanasteriskina menu. System Messages Systemmessagesaredisplayedtoinformyouaboutacurrentoperationorcondition,as discussedthroughoutthismanual.AlsoseeSystemStatusIndicationsonpage431. Password Protection Entryofasixdigitpasswordisrequiredforaccesstosome menus,especiallyservicerelatedmenus.(Contacttechnical supportforinformation.) WhenEnterPassword:isdisplayed,usethekeypadtoenterthe correctpasswordtocontinuetothedesiredmenu. Modes of Operation TheMR400hasthreeoperatingmodes:normal,suspend,andsimulation. Normal Mode Normalmodeisthestandardoperatingmode.Innormalmodetherearenoopenmenusor highlightedvitalsignboxes;thesystemisreadyformonitoring. ExpressionMR400InstructionsforUseSystemOverview223 Suspend Mode Toenternormalmode PresstheMainScreenkey. AnyopenmenuwillcloseandanyhighlightedVSboxwillbedeselected(thatis,thenormalscreen willbedisplayed).Seepage214foranillustration. WARNING Suspend mode should never be used to silence alarms or when a patient is being actively monitored as a delay in treatment and possible patient injury could result. Suspendmodesupportspatientclinicianinteractionwithoutnuisancealarms,whichisuseful whereminimaluserinteractionisrequired(forexample,whileapatientisnotbeingmonitored, duringtransitionswhenremovingthemonitorfromonepatientandconnectingitonanother,or ifcertainadjustmentsarebeingmadetothedeviceorotherequipment). Insuspendmode,currentpatientinformationisprovided,butwiththefollowingoperational exceptions:

Audiblealarmsaredisabled;

ActiveautomaticNIBPmeasurementsaresuspended;

DefaultinflationpressuresareusedforallmanualNIBPreadings;and, IfequippedwithanIP5andprinter,automaticprintoutswillnotbegenerated. Toentersuspendmode PresstheSuspendkey. Suspendedwillbedisplayedatthecenterofthescreen.Seepage220foranillustration. Toexitsuspendmode PresstheSuspendkey. Simulation Mode Simulationmode,apasswordprotectedfunction,supportstrainingandtestingneedsby displayinginternallygenerateddataforvitalsignwaveforms,numericvaluesandstatuses.In simulationmode,allpatientmonitoringisdiscontinued.Seepage329formenudetails. 224SystemOverviewExpressionMR400InstructionsforUse CHAPTER 3 Getting Started Initialsetupisimportanttoachieveexpectedresultsandseamlessoperation. WARNINGS Perform operational verification prior to use. If the MR400 fails to function properly, remove it from use and contact technical support personnel. Do not allow the patient to move while the MR400 is being used as over-activity may result in prolonged or inaccurate readings. Position of the accessories may affect measurement accuracy. Always consult a physician for interpretation of measurements provided by the MR400. Do not operate the MR400 outside the specifications indicated in Appendix A as it will cause inaccurate results. 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 MR400 on page 3-2 for details. Defibrillator and Electrosurgical Use TheMR400hasadefibrillationproofdegreeofprotectionthatallowsapatienttobedefibrillated whileconnectedtothewECGmoduleandleads.Whenusingadefibrillator,followallprecautions relatedtoboththeMR400andthedefibrillatorequipment.Duringadefibrillationprocedure,the ECGwaveformwillsaturatethenrecoverinlessthan5secondsinaccordancewithAAMI/ANSI EC13andIEC60601227. ExpressionMR400InstructionsforUseGettingStarted31 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. This equipment does not provide protection against burning of the patient. The MR400 can be used in the presence of defibrillators or electrosurgery units, provided the equipment being used is in good working order, meets 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. Electrosurgical unit overloads may cause damage to this device. To minimize risk of damage to the MR400 during defibrillation, use only the manufacturers specified accessories and supplies. This equipment does not meet electrosurgical interference suppression (ESIS) requirements as stated in EC13, sub clause 4.2.9.14, as the ECG trace will temporarily disappear from the display during cut or coagulation bursts. 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 MR400 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). Positioning the MR400 Duringuse,stationthecartatasafemonitoringdistanceintheMR magnetroomthenpressdownoneachwheellocktoengageit.(When thecartneedstobemoved,raiseeachwheellockbeforeproceeding). UsetheguidehandletomoveandpositiontheMR400.Alwaysplacethe MR400sothatyourviewofthescreenandalarmlightwillremainunobstructedduringuse. CAUTION Never lean against or apply excessive force to the guide handle. 32 GettingStartedExpressionMR400InstructionsforUse WhenpositioningtheMR400foruse,observethefollowingwarningandcautions:

Warning WARNING

.The MR400 shall meet its full function and performance specifications when positioned in the MR room of a 3T magnet, up to the 5000 gauss line, 4W/kg SAR, and 7.2 T B1rms in all orientations. Always secure the MR400s wheel locks when the unit is placed within the MR system room. Failure to properly position the MR400 and its accessories in the MR system room will result in system or accessory failure, and possible patient or user injury. CAUTIONS If the MR400 rolls to the face of the MR system due to magnetically induced pull force, do not attempt to dislodge the MR400 by pulling from the display panel or guide handle;

instead, dislodge the MR400 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. Position the MR400 in a manner which does not block access to the device or wall plug connectors. Field strength variations in a particular MR system room (which may be due to active shielding technology, manufacturer variability, future enhancements, etc.) can make distinguishing the 5,000 gauss level (as measured from the center line of the MR bore) difficult. These variations may require moving the MR400 away from the MR system if system abnormalities or malfunctions are observed. Prior to clinical use, ensure that the allowable distance of the MR400 from the MR system is maintained for proper operation. Operating the MR400 SAFETYAWARENESS Warning WARNING Do not start up the product unless you and all other users present have read, fully understood and know all the safety information and emergency procedures given in the Safety section of this Instructions for Use. Operation of the product without having read, understood and knowing ALL the safety information and procedures in the SAFETY section could lead to fatal or other serious personal injury. It could also lead to clinical mis-diagnosis or clinical mistreatment. ExpressionMR400InstructionsforUseGettingStarted33 FollowthestepsbelowwhenoperatingtheMR400. Step Action 1 2 Pressthepowerswitch

;seepage27forthelocation. EnsurethatthewECGandwSpO2modules(andIP5,ifequipped) haveestablishedgoodcommunications,andthatsufficientpower existsfortheMR400andthewirelessmodules.Alsoverifyproper operationofthepatientparameters. SeeSystemPowerupandCommunicationsVerification,below. System Power-up and Communications Verification Warning WARNING Always perform operational verification prior to use and during monitoring by ensuring proper communications between the MR400, the wireless modules and 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. TheMR400reachesanoperationalstatewithin60secondsafterpowerupandattainsfull measurementaccuracyaccordingtotheequippedoptions:

Afterapproximately2minuteswhenequippedwiththeCO2LoFlooption Afterapproximately10minutesifequippedwiththeAGENToption. Whenanydisplayedwarmupmessagedisappears,theMR400isreadyforuse. ToapplypowertotheMR400andverifysystemcommunications Step 1 2 3 Action EnsurethatbatteriesareinstalledinthewECGmodule(seepage1 24). CheckthebatteryindicatorsonthewECGmoduletoensurethat enoughchargeexistsinatleastoneoftheinstalledbatteries:

Greenbatteryindicator=Chargesufficient;proceedtostep4. Redbatteryindicator=Chargelow;proceedtostep3. Seepage29fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) Accordingtotheredbatteryindicator(s)presentonthewECG module,insertachargedmodulebatteryintothecorresponding batterybay(s)andthenrecheckthebatteryindicator(s)toensurea sufficientchargebeforeproceeding;seepage124. 34 GettingStartedExpressionMR400InstructionsforUse Step 4 5 6 7 8 9 10 11 12 13 Action EnsurethatbatteriesareinstalledinthewSpO2module(seepage 126). CheckthebatteryindicatoronthewSpO2moduletoensurethat enoughchargeexists:

Greenbatteryindicator=Chargesufficient;proceedtostep7. Redbatteryindicator=Chargelow;proceedtostep6. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) InsertachargedmodulebatteryintothewSpO2moduleandthen recheckthebatteryindicatortoensureasufficientchargebefore proceeding;seepage126. WiththecartbatteriesinstalledandwiththeMR400connectedto ACmainspower(seepage120),pressthepowerswitch.Allowthe MR400toinitialize.

(Optional)Ifequipped,turnontheIP5. CheckthenetworkchannelindicatoronthewECGmoduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep11. Flashing=Nocommunication;proceedtostep10. Seepage29fordetails.(Also,youcanreferencethestatus informationpane;seepage216.)AninoperativeECGparameteror wECGmoduleisindicatedbyabsenceofanECGwaveformanda simultaneousLeadFailalarm. EnsurethatthewECGmoduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129. CheckthenetworkchannelindicatoronthewSpO2moduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep13. Flashing=Nocommunication;proceedtostep12. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) EnsurethatthewSpO2moduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129.

(Optional)IfequippedwithanIP5,ensurethatthewireless networkchanneloftheIP5isthesameasthewirelessnetwork channelsettingoftheMR400;seetheIP5IFUfordetails. ExpressionMR400InstructionsforUseGettingStarted35 Step 14 15 Action

(Optional)IfequippedwithanIP5,ensuregoodcommunication betweentheMR400andtheIP5bycheckingthestatusinformation pane(seepage216). Ensureproperoperationofeachpatientparameterandalarms. Refertoappropriatechaptersinthismanual. CAUTION If power to the wireless device with established communications is lost or removed, its network connection will be dropped. Cart Power-down ToturnpowerofftotheMR400,pressthenholdthepowerswitchforapproximately2seconds. NOTE For instructions on the complete removal of power to the MR400, see page 14-2. Wireless Module Power-down Toturnpowerofftoawirelessmodule,removethebattery(wSpO2module)orbatteries(wECG module). Monitor Initialization Afterpowerupanduntiltheinitializationprocesscompletes,thetouchscreenmayremain blank.Afterinitializationcompletes,theMR400canbeginmonitoringfunctionsfromaninitial factorydefaultstateorfromapreconfiguredstate,dependinguponthewaythestored configurationsandpatientdataareprogrammedforstartup. Visuallycheckingthepatientandconfirmingchangingmeasurementsagainstothervitalsigns shouldbestandardroutinesduringuse. 36 GettingStartedExpressionMR400InstructionsforUse Warning WARNING When using an IP5, make sure that the content of the User Settings option matches that of the MR400 option, and that the same option is selected as the default setup on both systems

(see page 3-26). This is important because the device first booted will determine the power-

on settings of the system (that is, the MR400 and optional IP5). Viewing the Displayed Information ThehighresolutiontouchscreenLCDfacilitateswaveformanalysisandvitalsignnumeric interpretation,withimportantdisplayelementswhicharedesignedtobelegibleataminimum distanceof1meterbyuserswithavisualacuityof20/20.WhenusingtheMR400,alwaysadjust theviewingangleofthetouchscreentocomplementyourlineofsightandalwaysensurethat yourviewremainsunobstructed. CAUTION Never apply unnecessary force to the touch screen as it can result in damage or failure. NOTE To change the language displayed by the MR400, see System Config page 3-30. Default Settings Atpowerup,theMR400willautomaticallysetallmonitorsetupoptionsasdeterminedbythe defaultselectionintheEditUserSettingsmenu.Bydefault,thefactorysettingsareusedwhen thesystemisturnedon,unlessacustomsettinghasbeenselected.Also,asdiscussedearlier,due totheusemodel,thepowerondefaultsettingsfortheMR400candependupona communicatingIP5andthestartupsequenceofthedevices. Default Setting Indications TheUserSettingskeyindicatesthecurrentdefaultsetup(wheretheplussymbol[+]indicates thatchangeshaveoccurred)anditallowsyoutoselectafactoryorastoredusersetup;seepage 214. Whenamenuisdisplayed,thedefaultwillbehighlightedorwillappearwithanasterisk.Forthe factorydefaultsettings,seethemenulistingsthroughoutthisIFU. ExpressionMR400InstructionsforUseGettingStarted37 User Settings IntheEditUserSettingsmenu,uptotencustomizedusersettingscanbesavedandonecanbe selectedforuseasthedefaultatpoweron.Usersettingscanincludeanyofthefollowingmenu options:

Alarms Minimumandmaximumvalues Autosetpercentage Alarmsoundlevel ExtremeHRalarmvalues Desatalarmvalues SystemSetups ECG Selectedlead Scalesetting Tracespeed Filtermode QRStoneon/off Heartratesource PediatricECGon/off ExtremeHRalarmfunctionsetting SpO2 Size Desatalarmfunctionsettings CO2 Size Grids CO2(RESP) Apneaalarmfunctionsettings NIBP Manual OfforAuto Automatictimeinterval Trendgraphs Timebases Scales PrintSetups OfforAuto Tracedelay Printerspeed Selectedtraces 38 GettingStartedExpressionMR400InstructionsforUse NOTE When a setting is changed in an active user settings file, a plus sign (+) will appear on the User Settings key. And when edits have been made to an existing user settings file, a warning box and setting change list will appear, prompting you to accept or cancel the changes to proceed. SoftKeyboardAddNew Namescanbeassignedtoyourusersettingsfilesusingthesoftkeyboardthatisdisplayedwhen theAddNewoptionisselected;seepage315.Thissoftkeyboard(seeillustrationbelow) functionslikestandardQWERTYkeyboard,butwithadditionalfeaturesfordatacapturesand defaultsettingselection. 4 3 2 1 1 2 3 4 Save & Close button assigns the captured settings to the entered file name then saves the file in memory and closes the menu. Capture Settings button saves the current settings data of the MR400. Set To Default button selects the settings of the current entry for use following power-up of the MR400. Entry field displays the currently entered file name for the captured user settings. SoftKeyboardEditExisting Existingusersettingsfilescanbeeditedusingthesoftkeyboardthatisdisplayedwhenastored fileisselected;seepage315.Thefilenameanddatacontentscanbechanged,andthedefault settingcanbeupdated.Theillustrationbelowhighlightstheseadditionalfilemanagement featuresofthesoftkeyboard. ExpressionMR400InstructionsforUseGettingStarted39 2 1 1 2 Remove as Default button removes the file as the default user settings file Delete Settings button deletes the file. Initial Alarm Indications Afterpowerupandimmediatelyfollowingtherecallofastoredsetup,theMR400providesan indicationofthealarmvolumebysoundingthealarmtoneatitscurrentlyadjustedsettingfor5 secondsanddisplayingCheckAlarmVolume. Afterpowerup,theinitialalarmstateispausedandthen,followingawaitperiodof120seconds, armedbecomesthenormalalarmstate(asindicatedbythedisplayedsymbol,showninthetable below):

Displayed Symbol Alarm Sound State Alarm audio armed Alarm audio paused Alarm audio off Inthearmedstate:

Analarmwillsoundwhileanalarmconditionexists,providedthatanyprealarmwait periodhasexpiredandthealarmaudioarmedsymbolisdisplayed. 310 GettingStartedExpressionMR400InstructionsforUse Alarmflagsrelatedtootheralarmsoundstateswillberemovedfromthedisplay. Analarmconditionnotpreviouslyplacedinanaudiooffstatewillcausethealarmto sound. Selecting the Patient Type 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 the Patient Type (above) to ensure the best possible and most timely measurement acquisitions. ExpressionMR400InstructionsforUseGettingStarted311 Regardlessofthedefinition,eachagencyrecognizesthatthepatienttypedescriptionscanbe arbitraryandthatthefollowingpatientfactorsaremoreaccurateindeterminingtheappropriate methodofpatientmonitoringandtreatment:

Weight Bodysize Limbcircumference Physiologicaldevelopment Neurologicaldevelopment Neuromuscularcoordination Accordingly,theMR400usesseveraloperationalparameters,includingcuffinflationpressure andpulsesensitivity,thatvarydependingontheselectedpatienttype.(Alwaysreferto informationaboutthecorrespondingparameterforotherpossibleconsiderationswhen determiningthepatienttype.) ThePatientTypekeyallowsyoutosettheMR400forthetypeofpatienttobemonitored. ToopenthePatientTypemenu PressthePatientTypekey. Patient Type menu Patient Type key Thefollowingpatienttypesareavailable:

Adult(Default) Pediatric 312 GettingStartedExpressionMR400InstructionsforUse Neo(whenselected,PediatricECGwillalsobesettoOn) NOTE Changing the Patient Type causes the alarm to sound, Change NIBP Cuff to be displayed for 30 seconds, the initial cuff inflation to be reset to the initial pressure for the patient type selected, NIBP > Auto Mode to be set to off, and the alarm limit settings to revert to the default values24). Toselectthepatienttype Step 1 Action PressthePatientTypekey.(Thecurrentsettingisdisplayed.) ThePatientTypemenuappears.Thecurrentsettingishighlighted. SelectthePatientType:

2 Adult Pediatric Neo Thesettingisentered. Setup Menus PressingtheSetupkeywilldisplaytheMonitor,Printer,and Alarmskeys. 1 2 3 4 Setup key Monitor key Printer key Alarms key TheMonitor,Printer,andAlarmskeysopenassociated menusforsetupandcontrol,including:

Savingandrecallingsetupconfigurations Controllingparameters Adjustingsounds Switchingpatienttypes Settingtimeanddate 1 2 3 4 ExpressionMR400InstructionsforUseGettingStarted313 Settingsweepspeeds ControllingECGmodes Controllingalarms Controllingremoteprinting 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. NOTE Grayed out items in the menu system, indicate features or options that are inaccessible due to current settings, or that are not configured or installed. Monitor Setup Menu TheMonitorSetupmenuallowsyoutoconfiguretheMR400forpatientmonitoring. ToopentheMonitorSetupmenu PresstheSetupkeyandthentheMonitorkey. Monitor Setup menu Setup key Monitor key 314 GettingStartedExpressionMR400InstructionsforUse ThefollowingMonitorSetupmenuitemsareavailable:

Edit User Settings Parameters Sound Adjust Set Time & Date Sweep Speed Resp Speed Service(Bio-Med) TochangesettingsintheMonitorSetupmenu Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. Selectanyofthefollowingmenuitems:

EditUserSettings Parameters SoundAdjust SetTime&Date SweepSpeed RespSpeed Service(BioMed) Theselectedmenuappears.Currentsettingsaredisplayed. Selectthedesiredmenuitem. Thecurrentsettingishighlighted. Selectthedesiredsubmenuorsettingfromthemenuoptions. Thesettingisentered. Tochangeothersettings,repeatsteps2,3and4. 2 3 4 5 Edit User Settings Allowsyoutocapture,storeandmanagemultipleusersetups,andtoselectanoperationalor powerupdefaultsetup.Abackupandrestoreselectionalsoallowsyoutosavetheseuser settingstoanexternaldevice. ToopentheEditUserSettingsmenu ExpressionMR400InstructionsforUseGettingStarted315 PresstheSetupkeyandthentheMonitor key.OntheMonitorSetupmenu,selectEdit UserSettings. 1 2 3 Factory Add New Backup/Restore 1 2 3 Thefollowingoptionsareavailable:

Factoryrecallsthefactorysettings frommemory,whichcannotbemodified.(Default) AddNewallowsyoutoassignafilename,selectadefaultsetting,andstoreacurrent setupinthememory(uptotensetupscanbestored);seepage37formoreinformation. Backup/RestoreallowsyoutobackupandrestoresettingsusingaUSBflashdrive;seethe servicemanual(REF989803181911)fordetails. Toaddandsavenewusersettings Step 1 2 3 4 5 6 Action SetuptheMR400fortheconfigurationtowhichthesesettingswill pertain. PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectEditUserSettings. TheEditUserSettingsmenuappears. SelectAddNew. Thesoftkeyboardappears. Enterauniquefilename(ofuptotwentycharacters)fortheuser settingsusingthesoftkeyboard. PresstheCaptureSettingsbuttontoenterthecurrentsetupdata. 316 GettingStartedExpressionMR400InstructionsforUse Step 7 Action Ifdesired,presstheSettoDefaultbuttontosavethecurrentfileas thedefaultsetupforuseatpowerup. Warning WARNING If you choose to boot the device from a user settings file, confirm that alarm presets are appropriate for the patient prior to monitoring. Failure to do so may cause false or missed alarm conditions. 8 PresstheSave&Closebuttontosavethecurrentsetupandexit themenu. Awarningboxwillappear,promptingyoutoacceptthechanges:

presstheAcceptbuttontosavethecurrentsettings,orpressthe Cancelbuttontorejectthechanges. Toeditsavedusersettings Step 1 Action ConfiguretheMR400forthedesiredsettings. 2 3 4 5 OntheMonitorSetupmenu,selectEditUserSettings. Selectthefilenamethatyouwanttochange. PresstheCaptureSettingsbuttontochangetheusersetuptothe currentsettings. PresstheSave&Closebuttontosavethecurrentsetup. Awarningboxwillappear,promptingyoutoacceptthechanges pressAccepttosavethecurrentsettingsorpressCanceltoreject thechanges. Todeletesavedusersettings Step 1 Action OntheMonitorSetupmenu,selectEditUserSettings. 2 Selectthefilenamethatyouwantdelete. ExpressionMR400InstructionsforUseGettingStarted317 Step 3 Action PresstheDeleteSettingskey. 4 PresstheSave&Closebuttontosavethecurrentsetup. Awarningboxwillappear,promptingyoutoacceptthechanges pressAccepttosavethecurrentsettingsorpressCanceltoreject thechanges. Parameters Controlsmonitoringfunctions,asindicatedbytheabsenceorpresenceoftheVSboxforthe parameter,exceptECG(seebelow). NOTE Some parameters require optional equipment that may not be enabled or present on your system;

see System Config for details. ToopentheParametersmenu PresstheSetupkeyandthentheMonitor key.OntheMonitorSetupmenu,select Parameters. 1 2 3 4 5 6 7 8 9 ECG NIBP P1 P2 SPO2 CO2 RESP TEMP AGENT 1 2 3 4 5 6 7 8 9 Thefollowingparametersareavailable:

ECGallowselectrocardiogrammonitoring:

OffturnsofftheECGparameter.(Heartrate(HR)willremainintheVSbox,allowingit tobedisplayedfromanothersourceorifHRSourceissettoAuto.) 318 GettingStartedExpressionMR400InstructionsforUse OnturnsontheECGparameter.(Default) NIBPallowsnoninvasivebloodpressuremonitoring(doesnothaveanassociated waveform):

OffturnsofftheNIBPparameter. OnturnsontheNIBPparameter.(Default) P1allowsinvasivebloodpressuremonitoring:

OffturnsofftheP1parameter.(Default) OnturnsontheP1parameter. P2allowsinvasivebloodpressuremonitoring:

OffturnsofftheP2parameter.(Default) OnturnsontheP2parameter. SPO2allowsoxygensaturationofarterialbloodmonitoring:

OffturnsofftheSPO2parameter. OnturnsontheSPO2parameter.(Default) CO2allowsCO2andCO2derivedrespirationratemonitoring:

OffturnsofftheCO2parameter.(Default) OnturnsontheCO2parameter. NOTE If CO2 is turned Off, AGENT and GAS will also be deactivated. RESPallowsrespirationratemonitoringusingthebellows(doesnothaveanassociated waveform):

Offturnsoffthebellowsderivedrespirationparameter.(Default) Onturnsonthebellowsderivedrespirationparameter. NOTE If CO2-derived respiration is on, then RESP will not be selectable. To use bellows respiration, select BEL in the RESP menu; see page 10-5. TEMPallowstemperaturemonitoring(doesnothaveanassociatedwaveform):

Offturnsoffthetemperatureparameter.(Default) Onturnsonthetemperatureparameter. ExpressionMR400InstructionsforUseGettingStarted319 AGENTallowsanestheticagentandgasmonitoring(butdoesnothaveanassociated waveform),andCO2andCO2derivedrespirationratemonitoring:

OffturnsofftheAGENTparameter.(Default) OnturnsontheAGENTparameter. NOTE When AGENT is turned on, CO2 will also be activated, including GAS; however, if AGENT is then turned Off, CO2 will remain active. Tocontrolparameters Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectParameters. TheParametersmenuappears.Currentsettingsaredisplayed. Locatetheparameterthatyouwanttocontrolthenselectthe desiredsetting:

Off On Thesettingisentered.Tochangeothersettings,repeatstep3. Sound Adjust Controlsalarm,heartrateandtouchscreentones,andthevolumesettingsforthesounds generatedbytheMR400. 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 MR400, always ensure that the alarm sound can be heard above the ambient noise level; otherwise, treatment of the patient could be delayed. ToopentheSoundAdjustmenu 320 GettingStartedExpressionMR400InstructionsforUse PresstheSetupkeyandthentheMonitor key.OntheMonitorSetupmenu,select SoundAdjust. 1 2 3 4 5 6 Alarms HR Tone Source Alarm Volume Pulse Volume Click Tone Click Volume 1 2 3 4 5 6 Thefollowingmenuitemsareavailable:

Alarmscontrolsthealarmsound(identicaltoandinteractivewithAlarmSoundinthe Alarmsmenu):

Offturnsoffthealarmsound,asindicatedbythealarmaudiooffsymbol(seepage4 4).(Onlythealarmsoundwillbedisabled;visualalarmindicationswillcontinue.) Onturnsonthealarmsound,asindicatedbythealarmaudioarmedsymbol(see page44).(Default) HRToneSourcesetsthesourceusedfortheheartratetone(identicaltoandinteractive withsameoptionintheECGmenuandSPO2menu):

Offremovestheheartbeatdetectedsymbolfromthedisplayandsoundsnopulse tone.(Default) QRSprovidestheheartbeatdetectedsymbolandatonetriggeredbytheQRS detectionfromtheECGvitalsign. SPO2providestheheartbeatdetectedsymbolandatonemodulatedbytheSPO2 vitalsign,wherethelowertheSPO2value,thelowerthepitch. AlarmVolumesetsthealarmsoundlevelfrom110.(Default=4) PulseVolumesetsthepulsesoundlevelfrom110.(Default=4) ClickTonecontrolsanaudioindicationthatisproducedwhenanactiveareaofthetouch screeniscontacted:

Offdoesnotproduceaclicktone. Onproducesaclicktone.(Default) ClickVolumesetstheclicktonesoundlevelfrom110.(Default=4) ExpressionMR400InstructionsforUseGettingStarted321 Tocontrolthesounds Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 4 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectSoundAdjust. TheSoundAdjustmenuappears.Currentsettingsaredisplayed. Selectthemenuitemforthesoundfunctionthatyouwantto control:

Alarms HRToneSource AlarmVolume PulseVolume ClickTone ClickVolume Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptAlarms andClickTone,whichareselectableontheSoundAdjustmenu.) Thesettingisentered. NOTE When making adjustments to the volume settings, Real Tones Disabled will be displayed and a momentary sound at the setting level will be produced. To your save changes and close the menu select

. 5 Tochangeothersettings,repeatsteps3and4. Set Time & Date Setsthetimeanddate,andthedisplayedtimeanddateformats;seepage214. ToopentheSetTime&Datemenu 322 GettingStartedExpressionMR400InstructionsforUse PresstheSetupkeyandthentheMonitorkey. OntheMonitorSetupmenu,selectSetTime

&Date. 1 2 3 4 5 6 7 8 9 IPx Time Sync Time Format Date Format Second Minute Hour Day Month Year 1 2 3 4 5 6 7 8 9 Thefollowingmenuitemsareavailable:

IPxTimeSyncsynchronizesthetimeanddatesettingsoftheMR400tothatofanIP5(IP5 optionrequired). TimeFormatchangestheformatofthedisplayed(andprinted)hours:minutes:seconds

(hh:mm:ss):

12Hrusesthe12hour(hh)convention(0112)withtheAMorPMdesignation. 24Hrusesthe24hour(hh)convention(0023).(Default) DateFormatchangestheformatofthedisplayed(andprinted)date:

Month/Day/Year:Usesa<mm>/<dd>/<yyyy>format Day/Month/Year:Usesa<dd>/<mm>/<yyyy>format MonthDay,Year:Usesa<mname><dd>,<yyyy>format Secondscrollsthesecondcounter. Minutescrollstheminutecounter. Monthscrollsthemonthcounter. Hourscrollsthehourcounter. Dayscrollsthedaycounter. Yearscrollstheyearcounter. Tosettheformatofthedisplayedtimeordate Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. ExpressionMR400InstructionsforUseGettingStarted323 Step 2 Action OntheMonitorSetupmenu,selectTimeandDate. TheTimeandDatemenuappears.Currentsettingsaredisplayed. Selectthemenuitemforthetimeordatefunctionthatyouwant tochange:

TimeFormat DateFormat Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions. Thesettingisentered. Tochangeothersettings,repeatsteps3and4. 3 4 5 Tosetthetimeordate Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 4 5 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectTimeandDate. TheTimeandDatemenuappears.Currentsettingsaredisplayed. Usethearrowkeysassociatedwitheachtimeordatefunctionthat youwanttochange(leftarrowdecreasesthesetting,rightarrow increasesthesetting):

Second Minute Hour Day Month Year Thesettingischanged. Toadjustothersettings,repeatstep3. Whenfinished,selectthecheckmark

. Thechangesaresavedandthedisplayedtimeisadjusted. 324 GettingStartedExpressionMR400InstructionsforUse Sweep Speed Setsthesweeprateforallwaveforms(displayedandprinted),exceptCO2. ToopentheSweepSpeedmenu PresstheSetupkeyandthentheMonitor key.OntheMonitorSetupmenu,select SweepSpeed. 1 2 50 mm/s 25 mm/s 1 2 Thefollowingspeeds(inmillimetersper second)areavailable:

50mm/s 25mm/s(Default) Toadjustthesweeprateforallwaveforms(exceptCO2) Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectSweepSpeed. TheSweepSpeedmenuappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions:

2 3 50mm/s 25mm/s Thesettingisentered. Resp Speed SetsthesweepratefortheCO2waveform. ToopentheRespSpeedmenu ExpressionMR400InstructionsforUseGettingStarted325 PresstheSetupkeyandthentheMonitor key.OntheMonitorSetupmenu,selectResp Speed. 1 2 3 4 25 mm/s 12.5 mm/s 6.25 mm/s 3.125 mm/s 1 2 3 4 Thefollowingspeeds(inmillimetersper second)areavailable:

25mm/s 12.5mm/s(Default) 6.25mm/s 3.125mm/s ToadjustthesweepratefortheCO2waveform Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectRespSpeed. TheRespSpeedmenuappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions:

2 3 25mm/s 12.5mm/s 6.25mm/s 3.125mm/s Thesettingisentered. Service(Bio-Med) Accessesasubmenuthatcontainssoftwareandfirmwareinformationaboutthesystem,and optionsforNIBPandP1(andP2)pressures,diagnosticsandconfiguration. ToopentheService(BioMed)menu 326 GettingStartedExpressionMR400InstructionsforUse PresstheSetupkeyandthentheMonitor key.OntheMonitorSetupmenu,select Service(BioMed). 1 2 3 4 5 6 7 8 Revision Information Simulation Mode Gas Cal System Config ECG Tests NIBP Tests Backlight Brightness Service Utilities 1 2 3 4 5 6 7 8 NOTE Some menu items require entry of a password for access; see page 2-23. ToaccesstheSERVICE(BIOMED)menuitems Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 4 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)submenuappears. Selectthedesiredmenuitem(somemenusarepassword protected):

RevisionInformation SimulationMode GasCal SystemConfig ECGTests NIBPTests BacklightBrightness ServiceUtilities Theselectionisentered(orenterthecorrectpasswordforaccess). Selectthedesiredmenuoritem,exceptSimulationMode,whichis selectableontheService(BioMed)menu. Thesettingisentered. ExpressionMR400InstructionsforUseGettingStarted327 Step 5 Action Tochangeothersettings,repeatsteps2,3and4. Revision Information Dependingupontheinstalledoptions,displaysrevisioninformationforthesoftwareand firmwareusedintheMR400andwirelessmodules. Toviewtherevisioninformation PresstheSetupkeyandthenthe Monitorkey.OntheMonitorSetup menu,selectService(BioMed).Onthe Service(BioMed)menu,selectRevision Information. 1 2 3 4 5 6 7 8 9 WECG SW:

WECG SW CHKSUM:

WECG FW:

IOP SW:

FPGA FW:

Cart SW:

TEMP FW:

GAS FW:

PICO NIBP SW:

1 2 3 4 5 6 7 8 9 ThedefinitionsfortheitemsdisplayedinRevisionInformationareprovidedbelow. Name WECGSW WECGSWCHKSUM WECGFW IOPSW FPGAFW CartSW TEMPFW GASSW PICONIBPSW Definition SoftwarerevisionofthewECGmodule ChecksumofthesoftwareofthewECGmodule FirmwarerevisionofthewECGmodule Softwarerevisionoftheinput/outputprocessor SoftwarerevisionoftheprocessingelementoftheMR400 SoftwarerevisionoftheMR400cart FirmwarerevisionofTEMPsystem Softwarerevisionofgassystem SoftwarerevisionoftheNIBPsystem 328 GettingStartedExpressionMR400InstructionsforUse Simulation Mode Warning WARNING The MR400 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 MR400 when in simulation mode and never activate simulation mode when a patient is connected. The MR400 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. AllowstheMR400tooperateusinginternally generateddatainsteadofpatientdata. ToopentheSimulationModemenu PresstheSetupkeyandthentheMonitorkey.On theMonitorSetupmenu,selectService(BioMed). OntheService(BioMed)menu,locateSimulation ModeandselectOn.Enterthepassword. Thefollowingcontrolsareavailable:

Offdisplaysnormalmonitoringfunctions.

(Default) Ondisplayssimulationsofmonitoring functions. Toentersimulationmode Step 1 Action EnsurethatnopatientisconnectedtotheMR400. 2 3 4 5 PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)menuappears.Currentsettingsare displayed. LocateSimulationModeandselectOn. WhenEnterPasswordisdisplayed,enterthecorrectsixdigitcode. Simulationwillbedisplayedinthesystemmessageareaofthe simulatedscreen. Toexitsimulationmode,turnoffthepowerswitch. ExpressionMR400InstructionsforUseGettingStarted329 Gas Cal Calibratesthegasfunction(s)whenequippedwiththeCO2ortheAGENToption. NOTE As indicated by displayed message, allow any warm-up to complete before calibrating. ToopentheGasCalmenu PresstheSetupkeyandthenthe Monitorkey.OntheMonitorSetup menu,selectService(BioMed).Onthe Service(BioMed)menu,selectGas Cal. 1 2 3 Zero Cal O2 Cal CO2 Accuracy Check 1 2 3 Thefollowingmenuitemsare available:

ZeroCalInitiatesazero calibration(afunctionthat occursautomaticallyduringnormaluse).ForLoFloCO2optiondetails,seepage72;and fortheAGENToptiondetails,seepage92. O2Calperformsa1minutepressurecalibrationoftheO2sensorfortheAGENToption. Connectionofasamplelineisrequiredforthistest. CO2AccuracyCheckteststheLoFloCO2accuracy(a5%gassourcemustbeconnectedto theMR400).ProvidesaCO2waveformvalue(asapercentage),anatmosphericpressure readingandanumericCO2value(inmmHg). NOTE During the CO2 Accuracy Check, to alert you that the indicated values are not actual patient measurements, the following message will be displayed: CO2 test in progress. Do not use CO2 values for patient monitoring during test. Pressing close will cancel test. System Config ControlstheconfigurationoftheMR400includingoptions,languageandunitofmeasurement forpressures. 330 GettingStartedExpressionMR400InstructionsforUse ToopentheSystemConfigmenu PresstheSetupkeyandthenthe Monitorkey.OntheMonitorSetup menu,selectService(BioMed).Onthe Service(BioMed)menu,selectSystem Config. P1 P2 SPO2 ECG 1 1 ECG 2 2 3 NIBP 4 5 6 7 Gas Bench 8 9 10 11 12 13 Gas Units RESP TEMP Language ECG Notch Filter Pressure Units Thefollowingmenuitemsareavailable:

1 2 3 4 5 6 7 8 9 10 11 12 13 ECG1configurestheMR400forECG1 ECG2configurestheMR400forECG2 NIBPconfigurestheMR400forNIBP P1configurestheMR400forP1 P2configurestheMR400forP2 SPO2configurestheMR400forSPO2 GasBenchconfigurestheMR400forthegasbenchoption,whereCO2onlyselectsthe CO2Loflooption,AgentsselectstheAGENToption RESPsetstheconfigurationoftheunitforbellowsderivedRESP TEMPconfigurestheMR400forTEMP Languagesetsthelanguageforthedisplayedinformation:

English(Default) Deutsch Espanol Francais ExpressionMR400InstructionsforUseGettingStarted331 Portuguese Italiano Dansk Svenska Norsk NLD ECGNotchFilterappliesanotchfiltertotheECGsignal:

Off 50Hz 60Hz(Default) PressureUnitssetstheunitofmeasureforP1,P2,andNIBPpressurereadings:

mmHg(Default) kPa GasUnitssetstheunitofmeasureforCO2pressurereadings:

mmHg(Default) kPa ECG Tests AccessestestingfunctionsforECG. ToopentheECGTestsmenu PresstheSetupkeyandthenthe Monitorkey.OntheMonitorSetup menu,selectService(BioMed).Onthe Service(BioMed)menu,selectECG Tests. 1 ECG Signal Test 1 Thefollowingmenuitemsare available:

ECGTestSignalcontrolsawECG modulegenerated1mVpeak topeaksquarewave,where60 BPMwillbedisplayedintheECG VSboxandECGTestSignalwillbedisplayedinthealarmflagarea(andprintedwhen outputtotheprinter,ifequipped):

Offdoesnottransmitthetestsignal.(Default) Ontransmitsthetestsignal. 332 GettingStartedExpressionMR400InstructionsforUse NOTE ECG Test Signal is unavailable when Filter Mode > Advanced 2 is selected; see 5-31. TocontroltheECGTestSignal Step 1 Action EnsurethatthewECGmoduleiscommunicatingwiththeMR400. 2 3 4 PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)menuappears.Currentsettingsare displayed. LocateECGTestSignalandselectthedesiredsetting:

Off On Thesettingisentered. NIBP Tests AccessescalibrationandtestingfunctionsforNIBP. NOTE If Module Not Calibrated is displayed, then all options in the NIBP Tests menu will be locked until NIBP is successfully calibrated. ToopentheNIBPTestsmenu ExpressionMR400InstructionsforUseGettingStarted333 PresstheSetupkeyandthenthe Monitorkey.OntheMonitorSetup menu,selectService(BioMed).Onthe Service(BioMed)menu,selectNIBP Tests. 1 2 3 4 5 Calibrate Static Test Leak Test Stress Test High Range Check Thefollowingmenuitemsare available:

1 2 3 4 5 CalibrateperformscalibrationoftheNIBPsystem.(Passwordrequired) StaticTestperformsastaticpressuretestoftheNIBPsystem.(Passwordrequired) LeakTestperformsapressureleaktestoftheNIBPsystem(seenotebelow). StressTestperformsapressurestresstestoftheNIBPsystem.(Passwordrequired) HighRangeCheckperformsahighpressuretestoftheNIBPsystem.(Passwordrequired) NOTE If an error is reported while the Leak Test is in progress, the test will be canceled and user will be prompted with the message: NIBP Bench Error. Press Start to try again. Toperformthesetests Seereferencetheservicemanualfordetails. Backlight Brightness Adjuststhebrightnessofthetouchscreen. ToopentheBacklightBrightnessmenu 334 GettingStartedExpressionMR400InstructionsforUse PresstheSetupkeyandthentheMonitor key.OntheMonitorSetupmenu,select Service(BioMed).OntheService(BioMed) menu,selectBacklightBrightness. Thefollowingbrightnesslevelsareavailable:

1(Minimum) 2 3 4 5 6(Default) 7 8(Maximum) Tocontrolthebrightnessofthedisplaybacklight Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)menuappears.Currentsettingsare displayed. SelectBacklightBrightnessandthenenterthedesiredbrightness level:

18 Thesettingisentered. Service Utilities Accessesservicerelatedfunctions(apasswordisrequiredforaccess). ToopentheServiceUtilitiesoption ExpressionMR400InstructionsforUseGettingStarted335 PresstheSetupkeyandthenthe Monitorkey.OntheMonitorSetup menu,selectService(BioMed).Onthe Service(BioMed)menu,selectService Utilities.Enterthepassword. 1 2 3 NIBP Diagnostics CO2 Diagnostics Radio Diagnostics 1 2 3 Thefollowingmenuitemsareavailable:

NIBPDiagnosticsopensawindowthatdisplaysNIBPdiagnosticdata. CO2DiagnosticsopensawindowthatdisplaysCO2diagnosticdata. 336 GettingStartedExpressionMR400InstructionsforUse RadioDiagnosticsopensawindowthatdisplaysradiodiagnosticdata. ExpressionMR400InstructionsforUseGettingStarted337 338 GettingStartedExpressionMR400InstructionsforUse CHAPTER 4 Alarms Thealarminformationhereappliestoallmeasurements.Measurementspecificalarm informationisdiscussedinthesectionsonindividualmeasurements.Themonitorprovides patientalarmsandINOPalarms. PatientAlarms Patientalarmswillilluminatearedoryellowalarmlight,wherearedalarmlightindicatesahigh priorityalarmtoalertyoutopotentiallylifethreateningsituationsforyourpatient(forexample, adisconnectedcatheter).Ayellowalarmlightindicatesalowerprioritypatientalarm(for example,arespirationalarmlimitviolation). Patientalarmsmayalsogenerateflashingnumericvaluesorotherindications,alarmflagsand soundanaudiblealarm(providedthatahigherpriorityalarmsounddoesnotoverrideit). Forexample,ifapatientsheartrateclimbsto71BPM(whichisabovethesettingoftheupper alarmlimit)aphysiologicalalarmconditionisdeclared. 1 2 1 2 Medium priority alarm example (ECG heart rate value) Violated (high) alarm limit setting INOPs INOPsarestatusandtechnicalalarmstheyindicatethatthemonitorcannotmeasureordetect alarmconditionsreliably;seepage431foralisting.Dependinguponthenatureofthecondition detected,INOPswillilluminatethealarmlight,generateanalarmflag,andsoundanaudible indicatortone(providedthatahigherpriorityalarmsounddoesnotoverrideit).Otherstatus andtechnicalalarmshaveamediumorhighprioritydependinguponthenatureofthecondition detected. MultipleAlarms Patientalarmsaremutuallyexclusiveandthehighestpriorityalarmwillbeindicatedbythealarm light;ifahighpriorityalarmandamediumpriorityalarmarepresentsimultaneously.thered alarmlightwillbeon,buttheyellowalarmlightwillnotbe. ExpressionMR400InstructionsforUseAlarms41 Thebluealarmlightcanbeonatthesametimeastheredoryellowalarmlight.Whenanumeric valuebecomesmissingduetoanINOP,theINOPalarmwillbepresentaswellasthepatient alarm(duetothemissingvalue),withbothoriginatingfromthesamecause. AlarmDelays Thereisanalarmsoundandanalarmlightilluminationdelayofnomorethan4secondsfollowing thedisplayedalarmflag,providedthatthealarmconditionstillexistsafterthisdelay. 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 MR400. 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 MR400 so that you maintain a clear view of the display. Visual Alarm Indications Dependinguponthealarmcondition,visualalarmindicationscanincludeanalarmflag,a flashingnumeric,andanilluminatedalarmlight;whenmultiplealarmsaredetected,multiple visualindicationsmaybepresented. Alarm Flags Alarmflagsarevisualindicatorsthatcontainanalarmmessagedisplayedonabackgroundcolor thatidentifiesthepriorityofthealarm(seetablebelow).Analarmflagisdisplayedforthe durationofanalarmcondition.Multiplealarmflagsaredisplayedwhenmultiplealarm conditionsexist. AlarmPriority DisplayedBackgroundColor High(patientalarm) Medium(patientalarm) INOP(statusortechnicalalarm) Red Yellow Blue 42AlarmsExpressionMR400InstructionsforUse AlarmflagsassociatedwithavitalsignaredisplayedalongsidetheVSboxofthatparameter(see illustrationbelow),whilealarmflagsassociatedwiththesystemaredisplayedinthesystem messagearea(middleandtopcenterofthetouchscreen,seepage221).Whenmultiplealarm flagsarepresent,theywillbestackedinacolumn. 1 1 Alarm flag (an INOP in this example) Flashing Numeric Duringanpatientalarmcondition,thevitalsignnumericwillchangecolorandflashtoindicate thesource,typeandpriorityofthealarm:

Highprioritypatientalarmrednumeric,flashingat1.5Hzwitha50%dutycycle. Mediumprioritypatientalarmyellownumeric,flashingat0.75Hzwitha50%dutycycle. Whiletheviolationcontinues,thenumericoftheviolatedparameterwillflashinprioritycolorof thedetectedalarm. Alarm Light Duringanalarmcondition,thealarmlight(see inset)canilluminatetoprovidea360degree, visualindicationofthealarmpriority,asdetailed inthetablebelow. Multiplecolorscanbeilluminatedwhen multiplealarmconditionsexist.Thealarmlight isamenucontrolledfeature;seepage420for settingdetails. Alarm light, red or yellow Alarm light, blue Speaker Display panel AlarmPriority LightColor Indication High(patientalarm) Medium(patientalarm) INOP(statusortechnicalalarm) Red Yellow Blue Flashing,1.5Hzwitha50%dutycycle Flashing,0.75Hzwitha50%dutycycle Steady ExpressionMR400InstructionsforUseAlarms43 Audible Alarm Indications WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Dependingupontheseverityandtypeofthealarmcondition,alarmprioritytoneswithdistinct pitchesaresoundedbythespeaker(seeillustrationonpage43).Whenmultiplealarmsare detected,thehighestpriorityalarmisannounced. Alarm priority Fixed Pitch Mnemonic Notes High Medium INOP c c c c c c c c e c Onceactivated,anaudiblealarmindicationcontinuesaslongasthealarmconditionispresentor untilyouacknowledgethealarmbypressingtheAudioPausekeyortheAlarmkey(orbyplacing theMR400insuspendmode). Alarm Sound State Indication Dependinguponthecurrentsetting,oneofthreepossiblesymbolsareprovidedtoindicatethe alarmsoundstate,whichisdisplayedatalltimesintheinformationbar(seepage214).Symbol definitionsforthealarmsoundstateareprovidedinthetablebelow. Displayed Symbol Alarm Sound State Alarm audio armed Alarm audio paused Alarm audio off 44AlarmsExpressionMR400InstructionsforUse Initial Audible Alarm Setting Indications Afterpowerupandimmediatelyfollowingtherecallofastoredsetup,theMR400providesan indicationofthealarmvolumebysoundingthealarmtoneatitscurrentlyadjustedsettingfor5 secondsandbydisplayingCheckAlarmVolume. Audiopausedistheinitialalarmstateandthen,followingawaitperiodof120seconds,armed becomesthenormalalarmstate,where:

Analarmwillsoundwhileanalarmconditionexists,providedthatanyprealarmsound delayhasexpiredandthatthealarmaudioarmedsymbolisdisplayed. Alarmflagsrelatedtootheralarmsoundstateswillberemovedfromthedisplay. Analarmconditionnotpreviouslyplacedinanalarmaudiooffstatewillcausethealarmto sound. Controlling the Alarm Audio and Light Indications Alarmaudioindicationsandthealarmlightcanbecontrolledtomeetthedesiredlevelof responseusingtheAudioPausekeyortheAlarmkey. Note When an alarm is indicated, always confirm the alarm conditions with clinical observations of the patient before administering interventions. Failure to do so may result in inappropriate intervention. 1 2 1 2 Audio Pause key Alarm key ExpressionMR400InstructionsforUseAlarms45 Audio Pause Mode Audiopausemodecanisusefultotemporarilysilencealarmsandtotemporarilyextinguishthe alarmlight(forexample,whenchangingECGleadsorduringotheruseractivitiesthatmightcause afalsealarm). AudiopausemodeisindicatedwhentheAudioPausedalarmflag,theaudiopausedsymbol(see page44)andacountdowntimeraredisplayed.(The120secondcountdowntimerperiodisnot useradjustable.)Duringthisperiod,theaudiblealarmwillbesuspendedforanynewalarm conditionsthatoccur.Anymessagesrelatedtootheralarmsoundstateswillberemoved. ToactivateAudioPause PresstheAudioPausekey:

Ifthealarmisnotsounding,pressthekeyonce. Ifthealarmissounding,pressthekeytwice. TodeactivateAudioPause Waituntilthe120secondcountdownreacheszero(0),or PresstheAudioPausekey. Audio Off Mode Inaudiooffmode,thealarmtonewillcease,thealarmlightwillbeextinguished,andtheAudio Offmessageandtheaudiooffsymbol(seepage44)willbedisplayed.Anynewalarmcondition willcauseaudiooffmodetobeexitedandthealarmtonetobesounded.However,acurrent alarmconditionpreviouslysilencedwillnotsoundagainunlesstheconditionreturnswithinlimits andthenviolatesalimitagain. Audiooffmodeallowsyoutodisablethealarmtoneandalarmlightduringanalarmcondition, whileallowingnewalarmconditionstoreactivateallalarmfunctions.Whiletheviolation continues,thenumericoftheviolatedparameterwillflashinprioritycolorofthedetected alarm. WARNING An active silenced alarm may not be accompanied by the Audio Off message and symbol

, if Audio Paused has been activated, or if a subsequent additional alarm has occurred and was self-corrected. ToactivateAudioOff PresstheAlarmkey. TodeactivateAudioOff PresstheAlarmkeyagain. 46AlarmsExpressionMR400InstructionsforUse Alarm Volume Alarm Reset Theloudnessofthealarmsoundscanbeadjusted(4586dB,typical). WARNING 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 MR400, 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. Tocontrolthealarmvolume Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 4 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectSoundAdjust. TheSoundAdjustmenuappears.Currentsettingsaredisplayed. SelectAlarmVolume. 110 Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions. Thesettingisenteredandamomentarysoundatthe correspondinglevelisproduced Resettingthealarmresultsinthefollowingalarmsystembehaviors:

Theauditoryalarmsignalsofphysiologicalalarmconditionscease,enablingthealarm systemtorespondtoasubsequentalarmcondition. Alarmlightindicationscease. Alarmflagsforanyexistingalarmscontinueaslongasthosealarmconditionsexist. Thealarmsystemisenabledimmediatelysothatitcanrespondtoasubsequentalarm condition. ThevisualalarmsignalsofINOPconditionsdonotceaseaslongastheINOPalarm conditionexists. ThealarmcanberesetbypressingtheAudioPausekeyonetime. ExpressionMR400InstructionsforUseAlarms47 Managing Alarm Functions 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. TheMR400canbesettoprovidevisualalarmsignalsonly,orbothvisualandaudiblealarm signals.Theaudiblealarmstateswillhavenoeffectonanyofthevisualalarmsdisplayedbythe MR400(orIP5,ifequipped). AllsettingsintheAlarmsmenu(exceptAlarmSound)canbestoredandrecalled. Restrictionstoalarmpresetsarenotprovidedduetothefastpacedworkflow,shortaverage durationtimeofMRIscans,differentpatienttypesscheduledforMRIprocedures,anddirect patientsupervisionprovidedduringMRIprocedures. Note If the MR400 is networked to an IP5, alarm indications occur at both the MR400 and the IP5; and control of alarms, including sound level, is localized to the device (MR400 or IP5) indicating the alarm condition. Showing or Hiding Current Alarm Limits CurrenthighandlowalarmlimitsettingsaredisplayedintheVSboxofeachmonitored parameterbydefault(exceptbellowsderivedrespiration). Tocontrolthedisplayfunctionforthealarmlimitsettings Step 1 Action PresstheSetupkeyandthentheAlarmskey. TheAlarmsmenuappears.Currentsettingsaredisplayed. 48AlarmsExpressionMR400InstructionsforUse Step 2 Action SelectLimitsDisplay. TheLimitsDisplaymenuappears.Thecurrentsettingis highlighted. Selectthedesiredoptionfordisplayofthealarmlimitsettings:

3 Off On Thesettingisselected. Adjusting the Alarm Limits WARNING Alarm limits can be set to a wide range of values, including off (with the exception of O2, N2O and FiCO2). It is the responsibility of the operator of the MR400 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. TheMR400providesversatilemethodstocontrolthesettingsforthepatientparameteralarms. Eachpatientparameter(withtheexceptionofbellowsrespiration)hasalowandhighalarmlimit setting(seethetableonpage422),whichcanbechangedmanuallyorautomatically,unlessthe parameterisoff. Alarm Limit Controls Individualalarmlimitsettingscanbeadjustedbytouchingtherespectiveparameterlabelinthe AlarmsortheGasAlarmsmenu. ExpressionMR400InstructionsforUseAlarms49 1 32 4 5 16 15 14 13 12 11 10 9 8 7 6 Parameter label for alarm limit settings (active adjustment shown) Low button Lower alarm limit setting Upper alarm limit setting Enter button 1 2 3 4 5 High button 6 Off button 7 Clear entry button 8 9 Decimal point button 10 Gas Alarms button 11 Alarms button 12 13 14 Decrement button Current adjustment 15 Increment button 16 Plus / minus button Keypad 410AlarmsExpressionMR400InstructionsforUse The Alarm Window Alarmlimitshaveminimumandmaximumvaluesthatarenotadjustable(seepage422).Within theminimumandmaximumalarmlimits,adjustablelowerandupperlimitsettingsestablishan alarmwindow.Vitalsignmeasurementsthatfallwithinthealarmwindowwillnotresultinan physiologicalalarm.Itisonlywhenavitalsignmeasurementexceedsthealarmwindowfora monitoredparameterthataphysiologicalalarmwillbedeclared.(Anillustrationisshownbelow.) 1 2 3 4 5 6 1 2 3 4 5 6 Parameter name (TEMP in this example) Alarm limit, minimum Lower alarm limit setting Alarm window Alarm limit, maximum Upper alarm limit setting Advanced Alarm Functions TheMR400featuresadvancedalarmfunctionsthatcanalertyoutospecificormoreextreme physiologicalconditions.Whenadjustingtheseadvancedfunctionalarms,thefollowingrules governthealarmsettings:

ExtremeBradycardiaAlarmSetting TheExtremeBradycardiaalarmsettingisestablishedbythesettingoftheExtremeBradycardia deltavalue.TheExtremeBradycardiadeltavaluecannotbegreaterthanthedifferencebetween theHRlowalarmlimitsettingandthealarmlimitminimum.Themaximumallowabledeltavalue is50.Seepage524forsettingdetails. TheExtremeBradycardiadeltavaluewillretainitsadjustedvalueastheHRlowalarmlimit settingisadjustedupward,butwillbegintoshrinkinvalueasthelowalarmlimitsettingis adjustedclosertothealarmlimitminimum. ExtremeTachycardiaAlarmSetting TheExtremeTachycardiaalarmsettingisestablishedthesettingoftheExtremeTachycardia deltavalue.TheExtremeTachycardiadeltavaluecannotbegreaterthanthedifferencebetween theHRalarmlimitmaximumandthehighalarmlimitsetting.Themaximumallowabledelta valueis50.Seepage524forsettingdetails. ExpressionMR400InstructionsforUseAlarms411 TheExtremeTachycardiadeltavaluewillretainitsadjustedvalueastheHRhighalarmlimit settingisadjusteddownward,butwillbegintoshrinkinvalueasthehighalarmlimitsettingis adjustedclosertothealarmlimitmaximum. DesatAlarmSetting TheDesatalarmsettingisrestrictedtoamaximumvaluethatis2lesstheSPO2lowalarmlimit setting,whiletheminimumsettingcanbeaslowasthealarmminimum.Seepage611forsetting details. AslongastheSPO2parameterison,theDesatalarmvaluewillretainthissettingevenifthefunc tionisturnedoffandon. TheSPO2alarmadjustmentsaredesignedtogiveprioritytotheDesatalarmsetting.Therefore, theSPO2lowandhighalarmlimitsmayalsobeadjustedbasedonachangemadetotheDesat alarmsetting.WhenevertheDesatalarmsettingischanged,thefollowingrulesdeterminethe lowerandupperSPO2alarmlimits:

IftheDesatalarmwasturnedonafterbeingsetandturnedoff,thenifthelastsetvalueof theSPO2lowalarmlimitislessthantheDesatalarmsettingplus2,theSPO2lowalarm limitwillbesettotheDesatalarmsettingplus2. IftheDesatalarmisadjustedupwardsothatthesettingisgreaterthanorequaltothe SPO2lowalarmlimitminus2,thentheSPO2lowalarmlimitwillbeincreasedbythe systemsuchthattheDesatalarmsettingplus2isalwaysmaintained(i.e.,thelowalarm limitwillalwaysmovetostaytwogreaterthanDesatalarmsetting).Iflowalarmlimitis alteredduetothisscenario,lowalarmlimitwillretainthisalteredvalueeveniftheDesat alarmsettingisadjusteddownward. TheSPO2highalarmlimitwillbeadjustedasnecessaryinrelationtothelowalarmlimitas perthenormalbehavioroflowandhighalarmlimits. TheSPO2lowalarmlimitwillbeallowedtobeadjusteddownwardonlyuntilitisequalto theDesatalarmsettingplus2.Nofurtherdownwardadjustmentoflowalarmlimitwillbe alloweduntiltheDesatalarmsettingisadjusteddownward. Setting Alarm Limits Globally Globalchangestoallofthelowerandupperalarmlimitsettingscanbemadeautomaticallyby pressingtheusingthe1TouchAlarmskey.Theseglobalchangesarecalculatedusing percentagesselectedinthe1TouchHigh%andthe1TouchLow%options;seepage417. Duringcalculationsifapatientsmonitoredvalueissohighorlowthatitwouldexceedthealarm limitrangefortheparameter,thenthealarmlimitwillbesettothehighestorlowestpossible valuebutnotoff,asindicatedinthetableonpage422.Forexample,ifafterpressingthe1 TouchAlarmskey,apatientsSPO2upperalarmlimitsettingwas99(thehighestallowable value),thenanalarmwillbegeneratedifthepatientsreadingreaches100.(Toturnoffanalarm limit,seeSettingAlarmLimitsIndividuallyonpage413.) AlsonotethatsettingalarmlimitsgloballymayresultinalowerSPO2alarmlimitthanthe defaultsetting.ForapatientthathasanSpO2readingof99%,thenewupperlimitwillbe99but thenewlowerlimitwillbe79(insteadof85)ata1TouchHigh%of20(factorydefault). 412AlarmsExpressionMR400InstructionsforUse Toadjusttheupperandloweralarmlimitsettingsforallmonitoredparameters Step 1 Action PresstheSetupkeyandthentheAlarmskey. 2 3 4 5 6 TheAlarmsmenuappears.Currentsettingsaredisplayed. Select1TouchHigh%. The1TouchHigh%menuappears.Thecurrentsettingis highlighted. Selectthedesiredpercentage:

5%

10%

15%

20%

30%

Thesettingisselected. SelectLowerWindow. TheLowerWindowmenuappears.Thecurrentsettingis highlighted. Selectthedesiredpercentage:

5%

10%

15%

20%

30%

Thesettingisselected. Pressthe1TouchAlarmskey. Allactivealarmlimitsettingsarechanged. Setting Alarm Limits Individually Lowerandupperalarmlimitsettingsforeachparametercanbeindividuallyadjustedinthe Alarmsmenu(orinthemenuoftheparameterthatyouwanttochange,bytouchingthealarm limitsettingsinparametersVSbox). IntheAlarmsmenu,lowerandupperalarmlimitsettingsforparametersareprovided,asshown below.(Forinformationaboutgasalarms,seechapter9.)Anindividualalarmlimitsettingcanbe adjustedbytouchingthelowerorupperalarmlimitoftherespectiveparameterintheAlarms menu. ExpressionMR400InstructionsforUseAlarms413 15 14 13 12 11 10 9 8 1 2 3 4 5 6 7 TEMP (Temperature) P1 (Sys) (P1 [Systolic]) P1 (Dia) (P1 [Diastolic]) P1 (Mean) P2 (Sys) (P2 [Systolic]) P2 (Dia) (P2 [Diastolic]) P2 (Mean) CO2 (RESP) (CO2 [Respiration]) CO2 (Fi) (CO2 [Fractional inspired]) CO2 (Et) (CO2 [End-tidal]) 1 2 3 4 5 6 7 8 9 10 11 NIBP (Mean) 12 NIBP (Dia) (NIBP [Diastolic]) 13 NIBP (Sys) (NIBP [Systolic]) 14 15 SPO2 HR (Heart rate) ToadjustthealarmlimitsettingsforasingleparameterintheAlarmsmenu Step 1 Action PresstheSetupkeyandthentheAlarmskey. TheAlarmsmenuappears.Currentsettingsaredisplayed. 414AlarmsExpressionMR400InstructionsforUse Step 2 Action PressthedesiredparameterlabelontheAlarmsmenu:

HR SPO2 NIBP(Sys) NIBP(Dia) NIBP(Mean) CO2(Et) CO2(Fi) CO2(RESP) TEMP P1(Sys) P1(Dia) P1(Mean) P2(Sys) P2(Dia) P2(Mean) Thebackgroundoftheselectedparameterbecomeshighlighted

(TEMPinthisexample). Dependinguponthealarmlimittobemodified,presstheLow buttonortheHighbutton. 3 Parameter label Low button High button Inthisexample,theLowbuttonwasselectedtoadjustthelower alarmlimitsetting. ExpressionMR400InstructionsforUseAlarms415 Step 4 Action Usetheincrementorthedecrementbuttontoadjustthesetting. Or,directlyinputthevalueusingthekeypad,theplus/minus buttonand/orthedecimalpointbuttonthenpresstheEnter button.(Foritemlocations,seeAlarmLimitControlsonpage49.) Adjusted lower limit Thecurrentadjustmentwillreflectthesetting.(Inthisexample,the lowerlimitsettingwasadjustedfrom36to33.) Lower alarm limit setting 5 6 7 Tochangetheremainingsetting,repeatsteps3and4. Tochangeanyremainingparameters,repeatsteps2,3,and4. PresstheMainScreenkeytoclosethemenu. NewlimitsettingswillbeindicatedintheparametersVSbox. Restoring Alarm Limit Defaults WheneverthePatientTypesettingischanged(seepage311),theMR400automaticallyrestores thedefaultvaluestoallthealarmlimitsettings;seepage424foralistingofthedefaultvalues. Toimmediatelyrestorethealarmlimitstothedefaultsettings Step 1 Action PresstheSetupkeyandthentheAlarmskey. TheAlarmsmenuappears.Currentsettingsaredisplayed. SelectDefaultLimits. 2 Thealarmlimitsettingsarereturnedtothedefaultvalues. 416AlarmsExpressionMR400InstructionsforUse Enabling Print on Alarm IftheMR400isconnectedtoanIP5thatisequippedwithaprinter,aprintoutcanbe automaticallygeneratedwhenaphysiologicalalarmoccurs.SeetheIP5IFUfordetails. Alarms Menu TheAlarmsmenuallowsyoutoconfiguretheMR400forsetupandcontrolofthevitalsign alarms. ToopentheAlarmsmenu PresstheSetupkeyandthentheAlarmskey. Alarms menu Setup key Alarms key Gas Alarms button Alarms button Notes Select the Alarms button to access the alarm limits settings for parameters. Select the Gas Alarms button to access the alarm limits settings for AGENT and GAS. ExpressionMR400InstructionsforUseAlarms417 ThefollowingAlarmsmenuitemsareavailable:

1-Touch High %

1-Touch Low %

Alarm Sound Alarm Light Default Limits Limits Display TochangesettingsintheAlarmsmenu Step 1 Action PresstheSetupkeyandthentheAlarmskey. TheAlarmsmenuappears.Currentsettingsaredisplayed. Selectanyofthefollowingmenuitems:

1TouchHigh%

1TouchLow%

AlarmSound AlarmLight DefaultLimits LimitsDisplay Forinformationabouttheseoptions,seetheappropriatesections below. Selectthedesiredmenuitem. Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions. Thesettingisentered. Tochangeothersettings,repeatsteps2,3and4. 2 3 4 5 1-Touch High %

Setsapercentvalueusedtocalculatethehighalarmlimitswhenthe1TouchAlarmskeyis pressed.Thecurrentparametervalueisbracketedwiththepercentagessetinthismenuandin the1TouchLow%menu. Thefollowingoptionsareavailable:

5%

418AlarmsExpressionMR400InstructionsforUse 10%

15%

20%(Default) 30%

Tosettheupperwindow SeeSettingAlarmLimitsGloballyonpage412. Note If, during calculation, a patients monitored value is so high that it exceeds the alarm limit range for the parameter, then the respective alarm limit will be set to the highest value but not off, as indicated in the table on page 4-22. 1-Touch Low %

Setsapercentvalueusedtocalculatethelowalarmlimitswhenthe1TouchAlarmskeyis pressed.Thecurrentparametervalueisbracketedwiththepercentagessetinthismenuandin the1TouchHigh%menu. Thefollowingoptionsareavailable:

5%

10%

15%

20%(Default) 30%

Tosetthelowercalculationvalue SeeSettingAlarmLimitsGloballyonpage412. Note If, during calculation, a patients monitored value is so low that it exceeds the alarm limit range for the parameter, then the respective alarm limit will be set to lowest possible value but not off, as indicated in the table on page 4-22. ExpressionMR400InstructionsforUseAlarms419 Alarm Sound 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 MR400, always ensure that the alarm sound can be heard above the ambient noise level; otherwise, treatment of the patient could be delayed. Controlsthealarmsound(identicaltoandinteractivewithAlarmsintheMonitorSetup>Sound Adjustmenu). Thefollowingoptionsareavailable:

Offturnsoffthealarmsound,asindicatedbythealarmaudiooffsymbol(seepage44).

(Onlythealarmsoundwillbedisabled;visualalarmindicationswillcontinue.) Onturnsonthealarmsound,asindicatedbythealarmaudioarmedsymbol(seepage4 4).(Default) Tocontrolthealarmsound Step 1 Action PresstheSetupkeyandthentheAlarmskey. TheAlarmsmenuappears.Currentsettingsaredisplayed. LocateAlarmSoundandselectthedesiredsetting:

2 Off On Thesettingisentered. Alarm Light Setsthebehaviorofthealarmlightfollowingthedetectionofanalarm. Thefollowingoptionsareavailable:

Continuousilluminatesthealarmlightforthedurationofanalarmcondition.(Default) Temporaryilluminatesthealarmlightfor25secondsduringanalarmcondition.(Ifthe MR400isplacedinsuspendmodeorifthealarmissilencedorpausedduringthisperiod, thenuponexitingthealarmlightwillrestartfor25seconds.) Offdoesnotilluminatethealarmlightduringanalarmcondition. 420AlarmsExpressionMR400InstructionsforUse Note As defined in the table below, the current Alarm Light setting is indicated by the displayed symbol on the information bar (see page 2-14). Alarm Light Setting Displayed Symbol Continuous Temporary Off Toadjustthealarmlightsetting Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectAlarmLight. TheAlarmLightmenuappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions:

2 3 Continuous Temporary Off Thesettingisentered. Default Limits Automaticallysetsthelowalarmlimitsandhighalarmlimitsforallparameterstothedefault values(seethetableonpage424). Tosetthealarmlimitsettingstothedefaultlimits SeeRestoringAlarmLimitDefaultsonpage416. Limits Display ControlsthevisibilityofthealarmlimitsettingsintheVSboxes. Thefollowingoptionsareavailable:

ExpressionMR400InstructionsforUseAlarms421 Offdoesnotdisplaythealarmlimitsettings. Ondisplaysthealarmlimitsettings.(Default) Tocontrolthedisplayfunctionforthealarmlimitsettings Step 1 Action PresstheSetupkeyandthentheAlarmskey. TheAlarmsmenuappears.Currentsettingsaredisplayed. SelectLimitsDisplay. TheLimitsDisplaymenuappears.Thecurrentsettingis highlighted. Selectthedesiredoptionfordisplayofthealarmlimitsettings:

2 3 Off On Thesettingisselected. Adjustable Alarm Limit Ranges Withtheexceptionofbellowsrespiration,eachparameteralarmhasadjustablelimitsasindicatedin thetablesbelow.Notethatthealarmlimitnumericvaluescanbesettooff,withtheexceptionof O2,N2O,FiCO2.TheMR400alsopreventscrossoveroflowandhighalarmlimitsettings,anda minimumnumberofunitsseparatestheselowandhighsettings.Whenaparameterhasbeen turnedoff,itsalarmlimitswillbeoff.Alarmlimitsareadjustablebythesameresolutionspecifiedin eachparameter'smeasurementresolutionsetforthinAppendixA. Note The minimum and maximum values for the low and high limits represent the most extreme settings possible. For some vital signs, these values can be obtained for a low or high alarm limit only if the other limit is off. ThetablebelowprovidesthealarmlimitrangesfortheMR400. Vital Sign or Parameter HR SPO2 CO2 (Et) Unit Patient Type BPM Percent mmHg kPa All All All Low Alarm Limit*

High Alarm Limit*

Minimum Maximum Minimum Maximum Low and High Limit Separation Off, 30 Off, 50 Off, 5 Off, 0.7 250 100 60 8.0 60 70 5 0.7 250, Off 100, Off 90, Off 12.0, Off 2 2 2 422AlarmsExpressionMR400InstructionsforUse Vital Sign or Parameter CO2 (Fi) CO2 (Resp) P1 and P2 Temperature NIBP Systolic Mean Diastolic NIBP Systolic Mean Diastolic NIBP Systolic Mean Diastolic Unit Patient Type Low Alarm Limit*

High Alarm Limit*

Minimum Maximum Minimum Maximum Low and High Limit Separation mmHg kPa RPM mmHg kPa C F mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa All All All All Adult Adult Adult Pediatric Pediatric Pediatric Neo Neo Neo No low alarm Off, 4 Off, -30 Off, -4.0 Off, 20.0 Off, 68.0 Off, 30 Off, 4.0 Off, 20 Off, 2.7 Off, 10 Off, 1.3 Off, 30 Off, 4.0 Off, 20 Off, 2.7 Off, 10 Off, 1.3 Off, 30 Off, 4.0 Off, 20 Off, 2.7 Off, 10 Off, 1.3 40 250 33.3 44.0 111.2 270 36.0 255 34.0 245 32.7 180 24.0 160 21.3 150 20.0 130 17.3 120 16.0 100 13.3 0 20

-30

-4.0 20.0 68.0 30 4.0 20 2.7 10 1.3 30 4.0 20 2.7 10 1.3 30 4.0 20 2.7 10 1.3 20, Off 2.7, Off 100, Off 250, Off 33.3, Off 44.0, Off 111.2, Off 270, Off 36.0, Off 255, Off 34.0, Off 245, Off 32.7, Off 180, Off 24.0, Off 160, Off 21.3, Off 150, Off 20.0, Off 130, Off 17.3, Off 120, Off 16.0, Off 100, Off 13.3, Off 2 2 2 1 2 2 2 2 2 2 2 2 2

*ForallalarmlimitvaluesthatmaybedisplayedinunitsofkPa,allow+/0.1kPaofvariancetoaccountforroundingerrorthatmay occurwhenconvertingfrommmHgtokPa. Thefollowingtableprovidesthealarmlimitrangesfortheanestheticagentgasesandoxygenfor allpatienttypes. Breath Phase and Gas Unit DES (Et), Expired Desflurane DES (Fi), Inspired Desflurane ENF (Et) Expired Enflurane ENF (Fi) Inspired Enflurane HAL (Et) Expired Halothane HAL (Fi) Inspired Halothane ISO (Et) Expired Isoflurane ISO (Fi) Inspired Isoflurane Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Low Alarm Limit High Alarm Limit Minimum Maximum Minimum Maximum Low and High Limit Separation Off, 0.1 Off, 0.1 Off, 0.1 Off, 0.1 Off, 0.1 Off, 0.1 Off, 0.1 Off, 0.1 18.0 18.0 5.0 5.0 5.0 5.0 5.0 5.0 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 18.0, Off 18.0, Off 5.0, Off 5.0, Off 5.0, Off 5.0, Off 5.0, Off 5.0, Off 1 1 1 1 1 1 1 1 ExpressionMR400InstructionsforUseAlarms423 Breath Phase and Gas Unit Low Alarm Limit High Alarm Limit Minimum Maximum Minimum Maximum Low and High Limit Separation SEV (Et) Expired Sevoflurane SEV (Fi) Inspired Sevoflurane N2O (Fi) Inspired Nitrous Oxide O2 (Fi) Inspired Oxygen Vol. %

Vol. %

Percent Percent Off, 0.1 Off, 0.1 No low alarm 18 8.0 8.0 100 0.1 0.1 0 18 8.0, Off 8.0, Off 80 100 1 1 1 1 Alarm Limit Factory Defaults Intheeventofpowerloss,anyalarmlimitsettingsthatwerechangedwillbelost.Allsettingsthat mayhavebeenmodifiedtosuitaparticularpatientshouldbeconfirmedbeforemonitoring. Atpowerup,theMR400willautomaticallysetallalarmlimitsasdeterminedbythedefault selectedintheEditUserSettingsmenu;seepage315.Thefactorydefaultalarmlimitsarelisted inthetablebelow. Note You are restricted from making changes to the factory default settings. Vital Sign or Parameter Unit Heart Rate Heart Rate - Extreme Bradycardia Heart Rate - Extreme Tachycardia SPO2 SPO2 - Desat CO2 (Et) CO2 (Fi) CO2 (Resp) P1 / P2 Systolic P1 / P2 Mean P1 / P2 Diastolic BPM BPM BPM Percent Percent mmHg kPa mmHg kPa RPM mmHg kPa mmHg kPa mmHg kPa Adult Pediatric Neo Low Limit 45 20 20 85 80 15 2.0 No low alarm 4 65 8.7 55 7.3 40 5.3 High Limit 160 20 20 Off 80 60 8.0 4 0.5 40 190 25.3 135 18.0 125 16.7 Low Limit 75 20 20 90 80 15 2.0 No low alarm 4 70 9.3 50 6.7 40 5.3 High Limit 160 20 20 Off 80 60 8.0 4 0.5 40 120 16.0 90 12.0 70 9.3 Low Limit 90 20 20 90 80 30 4.0 No low alarm 30 70 9.3 40 5.3 35 4.7 High Limit 210 20 20 Off 80 45 6.0 4 0.5 70 100 13.3 90 12.0 50 6.7 424AlarmsExpressionMR400InstructionsforUse Vital Sign or Parameter Unit Low Limit Low Limit Low Limit Adult Pediatric Neo NIBP Systolic NIBP Mean NIBP Diastolic Temperature mmHg kPa mmHg kPa mmHg kPa C F High Limit 190 25.3 135 18.0 125 16.7 39.0 102.2 12.0 18.0 3.4 5.0 1.5 2.2 2.3 3.4 4.1 6.1 70 9.3 50 6.7 40 5.3 36.0 96.8 Off Off Off Off Off Off Off Off Off Off High Limit 120 16.0 90 12.0 70 9.3 39.0 102.2 12.0 18.0 3.4 5.0 1.5 2.2 2.3 3.4 4.1 6.1 70 9.3 40 5.3 35 4.7 36.0 96.8 Off Off Off Off Off Off Off Off Off Off High Limit 100 13.3 90 12.0 50 6.7 39.0 102.2 12.0 18.0 3.4 5.0 1.5 2.2 2.3 3.4 4.1 6.1 Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Vol. %

Percent DES (Et), Expired Desflurane DES (Fi), Inspired Desflurane ENF (Et) Expired Enflurane ENF (Fi) Inspired Enflurane HAL (Et) Expired Halothane HAL (Fi) Inspired Halothane ISO (Et) Expired Isoflurane ISO (Fi) Inspired Isoflurane SEV (Et) Expired Sevoflurane SEV (Fi) Inspired Sevoflurane N2O (Fi) Inspired Nitrous Oxide O2 (Fi) Inspired Oxygen

*ForallalarmlimitvaluesthatmaybedisplayedinunitsofkPa,allow+/0.1kPaofvariancetoaccountforroundingerrorthatmay occurwhenconvertingfrommmHgtokPa. No low alarm 18 No low alarm 18 No low alarm 18 Percent 80 80 80 99 99 99 65 8.7 55 7.3 40 5.3 36.0 96.8 Off Off Off Off Off Off Off Off Off Off Measurement Limits and Over / Under Values Inthetablebelow,therangeofvaluesthatcanbemeasuredforavitalsignitemareprovided alongwiththehighandlowvaluesthat,beyondwhich,anoverorunderindicationwillbegiven. Specifically,avaluewillbemarkedasOver(OVR)iftheVSvalueisgreaterthanthegivenover value,andmarkedasUnder(UND)iftheVSvalueislessthanthegivenundervalue. Vital Sign or Parameter ECG ECG ECG SPO2 Numeric Item Heart Rate Heart Rate Heart Rate Heart Rate Units BPM BPM BPM BPM Patient Type Adult Ped Neo All Measurement Range Low 30 30 30 30 High 250 300 300 250 Over / Under Values Under Over 250 300 300 250 30 30 30 30 ExpressionMR400InstructionsforUseAlarms425 Vital Sign or Parameter Numeric Item SPO2 P1 and P2 P1 and P2 P1 and P2 P1 and P2 NIBP NIBP NIBP NIBP NIBP NIBP NIBP NIBP NIBP Temperature CO2 (LoFlo option) CO2 (LoFlo option) CO2 (LoFlo option) CO2 (AGENT option) CO2 (AGENT option) CO2 (AGENT option) AGENT AGENT AGENT AGENT AGENT AGENT AGENT AGENT Bellows Respiration Saturation Systolic Mean Diastolic Pulse Rate Systolic Systolic Systolic Mean Mean Mean Diastolic Diastolic Diastolic Temperature CO2 (Et) CO2 (Fi) Resp. Rate CO2 (Et) CO2 (Fi) Resp. Rate Desflurane (Et & Fi) Enflurane (Et & Fi) Halothane (Et & Fi) Isoflurane (Et & Fi) Sevoflurane (Et & Fi) N2O (Et) N2O (Fi) O2 (Fi) Resp. Rate Listing of Alarms Units

%

mmHg mmHg mmHg BPM mmHg mmHg mmHg mmHg mmHg mmHg mmHg mmHg mmHg C mmHg mmHg RPM mmHg mmHg RPM

%

%

%

%

%

%

%

%

RPM Patient Type All Adult Ped Neo All Adult Ped Neo Adult Ped Neo Adult Ped Neo All All All All All All All All All All All All All All All All Measurement Range Over / Under Values Low 1

-30

-30

-30 30 30 30 30 20 20 20 10 10 10 20.0 0 0 4 0 0 4 0 0 0 0 0 0 0 0 4 High 100 250 250 250 250 270 180 130 255 160 120 245 150 100 44.0 90 90 100 90 90 100 18.0 5.0 5.0 5.0 8.0 100 100 100 150 Under Over none none 250

-30

-30 250 250

-30 250 30 30 270 180 30 130 30 20 255 160 20 120 20 245 10 10 150 100 10 44.0 20.0 none 90 90 none 100 none none 90 90 none 100 18.0 5.0 5.0 5.0 8.0 none none none 150 none none none none none none none none 4 4 Thissectionlistspatientalarmsalphabetically,andtechnicalalarms(INOPs)arrangedbythe sourceoftheINOPandthenalphabetically,irrespectiveofpriority.AllalarmsandINOPsare listedhere;thosewhichcanappearonyourMR400willdependontheinstalledoptions. 426AlarmsExpressionMR400InstructionsforUse VitalSignValueState Avitalsignvalueisconsideredmissing(asindicatedbythreedashes,)whenthevitalsignhas producedavaluesincethemonitorwasturnedon,butcannolongerproduceavalue.Examples ofthevaluesthatcouldbecomemissingduringnormaluse,include:

ECGheartratevalueiftheleadsareremoved. SPO2valueduringNoProbe,ProbeOff,etcetera. Temperaturevalueiftheprobewasremoved. Invasivepressurevaluesifthetransducerisremoved. WhenavaluebecomesmissingduetoanINOP,anINOPalarmwillbepresent.And,apatient alarmduetothemissingvaluewillbepresentaswell.Therefore,thesystemcanhavean INOPalarm,andapatientalarm,activeatthesametimeandfromthesamecause. 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. Patient and INOP Alarms Themeasurementlabelsandabbreviationsforpressure,temperature,SpO2,CO2andanesthetic agentalarmsareexplainedintheindividualchapters.Thefollowingtablecontainsalistingof patientalarmsarrangedbyvitalsignorparameter.Theparametermustbeonfortherespective alarmdetectionstobeenabled;seepage318. Note In the case of missing data (- - -), an alarm will occur only if a valid numeric was previously displayed but can no longer be produced; see page 2-20 for details. From Condition Indication Patient Alarm Extreme Brady Extreme Tachy ECG, SPO2, P1

(or P2) The heart rate measurement has violated the Extreme Bradycardia alarm setting. ECG, SPO2, P1

(or P2) The heart rate measurement has violated the Extreme Tachycardia alarm setting. Violated heart rate value ECG, SPO2, P1

(or P2) The heart rate measurement has violated an alarm limit setting. Red flag in ECG alarm flag area, flashing red heart rate numeric in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Red flag in ECG alarm flag area, flashing red heart rate numeric in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Flashing yellow heart rate numeric in the ECG VS box and in the SPO2 VS box, yellow alarm light, medium priority alarm tone ExpressionMR400InstructionsforUseAlarms427 Patient Alarm From Condition Indication Missing heart rate data ECG, SPO2, P1

(or P2) The heart rate data, once present, can no longer be produced. Over maximum heart rate value ECG, SPO2, P1

(or P2) Under minimum heart rate value ECG, SPO2, P1

(or P2) Desat SPO2 Violated arterial oxygen saturation value SPO2 Missing arterial oxygen saturation data SPO2 The heart rate measurement has violated the upper parameter range. The heart rate measurement has violated the lower parameter range. SPO2 has detected a desaturation event. The arterial oxygen saturation measurement has violated an alarm limit setting. The arterial oxygen saturation data, once present, can no longer be produced. Apnea CO2, AGENT The apnea time delay setting has been exceeded. Violated EtCO2 value CO2, AGENT The end-tidal CO2 measurement has violated an alarm limit setting. Missing EtCO2 data Violated FiCO2 value CO2, AGENT The end-tidal CO2 data, once present, can no longer be produced. CO2, AGENT The fractional inspired CO2 measurement has violated an alarm limit setting. Missing FiCO2 data CO2, AGENT The fractional inspired CO2 data, once present, can no longer be produced. Flashing yellow dashes (- - -) in the heart rate numeric in the ECG VS box and in the SPO2 VS box, yellow alarm light, medium priority alarm tone Flashing red heart rate numeric alternating between OVR and the heart rate value in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Flashing red heart rate numeric alternating between UND and the heart rate value in the ECG VS box and in the SPO2 VS box, red alarm light, high priority alarm tone Red flag in ECG alarm flag area, flashing red SpO2 numeric, red alarm light, high priority alarm tone Flashing yellow SpO2 numeric in the SPO2 VS box, yellow alarm light, medium priority alarm tone Flashing yellow dashes (- - -) in the SpO2 numeric in the SPO2 VS box, yellow alarm light, medium priority alarm tone Red flag in the CO2 or RESP alarm flag area, Flashing red respiration rate numeric, red alarm light, high priority alarm tone Note Apnea alarm flag appears in either the CO2 or the RESP alarm flag area, based on the RESP source. Flashing yellow EtCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Flashing yellow dashes (- - -) in the EtCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone Flashing yellow FiCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Flashing yellow dashes (- - -) in the FiCO2 numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone 428AlarmsExpressionMR400InstructionsforUse Patient Alarm From Condition Indication Violated CO2 respiration rate value CO2, AGENT The CO2 respiration rate measurement has violated an alarm limit setting. Missing CO2 respiration rate data CO2, AGENT The CO2 respiration rate data, once present, can no longer be produced. Depending upon RESP VS box configuration:

Flashing yellow respiration rate numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, or Flashing yellow respiration rate numeric in the RESP VS box, yellow alarm light, medium priority alarm tone And where OVR displayed if the value is greater than the highest specified And where UND if the value is less than the lowest specified (AGENT option only) Depending upon RESP VS box configuration:

Flashing yellow dashes (- - -) in the respiration rate numeric in the CO2 VS box, yellow alarm light, medium priority alarm tone, or Flashing yellow dashes (- - -) in the respiration rate numeric in the RESP VS box, yellow alarm light, medium priority alarm tone Violated invasive blood pressure systolic value P1 (and P2) The P1 (or P2) invasive blood pressure systolic measurement has violated an alarm limit setting. Violated invasive blood pressure mean value P1 (and P2) The P1 (or P2) invasive blood pressure mean measurement has violated an alarm limit setting. Violated invasive blood pressure diastolic value P1 (and P2) The P1 (or P2) invasive blood pressure diastolic measurement has violated an alarm limit setting. Missing invasive blood pressure data P1 (and P2) Violated primary agent Et value AGENT Violated primary agent Fi value AGENT The P1 (or P2) invasive blood pressure data, once present, can no longer be produced. The end-tidal measurement for the primary agent gas has violated an alarm limit setting. The fractional inspired measurement for the primary agent gas has violated an alarm limit setting. Flashing yellow systolic numeric in the P1 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Flashing yellow mean numeric in the P1 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Flashing yellow diastolic numeric in the P1 VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Flashing yellow dashes (- - -) in the systolic, diastolic and mean numerics in the P1 VS box, yellow alarm light, medium priority alarm tone Flashing yellow primary agent Et numeric in the AGENT VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Flashing yellow primary agent Fi numeric in the AGENT VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified ExpressionMR400InstructionsforUseAlarms429 Condition Indication Patient Alarm Violated secondary agent Et value From AGENT Violated secondary agent Fi value AGENT Missing primary and secondary agent data AGENT Violated N2O value AGENT Missing N2O data AGENT Violated O2 value AGENT Violated O2 value Missing O2 data Missing bellows respiration rate data Violated temperature value AGENT AGENT RESP TEMP The end-tidal measurement for the secondary agent gas has violated an alarm limit setting. The fractional inspired measurement for the secondary agent gas has violated an alarm limit setting. The primary and secondary agent data, once present, can no longer be produced. The N2O measurement has violated an alarm limit setting. The N2O data, once present, can no longer be produced. The O2 measurement has violated an alarm limit setting. The O2 measurement is less than 18 percent. The O2 data, once present, can no longer be produced. The bellows respiration data, once present, can no longer be produced. The temperature measurement has violated an alarm limit setting. Missing temperature data TEMP The temperature data, once present, can no longer be produced. Violated non-invasive blood pressure systolic value NIBP The non-invasive blood pressure systolic measurement has violated an alarm limit setting. Flashing yellow secondary agent Et numeric in the AGENT VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Flashing yellow secondary agent Fi numeric in the AGENT VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Flashing yellow dashes (- - -) in the primary and secondary numerics in the AGENT VS box, yellow alarm light, medium priority alarm tone Flashing yellow N2O numeric in the GAS VS box, yellow alarm light, medium priority alarm tone Flashing yellow dashes (- - -) in the N2O numeric in the GAS VS box, yellow alarm light, medium priority alarm tone Flashing yellow O2 numeric in the GAS VS box, yellow alarm light, medium priority alarm tone Flashing red O2 numeric in the GAS VS box, red alarm light, high priority alarm tone Flashing yellow dashes (- - -) in the O2 numeric in the GAS VS box, yellow alarm light, medium priority alarm tone Flashing yellow dashes (- - -) in the respiration rate numeric in the RESP VS box, yellow alarm light, medium priority alarm tone Flashing yellow temperature numeric in the TEMP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Flashing yellow dashes (- - -) in the temperature numeric in the TEMP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Flashing yellow systolic numeric in the NIBP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified 430AlarmsExpressionMR400InstructionsforUse Patient Alarm Violated non-invasive blood pressure mean value From NIBP Condition Indication The non-invasive blood pressure mean measurement has violated an alarm limit setting. Violated non-invasive blood pressure diastolic value NIBP The non-invasive blood pressure diastolic measurement has violated an alarm limit setting. Missing non-invasive blood pressure data NIBP The non-invasive blood pressure data, once present, can no longer be produced. Flashing yellow mean numeric in the NIBP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Flashing yellow diastolic numeric in the NIBP VS box, yellow alarm light, medium priority alarm tone, where OVR displayed if the value is greater than the highest specified or UND if the value is less than the lowest specified Flashing yellow dashes (- - -) in the systolic, diastolic and mean numerics in the NIBP VS box, yellow alarm light, medium priority alarm tone Technical (INOP) Alarms and Other Status Flags ThefollowingtablecontainsalistingoftheINOPandotherstatusalarmflagmessages,locations, toneindications,andwhereapplicablepossiblesolutions. ECG Message, Location, Indication Lead Fail ECG alarm flag area, blue alarm light, INOP alarm tone What to Do An ECG lead (or electrode) required to measure the lead view is faulty or disconnected:

Ensure that the ECG lead cable is connected to the wECG module, and that the wECG module has sufficient battery power. Ensure that each ECG lead cable clip is connected to the Quadtrode electrode contact.

(Examine the ECG VS box for indications of a contact problem, where LL = left leg, LA = left arm, and RA = right arm, and LL, LA, RA, = RL [right leg] or all leads.) Replace the ECG lead cable. Replace the Quadtrode electrode. Notes The error message can be displayed for trace A and/or for trace B. May also be displayed when high DC offsets are present on an input lead. ExpressionMR400InstructionsforUseAlarms431 Message, Location, Indication Lead Saturation ECG alarm flag area, blue alarm light, INOP alarm tone SPO2 Message, Location, Indication Bad Probe SPO2 alarm flag area, blue alarm light, INOP alarm tone Erratic SPO2 alarm flag area, blue alarm light, INOP alarm tone HW Fail SPO2 alarm flag area, blue alarm light, INOP alarm tone Intrfernce SPO2 alarm flag area, blue alarm light, INOP alarm tone Low Perf SPO2 alarm flag area, blue alarm light, INOP alarm tone No Probe SPO2 alarm flag area, blue alarm light, INOP alarm tone What to Do Baseline offset of the ECG input signal is too large for process and display of the waveform. Replace the Quadtrode electrode. Note The error message can be displayed for trace A and/or for trace B. What to Do The SpO2 probe is defective. Replace the SpO2 probe. The SpO2 attachment may be improperly applied or positioned on the patient; or, the probe is faulty. Check the alignment of the clip (or grip) on the patient. Replace the SpO2 probe. If the message persists, contact technical support or authorized service personnel. A hardware or other failure has occurred in the wSpO2 module. Replace the wSpO2 module. If the failure persists, immediately remove the MR400 and the wSpO2 module from service then contact technical support or authorized service personnel, as the system must not be used on any patient requiring SpO2 measurement. Interference due to attachment misalignment or incorrect attachment positioning:

Check the alignment of the clip (or grip) on the patient site. Try a different limb or site. Ensure that the module is placed outside of the MR bore. Reposition the wSpO2 module (see page 6-6. Replace the clip (or grip). Accuracy may be compromised due to low perfusion. The tissue at the SpO2 attachment site may be too opaque, thick or cold. If the clip (or grip) is positioned on a finger, check for long, artificial or polished nails. Remove any nail polish or relocate the attachment if needed. Try another attachment site, like a toe. Try rubbing or warming the limb to stimulate circulation. The SpO2 probe is not attached or is improperly attached to the wSpO2 module. Check the connection of the probe to the module. Reconnect the probe or, if the connection was good, replace the probe. 432AlarmsExpressionMR400InstructionsforUse Message, Location, Indication Noise SPO2 alarm flag area, blue alarm light, INOP alarm tone Non-Pulsat SPO2 alarm flag area, blue alarm light, INOP alarm tone Probe Off SPO2 alarm flag area, blue alarm light, INOP alarm tone Pulse?

SPO2 alarm flag area, blue alarm light, INOP alarm tone Searching SPO2 alarm flag area, blue alarm light, INOP alarm tone Wrong Prb SPO2 alarm flag area, blue alarm light, INOP alarm tone What to Do Excessive patient motion, the MRI scan sequence or electrical interference is causing noise in the SpO2 system:

Stop any 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 in a way that does not expose it to bright ambient light. The detected pulse is too weak for reliable reporting of SpO2 measurements:

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. The SpO2 attachment is not properly applied to the patient. Reposition the clip (or grip) on the patient. Pulse reading is questionable. The SpO2 attachment may not be applied optimally or the tissue at the application site may be too opaque:

Check the alignment of the clip (or grip) on the patient. Try a different limb or site. The SpO2 attachment was just applied or it has shifted position on the patient:

If the clip (or grip) 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 probe. If the message persists, contact technical support or authorized service personnel. The probe attached to the wSpO2 module is not the correct type. Attach the correct probe to the module. CO2 / CO (RESP) / AGENT Message, Location, Indication Check CO2 Sampling Line CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Cal Fail CO2 alarm flag area, blue alarm light, INOP alarm tone What to Do Reduced flow has been detected by the CO2 system. Check the sampling line for pinches or obstructions then clear any pinch or replace if necessary. CO2 failed to calibrate. Retry calibration. If the message persists, contact technical support or authorized service personnel. ExpressionMR400InstructionsforUseAlarms433 Message, Location, Indication CO2 Low Flow CO2 alarm flag area, blue alarm light, INOP alarm tone Check for CO2 Occlusion CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Out Of Range CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Sensor Faulty CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Sensor Over Temp CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Warming Up CO2 alarm flag area, blue alarm light, INOP alarm tone CO2 Zero Required CO2 alarm flag area, blue alarm light, INOP alarm tone Magnetic Field Too High CO2 alarm flag area, blue alarm light, INOP alarm tone HW Fail CO2 alarm flag area, blue alarm light, INOP alarm tone Low O2 AGENT alarm flag area, blue alarm light, INOP alarm tone Motor Speed Error CO2 alarm flag area, blue alarm light, INOP alarm tone What to Do Message may appear when the sampling line is initially connected; allow the a few seconds for the flow to be established. Otherwise, the detected flow rate is 10 percent less than nominal; in this case, check the sampling line for pinches or obstructions then clear any pinch or replace if necessary. If the message persists, contact technical support or authorized service personnel. Detected flow through the sampling line is less than 40 ml/min or the water trap may be full of fluid:

Check the sampling line for obstructions and replace it if necessary. Check the fluid level in the water trap and replace it if necessary. If the message persists, contact technical support or authorized service personnel. The calculation value is greater than the upper CO2 limit. Perform readings to confirm patients physiological condition. If the message persists, contact technical support or authorized service personnel. CO2 bench detected a hardware or sensor error. Cycle AC mains power. If the message persists, contact technical support or authorized service personnel. The CO2 sensor is above the specified operating temperature. Confirm that the MR400 is operating within the required environmental conditions (see Appendix A); if outside the specified range, move the MR400 to an area that is within limits. If the problem persists, stop all monitoring activities and contact technical support or authorized service personnel. CO2 is warming to operating temperature. Allow the process to complete, about 2 minutes. Zero calibration of the CO2 module is needed; see page 7-15 for details. The gauss limit has been exceeded, and the AGENT option can no longer function. Position the MR400 per the product labeling; see page 3-2. CO2 module was not found during initialization. Cycle AC mains power. If the message persists, contact technical support or authorized service personnel. The inspired O2 value has dropped below 18.0 The MR400 is too close to the MR magnet. Ensure that the MR400 has been positioned correctly; see page 3-2. If the message persists, contact technical support or authorized service personnel. 434AlarmsExpressionMR400InstructionsforUse Message, Location, Indication Multiple Agents AGENT alarm flag area, blue alarm light, INOP alarm tone O2 Sensor Not Present AGENT alarm flag area, blue alarm light, INOP alarm tone Occlusion CO2 alarm flag area, blue alarm light, INOP alarm tone O2 Sensor Fail CO2 alarm flag area, blue alarm light, INOP alarm tone Occlusion at Start CO2 alarm flag area, blue alarm light, INOP alarm tone Performing CO2 Zero CO2 alarm flag area, blue alarm light, INOP alarm tone Persistent CO2 Occlusion CO2 alarm flag area, blue alarm light, INOP alarm tone P1 (or P2) Message, Location, Indication Catheter Disconnected P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone Hardware Error P1 (or P2) alarm flag area, blue alarm light, INOP alarm tone What to Do More than one anesthetic agent gas was detected in a given breath phase, with a total MAC of the detected mix is less than 3 MAC. Note If multiple agents have been detected with a total MAC of the detected mix greater than 3 MAC then this message will be accompanied by a yellow alarm light and medium priority alarm tone. Possible hardware failure associated with the O2 sensor. Ensure that the O2 sensor is secure in the receptacle; see page 14-13. If the message persists, contact technical support or authorized service personnel. Occluded sample line detected at start up:

Check the sampling line for obstructions and replace it if necessary. Check the fluid level in the water trap and replace it if necessary. If the message persists, contact technical support or authorized service personnel. O2 sensor has failed or expired. Replace the O2 sensor; see page 14-13. If the message persists, contact technical support or authorized service personnel. Occluded sample line detected at start up:

Check the sampling line for obstructions and replace it if necessary. Check the fluid level in the water trap and replace it if necessary. If the message persists, contact technical support or authorized service personnel. Displayed while zeroing CO2. Allow the process to complete. Reduced CO2 flow has been detected for over 2 minutes. Check for pinches or obstructions in the sampling line. Clear any pinch, or replace the accessory if necessary. If the message persists, contact technical support or authorized service personnel. What to Do The catheter cannot be detected. Check all catheter connections to and from the transducer. A hardware error has been detected in the IBP system. Contact technical support or authorized service personnel. ExpressionMR400InstructionsforUseAlarms435 Message, Location, Indication Transducer Faulty P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone Transducer Not Present P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone TEMP Message, Location, Indication Cal Error TEMP alarm flag area, blue alarm light, INOP alarm tone Chk Probe TEMP alarm flag area, blue alarm light, INOP alarm tone Exp Probe TEMP alarm flag area, blue alarm light, INOP alarm tone HW Fail TEMP alarm flag area, blue alarm light, INOP alarm tone No Probe TEMP alarm flag area, blue alarm light, INOP alarm tone Wrong Prb TEMP alarm flag area, blue alarm light, INOP alarm tone What to Do Check the transducer cable connection. Replace the transducer. Contact technical support or authorized service personnel if the message persists. A electrical transducer malfunction has been detected. An IBP transducer was not found. Ensure that the transducer cables are connected to the transducer and MR400. If the message persists, contact technical support or authorized service personnel. What to Do Calibration error. Reconnect the sensor and then retry. Contact technical support or authorized service personnel if the message persists. The temperature sensor connection is bad, has a sharp bend, or is damaged:

Ensure that the sensor is inserted completely in the temperature port on the patient connection panel. Remove any sharp bends in the temperature sensor. If the message persists after performing the above actions, then the temperature sensor most likely is damaged and readings cannot be provided. Try a new sensor. The temperature probe connected to the MR400 is not the proper type. Insert the correct type of temperature probe into the temperature port. Temperature hardware failure detected. Contact technical support or authorized service personnel. The temperature probe is not properly connected to the MR400. Insert a temperature probe into the temperature port on the patient connection panel. The temperature probe connected to the MR400 is not the proper type. Insert the correct type of temperature probe into the temperature port. 436AlarmsExpressionMR400InstructionsforUse NIBP Message, Location, Indication Communication Error NIBP alarm flag area, blue alarm light, INOP alarm tone Deflation Timeout NIBP alarm flag area, red alarm light, high priority alarm tone Hardware Error NIBP alarm flag area, blue alarm light, INOP alarm tone Inflation Timeout NIBP alarm flag area, blue alarm light, INOP alarm tone Measurement Failed NIBP alarm flag area, blue alarm light, INOP alarm tone Measurement Timeout NIBP alarm flag area, blue alarm light, INOP alarm tone Module Not Calibrated NIBP alarm flag area, blue alarm light, INOP alarm tone Over Pressure NIBP alarm flag area, blue alarm light, INOP alarm tone Pressure Correction NIBP alarm flag area, blue alarm light, INOP alarm tone Residual Pressure NIBP alarm flag area, blue alarm light, INOP alarm tone What to Do An internal NIBP error has occurred. Discontinue use of NIBP and contact technical support or authorized service personnel. Cuff deflation has timed out; displayed if the NIBP cuff deflation period is greater than 80 seconds

(neonatal patient type) or is greater than 150 seconds (adult and pediatric patient types):

Check the patient. Check for proper cuff size and placement. Check the cuff and hoses for pinching. If the message persists, contact technical support or authorized service personnel. NIBP hardware failure detected. Discontinue use of NIBP and contact technical support or authorized service personnel. Cuff inflation has timed out:

Check the patient. Check the cuff and hoses for pinching or leaks. If the message persists, contact technical support or authorized service personnel. The NIBP measurement has failed:

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 or authorized service personnel. 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. Check the cuff condition and placement on the patient. NIBP is not calibrated. Contact technical support or authorized service personnel. The allowed pressure for the type of patient has been exceeded:

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 or authorized service personnel. A pressure correction error has been detected:

Ensure that the patient is immobilized and not applying pressure to the cuff. Check the cuff condition and placement on the patient. Residual pressure remains in the NIBP system. Disconnect the NIBP hose from the patient connection panel and then restart the procedure. ExpressionMR400InstructionsforUseAlarms437 Other Status Indications Message, Location, Indication All Alarms Are Off System message area, no alarm light, no alarm tone Audio Off System message area, no alarm light, no alarm tone Audio Paused System message area, no alarm light, no alarm tone Change NIBP Cuff System message area, no alarm light, no alarm tone Check Alarm Vol System message area, no alarm light, no alarm tone Condition All alarm limits have been turned off. Alarm sound is silenced. Alarm sound is paused. The Patient Type was changed so the NIBP cuff should be changed. Power was just turned on, settings were recalled. The charge level is low for the wECG module battery (or batteries). Install at least one charged battery into the wECG module. WARNING A red battery symbol indicates that the module batteries have fallen below the required operational output and module shutdown with loss of monitoring will occur. Immediately replace the module batteries to avoid a loss in monitoring. No communication between the MR400 and wECG module. Ensure that the wECG module is set to the same network channel as the MR400 cart. If both are the same, use an alternate setting. If the indication persists, contact technical support or authorized service personnel. The ECG Test Signal is on. No communication between the MR400 and IP5. Ensure that the IP5 is set to the same network channel as the MR400 cart. If both are the same, use an alternate setting. If the indication persists, contact technical support or authorized service personnel. status information pane, blue alarm light, INOP alarm tone Status information pane, no alarm light, no alarm tone ECG Test Signal System message area, no alarm light, no alarm tone Status information pane, no alarm light, no alarm tone 438AlarmsExpressionMR400InstructionsforUse Message, Location, Indication Condition Charge level of the cart batteries is low. Connect the MR400 cart to external power and allow the batteries to charge. WARNING A red battery symbol indicates that the main batteries in the MR400 have fallen below the required operational output and system shutdown with loss of monitoring will occur. Immediately locate an AC outlet and connect the MR400 to avoid a loss in monitoring. The size of the ECG waveform is too large and the tops of the ECG waveforms are clipped (that is, cut off). Reduce the size using the Scale setting; see page 5-28. Normal audio sounds are suspended as a volume adjustment is in progress. The system is in simulation mode. Turn off power to exit this mode. Charge level of the wSpO2 module battery is low. Install a charged battery into the wSpO2 module. WARNING A red battery symbol indicates that the module batteries have fallen below the required operational output and module shutdown with loss of monitoring will occur. Immediately replace the module batteries to avoid a loss in monitoring. No communication between the MR400 and wSpO2 module. Ensure that the wSpO2 module is set to the same network channel as the MR400 cart. If both are the same, use an alternate setting. If the indication persists, contact technical support or authorized service personnel. Status information pane, blue alarm light, INOP alarm tone Overscale ECG alarm flag area, no alarm light, no alarm tone Real Tones Disabled System message area, no alarm light, no alarm tone Simulation System message area, no alarm light, no alarm tone Status information pane, blue alarm light, INOP alarm tone Status information pane, no alarm light, no alarm tone ExpressionMR400InstructionsforUseAlarms439 440AlarmsExpressionMR400InstructionsforUse CHAPTER 5 Monitoring ECG Electrocardiogram(ECG)monitoringinsidetheMRIenvironmentisuniqueandrequires additionalprecautionstopermitsafepatientprocedures.Itisalwaysimportanttoremember thattheriskofradiofrequency(RF)heatingiseverpresentwhenanyelectricalconductors(for example,ECGleadcables)areplacedintheMRsystembore.Byfollowingtheoperating precautions,warningsandtheguidelinesbelow,theseriskscanbeminimized.TheECG parameterisintendedforECGmonitoringmodeandnotdiagnosticECGmonitoring. WARNINGS The MR400 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 MR400 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. ECG Monitoring Considerations for the MR Environment MonitoringECGintheMRenvironmentisparticularlychallengingbecauseoftheinherent distortionoftheECGwaveformcausedbythecombinedelectromagneticfieldsgeneratedbythe MRIscanner.Inparticular,certainECGinterferenceappearswhenthepatientisplacedinsidethe borebeforescanningbegins.ThesebloodflowinduceddistortionsoftheECGareduetothe largeamountofbloodmovingthroughthevesselsoftheheart(aorta).Blood(averygood electricalconductor)movingthroughthelargemagneticfieldoftheMRproducesanelectrical potentialthataddstotheECGsignal.Thisinducedelectricalpotentialisseenprimarilyasan augmentationoftheECGTwaveamplitude,althoughothernonspecificwaveformchangesare alsoapparentontheECG.SinceanelevatedTwaveorSTsegmentwillbeassociatedwithtrue physiologicdisorders,thestaticmagneticfieldinducedECGdistortionsmayprohibiteffective ECGmonitoringintheMRI.Forthisreason,abaselinerecordingoftheECGpriortoslidingthe patientinsidetheboreoroutsidetheMRmagnetroomwillbenecessary. ExpressionMR400InstructionsforUseMonitoringECG51 TheproperplacementoftheECGelectrodesintheMRIiscriticaltoreducingthebloodflow induceddistortionoftheECGwaveform.WithproperstrategicplacementoftheECGelectrodes andminimizationofECGleadcablelength,thisbloodflowinduceddistortioncanbekepttoa minimum,asdiscussedinthissection.Additionalartifactscausedbythestatic,gradientandRF electromagneticfieldscanseverelydistorttheECG,makingobservationofthemorphologic changesanddetectionofarrhythmiaquitedifficult.MonitoringusingadifferentECGleadview(I, II,III,AVL,AVR,AVF)willminimizesomeoftheseartifacts. wECG Module and ECG Lead Cable ThewECGmoduleandleadcableareintendedforpatientuseswhencontinuousECGmonitoring orcardiacgatingarerequired.ThewECGmoduleandleadcablemaybeusedintheMRsystem bore,althoughthemodulemustnotbeplacedwithin28cm(11inches)oftheMRIfieldofview

(FOV).ForwECGmoduledetails,seepage29.ThecomponentsoftheECGleadcablearedetailed below. 1 2 3 4 5 6 1 2 3 4 5 6 Connector ECG lead cable label identifier Velcro storage strap Cable trunk with foam insulator Lead wires Lead cable clips If dropped, the wECG module must be verified for correct operation before use; see page 14-12. Guard against the accidental ingress of liquid into the module, as measurements made by the device can be adversely affected. CAUTIONS 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. 52MonitoringECGExpressionMR400InstructionsforUse Quadtrode Electrodes TheQuadtrodeelectrodesserveaspatientconnectionpointsfor theECGleadcableclips.DifferentQuadtrodeelectrodesare availabletomeeteachmonitoringrequirement.The componentsofaQuadtrodeelectrodearedetailedbelow. 1 1 2 3 Foam insulator Electrode contact (four contacts are provided on the standard and neonatal types, and one contact on the CV type Lead retainer (not present on CV and neonatal types) 2 3 Work Flow for ECG Monitoring WhenmonitoringECG,manyfactorswillimpacttheperformanceandoperationofthe parameter,including:

Thesiteselectedonthepatient, TheECGleadcableandQuadtrodeelectrodepairing, Theselectedfilterandleadviewsettingforthemonitor, ModuleplacementandECGleadcablerouting;and, ScansequenceselectionandscansequenceparametersontheMRIconsole. ToprepareapatientforECGmonitoring Step 1 Action SelectthePatientType. SeeSelectingthePatientTypeonpage311. Accordingtothepatienttype,theirbodymass,andthestudytobe performed,choosearecommendedECGleadcableandQuadtrode electrodepair. SeeSelectingtheECGLeadCableandQuadtrodeElectrodeTypeon page55. DecidewheretoapplytheQuadtrodeelectrodetothepatient. 2 3 SeeIdentifyingthePlacementSitefortheQuadtrodeElectrodeon page57. ExpressionMR400InstructionsforUseMonitoringECG53 Step 4 Action Preptheplacementsite(s)onthepatientandthenapplythe Quadtrodeelectrodetothepatient. 5 6 7 8 9 10 SeePreparingtheQuadtrodeElectrodeSiteonpage511. AttachtheleadcableclipstothecontactsontheQuadtrode electrode. SeeAttachingtheECGLeadCableonpage512. EvaluatetheECGsignalstrengthandmakeadjustmentsasneeded beforethepatiententersthescanner. SeeCheckingtheECGSignalStrengthonpage516. Positionthepatient,theleadcableandthewECGmodulefor scanning. SeePositioningtheECGLeadCableandwECGModuleforScanning onpage519. SelecttheleadviewandFilterModeforthestudy. SeeChangingtheLeadViewonpage517andFilterModeonpage 531. Beforeslidingpatientinsidethebore,oroutsidetheMRmagnet room,establishabaselinerecordingofthepatientsECGsignal. Slidethepatientintothebore,butdonotstartscanning.Then, rechecktheECGwaveformforusabilitybyevaluatingitfor distortion. IfECGwaveformhasbecomeexcessivelydistortedandtheheart ratenumericisnotfunctioningproperlyinthebore,thentheECG leadcablemayrequirereroutingand/oranewelectrode placementsitemustbeselectedbeforestartingthescansequence.

(AlsoseeMinimizingECGWaveformNoiseonpage518.) 54MonitoringECGExpressionMR400InstructionsforUse Step 11 Action BeginscansequenceandobservetheECGwaveform. IftheECGwaveformbecomescompromisedduringscanning,then changetheleadviewand/ortheFilterModeontheMR400. Note ECG performance during MRI scanning can be further improved by modifying scan sequence parameters at the MRI console. Changing any of these parameters directly alters image quality so precaution must be taken to not overwhelmingly affect the desired image characteristics:

Increase TE (Echo Time) Increase TR (Repetition Time) Increase TI (Inversion Time) Increase / change the imaging plane (for example, sagittal to axial) Turn off fat suppression Decrease the PNS level Decrease the gradient strength 12 Afterscanning,disconnectthewECGmodulefromthepatient. ThenstorethewECGmoduleinthemoduleholder.Loopthecable trunkwithfoaminsulatorthensecureitusingtheVelcrostorage straptokeeptheexcesscablelengthfromtouchingthefloor;see page212. Selecting the ECG Lead Cable and Quadtrode Electrode Type ECGleadcablesandQuadtrodeelectrodesareprotonemissionscompliant,willnotdistortthe MRimage,andaredesignedtoprovidethemaximumpatientsafetyandMRIperformance:

OnlyusethespecifiedECGleadcableswiththeMR400,asthesearespeciallyconstructed toavoidpatientheatingbyreducingtheamountofradiofrequency(RF)energythatcan flowthroughthewiresandwithashorterlengthtoreducethepotentialforcablelooping. ThetypeofleadcableneededwilldependuponthetypeofQuadtrodeelectrodebeing used. OnlyusethespecifiedQuadtrodeelectrodewiththeMR400,asthiswillminimizethe possibleriskofelectrodeheatingduringMRIproceduresandreducetheamountofMRI generatedartifactsontheECGwaveform.ThetypeofQuadtrodeelectrodeneededwill dependgenerallyuponthepatienttype,genderandweight.(Regardlessofthetype,the Quadtrodeelectrodewillbeconsideredasingleitemwhendiscussedinthistext.) ExpressionMR400InstructionsforUseMonitoringECG55 ThetablebelowhighlightstherecommendedusesofECGleadcablesandQuadtrodeelectrodes. ECG Lead Cables and Quadtrode Electrodes - Recommended Pairings CV ECG lead cable CV Quadtrode Electrode Purpose:

Best for female and overweight patients (that is, in situations where placement For patients weighing more than 10 kg (22 pounds) would be difficult using the standard Quadtrode electrode) Version and Part Number:

AAMI: REF 989803193721 IEC: REF 989803193751 Standard ECG lead cable Purpose:

Quick application For patients weighing more than 10 kg (22 pounds) Version and Part Number:

AAMI: REF 989803193731 IEC: REF 989803193761 Neonatal ECG lead cable Purpose:

Quick application For infants weighing less than 10 kg (22 pounds) Version and Part Number:

AAMI: REF 989803193741 IEC: REF 989803193771 Part Number:

REF 989803179041 Quadtrode Electrode

(standard) Part Number:

REF 989803179031 Neonatal (Neo) Quadtrode Electrode Part Number:

REF 989803179051 56MonitoringECGExpressionMR400InstructionsforUse Identifying the Placement Site for the Quadtrode Electrode Warning WARNING Ensure that the location of the electrodes is compliant to the requirements of your electrosurgical equipment to reduce the possibility of burns; however, note that monitoring in the MR environment requires specific electrode placement. (See page 5-3 to ensure the highest quality ECG signal. For questions and guidance regarding placement, contact technical support; see page 14-16 for contact information.) Accordingtothepatienttypeorweight,placementoftheQuadtrodeelectrodeovertheheartis importantforoptimalECGperformance. Note For placement purposes, we define to the breast line as an imaginary horizontal line that extends across the nipple areas of a patient of normal weight. Adultandpediatricpatients:

IfusingastandardQuadtrodeelectrode,placeitslightlytotheleftofthepatients sternum,withthetoptwoelectrodesonthebreastlineandthebottomtwoelectrodes belowthebreastline. IfusingaCVQuadtrodeelectrode,attempttokeepasmallseparationbetweenindividual electrodesadistancethatiswideenoughtoproperlycapturetheECGvector,butnotso wideastocauseexcessivenoisepickup.(Increasingtheloopareabetweenelectrodeshas anegativeeffectonECGqualityuniquetotheMRIenvironmentthatcausesmorenoiseto bepickedupbytheECGleads). Neonatalandinfantpatients:

Dependingonthepatientsweight,centerastandardQuadtrodeelectrodeoraneonate Quadtrodeelectrodeoverthesternumandthebreastline. DeviationsfromtheguidelinesforQuadtrodeelectrodeplacementcanaffecttheproducedECG signalasfollows:

Placementsoffsetabovethebreastline:IncreasestheTwaveamplitudeandthe susceptibilitytostaticfield(B0)effects. Placementsoffsetbelowthebreastline:DecreasestheTwaveamplitude,increasethe distancefromtheaorticvalve,thesusceptibilitytostaticfield(B0)effectsandtheECG waveamplitude. Placementsclosertothesternum:IncreasestheECGwaveamplitudeandalsoany respirationinducednoise. Placementsfartherfromthesternum:DecreasestheECGwaveamplitudeandany respirationinducednoise. ExpressionMR400InstructionsforUseMonitoringECG57 ThediagramsbelowillustrateQuadtrodeelectrodeplacementsite(s)accordingtopatienttype, includingthepreferredQuadtrodeelectrodetypeandlocationfordifferentpatientbodysizes. Selectingsitesonadultfemalepatients Average weight adult female*

Overweight adult female*

CV Quadtrode Preferred CV Quadtrode Preferred Standard Quadtrode Standard Quadtrode

*Where grayed images indicate placement sites against the ribcage under the breast. 58MonitoringECGExpressionMR400InstructionsforUse Selectingsitesonadultmalepatients Average weight adult male Overweight adult male*

CV Quadtrode CV Quadtrode Preferred Standard Quadtrode Preferred Standard Quadtrode

*Where the grayed image indicates a placement site against the ribcage under the breast. ExpressionMR400InstructionsforUseMonitoringECG59 Selectingsitesonpediatricpatients Pediatric female CV Quadtrode Pediatric male CV Quadtrode Standard Quadtrode Preferred Standard Quadtrode Preferred 510MonitoringECGExpressionMR400InstructionsforUse Selectingsitesoninfantsandneonatalpatients Infants and Neonates Standard Quadtrode Neonatal Quadtrode Preparing the Quadtrode Electrode Site ProperpreparationfortheapplicationoftheQuadtrodeelectrodeiscriticaltoECGperformance. TheresultofpoorapplicationpreparationwillbepoorECGmonitoringperformance.Ifelectrode contactwiththeskinispoor,thenremoveanddiscardtheQuadtrodeelectrode,andrepeatthe sitepreparationprocessagainaccordingtotheinstructionsbelow.NeverreuseaQuadtrode electrodebecauseitwillnotsecurelyadheretotheskin. ToprepareaQuadtrodeelectrodesiteonapatient Step 1 2 Action ChecktheexpirationdateoftheQuadtrodeelectrodepackage. Selecttheapplicationarea(s),avoidingtheareolaandnipplewhen possible,fortheQuadtrodeelectrodesite(s)asprovidedonpage5 7. ExpressionMR400InstructionsforUseMonitoringECG511 Step 3 4 5 6 7 Action Ifnecessary,shavetheapplicationareatoremovehairfromthe selectedQuadtrodeelectrodesite(s). ApplyECGSkinPrepGel(REF989803152291)toagauzepad. Brisklyrubtheselectedsite(s)withthegauzepad(theskinmay turnpink). Removeanyexcessgelwithacleangauzepad. PlacetheQuadtrodeelectrodeatthepreparedsite(s)onthe patient. 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. 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. Attaching the ECG Lead Cable 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. An ECG lead cable that becomes 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 E to prevent excessive heating associated with MRI procedures. Follow steps to minimize the risks of MRI-related heating on page 5-

20. Giveninrelationtothepatientslimbs,designatorsandcolorsoftheECGleadcableclips referenceconnectionlocationsontheQuadtrodeelectrode.Also,notethatdependinguponthe leadcableversion,AAMI(AssociationfortheAdvancementofMedicalInstrumentation)orIEC

(InternationalElectrotechnicalCommission),differentdesignatorsandcolorsareusedforthese references.ThediagramsbelowillustratetheleadcableattachmentlocationstotheQuadtrode, accordingtotheECGleadcableversionandlimb. 512MonitoringECGExpressionMR400InstructionsforUse AAMI ECG Lead Cable Connections IEC ECG Lead Cable Connections AAMI ECG Lead Cable Clip Designator / Color RA / White RL / Green LA / Black LL / Red IEC ECG Lead Cable Clip Designator and Color R / Red N / Black L / Yellow F / Green Associated Limb Right arm Right leg Left arm Left leg CAUTION ECG lead cable clips should not be placed on the patients extremities. ToattachtheECGleadcabletothewECGmoduleandthentotheQuadtrodeelectrode contacts Step 1 Action InserttheconnectoroftheECGlead cableintothecableportonthewECG module. CAUTION When inserting or removing the lead cable, only use the connector as a finger-hold; never pull or apply excessive force to the wires. ExpressionMR400InstructionsforUseMonitoringECG513 Step 2 Action DependingupontheECGleadcabletype,attachtheclipstothe Quatrodeelectrodecontacts,asshownintheappropriate connectiondiagramonpage512.Squeezeeachclipopenthen placetheclipontotheelectrodecontactandrelease. CAUTION When inserting or removing the clip leads, use the clip as the finger-

hold; never pull or apply excessive force to the wires. 3 4 5 6 7 IfusingastandardQuadtrodeelectrode,securetheleadcable wiresusingtheleadretainer. Seepage53forthelocation. CheckthebatteryindicatorsonthewECGmoduletoensurethat enoughchargeexistsinatleastoneoftheinstalledbatteries:

Greenbatteryindicator=Chargesufficient;proceedtostep6. Redbatteryindicator=Chargelow;proceedtostep5. Seepage29fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) Accordingtotheredbatteryindicator(s)presentonthewECG module,insertachargedmodulebatteryintothecorresponding batterybay(s)andthenrecheckthebatteryindicator(s)toensurea sufficientchargebeforeproceeding;seepage124. CheckthenetworkchannelindicatoronthewECGmoduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep8. Flashing=Nocommunication;proceedtostep7. Seepage210fordetails.(Also,youcanreferencethestatus informationpane;seepage216.)AninoperativeECGparameteror wECGmoduleisindicatedbyabsenceofanECGwaveformanda simultaneousLeadFailalarm. EnsurethatthewECGmoduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129. 514MonitoringECGExpressionMR400InstructionsforUse Step 8 Action EnsurethattheECGsignalhasthenecessaryamplitudebychecking thedisplayedwaveform;seeCheckingtheECGSignalStrengthon page516. IfLeadFailisdisplayed,seepage515fortroubleshootingdetails;

or,ifLeadSaturationisdisplayed,replacetheQuadtrode electrode,seepage511. Note During a Lead Fail condition, if the HR Source is set to ECG, then no HR measurement numeric will be displayed in the ECG and SPO2 VS boxes; see page 5-15 for an example. 9 KeepthemoduleoutsidetheMRsystemborebyplacingitinone ofthetwolocationsshowninPositioningtheECGLeadCableand wECGModuleforScanningonpage520. Lead Fail Indication LeadFail(illustratedbelow)isanINOPalarmthatwillbedisplayedwhentheECGtracecanno longerbeproducedbecauseoneoftheelectrodesrequiredformeasurementisdisconnected eitheranelectrodecameoffofthepatient,anECGleadcableclipcameoffoftheelectrode,ora wireintheECGleadcablehasfailed.DependingupontheTraceALead(orTraceBLead)setting

(seepage527),theelectrodefaultindicator(s),LL,LA,orRA,maybedisplayedintheECGVSbox

(seetheexamplebelow);seepage431formoreinformation. Warning WARNING Failure to respond to a Lead Fail alarm will result in a lapse of patient monitoring. 1 2 1 2 Lead Fail message indication Electrode fault indication, example ExpressionMR400InstructionsforUseMonitoringECG515 Checking the ECG Signal Strength EvaluatetheECGsignalproducedbythepatientbeforeentryintotheMRIscanner,the optimumtimetocorrectanyproblem. Aminimumsignalstrengthshouldbepresent,asweakersignalsmaybepronetogradient interference:

SelectScaletoadjustthedisplayedsizeofthewaveform(s),wherethescaleindicator provides,a1millivolt(mV)referenceatanygivensetting;seeSelectingtheScale,below). Scale indicator QRS complex SelectTraceALead(orTraceBLead)toadjusttheconfigurationoftheleadsusedforECG signaldetection,wherethebestsignalstrengthisindicatedbythedisplayedpeaktopeak amplitudeoftheQRScomplex,whichshouldbeatleast1mV(thatis,thewaveform shouldbeequaltothesizeofthescaleindicator).Insomecases,a1mVECGsignalcannot beachievedduetopatientphysiology.Inthesecases,trytoachievethelargestamplitude attainable.SeeChangingtheLeadView,onpage517. Selecting the Scale TheScalesettingonlychangeshowtheECGtraceappearsonthescreenincreasingor decreasingthewaveformandanyartifacts.ToincreasetheamplitudeoftheQRScomplex,refer toChangingtheLeadViewonpage517. TochangetheSCALEsetting Step 1 2 3 Action EnsurethatthecorrectPatientTypehasbeenselected;seepage3 11fordetails. SelecttheECGVSbox. TheECGmenuappears.Currentsettingsaredisplayed. SelectScale. TheScalemenuappears;seepage528. 516MonitoringECGExpressionMR400InstructionsforUse Step 4 Action Selectthesetting.Onlyasettingof5xor10xisrecommended. Auto 1x 5x 10x 15x 20x 25x 30x 40x 5 Thesettingisapplied. Takenoteofthescaleindicator;seepage522.Iftheselectedscale resultsinanECGtracesolargethatthewaveformpeaksare distortedorclipped,Overscalewillbedisplayed.Inthiscase,select anothersettingtoresizethewaveformuntilthemessagestops. Changing the Lead View IftheQRScomplexdoesnotequalaminimumof1mVpeaktopeak,thencompletethe followingstepstomakethewaveformamplitudeincrease. Tochangetheleadview Step 1 2 3 4 5 Action VerifythataQuadtrodeelectrodeorQuadtrodeelectrodesare beingused,andverifytheexpirationdate,qualityandpackaging fortheelectrode. EnsurethatthepreferredQuadtrodeelectrodeisbeingused;see page55. Ensurethatthesuggestedplacementsite(orsites)isbeingused;

seepage57. SelecttheECGVSbox. TheECGmenuappears.Currentsettingsaredisplayed. Dependinguponthetracebeingexamined,selectTraceALeador TraceBLead. Therespectivemenuappears.Thecurrentsettingishighlighted. ExpressionMR400InstructionsforUseMonitoringECG517 Step 6 Action Selectthedesiredleadviewsetting. I II III AVL AVR AVF Thesettingischanged. Note When presented with poor gating or heart rate performance, it may be necessary to use the Pediatric ECG setting; see page 5-32. 7 8 Iftheamplitudedidnotimprove,repeatstep5andcyclethrough theremainingleadviewsettingsuntila1mVsignalamplitudeis attained. Iftheamplitudedidnotimprove,removetheECGleadcableand theQuadtrodeelectrode.Thenpreptheapplicationsiteagainand applyanewQuadtrodeelectrode. Minimizing ECG Waveform Noise NoisecanrenderanECGwaveformunusable,asshownintheexamplebelow. ManycausescanresultinanoisyECGwaveform,including:

Useofalcoholbasedproductsduringpatientprep. UseofaQuadtrodeelectrodethatisexpiredordriedout. UseofwrongordamagedECGcableleads. ImproperplacementoftheQuadtrodeelectrode. PlacingtheMR400insidethe5000gaussline. PlacingthewECGmoduleinsidethebore. MRvibrationsaffectingthewECGmodule. Incorrectnotchfiltersetting;seepage522. 518MonitoringECGExpressionMR400InstructionsforUse SelectingMonitorastheFilterModeforthescansequence;seepage531. Scansequenceparameters. ImproperconnectionofECGleadcabletoQuadtrodeelectrodecontactlocations. RoutingtheECGleadcableadjacenttothebodycoilorunderneathanextremitycoil. ExcessivedistancebetweenelectrodeswhenusingCVQuadtrodeelectrodes. Positioning the ECG Lead Cable and wECG Module for Scanning WARNINGS When applying electrodes or connecting the ECG 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, et cetera) 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 probes are placed in the bore with the patient. Mixing of conductors from various manufacturers (catheters, temperature sensors, et cetera) 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, et cetera. 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, et ceteraincluding NIBP cuffs and hoses, EtCO2 and/or oxygen air-lines, and SpO2 probescan be used safely as these items do not include electrically conductive materials. The MR400 has been validated for use with all accessories specified in the accessory list; see page 1-33. Circular, U-shaped or S-shaped loops in the ECG lead cable should be avoided to reduce the risk of heating. Do not use the Velcro storage strap to loop the ECG lead cable during MR scanning;

otherwise, there is a risk of cable heating and possibly skin burns. ExpressionMR400InstructionsforUseMonitoringECG519 PositioningtheECGleadcable PositionandkeeptheECGleadcablesinastraightline.Never allowtheECGleadcablestotouchtheMRsystembore.Any loop(circular,Ushaped,Sshaped)inthecablesorcable contactwiththeMRsystemborewillcauseheatinginthe cablesorinthepatientelectrodes.Followthestepsbelowto minimizethecableheatingrisk. TominimizetheriskofMRIrelatedheating Step 1 2 3 4 5 6 7 8 Action ArrangetheECGleadcableandtheclipleadsneatly,inastraight alignment,withnolooping. Avoidcontactbetweencablesandbareskin.CushionthewECG module. UseonlytheECGleadcablesdesignatedforusewiththisproduct;

seepage135. Minimizetheuseofmultiplecables.(Seethewarningsonpage5 19fordetails.) ThewECGmodule,ECGleadcablesandQuadtrodeelectrodeare acceptableforusewithinMRsystemswithstaticmagneticfield strengthsof3.0TeslaorlesswithintheMRsystemboreusingaMR systemreportedwholebodyaverageSpecificAbsorptionRates

(SAR)upto4.0W/kg.EnsurethatB1rms<7.2T. MonitoringofECGatpowerlevelsofgreaterthanaMRsystem reported,wholebodyaveragedSARof4W/kgisnotrecommended forthegeneralpatientpopulation.Suchmonitoringmustonlybe attemptedwithconsciouspatientswithnormalthermoregulatory capabilitiessothattheymaywarnyouofpossibleexcessiveheatat themonitoringsites. Usecautionforscantimes(thatis,perpulsesequence)greater than15minutes.ForMRIscanswithaverageSAR>1W/kg,limit scantimeto15minutesandpauseatleast3minutesbetween scanstoallowtheECGelectrodestocool. Duringmeasurement,checkthepatienttoensurethatMRIrelated heatingisnotoccurring. 520MonitoringECGExpressionMR400InstructionsforUse PositioningthewECGmodule Warning WARNING The wECG module must be kept outside the system bore or image distortion may result. This is a result of proton emissions from the ECG module. Dependinguponyourregionofinterest(ROI)andthelargestfieldofviewbeingexamined(see illustrationbelow),followtheseguidelinestoensurethebestperformanceofthewECGmodule, especiallyduring harshscansequences:

Forstaticfield(B0)compliance,keepthemoduleatleast28cm(11inches)outsidethe MRIfieldofview. Consideringthescantobeperformed,placethemoduleonornearthepatientandas closetotheboreisocenteraspossible. Placethemoduleasclosetotheboreopeningaspossible.(Ifthemodulecanbeplaced outsidethebore,positioningattheboreisocenterisnotnecessary.) PlacethemoduleonacushionedsurfacetominimizeMRvibrations. Male:

Bore Iso-center ROI Patient Table MRI Bore Bore Iso-center Male:

Largest FOV

(45 cm) Patient Table MRI Bore For B0 compliance always keep the wECG module 28 cm from the edge of the FOV. For example, a lower abdomen scan places the module at an acceptable distance of 30 cm (considering the length of the ECG cable) s e i r e S R X T 0 3 a v e h c A i

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:

e p y t t e n g a M ExpressionMR400InstructionsforUseMonitoringECG521 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. Selecting the Filter Mode ChoosetheappropriateECGfiltermodeforyourMRIstudy;seepage531formodedetails. Tochangethefiltermodesetting Step 1 Action PresstheECGFilterkey. TheFilterModemenuappears.Thecurrentsettingishighlighted. Selectthedesiredfilter. 2 Monitor Default Advanced1 Advanced2 Thesettingisapplied,asindicatedinECGVSbox. ECG Waveforms and VS Box TheECGmeasurementisdisplayedaswaveformsintheVStraceareaofthescreenandas numericinformationintheECGVSbox.Otherdata,includingECGrelatedalarminformation,are alsoprovidedinthisareaofthescreen,asdetailedbelow. 522MonitoringECGExpressionMR400InstructionsforUse 15 14 16 13 1 12 2 3 4 5 6 7 8 9 11 10 Item Name Definition 1 ECG VS waveform Is the ECG waveform (Trace A, when enabled) Note To change the waveform speed, see Sweep Speed on page 3-25. 2 3 4 5 6 7 8 9 10 11 Alarm flag area Displays ECG alarm flags when detected; see page 4-31. ECG VS box label Indicates the ECG vital sign parameter, and accesses the ECG menu Unit of measure Indicates that the heart rate numeric is given in BPM (beats per minute) Heart rate numeric Is the patients detected heart rate measurement Magnet indication Indicates Magnet Filter when engaged. HR upper alarm limit HR lower alarm limit Is the upper limit setting for the heart rate alarm, and accesses the HR Alarm Limits menu Is the lower limit setting for the heart rate alarm, and accesses the HR Alarm Limits menu HR source Indicates the source used to measure the heart rate Filter mode Indicates the active ECG filter mode; see page 5-31. Electrode fault indication Displays the electrode fault indicator(s) when a disconnected ECG lead or bad electrode is detected, where LL = left leg, LA = left arm, and RA = right arm; and, LL, LA, RA, = RL right leg or all leads ExpressionMR400InstructionsforUseMonitoringECG523 Item Name Definition 12 ECG VS waveform Is the ECG waveform (Trace B, when enabled) Note To change the waveform speed, see Sweep Speed on page 3-25. 13 14 15 16 Scale indicator Represents a 1 millivolt signal amplitude for the selected scale of Trace B*

Lead type Lead type Is the selected ECG lead for Trace B Is the selected ECG lead for Trace A Scale indicator Represents a 1 millivolt signal amplitude for the selected scale of Trace A*

* The displayed waveform should at least be equal to the size of this indicator, as signals with lower amplitudes may be prone to gradient interference; see Checking the ECG Signal Strength on page 5-16 for details. Changing the Heart Rate Alarm Limits TheHeartRateAlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheECG VSbox. 8 9 10 11 12 13 14 15 16 1 67 5 34 2 Alarm limit settings, ECG VS box Extreme Tachycardia button 1 2 3 High button Low button 4 Extreme Bradycardia button 5 6 HR Alarm Limits menu label 524MonitoringECGExpressionMR400InstructionsforUse 7 8 9 10 11 12 13 14 15 16 Enter button Current adjustment Extreme Bradycardia delta value Extreme Bradycardia alarm setting Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum Extreme Tachycardia alarm setting Extreme Tachycardia delta setting Tochangetheheartratealarmlimitsettings Step 1 Action SelectthealarmlimitsettingsintheECGVSbox. 2 3 4 5 TheHRAlarmLimitsmenuappears.Currentsettingsaredisplayed. SelecttheLow,High,ExtrBrady,orExtrTachybutton. Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. Thecurrentadjustmentwillreflectthesetting. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangeotheralarmlimitsettings,repeatsteps2,3,and4. Thecurrentadjustmentwillreflectthechange. Note See chapter 4 for detailed alarm limit setting instructions and options. ExpressionMR400InstructionsforUseMonitoringECG525 ECG Menu ECGmenuitemsallowyoutocontrolECGtraces,functionsandsettings. ToopentheECGmenu SelecttheECGVSbox. ECG menu ECG VS box ThefollowingECGmenuitemsareavailable:. 1 2 3 4 5 6 7 8 9 10 Trace A Lead Trace B Lead Scale Gating Source HR Source HR Tone Source Filter Mode Extreme HR Pediatric ECG T-Wave Suppression 1 2 3 4 5 6 7 8 9 10 526MonitoringECGExpressionMR400InstructionsforUse TochangesettingsintheECGmenu Step 1 Action SelecttheECGVSbox. TheECGmenuappears.Currentsettingsaredisplayed. SelectfromthefollowingECGmenuitems:

2 TraceALead TraceBLead Scale GatingSource HRSource HRToneSource FilterMode ExtremeHR PediatricECG TWaveSuppression 3 Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptExtreme HR,PediatricECGandTWaveSuppression,whichareselectable ontheECGmenu). Thesettingisentered. 4 Tochangeothersettings,repeatsteps2and3. Trace A Lead SetstheECG A leadconfiguration(leadview).ForbestECGandheartratemonitoring,always selecttheoptimalleadview,theonethatprovidestheleastartifactandlargestwaveform detection. Thefollowingoptionsareavailable:

Off I II(Default) III AVL AVR AVF TosettheECGAlead ExpressionMR400InstructionsforUseMonitoringECG527 SeeChangingtheLeadViewonpage517. Trace B Lead SetstheECG B leadconfiguration(leadview),allowingyoutoviewtwoECGwaveforms simultaneously. Thefollowingoptionsareavailable:

Off(Default) I II III AVL AVR AVF TosettheECGBlead SeeChangingtheLeadViewonpage517. Scale SetsthescalefortheECG waveforms.Aftermakingthissetting,takenoteofthescaleindicator

(seepage522).Iftheselectedscaleresultsinawaveformwithdistortedorclippedpeaks, Overscalewillbedisplayedandanothersettingshouldbeselecteduntilthemessagestops. Thefollowingoptionsareavailable:

AutomakesthewaveformfilltheECGtracearea(notrecommendedforuseintheMR). 1x 5x 10x(Default) 15x 20x 25x 30x 40x TosettheECGscale SeeSelectingtheScaleonpage516. 528MonitoringECGExpressionMR400InstructionsforUse Note Scale does not affect the signal analyzed by the MR400 for QRS detection and ECG gating. Gating Source SetsthecardiacgatingsourcebasedonameasuredsignalthatisusedforMRsystemtriggering.

(ThisisthesameoptionasintheSPO2menu.) Thefollowingoptionsareavailable:

ECGoutputsasignalthatrepresentsthedetectionoftheRpeakofaQRScomplex.

(Default) Pulseoutputsasignalthatrepresentsthedetectionofthepeakoftheperipheralpulse complex. Tosetthegatingsource SeeAppendixDfordetails. 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 5-28. HR Source Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes

(identicaltoandinteractivewithsameoptionintheSPO2,P1andP2menus). Thefollowingoptionsareavailable:

Autosetsthesourceautomaticallyaccordingtothehighestpriorityactiveinputthatisfirst toreportvalidpatientdata.Thepriorityranking(highesttolowest)isECG,P1,P2,SPO2

(providedthattheP1andP2channelshavebeenlabeledABP;seeSetLabelonpage824 fordetails).Thesourcewillbecomeunavailablewhenithasproducednovaliddatafora periodoften(10)ormoreseconds.Thesystemexaminesthehighestpriorityactiveinput. Ifnotfound,thesecondhighestpriorityinputischosen,etcetera.Ifnonearepresent, thenNoneisdisplayedastheheartratemeasurementnumeric. ECGsetsECGasthesource.(Default) ABPsetsABPasthesource(ifnopressurechannelislabeledABP,awarningboxwillallow automaticrenamingandselectionbeforeproceeding;alsoseeSetLabelonpage824). ExpressionMR400InstructionsforUseMonitoringECG529 SPO2setsSPO2asthesource. Tosettheheartratesource Step 1 Action SelecttheECGVSbox. TheECGmenuappears.Currentsettingsaredisplayed. SelectHRSource. TheHRSourcemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfortheheartratesource:

2 3 Auto ECG ABP SPO2 Thesourceischanged. HR Tone Source Setsthesourceusedfortheheartratetone(identicaltoandinteractivewiththesameoptionin theMonitorSetup>SoundAdjustmenuandintheSPO2menu). Thefollowingoptionsareavailable:

Offremovestheheartbeatdetectedsymbolfromthedisplayandsoundsnopulsetone.

(Default) QRSprovidestheheartbeatdetectedsymbolandatonetriggeredbytheQRSdetection fromtheECGvitalsign. SPO2providestheheartbeatdetectedsymbolandatonemodulatedbytheSPO2vital sign,wherethelowertheSPO2value,thelowerthepitch. Tocontroltheheartratetonesource Step 1 Action SelecttheECGVSbox. TheECGmenuappears.Currentsettingsaredisplayed. 530MonitoringECGExpressionMR400InstructionsforUse Step 2 Action SelectHRToneSource. TheHRToneSourcemenuappears.Thecurrentsettingis highlighted. Selectthedesiredsettingforthetonesource:

3 Off QRS SPO2 Thesettingischanged. Filter Mode SetsthefilteringmodefortheECGsignal.AllfilteringmodeexceptMonitorutilizeanadaptive filterschemeforremovalofgradientartifactsgeneratedbyMRsystems. Notes Due to the variety of MRI sequence characteristics, if the filter recommendations below do not provide optimum performance in all cases, the selection may improve ECG performance during a specific scan sequence. 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 view (I, II, III, AVL, AVR, or AVF) that provides the best performance; see page 5-17. For cases not requiring cardiac gating, start with the Default filter (depending on the MRI sequence) then switch filters if a gradient artifact is noticed. If a gradient artifact is still present, check ECG signal strength and try lead I or III. Thefollowingoptionsareavailable:

Monitorisamodethatprovidesfilteringcharacteristicsthatmeetthespecificationofthe AAMIandIEC.Thismodeisusefulduringpatientpreparation,transporting,baselining,et cetera,butisnotmeantforuseduringactiveMRIsequencesduetonoise;seepage518. Defaultprovidesthebestpossibleperformanceon0.15to3.0TMRsystemsduringEcho TraintypeMRIsequences.(Default) Advanced1providesthebestpossibleperformanceduringcardiovascular(CV)MRIscans thatinvolvesteadystatefreeprecessionimagingwithbalancedgradient(TrueFISP, FIESTA,orBalancedFFE)sequenceson1.5and3.0TMRsystems.Forcasesrequiring cardiacgating,startwiththeCardiacfilterinLeadIIandswitchfiltersifagradientartifact isnoticed.Ifgradientartifactisstillpresent,checksignalamplitudeandtryLeadIorIII. ExpressionMR400InstructionsforUseMonitoringECG531 Advanced2providesthebestpossibleperformanceon1.5and3.0TMRsystemsfor removalofgradientartifactsgeneratedbyMRsystemsduringMRIsequencessuchas neurologicalandcardiovascularscans. Tosetthefiltermode SeeSelectingtheFilterModeonpage522. Extreme HR ControlsthealarmfunctionforExtremeBradycardia(whereadecreaseinheartratebya selectablevaluelowerthanthelowHRlimitsettingwillresultinanalarm),andforExtreme Tachycardia(whereanincreaseinheartratebyaselectablevaluehigherthanthehighHRlimit settingwillresultinanassociatedalarm). Thefollowingoptionsareavailable:

OffdoesnotreportanextremeHRalarmevent. OnreportsanextremeHRalarmeventwhendetectedanddisplaystheExtrBradybutton

(forExtremeBradycardia)andtheExtrTachybutton(forExtremeTachycardia)onthe ECGAlarmLimitsmenuandthecontrolsfortheextremeHRalarmadjustments.(Default) TocontroltheExtremeHRalarmfunction Step 1 Action SelecttheECGVSbox. TheECGmenuappears.Currentsettingsaredisplayed. LocateExtremeHRandselectthedesiredsetting:

2 Off On Thesettingisentered. Pediatric ECG ProvidesadditionalECGfilteringwhenpatients,particularlypediatrics,presentwithnarrowQRS complexesand/orhigh(120BPM)heartrates. Thefollowingoptionsareavailable:

OffdoesnotapplythepediatricECGfilter.(Default) OnprocessesECGdatausingapediatricalgorithm,inadditiontothegradientfiltersetting

(andwheniftheECGtraceisprinted,PEDECG=ONorPEDECG=OFFwillappearonthe strip). 532MonitoringECGExpressionMR400InstructionsforUse Note If Patient Type is set to Neo then Pediatric ECG is set to On and locked. When 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 TocontrolpediatricECGfiltering Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. LocatePediatricECGandselectthedesiredsetting:

2 Off On Thesettingisentered. T-Wave Suppression AllowsyoutoreducetheTwaveamplitudewhenextremelylargeduetothe magnetohydrodynamiceffect(MHD),whichcanpreventgating.Useforaccurategatingwhenan unusuallyhighTwaveamplitude,relativetotheRwaveamplitude,isproduced. Thefollowingoptionsareavailable:

Off(Default) On Note T-Wave Suppression is unavailable when Filter Mode is set to Monitor; see page 5-31. ExpressionMR400InstructionsforUseMonitoringECG533 TocontrolTwavesuppression Step 1 Action SelecttheECGVSbox. TheECGmenuappears.Currentsettingsaredisplayed. LocateTWaveSuppressionandselectthedesiredsetting:

2 Off On Thesettingisentered. 534MonitoringECGExpressionMR400InstructionsforUse CHAPTER 6 Monitoring SPO2 ThepulseoximetryfeatureoftheMR400usesamotiontolerantsignalprocessingalgorithm basedonFourierArtifactSuppressionTechnology(FAST)andiscalibratedtodisplayoxygenated hemoglobinmeasurements,avisualpulseindicationandapulserate,specifically:

Oxygensaturationofarterialblood(SPO2):Thepercentageofoxygenatedhemoglobinin relationtothesumofoxyhemoglobinanddeoxyhemoglobin(functionalarterialoxygen saturation). Plethysmography(pleth)waveform:Avisualindicationofthepatientspulsatileblood flow. Pulserate(asderivedfromtheplethwaveform):Thenumberofdetectedpulsationsper minute. PerfusionindexvalueAnumericalindicationofthepulsatileportionofthemeasured signalcausedbyarterialpulsation. CAUTION Before use, verify that the wSpO2 module is operating correctly and communicating by checking the displayed SPO2 numeric and waveform. Also, ensure that the wSpO2 module has a sufficiently charged battery by checking its displayed status symbol; see page 2-16. 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, SpO2 Probe and SpO2 Attachment ThewSpO2module,SpO2probeandSpO2attachment(cliporgrip)areintendedforpatientuses whennoninvasivearterialoxygensaturation,pulseratemonitoringorpulsegatingarerequired. ThewSpO2module,SpO2probeandSpO2attachmentmaynotbeusedwithintheMRsystem bore. ExpressionMR400InstructionsforUseMonitoringSPO261 WARNING Philips has verified the compatibility of the monitor, probe, and cable specified in the Accessory List. The user should verify that only Philips accessories specified in the Accessory List are used. Otherwise, patient injury can result. CAUTION If dropped, the wSpO2 module must be verified for correct operation before use; see page 14-12. Note Refer to your facility's biohazard procedure for disposal of SPO2 attachments and probes when they become unusable. Usually probes are disposed of as medical waste per facility procedures. Patient Preparation for SpO2 Monitoring WhenmonitoringSpO2,theSpO2attachment,thesiteselectedonthepatient,theSpO2 attachmentspositiononthepatient,andtheambientenvironmentwillimpacttheperformance andoperationoftheparameter. Selecting the Site and SpO2 Attachment Whenapplyingtheclipsorgripstothepatient,sitepreparationandthepressureandalignment oftheSpO2attachmentareimportantfactorstoconsider.Selectthemostappropriatelimbthat bestfitstheattachmentssize.Formeasurementstobeaccurateandreliable,theoptimumfitis reachedwhenthefiberheadwindowsontheattachmentopposeeachotherwhilecoveringskin ornail.RefertotheinstructionsprovidedwiththeSpO2attachmentwhenselectingand connectingthecliporgrip. 62MonitoringSPO2ExpressionMR400InstructionsforUse Attaching the Clip or Grip to the SpO2 Probe Toattachaclip(orgrip)totheSpO2probe CarefullysnapthefiberheadsontheSpO2probeintothe receptacles(windows)ontheSpO2attachment(cliporgrip). Eitherfiberheadcanbeinsertedintoeitherwindowonaclipor grip. 2 3 1 2 3 SpO2 probe SpO2 attachment (clip shown) Fiber heads 1 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 probe from contact with any liquid. If the probe, 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. ExpressionMR400InstructionsforUseMonitoringSPO263 ToapplyareusableSpO2cliptothepatient Step 1 Action Selecttheapplicationsite.ItshouldmatchtheSpO2clipsizeso thattheattachmentdoesnotfallofforapplyexcessivepressureat thesite. 2 3 4 5 Ifpresent,removeanycolorednailpolishfromtheapplicationsite. Pressthecliptoopen. Pushtheclipoverafingersoeither fiberheadisonthetopovertheroot ofthenailandtheotherfiberhead oppositetoit. Ensurethatthefingeristouchingthestopatthecushionandlays nicelycenteredintheclip. ToapplyadisposableSpO2grip(all,exceptneonate)tothepatient Step 1 Action Selecttheapplicationsite.ItshouldmatchtheSpO2gripsizeso thattheattachmentdoesnotfallofforapplyexcessivepressureat thesite. 2 3 4 5 6 Ifpresent,removeanycolorednailpolishfromtheapplicationsite. Liftoffthereleaselinersthatprotecttheadhesive. Putthefinger(ortoe)ontoeithersideoftheattachmenttheyare symmetricalsuchthatthetipcoversthewindowcompletelyand doesnotprotrudeoverthehinge. Closethegrip.Ifthefitisgood,presstheattachmentfirmlyonthe fingerortoe.Ifthefitisnotgood,repositiontheattachment.Make surethelimbiscenterednicelyintheattachment. Wrapthefoamwingsaroundthefin gerandattachmentandsticktothe opposinggripside.Donotstretchthe foamtoapplyexcessivepressure. 64MonitoringSPO2ExpressionMR400InstructionsforUse ToapplyadisposableneonateSpO2griptothepatient Step 1 Action Selecttheapplicationsite.ItshouldmatchtheSpO2gripsizeso thattheattachmentdoesnotfallofforapplyexcessivepressureat thesite. 2 3 4 5 6 7 Liftoffthereleaselinersthatprotecttheadhesive. Proceedaccordingtotheapplicationsite:

Footapplication:Alignthehingeontheoutsidefacingridge ofthefoot.Makesuretheattachmentisasfaraspossibleto wardthesmalltoebutnotoverit. Hand/Wristapplication:Alignthehingeontheoutsidefac ingridgeofthehandorwrist.Youmayhavetoswivelthefi berheadstoanoptimalpositiontoeasetheapplication. Withthehingealignedwiththeridgeofthefoot/hand/wrist,press onesidetotheskinandthenwraptheothersidearoundthelimb pullingthelongfoampiecegently. Pressbothfiberheadsgentlytoattach theadhesives. Securethelongerfoampiecebypressingitfirmlytothefoam/

adhesiveoftheopposingside. Ensurethatthetwofiberheadsareopposingandhavegoodskin contact.Theanglebetweenthetwofiberheadsshouldbeassmall aspossible,notexceeding45.Iftheattachmentopenstoomuch, reattachortryanothersite. WARNING Disposable SpO2 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. ExpressionMR400InstructionsforUseMonitoringSPO265 Perfusion Index Value Whenenabled,thedisplayedperfusionindexvalue(seepage68)isanindicationofthepulsatile portionoftheSpO2signalcausedbythepatient'sarterialbloodflow.Ifyouneedanindicationof changeinpulsevolume,useperfusionindexvalue.Thisvaluecanalsobeusedasaquality indicatoroftheSpO2measurementfromthemodule.Thetablebelowprovidesgeneralguidelines regardingthisindexvalue. PerfusionIndexValue Meaning Above1.0 0.3to1.0 Below0.3 Optimalhighqualityreadings Acceptablegoodqualityreadings MarginalAttachmentpositionshouldbeadjusted oranothersiteshouldbeused. Note If a Low Perf alarm is generated, see page 4-32 for corrective actions. Positioning the wSpO2 Module for Scanning WARNING The wSpO2 module must be kept outside the MR system bore or image distortion may result. Toensurethebestperformance,specificpositioning considerationsarerequiredwhenusingthewSpO2modulein theMRmagnetroom,includingduringharshscansequences withperipheralnervestimulationlevelsabove80percent. Whileconsideringthescantobeperformed:

PlacethewSpO2moduleonornearthepatientandas closeaspossibletotheboreopening;

KeeptheSpO2probeandwSpO2moduleoutsidetheMR systembore;

PlacethewSpO2moduleonacushionedsurfaceto minimizeMRvibrations;and, CovertheSpO2attachmentsiteonthepatientwith opaquematerial. 66MonitoringSPO2ExpressionMR400InstructionsforUse 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 3 4 5 6 7 Action Ensurethatthefiberheadsaredirectlyoppositeeachother,asthe lightmustpassthroughthepatientstissueandbereceivedfor properoperation. Swiveleachfiberheadintoapositionthatcausestheleastbending ofthecablewhileprovidingthemostcomforttothepatient. CheckthebatteryindicatoronthewSpO2moduletoensurethat enoughchargeexists:

Greenbatteryindicator=Chargesufficient;proceedtostep5. Redbatteryindicator=Chargelow;proceedtostep4. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) InsertachargedmodulebatteryintothewSpO2moduleandthen recheckthebatteryindicatortoensureasufficientchargebefore proceeding;seepage126. CheckthenetworkchannelindicatoronthewSpO2moduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep7. Flashing=Nocommunication;proceedtostep6. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) EnsurethatthewSpO2moduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129. ChecktheperfusionindexvalueforthequalityoftheSpO2 measurementfromthemodule;seepage66fordetails. ExpressionMR400InstructionsforUseMonitoringSPO267 Step 8 Action SelectthePatientType. 9 10 11 12 13 14 SeeSelectingthePatientTypeonpage311. CheckforanydisplayedSPO2messages Ifamessageispresent,followtherecommendedactiontoachieve betterresults(seepage426). Placethemoduleascloseaspossibletotheboreopening.(Ifthe modulecanbeplacedoutsidethebore,positioningattheiso centerisnotnecessary.) KeeptheSpO2probeandmoduleoutsidetheMRsystembore. Placethemoduleonacushionedsurface. CoverthepatientSpO2attachmentsitewithopaquematerial. Duringmeasurement,checkthepatienttoensurethatthe applicationsitehasapulsatileflowandthatthesitehasnot changedinthickness(forexample,duetoedema)causingan improperfit. SPO2 Waveform and VS Box TheSpO2measurementsaredisplayedasawaveformintheVStraceareaofthescreenandas numericinformationintheSPO2VSbox.Otherdata,includingSpO2relatedalarminformation, arealsoprovidedinthisareaofthescreen,asdetailedbelow. 1 2 3 4 5 9 6 8 7 68MonitoringSPO2ExpressionMR400InstructionsforUse Item Name Definition 1 SpO2 VS waveform Is the detected SpO2 (pleth) pulsatile waveform (Trace C), automatically adjusted for proper viewing if above a minimum level Note To change the waveform speed, see Sweep Speed on page 3-25. 2 3 4 5 6 7 8 9 Alarm flag area Displays SPO2 alarm flags when detected; see page 4-31. SPO2 VS box label Indicates the SpO2 vital sign parameter, and accesses the SPO2 menu Heart rate numeric Is the patients detected heart rate measurement Unit of measure Indicates that the heart rate numeric is given in BPM (beats per minute) SpO2 upper alarm limit SpO2 lower alarm limit Is the upper limit setting for the SpO2 alarm, and accesses the SPO2 Alarm Limits menu Is the lower limit setting for the SpO2 alarm, and accesses the SPO2 Alarm Limits menu SpO2 numeric Perfusion index Is the patients detected arterial oxygen saturation measurement, given as a percentage Is the value for the portion of the measured signal caused by the pulsating arterial blood flow, which can be used as a measurement quality indicator; see page 6-15 Assessing Suspicious SPO2 Readings Pulseoximetrymeasurementsarestatisticallydistributed.Withneweralgorithms,suchasFAST SPO2,thecalculationofSPO2isnotdirectlylinkedtothecorrectdetectionofeachpulse.When thepulserateisveryloworastrongarrhythmiaispresent,theSPO2/plethysmographypulse ratemaydifferfromtheheartratecalculatedfromECG.Thisdoesnotindicateaninaccurate SPO2value.IfyoudoubtthemeasuredSPO2,usetheplethysmographywavetoassessthesignal quality. WARNING 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. ExpressionMR400InstructionsforUseMonitoringSPO269 WARNINGS 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 probe is not attached to a patient. Bandage and grip attachment designs are particularly sensitive to minimal movement that might occur when the probe is dangling, not attached to the patient. An unapplied probe may cause readings to be displayed on the monitor. To avoid misdiagnosis, ensure the probe is applied to patient correctly. Changing the SPO2 Waveform Amplitude TheverticalscaleofthedisplayedSPO2waveformcanbechangedtobestsuittheviewing requirements. TochangetheSPO2waveformamplitude Step 1 Action SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed. SelectSize. TheSizemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsize:

2 3 10%

20%

40%

60%

80%

100%

Thesettingischanged. 610MonitoringSPO2ExpressionMR400InstructionsforUse Changing the SPO2 Alarm Limits TheSPO2AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheSPO2VS box. 7 98 10 11 12 1 56 4 3 2 Alarm limit settings, SPO2 VS box 1 2 High button Low button 3 4 Desat button 5 6 7 8 9 10 11 12 SPO2 Alarm Limits menu label Enter button Current adjustment Desat alarm setting Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum TochangetheSPO2alarmlimitsettings Step 1 Action SelectthealarmlimitsettingsintheSPO2VSbox. TheSPO2AlarmLimitsmenuappears.Currentsettingsare displayed. SelecttheLow,High,orDesatbutton. 2 Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed.(Desatmustbeon;seepage615.) ExpressionMR400InstructionsforUseMonitoringSPO2611 Step 3 Action Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. 4 5 Thecurrentadjustmentwillreflectthesetting. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangeotherlimitsettings,repeatsteps2,3,and4. Thecurrentadjustmentwillreflectthechange. Note See chapter 4 for detailed alarm limit setting instructions and options. SPO2 Menu SPO2menuitemsallowyoutocontrolSPO2functionsandsettings. ToopentheSPO2menu SelecttheSPO2VSbox. SPO2 menu SPO2 VS box 612MonitoringSPO2ExpressionMR400InstructionsforUse ThefollowingSPO2menuitemsareavailable:

1 2 3 4 5 6 7 8 Size Averaging Time Perfusion Index Gating Source Desat Desat Time HR Source HR Tone Source 1 2 3 4 5 6 7 8 TochangesettingsintheSPO2menu Step 1 Action SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed. TouchthemenuitemtoselectoneofthefollowingSPO2options:

Size AveragingTime PerfusionIndex GatingSource Desat DesatTime HRSource HRToneSource Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptPerfusion IndexandDesat,whichareselectableontheSPO2menu). Thesettingisentered. Tochangeothersettings,repeatsteps2and3. 2 3 4 Size ChangestheverticalscaleoftheSPO2(pleth)waveformsothathighamplitudescanbescaled downtoavoidclippingofthepeaksandlowamplitudescanbescaleduptoviewthepeaks. Thefollowingoptionsareavailable:

ExpressionMR400InstructionsforUseMonitoringSPO2613 10%

20%

40%

60%

80%

100%(Default) ToadjustthesizeoftheSPO2waveform SeeChangingtheSPO2WaveformAmplitudeonpage610. Averaging Time Selectshowquicklythereadingrespondstochangesinthepatientssaturation,whereselecting alongerdurationwillpreventthesaturationvaluefromchangingquicklywhichcanbeusefulfor avoidingalarmtriggeringinpatientswithverydynamicconditionssuchasneonataland pediatrics. Thefollowingoptions(inseconds)areavailable:

5Sec 10Sec(Default) 15Sec TosettheaveragingtimeoftheSPO2reading Step 1 Action SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed. SelectAveragingTime. TheAveragingTimemenuappears.Thecurrentsettingis highlighted. Selectthedesiredtimeforaveraging:

2 3 5Sec 10Sec 15Sec Thesettingischanged. 614MonitoringSPO2ExpressionMR400InstructionsforUse Perfusion Index Controlstheperfusionindexvalueindicationandalarmfunction(seepage56).Thefollowing optionsareavailable:

Offdisablestheperfusionindexfunctions. Onenablestheperfusionindexfunctions.(Default) Tocontroltheperfusionindexfunctions Step 1 Action SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed. LocatePerfusionIndexandselectthedesiredsetting:

2 Off On Thesettingisentered. Gating Source SetsthecardiacgatingsourcebasedonameasuredsignalthatisusedforMRsystemtriggering.

(ThisisthesameoptionasintheECGmenu.) Thefollowingoptionsareavailable:

ECGoutputsasignalthatrepresentsthedetectionoftheRpeakofaQRScomplex.

(Default) Pulseoutputsasignalthatrepresentsthedetectionofthepeakoftheperipheralpulse complex. Tosetthegatingsource SeeAppendixDfordetails. Desat ControlsthedesaturationalarmandallowsadjustmentoftheDesatalarmsetting(seepage6 11),whereaDesatalarmwillbedeclaredwhenthedetectedoxygenationconditionhas remainedatorbelowthevaluefortheperiodestablishedbytheDesatTimesetting(seepage6 16). Thefollowingoptionsareavailable:

Offdisablesthedesatalarmfunction. ExpressionMR400InstructionsforUseMonitoringSPO2615 Onenablesthedesatalarmfunction.(Default) Tocontrolthedesatalarmfunction Step 1 Action SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed. LocateDesatandselectthedesiredsetting:

2 Off On Thesettingisentered. Desat Time WhenDesatison,thissetsthetimethatmustpassbeforedeclaringthatadesaturation conditionexists. Thefollowingoptions(inseconds)areavailable:

20Sec(Default) 25Sec 30Sec 35Sec 40Sec Tosetthedesattime Step 1 Action EnsurethatDesatisOn.SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed.(Seepage 615fordetails.) 616MonitoringSPO2ExpressionMR400InstructionsforUse Step 2 Action SelectDesatTime. TheDesatTimemenuappears.Thecurrentsettingishighlighted. Selectthedesiredtime(inseconds)forthealarmindication:

3 20Sec 25Sec 30Sec 35Sec 40Sec Thesettingischanged. HR Source Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes

(identicaltoandinteractivewithsameoptionintheECG,P1andP2menus). Thefollowingoptionsareavailable:

Autosetsthesourceautomaticallyaccordingtothehighestpriorityactiveinputthatisfirst toreportvalidpatientdata.Thepriorityranking(highesttolowest)isECG,P1,P2,SPO2

(providedthattheP1andP2channelshavebeenlabeledABP;seeSetLabelonpage824 fordetails).Thesourcewillbecomeunavailablewhenithasproducednovaliddatafora periodoften(10)ormoreseconds.Thesystemexaminesthehighestpriorityactiveinput. Ifnotfound,thesecondhighestpriorityinputischosen,etcetera.Ifnonearepresent, thenNoneisdisplayedastheheartratemeasurementnumeric. ECGsetsECGasthesource.(Default) ABPsetsABPasthesource(ifnopressurechannelislabeledABP,awarningboxwillallow automaticrenamingandselectionbeforeproceeding;alsoseeSetLabelonpage824). SPO2setsSPO2asthesource. Tosettheheartratesource Step 1 Action SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed. SelectHRSource. 2 TheHRSourcemenuappears.Thecurrentsettingishighlighted. ExpressionMR400InstructionsforUseMonitoringSPO2617 Step 3 Action Selectthedesiredsettingfortheheartratesource:

Auto ECG ABP SPO2 Thesourceischanged. HR Tone Source Setsthesourceusedfortheheartratetone(identicaltoandinteractivewithsameoptioninthe intheMonitorSetup>SoundAdjustmenuandintheECGmenu). Thefollowingoptionsareavailable:

Offremovestheheartbeatdetectedsymbolfromthedisplayandnopulsetonewillbe sounded.(Default) QRSprovidestheheartbeatdetectedsymbolandatonetriggeredbytheQRSdetection fromtheECGvitalsign. SPO2providestheheartbeatdetectedsymbolandatonemodulatedbytheSPO2vital sign,wherethelowertheSPO2value,thelowerthepitch. Tocontroltheheartratetonesource Step 1 Action SelecttheSPO2VSbox. TheSPO2menuappears.Currentsettingsaredisplayed. SelectHRToneSource. TheHRToneSourcemenuappears.Thecurrentsettingis highlighted. Selectthedesiredsettingforthetonesource:

2 3 Off QRS SPO2 Thesettingischanged. 618MonitoringSPO2ExpressionMR400InstructionsforUse Monitoring CO2 (LoFlo Option) CHAPTER 7 WhenequippedwiththeLoFloCO2option,thepatientsairwayrespiratorygascanbe monitored.Thesystemusessidestreammeasurementstoproduce:

AfractionalinspiredCO2(FiCO2)value(thelowestreadingoftheCO2waveforminthe previous20seconds)andanendtidalCO2(EtCO2)valuemeasuredduringexpiration. Arespirationrate:Thenumberofbreathsperminute. Awaveformoftheconcentrationofcarbondioxideintherespiratorygases. 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 MR400 is too close to the MR magnet and shutdown of CO2 monitoring will occur. Always position the MR400 as indicated on page 3-2. Note LoFlo option-equipped models do not feature a water trap (see page 7-4). If your MR400 is equipped with a water trap, refer to chapter 9 for CO2 monitoring instructions. MR400 Preparation for CO2 Monitoring WhenpreparingtheMR400forCO2monitoring,ensurethatthewastegasport(seepage119) hasbeenconnectedtoyourfacilitysgasscavengingsystemfordisposalofsampledand calibrationgases. Note Never route the waste gas tubing in a location that will allow it to be an obstruction or stepped on. ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)71 Operation and Use Whenmonitoringanestheticagentgases,thetypicaloperationsandpossibleconditionsthatcan arisemayresultinpotentialmessagesrequiringyourattention.Seepage426foramessage listingandsuggestedactions. Warm-Up Period Inordertoachieveaccurateidentificationsandmeasurements,theLoFlosystemrequiresa warmupperiodtothermallystabilize.ThiswarmupperiodbeginswhentheCO2parameteris activated.Uponactivation,CO2WarmingUpwillbedisplayeduntiltheLoFlosystembecomes fullyoperational(about2minutes). Zero Reference Adjustment WARNING During Zero calibration the system pulls ambient air through the zero intake port on the cart The calibration system assumes that the ambient air will contain normal trace amounts of CO2. If the system is placed in an unventilated area that allows CO2 (from the waste gas port on the rear panel, if not connected to a gas scavenging system) to accumulate, the result could be inaccurate CO2 zeroing and resulting inaccurate patient readings. Always place the cart in a well ventilated area. TheLoFlosystemwilloccasionallyperformazeroreferenceadjustment(ZeroCal)toensurethe accuracyofthedisplayedgasconcentrations.PerformingCO2Zerowillbedisplayedduringazero referenceadjustment;allowtheprocesstocomplete.Themaximumtimerequiredforcalibrationis approximately40seconds.ZeroCalisnotrequiredwhenswitchingsamplinglines. Undercertainconditions,ZeroCalwillnotbeallowed:

Iflessthan20secondshavepassedsincedetectionofthelastbreath;

IftheCO2temperatureisunstable;or IfthesamplinglineisdisconnectedfromtheCO2port. Toperformamanualzeroreferenceadjustment Step 1 Action IfCO2WarmingUpisdisplayed,waitasthesystemthermally stabilizes.Whenthemessageiscleared,proceed. 72MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse Step 2 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. SelectZeroCal. 3 CalibrationwillbeginandPerformingCO2Zerowillbedisplayed. Whencomplete,themessagewillberemoved. Breath Rate Distortion Theeffectofrisetimedistortiontothegascurvebecomesapparentwhenthebreathingrate increasessothatthetimeforafullinspiratoryorexpiratoryeventgetsshorter.Inthose situations,duetotheeffectoftherisetime,thegascurvedoesnotreachthetrueendtidal(or firstinspiredvalue)andtheendtidalgasvaluemaythenbeunderestimated.Correspondingly, thefirstinspiredvaluemaybeoverestimated.Belowisanexaggeratedillustrationoftheeffect. Percent

- - at gas sampling site as presented by gas analyzer Et error Fi error Time Thebreathratelimitforaccuratelyresolvedendtidalgasvalues(atanI:Eratioof1:1)maybe foundinAppendixA.TheeffectofotherI:Eratiosmaybecalculatedbydeterminingthelengthof theshortestinspiratory/expiratoryeventthatcanberesolvedaccurately:

tresolved=60/(2xBRlimit(1:1) BRlimit(I:E)=60/((I+E)xtresolved) Thedifferenceintheseresultswhencomparedtotherisetime'sspecificationisthatrisetime's onlytests1090%performance.Thisspecificationisfor(0+accuracy)to(100accuracy)%andis thusmuchtougher.Theabilitytoproperlyresolveendtidalvaluescanbemeasuredbyusingthe setupdescribedinISO80601255:2011figure201.101.Inshort,themethodconsistsof samplinggasfromtwodifferentsourcesconnectedtoanelectricallycontrolledpneumaticvalve topermitrapidswitchingbetweenthetwosources.Duringthetest,thevalveissettoswitchgas sourceatanumberoffrequencies(simulatingtherangeofspecifiedbreathrates)andforeach frequencytheendtidalvaluepresentedbythegasanalyzerisnoted.Fromadiagramofendtidal valueoverfrequency,thefrequencyatwhichthegasanalyzerisnolongerabletoresolveend tidalvaluesaccordingtospecificationisidentified.Thisabilitytoproperlyresolveendtidalvalues islistedinthespecification. ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)73 Patient Preparation for CO2 Monitoring Whenpreparingapatient,theaccessorypositiononthepatientwillimpacttheperformanceand operationoftheCO2parameter. Selecting the CO2 Accessory Inpatientsonabreathingcircuit,asampleoftherespiratorygasisdrawnfromthepatients breathingcircuitthroughanairwayadapterandagassamplingline.Inpatientswhoarenotona breathingcircuit,thegassampleisdrawnthroughanasalcannula.Thesespeciallydesigned cannulasandonairwayadaptersincorporateafilterandsamplecelltoprovidemaximum filtrationoffluidsandcontaminantstoprotectagainstsystemintake.WhenselectingCO2 accessories(seepage134foralisting),considerthefollowing:

Thetypeofpatient(adult,pediatric,orneonatal) Whetherthepatientisreceivingsupplementaloxygen Theconditionofthepatient Allaccessoriesaresingleuse. Connecting the Sampling Line Toconnectthesamplingline Step 1 Action InsertthesamplinglineconnectorintotheCO2portonthepatient connectionpanelandthenpushtheconnectorforwarduntilyou feelorhearitclickintoplace. CO2 port Sampling line connector 74MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse 2 3 IfCO2WarmingUpisdisplayed,waitasthesystemthermally stabilizes(about2minutes).Whenthemessageiscleared, proceed. 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, we recommend turning the CO2 parameter off; see Parameters on page 3-18. 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. 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 the patient sampling line after attachment to the MR400. ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)75 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. Toapplythesamplinglinetothepatient Step 1 2 3 4 5 6 Action Ensurethatthesamplinglineisclean,dryandundamaged.Replace thelineifnecessary. InsertthesamplinglineconnectorintotheCO2port(seepage74). Aclickwillbeheardwhenproperlyinserted. Positionthecannulaonthepatientsfaceby insertingthenasalprongsintothenostrils. Passthetubingovertheearsandbehindthehead, ensuringthepatientsheadwillnotrestonanypart ofthecannulawhilethepatientislyingdown. Slidethesleevetowardthepatientsheadtoassurea goodfitofthecannula. Ifusingthesamplinglinewiththeairwayadapter,proceedtostep 7;otherwisegotostep8. 76MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse Step 7 Action Placetheairwayadapterattheproximalendoftheairwaycircuit. 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. 8 9 SelectthePatientType. SeeSelectingthePatientTypeonpage311. Checkthattheconnectionshavebeenmadecorrectlybyverifying thepatientsbreathingeffortswiththedisplayedwaveform. WARNING Before completion of patient setup, ensure that the patients breathing efforts coincide with the displayed CO2 waveform. 10 Ifthefollowingwarningisdisplayed:

PersistentCO2occlusiondetected. PleaseclearocclusionandpressOK toresumeusingCO2 Clearanypinchesorobstructionsinthesamplinglinebefore proceeding. CO2 Waveform and VS Box TheCO2measurementisdisplayedasawaveformintheVStraceareaofthescreenandas numericinformationintheCO2VSbox.Otherdata,includingCO2relatedalarminformation,are ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)77 alsoprovidedinthisareaofthescreen.(CO2[RESP]informationcanbedisplayedintheCO2VS boxorintheRESPVSbox,asdetailedbelow.) 1 2 3 4 5 6 7 8 9 10 12 11 Item Name Definition 1 CO2 VS waveform Is the detected CO2 waveform (Trace D) Note To change the waveform speed, see Resp Speed on page 3-25. 2 3 4 5 6 7 8 9 10 11 12 Alarm flag area Displays CO2 alarm flags when detected; see page 4-31. CO2 VS box label Unit of measure Indicates the CO2 vital sign parameter, and accesses the CO2 menu Indicates that the gas measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see page 7-11. FiCO2 numeric Is the patients detected fractional inspired CO2 measurement EtCO2 numeric Is the patients detected end-tidal CO2 measurement EtCO2 upper alarm limit EtCO2 lower alarm limit Respiration rate upper alarm limit Respiration rate lower alarm limit Is the upper limit setting for the end-tidal CO2 alarm, and accesses the CO2

(Et) Alarm Limits menu Is the lower limit setting for the end-tidal CO2 alarm, and accesses the CO2

(Et) Alarm Limits menu Is the upper limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu Is the lower limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu Respiration rate numeric Is the patients detected respiration rate measurement, as derived from CO2 Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) When Source is set to BEL in the RESP menu (see page 10-5), the CO2 VS box will also contain CO2-derived respiration rate elements, as indicated by the shaded rows and illustration above; otherwise, this information will be displayed in the RESP VS box

(see page 7-10). 78MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse Changing the CO2 and CO2 (RESP) Alarm Limits TheCO2(Et)andCO2(Fi)AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettings intheCO2VSbox. 7 8 9 10 11 1 456 3 2 Alarm limit settings, CO2 (Et), CO2 VS box 1 2 High button Low button 3 4 CO2 (Et) Alarm Limits menu label (active adjustment shown) 5 CO2 (Fi) Alarm Limits menu label 6 7 8 9 10 11 Enter button Current adjustment Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum TochangetheCO2(Et)andCO2(Fi)alarmlimitsettings Step 1 Action Selectthe(Et)CO2alarmlimitsettingsintheCO2VSbox. TheCO2AlarmLimitsmenuappears.CurrentCO2(Et)settingsare displayed. SelecttheCO2alarmlimitsmenu,CO2(Et)orCO2(Fi),thatyou wanttochange. 2 Theassociatedmenuappears.Currentsettingsaredisplayed. ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)79 Step 3 Action SelecttheLowbuttonortheHighbutton. Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. Thecurrentadjustmentwillreflectthesetting. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangetheremainingsettings,repeatsteps25. Thecurrentadjustmentwillreflectthechange. 4 5 6 Atthedefaultsetting,theCO2(RESP)AlarmLimitsmenucanbeaccessedbytouchingthealarm limitsettingsintheRESPVSbox. 6 7 8 9 10 1 2 3 5 4 1 High button Low button 2 Alarm limit settings, CO2 (RESP), RESP VS box 3 4 CO2 (RESP) Alarm Limits menu label 5 6 7 8 9 10 Enter button Current adjustment Lower alarm limit setting Alarm limit, minimum Upper alarm limit setting Alarm limit, maximum 710MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse TochangetheCO2(RESP)alarmlimitsettings Step 1 Action SelecttheCO2(RESP)alarmlimitsettingsintheRESPVSbox(or,in theCO2VSbox,seepage77.) TheCO2(RESP)AlarmLimitsmenuappears.Currentsettingsare displayed. SelecttheLowbuttonortheHighbutton. Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. Thecurrentadjustmentwillreflectthesetting. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangetheremainingsetting,repeatsteps2,3,and4. Thecurrentadjustmentwillreflectthechange. 2 3 4 5 Note See chapter 4 for detailed alarm limit setting instructions and options. Changing the Unit of Measure Tochangetheunitofmeasure Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)submenuappears. OntheService(BioMed)menu,selectSystemConfig. TheSystemConfigmenuappears.Currentsettingsaredisplayed. ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)711 Step 4 Action OntheSystemConfigmenu,selectGasUnits. TheGasUnitsmenuappears.Thecurrentsettingishighlighted. Selectthedesiredunitofmeasure:

5 mmHg kPa Thesettingischanged. CO2 Menu TheCO2menuallowsyoutocontroltheCO2andCO2(RESP)monitoringfunctionsandsettings. ToopentheCO2menu SelecttheCO2VSbox. CO2 menu CO2 VS box 712MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse ThefollowingCO2menuitemsareavailable:

1 2 3 Size Grids Zero Cal 1 2 3 Note Apnea and Apnea Time will be in the CO2 menu when bellows (BEL) is the selected RESP >

Source; see page 10-7 for setting details. TochangesettingsintheCO2menu Step 1 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. TouchthemenuitemtoselectoneofthefollowingCO2options:

Size Grids ZeroCal Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptGrids, whichisselectableontheCO2menu). Thesettingisentered. Tochangeothersettings,repeatsteps2and3. 2 3 4 Size ControlsthesizeoftheCO2waveform. Thefollowingoptionsareavailable:

40mmHg(Default) 60mmHg 80mmHg ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)713 ToadjustthesizeoftheCO2waveform Step 1 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. SelectSize. TheSizemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsize:

2 3 40mmHg 60mmHg 80mmHg Thesettingischanged. Grids Displaysascaledgrid,whichisgraduatedaccordingtotheSizeselectionfortheCO2waveform. Size Grid Thefollowingoptionsareavailable:

Offdoesnotdisplayagrid.(Default) Ondisplaysagrid. Note Grids will not be displayed during a CO2 Accuracy Check; see page 3-30. 714MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse TocontrolthedisplayfunctionfortheCO2grid Step 1 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. LocateGridsandselectthedesiredsetting:

2 Off On Thesettingisentered. Zero Cal Initiatesazerocalibration(anautomaticfunctionduringnormaluse)oftheCO2systemtoallow forthedifferentcharacteristicsofeachaccessorytype.ZeroCalisnotrequiredwhenswitching samplinglines. Undercertainconditions,ZeroCalwillnotbeallowed:

Iflessthan20secondshavepassedsincedetectionofthelastbreath;

IftheCO2temperatureisunstable;or IfthesamplinglineisdisconnectedfromtheCO2port. Toperformazerocalibration Seepage72. ExpressionMR400InstructionsforUse MonitoringCO2(LoFloOption)715 716MonitoringCO2(LoFloOption) ExpressionMR400InstructionsforUse Monitoring Invasive Blood Pressure CHAPTER 8 Whenequippedwiththeinvasivebloodpressureoption,theMR400providescompatibilitywith standardinvasivebloodpressuretransducershavinga5V/V/mmHgsensitivity,andofferstwo invasivebloodpressurechannels,P1andP2. Indications and Contraindications Adult and Pediatric Patients Indications Directarterialpressuremonitoring Leftatrialmonitoringwithanaireliminatingfilterbetweensolutionsourceandcontinuous flushdevice Pulmonaryarterymonitoring(PAdistal) Venouspressuremonitoring(RAproximal) Cardiaccatheterization Contraindications Leftatrialmonitoringwithoutanaireliminatingfilterbetweensolutionsourceand continuousflushdevice Intracranialpressuremonitoring Compartmentalpressuremonitoring Intrauterinepressuremonitoring Neonatal Patients WARNING Do not use a pressure administration cuff. Indications Umbilicalarterycatheterizationofneonates Invasivepressuremonitoringwithinfusionpump ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure81 Contraindications Leftatrialmonitoringwithoutanaireliminatingfilterbetweenthesolutionsourceand continuousflushdevice Intracranialpressuremonitoring Compartmentalpressuremonitoring Intrauterinepressuremonitoring Patient Preparation for IBP Monitoring Whenpositioningthepatient,routineIBPmeasurements(includingforthecondition hypertension)requirethepatienttoremainsilent,stillandrelaxed,withlegsuncrossedandarms supported.NotethatduringMRIprocedures,patientsaretypicallylayingdownwiththeirlegs uncrossedandarmssupportedasneededfortheMRIscan.Wealsorecommendwaiting5 minutesbeforetakingreadings. Transducer Component, Connection, and Feature Locations Theillustrationbelowdetailsthepressuretransducer(REF989803179721)component,feature, andconnectionlocations.Ifusingadifferentkit,refertothemanufacturersinstructionswhich accompanythatkit. 1 2 3 4 5 6 To patient Site line Zero reference stopcock Zero port Transducer Transducer cable 82MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse 7 8 9 10 11 Press here to disconnect transducer from reusable cable Reusable cable connector Transducer cable connector To fluid source Squeeze continuous flush device MR 400 Preparation for IBP Monitoring FollowtheprocedurebelowtopreparetheMR400forIBPmonitoringwhenusingtheExpression MRIBPDPTKits(Adult/Pediatric,REF989803194631;and,Infant/Neonatal,REF989803194641). Astherearepreparationdifferences,alwaysfollowtheappropriateprocedure. TopreparetheMR400forIBPmonitoringusingtransducerkitsotherthanthosereferenced below,orforcomponentsaddedtothemonitoringsystem,refertoapplicablemanufacturers instructionsforsetupanduse. WARNINGS Invasive blood pressure transducers are sensitive to vibrations that can occur during MRI scanning, which can lead to pressure reading inaccuracies. Always mount the invasive blood pressure transducer away from areas where vibration is likely to occur. The fluid within the pressure transducer system is a conductive connection to the patient, and must not contact other conductive parts, including earth ground. Do not allow fluids to enter the electrical connections of the transducer cables. Erratic readings may result. Always reference the manufacturers instructions and follow the safe use instructions included with the IBP transducer kit when monitoring invasive blood pressure. Never attach the pressure transducer(s) directly to the patient as excessive heating can occur resulting in burn injuries to the patient. If air bubbles appear in the tubing system, flush the system with the infusion solution again. Air bubbles may lead to a wrong pressure reading. Transducers do not protect against burns when used with high-frequency (HF) surgical equipment. A transducer cable or other cable that becomes inadvertently looped during an MRI examination may act as conductive lines for RF induced currents, resulting in excessive heating and possible burns. When transducer cables or other cables form a conductive loop in contact with the patient's tissue, minor to severe burning can result. Do not allow the transducer cable or other cable to touch the patient or to become looped. Please refer to the additional information in Appendix E to prevent excessive heating associated with MRI procedures. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure83 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. CAUTION Use only approved pressure transducers and cables, as listed in Accessories in chapter 1, and follow the Instructions for Use that are supplied with the pressure transducer to set up and use the transducer monitoring kit. Note The procedure below details the connection of a single transducer. To monitor two IBP channels, repeat the procedure to connect an additional transducer to the unused IBP port on the MR400. Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631) I. Connecting the Reusable Cable to the MR400 Connectthereusablecable,REF989803194601(orequivalent),totheP1ortheP2portonthe patientconnectionpanel. P1 port P2 port Reusable cable

(REF 989803194601, or equivalent) 84MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse II. Kit Set Up Setupthedisposabletransducermonitoringkitusingaseptictechnique. Step Action 1 2 3 4 5 Openpackagecontainingthesteriledisposabletransducer monitoringkit. Removetransducermonitoringkitassemblyfromthepackage. Checkallfittingstoensuretightconnection. Connectthereusablecable,REF989803194601(orequivalent),to thetransducercable. Reusable cable

(REF 989803194601, or equivalent) Transducer cable Transducer PrepareacollapsibleI.V.solutionbagbyextractingallairfromthe bag.Ifheparinizing,addheparinpriortoairremoval. CAUTION If an air-free solution source is not used (i.e., air is not extracted from the fluid source), air may be forced into the monitoring line when solution is exhausted. Closetheclampontheadministrationsetandremovethe protectivecapfromtheadministrationsetspike.Insertthespike carefullyintotheI.V.solutionbag. CAUTION To prevent inadvertent puncture of the I.V. solution bag, insert the spike carefully using a twisting motion. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure85 Step Action 6 7 8 9 InserttheI.V.solutionbagintothepressureadministrationcuff. HangthepressureadministrationcufffromanMRI.V.pole. Withtheadministrationsetclampclosed,gentlysqueezethedrip chamberandfilldripchamberapproximately1/2full. Openclamponadministrationset. III. Purging Air from the Monitoring Line A. B. AttachthetransducertoanMRIVpolemount. Turnzeroreferencestopcockofftopatient.Removewhiteventedcapfromthesideport ofthezeroreferencestopcock. C. Activatefastflushmechanismofthecontinuousflushdeviceandfilltransducerslowly

(gravityprimeonly)untilairfree.Flushfluidthroughtransducerandsideportofstopcock. D. E. F. Turnhandleofzeroreferencestopcockofftoitssideport.Placeayellownonventedcap ontothesideportofthestopcock. RepeatprimingstepsBDforanyadditionalstopcocks. Removewhitecoveratpatientconnectorandflushtherestofthepatientline.Placea yellownonventedcoverontothepatientconnector. Note Take care to ensure no air is trapped in any components of the fluid pathway. The monitoring system must be totally air-free for maximum performance, i.e., optimal dynamic response. G. PressurizetheI.V.solutionsourceto300mmHg.Closeclamponpressurecuff. CAUTIONS Make certain the drip chamber does not completely fill during pressurization. Air should remain in the drip chamber so that the continuous flush rate can be verified following a fast flush. Pulling a vacuum to purge bubbles from the lines is not recommended. This practice may entrain air or release air from solution. If the line is primed in a forward manner under pressure, care must be taken to assure the maximum pressure specifications for the transducer are not exceeded. 86MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse IV. Zeroing, Leveling and Calibration A. Afterthesystemhasbeenprimedandmounted,zerothetransducerusingoneofthe followingmethods:

Step Action 1 2 Turnthezeroreferencestopcockofftothepatientandremove yellownonventedcapfromthesideportwhichopensthezero referencestopcocktoair. Note The air-fluid interface of the zero reference stopcock should be at or near the right atrial (mid-axillary) level. Zerothetransducer.PresstheZeroAllkey.(Otherwise,tozeroa singlechannel,useZeroSetintherespectiveP1orP2menu;see page824). ZeroingAllPressureChannels(orZeroingPressureChannelfora singlechannelifZeroSetwasused)willbedisplayedandzeroing willbegin;where,uponcompletion,Donewillbedisplayedto indicatesuccess. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturers instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. 3 Turnthezeroreferencestopcockofftothesideportandreplace yellownonventedcap. Or Step Action 1 2 Attachdesiredcathetertodistalendofmonitoringkitandprime, purgingallairbubblesfromcatheter. Openstopcock(s)tothecatheter.(Thecathetertipisnowthe systemairfluidinterface.) ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure87 Step Action 3 4 5 Placetransducerintheposition(horizontalplane)itwillmaintain duringpressuremeasurement. Placethecathetertipattherightatrial(midaxillary)level. Zerothetransducer.Zerothetransducer.PresstheZeroAllkey.

(Alternatively,useZeroSetintherespectiveP1orP2menutozero aspecificchannelconnectedtothetransducer;seepage824). ZeroingAllPressureChannels(orZeroingPressureChannelfora singlechannelifZeroSetwasused)willbedisplayedandzeroing willbegin;where,uponcompletion,Donewillbedisplayedto indicatesuccess. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturers instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. B. Repeatthiszeroing,leveling,andcalibrationprocedureforeachadditionalmonitoringline asapplicable. C. Transducersareprecalibratedtoindustrystandards. V. Connecting the Monitoring Kit to the Patient WARNING The IBP transducer must not be mounted to the patient, or patient burn may result. A. B. Removeyellownonventedcoveratpatientconnector.Acontinuousflushofapproximately 3mlperhourshouldbeobservedinthedripchamber.Droprateshouldbeapproximately1 dropperminute.Foreachadditionalmonitoringline,thecontinuousflushwillincreaseby3 ml/hr(i.e.,6ml/hrfortwolines). Forasystemicarterialbloodpressureline,activatethefastflushmechanismofthe continuousflushdevice,whileallowingarterialcannulatobackflowduringattachment.For pulmonaryarterycatheters,themonitoringkitshouldbeattachedtothecatheterandthe 88MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse catheterfilledwithI.V.solutionpriortoinsertion.Followcathetermanufacturersinsertion instructions. VI. Fast Flushing A. B. Activatethefastflushmechanismofthecontinuousflushdeviceandcheckdripchamberto confirmfastflush. FOLLOWINGEACHFASTFLUSH,DRIPCHAMBERDROPRATEMUSTBEOBSERVEDTO VERIFYCOMPLETECLOSURE. VII. Checking for Leaks Afterapproximately1minutehaselapsed,theflowrateshouldbeobservedatthedripchamber toensurethatthecontinuousflushdeviceisoperatingproperly.Avisualinspectionforleaks shouldalsobemadesinceasmallleakcanmisrepresenttheactualcontinuousflowthroughthe catheter.Aprotocolshouldbeestablishedaccordingtothehospitalstandardofcareforroutinely checkingthesystemforproperfluidsourcepressure,flowrateandleaks. VIII. In the MR Room WARNINGS The IBP transducer must not be allowed past the 5,000 gauss line, or transducer failure, inaccurate readings, noisy MRI images or patient burn may result. Never place the pressure transducers stopcocks or port covers within 8 cm (3.2 inches) of the field of view of the MR bore as inaccurate readings or noisy MRI images can result. An offset occurs when the pressure transducer is repositioned in the magnetic field. The transducer must be zeroed prior to the MRI examination after the transducer is in its final setup position. Moving the transducer after zeroing may cause a measurement offset to occur. IntheMRroom,ensurethatthetransducerislevelwiththeheartthatthetransducerinterface cablingisnotloopedortouchingthepatient(refertheWarningsonpages83and84),andthen rezerothetransducer;seepage816. WARNING Non-physiological pulsatile P1 (or P2) waveform (for example, those found during intra-

aortic balloon pump use) can lead to inaccurate blood pressure readings. If questionable values are observed, recheck the patients pressures by alternate means before administering medication or therapy. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure89 Note When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for leaks after zeroing, and always follow the pressure transducer/catheter manufacturers use recommendations. Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641) I. Connecting the Reusable Cable to the MR400 Connectthereusablecable,REF989803194601(orequivalent),totheP1ortheP2portonthe patientconnectionpanel. P1 port P2 port Reusable cable

(REF 989803194601, or equivalent) II. Kit Set Up A. Setupthedisposabletransducermonitoringkitusingaseptictechnique Step Action 1 2 3 4 Openpackagecontainingthesteriledisposabletransducermonitor ingkit. Removetransducermonitoringkitassemblyfrompackage. Attachadditionalmonitoringcomponentsasdesired. Checkallfittingstoensuretightconnections. 810MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse Step Action 5 Connectthereusablecable,REF989803194601(orequivalent),to thetransducercable. Reusable cable

(REF 989803194601, or equivalent) Transducer cable Transducer B. PreparingSolution Step Action 1 2 3 Assemblepumpadministrationsetappropriatefortheinfusion pumpthatistobeused. Ifusingheparin,addpriortoairremoval. CAUTION If an air-free solution source is not used (i.e., air is not extracted from the fluid source), air may be forced into the monitoring line when solution is exhausted. Attachtubingtosolutioncontainerandprimethetubingfollowing pumpmanufacturersinstructions. Note If an air-free solution source is not used (i.e., air is not extracted from the fluid source), air may be forced into the monitoring line when solution is exhausted. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure811 C. ConnectingKittotheInfusionPump Step Action 1 Removeventedcapfromthefemaleportofflushdeviceandcon nectflushdevicefluidlinetodistalconnectorofinfusionpump administrationset. CAUTION In this application, the flush device is not intended to control flow rate. Flow rate must be controlled by an infusion pump. Do not use with pressure administration cuff. III. Purging Air from the Monitoring Line A. Removetheventedcapfromthestopcocksandtheventedcoverfromthepatientconnector

(distalstopcock). B. Adjustthepumpdeliveryregulatortoafluidflowratesufficienttoflushsolutionthroughthe system. C. CarefullyfillfluidlinesofthemonitoringkitwithI.V.solutionuntilallairhasbeenremoved fromthesystem.Activateflushdevicetofacilitatefillingandtoremoveairfromflushdevice. Turnstopcockhandlesasapplicabletoprimethroughsideportsofstopcocks.Nonvented capsandcoversareprovidedinthesparepartsbagtoreplaceventedcapsandcoversas required. CAUTION Pulling a vacuum to purge bubbles from the lines is not recommended. This practice may entrain air or release air from solution. If the line is primed in a forward manner under pressure, care must be taken to assure the maximum pressure specifications for the transducer are not exceeded. Note Take care to ensure no air is trapped in any components of the fluid pathway. The monitoring system must be totally air-free for maximum performance, i.e., optimal dynamic response. IV. Zeroing, Leveling and Calibration A. After the system has been primed and mounted, zero the transducer using one of the followingmethods:

812MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse Step Action 1 2 Turnthezeroreferencestopcockofftothepatientandremove nonventedcapfromthesideportwhichopensthezeroreference stopcocktoair. Note The air-fluid interface of the zero reference stopcock should be at or near the right atrial (mid-axillary) level. Zerothetransducer.PresstheZeroAllkey.(Otherwise,tozeroa singlechannel,useZeroSetintherespectiveP1orP2menu;see page824). ZeroingAllPressureChannels(orZeroingPressureChannelfora singlechannelifZeroSetwasused)willbedisplayedandzeroing willbegin;where,uponcompletion,Donewillbedisplayedto indicatesuccess. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturers instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. 3 Turnthezeroreferencestopcockofftothesideportandreplace nonventedcap. Or Step Action 1 2 3 4 Attachdesiredcathetertodistalendofmonitoringkitandprime, purgingallairbubblesfromcatheter. Openstopcock(s)tothecatheter.(Thecathetertipisnowthesys temairfluidinterface.) Placetransducerintheposition(horizontalplane)itwillmaintain duringpressuremeasurement. Placethecathetertipattherightatrial(midaxillary)level. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure813 Step Action 5 Zerothetransducer.PresstheZeroAllkey.(Alternatively,useZero SetintherespectiveP1orP2menutozeroaspecificchannel connectedtothetransducer;seepage824). ZeroingAllPressureChannels(orZeroingPressureChannelfora singlechannelifZeroSetwasused)willbedisplayedandzeroing willbegin;where,uponcompletion,Donewillbedisplayedto indicatesuccess. Note If the transducer will not zero and an error condition occurs, verify that the transducer is being used as described in the manufacturers instructions. Press Retry to attempt zeroing again. If the transducer still does not zero, try another transducer and/or cable; and, if condition persists, contact technical support or authorized service personnel. B. Transducersareprecalibratedtoindustrystandards. V. Connecting the Monitoring Kit to the Patient WARNING The IBP transducer must not be mounted to the patient, or patient burn may result. A. B. Removenonventedcoveratpatientconnector. Settheinfusionpumptodeliverthedesiredflowrate.Continuouslowflowflushshouldbe observedatthepatientconnectoranddripchamber(ifprovided)atthistime. CAUTION Kits with a 30 ml per hour flush device are not intended to control flow rate. Flow rate must be controlled by an infusion pump. Do not use with pressure administration cuff. C. Activatepumpdeliverymechanismtopumpsolutionthroughtheflushdevicewhileallowing arterialcannulatobackflowduringattachment. 814MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse CAUTIONS Be certain not to introduce air into the system during connection procedure. If this product is used with fat emulsions, they must be introduced through the lipid compatible stopcock that is distal to the flush transducer assembly to avoid cracking of the transducer line. VI. Checking for Leaks Afterapproximately1minutehaselapsed,theflowrateshouldbeobservedatthedripchamber toensurethatthecontinuousflushdeviceisoperatingproperly.Avisualinspectionforleaks shouldalsobemadesinceasmallleakcanmisrepresenttheactualcontinuousflowthroughthe catheter.Aprotocolshouldbeestablishedaccordingtothehospitalstandardofcareforroutinely checkingthesystemforproperfluidsourcepressure,flowrateandleaks. VII. In the MR Room WARNINGS The IBP transducer must not be allowed past the 5,000 gauss line, or transducer failure, inaccurate readings, noisy MRI images or patient burn may result. Never place the pressure transducers stopcocks or port covers within 8 cm (3.2 inches) of the field of view of the MR bore as inaccurate readings or noisy MRI images can result. An offset occurs when the pressure transducer is repositioned in the magnetic field. The transducer must be zeroed prior to the MRI examination after the transducer is in its final setup position. Moving the transducer after zeroing may cause a measurement offset to occur. IntheMRroom,ensurethatthetransducerislevelwiththeheartthatthetransducerinterface cablingisnotloopedortouchingthepatient(refertotheWarningsonpages83and84),and thenrezerothetransducer;seepage816. WARNING Non-physiological pulsatile P1 (or P2) waveform (for example, those found during intra-

aortic balloon pump use) can lead to inaccurate blood pressure readings. If questionable values are observed, recheck the patients pressures by alternate means before administering medication or therapy. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure815 Note When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for leaks after zeroing, and always follow the pressure transducer/catheter manufacturers use recommendations. Zeroing the Pressure Transducer WARNING The transducer must be zeroed prior to the MRI examination after the transducer is in its final setup position. Moving the transducer after zeroing may cause a measurement offset to occur. Otherwise, inaccurate patient pressure readings may result. Toavoidinaccuratepressurereadings,themonitorrequiresavalidzero.Zerothetransducerin accordancewithyourhospitalpolicy(atleastonceperday).Youmustperformazero:

whenyouuseanewtransducerortubing, everytimeyoureconnectthetransducercabletothemonitor,or ifyouthinkthemonitorspressurereadingsarenotcorrect. Tozeroapressuretransducer Refertotheappropriateprocedureaccordingtothepatienttypeandapplication:

Adult/Pediatricseepage87. Neonateseepage812. P1 and P2 Waveforms and VS Boxes Invasivebloodpressuremeasurements(P1andP2)aredisplayedaswaveforms(traceEandtrace F,respectively)intheVStraceareaofthescreenandasnumericinformationintheP1andP2VS boxes.Otherdata,includingP1andP2relatedalarminformation,arealsoprovidedinthese areasofthescreen,asdetailedbelow. 816MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse Note Except for the VS box annotations and waveform locations, the definitions described below are applicable to both P1 and P2 channels. Systolic/Diastolic Format 1 2 3 4 5 6 7 8 9 12 11 10 Item Name Definition 1 2 3 4 5 6 7 8 P1 VS waveform, or P2 VS waveform Is the detected P1 (or P2) waveform, Trace E (or Trace F) Note To change the waveform speed, see Sweep Speed on page 3-25. Alarm flag area Displays P1 (or P2) alarm flags when detected; see page 4-31. P1 (or P2) VS box label Unit of measure Indicates the P1 (or P2) vital sign parameter, and accesses the P1 menu (or P2 menu) Indicates that the pressure measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see Pressure Units on page 3-32. Systolic numeric Is the patients detected systolic invasive blood pressure measurement Diastolic numeric Is the patients detected invasive diastolic blood pressure measurement Systolic upper alarm limit Diastolic upper alarm limit Is the upper limit setting for the P1 (or P2) systolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) Is the upper limit setting for the P1 (or P2) diastolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure817 Item Name Definition 9 Diastolic lower alarm limit 10 Systolic lower alarm limit Is the lower limit setting for the P1 (or P2) diastolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) Is the lower limit setting for the P1 (or P2) systolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 11 Mean numeric Indicates the patients detected mean invasive blood pressure measurement 12

<P1 label> or <P2 label>

Indicates the Set Label name, if assigned, for P1 (or P2) Mean Format 1 2 3 4 5 6 7 10 9 8 Item Name Definition 1 2 3 4 5 6 P1 VS waveform, or P2 VS waveform Is the detected P1 (or P2) waveform, Trace E (or Trace F) Note To change the waveform speed, see Sweep Speed on page 3-25. Alarm flag area Displays P1 (or P2) alarm flags when detected; see page 4-31. P1 (or P2) VS box label Unit of measure Indicates the P1 (or P2) vital sign parameter, and accesses the P1 menu (or P2 menu) Indicates that the pressure measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see Pressure Units on page 3-32. Mean numeric Is the patients detected mean invasive blood pressure measurement Mean upper alarm limit Is the upper limit setting for the P1 (or P2) mean alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 818MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse Item Name Definition 7 8 9 Mean lower alarm limit Is the lower limit setting for the P1 (or P2) mean alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) Diastolic numeric Is the patients detected invasive diastolic blood pressure measurement Systolic numeric Indicates the patients detected systolic invasive blood pressure measurement 10

<P1 label> or <P2 label>

Indicates the Set Label name, if assigned, for P1 (or P2) Changing the P1 (or P2) Format TocontroltheformatoftheP1(orP2)data Step 1 Action SelecttheP1(orP2)VSbox. TheP1menu(ortheP2menu)appears.Currentsettingsare displayed. SelectFormat. TheFormatmenuappears.Thecurrentsettingishighlighted. Selectthedesiredformat:

2 3 SysDia Mean Theformatischanged. Note When using P1 (or P2) labels CVP or ICP, the displayed format cannot be changed; see page 8-28 for details. Changing the P1 (or P2) Waveform Amplitude TheverticalscaleofthedisplayedP1(orP2)waveformcanbechangedtobestsuittheviewing requirements.Alwaysselecttheappropriatewaveformscaleforthewaveformbeingobserved. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure819 TochangetheP1(orP2)waveformamplitude Step 1 Action SelecttheP1(orP2)VSbox. TheP1(orP2)menuappears.Currentsettingsaredisplayed. SelectSize. TheSizemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsize:

2 3 40mmHg 75mmHg 100mmHg 150mmHg(Default) 200mmHg 250mmHg Thesettingischanged. Changing the P1 (or P2) Alarm Limits TheP1AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheP1vitalsign box,andtheP2AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheP2 vitalsignbox.Exceptformenulabelingdifferences,theelementsdescribedbelowareapplicable toboththeP1andP2parameters. 7 8 9 10 11 12 1 6 5 4 23 Alarm limit settings, P1 VS box 1 2 High button Low button 3 P1 Diastolic Alarm Limits menu label 4 P1 Mean Alarm Limits menu label 5 Enter button 6 820MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse 7 8 9 10 11 12 Current adjustment P1 Systolic Alarm Limits menu label (active adjustment shown) Alarm limit, minimum Lower P1 (Sys) alarm limit setting Upper P1 (Sys) alarm limit setting Alarm limit, maximum Tochangetheinvasivebloodpressurealarmlimitsettings Step 1 Action SelectthealarmlimitsettingsintheP1(orP2)VSbox. TheP1AlarmLimits(ortheP2AlarmLimits)menuappears. Currentsettingsaredisplayed. Selectthedesiredpressuresetting:

P1(Sys) P1(Dia) P1(Mean) Thesettingisselected. SelecttheLowbuttonortheHighbutton. Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. Thecurrentadjustmentwillreflectthechange. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangetheremainingsettings,repeatsteps2,3,4and5. Thecurrentadjustmentwillreflectthechange. 2 3 4 5 6 Note See chapter 4 for detailed alarm limit setting instructions and options. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure821 Changing the Unit of Measure Note When using an 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 measurement numeric values to reflect the new unit of measure. Do not print or perform data captures during this period. Tochangetheunitofmeasure Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)menuappears.Currentsettingsare displayed. OntheService(BioMed)menu,selectSystemConfig. TheSystemConfigmenuappears.Currentsettingsaredisplayed. OntheSystemConfigmenu,selectPressureUnits. ThePressureUnitsmenuappears.Thecurrentsettingis highlighted. Selectthedesiredsetting:

2 3 4 5 mmHg kPa Thesettingisentered. P1 (and P2) Menu TheP1andP2menusallowyoutocontrolinvasivebloodpressuretraces,functionsandsettings. Eachmenucontainsidenticaloptionsforthecontroloftherespectiveinvasivebloodpressure channel,P1orP2. Note The operation and menus for P1 and P2 are identical. 822MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse ToopentheP1menu(orP2menu) SelecttheP1VSbox(ortheP2VSbox). P1 menu P1 VS box ThefollowingP1(andP2)menuitemsare available:. Zero Set Set Label Size 1 2 3 4 HR Source 5 6 7 Grids Grids Size Format 1 2 3 4 5 6 7 TochangesettingsintheP1(orP2)menu Step 1 Action SelecttheP1(orP2)VSbox. TheP1(orP2)menuappears.Currentsettingsaredisplayed. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure823 Step 2 Action TouchthemenuitemtoselectoneofthefollowingP1(orP2) options:

ZeroSet SetLabel Size HRSource Grids GridsSize Format Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptGrids, whichisselectableontheP1[orP2]menu):

Thesettingisentered. Tochangeothersettings,repeatsteps2and3. 3 4 Zero Set ZerosthepressuretransducerforP1(orP2).Thepressuretransducermustbezeroedbeforeuse andatregularintervalsduringuse.(ZeroPressureChannelwillbedisplayedduringtheprocess andDonewillbedisplayeduponcompletion.) Tozerothepressuretransducer SeeZeroingthePressureTransduceronpage816. Set Label Assignsalabeltothepressurechannelforidentificationofthetransducersite.Thelabelwill appearintheVSboxanditwillalsodeterminethecolorusedfortheVSbox. Thefollowingnamesandcolorsareavailable:

Nonedisplayedinwhite.(Default) ABP(arterialbloodpressure)displayedinpink. Note In the event ABP is chosen as the heart rate source while there are multiple pressures labeled as ABP, the system will choose P1. PAP(pulmonaryarterypressure)displayedinyellow. 824MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse CVP(centralvenouspressure)displayedinblue. LAP(leftatrialpressure)displayedinpurple. ICP(intracranialpressure)displayedinlightblue. ToassignalabeltoanP1(orP2)channel Step 1 Action SelecttheP1(orP2)VSbox. TheP1menu(ortheP2menu)appears.Currentsettingsare displayed. SelectSetLabel. TheSetLabelmenuappears.Thecurrentsettingishighlighted. Selectthedesiredlabel:

2 3 None ABP PAP CVP LAP ICP Thelabelischanged.TheannotationintheVSboxanditscoloris updated. Size ChangestheP1(orP2)waveformamplitude,allowinglowlevelsignalstobescaleduporhigh levelsignalstobescaleddownforbetterviewing. Thefollowingoptionsareavailable:

40mmHg 75mmHg 100mmHg 150mmHg(Default) 200mmHg 250mmHg TochangetheamplitudeoftheP1(orP2)waveform SeeChangingtheP1(orP2)WaveformAmplitudeonpage819. ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure825 HR Source Selectsthesourcethatproducestheheartrate,asdisplayedintheECGandSPO2VSboxes

(identicaltoandinteractivewithsameoptionintheECGandSPO2menus). Thefollowingoptionsareavailable:

Autosetsthesourceautomaticallyaccordingtothehighestpriorityactiveinputthatisfirst toreportvalidpatientdata.Thepriorityranking(highesttolowest)isECG,P1,P2,SPO2

(providedthattheP1andP2channelshavebeenlabeledABP;seeSetLabelonpage824 fordetails).Thesourcewillbecomeunavailablewhenithasproducednovaliddatafora periodoften(10)ormoreseconds.Thesystemexaminesthehighestpriorityactiveinput. Ifnotfound,thesecondhighestpriorityinputischosen,etcetera.Ifnonearepresent, thenNoneisdisplayedastheheartratemeasurementnumeric. ECGsetsECGasthesource.(Default) ABPsetsABPasthesource(ifnopressurechannelislabeledABP,awarningboxwillallow automaticrenamingandselectionbeforeproceeding;alsoseeSetLabelonpage824). SPO2setsSPO2asthesource. Tosettheheartratesource Step 1 Action SelecttheP1(orP2)VSbox. TheP1menu(ortheP2menu)appears.Currentsettingsare displayed. SelectHRSource. TheHRSourcemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfortheheartratesource:

2 3 Auto ECG ABP SPO2 Thesourceischanged. Grids ControlsthepressuregriddisplayforIBPwaveforms. 826MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse Grids Size Grid Thefollowingoptionsareavailable:

Offnogridisdisplayed.(Default) Ondisplaysascaledgrid(alsoseeGridsSize,below). Tocontrolthedisplayfunctionforthepressuregrid Step 1 Action SelecttheP1(orP2)VSbox. TheP1menu(ortheP2menu)appears.Currentsettingsare displayed. LocateGridsandselectthedesiredsetting:

2 Off On Thesettingisentered. Grids Size SetsthescalesizewhenGridsison(seeGrids,above). Thefollowingoptionsareavailable:

40mmHg 75mmHg 100mmHg 150mmHg(Default) 200mmHg 250mmHg ExpressionMR400InstructionsforUse MonitoringInvasiveBloodPressure827 ToadjustthegridsizefortheP1(orP2)waveform Step 1 Action SelecttheP1(orP2)VSbox. TheP1menu(ortheP2menu)appears.Currentsettingsare displayed. SelectGridsSize. TheGridsSizemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsize:

2 3 40mmHg 75mmHg 100mmHg 150mmHg 200mmHg 250mmHg Thesettingischanged. Format SetsthedisplayedformatoftheP1(orP2)numericdata,exceptwhenusingcertainpressure channellabels. Thefollowingoptionsareavailable:

SysDiadisplaysthesystolicanddiastolicnumericsinalargefont(separatedbyaslash)and displaysthemeannumericinasmallerfont(bracketedwithparenthesis).(Default) Meandisplaysthemeannumericinalargefont,andthesystolicanddiastolicnumericsin asmallerfontandseparatedbyaslash.Onlymeanalarmswillbepresentinthisformat. Also,labels(i.e.,CVPandICP)thatdesignatesinglepressureswillautomaticallyassumethe meanformat;seeSetLabelonpage824. TocontroltheformatoftheP1(orP2)numericdata SeeChangingtheP1(orP2)Formatonpage819. 828MonitoringInvasiveBloodPressure ExpressionMR400InstructionsforUse Monitoring Agents and Gases (AGENT Option) CHAPTER 9 WhenequippedwiththeAGENToption,thepatientslevelofanestheticagentgases,oxygen

(O2),carbondioxide(CO2),andnitrousoxide(N2O)concentrationscanbemonitored.An anestheticgassensor(AGS)systemusesinfraredspectroscopycombinedwithdigitalsignal processingtoquicklyandaccuratelyidentifygasconcentrations. WARNING Whenever a patient is under anesthesia or connected to a ventilator, constant attention by qualified medical personnel is required. MR400 Preparation for AGENT Monitoring WhenpreparingtheMR400forAGENTmonitoring,ensurethatthewastegasport(seepage1 19)hasbeenconnectedtoyourfacilitysgasscavengingsystemfordisposalofsampledand calibrationgases. Notes These instructions are for setting up a typical monitoring system. Exact components and set-

up procedure used may vary, depending upon the application. For components added to the monitoring system, refer to applicable manufacturers instructions for set up and use. Never route the waste gas tubing in a location that will allow it to be an obstruction or stepped on. Operation and Use Whenmonitoringanestheticagentgases,thetypicaloperationsandpossibleconditionsthatcan arisemayresultinpotentialmessagesrequiringyourattention.Seepage426foramessage listingandsuggestedactions. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)91 WARNINGS Organic vapors (for example, from cleaning agents) in the sampling line or room air may alter anesthetic agent readings. Alcohol in the patients breath can modify the anesthetic agent readings. Warm-Up Period Inordertoachieveaccurateidentificationsandmeasurements,theAGSsystemrequiresawarm upperiodtothermallystabilize.ThiswarmupperiodbeginswhentheAGENTortheCO2 parameterisactivated.Uponactivation,theAGSsystemwillbecomefullyoperationalaccording tothefollowingsequence:

1. Duringthewarmupperiod,CO2WarmingUpwillbedisplayed. 2. Within45secondsofactivation,theAGSsystemwillbeabletoidentifythegasesand providegasconcentrationinformationwithISOlevelaccuracy.Waitduringthisperiod,the measurementnumericvaluesintheAGENT,GAS,andCO2VSboxeswilldisplaythree dashes();seeNoDataIndicationonpage220fordetails. 3. Within10minutesofactivation,theAGSsystemwillbeabletooperateatfullaccuracy. Zero Reference Adjustment WARNING During Zero calibration the system pulls ambient air through the zero intake port on the cart The calibration system assumes that the ambient air will contain normal trace amounts of CO2. If the system is placed in an unventilated area that allows CO2 (from the waste gas port on the rear panel, if not connected to a gas scavenging system) to accumulate, the result could be inaccurate CO2 zeroing and resulting inaccurate patient readings. Always place the cart in a well ventilated area. TheAGSsystemwilloccasionallyperformazeroreferenceadjustment,brieflyinterruptinggas monitoringtotakeinroomairthroughareferencegasintakeporttoensuretheaccuracyofthe displayedgasconcentrations. ReadjustingCO2Zerowillbedisplayedduringazeroreferenceadjustment;allowtheprocessto complete.Azeroreferenceadjustmenttypicallytakes1012seconds,andwilloccur automaticallyasneeded,butmostlyduringthewarmupperiod.WhentheAGSsystemhas becomefullyoperational,theseadjustmentswilloccurapproximatelyonceevery4hoursor whenevertheAGSsystemtemperaturechangesbyatleast1Cfromthelaststoredstable temperature. 92MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse Note Whenever the Agent sensor changes from a steady state condition, the system will perform an zero reference adjustment to restabilize the sensor readings. During this time it is possible for a false identification and concentration value to occur. Change from a steady state condition may occur when:

Applying a sampling line for the first time. Switching from one agent to another. Going from high agent concentrations to low or off. Note During the first hour after the system has been turned on and flowing oxygen greater than 50 percent, the CO2 waveform periodically baselines to complete reference measurement; however, the measurement numeric values remain. Once the system reaches ambient temperature this condition will cease to occur. Toperformamanualzeroreferenceadjustment Step 1 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. SelectZeroCal. 2 Allowtheprocesstocomplete,typically1012seconds. Breath Rate Distortion Theeffectofrisetimedistortiontothegascurvebecomesapparentwhenthebreathingrate increasessothatthetimeforafullinspiratoryorexpiratoryeventgetsshorter.Inthose situations,duetotheeffectoftherisetime,thegascurvedoesnotreachthetrueendtidal(or firstinspiredvalue)andtheendtidalgasvaluemaythenbeunderestimated.Correspondingly, thefirstinspiredvaluemaybeoverestimated.Belowisanexaggeratedillustrationoftheeffect. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)93 Percent

- - at gas sampling site as presented by gas analyzer Et error Fi error Time Thebreathratelimitforaccuratelyresolvedendtidalgasvalues(atanI:Eratioof1:1)maybe foundinAppendixA.TheeffectofotherI:Eratiosmaybecalculatedbydeterminingthelengthof theshortestinspiratory/expiratoryeventthatcanberesolvedaccurately:

tresolved=60/(2xBRlimit(1:1) BRlimit(I:E)=60/((I+E)xtresolved) Thedifferenceintheseresultswhencomparedtotherisetime'sspecificationisthatrisetime's onlytests1090%performance.Thisspecificationisfor(0+accuracy)to(100accuracy)%andis thusmuchtougher.Theabilitytoproperlyresolveendtidalvaluescanbemeasuredbyusingthe setupdescribedinISO80601255:2011figure201.101.Inshort,themethodconsistsof samplinggasfromtwodifferentsourcesconnectedtoanelectricallycontrolledpneumaticvalve topermitrapidswitchingbetweenthetwosources.Duringthetest,thevalveissettoswitchgas sourceatanumberoffrequencies(simulatingtherangeofspecifiedbreathrates)andforeach frequencytheendtidalvaluepresentedbythegasanalyzerisnoted.Fromadiagramofendtidal valueoverfrequency,thefrequencyatwhichthegasanalyzerisnolongerabletoresolveend tidalvaluesaccordingtospecificationisidentified.Thisabilitytoproperlyresolveendtidalvalues islistedinthespecification. CO2 Low Flow and Occlusion Conditions CO2LowFlowwillbedisplayedandanalarmwillsoundintheeventofalowflowcondition

(wheneverthegasflowfallstoanamountthatis10percentlessthanthesampleflowratefor theselectedpatienttype),asshowninthetablebelow. Patient Type Sample Flow Rate Flow Rate when Low Flow is Declared Adult Pediatric Neonate 200 ml/min 200 ml/min 150 ml/min 180 ml/min 180 ml/min 135 ml/min Occlusionwillbedisplayedandanalarmwillsoundintheeventofanocclusioncondition

(wheneverthegasflowratehasfallenbelow40ml/minforatleast1second.Thetypicalcauseof 94MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse thelowflowortheocclusionconditionisduetoapinchedsamplingline,orablockedsampling lineduetoexcessivemoisturefrompatientexpiration. Selecting AGENT Accessories VariousaccessoriesareavailableforusewiththeAGENToption.Forexample,whenmonitoring patientsonabreathingcircuit,asampleoftherespiratorygasisdrawnfromthepatients breathingcircuitthroughanairwayadapterandsamplingline,orwhenpatientsarenotona breathingcircuit,thesampleisdrawnthroughanasalcannula.WhenselectingAGENT accessories(seepage134foralisting),considerthefollowing:

Thetypeofpatient(adult,pediatric,orneonatal) Theconditionofthepatient Whetherthepatientisonabreathingcircuit Whetherthepatientisreceivingsupplementaloxygen Allaccessoriesaresingleuse. AGENT Tubing Preparation VariouspneumaticcircuitconfigurationsforusewiththeAGENToptionareillustratedbelow:

Monitoringusingtheairwayadapter 1 2 3 5 4 1 2 3 4 5 Water trap Sample port (with Luer lock connector) Sampling line Luer lock connector Airway adapter connected to the patient airway ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)95 Monitoringusingthenasalcannula 1 2 4 3 5 1 2 3 4 5 Water trap Sample port (with Luer lock connector) Sampling line Luer lock connector Nasal cannula connected to a patient airway Monitoringusingadividednasalcannula(whendeliveringO2tothepatient) 2 3 4 1 5 6 1 2 3 4 5 6 Water trap Sample port (with Luer lock connector) Sampling line Luer lock connector Large tubing connector to patient O2 source Divided nasal cannula connected to a patient airway 96MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse TopreparetheAGENTtubing Step 1 2 Action Ensurethatthewatertraphasbeeninstalledinthewatertrap receptacle(seepage913forinstallationinstructions). InserttheLuerlockconnectoronthesamplingline(REF94018) intothesampleportonthewatertrapandthentightenthe connector(nomorethanonehalfturnshouldberequired). Sample port Sampling line 3 4 5 6 AccordingthetypeofpneumaticcircuitrequiredtoperformAGENT monitoring,connectthepneumaticcircuititems(seethediagrams above). WhereequippedwithaLuerlock,onlyahalfturnoftheLuerlock connectorshouldberequiredwhereequipped;otherwise,ensure thatanytubingconnectorhasbeenpressedfirmlyontothe associatedadapter. Verifythateachconnectionistightbyholdingthenasalprongs(or thepatientairwayadapter)closetoyourearandlisteningfora hissingsound. Increasetheflowtemporarilyifnecessaryandthenreducetothe prescribedflowrateoncetheflowisverified. Onadailybasis,performasystemtest;seepage98fordetails. Applythesamplinglinetothepatient(seepage910). ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)97 WARNINGS Remove the sampling line from the patient airway whenever nebulized medications are being delivered. Continuous exposure to waste anesthetic gases (including halogenated agents and nitrous oxide) is not recommended. Always connect a line between the systems waste gas port and your facilitys gas scavenging/evacuation system. Avoid venting any waste anesthetic gas directly into the room air as exposure to these gases above the recommended OHSA limits could result. Do not block the waste gas port on the system. Ensure that the exhaust gas is not removed from the system under too strong a vacuum. (To prevent this condition, there must always be an opening to the room air.) Too high a vacuum level will change the operating pressure of the system and cause inaccurate readings or internal damage. Use only approved sampling lines and AGENT accessories, as other sampling lines and accessories will cause inaccurate readings and malfunctions. Replace the sampling line, replace the airway adapter, and inspect the water trap between each patient use. CAUTIONS Do NOT over-tighten the sampling line connection to the water trap; only a half-turn should be needed. Over-tightening this connection may damage the water trap and cause failure of the trap assembly. Regularly inspect the line to facilitys gas scavenging system for deterioration, and replace the line if necessary. Pre-Use System Checks PriortousingthesystemforAGENTmonitoring,itisrecommendedthatthefollowinginitial checksbeperformedatleastonce. Step 1 Action Afterthepneumatictubinghasbeenpreparedasdirectedabove

(page95),turnonthesystemandactivateAGENTintheMonitor Setup>Parametersmenu;seepage318. IfAgentHWFailO2Sensorisdisplayedafteractivationofthe parameter,replacetheO2sensorasdescribedonpage1413. 98MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse Step 2 Action AllowtheAGSsystemtorunandsampleroomairforatleast1 minute.TheFiO2readingdisplayedintheGASVSboxshouldbe approximately21percent. Ifthereadingremainsoutsidethisrangeformorethan1minute afterfirstcheckingthereading,replacetheoxygensensoras describedinchapter14. AfterallowingtheAGSsystemtorunforatleast1minute,pinchor sealtheinputline(tothewatertrap)for5secondsandverifythat Occlusionisdisplayed. 3 Ifthismessagedoesnotappear,checkalltubingconnectionsfor leakageandretest. WARNINGS Always test sampling line adapter for a tight connection and proper operation before attaching to a patient. Over-tightening the sampling line connection may damage the water trap. Tighten the sampling line connector no more than one half-turn. Over-

tightening this connector can cause failure of the water trap assembly and inaccurate patient gas measurements. Inspect water trap and AGENT accessories before use. If the sampling line, connector or sample 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 patient tubing. Avoid kinking of the patient sampling line as 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 AGENT, CO2, O2, N2O values to be too low. Always connect all components securely and check for leaks according to standard clinical procedures. Displacement of the nasal cannula or patient airway adapter can cause lower than actual readings. If AGENT, CO2, O2, N2O 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. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)99 CAUTION Routinely inspect the hose assemblies for proper attachment and orientation. Replace hose assemblies with cracks, holes, tears, or cuts that could cause leaks in the system. If hose assemblies with damage that could result in leaks are used, prolonged and/or inaccurate patient readings could result. Note Always inspect the patient sampling line after attachment to the MR400. If questionable anesthetic agent gas measurements are observed, recheck the patient connections, the anesthesia gas machine, and/or the vaporizer before readjusting anesthesia delivery. Applying the Sampling Line to the Patient SelecttheAGENTpatientaccessorythatisappropriateforthepatientsizeandapplication. Patientnasalcannulasandsamplinglineswithanairwayadapterareintendedforusewith breathingcircuitsandanesthesiacircuitsthathaveanintegratedairwayadapter. 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. CAUTION 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. Toapplythenasalcannulatothepatient Step 1 2 Action Ensurethatthenasalcannulaisclean,dryandundamaged.Replace thecannulaifnecessary. Positionthecannulaonthepatientsfaceby insertingthenasalprongsintothenostrils. 910MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse Step 3 Action Passthetubingovertheearsandbehindthehead, ensuringthepatientsheadwillnotrestonanypart ofthecannulawhilethepatientislyingdown. 4 5 6 7 Slidethesleevetowardthepatientsheadtoassurea goodfitofthecannula. SelectthePatientType. SeeSelectingthePatientTypeonpage311. Checkthattheconnectionshavebeenmadecorrectlybyverifying thepatientsbreathingeffortswiththedisplayedCO2waveform. WARNING Before completion of patient setup, ensure that the patients breathing efforts coincide with the displayed CO2 waveform. AfterallowingtheAGSsystemtorunforatleast1minute,pinchor sealthesamplinglinefor5secondsandverifythatOcclusionis displayed. Ifthismessagedoesnotappear,checkalltubingconnectionsfor leakageandretest. Toapplythesamplinglineairwayadapter Step 1 Action Ensurethatthesamplinglineisclean,dryandundamaged.Replace thesamplinglineifnecessary. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)911 Step 2 Action Placetheairwayadapterattheproximalendoftheairwaycircuit. CAUTION Always insert the patient sampling line into the water trap 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. 3 4 5 SelectthePatientType. SeeSelectingthePatientTypeonpage311. Checkthattheconnectionshavebeenmadecorrectlybyverifying thepatientsbreathingeffortswiththedisplayedCO2waveform. WARNING Before completion of patient setup, ensure that the patients breathing efforts coincide with the displayed CO2 waveform. AfterallowingtheAGSsystemtorunforatleast1minute,pinchor sealthesamplinglinefor5secondsandverifythatOcclusionis displayed. Ifthismessagedoesnotappear,checkalltubingconnectionsfor leakageandretest. 912MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse Water Trap Replacement Thewatertrapisintendedtoprotectthe AGENTsystemfromhumidity,secretions, bacterialcontaminationanddust.Replacement ofthewatertrapisnecessarywhenthe contentsinthewatertrapreachitsfullline. Water trap Full line CAUTION Always discard the water trap when it becomes filled. Do not attempt to clean or reuse the water trap. Accidental water ingress into the system can affect the gas measurements. Notes The water trap must be checked every 17 hours of use and replaced as necessary. (Dispose of the trap according to your facilitys biohazard procedure.) For optimum fit and compatibility, use only Invivo (Royal Philips) specified parts. Toreplacethewatertrap Step Action Ifasamplinglineisconnected,thenremovethesamplinglinefromthe sampleportonthewatertrap. 1 2 Sample port Whilesimultaneouslypressingbothreleasetabsonthewatertrap, removethewatertrapfromthewatertrapreceptaclethendisposeof thewatertrapproperly. Release tabs Water trap receptacle ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)913 Step 3 Action Withthenewwatertrappositionedsothatthesampleportisfacing towardyou,alignthetrapsreleasetabstothereleasetabslotsinthe watertrapreceptacle.Pressthewatertrapintothewatertrap receptacleuntilaudibleclicksareheardasbothofthereleasetabs lockintothereleasetabslots. Release tab slots Release tabs Sample port Water trap receptacle 4 Attachthesamplinglinetothesampleport. AGENT and GAS VS Boxes AGENToptionmeasurementsaredisplayedinseveralareas:

Primaryandsecondaryagentgasmeasurementsaredisplayedasnumericinformationin theAGENTVSbox. N2O,O2,andMACmeasurementsaredisplayedasnumericinformationintheGASVSbox. CO2measurementsaredisplayedasawaveformintheVStraceareaofthescreenandas numericinformationintheCO2VSboxwheredependingupontheRESP>Source setting,CO2derivedrespirationinformationmayappearintheRESPVSbox. 914MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse CO2 VS box GAS VS box AGENT VS box RESP VS box Multiple (Mixed) Agents Whenevertwoormoreanestheticagentgasesofdetectableconcentrationsaresensedbythe AGSsystemorwhentheagentgasesintheinspiredandendtidalbreathphasesarepurebut differfromoneanother,amultipleagentsconditionexistsandMultipleAgentswillbedisplayed. Itiscommonforamultipleagentsconditiontooccurduringthetransitionfromoneanesthetic agenttoanother,suchaswhenoneagentisusedtoinduceapatientandanotheragentisused tomaintainthesedatedstate. Note Some hydrocarbons (for example, acetone or methane) will cause a Multiple Agents alarm to occur. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)915 AGENT VS Box 1 2 3 6 45 Item Name Definition 1 2 3 4 5 6 Alarm flag area Displays AGENT alarm flags when detected; see page 4-31. Secondary agent Et numeric Secondary agent Fi numeric Primary agent Et numeric Primary agent Fi numeric AGENT VS box label Is the patients detected concentration and type of secondary end-tidal agent, in volume percent *

Is the patients detected concentration and type of secondary fractional inspired agent, in volume percent *

Is the patients detected concentration and type of primary end-tidal agent, in volume percent *

Is the patients detected concentration and type of primary fractional inspired agent, in volume percent *

Indicates the Agent parameter, and accesses the MAC window

*Valuesdisplayedtothenearest0.1percent Notes No data indication is denoted by three dashes (---) in the agent measurement numeric values

(see page 2-20 for an example). When the agent vaporizer is first turned on, it may take 30 90 seconds for agent identification and readings to be displayed. Once identification is established, changes in concentration readings are virtually immediate. With a 200 percent change in concentration, an auto zero will occur and full accuracy of the changed concentration will be accomplished within approximately 30 seconds. For the identified agent gases, these abbreviations (and colors) are used:

Desflurane Des (light blue) Enflurane Enf (orange) Halothane Hal (pink) Isoflurane Iso (purple) Sevoflurane Sev (yellow) 916MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse GAS VS Box 1 2 3 5 4 Item Name Definition 1 2 3 4 5 GAS VS box label Indicates the gas parameter MAC numeric Is the total MAC value (see MAC Window on page 9-20) EtN2O numeric Is the patients detected end-tidal nitrous oxide concentration in percent FiN2O numeric Is the patients detected fractional inspired nitrous oxide concentration in percent FiO2 numeric Is the patients detected fractional inspired oxygen concentration in percent Note No data indication is denoted by three dashes (---) in the numeric values (see page 2-20 for an example). When AGENT is turned on, it may take 3090 seconds for gases identification and readings to be displayed. Once identification is established, changes in concentration readings will be virtually immediate. Changing the AGENT and GAS Alarm Limits TheGasAlarmsmenucanbeaccessedbytouchingtheSetupkeyandthentheAlarmskey.On theAlarmsmenu,selecttheGasAlarmsbutton. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)917 Gas Alarms menu Setup key Alarms key 1 2 3 4 5 6 Gas Alarms button Lowerandupperalarmlimitsettingsforagentsandgasesareillustratedbelow. 12 11 10 9 8 7 1 2 3 4 Sev (Et) (Sevoflurane [End-tidal]) Sev (Fi) (Sevoflurane [Fractional inspired]) Des (Et) (Desflurane [End-tidal]) Des (Fi) (Desflurane [Fractional inspired]) 918MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse 5 O2 (Fi) (Oxygen [Fractional inspired]) 6 N2O (Fi) (Nitrous oxide [Fractional inspired]) 7 8 9 10 11 12 Enf (Fi) (Enflurane [Fractional inspired]) Enf (Et) (Enflurane [End-tidal]) Iso (Fi) (Isoflurane [Fractional inspired]) Iso (Et) (Isoflurane [End-tidal]) Hal (Fi) (Halothane [Fractional inspired]) Hal (Et) (Halothane [End-tidal]) Individualalarmlimitsettingscanbeadjustedbyselectingtheparameterthatyouwantto changeontheGasAlarmsmenu. 1 32 4 5 6 7 9 8 1 2 3 4 5 6 7 Agent or gas alarm limits label (active adjustment shown) Low button Lower alarm limit setting Alarm limit, minimum Upper alarm limit setting Alarm limit, maximum High button ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)919 8 9 Enter button Current adjustment TochangeanindividualalarmlimitsettingintheGasAlarmsmenu Step 1 Action Touchtheagentorgasparameterthatyouwanttochangeonthe GasAlarmsmenu. Theselectionappearsonahighlightedbackground.(HAL[Et]was selectedforthisexample.)Currentsettingsaredisplayed. SelecttheLowbuttonortheHighbutton. Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. Thecurrentadjustmentwillreflectthesetting. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangetheremainingsetting,repeatsteps2,3,and4. Thecurrentadjustmentwillreflectthechange. Tochangeanyremainingalarmlimitsettings,repeatsteps1,2,3, and4. PresstheMainScreenkeytoclosethemenu. 2 3 4 5 6 7 Note See chapter 4 for detailed alarm limit setting instructions and options. MAC Window DetectedanestheticvaporstrengthsoftheexpiredgasescontributetotheMAC(Minimum AlveolarConcentration)valueandareprovidedintheMACwindow. 920MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse WARNING MAC values are empirical, not absolute values. The MAC values correspond to those of healthy adults and cannot be applied to children. Age and other individual factors influencing the behavior of volatile agents are not taken into account. ToopentheMACwindow SelecttheAGENTortheGASVSbox(seepage914forthelocation). Note If AGENT is set to Single in the System Config menu, the MAC window will display Mixed Agents Not Included In MAC Calculation. 1 2 3 4 5 Item Name Definition 1 2 3 Et Gas Id Is the identifier for the given end-tidal gas Concentration Is the current concentration of the given gas, in percent 1 MAC Is the minimum alveolar concentration for the given gas at which 50 percent of a patient population does not respond with movement to a noxious stimulus, such as skin incision; see table below. Gas DES (Desflurane) ENF (Enflurane) HAL (Halothane) ISO (Isoflurane) SEV (Sevoflurane) N2O (Nitrous oxide) 1 MAC Value 6.00 volume%

1.70 volume%

0.77 volume%

1.15 volume%

2.10 volume%

105 percent ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)921 Item Name Definition 4 5

# MAC Is the MAC value that each individual gas contributes to the total MAC value, calculated by C/M, where:

C = the current concentration of the given gas M = the 1 MAC value for the given gas TOTAL MACs Is the total MAC value, which is equal to the sum of the values in the # MAC column, calculated using the following formula:

TOTAL MAC = EtN2O / (1 MAC N2O) +

(Et 1st Agt) / (1 MAC 1st Agt) +

(Et 2nd Agt) / (2 MAC 2nd Agt) Where:

EtN2O = The current value of end-tidal nitrous oxide 1 MAC N2O = The 1 MAC value for nitrous oxide Et 1st Agt = The current concentration of the primary agent gas Et 2nd Agt = The current concentration of the secondary agent gas 1 MAC 1st Agt = The 1 MAC value for the current primary agent gas 2 MAC 2nd Agt = The 2 MAC value for the current secondary agent gas CO2 Waveform and VS Box TheCO2measurementisdisplayedasawaveformintheVStraceareaofthescreenandas numericinformationintheCO2VSbox.Otherdata,includingCO2relatedalarminformation,are alsoprovidedinthisareaofthescreen.(CO2[RESP]informationcanbedisplayedintheCO2VS boxorintheRESPVSbox,asdetailedbelow.) 1 2 3 4 5 6 7 8 9 10 12 11 922MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse Item Name Definition 1 CO2 VS waveform Is the detected CO2 waveform (Trace D) Note To change the waveform speed, see Resp Speed on page 3-25. 2 3 4 5 6 7 8 9 10 11 12 Alarm flag area Displays CO2 alarm flags when detected; see page 4-31. CO2 VS box label Unit of measure Indicates the CO2 vital sign parameter, and accesses the CO2 menu Indicates that the gas measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see page 9-26. FiCO2 numeric Is the patients detected fractional inspired CO2 measurement EtCO2 numeric Is the patients detected end-tidal CO2 measurement EtCO2 upper alarm limit EtCO2 lower alarm limit Respiration rate upper alarm limit Respiration rate lower alarm limit Is the upper limit setting for the end-tidal CO2 alarm, and accesses the CO2

(Et) Alarm Limits menu Is the lower limit setting for the end-tidal CO2 alarm, and accesses the CO2

(Et) Alarm Limits menu Is the upper limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu Is the lower limit setting for CO2-derived respiration rate alarm, and accesses the CO2 (RESP) Alarm Limits menu Respiration rate numeric Is the patients detected respiration rate measurement, as derived from CO2 Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) When Source is set to BEL in the RESP menu (see page 10-5), the CO2 VS box will also contain CO2-derived respiration rate elements, as indicated by the shaded rows and illustration above; otherwise, this information will be displayed in the RESP VS box

(see page 9-25). Changing the CO2 and CO2 (RESP) Alarm Limits TheCO2(Et)andCO2(Fi)AlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettings intheCO2VSbox. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)923 7 8 9 10 11 1 456 3 2 Alarm limit settings, CO2 (Et), CO2 VS box 1 2 High button Low button 3 4 CO2 (Et) Alarm Limits menu label (active adjustment shown) 5 CO2 (Fi) Alarm Limits menu label 6 7 8 9 10 11 Enter button Current adjustment Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum TochangetheCO2(Et)andCO2(Fi)alarmlimitsettings Step 1 Action Selectthe(Et)CO2alarmlimitsettingsintheCO2VSbox. TheCO2AlarmLimitsmenuappears.CurrentCO2(Et)settingsare displayed. SelecttheCO2alarmlimitsmenu,CO2(Et)orCO2(Fi),thatyou wanttochange. Theassociatedmenuappears.Currentsettingsaredisplayed. SelecttheLowbuttonortheHighbutton. 2 3 Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. 924MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse Step 4 Action Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. 5 6 Thecurrentadjustmentwillreflectthesetting. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangetheremainingsettings,repeatsteps25. Thecurrentadjustmentwillreflectthechange. Atthedefaultsetting,theCO2(RESP)AlarmLimitsmenucanbeaccessedbytouchingthealarm limitsettingsintheRESPVSbox. 6 7 8 9 10 1 2 3 5 4 1 High button Low button 2 Alarm limit settings, CO2 (RESP), RESP VS box 3 4 CO2 (RESP) Alarm Limits menu label 5 6 7 8 9 10 Enter button Current adjustment Lower alarm limit setting Alarm limit, minimum Upper alarm limit setting Alarm limit, maximum ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)925 TochangetheCO2(RESP)alarmlimitsettings Step 1 Action SelecttheCO2(RESP)alarmlimitsettingsintheRESPVSbox(or,in theCO2VSbox,seepage922.) TheCO2(RESP)AlarmLimitsmenuappears.Currentsettingsare displayed. SelecttheLowbuttonortheHighbutton. Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. Thecurrentadjustmentwillreflectthesetting. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangetheremainingsetting,repeatsteps2,3,and4. Thecurrentadjustmentwillreflectthechange. 2 3 4 5 Note See chapter 4 for detailed alarm limit setting instructions and options. Changing the Unit of Measure Tochangetheunitofmeasure Step 1 Action PresstheSetupkeyandthentheMonitorkey. 2 3 TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)submenuappears. OntheService(BioMed)menu,selectSystemConfig. TheSystemConfigmenuappears.Currentsettingsaredisplayed. 926MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse Step 4 Action OntheSystemConfigmenu,selectGasUnits. TheGasUnitsmenuappears.Thecurrentsettingishighlighted. Selectthedesiredunitofmeasure:

5 mmHg kPa Thesettingischanged. CO2 Menu TheCO2menuallowsyoutocontroltheCO2(Et)andCO2(RESP)monitoringfunctionsand settings. ToopentheCO2menu SelecttheCO2VSbox. CO2 menu CO2 VS box ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)927 ThefollowingCO2menuitemsareavailable:

1 2 3 Size Grids Zero Cal 1 2 3 Note Apnea and Apnea Time will be in the CO2 menu when bellows (BEL) is the selected RESP >

Source; see page 10-7 for setting details. TochangesettingsintheCO2menu Step 1 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. TouchthemenuitemtoselectoneofthefollowingCO2options:

Size Grids ZeroCal Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptGrids, whichisselectableontheCO2menu). Thesettingisentered. Tochangeothersettings,repeatsteps2and3. 2 3 4 Size ControlsthesizeoftheCO2waveform. Thefollowingoptionsareavailable:

40mmHg(Default) 60mmHg 80mmHg 928MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse ToadjustthegridsizefortheCO2waveform Step 1 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. SelectSize. TheSizemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsize:

2 3 40mmHg 60mmHg 80mmHg Thesettingischanged. Grids Displaysascaledgrid,whichisgraduatedaccordingtotheSizeselectionfortheCO2waveform. Size Grid Thefollowingoptionsareavailable:

Offdoesnotdisplayagrid.(Default) Ondisplaysagrid. Note Grids will not be displayed during a CO2 Accuracy Check; see page 3-30. ExpressionMR400InstructionsforUse MonitoringAgentsandGases(AGENTOption)929 TocontrolthedisplayfunctionoftheCO2grid Step 1 Action SelecttheCO2VSbox. TheCO2menuappears.Currentsettingsaredisplayed. LocateGridsandselectthedesiredsetting:

2 Off On Thesettingisentered. Zero Cal Initiatesazerocalibration(anautomaticfunctionduringnormaluse)oftheCO2systemtoallow forthedifferentcharacteristicsofeachaccessorytype.ZeroCalisnotrequiredwhenswitching samplinglines.Themaximumtimerequiredforcalibrationisapproximately1012seconds. Toperformazerocalibration Seepage92. 930MonitoringAgentsandGases(AGENTOption) ExpressionMR400InstructionsforUse CHAPTER 10 Monitoring RESP WhenequippedwiththeCO2orAGENToption,thepatientsrespirationratecanbemeasuredas thetimeintervalbetweendetectedbreaths.Alternatively,thepatientsrespirationratecanbe measuredusingthepneumaticbellowsandthewSpO2module. Patient Preparation for RESP Monitoring Whenpreparingapatient,themonitoringmethodusedwillimpacttheperformanceand operationoftheRESPparameter. Monitoring Respiration using CO2 CO2derivedrespirationiscalculatedbymeasuringthetimeintervalbetweendetectedbreaths;

seechapter7(ifequippedwiththeLoFlooption)orchapter9(ifequippedwiththeAGENT option)fordetailedmonitoringinformation.ForRESPVSboxfunctionswhenCO2derived respirationisthesource,seepage103. Monitoring Respiration using the Bellows Bellowsderivedrespirationismonitoredbydetectingabdominalorchestwallmotionusingthe pneumaticbellowsdevice(REF989803152791)andthewSpO2module. ThebellowsmaybeusedintheMRsystembore,althoughthemodulemustnotbeplacedwithin theMRsystembore.Notethattherearenoalarmsforthebellowsderivedrespirationrateasit isnotintendedforvitalsignmonitoring. CAUTION If dropped, the wSpO2 module must be verified for correct operation before use; see page 14-12. Note If bellows respiration is turned on while the CO2 is on, bellows respiration rate data will appear in the RESP VS box and CO2 respiration rate data will appear in the CO2 VS box. ExpressionMR400InstructionsforUseMonitoringRESP101 Bellows Preparation Respirationmeasurementsthataredeterminedusingthebellowsmethodmakechestwall expansionveryimportantforaccuratemonitoringofapatientsbreathing.Iftherespiratory signalappearstoweakenbetweenscans,instructthepatienttobreathemoredeeplyduringthe scantocreatemoremovementatthesensorsite. CAUTIONS Avoid excessive bending of the flexible hose, as this can impair respiration detection. Always apply the bellows to the patient prior to connecting the pneumatic respiration hose to the port on the wSpO2 module; otherwise damage to the module can result. Topositiontherespiratorysensor Step 1 2 3 4 5 Action Placethesensoronthepatientsupperabdomenorlowerchest

(whicheverexpandsmostduringinspiration). Afterthepatienthasexhaled,placethevelcrostraparoundthe patientstrunkandsecurethesensorsnuggly. Connecttheflexiblehosefromthebellowstothepneumatic respirationportonthewSpO2module. wSpO2 module Pneumatic respiration port Flexible hose CheckthebatteryindicatoronthewSpO2moduletoensurethat enoughchargeexists:

Greenbatteryindicator=Chargesufficient;proceedtostep6. Redbatteryindicator=Chargelow;proceedtostep5. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) InsertachargedmodulebatteryintothewSpO2moduleandthen recheckthebatteryindicatortoensureasufficientchargebefore proceeding;seepage126. 102MonitoringRESPExpressionMR400InstructionsforUse Step 6 Action CheckthenetworkchannelindicatoronthewSpO2moduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep7. Flashing=Nocommunication;proceedtostep6. 7 8 9 10 Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) EnsurethatthewSpO2moduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129. SelectthePatientType. SeeSelectingthePatientTypeonpage311. Ensurethattheparameterisworkingbycheckingthedisplayed respiratorynumericintheVSbox. PositionthepatientintheMR system,keepingthewSpO2 moduleoutsidetheMR systembore.Ensurethatthe flexiblehoseisroutedaway fromanymovingpartssothat itdoesnotgetcaughtinthe mechanisms(forexample, betweenthetabletopandthe patientsupport). 11 PlacethewSpO2moduleonacushionedsurfacetominimizeMR vibrations. Respiration VS Box DependingupontheSourceselection,respirationmeasurementsaredisplayedasnumeric informationintheRESPVSbox.Otherdata,includingrespirationrelatedalarminformation,are alsoprovidedinthisareaofthescreen,asdetailedbelow. ExpressionMR400InstructionsforUseMonitoringRESP103 WhenRESP>Source>CO2isselected,theCO2derivedrespirationmeasurementand alarmlimitsettings(displayedinthesamecolorastheCO2VSboxdata)willpopulatethe RESPVSbox. 1 2 3 4 7 6 5 Item Name Definition 1 2 3 4 5 6 7 Alarm flag area Displays CO2 (RESP) alarm flags when detected; see page 4-31. Respiration rate upper alarm limit Respiration rate lower alarm limit Source label Is the upper limit setting for the CO2 (RESP) alarm, and accesses the CO2

(RESP) Alarm Limits menu (when Source isCO2) Is the lower limit setting for the CO2 (RESP) alarm, and accesses the CO2

(RESP) Alarm Limits menu (when Source isCO2) Is the source used for the respiration monitoring, where CO2 is CO2-derived;

see page 10-7 Respiration rate numeric Is the patients detected respiration rate measurement Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) RESP VS box label Indicates the respiration vital sign parameter, and accesses the RESP menu WhenRESP>Source>BELisselected,thebellowsderivedrespirationmeasurement

(displayedinwhite)willpopulatetheRESPVSbox. 1 2 3 4 Item Name Definition 1 RESP VS box label Indicates the respiration parameter, and accesses the RESP menu 104MonitoringRESPExpressionMR400InstructionsforUse Item Name Definition 2 3 4 Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) Respiration rate numeric Is the patients detected respiration rate measurement Source label Is the source used for the respiration monitoring, where BEL is bellows-derived;

see page 10-7 Changing the CO2 (RESP) Alarm Limits TochangetheCO2(RESP)alarmlimitsettings:

IfequippedwiththeCO2LoFlooption,seepage79. IfequippedwiththeAGENToption,seepage923. RESP Menu RESPmenuitemsallowyoutocontrolrespirationfunctionsandsettings. ToopentheRESPmenu SelecttheRESPVSbox. ExpressionMR400InstructionsforUseMonitoringRESP105 RESP menu ThefollowingRESPmenuitemsareavailable:. 1 Source 2 Apnea 3 Apnea Time RESP VS box 1 2 3 Note If RESP > Source > BEL, then Apnea and Apnea Time will be in the CO2 menu. TochangesettingsintheRESPmenu Step 1 Action SelecttheRESPVSbox. TheRESPmenuappears.Currentsettingsaredisplayed. 106MonitoringRESPExpressionMR400InstructionsforUse Step 2 Action TouchthemenuitemtoselectoneofthefollowingRESPoptions:

Source Apnea ApneaTime Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptApnea, whichisselectableontheRESPmenu). Thesettingisentered. Tochangeothersettings,repeatsteps2and3. 3 4 Source SelectsthesourceusedtoacquiretherespirationratemeasurementsdisplayedtheRESPVSbox. Thefollowingoptionsareavailable:

CO2calculatestheratebymeasuringthetimeintervalbetweendetectedbreaths.

(Default,whenequippedwiththeCO2orAGENToption) BELcalculatestherateusingapneumaticbellowsthatmeasureschestorabdominal movement.Nowaveformisprovided.(IfequippedwiththeCO2orAGENToption,thenthe CO2respirationrateelementswillappearintheCO2VSbox.) Tocontrolthesourceusedforrespiration Step 1 Action SelecttheRESPVSbox. TheRESPmenuappears.Currentsettingsaredisplayed. SelectSource. TheSourcemenuappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfortherespirationratesource:

2 3 CO2 BEL Thesettingischanged. ExpressionMR400InstructionsforUseMonitoringRESP107 Apnea WARNING The respiration measurement does not recognize obstructive and mixed apneasit only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath. The safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established. Controlstheapneaalarmfunction,whichisdeclaredwhenthepreadjustedtime(seeApnea Time,below)haselapsedsincethelastbreathwasdetected.DeterminedfromCO2only,not bellows.Onceactivated,thealarmwillbedeactivatedwhentherespirationrategoesabove zero. Thefollowingoptionsareavailable:

Offdoesnotreportanapneaalarm. Onreportsanapneaalarmwhendetected.(Default) Tocontroltheapneaalarmfunction Step 1 Action SelecttheRESPVSbox. TheRESPmenuappears.Currentsettingsaredisplayed. LocateApneaandselectthedesiredsetting:

2 Off On Thesettingisentered. Apnea Time Setstheamountoftimetowaitbeforedeclaringthattheapneaconditionexists. Thefollowingoptions(inseconds)areavailable:

20Sec(Default) 25Sec 30Sec 35Sec 40Sec 108MonitoringRESPExpressionMR400InstructionsforUse Tosettheapneatimedelay Step 1 Action SelecttheRESPVSbox. TheRESPmenuappears.Currentsettingsaredisplayed. EnsurethatApneaisOn. IfApneaisnotOn,enablethesettingasdescribedonpage108. SelectApneaTime. TheApneaTimemenuappears.Thecurrentsettingishighlighted. Selectthedesiredtimedelay(inseconds)forthealarmindication:

2 3 4 20Sec 25Sec 30Sec 35Sec 40Sec Thesettingischanged. ExpressionMR400InstructionsforUseMonitoringRESP109 1010MonitoringRESPExpressionMR400InstructionsforUse CHAPTER 11 Monitoring Temperature Whenequippedwiththetemperatureoption,thepatientssurfaceorbodytemperaturecanbe monitoredusingthereusablesensor,FlexTEMPIISensor(Esophageal/Rectal/Axillary,Direct Mode),REF989803194511.TheFlexTEMPIISensor(Esophageal/Rectal/Axillary,DirectMode), hereafterreferredtoasthetemperaturesensor,isdesignedspecificallyforusewithMR400.The componentsofthetemperaturesensorareshownbelow. 1 2 5 4 3 1 2 3 4 5 Sensing tip Leader Connector Jacket retainer Patient segment General Usage Precautions WARNINGS Only use specified temperature accessories as other types or brands may compromise the safety and accuracy of the MR400. Patient injury or loss of monitoring may result if incorrect accessories are used. During long term monitoring sessions (4 hours or more), frequent medical attention must be given to the sensor site for possible pressure tissue necrosis, especially on the tender skin of neonatal patients. ExpressionMR400InstructionsforUse MonitoringTemperature111 CAUTION CAUTION The sensor contains no latex, and is constructed of fiber-optic glass. Always handle the sensor with care to prevent damage, as improper handling can result in inaccurate readings. Never bend any portion of the sensor into a radius of less than 15 mm (0.6 inches). Youshouldobservethefollowinggeneralprecautionswhenusingthetemperaturesensor:

EnsurethatonlytheFlexTEMPIISensor(Esophageal/Rectal/Axillary,DirectMode),REF 989803194511andifneededsensorjackets(REF989803178181)areusedwiththe MR400. Neverimmersetheentiresensorinliquid. Neversterilizethesensor. Donottangle,pullorapplyexcessiveforceortensiontoanyportionofthesensor. Donotexposethesensingtiptotemperaturesabove50C(122F). Donotalterormodifythesensor,asthiscanaffectperformanceandaccuracyandvoid thewarranty. Neverusestrongsolventssuchasacetone,freonorotherindustrialcleanersonthe sensor. Aftereachcleaningandbeforeeachuse,inspectthesensorfordamage(cracks,holes, tears,cuts,etcetera)andalwaysdiscardadamagedsensor. Initial Use Alwayshandlethetemperaturesensorwithcare.Uponreceivingthetemperaturesensor, thoroughlycleananddisinfectthedevicebeforeusingitonapatient.Usesoapandwaterand CaviWipesdisinfectanttowelettesandthesuggestedmethodtocleananddisinfectthesensor, asthewarrantydoesnotcoverdamagecausedbyunapprovedsubstancesormethods;see Cleaning,DisinfectingandInspectingtheAccessories,onpage147,fordetails.Afterward, connectthesensortotheMR400. CAUTION CAUTION The temperature sensor is sold non-sterile. 112MonitoringTemperature ExpressionMR400InstructionsforUse Connecting and Disconnecting the Sensor CAUTION CAUTION When inserting or removing the temperature sensor from the MR400, only use the connector and never pull or apply excessive force or tension to any other portion of the device. Toconnectthetemperaturesensor GraspthesensorconnectorthenaligntheconnectortothetemperatureportontheMR400and pushtheconnectorforwarduntilyoufeelorhearitclickintoplace. 1 2 3 1 2 3 Temperature port Sensor connector Accessory hook Tostorethetemperaturesensor Whennotinuse,looselyloopthesensorandthendrapeitoveranaccessoryhook. TodisconnectthetemperaturesensorfromtheMR400 Graspthesidesoftheconnector,andthenpulltheconnectoroutofthe temperatureport. ExpressionMR400InstructionsforUse MonitoringTemperature113 Temperature Measurements Dependinguponthemonitoringmethod(surfaceorbody),followthecorrespondingprocedure belowtomakeatemperaturemeasurement.Allowatleast2minutesformeasurement stabilization,withorwithoutthesensorcover(jacket). Note A temperature difference exists between a patients surface temperature and body temperature. Making Surface Temperature Measurements Whenmakingsurfacetemperaturemeasurements,placethetemperaturesensoratanaxillary siteaccordingtothestepsbelow. Tomakesurfacetemperaturemeasurements Step 1 2 3 4 5 6 7 8 Action Carefullyuncoilthesensor,usingcaretoavoidknottingorkinking thedevice. Cleananddisinfectthesensor;seeCleaning,Disinfectingand InspectingtheAccessories,onpage147,fordetails. Thoroughlycleananddrythepatientsaxillaryapplicationsite. WARNING Do not place the sensor on or near an open wound. Failure to comply may result in patient infection. Positionthesensingtipofthesensorattheaxillarysitethenapply ittothepatient. Ifdesired,changetheunitofmeasure(Celsiusisthedefault setting);seeTEMPMenu,onpage1110,fordetails. Performthemonitoringprocedure,allowingatleast2minutesfor themeasurementtostabilize;seeTEMPVSBox,onpage118,for details. Aftertheprocedure,removethesensorfromthepatient. Immediatelycleananddisinfectthesensor(seePostMeasurement Processingonpage117). 114MonitoringTemperature ExpressionMR400InstructionsforUse Making Body Temperature Measurements FlexTEMPSystemJacketsaremandatoryforusewiththetemperaturesensorwhenmaking esophagealorrectal(body)temperaturemeasurements.Beforemakingtemperature measurementsatesophagealorrectalsites,coverthesensoraccordingtothestepsbelow. WARNINGS Use of FlexTEMP System Jackets are mandatory when using the sensor for body (i.e., esophageal or rectal) site temperature measurements. Failure to comply may result in patient infection. Always use a new jacket if a different placement area is desired. Once the sensor has been used for esophageal or rectal placement, do not change the location unless a new jacket is installed as patient injury or infection could result. Do not reuse a FlexTEMP System Jacket, as they are designed for single-use only. Failure to comply may result in patient infection. Placing the Temperature Sensor in a Jacket FlexTEMPSystemJacketsaresterilepolyurethanesensorcoversandshouldbehandledaccord ingly.Foroptimalstorage,jacketsshouldremainsealedinsterilepacksinclosedcabinetswherea moderatetemperatureandlowhumidityaremaintained.Whenplacingthesensorinajacket, ensurethatthesensingtipisfullyinsertedandthatthejackettabsextendoverthepatientseg mentofthetemperaturesensor,asdescribedinthestepsbelow. Toplacethetemperaturesensorinajacket Step 1 2 3 4 Action Carefullyuncoilthesensor,usingcaretoavoidknottingorkinking thedevice. Cleananddisinfectthesensor;seeCleaning,Disinfecting,and InspectingtheAccessories,onpage147,fordetails. Opentheindicatedendofajacketpackageenoughtoexposethe jackettabs. Insertthepatientsegmentofthesensorintothejacket.Graspthe jackettabsthencarefullypullthejacketcompletelyoverthe patientsegmentofthesensor. ExpressionMR400InstructionsforUse MonitoringTemperature115 Step 5 Action Ensurethatthepatientsegmentofthesensoriscompletely inserted.Thereshouldbenoexcessspaceatjackettipandthe jackettabsshouldextendoverthesensorsjacketretainer. Jacket tabs Jacket retainer Patient segment Jacket tip 6 7 Ifneeded,securethejackettabstothejacketretainerusing medicaltape.Followthestepsbelowtomakeabodytemperature measurement. Whenreadytoapplythesensortothepatient,peelthejacket packageopenandremovethejacketedsensor,usingcarenotto soilthesterilizedjacket. Forsensorplacementinstructions,seePlacingtheSensoratthe BodySite,below. Placing the Temperature Sensor at the Body Site WARNING When inserting the sensor into the mouth, use care not to scrape or tear the jacket on the patients teeth and ensure that the patient does not bite the sensor, as this could expose the sensor and compromise the infection control features of the jacket. Note During MRI procedures a large amount of radio frequency (RF) energy is present, which may cause a patients body temperature to increase. Whenmakingbodytemperaturemeasurements,placethecoveredsensorattheesophagealor rectalsiteaccordingtothestepsbelow. 116MonitoringTemperature ExpressionMR400InstructionsforUse Tomakebodytemperaturemeasurements Step 1 2 Action Ensurethatajackethasbeenplacedonthesensor(seePlacingthe SensorinaJacket,onpage115). Ifneeded,applylubricanttothejacketforinsertionintothe patient. CAUTION CAUTION Never use petroleum-based lubricants. A water-based lubricant (for example, Surgical Lubricant, REF 989803168891) can be used to facilitate insertion. 3 4 5 6 7 Insertthesensingtipofthesensorintothepatientatan appropriatedepth. WARNING Never insert the sensor beyond the patient segment of the sensor. Insertion beyond the patient segment can lead to difficulties removing the jacket from the patient. Ifdesired,changetheunitofmeasure(Celsiusisthedefault setting);seeTEMPMenu,onpage1110,fordetails. Performthemonitoringprocedure,allowingatleast2minutesfor themeasurementtostabilize;seeTEMPVSBox,onpage118,for details. Aftertheprocedure,removethesensorfromthepatient. WARNING Ensure that the entire jacket is removed from the patient when withdrawing the sensor. Failure to do so can potentially lead to jacket material being left inside the patient. Immediatelycleananddisinfectthesensor(seePostMeasurement Processingonpage117). Post-Measurement Processing Aftermonitoringtemperature,processthesensorasfollows. ExpressionMR400InstructionsforUse MonitoringTemperature117 Toprocessthetemperaturesensorafteruse Step 1 2 3 Action Ifajacketwasplacedonthesensor,removethejacket andanymedicaltape(ifused).Refertoyourfacilitys biohazardprocedurefordisposalofusedjacketsand medicaltape.Typically,jacketsandtapearedisposed ofasmedicalwasteperfacilityproceduresdueto contaminationconcerns. Thoroughlycleananddisinfectthesensor;seeCleaning, Disinfecting,andInspectingtheAccessories,onpage147,for details. Storethesensor;seeConnectingandDisconnectingtheSensor,on page113,fordetails. Accuracy Check Nocalibrationofthetemperaturesensorisrequired.Iftheaccuracyofameasurementisin questionorifaproblemissuspectedwiththetemperatureoption,performtheuserroutine tests;seechapter14. TEMP VS Box ThetemperaturemeasurementisdisplayedasnumericinformationintheTEMPVSbox.Other data,includingtemperaturerelatedalarminformation,arealsoprovidedinthisareaofthe screen,asdetailedbelow. 1 2 3 6 5 4 Item Name Definition 1 Alarm flag area Displays TEMP alarm flags when detected; see page 4-31. 118MonitoringTemperature ExpressionMR400InstructionsforUse Item Name Definition 2 3 4 5 6 Temperature upper alarm limit Temperature lower alarm limit Temperature numeric Unit of measure TEMP VS box label Is the upper limit setting for the TEMP alarm, and accesses the TEMP Alarm Limits menu Is the lower limit setting for the TEMP alarm, and accesses the TEMP Alarm Limits menu Is the patients detected temperature measurement Indicates that the temperature numeric is given in degrees Celsius (C) or degrees Fahrenheit (F) Indicates the temperature vital sign parameter, and accesses the TEMP menu Changing the TEMP Alarm Limits TheTEMPAlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheTEMPVS box. 3 4 5 6 7 8 9 10 2 1 Alarm limit settings, TEMP VS box Enter button Current adjustment TEMP Alarm Limits menu label Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum 1 2 3 4 5 6 7 8 9 High button Low button 10 ExpressionMR400InstructionsforUse MonitoringTemperature119 Changing the Unit of Measure Tochangetheunitofmeasure Step 1 Action SelecttheTEMPVSbox. TheTEMPmenuappears.Currentsettingsaredisplayed. SelectUnits. TheUnitsmenuappears.Thecurrentsettingishighlighted. Selectthedesiredunitofmeasure:

2 3 C F Thesettingischanged. TEMP Menu TheTEMPmenuitemallowsyoutocontroltheunitofmeasurefortemperature. ToopentheTEMPmenu SelecttheTEMPVSbox. TEMP menu TEMP VS box 1110MonitoringTemperature ExpressionMR400InstructionsforUse ThefollowingTEMPmenuitemsareavailable:

1 Units Units 1 Selectstheunitofmeasureusedforpresentationofthetemperaturenumericdata. Thefollowingoptionsareavailable:

C(Default) F Toselecttheunitofmeasurefortemperature SeeChangingtheUnitofMeasureonpage1110. ExpressionMR400InstructionsforUse MonitoringTemperature1111 1112MonitoringTemperature ExpressionMR400InstructionsforUse CHAPTER 12 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. ThismonitorusestheoscillometricmethodformeasuringNIBP.Studiesshowthat,especiallyin criticalcases(arrhythmia,vasoconstriction,hypertension,shock),oscillometricdevicesaremore accurateandconsistentthandevicesusingothernoninvasivemeasuringtechniques. Inadultandpediatricmode,thebloodpressuremeasurementsdeterminedwiththisdevice complywiththeAmericanNationalStandardforElectronicorAutomatedSphygmomanometers

(IEC80601230:2011)inrelationtomeanerrorandstandarddeviation,whencomparedtointra arterialorauscultatorymeasurements(dependingontheconfiguration)inarepresentative patientpopulation.Fortheauscultatoryreference,thefifthKorotkoffsoundwasusedto determinethediastolicpressure. Inneonatalmode,thebloodpressuremeasurementsdeterminedwiththisdevicecomplywith theAmericanNationalStandardforElectronicorAutomatedSphygmomanometers(IEC806012 30:2011)inrelationtomeanerrorandstandarddeviation,whencomparedtointraarterial measurementsinarepresentativepatientpopulation.Neonatalbloodpressuremeasurements determinedwiththisdeviceareequivalenttothoseobtainedbyanintraarterialbloodpressure measurementdevice,withinthelimitsprescribedbytheAmericanNationalStandard,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. ExpressionMR400InstructionsforUseMonitoringNIBP121 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. Patient Preparation for NIBP Monitoring WARNINGS The NIBP cuff inflation rate may increase and the initial pressure may increase up to 180 mmHg when changing the patient type. Patient Category: Select the correct patient category setting for your patient. Do not apply the higher adult inflation, overpressure limits and measurement duration to neonatal patients as this may result in inaccurate readings or patient injury. ThePatientTypeshouldbeselected,asthissettingdeterminestheinflationpressuresofthe NIBPcuff,readingtimesandappropriatealarmlimitrange. Whenpositioningthepatient,routineNIBPmeasurements(includingforthecondition hypertension)requirethepatienttoremainsilent,stillandrelaxed,withlegsuncrossedandarms supported.NotethatduringMRIprocedures,patientsaretypicallylayingdownwiththeirlegs uncrossedandarmssupportedasneededfortheMRIscan,anda5minutewaitingperiodisalso recommendedbeforestartingreadings.Ensurethatthecuffisattheleveloftherightatriumof theheart. Insomecases,apatientmayexhibitalowpulseamplitudeduetoanyofthefollowing conditions.Thelistprovidesonlysomeexamplesofpotentialcausesoflowpulseamplitudesthat canmakeNIBPdifficulttomeasureinaconvenientandtimelymanner:

Sedation Diseaseorillness Physiologicalorneurologicalconditions Medication Obesity(oranyoccurrenceofmetabolismwithextremevariations) Stress Size 122MonitoringNIBPExpressionMR400InstructionsforUse 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 3-11) 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 1-36. 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. AwidevarietyofNIBPcuffsandinterconnecthosesareavailableforyourmonitoringneeds;see page136fordetails. TheNIBPcuffshouldbeselectedasitwouldbeforanauscultatorybloodpressure determination.ThecurrentguidelinesoftheAmericanHeartAssociationmustbefollowed. ExpressionMR400InstructionsforUseMonitoringNIBP123 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. Allpatientsthemiddleofthecuff shouldbeplacedattheleveloftheright atriumoftheheart. 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. 124MonitoringNIBPExpressionMR400InstructionsforUse 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. TheNIBPcuffshouldbepositionedasitwouldbeforanauscultatorybloodpressure determination.ThecurrentguidelinesoftheAmericanHeartAssociationmustbefollowed.Wrap theNIBPcufffirmly(notsnuggly)aroundthearmorlegofthepatient,makingsurethatthecuff isattheapproximatelevelofthehearttoensureaccuracyoftheobtainedvalues. 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 InserttheappropriateinterconnecthoseconnectorontotheNIBP port.Pushthehoseconnectorforwardandthenturnitclockwise. NIBP port ExpressionMR400InstructionsforUseMonitoringNIBP125 Step 2 Action AttachaNIBPcuffappropriateforthepatienttypeandsizetothe interconnecthose. 3 4 Positionthecuffonthepatient;seepage125. Ensurethatthecuffandinterconnecthosesarenotkinked. Choosing the Measurement Mode NIBPmeasurementscanbetakenautomaticallyormanually,usingthemodethatbestsuitsthe needsofyourpatient.ThefollowingarefrequentlyusedfunctionsrelatedtoNIBP;alsoreferto page1214forotherNIBPfunctions. Making Automatic Measurements Youcanautomaticallymeasureapatientsbloodpressureatpredefinedintervals,whichare measuredfromthestartofoneNIBPmeasurementtothestartofthenext. Toturnonautomaticoperation Step 1 Action SelectthePatientType. SeeSelectingthePatientTypeonpage311. PresstheNIBPIntervalkey. TheIntervalmenuappears.Thecurrentsettingishighlighted. Selectthedesiredminute(s)fortheinterval:

2 3 1Min 2Min 3Min 5Min 10Min 15Min 20Min 30Min Theselectionisentered. 126MonitoringNIBPExpressionMR400InstructionsforUse Step 4 5 Action SelecttheNIBPVSbox.OntheNIBPmenu,toggleAutoModeto On. Tobeginautomaticoperation,presstheNIBPStart/Stopkey. Making Manual Measurements Youcanmanuallydefinethemeasurementintervalofapatientsbloodpressure. Tocontrolmanualoperation Step 1 Action SelectthePatientType. SeeSelectingthePatientTypeonpage311. 2 Tostartorstopthemeasurement,presstheNIBPStart/Stopkey. Initial Inflation Pressures and Reading Durations WARNINGS Performing NIBP measurements too frequently 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 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. ExpressionMR400InstructionsforUseMonitoringNIBP127 Stopping an NIBP Measurement PresstheNIBPStart/Stopkeytostopareadingcycle. Suspend Mode during NIBP Measurements WhentheSuspendkeyispressed,NIBPfunctionswillbeaffectedasfollows:

Anyreadinginprogresswillbestopped. Thesystemwillpumptotheinitialinflationpressurefortheselectedpatienttype. Manualreadingscanbetaken. Autoreadingscannotbetaken. TheNEXTtimerwillnotrun. WhenexitingSuspendMode,anymanualreadingwillnotbestopped. NIBP VS Box TheNIBPmeasurementsaredisplayedasnumericinformationintheNIBPVSbox.Otherdata, includingNIBPrelatedalarminformation,arealsoprovidedinthisareaofthescreen,asdetailed below. Note Depending upon the selected Format (see page 12-17) of the data, the elements contained in the NIBP VS box are displayed in the Systolic/Diastolic format or in the Mean format. Systolic/Diastolic Format 1 2 3 12 11 10 9 8 567 4 128MonitoringNIBPExpressionMR400InstructionsforUse Item Name Definition Alarm flag area Displays NIBP alarm flags when detected; see page 4-31. Dia upper alarm limit Dia lower alarm limit Sys lower alarm limit Sys upper alarm limit Mean numeric Is the upper limit setting for the diastolic alarm, and accesses the NIBP Alarm Limits menu Is the lower limit setting for the diastolic alarm, and accesses the NIBP Alarm Limits menu Is the lower limit setting for the systolic alarm, and accesses the NIBP Alarm Limits menu Is the upper limit setting for the systolic alarm, and accesses the NIBP Alarm Limits menu Is the patients detected mean pressure measurement Diastolic numeric Is the patients detected diastolic pressure measurement Systolic numeric Is the patients detected systolic pressure measurement 1 2 3 4 5 6 7 8 9 Unit of measure 10 Elapsed time / cuff pressure Indicates that the NIBP measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals) Is the time since the last completed NIBP reading, 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. 11 Auto Mode setting 12 NIBP VS box label Indicates Manual when in manual mode; or, Next when in automatic mode along with 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 Indicates the NIBP vital sign parameter, and accesses the NIBP menu ExpressionMR400InstructionsforUseMonitoringNIBP129 Mean Format 1 2 3 10 89 7 6 5 4 Item Name Definition 1 2 3 4 5 6 7 8 Alarm flag area Displays NIBP alarm flags when detected; see page 4-31. Mean upper alarm limit Mean lower alarm limit Mean numeric Is the upper limit setting for the mean alarm, and accesses the NIBP Alarm Limits menu Is the lower limit setting for the mean alarm, and accesses the NIBP Alarm Limits menu Is the detected patients mean pressure measurement Diastolic numeric Is the patients diastolic pressure measurement Systolic numeric Is the patients systolic pressure measurement Unit of measure Elapsed time / cuff pressure Indicates that the NIBP measurement numeric values are given in mmHg

(millimeters of mercury) or kPa (kilopascals); see Pressure Units in the System Config menu on page 3-30. Is the time since the last completed NIBP reading, 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. 1210MonitoringNIBPExpressionMR400InstructionsforUse Item Name Definition 9 Auto Mode setting 10 NIBP VS box label Indicates Manual when in manual mode; or, Next when in automatic mode along with 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 Indicates the NIBP vital sign parameter, and accesses the NIBP menu Changing the NIBP Format TocontroltheformatoftheNIBPdata Step 1 Action SelecttheNIBPVSbox. TheNIBP1menuappears.Currentsettingsaredisplayed. SelectFormat. TheFormatmenuappears.Thecurrentsettingishighlighted. Selectthedesiredformat:

2 3 SysDia Mean Theformatischanged. Changing the Unit of Measure Note When using an 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 measurement numeric values to reflect the new unit of measure. Do not print or perform data captures during this period. ExpressionMR400InstructionsforUseMonitoringNIBP1211 Tochangetheunitofmeasure Step 1 Action PresstheSetupkeyandthentheMonitorkey. TheMonitorSetupmenuappears.Currentsettingsaredisplayed. OntheMonitorSetupmenu,selectService(BioMed). TheService(BioMed)menuappears. OntheService(BioMed)menu,selectSystemConfig. TheSystemConfigmenuappears.Currentsettingsaredisplayed. OntheSystemConfigmenu,selectPressureUnits. ThePressureUnitsmenuappears.Thecurrentsettingis highlighted. Selectthedesiredsetting:

2 3 4 5 mmHg kPa Thesettingisentered. Changing the NIBP Alarm Limits TheNIBPAlarmLimitsmenucanbeaccessedbytouchingthealarmlimitsettingsintheNIBPVS box. 3 4 5 6 7 8 2 9 10 11 12 1 Alarm limit settings, NIBP VS box Enter button Current adjustment 1 2 3 4 NIBP Systolic Alarm Limits menu label (active adjustment shown) 1212MonitoringNIBPExpressionMR400InstructionsforUse Alarm limit, minimum Lower alarm limit setting Upper alarm limit setting Alarm limit, maximum 5 6 7 8 9 High button Low button 10 11 NIBP Diastolic Alarm Limits menu label 12 NIBP Mean Alarm Limits menu label TochangetheNIBPalarmlimitsettings Step 1 Action SelectthealarmlimitsettingsintheNIBPVSbox. TheNIBPAlarmLimitsmenuappears.Currentsettingsare displayed. Selectthedesiredpressure:

NIBP(Sys) NIBP(Dia) NIBP(Mean) Thepressureisselected. SelecttheLowbuttonortheHighbutton. Theselectedbuttonwillbehighlightedandthecurrentadjustment willbedisplayed. Usingthekeypad,ortheincrement,decrement,orOffbuttons, enterthedesiredsetting. Thecurrentadjustmentwillreflectthechange. PresstheEnterbuttontosavethesetting. Thealarmlimitsettingisupdated. Tochangetheremainingsettings,repeatsteps2,3,4and5. Thecurrentadjustmentwillreflectthechange. 2 3 4 5 6 Note See chapter 4 for detailed alarm limit setting instructions and options. ExpressionMR400InstructionsforUseMonitoringNIBP1213 TheNIBPmenuallowsyoutocontrolnoninvasivebloodpressurefunctionsandsettings. ToopentheNIBPmenu SelecttheNIBPVSbox. NIBP Menu NIBP menu NIBP VS box ThefollowingNIBPmenuitemsareavailable:. Interval 1 2 Auto Mode 4 Format 1 2 3 TochangesettingsintheNIBPmenu Step 1 Action SelecttheNIBPVSbox. TheNIBPmenuappears.Currentsettingsaredisplayed. 1214MonitoringNIBPExpressionMR400InstructionsforUse Step 2 Action TouchthemenuitemtoselectoneofthefollowingNIBPoptions:

Interval AutoMode Format Themenuitemappears.Thecurrentsettingishighlighted. Selectthedesiredsettingfromthemenuoptions(exceptAuto Mode,whichisselectableontheNIBPmenu). Thesettingisentered. Tochangeothersettings,repeatsteps2and3. 3 4 Interval SetstheintervalforautomaticNIBPmeasurements. Thefollowingoptionsareavailable:

1Min 2Min 3Min(Default) 5Min 10Min 15Min 20Min 30Min TosettheintervalforNIBPreadings Step 1 Action SelecttheNIBPVSbox. TheNIBPmenuappears.Currentsettingsaredisplayed. ExpressionMR400InstructionsforUseMonitoringNIBP1215 Step 2 Action SelectInterval. TheIntervalmenuappears.Thecurrentsettingishighlighted. Selectthedesiredminute(s)fortheinterval:

3 1Min 2Min 3Min 5Min 10Min 15Min 20Min 30Min Thesettingischanged. Auto Mode SetsthemodeusedtotakeNIBPreadings. Note A manual reading will not restart this cycle time. Thefollowingoptionsareavailable:

Offtakesreadingsmanually(Manualmode),wherereadingsareinitiatedbypressingthe NIBPStart/Stopkey;seeMakingManualMeasurementsonpage127fordetails.(Default) Ontakesreadingsautomatically,wherewhenselected(orsinceleavingsuspendmode), thefirstreadingmustbeinitiatedbypressingtheNIBPStart/Stopkeyandthenall subsequentreadingswillbetakenattheselectedinterval;seeMakingAutomatic Measurementsonpage126forothersetupdetails. TosetthemodeforNIBPreadings Step 1 Action SelecttheNIBPVSbox. TheNIBPmenuappears.Currentsettingsaredisplayed. LocateAutoModeandselectthedesiredsetting:

2 Off On Thesettingisentered. 1216MonitoringNIBPExpressionMR400InstructionsforUse Format SetsthedisplayedformatoftheNIBPnumericdata. Thefollowingoptionsareavailable:

SysDiadisplaysthesystolicanddiastolicnumericsinalargefontseparatedbyaslashand themeannumericwillbeinasmallerfontbracketedwithparenthesis.(Default) Meandisplaysthemeanmeasurementnumericinalargefont,andthesystolicand diastolicmeasurementnumericvaluesinasmallerfontandseparatedbyaslash. TocontroltheformatoftheNIBPdata SeeChangingtheNIBPFormatonpage1211. ExpressionMR400InstructionsforUseMonitoringNIBP1217 1218MonitoringNIBPExpressionMR400InstructionsforUse CHAPTER 13 Trend Data and Printing Trending Functions TheMR400providesversatiletrendingfeatures,includingtrendarrowindicationsformonitored parametersandtabulartrendsreporting.TheMR400storesupto12hoursofhistoricaltrend data,retaininginformationwhennewpatientsareconnectedtothehostandthroughshort powercycles;however,ifpowerisremovedfor10minutesorlonger,allstoredtrenddatawillbe lost. Viewing Tabular Trend Data Toviewtabulartrenddataforanyavailableparameter Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Allowthetrendsdatato 2 3 refresh. Selectthecorrespondingbutton(s)oftheparameter(s)thatyou wanttoexamine. Usethenavigationbuttons(seepage132)tomovethroughthe datapages. Tabular Trends Menu TheTabularTrendsmenuallowsyoutocontroltrendfunctions,todisplaytrendedpatientdata, andtoprintdatawhenconnectedtoanIP5andprinter. ToopentheTabularTrendsmenu PresstheTrendskey. ExpressionMR400InstructionsforUse TrendDataandPrinting131 Notes Refreshing Trend Data may be displayed while the information on the page is being populated. In the illustration below, the trend buttons for all parameters are shown in their selected state. 18 1 2 17 16 3 4 15 14 13 12 11 10 6789 5 Item Name Definition 1 2 Page Indicates the current page and the total page count of the file Navigation buttons Allows you to move through the listings as follows:

Moves one column to the left Moves to the first (oldest) file page Moves up one file page Moves down one file page Moves to the last (most recent) file page Moves one column to the right 132TrendDataandPrinting ExpressionMR400InstructionsforUse Item Name Definition 3 4 5 6 7 8 9 10 11 12 13 Parameter headings Trends key Identifies the parameter reading for the associated column of data

(in the same color as that of the vital sign) Opens the Tabular Trends menu Agents trend button Displays the AGENT parameter readings, where percentages for primary and secondary end-tidal (Et) and fractional inspired (Fi) gases (ID) are provided in the form: Et ID% Fi ID%

Displays the N2O parameter readings N2O trend button O2 trend button Displays the O2 parameter readings TEMP trend button Displays the temperature parameter readings (and the unit of RESP (CO2) trend button ETCO2 trend button SPO2 trend button measure) Displays the CO2-derived respiration parameter readings (and source) Displays the end-tidal CO2 parameter readings (and the unit of measure) Displays the SPO2 parameter readings P2 trend button Displays the P2 parameter readings (and the unit of measure) P1 trend button Displays the P1 parameter readings (and the unit of measure) 14 HR trend button Displays the heart rate parameter readings (and source) 15 NIBP trend button 16 Refresh Trends button Displays the NIBP parameter readings (and the unit of measure), given in the form: Systolic/Diastolic (Mean) Refreshes the readings Note While Refreshing Trend Data, the screen will freeze momentarily;

however, audible alarms will continue to function. 17 Tabular Trends menu 18 Date Is the Tabular Trends menu (see below for details) Is the date (and time) of the readings ExpressionMR400InstructionsforUse TrendDataandPrinting133 ThefollowingTabularTrendsmenuitemsareavailable:. 1 Trend Arrows 2 Arrow Period 3 Data Interval 4 Clear Trends 5 Print Page 6 Print All 7 Stop Print 1 2 3 4 5 6 7 TochangesettingsandcontrolfunctionsintheTabularTrendsmenu Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. Selectfromthefollowingmenuitems:

TrendArrows ArrowPeriod DataInterval ClearTrends PrintPage PrintAll StopPrint Formenuiteminformation,seetheappropriatesectionbelow. Selectfromthedesiredsettingofmenuoptions(exceptTrend Arrows,whichisselectableontheTabularTrendsmenu.) Thesettingisentered. Tochangeothersettings,repeatsteps2and3. 2 3 4 Trend Arrows Controlsvitalsigntrendindications,wheretrendarrowsaredisplayedalongsidetheVSboxes

(exceptforNIBPandbellowsderivedrespiration),withameaningasdefinedbelow. 134TrendDataandPrinting ExpressionMR400InstructionsforUse WARNING Depending upon the Arrow Period menu option and measurement cycles of the vital signs, NIBP trend arrow indications may not be representative of the current condition of the patient. 1 1 Trend arrow indications, where is rising is declining is stable is none declared Thefollowingoptionsareavailable:

Offturnsoffthetrendarrows.(Default) Onturnsonthetrendarrows. ExpressionMR400InstructionsforUse TrendDataandPrinting135 Tocontroltrendarrowindications Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. 2 3 OntheTabularTrendsmenu,selectTrendArrows. TheTrendArrowsmenuappears.Thecurrentsettingishighlighted. Selectthedesiredsetting:

Off On Thesettingischanged,andthedisplayischangedaccordingly. Arrow Period Controlsthetimethatmustelapsebeforeatrendarrowchangecanoccur. Thefollowingoptionsareavailable:

30Seconds 1Minute 3Minutes(Default) 5Minutes 10Minutes Tocontrolthetrendarrowperiod Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. 2 OntheTabularTrendsmenu,selectArrowPeriod. TheArrowPeriodmenuappears.Thecurrentsettingishighlighted. 136TrendDataandPrinting ExpressionMR400InstructionsforUse Step 3 Action Selectthedesiredsetting:

30Seconds 1Minute 3Minutes 5Minutes 10Minutes Thesettingischanged. 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. However, if the newly selected period is longer than the previous period, recalculation will occur using all available data. Data Interval Controlsthetimethatmustelapsebeforetrenddatareadingsaretaken. Thefollowingoptionsareavailable:

1Minute 5Minutes(Default) 10Minutes 15Minutes 20Minutes 25Minutes 30Minutes 45Minutes 60Minutes AutoNIBP(OccursattheIntervalselectedforautomaticNIBPmeasurements;seepage 1215fordetails) ExpressionMR400InstructionsforUse TrendDataandPrinting137 Tocontrolthedatainterval Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. 2 3 OntheTabularTrendsmenu,selectDataInterval. TheDataIntervalmenuappears.Thecurrentsettingishighlighted. Selectthedesiredsetting:

1Minute 5Minutes 10Minutes 15Minutes 20Minutes 25Minutes 30Minutes 45Minutes 60Minutes AutoNIBP Thesettingischanged. Clear Trends Removesalltrenddata,usefultoensurethatthemonitoredinformationreflectsdataforonlyone patient. Toclearalltrenddata Step 1 Action PresstheClearTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. 2 3 OntheTabularTrendsmenu,selectClearTrends. TheClearTrendsmenuappears. Followallassociateddialogstoclearthefile.Thedataiserased. 138TrendDataandPrinting ExpressionMR400InstructionsforUse Print Page PrintsthecurrentlydisplayedTrendspagewhenconnectedtoaprinterequippedIP5. Toprintthepage Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. 2 OntheTabularTrendsmenu,selectPrintPage. Print All PrintsallTrendspageswhenconnectedtoaprinterequippedIP5. Toprinttheallpages Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. 2 OntheTabularTrendsmenu,selectPrintAll. Stop Print Stopsprintingofthetrendspage(s)whenconnectedtoaprinterequippedIP5. Tostopacurrentprintjob Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Currentsettingsaredisplayed. 2 OntheTabularTrendsmenu,selectStopPrint. ExpressionMR400InstructionsforUse TrendDataandPrinting139 Printing Functions WhenequippedwithanIP5andprinter,theMR400canproducehardcopiesofuptotwo waveforms,trendinformationandpatientdatareports. Notes If a printer-equipped IP5 is not installed or connected, an indication is displayed on the Print key; see page 13-11. Any print command from the MR400 automatically initiates a 30-second print cycle at the IP5. Any print command initiated from the MR400 takes precedence over the IP5 print functions. Printing Parameter-Specific Trends Trendedinformationcanbeprintedseparatelyforeveryparameter(exceptbellowsderived respiration). Toprintindividualtrenddata Step 1 Action PresstheTrendskey. TheTabularTrendsmenuappears.Allowthetrendsdatato refresh. Selectthetrendbuttonoftheparameterthatyouwanttoprint. Thecorrespondingvitalsigndataappears.Thecurrentpageis displayed. SelectPrintAlltoprintallthedatafortheparameter,orselect PrintPagetoprintthecurrentlydisplayeddata. 2 3 ThedataisprintedattheIP5. Controlling Printer Outputs Tostartandstoptheprintingofastripchart,pressthePrintkey. Iftheprinterisallowedtorunafterprinting,paperwillcontinuetobeoutputforabout30 secondsbeforeautomaticallystopping. 1310TrendDataandPrinting ExpressionMR400InstructionsforUse Printer Indications ThesymboldisplayedonthePrintkeyindicatesthestateoftheremoteprinter,asshowninthe tablebelow. Symbol Indication Theprinterisready. Printingisinprocessandsecondsremain(25,intheexample)until completion. Noprinterisavailable. Thereisaprintererrorcondition. Printer Menu ThePrintermenuallowsyoutoconfiguretheMR400forprintingwhenanoptionalIP5and printerareconnected. ToopenthePrintermenu PresstheSetupkeyandthenthePrinterkey. ToopenthePrintermenu PresstheSetupkeyandthenthePrinterkey. ExpressionMR400InstructionsforUse TrendDataandPrinting1311

. Printer menu Setup key Printer key ThefollowingPrintermenuitemsareavailable:

1 Trace 1 2 Trace 2 3 Trace Delay 1 2 3 TochangesettingsinthePrintermenu Step 1 Action PresstheSetupkeyandthenthePrinterkey. 2 3 ThePrintermenuappears.Currentsettingsaredisplayed. Selectfromthefollowingmenuitems:

Trace1 Trace2 TraceDelay Theselectedmenuappears.Currentsettingsaredisplayed.(For menuiteminformation,seetheappropriatesectionbelow.) Selectthedesiredmenuitem. Thecurrentsettingishighlighted. 1312TrendDataandPrinting ExpressionMR400InstructionsforUse Step 4 Action Selectthedesiredsettingfromthemenuoptions. Thesettingisentered. Tochangeothersettings,repeatsteps2,3and4. 5 Trace 1 PrintsaselectedparameterswaveformintheTrace1waveformlocationonastripchart,as shownintheillustrationbelow.(Astripcancontaintwowaveforms.) Note If Trace 2 is off, then Trace 1 is printed using the full 40 mm width of the strip. 1 2 3 4 5 6 7 11 10 9 8 1 Trace 1 setting 2 Date and time (formatted as MM/DD/YY-HH:MM:SS) 3 Patient type 4 Trace delay 5 Trace speed 6 Parameter setting information 7 Values of active parameters at time of printing 8 Trace 2 parameter information 9 Trace 2 setting 10 Trace 2 waveform 11 Trace 1 waveform Thefollowingoptionsareavailable:

ECG1outputstheTraceAwaveform(Default) ExpressionMR400InstructionsforUse TrendDataandPrinting1313 ECG2outputstheTraceBwaveform SPO2outputstheTraceCwaveform RESP(CO2)outputstheTraceDwaveform P1outputstheTraceEwaveform P2outputstheTraceFwaveform ToprintawaveformintheTrace1location Step 1 Action PresstheSetupkeyandthenthePrinterkey. ThePrintermenuappears.Currentsettingsaredisplayed. SelectTrace1. TheTrace1menuappears.Thecurrentsettingisdisplayed. Selectthedesiredsettingfromthemenuoptions:

2 3 ECG1 ECG2 SPO2 RESP(CO2) P1 P2 Thesettingisentered. Trace 2 PrintsawaveformintheTrace2locationonastripchart(seeexample,onpage1313). Note When printing two traces, the waveform to grid ratio will not correspond to the displayed waveform/scale indicator size. Thefollowingoptionsareavailable:

Off(Default) ECG1outputstheTraceAwaveform. ECG2outputstheTraceBwaveform. SPO2outputstheTraceCwaveform. P1outputstheTraceEwaveform. 1314TrendDataandPrinting ExpressionMR400InstructionsforUse P2outputstheTraceFwaveform. RESP(CO2)outputstheTraceDwaveform. ToprintawaveformintheTrace2location Step 1 Action PresstheSetupkeyandthenthePrinterkey. ThePrintermenuappears.Currentsettingsaredisplayed. SelectTrace2. TheTrace2menuappears.Thecurrentsettingisdisplayed. Selectthedesiredsettingfromthemenuoptions:

2 3 Off ECG1 ECG2 SPO2 P1 P2 RESP(CO2) Thesettingisentered. Trace Delay Allowsyoutodelaythetimewhensendingthetracedatatotheprinter. Thefollowingoptions(inseconds)areavailable:

0S 4S(Default) 8S 16S Tosetaprintingtimedelay Step 1 Action PresstheSetupkeyandthenthePrinterkey. ThePrintermenuappears.Currentsettingsaredisplayed. SelectTraceDelay. 2 TheTraceDelaymenuappears.Thecurrentsettingisdisplayed. ExpressionMR400InstructionsforUse TrendDataandPrinting1315 Step 3 Action Selectthedesiredsettingfromthemenuoptions:

0S 4S 8S 16S Thesettingisentered. 1316TrendDataandPrinting ExpressionMR400InstructionsforUse Maintenance and Troubleshooting CHAPTER 14 WARNINGS Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. To reduce the possibility of damage to the equipment or injury to patients/personnel, perform all cleaning, disinfection, maintenance, software update, testing, disassembly and repair outside of the MR system room. Contact: If you discover a problem with any of the equipment, contact technical support or authorized service personnel. General Cleaning Guidelines KeeptheMR400andaccessoriesfreeofdust,dirtandpathogens.Aftercleaninganddisinfection, alwayschecktheequipmentcarefully.Stopusingequipmentthatshowssignsofdeteriorationor damage.Observethefollowinggeneralprecautionswhencleaning:

Alwaysdilutethecleaningsubstanceaccordingtothemanufacturersinstructionsoruse lowestpossibleconcentration. Neverallowliquidtoentertheequipment. Neverimmerseanypartoftheequipmentinliquid. Neverpourliquidontotheequipment. Neveruseabrasivematerialtowipetheequipment. Note For answers to questions regarding infection control, call us at (877) 468-4861 (inside the USA) or

+31 (0) 499 378299 (outside the USA). Cleanusingalintfreecloth,moistenedwithwarmwater(40C/104Fmaximum)andmildsoap, adilutednoncausticdetergentoralcoholbasedcleaningagent.Neverusestrongsolventssuch asacetoneortrichloroethylene.Stainscanberemovedbyscrubbingbrisklywithamoistened cloth.Ifdisinfectionisrequired,cleantheequipmentbeforedisinfectingit. Whencleaningthetouchscreen,wipeitgentlyusingasoftnonwovenclothwith80%diluted alcoholmixture. ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting141 UseonlytheRoyalPhilipsapprovedsubstancesandmethodslistedinthischaptertocleanor disinfecttheequipment.RoyalPhilipsmakesnoclaimsregardingtheefficacyofthelisted chemicalsormethodsasameansforcontrollinginfection.Warrantydoesnotcoverdamage causedbyusingunapprovedsubstancesormethods. Therecommendedtypesofdisinfectingagentsarelistedinthetablebelow.Wemakenoclaims regardingtheefficacyofthelistedchemicalsormethodsasameansforcontrollinginfection. Consultyourfacility'sInfectionControlOfficerorEpidemiologist.Forcomprehensivedetailson cleaningagentsandtheirefficacyrefertoGuidelinesforPreventionofTransmissionofHuman ImmunodeficiencyVirusandHepatitisBVirustoHealthCareandPublicSafetyWorkersissuedby theU.S.DepartmentofHealthandHumanServices,PublicHealthService,CentersforDisease Control,February1989.Alsorefertoanypoliciesthatapplywithinyourfacilityandcountry. Product Name Cavicide Disinfectant: CaviWipes Coverage Disinfectant: Coverage Spray TB, TB Plus, HB Plus* Spray Sani-Cloth Germicidal Wipes*

Sklar Disinfectant*

*Anyproductresidueshouldberemovedbywipingthesurface. Product Type Towelette Towelette Towelette, spray Removing all Power to the MR400 Inordertoclean,disinfect,inspect,testorservicetheMR400,itmaybenecessarytoremove powertothecart. ToremoveallpowertotheMR400cart Step 1 2 Action Pressthenholdthepowerswitchforapproximately2secondsto turnoffpowertothecart. PulltheplugofpowercordfromtheACwalloutlet.Then,liftthe strainreliefandremovethepowercordfromtheACreceptacleon thecart.Disconnectanygatingconnectionfromthecart;

otherwise,removetheshieldcap. 142MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Step 3 Action Pressthebatteryejectbuttontopartiallyejectamaincartbattery fromabatterycompartment,andthengraspthebatteryandpull toremoveitcompletelyfromtheMR400. Battery compartment Battery eject button Main cart battery

(Ifthebatterydoesnotrelease,applyaslightforwardpressureto thebatterywhilepressingthebatteryejectbutton.) Repeatsteps1and2toremovetheothermaincartbatteryonthe oppositesideoftheMR400. Removethetwoscrewsthatsecuretheservicepanelcovertothe MR400andthenremovetheservicepanelcover. 4 5 Screws Service panel cover ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting143 Step 6 Action LocatethebatteryswitchandtoggleitintotheOff(O)position. Battery switch Restoring all Power to the MR400 TorestoreallpowertotheMR400,seepage116. Removing Power from the Wireless Modules Inordertoclean,disinfectorinspectawirelessmoduleitmaybenecessarytoremovepower fromthedevice.Toturnpowerofftothewirelessmodules,proceedaccordingtothemodule type:

wECGmodule:Removeallinstalledbatteries(seepage125). wSpO2module:Removethebattery(seepage127). Restoring Power to the Wireless Modules Torestoreallpowertothewirelessmodules,proceedaccordingtothemoduletype:

wECGmodule:Installatleastonebattery(seepage124). wSpO2module:Installonebattery(seepage126). User Routine-Checks and Planned Maintenance Thisproductrequiresroutinechecking,plannedmaintenanceandtestingthatmustperformed onascheduledbasistokeeptheproductoperatingsafely,effectivelyandreliably. UserRoutineChecksProgram 144MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Theuseroftheproductmustinstitutearoutinechecksprogramasdetailedinthetablebelow. Theuseroftheproductshallmakesurethatallchecksandactionshavebeensatisfactorily completedbeforeusingtheproductforitsintendedpurpose. Area / Item Frequency Required Action Accessories Alarms Daily Daily Module batteries Every 8 hours of use Wireless module If dropped Clean and inspect for damage; see page 14-7. Confirm proper function; see Testing Alarms on page 14-11. Recharge; see page 2-16 for displayed indications, and refer to the battery chargers IFU for recharging instructions. Inspect and clean (see page 14-9) then test (see page 14-12). PlannedTestingProgram Plannedmaintenancemayonlybecarriedoutbyqualifiedandauthorizedpersonnel,andis comprehensivelydescribedintheservicedocumentation.Philipsprovidesafullplanned maintenanceandrepairserviceonbothacallbasisandacontractbasis.Fulldetailsareavailable fromyourPhilipsServiceOrganization.Asummaryofserviceeventsandmaintenance requirementsappearsinthetablebelow. Area / Item Frequency Required Action Monitor cleaning Every 6 months Perform external cleaning Perform calibration. Perform calibration. Perform calibration. Perform Visual Inspection, and Power On, Verification and Safety Tests System -

AGENT option System - CO2

(LoFlo option) System- NIBP System Once per year or as specified by local laws Once per year or as specified by local laws Once per year or as specified by local laws Once per year or as specified by local laws, or after any type of repair or service event ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting145 Area / Item Frequency Required Action Cart batteries:

two main and two reserve Module batteries Every 12 months Every 12 months Replace the main batteries; see page 1-16. Replace the reserve batteries; contact technical support. Replace the module batteries; see page 1-23. Cleaning, Disinfection, and Damage Inspection Cleaninganddisinfectionofthisproductisrequiredperiodically.Generalguidelinesforeachare givenbelow. WARNING Always isolate the product from the mains electrical supply and remove and disconnect batteries before cleaning, disinfecting or sterilizing to prevent electric shocks. CAUTION Never allow water or other liquids to enter the product, since these may cause electrical short-

circuits or metal corrosion. Cleaninganddisinfectiontechniquesforboththeproductandtheroommustcomplywithall applicablelocallawsandregulations. Cleaning Enameledpartsandaluminumsurfacesshouldonlybewipedcleanwithadampclothandamild detergent,andthenrubbeddownwithadrywoolencloth.Neverusecorrosivecleaningagents, solvents,abrasivedetergentsorabrasivepolishes.Ifyouarenotsureaboutthepropertiesofa cleaningagent,donotuseit. Disinfection Thosepartsoftheproductthataresuitableforsuchtreatment,includingaccessoriesand connectingcables,canbedisinfectedbygentlywipingthesurfaceswithaclothdampenedwitha suitableagentforabriefperiod(30secondsto1minute)orasdirectedbythesubstance manufacturer.Neverusecorrosiveorsolventdisinfectantsorsterilizingagents.Ifyouarenot sureaboutthepropertiesofadisinfectantorsterilizingagent,donotuseit. 146MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse WARNING Do not use flammable or potentially explosive disinfecting sprays. Such sprays create vapors, which can ignite, causing fatal or other serious personal injury. CAUTION Disinfecting a medical product room by means of sprays is not recommended, since the vapor could penetrate the product, causing electrical short-circuits, metal corrosion or other damage to the product. Cleaning, Disinfecting, and Inspecting the Accessories Anyreusablepatientaccessory(suchasECGcables,SPO2attachmentsandprobes,temperature sensors,etcetera)mustbecleanedanddisinfectedbeforeinitialuseandaftereachuseto protectpatientsandpersonnelfromavarietyofpathogens.Usesoapandwater,andasuggested disinfectantandmethod,tocleananddisinfecttheaccessories.Thewarrantydoesnotcover damagecausedbyunapprovedsubstancesormethods. Duringthecleaningprocess,inspecttheaccessoryfordamage.Theaccessoriesareexposedto potentiallydamagingsituationsduringuseandcleaning.Beforeeachuse,carefullyinspectthe accessoriesforthefollowingsignsofdamage:

Cracks,holes,tears,gouges,cuts,etcetera. Cracksorothersignsofdamagetotheconnector,includingbentordamagedpins. Disposableaccessoriesmustbediscardedandreplacedwithnewitems. 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. 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. ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting147 Tocleanareusableaccessory Step 1 2 Action Removetheaccessoryfromuse. Removeallvisibledebrisfromtheaccessoryusingsoapandwater. CAUTION Never pour liquid onto the accessory. 3 4 CleantheaccessorybythoroughlywipingitusingCaviWipes disinfectanttowelettes.Discardtheusedtowelettes(refertoyour facility'sbiohazardprocedurefordisposal). Note Follow the Instructions for Use from the disinfectant manufacturer to clean the probe. DisinfecttheaccessorybythoroughlywettingitusingCaviWipes disinfectanttowelettes.Discardtheusedtowelettes(refertoyour facility'sbiohazardprocedurefordisposal). Note Follow the Instructions for Use from the disinfectant manufacturer to disinfect the probe. 5 Allowtheaccessorytodry.(Norinsingisrequired.) Checktheaccessoryforanyresidualdebris.Ifanydebrisispresent, repeatsteps2through5thenreexaminetheitembefore proceeding. Note Disposable SPO2 attachments: After some use, adhesive residue may accumulate at the fiber heads on the probe. Carefully remove any residue with alcohol to keep the glass fiber ends clean. Checktheaccessoryfordamage(cracks,holes,tears,cuts,et cetera)anddiscardtheaccessoryifdamageisfound. Storetheaccessory;seepage212fordetails. 6 7 8 148MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Cleaning, Disinfecting, and Inspecting MR400 and Wireless Modules FollowthegeneralguidelinestocleantheMR400cartandthewECGandwSpO2modules. Alwaysturnoffthecartandthewirelessmodulestoperformcleaning.Neverimmerseany portionofthecartorwirelessmodulesinfluidorattempttocleanthedevicesbydirectly applyingliquidcleaningagents. Duringthecleaningprocess,inspecttheMR400andthewirelessmodulesfordamaged,looseor missinghardware;iffound,takecorrectiveactionorcontacttechnicalsupport. WARNING Always disconnect the MR400 from AC mains 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 MR400 in any cleaning agent or attempt to clean it with liquid cleaning agents. CAUTIONS Other than those specified in the preceding table, avoid ammonia-, phenol- and acetone-

based cleaners as they will damage the surfaces of the MR400. Disinfect the MR400 cart and wireless 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 touch screen. Contact technical support if liquid enters any component. If the MR400 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 Action TurnofftheMR400anddisconnectallpower;seepage142. Removethebatteryfromeachwirelessmodule;seepage144. Cleanthetouchscreenbywipingitgentlyusingasoftnonwoven clothwith80%dilutedalcoholmixture. Removeallvisibledebrisfromthecartandwirelessmodulesusing soapandwater. CAUTIONS Never pour liquid onto the equipment. ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting149 Step 5 Action Cleanthecartandmodulesbythoroughlywipingthedevicesusing CaviWipesdisinfectanttowelettes.Discardtheusedtowelettes

(refertoyourfacility'sbiohazardprocedurefordisposal). Note Follow the Instructions for Use from the disinfectant manufacturer to clean the cart and wireless modules. 6 7 8 9 Disinfectthecartandmodulesbythoroughlywettingthedevices usingCaviWipesdisinfectanttowelettes.Discardtheused towelettes(refertoyourfacility'sbiohazardprocedurefor disposal). Note Follow the Instructions for Use from the disinfectant manufacturer to disinfect the cart and wireless modules. Allowthecartandthewirelessmodulestodry.(Norinsingis required.) Checkthecartandthewirelessmodulesforanyresidualdebris.If anydebrisispresent,repeatsteps3through6thenreexaminethe cartandwirelessmodulesbeforeproceeding. Checkthecartandwirelessmodulesfordamaged,looseormissing hardware.Contacttechnicalsupportifnecessary. 10 Storethemodule;seepage212fordetails. Sterilization TheMR400cart,wirelessmodulesandaccessoriesarenotsterilizable;donotimmerseanypartof theseitemsinfluidorattempttocleanthemwithunspecifiedliquidcleaningagents.Severe damage,notcoveredbythewarranty,willresult. 1410MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Testing Alarms Note If a problem with the alarm sound or messaging system is suspected, discontinue use of the MR400 and immediately refer it to authorized service personnel for evaluation. Toverifythealarmfunctions Step 1 Action WiththeMR400turnedonandnotinsuspendmode,ensurethat AlarmSoundisturnedonintheAlarmsmenu. 2 3 4 5 6 7 MakesurethattheloweralarmlimitforSPO2isnotoff. CheckthebatteryindicatoronthewSpO2moduletoensurethat enoughchargeexists:

Greenbatteryindicator=Chargesufficient;proceedtostep5. Redbatteryindicator=Chargelow;proceedtostep4. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) InsertachargedmodulebatteryintothewSpO2moduleandthen recheckthebatteryindicatortoensureasufficientchargebefore proceeding;seepage126. CheckthenetworkchannelindicatoronthewSpO2moduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep7. Flashing=Nocommunication;proceedtostep6. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) EnsurethatthewSpO2moduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129. PlacetheSPO2attachmentonyourfingerandwaitforavalueto appearintheSPO2VSbox. ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting1411 Step 8 Action Removeyourfingerfromtheattachment. 9 Verifythefollowing:

NonPulsatorProbeOffappearsintheSPO2alarmflagarea, TheSPO2waveformflatlines. Thenumericflashesinyellow;and, Thealarmtonesounds. Thiscompletesthetestofthealarmsystem. Testing a Dropped Wireless Module IntheeventthatthewECGorwSpO2modulehasbeendropped,itisimportanttodeterminethe functionalityofthedevicebeforeattemptingtomonitorapatient. Toverifythebasicfunctionsofadroppedwirelessmodule Step 1 Action Performavisualexaminationthedroppedmoduleforsignsof breakage(crackedhousings,damagedconnectors,etcetera):

2 3 4 Ifnosignsofdamagearepresent,gotostep2;or, Ifnoticeabledamageispresent,gotostep6. Ensurethatafreshmodulebatteryisinstalled.(Ifcheckingthe wECGmodule,ensurethattwofreshbatteriesareinstalled.)Then, checkthemoduleandproceedaccordingly:

Ifthebatteryindicator(s)andnetworkchannelindicatorare illuminated,gotostep3;or, Ifthebatteryindicator(s)andnetworkchannelindicatorare NOTilluminated,gotostep6. Ensurethatthemoduleiswithin9.1m(30feet)oftheMR400,in thesameMRIroomorinthesameshieldedroom,andissettothe samewirelessnetworkchannelusedbytheMR400;seepage129. Checkthestatusinformationpane(seepage216)ontheMR400 andproceedaccordingly:

Ifthebatterytimeremainingindicationandcommunication statusarepresentforthedroppedmodule,gotostep5;or, IfaredXispresent(orifblank)forthedroppedmodule,go tostep6. 1412MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Step 5 6 Action Thiscompletesbasicfunctionaltestingofthedroppedmodule. However,ifduringfurtherusage,problemsareencountered,such asstatusmessages(LeadFail,NoProbe,etcetera)then discontinueuseofthemoduleandreplaceitbeforeusingthe MR400system. Discontinueuseofthemoduleandreplaceitbeforeusingthe MR400system. Verification Testing VerificationtestingfortheMR400caninsomecasesbeperformedbytheuser,providedthe necessaryaccessoriesandtestequipmentareavailable.However,manyverificationtestsrequire specializedequipmentandtraining,andasaresultmustbeperformedbyqualifiedservice personnel;refertotheservicemanual(REF989803181911)foracomprehensivetesting procedureandcontacttechnicalsupportwithanyquestions. Anesthetic Oxygen (O2) Sensor Depletion Theanestheticoxygen(O2)sensorusesgalvanictechnologyandhasalimitedshelflife,as indicatedbytheexpirationdateprintedonthepackagingandsensor.Takenotethisexpiration dateandplanaccordinglyforreplacementschedulingoftheO2sensor;seepage1413for instructions. IftheO2sensorismissingormalfunctioning,AgentHWFailO2Sensorwillbedisplayedshortly afteractivationoftheAGENTparameter;or,duringCO2use,TurnOffCO2,ReplaceO2Sensor willbedisplayed.Ineachcase,theO2sensormustbereplacedbeforeAgentandgasmonitoring canproceed. Replacing the O2 Sensor TheO2sensorislocatedbehindtheservicepanelcoveratthebackoftheWPU. WARNING The gas sampling line must not be connected to the patient airway adapter or any other gas source during oxygen sensor replacement, as it will cause an incorrect calibration of the O2 reading. ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting1413 ToreplacetheO2sensor. Step 1 2 3 Action TurnofftheMR400. Ensurethatanygassamplinglinehasbeendisconnectedfromthe watertraponthepatientconnectionpanel. Removethetwoscrewsthatsecuretheservicepanelcovertothe backoftheWPUandthenremovetheservicepanelcover. Screws Service panel cover 4 LocatethesensortoolandtheO2sensorport. O2 sensor O2 tool 5 PlacethesensortoolintotheslotintheO2sensor,thenturnthe sensorcounterclockwiseuntilitdisengagesfromthesensorport. Slot 1414MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Step 6 Action InsertanewO2sensorintothesensorportandthen,usingthe sensortool,turnthesensorclockwiseuntilsecure. Sensor port O2 sensor 7 8 9 10 11 Replacetheservicepanelcoverandsecureitusingthetwoscrews. Connectagassamplinglinetothewatertrap. TurnontheMR400. TurnontheAgentsparameterandallowthesystemtorununtil CO2WarmingUpisnolongerdisplayed. CalibratetheO2sensorbyperformingthefollowingsteps:

a. PresstheMonitorkey. b. OntheMonitorSetupmenu,selectService(BioMed). c. OntheService(BioMed)menu,selectGasCal. d. OntheGasCalmenu,selectO2Cal. e. Whenprompted:FlowRoomAirfor10Seconds,Doyou wishtocontinue?SelectYestoproceed. ReadjustingCO2Zerowillbedisplayeduntilcalibrationis complete. Updating Software Asrevisionstothesoftwarebecomeavailable,theMR400canbeupdated;refertotheservice manual(REF989803181911).Itisrecommendedthatyoubackupyoursettingspriortoupdating software,sothattheycanberestoredafterward;seeEditUserSettingsonpage315. ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting1415 WARNING When performing software updates (or upgrades) to the operating software of the MR400, 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, et cetera. Calibrating the Touch Screen Note Touch screen calibration is not routinely required, but will occur after installation of new operating software. Tocalibratethetouchscreenmenu,refertotheservicemanual(REF989803181911). Troubleshooting Methodsfortroubleshootingproblemswhentheequipmentseemstobefunctioningincorrectly includeusingdisplayedalarmmessagesasastartingpoint;seechapter4foralisting. Plannedmaintenanceanduserroutinetestingarealsohelpfulwaystoconfirmdeviceoperations ortohelpidentifyaproblem;seepage144. TroubleshootingtheMR400iscomprehensivelydescribedintheservicedocumentation.Philips providesafullplannedmaintenanceandrepairserviceonbothacallbasisandacontractbasis. FulldetailsareavailablefromyourPhilipsServiceOrganization. Repair TheMR400containsnouserserviceableparts.Allrepairsmustbeperformedbytrainedservice personnel.Allrepairsonproductsunderwarrantymustbeperformedbyauthorizedpersonnel orinanauthorizedServiceandRepairCenter.Unauthorizedrepairswillvoidthewarranty. Circuitdiagrams,componentpartlists,descriptions,calibrationinstructions,andother informationtoassistservicepersonnelintherepairoftheserviceablepartsofthedeviceare availableintheservicemanual(REF989803181911)andonrequest. 1416MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse WARNINGS A shock hazard exists if the MR400 is operated without covers. Do not modify the MR400 Patient Monitoring System without authorization of the Invivo (Royal Philips). IftheMR400failstofunctionproperlyorrequiresmaintenance,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. 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. Environmental Requirements PhilipsMedicalSystemsisconcernedtohelpprotectthenaturalenvironment,andtohelp ensurecontinuedsafeandeffectiveuseofthisproduct,throughpropersupport,maintenance andtraining. ThereforePhilipsproductsaredesignedandmanufacturedtocomplywithrelevantguidelinesfor environmentalprotection.Aslongastheproductisproperlyoperatedandmaintained,it presentsnoenvironmentalrisks.However,theproductmaycontainmaterial(s),whichcouldbe harmfultotheenvironmentifdisposedofincorrectly.Useofsuchmaterial(s)isessentialto performingthefunctionsoftheproduct,andtomeetingstatutoryandotherrequirements. ThissectionoftheInstructionsforUseisdirectedmainlyattheuser/owneroftheproduct. Operatorsarenotusuallyinvolvedindisposal,exceptinthecaseofcertainbatteries;seepage 1422forthosedetails. ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting1417 Passing the Product on to another User Ifthisproductpassestoanotheruser,itmustbeinitscompletestate,includingallproduct supportdocumentation.MakethenewuserawareofthesupportservicesthatPhilipsMedical Systemsprovidesforinstalling,commissioningandmaintainingtheproduct.Beforepassingon theproductortakingitoutofservice,allpatientdatamustbe(backedupelsewhereifnecessary, and)unrecoverablebedeletedontheproduct. Itmustberememberedbyallexistingusersthatpassingonmedicalelectricalproductstonew usersmaycreateserioustechnical,medicalandlegal(e.g.onprivacy)risks.Suchriskscanarise eveniftheproductisgivenaway.Existingusersarestronglyadvisedtoseekadvicefromtheir localPhilipsMedicalSystemsrepresentativebeforecommittingthemselvestopassingonany product.Alternatively,contactthemanufacturer. Oncetheproducthasbeenpassedontoanewuser,aprevioususermaystillreceiveimportant safetyrelatedinformation,suchasbulletinsandfieldchangeorders.Inmanyjurisdictions,there isacleardutyontheprevioususertocommunicatesuchsafetyrelatedinformationtonewusers. PrevioususerswhoarenotableorpreparedtodothisshouldinformPhilipsMedicalSystems aboutthenewuser,sothatPMScanprovidethenewuserwithsafetyrelatedinformation. Packaging the MR400 TopackagetheMR400forshipment,usetheMR400packingmaterialstosafelytransportthe monitor.Removeallaccessoriesbeforepackaging. CAUTION If shipment of the MR400 is required, batteries must be removed prior to transport and internal batteries must be disconnected. TopacktheMR400 Step 1 2 Action InalocationoutsideoftheMRmagnetroom,ensurethattheAC mainspowerisdisconnected. Ensurethatbothmainbatterieshavebeenremovedandthatthe batteryswitchforthereservebatteriesisoff;seepage142. 1418MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Step 3 Action CoverthedisplaypanelandtheWPUwithprotectivefilmthen installfoamAoverthedisplaypanel. 4 Withthepackagingorientedsothattheslottedfoamwillbe nearestthetop,raisethecrateintoanuprightposition.Rollthe MR400intothecrateandthencarefullylowerthecrate. Slotted foam ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting1419 Step 5 Action Ensurethattheguidehandleislocatedintheslottedfoam(see step4)ifnecessary,pushtheMR400fromthebottom.Packthe MR400accessoriesintheaccessorybox(B)andthenplacethe accessoryboxintothecrate,alongsidethedisplaypanelasshown below.InsertfoamCovertheWPUandbetweenthebaseofthe MR400andthecrate. 6 Placethelidonthecrate. 1420MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse Step 7 Action Installalltheclipsintothelidonthecrate,ensuringthateachis lockedandthatthecrateissecure. Final Disposal of the Product Finaldisposaliswhentheuserdisposesoftheproductinsuchawaythatitcannolongerbe usedforitsintendedpurposes. WARNING Do not dispose of this product (or any parts of it) in industrial or domestic waste. The product 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. PhilipsHealthcaresupportsusersin:

Recoveringreusableparts. Recyclingofusefulmaterialsbycompetentdisposalcompanies. Safeandeffectivedisposalofequipment. Foradviceandinformation,contactyourPhilipsServiceOrganizationfirst,orotherwisethe manufacturer. Disposal of the MR400 and Accessories TheMR400cart,wirelessmodulesandaccessoriesaresubjecttostrictdisposalregulationsfor userandenvironmentalsafety.Neverdisposeofwasteelectricalandelectronicequipmentas ExpressionMR400InstructionsforUse MaintenanceandTroubleshooting1421 unsortedmunicipalwaste.Collectitseparatelysothatitcanbesafelyandproperlyreused, treated,recycledorrecovered. WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the MR400 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 MR400 and accessories as described in the service manual. Fitting, Removing and Disposing of Batteries REACHrequiresPhilipsHealthcare(PH)toprovidechemicalcontentinformationforSubstances ofVeryHighConcern(SVHC)iftheyarepresentabove0.1%oftheproductweight.Components withinelectricandelectronicequipmentmaycontainphthalatesabovethethreshold(e.g.,bis2 ethyl[hexyl]phthalate,CASnr.:117817).TheSVHClistisupdatedonaregularbasis.Therefore, refertothefollowingPhilipsREACHwebsiteforthemostuptodatelistofproductscontaining SVHCabovethethreshold:http://www.philips.com/about/sustainability/reach.page Thelithiumbatteriesfoundinthesystemandsomeoftheaccessoriesoroptionalequipment maybesubjecttostrictdisposalregulationsforuserandenvironmentalsafety.Observeand adheretoyourcurrentlocalregulationswhendisposingofbatteries. 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 above.) 1422MaintenanceandTroubleshooting ExpressionMR400InstructionsforUse APPENDIX A Specifications Patient Safety General ConformstoANSI/AAMIES606011.CertifiedtoCAN/CSAC22.2No.60601108;IEC6060112 Conformsto93/42/EECasamendedby2007/47/EEC,MedicalDeviceDirective Defibrillatorprotectionupto5KVDC Accordingtothedegreeofingressprotection:RatedIP21

(Protectedagainstaccesstohazardouspartsandtheingressofsolidforeignobjectsgreaterthan12.5mm(0.5inch), andagainstverticallydrippingliquid.) Whereappropriate,theequipmentcomplieswithworldwidestandardsforsafetyandperformanceofeachsystem feature,whenconsideringtheindicationsforusewithintheMRenvironment.Thisequipmentcomplieswiththe followinginternationalindustrystandardsforsafetyandperformance:

ISO14971,MedicaldevicesApplicationofriskmanagementtomedicaldevices IEC606011,MedicalElectricalEquipmentPart1:GeneralRequirementsforSafety(Amendment1)IEC60601 1,clause16,MedicalElectrical(ME)Systems ETSIEN3004401,ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Shortrangedevices;

Radioequipmenttobeusedinthe1GHzto40GHzfrequencyrange ETSIEN3004402,ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Shortrangedevices;

Radioequipmenttobeusedinthe1GHzto40GHzfrequencyrange ETSIEN3014891,ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Electromagnetic Compatibility(EMC)standardforradioequipmentandservices;Part1:CommontechnicalrequirementsV1.5.1 ETSIEN3014893,ElectromagneticCompatibilityandRadioSpectrumMatters(ERM);Electromagnetic Compatibility(EMC)StandardforRadioEquipmentandServices;Part3:SpecificConditionsforShortRange Devices(SRD)OperatingonFrequenciesbetween9KHzand40GHzV1.4.1 EN980:Symbolsforuseinlabelingofmedicaldevices EN1041:Informationsuppliedbythemanufacturerofmedicaldevices BSEN124704:2001+A1:2009,ClinicalThermometersPart4:PerformanceofElectricalThermometersfor ContinuousMeasurement IEC6006821,EnvironmentalTestingPart21:TestTestA:Cold IEC6006822,EnvironmentalTestingPart22:TestTestB:DryHeat IEC6006826,EnvironmentalTestingPart2:TestsTestFE:Vibration(Sinusoidal) IEC60068227,EnvironmentalTestingPart2:TestsTestEBandGuidance:Bump IEC60068264,EnvironmentalTestingPart2:TestMethodsTestFH:VibrationBroadbandRandom(Digital Control)andGuidance IEC6060112,MedicalElectricalEquipmentPart12:GeneralRequirementsforSafetyCollateralStandard:

ElectromagneticCompatibilityRequirementsandTests ExpressionMR400InstructionsforUse SpecificationsA1 General IEC60068264,EnvironmentalTestingPart2:TestMethodsTestFH:VibrationBroadbandRandom(Digital Control)andGuidance IEC6060112,MedicalElectricalEquipmentPart12:GeneralRequirementsforSafetyCollateralStandard:

ElectromagneticCompatibilityRequirementsandTests IEC6060116,MedicalElectricalEquipmentPart16:GeneralRequirementsforSafetyCollateralStandard:

Usability IEC6060118,MedicalElectricalEquipmentPart18:GeneralRequirementsforBasicSafetyandEssential PerformanceCollateralStandard:GeneralRequirements,TestsandGuidanceforAlarmSystemsinMedical ElectricalEquipmentandMedicalElectricalSystems IEC60601227,ParticularRequirementsforSafetySpecificationforElectrocardiographicMonitoring Equipment IEC60601233,Particularrequirementsforthesafetyofmagneticresonanceequipmentformedicaldiagnosis IEC60601234,MedicalElectricalEquipmentPart234:ParticularRequirementsfortheSafety,Including EssentialPerformance,ofInvasiveBloodPressureMonitoringEquipment IEC60601249,MedicalElectricalEquipmentPart249:ParticularRequirementsfortheSafetyof MultifunctionPatientMonitoringEquipment IEC80601230,MedicalElectricalEquipmentPart230:ParticularRequirementsfortheSafety,Including EssentialPerformance,ofAutomaticCyclingNonInvasiveBloodPressureMonitoringEquipment ISO80601261,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential PerformanceofPulseOximeterEquipmentforMedicalUse ISO80601255,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential PerformanceofRespiratoryGasMonitorsandPart255 DangerousGoodsRegulations2008,DangerousGoodsRegulations2008UNID3090 UNDOTT1T8,UNTransportTestingforSecondaryLithiumCells ISTAProcedure1A,FixedDisplacementVibrationandShockTestingforPackagedProductsweighing150lb(68 kg)orless Directive2011/65/EU,Restrictionoftheuseofcertainhazardoussubstancesinelectricalandelectronic equipment(RoHS2) ISO109931,BiologicalEvaluationofMedicalDevicesPart1:EvaluationandTesting ISO109935,BiologicalEvaluationofMedicalDevicesPart5:TestsforCytotoxicity:Invitromethods ISO1099310,BiologicalEvaluationofMedicalDevicesPart10:TestsforIrritationandDelayedType Hypersensitivity 21CFRPart801,CodeofFederalRegulationsMedicalDevices:Labeling 49CFRPart173.185,CodeofFederalRegulationsTransportationOtherRegulationsRelatingto TransportationPipelineandHazardousMaterialsSafetyAdministration,DepartmentofTransportation HazardousMaterialsRegulationsShippersGeneralRequirementsforShipmentsandPackagingsNonbulk packagingforhazardousmaterialsotherthanclass1andclass7Lithiumcellsandbatteries 1999/5/EC,R&TTEDirective(RadioandTelecommunicationsTerminalEquipment) A2Specifications ExpressionMR400InstructionsforUse General 2002/96/EC,DirectiveonWasteofElectricalandElectronicEquipment 2006/66/EC,BatteryDirective ANSI/AAMIBP22,BloodPressureTransducers ANSI/AAMIEC13,CardiacMonitors,HeartRateMeters,andAlarms ANSI/AAMIEC53,ECGtrunkcablesandpatientleadwires ASTME11122000,StandardSpecificationforElectronicThermometerforIntermittentDeterminationof PatientTemperature ASTMF205214,StandardTestMethodforMeasurementofMagneticallyInducedDisplacementForceon MedicalDeviceinMREnvironment ASTMF250313,StandardPracticeforMarkingMedicalDevicesandotherItemsforSafetyintheMR Environment FCCPart15.249(47CFRPart15.249),RadioFrequencyDevicesOperationwithinthebands902928MHz, 24002483MHz,57255875MHz,and24.024.25GHz UL2054,StandardforHouseholdandCommercialBatteries IEC62133,Secondarycellsandbatteriescontainingalkalineorothernonacidelectrolytes,Standardfor HouseholdandCommercialBatteries RSS210,Issue7,LowpowerLicenseexemptRadioCommunicationDevices(AllFrequencyBands):Category1 Equipment SAAAS/NZS3200.1.2,MedicalElectricalEquipmentPart12:GeneralRequirementsforSafetyCollateral Standard:ElectromagneticCompatibilityRequirementsandTests ISO141551,Clinicalinvestigationofmedicaldevicesforhumansubjects.Part1:Generalrequirements IEC62304,MedicalDeviceSoftware:Softwarelifecycleprocesses JIST0601234,MedicalElectricalEquipmentPart234:ParticularRequirementsfortheSafety,Including EssentialPerformance,ofInvasiveBloodPressureMonitoringEquipment JIST1306,ContinuousMeasuringClinicalElectricalThermometers ISO80601256,Medicalelectricalequipment.Part256:Particularrequirementsforbasicsafetyandessential performanceofclinicalthermometersforbodytemperaturemeasurement Power Requirements, Cart OperatingVoltageRange FrequencyRange Current PowerConsumption,Maximum Protection 100to240VAC,10percent 50to60Hz,singlephase 1.4A@100VAC/0.7A@240VAC 65Watts Internallyfused(3.15A,slowblow@250VAC),AClineand neutral ExpressionMR400InstructionsforUse SpecificationsA3 Battery Type OperationTime

(Fullycharged) ChargeTime MinimumVoltage

(Fornormaloperation) Capacity Environment OperatingTemperatureRange StorageandTransportTemperatureRange General Cart:LithiumIon Module:Lithiumpolymer Cart:Dependentuponenabledparametersandsettings:

Alldisplays,alarms,andmonitoringfunctionscontinuously for8hours ECG&SPO2continuouslyfor8hours CO2continuouslyfor6hours(withorwithoutAGENT) P1andP2continuouslyfor6hours AGENTanalysiscontinuouslyfor6hours Temperaturecontinuouslyfor6hours NIBPreadingsevery5minutesfor6hours Module:Approximately8hours Cart:Torechargeafullydischargedbatteryisapproximately12 hourswiththeMR400turnedoff.Batterychargetimeto90 percentofcapacityisapproximately6hours. Module:Torechargeafullydischargedbatteryisapproximately4 hours.Batterychargetimeto90percentofcapacityislessthan4 hours. Cart:14.4V Module:3.7V Cart:75Wh Module:3.1Wh 10to35C(50to95F) Batteries:0to40C(32to104F) Cart:20to60C(4to140F) Wirelessmodulesandallotheraccessoriesnotspecifiedbelow:

20to60C(4to140F) ECGskinprepgel:Followinstructionsontube Quadtrodes:10to32C(50to90F) Transducerandcable(optional)(REF989803179721):15to60C

(50to140F) O2sensor(AGENToption),StorageTemperature:+5to25C(+41 to77F);TransportTemperature40to50C(40to122F)

(Whenstoringortransportingintemperaturesbeyondtheranges specifiedabove,removethedesignatedcomponentandstoreor moveitappropriately.) A4Specifications ExpressionMR400InstructionsforUse RelativeHumidityRange OperatingPressureRange StorageandTransportPressureRange MRISystemRange General 5to80percent,noncondensing PhilipsIBPTransducerandcable(optional):15to80percent,non condensing Upto3,000m(9,842ft)abovesealevel(708mbaror531mmHg) 708mbar(708hPAor531mmHg)to1020mbar(1020hPAor765 mmHg) 0.7to3.0Tesla,atRFpowerlevelsnotexceeding4W/kgSAR,and 7.2TB1rmsinallorientations Dimensions and Weights

(Allmeasurementsmadewithbatteriesbutwithoutaccessories;fullyloadedcartweightalsoprovided) Height Width Depth Weight Display Type DriveSystem ScreenSize AspectRatio Area Pixels DotPitch PixelPitch ContrastRatio Backlight PolarizerSurface Tilt Cart:127.3cm(50.1inches) WirelessECGpatientmodule:18.2cm(7.17inches) WirelessSpO2patientmodule:13.0cm(5.13inches) Cart:47.5cm(18.7inches) WirelessECGpatientmodule:6.7cm(2.65inches) WirelessSpO2patientmodule:6.5cm(2.55inches) Cart:55.9cm(22inches) WirelessECGpatientmodule:3.1cm(1.24inches) WirelessSpO2patientmodule:3.1cm(1.24inches) Cart:46.9kg(103.3pounds);fullyloaded:50.2kg(110.7pounds) WirelessECGpatientmodule:340g(12ounces) WirelessSpO2patientmodule:204g(7.2ounces) LiquidCrystalDisplay(LCD),touchscreen,color aSiTFTactivematrix 39.5cm(15.6inches)diagonal 16:9 344.2(H)by193.5(V)mm 1366(H)by768(V)pixels 0.084(H)by0.252(V)mm 0.252(H)by0.252(V)mm 500:1(typical) LED Antiglare Adjustable,5to35 ExpressionMR400InstructionsforUse SpecificationsA5 SweepSpeed WaveformDisplayMode WaveformDisplayHeight(ECG,SingleTrace) WaveformDisplayHeight(ECG,DualTrace) WaveformDisplayHeight(SPO2,CO2,P1,P2) WaveformDisplayLength BatteryIndication AlarmLight,PriorityIndication AlarmVisibility AlarmSoundVolume AlarmSound,PriorityIndication General ForECG,SPO2,andIBP,aspeedof25mm/secondgives9.1 secondsofdisplaytime,while50mm/secondgives4.6seconds. Forrespiration,aspeedof3.125,6.25,12.5or25mm/secondis provided. Fixedtrace,movingerasebar 40mm 20mm 25mm 228mm Timeremaining,redlowwarning High:Red,flashing,1.5Hzwitha50%dutycycle Medium:Yellow,flashing,0.75Hzwitha50%dutycycle INOP:Blue,steady Legibleat1meter(assumingavisualacuityof20/20andwithno lineofsightobstructions) Atthemaximumsetting(10):86dB Threetonesoffixedpitchmnemonicnotes:

High:ccccc Medium:ccc INOP:ec Communication Attenuation 110dBconducted Time Alarms Displayed Information Batterybackedquartzcrystalclock Highandlowlimitsselectableforpatientparameters Note No algorithms were used to determine the manufacturer configured alarm presets. ECG ECGwaveformscale,displayedleads(2) A6Specifications ExpressionMR400InstructionsforUse HeartRate PulseOximeter Trends CO2 NIBP RespirationRate N2O O2 AGENT Displayed Information Automaticmodeselectsthevitalsigntoprovidetheheartrate accordingtovitalsignsourceavailabilityandpriority.Ifnosource available(ifnovitalsignmeetsthecriteria,thentheheartrate sourcewillbedisplayedasNoneandnoheartratewillbe produced. Manualmodeselectiontoprovidetheheartrateisalsoavailable. Pulserate,pulsewaveform(normalized)andpercentsaturation Heartrate,respirationrate,P1and/orP2(systolic,diastolic, mean),NIBP(systolic,diastolic,mean),EtCO2,O2,N2O,SpO2, andAgents BothendtidalandfractionalinspiredCO2 Pressures(systolic,mean,diastolic)andstatus RespirationratederivedfrombellowsorCO2 EtN2OavailableinAgentMACbox FiN2Onotdisplayed Inspired,endtidal(averagedpercent) Automaticidentificationofprimaryandsecondaryagents

(Desflurane,Isoflurane,Enflurane,HalothaneorSevoflurane) displayingbothendtidal(Et)andfractionalinspired(Fi) concentrations. Temperature Bodytemperature(CorF) ECG ECG Amplifier Protectedagainstdefibrillatorandelectrosurgerypotentials StandardLeadConfigurations LeadFail ECGInputImpedance ElectrodeContactImpedance Heart Rate Resolution PulseRateRange Accuracy I,II,III,AVR,AVL,AVF Passive,sensingsignalimbalance

>2.5M,singleended(accordingtoIEC60601227,50.102.3) 20Kohms@10Hz 1beatperminute(BPM) 30to250BPM(Adult) 30to300BPM(Neonate,Pediatric) 1percentor1BPM,whicheverisgreater. ExpressionMR400InstructionsforUse SpecificationsA7 ECG Adultpatienttype:>200V Neonate/Pediatricpatienttype:>100V Adultpatienttype:70to120ms Neonate/Pediatricpatienttype:40to120ms 0.5to40Hz Automaticallyremoved 2mVwitha1mVQRSamplitude(Monitormode) DetectionbyDCcurrentwaveformof<100nA,notapplied Cardiotach Sensitivity(Monitorfiltermode) QRSDuration Bandwidth(Monitorfiltermode) BaselineOffset TallTWaveRejectionCapabilityforHeartRate Indication LeadsoffSensing Alarm Limits (HR) Lower Upper Test/Calibrations SquareWaveTestSignal ECG Supplemental Information, as required by IEC 60601-2-27 HeartRate(HR)AveragingMethod Off,or30to250BPM 60to250BPM,oroff 60BPM1BPM,1mV10percent FifteenpointmedianfilteremployedwheretheBPMheartrateis computedbytakingthemeanofthethreemiddleelements. Updaterateofthedisplayis2Hz. 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:10.6seconds Gain2.0(8.8,9.1,10.3,9.4,12.1)Average:9.9seconds Gain0.5(9.0,10.4,12.3,8.1,10.4)Average:10.0seconds Gain1.0(8.4,7.7,12.5,7.7,8.3)Average:8.9seconds Gain2.0(9.7,12.6,8.9,11.8,8.3)Average:10.3seconds 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 HRchangefrom80to120BPM:8.3secaverage HRchangefrom80to40BPM:7.9secaverage A8Specifications ExpressionMR400InstructionsforUse HeartRateMeterAccuracyandResponseto IrregularRhythm ECG 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. Pulse Oximeter Pulsetonepitchismodulatedbythesaturationvalue. SaturationRange 1to100percent,inclusive SaturationValueResolution 1percent SaturationAccuracy PulseAccuracy PulseRateRange PulseRateResolution DataUpdatePeriod DataUpdatePeriodduringAlarm 3percentat70100percent 2percentor1beatperminute(BPM),whicheverisgreater 30to250BPM,inclusive 1BPM 5,10,or15seconds(accordingtotheSPO2AveragingTime setting) 9,14,or19seconds,maximum(4secondsplustheSPO2 AveragingTimesettingof5,10,or15seconds) WavelengthRange 500to1000nm Note Information about wavelength range can be especially useful to clinicians. EmittedLightEnergy PulseOximeterCalibrationRange Alarm Limits Lower Upper

<15mW 70to100percent Off,or50to100percent 70to100percent,oroff ExpressionMR400InstructionsforUse SpecificationsA9 WhenHRisderivedfromSPO2 Lower Upper Pulse Oximeter Off,or30to250BPM 60to250BPM,oroff 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 19 27 years of age light to black skin tones Reference method for the computation of pulse rate accuracy made using an electronic pulse simulator. (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 80601-2-61:2011, it is possible that only two-thirds of the measurements will fall within 3 percent of the value measured by the CO-Oximeter. CO2 (Optional LoFlo) Sidestream,nondispersiveinfraredabsorptiontechnique,includesmultiplefiltrationsystemandmicroprocessor logiccontrolofsamplehandlingandcalibration.MethodfordeterminingendtidalCO2measurement:Measures peakoftheendtidalCO2waveformevery20seconds. Output InitializationTime ZeroCalibrationInterval CO2UnitofMeasure CO2Resolution FlowRate DataSampleRate CO2waveform,EtCO2andFiCO2measurementnumericvalues, andrespirationrate Waveformdisplayedinlessthan20seconds,atanambient temperatureof25C(77F);fullspecificationsattainedwithin2 minutes Automaticoruserrequested Millimetersofmercury(mmHg)orkilopascals*(kPa) 1mmHg(0.1kPa) 50mL/minute10mL/minute 100Hz EndtidalCO2(EtCO2)MeasurementRange

(InwhichtheCO2accuracyspecificationismet) 0to76mmHg(0to10.1kPa)forrespirationratesrangingfrom4 to60breathsperminute,inclusive A10Specifications ExpressionMR400InstructionsforUse CO2 (Optional LoFlo) FractionalinspiredCO2(FiCO2)Measurement Range 3to50mmHg(0.4to6.7kPa) Method:LowestreadingoftheCO2waveformintheprevious20 seconds CO2Accuracy

(Allmeasurementsatgastempof25C) 4mmHg(0.5kPa)or12percent,whicheverisgreater,after thespecifiedwarmupperiod CO2Stability ShortTermDrift LongTermDrift RespirationAccuracy RespirationResolution RespirationRateRange

(Inwhichtherespirationaccuracyspecification ismet) Nottoexceed0.8mmHg(0.1kPa)overa4hourperiod Accuracyspecificationmaintainedovera120hourperiod 1breathor3percent,whicheverisgreater 1breathperminute 4to100breathsperminute,inclusive Note A simulator was used to simulate breathing rates and calibrated gas was flowed through the simulator and into the system, and effects on accuracy were recorded to determine the rated respiration rate range and the corresponding effects of end-tidal gas reading accuracy as a function of respiratory rate. Accessoryusage Functionalwithoutchangingaccessoriesforaminimumof6 hours SystemResponseandRiseTimes

(Asmeasuredfromthepatientgasinputofthe completepneumaticcircuit,includingtubing, from1090percentofthemeasuredCO2lev els) AirwayAdapter CO2Cannula DividedCannula Systemresponse:10.89seconds Risetime:0.94seconds Systemresponse:12.44seconds Risetime:1.12seconds Systemresponse:16.17seconds Risetime:2.01seconds ExpressionMR400InstructionsforUse SpecificationsA11 CO2 (Optional LoFlo) Compensations

(AutomaticCO2ambientpressure compensation400800mmHg[53.3106.6 kPa]) ForendtidalO2balancegas(N2,N2O,O,He)andanesthetic agentsB Usesgascompensationinformationtocorrecttherawcarbon dioxidevalue AnestheticAgentEffects

(MACLevels) CrosssensitivityCompensationError

(Additionalworstcaseerrorwhen compensationforO2,N2O,anestheticagents, orheliumiscorrectlyselectedfortheactual fractionalgasconstituentspresent.) Quantitativeeffectsofgassamplehumidityor condensate**:

AnestheticAgentSensitivityA(uncompensated):Accuracy specificationwillbemaintainedforhalogenatedanesthetic agentspresentatacceptedMAC(MinimumAlveolar Concentration)clinicallevels. AnestheticAgentSensitivity(compensated):Testingatagent levelsdefinedbyacceptedregulatorystandards(60601255) 0to40mmHg:1mmHgadditionalerror

(0to5.3kPa:0.1kPaadditionalerror) 41to70mmHg:2.5mmHgadditionalerror

(5.5to9.3kPa:0.3kPaadditionalerror) 71to100mmHg:4mmHgadditionalerror

(9.5to13.3kPa:0.5kPaadditionalerror) 101to150mmHg:5mmHgadditionalerror

(13.5to20kPa:0.6kPaadditionalerror) 0to40mmHg:2mmHg

(0to5.3kPa:0.2kPa) 41to70mmHg:5percent

(5.5to9.3kPa:5percent) 71to100mmHg:8percent

(9.5to13.3kPa:8percent) 101to150mmHg:10percent

(13.5to20kPa:10percent)

**Withappropriatecompensationsapplied Note There are no known adverse effects on stated performance due to cyclical pressure of up to 10 kPa (100 cmH2O). CalibrationInterval Calibrationverificationmustbeperformedat1yearintervals. A12Specifications ExpressionMR400InstructionsforUse Alarm Limits EndtidalCO2 Lower Upper FractionalinspiredCO2 Lower Upper Respiration Lower Upper CO2 (Optional LoFlo) Off,or5to60mmHg(Off,or0.7to8.0kPa) 5to90mmHg,oroff(0.7to12.0kPa,oroff) Nolowalarm;

0to20mmHg,oroff(0to2.7kPa,oroff) Off,or4to40RPM 20to100RPM,oroff

*Forkilopascals(kPa),allow1leastsignificantdigittoaccommodateroundofferrorforcalculatedvalues. A. GAS or Vapor Halothane Enflurane Isoflurane Desflurane Sevoflurane MAC Level, % vol fraction 0.77 1.70 1.15 6.00 2.10 N2O 105

(FromISO80601255.FDArecommendedforahealthy40yearoldmale.) B. Measured Gas Carbon Dioxide N2O NE @

60%

No Effect (NE) Quantitative Effects of Gas or Vapor 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%

Minimal Effect 1 (ME1) = Negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38 mmHg Minimal Effect 2 (ME2) = Concentrations greater than 5% will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38 mmHg

***Metered dose inhaler propellants: Unspecified Invasive Blood Pressure (Optional) Pressure Amplifier IsolationVoltage SignalRange Sensitivity GainAccuracy Bandwidth 5KVDC 30to+250mmHg 5V/V/mmHg 0.5percent 0to10Hz(3dB) ExpressionMR400InstructionsforUse SpecificationsA13 Invasive Blood Pressure (Optional) TransducerOffsetRange Transducer (REF 989803179721) OperatingPressure OverpressureLimits Sensitivity ZeroOffset ZeroDrift InputImpedance Auto Zero Range ZeroAccuracy ResponseTime Pressure Wave Display NumberofChannels ABP,PAPandLAP CVPandICP Pressure Scale Ranges

(UserSelectable) 300mmHg 50to300mmHg 400to5000mmHg 5V/V/mmHg1@6VDCand22C(71.6F)

<25mmHg

<2mmHgin8hours 300to350ohms

+300mmHg 1.0mmHg 1second,notifiesoperatorwhendone 0,1or2 Numericdisplayofsystolic,meananddiastolicpressures Numericdisplayofmeanpressureonly 0to250mmHg 0to200mmHg 0to150mmHg 0to100mmHg 0to75mmHg 0to45mmHg Pulse Rate (when derived from P1 or P2) Range Accuracy Resolution Alarm Delay TransducerDisconnect PressureDisconnect HighandLowPressure Alarm Limits WhenHRisderivedfromP1orP2 30to250BPM 2percentoffullscale 1BPM Sixseconds Sixseconds Tenseconds Lower Upper Systolic,Mean,Diastolic Lower Upper Off,or30to250BPM 60to250BPM,oroff Off,or30mmHgto250mmHg(Off,or4.0to33.3kPa) 30mmHgto250mmHg,oroff(4.0to33.3kPa,oroff) A14Specifications ExpressionMR400InstructionsforUse Invasive Blood Pressure (Optional) Transducer Adapter Cable Compatibility InvasivepressureinputmateswithanAmphenolconnector(MS3106A14S6P).Withthisconnectorandthe followingconnectioninformation,transduceradaptercablesmaybefabricatedororderedfromvarious manufacturers. ConnectorPinNumber A B C D E SignalName Signal

+Excitation

+Signal Excitation Shield SideStream,nondispersiveinfrared(NDIR)absorptiontechnique,includingwatertrapfiltrationsystemand microprocessorlogiccontrolofsamplehandlingandcalibration AGENT (Optional) Simultaneouslymeasuredgases Anytwoofthefollowing,inspiredorexpired,whilealsomeasuring CO2,N2O,andO2:

Halothane Isoflurane Sevoflurane Desflurane Enflurane MeasurementRange(aftermaximumwarm upperiod) Halothane:0to5.0Vol.%

Isoflurane:0to5.0Vol.%

Sevoflurane:0to8.0Vol.%

Desflurane:0to18.0Vol.%

Enflurane:0to5.0Vol.%

CarbonDioxide:0to10.0Vol.%

NitrousOxide:0to100Vol.%

ExpressionMR400InstructionsforUse SpecificationsA15 AGENT (Optional) Accuracy*(includesstabilityanddrift) Halothane:

Isoflurane:

Sevoflurane:

Desflurane:

Enflurane:

0.15Vol.%at0to1.00Vol%

0.20Vol%at1.00to5.00Vol%

Unspecified>5.00 0.15Vol.%at0to1.00Vol%

0.20Vol%at1.00to5.00Vol%

Unspecified>5.00 0.15Vol.%at0to1.00Vol%

0.20Vol%at1.00to5.00Vol%

0.40Vol%at5.00to8.00Vol%

Unspecified>8.00 0.15Vol%at0to1.00Vol%

0.20Vol%at1.00to5.00Vol%

0.40Vol%at5.00to10.00Vol%

0.60Vol%at10.00to15.00Vol%

1.0Vol%at15.00to18.00Vol%

Unspecified>18.00 0.15Vol.%at0to1.00Vol%

0.20Vol%at1.00to5.00Vol%

Unspecified>5.00 CarbonDioxide: 0.10Vol%at0to1.00Vol%

0.20Vol%at1.00to5.00Vol%

0.30Vol%at5.00to7.00Vol%

0.50Vol%at7.00to10.00Vol%

Unspecified>10.00 2.00Vol%at0to20Vol%

3.00Vol%at20.0to100Vol%

NitrousOxide:

InterferenceGas FlowRate(fixed) CO2:N2O,O2,AnyAgent=0.1%ABSinaccuracyallowanceforeach N2O:CO2,O2,AnyAgent=0.1%ABSinaccuracyallowanceforeach Agents:CO2=0%ABSinaccuracyallowance N2O,O2,2ndAgent=0.1%ABSinaccuracyallowanceforeach 20020ml/min(Adult,Pediatric) 15015ml/min(Neonate) Maximumspecifiedintervalforintervention ofwater(hoursatspecifiedminimumsample flowrate) AGENTmode:Adultandpediatricis17hours@200ml/min,37C, 100%RH;neonateis17hours@120ml/min,37C,100%RH CO2mode:8hours@50mL/min+/10ml/min A16Specifications ExpressionMR400InstructionsforUse AGENT (Optional) SystemResponseandRiseTimes

(Asmeasuredfrompatientgasinputofthe completepneumaticcircuit,includingtubing, from1090percentofmeasuredlevels) Cannula,Adult Halothane Systemresponse:11.56seconds Risetime:5.77seconds Enflurane Systemresponse:7.55seconds Risetime:1.75seconds Isoflurane Systemresponse:6.71seconds Risetime:0.88seconds Sevoflurane Systemresponse:6.45seconds Risetime:0.62seconds Desflurane Systemresponse:6.63seconds Risetime:0.57seconds Oxygen Systemresponse:6.99seconds Risetime:1.02seconds Nitrousoxide Systemresponse:6.28seconds Risetime:0.25seconds CO2 Systemresponse:6.62seconds Risetime:0.61seconds ExpressionMR400InstructionsforUse SpecificationsA17 Cannula,Infant AGENT (Optional) Halothane Systemresponse:15.95seconds Risetime:8.63seconds Enflurane Systemresponse:11.98seconds Risetime:4.75seconds Isoflurane Systemresponse:9.26seconds Risetime:1.70seconds Sevoflurane Systemresponse:6.48seconds Risetime:0.62seconds Desflurane Systemresponse:6.47seconds Risetime:0.61seconds Oxygen Systemresponse:8.61seconds Risetime:1.13seconds Nitrousoxide Systemresponse:7.95seconds Risetime:0.72seconds CO2 Systemresponse:6.51seconds Risetime:0.48seconds A18Specifications ExpressionMR400InstructionsforUse DividedCannula,Adult AGENT (Optional) Halothane Systemresponse:20.81seconds Risetime:14.18seconds Enflurane Systemresponse:13.83seconds Risetime:7.11seconds Isoflurane Systemresponse:10.99seconds Risetime:3.91seconds Sevoflurane Systemresponse:7.48seconds Risetime:0.78seconds Desflurane Systemresponse:7.38seconds Risetime:0.64seconds Oxygen Systemresponse:8.02seconds Risetime:1.07seconds Nitrousoxide Systemresponse:7.16seconds Risetime:0.51seconds CO2 Systemresponse:7.57seconds Risetime:0.64seconds ExpressionMR400InstructionsforUse SpecificationsA19 DividedCannula,Infant AGENT (Optional) Halothane Systemresponse:9.98seconds Risetime:3.95seconds Enflurane Systemresponse:7.32seconds Risetime:1.37seconds Isoflurane Systemresponse:6.75seconds Risetime:0.89seconds Sevoflurane Systemresponse:5.45seconds Risetime:0.67seconds Desflurane Systemresponse:6.25seconds Risetime:0.60seconds Oxygen Systemresponse:7.25seconds Risetime:0.84seconds Nitrousoxide Systemresponse:6.51seconds Risetime:0.39seconds CO2 Systemresponse:5.49seconds Risetime:0.49seconds DataSampleRate FullAccuracyRespirationRate

(Rangepermittingspecifiedgasaccuracy) 25Hz 2to60rpm Note A simulator was used to simulate breathing rates and calibrated gas was flowed through the simulator and into the system, and effects on accuracy were recorded to determine the rated respiration rate range and the corresponding effects of end-tidal gas reading accuracy as a function of respiratory rate. Endtidalgasreadings,calculationmethod EndtidalCO2concentrationreadingsareidentifiedbyusingthe highestvalueofthetemporalCO2curve.Correspondingreadingsof N2Oandanestheticagentsaretakenatthesamepointintime.End tidalO2concentrationreadingsareidentifiedbytheO2meanvalue duringtherespiratoryphaseasidentifiedbythetemporalCO2 curve.Oncecorrectlyidentified,thelowestO2concentration readingduringthephasewillbepresentedasendtidalO2. TotalRespirationRange 2to100rpm;accuracyisunspecifiedfrom60to100rpm A20Specifications ExpressionMR400InstructionsforUse AGENT (Optional) RelevantInterference 0.5mmHgequivalentwith37.5CsaturatedwithH2O(0.1% relative max) DisplayResolution 0.1percentvolume MaximumWarmupTime 10minutes;ISOaccuracyachievedin<45secondsofactivation AutoIDThreshold(fullaccuracymode) PrimaryAgentID:0.15%

SecondaryAgentID:0.3%

MultipleAgentsAlarmThreshold CO2AmbientPressureCompensationRange PressureCompensation CalibrationInterval Alarm Limits EtCO2 Lower Upper FiCO2 Lower Upper FiN2O Lower Upper EtHalothane Lower Upper FiHalothane Lower Upper EtIsoflurane Lower Upper 0.3%(0.5%duringISOaccuracymode)or5%REL(10%forIsoflurane) ofprimaryagentifprimaryagent>10%(ForHaladd0.1%ABSto thresholdvalues) 500mmHgto900mmHg Unaffectedbycyclicalpressuresofupto10kPaas,apartfromthe describedautomaticpressurecompensation,thepumpautomati callyregulatesflowsothatnotonlygasreadingsbutalsogassample flowisunaffected Calibrationverificationmustbeperformedat1yearintervals. Off,or5to60mmHg(Off,or0.68.0kPa) 5to90mmHg,oroff(0.712.0kPa,oroff) Nolowalarm;

0to20mmHg,oroff(0to2.7kPa,oroff) Nolowalarm;

0to80percent Off,or0.1to5.0Vol.%

0.1to5.0Vol.%,oroff Off,or0.1to5.0Vol.%

0.1to5.0Vol.%,oroff Off,or0.1to5.0Vol.%

0.1to5.0Vol.%,oroff ExpressionMR400InstructionsforUse SpecificationsA21 FiIsoflurane Lower Upper EtEnflurane Lower Upper FiEnflurane Lower Upper EtSevoflurane Lower Upper FiSevoflurane Lower Upper EtDesflurane Lower Upper FiDesflurane Lower Upper FiO2 Lowerandupper O2 Resolution Range SignalOutput(atconstanttemperatureand pressure) AGENT (Optional) Off,0.1to5.0Vol. %

0.1to5.0Vol. %,Off Off,0.1to5.0Vol. %

0.1to5.0Vol. %,Off Off,0.1to5.0Vol. %

0.1to5.0Vol. %,Off Off,0.1to8.0Vol. %

0.1to8.0Vol. %,Off Off,0.1to8.0Vol. %

0.1to8.0Vol. %,Off Off,0.1to18.0Vol. %

0.1to18.0Vol. %,Off Off,0.1to18.0Vol. %

0.1to18.0Vol. %,Off 18to100percent 1percent 0to100percent 10mV1.5mV@20C/20.95%O2 MaximumResponseTime(21%to100%step changethroughpatientsamplinglineasseen inWPUgasmonitorwindow) Adult/Pediatric<7.3seconds Neonate:<8.2seconds Accuracy(includesstabilityanddrift),full scale*

1%at0to40%

2%at40to60%

3%at60to80%

4%at80to100%

*Gasmeasurementperformancerequirementsaremetafterthemaximumwarmupperiod. A22Specifications ExpressionMR400InstructionsforUse Offset O2InterferingGasEffects:

N2O CO2 Halothane Enflurane Isoflurane Desflurane Sevoflurane Acetone Ethanol Helium Methane NitricOxide AGENT (Optional) 1percent

<0.3vol%@80vol%N2O

<0.3vol%@5vol%CO2

<0.3vol%@5vol%HAL

<0.3vol%@5vol%ENF

<0.3vol%@5vol%ISO

<0.3vol%@18vol%DES

<0.3vol%@8vol%SEV

<0.3vol%@1vol%Acetone

<0.3vol%@0.1vol%Ethanol

<0.3vol%@80vol%HE

<0.3vol%@0.1vol%Methane

<0.3vol%@50ppmNO OxygenSensor,OperatingTemperature 15to35C(59to95F) OxygenSensor,ExpectedOperatingLife Productlabeledwithausebydate;15monthsfrommanufacturing date(2500hoursat100percentO2).Exchangerecommendedevery 12months. CO2 Resolution Range 1percent 0to100percent Bellows Respiration RespirationRateMeasurementRange 0to60breathsperminute RespirationRateResolution RespirationRateAccuracy 1breathperminute 1breathperminute

(Allmeasurementsmadewithorwithoutasterilejacket) Temperature (Optional) Channel Units Range Resolution One Celsius(C)orFahrenheit(F) 20.0Cto44.0C(68.0Fto111.2F) 0.1C(0.1F) ExpressionMR400InstructionsforUse SpecificationsA23

(Allmeasurementsmadewithorwithoutasterilejacket) Temperature (Optional) Accuracy ResponseTime 0.5C(0.9F) Confirmingchangesinameasurementagainstothervitalsignmea surementsshouldbestandardroutineduringuse. Themeasuringtimetoobtainasteadystatereadingwithinthe manufacturersaccuracyspecificationsiswithin15seconds, complianttoISO80601256,Particularrequirementsforbasic safetyandessentialperformanceofclinicalthermometersforbody temperaturemeasurement. NumericDisplayUpdateTime 2seconds SensorType ApplicationSite MeasurementMode Alarm Limits Lower Upper Fiberoptic,multipleuse(whenusedwithsingleusesterilizedjack ets) Axillary,esophageal,rectal Direct Off,or20.0to44.0C(Off,or68.0to111.2F) 20.0to44.0C,oroff(68.0to111.2F,oroff) Non-Invasive Blood Pressure Oscillometrictechnology(withaninflatablecuff)determinessystolic,diastolicandmeanarterialpressures PatientTypes Pneumatic Systems CuffInflationPressure Adult,PediatricandNeonate Initial:165mmHg(22kPa)forAdult,130mmHg(17.3kPa)for Pediatric,and100mmHg(13.3kPa)forNeonate;allpressuresare 15mmHg(2kPa) SubsequentinflationpressuresdeterminedbylastNIBP measurement Automaticcuffpressurereleaseifinflationpressureexceeds300 mmHg(40kPa)forAdultandPediatricmodes,and150mmHg(20 kPa)forNeonatemode Millimetersofmercury(mmHg)orkilopascals*(kPa) 30to270mmHg(4.0to36kPa) 30to180mmHg(4.0to24kPa) 30to130mmHg(4.0to17.3kPa) OverpressureProtection UnitofMeasure Measurement Range Systolic Adult Pediatric Neonate A24Specifications ExpressionMR400InstructionsforUse Mean Adult Pediatric Neonate Diastolic Adult Pediatric Neonate Accuracy PressureMeasurementAccuracy PressureMeasurementResolution PressureTransducerRange Modes Manual Automatic Non-Invasive Blood Pressure 20to255mmHg(2.7to34kPa) 20to160mmHg(2.7to21.3kPa) 20to120mmHg(2.7to16kPa) 10to245mmHg(1.3to32.7kPa) 10to150mmHg(1.3to20kPa) 10to100mmHg(1.3to13.3kPa) Maximummeanerror5mmHg(0.6kPa)withastandarddeviation oflessthan8mmHg(1kPa) 1mmHg(0.1kPa) 0to300mmHg(0to40kPa) Immediateuponoperatorcommand Determinationsautomaticallymadewithselectableintervalsof1,2, 3,5,10,15,20,and30minutes ExpressionMR400InstructionsforUse SpecificationsA25 Non-Invasive Blood Pressure Notes The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion criteria. The NIBP clinical study was performed on adult and pediatric patients with the following attributes:

The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion criteria.Gender: 61% male, 39% female. No patients less than 29 days of age. Patients with limb circumferences ranged from 10.5 cm to 39 cm, with a distribution of 46 percent below 25 cm and 7 percent above 35 cm. The arterial systolic pressure ranges from 58 mmHg to 211 mmHg, with an average of 115 mmHg and with a distribution of 32.7 percent below 100 mmHg and 2.4 percent above 180 mmHg. The arterial diastolic pressure ranges from 34 mmHg to 131 mmHg, with an average of 65 mmHg and with a distribution of 42.3 percent below 60 mmHg and 3.9 percent above 100 mmHg. Patients with any sign of arterial disease were excluded. Patients with a heart beat greater than 180 BPM were excluded. The radial artery was acceptable as a reference site for all patients but one which used the femoral artery. The effectiveness was not validated on pregnant, including pre-eclamptic, patient populations. The NIBP clinical study was performed on neonatal patients with the following attributes:

No specified gender. All patients 28 days or less if born at term (37 gestation or more); otherwise, up to 44 gestational weeks. Patients with limb circumferences ranged from 5.75 cm to 13 cm with an average of 7.9 cm. The arterial systolic pressure ranged from 42 mmHg to 89 mmHg, with an average of 57 mmHg. The arterial diastolic pressure ranged from 20 mmHg to 62 mmHg, with an average of 34 mmHg. Arterial reference sites included the umbilical, femoral, brachial and radial artery. A26Specifications ExpressionMR400InstructionsforUse Alarm Limits Systolic Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Mean Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Diastolic Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Non-Invasive Blood Pressure Off,or30to270mmHg(Off,or4.0to36.0kPa) 30to270mmHg,oroff(or4.0to36.0kPa,oroff) Off,or30to180mmHg(Off,or4.0to24.0kPa) 30to180mmHg,oroff(or4.0to24.0kPa,oroff) Off,or30to130mmHg(Off,or4.0to17.3kPa) 30to130mmHg,oroff(4.0to17.3kPa,oroff) Off,or20to255mmHg(Off,or2.7to34.0kPa) 20to255mmHg,oroff(2.7to34.0kPa,oroff) Off,or20to160mmHg(Off,or2.7to21.3kPa) 20to160mmHg,oroff(2.7to21.3kPa,oroff) Off,or20to120mmHg(Off,or2.7to16.0kPa) 20to120mmHg,oroff(2.7to16.0kPa,oroff) Off,or10to245mmHg(Off,or1.3to32.7kPa) 10to245mmHg,oroff(1.3to32.7kPa,oroff) Off,or10to150mmHg(Off,or1.3to20.0kPa) 10to150mmHg,oroff(1.3to20.0kPa,oroff) Off,or10to100mmHg(Off,or1.3to13.3kPa) 10to100mmHg,oroff(1.3to13.3kPa,oroff)

*Forkilopascals(kPa),allow1leastsignificantdigittoaccommodateroundofferrorforcalculatedvalues. ExpressionMR400InstructionsforUse SpecificationsA27 GatingOutputs Gating connector pin-outs PinDesignator SignalName DescriptionandCharacteristics A B C D E F G H J Digitalgatingpulse Signalground RESP1VAnalog ECG1VAnalog P1200mVAnalog Negativegatingpulse SPO240mVAnalog ECG1mVAnalog SPO22VAnalog ECG/SPO2digitalgatingpulse:

Peaktopeakvoltage:3.3Vto5.0V Pulseduration:103ms Delay<10ms,ECG:MonitorandDefaultfiltermodes Delay<12ms,ECG:Advanced1filtermode Delay<14ms,ECG:Advanced2filtermode Delay<50ms,SPO2 Returnvoltagereferenceforallothersignalpins Analogrespirationgatingwaveformsignal:

Maximumoutputvoltage:5V Maximumcurrent:5mA Peaktopeaksignalvoltage:1V Delay=200ms AnalogECG1Voltwaveformsignal:

Bandwidth0.5to40Hz(Monitorfiltermode) Outputsignalscaling:1V/mV Maximumoutputvoltage:5V Maximumcurrent:5mA Delay<10ms AnalogP1gatingwaveformsignal:

Maximumoutputvoltage:200mV ECG/SPO2negativedigitalgatingpulse:

Peaktopeaksignalvoltage:3.3Vto5.0V AllothersignalcharacteristicssameasPinA(seeabove) SPO2IR/redanaloggatingwaveformsignal:

Signalscaling:1V/mV Maximumoutputvoltage:40mV Delay=250ms ECGanaloggatingwaveformsignal:

Signalscaling:1mV/mv Maximumcurrent:5mA Maximumoutputvoltage:20mV Bandwidth0.5to40Hz(Monitorfiltermode) Delay<10ms SPO2IR/redanaloggatingwaveformsignal:

Maximumoutputvoltage:2V Delay=250ms K,L,M,N,O Unused Unusedpins A28Specifications ExpressionMR400InstructionsforUse APPENDIX B Warranty Warranty Statement KoninklijkePhilipsN.V. warrantsthisproduct,otherthanitsconsumableparts,tobefreefrom defectsinmaterialsandworkmanshipforaperiodoftwelve(12)monthsfromthedateof originaldeliverytothebuyerortobuyer'sorder,providedthatsameisproperlyoperatedunder conditionsofnormaluse,andthatperiodicmaintenanceandserviceisperformed.Thissame warrantyismadeforaperiodofninety(90)daysonconsumableparts.Thiswarrantyshall becomenullandvoidiftheMR400hasbeenrepairedbysomeoneotherthanKoninklijkePhilips N.V. oriftheproducthasbeensubjecttomisuse,accident,negligenceorabuse. KoninklijkePhilipsN.V.ssoleobligationunderthiswarrantyislimitedtorepairinganMR400 whichhasbeenreportedtotheTechnicalServiceCenterduringnormalbusinesshoursand shippedtransportationprepaid.KoninklijkePhilipsN.V. shallnotbeliableforanydamages includingbutnotlimitedtoincidentaldamages,consequentialdamagesorspecialdamages. Thiswarrantyisinlieuofanyotherwarranties,guaranteesorconditions,including merchantabilityorfitnessforaparticularpurpose.Theremediesunderthiswarrantyare exclusiveandKoninklijkePhilipsN.V. neitherassumesnorauthorizesanyonetoassumeforitany otherobligationinconnectionwiththesaleorrepairofitsproducts. KONINKLIJKEPHILIPSN.V. PRODUCTSCONTAINPROPRIETARYCOPYRIGHTEDMATERIAL. ALLRIGHTSRESERVED ExpressionMR400InstructionsforUseWarrantyB1 B2WarrantyExpressionMR400InstructionsforUse 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.Inaddition,copiesmaybeobtainedfromInCenter. Authorized Representative TheAuthorizedRepresentativefortheEuropeanUnion(asrequiredbytheMedicalDevice Directive,93/42/EEC)isasfollows:

PhilipsMedizinSystemeBblingenGmbH HewlettPackardStrae2 71034,Bblingen Germany Australia TheAustraliaSponsorisasfollows:

PhilipsElectronicsAustraliaLtd 65EppingRoad,NorthRydeNSW2113 Australia ExpressionMR400InstructionsforUseRegulatoryInformationC1 C2RegulatoryInformationExpressionMR400InstructionsforUse APPENDIX D Gating Feature ThegatingfeatureintheMR400outputsdataanddiscretesignalstotheMRIscannersystem resultingfromthecollectionandprocessingofdatafromamonitoredparameter.Thescanner systemusesthesesignalsanddatatopreciselycontrolthetimesthatitcollectsMRimagedata fromthepatient. TwotypesofdatacanbeoutputbythegatingfacilityoftheMR400:

Analogwaveforms,whichareanalogelectronicrepresentationsofwaveformscollected frommonitoredparameters;and, Gatingpulses,whicharediscreteelectronicsignalsthatindicatethatsomephysiological eventassociatedwithamonitoredparameterhasoccurred. MR400 Preparation for Gating WhenpreparingtheMR400forgatingoftheMRsystem,ensurethatthecorrecttypeofgating cableisconnectedbetweentherearpaneloftheMR400andtheMRsystem. 1 1 Gating connector for connection of the gating cable to the MR system. Gating Connector Pin-outs GatingsignalsfromtheMR400areavailablethroughtheshieldedgatingconnectorlocatedon therearpanelofthecart(seeabove).Connectionsaremadeusingagatingcable.Gatingcables areavailableforeachmanufacturersMRIsystem(GEHorizonLX,SiemensHarmony,Siemens ExpressionMR400InstructionsforUse GatingFeatureD1 Symphony,SiemensAlvanto,PhilipsIntera,etcetera;seepage135).Fordetailedsignal characteristicsofthegatingoutputs,seeA28. Using the Gating Feature ThegatingfeatureprovidesfacilitiesforlowlatencyMRItriggeringandsynchronizationbasedon themeasuredECGorSPO2signal.DatameasuredandtransmittedbythewECGorwSpO2 moduleisprocessedbytheMR400andoutputatthegatingconnector;seepage119forthe location,andseethetableattheendofthisappendixforsignaldetails.(Signalscanalso transmittedbytheoptionalwBTU.) Using ECG Gating ToreceiveECGgatingsignals Step 1 Action CheckthebatteryindicatorsonthewECGmoduletoensurethat enoughchargeexistsinatleastoneoftheinstalledbatteries:

Greenbatteryindicator=Chargesufficient;proceedtostep3. Redbatteryindicator=Chargelow;proceedtostep2. Seepage29fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) Accordingtotheredbatteryindicator(s)presentonthewECG module,insertachargedmodulebatteryintothecorresponding batterybay(s)andthenrecheckthebatteryindicator(s)toensurea sufficientchargebeforeproceeding;seepage124. CheckthenetworkchannelindicatoronthewECGmoduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep5. Flashing=Nocommunication;proceedtostep4. Seepage210fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) EnsurethatthewECGmoduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129. Ensurethattheleadcableisproperlyattachedtothepatient;see AttachingtheECGLeadCableonpage512.

(ECGoutputsareenabledbydefault;seepage529.) ItmaybenecessarytouseTWaveSuppression,seepage533. 2 3 4 5 6 D2GatingFeatureExpressionMR400InstructionsforUse Step 7 Action Proceedaccordingtothetypeofgatingbeingused:

AnalogGatingToreceivetheanalogECGgatingwaveform throughtheMR400,ensurethatallofthefollowingconditions havebeenmet:

ThecorrectgatingcableisinstalledbetweentheMR400and theMRsystem;

ThesystemiscommunicatingwiththewECGmodule;

ThewECGmoduleisproperlyattachedtothepatient;and, LeadFaildoesnotexistforthemeasuredECGsignal. DigitalGatingToreceivethedigitalECGgatingpulsefromthe MR400,ensurethatallofthefollowingconditionshavebeenmet:

ThecorrectgatingcableisinstalledbetweentheMR400and theMRsystem;

ThesystemiscommunicatingwiththewECGmodule;

ThewECGmoduleisproperlyattachedtothepatient;

LeadFaildoesnotexistforthemeasuredECGsignal;

TheECGparameterhasbeenactivatedinthemenusystem;

and, TheECGsignalhasbeenselectedasthedigitalpulsesource, asfollows:

a. SelecttheECGVSbox. b. SelectGatingSource. c. SelectECG. ExpressionMR400InstructionsforUse GatingFeatureD3 Using SPO2 Gating ToreceiveSPO2gatingsignals Step 1 Action CheckthebatteryindicatoronthewSpO2moduletoensurethat enoughchargeexists:

Greenbatteryindicator=Chargesufficient;proceedtostep5. Redbatteryindicator=Chargelow;proceedtostep4. 2 3 4 5 6 7 8 9 Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) InsertachargedmodulebatteryintothewSpO2moduleandthen recheckthebatteryindicatortoensureasufficientchargebefore proceeding;seepage126. CheckthenetworkchannelindicatoronthewSpO2moduleto ensurecommunicationisestablishedwiththeMR400:

Steady=Goodcommunication;proceedtostep7. Flashing=Nocommunication;proceedtostep6. Seepage211fordetails.(Also,youcanreferencethestatus informationpane;seepage216.) Ensurethatthecorrectgatingcableisinstalledbetweenthe MR400andtheMRsystem. EnsurethatthewSpO2moduleiswithin9.1m(30feet)ofthe MR400,inthesameMRIroomorinthesameshieldedroom,andis settothesamewirelessnetworkchannelusedbytheMR400;see page129. EnsurethattheSPO2attachmentisproperlyattached;seeApply ingtheSPO2AttachmenttothePatientonpage63. SelecttheSPO2VSbox(seepage68). TheSPO2menuappears.Currentsettingsaredisplayed. SelectGatingSource. TheGatingSourcemenuappears;seepage515. SelectPulse. Thesettingisapplied. D4GatingFeatureExpressionMR400InstructionsforUse Guidelines and References APPENDIX E 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:

ExpressionMR400InstructionsforUseGuidelinesandReferencesE1 1. PreparethepatientfortheMRprocedurebyensuringthattherearenounnecessary metallicobjectscontactingthepatient'sskin(e.g.,metallicdrugdeliverypatches,jewelry, necklaces,bracelets,keychains,etcetera). 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,etcetera),andmaterialsthathavebeenthoroughlytestedanddeterminedto besafeandcompatibleforMRprocedures,aslistedinthisIFU. 5. CarefullyfollowspecificMRsafetycriteriaandrecommendationsforimplantsmadefrom electricallyconductivematerials(e.g.,bonefusionstimulators,neurostimulationsystems, etcetera). 6. Beforeusingelectricalequipment,checktheintegrityoftheinsulationand/orhousingof allcomponentsincludingsurfaceRFcoils,monitoringleads,cables,andwires.Preventive maintenanceshouldbepracticedroutinelyforsuchequipment. 7. RemoveallnonessentialelectricallyconductivematerialsfromtheMRsystem(i.e., unusedsurfaceRFcoils,ECGleads,cables,wires,etcetera). 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). E2GuidelinesandReferencesExpressionMR400InstructionsforUse 12. Donotpositionelectricallyconductivematerialsacrossanexternalmetallicprosthesis

(e.g.,externalfixationdevice,cervicalfixationdevice,etcetera)orsimilardevicethatisin directcontactwiththepatient. 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 ExpressionMR400InstructionsforUseGuidelinesandReferencesE3 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. E4GuidelinesandReferencesExpressionMR400InstructionsforUse 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. ExpressionMR400InstructionsforUseGuidelinesandReferencesE5 E6GuidelinesandReferencesExpressionMR400InstructionsforUse Notes Notes Notes Notes Notes Notes Notes Notes