User Manual
Table Of Contents
- Manufacturer
- Identification and Publication Details
- Regulatory
- Explanation of Symbols
- Conventions
- Important Information
- About
- Intended Use
- Compatibility
- Indications for Use
- Contra-indications
- Training
- Safety
- Electromagnetic Compatibility (EMC)
- Using Batteries Safely
- Examining the Shipment
- Initial Setup
- Rear Panel Connections
- Understanding Battery Operations
- Understanding Wireless Network Operations
- Advanced User Options
- Accessory List
- System Overview
- Getting Started
- Alarms
- Monitoring ECG
- ECG Monitoring Considerations for the MR Environment
- wECG Module and ECG Lead Cable
- Quadtrode Electrodes
- Work Flow for ECG Monitoring
- Selecting the ECG Lead Cable and Quadtrode Electrode Type
- Identifying the Placement Site for the Quadtrode Electrode
- Preparing the Quadtrode Electrode Site
- Attaching the ECG Lead Cable
- Checking the ECG Signal Strength
- Minimizing ECG Waveform Noise
- Positioning the ECG Lead Cable and wECG Module for Scanning
- ECG Waveforms and VS Box
- ECG Menu
- Monitoring SPO2
- Monitoring CO2 (LoFlo Option)
- Monitoring Invasive Blood Pressure
- Indications and Contraindications
- Patient Preparation for IBP Monitoring
- Transducer Component, Connection, and Feature Locations
- MR 400 Preparation for IBP Monitoring
- Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631)
- I. Connecting the Reusable Cable to the MR400
- II. Kit Set Up
- III. Purging Air from the Monitoring Line
- IV. Zeroing, Leveling and Calibration
- V. Connecting the Monitoring Kit to the Patient
- The IBP transducer must not be mounted to the patient, or patient burn may result.
- VI. Fast Flushing
- VII. Checking for Leaks
- VIII. In the MR Room
- Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641)
- Adult and Pediatric Patients: Expression MR IBP DPT Kit, A/P (REF 989803194631)
- Zeroing the Pressure Transducer
- P1 (and P2) Menu
- Monitoring Agents and Gases (AGENT Option)
- Monitoring RESP
- Monitoring Temperature
- Monitoring NIBP
- Trend Data and Printing
- Maintenance and Troubleshooting
- General Cleaning Guidelines
- Removing all Power to the MR400
- Removing Power from the Wireless Modules
- User Routine-Checks and Planned Maintenance
- Cleaning, Disinfection, and Damage Inspection
- Sterilization
- Testing Alarms
- Testing a Dropped Wireless Module
- Verification Testing
- Anesthetic Oxygen (O2) Sensor Depletion
- Updating Software
- Calibrating the Touch Screen
- Troubleshooting
- Repair
- Environmental Requirements
- Passing the Product on to another User
- Final Disposal of the Product
- Specifications
- Warranty
- Regulatory Information
- Gating Feature
- Guidelines and References
ExpressionMR400InstructionsforUse GuidelinesandReferencesE‐5
ShellockFG.MRsafetyupdate2002:Implantsanddevices.JournalofMagneticResonance
Imaging2002;16:485‐496.
ShellockFG.Radiofrequency‐inducedheatingduringMRprocedures:Areview.Journalof
MagneticResonanceImaging2000;12:30‐36.
ShellockFG.ReferenceManualforMagneticResonanceSafety:
2003Edition,Amirsys,Inc.,2003.
ShellockFG,SlimpG.SevereburnofthefingercausedbyusingapulseoximeterduringMRI.
AmericanJournalofRoentgenology1989;153:1105.
ShellockFG,HatfieldM,SimonBJ,BlockS,WamboldtJ,StarewiczPM,PunchardWFB.
Implantablespinalfusionstimulator: assessmentofMRIsafety.Journalof
MagneticResonance
Imaging2000;12:214‐223.
SmithCD,NyenhuisJA,KildishevAV.Healtheffectsofinducedelectricalfields:implicati onsfor
metallicimplants.In:ShellockFG,ed.Magneticresonanceprocedure:healtheffectsandsafety.
BocaRaton,FL:CRCPress,2001;393‐414.
U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH),
Medical
DeviceReport(MDR)(http://www.fda.gov/CDRH/mdrfile.html).Thefilescontaininformation
fromCDRH'sdeviceexperiencereportsondeviceswhichmayhavemalfunctionedorcauseda
deathorseriousinjury.ThefilescontainreportsreceivedunderboththemandatoryMedical
DeviceReportingProgram(MDR)from1984 ‐1996,andthevoluntaryreportsupto
June1993.
Thedatabasecurrentlycontainsover600,000reports.
U.S.FoodandDrugAdministration,CenterforDevicesandRadiologicalHealth(CDRH),
ManufacturerandUserFacilityDeviceExperienceDatabase,MAUDE,(http://www.fda.gov/cdrh/
maude.html).MAUDEdatarepresentsreportsofadverseeventsinvolvingmedicaldevices.The
dataconsistsofallvoluntaryreportssinceJune,1993,user
facilityreportssince1991,distributor
reportssince1993,andmanufacturerreportssinceAugust,1996.