User's Manual
Table Of Contents
- Manufacturer
- Copyright
- Equipment Classification
- Proprietary Information
- Chapter 1: Important Information
- Chapter 2: Getting Started
- Chapter 3: Preparation for Use
- Chapter 4: Monitoring SpO2
- Chapter 5: Workflow
- Chapter 6: Maintenance and Repair
- Appendix A: Specifications
- Appendix B: Warranty
- Appendix C: Regulatory Information
- Appendix D: Guidelines and References
- Notes
989803173791 Rev 0.6AppendixD:GuidelinesandReferences89
ShellockFG.Radiofrequency‐inducedheatingduringMRprocedures:Areview.Journalof
MagneticResonanceImaging2000;12:30‐36.
ShellockFG.ReferenceManualforMagneticResonanceSafety:2003Edition,Amirsys,Inc.,2003 .
ShellockFG,SlimpG.Severeburnofthefingercausedbyusingapulseoximeter
duringMRI.
AmericanJournalofRoentgenology1989;153:1105.
ShellockFG,HatfieldM,SimonBJ,BlockS,WamboldtJ,StarewiczPM,PunchardWFB.
Implantablespinalfusionstimulator: assessmentofMRIsafety.JournalofMagneticResonance
Imaging2000;12:214‐223.
SmithCD,NyenhuisJA,KildishevAV.Healtheffectsofinducedelectricalfields:implicationsfor
metallic
implants.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'sdeviceexperiencereportsondeviceswhichmayhave
malfunctionedorcauseda
deathorseriousinjury.ThefilescontainreportsreceivedunderboththemandatoryMedical
DeviceReportingProgram(MDR)from1984 ‐1996,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.