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 SpecificationsA‐1
APPENDIX A
Specifications
General
Patient Safety
ConformstoANSI/AAMIES60601‐1.CertifiedtoCAN/CSAC22.2No.60601‐1‐08;IEC60601‐1‐2
Conformsto93/42/EECasamendedby2007/47/EEC,Medica lDeviceDirective
Defibrillatorprotectionupto5KVDC
Accordingtothedegreeofingressprotection:RatedIP21
(Protectedagainstaccesstohazardouspartsandtheingressof
solidforeignobjectsgreaterthan12.5mm(0.5inch),
andagainstverticallydripp i ngliquid.)
Whereappropriate, theequipmentcomplieswithworldwidestandardsforsafetyandperformanceofeachsystem
feature,whenconsideringthe indicationsforusewithintheMRenvironment.Thisequipmentcomplieswiththe
followinginternationalindustrystandardsforsafetyand
performance:
•ISO14971,Medicaldevices‐Applicationofriskmanagementtomedicaldevices
•IEC60601‐1,MedicalElectrical EquipmentPart1:GeneralRequirementsforSafety(Amendment1)IEC60601‐
1,clause16,MedicalElectrical(ME)Systems
•ETSIEN300‐440‐1,ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Shortrangedevices;
Radio
equipmenttobeusedinthe1GHzto40GHzfrequencyrange
•ETSIEN300‐440‐2,ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Shortrangedevices;
Radioequipmenttobeusedinthe1GHzto40GHzfrequencyrange
•ETSIEN301‐489‐1,ElectromagneticcompatibilityandRadiospectrum
Matters(ERM);Electromagnetic
Compatibility(EMC)standardforradioequipmentandservices;Part1:Commontechnicalrequirements‐V1.5.1
•ETSIEN301‐489‐3,ElectromagneticCompatibilityandRadioSpectrumMatters(ERM);Electromagnetic
Compatibility(EMC)StandardforRadioEquipmentandServices;Part3:SpecificConditionsforShort‐Range
Devices(SRD)OperatingonFrequenciesbetween
9KHzand40GHz‐V1.4.1
•EN980:Symbolsforusein labelingofmedicaldevices
•EN1041:Informationsuppliedbythemanufacturerofmedicaldevices
•BSEN12470‐4:20 01+A1:2009,ClinicalThermometers–Part4:PerformanceofElectricalThermometersfor
ContinuousMeasurement
•IEC60068‐2‐1,EnvironmentalTesting–Part2‐
1:Test–TestA:Cold
•IEC60068‐2‐2,EnvironmentalTesting–Part2‐2:Test–TestB:DryHeat
•IEC60068‐2‐6,EnvironmentalTesting–Part2:Tests–TestFE:Vibration(Sinusoidal)
•IEC60068‐2‐27,EnvironmentalTesting–Part2:Tests–TestEBandGuidance:Bump
•IEC60068‐2‐64,EnvironmentalTesting–Part
2:TestMethodsTestFH:VibrationBroad‐bandRandom(Digital
Control)andGuidance
•IEC60601‐1‐2,MedicalElectricalEquipmentPart1‐2:GeneralRequirementsforSafety‐CollateralStandard:
ElectromagneticCompatibility‐RequirementsandTests