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
A‐2Specifications ExpressionMR400InstructionsforUse
•IEC60068‐2‐64,EnvironmentalTesting–Part2:TestMethodsTestFH:VibrationBroad‐bandRandom(Digital
Control)andGuidance
•IEC60601‐1‐2,MedicalElectricalEquipmentPart1‐2:GeneralRequirementsforSafety‐CollateralStandard:
ElectromagneticCompatibility‐RequirementsandTests
•IEC60601‐
1‐6,MedicalElectricalEquipment‐Par t1‐6:GeneralRequirementsforSafety‐CollateralStandard:
Usability
•IEC60601‐1‐8,MedicalElectricalEquipment–Part1‐8:GeneralRequirementsforBasicSafetyandEssential
Performance–CollateralStandard:GeneralRequirements,TestsandGuidanceforAlarmSystemsinMedical
ElectricalEquipmentandMedical
ElectricalSystems
•IEC60601‐2‐27,ParticularRequirementsforSafety‐SpecificationforElectrocardiographicMonitoring
Equipment
•IEC60601‐2‐33,Particularrequirementsforthesafetyofmagneticresonance equipmentformedicaldiagnosis
•IEC60601‐2‐34,MedicalElectricalEquipment–Part2‐34:ParticularRequirementsfortheSafety,Including
EssentialPerformance,ofInvasive
BloodPressureMonitoringEquipment
•IEC60601‐2‐49,MedicalElectricalEquipment‐Part2‐49:ParticularRequirementsfortheSafetyof
MultifunctionPatientMonitoringEquipment
•IEC80601‐2‐30,MedicalElectricalEquipment‐Part2‐30:ParticularRequirementsfortheSafety,Including
EssentialPerformance,ofAutomaticCyclingNon‐InvasiveBloodPressureMonitoringEquipment
•ISO
80601‐2‐61,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential
PerformanceofPulseOximeterEquipmentforMedicalUse
•ISO80601‐2 ‐55,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential
PerformanceofRespiratoryGasMonitorsandPart2‐55
•DangerousGoodsRegulations2008,DangerousGoods
Regulations2008–UNID3090
•UNDOTT1‐T8,UNTransport TestingforSecondaryLithiumCells
•ISTAProcedure1A,FixedDisplacementVibrationandShockTestingforPackagedProductsweighing150lb(68
kg)orless
• Directive2011/65/EU,Restrictionoftheuseofcertainhazardoussubstancesinelectricalandelectronic
equipment(RoHS2)
•ISO10993‐1,BiologicalEvaluationofMedicalDevices‐Part1:EvaluationandTesting
•ISO10993‐5,BiologicalEvaluationofMedicalDevices‐Part5:TestsforCytotoxicity:Invitromethods
•ISO10993‐10,BiologicalEvaluationofMedicalDevices‐Part10:TestsforIrritationandDelayed‐Type
Hypersensitivity
•21CFRPart801,Codeof
FederalRegulations–MedicalDevices:Labeling
•49CFRPart173.185,CodeofFederalRegulations–Transportation–OtherRegulationsRelatingto
Transportation–PipelineandHazardousMaterialsSafetyAdministration,DepartmentofTransportation–
HazardousMaterialsRegulations–Shippers‐GeneralRequirementsforShipmentsandPackagings–Non‐bulk
packagingforhazardousmaterials
otherthanclass1andclass7–Lithiumcellsandbatteries
• 1999/5/EC,R&TTEDirective(RadioandTelecommunicationsTerminalEquipment)
General