User Manual

ManualsBrandsInvivo ManualsElectronicsWireless ECG for Patient Monitoring in MRI Environments

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Table Of Contents

Manufacturer
Identification and Publication Details
Regulatory
Explanation of Symbols
Conventions
- System Conventions
- Document Conventions
Important Information
- About
- Intended Use
- Compatibility
- Indications for Use
- Contra-indications
- Training
- Safety
  - Equipment Classification (According to IEC 60601-1)
- Electromagnetic Compatibility (EMC)
  - Radios
- Using Batteries Safely
- Examining the Shipment
  - Disposing of the Packaging
- Initial Setup
  - Installing and Connecting Cart Batteries
  - Attaching the SpO2 Probe to the wSpO2 Module
- Rear Panel Connections
  - Connecting AC Mains Power
- Understanding Battery Operations
- Understanding Wireless Network Operations
  - Setting the Wireless Network Channel of the Cart
  - Setting the Wireless Network Channel of the wECG and wSpO2 Modules
- Advanced User Options
  - Expression Information Portal (Model IP5)
  - Additional Options
- Accessory List
System Overview
- System Parameters
- System Components
  - Use Model
- Hardware Features
- wECG and wSpO2 Modules
  - wECG Module
    - wECG Module Indicators
  - wSpO2 Module
    - wSpO2 Module Indicators
- Storing Modules and Accessories
- Displayed Information and Controls
- Navigation and Operation
- Modes of Operation
Getting Started
- Defibrillator and Electrosurgical Use
- Positioning the MR400
- Operating the MR400
  - System Power-up and Communications Verification
    - Cart Power-down
    - Wireless Module Power-down
- Monitor Initialization
- Viewing the Displayed Information
- Default Settings
  - Default Setting Indications
  - User Settings
- Initial Alarm Indications
- Selecting the Patient Type
- Setup Menus
  - Monitor Setup Menu
Alarms
- Alarm Safety Information
- Visual Alarm Indications
- Audible Alarm Indications
- Managing Alarm Functions
- Alarms Menu
- Adjustable Alarm Limit Ranges
- Alarm Limit Factory Defaults
- Measurement Limits and Over / Under Values
- Listing of Alarms
  - Patient and INOP Alarms
  - Technical (INOP) Alarms and Other Status Flags
Monitoring ECG
- ECG Monitoring Considerations for the MR Environment
- wECG Module and ECG Lead Cable
- Quadtrode Electrodes
- ECG Waveforms and VS Box
  - Changing the Heart Rate Alarm Limits
- ECG Menu
Monitoring SPO2
- wSpO2 Module, SpO2 Probe and SpO2 Attachment
- Patient Preparation for SpO2 Monitoring
- SPO2 Waveform and VS Box
- SPO2 Menu
Monitoring CO2 (LoFlo Option)
- MR400 Preparation for CO2 Monitoring
- Operation and Use
- Patient Preparation for CO2 Monitoring
- CO2 Waveform and VS Box
  - Changing the CO2 and CO2 (RESP) Alarm Limits
  - Changing the Unit of Measure
- CO2 Menu
Monitoring Invasive Blood Pressure
- Indications and Contraindications
  - Adult and Pediatric Patients
  - Neonatal Patients
- 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)
  - Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641)
- Zeroing the Pressure Transducer
- P1 (and P2) Menu
Monitoring Agents and Gases (AGENT Option)
- MR400 Preparation for AGENT Monitoring
- Operation and Use
- CO2 Low Flow and Occlusion Conditions
- Selecting AGENT Accessories
- AGENT Tubing Preparation
  - Pre-Use System Checks
  - Applying the Sampling Line to the Patient
- Water Trap Replacement
- AGENT and GAS VS Boxes
- MAC Window
- CO2 Waveform and VS Box
  - Changing the CO2 and CO2 (RESP) Alarm Limits
  - Changing the Unit of Measure
- CO2 Menu
Monitoring RESP
- Patient Preparation for RESP Monitoring
  - Monitoring Respiration using CO2
  - Monitoring Respiration using the Bellows
- Bellows Preparation
- Respiration VS Box
  - Changing the CO2 (RESP) Alarm Limits
- RESP Menu
Monitoring Temperature
- General Usage Precautions
- Initial Use
- Connecting and Disconnecting the Sensor
- Temperature Measurements
  - Making Surface Temperature Measurements
  - Making Body Temperature Measurements
    - Placing the Temperature Sensor in a Jacket
    - Placing the Temperature Sensor at the Body Site
- Post-Measurement Processing
- Accuracy Check
- TEMP VS Box
  - Changing the TEMP Alarm Limits
  - Changing the Unit of Measure
- TEMP Menu
  - Units
Monitoring NIBP
- Patient Preparation for NIBP Monitoring
  - Selecting the NIBP Cuff
  - Positioning the NIBP Cuff
- Connecting the NIBP Cuff
- NIBP VS Box
- NIBP Menu
Trend Data and Printing
- Trending Functions
  - Viewing Tabular Trend Data
  - Tabular Trends Menu
- Printing Functions
- Printer Menu
Maintenance and Troubleshooting
- General Cleaning Guidelines
- Removing all Power to the MR400
  - Restoring all Power to the MR400
- Removing Power from the Wireless Modules
  - Restoring Power to the Wireless Modules
- User Routine-Checks and Planned Maintenance
- Cleaning, Disinfection, and Damage Inspection
  - Cleaning, Disinfecting, and Inspecting the Accessories
  - Cleaning, Disinfecting, and Inspecting MR400 and Wireless Modules
- Sterilization
- Testing Alarms
- Testing a Dropped Wireless Module
- Verification Testing
- Anesthetic Oxygen (O2) Sensor Depletion
  - Replacing the O2 Sensor
- Updating Software
- Calibrating the Touch Screen
- Troubleshooting
- Repair
- Environmental Requirements
- Passing the Product on to another User
  - Packaging the MR400
- Final Disposal of the Product
  - Disposal of the MR400 and Accessories
  - Fitting, Removing and Disposing of Batteries
Specifications
- General
- Displayed Information
- ECG
- Pulse Oximeter
- CO2 (Optional LoFlo)
- Invasive Blood Pressure (Optional)
- AGENT (Optional)
- Bellows Respiration
- Temperature (Optional)
- Non-Invasive Blood Pressure
- Gating Outputs
Warranty
- Warranty Statement
Regulatory Information
- European Union
  - Declaration of Conformity
  - Authorized Representative
- Australia
Gating Feature
- MR400 Preparation for Gating
  - Gating Connector Pin-outs
- Using the Gating Feature
  - Using ECG Gating
  - Using SPO2 Gating
Guidelines and References
- Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic Resonance Procedures
- References

A‐2Specifications ExpressionMR400InstructionsforUse

•IEC60068‐2‐64,EnvironmentalTesting–Part2:TestMethodsTestFH:VibrationBroad‐bandRandom(Digital

Control)andGuidance

•IEC60601‐1‐2,MedicalElectricalEquipmentPart1‐2:GeneralRequirementsforSafety‐CollateralStandard:

ElectromagneticCompatibility‐RequirementsandTests

•IEC60601‐

1‐6,MedicalElectricalEquipment‐Par t1‐6:GeneralRequirementsforSafety‐CollateralStandard:

Usability

•IEC60601‐1‐8,MedicalElectricalEquipment–Part1‐8:GeneralRequirementsforBasicSafetyandEssential

Performance–CollateralStandard:GeneralRequirements,TestsandGuidanceforAlarmSystemsinMedical

ElectricalEquipmentandMedical

ElectricalSystems

•IEC60601‐2‐27,ParticularRequirementsforSafety‐SpecificationforElectrocardiographicMonitoring

Equipment

•IEC60601‐2‐33,Particularrequirementsforthesafetyofmagneticresonance equipmentformedicaldiagnosis

•IEC60601‐2‐34,MedicalElectricalEquipment–Part2‐34:ParticularRequirementsfortheSafety,Including

EssentialPerformance,ofInvasive

BloodPressureMonitoringEquipment

•IEC60601‐2‐49,MedicalElectricalEquipment‐Part2‐49:ParticularRequirementsfortheSafetyof

MultifunctionPatientMonitoringEquipment

•IEC80601‐2‐30,MedicalElectricalEquipment‐Part2‐30:ParticularRequirementsfortheSafety,Including

EssentialPerformance,ofAutomaticCyclingNon‐InvasiveBloodPressureMonitoringEquipment

•ISO

80601‐2‐61,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential

PerformanceofPulseOximeterEquipmentforMedicalUse

•ISO80601‐2 ‐55,MedicalElectricalEquipmentParticularRequirementsfortheBasicSafetyandEssential

PerformanceofRespiratoryGasMonitorsandPart2‐55

•DangerousGoodsRegulations2008,DangerousGoods

Regulations2008–UNID3090

•UNDOTT1‐T8,UNTransport TestingforSecondaryLithiumCells

•ISTAProcedure1A,FixedDisplacementVibrationandShockTestingforPackagedProductsweighing150lb(68

kg)orless

• Directive2011/65/EU,Restrictionoftheuseofcertainhazardoussubstancesinelectricalandelectronic

equipment(RoHS2)

•ISO10993‐1,BiologicalEvaluationofMedicalDevices‐Part1:EvaluationandTesting

•ISO10993‐5,BiologicalEvaluationofMedicalDevices‐Part5:TestsforCytotoxicity:Invitromethods

•ISO10993‐10,BiologicalEvaluationofMedicalDevices‐Part10:TestsforIrritationandDelayed‐Type

Hypersensitivity

•21CFRPart801,Codeof

FederalRegulations–MedicalDevices:Labeling

•49CFRPart173.185,CodeofFederalRegulations–Transportation–OtherRegulationsRelatingto

Transportation–PipelineandHazardousMaterialsSafetyAdministration,DepartmentofTransportation–

HazardousMaterialsRegulations–Shippers‐GeneralRequirementsforShipmentsandPackagings–Non‐bulk

packagingforhazardousmaterials

otherthanclass1andclass7–Lithiumcellsandbatteries

• 1999/5/EC,R&TTEDirective(RadioandTelecommunicationsTerminalEquipment)

General