User Manual

ManualsBrandsInvivo ManualsElectronicsWireless SpO2 for Patient Monitoring in MRI Environments

401

402

403

404

405

406

407

408

409

410

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

E‐2GuidelinesandReferencesExpressionMR400InstructionsforUse

1. PreparethepatientfortheMRprocedurebyensuringthattherearenounnecessary

metallicobjectscontactingthepatient'sskin(e.g.,metallicdrugdeliverypatches,jewelry,

necklaces,bracelets,keychains,etcetera).

2. PreparethepatientfortheMRprocedurebyusing

insulationmaterial(i.e.,appropriate

padding)topreventskin‐to‐skincontactpointsandtheformationof“closed‐loops”from

touchingbodyparts.

3. Insulatingmaterial(minimumrecommendedthickness,1cm)shouldbeplacedbetween

thepatient'sskinandtransmitRFcoilthatisusedfortheMRprocedure(alternatively,the

RFcoil

itselfshouldbepadded).Forexample,positionthepatientsothatthereisnodirect

contactbetweenthepatient'sskinandthebodyRFcoiloftheMRsystem.Thismaybe

accomplishedbyhavingthepatientplacehis/herarmsoverhis/herheadorbyusingelbow

padsorfoampadding

betweenthepatient'stissueandthebodyRFcoiloftheMRsystem.

ThisisespeciallyimportantforthoseMRexaminationsthatusethebodycoilorotherlarge

RFcoilsfortransmissionofRFenergy.

4. Useonlyelectricallyconductivedevices,equipment,accessories(e.g.,ECGleads,

electrodes,etcetera),and

materialsthathavebeenthoroughlytestedanddeterminedto

besafeandcompatibleforMRprocedures,aslistedinthisIFU.

5. CarefullyfollowspecificMRsafetycriteriaandrecommendationsforimplantsmadefrom

electrically‐conductivematerials(e.g.,bonefusionstimulators,neurostimulationsystems,

etcetera).

6. Beforeusing electricalequipment,checktheintegrity

oftheinsulationand/orhousingof

allcomponentsincludingsurfaceRFcoils,monitoringleads,cables,and wires.Preventive

maintenanceshouldbepracticedroutinelyforsuchequipment.

7. Removeallnon‐essentialelectricallyconductivematerialsfromtheMRsystem(i.e.,

unusedsurfaceRFcoils,ECGleads,cables,wires,etcetera).

8. Keepelectricallyconductive

materialsthatmustremainintheMRsystemfromdirectly

contactingthepatientbyplacingthermaland/orelectricalinsul ation betweenthe

conductivematerialandthepatient.

9. KeepelectricallyconductivematerialsthatmustremainwithinthebodyRFcoilorother

transmitRFcoiloftheMRsystemfromformingconductiveloops.

Note:Thepatient's

tissueisconductiveand,therefore,maybeinvolvedintheformationofaconductiveloop,

whichcanbecircular,U‐shaped,orS‐shaped.

10. Positionelectricallyconductivematerialstoprevent“crosspoints”.Forexample,across

pointisthepointwhereacablecrossesanothercabl e,wherea

cableloopsacrossitself,or

whereacabletoucheseitherthepatientorsidesofthetransmitRFcoilmorethanonce.

Notably,eventhecloseproximityofconductivematerialswitheachothershouldbe

avoidedbecausesomecablesandRFcoilscancapacitively‐couple(withoutanycontactor

crossover)when

placedclosetogether.

11. PositionelectricallyconductivematerialstoexitdownthecenteroftheMRsystem(i.e.,

notalongthesideoftheMRsystemorclosetothebodyRFcoilorothertransmitRFcoil).