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
ExpressionMR400InstructionsforUseGettingStarted3‐3
WhenpositioningtheMR400foruse,observethefollowingwarningandcautions:
Warning
WAR NIN G
.The MR400 shall meet its full function and performance specifications when
positioned in the MR room of a 3T magnet, up to the 5000 gauss line, 4W/kg
SAR, and 7.2 µT B1
rms
in all orientations. Always secure the MR400’s wheel
locks when the unit is placed within the MR system room. Failure to properly
position the MR400 and its accessories in the MR system room will result in
system or accessory failure, and possible patient or user injury.
CAUTIONS
• If the MR400 rolls to the face of the MR system due to magnetically induced pull force, do
not attempt to dislodge the MR400 by pulling from the display panel or guide handle;
instead, dislodge the MR400 by gently pulling from the lowest point of the base. This will
prevent the base of the unit from experiencing higher MR pull forces in the vertical
direction.
• Position the MR400 in a manner which does not block access to the device or wall plug
connectors.
• Field strength variations in a particular MR system room (which may be due to active
shielding technology, manufacturer variability, future enhancements, etc.) can make
distinguishing the 5,000 gauss level (as measured from the center line of the MR bore)
difficult. These variations may require moving the MR400 away from the MR system if
system abnormalities or malfunctions are observed. Prior to clinical use, ensure that the
allowable distance of the MR400 from the MR system is maintained for proper operation.
Operating the MR400
SAFETYAWARENESS
Warning
WAR NIN G
Do not start up the product unless you and all other users present have read, fully
understood and know all the safety information and emergency procedures given in the
Safety section of this Instructions for Use. Operation of the product without having read,
understood and knowing ALL the safety information and procedures in the SAFETY section
could lead to fatal or other serious personal injury. It could also lead to clinical mis-diagnosis
or clinical mistreatment.