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‐26Specifications ExpressionMR400InstructionsforUse
Notes
• The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion
criteria.
• The NIBP clinical study was performed on adult and pediatric patients with the following attributes:
– The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the
exclusion criteria.Gender: 61% male, 39% female.
– No patients less than 29 days of age.
– Patients with limb circumferences ranged from 10.5 cm to 39 cm, with a distribution of 46 percent below
25 cm and 7 percent above 35 cm.
– The arterial systolic pressure ranges from 58 mmHg to 211 mmHg, with an average of 115 mmHg and with
a distribution of 32.7 percent below 100 mmHg and 2.4 percent above 180 mmHg. The arterial diastolic
pressure ranges from 34 mmHg to 131 mmHg, with an average of 65 mmHg and with a distribution of 42.3
percent below 60 mmHg and 3.9 percent above 100 mmHg.
– Patients with any sign of arterial disease were excluded.
– Patients with a heart beat greater than 180 BPM were excluded.
– The radial artery was acceptable as a reference site for all patients but one which used the femoral artery.
– The effectiveness was not validated on pregnant, including pre-eclamptic, patient populations.
• The NIBP clinical study was performed on neonatal patients with the following attributes:
– No specified gender.
– All patients 28 days or less if born at term (37 gestation or more); otherwise, up to 44 gestational weeks.
– Patients with limb circumferences ranged from 5.75 cm to 13 cm with an average of 7.9 cm.
– The arterial systolic pressure ranged from 42 mmHg to 89 mmHg, with an average of 57 mmHg. The
arterial diastolic pressure ranged from 20 mmHg to 62 mmHg, with an average of 34 mmHg.
• Arterial reference sites included the umbilical, femoral, brachial and radial artery.
Non-Invasive Blood Pressure