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‐10Specifications ExpressionMR400InstructionsforUse
When“HR”isderivedfromSPO2
Lower
Upper
Off,or30to250BPM
60to250BPM,oroff
Note
Measurement validation: SPO2 accuracy validated in human studies against arterial blood sample reference measured with
a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70–100 percent
SPO2 were studied. The population characteristics for those studies were:
• about 50% female and 50% male subjects
• 19 – 27 years of age
• light to black skin tones
Reference method for the computation of pulse rate accuracy made using an electronic pulse simulator. (A functional
tester cannot be used for accuracy assessment of a pulse oximeter monitor; however, it can demonstrate that a pulse
oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular
accuracy specification.)
SPO2 measurements are statistically distributed; therefore, in accordance to 80601-2-61:2011, it is possible that only
two-thirds of the measurements will fall within ± 3 percent of the value measured by the CO-Oximeter.
CO2 (Optional LoFlo)
Sidestream,non‐dispersiveinfraredabsorptiontechnique,includesmultiplefiltrationsystemandmicroprocessor
logiccontrolofsamplehandlingandcalibration.Methodfordeterminingend‐tidalCO2measurement:Measures
peakoftheend‐tidalCO2waveformevery20seconds.
Output CO2waveform,EtCO2
andFiCO2
measurementnumericvalues,
andrespirationrate
InitializationTime Waveformdisplayedinlessthan20seconds,atanambient
temperatureof25°C(77°F);fullspecificationsattainedwithin2
minutes
ZeroCalibrationInterval Automaticoruserrequested
CO2UnitofMeasure Millimetersofmercury(mmHg)orkilopascals*(kPa)
CO2Resolution 1mmHg(0.1kPa)
FlowRate 50mL/minute±10
mL/minute
DataSampleRate 100Hz
End‐tidalCO2(EtCO2)MeasurementRange
(InwhichtheCO2accuracyspecificationismet)
0to76mmHg(0to10.1kPa)forrespiration ratesrangingfrom4
to60breathsperminute,inclusive
Pulse Oximeter