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24 In "Appendix C: Gating Feature," added the following:
WARNING: To prevent patient injury, ensure the Universal Gating Interface is not on the patient table during imaging.
Intended Use
The Universal Gating Interface use enables the Intended Use of the connected compatible MRI Patient Monitoring
System.
The MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to
provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System is intended for use by
healthcare professionals.
The MRI Patient Monitoring System provides monitoring for the following vital sign parameter: ECG or SpO2.
Indications for Use
The Universal Gating Interface, which connects the patient monitor to the MRI system, is indicated for use when low
latency MRI triggering and synchronization is needed during MRI procedures based on the measured cardiac physiology
signal.
Connecting the Universal Gating Interface
When using the Universal Gating Interface to perform gating through an indirect, wired connection, connect the triggering
lead wires from the MR system to the connector box. Ensure you match the colors as shown on the box. Connect the
interface cable to the cardiac gating output connection port on the rear panel of the cart.
25 Throughout the instructions for use:
•
All references to "Radio & Telecommunications Terminal Equipment Directive (1999/5/EC)" have been replaced with
"Radio Equipment Directive (2014/53/EU)."
Expression Model MR400 MRI Patient Monitoring System, Instructions for Use Addendum
Meaning
Unique Device Identifier
21CFR 801 Subpart B
European Medical Device Regulation (EU) 2017/745
Indicates the UDI information on the label.
Mass; weight
ISO 7000-1321A
To indicate mass. To identify a function related to mass.
Assortment
ISO 7000-2791
To identify that the package includes an assortment of types or sizes.
IEC 60417-6049: Country of manufacture
To identify the country of manufacture of products.
In the application of this symbol, the "CC" shall be replaced by either the two
letter country code or the three letter country code defined in ISO 3166-1.
Name of manufacturer and date of manufacture may be added adjacent to this
symbol.
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