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23 In "Appendix A: Specifications," in the "Explanation of Symbols" section, added the following
Symbol
YYYY-MM-DD
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.
Expression Model MR200 MRI Patient Monitoring System, Instructions for Use Addendum
Meaning
Packaging Unit
ISO 7000-2794
To indicate the number of pieces in the package. Where a number is inserted
into the symbol to indicate the number of pieces in the package.
Medical Device
European Medical Device Regulation (EU) 2017/745
To indicate that the product is a medical device.
Importer
ISO 7000-3725
To indicate the entity importing the medical device into the locale.
Electronic Instructions for Use
ISO 7000-3500
To indicate that relevant information for use of the product is available in
electronic form in addition to, printed paper form.
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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