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The MRI Patient Monitoring System provides monitoring for the following vital sign parameter: oxygen saturation of
SpO
arterial hemoglobin (
Indications for Use
SpO
The
clips and grips are indicated for use with the
2
noninvasive arterial oxygen saturation monitoring, pulse rate monitoring, or pulse triggering is required during MRI
procedures.
13 In the "Monitoring SpO2" chapter, in the "Selecting the Site and Attachment" section, edited text to read as follows:
When applying the clips or grips to the patient, site preparation and the pressure and alignment of the
are important factors to consider. Select the most appropriate limb that best fits the attachment's size. For measurements
to be accurate and reliable, the optimum fit is reached when the fiber head windows of the attachment oppose each other
while covering skin or nail. See the package label for a suggested patient weight range.
14 In the "Monitoring NIBP" chapter introduction, added the following text:
•
The abbreviations NBP and NIBP may be used interchangeably. Both abbreviations mean noninvasive blood
pressure.
•
Reusable NBP cuffs and interconnect hoses are intended for multi-patient use.
•
WARNING: Keep the pressure interconnect hose 6 cm outside the field of view to prevent B0 artifacts.
15 In the "Monitoring NIBP" chapter, added the following sections:
Intended Use
The NBP cuff 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: non-invasive blood
pressure.
Indications for Use
The NBP cuffs are indicated for use when non-invasive blood pressure monitoring of systolic, diastolic, and mean arterial
pressures is required during MRI procedures.
16 In the "Cleaning and Maintenance" chapter, in the "Preventive Maintenance" section, in the "Cleaning, Disinfecting, and
Inspecting the Accessories for Damage" subsection, edited text to read as follows:
During the cleaning process, inspect the accessory for damage. The accessories are exposed to potentially damaging
situations during use and cleaning. Before each use, carefully inspect the accessories and packaging for the signs of
damage listed below.
Device lifetime is considered to end once the device shows signs of damage such as:
• Cracks, holes, tears, gouges, cuts, et cetera.
• Cracks or other signs of damage to the connector, including bent or damaged pins.
• Soil that cannot be removed following the cleaning instructions.
• Disposable accessories must be discarded after each use.
4
).
2
Expression Model MR200 MRI Patient Monitoring System, Instructions for Use Addendum
SpO
sensor and the wireless
2
SpO
module when continuous
2
SpO
attachment
2
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