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: Electrocardiograph (ECG)
Indications for Use
The ECG cables are indicated for use with the ECG electrodes and the wireless ECG module when continuous
electrocardiograph (ECG) monitoring or cardiac gating is required during MRI procedures.
The ECG electrodes are indicated for use with the ECG cable and wireless ECG module when continuous
electrocardiograph (ECG) monitoring or cardiac gating is required during MRI procedures.
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10 In the "Monitoring
Intended Use
SpO
The
clips and grips use enables the Intended Use of the connected compatible MRI Patient Monitoring System.
2
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: oxygen saturation of
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arterial hemoglobin (
Indications for Use
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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.
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11 In the "Monitoring
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.
12 In the "Monitoring NIBP" chapter introduction, added the following text:
•
The abbreviations NBP and NIBP both 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.
13 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.
Expression Model MR400 MRI Patient Monitoring System, Instructions for Use Addendum
" chapter, added the following sections:
2
).
2
" chapter, in the "Selecting the Site and
2
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sensor and the wireless
2
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Attachment" section, edited text to read as follows:
2
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module when continuous
2
SpO
attachment
2
3
