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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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In the "Monitoring ECG" chapter, in the "wECG Module and Lead Cable" section, edited text to read as follows:
The wECG module and lead cable are intended for patient use when continuous ECG monitoring or cardiac gating are
required. The wECG module and lead cable may be used in the MR system bore, although the module must be kept at
least 5.5 inches (14 cm) outside of the MRI field of view (FOV) to prevent image artifacts.
10 In the "Monitoring ECG" chapter, in the "Attaching the Lead Cable" section, edited text to read as follows:
Edited the caution in step 1 to read as follows:
When inserting or removing the lead cable or clip leads, only use the connector or clip; never pull or apply excessive
force to the wires. Otherwise, damage may occur.
Edited text in step 3 to read as follows:
Keep the module at least 5.5 inches (14 cm) outside the field of view by placing it in one of the two locations shown in
Positioning the wECG Module and Lead Cable for Scanning...
11 In the "Monitoring ECG" chapter, in the "Positioning the wECG Module and Lead Cable for Scanning" section, edited text
to read as follows:
The wECG module may be used in the MR system bore, although the module must be kept at least 5.5 inches (14 cm)
outside the MRI field of view.
NOTE: Follow these guidelines to ensure the best possible performance of the wECG module, especially during harsh
scan sequences (with PNS-peripheral nerve stimulation-levels above 80 percent):
1. Place the modules on or near the patient as close to the bore iso-center as possible (considering the scan to be
performed).
2. Keep the wireless module at least 5.5 inches (14 cm) outside the field of view.
3. Place the modules as close to the bore opening as possible. (If the modules can be placed outside the bore,
positioning at the bore iso-center is not necessary.)
4. Place the modules on a cushioned surface to minimize MR vibrations.
In the same section, added the following warning:
WARNING: Keep the wECG module at least 5.5 inches (14 cm) outside the MRI field of view. If the wECG module is
placed too close to the field of view, the MRI images could contain B0 artifacts, leading to possible misdiagnosis.
12 In the "Monitoring SpO2" chapter, added the following sections:
Intended Use
SpO
The
clips and grips use enables the Intended Use of the connected compatible MRI Patient Monitoring System.
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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 MR200 MRI Patient Monitoring System, Instructions for Use Addendum
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