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5 Implantable Device Safety
WARNING
CT SCANS MAY CAUSE INTERFERENCE WITH IMPLANTED OR
EXTERNALLY WORN ELECTRONIC MEDICAL DEVICES SUCH AS
PACEMAKERS, DEFIBRILLATORS, NEUROSTIMULATORS AND DRUG
INFUSION PUMPS. THE INTERFERENCE COULD CAUSE OPERATIONAL
CHANGES OR MALFUNCTION OF THE ELECTRONIC MEDICAL DEVICE.
5.1 Recommendations prior to scanning
•
If practical, try to move external devices out of the scan range.
•
Ask patients with neurostimulators to shut off the device temporarily while the scan is
performed.
•
Minimize the X-ray exposure to the electronic medical device.
•
Use the lowest possible X-ray tube current consistent with obtaining the required image
quality.
•
Do not scan directly over the electronic device for more than a few seconds.
NOTE:
For procedures such as CT Perfusion or CT Interventional scans that require
scanning over the electronic medical device for more than a few seconds,
attending staff should be ready to take emergency measures to treat adverse
reactions if they occur.
5.2 Recommendations after scanning
•
Have the patient turn the device back on if it had been turned off prior to scanning.
•
Have the patient check the device for proper functioning, even if the device was turned off.
•
Advise the patient to contact his or her healthcare provider as soon as possible if the patient
suspects their device is not functioning properly after a CT scan.
NOTE:
Recommendations from FDA Preliminary Public Health Notification: Possible
Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT)
Scanning date July 14, 2008.
WARNING
THIS SYSTEM IS INTENDED FOR USE BY HEALTHCARE PROFESSIONALS
ONLY. THIS SYSTEM MAY CAUSE RADIO INTERFERENCE OR MAY
DISRUPT THE OPERATION OF NEARBY EQUIPMENT. IT MAY BE
NECESSARY TO TAKE MITIGATION MEASURES, SUCH AS REORIENTING
OR RELOCATING THE SYSTEM OR SHIELDING THE LOCATION.
Revolution CT User Manual
Direction 5480385-1EN, Revision 1
64
5 Implantable Device Safety