Operator's Manual Part 2

11-18 ApexPro Telemetry System Revision D
2001989-134
ECG Monitoring: ECG Tab Sheet
CAUTION
FDA POSTMARKET SAFETY ALERT—The United
States FDA Center for Devices and Radiological Health
issued a safety bulletin October 14, 1998. This bulletin
states “that minute ventilation rate-adaptive
implantable pacemakers can occasionally interact with
certain cardiac monitoring and diagnostic equipment,
causing the pacemakers to pace at their maximum
programmed rate.”
The FDA further recommends precautions to take into
consideration for patients with these types of
pacemakers. These precautions include disabling the rate
responsive mode and enabling an alternate pace mode.
For more information contact:
Office of Surveillance and Biometrics, CDRH, FDA
1350 Piccard Drive, Mail Stop HFZ-510
Rockville, MD 20850
U.S.A.
NOTE
ECG monitoring with patients on non-invasive transcutaneous
pacemakers may not be possible due to large amounts of energy
produced by these devices. Monitoring ECG with an external device
may be needed.