Rev. 3.1 5.ECG 119
BM5 (CS,CX) User’s Manual
CAUTION
FDA POSTMARKET SAFETY ALERT
The United States FDA Center for Device 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
programmed rate.”
The FDA further recommends precautions to take into consideration for patients with these
types of pacemakers. These precaution 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 Packard Drive, Mail Stop HFZ-510 Rockville, MD 20850 U.S.A
NOTE
ECG monitoring with patients in non-invasive trans coetaneous pacemakers may not be possible
due to large amounts of energy produced by these devices. Monitoring ECG with an external device
may be needed.
WARNINGS
VENTRICULAR ARRHYTHMISAS
The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to
detect a trial or supra ventricular arrhythmias. Occasionally it may incorrect identify the presence or
absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information in
conjunction with other clinical findings.
SUSPENDED ANALYSIS
Certain conditions suspend arrhythmia analysis. When suspended, arrhythmia conditions
are not detected and alarms associated with arrhythmias do not occur. The messages
which alert you to the conditions causing suspended arrhythmia analysis are : ARR OFF,
ARRHYSUSPEND, LEADS FAIL, ALARM PAUSE, ALL ALARMS OFF, and DISCHARGED.
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