2
!
WARNING
EP-4 function is not guaranteed to be uninterrupted or
error free.
St. Jude Medical offers several programs that warrant the EP-
4 to operate according to specification however there is no
guarantee that the device will do so in all circumstances, over
an indefinite period of time. Should the EP-4 begin to operate
outside of its specifications it could potentially fail to
stimulate or unintentionally stimulate the patient; to avoid
injury to the patient the EP-4 and the patient must be
observed for abnormal function of the device at all times while
connected to the patient.
In case of recurrent or persistent unexplained life-threatening
ventricular tachycardia or ventricular fibrillation occurring
despite cardioversion/defibrillation during the use of the EP-
4, disconnect the patient from the device and all other
equipment. If micro-electrocution or recurrent DC current
stimulation are detected, immediately disconnect patient at
the intra-cardiac electrode catheter connectors on the front
panel of the device.
!
WARNING
Do not stimulate any output channel connected directly
to another device delivering energy to the patient.
To avoid possibility of unintended arrhythmia induction, do
not stimulate the heart via a catheter during direct application
of RF energy, internal cardioversion, electrocautery, or any
other energy source on the stimulating output channel.
Efficacy and potential for adverse effects during stimulation
while connected to other energy radiating devices have not
been established.
