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FIAB 4427 Easypace - Use; Possible Complications; Contraindications

FIAB 4427 Easypace
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Cardiac stimulator 4427 Easypace - Instructions for use
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4. USE
Heart stimulator 4427 Easypace is a versatile unit easy to use for single-chamber
temporary intracardiac stimulation. In particular it is recommended in:
extreme bradycardia;
paroxysmal atrial-ventricular block;
interruption of paroxysmal tachycardia from atrial flutter;
atrial-ventricular blocks of various types prior to implantation or replacement of a
definitive pacemaker.
5. POSSIBLE COMPLICATIONS
Complications likely to occur upon using heart stimulator 4427 Easypace are the
following:
muscle stimulation causing contractions and pain;
breaking or displacement of the catheter causing intermittence or lack of stimulation
erroneous setting of stimulation parameters causing capture failure;
erroneous adjustment of the stimulation rate causing induction and tachycardia;
erroneous setting of sense parameters causing the stimulation to loose synchronism or
be inhibited.
5.1. Contraindications
There are no contraindications in relation to the use of 4427 Easypace for temporary
cardiac stimulation during a therapy or arrhythmia prevention. However the Patient's state
of health or the presence of electromagnetic interference can limit the choice of modes
and stimulation parameters.
The stimulator is provided with numerous and redundant safety circuits whose
simultaneous failure - unsigned to the User - is an event very unlikely to occur. However, it
is recommended that the use of the heart stimulator 4427 Easypace be restricted to
authorised medical staff and always accompanied by ECG monitoring.