OSYPKA PACE 203H, Instructions For Use Manual

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PACE 203H – Instructions for Use
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patient. High current amplitudes can
also damage the pacemaker.
13. If PACE 203H is to be used for a
long period of time on a patient, the
stimulation threshold should be
checked from time to time (the first
time after a few hours, then daily),
since an increase of the threshold
may occur.
14. An unnecessarily high sensitivity
(small sensitivity value) increases the
probability that proper pacemaker
functioning will be affected by exter-
nal interference and the device will
switch to asynchronous stimulation
(see also chapter 9.22.3). If there are
strong electromagnetic fields caused
by telecommunication devices (like
mobile phones) or other sources, an
asynchronous mode should be set
with a higher than the patient’s intrin-
sic rate.
15. During dual chamber pacing there is
an inherent potential risk of cross-
stimulation which is a cross-talk of an
atrial stimulation or depolarization
impulse into the ventricle or vice ver-
sa. PACE 203H is designed in such
a way that this cross-talk is mini-
mized. Furthermore, the distance be-
tween atrial and ventricular lead sys-
tem should be not less than 4 cm.
16. Due to differences in the anatomy,
electro-physiological conditions and
the location of the electrodes, cross-
stimulation cannot be completely
prevented. Therefore, when the de-
vice is switched on or when the stim-
ulation parameters are changed, the
user must make sure that no cross-
stimulation occurs. If cross-
stimulation occurs, one can try to
eliminate the effect by adjusting the
stimulation amplitudes or by ex-
changing the polarity of the leads. If
this is not possible, the pacemaker
must, in this special case, be used in
a single-chamber mode without con-
nection of the leads of the other
channel.
17. PACE 203H prevents abnormal set-
tings (see chapter 9.22.7).
18. In order to provide continuous opera-
tion of the pacemaker during battery
changes, the battery must not be left
in the device until it is completely
drained (see also 9.22.1).
19. If the device is switched off or to
stand-by after the request to change
the battery appears, the battery must
be changed before the pacemaker is
turned on again.
20. In case that PACE 203H is not used
for long periods of time, the battery
must be removed in order to prevent
damage from possible battery acid
leakage. (Such damage will not be
compensated under the guarantee).
21. The pacemaker must not be sub-
merged in either water or any other
cleaning solution. Do not use any
scrubbing powder/liquid on the de-
vice.
22. The device must not be sterilized in
an autoclave. Sterilization with plas-
ma, ultrasound or gamma radiation is
also not allowed. PACE 203H can be
damaged by such procedures.
23. Connector cables, intended for single
use, cannot be re-sterilized and rein-
serted into a patient.
24. Only the manufacturer, or facilities
authorized by the manufacturer, can
perform repairs or calibration of
PACE 203H.