OSYPKA PACE 203H, Instructions For Use Manual

Page: 17 / 139

PACE 203H – Instructions for Use
5I-17-016X-B-20 17 / 139
6 Precautionary Measures
and Warnings
The following list presents important
precautionary measures and warnings.
Additional important precautionary
measures and warnings will be found in
the following chapters.
1. In order to prevent unnecessary
complications, PACE 203H should
only be applied and used by medical
personnel with extensive experience
in cardiac stimulation therapy. Addi-
tionally, the person using the device
should be thoroughly familiar with the
contents of this instruction manual.
2. All lead systems are to be connected
to type CF devices only, because of
the danger of current being diverted
to the heart. Devices that are con-
nected to a main supply pose in-
creased danger for current diversions
to the heart.
3. Make sure that all devices in the
vicinity of the patient are properly
grounded.
4. The stimulation leads provide a di-
rect, low-resistance current path to
the heart. Therefore, it is absolutely
necessary that the connector plug is
not touched with bare hands or come
in contact with electrically conductive
or wet surfaces. All possible static
electricity sources must be kept away
from the stimulation system.
5. While the lead is being inserted and
connected to the pacemaker, contin-
uous ECG monitoring is mandatory.
For emergency situations, a defibril-
lator should always be available in a
ready-to-use state.
6. ECG monitoring should be continued
during all times PACE 203H is in use
to signal possible complications of
different reasons immediately to the
medical staff.
7. In either case it is necessary to moni-
tor the patient and to be prepared for
a failure of the pacemaker function. A
back-up device for the pacemaker
must be available.
8. Error messages and conflict warn-
ings of PACE 203H do not replace
an ECG monitoring.
9. During atrial overdrive-stimulation an
accidental conduction into the ventri-
cle is possible and may cause ven-
tricular tachycardia. Therefore, con-
tinuous ECG-monitoring is mandato-
ry. A defibrillator should always be
available in a ready-to-use state.
10. If PACE 203H operates in an asyn-
chronous mode, the pacing pulses
may occur during the vulnerable
phase of the patient’s intrinsic activity
(corresponds approximately in the
ECG to the T-wave); and may cause
ventricular fibrillation and ventricular
flutter.
11. It is mandatory to continuously moni-
tor the patient and to be prepared for
a possible failure or malfunctioning of
the pacemaker when PACE 203H is
used in conjunction with electro-
surgical instruments or defibrillators.
12. To protect the patient and the pace-
maker from current passing through
the pacemaker/lead-circuitry caused
by defibrillation discharges, the stim-
ulation circuit should always be
opened during defibrillation if possi-
ble. Current flows caused by defibril-
lator discharges can endanger the