USER INSTRUCTION MANUAL
Page 2 of 49 ENGLISH
1.1.6 Contraindications
Do not use the Stimulator system for life support in patients with life-threatening bradycardia; use
instead temporary external pacemaker.
1.2 Compatible Equipment
The primary function of the Micropace Cardiac Stimulator is the generation of constant current
rectangular stimulation pulses with amplitudes of 0.1mA to 25mA, duration of 0.5ms to 10ms and with
a maximum voltage of ± 27V. Third party switching equipment with the following special characteristics
must be used to carry the stimulus pulses to the intracardiac electrodes without significant distortion:
Series resistance: < 100 Ohms at up to ± 25mA
Shunt resistance: > 100,000 Ohms at up to ± 27V
Frequency bandwidth: DC to 300 Hz
Interference RF energy sources: < 350Vpp at 400 kHz to 600 kHz, or 150W into a 300 Ohm
load
Micropace Stimulator is intended for use with the following equipment;
Diagnostic and Ablation pacing electrode catheters
Currently available legally marketed electrophysiological diagnostic electrode catheters,
including those manufactured by Cordis Biosense Webster, Daig, CR Bard, Medtronic and
EPT.
EP Recording equipment
Computerized EP Recording systems manufactured by Bard Electrophysiology (LabSystem
TM
Duo
TM
and LS Pro
TM
) and GE/Prucka (CardioLab 4000, 7000) have been tested for use with
the EPS320 Stimulator.
1.3 Important Patient Safety Warnings
1.3.1 General Warning
Warning: Stimulator must be used only under supervision by a cardiologist.
To avoid death or injury to patient from arrhythmias, the Stimulator may be used on humans
only under the direct supervision by a physician familiar with electrophysiology in an
appropriate hospital facility.
The supervising physician must verify all Stimulator settings immediately prior to
commencement of pacing.
Warning: Installation and use only by qualified personnel.
Only qualified personnel, such as representatives of Micropace Pty Ltd, its authorized
distributor or hospital-appointed biomedical engineers, may carry out installation of the
Stimulator system and its connection to other equipment.
In order to reduce operator errors, installation, configuration and customer training should be
performed in a manner, which allows optimal use of the Stimulator by the user.
Warning: Stimulator is not a life support device – operator must have available backup
temporary external pacemaker.
To avoid injury to patient from bradycardia, operator must have available a backup temporary
external pacemaker.
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