CARDIAC STIMULATOR
ENGLISH Page 3 of 49
Warning: Stimulator must use isolated mains supply only.
To avoid electrocution hazards, all parts of the Stimulator, including the computer, monitor and
Stimulus Generator Unit must all be connected to the Mains Isolation Transformer and never
directly to a mains power outlet.
Warning: To avoid electrocution hazards, connect Stimulator system only to legally marketed,
mains-isolated electrical equipment.
Connect Stimulator only to parts specified by Micropace as compatible or to equipment
certified to IEC 60601-1.
Do not connect equipment other than that specified by Micropace to the multiple socket outlets
on the Micropace supplied Isolation Transformer.
If this equipment is modified, appropriate inspection and testing, including IEC 60601-1:2005,
must be conducted to ensure continued safe use of the equipment.
Avoid connecting equipment parts to patient by touching simultaneously conductive part of this
or other equipment and the patient.
Warning: Use Stimulator only in ventilated areas and away from flammable gasses.
To avoid risk of explosion, the Stimulator should only be used in a ventilated area as gasses
may be released during charging of backup battery, and should not be used in rooms with
flammable anesthesia.
1.3.2 Warnings Specific to the Micropace Stimulator
Warning: Monitor function of Stimulator and patient’s vital signs continuously.
The Micropace Stimulator may fail to stimulate or unintentionally stimulate the patient through
software, hardware or human error. To avoid injury to patient from arrhythmias, monitor the
function of Stimulator and patient’s vital signs continuously while Stimulator is connected to
the patient.
In case of repeated recurrence of unexplained life-threatening arrhythmias despite
cardioversion/defibrillation during the use of the Stimulator, disconnect the Stimulator from the
patient by unplugging the green Pace Output plug on the front panel in case it has an occult
malfunction causing recurrent micro-electrocution or recurrent DC current stimulation.
Warning: Measurements by Stimulator are for information only.
Measurements displayed by Stimulator, including the Impedance measurement, RR interval
and SNRT measurement are for facilitation of use of Stimulator. The user should use third
party legally marketed measurement devices independent of the Stimulator to measure these
parameters for the purpose of clinical diagnoses.
Warning: When using the optional Four Channel Stimulus Multiplexer Box (SM-Box)
Product is not suitable for sterilization and must be protected from ingress of fluids
In order to prevent inadvertent or ineffective pacing, the user should always verify the actual
channel being paced using independent EP Recording Equipment.
1.3.3 Warnings Related to the use of Micropace Stimulator with RF Ablation
Equipment
Warning: Use Stimulator only with RF-filtered stimulus connection. (Micropace parts: MP3014,
MP3086).
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