User's Manual

US-ENGLISH – 7
4. WARNINGS AND PRECAUTIONS
The patient should be warned of the potential risks of defibrillator
malfunction if he is exposed to external magnetic, electrical, or
electromagnetic signals.
These potential interference sources may cause conversion to
inhibited mode (because of noise detection), erratic delivery of VT or
VF therapies, nominal programming, or much more rarely,
irreversible damage to the device’s circuits.
The main sources of high magnitude electromagnetic interference
are: powerful radiofrequency equipment (radar), industrial motors
and transformers, arc-welding equipment, high power loudspeakers.
Resuscitation Availability: Do not perform device testing unless an
external defibrillator and medical personnel skilled in
cardiopulmonary resuscitation (CPR) are readily available.
Electrical Isolation: Do not permit the patient to contact grounded
equipment that could produce hazardous leakage current. Ensuing
arrhythmia induction could result in the patient’s death.
Disable the ICD During Handling: Program Shock Therapy to OFF
during surgical implant and explant or post mortem procedures. The
device can deliver a serious high energy shock should accidental
contact be made with the defibrillation electrodes.
Antitheft gates: Since antitheft devices at the entrance to stores are
not subject to any safety standards, it is advisable to spend as little
time as possible in their vicinity.
Airport detection systems: Since airport detection systems are not
subject to any safety standards, it is advisable to spend as little time
as possible in their vicinity.
High voltage power transmission lines: High voltage power
transmission lines may generate enough EMI to interfere with
defibrillator operation if approached too closely.