User Manual

4. WARNINGS AND PRECAUTIONS
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 (EMI) are: powerful
radiofrequency equipment (radar), industrial motors and transformers, induction furnaces,
resistance, arc-welding equipment and high power loudspeakers.
Be aware that the changes in the patient’s condition, drug regimen, and other factors may
change the defibrillation threshold (DFT) which may result in non-conversion of the
arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular
tachycardia during arrhythmia conversion testing is no assurance that conversion will occur
post-operatively.
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.
Communication equipment:
Communication equipment such as microwave transmitters, linear power amplifiers, or high-
power amateur transmitters may generate enough EMI to interfere with defibrillator
operation if approached too closely.
Home appliances:
Home appliances that are in good working order and properly grounded do not usually
produce enough EMI to interfere with defibrillator operation. There are reports of device
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SORIN – INTENSIA SonR CRT-D 184 – U150A