User's Manual

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 disturbance are: powerful radiofrequency equipment
(radar), industrial motors and transformers, induction furnaces, resistance welding/ arc-
welding equipment and high power loudspeakers.
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.
Electronic Article Surveillance (EAS) and RadioFrequency IDentification
equipment (RFID)
Patients should be advised to walk directly through and not lean against or linger near
Electronic Article Surveillance (EAS) systems such as retail theft prevention systems,
security gates, entry control systems, or tag readers including Radio Frequency
IDentification equipment (RFID). These systems may be found at the entrances and exits of
stores, libraries, banks, etc...and may interact with pulse generators. It is unlikely that these
systems affect cardiac function when the patient walks through them at a normal pace. If
patients do experience symptoms near these systems, they should promptly move away and
inform their doctor.
Work environment:
The patient's work environment may be an important source of disturbance. In that case,
specific recommendations may be required.
High voltage power transmission lines:
High voltage power transmission lines may generate enough disturbance 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 disturbance 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 disturbance to interfere with defibrillator operation. However, there are
reports of device interferences caused by electric hand tools or electric razors used directly
over the device implant site. Patient should also avoid using induction ovens and cookers.
4. WARNINGS AND PRECAUTIONS
SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 11