User Manual

4. WARNINGS AND PRECAUTIONS
disturbances caused by electric hand tools or electric razors used directly over the device
implant site.
4.1. RISKS RELATED TO MEDICAL ENVIRONMENT
It is advisable to carefully monitor defibrillator operation prior to and after any medical
treatment during which an electrical current from an external source passes through the
patient's body.
Magnetic Resonance Imaging:
MRI is strictly contraindicated in cardiac defibrillator patients.
Radiofrequency ablation:
A radiofrequency ablation procedure in a patient with a generator may cause device
malfunction or damage. RF ablation risks may be minimized by:
1. Programming Shock Therapy and ATP to OFF.
2. Avoiding direct contact between the ablation catheter and the implanted lead or generator.
3. Positioning the ground, placing it so that the current pathway does not pass through or
near the device, i.e. place the ground plate under the patient’s buttocks or legs.
4. Having external defibrillation equipment available.
Electrocautery or diathermy device:
Diathermy and electrocautery equipment should not be used. If such devices must be used:
1. Keep the current path and ground plate as far away from the device and the leads as
possible (a minimum of 15 cm [six inches]).
2. Before procedure, disable ATP and shock therapies.
3. During the procedure, keep the electrocautery device as far as possible from the cardiac
defibrillator. Set it at minimum intensity. Use it briefly.
4. After the procedure, check for proper implant function. The device should never be
exposed directly to the diathermy source.
External defibrillation:
INTENSIA CRT-D 174 is protected from external defibrillation shocks.
1. Before external defibrillation, disable ATP and shock therapies.
2. During external defibrillation, it is advisable to avoid placing the defibrillating paddles
directly over the casing or over the leads. The defibrillating paddles should preferably be
placed in an anteroposterior position.
3. Avoid any direct contact between the defibrillation paddles and the conductive parts of the
implanted leads or casing of the implanted device.
4. After external defibrillation, check for proper device function.
Radiation therapy:
Avoid exposure to ionizing radiation. Betatrons are contraindicated. If high doses of radiation
therapy cannot be avoided, the defibrillator should be protected from direct exposure with a
SORIN – INTENSIA CRT-D 174 – U151A
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CAUTION: Do not tap sharply on the ICD can after implant, because the ICD's sensing
circuits can detect this as P-waves or R-waves, and such oversensing could result in
inappropriate pacing, inhibition, or therapy. Normal activities after implant do not result in
such oversensing.