User Manual

Magnetic Resonance Imaging:
When implanted in combination with MR Conditional lead(s), the pacing system constitutes
an MR conditional system under specific conditions.
When these conditions are not met, MRI is contraindicated.
NOTE: Refer to the MRI Solutions manual for the complete instructions for use available at
www.microportmanuals.com.
Mechanical ventilators:
Mechanical ventilators may cause pacing rate changes. Program the pacemaker to a non-
rate responsive mode during ventilation.
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. Avoiding direct contact between the ablation catheter and the implanted lead or
generator.
2. 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.
3. 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. During the procedure, keep the electrocautery device as far as possible from the
pacemaker. Set it at minimum intensity.
3. 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:
If the patient must be defibrillated, it is recommended 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.
Any direct contact between the defibrillation paddles and the conductive parts of the
implanted leads or casing of the implanted device may damage the pacing system.
After external defibrillation, check for proper device function.
Internal defibrillator:
Use of the pacemaker is contraindicated in patients implanted with defibrillator.
Radiation therapy:
Avoid exposure to ionizing radiation. Betatrons are contraindicated. If high doses of
radiotherapy cannot be avoided, the pacemaker should be protected from direct exposure
with a protection shield, and pacemaker operation should be monitored continuously.
4. WARNINGS
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