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Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
PAGE 7
4. Warnings and Precautions
Certain therapeutic and diagnostic procedures may cause undetected damage to a pulse generator,
resulting in malfunction or failure at a later time. Please note the following warnings and precautions:
Magnetic Resonance Imaging (MRI) Avoid use of magnetic resonance imaging as it has been
shown to cause movement of the pulse generator within the subcutaneous pocket and may cause pain
and injury to the patient and damage to the pulse generator. If the procedure must be used, constant
monitoring is recommended, including monitoring the peripheral pulse.
Rate-Adaptive Pacing Use rate-adaptive pacing with care in patients unable to tolerate increased
pacing rates.
High Output Settings
High output settings combined with extremely low lead impedance may reduce
the life expectancy of the pulse generator to less than 1 year. Programming of pulse amplitudes, higher
than 4.8 V, in combination with long pulse widths and/or high pacing rates may lead to premature
activation of the replacement indicator.
4.1 Medical Therapy
Before applying one of the following procedures, a detailed analysis of the advantages and risks
should be made. Cardiac activity during one of these procedures should be confirmed by continuous
monitoring of peripheral pulse or blood pressure. Following the procedures, pulse generator function
and stimulation threshold must be checked.
Therapeutic Diathermy Equipment Use of therapeutic diathermy equipment is to be avoided for
pacemaker patients due to possible heating effects of the pulse generator and at the implant site.
If diathermy therapy must be used, it should not be applied in the immediate vicinity of the pulse
generator/lead. The patient’s peripheral pulse should be monitored continuously during the treatment.
Transcutaneous Electrical Nerve Stimulation (TENS)
Transcutaneous electrical nerve stimulation
may interfere with pulse generator function. If necessary, the following measures may reduce the
possibility of interference:
• Place the TENS electrodes as close to each other as possible.
• Place the TENS electrodes as far from the pulse generator/lead system as possible.
• Monitor cardiac activity during TENS use.
Defibrillation The following precautions are recommended to minimize the inherent risk of pulse
generator operation being adversely affected by defibrillation:
• The paddles should be placed anterior-posterior or along a line perpendicular to the axis formed by
the pulse generator and the implanted lead.
• The energy setting should not be higher than required to achieve defibrillation.
• The distance between the paddles and the pacer/electrode(s) should not be less than 10 cm
(4 inches).
Radiation Pulse generator electronics may be damaged by exposure to radiation during radiotherapy.
To minimize this risk when using such therapy, the pulse generator should be protected with local
radiation shielding.
Lithotripsy Lithotripsy treatment should be avoided for pacemaker patients since electrical and/
or mechanical interference with the pulse generator is possible. If this procedure must be used, the
greatest possible distance from the point of electrical and mechanical strain should be chosen in order
to minimize a potential interference with the pulse generator.