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Electromagnetic interference (EMI)
Any device can be sensitive to interference if external signals are sensed as intrinsic
rhythm or if measurements prevent rate adaptation.
• BIOTRONIK devices have been designed so that their susceptibility to EMI is
minimal.
• Due to the intensity and variety of EMI, there is no guarantee for safety. It is
generally assumed that EMI produces only minor symptoms, if any, in patients.
• Depending on the pacing mode and the type of interference, sources of interference
may lead to pulse inhibition or triggering, an increase in the sensor-dependent
pacing rate or asynchronous pacing.
• Under unfavorable conditions, for example during therapeutic or diagnostic proce-
dures, interference sources may induce such a high level of energy into the pacing
system that the cardiac tissue surrounding the lead tip is damaged.
Device behavior in case of EMI
In case of electromagnetic interference, the device switches to asynchronous pacing
for as long as the interference rate is exceeded.
Static magnetic fields
The reed switch in the device closes starting at a field strength of 1.8 mT. The reed
switch opens if the magnetic field falls below 1 mT.
Possible Risks
Contraindicated procedures
The following procedures are contraindicated as they may cause harm to the patient or
damage the device and, as a result, put the system functionality at risk:
• Therapeutic ultrasound: Harm to the patient via excess warming of body tissue
near the device system
• Transcutaneous electrical nerve stimulation
• Hyperbaric oxygen therapy
• Applied pressures higher than normal pressure
Risky therapeutic and diagnostic procedures
If electrical current from an external source is conducted through the body for diag-
nostic or therapeutic purposes, then the device can be subjected to interference, which
can place the patient at risk.
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Arrhythmia or ventricular fibrillation can be induced during diathermic procedures
such as electrocautery, HF ablation or HF surgery. For example, damaging heat can
result during lithotripsy. Influences on the device are not always immediately clear.
If risky procedures cannot be avoided, the following should be observed at all times:
• Electrically insulate the patient.
• Switch off the ICD's detection function. The pacemaker function can remain active.
The device may need to be switched to asynchronous modes for this.
• Do not introduce energy near the device system.
• Additionally check the peripheral pulse of the patient.
• Monitor the patient during and after every intervention.
External defibrillation
The device is protected against the energy that is normally induced by external defibril-
lation. Nevertheless, any implanted device may be damaged by external defibrillation.
Specifically, the current induced in the implanted leads may result in necrotic tissue
formation close to the electrode/tissue interface. As a result, sensing properties and
pacing thresholds may change.
• Place adhesive electrodes anterior-posterior or perpendicular to the axis formed
by the device to the heart at least 10 cm away from the device and from implanted
leads.
Radiation therapy
The use of radiation therapy is contraindicated due to possible damage to the device
and the resulting impaired functional safety. If this type of therapy is to be used anyway,
prior risk/benefit analysis is absolutely necessary. The complexity of influencing
factors such as different sources of radiation, a variety of devices and therapy condi-
tions makes it impossible to issue directives that guarantee radiation therapy without
an impact on the device. The EN 45502 standard pertaining to active implantable
medical devices requires the following measures during the administration of thera-
peutic ionizing radiation:
• Adhere to instructions for risky therapy and diagnosis procedures.
• Shield device against radiation.
• After applying radiation, double-check the device system to make sure it is func-
tioning properly.
Note: Please contact BIOTRONIK with questions during the risk/benefit analysis.
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