User Manual

13 General Safety Instructions 
Possible Risks
Possible Risks
Procedures to avoid The following procedures must be avoided as they may cause harm to the patient or
damage the device and, as a result, put the system functionality at risk:
• Therapeutic ultrasound
• Transcutaneous electrical nerve stimulation
• Hyperbaric oxygen therapy
• Applied pressures higher than normal pressure
Potentially risky therapeutic
and diagnostic procedures
If electrical current from an external source is conducted through the body for
diagnostic or therapeutic purposes, then the device can be subjected to
interference and the patient placed at risk.
Arrhythmia or ventricular fibrillation can be induced during diathermic procedures
such as electrocautery, HF ablation or HF surgery. For example, damaging
pressure levels may arise during lithotripsy. Influences on the device are not always
immediately clear.
If potentially risky procedures cannot be avoided, the following should be observed
at all times:
• Electrically insulate patients.
• Switch the pacemaker function to asynchronous modes if needed.
• Do not introduce energy near the device system.
• 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
defibrillation. 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 must be avoided 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 conditions 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 therapeutic ionizing radiation:
• Adhere to instructions for potentially risky therapeutic and diagnostic
procedures.
• Shield device against radiation.
• After applying radiation, double-check the device system to make sure it is
functioning properly.
Note: Please contact BIOTRONIK with questions on the risk/benefit analysis.