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General Safety Instructions
Possible Risks
Risky diagnostic and
therapeutic procedures
If electrical current from an external source is conducted through the body for diag-
nostic or therapeutic purposes, then the implant can be subjected to interference
and the patient placed at risk. Therefore the following always applies:
• Monitor the patient.
External defibrillation The implant 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, sens-
ing properties and pacing thresholds may change.
• Place adhesive electrodes anterior-pos terior or perpendicular to the axis
formed by the implant to the heart at least 10 cm away from the device and from
implanted leads.
Contraindicated procedures The following procedures are contraindicated:
• Therapeutic ultrasound and diathermy: damage to the patient via excess warm-
ing of body tissue near the implant system
• Transcutaneous electrical nerve stimulation (TENS)
• Lithotripsy
• Electrocautery and high-frequency surgery: damage to the patient via the
induction of arrhythmia or ventricular fibrillation
• Hyperbaric oxygen therapy
• Applied pressures higher than normal pressure
Magnetic resonance
imaging
Magnetic resonance imaging is contraindica ted due to the associated magnetic flux
density: damage or destruction of the implant system by strong magnetic interac-
tion and damage to the patient by excessive warming of the body tissue in the area
surrounding the implant system.
• Under certain conditions one can perform special measures with magnetic res-
onance imaging to protect the patient and implant.
Therapeutic
ionizing radiation
Radiation can cause latent damage. This damage cannot be recognized immedi-
ately. Therefore, the following applies to X-ray diagnosis and radiation therapy:
• Sufficiently shield implant against radiation.
• After applying radiation, double-check the implant system to make sure it is
functioning properly.