Estella Pulse Generators - BIOTRONIK USA - News

4. Warnings and PrecautionsEstella Pulse Generators Technical Manual 7Certain therapeutic and diagnostic procedures may cause undetecteddamage to a pulse generator, resulting in malfunction or failure at alater time. Please note the following warnings and precautions:Magnetic Resonance Imaging (MRI)—Avoid use of magnetic resonanceimaging as it has been shown to cause movement of the pulse generatorwithin the subcutaneous pocket and may cause pain and injury to thepatient and damage to the pulse generator. If the procedure must beused, constant monitoring is recommended, including monitoring theperipheral pulse.Rate-Adaptive Pacing—Use rate-adaptive pacing with care in patientsunable to tolerate increased pacing rates.High Output Settings—High output settings combined with extremelylow lead impedance may reduce the life expectancy of the pulsegenerator to less than 1 year. Programming of pulse amplitudes, higherthan 4.8 V, in combination with long pulse widths and/or high pacingrates may lead to premature activation of the replacement indicator.4.1 Medical TherapyBefore applying one of the following procedures, a detailed analysis ofthe advantages and risks should be made. Cardiac activity during oneof these procedures should be confirmed by continuous monitoring ofperipheral pulse or blood pressure. Following the procedures, pulsegenerator function and stimulation threshold must be checked.Therapeutic Diathermy Equipment—Use of therapeutic diathermyequipment is to be avoided for pacemaker patients due to possibleheating effects of the pulse generator and at the implant site. Ifdiathermy therapy must be used, it should not be applied in theimmediate vicinity of the pulse generator/lead. The patient’s peripheralpulse should be monitored continuously during the treatment.Transcutaneous Electrical Nerve Stimulation (TENS)—Transcutaneouselectrical nerve stimulation may interfere with pulse generator function.If necessary, the following measures may reduce the possibility ofinterference:• Place the TENS electrodes as close to each other as possible.• Place the TENS electrodes as far from the pulse generator/leadsystem as possible.• Monitor cardiac activity during TENS use.