Estella Pulse Generators - BIOTRONIK USA - News

10 Estella Pulse Generators Technical ManualTightening Setscrew(s)—Do not overtighten the setscrew(s). Use onlythe BIOTRONIK supplied torque wrench.Sealing System—Be sure to properly insert the torque wrench intothe perforation at an angle perpendicular to the connector receptacle.Failure to do so may result in damage to the plug and its self-sealingproperties.4.4 Programming and OperationNegative AV Delay Hysteresis—This feature insures ventricularpacing, a technique which has been used in patients with hypertrophicobstructive cardiomyopathy (HOCM) with normal AV conduction inorder to replace intrinsic ventricular activation. No clinical study wasconducted to evaluate this feature, and there is conflicting evidenceregarding the potential benefit of ventricular pacing therapy for HOCMpatients. In addition, there is evidence with other patient groups tosuggest that inhibiting the intrinsic ventricular activation sequenceby right ventricular pacing may impair hemodynamic function and/orsurvival.Programming VCC—If the SA/CV sequence is not successful, programanother pulse width or test start amplitude. If still unsuccessful,program the pacing pulse amplitude manually.NIPS—Life threatening ventricular arrhythmias can be induced bystimulation in the atrium. Ensure that an external cardiac defibrillator iseasily accessible. Only physicians trained and experienced in tachycardiainduction and reversion protocols should use non-invasive programmedstimulation (NIPS).Unipolar/Bipolar—All Estella models can be used with either unipolaror bipolar IS‐1 leads.If the pacing or sensing function is to be programmed to bipolar,it must be verified that bipolar leads have been implanted in thatchamber. If either of the leads is unipolar, unipolar sensing and pacingfunctions must be programmed in that chamber. Failure to program theappropriate lead configuration could result in entrance and/or exit block.Programmers—Use only appropriate BIOTRONIK programmersequipped with appropriate software to program Estella pulse generators.Do not use programmers from other manufacturers.Pulse Amplitude—Programming of pulse amplitudes, higher than 4.8 V,in combination with long pulse widths and/or high pacing rates can leadto premature activation of the replacement indicator.