Estella Pulse Generators - BIOTRONIK USA - News

11. Lead ConnectionEstella Pulse Generators Technical Manual 107Estella pulse generators have been designed and are recommended foruse with bipolar or unipolar leads having an IS‐1 connector. The IS‐1configured leads may be placed in one or both chambers of the heart,depending upon model selected.WarningUnipolar/Bipolar—All Estella models can be used witheither unipolar or bipolar IS‐1 leads.If the pacing or sensing function is to be programmed tobipolar, it must be verified that bipolar leads have beenimplanted in that chamber. If either of the leads is unipolar,unipolar sensing and pacing functions must be programmedin that chamber. Failure to program the appropriate leadconfiguration could result in entrance and/or exit block.NOTE:Connecting systems with a 3.2 mm configuration that do notexpressly claim to agree with the IS-1 dimensions generally haveto be regarded as incompatible with IS‐1 connectors and can onlybe used with BIOTRONIK products together with an appropriateadapter. For questions regarding lead-generator compatibility,consult your BIOTRONIK representative.In case of pulse generator replacement, make sure that the existinglead connector and lead are not damaged.CautionLead/pulse Generator Compatibility—Because of thenumerous available 3.2-mm configurations (e.g., the IS-1 andVS-1 standards), lead/pulse generator compatibility should beconfirmed with the pulse generator and/or lead manufacturerprior to the implantation of a pacing system.IS-1, wherever stated in this manual, refers to the internationalstandard, whereby leads and generators from differentmanufacturers are assured a basic fit. [Reference ISO 5841-3:1992(E)].