Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Biotronik Australia Pty Ltd
AIMD
Biotronik SE & Co KG Woermannkehre 1, Berlin, D-12359 Germany
35852 - Defibrillator, implantable, automatic
A single chamber, rate adaptive ICD with Home Monitoring functions, max. shock energy 40J and DF4/IS-1 connector. Biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. Ellipsoid shape facilitates implantation in the pectoral muscle area. The connections for bipolar pacing, sensing and shock delivery are in the header. DX functionality also senses in the right atrium. MR conditional. Rivacor 5 VR-T DX belongs to a family of implantable cardioverter-defibrillators (ICD). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias with ventricular pacing. The implantation of an ICD is a symptomatic therapy with the following objectives: ?Termination of spontaneous ventricular fibrillation (VF) through shock delivery ?Termination of spontaneous ventricular tachycardia (VT) through antitachycardia pacing (ATP); in case of ineffe
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2019-03-18
Rivacor 3/5/7 ICD Family VR-T, VR-T DX, DR-T, HF‑T, HF‑T QP Technical Manual 439132 Revision: D (2019-02-15) BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany Tel +49 (0) 30 68905-0 Fax+49 (0) 30 6852804 sales@biotronik.com www.biotronik.com © BIOTRONIK SE & Co. KG. All rights reserved. Specifications subject to modification, revision and improvement. ® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner. 0123 2018 Table of Contents 1 Table of Contents 1 Product Description......................................................................................................... 2 Intended Medical Use ............................................................................................................................. 2 System Overview ..................................................................................................................................... 4 Therapeutic and Diagnostic Functions ................................................................................................ 10 2 General Safety Instructions........................................................................................... 13 General Information on Safe Handling of the Device.......................................................................... 13 Operating Conditions ............................................................................................................................ 15 Possible Complications ........................................................................................................................ 16 Possible Risks....................................................................................................................................... 18 3 Implantation .................................................................................................................. 20 Implantation Procedure............................................................................................. Read the complete document