Rivacor 5 HF-T - Biventricular pacemaker/defibrillator

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Dostopno od:

Biotronik Australia Pty Ltd

Razred:

AIMD

Izdeluje:

Biotronik SE & Co KG Woermannkehre 1, Berlin, D-12359 Germany

Terapevtsko območje:

47270 - Biventricular pacemaker/defibrillator

Terapevtske indikacije:

A triple chamber rate adaptive ICD, with Home Monitoring functions, max. shock of 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 implanting in the pectoral muscle area. Connections for bipolar pacing, sensing, unipolar connections and shock delivery are found in the header. MR conditional. Rivacor 5 HF-T belongs to a family of implantable cardioverter-defibrillators (ICDs). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite 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 c

Status dovoljenje:

A

Datum dovoljenje:

2019-03-18

Lastnosti izdelka

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 [phone]
Fax[phone]
[e-mail]
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.............................................................................................