BIOTRONIK SE & Co. KG ICD4200 사용자 설명서
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Product Description
Intended Medical Use
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Product Description
Product Description1439132Technical ManualRivacor 3/5/7
Intended Medical Use
Intended use
Rivacor 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 resynchroni-
zation therapy with multisite ventricular pacing.
primary objective of the therapy is to prevent sudden cardiac death. Furthermore,
the device is capable of treating bradycardia arrhythmias and cardiac resynchroni-
zation 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 antitachy-
cardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated
VTs, with shock delivery
cardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated
VTs, with shock delivery
•
Cardiac resynchronization through multisite ventricular pacing (triple-chamber
devices)
devices)
•
Compensation of bradycardia through ventricular (single-chamber devices) or
AV sequential pacing (DX, dual- and triple-chamber devices).
AV sequential pacing (DX, dual- and triple-chamber devices).
VR-T DX and HF-T/HF-T QP devices types with DX functionality are only
indicated for patients not requiring atrial pacing.
indicated for patients not requiring atrial pacing.
Diagnosis and therapy forms
The device monitors the heart rhythm and automatically detects and treats cardiac
arrest resulting from ventricular tachyarrhythmia. All major therapeutic
approaches from the field of cardiology and electrophysiology are included.
BIOTRONIK Home Monitoring enables physicians to perform therapy management
at any time.
arrest resulting from ventricular tachyarrhythmia. All major therapeutic
approaches from the field of cardiology and electrophysiology are included.
BIOTRONIK Home Monitoring enables physicians to perform therapy management
at any time.
Indications
Rivacor can treat life-threatening ventricular arrhythmias with antitachycardia
pacing and defibrillation.
pacing and defibrillation.
Generally approved differential diagnostics methods, indications, and recommen-
dations for ICD therapy apply to BIOTRONIK devices. See the current guidelines of
cardiology associations for guidance.
dations for ICD therapy apply to BIOTRONIK devices. See the current guidelines of
cardiology associations for guidance.
We recommend observing the indications published by the German Cardiac Society
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung, (DGK)) and
the European Society of Cardiology (ESC). This also applies to the guidelines
published by the Heart Rhythm Society (HRS), the American College of Cardiology
(ACC), the American Heart Association (AHA), and other national cardiology associ-
ations.
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung, (DGK)) and
the European Society of Cardiology (ESC). This also applies to the guidelines
published by the Heart Rhythm Society (HRS), the American College of Cardiology
(ACC), the American Heart Association (AHA), and other national cardiology associ-
ations.
Single-chamber and
dual-chamber
Single-chamber and dual-chamber ICDs are indicated for patients with the
following risk:
following risk:
•
Sudden cardiac death caused by ventricular arrhythmias
Triple-chamber
Triple-chamber ICDs are indicated for patients with the following risks:
•
Sudden cardiac death caused by ventricular arrhythmias
•
Congestive heart failure with ventricular asynchrony