Tabla De Contenido; Product Description; Intended Medical Use - BIOTRONIK Idova 7 Manual Tecnico

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Table of Contents
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Therapeutic and Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Precautionary Measures while Programming . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Follow-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Bradycardia / CRT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Tachycardia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Electrical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Battery Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Legend for the Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

1 Product Description

Intended Medical Use

Intended use
Idova 7 is part of a familiy of implantable cardioverter-defibrillators (ICDs). 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 case of ineffective ATP or hemodynamically not tolerated VT, with
shock delivery
• Cardiac resynchronization through multisite ventricular pacing (triple-chamber
devices)
• Compensation of bradycardia through ventricular (single-chamber devices) or
AV sequential pacing (DX, dual and triple-chamber devices)
Diagnosis and therapy forms
The device monitors the heart rhythm and automatically detects and terminates
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.
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation and the operation conditions of a device system.
• Only qualified medical specialists having this special knowledge required are
permitted to use implantable devices.
• If users do not possess this knowledge, they must be trained accordingly.
Indications
Idova can treat life-threatening ventricular arrhythmias with antitachycardia pacing
and defibrillation.
Generally approved differential diagnostics methods, indications, and recommenda-
tions for ICD therapy apply to BIOTRONIK devices. See the guidelines of cardiology
associations for guidance.
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