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Product Description
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Product Description
Product Description1GA-HW_en--mul_393468-BTechnical[nbsp ]Manual for the[nbsp ]DeviceIlesto 5/7 VR-T, VR-T DX, DR-T, HF-T
Intended Medical Use
Intended use
Ilesto 5/7 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 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 toler-
ated 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. BIO-
TRONIK 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.