ИМПЛАНТИРУЕМЫЙ КАРДИОВЕРТЕР-ДЕФИБРИЛЛЯТОР С ПОДКОЖНЫМ ДЕФИБРИЛЛИРУЮЩИМ ЭЛЕКТРОДОМ EMBLEM S ICD
A sterile implantable pulse generator with a system for recognizing cardiac arrhythmias during electrocardiogram (ECG) analysis. The device delivers an electrical impulse to the heart muscle in order to restore normal heart rhythm or slow down rapid heartbeat. It is implanted in a pocket under the skin in the patient’s chest area and has an attached lead that is placed under the skin of the chest in the heart area for monitoring ECG and automatically delivering electrical impulses. The device contains internal batteries for power supply. It is often referred to as an automatic implantable cardioverter-defibrillator (AICD). The device’s design allows for safe MRI scans up to 1.5T for patients.
Weight (g), no more than 130.
Volume (cm3), no more than 60.
Nominal service life, years, no less than 7.3.
Body material: titanium.
MRI compatibility: available.
Number of tachycardia zones, no less than 2.
Minimum tachycardia recognition frequency (beats/min), no less than 170. The frequency programming range for the shock zone is 170 to 250 beats per minute.
The frequency programming range for the arrhythmia discrimination zone is 170 to 240 beats per minute.
Post-shock stimulation is available.
The number of perception (detection) vectors is at least 3.
The maximum charge energy is at least 80 J.
The range of applied energy for cardioversion treatment of ventricular tachycardias is 10 to 80 J.
The number of shocks per episode is at least 5.
The number of stored episodes of arrhythmias is at least 40.
The number of stored episodes of atrial fibrillation is at least 7.
The subcutaneous defibrillating electrode is included.
The electrode type is tripolar. The electrode length (cm) is at least 45. The maximum electrode diameter is no more than 3.84 mm.
The electrode insulation material is polyurethane.
The defibrillating spiral area is at least 750 mm2.
The proximal electrode area is at least 46 mm2.
The distal electrode area is at least 36 mm2.
The electrode pole spacing is at least 120 mm.
