Boston Scientific Corporation CRMA20914 Manuel D’Utilisation

Select the Exit button to exit the induction process and return to the Main Menu screen.

The following functions occur during the test:

•

The S-ICD System induces ventricular fibrillation using 200 mA alternating current (AC) at 50 Hz.

Induction continues until the Hold To Induce button is released (up to a maximum of 10 seconds per

attempt).

Note: If necessary, the induction can be terminated by disconnecting the wand from the

programmer.

•

Arrhythmia detection and the Live S-ECG are suspended during AC induction. Once the Hold to Induce

button is released, the programmer displays the patient’s rhythm.

•

Upon detection and confirmation of an induced arrhythmia, the S-ICD System automatically delivers a

shock at the programmed energy output and polarity.

Note: Whenever the programmer is in active communication with an S-ICD pulse generator,

charging of the pulse generator in preparation for delivering a shock (whether commanded or in

response to a detected arrhythmia) is indicated by an audible notification. The notification continues

until the shock is delivered or aborted.

•

If the shock fails to convert the arrhythmia, re-detection occurs and subsequent shocks are delivered at

the pulse generator’s maximum energy output (80 J).

Note: The EMBLEM S-ICD pulse generator can deliver a maximum of five shocks per episode. At any

time, an 80 J rescue shock can be delivered by pressing the Rescue Shock button.
Note: Following the release of the Hold To Induce button, evaluate the sensing markers during the

induced rhythm. The S-ICD System uses a lengthened rhythm detection period. Consistent tachy

“T” markers indicate that tachyarrhythmia detection is occurring, and that capacitor charging is

imminent. If a high degree of amplitude variation is noted during the arrhythmia, a slight delay may

be expected prior to capacitor charging or shock delivery.

If appropriate sensing or VF conversion cannot be demonstrated, consider changing the selected sense configuration or

relocating the subcutaneous electrode or device and then retest. VF conversion testing can be conducted in either polarity.

Complete and Return the Implantation Form

Within ten days of implantation, complete the Warranty Validation and Lead Registration form and return the original to

Boston Scientific along with copies of the Summary Report, Captured S-ECG Report, and Episode Report(s) printed from

the programmer. This information enables Boston Scientific to register each implanted pulse generator and subcutaneous

electrode, and provide clinical data on the performance of the implanted system. Keep a copy of the Warranty Validation and

Lead Registration form and programmer printouts for the patient’s file.