Boston Scientific Corporation CRMA20914 Manual De Usuario

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This section presents the information necessary for implanting and testing the S-ICD System, including:

Implanting the EMBLEM S-ICD pulse generator (the “device”)

Implanting the EMBLEM S-ICD subcutaneous electrode (the “electrode”) using the EMBLEM S-ICD 

subcutaneous electrode insertion tool (the “EIT”)

Setting up and testing the device using the EMBLEM S-ICD programmer (the “programmer”).

Warning: All Boston Scientific S-ICD implantable components are designed for use with the Boston Scientific or 

compatible component will result in failure to deliver life-saving defibrillation therapy.
The S-ICD System is designed to be positioned using anatomical landmarks.  However, 

it is recommended to review a pre-implant chest x-ray in order to confirm that a 

patient does not have notably atypical anatomy (e.g. dextrocardia). Additionally, it 

is not recommended to deviate from the implant instructions to accommodate for 

physical body size or habitus, unless a pre-implant chest x-ray has been reviewed.
The device and subcutaneous electrode are typically implanted subcutaneously in the 

left thoracic region  (Figure 13).  The EIT is used to create the subcutaneous tunnels in 

which the electrode is inserted.

Figure 13: Placement of the S-ICD System

Check Equipment
It is recommended that instrumentation for cardiac monitoring and defibrillation be available during the implant procedure. 

This includes the S-ICD System Programmer with its related accessories and the software application. Before beginning the 

implantation procedure, become completely familiar with the operation of all the equipment and the information in the 

respective user’s manuals. Verify the operational status of all equipment that may be used during the procedure. In case of 

accidental damage or contamination, the following should be available:

Sterile duplicates of all implantable items

Wand in a sterile barrier

Torque and non-torque wrenches

During the implantation procedure, always have a standard transthoracic defibrillator with external pads or paddles available 

for use during defibrillation threshold testing.