Intended Use; Intended Audience; Indications For Use / Contraindications / Warnings And Precautions - Boston Scientific EMBLEM S-ICD Manual Del Usuario

Description
The Model 2889 EMBLEM S-ICD Automated Screening Tool (AST)
is software used on the Model 3120 ZOOM LATITUDE Programmer
to screen patients to assess them for implant of the EMBLEM
Subcutaneous Implantable Cardioverter Defibrillation (S-ICD) system.
These instructions describe how to use the AST.

Intended Use

The AST application is soley intended to screen patients for S-ICD
implant and is not intended to be used for any cardiac diagnostic
purpose. The AST is an alternative to the Model 4744 Patient Screening
Tool. The two screening tools serve the same purpose, and may be used
independently or together.

Intended Audience

This AST is intended for use by professionals trained or experienced in
device implant and/or follow-up procedures.
Indications for Use / Contraindications / Warnings
and Precautions
There are no indications, contraindications, warnings or precautions
specific to the Model 2889 EMBLEM S-ICD Automated Screening Tool
(AST). Refer to the appropriate S-ICD System Pulse Generator (PG)
User Manual for a list of indications for use, allowed concomitant device
settings, contraindications, and warnings and precautions for the S-ICD
system.
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