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WARNINGS
NOTE: Before using the S-ICD System, read and follow all warnings and precautions provided in the
EMBLEM S-ICD Pulse Generator User’s Manual.
General
•Labeling knowledge. Read this manual thoroughly before using the S-ICD System to avoid damage to
the pulse generator and/or subcutaneous electrode. Such damage can result in patient injury or death.
•For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization
may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result
in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of
contamination of the device and/or cause patient infection or cross-infection, including, but not limited to,
the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead
to injury, illness, or death of the patient.
•Component compatibility. All Boston Scientific S-ICD implantable components are designed for use with
the Boston Scientific or Cameron Health S-ICD System only. Connection of any S-ICD System
components to a non-compatible component will result in failure to deliver life-saving defibrillation therapy.
•Backup defibrillation protection. Always have external defibrillation equipment and medical personnel
skilled in CPR available during implant and follow-up testing. If not terminated in a timely fashion, an
induced ventricular tachyarrhythmia can result in the patient’s death.
Handling
•Proper handling. Handle the components of the S-ICD System with care at all times and maintain proper
sterile technique. Failure to do so may lead to injury, illness, or death of the patient.
•Do not damage components. Do not modify, cut, kink, crush, stretch, or otherwise damage any
component of the S-ICD System. Impairment to the S-ICD System may result in an inappropriate shock or
failure to deliver therapy to the patient.
