Boston Scientific Corporation CRM70514 Manual De Usuario

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Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detection and therapy 

response. Removing the magnet resumes arrhythmia detection and therapy response.

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Battery depletion will eventually cause the SQ-RX Pulse Generator to stop functioning. 

Defibrillation and excessive numbers of charging cycles shorten the SQ-RX Pulse Generator’s 

battery longevity.

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The S-ICD System has not been evaluated for pediatric use.

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The S-ICD System does not provide long-term bradycardia pacing, Cardiac Resynchronization 

Therapy (CRT) or Anti-Tachycardia Pacing (ATP).

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External defibrillation or cardioversion may damage the S-ICD System. Avoid placing the 

defibrillation paddles directly over the SQ-RX device or electrode.

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Cardio Pulmonary Resuscitation (CPR) may temporarily interfere with sensing and may cause 

delay of therapy.

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Do not expose a patient with an implanted S-ICD System to diathermy. The interaction of 

diathermy therapy with an implanted SQ-RX Pulse Generator can damage the SQ-RX Pulse 

Generator and cause patient injury.

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Do not expose the patient to MRI scanning. MRI scanning can damage the SQ-RX Pulse 

Generator and cause patient injury.

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Electrical interference or “noise” from sources such as electrosurgical and monitoring 

equipment can interfere with the communication between the programmer and SQ-RX Pulse 

Generator or cause inappropriate therapy. If interference occurs, move and reposition the 

programmer or wand away from the source of the interference.

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Ionizing radiation therapy, such as radioactive cobalt, linear accelerators, and betatrons 

may adversely affect the S-ICD System operation. Therapeutic ionizing radiation cannot be 

immediately detected; however, it can damage the electronic components of the SQ-RX Pulse 

Generator. To minimize the risks of ionizing radiation:

 

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Shield the SQ-RX Pulse Generator with a radiation-resistant material, regardless of the 

distance between the SQ-RX Pulse Generator and the radiation beam.

 

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Do not project the radiation port directly at the SQ-RX Pulse Generator.

 

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Evaluate the S-ICD System operation after each radiation treatment.

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Lithotripsy and other therapeutic forms of ultrasound can damage the SQ-RX Pulse Generator. 

If required, avoid direct flow of the pulse waves near the site of the implanted SQ-RX Pulse 

Generator.