User's Manual

4
QTECH™ PROGRAMMER: GENERAL DESCRIPTION
• Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detection and therapy
response. Removing the magnet resumes arrhythmia detection and therapy response.
• Battery depletion will eventually cause the SQ-RX Pulse Generator to stop functioning.
Debrillation and excessive numbers of charging cycles shorten the SQ-RX Pulse Generator’s
battery longevity.
• The S-ICD System has not been evaluated for pediatric use.
• The S-ICD System does not provide long-term bradycardia pacing, Cardiac Resynchronization
Therapy (CRT) or Anti-Tachycardia Pacing (ATP).
Use of Other Medical Therapies/Diagnostic Procedures
• External debrillation or cardioversion may damage the S-ICD System. Avoid placing the
debrillation paddles directly over the SQ-RX device or electrode.
• Cardio Pulmonary Resuscitation (CPR) may temporarily interfere with sensing and may cause
delay of therapy.
• 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.
• Do not expose the patient to MRI scanning. MRI scanning can damage the SQ-RX Pulse
Generator and cause patient injury.
• 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.
• Ionizing radiation therapy, such as radioactive cobalt, linear accelerators, and betatrons
may adversely aect 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:
» 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.
» Do not project the radiation port directly at the SQ-RX Pulse Generator.
» Evaluate the S-ICD System operation after each radiation treatment.
• Lithotripsy and other therapeutic forms of ultrasound can damage the SQ-RX Pulse Generator.
If required, avoid direct ow of the pulse waves near the site of the implanted SQ-RX Pulse
Generator.