User's Manual

5
QTECH™ PROGRAMMER: GENERAL DESCRIPTION
• Use caution during ablation procedures. Program the S-ICD System to Therapy O. Keep the
current path (electrode tip to ground) as far away as possible from the implanted SQ-RX Pulse
Generator and electrode.
• The programmer is not suitable for use in the presence of a ammable anesthetic mixture with
air or with oxygen or nitrous oxide.
Electromagnetic Interference (EMI) Outside the Hospital Environment
Exposure to EMI or static magnetic elds may suspend tachycardia detection and possibly cause
temporary inhibition of therapy delivery. EMI may also trigger delivery of a shock in the absence
of a tachycardia. Automatic sensing and detection of tachycardias will resume when the patient
moves away from the EMI or static magnetic eld source.
To minimize the risk, advise patients to avoid sources of EMI or static magnetic elds having
strengths of >10 gauss or 1 mTesla.
• Sources of EMI include, but are not limited to:
» High-voltage power lines
» Arc welding equipment
» Electrical smelting furnaces
» Large radio-frequency transmitters (such as radar)
» Alternators on running engines in automobiles
» Communications equipment (such as high-power radio transmitters)
• Sources of strong static magnetic elds may include the following:
» Industrial transformers and motors
» Large stereo speakers
» Magnetic wands, such as those used for airport security
Patients should seek medical guidance from their physician before entering an area where a posted
sign prohibits patients with an implantable cardioverter debrillator or pacemaker.
S-ICD System Clinical Investigation
A summary of the S-ICD System Clinical Investigation, including observed adverse events is
provided in the SQ-RX® Pulse Generator User’s Manual.