Warnings and general precautions

• During the implantation procedure a defibrillator must be kept on hand in case of emergency.

• Never bend, twist or strain the pacing lead while manoeuvering it; using excess force may permanently damage the device.

• Avoid contaminating the pacing lead with pieces of gauze, powder or other non-sterile material. Handle the lead using surgical gloves.

• Repositioning or removing a lead may be difficult due to growth of fibrous tissue. The lead connections or tip may loosen due to improper traction on the lead.

• Avoid grasping the pacing lead with surgical instruments as this may cause arrhythmias or damage the lead.

• Endocardial pacing leads should not be implanted in patients suffering from tricuspid valve dysfunctions.

• Do not implant in patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate may be contraindicated.

• Pacing leads are implanted in the extremely hostile environment of the human body and may also be damaged inadvertently during implantation. Despite the exercise of all due care in design, component selection, manufacture and quality assurance, pacing leads may fail to function after implantation. Reports from the literature and clinical experience indicate that implantation of cardiac pacing leads may be associated with clinical complications such as infection, tip displacement, myocardial perforation and abnormal tissue reaction. Consequently, causes of device failure or clinical complications may be various and sometimes difficult to manage. Sorin Biomedica CRM S.r.l., therefore, disclaims any responsibility for damages resulting from possible lead failure and/or clinical complications associated with their use.

• Every electrode advancement and retraction in the vein must be performed by gently turning the electrode counterclockwise in order to avoid injuring the vessel.