Radiation therapy: Avoid exposure to ionizing radiation. Betatrons
are contraindicated. If high doses of radiotherapy cannot be avoided,
the pacemaker should be protected from direct exposure, and
pacemaker operation should be monitored continuously. Resulting
damage may be immediately undetectable. If irradiation of tissues
close to the implantation site is necessary, it is recommended that
the pacemaker be moved. As a safety measure, temporary
pacemaker back-up should be immediately available.
Lithotripsy: The risks associated with lithotripsy are limited if the
cardiac pacemaker is not implanted in the abdominal position.
However, in order to avoid all risk of ventricular or atrial fibrillation,
shocks should be administered synchronously with pacing.
Ultrasound: The pacemaker should not be exposed to therapeutic
levels of ultrasound.
Transcutaneous Electrical Nerve Stimulation (TENS): TENS may
interfere with pacemaker function. If necessary, the following
measures may reduce interference: 1. Place the TENS electrodes as
close together as possible and as far as possible from the pulse
generator and leads. 2. Monitor cardiac activity during TENS use.
4.2. STORAGE
The pacemaker is packaged in a sterile pack contained within a
cardboard storage package. It is recommended that the pacemaker
be stored at a temperature ranging from 0 °C to 50 °C.
The cardboard package protects the pacemaker from impact during
shipping.
Devices subjected to excessive impact, such as those that have
been dropped on a hard floor, should not be implanted. Any device
subjected to such an impact should be returned to your Sorin CRM
representative for examination.
8 –
ENGLISH