User Manual

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 unless the cardiac pacemaker is implanted in
the abdominal position. However, in order to avoid all risk of ventricular or atrial fibrillation,
shocks should be administered synchronously with pacing.
Therapeutic 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.
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 MicroPort representative for examination.
Devices MUST NOT be interrogated and programmed within the vicinity of other devices.
PACKAGING
Characteristics of the sterile package
The pacemaker and its ratchet screwdriver are sterilized with ethylene oxide.
Once sterilized, the contents are hermetically sealed in a transparent dual package in
accordance with international standards.
Characteristics of the non-sterile package
― Identification stickers
― Patient booklet & patient implant card
― Implant registration form and USA return envelope
― Website leaflet
4.4.
4.5.
4.5.1.
4.5.2.
4. WARNINGS
18 ALIZEA – UA10414A