User's Manual

12 OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL
Dangers, warnings and cautions
Follow the dangers, warnings and cautions given below when handling the
system. This information is to be supplemented by the dangers, warnings and
cautions given in each chapter.
• This system is contraindicated to patients with the following conditions.
− Patients with cardiac pacemakers or other implanted electronic devices
(e.g., defibrillators)
(Cardiac pacemakers or other implanted electronic
devices may malfunction due to the RF (radio frequency)
interference.)
− Patients with known intestinal strictures, adhesions,
diverticulum, obstruction, or fistulas that may block the
passage of the capsule endoscope
(Patients with these physical features risk retention of the
capsule endoscope.)
− Patients with known dysphagia
(Patients with dysphagia may have a risk of aspiration into
the tracheal branches and could have difficulty ingesting
the capsule endoscope.)
− Patients with significant difficulty in swallowing a tablet as
large as capsule endoscope
(Patients that may have difficulty ingesting a capsule as
large as the capsule endoscope risk getting the capsule
lodged in their throat.)
− Patients who are nonsurgical candidates
Open surgery is required if the capsule endoscope is
retained in the patient’s body.
− Patients who are pregnant
Use of the capsule endoscope has not yet been proven to
be safe on pregnant patients.
− Patients with significant gastrointestinal tract delay
Long-term retention of the capsule endoscope may be
observed in patients with known radiation enteritis due to
intestinal strictures or adhesions.
− Patients diagnosed with radiation enteritis
Long-term retention of the capsule endoscope may be
observed in patients with known radiation enteritis due to
intestinal strictures or adhesions.