User's Manual Part 1

Important Information - Please Read Before Use
13
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Exclusion criteria
• Risk of capsule examination:
The capsule endoscope is warranted for remaining within the body for
up to 30 days. If the capsule endoscope is not excreted from the body, it
must be collected using an endoscope or by surgery, within 30 days
from the date of ingestion. To determine the location of the capsule
endoscope within the patient’s body, an X-ray examination may be
required. For this reason, the following exclusion criteria have been set.
Be sure to explain this risk to the patient and obtain his/her consent prior
to the examination.
− Patients who have not given the consent.
− Patients who, as a result of X-ray examinations or past profiling
examinations, have been determined to have a obstruction clear
narrowing, adhesion, and/or diverticula in the gastrointestinal tract
which may interfere with the passing capsule endoscope.
− Patients who have had open abdominal surgery.
− Patient is a non-surgical candidate.
− Pregnant women.
− Patients with serious gastrointestinal transit delay.
• The capsule endoscope may accidentally go down the trachea, if the
patient has difficulties in swallowing.
• Patients using equipment that may be affected by radio transmission (i.e.
cardiac pacemaker and other implanted electrical medical devices). The
capsule endoscope has not been tested with such equipment for safety.
User qualifications
• The operator of this system must be a physician or medical personnel
under the supervision of a physician and must have received sufficient
training in endoscopic procedures. This manual, therefore, does not
explain or discuss endoscopic procedures.
• Analysis of the captured endoscopic images require substantial training.