Danger, Warnings And Cautions - Olympus EndoCapsule Instruction Manual

Danger, warnings and cautions

OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Follow the dangers, warnings and cautions given below when handling the
Olympus capsule endoscope system. This information is to be supplemented by
the dangers, warnings and cautions given in each chapter.
Instruct the patient to stay away from generators of strong
electromagnetic fields (such as MRI equipment), between
ingestion and excretion of the capsule endoscope.
Otherwise, injury within the body cavity may occur.
• The effect of the capsule endoscope on the safety of the
patient's body has only been tested for a period of 30 days. If
the excretion of the capsule endoscope has not been
confirmed, conduct an X-ray examination in an attempt to
locate the capsule endoscope within the patient's body. If the
capsule endoscope is located within the body, it must be
collected within 30 days from the date of ingestion.
• Regardless of the positive/negative result, one examination
does not cover all of the small intestine. Continuous checkup
is required.
• Avoid use under combustible environments, such as:
− where the concentration of oxygen is high.
− where oxidizing agents, such as nitrous oxide (N
− nearby a location using combustible anesthetic gases.
The system is not explosion-proof, and may cause an
explosion or a fire.
• The capsule endoscope is a TYPE BF applied part, which
means that application to the heart is prohibited. Do not use it
for the purpose of observing or treating the heart.
• Do not attach the recorder unit to the recorder unit cradle
while the antenna lead set is attached to the patient. Electric
shock and burns may result in the worst case.
• The capsule endoscope is a sterilized single-use product. Do
not reuse it. Doing so may result in an infection of the patient
and/or medical personnel, as well as internal injury to the
patient due to equipment damage.
Important Information - Please Read Before Use
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