User's Manual

Overview
Given Imaging Ltd.
10
Warnings
WarningsWarnings
Warnings
A Warning indicates a condition that may endanger the
patient or the operator.
Warnings
• The M2A™ Capsule should be used only after consulting
a physician.
• A thorough understanding of the technical principles,
clinical applications and risks associated with the Given®
Diagnostic Imaging System is necessary before using this
product. Read the entire manual before using the system
for the first time.
• To prevent the patient from being exposed to unforeseen
risks during passage of the M2A™ Capsule, make sure
the patient thoroughly understands the procedure, and
provide the patient with a copy of the
Patient Instructions
for Undergoing Capsule Endoscopy
. (You can print it
from the RAPID™ Application.)
• If there is reasonable doubt concerning the integrity of
the M2A™ Capsule due to dropping, biting or any other
eventuality, it should not be used until consulting with an
authorized Given® representative and should be
deactivated by returning it in its holder into its blister.
• Do not use an M2A™ Capsule after its expiration date.
• Instruct the patient to avoid biting the M2A™ Capsule
prior to swallowing.
• After ingesting the M2A™ Capsule and until it is
excreted, the patient should not be near any source of
powerful electromagnetic fields such as one created near
an MRI device.