Product Card

\\\DC - 69664/2 - #1258984 v 1
Directions for Use
• The physician should give the patient “Patient Instructions for Undergoing Capsule
Endoscopy”, printable from the RAPID™ Application and he/she should verify that
the patient understands the instructions.
• The physician should instruct the patient to fast for 8 hours before the test and for
males to shave their abdomen 6 inches above and below the navel on the day of the
test.
• When the patient comes to the clinic on the day of the test, the physician should
proceed according to instructions in the User Manual.
• The physician should have the Sensor Array applied to the patient’s abdomen and
connected to the recorder in the Recorder Belt worn around his/her waist.
• The physician should take the M2A™ Capsule out of its blister and test it according to
instructions in the User Manual.
• If the tests are passed, the physician should instruct the patient to ingest the M2A™
Capsule with a sip of water.
• If for any reason, after activating the M2A™ Capsule by removing it from its blister,
the patient is not taking the M2A™ Capsule, it should be deactivated by replacing it,
in its holder, to the blister. The capsule should stop blinking. If it does not stop on the
first attempt, turn the capsule in its holder and replace in blister until blinking stops.
• Under normal conditions, the time elapsed between activating the capsule and
ingesting it should not exceed 1 minutes.
• Before the patient leaves the clinic, the physician should verify that the patient has a
copy of “Patient Instructions for Undergoing Capsule Endoscopy” printable from the
RAPID™ Application and he/she should verify that the patient understands the
instructions.
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 M2A™ Capsule is necessary before using this product.
• The patient should thoroughly understand how he/she is required to behave during
Capsule Endoscopy.
• In patients with strictures of the GI tract, the M2A™ Capsule can potenially cause
intestinal obstruction resulting in the need for hospitalization and surgery. The use of
the M2A™ Capsule in patients with strictures of the GI tract is contraindicated.
• If there is reasonable doubt concerning the integrity of the M2A™ Capsule, 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.
• The M2A™ Capsule should not be used after its expiration date.
• The M2A™ Capsule is not to be ingested before it has been ascertained by a physician
that there is no other M2A™ Capsule or other swallowable diagnostic device within
the patient.
• The patient should be instructed to avoid biting the M2A™ Capsule prior to
swallowing.