Product Card

\\\DC - 69664/2 - #1258984 v 1
• 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.
• If after ingesting the M2A™ Capsule the patient has any abdominal pain, nausea or
vomiting, he/she should contact the physician immediately.
• This M2A™ Capsule must be stored, in a safe place out of the reach of children
and/or infants.
• If contrary to instructions a patient ingested two capsules, he/she should be instructed
to contact the physician immediately.
• If a child has accidentally swallowed an unused or spent M2A™ Capsule, he should
be brought immediately to a hospital.
• The M2A™ Capsule should be ingested only in the presence of authorized personnel.
The patient should be instructed not to let his/her relatives, neighbors or acquaintances
use the M2A™ Capsule.
• This device has not been tested in pediatric population (children 18 and below) and
safety in young children is unknown.
How will the M2A™ Capsule affect the daily routine of the patient?
The patient will have to prepare for Capsule Endoscopy in the following manner:
• The patient will have to abstain from eating or drinking for 8 hours before undergoing
this test.
• The patient may take medication up till two hours before and resume once again two
hours after M2A ingestion, with a sip of water.
• The patient will have to shave his abdomen 6 inches above and below the navel on the
day of the test (for males).
• At the physician’s office, a Sensor Array will be put on the patient’s abdomen and will
be connected to a recorder worn on a belt around his/her waist for the duration of the
test. The patient will then be instructed to ingest the M2A™ Capsule.
• After ingesting the capsule, the patient will have to abstain from eating or drinking for
another 2 hours. After 2 hours the patient may drink water. Four hours after ingesting
the capsule the patient may have a light snack. After completion of the study the
patient may return to normal diet.
• The test will last 8 hours. During the test the patient will have to avoid any physical
activity that involves sweating. The patient will have to abstain from bending or
stooping during the test. The patient must be instructed to never remove the belt
during the test.
• At the end of 8 hours, the Sensor Array and Recorder Belt can be removed and
returned as instructed to the physician.
• The M2A™ Capsule is disposable and it will be excreted naturally in the patient’s
bowel movements.
Drug Interactions
• The patients may take their usual prescribed medication up till two hours before and
resume once again two hours after M2A™ Capsule ingestion, with a sip of water.