User's Manual

Given Imaging Ltd.
6 DOC-0062-02
After ingestion, the M2A Patency Capsule is propelled by peristalsis through the
gastrointestinal tract. Detection of an RF signal three days following ingestion
means that the capsule is still retained in the GI tract. This may indicate a problem
with the patency of the GI tract. In case the capsule is retained in the GI tract even
longer, a disintegration process begins, to enable normal excretion of the resulting
small fragments.
The M2A Patency Capsule acts through the following two phases:
Intact – This phase lasts for 80 hours. During this phase the capsule maintains its
dimensions and rigidity while traveling through the various sections of the GI tract
by peristalsis. The capsule withstands the various chemical and physical conditions
of the GI tract. In most cases it is naturally excreted while still in the intact phase.
Disintegration – This phase occurs only after the capsule stays in the GI tract more
than 80 hours. During this phase, first the timer plug erodes, followed by the body.
The remaining parts are excreted naturally.
The M2A Patency Capsule is provided ready for ingestion in a hermetically sealed
blister. Prior to ingestion, the physician tests the functionality of the capsule. The
patient ingests the capsule immediately after testing.
For specifications and technical parameters of the M2A Patency Capsule, refer to
Specifications on page 14.