User's Manual

Given Imaging Ltd.
DOC-0062-02 11
Warnings
A warning indicates a condition that may endanger the patient or the operator.
• A negative or normal result obtained by the capsule does not exclude the presence
of pathology.
• A thorough understanding of the technical principles, clinical applications and
risks associated with the Given M2A Patency 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 Patency Capsule, make sure the patient thoroughly understands the
procedure, and provide the patient with a copy of the Patient Instructions.
• If there is reasonable doubt concerning the integrity of the M2A Patency Capsule,
do not use it.
• Instruct the patient to avoid biting or scratching the M2A Patency Capsule. After
ingestion, query the patient concerning the smoothness of ingestion. If there is
any doubt about the patient biting the capsule or about the integrity of the capsule
after ingestion, no conclusions may be drawn from this examination regarding the
patency of the GI tract. The examination must be repeated after verification of the
extraction of the ingested capsule.
• Do not use a M2A Patency Capsule after its expiration date.
• Make sure that the patient has not ingested any other capsule or other ingestible
diagnostic device before ingestion of the M2A Patency Capsule.
• After ingesting the M2A Patency Capsule and until it is excreted, the patient must
avoid being near any source of powerful electromagnetic fields such as one
created near an MRI device.
• Instruct the patient to contact the physician immediately if any abdominal pain,
nausea or vomiting is experienced after ingesting the M2A Patency Capsule. It
should be noted that patients with tight strictures may experience a mild
abdominal pain.
• Store the M2A Patency Capsule in a safe place out of the reach of children and
infants.
• The safety of this device has not been established in pregnancy.
• The safety of this device in patients with significant gastrointestinal diverticular
disease is unknown.
• This device has not been tested in pediatric population (children 18 and below)
and safety in young children is unknown.