User's Manual

Indications, Contraindications, Warnings, Cautions
Adverse Events 5
• In patients with dysphagia or other swallowing disorders.
• In patients with allergies or known contraindication to the medications and preparation agents used
in the procedure as described in the relevant instructions for use.
Adverse Events
Potential adverse events associated with the use of this device may include delayed or no excretion of
the capsule, aspiration, obstruction, perforation, and mucosal injury or bleeding. In some instances,
intervention is required to remove the capsule.
Warnings
Procedure Related:
• The absence of blood when performing an evaluation with the PillCam UGI video capsule does not
exclude the presence of a significant bleeding site in the acute upper gastrointestinal (esophagus,
stomach and duodenum).
• The PillCam COLON 2 capsule may be used for individuals after an incomplete optical
colonoscopy with adequate preparation, and a complete evaluation of the colon, was not
technically possible.
• A normal or negative capsule endoscopy examination does not exclude the possibility of colon
polyps or colon cancer.
• A negative or normal result obtained by the PillCam video capsule does not exclude the presence
of pathology and if symptoms persist, further evaluation should be performed.
• The safety of the PillCam SB capsule has not been established in children below two years of age.
• The safety of the PillCam ESO/PillCam UGI capsule has not been established in patients below
age 18.
• The safety of the PillCam COLON capsule has not been established in patients below age 18.
• In a small number of cases, the PillCam COLON capsule used for Colon capsule endoscopy may
not image the entire large bowel (colon) due to variations in patient GI motility. In the MA-204
study 104 (11.8%) subjects were excluded due to issues with the capsule procedure including 77
(8.7%) subjects with inadequate cleansing or short transit time for the capsule.
• If an adequate cleansing level is not achieved and the total transit time of the capsule is less than 40
minutes related, a repeat evaluation should be considered with the PillCam COLON capsule, or
with alternative diagnostic modalities.
• The capsule should not be swallowed by children under the age of 8 years or patients where a
concern for aspiration of the capsule exists (e.g., due to cognitive or neurological deficits or a
history of aspiration). In these patients, it is recommended that a capsule endoscopic delivery
!
Warning
PillCam capsules are MR unsafe.