PillCam™ COLON 2 Capsule

Indications

• The PillCam Capsule Endoscopy System with the PillCam COLON capsule is intended for the visualization of the colon for diagnosis of colonic disorders.
• The PILLCAM™ COLON capsule is intended for use in adults and children from 8 years of age.
  

Contraindications

The PILLCAM™ COLON 2 video capsule is contraindicated for use under the following conditions:

• In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
• In patients with cardiac pacemakers or other implanted electromedical devices.
• In patients with swallowing disorders.

Note: The procedure may involve intake of laxatives and prokinetic agents. Refer to the labeling of these agents for their contraindications.

Procedure Risk Information

• The risks of PillCam™ COLON 2 capsule include capsule retention, aspiration and skin irritation.
• The risks associated with colon preparation are allergies or other known contraindications to any preparation agents or medications used for the PillCam™ COLON 2 regimen, according to laxative medication labeling and per physician discretion.
• Medical, endoscopic or surgical intervention may be necessary to address any of these complications, should they occur.
• After ingesting the PillCam™ COLON 2 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.
• Please refer to the product user manual for detailed information.