The PillCam™ SB 3 capsule is intended for visualisation of the small bowel mucosa and:
May be used in the visualisation and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
May be used in the visualisation and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
May be used in the visualisation and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The PillCam™ SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
Contraindications
Contraindications for PillCam™ SB 3 capsule include:
Patients with known or suspected GI obstructions, strictures or fistulas based on the clinical picture or pre-procedure testing and profile.
Patients with cardiac pacemakers or other implanted electromedical devices.
Patients with dysphagia or other swallowing disorders.
Procedure Risk Information
The risks of PillCam™ SB 3 capsule include capsule retention, aspiration, and skin irritation.
Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
After ingesting the PillCam™ SB 3 capsule, and until it is excreted, patients 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.
PillCam™ Patency Capsule Indications for Use
The PillCam™ patency capsule is an accessory to the PillCam™ capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam™ capsule in patients with known or suspected strictures.
Contraindications
Contraindications for the PillCam™ patency capsule include:
Patients with dysphagia or other swallowing disorders.
Procedure Risk Information
The risks of the PillCam™ patency capsule include capsule retention and aspiration.
Endoscopic placement may present additional risks.
Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
After ingesting the PillCam™ patency capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created near an MRI device.
Passage of an intact patency capsule does not preclude the presence of an intestinal stricture or other pathology.
Please refer to the product user manual for detailed information.
