Endoscopy systems

PillCam™ SB 3 capsule endoscopy system

<p>The PillCam™ SB 3 capsule endoscopy system is the ingestible camera in a capsule that allows for visualization of the small bowel.</p>

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Indications, Safety, and WarningsPillCam™ SB 3 capsuleIndications for useThe PillCam™ SB 3 capsule is intended for visualization of the small bowel mucosa and:

May be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy

May be used in the visualization 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 visualization 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.

ContraindicationsContraindications for the 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 the PillCam™ SB 3 capsule include capsule retention, aspiration, obstruction, perforation, and mucosal injury or bleeding.

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 capsuleIndications for use

The PillCam™ patency capsule is an accessory to the PillCam™ video capsules and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam™ video capsules in patients with known or suspected strictures.

The PillCam™ patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system.

Therefore, the PillCam™ patency capsule is intended to be used:

Prior to PillCam™ SB capsule in adults and children from two years of age, or

Prior to PillCam™ UGI, COLON, and Crohn’s capsules in adults

ContraindicationsContraindications for the PillCam™ patency capsule include:

Patients with 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.

Features

The evolution of the PillCam™ system

For 20 years, the PillCam™ capsule endoscopy system has been a leader in providing physicians with tools that may help them visualize and monitor lesions. These lesions may indicate or be a source of conditions such as Crohn’s disease, obscure bleeding, or iron deficiency anemia not detected by upper and lower endoscopy.

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The PillCam™ Genius SB Kit features the PillCam™ Genius link device, the first wearable device used for capsule endoscopy. The PillCam™ Genius link device is a single-use device intended for storing images received from the PillCam™ Genius SB capsule, sending commands to the PillCam™ Genius SB capsule, and providing notifications to the patient while adhered to the patient’s body.¹

See PillCam™ Genius SB capsule endoscopy kit

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Discover the PillCam™ SB 3 capsule endoscopy system components.

PillCam™ SB 3 capsule

PillCam™ SB 3 capsule is a camera inside a capsule that captures images at a frame rate of two to six frames per second (fps) based on capsule speed as it travels through the small bowel.