Endoscopy systems

PillCam™ SB 3 capsule endoscopy system

<p>The PillCam™ SB 3 capsule endoscopy system 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.</p>

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Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.Medtronic medical devices marketed in Spain are in compliance with the Spanish legislation in force.

Features

The evolution of the PillCam™ system

For more than 20 years, PillCam™ SB 3 has been a pioneer 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.

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.

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.

PillCam™ recorder DR 3

The PillCam™ recorder DR 3 is a recording device with a built-in, real-time viewer, which is worn by the patient during the PillCam™ procedure. Following the procedure, the physician downloads the images from the PillCam™ recorder 3 for interpretation.