User's Manual

PillCam Capsule Endoscopy
8 Cautions
Cautions
A caution indicates a condition that may damage the equipment.
• Make sure that only trained personnel, familiar with all of the PillCam Capsule Endoscopy System
operating procedures, use the system.
• Endoscopic video capsule placement requires skill and experience in endoscopic esophageal
intubations with an accessory device seated at the distal tip of the endoscope. Use of the device is not
recommended if the clinician lacks the required experience and proficiency.
• Use the system only with components purchased from Given Imaging Ltd. Use of other components
including power supply for the cradle, may damage the system and void the warranty.
• Occasionally, some images may be lost (less than 3% for COLON 2 and UGI procedures and less than
1% for SB procedures) which results in video gaps (shown as a gray section on the time bar display of
the RAPID video) due to radio interference (e.g., from amateur radio transmitters, RFID (radio-
frequency identification) systems, MRI). This may result in the need to repeat the capsule endoscopy
procedure. In such a case, advise the patient to stay within the premises of the clinic for the duration of
the second capsule endoscopy procedure to prevent this problem from recurring.
• In a small number of cases, the PillCam SB capsules used for Small Bowel Capsule Endoscopy may
not image the entire small bowel due to variations in patient GI motility. Similarly the PillCam
COLON capsule used for COLON Capsule Endoscopy may not image the entire large bowel (colon)
due to variations in patient GI motility.
• Final diagnosis based on the RAPID video should be made only by physicians who are trained in the
interpretation of capsule endoscopy images.
• The Lithium-Ion battery pack in the PillCam recorder DR3 incorporates built-in safety devices. Do not
use the PillCam recorder in a location where static electricity (greater than the manufacturer’s
guarantee) may be present. Otherwise, the safety devices can be damaged, possibly leading to acid
leakage, overheating, smoke emission, bursting and/or ignition.
Benefits and Risks—PillCam Capsule Endoscopy
Benefits
• PillCam capsule endoscopy is the most widely used patient-friendly tool for visualization of the GI
tract. To date, more than 2,000,000 patients worldwide have benefited from PillCam endoscopy.
• PillCam capsule endoscopy provides an alternative for those patients who have had an incomplete
optical colonoscopy with an adequate preparation, and a complete evaluation of the colon was not
technically possible.
• After the patient swallows the PillCam video capsule, images and data are transmitted wirelessly as the
capsule passes through the digestive system. The images are captured and stored in a PillCam recorder
worn by the patient; after the procedure is complete the images are reviewed by a physician.
• The procedure does not require sedation, intubation, bowel insufflation or radiation.
• Patients may continue with their normal daily activity during the procedure.