User's Manual

PillCam Capsule Endoscopy
6 Warnings
system be used to place the capsule directly in the duodenum. Placement of the capsule in the
duodenum will decrease the risk of aspiration of the device [by vomiting] and gastric retention.
• Examine both video streams when viewing the results of a COLON capsule endoscopy.
• If intestinal fistulas, strictures, or stenosis are suspected, or the patient has had prior abdominal or
pelvic surgery, the physician should consider performing an examination to ascertain patency for an
object the size of the PillCam video capsule.
• A thorough understanding of the technical principles, clinical applications and risks associated with
the PillCam system is necessary before using this product. Read the entire manual before using the
system for the first time.
• To prevent the patient from being exposed to unforeseen risks during passage of any PillCam video
capsule, make sure the patient thoroughly understands the procedure, and provide the patient with a
copy of the Patient Instructions.
• A patient with known or suspected delayed gastric emptying (whether disease related or drug induced)
could be at increased risk for incomplete PillCam capsule endoscopy of the small bowel or colon.
• When swallowing the capsule there is a possibility of choking on the capsule. If the patient exhibits
any symptoms and/or clinical signs of choking (labored breathing, wheezing, involuntary coughing,
etc.), the recommended first-aid procedure should be followed.
• If a child has accidentally swallowed any unused or spent PillCam video capsule, seek medical
attention.
• Instruct the patient not to sit on bare metal surfaces, such as chairs with metal seating area, during the
procedure.
• Instruct the patient to contact the physician immediately if, after ingesting any PillCam video capsule,
there is any abdominal pain, nausea, or vomiting.
• Only one PillCam video capsule should be ingested at a time and only after confirmation that no other
PillCam video capsules or ingestible diagnostic devices remain in the patient’s body.
• If, contrary to instructions, a patient ingests more than one PillCam video capsule, instruct the patient
to immediately contact the physician.
• In patients with unsuspected strictures of the GI tract, any PillCam video capsule can potentially cause
intestinal obstruction resulting in the need for hospitalization and surgery.
• The safety of this device in pregnant women has not been established.
• The safety of this device in patients with significant gastrointestinal diverticular disease is unknown.
• Final diagnosis based on the RAPID video should be made only by physicians who are trained in the
interpretation of capsule endoscopy images.
Product Related:
• If there is reasonable doubt concerning the integrity of the PillCam video capsule due to dropping,
biting, or any other eventuality, the capsule should be deactivated by returning it to its box and it
should not be used until consulting with an authorized Given Imaging representative.
• Store all PillCam video capsules in a safe place, out of the reach of children and infants.
• Do not use any PillCam video capsule after its expiration date.
• Instruct the patient to avoid biting the PillCam video capsule prior to swallowing.