User's Manual

NaviCam Small Bowel Capsule Endoscopy System
User Manual P a g e |
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ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1
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.
 A thorough understanding of the technical principles, clinical applications and risks
associated with the Capsule System is necessary before using this product. Read the entire
manual before using the system for the first time.
 Make sure that only trained personnel or professional personnel, familiar with all operating
procedures of the NaviCam SB System, use the system.
 To prevent the patient from being exposed to unforeseen risks during passage of any
capsule, make sure the patient thoroughly understands the procedure, and provide the
patient with a copy of the Patient Labeling.
 A patient with known or suspected delayed gastric emptying (whether disease related or
drug induced) could be at increased risk for incomplete the NaviCam SB System.
 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.
 Keep the capsule away from implants such as pacemakers and other devices that could be
affected by proximity to a DC magnetic field.
 If a child has accidentally swallowed any unused or spent 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 capsule,
there is any abdominal pain, nausea, or vomiting.
 Only one capsule should be ingested at a time and only after confirmation that no other
capsules or ingestible diagnostic devices remain in the patient’s body.
 If, contrary to instructions, a patient ingests more than one capsule, instruct the patient to
immediately contact the physician.
 In patients with unsuspected strictures of the GI tract, any capsule can potentially cause
intestinal obstruction resulting in the need for hospitalization and surgery.
 The safety of this device in patients with significant gastrointestinal diverticular disease is
unknown.
 Final diagnosis based on the capsule images should be made only by physicians who are
trained in the interpretation of capsule endoscopy images.
 If there is reasonable doubt concerning the integrity of the 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 ANKON Technologies representative.
 Store all capsules in a safe place, out of the reach of children and infants.
 Do not use any capsule after its expiration date.
 Instruct the patient to avoid biting the capsule prior to swallowing.
 Instruct the patient to wear the data recorder throughout the procedure.
 After ingesting the capsule and until it is excreted, the patient should not be near any source
of powerful electromagnetic fields such as one created near an MRI device.