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
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2: INDICATIONS, CONTRAINDICATIONS AND WARNINGS
2.1 Indications
The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small
bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small
bowel.
2.2 Contraindications
The capsules are contraindicated for use under the following conditions:
 In patients with known or suspected gastrointestinal obstruction, strictures, orfistulas
based on the clinical picture or pre-procedure testing andprofile.
 In patients with cardiac pacemakers or other implantable electronic medicaldevice.
 In patients with an easily magnetized metal part.
 In patients with dysphagia or other swallowing disorders.
 In pregnant women.
Note: The Capsule maybe deployed by using transendoscopic delivery in patients who are
unable to ingest the capsule or are known to have prolonged gastric emptying time.
Placement into the duodenum is recommended to prevent the patient from vomiting the
capsule.
2.3 Adverse Events
Potential adverse events associated with the use of a capsule include injury to a patient caused
by delayed excreting or not excreting of capsule, aspiration of the capsule, and interference from
strong magnetic field sources. It could be necessary to remove the capsule by intervention.
2.4 Warnings
 A negative or normal result obtained by the capsule does not exclude the presence of
pathology and if symptoms persist, further evaluation should be performed.
 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 capsule.
 The safety of the capsule has not been established in children.
 The capsule should not be swallowed by patients where a concern for aspiration of the
capsule exists (e.g., due to cognitive or neurological deficits or a history of aspiration). In
these patients, it is recommended that a capsule endoscopic delivery system be used to