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
 Undergoing an MRI while the capsule is inside the patient's body may result in serious
damage to his/her intestinal tract or abdominal cavity. If the patient did not positively verify
the excretion of any capsule from his/her body, he/she should contact the physician for
evaluation with the Locator and possible abdominal X-ray before undergoing an MRI
examination.
 A capsule should be ingested only in the presence of authorized medical personnel. The
patient should be instructed not to let relatives, neighbors or acquaintances use any
capsule without medical attention.
 If excretion of the capsule from the patient has not been positively verified, and the patient
develops unexplained post-procedure abdominal pain, vomiting, or other symptoms of
obstruction, he/she should contact the physician for evaluation with the Locator and
possible abdominal X-ray examination.
 Use the system only with components purchased from ANKON Technologies. Use of other
components may damage the system and void the warranty.
 In a small number of cases, the capsules may not image the entire small bowel due to
variations in patient GI motility.
 After ingesting the capsule, the patient should abstain from eating or drinking for another 2
hours. After 2 hours, the patient may drink water. After 4 hours, the patient may have a light
snack. After the examination is completed, the patient may return to a normal diet. These
instructions related to eating apply unless physician instructs otherwise.
 The inspection will last for about 8 hours. The physician should instruct the patient when
the examination is considered complete. During the examination, the patient should avoid
any physical activity that involves sweating and to abstain from bending. The Data Recorder
should be treated with utmost care and protection. Sudden movement and banging of the
Data Recorder should be avoided. The patient should be instructed not to remove the Data
Recorder during the examination.
 The patient may take his/her usual prescribed medication up until two hours before the
examination and resume two hours after capsule ingestion, with water.
 If the patient is taking any medication that may delay gastric emptying, consider
withholding the drug on the day of the test if this is medically acceptable.
 The capsule is for single use only.
 Even if other devices meet corresponding national emission standards, the system may still
be interfered.
 The battery of the Data Recorder is not removable, and incorrect replacement will lead to
unacceptable risks. Unauthorized personnel are prohibited to replace the lithium battery in
the equipment.
 The users shall not disassembled/modified the Vest/Examination cloth as well as any
connection cable by themselves