User's Manual

NaviCam
®
Stomach Capsule User Manual Page | 11
AnX Robotica Corp. UM-NCES-ST-01 Rev 1
CHAPTER 2: INDICATIONS, CONTRAINDICATIONS AND
WARNINGS
2.1 Indications
The NaviCam Stomach Capsule is intended for visualization of the stomach. The
system can be used in clinics and hospitals, including ER settings.
2.2 Contraindications
NaviCam Stomach Capsule is contraindicated in the following patients:
 Patient with known or suspected gastrointestinal obstruction, stenosis or
fistula.
 Patient implanted with a cardiac pacemaker or other implantable electronic
medical device.
 Patient implanted with an easily magnetized metal part.
 Patient with dysphagia.
 Pregnant women.
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, inhalation, and
interference from strong magnetic field sources. It could be necessary to remove the
capsule by intervention.
2.4 Warnings
Warning is used to suggest risks that may cause dange to patient or operator.

Patient should fully understand the requirements for use of this product and
instructed by the Physician.

Patients should never use two capsules with the NaviCam System.

Patients or practitioners implanted with an electronic device such as a pacemaker
should remain at least 2 meters from the system

The capsule can be swallowed and used only in the presence of authorized
personnel.

Before examination, make sure that all clothes with metal wire or metal parts and
all other metal objects such as watch or coin are removed from the patient.

If there is any concern about the integrity of the capsule, it should not be used
until an authorized representative of AnX Robotica Corp. is consulted. The