CapsoVision CapsoCam Plus Mode D'emploi page 8

• Store CapsoCam Plus capsules and their packages in a safe
place, out of the reach of children and infants.
• If a person has accidentally swallowed a CapsoCam Plus
capsule, or the embedded package magnets, seek
immediate medical attention.
• Keep package, including embedded magnet, at least 5cm
(1.9685 inches) away from pacemakers and other
active-implant medical devices.
• Do not modify the capsule without authorization from the
manufacturer.
• Patients should not board an aircraft until the capsule has
been excreted.
• CapsoCam Plus needs special precautions regarding EMC
and needs to be utilized according to the EMC information
provided in this manual.
• Portable and mobile RF communications equipment can
affect CapsoCam Plus.
• The use of accessories, transducers and cables other than
those specified by CapsoVision, Inc. may result in increased
EMISSIONS or decreased IMMUNITY of the CapsoCam Plus.
• CapsoCam Plus should not be used adjacent to
or stacked with other equipment and if adjacent or
stacked use is necessary, CapsoCam Plus should be
observed to verify normal operation in the configuration
in which it will be used.
8
Document Number: IFU-2320 Rev: H Revision Date: 8/28/2019
• A negative or normal result obtained by the CapsoCam
Plus capsule does not exclude the presence of pathology
and if symptoms persist, further evaluation should be
performed.
• If intestinal fistulas, strictures, or stenoses are suspected, or
the patient has had prior abdominal or pelvic surgery, the
physician should consider performing a procedure to
ascertain patency for an object the size of the CapsoCam
Plus capsule.
• After ingesting the CapsoCam Plus capsule and until it is
excreted, the patient should not be near any source of
powerful electromagnetic fields.
• Patients should not have an MRI exam performed until the
capsule has been excreted. Possible patient injury and
medical complications could occur.
• The CapsoCam Plus capsule should not be administered to
patients below two (2) years of age.
• Thorough understanding of the technical principles,
clinical applications and risks associated with the
CapsoCam Plus Capsule Endoscopy 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 the CapsoCam Plus capsule, make
sure the patient thoroughly understands the procedure,