CapsoVision CapsoCamPlus Mode D'emploi page 9

• 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.
• 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.
Document Number: IFU-2320 Rev: J Revision Date: 08/2020
• 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, and provide
the patient with a copy of the Patient Instructions.
• Do not use CapsoCam Plus after its expiration date.
• When swallowing the capsule, there is a possibility of choking,
or capsule aspiration. If the patient has any difficulty ingesting
the capsule, the provider may consider placing the capsule
endoscopically. If the patient exhibits any clinical signs of
capsule aspiration (labored breathing, wheezing, involuntary
coughing, etc.), follow appropriate emergency procedures.
• Used capsules are biologically contaminated and if reused can
cause infection from bacteria, viruses, or other agents.
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