CapsoVision CapsoCamPlus Mode D'emploi page 4

Cautions
• Ensure that only personnel who are trained on the
CapsoCam Plus Capsule Endoscope System operating
procedures use the system.
• In a small number of cases, the CapsoCam Plus capsules
may not image the entire small bowel due to variations in
patient GI motility or anatomy.
• The final diagnosis should only be made by physicians
who are trained in the interpretation of capsule endoscopy
images.
Benefits
• The CapsoCam Plus Capsule is a tool for visualization of
the GI tract, specifically the small bowel.
• The system operates without the use of radiofrequency
(RF) transmission, and, therefore, it is not contraindicated
for patients with electronic implantable devices.
• The diagnostic data is stored onboard the capsule,
allowing patients to undergo the procedure without the
need to wear external receiver equipment.
• CapsoCam Plus offers a simple, safe and less invasive
alternative to traditional endoscopic imaging procedures.
• The procedure does not require sedation or radiation.
4
Document Number: IFU-2320 Rev: J Revision Date: 08/2020
Risks
• All medical procedures carry some risks. Information in this
manual should not be used as a substitute for discussions
with healthcare providers about diagnosis and treatment.
• CapsoCam Plus capsule endoscopy is not for every patient.
CapsoCam Plus video capsules are contraindicated in
patients with known or suspected gastrointestinal
obstruction, strictures or fistulas, patients who are pregnant,
patients with gastroparesis and patients with swallowing
disorders.
• Capsule retention, defined as having a capsule remain in the
digestive tract for more than 72 hours, has been reported in
fewer than 2% of all capsule endoscopy procedures.
• Causes of capsule retention cited in the literature include:
NSAID strictures, Crohn' s disease, small bowel tumors,
intestinal adhesions, ulcerations, and radiation enteritis.
• Although each risk has been addressed and mitigated as far
as possible, there is a possibility that the CapsoCam Plus can
fail due to components, hardware, software and packaging
issues which may cause delay of diagnosis, image quality
degradation, incomplete exam, or data corruption.
• The risks of capsule leakage, allergic reaction, biological
contamination, and infection have been addressed and
mitigated as far as possible. There is a possibility that these
can occur if care is not taken in handling the product