CapsoVision CapsoCam Plus Mode D'emploi page 4

Benefits
• The CapsoCam Plus Capsule Endoscopy System operates
without the use of radiofrequency (RF) transmission. All
of the diagnostic data is stored on board the capsule,
which allows patients to undergo the examination
unhindered by external receiver equipment.
• Due to the lack of RF transmission, patients with an
implantable device can safely ingest the capsule.
• It allows your doctor to examine the small bowel which
cannot be reached by traditional upper endoscopy or
colonoscopy.
• It' s a simple, safe and less invasive alternative to traditional
imaging procedures. The procedure does not require
sedation or radiation. Patients may continue with their
snormal daily activity during the procedure.
Risks
• All medical procedures carry some risks. Information in this
manual should not be used as a substitute for talking with
your doctor about diagnosis and treatment.
• CapsoCam Plus capsule endoscopy is not for everyone.
CapsoCam Plus is contraindicated in patients with known
or suspected gastrointestinal obstruction, strictures or
fistulas, patients who are pregnant, patients with
gastroparesis and patients with swallowing disorders.
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Document Number: IFU-2320 Rev: H Revision Date: 8/28/2019
• Capsule retention has been reported in less than 2% of all
capsule endoscopy procedures. Capsule retention is
defined as having a capsule remain in the digestive tract
for more than 72 hours.
• 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
according to these instructions for use and hospital
procedures, but the probability of occurrence is very low.
• Summaries in published literature identify the risk of
capsule retention to be approximately 1.5% for obscure
bleeding, 1.4% for suspected Crohn' s disease, 5% for
known Crohn' s , and 2.1% for neoplastic lesions. [1], [2].
[1] Cave et al. Endoscopy. 2005; 37: 1065-1067.
[2] Zhuan et al. GI Endoscopy. 2010; 71: 280-286.