CapsoVision CapsoCam Plus Mode D'emploi page 7

Warnings
Laser Radiation— Class 1M Laser Do not view
directly with optical instruments
• The capsule should not be swallowed by patients for
whom a concern of aspiration exists (e.g. due to cognitive
or neurological deficits or a history of aspiration). In these
patients, it is recommended that a capsule endoscopic
delivery system be used to place the capsule directly in the
duodenum. Placement of the capsule in the duodenum
will decrease the risk of aspiration of the device [by
vomiting] and gastric retention.
• A patient with known or suspected delayed gastric
emptying (whether disease-related or drug-induced)
could be at increased risk for an incomplete examination.
• Instruct the patient to contact the physician immediately if,
after ingesting the CapsoCam Plus capsule, there is any
abdominal pain, nausea, or vomiting.
• Only one CapsoCam Plus capsule should be ingested at a
time and only after confirmation that no other CapsoCam
Plus capsules remain in the patient' s body.
• If, contrary to instructions, a patient ingests more than one
CapsoCam Plus capsule, instruct the patient to immediately
contact the physician.
Document Number: IFU-2320 Rev: H Revision Date: 8/28/2019
• In patients with unsuspected strictures of the GI tract,
any CapsoCam Plus capsule can potentially cause intestinal
obstruction resulting in the need for hospitalization and
surgery.
• The safety of this device in pregnant women has not been
established.
• The safety of this device in patients with significant
gastrointestinal diverticular disease is unknown.
• Final diagnosis should be made only by physicians who are
trained in the interpretation of capsule endoscopy images.
• The CapsoCam Plus Capsule Endoscopy System needs to
be installed and put into service according to the
Electromagnetic Compatibility (EMC) information provided
in the accompanying documents.
• Patients should avoid biting the CapsoCam Plus capsule
prior to swallowing.
• If the capsule is damaged in any way, including by forceful
biting, the patient should not swallow the capsule.
• If the capsule is not excreted after 72 hours, patient should
contact the physician.
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