CapsoVision CapsoCamPlus Mode D'emploi page 8

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.
• 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.
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Document Number: IFU-2320 Rev: J Revision Date: 08/2020
• 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, the physician
should be contacted.
• 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
(2 inches) away from pacemakers and other active-implant
medical devices.