Operating Range; Operating Environment; Contraindications - CapsoVision CapsoCam Plus Mode D'emploi

Device Common Name
System, Imaging, Gastrointestinal, Wireless, Capsule

Operating Range

Device operates in vivo. Ex vivo it operates within the
following environmental ranges—
Temperature: 5°-40° C
Humidity: 5% to 95%
Atmospheric Pressure: 59kPa to 105kPa

Operating Environment

The intended use environments for CapsoCam Plus are home
healthcare environment, hospital, transport and ambulatory
environments.

Contraindications

The CapsoCam Plus capsule is contraindicated in patients:
• Who have known or suspected gastrointestinal
obstructions, strictures or fistula
• Who are pregnant
• Who have gastroparesis
• Who have a swallowing disorder
Document Number: IFU-2320 Rev: H Revision Date: 8/28/2019
Patient Condition
The physician should consider performing a small bowel
series before utilizing this device in patients who are
suspected to have strictures or fistulas. See Risks on Page 4
for additional risks related to specific patient conditions.
Adverse Events
Potential adverse events associated with the use
of this device may include:
• Obstruction, perforation, and mucosal injury or bleeding.
• Delayed or no excretion of the capsule, and aspiration.
In some instances, intervention is required to remove
the capsule.
Cautions
• Ensure that only personnel, who are trained on all of 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.
• Final diagnosis based on the video images should be
made only by physicians who are trained in the
interpretation of capsule endoscopy images.
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