CapsoVision CapsoCamPlus Mode D'emploi page 10

Storage
Store the CapsoCam Plus capsule under normal indoor
environmental conditions. Do not remove the CapsoCam Plus
capsule from the packaging until just prior to use.
Handling of excreted and retrieved
CapsoCam Plus capsules
Physician should provide instructions to the patient for
returning the capsule to the clinic or office, or provide a
prepaid mailing envelope for the retrieved capsule to be
mailed directly to a download center where the capsules will
be processed..
Cleaning of excreted CapsoCam Plus
capsules
Returned capsules should be handled with gloves and
cleaned and disinfected as follows:
1. Clean the capsule using ENZOL® Enzymatic Cleaner (or
equivalent) according to the manufacturer' s instructions,
thoroughly scrubbing the capsule with a soft bristle brush
(paying special attention to the dimple at the bottom of
the capsule) as necessary to remove all debris.
2. Disinfect the capsule using Revital-Ox™ Resert® High
Level Disinfectant (or equivalent) and rinse thoroughly,
according to the manufacturer' s instructions.
3. Dry capsule completely.
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Document Number: IFU-2320 Rev: J Revision Date: 08/2020
Data Download at Clinic
Prior to downloading data from the used capsule, it must
be cleaned, disinfected, and dried. See the CapsoView®
Instructions for Use for downloading instructions.
Disposal
Dispose of capsule and packaging as per local ordinances.
Warranty
CapsoVision warrants that this capsule is free from defects in
both materials and workmanship. Suitability for use of the
capsule functionality for any procedure shall be determined
by the user. CapsoVision shall not be liable for incidental or
consequential damages of any kind. The above warranties
are in lieu of all other warranties, either express or implied,
including any warranty of any merchantability or fitness f
or use.
Essential Performance
Data integrity during image capture and download, laser
Class 1M, and single-use are considered to be the essential
performance of the CapsoCam Plus capsule.
Federal Communication
Commission (FCC) Compliance
The CAPSOVISION system (CapsoCam Plus) complies with
Part 15 of the United States FCC rules and with international
standards for electromagnetic compatibility regarding its use.