CapsoVision CapsoCam Plus Mode D'emploi page 9

and provide the patient with a copy of the Patient
Instructions.
• Do not use CapsoCam Plus after its expiration date.
• When swallowing the capsule, there is a possibility of
choking on the capsule. If the patient exhibits any symptoms
and/or clinical signs of choking (labored breathing, wheezing,
involuntary coughing, etc.), the capsule shall be ingested
under the supervision of authorized medical personnel.
• Used capsules are biologically contaminated and if reused
can cause infection from bacteria, viruses, or other agents.
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.
Cleaning
Retrieved 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. Use a
soft bristle brush (paying special attention to the dimple at
the bottom of the capsule) as necessary to thoroughly
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.
Document Number: IFU-2320 Rev: H Revision Date: 8/28/2019
3. Dry capsule completely.
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.
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 for 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.
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