Wellspect Navina Classic Quick Manual

QUICK GUIDE
ADULT USE
(cone)

Intended use

The Navina Classic is intended for transanal irrigation by
instilling water up into the lower part of the colon through a
rectal catheter.

Indications for use

Navina Classic is indicated to help adults and children from 3
years who suffer from fecal incontinence, chronic constipation
and/or time-consuming bowel management. By instilling water
up into the lower part of the colon, the peristaltic muscles in the
bowel can be triggered and start to evacuate the content of the
lower colon and rectum.

Contraindications

Do NOT use Navina Systems if you
have one or more of the following:
• Known anal or colorectal stenosis
• Active inflammatory bowel disease
• Acute diverticulitis
• Colorectal cancer
• Ischemic colitis
• You are within three months of anal or colorectal surgery
• You are within 4 weeks of previous endoscopic polypectomy
As the list may not be exhaustive, healthcare professionals will
always consider individual user factors as well.

Warning!

Seek medical care immediately if you experience severe or
sustained abdominal pain, back pain or rectal bleeding during
or after anal irrigation. Bowel perforation is a very rare (1 out
of 500,000 irrigations or 0.0002 %
complication of TAI. It is a medical emergency and requires
immediate medical attention. Symptoms of bowel perforation
include severe or sustained abdominal or back pain or significant
rectal bleeding (not just smearing of blood on the rectal catheter
which is very common and is not a concern).

Precautions

This product is NOT recommended for:
• Pregnant women
1. Christensen P, Krogh K, Perrouin-Verbe B, et al. Global audit on bowel perforations
related to transanal irrigation. Tech Coloproctol. Feb 2016;20(2):109-115
WELLSPECT does not waive any right to its trademarks by not using the symbols ® or ™.
Note: Read the entire instruction for use. Empty your
bladder before irrigation. Follow the instructions given
by your healthcare professional.
A training session with a healthcare professional specialized
in TAI and familiar with the Navina Systems is mandatory
before using the Navina Classic system.
) yet extremely serious
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Navina Classic control unit
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Overview

1. Connector to the water container
2. Connector to the rectal cone
3. Dark blue pump to instill water
4. Black button to deflate the catheter balloon (N/A)
5. Light blue pump to inflate the catheter balloon (N/A)
6. Switch to open/close water flow
7. Loops to attach the position strap or the lanyard, if desired
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