Wellspect Navina Smart Instructions For Use

QUICK GUIDE
ADULT USE
Charging & Settings
(cone)
Intended use
The Navina Smart is intended for transanal irrigation by
instilling water up into the lower part of the colon through
a rectal catheter.
Indications for use
Navina Smart 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
Charging
1. Plug the cable into the power adapter
2. Plug the power adapter into a power supply
3. Plug the cable into the Navina Smart control unit
Please note: Charge the Navina Smart control unit fully
before first use. The power adapter must not be used in
the bathroom or with water
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 ™.
) yet extremely serious
1
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 Smart system.
Settings
3
3
Transfer data
1. Turn on the Navina Smart control unit and stay on the welcome page.
2. Open the Navina Smart app.
3. The first time, you will have to confirm the control unit identity to pair
it with your app.
4. Select Synchronize in the app's main menu.
5. The Navina Smart control unit will be turned off automatically once the data is
transferred.
6. Rate the new irrigation uploaded in the app.
Turn on Navina Smart control unit.
The On/off button also indicates
battery charge.
Enter and exit settings.
Select flow rates (up/down).
Select balloon size (+/–).
1
Select maximum balloon size. For the small
catheter only settings 1-3 shall be used.
2
Select maximum water
volume to instill.
3
Select flow rate for button:
4
Select flow rate for button:
5
Select pin code if desired.