Wellspect Navina Classic User manual

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.
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 suer 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 %1) yet extremely serious
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
WELLSPECT does not waive any right to its trademarks by not using the symbols ® or ™.
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
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

1. Preparation
1. Fill water to the 0-mark of the container. Close the lid.
2. Connect the water container tube between water container and control unit (dark blue).
3. Connect the cone tube between control unit and cone (light blue/white).
Note: Follow colour coding and symbols. Use luke warm and clean water only.
Make sure the safety valve on the lid is not blocked during the procedure.
5. Disassembly
1. Open water container lid.
2. Disconnect tubes from control unit.
3. Empty water from tubes.
4. Open water flow and empty water from control unit.
5. Disconnect the single use cone and dispose as household
waste. It must not be reused and not flushed down the toilet.
6. Disconnect tube from water container and empty water.
7. Clean and dry the tubing, water container and
control unit with a cloth and mild soapy water.
Note: Tick a box in the usage calendar (see instructions for use) after each
use to keep track of when to exchange the water container and tube set.
2. Activation
1. Make sure water flow is opened .
2. Pump water with the dark blue pump until
it covers 3/4 of the cone, making it slippery.
3. Close water flow .
Note: Do not add additional lubricant.
4. Evacuation
1. Remove cone gently.
2. Allow bowel to empty. If needed to start
emptying, relax for 10-15 minutes, lean
forward, cough or massage abdomen.
3. Instillation
1. Carefully insert the cone, without any force, into the rectum, as fas as instructed by your
healthcare professional. Hold it in place during the procedure.
2. Open water flow .
3. Instill the water volume, as indicated by your health care provider, using the dark blue pump.
Stop or pause the instillation at any time by releasing the pump and closing the water flow.
4. Close water flow .
Note: Never insert cone with force. If experiencing resistance, remove
cone, and follow instructions for use trouble shooting section. If resistance
continues, stop using irrigation and seek help from a health care professional.
73214-USX-2020-03-31 © 2020 WELLSPECT. All rights reserved.
QUICK GUIDE ADULT USE
Preparation & Use
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Wellspect HealthCare, Aminogatan 1, P.O. Box 14, SE-431 21 Mölndal, Sweden. Phone: [phone].
Manufacturer
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