Wellspect Navina Smart User manual

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 Smart system.
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. 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 o automatically once the data is
transferred.
6. Rate the new irrigation uploaded in the app.
Settings
Charging Transfer data
Turn on Navina Smart control unit.
The On/o button also indicates
battery charge.
Enter and exit settings.
Select flow rates (up/down).
Select balloon size (+/–).
1Select maximum balloon size. For the small
catheter only settings 1-3 shall be used.
2Select maximum water
volume to instill.
3Select flow rate for button:
4Select flow rate for button:
5Select pin code if desired.
3
3
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 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
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

73210-USX-2021-08-09 © 2021 WELLSPECT. All rights reserved.
36-38 °C
Note: Make sure that the control
unit is charged and parameters
set before starting on this page.
QUICK GUIDE ADULT USE
Preparation & Use
(cone)
Manufacturer Wellspect HealthCare, Aminogatan 1, P.O. Box 14, SE-431 21 Mölndal, Sweden. Phone: [phone].
1. Preparation
1. Fill water to the upper mark of
the container and 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 the water container lid.
2. Disconnect the tubes from control unit.
3. Empty water from the tubes.
4. Turn o the Navina Smart control unit and empty water from the 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 the tube from water container and empty water.
7. Clean and dry the tubing and water container with a cloth
and mild soapy water. The control unit must only be wiped clean.
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.
Transfer data
see instructions on opposite side
4. Evacuation
1. Remove the cone gently
2. Allow bowels to empty. If needed to start
emptying, relax for 10-15 minutes, lean
forward, cough or massage abdomen.
Do not turn o the control unit
3. Instillation
1. Carefully insert the cone, without any force, as you have been instructed
by your healthcare professional. Hold the cone in place during irrigation.
2. Instill water by pressing .
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.
Do not turn o the control unit.
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1.0
2. Activation
1. Turn on the Navina Smart control
unit by pressing .
2. Press any button to go to the activation
mode .
Press and hold to
pump water until the cone is covered with
water (making it slippery) and the and the
icon appears on the screen.
3. Press when you are ready
to insert the cone to proceed
to the Instillation mode.
Note: Do not add additional lubricant.
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Cone
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