Instructions for use
When the bowel works, life works
Navina Smart personal information
Navina Smart control unit:
Code to unlock settings:
–
–
Start date:
Expected date for new control unit:
Water container start dates:
15 uses
Tubes set start dates:
1
2
3
4
5
6
1
7
8
9
10
11
12
2
13
14
15
16
17
18
3
19
20
21
22
23
24
4
Personal recommendations from healthcare professional:
TAI frequency:
TAI day and time:
Balloon size:
Recommended
Maximum
Yes
No
Water volume:
Water flow rate:
Navina Smart app:
Bowel medications
(name, dose and frequency):
Other information:
Contact tel #:
Next follow-up visit:
2
100 uses
IMPORTANT INFORMATION:
Please charge your Navina Smart
control unit when you receive it or
at the latest by the date found on
).
the customer box label (
See instruction page 14.
Table of contents
Navina Smart personal information ........................................................................ 2
Table of contents ...................................................................................................... 3
Thank you for choosing Navina Systems ................................................................. 4
Important safeguards .............................................................................................. 7
Component list ......................................................................................................... 9
Navina Smart control unit ...................................................................................... 11
Instructions for use .................................................................................................. 16
Accessories ........................................................................................................... 28
Frequently asked questions (FAQ) ....................................................................... 30
Troubleshooting .................................................................................................... 36
Signs and symbols ................................................................................................. 39
Warranty ................................................................................................................40
Technical specification – Navina Smart system ..................................................... 41
Quick guide ............................................................................................................47
We value your opinion........................................................................................... 50
Contact information ................................................................................................ 51
Navina Systems ..................................................................................................... 52
Doc. No. PD-2921-H Revised November 14th, 2016
3
Thank you for choosing Navina Systems
Wellspect HealthCare is proud to present Navina™ Systems – A new and smarter way of
benefiting from transanal irrigation (TAI). Navina Systems has been developed in close
cooperation with users and healthcare professionals, to facilitate TAI and make it available
for more people, with different needs. The objective of the treatment is to create a bowel
management routine which will facilitate your lifestyle and for many dramatically reduce
the time and energy spent on bowel management.
Much of the information regarding TAI in this instruction for use, is based on discussions with
healthcare professionals, experts in the TAI field, as well as the article “Consensus review
of best practice of transanal irrigation in adults” (Emmanuel AV et al. Spinal Cord (2013),
1-7. www.nature.com/sc).
Navina Systems
Navina Systems – a complete TAI system for easy learning, usage and follow-up
The Navina Systems comprise of Navina™ Smart and Navina™ Classic, a comprehensive
educational program for healthcare professionals and users as well as the Navina Smart app
– an application for mobile devices. We understand that TAI treatment is very individual and
demands patience while your body adapts to the therapy and your optimal personal settings
are found (for some it may take 4-12 weeks). This is why all the systems elements work together
to facilitate the successful introduction of TAI. Navina Smart has an electrical control unit
which documents your TAI treatments. Your data can be transferred to and analyzed by the
Navina Smart app. This unique follow-up tool will help you and your healthcare professional
to implement a good bowel routine. This is what we like to call smart TAI. When we talk
about smart TAI, we mean TAI using Navina Smart. The classic TAI is performed with
Navina Classic. The Navina Classic is fully manual-controlled. The Navina Smart and
Navina Classic control units are interchangeable to allow personalized solutions for each
unique individual.
Transanal irrigation (TAI)
The TAI treatment instills water into the colon to promote evacuation of the contents of the
lower colon and rectum. Water is instilled through a catheter with an inflatable balloon which
is inserted into the rectum (back passage). The Navina Systems can be used at home, away
from home, whilst travelling or in a healthcare setting. TAI with Navina Systems should be
carried out while sitting on the toilet.
4
Training with healthcare professionals
Navina Smart and Navina Classic should always be handled with utmost caution. Training
sessions in smart TAI with a healthcare professional are mandatory before using the Navina
Smart on your own. After adequate training and recommendations from your healthcare
professional, you should be able to handle the Navina Smart on your own or with your carer
if required. The frequency of treatment varies between individuals and will be recommended
by your healthcare professional. It is usual to start using TAI on a daily basis for the first 10-14
days. Gradually you and your bowel will get used to the treatment and then the TAI procedure
frequency may possibly be reduced to every second or third day.
Indications/who can use Navina Systems
Navina Systems from Wellspect HealthCare are developed to help adults who suffer from fecal
incontinence, chronic constipation, and/or time consuming bowel management. The user may
be wheel chair bound and/or have reduced motoric hand function. 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 colon and rectum.
Contraindications
You should not use Navina Smart or Navina Classic system if you have one or more of the
following:
• Known anal or colorectal stenosis
• Active inflammatory bowel disease.
• Acute diverticulitis.
• Colorectal cancer.
• Ischemic colitis.
• Within three months of anal or colorectal surgery.
• You are within 4 weeks of previous endoscopic polypectomy.
As the list of contraindications may not be exhaustive, healthcare professionals
will always consider individual user factors as well.
Precautions
Always consult a healthcare professional specialized in TAI before using Navina Systems.
This product is NOT recommended for:
• Children.
• Pregnant women.
Special care must be taken if you have or have had any of the following:
• Fecal impaction – If you are heavily constipated an initial clean out of your bowel must be
performed before starting the irrigation treatment.
• Painful anorectal conditions – any condition which may cause pain or bleeding, e.g. anal fissure, anal
fistula third or fourth grade of haemorrhoids.
5
• Severe diverticulosis or diverticular abscess.
• Irradiation therapy in the abdominal or pelvic region.
• Previous anal or colorectal surgery.
• Previous major pelvic surgery.
• Severe autonomic dysreflexia.
• Changed stool pattern such as sudden diarrhea. The cause of diarrhea must be identified.
• Increased risk of hemorrhage or using anticoagulant therapy (not including aspirin or clopidogrel).
• Long term corticosteroid therapy.
• Rectal medication, since the effect of the medication may be changed by using anal irrigation.
Warning
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).
Training and education for healthcare professionals and users
For more information, educational and training material about Wellspect HealthCare,
Navina Smart and Navina Classic, please call Wellspect HealthCare customer service
(see contact information page 51) or visit www.navinasystems.com.
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.
6
Important safeguards
Read all instructions before use
These instructions are only a reminder and should be seen as complementary to what
your healthcare professional has told you. They do not replace the need for training
with a healthcare professional.
Product
• Only use Navina Smart for its intended use, as described in this instruction manual.
• The rectal catheter is a single-use product. If reused, Wellspect HealthCare cannot
guarantee the functionality nor the safety of the product. Reuse may lead to infection.
• Navina Smart is for a single user and should not be shared by other people.
• A training session with a healthcare professional specialized in TAI and familiar
with the Navina Systems is mandatory before using the Navina Smart system.
• Careful medical history and a digital rectal examination are mandatory.
• In the case of previous anal, colorectal or pelvic surgery, an endoscopy or comparable examination
should be performed to exclude other additional disorders that would contraindicate the use of TAI.
• The first irrigation should be performed under supervision of a healthcare professional.
• If you are at risk of autonomic dysreflexia (individuals with spinal cord injury above
the sixth vertebra), supervised first irrigation with close follow-up is mandatory.
• Bowel perforation is a very rare (1 out of 500,000 irrigations or 0.0002 %1) but a very serious and
potentially lethal complication to anal irrigation that requires immediate medical care, hospitalization,
and often surgery. Seek medical care immediately if you experience severe or sustained abdominal
pain, back pain or anal bleeding during or after anal irrigation.
Electricity
When using electrical devices, basic safety precautions should always be followed:
• Make sure to charge the Navina Smart control unit by the latest
date indicated on the package label and at least once a year.
• Make sure the voltage of the charger is compatible with the power source.
• Always unplug electrical devices immediately after use.
• Keep the charger and the power cable away from heated surfaces.
• Never operate an electrical device if it has a damaged power cable or plug,
if it is not working properly and/or if it has been damaged or dropped into water.
• Do not spray or pour liquid directly onto the charger.
• Do not use the charger outdoors.
• Do not use the charger in the bathroom.
• Do not connect the charger to any other equipment than the supplied power adapter.
• Use only the accompanying charger, charging support and power adapter to charge
Navina Smart control unit.
• If you have a pacemaker or other implanted device, consult your doctor or the manufacturer
of the implanted device before using the charger.
7
Use
• Do not store the Navina Smart system’s components in direct sunlight.
• Only use Wellspect HealthCare’s original accessories.
• Check all components for wear or damage before usage. Do not use if damaged.
• There are no user-serviceable parts inside the Navina Smart control unit.
Do not attempt to repair the Navina Smart control unit yourself.
• Make sure to connect the tubes following the instructions, color coding and symbols.
• Make sure the tubes are not blocked.
• Make sure the safety valve on the water container lid is not blocked.
• Make sure to personalize your settings in the Navina Smart control unit
following your healthcare professionals recommendation.
• Make sure to insert the catheter to the handle to ensure the balloon is inflated
at the right place inside your rectum. Do not insert the handle into your rectum.
• Make sure the balloon is deflated before removing the catheter.
• Never insert the catheter with force. If you experience resistance, follow the steps
in the troubleshooting section.
• Do not turn off the Navina Smart control unit during irrigation! The Navina Smart control unit
should not be turned off until all tubes are disconnected! As long as the Navina Smart control unit
is on, it prevents a backflow of water from the rectal catheter into the tubes.
• If you have impaired sensation in your anal area and you wish to use the grip rings,
make sure your healthcare professional shows you where the ring should be placed
on the tube in order to insert the catheter to its handle and no further.
• Store the Navina Smart system away from the reach of small children. Supervise children if they are
in proximity of the Navina Smart system to avoid risk of strangulation with the tubes and suffocation
with the plastic bag or in the event that small components get loose from the product.
Keep this instruction for use for further reference.
8
Component list
3
4
2
5
6
1
7
Accessory set
8
9
10
10
11
Navina tube set
Navina water container
Navina catheter
Navina Smart control unit
9
Navina Systems component lifetimes
Warning: If the components are used more times or for a longer period than indicated in the table below,
Wellspect HealthCare cannot guarantee the functionality nor the safety of the product.
#
Product
REF
1.
Navina Smart
instructions for use
2921
2.
Navina Smart
control unit
68745
400 uses or 2 years from
the date of the first use,
whichever comes first
1
3.
Charger, charging support
and power adapter
5194
400 uses or 2 years from
the date of the first use,
whichever comes first
1
4.
Navina tube set
68747
100 uses. Tubes can be
ordered separately
Household waste
5.
Navina water container
68742
15 uses
Household waste
6.
Navina catheter regular
68940
The rectal catheter is
single use only
Household waste
7.
Navina case
2844
Household waste
8.
Navina positioning strap
69012
Household waste
9.
Navina Smart control
unit positioning clip
69012
Household waste
10. Navina grip rings
69012
Household waste
11. Navina lanyard
69012
Household waste
1
Lifetime
Disposal
Household waste/
paper recycle
This product contains recyclable materials. Do not dispose this product as unsorted municipal waste.
Please contact your local municipality for the nearest collection point. For Europe: Separate disposal
for electrical and electronic waste according to the Waste Electrical and Electronic Equipment
(WEEE Directive).
Note: the components of the Navina Smart system are not manufactured with latex. All components
of the Navina Smart system, with the exception of the charger cable and the wire insulation
inside the Navina Smart control unit, are not manufactured with PVC and phthalates.
10
Navina Smart control unit
The Navina Smart control unit will make it possible to personalize your smart TAI routine to
make your management convenient and consistent. By setting the unit parameters together
with your healthcare professional, and entering your personal maximum settings, the unit
will function safely in order to suit your own bowel habits.
The buttons on the Navina Smart control unit respond to touch, this means that water flow
will stop when the button is released. As a safety feature, if the Navina Smart control unit is
switched off the water pump will stop and the balloon will deflate automatically.
This will give you full control through the whole TAI procedure. Read the instructions carefully and keep this manual close to hand.
Overview
1
1.
Connector to the water container
2.
Connector to the rectal catheter
3.
On/off
Note: The on/off and Settings buttons must be held a little
while before they respond. This is to avoid the possibility to
turn off or enter settings by mistake.
4.
Settings
5.
Instillation of water button 1 (in setting mode: Step down)
Note: Two Instillation of water buttons are available and can
be set, after discussion with your healthcare professional,
according to your own personal needs. This will give you the
possibility to use two different water flows during an irrigation
without having to enter the setting mode.
6.
Instillation of water button 2 (in setting mode: Step up)
7.
Inflation of balloon (in setting mode: Increase values +)
8.
Deflation of balloon (in setting mode: Decrease values – )
9.
Loop to attach the lanyard for hands-free handling
2
4
3
10
1.0
4
6
7
5
8
10. Display (blue during activation, white during TAI)
9
Additional feature – automatic bowel diary
You can keep record of your TAI treatments by downloading the free Navina Smart app on the
App Store or Google Play. The Navina Smart app will automatically compile a bowel diary
for you with data from the Navina Smart control unit, let you evaluate the TAI sessions,
present the data to facilitate the identification of your optimal personal settings and easier
follow-up with your healthcare professional if you should so desire.
11
Overview display
To save power the display will go on power save mode when no buttons have been activated for five minutes (the blue light at the on/off button will flash slowly to indicate the
power save mode). To re-activate the display press
. After 75 minutes on power save
mode the Navina Smart control unit will automatically turn itself off.
There are four main modes/screen types on your Navina Smart control unit.
Welcome page/data transfer
mode
1
This is the only mode where
your data can be transferred
1.
2.
3.
4.
Battery level
Software version
Serial number
Bluetooth®
2
to the Navina Smart app if
you wish to use it. Bluetooth®
is only active when you are
in data/transfer mode.
3
4
Setting mode
This mode allows you to personalize your Navina Smart control unit and select maximum
settings for increased convenience and safety.
Note: When using Navina Smart you can always choose to stop the irrigation before you reach
the maximum settings. You are always fully in control.
4
4
1.0
1.0
1.0
Note: For safety purpose, to be able to
change the rectal catheter maximum
balloon size setting, the balloon must
be completely deflated.
Select the parameter with
/
(up/down).
Select the level with
/
(+/-).
12
If you enter the setting mode while
the catheter balloon is inflated, the
maximum catheter balloon setting
will not be displayed.
Activation mode
1
In this mode you empty the
air from the system and acti-
1.
2.
3.
4.
Battery level
Max amount of water
Max size of balloon
You can enter instillation mode
by pressing the balloon deflation
button
1.
2.
3.
4.
5.
6.
Battery level
Max amount of water
Max size of balloon
Actual flow rate
Actual balloon size
Amount of water instilled
vate the hydrophilic surface
on the catheter.
For safety reasons, the
Navina Smart control unit
4
1.5
3
must register water flowing
through the control unit
before you can proceed to
4
2
instillation mode.
Once the control unit has
registered water flow, the
balloon deflation button
will appear at the bottom of
the screen (4) to remind you
that you can press it to go to
instillation mode.
Instillation mode
This mode is used during
the actual irrigation.
1
4
5
4
2
3
6
Get started
The Navina Smart control unit is in a battery saving mode when delivered. To activate the
Navina Smart control unit you must place it on charger for a few seconds.
For convenience, the control unit is partly charged and the power should last for a least one
irrigation. We recommend however that you charge the Navina Smart control unit fully
before use.
Note: Your first irrigation should be supervised by a healthcare professional.
13
Charging the Navina Smart control unit
The Navina Smart control unit comes with an inductive charger and a charging support that
fits the Navina Smart control unit. You should place the inductive charger in the charging
support as shown in the illustration below.
The Navina Smart control unit uses inductive, or wireless,
charging which means that there are no electrical connections into the Navina Smart control unit. Plug the power
adapter cable into the charger and place it on a flat surface.
Note: Make sure the logotype on the charger is facing the front and
the connection for the power cable is to the left.
1. Place the inductive charger unit in the charging support.
2. Plug the power adapter into the mains socket.
3. Plug the power adapter cable into the charger.
4. Place the Navina Smart control unit on the charging support.
When the Navina Smart control unit is on the charger, the display will go on power save
mode and the blue light indicator on the on/off button will let you know how the charging
is proceeding. If there is not enough power for one complete irrigation, the blue light will
flash once every 4 seconds. Once the Navina Smart control unit has enough power to perform at least one complete irrigation, the blue light will flash twice every 4 seconds. When
the unit is fully charged, the blue light will be lit continuously.
A fully charged battery should last for at least 6 irrigations. As your irrigation regime is personal, the number of irrigations you can perform with a fully charged Navina Smart control
unit may differ for you. The Navina Smart control unit will not start if there is not enough
battery power to perform at least one complete irrigation. For better battery performance
you should not charge the control unit after each irrigation but rather wait until the battery
symbol
light is red. To fully charge the battery takes approximately 7 hours. Charging
for one irrigation should take approximately 1 hour. The Navina Smart control unit cannot
be used during charging. The charger must not be used in the bathroom.
When cleaning the charger, use only a moist soft cloth.
Never flush the charger parts with water.
WARNING: Only use the supplied charger to with the Navina Smart control unit.
14
Setting your Navina Smart control unit.
. The display of the Navina
1. Press the on/off button
1
Smart control unit will light up and a welcome screen is seen.
The first time you turn on your Navina Smart control unit,
you will after a few seconds be automatically redirected to
setting mode. Otherwise to enter the setting mode press
.
0.1
Note: As a safety precaution the factory settings on the Navina
Smart control unit are set very low. You will need to personalize
the settings together with your healthcare professional.
2. Set the size of the inflated balloon (1-5).
1
The catheter balloon is inflated in 5 separate steps.
Balloon size diameter (in mm)
1
2
3
4
5
31,5 ± 5
40,5 ± 5
49 ± 5
57 ± 5
65 ± 5
Note: These diameters reflect the size of the balloon when inflated outside the bowel. When the balloon
is inflated inside the bowel, it will adapt its shape and the diameter can differ slightly.
3. Set the amount of instilled water (0.1-1.5 liter).
The amount of water can be set in steps of 0.1 l. Usually a
0.1
TAI procedure for an adult will use 0.5-1.0 l.
4. Set the flow rate for button 1 (1-5).
The factory setting for the
button is 275 ml/min
(1 in the 1-5 scale).
Water flow (ml/min)
1
2
3
4
5
275 ± 50
375 ± 50
500 ± 50
600 ± 50
700 ± 50
5. Set the flow rate for button 2 (1-5).
The factory setting for the
button is 375 ml/min
(2 in the 1-5 scale).
Water flow (ml/min)
1
2
3
4
5
275 ± 50
375 ± 50
500 ± 50
600 ± 50
700 ± 50
Note: The flow rates above represent default conditions outside the bowel, i.e. where the water
container is placed 50 cm below the rectal catheter. The actual flow rate during irrigation, will be
shown on the display above the catheter. The flow rate on the display shows the water flow in l/min.
15
Instructions for use
Note: Read the entire instruction. Empty your bladder before irrigation.
Follow instruction of your healthcare professional.
Overview
1. Charging
2. Setting
3. Preparation
4. Activation
1. Place the inductive
charger unit in the
charging support.
1. Enter settings by
.
pressing
1. Fill water container.
1. Turn on the Navina
Smart control unit by
.
pressing
2. Plug the power adapter
into the mains socket.
3. Plug the power adapter
cable into the charger.
4. Place the Navina Smart
control unit on the
charging support.
2. Connect the water
container tube between
water container
and control unit (dark
blue).
2. Select maximum
balloon size.
3. Select maximum water
volume to instill.
3. Connect the catheter
tube between control
unit and catheter (light
blue/white).
4. Select flow rate for
.
button 1
5. Select flow rate for
.
button 2
6. Select pin code if
desired.
2. Press any button to go
to the activation mode
/
/
/
(
).
3. Press
/
to pump water until
the catheter tube is
covered.
when you
4. Press
are ready to insert the
catheter to proceed
to the Instillation mode.
7. Exit setting by pressing
.
WARNING: No modification of this equipment is allowed
Note: A training session with a healthcare professional specialized in TAI and familiar with the Navina
Systems is mandatory before using the Navina Smart system. Make sure you have chosen your personal
settings. These settings will set the maximum values to which you can inflate the balloon and instill
water.
16
5. Instillation
6. Evacuation
7. Disassembly
8. Transfer data
1. Insert the rectal catheter to the handle.
Note: do not turn off
the control unit until the
disassembly stage.
1. Open water container
lid.
1. Turn on Navina Smart
control unit and stay on
welcome page.
to inflate the
2. Press
catheter balloon until
the desired balloon
size is reached.
3. Gently pull catheter
slightly down to seal
the rectum.
2. Disconnect tubes from
control unit.
to deflate
1. Press
the balloon.
3. Empty water from
tubes.
2. Remove catheter.
3. Allow bowels to empty.
4. Turn off the Navina
Smart control unit
and empty water from
control unit.
4. Instill water by pressing
/
.
5. Disconnect catheter
and dispose in household waste.
6. Disconnect tube from
water container and
empty water.
7. Rinse, clean and dry
system.
2. Open 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
main menu in the app.
5. The Navina Smart
control unit will turn
itself off automatically
once the data is transferred.
6. Rate the new irrigations
uploaded in the app.
Note: Fecal impaction should be excluded and treated before starting TAI. If you suffer from constipation,
the efficiency of TAI may be improved by having a clear colon before you start with the TAI therapy.
Furthermore, your healthcare professional might want to optimize your stool form by adapting your
diet or with the use of laxative medication.
17
Preparation
1. Open the lid and unwrap the water container by releasing the handle and expanding the
container. Fill the container with lukewarm clean water to the upper mark of the container.
97-100°F
36-38 °C
Note: It is much easier to expand the water container when the lid is open.
Note: Always fill the container to the upper mark! You may not use all of the water during TAI, but a
full container will make it easier to create pressure within the Navina Smart system and allow you to
use the inverted scale to see how much water you have instilled in your body.
Note: Always use lukewarm water. Water that is too cold can be unpleasant and you may experience
cramps. Water that is too hot may irritate the delicate lining in your rectum and colon.
2. Gently close the lid of the container until your hear/feel a “click” (different ways of doing
this are illustrated below).
IMPORTANT: Make sure that the safety valve on the lid is not blocked during the whole TAI procedure.
Note: You can place the container wherever is most convenient for you during the TAI procedure;
standing on the floor, hanging by the handle or placed on a shelf or in the sink.
18
3. Connect the tube with dark blue connectors to the dark blue
connector on the water container. Lock the connection by
turning it clockwise until it stops.
Note: If you plan to hang the water container, be sure to place the
handle behind the tube.
Note: All the Navina Smart connections are designed to be easy to
assemble. You do not need to align the tube and connection holes
exactly. By turning the tube the initial connection will be made
when the holes are aligned. When you push the tube in place, the
connection will hold so that you can twist and lock the connection
to complete stop.
4. Remove the protective caps the first time you use
the Navina Smart control unit.
5. Connect the tube with dark blue connector to the dark
blue connection and the
symbol on the Navina Smart
control unit. Lock the connection by turning it clockwise
until it stops.
6. Connect the tube with the light blue connector to the light
blue connection and the
symbol on the Navina Smart
control unit. Lock the connection by turning it clockwise
until it stops.
19
7. Peel the catheter packaging open 2-3 cm to expose the rectal catheter connection. Do not
remove the catheter from the packaging at this stage. Attach the tube with the white connection to the catheter. Lock the connection by turning it clockwise until it stops.
Note: Don’t open the packaging too far, as it will later be filled with water to activate the hydrophilic
surface of the catheter. The hydrophilic surface is the coating on the catheter. It attracts water, which
makes the catheter slippery. Do not use gel on the catheter.
Note: The catheter connection is half-moon shaped to help you connect it correctly.
8. Attach the packaging to a vertical surface by the adhesive patch or place it in the sink
or in a tall glass. This way, the incoming water will remain in the package itself and the
hydrophilic surface on the catheter will be activated. Ensure that the placement of the
catheter is within easy reach when you are sitting on the toilet.
20
Activation (of the hydrophilic surface of the catheter)
1. Turn on the Navina Smart control unit by pressing the on/
off button
. The blue light will indicate that the device
is on. The display will show the welcome screen. Press
to enter activation mode: showing the water container
and the catheter pointing down in its packaging on a blue
background. To empty the tubes of air and activate the
slippery surface on the catheter, press and hold
or
.
Water will pour into the catheter packaging and activate the
hydrophilic surface of the catheter. Release the button when
the water has reached ¾ of the length of the catheter. Once
you are ready to insert the catheter, press
to proceed to
the instillation mode.
Note: The hydrophilic coating on the catheter is activated
immediately and is ready to use.
Note: For safety reasons, the Navina Smart control unit must
register water flowing through the control unit before you can
proceed to instillation mode.
Once the control unit has registered water flow, the balloon deflation button will appear at the bottom of the screen (4) to remind
you that you can press it to go to instillation mode.
Note: The system allows a maximum of 200 ml of water to
activate the catheter.
21
1.0
4
Instillation
1. Insert the rectal catheter. Remove the catheter from its
packaging. Keep the package for the disposal of the catheter.
As instructed by your healthcare professional, hold the
catheter’s handle and insert the activated catheter carefully
into your rectum so that your fingers and the handle reach
your anus. You shouldn’t need to use any force during the
insertion.
If you experience resistance when inserting the catheter,
remove the catheter and make sure that your rectum is
empty. Digital evacuation may be needed to ensure that
the catheter can be safely and correctly inserted. This is
particularly important during the early use of the system.
When well established, your rectum will usually be empty
when conducting TAI. However, if resistance continues
do not force the catheter into your rectum. Stop using
the irrigation. Seek help from your healthcare professional.
Note: If you do not have sensation in your rectum and anal region,
your healthcare professional will probably ask you to digitally check
that your rectum is empty before you begin.
Note: Grip rings are avilable as a handling aid. See page 28 for more
information about the grip rings and other accessories available.
Note: Make sure that you are not sitting on the tubes or blocking
the water or air flow in the tubes in any way.
22
2. Inflate balloon. Inflate the balloon by pressing
on
the Navina Smart control unit. You can stop the inflation at
any time by releasing the button. Inflate the balloon up to
the size # , recommended by your healthcare professional.
Then gently pull the catheter slightly down to seal off
the rectum.
Note: If you need to adjust the position of the catheter, deflate
the balloon
completely and reposition the catheter.
Note: It is possible to deflate the balloon partially
, but if you
do not deflate the balloon completely, you will not be able to inflate
it back to your maximum setting. This is because the air used in
3
the first inflation will still count against your maximum total.
4
The “less than” sign beside the balloon size number on the display
< # – indicates that the balloon was not deflated completely.
3. Irrigate/instill water. Press
/
to instill the water
amount indicated by your healthcare professional into your
bowel. On the display you can check the amount of instilled
water under the water container symbol and the flow rate
over the catheter. You can stop or pause the instillation at
3
any time by releasing the button.
4
Note: Do not turn off the Navina Smart control unit during
irrigation! The Navina Smart control unit should not be turned
off until all tubes are disconnected! As long as the Navina Smart
control unit is on, it prevents backflow of water from the catheter
into the tubes.
23
Evacuation
4. Deflate ballon and remove catheter. Once you have
instilled the desired amount of water, press
until the
balloon is totally empty. The catheter may slide out by itself.
If not, pull out the catheter gently.
Note: You can let the catheter rest on the inside of the toilet
and keep it there until you flush or place the catheter back in
its package. Select which ever is more convenient for you.
Note: The catheter should be removed after deflation.
Do not remove the catheter from your rectum before
the balloon is completely deflated.
Note: If you experience resistance when removing the catheter try
to press the
again to make sure there is no air remaining in the
balloon. If there is still resistance, make sure that the tube between
the control unit and the catheter is not blocked. If there is still
resistance, disconnect the tube from the Navina Smart control unit.
5. Evacuation. If your colon does not start to empty on its
own, relax for 10-15 minutes and then try to lean forward,
cough, perform abdominal massage or move your upper
body to start the emptying process. The evacuation time is
individual and can vary from one day to another.
Disassembling and cleaning
1. Open the lid of the water container to minimize
the pressure in the system
24
5
2. Remove the light blue connection from the Navina Smart
control unit. If the catheter is still hanging in the toilet,
simply raise the tube to empty water from it into the toilet.
Let the tube rest at the side of the toilet. If the catheter is
already back in its package, empty the water through the
light blue connection into the toilet.
3. Remove the tube with the dark blue connection from
the Navina Smart control unit. Hold it high, so that the
remaining water flows back to the water container.
25
4. Turn off the Navina Smart control unit by pressing
the
button. Turn it upside down into the toilet
or sink to empty any remaining water from it.
Note: If the display has gone to power save mode, press the
to re-activate the display then press
once more and hold a few
seconds to turn off the Navina Smart control unit.
5
5. Remove the dark blue connection from the water container
and empty the remaining water from the container.
6. Holding the tube with the white connection, place the
catheter back in its packaging (if not already there) and
disconnect it from the tube. Dispose of the single use catheter
and the packaging with the normal household waste. Do not
flush the catheter down the toilet.
7. Clean and dry the remaining parts of the system. All components, except the single-use
catheter which should be disposed of after use, can be washed in mild soapy water.
Note: The Navina Smart control unit can be wiped with mild soapy water.
26
8. If you use the Navina Smart app and want to transfer the data, restart the Navina Smart
control unit and stay on the welcome screen on the display and start your Navina app
to start the synchronizing.
1. Turn on Navina Smart control unit and stay on welcome page.
2. Open 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 main menu in the app.
5. The Navina Smart control unit will turn itself off automatically once the data is transferred.
6. Rate the latest irrigation uploaded in the app.
Note: When you are on the welcome screen, Bluetooth® will be active to allow you to transfer your
data to your Navina Smart app if you wish. Bluetooth® is only active while you are on the welcome
screen. No data can be transferred while you are using the unit.
9. Recharge the Navina Smart control unit if necessary, or you may store it with all other
parts in the Navina case.
27
Accessories
Accessories are available to make using the Navina Smart system easier.
• To facilitate handling, the Navina Smart control unit can be attached to your thigh with
the help of the positioning strap and the Navina Smart control unit positioning clip.
• Two different grip rings are available to facilitate the handling of the rectal catheter.
• A lanyard is available if you would like to let the control unit hang around your
neck while you are not holding it.
• The accessories are included with the Navina Smart system. It is possible to order
the accessory set separately if you need a replacement.
Using the positioning strap
1. Thread the positioning strap with the Velcro facing down
through the positioning clip.
2. Adjust the length of the positioning strap by folding the
strap over itself and fixing it with the Velcro.
3. Place the positioning clip on the upper side of your thigh
and secure the positioning strap around your leg.
4. Place the Navina Smart control unit in the positioning clip
and slide it up until your hear/feel a “click”.
Note: the positioning clip and strap can remain on the control
unit when you are charging it.
Adjust the grip rings
1. Place one of the rings (vertical or horizontal) on the catheter tube, close to the rectal catheter connector. Press until
your hear/feel a “click” to secure the grip ring in place.
Note: If you have impaired sensation in your anal area and you
wish to use the grip ring, make sure your healthcare professional
shows you where the ring should be placed on the tube in order to
insert the catheter to the catheter handle and no further.
28
Using the lanyard
1. Thread the small loop through the bottom of the Navina
Smart control unit and pass the connection through the
thread loop.
2. Attach the connection on your lanyard.
3. The lanyard can then be used around your neck.
29
Frequently asked questions (FAQ)
As stated earlier, TAI is a very individual therapy method. For some individuals the method
will work after a couple of irrigations, for others it may take 4-12 weeks to create a working
bowel management routine.
What if I forgot the
code to unlock my
Contact Wellspect HealthCare, see contact information page 51.
settings?
When to charge?
The Navina Smart control unit is in a battery saving mode when
delivered. To activate the Navina Smart control unit you must place it
on the charger for a few seconds. Always charge your Navina Smart
control unit when the battery level is low. If you do not use it immediately after you have recieved it or use it infrequently, make sure to
charge the Navina Smart control unit by the latest date indicated on
the product package beside the
and at least once a year.
Preparation
How often should
I perform TAI?
At the start it is common to irrigate once every day for the first 10-14
days. Later on the frequency may possibly be reduced to once every
other day or every third day. Your frequency should be decided in
consultation with your healthcare professional.
Can I stop using stool
modifying medicine
when I start using
Navina?
TAI is usually part of a bowel management program. It is possible
that you may be able to reduce the amount of laxative you are using
eventually but you may have to continue using some to ensure your
stools have the right consistency to ensure easy evacuation. It is best
to continue with your current laxative regimen until you are getting
regular results from TAI. Consult your healthcare professional before
changing your regimen.
How long does
the procedure take?
It is very individual but the aim is that the bowel management
routine will take less than one hour. For some people the results are
fast and emptying of the bowel is complete. For others it will be more
time consuming and the bowel empties intermittently.
Can I add salt
to the water?
Navina Smart system can be used with a saline solution but the product needs to be rinsed thoroughly with clean water directly after use.
Is the water
temperature
important?
You should always use lukewarm water (36-38 °C/97-100 °F).
Water that is too cold can be unpleasant and you may experience
cramps. Water that is too hot may irritate the delicate lining of
your rectum and colon.
30
Can I use gel
No, the catheter is hydrophilic and will become slippery when
on the catheter?
immersed in water. There is no need to add gel.
No, the evidence shows that the risk of bowel perforation does not
Is the risk of bowel
perforation higher the increase the longer you use TAI.
longer I irrigate?
Activation
What water quality
should I use?
Only use clean tap water. If you do not have access to clean tap water,
use bottled water.
Instillation
should I instill?
Your healthcare professional will advise you how much water to use.
For adults it is common to start around 500 ml.
What water flow rate
Your healthcare professional will advise you. The water should be
should I use?
instilled at a rate fast enough to provide stimulation to the bowel
How much water
wall but not too fast as it can cause abdominal cramps, pain or strong
reflex contractions.
What balloon size is
Your healthcare professional will advise you of the appropriate
recommended?
balloon size. It should be just big enough to hold the catheter in place
and seal the anal opening to minimize leakage during irrigation.
What if I cannot get
Make sure that you have filled the water container with water, that
the lid is closed and that you have pressed
long enough so that
to the instillation
mode when I press
button?
the
water runs through the catheter and the catheter balloon deflation
symbol is shown at the bottom of the screen.
What if the balloon
does not inflate when
I press the button?
Make sure the Navina Smart control unit is on and that you are in
the instillation mode. This is the only mode where the balloon can
be inflated. Make sure the tubes are connected at the right place.
Make sure the tubes are connected tightly so the air does not leak.
Make sure the tubes are not blocked or kinked.
What if I cannot fill
the catheter balloon
more when I press
the balloon inflate
button?
You may have reached the maximum balloon size selected in your
settings. If there is a “<” sign beside the balloon size on your display,
it means you have deflated the balloon but not completely and then
tried to inflate it again. For safety purposes only a limited amount of
air can be filled in. Deflate the balloon completely and you will then
be able to inflate it again up to your maximum setting.
Why cannot I inflate
the balloon more
The maximum size of balloon inflation was selected after consultation
with healthcare professional experts, to meet the anatomical needs
than step 5?
and prevent over inflation of the balloon and the risk of balloon burst.
31
Can the balloon
Yes, there is a risk of the balloon bursting and this is why the Navina
burst and, if so,
is it dangerous?
Smart control unit has a maximum inflation size of the balloon already
set. It is also possible to change the maximum balloon inflation size
to a smaller size recommended by your healthcare professional.
This is done simply by entering the setting mode and changing
the maximum balloon inflation size setting. This minimizes both
the risk of over inflation and of balloon bursting.
Can I stop inflation?
Can I adjust the size
of the balloon?
You can stop the inflation of the balloon at any time by releasing
the button
.
You can deflate the balloon by pressing
.
Can I stop instillation You can stop the instillation of water at any time by releasing
the button
/
.
What if the Navina
If the control unit does not start when you press the on/off button,
Smart control unit
does not start?
it is probably because there is not enough power left to complete an
irrigation. Charge the control unit. The control unit cannot be used
while being charged.
What if the Navina
Smart control unit
does not charge?
If the control unit does not seem to be charging, make sure the inductive
charger is correctly placed in the charging support. Make sure the
charger is connected to the main socket. Make sure the Navina Smart
control unit is properly placed in the charging support.
How do I go to the
Press any button under the display when you are in the welcome
mode, to go to activation mode and press
to go to the instillation
next mode on my
Navina Smart control
unit?
mode when you are finished with the activation mode.
What if no water is
flowing when I press
the water buttons?
Make sure the Navina Smart control unit is on and that you are in
the activation or operation mode. Make sure there is water in the
container. Make sure the lid of the water container is closed. Make
sure the tubes are connected at the right places. Make sure the tubes
are connected tightly so the air does not leak. Make sure the tubes are
not blocked or kinked.
What if the water
flow is too low?
Please check the flow rate selected in your settings. Make sure the
lid of the water container is completely closed. Make sure the tubes
are connected at the right place. Make sure the tubes are connected
tightly so the air does not leak. Make sure the tubes are not blocked
or kinked. Make sure you are not impacted and that your rectum is
emptied. You may want to try placing the water container higher.
The pressure in the system might have reached the maximum and
the safety valve may be opened. Deflate the catheter and try to empty
the bowel. If you do not feel completely empty, make sure you are not
constipated and that your rectum is empty and repeat the irrigation
procedure.
32
What if the water
The display and the scale on the water bag have an accuracy of
instilled on the
display and the
+/- 50 ml so due to rounding effect the two scales could show
100 ml (0.1 l) difference. Note that the amount of water is shown in
scale on the water
container do not
l (litres) on the display.
indicate the same
amount of water
instilled?
What if debris from
Do not turn off the Navina Smart control unit until you have
the catheter flow
back in the tube?
disconnected the tubes from the control unit. If you do experience
debris from the catheter flowing back in the tube, you can clean the
tube by pumping water through it. New tubes can also be ordered
separately if needed.
What if bleeding
should occur?
A small amount of bleeding or smearing of blood on the catheter
may occur and should not alarm you. More severe or sustained rectal
bleeding with or without pain suggests a possible bowel perforation,
which should be treated as a medical emergency and requires
immediate medical attention.
What should I do
if I feel pain?
If cramps, discomfort or pain occur while instilling the water, pause
instillation for a few moments and continue more slowly once the
discomfort has subsided, ensure that the water is warm enough, at
body temperature. If pain is severe or persistent stop the irrigation
immediately. It could be perforation of the bowel which should be
treated as a medical emergency.
What if I feel
sweating,
palpitations or
dizziness during
irrigation?
If you have a spinal cord injury this may be a sign of autonomic
dysreflexia. Instill the water slowly and limit the time on the toilet
depending on tolerance. If symptoms are bothersome, ensure that you
are not alone when irrigating until symptoms at each TAI are reduced
or minimized. If you are at risk of autonomic dysreflexia, you should
have medication easily to hand in your home. If autonomic dysreflexia
occurs, stop the irrigation immediately. Further assessment and
possibly other treatments are required before continuing with TAI.
What if there is
leakage of water
around the catheter?
Ensure that the catheter is properly located. Check water temperature.
Increase balloon inflation up to your personal maximum setting.
Instill water more slowly.
What if the catheter
gets expelled before
I have deflated the
balloon?
Minimize inflation to avoid triggering reflexes. Instill the water more
slowly. Contact your healthcare professional who will assess and treat
any rectal impaction that may be causing the rectal expulsion.
33
Evacuation
What if my bowel
Try to lean forward, cough or perform abdominal massage. If water
does not empty?
and the bowel content still do not come out, you may be severely
constipated and a manual clean-out of the rectum might be necessary.
You might also be dehydrated, so remember to drink a lot of water and
repeat the TAI procedure the day after. If you have been successfully
using TAI for a while it might be that your colon is clear and this
could be a first indication that the TAI frequency could be reduced.
What if I feel resistance when trying to
remove the catheter/
the balloon does not
deflate completely?
If you feel any resistance when removing the catheter, try to press
again to make sure all air is removed from the balloon. If there is
still resistance, make sure that the tube is free. If that does not help,
disconnect the tube from the control unit, this should allow all the air
to leave the balloon.
Disassembling
Can I reuse
the catheters?
No, the rectal catheter is for single-use only. Dispose of it after use in
the normal household waste. If reused, Wellspect HealthCare cannot
guarantee the functionality nor the safety of the product. Reuse may
lead to infection.
How should I store
After the components are cleaned and dried, you may store your
my Navina system?
Navina system in the Navina case and keep it out of direct sunlight.
Also ensure that the tubes are not kinked and that the system is kept
away from sharp objects. Keep away from children.
Can I wipe the
No, only use mild soap and water as the alcohol may negatively affect
Navina Smart
control unit display
with alcohol?
the display and reduce visibility of the information on the display.
34
35
Troubleshooting
Navina Smart control unit
If an error message (Warning triangle with a three digit code) is shown in the display
of the Navina Smart control unit, follow the recommended actions as suggested below.
These warnings are divided in 3 types:
1. Warning codes 101-499
Once warning read and/or corrective actions are taken, the treatment can resume by pressing
the
button.
2. Warning code 501-999
Once warning read and/or corrective actions are taken, turn off the Navina Smart control unit
and restart the unit.
3. Warning 204 and 304
The unit reached the end of its life and must be changed. It can be restarted but it can no longer
be used.
Error: type 1
Reason
Action
Water flow too high
1. Check for blockage in the safety valve in the lid
of the water container
2. Place the water container lower
3. Press balloon deflation button to proceed
4. Still problem? Contact Wellspect HealthCare
No water flow
1. Check for free flow in all tubes
2. Check for enough water in the container
3. Ensure that the lid on the water container
is closed
4. Press balloon deflation button to proceed
5. Still problem? Contact Wellspect HealthCare
Balloon deflation
malfunction
1. Check for free flow in all tubes
2. Check that the air outlets on the back of the
Navina Smart control unit (the area between
the two white/grey buttons) are free
3. Press balloon deflation button to proceed
4. Still problem? Contact Wellspect HealthCare
101
102
103
36
End of life for Navina
Smart control unit
Replace your Navina Smart control unit
201 - Less than 50 irrigations remains
202 - Less tha 10 irrigations remains
203 - 0 irrigations remains
301 - Less than 2 month lifetime left
302 - Less than 2 weeks lifetime left
303 - 0 lifetime left
Press balloon deflation button to proceed
Bluetooth®
malfunction
Note: Navina Smart control unit can still be used
for irrigations but data cannot be transfered to
Navina Smart app
1. Press balloon deflation button to proceed
or restart the Navina Smart control unit
and try again
3. Still problem and If using Navina Smart app?
Contact Wellspect HealthCare
Reason
Action
Water pump
malfunction
1. Release the water buttons and try again
2. Restart Navina Smart control unit and try again
3. Still problems? Contact Wellspect Heathcare
Balloon malfunction
1. Check for free flow in all tubes
2. Check for blockage in the connections
3. Check for correct assembling of the tubes
and catheter
4. Replace the catheter and try again
5. Restart Navina Smart control unit and try again
6. Still problem? Contact Wellspect HealthCare
Balloon malfunction
1. Restart and try again
2. Still problem? Contact Wellspect HealthCare
Device malfunction
1. Restart and try again
2. Still problem? Contact Wellspect HealthCare
201-203
301-303
401-405
Error: type 2
501-599
601-649
650-699
701-999
37
Error: type 3
Reason
Action
No treatments left
Replace Navina Smart control unit
No time left
Replace Navina Smart control unit
204
304
38
Signs and symbols
Manufacturer (Shelf box includes date of manufacture indicated as
year, month and day)
REF
Reference number. Article number representing the product when ordering
LOT
Lot number
SN
Serial number (includes date of manufacture indicated as year, month and day)
Use by
Single use
Follow instructions for use
Consult instructions for use
Caution
WEEE – Waste electrical and electronical equipment, indicates separate collection
for electrical and electronic equipment
IP class 65. IP65 is the Ingress Protection enclosure definied as “dust tight
and protected against low pressure jets of water”
IP65
Type BF applied part
Non-ionized electromagnetic radiation
FCC: 17VAN17 Federal Communications Commission Identification, Bluetooth® ID
US federal law restricts this device to sale by or on the order of a physician
Charge by. This symbol on the packaging label indicates the date when
the Navina Smart control unit should be charged by at the latest.
+70 °C
Temperature limitation, indicates the range of temperature to which the medical
device can be safely exposed during transport and storage
+35 °C
Temperature limitation, indicates the range of temperature to which the medical
device can be safely exposed during operation
93 %
Humidity limitation, indicates the range of humidity to which the medical device
can be safely exposed during transport and storage
1060
hpa
Atmospheric pressure limitation, indicates the range of atmospheric pressure to
which the medical device can be safely exposed during transport and storage
-25 °C
+5 °C
0
500
39
Warranty
Warranty
This product is warranted by Wellspect HealthCare to the original purchaser to be free from
defects in material and workmanship. The Navina Smart control unit is valid for up to 400
irrigations within two years from the date the product is first used.
In the event of defect, contact your healthcare provider or your local Wellspect HealthCare
office (see contact information page 51). If you wish to make a claim under this warranty you
will need to return the products. Your healthcare provider or your local Wellspect HealthCare
office will advise you on how the return should be made and how the replacement product
will be delivered to you.
This warranty does not apply if the products were not used in accordance to the instruction
for use or have been subject to misuse, abuse or alteration.
40
Technical specification
– Navina Smart system
Power - charging
110-240 V, 50/60 Hz
Charger mat: ZENS model: ZESC03B/00
Power adapter: HAMA model 137224
Battery
3,7 V, 2600 mAh / Li-Ion
Size
200 x 30 x 70 mm
Weight
400 g
Operation temperature
+5 to +35 °C
Operation relative humidity
15-93% non-condensing
Operation atmospheric pressure
700-1060 hPa
Transport/storage temp.
-25 to +70 °C, up to 93 % rel. hum. non-condensing
Transport/storage atmospheric pressure
500-1060 hPa
Actual flow rate accuracy
+/- 50 ml/min
Balloon inflation
Minimum size 31,5 ± 5mm
Maximum size 65,0 ± 5mm
Maximum balloon size levels, upper range
When the setting BALLOON SIZE is set between 3-5 the balloon shall never exceed a diameter of 70 mm.
Maximum balloon size levels, lower range
When the setting BALLOON SIZE is set between 1-2 the balloon shall never exceed a diameter of 50 mm.
System shall ensure emptying of the balloon
When the system considers the balloon to be FULLY DEFLATED, the balloon diameter shall be less than
20 mm +/- 10%.
Water pump controllability, start
The water pump shall never start if there is no finger on any on the water pump buttons.
41
Water pump controllability, stop
The water pump shall always stop within 700 ms when finger is lifted from any of the water pump buttons.
Maximum water volume
1,5 liter
Maximum pressure in water path
Maximum pressure in water path: 160 mBa
The catheter is an applied part.
Portable and mobile radio frequency communications equipment can affect
the Navina Smart control unit.
Navina Smart control unit needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to
the EMC information provided.
WARNING: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Navina Smart control unit , including cables specified by the manufacturer, when using
Navina Smart. Otherwise, degradation of the performance of this equipment could result.
WARNING: Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
WARNING: After transportation/Storage, allow the Navina Smart control unit to reach
the operating temperature before use. This can take up to 60 minutes.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
If the warnings above is not honored, the following malfunctions can occur:
* The balloon might get too large.
* Air can be pumped into the colon.
* The balloon might not be able to fully deflate.
Navina Smart is in compliance with the essential requirements and other relevant provisions
of Directive 1999/5/EC.
42
Electro magnetic compatibility
Electromagnetic emission
Guidance and manufacturer’s declaration – electromagnetic emissions
The Navina Smart is intended for use in the electromagnetic environment specified below.
The customer or the user of the Navina Smart should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
Group 1
The Navina Smart uses RF energy only for its internal
CISPR 11
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
Class B
CISPR 11
The Navina Smart is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
Navina Smart is intended for use in the electromagnetic environment specified below.
The customer or the user of the Navina Smart should assure that it is used in such an
environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment
– guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
43
Electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
Navina Smart is intended for use in the electromagnetic environment specified below.
The customer or the user of the Navina Smart should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment
– guidance
Conducted
RF
3 Vrms
3 Vrms
150 kHz to
IEC
80 MHz
150 kHz to
80 MHz
Portable and mobile RF communications equipment
should be used no closer to any part of Navina Smart
3 V/m
3 V/m
Radiated
80 MHz to
80 MHz to
RF
IEC
61000-4-3
2,5 GHz
2,5 GHz
61000-4-6
than the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1,2 √P
d = 1,2 √P 80 MHz to 800 MHz
d = 2,3 √P 800 MHz to 2,5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be
less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
44
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Navina Smart control unit is used exceeds
the applicable RF compliance level above, the Navina Smart control unit should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Navina Smart control unit.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances
Wireless communications equipment such as wireless home network devices, mobile phones,
cordless telephones and their base stations and walkietalkies can affect this equipment and
should be kept at least at a distance according to the table below, away from the equipment.
Recommended separation distances between portable and mobile RF communications
equipment and the Navina Smart
The Navina Smart is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Navina Smart can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Navina Smart as recommended
below, according to the maximum output power of the communications equipment.
45
Rated maximum
output power of
transmitter W
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d = 1,2 √P
80 MHz to 800 MHz
d = 1,2 √P
800 MHz to 2,5 GHz
d = 2,3 √P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
46
Quick guide
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. Charging
1. Place the inductive charger unit
in the charging support.
2. Plug the power adapter into
the mains socket.
3. Plug the power adapter cable
into the charger.
4. Place the Navina Smart control
unit on the charging support.
2. Settings
1. Enter settings by pressing
.
2. Select maximum balloon size.
4
3. Select maximum water volume
to instill.
4
4
1.0
1.0
4
4. Select flow rate for button 1
.
5. Select flow rate for button 2
.
6. Select pin code if desired.
7. Exit setting by pressing
.
Select the parameter
/
with
(up/down).
47
Select the level
/
with
(+/-).
3. Preparation
1. Fill water container.
2. Connect the water container tube
between water container
and control unit (dark blue).
3. Connect the catheter tube
between control unit and
catheter (light blue/white).
4. Activation
1. Turn on the Navina Smart control
.
unit by pressing
2. Press any button to go to the
activation mode (
/
/
/
).
4
3. Press
/
to pump water
until the catheter tube is covered.
4. Press
when you are ready to
insert the catheter to proceed
to the Instillation mode.
5. Instillation
1. Insert the rectal catheter to
the handle.
2. Press
to inflate the catheter
balloon until the desired balloon
size is reached.
4
3. Gently pull catheter slightly down
to seal the rectum.
4. Instill water by pressing
/
.
48
6. Evacuation
Note: do not turn off the control unit
until the disassembly stage.
1. Press
to deflate the balloon.
2. Remove catheter.
4
4
3. Allow bowels to empty.
7. Disassembly
1. Open water container lid.
2. Disconnect tubes from control unit.
3. Empty water from tubes.
4. Turn off the Navina Smart control
unit and empty water from control
unit.
5. Disconnect catheter and dispose
in household waste.
6. Disconnect tube from water
container and empty water.
7. Rinse, clean and dry system.
8. Transfer data
1. Turn on Navina Smart control unit
and stay on welcome page.
2. Open 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 main menu
in the app.
5. The Navina Smart control unit will
turn itself off automatically once
the data is transferred.
6. Rate the new irrigations uploaded
in the app.
49
We value your opinion!
Your opinion could help make a difference to transanal irrigation
(TAI) users everywhere. Navina Systems were developed with
the help of an international group of healthcare professionals
and users practicing TAI. For future developments it is important
that we receive feedback from customers like you – which is why
we invite you to join our survey panel – TellUs. If you would like
to make a valuable contribution as a TellUs panel member,
please register at www.navinasystems.com.
50
Contact information
United Kingdom
Wellspect HealthCare
Brunel Way, Stonehouse,
Gloucestershire, GL10 3GB.
Tel: 0800 652 3350
Fax: 01453 791001
www.wellspect.co.uk
Australia
Australian Sponsor:
Dentsply Sirona Pty Ltd
11-21 Gilby Road
Mount Waverley VIC 3149
For more information please go to:
www.wellspect.com.au
Other markets
Wellspect HealthCare
Export Department,
P.O. Box 14, SE-431 21,
Mölndal, Sweden.
Tel: +46 31 376 40 00
E-mail: [email protected]
www.wellspect.com
51
Navina Systems
69009
Navina Smart system
1 Navina Smart control unit
with charger and cable
1 Tube set
2 Rectal catheters
1 Accessory set
1 Navina case
69005
Navina Classic system
1 Navina Classic control unit
1 Water container
x2
1 Tube set
2 Rectal catheters
1 Accessory set
1 Navina case
69006
Navina Classic system – refill
1 Navina Classic control unit
1 Water container
x2
69003
Consumable set
1 Tube set
2 Rectal catheters
1 Water container
15 Rectal catheters
x 15
68940
Rectal catheter set
10 Rectal catheters
x 10
69011
Tube set
1 Catheter tube
1 Water container tube
69012
Accessory set
2 Grip rings (1 vertical, 1 horizontal)
1 Lanyard
1 Positioning strap
1 Navina Smart positioning clip
69014
Navina Smart control unit with charger and cable
1 Navina Smart control unit
1 Charger
1 Power adapter
69013
Navina Classic control unit
Manufacturer
Wellspect HealthCare
Aminogatan 1, P.O. Box 14, SE-431 21 Mölndal, Sweden.
Phone: +46 31 376 40 00. www.navinasystems.com
1 Navina Classic control unit
2921-H
1 Water container
x2