TENA SmartCare Change Indicator User manual

www.tena.com
110786-5MA002-15
IFU TENA SmartCare
Change Indicator
Family caregivers
Version: 2020-01-28
TENA SmartCare
Change Indicator™
Family caregivers
Instructions for use

TENA SmartCare Change Indicator
2 3
TENA SmartCare Change Indicator
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
This guide is intended for family caregivers using the TENA SmartCare
Change Indicator™ in a home environment. The Change Indicator system
tracks and displays urine saturation levels in absorbent TENA
incontinence products.
TENA SmartCare Change Indicator is a system consisting of:
• AnappnamedTENASmartCare™Familythatcanbeinstalledonone
or more smartphones.
• AreusableChangeIndicatormadeupoftwoparts:asensorstrip
and a transmitter.
The TENA SmartCare Change Indicator is designed for people with
urinary incontinence who use TENA absorbent incontinence products
in a home environment. It provides support to family caregivers by
helping them decide when it is best to change absorbent incontinence
products without frequent manual checks. The TENA SmartCare Change
Indicator system tracks urine saturation but does not detect faecal episodes.
The TENA SmartCare Change Indicator is attached to the outside of
the incontinence product and tracks the urine saturation levels within.
Information about increasing levels of saturation is then delivered to
caregivers’ smartphones and viewed in the TENA SmartCare Family app.
This information helps caregivers decide whether the TENA incontinence
product needs to be changed or not.
In this guide, you will nd instructions for how to use:
The TENA SmartCare Change Indicator system including TENA
SmartCare Starter Kit, TENA SmartCare transmitter, TENA SmartCare
gateway, TENA SmartCare sensor strip and TENA SmartCare Family app.
The TENA SmartCare Change Indicator system is designed to be intuitive,
with family caregivers in mind. It does not require special training.
Information Contents
Information 2
Contents 3
Important information 4
Warning 5
TENA SmartCare Change Indicator components 6
Installation instructions
Download app and set up account 7
Explanation of app during use 8
Set up gateway 9
Register transmitter code 10
Install battery & assemble Change Indicator 11
Attach Change Indicator 12
Use Change Indicator 13
Remove Change Indicator 14
Intended use 15
Attachment instructions for supported TENA products
TENA Slip 16
TENA Flex 17
TENA Stretch Brief 18
TENA Pants/TENA Protective Underwear 19
TENA Brief 20
Change sensor strip & battery 21
Cleaning 22
Gateway lights & buttons 23
Transmitter lights & buttons 24
Water, sand and dirt 25
Troubleshooting 26–34
Technical descriptions
Operating characteristics 35–36
Electromagnetic compability (EMC) 37
Lifetime 37
Disposable parts 38
Labelling symbols 39
WARNINGCareshallbetakentoensuresafetyandeiciency.
Failure to do so could cause damage to equipment or lead to
the receipt of incorrect data.
NOTE Important information or advice/tips.
CHECK Important information for the device to function.
Symbols used in this guide

TENA SmartCare Change Indicator
4 5
TENA SmartCare Change Indicator
• KeeptheChangeIndicatorandChangeIndicatorbatteriesaway
from children and pets.
• OnlyaCR2032batteryshouldbeusedintheChangeIndicator.
Using the wrong type of battery, including rechargeable batteries,
can damage the Change Indicator.
• TheChangeIndicatorshouldbeattachedtotheoutsideofthe
incontinence product.
• TheChangeIndicatorisnotintendedtobeusedindirectcontact
with the skin.
• CleantheChangeIndicatorwhenfullyassembledtopreventwater
from entering the device. Do not submerge in water or clean in a
washing machine.
• DonotswingtheChangeIndicatorinthedirectionofpeople,pets
or nearby objects. Be aware of the risk of strangulation with the
sensor strip.
• Seekimmediatemedicalcareifthebatteryisswallowed.
• DonotattempttorepairormodifytheChangeIndicatororgateway
by yourself.
• IfanypartoftheChangeIndicatorsystemappearstobedamaged
or broken, it should not be used. Contact TENA for support.
• Donotexposethebatteryathightemperatures,disassembleit,
damageitmechanicallyorputbatteryintothereasthiscancause
anexplosionorare.
• Donotusegatewaysandhandhelddevicechargerswithunapproved
power supplies.
• Ensureyouhavereadandunderstoodthese‘Instructionsforuse’
before using the product. Save these instructions for future reference.
• Ifyouencounteranyproblems,equipmentfailureorifany
other incidents occur, report them to the manufacturer or TENA
SmartCare Support.
Important information Warning

TENA SmartCare Change Indicator
6 7
TENA SmartCare Change Indicator
000 000 000 000 000 000 000 000 000 000
000 000 000 000 000
000 000 000 000 000
1
3
INVITE OTHER CAREGIVERS
Invite others who care for your loved one.
This will give them access to the app.
2
Download app and set up account
DOWNLOAD TENA
SMARTCARE FAMILY APP
INVITE OTHER CAREGIVERS
Download the TENA SmartCare Family app
from App Store or Google Play and then register
your account.
Follow set-up instructions on the TENA
SmartCare Family app. The transmitter
code is located on the back of the
transmitter or on the packaging.
Invite others who care for your loved
one. This will give them access to the
TENA SmartCare Family app.
A SMARTPHONE
with TENA SmartCare Family
app, iOS 11 / Android 7
or later.
A SUPPORTED TENA
INCONTINENCE PRODUCT
(See supported TENA
products on pages 16–20 of
this guide or in the TENA
SmartCare Family app).
CONSUMABLES:
Sensor strip short, sensor strip medium, sensor strip long, battery.
ADHESIVE STRIPS OR
SCREWS, x2
You also need (not included):
GATEWAY
MOUNTING
BRACKET
POWER
ADAPTER
BATTERY, CR2032, x2
Length: S, M or L
Place to write
SENSOR STRIP, x2
Button
LED light
TRANSMITTER
Buttons
LED Light
TENA SmartCare Change Indicator components
TENA
SmartCare
Family app
REGISTER THE TRANSMITTER

TENA SmartCare Change Indicator
8 9
TENA SmartCare Change Indicator
REF
SN
IP65
FCC ID:
IC:
UDI:
MD
10
40
1
1
2
3
2
3
Steady light
= connected
Blinking light
= connecting
No light
= OK
Set up gateway
Placement
NOTE
The gateway should
be placed within 10 m
(33 ft) of the user
and connected to an
electrical power outlet.
Click!
See page 23
Gateway lights & buttons
You can also place the gateway
on a at surface
Screws or
adhesive tape
x2
Explanation of app during use
DRY
– no action needed
The absorbent core of the TENA product is dry
and the surface feels dry to the skin.
SOME URINE
– no action needed
There is some urine in the absorbent core of
the TENA product. However, the surface still
feels dry to the skin. If the absorbent product
has been on for an extended period and the
user has sensitive skin, you may want to
consider changing it.
WET
– consider change
There is a large amount of urine in the absorbent
core of the TENA product. The surface probably
still feels dry to the skin, but you should consider
a change – especially if the absorbent product
has been on for an extended period and/or the
user has sensitive skin.
10 m (33 ft)
Light

TENA SmartCare Change Indicator
10 11
TENA SmartCare Change Indicator
1 2 3
1 2 3
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
000 000 000 000 000
000 000 000 000 000
000 000 000 000 000
000 000 000 000 000
Assemble Change Indicator (transmitter + sensor strip)
Install battery
WARNING Only CR2032 batteries shall be used
in the TENA SmartCare Change Indicator.
Install battery & assemble Change IndicatorRegister transmitter code
1 Findthetransmittercode,which
is located on the back of the
transmitter or on the packaging.
2 Enterthetransmittercode
in the TENA SmartCare Family
app to register.
CR2032
Light blinks
5 times = OK
Steady light for a few
seconds = OK
See page 24
Transmitter
lights & buttons
See page 24
Transmitter
lights & buttons
Click!
Click!
TOP
TOP

TENA SmartCare Change Indicator
12 13
TENA SmartCare Change Indicator
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
12
3 4
2
1
3
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
Apply TENA product
on the resident
TENA Flex
TENA Flex
See supported products on pages 16–20 of this guide or in the TENA SmartCare Family app.
Blinking light:
Change battery, see page 21
Forexplanationsofappnotications,seepage8.
Apply the TENA product
with Change Indicator
on your loved one.
Steady light for a few seconds:
Continue to step 6
Press both buttons simultaneously for two seconds at every
change. This records the change of incontinence product in
the TENA SmartCare Family app and resets the system.
Attach Change Indicator Use Change Indicator
NOTE
Always attach the Change Indicator before you unfold the incontinence
product. Start by placing the Change Indicator at the front of the inconti-
nence product, on the thicker absorbent area, ensuring it is straight. (1)
PressrmlytoensuretheChangeIndicatorhasfullcontactwiththe
incontinence product.
Align transmitter with top of the thicker absorbent area of the
incontinence product.
Keep folded
Place tightlyAlign with top of thicker
absorbent area
Find the front
Please note that product size and sensor strip length do not always match.
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
DRY
– no action needed
SOME URINE
– no action needed
WET
– consider change
TENA
SmartCare
Family app
FRONT
THICKER
ABSORBENT
AREA
FRONT

TENA SmartCare Change Indicator
14 15
TENA SmartCare Change Indicator
10
40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
1
2
3
NOTE
The Change Indicator
should be removed while
the user is still wearing
the incontinence product.
Gently pull the change
indicator down from the
top, then roll the user onto
his/her side before
completing removal. (1)
Remove Change Indicator Intended use
Intended Use:
The TENA SmartCare Change Indicator is an accessory to absorbent
incontinenceproducts,intendedforuseonindividual(s)suering
from urinary incontinence in a home or professional environment who
are dependent on one or more caregivers to change the absorbent
incontinence products. The TENA SmartCare Change Indicator estimates
the degree of urine saturation in the absorbent incontinence product and
notiesthecaregiver(s).Thisfacilitatesthecaregiverdecisionregarding
when to change the absorbent incontinence product.
Standard operation:
• IftheChangeIndicatorisbroken,itshouldbereplaced,notrepaired.
• TheChangeIndicatorshouldnotbeincontactwiththeuser’sskin
during normal use. It should always be attached to the outside of the
incontinence product.
• TheChangeIndicatorisoperatedbythecaregiveroftheincontinent
user. The user wears the TENA Change Indicator in combination with
a TENA incontinence product.
• AttachingtheChangeIndicatortotheincontinenceproductis
considered a primary operating function.
• OnlythecaregiverisintendedtointeractwiththeChangeIndicator.
• ToturntheTransmitterOFF,removethebattery.
• TheChangeIndicatorisintendedforoneuseronlywithhealthyskin.
Advanced operation:
• ChangingthebatteryandSensorstripareoperationsthatshould
be carried out infrequently.
Using the TENA SmartCare Change Indicator according to its intended
use does not add any risk compared to not using it.
The medical device complies with emission and immunity standards
andregulations.Ithasbeentestedandfullsrequirementsforhome
healthcare environments.
Always make sure the
Change Indicator has been
removed before disposing of
the TENA incontinence
product.

TENA SmartCare Change Indicator
16 17
TENA SmartCare Change Indicator
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
1
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
Apply TENA product
on the resident
Apply TENA product
on the resident
23
456
TENA Flex
TENA Flex
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
1
4
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Flex
TENA Flex
TENA Flex
TENA Flex
BACK
BACK
FRONT
FRONT
BACK
BACK
FRONT
Please note that product size
and sensor strip length do not
always match.
TENA Slip
Plus, Super or Maxi
The TENA SmartCare Change Indicator should always be attached when the
incontinence product is folded and before it has been applied to the user.
TENA Slip TENA SmartCare
sensor strip length
S S
M M
L L
Keep folded Align with top of
thicker absorbent area
Find the front
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
Attachment instructions for supported TENA products
23
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
56
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
TENA Flex
Please note that product size
and sensor strip length do not
always match.
TENA Flex
Plus, Super or Maxi
The TENA SmartCare Change Indicator should always be attached when the
incontinence product is folded and before it has been applied to the user.
TENA Flex TENA SmartCare
sensor strip length
S S
M M
L M
Keep folded Align with top of
thicker absorbent area
Find the front
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
Place tightly Every time you change an
incontinence product, press both
buttons simultaneously for two
seconds to reset the transmitter.
Place tightly
Every time you change an
incontinence product, press both
buttons simultaneously for two
seconds to reset the transmitter.
Ensure the Change Indicator is straight.
Smooth any sensor strip wrinkles, then press
rmlytoensuretheChangeIndicatorhasfull
contact with the TENA absorbent product.
Ensure the Change Indicator is straight.
Smooth any sensor strip wrinkles, then press
rmlytoensuretheChangeIndicatorhasfull
contact with the TENA absorbent product.
FRONT
FRONT
THICKER
ABSORBENT
AREA
THICKER
ABSORBENT
AREA
FRONT

TENA SmartCare Change Indicator
18 19
TENA SmartCare Change Indicator
1 2 3
456
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
1 2 3
456
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
Apply TENA product
on the resident
Apply TENA product
on the resident
TENA Stretch
Brief
TENA SmartCare
sensor strip length
M/R M
L/XL L
Keep folded
Place tightly
Find the front
TENA Stretch Brief
Super or Ultra
The TENA SmartCare Change Indicator should always be attached when the
incontinence product is folded and before it has been applied to the user.
TENA Pants TENA SmartCare
sensor strip length
S S
M S
L S
Every time you change an
incontinence product, press both
buttons simultaneously for two
seconds to reset the transmitter.
Keep folded
Place tightly
Find the front
TENA Pants / TENA Protective Underwear
Plus or Super
The TENA SmartCare Change Indicator should always be attached when the
incontinence product is folded and before it has been applied to the user.
FRONT
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
Every time you change an
incontinence product, press both
buttons simultaneously for two
seconds to reset the transmitter.
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
THICKER
ABSORBENT
AREA
FRONT
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
Please note that product size
and sensor strip length do not
always match.
Align with top of
thicker absorbent area
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
Please note that product size
and sensor strip length do not
always match.
Align with top of
thicker absorbent area
Ensure the Change Indicator is straight.
Smooth any sensor strip wrinkles, then press
rmlytoensuretheChangeIndicatorhasfull
contact with the TENA absorbent product.
Ensure the Change Indicator is straight.
Smooth any sensor strip wrinkles, then press
rmlytoensuretheChangeIndicatorhasfull
contact with the TENA absorbent product.
FRONT
FRONT
THICKER
ABSORBENT
AREA

TENA SmartCare Change Indicator
20 21
TENA SmartCare Change Indicator
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
1 2 3
456
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
Apply TENA product
on the resident
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Brief TENA SmartCare
sensor strip length
R M
M M
L L
XL L
TENA Brief
Super or Ultra
The TENA SmartCare Change Indicator should always be attached when the
incontinence product is folded and before it has been applied to the user.
Attachment instructions for supported TENA products
NOTE
Ifyouhavediicultyremovingthebattery,tapthe
transmitter in your hand until the battery falls out.
Battery replacement
If the LED light starts to blink, either the battery needs to be replaced or the transmitter is not
properly attached to the sensor strip. The CR2032 battery will last for up to 4 weeks. However,
the battery can be changed whenever needed.
TENA sensor strip
The sensor strip is designed to withstand approximately 4 weeks continuous use.
Sometimes, however, the hooks on the back of the sensor strip can become covered with
bresorlint.Thispreventsthehooksfromattachingtotheincontinenceproduct.Ifthe
bresorlintcannotberemoved,thesensorstripshouldbechanged.Thesensorstrip
shouldalsobechangedifitbecomessoiledwithfaecesandcannotbecleanedsuiciently.
For cleaning advice, see page 22 of this guide.
Change sensor strip & battery
1 P r e s s
1 P r e s s
2 Remove
transmitter
2 Remove
battery
Ensure the Change Indicator is straight.
Smooth any sensor strip wrinkles, then press
rmlytoensuretheChangeIndicatorhasfull
contact with the TENA absorbent product.
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
Keep foldedFind the front
Place tightly Every time you change an
incontinence product, press both
buttons simultaneously for two
seconds to reset the transmitter.
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
TENA Slip/
TENA Stretch Brief/
TENA Brief
TENA Pants/
TENA Underwear
THICKER
ABSORBENT
AREA
FRONT
Please note that product size
and sensor strip length do not
always match.
Align with top of
thicker absorbent area

TENA SmartCare Change Indicator
22 23
TENA SmartCare Change Indicator
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
Change Indicator
Only clean the Change Indicator when it is
fully assembled. The transmitter and sensor
strip should never be cleaned separately.
Clean the Change Indicator using a cloth and
disinfectant when required. The device can
be rinsed under a tap.
AnybresorlintattachedtotheVelcro
shouldberemovedtoensureasecuret
between the Change Indicator and the
absorbent incontinence product. Fibres can
be removed using the end of the sensor strip
or gently with a lint roller (adhesive paper).
Gateway
Clean the gateway with a dry
cloth when needed.
Cleaning
WARNING
Clean the Change Indicator when fully assembled to prevent
water entering the device.
Do not clean in the washing machine.
Do not submerge in water.
Gateway lights & buttons
NOTE
TheLEDlightcanbediicult
to see if exposed to strong
sunlight, for example. To
improve visibility, try blocking
out any strong sunlight.
Gateway installation
Once the gateway has been connected to a power outlet.
COLOUR LED LIGHT WHAT IT MEANS
Blinking blue light:
Wait. The system is connecting.
Allow up to 60 seconds for light to start blinking.
Steady green light:
Everything is OK.
No light:
Green light disappears after a while and the system goes into
dark mode. Push the button to see if it has power and
connection. If no light comes on, check the power connection.
Steady red light:
Error. See TROUBLESHOOTING section, p. 26–34 of this guide
for more information.
LED light
Button

TENA SmartCare Change Indicator
24 25
TENA SmartCare Change Indicator
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
Transmitter lights & buttons
NOTE
TheLEDlightcanbediiculttosee
if exposed to strong sunlight, for
example. To improve visibility, try
blocking out any strong sunlight.
LED LIGHT WHAT IT MEANS
Blinksvetimes:
Battery is in correct position.
Attach transmitter to
sensor strip.
No light: OK
The light disappears after a few
seconds. Check for power by
pressing both buttons simulta-
neously for two seconds.
Change Indicator assembly
Once the transmitter has been attached to
the sensor strip.
Applying the Change Indicator to the incontinence product
Press both buttons simultaneously for two seconds at every change of incontinence product. This
records the change of incontinence product in the TENA SmartCare Family app and resets the system.
LED LIGHT WHAT IT MEANS
Steady light for a few seconds:
Everything is OK.
Blinkvetimes:
Transmitter is not attached
properly or battery is low.
Try re-attaching transmitter.
No light: OK
The light disappears after a few
seconds. Check for power by
pressing both buttons simulta-
neously for two seconds.
LED LIGHT WHAT IT MEANS
Steady light for a few seconds:
Everything is OK.
Blinksvetimes:
Transmitter is not attached
properly. Try re-attaching.
Or: battery is low. Change battery.
No light at all:
Error. See TROUBLESHOOTING
section, p. 26–34 of this guide for
more information.
Buttons on
each side
LED Light
Battery installation
Once the battery has been installed in the
transmitter.
The Change Indicator (when fully assembled with transmitter and sensor strip)
hasaclassicationofIP54.IP54indicatesthatitisprotectedagainstsmallobjects
and splashing water. Use of an approved disinfectant spray product or wipe is
recommended. Always clean Change Indicator when fully assembled – never attempt
to clean individual parts separately.
WARNING
If water has entered the sensor strip or transmitter,
ensure it is completely dry before use.
Water, sand and dirt

TENA SmartCare Change Indicator
26 27
TENA SmartCare Change Indicator
PROBLEM ITEM ACTION
Connection
error
Gateway 1. Press the gateway button. If there is a
steady green light everything is OK.
2. If there is a blinking blue light, the gateway
is trying to connect.
3.Ifthegatewaydoesn’tconnectafterve
minutes, try moving it to a position in the
room where the Internet connection
is stronger.
4. If this does not help, please contact TENA
SmartCare support.
5. If no light comes on after pressing the
gateway button, check that the power cable
and power adapter are both properly
connected.
6. If this does not help, please contact TENA
SmartCare support.
PROBLEM ITEM ACTION
Connection
error
Change
Indicator
1. Make sure the transmitter is properly
attached to the sensor strip. (see p. 11
of this guide)
2. Press both buttons simultaneously for
two seconds.
3. If there is no light, change the battery and
re-attach the transmitter to a sensor strip.
Press both buttons simultaneously. If there
is a steady light for a few seconds,
everything is OK.
4. If there is a blinking light, check that the
transmitter is properly attached to the
sensor strip. Adjust if needed, then press
both buttons simultaneously. If the light
continues blinking, change the battery.
If there is a steady light for a few seconds,
everything is OK.
5. If this does not help, attach to a new sensor
strip. Press both buttons simultaneously.
If there is a steady light for a few seconds,
everything is OK.
6. If this does not help (no light or blinking light
after correctly attaching to the sensor strip),
please contact TENA SmartCare Support.
Troubleshooting

TENA SmartCare Change Indicator
28 29
TENA SmartCare Change Indicator
PROBLEM ITEM ACTION
Connection
error
System
range
1. Both the user and transmitter should be
in range of the gateway – usually within
10 metres or 33 feet.
2. Try moving the gateway to a place where
it is within range of the transmitter.
Connection
error
Network
failure
Occasionally, the cellular network may go
down. If this happens, revert to a manual
changing routine until the system is up and
running again.
Change
Indicator
falls o
Change
Indicator
1. Firstly, make sure you are using one of the
supported TENA absorbent incontinence
products with a textile-like backsheet (see
p. 16–20 of this guide). The Change Indicator
does not attach to absorbent products with
a plastic backsheet.
2. Make sure you attach the Change Indicator
to a folded product, straight from its plastic
packaging. Do not attach it when the user is
already wearing the absorbent product.
3. Check the Velcro-covered side of the sensor
strip to see if it is covered with lint. Remove
any lint.
PROBLEM ITEM ACTION
I don’t
understand
the
notications
Status
indication
Thenoticationsaretheretosupportyour
decision making regarding when to change
the absorbent incontinence product without
having to check manually. There are three
dierentnotications:
1. Dry – two empty drops: The absorbent core
of the TENA product is dry and the surface
feels dry to the skin.
2.Someurine–Onelledandoneempty
drop: There is some urine in the absorbent
core of the TENA product. However, the
surface still feels dry to the skin. If the
absorbent product has been on for an
extended period and the user has sensitive
skin, you may want to consider changing it.
3.Wet–twolleddrops:Thereisalarge
amount of urine in the absorbent core of
the TENA product. The surface probably
still feels dry to the skin, but you should
consider a change – especially if the
absorbent product has been on for an
extended period and/or the user has
sensitive skin.

TENA SmartCare Change Indicator
30 31
TENA SmartCare Change Indicator
PROBLEM ITEM ACTION
The system
noties me
too early
Status
indication
You experience that the “consider change”
noticationshowswhenanabsorbentproduct
is still dry or has not been worn for long.
1. Make sure you are using one of the
supported TENA products (see p. 16–20 of
this guide).
2. Make sure you are using the correct
sensor strip length for your TENA product
(see p. 16–20 of this guide).
3. Make sure the Change Indicator is attached
correctly (see p. 12 of this guide).
4. If this does not help, please contact TENA
SmartCare Support.
PROBLEM ITEM ACTION
The system
noties me
too late
Status
indication
You experience that the “consider change”
noticationshowswhenanabsorbentproduct
is already too wet to be comfortable or the
product has been worn for a long time.
1. Make sure you are using one of the
supported TENA products (see p. 16–20 of
this guide).
2. Make sure you are using the right sensor
strip length for your TENA product
(see p. 16–20 of this guide).
3. Make sure the Change Indicator is attached
correctly (see p. 12 of this guide).
4. If this does not help, please contact TENA
SmartCare Support.
5. In cases of a clinical reaction, e.g. skin
irritation, please revert to a manual
changing routine and consult a healthcare
professional.
I don’t
receive any
notications
at all
Status
indication
1. Check the ”Connection error” section of
this troubleshooting guide.
2. Check that you have entered the correct
transmitter code. The transmitter code
you entered can be found under “account/
hardware” in the TENA SmartCare
Family app.
3. If this does not help, please contact TENA
SmartCare Support.

TENA SmartCare Change Indicator
32 33
TENA SmartCare Change Indicator
PROBLEM ITEM ACTION
How do
I clean the
Change
Indicator?
Change
Indicator
1. Always clean the Change Indicator when
fully assembled, i.e. with the transmitter
properly attached to the sensor strip. Never
clean the individual parts separately as
liquids or dirt may damage the electronics.
2. Clean on a regular basis, using a damp cloth
or paper.
3. For more thorough cleaning, use an
ethanol-based sanitizer for disinfection.
4. Use the free end of the sensor strip to
remove lint from the Velcro.
PROBLEM ITEM ACTION
How often
should the
Change
indicator
be cleaned?
Cleaning 1. As a rule-of-thumb, clean the Change
Indicator as frequently as you change the
bed linen.
2. Clean when needed, e.g. if soiled.
3. Remove lint from the Velcro-covered side
when required. This will ensure the Change
Indicator stays securely attached to the
incontinence product.

TENA SmartCare Change Indicator
34 35
TENA SmartCare Change Indicator
TYPE CAPACITY / VOLTAGE
CR2032 220 mAh/3.0 V nominal
Battery module
ChangeIndicatorisclassiedasaninternallypowereddeviceforcontinuousoperation.
CHARACTERISTICS VALUE/RANGE
Wireless technology RF communication, BLE
RF frequency 2.4 GHz
Max output level (ERP) 0 dBm
Electrical emissions Class B, level 47 dB mV/m
Operating voltage 2.7 – 3.3 V
Power consumption Avg. 135 uW
Peak 75 mW
Remote communication
range
At least 10 metres (33 feet) in open environment,
without obstructions
Processing unit
Transmitter & gateway
Operating characteristics
PROBLEM ITEM ACTION
The user’s
skin has
become
irritated and
turned red
Clinical
reactions
If the user’s skin becomes irritated, please
revert to a manual changing routine and
consult a healthcare professional.
The
incontinence
product was
lled with
faeces, but
the system
did not
notify me
Faeces The system does not detect faeces. In case of
frequent faecal episodes, please revert to a
manual changing routine.
This value is with recommended battery: CR2032

TENA SmartCare Change Indicator
36 37
TENA SmartCare Change Indicator
CONDITION MINIMUM MAXIMUM
Storage & transport temp. +10 °C +40 °C
Storage & transport humidity 65% Rh 85% Rh
Operating temp. +15 °C +45 °C
Operating humidity
(non-condensing) 15% Rh 90% Rh
Pressure 700 hPa 1060 hPa
Environmental conditions
Product component dimensions (mm/inch)
ITEM LENGTH WIDTH HEIGHT DIAMETER
Transmitter 51.8 mm / 2.04"34.5 mm / 13.58"13 mm / 0.51"N/A
Sensor strip
(S, M, L) 510–690 mm / 20.08–27. 16"27.5 mm / 1.08"7.6 mm / 0.30"N/A
Battery N/A N/A 3.2 mm / 0.13" 20 mm / 0.79"
Product weight (g/ounce)
COMPONENT WEIGHT
Transmitter 12.6 g / 0.44 oz
Sensor strip (S, M, L) 12.6 – 15.9 g / 0.44 – 0.56 oz
Battery 3.0 g / 0.11 oz
RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm
(12") to the Change Indicator. Otherwise, degradation of the
performance of this equipment could result.
Interference may occur in the vicinity of equipment marked with
this symbol.
Electro magnetic compability (EMC)Operating characteristics
• Readbestbeforedateonaccompanyingpackaging.
• Expectedlifetimeofthetransmitteristwoyearsandthesensorstripis4weeks,
aftertherstuse.
• Expectedshelflife(fromthemanufacturingdate)forthetransmitteris
three years and the sensor strip three years.
Lifetime

TENA SmartCare Change Indicator
38 39
TENA SmartCare Change Indicator
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
REF
SN
IPXX
FCC ID:
IC:
UDI:
MD
10 40
IP54
• CleantheChangeIndicatorbeforedisposal.
• FollowlocalregulationsfordisposaloftheChangeIndicator,thegatewayand
the batteries.
• Thisdeclarationrelatesexclusivelytotheradioequipmentinthestateinwhichit
was sold and excludes components that are added and/or operations carried out
subsequentlybythenaluser.
WEEE-marking:
• Thisproducthasbeendesignedwithrecycling,reuseandwastemanagementasa
consideration. Essity will provide the necessary information to recycling facilities
and government agencies as required by WEEE Directive. For more information,
please contact Essity at www.tena.com.
• TheproductwillbelabelledwiththeWEEEmarkingasshownontheside,
in accordance with European Standard EN 50419.
• TheproperdisposalofWEEEproductswillconservenaturalresources
(through re-use and recycling) and protect environmental and human
health through proper disposal.
• WEEE-labelledproductsmustbekeptseparateandreturnedtoa
designated collection point for dismantling, recycling and/or reuse.
• Theseparatecollectionandrecyclingofyourwasteequipmentatthetimeof
disposal will help to conserve natural resources and ensure that it is recycled in a
manner that protects human health and the environment. For more information
aboutwhereyoucandropoyourwasteequipmentforrecycling,pleasecontact
your local government, your commercial, institutional and/or municipal waste
disposal service or the location where you purchased the product.
Disposable parts Labeling symbols
The following symbols may appear on your TENA SmartCare Change Indicator,
accessories and/or packaging:
Manufacturer
Instruction manual
WEEE-marking.
Dispose of electrical
components in
accordance with your local
regulations
Radio Frequency
Radiation Symbol
Catalogue number
Serial number
IPClassication
FCC ID number
IC ID number
Unique Device
Information
European Conformity
mark
Do not wash
Medical Device
Single patient –
multiple use
Temperature limit
Manufacturing date
Not MR safe