SteadySense SteadyTemp User manual

• SteadyTemp is not intended for persons under 5
years of age
• SteadyTemp does not substitute the
consultation of a medical professional.
• The patch shall not be used by individuals who
are not capable of using the device correctly.
•Do not use the patch for any purpose other than
measuring axillary temperature.
•Measured temperature values are processed by
SteadyTemp for display purposes.
• Do not use the patch more than once, it is a single
use product.
• Do not apply the patch on injured skin.
• Do not use the patch if it has been
damaged or contaminated.
• Do not attempt to dissemble or open the patch. Do
not fold or twist the SteadyTemp patch.
• Do not apply successive patches on the same body
side.
• Do not use the patch when undergoing an MR or
CT examination.
• The SteadyTemp Patch is a mini electronics de-
vice. Do not dispose of the patch in the regular
household waste.
• Do not throw the patch in the re, the
battery could explode.
• Do not wear the patch for longer than 7 days.
• Store the patch out of the reach of children, pets
and people with impairments.
SteadyTemp is a clinical thermometer intended to
continuously measure axillary temperature and to
display relative changes in axillary temperature to
the user.
The SteadyTemp system can be used by medical
professionals in clinical environments and
consumers in a home care environment. It is
intended to be used on people older than 5 years
of age.
The system consists of a sensor patch and a
smartphone application, the body temperature data
measured by the sensor is transmitted via Near-
Field-Communication (NFC) and subsequently
displayed by the smartphone application.
SAFETY
INSTRUCTIONS
SAFETY
INSTRUCTIONS
• The SteadyTemp patch is not intended to be used
by individuals (including children) with reduced
physical, sensory or mental capabilities, or lack
of experience and/or knowledge, unless they have
been given supervision or instruction concerning
use of the device by a person responsible for their
safety.
• Children must be supervised to ensure that they
do not play with the device.
• The patch must be worn in the correct po-
sition under the arm to ensure reliable
temperature readings.
• Use the patch only within the specied
operating conditions as operation outside the de-
ned conditions can damage the patch and cause
discrepancies in the accuracy of the measurements.
• Do not take an extended bath or go
swimming while wearing the patch.
• The patch should be stored in a dry place and pro-
tected from direct sunlight.
• If the patch becomes uncomfortable, please
remove it immediately.
• When applied, the patch can cause local and
temporary skin irritations.
INSTRUCTIONS FOR USE
EXPLANATION OF SYMBOLS:
0°C
40°C
Lot number
Manufacturer
Expiration date
Medical Device
Single Use Product
Dispose of in battery bin
Storage temperature
Observe terms of use
www.steadytemp.info/ifu
Safety advice
Information
NFC required
SteadySense GmbH
Kärntnerstraße 518
A-8054 Seiersberg-Pirka
IFU Version: 21_12
Publication date: 22.12.2021
SUPPORT
For questions or problems with the
product please contact us via E-Mail:
[email protected]
INTENDED USE
Contraindications
The SteadyTemp system should
not be used under following
circumstances:
Emergency situations
Known allergy to ingredients of
skin patches

Wounds, skin diseases or
abrasions in the application
area of the SteadyTemp patch

DISPOSAL
The patch is powered by a button
cell battery. Therefore, it should not
be thrown out in the regular household waste
but disposed of according to the local waste
regulations for batteries and electricalgoods.
The SteadyTemp packaging is recyclable and
can be disposed of in the paper bin.
Position for NFC-Communication
App-notications about unusual body
temperature values can temporarily appear
due to extreme environmental inuences
If that is the case, please check if the patch is
still properly attached and read it again after
some time. Should the problem persist for
more than 6 hours, please contact our technical
support via E-Mail: [email protected]
NOTIFICATION:
“Temperature outside range“
If your currently measured temperature is
outside the dened measurement range, then
it will not be displayed in the temperature
chart. In the eld: “Last measurement”, either
“Lo” (for low temperature) or “Hi” (for high
temperature) will be displayed.
“Threshold alert“
After patch read-out, the app will inform you
when the measured temperature exceeds your
selected high temperature threshold for a
certain duration.
USER MANAGEMENT
In the user management you can view the data
of all users created in the app. If you want to
change a user name or delete the user, then
swipe the user name to the left to make the
changes.
NOTIFICATIONS
Android: Ensure NFC is activated
User assignment:
Follow app instructions
USING THE SENSOR PATCH:
1. Apply Patch
The patch should be
applied to clean dry
skin, free from cream or
deodorant. To apply the
patch relax your shoulder,
put your hand on your hip
and place 3 ngers directly under your arm.
Make sure that the round edges of the patch
point up and downwards.
2. Activate Patch
After 10 minutes you
can activate the patch.
Patch activation is a two
step process. Tap on the
patch icon in the app and
hold the backside of your
smartphone against the
patch in order connect the patch to a user.
After connection, hold the backside of your
smartphone against the patch to activate it – a
vibration will conrm successful activation.
3. Read Patch
After a successful data
transfertheappdisplaysyour
current body temperature
and stored temperature
curves. Please note that
measured temperature
values are processed by
SteadyTemp for display purposes. Reliable
temperature values are available about 1 hour
after the patch has been activated.
QUICK USE GUIDE
Download SteadyTemp app:
USAGE INFORMATIONS
• Before applying the patch, wash with non-
greasing soap and thoroughly dry the skin
under the arm. The patch application area can
also be cleaned using a suitable alcohol pad.
• Do not use deodorant or cream beforehand.
• When applying the patch, remove the small
part of the carrier foil rst.
• Do not touch the adhesive side of the patch,
this could reduce overall adhesiveness.
• After applying the patch, smooth it out gently
on all sides to x it in place.
• The patch should be read via NFC at least
once a day.
• Hold your smartphone as still as possible
while activating and reading the patch.
• Remove the patch immediately if it becomes
uncomfortable or causes skin irritation.
• Do not do physically intense sport or any
other activities that cause excessive perspiring
(sauna or steam room) while wearing the
patch.
•Throughout the day, small variations in body
temperature occur, which are shown by the
continuous measurement.
TECHNICAL DATA
Type of device: Clinical thermometer
Measuring site: Axilla
Type of use: Single use product
Typical application duration: 7 days
Measurement range: +30 to +42°C
Measurement accuracy: SteadyTemp
displays relative changes of the axillary
temperature with a maximum deviation of
+/-0.3°C.
Operating mode: Direct mode,
continuous
Measurement interval/time response:
300 seconds
Operating conditions: Environmental
temperature +15 to +42°C, RH: 15 to 95%,
air pressure: 86 to 106 kPA
Transport and storage conditions:
Environmental temperature: 0 to +40°C,
RH: 15 to 95%, air pressure: 86 to 106 kPa
System compatibility:
Apple: iOS 13 or higher on iPhone 7
or newer models
Android: Android OS 6.0
Marshmallow or newer on an NFC
enabled smartphone
Dimensions: 65 x 60 x 3 mm
Weight: 3 grams
Power source: 3V lithium button cell
battery (not replacable)
IP-Classication: IPX5: Protection
against waterjets from any direction

DISPOSAL
The patch is powered by a button
cell battery. Therefore, it should not
be thrown out in the regular household waste
but disposed of according to the local waste
regulations for batteries and electricalgoods.
The SteadyTemp packaging is recyclable and
can be disposed of in the paper bin.
Position for NFC-Communication
App-notications about unusual body
temperature values can temporarily appear
due to extreme environmental inuences
If that is the case, please check if the patch is
still properly attached and read it again after
some time. Should the problem persist for
more than 6 hours, please contact our technical
support via E-Mail: [email protected]
NOTIFICATION:
“Temperature outside range“
If your currently measured temperature is
outside the dened measurement range, then
it will not be displayed in the temperature
chart. In the eld: “Last measurement”, either
“Lo” (for low temperature) or “Hi” (for high
temperature) will be displayed.
“Threshold alert“
After patch read-out, the app will inform you
when the measured temperature exceeds your
selected high temperature threshold for a
certain duration.
USER MANAGEMENT
In the user management you can view the data
of all users created in the app. If you want to
change a user name or delete the user, then
swipe the user name to the left to make the
changes.
NOTIFICATIONS
Android: Ensure NFC is activated
User assignment:
Follow app instructions
USING THE SENSOR PATCH:
1. Apply Patch
The patch should be
applied to clean dry
skin, free from cream or
deodorant. To apply the
patch relax your shoulder,
put your hand on your hip
and place 3 ngers directly under your arm.
Make sure that the round edges of the patch
point up and downwards.
2. Activate Patch
After 10 minutes you
can activate the patch.
Patch activation is a two
step process. Tap on the
patch icon in the app and
hold the backside of your
smartphone against the
patch in order connect the patch to a user.
After connection, hold the backside of your
smartphone against the patch to activate it – a
vibration will conrm successful activation.
3. Read Patch
After a successful data
transfertheappdisplaysyour
current body temperature
and stored temperature
curves. Please note that
measured temperature
values are processed by
SteadyTemp for display purposes. Reliable
temperature values are available about 1 hour
after the patch has been activated.
QUICK USE GUIDE
Download SteadyTemp app:
USAGE INFORMATIONS
• Before applying the patch, wash with non-
greasing soap and thoroughly dry the skin
under the arm. The patch application area can
also be cleaned using a suitable alcohol pad.
• Do not use deodorant or cream beforehand.
• When applying the patch, remove the small
part of the carrier foil rst.
• Do not touch the adhesive side of the patch,
this could reduce overall adhesiveness.
• After applying the patch, smooth it out gently
on all sides to x it in place.
• The patch should be read via NFC at least
once a day.
• Hold your smartphone as still as possible
while activating and reading the patch.
• Remove the patch immediately if it becomes
uncomfortable or causes skin irritation.
• Do not do physically intense sport or any
other activities that cause excessive perspiring
(sauna or steam room) while wearing the
patch.
•Throughout the day, small variations in body
temperature occur, which are shown by the
continuous measurement.
TECHNICAL DATA
Type of device: Clinical thermometer
Measuring site: Axilla
Type of use: Single use product
Typical application duration: 7 days
Measurement range: +30 to +42°C
Measurement accuracy: SteadyTemp
displays relative changes of the axillary
temperature with a maximum deviation of
+/-0.3°C.
Operating mode: Direct mode,
continuous
Measurement interval/time response:
300 seconds
Operating conditions: Environmental
temperature +15 to +42°C, RH: 15 to 95%,
air pressure: 86 to 106 kPA
Transport and storage conditions:
Environmental temperature: 0 to +40°C,
RH: 15 to 95%, air pressure: 86 to 106 kPa
System compatibility:
Apple: iOS 13 or higher on iPhone 7
or newer models
Android: Android OS 6.0
Marshmallow or newer on an NFC
enabled smartphone
Dimensions: 65 x 60 x 3 mm
Weight: 3 grams
Power source: 3V lithium button cell
battery (not replacable)
IP-Classication: IPX5: Protection
against waterjets from any direction

DISPOSAL
The patch is powered by a button
cell battery. Therefore, it should not
be thrown out in the regular household waste
but disposed of according to the local waste
regulations for batteries and electricalgoods.
The SteadyTemp packaging is recyclable and
can be disposed of in the paper bin.
Position for NFC-Communication
App-notications about unusual body
temperature values can temporarily appear
due to extreme environmental inuences
If that is the case, please check if the patch is
still properly attached and read it again after
some time. Should the problem persist for
more than 6 hours, please contact our technical
support via E-Mail: [email protected]
NOTIFICATION:
“Temperature outside range“
If your currently measured temperature is
outside the dened measurement range, then
it will not be displayed in the temperature
chart. In the eld: “Last measurement”, either
“Lo” (for low temperature) or “Hi” (for high
temperature) will be displayed.
“Threshold alert“
After patch read-out, the app will inform you
when the measured temperature exceeds your
selected high temperature threshold for a
certain duration.
USER MANAGEMENT
In the user management you can view the data
of all users created in the app. If you want to
change a user name or delete the user, then
swipe the user name to the left to make the
changes.
NOTIFICATIONS
Android: Ensure NFC is activated
User assignment:
Follow app instructions
USING THE SENSOR PATCH:
1. Apply Patch
The patch should be
applied to clean dry
skin, free from cream or
deodorant. To apply the
patch relax your shoulder,
put your hand on your hip
and place 3 ngers directly under your arm.
Make sure that the round edges of the patch
point up and downwards.
2. Activate Patch
After 10 minutes you
can activate the patch.
Patch activation is a two
step process. Tap on the
patch icon in the app and
hold the backside of your
smartphone against the
patch in order connect the patch to a user.
After connection, hold the backside of your
smartphone against the patch to activate it – a
vibration will conrm successful activation.
3. Read Patch
After a successful data
transfertheappdisplaysyour
current body temperature
and stored temperature
curves. Please note that
measured temperature
values are processed by
SteadyTemp for display purposes. Reliable
temperature values are available about 1 hour
after the patch has been activated.
QUICK USE GUIDE
Download SteadyTemp app:
USAGE INFORMATIONS
• Before applying the patch, wash with non-
greasing soap and thoroughly dry the skin
under the arm. The patch application area can
also be cleaned using a suitable alcohol pad.
• Do not use deodorant or cream beforehand.
• When applying the patch, remove the small
part of the carrier foil rst.
• Do not touch the adhesive side of the patch,
this could reduce overall adhesiveness.
• After applying the patch, smooth it out gently
on all sides to x it in place.
• The patch should be read via NFC at least
once a day.
• Hold your smartphone as still as possible
while activating and reading the patch.
• Remove the patch immediately if it becomes
uncomfortable or causes skin irritation.
• Do not do physically intense sport or any
other activities that cause excessive perspiring
(sauna or steam room) while wearing the
patch.
•Throughout the day, small variations in body
temperature occur, which are shown by the
continuous measurement.
TECHNICAL DATA
Type of device: Clinical thermometer
Measuring site: Axilla
Type of use: Single use product
Typical application duration: 7 days
Measurement range: +30 to +42°C
Measurement accuracy: SteadyTemp
displays relative changes of the axillary
temperature with a maximum deviation of
+/-0.3°C.
Operating mode: Direct mode,
continuous
Measurement interval/time response:
300 seconds
Operating conditions: Environmental
temperature +15 to +42°C, RH: 15 to 95%,
air pressure: 86 to 106 kPA
Transport and storage conditions:
Environmental temperature: 0 to +40°C,
RH: 15 to 95%, air pressure: 86 to 106 kPa
System compatibility:
Apple: iOS 13 or higher on iPhone 7
or newer models
Android: Android OS 6.0
Marshmallow or newer on an NFC
enabled smartphone
Dimensions: 65 x 60 x 3 mm
Weight: 3 grams
Power source: 3V lithium button cell
battery (not replacable)
IP-Classication: IPX5: Protection
against waterjets from any direction

DISPOSAL
The patch is powered by a button
cell battery. Therefore, it should not
be thrown out in the regular household waste
but disposed of according to the local waste
regulations for batteries and electricalgoods.
The SteadyTemp packaging is recyclable and
can be disposed of in the paper bin.
Position for NFC-Communication
App-notications about unusual body
temperature values can temporarily appear
due to extreme environmental inuences
If that is the case, please check if the patch is
still properly attached and read it again after
some time. Should the problem persist for
more than 6 hours, please contact our technical
support via E-Mail: [email protected]
NOTIFICATION:
“Temperature outside range“
If your currently measured temperature is
outside the dened measurement range, then
it will not be displayed in the temperature
chart. In the eld: “Last measurement”, either
“Lo” (for low temperature) or “Hi” (for high
temperature) will be displayed.
“Threshold alert“
After patch read-out, the app will inform you
when the measured temperature exceeds your
selected high temperature threshold for a
certain duration.
USER MANAGEMENT
In the user management you can view the data
of all users created in the app. If you want to
change a user name or delete the user, then
swipe the user name to the left to make the
changes.
NOTIFICATIONS
Android: Ensure NFC is activated
User assignment:
Follow app instructions
USING THE SENSOR PATCH:
1. Apply Patch
The patch should be
applied to clean dry
skin, free from cream or
deodorant. To apply the
patch relax your shoulder,
put your hand on your hip
and place 3 ngers directly under your arm.
Make sure that the round edges of the patch
point up and downwards.
2. Activate Patch
After 10 minutes you
can activate the patch.
Patch activation is a two
step process. Tap on the
patch icon in the app and
hold the backside of your
smartphone against the
patch in order connect the patch to a user.
After connection, hold the backside of your
smartphone against the patch to activate it – a
vibration will conrm successful activation.
3. Read Patch
After a successful data
transfertheappdisplaysyour
current body temperature
and stored temperature
curves. Please note that
measured temperature
values are processed by
SteadyTemp for display purposes. Reliable
temperature values are available about 1 hour
after the patch has been activated.
QUICK USE GUIDE
Download SteadyTemp app:
USAGE INFORMATIONS
• Before applying the patch, wash with non-
greasing soap and thoroughly dry the skin
under the arm. The patch application area can
also be cleaned using a suitable alcohol pad.
• Do not use deodorant or cream beforehand.
• When applying the patch, remove the small
part of the carrier foil rst.
• Do not touch the adhesive side of the patch,
this could reduce overall adhesiveness.
• After applying the patch, smooth it out gently
on all sides to x it in place.
• The patch should be read via NFC at least
once a day.
• Hold your smartphone as still as possible
while activating and reading the patch.
• Remove the patch immediately if it becomes
uncomfortable or causes skin irritation.
• Do not do physically intense sport or any
other activities that cause excessive perspiring
(sauna or steam room) while wearing the
patch.
•Throughout the day, small variations in body
temperature occur, which are shown by the
continuous measurement.
TECHNICAL DATA
Type of device: Clinical thermometer
Measuring site: Axilla
Type of use: Single use product
Typical application duration: 7 days
Measurement range: +30 to +42°C
Measurement accuracy: SteadyTemp
displays relative changes of the axillary
temperature with a maximum deviation of
+/-0.3°C.
Operating mode: Direct mode,
continuous
Measurement interval/time response:
300 seconds
Operating conditions: Environmental
temperature +15 to +42°C, RH: 15 to 95%,
air pressure: 86 to 106 kPA
Transport and storage conditions:
Environmental temperature: 0 to +40°C,
RH: 15 to 95%, air pressure: 86 to 106 kPa
System compatibility:
Apple: iOS 13 or higher on iPhone 7
or newer models
Android: Android OS 6.0
Marshmallow or newer on an NFC
enabled smartphone
Dimensions: 65 x 60 x 3 mm
Weight: 3 grams
Power source: 3V lithium button cell
battery (not replacable)
IP-Classication: IPX5: Protection
against waterjets from any direction

• SteadyTemp is not intended for persons under 5
years of age
• SteadyTemp does not substitute the
consultation of a medical professional.
• The patch shall not be used by individuals who
are not capable of using the device correctly.
•Do not use the patch for any purpose other than
measuring axillary temperature.
•Measured temperature values are processed by
SteadyTemp for display purposes.
• Do not use the patch more than once, it is a single
use product.
• Do not apply the patch on injured skin.
• Do not use the patch if it has been
damaged or contaminated.
• Do not attempt to dissemble or open the patch. Do
not fold or twist the SteadyTemp patch.
• Do not apply successive patches on the same body
side.
• Do not use the patch when undergoing an MR or
CT examination.
• The SteadyTemp Patch is a mini electronics de-
vice. Do not dispose of the patch in the regular
household waste.
• Do not throw the patch in the re, the
battery could explode.
• Do not wear the patch for longer than 7 days.
• Store the patch out of the reach of children, pets
and people with impairments.
SteadyTemp is a clinical thermometer intended to
continuously measure axillary temperature and to
display relative changes in axillary temperature to
the user.
The SteadyTemp system can be used by medical
professionals in clinical environments and
consumers in a home care environment. It is
intended to be used on people older than 5 years
of age.
The system consists of a sensor patch and a
smartphone application, the body temperature data
measured by the sensor is transmitted via Near-
Field-Communication (NFC) and subsequently
displayed by the smartphone application.
SAFETY
INSTRUCTIONS
SAFETY
INSTRUCTIONS
• The SteadyTemp patch is not intended to be used
by individuals (including children) with reduced
physical, sensory or mental capabilities, or lack
of experience and/or knowledge, unless they have
been given supervision or instruction concerning
use of the device by a person responsible for their
safety.
• Children must be supervised to ensure that they
do not play with the device.
• The patch must be worn in the correct po-
sition under the arm to ensure reliable
temperature readings.
• Use the patch only within the specied
operating conditions as operation outside the de-
ned conditions can damage the patch and cause
discrepancies in the accuracy of the measurements.
• Do not take an extended bath or go
swimming while wearing the patch.
• The patch should be stored in a dry place and pro-
tected from direct sunlight.
• If the patch becomes uncomfortable, please
remove it immediately.
• When applied, the patch can cause local and
temporary skin irritations.
INSTRUCTIONS FOR USE
EXPLANATION OF SYMBOLS:
0°C
40°C
Lot number
Manufacturer
Expiration date
Medical Device
Single Use Product
Dispose of in battery bin
Storage temperature
Observe terms of use
www.steadytemp.info/ifu
Safety advice
Information
NFC required
SteadySense GmbH
Kärntnerstraße 518
A-8054 Seiersberg-Pirka
IFU Version: 21_12
Publication date: 22.12.2021
SUPPORT
For questions or problems with the
product please contact us via E-Mail:
[email protected]
INTENDED USE
Contraindications
The SteadyTemp system should
not be used under following
circumstances:
Emergency situations
Known allergy to ingredients of
skin patches

Wounds, skin diseases or
abrasions in the application
area of the SteadyTemp patch

• SteadyTemp is not intended for persons under 5
years of age
• SteadyTemp does not substitute the
consultation of a medical professional.
• The patch shall not be used by individuals who
are not capable of using the device correctly.
•Do not use the patch for any purpose other than
measuring axillary temperature.
•Measured temperature values are processed by
SteadyTemp for display purposes.
• Do not use the patch more than once, it is a single
use product.
• Do not apply the patch on injured skin.
• Do not use the patch if it has been
damaged or contaminated.
• Do not attempt to dissemble or open the patch. Do
not fold or twist the SteadyTemp patch.
• Do not apply successive patches on the same body
side.
• Do not use the patch when undergoing an MR or
CT examination.
• The SteadyTemp Patch is a mini electronics de-
vice. Do not dispose of the patch in the regular
household waste.
• Do not throw the patch in the re, the
battery could explode.
• Do not wear the patch for longer than 7 days.
• Store the patch out of the reach of children, pets
and people with impairments.
SteadyTemp is a clinical thermometer intended to
continuously measure axillary temperature and to
display relative changes in axillary temperature to
the user.
The SteadyTemp system can be used by medical
professionals in clinical environments and
consumers in a home care environment. It is
intended to be used on people older than 5 years
of age.
The system consists of a sensor patch and a
smartphone application, the body temperature data
measured by the sensor is transmitted via Near-
Field-Communication (NFC) and subsequently
displayed by the smartphone application.
SAFETY
INSTRUCTIONS
SAFETY
INSTRUCTIONS
• The SteadyTemp patch is not intended to be used
by individuals (including children) with reduced
physical, sensory or mental capabilities, or lack
of experience and/or knowledge, unless they have
been given supervision or instruction concerning
use of the device by a person responsible for their
safety.
• Children must be supervised to ensure that they
do not play with the device.
• The patch must be worn in the correct po-
sition under the arm to ensure reliable
temperature readings.
• Use the patch only within the specied
operating conditions as operation outside the de-
ned conditions can damage the patch and cause
discrepancies in the accuracy of the measurements.
• Do not take an extended bath or go
swimming while wearing the patch.
• The patch should be stored in a dry place and pro-
tected from direct sunlight.
• If the patch becomes uncomfortable, please
remove it immediately.
• When applied, the patch can cause local and
temporary skin irritations.
INSTRUCTIONS FOR USE
EXPLANATION OF SYMBOLS:
0°C
40°C
Lot number
Manufacturer
Expiration date
Medical Device
Single Use Product
Dispose of in battery bin
Storage temperature
Observe terms of use
www.steadytemp.info/ifu
Safety advice
Information
NFC required
SteadySense GmbH
Kärntnerstraße 518
A-8054 Seiersberg-Pirka
IFU Version: 21_12
Publication date: 22.12.2021
SUPPORT
For questions or problems with the
product please contact us via E-Mail:
[email protected]
INTENDED USE
Contraindications
The SteadyTemp system should
not be used under following
circumstances:
Emergency situations
Known allergy to ingredients of
skin patches

Wounds, skin diseases or
abrasions in the application
area of the SteadyTemp patch

• SteadyTemp is not intended for persons under 5
years of age
• SteadyTemp does not substitute the
consultation of a medical professional.
• The patch shall not be used by individuals who
are not capable of using the device correctly.
•Do not use the patch for any purpose other than
measuring axillary temperature.
•Measured temperature values are processed by
SteadyTemp for display purposes.
• Do not use the patch more than once, it is a single
use product.
• Do not apply the patch on injured skin.
• Do not use the patch if it has been
damaged or contaminated.
• Do not attempt to dissemble or open the patch. Do
not fold or twist the SteadyTemp patch.
• Do not apply successive patches on the same body
side.
• Do not use the patch when undergoing an MR or
CT examination.
• The SteadyTemp Patch is a mini electronics de-
vice. Do not dispose of the patch in the regular
household waste.
• Do not throw the patch in the re, the
battery could explode.
• Do not wear the patch for longer than 7 days.
• Store the patch out of the reach of children, pets
and people with impairments.
SteadyTemp is a clinical thermometer intended to
continuously measure axillary temperature and to
display relative changes in axillary temperature to
the user.
The SteadyTemp system can be used by medical
professionals in clinical environments and
consumers in a home care environment. It is
intended to be used on people older than 5 years
of age.
The system consists of a sensor patch and a
smartphone application, the body temperature data
measured by the sensor is transmitted via Near-
Field-Communication (NFC) and subsequently
displayed by the smartphone application.
SAFETY
INSTRUCTIONS
SAFETY
INSTRUCTIONS
• The SteadyTemp patch is not intended to be used
by individuals (including children) with reduced
physical, sensory or mental capabilities, or lack
of experience and/or knowledge, unless they have
been given supervision or instruction concerning
use of the device by a person responsible for their
safety.
• Children must be supervised to ensure that they
do not play with the device.
• The patch must be worn in the correct po-
sition under the arm to ensure reliable
temperature readings.
• Use the patch only within the specied
operating conditions as operation outside the de-
ned conditions can damage the patch and cause
discrepancies in the accuracy of the measurements.
• Do not take an extended bath or go
swimming while wearing the patch.
• The patch should be stored in a dry place and pro-
tected from direct sunlight.
• If the patch becomes uncomfortable, please
remove it immediately.
• When applied, the patch can cause local and
temporary skin irritations.
INSTRUCTIONS FOR USE
EXPLANATION OF SYMBOLS:
0°C
40°C
Lot number
Manufacturer
Expiration date
Medical Device
Single Use Product
Dispose of in battery bin
Storage temperature
Observe terms of use
www.steadytemp.info/ifu
Safety advice
Information
NFC required
SteadySense GmbH
Kärntnerstraße 518
A-8054 Seiersberg-Pirka
IFU Version: 21_12
Publication date: 22.12.2021
SUPPORT
For questions or problems with the
product please contact us via E-Mail:
[email protected]
INTENDED USE
Contraindications
The SteadyTemp system should
not be used under following
circumstances:
Emergency situations
Known allergy to ingredients of
skin patches

Wounds, skin diseases or
abrasions in the application
area of the SteadyTemp patch