background image

• 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  fire,  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  specified  
operating conditions as operation outside the de-
fined  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

Summary of Contents for SteadyTemp

Page 1: ...ATION 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 ...

Page 2: ... patch this could reduce overall adhesiveness After applying the patch smooth it out gently on all sides to fix 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 ...

Page 3: ...he 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 confirm successful activation 3 Read Patch After a successful data transfertheappdisplaysyour current body temperature ...

Page 4: ...f your currently measured temperature is outside the defined measurement range then it will not be displayed in the temperature chart In the field 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 duratio...

Page 5: ...p 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...

Page 6: ...ed 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 INTENDED USE Contraindications The SteadyTemp system should not be used under following circumstances Emergency situations Known allergy to ...

Page 7: ...ngle 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...

Page 8: ...re readings Use the patch only within the specified operating conditions as operation outside the de fined 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 imm...

Reviews: