FAQ About SteadyTemp
What is SteadyTemp?
SteadyTemp is a CE-certified, wearable medical sensor patch that continuously measures body temperature for up to 10 days. It is worn discreetly under the armpit and transmits temperature data contactlessly via NFC to the SteadyTemp App for iOS and Android. The SteadyTemp App processes the temperature data and displays it graphically. SteadyTemp is developed and manufactured by SteadySense GmbH in Austria.
How does the SteadyTemp patch work?
The SteadyTemp Patch contains a precision temperature sensor that is placed under the armpit. It automatically measures and stores body temperature at adjustable time intervals. Using the SteadyTemp App on an NFC-enabled smartphone, the temperature data stored on the patch can be read out via NFC at any time.
Can SteadyTemp be used in hospitals and clinics?
Yes. SteadyTemp Professional is designed for clinical use and can be integrated into hospital information systems (HIS) via HL7/FHIR. For example, it is compatible with Roche cobas® pulse, the März Health Suite, and NursIT CareIT solutions. It supports postoperative monitoring, oncology, and all areas with increased monitoring needs.
Can SteadyTemp be used in clinical studies?
Yes. SteadyTemp is used in clinical studies where body temperature is of interest. SteadyTemp can be used offline, but also offers tele-monitoring capabilities via a dashboard as well as data export. The SteadyTemp Research Kit provides everything needed to start a study.
Is SteadyTemp CE-certified?
Yes. SteadyTemp is a CE-certified medical device of Class Im according to the EU Medical Device Directive (MDD), tested by a Notified Body. In addition, SteadyTemp is FDA510k approved. SteadySense GmbH has a quality management system certified according to ISO 13485:2016.
How long does the SteadyTemp patch last?
Each SteadyTemp Patch measures continuously for up to 10 days. It automatically stores temperature data and can be read out at any time with the SteadyTemp App on an NFC-enabled device.
Where can I buy SteadyTemp?
SteadyTemp patches are available at steadytemp.health/shop/, BIPA, Praxisdienst, monitoring-shop.de, Apotheken Bote, DocCheck Shop, Vamida, and the Austrian Red Cross.
Is SteadyTemp suitable for children?
Yes. SteadyTemp is skin-friendly, radiation-free, and barely noticeable. It is suitable for children over 5 years and adults. Parents can monitor fever at night without waking the child.
FAQ About SteadyTemp Home
How accurately does the SteadyTemp patch measure?
The SteadyTemp system achieves a laboratory accuracy of ±0.3 °C according to EN ISO 80601-2-56. The accuracy is verified at the system level through external laboratory tests – across the entire measurement chain, from the sensor patch to data processing in the app.
What temperatures are displayed?
The SteadyTemp App displays the temperature curve, the current temperature value, the temperature trend, the maximum temperature, and the average temperature. The measurement range is between +30 °C and +42 °C.
Are my health data processed securely?
Yes. Data captured by SteadyTemp and entered into the SteadyTemp App is stored exclusively locally on the device.
When should I connect the app to the patch?
You can connect the app to the patch at any time – simply hold an NFC-enabled smartphone briefly to the patch. The temperature curve will then be displayed immediately in the app. You do not need to remove the patch for this.
Can I share my temperature curve with my doctor's office?
Yes. SteadyTemp Home offers an export function that allows you to export and share the temperature curve, including entered entries, as a PDF.
Which smartphone models are compatible?
SteadyTemp Home works on any NFC-enabled smartphone – from iPhone 7 with iOS 13.0 or higher, and on Android devices from OS 6.0 Marshmallow with NFC functionality.
FAQ About SteadyTemp Professional
How does SteadyTemp Professional integrate into existing hospital IT?
SteadyTemp Professional transmits temperature data in accordance with the HL7/FHIR standard as FHIR Observations directly to configured endpoints within the clinic network. This enables standardized integration into electronic patient records and hospital information systems.
For which clinical areas is SteadyTemp suitable?
SteadyTemp supports continuous temperature monitoring in non-critical care areas, e.g., in postoperative monitoring, oncology, and infectiology – wherever continuous temperature profiles are relevant for clinical assessment.
Does the system support clinical decision-making?
SteadyTemp supports physicians and nursing staff through continuous temperature measurement and longitudinal visualization of temperature trends. Persistent temperature rises and conspicuous temperature changes become visible—providing a basis for an informed clinical assessment.
Which safety standards does the SteadyTemp system meet?
The SteadyTemp system meets applicable standards such as IEC 60601-1, IEC 60601-2, and ISO/IEC 14443-3. Development was carried out in accordance with EN 62304, EN 62366-1, and EN 82304-1. The SteadyTemp Patch has been tested for biocompatibility in accordance with ISO 10993-1.
Is patient data stored on the device?
No. SteadyTemp Professional does not store any data locally on the device. All information is transmitted exclusively and encrypted to the configured endpoint within the closed clinic network.
How is patient identification carried out?
In SteadyTemp Professional, patients are identified directly in the app. The recorded temperature data is assigned to the respective person and transmitted encrypted to the configured data system.
FAQ About SteadyTemp Care Sector
What advantages does SteadyTemp offer over traditional spot measurements?
Traditional spot measurements provide only snapshots. SteadyTemp captures body temperature continuously and makes temperature changes and trends visible that occur between two measurement points – a clinically relevant added value for early detection and timely action in response to temperature changes.
How does SteadyTemp relieve the burden on nursing staff?
Continuous temperature recording allows temperature changes to be documented seamlessly over longer periods – without manual spot measurements. Nursing staff thus have current temperature profiles available at all times and can deploy resources more efficiently.
Is SteadyTemp suitable for residents with limited mobility?
Yes. The SteadyTemp Patch is worn discreetly and non-invasively under the armpit – it is skin-friendly, radiation-free, and barely noticeable. Measurement occurs independently of activity or sleep, making it particularly suitable for individuals who cannot regularly participate in the measurement process.
Can a care service monitor several people simultaneously?
SteadyTemp allows the creation of multiple user profiles within one app. In the professional environment, patient data is transmitted directly to the configured data system. The specific scalability depends on the respective IT infrastructure.
Is the use of SteadyTemp subject to safety standards?
Yes. SteadyTemp is a CE-certified medical device. Both the SteadyTemp App and the SteadyTemp Patch comply with the relevant safety standards, including EN ISO 14971, EN 62304, EN 62366-1, EN 82304-1, and IEC 60601-1.
FAQ About SteadyTemp Studies
What data formats does SteadyTemp provide for study evaluations?
SteadyTemp exports temperature curves, including entries, as a PDF. SteadyTemp Professional transmits temperature data in HL7/FHIR format as FHIR Observations to configured endpoints – standardized and encrypted.
Can SteadyTemp be used to detect postoperative temperature changes?
SteadyTemp supports the detection of temperature changes outside regular spot measurements. A clinical study on early detection of postoperative infections is available at: https://link.springer.com/article/10.1007/s10877-025-01383-y
How is data security ensured in study environments?
In combined use with the SteadyTemp Dashboard, SteadyTemp ensures secure, GDPR-compliant processing and encrypted transmission of all data. SteadyTemp Professional does not store any data locally and transmits all information exclusively to configured, closed network endpoints.
What measurement accuracy is relevant for study protocols?
The SteadyTemp system has a verified laboratory accuracy of ±0.3 °C according to EN ISO 80601-2-56. The measurement interval can be individually adjusted.
Is SteadyTemp approved as a medical device for clinical studies?
SteadyTemp is a CE-certified medical device. It can be used in studies where body temperature is captured as a primary or secondary endpoint.
FAQ About SteadyTemp System
How are the patch and app technically connected?
The SteadyTemp Patch captures and stores temperature data in raw form. The SteadyTemp App reads this data via NFC and processes it using validated algorithms into temperature values in °C and displays them as a temperature curve.
How is the system's measurement accuracy proven?
The system accuracy of ±0.3 °C has been verified by external laboratory tests according to EN ISO 80601-2-56. The tests cover the entire measurement chain – from temperature acquisition by the patch to processing and display in the app.
Why is the armpit region used as the measurement site?
Axillary measurement (armpit) is the reference body site according to EN ISO 80601-2-56. It enables non-invasive, continuous temperature recording via the SteadyTemp Patch without affecting comfort or sleep.
What measurement range does the SteadyTemp system cover?
The output range of the SteadyTemp system is +30 °C to +42 °C.
How often does the SteadySense Patch measure temperature?
The measurement interval of the SteadyTemp Patch is 5 minutes by default, but can be individually adjusted if needed. The patch measures continuously after activation and stores the data automatically. With a 5-minute measurement interval, the patch should be read out approximately once every 3 days.
Does the patch emit radiation?
No. The SteadyTemp system uses NFC communication and does not emit active radiation. It complies with IEC 60601-1, IEC 60601-2, and ISO/IEC 14443-3.