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 wirelessly transmits temperature data via NFC to the SteadyTemp app for iOS and Android. 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 horizontally under the armpit. It automatically measures and stores body temperature at adjustable time intervals. When you hold an NFC-enabled smartphone to the patch, the data is immediately transferred to the SteadyTemp app, which displays temperature curves, fever charts, and statistics.
Can SteadyTemp be used in hospitals and clinics?
Yes. SteadyTemp Professional is designed for clinical use and integrates with hospital information systems (HIS) via HL7/FHIR. 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 a primary or secondary endpoint. It offers tele-monitoring, offline measurement, a central dashboard, and full data export. The SteadyTemp Research Kit (€449.00) provides everything needed to start a study.
Is SteadyTemp CE-certified?
Yes. SteadyTemp is a CE-certified medical device of class IIa according to the EU Medical Device Directive (MDD), audited by a Notified Body. SteadySense GmbH has a quality management system certified according to ISO 13485:2016.
How long does the SteadyTemp patch last?
Each SteadyTemp patch continuously measures for up to 10 days. It automatically stores temperature data and can be read out at any time with an NFC-enabled smartphone.
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 infants, children, 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 current axillary temperature, the temperature curve, the trend, the maximum temperature, and the average value. The displayed measurement range is between +30 °C and +42 °C, but can show more if needed.
Are my health data processed securely?
Yes. SteadyTemp ensures the secure processing and encrypted transmission of personal data and temperature data in accordance with the GDPR (EU 2016/679). Optional entries such as symptoms or well-being are 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?
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 the HL7/FHIR standard as FHIR Observations directly to configured endpoints within the hospital 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 doctors and nursing staff through continuous temperature measurement and the longitudinal visualization of temperature profiles. Persistent increases and noticeable temperature changes become visible – serving as a basis for informed clinical assessment.
Which safety standards does the SteadyTemp system meet?
The SteadyTemp system complies with IEC 60601-1, IEC 60601-2, and ISO/IEC 14443-3. Software and usability follow EN 62304, EN 62366-1, and EN 82304-1. The biological safety of the SteadySense Patch is certified according to 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 securely to the configured endpoint in the closed clinical network.
How is patient identification carried out?
In SteadyTemp Professional, patients are identified directly in the app. The collected temperature data is assigned to the respective patient and transmitted encrypted to the configured data system.
FAQ About SteadyTemp Care Sector
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 SteadySense 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 Home 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.
What advantages does SteadyTemp offer over traditional spot measurements?
Traditional spot measurements only provide snapshots. SteadyTemp continuously records body temperature and makes temperature changes and trends visible that occur between two measurements – a clinically relevant added value for early assessment.
Is the use of SteadyTemp subject to safety standards?
Yes. SteadyTemp is a CE-certified medical device. Both SteadyTemp (software) and the SteadySense Patch comply with the relevant safety standards, including 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 Home 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.
Is SteadyTemp approved as a medical device for clinical studies?
SteadyTemp is a CE-certified medical device according to EN ISO 80601-2-56 (clinical thermometer, continuous operating mode, axillary measurement). It can be used in studies where body temperature is recorded as a primary or secondary endpoint.
What measurement accuracy is relevant for study protocols?
The SteadyTemp system achieves a laboratory accuracy of ±0.3 °C (±0.54 °F) according to EN ISO 80601-2-56 §201.101.2. The measurement interval can be individually adjusted. Both values have been verified by external laboratory tests across the entire measurement chain.
Can SteadyTemp be used to detect postoperative temperature changes?
SteadyTemp supports the detection of temperature changes outside of regular spot measurements. A clinical study on the early detection of postoperative infections through continuous temperature monitoring is available as a manuscript and supports this application area.
How is data security ensured in study environments?
SteadyTemp ensures the 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.
FAQ About SteadyTemp System
How are the patch and app technically connected?
The SteadySense Patch records and stores raw temperature data. SteadyTemp (the app) reads this data via NFC and converts it into temperature values in °C using validated algorithms. The measurement chain is certified at the system level according to EN ISO 80601-2-56.
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 §201.101.2. 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 SteadySense 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 (+86 °F to +107.6 °F) – the clinically relevant range for axillary body temperature measurement.
How often does the SteadySense Patch measure temperature?
The measurement interval of the SteadySense Patch can be individually adjusted. The patch measures continuously and stores the data automatically – regardless of whether the app is currently connected.
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.