Yes! Sleepiz device is safe to use. It is a medically certified (CE IIa class) device that has undergone clinical tests as well as electromagnetic compatibility (EMC) and electrical safety tests. As Sleepiz AG, we are also certified as a Medical Device Manufacturer according to ISO 13485.
No, it does not. Radar is very common in our today’s world to measure distance, angle, or velocity of objects by sending out electromagnetic waves, like in most of our cars today. Or you might have heard of it in the context of medical ultra-sound measurements, which are based on the doppler effect. We are using the same principle, but on a very low frequency, as we measure really tiny body movements. To do this we use radiation which it is 16’700 times less radiation than what is known to produce adverse health effects.
Read more about our safety standards:
To evaluate the risks and safety of using millimeter (mm) wave technology on human tissue, we use the international guidelines. Firstly, millimeter wave frequencies are categorized as a non-ionizing radiation, meaning that the energy of smallest units of these waves is too low to cause electrons to move from their orbits. Being non-ionizing is quite important as ionization is the mechanism that is related to increasing the chances of cancer. The highest photon energy of a mm-wave photon is 1.2 meV while the photon energy needed to remove an electron from its atom is around 12 eV, meaning that mm-wave photon energy is 10’000 times less than what is needed to be ionizing [1]. Therefore, in general, non-ionizing radiation is much less harmful.
With our system we emit waves at a power level of 12 dB which is roughly equivalent to 15 mW at a frequency of 24GHz. According to the WHO radiofrequency (RF) fields above 10 GHz are absorbed at the skin surface, with very little of the energy penetrating into the underlying tissues. The basic dosimetric quantity for RF fields above 10 GHz is the intensity of the field measured as power density in Watts per square meter (W/m2). Exposure to RF fields above 10 GHz at power densities over 1000 W/m2 are known to produce adverse health effects, such as eye cataracts and skin burn. Our system emits a field density of 0.06 W/m2 (60 mW/m2). That means we emit 16’700 times less power than what is known to cause adverse health effects according to the WHO in the case of non-ionizing radiation in our frequency range [2].
In response to public concern, the World Health Organization established the International EMF Project in 1996 to assess the scientific evidence of possible health effects of electromagnetic fields (EMF) in the frequency range from 0 to 300 GHz. They have stated that although extensive research has been conducted into possible health effects of exposure to many parts of the frequency spectrum, all reviews conducted so far have indicated that, as long as exposures are below the limits recommended in the ICNIRP EMF guidelines, which cover the full frequency range from 0–300 GHz, such exposures do not produce any known adverse health effect [3],[4],[5]. The ICNIRP guidelines protect against all established RF health effects and are developed following reviews of all the peer-reviewed scientific literature, including reports on cancer and non-thermal effects. We operate within ICNIRP guidelines.
Imagine yourself breathing: you see that your chest goes up and down. This causes distance changes that are measured by our Sleepiz device. In addition to the latest hardware and software technology we apply signal processing as well as clinical and data science to generate actionable insights into your health to for example analyze your breathing pattern, or respiration rate.
That’s possible because using radar allows us to measure a large variety of tiny distances, as tiny as 0.2 mm, which even allows to measure your pulse.
Yes, the Sleepiz device is registered in Europe as a CE class IIa medical device according to the European medical device directive (MDD).
The Sleepiz system is continuously validated internally and externally. If you are interested in the validation, please reach out to us. Soon, some of these validations will also be available publicly.
No, the Sleepiz device does not interfere with any other devices. It has been tested for electromagnetic compatibility (EMC) and electrical safety tests and norms. However, please note that it should not be used if the person has an active electronic implanted device or together with life-supporting machines.
Currently, the Sleepiz device is currently available in Switzerland, the European Union and India.
In Sleepiz we focus on data privacy and security, therefore we use neither a camera nor a microphone. We operate solely based on radar technology to measure your sleep and to protect your privacy.
Generally, the Sleepiz device is intended for adults (Age >= 18 years). It is designed as a screening device for people that may have sleep apnea or respiratory diseases. Please take note that neither pregnant women, nor people with implanted electronic devices (active implants, such as pacemakers) should use the Sleepiz device.
Yes, you can sleep with a blanket while using a Sleepiz device. Our signals are not disturbed by blankets. Enjoy all the comfort of your home! 😉
Exception: Weighted blankets can disturb the measurement with the Sleepiz device. Please use a different blanket while using your Sleepiz device to make sure you get accurate recordings.
Yes, just make sure you are the one closer to the device. The device can then be perfectly used with two people in the same bed!
Yes, as long as they are not between the Sleepiz device and you (the person being monitored).
Unfortunately, no. This has not been tested and certified yet.
Use the stand provided to place the device next to your bed. The bottom of the Sleepiz device should be 5 to 10 centimetres above the mattress and the Sleepiz device should be placed 40 to 50 centimetres away from the body at the level of the lower part of the chest and the upper part of the stomach. Make sure that the arrow on the top of the device is pointing towards you.
You can also find these measurements in the instructions for use (IFU) that came with your device.
The Sleepiz device may be surface cleaned using a soft cloth dampened with a commercial, nonabrasive cleaner with, i.e. 70% alcohol (e.g. Indicin Plus Aktiv). Please do not spray, pour, or spill liquid onto the power supply, device, cables, or the sensor. Disconnect the power supply unit from the power before cleaning.
The Sleepiz device packaging can be surface cleaned using a soft cloth.
You can store your Sleepiz device in the packaging that it came in. If you are using it daily, you can also simply store it at your convenience, just ensure it does not get damaged.
Sleepiz takes data protection and information privacy very seriously. We do not just say that, but we really mean it. This is why we are ISO 27001 and ISO 27701 certified, making sure that every customer’s data and information is protected to the highest standards. Further, we make sure to use your data only, as per your consent. We do that to ensure that any health conditions cannot be traced to a patient's personal identity, to prevent that it is misused for other purposes.
We distinguish between personal data and health-related data. Personal data is information that relates to you as an individual, such as your name or address. Health-related data is the measurements we take, such as the heart rate. Your doctor has access to your personal data and your health-related data if you have ordered through your doctor. Otherwise, only our operations team, such as our telehealth coaches, have access to your personal and health-related data. They need the data for example to send you the report and discuss the results with you. Other staff, such as our data analysis team, will see your measurements with a pseudonymized ID, but will not have access to the personal data.
Our servers are located in the European Union, in Germany and Ireland.
If you encounter any problems with your Sleepiz device or any of its accessories, please follow the steps described In the Quick Setup Guide that comes within the package. Most of the problems can be solved with turning all devices OFF and then ON again.
In case you cannot get good internet connection on your tablet, which is indicated with the Cloud symbol remaining RED, you can continue with the measurement. The recording will be stored on the tablet and sent to our servers for analysis once the tablet established internet connection. Please note that in this case you might not receive confirmation of your recording as might not yet have reached our servers. If you have any questions, please contact our support team.
If you cannot solve the problem, please get in touch with Sleepiz Customer Support (email support@sleepiz.com or call +41 44 586 08 88).
You can check whether the Sleepiz device is on by looking at the system state indicator on the left-hand side of the device. The small light is green when the device is switched on and recording. Please also check the tablet: The Symbol of the Sleepiz device Is green If the device Is on and connected to the tablet.
