Frequently asked questions
Safety
Yes! Sleepiz device is safe to use. It has undergone thorough clinical studies, 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 and follow a compliant Quality Management System.
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, 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 0.008 in/0.2 mm, which even allows you to measure your pulse.
No, it does not. Radar is very common in 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 is about 16’700 times less radiation than what is known to produce adverse health effects.
Expand 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.
Yes, the Sleepiz One+ is a medical device (class II, 510(k) exempt) listed with the US Food and Drug Administration (FDA) and certified in European Union (CE class IIa), according to the European Medical Device Regulation (EU MDR).
Yes, the accuracy of the Sleepiz system has been validated through clinical studies. If you are interested in the validation results, please reach out to us.
No, the Sleepiz device does not interfere with any other devices. It has been tested for electromagnetic compatibility (EMC) and electrical safety tests and standards.
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 available in USA, Switzerland, and the European Union.
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.
Using Sleepiz
In the morning after you have completed a recording you can check the status of your recording in the “Status History” section on the home screen of the tablet. Please note that the processing of the data can take a few hours. The information on the data quality will be updated once the processing is complete. This usually happens after 11AM, the day after the recording.
A recording can be in one of the following statuses:
1) Dark Green: Recording was successful.
The data for the Sleepiz One+ are of good quality (more than 2 hours of signal with good quality).
2) Red: The recording was not successful as the data quality of the Sleepiz One+ was not sufficient.
We require a total amount of minimum 2 hours of good signal of the Sleepiz One+ device. If this Is not achieved, the status will be red.
There can be various reasons for a red status:
- The Sleepiz One+ was not placed correctly.
Please make sure you have set up the system correctly with the help of the setup guide. Common mistakes are that the Sleepiz One+ is placed at a wrong height or distance or that the arrow on top of the Sleepiz One+ was not pointing to the lower part of your chest.
- You were moving too far away from the device during the night.
If you have a large bed, you might have moved away from the Sleepiz One+ during the night. You can try to restrict your movement by building a small barrier with a blanket or pillows.
3) Blue: The recording is under processing
The recording was done and is currently under processing. No action is required from your side. The information on the data quality will be updated once the processing is complete. This usually happens after 11AM the day after the recording.
4) Yellow: Synchronization pending
A recording was done, but the synchronization to the cloud Is not complete. This can happen if the Tablet was not able to connect to the cloud properly. Please leave the devices ON throughout the day and make sure the Cloud symbol is green. The data will be processed once synchronization is completed.
5) Grey: No recording was done on that day.
No data was found for that day.
Generally, the Sleepiz device is intended for adults (Age >= 18 years). It is designed as a remote monitoring device for people who suffer from chronic 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 regular blankets or clothing.
Exception: Heavy or thick 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). If your pet sits on your chest or back during the night, this could interfere with the device recordings.
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 2 – 4 inches/5 – 10 centimeters above the mattress and the Sleepiz device should be placed 15 – 20 inches /40 – 50 centimeters 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. 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.
The power consumption of the device is 3.5W, and 5W for the tablet. These are all upper bound values. If the battery is drained out, the power consumption will reach the upper limit. As it charges for 5-6hrs the value will reduce until the battery charges completely. When the device is fully charged, the power consumption is 0 as the device runs off the battery (even while plugged in). When the battery discharges at a slight value, it draws some power which would be approximately 30% of the max power, until the battery is fully charged. If the device is connected all the time, this cycle will repeat. The power consumption while charging is comparable with the consumption of a mobile phone.
Magnetic therapy mats can potentially interfere with the Sleepiz device, as they might generate strong magnetic fields that in some cases can exceed the international recommended limit values. Thus, use of magnetic therapy mats simultaneously with Sleepiz device is not recommended.
Data protection
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, ISO 27701, and HIPAA 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 respiration rate or heart rate. We take an utmost care to take these data separate, so that the connection between your personal data and your health-related data is not maintained.
Your doctor or caregiver has access to your personal data and your health-related data. Our operations team, such has access to your personal data. They need the data for example to send you the device. Whereas our Care Team, who performs data analyses has access to your health-related data. They will however 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.
Trouble Shooting
If you encounter any problems with your Sleepiz device or any of its accessories, please follow the steps described In the Troubleshooting section on the DataHub.
Most of the problems can be solved by 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 has established internet connection. Please note that in this case you might not receive confirmation of your recording as might not have yet 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)
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.
Device setup and operation
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Sleepiz AG
Hornbachstrasse 23
8008 Zurich
Switzerland
www.sleepiz.com
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We are available Monday to Friday from 9:00 AM to 5:00 PM (CST).
Sleepiz AG is a certified medical device manufacturer according to ISO 13485