As parents, our lives are centered on our children’s health and safety. Some parents have expressed concern about the general safety of the product like a wearable baby monitor.
As a company of many parents who use the Smart Sock, we have completed rigorous testing to ensure the Smart Sock is safe for all families. In the spirit of trust and transparency, Jutika Gokarn, Owlet’s Senior Director of Quality Engineering and Risk Management, addresses some of your questions and concerns so you can confidently use our products.
- Is the Owlet Smart Sock safe?
The Owlet Smart Sock has not only been rigorously tested in-house but has been tested to all applicable mandatory and voluntary standards including but not limited to EN 71 Safety of Toys Standard, IEC/EN 62368 Safety Requirements, CE testing and registration, Biocompatibility Evaluations, REACH and RoHS chemical requirements.
- I love that the Sock fits my baby so well, but should I be worried about the small sensor?
The Smart Sock 3 was developed after reviewing all the feedback we received from our customers about the Smart Sock 2 s. The smaller profile of the new Smart Sock sensor will help reduce pressure-related red marks and allow easier transition between fabric sock changes. Safety was top of mind as we developed this product from both a hardware but also a software perspective.
The EN 71 Safety of Toys Standard is a collection of regulations that are potentially applicable to toy products. While our product is not intended for use by a child (therefore not required to meet the Safety of Toys Standard), we opt in to this testing because it requires us to adhere to a much higher safety standard. It also makes us prove through third-party testing that our products don’t have potential hazards like sharp edges or points, components that are sizes and shapes that could be potential choking hazards, flammability hazards, or embedded chemicals that are potentially harmful. We meet the small parts requirement in the EN Safety of Toys standard that was developed to ensure products like ours do not create any choking hazards. In addition, if the sock were to come off your baby’s foot for any reason, Owlet will notify you via the Base Station and the Owlet app so you are able to go put the Sock back on your baby’s foot.
- Is the Smart Sock a Medical Device?
Owlet products are not medical devices. They are only intended to assist you in tracking Baby’s well-being and do not replace you as a caregiver. Since the Smart Sock is not a medical device, it does not adhere to the Medical Device Directive (MDD). The Smart Sock is designed to provide parents with Baby’s information for peace of mind and complies with the following CE Directives:
- Council Directive 2014/53/EU (16 April 2014) – Radio Equipment
- Council Directive 2014/35/EU (26 Feb 2014) – Low Voltage
- Council Directive 2011/65/EU (08 Jun 2011) – Restrictions of Hazardous Substances
- Council Directive 2014/30/EU (26 Feb 2014) – Electromagnetic Compatibility
- Council Directive 2001/95/EC (03 Dec 2001)– General Product Safety
- Council Directive 2012/19/EU (04 Jul 2012) – Waste Electrical and Electronic Equipment
- Will the Smart Sock cause red marks on my baby?
The new Owlet Smart Sock was thoughtfully redesigned to address known to causes of red marks, like sizing, pressure, washing and friction. We believe the smaller sensor profile, our new Sock sizing and fabric materials should provide for an improved overall experience while using the Sock. The Sock has been tested to ensure our materials are safe to use with your baby’s soft skin, and that is free of sensitizers and allergens.
- Should I be worried about electromagnetic fields (EMF) from the sock?
We have tested our products to meet regulatory standards that define limits on radio frequency (RF) energy for products like ours, and the Smart Sock RF energy is less than 1/4 of the RF levels that the FCC uses to regulate products in the market today.
Specific absorption rate (SAR) levels is the measure of the amount of RF energy (including EMF) that is absorbed by the body and is a reliable and accurate way to understand your exposure to RF energy. It is an industry-standard test, and we are committed to ensuring our SAR levels remain well under regulated levels. To serve our mission of helping you keep your baby safe, we strive to ensure we meet and exceed all applicable regulatory requirements.