Safety is at the top of every parent’s mind when it comes to their baby so that little question “Is Bloomlife safe?” is a great question. As parents of new babies, we understand that you want the best for your little growing bundle and want to avoid anything that hasn’t been thoroughly tested.
So, in honor of you, rightfully cautious parent, we present complete transparency on the all the testing and regulatory approvals we have taken to make sure your baby is safe in there with Bloomlife nearby.
Ok, onto the safety stuff!
1. Safety of sensing mechanism
Unlike Doppler, ultrasound or radar based medical sensing technology, the Bloomlife sensor does not apply any electrical, acoustic or radio signals to perform the measurement. It passively “listens” to what’s happening at the surface of the Belly, which makes it safe for continuous use throughout pregnancy.
2. FCC and IC certification
The Bloomlife sensor uses a pre-certified Wireless module (PAN1322-SPP) and is compliant to FCC Part 15B, Part 15C and Canada ICES-003, RSS-247. Bloom obtained FCC and IC certification from an accredited test lab (SIEMIC Laboratories, Milpitas, CA) on August 25, 2015.
FCC (resp. IC) certification is required for commercialization of consumer electronic goods in the USA (resp. Canada) and demonstrates that the energy in the environment surrounding the device is maintained at a safe level.
3. Specific absorption rate
To further demonstrate Bloomlife’s safety on the pregnant body, we performed an additional Specific Absorption Rate (SAR) test to measure the electromagnetic energy that a device emits that may penetrate into the human body.
Our results have shown that the SAR value is <0.001 W/kg (1g) for the Bloomlife sensor attached on the belly. This value is more than 1000x lower than the safe limit value defined by FCC. The measurements were performed by an accredited test lab (SIEMIC Laboratories, Milpitas, CA), and concluded on October 3, 2015.
4. Biocompatibility (patch)
The Bloomlife patch uses a medical grade Silicone based adhesive from 3M (ref: 2476), typically used in clinical and surgical applications. A specific biocompatibility assessment for the continuous use of the Bloomlife patch during pregnancy demonstrating that the components, raw materials and ingredient substances in the Bloomlife patch pass toxicological safety tests according to ISO 10993-1 (for products intended for skin applications). This study concluded that the patch was safe for use throughout pregnancy – 9 months of continuous wear when changed once per week.
Do you have more questions? Drop us a note – firstname.lastname@example.org