World’s first medically certified Portable Baby “Breathing Monitor” for Europe!
Snuza® – distributed in the UK by Nimans Home – are delighted to announce receipt of the Medical Device Certification for Snuza HeroMD, according to European Directive 93/42/EEC which means Snuza are the first company in the World to bring a fully certified Class IIb portable baby breathing monitor for Europe onto the European market.
Snuza® HeroMD baby monitor is a wearable device which attaches to your baby’s nappy and monitors your baby’s breathing. The HeroMD detects the slightest of breaths and will alert you if breathing is weak or less than eight breaths per minute. If the Snuza® HeroMD detects no breathing for 15 seconds it will vibrate in an effort to rouse your baby to resume breathing. Often the vibration is enough to rouse the infant and HeroMD will revert to monitoring mode. However after three vibration/rousing incidents, a Rouse Warning will alert you that breathing has stopped for 15 seconds on three occasions. If an additional 5 seconds of no breathing is detected a sharp audible alarm will sound.
Snuza HeroMD joins the family of Snuza® monitors including the Snuza®Go and the Snuza® Hero SE. The products are wearable and cordless and have various settings and functions, all manufactured according to strict standards and made from durable material that is safe for use on your baby.
The advanced technology in the Snuza® portable baby monitors combined with extensive experience and market feedback means Snuza is a device that offers peace of mind and support to parents when they are tired, worried and need help to monitor their baby.
Becoming certified is the culmination of 4 years of intensive work, where the Snuza® management system has been completely redesigned and certified to ISO 13485, while the product itself has undergone a major redesign with a number of added safety features to ensure it meets the highest standards of the European Medical Device Directives to which it was tested against.
The EU has been tightening the requirements for these kinds of products (which monitor physiological functions) and in some countries it is now forbidden to sell non-certified breathing/movement monitors. The new status of Snuza HeroMD satisfies all European regulatory requirements and offers parents the ultimate in piece of mind reassurance.