Nursery Today magazine

Snuza receives Medical Device Certification for Snuza Hero

Distributed in the UK by Nimans Home, Snuza are delighted to announce receipt of the  Medical Device Certification for Snuza Hero, 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 onto the European market.

Snuza Hero Portable Baby Breathing Monitor is a wearable device which attaches to baby’s nappy and monitors abdominal movement. The Hero detects the slightest of movements and will alert parents if abdominal movement is weak or less than eight movements per minute. If the Snuza Hero detects no abdominal movement for 15 seconds it will vibrate in an effort to rouse  baby to resume abdominal movement. Often the vibration is enough to rouse the infant and Hero will revert to monitoring mode. However, after three vibration/rousing incidents, a Rouse Warning will alert parents that movement has stopped for 15 seconds on three occasions. If an additional 5 seconds of no abdominal movement is detected a sharp audible alarm will sound.

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 Hero satisfies all European regulatory requirements and offers parents the ultimate in piece of mind reassurance.

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