We are delighted to announce that our neonatal apnoea monitor has been fully approved to the medical device standards and a CE certificate has been issued. We thank all our customers for their patience during this lengthy process.
We already have a backlog of orders for this product, which is a replacement for the Graseby MR10 monitors that are no longer available, working in the same way and using the same principles. Manufacture is already underway and the first production build will be completed in the next few weeks, with a second build following immediately afterwards.
The RM15 is a neonatal respiration monitor for apnoea detection and uses a single patient use pneumatic sensor to detect movement of the infant’s abdominal wall, similar to the Graseby MR10. The user can set a delay period and if no signal is registered during this time period an alarm is generated. The monitor is indicated for use in babies and infants up to 18 months old, with no lower age or weight limit.
Delta Medical International customers are excited by the launch of this new apnoea monitor as they have been struggling to meet patient demand, due to falling numbers of serviceable Graseby MR10 devices in clinical use. This is already borne out by orders received for nearly all the first two substantial production builds.
Commenting on the approval, Delta Medical’s Sales & Marketing Director, Angie Haken, said: “Our new apnoea monitor means that clinical staff can continue to monitor patients at risk easily and reassure the parents of newborn infants in their care.”
More details can be found on the Neonatal Apnoea Monitor product page.