NeuroWave Systems Inc. receives UL and CSA Approval of its NeuroSENSE Monitoring System, Model NS-701
CLEVELAND HEIGHTS, Ohio (October 2010) - NeuroWave Systems Inc. announced that NeuroSENSE Monitoring System, Model NS-701 has received UL and CSA approval.
The NeuroSENSE Monitoring System, Model NS-701, is a bilateral non-invasive electroencephalographic (EEG) device to monitor the brain function in the operating room, intensive care unit, emergency room and other clinical settings. This system acquires, records, displays and processes real-time EEG signals on both sides of the forehead with 4 proprietary electrodes. The brainwaves are analyzed using NeuroWave's proprietary WAVCNS (Wavelet Analysis Value for Central Nervous System) index, providing clinicians with the second-by-second brain status and trends for both brain hemispheres. This aids the anesthesiologist, neurologist, doctor, or nurse by providing a simple 0-100 score of the patient's brain activity. The WAVCNS may be used as an aid in monitoring the effects of certain anesthetic agents on adult patients.
To obtain the UL and CSA certifications, the NeuroSENSE Monitoring System, Model NS-701 was rigorously tested over the course of several months by an accredited product conformity assessment organization to independently evaluate the NeuroSENSE's published performance claims and confirm the product's safe operation in extreme conditions.
"At NeuroWave Systems, patient and operator safety is our foremost concern. It is always a triumph to see the fruits of our labor realized and validated" said Charles Stirling, NeuroWave Systems' Software Manager.
Successfully completing the formal UL and CSA approval process is a major step forward as it is a known symbol of safety worldwide. "The UL/CSA Listing is where we start. We continue working to ensure our products remain safe and compliant" said Sankar Barua, NeuroWave Systems' Senior Embedded and Electronics Engineer.
The product itself was evaluated and tested for conformance with the appropriate standards including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-4, IEC 60601-2-26, UL 1876 and CAN/CAS C22.2 No. 601.1. NeuroWave Systems was also required to demonstrate that their Quality Management System and the associated Quality controls would assure that all future products continue to conform. "Utilizing strict quality controls throughout our manufacturing process is key to assuring our products meet UL and CSA requirements. Our comprehensive testing guarantees a high quality product with optimal performance for our customers." said Anton Milovan, NeuroWave Systems' Senior Electronics Technician.
The UL and CSA Marks on our medical equipment will prove to be a valuable tool in gaining market acceptance. No other safety certification marks have earned the same level of recognition from regulators, buyers, and consumers.
About NeuroWave:
NeuroWave Systems Inc. is focused on developing improved clinical brain
monitoring devices. The Companys mission is to develop, manufacture,
and market monitoring products using advanced signal processing of
brain waves (electroencephalogram - EEG) and other biosignals for
Neurology, Anesthesia, Emergency Medicine and Psychiatry applications,
in order to improve patient outcome and quality of life.