Equivital gets CE approval
A
Hidalgo product story
Edited by the Engineeringtalk editorial team
Dec 11, 2008
Equivital, an advanced remote physiological monitoring system, has achieved compliance with the stringent CE medical device standard ISO 13485-2003, in accordance with directive 93/42/EEC.
The Equivital system can now be used in a range of medical environments within a hospital facility, or at home as part of a telehealth system for monitoring long-term conditions, such as chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD).
Developed by Hidalgo and manufactured by Jaltek Systems in Luton (both companies are part of the Jaltek Group), Equivital is an ambulatory, wearable, high-performance physiological system, providing continuous real-time visibility of an individual's vital signs.
These include heart rate, 2-lead electrocardiogram (ECG), respiration rate and effort, temperature, body position, blood oxygen saturation, impact and fall detection.
Equivital can be integrated with a range of other 'point-in-time' measurement systems, including weighing scales and blood pressure monitors.
The wearer's physiological data can be communicated over a secured wireless network, for viewing by a healthcare professional, and is recorded onto an integral memory card.
Equivital has already been implemented in a range of demanding applications, and is suitable for applications ranging from telehealth, first responder and paramedical to occupational welfare, sports performance analysis and physical endurance research.
The CE marking follows on from registration with the US FDA (510k).
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