Transforming clinical diagnosis
01 May 2010
Electronic/electric medical equipment used in close proximity to patients must comply with the European Medical Devices Directive EN 60601 Parts 1-1-2 and 1-1/A2, which cover electromagnetic compatibility and general safety, respectively. This is to ensure the integrity of both connected and adjacent equipment in order to safeguard the patient.
Accordingly, trolley based diagnostic systems used in hospitals and medical centres must conform. This includes such products as the CT3000 non-invasive urodynamics diagnostics machine, from Mediplus of High Wycombe, which is used to diagnose bladder outlet obstruction and prostate related problems.
Mediplus’ CT3000 has recently been redesigned to incorporate the latest technology and achieve a reduction in overall size. Enhancements include a higher specification load cell to ensure greater precision and consistent performance, a medical PC and on-board printer. An integral part of the upgrade is the inclusion of a ‘REOMed’ medical isolation transformer from REO UK, which helps medical equipment manufacturers comply with EN 60601.
REOMed is manufactured from UL listed materials, and at its heart is a special isolation transformer, comprising a core of high-quality, electrical-grade strip steel. The transformer windings benefit from multi-layer isolation barriers and an earthed, screened winding to ensure the required dielectric strength of greater than 4kV and ‘general earth leakage current’ of less than 500uA is achieved. The transformer is encapsulated to ensure robustness and to avoid moisture ingress, and the entire assembly – including the fuses, four input/output sockets and mains switch - is housed within a metal enclosure.
Mediplus operations manager, Tim Ward acknowledges the role that REOMed played in the CT3000 upgrade. “It ensures compliance with EN 60601, is compact, has multiple power outlets and is available off the shelf,” he says. “REO also helped us during the design process by providing all the required drawings to ensure appropriate accommodation was designed in.”
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