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The TMF 05 Series AC/DC power supply modules are designed and manufactured based on workmanship standards and risk management to comply with the requirements for quality, reliability and safety of medical equipment. The units are approved to IEC/EN/ES 60601-1 edition 3.2 for 2 x MOPP (Means Of Patient Protection) and come along with an ISO 14971 risk management file. These fully encapsulated modules are for PCB mount. They are designed for protection class II applications (no earth connection) and feature a low leakage current (<100 μA). A compact design and excellent EMC considerations facilitate the design in. The thermal management enables an operation within a wide temperature range of -25 to +70°C and the isolation system is designed and approved for an altitude of 5000 m (AMSL). This makes the power supplies suitable not only for stationary applications but also for transportable medical equipment.
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TRACOPOWER products do not generally fall under the REACH directive.
Our general REACH declaration is available via the following link:
TRACOPOWER completed successfully in July, 2006 the process of producing all power supply and dc/dc converter fully compliant to the European RoHS Directive (2002/95/EC). Excepted are those products which have been removed from the actual sales program (obsolete products).
The EU RoHS Directive and the China RoHS both denominate identical Substances and MCV’s (Maximum Concentration Values).
The current TRACO POWER RoHS declaration therefore satisfies the EU RoHS Directive as well as the China RoHS Regulation.
We generally do not recommend washing or cleaning electronic components. You should avoid it, if it is not absolutely necessary. Please refer to cleaning guide.
For those Power Supplies which fall under the Low Voltage directive (2014/35/EU) or the EMC directive (2014/30/EU) or ATEX directive (2014/34/EU) or RoHS directive (2011/65/EU) of the European Union TRACO Electronic AG provides a CE Declaration.
The following link will take you to the declarations of conformity for the selected product:
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10 Watt AC/DC modules, medical, 85-264 VAC input, 4000 VAC I/O-isolation (2xMOPP), low leakage current, encapsulated, PCB mount