Transformers medical apps and insulation monitor

EN60601 and 93/42/EWG

Electrical devices for applications connected to or placed close to patients must fulfill certain characteristics concerning maximum leakage current (<100µA in typical operation mode).
However, these defined values can be exceeded when several electrical units of different classes are used simultaneously (EN60601-1-1).

ALN/ALE insulating transformers offer an additional protection for patients, personnel and attached devices.

When used as leakage current limiters ALN/ALE reduce housing and ground leakage current in order to fulfill the critical values.

All ALN/ ALE devices are also certified for use with conventional low-voltage system, outside health care areas. The devices comply to the following standards (approved according to the standards of LGA InterCert GmbH, Nuremberg:

• EN60601-1, EN60601-1-1
• EN60601-1-2 (EMC)
• EN14971
• MDD 93/42/EWG, supplement I, VII.
  
  

All ALN/ALE devices already correspond to future requirements, since protective grounding is wired all the way from input to output plugs. For this reason ALN/ALE series, despite being characterized as insulating transformer, is approved for use medical appliances in health care environment.

A specially designed insulation monitor controls the insulation resistance (secundary winding). In case of lower limit failure the insulation monitor sets alarm acoustically and optically. Additionally the module serves as a transformer temperature monitor - possible overload or a lack of ventilation sets off the alarm as described above.