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Hello,
We are working on a product that will be taken home and worn by pateints continuousally. My concern is that it appears to be impossible to comply with the safe temperature limits of IEC EN 60601.
The basic concern is the limit of 50C for a patient contact device. However, temperatures in California and Arizona exceed this temperature from time to time. Further, a device left in a car or in the sun will exceed this temperature pretty reguarly. For this reason, any temperature rise for a device used outside technically fails.
Am I missing some exclusion for ambient temperature or some maximum temperature rise caused by the device as opposed to the environment?
Thanks,
Mike
We are working on a product that will be taken home and worn by pateints continuousally. My concern is that it appears to be impossible to comply with the safe temperature limits of IEC EN 60601.
The basic concern is the limit of 50C for a patient contact device. However, temperatures in California and Arizona exceed this temperature from time to time. Further, a device left in a car or in the sun will exceed this temperature pretty reguarly. For this reason, any temperature rise for a device used outside technically fails.
Am I missing some exclusion for ambient temperature or some maximum temperature rise caused by the device as opposed to the environment?
Thanks,
Mike