At 24/11/98 09:10 AM, you wrote: >From: Chris Hartzog <[email protected]> >Subject: The regulatory effect of distribution strategies > > My company develops, manufactures, sells and installs >FDA approved medical devices in the US which integrate with hospital >patient monitoring systems to capture and broadcast via a wireless >system patient alarm data. Our system in no way manipulates this data, >but simply passes it on to a pager or GSM cell phone carried by the >caregiver. > Please be aware that, apart from complying with the Medical and EMC directive, the application of GSM cell phones in a medical system might cause some problems. In most hospitals in the Netherlands the use of GSM cell phones is prohibited. This is not by law but it is a policy of the hospitals. The reason for this seems to be that a lot of (older) equipment used in hospitals does not have sufficient immunity to high frequency radio signals which has a digital kind of modulation. I don't know if the same situation exists in other countries in the EC.
Pieter Robben
