IEC 60601-2-50:2000 pdf free download

IEC 60601-2-50:2000 pdf free download
IEC 60601-2-50:2000 pdf free download.Medical electrical equipment
The instructions for use shall
– inform the OPERATOR about the necessity of temperature measurements on the PATIENT , if the PHOTOTHERAPY EQUIPMENT will influence the body temperature of the PATIENT ;
– contain information about the distance between the PHOTOTHERAPY EQUIPMENT and the EFFECTIVE SURFACE AREA . If the distance between the PHOTOTHERAPY EQUIPMENT and the EFFECTIVE SURFACE AREA is adjustable, the manufacturer has to describe how the operator can keep to the permissible distances;
– inform the OPERATOR about the impact of PHOTOTHERAPY EQUIPMENT on the heat supply in thermotherapy devices (incubators, radiant heaters, heated mattresses) and on the PATIENT ‘s body temperature;
– inform the OPERATOR that the use of the skin-controlled mode of the incubator, an infant radiant warmer or heated mattresses is recommended, otherwise the set air temperature of the incubator or the heater output of the radiant warmer or heated mattress has to be reduced according to body temperature measurements;
– contain details informing the USER or the OPERATOR about the limited lifetime of the radiation source;
– contain information about the maintenance intervals to make sure the radiation source will be changed after a decrease of 25 % of its TOTAL IRRADIANCE FOR BILIRUBIN E bi stated in the documents;
– contain the notice that if there are several lamps in a PHOTOTHERAPY EQUIPMENT , all lamps have to be changed when the expected lifetime has been exceeded;
– contain the notice that the lamps which are recommended by the manufacturer shall be used and that the use of other lamps, which are not approved by the manufacturer, can influence the safety and effectivity of the phototherapy;
– contain a graphical representation including figures of the size of the EFFECTIVE SURFACE AREA and its position with respect to the PHOTOTHERAPY EQUIPMENT ;
– indicate the total spectral irradiance E bi emitted by the PHOTOTHERAPY EQUIPMENT and averaged over a wavelength interval of 5 nm for the wavelength range between 320 nm and 550 nm. A graphical representation is desirable;
– include the calibration curve of the measurement device in the integral TOTAL IRRADIANCE FOR BILIRUBIN E bi emitted by the PHOTOTHERAPY EQUIPMENT measured under the condition of 50.103;