DECLARATION OF CONFORMITY (DoC)
Object of the declaration: Internal Power Supply
Family Name: PM100 series
Model Number: PM100-x; Where x = 10A, 12A, 13A, 13-1A, 14A, 15A, 17A, 18A
The above mentioned product complies with the essential protection requirements of European Council Directive and standards used for this declaration are as follows:
93/42/EEC (Medical Devices Directive) | IEC 60601-1:2005/A1:2012 (EN 60601-1:2006/A1:2013) Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
2011/65/EU (RoHS Directive) | EN50581:2012 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances |
For use only in or with complete medical equipment where the acceptability of the combination is responsibility by manufacturer of the end-product.
Name of the Manufacturer: FSP Technology Inc., Kaohsiung Branch
Address of the Manufacturer: 2-3, East 3rd Street, N.Ε.Ρ.Ζ., Ρ.Ο. Box. 35-25 Kaohsiung, Taiwan
The undersigned, hereby declare that the equipment specified above conforms to the above Directive(s) and Standard(s)
13 September 2017 (Date)
Kaohsiung, Taiwan (Place)
(Signature) Bruce Chen, President (Full Name, Position)