PROTEKPOWER

FSP Technology Inc., Kaohsiung Branch

2-3, East 3rd Street, N.E.P.Z., P.O. Box. 35-25, Kaohsiung, Taiwan, R. O. C.

ISO 9001 Certified

CE

DECLARATION OF CONFORMITY (DoC)

Object of the declaration:

External Power Supply

Family Name:

PMP400 series

Model Number:

PMP400-x-S; Where x = 13, 14, 15, 17, 18;

Compliance Statements:

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
93/42/EEC (Medical Devices Directive)	IEC 60601-1-2: 2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
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

Usage Note:

For use only in or with complete medical equipment where the acceptability of the combination is responsibility by manufacturer of the end-product.

Manufacturer Information:

Name of the Manufacturer: FSP Technology Inc., Kaohsiung Branch

Address of the Manufacturer: 2-3, East 3rd Street, N.E.P.Z., P.O. Box. 35-25, Kaohsiung, Taiwan

Declaration:

The undersigned, hereby declare that the equipment specified above conforms to the above Directive(s) and Standard(s)

13 September 2017

(Date)

(Signature)

Kaohsiung, Taiwan

(Place)

Bruce Chen, President

(Full Name, Position)

	FSP PM100 Series Internal Power Supply Declaration of Conformity Declaration of Conformity for FSP Technology Inc.'s PM100 series internal power supplies, confirming compliance with European Medical Devices Directive (93/42/EEC) and RoHS Directive (2011/65/EU) and relevant standards.
	FSP PMP400 Series AC-DC Power Supply CB Test Certificate This document is a CB Test Certificate (DE 2-040429) issued by TÜV Rheinland for FSP Group Inc.'s PMP400 series AC-DC Power Supplies. It confirms compliance with IEC 60601-1 and IEC 60601-1-6 standards, essential for medical electrical equipment. The certificate details product specifications, ratings, trademark (Protek Power), model variations (PMP400-x-S), and lists various manufacturing facilities.
	FSP PMP400 Series Switching Power Supply Verification of Compliance Verification of Compliance document for FSP PMP400 series switching power supplies, confirming adherence to various EMC and medical electrical equipment standards. Issued by SGS.
	FSP AC-DC Power Supply Safety Certificates - IEC 60601 & EN 60601 Compliance This document compiles safety certificates issued by TUV Rheinland for FSP Group Inc.'s AC-DC Power Supplies. The products are certified for compliance with key medical device standards, including IEC 60601-1 and EN 60601-1, ensuring suitability for medical applications. It details various model designations, manufacturing plants, and certificate validity periods.
	FSP Protek PMP400 Series AC-DC Power Supply CB Test Certificate Official CB Test Certificate (JPTUV-144771) for FSP's Protek PMP400 series AC-DC Power Supplies, confirming compliance with IEC 62368-1:2018. Details include applicant (FSP Group Inc.), manufacturer, factory locations, product ratings, and model variations.
	FSP Group Inc. CE Declaration of Conformity for Switching Power Supplies (FSP2000 Series) Official CE Declaration of Conformity from FSP Group Inc. for their Switching Power Supplies, models FSP2000-20FM, FSP2000-20HM, and FSP2000-29HM. This document confirms compliance with relevant EU directives and standards, including Low Voltage Directive (2014/35/EU) and EMC Directive (2014/30/EU).
	FSP Group Inc. CE Declaration of Conformity - Switching Power Supply Official CE Declaration of Conformity from FSP Group Inc. for their Switching Power Supply series, detailing compliance with key international safety and electromagnetic compatibility standards and EU directives.
	FSP PU101 Series Internal Power Supply Declaration of Conformity Declaration of Conformity for FSP Technology's PU101 series internal power supplies, confirming compliance with Low Voltage Directive (2014/35/EU) and RoHS Directive (2011/65/EU), meeting EN 62368-1 and EN50581 standards.

CE