Medtronic Battery Support System 2, Руководство по эксплуатации

Страница: 7 / 36

Battery Support System 2 Operating Instructions v
©1999–2004 Medtronic Emergency Response Systems, Inc.
*
This declaration does not apply to military configuration catalog number 99407-000018
EC DECLARATION OF CONFORMITY
*
Manufacturer’s Name: Medtronic Emergency Response Systems, Inc.
Manufacturer’s Address: 11811 Willows Road NE
Redmond, WA 98052-2003 USA
declares that the CE-marked product
Product Name: Battery Support System 2
Model Number(s):
3010035
*
complies with 93/42/EEC (Medical Device Directive) class I, conformity assessed per Annex 7.
This product complies with:
Safety: EN 61010-1 1993 amd. 1995
−
Class I
−
Pollution degree 2
−
Installation Category II
EMC: EN 60601-1-2: 1993
Redmond, October 25, 2004
Michael D. Willingham
Vice President, Regulatory Affairs
This declaration applies to CE-marked devices produced after the date of issuance of this declaration and
before it is either superseded by another declaration or withdrawn.
Authorized EC Representative: Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands