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R&TTE Declaration of Conformity (DoC)
We, Name of company: Stryker Instruments
Address:
4100 East Milham Avenue, Kalamazoo, Michigan 49001-6197
Authorized Representative: Jean-Yves Carentz
Contact Detail of Authorized Representative: Stryker France, ZAC Satolas Green Pusignan,
Av. de Satolas Green, 69881 MEYZIEU Cedex, France
declare under our sole responsibility that the product:
Product Name: Total Performance System
Trade Name: Stryker Instruments
Type or Model:
5100-1 Console; 5100-50 Irrigation Console
Relevant supplementary information: EN/IEC 60601-1-2:2001 & EN 301-489-3:EN 300 330-2 v1.1.1
to which this declaration relates is in conformity with the essential requirements and other relevant requirements of the R&TTE
Directive (1999/5/EC).
The product is compliant with the following standards and/or other normative documents:
SAFETY (art 3.1.a): IEC 60601-1:1995 Medical Electrical Equipment
EMC (art 3.1.b): EN 301 489-3 v1.3.1 Specific Conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz
and 40 GHz.
SPECTRUM (art 3.2): EN 300 330-2 v1.1.1 Harmonized EN Covering Essential Requirements Under Article 3.2 of the R&TTE Direc-
tive
OTHER: ANSI C95.1 Safety Levels with Respect to Human Exposure to RF Electromagnetic Fields 300 kHz to 300 GHz
Supplementary information: None
Notified Body involved: TUV Rheinland Product Safety (GmbH)
Technical file held by: Stryker Instruments
Place and date of issue (of this Doc): Kalamazoo, Michigan USA, January 2004
Signed by or for the manufacturer:
Name (printed): Paul Freestone
Title: Director, Regulatory Affairs, Quality Assurance
Hereby, Stryker Instruments, declares that this Short Range Device is in compliance with the essential requirements and
other relevant provisions of Directive 1999/5/EC.
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