User's Manual

EN-39
DRAFT
Frequency of transmission: 13�56MHz
Type of frequency / characteristics of the modulation: 10%ASK
Subcarrier: 423�75kHz, Manchester coding
Eective radiated power: 50µW
Industry Canada (IC)
IC: 4919C-XFLOW
Trade Name: CrossFlow Integrated Arthroscopy Pump
Type or Model: 0450000000
This device complies with Industy Canada license-exempt RSS standard(s)� Operation is subject to the
following two conditions: (1) this device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired operation of the device�
The term “IC” before the radio certication number only signies that Industry Canada technical
specications were met�
R&TTE Declaration of Conformity
We, Name of company: Stryker Endoscopy
Address: 5900Optical Court, San Jose, CA 95138
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: CrossFlow Integrated Arthroscopy Pump
Trade Name: CrossFlow Integrated Arthroscopy Pump
Type or Model: 0450000000
Relevant Supplementary Information: None
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: EN 60601-1
EMC: EN 60601-1-2
Radio Spectrum: EN 300 330-1 V1�5�1
Supplementary information: none
Notied body involved: TÜV Rheinland Product Safety (GmbH)
Technical le held by: Stryker Endoscopy
Place and date of issue (of this DoC): San Jose, CA USA, DATE
Signed by or for the manufacturer:
Name: Mike Hilldoerfer
Title: Associate Director, Regulatory Aairs
Hereby, Stryker Endoscopy declares that this Short Range Device is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC�