Compliance With Medical Device Regulations; Emc Considerations; Ec Authorized Representative; Manufacturing Information - Arthrex Ar-6529S Manuel D'instructions

INSTRUCTIONS FOR USE

1.5.3 Compliance with medical device regulations:

This product is a non-invasive, Class I Medical Device. This system is CE-
marked according to Annex VIII, Rule 1, of the Medical Device
Regulations (REGULATION (EU) 2017/745)

1.6 EMC considerations:

This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.

1.7 EC authorized representative:

HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: +33 (0)2 97 50 92 12

1.8 Manufacturing Information:

ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
Document Number: 80028286
Version D
Page 10
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E