Intended User And Patient Population; Compliance With Medical Device Regulations; Emc Considerations; Ec Authorized Representative - Arthrex AR-1650S Gebrauchsanleitung

INSTRUCTIONS FOR USE
1.5.2

Intended User and Patient Population:

Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare
professionals involved in the device intended procedure. Not intended for Lay
persons.
Intended Populations:
This device is intended to be used with patients that do not exceed the weight in the
safe working load field specified in the product specification section 4.2
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: 80028287
Version: B
Page 11
Issue Date: 27 MAR 2020
Ref Blank Template: 80025118 Ver. E