Intended User And Patient Population; Emc Considerations; Ec Authorized Representative - Arthrex AR-6529S Bedienungsanleitung

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

1.6 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
Document Number: 80028286
Version: C
Indicates the manufacturer's
catalogue number
Indicates the need for the user to
consult the instructions for use for
important cautionary information such
as warnings and precautions
Indicates the device do not contain
natural rubber or dry natural rubber
latex
Indicates the authorized representative
in the European Community
Indicates the Medical Device complies
to REGULATION (EU) 2017/745
Indicates a Warning
Intended to show when the IFU
should be referenced for use
Page 9
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
EN ISO 15223-1
Issue Date: 31 MAR 2020
Ref Blank Template: 80025118 Ver. E