Compliance With Medical Device Regulations; Emc Considerations; Ec Authorized Representative; Manufacturing Information - Hillrom O-AHTR Instructions D'utilisation

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).

EMC considerations:

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

EC authorized representative:

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

Manufacturing Information:

ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)

EU Importer Information:

TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany

Australian sponsor Information:

Welch Allyn Australia Pty. Ltd.
Unit 4.01, 2-4 Lyonpark Road
Macquarie Park, NSW 2113
Phone 1800 650 083
Document Number: 80028133
Version: B
Page 10
Issue Date: 27 MAR 2020
Ref Blank Template: 80025117 Ver. F