Intended User And Patient Population; Compliance With Medical Device Regulations; Emc Considerations; Ec Authorized Representative - Hillrom A-70207 Instrucciones De Uso

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)

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
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)

EU Importer Information:

Baxter Medical Systems GmbH + Co. KG
Document Number: 80028192
Version C
Page 10
Ref Blank Template: 80025117 Ver. F
Issue Date: 26 MAR 2020