Intended User And Patient Population; Compliance With Medical Device Regulations; Emc Considerations; Ec Authorized Representative - AMATECH F-70801 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)

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: D-720640
Version: D
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
MDR 2017/745
IEC 60601-1
EN ISO 15223-1
Issue Date: 16 AUG 2021
Ref Blank Template: 80025118 Ver. E