Compliance With Medical Device Regulations; Emc Considerations; Ec Authorized Representative; Manufacturing Information - Skytron F-PTB2SKY Manual Del Usuario

INSTRUCTIONS FOR USE
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 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
Document Number: 80024535
Version: B
Page 9
Issue Date: 23 MAR 2020
Ref Blank Template: 80025118 Ver. E