Intended User And Patient Population; Compliance With Medical Device Regulations; Emc Considerations; Ec Authorized Representative - Stryker F-ABSLT2BER Instructions For Use Manual

INSTRUCTIONS FOR USE
Indicates the Medical Device complies to
REGULATION (EU) 2017/745
Indicates a Warning
Intended to show when the IFU should be
referenced 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 the
safe working load specified in 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: 80028243
Version: B
Page 9
MDR 2017/745
IEC 60601-1
EN ISO 15223-1
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E