171051(12) - Hillrom™ 900 Electric Bed Instructions for Use
Page 81
Appendix
Warranty and after sales service conditions
The warranty for our beds will be rendered null and void, in part or in total,
in the event of:
• Unauthorized interference with or incorrect maintenance of:
•
actuators,
•
electrical drives and components,
•
mechanical systems,
•
any abnormal use.
The details of after sales service contacts in your country are shown on the back
of this manual.
Compliance
• The CE mark was applied for the first time in 2010.
• CE mark applying to class I medical devices in accordance with
(see Declaration of Conformity):
- the Essential Requirements of the directive 93/42/EEC,
- the General Safety and Performance Requirements of the Regulation
(EU) 2017/745 regulation
• Complies with standards:
•
NF S 90-312 (1984),
•
EN 60601-1 (2006) & A1 (2013) / IEC 60601-1 (2005) & A1 (2012),
•
EN 60601-1-2 (2015) / IEC 60601-1-2 (2014),
•
EN 60601-2-52 (2010) / IEC 60601-2-52 (2009), application
environments 1, 2, 3 and 5, according to version,
• The LI900B2 and LI900B3 beds meet the NF MEDICAL - LITS
for "Hospital beds"
Authorization N°: NF178-01/01
- Certified characteristics:
• electrical safety precautions,
• electromagnetic compatibility,
• mechanical safety precautions,
• aptitude for use.
• The LI900B2 and LI900B3 beds meet the "NF Environnement -
Ameublement" standard
- Institut Technologique FCBA
10, rue Galilée
77420 Champs-sur-Marne
FRANCE
www.fcba.fr
