P·6
II. SECURITY
2.1 STANDARDS AND GUIDELINES
All the safety information in this manual relates to the french legislation in force and
the provisions of the European Union. In other countries, it is necessary to respect the
corresponding legislations and provisions.
The LIGHTCHAIR II was manufactured in accordance with current technical regulations
for safe operation. The safety of the LIGHTCHAIR II is certified by CE and its declaration
of conformity.
2.2 DECLARATION OF CONFORMITY
As the manufacturer, Logo Silver declares under its own responsibility that the LIGHTCHAIR
II complies with specifications 93/42 and 2007/47 relating to European directives for medical
devices.
The design, development and manufacturing of the LIGHTCHAIR II are fully compliant in
terms of safety, by the following technical requirements:
• Risk analysis and management according to NF EN ISO 14971 standards
• Design requirements NF EN 12182 and NF EN 12184
• Dynamic stability, static stability, fatigue resistance test
• Product information: NF EN 12182 and NF EN 12 184
• Advertising documentation, use and maintenance guide, labeling, defining of energy
consumption, determination of speed, acceleration and deceleration, ability to climb the
maximum slope safely, ability to mount obstacles.
• Compliance with standards NF EN 12184 means, among other things, that the required
values for an inclination, the crossing of an obstacle, and speed, are reached or even
exceeded by the LIGHTCHAIR II.
NOTE
LIGHTCHAIR II checks and repairs must be carried out exclusively
by qualified personnel approved by the Silver Logo company. In the
event of any problem, please contact the specialist dealer which sold
you the product.
