Permobil X850 MiniFlex, Руководство пользователя

Страница: 11 / 128

Owner's Manual Permobil X850 MiniFlex Important Information about this Owner’s Manual
Incident reporting
If an incident occurs please contact your nearest Permobil representative. Normally the same person you contacted at
purchase day. To prepare this contact there is a link on our homepage, on the internet, at www.permobil.com. Open up
your country page and the contact page. Here is the needed contact information and a guidance document in what in-
formation we need to investigate the incident. Complete the information as much as possible. This is of great help for
us.
To increase the product quality and to ensure that our product is safe through the whole life cycle we need you to send
in Incident Reports. It is also stated in MEDDEV 2.12-1 and Annex 9 that the manufacturer shall
“Encourage users or
those given specific responsi-bility for reporting incidents that have occurred with medical devices and that meet the
criteria within these guidelines to report the incidents to the Manufacturer and or to the Competent Authority in accord-
ance with national guidance”.
To meet the requirements and to ensure that our products shall remain safe in your hands we need your assistance.
We hope you never need to use the information on this page but if there is an incident please contact us.
Product approval
This product fulfil the requirements according to EN 12184, EN 1021-1, EN 1021-2, ISO 7176-9:2009, ISO 7176–
14:2008, ISO 7176-16:1997 and ISO 7176-19:2001.
11