RIMSA OBSERVA ALFA-FIX User Manual

USER MANUAL FOR OBSERVATION LAMP
ALFA-FIX
ALFA-FLEX
RIMSA P. LONGONI s.r.l. - Via Monterosa, 18/20/22 – 20831 SEREGNO (MB) ITALY
Introduction
Dear User, you are kindly invited to read this manual carefully before proceeding to use the Product in
order to safeguard yourself and other people from any injuries.
This appliance is a Class 1 medical device pursuant to REGULATION (EU) 2017/745 on medical devices
(Annex VIII) as amended and integrated.
The manufacturer declares that this Product complies with Annex I (General Safety and Performance
Requirements) of REGULATION (EU) 2017/745 as amended and integrated and certifies such
conformity by affixing the CE marking.
The Product is classified in risk group 1 according to IEC 62471 standard (Photobiological Safety of
Lamps).
This User manual is valid for the following models:
- ALFA-FIX/ALFA-FLEX
L88-LED-M
- (GIMANORD)
- PRIMA-FIX/PRIMA-FLEX
The customer service is at your disposal in case of Product details, information concerning its use,
identification of spare parts being required and for any other queries you might have concerning the
appliance, for ordering spares and for matters relating to assistance and warranty.
RIMSA P. LONGONI SRL
Via Monterosa 18
I-20831 Seregno MB
Tel.: ++39 0362 325.709
Fax: ++39 0362 328.559
e-mail: info@rimsa.it
If the device causes the death or serious deterioration of the patient's or user's health conditions,
contact the manufacturer and the competent state authority where the event occurred.
The contents of this Manual may be amended by RIMSA, without prior notice or any further obligations,
in order to make changes and improvements. The reproduction and translation, including partial, of
any part of this manual is forbidden without the written permission of RIMSA.
RIMSA reserves the right to change, cancel or otherwise amend the data contained in this document
at any time and for any reason without prior notice inasmuch as RIMSA is constantly seeking new
solutions which lead to product evolution. RIMSA therefore reserves the right to make changes to the
supplied Product in terms of shape, fittings, technology and performances.
With regard to translations into languages other than Italian, reference shall always be made to the
Italian edition of this User manual.
USER MANUAL
OBSERVA SERIES
L88-LED-M
(GIMANORD)
Tel. +39 0362 325.709 Fax +39 0362 328.559
http://www.rimsa.it e-mail: info@rimsa.it
MO091-EN 15/05/24
Rev.6 Page 1 of 25
PRIMA-FIX
PRIMA-FLEX
EN