RomiApex A-15, User Manual, Page: 12 / 14

Rev. 05 -
Page 11 of 12
- 09/10
10 Storage - Keep devices in
sterilization packaging
in a dry and clean
environment.
- Sterility cannot be guaranteed if
packaging is open or damaged
(check the packaging before using
the instruments).
7. Certification
RomiApex™ A-15 is tested for compliance with IEC 60601-1:1988 safety standard, and
IEC 60601-1-2:2007 (Electromagnetic compatibility), including conducted and radiated
immunity tests as specified for equipment of Group 1 Class B.
RomiApex™ A-15 is covered by the "CE Marking of Conformity Certificate", reference
number: 5017.04.01/0 issued on 09.06.2006 and delivered by MDC Medical Device
Certification GmbH, Notified Body Identification number 0483. The device bears following
CE identification mark:
0483
8. European Authorized Representative
European Authorized Representative who has been empowered to enter into commitments
on our behalf:
Romidan (UK) LTD.
122-126 Tooly Street, London Bridge
London SE1 2TU,
United Kingdom
Fax:
+44 (0) 207-403-1026 / 1028
Email: export@romidan.com
Website: www.romidan-dental.com
Contact Person: Mr. Eitan Margalit, General Manager
9. Limited Warranty
RomiApex™ A-15 is warranted for 24 months from the date of purchase. The accessories
(cables, battery etc.) are warranted for 6 months from the date of purchase.
The warranty is valid for normal usage conditions. Any damage caused by accident, abuse,
misuse, or as a result of service or modification other than by a person authorized by the
manufacturer will render the warranty void. The warranty is in lieu of any other warranty
expressed or implied.
Any modifications made to the equipment without explicit approval from Romidan LTD
voids warranty obligations and poses a potential safety threat to both operator and patient.