www.malmsten.com
Malmsten AB • www.malmsten.com
+46 44 28 71 00 • [email protected]
v.47
-23E
GENERAL WARNINGS
1
Swimming Pool Lift
DEVICE
i-swim2
MODEL
Page
4
of
38
1.3
DECLARATION OF CONFORMITY
A copy of this Declaration of Conformity is attached to the lift, signed and filled with the specific data.
CE DECLARATION OF CONFORMITY (FACSIMILE)
Original according to Directive 2007/47/CE
–
Annex VII
The undersigned Manufacturer:
AUTOLIFT SRL
Via Ferri 3
–
46020 Pegognaga (MN) - Italy
Tel. +39 0376 550375
–
Declares under its own responsibility that the medical device:
NAME ............................................................
SWIMMING POOL LIFT TO TRANSFER DISABLED PERSONS
MODEL ..........................................................
i-swim2
SERIES .........................................................
CLASSIFICATION
…...………………...
Class 1
YEAR OF CONS
TRUCTION……………...
It complies with the provisions of the following Community Regulations:
2007 / 47 / CE
Directive concerning medical devices
2004 / 108 / CE
Electromagnetic Compatibility Directive
The following harmonized standards have been applied:
UNI EN ISO 10535:2007
Swimming pool lift to transfer disabled persons - Requirements and test
methods
UNI CEI EN ISO 14971:2012
Medical devices - Application of risk management to medical devices
Pegognaga, (date)____________
Legal Representative
_________________________________
(Gabriele Ovi)