ESPERANZA ZEPHYR ECN002, Руководство пользователя, Страница: 18 / 25

CE
DECLARATION OF CONFORMITY
DEKLARACJA ZGODNOSCI
We , the manufacturer/imp:,,ter (My, producent/importer):
EDC Poterek Sp . J a wna
ul . Pozn a n s k a 129 / 13 3
05-850 Ozarow Mazowieck i
Poland
Declares that the product (Dek l arujemy,ze produkt):
Kind
of
product (rodzaj produktu): COMPRESSOR NEBUUZER
Type designation (nazwa wfasna): ZEPHYR
Item No (numer / symbol): ECN002
Options (opcje) :
I s in compliance with the essential requirements and other relevant
provisions of the following directives :
Jest zgodny z zasadniczymi wymaganiami oraz fX)ZOSl.afy'mi
stosovvnymi przepisami nast ujqcych dyrektyw :
DIRECTIVE 9 3 /42/EE C ON M EDICAL DEVICES (MOO)
Y e ar o f iss u e ( la s t 2 di gi t s ) : 15
The products is compatible with the follO'Ning nonns/standards:
P rodukt jest zgodny z ponizszyrTii nonnami/standardami:
EN ISO 14971 : 2007
EN 60601 - 1:200 6
EN 60601 - 1 - 2 : 2007
E980 : 2008
1S013 48 5 : 2003
C E c
ert ifi ca t e:
www.espera n za.pl/C E/ EC N 00 2.pd f
-
Manufarurers/Authorised representative
Product Manager
Ozarow Mazowiecki 20-10-2015
Producent/ Produd l0< / Producer / VYrobce l Vj"robca
Produc t or / Gamintojas/ P rodutor l Producteur/ Gyilrt6
Produttorel Produzentl nopoywy6';10poKJBOA14Ten1>:
EDC Sp. Jawna.
0 5-850 0 ar6w Mazowieck i u l .
P oznarlska 129/133 www .espe r a n za.p l M AD E IN
P. R .C.
® 20 1 5 All rights reserved. Esperanza, E spe r anza l ogo and E speranza marks are owned by E 1 pera n za and may
be registered. All other trademarks are t he p r operty of their respective owners .