ProMed tens 1000 s Mode D'emploi page 142

140
CE-R
ICHTLINIEN
Das Gerät ist funkentstört nach
EG-Richtlinie 87/308/EG.
CE gemäß EG-Richtlinie
93/42/EWG, 2009/125/EG,
87/308/EG, 2006/95/EG,
2004/108/EG, 2002/95/EG,
1907/2006/EG und
2005/69/EG.
Die Anforderungen der EG-Richtlinie
93/42/EWG für die Klasse II
medizinische Produkte wurden erfüllt.
Geräte-Einstufung: Klasse IIa
DE
Angewandte Normen:
EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
US
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
FR
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IT
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
ES
DIN EN ISO 13485
| CE -D | D
IRECTIVES
The unit is equipped with radio interfe- Cet appareil est antiparasité con-
rence suppression in accordance with formément à la directive CE
the EC Directive 87/308/EC. 87/308/EC.
CE in accordance with EC Directive CE conformément à la directive CE
93/42/EEC, 2009/125/EC, 93/42/EEC, 2009/125/EC,
87/308/EC, 2006/95/EC, 87/308/EC, 2006/95/EC,
2004/108/EC, 2002/95/EC, 2004/108/EC, 2002/95/EC,
1907/2006/EC and 2005/69/EC. 1907/2006/EC et 2005/69/EC.
The requirements of the EC Directive Les spécifications de la directive CE
93/42/EEC for class II medical 93/42/EEC pour la classe II Produits
products has been fulfilled. médicaux ont été satisfaites.
Appliance classification: Class IIa Classement de l'appareil : Classe IIa
Standards applied: Normes appliquées :
EN 55011:1998 +A1:1999 +A2:2002 EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1-:2002 EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005 EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001 EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04 IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002 IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002 IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04 IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11 IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03 IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11 IEC 61000-4-11
Second Edition:2004-03 Second Edition:2004-03
09-2 03/2007 MDS-Hi 09-2 03/2007 MDS-Hi
DIN EN ISO 9001 DIN EN ISO 9001
DIN EN ISO 13485 DIN EN ISO 13485
CE | D
IRECTIVES IRETTIVE
L'apparecchio è schermato confor-
memente alla direttiva CE
87/308/EC.
CE conformemente alla direttiva CE
93/42/EEC, 2009/125/EC,
87/308/EC, 2006/95/EC,
2004/108/EC, 2002/95/EG,
1907/2006/EC e 2005/69/EC.
Sono stati soddisfatti i requisiti della
direttiva CE 93/42/EEC per la
classe II dispositivi medici.
Classificazione apparecchi: Classe IIa
Norme applicate:
EN 55011:1998 +A1:1999
+A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485
CE | D
IRECTRICES
El aparato es antiparásito según
la directiva CE 87/308/EC.
CE según la directiva CE
93/42/EEC, 2009/125/EC,
87/308/EC, 2006/95/EC,
2004/108/EC, 2002/95/EC,
1907/2006/EC y 2005/69/EC.
Este producto cumple las exigencias
de la directiva UE 93/42/EEC para
productos médicos de Clase II.
Clasificación del aparato: clase IIa
Normas aplicadas:
EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485
CE