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ProMed Manuals
Blood Pressure Monitor
BDP-200
Instruction leaflet
Ce-Richtlinien S; Ce Directives - ProMed BDP-200 Instruction Leaflet
Upper arm blood pressure monitor
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Contents
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Available languages
EN
FR
ES
DE
IT
NL
PL
RU
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ENGLISH, page 20
FRANÇAIS, page 36
ESPAÑOL, página 68
DEUTSCH, seite 4
ITALIANO, pagina 52
DUTCH, pagina 84
POLSKI, strona 116
РУССКИЙ, страница 99
CE-R
| CE-D
ICHTLINIEN
D |
Die Anforderungen
der EU-Richtlinie
93/42/EWG in
Verbindung mit
der EU-Richtlinie
2007/47/EG für
Medizinprodukte
der Klasse Ila wurden
gemäß der Norm
EN 60601-1-2:2007
erfüllt.
CE gemäß den
EU-Richtlinien
2014/35/EU,
2014/30/EU,
2011/65/EU,
1907/2006/EG,
2005/69/EG,
93/68/EWG und
DE
2001/95/EG.
Das CE-Zeichen für
das Gerät bezieht
sich auf die
EN
EU-Richtlinie
93/42/EWG in
Verbindung mit
der EU-Richtlinie
FR
2007/47/EG.
Geräteklassifikation:
Klasse IIa.
Des Weiteren erfüllt
IT
das Gerät die
Anforderungen der
Normen:
IEC 60601-1:2012
ES
EN 60601-1:2006
+A1:2013
IEC 60601-11-
11:2010
NL
EN 66001-1-
11:2010
EN 1060-1:1995
+A2:2009
RU
EN 1060-3:1997
+A2:2009
EN 1060-4:2004
PL
TR
AR
| D
IRECTIVES
IRECTIVES
EN |
FR |
The requirements
Les exigences de la
of the EU Directive
directive
93/42/EEC in
UE 93/42/CEE
conjunction with
en combinaison
the EU Directive
avec la directive
2007/47/EC for
UE 2007/47/CE
class IIa medical
pour les produits
devices were met
médicaux de
according to the
la classe IIa ont
standard
été remplies
EN 60601-1-2:2007.
conformément
CE according to the
à la norme
EU Directives
EN 60601-1-2:2007.
2014/35/EU
CE conformément
2014/30/EU,
aux directives UE
2011/65/EU,
2014/35/UE,
1907/2006/EC,
2014/30/UE,
2005/69/EC,
2011/65/UE,
93/68/EEC and
1907/2006/CE,
2001/95/EC.
2005/69/CE,
The CE marking
93/68/CEE et
for the device
2001/95/CE.
refers to the
Le signe CE sur
EU Directive
l'appareil se réfère
93/42/EEC in
à la directive UE
conjunction with
93/42/CEE en
the EU Directive
combinaison avec
2007/47/EC.
la directive UE
Device classification:
2007/47/CE.
Class IIa.
Classification de
Furthermore, the
l'appareil: Classe IIa
device fulfils the
De plus, l'appareil
requirements of the
satisfait aux exigences
standards:
des normes:
IEC 60601-1:2012
IEC 60601-1:2012
EN 60601-1:2006
EN 60601-1:2006
+A1:2013
+A1:2013
IEC 60601-11-
IEC 60601-11-
11:2010
11:2010
EN 66001-1-11:2010
EN 66001-1-
EN 1060-1:1995
11:2010
+A2:2009
EN 1060-1:1995
EN 1060-3:1997
+A2:2009
+A2:2009
EN 1060-3:1997
EN 1060-4:2004
+A2:2009
EN 1060-4:2004
CE | D
CE | D
IRETTIVE
IT |
Sono soddisfatti
i requisiti della
Direttiva UE
93/42/CEE in
associazione
alla direttiva UE
2007/47/CE sui
dispositivi medici
della classe Ila, ai
sensi della norma
EN 60601-1-2:2007.
CE ai sensi delle
direttive UE
2014/35/UE,
2014/30/UE,
2011/65/UE,
1907/2006/
CE, 2005/69/
CE, 93/68/CEE e
2001/95/CE.
Il contrassegno CE
sull'apparecchio
si riferisce alla
Direttiva UE
93/42/CEE in
associazione
alla Direttiva UE
2007/47/CE.
Classificazione
dell'apparecchio:
classe IIa.
Inoltre, l'apparecchio
soddisfa i requisiti
delle norme:
IEC 60601-1:2012
EN 60601-1:2006
+A1:2013
IEC 60601-11-
11:2010
EN 66001-1-
11:2010
EN 1060-1:1995
+A2:2009
EN 1060-3:1997
+A2:2009
EN 1060-4:2004
148
CE
IRECTIVAS
ES |
Se ha cumplido con
los requisitos de la
Directiva
europea 93/42/CEE
en conjunción con
la Directiva europea
2007/47/CE para
productos médicos
de la clase IIa en
conformidad con la
norma
EN 60601-1-2:2007.
CE conforme con
las Directivas
europeas
2014/35/UE,
2014/30/UE,
2011/65/UE,
1907/2006/
CE, 2005/69/
CE, 93/68/CEE y
2001/95/CE.
El símbolo CE para
el dispositivo se
refiere a la
Directiva europea
93/42/CEE en
conjunción con la
Directiva europea
2007/47/CE.
Clasificación del
dispositivo: clase IIa.
Por lo demás el
dispositivo cumple
con los requisitos de
las normas:
IEC 60601-1:2012
EN 60601-1:2006
+A1:2013
IEC 60601-11-
11:2010
EN 66001-1-
11:2010
EN 1060-1:1995
+A2:2009
EN 1060-3:1997
+A2:2009
EN 1060-4:2004
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Deutsch
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English
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Français
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Español
67
Dutch
83
Table of Contents
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