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Avacen 100 - Ec Declaration of Conformity

Avacen 100
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171208
2
Man
u
Auth
o
This
d
Mod
e
Risk
C
We
h
relev
requ
i
This
d
EN IS
EN 6
0
EN IS
We
h
asse
s
2. T
h
the E
haza
r
Plac
e
Man
u
Sign
a
Nam
e
Posit
Date
:
4.
EC DE
C
1. In ac
u
facturer:
o
rized Re
p
d
eclaratio
n
e
l Designa
t
C
lass:
h
ereby de
c
ant provis
rements
o
d
eclaratio
n
O 13485:
2
0
601-1-11
O 10993-
5
h
ave prese
s
sment as
p
h
e object
o
uropean
P
r
dous sub
s
e
of issue:
u
facturer:
a
ture:
e
:
i
on:
:
C
LARATI
cordance
t
p
resentati
v
n
of confo
r
t
ion:
c
lare that t
ions of st
a
o
f 93/42/E
n
is based
2
016, EN I
S
:2010, EN
5
:2009, IS
O
nted our
p
per Anne
x
o
f the decl
a
P
arliamen
t
s
tances in
Sa
n
A
V
Th
o
C
E
26
ON OF C
t
o 93/42/
E
AVA
C
9835
San
D
v
e: Medi
Schif
f
Ger
m
r
mity is is
s
AVA
C
Class
he produ
c
a
ndards a
n
EC.
on:
S
O 14971:
2
62366:20
0
O
10993-1
0
p
roduct a
n
x
II of 93/4
a
ration d
e
t
and of th
e
electrical
a
n
Diego, C
A
V
ACEN Inc.
o
mas Mu
e
E
O
October
2
AVACEN
ONFOR
M
E
EC as am
e
C
EN Inc.
Carroll Ce
D
iego, CA
9
cal Device
f
graben 4
1
m
any
s
ued unde
C
EN 100
IIa per 93
/
c
t to whic
h
n
d other n
o
2
012, EN
6
0
8, EN 60
6
0
:2010, E
N
n
d our syst
2/EEC as
a
e
scribed a
b
e
Council
o
a
nd electr
o
A
, USA
e
hlbauer
2
016
100 User
G
M
ITY
e
nded for
ntre Rd #
1
9
2126 US
A
Safety Se
r
1
, 30175 H
r the sole
/
42/EEC,
A
h
this decl
a
o
rmative
d
6
0601-1:2
0
6
01-1-6:2
0
N
62304:2
0
008
6
em to not
a
mended.
b
ove is in
c
o
f 8 June
2
o
nic equi
p
G
uide
Medical
D
1
04
A
r
vice Gmb
annover
responsib
i
A
nnex IX r
u
a
ration rel
a
d
ocument
(
0
06/A1:2
0
0
10, EN IS
O
0
06/A1:20
6
ified body
c
onformit
y
2
011 on th
p
ment.
D
evices
H
i
lity of the
u
le 9
a
tes is in
c
(
s) and ful
f
13, EN 60
6
O
10993-1:
15
BSI(0086)
y
with Dire
e restricti
o
manufac
t
c
onformit
y
f
ills the es
s
6
01-1-2:2
0
2009/AC:
2
for confo
e
ctive 201
1
o
n of the
u
2
t
urer:
y
with the
s
ential
0
15,
2
010,
rmity
1
/65/EU o
f
u
se of cer
t
2
3
t
ain
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