64 95 142 D3632
282
D3632
.
031.01.02
.
02 03.2016
14 Final work
Sirona Dental Systems GmbH
14.3 Filling in the certificate of conformity
Installation Manual ORTHOPHOS SL
14.3
Filling in the certificate of conformity
➢ Fill in the certificate of conformity.
The system integrator uses the compatibility list as evidence of the
installed system's EC conformity.
The list is structured in such a way that only the white fields need to
be completed. The original list remains in the practice, the copy is
given to the system integrator.
Only for Germany
➢ Perform the acceptance test prescribed in the X-ray Ordinance §16.
Use the test phantom, plug-in plate, contrast elements, needle
phantom and relevant instructions included in delivery for this
purpose.
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loqelmelp=pi=Pa=L=`ÉéÜ
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Declaration acc. to Medical Devices Directive (MDD) 9
3
/42/EEC and IEC 60 601-1 item 16.1
The undersigned herewith certifies th
a
t the
a
bove system consisting of CE-m
a
rked medic
a
l devices h
a
s been
a
ssembled in
a
ccord
a
nce with the present m
a
nuf
a
cturer’s instructions,
th
a
t it h
a
s been tested for its intended use
a
nd th
a
t
a
ll relev
a
nt user inform
a
tion including pertinent inform
a
tion provided by the corresponding m
a
nuf
a
cturers h
a
s been provided for
pl
a
cing it on the m
a
rket,
a
nd th
a
t this decl
a
r
a
tion sh
a
ll be kept on h
a
nd for the competent
a
uthorities for
a
period of five ye
a
rs.
Pl
a
ce, d
a
te
N
a
me of system integr
a
tor
(in block letters)
S
ign
a
ture
S
ystem inte
g
rator (system installer)
Comp
a
ny,
a
ddress
Operator
N
a
me,
a
ddress
Component
Requirement /
Approval
fulfilled?
=yes
Technical
characteristics
fulfilled?
=yes
Inst. re
g
ulations
Function test
fulfilled?
=yes
PC unit
M
a
nuf.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Council Directive
89
/
33
6/EEC
IBM comp
a
tible
PC
with
DualCore 2 GHz
,
RAM
≥
4GB,
Windows 7 Profession
a
l/Ulti
-
m
a
te/
8
.1 Profession
a
l (64bit)
≥
500GB free stor
a
ge sp
a
ce
For the Feder
a
l Republic of
Germ
a
ny:
On-site inst
a
ll
a
tion
a
ccord
-
ing to DIN VDE 0100-710
Type
Graphics card
≥
12
8
0 x 1024,
≥
16,7 Mio
colors (True Color),
≥
512 MB
Refresh r
a
te > 70Hz
No.
Operatin
g
system:
a
ccording to the op. systems
a
pproved in the inst
a
ll
a
tion
instructions
Removable disk drive
1
:
DVD-ROM
DVD-RAM
1.
supported by
S
IDEXI
S
, function required only if not performed by
a
n
a
ddition
a
l server
Monitor
M
a
nuf.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Council Directive
89
/
33
6/EEC
Min. screen di
a
gon
a
l 15" with
fl
a
tscreen,
17 " with CRT
Min. resolution 12
8
0 x 1024
Refresh r
a
te > 70Hz
CRT: Dot m
a
sk min. 0,2
8
mm
fl
a
t-screen monitor: Pixel pitch
0,
3
0 mm x 0,
3
0 mm
Displ
a
y qu
a
lity tested with
S
MPTE test im
a
ge
a
ccord
-
ing to the enclosed instruc
-
tions
Type
No.
loq
elmel
p=
pi=
Oa=
L=`É
éÜI
loqelmelp=
pi=Pa=L
=`ÉéÜ
M
a
nuf.
S
iron
a
Dent
a
l
S
ystems CE m
a
rking in compli
a
nce with
Council Directive
93
/42/EEC
see Inst
a
ll
a
tion instructions
For the FRG:
Accept
a
nce test
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
countries: Acquisition gen
-
er
a
tion with im
a
ge stor
a
ge
a
nd displ
a
y successful
Type
No.
M
a
nuf.
S
iron
a
Dent
a
l
S
ystems CE m
a
rking in compli
a
nce with
Council Directive
93
/42/EEC
see Inst
a
ll
a
tion instructions
For the FRG:
Accept
a
nce test
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
countries: Acquisition gen
-
er
a
tion with im
a
ge stor
a
ge
a
nd displ
a
y successful
Type
No.
M
a
nuf.
S
iron
a
Dent
a
l
S
ystems CE m
a
rking in compli
a
nce with
Council Directive
93
/42/EEC
see Inst
a
ll
a
tion instructions
For the FRG:
Accept
a
nce test
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
countries: Acquisition gen
-
er
a
tion with im
a
ge stor
a
ge
a
nd displ
a
y successful
Type
No.
M
a
nuf.
S
iron
a
Dent
a
l
S
ystems CE m
a
rking in compli
a
nce with
Council Directive
93
/42/EEC
see Inst
a
ll
a
tion instructions
For the FRG:
Accept
a
nce test
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
countries: Acquisition gen
-
er
a
tion with im
a
ge stor
a
ge
a
nd displ
a
y successful
Type
No.
Other d
e
vices op
tio
nall
y co
nne
cted
to
t
h
e PC (
p
rint
er
, LA
N...)
M
a
nuf.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Council Directive
89
/
33
6/EEC
Device inst
a
lled
a
ccording
to m
a
nuf
a
cturer’s instruc
-
tions
Type
No.
M
a
nuf.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Council Directive
89
/
33
6/EEC
Device inst
a
lled
a
ccording
to m
a
nuf
a
cturer’s instruc
-
tions
Type
No.
M
a
nuf.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Council Directive
89
/
33
6/EEC
Device inst
a
lled
a
ccording
to m
a
nuf
a
cturer’s instruc
-
tions
Type
No.
D
3
6
3
2.12
8
.01.01.02
02.2015
Ä.-Nr..:
000 000
64
9
0
3
74 D
3
6
3
2
Operator's copy
