10
Final work
Sirona Dental Systems GmbH
10.3
Declaration of Conformity
Installation Instructions ORTHOPHOS XG 3
60 51 416 D 3352
94
D 3352.031.03.18.02
1.
Complete the Declaration of Conformity.
The system integrator certifies the CE conformity of the
installed SIDEXIS system by means of the compatibility
list.
The list is designed so that only the white fields must be
filled in. The original list remains in the practice, the co
-
py is given to the system integrator.
Only for Germany
Perform the acceptance test required according to Art. 16
of the X-Ray Ordinance now. Use the test phantom, plug-in
plate, contrast elements, needle phantom and relevant
instructions included in delivery for this purpose.
* In Germany: File in the X-ray System Logbook.
10.3Declaration of Conformity
1.
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loqelmelp=ud=P=
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Ñçê=ÇáÖáí~ä=ê~ÇáçÖê~éÜó=ïáíÜ=pfabufp
Declaration acc. to Medical Device
s
Directive (MDD) 9
3
/42/EEC and IEC 60 601-1-1 item
3
.201.4
The
u
nder
s
igned herewith certifie
s
th
a
t the
ab
ove
s
y
s
tem con
s
i
s
ting of CE-m
a
rked medic
a
l device
s
h
as
b
een
ass
em
b
led in
a
ccord
a
nce with the pre
s
ent m
a
n
u
f
a
ct
u
rer
’s
in
s
tr
u
ction
s
,
th
a
t it h
as
b
een te
s
ted for it
s
intended
us
e
a
nd th
a
t
a
ll relev
a
nt
us
er inform
a
tion incl
u
ding pertinent inform
a
tion provided
b
y the corre
s
ponding m
a
n
u
f
a
ct
u
rer
s
h
as
b
een provided for
pl
a
cing it on the m
a
rket,
a
nd th
a
t thi
s
decl
a
r
a
tion
s
h
a
ll
b
e kept on h
a
nd for the competent
au
thoritie
s
for
a
period of five ye
a
r
s
.
Pl
a
ce, d
a
te
N
a
me of
s
y
s
tem integr
a
tor
(in
b
lock letter
s
)
S
ign
a
t
u
re
S
y
s
tem inte
g
rator (
s
y
s
tem in
s
taller)
Comp
a
ny,
a
ddre
ss
Operator
N
a
me,
a
ddre
ss
Component
Requirement /
Approval
fulfilled?
=ye
s
Technical
characteri
s
tic
s
fulfilled?
=ye
s
In
s
t. re
g
ulation
s
Function te
s
t
fulfilled?
=ye
s
PC unit
M
a
n
u
f.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Co
u
ncil Directive
89
/
33
6/EEC
IBM comp
a
ti
b
le
PC with
DualCore 1 GHz
,
RAM
t
1GB with Window
s
2000/
XP/7 Profe
ss
ion
a
l/7 Ultim
a
te;
t
5 GB free h
a
rd di
s
k
s
p
a
ce
For the Feder
a
l Rep
ub
lic of
Germ
a
ny:
On-
s
ite in
s
t
a
ll
a
tion
a
ccord-
ing to DIN VDE 0100-710
Type
Graphic
s
card
t
1024 x 76
8
,
t
16,7 Mio color
s
(Tr
u
e Color),
t
12
8
MB
Refre
s
h r
a
te > 70Hz
No.
Operatin
g
s
y
s
tem:
a
ccording to the op.
s
y
s
tem
s
a
pproved in the in
s
t
a
ll
a
tion
in
s
tr
u
ction
s
Removable di
s
k drive
1
:
CD/DVD-ROM
D
ua
l L
a
yer
1.
su
pported
b
y
S
IDEXI
S
, f
u
nction re
qu
ired only if not performed
b
y
a
n
a
ddition
a
l
s
erver
Monitor
M
a
n
u
f.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Co
u
ncil Directive
89
/
33
6/EEC
Min.
s
creen di
a
gon
a
l 15" with
fl
a
t
s
creen,
17 " with CRT
Min. re
s
ol
u
tion 12
8
0 x 1024
Refre
s
h r
a
te > 70Hz
CRT: Dot m
as
k min. 0,2
8
mm
fl
a
t-
s
creen monitor: Pixel pitch
0,
3
0 mm x 0,
3
0 mm
Di
s
pl
a
y
qua
lity te
s
ted with
S
MPTE te
s
t im
a
ge
a
ccord-
ing to the enclo
s
ed in
s
tr
u
c-
tion
s
Type
No.
loq
e
lmelp
=u
d=R
=L
=`
É
é
Ü
I
loqelmelp=u
d=P
=
M
a
n
u
f.
S
iron
a
Dent
a
l
S
y
s
tem
s
CE m
a
rking in compli
a
nce with
Co
u
ncil Directive
93
/42/EEC
s
ee In
s
t
a
ll
a
tion in
s
tr
u
ction
s
For the FRG:
Accept
a
nce te
s
t
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
co
u
ntrie
s
: Ac
qu
i
s
ition gen-
er
a
tion with im
a
ge
s
tor
a
ge
a
nd di
s
pl
a
y
su
cce
ss
f
u
l
Type
No.
M
a
n
u
f.
S
iron
a
Dent
a
l
S
y
s
tem
s
CE m
a
rking in compli
a
nce with
Co
u
ncil Directive
93
/42/EEC
s
ee In
s
t
a
ll
a
tion in
s
tr
u
ction
s
For the FRG:
Accept
a
nce te
s
t
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
co
u
ntrie
s
: Ac
qu
i
s
ition gen-
er
a
tion with im
a
ge
s
tor
a
ge
a
nd di
s
pl
a
y
su
cce
ss
f
u
l
Type
No.
M
a
n
u
f.
S
iron
a
Dent
a
l
S
y
s
tem
s
CE m
a
rking in compli
a
nce with
Co
u
ncil Directive
93
/42/EEC
s
ee In
s
t
a
ll
a
tion in
s
tr
u
ction
s
For the FRG:
Accept
a
nce te
s
t
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
co
u
ntrie
s
: Ac
qu
i
s
ition gen-
er
a
tion with im
a
ge
s
tor
a
ge
a
nd di
s
pl
a
y
su
cce
ss
f
u
l
Type
No.
M
a
n
u
f.
S
iron
a
Dent
a
l
S
y
s
tem
s
CE m
a
rking in compli
a
nce with
Co
u
ncil Directive
93
/42/EEC
s
ee In
s
t
a
ll
a
tion in
s
tr
u
ction
s
For the FRG:
Accept
a
nce te
s
t
a
ccording
to DIN V 6
8
6
8
-151; for
a
ll
co
u
ntrie
s
: Ac
qu
i
s
ition gen-
er
a
tion with im
a
ge
s
tor
a
ge
a
nd di
s
pl
a
y
su
cce
ss
f
u
l
Type
No.
Other d
e
vice
s
o
p
tio
nall
y c
onn
ected
to t
h
e PC
(prin
ter
, LA
N...)
M
a
n
u
f.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Co
u
ncil Directive
89
/
33
6/EEC
Device in
s
t
a
lled
a
ccording
to m
a
n
u
f
a
ct
u
rer
’s
in
s
tr
u
c-
tion
s
Type
No.
M
a
n
u
f.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Co
u
ncil Directive
89
/
33
6/EEC
Device in
s
t
a
lled
a
ccording
to m
a
n
u
f
a
ct
u
rer
’s
in
s
tr
u
c-
tion
s
Type
No.
M
a
n
u
f.
IEC 60
9
50-1
a
nd CE m
a
rking
a
ccording to Co
u
ncil Directive
89
/
33
6/EEC
Device in
s
t
a
lled
a
ccording
to m
a
n
u
f
a
ct
u
rer
’s
in
s
tr
u
c-
tion
s
Type
No.
D
33
52.12
8
.01.04.02
12.2010
Ä.-Nr..:
11
3
42
9
5
9
9
2 545 D
33
52
Operator'
s
copy
Содержание orthophos xg 3
Страница 1: ...NMKOMNR båÖäáëÜ kÉï ë çÑW loqelmelp ud P fåëí ää íáçå fåëíêìÅíáçåë T R Prog S kV mA P1 ...
Страница 5: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 5 1 Before you begin ...
Страница 13: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 13 2 Delivery and transport ...
Страница 19: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 19 3 Installation Panoramic X ray unit ...
Страница 45: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 45 4 Electrical connection ...
Страница 49: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 49 5 Installation Remote control ...
Страница 59: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 59 6 Safety checks ...
Страница 65: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 65 7 Initial startup ...
Страница 73: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 73 8 Startup for USA Canada only ...
Страница 83: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 83 9 Checking the system adjustment ...
Страница 91: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 91 10 Final work ...
Страница 97: ...ORTHOPHOS XG 3 60 51 416 D 3352 D 3352 031 03 18 02 97 11 Appendix ...
Страница 141: ......
