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10.3 Certificado de conformidad
10.3 Certificado de conformidad
1.
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System integrator (system installer)
Company, address
Name, address
Component
Requirement /
Approval
IEC 60 950-1 and CE marking
according to Council Directive
Manuf.
89/336/EEC
Type
No.
IEC 60 950-1 and CE marking
Manuf.
according to Council Directive
89/336/EEC
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Council Directive 93/42/EEC
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Council Directive 93/42/EEC
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Council Directive 93/42/EEC
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Council Directive 93/42/EEC
Type
No.
IEC 60 950-1 and CE marking
Manuf.
according to Council Directive
89/336/EEC
Type
No.
IEC 60 950-1 and CE marking
Manuf.
according to Council Directive
89/336/EEC
Type
No.
IEC 60 950-1 and CE marking
Manuf.
according to Council Directive
89/336/EEC
Type
No.
1.
supported by SIDEXIS, function required only if not performed by an additional server
Declaration acc. to Medical Devices Directive (MDD) 93/42/EEC and IEC 60 601-1-1 item 3.201.4
The undersigned herewith certifies that the above system consisting of CE-marked medical devices has been assembled in accordance with the present manufacturer's instructions,
that it has been tested for its intended use and that all relevant user information including pertinent information provided by the corresponding manufacturers has been provided for
placing it on the market, and that this declaration shall be kept on hand for the competent authorities for a period of five years.
Place, date
Name of system integrator
D 3352.128.01.04.02
12.2010
1. Rellene el certificado de conformidad.
El integrador de sistemas certifica la conformidad con
los requisitos de la UE del sistema SIDEXIS instalado
mediante la lista de compatibilidades.
La lista está establecida de forma que sólo deben
rellenarse los campos en blanco. La lista original
permanece en la consulta y la copia se la queda
el integrador de sistemas.
Sólo para Alemania:
Realice la comprobación de recepción descrita en la
normativa radiológica §16. Para ello, utilice el fantoma,
la placa enchufable, los elementos de contraste y el
fantoma de aguja suministrados, así como las respectivas
instrucciones.
* En Alemania, guárdese en el libro del equipo de rayos X.
140
Operator
fulfilled?
Technical
fulfilled?
Inst. regulations
fulfilled?
=yes
=yes
=yes
characteristics
Function test
IBM compatible PC with
For the Federal Republic of
DualCore 1 GHz,
Germany:
RAM 1GB with Windows2000/
On-site installation accord-
XP/7 Professional/7 Ultimate;
ing to DIN VDE 0100-710
5 GB free hard disk space
Graphics card
1024 x 768,
16,7 Mio colors
(True Color),
128 MB
Refresh rate > 70Hz
Operating system:
according to the op. systems
approved in the installation
instructions
1
Removable disk drive
:
CD/DVD-ROM
Dual Layer
Display quality tested with
Min. screen diagonal 15" with
flatscreen,
SMPTE test image accord-
ing to the enclosed instruc-
17 " with CRT
Min. resolution 1280 x 1024
tions
Refresh rate > 70Hz
CRT: Dot mask min. 0,28mm
flat-screen monitor: Pixel pitch
0,30 mm x 0,30 mm
see Installation instructions
For the FRG:
Acceptance test according
to DIN V 6868-151; for all
countries: Acquisition gen-
eration with image storage
and display successful
see Installation instructions
For the FRG:
Acceptance test according
to DIN V 6868-151; for all
countries: Acquisition gen-
eration with image storage
and display successful
see Installation instructions
For the FRG:
Acceptance test according
to DIN V 6868-151; for all
countries: Acquisition gen-
eration with image storage
and display successful
see Installation instructions
For the FRG:
Acceptance test according
to DIN V 6868-151; for all
countries: Acquisition gen-
eration with image storage
and display successful
Device installed according
to manufacturer's instruc-
tions
Device installed according
to manufacturer's instruc-
tions
Device installed according
to manufacturer's instruc-
tions
Signature
(in block letters)
113 429
59 92 545 D 3352
Ä.-Nr..:
Instrucciones de instalación ORTHOPHOS XG 3D
Sirona Dental Systems GmbH
ready
Plus
/ XG
59 87 677 D 3352
D 3352.031.01.20.04
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