Filling In The Certificate Of Conformity - Sirona ORTHOPHOS SL 2D Installation Manual

14 Final work
14.3 Filling in the certificate of conformity
Only for Germany
282
14.3

Filling in the certificate of conformity

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Company, address
Name, address
Component
Manuf.
Type
No.
Manuf.
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Type
No.
Sirona Dental Systems CE marking in compliance with
Manuf.
Type
No.
Manuf.
Type
No.
Manuf.
Type
No.
Manuf.
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 item 16.1
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
D 3632.128.01.01.02
➢ 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.
➢ 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.
Installation Manual ORTHOPHOS SL
System integrator (system installer)
Operator
Requirement / Technical
fulfilled?
=yes
Approval characteristics
IEC 60 950-1 and CE marking IBM compatible PC with
according to Council Directive DualCore 2 GHz,
RAM ≥ 4GB,
89/336/EEC
Windows 7 Professional/Ulti-
mate/8.1 Professional (64bit)
≥ 500GB free storage space
Graphics card
≥1280 x 1024, ≥ 16,7 Mio
colors (True Color), ≥ 512 MB
Refresh rate > 70Hz
Operating system:
according to the op. systems
approved in the installation
instructions
Removable disk drive
DVD-ROM
DVD-RAM
IEC 60 950-1 and CE marking Min. screen diagonal 15" with
according to Council Directive flatscreen,
89/336/EEC 17 " with CRT
Min. resolution 1280 x 1024
Refresh rate > 70Hz
CRT: Dot mask min. 0,28mm
flat-screen monitor: Pixel pitch
0,30 mm x 0,30 mm
see Installation instructions
Council Directive 93/42/EEC
see Installation instructions
Council Directive 93/42/EEC
see Installation instructions
Council Directive 93/42/EEC
see Installation instructions
Council Directive 93/42/EEC
IEC 60 950-1 and CE marking
according to Council Directive
89/336/EEC
IEC 60 950-1 and CE marking
according to Council Directive
89/336/EEC
IEC 60 950-1 and CE marking
according to Council Directive
89/336/EEC
Name of system integrator
(in block letters)
02.2015 000 000
Ä.-Nr..:
Sirona Dental Systems GmbH
Inst. regulations
fulfilled? fulfilled?
=yes =yes
Function test
For the Federal Republic of
Germany:
On-site installation accord-
ing to DIN VDE 0100-710
1
:
Display quality tested with
SMPTE test image accord-
ing to the enclosed instruc-
tions
For the FRG:
Acceptance test according
to DIN V 6868-151; for all
countries: Acquisition gen-
eration with image storage
and display successful
For the FRG:
Acceptance test according
to DIN V 6868-151; for all
countries: Acquisition gen-
eration with image storage
and display successful
For the FRG:
Acceptance test according
to DIN V 6868-151; for all
countries: Acquisition gen-
eration with image storage
and display successful
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
64 90 374 D 3632
64 95 142 D3632
D3632.031.01.02.02 03.2016