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Siemens AG
SPB7-250.815.06.02.02
MAMMOMAT Novation DR
12.05
CS SD 24
Important Notes
11
Page 11 of 116
Medical Solutions
Special checks and protocols
0
Acceptance test
0
The acceptance test of the MAMMOMAT Novation
DR
is recommended to be performed
whenever a new MAMMOMAT NovationDR system has been installed and whenever
changes that might affect performance have been made to an existing system.
The acceptance test of MAMMOMAT Novation
DR
involves performance of all QC proce-
dures in this
Quality Control Manual
(SPB7-250.623.02...) ensuring that a basic mini-
mum image quality criteria is met before the system is used with patients.
All yearly tests from the
Quality Control Manual
have to be performed.
Depending on the country where the system is installed, additional tests have to be per-
formed.
•
Tests according to RöV §16 regulations must be performed in
Germany
.
•
Tests according to DHHS regulations must be performed in the
USA
.
Maintenance measurements must be made according to the
DHHS Maintenance
Instructions
(SPB7-250.662.01...) and the
DHHS Supplements to the instructions
for use
(SPB7-250.661.01...). Results must be recorded in
DHHS Measurement
certificates
(SPB7-250.663.01...).