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...).