Acceptance Test - Siemens MAMMOMAT Novation DR Parts Replacement

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Acceptance test

Whenever a new MAMMOMAT Novation
changes are made to an existing system, it is recommended that the MAMMOMAT Nova-
DR
tion
acceptance test be performed.
The MAMMOMAT Novation
based on the part that was replaced. These procedures are described in this Quality
Control Manual and ensure that basic image quality criteria are met before the system is
used with patients.
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...).
MAMMOMAT Novation DR
DR
acceptance test includes a number of QC procedures,
SPB7-250.841.01.04.02
05.05
DR
system is installed or performance-affecting
Page 8 of 64
CS SD 24
Prerequisites
Siemens AG
Medical Solutions
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