GE Senographe DS Operator's Manual page 162

GE Healthcare
Revision 1
Maintenance
3-4 Telescoping gauge and gauge blocks
• A telescoping gauge can be used to locate the corner of the compression paddle that most closely
approaches the breast support surface after compression is applied to the test object. The telescop-
ing gauge is then stacked on an appropriate thickness of gauge blocks to test the distance between
each of the other three corners of the paddle and the support surface and to determine if the deflec-
tion of the paddle meets the specification. This gauge kit provides a "go-no go" test of the deflection.
• A minimum of one 10 ± 0.05 mm gauge block is needed to perform the test on a paddle that is
intended to remain flat and parallel to the breast support table [21 CFR 900.12(b)(8)(B)]. Additional
blocks of appropriate thicknesses (±0.05 mm) must be included for testing of paddles such as the
flexible paddle which are not intended to remain flat and parallel within the 1.0 cm deflection limit [21
CFR 900.12(b)(8)(C)], or to extend the telescoping gauge in the event that the gauge pin does not
contact the compression paddle with the pin fully extended from the gauge.
5 mm Gauge Block
(2 pieces)
3-5 Support plate
• Another element of the test set up is a support plate. This is based on the observation that the breast
support surface as well as the compression paddle will deflect during the compression. The intent is
to support the test object on a surface that is considerably more rigid than the compression paddle so
that the deflection of the paddle is measured and not the deflection of the base on which it rests. The
support plate should be large enough to completely cover the image receptor support device. A sheet
of acrylic with dimensions of about 25 cm x 30 cm x 1.9 cm thick (10 in x 12 in x 3/4 in) is suggested.
A 10 in x 12 in x 1/4-inch aluminum sheet could also be used for this purpose.
Chapter 15
10 mm Gauge Block
(2 pieces)
Page no. 162
Senographe DS Acquisition System
Operator Manual 5307907-3-S-1EN
Gauge pin
Set Screw
Telecoping gauge
15-maint.fm