GE Senographe DS Operator's Manual page 29

GE Healthcare
Revision 1
1-6 Optional Accessories
Optional accessories available for the Senographe DS Gantry include:
- Optical localizer (consisting of 2D cross-hair localizer and 2D large localization paddle) for two
dimensional biopsy.
- Examination chair.
- Accessories storage unit.
- Remote handswitch.
- Bar code scanner.
- 2D large localization paddle.
- 2D spot localization paddle.
- Flexible 19x23 paddle.
The flexible paddle is designed to provide uniform compression from chest wall to nipple, by tilting
with respect to the Bucky as compression is applied. It is self-adjusting, and can be used in place of
the parallel paddle. The flexible paddle is not intended to remain flat and parallel to the breast sup-
port surface when compression is applied. It does, however, comply with MQSA Quality Mammogra-
phy Standard 21 CFR 900.12(b)(8)(ii)(C) regarding equipment intended by the manufacturer's design
to not be flat and parallel to the breast support surface.
To ensure continued performance of this compression paddle according to its specifications, the
tests described in Chapter
sion on page 161 should be performed at least once every year or when a loss in performance is sus-
pected. The test results must meet the following action limits:
• Minimum deflection 12 mm;
• Maximum deflection 14 mm.
! Notice:
To avoid any risk of premature failure, it is recommended that the 2D large localization paddle and
all spot paddles (7x7 square magnification, round spot magnification, and 2D spot localization)
should be used with a maximum compression force of 20 daN.
CAUTION
Only Senographe DS recommended paddles and accessories should be used with this
equipment. Failure to heed this warning may cause unexpected results and possible data
loss.
3-gantry.fm
15 Maintenance, section
Page no. 29
Senographe DS Acquisition System
Operator Manual 5307907-3-S-1EN
Senographe DS Gantry and Generator
3 Test for flexible paddle deflection in compres-
Chapter 3