Free 3070 - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION MAMMOGRAPHIC SYSTEMS FIELD TEST RECORD (Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)

FIELD TEST SERIAL NO: (1-8)

Print Legibly. Use Black Ball Point Pen. Enter One Character per Box.

MA
REGIONAL REVIEW (NAME)

Card No.
(9-10)

Test Procedure: 1.

Component Certification Information 2. Indicate the status of each as follows: C -- Certified V -- Certified with a Variance X -- Not Present N -- Not Certified

MA
11 13

Beam Limiting Device 14 Tube Housing Assembly 16 X-ray Controls 18 19 17 15

Image Receptor Support Device High Voltage Generator

Other (Specify in Remarks)

Source-to-Image Receptor Distance

Date of Manufacture

10

3. 21

.

in

OR 23

22

.
26

4.
cm

Beam limiting device manufactured after October 1977

Y -- YES 27 N-- NO

Test Setup MDH (Pulse Exposure) mm Al over 50 kV - 3.0 below 50 kV - 1.5 Technique Factors 5. Timer mode of operation during testing 6.
kVp

28 7.

30
mA

If max kV is below 50, select max value. If max kV is above 50, select a value between 50 and 60.

31 M -- manually set time or mAs P -- phototimer

32 8. 35 9.

34

.
mAs

sec OR

pulses

38

39

41

42

44

Beam Quality 10. 11 11.

11
12.

18

26 13. 35 14. 42 Reproducibility 18. Threshold Setting

. . . . .
19.

mR

@

15
mR @

16

22
mR @

23

30
mR @

31

39
mR @

40

46

47

. . . . . . . . .

over 50 kV
mm Al

below 50 kV 15. Warning Label Present 1.5 mm Y -- YES 25 N-- NO

17
mm Al

3.0 mm

24
mm Al

2.0 mm

1.0 mm

16. Technique Factors Indicated Before Exposure 34 Y -- YES N-- NO

33
mm Al

1.5 mm

0.75 mm

17. Exposure Terminated After Preset 1.0 mm
mm Al

41

0.5 mm Time Interval, Preset mAs, Or Preset Number of Pulses 50 Y -- YES N-- NO

49

0.5 mm

0.25 mm

20.
mR

0

12

.

12 21. 11 23. 30 25. 39 21

16
mR

25
mR

If any of items 19, 21, 23, or 25 differ by more than 10 percent of the largest value, provide additional data at items 27 to 38

msec

17 22.

20
msec

26 24.

29
msec

34 26. 43
Page 1 of 2 pages

35

38

44

47
Created by: PSC Media Arts Branch (301) 443-2454

FORM FDA 3070 (10/80)

EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION MAMMOGRAPHIC SYSTEMS FIELD TEST RECORD (Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Reproducibility (Continued) 27. 11 29. 20 31.

FIELD TEST SERIAL NO: (1-8)

Print Legibly. Use Black Ball Point Pen. Enter One Character per Box.

MA
REGIONAL REVIEW (NAME)

13
33.

29

38 35. 47 37. 56

. . . . . .
mA

28.
mR msec

15 30.
mR

16

19
msec

24 32.
mR

25

28
msec

33 34.
mR

34

37
msec

42 36.
mR

43

46
msec

51 38.
mR

52

55
msec

60

61

64

Linearity 39. 11 13 If change in mA causes a kV shift, readjust kV setting (if possible) to value selected at item 6 above. 40. X-Ray Field/Image Receptor Alignment

44. 14
mR

.
LEFT EDGE

45.
cm

13
41.

20

25 42. 33 43. 38

. . . .

16

image receptor

17 19 RIGHT EDGE

.

cm

24
mR

29
mR

46. 30

.

cm

CHEST EDGE

32

37
mR

X-Ray field excess at each edge of image receptor

42

REMARKS

CHECK IF CONTINUATION SHEET USED

FORM FDA 3070 (10/80)

Page 2 of 2 pages