Free 3297 - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION

FIELD TEST SERIAL NO. (1-8)

HEAD AND NECK RADIOGRAPHIC SYSTEMS FIELD TEST RECORD (Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Card No. (9-10) Test Procedure 1. HN 11 Component Certification Information 2. Indicate the status of each as follows: C - Certified

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

HN
REGIONAL REVIEW (NAME)

V - Certified with a Variance X - Not Present or Not Applicable

13
N - Not Certified

Beam Limiting Device

High Voltage Generator

Cassette Holder

14
Tube Housing Assembly

15 18
X-ray Control Tube Housing Assembly With Beam Limiting Device

16
Other (Specify)

17 20

19

10
3. Indicated Source To Image Distance (SID)
q

inches

OR

q

cm

21

23

24

27

Test Setup

S6

Technique Factors 4. Timer mode of operation during testing

5.
kVp

29
6.

31
mA

28
M-manually set time or mAs P- phototimer MDH (Pulse Exposure) 4.5 mm Al Beam Quality 9.

32
7.
q

34
sec OR pulses

35
8.
mAs

38 44

39

41

42

q

mR

@

4.5 mm Al

45
10.
q

49
mR @ 3.5 mm Al

50
11.
q

54
mR @ 2.5 mm Al

55
12.
q

59
mR @ 1.5 mm Al

60
13. Techinque Factors indicated Before Exposure

64
14. Exposure Terminated After Preset Time Interval, Preset mAs, Or Preset Radiation Exposure To Image Receptor

11
15. Warning Label Present Y-YES N-NO

Y-YES N-NO

12

Y-YES N-NO

Reproducibility 17.
q

13

mR

18.

msec

15
16. MDH Threshould Setting, 0.53-3 phase, 0.2-1 phase 19.
q

19
mR

20
20.

23
msec

24
21.
q

28
mR

29
22.

32
msec

11

33
0
q

37
q

38
mR

41
msec

46

23.

24.

42

46

47

50
PAGE 1 of 3 PAGES
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FORM FDA 3297 (4/84)

EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION

FIELD TEST SERIAL NO. (1-8)

HEAD AND NECK RADIOGRAPHIC SYSTEMS FIELD TEST RECORD (Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Reproducibility (Continued) 25.
q

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

HN
REGIONAL REVIEW (NAME)

mR

26. Data Here If Any Two Of Items 17, 19, 21, And 23 Differ By More Than 10 Percent Of Largest Value

msec

51
27.

55
q

56
28.

59
msec

11
29.

mR

60
q

64
mR

65
30.

68
msec

69
31.
q

73
mR

74
32.

77
msec

11
33.
q

15
mR

16
34.

19
msec

20
35.
q

24
mR

25
36.

28
msec

29

33

34

37

Linearity 37.
mA

38

40

42. Distance from Base of Test Stand To Face of Cassette Holder

q

cm

12

61
43. Distance from Face Cassette Holder to Image Receptor

64

If Change in mA Caues a kVp Shift, Readjust kVp Setting to Value Selected at Item 5 Above 38.
q

q

cm

65
mR

67

41
39.
q

45
mR

44. Outside Separation of Image of Focal Spot Strips

q

cm

68

70

46
40.
q

50
mR

51
41.
q

55
mR

56

60

X-Ray Field/Indicated Field Size Comparison (Fixed Collimation Only) Indicated Field Size Horizontal Dimension

45.

q

inches

OR

q

cm

11
46. Indicated Field Size Vertical Dimension
q

13
inches

14
q

16
cm

17
47. X-Ray Field Image Horizontal Dimension
q

19
cm

20
48. X-Ray Field Image Vertical Dimension
q

22
cm

23

25

26

28

Actual Versus Indicated Field Size

13
49. Beam Limiting Device Numerically Indicates Field Size Indicated Field Size Horizontal Dimension Y-YES N-NO

29
inches OR cm

50.

q

q

30
51. Indicated Field Vertical Dimension
q

32
inches OR

33
q

35
cm

36
52. Light Field Horizontal Dimension
q

38
cm

39
Light Field Vertical Dimension
q

41
cm

53.

42

44

45

47

FORM FDA 3297 (4/84)

PAGE 2 of 3 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION

FIELD TEST SERIAL NO. (1-8)

HEAD AND NECK RADIOGRAPHIC SYSTEMS FIELD TEST RECORD (Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Illuminance 54.
total ambient

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

HN
REGIONAL REVIEW (NAME)

=
q

55.
fc

=
q

fc

48

50
57.
q

total

ambient

51

53

56.
total ambient

=
fc

=
q

fc

54

56

total

ambient

57

59

13

X-Ray Field/Light Alignment and Size Comparison 58. X-Ray Field Horizontal Dimension 60. Light Field Horizontal Dimension 62. Horizontal Misalignment
cm

q

60
q

62
cm

59. X-Ray Field Vertical Dimension 61. Light Field Vertical Dimension 63. Vertical Misalignment

q

cm

63
q

65
cm

66
q

68
cm

69
q

71
cm

72
X-Ray Field/Image Receptor Centers Comparison 64. Centers Misalignment

73

74

75

q

cm

11
PBL X-Ray Field/Image Receptor Size Comparison 65. Horizontal Film Dimension 66. Vertical Film Dimension 67. Indicated
SID
q

12

Inches

OR

q

cm

68. Type of Positive Beam Limitation (PBL) A. Automatically Adjusts X-ray Field B. Prevents Production of X-rays Until Manual Adjustments are Made

13
q

15
Inches OR

16
q

18
cm

19
q

21
Inches OR

22
q

24
cm

25

27

28

31
Y-YES N-NO

32

69. Is the PBL Currently Operating in Conformance with its Design

33

14

70. Distance from Film Cassette to Plastic Cassette

q

cm

34
71. Light Field Horizontal Dimension 73. Indicated SID
q

37
q

cm

38
q

40
Inches

72. Light Field Vertical Dimension
OR
q

cm

41
cm

43

44
74. Light Field Horizontal Dimension PBL Operation

46
q

47
cm

50
q

51

53

75. Light Field Vertical Dimension

cm

54

56

76. In PBL Mode, Adjustment Possible To Field Size Smaller Than Image Receptor

57

Y-YES N-NO

77. Automatic Return To PBL When Image Receptor is Changed

58 59
Y-YES N-NO

Y-YES N-NO

78. X-ray Production Prevented At SID's Where Operation Is Not Intended REMARKS

FORM FDA 3297 (4/84)

PAGE 3 of 3 PAGES