Free 2786 - Federal


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

FIELD TEST SERIAL NO. (1-8)

UNDERTABLE X-RAY SOURCE FLOROSCOPIC AND SPOT FILM SYSTEMS FIELD TEST RECORD

(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)

Print Legibly. Use Black Ball Point Pen. Enter One Character Per Box. Do Not Write in Shaded Area.

UF
REGIONAL REVIEW (NAME)

Card No.
(9-10)

Test Procedure 1.

Beam Limiting Device Information 2. Manufacturer

Mfr. Code

UF
11 13
3.

14
Unique ID

17

Model No.

18

23

Component Certification Information 4. Indicate the Status of Each as Follows: C - Certified N - Not Certified V - Certified with a Variance X - Not Present

24 27

Tube Housing Assembly

25 28

X-Ray Control

26
Beam Limiting Device High Voltage Generator

Spot Film Device (after 4/77) Fluoroscopic Imaging Assembly (before 4/77)

29 30
Table

31

Image Intensifier (after 4/77)

10

Interlock Test 5. X-Ray Production Prevention When Image Receptor Not in Position to Intercept Beam

Y--YES

N--NO

X--UNTESTED

32
Surveyor Protection and Tracking Test:
v

6. Y--YES N--NO 33 If yes, describe hazard in Remarks and discontinue testing 7. Beam Limiting Device Tracks Image Receptor Properly System Hazardous

2 3
v

1 4

34

Y--YES N--NO

X-Ray Field/Image Receptor Alignment MDH (Exposure) 1/4 2/1
2 1 4
q

Image Dimension 8.
q

X-Ray Field Dimension 12. in. Image Intesifier Positioned at Worst Case SID. Data Here Only if Answer to Tracking Question (#7) is "NO". Otherwise Proceed with Data at 16-23. cm

q

9.

35

37
in.

13.

38
q

40
cm

S5

.
Insert Loaded Plastic Casette After Centering Test Stand. 24.

w

3

3/2

10.

41
q

43
in.

14.

44
q

46
cm

4/3

11.

47
q

49
in.

15.

50
q

52
cm

53
1/4 16.
q

55
20. in. Only Part of Test That Requires Magnification Mode. Take Out of This Mode After Completing the Test.

56
q

58
cm

Tube Potential and Current Continuously Indicated During Exposure

11
2/1 17.
q

13
in.

14
21.
q

16
cm

23

Y--YES

N--NO

17
3/2 18.
q

19
in.

20
22.
q

22
cm

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

24
4/3 19.
q

26
23. in.

27
q

29
cm

30

FORM FDA 2786 (5/82)

31 33 Page 1 of 3 pages

34

36
EF

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

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

FIELD TEST SERIAL NO. (1-8)

UNDERTABLE X-RAY SOURCE FLOROSCOPIC AND SPOT FILM SYSTEMS FIELD TEST RECORD

(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Entrance Exposure Rate: (BLD fully open, no 26. Fluoroscopic Technique Factor Control Type 27.
kVp
w

Print Legibly. Use Black Ball Point Pen. Enter One Character Per Box. Do Not Write in Shaded Area.

UF
REGIONAL REVIEW (NAME)

37

A--Automatic Only M--Manual Only B--Both Manual And Automatic 28.
q

AUTO

29. mA
q

S2

R/min

38
30. Is a high level control present?

40
Y--YES N--NO 33.
kVp

41

42
31.

43
Continuous Audible Signal Upon Activation of High Level Control 34.

46
Y--YES N--NO X--N/A R/min

11

.
MDH (Exposure rate)

47
MANUAL 32.

48

q

mA

q

49
35. Is a high level control present?

51
Y--YES N--NO

52

53
31.

54
Continuous Audible Signal Upon Activation of High Level Control

57
Y--YES N--NO X--N/A

58
Primary Barrier Transmission: 37.
kVp

59

min SSD: 39.
q

38. mA

42.
q

R/min

60
40.

62
q

63

64 41.

65
q

68

Outside Separtion of Image of Focal Spot Strips
q

mR sec 73 75 69 72 Copper appropriate for selected kVp: greater than 125 kV-0.12"; 100 to 125 kV-0.1"; 99 kV or less - 0.08". Beam Quality: 43.
kVp

cm

76

78

44.
mR

45. @ 4.5 mm Al
q

sec

11

13
46.

14

16
47.
mR

17
@ 3.5 mm Al
q

19
sec

20
48.

22
49.
mR

23
@ 2.5 mm Al
q

25
sec

26
50.

28
51.
mR

29
@ 1.5 mm Al
q

31
sec

32
52.

34
53.
mR

35
@ 0.0 mm Al
q

37
sec

MDH (Pulse Exposure) 4.5 mm Al

38 40 54. At End of Preset Cumulative Time Interval Either Continuous Audible Signal and/or Termination of X-rays

41 44

43
Y--YES N--NO

12
Spot-Film Reproducibility and X-ray Field/Image Receptor Size Comparison:
MDH (Pulse Exposure)

55. Type of Spot Film Exposure Timer

S2

43
56. MDH Threshold Setting Ø
q

M-- Manually Set Timer or mAs Selector only B -- Both Manually Set Timer or mAs Selector and Phototimer P -- Phototimer Only Technique Factors 57.
kVp

46
58. 59.

47
mA sec

49
mAs

60.

50

52
OR

53

55
cm

56
63. Image Along Table

58
cm

61. Selected Format in Dimension 59 61 Along Table 62. Selected Format Dimension in Across Table 68 70 65. Distance From Table Top to Spot Film Plane
q q

q

q

62
OR
q

64
cm 64. Image Across Table

65
q

67
cm

71
q

73
cm

74

76

77

79

FORM FDA 2786 (5/82)

Page 2 of 3 pages

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

FIELD TEST SERIAL NO. (1-8)

UNDERTABLE X-RAY SOURCE FLOROSCOPIC AND SPOT FILM SYSTEMS FIELD TEST RECORD

(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Spot-Film Continued: 66.
q

Print Legibly. Use Black Ball Point Pen. Enter One Character Per Box. Do Not Write in Shaded Area.

UF
REGIONAL REVIEW (NAME)

67. mR
msec

76.
q

77. mR
msec

11
68.

15
69.
q

16
mR

18
78.
msec

19
q

23
79. mR

24

26
msec

13
27
70.

31
71.
q

32
mR

34
80.
msec

35
q

39
81. mR

40

42
msec

43
72.
q

47
73. mR

48

50
82.
msec

51
q

55
83. mR

56

58
msec

59
74.
q

63
75. mR

64

66
84.
msec

67
q

71
85. mR

72

74
msec

11

15

16

18

19

23 27

14

86.

Technique Factors fixed or selectable Indicated Before Exposure Exposure Terminated After Preset Time Interval, Preset mAs, Preset Number of Pulses, Or Preset Radiation Exposure To Image Receptor

24 Y--YES N--NO

26

87.

28

Y--YES

N--NO

REMARKS

FORM FDA 2786 (5/82)

Page 3 of 3 pages