Free 3260 - Federal

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

FIELD TEST SERIAL NO: (1-8)

C-ARM FLUOROSCOPIC 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.

CF
REGIONAL REVIEW (NAME)

Card No.
(9-10)

Test Procedure: 1.

CF

2. System Type 14 13 Beam Limiting Device Information 3. BLD Manufactured after 5/22/79

M--Mobile

S--Stationary

11

Y--yes 15 1--Fixed Aperture 16 2--Stepless

N--no

4. BLD Type

Component Certification Information 5. Indicate the Status of Each as Follows: C--Certified N--Not Certified Tub Housing Assembly 17 Beam Limiting Device 20 Table 23 24 21 Image Intensifier (after 4/77) 18 High Voltage Generator 22 V--Certified with a Variance X--Not Present or not applicable X-Ray Control 19 Spot Film Device (after 4/77) Fluoroscopic Imaging Assembly

(before 4/77)

10

Initial Set-up (Fluoroscopic Mode) And Surveyor Protection Test MDH (Exposure)
S 6 C S 1

6. System Hazardous 25

Y--yes

N--no

I. I.

If yes, describe hazard in remarks and discontinue testing.
X

7. Warning Label Present 26

Y--yes

N--no

BLD/SSD SPACER

Fluoroscopic X-ray Field/Image Receptor Alignment Image Dimension 1/4 8. 27 2/1
2 3 1 4

X-ray Field Dimension

. . . .

in 29 in 35 in 41 in 47

12. 30 13. 36 14. 42 15. 48

. . . .

cm 32 cm 38 cm 44 cm 50

9. 33 10. 39 11. 45

3/2 4/3

NO MAGNIFICATION FORM FDA 3260 (2/83)
Created by: PSC Media Arts Branch (301) 443-2454

EF

PAGE 1 OF 4 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Print Legibly. Use Black Ball Point Pen. Enter One Character per Box. Do Not Write in Shaded Area.

FIELD TEST SERIAL NO: (1-8)

CF
REGIONAL REVIEW (NAME)

C-ARM FLUOROSCOPIC AND SPOT-FILM SYSTEMS FIELD TEST RECORD
(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Fluoroscopic X-ray Field/Image Receptor Alignment Image Dimension

X-ray Field Dimension

24. Visible Area: 75

1--Circular 2--Rectangular

10

16. 1/4 51 2/1 3/2 4/3 17. 57 18. 63 19. 69

. . . .

20. in 53 in 59 in 65 in 71 72 23. 66 22. 60 21. 54

. . . .

cm 56 cm 62 cm 68 cm 74 26. Maximum Cumulative Setting for Fluoro Timer is 5 minutes or less Y--yes N--no 77 25. Tube Potential and Current Continuously Indicated During Exposure Y--yes N--no 76

Primary Protective Barrier/X-ray Field Size Comparison

27. Diameter of the Image Intensifier Housing 28. Distance from face of I.I. to base of stand

11 14

. .

cm 13 cm 16

Minimum Fluoro Field Size

29. X-ray field Image length 30. X-ray field Image width 1--Circular 31. Field Shape 23

17 20 2--Rectangular

. .

cm 19 cm 22

11
Entrance Exposure rate: (BLD fully open, no magnification)
S 6 C S 1

32. Fluoroscopic Technique Factor Control Type
I. I.
X

24 M--Manual Only A--Automatic Only B--Both Manual and Automatic

BLD/SSD SPACER

MDH (Exposure rate) MANUAL
33. kVp 25 27 28 34. 35.

.

mA 29 30

.
35

R/min 33 Y--YES X--N/A N--NO

36. Is a high level control present?

34 kVp 39.

Y--YES Continuous Audible Signal Upon N--NO 37. Activation of High Level Control 40. 39

AUTO

38. 36 38

.

mA 40 41

.
46

R/min 44 Y--YES N--NO X--N/A

41. Is a high level control present?

45

Y--YES N--NO

42. Continuous Audible Signal Upon Activation of High Level Control

FORM FDA 3260 (2/83)

PAGE 2 OF 4 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Print Legibly. Use Black Ball Point Pen. Enter One Character per Box. Do Not Write in Shaded Area.

FIELD TEST SERIAL NO: (1-8)

CF
REGIONAL REVIEW (NAME)

C-ARM FLUOROSCOPIC AND SPOT-FILM SYSTEMS FIELD TEST RECORD
(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Source -- Image Distance and Minimum Source to Skin Distance

43. Distance from face of SSD spacer (or from face of BLD if spacer is not present) to top of brass strips 47

.

cm 49

44. Outside Separation of Image of Focal Spot Strips 50

.

cm 52

11
Beam Quality 47. 53
D

kVp 55
S 1

46. 56 48. 62 50. 68 70 64 58

mR @ 4.5 mm AI

47. 59

. . . . .
17

sec 61 sec 67 sec 73 sec 79 sec 16

mR @ 3.5 mm AI mR @ 2.5 mm AI mR @ 1.5 mm AI 74 76 mR @ 0.0 mm AI 11 13

49. 65 51. 71 53. 77 55. 14

I. I.

X

52. 54.

BLD/SSD SPACER

MDH (Pulse Exposure 4.5mm AI

44. At End of Present Cumulative Time Internal Either Continuous Audible Signal and/or Termination of X-rays

Y--YES N--NO

Spot-Film Mode

12

57. Type of spot-film device 1. Clip-on cassette holder 2. Cut-film changer 3. N/A (only a fluorographic camera provided) 18

58. Spot-film length 19 59. Spot-film width 22

. .

cm 21 cm 24

60. Technique factors fixed or selectable indicated before exposure 25 61. A visible beam-on indication during exposure 26 62. An audible indication of exposure termination 27 63. Exposure terminated at a preset time or mAs 64. Means provided for maintaining the fluoro field size during spot-filming

Y-yes Y-yes

N-no N-no

Y-yes

N-no

28 29

Y-yes Y-yes

N-no N-no X-N/A

FORM FDA 3260 (2/83)

PAGE 3 OF 4 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Print Legibly. Use Black Ball Point Pen. Enter One Character per Box. Do Not Write in Shaded Area.

FIELD TEST SERIAL NO: (1-8)

CF
REGIONAL REVIEW (NAME)

C-ARM FLUOROSCOPIC AND SPOT-FILM SYSTEMS FIELD TEST RECORD
(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Spot-Film Reproducibility and Linearity

47

.

cm 49

65. MDH Threshold Setting. 0.5-3 phase, 0.2-1 phase
C S 1

0

.

30

66. Generator Type

12
I. I.
X

31 67. Technique Factors kVp 32 34 mA
BLD/SSD SPACER

1-single phase 3-three phase

mAs 35 37

38

40

41

.

sec. 43

Reproducibility (no AI in beam) 68. 44 70. 60q 72. 11 74. 27 76.

. . . . .

mR 48 mR 64 mR 15 mR 31 mR 47

69. 49 71. 65 73. 16 75. 32 77. 48 50 34 18 67 51

msec msec msec msec

78. 52 80. 68 82. 19 84. 32

. . . . .

mR 79. 56 mR 81. 72 mR 83. 23 mR 85. 34 mR 87. 55 56 58 40 42 24 26 73 75 57 59

msec msec msec msec

msec

86. 51

msec

13

43 Linearity 88.

mA 62 59 If change in mA causes a kVp shift, readjust kVp (if possible) to value selected at Item

89. 63 91. 11

. .

mR 67 mR 15

90. 68 92. 16

. .

mR 72 mR 20

X-ray Field/Spot-film Size Comparison 93. Distance from the spot-film plane to the SSD spacer (or from face of BLD if spacer is not present) 21

.

cm 23

14

94. Distance from Image receptor to bottom of test stand

24

.

cm 26

95. Length 28 96. Width 31

. .

cm (For circular field enter diameter twice) 30 cm 33

REMARKS

FORM FDA 3260 (2/83)

PAGE 4 OF 4 PAGES