Mammo 3D Performance Kit

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Mammo 3D Performance Kit

Comprehensive Quality Control for Digital Breast Tomosynthesis Systems

The Mammo 3D Performance Kit fulfills the tools needed for IEC 61223-3-6 (ED1) tests, and is a component of the Mammo 3D Quality Control Package — a complete solution for all your Tomosynthesis QC needs.



A kit for your IEC 3D acceptance testing needs


Criteria for acceptance testing of 3D Tomosynthesis Mammography systems has been internationally defined by the IEC, per protocol 61223-3-6. To fulfill these tests, a variety of tools are required, some of which are unique to Digital Breast Tomosythesis (DBT).

The Mammo 3D Performance Kit includes several PMMA plates, spacers, aluminum plates and foils, steel plates, and a variety of customized test tools. It was designed to comply with:

  • IEC Protocol 601223-3-6
  • EUREF 1.03
  • EUREF 4th Edition 2B
  • German DIN 6868-14

Perform 3D Acceptance Testing per IEC Requirements

Following is a list of IEC tests, and the applicable Mammo 3D Performance Kit equipment to support each test.

IEC Test Test Frequency Mode Supporting Mammo 3D Performance Kit Equipment
7 - Visual inspection and functional check Annual - -
8 - Alignment and collimation checks Annual Standard Tomosynthesis 1 - Stainless Steel Plate; 1 - X-ray Ruler
9.2 - AEC-system: Short term reproducibility Annual Standard Tomosynthesis 1 - Standard Test Plate
9.3 - AEC-system: Long term reproducibility Weekly Standard Tomosynthesis 1 - Standard Test Plate
9.4 - AEC performance Annual Zero Degree Angle Stationarymode, if applicable 7- 10 mm PMMA Plates; 1 – 5 mm PMMA Plate; 1 - 0.2 mm Aluminum Foil Sheet; 1 - X-ray Ruler; 7 - 2 mm PMMA Plates; 2 - 30 mm PMMA Spacers; 2 - 10 mm PMMA Spacers
10.1 - Image receptor: Response function On Acceptance Only Zero Degree Angle Stationarymode, if applicable 1 - Standard Test Plate; 1 - 2 mm Aluminum Plate
10.2 - Image receptor: element failure Annual - -
10.3 - Image receptor: Uncorrected defective detector elements Annual Zero Degree Angle Stationarymode, if applicable 1 - Standard Test Plate
10.4 - System projection MTF Annual Standard Tomosynthesis 1 - 2 mm Aluminum Plate; 1 - MTF Edge Tool
11.1 - Image quality of the reconstructed image: Phantom testing Daily Standard Tomosynthesis Mammo FFDM Phantom (sold separately)
11.2 - Image quality of the reconstructed image: Z-resolution Annual Standard Tomosynthesis 6 - 10 mm PMMA Plates; 1 - Z-Resolution Phantom
12.2 - Missed tissue at chest wall side in the reconstructed image Annual Standard Tomosynthesis 1 - X-ray Ruler
12.3 - Missed tissue at the top and bottom of the reconstructedtomosynthesis image Annual Standard Tomosynthesis For Flat Compression Paddles: 1 - spool (100 cm) of 50 microndiameter Tungsten wire; 6 - 10 mm PMMA Plates. For Curved Compression Paddles: 1 - spool of 50 micron Tungsten wire; Polystyrene Foam Spacers.
13.2 - Artifacts in the reconstructed tomosynthesis image: Artifactevaluation Weekly Standard Tomosynthesis 1 - Standard Test Plate
13.3 - Artifacts in the reconstructed tomosynthesis image: Geometricdistortion On Acceptance Only Standard Tomosynthesis 6 - 10 mm PMMA Plates; 1 - Z-Resolution Phantom
14 - Dosimetry for digital breast tomosynthesis Annual Zero Degree Angle Stationarymode, if applicable 7 - 10 mm PMMA Plates; 1 - Standard Test Plate; 1 - X-ray Ruler; 7 - 2 mm PMMA Plates; 1 - Dosimeter (sold separately)

Specifications

PMMA Plates, Spacers, & Phantoms

Material Quantity
Standard Test Plate (320 x 260 x 45 mm) 1
10 mm PMMA Plate (320 x 260 x 10 mm) 7
5 mm PMMA Plate (320 x 260 x 5 mm) 1
2 mm PMMA Plate (40 x 20 x 2 mm) 7
10 mm PMMA Spacers (150 x 15 x 10 mm) 2
30 mm PMMA Spacers (180 x 30 x 30 mm) 2
Geometric Distortion & Z-Resolution Phantom 1

Aluminum Plates & Foils

Material Quantity
2 mm Aluminum Plate (200 x 200 x 2 mm) 1
0.2 mm Aluminum Foil Sheet (10 x 10 x 0.2 mm) 1
0.1 mm Aluminum Foil Sheets 8

Steel Plates

Material Quantity
3 mm Stainless Steel Plate (320 x 260 x 3 mm) 1
MTF Edge Tool (120 x 60 x 0.6 mm) 1

Wire, Spacers, X-ray Rulers

Material Quantity
25 micron Tungsten Wire (cm) 100
Polystyrene Foam Spacers (240 x 180 x 20 mm) 4
1mm scale X-ray Rulers (+5 to -5 cm) 4

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