For complete technical specifications and details on the Affirm® prone biopsy system, read below.
Overall System Specifications
| General Operating Conditions | |
|---|---|
| Temperature range | 10°C to 30°C (50°F - 86°F) |
| Max rate of temperature change | 10°C per hour |
| Relative humidity range | 10% to 80%, non-condensing |
Electrical Specifications
| System Protection | |
|---|---|
| Uninterruptable power supply | 700 VA, 420 W output power |
| Electrical Requirements | |
| Input line voltage | 200/208 /220/ 230/ 240 VAC ±10% |
| Average line current over 24 hours | < 5 A |
| Peak line current | 4 A (65 A maximum for < 5 seconds) |
| Frequency | 50/60 Hz ±5% |
General Specifications
| Acquistion Workstation | |
|---|---|
| CPU type | Multi-core |
| Memory | 4 GB |
| Hard drive size | 1 TB |
| Operating system | Windows 7/64-bit Embedded |
| Ethernet | 100/100 BASE-T Ethernet |
| Height range (Floor to work surface) | 71.1 cm (28 in) to 111.8 cm (44 in) |
| Adjustable vertical travel | 40.6 cm (16 in) |
| Adjustable type | Electronic |
| Removable storage | CD/DVD +/- R/W |
| USB ports | 6X USB 2.0 |
| Local image buffer | 2D Images: 200,000 images 3D™ Images: 5,000 images |
| Workflow display monitor | 17” 1280 x 1024 resolution |
| Image display monitor | 2 MP or 3 MP DICOM display |
X-ray Gantry Specifications
| Gantry Mechanics | |
|---|---|
| Gantry weight | 445 kg (980 lbs.) |
| Generator weight | 136 kg (300 lbs.) |
| Acquisition workstation weight | 114 kg (252 lbs.) |
| Patient Support Platform | |
| Type | Bidirectional patient positioning |
| Motorized height range | 86.4 - 145 cm (34 - 57 in) |
| Patient weight limit (lift and support) | 181.4 kg (400 lbs.) |
| Lighting | LED: Under table and biopsy field work light |
| C-arm | |
| Design | Fully integrated and independently rotating tube-arm, biopsy arm, detector mechanism |
| Lateral needle approach | Fully integrated into biopsy arm |
| Rotation | 180° continuous |
| Source-Image Distance (SID) | 80 cm (31.5 in) |
| Breast Compression | |
| Pre-compression | Motorized |
| Compression | Manual, handwheel driven |
| Release | Motorized |
| Controls | Handwheel or footswitch |
| Manual compression force | 67.4 lb. (300 N) maximum |
| Motorized compression force | 14 lb. (62.3 N) minimum 45 lb. (200 N) maximum |
| Paddles | 5 cm x 5 cm (biopsy window) standard 6 cm x 7 cm standard, 5 cm x 5 cm axillary 15 cm (total width) lateral |
Digital Image Receptor
| Technology | |
|---|---|
| Type | TFT-based direct capture |
| X-ray absorption material | Amorphous selenium |
| Image receptor size (H x W) | 33 cm (13 in) x 21.5 cm (8.46 in) |
| Field of view size | 14.3 cm (5.63 in) x 11.7 cm (4.6 in) |
| Pixel size | 70 μm |
| Limiting spatial resolution | 2D: 7.1 lp/mm 3D™ procedure: 7.1 lp/mm |
| Dynamic range | Linear response over greater than 400 : 1 dynamic range |
| Captured image bit depth | 14 bit |
| Geometric magnification | 1.18 |
| Storage Environment | |
| Storage temperature range | 10°C to 35° |
| Relative humidity range | 10% to 80%, non-condensing |
X-ray Subsystem
| Stand-Alone Generator | |
|---|---|
| Type | Constant potential three-phase high frequency inverter |
| Rating | 7.0 kW (large focus) maximum, at 34kV |
| Electrical power capacity | 9.0 kW maximum |
| 9.0 kW maximum | 20-49 kVp in 1 kVp increments |
| mAs Range | 3-500 mAs, 45 steps: 3.2, 3.6, 4, 4.5, 5, 5.6, 6.3, 7.1, 8, 9, 10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32, 36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110, 125, 140, 160, 180, 200, 220, 250, 280, 320, 360, 400, 450, 500 mAs |
| mA Range | 10-200 mA |
| X-ray Tube | |
| Anode Type | Tungsten |
| Focal spot size | 0.3 mm nominal |
| Filtration | Aluminum, 0.70 mm nominal Silver, 0.050 mm +/- 10% |
| Port | Beryllium |
Biopsy Guidance
| Specifications | |
|---|---|
| Needle guidance | Cartesian coordinate |
| Accuracy | +/- 1 mm |
| Stereotactic angle | +/- 15° |
| Tomosynthesis angle | +/- 7.5° |
| Guidance movements | 2 axis motorized, manual advance needle into the breast |
| Range of movement | Horizontal: -3.5 cm to +3.5 cm Vertical: 0 to 5.0 cm Needle: 0 to 10.0 cm |
| Biopsy control module | Color 1024 x 600 pixel resolution touch screen |
Acquisition Workstation
| Connectivity |
|---|
| DICOM services Print, query, storage, storage commitment, worklist |
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Integration profile: Scheduled workflow
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Integration profile: Patient information reconciliation
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Integration profile: Access to radiology information
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Integration profile: Portable data for imaging
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Note: Tomosynthesis guided biopsy optional upgrade for 2D configuration.
Gantry and Generator Dimensions
| Gantry/Patient Platform Dimensions | |
|---|---|
| A. Height | 107 cm (42 inches) |
| B. Width | 229 cm (90 inches) |
| C. Depth with C-arm | 178 cm (70 inches) |
| D. Overall Depth | 198 cm (78 inches) |
| Total Weight | 445 kg (980 pounds) |
| Generator Dimensions | |
| E. Height | 63 cm (25 inches) |
| F. Width | 87 cm (34 inches) |
| G. Depth | 55 cm (22 inches) |
| Total Weight | 136 kg (300 pounds) |
Acquisition Workstation Dimensions
| Acquisition Workstation Dimensions | |
|---|---|
| A. Height | 138.4 cm (54.5 inches) |
| Overall Height Range | 138.4 cm (54.5 inches) to 179.1 cm (70.5 inches) |
| Height Range (floor to work surface) |
71.1 cm (28 inches) to 111.8 cm (44 inches) |
| B. Width | 85.4 cm (34 inches) |
| C. Depth | 75.1 cm (30 inches) |
| Total Weight | 114 kg (252 pounds) |