Technical Specifications

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

Integration profile: Scheduled workflow
Actor: Acquisition modality

  • Option: Assisted acquisition protocol setting
  • Option: PPS exception management
  • Option: Broad worklist query
  • Option: Patient-based worklist query

Integration profile: Patient information reconciliation
Actor: Acquisition modality

  • Option: None

Integration profile: Access to radiology information
Actor: Image display

  • Option: None

Integration profile: Portable data for imaging
Actor: Portable media creator

  • Option: None

 

Note: Tomosynthesis guided biopsy optional upgrade for 2D configuration.

Gantry and Generator Dimensions

Figures
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

Figure2
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)

 

Learn how the Affirm® prone biopsy system can help modernize your breast biopsy offerings.

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