Affirm Upright

Affirm® Upright Breast Biopsy Guidance System

Transition from screening to interventional procedures for optimal system versatility 

This simple add-on to any Hologic 3D Mammography™ capable system enables quick 2D or 3D™ breast biopsies using the same imaging equipment as for mammography exams. Plus, the lateral arm upright biopsy accessory offers even more flexibility to access challenging lesions.

Stereotactic

Features

Superior image quality

Superior image quality4

Pinpoint subtle lesions and faint calcifications—including those that may only be visible with tomosynthesis with the 3D™ biopsy option.

Streamlined workflow

Streamlined workflow

Efficient, fast, easy to learn and use. The system provides a simplified user interface to deliver a fast biopsy with fewer steps and a lower patient dose.5

Versatile Solution

Versatile Solution

Transition from screening to interventional procedures to biopsy a wide spectrum of patients either seated or decubitus. Quickly and easily switch between standard and lateral needle approaches.

Increased confidence

A large field of view for high-resolution stereotactic 2D or 3D™ images makes visualizing suspicious areas fast and simple.

Fast and easy to use5

Intuitive user interface, fully integrated with the Selenia® Dimensions® and 3Dimensions™ systems, minimizes procedure steps and simplifies workflow with an average procedure time of 13 minutes.

Designed to remove the guesswork

Settings for all Hologic biopsy needle devices are pre-programmed, for quick setup and efficient operation, eliminating mental math with less chance for errors.

Access challenging lesions

Access challenging lesions with the optional lateral arm accessory. It installs quickly to present the needle parallel to the detector–especially valuable for thinly compressed breasts. 

Affirm lateral arm

Affirm® Lateral Arm Upright Biopsy Accessory

Confidently target challenging lesions and successfully biopsy thinly-compressed breasts. This versatile, easy-to-use device enables needle access parallel to the detector – from either the lateral left or lateral right position. Choose the optimal approach based on each patient’s anatomy and lesion location to accelerate and simplify biopsy procedures. 

Left

Accessory Features

Flexible patient positioning

Positioning patients in constrained spaces is always the challenge. The Affirm lateral arm offers a number of options in biopsy rooms where decubitus positioning or rotating the C-arm may not be possible. Patients can often remain seated without sacrificing lesion accessibility. 

Intuitive needle visualization

Experience improved 3D™ visualization of the biopsy needle in the breast with virtually no imaging artifacts as found in the standard approach. By presenting the needle parallel to the detector, it’s easier to see the needle aperture and more intuitive to make adjustments. 

Tech Specs
Tech Specs  
Biopsy Volume  
Standard or Axillary Paddle 5 cm x 5 cm x 10 cm
Wide Access Paddle 6 cm x 7 cm x 10 cm
Compression Method Motorized and Manual Compression
Compression Range Up to 15 cm
Image Area 18 cm x 24 cm
Breast Positioning Area 24 cm x 29 cm
SID 70 cm
Weight < 7kg (< 15lb)
Breast Biopsy Guidance  
Needle Guidance Cartesian Coordinate System Z-Axis has 10° tilt
Accuracy +/-1 mm
Stereotactic Angle +/-15°
C-Arm Positioning +180° to -140°(stereo start locations)
Guidance Movements X- and Y-Axes: Motorized Z-Axis: Manual
Range of Movement 75 mm (width) x 70 mm (depth) x 160 mm (height)
Home Positions Far Left, Far Right
Biopsy Field Illumination Integrated LED
Biopsy Control Module  
Display Window Touchscreen Color LCD 800 pixels x 600 pixels
Lesion Coordinate Display Numeric, Cartesian
Display Mode Target Guidance, Jog Screen, Select Targets
Acquisition Workstation  
Workflow Display 1.2 MP Touchscreen Color or Standard Color LCD display
Image Display 2 MP or 3 MP Medical Grade LCD DICOM Display
Biopsy Device Compatibility  
Needle Length Up to 140mm
Biopsy Compression Paddles  
Standard Biopsy Paddle  
Compression Area 14 cm x 18 cm
Biopsy Opening 5.4 cm x 5.2 cm
Standard Biopsy Paddle  
Compression Area 14 cm x 18 cm
Biopsy Opening 7.4 cm x 6.2 cm
Axillary Biopsy Paddle  
Compression Area 9.4 cm x 18 cm
Biopsy Opening 5.4 cm x 5.2 cm
Environmental Conditions  
Operating Temperature 20º to 30º C
Operating Relative Humidity 20% to 80%, non-condensing
Storing Temperature -10º to 40º C
Requirements  
Selenia® Dimensions® system diagnostic license and dynamic tube head motion license for biopsy  
Accessories  
Geometry Calibration Phantom  
Targeting Phantom  
Quality Assurance Needle  
Needle Guide Holder  
Affirm Biopsy License (single gantry)  
Tabletop Stand  
User Manual  
Service Manual  
Optional Components  
Lateral Arm Enables needle access parallel to the detector from either the lateral left or right position
Biopsy Device Mounting Standard adapters used on MultiCare® Platinum and Digital StereoLoc® II
Software Options A rm 3DTM Biopsy License (single gantry)
Additional A rm 3DTM Biopsy License (single gantry)
Additional A rm Stereotactic Biopsy License (single gantry)
Environmental Conditions  
Operating Temperature 20˚ to 30˚ C
Operating Relative Humidity 20% to 80%, non-condensing
Storing Temperature -10˚ to 40˚ C

Your Complete Biopsy Solution

Choose Your Method: Stereotactic Ultrasound MRI

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breast biopsy guidance system?