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New spectral benefi ts, proven low dose Philips MicroDose mammography SI, technical data sheet Philips MicroDose SI with single-shot spectral imaging is a fullfi eld digital mammography solution that delivers proven dose effi ciency, outstanding image quality, and novel spectral technology. Designed to delight physicians, patients, and mammographers, it helps deliver high-quality, effi cient, patient-focused care. The foundation of MicroDose SI is Philips proven photon counting technology enabling users to capture outstanding images at low dose. MicroDose SI adds a new advancement to this remarkable technology: non-invasive spectral imaging capability that holds promise of providing new insights into breast composition. Key advantages Proven: Experience outstanding image quality at a very low X-ray dose Objective: Refi ne your breast density assessment with spectral, volumetric, breast density measurement Non-invasive: Collect spectral data in a fast and comfortable mammogram

Table of contents 1 Gantry 4 1.1 Mammography stand 4 6 Dose configurations 8 6.1 Dose levels 8 2 Detector 6 2.1 Direct digital detector 6 3 Tube and generator 6 3.1 X-ray tube 6 3.2 High-voltage generator 6 3.3 Exposure control 6 4 Acquisition workstation 7 4.1 Acquisition workstation 7 5 Side cabinet 8 5.1 Side cabinet containing cooling system and electronics 8 7 Operating conditions 9 7.1 Electrical requirements 9 7.2 Operating environment 9 7.3 Transport and storage environment 9 7.4 Heat dissipation 9 8 Accessories 10 8.1 Compression paddles 10 8.2 Spectral breast density measurement 10 8.3 Diagnostic Scan 10 8.4 Needle examination package 10 8.5 Four pedals foot switch 10 8.6 Mobile kit 10 2

3

1. Gantry 1.1 Mammography stand Measures See Figure 1, next page Weight 260 kg (573.2 lbs.) SID (Source Image Distance) 660 mm (2 2 ) Multi-slit scanning technology Scan-time Scatter rejection 4 16.5 s 97% 1 Movements All movements are motorized Height (from floor to patient support) 760 mm 1380 mm (2 5.9 4 6.3 ) Speed of vertical movement 50 mm/s Rotation -100 to +180, isocentric Speed of rotational motion 10 /second Programmable auto positioning with automatic mirroring of angles. Can be controlled from acquisition workstation Dx CC Sin CC Dx MLO Sin MLO Dx LM Sin LM Control buttons Adjustment of height and angle via buttons located on both sides of the tube head and the breast support table Collision protection Yes Compression Motorized movement controlled with foot pedals Compression force 0 200 N, configurable first stop limit for compression force Maximum distance breast support to paddle 180 mm (7 ) Maximum compression height at exposure High collimator 120 mm (4.7 ) Low collimator 100 mm (3.9 ) Automatic release of compression Automatic release after exposure Release of compression force in case of power loss Release of compression force if the emergency stop is activated Light Positioning light that automatically switches on when foot pedal is activated Display Display of compression force, compression height, and projection angle at the foot of the gantry 4

1195 mm (3 11 ) 760 mm (2 5.9 ) 1657 mm (5 5.2 ) 1380 mm (4 6.3 ) 2212 mm (7 3.1 ) 670 mm (2 2.4 ) -100 +180 626 mm (2 0.6 ) 535 mm (1 9.1 ) Max 1540 mm (5 0.6 ) 602 mm (1 11.7 ) Figure 1 5

2. Detector 2.1 Direct digital detector Detector technology Photon counting with single-shot spectral imaging capability Detector material Crystalline silicon Pixel size 50 µm Field Of View (FOV) 24 x 26 cm (9.4 x 10.2 ) Dynamic range 15 bits Image size (data) 50 Mb (uncompressed) Nyquist frequency 10 lp/mm DQE >0.70 at 1 mm-1 (measured according to the standard IEC 62220-1-2) MTF >0.45 at 4 mm-1 on patient support >0.47 at 4 mm-1 45 mm above patient support 3. Tube and generator 3.1 X-ray tube Maximum tube voltage 40 kvp Maximum power to the anode 6.8 kw (at 38 kvp, 180 ma) Anode material Tungsten Anode rotation speed 10800 RPM Focal spot size 0.3 mm (0.012 ) according to IEC 60336 Filter 0.40 mm (0.016 ) Al Total filtration (including collimator cradle) 0.46 mm (0.018 ) Al equivalent at 30 kvp 3.2 High-voltage generator Power 9 kw kv range 20 40 kvp Maximum mas 4000 mas Ripple Max. 1% 3.3 Exposure control Exposure settings SmartAEC, Automatic or Manual SmartAEC exposure mode continuously adjusts the exposure, during the image scan, according to feedback from the detector 2 6

4. Acquisition workstation 4.1 Acquisition workstation Measures See Figure 2 Acquisition workstation table options Standard table with integrated lead glass Optional height adjustable table for ergonomic working positions Weight of standard acquisition workstation 75 kg (165.35 lbs) table Weight of optional acquisition workstation 75 kg (165 lbs) table Stand alone lead glass: 30 kg (65 lbs) Optional larger radiation protection shield available Protective lead glass 0.5 mm Pb equivalent at 55-120kVp PC Intel Core i5 or better Storage capacity up to 10000 images Operating system: Microsoft Windows 7 Professional Monitor Standard Display: Min 19 (482.6 mm) with 1 Mpx (1280 x 1024) Optional DICOM Displays: Min 19 (482.6 mm) with 1 Mpx (1280 x 1024) Min 21 (533.4 mm) with 3 Mpx (2048 x 1536) Short-cut keypad Yes Exposure Exposure buttons on acquisition workstation table or optional foot pedal Time to display <20 s DICOM Compliance Verification as SCU (Service Class User) Basic Grayscale Print Management Meta as SCU Modality Performed Procedure Step (MPPS) as SCU Digital Mammography Image Storage For Presentation as SCU Digital Mammography Image Storage For Processing as SCU Digital X-Ray Image Storage For Presentation as SCU Digital X-Ray Image Storage For Processing as SCU Modality Worklist as SCU Storage Commitment Push Model SOP Class as SCU 7

Figure 2 8

5. Side cabinet 5.1 Side cabinet containing cooling system and electronics Measures See Figure 3 Weight 100 kg (220 lbs) Figure 3 6. Dose configurations 6.1 Dose levels Breast thickness C100 dose setting C120 dose setting Acceptable level * Achievable level * 3cm (1.18 ) 0,31 0,38 0,55 0,68 <1.2 <0.9 5cm (1.97 ) 0,37 0,45 0,63 0,77 <2.3 <1.8 8cm (3.15 ) 0,83 1,01 1,11 1,29 <5.7 <4.6 Table 1: Measured AGD (mgy) and limiting values from European Guidelines. Confidence intervals are 2 standard deviations. C100 The C100 dose configuration corresponds to a set of target image quality figures that meet the so-called Acceptable limiting values in the European Guidelines 3 C120 This dose configuration corresponds to a set of image quality figures that provide 20% higher SDNR (a.k.a. CNR) than the C100 setting. This is equivalent to being able to see 20% thinner objects of the same size 9

7. Operating conditions 7.1 Electrical requirements Main input connection three-phase Max peak power (max 15 s) Max average power consumption Standby power 190/200/208/220/230/240/380/400/415/440/480 VAC ±10%, 50/60 Hz Additional power stabilizer for 190/200/208/220/230/240/380/400/ 415/440/480 VAC 12.85 kva 2.8 kva 2.5 kva 7.2 Operating environment Temperature Temperature change Humidity Atmospheric pressure +10 C to +30 C 3 C / hour 30% to 75% (non-condensing) 700 hpa to 1060 hpa 7.3 Transport and storage environment Temperature Humidity Atmospheric pressure +5 C to +30 C -10 C to +50 C, less than 1 day 10% to 75% (non-condensing) 95% max, less than 2 weeks 500 hpa to 1060 hpa 7.4 Heat dissipation Gantry and acquisition workstation Side cabinet Cooling air supply 0.7 kw (maximum workflow) 0.4 kw (stand-by mode) 2.5 kw (maximum workflow) 1.5 kw (stand-by mode) Shall comply with specified operating environment 10

8. Accessories 8.1 Compression paddles Compression paddles Standard, Figure 4 High edge, Figure 5 Small, Figure 6 Medium (optional), Figure 7 Spot (optional), Figure 8 Low Spot (optional), Figure 9 Accessory shelf Easy accessible storage for MicroDose compression paddles and calibration phantoms. 8.2 Spectral breast density measurement Spectral Breast Density Measurement tool uses spectral information obtained during the MicroDose SI standard mammogram to differentiate between adipose and fibroglandular tissue to provide objective volumetric breast density measurement 4 Data provided Volumetric percentage of glandular tissue Volume of glandular tissue Total breast volume MicroDose density score (correlated to BI-RADS breast composition score) Output format The calculated breast density data is available in DICOM header and DICOM Structured Report for easy integration with diagnostic workstations 8.3 Diagnostic Scan Diagnostic Scan is a faster, low dose alternative to geometric magnification using spot compression in combination with a focused scan and digital magnification Field of view 24 x 12.6 cm (9.45 x 4.96 ) SDNR doubled compared to C100 dose configuration. 8.4 Needle examination package Philips laser-based needle guidance system facilitates localization of non-palpable lesions with a hook wire solution The Needle examination package consists of: Laser guidance system, Figure 10 A Window compression paddle 8 x 4cm (3.15 x 1.57 ), Figure 11 A Matrix compression paddle 6 x 11cm (2.36 x 4.33 ), Figure 12 Needle examination software 8.5 Four pedals foot switch Foot switch controlling Compression force and Compression done as well as C-arm height. 8.6 Mobile kit Specially designed mobile kit provides a proper and secure installation of MicroDose Mammography on the mobile setting The Mobile Kit/System attachment kit is composed of: Radiation shield mounting kit Main cabinet mounting kit Side cabinet mounting kit AW table mounting kit AW table conversion kit 11

Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 12

References 1. Åslund, M. et al., 2006. Scatter rejection in multislit digital mammography. Medical Physics, 33(4), pp. 933-40. 2. Åslund, M. et al., 2005. AEC for scanning digital mammography based on variation of scan speed. Medical Physics, 32(11), pp. 3367-74. 3. Perry, N. et al., 2006. European Guidelines for quality assurance in breast cancer screening. Luxemburg: Office for Official Publications of the European Communities. 4. Ding H, Molloi S., 2012. Quantification of breast density with spectral mammography based on a scanned multi-slit photon-counting detector: A feasibility study. Phys Med Biol. 57: 4719 4738. Please visit www.philips.com/microdosesi 2013 Koninklijke Philips N.V. All rights are reserved. Philips Healthcare reserves the right to make changes in specifications and/ or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. Philips Healthcare is part of Royal Philips www.philips.com/healthcare healthcare@philips.com Printed in The Netherlands 4522 962 98131 * DEC 2013