O-ARM IMAGING SYSTEM TECHNICAL SPECIFICATION GUIDE

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IMAGING SYSTEM TECHNICAL SPECIFICATION GUIDE

SYSTEM FEATURES CATEGORY PHYSICAL DIMENSIONS IMAGING MODALITY PERFORMANCE SPECIFICATION Length Width Height Weight Gantry Opening Bore Diameter Single Plane 2D Multi Plane 2D Standard 3D Volumetric 110.5 in (280.6 cm) *docked 32.0 in (81.3 cm) 79.6 in (202.2 cm) *gantry door open 2046 lbs (925.8 Kg) 27.5 in (69.9 cm) 38 in (96.5 cm) Pulsed fluoroscopy at 30 frames/second Up to four 2D images, from pre-set positions Data Acquisition: < 16 seconds -Standard: 14seconds Number of Projections: 391 images over 360º 3D Reconstruction Time: -Standard: 7seconds Field of View (FOV) option: 20cm Resolution (mm): 0.415 x 0.415 x 0.833 Reconstructed Matrix Size: 512 x 512 x 192

SYSTEM FEATURES CATEGORY IMAGING MODALITY PERFORMANCE SPECIFICATION High Definition 3D Volumetric Low Dose 3D Volumetric Data Acquisition: < 30seconds -Standard: 27seconds Number of Projections: 745 images over 360º 3D Reconstruction Time: -Standard for 20cm FOV: 23seconds -Standard for 40cm FOV: 23seconds Field of View (FOV) options: 20cm 40cm Resolution (mm): 20cm FOV: 0.415 x 0.415 x 0.833 40cm FOV: 0.775 x 0.775 x 0.833 Reconstructed Matrix Size: 512 x 512 x 192 Data Acquisition: < 16 seconds -Standard: 14seconds Number of Projections: 391 images over 360º 3D Reconstruction Time: < 90 seconds -Standard: 65seconds Field of View option: 20cm Resolution (mm): 0.415 x 0.415 x 0.833 Reconstructed Matrix Size: 512 x 512 x 192

SYSTEM FEATURES CATEGORY SPECIFICATION IMAGING MODALITY PERFORMANCE Enhanced Cranial 3D Volumetric Stereotaxy 3D Volumetric Data Acquisition: -Standard: 27seconds Number of Projections: 745 images over 360º 3D Reconstruction Time: -Standard: 13seconds Field of View (FOV) option: 20cm Resolution (mm): 0.415 x 0.415 x 0.833 Reconstructed Matrix Size: 512 x 512 x 192 Data Acquisition: -Standard: 27seconds Number of Projections: 745 images over 360º 3D Reconstruction Time: -Standard: 13seconds Field of View (FOV) option: 40 cm Resolution (mm): 0.775 x 0.775 x 0.833 Reconstructed Matrix Size: 512 x 512 x 192

SYSTEM FEATURES CATEGORY SPECIFICATION 3D IMAGING VOLUME Cylindrical Volume Resolution 20 cm FOV: 21.25 cm diameter x 15 cm high 40 cm FOV: 39.70 cm diameter x 15 cm high 20 cm FOV (mm): 512 x 512 x 192 2D IMAGE ENHANCEMENTS X-RAY TUBE Edge enhancement Recursive noise reduction Auto-brightness control Auto window/level Region of Interest Full field of regional dose control 40 cm FOV (mm): 512 x 512 x 192 7 settings Automatic Yes Yes User Selectable Yes Varian Model B100 (rotating anode) with A132 insert; generator is max rated at 32KW X-RAY DETECTOR Varian Model Paxscan 4030D 2.0K x 1.5K, pixel pitch of 0.194mm amorphous silicon COLLIMATION COLLIMATION X-Y axis shutters POWER- ASSISTED TRANSPORT Electronically controlled by user Dynamically adjustable filter set 3D collimation also available 1.5 max MPH power drive system Independent rear wheel drive Handle-controlled

SYSTEM FEATURES CATEGORY SPECIFICATION ROBOTIC MOTION CONTROLS (movement speeds) Linear gantry motion Rotational Wag Rotational Tilt X and Y-axis: 5 inches/second Z-axis: 2.5 inches/second 4º per second 7.5º per second Gantry Door (open/close) 8º per second Gantry rotor (internal) 60º per second (max.) Note: Gantry linear movement speed can be slowed ten-fold by pressing the [M] button on the pendant. ROBOTIC MOTION CONTROLS (movement ranges from docked position) Linear gantry, Vertical: ±9 inches (±0.125 inches), ±22.9 (±0.32 cm) 17.25 inches total *Y-axis gas springs account for decrease of 0.75 inches Linear gantry, Transverse: ±9 inches, ±22.9cm 18 inches total (45.8cm) Linear gantry, Longitudinal: ±7 inches (±0.25in), ±17.8 (±0.64 cm) 14 inches total Rotational Wag ±15º Rotational Iso-wag ±12º (nominal) Rotational Tilt ±45º

ENVIRONMENTAL & POWER SPECS ENVIRONMENTAL SPECIFICATIONS OPERATING OPERATING Temperature 10 30 C STORAGE AND TRANSPORTATION Humidity Vibration: Frequency g value Amplitude Shock: g value pulse Duration Temperature Humidity 0-80% RH Non-condensing No open vibration No open shock -10 to 40 C 10-80% RH Non-condensing Vibration: Frequency 0.01 g-squared/hz @ 4 100 Hz tapered to 0.001 squared/hz @ 200 Hz POWER REQUIREMENTS VAC 100 to 240 VA FREQUENCY 50/60 Hz POWER REQUIREMENTS 1440 VA

X-RAY SPECIFICATIONS X-RAY SOURCE ASSEMBLY TUBE TYPE HOUSING TYPE TUBE RATING FOCAL SPOT Varian A132 (rotating anode) B100 150 kv Dual: The nominal focal spot values according IEC 60336 are: For small focal spot: Width = 0.60 mm to 0.90 mm Length = 0.90 mm to 1.30 mm INHERENT FILTRATION ADDED FILTRATION LEAKAGE TECHNIQUE FACTORS ANODE HEAT STORAGE CAPACITY HOUSING HEAT STORAGE CAPACITY For large focal spot: Width = 1.20 mm to 1.70 mm Length = 1.7 mm to 2.4 mm 0.7mm Al Additional filtration was added to beam for a total: > 4mm Al 150kV, 3.3mA 300kHU (222 kj) 1,250kHU (927 kj)

X-RAY SPECIFICATIONS X-RAY GENERATOR ASSEMBLY GENERATOR RANGE Power 32 KW Max - ACCURACY kvp Reproducibility - <= 0.05 CV mas Linearity - <0.05 Adjacent <0.1 Non-adjacent PULSED EXPOSURE MODE kvp 40-140 kvp (in 1 kvp Steps) ±10% ma 10, 12.5, 16, 20, 25, 32, 40, 50, 63, 80, 100 ± 20% Exposure Time Per Pulse 10 msec ±10% + 1 msec PULSED FLUORO MODE kvp 40 125kVp (in 1kVp steps) ± 10% ma Reported Value ± 20% Exposure Timer Per Pulse 10 msec ± (10% + 1msec)

Medtronic Neurosurgery 826 Coal Creek Circle Louisville, CO 80027 USA Internet: www.medtronicneurosurgery.com Toll-free: (888) 580-8860 Telephone: +(720) 890-3200 Fax: +(720) 890-3500 * Patent Numbers 6,940,941; 7,108,421; 7,001,045; 7,106,825, other Patents Pending. 2015 Medtronic Inc. All Rights Reserved. UC201602922 EN 09.2015 Rx only.