Whale Imaging - Product Specification Product Name: MultiScan G-Arm System Product Model: B6 Brand: G-Arm Duo Docref: WIULH030318-9

MultiScan G-Arm System B6 – G-Arm Duo 1. Scope This specification applies to the B6 MultiScan G-Arm System. Reference and applicable regulatory standards Description Directive 93/42 / EEC on medical devices 2011-65-EU ROHS Directive Requirements for medical equipment quality management system Requirements for medical equipment quality management system 21 CFR 892.1650 21 CFR 892.1720 21 CFR 892.1650 Medical electrical equipment - Part 1: General requirements for safety Medical electrical equipment - Part 1: General requirements for safety - Corrigendum 1 Medical electrical equipment - Part 1:...

Product application 3.1 Anticipated Usage Provide orthopedic surgeons real time X-ray orthopedic surgical images, for use in Trauma Surgery, Orthopedics, Spine Surgery and Chest Surgery, etc. 3.2 Anticipated applicable market：North America, Europe 3.3 Anticipated applicable population： general public 4. Risk Analysis 4.1 Implementation of ISO14971: 2007, YY / T0316-2008 standards, using FMEA analysis according to "risk analysis control procedures" 4.2 Complete Risk Analysis report after each development stage. 4.3 Details are documented in the Risk Analysis Report. Manufacturing process 5.1 The...

7.3.2. Image Intensifier Units Image Intensifier type Useful entrance field size Triple Field - Normal - Magn.1 - Magn.2 Output image diameter Resolution Conversion factor Contrast ratio 7.3.3. Image performance Line pair resolution Low-contrast resolution Gradation of image level Distortion rate 7.3.4. Grid Size Lines Ratio F.D. Absorption 7.3.5. TV Chain CCD Cameras Video out Main Monitors Control Monitor 7.3.6. Communication Ports DICOM 3.0 standard OK-AM1566-AOOX , 1024 x 1024 pixels 12 bit 19’’LCD monitors x2, 4:3 flicker-free, high contrast and high brightness Maximum Resolution1280×1024@60Hz,...

Image documentation Horizontal and vertical image Flipping. Digital image rotation (virtual setting). User Interactive Brightness adjustment User Interactive Contrast adjustment Zoom function Annotation Left/Right transpose Up/Down transpose Positive/Negative image Real time sharpen Real time denoise Digital image rotation Cine loop Guide line Printer (optional), DICOM, USB 7.3.8. Software Functions X-ray system Manual Continuous Fluoroscopy kV: min 40, max 120, step: 1kV mA: min 0.2, max 5.0, step: 0.1 mA Automatic Continuous Fluoroscopy kV: min 40, max 120 mA: min 0.2, max 5.0 Manual Pulse...

Mains Connection Mains connection Power Main fuse 7.3.11. Operating Environment Temperature Relative humidity Barometric 7.3.12. Transport and Storage Environment Temperature -20°C-55°C (-4°F-131°F) Relative humidity 10% ~90% Barometric 700hPa~1060hPa 7.3.13. Dimensions SID variable I-I.-unit travel G-arm, bilateral vertical G-arm, rotation G-Arm lat .axial rotation Focal spot to skin distance G-arm height G-arm width G-arm length Control unit height Control unit width Control unit length G-arm weight Control unit weight Main monitor rotation Free Space in Arc Starting force Motor noise Emergency...

Medical electrical equipment - Part 1: General requirements for safety - Collateral standard - General requirements for radiological protection of X-ray equipment Medical electrical equipment - Part 1: Requirements for safety - Common requirements - Electromagnetic compatibility - Requirements and tests Safety of laser products - Part 1: Classification of equipment, requirements X-ray equipment for radiographic and radiological fluoroscopy - Particular requirements for basic safety and essential performance Medical electrical equipment - Part 1: Requirements for safety - Common requirements -...

14. G-Arm System and Console 15. G-Arm System Representative Movements 16. Required Work Space - mm(inch)

18. Control Unit Dimensions (mm) Head Office Whale Imaging Inc 300 2nd Avenue Waltham, MA 02451, USA Phone: +1 781 449 7200 Fax: +1 781 449 7208 Em: [email protected] Europe EU Representative Obelis S.A. Bd. Général Wahis 53, 1030 Brussels, BELGIUM Tel: +32 2 732 5954 Fax: +32 2 732 6003 / 8 9 Manufacturer Beijing East Whale Imaging Technology Co. Ltd Unit 701-708, Building 1, Yongchang Industrial Park
No.3 Yongchang North Rd., BDA, Beijing 10023, China
 Phone: 86 10 678 92 701 www.whaleimaging.com