Related Manuals for Siemens Healthineers SOMATOM
Summary of Contents for Siemens Healthineers SOMATOM
- Page 1 SOMATOM Instructions for Use – Additional Product Information for China X-ray Equipment for Computed Tomography siemens-healthineers.com...
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Page 3: Table Of Contents
9 Restrictions regarding optional accessories 10 List of technical terms 11 SOMATOM Drive - Technical specifications 11.1 Typical CT conditions of operation 11.2 CT number (accuracy of CT values) 11.3 Image Noise SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 4 Table of contents 11.4 Uniformity (homogeneity for CT value) 11.5 Spatial resolution (high-contrast resolution) 11.6 Low-contrast resolution 12 Contact addresses for China 13 Structures and compositions 14 FAST 3D Camera syngo CT 15 Restrictions regarding postprocessing applications Index Additional Product Information for China | Instructions for Use Print No.
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Page 5: Introduction
Compatible systems This information applies to the following CT system: • SOMATOM Drive Applicability This manual is only valid in conjunction with the Instructions for Use of each SOMATOM CT system. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 6 1 Introduction WARNING Not observing the Instructions for Use and the safety information of the medical device and the equipment! Injury to the patient or personnel, and damage to the equipment. ◆ Always observe the Instructions for Use of the particular units used.
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Page 7: Standards And Electromagnetic Compatibility (Emc)
X-ray tube assemblies for medical diagnosis IEC 60601‑2‑44:2016 Medical electrical equipment – Part 2-44: GB 9706.244-2020 Particular requirements for the basic safety and essential perform- ance of X-ray equipment for computed tomography SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... -
Page 8: Electromagnetic Compatibility According To
2 Standards and electromagnetic compatibility (EMC) Standard Title IEC 60601‑1‑2:2007 Medical electrical equipment – Part 1-2: YY 9706.102-2021 General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility requirements and tests Electromagnetic compatibility according to IEC 60601‑1‑2 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. - Page 9 The quality requirement of the main power following a typical transient/burst supply lines supply lines commercial quality or hospital environment. IEC 61000-4-4 ± 1 kV for input/ ± 1 kV for input/ GB/T 17626.4 output lines output lines SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02...
- Page 10 2 Standards and electromagnetic compatibility (EMC) Immunity test IEC 60601 test Compliance level Electromagnetic environment ‑ guidance level Surge ± 1 kV line to line ± 1 kV line to line The quality requirement of the main power following a typical IEC 61000-4-5 commercial quality or hospital environment.
- Page 11 Declaration on electromagnetic immunity is the a.c. mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02...
- Page 12 2 Standards and electromagnetic compatibility (EMC) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a: Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
- Page 13 RF communications equipment (transmitters) and the CT systems as recommended below, according to the maximum output power of the communication equipment. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02...
- Page 14 2 Standards and electromagnetic compatibility (EMC) Other equipment may interfere with the medical equipment, even if the other equipment complies with CISPR emission requirements. Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 15: Nmpa Registration Number And Product Technical Requirement (Ptr) Number
This chapter introduces the NMPA registration number and the PTR number for SOMATOM systems. NMPA registration number This section shows the NMPA registration number for the SOMATOM system. SOMATOM Drive Product Technical Requirement number This section shows the PTR number for the SOMATOM system. - Page 16 NMPA registration number and Product Technical Requirement (PTR) number Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 17: Product Labels For China
IEC60601-1:2005 要求). 请注意，为了保证系统在 此期限内的安全 使用，应遵守本手册中所规定的强制性安全检查及其时间间隔要 求；且适当时应采取预防性 措施或进行维修 The SOMATOM CT systems are specified for an Expected Service Life of 10 years for which the systems are expected to be safe for use (according to IEC 60601-1:2005). Note that the safety checks and their time intervals, as specified in the System Owner Manual, are mandatory. - Page 18 4 Product labels for China Where appropriate, preventive measures have to be adopted or repairs performed to ensure the safety of the system for this time. Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 19: Radiation Label For China
The location of the label is depicted in the schematic representation of the equipment. (1) Warning label: radioactive material or ionizing radiation Warning; Radioactive material or ionizing radiation To warn of radioactive material or ionizing radiation. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 20 5 Radiation label for China Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 21: Rohs Labeling Requirements For China
• Lead (Pb) • Mercury (Hg) • Cadmium (Cd) • Hexavalent chromium (CrVI) • Polybrominated biphenyls (PBB) • Polybrominated diphenyl ethers (PBDE) SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... -
Page 22: Hazardous Substances And Elements
6 RoHS labeling requirements for China Hazardous substances and elements 产品中有害物质的名称及含量 Name and concentration of hazardous substances in the product 部件名称 有害物质 Parts Hazardous substance 铅 汞 镉 六价铬 多溴联苯 多溴二苯醚 Cr (VI) PBDE 机架机械装置 Gantry Mechanic Set 机架盖 Gantry Covers 机架旋转马达... - Page 23 Cabling 电脑 Computer 显示器 Monitor 键盘 PC Keyboard 数字视频接口 病人监控模块 Patient Monitoring Module 机架滑环装置 Gantry Sliding Unit 本表格依据 SJ/T 11364 的规定编制。 This table is created according to SJ/T 11364 standard. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02...
- Page 24 6 RoHS labeling requirements for China • o： 表示该有害物质在该部件所有均质材料中的含量均在 GB/T 26572 规定的限量要求以下 Indicates that the concentration of the hazardous substance in all homogeneous materials in the parts is below the relevant threshold of the GB/T 26572 standard. • x： 表示该有害物质至少在该部件的某一均质材料中的含量超出 GB/T 26572 规定的限量要求。...
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Page 25: Released Bolus Injectors
Bracco (formerly Suisse Medical CT Exprès Care) * The products are not commercially available in all countries. Due to regulatory requirements, their future availability in your country cannot be guaranteed. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 26 7 Released bolus injectors Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 27: Released Respiratory Gating Systems
Released respiratory gating systems 8 Released respiratory gating systems The following respiratory gating systems are released for SOMATOM Drive: Manufacturer Respiratory gating systems ANZAI MEDICAL CO.,LTD AZ-733V ANZAI MEDICAL CO.,LTD AZ-733VI Varian Medical Systems, Inc. RGSC 1.1 Varian Medical Systems, Inc. - Page 28 8 Released respiratory gating systems Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 29: Restrictions Regarding Optional Accessories
Restrictions regarding optional accessories 9 Restrictions regarding optional accessories RTP functionality The RTP functionality, including the RTP table top, will not be available on the Chinese market for SOMATOM Drive. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 30 9 Restrictions regarding optional accessories Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 31: List Of Technical Terms
Rev. (Res.) 分辨率 Type 类型 Software 软件 Part No. 部件号 in VDC VDC 输入 out kW kW 输出 W Power (Leistung) W 功率 V (Voltage) 伏特（电压） Filter 滤过 毫米 钛 SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 32 10 List of technical terms English Chinese PTFL PTFL 铝 Erzeugnisstand (Revision) 生产状况 Product status 产品状况 Subject No. 主题号 Protection Type 保护类型 Cooling Water 冷却水 m³/h 立方米/每小时 Part No. 部件号 Refrigerant 制冷剂 千克 空气 °C 摄氏度 Frequency 频率 cos φ cos φ...
- Page 33 媒介 Factory Set 出厂设置 Customer Set 客户设置 Voltage Range 电压范围 Short Term 短期 Long Term 长期 Siemens Part 西门子部件 max load 最大负荷 N (Newton) N （牛顿） ibs (pound) ibs （磅） SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02...
- Page 34 10 List of technical terms Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 35: Somatom Drive - Technical Specifications
Values and descriptions of this chapter are information according to standard YY 0310. They may be additional information or may replace values listed in the System Owner Manual of the SOMATOM Drive. Typical CT conditions of operation 11.1 Application type... -
Page 36: Ct Number (Accuracy Of Ct Values)
11 SOMATOM Drive - Technical specifications Application type Typical Head Typical Body Typical pediatric Typical pediatric Head Body Reconstructed 10 mm 10 mm 10 mm 10 mm slice width Convolution ker- Hr32 Br32 Hr38 Br38 (Admire Strength (Admire Strength (Admire Strength (Admire Strength 11.2... -
Page 37: Uniformity (Homogeneity For Ct Value)
Modulation Transfer Function (MTF) of the system. For MTF along the z-axis, the MTF is determinded for the slice-sensitivity profile that was obtained in the test of a helical slice width for a 0.6 mm slice. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... -
Page 38: Low-Contrast Resolution
11 SOMATOM Drive - Technical specifications With typical operating conditions of CT for Head and Body, the following values for spatial resolution can be achieved according to the YY 0310 related testing method. In-plane resolution Scan Mode High-contrast resolution Typical Head 3.15 LP/cm ±... - Page 39 A 5 mm diameter round insert at a nominal contrast of 3HU in a diameter 20 cm-CATPhan® phantom can be detected in a 10 mm slice in a Body mode at a CTDIvol (16 cm) ≤ 12 mGy. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02...
- Page 40 11 SOMATOM Drive - Technical specifications Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 41: Contact Addresses For China
地址：中国（上海）自由贸易试验区英伦路 38 号五层 516 室 电话：400-810-5888 售后服务单位 After-sales service organization 名称：西门子医疗系统有限公司 电话：400-810-5888 For the address and contact details of the Legal Manufacturer, refer to the last page of this document. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 42 12 Contact addresses for China Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 43: Structures And Compositions
X-ray tube assembly – Beam limiting device (BLD) – Detector • • Console (ICS, monitor) • Patient table • Power distribution cabinet (PDC) • CT Workplace (option) • Optional accessories and software SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 44 13 Structures and compositions Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 45: Fast 3D Camera
FAST 3D Camera is applicable to the routine examination for adult patient, excluding below: • Pediatric patient • Traumatic patient • Patient whose body is covered (for example, with a blanket) • Patient under RTP scanning SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 46 14 FAST 3D Camera Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 47: Restrictions Regarding Syngo Ct Postprocessing Applications
CT postprocessing applications 15 Restrictions regarding Restrictions regarding syngo CT postprocessing applications The postprocessing application syngo CT Oncology will not be available on the Chinese market with SOMATOM Drive. SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 48 syngo CT postprocessing applications 15 Restrictions regarding Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
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Page 49: Index
17 product technical requirement 15, 15 PTR 15, 15 radiation label 19 registration number 15 registration 15 respiratory gating 27 RoHS labeling 21 hazardous substances and elements 22 SOMATOM | X-ray Equipment for Computed Tomography Print No. C2-047.623.07.08.02... - Page 50 This page has been intentionally left blank. Additional Product Information for China | Instructions for Use Print No. C2-047.623.07.08.02...
- Page 52 Council Directive 2011/65/EU of June 08, 2011 on the restriction of the use of certain hazardous The original language of this document is English. substances in electrical and electronic equipment. Siemens Healthineers Legal Manufacturer Headquarters Siemens Healthcare GmbH Siemens Healthcare GmbH Henkestr.
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