1．Could you list the names of some medical device？ 1.您能列出一些医疗器械的名称吗？
2．Have you heard of GHTF？What kind of an organization is GHTF？ 2.您听说过 GHTF 吗？GHTF 是一个什么样的组织？
GHTF 全联盟
The Global Harmonization Task Force 全球协调工作组 （GHTF）was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems． （GHTF） 构思于 1992 年，旨在实现国家医疗器械监管体系之间的更大统一。
GHTF was a voluntary group of representatives from national medical device regulatory authorities and the regulated industry．The GHTF was comprised of representatives from five founding members grouped into three geographical areas：Europe，Asia－Pacific and North America，each of which actively regulates medical devices using their own unique regulatory framework．Beginning in 2006， membership expanded to include three Liaison Body members：Asian Harmonization Working Party（AHWP），International Organization for Standardization（ISO），and International Electrotechnical Commission（IEC）． 全球医疗器械工作组是一个由来自国家医疗器械监管机构和受监管行业的代表组成的自愿小组。全球联合特遣部队由来自五个创始成员的代表组成，这些成员分为三个地理区域：欧洲、亚太和北美，每个地区都使用自己独特的监管框架积极监管医疗器械。从 2006 年开始，成员扩大到包括三个联络机构成员：亚洲协调工作组 （AHWP），国际标准化组织 （ISO） 和国际电工委员会 （IEC）。
The purpose of the GHTF was to encourage convergence in regulatory practices related to ensuring the safety，effectiveness／performance and quality of medical devices，promoting technological innovation and facilitating international trade．The primary way in which this purpose was accomplished was via the publication and dissemination of harmonized documents on basic regulatory practices．These documents，which were developed by five different GHTF Study Groups，provided a model for the regulation of medical devices that can then be adopted／ implemented by national regulatory authorities． GHTF 的目的是鼓励与确保医疗器械的安全性、有效性/性能和质量相关的监管实践趋同，促进技术创新和促进国际贸易。实现这一目的的主要方式是通过发布和传播有关基本监管实践的协调文件。这些文件由五个不同的 GHTF 研究组制定，为监管然后，国家监管机构可以采用/实施的医疗器械。
The organization GHTF no longer exists，and has been permanently replaced by the IMDRF． The International Medical Device Regulators Forum（IMDRF）is continuing the work of GHTF． GHTF 组织已不复存在，并已被 IMDRF 永久取代。国际医疗器械监管机构论坛 （IMDRF） 正在继续 GHTF 的工作。
Vocabulary Help 词汇帮助
Global Harmonization Task Force 全球协调工作组
全球协调工作组
liaison［lieiz（e）n］ 联络人[lieiz（e）n]
n．联络
Asian Harmonization Working Party 亚洲协调工作组
亚洲协调工作组
International Organization for Standardization 国际标准化组织
International Medical Device Regulators Forum 国际医疗器械监管机构论坛
国际医疗器械监管者论坛
Global Harmonization Task Force 全球协调工作组
liaison［lieiz（e）n］ n．联络
Asian Harmonization Working Party 亚洲协调工作组
International Organization for Standardization 国际标准化组织
International Electrotechnical Commission 国际电工委员会
convergence［ken＇ve：dzans］ n.
dissemination［di：semi＇neifn］ n.
International Medical Device Regulators Forum 国际医疗器械监管者论坛| Global Harmonization Task Force | 全球协调工作组 |
| :--- | :--- |
| liaison［lieiz（e）n］ | n．联络 |
| Asian Harmonization Working Party | 亚洲协调工作组 |
| International Organization for Standardization | 国际标准化组织 |
| International Electrotechnical Commission | 国际电工委员会 |
| convergence［ken＇ve：dzans］ | $n$. |
| dissemination［di：semi＇neifn］ | $n$. |
| International Medical Device Regulators Forum | 国际医疗器械监管者论坛 |
T®TG T®TG 系列
Medical Device Definition 医疗器械定义
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro－chip technology and laser surgical devices．In addition， medical devices include in vitro diagnostic products，such as general purpose lab equipment， reagents，and test kits，which may include monoclonal antibody technology．Certain electronic radiation emitting products with medical application and claims meet the definition of medical device．Examples include diagnostic ultrasound products，X－rays machines and medical lasers． 医疗器械的范围从简单的压舌板和便盆到具有微芯片技术和激光手术 devices.In 的复杂可编程起搏器，医疗器械包括体外诊断产品，例如通用实验室设备、试剂和检测试剂盒，其中可能包括单克隆抗体技术。X 光机和医用激光器。
This definition provides a clear distinction between a medical device and other products such as drugs or biological products．Medical devices differ from drugs in that they do not achieve their intended use through chemical reaction and are not metabolized in the body． If the primary intended use of the product is achieved through chemical action or by being metabolized by the body，the product is usually a drug．Biological products include blood and blood products． 该定义明确区分了医疗器械和其他产品，如药物或生物制品。医疗器械与药物的不同之处在于，它们不能通过化学反应达到其预期用途，也不会在体内代谢。如果产品的主要预期用途是通过化学作用或被身体代谢实现的，则该产品通常是一种药物。生物制品包括血液和血液制品。
A clear understanding of the medical device definition helps us to determine whether or not a product is a medical device． 清楚地了解医疗器械定义有助于我们确定商品是否为医疗器械。
2．Certain electronic radiation emitting products with medical application and claims meet the definition of medical device． 2.某些具有医疗应用和声明的电子辐射发射产品符合医疗器械的定义。
某些应用于医学及声称具有医学效用的电子辐射发射产品也符合医疗器械的定义范围。
Proctionl dhillb
I．In pairs or small groups，discuss the questions． I.In 两人或小组，讨论问题。
1 ．What is medical device？ 1 .什么是医疗器械？
2．Go to the website www．imdrf．org，and review the GHTF document providing the medical device definition． 2.访问网站 www.imdrf.org，并查看提供医疗器械定义的 GHTF 文件。
3．Visit the website www．fda．gov，and search for the medical device definition regulated by FDA． 3.访问网站 www.fda.gov，并搜索 FDA 监管的医疗器械定义。
4．What is the major distinction between a medical device and drug？ 4.医疗器械和药品的主要区别是什么？
II. Choose the right answer. II. 选择正确的答案。
What kind of an organization is GHTF? GHTF 是一个什么样的组织？
A. It is an organization responsible for the regulation of medical device in USA 一个。它是一个负责美国医疗器械监管的组织
B. It is engaged in the scientific research of medical device B.它从事医疗器械的科学研究
C. Its purpose is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices C. 其目的是鼓励与确保医疗器械的安全性、有效性/性能和质量相关的监管实践趋同
D. It is an official organization of representatives from national medical device regulatory authorities and the regulated industry D. 它是由国家医疗器械监管机构和受监管行业的代表组成的官方组织
Which of the following statement is not true about GHTF? 以下关于 GHTF 的陈述中哪一项是不正确的？
A. It includes three Liaison Body members: The International Medical Device Regulators Forum (IMDRF), International Organization for Standardization (ISO), and International Electrotechnical Commission (IEC) 一个。它包括三个联络机构成员：国际医疗器械监管机构论坛 （IMDRF）、国际标准化组织 （ISO） 和国际电工委员会 （IEC）
B. It works on the publication and dissemination of harmonized documents on basic regulatory practices to provide a model that can then be adopted/implemented by national regulatory authorities B.它致力于发布和传播有关基本监管实践的协调文件，以提供一种模式，然后由国家监管机构采用/实施
C. It has been permanently replaced by the International Medical Device Regulators Forum (IMDRF) C. 它已被国际医疗器械监管机构论坛 （IMDRF） 永久取代
D. It was established by 5 five founding members in 1992 D. 它由 5 名创始成员于 1992 年创立
Medical devices differ from qquad\qquad in that they do not achieve their intended use through chemical reaction and are not metabolized in the body. 医疗器械的不同 qquad\qquad 之处在于，它们不能通过化学反应达到预期用途，也不会在体内代谢。
A. biological products A. 生物制品
B. drugs B. 药物
C. blood products C. 血液制品
D. electronic radiation emitting products D. 电子辐射发射产品
If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a qquad\qquad . 如果产品的主要预期用途是通过化学作用或被人体代谢实现的，则该产品通常是 qquad\qquad .
A. medical device A. 医疗器械
B. biological product B. 生物制品
C. chemical product C. 化工产品
D. drug D. 药物
Blood and blood products are qquad\qquad . 血液和血液制品是 qquad\qquad 。
A. biological product A. 生物制品
B. medical device B. 医疗器械
C. chemical product C. 化工产品
D. pharmaceutic product D. 药剂产品
Which of the following statement is true about medical device? 以下关于医疗器械的陈述中哪一项是正确的？
A. Medical device is used for human beings and animals A. 用于人类和动物的医疗器械
B．Examples of medical devices include diagnostic ultrasound products，X－rays machines and some biological products B.医疗器械的例子包括超声诊断产品、X 光机和一些生物制品
C．Medical device does not achieve its primary intended use through chemical reaction C.医疗器械不能通过化学反应达到其主要预期用途
D．Medical devices include in vitro diagnostic products and life support equipment，but do not include electronic radiation emitting products D.医疗器械包括体外诊断产品和生命支持设备，但不包括电子辐射发射产品
7．Which of the following is not a medical device？ 7.以下哪项不是医疗器械？
A．B－mode ultrasonic instrument A.B 型超声仪器
B．blood glucose monitor B.血糖监测仪
C．reagent C.试剂
D．flu vaccine D.flu 疫苗
8. qquad\qquad are used by qualified health professionals to support life in critically－ill people，in surgical settings or to improve quality of life． 8. qquad\qquad 由合格的卫生专业人员用于支持危重病人的生活、在手术环境中或提高生活质量。
A．Surgery and life support devices A.手术和生命支持设备
B．In vitro diagnostic devices B.In 体外诊断设备
C．Cardiovascular devices C.心血管器械
D．Pediatric medical devices D.儿科医疗器械
9. qquad\qquad devices are used to diagnose and treat heart disease and related health problems． 9. qquad\qquad 设备用于诊断和治疗心脏病和相关健康问题。
A．Surgery and life support devices A.手术和生命支持设备
B．In vitro diagnostic devices B.In 体外诊断设备
C．Cardiovascular devices C.心血管器械
D．Pediatric medical devices D.儿科医疗器械
10. qquad\qquad are tests that can detect diseases，conditions，or infections．Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home． 10. qquad\qquad 是可以检测疾病、病症或感染的测试。一些测试用于实验室或其他健康专业环境，其他测试供消费者在家中使用。
A．Surgery and life support devices A.手术和生命支持设备
B．In vitro diagnostic devices B.In 体外诊断设备
C．Cardiovascular devices C.心血管器械
D．Pediatric medical devices D.儿科医疗器械
III．In pairs，discuss and write definitions for the following terms from the text．You might use the internet to help you． III.In 成对，讨论并写下文本中以下术语的定义。您可以使用互联网来帮助您。
1．Global Harmonization Task Force 1.全球协调工作组
2．International Organization for Standardization 2.国际标准化组织
3．International Electrotechnical Commission 3.国际电工委员会
4．Medical device 4.医疗器械
IV．Translate the following sentences into Chinese． IV.将以下句子翻译成中文。
1．Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro－chip technology and laser surgical devices． 1.医疗设备的范围从简单的压舌板和便盆到采用微芯片技术的复杂可编程起搏器和激光手术设备。
2. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. 2. 此外，医疗器械还包括体外诊断产品，例如通用实验室设备、试剂和检测试剂盒，其中可能包括单克隆抗体技术。
3. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. 3. 如果产品的主要预期用途是通过化学作用或被身体代谢实现的，则该产品通常是一种药物。
V. Read the text and complete the tasks. V. 阅读文本并完成任务。
Read and complete the text using the words below. 使用以下单词阅读并完成文本。
Scientific research requires substantial funding, especially when it involves the use of expensive equipment. This funding often comes directly from qquad\qquad (1) . In the U.S., for example, it is the federal government that sponsors most national defense and space exploration project. 科学研究需要大量资金，尤其是当它涉及使用昂贵的设备时。这笔资金通常直接来自 qquad\qquad （1） 。例如，在美国，联邦政府赞助了大多数国防和太空探索项目。
Funding for science can also come from science qquad\qquad (2) . In 1950, the U.S. congress passed an act that established the National Science Foundation. This independent federal agency develops a national science policy and supports scientific research and education. Two other well-known foundations that are involved in disease research are the American Cancer Society and the National Heart Association. 科学资金也可以来自科学 qquad\qquad （2） 。1950 年，美国国会通过了一项法案，成立了美国国家科学基金会 （National Science Foundation）。这个独立的联邦机构制定国家科学政策并支持科学研究和教育。另外两个参与疾病研究的知名基金会是美国癌症协会和美国国家心脏协会。
Research is also conducted and supported by private-sector qquad\qquad (3) that employ scientists-especially from the applied sciences-who work in the development of industrial or commercial processes and products. 私营部门 qquad\qquad （3） 也开展和支持研究，这些部门雇用从事工业或商业流程和产品开发的科学家，尤其是来自应用科学的科学家。
Scientific research is also supported by qquad\qquad (4) through professorships. Most professors do not just give classes but also conduct scientific research. Indeed, what many professors are looking for is the opportunity to work at a university where they can continue their own research. These are the professors whose students have the chance to observe real research at first hand. Most universities specialize in certain fields and they are frequently judged on the achievements of their research professors. Scientists whose research findings are published and talked about in scientific circles bring prestige to the institution where they work. 科学研究也得到 qquad\qquad （4） 教授职位的支持。大多数教授不仅上课，还进行科学研究。事实上，许多教授正在寻找的是有机会在大学工作，在那里他们可以继续自己的研究。这些教授的学生有机会亲身观察真正的研究。大多数大学都专注于某些领域，他们经常根据其研究教授的成就进行评判。研究成果在科学界发表和谈论的科学家为他们工作的机构带来了声望。
2．Complete these sentences with information that reflects your personal views． 2.用反映您个人观点的信息完成这些句子。
（1）In this country it is qquad\qquad that provides most of the money for scientific research． （1）在这个国家，它 qquad\qquad 为科学研究提供了大部分资金。
（2）In my opinion，what science students are looking for is qquad\qquad ． （2）在我看来，理科学生正在寻找的是 qquad\qquad .
（3）In my opinion， qquad\qquad is the scientist whose work has had the greatest impact． （3）在我看来， qquad\qquad 是其工作影响最大的科学家。
（4）The institutions where many scientists want to work are qquad\qquad ． （4）很多科学家想工作的机构是 qquad\qquad 。
Section 2 Medical Device Classification 第二节 医疗器械分类
Toロケ月⿴囗 Toロケ月忴囗
1．Have you heard of FDA？What kind of organization is FDA？ 1.您听说过 FDA 吗？FDA 是什么样的组织？
2．Go to the website www．fda．gov and locate more information about the organization of FDA． Then prepare a PPT presentation to introduce FDA to your classmates． 2.www.fda.gov 访问网站并找到有关 FDA 组织的更多信息。然后准备一个 PPT 演示文稿，向您的同学介绍 FDA。
FDA 美国食品药品监督管理局
Located within the Department of Health and Human Services，the Food and Drug Administration（FDA）regulates a wide range of medical and food products．From reviewing new medicines to inspecting food processing centers，the FDA plays a role in approximately $1\$ 1 trillion worth of products each year． 美国食品药品监督管理局 （FDA） 位于卫生与公众服务部 （Department of Health and Human Services） 内，负责监管各种医疗和食品产品。从审查新药到检查食品加工中心，FDA 每年在大约 $1\$ 1 数万亿的产品中发挥作用。
The FDA is comprised of chemists，pharmacologists，physicians，microbiologists， veterinarians，pharmacists，lawyers and other professionals．Despite all of the expertise employed by the agency，the FDA has struggled to carry out its mission to protect Americans from harmful drugs and foods．In recent years，the agency＇s reputation has plummeted amid controversies involving the approval of certain pharmaceutical drugs and allowing tainted foods to reach consumers．The Food and Drug Administration（FDA）is a scientific，regulatory and public health agency that oversees the manufacture，import，transport，storage and sale of approximately $1\$ 1 trillion worth of products annually．These products include human and animal drugs，therapeutic agents of biological origin，medical devices，radiation－emitting products for consumer，medical，and occupational use，cosmetics and animal feed．The agency grew from a single chemist in the U．S．Department of Agriculture in 1862 to a staff of approximately 9,100 employees． FDA 由化学家、药理学家、医生、微生物学家、兽医、药剂师、律师和其他专业人士组成。尽管该机构使用了所有专业知识，但 FDA 一直在努力履行其保护美国人免受有害药物侵害的使命，foods.In 近年来，该机构的声誉在涉及批准某些药物和允许受污染食品到达消费者手中的争议中直线下降。美国食品药品监督管理局 （FDA） 是一个每年监督价值约 $1\$ 1 数万亿的产品的制造、进口、运输、储存和销售的科学、监管和公共卫生机构。这些产品包括人类和动物药物、生物来源的治疗剂、医疗器械、消费者、医疗和职业用途的辐射产品、化妆品和动物饲料。该机构从 1862 年美国农业部的一名化学家发展到拥有约 9,100 名员工员工。
About one－third of the agency＇s employees are stationed outside of Washington，DC， 该机构大约三分之一的员工驻扎在华盛顿特区以外，
staffing more than 150 field offices and laboratories，including five regional offices and 20 district offices． 拥有 150 多个外地办事处和实验室，包括 5 个地区办事处和 20 个地区办事处。
Investigators and inspectors visit more than 16，000 facilities a year and arrange with state governments to help increase the number of facilities checked． 调查员和检查员每年访问超过 16,000 个设施，并与州政府安排帮助增加检查的设施数量。
The Food and Drug Administration spent a little more than $2\$ 2 billion from 2000 to 2008 on 7,115 contractors．The largest expenditures were for computer and telecommunications equipment and services，which totaled $436\$ 436 million．Not surprisingly，the top 10 recipients of FDA contracts included computer giants Hewlett－Packard and Oracle． 从 2000 年到 2008 年，美国食品药品监督管理局在 7,115 家承包商身上花费了十亿多 $2\$ 2 一点。最大的支出是计算机和电信设备及服务，总计数百万 $436\$ 436 美元。毫不奇怪，FDA 合同的前 10 名接受者包括计算机巨头惠普和甲骨文。
The USFDA will have a considerable increase in both responsibilities and resources in the coming years． 未来几年，美国食品药品监督管理局 （USFDA） 的职责和资源将大幅增加。
Vocabulary Help 词汇帮助
Food and Drug Administration（FDA） 美国食品药品监督管理局 （FDA）
The U．S．medical device industry is a highly regulated sector of the economy，and the U．S． regulatory systems have significant implications for the industry＇s performance worldwide． Accordingly，the U．S．medical device industry devotes considerable resources toward product approval processes，clinical trials，user fees and plant audits／inspections． 美国医疗器械行业是一个受到高度监管的经济部门，美国的监管体系对该行业的全球表现具有重大影响。因此，美国医疗器械行业在产品审批流程、临床试验、用户费用和工厂审计/检查方面投入了大量资源。
The U.S. Food and Drug Administration governs the regulatory oversight of medical devices. To, ensure the safety, effectiveness/performance and quality of medical devices, medical devices are usually designed and manufactured with rigorous safety standards. 美国食品药品监督管理局 （U.S. Food and Drug Administration） 负责管理医疗器械的监管。为了确保医疗器械的安全性、有效性/性能和质量，医疗器械通常按照严格的安全标准设计和制造。
The regulatory authorities recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused. 监管机构根据其设计复杂性、使用特性以及误用可能造成的危害来识别不同类别的医疗器械。
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices. The USFDA maintains three risk categories that determine the type and depth of review necessary for the marketing of medical devices. According to the standards of the U.S. Food and Drug Administration, a medical device (MD) may be classified as Class I, Class II, and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. Each of these approximately 1,700 different generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. Medical device classification is basically risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk. 美国食品药品监督管理局 （FDA） 已经为大约 1,700 种不同的仿制药类型的器械建立了分类。USFDA 维护三个风险类别，这些类别决定了医疗器械营销所需的审查类型和深度。根据美国食品药品监督管理局 （FDA） 的标准，医疗器械 （MD） 可分为 I 类、II 类和 III 类，其中 III 类涵盖风险最高的产品。分类越高，所需的评估级别就越高。这大约 1,700 种不同的通用类型器械中的每一种都根据确保器械安全性和有效性所需的控制水平被分配到三个监管类别之一。医疗器械分类基本上是基于风险的，也就是说，器械对患者和/或用户构成的风险是其所分配类别的主要因素。I 类包括风险最低的设备，III 类包括风险最大的设备。
Class I devices present the lowest potential risk, and are subject to the least regulatory control. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Class III is the most stringent regulatory category for medical devices. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices that currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants. Most medical devices are considered Class II devices. Devices in class II are typically non-invasive and include X-rays machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles. I 类器械的潜在风险最低，并且受到的监管控制最少。此类设备包括压舌板、便盆、弹性绷带、检查手套、手持式手术器械和其他类似类型的常用设备。III 类是医疗器械最严格的监管类别。III 类器械通常是那些支持或维持人类生命的器械，对防止损害人类健康具有重大意义，或存在潜在的、不合理的疾病或伤害风险的器械。目前需要上市前通知的 III 类器械包括植入式起搏器、脉冲发生器、HIV 诊断测试、自动体外除颤器和骨内植入物。大多数医疗器械被视为 II 类器械。II 类设备通常是无创的，包括 X 光机、PACS、电动轮椅、输液泵、手术单、手术针和缝合材料以及针灸针。
Class I Device I 类设备
Class II Device II 类设备
Class III Device III 类设备
It is usually the Intended Purpose for Use that determines the class of the medical device and not the particular technical characteristics of the device． 通常，决定医疗器械类别而不是器械的特定技术特性的是预期使用目的。
It is the Intended Purpose for Use，assigned by the manufacturer to the device，that determines the class of the medical device and not the class assigned to other similar products manufactured by the same manufacturer or different manufacturers．For instance，two sutures that have the same composition may well have different Intended Purpose． 制造商分配给器械的预期使用目的决定了医疗器械的类别，而不是分配给同一制造商或不同制造商生产的其他类似产品的类别。
Device classification depends on the intended use of the device and also upon indications for use．For example，a scalpel＇s intended use is to cut tissue．A subset of intended use arises when a more specialized indication is added in the device＇s labeling such as，＂for making incisions in the cornea＂．Indications for use shall be found in the device＇s labeling． 设备分类取决于设备的预期用途以及使用适应症。例如，手术刀的预期用途是切割组织。当设备标签中添加了更专业的指示（如“用于在角膜上切开”）时，就会出现预期用途的子集。使用指示应在设备的标签中找到。
The class to which a device is assigned determines，among other things，the type of premarketing submission／application required for FDA clearance to market． 器械被分配到的类别决定了 FDA 批准上市所需的上市前提交/申请类型等。
How to Determine Classification 如何确定分类
To find the classification of your device，as well as whether any exemptions may exist，you need to find the regulation number that is the classification regulation for your device．There are two methods for accomplishing this：go directly to the FDA classification database and search for a part of the device name，or，if you know the device panel（medical specialty）to which your device belongs，go directly to the listing for that panel and identify your device and the corresponding regulation． 要查找器械的分类，以及是否存在任何豁免，您需要找到法规编号，即器械的分类法规。有两种方法可以完成此作：直接转到 FDA 分类数据库并搜索器械名称的一部分，或者，如果您知道器械所属的器械面板（医疗专业），则直接转到该面板的列表并识别您的器械和相应的法规。
1．The regulatory authorities recognize different classes of medical devices，based on their design complexity，their use characteristics，and their potential for harm if misused． 1.监管机构根据医疗器械的设计复杂性、使用特性以及误用可能造成的危害来识别不同类别的医疗器械。
监管当局根据器械设计的复杂性，使用特征以及误用后可能产生的潜在危害，将医疗器械分成不同的类别。
2．Medical device classification is basically risk based，that is，the risk the device poses to the patient and／or the user is a major factor in the class it is assigned． 2.医疗器械分类基本上是基于风险的，也就是说，器械对患者和/或用户构成的风险是其被分配类别的主要因素。
医疗器械分类是基于风险的，也就是说，器械对患者以及（或者）器械使用者可能造成的风险是影响器械分类的重要因素。
3．It is the Intended Purpose for Use，assigned by the manufacturer to the device，that determines the class of the medical device and not the class assigned to other similar products manufactured by the same manufacturer or different manufacturers． 3.It 是制造商分配给器械的预期使用目的，它决定了医疗器械的类别，而不是分配给同一制造商或不同制造商生产的其他类似产品的类别。
生产商所指定的预期用途决定了该医疗器械被划为其所在类别而非同一生产商或不同生产商所生产的其他类似产品所在的类别。
4．A subset of intended use arises when a more specialized indication is added in the device＇s labeling such as，＂for making incisions in the cornea＂． 4.当在设备的标签中添加更专业的指示时，例如“用于在角膜上做切口”，就会出现预期用途的子集。
如果器械的标签上加上了更加专业的指示＂用于角膜的切割＂，就增加了一个类别的预期用途。
PaOcRionl drill b PaOcRionl 钻头 b
I．In pairs or small groups，discuss the questions． I.In 两人或小组，讨论问题。
1．In your country，which government department has responsibility for regulation of medical device？ 1.In 您所在的国家，哪个政府部门负责医疗器械的监管？
2．According to FDA，how many risk categories are medical devices assigned to？Which class of device presents the highest potential for harm to the users？ 2.根据 FDA 的规定，医疗器械被归入多少个风险类别？哪类器械对用户造成伤害的可能性最高？
3．What are the factors affecting the classification of a medical device？ 3.影响医疗器械分类的因素有哪些？
II．Choose the right answer． II.选择正确的答案。
1．Which of the following statement is not true about FDA？ 1.以下关于 FDA 的陈述中哪一项是不正确的？
A．FDA is located within the department of Health and Human Services A.FDA 位于卫生与公众服务部
B．FDA regulates a wide range of medical and food products in the U．S．market B.FDA 监管美国市场上的各种医疗和食品
C. FDA will experience a decrease in its responsibilities and rescources amid controversies involving the approval of certain pharmaceutical drugs and allowing tainted foods to reach consumers C. 在涉及批准某些药物和允许受污染食品到达消费者手中的争议中，FDA 的责任和范围将减少
D. FDA is a scientific, regulatory and public health agency D. FDA 是一个科学、监管和公共卫生机构
2. Which of the following is not under the jurisdiction of FDA? 2. 以下哪项不在 FDA 的管辖范围内？
A. human and animal drugs A. 人类和动物药物
B. medical device B. 医疗器械
C. cosmetics C. 化妆品
D. meat and poultry D. 肉类和家禽
3. How many risk categories are medical device assigned to in USA? 3. 在美国，医疗器械分为多少个风险类别？
A. One 一个。一
B. Two B.二
C. Three C. 三
D. Four D. 四
4. What governs the regulatory oversight of medical devices in USA? 4. 美国医疗器械的监管由什么管理？
A. The Food and Drug Administration 一个。美国食品药品监督管理局 （Food and Drug Administration）
B. The Department of Health and Human Services B.卫生与公众服务部
C. Global Harmonization Task Force C. 全球协调工作组
D. International Electrotechnical Commission D. 国际电工委员会
5. Which class includes devices with the lowest risk? 5. 哪个类别包括风险最低的设备？
A. Class I A. I 类
B. Class II B. II 类
C. Class III C. III 类
D. Class IV D. IV 类
6. Which class includes devices with the greatest risk? 6. 哪个类别包括风险最大的设备？
A. Class I A. I 类
B. Class II B. II 类
C. Class III C. III 类
D. Class IV D. IV 类
7. It is qquad\qquad , assigned by the manufacturer to the device, that determines the class of the medical device. 7. 由 qquad\qquad 制造商分配给设备，决定了医疗器械的类别。
A. the Intended Purpose for Use A. 预期使用目的
B. the technical characteristics of the device B. 设备的技术特点
C.the labeling C.标签
D. the design complexity D. 设计复杂度
8. qquad\qquad devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. 8. qquad\qquad 设备通常是那些支持或维持人类生命的设备，对防止损害人类健康具有重大意义的设备，或者存在潜在的、不合理的疾病或伤害风险的设备。
A. Class I A. I 类
B. Class II B. II 类
C. Class III C. III 类
D. Class IV D. IV 类
9．Most medical devices are considered qquad\qquad devices． 9.大多数医疗器械被视为 qquad\qquad 器械。
A．Class I 一个。 I 类
B．Class II B． II 类
C．Class III C.III 类
D．Class IV D.IV 级
10．Tongue depressor is a qquad\qquad device． 10.压舌板是一种 qquad\qquad 装置。
A．Class I 一个。 I 类
B．Class II B． II 类
C．Class III C.III 类
D．Class IV D.IV 级
11．X－rays machine is a qquad\qquad device． 11.X 光机是一种 qquad\qquad 设备。
A．Class I 一个。 I 类
B．Class II B． II 类
C．Class III C.III 类
D．Class IV D.IV 级
12．Implantable pacemaker is a qquad\qquad device． 12.植入式起搏器是一种 qquad\qquad 装置。
A．Class I 一个。 I 类
B．Class II B． II 类
C．Class III C.III 类
D．Class IV D.IV 级
13. qquad\qquad determines，among other things，the type of premarketing submission／application required for FDA clearance to market． 13. qquad\qquad 确定 FDA 批准上市所需的上市前提交/申请类型。
A．The class to which a device is assigned A.设备分配到的类
B．The Intended Purpose for Use B.预期使用目的
C．The technical characteristics of the device C.设备的技术特点
D．The design complexity D.设计复杂度
III．In pairs，discuss and write definitions for the following terms from the text．You might use the internet to help you． III.In 成对，讨论并写下文本中以下术语的定义。您可以使用互联网来帮助您。
1．medical device 1.医疗器械
2．FDA 2.美国食品药品监督管理局
3．GHTF 3.GHTF
4．Class III device 4.III 类设备
IV．Translate the following sentences into Chinese． IV.将以下句子翻译成中文。
1．If the primary intended use of the product is achieved through chemical action or by being metabolized by the body，the product is usually a drug． 1.如果产品的主要预期用途是通过化学作用或被身体代谢实现的，则该产品通常是一种药物。
2．According to the standards of the U．S．Food and Drug Administration，a medical device（MD） may be classified as Class I，Class II，and III，with Class III covering the highest risk products． 2.根据美国食品药品监督管理局（FDA）的标准，医疗器械可分为 I 类、II 类和 III 类，其中 III 类涵盖风险最高的产品。
3．Class III devices are usually those that support or sustain human life，are of substantial importance in preventing impairment of human health，or which present a potential， 3.III 类器械通常是那些支持或维持人类生命的器械，对防止人类健康损害具有重大意义，或具有潜在
unreasonable risk of illness or injury. 不合理的疾病或受伤风险。
V. In small groups, surf the website of FDA and complete the following tasks. V. 以小组形式浏览 FDA 的网站并完成以下任务。
Your company, Shanghai ABC medical device company, deals with the production of stethoscope and thermometer. Now you intend to export your products to USA. However, to enter into the US market, you must understand the relevant FDA regulations and obtain the approval of FDA. 您的公司，上海 ABC 医疗器械公司，经营听诊器和温度计的生产。现在您打算将产品出口到美国。但是，要进入美国市场，您必须了解相关的 FDA 法规并获得 FDA 的批准。
Please complete the following tasks together with your team. 请与您的团队一起完成以下任务。
Step one: 第一步：
Visit the FDA website and search the classification of the following devices. 访问 FDA 网站并搜索以下器械的分类。
Manual Stethoscope 手动听诊器
Electronic Stethoscope 电子听诊器
Clinical Mercury Thermometer 临床水银温度计
Step two: 第二步：
Please identify the review panels (medical specialties) of the above medical devices. 请注明上述医疗仪器的审查小组（医学专科）。
Manual Stethoscope 手动听诊器
Electronic Stethoscope 电子听诊器
Clinical Mercury Thermometer 临床水银温度计
Step three: 第三步：
Please check out the product codes of these products. 请查看这些产品的产品代码。
Manual Stethoscope 手动听诊器
Electronic Stethoscope 电子听诊器
Clinical Mercury Thermometer 临床水银温度计
Step four: 第四步：
Please check out the regulation numbers of these products. 请查看这些产品的法规编号。
Manual Stethoscope 手动听诊器
Electronic Stethoscope 电子听诊器
Clinical Mercury Thermometer 临床水银温度计
Step five: 第五步：
What type of submission must you submit to the FDA before putting these products into the U.S. market? 在将这些产品推向美国市场之前，您必须向 FDA 提交什么类型的提交？
Project 2 项目 2
Electrophysiological Diagnostic Instrument 电生理诊断仪
Learning Objectives 学习目标
After studying project 2 , you should be able to: 学习项目 2 后，您应该能够：
acquire a general knowledge of the development of electrocardiograph and electroencephalograph 获得心电图仪和脑电图发展的一般知识
get acquainted with the working principles of ECG and EEG 熟悉心电图和脑电图的工作原理
grasp the professional terms about ECG and EEG 掌握有关心电图和脑电图的专业术语
understand 12-lead ECG, the most commonly used lead system throughout the world 了解 12 导联心电图，这是全球最常用的导联系统
understand the types of brain waves 了解脑电波的类型
Electrophysiological techniques are vital to modern biology in general and are of particular significance in neuroscience. 电生理技术通常对现代生物学至关重要，在神经科学中具有特别重要的意义。
Section 1 Electrocardiograph 第 1 节 心电图仪
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Discuss the following questions in pairs or small groups. 两人一组或分成小组讨论以下问题。
Did you ever receive an ECG test? 您是否接受过心电图检查？
Why do we use ECG test? 我们为什么使用心电图测试？
How is ECG test done? 心电图测试是如何进行的？
Do you think ECG test is risky or not? Why? 您认为心电图检查有风险吗？为什么？
The Invention of ECG 心电图的发明
Willem Einthoven (21 May 1860-29 September 1927) was a Dutch doctor and physiologist. He invented the first practical electrocardiogram (ECG or EKG) in 1903 and received the Nobel Prize in Medicine in 1924 for it. Before Einthoven’s time, it was known that the beating of the heart produced electrical currents, but the instruments of the time could not accurately measure this phenomenon without placing electrodes directly on the heart. 威廉·爱因霍芬（Willem Einthoven，1860 年 5 月 21 日 - 1927 年 9 月 29 日）是一位荷兰医生和生理学家。他于 1903 年发明了第一台实用心电图（ECG 或 EKG），并因此于 1924 年获得诺贝尔医学奖。在艾因托芬的时代之前，众所周知心脏的跳动会产生电流，但如果不将电极直接放在心脏上，当时的仪器就无法准确测量这种现象。
Beginning in 1901, Einthoven completed a series of prototypes of a string galvanometer. This device used a very thin filament of conductive wire passing between very strong electromagnets. When a current passed through the filament, the electromagnetic field would cause the string to move. A light shining on the string would cast a shadow on a moving roll of photographic paper, thus forming a continuous curve showing the movement of the string. This device increased the sensitivity of the standard galvanometer so that the electrical activity of the heart could be measured despite the insulation of flesh and bones. The original machine required 5 people to operate it and weighed some 600 lb . There is a photograph of an early ECG device, showing the manner in which the electrodes are attached to the patient, in this 从 1901 年开始，Einthoven 完成了一系列串式电流计的原型。该装置使用一根非常细的导线丝穿过非常强的电磁铁。当电流通过灯丝时，电磁场会导致灯串移动。照射在琴弦上的光线会在移动的相纸卷上投下阴影，从而形成一条连续的曲线，显示琴弦的运动。该设备提高了标准检流计的灵敏度，因此尽管肉和骨头是绝缘的，但仍然可以测量心脏的电活动。原来的机器需要 5 个人来作，重约 600 磅。有一张早期心电图设备的照片，显示了电极连接到患者身上的方式，其中
case the hands and one foot being immersed in jars of salt solution． 如果手和一只脚浸入盐溶液罐中。
In 1924，Einthoven was awarded the Nobel Prize in Medicine for inventing the first practical system of electrocardiography used in medical diagnosis． 1924 年，Einthoven 因发明了第一个用于医学诊断的实用心电图系统而获得诺贝尔医学奖。
Cardiac electrophysiology is dedicated to the study of the electrochemical activity of the heart．Studies include electrical activation of individual cells as well as the system－level activation，which results in normal or abnormal heart rhythms． 心脏电生理学是专门研究心脏电化学活动的学科，研究包括单个细胞的电激活以及导致正常或异常心律的系统级激活。
The electrocardiogram（ECG or EKG）is a diagnostic tool that measures and records the electrical activity of the heart in exquisite detail．The ECG can serve in diagnosis to provide a variety of information regarding the heart＇s normal function，as well as provide information about heart rhythm abnormalities．Interpretation of these details allows diagnosis of a wide range of heart conditions．These conditions can vary from minor to life threatening． 心电图（ECG 或 EKG）是一种诊断工具，可以详细地测量和记录心脏的电活动。心电图可以在诊断中提供有关心脏正常功能的各种信息，以及提供有关心律异常的信息。对这些细节的解释可以诊断各种心脏病。这些病症可以从轻微到危及生命不等。
To fully understand how an ECG reveals useful information about the condition of your heart requires a basic understanding of the anatomy（that is，the structure）and physiology（that is，the function）of the heart． 要完全了解心电图如何揭示有关心脏状况的有用信息，需要对心脏的解剖学（即结构）和生理学（即功能）有基本的了解。
The human heart is four－chambered consisting of two atria and two ventricles．The heart is pear shaped and about the size of a fist．The heart is located beneath the protective ribs on the left side．The heart is an involuntary muscle，meaning that unlike the leg or arm muscles， 人类的心脏有四个腔室，由两个心房和两个心室组成。心脏呈梨形，大约有拳头大小。心脏位于左侧的保护肋下方。心脏是一块不自主的肌肉，这意味着与腿部或手臂肌肉不同，
the cardiac muscle is not under voluntary control. A natural electrical system causes the heart muscle to contract and pump blood through the heart to the lungs and the rest of the body. 心肌不受自主控制。自然的电系统使心肌收缩，并将血液通过心脏泵送到肺部和身体的其他部位。
The electrical activities can be studied by picking up potentials on the body surface. The potentials originate in the individual fibers of the heart muscle and are summated to give the waveforms of the electrocardiogram. 可以通过拾取体表的电位来研究电活动。电位起源于心肌的单个纤维，并相加得出心电图的波形。
The term electrocardiogram was introduced by Willem Einthoven in 1893 at a meeting of the Dutch Medical Society. In 1924, Einthoven received the Nobel Prize for his life’s work in developing the ECG. The ECG has evolved over the years. 心电图一词由 Willem Einthoven 于 1893 年在荷兰医学会的一次会议上提出。1924 年，Einthoven 因其毕生在开发心电图方面的工作而获得诺贝尔奖。心电图多年来不断发展。
12-lead ECG 12 导联心电图
The standard 12-lead ECG was introduced in 1942, and until today is still the most commonly used lead system throughout the world. 标准的 12 导联心电图于 1942 年推出，直到今天仍然是世界上最常用的导联系统。
It is called a 12-lead ECG because it takes 12 leads to give the physician different views of the heart’s activity. It examines the electrical activity of the heart from 12 points of view. The standard 12-lead electrocardiogram is a representation of the heart’s electrical activity recorded from electrodes on the body surface. This is necessary because no single point (or even 2 or 3 points of view) provides a complete picture of what is going on. 它被称为 12 导联心电图，因为需要 12 导联才能为医生提供心脏活动的不同视图。它从 12 个角度检查心脏的电活动。标准的 12 导联心电图表示体表电极记录的心脏电活动。这是必要的，因为没有一个点（甚至 2 或 3 个观点）可以完整地了解正在发生的事情。
The leads of the 12 lead ECG comprise 6 Limb Leads (the standard bipolar limb leads I, II, and III, the augmented unipolar limb leads AVR, AVL, and AVF) and 6 standard Precordial or Chest Leads (V_(1),V_(2),V_(3),V_(4),V_(5):}\left(\mathrm{V}_{1}, \mathrm{~V}_{2}, \mathrm{~V}_{3}, \mathrm{~V}_{4}, \mathrm{~V}_{5}\right. and {:V_(6))\left.\mathrm{V}_{6}\right). 12 导联心电图的导联包括 6 个肢体导联（标准双极肢体导联 I、II 和 III，增强的单极肢体导联 AVR、AVL 和 AVF）和 6 个标准心前区或胸导联 (V_(1),V_(2),V_(3),V_(4),V_(5):}\left(\mathrm{V}_{1}, \mathrm{~V}_{2}, \mathrm{~V}_{3}, \mathrm{~V}_{4}, \mathrm{~V}_{5}\right. 和 {:V_(6))\left.\mathrm{V}_{6}\right) .
Figure1 Showing a Patient Connected to the 10 Electrodes Necessary for A 12-lead ECG 图 1 显示了连接到 12 导联心电图所需的 10 个电极的患者
Limb Leads：Vertical Plane 肢体引线：垂直平面Bipolar Limb Leads－Standard Leads I，II and III 双极肢体导联 - 标准导联 I、II 和 IIIA lead composed of two electrodes of opposite polarity is called bipolar lead． 由两个极性相反的电极组成的引线称为双极引线。Lead I：Right arm－negative，Left arm－positive 导联 I：右臂阴性，左臂阳性Records electrical differences between the left and right arm electrodes． 记录左臂和右臂电极之间的电气差异。Lead II：Right arm－negative，Left leg－positive 导联 II：右臂阴性，左腿阳性Records electrical difference between the left leg and right arm electrodes． 记录左腿和右臂电极之间的电气差异。Lead III：Left arm－negative，Left leg－positive 导联 III：左臂阴性，左腿阳性Records electrical differences between the left leg and left arm electrodes． 记录左腿和左臂电极之间的电气差异。
Augmented Unipolar Limb Lead 增强的单极肢体导联
The other three frontal plane limb leads are called the augmented unipolar leads．A lead composed of a single positive electrode and a reference point is a unipolar lead．Augmented unipolar limb lead is a modified unipolar limb lead；the three standard leads are：aVF（left leg）， aVL（left arm），and aVR（right arm）． 其他三种额面肢导联称为增广单极导联，由单个正极和参考点组成的导联为单极导联。增广单极肢导联是改良的单极肢导联;三种标准导联为：aVF（左腿）、aVL（左臂）和 aVR（右臂）。
The EKG machine records potential differences and，therefore，the technique is Bipolar （potential site A minus potential site B）．However，if the potential of B is zero，the recorder records only the potential site A．This means that these next three electrodes，for all practical purposes，have a zero potential and do not change during the cardiac cycle．They became known as the indifferent electrodes，and all three leads became known as UNIPOLAR leads． 心电图机记录电位差，因此，该技术是双极的（电位位点 A 减去电位位点 B）。但是，如果 B 的电位为零，记录仪只记录电位位点 A.这意味着接下来的三个电极，就所有实际目的而言，电位为零，并且在心动周期期间不会改变。它们被称为无差别电极，所有三个导联都被称为单极导联。
aVF lead－an augmented unipolar limb lead in which the positive electrode is on the left leg． aVF 导联 - 一种增强的单极肢体导联，其中正极位于左腿上。
aVL lead－an augmented unipolar limb lead in which the positive electrode is on the left arm． aVL 导联 - 一种增强的单极肢体导联，其中正极位于左臂上。
aVR lead－an augmented unipolar limb lead in which the positive electrode is on the right arm． aVR 导联 - 一种增强的单极肢体导联，其中正极位于右臂上。
As mentioned earlier，unipolar leads measure the electric impulses at only one point， instead of across two points，as the first three leads．With these UNIPOLAR leads，the second site is＂ 0 ＂，so there is no need to measure from two points，only one point is needed．To obtain the measurements from these UNIPOLAR leads，you simply turn the dial on the EKG machine to aVR,aVL\mathrm{aVR}, \mathrm{aVL} ，and aVF ，respectively．The machine automatically makes the needed connection to measure the voltage from these areas． 如前所述，单极导联只在一个点测量电脉冲，而不是像前三个导联那样跨两个点测量，使用这些单极导联，第二个位置是“0”，所以不需要从两个点测量，只有一个点 needed.To 从这些单极导联上获得测量值，您只需将心电图机上的刻度盘分别转到 aVR,aVL\mathrm{aVR}, \mathrm{aVL} 和 aVF ，机器会自动进行所需的连接以测量电压这些领域。
The six limb leads measure a copulate circle or 360 degrees around the heart．They measure the electrical activity of the heart from every possible angle．The reason for this is obvious．By measuring the heart from different angles，you will be able to pinpoint the location 六根肢体导线测量一个交配圈或围绕心脏 360 度。它们从每个可能的角度测量心脏的电活动。这样做的原因是 obvious.By 从不同角度测量心脏，您将能够确定位置
of any conduction defective in the heart. 心脏中任何有缺陷的传导。
Precordial Leads: horizontal plane 心前区导联：水平面
To obtain more detailed information on potential variations in different parts of the heart, electrodes are placed on the chest, close to the heart at the anatomic points. An indifferent electrode is formed by connecting three equal large resistances to the left arm, right arm and left leg. 为了获得有关心脏不同部位潜在变化的更多详细信息，将电极放置在胸部，靠近心脏的解剖点。通过将三个相等的大电阻连接到左臂、右臂和左腿来形成一个无差别电极。
precordial leads-leads in which the exploring electrode is placed on the chest and the other is connected to one or more limbs. 心前区导联 - 其中探查电极放置在胸部，另一个连接到一个或多个肢体。
The precordial (chest leads) leads each consist of a positive electrode strategically placed on the chest of the patient. The positions of the positive electrode for the six precordial leads are very important for a valid tracing to be made on the ECG machine. 心前区（胸导联）导联每个导联都由一个战略性地放置在患者胸部的正极组成。六个心前区导联的正极位置对于在 ECG 机上进行有效跟踪非常重要。
These positions are: 这些职位是：
V_(1)\mathrm{V}_{1}
positioned: 定位：
Fourth intercostals space, right sterna border. 第四肋间隙，右胸骨边界。
V_(2)\mathrm{V}_{2}
positioned: 定位：
Fourth intercostals space, left sterna border. 第四肋间隙，左胸骨缘。
V_(3)\mathrm{V}_{3}
positioned: 定位：
Midway between V_(1)V_{1} and V_(4)V_{4} in straight line with them. 在它们之间 V_(1)V_{1} 并 V_(4)V_{4} 与之成直线。
V_(4)\mathrm{V}_{4}
positioned: 定位：
Fifth intercostals space, left midclavicular line. 第五肋间隙，左锁骨中线。
V_(5)\mathrm{V}_{5}
positioned: 定位：
Fifth intercostals space, left anterior auxiliary line. 第五肋间隙，左前辅助线。
V_(6)\mathrm{V}_{6}
positioned: 定位：
Fifth intercostals space, left midauxiliary line. 第五肋间间隙，左中辅助线。
V_(1) positioned: Fourth intercostals space, right sterna border.
V_(2) positioned: Fourth intercostals space, left sterna border.
V_(3) positioned: Midway between V_(1) and V_(4) in straight line with them.
V_(4) positioned: Fifth intercostals space, left midclavicular line.
V_(5) positioned: Fifth intercostals space, left anterior auxiliary line.
V_(6) positioned: Fifth intercostals space, left midauxiliary line.| $\mathrm{V}_{1}$ | positioned: | Fourth intercostals space, right sterna border. |
| :--- | :--- | :--- |
| $\mathrm{V}_{2}$ | positioned: | Fourth intercostals space, left sterna border. |
| $\mathrm{V}_{3}$ | positioned: | Midway between $V_{1}$ and $V_{4}$ in straight line with them. |
| $\mathrm{V}_{4}$ | positioned: | Fifth intercostals space, left midclavicular line. |
| $\mathrm{V}_{5}$ | positioned: | Fifth intercostals space, left anterior auxiliary line. |
| $\mathrm{V}_{6}$ | positioned: | Fifth intercostals space, left midauxiliary line. |
These positions are critical for interpretation of the EKG．At first it may seem complicated to position these electrodes．After some practice it is relatively easy to place the leads properly． 这些位置对于解释 EKG.At 至关重要，首先，放置这些电极似乎很复杂。经过一些练习，正确放置导联相对容易。
The 12－lead ECG gives a tracing from 12 different＂electrical positions＂of the heart．Each lead is meant to pick up electrical activity from a different position on the heart muscle．This allows an experienced interpreter to see the heart from many different angles． 12 导联心电图从心脏的 12 个不同的“电位置”进行追踪。每个导联都用于从心肌的不同位置获取电活动。这使得经验丰富的口译员可以从许多不同的角度观察心脏。
Figure 2 Twelve－lead EKG of A 26－year－old Male 图 2 一名 26 岁男性的 12 导联心电图
The 12－lead ECG is an important and useful tool for localization of origin of arrhythmias． 12 导联心电图是定位心律失常起源的重要且有用的工具。
Ambulatory ECG 动态心电图
Some people with heart rhythm disorders（arrhythmia）or coronary heart disease have symptoms that come and go．These symptoms may include brief chest pain or angina， palpitations，dizziness，or weakness．If you are not having symptoms when you see your health care provider，your ECG result may be perfectly normal．This is a common occurrence，and it is frustrating because your health care provider cannot properly diagnose or treat your problem until it has been documented on ECG． 一些心律失常（心律失常）或冠心病患者的症状时有时无。这些症状可能包括短暂的胸痛或心绞痛、心悸、头晕或虚弱。如果您在看医疗保健提供者时没有症状，您的心电图结果可能是完全正常的。这是常见的情况，令人沮丧的是，您的医疗保健提供者无法正确诊断或治疗您的问题，直到心电图记录下来。
Ambulatory ECG is a good way to＂catch＂and document any temporary or intermittent abnormalities such as irregular heartbeats． 动态心电图是“捕捉”和记录任何暂时或间歇性异常（例如心律不齐）的好方法。
For this test，you are attached to an ECG recording device（sometimes called a Holter monitor）that records every heartbeat for periods of 24 hours（or longer，if necessary）．An alternative method is to record the heartbeats only intermittently but for a longer period of time， days or weeks．Long－term monitoring significantly increases your chances of＂catching＂any 对于这项测试，您将连接到一个心电图记录设备（有时称为动态心电图监测器），该设备记录 24 小时（或更长时间，如有必要）的每次心跳。另一种方法是仅间歇性地记录心跳，但记录时间更长，几天或几周。长期监测会显著增加您“捕获”任何
abnormalities on the ECG，even if they last only a few minutes or seconds． 心电图异常，即使它们只持续几分钟或几秒钟。
1．The ECG can serve in diagnosis to provide a variety of information regarding the heart＇s normal function，as well as provide information about heart rhythm abnormalities． 1.心电图可用于诊断，提供有关心脏正常功能的各种信息，以及提供有关心律异常的信息。
在诊断中，心电图可以提供关于心脏的正常功能，以及心律异常等各种信息。
2．The potentials originate in the individual fibers of the heart muscle and are summated to give the waveforms of the electrocardiogram． 2.电位起源于心肌的单个纤维，并汇总得出心电图的波形。
这些电位起源于心肌的个体纤维中，并综合给出心电图的波形。
3．The standard 12 －lead electrocardiogram is a representation of the heart＇s electrical activity recorded from electrodes on the body surface． 3.标准的 12 导联心电图表示体表电极记录的心脏电活动。
标准 12 导联心电图代表了从身体表面各电极所记录的心脏电行为。
4．The positions of the positive electrode for the six precordial leads are very important for a valid tracing to be made on the ECG machine． 4.六个心前区导联的正极位置对于在心电图机上进行有效跟踪非常重要。
六个前胸导联中正电极的位置对于心电图能否产生有效波形非常重要。
5．Ambulatory ECG is a good way to＂catch＂and document any temporary or intermittent abnormalities such as irregular heartbeats． 5.动态心电图是“捕捉”和记录任何暂时或间歇性异常（如心律不齐）的好方法。
动态心电图可以捕捉和记录任何短暂的或者间歇的异常比如心律不齐。
Pacelionl okdile
I．In pairs or small groups，discuss the questions． I.In 两人或小组，讨论问题。
1．Is it necessary to choose standard positions when recording electrocardiograms？Why？ 记录心电图时 1.Is 需要选择标准位置吗？为什么？
2．What do AVR，AVL and AVF stand for？ 2.AVR、AVL 和 AVF 代表什么？
3．What is a bipolar lead？ 3.什么是双极导联？
4．What is the principle of unipolar lead？ 4.单极引线的原理是什么？
5．How can we obtain unipolar leads in an ECG test？ 5.我们如何在心电图测试中获得单极导联？
II．Choose the best answer． II.选择最佳答案。
1．What is cardiac electrophysiology？ 1.什么是心脏电生理学？
A．It is the study of electrochemical activity of the heart A.It 是对心脏电化学活动的研究
B．It is the study of heart B.It 是对心灵的研究
C．It is the study of physics C.It 是物理学
D．It is the study of the electrochemical activity of the brain D.It 是对大脑电化学活动的研究
2．The human heart is composed of qquad\qquad chambers． 2.人的心脏是由 qquad\qquad 腔室组成的。
A．Two A.二
B．Three B． 三
C．Four C.四
D．Five D.五
3．What causes the heart to contract and pump blood through the heart to the lungs and the rest of the body？ 3.是什么导致心脏收缩并通过心脏将血液泵送到肺部和身体的其他部位？
A．An electric pacemaker A.电动起搏器
B．A natural electrical system B.A 自然电气系统
C．The heart muscle C.心肌
D．potential D.电位
4．Which statement is not true about the first prototype of ECG？ 4.关于心电图的第一个原型，哪些陈述是不正确的？
A．It used a thin filament of conductive wire passing through strong electromagnet A.It 使用了一根穿过强电磁铁的导电丝细丝
B．It was a kind of string galvanometer B.It 是一种串式电流计
C．The use of photographic paper which showed the shadow of the string movement increased the sensitivity of the galvanometer C.使用显示琴弦运动阴影的相纸提高了检流计的灵敏度
D．The patient＇s hands and one foot should be immersed in jars of clean water D.患者的手和一只脚应浸入装有清水的罐子中
5. qquad\qquad is the most commonly used lead system throughout the world． 5. qquad\qquad 是世界上最常用的铅系统。
A．3－lead ECG A.3 导联心电图
B．6－lead ECG B.6 导联心电图
C．9－lead ECG C.9 导联心电图
D．12－lead ECG D.12 导联心电图
6．The leads of the 12 lead ECG comprise qquad\qquad Limb Leads and qquad\qquad standard Precordial or Chest Leads． 6.12 导联心电图的导联包括 qquad\qquad 肢体导联和 qquad\qquad 标准心前区或胸部导联。
A． 3,9 一个。 3,9
B． 6,6
C． 4 ， 8
D． 8,4
7．A lead composed of two electrodes of opposite polarity is called qquad\qquad ． 7.由两个极性相反的电极组成的引线称为 qquad\qquad 。
A．bipolar lead A.双极导联
B．unipolar lead B.单极导联
C．augmented lead C.增强导程
D．standard lead D.标准导程
8．If one electrode has a zero potential and does not change during the cardiac cycle，the lead is a qquad\qquad ． 8.如果一个电极的电位为零，并且在心动周期期间没有变化，则导联为 。 qquad\qquad
A．bipolar lead A.双极导联
B．unipolar lead B.单极导联
C．augmented lead C.增强导程
D．standard lead D.标准导程
9．Precordial leads measure the electrical activity of the heart from the qquad\qquad plane． 9.心前区导联从 qquad\qquad 平面测量心脏的电活动。
A．vertical A.立式
B．horizontal B.水平
C．craniocaudal C.颅尾
D．dorsoventral D.背腹
10．Which statement is not true about ambulatory ECG？ 10.关于动态心电图的哪项陈述不正确？
A．It is also called Holter monitor A.It 也称为动态心电图监测仪
B．It is a good way to catch and document any temporary or intermittent abnormalities B.It 是捕获和记录任何暂时性或间歇性异常的好方法
C．It is used in an ambulance C.It 用于救护车
D．It is a kind of long－term cardiac monitoring device D.It 是一种长期心脏监测设备
11．If the patient＇s heart disease has intermittent symptoms，he／she should be diagnosed with qquad\qquad ． 11.如果患者的心脏病有间歇性症状，他/她应该被诊断为 qquad\qquad 。
A．ambulatory ECG A.动态心电图
B．12－lead ECG B.12 导联心电图
C．EEG C.脑电图
D．ambulatory EEG D.动态脑电图
12．The heart is an qquad\qquad muscle． 12. 心脏是一块 qquad\qquad 肌肉。
A．involuntary A.非自愿
B．voluntary B.自愿
C．active C.主动
D．accidental D.意外
13. qquad\qquad have a zero potential and do not change during the cardiac cycle. 13. qquad\qquad 电位为零，在心动周期期间不会改变。
A. Indifferent electrodes A. 无差别电极
B. Exploring electrodes B. 探索电极
C. Unipolar electrodes C. 单极电极
D. Bipolar electrodes D. 双极电极
III. In pairs, discuss and write definitions for the following terms from the text. You might use the internet to help you. III. 两人一组，讨论并写下文本中以下术语的定义。您可能会使用互联网来帮助您。
electrocardiograph 心电图
electrophysiology 电生理学
bipolar lead 双极导联
unipolar lead 单极引线
12-lead ECG 12 导联心电图
IV. Translate the following sentences into Chinese. IV. 将以下句子翻译成中文。
The electrocardiogram (ECG or EKG) is a diagnostic tool that measures and records the electrical activity of the heart in exquisite detail. 心电图（ECG 或 EKG）是一种诊断工具，可以详细地测量和记录心脏的电活动。
Augmented unipolar limb lead is a modified unipolar limb lead; the three standard leads are: aVF (left leg), aVL (left arm), and aVR (right arm). 增强的单极肢体导联是一种改良的单极肢体导联;三种标准导联是：aVF（左腿）、aVL（左臂）和 aVR（右臂）。
They became known as the indifferent electrodes, and all three leads became known as UNIPOLAR leads or exploring electrodes. 它们被称为冷漠电极，所有三个导联都被称为单极导联或探矿电极。
This is a common occurrence, and it is frustrating because your health care provider cannot properly diagnose or treat your problem until it has been documented on ECG. 这是很常见的情况，而且令人沮丧，因为在心电图记录之前，您的医疗保健提供者无法正确诊断或治疗您的问题。
V. Read and complete the text using the words below. V. 使用以下单词阅读并完成文本。
The big qquad\qquad (1) in R&D tend to produce certain types of product-things like qquad\qquad (2) scientific instruments, medicines, medical devices, high-tech weapon systems, navigation and safety devices for aircraft etc. Whereas, typically, a manufacturing company might make a profit of 40%40 \% on its sales, the profits of these qquad\qquad companies can range from 60%60 \% to as high 研发中的大 qquad\qquad 公司（1）倾向于生产某些类型的产品-如 qquad\qquad （2）科学仪器、药品、医疗设备、高科技武器系统、飞机导航和安全设备等。虽然通常制造公司可能会从 40%40 \% 其销售中获利，但这些 qquad\qquad 公司的利润可以从 60%60 \%
as 90%90 \% ．In other words，manufacturing qquad\qquad （4） represent only 10%10 \% of the price that the qquad\qquad （5） pays for the product－the remaining 90%90 \% being qquad\qquad （6） ．One might ask how these companies can justify figures like these．The explanation lies in the fact that， for them，R\＆D carries a high risk of qquad\qquad （7） ．A large part of the time and money that they qquad\qquad （8） in R\＆D does not create any qquad\qquad （9） products at all．So the high profits of a handful of successful products serve to offset the cost of numerous qquad\qquad （10） projects． 换句话说 90%90 \% ，制造业 qquad\qquad （4） 只 10%10 \% 代表 qquad\qquad （5） 为产品支付的价格——剩下的 90%90 \% 是 qquad\qquad （6） .有人可能会问这些公司如何证明这样的数字是合理的。解释在于，对他们来说，研发具有 qquad\qquad （7） 的高风险 .他们 qquad\qquad （8） 在研发中的大部分时间和金钱并没有创造任何 qquad\qquad （9） 产品 all.So 少数成功产品的高利润用于抵消众多 qquad\qquad （10） 项目的成本。
VI．In pairs or small groups，complete the following tasks． VI.In 两人一组或小组中，完成以下任务。
a．In pairs，role play a conversation in which a scientist from an R\＆D－intensive company explains the economics of R\＆D investment to a layperson． a.In 对，角色扮演一个对话，其中一位来自研发密集型公司的科学家向外行解释研发投资的经济学。
b．In small groups，locate information online and offline to identify the latest development of ECG． Brainstorm and boldly predict the future trend of ECG technology． b.In 小组中，在线和离线查找信息，以确定心电图的最新发展。集思广益，大胆预测心电技术的未来趋势。
Section 2 Electroencephalograph 第 2 节 脑电图
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Discuss the following questions in pairs or small groups. 两人一组或分成小组讨论以下问题。
Have you ever heard of EEG? What is an EEG test? 你听说过脑电图吗？什么是脑电图测试？
Did you ever receive an EEG test? Why were you suggested to take the test? 你做过脑电图检查吗？为什么建议您参加测试？
How is an EEG test done? 脑电图测试是如何进行的？
Have you ever heard of electroshock therapy? Is it the same thing with EEG? 你听说过电击疗法吗？脑电图也是一样的吗？
If a patient is skeptical of epilepsy, what medical test will a doctor prescribe to him? Why? 如果患者对癫痫持怀疑态度，医生会给他开什么医学检查？为什么？
Stages of Sleep 睡眠阶段
The invention of the electroencephalograph allowed scientists to study sleep in ways that were not previously possible. During the 1950s, a graduate student named Eugene Aserinsky used this tool to discover what is known today as REM (rapid eye movement) sleep. 脑电图仪的发明使科学家能够以以前不可能的方式研究睡眠。在 1950 年代，一位名叫 Eugene Aserinsky 的研究生使用这个工具发现了今天所谓的 REM（快速眼动）睡眠。
Further studies of human sleep have demonstrated that sleep progresses through a series of stages in which different brain wave patterns are displayed. 对人类睡眠的进一步研究表明，睡眠会经历一系列阶段，在这些阶段中会显示不同的脑电波模式。
The Beginnings of Sleep 睡眠的开始
During the earliest phases of sleep, you are still relatively awake and alert. The brain produces what are known as beta waves, which are small and fast. As the brain begins to relax and slow down, slower waves known as alpha waves are produced. During this time when you are not quite asleep, you may experience strange and extremely vivid sensations known as hypnagogic hallucinations. Common examples of this phenomenon include feeling like you are falling or hearing someone call your name. Another very common event during this period is known as a myoclonic jerk. If you’ve ever startled suddenly for seemingly no reason at all, then you have experienced this odd phenomenon. 在睡眠的最初阶段，您仍然相对清醒和警觉。大脑产生所谓的 β 波，这种波小而快。当大脑开始放松和减慢时，会产生称为 α 波的较慢波。在这段时间里，当您没有完全睡着时，您可能会经历奇怪且极其生动的感觉，称为入睡幻觉。这种现象的常见例子包括感觉自己跌倒或听到有人叫你的名字。在此期间另一个非常常见的事件被称为肌阵挛性抽搐。如果您曾经无缘无故地突然受到惊吓，那么您已经经历过这种奇怪的现象。
Stage 1 is the beginning of the sleep cycle，and is a relatively light stage of sleep．Stage 1 can be considered a transition period between wakefulness and sleep．In Stage 1，the brain produces high amplitude theta waves，which are very slow brain waves．This period of sleep lasts only a brief time（around 5－10 minutes）．If you had awaken someone during this stage， they might report that they weren＇t really asleep． 阶段 1 是睡眠周期的开始，是睡眠中相对较轻的阶段。阶段 1 可以认为是清醒和 sleep.In 之间的过渡期阶段，大脑产生高振幅的 θ 波，这是非常缓慢的脑电波，这段睡眠期只持续很短的时间（大约 5-10 分钟）。如果你在这个阶段叫醒了某人，他们可能会报告说他们并没有真正睡着。
Stage 2 is the second stage of sleep and lasts for approximately 20 minutes．The brain begins to produce bursts of rapid，rhythmic brain wave activity．Body temperature starts to decrease and heart rate begins to slow． 第 2 阶段是睡眠的第二阶段，持续约 20 分钟。大脑开始产生快速、有节奏的脑电波活动。体温开始下降，心率开始减慢。
Stage 3 is a transitional period between light sleep and a very deep sleep．Deep，slow brain waves known as delta waves begin to emerge during Stage 3 sleep． 第 3 阶段是浅睡眠和极深睡眠之间的过渡期，在第 3 阶段睡眠期间，称为 delta 波的深而慢的脑电波开始出现。
Stage 4 is sometimes referred to as delta sleep because of the slow brain waves known as delta waves that occur during this time．Stage 4 is a deep sleep that lasts for approximately 30 minutes．Bed－wetting and sleepwalking are most likely to occur at the end of stage 4 sleep． 第 4 阶段有时被称为 delta 睡眠，因为在此期间会出现称为 delta 波的缓慢脑电波。第 4 阶段是持续约 30 分钟的深度睡眠。尿床和梦游最有可能发生在第 4 阶段睡眠结束时。
Most dreaming occurs during the fifth stage of sleep，known as rapid eye movement（REM） sleep．REM sleep is characterized by eye movement，increased respiration rate and increased brain activity．REM sleep is also referred to as paradoxical sleep because while the brain and other body systems become more active，muscles become more relaxed．Dreaming occurs due because of increased brain activity，but voluntary muscles become paralyzed． 大多数做梦发生在睡眠的第五阶段，称为快速眼动（REM）睡眠。REM 睡眠的特点是眼球运动、呼吸频率增加和大脑活动增加。REM 睡眠也被称为反常睡眠，因为当大脑和其他身体系统变得更加活跃时，肌肉变得更加放松。做梦是由于大脑活动增加，但随意肌变得麻痹。
It is important to realize，however，that sleep does not progress through these stages in sequence．Sleep cycles through these stages approximately four or five times throughout the night． 然而，重要的是要认识到，睡眠不会按顺序经历这些阶段。睡眠在整个晚上大约会循环经历这些阶段四到五次。
Electroencephalography (EEG) is the recording of electrical activity along the scalp produced by the firing of neurons within the brain. In clinical contexts, EEG refers to the recording of the brain’s spontaneous electrical activity over a short period of time, usually 20-20- 40 minutes, as recorded from multiple electrodes placed on the scalp. In neurology, the main diagnostic application of EEG is in the case of epilepsy, as epileptic activity can create clear abnormalities on a standard EEG study. A secondary clinical use of EEG is in the diagnosis of coma, encephalopathies, and brain death. EEG used to be a first-line method for the diagnosis of tumors, stroke and other focal brain disorders, but this use has decreased with the advent of anatomical imaging techniques such as MRI and CT. 脑电图 （EEG） 是大脑内神经元放电产生的头皮电活动的记录。在临床环境中，脑电图是指在短时间内（通常 20-20- 为 40 分钟）记录大脑的自发电活动，由放置在头皮上的多个电极记录下来。在神经病学中，脑电图的主要诊断应用是在癫痫的情况下，因为癫痫活动可以在标准脑电图研究中产生明显的异常。脑电图的次要临床用途是诊断昏迷、脑病和脑死亡。脑电图曾经是诊断肿瘤、中风和其他局灶性脑部疾病的一线方法，但随着 MRI 和 CT 等解剖成像技术的出现，这种使用已经减少。
What is an EEG? 什么是脑电图？
The brain normally produces tiny electrical signals that come from the brain cells and nerves that send messages to each other. These electrical signals can be detected and recorded by the EEG machine. Electroencephalography (EEG) is the recording of electrical activity along the scalp produced by the neurons within the brain. 大脑通常会产生来自脑细胞和神经的微小电信号，这些电信号会相互发送信息。这些电信号可以被脑电图机检测和记录。脑电图 （EEG） 是记录大脑内神经元沿头皮产生的电活动。
An EEG Recording 脑电图记录
Special sensors are attached to your head and hooked by wires to a computer．The computer records your brain＇s electrical activity on the screen or on paper as wavy lines． Certain conditions，such as seizures，can be seen by the changes in the normal pattern of the brain＇s electrical activity． 特殊的传感器连接到您的头部并通过电线连接到计算机。计算机将大脑的电活动记录在屏幕上或纸上，以波浪线的形式。某些情况，例如癫痫发作，可以通过大脑电活动的正常模式的变化来看到。
How is the test done？ 测试是如何进行的？
When you have the test，you will be asked to lie on your back on a bed or table or relax in a chair with your eyes closed．The EEG technologist will attach several small electrodes to your scalp，using a sticky paste to hold the electrodes in place．A cap with fixed electrodes may be placed on your head instead of individual electrodes． 当您进行检查时，您将被要求仰卧在床或桌子上，或闭上眼睛在椅子上放松。脑电图技师将几个小电极连接到您的头皮上，使用粘性糊状物将电极固定到位。可以将带有固定电极的帽子放在您的头上，而不是单独的电极。
The technologist may ask you to do different things during the test to record what activity your brain does at that time． 技术人员可能会要求您在测试期间做不同的事情，以记录您的大脑当时进行的活动。
If the doctor thinks that a person has epilepsy but the EEG is normal，the technologist running the EEG test may have the person look at a flashing light（photic stimulation），breathe fast and deeply（hyperventilation），or sleep during the test．These techniques sometimes show epileptic EEG patterns that did not show up at first． 如果医生认为一个人患有癫痫，但脑电图正常，进行脑电图测试的技术人员可能会让患者在测试期间看闪光（光刺激），快速和深呼吸（换气过度），或睡觉。
You may be asked to look at a bright，flashing light called a strobe．This is called photic or stroboscopic stimulation． 您可能会被要求注视称为频闪的明亮闪烁的光。这称为光刺激或频闪刺激。
You may be asked to breathe deeply and rapidly（hyperventilate）．Usually you will take 20 breaths a minute for 3 minutes． 您可能会被要求深呼吸和快速呼吸（换气过度），通常您会每分钟呼吸 20 次，持续 3 分钟。
You may be asked to go to sleep．If you cannot fall asleep，you may be given a sedative to help you fall asleep．If an EEG is being done to check a sleep problem，an all－night recording of your brain＇s electrical activity may be done． 您可能会被要求入睡。如果您无法入睡，可能会给您注射镇静剂以帮助您入睡。如果正在进行脑电图检查以检查睡眠问题，则可能会整夜记录您大脑的电活动。
Why It Is Done 目的
An electroencephalogram（EEG）may be done to： 脑电图 （EEG） 可以用于：
Diagnose epilepsy and see what type of seizures are occurring．EEG is the most useful and important test in confirming a diagnosis of epilepsy． 诊断癫痫并查看发生的癫痫发作类型。EEG 是确认癫痫诊断的最有用和最重要的测试。
Check for problems with loss of consciousness or dementia． 检查是否有意识丧失或痴呆问题。
Help find out a person＇s chance of recovery after a change in consciousness． 帮助找出一个人在意识改变后恢复的机会。
Find out if a person who is in a coma is brain－dead． 找出昏迷的人是否脑死亡。
Study sleep disorders，such as narcolepsy． 研究睡眠障碍，例如发作性睡病。
Watch brain activity while a person is receiving general anesthesia during brain surgery． 在脑部手术期间，当一个人接受全身麻醉时观察大脑活动。
Help find out if a person has a physical problem (problems in the brain, spinal cord, or nervous system) or a mental health problem. 帮助查明一个人是否有身体问题（大脑、脊髓或神经系统问题）或心理健康问题。
Risks 风险
An electroencephalogram (EEG) is a very safe test. The EEG test is painless and harmless. The electrical activity of your brain is recorded, but at no time is any electrical current put into your body. An EEG should not be confused with electroshock (electroconvulsive) therapy. 脑电图 （EEG） 是一种非常安全的测试。脑电图测试无痛无害。您大脑的电活动被记录下来，但在任何时候都不会将任何电流输入您的身体。不应将脑电图与电休克（电休克）疗法混淆。
If you have a seizure disorder such as epilepsy, a seizure may be triggered by the flashing lights or by hyperventilation. If this occurs, the technologist is trained to take care of you during the seizure. 如果您患有癫痫等癫痫发作，癫痫发作可能是由闪光灯或换气过度引发的。如果发生这种情况，技师接受过培训，可以在癫痫发作期间照顾您。
Results 结果
There are several types of brain waves: 脑电波有几种类型：
Alpha waves have a frequency of 8 to 12 cycles per second. Alpha waves are present only in the waking state when your eyes are closed but you are mentally alert. Alpha waves go away when your eyes are open or you are concentrating. Alpha 波的频率为每秒 8 到 12 个周期。α 波仅在您闭上眼睛但精神警觉的清醒状态下存在。当您睁开眼睛或集中注意力时，α 波会消失。
Beta waves have a frequency of 13 to 30 cycles per second. These waves are normally found when you are alert or have taken high doses of certain medicines, such as benzodiazepines. β 波的频率为每秒 13 到 30 个周期。这些波动通常在您保持警觉或服用高剂量的某些药物（如苯二氮卓类药物）时发现。
Delta waves have a frequency of less than 3 cycles per second. These waves are normally found only when you are asleep or in young children. Delta 波的频率小于每秒 3 个周期。这些波通常仅在您睡着时或幼儿中发现。
Theta waves have a frequency of 4 to 7 cycles per second. These waves are normally found only when you are asleep or in young children. θ 波的频率为每秒 4 到 7 个周期。这些波通常仅在您睡着时或幼儿中发现。
Electroencephalogram (EEG) 脑电图 （EEG）
Normal 正常
In adults who are awake, the EEG shows mostly alpha waves and beta waves. 在清醒的成年人中，脑电图主要显示 α 波和 β 波。
The two sides of the brain show similar patterns of electrical activity. 大脑的两侧表现出相似的电活动模式。
There are no abnormal bursts of electrical activity and no slow brain waves on the EEG tracing. 脑电图描记没有异常的电活动爆发，也没有缓慢的脑电波。
If flashing lights (photic stimulation) are used during the test, one area of the brain (the occipital region) may have a brief response after each flash of light, but the brain waves are normal. 如果在测试过程中使用闪光灯（光刺激），则每次闪光后，大脑的一个区域（枕部区域）可能会有短暂的反应，但脑电波是正常的。
Abnormal 异常
The two sides of the brain show different patterns of electrical activity. This may mean a problem in one area or side of the brain is present. 大脑的两侧表现出不同的电活动模式。这可能意味着大脑的某个区域或一侧存在问题。
Normal In adults who are awake, the EEG shows mostly alpha waves and beta waves.
The two sides of the brain show similar patterns of electrical activity.
There are no abnormal bursts of electrical activity and no slow brain waves on the EEG tracing.
If flashing lights (photic stimulation) are used during the test, one area of the brain (the occipital region) may have a brief response after each flash of light, but the brain waves are normal.
Abnormal The two sides of the brain show different patterns of electrical activity. This may mean a problem in one area or side of the brain is present.| Normal | In adults who are awake, the EEG shows mostly alpha waves and beta waves. |
| :--- | :--- |
| | The two sides of the brain show similar patterns of electrical activity. |
| | There are no abnormal bursts of electrical activity and no slow brain waves on the EEG tracing. |
| | If flashing lights (photic stimulation) are used during the test, one area of the brain (the occipital region) may have a brief response after each flash of light, but the brain waves are normal. |
| Abnormal | The two sides of the brain show different patterns of electrical activity. This may mean a problem in one area or side of the brain is present. |
Abnormal 异常
The EEG shows sudden bursts of electrical activity（spikes）or sudden slowing of brain waves in the brain．These changes may be caused by a brain tumor，infection， injury，stroke，or epilepsy．When a person has epilepsy，the location and exact pattern of the abnormal brain waves may help show what type of epilepsy or seizures the person has．Keep in mind that in many people with epilepsy，the EEG may appear completely normal between seizures．An EEG by itself may not diagnose or rule out epilepsy or a seizure problem． 脑电图显示脑电活动的突然爆发（尖峰）或脑电波突然减慢。这些变化可能是由脑肿瘤、感染、损伤、中风或癫痫引起的。当一个人患有癫痫时，异常脑电波的位置和确切模式可能有助于显示该人患有哪种类型的癫痫或癫痫发作。请记住，在许多癫痫患者中，脑电图在两次发作之间可能看起来完全正常。脑电图本身可能不是诊断或排除癫痫或癫痫发作问题。
The EEG records changes in the brain waves that may not be in just one area of the brain．A problem affecting the entire brain－such as drug intoxication，infections （encephalitis），or metabolic disorders（such as diabetic ketoacidosis）that change the chemical balance in the body，including the brain－may cause these kinds of changes． 影响整个大脑的问题 - 如药物中毒、感染（脑炎）或代谢紊乱（如糖尿病酮症酸中毒）改变体内的化学平衡，包括大脑 - 可能导致这些类型的变化。
The EEG shows delta waves or too many theta waves in adults who are awake．These results may mean brain injury or a brain illness is present．Some medicines can also cause this． 脑电图显示清醒的成年人有 δ 波或过多的 θ 波。这些结果可能意味着存在脑损伤或脑部疾病。一些药物也可能导致这种情况。
The EEG shows no electrical activity in the brain（a＂flat＂or＂straight－line＂EEG）． This means that brain function has stopped，which is usually caused by lack of oxygen or blood flow inside the brain．This may happen when a person has been in a coma．In some cases，severe drug－induced sedation can cause a flat EEG． 脑电图显示大脑中没有电活动（“平坦”或“直线”脑电图）。这意味着大脑功能已经停止，这通常是由于大脑内部缺氧或血流不足引起的。这可能发生在一个人处于 coma.In 在某些情况下，严重的药物诱导镇静会导致平坦的脑电图。
Abnormal The EEG shows sudden bursts of electrical activity（spikes）or sudden slowing of brain waves in the brain．These changes may be caused by a brain tumor，infection， injury，stroke，or epilepsy．When a person has epilepsy，the location and exact pattern of the abnormal brain waves may help show what type of epilepsy or seizures the person has．Keep in mind that in many people with epilepsy，the EEG may appear completely normal between seizures．An EEG by itself may not diagnose or rule out epilepsy or a seizure problem．
The EEG records changes in the brain waves that may not be in just one area of the brain．A problem affecting the entire brain－such as drug intoxication，infections （encephalitis），or metabolic disorders（such as diabetic ketoacidosis）that change the chemical balance in the body，including the brain－may cause these kinds of changes．
The EEG shows delta waves or too many theta waves in adults who are awake．These results may mean brain injury or a brain illness is present．Some medicines can also cause this．
The EEG shows no electrical activity in the brain（a＂flat＂or＂straight－line＂EEG）． This means that brain function has stopped，which is usually caused by lack of oxygen or blood flow inside the brain．This may happen when a person has been in a coma．In some cases，severe drug－induced sedation can cause a flat EEG．| Abnormal | The EEG shows sudden bursts of electrical activity（spikes）or sudden slowing of brain waves in the brain．These changes may be caused by a brain tumor，infection， injury，stroke，or epilepsy．When a person has epilepsy，the location and exact pattern of the abnormal brain waves may help show what type of epilepsy or seizures the person has．Keep in mind that in many people with epilepsy，the EEG may appear completely normal between seizures．An EEG by itself may not diagnose or rule out epilepsy or a seizure problem． |
| :--- | :--- |
| | The EEG records changes in the brain waves that may not be in just one area of the brain．A problem affecting the entire brain－such as drug intoxication，infections （encephalitis），or metabolic disorders（such as diabetic ketoacidosis）that change the chemical balance in the body，including the brain－may cause these kinds of changes． |
| | The EEG shows delta waves or too many theta waves in adults who are awake．These results may mean brain injury or a brain illness is present．Some medicines can also cause this． |
| | The EEG shows no electrical activity in the brain（a＂flat＂or＂straight－line＂EEG）． This means that brain function has stopped，which is usually caused by lack of oxygen or blood flow inside the brain．This may happen when a person has been in a coma．In some cases，severe drug－induced sedation can cause a flat EEG． |
EEG is a useful test to help diagnose epilepsy．However，a normal result does not rule out epilepsy．Many people with epilepsy have a normal result．This is because an EEG only shows the electrical activity of the brain when the test is done．With many types of epilepsy，you only have abnormal electrical activity during a seizure．For the rest of the time，the pattern is normal． 脑电图是帮助诊断癫痫的有用检查。但是，正常的结果并不能排除癫痫。许多癫痫患者的检查结果正常。这是因为脑电图只显示检查完成时大脑的电活动。对于许多类型的癫痫，您只在癫痫发作期间出现异常电活动。其余时间，模式是正常的。
Ambulatory EEG may be advised in cases where the diagnosis is not clear．It uses a portable EEG machine that records the brain＇s electrical activity when you are going about your normal activities． 在诊断不 clear.It 的情况下，建议使用动态脑电图，以便在您进行正常活动时使用便携式脑电图机记录大脑的电活动。
1．Electroencephalography（EEG）is the recording of electrical activity along the scalp produced by the firing of neurons within the brain． 1.脑电图 （EEG） 是由大脑内神经元放电产生的沿头皮的电活动的记录。
脑电图沿颅外头皮记录大脑内部神经元放电所产生的电行为。
2．In clinical contexts，EEG refers to the recording of the brain＇s spontaneous electrical activity over a short period of time，usually 20-4020-40 minutes，as recorded from multiple electrodes placed on the scalp． 2.In 临床背景下，脑电图是指在短时间内（通常是 20-4020-40 几分钟）记录大脑的自发电活动，由放置在头皮上的多个电极记录下来。
3．The brain normally produces tiny electrical signals that come from the brain cells and nerves that send messages to each other． 3.大脑通常会产生来自脑细胞和神经的微小电信号，这些电信号相互发送信息。
大脑细胞和神经相互传递信息时，大脑产生微小的电信号。
4．If flashing lights（photic stimulation）are used during the test，one area of the brain（the occipital region）may have a brief response after each flash of light，but the brain waves are normal． 4.如果在测试过程中使用闪光灯（光刺激），每次闪光后，大脑的一个区域（枕骨区域）可能会有短暂的反应，但脑电波是正常的。
I．In pairs or small groups，discuss the questions． I.In 两人或小组，讨论问题。
1．What are the clinical uses of EEG？ 1.脑电图的临床用途有哪些？
2．What do you think ECG and EEG have in common？ 2.您认为心电图和脑电图有什么共同点？
3．What is stroboscopic stimulation？Why is it sometimes used in EEG test？ 3.什么是频闪刺激，为什么有时用于脑电图测试？
4．What does it represent if the two sides of the brain show different patterns of electrical activity？ 4.如果大脑的两侧表现出不同的电活动模式，那代表什么？
II．Choose the best answer． II.选择最佳答案。
1．The invention of the qquad\qquad allowed scientists to study sleep in ways that were not previously possible． 1. 发明 qquad\qquad 使科学家能够以以前不可能的方式研究睡眠。
A．ECG A.心电图
B．EEG B.脑电图
C．EKG 心电图
D．MRI D.磁共振成像
2. qquad\qquad is the recording of electrical activity along the scalp produced by the firing of neurons within the brain. 2. qquad\qquad 是由大脑内神经元的放电产生的沿头皮的电活动的记录。
A. ECG A. 心电图
B. EEG B. 脑电图
C. EKG C. 心电图
D. MRI D. 磁共振成像
3. In neurology, the main diagnostic application of EEG is in the case of qquad\qquad . 3. 在神经学中，脑电图的主要诊断应用是 qquad\qquad 。
A. epilepsy A. 癫痫
B. diabetic B. 糖尿病
C. coma C. 吃
D. Infection D. 感染
4. What waves are normally found when you are alert? 4. 当您保持警觉时，通常会发现哪些波？
A. Alpha
B. Beta
C. Delta
D. Theta D. θ
5. What waves are present only in the waking state when your eyes are closed but you are mentally alert? 5. 哪些波只在清醒状态下闭着眼睛但精神上很警觉时出现？
A. Alpha
B. Beta
C. Delta
D.Theta
6. Which of the following is true about EEG? 6. 以下关于脑电图的哪一项是正确的？
A. It is a kind of electroshock 一个。这是一种电击
B. It is a kind of electroconvulsive therapy B.这是一种电休克疗法
C. It uses electrical current to pass through the patient’s body C. 它使用电流通过患者的身体
D. It records the electrical activity of brain D. 它记录大脑的电活动
7. Which of the following statement is true about the EEG results? 7. 以下关于脑电图结果的陈述中哪一项是正确的？
A. If flashing lights (photic stimulation) are used during the test, one area of the brain may show brief abnormal waves 一个。如果在测试期间使用闪光灯（光刺激），大脑的一个区域可能会出现短暂的异常波
B. In adults who are awake, the EEG shows mostly beta waves and delta waves B.在清醒的成年人中，脑电图主要显示 β 波和 δ 波
C. Different patterns of electrical activity between the two sides of the brain may mean a problem in one area or side of the brain C. 大脑两侧之间的电活动模式不同可能意味着大脑的一个区域或一侧存在问题
D. A normal result can rule out epilepsy D. 正常结果可排除癫痫
8. Why are flashing lights sometimes used during an EEG test? 8. 为什么在脑电图测试期间有时会使用闪光灯？
A. Because photic stimulation might trigger a seizure, helping the doctor to diagnose 一个。因为光刺激可能会引发癫痫发作，有助于医生诊断
B. Because the brain waves would show some abnormalities B.因为脑电波会显示一些异常
C. Because it may help to illuminate the dark areas of the brain C. 因为它可能有助于照亮大脑的黑暗区域
D. Because it is used to measure the brain’s responding time to the flashing D. 因为它是用来测量大脑对闪烁的反应时间的
9．If the doctor thinks that a person has epilepsy but the EEG is normal，the technologist running the EEG test may have the person to do a couple of things，except for qquad\qquad ． 9.如果医生认为一个人患有癫痫，但脑电图正常，进行脑电图测试的技术人员可能会让这个人做几件事，除了。 qquad\qquad
A．looking at a flashing light A.看着闪烁的灯光
B．breathing fast and deeply B.呼吸急促而深沉
C．sleeping C.睡眠
D．running D.运行
10．EEG is used to diagnose the following health conditions except for qquad\qquad ． 10.脑电图用于诊断以下健康状况 qquad\qquad ，但 除外。
A．abnormal changes in body chemistry that affect the brain A.影响大脑的身体化学异常变化
B．alzheimer＇s disease B.阿尔茨海默病
C．brain tumors C.脑肿瘤
D．intelligence D.智能
III．In pairs，discuss and write definitions for the following terms from the text．You might use the internet to help you． III.In 成对，讨论并写下文本中以下术语的定义。您可以使用互联网来帮助您。
IV．Translate the following sentences into Chinese． IV.将以下句子翻译成中文。
1．In neurology，the main diagnostic application of EEG is in the case of epilepsy，as epileptic activity can create clear abnormalities on a standard EEG study． 1.In 神经学中，脑电图的主要诊断应用是在癫痫的情况下，因为癫痫活动可以在标准脑电图研究中产生明显的异常。
2．The EEG technologist will attach several small electrodes to your scalp，using a sticky paste to hold the electrodes in place． 2.脑电图技师会在您的头皮上贴上几个小电极，使用粘性糊状物将电极固定到位。
3．Certain conditions，such as seizures，can be seen by the changes in the normal pattern of the brain＇s electrical activity． 3.某些情况，例如癫痫发作，可以通过大脑电活动正常模式的变化来看到。
4．When a person has epilepsy，the location and exact pattern of the abnormal brain waves may help show what type of epilepsy or seizures the person has． 4.当一个人患有癫痫时，异常脑电波的位置和确切模式可能有助于显示该人患有哪种类型的癫痫或癫痫发作。
V．Read and complete the text using the words below． V.使用以下单词阅读并完成文本。
brain waves transplants epilepsy strokes brain death electrodes 脑电波移植 癫痫 中风 脑死亡电极
An electroencephalogram（EEG）is a graphic（vivid）picture of the electrical activity 脑电图 （EEG） 是电活动的图形（生动）图片
of the brain. An EEG is made by placing qquad\qquad (1) (small terminals which conduct an electrical current) on the subject’s scalp and connecting the electrode wires to a machine known as an electroencephalograph. The electroencephalograph then records the patterns of qquad\qquad (2) (rhythmic changes in the electric impulses of the brain.) 大脑。脑电图是通过将 qquad\qquad （1）（传导电流的小端子）放在受试者的头皮上并将电极线连接到称为脑电图仪的机器上制成的。然后脑电图仪记录 （2） 的 qquad\qquad 模式（大脑电脉冲的节奏变化）。
EEGs are used to diagnose qquad\qquad (3) (a disorder marked by severe seizures or convulsions), brain tumors, qquad\qquad (4) , and other neurological (nervous system) conditions. These conditions are characterized by distinctive, abnormal patterns of brain waves. EEGs are also used in investigating psychiatric disorders, such as schizophrenia (a psychiatric condition in which a person’s sense of reality is severely distorted). In addition, EEGs help in defining qquad\qquad (5) (the measurable end of brain activity). This diagnosis is necessary before the donation of organs for surgical qquad\qquad (6) . 脑电图用于诊断 qquad\qquad （3）（一种以严重癫痫发作或抽搐为特征的疾病）、脑肿瘤、 qquad\qquad （4） 和其他神经系统（神经系统）疾病。这些疾病的特点是脑电波的独特、异常模式。脑电图还用于调查精神疾病，例如精神分裂症（一种人的现实感被严重扭曲的精神疾病）。此外，脑电图有助于定义 qquad\qquad （5）（大脑活动的可测量终点）。在捐献器官进行手术 qquad\qquad 之前，这种诊断是必要的 （6） 。
VI. Read the text and complete the tasks. VI. 阅读文本并完成任务。
1. Read and complete the text using the words below. 1. 使用以下单词阅读并完成文本。
Hans Berger (1873-1941) was born in Germany. He decided to measure the brain’s electrical qquad\qquad (1) in the hope that the physiological record would provide insight into mental qquad\qquad (2) . 汉斯·伯格 （1873-1941） 出生于德国。他决定测量大脑的电 qquad\qquad （1），希望生理记录能提供对心理 qquad\qquad （2） 的洞察。
Berger began his search for the human EEG by experimenting with dogs. Berger 通过在狗身上做实验开始寻找人类脑电图。
He moved on to humans and started placing needle 他转向人类并开始放置针头 qquad\qquad (3) under the scalp of patients who had lost some of their skull bones in surgery. It was while working with one of these patients that Berger recorded the first human EEG in qquad\qquad （3） 在手术中失去部分颅骨的患者的头皮下。正是在与其中一名患者一起工作时，Berger 记录了第一个人类脑电图 1924. At first, he was uncertain whether the oscillations (changes or variations) he had recorded originated in the brain. It was not until after he had conducted many other qquad\qquad (4) that he published his first paper on the human electroencephalogram in 1929. 1924. 起初，他不确定他记录的振荡（变化或变化）是否起源于大脑。直到他进行了许多其他 qquad\qquad 研究 （4） 之后，他才在 1929 年发表了他的第一篇关于人体脑电图的论文。
The initial reaction of others to Berger＇s work was one of qquad\qquad （5） ．The scientific world doubted whether the workings of an organ as complex as the brain could be recorded through the qquad\qquad （6） ．Berger did not achieve an international reputation until 1934．It was then that Edgar Douglas Adrian（1889－1977），a renowned English qquad\qquad （7） （one who studies the functions of the nervous system），confirmed Berger＇s findings．Hans Berger thus earned the recognition of＂Father of Electroencephalography．＂ 其他人对伯杰工作的第一反应是 qquad\qquad （5） .科学界怀疑是否可以通过 qquad\qquad （6） 来记录像大脑这样复杂的器官的运作。伯杰直到那时埃德加·道格拉斯·阿德里安（1889-1977 qquad\qquad ）（一位研究神经系统功能的人）证实了伯杰的发现，才 1934.It 获得国际声誉。汉斯·伯杰因此赢得了“父亲脑电图。
2．Discuss these questions in pairs or small groups． 2.两人一组或以小组形式讨论这些问题。
（1）How long had passed before Berger＇s findings were accepted by the scientific world？ （1）Berger 的发现被科学界接受过了多久？
（2）What does Berger＇s career reveal about the work of a scientific researcher？ （2）Berger 的职业生涯揭示了科学研究人员的工作的哪些方面？
Project 3
Medical Ultrasonic Instrument 项目 3
医用超声仪
Learning Objectives 学习目标
After studyling project 3 , you should be able to: 完成项目 3 后，您应该能够：
Facquire a general knowledge of the development of ultrasonic instrument F 获得超声波仪器发展的一般知识
2.get acquainted with the working principles of ultrasonic instrument 2.熟悉超声波仪器的工作原理
3: grasp the professional terms about ultrasonic instrument 3：掌握超声仪器的专业术语
4, understand B-mode ultrasound, a 2-D ultrasound imaging 4、懂 B 型超声，一维超声成像
5. become familiar with the new development of ultrasound, such as 3-D ultrasound imaging, and Doppler ultrasound 5. 熟悉超声的新发展，如三维超声成像、多普勒超声等
During the past decade, ultrasonic medical diagnostic instruments have advanced significantly as a result of the resourceful application of electronic-system and acoustictransducer designs to the problem of noninvasive information acquisition from clinical patients. 在过去的十年中，由于电子系统和声学换能器设计在临床患者无创信息获取问题上的资源应用，超声医疗诊断仪器取得了显着进步。
Section 1 Ultrasonic Instrument 第一节 超声波仪器
Condial 拨
Discuss the following questions in pairs or small groups． 两人一组或分成小组讨论以下问题。
1．What methods do bats use to navigate or hunt？ 1.蝙蝠用什么方法导航或捕食？
2．What is ultrasound？ 2.什么是超声波检查？
3．What are the common points between ultrasound wave and audible sound？ 3.超声波和可听声音有什么共同点？
4．What is the difference between ultrasound and audible sound waves？ 4.超声波和可听声波有什么区别？
5．List some of the uses of ultrasound in medical and industrial fields． 5.列出超声在医疗和工业领域的一些用途。
Ultrasound 超声波
Comparable to some other animals on our planet，bats use other methods instead sight in order to navigate or hunt．They are able to＂see＂in the dark by sending out sound waves that bounce back to the bats＇ears from objects such as fruit on trees and flying insect prey．Bats can hear high－frequency sounds that the bats make continually while flying．Frequency is how fast an object vibrates and sound vibrates in waves．The vibrations are measured in Hertz． One Hertz (1Hz)(1 \mathrm{~Hz}) is equivalent to one vibration in a second．Humans can hear from 20 Hz to 20 kHz ．Anything higher is called ultrasound or ultrasonic sound．The reason that bats use ultrasound is because it has such a high frequency and it has a low diffraction or it bends less． The frequencies of bats are different in many books found．In one source like the encyclopedia it says that the frequency is 120 kHz ．While in another it says 100 kHz ．The truth is it ranges because when the bat makes a sound it isn＇t of the same frequency all the time． 与我们星球上的其他一些动物相比，蝙蝠使用其他方法而不是视觉来导航或狩猎。它们能够通过发出声波在黑暗中“看到”，这些声波从树上的水果和飞行的昆虫猎物等物体反弹回蝙蝠的耳朵。蝙蝠可以听到蝙蝠在飞行时不断发出的高频声音。频率是物体振动的速度，声音是波振动的速度。振动是测量的以赫兹为单位。一赫兹 (1Hz)(1 \mathrm{~Hz}) 相当于一秒钟的一次振动。人类可以听到 20 Hz 到 20 kHz 的声音。任何更高的都被称为超声波或超声波。蝙蝠使用超声波的原因是因为它的频率如此之高，而且衍射率低，或者弯曲得更少。蝙蝠的频率在许多书籍中都有所不同，found.In 一个来源，比如百科全书，它说频率是 120 kHz .而在另一个版本中它说 100 kHz .事实是它的范围，因为当蝙蝠发出声音时，它并不总是处于相同的频率。
Bats use ultrasound to do a couple of things like to determine the direction and distance of objects in the area，to fly in complete darkness，swoop down and snatch insects without warning and hover right above water level to get a drink． 蝙蝠使用超声波做一些事情，比如确定该地区物体的方向和距离，在完全黑暗中飞行，毫无警告地俯冲下来抢夺昆虫，并在水面上盘旋以获得饮料。
The method of doing such tasks is called echolocation．The echolocation or biosonar is currently a simpler way for robots to perceive shapes than pattern recognition programs and is much more applicable in areas without the needed light． 执行此类任务的方法称为回声定位。回声定位或生物声纳目前是机器人感知形状的一种比模式识别程序更简单的方法，并且更适用于没有所需光线的区域。
＂We aim to understand the echolocation process that bats have evolved over millennia， “我们的目标是了解蝙蝠几千年来进化的回声定位过程，
and employ similar signals and techniques in engineering systems. We are currently looking to apply these methods to positioning of robotic vehicles, which are used for structural testing. This will provide enhanced information on the robots’ locations, and hence the location of any structural flaws they may detect", said researcher Simon Whiteley from the Centre for Ultrasonic Engineering at the University of Strathclyde. 并在工程系统中采用类似的信号和技术。我们目前正在寻求将这些方法应用于机器人车辆的定位，用于结构测试。这将提供有关机器人位置的增强信息，从而提供它们可能检测到的任何结构缺陷的位置“，斯特拉斯克莱德大学超声工程中心的研究员 Simon Whiteley 说。
Frequency of Bat Sonar 蝙蝠声纳的频率
Whiteley and his colleagues recorded the echolocation calls of six Egyptian fruit bats that were mounted with miniature wireless microphone sensor. The bats generate these calls with “clicks” from their tongues that fill their surroundings with acoustic energy. The pace of the return of the sound waves sketches the dimensions of the bats’ environment and lets them zip around even when lighting is quite poor. Whiteley 和他的同事记录了六只埃及果蝠的回声定位呼叫，这些果蝠安装了微型无线麦克风传感器。蝙蝠通过舌头发出的“咔哒”声来产生这些叫声，这些声音使周围环境充满声能。声波返回的速度勾勒出蝙蝠环境的尺寸，即使在光线很差的情况下，它们也能四处飞驰。
During echolocation, some bats are known to use a natural acoustic gain control. This allows them to emit high-intensity calls without deafening themselves, and then to hear the weak echoes returning from surrounding objects. We as humans can hear many things, from the giant truck driving by to the writing of a pen. The few sounds we cannot hear are bat sounds. Their frequencies of producing sound is much higher than ours and so we can’t hear it. Few animals can hear ultrasonic waves. Some of the animals that can hear them are dogs, cats, porpoises, rodents, whales, dolphins, seals, sea lions and bats. 在回声定位过程中，已知一些蝙蝠使用自然声学增益控制。这使它们能够在不震耳欲聋的情况下发出高强度的呼叫，然后听到周围物体返回的微弱回声。作为人类，我们可以听到很多东西，从驶过的巨型卡车到笔的书写。我们听不到的少数声音是蝙蝠的声音。它们产生声音的频率比我们高得多，因此我们听不到。很少有动物能听到超声波。一些可以听到它们的动物是狗、猫、鼠海豚、啮齿动物、鲸鱼、海豚、海豹、海狮和蝙蝠。
Vocabulary Help 词汇帮助
diffraction［dilfrakj［n］ 衍射[dilfrakj[n]
n．衍射
echolocation［ekeuleu＇keifn］ 回声定位[ekeuleu'keifn]
n．回声定位
biosonar［bi：euzn＇nor］ 生物声纳[BI：EUZN'nor]
n．生物声纳
pattern recognition programme 模式识别程序
模式识别程序，图像识别程序
acoustic energy 声能
声能
gain control 增益控制
增益控制
diffraction［dilfrakj［n］ n．衍射
echolocation［ekeuleu＇keifn］ n．回声定位
biosonar［bi：euzn＇nor］ n．生物声纳
pattern recognition programme 模式识别程序，图像识别程序
acoustic energy 声能
gain control 增益控制| diffraction［dilfrakj［n］ | n．衍射 |
| :--- | :--- |
| echolocation［ekeuleu＇keifn］ | n．回声定位 |
| biosonar［bi：euzn＇nor］ | n．生物声纳 |
| pattern recognition programme | 模式识别程序，图像识别程序 |
| acoustic energy | 声能 |
| gain control | 增益控制 |
TGRT TGRT 系列
Ultrasonic Instrument 超声波仪器
Ultrasound is sound with a frequency greater than the upper limit of human hearing（greater than 20 kHz ）． 超声波是频率大于人类听觉上限（大于 20 kHz）的声音。
Diagnostic sonography（ultrasonography）is an ultrasound－based diagnostic imaging technique used for visualizing subcutaneous body structures including tendons，muscles， joints，vessels and internal organs for possible pathology or lesions．Obstetric sonography is commonly used during pregnancy and is widely recognized by the public． 超声诊断（ultrasonography）是一种基于超声的诊断成像技术，用于可视化皮下身体结构，包括肌腱、肌肉、关节、血管和内脏器官，以发现可能的病理或病变。
In physics，the term＂ultrasound＂applies to all sound waves with a frequency above the audible range of normal human hearing，about 20 kHz ．The frequencies used in diagnostic ultrasound are typically between 2 and 18 MHz ，though frequencies up to 50－100 megahertz have been used experimentally in a technique known as biomicroscopy in special regions， such as the anterior chamber of the eye．The choice of frequency is a trade－off between spatial resolution of the image and imaging depth：lower frequencies produce less resolution but image deeper into the body．Higher frequency sound waves have a smaller wavelength and thus are capable of reflecting or scattering from smaller structures．Higher frequency sound waves also have a larger attenuation coefficient and thus are more readily absorbed in tissue，limiting the depth of penetration of the sound wave into the body． 在物理学中，术语“超声波”适用于频率高于正常人类听觉范围（约 20 kHz）的所有声波。诊断超声中使用的频率通常在 2 到 18 MHz 之间，尽管高达 50-100 兆赫兹的频率已被实验用于特殊区域（如眼睛前房）的生物显微镜技术中。频率的选择是图像的空间分辨率和成像之间的权衡深度：较低的频率产生的分辨率较低，但图像深入身体。高频声波的波长较小，因此能够从较小的结构反射或散射。高频声波也具有较大的衰减系数，因此更容易被组织吸收，限制了声波穿透体内的深度。
Sonography（ultrasonography）is widely used in medicine．It accounts for one in four imaging studies and this proportion is increasing．It is possible to perform both diagnosis and therapeutic procedures，using ultrasound to guide interventional procedures（for instance 超声检查（ultrasonography）广泛用于 medicine.It 占影像学研究的四分之一，这一比例 increasing.It 可以执行诊断和治疗程序，使用超声指导介入程序（例如
biopsies or drainage of fluid collections). Sonographers typically use a hand-held probe (called a transducer) that is placed directly on and moved over the patient. Increasingly, clinicians are using ultrasound in their office and hospital practices, for efficient, low-cost, dynamic diagnostic imaging that facilitates treatment planning while avoiding any radiation exposure. 活检或积液引流）。超声医师通常使用手持式探头（称为换能器），该探头直接放在患者身上并在患者上方移动。临床医生越来越多地在他们的办公室和医院实践中使用超声，以实现高效、低成本、动态的诊断成像，从而促进治疗计划，同时避免任何辐射暴露。
Sonography is effective for imaging soft tissues of the body. Superficial structures such as muscles, tendons, testes, breast, thyroid and parathyroid glands, and the neonatal brain are imaged at a higher frequency ( 7-18MHz7-18 \mathrm{MHz} ), which provides better axial and lateral resolution. Deeper structures such as liver and kidney are imaged at a lower frequency 1-6MHz1-6 \mathrm{MHz} with lower axial and lateral resolution but greater penetration. 超声检查对身体软组织成像有效。肌肉、肌腱、睾丸、乳房、甲状腺和甲状旁腺以及新生儿大脑等浅表结构以更高的频率成像 （ 7-18MHz7-18 \mathrm{MHz} ），从而提供更好的轴向和横向分辨率。肝脏和肾脏等较深的结构以较低的频率 1-6MHz1-6 \mathrm{MHz} 成像，具有较低的轴向和横向分辨率，但穿透力较大。
Medical Sonographic Instrument 医用超声仪
A basic ultrasound machine has the following parts: 基本的超声机有以下部分：
Transducer probe-probe that sends and receives the sound waves. 换能器探头 - 发送和接收声波的探头。
Central processing unit (CPU)-computer that does all of the calculations and contains the electrical power supplies for itself and the transducer probe. 中央处理器 （CPU） - 执行所有计算并包含自身和传感器探头的电源的计算机。
Transducer pulse controls-changes the amplitude, frequency and duration of the pulses emitted from the transducer probe. 传感器脉冲控制 - 改变传感器探头发射的脉冲的幅度、频率和持续时间。
Display-displays the image from the ultrasound data processed by the CPU 显示 - 显示 CPU 处理的超声数据中的图像
Keyboard/cursor-inputs data and takes measurements from the display. 键盘/光标输入数据并从显示屏上进行测量。
Disk storage device（hard，floppy，CD）－stores the acquired images． 磁盘存储设备（硬核、软盘、CD）-存储采集的图像。
Printer－prints the image from the displayed data． 从显示的数据中打印图像。
The transducer probe is the main part of the ultrasound machine．The transducer probe makes the sound waves and receives the echoes．It is，so to speak，the mouth and ears of the ultrasound machine．The transducer probe generates and receives sound waves using a principle called the piezoelectric（pressure electricity）effect，which was discovered by Pierre and Jacques Curie in 1880．In the probe，there are one or more quartz crystals called piezoelectric crystals． When an electric current is applied to these crystals，they change shape rapidly．The rapid shape changes，or vibrations，of the crystals produce sound waves that travel outward．Conversely， when sound or pressure waves hit the crystals，they emit electrical currents．Therefore，the same crystals can be used to send and receive sound waves．The probe also has a sound absorbing substance to eliminate back reflections from the probe itself，and an acoustic lens to help focus the emitted sound waves． 换能器探头是超声机的主要部件，换能器探头产生声波并接收 echoes.It，可以说是超声机的嘴巴和耳朵。换能器探头利用一种称为压电（压力电）效应的原理产生和接收声波，该原理是由皮埃尔和雅克·居里在 1880.In 探头时发现的，有一种或多种石英晶体称为压电晶体。当施加电流时对于这些晶体，它们会迅速改变形状。晶体的快速形状变化或振动会产生向外传播的声波。相反，当声波或压力波撞击晶体时，它们会发出电流。因此，相同的晶体可以用来发送和接收声波。探头还具有吸声物质，用于消除探头本身的背向反射，以及一个声学透镜，以帮助聚焦发射的声波。
Transducer probes come in many shapes and sizes．The shape of the probe determines its field of view，and the frequency of emitted sound waves determines how deep the sound waves penetrate and the resolution of the image．Transducer probes may contain one or more crystal elements；in multiple－element probes，each crystal has its own circuit．Multiple－element probes have the advantage that the ultrasonic beam can be＂steered＂by changing the timing in which each element gets pulsed；steering the beam is especially important for cardiac ultrasound．In addition to probes that can be moved across the surface of the body，some probes are designed to be inserted through various openings of the body（vagina，rectum，esophagus）so that they can get closer to the organ being examined（uterus，prostate gland，stomach）；getting closer to the organ can allow for more detailed views． 探头的形状和尺寸多种多样。探头的形状决定了探头的视场，而发射声波的频率决定了声波穿透的深度和图像的分辨率。探头可以包含一个或多个晶体元件;在多晶片探头中，每个晶体都有自己的电路。多晶片探头的优点是，通过改变每个晶片的脉冲时间，可以“控制”超声波束;控制声束对于心脏 ultrasound.In 尤其重要 除了可以在身体表面移动的探针外，一些探针被设计为通过身体的各种开口（阴道、直肠、食道）插入，以便它们可以更接近被检查的器官（子宫、前列腺、胃）;靠近器官可以允许更详细的视图。
The CPU is the brain of the ultrasound machine．The CPU is basically a computer that contains the microprocessor，memory，amplifiers and power supplies for the microprocessor and transducer probe．The CPU sends electrical currents to the transducer probe to emit sound waves，and also receives the electrical pulses from the probes that were created from the returning echoes．The CPU does all of the calculations involved in processing the data．Once the raw data are processed，the CPU forms the image on the monitor．The CPU can also store the processed data and／or image on disk． CPU 是超声机的大脑。CPU 基本上是一台计算机，其中包含微处理器、内存、放大器和微处理器和传感器探头的电源。CPU 向传感器探头发送电流以发射声波，并接收来自探头的电脉冲，这些电脉冲是从返回的回波中产生的。CPU 执行处理数据所涉及的所有计算。处理完原始数据后，CPU 在监视器上形成图像。CPU 还可以将处理后的数据和/或图像存储在磁盘上。
Transforming the received signal into a digital image may be explained by using a blank 将接收到的信号转换为数字图像可以通过使用空白来解释
spreadsheet as an analogy. First picture a long, flat transducer at the top of the sheet. Send pulses down the “columns” of the spreadsheet (A, B, C, etc.). Listen at each column for any return echoes. When an echo is heard, note how long it took for the echo to return. The longer the wait, the deeper the row ( 1,2,31,2,3, etc.). The strength of the echo determines the brightness setting for that cell (white for a strong echo, black for a weak echo, and varying shades of grey for everything in between.) When all the echoes are recorded on the sheet, we have a greyscale image. 电子表格作为类比。首先在板材顶部画一个长而扁平的换能器。将脉冲发送到电子表格的 “列” （A、B、C 等）。侦听每列是否有任何返回回声。听到回声时，请记下回声返回所花费的时间。等待时间越长，行 （ 1,2,31,2,3 等） 就越深。残影的强度决定了该单元的亮度设置（白色表示强残影，黑色表示弱残影，灰色阴影不同，介于两者之间）。当所有回波都记录在工作表上时，我们得到了一个灰度图像。
The transducer pulse controls allow the operator, called the ultrasonographer, to set and change the frequency and duration of the ultrasound pulses, as well as the scan mode of the machine. The commands from the operator are translated into changing electric currents that are applied to the piezoelectric crystals in the transducer probe. 换能器脉冲控制允许作员（称为超声医师）设置和更改超声脉冲的频率和持续时间，以及机器的扫描模式。作员的命令被转换为变化的电流，这些电流施加到传感器探头中的压电晶体上。
In ultrasound, the following events happen: 在超声检查中，会发生以下事件：
The ultrasound machine transmits high-frequency sound pulses into your body using a probe. 超声波机使用探头将高频声音脉冲传输到您的体内。
The sound waves travel into your body and hit a boundary between tissues (e.g. between fluid and soft tissue, soft tissue and bone). 声波传播到您的身体并撞击组织之间的边界（例如，液体和软组织、软组织和骨骼之间）。
Some of the sound waves get back to the probe, while some travel on further until they reach another boundary and get reflected. 一些声波回到探头，而另一些声波则继续传播，直到它们到达另一个边界并被反射。
The reflected waves are picked up by the probe and relayed to the machine. 反射波被探头拾取并传递到机器。
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（GHTF）was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems．
1924. At first, he was uncertain whether the oscillations (changes or variations) he had recorded originated in the brain. It was not until after he had conducted many other 
