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Файл:English Guide for Bio-Medical Engineers. Учебное пособие
.pdf
Министерство образования и науки Российской Федерации
Федеральное государственное бюджетное образовательное учреждение
высшего профессионального образования
«Оренбургский государственный университет»
Е.В. Дмитриева, С.Г. Иванова, Н.С. Сахарова
ENGLISH GUIDE FOR BIO-MEDICAL
ENGINEERS
Рекомендовано Ученым советом федерального государственного бюджетного
образовательного учреждения высшего профессионального образования
"Оренбургский государственный университет" в качестве учебного пособия для
студентов, обучающихся по программам высшего образования по направлению
подготовки 12.03.04 Биотехнические системы и технологии
Оренбург
2015
УДК 811.111:615.47(075.8)
Д 53
Дмитриева, Е.В.
English Guide for Bio-Medical Engineers : учебное пособие / Е.В.
Дмитриева, С.Г. Иванова, Н.С. Сахарова; Оренбургский гос. ун-т. –
Оренбург : ОГУ, 2015. – 120 с.
ISBN 978-5-7410-1280-2
Дмитриева Е.В.,
Иванова С.Г.,
Сахарова Н.С., 2015
ОГУ, 2015
ББК 81.432.1я73+51я73
Д 53
Рецензент – профессор, доктор педагогических наук О.М. Осиянова
ISBN 978-5-7410-1280-2
Учебное пособие состоит из 10 разделов и 4 приложений, в которых
представлены аутентичные тексты биоинженерной тематики на английском языке,
справочный материал. Материалы пособия направлены на развитие навыков
самостоятельной работы, аналитических, переводческих и коммуникативных
умений студентов в области инженерного дела.
Учебное пособие предназначено для студентов 2 курса по направлению
подготовки 12.03.04 Биотехнические системы и технологии, профиль «Инженерное
дело в медико-биологической практике».
УДК 811.111:615.47(075.8)
ББК 81.432.1я73+51я73
2
Содержание
Введение………………………………………………………………………
4
1 Unit1. Regulatory issues for bio-medical engineers.......................................
5
2 Unit 2. Artificial cardiac pacemaker ..............................................................
10
3 Unit 3. Methods of pacing ………………………….....................................
16
4 Unit 4. Pacemaker usage considerations ……………………………............
27
5 Unit 5. Pacemaker maintenance ………………………………………….....
34
6 Unit 6. Other devices with pacemaker function ………………………….....
45
7 Unit 7. History of MRI...............................................................................
53
8 Unit 8. Specialized MRI scans ……………………………………...............
57
9 Unit 9. Methods of Ocular Observation …………………………………….
69
10 Unit 10. Phaco Module ................................................................................
78
Список использованных источников………………………………………
87
Приложение А Работа с текстом…… … …… …… .. .. .. .. .. .. .. .. .. .. ..
88
Приложение B Типы словарей....................................………………….....
95
Приложение C Реферирование и аннотирование……........…………….....
99
Приложение D Эссе.............................................……........…………….....
116
3
Введение
Данное учебное пособие составлено в рамках ООП по дисциплине
«Иностранный язык» и предназначено для обучения студентов чтению, пониманию
оригинальных текстов биоинженерной тематики на английском языке и направлено
на развитие аналитических, переводческих и коммуникативных умений студентов в
области инженерного дела.
Целью пособия является расширение знаний по специальности «Инженерное
дело в медико-биологической практике». Текстовый материал пособия знакомит
студентов с различными видами, техническими характеристиками и условиями
эксплуатациями медицинского оборудования.
Учебное пособие предназначено для студентов 2 курса, по направлению
подготовки 201000 Биотехнические системы и технологии, профиль «Инженерное
дело в медико-биологической практике» (бакалавриат).
Пособие состоит из десяти разделов, каждый из которых включает
аутентичные тексты на английском языке, послетекстовые задания. В пособии
имеется справочник с рекомендациями по написанию рефератов, аннотаций и эссе.
Практическая ценность пособия заключается в наличии аутентичного
материала, системы упражнений на развитие навыков самостоятельной работы с
текстами по специальности с использованием профессиональной терминологии как
в аудитории под контролем преподавателя, так и самостоятельно. Материалы
пособия направлены как на расширение лингвистических, так и профессиональных
знаний средствами английского языка в процессе выполнения заданий.
4
1 Unit 1. Regulatory issues for bio-medical engineers
Text A. 1.1 Regulatory issues for bio-medical engineers
1.1.1 Read and translate text A:
Regulatory issues are of particular concern to a bio-medical engineer; it is among
the most heavily-regulated fields of engineering, and practicing bio-medical engineers
must routinely consult and cooperate with regulatory law attorneys and other experts. The
Food and Drug Administration (FDA) is the principal healthcare regulatory authority in
the United States, having jurisdiction over medical devices, drugs, biologics, and
combination products. The paramount objectives driving policy decisions by the FDA
are safety and efficacy of healthcare products.
In addition, because biomedical engineers often develop devices and technologies
for "consumer" use, such as physical therapy devices (which are also "medical" devices),
these may also be governed in some respects by the Consumer Product Safety
Commission. The greatest hurdles tend to be 510K "clearance" (typically for Class 2
devices) or pre-market "approval" (typically for drugs and class 3 devices).
Figure 1 – Implants (artificial hip joints), are regulated due to the invasive nature of such
devices
Most countries have their own particular mechanisms for regulation, with varying
formulations and degrees of restrictiveness. In most European countries, more discretion
rests with the prescribing doctor, while the regulations chiefly assure that the product
5
operates as expected. In European Union nations, the national governments license
concern efficacy facilitate for-profit develop healthcare
certifying agencies, which are for-profit companies. Technical committees of engineers
write recommendations which incorporate public comments, and these can be adopted as
regulations by the European Union. These recommendations vary by the type of device,
and specify tests for safety and efficacy. Once a prototype has passed the tests at a
certification lab, and that model is being constructed under the control of a certified
quality system, the device is entitled to bear a CE mark, indicating that the device is
believed to be safe and reliable when used as directed.
The different regulatory arrangements sometimes result in particular technologies
being developed first for either the U.S. or in Europe depending on the more favorable
form of regulation. While nations often strive for substantive harmony to facilitate crossnational distribution, philosophical differences about the optimal extent of regulation can
be a hindrance; more restrictive regulations seem appealing on an intuitive level, but
critics decry the trade off cost in terms of slowing access to life-saving developments.
1.1.2 Write the transcription of following words and word-combinations, find out
the meanings:
law attorney, heavily-regulated field, paramount, efficacy, healthcare, hurdle,
clearance, restrictiveness, for-profit company, discretion, cross-national distribution,
hindrance, to decry.
1.1.3 Complete each sentence with a word or phrase from the box:
1) Regulatory issues are of particular … to a bio-medical engineer.
2) The Food and Drug Administration (FDA) is the principal … regulatory authority in
the United States.
3) Bio-medical engineers often … devices and technologies for "consumer" use.
4) In European Union nations, the national governments license certifying agencies,
which are … companies.
6
5) These recommendations vary by the type of device, and specify tests for safety and
… .
6) While nations often strive for substantive harmony to … cross-national distribution,
philosophical differences about the optimal extent of regulation can be a hindrance.
1.1.4 Divide the text into logical parts and entitle them.
Text B. 1.2 RoHS II
1.2.1 Read and translate text B:
Directive 2011/65/EU, better known as RoHS 2 is a recast of legislation originally
introduced in 2002. The original EU legislation “Restrictions of Certain Hazardous
Substances in Electrical and Electronics Devices” (RoHS Directive 2002/95/EC) was
replaced and superseded by 2011/65/EU published in July 2011 and commonly known as
RoHS 2. RoHS seeks to limit the dangerous substances in circulation in electronics
products, in particular toxins and heavy metals, which are subsequently released into the
environment when such devices are recycled.
The scope of RoHS 2 is widened to include products previously excluded, such as
medical devices and industrial equipment. In addition, manufacturers are now obliged to
provide conformity risk assessments and test reports – or explain why they are lacking.
For the first time, not only manufacturers, but also importers and distributors share a
responsibility to ensure Electrical and Electronic Equipment within the scope of RoHS
comply with the hazardous substances limits and have a CE mark on their products.
The Directive has to be transposed by the Member States by January 2, 2013.
1.2.2 Write the transcription of following words and word-combinations, find out
the meanings:
recast of legislation, to supersede, circulation, subsequently, to recycle, conformity risk
assessment, to lack, hazardous substances, to be transposed.
7
1.2.3 Put the phrases in the proper place:
1) Directive 2011/65/EU, better known as RoHS 2 is a originally introduced in
2002. (recast of legislation)
2) RoHS seeks to limit the dangerous substances in circulation in electronics
products, in particular toxins and heavy metals, which are subsequently when such devices
are recycled. (released into the environment)
3) In addition, manufacturers are now conformity risk assessments and test reports –
or explain why they are lacking. (obliged to provide)
4) Equipment within the scope of RoHS comply with and have a CE mark on their
products. (the hazardous substances limits)
5) The scope of RoHS 2 is widened to include products, such as medical devices and
industrial equipment. (previously excluded)
6) The Directive has to be transposed by January 2, 2013. (by the Member States)
1.2.4 Write the abstract/summary of the text.
Text C. 1.3 IEC 60601
1.3.1 Read and translate text C:
The new International Standard IEC 60601 for home healthcare electro-medical
devices defining the requirements for devices is used in the home healthcare environment.
IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a
wide range of home use and point of care medical devices along with other applicable
standards in the IEC 60601 3rd edition series.
The mandatory date for implementation of the EN European version of the standard
is June 1, 2013. The US FDA requires the use of the standard on June 30, 2013, while
Health Canada recently extended the required date from June 2012 to April 2013. The
North American agencies will only require these standards for new device submissions,
8
while the EU will take the more severe approach of requiring all applicable devices being
placed on the market to consider the home healthcare standard. As a result, the time to
design or redesign medical devices to the new standard is now.
1.3.2 Write the transcription of following words and word-combinations, find out
the meanings:
to be incorporated into, verification, point of care , applicable, mandatory date ,
implementation, submission, to be placed on the market.
1.3.3 Write out key words and word combinations from the text.
1.3.4 Say whether the following statements are True or False and correct the false
ones:
1) The new International Standard IEC 60601 for home healthcare electro-medical
devices is used in the hospitals.
2) IEC 60601-1-11 (2010) must now be incorporated into the design and verification
of a wide range of home use.
3) The mandatory date for implementation of the EN European version of the
standard is June 1, 2014.
4) The US FDA requires the use of the standard on June 30, 2013.
5) The South American agencies will only require these standards for new device
submissions.
6) The EU will take the less severe approach of requiring all applicable devices
being placed on the market to consider the home healthcare standard.
9
2 Unit 2. Artificial cardiac pacemaker
Text A. 2.1 Artificial cardiac pacemaker
2.1.1 Read and translate text A:
"Cardiac resynchronization therapy" or "CRT" is considered here. For the device
termed a CRT-D, see Implanted cardiac resynchronization device. For other uses,
see Pacemaker (disambiguation).
Figure 2 – A pacemaker with Figure 3 – An artificial pacemaker
a scale in centimeters with electrode
The body of the device is about 3-4 centimeters long, the electrode measures
between 50 and 60 centimeters (20 to 24 inches). A pacemaker (or artificial pacemaker, so
as not to be confused with the heart's natural pacemaker) is a medical device that uses
electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the
beating of the heart. The primary purpose of a pacemaker is to maintain an adequate heart
rate, either because the heart's native pacemaker is not fast enough, or there is a block in
the heart's electrical conduction system. Modern pacemakers are externally programmable
and allow the cardiologist to select the optimum pacing modes for individual patients.
Some combine a pacemaker and defibrillator in a single implantable device. Others have
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