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BME 153 Fall 2023 HW1 Study Guide
HW1
Study Guide
1.
How are medical devices classified by the FDA in the US?
2.
Provide examples of Class I medical devices.
3.
Provide examples of Class II medical devices.
4.
Provide examples of Class III medical devices.
5.
What is the regulatory pathway for Class II medical devices?
6.
What is 510(k)? 7.
What is PMA?
8.
Name the regulatory pathway for each of the medical device:
a.
A new continuous blood glucose monitor
b.
A new vein endoprosthesis that has a minor design change from its FDA-approved predicate product.
c.
A breast implant with a new type of anti-adhesion coating
9.
Which device in question 8 will most likely require a clinical trial?
10.Explain why randomized trials are usually not required for medical device clinical trials.
11.What are the main study design differences between a device clinical trial and a drug clinical trial?
12.An estimate of _______ % of total hip replacements fail after 15 years.
13.Describe the main differences between a hip replacement and hip resurfacing.
14.What was the main cause that metal-on-metal hip replacement had a higher failure rate and plastic-on-metal hip replacement, despite having the same metallic material?
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Related Questions
2a
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2.
Conduction is function of the environment's humidity and the airflow/exchange next to the skin.
True
False
3.
One of the amendments to Regulation 854 that came into force in 2016 is strengthening and improving requirements
regarding high visibility safety apparel.
True
False
4.
Cold stress is also known as "thermal strain".
True
False
5. Dynamic force presents a greater risk of strain than static force.
True
False
6.
In underground climate, auto compression of air adds 4-60C/km to the wet bulb temperature.
True
False
An industrial machinery gives out 112 dBA of noise 1 m away from the source, which requires double hearing
protection. You are a worker performing work for 8-hrs around the machinery and you are required to wear double
hearing protection. An earplug which has an NRR of 29 dB and an earmuff with an NRR of 31 dB. The suggested
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University of Basrah - College of Engineering
Department of Mechanical Engineering
Subject: Power Plant I
Class: Fourth
Examiner: Dr. Ahmad A. M Alsahlani
Notes: Giving Sketches is compulsory wherever needed (Total Ma
Q1] Answer the following que
Exam: Final-Exam
Date: 11/09/2023
Time: 2 Hours
1- Explain how the Geothermal Energy can be utilized to generate electricity.
2- State the two classifications of energy sources and give three examples for each.
3- State three advantages and three disadvantages of using Gas Turbine Power Plant.
4- What are the reasons that lead to a deviation in the ideal gas turbine cycle?
5- Draw a block diagram for a regenerative Rankin Cycle using one open feed water
heater.
Q2]
A closed cycle gas-turbine power plant has a pressure ratio of 10. The air temperature is
35 C at the compressor inlet and 1127 C at the turbine inlet. The received energy at the Qi
combustion chamber is 794 kJ/kg. Assume the isentropic efficiency of the turbine is
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ii. Identify typical disadvantages
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|1. Knowledge
and
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ii. Identify typical disadvantages
associated with Hydro Power
iv. Identify typical disadvantages
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i. At what point in time will the emission rates be the same?ii. What reduction in emissions results from using the student’s engine?
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bliuzodt to mopolb
9. If machine parts are degreased by means of kerosene as shown in the diagram,
how much kerosene make-up is needed per day? How much kerosene has to enter
the degreasing vat per day? There are about 3 lb of grease per 100 lb of machine
parts, and 60 tons of machine parts are processed each day. Five thousand pounds
of kerosene (the 10% solution) are carried away by the machine parts each day
but drip off and are caught and put back in the degreasing vat. Two hundred
pounds of the 10% solution are lost each day from the vat by evaporation, spillage,
or by being carried away.
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0.Consider the Material Selection Design Problem for the FRAME of a Human Powered Road
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following alternatives based on COST, WEIGHT, STRENGTH, AVAILABILITY,
MANUFACTURABILITY, ASSEMBLY, TEST & MAINTENANCE, ENVIRONMENT
& SUSTAINABILITY, SAFETY & RELIABILITY:
a.Steel
b.Aluminum
c. Titanium
d.Composite- CFRP
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QUESTION 4
1. This question is about the section titled, Airplanes. Which of the following statement is NOT true
according to this reading?
The design known as "winglets" was shown to reduce fuel use by 5%.
How an airplane operates with respect to taxi or take-off has an insignificant impact on the
airplane fuel use.
C
C
Jet biofuel is currently expensive and limited in supply.
The goal of the Carbon Offset and Reduction Scheme of International Aviation (CORSIA) is
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B1
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a. Piston-cylinder parts, Top dead centre TDC, Bottom dead centre BDC, and Clarence volume.
b. Intake vale, Exhaust Valve, Spark plug, Stroke displacement, Bore dimeter.
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A tank containing air is stirred by a paddle wheel.
The work input to the paddle wheels is 2000KJ and the heat transferred to the surrounding from the tank is 6000KJ.
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Q3
(a) The employees involve in maintenance work of the sewerage tank
experience risk of drowning due to either lack of oxygen or swallowing
water. Applying the knowledge of risk at construction sites, write the causal
factors that can cause drown at the sewerage tank maintenance work.
(b)
As a safety officer appointed at your company, you should know that the
main objective of electrical safety is to protect human from electric shock,
fire and burning effect resulted from contact with electricity. Select FIVE
(5) factors to be considered for safe electricity usage at your work place and
support your answer with explanations.
It is known that the chemist is always work with a chemical substances.
Identify and explain the health effects to the body if there is negligence
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13. The amount of heat (Hth, thermal
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= 840 J/(kg °C), Tfinal =50°C, Tinitial =
40°C is:
·Hth = 19*10E(6) Joules.
·Hth = 4.2 * 10E(6) Joules.
%3D
·Hth = 4.2*10E(4)Joules.
%3D
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discharge. If the river flow rate is 1,500 cubic feet per second,
after the discharged water has thoroughly mixed with the river
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directed by a hose to a floor drain),
A curious home owner wonders how much water will be collected in a 12 hour period. He empties the bucket at the start of the
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b. 68.2 kBtu/ft2
c. 73.6 kBtu/ft2
d. 79.4 kBtu/ft2
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