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BMED 2310 > 3/4 Term Test > Flashcards

3/4 Term Test Flashcards

1
Q

antropometric

A

how devices interact with the body

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2
Q

Scientific Management Taylorism

A

Frederick Winslow Taylor

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3
Q

4 Usability Principles

A

Intuitive Familiar Semantically Correct Practical (FIPS)

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4
Q

Intuitive

A

It does what I expect

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5
Q

Familiar

A

works like ones i’ve used before

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6
Q

Semantically Correct

A

form matches function

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7
Q

practical

A

does what I need, when I need it

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8
Q

usability attributes

A 
visibility
mental models
affordances and constraints
mapping
feedback
error (ACEFMMV)
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9
Q

HCD Methods

A

designed to gain empathetic understanding of stakeholders and user needs

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10
Q

user observations

A

watching people gives you clues about what they think and feel

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11
Q

user interviews

A

get feedback on a project

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12
Q

Role playing and co-designing

A

act out the use of your device as various users

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13
Q

prototype vs model vs proof of concept

A

prototype - first full scale and functional form

model - mini representation of something

proof of concept - test part of a design

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14
Q

laser cutter vs water jet

A

same thing but water jet can cut all metal woods and plastic

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15
Q

TRAK Mill vs CNC

A

2axis vs 3 axis

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16
Q

3D printing

A

good to verify scale and fit but not structural

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17
Q

when was the FDA founded

A

1862

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18
Q

how many carcinogens in cigarette

A

70

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19
Q

device definition

A

affect structure of body without chemical reaction or metabolism

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20
Q

which class has the most risk

A

Class 3

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21
Q

class I

A

non life sustaining

failure doesn’t pose risk to life

General controls

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22
Q

class I are exempt from ___

A

premarket notification, 510K

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23
Q

Class II

A

non life sustaining

ex. wheelchair, BP monitor

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24
Q

class II are subjet to __

A

standards and guidance documents

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25
for class II, companies submit __
510K
26
how long does the FDA have to respond to a company for a class II
90 days
27
for class II, the FDA provides __
clearance
28
class III
supports human life failure is life threatening
29
class III requires
clinical trials
30
for each class, how long should you expect to wait after submission until approval is granted
``` class I - 1 month class II - 3-6 months Class III - 18-30 months ```
31
how long is a device valid for once approval is granted form FDA
approval does not expire
32
for a 510K, the device must be
substantially equivalent
33
predicate device
a device previously cleared for commercialization and sales by the FDA via 510k
34
premarket approval (PMA)
apply to class III devices
35
what do PMA demonstrate
demonstrates safety and effectiveness
36
FDA issues approval of __
Device, Its uses, and manufacturing methods
37
how much is PMA submission fee
$310k
38
what qualifies a small business
sales of $30 million or less
39
when must a device go through pre market approval
if a device being submitted is significantly different, relative to pre-1976 device
40
what does a patent do and not do
is gives right to prevent others from making or selling the invention it does not give the owner of the patnet a right to practice the subject covered by the patent
41
why seek a patent
to protect your idea of license your patent for money
42
how many patents are there
1.5 million patents but only 3000 are commercially viable
43
what are the 2 types of patents
utility and deisgn
44
utility patents vs. design patents
structural vs. visual appearance
45
Inventorship
all persons who contributed to the conception of an invention
46
assignor vs asignee
assignor is the inventor assignee is the person or company that has the right to practice or use the specific patent
47
only __ can be named as inventors
individuals (one or more)
48
Time for provisional, nonprovisional, patent issued
provision --> 1 year non-provisional --> 3-5 years patent issued --> 17-20 years
49
typical cost of patent
25K - 150K
50
how long does a copy right last
70 year after authors death
51
the formula for coke and KFC are known as ___
trade secrets
52
part of the patent that really only counts
the claim
53
what does ethics mean
objective analysis about what people ought to do
54
what are morals
codes of conduct of a society
55
what are the two moral norms
beneficence - practice of doing good nonmaleficence - do no harm
56
what is integrity
adherence to moral and ethical principals
57
what is the sunshine act
Part of the ACA that requires all drug and device manufacturers to track and report all payments to hospitals or physicians
58
in terms of tolerances, which is the highest grade and which is the lowest grade
lapping and honing is the highest (grade 4) Milling, drilling, planning are the lowest (13)
59
objective
a feature or behavior that the design should have or exhibit
60
constraint
a limit or restriction on the design's behavior
61
function
a specific thing a device is expected to do
62
means
a way to make a function happen
63
stakeholder
someone with an interest or concern in something
64
Professional code of ethics
1. hold paramount saftey of public 2. perform services only in area of competence 3. issue public statements in objective and truthful manner 4. act for each employer as faithful agents 5. avoid deceptive acts 6. conduct themselves honorable (ACDHPP)
65
cognitive (usability) considerations
how devices communicate their purpose and operation
66
HDC methods
1. lit reviews 2. consumer reports 3. user observations 4. user survey 5. interviews 6. usability study 7. role-playing (CLIRUUU)
67
experience maps
By studying the context of use, you'll have the information needed to map out the user's experience
68
why use personas
a way to compare and establish goals for varying users
69
why use storyboards
tell the story of user experience or explain how a device is intended to work
70
direct vs indirect extrusion
direct - pushes throught a hole indirect - pushes into a cavity
71
compression molding
used to make rubber boots

BMED 2310 (1 decks)

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