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86 Cards in this Set
- Front
- Back
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primary operating function
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function that involves user interaction that is either frequently used or related to the safety of the medical device
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usability
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characteristic of the user interface that establishes effectiveness, efficiency, ease of user learning and user satisfaction
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usability engineering
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application of knowledge about human behavior, abilities, limitations, and other characteristics related to the design of tools, devices, systems, tasks, jobs, and environments to achieve adequate usability
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usability engineering file
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set of records and other documents that are produced by the usability engineering process
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user error
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act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user
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List the 3 types of user error.
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slips, lapses, and mistakes
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Application specification includes what categories?
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intended medical indication, intended user profile, intended conditions of use, operating principle, and intended patient population
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List 5 categories of the intended user profile.
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education, knowledge, language, experience, permissible impairments
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List four categories of the intended conditions of use.
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environment, frequency of use, location, mobility
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frequently used functions involves...
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user interaction with medical device only
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slip
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potentially observable as externalized actions-not-as-planned (slips of the tongue, slips of the pen, slips of action)
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lapse
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more covert error forms, largely involving failures of memory, that do not necessarily manifest themselves in actual behavior and can only be apparent to the person who experiences them
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mistake
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deficiency or failure in the judgmental and/or inferential process involved in the selection of an objective whether or not the actions directed by this decision-scheme run according to plan
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Which type(s) of user error?
result from some failure in the execution and/or storage stage of an action sequence, regardless of whether or not the plan that guided them was adequate to achieve its objective |
slips and lapses
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Harm
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physical injury or damage to the health of the people, or damage to the property or the environment
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hazard
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potential source of harm
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hazardous situation
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circumstance in which people, property, or the environment are exposed to one or more hazard(s)
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risk
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combination of the probability of occurrence of harm and the severity of that harm
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severity
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measure of the possible consequences of a hazard
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List 5 factors affecting visual acuity.
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amount and kind of illumination
viewing time object contrast with background object size object color |
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selecting the wrong key
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slip
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forgetting to clear air in an IV line
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lapse
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confusing the meaning of a warning or error signal
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lapse
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failing to detect an alarm condition because of noise
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slip
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assuming a device is working properly when it has actually failed
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mistake (rule)
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performing steps in the wrong order when loading parts into a device
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slip
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applying the wrong therapy on the basis of information given by the device
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mistake (knowledge)
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inverting a glucose meter to steady the finger, but then reading the display result upside down
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mistake (nescience)
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moving a lever or dial in the wrong direction
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slip
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not applying enough force to fully insert a part or connection
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slip
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How to estimate risk?
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P1*P2
(P1 = probability of hazardous situation occurring; P2 = probability of hazardous situation leading to a harm) |
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What is P1?
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probably of a hazardous situation occurring
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What is P2?
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probability of hazardous situation leading to a harm
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Slip is what kind(s) of failure?
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attentional failure
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Lapse is what kind(s) of failure?
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memory failure
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Mistake is what kind(s) of failure?
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rule-based error
knowledge-based error nescient error |
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List five examples of slip.
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(aka attentional failure)
intrusion omission reversal misordering mistiming |
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Give 4 examples of nescient error.
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routine violation
well-meant "optimization" shortcut improvisation in unusual circumstances |
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What does GOMS stand for?
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goal
operator method selection rules |
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Define operator (in context of GOMS).
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actions that the user executes
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List the two types of operators (in context of GOMS).
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external, mental
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What does HSPA stand for?
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human sensory and perceptual abilities
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What is the equation for character height?
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character height = distance(min of arc)/(57.3 * 60)
d0 = distance A = min of arc |
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What are the three elements of color?
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Hue (red, yellow, etc.)
Value (gray scale) Chroma (contrast of colors) |
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What is the best color combo recommendation?
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red and green
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For medical applications in US, what does orange mean?
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alarm (medium priority), warning
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For medical applications in US, what does yellow mean?
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alarm (low priority), caution, slow
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Define the threshold of hearing tones.
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minimum sound level where one can hear
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Define working memory.
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short-term
center of all thought and learning |
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Define long-term memory.
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store meaning of inputs
permanent storage of how-to knowledge |
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What does AHP stand for?
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analytic hierarchy process
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What standard are we using?
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American National Standard: Medical Devices - Application of usability engineering to medical devices (HE75)
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Define workload.
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The input, information processing, and outcome of a task.
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List the steps of information processing/situational awareness.
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perception, comprehension, projection
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What is LEAN?
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a fundamental change in how the people within an organization think and what they value, thus transforming how they behave
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What is kaizen?
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ways to rapidly improve a production system
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What is jidoka?
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safety
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Define value.
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what customers are willing to pay for
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Define value stream.
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the steps that deliver value
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Define flow.
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organizing the Value Stream to be continuous
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Define pull.
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responding to downstream customer demand (internal customers)
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Define perfection.
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relentless continuous improvement (culture)
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What is 5S?
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sort
set in order shine standardize sustain |
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What are the eight wastes?
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defects
overproduction waiting non value-added processing transportation inventory motion (ergonomics) employee |
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What is value stream mapping?
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simple diagram of every step involved in the patient and information flows needed to fulfill a requested service
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Define lead time (LT).
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time it takes one patient (or product) to move all the way through a process or value stream, from start to finish
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Define cycle time (C/T).
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time it takes for one patient (or product) to complete an individual process within the value stream, as timed by observation
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Define value added time (VA).
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portion of the cycle time that a patient is willing to pay for
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What is the calculation for TATK time (for getting smooth patient flow)?
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TAKT time = (work time available/period) / (qty req'd/period)
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What does GTS stand for? And what are the steps of achieving GTS?
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grasp the situation
-plan, do, check, act/adjust |
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What are the five steps of Six Sigma DMAIC?
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1. define
2. measure 3. analyze 4. improve 5. control |
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Define six sigma.
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defines specification limits (tolerance), six sigma away from the mean on bell curve
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Define six sigma in terms of ppm.
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At six sigma, there is a value for ppm. This value states the number of allowable defects (no more than that number).
ppm - parts per million |
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What is the acronym for waste?
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DOWNTIME
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What is the "4P" of the Toyota way?
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forefront is respect for people
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What is A3 thinking?
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PDCA/PDSA
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Which teammate?
generates ideas, models and hypotheses |
Theorist
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Which teammate?
implements ideas, solutions, programs and initiatives developed by the team |
executor
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Which teammate?
extracts the key elements of an idea and develops the process by which the idea can be implemented |
analyzer
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Which teammate?
instinctive ability to detect procedural flaws, logical defects, and other potential problems |
analyze
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Which teammate?
facilitates interaction between other team members and who oversees the implementation of various aspects of the plan |
manager
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Which teammate?
identifies new concepts and ideas in their early stages and develops the strategy behind their implementation |
strategist
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Which teammate?
excels at "thinking outside the box", sees problems from different vantage points |
theorist
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What does TEAM stand for?
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together everyone achieves more
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List the five dysfunctions of teams.
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Absence of trust
Fear of conflict Lack of commitment Avoidance of accountability Inattention to results |
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List the stages of team growth.
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Forming, storming, norming, performing, adjourning
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