Page 54 - Safety Risk Management for Medical Devices

Usability Engineering and Risk Analysis 33

(Continued)
Term Definition
Misuse Incorrect or improper use of the medical device [3] 4.2
Note: This is not an official definition
Normal Use Operation, including routine inspection... according to the
instructions for use or in accordance with generally accepted practice
for those medical devices without instructions for use [14] 3.9
Perception Error One of the causes of Use Error. Related to deficiency in perception,
and not primarily due to cognition deficiencies or the inability to
perform the action
Primary Operating Function that involves user interaction that is related to the safety of
Function the medical device [14] 3.11
Slip The Use has the knowledge and the intention, but executes
incorrectly. Attentional error
This term was used in IEC 62366 2007 version, but not used in the
2015 version
Summative User interface evaluation conducted at the end of the user interface
Evaluation development with the intent to obtain objective evidence that the
user interface can be used safely [14] 3.13
Note: Summative evaluations are frequently used to provide
verification of effectiveness, of risk controls
Task One or more user interactions with a medical device to achieve a
desired result [14] 3.14
Note: A task can be further broken down into “steps”
Usability Characteristic of the user interface that facilitates use and thereby
establishes effectiveness, efficiency, and user satisfaction in the
intended use environment [14] 3.16
Use Error User action or lack of user action while using the medical device
that leads to a different result than that intended by the
manufacturer or expected by the user [14] 3.21
Note: Use Error includes the inability of the user to complete a task
Use Failure Failure of a User to achieve the intended and expected outcome
from the interaction with the medical device
Note: Inability to perform a task, as well as Use Errors are Use
Failures
Use Scenario Specific sequence of tasks performed by a specific user in a specific
use environment and any resulting response of the medical device
[14] 3.22
User Interface (UI) Means by which the user and medical device interact [14] 3.26
Note: User interface includes all the elements of the medical device
with which the user interacts including the physical aspects of the
medical device as well as visual, auditory, tactile displays and is not
limited to a software interface