All American Career College Medical Device Usability Paper Hello, My professor want us to do the following: Please write a one-page reflection of class t

All American Career College Medical Device Usability Paper Hello,

My professor want us to do the following:

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Please write a one-page reflection of class this semester. What did you learn? What methods did you enjoy? Not enjoy? Any techniques you can see yourself applying in your career? Anything else you wish you learned? Following the same formatting directions as all other reading responses. Please also submit any outstanding reading responses by 11/25 as well. They WILL NOT be accepted after next Monday.

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i will attach syllabus to help you understand what is this course and also i will attach my final G project please let me know if you have any Questions MEDICAL DEVICE ERRORS WITH TENS UNITS
Medical Device Errors with TENS Units
Nadiah Alyamni
Faris Albakhat
Abdulelah Bakdam
Medical Device Errors with TENS Units
Pain is an unenviable experience in human lives. It ranges from acute to chronic pain, and some
people get it daily. Acute pain is mild and only lasts for a shorter duration, while chronic one is
experienced over a long period and can prolong over six months. While the former does not have a huge
impact, the latter decreases a person’s quality of life. Pain has several negative impacts on the body,
which includes reduced quality of life, impaired physical health, and potential death. According to the
National Institute of Health, nearly 80 percent of adults will experience back pain at least once in their
lifetime (2019).However, to address the problem, experts have developed several systems, such as
Accumed Rechargeable Tens Unit Muscle Stimulator (EMS), to relieve the pain and improve quality of
Accumed Rechargeable Tens Unit Muscle Stimulator
The devise is an eight modes AP210 type Tens Unit manufactured and supplied by AccuMed. The
machine has eight components designed for different therapeutic methods and muscle stimulations. The
message function performs soft messages mainly soft squeeze and release. The ear component provides
small but sensitive pulse modes. Acupuncture mode gives strong pulses that fade gradually. Other
components include cupping and scrapping functions. They both provide a sudden pressure, but the latter
has a gradual fade. The beat mode gives a strong but hastily pulse, while sole produces a short, gradually
increasing pulse. Lastly, the combo function combines acupuncture, beat, scraping and message routines.
Therefore, people tune the device to various modes depending on the type of pain they experience.
Working and Treatment of Pain Using the EMS Device
The EMS device uses its eight auto-routine features designed based on muscle stimulation and other
therapeutic needs. Additionally, the device is helpful in treatment of pain caused by inflammation, nerve
damage, infections, and strenuous body workouts. The device works in two ways, which includes sending
low voltage to block signals through the skin and enhance effective blood circulation. Additionally, the
device is used to sooth the skin and enhances muscle relaxation. Furthermore, the device has a voltage
control knob that ensures the user can vary the treatment form gentle squeeze to rhythmic and restorative
acupuncture. Therefore, the EMS device is suitable for treatment of acute and chronic pains.
The device is quite simple to operate and most people can conveniently use it without any
specialized skills. To start the device, the electrode lines are plugged into the unit at one terminal, while
adhesive pads are connected to the other terminal. The pads are placed on body sections experiencing
pain, such as knees, legs, shoulders or backs. The unit is powered and the necessary routine or mode, such
as beat or combo, is selected. The process of the treatment is indicated on the gadget’s LCD display.
Besides the simple operation procedure, EMS is portable and rechargeable. Unlike most medical
machines, the device is light; hence, it is highly mobile. Therefore, people can move it to the most
convenient location and connect it to a power source. Additionally, the charging capacity of the gadget
enhances its portability. Once charged, the machine can operated in almost all places without any
The EMS device relive pain in patients within many health centers, which operates mainly by
sending a carefully generated low voltage electrical pulses to the brain to produce natural endorphin,
which stops all signals to the brain. The process stops the pain and allows the body to regenerate
naturally. Additionally, blocking the nerve signals prevents the body from reacting, which enables proper
blood circulation to the tired or sore muscles, which enhances relaxation. A variety of users from different
ages and genders can use the device. However, it is mainly suitable in relieving pain in specific body parts
and organs, including upper and lower back, thigh, knees, and foot. Additionally, the device has been
prevalent in sports to relieve muscle and joint injuries and over-exercise discomfort (Amazon). A person
should receive at least a minimum of 20-minute massage to experience a positive impact on the device.
Effectiveness and Medical Errors in the EMS device
The EMS device has dramatically gained popularity having attained a 4.5-star rating out of a
scale of five with more than 180 reviews. Most individuals who have purchased and used the device are
positive about the results and indicate it relieves pain. Additionally, the device is easy to use, which only
requires connection to a power supply and placement of the massage pads on the treatment area.
Furthermore, the EMS is natural, unlike drugs, and it is portable with a rechargeable 42V@500Ohms
battery (Amazon). However, several users gave negative reviews citing that the device discharged
quickly and caused muscle and tissue damages when used for a prolonged duration. Moreover, the device
can cause electric shocks and burns, which may be severe to cause death. Furthermore, in rare instances,
the device can cause ear damages, when the voltage exceeds 20V. People should avoid using the device
for a prolonged duration of over 60 minutes (1 hour) to prevent skin damage.
Heuristic Evaluation
Study Design
The inspection procedure will use the Heuristic evaluation method to evaluate the errors on the
Accumed Rechargeable Tens Unit Muscle Stimulator. Heuristic evaluation involves a systematic
assessment of a user interface to identify the problem experienced by the consumers of the device. It will
use ten heuristics that form the basis of the inspection the problem on the equipment. The ten usability
heuristics include the visibility of the system status, the match between the system and real-world, user
control and freedom, consistency, and standards, and error prevention (Nielsen, 2015). Additional
heuristics involve recognition rather than recall, flexibility, and efficiency of use, and aesthetic and
minimalist design (Nielsen, 2015). The final standards involve assisting the user to recognize, diagnose,
and recover from errors, and helping and documenting.
Sample Population
The team of evaluators will comprise five usability specialists who have the knowledge and
experience with usability principles. Each of the participants will inspect and evaluate two heuristics out
of the list of the ten. The use of five evaluators will enhance the reliability of the outcomes and minimize
the level of bias. It will also enable each usability specialist to identify specific problems compared to
relying on one person to inspect all the aspects.
The Procedure of Evaluation
The evaluators will be briefed on the scope of the inspection and the characteristics of the enduser of the device. Each of the participants will be assigned two heuristics to inspect. They will be
provided with examples to ensure they understand what they are inspecting to minimize errors and
enhance the credibility of the results. The assessors will be allowed to work independently to complete
the assigned heuristic. They will be required to record the problems identified on the form to specify the
heuristic violated by the malfunctioning of the device. For example, if the problem identified involve
failure to display a valid format for the data, the violated the heuristic is the error prevention and
Aggregation of the Findings
After the inspection, the evaluators will analyze the results and provide a possible solution to the
uncovered problem. Finally, they will gather to analyze the complications identified and the possible
remedy provided. The collaboration will enable them to combine the errors evident on the device and
eliminate the duplicate problems. The presentation of the faults and the possible solution will focus on the
ten heuristics to avoid creating a long list of problems.
Usability Testing
Study Design
Usability testing is another method that will be used to inspect the device to identify the problem.
It involves inspecting the design of the system to evaluate its safety, efficiency, and effectiveness to the
end-user. The usability test helps in the identification of possible problems that the consumers encounter
when using a product or equipment. It examines the effectiveness and efficiency of the device or the
product in the real world. The findings enable the developer to improve the design based on the results.
Sample population and sampling procedures
The sample population will comprise of 10 patients who experience muscle pain. The participants
will include five females and five males aged between 25 and 35. The study will use the people who have
prior experience with the device to enhance the reliability of the findings and minimize bias. The
researcher will announce the testing exercise on the website to access the respondents willing to
participate in the process of testing.
Testing Procedures
The researcher will explain the conditions of the test to the participants and provide them with the
consent form to sign before starting the process. The respondents will be guided to use the machine and
asked to record the problems they experience when using the device. They will be placed in separate
rooms to allow them to identify the problem independently.
Each patient will be provided with usability heuristics, including visibility, convention, and
metaphor, autonomy, consistency, standards, error prevention, recognition, and diagnostics. Additional
aspects involve flexibility, efficiency, aesthetics, accessibility, and help (Chagpar, n.d). The use of
usability testing heuristics enhances the credibility of the findings obtained from the heuristic evaluation
that lacks the inputs of the real users. The participants will be guided to match the problem identified with
the heuristic violated by the malfunctioning of the device.
Aggregation of the Findings
After the test, the participants will fill the form stating the problems identified and
recommendations for improvement. The researcher will consolidate and analyze the findings to identify
the frequently mentioned issue and the actions recommended to improve the efficiency and functionality
of the device. After the evaluation and analysis of the results, the scholar will prepare a report containing
the frequent problems, the feedback of the users, and the recommendable actions of improvement. The
finding of the usability testing will provide further insight into the problems from the end users’
perspective to enable the developer to improve the design of the equipment.
Amazon. AccuMed Rechargeable Tens Unit Muscle Stimulator EMS Electronic Pulse Massager Stim
Machine for Physical Therapy Back and Neck Pain Relief Portable Electric Tinge ElectroTherapy 16 Modes (AP212). Retrieved from,
Chagpar, A. (n.d). Human Factors Requirements for Premarket Medical Device Approval. Healthcare
Human Factor. Retrieved from
Moore, A., Wiffen, P., & Kalso, E. (2014). Antiepileptic drugs for neuropathic pain and
fibromyalgia. Jama, 312(2).
Nielsen, J. (2015). How to conduct a heuristic evaluation? 1995. Recuperado de. Retrieved from
Świeboda, P et al., (2014). Assessment of pain: types, mechanism and treatment. Pain, 2(7).
Medical Device Usability
(Fall 2019)
Course Description:
This in-person course presents fundamental concepts of medical device usability, leveraging insights from multiple
disciplines that are essential to understanding user requirements, formulating usability goals, device evaluation, and
recommendations for redesign. A portion of medical errors are those that arise from the use of technology in medical
care. An increasing amount of technology and technological equipment is used in medical care and the technology
becomes increasingly complex each year. Evaluating and predicting patient safety in medical device use is critical for
developing interventions to reduce adverse events and medical errors either by redesigning the devices, or if redesign
is not an option, by training the users on the identified trouble spots in the devices. The curriculum represents an
interdisciplinary program that prepares students for practice in their emerging profession through a course sequence
that emphasizes theory, practical applications, and research. The course includes core topics from biomedical
engineering, industrial engineering, cognitive psychology and others. Pulling these pieces together ensures a
comprehensive approach to medical device design and evaluation to optimize usability, reduce costs, and ensure
efficiency. Students will engage is a semester long project to evaluate a medical device of their choice to include
recommendations and potential redesign based on the concepts introduced in this course.
Course Objectives:
• Define usability and the design principles that determine the quality of design and usability
• Gain exposure to methods and techniques devoted to the study of medical device usability
• Apply user-centered design in the medical device domain
• Evaluate everyday products and environments from a user’s point of view
(1) Aug 26
Course Introduction
Sept 2
No Class
(2) Sept 9
Medical devices defined and usability 101
(3) Sept 16
User-centered design and design principles
(4) Sept 23
Heuristic evaluation
(5) Sept 30
Product usability and people-centered design
(6) Oct 7
Designing and conducting simulated use evaluation
Week of Oct 14
No Class: Project Proposals Due
(7) Oct 21
Formative, summative, and comparative usability testing
(8) Oct 28
Cognitive walkthroughs
(9) Nov 4
Usability, safety, and health information technology
(10) Nov 11
Digital health
(11) Nov 18
Post-market surveillance and practice presentations
Nov 25
No Class
(12) Dec 2
Final Student Presentations
Week of Dec 14
Final Report Due
Learning Format and Course Expectations:
As part of the course students will be required to complete weekly assignments. Students will also participate
in a group project that will provide the opportunity to translate learned skills into clinical application. There
are no items required to purchase for this course. All materials will be provided electronically via BlackBoard
and/or email.
Grades are assigned based on the following criteria:
Letter Grade
Percent Grade
4.0 Scale
Below 65
Grades will be based on scores from the weekly assignments and participation in discussions:
Weekly Assignments: 30%
Group project: 50%
Participation: 20%
Weekly Assignments:
Students are assigned one weekly reading assignment (ten total) to include peer-reviewed seminal or
breakthrough articles specific to the upcoming lecture. Students are required to summarize the findings of the
article in a single page summary (one page +/- one paragraph, single-line spacing, 11pt font) and include a
comment and/or question for discussion. The comment may include how materials relate to other course
concepts or examples from your own life experience. The question may address any aspect of the paper including
something that was confusing or about applying the material to different contexts. The completed assignments
will be submitted before the lecture when the reading will be discussed (Sunday evening by 10pm). Full credit
will be given for submitting on time with reasonable content (1 point), including both summary questions and/or
comment (1 point), and meeting length requirements (1 point). A brief grace period of 30 minutes or less will
apply in order to account for occasional technical difficulties in submitting work. Timely submission of work is
important to keep pace with the course and to allow time to review grading feedback to guide maximum
performance on subsequent work.
Group Project:
The semester project is a creative exercise where students are expected to take what they learn each lecture
(both in and out of the classroom) and create a polished evaluation of a medical device, applying real world
solutions to design and deployment. Students must work in groups of three or more. All groups are required to
submit a preliminary proposal that describes their project idea, tentative approach, and possible methods of
evaluation. All proposals will be reviewed for suitability, which is dependent on the group size, complexity of
proposal, experience level of group members, etc. Student groups are not bound to their proposal and may make
modifications to their original ideas and/or approach throughout the course. Project presentations will take place
during the last week of class. A final report (no more than 10 pages) summarizing background, methodology,
findings, and recommendations will be due finals week.
Attendance/ Participation:
Attendance for this course is mandatory. All unexcused absences will negatively affect your final grade. We
realize that many of you have full-time jobs, families, and other commitments, so we are absolutely happy to
grant absences in most circumstances. Please just shoot both faculty an email if you intend to miss class,
preferably earlier than an hour before class begins. Participation refers to any discussion/ interaction/exchange,
written or oral, during the course of classroom lecture, discussion, or small group work. It also refers to
interactions/exchanges carried out outside of the classroom in the general context of class assignments (e.g.,
meetings during office hours with the instructor or meetings with one’s group outside of the classroom for work
on group projects). The nature and extent of a student’s participation could bump up his/her final grade half a
letter (for example, from a B to a B+ or a B+ to an A-. We also reserve the right to lower grades based on lack of
participation should the need arise.
Study Test Plan
Description of Intended Device Users, Uses, Use Environment, And Training
The Intended Device Users
The intended users are classified into three different categories. The first group comprises of
patients experiencing both acute and chronic muscle pain on different body parts and organs,
including knees, thighs, foot, and back. The second class includes the caregivers who care for the
patient suffering from muscle pain. The final group involves licensed medical specialists, such as
nurses, physicians, and therapist. They ought to have the experience of caring for patient with acute
and chronic muscle pain.
The Intended Use
Accumed Rechargeable Tens Unit Muscle Stimulator (EMS) is used to treat pain resulting
from infections, nerve damage, inflammation, and strenuous body workout. It also sooths the skin
and enhances muscle relaxation. The device generates low voltage electrical pulse and transmits
them to the brain to produce natural endorphin, block signals, and improve the circulation of blo…
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