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Proposal: Usability Testing of TENS Unit

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November 4, 2019

Introduction
Johnson (2007) describes the TENS unit as a small, battery controlled device with leads linked to sticky pads known as the electrodes. TENS are meant for helping people that are prone to chronic pains; for instance, people suffering from neuropathic pain, Fibromyalgia, arthritis and joint pains, muscle pains as well as back and neck pains. This study aims at evaluating and testing of TENS Unit and its usability. The study will help identify the usability of the device and any modifications required before the summative testing.
This protocol is written as per the following standard
• FDA Final Guidance for Industry and FDA staff: Design Applying Human Factors and usability Engineering to Optimize Medical Device Design (February 3, 2016)
• ANS/AAMI HE75:2015
• FDA Final Guidance for Industry and FDA staff: Design Consideration for Devices intended for Home Use (August 5, 2014)
• IEC 62366-1:2015
2.0 Description of the intended device users, uses, use environments and training
2.1 intended Users
The intended users of the TENS device include;
• Patients who suffer from pain resulting from periods for women, labor pains, postoperative pain, joint, back, and neck pain. It is also used by patients suffering from conditions such as endometriosis, arthritis, and multiple sclerosis.
• Caregivers who have experience in taking care of patients suffering from conditions such as arthritis, endometriosis, and multiple sclerosis.
• Health professionals such as doctors and nurses help to treat pain caused by conditions such as fibromyalgia, arthritis spinal cord injury, and endometriosis.
2.2 intended uses
TENS is used to help reduce pain and muscle spasms caused by conditions such as arthritis, period pains, back, and neck and knee pain, pelvic pain caused by endometriosis. It is sometimes used to relieve pain during labor. It has controls that allow people to administer the required level of pain relief.
2.3 use environment
TENS devise is intended for use at home, or clinical setting or any other situation where there are patients, caregivers, and additional health expertise. The real-life application of the TENS machine may vary in ways that impact the user’s ability to safely and effectively use the tool. The following are some of the environment variables that affect the safe and effective use of the TENS device.
Users should make use of the TENS machine in the right environment setting. Proper maintenance of the device should be observed to ensure the adequate performance of the invention.
2.4 Training
The patients, caregivers and health professionals need to be trained before they are allocated the device. During training, the trainer gives a brief description of the equipment and how it is used. A precise tutorial is also offered to help the patents remember how to use the device while at home. The training targets mainly the untrained personnel to help improve their skills of using the device.
3.0 Description of Device user interface
TENS is a device that is compact and lightweight, battery-operated that is based on solid-state circuitry and user-friendly system.

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