Usability Evaluation of a Portable Oxygen Concentrator

Belluscura

Status: Completed

Conditions: Supplemental Oxygen

Treatments: Device: X-PLO2R POC

Study type: Observational

Funder types: Industry

Identifiers

NCT04299178

BELL_XPLO2R

Details and patient eligibility

About

This study evaluates how well an individual can put together and use a Portable Oxygen Concentrator (POC) by following the instructions in the User Manual.

Full description

The Belluscura X-PLO2R Portable Oxygen Concentrator (POC) is intended for the provision of supplemental oxygen to patients with chronic pulmonary diseases, such as Chronic Obstructive Pulmonary Disease (COPD), and for a patient requiring supplemental oxygen, as prescribed by a physician. The purpose of this study is to evaluate if the X-PLO2R POC can be used by the intended users without serious errors or problems for the intended use and under the expected use conditions. Specifically, the study is to evaluate if potential users of the device can correctly, safely and effectively set-up, activate and operate the X-PLO2R POC to receive the required supplemental oxygen; if the intended user can understand and apply the information contained in the Belluscura X-PLO2R Quick Start Guide and User Manual; and to identify any and all use difficulties, problems and errors made during device assembly and operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older.
• Male or female.
• Suitable for supplemental oxygen use from a suitably qualified and licensed medical professional.
• Voluntarily signed subject consent form.

Exclusion criteria

• Company employee.
• Former human factors study participants.