The Laryngeal Endo-tracheal Airway Fixator(LEAFix) is a single use product designed to secure airway devices to patients during anaesthesia, with better infection control management and interaction with the patients skin. This study investigates the users of the LEAFix device interacting with the LEAFix device, its packaging and a simulated patient through different scenarios of securing an airway device. The aim is to understand the risks associated with the use of the device for CE marking purposes. This study is funded by Innovel Ltd. the manufacturer of the device.
Study Type
OBSERVATIONAL
Enrollment
32
Users observation using medical device on manakin, different scenarios per group
Performance of user against the predetermined standard
The users will be marked against a standard set to look for problems
Time frame: 1 hour
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