| Instructions for Customers/Users |
Customers are to follow the Instructions for Use (IFU), in particular:
· As with any fixation device, excessive pressure introduced by the device and/or the patient’s head and/or body position (e.g. prone or side-lying) may cause dermal injury, tissue ischemia, or necrosis.
· To minimise the risk of pressure injury, inspect the patient’s lips, skin and oral cavity at least every two hours or more frequently if the patient’s condition dictates (e.g. vulnerable to fluid shifts and/or oedema).
· Use caution in patients with full or swollen lips, facial swelling, dental appliances, restorative implants, and/or loose or protruding teeth.
· Discontinue use of the device if redness, skin irritation, or pressure injury occurs.
This action has been closed out on 20/08/2026 |