Visco - Facial Head Support
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Visco – Facial Head Support

The Visco – Facial Head Support is a single-use, disposable positioner made of blue and white polyurethane memory foam with a T-shaped cut-out for the eyes, nose, and mouth. Anesthesiologists use it in theatre to support a patient’s face and head and maintain neck and spinal alignment during spinal operations performed in the prone position.

Blue White Holdings, the manufacturer, is SAHPRA-licensed and ISO 13485-certified.

Category:

Description

During spinal surgery, patients lie prone, face-down, for extended periods. The Visco – Facial Head Support cradles the patient’s face and head in that position. Its T-shaped opening leaves the eyes, nose, and mouth clear, so anesthesiologists can monitor the airway and keep the neck and spine aligned throughout the procedure.

Both layers use polyurethane foam, a material not classified as hazardous or as a mixture of dangerous substances. It is lightweight, resists mildew, and will not aggravate common allergies. The Visco – Facial Head Support ships non-sterile, for single use.

Storage

  • Finished products shall be stored in a clean, dry and controlled area, away from direct sunlight, excessive heat, moisture, chemicals, sharp objects and any source that may cause contamination or deformation of the foam.
  • Products shall be stored in a manner that maintains product identification, batch traceability and packaging integrity. Products shall not be stored directly on the floor unless protected by suitable secondary packaging or shelving.
  • Damaged, dirty, compressed, wet or otherwise non-conforming product shall be segregated and handled in accordance with the non-conformance procedure.

Handling

  • Personnel handling the Visco – Facial Head Support shall ensure hands, work surfaces and transport containers are clean and suitable for handling a medical device.
  • The product shall be handled carefully to prevent compression marks, tearing, contamination, loss of labelling, damage to packaging or distortion of the cut-out area.
  • Products shall not be stacked, crushed or exposed to loads that may permanently deform the foam or compromise product performance.
  • Any product dropped, contaminated, damaged or suspected to be non-conforming shall not be released for use and shall be reported to Blue White Medical for assessment and disposition.

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