Acetabular Reamer Brush.pdf

Intended Use: The Key Surgical Acetabular Reamer Brush is designed to clean dirty acetabular bone reamers.
Contraindications: No known contraindications or adverse effects.
Preparation: Must be cleaned and disinfected prior to reuse.
Cleaning & Disinfection: Clean after each use and disinfect between cases or daily, at a minimum.
Inspection: Inspect between uses and replace when worn, frayed, bent, or damaged.
Sterilization: Validated for sterilization efficacy using gravity and pre-vacuum steam sterilization.
Storage: Store brushes to reduce cross-contamination.
Disposal: Dispose according to facility protocol.
Warning: Report serious incidents related to the medical device to the manufacturer and competent authority.

Sterilization Parameters:

Gravity: 121°C (250°F) for 30 minutes
* Pre-Vacuum: 132°C (270°F) for 4 minutes or 134°C (273°F) for 3 minutes

Note: New, unused brushes are provided non-sterile and may undergo slight discoloration due to steam sterilization, but this does not affect their functionality.