acumed RibLoc U Plus Gebrauchsanweisung Seite 4

US Instructions for use
• A histological or allergic reaction resulting from the implantation of a foreign material in the body may
occur.
The implant contains metal that may induce an allergic reaction in patients with an allergy or sensitivity
•
to metallic components.
SURGICAL TECHNIQUE
Acumed offers one or more Surgical Techniques to promote the safe and effective use of this system. Consult
our Surgical Techniques at www.acumed.net.
Important: Surgical techniques may contain important safety information.
MRI SAFETY INFORMATION
Many Acumed implants have been evaluated for safety in the MR environment and have deemed to be MR
Conditional. Consult our publication "Acumed Implants in the MR Environment" at
more information.
PROCESSING
Important: Processing personnel must be qualified with suitable training and experience. Use proper personal
protective equipment (PPE) when working with contaminated devices.
PRECAUTIONS
The RibLoc® U Plus Chest Wall Plating System products are provided non-sterile and require cleaning
•
and sterilization prior to use.
• Any device contaminated with blood, tissue or other bodily fluids should be handled according to
hospital protocol. Personal protective equipment should be utilized when working with contaminated
or potentially contaminated devices.
• In accordance with AORN and AAMI guidelines, Acumed does not recommend or support immediate
use steam sterilization (also known as flash sterilization) of implants is not recommended.
Lumens, channels, crevices, joints, mating surfaces and threads require particular attention during
•
cleaning. Flood with copious amounts of cleaning solutions using a syringe to flush out soil.
Caution should be exercised when handling instruments with sharp points or cutting edges.
•
Do not use metal brushes or scouring pads during manual cleaning process.
•
The use of neutral pH enzymatic and cleaning agents is recommended. If alkaline cleaning agents are used,
neutralize and thoroughly rinse from device.
LIMITATIONS ON REPROCESSING
Instruments are designed to withstand typical cleaning and steam sterilization cycles.
•
Instrument end of life is normally determined by damage and wear due to use. Instruments and
•
implants should be inspected after cleaning for damage such as corrosion, scratches and wear.
• Damaged instruments should be returned to Acumed for replacement.
U.S. English – US / PAGE 4
www.acumed.net/ifu for