acumed Dual-Trak Mode D'emploi page 3

US Instructions for use
Caution:
•
The implants and instruments are intended only for professional use by a licensed physician.
•
Do not use or re-sterilize an implant provided in sterile packaging if the package has been damaged.
The sterility may be compromised and the cleanliness of the implant may be uncertain. Report
damaged packaging to your distributor or Acumed.
•
Mixing implant components from different manufacturers is not recommended for metallurgical,
mechanical and functional reasons.
•
Do not use the sterile product past the use-by date. Refer to the device label.
•
Do not reuse single use surgical instruments. The instrument may suddenly fail as a result of
previous stresses.
•
Do not resharpen drill bits or reamers as these devices have critical dimensions and geometries that
cannot be restored once the instrument has been consumed.
•
Do not use chemical disinfection methods as chemical residues may affect steam sterilization.
•
Do not block holes in the case or trays, for example with labels, as this may adversely affect steam
penetration and sterilization.
•
Screws, tacks, Kirschner wires, guidewires, cutting instruments, and similar devices may be sharp.
Observe hospital procedures, practice guidelines, and/or government regulations for the proper
handling and disposal of sharps.
ADVERSE EFFECTS
Possible adverse effects include:
• Pain, discomfort, or abnormal sensations, nerve or soft tissue damage, necrosis of bone or tissue, bone
resorption, or inadequate healing from the presence of an implant or due to surgical trauma.
• Implant fracture due to excessive activity, prolonged loading upon the device, incomplete healing, or
excessive force exerted on the implant during insertion. Implant migration and/or loosening may occur.
• Metal sensitivity, histological, allergic or adverse foreign body reaction resulting from implantation of a
foreign material. Consult our document "Metal Sensitivity Statement" at www.acumed.net/ifu.
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.
Important: The instruments and implants in this system are intended to be used by suitably trained
and qualified surgeons in a hospital operating room setting. Before treatment, the surgeon is
advised to read and fully understand all instructions and communicate to the patient any relevant
medical information provided therein, including the use, limitations, risks (safety communications),
and possible adverse effects of the proposed treatment.
Consult the most recent versions of the Instructions for Use and Surgical Techniques as they are
subject to change. Contact Acumed or an authorized agent to request any additional information.
U.S. English – US / PAGE 3