Page 2 - Digi-Med_Locking_plates_small
P. 2

INSTRUCTIONS  FOR USE 4. (GB)
               Warning: The implants described may only be used in combination with DIGI-MED products!

               OSTEOSYNTHESIS  – TITANIUM  IMPLANTS
               (Bone: Plates / Screws / Pins / Wires / Staples )   non-sterile

               IMPLANT  MATERIAL:
               Implants made from titanium in accordance with ISO 5832-2 unalloyed Titanium; ISO 5832 – 3 Ti6A14V alloy ; ISO 5832 –
               11
               Ti6Al7Ni alloy manufactured by DIGI-MED.The surface of these implants is chemically passive: not magnetic. These
               implants can be combined with the standardised material provided that its composition lies within the analysis stipulated in
               the ISO 5832- 2 / ISO 5832-3 / ISO 5832-11 standard and the required specifications.The material wrought unalloyed
               titanium and alloyed titanium, is biocompatible and prevents a so-called chrome-nickel allergy by its nature


               We would point  out  that  implants only  function

               correctly if the  following basic  rules  are observed:
               When selecting implants (bone: plates / screws / pins wires / clips), care must be taken to choose the appropriate implants
               on the basis of the weight and level of activity of the patient, and the bone fracture to be treated.
               Note that by making the correct choice of biomechanics the forces to be transferred by the implants remain low.

               Extreme deformation of the implants must be avoided; the cautious bending of wires, plates and pins does not, however,

               lead to implant damage provided it is done with sufficient care.
               Repeated deformation should be avoided at all costs as it will fatigue the implant material.
               The re-use of implants is absolutely forbidden (single use).
               We strongly advise you to inform patients of the advantages and disadvantages of implants.
               Excessive strain as a result of body weight and the level of activity of the patient should be avoided due to the limited
               strength of the implants. Failure to observe these precautionary measures can have serious consequences for the healing
               process.

               INDICATIONS
               These relate to the current practice  of applications  of implants in osteosynthesis  (e.g. see literature
               AO/ASIF Instruments  and Implants Texhammer*Colton  ISBN 3-540-56895-6  / ISBN 0-387-56895-6).

               CONTRAINDICATIONS
               Acute and chronic infections;  muscle, nerve or vascular diseases that endanger the affected extremity; a lack of bony tissue
               or poor bone quality (e.g. severe osteoporosis); local bone tumours. Systemic diseases and metabolic disorders; infections
               and falls; drug dependence; obesity; highly physical activities together with activities involving extreme vibrations which can
               lead to overstraining of the implants.

               NOTES
               The user should record and keep all information  provided to the patient.  It should be checked  before use whether
               the patient tolerates  the material to be implanted.  The implants  described  in these instructions  for use may only be
               used (implanted)  by surgeons  with the appropriate  experience.

               POSSIBLE  NEGATIVE  EFFECTS (RISKS)
               Failure  of the fracture to heal, allergy to the material,  failure of the product (break,  bending),  bone deformation
               and refracture,  infection.

               REMOVAL  OF IMPLANTS
               The implants  are normally removed  once the fracture  has healed.

               CLEANING  AND STERILISATION  OF UNSTERILE  IMPLANTS
               Before use, the implants must be sterilised  using a validated  procedure  (autoclaved).

               VALIDATED  PROCEDURES
               STERILISER:  Steam  autoclave: Temperature  = 121° to 123° Celsius; Pressure  = 1 – 1.2 bar (15 to 17 psi) with
               an exposure  time of at least 30 minutes  in the packaged  state.
               STERILISER:   Autoclave  with prevacuum:  During the prevacuum  phase the air is extracted  from the chamber  before
               the steam flows in. Standard  circulation  for packaged  objects: 132° to 135° Celsius; Pressure  = 2 – 3 bar (27 to 30
               psi) with an exposure  time of at least 4 to 10 minutes.

               IMPORTANT  NOTES:
               Every time the implants  are used or sterilised  you must first check that they function  perfectly!
               In the event of failure to observe these instructions  or demonstrable  violation,  no guarantee  or compensation  for
               damages  can be provided.
   1   2   3   4   5   6   7