Page 2 - Digimed_locking_polyaxial.doc

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 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.