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BHH MIKROMED products are
manufactured and delivered according to the requirements of Directive
93/42/EEC and Quality Management System according to the standards of PN
EN ISO 9001 and PN EN ISO 13485.
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proper selection of the method to the treated case, |
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mastering of the operational technique , |
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adhering to the good medical practice, |
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adhering by a doctor, personnel and a patient to the proceeding rules included in this information and “Important information for implants users.” |
Load-bearing structure of the stabilizer is manufactures of stainless steel, titanium or aluminum alloys.
Implants (nails)
are made of highly alloyed corrosion proof chromic-nickelic-molybdenic
the highest purity steel which meets all requirements included in the
standard of PN EN ISO 5832-1, eventually they are made of titanium or
its alloys according to international standards of ISO 5832-2,3.
In spite of perfect features of the materials use there are
contraindications for implants application defined by the modern medical
practice. Appearing of allergic reactions is also possible.
Instruments
– medical tools are made of corrosion proof steel according to
international standards. Stabilizers elements including tools
manufactured of corrosion proof steel run a risk of corrosion, covering
with stains or damage unless it is treated with the proper care and
listed recommendations.
All stabilizers elements are carefully checked and marked thus
evaluation results are available in the manufacturer’s archive.
Before use all stabilizer elements should be cleaned and thermic sterilized according to the sterilization procedures and instructions.
Implants and
elements of stabilizer are not sterile. Stabilizers should be sterilized
directly before use after unpacking.
Steam pressure sterilization in the autoclave in the temperature of 121°C
and the pressure of 1 atm. for 20 minutes or the temperature of 134°C
and the pressure of 2 atm for 10 minutes is recommended. These
parameters should be regarded as minimal.
Slide surfaces of arbors, wedges, joint staples, threads, should be
lubricated with a thin layer of aseptic lubricant e.g. paraffin.
Assembled stabilizer after checking of its functioning but before it is passed to the operating room should undergo a final radiation or chemical (ethylene oxide) sterilization with a proper quarantine period
Directly after use stabilizers elements including tools should be washed in warm water with a plastic brush. It is recommended to use washing and disinfection means approved for medical applications. After careful cleaning and dying the elements should be covered with a thin layer of lubricant and stored in the temperature of 5-30 oC and relative humidity of maximum 70%. Before the operation a compatibility of all elements should be checked. Next, basing on the x-ray pictures made in two planes arrangement of implants, their amount and distance of the stabilizer from the bone should be planned.
Warnings
Metallic implants will not bear to extensive forces connected with the implantation as well as stresses caused by transmission of the body mass or extensive muscular activity without a full value adhesion. Extensive or repeated stresses may cause loosening of the anastomosis, deceleration or lack of the adhesion as well as implant breaking. This is why it should emphasized that implants will fulfill their purpose only when the following rules are obeyed:
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proper selection of the implant to the patient’s mass and mobility as well as to the planned type of anastomosis is absolutely crucial, |
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forces transferred by the implants should be as low as possible, |
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mechanical damages and scratching of the implant surface should be avoided, |
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implants should be screwed manually or with a slow-speed drill, |
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during the operation a doctor should be sure that implants and other stabilizer elements are precise and fix, |
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no implant may be used repeatedly, because pilling up of the stresses may lead to the easy implant breaking. |
Possible undesirable actions
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sensitiveness to the metal or allergic reaction to a foreign matter in the body, |
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shortening of the limb resulted from the fractured bone compression, |
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decreasing of the bone density, |
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pain, discomfort or improper feeling caused by the implant presence, |
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nerve damage caused by the surgical trauma, |
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bone necrosis. |
Patients informing
Good treatment results depend on the proper post-operational treatment. Patient should have provided a careful post-operational supervision, periodical check-ups and x-ray examinations Each patient should be informed that no anstomosis will bear extensive loads of full body mass or extensive mobility. Patient should be instructed on the hygiene practicing in the area of the anastomosis and should inform a doctor about any changes in the implantation area and any events concerning the treatment even if the implant or operated places do not show any symptoms of damage. Disregard to the above recommendations may lead to the product damage or destruction and cause complications.
PRODUCT NOT STERILE
STERILIZE DIRECTLY BEFORE USE AFTER UNPACKING
Signature IS_stz Rev. 03 /01. 2004/a
