|
Implants
are made of highly alloyed corrosion proof chromic-nickelic-molybdenic
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.
Implants were manufactured according to the international
recommendations, directive 93/42/EEC, and the Quality Management System
and in the matter of designing and manufacturing of medical devices
according to the standards of PN EN ISO 9001 and PN EN ISO 13485.
Application of the System is confirmed by the certificate no.
78/100/2805 and 78/706/2805 issued by the TÜV CERT Hannover, Germany.
The products may be modified thus it is recommended to control their
compatibility before the operation.
Cleaning, sterilization,
storage
Implants are
not sterile. Implants should be sterilized directly before use after
unpacking. Implants unpacked directly before sterilization do not have
to be cleaned. In other cases implants should be carefully cleaned with
the means approved to the medical use. While cleaning attention should
be paid not to change implants shapes, damage or scratch the implants
surface which cause destruction of the passivated layer. Steam pressure
sterilization in the autoclave according to the binding procedures is
recommended, in temperature 121°C
and the pressure of 1 atm for 20 minutes or in temperature 134°C
and the pressure 2 atm for 10 minutes. These parameters should be
regarded as minimal Products should be stored in the way protecting
packaging and the implant itself from damages. Products should be
protected against moisture /temperature of storage 15-30°C,
relative humidity max. 70%/
Implants
use
Implants
purpose is temporary stabilization of bone fractures. After treatment
finishing implant should be removed unless the risk of reoperation is
high and no indication to implant’s removal appear. Detailed indications
for implants application are included by the actual medical practice.
Good treatment
results are conditioned by:
 |
proper
selection of the method as well as kind and size of the implant
depending on the treated case, |
|
mastering
of the operational technique , |
|
adhering
to the good medical practice, |
|
adhering
by a doctor, personnel and a patient to the proceeding rules
included in this information. |
Contraindications
|
insufficient quantity or quality of the bone (defects, bone
weakening), |
|
latent or
active infections of bones, internal or surface infections,
|
|
bones
blood supply handicap or previous infections, |
|
states
which may cause restriction in patient’s ability to adhere
prescriptions (mental or neurological diseases etc.), |
|
allergies
to the implant, allergies which must be excluded before the
implantation. |
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:
|
proper
selection of the implant to the patient’s mass and mobility as well
as to the planned type of anastomosis is absolutely crucial,
|
|
forces
transferred by the implants should be as low as possible,
|
|
mechanical
damages, scratching of the implant surface or shape changes should
be avoided, |
|
implant
bending should be avoided. If the deformation is necessary it should
be minimal, single and made outside of the implant aperture area, |
|
loads
applied while implanting should be as low as possible ad adjusted to
the implant’s and the bone strength, |
|
a doctor
should be sure that implants and bone fractures connections are
precise and fix, |
|
implants
applied should have the same chemical composition and features, |
|
no implant
may be used repeatedly because pilling up of the stresses may lead
to the easy implant breaking, |
|
attention
should be paid to hazards connected with application of modern
diagnostic and therapeutic methods in which electric and/or magnetic
fields appear, |
|
patient
should have provided a standard post-operational supervision till
the end of the treatment, |
|
each
patient should be informed that no implant will bear tensions caused
by the whole body mass or extensive mobility. |
Possible undesirable actions
|
sensitiveness to the metal or allergic reaction to a foreign matter
in the body, |
|
shortening
of the limb resulted from the fractured bone compression,
|
|
decreasing
of the bone density, |
|
pain,
discomfort or improper feeling caused by the implant presence,
|
|
nerve
damage caused by the surgical trauma, |
|
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
DO NOT USE REPEATEDLY
Signature IS_imp Rev.
03 /01. 2004/a |
