ChM STERILE VH202 Instrucciones De Utilizacion página 7

5. The implantation shall be carried out by the surgeon familiar with ad-
equate rules and operating techniques, and who has acquired practical
skills of using ChM instrument set. The selection of surgical technique
adequate for a specific patient remains surgeon' s responsibility.
6. The operation procedure shall be carefully planned. The size of implant
should be determined prior to the beginning of the surgery. An adequate
inventory of implants with required sizes should be available at the time
of surgery, including sizes larger and smaller than those expected to be
used.
7. The surgeon should be familiar with all components of the implant system
before use and should personally verify if all components and instruments
are present before the surgery begins.
8. Do not use the implant if the original, sterile packaging is damaged. Ste-
rility cannot be guaranteed if the package is not intact. The package shall
be carefully checked prior to use.
9. Implants are delivered in protective packagings. The package should be
intact at the time of receipt.
10. Unless supplied sterile, all implants and instruments should be washed,
disinfected and sterilized before use. Additional sterile components should
be available in case of any unexpected need.
11. Before procedure begins, all implants should be carefully checked to en-
sure that there is no damage (surface scratching, dents, signs of corrosion
and shape deformations). Damaged implant must not be inserted into
the body.
8 RECOMMENDATIONS FOR IMPLANTS PROVIDED
STERILE
1. Sterile implant - is delivered in sterile packaging, with the inscription:
"STERILE". Such product is sterile and the manufacturer is responsible
for the process of sterilization. The sterilization is performed with the use
of one of the following methods:
1) gamma radiation, with a minimum dose of 25 kGy,
2) hydrogen peroxide vapour.
2. The symbol designating the sterilization method used is visible on the de-
vice label (symbols are described in the footer of this Instructions For Use).
3. Prior to use of a sterile device the following rules apply:
1) Check out the expiration date of sterilization. Do not use the device with
an overstepped sterility date!
2) Check out if the sterile package is not damaged. Do not use the device
if the sterile package is damaged!
3) Check out the colour of the sterility indicator on the sterile package
which indicates that sterilization of the device was performed. Do not
use the device if the sterility indicator colour is different than:
a) red - for devices sterilized with gamma radiation,
b) blue - for devices sterilized with hydrogen peroxide vapour.
4. CAUTION: products should be removed from their packagings in accordance
with aseptic rules.
9 RE-STERILIZATION
1. It is prohibited to resterilize the solid and modular heads of radial head
prosthesis.
2. It is permitted to re-sterilize cemented stems of the radial head prosthesis
in case of non-compliance with point RECOMMENDATIONS FOR IMPLANTS
PROVIDED STERILE.
1) ATTENTION: An implant which had contact with tissues or body fluids
of a patient must not be re-sterilized and used with another patient.
3. The implant which has not been used but got contaminated by contact
with the blood, tissue and/or body fluids/materials, should not be used
again. The implant should be handled in accordance with applicable hos-
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