Packaging And Storage - ChM STERILE VH202 Instrucciones De Utilizacion

techniques, and correct placement of implants are important and shall be
considered by the surgeon in order to achieve success during operation.
4. No implant can withstand body loads without the biomechanical continu-
ity of the bone.
5. During normal use all surgical implants are subjected to repeated stresses
which can result in material fatigue and failure of the implant.
6. To avoid excessive stress on the implant which could lead to non-union
or implant failure and associated clinical problems, the surgeon must in-
form the patient about the physical activity limitations during the treat-
ment period.
7. If the patient is involved in an occupation or activity (e.g.: lifting weights,
muscles strain) which may apply excessive stress on the implant, the sur-
geon must inform the patient that resultant forces can cause implant fail-
ure.
8. A successful result is not always achieved in every surgical case. This fact is
especially true in the case where other patient' s conditions may compro-
mise the results.
9. The proper patient selection, compliance of the patient and obser-
vance of post-operative recommendations will greatly affect the results.
The bone union is less likely to occur among smoking patients. These pa-
tients should be informed about this fact and warned of this consequence.
10. Overweight may cause additional stresses and strains within implant
which can lead to fatigue and deformation of the implant.
11. Patients who are overweight, malnourished and/or abuse alcohol or drugs,
with weak muscles and low quality bones and/or with nerve palsy are not
the best candidates for the procedure of surgical stabilization. These pa-
tients are not able or not ready to observe the post-operative recommen-
dations and limitations.
12. The implant may break or become damaged as a result of strenuous activ-
ity or trauma, and may need to be replaced in the future.
13. The surgeon must warn the patient that the device cannot and does not
restore the function and efficiency of a healthy bone.

5 PACKAGING AND STORAGE

1. Implants are single-use devices, provided sterile.
2. Implants not labeled as sterile are non-sterile.
3. Implant packaging must be intact at the time of receipt.
4. The unit package contains:
1) sterile version - one piece of the product in a sterile condition. A double
packaging made of Tyvek-foil or a single blister are typical packaging
material.
5. A sterility indicator is placed on the sterile package.
6. The package is equipped with the product label. The label (as a primary
label) contains e.g.:
1) Sterile product
a) Logo ChM and the address of the manufacturer.
b) Name and size of the device and its catalogue number (REF), e.g.:
3.XXXX.XXX.
c) Production batch number (LOT), e.g. XXXXXXX.
d) Material of the implant (see IMPLANT MATERIAL).
e) STERILE sign - indicating a sterile device and the sterilization method
used, e.g.: R or VH202 (symbols are described in the footer of this Instruc-
tions For Use).
f) Sterilization batch number, e.g.: S-XXXXXXX.
g) Device pictogram and information symbols (described in the footer
of this Instructions For Use).
h) Expiration date and sterilization method.
7. In addition to the device primary label, an auxiliary label with specific
market requirements of a given area may be placed on the unit package
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