ChM STERILE VH202 Instrucciones De Utilizacion página 6

(e.g. legal requirements of the country in which the device will be distrib-
uted).
8. The package may contain: Instructions For Use and labels to be placed
in a patient' s medical record.
9. Depending on the size or type of the product, the following information
may be marked on its surface: manufacturer' s logo, production batch no.
(LOT), catalogue no. (REF), type of material and device size.
10. Implants should be stored in appropriate protective packagings, in a clean,
dry place with a room temperature and under conditions that provide pro-
tection from direct sunlight.
6 IMPLANT MATERIAL
1. Identification of the materials
1) Depending on the material used, the following symbols may be marked
on the device surface:
a) Cobalt alloy: symbol (CoCrMo).
2) Solid head of radial head prosthesis is made of UHMWPE (ultra high mo-
lecular weight polyethylene) according to ISO 5834-2.
3) Modular heads of radial head prosthesis are made of biocompatible
polymer PEEK-OPTIMA® Wear Performance (PEEK CFR - polyetheretherk-
etone with carbon fibres), in accordance with ISO 10993 and USP Class VI
regulations, and of cobalt alloy according to ISO 5832-12/ASTM F1537.
4) Cemented stem of radial head prosthesis is made of cobalt alloy, accord-
ing to ISO 5832-12 /ASTM F1537.
5) Percent composition of elements in the implantable materials (max.
values):
a) Cobalt alloy according to ISO 5832-12/ASTM F1537: | Cr:30 | Mo:7 |
Fe:0.75 | Mn:1 | Si:1 | C:0.14 | Ni:1 | N:0.25 | Co:balance.
2. Magnetic resonance compatibility
1) Implants made of titanium, titanium alloys and cobalt alloys are condi-
tionally compatible with magnetic resonance imaging.
2) The patient can be scanned safely under the following conditions:
a) static magnetic field of ≤ 3 Tesla,
b) maximum magnetic field spatial gradient of ≤ 720 Gauss/cm,
c) maximum MR system reported whole-body-averaged specific absorp-
tion rate (SAR) of 3W/kg for 15 minutes of scanning.
3) CAUTION: the user should be absolutely familiar with the contraindica-
tions and warnings established by the manufacturer of the MRI scanner
to be used for imaging procedure.
4) MR imaging may be interfered with if the area of interest is in the exact
same area or relatively close to the position of the implant.
5) Do not perform MRI if there are doubts about the tissue integrity
and the implant fixation or if the proper location of the implant is im-
possible to be established.
7 PRE-OPERATIVE RECOMMENDATIONS
1. Only patients that meet the criteria described in the PURPOSE AND INDICA-
TIONS should be selected.
2. Patients' conditions and/or predispositions such as those addressed
in the above-mentioned CONTRAINDICATIONS should be avoided.
3. Before deciding about implantation, the surgeon shall inform the patient
about indications and contraindications of such procedure and possibility
of complications occurrence after the operation. Patient shall be intro-
duced to the purpose and manner of the procedure, and to functional
and aesthetic effects of such treatment. Proper clinical diagnosis and ac-
curate operation planning and performance are needed to achieve good
final result of treatment.
4. Where material sensitivity is suspected, appropriate tests should be made
prior to material selection or implantation (alloying elements of implant
material are presented in IMPLANT MATERIAL).
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