ChM CHARSPINE system Bedienungsanleitung Seite 8

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) The PLIF PEEK and ALIF PEEK intervertebral cages and their components
(tantalum radiopaque markers) are considered to be safe for patients un-
dergoing an MRI procedure.
4) 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.
5) 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.
6) 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).
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
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