ChM CHARSPINE system Bedienungsanleitung Seite 11

7. Sterilization
1) Washed, disinfected, and dried device shall undergo the sterilization
process in accordance with the applicable procedures of the customer.
The recommended method of sterilization is vacuum-type steam steril-
ization (with water vapor under overpressure):
a) temperature: 134°C,
b) minimum exposure time: 7 min,
c) minimum drying time: 20 min.
2) CAUTION
a) The sterilization process must be validated and routinely monitored
in accordance with the requirements of EN ISO 17665-1.
b) Sterilization must be effective and in accordance with requirements
of the EN 556-1 standard to ensure the required level of guaranteed
sterility SAL 10
c) Implant must not be sterilized in the packaging in which it was deliv-
ered.
d) The method of sterilization using ethylene oxide, gas plasma and dry
heat should not be used, unless the Instructions for Use for the product
contains sterilization recommendations using these methods.
e) The above-mentioned principles for cleaning and sterilization must be
applied to all implants intended for implantation.
f) The surgical instruments used for implants insertion should also be
covered by cleaning and sterilization procedure.
10 RE-STERILIZATION
1. It is permitted to re-sterilize a device in case, when its sterile packaging
has been damaged or opened. In this case, the product should be washed
and sterilized in the manner described in the chapter RECOMMENDATIONS
FOR IMPLANTS PROVIDED NON-STERILE.
1) ATTENTION: Implant that has been in contact with body tissues or fluids
of a patient cannot be re-sterilized or implanted to another patient.
11 PRECAUTIONS
1. Implant is intended for single use only. After removing the implant from
the patient' s body, it must be secured against re-use, and then finally dis-
posed of in accordance with current hospital procedures.
2. Under no circumstances is it allowed to re-use or re-implant once used de-
vice. Even if the removed implant appears to be undamaged, it may have
small latent defects or internal stresses, which could lead to early failure,
fatigue wear, and as a result to e.g. an implant breakage.
3. Misuse of instruments or implants may cause injury to the patient or op-
erative personnel.
4. Avoid damaging implant surface and deforming its shape during the im-
plantation; the damaged implant cannot be implanted or left in the pa-
tient' s body.
5. Insertion, removal and adjustment of implants must only be done with
instruments specially designated for those implants and manufactured
by ChM sp. z o.o.
6. Use of ChM' s implants and instruments in combination with implants
and instruments from other manufacturers may cause damage or failure
of those implants or instruments and may lead to improper course of sur-
gery and healing process.
7. While rare, intraoperative fracture or breakage of the instrument can occur.
Instruments which have been subjected to prolonged use or excessive force
are more susceptible to fractures, depending on care taken during surgery,
number of procedures performed and attention paid. Instruments should
be examined for wear or damage prior to surgery.
8. Extreme caution should be exercised around the spinal cord and nerve
roots. Damage to the nerves will cause a loss of neurological functions.
9. To assure proper fusion below and around the implant site, an autogenous
bone graft must be used.
(where SAL stands for Sterility Assurance Level).
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