ChM STERILE VH202 Instrucciones De Utilizacion página 10

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.
11 POST-OPERATIVE RECOMMENDATIONS
1. It is essential to follow all of physician' s postoperative directions and warn-
ings.
2. It is essential to confirm proper position of the implant by roentgeno-
graphic examination.
3. Also in the post-operative period, during healing, correct implant position
should be confirmed by roentgenographic examination.
4. The patient should be warned about the risk should he fail to follow
the above-mentioned rules, or should he be unavailable for follow-up
clinical examination.
5. The surgeon must instruct the patient to report any unusual changes
of the operative site to his/her physician. If any change at the site has
been detected, the patient should be closely monitored.
6. The patient should be informed about the type of implant material.
7. The patient should be warned to inform the medical staff about the in-
serted implants prior to any MRI procedure.
8. The patient should be advised not to smoke or consume alcohol excessively
during the period of treatment.
9. If the patient is involved in an occupation or activity which may apply ex-
cessive stress on the implant (e.g. weights lifting, or muscle strain) the sur-
geon must advise the patient that resultant forces can cause implant fail-
ure.
10. The surgeon must instruct the patient regarding appropriate and restrict-
ed activities during treatment period in order to prevent placing exces-
sive stress on the implants which may lead to implant failure and further
clinical problems. The implant may break or become damaged as a result
of strenuous activity or trauma, and may need to be replaced in the future.
11. Fatigue stresses may be a potential cause of implant becoming bent, loos-
ened or fractured. If bending, loosening or fracture occurs, the patient
should be immediately revised, and the implants should be removed be-
fore any serious injuries occur. The patient must be appropriately warned
about these risks and closely monitored to ensure compliance during
the treatment.
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