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Instructions for Titanium bone screws

The introductions must be read carefully before clinical use


>>PRECAUTIONS
 

1.To ensure the use of the screws effectively, according to the state of bone damages、the type of bone defects and the surgical target, the model and size of the screws should be checked by X-ray film.
2.The patient is indicated for the merits and faults of the bone screw, and postoperative precautions.
3.The medical staff must be qualified as experienced surgeons for internal fixation or cranioplasty in the oral surgery,cranio-maxillofacial surgery and neurosurgery.
4.The titanium bone screws are disposable and can’t be reused.
5.Only our own titanium bone plates or titanium mesh or distraction devices can be matched with the screws; keep the titanium bone screws separate from other kinds of implants and other company’s implants.
6.After the fracture heals 3 months postoperatively, the internal fixation screws become functionless and are seen as foreign bodies. Although no evidence of harm by the plates has been proved till now, our knowledge of the titanium bone screws is not complete, and as a result, we suggest the screws being taken out on the basis of no intense suffer of the patient for uncertain harmlessness.
7.The screws used for cranial defect should be checked periodically based on clinician suggestions.
8.After being taken out , the screws must to be deformed for the purpose of not being applied again.
9.The screws must be sterilized prior to surgical use.


>>INSTRUCTION FOR APPLICATION
 

1.Before surgery, please check whether the type and size of the titanium bone screws is appropriate according to the X-ray film or the CT film of the patient.
2.The application of the titanium bone screws must be done by qualified doctors.
3.The patient is indicated for surgery.
4.The titanium bone screws used for internal fixation or reconstruction are used to fix the titanium bone plates on the cortical bone across the fracture line.
5.The titanium bone screws used for repair skull defect are used to fix the titanium mesh plates on the border of the skull.
6.After the fixation finished, please treat the cutaneous wound immediately.


>> CONTRAINDICATIONS
 

1. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
2. Patients with limited blood supply, insufficient quantity or quality of bone, or latent infection.
3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
4. Forbidden to be used to patients with tumor, infection, inclination of hemorrhage, hypersensitivity to metal and patients who have contraindications to surgery.


>>STERILIZATION

Recommend method as follows:
Titanium bone screws should be sterilized under high pressure and high temperature for half an hour.
Since Ningbo Cibei Medical Treatment Appliance Co.,Ltd. is not familiar with each hospital sterilization methods, cleaning methods and bioburden, we cannot assume responsibility even though the recommend method is followed.

  Only validated, the sterilization method can be used for the devices.

>>STORAGE

The product shall be stored in house with relevant humidity not more than 60%, and with good aeration.

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