| Instructions for Titanium bone plates |
The introductions must be read carefully before clinical use |
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1. The plates aid the surgeon in internal implants, they cannot be expected to replace normal healthy bone or withstand the unsupported stress placed upon the plates by full load bearing.
2. To ensure the use of the plates effectively, according to the state of bone damages、the type of bone defects and the surgical target, the model and size of the plates should be checked by X-ray film.
3. The patient is indicated for the merits and faults of the bone plates, and postoperative precautions.
4. The medical staff must be qualified as experienced surgeons for internal fixation in maxillofacial or neurosurgery.
5. Before surgery, prepare the plate carefully to aim the figure anastomose; to avoid the bend、break、speckles and nicks; and also extrude pressure should be avoided to maintain the intensity.
6. The titanium bone plates and titanium bone screws are disposable and can’t be reused.
7. Only our own screws can be matched with the plates and keep the plates separated from other kinds of the screws and other companies’ screws.
8. Titanium bone plates are subject to repeated stresses in use, which can result in fatigue fracture.
9. After the fracture heals 3 months postoperatively, the internal fixation plates and 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 plates is not complete, and as a result, we suggest the plates being taken out on the basis of no intense suffer of the patient for uncertain harmlessness.
10. After being taken out, the plates and the screws must to be deformed for the purpose of not being applied again.
11. The plates and the screws must be sterilized prior to surgical use. |
| >>INSTRUCTION FOR APPLICATION |
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1. Before surgery, please check whether the type of the titanium bone plates is appropriate according to the X-ray film of the patient.
2. The application of the titanium bone plates must be done by qualified doctors.
3. The patient is indicated for surgery.
4. The titanium bone plates are fixed by the titanium bone screws on the cortical bone across the fracture line.
5. After the fixation finished, please treat the cutaneous wound immediately. |
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1. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to the plates.
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 plates 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. |
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Only validated, the sterilization method can be used for the devices. |
>>STORAGE |
The titanium bone plates shall be stored in house with relevant humidity not more than 60%, and with good aeration. |
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