| Instructions for Intermaxillary distraction devices |
The introductions must be read carefully before clinical use |
| >> POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS |
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1. Mechanical failure and operation failure.
2. Bone cortex-cutting inadequacy.
3. Pain or numbness of distraction region.
4. Inflammation of cutaneous wound around the distraction region .
5. Malocclusion.
6. Bone unhealing, pseudoarthrosis.
7. The fixation of the devices falls short of operation designed plan.
8. Breath blocked after operation. |
| Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the distraction devices. |
| >>PRECAUTIONS |
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1. Before surgery, please check whether the type and size of the distraction is appropriate according to the X-ray or CT film of the patient.
2. Adequately preoperative preparation and postoperative care are very important.
3. The medical staff must be qualified in local country as experienced surgeons for orthopedics, maxillofacial or head and neck surgery.
4. Only our own screws can be matched with the distraction devices; keep the distraction devices separate from other kinds of screws.
5. The operator must be familiar with the instruction of distraction and direction of the distraction devices.
6. The distraction devices are disposable and can’t be reused.
7. The distraction devices are subject to repeated stresses in use, which can result in fatigue fracture.
8. Deform the products after being taken out for the purpose of not being applied again.
9. Proper rest is necessary after operation, avoiding unnecessary movement or activities.
10. The devices must be sterilized prior to surgical use. |
Recommend method as follows:
Distraction devices 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 devices. |
Forbidden to be used to patients with tumor, infection, inclination of hemorrhage, hypersensitivity to metal and patients who have contraindications to surgery. |
| >>STORAGE |
The product shall be stored in house with relevant humidity not more than 60%, and with good aeration.
Surgeons and all personnel involved with handling these products are responsible for attaining appropriate education and training within the scope of the activities, which they are involved in the handling and use of this product. |
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