XVT tissue level

instructions

INSTRUCTIONS FOR Xcem Elite (XE)

Purpose of product

This product use an artificial tooth root inserted into the upper or lower alveolar bone in dental implant surgery.It is a disposable sterilized medical device.

1. Cautions of use

–           General cautions

• Use only skilful dentist, use only one time.
• Check the term of validity and the package condition.
• The implantation procedure should be done under aseptic condition, care for contamination.
• Surgery, dentist and dental technician make a surgical plan by discussing to accurate examination of patient’s condition.
• Care for pyrexia and injury.

–           Cautions of use

• The accompanying label for medical treatment should be used for care of patient.
• Maximize revolutions per minute of Torque Controlled Hand – piece is 1.5.
• Recommended torque is 10N/cm² when connecting healing abutment or cover screw.
• Cleaning around surgery part.
• After surgery, supply surgery part with saline.
• Must not use except mentioned purpose.

–           Cautions during healing period

• Cleaning oral for saline.
• Let him bite the gauze for control bleeding during 1 hour
• Check a mucous membrane every 3-4 week after insertion and check a panorama before connection abutment.
• To avoid inflammation and infection, proper maintenance on hygiene of oral is essential.
• Educated on prevent of overpressure in healing period.

2. Contraindications

–           Intra-oral contraindications

Inappropriate inter-occlusal relationship (insufficient bone quantity), problematic occlusion or functional relationship, pathologic condition of alveolar bone, radiation therapy on alveolar bone, xerostomia, pathologic change of oral mucosa (Leukoplakia, lichen planus, stomatitis), Macroglossia, Unrestored tooth, poor oral hygiene.

–           Contraindications that is transiently limited

Acute inflammatory disease and infection, pregnancy, temporary medication of specific medicine (Anticoaggulant, immunodepressive), physical or mental stress.

–           Mental contraindications

Patients with poor cooperation, alcohol and drug abuse, neurotics, patients with mental illness.

–           General medical contraindications

Current medication (corticosteroid, long term antibiotic treatment), metabolic disorder (juvenile diabetes, blood sugar level – higher than 300), Hemotologic disorder (RBC, WBC, Coaggulation system disorder), metabolic disorder of bone (Osteomalacia , osteitis deformans, osteogenesis imperfecta, menopausal osteoporosis), Collagen disorder (Dermatosclerosis, rheumatic arthritis), implant as focus of potential bacterial growth (Artificial heartvalve, bacterial endocarditis).

3. Side effects

Dehiscence, delayed healing, Paresthesia, Hyperesthesia, Edema, Hemorrhage, Hemotoma, Infection, Inflammation, allergy.

4. Directions

–           Matters to prepare before use

• Open package after checking package condition and expiration date before use of product, and use it in surgery after checking any damage or problem of product.
• Dentist should fully understand operation sequence and direction by using surgical instrument of the product before clinical use.
• Prepare to sterilized surgical instrument for surgery (121°C x 30min : Autoclave)
• Surgery, dentist and dental technician make a surgical plan by discussing to accurate examination of patient’s condition.

–             Directions for use

• Open outer box after checking information of label. First check instruction for use.
• Remove packaging film.
• Open cap of inner ampule, pull out carefully inserted fixture.
• Hold on cap of inner ampule and placed hand-piece or rachet wrench of connected fixture driver on inner hexa or octa of fixture.

And then tilt a fixture open side, broke a bottom neck of fixture.

• Assigned range of torque should apply when fastening screw of abutment. And completely cleaning around implant after connected abutment in fixture.

5. Storage and handling after use

Use only one time. Do not reuse.

6. Healing period after inserted implant
7. Patient should be informed of matters that require attention until next appointment.
8. Let the patient visit every week 3 ~4 weeks during healing period.
9. A stitch out is done after 8 ~9 days and surely checks infection or remained suture
10. Preservation

• 12°   ~ 28° and 0   ~ 80% in cold shade and well ventilation room.
• Avoid in room of chemicals storage, gas issues and fearing infection.
• 3 years if not opened after sterilization.