CSM Implant System Instructions for Use

Precautions

Surgical technique for endosseous dental xture implant requires special and complex procedures. Formal training for xture placement is recommended. Important : Determine local anatomy and suitability of the available bone for xture placement. Thorough screening of prospective xture must be performed. Panoramic and periapical radiograph for visual inspection are essential to determine anatomical landmarks, occlusal condition, periodontal status and adequacy of bone. Lateral cephalometric radiographs, computerized axial tomograghy and tomogram could be instructive. Appropriate radiography, direct palpation and visual inspection of the xture site are necessary for planning or treatment prior to use xtures.

Directions for use

The surgical procedure should be done under aseptic condition with specially designed sterile surgical instruments. The sterilized implants have to be delivered precisely from package to preparation site. An electrical surgical drilling system with internal or external irrigation is recommended. Prescribed drilling sequences (Guide drill Pre-nal drill - Final drill) or combination of surgical tools with 70Ncm torque power should be followed to make a hole in the jawbone and to place a xture. In case of Hard Bone(D1) please use CSM D1 Drill or the drill of next diameter. Parallel Pin is used for measuring the direction and the depth of the hole. Fixture in the ampul should be placed up by using Mountless Driver and be planted into the bone. Handpiece or Ratchet Wrench is usable to plant. Insertion depth of CSM xture shall be 0.2mm below than the bone level. When the xture is fully seated, carefully remove Mountless Driver and place Cover Screw or Healing Abutment on the xture. Then close tissue ap and suture it. The healing period will be 45~90days for lower jaw, 90~180days for upper jaw. (Don't lost balance in drilling work during operation)

Usage and Storage

• This product is disposable.
• It should not be reused.
• All the product package should be stored at low humidity and room temperature condition

Caution

• Surgical Complications : Implant procedure has risks such as localized swelling, dehiscence, temporary pain, edema, hematoma or bleeding. Numbness of the lower lip and jaw after mandible surgery and tissue beside the nose after maxilla surgery is a possible side-eect. It is a temporary nature, though the numbness lasts permanently very rarely. Gingival-mucosal (gum tissue) ulceration, tissue reaction, or infection may occur but it generally responds to local care.
• After the procedure of implant treatment could be found swollenness of a specic part, rupture, temporary palpate sensitiveness, an edema, hematoma, bleeding.
• Insensibility of lower jaw and lip, some side eects relating around the nose from maxillary sinus treatment may occur that is mostly temporary but rarely permanent paralysis could appear.
• Contraindications : Fixture should not be placed in case where the remaining jaw bone is too diminished to provide adequate width and height to surround the implant. Lack of osseointegration or subsequent implant failure may occur in cases insucient bone available, poor bone quality, poor oral hygiene, heavy smoking, or under medical conditions such as blood disorders, infected HIV virus or uncontrolled diabetes.
• Warnings (Wornings for possible side eects from the usage of medical devices) : As xture surgery and dental restoration involve complex surgical procedures, for safe and eective use of xtures, specialized training is strongly suggested. Improper patient selection and technique can cause the xture failure and/or loss of supporting bone. Wobble of xture, bone loss, or chronic infection may cause xture failure. If the xture becomes contaminated by the patients body uids in any way, the xture cannot be used in other patient. Do not splint or bridge with natural tooth. Excessive force on the xture will cause metal fatigue and can cause xture fracture. Single stand or by xtures are recommended.
• Interaction : Dental xtures are designed only for its use and must not be altered and converted in any way. The use of electro-surgical or laser surgical instruments around metallic xtures and their abutments is not recommended due to the risk of electric shock and/or heat burn.
• Usage for the aged or a pregnant woman : The aged, a pregnant woman, growth phase, an obese patient or a patient who had other case history shall be considered to perform an operation.
• Warnings for application : A surgeon shall be followed instruction of the procedure for high success rate of implant surgery. Advert to not damage on nerves, diagnose concavity on lingual side of the submaxillary bone for preventing perforation of the submaxillary bone. Do not put over torque for preventing bone crack. • Caution of safety accidents : Take any possible stus away as combustibility materials or unsterilization devices from a patient and a surgeon.