CSM Implant drill system
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작성자 최고관리자 작성일 22-08-29 16:30 조회 228회 댓글 0건본문
CSM IMPLANT SYSTEM INSTRUCTION FOR USE (ENGLISH)
1. Intended Use CSM implant System are intended to be placed into the mandible and maxilla bone to support artificial tooth for the functional rehabilitation of mastication.
2.Indication CSM implant System Implants are designed to functional rehabilitation for those with edentulous conditions.
These products can be achieved by 1-stage / 2-stage surgical technique in combination with immediate loading / early loading protocols, having primary stability and outstanding osteointegration.
3. Product Description The CSM Implant System includes a various type and sizes of precision-machined fixtures manufactured
from grade Ⅳ titanium. These implants are surgically inserted into the upper and/of lower jawbone and serve
as a substitute or replacement tooth root providing a stable foundation for restorations.
4. Precautions Surgical technique for endosseous dental fixture implant requires special and complex procedures.
Formal training for fixture placement is recommended. Important : Determine local anatomy and suitability of the available bone for fixture placement. Thorough screening of prospective fixture must be performed.
Panoramic and periapical radiograph for visual inspection is essential to determine anatomical landmarks, occlusal condition, periodontal status, and adequacy of bone. Lateral cephalometric radiographs, computerized axial tomography and tomogram could be instructive. Appropriate radiography, direct palpation and visual inspection of the fixture site are necessary for planning or treatment prior to use fixtures.
5. Directions for use The surgical procedure should be done under aseptic condition with specially designed sterile surgical instruments. The sterilized implants must 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 – Initial drill – Pre-final drill - Final drill – Reamer) or combination of surgical tools.
In case of Hard Bone(D1) please use CSM D1 Drill or the drill of next diameter. 70Ncm torque power is recommended and 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 fixture shall be 0.2mm below than the bone level.
When the fixture is fully seated, carefully remove Mountless Driver and place Cover Screw or Healing Abutment
on the fixture. Then close tissue flap and suture it. The healing period will be 45~90days for lower jaw, 90~180days for upper jaw. (Please be careful not to lose balance in drilling work during operation)
6. 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
7. 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-effect. 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 specific part, rupture, temporary palpate sensitiveness, an edema, hematoma, bleeding.
• Insensibility of lower jaw and lip, some side effects relating around the nose from maxillary sinus treatment
may occur that is mostly temporary but rarely permanent paralysis could appear.
• Contraindications:
a) intraoral contraindication
① inappropriate interocclusal relationship(insufficient bone volume)
② troubled occlusion or function problem.
③ pathogenic conditions of alveolar ridges
④ radiation therapy on the mandible or maxilla.
⑤ xerostomia
⑥ pathogenic change of oral mucosa (leukoplakia, lichen planus, stomatitis)
⑦ macroglossia
⑧ untreated tooth, poor oral hygiene
b) transient contraindication
① acute inflammatory disease and infection
② pregnancy
③ temporary use of specific drugs(anticoagulant, immunosuppressants)
④ physically and mentally stressful state
c) psychological contraindication
① poor cooperation
② alcohol and drug abuse
③ neurosis, mental illness
④ troubled patient
d) medical contraindication
① nutritional condition -age(dyscrasia, obesity)
② drug abuse(corticosteroid, long-term antibiotic therapy)
③ metabolic disorders(diabetes mellitus type 1, over 300)
④ hematologic disorder(red blood cell, white blood cell, coagulopathy)
⑤ cardiac and circulatory illnesses(sclerosis of the arteries, numerical value of hypertension, over 300)
⑥ metabolic disorder of bone(Osteomalacia, osteitis deformans, dysostosis , menopausal osteoporosis)
⑦ collagenous disorder(dermatosclerosis, Rheumation Arthritis)
⑧ Implant of infection focus(artificial heart valve, bacterial endocarditis)
• Warnings (Warnings for possible side effects from the usage of medical devices): As fixture surgery and dental restoration involve complex surgical procedures, for safe and effective use of fixtures, specialized training is strongly suggested. Improper patient selection and technique can cause the fixture failure and/ or loss of supporting bone. Wobble of fixture, bone loss, or chronic infection may cause fixture failure.
If the fixture becomes contaminated by the patient’s body fluids in any way, the fixture cannot be used in other patient. Do not splint or bridge with natural tooth. Excessive force on the fixture will cause metal fatigue and can cause fixture fracture. Single stand or by fixtures are recommended.
• Interaction: Dental fixtures 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 fixtures 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 stuffs away as combustibility materials or non-sterilization devices from a patient and a surgeon.
8. Magnetic Resonance (MR) compatibility and safety information CSM dental implant system has not been evaluated for safety and compatibility in the Magnetic Resonance (MR) environment. It has not been tested for heating, migration, or image artifact in the MR environment.
The safety of the CSM dental implant system in the MR environment is unknown. Scanning a patient who
has this device may result in injury
9. Risk Assessment
Through this data we can encounter some complications.
- Inflammation & Loosening of implant fixture.
9.1 Protection measures For those side-effects, the following solution were recommended
9.2 Application by operators
The CSM Implant is designed for screw type as Branemark and Swiss ITI type, so it is well-known methods to place implant into the bone for prosthetic purpose, CSM dental implant system have two system , screw type and cementation type, also routine procedure of Branemark and Swiss ITI type fixture.
In conclusion, there were no drawbacks in CSM implant system when we compare it with conventional titanium surgical dental implant.
9.3 For abutments supplied non-sterile and intended to be steam sterilized by the user.
Steam sterilize the device in a sterilization pouch for .4 min at 132oC/270o F. Dry abutment for 29 minutes.
9.4 Restriction on device combination in use Do not use other company’s fixture to our CSM Cemented Abutment, or reverse.
Combination with other products: The products are intended for exclusive use within the CSM system;
combination with other implant systems is not indicated .
Warranty: The CSM implant system may only be used according to the manufacturer‘s instructions.
The operator is responsible for ensuring that the product is used for its intended purpose and must also assess whether the product is suited to the patient‘s particular situation. CSM implants may only be used together with CSM products. The CSM warranty is invalidated using third-party products . Liability will not be accepted for products that have been modified, misused, or fitted incorrectly.
9.5. Residual Risk are as follows.
① Marginal bone loss even 5% ;
②Abutment screw fracture.and/or Abutment screw loosening ;
Therefore, for abutment screw loosening from 7~ 19% , abutment screw fracture was 0.6~ 8%..
■ Suitable location Use the fixtures as Small[Ø3.5] for incisor(1,2), Narrow[Ø3.8] and Medium[Ø4.2] for canine(3) and premolar(4,5), Regular[Ø4.6] and Wide[Ø5.3] for molar(6).
4.15 Instructions for use A sample of the instructions for use shall be included in the technical file, containing at least the following information: a) the details referred to in 4.14 with the exception of items c), d) and e); b) the intended use; c) sufficient details of any part connecting to a dental superstructure with which the implant is intended to be employed so as to enable its correct usage; d) where appropriate, the recommended method of opening the pack to ensure sterile presentation at the time of use; e) a detailed description of the surgical and insertion procedure and the use of the parts; f) where appropriate, information on avoiding risks; g) instructions for the procedures to be followed in the event of damage to the sterile packaging and, where suitable, details of appropriate methods of resterilization; h) details of any further treatment or handling needed before the implant or part of an implant system can be used (for example, sterilization, final assembly, etc.); i) contra-indications and known side-effects; j) details allowing professional staff to advise the patient on the precautions to be taken; k) information on possible hazards arising from interactions with medical imaging systems and/or other electromagnetic systems; l) if resterilization is not permitted, the instruction: “Do not resterilize”.
1. Intended Use CSM implant System are intended to be placed into the mandible and maxilla bone to support artificial tooth for the functional rehabilitation of mastication.
2.Indication CSM implant System Implants are designed to functional rehabilitation for those with edentulous conditions.
These products can be achieved by 1-stage / 2-stage surgical technique in combination with immediate loading / early loading protocols, having primary stability and outstanding osteointegration.
3. Product Description The CSM Implant System includes a various type and sizes of precision-machined fixtures manufactured
from grade Ⅳ titanium. These implants are surgically inserted into the upper and/of lower jawbone and serve
as a substitute or replacement tooth root providing a stable foundation for restorations.
4. Precautions Surgical technique for endosseous dental fixture implant requires special and complex procedures.
Formal training for fixture placement is recommended. Important : Determine local anatomy and suitability of the available bone for fixture placement. Thorough screening of prospective fixture must be performed.
Panoramic and periapical radiograph for visual inspection is essential to determine anatomical landmarks, occlusal condition, periodontal status, and adequacy of bone. Lateral cephalometric radiographs, computerized axial tomography and tomogram could be instructive. Appropriate radiography, direct palpation and visual inspection of the fixture site are necessary for planning or treatment prior to use fixtures.
5. Directions for use The surgical procedure should be done under aseptic condition with specially designed sterile surgical instruments. The sterilized implants must 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 – Initial drill – Pre-final drill - Final drill – Reamer) or combination of surgical tools.
In case of Hard Bone(D1) please use CSM D1 Drill or the drill of next diameter. 70Ncm torque power is recommended and 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 fixture shall be 0.2mm below than the bone level.
When the fixture is fully seated, carefully remove Mountless Driver and place Cover Screw or Healing Abutment
on the fixture. Then close tissue flap and suture it. The healing period will be 45~90days for lower jaw, 90~180days for upper jaw. (Please be careful not to lose balance in drilling work during operation)
6. 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
7. 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-effect. 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 specific part, rupture, temporary palpate sensitiveness, an edema, hematoma, bleeding.
• Insensibility of lower jaw and lip, some side effects relating around the nose from maxillary sinus treatment
may occur that is mostly temporary but rarely permanent paralysis could appear.
• Contraindications:
a) intraoral contraindication
① inappropriate interocclusal relationship(insufficient bone volume)
② troubled occlusion or function problem.
③ pathogenic conditions of alveolar ridges
④ radiation therapy on the mandible or maxilla.
⑤ xerostomia
⑥ pathogenic change of oral mucosa (leukoplakia, lichen planus, stomatitis)
⑦ macroglossia
⑧ untreated tooth, poor oral hygiene
b) transient contraindication
① acute inflammatory disease and infection
② pregnancy
③ temporary use of specific drugs(anticoagulant, immunosuppressants)
④ physically and mentally stressful state
c) psychological contraindication
① poor cooperation
② alcohol and drug abuse
③ neurosis, mental illness
④ troubled patient
d) medical contraindication
① nutritional condition -age(dyscrasia, obesity)
② drug abuse(corticosteroid, long-term antibiotic therapy)
③ metabolic disorders(diabetes mellitus type 1, over 300)
④ hematologic disorder(red blood cell, white blood cell, coagulopathy)
⑤ cardiac and circulatory illnesses(sclerosis of the arteries, numerical value of hypertension, over 300)
⑥ metabolic disorder of bone(Osteomalacia, osteitis deformans, dysostosis , menopausal osteoporosis)
⑦ collagenous disorder(dermatosclerosis, Rheumation Arthritis)
⑧ Implant of infection focus(artificial heart valve, bacterial endocarditis)
• Warnings (Warnings for possible side effects from the usage of medical devices): As fixture surgery and dental restoration involve complex surgical procedures, for safe and effective use of fixtures, specialized training is strongly suggested. Improper patient selection and technique can cause the fixture failure and/ or loss of supporting bone. Wobble of fixture, bone loss, or chronic infection may cause fixture failure.
If the fixture becomes contaminated by the patient’s body fluids in any way, the fixture cannot be used in other patient. Do not splint or bridge with natural tooth. Excessive force on the fixture will cause metal fatigue and can cause fixture fracture. Single stand or by fixtures are recommended.
• Interaction: Dental fixtures 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 fixtures 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 stuffs away as combustibility materials or non-sterilization devices from a patient and a surgeon.
8. Magnetic Resonance (MR) compatibility and safety information CSM dental implant system has not been evaluated for safety and compatibility in the Magnetic Resonance (MR) environment. It has not been tested for heating, migration, or image artifact in the MR environment.
The safety of the CSM dental implant system in the MR environment is unknown. Scanning a patient who
has this device may result in injury
9. Risk Assessment
Through this data we can encounter some complications.
- Inflammation & Loosening of implant fixture.
9.1 Protection measures For those side-effects, the following solution were recommended
9.2 Application by operators
The CSM Implant is designed for screw type as Branemark and Swiss ITI type, so it is well-known methods to place implant into the bone for prosthetic purpose, CSM dental implant system have two system , screw type and cementation type, also routine procedure of Branemark and Swiss ITI type fixture.
In conclusion, there were no drawbacks in CSM implant system when we compare it with conventional titanium surgical dental implant.
9.3 For abutments supplied non-sterile and intended to be steam sterilized by the user.
Steam sterilize the device in a sterilization pouch for .4 min at 132oC/270o F. Dry abutment for 29 minutes.
9.4 Restriction on device combination in use Do not use other company’s fixture to our CSM Cemented Abutment, or reverse.
Combination with other products: The products are intended for exclusive use within the CSM system;
combination with other implant systems is not indicated .
Warranty: The CSM implant system may only be used according to the manufacturer‘s instructions.
The operator is responsible for ensuring that the product is used for its intended purpose and must also assess whether the product is suited to the patient‘s particular situation. CSM implants may only be used together with CSM products. The CSM warranty is invalidated using third-party products . Liability will not be accepted for products that have been modified, misused, or fitted incorrectly.
9.5. Residual Risk are as follows.
① Marginal bone loss even 5% ;
②Abutment screw fracture.and/or Abutment screw loosening ;
Therefore, for abutment screw loosening from 7~ 19% , abutment screw fracture was 0.6~ 8%..
■ Suitable location Use the fixtures as Small[Ø3.5] for incisor(1,2), Narrow[Ø3.8] and Medium[Ø4.2] for canine(3) and premolar(4,5), Regular[Ø4.6] and Wide[Ø5.3] for molar(6).
4.15 Instructions for use A sample of the instructions for use shall be included in the technical file, containing at least the following information: a) the details referred to in 4.14 with the exception of items c), d) and e); b) the intended use; c) sufficient details of any part connecting to a dental superstructure with which the implant is intended to be employed so as to enable its correct usage; d) where appropriate, the recommended method of opening the pack to ensure sterile presentation at the time of use; e) a detailed description of the surgical and insertion procedure and the use of the parts; f) where appropriate, information on avoiding risks; g) instructions for the procedures to be followed in the event of damage to the sterile packaging and, where suitable, details of appropriate methods of resterilization; h) details of any further treatment or handling needed before the implant or part of an implant system can be used (for example, sterilization, final assembly, etc.); i) contra-indications and known side-effects; j) details allowing professional staff to advise the patient on the precautions to be taken; k) information on possible hazards arising from interactions with medical imaging systems and/or other electromagnetic systems; l) if resterilization is not permitted, the instruction: “Do not resterilize”.
