Neobiotech
X Dental Supplies : Excellence, Experience and Expertise
User Guide for X DENTAL models including: FR315, FR320, FR415, FR420, FR515, FR520, FR615, FR620, HDF1607, HDF1612, HDF1617, FR315 Series Fixture Removal Kit, FR315 Series, Fixture Removal Kit, Removal Kit
Fixture Removal Kit – X Dental Supplies
File Info : application/pdf, 16 Pages, 1.66MB
DocumentDocumentRev.2 08/2015-E
Neo FR Kit User Guide
Rev.2 08/2015
Product description
This product is a fixture remover kit consisting of dental implant surgical tools (drills, surgical tools, drivers) manufactured from medical device materials such as stainless steel.
Fixture Remover FR Screw Hex Driver
Fixture Remover Screw
Torque Control Device
Intended use
This product is a surgical tool designed to remove implants that were stopped during the implantation due to excessive torque or implants whose surrounding bones have been damaged. After removing the implant, a new implant with the same diameter can be immediately implanted.
Preservation
Store at room temperature in a dry location away from direct light.
How to Prepare Before Use
1 Prior to using this product, the clinician must completely understand the condition, performance, and function of the product.
2 Use only after raising any doubts and verifying any issues with the manufacturer.
3 For the procedure, a plan must be first established, based on checking the patient's oral condition and accurate judgments.
4 After taking into consideration the condition of the patient, tools appropriate for the procedure must be prepared.
NB-FRK-IFU-001
Rev.2 08/2015
Components
1 Fixture Remover This is used in combination with a fixture remover screw, and is used to remove the implant by directly applying removing torque
Narrow Regular Wide (Ø5) Wide (Ø6~8)
Product Name FR315 FR320 FR415 FR420 FR515 FR520 FR615 FR620
Length 15mm 20mm 15mm 20mm 15mm 20mm 15mm 20mm
2 FR Screw Hex Driver
This is used when the fixture remover screw needs to be affixed to, or removed from, the implant.
Product Name HDF1607 HDF1612 HDF1617
<HDF1617 is used when removing the FR screw from the fixture remover>
Length 7mm 12mm 17mm
FR Screw Hex Driver(17mm)
Fixture Remover
Fixture Remover Screw NB-FRK-IFU-001
Rev.2 08/2015
3 Fixture Remover Screw
This is connected to the screw hole inside the implant to be removed. It is connected to the implant and the fixture remover to allow the implant to be removed.
Product Name
Screw size
FRS14
M1.4
FRS16
M1.6
FRS18
M1.8
FRS172
1-72UNF
FRS20
M2.0
FRS25
M2.5
4 Torque Control Device
* "M" means a metric screw, and the number stands for the size of the external diameter of the screw
This can be used by connecting the fixture remover or the FR screw hex driver. It is used to apply to, or measure from, the connected surgical tool an exact amount of torque.
Product Name
Screw size
TW80400
80Ncm/400Ncm
Instruction for use
1 Before using the surgical tool, sterilize and disinfect the components based on our recommended steam sterilization conditions.
2 Completely remove the prosthesis connected to the implant that needs to be removed.
3 After selecting the fixture remover screw that is the appropriate size for the size of the screw hole inside the implant that needs to be removed, connect it to the FR screw hex driver and apply a torque of 40~80Ncm to the implant. (Figures 1, 2)
Figure 1
Figure 2
<Fixture remover screw Guide Torque>
Screw
Spec.
Recommended Torque (Ncm)
Screw
FRS14
M1.4
60
FRS172
FRS16
M1.6
80
FRS20
FRS18
M1.8
80
FRS25
* Recommended tightening torque according to the Fixture remover screw size is as follows
Spec. 1-72UNF
M2.0 M2.5
Recommended Torque (Ncm)
80
80
80
NB-FRK-IFU-001
Rev.2 08/2015
4 Rotate the fixture remover connected to the fixture remover screw attached to the implant in a counterclockwise direction as far as possible then, using the torque control device, apply torque in the removal direction (counterclockwise) until the implant rotates. (Figures 3, 4)
Figure 3
Figure 4
* The maximum torque based on the fixture size is as follows
<Fixture removing torque>
Fixture Size
Remover
Screw FRS14
Maximum Torque(Ncm)
200
FRS16
250
Narrow
FR315 or FR320
FRS18 / FRS172
300
FRS20
350
FRS18 / FRS172
300
FR315 or FR320
FRS20
350
Regular
FRS18 / FRS172
300
FR415 or FR420
FRS20
350
FRS20
350
FR415 or FR420
FRS25
400
Wide (Ø5)
FRS20
350
FR515 or FR520
FRS25
400
FRS20
350
FR515 or FR520
FRS25
400
Wide (Ø6~8)
FRS20
350
FR615 or FR620
FRS25
400
NB-FRK-IFU-001
Rev.2 08/2015
5 Optional procedure If the implant cannot be removed even after the fixture removing torque has been applied, remove the fixture remover from the implant and, using the round bur, remove a minimum amount of the bone surrounding the upper part of the implant. Then retry the step "number 4." (Figures 5, 6)
Figure 5
Figure 6
6 Attach a vise to the lower part of the removed implant (Figure 7). After connecting the torque control device to the fixture remover, rotate clockwise in order to separate from the implant. (Figures 8, 9)
Figure 7
Figure 8
Figure 9
Separate all of the fixture remover screws connected to the removed implant by rotating them counterclockwise, using the FR screw hex driver. (Figures 10, 11)
Figure 10 <Fixture removing mimetic diagram>
Figure 11
Clamping Force
Clamping Force
Failed implant
Right turn Close
Left turn Close
Clear
NB-FRK-IFU-001
Rev.2 08/2015
Precaution for use
1 The product must be used only after the user becomes completely familiar with the proper methods of use.
2 When selecting the size of the fixture remover screw, the precise size of the screw hole inside the implant that needs to be removed must be verified. If not, incomplete fixation of the fixture remover screw to the implant may cause the screw to become damaged or fractured before the implant can be removed (If a fixture remover screw is used that is too small for the size of the screw hole inside the implant, connection can be forced. Accordingly, when the proper size is unknown, start from the largest size fixture remover screw and go down until the proper size fixture remover screw to connect is selected.)
3 When selecting the size of the fixture remover, it is recommended that a size bigger than the diameter of the upper part of the implant be selected. If a smaller size is used, it may not be able to properly receive the removing torque, making it difficult to remove the implant.
4 When affixing the fixture remover screw, it must be affixed using the recommended amount of torque. If not, the fixture remover screw may fracture, bend, or it may simply rotate between the implant and the fixture remover.
5 A fixture remover screw and fixture remover must be used one time only as the fixture remover screw and fixture remover may bend or fracture if reused. Accordingly, reuse is prohibited.
6 When the maximum removing torque is exceeded in the course of using the fixture remover, there is a risk that the surgical tool will be damaged, or the implant will be shattered or bone fractured. Accordingly, caution should be taken not to exceed the maximum removing torque.
7 If 60 Ncm or a higher amount of torque is applied when removing the implant, the implant must be removed with adequate irrigation in order to prevent any overheating.
8 When using the torque control device together with surgical tools, if torque is applied before they are completely connected, the product performance may be reduced or the product may be damaged. Accordingly, use only after they are properly connected. (Such as a fixture remover, or FR Screw hex driver)
How to Sterilize
1 Because the product is a non-sterilized medical device, select either a pre-vacuum or a gravity autoclave. (Plastic products must not be sterilized at or above 170°C (338°F)
2 Before sterilization, the inner wrapper must be removed from the tray. Assembled components must be separated in order to improve the efficiency of sterilization.
NB-FRK-IFU-001
Rev.2 08/2015
3 Using surgical wrap, wrap the tray, seal with autoclave tape, and sterilize.
<Recommended Steam Sterilization Conditions >
Cycle Type
Temperature
Pressure
Exposure Time
KIT, Instrument
Pre-vacuum¹²
132 270 °F
2 bars 28.5 psi
3 minutes
Dry Time 30 minutes
KIT, Instrument
Gravity¹
121 250 °F
1 bars 14.5 psi
40 minutes
30 minutes
In order to effectively carry out high-pressure steam sterilization, the use of biological indicators at a regular interval must be considered. (Dry heat sterilization or chemical sterilization is not recommended.)
Minimum time and temperature conditions for steam sterilization to reach the sterilization guarantee level of 10-6 If regional or national sterilization requirements are stricter than the conditions provided above, they must
be followed.
If the above sterilization conditions are exceeded, it is possible that the plastic and components may be damaged. The sterilization device must be adjusted to ensure that the recommended temperatures are not exceeded.
How to Wash after Use
Surgical Tools
1 After the procedure ends, detach all surgical tools from the tray, soak them in alcohol, and rinse them using conventional means.
2 After washing by using distilled water or flowing water and rinsing, remove any traces of blood or foreign objects remaining. Use a syringe or pipe cleaner for areas that are difficult to wash.
3 Following the instructions of the cleaner manufacturer, dilute the enzyme cleaner using tap water and, after ten minutes of ultrasound washing, rinse using tap water for three minutes.
4 Completely remove the moisture using a dry cloth or a warm-air circulator. KIT Tray
1 Remove all visible foreign objects using distilled water or flowing water and a soft brush. For areas that are difficult to clean, use a syringe or pipe cleaner.
2 Following the instructions of the cleaner manufacturer, dilute the enzyme cleaner using tap water and soak for one minute. Afterwards, using a soft brush, remove any foreign objects remaining on any part.
3 After washing, rinse for three minutes using tap water to remove the remaining enzyme cleaner.
4 Completely remove the moisture using a dry cloth or a warm-air circulator.
5 Organize the dry surgical tools in the kit case and sterilize, following the sterilization procedure. (At this time, refer to the colors to make the setup easy.)
NB-FRK-IFU-001
Rev.2 08/2015
How to Store and Maintain after Use
1 All surgical tools that were used must be immediately detached, washed, and dried, after the procedure, then stored at room temperature.
2 Do not store in a soiled area or where there is a risk of infection. 3 This product is a non-sterilized medical device. Accordingly, it may be used only after
sterilizing in an autoclave before and after any procedure. (See How to Sterilize)
Precaution
1 Only dentists who have completed implant procedure education and training courses can use this product.
2 For each patient, a procedure plan must be established, based on a treatment plan after testing and analyzing for whole-body ailments, infectious disease, whether they are receiving treatment for other ailments, and whether there is any oral lesion.
3 The surgeon must use the product only after becoming completely familiar with how to use the product and the relevant warnings, and must select products that fit the treatment plan.
4 Before each procedure, the tools must be examined for wear and tear. 5 Any external contact with the surfaces is prohibited. 6 Improper selection of the patient or procedure may cause failure of the implant or post-
surgical bone loss around the implant. 7 Hydrogen peroxide is prohibited for disinfection and washing, as it could damage or dis-
color the TIN coating, laser markings, or colors.
Contraindication
1 Patients with serious internal ailments: endocrinal ailments such as diabetes or hypertension, circulatory ailments, and ailments related to the blood, organ, or immune systems.
2 Patients receiving high-level radiation treatment for malignant tumors or other reasons. 3 Patients who have unsuitable jaw relations or problematic occlusions. 4 Patients with dry mouths. 5 Patients with unrestored teeth who maintain bad oral health conditions. 6 Patients with acute inflammatory ailments and patients who are at risk of infection. 7 Pregnant patients. 8 Smokers. 9 Patients with blood clotting conditions or with severe cardiac ailments. 10 Children aged 16 years or younger. 11 Patients who are allergic to titanium or stainless steel. 12 Patients without ordinary wound-healing function.
NB-FRK-IFU-001
Rev.2 08/2015
13 Patients who are taking other drugs. 14 Patients who are vulnerable to physical and mental stress due to temporary use of a spe-
cific medication. 15 Patients who are emotionally unstable, such as due to alcohol addition, drug abuse, neuro-
logical ailments, or mental ailments. 16 Patients who have unrealistic expectations regarding the treatment.
Side effect
1 Using surgical techniques in a skillful manner minimizes the occurrence of complications. 2 Paresthesia due to nerve damage or malocclusion, infection, edema, hypodermic bleed-
ing, pain, or opening of the sutures, ulcer in the soft tissues, and other localized adverse reactions may occur. 3 Localized and general allergic reactions.
Label Symbols
Symbol
Definition
Catalog Number
Symbol
Batch Code
Date of manufacture
Definition Consult instruction
for use
Sterilized Using irradiation
Prescription Only
Manufacturer
Caution, consult accompanying
documents
Non-Sterile
Do not re-use Do not use if package is damaged
* This product is a non-sterilized medical device.
NB-FRK-IFU-001
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Neobiotech Co., Ltd. E-space #1001, 36, Digital-ro 27-gil, Guro-gu, Seoul, Korea, 08381 Tel. +82 2 582 2885 | Fax. +82 2 582 2883 www.neobiotech.com
X DENTAL SUPPLIES Level 1, 60 Archer Street, Chatswood NSW 2067, Australia Tel. 02 8880 6466 www.xdentalsupplies.com.au