OSSTEM OneGuide Keyless Guided Surgery Kit User Manual

: June 13, 2024
: OSSTEM

Table of Contents

Description about the product
Precautions
References
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OneGuide KIT
User Manual

Storage Condition :
Dry place at room temperature (1°C~30°C)
Caution, Consult accompanying Documents
OBELIS S.A.
Bd. Général Wahis, 53 1030 Brussels, Belgium
Tel: +32.2.732.59.54

Description about the product

OneGuide KIT provides a surgical guide for the fixation of an implant to the desired site using the OneGuide Template.
OneGuide KIT is composed of a Tissue Punch to remove soft tissue, a Flattening Drill to flatten uneven bone surfaces, an Initial Drill to form the first drill hole, a Taper Drill optimized for the shape of a taper implant, and a driver to fix the implant.
OneGuide KIT is a surgical KIT for implants with simple surgery, providing sequences that enable the fixation of implants with only 2 to 4 drilling steps.

Indications for use
It is used for the treatment of dental implants.

Directions to use and procedure

Place the pre-made OneGuide Template in the patient’s mouth.
Check the compatibility between tooth and OneGuide Template.
Once compatibility is confirmed, all the remaining surgical procedures can be performed once the OneGuide Template is fixed.
Remove the soft tissue from the site for implant fixation using the Tissue Punch (800~1,200 RPM).
Flatten the bone surface by using the Flattening Drill (1,200 RPM).
Perform drilling by using the Initial Drill (800~1,200 RPM).
Perform drilling with the surgical method appropriate for the dimensions of the implant to be fixed and bone quality using the Taper Drill (800~1,200 RPM).
Fix the implant using the NoMount Driver, in which the direction of implant hex needs to be aligned by matching the groove of driver with the OneGuide Template.
Adjust the final depth of fixation by connecting the Implant Driver to the Torque Wrench. The direction of the implant hex needs to be aligned by matching the groove of driver with the OneGuide Template.
After surgery, remove the OneGuide Template from the mouth, and then follow the general implantation procedure for the rest of the steps.

Precautions

Completely familiarize yourself with the manual before operation.
This product is a medical device. Users must follow the sterilization protocol below before use.

OneGuide Template: Low-temperature sterilization (Do not use autoclave or hydrogen peroxide.)
Other components: autoclave (Temperature: 132°C, Time: 15 minutes)

Caution in Use

Only dentists are allowed to use this product. Do not use this product for other than the intended purpose.
Carefully inspect the product for any problem in external appearance or if it has been dropped on the floor. If there are any issues, then replace it with a new one.
In order to prevent the OneGuide Template from being damaged, exercise caution to avoid loading excessive force during drilling.
Be sure to spray saline solution during to reduce the friction heat with the bone.
The recommended number of use for the drill and the driver is 50.

Caution after Use

Separate all used tools immediately after surgery. Store at room temperature after cleaning and drying.
Do not leave the instruments in a place vulnerable to contamination.
OneGuide Template is a disposable, non-sterile medical device and cannot be reused.
The warranty period for this product is 1 year after purchase.

Side Effect
A few problems may occur after the operation (loss of implant stability, damage of prosthesis, etc.). Deficient quality and quantity of the remaining bone, infection, allergic reaction, inferior oral hygiene or uncooperativeness of patient, implant mobility, partial deterioration of tissue, and improper position or arrangement of implants may cause the above mentioned problems.
Product Information
The product name, specifications, manufacturing date, and product Lot are indicated on the package label.
For further details, refer to the OneGuide catalog and surgical manual provided by the salesman. For general information on implant, refer to the catalog and prosthesis manual.

| Caution| | Manufacturer
---|---|---|---
| Catalogue Number| | Made in Korea
| Batch code| | Instructions: refer to manual
| Date of Manufacture| | Quanity

OBELIS S.A.
Bd. Général Wahis, 53 1030 Brussels, Belgium
Tel: +32.2.732.59.54

Manufacturer
OSSTEM IMPLANT Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea
TEL : 82-51-850-2500
FAX : 82-51-861-4693
http://www.osstem.com