Trephine. Internal Diameter 9.0 MM - Helmut Zepf (08.910.11)
The TREPAN. DIAMETRE INTERNE 9.0 MM - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class IIa.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 08.910.11.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 9.0 mm bone trephine?
The bone trephine from the brand Helmut Zepf (reference 08.910.11) is a surgical rotary instrument specifically designed for cutting hard tissues. This device features an internal diameter of 9.0 mm, allowing for the creation of calibrated cylindrical bone samples. Manufactured by Helmut Zepf Medizintechnik GmbH, this tool is classified as a Class IIa medical device according to current regulations. Its hollow structure is optimized for the recovery of autogenous bone cores while minimizing loss of substance during drilling. It is intended to be mounted on a surgical contra-angle for use in implantology and oral surgery.
What are the clinical indications for this 9mm trephine?
This 9mm trephine has two major indications in oral surgery. First, it is used for creating cylindrical bone blocks harvested from the jaw. These cores can be used as they are for onlay grafts or transferred to a bone mill to obtain particulate filling material. Secondly, this instrument is indicated for the explantation of dental implants. In this context, the practitioner chooses the trephine based on the diameter of the implant to be removed in order to clear the periphery of the implant and facilitate its extraction while maximally preserving the surrounding bone.
What are the technical and handling characteristics?
Technical characteristics require a strict protocol to guarantee cutting efficiency and patient safety. For obtaining bone blocks, the trephine must be attached to a contra-angle with a motor set to a speed between 800 rpm and the maximum authorized by the manufacturer. For implant explantation, the recommended speed is between 800 rpm and 1000 rpm maximum. The drilling or milling process must be carried out with continuous insertion and extraction movements. It is imperative to use abundant irrigation with sterile physiological saline solution, either manually or via the contra-angle's irrigation system.
What are the contraindications for the use of this instrument?
Although the manufacturer Helmut Zepf Medizintechnik GmbH does not list specific pathological contraindications in the provided data, the use of this trephine is strictly reserved for qualified healthcare professionals. A major technical contraindication lies in the application of excessive pressure during drilling, which could compromise the integrity of the bone or the instrument. Furthermore, it is formally advised not to stop the motor as long as the trephine is inside the surgical cavity. A premature stop can prevent the removal of the instrument or cause it to break, leading to operative complications.
What are the precautions for use and processing?
Maintaining the performance of the 9mm trephine drill depends on its handling. During surgical treatment, constant irrigation is necessary to avoid thermal overheating of the bone tissues. After use, the device must undergo appropriate processing cycles (cleaning and sterilization). The manufacturer specifies that there is no defined maximum limit for processing cycles, but these must be determined by the user based on observed wear. It is essential to check the condition of the cutting edges before each intervention to ensure a clean and precise cut.
Who is the manufacturer and what standards are respected?
The trephine is manufactured by Helmut Zepf Medizintechnik GmbH, headquartered in Seitingen-Oberflacht, Germany. This recognized manufacturer in the dental instrumentation sector ensures the compliance of its products with European regulatory requirements. This medical device is listed as Class IIa (MDC0483), which guarantees a high level of control for invasive surgical instruments for temporary use. Compliance with the rotation speed and irrigation protocols recommended by Helmut Zepf is essential to maintain the device's conformity during its clinical use in dental offices or hospital settings.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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