Trephine. Internal diameter 9.0 mm - Helmut Zepf (08.910.11F) - Delynov
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: 08.910.11F.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 9.0 mm trephine?
The Helmut Zepf trephine (reference 08.910.11F) is a surgical rotary instrument designed for precise circular cutting of bone tissue. Featuring an internal diameter of 9.0 mm, this tool is specifically developed for oral surgery interventions requiring the harvesting of cylindrical bone grafts. Manufactured by Helmut Zepf Medizintechnik GmbH, this Class IIa device is integrated into bone reconstruction protocols where sampling calibration is essential for the success of the graft or for subsequent transformation of the harvested tissue.
What are the clinical indications for this instrument?
The main indications include the creation of cylindrical bone blocks obtained from the jaw. These blocks can be used as-is for onlay grafts or inserted into a bone grinder to obtain bone particles intended for other filling techniques. A second major indication concerns the explantation of implants: the trephine allows the implant to be released from its bone anchorage peripherally. The choice of trephine diameter must imperatively be adapted to the diameter of the desired tissue block or to that of the implant to be removed.
What are the technical characteristics and recommended settings?
The 08.910.11F trephine must be attached to a suitable contra-angle (elbow). To obtain bone blocks, the manufacturer Helmut Zepf recommends setting the motor to a speed between 800 rpm and a maximum defined by the device. For explantation procedures, the recommended speed is between 800 rpm and 1000 rpm maximum. The drilling or milling process must be carried out using continuous insertion and extraction movements to optimize cutting and debris evacuation, while avoiding tissue overheating.
What are the contraindications for use?
Although the manufacturer does not list specific pathological contraindications in the documentation provided, the use of this instrument is strictly reserved for qualified healthcare professionals. Use is contraindicated if cooling conditions are not met or if the rotation speed exceeds technical recommendations. It is imperative not to stop the motor while the trephine is inserted in the surgical cavity, as this could block the instrument or cause it to break, leading to operative complications.
What are the precautions for use and handling?
Abundant irrigation with a sterile physiological saline solution is mandatory throughout the duration of the drilling. This rinsing can be manual or coupled to the irrigation system of the contra-angle. The practitioner must ensure not to exert excessive pressure during treatment. It is crucial to maintain motor rotation when removing the trephine from the surgical cavity to prevent any risk of breakage. The number of achievable treatment cycles is not defined by a fixed maximum limit, but depends on the wear observed during the sterilization and use processes.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This is an instrument classified as a Class IIa medical device according to current regulations. As a product intended for invasive surgery, it meets the safety and performance requirements imposed on medical device manufacturers within the European Union. Its design guarantees compatibility with standard cleaning and sterilization processes required for reusable surgical instruments in the odontological environment.
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Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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