TREPHINE. INNER DIAMETER 7.0 MM - Helmut Zepf (08.910.09S) - Delynov
The TREPAN. DIAMETRE INTERIEUR 7.0 MM - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class IIa.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 08.910.09S.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 08.910.09S trephine?
The Helmut Zepf trephine, bearing reference 08.910.09S, is a specialized rotary surgical instrument. This device features an internal diameter of 7.0 mm, designed for oral surgery procedures requiring precise circular cutting of bone tissue. Manufactured by Helmut Zepf Medizintechnik GmbH, this tool is primarily used for the creation of cylindrical bone blocks. Its structure allows for controlled penetration into the jaw to extract bone cores intended to be repositioned or further processed. It is a robust instrument meeting the requirements of implantology and bone reconstruction protocols.
What are the clinical indications for this 7.0 mm trephine?
The clinical indications for this Helmut Zepf trephine primarily include the harvesting of autogenous bone blocks from the jaw. These cylindrical blocks can be used directly as grafts at another surgical site or inserted into a bone crusher for additional processing. Another major indication is the explantation of implants. In this case, the practitioner selects the trephine based on the diameter of the implant to be removed in order to perform peripheral drilling, allowing the implant to be freed from its bone anchorage with minimal peripheral tissue loss.
What are the technical characteristics and operating parameters?
The Helmut Zepf trephine with an internal diameter of 7.0 mm must be attached to a suitable contra-angle handpiece. To obtain bone blocks, the motor must be set to a speed between 800 rpm and an unspecified maximum, although for explantation, the recommended range is 800 rpm to 1000 rpm maximum. The drilling or milling process must be performed using continuous in-and-out movements. Abundant irrigation with sterile physiological saline solution is imperative, either manually or via the contra-angle's cooling system, to prevent any thermal overheating of the tissues.
What are the contraindications for the use of this instrument?
The manufacturer Helmut Zepf does not list specific medical contraindications in the technical documentation provided for this Class IIa device. However, the use of this instrument requires a prior clinical evaluation of the bone density and volume available at the harvesting site or around the implant to be explanted. The practitioner must ensure that the 7.0 mm diameter is appropriate for the patient's anatomy and the surgical objective to avoid damaging adjacent anatomical structures, such as nerves or sinuses, during the drilling process.
What precautions should be taken during surgical handling?
When using the trephine, excessive pressure must never be applied to the bone. It is crucial not to stop the motor while the trephine is inside the surgical cavity. Prematurely stopping the motor could prevent the removal of the instrument or, in the worst case, cause it to break inside the operative site. Irrigation management is also a critical factor: rinsing must be continuous and abundant to ensure the viability of the harvested bone cells and the safety of the recipient site. Compliance with the rotation speeds recommended by Helmut Zepf ensures the longevity of the tool.
Who is the manufacturer and what standards are met?
This trephine is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device is classified as Class IIa according to current regulations, which attests to its compliance with safety and performance requirements for invasive surgical devices for temporary use. Following cleaning, disinfection, and sterilization protocols is essential to maintain the quality standards of the Helmut Zepf brand and ensure patient safety during every oral or implant surgery procedure.
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Specifications
| Manufacturer | Helmut Zepf |
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