DRILL. INTERNAL DIAMETER 5.0 MM - Helmut Zepf (08.910.13F) - Delynov
The TREPAN. DIAMETRE INTERNE 5.0 MM - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class IIa.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 08.910.13F.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 5.0 mm trephine?
The Helmut Zepf trephine, bearing reference 08.910.13F, is a surgical rotary instrument designed for the precise circular cutting of bone tissue. This surgical trephine features an internal diameter of 5.0 mm, allowing for standardized bone core drilling. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is intended for professional use in oral and implant surgery. Its structure is optimized to fit onto a surgical contra-angle in order to perform cylindrical block harvesting or to facilitate the removal of osseointegrated implants.
What are the clinical indications for the bone trephine?
This bone trephine has two main indications according to data from the manufacturer Helmut Zepf. Firstly, it is used for harvesting cylindrical bone blocks from the jaw. These bone cores can then be used as-is for onlay grafts or inserted into a bone mill for further treatment prior to filling. Secondly, the instrument is indicated for the explantation of implants. By choosing a diameter adapted to the implant to be removed, the practitioner can clear the periphery of the implant screw to allow its removal during complications or implant failures.
What are the technical and handling characteristics?
This 5mm trephine drill (internal diameter) must be attached to a contra-angle. To obtain bone blocks, the manufacturer recommends setting the motor at a speed between 800 rpm and the maximum authorized by the device. For implant explantation, the recommended speed is between 800 rpm and 1000 rpm maximum. The drilling or milling process must be performed with continuous in-and-out movements. Abundant irrigation with sterile physiological saline solution is mandatory, either manually or via the contra-angle cooling system, to avoid thermal overheating of the tissues.
What are the contraindications and precautions for use?
Although the manufacturer does not list specific medical contraindications related to the material, strict handling precautions apply. Excessive pressure must not be exerted during treatment. It is crucial not to stop the motor while the trephine is inside the surgical cavity; a premature stop can prevent the removal of the instrument or cause it to break. Use is strictly reserved for qualified healthcare professionals. The practitioner must choose the trephine diameter based on the diameter of the desired tissue block or the implant to be extracted to ensure the safety of the procedure.
What are the precautions related to the product life cycle?
The Helmut Zepf trephine is classified in the category of reusable consumables according to appropriate processing protocols. The manufacturer states that there can be no defined maximum limit for the intended use, but the achievable processing cycles must be determined by the professional. The instrument must be inspected before each use to check its integrity. Abundant and continuous rinsing during the surgical act is essential to maintain cutting performance and the viability of surrounding tissues. Compliance with motor speed parameters (800 to 1000 rpm depending on the act) is a key factor for the longevity of the instrument.
Who is the manufacturer and what standards are met?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This trephine is a Class IIa medical device according to current regulations. As a Helmut Zepf product, it benefits from the expertise of a manufacturer recognized in high-precision surgical instrumentation. Compliance with cleaning, disinfection, and sterilization protocols is necessary between each patient, in accordance with the manufacturer's instructions for devices of this regulatory class, to guarantee clinical safety and compliance with medical sector requirements.
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Specifications
| Manufacturer | Helmut Zepf |
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