Boehler Bone Gouge Forceps - Helmut Zepf (42.646.15) - Delynov Oral Surgery - Delynov
The Pince-Gouge Boehler - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 42.646.15.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Boehler Helmut Zepf bone rongeur?
The Boehler bone rongeur, referenced under code 42.646.15, is a specialized manual instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This high-precision device is manufactured from medical stainless steel, a standard material for surgical instrumentation ensuring resistance adapted to the stresses of bone surgery. As an instrument in the GBR (Guided Bone Regeneration) category, its structure is optimized for the manipulation of hard tissues. This device belongs to Class I according to the regulatory classification of medical devices, ensuring its compliance for professional use in dental practices or hospital environments.
What are the clinical indications for this instrument?
This oral surgery bone rongeur is primarily indicated for interventions requiring modification of the bone architecture. It is used by dental surgeons and implantologists for the resection of prominent alveolar ridges, the removal of bone spicules after extraction, or the modeling of exostoses. Its use is common during pre-implant preparation phases or corrective periodontal surgery. The instrument allows for controlled bone removal, thus facilitating the placement of membranes or the adjustment of prostheses. Its application is strictly reserved for healthcare professionals trained in oral surgery techniques.
What are the technical characteristics of the 42.646.15 forceps?
The Boehler bone rongeur from Helmut Zepf is distinguished by its robust design in medical stainless steel, specifically selected for its mechanical properties. Although exact dimensions are not specified, its technical reference 42.646.15 corresponds to a standard Boehler model in the manufacturer's catalog. The instrument is delivered non-sterile, which requires a rigorous preparation protocol before the first use and between each patient. The product design and materials used do not allow for a defined maximum limit of processing cycles, but the user must check for the absence of visible damage, such as cracks or defects on the cutting edges, before any intervention.
What are the contraindications for the use of this device?
The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity to the components of the instrument. Metal intolerance in the patient, particularly to medical stainless steel, can trigger adverse reactions upon contact. If a hypersensitivity reaction is observed during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. Additionally, the use of the instrument is strictly contraindicated if it shows visible signs of wear, breaks, or damaged cutting edges, as this could compromise patient safety and the effectiveness of the surgical procedure.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must imperatively follow a complete cycle of cleaning, disinfection, and sterilization before the first use and after each subsequent use. It is crucial to clean each product to remove any residue before autoclaving. The practitioner must carefully inspect the instrument to detect any cracks or deformations. Due to the nature of the materials and the design of the rongeur, there is no predefined limit for reprocessing cycles, but durability depends directly on compliance with maintenance instructions. The use of damaged or worn products is formally prohibited to guarantee asepsis and the precision of the operative procedure.
Who is the manufacturer and what standards are respected?
The Boehler bone rongeur is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with European regulatory requirements relating to medical devices. The product is classified as Class I, which corresponds to reusable surgical instruments that do not present a high risk. Compliance with manufacturing standards guarantees that the medical stainless steel used meets the expectations for biocompatibility and resistance necessary in oral surgery. Each instrument is identified by a precise technical reference, allowing full traceability within the care chain, in accordance with the Medical Device Regulation (MDR) directives.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Helmut Zepf |
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