Mandibular fixation OBWEGESER. Malleable. - Helmut Zepf (38.465.15)
The Fixation mandibulaire OBWEGESER. Malleable. - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 38.465.15.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf OBWEGESER mandibular fixation?
The OBWEGESER mandibular fixation, referenced under code 38.465.15 by Helmut Zepf, is a malleable manual dental instrument. Manufactured from medical stainless steel, it is designed for oral and maxillofacial surgery interventions. This device is distinguished by its ability to be modeled, thus facilitating its integration during bone stabilization phases. As a Class I instrument, it meets the quality requirements of the manufacturer Helmut Zepf Medizintechnik GmbH, guaranteeing equipment adapted to the needs of operating theaters specialized in implantology and reconstructive surgery.
What are the clinical indications for this mandibular osteosynthesis equipment?
This mandible osteosynthesis equipment is primarily indicated for mandibular fixation during corrective or reconstructive surgeries. Its use is reserved for qualified healthcare professionals. It is used in protocols requiring obwegeser mandibular fixation, where the malleability of the medical stainless steel allows for precise management of bone segments. The instrument is used as a manual support to guide or maintain structures during the placement of definitive osteosynthesis material or during the reduction of mandibular fractures.
What are the technical characteristics of the 38.465.15 fixation?
The OBWEGESER mandibular fixation (reference 38.465.15) is characterized by its malleable structure, offering essential flexibility in maxillofacial surgery. Manufactured by Helmut Zepf Medizintechnik GmbH in Germany, it uses medical grade stainless steel. This device is delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before each use. Its design allows for multiple reprocessing, although no maximum limit of cycles is defined, as the lifespan depends on the absence of visible damage such as cracks or defects on the edges.
What are the contraindications for the use of this instrument?
The main medical contraindication lies in hypersensitivity or intolerance to metals. Contact with medical stainless steel can trigger an allergic reaction in certain patients. If such a hypersensitivity reaction occurs during the intervention, the manufacturer Helmut Zepf specifies that the procedure must be stopped immediately and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use the instrument if it shows visible signs of wear, such as breaks, cracks, or structural deformations compromising its safety.
What are the maintenance and reprocessing precautions?
Like any reusable Class I instrument, the obwegeser mandibular fixation must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to inspect the product for any visible damage (cracks, cutting defects) before intervention. Due to the materials used and the design of the instrument, the manufacturer does not establish a fixed limit for treatment cycles, but the user must verify compatibility with other products and ensure the functional condition of the malleable fixation before any surgical act.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This mandibular fixation equipment belongs to Class I according to medical device regulations. The manufacturer imposes strict cleaning and sterilization protocols in accordance with health safety standards. Helmut Zepf products are recognized for their precision in the field of maxillofacial surgery. The use of this instrument is strictly reserved for trained healthcare professionals, ensuring an application compliant with clinical data and manufacturer warnings.
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Specifications
| Manufacturer | Helmut Zepf |
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