Spacer Obwegeser OUT - Helmut Zepf (38.428.06) - Delynov

What is the Obwegeser OUT Helmut Zepf retractor?

The Obwegeser OUT retractor, referenced under code 38.428.06, is a high-precision surgical instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed in high-quality medical stainless steel, this tool belongs to the category of reusable consumables (CONSO) for oral and maxillofacial surgery. Its structure is specifically studied to offer optimal mechanical resistance while ensuring safe handling during tissue retraction. As a Class I device, it meets the safety requirements for non-invasive or transiently invasive instruments. Its manufacture by Helmut Zepf ensures compliance with the rigorous standards of German surgical instrumentation.

What are the clinical indications for this instrument?

The primary indication for this instrument, as defined by the manufacturer Helmut Zepf, is to maintain the surgical area open. In clinical practice, the Obwegeser OUT retractor is used by dental surgeons and oral surgery specialists to retract soft tissues, cheeks, or mucoperiosteal flaps. Its use is particularly relevant during orthognathic surgeries, bone harvesting, or complex implant placements where surgical site visibility is crucial. It allows for stabilizing access to deep anatomical structures while protecting surrounding tissues from rotating or sharp instruments used during the operative act.

What are the technical characteristics of the 38.428.06 retractor?

The Obwegeser OUT retractor (reference 38.428.06) is distinguished by its medical stainless steel composition, a material chosen for its biocompatibility and corrosion resistance. This instrument is delivered non-sterile by Helmut Zepf Medizintechnik GmbH and requires a full preparation cycle before each use. Although it is a robust device, the manufacturer specifies that due to the product design and materials used, there is no defined maximum limit for the number of processing cycles, provided the integrity of the instrument is preserved. It is imperative to check for the absence of visible damage, such as cracks, breaks, or defects on the edges before any intervention.

What are the contraindications for the use of this retractor?

The main medical contraindication mentioned by the manufacturer concerns known hypersensitivity to metals. As the instrument is manufactured from medical stainless steel, contact with the patient may trigger an allergic reaction or intolerance in sensitive individuals. If a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore recommended to validate the absence of allergies to metallic components during the preoperative anamnesis. Furthermore, the use of the instrument is strictly reserved for qualified healthcare professionals mastering the associated surgical techniques.

What are the maintenance and sterilization precautions?

The Obwegeser OUT retractor is a reusable instrument that requires a strict reprocessing protocol. According to Helmut Zepf safety instructions, all instruments must be cleaned, disinfected, and sterilized before the first use, as well as before each subsequent use. Cleaning is a critical step that must be performed with care to eliminate all biological residue. Before sterilization, the practitioner must inspect the instrument to detect any visible wear or structural damage. It is strictly forbidden to use damaged or worn products. Compatibility with other products used during the sterilization chain or the surgical act must also be verified beforehand.

Who is the manufacturer and what standards are respected?

This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. The manufacturer is recognized for its expertise in the production of high-tech medical devices. The Obwegeser OUT retractor is classified as a Class I medical device according to current regulations. Compliance with manufacturing protocols guarantees a reliable instrument for operating rooms. Helmut Zepf products are delivered non-sterile, leaving the responsibility for the final sterilization cycle to the healthcare professional. Following the manufacturer's instructions regarding cleaning and maintenance is essential to ensure patient safety and the longevity of the stainless steel instrument.

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Surgical medical consumables play a decisive role in operative safety.