Mandibular retractor - Helmut Zepf (38.467.10) - Delynov
The Écarteur mandibulaire - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 38.467.10.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf mandibular retractor (38.467.10)?
The mandibular retractor referenced 38.467.10 is a manual dental instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This device is manufactured from medical grade stainless steel, a material chosen for its resistance and compatibility with reprocessing processes in a surgical environment. As an instrument in the INSTRU category, it is specifically structured to help the practitioner retract soft tissues and cheeks, thereby offering increased visibility of the mandibular surgical site. This model is part of the range of precision instruments intended for oral surgery, guaranteeing reliable handling during critical phases of the intervention.
What are the clinical indications for this instrument?
The Helmut Zepf mandibular retractor is primarily indicated for tissue retraction during surgical interventions in the lower jaw. Its use is common in implantology to clear the surgical field before drilling or implant placement, as well as in periodontal surgery for maintaining muco-periosteal flaps. It is also used during extractions of impacted wisdom teeth or for any procedure requiring clear exposure of mandibular bone structures. This instrument helps protect surrounding soft tissues against accidental contact with rotating instruments, while stabilizing access for the dental surgeon.
What are the technical characteristics of the 38.467.10 retractor?
This instrument, bearing technical reference 38.467.10, is a Class I device according to medical device regulations. It is designed by Helmut Zepf Medizintechnik GmbH in medical stainless steel, guaranteeing durability against repeated cycles of cleaning and sterilization. Its ergonomic design allows for a stable grip for precise retraction without excessive fatigue for the assistant or practitioner. Due to its metallic composition and robustness, the manufacturer specifies that there is no defined maximum limit for processing cycles, as long as the instrument does not show visible damage such as cracks or defects on the edges.
What are the contraindications for the use of this retractor?
The main contraindication related to the use of this mandibular retractor is known hypersensitivity or intolerance of the patient to metals, specifically to medical stainless steel. A hypersensitivity reaction can be triggered upon contact between the instrument and the patient's tissues. The manufacturer Helmut Zepf specifies that if such a reaction occurs, the procedure must be immediately stopped and necessary medical measures must be taken. Before any intervention, it is therefore recommended to check the patient's allergic history regarding metallic components used in standard surgical instrumentation.
What are the maintenance and sterilization precautions?
Like any Helmut Zepf surgical instrument, this retractor is delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before its first use, as well as after each subsequent use. It is crucial to perform a meticulous visual inspection before each intervention to detect possible damage, breaks, or wear. The use of damaged products or those with defects on the cutting edges is strictly prohibited. The reprocessing process must follow standard hospital sterilization protocols for stainless steel. The longevity of the device depends on strict compliance with these cleaning instructions and verification of compatibility with other products used simultaneously.
Who is the manufacturer and what standards are respected?
The mandibular retractor is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I (Class Ir according to certain reprocessing nomenclatures). The manufacturer complies with current regulatory requirements for manual dental instruments. Use of this device is strictly reserved for qualified healthcare professionals. Helmut Zepf emphasizes the importance of following the instructions for use and safety provided to guarantee the performance of the instrument and patient safety throughout its life cycle, which is determined by the physical state of the object rather than a predefined number of cycles.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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