Curved Downward Spreader - Helmut Zepf (38.438.05) - Delynov
The Écarteur courbe vers le bas - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 38.438.05.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf curved downwards retractor?
The curved downwards retractor from the Helmut Zepf brand (reference 38.438.05) is a high-precision manual dental instrument. Manufactured from medical stainless steel, this device is specifically designed for tissue retraction during surgical interventions in the dental office. Its robust structure and meticulous finish guarantee reliable handling for practitioners. It belongs to the Class I instrument category, meeting regulatory requirements for non-invasive or short-term invasive devices. This tool is delivered non-sterile and requires a complete processing protocol before its first use in the mouth.
What are the clinical indications for this instrument?
This retractor is indicated for any oral surgery procedure requiring precise flap management. It is particularly used in implantology, periodontology, and during complex extractions to keep soft tissues away from the surgical site. Its downward curved design allows the dental surgeon to effectively clear the visual field while minimizing instrumental bulk. It serves as a stable support to secure incision areas and facilitate access to the bone or dental structures involved in the surgical act. Its use is strictly reserved for qualified healthcare professionals.
What are the technical characteristics of the 38.438.05 retractor?
The Helmut Zepf instrument is distinguished by its medical stainless steel composition, a standard material for durability and corrosion resistance. Its main feature lies in its downward curved orientation, identified under technical reference 38.438.05. Due to its design and the materials used, the manufacturer Helmut Zepf Medizintechnik GmbH specifies that there is no defined maximum limit for the number of processing cycles, as long as the instrument does not show visible damage. It is imperative to check for the absence of cracks, breaks, or defects on the edges before each intervention to guarantee patient safety.
What are the contraindications for using this retractor?
The main medical contraindication mentioned by the manufacturer concerns the patient's known hypersensitivity to metals. Contact between the medical stainless steel instrument and a patient with an intolerance may trigger an allergic reaction. If such a hypersensitivity reaction occurs during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the intervention must be stopped immediately and necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before any use of this manual instrument.
What are the maintenance and sterilization precautions?
Like any Helmut Zepf surgical instrument, this retractor must imperatively be cleaned, disinfected, and sterilized before the very first use, as well as after each subsequent use. Cleaning must be thorough to eliminate all biological residues. It is crucial to visually inspect the product to detect any wear or damage, such as cracks or defects on the edges. The use of a damaged or worn product is strictly prohibited. The reprocessing process must follow standard hospital or dental office sterilization protocols to ensure total asepsis of the device before its introduction into a sterile environment.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I medical device compliant with current regulations for manual dental instruments. The manufacturer ensures the traceability and quality of the medical stainless steel used. In accordance with MDR directives, the instrument is intended exclusively for healthcare professionals. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to guarantee the longevity of the product and the safety of the care provided to patients.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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