Radicular canal spreader - Helmut Zepf (19.513.03) - Delynov
The Écarteur de canal radiculaire - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 19.513.03.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf root canal retractor?
The Helmut Zepf root canal retractor, bearing reference 19.513.03, is a specialized manual instrument for endodontics and root surgery. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is designed in high-quality medical stainless steel. Its structure is optimized to offer precise handling during the retraction of canal structures or adjacent soft tissues. As a root spreader, it helps the practitioner clear the field of vision and action necessary for complex interventions at the level of the dental root. It belongs to Class I of medical devices, guaranteeing its compliance with safety requirements for non-invasive or minimally invasive manual instruments.
What are the clinical indications for this canal retractor?
This root retractor is indicated for endodontic procedures, particularly during the preparation, exploration, or filling of canals. Its primary role is to serve as a dental spreader to facilitate access to narrow areas of the canal system. In endodontic surgery, it allows for tissue maintenance or the guidance of filling materials. The use of this Helmut Zepf instrument is strictly reserved for qualified healthcare professionals, such as dental surgeons and endodontists, operating within the framework of root treatments aimed at preserving the natural tooth or treating periapical infections.
What are the technical characteristics of reference 19.513.03?
The Helmut Zepf retractor (reference 19.513.03) is characterized by its medical stainless steel construction, a material chosen for its corrosion resistance and its ability to withstand repeated sterilization cycles. This instrument is delivered non-sterile and requires a complete cleaning and disinfection protocol before its first use, as well as between each patient. Its ergonomic design meets the precision needs of dental micro-surgery. The manufacturer specifies that due to the nature of the materials and design, there is no defined maximum limit for processing cycles, although the instrument must be visually inspected for any signs of wear or damage before use.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. Since the instrument is composed of medical stainless steel, contact with the patient can trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the procedure, it must be immediately interrupted and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use the instrument if it shows visible damage such as cracks, breaks, or defects on the active parts, as this could compromise patient safety and the effectiveness of the care.
What are the maintenance and reprocessing precautions?
Like any Class I instrument intended for surgery, this canal retractor must follow a rigorous reprocessing protocol. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to check for the absence of damage and wear before each intervention. The use of damaged or worn products is prohibited. Since the device is delivered non-sterile, the responsibility for sterilization lies with the dental practice. The manufacturer also emphasizes that compatibility with other products used simultaneously must be verified beforehand to ensure the success of the clinical procedure.
Who is the manufacturer and what standards are respected?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I (Class Ir according to certain reprocessing nomenclatures). It complies with the regulatory requirements applicable to manual dental instruments. The manufacturer ensures the traceability and quality of the medical stainless steel used. As a Helmut Zepf product, this retractor benefits from German expertise in medical engineering, guaranteeing a reliable tool for dental surgeons. Professionals must refer to the manufacturer's instructions for cleaning and sterilization to maintain the compliance and safety of the device throughout its service life.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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