Osteotomy Set - Helmut Zepf (47.962.20) - Delynov
The Insert d'ostéotomie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.962.20.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf osteotomy insert (47.962.20)?
The osteotomy insert referenced under code 47.962.20 is a specialized manual instrument designed by Helmut Zepf Medizintechnik GmbH. Manufactured from high-quality medical stainless steel, this device is intended for bone surgery procedures within the oral cavity. It belongs to the category of reusable consumables (CONSO) and benefits from a robust design adapted to the requirements of dental operating theaters. As a manual instrument, it allows the practitioner to exercise direct control during the cutting or rectification phases of bone volumes, guaranteeing handling in accordance with the clinical standards of the Helmut Zepf brand.
What are the clinical indications for this instrument?
This instrument is indicated for any procedure requiring a manual osteotomy. In oral surgery and implantology, it is used for the preparation of implant sites, bone block harvesting, or the creation of windows during sinus lifts. Its use also extends to periodontal surgery for the regularization of alveolar ridges. According to the specifications of the manufacturer Helmut Zepf Medizintechnik GmbH, this manual dental instrument is strictly reserved for qualified healthcare professionals. It is used in remodeling phases where the precision of manual movement is preferred to respect the surrounding anatomical structures.
What are the technical characteristics of the 47.962.20 insert?
The Helmut Zepf osteotomy insert is characterized by its manufacture in medical stainless steel, a material chosen for its mechanical resistance and its compatibility with repeated sterilization processes. This device is classified as a Class I instrument according to current regulations. It is delivered non-sterile and requires a complete reprocessing protocol before each use. The design of the instrument does not define a maximum limit of use cycles, as this depends on maintenance and the appearance of any visible damage such as cracks or wear of the cutting edges, which must be systematically checked by the practitioner.
What are the contraindications for the use of this insert?
The main medical contraindication documented by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity or intolerance to metals. Contact of the medical stainless steel with the tissues of an allergic patient can trigger a hypersensitivity reaction. If such a reaction occurs during the intervention, the procedure must be immediately interrupted and the necessary corrective measures must be applied. It is therefore imperative to check the patient's allergic history before any use. Furthermore, the use of the instrument is prohibited if it shows visible defects, breakages, or marked wear of the active parts.
What are the maintenance and sterilization precautions?
Like any Helmut Zepf instrument delivered non-sterile, the osteotomy insert must imperatively undergo cleaning, disinfection, and sterilization before the first use, and then after each subsequent use. The practitioner must carefully inspect the instrument to detect any trace of corrosion, cracks, or dulling of the sharp edges. The use of damaged products is strictly prohibited to guarantee patient safety. Although no cycle limit is set, the longevity of the insert depends on rigorous compliance with reprocessing protocols and verification of compatibility with other devices used during the procedure.
Who is the manufacturer and what standards are respected?
This insert is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. The device is a Class I instrument, compliant with regulatory requirements for manual dental instruments. The manufacturer insists that these products are exclusively reserved for professional use by trained healthcare practitioners. Following safety instructions, including systematic cleaning and sterilization, is a sine qua non condition for maintaining the compliance and performance of the instrument during its clinical life cycle.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |