Osteotomy Kit Helmut Zepf for Dental Surgery (47.961.00) - Delynov
The Kit d'ostéotomie Helmut Zepf pour is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.961.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf Osteotomy Kit (47.961.00)?
The Helmut Zepf Osteotomy Kit, referenced under code 47.961.00, is a set of manual instruments specifically developed for bone surgery. This osteotomy set is manufactured from medical-grade stainless steel, ensuring resistance adapted to the constraints of surgical interventions. As a Class I medical device, it is designed by Helmut Zepf Medizintechnik GmbH to meet the requirements of practitioners in implantology and oral surgery. This equipment is delivered non-sterile and requires a complete preparation protocol before any clinical use.
What are the clinical indications for this kit?
This osteotomy set is indicated for all manual dental surgery procedures requiring intervention on bone tissue. It is primarily used during osteotomy phases to prepare the implant site or to perform structural corrections. Its use is strictly reserved for qualified healthcare professionals. The instruments in the kit allow for precise cutting and bone manipulation gestures, thus facilitating oral and periodontal surgery protocols where manual instrumentation is recommended by the manufacturer Helmut Zepf.
What are the technical characteristics of this instrument set?
The Helmut Zepf osteotomy kit is characterized by the use of high-quality medical stainless steel. Each manual instrument included in this kit is designed to withstand repeated cycles of cleaning, disinfection, and sterilization. The manufacturer specifies that due to the robust design and materials used, there is no defined maximum limit for the number of processing cycles, as long as the physical integrity of the instrument is preserved. It is imperative to check for the absence of visible damage, such as cracks or defects on the cutting edges, before each intervention.
What are the contraindications for the use of these instruments?
The main contraindication related to the use of this kit concerns known patient hypersensitivity to metals. Contact with medical stainless steel can trigger an allergic reaction or intolerance in certain individuals. If such a hypersensitivity reaction occurs during the procedure, the manufacturer Helmut Zepf stipulates that the intervention must be stopped immediately and necessary medical measures must be taken. Additionally, the use of instruments showing signs of wear, breakage, or defects on the sharp edges is formally prohibited to ensure patient safety.
What are the maintenance and sterilization precautions?
The instruments in this osteotomy kit are delivered non-sterile. According to the safety instructions from Helmut Zepf Medizintechnik GmbH, all products must imperatively be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. Reprocessing must be complete and rigorous. The practitioner must inspect each instrument to detect any trace of wear or corrosion. The use of damaged products is prohibited. Compatibility with other devices used during the intervention must also be verified beforehand to ensure the smooth progress of the surgery.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This instrument kit is classified as a Class I medical device according to current regulations. The manufacturer ensures the traceability and compliance of its stainless steel instruments intended for manual dental surgery. Compliance with the cleaning and sterilization protocols recommended by Helmut Zepf is essential to maintain device compliance and guarantee the safety of care during each osteotomy act.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
| Manufacturer | Helmut Zepf |
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