Osteotomy Instrument - Helmut Zepf (47.943.20) - Delynov
The Instrument 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: 47.943.20.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf (47.943.20) osteotomy instrument?
The osteotomy instrument referenced under code 47.943.20 is a manual dental instrument developed by Helmut Zepf Medizintechnik GmbH. It belongs to the category of surgical instruments (INSTRU) and is manufactured from high-quality medical stainless steel. This device is designed to meet the requirements of dental surgeons during specific bone manipulations. As a manual instrument, it offers direct tactile feedback during clinical use. This product is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before each use to ensure the safety of the patient and the practitioner.
What are the clinical indications?
The official indication for this device is that of a manual dental instrument intended for oral surgery. In clinical practice, this osteotome is used for preparing recipient sites during implant placement or for other bone surgery interventions requiring controlled cutting or compression of the bone. It is particularly suitable for osteotomy procedures where the precision of manual instrumentation is required to preserve surrounding anatomical structures. Its use is strictly reserved for qualified healthcare professionals mastering oral and implant surgery techniques.
What are the technical characteristics of this instrument?
The Helmut Zepf osteotomy instrument is characterized by its medical stainless steel construction, a standard material for surgical instrumentation ensuring resistance to repeated sterilization cycles. Referenced under code 47.943.20, it is part of the Helmut Zepf Medizintechnik GmbH range. Its design allows for long-lasting use, although there is no defined maximum limit for processing cycles, provided the instrument shows no visible damage. Before each intervention, the practitioner must imperatively check for the absence of cracks, breaks, or defects on the cutting edges to maintain the device's operational efficiency.
What are the contraindications for use?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns known hypersensitivity to metals. As the instrument is composed of medical stainless steel, contact with the patient can trigger an intolerance reaction in sensitive subjects. If such a hypersensitivity reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken. It is therefore recommended to check the patient's allergic history before any use. Furthermore, the use of an instrument showing signs of wear, cracks, or defects on the sharp edges is formally prohibited.
What are the maintenance and reprocessing precautions?
All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use as well as after each subsequent use. The reprocessing process must be complete to ensure asepsis. The manufacturer emphasizes that it is crucial to check the condition of the instrument before each act: any visible damage such as cracks or breaks makes the instrument unfit for use. Due to the robust design and materials used, there is no fixed limit to the number of sterilization cycles, but the physical integrity of the instrument must remain the validation criterion for its use in the operating room.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The device is classified as a Class I instrument according to current regulations. It meets the strict manufacturing requirements for manual medical devices. The products are delivered non-sterile, placing responsibility on the healthcare professional for cleaning and prior sterilization according to current hospital or practice protocols. Traceability is ensured by the technical reference 47.943.20 specific to the brand's catalog.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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