Sinus Lift Instrument Figure 1 - Helmut Zepf (41.847.08) - Delynov
The Instrument de Sinus-Lift Figure 1 - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.847.08.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Sinus-Lift Instrument Figure 1?
The Sinus-Lift Instrument Figure 1, bearing reference 41.847.08, is a manual device developed by the manufacturer Helmut Zepf Medizintechnik GmbH. Specifically designed for dental sinus surgery, this tool is manufactured from high-quality medical stainless steel to ensure optimal resistance during interventions. It belongs to the category of manual instruments (INSTRU) and is an essential element for practitioners specializing in implantology and oral surgery performing sinus elevations.
What are the clinical indications?
This instrument is indicated for sinus surgery interventions, particularly during sinus-lift procedures (sinus elevation) via lateral or crestal approaches. Its primary role is to assist the dental surgeon or implantologist in the manipulation and detachment of the sinus membrane. As a manual dental instrument, it is used to prepare the sinus floor before the insertion of bone grafting materials or the placement of implants, thus ensuring a controlled approach to the sensitive anatomical structures of the maxilla.
What are the technical characteristics?
The Helmut Zepf instrument (ref. 41.847.08) is a Class I device according to the regulatory classification of medical devices. It is entirely composed of medical stainless steel, a material chosen for its biocompatibility and its ability to undergo repeated cleaning and sterilization cycles. The product is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, which requires a strict preparation protocol before its first use in the office or operating room.
What are the contraindications for use?
The main medical contraindication mentioned by the manufacturer concerns hypersensitivity or intolerance to metals. If a patient presents a known allergic reaction or triggers a hypersensitivity reaction upon contact with the medical stainless steel during the intervention, the procedure must be stopped immediately. Appropriate corrective measures must then be taken. It is therefore crucial to evaluate the patient's allergic history before any use of this sinus surgery instrument.
What are the maintenance and reprocessing precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The practitioner must visually inspect the device to detect any damage or wear, such as cracks, breaks, or defects on the active parts. Due to the design and materials used, there is no defined maximum limit for treatment cycles, but the use of damaged or worn products is strictly prohibited to guarantee clinical safety.
Who is the manufacturer and what standards are respected?
The official manufacturer is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This device is classified as Class I in accordance with European medical device regulations. The manufacturer emphasizes that the use of this instrument is strictly reserved for qualified healthcare professionals. Compliance with cleaning and sterilization protocols, as well as verification of compatibility with other products used during surgery, are the responsibility of the practitioner.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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