Elevator X - LUXA - TOOL - 1 - Helmut Zepf (17.007.01) - Delynov
The Elévateur X - LUXA - TOOL - 1 - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 17.007.01.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the X LUXA TOOL 1 elevator?
The X LUXA TOOL 1 elevator, referenced under code 17.007.01 at Delynov, is a precision manual instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed in high-quality medical stainless steel, this tool is specifically structured for dental extraction procedures. Its material composition ensures the necessary resistance to the leverage forces applied during luxation. As a Class I device, it meets the safety requirements for non-invasive or reusable surgical instruments after processing. Its straight design and sharpened tip allow for precise insertion into the periodontal space to facilitate the release of the dental structure.
What are the clinical indications?
This instrument is indicated for oral surgery and general practice during avulsion phases. Its intended purpose is to serve as a manual instrument for lifting teeth or residual dental roots during the act of extraction. It is particularly useful for fractured roots or firmly anchored teeth where prior luxation is required to minimize alveolar trauma. The use of this Helmut Zepf elevator allows the tooth to be mobilized by breaking the ligament fibers, thus preparing the way for forceps. It is intended exclusively for healthcare professionals trained in surgical extraction techniques.
What are the technical characteristics of this instrument?
The X LUXA TOOL 1 elevator (reference 17.007.01) is distinguished by its straight configuration, optimized for direct access to surgical sites. Manufactured by Helmut Zepf, it is made of medical stainless steel, a material chosen for its mechanical properties and its ability to withstand repeated cleaning and sterilization cycles. Although the manufacturer does not define a strict maximum limit for processing cycles due to the robustness of the materials, the instrument must be inspected before each use. Practitioners must check for the absence of visible damage, such as cracks, breaks, or defects on the cutting edges, to guarantee the effectiveness of the surgical procedure.
What are the contraindications for use?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity of the patient to metals. Since the instrument is made of medical stainless steel, contact can trigger an intolerance or hypersensitivity reaction in certain individuals. If such a reaction occurs during the intervention, the procedure must be immediately interrupted and the necessary medical measures must be taken. It is therefore imperative to validate the patient's history regarding metal allergies before any manipulation. Apart from this specific sensitivity, use is restricted to qualified healthcare professionals.
What are the maintenance and reprocessing precautions?
Helmut Zepf products are delivered non-sterile and require a strict protocol before any use. All instruments must be cleaned, disinfected, and sterilized before the first use, and then after each subsequent use. Complete cleaning is crucial to remove any biological residue before sterilization. It is imperative never to use damaged or worn products showing visible signs of wear on the cutting edges. The longevity of the elevator depends on compliance with these safety and maintenance instructions. Reprocessing must be carried out according to the hospital standards in force for reusable Class I devices.
Who is the manufacturer and what standards are respected?
The X LUXA TOOL 1 elevator is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to the regulations in force. The manufacturer ensures the compliance of its instruments with safety and performance requirements for use in a dental surgical environment. Each product, such as model 17.007.01, is subject to rigorous quality controls to guarantee its reliability during extraction procedures. As a reusable device, it is designed to withstand standard hospital decontamination protocols, subject to systematic inspection by the practitioner.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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