Root Elevator - Helmut Zepf (17.396.02) by Lindo-Levien
The Lindo-Levien Élévateur à Racines - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 17.396.02.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf Lindo-Levien root elevator?
The Lindo-Levien root elevator, referenced under code 17.396.02, is a manual instrument designed by Helmut Zepf Medizintechnik GmbH. This device is manufactured from medical stainless steel, a standard material for surgical instrumentation ensuring resistance to sterilization processes. It belongs to the category of oral surgery instruments and is presented as a robust tool intended for the manipulation of root structures. As a Class I device, it meets the basic regulatory requirements for non-invasive or invasive instruments for temporary use.
What are the clinical indications for this instrument?
This instrument is indicated as a manual dental instrument for extraction procedures. More specifically, the Lindo-Levien elevator is used by dental surgeons and implantologists to facilitate the removal of dental roots. Its primary role is to intervene in the socket to break ligament attachments and luxate the root before its final removal. It is particularly suitable for clinical situations requiring an effective lever to mobilize root fragments or teeth for which forceps grip is complex or impossible.
What are the technical characteristics of the 17.396.02 elevator?
The Helmut Zepf 17.396.02 elevator is characterized by its high-quality medical stainless steel construction. This material is chosen for its ability to withstand repeated cycles of cleaning, disinfection, and sterilization. The instrument is delivered non-sterile, which necessitates a strict treatment protocol before the first use and between each patient. The Lindo-Levien design offers specific ergonomics for the transmission of forces during root luxation. Each product must be visually inspected before use to detect any potential cracks, breaks, or defects on the cutting edges.
What are the contraindications for the use of this device?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity to metals. An intolerance in the patient may result from contact with the medical stainless steel composing the instrument, potentially triggering an allergic reaction. If such a hypersensitivity reaction occurs during the surgical procedure, the procedure must be stopped immediately and the necessary medical measures must be taken. It is therefore crucial to check the patient's allergic history before any intervention with this type of metallic instrumentation.
What are the maintenance and reprocessing precautions?
Helmut Zepf Medizintechnik GmbH products are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before the first use as well as after each subsequent use. The manufacturer emphasizes the importance of cleaning each product before checking for visible damage such as cracks or edge wear. It is strictly forbidden to use a damaged instrument. Due to the design and materials used, there is no defined maximum limit of treatment cycles, as long as the instrument does not show signs of wear compromising its safety or effectiveness.
Who is the manufacturer and what standards are respected?
The official manufacturer of this elevator is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer mandates that the use of this instrument be strictly reserved for qualified healthcare professionals. Compliance with safety standards relies on rigorous adherence to the cleaning and sterilization instructions issued by Helmut Zepf, thus ensuring the safety of the patient and the practitioner during dental surgery interventions.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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