Elevator of sinus with 1 button - Helmut Zepf (47.847.11) - Delynov
The Élévateur de sinus à 1 bouton - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.847.11.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the 1-button sinus elevator - Helmut Zepf (47.847.11)?
The 1-button sinus elevator, referenced under code 47.847.11 by the manufacturer Helmut Zepf Medizintechnik GmbH, is a manual instrument specifically designed for oral surgery. This sinus lift instrument is manufactured from medical stainless steel, a standard material ensuring the rigidity necessary for pre-implant surgery interventions. As a Class I device, it meets the regulatory requirements for non-invasive or reusable instruments after processing. Its structure is designed to allow precise manipulation during the critical phases of membrane detachment, thus offering the practitioner a tool adapted to the anatomical constraints of the sinus area.
What are the clinical indications for this instrument?
This sinus elevator is indicated for oral surgery procedures aimed at increasing bone volume in the posterior region of the maxilla. Its primary use concerns the sinus lift (or sinus elevation), where it serves to detach and lift the Schneiderian membrane from the internal bony wall. This step is essential before the placement of filling materials or bone grafts. The use of this dental sinus elevator is strictly reserved for qualified healthcare professionals, such as dental surgeons, stomatologists, or implantologists, trained in advanced surgical techniques of the upper maxilla.
What are the technical characteristics of instrument 47.847.11?
The Helmut Zepf elevator (47.847.11) is distinguished by its monoblock design in medical stainless steel. It is a manual instrument delivered non-sterile, requiring a full reprocessing cycle before each use. Its 1-button configuration is specifically adapted to the ergonomics required for sinus access. The manufacturer Helmut Zepf specifies that, given the design and materials, there is no defined maximum limit for processing cycles (cleaning, disinfection, and sterilization), provided the instrument shows no visible damage. Compatibility with other surgical devices must be verified by the practitioner before any intervention.
What are the contraindications for the use of this elevator?
The main medical contraindication documented by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. Since the instrument is manufactured from medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the intervention, the procedure must be stopped immediately and the necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before using this instrument during a sinus lift.
What are the maintenance and reprocessing precautions?
Like any reusable surgical instrument, this elevator must undergo a strict cleaning, disinfection, and sterilization protocol before the first use and after each subsequent use. It is imperative to visually check the condition of the instrument to detect any cracks, breaks, or defects on the active parts. Helmut Zepf emphasizes that a damaged or worn product must never be used. The products are delivered non-sterile and must be processed in accordance with current hospital hygiene standards. Due to its stainless steel composition, compliance with sterilization parameters is crucial to maintain the integrity of the device over the long term.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Germany. The product is classified as a Class I medical device according to current regulations. It complies with the safety and performance requirements for manual dental instruments. The manufacturer ensures the traceability and quality of the materials used, particularly the medical stainless steel selected for its biocompatibility and resistance to repeated sterilization cycles. The use of this instrument is strictly reserved for healthcare professionals, guaranteeing an application consistent with established scientific data in implant surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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