Osteotomy Saw - Helmut Zepf (47.961.28) - Delynov
The Insert 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: 47.961.28.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf osteotomy insert?
The Helmut Zepf osteotomy insert, reference 47.961.28, is a specialized manual instrument used in oral surgery. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is designed in high-quality medical stainless steel to ensure structural resistance during bone manipulation. As a Class I instrument, it meets regulatory requirements for non-invasive or invasive devices for temporary use. Its design allows practitioners to perform precise technical movements during bone cutting phases, which are essential in many reconstruction or implant preparation protocols.
What are the clinical indications for this insert?
This osteotomy insert is primarily indicated for oral surgery interventions requiring direct action on bone tissue. It is used by dental surgeons and implantologists to perform osteotomies, root separations, or alveolar ridge rectifications. Its role is central in preparing recipient sites before implant placement or during corrective surgeries. As a manual instrument, it offers increased tactile sensitivity, allowing control of the force applied to the cutting edges when working on cortical or cancellous structures.
What are the technical characteristics of this instrument?
The Helmut Zepf insert (reference 47.961.28) is characterized by its manufacture in medical stainless steel, a standard material for surgical instrumentation ensuring durability through sterilization cycles. It is a manual instrument delivered non-sterile, requiring a complete cleaning, disinfection, and sterilization protocol before the first use and between each patient. The manufacturer specifies that due to its robust design and the materials used, there is no defined maximum limit for processing cycles, although visual inspection of the wear on the cutting edges is imperative before each use.
What are the contraindications for the use of this insert?
The main medical contraindication documented by Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity or intolerance to metals, particularly medical stainless steel. If an allergic reaction or hypersensitivity reaction is triggered in the patient upon contact with the instrument, the surgical procedure must be immediately interrupted. Necessary corrective measures must then be applied. It is therefore recommended to check the patient's allergic history before any intervention involving this Class I instrument.
What are the maintenance and safety precautions?
Like any Helmut Zepf brand surgical instrument, this insert must undergo rigorous reprocessing. Before each use, the practitioner must visually inspect the product to detect potential damage such as cracks, breaks, or defects on the cutting edges. The use of damaged or worn products is strictly prohibited to ensure patient safety. Additionally, compatibility with other devices used during the intervention must be verified beforehand. The sterilization process must follow standard protocols applicable to medical stainless steel instruments.
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. This medical device belongs to Class I according to current regulations. The manufacturer emphasizes that the use of this osteotomy insert is strictly reserved for qualified healthcare professionals. Compliance with cleaning, disinfection, and sterilization protocols is the responsibility of the practitioner, in accordance with the instructions provided by Helmut Zepf to maintain the integrity of the medical stainless steel and ensure clinical safety.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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