PLAQUETTE D'IDENTIFICATION - Helmut Zepf
The Plaquette d'identification - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 85.312.01.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf identification plate (85.312.01)?
The Helmut Zepf identification plate, referenced under code 85.312.01, is an instrumentation management accessory intended for dental surgery and implantology practices. This device, designed by Helmut Zepf Medizintechnik GmbH, comes in the form of a robust color pellet. Its primary role is to allow rapid visual differentiation of manual instruments within a technical tray. Manufactured to withstand the constraints of clinical environments, it helps structure workflows by enabling efficient and durable autoclave marking. This product belongs to the technical consumables category (CONSO) and meets the quality requirements of a recognized manufacturer in the precision medical instrumentation sector.
What are the clinical indications for this accessory?
Although the plate itself is not a cutting or insertion instrument, its clinical indication is part of the global framework of using manual dental instruments. It is used to organize instrument sets during oral surgery, periodontology, or implantology procedures. By facilitating visual identification, it reduces the risk of handling errors and optimizes preoperative preparation time. According to data from the manufacturer Helmut Zepf, the intended use concerns the organization of manual instrumentation. Its integration into the reprocessing cycle maintains consistent visual traceability, ensuring that each instrument is correctly assigned to its specific kit before any surgical intervention.
What are the technical characteristics of this marking device?
The Helmut Zepf identification plate (reference 85.312.01) is designed to withstand repeated cycles of cleaning, disinfection, and sterilization. As an autoclave marking solution, it retains its physical properties and visibility even after prolonged exposure to high temperatures and chemical decontamination agents. This device is classified as a Class I medical device, which confirms its compliance with basic regulatory requirements for non-invasive instrumentation accessories. Its simple design allows for secure attachment to the handles of manual instruments, preventing accidental detachment during clinical procedures or ultrasonic cleaning phases.
What are the contraindications for the use of this product?
The major contraindications mainly concern biological reactions related to materials. Although the plate is an external accessory, it is associated with instruments made of medical stainless steel. The manufacturer Helmut Zepf specifies that metal intolerance in a patient can lead to a hypersensitivity reaction during contact, even indirect, with the instrumentation. If such a reaction occurs, the clinical procedure must be immediately interrupted and necessary medical measures must be taken. It is therefore imperative to check the allergic history of patients before any intervention. Furthermore, the use of damaged, cracked, or visibly defective pellets is strictly prohibited to avoid any risk of contamination.
What are the precautions related to reprocessing and sterilization?
Helmut Zepf products are delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before the first use, and then between each patient. Due to the design of the plate and the materials used, there is no defined maximum limit for treatment cycles, but a rigorous visual inspection is mandatory before each use. The practitioner must actively look for signs of wear, such as cracks or breaks. Any accessory showing degradation must be discarded. Compatibility with other cleaning products and standard sterilization protocols must be verified beforehand to ensure the integrity of the color marking.
Who is the manufacturer and what standards are met?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany, recognized for its expertise in the production of high-precision dental instruments. This product is a Class I medical device, in accordance with current Medical Device Regulations (MDR). Compliance with these standards ensures that the identification plate meets the safety and performance requirements for professional use in a surgical environment. As a Class I device, it is subject to strict quality controls during its manufacture to ensure its thermal and chemical resistance, essential for an accessory intended for autoclave marking in dental practices.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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