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: 85.312.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf identification plate?
The Helmut Zepf identification plate, referenced under code 85.312.00, is an instrument management accessory designed for demanding clinical environments. Manufactured by Helmut Zepf Medizintechnik GmbH, it is made of medical stainless steel, ensuring compatibility with thermal reprocessing cycles. This device acts like an identification ring allowing for the segmentation and prioritization of manual instruments within cassettes or on surgical trays. Its role is purely organizational, aimed at improving workflow efficiency in the dental office or operating theater.
What are the clinical indications?
This device is indicated for dental tray organization during all oral surgery, periodontology, or implantology procedures. As a manual support dental instrument, it allows healthcare personnel to quickly differentiate instruments by color codes or by intervention sectors. Its use is particularly relevant during complex surgeries requiring a large number of tools, where the visual clarity of the tray is crucial for the fluidity of the surgical gesture. It helps maintain standardization of protocols within the clinical team.
What are the technical characteristics?
The Helmut Zepf plate (ref. 85.312.00) is a Class I device according to current regulations. It is delivered non-sterile and must imperatively undergo a full cycle of cleaning, disinfection, and sterilization before its first use and after each subsequent use. Its medical stainless steel design provides resistance to standard cleaning agents. Due to its metallic nature, compatibility with other products during reprocessing must be verified beforehand. No maximum limit for processing cycles is defined by the manufacturer, as this depends on visible wear and the integrity of the material.
What are the contraindications for use?
The main medical contraindication concerns intolerance or hypersensitivity to metals. If a patient presents a known or suspected allergic reaction upon contact with the medical stainless steel instrument, its use must be prohibited. In the event of a hypersensitivity reaction triggered during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH specifies that the intervention must be stopped immediately and necessary medical measures must be taken. It is therefore essential to evaluate the patient's history regarding metal allergies before any intervention involving this equipment.
What are the maintenance and safety precautions?
Before each use, the instrument must be inspected to detect any visible damage such as cracks, breaks, or surface defects. It is strictly forbidden to use damaged or worn products. The reprocessing process must be complete: cleaning, disinfection, and sterilization. Since the device is delivered non-sterile, this step is critical for patient safety. The manufacturer emphasizes that it is very important to clean each product before use to ensure the elimination of any residue. This equipment is exclusively reserved for qualified healthcare professionals mastering sterilization protocols.
Who is the manufacturer and what standards are met?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This product is classified as a Class I medical device (Class Ir according to certain reprocessing nomenclatures). It complies with manufacturing requirements for manual stainless steel dental instruments. Traceability is ensured by technical reference 85.312.00. As a Helmut Zepf product, it benefits from the brand's expertise in designing durable surgical tools, although the user must always refer to the manufacturer's specific instructions for cleaning and sterilization to maintain regulatory compliance.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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