Base Plate - Helmut Zepf (47.955.10) - Delynov
The Plateau de base - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.955.10.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf base tray (47.955.10)?
The Helmut Zepf base tray, referenced under code 47.955.10, is a device in the CONSO category designed for the organization of instrumentation in clinical environments. Manufactured from high-quality medical stainless steel, this stainless steel surgical tray constitutes a solid base for the handling and processing of manual instruments. This product is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH and requires a full preparation cycle before its first use in the office or operating room.
What are the clinical indications?
This device is indicated as a support for manual dental instrumentation during various oral surgery interventions. Its use is intended to facilitate the grouping of instruments required for implantology, periodontology, or extractive surgery procedures. As a stainless steel surgery tray, it participates in the organization of the operative field and the post-operative reprocessing process. Its use is strictly reserved for qualified healthcare professionals mastering asepsis and sterilization protocols.
What are the technical characteristics?
The Helmut Zepf base tray (reference 47.955.10) is designed in medical stainless steel, a material selected for its resistance to repeated cleaning and sterilization cycles. This stainless steel surgical tray does not have a defined maximum limit of processing cycles, as this depends on the maintenance and wear observed by the practitioner. It is essential to check for the absence of visible damage, such as cracks or breaks, before each use. This device belongs to Class I according to medical device regulations.
What are the contraindications for use?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns the patient's known hypersensitivity to metals. Contact with the medical stainless steel instrument can trigger an allergic reaction or intolerance in sensitive subjects. If such a hypersensitivity reaction occurs during the procedure, it must be immediately interrupted and necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before any intervention using this tray.
What are the maintenance and sterilization precautions?
All instruments, including this instrumentation box, must imperatively be cleaned, disinfected, and sterilized before the first use, and then after each subsequent use. The manufacturer emphasizes the crucial importance of cleaning each product before proceeding to sterilization. It is prohibited to use a product showing visible damage or wear, such as defects on edges or structural cracks. Compatibility with other products used in the instrumentation cassette must also be verified beforehand by the professional.
Who is the manufacturer and what standards are respected?
The base tray is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I (Class Ir according to certain reprocessing nomenclatures). The manufacturer guarantees that the product is designed to meet the requirements for manual dental instruments. Compliance with cleaning and sterilization protocols is the responsibility of the healthcare professional, in accordance with the instructions provided by Helmut Zepf to ensure patient safety and the longevity of the equipment.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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