Instrument Stand - Helmut Zepf (85.181.09) - Delynov
The Support pour instruments - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 85.181.09.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf instrument support (85.181.09)?
The Helmut Zepf instrument support, referenced under code 85.181.09, is a storage device designed by Helmut Zepf Medizintechnik GmbH. This product is manufactured from medical stainless steel, a standard material for surgical instrumentation ensuring compatibility with decontamination processes. This dental instrument rack is specifically developed to organize manual instruments, thus facilitating quick and orderly access to the tools required during clinical procedures. It is part of an approach to optimize the workspace in dental and implant surgery. As an instrument storage support, it keeps devices in a secure position before, during, or after their use.
What are the clinical indications for this device?
This device is indicated as an accessory for manual dental instrumentation. Its primary use concerns the organization of technical trays during oral surgery, periodontology, or implantology procedures. Although the regulatory text simply defines it as a manual dental instrument, its function as a sterilization instrument support is central to maintaining therapeutic order. It helps prevent damage to the active parts of instruments, such as cutting edges, by avoiding direct impacts between tools. Its use is reserved exclusively for qualified healthcare professionals, in accordance with the directives of the manufacturer Helmut Zepf.
What are the technical characteristics of this support?
The Helmut Zepf support (85.181.09) is designed in high-quality medical stainless steel. It is delivered non-sterile and requires a full reprocessing cycle before its first use and after each subsequent use. Technical characteristics include resistance to disinfection agents and the high temperatures of steam sterilization cycles. The manufacturer specifies that due to its design and the materials used, there is no defined maximum limit for the number of achievable treatment cycles, subject to a prior visual inspection. The user must imperatively check for the absence of cracks, breaks, or visible defects before each intervention.
What are the contraindications for the use of this equipment?
The main contraindication mentioned by Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals in the patient. Since the instrument is composed of medical stainless steel, direct contact can trigger an allergic reaction in sensitive subjects. If such a hypersensitivity reaction occurs during the care act, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's anamnesis regarding metal allergies before any manipulation near gingival or bone tissues.
What are the maintenance and sterilization precautions?
All Helmut Zepf products must be cleaned, disinfected, and sterilized before their first commissioning. The reprocessing process must be complete. It is imperative to clean each product before looking for visible damage such as cracks or wear on the cutting edges. The use of damaged or worn products is strictly prohibited. Compatibility with other cleaning products or other instruments must also be verified beforehand. As it is a non-resorbable and reusable device, maintaining its structural integrity depends on rigorous compliance with the sterilization protocols in force in the dental practice.
Who is the manufacturer and what standards are respected?
The official manufacturer is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This instrument support is classified as a Class I medical device (Class Ir according to the MDC0483 marking mentioned in the source data). Compliance with manufacturing standards ensures that the device meets safety requirements for professional use in a surgical environment. As a recognized manufacturer, Helmut Zepf ensures the traceability of its products via precise references, such as code 85.181.09, allowing practitioners to equip themselves with material compliant with European dental instrumentation standards.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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