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: 85.312.08.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf identification plate?
The identification plate - Helmut Zepf (85.312.08) is a consumable category accessory designed for the organization of manual instrumentation in dental practices. Manufactured by Helmut Zepf Medizintechnik GmbH, this plate is made of medical stainless steel, ensuring compatibility with cleaning and sterilization cycles. It primarily serves as a marking support to establish an effective instrument color code, allowing practitioners and assistants to quickly differentiate surgical sets or types of instruments during pre- and post-operative phases.
What are the clinical indications?
This device is indicated as an accessory for manual dental instrumentation used in oral, periodontal, or implant surgery. Its role is strictly organizational: it allows for the identification of instruments belonging to specific kits. Although the plate itself does not perform a surgical act, it accompanies the instruments that come into contact with tissues during interventions. Its use is reserved for trained healthcare professionals, ensuring a smooth workflow in the operating block or treatment room.
What are the technical characteristics?
The plate bears the technical reference 85.312.08. It is manufactured from medical stainless steel, a material chosen for its resistance to thermal and chemical reprocessing cycles. According to data from the manufacturer Helmut Zepf, the product is delivered non-sterile and must undergo a full cycle of cleaning, disinfection, and sterilization before its first use, as well as between each patient. Due to its robust design and the materials used, there is no defined maximum limit for processing cycles, subject to a visual inspection for the absence of damage.
What are the contraindications for use?
The main medical contraindication concerns patients with hypersensitivity or intolerance to metals, specifically medical stainless steel. If a hypersensitivity reaction is triggered during indirect or direct contact with the instrumentation associated with the plate, the procedure must be immediately stopped and necessary clinical measures must be taken. It is the practitioner's responsibility to check the patient's allergic history before any intervention involving this type of metallic equipment.
What are the maintenance and reprocessing precautions?
All Helmut Zepf products must be cleaned, disinfected, and sterilized before each use. Before processing, the practitioner must visually inspect the plate for any damage such as cracks, breaks, or surface defects. The use of damaged or worn products is prohibited. Compatibility with other products in the instrumentation set must also be verified beforehand. The reprocessing process must follow standard hospital or practice sterilization protocols to ensure total asepsis of the technical tray.
Who is the manufacturer and what standards are met?
The official manufacturer is Helmut Zepf Medizintechnik GmbH, located in Germany. This medical device belongs to Class I (Class Ir according to MDR mentions). The manufacturer ensures that the instruments are designed to meet safety and performance requirements in surgical environments. Traceability is ensured by reference 85.312.08. As a Class I device, it complies with the European regulatory frameworks in force for reusable manual dental instruments, requiring rigorous maintenance by qualified healthcare professionals.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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