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: 85.312.09.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf (85.312.09) identification plate?
The Helmut Zepf identification plate, referenced under code 85.312.09, is an instrumental management accessory designed by Helmut Zepf Medizintechnik GmbH. This device, belonging to the consumables category (CONSO), is manufactured from medical stainless steel. It is specifically developed to be fixed onto manual instruments to facilitate visual recognition. As an instrument identification ring, it allows practitioners and assistants to structure surgical kits by type of intervention or by practitioner, thus ensuring rigorous workflow organization within the dental practice or oral surgery clinic.
What are the clinical indications for this device?
According to data from the manufacturer Helmut Zepf Medizintechnik GmbH, this device is indicated as an accessory for manual dental instruments. Its primary clinical application lies in the organization of instruments used during oral surgery, implantology, or periodontology procedures. Although the plate itself does not directly intervene in the operative act, it is inseparable from the management of reusable medical devices. It helps maintain the order of technical trays, thereby reducing instrument selection time during critical phases of the surgical intervention.
What are the technical characteristics of the 85.312.09 plate?
The Helmut Zepf 85.312.09 identification plate is a Class I device. It is designed in medical-grade stainless steel, a material chosen for its resistance to repeated processing cycles. This product is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH. It is imperative to perform complete cleaning, disinfection, and sterilization before the first use, as well as between each patient. Its robust design allows it to withstand the thermal and chemical stresses of standardized reprocessing protocols in a medical environment without immediate degradation of its structure or its function as an instrument identification ring.
What are the contraindications for the use of this product?
The main contraindication mentioned by the manufacturer concerns metal intolerance. A hypersensitivity reaction or intolerance in the patient may result from direct or indirect contact with the instrument, as it is composed of medical stainless steel. If such an allergic reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore recommended to check the patient's allergic history before any use of devices containing metal alloys.
What are the maintenance and reprocessing precautions?
All Helmut Zepf products must be cleaned, disinfected, and sterilized before their first use and after each subsequent use. Before any use, the practitioner must visually inspect the plate to detect any possible damage or visible wear, such as cracks, breaks, or structural defects. It is strictly forbidden to use damaged or worn products. Due to the product design and the materials used, there is no defined maximum limit for the number of processing cycles achievable, as long as the integrity of the device is preserved. Compatibility with the other instruments on which it is fixed must also be verified beforehand.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This product is classified as a Class I medical device according to current regulations. The manufacturer specifies that the use of these instruments is strictly reserved for qualified healthcare professionals. Compliance with cleaning and sterilization protocols is the responsibility of the end user to ensure patient safety and equipment longevity. Traceability is ensured by the technical reference 85.312.09 specific to the Helmut Zepf catalog.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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