Universal Prophylaxis Kit Bionik - Helmut Zepf (24.990.60) - Delynov
The Kit de prophylaxie universel Bionik - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.990.60.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Bionik universal prophylaxis kit - Helmut Zepf?
The Bionik universal prophylaxis kit, referenced under code 24.990.60 by Helmut Zepf, is a set of manual instruments specifically designed for hygiene and preventive care. Manufactured by Helmut Zepf Medizintechnik GmbH, this prophylaxis set is composed of instruments made of high-quality medical stainless steel. It is intended for healthcare professionals to perform professional cleaning and periodontal maintenance procedures. As a Class I device, it meets the regulatory requirements for non-invasive or short-term invasive dental instruments, guaranteeing a robust structure suitable for the repeated cleaning and sterilization cycles required in the practice.
What are the clinical indications for this prophylaxis set?
This dental prophylaxis kit is indicated for all manual tartar and dental plaque removal procedures. Its primary use concerns clinical prophylaxis, including supra-gingival scaling and light root planing. The instruments are used to eliminate calcified deposits and extrinsic stains on dental surfaces. This scaling kit is also used in the preparation of the surgical field before oral or implant surgery, allowing for the sanitization of the oral environment. It is exclusively reserved for use by qualified healthcare professionals capable of handling these manual instruments with the precision required to preserve the integrity of soft tissues and enamel.
What are the technical characteristics of Helmut Zepf instruments?
The instruments included in this dental scaling kit are characterized by their manufacture in medical stainless steel, a material chosen for its corrosion resistance and durability. The manufacturer Helmut Zepf Medizintechnik GmbH specifies that, although no maximum limit for processing cycles is defined, the lifespan of the instruments depends on visible wear and potential damage. Practitioners must inspect each tool before use to detect cracks, breaks, or defects on the cutting edges. The technical design allows for complete reprocessing including cleaning, disinfection, and sterilization. These products are delivered non-sterile and must undergo a complete decontamination cycle before their first use.
What are the contraindications for the use of this kit?
The main medical contraindication associated with the use of this prophylaxis kit is known hypersensitivity or intolerance to metals. As the instrument is manufactured from medical stainless steel, contact with the patient may trigger a hypersensitivity reaction in sensitive individuals. The manufacturer Helmut Zepf stipulates that if such a reaction occurs during the procedure, the intervention must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to assess the patient's allergic history before any use. Furthermore, the use of instruments showing visible damage, such as blunt cutting edges or structural defects, is strictly prohibited to avoid any risk of tissue injury.
What are the maintenance and reprocessing precautions?
Maintaining the performance of this prophylaxis set relies on a rigorous reprocessing protocol. All instruments must be cleaned, disinfected, and sterilized before the first use, and then after each subsequent use. The manufacturer emphasizes the importance of verifying compatibility with other cleaning and disinfection products used in the practice. Due to the nature of the materials and the design of Helmut Zepf instruments, there is no predefined maximum number of sterilization cycles; however, functional wear determines the end of the product's life. It is imperative never to use worn or damaged instruments, especially those with breaks or defects on the active parts, to guarantee patient safety and the effectiveness of the clinical procedure.
Who is the manufacturer and what standards are respected?
The Bionik universal prophylaxis kit is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer in the dental sector ensures the production of devices compliant with safety and performance requirements. This product is classified as a Class I medical device according to current regulations. The manufacturing processes respect quality standards for medical stainless steel instruments. Each kit, identified by reference 24.990.60, is subject to strict controls before being placed on the market. Healthcare professionals can refer to the manufacturer's instructions to ensure use in accordance with the intended purposes and to maintain the safety level required for dental care.
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Specifications
| Manufacturer | Helmut Zepf |
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