DIAMANT ROND 018C - Helmut Zepf
The Diamant Rond 018C - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 08.906.018C.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Diamant Rond 018C Helmut Zepf?
The Diamant Rond 018C, referenced under code 08.906.018C by Helmut Zepf, is a manual instrument designed for dental surgery. This device, often referred to as a diamond ball bur or dental ball bur, is manufactured from high-quality medical stainless steel. It is specifically developed to meet the needs of dental surgeons and implantologists during manipulations requiring fine and localized abrasion. This product belongs to the consumables category (CONSO) and is part of the rotary and manual instrument catalog of the manufacturer Helmut Zepf Medizintechnik GmbH.
What are the clinical indications?
The Diamant Rond 018C is indicated as a manual dental instrument for various interventions in oral, periodontal, and implant surgery. Its primary use involves the treatment of hard surfaces where a milling or grinding action is required. Although the raw MDR text defines it generally as a manual dental instrument, its profile as a diamond ball bur makes it suitable for cavity preparation, implant site development, or the smoothing of bone ridges. It is exclusively reserved for use by qualified healthcare professionals in clinical or hospital environments.
What are the technical characteristics?
This instrument bears the technical reference 08.906.018C. It is manufactured from medical stainless steel, a material chosen for its resistance and compatibility with reprocessing protocols in surgical environments. The device is classified as a Class I instrument according to current regulations. It is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, which necessitates a rigorous preparation protocol before the first use. The design of the instrument does not define a maximum limit for reprocessing cycles, as this depends on visible wear and the integrity of the active parts during inspection by the practitioner.
What are the contraindications for use?
The main contraindication for using the Diamant Rond 018C from Helmut Zepf is known hypersensitivity or intolerance of the patient to metals, particularly medical stainless steel. If a hypersensitivity reaction is triggered upon contact with the instrument, the procedure must be immediately discontinued and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use an instrument showing visible damage, such as cracks, breaks, or defects on the cutting edges, to avoid any risk of intraoperative complications or unintentional tissue injury.
What are the maintenance and sterilization precautions?
Like any Helmut Zepf instrument delivered non-sterile, the Diamant Rond 018C must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use and after each subsequent use. It is crucial to check for the absence of visible damage and wear, such as cracks or cutting defects, before each intervention. The use of damaged or worn products is strictly prohibited. Due to its design and the materials used, the number of reprocessing cycles is not fixedly limited but remains subject to the clinical evaluation of the instrument's condition by the healthcare professional.
Who is the manufacturer and what standards are met?
The Diamant Rond 018C is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device complies with the regulations relating to Class I devices. The manufacturer guarantees that the instrument is designed for strict professional use. Although specific CE marking is not detailed in the source data, the product meets the safety requirements related to the medical stainless steel used for its manufacture. Compatibility with other products used during surgery must be verified beforehand by the end user to ensure patient safety.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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