Spatula Fig.2 - Helmut Zepf (26.260.02) - Delynov
The spatule Fig.2 - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.260.02.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Helmut Zepf |
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What is the Fig.2 Helmut Zepf (26.260.02) spatula?
The Fig.2 spatula, bearing technical reference 26.260.02, is a high-quality manual instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed for daily practice in the clinic, this dental surgery spatula is structured from medical stainless steel, a standard material for surgical instrumentation. This device belongs to the category of reusable consumables (CONSO) and features an ergonomic shape adapted for fine manipulations in the mouth. As a non-sterile instrument upon delivery, it requires a complete cleaning and sterilization protocol before its first use, in accordance with hospital and clinical hygiene standards.
What are the clinical indications for this instrument?
The intended use for this Helmut Zepf manual instrument is primarily focused on dental care and oral surgery. As a modeling spatula, it is indicated for the manipulation of various materials, whether cements, composites, or bone grafting materials during implant or periodontal procedures. Its design allows for controlled application and precise smoothing of surfaces. It is intended exclusively for qualified healthcare professionals capable of mastering the technical gestures associated with dental restoration and alveolar reconstruction surgery.
What are the technical characteristics of the Fig.2 spatula?
The Fig.2 spatula (reference 26.260.02) is distinguished by its medical stainless steel manufacturing, guaranteeing the necessary resistance to repeated reprocessing cycles. Although the maximum number of processing cycles is not defined due to its robust design, the instrument must be inspected before each use. The practitioner must check for the absence of visible damage such as cracks, breaks, or defects on the working parts. Its compatibility with other products in the Helmut Zepf range must also be validated beforehand to ensure optimal synergy during complex interventions.
What are the contraindications for the use of this instrument?
The main medical contraindication mentioned by the manufacturer Helmut Zepf concerns known hypersensitivity or metal intolerance 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 intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to validate the patient's history regarding metal allergies before any clinical manipulation with this instrument.
What are the maintenance and reprocessing precautions?
As a non-resorbable and reusable device, the Fig.2 spatula must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before each use, including the first. Since Helmut Zepf products are delivered non-sterile, strict compliance with reprocessing protocols is essential to prevent risks of cross-contamination. It is imperative never to use damaged or worn products. Wear on edges or the presence of micro-cracks compromise not only the modeling efficiency but also patient safety. Maintenance must follow the manufacturer's specific recommendations for stainless steel.
Who is the manufacturer and what standards are respected?
This device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The Fig.2 spatula (26.260.02) is classified as a Class I medical device according to current regulations. It meets the safety and performance requirements for manual dental instruments. The manufacturer emphasizes that the use of this instrument is strictly reserved for healthcare professionals. Following safety instructions, particularly systematic cleaning before use and verification of the steel's integrity, ensures compliance with the quality standards required in the dental surgery sector.
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