Spatula - Helmut Zepf (26.260.01)
The spatule - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.260.01.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf spatula (26.260.01)?
The Helmut Zepf spatula, referenced under code 26.260.01, is a manual instrument used in dental care. Manufactured by Helmut Zepf Medizintechnik GmbH, it is designed in medical stainless steel, a standard material for surgical instrumentation ensuring resistance to sterilization processes. This tool is categorized as a reusable consumable (CONSO) for odontological practice. As a stainless steel dental spatula, it provides the necessary rigidity for handling various chemical or biological compounds used at the chairside, while meeting biocompatibility requirements for temporary contact with tissues or restorative materials.
What are the clinical indications for this dental spatula purchase?
The purchase of this dental spatula is indicated for any procedure requiring a manual instrument for mixing or applying materials. In oral surgery and restorative dentistry, it is mainly used for the preparation of cements, resins, or filling materials. Its primary function is to ensure perfect homogeneity of preparations before they are placed in the mouth. Although the manufacturer Helmut Zepf defines it broadly as a manual dental instrument, its use is common during pre-implant preparation phases or conservative care where precision in dosage and spreading is required for the clinical success of the intervention.
What are the technical characteristics of this instrument?
The Helmut Zepf spatula (26.260.01) is characterized by its high-quality medical stainless steel construction. It belongs to Class I of medical devices according to current regulations. The instrument is delivered non-sterile, which requires a strict protocol of cleaning, disinfection, and sterilization before the first use and between each patient. Its monobloc design facilitates maintenance and limits debris retention areas. The manufacturer does not define a maximum limit of processing cycles, with the product's end-of-life being determined by the appearance of visible damage such as cracks or deformations on the active parts.
What are the contraindications for the use of this dental care spatula?
The main contraindication related to the use of this dental care spatula is known patient hypersensitivity or intolerance to metals, specifically medical stainless steel. If an allergic reaction or hypersensitivity is triggered upon contact with the instrument, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to question the patient about their allergic history before any intervention. Furthermore, the use of an instrument showing visible defects, breaks, or excessive wear is strictly prohibited to ensure the safety of care.
What are the maintenance and reprocessing precautions?
The reprocessing of the Helmut Zepf spatula must follow a rigorous protocol. Before each use, the instrument must be cleaned, disinfected, and sterilized. It is imperative to visually inspect the device to detect any trace of corrosion, crack, or deformation. Cleaning must be complete to remove any residue of care material that could compromise the sterility or effectiveness of the tool. Due to its stainless steel composition, the compatibility of the disinfection products used should be checked to avoid premature degradation. This device is exclusively reserved for use by qualified healthcare professionals mastering asepsis protocols in surgical environments.
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 recognized manufacturer in the dental sector guarantees production in compliance with Class I requirements for manual instruments. The product is identified under technical reference 26.260.01. In accordance with European directives on medical devices, this instrument meets the safety and performance standards applicable to its regulatory class. Practitioners can refer to the instructions provided by Helmut Zepf for details concerning cleaning and sterilization, thus ensuring full compliance with health safety requirements in dental offices or hospital environments.
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Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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