Cement spatula with octagonal handle - Helmut Zepf (26.130.01) - Delynov
The Spatule à ciment avec manche octogonal - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.130.01.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 26.130.01 cement spatula?
The Helmut Zepf cement spatula (reference 26.130.01) is a manual instrument specifically designed for the dental sector. Manufactured from medical stainless steel, it is distinguished by its octagonal handle which offers ergonomics adapted to the material preparation phases. This dental cement mixer allows for the handling of various pastes and powders to obtain homogeneous mixtures. As a Class I device, this instrument meets quality requirements for repeated use in the practice, subject to strict maintenance. Its robust design ensures efficient force transmission when working with high-viscosity materials.
What are the clinical indications for this instrument?
This dental mixing spatula is indicated for all preparation phases requiring manual mixing of two-paste or powder-liquid components. It is used in conservative surgery, prosthetics, and implantology to prepare permanent or temporary luting cements, cavity liners, and filling materials. Its use is strictly reserved for qualified healthcare professionals. It is used prior to the insertion of the material into the treatment area, ensuring that the chemical setting reaction begins on a perfectly mixed base, which is crucial for the final mechanical properties of the cement used.
What are the technical characteristics of the 26.130.01 spatula?
The Helmut Zepf dental cement spatula features technical characteristics focused on durability and functionality. It is forged from medical stainless steel selected for its corrosion resistance and compatibility with reprocessing processes. Reference code 26.130.01 designates a model equipped with an octagonal handle, a geometric shape chosen to prevent the tool from rolling on the work tray and to improve control during mixing. The instrument is delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use and between each patient.
What are the contraindications for the use of this spatula?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity to metals. If a patient has a known intolerance to medical stainless steel components, contact with the instrument may trigger a hypersensitivity reaction. In the event that such a reaction occurs during the procedure, the procedure must be immediately interrupted and necessary medical measures must be taken. It is therefore recommended to question the patient about their allergic history before any instrumental manipulation. Additionally, use of the instrument is prohibited if it shows visible damage such as cracks or breaks.
What are the maintenance and safety precautions?
To ensure care safety, this dental cement spatula must be inspected before each use for any signs of wear, corrosion, or deformation. The use of damaged products is strictly prohibited. The reprocessing process includes cleaning, disinfection, and sterilization, in accordance with the protocols in force in healthcare facilities. Although no maximum limit for treatment cycles is defined due to the robustness of the materials, compatibility with other cleaning products must be verified beforehand. Thorough cleaning is essential to remove any hardened cement residue that could compromise hygiene or the effectiveness of the subsequent mix.
Who is the manufacturer and what standards are met?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This product belongs to Class I according to medical device regulations. It is designed to meet the standards of professional manual dental instrumentation. The manufacturer emphasizes that its products are delivered non-sterile and require rigorous preparation before use. Compliance with cleaning and sterilization instructions is essential to maintain the instrument's conformity throughout its useful life. As a Class I instrument, it benefits from Helmut Zepf's technical expertise in medical stainless steel devices.
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Specifications
| Manufacturer | Helmut Zepf |
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