X1 Mega Stainless Mirror Fig.4 - Helmut Zepf (24.071.22.) - Delynov
The X1 Miroir Méga Inoxydable Fig.4 - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.071.22.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Helmut Zepf |
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What is the Helmut Zepf Mega Stainless Steel Fig.4 mirror?
The X1 Mega Stainless Steel Fig.4 Mirror, referenced under code 24.071.22., is a diagnostic instrument manufactured by Helmut Zepf Medizintechnik GmbH. This stainless steel dental mirror is designed to provide sharp reflection during clinical examinations. Its structure is based on the use of medical grade stainless steel, ensuring resistance to the repeated reprocessing cycles required in practice. As a Class I medical device, it meets regulatory requirements for safe use in surgical and dental environments, allowing for the exploration of oral cavity areas that escape the practitioner's direct vision.
What are the clinical indications for this stainless steel dental mirror?
This Helmut Zepf device is specifically indicated for visual intra-oral inspection. In dentistry and oral surgery, its intended purpose is clinical diagnosis. It allows the healthcare professional to visualize anatomical areas, soft tissues, or dental structures that cannot be observed directly. Its use is fundamental during initial assessments, post-operative checks, or during active treatment phases to ensure precise monitoring of the intervention site. It is a versatile diagnostic tool adapted to the requirements of daily practice in implantology and periodontology.
What are the technical characteristics of model 24.071.22.?
The Mega Stainless Steel Fig.4 mirror is distinguished by its manufacture in medical stainless steel, a material chosen for its durability and compatibility with strict hygiene protocols. Bearing technical reference 24.071.22., this instrument is delivered non-sterile and requires a complete preparation cycle before its first use and between each patient. The design of the instrument by Helmut Zepf Medizintechnik GmbH does not define a maximum limit for processing cycles, as the service life depends on materials and maintenance. It is imperative to check for the absence of visible damage, such as cracks or surface defects, before any use.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this stainless steel dental mirror concerns known hypersensitivity to metallic components. The manufacturer states that metal intolerance in the patient can trigger a hypersensitivity reaction upon contact with the medical stainless steel instrument. If such a reaction occurs during the examination or procedure, use must be immediately discontinued and necessary medical measures must be taken. It is the practitioner's responsibility to check the patient's allergic history before the intervention to prevent any adverse side effects related to the instrument's composition materials.
What are the maintenance and sterilization precautions?
Like any Helmut Zepf instrument, this mirror must be rigorously cleaned, disinfected, and sterilized before the first use and after each subsequent use. The reprocessing process must include thorough cleaning to remove any residue before sterilization. It is crucial to inspect the instrument for any wear, breakage, or defects on the edges. The use of damaged products is strictly prohibited. Although the stainless steel design allows for many processing cycles, the practitioner must validate compatibility with other cleaning products and devices used within the dental practice.
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 mirror is classified as a Class I medical device according to current regulations. The manufacturer emphasizes that the use of this instrument is strictly reserved for qualified healthcare professionals. Compliance with the cleaning and sterilization protocols described by Helmut Zepf is essential to guarantee patient safety and tool longevity. Each unit is identified by a precise reference ensuring the traceability of the equipment within the Delynov supply chain.
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