MEGA mirror. Stainless Figure 5 - Helmut Zepf (24.071.24) - (box of 12) Delynov
The Miroir MEGA. Inoxydable Figure 5 - Helmut Zepf- (lot de 12) Delynov is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.071.24.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf MEGA mirror?
The MEGA mirror, referenced under code 24.071.24, is an inspection instrument designed by Helmut Zepf Medizintechnik GmbH. This Stainless Figure 5 device is manufactured from medical stainless steel, ensuring a structure adapted to the requirements of the oral environment. It is delivered in packs of 12 units by Delynov to meet the needs for frequent replacement of diagnostic equipment. As a Class I device, it meets basic safety standards for non-invasive instruments used in daily practice. Its robust design allows for precise handling during the examination of soft and hard tissues.
What are the clinical indications?
The clinical indications for this Helmut Zepf brand mirror primarily concern diagnosis and visual intra-oral inspection. It is specifically indicated for the observation of areas that cannot be seen directly by the practitioner. Its use is essential during initial assessments, post-operative checks in implant or periodontal surgery, and for any procedure requiring an indirect view of palatal, lingual faces, or posterior sectors. The instrument facilitates the detection of pathologies or the monitoring of healing in the recesses of the oral cavity where direct visual access is hindered by the patient's anatomy.
What are the technical characteristics?
The MEGA mirror (24.071.24) is characterized by its manufacture in medical grade stainless steel, a material chosen for its resistance to decontamination cycles. This Figure 5 model is a standard in rotary and examination instrumentation. Helmut Zepf delivers these products non-sterile, which requires a strict processing protocol before the first use. The instrument's design does not define a maximum limit for processing cycles, although visual examination before each use is imperative to detect any cracks, breaks, or defects on the edges. Its compatibility with other handles and accessories must be verified beforehand by the professional.
What are the contraindications for use?
The main medical contraindication documented by the manufacturer Helmut Zepf Medizintechnik GmbH is 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 examination, the procedure must be stopped immediately and necessary clinical measures must be taken. It is therefore recommended to question the patient about their history of allergies to metallic components before any intra-oral manipulation with this diagnostic instrument.
What are the maintenance and reprocessing precautions?
Being a non-resorbable and reusable instrument, the MEGA mirror requires a complete reprocessing protocol. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to clean the product before proceeding with sterilization to ensure the effectiveness of the cycle. The practitioner must inspect each mirror to identify visible damage such as cracks or marked wear. The use of damaged products is strictly prohibited. Due to the materials used, the number of processing cycles is not arbitrarily limited but depends on the physical condition observed during inspection.
Who is the manufacturer and what standards are respected?
The MEGA mirror is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Germany. This medical device is classified as Class I according to current regulations (MDC0483). Compliance with manufacturing standards by Helmut Zepf ensures that the instrument is suitable for professional use in surgical and dental environments. The products are delivered non-sterile and must undergo sterilization validation by the end user. This device is exclusively reserved for trained healthcare professionals, ensuring use in accordance with the intended purposes and safety instructions issued by the manufacturer for patient protection.
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Specifications
| Manufacturer | Helmut Zepf |
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