Surgical Syndesmotome XTool - Helmut Zepf (17.008.06TI) - Delynov
The Syndesmotome XTool - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 17.008.06TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the XTool syndesmotome - Helmut Zepf?
The XTool syndesmotome, bearing reference 17.008.06TI, is a precision manual instrument developed by the manufacturer Helmut Zepf Medizintechnik GmbH. This medical device is manufactured from medical-grade stainless steel, ensuring compatibility with cleaning and sterilization protocols in the dental office. It belongs to the category of surgical consumables and is presented as a robust tool for practitioners performing extractions. This specific model is part of the XTool range, recognized for its design adapted to the requirements of modern oral surgery. It is delivered non-sterile and must undergo complete processing before its first use.
What are the clinical indications for this instrument?
The Helmut Zepf XTool syndesmotome is specifically indicated for exodontia procedures. Its intended purpose is to serve as a manual instrument for lifting teeth or residual dental roots at the time of extraction. In clinical practice, it is used by the dental surgeon to break ligament attachments and facilitate tooth luxation. This instrument is particularly useful in complex cases where roots are fractured or deeply anchored in the socket. Its use is strictly reserved for qualified healthcare professionals mastering dental surgery and extraction techniques.
What are the technical characteristics of the 17.008.06TI syndesmotome?
This Class I medical device is designed in medical stainless steel, a material chosen for its resistance and its ability to withstand repeated reprocessing cycles. The technical reference 17.008.06TI corresponds to a specific configuration of the Helmut Zepf XTool range. Due to its design and the materials used, the manufacturer specifies that there is no defined maximum limit for the number of achievable processing cycles, although the instrument must be inspected before each use to detect potential visible damage such as cracks, breaks, or defects on the cutting edges. It is imperative never to use a damaged product or one showing manifest wear.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of the XTool syndesmotome lies in the patient's potential hypersensitivity to metallic components. As the instrument is manufactured from medical stainless steel, a metal intolerance reaction may occur upon contact with tissues. If a hypersensitivity reaction is triggered during the intervention, the manufacturer Helmut Zepf stipulates that the procedure must be immediately stopped and necessary medical measures must be taken accordingly. It is therefore recommended to check the patient's allergic history before any surgical intervention involving this instrument.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before their first use as well as before each subsequent use. The reprocessing process must be complete to ensure patient safety and tool longevity. It is crucial to clean each product individually and check for the absence of visible damage such as cracks or defects on the sharp edges. Products are delivered non-sterile by Helmut Zepf Medizintechnik GmbH. The practitioner must also ensure compatibility with other products used during the intervention. Rigorous maintenance is the sine qua non condition for maintaining the instrument's performance in surgery.
Who is the manufacturer and what standards are respected?
The XTool syndesmotome is manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer respects strict manufacturing protocols to guarantee the quality of its manual instruments. As a Class I device, it meets the safety and performance requirements defined for this product category. Traceability is ensured by the reference 17.008.06TI. The use of this instrument is exclusively reserved for trained healthcare professionals, thus ensuring application in accordance with scientific data and manufacturer recommendations.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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