Swedish Model Needle Holder - Helmut Zepf (41.246.15TC) - Delynov
The Porte-aiguille modèle suédois - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.246.15TC.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf Swedish model needle holder?
The Helmut Zepf Swedish model needle holder, referenced under code 41.246.15TC, is a manual surgical instrument specifically designed for gripping and guiding suture needles. Manufactured from medical stainless steel, this Class I instrument meets the durability and resistance requirements necessary in a clinical environment. Its structure is optimized to offer a firm grip, preventing any needle slippage during trans-mucosal passage. This device is delivered non-sterile by Helmut Zepf Medizintechnik GmbH and requires a full cycle of cleaning, disinfection, and sterilization before its first use in the practice as well as between each patient.
What are the clinical indications for this Swedish needle holder?
This Swedish needle holder is indicated for all oral surgery, implantology, and periodontology interventions requiring soft tissue suturing. Its primary use lies in the secure holding and manipulation of suture needles to ensure precise coaptation of the wound edges. Whether for interrupted, continuous, or mattress sutures, this instrument allows the surgeon to pass through gingival tissues with controlled force. It is exclusively reserved for healthcare professionals trained in dental surgical techniques, thus guaranteeing manipulation in accordance with current clinical protocols.
What are the technical characteristics of this instrument?
The Helmut Zepf Swedish model needle holder (41.246.15TC) is distinguished by its high-quality medical stainless steel design. Although specific dimensions are not detailed, its Swedish-type morphology is recognized for its balance in the hand. As a Class I device, it is designed to withstand repeated reprocessing cycles without immediate loss of functionality. The manufacturer specifies that due to the design and materials, no maximum limit of processing cycles can be defined, although the instrument must be visually inspected before each use to detect any signs of wear, cracks, or defects on the active parts.
What are the contraindications for the use of this device?
The main medical contraindication related to the use of this needle holder is the patient's known hypersensitivity or intolerance to metals, particularly the medical stainless steel composing the instrument. A hypersensitivity reaction can be triggered during direct contact between the instrument and the tissues. If such a reaction occurs during the surgical act, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the procedure must be immediately stopped and the necessary medical measures must be taken. It is therefore recommended to check the patient's history regarding metal allergies before any surgical intervention.
What are the maintenance and reprocessing precautions?
The reprocessing of this Swedish needle holder is a critical step for the safety of care. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. Before sterilization, a thorough visual inspection is imperative to identify potential damage such as cracks or breaks. It is strictly advised against using a damaged or worn product. Compatibility with other cleaning and disinfection products must also be verified beforehand. Compliance with these safety instructions ensures not only asepsis but also the longevity of the stainless steel instrumentation.
Who is the manufacturer and what standards are respected?
The needle holder is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer ensures the traceability and compliance of its products with medical quality standards. As a Class I device, it meets the essential safety and performance requirements defined for reusable surgical instruments. Helmut Zepf's expertise in processing medical stainless steel guarantees a reliable instrument for demanding practitioners in dental and oral surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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