Combined retractor and cheek retractor - Helmut Zepf (37.440.00) - Delynov
The Écarteur et écarteur de joue combiné - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 37.440.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf combined retractor and cheek retractor?
The Helmut Zepf combined retractor and cheek retractor, referenced under code 37.440.00, is a manual dental instrument designed for tissue retraction. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device combines two functions in a single instrument to optimize ergonomics during procedures. It allows the practitioner or assistant to maintain a clear surgical field by retracting both the cheeks and soft tissue flaps. This equipment belongs to the surgical instruments category (INSTRU) and is delivered in a non-sterile state, requiring a complete preparation cycle before any clinical use.
What are the clinical indications for this combined retractor?
This combined retractor is indicated for all dental and oral surgery procedures requiring increased visibility and unobstructed access to surgical sites. Its use is particularly relevant in implantology, periodontology, and during complex extractions. As a combined surgical retractor, it serves to retract soft tissues to protect adjacent structures during the use of rotary or manual instruments. The intended purpose is to serve as a manual dental instrument to facilitate exposure of treatment areas. Its specific design allows precise manipulation to adapt the tension exerted on the cheek and surrounding tissues according to the needs of the procedure.
What are the technical characteristics of instrument 37.440.00?
The Helmut Zepf instrument reference 37.440.00 is characterized by its manufacture in medical stainless steel, a material chosen for its resistance to repeated sterilization cycles. Its combined design incorporates polished working surfaces to minimize trauma to the mucous membranes. Although the manufacturer does not define a strict maximum limit for treatment cycles due to the robustness of the materials used, the longevity of the device depends on rigorous maintenance. It is imperative to check for the absence of visible damage, such as cracks, breaks, or defects on the edges, before each intervention. This device is exclusively reserved for use by qualified healthcare professionals.
What are the contraindications for the use of this instrument?
The main contraindication to the use of this retractor is known hypersensitivity or intolerance of the patient to metals, particularly to the medical stainless steel used in its composition. A hypersensitivity reaction may be triggered upon direct contact with the instrument. The manufacturer Helmut Zepf specifies that if such a reaction occurs, the procedure must be immediately stopped and necessary medical measures must be taken. Furthermore, the use of an instrument showing visible signs of wear, cracks, or surface defects is strictly prohibited to avoid any risk of injury or cross-contamination.
What are the maintenance and sterilization precautions?
Like any non-sterile Class I instrument, this retractor must strictly follow a reprocessing protocol. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the very first use, as well as after each subsequent use. Cleaning must be complete to remove all biological residue before the sterilization phase. It is essential to check the condition of the medical stainless steel after each cycle to detect any damage or corrosion. Compatibility with other cleaning and disinfection products must also be verified beforehand to preserve the integrity of the instrument over the long term.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. The manufacturer is recognized for its expertise in the production of high-precision dental instruments. This device is classified as a Class I instrument according to current medical device regulations. Compliance with safety and performance requirements is ensured by adherence to the rigorous manufacturing protocols of Helmut Zepf. Products are delivered non-sterile and their use is strictly reserved for healthcare professionals, thus guaranteeing an application consistent with clinical standards of dental surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |