Aspiration Pouch 1.5 liters - Medela - Delynov

What is the 1.5 litres suction bag - Medela - Delynov?

The 1.5 litres suction bag marketed by the Marque is a Class I medical device designed for fluid management during surgical procedures. Developed by the manufacturer Medela, this single-use solution integrates perfectly into medical suction protocols, particularly for Vario type systems. This consumable (category CONSO) allows for the secure collection of secretions and biological fluids. The use of these single-use bags guarantees optimal hygiene within the dental office or clinic, limiting the risks of cross-contamination between patients. This equipment is specifically intended for healthcare professionals demanding constant reliability during their operative acts.

What are the clinical indications for this device?

The clinical indications for the 1.5 litres suction bag from the Marque primarily concern oral surgery, implantology, and periodontology. This device is indicated for the collection and evacuation of biological fluids generated during surgical procedures. As equipment intended for healthcare professionals, it is used in conjunction with a compatible surgical aspirator to maintain a clear and unobstructed surgical field. Its use is strictly reserved for trained practitioners, in accordance with the recommendations of the manufacturer Medela. It is imperative to read the instructions carefully before any implementation to ensure that the device meets the specific needs of the planned intervention.

What are the technical characteristics of this suction bag?

This suction bag is characterized by a capacity of 1.5 litres, offering a volume adapted to standard and complex dental surgery interventions. Produced by the manufacturer Medela, this device belongs to the CONSO category and benefits from a Class I regulatory classification. Its single-use design simplifies post-operative cleaning processes by eliminating the sterilization steps for containers. The Marque ensures the distribution of this robust equipment, designed to withstand the suction pressures required in a clinical environment. Each unit is subject to rigorous controls to guarantee the tightness and safety of the storage of aspirated fluids throughout the duration of the surgical act.

What are the contraindications for the use of this equipment?

The contraindications relating to the use of the 1.5 litres suction bag primarily concern use by unqualified personnel. This device is exclusively reserved for healthcare professionals. It must not be used if the packaging is damaged or if the integrity of the bag appears compromised, in order to avoid any leakage of biological fluids. Furthermore, it is contraindicated to reuse this equipment, as it is strictly single-use. Any attempt at resterilization could alter the physical properties of the plastic and compromise the safety of the patient and the practitioner. Compliance with the instructions provided by Medela in the included instructions for use is mandatory to prevent any technical incident.

What are the precautions for use and warnings?

The precautions for use for this device from the Marque require scrupulous adherence to the instructions appearing in the instructions for use included in the packages of each product. It is essential to read the manual carefully before installation on the aspirator. Professionals must ensure the technical compatibility between the 1.5 litres bag and the suction system used. As with any Class I device, careful handling is required to avoid perforations. After use, the bag must be disposed of according to the protocols for processing infectious clinical waste (DASRI). The manufacturer Medela, based in Switzerland, emphasizes that this equipment is intended only for professional use in a controlled medical environment.

Who is the manufacturer and what standards are respected?

The official manufacturer of this device is Medela, whose head office is located at Lättichstrasse 4B, 6340 Baar, Switzerland. This product is classified as a Class I medical device, meeting the regulatory requirements in force for this category of consumables. The Marque offers this equipment in compliance with the quality standards expected by dental surgeons. Technical references, such as G2S 011634 0169 Rev. 02, attest to the regulatory monitoring of the product. Users are invited to systematically refer to the technical documentation provided to guarantee use in accordance with safety standards. Traceability and manufacturing quality are at the heart of the design of these suction bags to guarantee reliable performance in the office.

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Surgical medical consumables play a decisive role in operative safety.