Swerv 3 Barrier Sleeves
The Swerv 3 Barrier Sleeves is a medical device manufactured by le fabricant.
- Compliance: Medical device Class I.
- Manufacturer: le fabricant.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Hu-Friedy |
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What are Swerv 3 Barrier Sleeves?
Swerv 3 Barrier Sleeves, marketed under the brand Hu-Friedy, are disposable protective devices belonging to the CONSO category. Designed specifically for the medical environment, these sleeves serve as a protective barrier for care equipment. They come in the form of a dental protection cover adapted to the dimensions of ultrasound-type devices. This product is manufactured by the manufacturer Hu-friedy, based in Chicago, USA. As a Class I device, it meets the basic regulatory requirements for use in oral surgery or periodontics practices. Its structure allows for rapid placement on the equipment to maintain a clean working environment during interventions.
What are the clinical indications?
The use of the Swerv 3 Barrier Sleeves scaler protection sleeve is indicated during all clinical procedures involving the use of ultrasonic inserts. In oral surgery, periodontology, or during prophylactic hygiene care, these protections are essential for covering the body of the device. The brand Hu-Friedy offers this solution to help practitioners isolate their equipment from splashes and repeated manual contact. The official indication provided by the manufacturer specifies that this product is strictly reserved for healthcare professionals. Its systematic application allows for compliance with the hygiene protocols in force within dental and implant care facilities.
What are the technical characteristics?
The Swerv 3 Barrier Sleeves from the brand Hu-Friedy are classified as a Class I medical device. Although exact dimensions are not specified in the technical data, they are designed to adapt to the morphology of standard ultrasonic scalers. This is a single-use ultrasound protection cover, which guarantees simplified equipment management between each patient. The manufacturer Hu-friedy developed this product to be easy to install and remove, without interfering with the practitioner's handling of the instrument. This type of sterile dental equipment sleeve is an essential consumable for protecting non-autoclavable surfaces or for limiting the disinfection load on handpieces.
What are the contraindications for use?
According to the information provided by the manufacturer Hu-friedy, there are no specific medical contraindications listed for the use of Swerv 3 Barrier Sleeves. However, it is imperative to respect the use intended by the manufacturer. This device is exclusively reserved for qualified healthcare professionals. Misuse or use not in accordance with the instructions in the manual could compromise its effectiveness as a protective barrier. As with any Class I device, the practitioner must ensure the integrity of the scaler protection cover before each use. In the event of a visible tear or perforation before or during care, the sleeve must be replaced immediately to ensure continuity of protection.
What are the precautions for use for this non-absorbable device?
Swerv 3 Barrier Sleeves are non-absorbable devices intended for external use on equipment and not on human tissue. The precautions for use stipulate that the practitioner must read the manual carefully before any use. As a single-use product from the brand Hu-Friedy, it must under no circumstances be cleaned, disinfected, or reused for a second patient. Reusing this dental protection cover could lead to risks of cross-contamination. After each care procedure, the sleeve must be carefully removed and disposed of in accordance with the protocols for the disposal of healthcare waste with infectious risks (DASRI) in force in the dental office or clinic.
Who is the manufacturer and what standards are respected?
The official manufacturer of the Swerv 3 Barrier Sleeves is Hu-friedy, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This product benefits from the Class I regulatory classification. Compliance with this class certifies that the device meets the safety and performance requirements defined for medical consumables of this type. The brand Hu-Friedy thus ensures the distribution of a product compliant with the standards expected by dental surgery professionals. Users are reminded that all handling must be carried out by trained personnel and that consultation of the instructions for use is mandatory before implementing the device to guarantee optimal protection of the scaling equipment.
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