Description

The ENVISION GELFREE PROBE COVER by CIVCO is an innovative solution designed to enhance ultrasound procedures by eliminating the need for traditional ultrasound gel. This single-use, gel-free system serves as both a probe cover and scanning pad, activated with a sterile liquid such as saline, providing a seamless and clean ultrasound experience.

Key Features

• Gel-Free Operation: The cover facilitates completely gel-free procedures, reducing the risk of contamination and simplifying probe cleaning.
• Viral Barrier: It acts as an effective barrier against viruses, bacteria, and bloodborne pathogens, enhancing infection control.
• Material and Sterility: Made from CIV-Flex material and available in various sizes, the cover is not made with natural rubber latex and comes in both sterile and non-sterile versions.

Design and Compatibility

• Easy Application: The telescopic folding and quick-peel silicone liner ensure easy application and secure adhesion to the probe or patient’s skin.
• Wireless Compatibility: Some versions include a tape strip compatible with wireless transducers.

Infection Control

The absence of gel residue simplifies pre-cleaning before high-level disinfection, significantly reducing the risk of healthcare-associated infections (HAIs). The cover has been independently tested under the ASTM F1671 protocol, proving effective against bloodborne pathogens for viruses 27 nm and larger, such as SARS coronavirus, HPV, and HIV.

Intended Use

Ideal for a variety of ultrasound-guided interventions, including:

• Peripheral IV insertions
• Central venous catheters (CVCs)
• Nerve blocks
• Thyroid fine needle aspirations (FNAs)
• Scanning non-intact skin or post-surgical wound sites

Benefits

The ENVISION GELFREE PROBE COVER enhances specimen quality by eliminating gel-related artifacts, improves workflow efficiency, and provides robust protection against cross-contamination. It is part of CIVCO’s comprehensive infection prevention solutions, offering a safer alternative for maintaining sterile conditions during both invasive and non-invasive ultrasound procedures.

Regulatory Status

Currently, the product is pending U.S. FDA 510(k) clearance. It is not cleared or approved by the FDA as a device to prevent viral or bacterial infections in healthcare settings. Despite this, it remains a valuable tool in reducing potential infection risks associated with ultrasound procedures.