Transducer Covers CIV-Flex^™ & TEE CIV-Flex Covers

• Covers serve as an effective viral barrier for protection against microbial migration, including viruses, bacteria and bloodborne pathogens.¹
• Specifically tested by an independent laboratory under protocol complying with ASTM F1671 to evaluate the barrier properties to penetration by bloodborne pathogens using viral penetration as a test system. Based on the results of the study, CIVCO ultrasound probe covers provide effective barrier to the penetration of microbial migration.¹
• CIVCO covers provide protection against human viruses with an effectiveness of 27 nanometers (nm) and above. Human viruses larger than 27nm include, but are not limited to:
  • SARS coronavirus
  • Human papillomavirus (HPV)
  • Hepatitis B virus
  • Yellow fever/Zika virus
  • Junin arenavirus/Lassa virus
  • Ebola virus
  • Rotavirus
  • Human immunodeficiency virus (HIV)
  • Hantaan virus
  • Herpes virus
  • Measles virus.¹
• Sterile transducer covers are useful and safe alternatives to sterile working conditions during invasive, interventional and non-invasive ultrasound procedures.³
• Transducer cover use lowers contamination levels in interventional and endocavity procedures where skin is not intact.²

Customers are advised this testing does not imply that tested products will prevent an infection resulting from exposure to blood-borne pathogens. Additionally, this testing does not imply protection from acquiring a disease-state associated with such viral exposure. CIVCO transducer covers have not been cleared or approved by the FDA as devices that prevent healthcare workers from acquiring viral or bacterial infections.

Sources

1. https://viralzone.expasy.org/678
2. Infection Prevention and Ultrasound Probe Decontamination Practices in Europe: a Survey of the European Society of Radiology, C. Nyshen. 2016
3. Sterile Working in Ultrasonography: The Use of Dedicated Ultrasound Covers and Sterile Ultrasound Gel, Peter Marhofer, Department of Anesthesia, Intensive Care Medicine and Pain Therapy, Medical University of Austria and Gerhard Fritsch, Department of Anesthesiology, Perioperative Medicine and Critical Care Medicine, Paracelsus Medical University, Salzberg, Austria, 2016.
4. Analysis of the Integrity and Breakage Rate of Covers used in Ultrasound Transvaginal Exams, Jocelyne M Basseal¹, Susan Campbell Westerway² and Joh A Hyet³, ^{1Australasian Society for Ultrasound in Medicine (ASUM), Sydney NSW Australia, , 2Australasian Society for Ultrasound in Medicine (ASUM), Sydney NSW Australia, , 2AFaculty of Dentistry & Health Sciences, Charles Sturt University NSW, Australia, , 3ADepartment of High-Risk Obstetrics, Royal Price Alfred Hospital, Sydney NSW Australia, 2019.}