Chemicals Used For Efficacy Validation; Covering The Transducer Using A Sterile, Protective Sheath - GE Voluson Swift Instructions For Use Manual

Chemicals Used for Efficacy Validation

Product Type
Cleaning (Wipe)
Enzymatic Detergent
(Soak)
Intermediate-level
Disinfectant (wipe)
High-level
Disinfectant (Soak)

Covering the Transducer using a Sterile, Protective Sheath

Note
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4
probe in a storage cabinet with filtered air flow and/or by using a disposable storage
cover placed over the probe
The table below lists the products and intended use (clean, Intermediate-Level Disinfection,
High-Level Disinfection) that were validated.
Trade Name
Oxivir® Tb
Enzol® (Cidezyme®)
MetriZyme™
Prolystica® 2X
Concentrate Presoak
& Cleaner
Oxivir® Tb
Cidex® OPA
McKessen OPA/28
Table 5-3 Chemicals used for Efficacy Validation
A full list of chemicals tested for compatibility is available at the GE Probe Web Site.
Caution
Protective barriers may be required to minimize disease transmission. Probe sheaths are
available for use with all clinical situations where infection is a concern. Use of legally
marketed, sterile probe sheaths is recommended* for intra-cavitary and intra-operative
procedures.
1. Place an appropriate amount of gel inside the protective sheath and/or on the transducer
face.
Failure to use imaging gel may result in poor image quality.
2. Insert transducer into sheath, making sure to use proper sterile technique*. Pull cover
tightly over transducer face to remove wrinkles and air bubbles, taking care to avoid
puncturing the sheath.
* The use of a sterile sheath is recommended for every semi-critical use of the probe.
Endoscopic, rectal, and transvaginal probes should be used with a single-use sterile
sheath. (Market Clearance of Diagnostic Ultrasound Systems and Transducers, FDA
June 27, 2019)
Manufacturer Minimum Contact
Diversey N/A
Advanced Sterilization 1-Minute Soak
Products® (J&J)
Metrex™
Steris
Diversey 10-Minute Exposure
Advanced Sterilization 10-Minute Soak
Products® (J&J)
McKesson
Probes and Biopsies
Active Ingredient
Time
Hydrogen Peroxide
Proteolytic Enzymes
Hydrogen Peroxide
Ortho-phthalaldehyde
5-15