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Cleaning And Disinfection

Adequate cleaning and disinfection between patient cases are necessary to prevent disease transmission. All probes must be thoroughly cleaned prior to disinfection. The level of disinfection required is based on patient contact. 


Reprocessing Recommendation (Frequency)

After Each Use

1. Inspect the Vscan Air CL (See Inspecting the Vscan Air)


2. Clean the Vscan Air CL.


3. If required, clean the display device.

NOTE: The display device should be cleaned and/or disinfected according to the device manufacturer's recommendations. Please be aware that medical grade display devices often supports a wider range of cleaners and disinfectants compared to display devices for the consumer market.

4. If required, disinfect the Vscan Air CL. 

Ensure that the Vscan Air CL is properly cleaned and disinfected after each use and before storage in the protective case.

CAUTION : If any defects or damages are found on the Vscan Air probe, do not use it. Contact GE HealthCare service.
WARNING : Risk of Infection. ALWAYS clean and disinfect the probe between patients to the level appropriate for the type of examination.


Cleaning and Disinfection

Adequate cleaning and disinfection between patient cases are necessary to prevent disease transmission. All probes must be thoroughly cleaned prior to disinfection. The required level of disinfection is based on the type of tissue the probe will contact during use. These recommendations suit the Spaulding classification for intended use, and federal guidelines from FDA1 and CDC2 for proper processing of reusable medical instruments. Use the following guidance to determine the

appropriate level of disinfection based on system use.

1. FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,
March 17 2015.
2. CDC – Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.

Use

Method

Intact skin only

Cleaning followed by Intermediate-Level Disinfection (ILD)

Mucosal or non-intact skin

Cleaning followed by High-Level Disinfection (HLD) (soaking or use of a trophon® EPR or trophon®2)


Vscan Air is not intended for intra-operative use, it is also not intended for intra-cavitary use. It may be used during interventional procedures such as biopsy which based on proximity of the probe to the needle injection site it could get contaminated with blood or bodily fluids during use.


Good hand hygiene practice is highly recommended to help further reduce the risk of cross-contamination.

* For additional information about cleaning and disinfection, refer to the recommendations of the U.S Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Centers for Disease Control (CDC). For country-specific disinfection regulations, check with your local regulatory infection control authorities.
* Adequate cleaning and disinfection are essential to prevent disease transmission. It is the responsibility of the user to verify and maintain the effectiveness of the infection control procedures in use.


Chemicals Used for Efficacy Validation

The table below lists the products and intended use (cleaning, Intermediate-level disinfection, high-level disinfection) that were validated with the Vscan Air CL probe.


Product Type

Trade Name

Manufacturer

Active Ingredients

Cleaning (Wipe)

Sani-Cloth Prime Germicidal Disposable Wipe

PDI Healthcare

Isopropanol, Ethyl Alcohol (Ethanol), Didecyl dimethyl ammonium chloride

Cleaning (Soak)


Cidezyme/ Enzol
Advanced Sterilization Products (J&J)Proteolytic Enzymes

Intermediate-level Disinfection (wipe)

Sani-Cloth Prime Germicidal Disposable Wipe

PDI Healthcare

Isopropanol, Ethyl Alcohol (Ethanol), Didecyl dimethyl ammonium chloride

High-Level Disinfection (Solution)

Cidex OPA Solution

Advanced Sterilization Products (J&J)

Ortho-Phthalaldehyde

High-Level Disinfection (Machine)trophon EPR trophon2NanosonicsHydrogen peroxide

Chemicals used for Efficacy Validation with Vscan Air 


Special Label Designations, Warnings and Precautions

Never use thinner, benzene, abrasive cleaners, or other strong solvents, as these may cause damage to the Vscan Air Probe

 

Special Accessories

A trophon® Wireless Ultrasound Probe Holder is required to hold the Vscan Air probe in the trophon chamber. GE HealthCare offers this holder

NOTE
A validated, high-level disinfection process, combined with the use of a sterile gel and a probe cover/sheath is an accepted method of infection control for Ultrasound probes. Adequate records or a logbook detailing the time, date, disinfection method, and verification of disinfectant effectiveness or test results is recommended. For more information about establishing an evidence-based disinfection protocol for your practice, refer to the FDA, CDC, or the Joint Commission websites.


Disclaimer: The information herein is not intended to replace the product’s User Manual. Please consult the User Manual for comprehensive information and cautionary guidance about the product’s operation and use.

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