Transducer and System Care

Choosing the Correct Transducer Care Method

To choose an appropriate care method for your transducer, you first must determine the classification of the transducer, based on its use. The care method for your transducer determines the appropriate disinfectant for your transducer. For details about compatible disinfectants, see Disinfectants. Always follow the manufacturer’s instructions when using disinfectants and cleaning solutions.

Transducers must be cleaned after each use. Cleaning the transducer is an essential step before effective disinfection or sterilization.

Non-TEE Transducer Use

Example

Classification

Care Method

Contacts intact skin
Curved, linear, xMatrix and sector transducers
Noncritical
Contacts mucous membranes
Endocavity
Semi-critical
Enters otherwise sterile tissue
Intraoperative and laparoscopic
Critical

TEE Transducer Use

Example

Classification

Care Method

Contacts mucous membranes
Transesophageal (TEE)
Critical

 

(1) High-level disinfection and the use of a sterile gel and a transducer cover, as described in the instructions provided with the transducer cover, is an accepted method of infection control for ultrasound transducers. See the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," updated September 9, 2008, at the following website.

NOTE

All imaging transducers are rated at a minimum IPX7 in accordance with IEC 60529, “Degrees of Protection Provided by Enclosures (IP code).” This rating indicates that the device is protected against the effects of immersion. Continuous wave (non-imaging) transducers are rated IPX1. This rating indicates that the device is protected against the effects of vertically falling water. For all TEE transducers, the control module is rated IPX1, while the endoscope is rated IPX7, in accordance with IEC 60529.

 

Warnings and Cautions

These warnings and cautions must be observed during all cleaning, disinfection, and sterilization procedures.

 

WARNINGS

  • Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
  • If a pre-mixed solution is used, be sure to observe the solution expiration date.
  • Transducers must be cleaned after each use. Cleaning the transducer is an essential step before effective disinfection or sterilization. Be sure to follow the manufacturer’s instructions when using disinfectants.

 

CAUTIONS

  • Attempting to clean or disinfect a transducer, cable, or connector by using a method other than the procedures on this website can damage the device and voids the warranty.
  • Do not allow sharp objects, such as scalpels or cauterizing knives, to touch transducers or cables.
  • When handling a transducer, do not bump the transducer on hard surfaces.
  • On TEE transducers, do not bend or crimp the gastroscope (flexible shaft) or cable.
  • Do not use a surgeon’s brush when cleaning transducers. Even the use of soft brushes can damage transducers.
  • Do not use a brush on the connector label.
  • Do not use paper products or products that are abrasive when cleaning the transducer. They damage the soft lens of the transducer.
  • During cleaning, disinfection, and sterilization, orient the parts of the transducer, connector, or cable that must remain dry higher than the wet parts, until all parts are dry. This helps keep liquid from entering unsealed areas of the transducer.
  • Do not allow any type of fluid to enter the connector. Ensure that fluid does not enter through the strain relief, through the connector, through the electrical contacts, or through the areas surrounding the locking-lever shaft and the strain relief. Fluid in the connector may void the device warranty.
  • Be sure to use the proper concentration of enzymatic cleaner and rinse thoroughly.
  • Before storing transducers, ensure that they are thoroughly dry. If it is necessary to dry the transducer lens after cleaning, use a soft cloth and a blotting motion, instead of a wiping motion.
  • The use of 70% isopropyl alcohol (rubbing alcohol) and alcohol-based products on all transducers is restricted. On non-TEE transducers, the only parts that may be cleaned with isopropyl alcohol are the connector housing and the transducer housing and lens. On TEE transducers, the only parts that may be cleaned with isopropyl alcohol are the connector housing and the handle. Ensure that the solution is only 70% alcohol or less. Do not wipe any other part of a transducer with isopropyl alcohol (including cables or strain reliefs), as it can damage those parts of the transducer. This damage is not covered by the warranty or your service contract.

 

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