Transducer and System Care

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Final CEE consent

Cleaning, Disinfecting, and Sterilizing TEE Transducers

The following topics explain how to clean, disinfect, and sterilize TEE transducers. To determine the appropriate care method for your transducer, see Choosing the Correct Transducer Care Method.

Upon receiving your new transducer, disinfect it before performing the first study. Clean and disinfect the transducer immediately after each use to protect patients and personnel from pathogens. Establish and clearly post a cleaning procedure that includes the following steps.

For non-TEE transducer care instructions, see Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers.

The following figure identifies the components of TEE transducers.

Warnings and Cautions for TEE Transducer Care
Warnings and Cautions for TEE Transducer Care
Warnings and Cautions for TEE Transducer Care

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.

Cautions for TEE Transducer Disinfection and Sterilization

Obey the following safety precautions when disinfecting TEE transducers:

CAUTIONS

Never sterilize the transducer with autoclave, gamma-radiation, gas, steam, or heat sterilization techniques. Severe damage will result. Avoidable transducer damage is not covered by the warranty or service contract.

Do not bend the flexible shaft into a circle with a diameter of less than 0.30 m (1 ft).

Do not use bleach on the transducer and flexible shaft.

Do not use isopropyl alcohol-based products on any part of a TEE transducer except the connector housing and the handle.

Do not soak the transducer for extended periods of time. Limit the time that transducers are soaked in disinfectant solution to the minimum time recommended by the disinfectant manufacturer.

Do not rinse or immerse the handle, cable, connector, or the portion of the cable near the connector.

Do not immerse or rinse the steering mechanism and handle.

Follow the recommendations of the disinfectant manufacturer.

The transducer steering mechanism is unsealed. If disinfectant or other fluid enters the steering mechanism, it corrodes the gears and electrical connections. Avoidable transducer damage is not covered by the warranty or service contract.

Minimizing the Effects of Residual Disinfectant

If you use an OPA-based disinfectant, residual solution may remain on your transducers if you do not carefully follow the manufacturer’s instructions.

WARNINGS

Residual OPA on TEE transducers may cause temporary staining of the mouth and lip area and irritation or chemical burns of the mouth, throat, esophagus, and stomach.

To minimize the effects from residual OPA, or any other disinfectant, Philips recommends the following:

Follow the disinfectant manufacturer’s instructions very carefully. For example, the manufacturer of Cidex OPA recommends soaking transducers three times in fresh water.

Use a protective transducer cover during endocavity and TEE studies.

Use a sterile protective transducer cover with sterile ultrasound transmission gel during intraoperative and biopsy studies.

Limit the time that transducers are soaked in the disinfectant solution to the minimum time recommended by the disinfectant manufacturer (for example, the manufacturer of Cidex OPA recommends a minimum of 12 minutes).
High-Level Disinfection of TEE Transducers
High-Level Disinfection of TEE Transducers

High-level disinfection by immersion is the accepted method of infection control for transesophageal transducers. Philips recommends that a protective transducer cover be used during studies.

This procedure covers cleaning and disinfecting the various parts of the transducer. Different solutions may be used on different parts. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions.

Before performing this procedure, read Warnings and Cautions, Transducer Care and Operator Safety, and Warnings and Cautions for TEE Transducer Care.

Cleaning and Disinfecting TEE Transducers

1. Disconnect the transducer from the system, and remove any accessories attached to or covering the transducer.

2. Clean the transducer distal tip and flexible shaft using any of the following: enzymatic cleaner, mild soap solution, or an approved wipe. Follow the manufacturer's instructions for use. Do not use iodine-based soaps.

3. Use water to gently rinse the distal tip and flexible shaft thoroughly. Do not rinse or immerse the handle, steering mechanism, cable, or connector.

4. Choose a high-level disinfection solution compatible with your transducer. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions. Follow the label instructions for preparation and solution strength. If a pre-mixed solution is used, be sure to observe the solution expiration date.

5. Disinfect the distal tip and flexible shaft by placing them into the appropriate disinfectant as shown in the illustration. Follow the instructions on the disinfectant label for the duration of transducer immersion. Do not immerse transducers longer than the minimum time needed for your level of disinfection

6. Remove the distal tip and flexible shaft from the disinfectant and thoroughly rinse with water according to the instructions from the disinfectant manufacturer.

7. Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again.

8. Gently dry the distal tip and flexible shaft with a sterile cloth or pad, or allow it to air dry.

9. Lightly wipe only the steering mechanism and handle with a pad moistened with rubbing alcohol (70% isopropyl alcohol), or use approved cleaners as directed on the handle and steering mechanism.

10. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean the cable, the strain reliefs, and the connector. A soft-bristled brush can be used to clean only the metal surfaces of the connector.

11. Choose the disinfection solution compatible with your cable and connector. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions. Follow the label instructions for preparation and solution strength. If a pre-mixed solution is used, be sure to observe the solution expiration date.

12. Wipe or spray the cable, strain relief, and connector with the disinfectant, following disinfectant label instructions for wipe durations, solution strengths, and duration of disinfectant contact with the cable. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. Ensure that the disinfectant solution does not enter the device.

13. Hang the transducer on a wall-mounted rack, and let it air dry.

14. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or sharp edges or projections. If damage is evident, discontinue use of the transducer and contact your Philips representative.
Disinfecting TEE Transducers with an AER
Disinfecting TEE Transducers with an AER
Before performing this procedure, read Warnings and Cautions, Transducer Care and Operator Safety, and Warnings and Cautions for TEE Transducer Care.

The automated endoscopy reprocessor (AER) disinfector can be used only with those transducers listed that are listed as compatible in Compatibility Tables. Methods for disinfecting transesophageal (TEE) and non-TEE transducers differ. For non-TEE transducers, see Disinfecting Non-TEE Transducers by Immersion.

Disconnect the transducer from the system.

Follow the manufacturers' instructions for disinfection. For TEE transducers, ensure that the AER system isolates the transducer handle, cable and connector from contact with fluids used during the disinfectant cycle.  These components are unsealed, resulting in potential damage to the transducer. Avoidable transducer damage is not covered by the warranty or service contract.
Sterilization of TEE Transducers
Sterilization of TEE Transducers
Sterilization is required if the transducer enters otherwise sterile tissue without a sterile cover. If you use a sterile cover, you should sterilize, but high-level disinfection is acceptable. For information about disinfecting a transducer, see High-Level Disinfection of TEE Transducers.

The main difference between sterilization and disinfection by immersion is the length of time the transducer is immersed. To determine if your transducer requires sterilization or high-level disinfection, see Choosing the Correct Transducer Care Method.

This procedure covers cleaning and disinfecting/sterilizing the various parts of the transducer. Different solutions are used on different parts. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions.

Before performing this procedure, read Warnings and Cautions, Transducer Care and Operator Safety, and Warnings and Cautions for TEE Transducer Care.

WARNINGS

Always use protective eyewear and gloves when cleaning, disinfecting, or sterilizing any equipment.

In intraoperative applications, sterilized transducers should be used with sterile gel and a sterile transducer cover.

Sterile transducer covers are disposable and must not be reused.

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

Use only liquid solutions to sterilize transducers. Using autoclave, gas (EtO), or other methods not approved by Philips will damage your transducer and void your warranty.

Do not allow sharp objects, such as scalpels and cauterizing knives, to touch transducers or cables.

When handling a transducer, do not bump the transducer on hard surfaces.

Ensure that the solution strength and duration of contact are appropriate for sterilization. Be sure to follow the manufacturer’s instructions.

Cleaning and Sterilizing TEE Transducers

1. Disconnect the transducer from the system, and remove any accessories attached to or covering the transducer.

2. Clean the transducer distal tip and flexible shaft using any of the following: enzymatic cleaner, mild soap solution, or an approved wipe. Follow the manufacturer's instructions for use. Do not use iodine-based soaps.

3. Use water to gently rinse the distal tip and flexible shaft thoroughly. Do not rinse or immerse the handle, steering mechanism, cable, or connector.

4. Choose a sterilization solution compatible with your transducer. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions. Follow the label instructions for preparation and solution strength. If a pre-mixed solution is used, be sure to observe the solution expiration date.

5. Disinfect the distal tip and flexible shaft by placing them into the appropriate sterilization solution as shown in the illustration. Follow the instructions on the solution label for the duration of transducer immersion. Do not immerse transducers longer than the minimum time needed for your level of sterilization.

6. Remove the distal tip and flexible shaft from the sterilization solution and thoroughly rinse with water according to the instructions from the solution manufacturer.

7. Check the transducer for any residual organic material. If any is present, remove it and sterilize the transducer again.

8. Gently dry the distal tip and flexible shaft with a sterile cloth or pad, or allow it to air dry.

9. Lightly wipe only the steering mechanism and handle with a pad moistened with rubbing alcohol (70% isopropyl alcohol), or use approved cleaners as directed on the handle and steering mechanism.

10. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean the cable, the strain reliefs, and the connector. A soft-bristled brush can be used to clean only the metal surfaces of the connector.

11. Choose the disinfection solution compatible with your cable and connector. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions. Follow the label instructions for preparation and solution strength. If a pre-mixed solution is used, be sure to observe the solution expiration date.

12. Wipe or spray the cable, strain relief, and connector with the disinfectant, following disinfectant label instructions for wipe durations, solution strengths, and duration of disinfectant contact with the cable. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. Ensure that the disinfectant solution does not enter the device or the connector.

13. Hang the transducer on a wall-mounted rack, and let it air dry.

14. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or sharp edges or projections. If damage is evident, discontinue use of the transducer and contact your Philips representative

Transducer and System Care

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Cleaning, Disinfecting, and Sterilizing TEE Transducers

Warnings and Cautions for TEE Transducer Care

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