This information is effective as of May 2003.
| General Cleaning for Transducers Used in Noninvasive Procedures |
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These general cleaning instructions are indicated for non-critical category transducers. All transducers that do not contact mucus membranes, blood, or compromised tissue, and are not used in sterile fields can be cleaned by using these instructions. It is important that you clean the transducer and cable according to the following procedures.
To clean transducers used in noninvasive procedures:
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After every patient exam, wipe the ultrasound transmission gel off of the transducer.
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Wipe the transducer and cable with a dry or water-moistened soft cloth.
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Wipe the transducer with either:
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A 10% bleach solution
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Isopropyl alcohol (70%)
CAUTION: The use of 70% isopropyl alcohol (rubbing alcohol) on transducers is restricted. You may wipe only the distal tip of the transducer up to one inch (2.5 cm) from the strain relief/housing joint with an isopropyl alcohol solution.
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You can also wipe the cable with a glutaraldehyde-based disinfectant, T-sprayTM, or a 10% bleach solution. Do not use isopropyl alcohol on the cable.
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Additionally, you can also wipe the following transducers, including the cables, with a low-level disinfectant for the cleaning of external transducers only. You can use T-Spray on the following transducers:
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Model 21311A (s3)
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Model 21315A (x4)
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Model 21330A (s4)
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Model 21350A (s8)
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Model 21356A (11-3L)
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Model 21380A (S12)
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Model 21422A (PA 4-2)
You can use T-Spray IITM on the following transducers:
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Remove any residue with a soft cloth moistened in water. Do not allow cleaning solutions or isopropyl alcohol to air-dry on the transducer.
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| Cleaning and Disinfecting Transducers Used in Endocavity Procedures |
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High-level disinfection is the accepted method of infection control for transducers used in endocavity procedures. Use of a protective sheath during the exam is also recommended. Use this disinfection method for the following transducers:
- Model 21336A (E6509)
- Model 21370A (E6514)
- Model 21371A (E7511)
- Model 989803002241 (C8-4v)
Upon receiving your new transducer, disinfect it before performing the first exam. Clean and disinfect the transducer immediately after each use to protect patients and personnel from a variety of pathogens. Establish and clearly post a disinfectant procedure that includes the following steps.
To clean and high-level disinfect transducers used in endocavity procedures:
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Unplug the transducer from the system.
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Wash the transducer head and the first 50 cm of the cable with soap and water to remove any protein buildup; however, do not rinse or immerse connector or the portion of the cable near the connector. To assist in removing protein residuals, Philips recommends using an enzymatic cleaner. A common enzymatic cleaner is one with a pH of 6.0 to 8.0 (for example, MetriZyme) that contains diluted concentrations of surfacants, alcohols, salts, and acids. These cleaners are further diluted during use.
NOTE: Follow the recommendations of the enzymatic cleaner manufacturer.
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Do not use strong solvents such as acetone, freon, and other industrial cleaners on transducers.
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Limit the time that probes are soaked in disinfectant solution to the minimum time recommended by the disinfectant manufacturer.
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Do not rinse or immerse the connector or the portion of the cable near the connector.
NOTE: Follow the recommendations of the disinfectant manufacturer.
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Remove the transducer from the disinfectant and thoroughly rinse with water according to the instructions for use from the disinfectant manufacturer.
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Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again.
CAUTION: Never sterilize the transducer with autoclave, ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques. Severe damage will result. Avoidable transducer damage is not covered by the warranty or service contract.
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| Cleaning and Disinfecting TEE Transducers |
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High-level disinfection is the accepted method of infection control for TEE transducers. It is recommended that a protective sheath be used during examinations.
Use this disinfection method for the following transducers:
- Model 21364A (OmniPlane)
- Model 21366A (Pedi BiPlane)
- Model 21367A (OmniPlane II)
- Model 21369A (OmniPlane II)
- Model 21378A (OmniPlane III)
- Model 21381A (miniMultiplane)
Upon receiving your new transducer, disinfect it before performing the first exam. Clean and disinfect the transducer immediately after each use to protect patients and personnel from a variety of pathogens. Establish and clearly post a disinfectant procedure that includes the following steps.
To clean and high-level disinfect a TEE transducer:
- Disconnect the transducer from the system.
- Use the following procedure to remove all organic matter and other residue:
- Soak gauze pads in mild, soapy water. Do not use iodine-based soaps.
- Wipe the distal tip and flexible shaft up to the control housing (steering mechanism) with the gauze pads.
Philips recommends using an enzymatic cleaner to assist in removing protein residuals. A common enzymatic cleaner is one with a pH of 6.0 to 8.0 (for example, MetriZyme) that contains diluted concentrations of surfacants, alcohols, salts, and acids. These cleaners are further diluted during use.
NOTE: Follow the recommendations of the enzymatic cleaner manufacturer.
- Rinse the distal tip and flexible shaft thoroughly using water.
CAUTION: Do not rinse or immerse the control housing, cable, or connector. For the Model 21381A, miniMultiplane, do not immerse past the 65cm marker.
- Disinfect the distal tip and flexible shaft by placing them in one of the glutaraldehyde-based disinfectants or the non-glutaraldehyde-based disinfectants listed on the Disinfectants page.
- Do not bend the shaft into a circle with a diameter of less than one foot (30 cm).
- Do not use bleach on any TEE transducer.
- Do not use strong solvents such as acetone, freon, and other industrial cleaners on transducer.
- Do not soak the transducer for extended periods of time, such as overnight.
- Do not rinse or immerse the connector or the portion of the cable near the connector.
- Do not immerse or rinse the steering mechanism.
- Limit the time that probes are soaked in disinfectant solution to the minimum time recommended by the disinfectant manufacturer.
NOTE: Follow the recommendations of the disinfectant manufacturer.
- Remove the tip and shaft from the disinfectant and thoroughly rinse with water according to the instructions for use from the disinfectant manufacturer.
- Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again.
- Dry the distal tip and flexible shaft with a soft cloth or pad.
- Lightly wipe the handle and steering mechanism with a pad moistened with rubbing alcohol (70% isopropyl alcohol).
- Hang the transducer on a wall-mounted rack and let it air dry.
CAUTION: The transducer steering mechanism is not sealed. If disinfectant or other fluid enters the steering mechanism, it will corrode the gears and electrical connections. Avoidable transducer damage is not covered by the warranty or service contract.
CAUTION: Never sterilize the transducer with autoclave, ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques. Severe damage will result. Avoidable transducer damage is not covered by the warranty or service contract.
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| Cleaning and Disinfecting Transducers Used in Biopsy Procedures |
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High-level disinfection and the use of a sterile sheath is the accepted method of infection control for this critical category of device.
Use this disinfection method for the following transducers when used for biopsies:
Refer to one of the following sections to clean a biopsy-capable transducer when it is used in the following procedures:
To clean and high-level disinfect transducers used in biopsy procedures:
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Unplug the transducer from the system.
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Wash the transducer head and cable with soap and water to remove any protein buildup; however, do not rinse or immerse the connector, or the portion of the cable near the connector.
To assist in removing protein residuals, Philips recommends using an enzymatic cleaner. A common enzymatic cleaner is one with a pH of 6.0 to 8.0 (for example, MetriZyme) that contains diluted concentrations of surfacants, alcohols, salts, and acids. These cleaners are further diluted during use.
NOTE: Follow the recommendations of the enzymatic cleaner manufacturer.
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Avoid transducer contact with strong solvents such as acetone, freon, and other industrial cleaners.
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Limit the time that probes are soaked in disinfectant solution to the minimum time recommended by the disinfectant manufacturer.
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Do not rinse or immerse the connector or the portion of the cable near the connector.
NOTE: Follow the recommendations of the disinfectant manufacturer.
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Remove the transducer from the disinfectant and thoroughly rinse with water according to the instructions for use from the disinfectant manufacturer.
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Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again.
CAUTION: Never sterilize the transducer with autoclave, ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques. Severe damage will result. Avoidable transducer damage is not covered by the warranty or service contract.
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| Cleaning and Disinfecting Transducers Used in Intraoperative Procedures |
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High-level disinfection and the use of a sterile sheath is the accepted method of infection control for this critical category of device.
Use the disinfection method described in this section for the following transducers:
- Model 21315A (x4)
- Model 21358B (L7540)
- Model 21380A (s12)
- Model 21390A (15-6L)
 Intraoperative probes used in animal studies should not be used on humans. Transducer disinfection procedures for cross-usage between animals and humans have not been validated. When a probe is used for animal studies, the animal use label must be attached, as described in Animal Use Label. 
To clean an intraoperative transducer when it is used in a noninvasive procedure, see General Cleaning.
To clean and high-level disinfect intraoperative transducers:
- Unplug the transducer from the system.
- Wash the transducer head and cable with soap and water to remove any protein buildup; however, do not rinse or immerse the connector or the portion of the cable the near the connector.
To assist in removing protein residuals, Philips recommends using an enzymatic cleaner. A common enzymatic cleaner is one with a pH of 6.0 to 8.0 (for example, MetriZyme) that contains diluted concentrations of surfacants, alcohols, salts, and acids. These cleaners are further diluted during use.
NOTE: Follow the recommendations of the enzymatic cleaner manufacturer.
- Disinfect the transducer and the cable with one of the glutaraldehyde-based disinfectants. For the Model 21390A (15-6L) transducer, you may use either a glutaraldehyde-based disinfectant, or Cidex OPA. See non-glutaraldehyde-based disinfectants for more information.
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Do not use solvents such as acetone, freon, and other industrial cleaners on transducers.
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Limit the time that probes are soaked in disinfectant solution to the minimum time recommended by the disinfectant manufacturer.
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Do not rinse or immerse the connector or the portion of the cable near the connector.
NOTE: Follow the recommendations of the disinfectant manufacturer.
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Remove the transducer from the disinfectant and thoroughly rinse with water according to the instructions for use from the disinfectant manufacturer.
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Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again.
CAUTION: Never sterilize the transducer with autoclave, ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques. Severe damage will result. Avoidable transducer damage is not covered by the warranty or service contract.
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If an intraoperative probe is to be used on animals, attach the label “This transducer is for use in animal or other studies that do not involve human subjects” that accompanies the transducer. To attach the label:
- Wipe the side of the connector, opposite the serial number label, with an isopropyl alcohol moistened cloth and dry with a soft cloth.
- Place the label on the transducer connector housing at the indented area (opposite the serial number label).
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