philips_transducer_and_system_care_and_cleaning_gui.pdf
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Transducer and System Care and Cleaning
4535 617 39631
Rev A
November 2013
© 2013 Koninklijke Philips N.V. All rights reserved. Published in USA.
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Philips Ultrasound
22100 Bothell-Everett Highway
Bothell, WA 98021-8431
USA
Telephone: +1 425-487-7000 or 800-426-2670
Fax: +1 425-485-6080
www.healthcare.philips.com/ultrasound
This document and the information contained in it is proprietary and confidential information of Philips Healthcare ("Philips") and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Philips
Legal Department. This document is intended to be used either by customers and is licensed to them as part of their Philips equipment purchase
or to meet regulatory commitments as required by the FDA under 21 CFR 1020.30 (and any amendments to it) and other local regulatory requirements. Use of this document by unauthorized persons is strictly prohibited.
Philips provides this document without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.
Philips has taken care to ensure the accuracy of this document. However, Philips assumes no liability for errors or omissions and reserves the right
to make changes without further notice to any products herein to improve reliability, function, or design. Philips may make improvements or
changes in the products or programs described in this document at any time.
Unauthorized copying of this document, in addition to infringing copyright, might reduce the ability of Philips to provide accurate and current information to users.
This product may contain remanufactured parts equivalent to new in performance, or parts that have had incidental use.
Philips Healthcare
Non-Philips product names may be trademarks of their respective owners.
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Contents
Contents
Philips Healthcare
Transducer Care Overview ........................................................................................................................ 5
Choosing the Correct Transducer Care Method ......................................................................................... 6
Warnings and Cautions ................................................................................................................................. 7
Transducer Care and Operator Safety ...................................................................................................... 10
Latex Product Alert ..................................................................................................................................... 10
Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers .................................................................... 15
Cleaning Non-TEE Transducers, Cables, and Connectors ............................................................................ 16
Cleaning and Disinfecting Cables and Connectors ...................................................................................... 18
Low-Level Disinfection of Non-TEE Transducers ......................................................................................... 19
High-level Disinfection of Non-TEE Transducers ......................................................................................... 20
Sterilization of Non-TEE Transducers .......................................................................................................... 23
Cleaning, Disinfecting, and Sterilizing TEE Transducers ............................................................................ 25
Warnings and Cautions for TEE Transducer Care ........................................................................................ 26
High-Level Disinfection of TEE Transducers ................................................................................................ 28
Disinfecting TEE Transducers with an AER .................................................................................................. 30
Sterilization of TEE Transducers .................................................................................................................. 31
Disinfectants .......................................................................................................................................... 34
About Disinfectants .................................................................................................................................... 34
Choosing Disinfectants and Cleaning Solutions .......................................................................................... 35
Related Care Information ........................................................................................................................ 37
System Maintenance .................................................................................................................................. 37
Ultrasound Transmission Gels .................................................................................................................... 43
Transducer Storage and Transport .............................................................................................................. 44
Supplies, Accessories, and Customer Service ............................................................................................. 45
Transducer and System Care and Cleaning
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Philips Healthcare
Contents
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Transducer and System Care and Cleaning 4535 617 39631
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Transducer Care Overview
Transducer Care Overview
Transducers require proper care, cleaning, and handling. These pages contain information and instructions
to help you effectively clean, disinfect, and sterilize the transducers that are compatible with your Philips
ultrasound system. Additionally, these instructions help avoid damage during cleaning, disinfection, and
sterilization, which could void your warranty.
Reasonable care includes inspection, cleaning, and disinfection or sterilization, as necessary. Transducers
must be cleaned after each use. Inspect all parts of the transducer carefully before each use. Check for
cracks or other damage that jeopardizes the integrity of the transducer. Report any damage to your Philips
representative, and discontinue use of the transducer. For more information, see your system User
Manual, which contains information that is specific to your system and transducers.
The following topics explain how to clean and disinfect your Philips Ultrasound transducers and systems.
Care and Cleaning Topics
0
Disinfectants
Related Care Information
• “Choosing the Correct Transducer
Care Method” on page 6
• “Transducer Care and Operator
Safety” on page 10
• “Cleaning, Disinfecting, and Sterilizing
Non-TEE Transducers” on page 15
• “Cleaning, Disinfecting, and Sterilizing
TEE Transducers” on page 25
• “About Disinfectants” on page 34
• “Choosing Disinfectants and Cleaning
Solutions” on page 35
• “System Maintenance” on page 37
• “Ultrasound Transmission Gels” on
page 43
• “Transducer Storage and Transport”
on page 44
• “Supplies, Accessories, and
Customer Service” on page 45
Philips Healthcare
Cleaning and Disinfecting Transducers
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Choosing the Correct Transducer Care Method
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 (see table). The care method for your transducer determines the
appropriate disinfectant for your transducer. For details about compatible disinfectants, see
“Disinfectants” on page 34. 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.
Cleaning Methods
0
Non-TEE Transducer Use
Example
Classification
Care Method
Contacts intact skin
Curved, linear, xMatrix,
and sector transducers
Noncritical
“Low-Level Disinfection of Non-TEE Transducers”
on page 19
Contacts mucous
membranes
Endocavity
Semi-critical
“High-level Disinfection of Non-TEE Transducers”
on page 20
Enters otherwise sterile
tissue
Intraoperative and
laparoscopic
Critical
“High-level Disinfection of Non-TEE Transducers”
on page 20 1
OR
“Sterilization of Non-TEE Transducers” on page 23
TEE Transducer Use
Example
Classification
Care Method
Contacts mucous
membranes
Transesophageal (TEE)
Critical
“High-Level Disinfection of TEE Transducers” on
page 281
OR
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:
www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070911.pdf.
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“Sterilization of TEE Transducers” on page 31
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Choosing the Correct Transducer Care Method
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.
Philips Healthcare
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.
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Choosing the Correct Transducer Care Method
CAUTIONS
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.
Philips Healthcare
•
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Choosing the Correct Transducer Care Method
Identifies the parts of the transducer
that can be cleaned with alcohol
- Non-TEE transducer -
- TEE transducer 0
Philips Healthcare
Alcohol-Compatible Parts of Transducers
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Transducer Care and Operator Safety
Transducer Care and Operator Safety
Observe the following warnings when using disinfectants. More specific warnings and cautions are
included within the care and cleaning procedures and on the labels of the cleaning or disinfection
solutions.
WARNINGS
•
Disinfectants are recommended because of their chemical compatibility with product materials, not
their biological effectiveness. For the biological effectiveness of a disinfectant, see the guidelines
and recommendations of the disinfectant manufacturer, the U.S. Food and Drug Administration,
and the U.S. Centers for Disease Control.
•
The level of disinfection required for a device is dictated by the type of tissue it will contact during
use and the type of transducer being used. Ensure that the disinfectant type is appropriate for the
type of transducer and the transducer application. For information on the levels of disinfection
requirements, see “Choosing the Correct Transducer Care Method” on page 6. Also, see the
disinfectant label instructions and the recommendations of the Association for Professionals in
Infection Control, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.
•
Sterile transducer covers with sterile ultrasound transmission gel are required for intraoperative
and biopsy procedures. Protective covers are recommended for transrectal and intravaginal
procedures; in China and Japan, the covers are mandatory. Philips recommends the use of qualified
covers.
•
In intraoperative applications (other than TEE or endoscopy), transducers used with sterile gel and
sterile transducer covers may use either the high-level disinfection or sterilization care method.
•
Bite guards are mandatory for TEE transducers.
Latex Product Alert
Philips ultrasound systems and transducers do not contain natural rubber latex that contacts humans.
Natural rubber latex is not used on any ultrasound transducer, including transthoracic, intraoperative, and
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For information on ordering transducer covers, bite guards, and other supplies, contact CIVCO Medical
Solutions (see “Supplies and Accessories” on page 45 and “Customer Service” on page 45).
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Transducer Care and Operator Safety
transesophageal echocardiography (TEE) transducers. It also is not used on Philips ECG cables for
ultrasound products.
WARNINGS
•
Transducer covers can contain natural rubber latex, which may cause allergic reactions in some
individuals.
•
The M2203A bite guard strap contains natural rubber latex, which may cause allergic reactions.
FDA Medical Alert on Latex
March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices
Because of reports of severe allergic reactions to medical devices containing latex (natural rubber), the
FDA is advising health care professionals to identify their latex sensitive patients and be prepared to treat
allergic reactions promptly. Patient reactions to latex have ranged from contact urticaria to systemic
anaphylaxis. Latex is a component of many medical devices, including surgical and examination gloves,
catheters, intubation tubes, anesthesia masks, and dental dams.
Reports to the FDA of allergic reactions to latex-containing medical devices have increased lately. One
brand of latex cuffed enema tips was recently recalled after several patients died as a result of
anaphylactoid reactions during barium enema procedures. More reports of latex sensitivity have also
been found in the medical literature. Repeated exposure to latex both in medical devices and in other
consumer products may be part of the reason that the prevalence of latex sensitivity appears to be
increasing. For example, it has been reported that 6% to 7% of surgical personnel and 18% to 40% of spina
bifida patients are latex sensitive.
Philips Healthcare
Proteins in the latex itself appear to be the primary source of the allergic reactions. Although it is not now
known how much protein is likely to cause severe reactions, the FDA is working with manufacturers of
latex-containing medical devices to make protein levels in their products as low as possible.
FDA’s recommendations to health professionals in regard to this problem are as follows:
•
When taking general histories of patients, include questions about latex sensitivity. For surgical and
radiology patients, spina bifida patients and health care workers, this recommendation is especially
important. Questions about itching, rash or wheezing after wearing latex gloves or inflating a toy
balloon may be useful. Patients with positive histories should have their charts flagged.
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Transducer Care and Operator Safety
•
If latex sensitivity is suspected, consider using devices made with alternative materials, such as plastic.
For example, a health professional could wear a non-latex glove over the latex glove if the patient is
sensitive. If both the health professional and the patient are sensitive, a latex middle glove could be
used. (Latex gloves labeled “Hypoallergenic” may not always prevent adverse reactions.)
•
Whenever latex-containing medical devices are used, especially when the latex comes in contact with
mucous membranes, be alert to the possibility of an allergic reaction.
•
If an allergic reaction does occur and latex is suspected, advise the patient of a possible latex
sensitivity and consider an immunologic evaluation.
•
Advise the patient to tell health professionals and emergency personnel about any known latex
sensitivity before undergoing medical procedures. Consider advising patients with severe latex
sensitivity to wear a medical identification bracelet.
The FDA is asking health professionals to report incidents of adverse reactions to latex or other materials
used in medical devices. (See the October 1990 FDA Drug Bulletin.) To report an incident, contact the FDA
Problem Reporting Program, MedWatch, at 1-800-332-1088, or on the Internet:
www.fda.gov/Safety/MedWatch/
For a single copy of a reference list on latex sensitivity, write to: LATEX, FDA, HFZ-220, Rockville, MD 20857.
Transmissible Spongiform Encephalopathy
Infection Control
Issues related to infection control affect the operator and the patient. Follow the infection control
procedures established in your facility for the protection of both the staff and the patients.
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WARNING
If a sterile transducer cover becomes compromised during an intraoperative application involving a
patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob disease, follow the
guidelines of the U.S. Centers for Disease Control and this document from the World Health Organization:
WHO/CDS/ APH/2000/3, WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies. The transducers for your system cannot be decontaminated using a heat process.
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Transducer Care and Operator Safety
Handling Contaminated Transducers
The primary area of concern is the handling of transducers that have contacted infected patients. Always
wear gloves when you handle transducers used in TEE, endocavity, intraoperative, and biopsy procedures
that have not been previously disinfected.
For information on cleaning and disinfecting transducers, see “Transducer Care Overview” on page 5.
Removing Blood and Infectious Material from the System
CAUTION
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.
Use a gauze pad moistened with soap and water to remove blood on the system and the transducer
connectors and cables. Then dry the equipment with a soft cloth to prevent corrosion. You can use a 70%
solution of isopropyl alcohol on the system and on limited parts of some transducers as noted above.
Philips Healthcare
Additional cleaning agents are available for transducers. For more information, see “Transducer Care
Overview” on page 5. For more information about removing blood and other infectious material from the
system, see “Disinfecting System Surfaces” on page 40.
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Transducer Care and Operator Safety
Disposable Drape
If you believe contamination of the system might occur during an exam, Philips recommends that you take
universal precautions and cover the system with a disposable drape. Consult your facility's rules regarding
equipment use in the presence of infectious disease.
CAUTION
Position the disposable drape so that it does not block the vents on the system, the monitors, or the
peripherals.
Transducer Covers
To prevent contamination by blood-borne pathogens, sterile transducer covers are required for
intraoperative and biopsy procedures; in China, sterile covers are also required for transrectal,
intravaginal, and transesophageal procedures. Protective covers are recommended for transrectal,
intravaginal, and transesophageal procedures; the protective covers are mandatory in China and Japan.
Philips recommends the use of qualified covers. For procedures for using transducer covers, see the
instructions provided with the covers.
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•
Latex and talc are commonly used in transducer covers marketed to help with infection control in
transesophageal, endocavity, and intraoperative imaging applications and during biopsies. Examine
the packaging to confirm latex and talc content. Studies have shown that patients can experience
allergic reactions with natural rubber latex. See the FDA Medical Alert, March 29, 1991, reprinted in
“FDA Medical Alert on Latex” on page 11.
•
In intraoperative applications, sterilized transducers should be used with sterile gel and a sterile
transducer cover.
•
Do not apply the transducer cover until you are ready to perform the procedure.
•
Inspect transducer covers before and after use.
•
If the sterile transducer cover becomes compromised during an intraoperative application involving
a patient with Creutzfeldt-Jakob disease, follow the recommendations described in “Transmissible
Spongiform Encephalopathy” on page 12.
Transducer and System Care and Cleaning 4535 617 39631
Philips Healthcare
WARNINGS
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
WARNINGS
•
Transducer covers are disposable and must not be reused.
•
If an installed transducer cover is cut or contaminated before use, the probe should be cleaned and
disinfected or sterilized, and a new sterile cover installed.
Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
The following topics explain how to clean, disinfect, and sterilize non-TEE transducers. To determine the
appropriate care method for your transducer, see “Choosing the Correct Transducer Care Method” on
page 6.
For TEE transducer care instructions, see “Cleaning, Disinfecting, and Sterilizing TEE Transducers” on page
25.
Philips Healthcare
All transducers must be cleaned after each use. Cleaning the transducer is an essential step before
effective disinfection or sterilization. The following figure identifies the components of non-TEE
transducers.
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
Connector housing
Connector strain relief
Transducer strain relief
Cable
Transducer housing
Connector cover
(optional)
Connector electrical contacts
(under cover)
Transducer lens
Non-TEE Transducer Components
0
Cleaning Non-TEE Transducers, Cables, and Connectors
These general cleaning instructions must be followed for all non-TEE transducers, cables, and connectors.
Before cleaning a transducer, read “Warnings and Cautions” on page 7 and “Transducer Care and
Operator Safety” on page 10. After cleaning, you must disinfect or sterilize non-TEE transducers by
following the appropriate procedures: “Low-Level Disinfection of Non-TEE Transducers” on page 19,
“High-level Disinfection of Non-TEE Transducers” on page 20, or “Sterilization of Non-TEE Transducers” on
page 23.
2. Disconnect the transducer from the system, and remove any accessories attached to or covering the
transducer. Push the connector cover, if available, onto the connector to protect against fluid splashing
onto the contacts.
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1. After every patient study, use a moist cloth to remove the ultrasound transmission gel from the
transducer.
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
3. Use a soft cloth lightly dampened in a mild soap or an enzymatic cleaner (in accordance with the
manufacturer's instructions) to remove any particulate matter or body fluids that remain on the
transducer, cable, or connector. Enzymatic cleaners are generically approved for use.
4. When cleaning the connector, do not allow any type of fluid to enter through the strain relief,
electrical contacts, or areas surrounding the locking-lever shaft and the strain relief. You may use a
soft-bristled brush to clean only the metal surfaces of the connector.
5. When cleaning the lens, use a blotting motion rather than a wiping motion.
6. To remove remaining particulate and cleaning residue, use cleaning wipes according to the
manufacturers’ instructions, or rinse thoroughly with water up to the immersion point shown below.
Do not immerse the connector, connector strain relief, or cable that is within 5 cm (2 in) of the strain
relief.
Do not immerse beyond
this point, 5 cm (2 in)
from the strain relief
Immersion Point for Non-TEE Transducers
0
NOTE
If you use cleaning wipes, it may be unnecessary to rinse the transducer with water. Always follow the
product label recommendations.
Philips Healthcare
7. If necessary, wipe the transducer with a dry cloth. To dry the lens, use a soft cloth and a blotting
motion instead of a wiping motion.
8. Examine the device and cable for damage such as cracks, splitting, sharp edges, or projections. If
damage is evident, discontinue use of the device and contact your Philips representative.
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
Cleaning and Disinfecting Cables and Connectors
Use this procedure when you need to clean only cables or connectors for any type of transducer. You can
disinfect the cables and connectors of all transducers with a wipe or spray disinfectant recommended for
your transducer.
Before cleaning and disinfecting cables and connectors, read “Warnings and Cautions” on page 7 and
“Transducer Care and Operator Safety” on page 10.
CAUTION
Do not bend or crimp the gastroscope (flexible shaft) or cable.
1. Disconnect the device from the system, and remove any accessories attached to or covering the
transducer. Push the connector cover, if available, onto the connector to protect against fluid splashing
onto the contacts.
2. 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.
3. Choose the disinfection solution compatible with your cable and connector. For a list of compatible
disinfectants, see the Web site for your Philips Ultrasound system. Follow the label instructions for
preparation and solution strength. If a pre-mixed solution is used, be sure to observe the solution
expiration date.
Philips Healthcare
4. 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.
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
Identifies the parts to wipe or spray
Connector strain relief
Connector
Cable
Transducer strain relief
Disinfecting the Cable, Strain Reliefs, and Connector
0
5. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label.
6.
Examine the device and cable for damage such as cracks, splitting, sharp edges, or projections. If
damage is evident, discontinue use of the device and contact your Philips representative.
Low-Level Disinfection of Non-TEE Transducers
Low-level disinfection of non-TEE transducers uses the spray or wipe method, with a low- or intermediate
level disinfectant. Before disinfecting a transducer, read “Warnings and Cautions” on page 7 and
“Transducer Care and Operator Safety” on page 10.
Philips Healthcare
NOTE
Transducers can be disinfected using the wipe method only if the product labeling of the compatible
disinfectant you are using indicates it can be used with a wipe method.
1. Clean the transducer according to the procedures in “Cleaning Non-TEE Transducers, Cables, and
Connectors” on page 16. Observe all warnings and cautions.
2. After cleaning, choose a low- or intermediate-level disinfection solution compatible with your
transducer, cable, and connector. Follow the label instructions for preparation and solution strength. If
a pre-mixed solution is used, be sure to observe the solution expiration date. For information on the
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
disinfectants compatible with non-TEE transducers, see the Philips Ultrasound Transducer Care
website (www.healthcare.philips.com/us/products/ultrasound/transducers/transducer_care/).
3. Wipe or spray the transducer, cable, strain relief, and connector with the disinfectant, following
disinfectant label instructions for wipe durations and duration of disinfectant contact. 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.
4. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label.
5. Examine the device and cable for damage such as cracks, splitting, sharp edges, or projections. If
damage is evident, discontinue use of the device and contact your Philips representative.
High-level Disinfection of Non-TEE Transducers
High-level disinfection of non-TEE transducers uses the immersion method. Before disinfecting a
transducer, read “Warnings and Cautions” on page 7 and “Transducer Care and Operator Safety” on page
10.
WARNING
If a pre-mixed disinfectant is used, be sure to observe the expiration date.
20
•
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
•
Using non-recommended disinfectants, using incorrect solution strengths, or immersing a
transducer deeper or longer than recommended can damage or discolor the transducer and voids
the transducer warranty.
•
Do not immerse transducers longer than the minimum time needed for your level of disinfection.
For information on the levels of disinfection requirements, see “Choosing the Correct Transducer
Care Method” on page 6.
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Philips Healthcare
CAUTIONS
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
Isopropyl Alcohol Restrictions
CAUTION
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.
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.
WARNING
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.
Philips Healthcare
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).
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
Disinfecting Non-TEE Transducers by Immersion
1. Clean the transducer according to the procedures in “Cleaning Non-TEE Transducers, Cables, and
Connectors” on page 16. Observe all warnings and cautions.
2. After cleaning, choose a high-level disinfection solution compatible with your transducer. Follow the
label instructions for preparation and solution strength. If a pre-mixed solution is used, be sure to
observe the solution expiration date. For information on disinfectant compatibility, see the Philips
Ultrasound Transducer Care website (www.healthcare.philips.com/us/products/ultrasound/
transducers/transducer_care/).
3. Immerse the transducer into the appropriate disinfectant for your transducer as shown in the
illustration. Do not immerse the connector, connector strain relief, or cable that is within 5 cm (2 in) of
the strain relief.
Do not immerse beyond
this point, 5 cm (2 in)
from the strain relief
Immersion Point for Non-TEE Transducers
0
4. 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. Using an appropriate disinfectant for the cable and connector, wipe or spray the cable, strain relief,
and connector, following disinfectant label instructions for wipe durations, solution strengths, and
duration of disinfectant contact. 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.
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5. Using the instructions on the disinfectant label, rinse the transducer up to the point of immersion. Do
not immerse the connector, connector strain relief, or cable that is within 5 cm (2 in) of the strain
relief.
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
7. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label.
8. 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.
Sterilization of Non-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 you can disinfect (high-level disinfection). The main difference
between sterilization and disinfection by immersion is the length of time the transducer is immersed. For
information about disinfecting a non-TEE transducer, see “High-level Disinfection of Non-TEE Transducers”
on page 20.
To determine if your transducer requires sterilization or high-level disinfection, see “Choosing
Disinfectants and Cleaning Solutions” on page 35.
Before sterilizing a transducer, read “Warnings and Cautions” on page 7 and “Transducer Care and
Operator Safety” on page 10.
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.
Philips Healthcare
•
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Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers
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.
Sterilizing Non-TEE Transducers by Immersion
1. Clean the transducer and cable according to the procedures in “Cleaning Non-TEE Transducers, Cables,
and Connectors” on page 16. Observe all warnings and cautions.
2. After cleaning, choose a sterilization solution that is compatible with your transducer, cable, and
connector. Follow the label instructions for preparation and solution strength. If a pre-mixed solution
is used, be sure to observe the solution expiration date. For information on the disinfectants that are
compatible with non-TEE transducers, see the Philips Ultrasound Transducer Care website
(www.healthcare.philips.com/us/products/ultrasound/transducers/transducer_care/).
3. Immerse the transducer in the sterilization solution as shown in the illustration. Do not immerse the
connector, connector strain relief, or cable within 5 cm (2 in) of the strain relief.
Immersion Point of Non-TEE Transducers
0
4. Follow the instructions on the sterilization label for the duration of transducer immersion required for
sterilization.
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Philips Healthcare
Do not immerse beyond
this point, 5 cm (2 in)
from the strain relief
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Cleaning, Disinfecting, and Sterilizing TEE Transducers
5. Remove the transducer from the sterilization solution after the recommended sterilization time has
elapsed.
6. Using the instructions on the sterilization label, rinse the transducer in sterile water up to the point of
immersion. Do not immerse the connector, connector strain relief, or cable that is within 5 cm (2 in) of
the strain relief.
7. Using an appropriate disinfectant for the cable and connector, wipe or spray the cable, strain relief,
and connector, following disinfectant label instructions for wipe durations, solution strengths, and
duration of disinfectant contact. 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.
8. Air dry or towel dry with a sterile cloth according to the instructions on the sterilization solution label.
9. 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.
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” on
page 6.
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.
Philips Healthcare
For non-TEE transducer care instructions, see “Cleaning, Disinfecting, and Sterilizing Non-TEE Transducers”
on page 15. The following figure identifies the components of a TEE Transducer.
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