Transducer And System Care And Cleaning
Contents
1. 38 Related Care Information WARNING Always use protective eyewear and gloves when cleaning and disinfecting any equipment CAUTIONS Orient the parts that must remain dry higher than the wet parts until all parts are dry When cleaning the system control panel monitor screen touch screen and keyboard take care not to get any solution inside the housings Do not use strong solvents common cleaning products or abrasive cleansers which will damage the system surfaces Do not use cleaners containing bleach on the displays It may damage the surfaces Do not touch the displays with sharp objects or use paper towels to clean them which may damage them Take care not to scratch the face of the display while cleaning it Use the following procedure to clean these system parts Display screens including monitor and touch screens System control panel External surfaces of the system and the cart ECG trunk cables leads and electrodes Before cleaning turn off the system and unplug the power cord from the power source To clean display screens a Remove dust with a soft lint free cloth A microfiber cloth is recommended b Clean the screens with a liquid screen cleaner specifically designed for LCDs Spray the liquid onto the cleaning cloth or spray sparingly onto the displays You can also use pre moistened screen wipes c Dry the displays with a soft lint free cloth Transducer and System Care and Cleaning 45352. Transducer and System Care and Cleaning 4535 617 39631 RevB December 2013 2013 Koninklijke Philips N V All rights reserved Published in USA PHILIPS 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 re produced 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 require ments 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 mer chantability 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 impr
3. 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 WARNINGS e 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 e In intraoperative applications sterilized transducers should be used with sterile gel and a sterile transducer cover e Do not apply the transducer cover until you are ready to perform the procedure e Inspect transducer covers before and after use e Ifthe sterile transducer cover becomes compromised during an intraoperative application involving a patient with Creutzfeldt Jakob disease follow the recommendations described in Transmissible Spongiform Enceph
4. 617 39631 Related Care Information 3 To clean the control panel remove any solid matter around keys or controls with a cotton swab or toothpick to ensure that solids are not pushed into the cabinet Wipe with a soft cloth moistened with soap and water A CAUTION Do not spill or spray liquid on the controls into the system cabinet or into the transducer receptacles 4 To clean the remaining external surfaces of the system and the cart ECG trunk cables leads and electrodes wipe with a soft cloth moistened with soap and water You may use alcohol for stubborn stains or inks then wash with soap and water 5 Ifthe equipment has come in contact with blood or infectious material you can clean most surfaces with a 70 solution of isopropyl alcohol For instructions on disinfecting system surfaces see Disinfectants for System Surfaces Except Display Screens on page 39 A CAUTION If blood or other infectious material comes in contact with a transducer or transducer cable do not wipe with isopropyl alcohol until you have read specific cleaning guidelines Isopropyl alcohol use is highly restricted on transducers and should never be used on any parts of the transducer cable Additional cleaning agents are also available for transducers 6 Remove any residue with a cloth moistened with sterile water 7 Dry the equipment to prevent potential corrosion Disinfectants for System Surfaces Except Display Screens The exterior s
5. 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 Do not immerse beyond this point 5 cm 2 in from the strain relief Immersion Point of Non TEE Transducers 4 24 Follow the instructions on the sterilization label for the duration of transducer immersion required for sterilization Transducer and System Care and Cleaning 4535 617 39631 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 Air dry or towel dry with a sterile cloth according to the instructions on the sterilization solution label 9 Exam
6. Systems and Transducers updated September 9 2008 at the following website www fda gov downloads MedicalDevices DeviceRegulationandGuidance GuidanceDocuments UCM070911 pdf Transducer and System Care and Cleaning 4535 617 39631 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 A 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 A CAUTIONS Transducer and System Care and Cleaning 4535 617 39631 Attempting to clean or disinfect a transducer cable or connector b
7. 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 A WARNINGS e Always use protective eyewear and gloves when cleaning disinfecting or sterilizing any equipment e In intraoperative applications sterilized transducers should be used with sterile gel and a sterile transducer cover e Sterile transducer covers are disposable and must not be reused e ifa pre mixed solution is used be sure to observe the solution expiration date e Transducers must be cleaned after each use Cleaning the transducer is an esse
8. 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 Before performing this procedure read Warnings and Cautions on page 7 Transducer Care and Operator Safety on page 10 and Warnings and Cautions for TEE Transducer Care on page 26 The automated endoscopy reprocessor AER disinfector can be used only with specific transducers For information on the transducers that are compatible see the Philips Ultrasound Transducer Care website www healthcare philips com us products ultrasound transducers transducer_care Methods for disinfecting transesophageal TEE and non TEE transducers differ For non TEE transducers see Disinfecting Non TEE Transducers by Immersion on page 22 1 Disconnect the transducer from the system 2 Follow the AER manufacturer s 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 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing TEE Transducers Sterilization of TEE Transducers Steri
9. spray Connector strain relief Connector Cable Transducer strain relief Disinfecting the Cable Strain Reliefs and Connector 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 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 Transducer and System Care and Cleaning 4535 617 39631 1
10. to perform the procedure Transducers should not be left soaking in gel e Do not use gels that contain mineral oil or lotion Such products may damage the transducer and void the warranty Gels listed here are recommended because of their chemical compatibility with product materials Some recommended gels include e Aquasonic 100 e Aquasonic Clear e Carbogel ULT e ECG Gel Nicom e Nemidon Gel e Scan For additional compatibility information call Philips at 800 722 9377 North America or your local Philips representative outside North America Transducer and System Care and Cleaning 4535 617 39631 43 44 Related Care Information Transducer Storage and Transport Use the appropriate guidelines for storing transducers for transport and daily and long term storage Storage for Transport If a carrying case is provided with your transducer always use the carrying case to transport the transducer from one site to another Follow these guidelines to properly store transducers for transport e Make sure that the transducer is clean and disinfected before placing it in the case to avoid contaminating the foam that lines the carrying case e Place the transducer in the case carefully to prevent kinking of the cable e Before closing the lid make sure that no part of the transducer is protruding from the case e Wrap the case in plastic material containing air pockets such as Bubble Wrap material and pack the wrapped ca
11. 7 and Transducer Care and Operator Safety on page 10 A 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 Usea 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 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 18 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing Non TEE Transducers O Identifies the parts to wipe or
12. 9 Hi 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 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 Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label 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 gh level Disinfection of Non TEE Transducers High level disinfection of non TEE transducers uses the immersion method Before disinfecting a tra nsducer read Warnings and Cautions on page 7 and Transducer Care and Operator Safety on page 10 A WARNING If a pre mixed disinfectant is used be sure to observe the expiration date AN ca 20 UTIONS Always use protective eyewear and gloves when cleaning and disinfecting any equipment Using non recommended disinfectants using incorrect solution strengt
13. 9589 Telephone 800 445 6741 USA and Canada 1 319 248 6757 International Fax 877 329 2482 USA and Canada 1 319 248 6660 International E mail info civco com Internet www civco com Customer Service Customer service representatives are available worldwide to answer questions and to provide maintenance and service Please contact your local Philips representative for assistance You can also contact the following office for referral to a customer service representative or visit the Philips Healthcare Contact Us website www healthcare philips com main about officelocator index wpd Philips Ultrasound Inc 22100 Bothell Everett Highway Bothell WA 98021 8431 USA 800 722 9377 Transducer and System Care and Cleaning 4535 617 39631 45 46 Related Care Information Transducer and System Care and Cleaning 4535 617 39631
14. 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 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 Transducer and System Care and Cleaning 4535 617 39631 13 14 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
15. Organic and inorganic matter Duration of exposure Biofilms Choosing Disinfectants and Cleaning Solutions To choose the disinfectant and cleaning solutions for your transducers see the Philips Ultrasound Transducer Care website www healthcare philips com us products ultrasound transducers transducer_care or the User Manual for your ultrasound system The website includes a compatibility table that lists the disinfectants and cleaning solutions that are compatible with the transducers available for your system The tables are organized by system name and presented in PDF format on the website Transducer and System Care and Cleaning 4535 617 39631 35 Disinfectants NOTE TEE transducers require unique methods for disinfection See High Level Disinfection of TEE Transducers on page 28 or Disinfecting TEE Transducers with an AER on page 30 Based on material compatibility testing product use profile and active ingredients Philips has approved for use the following types of low level disinfectants used as a spray or wipe for surface skin contact and transvaginal or transrectal probes according to the compatibility restrictions in the tables Sodium hypochlorite based for example 10 household bleach solution with active sodium hypochlorite at approximately 0 6 Quaternary ammonium QUAT based for example products that contain n alkyl x benzyl ammonium chloride solution where x can be any organic functional group
16. a 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 e Follow the disinfectant manufacturer s instructions very carefully For example the manufacturer of Cidex OPA recommends soaking transducers three times in fresh water e Usea protective transducer cover during endocavity and TEE studies e Use a sterile protective transducer cover with sterile ultrasound transmission gel during intraoperative and biopsy studies e 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 Transducer and System Care and Cleaning 4535 617 39631 21 22 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 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 healthca
17. alopathy on page 12 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing Non TEE Transducers A WARNINGS e Transducer covers are disposable and must not be reused e Ifan 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 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 Transducer and System Care and Cleaning 4535 617 39631 15 16 Cleaning Disinfecting and Sterilizing Non TEE Transducers Connector housing Transducer strain relief Transducer housing Connector cover optional Connector electrical contacts under cover Transducer lens Non TEE Transducer Components Cleaning Non TEE Transducers Cables and Connectors These general cleaning instructions must be followed for all non TEE transducers cable
18. 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 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 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 and Cleaning 4535 617 39631 33 Disinfectants Disinfectants Read this information before performing disinfection and sterilization procedures It discusses recommended disinfectants and choosing an appropriate disinfectan
19. contact CIVCO Medical Solutions see Supplies and Accessories on page 45 and Customer Service on page 45 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 Transducer and System Care and Cleaning 4535 617 39631 Transducer Care and Operator Safety transesophageal echocardiography TEE transducers It also is not used on Philips ECG cables for ultrasound products A WARNINGS e Transducer covers can contain natural rubber latex which may cause allergic reactions in some individuals e 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 O
20. e wiped off immediately to prevent permanent damage Disinfecting System Surfaces Before performing this procedure read Disinfectants for System Surfaces Except Display Screens on page 39 Because the system is a piece of medical equipment that contains several circuit boards extensive service diagnostics and complex operating software Philips recommends that only trained personnel service the system WARNING Always use protective eyewear and gloves when cleaning and disinfecting any equipment Transducer and System Care and Cleaning 4535 617 39631 Related Care Information A CAUTIONS 5 Use only compatible disinfectants on system surfaces Do not spray disinfectant directly on system surfaces When wiping do not allow disinfectant to pool or run on system surfaces In either case disinfectant may leak into the system damaging the system and voiding the warranty Wipe only with a cloth or applicator that is lightly dampened If you use an isopropyl alcohol solution for disinfection ensure that the solution is only 70 alcohol or less Solutions of more than 70 alcohol can cause product damage Turn off the system and disconnect the system power cord from the wall outlet Clean the system according to the procedures in Cleaning the System and ECG Equipment on page 37 Choose the disinfection solution compatible with your system and follow the label instructions for preparation and solution strength If a pre
21. eccdstededeceevecdececcsdede 34 ABOUT DISINTECKANES i IE EN EEEE EEEE EEN AEE AAEE EE AT ENA 34 Choosing Disinfectants and Cleaning Solutions ccccscsccccecessssssesnececececesseseesaeaeeeeeeeseeseaeaeeeeesessesseeeesens 35 Related Care Information cicccccsccesscescecccest isora aniio i rn NaN NONON E EERE AA OARA I DEVAN SER A 37 SystemiMaintenance sear e ara aea taaa aa e a ENa E ae Eae aa rio aere Ea ae eaa Ein 37 Ultrasound Transmission Gels ccc csceisees elicaadessescacsecctaens EEEE NE EVAO NE EEE AN 43 Transducer Storage and Transport serta ara ia ei aa e E aE a a EEE i a EAEE REEN 44 Supplies Accessories ANd C stomer Service o ecccecessssssssececececessesnaaecaeeeeeceseeseeseseeeeeeceseeasesaeeeeeeeeeeeseesees 45 Transducer and System Care and Cleaning 4535 617 39631 3 Contents 4 Transducer and System Care and Cleaning 4535 617 39631 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 transd
22. ed 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 e 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 e Ifan allergic reaction does occur and latex is suspected advise the patient of a possible latex sensitivity and consider an immunologic evaluation e 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 WARNING If a sterile transducer cover becomes co
23. erse 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 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 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 Transducer and System Care and Cleaning 4535 617 39631 27 28 Cleaning Disinfecting and Sterilizing TEE Transducers 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 exam
24. he 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 Non TEE Transducer Use Example Classification Care Method Contacts intact skin Curved linear xMatrix Noncritical Low Level Disinfection of Non TEE Transducers and sector transducers on page 19 Contacts mucous Endocavity Semi critical High level Disinfection of Non TEE Transducers membranes on page 20 Enters otherwise sterile Intraoperative and Critical High level Disinfection of Non TEE Transducers tissue laparoscopic on page 20 OR Sterilization of Non TEE Transducers on page 23 TEE Transducer Use Example Classification Care Method Contacts mucous Transesophageal TEE Critical High Level Disinfection of TEE Transducers on membranes page 28 OR Sterilization of TEE Transducers on page 31 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
25. hs 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 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing Non TEE Transducers A 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 are
26. ine 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 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 Transducer and System Care and Cleaning 4535 617 39631 25 26 Cleaning Disinfecting and Sterilizing TEE Transducers Connector housing Connector strain relief Control housing strain relief Flexible shaft gastroscope Transducer lens Transducer controls Control housing Distal tip Control housing strain relief TEE Transducer Components Warnings and Cautions for TEE Transducer Care NOTE All imaging transducers are rated at a minimum IPX7 in accordance with IEC 60529 Degrees of P
27. ing 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 Transducer and System Care and Cleaning 4535 617 39631 Choosing the Correct Transducer Care Method O Identifies the parts of the transducer that can be cleaned with alcohol Non TEE transducer TEE transducer Alcohol Compatible Parts of Transducers Transducer and System Care and Cleaning 4535 617 39631 10 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
28. is an essential step before effective disinfection or sterilization Be sure to follow the manufacturer s instructions when using disinfectants Transducer and System Care and Cleaning 4535 617 39631 31 AN ca Cleaning Disinfecting and Sterilizing TEE Transducers UTIONS 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 32 Disconnect the transducer from the system and remove any accessories attached to or covering the transducer 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 Use water to gently rinse the distal tip and flexible shaft thoroughly Do not rinse or immerse the handle steering mechanism cable or connector Choose a sterilization solution compatible with your transducer Follow the label instructions for preparation and solution strength If a pre mixed solutio
29. lization 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 on page 28 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 on page 6 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 the Web site for your Philips Ultrasound system Before performing this procedure read Warnings and Cautions on page 7 Transducer Care and Operator Safety on page 10 and Warnings and Cautions for TEE Transducer Care on page 26 A WARNINGS e Always use protective eyewear and gloves when cleaning disinfecting or sterilizing any equipment e In intraoperative applications sterilized transducers should be used with sterile gel and a sterile transducer cover e Sterile transducer covers are disposable and must not be reused e If a pre mixed solution is used be sure to observe the solution expiration date e Transducers must be cleaned after each use Cleaning the transducer
30. lution expiration date For information on the disinfectants that are compatible with TEE transducers see the Philips Ultrasound Transducer Care website www healthcare philips com us products ultrasound transducers transducer_care Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing TEE Transducers 5 Disinfect the distal tip and flexible shaft by placing them into the appropriate disinfectant as shown in the illustration Follow 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 Do not immerse beyond this point 5 cm 2 in from the strain relief Immersing the Distal Tip and Flexible Shaft of TEE Transducers 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 Gently dry the distal tip and flexible shaft with a sterile cloth or pad or allow it to air dry 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 solu
31. mixed solution is used be sure to observe the solution expiration date Wipe system surfaces with the disinfectant following disinfectant label instructions for wipe durations solution strengths and disinfectant contact duration Ensure that the solution strength and duration of contact are appropriate for the intended clinical application Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label Regularly clean the outside of the system as described in Cleaning the System and ECG Equipment on page 37 Cleaning the Trackball Cleaning the trackball regularly prolongs its useful life and prevents service calls Oe a a Pe Remove the ring around the trackball using the appropriate procedure for your system Lift the trackball out of the mounting area Clean the trackball and the mounting area with a lint free cloth or a small brush Place the ball back on the mounting area With your fingers screw the ring back on Transducer and System Care and Cleaning 4535 617 39631 41 Related Care Information Cleaning the System Air Filter WARNING Before performing maintenance or cleaning always turn off the system and then disconnect the system from the wall outlet CAUTIONS e Turn off power before you remove the air filter Do not turn on power without the air filter installed e Ensure that air filter is dry before installing it Installing a wet or damp air filter can damage the
32. mpromised 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 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 Transducer and System Care and Cleaning 4535 617 39631 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 A 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
33. n is used be sure to observe the solution expiration date For information on the disinfectants that are compatible with TEE transducers see the Philips Ultrasound Transducer Care website www healthcare philips com us products ultrasound transducers transducer_care 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 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing TEE Transducers Do not immerse beyond this point 5 cm 2 in from the strain relief Immersing the Distal Tip and Flexible Shaft of TEE Transducers 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 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
34. ne 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 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 e 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 Transducer and System Care and Cleaning 4535 617 39631 11 12 Transducer Care and Operator Safety e If latex sensitivity is suspect
35. ntial step before effective disinfection or sterilization Be sure to follow the manufacturer s instructions when using disinfectants Transducer and System Care and Cleaning 4535 617 39631 23 AN ca Cleaning Disinfecting and Sterilizing Non TEE Transducers UTIONS 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 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
36. or pieces of peripheral equipment because they contain electromechanical devices If exposed to constant and excessive environmental dust and humidity these devices will suffer in both performance and reliability It is essential to clean the transducers used with your ultrasound system The cleaning procedures vary for the different types of transducers and their uses For detailed instructions on how to clean and maintain each type of transducer used with the system including disinfectant compatibility see Transducer Care Overview on page 5 System Control Panel Maintenance The system control panel and other outer surfaces are most likely to be affected by liquid spills and other materials such as excessive amounts of gel These materials may seep into electrical components under the panel and cause intermittent failures During preventive maintenance look for such potential problems including loose knobs and worn controls Cleaning the System and ECG Equipment Use this method to clean the system and the electrocardiogram ECG cables leads and electrodes You can use a mild soap solution on most surfaces If the equipment has come in contact with blood or infectious material you can clean most surfaces with a 70 solution of isopropyl alcohol For instructions on disinfecting system surfaces see Disinfectants for System Surfaces Except Display Screens on page 39 Transducer and System Care and Cleaning 4535 617 39631 37
37. ovements 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 in formation to users This product may contain remanufactured parts equivalent to new in performance or parts that have had incidental use Non Philips product names may be trademarks of their respective owners Transducer and System Care and Cleaning 4535 617 39631 Contents Contents Transducer Care Overview sccsceds ciclsdecssass leccssccuscdsesecesteses ctetecseiecedsieteetsctdsssieeddssedstsseceansesesdsiesssccssesedectesstet 5 Choosing the Correct Transducer Care Method sssssscccccsssssssssssesecceecccsesssssssessceeeeccsessssssssesceeeeaesssegs 6 Warnings andi Cautions esnin a cdveh aban a T a a a a a a ia T 7 Transducer Care and Operator Safety csssssssssscccscccccsssssssssscecesccccassssssssesseceecanccssssssesssscscaaaassssseees 10 Latex Product Alert dai E E E A E N E TAE N E SE E O S 10 Transmissible Spongiform Encephalopathy cccscssccccccecsssessscecceceescsssesseaeseeeeeeceseeseaeaaeseeeessesseaagesseeeees 12 Mieco COMTHON arisia ek a AEE E AEAEE AA A E ENEE A ETE AE TET A iarevies 12 Transducer COVE Sis diain AAE a AE E AE ANTEE AORE OAE OEA OAIR UNAR e TETEE AE ARNO 14 Cleaning Disinfecting and Sterilizing Non TEE Transducers sssssssssessssssosoose
38. ple the manufacturer of Cidex OPA recommends a minimum of 12 minutes 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 the Web site for your Philips Ultrasound system Before performing this procedure read Warnings and Cautions on page 7 Transducer Care and Operator Safety on page 10 and Warnings and Cautions for TEE Transducer Care on page 26 Cleaning and Disinfecting TEE Transducers 1 Disconnect the transducer from the system and remove any accessories attached to or covering the transducer 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 Use water to gently rinse the distal tip and flexible shaft thoroughly Do not rinse or immerse the handle steering mechanism cable or connector 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 so
39. 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 For information on ordering transducer covers bite guards and other supplies
40. re philips com us products ultrasound transducers transducer_care 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 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 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 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 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing Non TEE Transducers 7 Air dry or towel dry with a sterile cloth according to the instructions on the
41. rotection 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 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing TEE Transducers A 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 imm
42. s 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 1 After every patient study use a moist cloth to remove the ultrasound transmission gel from the transducer 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 Transducer and System Care and Cleaning 4535 617 39631 Cleaning Disinfecting and Sterilizing Non TEE Transducers 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 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 When cleaning
43. se in a cardboard carton e To avoid damaging the shaft or steering mechanism of TEE transducers do not bend or coil the flexible shaft of the transducer in less than a 0 30 m 1 ft diameter circle Daily and Long Term Storage Follow these guidelines to protect your transducer e Always store transducers in the transducer holders on the side of your system or on a securely mounted wall rack when you are not using them e Ensure that the transducer holders are clean before storing transducers see Disinfecting System Surfaces on page 40 e Avoid storing transducers in areas of temperature extremes or in direct sunlight e Store transducers separately from other instruments to avoid inadvertent transducer damage e When storing transducers use the cable management clips to secure the transducer cable e Before storing transducers make sure they are thoroughly dry e For TEE transducers be sure the distal tip is straight and protected before storing the transducer e Never store a TEE transducer in the carrying case except to transport it Transducer and System Care and Cleaning 4535 617 39631 Related Care Information Supplies Accessories and Customer Service Supplies and Accessories To order ECG trunk cables lead sets and electrodes transducer covers bite guards biopsy guides and other supplies and accessories contact CIVCO Medical Solutions CIVCO Medical Solutions 102 First Street South Kalona IA 52247
44. ssssssesoosoosssssssssooosssssesseeoe 15 Cleaning Non TEE Transducers Cables and Connectors ccccccccccsssessssececeeecessessaeceeceeecesseseaeaeeeeesesseseeges 16 Cleaning and Disinfecting Cables and Connectors sssssssssssresssseseserresssssssesereesrsssserrretenssssensrrernessssernes 18 Low Level Disinfection of NON TEE Transducers cccsssccecsessececesesececeeuececeenaeeeecsesaeeececeaeeesseaeeeeeeeseeeaaes 19 High level Disinfection of NON TEE Transducers s esseessssssesenressssssseserersrssssesereesnessssesrrernnssssrsrenenseeseenn 20 Sterilization of NON TEE Transducers ccccccccsssececsssnececeesnececcsesneeecscaeeecseaaeeecseaeeecssaeeeeeseaeeeeseeeeeesaeeeeees 23 Cleaning Disinfecting and Sterilizing TEE Transducers sssssessesesssosssssesesoosossssessssooocoosesesssssoososseseessse 25 Warnings and Cautions for TEE Transducer Care cccccccccsssessnsececececsesennsaecceecesesssesnaaeseceescesseaaaeeeeeeeeeeeeess 26 High Level Disinfection of TEE Transducers ccccsscccccccececsssensssecececeeceseeseeaeseceeeeceseeseseaeeeeeeeseesseseeeeseeeseea 28 Disinfecting TEE Transducers with an AER ccccccesssssececececseseneeaeeeeeeeeceseeseaaeseeeescesseeseasaeeeeeesssesasseseseeeeea 30 Sterilization Of TEE Transducers ccccccccssccccscssnecececsneeececsneeeeceeaeeecseaeeeceesaaeeeeeeaeeeeeeaaeeeeeeaaeceaeeeeesesaeeeeees 31 Disinfectants nonai EE E E N S cele cabadcccccdecdelecelcobev
45. such as ethyl and methyl and so on concentration at use should be less than 0 5 total for all QUATs listed Accelerated hydrogen peroxide based Activated hydrogen peroxide based Alcohol or alcohol plus QUAT based product alcohol content cannot exceed 70 You may also use products not specifically listed in the compatibility tables but with similar active ingredients as indicated above and marketed for medical use Because of the large number of available cleaning and disinfection products it is impossible to have an all inclusive list If you are unsure of the suitability of a particular product please contact your Philips representative for assistance For more information 36 www healthcare philips com us products ultrasound transducers transducer_care In North America call Philips at 800 722 9377 Outside North America contact your local Philips representative Transducer and System Care and Cleaning 4535 617 39631 Related Care Information Related Care Information System Maintenance Maintenance should be performed regularly and as needed Because the system is a piece of medical equipment that contains several circuit boards extensive service diagnostics and complex operating software Philips recommends that only trained personnel service the system Cleaning and Maintaining the System It is important to clean and maintain the ultrasound system and peripherals Thorough cleaning is particularly important f
46. system The system air filters should be inspected every week and cleaned as needed If you decide to clean the air filters with soap and water you may want to install a spare filter while the other filter is drying Additional air filters can be ordered from Philips For the location of the air filter see your system User Manual 1 Locate the air filter handle 2 Pull the air filter handle straight out until the filter is completely removed from the system 3 Inspect the filter Depending on the condition of the air filter vacuum or rinse the filter with water to clean it If the filter is worn out or cannot be cleaned replace it with a spare 4 To reinstall the filter slide the filter into place NOTE Some systems have a setting for setting the air filter maintenance status For instructions see your system User Manual Transducer and System Care and Cleaning 4535 617 39631 Related Care Information Ultrasound Transmission Gels For proper transmission of the acoustic beam use the ultrasound transmission gel supplied by or recommended by Philips or another glycol glycerol or water based acoustic coupling medium Products that do not contain mineral oil are acceptable for use Never use lotion based products A WARNING For intraoperative applications use only the Sterile Aquasonic or Sterile Ultraphonic gel provided with the transducer cover A CAUTIONS e Do not apply gel to the transducer until you are ready
47. t for the required level of disinfection You must refer to Choosing Disinfectants and Cleaning Solutions on page 35 for the chemical compatibility of disinfectants and cleaners with specific transducers Additionally the tables indicate if a device can be sprayed or wiped only or if it can be soaked About Disinfectants 34 WARNINGS Not all disinfectants are effective against all types of contamination Ensure that the disinfectant type is appropriate for the type of transducer and that the solution strength and time of contact are appropriate for the intended clinical use Disinfectants listed in this section 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 Association for Professionals in Infection Control the U S Food and Drug Administration and the U S Centers for Disease Control If a pre mixed solution is used be sure to observe the solution expiration date Always use protective eyewear and gloves when cleaning and disinfecting any equipment The level of disinfection required for a device is dictated by the type of tissue it will contact during use 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
48. the Correct Transducer Care Method on page 6 For more information 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 Transducer and System Care and Cleaning 4535 617 39631 Disinfectants A CAUTIONS Using a non recommended disinfection solution using incorrect solution strength or immersing a transducer deeper or longer than recommended can damage the device and voids the warranty 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 Factors Affecting Disinfectant Efficiency The following factors will affect the efficiency of a disinfectant solution Number and location of microorganisms Innate resistance of microorganisms Concentration and potency of disinfectants Physical and chemical factors
49. the lens use a blotting motion rather than a wiping motion 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 NOTE If you use cleaning wipes it may be unnecessary to rinse the transducer with water Always follow the product label recommendations 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 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 Transducer and System Care and Cleaning 4535 617 39631 17 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
50. tion to clean the cable the strain reliefs and the connector A soft bristled brush can be used only the metal surfaces of the connector 11 Choose the disinfection solution compatible with your 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 TEE transducers see the Philips Ultrasound Transducer Care website www healthcare philips com us products ultrasound transducers transducer_care 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 Transducer and System Care and Cleaning 4535 617 39631 29 30 Cleaning Disinfecting and Sterilizing TEE Transducers O Identifies the parts to disinfect Connector strain relief Control housing strain relief Control housing strain relief Connector Cable Disinfecting the Cable Strain Reliefs and Connector of TEE Transducers 13 Hang the transducer on a wall mounted rack and let it air dry 14 Examine the transducer
51. ucer 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 Cleaning and Disinfecting Transducers Disinfectants Related Care Information e Choosing the Correct Transducer e About Disinfectants on page 34 e System Maintenance on page 37 Care Method on page 6 e Choosing Disinfectants and Cleaning Ultrasound Transmission Gels on e Transducer Care and Operator Solutions on page 35 page 43 Safety on page 10 e Transducer Storage and Transport e Cleaning Disinfecting and Sterilizing on page 44 Non TEE Transducers on page 15 e Supplies Accessories and e Cleaning Disinfecting and Sterilizing Customer Service on page 45 TEE Transducers on page 25 Transducer and System Care and Cleaning 4535 617 39631 5 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 t
52. urfaces of the system can be disinfected using a compatible disinfectant with a wipe method System surfaces include monitor screens the touch screens and plastic and painted surfaces The following products can be used on all system surfaces except monitor screens and touch screens e Mild soap solution e 70 isopropyl alcohol IPA e T Spray II quaternary ammonium based Transducer and System Care and Cleaning 4535 617 39631 39 Related Care Information e Opti Cide 3 quaternary ammonium isopropyl alcohol based e Sani Cloth HB quaternary ammonium based e Sani Cloth Plus quaternary ammonium isopropyl alcohol based e 0 5 Accelerated hydrogen peroxide e Other low and intermediate level disinfectants marketed for use on medical instruments and based on quaternary ammonium compounds QUAT accelerated hydrogen peroxide AHP or sodium hypochlorite NaOCl equal to or less than 0 6 are approved for use in disinfecting system surfaces CAUTION Do not use acetone MEK paint thinner or other strong solvents to clean plastics The following products can be used on monitor screens and touch screens e Cleaners designed for LCDs e Deionized water Disinfectants may be used when necessary but are not recommended for routine cleaning Do not use glass cleaners or products containing alcohol Use microfiber cloth do not use paper towels Surfaces are resistant to ultrasound gel alcohol and disinfectants but if used must b
53. y 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 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 clean
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