Cleaning and Disinfecting X-Porte Products
Contents
1. Tristel Wipes V V Virex II 256 v Virox 5 RTU Wipes v v V v Wex Cide V4 VA VA VA Wood Wyant Ultra Wipes V v Acceptable for use X Porte SonoSite and the SonoSite logo are trademarks or registered trademarks of FUJIFILM SonoSite Inc in various jurisdictions All other trademarks are the property of their respective owners Caution United States federal law restricts this device to sale by or on the order of a physician Manufacturer FUJIFILM SonoSite Inc 21919 30th Drive SE Bothell WA 98021 USA T 1 888 482 9449 or 1 425 951 1200 F 1 425 951 1201 EC Authorized Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Australia Sponsor FUJIFILM SonoSite Australasia Pty Ltd Suite 9 13a Narabang Way Belrose New South Wales 2085 Australia 07 2013 Copyright 2013 FUJIFILM SonoSite Inc All Rights reserved CE 0086 P16529 01 162. X Porte ultrasound system Disinfectant Airkem A 33 Hydrogen Peroxide 3 Anios Wipes Incidin Plus 1 Aniosyme DD1 5 e Incidin Plus 3 Anioxide 1000 e Medzyme Asepti HB Metricide OPA Plus Asepti Wipe Il Mikrobac forte Cidalkan Lingettes Sani Cloth HB Cidex Simple Chlor Cidex OPA Steranios 2 Table 1 Compatible disinfectants for the X Porte ultrasound system Disinfectant e Cidex Plus Steranios 20 e Clinell Universal Sanitising Wipes Trigene Advance Wipes Control Ill e Virox 5 Wipes Dynacide PA e Wex Cide e Endosporine Transducers WARNING To avoid electrical shock before cleaning disconnect the transducer from the system Caution Transducers must be cleaned after every use Cleaning transducers is necessary prior to effective disinfection Ensure that you follow the manufacturer s instructions when using disinfectants Caution Do not use a surgeon s brush when cleaning transducers Even the use of soft brushes can damage a transducer Use a soft cloth Caution Using a non recommended cleaning or disinfection solution incorrect solution strength or immersing a transducer deeper or for a longer period of time than recommended can damage or discolor the transducer and void the transducer warranty Caution Do not allow cleaning solution or disinfectant into the transducer connector Caution Do not allow disinfectant to contact metal surfaces Use a soft cloth lightly dampened
3. in a mild soap or compatible cleaning solution to remove any disinfectant that remains on metal surfaces Caution Attempting to disinfect a transducer or transducer cable using a method other than the one included here can damage the transducer and void the warranty Clean the transducer prior to disinfecting to remove any particulate matter or bodily fluids To disinfect the transducer and its cable use the immersion method or the wipe method You can disinfect the transducer scanning surface and cable using a compatible disinfectant or disinfectant device For disinfectants compatible with standard transducers see Compatible disinfectants for standard transducers For disinfectants compatible with specialty transducers such as the ICTxp see Compatible disinfectants for specialty transducers SonoSite recommends the use of high level disinfectants with specialty transducers such as the ICTxp Cleaning and disinfecting transducers To clean a transducer 1 2 3 4 5 Disconnect the transducer from the system Remove any transducer sheath Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution Apply the solution to the cloth rather than the surface Rinse with water or wipe with water dampened cloth then wipe with a dry cloth To disinfect a transducer wipe method 1 2 Clean the transducer Mix the disinfectant solution compatible with the transducer foll
4. Cleaning and Disinfecting X Porte Products 2 SonoSite P16529 01 FUJ FILM Table of contents INCROGUCTION cssissssessesssssisssssssscsoaccessescestensessvessacsssevsessnsessssenseasseasseucescessscsessseuesssesbsensessseasessensees 1 Ultrasound SYSECINI lt scisussscissces s neccsvstesuccanvevnscscsshe sectwseneyetdoulechoanseseaciseunsassnsecsenaesdendascaneusecesestnees 2 EE N A A ET O O OE TE TO OE OO IE EP OI 4 a O O EJ O AE OPE ET TE TT O VO LOTOV 9 Introduction SonoSite tests disinfectants and disinfectant devices for use with its systems transducers and accessories This document includes instructions for cleaning and disinfecting the X Porte ultrasound system transducers and accessories This document does not have the following regulatory information for disinfectants USA FDA registration and listing 510 k clearance and or EPA registration CE approval Before using a disinfectant confirm that its regulatory status is appropriate for your jurisdiction and use Verify expiration dates on chemicals When disposing of chemicals follow manufacturer recommendations and local regulations WARNING Disinfectants and cleaning methods listed are recommended by SonoSite for compatibility with product materials not for biological effectiveness Refer to the disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses The level of disinfection required for a device is dictated by
5. o clean and disinfect accessories 1 If necessary unplug the power supply and detach any cables 2 Clean the exterior surfaces of the accessory using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface 3 Mix the disinfectant solution compatible with the accessory following disinfectant label instructions for solution strengths and disinfectant contact duration See Disinfectant compatibility with SonoSite accessories 4 Wipe surfaces with the disinfectant solution 5 Air dry or towel dry with a clean cloth Cleaning the footswitch or ECG cable To clean the footswitch Use the disinfecting recommendations in the peripheral manufacturer s instructions when disinfecting the footswitch Caution To avoid damaging the footswitch do not sterilize It is not intended for use ina sterile environment 1 Dampen a non abrasive cloth with one of the following products Isopropyl alcohol Soap and water e Cidex Sodium Hypochlorite 5 25 Bleach diluted 10 1 10 2 Wring out cloth until slightly wet and then gently rub soiled area until clean To clean and disinfect the ECG cable wipe method Caution To avoid damaging the ECG cable do not sterilize 4 Remove the cable from the system Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution A
6. owing disinfectant label instructions for solution strengths and disinfectant contact duration Wipe surfaces with the disinfectant solution If the disinfectant s instructions include rinsing rinse with water or wipe with a water dampened cloth Then air dry or dry with a clean cloth Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident do not use of the transducer and contact SonoSite or your local representative To disinfect a transducer immersion method 1 2 Clean the transducer Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration Immerse the transducer into the disinfection solution not more than 12 18 inches 31 46 cm from the point where the cable enters the connector Follow the instructions on the disinfectant label for the duration of the transducer immersion Using the instructions on the disinfectant label rinse to the point of the previous immersion and then air dry or towel dry with a clean cloth Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident discontinue use of the transducer and contact SonoSite or your local representative Compatible disinfectants for standard transducers Table 2 Disinfectant device compatibility with X Porte standard transducers v Acceptable for use For informa
7. pply the solution to the cloth rather than the surface Wipe the surfaces with any of the following products Bleach sodium hypochlorite Cidex disinfectants Green soap Air dry or towel dry with a clean cloth Compatible disinfectants for accessories Table 4 Disinfectant compatibility with SonoSite accessories Airkem A 33 v Na si Alcohol Ethanol Alcohol Isopropyl 100 Alcohol Isopropyl 70 V Table 4 Disinfectant compatibility with SonoSite accessories continued Aniosyme DD1 5 v v v v Asepti HB V v VA v Asepti Wipe Il v v V v CaviWipes v v v VA Cidalkan Lingettes V V Cidex V VA VA V Cidex Plus VA VA VA VA Clorox Germicidal Wipe v 2 Table 4 Disinfectant compatibility with SonoSite accessories continued Coverage Germicidal Surface Wipes V V Coverage Plus Wipes v EN IH DisCide Ultra Disinfecting Towelettes V V DE aaa ma a JEKA Echo Clean Lingettes V V V EN TRN Endosporine v v VA VA prb i Gluco Chlor Wipes v Incidin Plus 1 V VA V Val Madacide 1 VA V Table 4 Disinfectant compatibility with SonoSite accessories continued Metricide OPA Plus V VA VA Val Nu Cidex v Rely On PeraSafe v v v Sani Cloth HB V VA VA Simple Chlor v v Staphene V V Steranios 20 v v v v T Spray v Table 4 Disinfectant compatibility with SonoSite accessories continued Trigene Advance Wipes v v v
8. rasound system Clean the ultrasound system prior to disinfecting to remove any particulate matter or bodily fluids To clean and disinfect the ultrasound system 1 Turn off the system Disconnect the system from power Press the Power button listen for the audio tone and then disconnect the AC input power cord from the stand base Caution Unplugging the AC power cord before you hear the tone may result in loss of data If you don t hear a tone then your system may be set up to mute all sounds To reinstate sounds see the topic titled Audio settings in the X Porte Help Clean the exterior surfaces using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface Mix the disinfectant solution compatible with the system following disinfectant label instructions for solution strengths and disinfectant contact duration See Compatible disinfectants for the X Porte ultrasound system Wipe surfaces with the disinfectant solution Air dry or towel dry with a clean cloth Compatible disinfectants for the X Porte ultrasound system You can disinfect the exterior surface of the ultrasound system which includes the stand clinical monitor touch panel system engine cups and cable hooks using any of the following chemically compatible disinfectants approved in your locale Table 1 Compatible disinfectants for the
9. the type of tissue it contacts during use To avoid infection ensure that the disinfectant type and the solution strength and duration are appropriate for the equipment For information see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology APIC and the FDA WARNING To avoid infection Always use protective eyewear and gloves when performing cleaning and disinfecting procedures Ensure that the solution expiration date has not passed Ultrasound system The ultrasound system includes the stand clinical monitor touch panel system engine cups and cable hooks WARNING Caution Caution Caution Caution Caution To avoid electrical shock before cleaning disconnect the system from the power supply Do not spray cleaners or disinfectant directly on the system surfaces Doing so may cause solution to leak into the system damaging the system and voiding the warranty Do not use strong solvents such as thinner or benzene or abrasive cleansers since these will damage the exterior surfaces Use only recommended cleaners or disinfectants on system surfaces Immersion type disinfectants are not approved for use on system surfaces When you clean the system ensure that the solution does not get inside the system controls or the battery compartment Do not scratch the LCD screen Cleaning and disinfecting the ult
10. tion and guidance on disinfection effectiveness and appropriate clinical use see the manufacturer s user manual Table 3 Disinfectant compatibility with X Porte standard transducers Accel TB Wipes v V Alcohol Reagent Ethanol V v VA Aniosyme DD1 5 VA VA V V v Asepti Wipe Il v v V4 v v Baxedin Pre Op V v v v VA CaviWipes v v v VA v Cidalkan Lingettes v v V4 Table 3 Disinfectant compatibility with X Porte standard transducers Cidex OPA v VA VA VA v Cleanisept Wipes v v v Clorox Germicidal Wipes v v v v VA Coverage Germicidal Surface Wipes V V V v V Coverage Spray v v V4 Dispatch Wipes v v v Echo Clean Lingettes V V V v V Endosporine v v v v VA Gluco Chlor Wipes v v v v VA Incidin Plus 1 v v v V4 VA Korsolex Extra V NA VA Table 3 Disinfectant compatibility with X Porte standard transducers Medzyme v v v VA VA MetriSponge v v v v v Mikrobac Tissues v v v VA v PerCept RTU Wipes v v v v v Protex Wipes v v v VA v Sani Cloth AF3 V VA VA v v Sani Cloth HB v VA VA VA v Sekusept v VA v Steranios 2 v v v v VA Tristel Solo VA VA VA VA VA T Spray Il v v v v V4 Co Table 3 Disinfectant compatibility with X Porte standard transducers Disinfectant C60xp L38xp HFL50xp L25xp P21xp Virex Il 256 v v VA VA V Virex TB v V v V4 v Virox 5 RTU Wipes v v v Wet Task Wipes v v VA v v Wet Wipe Disinfection v v Va Wipes Plus Disinfecting Wipes V v v V v
11. v Acceptable for use Compatible disinfectants for specialty transducers SonoSite recommends the use of high level disinfectants with specialty transducers In the U S 510 k approved high level disinfectants compatible with SonoSite specialty transducers include Cidex Cidex OPA Cidex Plus Metricide OPA Plus and the Nanosonics Trophon EPR disinfectant device Disinfectant device compatibility with X Porte specialty transducers ICTxp The Nanosonics Trophon EPR disinfectant device is acceptable for use with X Porte speciality transducers For information and guidance on disinfection effectiveness and appropriate clinical use see the manufacturer s user manual Disinfectant compatibility with X Porte specialty transducers ICTxp The following disinfectants are acceptable for use with X Porte specialty transducers e Cidex e Cidex OPA Cidex Plus Metricide OPA Plus Accessories To clean the footswitch or ECG cable see Cleaning the footswitch or ECG cable Use the cleaning and disinfecting recommendations in the peripheral manufacturer s instructions when cleaning or disinfecting peripherals WARNING To avoid electrical shock always disconnect the power supply before cleaning the PowerPark Cleaning and disinfecting accessories Clean accessories prior to disinfecting You can disinfect the exterior surface of accessories using a recommended disinfectant See Disinfectant compatibility with SonoSite accessories T
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