FUJIFILM SonoSite Products Cleaning and Disinfecting User Guide

Manufacturer

EC Authorized Representative

Australia Sponsor

FUJIFILM SonoSite, Inc.

Emergo Europe

FUJIFILM SonoSite Australasia Pty Ltd

21919 30th Drive SE

Molenstraat 15

114 Old Pittwater Road

Bothell, WA 98021 USA

2513 BH, The Hague

BROOKVALE, NSW, 2100

T: 1-888-482-9449 or 1-425-951-1200

The Netherlands

Australia

F: 1-425-951-1201

Caution

United States law restricts this device to sale by or on the order of a physician.

X-Porte, iViz, Edge, M-Turbo, NanoMaxx, S Series, SonoSite, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. DICOM is a registered trademark of the National Electrical Manufacturers Association. All other trademarks are the property of their respective owners. Part Number: P22043-01 Publication Date: October 2015 Copyright © 2015 FUJIFILM SonoSite, Inc. All Rights reserved.

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CONTENTS

Chapter 1: Introduction About this guide 1 Conventions 1 Technical support 2

Chapter 2: Cleaning and disinfecting the iViz ultrasound system Cleaning and disinfecting 4 Cleaning and disinfecting the system and protective case 5 Cleaning and disinfecting the transducer 6 Determining the required cleaning and disinfection level 6 Level A: Intermediate-level disinfection (non-critical) 7 Level B: High-level disinfection (semi-critical) 10 Cleaning and disinfecting the transducer 10 Cleaning the iViz carry case 13 Storing 13 Transporting 13 Disposing of the system 13 Compatible cleaners and disinfectants (system and transducers) 14 Compatible cleaners and disinfectants (accessories) 17 Compatible high-level disinfectants compatible (transducers) 17

Chapter 3: Cleaning and disinfecting the X-Porte ultrasound system Before getting started 20 Cleaning and disinfecting 21 Determining the required cleaning and disinfecting level 21 Spaulding classifications 21 Clean and disinfect system and transducer to a high level (semi-critical uses) 22 Cleaning and disinfecting the system and transducer (semi-critical) 22 Clean and disinfect system and transducer to a low level (non-critical uses) 25 Cleaning and disinfecting the system and transducer (non-critical)26 Storing the transducer 27 Transporting the transducer 28 Compatible cleaners and disinfectants (system and transducers) 30 Compatible cleaners and disinfectants (system accessories) 34 Compatible high-level disinfectants (transducers) 38

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CONTENTS

Chapter 4: Cleaning and disinfecting the Edge ultrasound system Before getting started 43 Cleaning and disinfecting 44 Determining the required cleaning and disinfecting level 44 Spaulding classifications 44 Clean and disinfect system and transducer to a high level (semi-critical uses) 45 Cleaning and disinfecting the system and transducer (semi-critical)45 Clean and disinfect system and transducer to a low level (non-critical uses) 48 Cleaning and disinfecting the system and transducer (non-critical)49 Storing the transducer 50 Transporting the transducer 51 Compatible cleaners and disinfectants (system and transducers) 53 Compatible cleaners and disinfectants (system accessories) 56 Compatible high-level disinfectants (transducers) 61

Chapter 5: Cleaning and disinfecting the SonoSite Edge II ultrasound system Before getting started 64 Cleaning and disinfecting 65 Determining the required cleaning and disinfecting level 65 Spaulding classifications 65 Clean and disinfect system and transducer to a high level (semi-critical uses) 66 Cleaning and disinfecting the system and transducer (semi-critical)66 Clean and disinfect system and transducer to a low level (non-critical uses) 69 Cleaning and disinfecting the system and transducer (non-critical)70 Storing the transducer 71 Transporting the transducer 72 Compatible cleaners and disinfectants (system and transducers) 74 Compatible cleaners and disinfectants (system accessories) 78 Compatible high-level disinfectants (transducers) 81

Chapter 6: Cleaning and disinfecting the S Series ultrasound system Before getting started 85 Cleaning and disinfecting 86

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CONTENTS

Determining the required cleaning and disinfecting level 86 Spaulding classifications 86 Clean and disinfect system and transducer to a high level (semi-critical uses) 87 Cleaning and disinfecting the system and transducer (semi-critical)87 Clean and disinfect system and transducer to a low level (non-critical uses) 90 Cleaning and disinfecting the system and transducer (non-critical)91 Storing the transducer 92 Transporting the transducer 93 Compatible cleaners and disinfectants (system and transducers) 95 Compatible cleaners and disinfectants (system accessories) 99 Compatible high-level disinfectants (transducers) 103

Chapter 7: Cleaning and disinfecting the M-Turbo ultrasound system Before getting started 106 Cleaning and disinfecting 107 Determining the required cleaning and disinfecting level 107 Spaulding classifications 107 Clean and disinfect system and transducer to a high level (semi-critical uses) 108 Cleaning and disinfecting the system and transducer (semi-critical)108 Clean and disinfect system and transducer to a low level (non-critical uses) 111 Cleaning and disinfecting the system and transducer (non-critical)112 Storing the transducer 113 Transporting the transducer 114 Compatible cleaners and disinfectants (system and transducers) 116 Compatible cleaners and disinfectants (system accessories) 120 Compatible high-level disinfectants (transducers) 124

Chapter 8: Cleaning and disinfecting the NanoMaxx ultrasound system Before getting started 126 Cleaning and disinfecting 127 Determining the required cleaning and disinfecting level 127 Spaulding classifications 127 Clean and disinfect system and transducer to a high level (semi-critical uses) 128 Cleaning and disinfecting the system and transducer (semi-critical)128 Clean and disinfect system and transducer to a low level (non-critical uses) 131

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CONTENTS

Cleaning and disinfecting the system and transducer (non-critical)132 Storing the transducer 133 Transporting the transducer 134 Compatible cleaners and disinfectants (system and transducers) 136 Compatible cleaners and disinfectants (system accessories) 139 Compatible high-level disinfectants (transducers) 142

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Chapter 1: Introduction About this guide This guide contains instructions for cleaning and disinfecting SonoSite systems, transducers, and accessories. Each system is presented in its own chapter, with cleaning and disinfecting instructions designed specifically for that system. If your FUJIFILM SonoSite system is not listed here, refer to the system user guide, or contact FUJIFILM SonoSite for cleaning instructions.

Conventions The document follows these conventions: A WARNING describes precautions necessary to prevent injury or loss of life. A Caution describes precautions necessary to protect the products. A Note provides supplemental information. Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence. For labeling symbols used, see the corresponding ultrasound system user guide.

About this guide

1

Technical support To order sheaths, bite guards, tip covers, and other supplies, see www.civco.com. For more information or for technical support, contact FUJIFILM SonoSite as follows. Phone (U.S. or Canada)

877-657-8118

Phone (Outside U.S. or Canada)

425-951-1330, or call your local representative

Fax

425-951-6700

E-mail

[email protected]

Web

www.sonosite.com

Europe Service Center

Main: +31 20 751 2020 English support: +44 14 6234 1151 French support: +33 1 8288 0702 German support: +49 69 8088 4030 Italian support: +39 02 9475 3655 Spanish support: +34 91 123 8451

Asia Service Center

2

+65 6380-5581

Technical support

Chapter 2: Cleaning and disinfecting the iViz ultrasound system Cleaning and disinfecting ... 4 Cleaning and disinfecting the system and protective case ... 5 Cleaning and disinfecting the transducer ... 6 Determining the required cleaning and disinfection level ... 6 Level A: Intermediate-level disinfection (non-critical) ... 7 Level B: High-level disinfection (semi-critical) ... 10 Cleaning the iViz carry case ... 13 Storing ... 13 Transporting ... 13 Disposing of the system ... 13 Compatible cleaners and disinfectants (system and transducers) ... 14 Compatible cleaners and disinfectants (accessories) ... 17 Compatible high-level disinfectants compatible (transducers) ... 17

This chapter contains instructions for cleaning and disinfecting the iViz ultrasound system, transducers, and accessories. Use the FUJIFILM SonoSite recommendations when cleaning and disinfecting your ultrasound system, transducer, and accessories. Use the cleaning recommendations in the accessory manufacturer’s instructions when cleaning or disinfecting your accessories. The system and transducers must be cleaned and disinfected after each exam. It is important to follow these cleaning and disinfecting instructions without skipping any steps. See www.sonosite.com/transducers for images of transducers. Also included is a listing of disinfectants that SonoSite has tested and deemed compatible with the iViz system, transducers, and accessories. This information is presented in the following tables.  Table 2-1, “Cleaning and disinfection guidelines”on page 7 shows compatibility between disinfectants, the system, and transducers. Table 2-6, “Cleaners and disinfectants compatible with iViz accessories”on page 17 shows compatibility between disinfectants and accessories. Table 2-7, “High-level disinfectants compatible with iViz transducers”on page 17 shows compatibility between high-level disinfectants and transducers.

Note

The system and transducers must be cleaned and disinfected after each exam. It is important to follow these cleaning and disinfecting instructions without skipping any steps.

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Ensure that cleaning and disinfecting solutions and wipes are not expired. WARNINGS

Some cleaners and disinfectants can cause an allergic reaction to some individuals.

Cleaning and disinfecting The iViz ultrasound system consists of the system (tablet), accessory case, and transducer.

System (tablet)

Accessory case

Transducer

This section includes instructions for cleaning and disinfecting the iViz ultrasound system. The system must be cleaned and disinfected after each exam. It is important to follow this cleaning and disinfection process without shortening or skipping steps. Only use cleaners and disinfectants approved by FUJIFILM SonoSite on the iViz system. Be sure to observe the solution strength and duration requirements detailed in the cleaning and disinfection procedures. Included in this section are instructions for two levels of cleaning and disinfection for both the transducer and the system. The level of cleaning and disinfection required depends on the type of tissue the system comes into contact with during an exam. For more information, see “Cleaning and disinfecting the system and protective case” on page 5. The materials used in the iViz system are designed and tested to work with the cleaners and disinfectants listed in this chapter. The iViz system will not be damaged if cleaned according to the approved instructions and with the approved cleaners and disinfectants. Before using a disinfectant, confirm that it is appropriate for your facility’s use. Verify expiration dates, concentration, and efficacy of chemicals (for example, a chemical strip test).

4

Cleaning and disinfecting

When preparing, using, and disposing of chemicals, be sure to follow manufacturer recommendations and local regulations. WARNINGS Cautions

Residual chemicals from some disinfectants can cause an allergic reaction in some individuals. Follow the manufacturer’s cleaning label instructions for solution strengths and disinfectant contact duration. Check the expiration date on all cleaning and disinfection solutions and wipes. Do not use chemicals or wipes that have expired. Do not allow cleaning solution or disinfectant into the battery compartment, system controls, or transducer connector. Do not use strong solvents, such as thinner or benzene, or abrasive cleansers since these will damage the exterior surfaces. Use only FUJIFILM SonoSite recommended cleaners or disinfectants. Use only a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any disinfectant on metal surfaces.

Cleaning and disinfecting the system and protective case The following procedures can be used to clean and disinfect the system and protective case. Caution

Do not immerse the system or the protective case in any liquid.

To clean the system and protective case 1 Make sure the system is turned off. 2 Disconnect the transducer. 3 Remove the system from the protective case. 4 Using a soft, damp cloth (dampened with cleaner or disinfectant) or a premoistened disinfectant wipe, clean any particulate matter or bodily fluids from all system and protective case surfaces. Be sure to use only cleaners listed in Table 2-2, “Compatible cleaners and disinfectants”on page 7.  Wipe from clean areas to the soiled areas to avoid cross-contamination. WARNINGS

Cleaning and disinfecting

Wear the appropriate personal protective equipment (PPE), such as eyewear and gloves, recommended by the chemical manufacturer.

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Cautions

Do not spray cleaners or disinfectants directly on the system surfaces. Doing so may cause solution to leak into the system, damaging it and voiding the warranty. Do not allow moisture to get on the transducer connector or into the connector ports on the system. Do not scratch the display screen.

5 Verify that all gel, particulate matter, and bodily fluids have been removed. Note

Repeat steps 4-5 with new cleaning materials, if necessary.

To disinfect the system and protective case 1 Wipe all surfaces with a premoistened wipe or a cloth moistened with a compatible disinfectant listed in Table 2-2, “Compatible cleaners and disinfectants”on page 7. Apply the disinfectant solution to the cloth rather than applying it directly to surfaces. Follow the chemical manufacturer’s requirements for wet contact time. Caution

Use only FUJIFILM SonoSite recommended disinfectants. Using a nonrecommended disinfect solution or incorrect solution strength can damage or discolor the transducer and void the transducer warranty.

2 Allow the system to air dry following the chemical manufacturer’s requirements for wet contact time.

Cleaning and disinfecting the transducer Cleaning and disinfecting the transducer requires that you chose the proper cleaning and disinfecting level.

Determining the required cleaning and disinfection level Before cleaning, visually inspect the ultrasound system to determine that it is free of any unacceptable deterioration, such as corrosion, discoloration, pitting, or cracked seals. If damage is evident, discontinue use, and contact FUJIFILM SonoSite or your local representative. Spaulding classifications are a tool to help reduce cross-contamination and infection by specifying the level of cleaning and disinfecting required for your medical equipment. The Spaulding classification is based on the type of device, its usage, and the risk of infection. Based on these criteria, the iViz ultrasound system is classified as either non-critical or semi-critical, depending on how it is used.

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Determining the required cleaning and disinfection level

Each Spaulding classification mandates a specific level of cleaning and disinfection of the equipment before it can be used in the next exam. Use the following guide to determine the level of cleaning and disinfection for the iViz ultrasound system according to the appropriate Spaulding classification.

Table 2-1: Cleaning and disinfection guidelines If any part of the system came into contact with...

Then disinfect to the following level

Unbroken skin, no blood or bodily fluids (noncritical)

“Level A: Intermediate-level disinfection (noncritical)” on page 7

Broken skin, mucosal membranes, blood, and/or bodily fluids (semi-critical)

“Level B: High-level disinfection (semi-critical)” on page 10

Level A: Intermediate-level disinfection (non-critical) Clean and disinfect the system and protective case immediately after use. Be sure to follow the manufacturer's instructions when using cleaners and disinfectants. See “Cleaning and disinfecting the system and protective case” on page 5. For non-critical disinfection, clean the transducer as described in “To clean the transducer” on page 8, and then disinfect it as described in “To disinfect the transducer” on page 9. If the transducer has come into contact with broken skin, mucosal membranes, or blood, you must then do a high-level disinfection; see “Level B: High-level disinfection (semi-critical)” on page 10. The materials listed in Table 2-2, “Compatible cleaners and disinfectants”on page 7 are chemically compatible with the system and transducers. Confirm that the cleaners and disinfectants are appropriate for your facility’s use.

Table 2-2: Compatible cleaners and disinfectants Product

System

Protective case

Carry case

P21v transducer

Sani-Cloth AF3 (grey top) Sani-Cloth Bleach Wipes (yellow top) Sani-Cloth Plus (red top) Sani-Cloth HB (green top) Super Sani-Cloth (purple top)

Determining the required cleaning and disinfection level

7

Table 2-2: Compatible cleaners and disinfectants Product

System

Protective case

Carry case

P21v transducer

T-Spray II (PI-Spray II)

Note

Proper cleaning of the slot is important because good airflow through the slot improves cooling of the transducer electronics and extends the life of the equipment.

To clean the transducer 1 Clean the transducer cord using either a soft, damp, soapy cloth or a premoistened wipe. Start at the connector and wipe toward the scan head. Do not get any water or cleaner on the connector. 2 Clean all transducer surfaces using either a soft cloth dampened with cleaner or disinfectant or a premoistened wipe. Be sure to remove any gels or particulate matter. 3 Clean the transducer cooling slot using a thin, disposable instrument, such as a swab, to push a soft cloth lightly dampened with a cleaning solution or a premoistened wipe through the slot.

a Pull the cloth back and forth from one side of the slot to the other. b Pull the cloth up and down from the transducer connector to the transducer head.

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Determining the required cleaning and disinfection level

c Remove the cloth from the slot. d Dispose of the cloth and the instrument used to insert the cloth. e Verify that all gel, particulate matter, and bodily fluids have been removed. Note

Repeat Step 3 with new cleaning materials, if necessary.

To disinfect the transducer 1 Disinfect the transducer cord and body by wiping with a cloth moistened with a compatible disinfectant or premoistened disinfectant wipe. Do not get any disinfectant on the connector. 2 Disinfect the cooling slot by using a thin instrument, such as a swab, to push a disinfectant wipe into the slot

. a Pull the wipe back and forth from one side of the slot to the other. b Pull the wipe up and down from the transducer connector to the transducer head. c Remove the disinfecting wipe from the slot. d Air dry. 3 Examine the transducer and cable for damage, such as cracks or splitting where fluid can enter. If damage is evident, do not use the transducer and contact FUJIFILM SonoSite or your local representative.

Determining the required cleaning and disinfection level

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Level B: High-level disinfection (semi-critical) Clean and disinfect the transducer immediately after use. Be sure to follow the manufacturer's instructions when using cleaners and disinfectants. Refer to Table 2-3, “Compatible cleaners and disinfectants”on page 10 for a list of cleaners and disinfectants recommended for use with the transducer.

Table 2-3: Compatible cleaners and disinfectants Product

P21v transducer

Sani-Cloth AF3 (grey top) Sani-Cloth Bleach Wipes (yellow top) Sani-Cloth Plus (red top) Sani-Cloth HB (green top) T-Spray II (PI-Spray II)

Cleaning and disinfecting the transducer Use the following procedures to clean and disinfect the transducer. To clean the transducer 1 Clean the transducer cord using either a cloth dampened with cleaner or disinfectant or a premoistened disinfectant wipe. Start at the connector and wipe toward the scan head. Do not get any water or cleaner on the connector. 2 Clean all transducer surfaces using either a soft, damp, soapy cloth or disinfectant wipe. Be sure to remove any gels or particulate matter.

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Determining the required cleaning and disinfection level

3 Clean the transducer cooling slot using a thin, disposable instrument, such as a swab, to push a soft cloth lightly dampened with a cleaning solution or premoistened wipe through the slot.

a Pull the cloth back and forth from one side of the slot to the other. b Pull the cloth up and down from the transducer connector to the transducer head. c Remove the cloth from the slot. d Dispose of the cloth and the instrument used to insert the cloth. e Verify that all gel, particulate matter, and bodily fluids have been removed. Note

Repeat Step 3 with new cleaning materials, if necessary.

To high-level disinfect the transducer 1 Mix the disinfectant solution following disinfectant label instructions for solution strengths and disinfectant contact duration. Be sure to use a compatible disinfectant as listed in Table 2-7, “High-level disinfectants compatible with iViz transducers”on page 17. Caution

Use only FUJIFILM SonoSite recommended disinfectants. Using a nonrecommended 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.

Determining the required cleaning and disinfection level

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2 Immerse the transducer and about two inches of the cable in the disinfectant solution. Caution

Do not immerse the transducer connector in any liquid.

Use this diagram as a reference and then follow the instructions on the disinfectant label for the duration of the transducer immersion.

3 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, non-linting cloth. 4 Examine the transducer and cord for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use of the transducer and contact FUJIFILM SonoSite or your local representative

Table 2-4: Approved high-level disinfectants and soak times Disinfectant

Temperature

Duration

Cidex

25° C (77° F)

45 minutes

Cidex OPA

20° C (68° F)

12 minutes

Cleaning and disinfecting the transducer requires that you chose the proper cleaning and disinfecting level.

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Determining the required cleaning and disinfection level

Cleaning the iViz carry case To clean the iViz carry case, use mild soap and water, and wash it by hand or machine. You can also use one of the cleaners listed in Table 2-2, “Compatible cleaners and disinfectants”on page 7 to clean it. Using other chemicals may cause discoloration.

Storing Clean and disinfect the iViz ultrasound system prior to storing it. Store the system in a clean place with good airflow. Disconnect the transducer from the system, and hang it vertically.

Transporting When transporting the iViz ultrasound system, you must take precautions to protect the equipment from damage and avoid cross-contamination. Clean and disinfect the system by following the instructions in “Cleaning and disinfecting the system and protective case” on page 5. Be sure to transport the system in a container approved by your facility.

Disposing of the system If the iViz ultrasound system shows damage or deterioration, such as corrosion, discoloration, pitting, or cracking, do not dispose of it. Contact FUJIFILM SonoSite or your local representative.

WARNINGS

The battery inside this unit may explode if exposed to very high temperatures. Do not destroy this unit by incinerating or burning. Return the unit to FUJIFILM SonoSite or your local representative for disposal.

Cleaning the iViz carry case

13

Compatible cleaners and disinfectants (system and transducers)

P21v

Protective case

Disinfectants

iViz system

Table 2-5: Cleaners and disinfectants compatible with the iViz system and transducers

Airkem A-33 Alcohol-Ethanol Aniosyme DD1- 5% Anioxide 1000 Asepti Wipe II Baxedin Pre-Op Caviwipes Cidalkan Cidalkan Lingettes Clinell Universal Sanitising Wipes Control III Coverage Germicidal Surface Wipes Coverage Plus Germicidal Surface Wipes Coverage Spray TB DisCide Ultra Disinfecting Towlettes

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Compatible cleaners and disinfectants (system and transducers)