Ultrasound Probes and Accessories Reprocessing Manual

Regulatory Requirement This manual is a reference for Ultrasound Probes and Accessories. Conformance Standards •

International Organization of Standards (ISO) •

•

ISO 17664-1 and -2:2021

Food and Drug Administration. 2015/(R)2017. Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

Original Documentation The original document was written in English.

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Revision History Table -1 • Reason for Change Revision

Date

Reason for change

(YYYY/MM/DD) Rev. 1

2017/08/28

Initial Release

Rev. 2

2017/12/26

Update

Rev. 3

2018/11/02

Update

Rev. 4

2019/07/19

Update to existing content and to add Accessories

Rev. 5

2023/07/20

Update entire document to existing content

Please verify that you are using the latest revision of this document by accessing the Customer Documentation Portal website, referenced in Table 2-4 • Customer Portal on page 8 or contact your distributor, local GE HealthCare Sales Representative or in the USA call the GE HealthCare Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.

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Table of Contents Chapter 1 - Symbols

Chapter 2 - Probe Processing Procedures ATTENTION USERS... 6 Probe Processing... 7 Probe Care Cards and Website... 9 Probe Pre-Treatment at the Point of Use...10 Preparation before Cleaning...11 Probe Manual Cleaning... 12 Cleaning with Wipes... 12 Cleaning with Enzymatic Detergent... 12 Cable and Connector Cleaning/Disinfection... 16 Probe Intermediate-Level Disinfection (ILD)... 18 Probe ILD - Disinfectant Spray or Wipe... 18 Probe High-Level Disinfection (HLD)... 20 Probe HLD – Soak... 20 Probe HLD – Tristel Trio and Tristel Duo ULT... 23 Probe HLD - trophon® EPR and trophon®2...24 Reassembly of probes... 25 Covering the Transducer using a Protective Sheath... 27

Chapter 3 - Probe Transportation, Storage, Inspection and Disposal Probe Transportation... 30 Probe Storage...31 Probe inspection... 32

Chapter 4 - Reusable Probe Biopsy Guide Processing Procedures Probe Biopsy Processing... 34 Manual Cleaning...35

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Table of Contents

High-Level Disinfection...36 Autoclave Sterilization... 37

Chapter 5 - CE Mark CE Mark... 40

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Chapter 1 Symbols

Symbol

XXXX

Meaning

Standard

Signifies a general warning

ISO 7010-W001

Consult accompanying documents. This symbol advises the user to consult the accompanying documents.

ISO 7010-M002

Describes precautions necessary to prevent the risk of injury through electric hazards. Warning, electricity

ISO 7010-W012

Describes precautions necessary to prevent the risk of disease transmission or infections.

ISO 7010-W009

Manufacturer name and address

ISO 7000-3082

Indicates that the product is in N/A- by certification body compliance with all relevant European Directives and under surveillance by Notified Body XXXX Symbol indicates useful information

N/A- by GE HealthCare

Use care when handling ultrasound probes and protect the probe head from damage.

N/A- by GE HealthCare

Do not immerse the probe into any liquid beyond the level specified for that probe. Refer to the Instructions for Use of the ultrasound system.

N/A- by GE HealthCare

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Symbols

Symbol

Meaning

Standard

This is to illustrate compatible N/A- by GE HealthCare cleaners or disinfectants available in wipes format (to be used according to instruction from the manufacturers of these products) This is to illustrate compatible N/A- by GE HealthCare cleaners or disinfectants available in liquid format (to be used according to instruction from the manufacturers of these products) This is to illustrate compatible ultrasound coupling gels

N/A- by GE HealthCare

This is to illustrate compatible N/A- by GE HealthCare cleaners or disinfectants available in spray format (to be used according to instruction from the manufacturers of these products)

4

This is to illustrate compatible cleaners or disinfectants available in powder (to be used according to instruction from the manufacturers of these products)

N/A- by GE HealthCare

This is to illustrate compatible automated reprocessors (to be used according to instruction from the manufacturers of these products)

N/A- by GE HealthCare

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Chapter 2 Probe Processing Procedures

In this section

ATTENTION USERS... 6 Probe Processing...7 Probe Care Cards and Website...9 Probe Pre-Treatment at the Point of Use... 10 Preparation before Cleaning... 11 Probe Manual Cleaning... 12 Probe Intermediate-Level Disinfection (ILD)... 18 Probe High-Level Disinfection (HLD)...20 Reassembly of probes... 25 Covering the Transducer using a Protective Sheath...27

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Probe Processing Procedures

ATTENTION USERS This chapter contains information concerning cleaning and disinfection of the nonTEE GE HealthCare Ultrasound Probes. The following sections are written for users who are familiar with processing techniques. Refer to the Console User Manual for information on the probe. Cleaning and disinfection instructions for Transesophageal (TEE) probes are documented in the Transesophageal Probe Care Card and System User Manual.

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Chapter 2

Probe Processing To prevent transmission of disease, adequate cleaning and disinfection are necessary before first use, between patient use, and every time the probe is stored or transported in a nonclean container like shipping case. All probes must be thoroughly cleaned prior to disinfection. The required level of disinfection is based on the type of tissue the probe will contact during use. These recommendations suit the Spaulding classification for intended use, and federal guidelines from FDA1 and CDC2 for proper processing of reusable medical instruments. Refer to Table 2-1 • Care Methods by type of tissue on page 7. Table 2-1 • Care Methods by type of tissue Type of tissue

Care Method

Intact skin only

Cleaning followed by Intermediate-Level Disinfection (ILD) (wipe or spray)

Mucosal or Non-intact skin

Cleaning followed by High-Level Disinfection (HLD) (soaking or wipe or use of a trophon® EPR or trophon®2)

NOTE According to FDA Guidance and CDC Guideline, ILD have HBV, HIV, and tuberculocidal claims. HLD refer to FDA-cleared high-level disinfectants. NOTE There are no adequate means to disinfect a probe that has been contaminated by prions, such as Creutzfeldt Jacob’s disease. In this case, the contaminated probe MUST BE discarded in accordance with local biologic waste hazard procedures. The following picture indicates the appropriate care method of the different portions of the probe. Table 2-2 • Care Methods by Probe Area Probe

Care Method

Connector (1)

Cleaning only

Cable (2)

Processed using cleaning/ disinfectant wipes

Probe (3)

Cleaning followed by appropriate level of disinfection

Picture

The processing instructions provided in this document have been validated per ISO 17664: 2021 to properly prepare GE HealthCare Ultrasound probes for re-use, with the chemicals mentioned in Table 2-3 • Products with validated efficacy performed by GE HealthCare on page 8. It remains the responsibility of the processor to ensure that the processing is 1

FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 17 2015 2 CDC – Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

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Probe Processing Procedures

performed as specified in this document. This may require verification and routine monitoring of the process. Table 2-3 • Products with validated efficacy performed by GE HealthCare Product Type

Trade Name

Manufacturer

Minimum Contact Active Ingredient Time

Cleaning (Wipe)

Oxivir® Tb

Diversey

N/A

Hydrogen Peroxide

Enzol® (Cidezyme®)

Advanced Sterilization Products® (J&J)

1-Minute

Proteolytic Enzymes

MetriZyme™

Metrex™

Prolystica® 2X

Steris

Cleaning (Soak)

Soak

Concentrate Presoak & Cleaner Intermediate-level

Oxivir® Tb

Diversey

Disinfectant (wipe or liquid)

Hydrogen Peroxide

Exposure

Intermediate-level Sani-Cloth AF3 Disinfectant (wipe)*

PDI

Cidex® OPA (FDA- Advanced cleared) Sterilization Disinfectant (Soak) Products (J&J) High-level

High-level Disinfectant (wipe)**

10-Minute

3-Minute Exposure Quaternary ammonium 12-Minute Soak

Orthophthalaldehyde

McKesson OPA/28 McKesson

10-minute soak

Tristel Trio

1-minute Exposure Chlorine dioxide

Tristel

Tristel Duo ULT

* For 12S series and 6S series, Sani-Cloth AF3 is validated ** Tristel Trio and Tristel Duo ULT are validated only for RIC5-9A-RS, RIC5-9-D, RIC5-9W-RS and RIC6-12-D probes

To download the latest revision of the probes processing manual, visit the Customer Documentation Portal and type reference 5661328 in the search bar. Table 2-4 • Customer Portal Customer Documentation Portal https://www.gehealthcare.com/documentation

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Chapter 2

Probe Care Cards and Website The Care Card, supplied with every probe, contains a list of additional processing products that are compatible with probe materials, but GE HealthCare has not validated their efficacy. When using these products, refer to their manufacturer’s instructions for use. A complete list of compatible products is also available on the Ultrasound Probes website. This list updates periodically with new products and probes. (Refer to Table 2-5 • Documentation Website on page 9). Table 2-5 • Documentation Website Ultrasound Probes Website https://www.gehealthcare.com/transducers

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Probe Processing Procedures

Probe Pre-Treatment at the Point of Use The pre-treatment step is for removal of the protective sheath, if used, the gel and gross contamination. After each use, remove protective sheath, if used, from the probe and remove the coupling gel by wiping from the cable strain relief to the acoustic lens end (i.e. from cleanest to dirtiest area), with a soft, low-/non-linting cloth or cleaning wipe. CAUTION USE non-abrasive cloth or wipe, such as Kimwipes™ Delicate Task Wipers or equivalent. DO NOT use a twisting motion when wiping the probe. To extend the life of the probe acoustic lens, pat dry only.

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Chapter 2

Preparation before Cleaning Some probes need to be disassembled before cleaning and disinfection. Either follow the disassembly instructions mentioned in your ultrasound system user manual or pictures below. E7C8L-RS

P2D/P2D-RSe

P6D/P6D-RS

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Probe Processing Procedures

Probe Manual Cleaning Thorough cleaning is a mandatory first step to allow adequate subsequent disinfection or sterilization. Choose the most convenient method, either the wipe or enzymatic soak. WARNING DO NOT clean the probe in an automated washer-disinfector, due to the possible damage of the connector/console interface. Use necessary precautions (e.g. gloves, face screen and gown), as directed by your facility.

Cleaning with Wipes 1. 2. 3.

Hold the probe by the handle near the cable strain relief. DO NOT suspend or hold the probe by the cable as this may damage the probe. Dispense a cleaning wipe from the wipe canister. Gently wipe the probe with a cleaning wipe from the cable strain relief to the acoustic lens (i.e. from cleanest to dirtiest area). Gently wipe the probe’s acoustic lens. NOTE Pay special attention to acoustic lens, edges, and crevices, removing all gel, product, and body fluids.

4.

5.

Turn the probe and continue wiping until the entire surface of the probe has been wiped. As the wipe becomes visibly soiled, discard the wipe into clinical trash and dispense fresh wipes as needed. As needed for additional focused cleaning to crevices, wrap a clean wipe around a soft nylon bristle brush or other suitable instrument to access crevices, such as biopsy notches. Visually inspect the probe for any remaining soil and, if necessary, repeat steps 3 and 4 until the probe is visibly clean. NOTE

6.

Clean the probe holder of the ultrasound system before returning the probe back to the system (refer to the probe holder cleaning instruction in the ultrasound system user manual for details). Thoroughly dry the probe using a clean, low-/non-linting, soft cloth or wipe. Pat dry acoustic lens.

Cleaning with Enzymatic Detergent 1.

Ensure the probe has been disconnected from the console. Use necessary precautions (e.g. gloves, face screen and gown), as directed by your facility. Fill a sink or basin with warm utility water (30 - 40°C) to a level allowing immersion of the probe up to the immersion line.

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Chapter 2

Example of a probe immersion diagram is shown in Figure 2-1 • Examples of Probe Immersion levels on page 13 below. Refer to the specific immersion diagram in your ultrasound system user manual.

1

Fluid level

Figure 2-1 • Examples of Probe Immersion levels 2. 3.

Prepare the cleaning solution in accordance with the detergent manufacturer’s instructions. Immerse the probe in the prepared cleaning solution, for the minimum contact time mentioned in Table 2-3 • Products with validated efficacy performed by GE HealthCare on page 8, and up to the immersion line. Ensure no air bubbles are trapped on the probe's surface. CAUTION DO NOT submerge probe beyond the immersion line shown in the System user manual.

NOTE Over-exposing ultrasound probes to cleaning solution may damage the ultrasound probe. NOTE For IC5-9-D, E8C, and E8C-RS probes with serial numbers listed below or greater, refer to Figure 2-2 • Probe Immersion Level for IC5-9-D, E8C, and E8CRS with serial numbers listed above on page 14 for the soaking level: • • •

IC5-9-D: 780333WX1 or greater (example 780334WX1, 780335WX1) E8C: 783101WX9 or greater (example: 783102WX9, 783103WX9) E8C-RS: 782439WX4 or greater (example 782440WX4, 782441WX4)

The prefix number, i.e. 780333 for 780333WX1, indicates serial number sequence.

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Probe Processing Procedures

1

Serial number location

Figure 2-2 • Probe Immersion Level for IC5-9-D, E8C, and E8C-RS with serial numbers listed above 4.

While immersed in the cleaning solution, brush with a clean, soft, nylon bristle brush. Maintain the immersion level while brushing. This step is critical to ensure cleaning efficacy. CAUTION Do not use the brush on the acoustic lens.

Figure 2-3 • Cleaning the probe using a brush 5. 6.

Visually inspect the probe for soil. Repeat Steps 3 and 4 until all visible soil has been removed from the surface of the probe. Rinse the probe under running warm utility water (30 - 40°C) for not less than 2 minutes, while scrubbing the surface of the probe with a clean, soft, nylon bristle brush from the base of the cable strain relief to the acoustic lens. CAUTION DO NOT use the brush on the acoustic lens.

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Chapter 2

NOTE Discard solutions and rinse waters in accordance with local regulations. 7. 8.

Visually inspect the device in a well-lit area to ensure all surfaces are free from residual cleaning solution. Repeat Step 6 if visible cleaning solution is observed. Thoroughly dry the probe using a clean, low-/non-linting, soft cloth or wipe. Pat dry acoustic lens. CAUTION USE non-abrasive cloth or wipe, such as Kimwipes™ Delicate Task Wipers or equivalent. DO NOT use a twisting motion when wiping the probe. To extend the life of the probe acoustic lens, pat dry only. NOTE Clean the probe holder of the ultrasound system before returning the probe back to the system (refer to the probe holder cleaning instruction in the ultrasound system user manual for details).

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Probe Processing Procedures

Cable and Connector Cleaning/Disinfection The connector can be cleaned with a wipe dampened with alcohol. Use caution when cleaning the connector, wring wipe to remove excess of liquid before wiping the connector. Prevent introduction of foreign objects in the system connector assembly. Do not apply excessive force on any component of the system connector. WARNING Exposure to excessive moisture will result in damage to the probe and possibly the ultrasound console. DO NOT wet the connector/console interface surface or labels (Refer to red circles in picture below). DO NOT clean the probe in an automated washer-disinfector.

The cable should be processed using cleaning/disinfectant wipes. If the cable has been in contact with risk factors, such as blood and/or mucous, cleaning should be followed by disinfection. 1. 2.

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Dispense a cleaning/disinfectant wipe from the wipe canister Wipe the cable with a cleaning/disinfectant wipe from the handle strain relief to the connector strain relief (refer to Figure 2-4 • Cleaning the Probe Cable on page 17). As the wipe becomes visibly soiled, discard the wipe into clinical trash and dispense fresh wipes as needed

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