GE Ultrasound Probes and Accessories Reprocessing Manual

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

GE P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Healthcare Ultrasound Probes Global Engineering 1090 Route des Cretes Sophia Antipolis, WTC Batiment 6 Valbonne France

Revision History Reason for Change DATE (YYYY/MM/DD)

REV

REASON FOR CHANGE

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

List of Effective Pages

SECTION

REVISION NUMBER

SECTION

REVISION NUMBER

Title Page

Rev. 4

Chapter 1

Rev. 4

Revision History

Rev. 4

Chapter 2

Rev. 4

Regulatory Requirements

Rev. 4

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

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Ultrasound Probes and Accessories – Reprocessing Manual 5661328-1EN Rev. 4

Regulatory Requirements

Conformance Standards The following classifications are in accordance with the IEC/ EN 60601-1:6.6.2: •

According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device.

•

According to IEC/EN 60601-1, this Equipment is a sub-assembly of a device with a Class I, Type B with BF Applied Part.

•

According to CISPR 11, this system, when combined with another device, that equipment is considered Group 1, Class A ISM Equipment.

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International Electrotechnical Commission (IEC).

•

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IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

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IEC/EN 60601-1-2 Electromagnetic compatibility Requirements and tests.

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IEC 60601-1-6 (Usability), EN 1041 (Information supplied with medical devices)

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IEC 60601-2-37 Medical electrical equipment. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

International Organization of Standards (ISO) •

•

ISO 10993-1 Biological evaluation of medical devices.

Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

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Original Documentation •

The original document was written in English.

Importer Information •

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Turkey

Ultrasound Probes and Accessories – Reprocessing Manual 5661328-1EN Rev. 4

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4

Table of Contents Chapter 1 - Probe Reprocessing Procedures Probe Reprocessing Probe Care Cards- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Probe Pre-Treatment at the Point of Use (Required for All Probes) - - - - 1-3 Probe Manual Cleaning Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Probe Intermediate-Level Disinfection (ILD) - - - - - - - - - - - - - - - - - - - - 1-9 Probe High-Level Disinfection (HLD) - - - - - - - - - - - - - - - - - - - - - - - - 1-13 Chemicals Used for Efficacy Validation - - - - - - - - - - - - - - - - - - - - - - - 1-18 Covering the Transducer using a Sterile, Protective Sheath - - - - - - - - 1-19

Chapter 2 - Probe Biopsy Guide Reprocessing Procedures Probe Biopsy Reprocessing Manual Cleaning- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 High-Level Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Autoclave Sterilization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3

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Chapter 1 Probe Reprocessing Procedures ATTENTION USERS: This chapter contains information concerning Ultrasound Probe reprocessing procedures. This content supersedes all User Manual documentation for cleaning and disinfection of the non-TEE GE Ultrasound Probes. Keep this document with the User Manual and have all users become familiar with its contents. Cleaning and disinfection instructions for Transesophageal probes are documented in the Transesophageal Probe Care Card and User Manual.

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Probe Reprocessing Procedures

Probe Reprocessing

Probe Care Cards The Probe Care Card contains a list of chemicals that have been tested for compatibility with GE Ultrasound probes. The reprocessing instructions provided in this document have been validated with the chemicals specified in Table 1-3 on page 1-18. The Probe Care Card is supplied with every probe and may also be downloaded from: Table 1-1:

Documentation Website

Customer Documentation Portal Website http://www3.gehealthcare.com/en/Support/Support_Documentation_Library

Adequate cleaning and disinfection between patient cases are necessary to prevent transmission of disease. All probes must be thoroughly cleaned prior to disinfection. The level of disinfection required is based on patient contact. •

To verify probe chemical compatibility, a full list of chemicals tested is available at the GE Probe website. See the GE probe website in Table 1-2.

•

Probes that contact mucosal or non-intact skin require cleaning followed by High-Level Disinfection either soaking or use of a trophon® EPR and trophon2.

•

Probes that contact intact skin require cleaning followed by Intermediate-Level Disinfection (wipe or spray). Table 1-2:

Probe Website

Ultrasound Probe Website http://www.gehealthcare.com/transducers

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Probe Reprocessing Probe Pre-Treatment at the Point of Use (Required for All Probes) The pre-treatment step is for removal of gel and gross contamination. 1. After each use, remove protective sheath from the probe and remove the coupling gel by wiping from the strain relief to the lens with a soft, low-lint cloth. CAUTION

DO NOT use abrasive paper products when cleaning or wiping a GE Ultrasound probe. The use of abrasive wipes can damage the soft lens (acoustic window). To extend the life of the probe lens, pat dry only. 2. Wipe the cable with one of the wipes listed in the probe compatibility website from the strain relief to the connector. Wipe the cable with a low-lint cloth dampened with potable water to remove chemical residue. Dispose of the cloth, wipe and gloves in the clinical trash.

Figure 1-1. Cleaning the Probe Cable NOTE:

Use of wipes listed on the Ultrasound Probe website may result in discoloration of the cable.

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Probe Reprocessing Procedures Probe Pre-Treatment at the Point of Use (Required for All Probes) (continued) WARNING

Use caution when cleaning the connector. This cable connector should only be cleaned with a slightly dampened cloth or wipe. 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. 3. After each use, inspect the lens, cable, and housing of the probe. Look for any damage that would allow liquid to enter the probe.

DANGER

Figure 1-2.

If the probe is damaged, do not place it into any liquid (e.g. for disinfection) and do not use it until it has been inspected and repaired/replaced by a GE Service Representative.

Inspect the Lens, Cable, and Probe House After Each Use

1. Cleaning only portion 2. Cleaning only or cleaning and disinfection portion 3. Cleaning followed by appropriate level of disinfection

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Probe Reprocessing Probe Manual Cleaning Instructions Manual cleaning is required to ensure the probes are cleaned to the extent necessary for further processing. Choose the most appropriate method, either the wipe or enzymatic soak.

Cleaning with Wipes 1. Hold the probe at the proximal end near the strain relief cable. DO NOT suspend or hold the probe by the cable as this may damage the probe. 2. Dispense a cleaning wipe from the wipe canister. 3. Gently wipe the probe with a cleaning wipe from the cable strain relief to the distal end. Gently wipe the probe’s lens. NOTE:

Pay special attention to lens, edges, and groves. 4. Turn the probe and continue wiping until the entire surface of the probe has been cleaned. As the wipe becomes visibly soiled, discard the wipe into clinical trash and dispense fresh wipes as needed. 5. Wrap a clean wipe around a soft nylon bristle brush to access crevasses, such as biopsy notches, on the surface of the probe. 6. Visually inspect the probe for any remaining soil and, if necessary, repeat steps 3 through 5 until the probe is visibly clean.

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Probe Reprocessing Procedures Cleaning with Enzymatic Detergent 1. Ensure the probe has been disconnected from the console. Replace gloves and fill a sink or basin with warm potable water (30 - 40°C) to a level allowing immersion of the probe up to the immersion line shown in the user manual. 2. Prepare the cleaning solution in accordance with the detergent manufacturer’s instructions. 3. Immerse the probe in the prepared cleaning solution up to the immersion line and ensure no air bubbles are trapped on the surface. CAUTION

NOTE:

DO NOT submerge probe beyond the immersion line shown in the Ultrasound console’s user manual.

For IC5-9-D, E8C and E8C-RS, see Figure 1-9 on page 1-14 for special immersion instructions. 4. Brushing with a clean, soft, nylon bristle brush from the base of the cable strain relief to the distal tip is critical to ensure cleaning and disinfection efficacy.

Figure 1-3.

CAUTION

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Cleaning the probe using a brush

Do not use the brush on the probe lens.

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Probe Reprocessing Cleaning with Enzymatic Detergent (continued)

Figure 1-4.

Probe Lens Examples

5. Continue brushing the probe for not less than the minimum contact time listed on the detergent manufacturer’s label. 6. Visually inspect the probe for soil. Repeat Steps 3 through 5 until all visible soil has been removed from the surface of the probe. 7. Rinse the probe under running warm potable water (30 40°C) for not less than 2 minutes. Scrub the surface of the probe with a clean, soft, nylon bristle brush from the base of the cable strain relief to the distal tip. CAUTION

DO NOT use the brush on the probe lens.

8. Visually inspect the device in a well-lit area to ensure all surfaces are free from residual cleaning solution. Repeat Step 7 if visible cleaning solution is observed. 9. Thoroughly dry the probe using a clean, low-lint, soft cloth or wipe. Pat dry lens.

CAUTION

DO NOT use a twisting motion or abrasive paper products when wiping the probe as this may damage the soft lens. To extend the life of the probe lens, pat dry only.

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Probe Reprocessing Procedures Cable and Connector Manual Cleaning

CAUTION

Use caution when cleaning the connector. This cable connector should only be cleaned with a slightly dampened cloth or wipe. 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. 1. The cable and connector surfaces can be cleaned with the cleaners or wipes listed in the Probe Care Card.

NOTE:

Use of wipes listed on the Ultrasound Probe website may result in discoloration of the cable. 2. Wipe the cable with a low-lint cloth dampened with potable water to remove chemical residue.

Figure 1-5.

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Cleaning the Probe Cable

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Probe Reprocessing Probe Intermediate-Level Disinfection (ILD) For Intermediate-Level Disinfection of intact skin contacting probes, choose either the spray or wipe method. NOTE:

Probes that contact only intact skin may be disinfected in this manner. All probes that contact non-intact skin or mucous membranes (e.g., endocavitary, Transesophageal) require High-Level Disinfection.

CAUTION

After each use, inspect the lens, cable, and housing of the probe. Look for any damage that would allow liquid to enter the probe.

DANGER

If the probe is damaged, DO NOT place it into any liquid (e.g. for disinfection) and DO NOT USE until the probe has been inspected and repaired/replaced by a GE Service Representative.

Probe ILD - Disinfectant Spray 1. Put on a new pair of gloves and spray enough disinfectant solution to saturate a new disposable low-lint wipe or cloth. 2. Holding the probe near the strain relief, apply the dampened cloth to the patient contacting lens. Wipe the probe from the lens to the strain relief, slightly rotating the probe after each wiping pass.

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Probe Reprocessing Procedures Probe ILD - Disinfectant Spray (continued) 3. After the probe has been completely wiped, dampen a second wipe with disinfectant and starting at the probe lens begin wiping the probe in a rotating motion moving down towards the strain relief. Spray disinfectant directly on the recessed areas and ridges to saturate.

Figure 1-6.

Disinfecting the Probe Moving from Lens to Strain Relief

4. Once the probe has been completely wiped, dampen a third wipe with disinfectant and continue wiping the probe as needed to ensure the surface remains wet for the required exposure time. Use as many wipes as needed and re-spray disinfectant on recessed areas and ridges, to ensure all surfaces remain wet for the minimum required contact time listed in the disinfectant manufacturer’s instructions for use. 5. Thoroughly dry all surfaces of the probe using a soft, low-lint wipe or cloth, changing wipes/cloths when necessary to ensure the probe is completely dry. Pat dry lens. Visually inspect the probe to ensure all surfaces are dry. Repeat drying steps if any moisture is visible. 6. If the probe is not immediately reused, store the probe in a manner that will protect and keep the probe from being recontaminated. This may be accomplished by placing the probe in a storage cabinet with filtered air flow and/or by using a disposable storage cover placed over the probe.

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Probe Reprocessing Probe ILD - Disinfectant Wipe 1. Replace gloves. Holding the probe near the strain relief, apply the wipe to the patient contacting lens. Wipe the probe from the lens to the strain relief, slightly rotating the probe after each wiping pass. 2. After the probe has been completely wiped, use a second wipe and starting at the probe lens begin wiping the probe in a rotating motion moving down towards the strain relief. Wring the wipe above recessed areas, seams, and ridges to drip disinfectant directly onto these less accessible surfaces.

Figure 1-7. NOTE:

Disinfecting the Probe Moving from Lens to Strain Relief

Probes that contact only intact skin may be disinfected in this manner. All probes that contact mucous membranes (e.g., endocavitary, Transesophageal) require High-Level Disinfection.

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Probe Reprocessing Procedures Probe ILD - Disinfectant Wipe (continued) 3. Once the probe has been completely wiped, use a third wipe and continue wiping the probe as needed to ensure the surface remains wet for the required exposure time. Use as many wipes as needed and drip additional disinfectant on recessed areas and ridges, to ensure all surfaces remain wet for the minimum required contact time listed in the disinfectant manufacturer’s instructions for use.

Figure 1-8.

Disinfecting the Probe

4. Thoroughly dry all surfaces of the probe using a soft, low-lint wipe or cloth, changing wipes/cloths when necessary to ensure the probe is completely dry. Pat dry lens. Visually inspect the probe to ensure all surfaces are dry. Repeat drying steps if any moisture is visible. 5. If the probe is not immediately reused, store the probe in a manner that will protect and keep the probe from being recontaminated. This may be accomplished by placing the probe in a storage cabinet with filtered air flow and/or by using a disposable storage cover placed over the probe.

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