Vivid E and S Series Cleaning and Disinfection Guide Rev 01

Revision History Reason for change

REV Rev. 01

DATE (YYYY-MM-DD) 2022-09-05

REASON FOR CHANGE Initial version

List of Effective Pages PAGE NUMBER All pages

REV Rev. 01

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE electronic Product Data Management). If you need to know the latest revision, 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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Chapter 1 Cleaning and Disinfection Guide

This is an addendum to the User Manuals for Vivid E95 / E90 / E80 / S70N / S60N / S70 / S60 / E9.

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Cleaning and Disinfection Guide

Cleaning and Disinfection Guide

Cleaning and Disinfection schedule Follow this Cleaning and Disinfection schedule to maintain optimum system function and patient care:

Table 1-1:

Cleaning and Disinfection schedule

After each patient

Bi-weekly

Clean and disinfect the following parts after each patient:

Clean the following on a bi-weekly basis: •

Storage bins (Vivid E95 / E90 / E80)

•

Probe (see Chapter ‘Probes’ in the User Manual)

•

Rear storage bin (Vivid S70N / S60N / S70 / S60)

•

ECG leads and cable

•

•

Biopsy Brackets, as applicable

Front cover incl. probe connector panels

•

Monitor screen, monitor frame and touch panel

•

Side covers with optional B/W printer and DVD drive

•

Operator panel with buttons, rotaries and trackball

•

Top and side covers (Vivid E95 / E90 / E80)

•

Probe and gel holders

•

•

Front handles with up/down and front panel lock/unlock buttons, and palm rest (Vivid E95 / E90 / E80)

Top cover of bottom part (Vivid S70N / S60N / S70 / S60)

•

System rear side, incl. monitor arm, rear handle and other areas that do not come in direct or indirect contact with the patient

•

Casters and caster covers/foot rest (Vivid S70N / S60N / S70 / S60)

•

Front handle (Vivid S70N / S60N / S70 / S60)

•

Cable hooks

•

Probe cable storage bin (Vivid S70N / S60N / S70 / S60)

•

Alphanumeric keyboard (optional, if used (Vivid S70N / S60N / S70 / S60))

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Cleaning and Disinfection Guide Cleaning and disinfecting the system The below listed cleaners/disinfectants in Table 1-2 on page 1-4 can be used for cleaning and disinfection of the identified parts in the table. Cleaning and disinfection of probes, ECG leads, ECG cables and biopsy brackets are described elsewhere: •

Probes: Refer to Chapter ‘Probes’ in the User Manual.

•

ECG leads and cables: Refer to Instructions for use (IFU 2107129-001 and IFU 2107121-001) for ECG leads and ECG cables respectively. IFUs are included with the packaging of the ECG leads/cables.

•

Reusable non-sterile biopsy brackets: Refer to Instructions for use (IFU) for the respective biopsy kits and brackets from Civco, the manufacturer: https://www.civco.com/catalog/ ultrasound-needle-guides/ ultra-pro-2-ultrasound-needle-guides-multi-angle/. IFUs are also included with the packaging.

Always consult the cleaner or disinfectant manufacturer’s instructions for proper use of their product. Wear appropriate PPE as indicated by the manufacturer. Appropriate cleaners/ disinfectants for the console that have been validated for compatibility are shown below:

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Cleaning and Disinfection Guide

Table 1-2:

Appropriate Cleaners/Disinfectants Main monitor and touch panel screens (glass)

Monitor and surrounding enclosure (Vivid E95 / E90 / E80 / E9)

Monitor and surrounding enclosure (Vivid S70N / S60N / S70 / S60)

Operator Panel and keyboard

Phono and pressure adapters, footswitch (Vivid E95 / E90 / E80 / E9)

System console, probe and gel holders, front handle, cable hooks

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Manufacturer Cleaning agents Mild, Non-Abrasive Soap and Water

Generic

Ammonia (2:1 Ratio of max 10% Home Ammonia)

Generic

Low level disinfection agents Bleach (10:1 Ratio of 5% Home Bleach)

Generic

x

Hydrogen Peroxide / Hydrogen Peroxide Wipes

Clorox

x

T-Spray IITM Disinfectant Cleaner

Pharmaceutical Innovations

x

Sani-Cloth HB® Germicida

PDI

x

CIDEX OPA

ASP

x

Diluted Cidex® (Activated Dialdehyde Solution)

ASP

x

Metrex MetricideTM 14

Bowers

x

Waviside-01

Medical Chemical Corporation

x

Isopropyl Alcohol (70%) (Generic)

Generic

NOTE:

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x

x

x

x

x

x

x

When new cleaners and disinfectants are determined to be compatible with ultrasound systems materials, they are added to this website: https://cleaning.gehealthcare.com.

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Cleaning and Disinfection Guide NOTE:

Effective cleaning and disinfection of parts with narrow gaps and holes (e.g. keyboard, trackball) may be difficult.

NOTE:

To identify the various parts in the table, see figures below.

DANGER

1. 2. 3. 4. 5.

System surfaces and transducers are resistant to ultrasound gel, alcohol, and disinfectants, but if used, wipe them off to prevent permanent damage.

Monitor frame Monitor screen Touch panel screen Operator panel Probe holders (both sides if used)

6. 7. 8. 9.

Front handle and palm rest Cable hooks (both sides if used Alphanumeric keyboard (if used) Monitor frame and rear panel

Figure 1-1. Vivid E95 / E90 / E80 / E9. Parts requiring cleaning and low-level disinfection after each patient according to the Cleaning and Disinfection schedule. (See Table 1-1 on page 1-2 for details.)

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Cleaning and Disinfection Guide

1. 2. 3. 4. 5.

Monitor frame Monitor screen Touch panel screen Operator panel Probe holders (both sides if used)

6. Cable hooks (both sides if used) 7. Alphanumeric keyboard (option) below operator panel 8. Front handle 9. Probe cable storage bin 10. Monitor frame and rear panel

Figure 1-2. Vivid S70N / S60N / S70 / S60. Parts requiring cleaning and low-level disinfection after each patient according to the Cleaning and Disinfection schedule. (See Table 1-1 on page 1-2 for details.)

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Cleaning and Disinfection Guide

1. Console top cover 2. Storage bins, enclosure and speaker grilles (both sides) 3. Top cover, bottom console part 4. Side covers (both sides) 5. Front cover, incl. probe connector panels, B/W printer, DVD drive 6. Foot rest and brake pedals 7. Bottom covers, front, sides and back 8. Casters, both sides, front and rear

Figure 1-3.

9. Pressure and microphone adapters 10. Monitor arm 11. Rear storage shelf (not Vivid E9) 12. Rear handle 13. Rear storage bin (not Vivid E9) 14. Rear cover, incl. rear panel, air inlet grille and cable hooks 15. Fan filter module 16. Footswitch

Vivid E95 / E90 / E80 / E9. Parts requiring cleaning only according to the Cleaning and Disinfection schedule. (See Table 1-1 on page 1-2 for details.)

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Cleaning and Disinfection Guide

1. 2. 3. 4. 5.

Monitor arm Rear handle Rear storage bin Top cover, bottom console part Side covers

Figure 1-4.

6. Front cover, incl. probe connector panels 7. Bottom caster covers/foot rest 8. Casters, both sides, front and rear 9. B/W printer and DVD player (both optional) 10. Rear cover, incl. rear panel and air inlet grille

Vivid S70N / S60N / S70 / S60. Parts requiring cleaning only according to the Cleaning and Disinfection schedule. (See Table 1-1 on page 1-2 for details.)

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Cleaning and Disinfection Guide Cautions When performing cleaning and disinfection procedures, to prevent the risk of system damage, always observe the following precautions:

WARNING

Prior to cleaning and disinfection, turn OFF power to the system and disconnect the mains cable.

WARNING

•

Do not spray any liquid directly onto the covers, displays, or keyboard.

•

Do not allow any liquid to drip or seep into the system.

•

DO NOT scratch or press on the panel with any sharp objects, such as pencils or pens, as this may result in damage to the panel.

•

Make sure not to spill or spray any liquid on the controls, into the system cabinet, or in the probe connection receptacle.

DANGER

Never use thinner, benzene, ethanol or methanol alcohol, abrasive cleaners, or other strong solvents, as these may cause damage to the cabinet or display panels. Only use isopropyl alcohol, when instructed to do so.

WARNING

Follow the disinfectant manufacturer recommendations.

DANGER

System surfaces and transducers are resistant to ultrasound gel, alcohol, and disinfectants, but if used, wipe them off to prevent permanent damage.

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Cleaning and Disinfection Guide Cleaning and disinfection procedures NOTE:

The following procedures describe cleaning of the complete ultrasound system, and low-level disinfection of certain parts of the ultrasound system. Prior to cleaning and disinfection of any part of the system turn off the power. If possible, disconnect the power cord. Always clean visible soil from surfaces first before disinfection. Follow the cleaning/disinfection frequency suggested in the ‘Cleaning and Disinfection Schedule’ in Table 1-1 on page 1-2.

Cleaning only instructions All parts listed on Figure 1-3 on page 1-7 or Figure 1-4 on page 1-8 shall be cleaned using these instructions. These parts require cleaning only, not disinfection. To clean the part: 1. Moisten a soft, non-abrasive folded non-linting cloth with a mild, general purpose, non-abrasive soap and water solution or approved cleaning/disinfection agent. Approved wipes can also be used. NOTE:

The non-linting cloth/wipe should be damp, not dripping wet and running. Moisture should not drip into the crevices anywhere on the console.

NOTE:

Refer to Table 1-2 on page 1-4 for a list of acceptable cleaning agents to be used with the various parts. 2. Use a gentle wiping action to clean any surface on the console.

NOTE:

A scrubbing action with the wipe may be necessary to help remove stubborn soil from the surfaces. However, be careful with this action over crevices and gaps in the surface to prevent liquid from being scraped off the wipe and entering the product. 3. Clean until visually clean. 4. Wipe off excess cleaning agents.

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NOTE:

Do not spray any liquid directly into the unit.

NOTE:

DO NOT scratch or press on the panel with any sharp objects, such as pencils or pens, as this may result in damage to the panel.

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Cleaning and Disinfection Guide Combined cleaning and disinfection instructions Parts listed on Figure 1-1 on page 1-5 or Figure 1-2 on page 1-6 must be both cleaned and disinfected as described below, in order to prevent crosscontamination. Refer to Table 1-2 on page 1-4 for which cleaning and disinfection agents to use with which part. Table 1-3: Step C1

Cleaning steps Cleaning instructions

Moisten a soft, non-abrasive folded non-linting cloth with a mild, general purpose, non-abrasive soap and water solution or approved cleaning/disinfecting agent. Approved wipes can also be used. NOTE: The non-linting cloth/wipe should be damp, not dripping wet and running. Moisture should not drip into the crevices anywhere on the console. Refer to Table 1-2 on page 1-4 for a list of acceptable cleaning agents to be used with the various parts.

C2

Use a gentle wiping action to clean any surface on the console part or accessory as described in detail below. NOTE: A scrubbing action with the wipe may be necessary to help remove stubborn soil from the surfaces. However, be careful with this action over crevices and gaps in the surface to prevent liquid from being scraped off the wipe and entering the product.

C3

Main display frame and rear panel

Main display screen and Touch panel glass

Operator control panel and keyboard

Probe (and gel) holders

Front handle, cable hooks, palm rest (Vivid E95 / E90 / E80), probe cable storage bin (Vivid S70N / S60N / S70 / S60)

Gently wipe down the top, front, back, and both sides of the display frame. Do not spray any liquid directly onto the screen.

Gently wipe the surface of the main display and Touch panel.

Gently wipe the surface of the Control panel and the keycaps. Use a cotton swab to clean around keys or controls. Use a toothpick to remove solids from between keys and controls.

Gently wipe the probe holder surface to remove all traces of gel. If probe or gel-cup inserts are used, remove these and clean them separately.

Gently wipe the surface of the handle, the buttons on the sides, as well as the cable hooks underneath the operator panel.

C4

Clean until visually clean.

C5

Wipe off excess cleaning agent and allow to dry.

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Cleaning and Disinfection Guide Table 1-4: Step D1

Disinfection steps Disinfection instructions

Moisten a non-linting cloth with a liquid disinfectant or remove a pre-moistened disinfectant wipe from the container. CAUTION: If a cleaner/disinfectant wipe was used to clean off visible soil per the above cleaning section, a second, fresh cleaner/disinfectant wipe should be used for the disinfectant step.

D2

Wet the surfaces by applying disinfection agent with the non-linting cloth or wipe. See special instructions for each part below in step D5. Avoid high pressure or squeezing the wipe to avoid having the liquid enter the gaps and crevices of the part. Scrubbing is not necessary in the disinfection step; evenly applying the liquid is the goal.

D3

Let the surface remain wet for the appropriate contact time as per the disinfectant manufacturer instructions.

D4

Apply an additional application of the disinfectant, as necessary, to extend the time, if the surface does not remain wet for the full contact time.

D5

Main display frame and rear panel

Main display screen and Touch panel glass

Operator control panel and keyboard (except trackball)

Probe (and gel) holders

Front handle, cable hooks, palm rest (Vivid E95 / E90 / E80), probe cable storage bin (Vivid S70N / S60N / S70 / S60)

Gently apply disinfectant to the top, front, back, and both sides of the display frame. Do not spray any liquid directly onto the screen.

Gently apply disinfectant to the surface of the Main display and Touch panel.

Gently apply disinfectant to the surface of the Control panel and the keycaps. Use a cotton swab with disinfectant around keys or controls.

Gently apply disinfectant to the probe holders. If probe or gel-cup inserts are used, remove these and apply disinfectant to them separately.

Gently apply disinfectant to the surface of the handle, the buttons on the sides, as well as the cable hooks underneath the operator panel.

D6

Remove excess liquid with a dry non-linting cloth after the contact time has expired.

D7

Perform a rinse step with a non-linting damp (using critical (or treated) water) cloth, if necessary, to avoid disinfectant buildup, or to remove disinfectant residue which may cause skin irritation.

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Cleaning and Disinfection Guide To clean and disinfect the trackball: 1. To disassemble the trackball, rotate the top locking ring counter-clockwise around the trackball and lift off the top locking ring and the trackball from the Control panel (1-3 in the figure below). 2. Apply an approved cleaning agent (see Table 1-2 on page 1-4) to a soft, non-abrasive, non-linting cloth. The cloth should be damp, not dripping wet. Wipe the trackball, the ring and the trackball housing with this cloth (4-6). If needed for access, use a cotton swap applied with the same agent. Wipe excess agent and allow to dry. 3. Use an approved disinfection wipe or apply a disinfection agent to a new non-linting cloth. Use this wipe/cloth and repeat step 2 above. 4. Let the surface remain wet for the appropriate contact time as per the disinfectant manufacturer instructions. If the surface does not remain wet for the full contact time, apply an additional application of the disinfectant, as necessary, to extend the time. 5. Wipe off any disinfectant residue with a dry non-linting cloth and/or cotton swab. 6. To avoid disinfectant buildup, or to remove disinfectant residue which may cause skin irritation, perform a rinse step with a non-linting damp cloth (using critical (or treated) water). 7. Insert the trackball into the housing, then insert the locking ring and rotate it clockwise to lock it in position (7-9).

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Cleaning and Disinfection Guide Vivid E95 / E90 / E80 / E9

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Cleaning and Disinfection Guide Vivid S70N / S60N / S70 / S60

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Cleaning and Disinfection Guide

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