CARESCAPE V100 Vital Signs Monitor Cleaning and Disinfection Supplement 1st edition

Cleaning and Disinfection Supplement

Contents

Contents Legal manufacturer ...5 Manufacturer information ... 5

Important information ...7 About cleaning and disinfection ... 7 About these instructions ... 7 Visual inspection before cleaning and disinfection ... 7 Cleaning and disinfection frequency... 7 Safety precautions... 8 Cleaning warnings... 8 Cleaning cautions... 9 Disinfection notices... 9 Cleaning points to note... 9 Disinfection points to note... 10 Supplies needed for cleaning and disinfection...10 Permitted cleaning and disinfection agents...11

How to clean and disinfect ... 13 Cleaning during patient monitoring ...13 Cleaning and disinfection between patients ...13 Cleaning and disinfecting the monitor between patients...13

Other information ... 23 Additional information... 23 How to store devices ... 23

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Legal manufacturer Manufacturer information CARESCAPE V100

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA

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Important information About cleaning and disinfection • Cleaning is physical removal of soil and contaminants. • Disinfection reduces the number of viable microorganisms on a product to a level previously specified as appropriate for its use.

About these instructions The following cleaning and disinfection information applies to the devices and device components listed in this supplement and manufactured by GE. The information in this supplement supersedes any cleaning and disinfection instructions given in the device manuals. Follow these instructions to clean and disinfect the monitor and other parts that are not in direct contact with the patient, referred to as non-applied parts, unless there are separate part-specific instructions. For details about cleaning, disinfecting and sterilizing accessories, see the instructions for use in the accessory package. For cleaning, disinfection, and care information for devices, device components, supplies, and accessories made by manufacturers other than GE, see the applicable instructions for use provided by the manufacturer. The information provided in this supplement does not supersede any instructions for use provided by the manufacturer or provided with a device, device component, supply, or accessory. In these instructions, the term monitor refers to the CARESCAPE V100.

Visual inspection before cleaning and disinfection Carefully inspect devices visually to verify proper function. Do not use improperly functioning, damaged, or excessively worn devices, or devices with unrecognizable markings or missing or worn device labeling or marking. Evidence of damage and wear on a device may include but is not limited to discoloration, excessive scratches, melting, dulling, distortion, wear, and cracks. If a device is extremely soiled and cannot be cleaned using the normal procedure, replace it. Contact qualified service personnel and follow your professional healthcare facility procedures. If you discover any signs of deterioration or damage in the device, discontinue its use.

Cleaning and disinfection frequency The following table indicates the frequency of visual inspection, cleaning, and disinfection procedures.

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Safety precautions

Cleaning and Disinfection Supplement

Device Monitor:

Visual inspection

Cleaning

Disinfection

• Before and after each patient use

• After each patient use

• After each patient use

• Before and after cleaning or disinfection

• Perform disinfection after cleaning, not before

Safety precautions Cleaning warnings WARNING EQUIPMENT DAMAGE Avoid using other chemicals than the ones described in this manual as they may damage device surfaces, labels, or cause equipment failures. WARNING EQUIPMENT DAMAGE Never use conductive solutions, oxidizing compounds, wax, or wax compounds to clean the device, cables, or leadwires. WARNING EQUIPMENT DAMAGE Never immerse any part of the device, cables, or leadwires in liquids or allow liquid to enter the interior of the device. WARNING EQUIPMENT DAMAGE Do not autoclave any part of the system with steam or sterilize with ethylene oxide. WARNING EQUIPMENT DAMAGE If liquid has accidentally entered the system or its parts, disconnect the power cord from the power supply, remove the battery, and have the equipment serviced by qualified service personnel.

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Cleaning points to note

WARNING EQUIPMENT DAMAGE Do not pour or spray any liquid so that it may seep into connections or openings. WARNING EQUIPMENT DAMAGE Do not immerse the monitor in water. If monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth. WARNING EQUIPMENT DAMAGE Do not immerse sensors in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof).

Cleaning cautions CAUTION CROSS-CONTAMINATION To prevent cross-contamination, clean the exterior surfaces of the monitor, monitor accessories, and reusable sensors on a regular basis in compliance with your institution’s infection control unit and/or biomedical department’s local policy.

Disinfection notices NOTICE SPOTTING, STAINING, CORROSION Metal components including fasteners may corrode or become stained or spotted in appearance from continuous exposure to chlorine compounds like bleach. These effects are not associated with product safety or normal function.

Cleaning points to note Observe these guidelines while cleaning the device. • Your professional healthcare facility guidelines permitting, all cleaning activities may be carried out at the bedside. • Do not remove the monitor battery before cleaning. • Be especially careful when cleaning the displays. They are more sensitive to rough cleaning methods than for example the monitor housing. • Avoid contact with open vents, plugs, or connectors during the cleaning procedures. • Always dilute cleaning agents according to their manufacturer’s instructions. Always consider your professional healthcare facility guidelines as well. 5885338-01

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Disinfection points to note

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• Prolonged contact of cleaning solutions with metal parts may cause corrosion. • Do not clean any part of the system in automated cleaning. • Do not use excessive drying techniques, such as oven, forced heat, or sun drying. • Soiled devices must be separated from non-contaminated devices to avoid contamination of personnel or surroundings. • Warranty does not cover any damages caused by using other than GE approved substances and methods.

Disinfection points to note • Always clean before disinfecting. • Always dilute disinfectant agents according to their manufacturer’s instructions. Always consider your professional healthcare facility guidelines as well. • Use only the permitted substances. • Prolonged contact of disinfecting solutions with metal parts may cause corrosion.

Supplies needed for cleaning and disinfection

1. Cleaning/disinfection wipes (commercial) or detergent/disinfectant. 2. Cleaning: water, if required for rinsing off the detergent • Tap (utility) water is water that has not been processed. You can use tap water if it is not contaminated. 3. Disinfection: critical water, if required for rinsing off the disinfectant • Critical (sterile) water is water that is extensively treated to ensure microorganisms, inorganic, and organic materials are removed. 4. Non-linting cloths 10/26

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Permitted cleaning and disinfection agents

5. Cotton swabs 6. Disposable gloves and any other Personal Protective Equipment (PPE) recommended by your professional healthcare facility guidelines Replace soiled or dry wipes or non-linting cloths as needed. • Do not use sharp tools to clean the device. • Do not damage or bend connector pins when cleaning or disinfecting. • Do not use a dripping cloth on surfaces.

Permitted cleaning and disinfection agents All third party trademarks are property of their respective owners. Trademark names and product availability may vary in different countries. Consult the column that lists ingredients to determine if an equivalent disinfectant is available in your country. When using other than validated cleaning or disinfection agents, note the following: • Use only soft, non-linting cloths. • Prepare and use the agent according to the manufacturer instructions. • Do not use a dripping cloth. • Let the disinfectant remain on the device surface according to the manufacturer instructions. The following products are compatible with the devices and may be used for cleaning and disinfection. Product

Manufacturer

Active ingredient(s)*

Type of disinfectant

CaviWipes

Metrex Research, LLC.

• Isopropanol 17.20%

Alcohol

• Diisobutylphenoxyethyldimethyl benzyl ammonium chloride 0.28% Cleanisept Wipes

Dr. Schumacher GmbH

• Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides <1%

Quaternary ammonium compounds

• Didecyldimethylammonium chloride 0.25% Clinell Universal Sanitiz- GAMA Healthcare ing Wipes

• Benzalkonium chloride <0.5%

Quaternary ammonium

• Didecyl dimethyl ammoniumchlor- compounds ide ≤0.5% • Polyhexamethylene biguanide (PHMB) ≤0.10%

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Permitted cleaning and disinfection agents

Cleaning and Disinfection Supplement

Product

Manufacturer

Active ingredient(s)*

Type of disinfectant

Clinell Sporicidal Wipes

GAMA Healthcare

• Sodium Percarbonate 40 to ≤50%

Hydrogen peroxide and peracetic acid

• Citric acid ≤15% • Tetra acetyl ethylene diamine ≤25% Clorox Healthcare HyThe Clorox Company drogen Peroxide Cleaner Disinfectant Wipes

• Hydrogen peroxide 1.4%

Mikrozid Sensitive Wipes

• Didecyldimethyl ammoniumchlor- Quaternary ammonium ide 0.26%

Shülke & Mayr GmbH

Hydrogen peroxide

• Benzyl alcohol 1 to 5%

• Alkyl (C12-C16) dimethylbenzylammonium chloride 0.26% • Alkyl (C12-C14) ethylbenzylammonium chloride 0.26% PDI Sani-Cloth AF3 Germicidal Disposable Wipes

Professional Disposables Inc.

• n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chlorides 0.14%

Quaternary ammonium compounds and alcohol

• n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium chlorides 0.14% PDI Sani-Cloth Bleach Germicidal Disposable Wipes

Professional Disposables Inc.

Sani-Cloth Plus Germici- Professional Disposables dal Disposable Cloth Inc.

• Sodium Hypochlorite 0.63%

Chlorine

Quaternary ammonium • Quaternary ammonium compounds, C12-18-alkyl [(ethylphen- compounds yl) methyl] dimethyl, chlorides 0.125% • Benzyl-C12-18-alkyldimethyl ammonium chlorides 0.125% • Isopropyl alcohol 10-20% • Sodium hypochlorite

Sodium hypochlorite Generic 5.25% (Bleach) diluted to 10:1 (min. time to disinfect: 10 minutes)

Chlorine

*Active Ingredients are listed, as indicated in the table, from the disinfectant package or Material Safety Data sheet at the time of publishing this manual. All generic agents: check the minimum disinfection times as per your healthcare facility guidelines.

Do NOT use any of the following to clean the device because they may damage its surfaces: • Organic solvents • Abrasive cleaners or solvents of any kind • Acetone • Ketone • Betadine • Sodium salts

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How to clean and disinfect Cleaning during patient monitoring

Cleaning is NOT permitted when there is a patient present or during ongoing patient monitoring.

Cleaning and disinfection between patients

NOTE Before you start, please consult clinical personnel for any operations performed on the device (for example, removing batteries, disconnecting cables or devices). NOTE Follow this procedure only when there is no patient connected to the monitor and no ongoing monitoring.

Cleaning and disinfecting the monitor between patients NOTE Clean the devices thoroughly prior to disinfection. Follow these instructions.

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Cleaning and disinfecting the monitor between patients

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1.

Turn off the power on the device.

2.

Disconnect the DC power cable from the device.

3.

If needed, disconnect the cables from the device.

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Cleaning and disinfecting the monitor between patients

4.

If needed, disconnect the device from the roll stand.

5.

Put on new disposable gloves and any other Personal Protective Equipment (PPE) recommended by your professional healthcare facility guidelines.

6.

Get a new wipe.

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Cleaning and disinfecting the monitor between patients

7.

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Wipe the device's exterior surface. Remove any soil by wiping the device until soil and organic matter have been visibly removed.

Pay special attention to hard-to-clean areas like grooves and crevices. Scrub these areas with a cotton swab inside a wipe.

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Ensure there is no liquid pooling around connection pins. If this happens, blot dry with a cotton swab or soft non-linting cloth.

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9.

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Inspect the device to ensure the complete removal of soil from surfaces, cavities, and moveable parts. If visible soil remains, repeat cleaning procedure until the device is thoroughly clean.

10. If required, rinse the device thoroughly using a soft non-linting cloth saturated with lukewarm tap (utility) water temperature range 27 to 44°C, 81 to 111°F.

11. Allow the device to air dry until it is visibly dry. Drying times may vary based on the environmental conditions.

12. Discard disposable wipes, gloves, and other PPE according to your professional healthcare facility guidelines. Do not reuse wipes, gloves, or other PPE.

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Cleaning and disinfecting the monitor between patients

Cleaning and Disinfection Supplement

13. Start disinfection by putting on new disposable gloves and any other PPE recommended by your professional healthcare facility guidelines.

14. Get a new wipe.

15. Wipe the device surface. Make sure all surfaces are uniformly wiped. Treated surfaces must remain visibly wet for a minimum of two minutes or as directed by the disinfectant manufacturer. To ensure the surface remains visibly wet, use additional disinfectant wipes as necessary. Also refer to the instructions provided by disinfectant manufacturer.

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Cleaning and disinfecting the monitor between patients

Pay special attention to hard-to-clean areas, like grooves and crevices. Scrub those areas using a cotton swab inside a wipe.

16. Ensure there is no liquid pooling around the pins. If this happens, blot dry with a cotton swab or soft non-linting cloth.

17. If required, manually rinse the device by wiping it for 30 seconds using a sterile, soft, non-linting cloth saturated with lukewarm critical (sterile) water temperature range 27 to 44°C, 81 to 111°F.

18. Allow the device to air dry until it is visibly dry. Drying times may vary based on the environmental conditions.

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19. Discard disposable wipes, gloves, and other PPE according to your professional healthcare facility guidelines. Do not reuse wipes, gloves or other PPE.

20. Put on new disposable gloves.

21. If needed, reconnect the device to the roll stand.

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22. Reconnect the DC power cable to the device.

23. Remove and discard gloves according to your professional healthcare facility guidelines.

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