PHILIPS EL10167 ECG Lead Sets Cables and Adapter Cables User Manual

June 10, 2024
Philips

PHILIPS EL10167 ECG Lead Sets Cables and Adapter Cables User Manual

Stryker Internal Control No.: EL10167 Rev A


The IntelliVue Reusable ECG Lead Sets and Trunk Cables Instructions for Use lists parts applicable to this manufacturer.

The following Instructions for Use lists parts applicable to this manufacturer: • IntelliVue ECG Trunk and MX40 ECG/SpO2 Adapter Cables Instructions for Use • IntelliVue MX40 Reusable Patient Cables Instructions
for Use • IntelliVue MX40 with Masimo SET® Reusable Adapters and Patient Cables Instructions for Use • Efficia Reusable ECG Lead Sets and Cable Instructions for Use.

– ECG Lead Sets, Cables and Adapter Cables Care, Cleaning and

Disinfection

Please store this addendum with your product documentation. Associated Documents – This document provides care, cleaning, and disinfection procedures specific to the ECG lead sets, trunk cables, and adapter cables. Refer to the specific Instructions for Use for information about the proper use of your products. Validated Cleaner and Disinfectant – Philips has validated the following cleaner and disinfectant which were tested for efficacy and use on the lead sets and cables. These agents were tested by Philips for both efficacy and prevention of damage to the Philips products being cleaned and disinfected. Cleaner: Enzymatic detergent composition. Refer to the detergent manufacturer’s label for proper concentration and water temperature requirements: • Alcohol, C9 11, ethoxylated surfactant (1-5%), • Glycerin (1-5%), • Citric Acid (1-5%), • N, N-Dimethyloctadecylamine oxide (1-2%), • Subtilisins (proteolytic enzymes) (0.1-1%).
Disinfectant: 70% Isopropyl Alcohol (Chemical Abstract Service #67-63-0). Do not use the following disinfectants because they will damage the product: • Henanios G+R, • Incidin® Plus,

  • Microbac® Forte, • Surfanios Citron • Virex® Tb RTU. Components – Lead sets, cables and adapter cables consist of parts that can be cleaned and disinfected. Refer to the sample graphic on page i. Getting Started – Before cleaning and disinfecting the product: 1-Visually inspect the lead sets, trunk cables, and adapter cables for any visible damage or deterioration. Check for any tears, cracks, or bent connector pins. Discard the product if damaged since there is a potential for incorrect readings. 2-Always replace the product when there is any visible damage to the product (such as, exposed wires or breaks). 3-Visually inspect the product for moderate to severe soiling. Products with moderate to severe soiling are not intended to be cleaned or disinfected.
    If this situation occurs, dispose of the product according to your institution’s recommended disposal procedure for hospital waste. Refer to Disposal in the product’s Instructions for Use for the
    additional information.

Care of Lead Sets, Cables and Adapter Cables – Caution:

Never submerge the products in any aqueous solution. Note: Never sterilize lead sets or cables.
Preparation – Before cleaning and disinfecting, secure the following supplies: • non-linting wipes, • cotton swabs with tapered mini tips, • the validated cleaner and disinfectant (from above list) using the concentration recommended by the cleaner and disinfectant manufacturer. Cleaning Lead Sets, Cables and Adapter Cables – The following cleaning and disinfection procedures refer to the product components shown on page i. Note: The figures on page i represents an example of Philips lead sets, cables, and adapter cables. The figures are not intended to be identical to your specific product. Start-up • Position the monitor connector end of the cable to ensure that no liquid can enter the inside of the connector during cleaning.

  • The term saturate in a step refers to a very wet condition, but not to the point where dripping occurs. • If at any time during the procedure the non-linting wipes become visibly soiled, discard soiled wipes and use more clean wipes.
  • Use cotton swabs during the procedure, as needed, to reach seams, grooves, and narrow spaces. • Remove any attached accessories, such as the lead set organizer or SpO2 protection cap holder.

Cautions

  • To prevent fluids from entering the connector end of the cable, leave the SpO2 protection cap on the SpO2 cable. • If the SpO2 protection cap is lost or damaged, then discard the lead set and use another lead set with the protection cap.
    To Clean – 1-Saturate a non-linting wipe with the validated cleaner; 2-Saturate all surfaces of the product with the cleaner; 3-Saturate the surfaces of all accessories; 4-Allow surfaces to remain visibly wet for 3-5 minutes; 5-Dampen another non-linting wipe with cleaner; 6-Wipe the monitor connector, cable and accessories until they are visibly clean. Be sure to clean both sides of the product. Do not allow liquid to come in contact with the inside of the monitor connector; 7-Wipe the lead set and lead set cable connector. Thoroughly clean both sides of the product. To Rinse
    – 1-Saturate a non-linting wipe with tap water; 2-Start at the monitor-end connector and wipe the monitor-end connector, trunk cable, and each lead and connector at least one time; 3-Wipe all accessories; 4-Visually inspect the product and repeat steps 6 and 7, if needed. If any part is not visibly clean, use a cotton swab to clean between the grooves and narrow spaces; 5-Using clean wipes, dry both sides of the product; 6-Proceed with Disinfecting the Lead Sets, Cables and Adapter Cables. Disinfecting the Lead Sets, Cables and Adapter Cables – Start-up –

  • Position the monitor end connector to ensure that no liquid can enter the inside of the cable or come in contact with the electrical contacts • If at any time during the procedure non-linting wipes become visibly soiled, discard soiled wipes and use clean wipes. • Use cotton swabs during the procedure, as needed, to disinfect and rinse seams, grooves, open areas, and narrow spaces.

  • Cover the SpO2 connector with the protection cap, if applicable. To Disinfect – 1-Saturate a non-linting wipe with the validated disinfectant; 2-Thoroughly saturate all surfaces of the product, including accessories such as the lead set organizer; 3-Allow surfaces to stay visibly wet for 10 minutes. Ensure that all seams, grooves, and narrow spaces between the leads are saturated.
    To Rinse and Complete Final Inspection – 1-Saturate a non-linting wipe with tap water; 2-Start at the monitor-end connector and wipe to (and including) each lead and connector; 3-Wipe the lead-set organizer; 4-Repeat steps 2 and 3 two more times, using more wipes as needed; 5-Using clean wipes, dry the entire product, including the accessories; 6-Reattach the accessories;
    7-Visually inspect the product to ensure that all the surfaces are clean and dry.

To contact your local Philips sales office: www.healthcare.philips.com

Philips Medical Systems 3000 Minuteman Road
Andover, MA 01810-1099 USA

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