Products Cleaning, Disinfecting and Sterilizing Guidelines

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Point of use

7.1 Materials and equipment – Personal Protective Equipment (PPE: disposable gloves, proper protective gear). – Lint free nonwoven wipes. – Sterile cold water (< 40 ° C, < 104 ° F). 7.2 Disassembly procedure – Disinfect your hands. – Put on disposable gloves and proper protective gear. – Disassemble if possible. Housing suction pumps: remove Safety Set as shown. Suction pumps in general: Remove all accessories if attached.

7.3 Initial manual cleaning procedure – Directly after use (within a maximum of 2 hours post-procedurally) wipe the surfaces to remove all gross debris by using a lint free nonwoven wipe wetted with sterile cold water (< 40 ° C, < 104 ° F). – Ensure that all surfaces are thoroughly wetted. – Wipe again using another wipe and keep moist for a minimum of 5 minutes then repeat it with another wipe. – Dispose of protective gloves. – Disinfect your hands. 7.4 Cautions – Before cleaning electrical devices, disconnect the power plug from the power socket. – Clean all surfaces immediately after use (maximum 2 hours post-procedurally) to avoid residues from drying and to prevent growth of microorganisms. – Never use steel brushes or steel wool for cleaning. – Water temperatures higher than 45 ° C (113 ° F) can cause protein coagulation which may affect the efficacy of the process. – Never place the device in water or other liquids.

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8

Thorough cleaning

8.1 Materials and equipment – Personal Protective Equipment (PPE: disposable gloves, proper protective gear). – Lint free nonwoven wipes wetted with an enzymatic detergent. – Sterile cold water (< 40 ° C, < 104 ° F). 8.2 Thorough manual cleaning procedure – Disinfect your hands. – Put on disposable gloves and proper protective equipment. – Use the wipes wetted with an enzymatic detergent according to the manufacturer’s instructions for use. – Ensure that all surfaces are thoroughly wetted. – Check surfaces for visible dirt and repeat these steps if necessary. – At the end use a wipe wetted with sterile cold water (< 40 ° C, < 104 ° F) to wipe surfaces. Repeat these steps if necessary. 8.3 Procedure drying – Allow surfaces to dry after thorough manual cleaning before use. – Dispose of protective gloves. – Disinfect your hands. 8.4 Cautions – Before cleaning electrical devices, disconnect the power plug from the power socket. – Never use steel brushes or steel wool for cleaning. – Water temperatures higher than 45 ° C (113 ° F) can cause protein coagulation which may affect the efficacy of the process. – Never place the device in water or other liquids.

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9

Intermediate level disinfection

9.1 Materials and equipment –  Personal Protective Equipment (PPE: disposable gloves, proper protective gear). –  D isinfecting wipes. 9.2 Manual disinfection –  D isinfect your hands. –  Put on disposable gloves and proper protective equipment. –  U se disinfecting wipes according to the manufacturer’s instructions for use. – After 5 minutes wipe with another disinfecting wipe. 9.3 Drying –  A llow the surface to dry for a minimum of 5 minutes. –  D ispose of protective gloves. –  D isinfect your hands. 9.4 Caution –  N ever place the device in water or other liquids. 9.5 Recommended agent: –  C aviWipes ® Metrex ® Research Address: 1717 West Collins Avenue, Orange, CA 92867, U.S.A. Homepage: http://www.metrex.com Phone: (800) 841 1428 Email: [email protected] –  M ikrozid ® AF Wipes Schülke&Mayr GmbH Address: Robert-Koch Str. 2, 22851 Norderstedt, GERMANY Homepage: http://www.schuelke.com Phone: +49 (0) 40 521 00 0 Email: [email protected]

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13

Point of use

13.1 Materials and equipment – Personal Protective Equipment (PPE: disposable gloves, proper protective gear) – S terile cold water (< 40 ° C, < 104 ° F) 13.2 Procedure disassembly – D isinfect your hands. – Put on disposable gloves and proper protective equipment. – P C jars: –  W hen used with the disposable liners from Medela: remove liners according to suction pump’s instructions for use, chapter 10 –  R emove jar from clamp holder – Q uiver: –  R emove from holder 13.3 Initial cleaning with rinsing water – R emove gross debris. – R inse all parts with sterile cold, running water (< 40 ° C, < 104 ° F) for 3 minutes. – D ispose of protective gloves. – D isinfect your hands. 13.4 Cautions – C lean all parts immediately after use (maximum 2 hours postoperatively) to avoid drying of residues and to prevent growth of microorganisms. – N ever use steel brushes or steel wool for cleaning. – Water temperatures higher than 45 ° C (113 ° F) can cause protein coagulation which may affect the efficacy of the process.

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Thorough cleaning and thermal disinfection

14.1 Materials and equipment – Disposable gloves 14.2 Automated cleaning and disinfection with washer disinfector – Disinfect your hands. – Put on disposable gloves. – Load items into the washer disinfector. – Choose the washer disinfector washing cycle. – Operate the washer disinfector.

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– On completion, unload the washer disinfector. – V isually check for remaining soil and dryness. If soil remains, repeat the procedure cleaning and disinfection with washer disinfector. – R emaining wetness may be removed with medical grade compressed air or by heating in an oven below 110 ° C (230 ° F). 14.3 Washer disinfector cycle information Pre-wash

1l water, temperature 10°C, time 1 minute

Cleaning

1l water, temperature 40°C, time 3 minutes, dosage 0.3% neodisher® FA

Neutralization

1l water, temperature 60°C, time 2 minutes, dosage 0.1% neodisher® Z

Intermediate rinse

1l water, temperature 10°C, time 1 minute

Disinfection

1l water, temperature 93°C, time 5 minutes

Drying

temperature 50°C, time 17 minutes

14.4 Inspection procedure – C heck the parts visually for damage and throw away at first signs of damage or weakness. – D ispose of protective gloves. – D isinfect your hands. 14.5 Cautions – Water temperatures higher than 45 ° C (113 ° F) during the cleaning cycle can cause protein coagulation which may affect the efficacy of the process. – Avoid contact between items (movement during washing could cause damage). – A rrange items so that channels and openings are always oriented downwards – Please follow instructions for use of manufacturer: – for washing disinfector and – for detergents and disinfectants – If available, attach tubing to nozzles in washer disinfector.

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14.6 Recommended agents for thorough cleaning and thermal disinfection: – n eodisher ® FA as the Liquid Detergent and neodisher ® Z as the Liquid Neutralizing Agent Miele, Inc. Address: 9 Independence Way, Princeton, NJ 08540, U.S.A. Homepage: http://www.miele.us Phone: (800) 991 9380 Email: [email protected] – n eodisher ® FA as the Liquid Detergent and neodisher ® Z as the Liquid Neutralizing Agent Chemische Fabrik Dr. Weigert GmbH & Co. KG Mühlenhagen 85, D-20539 Hamburg, GERMANY Homepage: http://www.drweigert.com

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Storage

15.1 Reassembly procedure and storage – W here appropriate, the cleaned, disinfected and checked medical products should be prepared for Re-Use. – S ufficient protection of the medical products must be provided in order to keep medical products dry and dust free. 15.2 Caution – S tore medical products dry and dust free.

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Phone numbers

Medela AG Lättichstrasse 4b 6341 Baar, Switzerland www.medela.com International Sales Medela AG Lättichstrasse 4b 6341 Baar, Switzerland Phone +41 41 562 51 51 Fax +41 41 562 51 00 [email protected] www.medela.com

Local contact:

© Medela AG/200.2391/2017-06/K

For additional information on the device, including questions on infection control procedures, please call: USA (+1) 877 735 1626, International (+41) 41 562 51 51