medela PLUS Reusable Hospital Pump Set for Symphony Instructions

medela PLUS Reusable Hospital Pump Set for Symphony

Introduction

Any serious incident that has occurred in relation to the Symphony pump set should be reported to Medela AG and the relevant Competent Authority.

Product Description

The reusable Symphony pump set is an accessories kit for multiple use with a Symphony breast pump. It contains (see Fig. 1):

1. Personal Fit PLUS breast shield
2. Connector with connector lid
3. Membrane
4. Bottle
5. Tubing
6. Symphony cap
7. Lid

Refer to Symphony breast pump instructions for use for instruction on operating the pump and pump set.

Intended Use/purpose

The Symphony reusable pump set is intended to be used by lactating women in the hospital for expressing breast milk with the Symphony breast pump. The pump set is a multi-user product.

Indications for Use/Contraindications

Refer to Symphony breast pump instructions for use.

Important Safety Information

Meaning of non harmonised symbols:

Read and follow the instructions for use
Indicates that the packaging contains products intended to come in contact with food according to regulation (EC) No 1935/2004
Indicates the package is capable of being recycled
Recycling PAP parts
Recycling LPDE parts
Indicates compliance with the EU requirements concerning medical devices

Warning
To avoid health risk and reduce risk of injury:

• Supervision is necessary when the Symphony breast pump is used in the vicinity of children.
• Inspect all components of the pump set(s) before each use.
• Never use a device, components or parts that are damaged.
• Never use a device, components or parts if dried in milk residues, soil or other contamination is visible.
• Replace visibly contaminated, non-reprocessable, damaged or worn parts.
• To minimise the risk of cross-contamination, the pump set must not be shared between mothers without appropriate reprocessing.
• Use Medela original accessories only.
• Do not use attachments not recommended by Medela, as this may cause hazards.
• Do not modify any parts of the pump set.

Important!

• Plastic bottles and component parts become brittle when frozen and may break when dropped.
• Bottles and component parts may become damaged if mishandled, e.g. dropped, over-tightened, or knocked over.
• Take appropriate care in handling bottles and components.
• Do not use the breast milk if bottles or components become damaged.

Caution
To avoid risk of contamination:

• Only use drinking-quality tap or bottled water for cleaning.
• Do not store wet or damp parts, as mould may develop.

Cleaning and Hygiene

The listed reprocessing procedures are tested, validated and recommended by Medela. In the case of automated cleaning, an internal validation of the preferred procedure by the hospital is necessary, too. In the event of conflicting national cleaning and sterilisation requirements, these shall prevail over the Medela recommendations.

Warning

• This is a non-sterile product. Reprocess all parts that come in contact with the breast and breast milk prior to first use.
• Use by more than one mother without adequate reprocessing may be a health risk and could cause cross-contamination.
• Clean parts that come in contact with the breast and breast milk immediately after use.

Caution

• Use drinking-quality water for cleaning.
• Use of other sanitising methods (e.g. cold water disinfection) is not recommended and may damage some parts.
• Do not use abrasive washing-up liquids/detergents when cleaning the breast pump, pump components or pump set parts.

Preparation before cleaning

• Disassemble the pump set into its individual parts (Personal Fit PLUS breast shield, connector with connector lid, membrane, bottle, tubing, Symphony cap, lid).
• Check all parts for damage. Replace damaged or worn parts.
• Perform reprocessing as specified in the table below.

Cleaning Procedures

A. Manual cleaning

• For cleaning of tubing and Symphony cap see B.
• Rinse all parts, with cold, clear water (approx. 20°C).
• Clean these parts with plenty of warm, soapy water (approx. 30°C). Use a commercially available washing-up liquid, preferably without artificial fragrances and colouring (pH neutral).
• Rinse the parts with cold, clear water (approx. 20°C).
• Dry the clean parts with a clean cloth or leave to dry on a clean cloth.

Cleaning of parts except for tubing and Symphony cap (see chapter B)| Procedures
---|---
Before first use| Automated cleaning and disinfection (see chapter C)
After each use| Automated cleaning and disinfection or manual cleaning
(as long as the pump set stays with the mother)| (see chapter A or C)
Before passing onto the next mother| Automated cleaning and disinfection (see chapter C)
If national, regional or in-house regulations require sterilization| Automated cleaning and disinfection or manual cleaning (see chapter A or C) is followed by autoclave sterilisation (see chapter D)

B. Manual cleaning – tubing and Symphony cap With visible residues:

• Dispose and replace the tubing and Symphony cap. No visible residues:
• Before first use or before passing on to the next mother, external wipe disinfection is recommended.
• Soak a clean cloth in an alcohol-based disinfectant, alternatively use alcohol-based, wet disinfectant wipes.
• Wipe dry with a clean cloth. Use alcohol-based disinfectants that contain no additives and dry without leaving residues.
• After max. 6 months, dispose of the tubing and replace.

C. Automated cleaning and disinfection

• For cleaning of tubing and Symphony cap see B.
• Clean and disinfect the parts in a mechanical washer disinfector. Use appropriate inserts for the disinfection of small parts. Use a common cleaning detergent for washer disinfectors (NTA-, phosphate-, chlorine- and ten side-free, alkaline with pH level 11.7–12.7).
• Disinfect for 5 minutes at a temperature of 93°C. Select an appropriate program that includes drying. If the appropriate program does not include drying, dry the clean parts with a clean cloth or leave to dry on a clean cloth.

D. Sterilisation

• Check that the parts of the pump set are clean, intact, clean and dry.

• Wrap all parts, except tubing and Symphony cap, in appropriate sterile packaging and seal.

• Sterilise the product in the autoclave at 134°C for 5 minutes.
  To avoid damage, do not stack or apply external pressure.

• Leave the parts in the sterile packaging and store them in a clean, dry and dust-free environment.

Storage

• It is important that all residual moisture dries. Do not store in an airtight container/bag.
• Put the clean parts in a clean environment.

Preparing for Pumping

• Make sure to use the correct breast shield size. It is an essential component of effective pumping, helping to optimise milk flow. For breast shield fitting guidelines refer to Symphony hospital instructions for use.
• Use a bottle according to the individual needs (various bottle sizes available).

Assembly

• Wash your hands thoroughly with soap and water before touching the clean breast pump, the pump set(s) and breasts. Dry your hands with a fresh towel or a single-use paper towel. Avoid touching the inside of bottles or lids.

• Carefully place the membrane into the connector as shown in Fig. 1. Make sure that the membrane forms a seal around the edge of the connector.

• Close the connector lid until it audibly clicks.

• Carefully push the breast shield onto the connector. Choose a breast shield size that suits your needs.

• Screw the bottle onto the connector. Choose a bottle size that suits your needs.

• Insert the tubing adapter into the corresponding opening in the connector lid (Fig. 2).

• Insert the tubing adapter into the opening in the Symphony cap (Fig. 2).

• Open the lid of the breast pump: Press the oval button on the top of the Symphony pump and lift the handle.

• Position the Symphony cap firmly on the breast pump membrane to form a seal. Make sure that the Symphony cap engages and lies flush to the surface (Fig. 2).
  

• Centre the tubing connector in the recess in the pump housing.

• Close the lid of the breast pump

Refer to Symphony hospital instructions for use for instruction on operating the pump and pump set for expression.

Part List

008.0486 Symphony pump set hospital multibox (S)
008.0465 Symphony pump set hospital multibox (M)
008.0466 Connector Kit
008.0467 PersonalFit PLUS breast shield S (21 mm)
008.0468 PersonalFit PLUS breast shield M (24 mm)
008.0469 PersonalFit PLUS breast shield L (27 mm)
008.0470 PersonalFit PLUS breast shield XL (30 mm)
008.0471 PersonalFit PLUS breast shield XXL (36 mm)
008.0472 Membrane
008.0473 Tubing
008.0474 Symphony cap

Material

• Breast shield, connector, connector lid, bottle, Symphony cap, lid: Polypropylene
• Membrane, tubing: Silicone
• Tubing plug: Polybutylene terephthalate

Disposal

According to local regulations. Contaminated products may be handled and disposed of in the same manner as hospital waste and bio-hazardous materials in accordance with local regulations and hospital policy.

Customer Support

Medela AG
Lättichstrasse 4b
6340 Baar, Switzerland
www.medela.com
Medela Australia Pty Ltd
3 Arco Lane,
Heatherton, Vic 3202
Australia
www.medela.com.au

References

• Breastfeeding & Pumping
• Medela | Breastfeeding products and medical vacuum technology | Medela

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