Symphony Instructions for Use Rev E Nov 2016

Table of Contents 4

1. Intended use / population / contraindication 2. Meaning of symbols 3. Important safety information 4. Product description 5. Cleaning 5.1 Before using for the first time 5.2 After each use 5.3 Once a day 5.4 Breast pump - Cleaning and disinfection 6. Preparing for pumping 6.1 Card and cord protector 6.2 Mains operation 6.3 Changing the program card 6.4 Assembling the pump set 7. Expression 7.1 Selecting the breast shield 7.2 Selecting the right program 7.3 Operation: Standard program 7.4 Set comfort vacuum 7.5 Operation: INITIATE program 7.6 Operation: MAINTAIN program 7.7 Expression by single pumping 7.8 Expression by double pumping 8. Storing and thawing breast milk 8.1 Storage 8.2 Freezing 8.3 Thawing 9. Troubleshooting 9.1 Troubleshooting 9.2 Error codes 10. Warranty and maintenance / disposal 11. Complete care during breastfeeding time 12. Technical specifications

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1. Intended use / population / contraindication The intended use and indications of breast pumps Breast pumps are intended to be used by lactating women in the hospital or home environment for expressing breast milk. Breast pumps are indicated to alleviate the symptoms of engorgement by expressing milk. In cases of mastitis, breast pumps support the healing process by removing breast milk from the affected breast. Breast pumps are indicated to relieve sore and cracked nipples and to bring out flat or inverted nipples. Also, breast pumps enable mothers to provide breast milk for babies who cannot feed directly at the breast for a variety of reasons, such as latch-on problems, cleft palate or premature babies. Intended patient population / user Adolescent paediatric or adult lactating women. Many women find it convenient, or even necessary, to use a breast pump to express and store their breast milk once they have returned to work, if they are travelling, or are otherwise separated from their babies. Women are often delighted to learn that a breast pump can be used as a supplement to breastfeeding and that some pumps are designed to mimic the sucking of a nursing baby. Contraindications There are no known contraindications for the Symphony* breast pump. Product description The Symphony multi-user breast pump is provided with the Symphony PLUS program card, which generates the pump suction patterns. The program card contains two pump programs. The goal of the INITIATE program is to initiate milk production with Medela’s initiation technology. The MAINTAIN program is designed to build and maintain milk production with the 2-Phase Expression technology. In some cases, the Symphony breast pump is provided with the Standard program card to generate the pump suction patterns. This program is designed to build and maintain milk production with 2-Phase Expression technology. While the Standard card can be used to initiate lactation, Medela recommends using the INITIATE program of the Symphony PLUS program card. The 2-Phase Expression technology mimics the baby’s natural sucking rhythm. Short, stimulating cycles in the stimulation phase are followed by longer ones in the expression phase. * Symphony is a trademark of Medela AG

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2. Meaning of symbols The warning symbol identifies all instructions that are important for safety. Failure to observe these instructions can lead to injury to the user or damage to the breast pump. There are several warning symbols/word combinations. These have the ­following meanings:

Warning Can lead to serious injury or death.

Caution Can lead to minor injury.

Symbols on the packaging

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Note

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Info

Can lead to material damage. Useful or important information that is not related to safety.

This symbol indicates that the material is part of a recovery/recycling process. This symbol indicates a cardboard package. This symbol indicates that the device should be kept away from sunlight. This symbol indicates a fragile device that should be handled with care. This symbol indicates the temperature limits for operation, transport and storage. This symbol indicates the humidity limits for operation, transport and storage. This symbol indicates the atmospheric pressure limits for operation, transport and storage. This symbol indicates that the device should be kept dry. This symbol indicates that the packaging contains products intended to come in contact with food according to regulation 1935/2004. This symbol indicates unique GSI Global Trade Item Numbers (GTIN).

Symbols on the device This symbol indicates that the instructions for use should be followed. This symbol indicates compliance with the essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

This symbol indicates the manufacturer.

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This symbol indicates that the device should not be disposed of with unsorted municipal waste (for EU only). This symbol indicates compliance with additional USA and Canada safety requirements for medical electrical equipment. This symbol indicates a type BF applied part. This symbol indicates the manufacturer's serial number for the device. This symbol indicates the manufacturer's catalogue number for the device. This symbol indicates protection against ingress of solid foreign objects and against harmful effects due to the ingress of water. This symbol indicates the date of manufacture (four digits for the year and two digits for the month). This symbol indicates Class-II protection against electric shock with double or reinforced insulation. This symbol indicates the fuse (to identify fuse boxes or their location). This symbol indicates that the fuse box is safety tested. This symbol indicates that the cover of the mains socket should be opened. On/off button

Let-down button

Vacuum adjustment knob

Symbols on the display Vacuum level indicator, stimulation phase – Standard program card and Symphony PLUS program card (MAINTAIN program). Vacuum level indicator, expression phase – Standard program card and Symphony PLUS program card (MAINTAIN program). Vacuum level indicator – Symphony PLUS program card (INITIATE program).

3. Important safety information 8

3.1 Warnings Failure to follow the instructions/safety information below can lead to danger from the device. This information is subject to technical changes. READ ALL INSTRUCTIONS BEFORE USE

WARNING: To reduce the risk of electrocution: l  Keep the device dry. Never immerse in water or other liquids! l  D o not spray or pour liquid directly onto the pump unit. l  D o not place or store the device where it can fall or be pulled into a sink or tub. l  D o not use the Symphony breast pump while bathing or showering. l  D o not reach for any electrical device if it has fallen into water. Unplug it ­i mmediately. l  A lways unplug the Symphony breast pump immediately after use.

WARNING: To avoid fire, electrocution or serious burns: l  T he Symphony breast pump is not heat-resistant: keep it away from radiators and naked flames. l  D o not expose the motor unit to direct sunlight. I  D o not operate the Symphony breast pump where aerosol (spray) products are being used or where oxygen is being administered. I  D o not use the device in the presence of a flammable anaesthetic mixture with air, or with oxygen or nitrous oxide. I Do not thaw frozen breast milk and do not warm breast milk in a microwave or in a pan of boiling water. Microwaving can cause severe burns to the baby’s mouth from hot spots that develop in the milk during heating. Microwaving can also change the composition of breast milk. I Use only the power cord that comes with the Symphony breast pump. Make sure that its rated voltage is compatible with the power source. l  N ever operate an electrical device if it has a damaged power cord, if it is not working properly, if it has been dropped or damaged, or dropped into water. I  A lways inspect the power cord wires prior to use for damage or exposed wire. If any damage is found, stop using the power cord immediately. Contact the local Medela representative or rental agency.

l  T he Symphony breast pump should never be left unattended when plugged into a power source. l  S eparation from the mains is only assured by disconnecting the power cord from the wall socket. l  Position the pump unit such that it is easy to disconnect the power cord from the wall socket. l  Keep the power cord away from heated surfaces.

WARNING: To avoid health risks and reduce risk of injury: I Clean all reusable parts that come in contact with the breast and breast milk prior to first use as shown in chapter 5.1. I Clean parts that come in contact with the breast and breast milk immediately after use. I If breast milk overflow occurs, reprocess according to the instructions in chapter 5.2. I The pump sets are personal care items intended for use by a single user only. They should not be shared between mothers. I Do not continue pumping for more than two consecutive pumping sessions if no results are achieved. I If problems or pain occur, consult a lactation specialist. I Never use the pump during pregnancy, unless prescribed/advised by a physician, as pumping can induce labour. I For mothers who are infected with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV): pumping breast milk will not reduce or remove the risk of transmitting the virus to the baby through breast milk. I  I nspect all components of the Symphony breast pump as well as all parts of the pump set(s) before each use. l  N ever use a device, components or parts that are damaged. l  N ever use a device, components or parts if dirt, mould or other contamination is visible. l  R eplace mouldy, damaged or worn parts. l  T here are no user-serviceable parts inside the Symphony pump unit. Repairs must be performed only by an authorised service agency. Do not repair the parts yourself! No modifications to the device are permitted. l  U se the Symphony breast pump only for its intended use as described in this manual.

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3. Important safety information 10

WARNING: To avoid health risks and reduce risk of injury: l  U se only original Medela accessories. l  D o not use attachments not recommended by Medela, as this may cause hazards. l  D o not modify any parts of the pump or the pump set. l  D o not use the Symphony breast pump while sleeping or overly drowsy. l  D o not use the Symphony breast pump while operating a motor vehicle. l  D o not drive while using hands-free pumping. l  N ever drop or insert any object into any opening or tubing. l  D o not use the pump outdoors. l  S upervision is necessary when the Symphony breast pump is used in the vicinity of children. l  R adio frequency communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations as well as walkie-talkies can affect the Symphony breast pump. Due to electromagnetic compatibility (EMC), a distance of at least one meter between the Symphony breast pump and the wireless equipment is recommended.

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

3.2 Cautions Failure to follow the instructions/safety information given below can lead to minor injury. This information is subject to technical changes.

CAUTION: To avoid risk of contamination: I Wash your hands thoroughly with soap and water before touching the breast pump, the pump set(s) and breasts. Avoid touching the inside of containers or lids. I Only use drinking-quality tap or bottled water for cleaning. I Do not store wet or damp parts, as mould may develop.

CAUTION: To avoid health risks and reduce risk of injury: I Pump only with the breast pump in an upright position. I Pressing shields too firmly onto the breasts may affect the milk flow. I Do not express with a vacuum that is too high and uncomfortable (painful). The pain, along with potential breast and nipple trauma, may decrease the milk output. I Do not attempt to remove the breast shield from the breast while pumping. Turn the breast pump off and break the seal between the breast and the breast shield with a finger, then remove the breast shield from the breast. I If pumping is uncomfortable or causing pain, turn the unit off, break the seal between the breast and the breast shield with a finger and remove the breast shield from the breast. I Do not shorten the tubing between the breast shield and the pump. I Do not use abrasive washing-up liquids/detergents when cleaning the breast pump, pump components or pump set parts. I Never put the breast pump unit in water, as this can cause permanent damage to the breast pump. I Do not use Medela Symphony pump sets with a non-compatible breast pump. I Do not use the Medela Symphony breast pump with non-compatible pump sets. I Do not use the pump sets for any other purpose than expressing breast milk.

CAUTION: To reduce risk of electrocution: I Plug the power cord into the breast pump first and then into the wall socket. I Unplug the breast pump before cleaning it.

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4. Product description Symphony single or double pump set

12 (applied parts)*

The Symphony single or double pump set is an accessory for the Symphony breast pump. The pump set must be used by only one mother; use by more than one mother could pose a health risk. The double pump set contains two pieces of each part.

The pump set contains: The PersonalFit breast shield, size M (24mm). You can find more information on the correct choice of breast shield size in chapter 7.1 or at www.medela.com/personalfit.

1x PersonalFit™ breast shield M (24 mm) (for other breast shield sizes see chapter 11)

1x PersonalFit™ connector

1x valve head 2x valve membrane

1x milk bottle (150 mL, printed) 1x silicon tubing (105 cm)

1x membrane cap 1x protective membrane

1x protective cap

1x disc

1x lid with opening

Rental pump required: Symphony

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LCD display Let-down button Vacuum adjustment knob

On/off button

Case

Bottle holder Card and cord protector Socket for car connection cable Power cord symphony

®

Symphony Standard program card

PLUS

or

Symphony PLUS program card SAMPLE – Not for clinical use

English

For more information on all Medela products, see www.medela.com * Accessories available for order can be found in chapter 11. Articles may not be available in all countries. For further information about Medela products, visit www.medela.com and look for location finders. Medela AG Lättichstrasse 4b 6341 Baar, Switzerland www.medela.com

200.9186

Symphony PLUS program card for use with the Symphony breastpump

5. Cleaning Caution

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l O nly use drinking-quality water for cleaning. l Take apart and wash all parts that come in contact with the breast and breast milk immediately after use to avoid drying up of milk residues and prevent growth of bacteria.

5.1 Before using for the first time Before using the pump set for the first time, you must clean it thoroughly. Proceed as follows: I First perform the steps described in chapter 5.2. I Then perform the steps described in chapter 5.3.

Note

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l The pump set requires no maintenance. l Take care not to damage parts of the pump set during cleaning. l If the individual parts of the pump set are cleaned in a dishwasher, they may be discoloured by food pigments. This has no impact on their function. l Inspect the tubing after each pumping session for milk, condensation or visible residues. If there is milk, condensation or visible residues in the tubing, follow the instructions in step 2 of chapter 5.2.

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Rinse all parts, except for the tubing, with cold, clear drinking-quality water (approx. 20 °C) to remove proteins. Clean these parts with plenty of warm, soapy water (approx. 30 °C) to wash off fat. Use a commercially available washing-up liquid, preferably without artificial fragrances and colouring (pH neutral). Rinse the parts with cold, clear drinking-quality water (approx. 20 °C).

5.2 After each use

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2

1

Disassemble the pump set into its individual parts (bottle, breast shield, connector, valve head, valve membrane, membrane cap, protective membrane and tubing). To remove the white membrane from the yellow valve head, use two fingers with one gently pushing onto the “knob”. Check all parts for damage. Replace damaged or worn parts.

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Drying / storage

Dry with a clean cloth or leave to dry on a clean cloth. Put the clean parts in a clean storage bag or a clean environment. It is important that all residual moisture dries. Do not store parts in an airtight container/bag.

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step 3

I No milk, condensation or visible residues in the tubing No cleaning needed. IW  ith milk, condensation or visible residues Clean the tubing as described in step 3, then disinfect it by boiling it in water for 5 minutes. Shake out any water drops. Let the pump run with the tubing attached until the tubing is dry.

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Dishwasher

As an alternative to the previous steps 3 and 4, you can also clean the pump set in the dishwasher. Place all parts, except for the tubing, on the top rack or in the cutlery section. Use a commercially available dishwashing detergent.

5. Cleaning Caution

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l Do not spray or pour liquid directly onto the pump. l O nly use drinking-quality water for cleaning. l Take apart and wash all parts that come in contact with the breast and breast milk immediately after use to avoid drying up of milk residues and prevent growth of bacteria. l For chapter 5.4 Breast pump - Cleaning and disinfection: Unplug the breast pump before cleaning.

5.3 Once a day 1

Clean the individual parts as explained in chapter 5.2, steps 1, 2 and 3.

Note

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l For step 2a (chapter 5.3): When boiling, a teaspoon of citric acid may be added to the water to avoid a build-up of limescale.

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Drying / storage

Dry with a clean cloth or leave to dry on a clean cloth. Put the clean parts in a clean storage bag or a clean environment. It is important that all residual moisture dries. Do not store parts in an airtight container/bag.

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2a

or

Cover all parts, except the tubing, with water and boil for five minutes. If there is visible milk, condensation or residue in the tubing, follow step 2 in chapter 5.2.

2b

Use Quick Clean bags* in the microwave in accordance with the instructions. * Accessories available for order: see chapter 11. For more information, see www.medela.com

5.4 Breast pump – Cleaning and disinfection Clean and disinfect the pump as needed.

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2

To clean the breast pump, wipe the housing with a clean, damp (not wet) cloth. You may use drinking-quality water and basic washingup liquid or a non-abrasive detergent.

To disinfect the breast pump, wipe the pump housing with a clean, damp (not wet) cloth. You may use an alcoholbased disinfecting agent.

6. Preparing for pumping 6.1 Card and cord protector

Warning

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l For chapter 6.2 Mains operation: Use only the power cord that comes with the Symphony. l Make sure the voltage of the power cord is compatible with the power source.

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Info

l U se the pump only with the appropriate program card (Symphony Standard or Symphony PLUS). Optional for pump with battery: l T he built-in battery must be charged for 12 hours on receipt of the device. l The pump can be used during charging. l If the pump is to remain unused for a long time, charge the battery every two months (for 12 hours each time). l The optimum service life of the battery is ensured if it is not fully discharged on a regular basis or if the pump is charged while not in use. Pumping time (fully-charged battery)

approx. 60 min.

Charging time (for full charge)

12 hours

To remove, unscrew the card and cord protector and slide it out of the guide rail.

6.2 Mains operation 1

Insert the power cord into the power socket on the back of the pump.

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2

3

Insert the cord into the card and cord protector in a loop around the pin.  Make sure there is enough play to plug the cord in.

Push the card and cord protector over the guide rail on the back until it stops. Tighten the screw.

6.3 Changing the program card 2

1

Plug the power cord into the mains socket.

As soon as the card compartment is revealed, the card can be removed and replaced or changed.

6. Preparing for pumping Caution

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l Wash hands thoroughly (at least one minute) with soap and water before touching the breast, the clean pump parts and clean pump set. Dry your hands with a fresh towel or a single-use paper towel.

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Note

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l Use Medela original accessories only. l Check pump set parts for wear or ­d amage before use. Replace damaged or worn parts. l All parts must be completely dry before use.

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6.4 Assembling the pump set

Info

Carefully push the breast shield onto the connector. Choose a breast shield size that suits your needs. ➙S  ee chapter 7.1 to choose the right size.

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l Carry out all the steps with care and assemble the pump set correctly. Otherwise a good vacuum may not be achieved.

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

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2

3

Place the white membrane in a horizontal position on the yellow valve head. Push the knob on the membrane’s back into the smallest hole of the valve head until it engages.

Push the valve head and membrane onto the connector.  Position the valve head sideways.

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6

Insert the tubing into the corresponding opening in the connector.

Place the protective membrane with the round side up onto a flat surface. Push the cap into the membrane until it engages. Insert the tubing adapter into the opening in the membrane cap.

6. Preparing for pumping 22

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l Always close the lid when pumping. The lid keeps the membrane cap pushed down to prevent a loss of vacuum that could occur if the membrane cap came off.

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

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Close the lid.