medela Symphony Double Electric Breast Pump Instructions

Breast pump –
for healthcare professionals Instructions for use

Illustrated items or instruction steps are marked with the figure and detail number (e.g. 2-01).

Fold these pages out.

Important safety information

For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has  occurred, please report it to the manufacturer and/or its authorised representative and to your national authority.
Please read all instructions before using this product.
Keep these instructions for future reference.
Warnings identify all instructions that are important for safety. Failure to observe these instructions can lead to personal injury or damage to the product.
The following symbols and signal words show the significance of the warnings:

safety.

WARNING

To reduce the risk of electric shock:

• Plug the power cord into the breast pump first and then into the wall socket.
• Keep the device dry. Never immerse in water or other liquids.
• Do not spray or pour liquid directly onto the pump unit.
• Do not place or store the device where it can fall or be pulled into a sink or tub.
• Do not use the breast pump while bathing or showering.
• Do not reach for any electrical device if it has fallen into water. Unplug immediately.

To avoid fire, electric shock or serious burns:

• The Symphony breast pump is not heat-resistant: keep away from radiators and open flames.

• Do not expose the pump unit to direct sunlight.

• Do not operate the Symphony breast pump where aerosol (spray) products are being used or where oxygen is being administered.

• Do not use the device in the presence of a flammable anaesthetic mixture with air, or with oxygen or nitrous oxide.

• Do not thaw frozen breast milk, or 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 microwaving. Microwaving can also change the composition of breast milk.

• Only use the power cord that comes with the Symphony breast pump.

• Never 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.

• Always inspect power cord wires prior to use for damage or exposed wire. If any damage is found, immediately stop using the power cord. Contact the local Medela representative.

WARNING

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

To avoid health risk and reduce risk of injury:

• If problems or pain occur, consult a lactation consultant or breastfeeding specialist.
• Never use while pregnant, unless prescribed/advised by a physician, as pumping can induce labour.
• For mothers who are infected with Hepatitis B, Hepatitis C or Human Immuno-deficiency Virus (HIV): pumping breast milk will not reduce or remove the risk of transmitting the virus to the baby through breast milk.
• Inspect all components of the Symphony breast pump as well as all parts 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 dirt, mould or other contamination is visible.
• Replace mouldy, damaged or worn parts.
• There are no user-serviceable parts inside the Symphony pump unit. Repairs must only be performed by an authorised service agency. Do not attempt to repair the pump or parts by yourself.
• Only use the Symphony breast pump for its intended purpose as described in these instructions for use.
• Only use Medela original accessories.
• Do not modify any parts of the pump or the pump set.
• Do not use the Symphony breast pump while operating a motor vehicle.
• Do not drive whilst hands-free pumping.
• Never drop or insert any object into any opening or tubing.
• Do not use outdoors.
• Supervision is necessary when the Symphony breast pump is used in the vicinity of children.
• Portable and mobile radio frequency communications equipment can affect the Symphony breast pump.
• The Symphony breast pump needs special precautions regarding EMC (Electromagnetic Compatibility).
  Install and put into service according to the EMC information provided in these instructions for use.

CAUTION
To avoid risk of contamination:

• Wash 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.
• Do not use the Symphony breast pump while sleeping or overly drowsy.
• Only use drinking-quality tap or bottled water for cleaning.
• Do not store wet or damp parts as mould may develop.

To avoid health risk and reduce risk of injury:

• Only pump with the breast pump in an upright position.
• Pressing shields too firmly onto the breasts may affect the milk flow.
• Do not express with a vacuum that is too high and uncomfortable (painful). Pain, along with potential breast and nipple trauma, may decrease the milk output.
• 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.
• If pumping is uncomfortable or causing pain, turn the unit off, break the seal between breast and breast shield with a finger and remove the breast shield from the breast.
• Do not shorten the tubing between breast shield and pump.
• Do not use abrasive washing-up liquids/detergents when cleaning the breast pump, pump components or pump set parts.
• Never put the pump unit in water or in a steriliser, as this can cause permanent damage to the breast pump.
• Do not use Medela Symphony pump sets with non-compatible breast pumps.
• Do not use the Medela Symphony pump sets for any other purpose than expressing breast milk.

NOTICE

• Plastic bottles and component parts become brittle when frozen and may break when dropped.
• Also, 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 show signs of damage.

Intended purpose/indications and contraindications

Intended purpose
The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.
Indications for use
The Symphony breast pump is indicated to express and collect milk from the breasts of a lactating woman.
It is also indicated to initiate, build and maintain a mother’s milk supply to support the provision of human milk for infants who are not able to directly or effectively breastfeed (e.g. latch-on problems such as flat or inverted nipples, cleft  palate and prematurity). The breast pump removes milk from affected breast/s to alleviate the symptoms of engorgement and milk stasis as well as support the healing process of sore or cracked nipples and mastitis.
Contraindications
There are no known contraindications for the Symphony breast pump.

Product description

3.1 Symphony hospital breast pump and accessories
Medela’s Symphony hospital-grade breast pump is a multi-user breast pump with research-based pumping programs which were developed specifically to support mothers of preterm and term infants to initiate, build and maintain an adequate milk production.
The Symphony breast pump is provided with the Symphony PLUS program card, which contains two pump suction pattern programs.
INITIATION
TECHNOLOGY
The INITIATE program with Medela’s initiation technology
The INITIATE program mimics the irregular and more rapid sucking and pausing pattern of a term born infant in the first few days of lactation. This program is intended for use in the first few days after birth before secretory activation  to support pump-dependent mothers to initiate milk production.
The MAINTAIN program with Medela’s 2-Phase Expression technology
The MAINTAIN program mimics the term born infant’s sucking pattern during established lactation. This program is designed to optimise milk output after secretory activation to support mothers to build and maintain lactation.
Required accessories
Only operate the Symphony breast pump with Medela pump sets and milk bottles.
Pump sets and bottles are available as reusable or as disposable products.

Medela’s disposable products are intended for single-use or one-day use in hospitals, without a need for cleaning prior to first use.
Available reusable products:

• Symphony Hospital Multibox (25 reusable pump sets in sizes S or M)
  Available disposable products:

• Sterile single-use Symphony Pump Set (size M, L or XL)

• Ready-to-Use one-day Symphony Pump Set (size M, L or XL)

• Colostrum container (35 ml)

• Sterile single-use bottle (available sizes: 80 and 150 ml)

• Ready-to-Use single-use bottle (available sizes: 80, 150 and 250 ml)
  Optional accessories and other products to be used in combination
  Mobile stand for the breast pump, hard case for the pump unit, card and cord protector.
  Products may not be available in all countries. For further information about Medela products, visit www.medela.com and look for the location finder.

3.2 Symphony hospital breast pump – product parts
Refer to figure 1 on the foldout pages.
Pump:
1-01 On/off button
1-02 LCD display
1-03 Let-down button
1-04 Vacuum adjustment knob
1-05 Pump unit
1-06 Bottle holder
1-07 Card and cord protector
1-08 Socket for car connection cable
1-09 Power cord
1-10 Symphony PLUS program card

3.3 Reusable pump set and disposable pump set – product parts (applied parts)
Refer to figure ¢2 on the foldout pages.
Reusable pump set:
2-01 Breast shield
2-02 Connector and connector lid
2-03 Breast milk bottle (150 ml)
2-04 Multi lid
2-05 Membrane
2-06 Tubing
2-07 Symphony cap
Disposable pump set:
2-08 Breast shied
2-09 Tubing and Symphony cap
2-10 Connector with connector lid
2-11 Membrane
2-12 Disposable bottle

Information
All pictures shown are for illustration purpose only. Actual product may vary due to product enhancement.
Refer to the instructions for use provided with the Symphony pump sets for product description and instruction on handling.

Cleaning

CAUTION

• Unplug the breast pump before cleaning.
• These recommendations are not substitutes for official hospital procedures that may differ among institutions. Refer to hospital policy for cleaning of shared capital equipment.
• In the event of conflicting national cleaning and disinfection requirements, these shall prevail over the Medela recommendations.
• Surface disinfectant agents for medical devices will not cause mechanical damage to the Symphony breast pump.
• Follow the instructions provided by the supplier of the surface disinfectant agent.
• Provide personal protection for operators in accordance with the supplier’s instructions and safety data sheets.
• Check the suitability of the surface disinfectant agents for medical devices by reference to the supplier’s information and/or physical testing.

Breast pump – cleaning and disinfection
Clean and disinfect the breast pump as needed.

1. To clean the breast pump, wipe the pump housing with a clean, damp (not wet) cloth. Drinking-quality water and a basic washing-up liquid or non-abrasive detergent may be used.
2. To disinfect the pump, wipe the pump housing with a clean, damp (not wet) cloth that is impregnated with a surface disinfectant agent for medical devices. Medea recommends using an alcohol-based surface disinfectant agent.

Cleaning pump sets
Refer to the instructions for use provided with the Symphony pump sets for product description and instruction on handling.

Preparing for pumping

Refer to figure ¢3 on the foldout pages.
WARNING

• Only use the power cord that comes with the Symphony breast pump.
• Make sure the voltage of the power cord is compatible with the power source.

i Information
Optional for pump with battery:

• The built-in battery must be charged for 12 hours on receipt of the device.
• The pump can be used during charging.
• If the pump is to remain unused for a long time, charge the battery every two months (for 12 hours each time).
• The optimum service life of the battery is achieved 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 minutes
Charging time (for full charge): 12 hours

5.1 Installation of the program card. Installation of the card and cord protector (optional)
Installation of the program card:

1. The program card must be inserted in the card compartment on the back of the breast pump ( ¢ 3-01). Æ For more information on the use of the program card and the selection of the appropriate program, see section 6.2.

Installation of the card and cord protector (optional):

1. Insert the cord into the card and cord protector in a loop around the pin ( 3-02).
   Ensure that there is sufficient cord length to insert the power cord into the power socket in the back the pump.

2. Push the card and cord protector over the guide rail on the back until it stops and tighten the screw ( 3-03).

3. To remove, unscrew the card and cord protector and slide out of the guide rail ( 3-04).

5.2 Mains operation

1. Insert the power cord into the power socket on the back of the pump ( 3-05). Plug the power cord into the mains socket.

5.3 Assembling the Symphony pump set

CAUTION

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

NOTICE

• Use Medela original accessories only.
• Refer to instructions for use provided with the Symphony pump set for description and instruction on handling the pump set.

5.4 Connecting the pump set to the pump housing

1. Open the lid of the breast pump: press the oval button on the top of the Symphony pump and lift the handle ( 3-06).

2. 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 ( 3-07).
   3. Centre the tubing connector in the recess in the pump housing ( 3-07).
   i Information
   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.

3. Close the lid ( 3-08).

Expression

6.1 Selecting the correct Medela breast shield size
Make sure to use the correct breast shield size. It is an essential component of effective pumping, helping to optimise milk flow. For more information on breast shield sizing and other available sizes,
visit www.medela.com/fittingguide.
6.2 Selecting the right program
The Symphony breast pump is installed with the Symphony PLUS program card, which contains two pump programs. The goal of the INITIATE program is to initiate milk production. The MAINTAIN program is designed to build and maintain milk production.

Until secretory activation (milk coming in) or a maximum of 5 days:
Use the INITIATE program directly after birth until the mother has reached secretory activation:

• For fully pump-dependent mothers:
  This can be indicated by pumping at least 20 ml in total in each of her last three pumping sessions. If not all pumping volumes have been recorded, this can be indicated by other physiological markers of secretory activation, such as breast fullness.

• When the mother is breastfeeding and pumping:
  This can be indicated by other physiological markers of secretory activation, such as breast fullness OR
  Throughout the first five days. If milk production has not started after five days, change to the MAINTAIN program.
  After secretory activation (milk coming in):
  Use the MAINTAIN program after secretory activation:

• Once the mother has pumped at least 20 ml in total in each of her last three pumping sessions, OR

• Beginning on day six, whichever of the two options comes first.

6.3 Operation: INITIATE program
CAUTION

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

Refer to figure ¢1 on the foldout pages.

1. Press the on/off button ( 1-01) to switch on the breast pump.
   The display text shows “INITIATE press ”.

2. Press the “Let-down” button ( 1-03) within ten seconds.
   The display text will change to “INITIATE running”.

3. Set the maximum comfort vacuum (see section 6.5).
   The bullets on the display show the vacuum level. The more bullets, the stronger the vacuum.

4. The INITIATE program runs automatically for 15 minutes with stimulation, expression and pause phases Æ An acoustic signal indicates the end of the program. The display shows “Program complete“. The pump
   switches off automatically. It is important to complete the entire INITIATE program.

NOTICE

• Always disconnect the Symphony breast pump from the power source after expression.

6.4 Operation: MAINTAIN program
CAUTION

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

i Information

• If the pump has been running for 30 minutes without any manipulations (e.g. adjustment of the vacuum), the Symphony breast pump will automatically switch off.

Refer to figure ¢1 on the foldout pages.

1. Press the On/off button ( 1-01) to switch on the breast pump.
   The MAINTAIN program will automatically start with the stimulation phase after pressing the On/off button.

2. Set the maximum comfort vacuum (see section 6.5).
   The drops on the display show the vacuum level. The more drops, the stronger the vacuum.

3.  The pump will automatically switch to the expression phase after two minutes.

4. If the milk starts to flow sooner, press the Let-down button ( 1-03) to change to the expression phase.

5. Set the maximum comfort vacuum (see section 6.5).
   The bars on the display show the vacuum level. The more bars, the stronger the vacuum.

6. Continue pumping until the breast feels well drained and soft all over (Medela recommends a pumping time of at least 15 minutes).

7. Switch off the pump by pressing the on/off button ( 1-01).
   i Information

8. Press the “Let-down” button
   ( 1-03) to revert from the expression phase to the stimulation phase if necessary. If milk has not begun to flow after two successive stimulation phases, the mother should take a break and try again in 15 to 30 minutes. Also, she  could try breast massage and then pump using the expression phase.
   NOTICE

9. Always disconnect the Symphony breast pump from the power source after expression.

6.5 Set maximum comfort vacuum
Set the maximum comfort vacuum by rotating the vacuum adjustment knob ( ¢ 1-04).

1. First rotate to the right to increase the vacuum until there is a slight discomfort.
2. Then rotate to the left to reduce the vacuum until it is comfortable.

6.6 Expression by single pumping

i Information
Medela recommends double pumping.

• Double pumping saves time and increases the energy content of milk. Milk production may be increased and maintained long term.
• For single pumping, step 7 of section 6.7 can be ommitted.
• Do not kink the tubing during expression.
  1. Prepare one bottle and pump set for expression.
  2. Mount only one Symphony cap on the breast pump (see section 5.4).
  3. Continue as described in section 6.7 step 3 for double pumping.

6.7 Expression by double pumping
Refer to figures ¢1, 3, 4 on the foldout pages.

1. Prepare two bottles and pump sets for expression.
2. Mount the Symphony caps on the breast pump (see section 5.4) ( 3-07).
3. Place the breast shield on the breast so that the nipple is properly centred in the tunnel ( 4-01).
4. Hold the breast shield onto the breast with the thumb and index finger. Support the breast with the palm of the hand ( 4-01).
5. Switch the breast pump on with ( 1-01).
6. Proceed with the program selection (see sections 6.2, 6.3 and 6.4).
7. Place the breast shield of the second bottle on the other breast so that the nipple is properly centred in the tunnel ( 4-02).
8. Operate the pump as appropriate for the selected program (see sections 6.3 and 6.4).
9. When expression is finished, place the bottles in the stand or bottle holder in order to prevent the bottles from tipping over ( 4-03).
10. Close the bottles with the lid.

Troubleshooting and error codes

Troubleshooting

If the motor
is not running| Check whether mains power/battery is available.
Check that the device is switched on.
Check whether program card is inserted correctly in the card compartment on the back of the breast pump.
If there is low
or no suction| Assemble the pump set in accordance with the instructions in section 5.3.
Check whether all connections to the pump set and breast pump are secure.
Express in accordance with chapter 6. Make sure that the breast shield forms a complete seal around the breast.
Check that the pump set components are clean and not damaged.
Check that the pump set is correctly assembled according to section 5.3 and 5.4:
• Check that the ends of the tubing are firmly connected.
• Do not kink or trap the tubing during expression.
• All components must be completely dry prior to pumping.
If there is an
overflow| Place the pump set into the bottle holder.
Turn off the pump and unplug the power cord from the socket.
Use a damp (not wet) cloth to wipe the pump and membrane area.
If there is milk, condensation or visible residues in the tubing:
• For disposable pump set: Dispose of the pump set and replace with a new one
•  For reusable pump set: Dispose of the silicone tubing and replace with a new one.
Reprocess the remaining parts according to section 4.
When components are completely dry, reassemble breast pump and accessories set.

Error codes
The following table describes error codes that may be displayed indicating an issue with the unit, potential causes, and steps to correct the issue.

| Potential issues| Actions
---|---|---
Display
Invalid card| Program card is not a Symphony card Program was inserted incorrectly Program card is damaged and not working| •Check if the correct program card is being used
•Make sure that the card is positioned correctly
•Replace program card
No card| Program card is not inserted
Program card is not completely inserted| •Insert program card
•Push card all the way in
Battery low| Battery needs charging soon, will beep every 20 seconds (15 minutes of pumping time remaining from when the indication started)| •Make sure that the power cord is plugged into the back of the pump
Motor overload| Motor is drawing too much current| •Contact your local Medela representative if this happens repeatedly
Error| Potential fault in electronics of gear control| •Contact your local Medela representative if this happens repeatedly
Power fault| Potential fault in electronics of power supply| •Contact your local Medela representative if this happens repeatedly

Warranty, electrical safety and maintenance

Warranty
Three-year warranty for the unit from the date of purchase, excluding pump set and accessories. Six month warranty for the batteries. The manufacturer is not liable for any damage or consequential damage caused by incorrect operation, inappropriate usage or use by unauthorised persons. Routine checks, servicing and battery exchange may only be carried out by Medela-authorised personnel.
Electical safety
The engineering of the Medela Symphony breast pump has been verified by independent test institutes for compliance with the EN/IEC 60601-1 standard. Copies of such certificates may be obtained upon request.
Because of the method of construction used, Medela does not expect electrical safety to be affected at any time during the life of the product – provided that it is used properly in accordance with the intended purpose as well as these  instructions for use, and that the device is serviced and repaired at authorised service centres. There are no prescribed or recommended electrical safety checks or recurrent tests to be carried out.
Manufacturer’s information is provided in accordance with EN/IEC 62353 “Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment”.
Maintenance
Besides the cleaning procedure(s) described in chapter 4 and battery charging for pumps with optional batteries as described in chapter 5, there is no further maintenance required. Besides the inspection procedures described in chapter  1, e.g. visual signs of damage on pump or power cord, pump dropped or dropped into water, there are no further inspections required. As pointed out in chapter 1, service and repair must be performed only by an authorised service agency (centre) in full accordance with the Symphony Service Manual using original Medela spare parts mentioned therein. The service manual, wiring diagrams, and descriptions are available upon request from Medela.
Medela deems that the final production testing replaces on-site testing of the device before putting into service.
The service life of the device is seven years, internal batteries life included.

Disposal

Disposal of electrical and electronic equipment
The Symphony breast pump is made of metals and plastics and should be disposed of in accordance with the European directives 2011/65/EU and 2012/19/EU. Additionally, local guidelines must also be observed.
With the AC/DC versions, the electronic components and the rechargeable battery must be disposed of separately, in accordance with the local regulations. Please take care that you dispose of the Symphony and its accessories in  accordance with your local disposal guidelines.
User information for the disposal of electrical and electronic equipment
This symbol means that the electrical and electronic equipment must not be disposed of together with unsorted municipal waste. Correct disposal of this device protects and prevents possible damage to the environment or human health.  For more information about the disposal contact the manufacturer, your local caregiver or healthcare provider. This symbol is valid in European Union, UK and Switzerland. Please respect the relevant state laws and rules in your country  for the disposal of electrical and electronic equipment.

Electromagnetic compatibility (EMC)

The Symphony breast pump is EMC-tested in conformity with the requirements of IEC 60601-1-2.
WARNING

• The Symphony breast pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Symphony electric breast pump should be monitored to verify normal operation in the  configuration in which it will be used.
• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies can affect the Symphony electric breast pump and should be kept at a  distance of at least 30 cm from the equipment.
• Do not use other accessories than those specified or sold by the manufacturer as replacement parts for internal components as it may result in increased emissions or decreased immunity of the Symphony device.
  For technical details (English only) refer to section 13.1 in the appendix.

Technical specifications

References

• Medela Deutschland | Stillprodukte und medizinische Vakuumtechnologie | Medela
• Homepage Medela | Medela
• Medela Schweiz | Stillprodukte und medizinische Vakuumtechnologie | Medela
• Homepage Medela | Medela
• Breastfeeding & Pumping
• Medela | Breastfeeding products and medical vacuum technology | Medela
• Choosing your Medela breast shield size | Medela
• Stillen und Abpumpen
• Brusthaubengröße | So wählst du die richtige Brusthaubengröße | Medela
• Homepage Medela | Medela
• Allattamento al seno ed estrazione
• Breastfeeding & Pumping

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