medela Pump In Style Double Electric Breast Pump Instructions

medela Pump In Style Double Electric Breast Pump

Important safety information

READ ALL INSTRUCTIONS BEFORE USING THIS PRODUCT.

The defined signal words identify all instructions that are important to safety. Failure to observe these instructions can lead to injury or damage to the breast pump or yourself. When used in conjunction with the following words, the defined signal words stand for When using electrical products, especially when children are present, basic safety precautions should always be followed.

WARNING
Can lead to serious injury or death.

To avoid fire, electric shock, or serious burns:

• Do not leave the product unattended when plugged into an electrical outlet.
• Always unplug electrical products immediately after use.
• Do not place or store product where it can fall or be pulled into a tub or sink.
• Do not place or drop into water or other liquid.
• Never operate this product if it has a damaged cord or plugs, if it is not working properly, if it has been dropped or damaged, or dropped into water.
• Never drop or insert any object into any opening or tubing.
• Do not use outdoors, or operate where flammable products, like aerosol (spray), are being used or where oxygen is being administered.
• Always inspect the power adaptor and battery pack wires before use for damaged or exposed wires. If damage is found, immediately discontinue the use of a power adaptor or battery pack and call Medela Customer Service at 1-800-435-8316.
• The breast pump and detachable components are not heat-resistant: keep away from heated surfaces or open flames.
• Do not use near-flammable materials.
• Do not use an electrical outlet that has been exposed to water or other liquids.
• Do not use it while bathing or showering.
• Do not run water over the breast pump.
• If a device has been exposed to water or other liquids, do not touch it, unplug the device from the electrical outlet, turn it off, and contact the manufacturer.

WARNING
Can lead to serious injury or death.

To avoid health risks and reduce the risk of severe injury:

• This product is intended for use by a single user only and should not be shared between users.
• Do not use the pump while operating a moving vehicle.
• Inspect all appropriate pump components before each use.
• Do NOT continue pumping for more than 2 consecutive pumping sessions if no milk is expressed.
• Use the product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer.
• Pumping while sleeping could result in tissue damage.
• This device cannot be serviced or repaired. Do not repair yourself. Do not modify the device or parts.
• Never use a damaged device. Replace damaged or worn parts.
• Before each use visually inspect the individual components for cracks, chips, tears, discoloration, or deterioration. If damage to the device is observed, please discontinue use until the parts have been replaced.
• Only use Medela-recommended parts with your breast pump.
• Pumping can induce labor. Do not pump until after giving birth. If you become pregnant while breastfeeding or breastfeeding, consult with a licensed healthcare professional before continuing.
• If irritation or discomfort occurs, discontinue use and see a doctor.
• If 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 your baby through your breast milk.
• Clean and sanitize all parts that come into contact with your breast and breast milk before first use.
• Wash all parts that come into contact with your breast and breast milk after every use.
• Close supervision is necessary when this product is used near children or persons with disabilities to prevent strangulation by the tubing or power adaptor cord.

CAUTION
Can lead to minor injury.

• Do not wrap the cord around the power adaptor body.
• Use only the breast pump battery pack that comes with the breast pump.
• Plug the power adaptor into the breast pump first and then into the wall socket.
• Never put the breast pump in water or a sterilizer, as you can cause permanent damage to the breast pump.
• Do not attempt to remove the breast shield from your breast while pumping. Turn the breast pump off and break the seal between your breast and breast shield with your finger, then remove the breast shield from your breast.
• If pumping is uncomfortable or causing pain, turn the unit off, break the seal between the breast and the breast shield with your finger, and remove the breast shield from your breast.
• Contact your health care professional or breastfeeding specialist if you can express only minimal or no milk or if the expression is painful.
• While some discomfort may be felt when first using a breast pump, using a breast pump should not cause pain. For assistance with correct breast shield sizing and comfort please visit MedelaBreastShields.com (U.S.) or Medela.ca/BreastShields (Canada) or see a lactation consultant/breastfeeding specialist.
• Do not try to express with a vacuum that is too high and uncomfortable (painful). The pain, along with potential breast and nipple trauma, may decrease milk output.
• Make sure the tubing is not kinked or pinched while pumping.
• Do not hold the pump kit by the bottle. This can lead to blockage of the milk ducts and engorgement.
• Using a breast pump on an aircraft is not recommended. The cabin pressure may affect the breast pump’s performance.
• Wash hands thoroughly with soap and water before touching the breast pump, kit, and breasts, and avoid touching the inside of bottles or lids.
• Separate and wash all parts that are exposed to breast milk immediately after use. This will help remove breast milk residue and prevent the growth of bacteria.
• Always inspect breast shields, connectors, membranes, bottles, lids, and tubing before use for cleanliness. Contact Medela Customer Service if cleaning does not resolve the issue.
• Only use drinking-quality tap or bottled water for cleaning your breast pump and parts.

CAUTION
Can lead to minor injury.

• Do not store wet parts as mold may develop.
• Do not run the pump with wet tubing. Doing so may damage the breast pump.
• If you are experiencing discomfort at the base of the nipple due to rubbing your breast tissue against the breast shield tunnel, the use of a lubricant such as lanolin may be beneficial. For assistance with correct breast shield sizing and comfort please visit MedelaBreastShields.com (U.S.) or Medela. ca/BreastShields (Canada) or see a lactation consultant/breastfeeding specialist.

NOTICE
Can lead to material damage.

• Do NOT use antibacterial or abrasive cleaners/detergents when cleaning breast pump or breast pump parts.
• Plastic bottles and parts become brittle when frozen and may break when dropped.
• Bottles and 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.
• Do not use lithium batteries in the breast pump battery pack.
• Do not use the branded textile loop to wear the breast pump on the body.

Take a moment to read through this entire instruction manual before using this product for the first time.

PLEASE SAVE THESE INSTRUCTIONS.

Indications and contraindications for use

Indications for use
The Pump in Style® is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.

Contraindications
There are no known contraindications for use with this product.

Product Description/parts

Product Description
This breast pump is a personal-use electric breast pump that includes 2-Phase Expression® technology and is capable of single and double pumping.

Breast pump system parts
Not all parts listed are included with every Pump in Style® model. Refer to page 10 for a complete list.

All pictures shown in these instructions are for illustration purposes only. The actual product may vary due to local differences or product enhancement. Medela reserves the right to substitute any component with a replacement of equivalent performance.

Breast pump system parts (cont.)

• Breast pump model numbers
  • 101041359
  • 101041360
  • 101041361
  • 101041362

The model number (REF) can be found near the UPC on the package your breast pump came in.

Battery pack
1x included with model numbers 101041360, 101041361, and 101041362.

Bottles
4x bottles included with model numbers 101041359, 101041361, and 101041362. 2x bottles included with model number 101041360.

Bottle stands
1x bottle stand included with model number 101041359. 2x bottle stands included with model number 101041361.

Breast pump
1x included with all model numbers

Breast pump bag
1x breast pump bag included with model numbers 101041359, 101041361, and 101041362.

Breast shields

• 2x 24mm PersonalFit™ PLUS breast shields with model number 101041360.
• 2x 21mm and 24mm PersonalFit PLUS breast shields with model number 101041359.
• 2x 21mm and 24mm PersonalFit Flex™ breast shields with model numbers 101041361 and 101041362.

Connectors and membranes
2x connectors and 2x membranes included with all model numbers.

Removable cooler bag
1x included with model numbers 101041361 and 101041362.

Ice pack
1x included with model numbers 101041359, 101041361, and 101041362.

Lids
4x lids included with model numbers 101041359, 101041361, and 101041362. 2x lids included with model number 101041360.

Manual breast pump
1x included with model number 101041359.

Power adaptor
1x included with all model numbers

Tubing
1x included with all model numbers

You must do the following before using your breast pump for the first time: Disassemble all parts & clean using your breast pump cleaning instructions. For additional cleaning guidelines see the Center for Disease Control website – https://www.cdc.gov/healthywater/hygiene/healthychildcare/infantfeeding/breastpump.html

Supplies needed

• Mild dish soap
• Clean wash basin
• Drinking-quality water
• Clean pot for boiling water

Parts to wash or sanitize

• Breast shields
• Breast milk bottles and lids
• Connector bodies
• Connector caps
• Membranes

How to take apart

After each use

Disassemble the individual parts (breast shield, connector, and breast milk bottle) as follows:

1. Remove the breast shield from the connector.
2. Open the back cap of the connector by squeezing both flaps and swiveling the cap upwards.
3. Remove the membrane from the connector body.
4. Separate the breast milk bottles and lids.

How to wash (before first use and after each use)
Washing is important for hygiene and serves to clean the surfaces of the parts by physically removing contamination. Wash the parts either by hand or in a dishwasher.

Do not place the parts directly in the kitchen sink for rinsing and washing. Use a dedicated wash basin for infant feeding items.

1. Rinse the disassembled parts, except for the tubing, with cold, clear drinking-quality water.
2. Soak with warm soapy water for 5 minutes and wash with a clean, unused dishcloth. Use a commercially available dish soap, preferably without artificial fragrances and coloring (pH neutral).
3. Rinse the parts with cold, clear drinking-quality water.
4. Store dry parts when not in use. Do NOT store wet parts.
5. Place the disassembled parts, except for the tubing, on the top rack or in the cutlery section. Use a commercially available dishwashing detergent.
6. Store dry parts when not in use. Do NOT store wet parts. Useful information

  * If using the dishwasher, parts may become discolored. This will not impact the function of the parts.

How to sanitize (before first use and once per day)
Sanitizing is important for hygiene and serves to kill living organisms, such as bacteria or viruses. Boil the parts either on the stovetop or use Quick Clean™ microwave bags.

1. Cover the disassembled parts, except for the tubing, with water and boil for 10 minutes.
2. Allow the water to cool and gently remove parts from the water with tongs.
3. Place parts on a clean surface and /or towel and allow parts to air dry.
4. Store dry parts when not in use. Do NOT store wet parts.
5. Use Quick Clean* bags in the microwave according to the instructions on the bags. (sold separately)
6. Place parts on a clean surface and /or towel and allow parts to air dry.
7. Store dry parts when not in use. Do NOT store wet parts.

  * Do NOT clean tubing in a micro-steam bag.
  * Refer to local websites/shops for availability in your country.

Cleaning the breast pump (as needed)

Supplies needed:

• Clean cloth and towel
• Drinking-quality water

Parts needed

• Breast pump

1. Turn the breast pump off.
2. Unplug the breast pump from the power source.
3. Wipe the breast pump with a clean, damp cloth and dry it with a clean towel.

Cleaning the tubing
Normally, cleaning of the tubing is not necessary. Only if condensation is present is it necessary to wash the tubing as described in these instructions.

Supplies needed

• Drinking-quality water
• Mild dish soap

Parts needed

• Tubing

Useful information

• Inspect the tubing. If you find condensation in the air tube, wash and dry it immediately or replace the tubing. If you see breast milk in the tubing do not attempt to wash or clean the tubing. Instead, contact Medela Customer Service.

Washing the tubing

1. Rinse the tubing by pouring cool water into both short tubing ends until it flows out of the long tubing end.
2. Wash the tubing in warm, soapy water.
3. Rinse the tubing with clear water.

Drying the tubing

1. Shake out any water droplets.
2. Hang the tubing to air dry.
3. Make sure that the tubing is completely dry before using it.

Putting together your breast pump kit

Parts needed:

• Breast pump
• Tubing
• Breast shields
• Breast milk bottles and lids
• Connector bodies
• Connector caps
• Membranes

NOTICE
Can lead to material damage.

To prevent damage to the breast pump all components must be completely dry before use.

1. Wash hands thoroughly.
2. Carefully insert the (dark yellow) membrane with the flap into the opening of the connector. Æ Make sure that the membrane forms a seal around the edge of the connector.
3. Close the lid of the connector until you hear a click.
4. Screw the connector onto the bottle.
5. Carefully push the breast shield into the connector body. Æ Choose a breast shield size that suits your needs. For proper sizing see MedelaBreastShields.com (U.S.) or Medela.ca/BreastShields (Canada).
6. The oval breast shields can be rotated~ (360°) and placed in the desired position to have the most comfortable fit for you.
7. Insert one of the short ends of the tubing into the opening of the connector lid.
8. Insert the long end of the tubing into the breast pump as far as it will go.

How to single-pump

1. Insert the unused tubing end into the tubing holder.
   • Correctly assembled system (for single pumping).

How to double pump

1. Assemble the second breast pump kit, see page 16.
   • Correctly assembled system (for double pumping).

Putting together your breast pump kit (cont.)

Powering your breast pump

1. Power adaptor (included with your breast pump)
2. Battery pack (included with some models see section 3 for detailed contents, also sold separately)
   • You will need a total of 8 AA rechargeable batteries or alkaline batteries.
   • Slide off both battery covers. One cover on each side of the battery pack.
   • Place the negative (-) end of the battery against the front of the spring by pushing the battery in and down in one motion until the battery snaps into place. The positive (+) end of the battery should be near the positive sign on the battery pack.

Operating your breast pump

Glossary
2-Phase Expression® technology – research-based technology that mimics a baby’s natural nursing rhythm.
Stimulation Phase – fast sucking/pumping rhythm to stimulate the milk ejection reflex and to start the milk flowing.

Let-down – when your milk starts to flow.
Expression Phase – slower sucking/pumping rhythm for gentle and efficient milk removal as quickly as possible.
Maximum Comfort Vacuum™ – the highest vacuum level where a mother feels comfortable during pumping. It is different for every mother.

Get ready to pump

1. Check to see if you are using the correct size breast shield. Visit MedelaBreastShields.com (U.S.) or Medela.ca/BreastShields (Canada) for more information.
2. Wash hands thoroughly.
3. Connect your assembled breast pump kit to the tubing port on the top of the breast pump.
4. Make sure that the breast pump kit is connected and positioned properly.
5. Place the breast shield on the breast so that the nipple is properly centered in the tunnel.
6. Hold the breast shield and connector onto your breast with your thumb and index finger.
7. Support your breast with the palm of your hand.

Expressing your milk

After pumping
If you don’t press any buttons for 30 minutes, the pump will shut off on its own.

Prepare your breast milk for storage

1. Use the bottle stand (if available) to prevent the bottle from tipping over.
2. For information on storing your breast milk, visit BreastMilkGuidelines.com (U.S.) or Medela.ca/Breastfeeding/Moms-Journey/Storing-and-Thawing-Breast-Milk (Canada).
3. Remove tubing from the connector lid and breast pump.
4. Store tubing in a clean bag/container.

• Do not wrap tubing around the breast pump.

Finding your Maximum Comfort Vacuum™
Maximum Comfort Vacuum is the highest vacuum level where pumping still feels comfortable.

1. Once you are pumping in the Expression Phase, increase the vacuum with the ( + ) button until pumping feels slightly uncomfortable (not painful).
2. Then decrease the vacuum slightly with one press of the ( – ) button.

Useful information

• Stimulation should be at a comfortable vacuum level, pumping at a level that is too high is not necessary.
• Reassess your Maximum Comfort Vacuum throughout your pumping experience. It can change throughout each stage of lactation.

Resources for you

Helpful resources to support you throughout your breast milk feeding journey.

• Visit our website for helpful videos. MedelaVideos.com (U.S.) or youtube.com/channel/UCXu0hfQ0z-B1RNyS-2zKcSQ (Canada)
• Choosing the right breast shield size can impact your breast milk supply. Find out why and get help choosing the right size. MedelaBreastShields.com (U.S.) or Medela.ca/breastshields (Canada)
• Complement your breastfeeding journey with our free, personalized, award-winning app, designed to help you achieve your goals. Track baby’s key activities, log nursing and pumping details and get access to breastfeeding tips. Available on Android and iOS devices.
  • MyMedelaApp.com (U.S.) or Medela.ca/breastfeeding/moms-journey/mymedela (Canada)
• Learn more about storing your breast milk. BreastMilkGuidelines.com (U.S.) or Medela.ca/breastfeeding/moms-journey/storing-and-thawing-breast-milk (Canada) or Office On Women’s Health https://www.womenshealth.gov/breastfeeding/pumping-and-storing-breastmilk

An exclusive place for you to find the right information, tools, and service, delivered to you at the right time. Join now to get access to breastfeeding tips, support, and deals for free! Only available in the United States. MedelaMomsRoom.com

An exclusive place for you to find the right information, tools, and service, delivered to you at the right time. Join now to get access to breastfeeding tips, support, and deals for free! Only available in the United States. MedelaMomsRoom.com

Whether it’s your first latch or you have been breastfeeding for months, utilize these helpful solutions to keep you on the path of providing breast milk to your baby. Guidance MedelaBreastfeedingUS.com/Breastfeeding- Guide (U.S.) or Medela.ca/breastfeeding/moms-journey (Canada)

Troubleshooting

The breast pump generates no vacuum (motor not working) after you press the On/Off button| • Make sure that the breast pump is attached to a power source.

• Try using the battery pack If the pump turns on with the battery pack, then you may have a faulty power adaptor (replace power adaptor).

• If it still doesn’t work, contact Medela Customer Service.

There is low or no suction| • Make sure that all breast pump kit components are clean and dry and that connections are secure.

• Make sure the membranes are placed in the connector caps correctly and the connector caps are shut tightly.

• Make sure the breast pump shields are pushed into the connector caps tightly.

• While pumping, make sure the breast shields form a complete seal around the breast.

• When single pumping, make sure that the unused tubing end is correctly plugged into the tubing holder.

• If suction does not improve, contact Medela Customer Service.

The breast pump exterior got wet| • Unplug the breast pump from the power source and turn it off.

• Dry off the outside of the breast pump.

The breast pump has been submerged in water| • Unplug the breast pump from the power source.

• Contact Medela Customer Service.

If you have not resolved the problem with your breast pump or you have more questions, please contact Medela Customer Service at 800-435-8316.

Disposal

The unit is made of various metal and plastics. Before disposal, the device is to be rendered unusable and it must not be disposed of as unsorted municipal waste by local regulations. Use your local return and collection system for waste electrical and electronic equipment. Improper disposal may have harmful effects on the environment and public health. Through the Medela Recycles program, Medela LLC provides U.S.-based customers the option to properly recycle their electric breast pump after they’ve finished their breastfeeding journey. For information on how to recycle your pump visit MedelaRecycles.com. All other breast pump kit components (connectors, breast shields, tubing, bottles, membranes, and cooling elements) can be disposed of in your waste management recycling container at your home. Cooler bags and other soft-good items are not recyclable.

Warranty

This product is warranted by Medela to the original retail purchaser to be free from defects in material and workmanship for one year for the pump mechanism (90 days for parts and detachable components) from the date of purchase. Warranty can only be claimed in the country of purchase. In the event of a defect, Medela will repair or, at Medela’s option, replace this product, without charge for such replacement, parts, or labor. Purchaser shall bear all expenses for returning this product to Medela. This warranty does not apply to any product used commercially or which has been subjected to misuse, abuse, or alteration.

ANY AND ALL IMPLIED WARRANTIES, INCLUDING THE WARRANTY OF MERCHANTABILITY, ARE LIMITED TO A DURATION OF 1 YEAR FROM THE DATE OF PURCHASE. SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY ALSO HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE.

For questions regarding this warranty or instructions on making a warranty claim, please call Medela Customer Service (toll-free) at 1-800-435-8316. All returns must be sent with a Return Authorization Number from Medela, with your dated bill of sale or other proof of purchase and a brief statement of the problem to the following address: Medela LLC – Returns, Door 4501 1101 Corporate Dr. McHenry, IL 60050

• ATTENTION: RETURNS Medela Canada 4160 Sladeview Crescent Unit #8 Mississauga, ON L5L 0A1
• ATTENTION: RETURNS info@medela.ca

Meaning of symbols

Reference

1. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part
2. General requirements, Clause 5.1.1 Manufacturer
3. EN 50419, Marking of Electrical and Electronic Equipment by Article 11(2) of Directive 2002/96/EC (WEEE).
4. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 20 Type BF applied parts
5. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.3 Symbol 2 IP Code IEC 60529:1989+A1:1999+A2:2013, Degrees of protection provided by enclosures (IP Code)
6. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.1.3 Manufacturing Date / ISO 7000-2497, Graphical symbols for use on equipment, Date of manufacture
7. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 9 Class II equipment
8. IEC 60417-5957, Graphical symbols for use on equipment, For Indoor use only
9. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 4 Alternating current
10. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for Basic Safety and Essential Performance, Table D.1 Symbol 1 Direct current
11. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 29 Stand-by
12. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.1.6 Article number / ISO 7000- 2493, Graphical symbols for use on equipment, Catalogue number
13. Code of Federal Regulations, Title 47, Part 15b / 15 c
14. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.1.6 Article number / ISO 7000- 2493, Graphical symbols for use on equipment, batch code
15. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.1.7 Serial number / ISO 7000-2498, Graphical symbols for use on equipment, Serial number
16.  ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.3.1, Fragile, handle with care / ISO 7000-0621, Graphical symbols for use on equipment, Fragile, handle with care
17. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.3.2 Keep away from sunlight / ISO 7000-0624, Graphical symbols for use on equipment, Keep away from sunlight
18. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.3.4, Keep away from rain / ISO 7000-0626, Graphical symbols for use on equipment, Keep away from rain
19. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied, Part 1: General requirements, Clause 5.3.7 Temperature Limit / ISO 7000-0632, Graphical symbols for use on equipment, Temperature Limit
20. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.3.8 Humidity Limit / ISO 7000-2620, Graphical symbols for use on equipment, Humidity Limit
21. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied, Part 1: General requirements, Clause 5.3.8 Humidity Limit / ISO 7000-2620, Graphical symbols for use on equipment, pressure Limit
22. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied, Part 1: General requirements, Clause 5.4.3 Consult instructions for use/ ISO 7000-1641, Graphical symbols for use on equipment, consult instructions for use.

EMC technical description

The breast pump needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the instructions for use. Portable and mobile RF communications can affect the breast pump.

NOTICE Can lead to material damage.

FCC STATEMENT

This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions:

• This device may not cause harmful interference
• This device must accept any interference received, including interference that may cause undesired operation.

This equipment has been tested and found to comply with the limits for a Class B Digital Device, under part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used per the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Guidance and manufacturer’s declaration – electromagnetic emissions

This breast pump is intended for use in the electromagnetic environment specified below. The customer or the user of the breast pump should ensure that it is used in such an environment.
Emission tests| Compliance| Electromagnetic environment – guidance

RF Emissions CISPR 11

|

Group 1

| The breast pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11|

Class B

|

The breast pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

|

Class A

Voltage fluctuations/flicker emissions

IEC 61000-3-3

|

Pst < 1.0

WARNING : This breast pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, this breast pump should be observed to verify normal operation in the configuration in which it will be used.

EMC technical description
Guidance and manufacturer’s declaration – electromagnetic immunity This breast pump is intended for use in the electromagnetic environment specified below. The customer or the user of the breast pump should ensure that it is used in such an environment. The Pump in Style® breast pump has no essential performance but was tested for immunity to electromagnetic disturbances and passed using the following criteria:

1. No visible change in the operation of the breast pump.
2. The breast pump changes settings, but returns automatically to previous settings.
3. The breast pump changes settings, but can return to previous settings by intervention of the user.

Guidance and manufacturer’s declaration – electromagnetic immunity (cont.)|  |
---|---|---
 |  |  |  |
Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment

– guidance

|  |
 |

Electrostatic discharge (ESD) IEC 61000-4-2

| +/- 2kV, +/- 4kV,

+/- 6 kV, +/- 8kV contact discharge

+/- 2kV, +/- 4kV,

+/- 6 kV, +/- 8kV,

+/- 15 kV

air discharge

| +/- 2kV, +/- 4kV,

+/- 6 kV, +/- 8kV contact discharge

+/- 2kV, +/- 4kV,

+/- 6 kV, +/- 8kV,

+/- 15 kV

air discharge

| ****

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

|
Electrical fast transient/burst IEC 61000-4-4| ± 2 kV

100 kHz repetition frequency

| ± 2 kV

100 kHz repetition frequency

| Mains power quality should be that of a typical commercial or hospital environment.|
Surge

IEC 61000-4-5

| ± 0,5 kV, ± 1 kV

Line-to-line

| ± 0,5 kV, ± 1 kV

Line-to-line

| Mains power quality should be that of a typical commercial or hospital environment.|
Voltage dips, short interruptions, and voltage variations on

power supply input lines IEC 61000-4-11

| ****

0 % UT; 0,5 cycle

At 0°, 45°, 90°,

135°, 180°, 225°,

270°, and 315°

| ****

0 % UT; 0,5 cycle

At 0°, 45°, 90°,

135°, 180°, 225°,

270°, and 315°

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the breast pump requires continued operation during power mains interruptions, it is recommended that the breast pump be powered from an uninterruptible power supply or a battery.|

Power frequency (50/60 Hz)

magnetic field IEC 61000-4-8

| ****

30 A/m, 50 or

60 Hz

| ****

30 A/m, 50/60 Hz

| It may be necessary to position the breast pump further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field

should be measured in the intended installation location to ensure that it is sufficiently low.

|
NOTE: UT is the a.c. mains voltage before application of the test level.|
Guidance and manufacturer’s declaration – electromagnetic immunity

This breast pump is intended for use in the electromagnetic environment specified below. The customer or the user of the breast pump should ensure that it is used in such an environment.
Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| ****

3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz

and 80 MHz

80% AM at 1 kHz

10 V/m (minimum)

80 MHz – 2,7 GHz

80 % AM at 1 kHz

| ****

6V

10 V/m (minimum)

| ****

Portable and mobile RF communications equipment should be used no closer to any part of the breast pump, including cables, than the recommended separation

distance calculated from the equation applicable to the frequency of the transmitter.

Recommend separation distance d = 1,2√P

d = 1,2√P 80 MHz – 800 MHz d = 2,3√P 800 MHz – 2.7 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the

transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,  should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol.

• Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
• Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
  • Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the breast pump is used exceeds the applicable RF compliance level above, the breast pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the breast pump.
  • Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Table of frequencies of portable and mobile transmitters for which the recommended separation distance is 30 cm (12 inches):

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the breast pump including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical specifications

The operating life of this breast pump is defined to be approximately three 15-minute sessions per day, for one year. The operating life for the breast pump kit is 6 months.

Materials touching skin or coming in contact with milk

• Breast shield : Polypropylene, thermoplastic elastomer
• Connector: Polypropylene, silicone
• Bottle: Polypropylene
• Lid: Polypropylene

All parts that come in contact with breast milk are not made with BPA (Bisphenol A).

1. Maximum Vacuum in Expression (when single or double pumping).
2. Under typical conditions, the Pump In Style® breast pump is capable of providing vacuum levels from -50 to -240 mmHg. Under the foreseeable limits of use conditions which produce peak vacuum of the greatest magnitude, the pump could produce vacuums of -295 mmHg.

USA
Medela LLC 1101 Corporate Drive McHenry, IL 60050 USA 800-435-8316 or 815-363-1166 customer.service@medela.com medela.com Distributed by/Distribuido por/Distribuée par:

Canada
Medela Canada Inc. 4160 Sladeview Crescent, # 8 Mississauga, ON, L5L 0A1

Canada
800-435-8316 or 905-608-7272 info@medela.ca  medela.ca

Content appearance may vary from pictures.

• Medela wordmark and logo, Pump In Style, 2-Phase Expression, The Moms’ Room, MyMedela, and Symphony PLUS are registered with the U.S. Patent and Trademark Office. Tender Care, PersonalFit, PersonalFit Flex, Maximum Comfort Vacuum, Quick Clean, and Mother’s Milk, Everyday Amazing are trademarks of Medela.

References

• Breastfeeding & Pumping
• Homepage Medela | Medela
• Your breastfeeding journey | Medela
• Your breastfeeding journey | Medela
• Allaitement maternel | Solutions et informations | Medela | Medela
• Votre expérience d'allaitement | Medela
• Votre expérience d'allaitement | Medela
• Breastfeeding & Pumping
• Breastfeeding & Pumping
• Breastfeeding & Pumping
• Breastfeeding & Pumping
• Breastfeeding & Pumping
• cdc.gov/healthywater/hygiene/healthychildcare/infantfeeding/breastpump.html
• Breastfeeding | Office on Women's Health

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