medela 15400089 Pump In Style Hands-Free Collection Cups Instruction Manual

medela 15400089 Pump In Style Hands-Free Collection Cups

Product Information

The product is a Double Electric Breast Pump. It includes the following features:

• Hands-free Collection Cups
• Breast shield 21 mm (2pcs) (Applied part)
• Breast shield 24 mm (2pcs) (Applied part)
• Tubing
• Battery pack
• O-ring
• Yellow membrane (2pcs)
• Alignment tab Valve
• Outer shell (2pcs)
• Pouring spout
• Tubing connection port
• Breast pump
• Power adaptor

Product Usage Instructions

1. Wash hands thoroughly with soap and water before touching the breast pump, the Hands-free Collection Cups, and breasts. Dry hands with a clean towel.
2. Confirm that the O-ring is applied to the breast shield you are using.
3. Assemble the valve of the yellow membrane on the front of the breast shield.
4. Align the disc of the yellow membrane on the designated circular slot using the alignment tab at the top. Press around the edges to ensure it is fully assembled.
5. Insert the pouring spout into the opening on the shield.
6. Push the outer shell and breast shield together tightly, ensuring it is fully sealed all the way around until you hear a snapping sound.
7. Insert one of the flat ends of the tubing into the opening of the collection cups.
8. Insert the long round end of the tubing into the breast pump as far as it will go.

Useful Information

The 24mm breast shield contains the O-ring. If you would like to use a different size breast shield, disassemble the already applied O-ring from the 24 mm breast shield starting by pulling out the bottom tab from the breast shield. To reassemble the O-ring to a different size or replace the O-ring, stretch it over the outer edge of the breast shield. Ensure it goes on with the ridges facing outwards. Press along the groove, checking that it is in place all the way around.

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.

Indications for use

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

Contraindications

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

IMPORTANT SAFETY INFORMATION

WARNING: Can lead to serious injury or death.

To avoid fire, electric shock, or serious burns:

• Do not leave product unattended when plugged into an electrical outlet.
• Always unplug electrical product 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 plug, 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 power adaptor and battery pack wires prior to use for damage or exposed wire. If damage is found, immediately discontinue use of 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 while bathing or showering.
• Do not run water over breast pump.
• If a device has been exposed to water or other liquids, do not touch, unplug the device from electrical outlet, turn off and contact manufacturer.
• 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.
• 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 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. In the event that 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 breast pumping, 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 prior to first use.

CAUTION: Can lead to minor injury.

• Do not wrap 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 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 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 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 see a lactation consultant / breastfeeding specialist.
• Do not try to express with vacuum that is too high and uncomfortable (painful). The pain, along with potential breast and nipple trauma, may decrease milk output.
• Make sure tubing is not kinked or pinched while pumping.
• 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 breast pump, kit and breasts, and avoid touching the inside of collection cups.
• Separate and wash all parts that are exposed to breast milk immediately after use. This will help remove breast milk residue and prevent growth of bacteria.
• Always inspect breast shields, collection cups, membranes and tubing prior to 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.
• Do not store wet or damp parts as mold may develop.
• Do not run 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 of your breast tissue against the breast shield tunnel, 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 see a lactation consultant / breastfeeding specialist. Use the collection cups only for its intended use as described in these instructions for use.
• If tubing becomes moldy, discontinue use and replace tubing.
• Do not microwave or boil breast milk. Microwaving can cause severe burns to baby’s mouth from hot spots that develop in the milk during microwaving (microwaving or boiling can also change the composition of breast milk).

NOTICE: Can lead to material damage.

• Do NOT use antibacterial or abrasive cleaners / detergents when cleaning breast pump or breast pump parts.
• Component parts become brittle when frozen and may break when dropped.
• Component parts may become damaged if mishandled, e.g. dropped, over-tightened, or knocked over.
• Take appropriate care in handling components.
• Do not use the breast milk if components become damaged.
• Do not use lithium batteries in the breast pump battery pack.
• Handle batteries with care.
• Do not use the branded textile loop to wear the breast pump on the body.

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 features

PUTTING TOGETHER YOUR BREAST PUMP KIT

NOTICE: Can lead to material damage.

Refer to the breast pump Quick Start guide for detailed cleaning instructions. To prevent damage to the breast pump all components must be completely dry before use.

1. Wash hands thoroughly with soap and water before touching your breast pump, parts of the Hands-free Collection Cups and breasts. Dry your hands with a clean towel.
2. First, confirm that the O-ring is applied to the breast shield you are using.
3. Assemble the valve of the yellow membrane on the front of the breast shield.
4. Align the disc of the yellow membrane on the designated circular slot using the alignment tab at the top to ensure that it is at the right place. Press around the edges to make sure it is fully assembled.
5. Insert the pouring spout into the opening on the shield.
6. Push the outer shell and breast shield together tightly, ensuring it is fully sealed all the way around until you hear a snapping sound.
7. Insert one of the flat ends of the tubing into the opening of the collection cups.
8. Insert the long round end of the tubing into the breast pump as far as it will go.

Useful information

• The 24mm breast shield contains the O-ring. If you would like to use a different size breast shield disassemble the already applied O-ring from the 24 mm breast shield starting by pulling out the bottom tab from the breast shield.
• To reassemble the O-ring to a different size or replace the O-ring stretch it over the outer edge of the breast shield. Ensure it goes on with the ridges facing outwards. Press along the groove, checking that it is in place all the way around.

Tubing Features

Breast Pump Controls

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.
   • Correctly assembled system (for double pumping).

OPERATING YOUR BREAST PUMP

Get ready to pump

1. Make sure to use the correct breast shield size. It is an essential component of effective pumping, helping to optimize milk flow.
   • Visit MedelaBreastShields.com (U.S.) for more information.
2. Wash hands thoroughly.
3. Connect your assembled Hands-free Collection Cups to the tubing port on the top of the breast pump.
4. Place the collection cups in your bra.
5. Ensure that the nipple is centered in the tunnel of the breast shield.
6. The Hands-free Collection Cups can be worn under your regular nursing bra. Your bra will hold the collection cup in place. If you find it uncomfortable or painful during use, try switching to a looser, more stretchy nursing bra.
7. The tubing can be connected facing inwards (towards the breasts)or outwards (towards the arms) based on personal preference. Ensure that the tubing is not pinched or bent during use.
8. The Hands-free Collection Cups can be used in a vertical or slightly tilted position for better visibility of the nipple and milk ejection. The scale on the collection cup gives you an approximate indication of the volume during pumping.

Expressing your milk

1. Press the On/Off button ( ) to start pumping.
   • The breast pump begins in the Stimulation Phase.
2. Adjust the vacuum by pressing the Increase vacuum ( + ) and Decrease vacuum ( – ) buttons to find your Maximum Comfort Vacuum™
3. If your milk begins to flow, and the pump has not already changed to the Expression Phase, press the Let-down button ( ). By pressing this button, the pump switches from the Stimulation Phase to the Expression Phase.
   • Your pump will automatically switch to the Expression Phase after one minute of pumping.
4. You may need to adjust the vacuum by pressing the Increase vacuum ( + ) and Decrease vacuum ( – ) buttons to find your Maximum Comfort Vacuum.
5. When your pumping session is over, press the On/Off button ( ) on the breast pump to stop the pump.

After pumping, removing the collection cups from your bra

1. To avoid milk spilling out of the tunnel, when finished, keep the pump running and slightly lean forward to ensure all of the milk inside the breast shield tunnel empties into the collection cup. Once all milk has drained into the collection cup turn off the pump.
2. Remove tubing from the collection cups and breast pump. Do not wrap tubing around the breast pump.
3. Carefully remove the collection cups from your bra.
4. If you don’t press any buttons for 30 minutes, the pump will shut off on its own.

Pouring milk from collection cups and preparing your breast milk for storage:

1. Place the collection cups in an upright position on a surface where they will not be easily knocked over.
2. With the rounded outer shell facing down, pour breast milk through the pouring spout into a bottle or container for storage. Do not use collection cups to store milk. Do not store assembled cups in the refrigerator.
3. Fully disassemble and clean after each use and sanitize once per day.
4. For information on storing your breast milk, visit BreastMilkGuidelines.com (U.S.).
5. Before long-term storage, sanitize and dissembled all parts. Do not store collection cups in assembled state over an extended period of time.

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.

TROUBLESHOOTING

The breast pump generates no vacuum (motor not working) after you pressed 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

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

• Make sure that all the Hands-Free Collection Cups components are clean and dry and that connections are secure.

• Confirm that the O-ring is applied on the breast shield to ensure suction.

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

• 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 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.

DISPOSAL

The pump 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 in accordance with 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 on public health.

Collection cups – Breast shields, outer shells, tubing, O-ring and membranes

The parts are made of plastics that are not harmful to the environment when disposed of as household waste. Recycle or dispose of according to local regulations.

REFERENCE

1. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.1.1 Manufacturer
2. EN 50419, Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE).
3. 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
4. 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)
5. 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
6. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 9 Class II equipment
7. IEC 60417-5957, Graphical symbols for use on equipment, For Indoor use only
8. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 4 Alternating current
9. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 1 Direct current
10. IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 29 Stand-by
11. 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
12. Code of Federal Regulations, Title 47, Part 15b / 15 c
13. 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
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 5.1.7 Serial number / ISO 7000- 2498, Graphical symbols for use on equipment, Serial number
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 5.3.1, Fragile, handle with care / ISO 7000-0621, Graphical symbols for use on equipment, Fragile, handle with care
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 5.3.2 Keep away from sunlight / ISO 7000-0624, Graphical symbols for use on equipment, Keep away from sunlight
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 5.3.4, Keep away from rain / ISO 7000-0626, Graphical symbols for use on equipment, Keep away from rain
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 5.3.7 Temperature Limit / ISO 7000-0632, Graphical symbols for use on equipment, Temperature Limit
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 5.3.8 Humidity Limit / ISO 7000- 2620, Graphical symbols for use on equipment, Humidity 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, pressure Limit
21. ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied, Part 1: General requirements, Clause 5.4.3 Consult instructions for use/ ISO 7000-1641, Graphical symbols for use on equipment, consult instructions for use.

WARRANTY

This product is warranted by Medela to the original retail purchaser to be free from defects in material and workmanship for the period of one year for 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 expense 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 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 WHICH 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, USA

ATTENTION: RETURNS

MEANING OF SYMBOLS

• This symbol indicates the manufacturer.1
• This symbol indicates do not dispose the device together with unsorted municipal waste (in accordance with local regulations).2
• This symbol indicates compliance with international requirements for protection from electric shock. (Type BF applied parts.)3
• This symbol indicates the protection against entrance of solid foreign objects and against harmful effects due to the entrance of water.4
• This symbol indicates the date of manufacture (four digits for the year and two digits for the month and two digits for the day).5
• This symbol indicates the device is a Class II electrical appliance (double insulated).6
• This symbol indicates that the power adaptor is for indoor use only.7
• BREAST PUMP:  GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-6 (2010) + AMD 1 (2013), IEC 62366 (2007) + AMD 1 (2014) and IEC 60601-1-11 (2015).
• This symbol indicates alternating current.8
• This symbol indicates direct current.9
• Caution Sign
• General Warning Sign

• This symbol indicates the location of the On/Off button (stand-by)10
• The UL LISTED mark indicates that the product is manufactured in compliance with UL safety requirements for USA and Canada.
• NOM Certified
• This symbol indicates manufacturer’s catalog number.11
• Indicates the compliance with the requirements of the Federal Communications Commission.12
• This symbol indicates the manufacturers batch code.13
• This symbol indicates the serial number of the device.14
• Contains fragile goods, handle with care.15
• Keep away from sunlight.16
• Keep dry.17
• Defines the temperature range.18
• Defines the relative humidity range.19
• Defines the atmospheric pressure range.20
• Consult instructions for use.21

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.

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, pursuant to 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 in accordance with 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 receiver.
• Connect the equipment into 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 assure 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.

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 assure 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.

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 interrup- tions 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 assure that it is sufficiently low.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity (cont.)

This breast pump is intended for use in the electromagnetic environment specified below. The customer or the user of the breast pump should assure 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 metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a 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.

• a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast 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.
• b Over the frequency range 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):

Band (MHz)| Service|

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.

---|---|---
380 – 390| TETRA 400
430 – 470| GMRS 460, FRS 460
704 – 787| LTE Band 13, 17
800 – 960| GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5
1700 – 1990| GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS
2400 – 2570| Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7
5100 – 5800| WLAN 802.11 a/n

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.

• Vacuum Range
  • -50 to -295 mmHg1, 2
  • 54 to 120 cpm
• Mode of operation: Continuous
  • Pump Unit Size
  • 140 x 77 x 111 mm
  • Pump Unit Weight
  • 1.18 lbs (535g)

Power adapter

Power In| Power Out
100-240V~ 50/60 Hz 0.7A max| 9.0 VDC 2A

Battery Pack

Power Out
9.6 – 12 VDC 2A

Materials touching skin or coming in contact with milk

• Breast shield: Polypropylene

• Outer shell: Polypropylene, Thermoplastic Elastomer

• Membrane: Silicone

• O-ring: Silicone

• Tubing: Silicone, Polycarbonate

• Operation Temperature

  • (5˚C to 40˚C)
  • (41˚F to 104˚F)

• Transport / Storage Temperature

  • (-25˚C to 70˚C)
  • (-13˚F to 158˚F)

• Operation / Storage Humidity

  • %

• Transport / Storage Humidity

  • %

• Ambient Pressure

  • kPa

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

1. Maximum Vacuum in Expression (when single or double pumping).
2. Under the 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.

Content appearance may vary from pictures.
Medela wordmark and logo, Pump In Style, and 2-Phase Expression are registered in the U.S. Patent and Trademark Office.
MaxFlow, Maximum Comfort Vacuum, and Science of Care are trademarks of Medela.

15400089 A 0323 © 2023 Medela 101045886

References

• Breastfeeding & Pumping
• Breastfeeding & Pumping

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