Ameda Platinum Instructions Aug 2013

CONTENTS

4

Cleaning Ameda Platinum Breast Pump For At-Home/End-Users For Hospitals/Rental Stations

Ameda Platinum Breast Pump Trolley

5

Troubleshooting

7

Set Up and Assembly Ameda ® HygieniKit ® Milk Collection System Before Every Use Single and Dual Pumping

6 6 6 6

Maintenance

7

Controls and Displays Using “Up/Down” Buttons Operating the Pump Setting Suction Setting Speed Using Timer Turning Pump Function Off Removing Ameda HygieniKit Milk Collection System from Breast(s)

6 6 6 6 6 7 7

Important Safeguards

3

Intended Use

3

Ameda Platinum Breast Pump Diagram

7 7 7 7

Technical Information

7

Icon Glossary

10

Product Disposal

10

Warranty Information

10

7

IMPORTANT SAFEGUARDS

Intended Use

When using electrical products, especially if children are present, the following basic safety precautions should always be maintained.

The Ameda Platinum Breast Pump is intended to facilitate the expression and collection of breast milk from a lactating woman for the purpose of feeding the collected milk to a child.

READ ALL INSTRUCTIONS BEFORE USING Danger: To reduce the risk of electrocution: • Always unplug electrical devices immediately after use. • Do not use while bathing, showering or swimming. • Do not place or store where product can fall or be pulled into bathtub, sink or pool. • Do not place or drop product into water or other liquid. • Do not reach for electrical product that has fallen into water. Unplug from wall outlet immediately. Warning: To reduce the risk of burns, electrocution, fire, or injury to persons: • Never leave product unattended when plugged into electrical outlet. • Close supervision is necessary when product is used near children or invalids. • Use product only for intended use as described in this manual. • Do not use attachments or other milk collection kits other than those recommended by manufacturer. • Never operate if product has damaged cord or plug, is not working properly, or has been dropped, damaged, or becomes wet. • Keep cord and all attachments away from heated surfaces. • Never use while sleeping or drowsy. • Do not use outdoors with cord. • Do not operate where aerosol spray products are being used or oxygen is being administered. Caution: To reduce the risk of fire or chemical burn: • Do not disassemble or heat above 100°C (212°F).

SAVE THESE INSTRUCTIONS

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3

Bottom View Vue du bas Vista inferior

EN Attaching the Ameda Platinum Breast

13 14 15

Pump to Trolley (if applicable) Trolley Trolley is available as an accessory item. • Attach pump to trolley prior to plugging cord into wall outlet. • Align front of the Ameda Platinum Breast Pump with wording, “Front of Ameda Platinum Pump and EliteTM Pump” found on top of trolley mounting plate. • Lower pump onto plate, inserting pump’s four feet into holes, one in each corner of trolley mounting plate. • Locate mounting hole with wording, “Ameda Platinum and Elite Pump Mounting” found on underside of trolley mounting plate. • Use mounting screw for the Ameda Platinum Breast Pump supplied with trolley to secure pump to trolley base.

Trolley Plate Top View (optional accessory) Vue supérieure de la plaque de chariot (accessoire en option) Vista superior de la placa de la base (accesorio opcional)

16 18 17

FRONT OF AMEDA PLATINUM PUMP AVANT DU TIRE-LAIT AMEDA PLATINUM PARTE DELANTERA DE LA BOMBA AMEDA PLATINUM

13. Pump Feet Pied du tire-lait Patas de la bomba 14. Trolley Mounting Hole Trou de montage du chariot Orificio de montaje de la base 15. Service Port Door Porte de port de service Puerta del puerto de servicio 16. Pump Rear Foot Location Emplacement du pied arrière du tire-lait Ubicación de las patas traseras de la bomba 17. Pump Front Foot Location Emplacement du pied avant du tire-lait Ubicación de las patas delanteras de la bomba 18. Pump Mounting Hole Trou de montage du tire-lait Orificio de montaje de la bomba

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5

Set Up and Assembly

Controls and Displays

Ameda HygieniKit Milk Collection System Before Every Use Always wash hands well with soap and water before handling the Ameda Platinum Breast Pump and Ameda HygieniKit Milk Collection System.

Before starting pump, please note how the controls work. • Press and release controls to increase/decrease settings by increments of 1. • Press and hold controls to increase/decrease settings by increments of 10. Operating the Pump • When pump is plugged in, a suction speed light will appear next to the Power button. • Press the Power button. The displays light up. Pump is now ON. • Pump starts at lowest suction setting (1% or approximately 30mmHg / 4.0kPa) and maximum speed (80 cpm).

IMPORTANT NOTE: ONLY USE THE AMEDA HYGIENIKIT MILK COLLECTION SYSTEM ON AMEDA ELECTRIC BREAST PUMPS. Prior to starting pump, assemble and connect the Ameda HygieniKit Milk Collection System, per included instructions. If the Ameda HygieniKit Milk Collection System is sterile, use as is. If not sterile, see the Ameda HygieniKit Milk Collection System cleaning instructions. Ameda Platinum Breast Pump Pump • Attach Ameda supplied grounded power cord to AC power inlet on rear of pump. • Connect grounded plug to wall outlet.

2 1

Adapter Cap Silicone Diaphragm Breast Flange eed

3

Valve

4 Milk Bottle 5 Tubing Tubing Adapter The Ameda HygieniKit Milk Collection System can be used to single or dual pump.

To single pump: Remove one tube and close tubing adapter.

To dual pump: Both tubes should be attached to tubing adapter. • Insert tubing adapter into tubing adapter port.

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suction

timer

Setting Suction • Pump starts at lowest suction setting (1% or approximately 30mmHg/4.0kPa). • Center nipple(s) in breast flange(s) and fill breast flange(s) with the breast(s) to create an air seal. • Press to increase suction until reaching maximum comfort level. • If discomfort is felt in nipple(s) or breast(s), decrease suction. If discomfort is felt at all suction settings, turn pump off, insert a finger between breast(s) and breast flange(s) to break suction, remove breast flange(s) from breast(s). Discontinue pumping and contact a healthcare provider.

Setting Speed • Pump starts at fastest speed (80 cpm). • When milk flows (let-down), press to a slower suction speed speed to help drain the breast faster. • When milk flow slows, press to 60-80 cpm to help start another let-down. • Repeat as milk flow changes to pump more milk. NOTE: If “Check Kit” appears in suction window, see Troubleshooting section, on page 7.

Using Timer • Timer starts when pump is on. Timer displays pumping duration in minutes : seconds. • Timer can be reset by pressing Timer Reset button. • Timer and pump automatically turn OFF after 60 minutes.

timer

suction

speed

suctio

Turning Pump OFF • When finished pumping, press and hold Power button to turn pump and timer functions OFF.

“Check Kit” error message appears • Ensure tubing adapter is properly fitted into tubing adapter port on pump. • Ensure one side of tubing adapter is closed when single pumping. • Check that adapter cap is firmly snapped onto top of breast flange. • Ensure silicone diaphragm is in place inside top of breast flange. • Check tubing and silicone diaphragm to ensure that parts are free of defects. • Check tubing is firmly attached to adapter cap. “Service Required” error message appears • Call your local distributor. For listing of distributors worldwide, visit www.ameda.com. The Ameda Platinum Breast Pump should be serviced only by Ameda, Inc. or authorized Service Centers approved by Ameda, Inc.

Maintenance Removing Ameda HygieniKit Milk Collection System from Breast(s) • After pump is OFF, if necessary, insert a finger between breast(s) and breast flanges(s) to break suction. • Remove breast flanges(s) from breast(s).

Cleaning the Ameda Platinum Breast Pump For At-Home/End-Users After each pumping, wipe the Ameda Platinum Breast Pump with clean, damp cloth. For Hospitals/Rental Stations Clean between users. Wearing disposable gloves, wipe the Ameda Platinum Breast Pump with damp disposable cloth using hospital approved antibacterial cleaner, such as CaviCideTM.

Troubleshooting Pump does not turn ON • Ensure proper power cord connection to pump. • Ensure grounded plug connection to electrical outlet. • Ensure outlet has power. Unable to adjust speed • Ensure pump function is ON. • Ensure “Check Kit” is not shown in suction display window. Unable to adjust suction • Ensure pump function is ON. • Ensure “Check Kit” is not shown in suction display window. Low or no suction • Ensure “Check Kit” is not shown in suction display window. • Check breast flange for adequate seal against breast. • Check that the Ameda HygieniKit Milk Collection System is properly assembled. • Check that adapter cap is firmly snapped onto top of breast flange. • Ensure silicone diaphragm is in place inside top of breast flange. • Ensure tubing adapter is properly fitted into tubing adapter port on pump. • Inspect valve for stretching or tears. If seen, replace valve. • Ensure valve is pushed firmly into place in lower portion of breast flange. • Ensure one side of tubing adapter is closed when single pumping.

It is recommended the Ameda Platinum Breast Pump be inspected at least once every year to include the following: • Visually check pump housing for cracks, breakage, or damage and ensure Pump Feet are present. • Visually check for power cord damage. • Check for proper operation of controls and buttons. • Check there are no missing screws. • Check cover is present on Service Port Door. • Check Tubing Adapter Port is free from obstruction. Quick Functional Check The following checks/tests should be performed prior to use by a new user: • Visual checks for power cord damage. • Check for abnormal noise. • Check for proper operation of controls and buttons. Service Port • Do not open Service Port Door on bottom of the Pump. • Do not connect any equipment to the service port when operating the pump. • Service port is to be accessed only by authorized Service Centers approved by Ameda, Inc. Replacing Detachable Power Cord: • Power cord is detachable from power inlet. • If power cord condition is in doubt, only replace with Ameda supplied 3-conductor cord equipped with protective ground conductor.

Technical Information Protection Class 1, Type B Power Supply: Operating Input Voltage 100 VAC to 240 VAC Operating Frequency 50/60Hz Input Power 80VA Fuse Rating Quick Acting (F), 2.5A, 250V, 5 x 20mm Power Cord: Use only Ameda supplied power cord For North America, use Ameda 24502059 Minimum Voltage Rating: 125V Minimum Current Rating: 10A Plug Type: IEC 60320 C13 (Hospital Grade) Maximum Length: 10 feet (3.05m) Cord Type: 3x18AWG, rated VW-1, 105C Jacket Type: SJT or SJTW Certification: UL Listed (ELBZ) Operation: Continuous ISO 10079-1, Intermittent Suction, Medium Vacuum Suction: Shown in percentage of full scale suction 1%-100%; (approximately 30mmHg to 250 mmHg/4.0kPa to 33.3kPa) Speed: 30 to 80 cycles per minute (cpm)

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Operational Conditions: Pump Temperature +53°F (+12°C) to +93°F (+34°C) Relative Humidity 20% to 70% Atmospheric Pressure 0.82 atm (83.1kPa) to 1.05atm (106.4 kPa) Transport and Storage Conditions: Pump Temperature -10°F (-23°C) to +130°F (+54°C) Relative Humidity 20% to 90% Atmospheric Pressure 0.82 atm (83.1 kPa) to 1.05atm (106.4 kPa)

Weight: Approximately 9.75 lbs. (approximately 4.42 kg) Dimensions: Length 9.75 in. (24.7 cm)/Width 10.5 in. (26.7 cm)/Height 8.0 in. (20.3 cm) Standards: E325189 MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC60601-1: 1988 + A1:1991 + A2:1995, IEC60601-1-2, CAN/CSA C22.2 No. 601.1-M90

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC provided in these Instructions for use. Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. Warning: The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cabled sold by the MANUFACTURER of the

Ameda Platinum Breast Pump as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Ameda Platinum Breast Pump. Warning: The Ameda Platinum Breast Pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Ameda Platinum Breast Pump should be observed to verify normal operation in the configuration in which it will be used.

Guidance and manufacturer’s declaration – electromagnetic emissions The Ameda Platinum Breast Pump is intended for use in The customer or the user of the Ameda Platinum Breast the electromagnetic environment specified below. Pump should assure that it is used in such an environment. Emissions test RF emissions CISPR 11

Compliance Group 1

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3

Class B Class A Complies

Electromagnetic environment – guidance The Ameda Platinum 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. The Ameda Platinum 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.

Guidance and manufacturer’s declaration – electromagnetic immunity The Ameda Platinum Breast Pump is intended for use in The customer or the user of the Ameda Platinum Breast the electromagnetic environment specified below. Pump should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2

IEC 60601 test level ± 6 kV contact ± 8 kV air

Compliance level ± 6 kV contact ± 8 kV air

Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

± 2 kV for power supply lines/± 1 kV for input/output lines ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth <5% U t (>95% dip in U t) for 0,5 cycle 40% U t (60% dip in U t) for 5 cycles 70% U t (30% dip in U t) for 25 cycles <5% U t (>95% dip in U t) for 5 s 3 A/m

± 2 kV for power supply lines/± 1 kV for input/output lines ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth <5% U t (>95% dip in U t) for 0,5 cycle 40% U t (60% dip in U t) for 5 cycles 70% U t (30% dip in U t) for 25 cycles <5% U t (>95% dip in U t) for 5 s 3 A/m

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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

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Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Ameda Platinum Breast Pump requires continued operation during power mains interruptions, it is recommended that the Ameda Platinum Breast Pump be powered from an uninterruptible power supply. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration – electromagnetic immunity The Ameda Platinum Breast Pump is intended for use in the electromagnetic environment specified below. The

customer or the user of the Ameda Platinum Breast Pump should assure that it is used in such an environment.

Immunity test

Compliance level

Electromagnetic environment – guidance

3 Vrms

Portable and mobile RF communications equipment should be used no closer to any part of the Ameda Platinum Breast Pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2√P

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

IEC 60601 test level

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz

3 V/m

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

d = 1,2√P 80 MHz to 800 MHz d = 2,3√P 800 MHz to 2,5 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,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:

site survey should be considered. If the measured field strength in the location in which the Ameda Platinum Breast Pump is used exceeds the applicable RF compliance level above, the Ameda Platinum 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 Ameda Platinum Breast Pump. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Ameda Platinum Breast Pump The Ameda Platinum Breast Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Ameda Platinum Breast Pump can help prevent electromagnetic interference by maintaining a minimum Rated maximum output power of transmitter W 0,01 0,1 1 10 100

distance between portable and mobile RF communications equipment (transmitters) and the Ameda Platinum Breast Pump as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1,2√P d = 1,2√P d = 2,3√P 0,12 0,12 0,23 0,38 0,38 0,73 1,2 1,2 2,3 3,8 3,8 7,3 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.

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Icon Glossary

Product Disposal This product contains electrical and electronic equipment.

Type B Applied Part Connected to Wall Outlet % of Full Scale Suction 1% -100%; (approximately 30mmHg to 250mmHg/4.0 kPa to 33.3kPa) Cycles Per Minute (30-80 cpm) Timer Display

1. The internal components of this product may contain hazardous materials. Dispose of this product according to local or regionalminimum waste administration systems and regulations. size 2. Do not dispose of as unsorted municipal waste. 3. For further information regarding the environmental performance of this product please visit our website www.ameda.com.

Consult Instructions For Use

Limited Warranty Fuse Liquid ingress classification E325189 MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC60601-1: 1988 + A1:1991 + A2:1995, IEC60601-1-2, CAN/CSA C22.2 No. 601.1-M90

Fragile Protect from sunlight Keep Dry 130ºF 54ºC

Transport/Storage

-10ºF -23ºC 20

90

%

93ºF 34ºC

Operation

53ºF 12ºC 20

70

%

0086 EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31.70.345.8570 Fax: +31.70.346.7299 Ameda, Inc. 485 Half Day Road Buffalo Grove, IL 60089 USA

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The Ameda Platinum Electric Breast Pump (“Product”) is warranted to the original user--whether institutional or individual (“First User”)--only. From the date of First User’s purchase of this Product, Ameda, Inc. (“Ameda”) warrants the Product to the First User against defects in material or workmanship for three years on the pump mechanism. Ameda’s sole obligation under this limited warranty shall be to repair or replace, at Ameda’s option, any Product that is determined to be defective by Ameda and determined to be covered by this express limited warranty. Repair or replacement under this limited warranty is the sole and exclusive remedy of the First User. Proof of purchase in the form of a receipted invoice or bill of sale evidencing that the Product is within the warranty period must be presented to obtain warranty service. This limited warranty is extended by Ameda ONLY to the First User and is not assignable or transferable. For warranty service contact Ameda at 1.866.99 AMEDA(26332). EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ON THE PRODUCT IS HEREBY DISCLAIMED. AMEDA SHALL NOT BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OF ANY KIND FOR BREACH OF THE EXPRESS LIMITED WARRANTY ON THE PRODUCT OR ANY WARRANTY IMPLIED BY OPERATION OF LAW, OTHER THAN THE EXPRESS LIMITED WARRANTY SET FORTH ABOVE, THERE ARE NO OTHER WARRANTIES THAT ACCOMPANY THIS PRODUCT AND ANY ORAL, WRITTEN OR ANY OTHER EXPRESS REPRESENTATION OF ANY KIND IS HEREBY DISCLAIMED. Non-Applicability of Warranty The above warranty shall not apply to consumable materials and attachment to the Product. These include: (i) the power cord; and (ii) the Ameda HygieniKit Milk Collection System (sold separately). In addition to any other limitations on the warranty discussed above, the warranty shall expire and be of no force or effect upon the occurrence of any of the following: (i) the cause of damage to the Product is due to improper handling or use (ii) the Product is not properly maintained by the First User, as determined by Ameda (iii) non-Ameda approved accessories or spare parts are used with the Product, as determined by Ameda (iv) the Product is repaired by a non-approved Ameda service provider. If any of the above occurs, Ameda shall not be responsible for damage to the Product, parts thereof or injuries arising therefrom, either directly or indirectly. The warranty set forth above replaces all prior warranties with respect to the purchased Product, whether in writing or otherwise. Outside the United States: Call your local distributor or location where you purchased the Product. For a listing of distributors in your country, please visit www.ameda.com.

0086 EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31.70.345.8570 Fax: +31.70.346.7299 Ameda, Inc. 485 Half Day Road Buffalo Grove, IL 60089 USA

Distributed in USA by: Ameda, Inc. 485 Half Day Road Buffalo Grove, IL 60089 1.866.99.AMEDA (26332) Distributed in Canada by: Distribué au Canada par: Mothers Choice Products Ltd. 2133-11871 Horseshoe Way Richmond, BC V7A 5H5 1.800.604.6225

Distributed in Australia by: Advantage Health Care 34 Percy Street Mordialloc VIC 3195 61 (3) 9580 9288 Distribution in other countries: For product information or feedback, visit www.ameda.com

Ameda, Ameda Platinum, Elite, SMB, Lact-e, HygieniKit and associated logos are trademarks of Ameda, Inc. Any other trademarks, brand or images appearing herein are property of their respective owners and are used herein with expressed or implied permission. ©2013 Ameda, Inc. 25708696-0813