BiliBed Instructions for Use Rev D Sept 2010

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Instructions for use

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Instrukcja Obsługi

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Návod k použití

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Kezelési útmutató

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Dear Client We would like to congratulate you on purchasing the Medela BiliBed®. We are confident that you have made the right choice and that you will be fully satisfied. The following pages show you how to use and maintain the BiliBed. If these instructions are followed carefully, your BiliBed will have a long and reliable operating life. ISO EN FDA GMP

International Organisation for Standardization European Norm Food and Drug Administration Good Manufacturing Practices

Medela AG reserves the right to change technical specifications for the improvement of the product at any time without prior notice.

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We would like to thank you for the confidence you have placed into our company by purchasing this product. We develop and produce our products with a certified quality-management system according to EN ISO 13485:2003, as well as according to the guidelines of the American FDA for GMP.

Safety Note Working with the BiliBed requires precise knowledge of its areas of application as well as adherence to these instructions. In cases where there is any uncertainty, trained staff familiar with the equipment must be consulted. Caution The BiliBed may not be used in environments • where there is a risk of explosion • with a warming bed The Phototherapy Lamp may not be used in environments • where there is a risk of explosion • enriched with oxygen • in an incubator Attention The use of these lamps for anything but their intended purpose can be hazardous. Portable and mobile RF communication devices may influence the device. Separation from the mains is only assured through the disconnection of the plug and socket connection. A small percentage of the population is sensitive to blue light. Do not use the BiliBed without the Bilicombi. In each of the following cases, the device must not be used and it must be repaired by Customer Services: • If the power cable or the plug are damaged • If the device is not functioning perfectly • If the device is damaged • If the device shows clear safety defects

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Description Medela‘s BiliBed is a modern, top-quality phototherapy system. It has been developed according to the latest medical findings for the treatment of neonatal hyperbilirubinaemia. The BiliBed can be fitted to most hospital cots currently available. It is therefore particularly suitable for rooming-in. The phototherapy bed works with very low energy consumption. Follow-up costs are also extremely low, since only a single blue light fluorescent tube has to be replaced.

III Applications Indications Medela‘s BiliBed is designed for the efficient and safe treatment of excessive serum-bilirubin concentrations in newborn babies. It is indicated for use for all babies which do not require treatment in an incubator and have no further complications. Contra-indications A rapidly rising bilirubin level may require a more intensive therapy. Warning The use of these lamps for anything but their intended purpose can be hazardous The BiliBed may not be used: • inside an incubator or warming bed. • in environments where there is a risk of explosion or enriched with oxygen. • portable and mobile RF communication devices may influence the device.

IV Equipment The light unit contains a highly-polished aluminum reflector and an energy-saving blue light fluorescent tube. A silent, rotary fan provides the necessary amount of air exchange around the fluorescent tube. The special tube emits light mainly in the 425–475 range (blue light). Two hour meters are integrated in the BiliBed light unit. The “total h“-meter is not re-settable and helps determine the time for changing the light tube. The “h“-meter is re-settable and indicates the elapsed therapy time. The light unit, which contains the irradiation and the electronics, is covered with a transparent, waterproof, plexiglass plate. The surface is comprised of an aluminum frame covered with a transparent, skin-friendly plastic cover made of polyurethane (PUR). For optimum positioning of the baby, the BiliBed has a therapy blanket (Bilicombi). Light is directed at the baby through the light permeable fabric on the bottom of the therapy blanket. This permits optimum treatment and protects surroundings from disturbing blue light. Never alter or exchange the light permeable fabric of the Bilicombi! The therapeutical effect cannot be guaranteed when this is done.

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Assembly 5.1 Light unit 1

The BiliBed is equipped with a power cord attached to a 12V DC power adapter. It is connected to the light unit. In order to remove, pull on the plug housing (not the cord itself or the anti-bend protection). Next to the power adapater, the START/STOP switch can be plugged in to the socket in order to switch fluorescent tube on and off. 6

Note The electronics of the BiliBed are protected against damage through voltage spikes in the mains electricity supply. If there is an excessive voltage surge in the power network, your BiliBed will switch off automatically. It can be turned on again for further use by pressing the START/STOP switch.

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5.2 Baby support 7

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Preparation of the frame: • Press the two red buttons underneath the frame at the same time and raise the side of the frame.

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Fitting the plastic cover to the aluminum frame: • Unpack and unroll the clear plastic cover. There is a groove on each of the long sides of the aluminum frame. Insert the long sides of the plastic into these grooves. Insert enough plastic to evenly cover the aluminum frame. Close the frame by pressing the open side down with both hands until it clicks shut. The plastic is now correctly tightened. The baby support can carry the weight of approx. 10 kg. For heavier babies, or when a even new foil is over-stretched, we recommend to use the Medela Phototherapy Lamp.

01) Head of BiliBed 02) Hour meters 03) Start/Stop switch 04) 12V DC power adapter 05) Socket 06) Foot end of BiliBed 07) Plastic cover 08) Button 09) Groove 10) Aluminum frame

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VI Installation of the BiliBed in the hospital cot 6.1 Installation of the light unit • Remove the mattress from the cot. It will not be needed. Warning The BiliBed is not designed for use in an incubator. Do not use the BiliBed without a baby crib or bassinet.

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• Place the BiliBed light unit in the baby‘s crib or bassinet. To make sure that sur rounding panels protect the baby, never use the BiliBed without a crib or bassinet. Important Sufficient air must circulate around the BiliBed. This is insured if the base of the crib or the bassinet is provided with ventilation openings. If this is not the case, the BiliBed should be surrounded by enough free space to maintain temperature balance. The total ventilation openings must have a minimum area of 20 cm2, or about the space necessary to fit the width of a regular pencil or pen. The amount of heat given off by the BiliBed is not significant nor is it problematic when it is used in the hospital or home according to our instructions. • Insert the power cord and the cable with the START/STOP switch through the openings in the base of the cot. If the cot has no openings in the base, hang the cable over the side of the cot. For safety reasons this must be at the foot end of the cot.

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6.2 Installation of the baby support • Place the baby support on top of the light unit so the two twin strips of Velcro® (on the plastic) are next to the drawing of the baby‘s head on the light unit.

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Baby support 01) Twin Velcro strips Light unit 02) Head of BiliBed 03) Foot of BiliBed 04) Start/Stop switch Bilicombi therapy blanket 05) Flaps 06) Wide strips of Velcro Baby support 07) Head of BiliBed 08) Velcro strips 09) Plastic cover 10) Foot of BiliBed 6

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Important The baby support must be positioned correctly to ensure that the baby is in the correct position for treatment.

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6.3 Attachment of the Bilicombi therapy blanket • Fasten the Bilicombi therapy blanket to the baby support. Make sure the position is correct. This can be determined by the drawing on the light unit, i.e. the foot end of the Bilicombi should correspond to the position of the baby‘s feet. Align the wide, white strips of Velcro under the Bilicombi with the four Velcro tabs on the baby support. Important The Bilicombi therapy blanket must be positioned correctly to ensure successful treatment as well as a safe and efficient positioning of the baby. The baby‘s body must lie on the therapy lamp and its head must be positioned according to the drawing on the light unit. Warning Sufficient air must circulate around the BiliBed (total ventilation openings must have a minimum area of about the space necessary to fit the width of a regular pencil or pen). If the space around the BiliBed does not meet the requirements for proper air circulation, the flaps of the Bilicombi can be folded under the plastic surface of the Baby support.

VII Irradiation levels According to the study from M. Jeffrey Maisels (Pediatrics Vol. 98, No. 2, August 1996: Why use Homeopathic Doses of Phototherapy) the efficacy of phototherapy depends on three factors: • Spectrum of light delivered by the phototherapy unit. Because of the optical properties of bilirubin and skin, the most effective wavelengths are in the blue-green spectrum. • Power output of the light. This also depends on the distance of the light from the infant. The lower the distance, the higher the efficacy. • Surface area of the infant exposed to phototherapy. The efficacy is higher when more skin is subjected to phototherapy.

Wavelength with baby support & Bilicombi

spectral irradiation [w/m2/5nm]

with baby support

Wavelength [nm]

Irradiation, effective surface area Ebi max (400–550nm) Effective surface area: Room temperature:

= max. irradiation in a central area within this area Ebi ≥ 0.4 Ebimax (25± 2) °C

Foot end

Head end

Maximum values Ebi max (400–550nm) = 49.1 W/m2 Average values Ebi max (400–550nm) = 33.9 W/m2 Effective surface area 21 × 27 cm

Corresponds to the effective surface area with measured spots Corresponds to the BiliCombi Corresponds to the cut-out sector of the Bilicombi

Effective surface area Light is focused on the baby through the cut-out sector on the backside of the Bilicombi. The size of this sector corresponds to the effective surface area. In order to achieve the best therapeutical effect, the baby should wear small diapers. If necessary, roll down the top of the diaper below baby‘s naval so that the maximum amount of bare skin will be exposed to the therapeutic light.

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VIII Therapy 8.1 Preparing the baby In order to achieve the best therapeutical effect, the baby should wear small diapers. If necessary, roll down the top of the diaper below baby‘s naval so that the maximum amount of bare skin will be exposed to the therapeutic light.

8.2 Dressing the baby in the Bilicombi therapy blanket Note The BiliBed is designed for use with the Medela Bilicombi therapy blanket only. The Bilicombi keeps the baby warm and correctly positioned for effective phototherapy. The therapeutical effect of the BiliBed can only be guaranteed if the Medela Bilicombi is used. The Bilicombi protects its surroundings from disturbing blue light. When the Bilicombi is positioned incorrectly, leaking blue light may cause nausea or headaches of blue-light sensitive nursing staff. • Check the Bilicombi before each use. The light-permeable fabric must be without damages and soft to the touch. The Velcro fasteners should guarantee a tight attachment to the baby support. If this is not the case, replace with a new Bilicombi. • Attach the Bilicombi blanket to the baby support. • Unzip the Washable Bilicombi blanket or unfasten the Velcro on the jacket of the Disposable Bilicombi. • Place the baby in the blanket either on its back or its front. The arms of the baby must be put in the sleeves of the blanket, to avoid a possible moving of the child. Warning We recommend to place the baby on its back. If the baby is restless and active this will prevent any abrasions on its knees. As the BiliBed has a high irradiance, the therapeutical effect would not be diminished by treating the baby in supine position only. If the baby is placed in prone position, it is necessary to make sure that the baby’s knees are not red. If necessary, treat the baby on its back. • Put the arms of the baby into the sleeves of the Bilicombi blanket. • Zip/Fasten Velcro® on the Bilicombi blanket. Close the Velcro fastener under the baby‘s chin. Caution Frequently check on the baby during phototherapy treatment. If the baby seems too warm, make sure that the air circulation is guaranteed, i.e.: • the ventilation slots in the device are not covered by pillows or covers. • there is enough room around the BiliBed (especially at the foot and head end) for air to circulate (at least 1 cm). If the ambient temperature of the room is very high, fold the flaps of the Bilicombi under the plastic surface of the Baby support to increase air circulation. The Bilicombi blanket helps keep the baby warm. If additional warmth is necessary, a blanket can be placed over the Bilicombi. When using a blanket, you must take care to guarantee the air circulation around the BiliBed. Monitor the baby regularly. Make sure the baby is lying on the baby support correctly. Check the foil of the baby support before each use. If this is no longer stretched and sags, a new foil should be used. The foil can carry a weight of up to 10 kg. For heavier babies we recommend using the Medela Phototherapy Lamp.

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8.3. Beginning therapy • Connect the cable to the power supply, ensuring in advance that the voltage matches the details given on the specification plate. • The light unit can be switched on or off with the START/STOP switch. Even if the fluorescent tubes are switched off at the switch, the BiliBed remains operational, i.e. connected to the power supply. The equipment is only completely switched off when the plug is disconnected from the power supply. Note The START/STOP switch can be omitted entirely. The light unit can be started and stopped by plugging in or unplugging the power cord to the unit. Caution The therapy blanket must be positioned correctly to ensure successful treatment. The baby must lie above the therapy lamp. The position of its head and feet must be according to the drawing on the light unit. Caution Supervise the infant during therapy. Regular checks are necessary: • Check the bilirubin levels. Photoisomeres of bilirubin may cause toxic effects. • Phototherapy influences the baby‘s temperature. A regular check is necessary. • Phototherapy influences the infant‘s water balance. In order to prevent dehydration, it may be necessary to feed the baby more often. Attention Auxiliary devices which are used in the same area as the BiliBed must comply with the general requirements for safety according to IEC 60601-1.

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IX Hour meters The BiliBed is equipped with two hour meters. When the fluorescent tube lights up both will start counting. This is indicated by the blinking hourglasses. The hour meter “total h“ measures the total time the BiliBed has been in use. It cannot be reset. By reviewing and separately recording this display, you have accurate means of determining when the fluorescent tube should be changed. To ensure high therapeutical effectiveness, we recommend to change the fluorescent tube every 1500 hours.

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The hour meter “h“ shows the therapy time. This meter can be reset. For resetting to “0“: press the START/STOP switch and hold down for 15 seconds. The BiliBed must be plugged in. Because this display can be reset, it should not be used to determine when the bulb should be replaced.

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Note Both displays only light up when the BiliBed is plugged in.

Hour meters

Maintenance Warning Disconnect power supply before performing maintenance jobs! An annual routine control of the displays on the hour meters and the function of the BiliBed is recommended.

10.1 Changing the fluorescent tube In a 1500 hour-interval, the light tube needs changing. By using the “total h“ hour meter this time interval can be monitored accurately. The BiliBed is equipped with a “Light Tube Change Log“-card on the inside of the light unit. On this log you will find a table as follows:

Light Tube Change Log Lampenwechsel-Kontrolltabelle Fiche de suivie – Remplacement du tube Tarjeta de control de cambio de lampara Recommended hours Empfohlene Stunden Nb. heures recom. Duracion recomendada

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Actual hours Aktuelle Stunden Nb. heures réel Total horas consumidas

Date of change Datum Date Fecha

Signature Unterschrift Signature Firma

In this table you will see the recommended hours for a tube change on the left. When a tube change is performed, the actual hours on the hour meter (“total h“) should be filled in the appropriate column. Also included are two columns for inserting date and signature. • Unplug the light unit from the power supply. • Remove the baby support from the light unit. • Release the 10 screws with a screwdriver and remove the plexiglass cover. • Lift the metal clamp and carefully remove the light tube from its socket and from its clip. • Put the tube aside immediately in order to avoid confusion. • Insert the new tube into the clip and push into the socket until it snaps in. • Readjust metal clamp for a secure hold. Warning Replacement tubes must be of the type used by Medela. Otherwise the safety and success of the therapy cannot be guaranteed! We recommend changing the light tube every 1500 hours in order to guarantee therapeutic effectiveness. • Check that the reflector is clean and shiny, correct if not. • Re-mount the plexiglass cover with the 10 screws.

10.2 Cleaning and disinfecting • Unplug the unit from the power supply. Light unit and baby support The outside surfaces can be cleaned with a damp cloth. For disinfecting, alcohol may also be used. Cleaning or disinfecting agents should not be used in concentrated form! If the baby support shows signs of wear, sags or is damaged, replace with a new one. Important Do not use cleaning solutions such as appliance disinfectants which use formaldehyde. Do not autoclave the baby support or disinfect by using heat. Bilicombi therapy blanket If you are using a Disposable Bilicombi, discard the Bilicombi after 24 hours or if it becomes soiled. The Disposable Bilicombi is designed for single patient use. If you are using a terry cloth, Washable Bilicombi, follow the cleaning instructions below: • Remove Bilicombi from BiliBed. • Zipper Bilicombi and attach under-chin Velcro fastener. • Wash for Standard Machine cycle. Minimum wash cycle of 10 min is recommended. • Machine wash in hot water. We recommend a temperature of 140 degrees F (60 °C). The maximum temperature is 210 degrees F (95 °C). • Standard cleaning detergent to be used. Refer to washing machine manufacturer for instructions. • Use of Chlorine Bleach can cause color to bleed and/or fade and can reduce life of Bilicombi. • Tumble dry low heat. If any of the Velcro fasteners shows decreased adherence or the light-permeable fabric is damaged/too stiff a new Bilicombi should be used.

10.3 Troubleshooting If the light goes out during therapy: • Check if the fan is working properly. If it does not run at the proper speed or if it is blocked, an electronic safety circuit switches the lamp off in order to protect the system from overheating. Replace fan if necessary. • If necessary, change tube.

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XI Disposal The BiliBed is of modular design. It can thus be disassembled into its individual components. The BiliBed is mainly made of technical plastics which can be disposed of in accordance with local regulations. The fan, lamp and electric parts should be disposed of separately.

XII Technical Data 12.1 Light unit Power supply

Power consumption Irradiation (according to IEC 60601-2-50)

Tube life Air pressure Relative operating humidity Relative storage and transport humidity Operating temperature Storage and transport temperature Noise level Standards

Power adapter (TR30RAM120): Input: 100 – 240V AC, ~47-63Hz , 0.8–0.4A Output: 12V DC, 2.5A 30 W with compact fluorecent lamp (Osram Dulux L18W/71 or Ralutec long 18W/71) Ebi max = 49 W/m2 approx. 1500 hours 70 – 106 kPa 20 – 80% 20 – 95% +5 to –30 °C –20 to +50 °C <20 dB(A) CE (93/42/EWG) EN 60601-1:1990 (IEC 60601-1:1988 + A1:1991 + A2:1995) EN 60601-2-50:2002

12.2 Baby support • Outer dimensions • Cover material

630 × 326 × 42 mm Skin-friendly polyurethane (PUR)

12.3 Complete device • • • •

Total dimensions Working conditions Storage conditions Weight

630 × 326 × 134 mm +5 °C to + 30 °C –20 °C to + 50 °C 4.0 kg

12.4 Bilicombi • Material • Light permeable fabric material

75% cotton, 25% polyester 100% cotton

Electromagnetic Compatibility (EMC) The Medela BiliBed is a medical device which complies with special safety measurements concerning EMC and must be installed and made ready for use according to the EMC information at the end of these instructions for use. Portable and mobile RF communication devices may influence the device.

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XIII What the symbols mean BiliBed Ensure that the patient is positioned correctly. The baby can be laid on his back or on his stomach, if the doctor recommends, with its head towards the top, according to the drawing on the light unit. We recommend to place the baby on its back. If the baby is restless and active this will prevent any abrasions on its knees.

The BiliBed should not be used in an incubator

On/Off switch for lamp

Refer to instructions

Model B unit

IPX4

Protection against splashing water

Power adapter

Direct current

Protection class II

Must not be disposed of together with household refuse

For indoor use only

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XIV Ordering references Medela BiliBed, comprised of an light unit, Start/Stop switch, baby support with a plastic cover. 038.4001 099.0115 099.0116 800.0229 099.0144 099.0143

BiliBed Fluorescent tube, 10 pcs Fluorescent tube, single Therapy blanket Bilicombi, washable single Plastic cover, 5 pcs Plastic cover, single

Detailed service documentations including circuit diagrams, spare parts list, etc. are available on request from Medela or from your local Medela agent. Please give the relevant serial number together with any other information on the specification plate fitted to your appliance.

XV Warranty Medela AG warrants the BiliBed will be free from defects in materials and workmanship for a period of 2 years from the date of delivery ex works. Faulty material will be replaced free of charge during this period if not resulting from abuse or misapplication. This will not apply to parts subject to wear and tear in use, for example, the fluorescent tube, plastic cover, therapy blanket, etc. To ensure compliance with this warranty as well as optimum service from Medela products, we recommend the exclusive use of Medela accessories with our appliances. In no event shall Medela AG be liable for claims which exceed the scope of warranty described including liability for consequential damages, etc. The right to the replacement of faulty parts will not be recognized by Medela if any work has been carried out on the pump by unauthorized persons. This warranty is subject to the appliance being returned to a Medela service centre. Regulations according to IEC 601.1 (issued 1990) – Appendix A – § 6.8.2b The manufacturer may only be held liable for the safety, reliability and suitability for use of the appliance if the following conditions are fulfilled: • Installation, additions, readjustments, modifications or repairs have been carried out solely by persons authorized by the manufacturer. • The electrical installations in the room concerned satisfy the relevant specifications. • The appliance is used in conformity with these instructions for use. It is a general condition of use that the appliance will be operated under the supervision of qualified or authorized staff and that the user is in possession of the specialist knowledge required by any specific medical application for which the Medela BiliBed is used.

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Technical Documentation Technical Description Electromagnetic Compatibility (EMC, IEC 60601-1-2) IEC 60601-1-2, Table 201 Electromagnetic Emissions The BiliBed® is intended for use in the electromagnetic environment specified below. The customer or the user of the BiliBed should assure that it is used in such environment. Emission Tests

Compliance

Electromagnetic environment-guidance

RF emissions CISPR 11

Group 1

The BiliBed 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

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 60000-3-3

Complies

The BiliBed 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.

Warning: The BiliBed should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the BiliBed should be observed to verify normal operation in the configuration in which it will be used.

IEC 60601-1-2, Table 202 Electromagnetic Immunity The BiliBed is intended for use in the electromagnetic environment specified below. The customer or the user of the BiliBed should assure that it is used in such environment. IEC 60601 test level

Compliance level

Electromagnetic environment-guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

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 for power supply lines ± 1 kV for input/output lines

± 2 kV for power supply lines ± 1 kV for input/output lines

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

Surge IEC 61000-4-5

± 1 kV differential mode ± 1 kV differential mode ± 2 kV common mode ± 2 kV common mode

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

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

for 5 sec

3 A/m

3 A/m

Immunity Tests

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

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT)

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

Power frequency magnetic fields should be at levels of a typical commercial or hospital environment.

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

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IEC 60601-1-2, Table 204 Electromagnetic Immunity The BiliBed is intended for use in the electromagnetic environment specified below. The customer or the user of the BiliBed should assure that it is used in such environment. Immunity Tests

IEC 60601 test level

Compliance level

Electromagnetic environment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the BiliBed, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

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

3 Vrms 150 kHz to 80 MHz

3 Vrms

3 V/m 80 MHz to 2.5 GHz

3 V/m

d= 1.2 P d= 1.2 P d= 2.3 P

80 MHz to 800 MHz 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:

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 RF 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 BiliBed is used exceeds the applicable RF compliance level above, the BiliBed should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating the BiliBed. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

IEC 60601-1-2, Table 206 Recommended separation distance between portable and mobile RF communications equipment and the BiliBed The BiliBed is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BiliBed can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BiliBed as recommended below, according to the maximum output power of the communications equipment. Electromagnetic environment-guidance

Rated maximum output power of transmitter W

150 kHz to 80 MHz

0.01

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d= 1.2 P

d= 2.3 P

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

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23

d= 1.2 P

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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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INTERNATIONAL SALES

Medela AG, Medical Technology Lättichstrasse 4b 6341 Baar/Switzerland Phone +41 (0)41 769 51 51 Fax +41 (0)41 769 51 00 [email protected] www.medela.com

ITALY

Medela Italia Srl Via Turrini, 19 - Loc. Bargellino 40012 Calderara di Reno (BO) Phone + 39 051 72 76 88 Fax + 39 051 72 76 89 [email protected] www.medela.it JAPAN

SPAIN & PORTUGAL

Productos Medicinales Medela, S.L. c/ Manuel Fernández Márquez, 49 08918 Badalona (Barcelona) Spain Phone +34 93 320 59 69 Fax +34 93 320 55 31 [email protected] www.medela.es

Medela Pty Ltd, Medical Technology 3 Arco Lane, Heatherton Vic 3202, Australia Phone +61 (0) 3 9552 8600 Fax +61 (0) 3 9552 8699 [email protected] www.medela.com.au

Medela K.K. KDX Kiba Building 3F 5-12-8, Kiba, Koto-ku, Tokyo 135-0042 Japan Phone +81 3 3820-5187 Fax +81 3 3820-5181 [email protected] www.medela.jp

Medela Medical AB Box 7266 187 14 Täby Phone +46 (0)8 630 09 40 Fax +46 (0)8 630 09 48 [email protected] www.medela.se

CANADA

NETHERLANDS/BELGIUM

SWITZERLAND

AUSTRALIA

SWEDEN

Medela Inc. 4160 Sladeview Crescent, Unit # 8 Mississauga, Ontario Canada, L5L 0A1 Phone +1 905 608 7272 Fax +1 905 608 8720 [email protected] www.medela.ca

Medela Benelux BV De Steenbok 12 5215 ME 's-Hertogenbosch Netherlands Phone +31 73 690 40 40 Fax +31 73 690 40 44 [email protected] / [email protected] www.medela.nl / www.medela.be

CHINA

POLAND

Medela Poland Sp. z o. o. 03-684 Warszawa Ul.Lewinowska Phone +48 22 864 38 65 Fax +48 22 865 12 50 [email protected] www.medela.pl

Medela UK Ltd. Huntsman Drive Northbank Industrial Park Irlam, Manchester M44 5EG Phone +44 870 950 5994 Fax +44 870 389 2233 [email protected] www.medela.co.uk

RUSSIA

USA

Medela (Beijing) Medical Technology Co., Ltd. Unit M, 4F, No 1068 Wuzhong Road, Minhang District Shanghai 201103 / China Phone +86 21 62368102 Fax +86 21 62368103 [email protected] www.medela.cn FRANCE

Medela France Sarl 14, rue de la Butte Cordière 91154 Etampes cedex Phone +33 (0)1 69 16 10 30 Fax +33 (0)1 69 16 10 32 [email protected] www.medela.fr

OOO Medela Vavilova str. 97, entrance 3 117335 Moscow Russia Phone +7 (495) 980 6194 Fax +7 (495) 980 6194 [email protected] www.medela-russia.ru

Medela AG, Medizintechnik Lättichstrasse 4b 6341 Baar/Switzerland Phone +41 (0)848 633 352 Fax +41 (0)41 769 51 00 [email protected] www.medela.ch UNITED KINGDOM

Medela, Inc. P.O. Box 660 1101 Corporate Drive McHenry, IL. 60050 / USA Phone +1 877 735 1626 Fax +1 815 363 2487 [email protected] www.medelabreastfeedingus.com

© Medela AG/190.1030/09.10/D

GERMANY & AUSTRIA

Medela Medizintechnik GmbH & Co. Handels KG Postfach 1148 85378 Eching/Germany Phone +49 (0)89 31 97 59-0 Fax +49 (0)89 31 97 59 99 [email protected] www.medela.de