Medela BiliBed Instructions For Use Manual

EN Instructions for use | PL Instrukcja obsługi | CS Návod k použití

HU Használati utasítás | RU Инструкция по применению

BiliBed

3

EN

4

Instructions for use

PL

18

Instrukcja obsługi

CS

HU

RU

32

Návod k použití

46

Használati utasítás

60

Инструкция по применению

EN

4

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.

We would like to thank you for the confidence you have placed into our company

by purchasing this product.

Medela AG reserves the right to change technical

specifications for the improvement of the product

at any time without prior notice.

5

EN

Working with the BiliBed requires precise knowledge of its areas of application as

well as adherence to these instructions. The product is intended for use only by

persons qualified in its areas of medical application. Also carefully instructed

delegates with support from and monitored by qualified individuals can operate the

Bilibed. The Bilibed should only be used in a healthcare environment.

Caution

The BiliBed may not be used:

• inside an incubator or warming bed;

• in environments where there is a risk of explosion;

• in environments that are enriched with oxygen.

Attention

The use of the Bilibed for anything but its intended purpose can be hazardous.

Portable and mobile RF communication devices may influence the Bilibed.

Separation from the mains is only assured through the disconnection of the plug

and socket connection.

The Bilibed is to be set up in such a way that a separation from the mains supply

can be easily managed.

A small percentage of the population is sensitive to blue light. It is known that blue

light may harm the retina in some cases. If you use the Bilibed in combination with

the Bilicombi therapy blanket according to the instructions in this manual, there

should be no leakage of blue light. The light used in the BiliBed is focused directly

on the baby. No disturbing light reaches the caregivers.

However, if the Bilicombi therapy blanket is not positioned correctly, leaking of blue

light may possibly occur. This may cause nausea, headaches or eye irritation for

blue-light sensitive caregivers.

The lamp used in the Bilibed emits blue light in the wavelength of 425–475. You

may want to avoid prolonged use/exposure if:

•

you have a pre-existing ocular condition such as macular degeneration;

•

you are diabetic of otherwise at risk for retinal damage;

•

you are taking photosensitizing medication;

•

you are 55+ years.

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

The service life of Bilibed is seven years if used normally.

You have to change the light tube in a 1500 hour-interval (see chapter X

Maintenance for more details). Besides the light tube, there are no user-serviceable

parts inside the Bilibed. Repairs must be performed only by an authorised service

agency. Do not repair yourself! No modifications to the device are permitted.

Safety noteI

MAX.

7 years

EN

6

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.

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.

Warning

A rapidly rising bilirubin level may require a more intensive therapy.

Contra-indications

The BiliBed shall not be used in cases where the baby has congenital porphyria or

if there is a family history of porphyria. Furthermore, the Bilibed must not be used

in the case of concomitant use of drugs or agents that are photosensitizers.

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

resettable and helps determine the time for changing the light tube. The “h“-meter

is resettable 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.

EquipmentIV

ApplicationsIII

DescriptionII

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EN

5.1 Light unit

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.

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.

5.2 Baby support

Preparation of the frame:

• Press the two red buttons underneath the frame at the

same time and raise the side of the frame.

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.

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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AssemblyV

EN

8

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.

Important

The baby support must be positioned correctly to ensure that

the baby is in the correct position for treatment.

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 ther-

apy lamp and its head must be positioned according to the

drawing on the light unit.

Warning

Sufficient air must circulate around the BiliBed (total ventila-

tion 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.

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2

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5

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10

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8

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

6.1 Installation of the light unit

• Remove the mattress from the cot. It will not be needed.

• Place the BiliBed light unit in the baby‘s cot. To make sure that sur-

rounding panels protect the baby, never use the BiliBed without a cot.

• 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.

Important

Sufficient air must circulate around the BiliBed. This is insured if the base of the cot

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 ventila-

tion openings must have a minimum area of 20 cm

2

, 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 accord-

ing to our instructions.

Installation of the BiliBed in the hospital cotVI

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EN

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

Irradiation, effective surface area

E

bi max (400–550nm)

= max. irradiation in a central area

Effective surface area: within this area E

bi

≥ 0.4 E

bimax

Room temperature: (25± 2) °C

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.

spectral irradiation [w/m

2

/5nm]

with baby support

with baby support & Bilicombi

Wavelength [nm]

Maximum values

E

bi max (400–550nm)

= 49.1 W/m

2

Average values

E

bi max (400–550nm)

= 33.9 W/m

2

Effective surface area 21 × 27 cm

Head end

Corresponds to the effective surface area with measured spots

Corresponds to the BiliCombi

Corresponds to the cut-out sector of the Bilicombi

Foot end

Irradiation levelsVII

EN

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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 maxi-

mum 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 for 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.

TherapyVIII

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EN

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.

EN

12

The BiliBed is equipped with two hour meters. When the fluo-

rescent 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.

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.

Note

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

1

1) Hour meters

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

Recommended hours

Actual hours

Date of change

Signature

Hour metersIX

MaintenanceX

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EN

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.

EN

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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 dis-

posed of in accordance with local regulations. The fan, lamp and electric parts

should be disposed of separately.

12.1 Light unit

Power supply Power adapter (TR30RAM120):

Input: 100 – 240V AC, ~47-63Hz , 0.8–0.4A

Output: 12V DC, 2.5A

Irradiation with compact fluorecent lamp

(according to IEC 60601-2-50) (Osram Dulux L18W/71)

E

bi max

= 49 W/m

2

Tube life approx. 1500 hours

Air pressure 70 – 106 kPa

Relative operating humidity 20 – 80%

Relative storage and transport 20 – 95%

humidity

Operating temperature +5 to +30 °C

Storage and transport temperature –20 to +50 °C

Noise level <20 dB(A)

12.2 Baby support

• Outer dimensions 630 × 326 × 42 mm

• Cover material Skin-friendly polyurethane (PUR)

12.3 Complete device

• Total dimensions 630 × 326 × 134 mm

• Working conditions +5 °C to + 30 °C

• Storage conditions –20 °C to + 50 °C

• Weight 4.0 kg

12.4 Bilicombi

• Material 75% cotton, 25% polyester

• Light permeable fabric material 100% cotton

Electromagnetic Compatibility (EMC)

The Medela BiliBed is a medical device which complies with special safety mea-

surements concerning EMC and must be installed and made ready for use accord-

ing to the EMC information at the end of these instructions for use.

Portable and mobile RF communication devices may influence the device.

DisposalXI

Technical dataXII

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EN

Ensure that the patient is positioned correctly. The baby can be laid on his back, or

on his stomach, if the doctor recommends this, with its head towards the top,

according to the drawing on the light unit. We recommend placing the baby on its

back. If the baby is restless and active this will prevent any abrasions on its knees.

IP24

The BiliBed should not be used in an incubator.

On/Off switch for lamp.

This symbol indicates to follow the instructions for use.

This symbol indicates a type BF applied part.

This symbol indicates the protection against ingress of

solid foreign objects and against harmful effects due to

the ingress of water.

What the symbols meanXIII

13.1 Symbols

This symbol indicates the compliance with additional

USA and Canada safety requirements for medical elec-

trical equipment.

This symbol indicates do not dispose the device together

with unsorted municipal waste (for EU only).

This symbol indicates the compliance with the essential

requirements of the Council Directive 93/42/EEC of 14

June 1993 concerning medical devices.

This symbol indicates the manufacturer.

This symbol indicates the date of manufacture (four dig-

its for the year and two digits for the month).

This symbol indicates manufacturer’s serial number of

the device.

This symbol indicates manufacturer’s catalogue number.

This symbol indicates MR UNSAFE.

13.2 Symbols on the device

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This symbol indicates direct current.

This symbol indicates that the mains adapter is a class II

device.

This symbol indicates to not dispose the device together

with unsorted municipal waste (for EU only). The solid

bar symbol indicates that mains adapter is put on the

market after 13 August 2005.

This symbol indicates that the mains adapter is for

indoor use only.

13.4 Symbols on the packaging

This symbol indicates that the material is part of a reco-

very/recycling process.

This symbol indicates a carton package.

This symbol indicates to keep the device away from

sunlight.

This symbol indicates to handle the fragile device with

care.

This symbol indicates the temperature limitation for ope-

ration, transport and storage.

This symbol indicates the humidity limitation for operati-

on, transport and storage.

This symbol indicates the atmospheric pressure limitati-

on for operation, transport and storage.

This symbol indicates to keep the device dry.

This symbol indicates to transport, handle and store the

package in such a way that the arrows point upwards (‘This

way up‘).

13.3 Symbols on the power adapter

This symbol indicates the compliance with Japanese

safety requirements.

This symbol indicates the compliance with USA and

Canada safety requirements.

This symbol indicates the compliance with the essential

requirements of the Council Directive 93/42/EEC of 14

June 1993 concerning medical devices.

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EN

The Medela BiliBed consists of a light unit, a start/stop switch and a baby support

with a plastic cover. The following spare parts are available:

038.4001 BiliBed (including two washable Bilicombi therapy blankets)

099.0115 Fluorescent tube, 10 pcs

099.0116 Fluorescent tube, single

099.0144 Plastic cover, 5 pcs

099.0143 Plastic cover, single

800.0229 Therapy blanket Bilicombi, washable

800.0860 Therapy blanket Bilicombi, disposable

Detailed service documentation including circuit diagrams, spare parts list, etc. are

available on request from Medela or from your local Medela agent. Only authorised

persons can order service documents. Please give the relevant serial number

together with any other information on the specification plate fitted to your

appliance.

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 fluo-

rescent 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 product by unauthorized persons. This warranty is subject to the

appliance being returned to a Medela service centre.

The Bilibed must be operated only by persons qualified in the areas of medical

application for which the Medela Bilibed is used. Also carefully instructed delegates

with support from and monitored by qualified individuals can use the Bilibed.

Ordering referencesXIV

WarrantyXV

PL

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Szanowny Kliencie!

Pragniemy pogratulować zakupu urządzenia BiliBed

®

firmy Medela. Jesteśmy

pewni, że dokonali Państwo właściwego wyboru i będą Państwo w pełni

zadowoleni.

Poniżej przedstawiamy sposób użytkowania i konserwacji urządzenia BiliBed.

W przypadku ścisłego przestrzegania poniższych instrukcji, urządzenie BiliBed

będzie służyło długo i bezawaryjnie.

Pragniemy podziękować za zaufanie, którym Państwo obdarzyli naszą firmę,

kupując ten produkt.

Medela AG zastrzega sobie prawo do zmiany

specyfikacji technicznej w celu poprawy produktu w

dowolnym czasie, bez wcześniejszego powiadomienia.

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PL

Praca z urządzeniem BiliBed wymaga precyzyjnej wiedzy na temat obszarów

jego zastosowań oraz przestrzegania poniższych instrukcji. Ten produkt jest

przeznaczony do użytku wyłącznie przez osoby wykwalifikowane w zakresie

danego zastosowania medycznego. Urządzenie mogą również obsługiwać

osoby wyznaczone przy wsparciu i pod nadzorem osób wykwalifikowanych.

Urządzenie Bilibed można stosować wyłącznie w placówkach ochrony zdrowia.

Przestroga

Urządzenia BiliBed nie można stosować:

• wewnątrz inkubatorów ani w podgrzewanych łóżeczkach;

• w środowiskach, w których występuje niebezpieczeństwo wybuchu;

• w pomieszczeniach o podwyższonej zawartości tlenu.

Uwaga

Użycie urządzenia do innych celów niż do tych, do których jest ono przeznaczone

może być niebezpieczne.

Na urządzenie Bilibed wpływ mogą wywierać przenośne i mobilne urządzenia

łączności radiowej (emitujące promieniowanie o częstotliwości radiowej).

Odłączenie od napięcia sieciowego następuje przez wyjęcie wtyczki.

Urządzenie Bilibed należy ustawić w taki sposób, aby można było łatwo

odłączyć wtyczkę od źródła zasilania.

Niewielki procent populacji jest wrażliwy na niebieskie światło. Wiemy, że światło

niebieskie może w niektórych przypadkach powodować uszkodzenia siatkówki.

Jeśli urządzenie Bilibed będzie stosowane w połączeniu z kombinezonem terapeu-

tycznym Bilicombi zgodnie z instrukcjami podanymi w niniejszym podręczniku,

wyciek światła o barwie niebieskiej nie powinien występować. Światło używane w

lampie BiliBed jest skoncentrowane bezpośrednio na dziecku. Żadne powodujące

dyskomfort promieniowanie nie dociera do opiekunów.

Jednak w przypadku nieprawidłowego ustawienia kombinezonu terapeutycznego

może wystąpić przeciek światła o barwie niebieskiej. Może to powodować nudno-

ści, bóle głowy i podrażnienia oczu u opiekunów wrażliwych na niebieskie światło.

Lampa stosowana w urządzeniu Bilibed emituje niebieskie światło o długości fali

425–475. Należy unikać długotrwałego stosowania/ekspozycji na to światło, jeśli

osoba wystawiona na działanie:

•

zgłasza przebyte schorzenia oczu, takie jak zwyrodnienie plamki żółtej oka;

•

jest diabetykiem lub istnieje inne ryzyko uszkodzenia siatkówki;

•

stosuje leki zwiększające wrażliwość na światło;

•

ma powyżej 55 lat.

Nigdy nie należy używać urządzenia BiliBed bez kombinezonu Bilicombi.

W każdym z podanych poniżej przypadków urządzenia nie wolno uruchamiać i

wymaga ono naprawy przez serwis:

• jeśli kabel zasilający lub wtyczka są uszkodzone;

• jeśli urządzenie nie pracuje prawidłowo;

• jeśli urządzenie jest uszkodzone;

• jeżeli urządzenie wykazuje wyraźne wady w zakresie bezpieczeństwa.

Przy normalnym użytkowaniu trwałość urządzenia Bilibed wynosi siedem lat.

Świetlówkę należy wymieniać co 1500 godzin pracy (szczegóły na ten temat

znajdują się w rozdziale X — Konserwacja). Oprócz świetlówki urządzenie Bilibed

nie zawiera części, które mogą być serwisowane przez użytkownika. Naprawy

mogą być wykonywane wyłącznie przez autoryzowany serwis. Nie naprawiać

urządzenia samodzielnie! Nie dopuszcza się żadnych modyfikacji urządzenia.

Uwagi dotyczące bezpieczeństwaI

MAX.

7 years

PL

20

Urządzenie BiliBed firmy Medela to nowoczesny, wysokiej jakości system do

fototerapii. Opracowano go wykorzystując najnowsze wyniki badań medycznych

z zakresu leczenia hiperbilirubinemii u noworodków. Urządzenie BiliBed pasuje do

większości dostępnych obecnie łóżeczek szpitalnych. Z tego względu urządzenie

nadaje się szczególnie dobrze do stosowania w systemach matka przebywająca z

dzieckiem (rooming-in). Łóżeczka do fototerapii pracują przy bardzo niskim zużyciu

energii. Koszty dalszej obsługi są również niezwykle niskie, ponieważ wymianie

podlega wyłącznie jedna świetlówka fluoroscencyjna światła niebieskiego.

Wskazania

Urządzenie BiliBed firmy Medela zaprojektowano z myślą o prowadzeniu wydajnej

i bezpiecznej terapii zbyt wysokich stężeń bilirubiny w osoczu u noworodków.

Terapia przy pomocy BiliBed zalecana jest u noworodków, które nie wymagają

stosowania inkubatorów i tych, u których nie występują dodatkowe powikłania.

Ostrzeżenie

Szybko rosnące stężenie bilirubiny może wymagać wdrożenia bardziej intensywnej

terapii.

Przeciwwskazania

Urządzenie BiliBed nie powinno być stosowane w przypadkach, gdy dziecko

cierpi na wrodzoną porfirię lub w przypadku występowania porfirii w wywiadzie

rodzinnym. Urządzenia Bilibed nie można również stosować w przypadku

jednoczesnego stosowania leków lub środków zwiększających wrażliwość

na światło (środki fotoalergizujące).

Moduł świetlny składa się z wypolerowanego reflektora aluminiowego i energoo-

szczędnej świetlówki emitującej niebieskie światło. Cichy wentylator rotacyjny

zapewnia niezbędną wymianę powietrza wokół świetlówki fluoroscencyjnej.

Świetlówka specjalna emituje głównie światło o długości fali 425–475 (światło

niebieskie).

Moduł świetlny urządzenia BiliBed zawiera dwa liczniki godzin. Licznika godzin

całkowitych (total h) nie można wyzerować i jego zadaniem jest pomoc

w określaniu czasu wymiany świetlówki fluoroscencyjnej. Licznik godzin (h)

można zerować i wskazuje on czas terapii.

Moduł świetlny, który zawiera elementy emitujące promieniowanie i elektronikę,

jest osłonięty przezroczystą, wodoodporną płytką z pleksi.

Powierzchnia składa się z aluminiowej ramy pokrytej przezroczystą, przyjazną

dla skóry osłoną z plastiku wykonaną z poliuretanu (PUR).

Optymalne ułożenie dziecka w urządzeniu BiliBed zapewnia kombinezon terapeu-

tyczny (Bilicombi). Światło jest kierowane na dziecko przez przepuszczalny dla

światła materiał znajdujący się od spodu kombinezonu terapeutycznego. Zapewnia

to optymalną terapię i chroni otoczenie przed zakłóceniami niebieskim światłem.

Nie należy nigdy zmieniać ani wymieniać materiału przepuszczającego światło

kombinezonu Bilicombi! W innym przypadku nie można zagwarantować efektu

terapeutycznego.

Sprzęt

IV

ZastosowanieIII

OpisII

Stránka sa načítava ...

Medela BiliBed Instructions For Use Manual

Medela BiliBed Instructions For Use Manual

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