Medela BiliBed User manual

EN Instructions for use
ES Manual de instrucciones
PT Manual de instruções
EL Οδηγίες χρήσης
BiliBed

3
EN
PT
ES
EL
5
Instructions for use
29
Manual de instruções
17
Manual de instrucciones
41
Οδηγίες χρήσης

5EN
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
• 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
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.
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.
ISO International Organisation for Standardization
EN European Norm
FDA Food and Drug Administration
GMP Good Manufacturing Practices
Medela AG reserves the right to change technical
specifications for the improvement of the product
at any time without prior notice.
Safety NoteI

EN6
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.
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.
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.
EquipmentIV
ApplicationsIII
DescriptionII

7EN
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.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
1
2
3
4
5
6
7
8
9
10
8
9
AssemblyV

EN8
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.
1
1
2
3
4
5
5
6
10
9
7
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.
Warning
The BiliBed is not designed for use in an incubator. Do not use the BiliBed without
a baby crib or bassinet.
• 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.
Installation of the BiliBed in the hospital cotVI

9EN
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
Ebimax(400–550nm)  =max.irradiationinacentralarea
Effective surface area: within this area Ebi ≥0.4 Ebimax
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.
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.
spectralirradiation[w/m2/5nm]
with baby support with baby support & Bilicombi
Wavelength[nm]
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
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

EN10
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 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.
TherapyVIII