Medela BiliBed Instructions For Use Manual

Typ
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
7
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
1
2
3
4
5
6
7
8
9
10
8
9
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.
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.
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
9
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
10
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
11
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
13
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
14
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
15
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
EN
16
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.
17
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
18
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.
19
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 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 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, wodoodporpłytką 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
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Medela BiliBed Instructions For Use Manual

Typ
Instructions For Use Manual

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