Instructions

Instructions
© Medela AG/200.0100/07.10/C
Medela® BiliBed®
EN Instructions for use
I
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
• 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 persons authorized by Medela:
• If the power cable or the plug are damaged
• If the device is not functioning properly
• If the device is damaged
• If the device shows clear safety defects
II
Description
Medela’s BiliBed is a modern, quality phototherapy system. It has been developed
according to the latest medical findings for the treatment of neonatal hyperbilirubinaemia.
Because the BiliBed can be fitted to most baby cribs or hospital bassinets, it is very
suitable for hospital rooming-in or home phototherapy. 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.
EN
1
III Application
Indications
Medela’s BiliBed is designed for the efficient and safe treatment of excessive
serum-bilirubin concentrations in newborn babies. It is not intended to prevent this
condition. It is indicated for use for all babies which do not require treatment in an
incubator and have no further complications.
Contra-indications
Babies with rapidly rising bilirubin levels must be monitored frequently and 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 air exchange around the
fluorescent tube. The special tube emits light mainly in the 425 – 475 nm range.
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 passed therapy time.
The light unit, including the irradiation and the electronics, is covered with a
transparent, waterproof, Perspex plate.
Bilicombi therapy blanket
The baby support is comprised of an aluminum frame covered with a transparent
polyurethane (PUR) plastic.
For optimum positioning of the baby, the BiliBed has a Bilicombi™ therapy blanket.
The light is directed at the patient through the white fabric below the therapy
blanket. This permits optimum treatment and protects surroundings from disturbing
blue light. Never alter or exchange the white fabric of the Bilicombi! The therapeutical
effect cannot be guaranteed when this is done.
Baby support
Light unit
2
EN
The Bilicombi therapy blanket helps keep the baby warm and properly positioned.
The Bilicombi is fastened onto the baby support and allows the therapeutic light to
focus directly on the baby through the white fabric section on the underside of the
therapy blanket.
V
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 adapter, the
START/STOP switch can be plugged into 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 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.
2
5
3
4
5.2 Baby support
7
9
Preparation of the frame:
• Press the two red buttons underneath the frame at the same time and raise the side of the frame.
8
9
8
10
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.
1) Head of BiliBed
2) Hour meters
3) Start/Stop switch
4) 12V DC power adapter
5) Socket
6) Foot end of BiliBed
7) Plastic cover
8) Button
9) Groove
10) Aluminum frame
EN
3
VI Installation in the baby’s crib or the hospital bed
6.1 Installation of the light unit
• Remove the mattress from the baby’s crib or the bassinet.
Warning
The BiliBed ® was 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
surrounding 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 START/STOP switch through the openings in the base of the crib. If there are no openings in the base, pass the power cord over the edge of the crib at the foot end.
• Connect the power cord to a two-prong grounded outlet at 120 VAC.
An extension cord can be used if necessary (minimum 0.25A grounded).
• The light unit can be switched on or off with the START/STOP switch. When the
switch is turned off, the BiliBed is still connected to the power supply. The
equipment is only completely switched off when the power cord is disconnected
from the power supply.
1
1
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. As soon as the
light unit is plugged in, the “total h“ and “h“-meter are started. For resetting the
“h“-meter, however, the START/STOP switch is necessary (see chapter 9).
2
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.
3
4
4
EN
Important
The baby support must be positioned exactly to ensure that the baby is in the
correct position for treatment.
6.3 Installation of the Bilicombi™ therapy
blanket
• Fasten the Bilicombi blanket to the baby support by
aligning the wide, white strips of of Velcro ® under the
Bilicombi with the four Velcro tabs on the baby support.
5
6
5
Important
The Bilicombi must be positioned correctly to ensure successful
treatment. The baby must lie above light unit with his/her head
corresponding to the drawing on the light unit.
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9
10
8
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.
Lay the baby on his/her back unless the physician orders
otherwise.
You should talk to the doctor about which sleeping position is
best for the new baby. There are certain health conditions that
might require tummy-down sleeping positions. If the baby was
born with a birth defect, was born pre-term, frequently spits
up after eating or has breathing, lung or heart problems, be
sure to talk to the doctor about which sleeping position to use.
Baby support
1) Twin Velcro strips
Light unit
2) Head of BiliBed
3) Foot of BiliBed
4) Start/Stop switch
Bilicombi therapy blanket
5) Flaps
6) Wide strips of Velcro
Baby support
7) Head of BiliBed
8) Velcro strips
9) Plastic cover
10) Foot of BiliBed
EN
5
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 Ebi max
(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.
6
EN
7.1 Measuring the irradiance
Measuring the light irradiance is not required as long as the light tube is changed every
1,500 hours. Should your facility require regular measurements a radiometer capable of
measuring fluorescent light in the 425 – 475nm light spectrum with intensity greater than
40µW/cm2/nm is required. The Olympic Medical Bili-Meter Model 22 with Type B-22
sensor is recommended.
Place the meter in the area of highest irradiation, as shown above in square 5. Move
the meter around this area to find the spot of highest irradiation. This is the only
required point at which a measurement needs to be taken. Once found, press down
slightly to simulate the weight of the baby on the bed and take a final reading. A
typical measurement will read between 40 – 60 µW/cm2 /nm. When using a new
fluorescent tube it is expected to have a much higher reading. This is of no harm to
the baby and quickly plateaus to the typical range. Though a light tube with >1,500
hours of use may measure in the 40 – 60 µW/cm2/nm range it should still be
changed to maintain an optimal therapeutic affect.
VIII Providing phototherapy
8.1 Dressing the baby
• All of the baby’s clothes should be removed for maximum skin exposure to the
light. If a diaper is recommended, 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.
• Some other types of phototherapy equipment require infant eye patches. There
is no need to cover the baby‘s eyes when the BiliBed is used according to
instructions.
8.2 Putting the baby in the Bilicombi™ 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.
• Always lay the baby on his/her back in the Bilicombi blanket unless the
physician tells you otherwise.
• You should talk to the doctor about which sleeping position is best for the new
baby. There are certain health conditions that might require tummy-down sleeping
positions. If the baby was born with a birth defect, was born pre-term, frequently
spits up after eating or has breathing, lung or heart problems, be sure to talk to
the doctor about which sleeping position to use.
• Put the baby‘s arms into the sleeves of the Bilicombi blanket.
• Zip/Fasten Velcro on the Bilicombi blanket. Close the Velcro fastener under the
baby‘s chin.
EN
7
VIII Providing phototherapy
Caution
During phototherapy, do not raise the baby’s legs or head. The BiliBed should only be
used with baby lying down.
Caution
Frequently check on the baby during phototherapy treatment. If the baby seems too
warm, make sure there is adequate air circulation, 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 tight and sags, a new support
should be used. The support can carry a weight of up to 10 kg. For heavier babies we
recommend using the Medela Phototherapy Lamp.
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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EN
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 (in a 4-second interval).
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
(recommended: every 1,500 hours).
1
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 light tube should be replaced.
Note
Both displays only light up when the BiliBed is plugged in.
1) Hour meters
X
Maintenance
10.1 Changing the light tube
Change the light tube every 1,500 hours. 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 this card 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
Actual hours
Aktuelle Stunden
Nb. heures réel
Total horas consumidas
Date of change
Datum
Date
Fecha
Signature
Unterschrift
Signature
Firma
EN
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X
Maintenance
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.
Warning
Use only Medela replacement light tubes, otherwise the safety and success of the
therapy cannot be guaranteed! We recommend changing the light tube every
1,500 hours in order to guarantee therapeutic effectiveness.
• Readjust metal clamp for a secure hold.
• If the reflector is not clean and shiny, wipe with a dry cloth.
• Refit the light unit cover with the 10 screws.
10.2 Cleaning and disinfecting
A Light Unit and Baby Support Cleaning
• 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.
B 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 the 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 minutes is
recommended.
• Machine wash in hot water. Minimum temperature 140 degrees F (60 °C).
Maximum temperature 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 BilicombiTM by 75%.
• 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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EN
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 specifications
12.1 Light unit
UL Listed
Power supply
Power consumption
Irradiation
Tube life
Air pressure
Relative humidity
Operating temperature
Storage/transport temperature
Noise level
Standards
to UL 2601.1
12V DC through power adapter 100– 240V
~47-63Hz
30 W
Ebi max = 49 W/m2 (according to IEC 60601-2-50)
with compact fluorecent lamp
(Osram Dulux L18W/71 or
Radutec long 18W/71/2G11)
Approx. 1,500 hours
70 –106 kPa
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)
IEC 60601-2-50:2000
12.2 Baby support
Cover
Weight
polyurethane (PUR) plastic
1.2 kg (2 lbs, 10 oz)
12.3 Washable Bilicombi™ therapy blanket
Material excluding trim
White fabric material
75% cotton, 25% polyester
100% cotton
IPX4
12.4 Disposable Bilicombi™ therapy blanket
Top Material excluding trim
White fabric material
100% nonwoven spunlaced fabric
100% cotton
12.5 Complete device
Dimensions:
Length
Width
Height
Weight
Working conditions
Storage and transport conditions
63 cm (24.8 inches)
32.6 cm (12.8 inches)
13 cm (5.1 inches), including baby support
4 kg (9 lbs)
+5 °C to +30 °C
–20 °C to +50 °C
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.
EN
11
XII Technical specifications
12.6 Key to symbols
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
IPX4
Medela BiliBed
With respect to electric shock, fire, and mechanical hazards only
In accordance with UL 60601-1/CAN/CSA C22.22 No. 601.1/
IEC 60601-2-50
Model B unit
IPX4
Protection against splashing water
Power adapter
Direct current
IPX4
Protection class II
Must not be disposed of together with household refuse
For indoor use only
12
EN
XIII Ordering references
Article #
038.4002
Purchased Medela ® BiliBed ®
consisting of a light unit, power cord, Start/Stop switch and a baby support with a plastic cover, Instructions for Use, Service Manual, 1 each
038.4002R
Rental Medela BiliBed
Includes all above plus Carrying Case
936.0015
Compact fluorescent tube, 1 each
800.0229
800.0336
Bilicombi™ washable therapy blanket, 1 each
Bilicombi disposable therapy blanket, 10 per case
808.0018
Plastic cover, 1 each
190.0549
200.0100
190.7337
Parent’s Guide to Home Phototherapy, 1 each
Instructions for Use
Baby’s Phototherapy Log, 100 each
800.0341
BiliBed Carrying Case
XIV Warranty
The BiliBed is warranted by Medela to the original purchaser to be free from defects in
material and workmanship for the period of 2 years from the date of delivery. In the
event of defect or failure to conform to this warranty, Medela will repair or, at Medela’s
option, replace this product.
This warranty does not apply to the normal wear and use of the product or the accessories such as the light tube, plastic cover, Bilicombi therapy blanket, etc. This warranty
does not apply to product, which has been subject to misuse, abuse or alteration.
EN
13
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
<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
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
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A /m
3 A /m
Power frequency magnetic fields should be at levels
of a typical commercial or hospital environment.
Immunity Tests
NOTE UT is the a.c. mains voltage prior to application of the test level.
14
EN
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 V/m
80 MHz to 2.5 GHz
d= 1.2 P
d= 1.2 P
d= 2.3 P
3 Vrms
3 V/m
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 erscht
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
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d= 1.2 P
d= 1.2 P
d= 2.3 P
0.01
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
12
23
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.
EN
15
Medela, Inc.
P.O. Box 660, McHenry, IL 60051-0660, USA
4090B Sladeview Cres., Unit 2, Mississauga, Ontario, Canada L5L, 5Y5
Phone 800-435-8316 or 815-363-1166. Fax 815-363-1246
©2006 Medela. All rights reserved. Made in Switzerland.
BiliBed and Medela are registered trademarks and Bilicombi and Natural solutions
for beautiful beginnings are trademarks of Medela. Velcro is a registered trademark of
Velcro Industries. Cavicide is a registered trademark of Micro. Aseptic Products, Inc.
16
EN
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