BiliBed Parents Guide July 2007

BiliBed7 - Parent’s Guide to Home Phototherapy Page

1.

Safety Note ...4

2.

Introduction ...5

3.

What is jaundice? ...5

4.

What is bilirubin? ...5

5.

Treating jaundice in newborns...6

6.

Home phototherapy ...6

7.

What is the Medela7 BiliBed7 ? ...7

8.

Parts ...7

9.

Assembly of the BiliBed7 ...8 9.1 Assembly of the light unit ... 8 9.2 Assembly of the baby support... 8

10. Installation in the baby’s crib or the bassinet ...9 10.1 Installation of the light unit ... 9 10.2 Installation of the baby support... 9 10.3 Installation of the BilicombiJ therapy blanket ... 10

11. Providing Phototherapy ...11 11.1 Dressing the baby ... 11 11.2 Putting the baby in the BilicombiJ blanket... 11

12. Caring for your baby during Phototherapy...13 12.1 Bowel movements... 13 12.2 Urination... 13 12.3 Breastfeeding... 13 12.4 Bottle feeding ... 13 12.5 Baby's temperature... 14 12.6 Baby's skin ... 14

13. How long will the BiliBed7 be needed?...14

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14. Warning Signs ...14 15. Cleaning the BiliBed ...15 15.1 Light unit and baby support cleaning ... 15 15.2 BilicombiJ therapy blanket... 15

16. Technical specifications for series 038 ...16 16.1 Light unit ... 16 16.2 Baby support... 16 16.3 Complete device ... 16 16.4 Washable BilicombiJ Therapy Blanket... 16 16.5. Disposable Bilicombi Therapy Blanket ... 16 16.6 Key to symbols... 17

17. Ordering references...18

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1.

Safety Note Remarks Working with the BiliBed7 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 Nursing staff: This lamp emits blue light in the wavelength of 425-475 which may harm the retina in some cases. You may want to avoid prolonged use/exposure if: - you have a pre-existing ocular condition such as macular degeneration - you are diabetic or otherwise at risk for retinal damage - you are taking photosensitizing medication such as nonsteroidal anti-inflammatory drugs, most antidepressants, some antibiotics, diuretics and beta-blockers and other heart medications. - you are 55+ years of age 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. 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. Caution Federal law restricts the use of this device by order of a physician. Medela products are developed and produced with a certified quality-management system, in accordance with EN ISO 13485:2003, as well as 21 CFR 820 United States FDA Quality System Regulations (QSR’s). ISO International Organization for Standardization EN European Norm FDA Food and Drug Administration

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2.

Introduction Your baby is jaundiced. Undoubtedly, you were worried and upset when you heard these words. But by now, your doctor has calmed your worst fears and you know that it is a relatively common condition that can be effectively treated without drugs, surgery, separations or hospitalization. And by now, you realize the chances are great that within a few days your baby's bilirubin levels will be back to normal. As a further reassurance, it might be helpful for you to know just what jaundice is, how it happens, and how it is treated.

3.

What is jaundice? The term "jaundice" comes from the French word "jaune", which means "yellow". When a person is jaundiced, excess bilirubin (billy-roo-bin) has accumulated in their fatty tissues, especially in their skin, giving them a yellowish color, and the sclera (whites of the eyes).

4.

What is bilirubin? Bilirubin is nothing more than a naturally occurring component of the red blood cells in our bodies. It is released into the blood stream when the red blood cells naturally break down. This breaking down of the red cells goes on all the time as a normal part of the constant renewing of our bodies. In other words, we all have some bilirubin in us at all times. The amount or "level" of bilirubin usually is of no concern because our livers break down the bilirubin so that it will be excreted. In newborns, the story is a little different. Infants are born with extra red blood cells. These red blood cells provide the oxygen that is needed while the infant grows in the mother’s uterus. Once the baby is born, the extra red cells are broken down and bilirubin begins to build up. Newborns also have an immature liver that cannot effectively process the extra bilirubin like the adult liver does. This contributes to the temporary build-up of bilirubin in the skin. In all newborns, it is normal for bilirubin levels to rise during the first three or four days of life, peak, and then slowly decline. In a few babies - yours is one of them - the bilirubin rises beyond what is considered an acceptable level. This is not necessarily a problem in itself. However, extremely high bilirubin levels can be harmful. So your doctor, by ordering treatment for your baby, is prescribing phototherapy to prevent the level from rising to a dangerous level. With treatment, your baby’s bilirubin level should drop to the acceptable range within a few days.

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BILIRUBIN LEVEL (mg Bilirubin/ 100ml Plasma)

AGE (Days) Mean (= standard error of mean) Daily Serum Unconjugated Bilirubin Concentrations in 29 Healthy Full-Term Infants (Source: Gartner, L.: Neonatal Jaundice. Pediatrics in Review 1994;11:422-432)

5.

Treating jaundice in newborns One of the safest and most effective treatments for jaundice in newborns is phototherapy (photo = light + therapy = treatment). In phototherapy, light rich in blue rays (425 - 475 nm wavelength) causes the bilirubin to break down into a soluble form that can be excreted in the stool of the baby. This takes some of the burden off the liver and allows the baby to excrete large amounts of bilirubin while preventing its accumulation. It is a proven treatment that has been in use for over 20 years. The Medela7 BiliBed was developed to treat newborn jaundice and is not intended to prevent this condition.

6.

Home phototherapy Home phototherapy is a team effort involving the baby’s doctor, laboratory, the phototherapist, and you. The doctor has made the diagnosis - your baby has jaundice - and prescribed home phototherapy. The doctor has called in the phototherapist to actually deliver the treatment, but will communicate regularly with the phototherapist to be sure the treatment is going satisfactorily. The phototherapist is usually a licensed, registered nurse (RN) who has been specially trained in home phototherapy. The nurse’s role is to provide and set up the equipment, to instruct you on the usage of the equipment, to instruct you in your role in the treatment, to monitor the treatment, and to keep the doctor informed of the baby’s condition. During treatment, the phototherapist will visit you and your baby every day. The phototherapist will examine the baby, assess the baby’s feeding skills, draw blood samples for bilirubin levels, and discuss your baby’s progress with you and with your doctor.

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Your role in the treatment is as important as the role of the doctor and nurse. The phototherapist will show you how to use the equipment and will also teach you any necessary baby care techniques (such as taking the baby’s temperature). Babies often have dry skin after birth. If your baby’s skin condition worsens or red rashes appear during phototherapy, contact your baby’s doctor. Do not put any oils on your baby’s skin. Oils are never used during any phototherapy treatment. There is nothing difficult or unusual in what you will be doing, but it is very important for the success of the treatment and should be done faithfully. This booklet has been prepared to help you. Hopefully, it will answer all of your questions. If at any time you have additional questions or concerns about any aspect of home phototherapy, ask the phototherapist or the baby’s doctor.

7.

What is the Medela7 BiliBed7 ? Medela’s BiliBed is a modern, quality phototherapy system designed for the efficient and safe treatment of excessive bilirubin concentrations in newborn babies. It has been developed according to the latest medical findings for the treatment of newborn jaundice. Because the BiliBed can be fitted to most baby cribs or hospital bassinets, it is very suitable for home phototherapy. Warning The use of these light tubes for anything but their intended purpose can be hazardous.

8.

Parts BilicombiJ 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. Baby support The baby lies on a plastic baby support that fits over the light unit. Light unit The light unit is placed in the baby's crib or bassinet. This unit contains a special light tube, which provides the therapeutic blue-colored light. The light tube needs changing every 1500 hours. Please consult your phototherapist whether the light tube needs changing during your rental period. When the light unit is operating, a quiet fan keeps the air circulating around the light tube. The light unit is covered with a transparent, waterproof, plexiglass cover.

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9.

Assembly of the BiliBed7 9.1

Assembly of the light unit ¾

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 in to the socket in order to switch the fluorescent tube on and off.

1 Head of BiliBed 2 Hour meters 3 Start/Stop switch 4 12V DC power adapter 5 Socket 6 Foot end of BiliBed

9.2

Assembly of the baby support (this assembly may already be complete)

1 Plastic cover 2 Button 3 Groove 4 Aluminum frame

¾

Press the two red buttons on the underside of the frame at the same time and raise the side of the frame.

Fitting the plastic cover to the aluminum frame: ¾ 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.

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10. Installation in the baby’s crib or the bassinet 10.1 Installation of the light unit The BiliBed7 is intended for use in a crib or bassinet. Remove the mattress or if desired, a wooden board may be placed on top of the mattress. If a crib or bassinet is not available or doesn't have an even surface, the BiliBed may be placed on the floor in a room where the baby can be closely supervised. Warning Never use the BiliBed on a table or other piece of furniture, other than a crib or bassinet. Important Sufficient air must circulate around the BiliBed. This is ensured 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 be a minimum of 1/3 inch from each side of the bed, or about the space necessary to fit the width of a regular pencil or pen. If the space doesn't meet the requirements for proper air circulation, the flaps of the Bilicombi can be folded under the plastic surface of the Baby support. ¾ 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. ¾ Connect the power cord to a three-prong, grounded outlet at 120 VAC standard household voltage). An extension cord can be used if necessary (minimum 0.25A grounded). ¾ 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.

10.2 Installation of the baby support ¾ Place the baby support on top of the light unit so the two twin strips of Velcro7 on the plastic are next to the drawing of the baby’s head on the light unit. Important The baby support must be positioned exactly to ensure that the baby is in the correct position for treatment.

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Baby support 1 Twin Velcro strips Light unit 2 Head of BiliBed 3 Foot of BiliBed 4 Start/stop switch

10.3 Installation of the BilicombiJ therapy blanket ¾ Fasten the Bilicombi blanket to the baby support by aligning the wide, white strips of Velcro7 under the Bilcombi with the four turquoise Velcro tabs on the baby support.

Bilicombi therapy blanket 1 Flaps 2 Wide strips of Velcro

Baby support 3 Head of BiliBed 4 Velcro strips 5 Plastic cover 6 Foot of BiliBed

Important The BilicombiJ must be positioned correctly to ensure successful treatment. The baby must lie above the light unit with his/her head corresponding to the drawing on the light unit. Warning Sufficient air must circulate around the BiliBed (total ventilation openings must have a minimum area of about the space necessary to fit the width of a regular pencil or pen). If the space does not meet the requirements for proper air circulation, the flaps (see diagram above) of the Bilicombi can be folded under the plastic surface of the Baby support. Parent's Guide

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11. Providing Phototherapy Attention If you have any questions about phototherapy or this device, contact your healthcare professional or phototherapist.

11.1 Dressing the baby ¾ We always recommend using the smallest possible diaper (to avoid soiling of the Bilicombi therapy blanket) and to roll down the top below baby's naval so that the maximum amount of skin will be exposed to the therapeutic light. ¾ Some other types of phototherapy equipment require infant eye patches. There is no need to cover the baby's eyes when the BiliBed7 is used according to instructions.

11.2 Putting the baby in the BilicombiJ blanket Note The BiliBed is designed for use only with the original Medela Bilicombi blanket. The Bilicombi keeps the baby warm and correctly positioned for effective phototherapy. ¾

Attach the Bilicombi blanket to the baby support.

¾

Unzip the Washable Bilicombi blanket or unfasten the Velcro7 of the Disposable Bilicombi. Always lay the baby on his/her back in the Bilicombi blanket unless your healthcare professional 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 tummydown 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.

¾

Place the baby in the appropriate sleeping position.

¾

Put the arms of the baby into the sleeves of the Bilicombi blanket.

¾

Zip/Velcro the Bilicombi blanket. Close the Velcro fastener under the baby's chin.

Caution During phototherapy, do not raise the baby’s legs or head. The BiliBed should only be used with baby lying down. ¾

Frequently check on the baby during phototherapy treatment.

If the baby seems too warm: ¾ Parent's Guide

Make sure that there is enough room around the BiliBed for air to circulate. BiliBed7

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¾

Fold the flaps of the BilicombiJ under the plastic surface of the Baby support.

If the baby seems too cold: ¾

The Bilicombi blanket helps keep baby warm. If additional warmth is necessary, a blanket can be placed over the Bilicombi.

Caution If a blanket is placed over the Bilicombi, care should be taken to not block the circulation of air around the BiliBed7. Avoid blocking the airflow by keeping the blanket from hanging past the edges of the Bilicombi. Check the baby at regular intervals to be sure she/he's not getting too warm when covered with an extra blanket. BiliBeds with model numbers 0380015, 0380016, 0384002 and 0384002R: (Model numbers can be found on the bottom side of the BiliBed) These BiliBeds are equipped with two hour meters. When the fluorescent tube lights up, both will start counting. The blinking hourglass will indicate timer operation. The hour meter "total h" measures the total time the BiliBed has been in use. By monitoring this display, your phototherapist has accurate means of determining when the fluorescent tube should be changed (recommended: every 1500 hours).

Hour meters

The hour meter "h" shows the therapy time. Note Both displays will only light up when the BiliBed is plugged in. BiliBeds with model numbers 0380009 and 0380011 (Model numbers can be found on the bottom side of the BiliBed) These BiliBeds contain an LED-warning light. A phototransistor monitors the light emitted from the fluorescent tube in the range of approximately 425-475nm. If the emission falls below approximately 75% of the level of a new fluorescent tube, the red LED-warning light will come on. If the warning light stays on more than 45 minutes, the fluorescent tube should be changed for optimal therapeutic effect. Although the light continues to provide therapy, the BiliBed will operate at a reduced level of effectiveness.

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12. Caring for your baby during Phototherapy It is important to keep a written record of baby's number of bowel movements, wet diapers and feeding sessions during each day. Your phototherapist may provide you with a form to keep track of your baby’s activities.

12.1 Bowel movements After the third day of life, a baby in phototherapy may have more bowel movements than the usual 2 -5 per day. Baby's stools will be watery and a brownish, greenish color. This is due to the breakdown of the bilirubin. To prevent dehydration from the frequent bowel movements, your doctor or phototherapist may suggest feeding the baby more frequently.

12.2 Urination Your baby should have six or more wet diapers in each 24-hour period. After the third day of life the urine should be pale yellow. If your baby has not urinated in 8 hours, notify your physician. Determining when your baby has urinated can be a problem with the new, superdry disposable diapers. These diapers contain a chemical that changes urine into a gel that is difficult to see or feel. If you are using one of these diapers, try putting a clean handkerchief or paper towel between the diaper and the baby. It will show immediately when diaper is wet.

12.3 Breastfeeding Your baby needs to be nursed eight to twelve times in each 24 hour period, 10 - 15 minutes per breast. Elevated bilirubin levels can cause your baby to be sleepier than usual. Therefore, your baby needs to eat heartily to keep up the fluids in his/her body. Your breastmilk is all that baby needs to maintain his/her body fluids, as long as you nurse him/her often. The calories and protein in breastmilk coat the intestines and help prevent reabsorption of bilirubin into the blood stream. If your baby will not wake up to nurse, or if the baby nurses poorly, it is essential that you pump your breasts every 2 - 3 hours and feed the baby your breastmilk by other means. If you are concerned about the possibility of nipple confusion (some babies have trouble switching between breasts and bottles), you can feed your baby with a cup, medicine spoon, syringe or with Medela’s SoftFeeder or Disposable Baby Cup Feeder. It is, however, imperative that your baby receives plenty of liquid in his/her system, i.e. that the baby is fed eight to twelve times per day. If you have difficulty with this, contact your phototherapist, physician or lactation consultant. If your baby will not wake up to breastfeed or if the baby nurses poorly, pump each breast at least ten minutes, at least eight times daily, to keep up your milk supply. Hospital-grade electric breastpumps are very effective for maintaining milk supply and can be rented inexpensively. Ask your phototherapist or doctor for the name of a breastpump rental station or call 1-800-TELL-YOU.

12.4 Bottle feeding If you are not breastfeeding, continue feeding your baby the formula prescribed by your pediatrician. Your baby does not need any extra water unless it is ordered by the doctor. For problems, contact your doctor or phototherapist.

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12.5 Baby's temperature The baby’s temperature should be taken axillary (in the armpit) upon initiating treatment and then during a feeding, approximately every three hours. To take your baby’s temperature, place the thermometer in baby's armpit and keep his/her arm down against the side. Leave the thermometer in the armpit until the numbers stabilize, about 3-4 minutes.

If the temperature is below 97.4 degrees Fahrenheit or above 99.5 degrees Fahrenheit, take the temperature again rectally. Insert the thermometer about 1/4 inch into the baby's rectum after lubricating with petroleum jelly, and hold carefully for 2 to 3 minutes. If the temperature is still below 97.4 degrees or above 99.5 degrees, call your phototherapist or doctor.

12.6 Baby's skin No lotions or oils should be used on the baby while using the BiliBed7. It is normal for newborns to initially have dry, peeling skin. This will improve with time. Contact your phototherapist or doctor if the baby's skin worsens during phototherapy.

13. How long will the BiliBed be needed? When using the BiliBed, it may take a couple of days for your baby's bilirubin level to drop to acceptable levels. Continue to use the BiliBed for as long as your baby's doctor advises.

14. Warning Signs Contact your phototherapist or doctor: ¾ If the baby's temperature falls below 97.4 degrees or above 99.5 degrees (Fahrenheit). ¾ If your baby has fewer than two to five bowel movements in a 24 hour period. ¾ If your baby has not urinated in 8 hours, or if your baby does not have at least six or more wet diapers in each 24-hour period. ¾ If your baby has feeding problems. ¾ If your baby's skin becomes irritated, worsens, or red rashes appear during phototherapy.

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15. Cleaning the BiliBed7 15.1 Light unit and baby support cleaning ¾ Unplug the unit from the power supply. ¾ Wipe surfaces with a damp cloth. Cloth can be moistened with cleaning or disinfecting solutions, such as Medela’s Cavicide7. Important: Do not use cleaning solutions such as appliance disinfectants that use formaldehyde. Do not autoclave the baby support or disinfect by using heat.

15.2 BilicombiJ 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 Washable Bilicombi follow the cleaning instructions below: ¾ Remove Bilicombi from BiliBed ¾ Zip Bilicombi and attach under-chin Velcro7 fastener.

¾ Wash for Standard Machine cycle. Minimum wash cycle of 10 minutes is recommended. ¾ Machine wash in hot water. Minimum temperature 140 degrees F (60°C). ¾ Maximum temperature 210 degrees F (95°C) ¾ Use standard cleaning detergent. Refer to washing machine manufacturer for instructions. ¾ Use of Chlorine Bleach can cause color to bleed and/or fade and can reduce life of Bilicombi by 75%. ¾ Tumble dry low heat. ¾ If any of the Velcro fasteners show decreased adherence, a new Bilicombi should be used.

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16. Technical specifications for series 038 16.1 Light unit Power supply Power consumption Light tube Light tube life Irradiation

Dimensions: Length Width Height Weight

12V DC through power adapter 90-264V ~47-63Hz < 20W Compact fluorescent tube, Order no. 936.0015 Approx. 1,500 hours 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) 63 cm (24.8 inches) 32.6 cm (12.8 inches) 13 cm (5.1 inches), including baby support 4 kg (9 lbs)

16.2 Baby support Cover Weight

polyurethane (PUR) plastic 1.2 kg (2 lbs, 10 oz)

16.3 Complete device Total dimensions Operating conditions Storage conditions

65 x 35.4 x 13.4 cm (25.6 x 13.9 x 5.3 inches) + 5°C to + 30°C (+ 40°F to + 86°F) - 20°C to + 50°C (- 68°F to + 120°F)

16.4 Washable BilicombiJ Therapy Blanket Top material excluding trim White underside material

75% cotton, 25% polyester 100% cotton

16.5. Disposable Bilicombi Therapy Blanket Top material excluding trim White underside material

Parent's Guide

100% non-woven spun-laced fabric 100% cotton

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16.6 Key to symbols BiliBed7 Ensure that the patient is positioned correctly (see section 10). 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.

The BiliBed should not be used in an incubator On/Off switch for lamp Refer to instructions Model B unit

IPX4 Protection against splashing water Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only in accordance with UL 2601-1 22PL

Power adapter Direct current Protection class II

Must not be disposed of together with household refuse

For indoor use only

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17. Ordering references Article # 038.4002

Medela7 BiliBed7 with dual hour meters – for purchase consisting of a light unit, Start/Stop switch, a baby support with a plastic cover, instructions for use. 120 V/60 Hz, 1 each

038.4002R

Medela BiliBed with dual hour meters – for rental consisting of a light unit, Start/Stop switch, a baby support with a plastic cover, instructions for use. 230 V/60 Hz, 1 each

936.0015

Compact fluorescent tube, 1 each

800.0229 800.0336

BilicombiJ Washable therapy blanket, 1 each Bilicombi Disposable therapy blanket, 10 per case

808.0018

Plastic cover, 1 each

200.0100 190.0549 200.0076

Instructions for use, 1 each Parent’s Guide to Home Phototherapy, 1 each Service Manual, 1 each

190.7337

Baby’s Phototherapy Log, 100 each

800.0341

BiliBed Carrying Case

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Medela, Inc. P.O. Box 660, McHenry, IL 60051-0660 P.O. Box 131, Mississauga, Ontario, Canada L4T 3B5 Phone 800-435-8316 or 815-363-1166. Fax 815-363-1246 ©2007 Medela. Made in Switzerland. BiliBed and Medela are registered trademarks and Bilicombi is a trademark of Medela. Velcro is a registered trademark of Velcro Industries. Cavicide is a registered trademark of Micro. Aseptic Products, Inc.

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