Bililight Packet V1.pdf


1. An*Introduction*to*Bililights:*(PowerPoint(

1. Operation*and*Use:*
a. Brief(Introduction(to(Phototherapy((p.(3)(
b. Brief(Introduction(to(Bilirubinometers((p.(4)(
c. Introduction(to(Neonatal(Jaundice((p.(5P12)(
d. Operation(and(Use(of(Phototherapy(Lights((p.(13P14)(

2. Diagrams*and*Schematics:*
a. Figure(1:((WHO(Specification(for(Bilirubinometer((p.16P18)(

3. Preventative*Maintenance*and*Safety:*
a. Bililight(Preventative(Maintenance((p.(20)*
b. Preventative(Maintenance(Table(for(Lights((p.(21)*

4. Troubleshooting*and*Repair:**
a. Bililight(Repair(and(Troubleshooting(Flowchart((p.(23P24)*
b. Lights(Troubleshooting(Table((p.(25)*

5. Resources*for*More*Information*
a. Resources(for(More(Information((p.(27)*
b. Bibliography((p.(28)*











* *



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© Copyright ECRI Institute 2012 (not including GMDN codes and device names).
UMDNS codes and devices names: © Copyright ECRI Institute 2012.

Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.
GMDN Codes and Term Names: © Copyright and database rights: GMDN Agency Ltd 2005-2012. All rights reserved.

Health problem addressed
Devices used to treat hyperbilirubinemia, characterized by high
bilirubin concentrations in the blood. Bilirubin, a product of
hemoglobin breakdown, remains in the body until the liver can
convert it to a form that can be excreted. Jaundice, a yellowish
discoloration of the skin, eyes, and mucous membranes, results
when bilirubin levels in the blood are too high. High bilirubin
levels can be caused by the inability of an immature liver to
process high levels of bilirubin, particularly in neonates.

Product description
Phototherapy units consist of a light source and a means of
allowing the light to radiate the infant. Devices using overhead
lamps can be freestanding on casters, ceiling or wall mounted,
or attached to infant radiant warmers or infant incubators;
some units have height and hood angle adjustments. Bassinet-
style units, in which the infant is placed in a plastic bassinet
containing a bank of lights in an overhead case, are also
available. Fiberoptic phototherapy pad systems use a tungsten-
halogen bulb in a metal case, a flexible fiberoptic cable, and a
light-emitting plastic pad. Filtered blue light is delivered from
the source through the fiberoptic cable and emitted from the
sides and ends of the fibers inside the pad, which is wrapped
around the infant.

Principles of operation
Visible light, specifically the blue-light wavelengths of
approximately 420 to 500 nanometers, photochemically
reduces bilirubin to water-soluble products that can be excreted.
The peak absorption wavelength at which bilirubin breaks down
is approximately 458 nm. By exposing patients to light of this
wavelength range, hyperbilirubinemia can be treated. Irradiance
level is controlled by light-intensity switches for both overhead
lamps and fiberoptic units and by the distance between the light
source and the patient. (Decreasing the distance between the
patient and the light source increases the irradiance level.) A
radiometer with an appropriate bandwidth is used to measure
the irradiance that reaches the patient during phototherapy.

Operating steps
• Eye mask is placed on unclothed infant and place infant in


• Depending on configuration, lamp distance is set depending
on intensity of therapy desired, or infant is wrapped in
fiberoptic pad.

• Treatment typically lasts 1-3 days.

Reported problems
Ultraviolet (280 to 400 nm) or near-infrared (780 to 1,400
nm) radiation must be filtered because at high enough levels,
both types of radiation can damage the eyes and skin. Known
common side effects of phototherapy include changes in body
temperature, insensible water loss, and diarrhea. With fiberoptic

units, a blanket can be wrapped around
the infant and fiberoptic pad to minimize
fluctuations in body temperature.

Use and maintenance
User(s): Nurse; clinician; medical staff

Maintenance: Biomedical engineering staff
and/or service contract with the manufacturer
or third-party organization

Training: Initial training by manufacturer;
operator’s manuals; user’s guide

Environment of use
Settings of use: Hospital; birthing center

Requirements: Line power

Product specifications
Approx. dimensions (mm): 1200 x 650 x 250
for overhead lamp type; 200 x 350 x 150 for
fiberoptic type

Approx. weight (kg): 36 for overhead lamp
type; 2 for fiberoptic type

Consumables: Light bulbs; disposable pad

Price range (USD): 400-7,600 (2,000 typical);
price covers all types and variations

Typical product life time: 10 years

Shelf life (consumables): NA

Types and variations
• Overhead lamps

• Fiberoptic blanket systems

Phototherapy units, hyperbilirubinemia
17515 Phototherapy units, visible light,


Blanket/pad infant phototherapy unit
Overhead infant phototherapy unit

Other common names:
Bilirubin lamps; fiberoptic phototherapy blankets; neonatal phototherapy units

WHO. “Phototherapy units, hyperbilirubinemia.”
From the page: “Hospital medical equipment: Data

Sheets 2012.” WHO. Retrieved from: http://


Brief Introduction to
© Copyright ECRI Institute 2011 (not including the GMDN code and device name).

Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.

© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.










n Health problem addressed

In healthy full-term neonates, bilirubin can rise to peak levels of
5 to 13 mg/dL between the second and fi fth days of life before
decreasing to normal levels between the fi fth and seventh days.
This produces jaundice, a yellowish discoloration of the skin, eyes,
and mucous membranes. Monitoring bilirubin concentration is
also important in children and in adults where elevated levels
may indicate a pre-hepatic, hepatic, or post-hepatic metabolic

Product description
These devices come in a variety of physical confi gurations. They
may be relatively small, single-purpose hand-held instruments
that are simple to operate and are designed to measure the
concentration of bilirubin in the blood. They are often located in
neonatal intensive care units for rapid on-site bilirubin analysis,
which is essential for determining a proper treatment method.
Bilirubinometers may also be confi gured as larger benchtop
analyzers or stand-alone units.

Principles of operation
Bilirubin concentrations are determined either by whole
blood or serum analysis using spectrophotometric methods
or by skin-refl ectance measurements. The three methods of
spectrophotometric analysis are the direct spectrophotometric
method, the Malloy-Evelyn method, and the Jendrassik-Grof

Operating steps
Blood samples are required for spectrophotometric analysis.
The analysis technique depends on both the type or types of
bilirubin being measured and the age of the patient (neonate
versus child or adult). Cutaneous bilirubinometers do not require
a blood sample. A light-emitting sensor is placed on the infant’s
skin (optimally on the forehead or sternum). The refl ected light
is split into two beams by a dichroic mirror, and wavelengths of
455 nm and 575 nm are measured by optical detectors.

Reported problems
Rapid changes in hydration (body water content) during
therapy can cause fl uctuations in blood bilirubin concentrations,
making assay results uncertain. Photo-oxidation (light-induced
breakdown) of bilirubin occurs if samples are exposed to light
for more than a few hours. Therefore, blood samples should be
protected from exposure to light.

Use and maintenance
User(s): Operator, medical staff

Maintenance: Medical staff; technician;
biomedical or clinical engineer

Training: Initial training by manufacturer and

Environment of use
Settings of use: Hospital; clinic

Requirements: Stable power source

Product specifi cations
Approx. dimensions (mm): 110 x 150 x 200

Approx. weight (kg): 3.4

Consumables: NA

Price range (USD): 3,100 - 7,000

Typical product life time (years): 6 to 8

Shelf life (consumables): NA

Types and variations
Benchtop; stand-alone; handheld


Bilirubinometers, Cutaneous


Cutaneous bilirubinometer

Other common names:
Analyzers, Bilirubin; Bilirubin Analyzers; Jaundice Meters; Indirect Bilirubinometers

Brief Introduction to Bilirubinometers

WHO. “Bilirubinometer.” From the publication: Core Medical Equipment. Geneva, Switzerland, 2011.

11/5/2015 Neonatal jaundice - Wikipedia, the free encyclopedia 1/8

Neonatal jaundice

Jaundice in newborn

Classification and external resources

Specialty Pediatrics

ICD-10 P58




ICD-9-CM 773 (,

774 (

DiseasesDB 8881 (

MedlinePlus 001559


eMedicine ped/1061 (

Patient UK Neonatal jaundice (


MeSH D007567 (


Neonatal jaundice
From Wikipedia, the free encyclopedia

Neonatal jaundice or Neonatal hyperbilirubinemia, or
Neonatal icterus (from the Greek word ἴκτερος),
attributive adjective: icteric, is a yellowing of the skin
and other tissues of a newborn infant. A bilirubin level of
more than 85 μmol/l (5 mg/dL) leads to a jaundiced
appearance in neonates whereas in adults a level of
34 μmol/l (2 mg/dL) is needed for this to occur. In
newborns, jaundice is detected by blanching the skin
with pressure applied by a finger so that it reveals

underlying skin and subcutaneous tissue.[1] Jaundiced
newborns have yellow discoloration of the white part of
the eye, and yellowing of the face, extending down onto
the chest.

Neonatal jaundice can make the newborn sleepy and
interfere with feeding. Extreme jaundice can cause
permanent brain damage from kernicterus.

In neonates, the yellow discoloration of the skin is first
noted in the face and as the bilirubin level rises proceeds

caudal to the trunk and then to the extremities.[2] This
condition is common in newborns affecting over half

(50–60%) of all babies in the first week of life.[3]

Infants whose palms and soles are yellow, have serum
bilirubin level over 255 μmol/l (15 mg/dL) (more serious
level). Studies have shown that trained examiners
assessment of levels of jaundice show moderate

agreement with icterometer bilirubin measurements.[2] In
infants, jaundice can be measured using invasive or non-
invasive methods.


1 Causes
1.1 Unconjugated
1.2 Conjugated (Direct)
1.3 Non-organic causes
1.4 Physiological jaundice

2 Diagnosis
3 Treatment

3.1 Phototherapy
3.2 Exchange transfusions

4 Complications
5 Guidelines
6 References
7 External links

Wikipedia. “Neonatal Jaundice.” Wikipedia. Retrieved from:

Brief Introduction to BilirubinometersBrief Introduction to Bil rubinometers

Introduction to Neonatal Jaundice

11/5/2015 Neonatal jaundice - Wikipedia, the free encyclopedia 2/8

In neonates, jaundice tends to develop because of two factors - the breakdown of fetal hemoglobin as it is replaced with adult
hemoglobin and the relatively immature metabolic pathways of the liver, which are unable to conjugate and so excrete bilirubin as
quickly as an adult. This causes an accumulation of bilirubin in the blood (hyperbilirubinemia), leading to the symptoms of

If the neonatal jaundice does not clear up with simple phototherapy, other causes such as biliary atresia, Progressive familial
intrahepatic cholestasis, bile duct paucity, Alagille syndrome, alpha 1-antitrypsin deficiency, and other pediatric liver diseases
should be considered. The evaluation for these will include blood work and a variety of diagnostic tests. Prolonged neonatal
jaundice is serious and should be followed up promptly.

Severe neonatal jaundice may indicate the presence of other conditions contributing to the elevated bilirubin levels, of which there
are a large variety of possibilities (see below). These should be detected or excluded as part of the differential diagnosis to prevent
the development of complications. They can be grouped into the following categories:




jaundice of

Hepatic Post-hepatic

Hemolytic Non-hemolytic





Intrinsic causes of hemolysis

Membrane conditions
Hereditary elliptocytosis

Systemic conditions
Arteriovenous malformation

Enzyme conditions
Glucose-6-phosphate dehydrogenase deficiency (also called G6PD deficiency)
Pyruvate kinase deficiency

Globin synthesis defect
sickle cell disease
Alpha-thalassemia, e.g. HbH disease

Extrinsic causes of hemolysis

Wikipedia. “Neonatal Jaundice.” Wikipedia. Retrieved from:

11/5/2015 Neonatal jaundice - Wikipedia, the free encyclopedia 3/8

Alloimmunity (The neonatal or cord blood gives a positive direct Coombs test and the maternal blood gives a positive
indirect Coombs test)

Hemolytic disease of the newborn (ABO)[1]

Rh disease[1]

Hemolytic disease of the newborn (anti-Kell)
Hemolytic disease of the newborn (anti-Rhc)
Other blood type mismatches causing hemolytic disease of the newborn

Non-hemolytic causes

Breast milk jaundice
Urinary tract infection
Gilbert's syndrome
Crigler-Najjar syndrome
High GI obstruction

Conjugated (Direct)

Liver causes

Hepatitis A
Hepatitis B
TORCH infections

Alpha-1-antitrypsin deficiency, which is commonly missed, and must be considered in DDx
Cystic fibrosis
Dubin-Johnson Syndrome
Rotor syndrome

Total parenteral nutrition


Biliary atresia or bile duct obstruction
Alagille syndrome
Choledochal cyst

Non-organic causes

Breastfeeding failure jaundice

"Breastfeeding failure jaundice" or "lack of breastfeeding jaundice," is caused by insufficient breast milk intake,[4] resulting in
inadequate quantities of bowel movements to remove bilirubin from the body. This can usually be ameliorated by frequent
breastfeeding sessions of sufficient duration to stimulate adequate milk production.

Breast milk jaundice

Whereas breast feeding jaundice is a mechanical problem, breast milk jaundice is a biochemical occurrence and the higher bilirubin
possibly acts as an antioxidant. Breast milk jaundice occurs later in the newborn period, with the bilirubin level usually peaking in

the sixth to 14th days of life. This late-onset jaundice may develop in up to one third of healthy breastfed infants.[5]

Wikipedia. “Neonatal Jaundice.” Wikipedia. Retrieved from:

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First, at birth, the gut is sterile, and normal gut flora takes time to establish. The bacteria in the adult gut convert conjugated
bilirubin to stercobilinogen which is then oxidized to stercobilin and excreted in the stool. In the absence of sufficient
bacteria, the bilirubin is de-conjugated by brush border β-glucuronidase and reabsorbed. This process of re-absorption is
called enterohepatic circulation. It has been suggested that bilirubin uptake in the gut (enterohepatic circulation) is increased
in breast fed babies, possibly as the result of increased levels of epidermal growth factor (EGF) in breast milk.[6] Breast milk
also contains glucoronidase which will increase deconjugation and enterohepatic recirculation of bilirubin.

Second, the breast-milk of some women contains a metabolite of progesterone called 3-alpha-20-beta pregnanediol. This
substance inhibits the action of the enzyme uridine diphosphoglucuronic acid (UDPGA) glucuronyl transferase responsible
for conjugation and subsequent excretion of bilirubin. In the newborn liver, activity of glucuronyl transferase is only at 0.1-
1% of adult levels, so conjugation of bilirubin is already reduced. Further inhibition of bilirubin conjugation leads to
increased levels of bilirubin in the blood.[7] However, these results have not been supported by subsequent studies.[8]

Third, an enzyme in breast milk called lipoprotein lipase produces increased concentration of nonesterified free fatty acids
that inhibit hepatic glucuronyl transferase, which again leads to decreased conjugation and subsequent excretion of

Physiological jaundice

Most infants develop visible jaundice due to elevation of unconjugated bilirubin concentration during their first week. This
common condition is called physiological jaundice. This pattern of hyperbilirubinemia has been classified into two functionally
distinct periods.

Phase one

1. Term infants - jaundice lasts for about 10 days with a rapid rise of serum bilirubin up to 204 μmol/l (12 mg/dL).
2. Preterm infants - jaundice lasts for about two weeks, with a rapid rise of serum bilirubin up to 255 μmol/l (15 mg/dL).

Phase two - bilirubin levels decline to about 34 μmol/l (2 mg/dL) for two weeks, eventually mimicking adult values.

1. Preterm infants - phase two can last more than one month.
2. Exclusively breastfed infants - phase two can last more than one month.

Mechanism involved in physiological jaundice are mainly:

Relatively low activity of the enzyme glucuronosyltransferase which normally converts unconjugated bilirubin to conjugated
bilirubin that can be excreted into the gastrointestinal tract.[10] Before birth, this enzyme is actively down-regulated, since
bilirubin needs to remain unconjugated in order to cross the placenta to avoid being accumulated in the fetus.[11] After birth,
it takes some time for this enzyme to gain function.
Shorter life span of fetal red blood cells,[10] being approximately 80 to 90 days in a full term infant,[12] compared to 100 to
120 days in adults.
Relatively low conversion of bilirubin to urobilinogen by the intestinal flora, resulting in relatively high absorption of
bilirubin back into the circulation.[10]


Clinical Assessment

This method is less accurate and more subjective in estimating jaundice.

Ingram icterometer: In this method a piece of transparent plastic known as Ingram icterometer is used. Ingram icterometer is
painted in five transverse strips of graded yellow lines. The instrument is pressed against the nose and the yellow colour of the
blanched skin is matched with the graded yellow lines and bilirubin level is assigned.

Transcutaneous bilirubinometer: This is hand held, portable and rechargeable but expensive and sophisticated. When pressure is
applied to the photoprobe, a xenon tube generates a strobe light, and this light passes through the subcutaneous tissue. The
reflected light returns through the second fiber optic bundle to the spectrophotometric module. The intensity of the yellow color in
this light, after correcting for the hemoglobin, is measured and instantly displayed in arbitrary units.

Wikipedia. “Neonatal Jaundice.” Wikipedia. Retrieved from:

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newborn infant undergoing (white light)
phototherapy to treat neonatal jaundice

Any of the following features characterizes pathological jaundice:

1. Clinical jaundice appearing in the first 24 hours or greater than 14 days of life.
2. Increases in the level of total bilirubin by more than 8.5 μmol/l (0.5 mg/dL) per hour or (85 μmol/l) 5 mg/dL per 24 hours.
3. Total bilirubin more than 331.5 μmol/l (19.5 mg/dL) (hyperbilirubinemia).
4. Direct bilirubin more than 34 μmol/l (2.0 mg/dL).

The aim of clinical assessment is to distinguish physiological from pathological jaundice. The signs which help to differentiate
pathological jaundice of neonates from physiological jaundice of neonates are the presence of intrauterine growth restriction,
stigma of intrauterine infections (e.g. cataracts, small head, and enlargement of the liver and spleen), cephalohematoma, bruising,
signs of bleeding in the brain's ventricles. History of illness is noteworthy. Family history of jaundice and anemia, family history of
neonatal or early infant death due to liver disease, maternal illness suggestive of viral infection (fever, rash or lymphadenopathy),
maternal drugs (e.g. sulphonamides, anti-malarials causing red blood cell destruction in G6PD deficiency) are suggestive of

pathological jaundice in neonates.[13]


The bilirubin levels for initiative of phototherapy varies depends on the age and health status of the newborn. However, any

newborn with a total serum bilirubin greater than 359 μmol/l ( 21 mg/dL) should receive phototherapy.[14]


The use of phototherapy was first discovered, accidentally, at Rochford Hospital in Essex, England. The ward sister (Charge
Nurse) of the premature baby unit firmly believed that the infants under her care benefited from fresh air and sunlight in the
courtyard. Although this led to the first noticing of jaundice being improved with sunlight, further studies only progressed when a
vial of blood sent for bilirubin measurement sat on a windowsill in the lab for several hours. The results indicated a much lower
level of bilirubin than expected based on the patient's visible jaundice. Further investigation led to the determination that blue light,
wavelength of 420-480nm (peak 458nm), oxidized the bilirubin to biliverdin, a soluble product that does not contribute to
kernicterus. Although some pediatricians began using phototherapy in the United Kingdom following Dr. Cremer's publishing the
above facts in the Lancet in 1958, most hospitals only began to regularly use phototherapy ten years later when an American group

independently made the same discovery.[15][16]

Infants with neonatal jaundice are treated with colored light called phototherapy.
Physicians randomly assigned 66 infants 35 weeks of gestation to receive
phototherapy. After 15±5 the levels of bilirubin, a yellowish bile pigment that in
excessive amounts causes jaundice, were decreased down to 0.27±0.25 mg/dl/h in
the blue light. This suggests that blue light therapy helps reduce high bilirubin

levels that cause neonatal jaundice.[17]

Exposing infants to high levels of colored light changes trans-bilirubin to the more
water-soluble cis-form which is excreted in the bile. Scientists studied 616
capillary blood samples from jaundiced newborn infants. These samples were
randomly divided into three groups. One group contained 133 samples and would
receive phototherapy with blue light. Another group contained 202 samples would
receive room light, or white light. The final group contained 215 samples, and
were left in a dark room. The total bilirubin levels were checked at 0, 2, 4, 6, 24,
and 48 hours. There was a significant decrease in bilirubin in the first group exposed to phototherapy after two hours, but no
change occurred in the white light and dark room group. After 6 hours, there was a significant change in bilirubin level in the white
light group but not the dark room group. It took 48 hours to record a change in the dark room group’s bilirubin level. Phototherapy

is the most effective way of breaking down a neonate’s bilirubin.[18]

Phototherapy works through a process of isomerization that changes trans-bilirubin into the water-soluble cis-bilirubin


In phototherapy, blue light is typically used because it is more effective at breaking down bilirubin (Amato, Inaebnit, 1991). Two
matched groups of newborn infants with jaundice were exposed to intensive green or blue light phototherapy. The efficiency of the
treatment was measured by the rate of decline of serum bilirubin, which in excessive amounts causes jaundice, concentration after

Wikipedia. “Neonatal Jaundice.” Wikipedia. Retrieved from:

11/5/2015 Neonatal jaundice - Wikipedia, the free encyclopedia 6/8

6, 12 and 24 hours of light exposure. A more rapid response was obtained using the blue lamps than the green lamps. However, a
shorter phototherapy recovery period was noticed in babies exposed to the green lamps(1). Green light is not commonly used
because exposure time must be longer to see dramatic results(1).

Ultraviolet light therapy may increase the risk of skin moles, in childhood. While an increased number of moles is related to an

increased risk of skin cancer,[21][22][23] it is not ultraviolet light that is used for treating neonatal jaundice. Rather, it is simply a
specific frequency of blue light that does not carry these risks.

Increased feedings help move bilirubin through the neonate’s metabolic system.[24]

The light can be applied with overhead lamps, which means that the baby's eyes need to be covered, or with a device called a
Biliblanket, which sits under the baby's clothing close to its skin.

Exchange transfusions

Much like with phototherapy the level at which exchange transfusion should occur depends on the health status and age of the

newborn. It should however be used for any newborn with a total serum bilirubin of greater than 428 μmol/l ( 25 mg/dL ).[14]


Prolonged hyperbilirubinemia (severe jaundice) can result into chronic bilirubin encephalopathy (kernicterus).[25][26] Quick and

accurate treatment of neonatal jaundice helps to reduce the risk of neonates developing kernicterus.[27]

Infants with kernicterus may have a fever[28] or seizures.[29] High pitched crying is an effect of kernicterus. Scientists used a
computer to record and measure cranial nerves 8, 9 and 12 in 50 infants who were divided into two groups equally depending upon

bilirubin concentrations. Of the 50 infants, 43 had tracings of high pitched crying.[30]

Exchange transfusions performed to lower high bilirubin levels are an aggressive treatment.[31]


American Academy of Pediatrics has issued guidelines for managing this disease, which can be obtained for free.[32]

National Institute for Health and Care Excellence (NICE) has issued guidelines for the recognition and treatment of neonatal

jaundice in the United Kingdom.[33]


1. Click, R; Dahl-Smith, J; Fowler, L; DuBose, J; Deneau-Saxton, M; Herbert, J (January 2013). "An osteopathic approach to reduction of
readmissions for neonatal jaundice". Osteopathic Family Physician 5 (1). doi:10.1016/j.osfp.2012.09.005.

2. Madlon-Kay, Diane J. Recognition of the Presence and Severity of Newborn Jaundice by Parents, Nurses, Physicians, and Icterometer
Pediatrics 1997 100: e3

3. "Neonatal Jaundice" (PDF). Intensive Care Nursery House Staff Manual. UCSF Children's Hospital. 2004. Retrieved 26 July 2011.
4. Lynn C. Garfunkel; Jeffrey; Cynthia Christy (2002). Mosby's pediatric clinical advisor: instant diagnosis and treatment. Elsevier Health

Sciences. pp. 200–. ISBN 978-0-323-01049-8. Retrieved 14 June 2010.
6. Kumral, A; Ozkan H; Duman N; et al. (2009). "Breast milk jaundice correlates with high levels of epidermal growth factor". Pediatr Res

66: 218–21. doi:10.1203/pdr.0b013e3181ac4a30.
7. Arias, IM; Gartner LM; Seifter S; Furman M (1964). "Prolonged neonatal unconjugated hyperbilirubinemia associated with breast feeding

and a steroid, pregnane-3(alpha), 20(beta)-diol in maternal milk that inhibits glucuronide formation in vitro.". J Clin Invest 43: 2037–47.

8. Murphy, J F; Hughes I; Verrier Jones ER; Gaskell S; Pike AW (1981). "Pregnanediols and breast-milk jaundice.". Arch Dis Child 56:
474–76. doi:10.1136/adc.56.6.474.

9. Poland, R L; Schultz GE; Gayatri G (1980). "High milk lipase activity associated with breastmilk jaundice.". Pediatr Res 14: 1328–31.

10. Page 45 ( in: Obstetrics & Gynaecology, by B. Jain,
2002. ISBN 8180562107, 9788180562105

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11. McDonagh, A. F. (2007). "Movement of Bilirubin and Bilirubin Conjugates Across the Placenta". Pediatrics 119 (5): 1032–1033; author
1033 1033. doi:10.1542/peds.2006-3669. PMID 17473108.

12. Harrison, K. L. (1979). "Fetal Erythrocyte Lifespan". Journal of Paediatrics and Child Health 15 (2): 96–97. doi:10.1111/j.1440-

13. Nadir S, Saleem F, Amin K, Mahmood K (2011). "Rational use of phototherapy in the treatment of physiologic jaundice neonatorum"
(PDF). Journal of Pharmaceutical Sciences and Research (Journal of Pharmaceutical Sciences and Research) 3 (1).

14. American Academy of Pediatrics Subcommittee on Hyperbilirubinemia (July 2004). "Management of hyperbilirubinemia in the newborn
infant 35 or more weeks of gestation". Pediatrics 114 (1): 297–316. doi:10.1542/peds.114.1.297. PMID 15231951.

15. Dobbs, R H; R J Cremer (November 1975). "Phototherapy.". Archives of Disease in Childhood 50 (11): 833–836.
doi:10.1136/adc.50.11.833. ISSN 0003-9888. PMC 1545706. PMID 1108807.

16. Cremer, R. J.; P. W. Perryman; D. H. Richards (1958-05-24). "INFLUENCE OF LIGHT ON THE HYPERBILIRUBINÆMIA OF
INFANTS". The Lancet 271 (7030): 1094–1097. doi:10.1016/S0140-6736(58)91849-X. ISSN 0140-6736. Retrieved 2010-08-01.

17. Amato M, Inaebnit D (February 1991). "Clinical usefulness of high intensity green light phototherapy in the treatment of neonatal
jaundice". Eur. J. Pediatr. 150 (4): 274–6. doi:10.1007/BF01955530. PMID 2029920.

18. Leung C, Soong WJ, Chen SJ (July 1992). "[Effect of light on total micro-bilirubin values in vitro]". Zhonghua Yi Xue Za Zhi (Taipei) (in
Chinese) 50 (1): 41–5. PMID 1326385.

19. Stokowski LA (December 2006). "Fundamentals of phototherapy for neonatal jaundice". Adv Neonatal Care 6 (6): 303–12.
doi:10.1016/j.adnc.2006.08.004. PMID 17208161.

20. Ennever JF, Sobel M, McDonagh AF, Speck WT (July 1984). "Phototherapy for neonatal jaundice: in vitro comparison of light sources".
Pediatr. Res. 18 (7): 667–70. doi:10.1203/00006450-198407000-00021. PMID 6540860.

21. Pullmann H, Theunissen A, Galosi A, Steigleder GK (November 1981). "[Effect of PUVA and SUP therapy on nevocellular nevi (author's
transl)]". Z. Hautkr. (in German) 56 (21): 1412–7. PMID 7314762.

22. Titus-Ernstoff L, Perry AE, Spencer SK, Gibson JJ, Cole BF, Ernstoff MS (August 2005). "Pigmentary characteristics and moles in
relation to melanoma risk". Int. J. Cancer 116 (1): 144–9. doi:10.1002/ijc.21001. PMID 15761869.

23. Randi G, Naldi L, Gallus S, Di Landro A, La Vecchia C (September 2006). "Number of nevi at a specific anatomical site and its relation to
cutaneous malignant melanoma". J. Invest. Dermatol. 126 (9): 2106–10. doi:10.1038/sj.jid.5700334. PMID 16645584.

24. Wood, S. (2007, March). Fact or fable?. Baby Talk, 72(2).
25. Juetschke, L.J. (2005, Mar/Apr). Kernicterus: still a concern. Neonatal Network, 24(2), 7-19, 59-62
26. Colletti, JE; Kothari, S; Kothori, S; Jackson, DM; Kilgore, KP; Barringer, K (November 2007). "An emergency medicine approach to

neonatal hyperbilirubinemia". Emerg. Med. Clin. North Am. 25 (4): 1117–35, vii. doi:10.1016/j.emc.2007.07.007. PMID 17950138.
27. Watchko, JF (December 2006). "Hyperbilirubinemia and bilirubin toxicity in the late preterm infant". Clin Perinatol 33 (4): 839–52;

abstract ix. doi:10.1016/j.clp.2006.09.002. PMID 17148008.
28. Shah, Z; Chawla, A; Patkar, D; Pungaonkar, S (March 2003). "MRI in kernicterus". Australas Radiol 47 (1): 55–7. doi:10.1046/j.1440-

1673.2003.00973.x. PMID 12581055.
29. Malik, BA; Butt, MA; Shamoon, M; Tehseen, Z; Fatima, A; Hashmat, N (December 2005). "Seizures etiology in the newborn period".

Journal of the College of Physicians and Surgeons--Pakistan 15 (12): 786–90. PMID 16398972.
30. Vohr, BR; Lester, B; Rapisardi, G (August 1989). "Abnormal brain-stem function (brain-stem auditory evoked response) correlates with

acoustic cry features in term infants with hyperbilirubinemia". J. Pediatr. 115 (2): 303–8. doi:10.1016/S0022-3476(89)80090-3.
PMID 2754560.

31. Gómez, M; Bielza, C; Fernández del Pozo, JA; Ríos-Insua, S (2007). "A graphical decision-theoretic model for neonatal jaundice". Med
Decis Making 27 (3): 250–65. doi:10.1177/0272989X07300605. PMID 17545496.

32. American Academy of Pediatrics. "AAP Issues New Guidelines for Identifying and Managing Newborn Jaundice". Retrieved 4 July 2009.
33. "Neonatal jaundice (CG98)". Retrieved 23 May 2013.

External links

Neonatal Hyperbilirubinemia Management and Learning Tool for Healthcare Providers
Jaundice in the first two weeks of life (
BiliTool - Hyperbilirubinemia Risk Assessment for Newborns (
Children's Liver Disease Foundation - information on jaundice in babies (
Neonatal jaundice ( - Southern Illinois University School of Medicine
Neonatal Jaundice ( at (
Using LED to cure Neonatal Jaundice ( at Medicaid Phototherapy Unit

Retrieved from ""

Categories: Neonatology Hepatology Haemorrhagic and haematological disorders of fetus and newborn

This page was last modified on 28 October 2015, at 11:01.

Wikipedia. “Neonatal Jaundice.” Wikipedia. Retrieved from:

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Equipment found in the OR, ICU and ER

2.12 Phototherapy lights

2.12.1 Clinical Use and Principles of Operation
The buildup of bilirubin in an infant’s blood, caused by decreased liver functions, can cause long
term damage to the child. Bilirubin buildup causes the patients’ coloring to range from yellow to
orange to red depending upon the level of bilirubin in the system. By exposing the patient to
light with wavelengths between 425 and 475 nm, the bilirubin is broken down, and then
eventually excreted from the body.

The phototherapy unit, or bili-lights, as they are more commonly called, is simply a strong source
of light in the correct wavelength. The baby sits in a basinet below the lights for 20 minutes or
more, depending on what the physician prescribes (see figure). The light is strong enough that it
can damage the retina. So, the patients’ eyes must be protected from the light when using the

Phototherapy lights are common in the developing world. However, the bulbs are often broken
or ineffective. Exam lights are often included as well as heating (IR) lamps.

2.12.2 Common Problems
The most common problem is a broken or missing light bulb. There is little else that can go
wrong. There are many substitute light sources. The use of Florissant brand tubes or Daylight
blue bulbs is quite common. The “Gro-Lux” light, also used by indoor gardeners was the most
common form of treatment. Unfortunately the Gro-Lux tubes degrade and have to be replaced
after about 200 hours of use to keep the light in the proper wavelength range. The same light
spectrum is used in a PUMA unit to treat certain skin disorders in adults. The light bulbs in
tanning beds are also in the correct wavelength range.

Malkin, Robert. “Phototherapy Lights.” Medical Instrumentation in the Developing World. Engineering World Health, 2006.

Operation and Use of Phototherapy Lights

Medical Instruments in the Developing World Malkin

2.12.3 Suggested Minimal Testing
If the light turns on and is still in the correct wavelength range, then the unit can be used. To verify
that the light is in the correct range, you need a light meter and a filter. A photographer’s light meter
can be used if the proper filter is at hand. If you have time, you can check the light source by leaving
your arm exposed to the light for 30 minutes. The next day, that part of your skin should be tan, but
not burned.

If you have replaced the light bulb, or have built a phototherapy unit from light bulbs that you
purchased (gro-lux or tanning bed lights, for example), then you must be sure that the lights are not
too intense for the patient. Again the ideal test is a light meter and a proper filter. However, you can
use the arm-tanning test mentioned above. Start with 5 minutes to be sure that you do not get
burned. Test longer and longer intervals until you can withstand 30 minutes without burning, but
receiving a significant tan. Explain your testing to the staff so that they know that it is safe for up to
30 minutes, but that you haven’t tested it for longer exposures.

If the light is working and you have a meter, you can also check that the intensity is consistent over
the entire surface of the patient.

Malkin, Robert. “Phototherapy Lights.” Medical Instrumentation in the Developing World. Engineering World Health, 2006.




* *

11/4/15 WHO_TS_61_MDs_web.xlsx 03

Page 1

i Version No. 1
ii Date of initial version 6/13/12
iii Date of last modification 6/18/14
iv Date of publication
v Completed / submitted by WHO working group

1 WHO Category / Code (under development)
2 Generic name Bilirubinometer

3 Specific type or variation (optional)

4 GMDN name Bilirubinometer IVD
5 GMDN code 47988
6 GMDN category 06 In vitro diagnostic devices
7 UMDNS name Bilirubinometers
8 UMDNS code 15109
9 UNSPS code (optional)

10 Alternative name/s (optional) Bilirubin analyser; Jaundice meter; Meter, jaundice

11 Alternative code/s (optional) S 15109; S 43856; S 44219
12 Keywords (optional) Bilirubin, Jaundice, Analyzer

13 GMDN/UMDNS definition (optional)

A mains electricity (AC-powered) laboratory instrument designed to determine, by
direct or indirect measurement, the concentration of bilirubin in the blood or other
clinical specimen most commonly to rapidly assess hyperbilirubinemia in neonates. It
typically performs the measurement using spectrophotometry or haemofluorometry.


Clinical or other purpose Determining the concentration of bilirubin in the blood or other clinical specimen,
most commonly to rapidly assess hyperbilirubinemia in neonates. (Bilirubin, a
product of haemoglobin breakdown, remains in the body until the liver can convert it
to a form that can be excreted. Jaundice, a yellowish discoloration of the skin, eyes,
and mucous membranes, is a major symptom noticed when bilirubin levels rise
above 5 mg/dl).

15 Level of use (if relevant) Health Centre, District Hospital, Provincial Hospital and Specialized Hospital

16 Clinical department/ward(if relevant) Obstetrics / Neonatal care / Neonatal Intensive Care Unit (NICU) / Laboratory

17 Overview of functional requirements

1. Measures bilirubin concentration in a blood sample.
2. Displays and prints total bilirubin concentration (conjugated bilirubin level is

18 Detailed requirements

1. Total bilirubin concentration measurable (at least) in range of 0 to 30 mg/dl.
2. Time for total concentration measurement: ≤ 5 seconds.
3. Sample volume of < 100 µl required, automatic calibration facility, either integral
printer for readings or interface with external printer. 4. Able to
perform at least 300 measurements with fully charged battery.
5. Measurement unit: mg/dL or µmol/L (user selectable).
6. Measuring range of at least 0.0 to 25 mg/dl or 0 to 425 µmol/lt.
7. Accuracy ± 1.5 mg/dl or ± 25.5 µmol/lt or better.
8. Not need any disposable or consumable to operate.
9. Light source life of 150K measurements or more.

19 Displayed parameters Backlit display with easy viewing in all ambient light levels. Electronic and printed readout.

(Including information on the following where relevant/appropriate, but not limited to)




WHO. “Bilirubinometer.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://

Figure 1: WHO Specification: Bilirubinometer

11/4/15 WHO_TS_61_MDs_web.xlsx 03

Page 2

20 User adjustable settings

21 Components(if relevant) N/A

22 Mobility, portability(if relevant)
Easy and safe transport to be possible by hand, stable when table-top mounted.
Hand held compact, lightweight, easy to use.

23 Raw Materials(if relevant) N/A


Electrical, water and/or gas
supply (if relevant)

1. Voltage corrector / stabilizer to allow operation at ± 30% of local rated voltage.
2. Electrical protection by resettable overcurrent breakers or replaceable fuses fitted
in both live and neutral lines.
3. Resettable overcurrent mains fuse to be incorporated.
4. Mains cable to be at least 3 m in length. 5.
Rechargeable battery operated.
6. Battery charger characteristics: Amperage: ______; Voltage: ______. 7.
Capable of operating continuously in ambient temperature of 10 to 40°C, and relative
humidity of RH: 30% to 95%.
[ Bilirubinometers must use a constant supply of electricity to operate, so energy
efficiency should be one of the main considerations when choosing an
environmentally preferred system. Some suppliers offer light-emitting diode (LED)
displays with their systems, which use less energy than liquid crystal displays
(LCDs) ].

25 Accessories (if relevant) Hard and splash-proof case to be supplied

26 Sterilization process for accessories (if relevant)
The case is to be cleanable with alcohol or chlorine wipes

27 Consumables / reagents (if relevant)
Disposable Cuvettes

28 Spare parts (if relevant)
Two sets of spare/replaceable fuses and/or batteries, five replacement rolls of printer
paper, reagents and capillary tubes sufficient for 100 tests. Spare light source.

29 Other components (if relevant)
Capillary tubes, haemofluorometric reagents (e.g., aqueous cyanide salt with
stabilizers, if applicable).

30 Sterility status on delivery (if relevant)

31 Shelf life (if relevant) N/A

32 Transportation and storage (if relevant)

33 Labelling (if relevant) N/A



1. Capable of being stored continuously in ambient temperature of 0 to 50 deg C
and relative humidity of 15 to 90%.
2. Capable of operating continuously in ambient temperature of 10 to 40 deg C and
relative humidity of 15 to 90%.

35 Pre-installation requirements(if relevant)
Supplier to perform installation, safety and operation checks before handover.

36 Requirements for commissioning (if relevant)

37 Training of user/s (if relevant)
Training of users in operation and basic maintenance shall be provided

38 User care(if relevant)

39 Warranty Two year warranty should be provided by the supplier.
40 Maintenance tasks Advanced maintenance tasks required shall be documented.
41 Type of service contract N/A








WHO. “Bilirubinometer.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://

11/4/15 WHO_TS_61_MDs_web.xlsx 03

Page 3

42 Spare parts availability post-warranty

43 Software / Hardware upgrade availability

44 Documentation requirements

1. User, technical and maintenance manuals to be supplied in (**** language).
2. List to be provided of equipment and procedures required for local calibration and
routine maintenance.
3. List to be provided of important spares and accessories with their part numbers
and cost.

45 Estimated Life Span 8 years

46 Risk Classification Class A (GHTF Rule 4); Class II (USA); Class I (EU, Japan, Canada and Australia)

47 Regulatory Approval / Certification
FDA approval (USA); CE mark (EU)


International standards ISO 13485:2003 Medical devices -- Quality management systems -- Requirements
for regulatory purposes (Australia, Canada and EU).
ISO 14971:2007 Medical devices -- Application of risk management to medical
IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance.
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements
for safety - Collateral standard: Safety requirements for medical electrical systems.
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests.

49 Reginal / Local Standards N/A


Regulations US regulations
21 CFR part 820
21CFR section 862.11106 diazo colorimetry, bilirubin
EU regulations
Council Directive 93/42/EEC
Directive 93/68/EEC (CE Marking)
Directive 98/79/EC
Directive 2001/104/EC
Directive 2007/47/EC
Japan regulations
MHLW Ordinance No.169 (Japan)
35475000 Bilirubinometry analyser (Japan)




WHO. “Bilirubinometer.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://











1. Check)for)signs)of)physical)damage)or)abuse) )
2. Check)for)evidence)of)fluid)spills) )
3. Check)AC)plug/cord/receptacle) )
4. Check)strain)relief)at)both)ends)of)cord) )
5. Check)controls/switches) )
6. Check)powerJon)sequence) )
7. Check)for)unusual)noise)or)vibration) )
8. Clean)interior/exterior)as)required) )
9. Test)all)audible)&)visual)alarms)and)indicators) )
10. Measure)chassis)ground)resistance) )
11. Measure)chassis)leakage)current) )
12. ))Clean)air)filter)
13. ))Electrical)safety)
14. ))Measure)light)output


Bililight Preventative Maintenance

Cooper, Justin and Alex Dahinten for EWH. “Bililight Preventative Maintenance.” From the publication: Medical Equipment Troubleshooting
Flowchart Handbook. Durham, NC: Engineering World Health, 2013.

User Care of Medical Equipment – First line maintenance for end users


User Care Checklist – Lamps



9 Wipe dust off exterior and cover equipment after checks

Visual checks

9 Check all fittings and accessories are mounted correctly

9 Check there are no cracks in glass / covers or liquid spillages


9 If in use that day, run a brief function check before clinic



9 Unplug, clean outside with damp cloth and dry off

9 Clean any filters, covers and battery compartment

9 Remove dirt from wheels/any moving part

Visual checks

9 Check all screws and parts are fitted tightly

9 Check mains plug screws are tight

9 Check mains cable has no bare wire and is not damaged


9 Check all switches operate correctly

9 Remove or charge batteries if out of use

Every six months
Biomedical Technician check required

Preventative Maintenance Table for Lights

Strengthening Specialised Clinical Services in the Pacific. User Care of Medical Equipment: A first line
maintenance guide for end users. (2015).










#. Text.Box. Explanation.or.Comment.
1" Begin:"Bililight" Start"the"diagnostic"process"for"a"work"order"on"a"bililight."

2" Does"device"power"on?" Displays,"lights,"and"sounds"are"all"indicators"that"the"device"has"turned"on."

3" Troubleshoot"power"supply"(separate"flowchart)." Most"bililights"have"an"ACGDC"power"supply."

4" Change"battery"if"necessary." Some"bililights"may"have"a"batterty."
5" Do"lights"come"on?" Do"the"blue"lights"illuminate"when"they"are"switched"on?"
6" Does"power"reach"bulb?" Does"the"appropriate"voltage"reach"the"input"for"the"bulb?"

7" Revise"intensity"control"knob." Make"sure"any"intensity"control"knob"is"turned"up"to"allow"the"lights"to"illuminate."

8" Check"for"bad"switches"and"knobs." Review"switches"and"potentiometers"for"faults."

9" Check"for"bad"connections"and"open"circuits"

Cooper, Justin and Alex Dahinten for EWH. “Bililightt Troubleshooting Flowchart.” From the publication: Medical Equipment Troubleshooting
Flowchart Handbook. Durham, NC: Engineering World Health, 2013.

Bililight Troubleshooting Flowchart



11" Replace"bulbs." If"the"appropriate"voltage"reaches"the"bulbs"and"they"do"not"illuminate,"the"bulbs"must"be"replaced."

12" Is"light"intensity">"4μW/cm2/nm"

13" Reposition"light"source." If"the"intensity"is"too"low,"the"light"source"may"be"position"too"far"from"the"patient."

14" Revise"intensity"control"knob." The"light"intensity"might"be"increased"by"manipulating"the"intensity"control"knob."

15" Clean"interior"of"machine." If"the"interior"of"the"machine"or"the"bulbs"are"dirty,"it"might"obstruct"the"light"source"or"cause"overheating"of"the"device."

16" Go"to"begin." Start"the"diagnostic"process"again"to"see"if"the"corrective"measures"have"solved"the"problem."

17" Bililight"is"working"properly." The"light"intensity"is"above"the"minimum,"and"the"device"can"be"used"with"patients."


Cooper, Justin and Alex Dahinten for EWH. “Bililightt Troubleshooting Flowchart.” From the publication: Medical Equipment Troubleshooting
Flowchart Handbook. Durham, NC: Engineering World Health, 2013.

User Care of Medical Equipment – First line maintenance for end users


Troubleshooting – Lamps

Fault Possible Cause Solution


No light or „power on‟ visible

No power at mains socket

Dead battery

Blown bulb

Battery leakage

Electrical cable fault

Internal wiring fault

Check power switch is on.
Replace fuse with correct rating
of voltage and current if blown.
Check mains power is present at
socket using equipment known to
be working. Contact electrician
for rewiring if power not present.

Charge or replace batteries

Replace bulb with correct voltage
and wattage

Remove batteries (if accessible),
clean battery terminals and
replace with new battery

Try cable on another piece of
equipment. Contact electrician
for repair if required.

Refer to electrician


Fuse / bulb keeps blowing

Fuse or bulb is wrong rating

Power supply or cable fault

Replace with correct rating

Refer to electrician


Light cannot be made bright

Dirt on lens or tube

Poor power supply

Wrong bulb rating

Control malfunction

Clean area with dry, clean cotton

Check power line or replace

Check bulb rating is correct

Refer to electrician


Electrical shocks

Wiring fault

Refer to electrician

Lights Troubleshooting Table

Strengthening Specialised Clinical Services in the Pacific. User Care of Medical Equipment: A first line
maintenance guide for end users. (2015).











1. Wikibooks(Contributors.(“17(Pregnancy(and(Birth.”(Human&Physiology.(Wikibooks,(2006.(See(

















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