BT-450 Operation manual
P/N:450-ENG-OPM-EXP-R01
Bistos Co., Ltd.
2021.06
3
Intended use/Indications for use
The infant phototherapy equipment, BT-450 is indicated for use to treatment of infants diagnosed with
hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the
skin and the whites of the eyes. The devices can be used in a hospital or at home.
The device is designed to use for patient population described in the infant, who is age up to 3 months and
weight less than 10kg.
Product Description
Jaundice refers to the yellow appearance of the skin that
occurs with the deposition of bilirubin in the dermal and
subcutaneous tissue. Bilirubin is the orange-yellow pigment
of bile, formed principally by the breakdown of hemoglobin
in red blood cells at the end of their normal lifespan.
Normally in the body, bilirubin is processed through the liver,
where it is conjugated to glucuronic acid by the enzyme in
the liver. This conjugated form of bilirubin is then excreted
into the bile and removed from the body via the gut. When
this excretion process is low following birth, does not work
efficiently, or is overwhelmed by the amount of
endogenously produced bilirubin, the amount of bilirubin in the body increases, resulting in
hyperbilirubinemia and jaundice.
In newborns, the lifespan of red blood cells is shorter than that of adults, which makes a lot of bilirubin, the
function of an enzyme to conjugate the bilirubin is poor, and the function to excrete bilirubin out of the
body is also weak.
Phototherapy refers to the use of light to convert unconjugated bilirubin molecules into water-soluble
isomers that can be excreted in bile or urine without the need for conjugation. Bilirubin absorbs light most
strongly in the blue region of the spectrum near 460 nm, a region in which penetration of tissue by light
increases markedly with increasing wavelength. Only wavelengths that penetrate tissue and are absorbed
by bilirubin have a phototherapeutic effect. Lamps with output predominantly in the 460-to-490-nm blue
region of the spectrum are probably the most effective for treating hyperbilirubinemia.
The infant phototherapy equipment, BT-450 pad consists of LEDs that emits light of peak wavelength 455
to 465 nm. The microcontroller generates the PWM, and it is rectified to direct current through a resistor
and a capacitor. When the rectified PWM is output through the LED driver, the LED can be stably turned on.
The intensity of light can be adjusted by changing the duty cycle of PWM, and BT-450 has two types of
intensity, high and low.
WARNING
Eye Protection: Do not look directly into the LED. During the treatment, always use
a patch or equipment to protect a baby’s eyes.
Periodically, check the hospital or treatment protocol and makes sure that the
baby’s eyes are protected from contamination.
Patients near the light should use protective pads or equipment to protect their
eyes.
Contraindications
It should not be used in cases of congenital porphyria, a family history of porphyria, and treatment with
photosensitive drugs or medicines.
