BT-400

Neonatal Phototherapy

OPERATOR MANUAL

BT-400

P/N : OPM(BT-400)EN, Rev.03

BT-400 Operator Manual 1

Contents
1. Safety Information ------------------- 2
1.1 Explanation of Terminology---------------- 2
1.2 General Safety Information----------------- 2
1.3 Safety Symbols ----------------------- 3
2. Product Description ------------------- 4
2.1 Intended Use ------------------------ 4
2.2 Physical Characteristics ------------------ 4
2.3 Light Source (Main Body)----------------- 4
3. Components and User Controls ------------ 6
3.1 Components ------------------------ 6
3.2 Exterior and Name --------------------- 7
3.2 Power Assembly ---------------------- 8
4. Assembly and Operating Instructions---------- 9
4.1 Assembly -------------------------- 9
4.2 Operating Instructions ------------------- 9
5. Troubleshooting Guide----------------------- 11
6. Routine Cleaning and Maintenance----------- 12
6.1 Checking the Light Intensity---------------------- 12

6.2 Cleaning------------------------------------- 12

7. Specifications--------------------- 13

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 2

1. Safety Information
1.1 Explanation of Terminology

Warning!
Identifies conditions or practices that might present danger or possible injury
to the patient and/or user.

Caution!
An instruction that, if not followed, can result in a condition that could damage
the light.

Note
Background information provided to clarify a particular step or procedure.

1.2 General Safety Information

Before administering phototherapy, read all section of this manual carefully.

Observe all precautions to ensure the safety of the patient and those near the
instrument.

Warning!
Incorrect use of the light, or the use of parts and accessories that are not
manufactured of supplied by Bistos co., ltd can damage the light, and may
cause injury to the patient and/or user.

Warning! Attachment of the light source

When attaching light to any floor stand, other than Bistos Roll Stand, confirm
weight capacity of stand.

Warning!
Eye protection: Do not look directly into the LEDs. During treatment, always
protect the baby’s eye with patches or equivalent. Periodically and/or per your
hospital protocol, verify that the baby’s eyes are protected and free of
infection. Patients adjacent to the light may also need to be protected with
eye patches or equivalent.

Warning!
Operator Safety: Sensitive individuals may experience headache, nausea or
mild vertigo if he/she stays too long in the irradiated area. Wearing glasses
with yellow lenses can alleviate potential effects.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 3

Warning!
Photoisomers: Bilirubin Photoisomers may cause toxic effects.

Warning!
Photosensitive Drugs: The light generated can degrade photosensitive
medications. Do not place or store any drugs near or in the illuminated area.

Warning!
Combustion gases: Do not use the light in the presence of gases that support
combustion (for example, oxygen, nitrous oxide, or other anesthetic agents).

Warning!
Disconnect electrical power: Always switch off the power and disconnect the
power cord when cleaning the light.

1.3 Safety Symbols

Warning!
Be aware of the following systems, which appear on the light and/or Roll
Stand.

Symbol Meaning
Type B rated patient-applied parts

Power On

Power Off

Attention, consult product documentation

Always protect the baby’s eyes with eye patches or

equivalent

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 4

2. Product Description
BT-400 Phototherapy system consists of two products – Phototherapy light
source (Main Body) and the Roll stand.

2.1 Intended Use

BT-400 Phototherapy light is intended for the treatment of neonatal

hyperbilirubinemia.
The light can be used for infants in a bassinet, incubator, open bed, or radiant
warmer.

Note
Before use, read all of this manual carefully. There are safety considerations
that should be read and understood before use.

2.2 Physical Characteristics

BT-400 Phototherapy system is a floor-standing, mobile phototherapy light

that delivers a narrow band of high-intensity blue light via blue light emitting
diodes(LEDs) to provide treatment for neonatal hyperbilirubinemia.

2.3 Light Source (Main Body)

The light consists of a lightweight plastic light enclose and power assembly.
When used with the Roll Stand the light can be adjusted both horizontally and
vertically on the roll stand assembly.
The Phototherapy light can be used independently of the Roll Stand. In this
case, joint assembly can be use to fix the light source.
Blue LEDs emit light in the range of 400 – 550 nm (peak wavelength 450 –
475 nm).
This range corresponds to the spectral absorption of light by bilirubin, and is
thus considered to be the most effective for the degradation of bilirubin.
Blue LEDs do not emit significant energy in the ultraviolet (UV) range of
spectrum, so there is no concern about UV exposure to infant.
In addition, Blue LEDs do not emit significant energy in the infrared (IR) range
of spectrum, so there is no concern about IR exposure and excessive
warming of the infant.
As with all phototherapy lights, protective eyeshades must be used to protect
the infant’s eyes from excessive light exposure.

Warning!
Eye protection: Do not look directly into the LEDs. During treatment, always
protect the baby’s eye with patches or equivalent. Periodically and/or per your

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 5

hospital protocol, verify that the baby’s eyes are protected and free of
infection. Patients adjacent to the light may also need to be protected with
eye patches or equivalent.

LEDs have minimal light output degradation over their lifetime with proper use.
The light is expected to operate as specified approximately 20,000 hours.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 6

3. Components and User Controls

3.1 Components

Main Body Roll Stand(Optional)

Power Cord Operator Manual

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 7

3.2 Exterior and Name

The BT-400 phototherapy system includes the components shown in the

following figure.

Fig1. Main body and Roll Stand

① Light Source: The light can be adjusted both horizontally and vertically on
the roll stand assembly to desiring angle.
To remove the light from the roll stand, loosen the knob and lift the light
source assembly up and away from the roll stand.
② Adjustable Neck
③ Control Box (Power Assembly): It contains power switch and two LCD
displays. One shows operating hours, the other shows total operating time
(life time).
④ Height Adjustment Knob: The knob allows you to adjust the height of the
light source. First loosen the knob, then adjust the height of the light, and
finally tighten the knob to lock the height.
⑤ Roll Stand (Optional)

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 8

3.3 Power Assembly

The following figure shows the power assembly.

Operating Hours

< Power Switch >

Total Operating Time

< Power Socket >

Fig2. Power Assembly

Power Switch: Use this switch to turn the main power ON or OFF.
Operating hours display LCD: shows the each operating hours from the power
on to off.
The display format is shown below;

00000(hours).00(minutes)

Life time display LCD: shows the accumulated operating time since the first
power on.
The display format is shown below;

0000000(hours)

The time is saved in minute.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 9

4. Assembly and Operating Instructions

4.1 Assembly

The System consists of two products shipped in two separate boxes. One box
contains the light source assembly and the other box contains the Roll Stand.
To assemble the light, follow these steps:
1. Unpack the shipping boxes. Check contents against the packing lists.

2. Refer to assembly instructions enclosed in the Roll Stand.

4.2 Operating Instructions

1. Check Intensity: Before use, check the intensity of the light using a
spectrophotometer. The light provides the range of intensity from 45
2 2
㎼/㎝ /㎚ to 85 ㎼/㎝ /㎚ at 40㎝(16 inches) distance from the baby.

2. Prepare infant: Infant may lie in an open crib, a bassinet, an

incubator, or under a radiant warmer.

3. Shield infant’s eye with protective eye shields designed for use
during phototherapy.

Warning!
Eye protection: Do not look directly into the LEDs. During treatment, always
protect the baby’s eye with patches or equivalent. Periodically and/or per your
hospital protocol, verify that the baby’s eyes are protected and free of
infection. Patients adjacent to the light may also need to be protected with
eye patches or equivalent.

4. Position light over infant. Position the face of the light source no
closer to the infant than 40 ㎝(16 inches).

5. Switch on power, using the power switch at the power box.

6. Monitoring the patient during treatment.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 10

Warning!
Regular monitoring during treatment is recommended. Use the following
guidelines:
- Measure the patient’s bilirubin level periodically during
treatment.
- Turn off the light when checking the baby’s condition and
visualizing skin color.

- Verify that baby’s eyes are protected and free of infection.

7. When finished, switch power off and remove light from the therapy
area.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 11

5. Troubleshooting Guide

Warning!
Disconnect power cord before opening the light for repair.

Problem Possible Cause Action

The unit does - No power Verify that unit is plugged in.
not turn on - Defective switch Have a qualified technician
- Defective power check the components and
supply replace as necessary.

Some LEDs are One LED may have Have a qualified technician test
not lit burned out causing 3 or the intensity level and readjust
4 LEDs to go off. the intensity potentiometers to
achieve the desired output, if
required.

※ It is recommended that the intensity of the light should be check after

changing some LED.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 12

6. Routine Cleaning and Maintenance

6.1 Checking the Light Intensity

It is recommended that the intensity of the light be checked every 1,000 hours
use. Also, we recommend that you should change LED lamps after using
20,000 hours.

Have a qualified technician test the intensity level and readjust the intensity
potentiometers to achieve the desired output, if required.

Caution!
Only qualified personnel should perform service and repair, than the light
should be readjusted.

6.2 Cleaning

Warning!
Disconnect light from AC power before cleaning.

Remove dust from the exterior of the light with a soft brush of soft cloth
dampened with water. Sponge away remaining debris with a mild solution of
detergent and water, a noncaustic commercial cleaner, or hospital disinfectant.

Caution!
Observe the following precautions;
- Do not spray liquids directly onto the light, or allow them to seep into
the interior.
- Do not use caustic or abrasive cleaners.
- Do not clean with alcohol, acetone, or other solvents.
- Never immerse the light or its components parts.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 13

7. Specifications

Light Source Blue LEDs

- Wavelength Peak between 450 – 475 nm
2
45 ~ 85 ㎼/㎝ /㎚ at 40 ㎝(16
- Intensity
inches) distance
- Variation in intensity over 6 hours ± 10 % (within illumination area)
- Effective surface area 40 x 20 ㎝
- Heat output
< 10 ℃ warmer than ambient
(at 40 ㎝ over 6 hours)
Electrical Mains 100 – 240 Vac, 50 – 60 ㎐, 50VA
Safety
- Leakage current < 100 ㎂
- Audible Noise < 60 dB
Dimension
- Maximum height 170 ㎝
- Header 340 x 210 x 75 mm
Weight
- Light Assembly About 5 kg
- Roll Stand About 5.5 kg
Environmental
- Operating Temperature / Humidity 10 ~ 40 ℃ / 30 ~ 75 %
- Storage Temperature / Humidity -40 ~ 70 ℃ / 10 ~ 100 %
Type B
Regulatory Standards EN60601-1, EN60601-1-2
EN60601-2-50

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 14

Product Guarantee

Product Name Fetal Monitors

Model Name BT-400
Approval No.
Approval Date
Serial No.
Warranty Period 2 Years
Date of Purchase
Hospital:
Address:
Customer
Name:
Telephone:
Sales Agency

Manufacture Bistos Co., Ltd

※ Thank you for purchasing BT-400.

※ This product is manufactured and passed through strict

quality control and inspection.

※ Compensation standard concerning repair, replacement,

refund of the product complies with “Consumer’s protection
law” noticed by Economic Planning Dept.

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)

BT-400 Operator Manual 15

Service Telephone and Fax. Numbers

Telephone: +82 31 750 0340

Fax: +82 31 750 0344

Bistos Co., Ltd.

7th Fl., A Bldg., Woolim Lions Valley 5-cha, 144-3,
Sangdaewon-dong, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Korea

www.bistos.co.kr
bistos@bistos.co.kr

Model Name: BT-400

EC Representative: Medical Econet Gmbh

Im Erlengrund 20 / D-46149 Oberhausen / Germany

Telephone: +49 (0)208 377 890-0

Fax: +49 (0)208 377 890 55

P/N : OPM(BT-400)EN www.bistos.co.kr Rev. 03 (2013.04.12)