BT-400
Neonatal Phototherapy unit
Operation Manual
BT-400
Keep this manual for future reference
P/N: 400-ENG-OPM-EUR-R12
BT-400 Operation Manu al 1
P/N: 400-ENG-OPM-EUR-R12
Bistos Co., Ltd.
2019.08
Proprietary Material
Information and descrip tion s c ontained in th is m anual are the pr operty of Bistos Co., Ltd.
and may not be copi ed, r ep r oduced, disseminated, or distributed without ex press written
permission from Bistos Co., Ltd
Information furnished by Bistos Co., Ltd is believed to be accurate and reliable. However,
no responsibility is assumed by Bistos for its use, or any infringements of patents or
other rights of third parties that may result from its use. No license is granted by
implication or otherwise under any patent or patent rights of Bistos.
Revision 12
August, 2019
Copyright © Bistos Co., Ltd. 2019. All rights reserved.
7th FL., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnamsi, Gyeonggi-do, Korea
Telephone: ++82 31 750 0340 `
Fax: ++82 31 750 0344
Printed in Korea
BT-400 Operation Manu al 2
P/N: 400-ENG-OPM-EUR-R12
Bistos Co., Ltd.
2019.08
Section 1. Safety Information -----------------------------------------------------------
3
1.1 Instructions for the Safe Operation and Use of BT-400 -----------------------------
3
1.2 General Safety Information------------------------------------------------------------------
4
1.3 General precaution on environment ------------------------------------------------------
6
1.4 Meaning of Symbols -------------------------------------------------------------------------
7
1.5 Button symbols --------------------------------------------------------------------------------
7
Section 2. Product Description --------------------------------------------------------
8
2.1 Intended Use -----------------------------------------------------------------------------------
8
2.2 Physical Characteristics ---------------------------------------------------------------------
8
2.3 Operating Principl e -------------------------------------------------------------------------
8
2.4 Contraindication -----------------------------------------------------------------------------
9
2.5 List of Accessories ----------------------------------------------------------------------------
9
2.6 Appearance of BT-400 -----------------------------------------------------------------------
10
Section 3. Installation and Connection ----------------------------------------------
12
3.1 Installation --------------------------------------------------------------------------------------
12
3.2 Power Connection ----------------------------------------------------------------------------
13
Section 4. Operation -----------------------------------------------------------------------
14
4.1 Operating Method for Control part --------------------------------------------------------
14
4.2 Operating Method for Light Source -------------------------------------------------------
16
4.3 Essential performance -----------------------------------------------------------------------
18
Section 5. Troubleshooting -------------------------------------------------------------
19
Section 6. Cleaning and Maintenance -----------------------------------------------
20
6.1 Checking the Light Intensity-----------------------------------------------------------------
20
6.2 Cleaning------------------------------------------------------------------------------------------
20
6.3 Disposal of the BT-400 ----------------------------------------------------------------------
20
Section 7. Specifications -----------------------------------------------------------------
21
Section 8. Manufacturer’s Declar ation on EMC ----------------------------------
22
Product Guarantee -------------------------------------------------------------------------
26
Reference ---------------------------------------------------------------------------------------------------
26
Table of Contents
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Bistos Co., Ltd.
2019.08
Section1
Safety Information
1.1 Instructions for the Safe Operation and Use of BT-400
BT-400 should be used only appropriately trained personnel and under the direction
of qualified medical personnel familiar with currently known risks and benefits of
infant phototherapy equipment use.
Do not attempt to service the BT-400. Only qualified service personnel by Bistos
Co., Ltd. should attempt any needed internal serv ic ing.
The BT-400 is not specified or intended for operation in conjunction with any other
type of equipment except the specific devices that have been identified for use in
this Operator’s Manual.
Only the AC cord supplied with the BT-400 is approved for use with the Unit.
Monitoring the patient’s status while receiving phototherapy.
Due to photo effects, drugs and infusion liquids shall not be stored in the radiation
area.
Do not touch the equipment with wet hand. There is a risk of electrical shock.
Do not leave the power cable in the place where people or cargo passes through
frequently. There is a possibility that product or person trips on a cable.
While BT-400 is operating, use the eye shield or blindfold to protect eye when the
light for the treatment illuminates other patients. And please check frequently that it
has been worn properly.
When the equipment is about to exceed the useful life, it must be treated in
accordance with relevant local laws and regulations or the hospital's rules and
regulations.
Please unpack carefully to prevent damage. Before unpacking, carefully inspect the
package. If any damage, please immediately contact the Bistos. Unpack in the
correct way, carefully remove the monitor and accessories from the box and check
with the packing list. Check if there is any mechanical damage. When the device is
damaged, do not use it.
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Be informed that it may cause serious injury or death to the
patient, property damage, and material losses
Caution
Background information provided to clarify a particular step or
procedure.
Warning!
CLASS I ME EQUIPMENT - To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth.
Warning!
BT-400 should not be used adjacent to or stack with other devices, unles s verifi cation of
normal operation is completed.
Warning!
Medical electrical equipment needs special precautions regarding EMC and needs to be
equipment.
Warning!
Use of accessories other than those listed and approved for use with this product may
result in increased emissions or decreased immunity.
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,
e of infection. Patients adjacent to the
light may also need to be protected with eye patches or equivalent.
Warning!
Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too
with yellow lenses can alleviate potential
effects.
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.
Symbols Used
The following symbols identify all instructions that are important to safety. Failure to
follow these instructions can lead to injury or damage to the BT-400. When used in
conjunction with the f ol lo wi ng words, t he s ymbols indi c ate:
Warning
Be informed that it may cause no harm in life but lead to injury
NOTE
installed and put into service according to the EMC information provided in this manual. In
addition, portable and mobile RF communications equipment can effect medical electrical
verify that the baby’s eyes are protected and fre
long in the irradiated area. Wearing glasses
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Warning!
Photoisomers: Bilirubin Photoisomers may cause toxic effects.
Warning!
Water balance: Some patients’ water balance may be disturbed.
Warning!
The unit can be tumbled at surface inclined more than 10 degrees .
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.
Warning!
Even though she/he is an adult, the operator may experience some effects if
she/he stays longer in the area irradiated by phototherapy
Warning!
Do not use flammable solution directly to the LED lamps. It may cause of degradation or
aning or maintenance, please follow the instruction
described in Section 6 of this manual.
Warning!
Incorrect use of the LED, or the use of parts and accessories that are not manufactured of
may cause injury to the patient
and/or user.
Warning!
When attaching light to any floor stand, other than Bistos Roll Stand, confirm weight
capacity of stand.
Warning!
Use of reflective foils may cause hazardous body temperatures when the type of
phototherapy influences radiation.
damage on the LED lamps. For cle
supplied by Bistos Co., Ltd can damage the light, and
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Warning!
Blue light can hinder clinical observations by masking skin color changes, such as
cyanosis.
Warning!
Infants who receive phototherapy and have an elevated direct-reacting or conjugated
bilirubin level (cholestatic jaundice) may develop the bronze-baby syndrome.
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1.3 General precaution on environment
Do not keep or operate the equipment under the environment listed below.
Avoid placing in an
area exposed to
moisture. Do not touch
the equipment with
Avoid exposure to
direct sunlight
wet hand.
Avoid placing in an
area where there is a
high variation of
temperature.
Operating temperature
ranges from 10°C to
40°C. Operating
Avoid in the vicinity
of Electric heater
humidity ranges from
5% to 85%.
Avoid placing in an
area where there is an
excessive humidity rise
or ventilation problem.
Avoid placing in an
area where chemicals
are stored or where
there is in danger of
gas leakage.
Do not disjoint or
disassemble the
equipment.
BISTOS Co., Ltd. does
not take responsibility
of it.
Avoid placing in an
area where there is
an excessive shock
or vibration.
Avoid dust and
especially metal
material into the
equipment.
Power off when the
equipment is not fully
installed.
Otherwise, the
equipment could be
damaged.
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Symbol
Meaning
The wrong operating and controlling the device might be cause
an undesirable consequence.
Refer to operation manual. Read manual before placing the
device.
Always protect the Infant’s eyes with eye patches or equivalent.
- IEC 60878
This symbol indicates that BT-400 can overbalance when in any
horizontal plane.
This symbol indicates the Authorized Representative in
European Community of manufacturer.
This symbol indicates that the device contains an object which is
capable of being recycled.
This symbol indicates the temperature limitation for operation,
transport and storage
This symbol indicates the humidity limitation for operation,
transport and storage.
This symbol indicates the maximum number of identical
This symbol indicates the maximum stacking load permitted on
The product is in conformity with European Medical Directive
93/42/EEC. This has been verified by a notified body.
1.4 Meaning of Symbols
transport position on a plane inclined at an angle of 10° from the
Never step on surface of device.
This symbol indicates the manufacture.
This symbol indicates manufacturer’s serial Number of device.
This symbol indicates the production date
This symbol indicates to keep the device dry.
This symbol indicates the correct upright position of package.
This symbol indicates the device is fragile.
packages which may be stacked on one another.
the transport package.
1.5 Button symbols
Symbol Meaning
Power ON/OFF
Add an hour setting time in Timer mode
Remove a half-hour setting time in Timer mode
Stop the device and keep power ON
LED Control(ON, Intens it y control, Pause)
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Note
Section 2
Product Description
BT-400 Phototherapy Unit consists of two parts – Phototherapy light source (Main
Body) and the Roll stand.
2.1 Intended Use
BT-400 Phototherapy light is intende d for treatment of neonatal hyperbi lirubinemia. The
light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
The equipment is usef ul for an infant who is up to the age of thr ee months and a weight
less than 10 kg.
Before use, read this entire manual carefully. There are safety considerations
that should be read and understood before use
2.2 Physical Characterist i cs
BT-400 Phototherapy Unit is a floor-stand ing, mobile phototherap y light that delivers a
narrow band of high-intens ity blue light via blue light emitting diodes (LEDs) to provide
treatment for neonatal hyperbilirubinemia.
2.3 Operating Principle
Light Source(Main Body)
The light consists of a light weight pl astic lig ht encl ose and po wer ass embly. When used
with the Roll Stand, the light can be adjusted bot h horizontally and vertically on the roll
stand assembly.
The Phototherapy light can be used independently from the Roll Stand. In this case,
joint assembly can be used to fix the light source.
Blue LEDs emit light in the range of 400 – 550 nm (peak wavelength 450 – 475 nm).
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Warning!
Eye protection: Do not look directly into the LEDs. During treatment, always
equivalent.
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 em it significant energy in th e 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.
When using phototherapy, protective eyeshades must be used to protect the infant’s
eyes from excessive light exposure.
protect the baby’s eye wit h patches or equivalent. Periodicall y and/or per your
hospital protocol, v erify that the bab y’s eyes are protected and f ree of infection.
Patients adjacent to the light m ay also need t o be protected with e ye patch es or
LEDs have minim al light ou tput degrada tion over the ir lif etim e with prop er use. The l ight
is expected to operate as specified approximat ely 100, 000 hour s .
2.4 Contraindication
Phototherapy is contr aindic ated in infants with c ongen ital por ph yria or a fam ily histor y of
porphyria and those treated with photosensitizing drugs or agents.
2.5 Configuration
Main unit: Main Body+Control part Roll Stand(Optional) Disposable eye shield patch
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Caution!
2.6 Appearance of BT-400
The BT-400 phototherapy system includes the components shown in the f ollo win g f igur e.
2.6.1 Description of Each Part of BT-400
Fig1. Main Unit and Roll Stand
① Light Source: The light can be adjusted both horizontally and vertically on t he 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, key button and LCD
displays. Especially, LCD window shows operating hours, status and information.
④ Height Adjustment Knob: The knob allows you to adjust the height of the light source.
First loosen the k nob, the n adj us t th e he ight of the light, and f inal ly tighten the k no b to
lock the height.
⑤ Roll Stand (Optional)
When you use roll s tand , p l eas e f ix it by using the lock ing d ev ice t hat is at tac he d
to casters. Otherwise, personal injury or equipment damage could occur.
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2.6.2 Description of Display and Control part of BT-400
Fig1. Display and control part
① LCD: Display the status information.
② Power button: Power ON/OFF.
③ Operating button : Time Setting and intensity of LED lights Control
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Caution!
Section 3
Installation and Connection
3.1 Installation
The System consists of two products shipped in two separate boxes. One box c ontains
the light source assembly and the other box contains the Roll Stand.
Refer to assembly instructions enclosed in the Roll Stand.
1. Check the components
2. To combine the main unit and
roll stand, screw the 5mm M5
hexagonal volt clockwise using
2.5 mm wrench
Note: Be sure to check the
mounting normal direction.
Main body is possible to adjust
the height and rotate by using
hinge structure. Please be used
with fixed position to the correct
direction.
To install the BT-400 in desired place, you should lock the two cast ers on the stand. To
lock a caster, lower the sto pper on the cas ter to th e lock ing position. To unlock a caster,
raise the stopper.
You should lock the casters on the roll stand. If you lose the balance of the
equipment, personal injury or equipment damage could occur.
3.2 Power Connection
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Warning!
The following figure shows the power assembly.
The device is required an AC power source of 100V to 240V and 50/60 Hz as an input
power source.
1) While tilting the clip for fixing cables to the side, plug in the power cord into the
inlet of the device.
2) Fasten the clip again to prevent the breakaway of power cord.
Disconnect electrical power: Always switch off the power and disconnect the
power cord when cleaning the light.
Only the AC cord supplied with the BT-400 is approved for use with the unit.
Do not connect the power cord with wet hands.
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Section 4
Item
Icon
Meaning
No.
Item
Phototherapy
Baby Icon
4.1 Operating Method for Control part
4.1.1 Display
Operation
①
4.1.2 Icons
Mode
information
Operating
Information
②
③
④
⑤
⑥
⑦
Continuous mode
LED High intensity (maximum)
LED Low intensity (minimum )
⑧
Timer mode
LED OFF
Mode Information
Operating Information
Setting Time
Remaining Time
Operating Time
Operating Status
LED Driving Time
LED pause
LED OFF and pause
Operating
Status
LED maximum intensity
LED minimum intensity
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Mode
Meaning
Continuous Mode
LED status is ongoing until the user stops the device.
Timer Mode
LED operating is stopped automatically after setting time.
4.1.3 Operating Mode
4.1.4 Operating Method
(1) Power ON /OFF
1) Turn on or off the power by pressing button.
<Booting screen> <Initial screen after booting>
(2). Mode setting
1) Timer mode
① Set the operating time by pressing or button.
② LED is stopped automatically after setting time.
<Timer mode screen>
2) Continuous mode
① buttons can be used to enter the Continuous mode.
<Continuous mode screen>
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(3) LED Control
1) LED ON
① In LED OFF or pause status, LED can be on high intensity by pressing
button.
2) Intensity Control
① In LED ON(maximum intensity), LED intensity can be changed to low by
pressing button.
3) Pause
① In LED O N(low intensity), LED and Timer can be paused b y pressing
button.
4) Stop
① Off the LED and initiali ze the operating and s etting time by pressing
button.
② Timer mode is automatically switched to Continue mode.
(4). LED Operating Time Initialization
1) Press and buttons at the same time when the device is OFF.
2) Then, LED operating time is initialized with turing the device ON.
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Warning!
The infant's body tem perature may be increased a bit when BT-400 is used in
such as the infant incubator,
devices has to be reduced according to the body temperature measurements.
Warning!
Eye protection: Do not look directly into the LEDs. During treatment, always
equivalent.
4.2 Operating Method for Light Source
1. Check Intensity: Before use, check the intensity of the light using a
spectrophotometer. The light prov ides the range of i ntensity from 25 ㎼/㎝
to 55 ㎼/㎝
2
/㎚ at 40㎝(16 inches) distance from the baby.
2. Prepare infant: Infant m a y lie in an open cr ib, a bas sinet, an infant incubat or, or
under an infant radiant warmer.
combination with the warming therapy devices
infant transport incubators an infant radiant warmer or devices supplying heat via
blankets, pads or mattress.
Please note that the use of the baby controlled mode of these warming therapy
devices is recommended when BT-400 is used in combination with one of these
devices, otherwise the set air temperature or the heater output of these warming
3. Shield infant’s eye with protective eye shields designed for use during
phototherapy.
2
/㎚
protect the baby’s eye wit h patches or equivalent. Periodicall y and/or per your
hospital protocol, v erify that the bab y’s eyes are protected and f ree of infection.
Patients adjacent to the light m ay also need to be pr otected with e ye patch es or
4. Position light over inf ant. Position the face of the l ight source no closer to the
infant than 40 ㎝(16 inches). If the light source is far from effective surface,
radiation intensity lowers.
5. Check the size of the effective surface and its position
< Effective Surface Area>
6. Switch on the power by using the power switch at the control part.
7. Monitoring the patient during treatment.
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Warning!
Regular monitoring during treatment is recommended. Use the following
exposed to light.
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.
- Closely monitoring the infant's status including temperature, water balance
while receiving phototherapy, and signs suggestive of early bilirubin
encephalopathy such as changes in sleeping pattern, deteriorating feeding
pattern, or inability to be consoled while crying.
- Do not let the patient depart from the effective surface area of the light.
Changing the infant’s posture every 2 to 3 hours may maximize the area
8. When finished, switch the power off and remove light from the therapy area.
4.3 Essential performance
– Blue LEDs emit light in the range of 400nm ~ 550nm
(peak between 450 – 475nm) for neonatal jaundice treatment
– Irradiance level 25 ~ 55 µW/cm² at 40 cm (16 inches) distance from light source
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Warning!
Warning!
Do not attempt to serv ice the BT-400. Only qualif ied service per sonnel by Bistos Co.,
SVM-EUR-XX.
Problem
Possible Cause
Action
Section 5
Troubleshooting
Disconnect power cord before opening the light for repair.
Ltd. should attempt an y needed internal servicing ref er to service manual 400-ENG-
No power
The unit does not
turn on.
Some LEDs are not
lit.
The light source
enclosure is heated
more than 50℃.
※
It is recommended that the intensity of the light should be checked after partly or
whole changing LED.
Defective MAIN PCB
Defective power supply
One LED may have
burned out causing 4
LEDs to go off.
The current is adjusted
too high.
Constant current circuit
is broken.
Ensure that the power cord is
plugged in correctly.
Have a qualified technician check
the components and replace as
necessary.
Have a qualified technician check
the PCB and replace as necessary.
- Check the connection first.
- Choose the defective LEDs. And
then replace the relevant LEDs.
- Have a qualified technician check
the LED PCB and replace as
necessary.
Have a qualified technician check
the LED and Main PCB and replace
as necessary.
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Warning!
Only qualified person nel shoul d perform service an d repair, and then the light sh ould
be readjusted.
Caution!
All LEDs must be changed at the sam e tim e. And LEDs recomm ended b y Bistos Co.,
the phototherapy
Warning!
Disconnect light from AC powercord before cleaning.
Caution!
Observe the following precautions;
(eg. Phenols, Formyl, Glutaraldehyde, Chlorhexidine, Strong organic acids, etc.,)
Section 6
Maintenance and Cleaning
6.1 Checking the Light Intensity
It is recommended that the intensity of the light should be check ed every 10,000 hours
use by the qualified technician. Also, we recommend that you should change LED lamps
after using 100,000 hours.
Have a qualified technician test the intensity level and readjust the intensity
potentiometers to achieve the desired output, if required.
Ltd. shall be used, and us e of other LEDs can influence safet y and effectiveness of
6.2 Cleaning and Disinfection
Cleaning: Remove dust from the exterior of the light with a soft brush or soft cloth
dampened with water. Turn off and unplug the unit before cleaning.
Clean the remaining debris with a mild solution of detergent and water, a
noncaustic commercial cleaner, or hospital disinfectant.
Disinfection: Always observe the hygiene regulations of the hospital when handling
devices which are contaminated with bodily fluids or other.
If necessary, use the disinfected products based on
- Ethylic alcohol 70% or isopropyl alcohol 70%
- 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.
Important : Some chemical substances contained in cleaning and disinfecting
products can affect the dev ice. Exposition to t hese substances m ay cause damages
on material, which are not always visi ble. Ther efore, it is unad visable t o use clea ning
and disinfecting products whose chemical composition contains.
- Sodium hypochlorite 500 ppm
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6.3 Disposal of the BT-400
When disposing of the BT-400, adhere to all applicable laws regarding recycling. If you
are not able to dispose the BT-400 or you need a help for disposing the BT-400, pl ease
contact us. In case there are no appropriate wa ys to dis pos e, we will pick up the BT-400
for you.
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Functional Characteristics
Light Source
Function
Type
Blue LED (8ea)
Uniform Distribution Intensity
Peak Between
450 ~ 475nm
Intensity
Variation in
Intensity
±10% (over 6hrs within
effective surface area)
Effective
Surface Area
Display
Heat output at 40cm over 6hrs
Noise at 40cm
< 30 dB
Power
Voltage
Input : AC 100 ~ 240V
(50/60Hz)
Standard Configuration
Main unit
1ea
Eye shielder
2ea
Operation
manual
Options
Cart
Shade
Warranty
Physical Characteristics
Dimension
Weight
525.5(W) x 430(D)
x1770(H)mm
541.6(W) x 370(D) x
568.9(H)mm
Main Unit
Packing
575(W) x 300(D) x
245(H)mm
Main Unit
Packing
525.5(W) x 430(D) x
1150(H.MAX.)mm
545(W) x 435(D) x
150(H)mm
Environmental Conditions
Temperature
10 ~ 40°C (50 ~ 104°F)
Temperature
–20 ~ 60°C (–4 ~ 140°F)
5 ~ 85%, noncondensing
Pressure
80 ~ 106 kPa
Pressure
70 ~ 106 kPa
Section 7
Specifications
Wavelength
40 x 20cm Timer 30min ~ 999hrs/30min
LED Life Time 100,000hrs Operating & Total Using Time Display
LCD 2.4" TFT Color LCD
Power Cord 1ea
Main Unit 2years
Assembled
(at 40cm)
< 10 ℃ warmer than ambient
Consumption 70VA
Assembled 12.0Kg
Low : 25 ~ 35µW/cm²
High : 35 ~ 55µW/cm²
1ea
Main Unit
Cart
Cart Packing
Operation Transport & Storage
Humidity
Main Unit 3.3Kg
5.1Kg
Cart 8.5Kg
Cart Packing 9.8Kg
Humidity 0 ~ 95% non-condensing
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Certificates
Standard
IEC60601-1,
IEC60601-1-2
IEC60601-2-50
Certificates KFDA, CE
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Emissions test
Compliance
Electromagnetic environment -
RF emissions
Group 1
The BT-400 uses RF energy only for its
RF emissions
Class A
The BT-400 is suitable for use in all
Harmonic emissions
Class A
Voltage fluctuations /
Complies
Section 8
Manufacturer’s Declaration on EMC
The BT-400 is intended for use in the electromagnetic environment specified below.
The customer or the user of the BT-400 should assure that it is used in such an
environment.
8.1 Disposal of the BT-400
guidance
CISPR 11
CISPR 11
IEC 61000-3-2
flicker emissions
IEC 61000-3-3
internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
establishments other than domestic, and
may be used in domestic establishments
and those directly connected to the
public low-voltage power supply network
that supplies buildings used for domestic
purposes, provided the following
warning is heeded:
Warning: This BT-400 is intended for
use by healthcare professionals only.
This equipment/ system may cause
radio interference or may disrupt the
operation of nearby equipment. It may
be necessary to take mitigation
measures, such as re-orienting or
relocating the BT-400 or shielding the
location.
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2019.08
Test level
Compliance level
environment -guidance
Electrostatic
±8 kV Contact
±8 kV Contact
Floors should be wood,
Electrical fast
±2 kV for power
±2 kV for power
Mains power quality
Surge
±1 kV line(s) to
±1 kV line(s) to
Mains power quality
Power frequency (50
30 A/m
30 A/m
Power frequency magnetic
environment.
Voltage dips, short
Voltage Dip
Voltage
Interruption
Voltage Dip
Voltage
Interruption
т )
Mains power quality
8.2 Electromagnetic immunity
Immunity test
IEC 60601
Electromagnetic
discharge (ESD)
IEC 61000-4-2
transient/burst
IEC 61000-4-4
IEC 61000-4-5
Hz and 60 Hz)
magnetic field
IEC 61000-4-8
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
±2, ±4, ±8, ±15
kV air
supply lines
line(s)
±2 kV line(s) to
earth
< 5 % Uт
(> 95 % dip in
Uт) for 0.5 and 1
cycle
40 % Uт
(60 % dip in Uт )
for 5 cycles
70 % Uт
(30 % dip in Uт)
for 25 and 30
cycles
<5 % Uт
(> 95 % dip in
Uт ) for 250 and
300 cycles at
50Hz, 60Hz
respectively
±2, ±4, ±8, ±15
kV air
supply lines
line(s)
±2 kV line(s) to
earth
< 5 % Uт
(> 95 % dip in
Uт) for 0.5 and 1
cycle
40 % Uт
(60 % dip in Uт )
for 5 cycles
70 % Uт
(30 % dip in Uт)
for 25 and 30
cycles
<5 % Uт
(> 95 % dip in U
for 250 and 300
cycles at 50Hz,
60Hz respectively
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
should be that of a typical
commercial or hospital
environment.
should be that of a typical
commercial or hospital
environment.
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
should be that of a typical
commercial or hospital
environment. If the user of
the BT-400 image
intensifier requires
continued operation
during power mains
interruptions, it is
recommended that the
BT-400 image intensifier
be powered from an
uninterruptible power
supply.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
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2019.08
Compliance
level
Electromagnetic environment
- guidance
Portable mobile RF
NOTE 1) At 80 MHz and 800 MHz, the higher frequency range applies.
affected by absorption and refl ecti on from structures, objects and people.
a
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
8.3 Electromagnetic immunity
Immunity test IEC 60601 test level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
communications equipment
should be used no closer to any
part of the BT-410, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as deter-mined by
an electromagnetic site survey,
should be less than the
compliance level in each
frequency range.
b
Interference may occur in the
vicinity of equipment marked
with the following symbol :
a
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
If the measured field strength in the location in which the BT-410 is used exceeds the
applicable RF compliance level above, the BT-410 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the BT-410.
b
BT-400 Operation Manu al 28
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2019.08
The BT-400 is intended for use in an electromagnetic environment in which radiated RF
Separation distance according to frequency of
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73 1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
8.4 Recommended separation distances between portabl e and mobile RF
communications equipment and the BT-400
disturbances are controlled. The customer or the user of the BT-400 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the BT-400 as recommended
below, according to the maximum output power of the communications equipment.
transmitter [m]
Rated maximum
output power of
transmitter [W]
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1) At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
BT-400 Operation Manu al 29
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2019.08
Product Name
Neonatal phototherapy unit
Model Name
BT-400
Approval No.
Approval Date
Serial No.
Warranty Period
2 Years
Date of Purchase
Hospital:
Telephone:
Sales Agency
Manufacture
Bistos Co., Ltd
Product Guarante e
Customer
Address:
Name:
※ 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 “Framework Act on Consumers” noticed by Fair Trade Commission of
Republic of Korea.
Reference:
1. American Academy of Pediatrics, Subcommittee on Hyperbilirubinema. Clinical Prac tive G uideline_Management of Hyperbilirubinemia
in the Newborn Infant 35 or More Weeks of Gestation [Published correction appears in Padiatrics. 2004; 114(4):1138]. Pediatrics.
2004;114(1):297-316
2. American Academy of Pediatrics, The committee on fetus and newborn. Technical Re port_
Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Copyright © 2011 by the American Academy of Pediatrics.
ISSN Numbers: Print, 0031-4005; Online, 1098-4275
Phototherapy to Prevent Severe Neonatal
BT-400 Operation Manu al 30
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2019.08
Service Telephone and Fax . Numbers
Telephone: +82 31 750 0340
th
FL., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro,
7
Jungwon-gu, Seongnam -si, Gyeonggi-do, Korea
1030 Brussels, BELGIUM
Telephone: + (32) 2. 732.59.54
Fax: +82 31 750 0344
Bistos Co., Ltd.
www.bistos.co.kr
bistos@bistos.co.kr
Obelis s.a
Bd. Général Wahis 53
Fax.: + (32) 2.732.60.03
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