Bistos BT-400 User manual

BT-400
Neonatal Phototherapy unit
Operation Manual
BT-400
Keep this manual for future reference
P/N: 400-ENG-OPM-EUR-R09

BT-400 Operation Manual 1
P/N: 400-ENG-OPM-EUR-R09
Bistos Co., Ltd.
2018,03
Proprietary Material
Information and descriptions contained in this manual are the property of Bistos Co., Ltd.
and may not be copied, reproduced, disseminated, or distributed without express 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 09
Mar,2018
Copyright © Bistos Co., Ltd. 2017. All rights reserved.
7th FL., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-
si, Gyeonggi-do, Korea
Telephone: ++82 31 750 0340 `
Fax: ++82 31 750 0344
Printed in Korea

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2018,03
Table of Contents
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 Principle -----------------
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 ----------------------
17
Section 5. Troubleshooting -----------------------
18
Section 6. Cleaning and Maintenance -----------------
19
6.1 Checking the Light Intensity----------------------
19
6.2 Cleaning-------------------------------------
19
6.3 Disposal of the BT-400 -------------------------------
19
Section 7. Specifications -----------------
20
Section 8. Manufacturer’s Declaration on EMC -----------------
21
Product Guarantee -----------------
25

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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.
Do not attempt to service the BT-400. Only qualified service personnel by Bistos
Co., Ltd. should attempt any needed internal servicing.
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.
Use of reflective foils may cause hazardous body temperatures when the type of
phototherapy influences radiation.
The patient’s bilirubin values shall be measured regularly.
Blue light can hinder clinical observations by masking skin color changes, such as
cyanosis.
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.
Only the AC cord supplied with the BT-400 is approved for use with the Unit.
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.
Wear the eye shield or blindfold to protect patient’s eye and please check frequently
that it has been worn properly.
Please monitor periodically that patients under light irradiation do not depart from
the effective surface area of the light.
Even though she/he is an adult, the operator may experience some effects if she/he
stays longer in the area irradiated by phototherapy.
While BT-400 is operating, use the eye shield or blindfold to protect eye when the
light for the treatment illuminates other patients.

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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 following words, the symbols indicate:
Warning
Be informed that it may cause serious injury or death to the
patient, property damage, and material losses
Caution
Be informed that it may cause no harm in life but lead to injury
NOTE
Background information provided to clarify a particular step or
procedure.
Warning!
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, unless verification of
normal operation is completed.
Warning!
Medical electrical equipment needs special precautions regarding EMC and needs to be
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
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,
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!
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.

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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.
Caution!
Do not use flammable solution directly to the LED lamps. It may cause of degradation or
damage
on the LED lamps. For cleaning or maintenance, please follow the instruction
described in Section 6 of this manual.
Caution!
Incorrect use of the LED, 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.
Caution!
When attaching light to any floor stand, other than Bistos Roll Stand, confirm weight
capacity of stand.

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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
wet hand.
Avoid exposure to
direct sunlight
Avoid placing in an
area where there is a
high variation of
temperature.
Operating temperature
ranges from 10°C to
40°C. Operating
humidity ranges from
5% to 85%.
Avoid in the vicinity
of Electric heater
Avoid placing in an
area where there is an
excessive humidity rise
or ventilation problem.
Avoid placing in an
area where there is
an excessive shock
or vibration.
Avoid placing in an
area where chemicals
are stored or where
there is in danger of
gas leakage.
Avoid dust and
especially metal
material into the
equipment.
Do not disjoint or
disassemble the
equipment.
BISTOS Co., Ltd. does
not take responsibility
of it.
Power off when the
equipment is not fully
installed.
Otherwise, the
equipment could be
damaged.

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1.4 Meaning of Symbols
Symbol
Meaning
Caution is necessary when operating the device or control in
order to avoid undesirable consequences.
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
transport position on a plane inclined at an angle of 10° from the
horizontal plane.
Never step on surface of device.
This symbol indicates the manufacture.
This symbol indicates manufacturer’s serial Number of device.
This symbol indicates the Authorized Representative in
European Community of manufacturer.
This symbol indicates to keep the device dry.
This symbol indicates the correct upright position of package.
This symbol indicates the device is fragile.
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
packages which may be stacked on one another.
This symbol indicates the maximum stacking load permitted on
the transport package.
The product is in conformity with European Medical Directive
93/42/EEC. This has been verified by a notified body.
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, Intensity control, Pause)

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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 intended for treatment of neonatal hyperbilirubinemia. The
light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
Note
Before use, read this entire manual carefully. There are safety considerations
that should be read and understood before use
2.2 Physical Characteristics
BT-400 Phototherapy Unit 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 Operating Principle
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 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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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.
When using phototherapy, 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
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 100,000 hours.
2.4 Contraindication
Phototherapy is contraindicated in infants with congenital porphyria or those treated with
photosensitizing drugs.
Based on the PEDIATRICS (ISSN Numbers: Print, 0031-4005;Online, 1098-4275). Copyright © 2011 by
the American Academy of Pediatrics
2.5 List of Accessories
Main Body + Control part Roll Stand(Optional) Disposable eye shield patch

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2.6 Appearance of BT-400
The BT-400 phototherapy system includes the components shown in the following figure.
2.6.1 Description of Each Part of BT-400
Fig1. Main body and Roll Stand
①Light 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.
②Adjustable Neck
③Control Box (Power Assembly): It contains power switch, key button and LCD
displays. Especially, LCD window shows operating hours, status and information.
④Height 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.
⑤Roll Stand (Optional)
Warning!
When you use roll stand, please fix it by using the locking device that is attached
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
①LCD: Display the status information.
②Power button: Power ON/OFF.
③Operating button : Time Setting and intensity of LED lights Control

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Section 3
Installation and Connection
3.1 Installation
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.
Refer to assembly instructions enclosed in the Roll Stand.
1. Check the components
2. To combine the main body
assembly 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 casters on the stand. To
lock a caster, lower the stopper on the caster to the locking position. To unlock a caster,
raise the stopper.
Warning!
You should lock the casters on the roll stand. If you lose the balance of the
equipment, personal injury or equipment damage could occur.

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3.2 Power Connection
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.
Warning!
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
Operation
4.1 Operating Method for Control part
4.1.1 Display
4.1.2 Icons
Item
Icon
Meaning
Mode
information
Continuous mode
Timer mode
Operating
Information
LED OFF
LED High intensity (maximum)
LED Low intensity (minimum)
LED pause
Operating
Status
LED OFF and pause
LED maximum intensity
LED minimum intensity
No.
Item
①
Phototherapy
Baby Icon
②Mode Information
③Operating Information
④
Setting Time
⑤Remaining Time
⑥Operating Time
⑦Operating Status
⑧LED Driving Time

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4.1.3 Operating Mode
Mode
Meaning
Continuous Mode LED status is ongoing until the user stops the device.
Timer Mode LED operating is stopped automatically after setting time.
4.1.4 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
2.1 Timer mode
1) Set the operating time by pressing or button.
* LED is stopped automatically after setting time.
<Timer mode screen>
2.2 Continuous mode
* and buttons are not used in Continuous mode
<Continuous mode screen>
3. LED ON, Pause and Intensity Control
3-1. LED ON
1) In LED OFF or pause status, LED is on by pressing button.
(LED is maximum intensity.)

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3-2. Intensity Control
1) In LED ON(maximum intensity), press button.
(LED intensity changes to minimum.)
3-3. Pause
1) In LED ON(minimum intensity), press button.
4. Stop
1) Initialize the LED OFF and setting time by pressing button.
* Timer mode is switched automatically to Continue mode.
5. LED Operating Time Initialization
1) Press and buttons at the same time in power OFF.
2) Then, power is ON and LED operating time is initialized.
4.2 Operating Method for Light Source
1. Check Intensity: Before use, check the intensity of the light using a
spectrophotometer. The light provides the range of intensity from 35 ㎼/㎝2/㎚
to 55 ㎼/㎝2/㎚at 40㎝(16 inches) distance from the baby.
2. Prepare infant: Infant may lie in an open crib, a bassinet, an infant incubator, or
under an infant radiant warmer.
Caution!
Please note that the set air temperature of incubator or heater output of infant
radiant warmer or heated mattress may be reduced when BT-400 is used in
combination with one of these therapy devices.
Caution!
Please note that the infant's body temperature may be increased a bit when BT-
400 is used in combination with the warming therapy devices.
Use of the baby
controlled mode of the warming therapy device is recommended when the
phototherapy is used in combination; otherwise the set air temperature of the
incubator or the heater output has to be reduced according to the body
temperature measurements.

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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 t
o 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). If the light source is far from effective surface,
radiation intensity lowers.
5. Check the size of the effective surface and its position
c
< Effective Surface Area>
6. Switch on the power, using the power switch at the control part.
7. Monitoring the patient during treatment.
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.
-
Use of the baby controlled mode of the warming therapy device is
recommended when the phototherapy is used in combination; otherwise the
set air temperature of the incubator or the heater output has to be reduced
according to the body temperature measurements.
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 jaundice treatment
– Positioning the light source no closer to the infant that 40cm (16 inches)
– System must remain in a safe condition according to IEC60601-1.

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Section 5
Troubleshooting
Warning!
Disconnect power cord before opening the light for repair.
Warning!
Do not attempt to service the BT-400. Only qualified service personnel by Bistos Co.,
Ltd. should attempt any needed internal servicing refer to service manual 400-EN-
SVM.
Problem
Possible Cause
Action
The unit does not
turn on.
No power Ensure that the power cord is
plugged in correctly.
Defective MAIN PCB Have a qualified technician check the components and replace as
necessary.
Defective power supply Have a qualified technician check
the PCB and replace as necessary.
Some LEDs are not
lit.
One LED may have
burned out causing 4
LEDs to go off.
- 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.
The light source
enclosure is heated
more than 50℃.
The current is adjusted
too high.
Constant current circuit
is broken.
Have a qualified technician check
the LED and Main PCB and replace
as necessary.
※ It is recommended that the intensity of the light should be checked after partly or
whole changing LED.

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Section 6
Maintenance and Cleaning
6.1 Checking the Light Intensity
It is recommended that the intensity of the light should be checked 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.
Note
All LEDs must be changed at the same time. And LEDs recommended by Bistos Co.,
Ltd. shall be used, and use of other LEDs can influence safety and effectiveness of
the phototherapy
Caution!
Only qualified personnel should perform service and repair, and then the light should
be readjusted.
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 products based on
- Ethylic alcohol 70% or isopropyl alcohol 70%
- Sodium hypochlorite 500 ppm
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.
Important : Some chemical substances contained in cleaning and disinfecting
products can affect the device. Exposition to these substances may cause damages
on material, which are not always visible. Therefore, it is unadvisable to use cleaning
and disinfecting products whose chemical composition contains.
(eg. Phenols, Formyl, Glutaraldehyde, Chlorhexidine, Strong organic acids, etc.,)
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, please
contact us. In case there are no appropriate ways to dispose, we will pick up the BT-400
for you.